1. NEW YORK and LONDON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, will host a conference call and audio webcast on Wednesday, September 8, at 4:15 p.m. ET to discuss its recently announced exclusive license agreement to evaluate Foralumab, the Company's novel, fully human anti-CD3 monoclonal antibody, in conjunction with allogenic CAR T candidates for cancer treatment.

    Date:Wednesday, September 8, 2021
      
    Time:4:15 p.m. Eastern Time
      
    Live Call:+1-877-407-9716 (U.S. Toll-Free) or +1-201-493-6779 (International)
      
    Webcast:http://public.viavid.com/index.php?id=146493

    NEW YORK and LONDON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, will host a conference call and audio webcast on Wednesday, September 8, at 4:15 p.m. ET to discuss its recently announced exclusive license agreement to evaluate Foralumab, the Company's novel, fully human anti-CD3 monoclonal antibody, in conjunction with allogenic CAR T candidates for cancer treatment.

    Date:Wednesday, September 8, 2021
      
    Time:4:15 p.m. Eastern Time
      
    Live Call:+1-877-407-9716 (U.S. Toll-Free) or +1-201-493-6779 (International)
      
    Webcast:http://public.viavid.com/index.php?id=146493

    For interested individuals unable to join the conference call, a dial-in replay of the call will be available until September 22, 2021 and can be accessed by dialing +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International) and entering replay pin number: 13722965.

    About Foralumab

    Foralumab (TZLS-401, formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines as compared to other anti-CD3 mAbs after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017 Clin Immunol 183, 240-246). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences



    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries: 
    United Kingdom: 
    Tiziana Life Sciences plc+44 (0)20 7495 2379  
    Gabriele Cerrone, Chairman, and founder 
       
    United States:  
    Investors:  
    Dave Gentry, CEO  
    RedChip Companies Inc.  
    407-491-4498  
    dave@redchip.com    


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  2. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    LONDON and NEW YORK, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Old Tiziana") a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases announced on 20 August 2021 that it had formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd ("New Tiziana

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    LONDON and NEW YORK, Sept. 03, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Old Tiziana") a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases announced on 20 August 2021 that it had formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd ("New Tiziana"), a Bermuda-incorporated company, as the ultimate parent company of the Tiziana Group. The reorganisation will be achieved by a scheme of arrangement under Part 26 of the Companies Act 2006 (the "Scheme").

    A Scheme Document setting out full details of the Scheme (the "Scheme Document"), which includes notices of the court and the general meeting, which are to be held via a virtual meeting platform at 11.00 a.m. and 11.15 a.m. respectively on 27 September 2021, is being posted to the shareholders of Old Tiziana today. The Scheme Document can be found on Old Tiziana's website at http://www.tizianalifesciences.com/about-us/.

    Capitalised terms defined in the Scheme Document shall, unless the context provides otherwise, have the same meanings in this announcement.



    Expected Timetable of Principal Events

    EventExpected time/date
    ADS Voting Record Time



    30 September 2021
    Latest time for receipt by the Depositary of voting instructions from holders of Old Tiziana ADSs for the Court Meeting



    8.00 a.m. (New York time) on 22 September 2021



    Latest time for receipt by the Depositary of voting instructions from holders of Old Tiziana ADSs for the Scheme General Meeting



    8.00 a.m. (New York time) on 22 September 2021



    Latest time for receipt by Old Tiziana's Registrars of Blue Forms of Proxy from Old Tiziana Shareholders for the Court Meeting

     
    11:00 a.m. on 23 September 2021
    Latest time for receipt by Old Tiziana's Registrars of White Forms of Proxy from Old Tiziana Shareholders for the Scheme General Meeting



    11:15 a.m. on 23 September 2021
    Voting record time for the Court Meeting and the Scheme General Meeting



    6:00 p.m. on 23 September 2021
    Court Meeting



    11:00 a.m. on 27 September 2021
    Scheme General Meeting



    11:15 a.m. on 27 September 2021
      
    The following dates are subject to change: 
      
    Court Hearing to sanction the Scheme and the Old Tiziana Reduction of Capital



    19 October 2021
    Scheme Record TimeClose of business on 20 October 2021
    Last day of dealings in, and for registration of transfers of, Old Tiziana ADSs



    20 October 2021
    Last day of dealings in, and for registration of transfers of, Old Tiziana Shares



    20 October 2021
    Scheme Effective Date



    21 October 2021
    Effective date for the Share Capital Consolidation



    Immediately after the Scheme becomes effective on 21 October 2021
    Delisting of Old Tiziana Shares from the Main Market



    8:00 a.m. on 21 October 2021
    Cancellation of listing of Old Tiziana ADSs on NASDAQ



    9.30 a.m. (New York time) on 21 October 2021
    Commencement of trading in the New Tiziana Shares on NASDAQ



    9.30 a.m. (New York time) on 21 October 2021

    For the purposes of UK MAR, the person responsible for arranging for the release of this announcement on behalf of Tiziana is Dr Kunwar Shailubhai, Chief Executive Officer.

    For further information please contact:

    Keeren Shah, Finance Director: +44 (0) 207 495 2379 or email: info@tizianalifesciences.com

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward looking statements

    This announcement may contain certain forward-looking statements. These forward-looking statements include all matters that are not historical facts. These forward-looking statements involve risks and uncertainties that could cause the actual results of operations, financial condition, prospects and the development of the sector in which Old Tiziana operates to differ materially from the impression created by these forward-looking statements. Old Tiziana does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Do not place undue reliance on forward-looking statements, which speak only as of the date of this announcement.



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  3. Precision Gains Access to Tiziana's Anti-CD3 Antibody, Foralumab, to Evaluate as a Lymphodepletion Agent with its Allogeneic CAR T Portfolio

    Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and Tiziana Life Sciences plc (NASDAQ:TLSA), a clinical stage biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy…

    Precision Gains Access to Tiziana's Anti-CD3 Antibody, Foralumab, to Evaluate as a Lymphodepletion Agent with its Allogeneic CAR T Portfolio

    Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and Tiziana Life Sciences plc (NASDAQ:TLSA), a clinical stage biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210901006026/en/

    The Cluster of Differentiation (CD) 3 is a receptor on effector T cells and an anti-CD3 antibody, such as foralumab, has the potential to eliminate or tolerize patient effector T cells. Precision's manufacturing process, which uses ARCUS to knock out the TRAC gene and implements a CD3-depletion step, produces allogeneic CAR T candidates that are >99.9% CD3-negative. Thus, an anti-CD3 antibody, such as foralumab, might be used to enable the CAR T cells to expand, proliferate, and persist to maximize long term clinical benefits.

    Under the terms of the agreement, Precision gains an exclusive license to use foralumab as a lymphodepletion agent in conjunction with its allogeneic CAR T therapeutics for the treatment of cancers. Precision will be responsible for the development, commercialization, and costs for use of foralumab, and Tiziana will receive upfront payment, certain milestone payments, and royalties for foralumab.

    "We are building out an allogeneic CAR T platform with editing strategies and novel conditioning regimens, such as a lymphodepleting agent like foralumab, for a broad range of hematologic malignancies and solid tumors," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "By combining Precision's know-how in constructing novel CAR T products with novel conditioning regimens, we will explore this approach to potentially improve durability of clinical responses to our therapeutic platform."

    "We're pleased to offer Precision the exclusive opportunity to explore foralumab, our fully human anti-CD3 monoclonal antibody, for use as a potential lymphodepletion strategy with their allogeneic CAR T programs," said Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of Tiziana Life Sciences. "While CAR T therapies have been clinically successful, relapse rates remain high, which continues to limit broad utility. We are impressed with Precision's novel approaches to CAR T development, offering the potential for a meaningful off-the-shelf solution. Further, given Precision's approach to manufacturing that produces CAR T cells virtually CD3-negative, we believe use of foralumab as a lymphodepletion or tolerizing agent has the potential, either alone or in combination with other co-stimulatory molecules, to improve the long-term success of CAR T in cancer treatment."

    About Precision's Allogeneic CAR T Platform

    Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The Company's allogeneic CAR T platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then uses its ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, which is designed to create a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

    About Foralumab

    Foralumab (TZLS-401, formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines as compared to other anti-CD3 mAbs after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017 Clin Immunol 183, 240-246). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Precision BioSciences, Inc.

    Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company's pipeline consists of multiple "off-the-shelf" CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences please visit www.precisionbiosciences.com.

    About Tiziana Life Sciences plc

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Precision Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company's agreement with Tiziana for the exploration, use, development or commercialization of foralumab as a lymphodepletion agent in conjunction with the Company's allogeneic CAR T therapeutics for the treatment of cancers and any future milestone or royalty payments thereunder. In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "target," "mission," "may," "will," "would," "should," "could," "target," "project," "predict," "contemplate," "potential," or the negative thereof and similar words and expressions.

    Forward-looking statements are based on management's current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators' ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators' development of product candidates; our or our collaborators' ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators' ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators' ability to enroll patients; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key scientific and management personnel; market and economic conditions; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, as any such factors may be updated from time to time in our other filings with the SEC, and accessible on the SEC's website at www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

    All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Tiziana Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

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  4. DURHAM, N.C. and NEW YORK and LONDON, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and Tiziana Life Sciences plc (NASDAQ:TLSA), a clinical stage biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.

    The Cluster of Differentiation (CD) 3 is a receptor on effector…

    DURHAM, N.C. and NEW YORK and LONDON, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, and Tiziana Life Sciences plc (NASDAQ:TLSA), a clinical stage biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (mAb), as an agent to induce tolerance of allogeneic CAR T cells to potentially improve the clinical outcome of CAR T cell therapy.

    The Cluster of Differentiation (CD) 3 is a receptor on effector T cells and an anti-CD3 antibody, such as foralumab, has the potential to eliminate or tolerize patient effector T cells. Precision's manufacturing process, which uses ARCUS to knock out the TRAC gene and implements a CD3-depletion step, produces allogeneic CAR T candidates that are >99.9% CD3-negative. Thus, an anti-CD3 antibody, such as foralumab, might be used to enable the CAR T cells to expand, proliferate, and persist to maximize long term clinical benefits.

    Under the terms of the agreement, Precision gains an exclusive license to use foralumab as a lymphodepletion agent in conjunction with its allogeneic CAR T therapeutics for the treatment of cancers. Precision will be responsible for the development, commercialization, and costs for use of foralumab, and Tiziana will receive upfront payment, certain milestone payments, and royalties for foralumab.

    "We are building out an allogeneic CAR T platform with editing strategies and novel conditioning regimens, such as a lymphodepleting agent like foralumab, for a broad range of hematologic malignancies and solid tumors," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "By combining Precision's know-how in constructing novel CAR T products with novel conditioning regimens, we will explore this approach to potentially improve durability of clinical responses to our therapeutic platform."

    "We're pleased to offer Precision the exclusive opportunity to explore foralumab, our fully human anti-CD3 monoclonal antibody, for use as a potential lymphodepletion strategy with their allogeneic CAR T programs," said Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of Tiziana Life Sciences. "While CAR T therapies have been clinically successful, relapse rates remain high, which continues to limit broad utility. We are impressed with Precision's novel approaches to CAR T development, offering the potential for a meaningful off-the-shelf solution. Further, given Precision's approach to manufacturing that produces CAR T cells virtually CD3-negative, we believe use of foralumab as a lymphodepletion or tolerizing agent has the potential, either alone or in combination with other co-stimulatory molecules, to improve the long-term success of CAR T in cancer treatment."

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    The person responsible for arranging for the release of this announcement on behalf of Tiziana Life Sciences plc is Dr Kunwar Shailubhai, Chief Executive Officer.

    About Precision's Allogeneic CAR T Platform

    Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully scaled, proprietary manufacturing processes. The Company's allogeneic CAR T platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then uses its ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, which is designed to create a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

    About Foralumab

    Foralumab (TZLS-401, formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines as compared to other anti-CD3 mAbs after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017 Clin Immunol 183, 240-246). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Precision BioSciences, Inc.

    Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company's pipeline consists of multiple "off-the-shelf" CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences please visit www.precisionbiosciences.com.

    About Tiziana Life Sciences plc

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Precision Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company's agreement with Tiziana for the exploration, use, development or commercialization of foralumab as a lymphodepletion agent in conjunction with the Company's allogeneic CAR T therapeutics for the treatment of cancers and any future milestone or royalty payments thereunder. In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "target," "mission," "may," "will," "would," "should," "could," "target," "project," "predict," "contemplate," "potential," or the negative thereof and similar words and expressions.

    Forward-looking statements are based on management's current expectations, beliefs and assumptions and on information currently available to us. Such statements are subject to a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to become profitable; our ability to procure sufficient funding and requirements under our current debt instruments; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the success of our programs and product candidates in which we expend our resources; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities, preclinical or greenhouse studies and clinical or field trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, biotechnology and agricultural biotechnology fields; our or our collaborators' ability to identify, develop and commercialize product candidates; pending and potential liability lawsuits and penalties against us or our collaborators related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators' development of product candidates; our or our collaborators' ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; our or our collaborators' ability to advance product candidates into, and successfully design, implement and complete, clinical or field trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators' ability to enroll patients; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data privacy and security regulations and our compliance therewith; the rate and degree of market acceptance of any of our product candidates; the success of our existing collaboration agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate key scientific and management personnel; market and economic conditions; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events effects of the outbreak of COVID-19, or any pandemic, epidemic or outbreak of an infectious disease; insurance expenses and exposure to uninsured liabilities; effects of tax rules; risks related to ownership of our common stock and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2021, as any such factors may be updated from time to time in our other filings with the SEC, and accessible on the SEC's website at www.sec.gov and the Investors & Media page of our website at investor.precisionbiosciences.com.

    All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Tiziana Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    Precision BioSciences Investor Contact:

    Alex Kelly

    Chief Financial Officer

    Alex.Kelly@precisionbiosciences.com

    Precision BioSciences Media Contact:

    Maurissa Messier

    Senior Director, Corporate Communications

    Maurissa.Messier@precisionbiosciences.com

    Tiziana Life Sciences plc Contacts:

    United Kingdom:

    Gabriele Cerrone

    Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Dave Gentry

    Chief Executive Officer

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com



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  5. LONDON and NEW YORK, Aug. 20, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Old Tiziana") a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases today announces that it has formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd ("New Tiziana"), a Bermuda-incorporated company, as the ultimate parent company of the of the Tiziana Group. The reorganisation will be achieved by a scheme of arrangement under Part 26 of the Companies Act 2006 (the "Scheme").

    As set out below, upon implementation of the Scheme, holders of ordinary shares in Old Tiziana ("Old Tiziana Shares") will receive shares in New Tiziana…

    LONDON and NEW YORK, Aug. 20, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Old Tiziana") a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases today announces that it has formally commenced its strategic plan to change its corporate structure by establishing Tiziana Life Sciences Ltd ("New Tiziana"), a Bermuda-incorporated company, as the ultimate parent company of the of the Tiziana Group. The reorganisation will be achieved by a scheme of arrangement under Part 26 of the Companies Act 2006 (the "Scheme").

    As set out below, upon implementation of the Scheme, holders of ordinary shares in Old Tiziana ("Old Tiziana Shares") will receive shares in New Tiziana ("New Tiziana Shares") in exchange for their Old Tiziana Shares (and Old Tiziana will become a wholly-owned subsidiary of New Tiziana). It is proposed that the New Tiziana Shares will be directly listed on NASDAQ following the Scheme becoming effective. At the same time the Old Tiziana Shares will be delisted from the standard segment of the official list of the Financial Conduct Authority ("FCA") and from trading on the main market of the London Stock Exchange plc in London and the ADSs (each representing two Old Tiziana Shares) will cease trading on NASDAQ. Holders of Old Tiziana Shares and ADSs will instead receive New Tiziana Shares which will only trade on NASDAQ. Details of the Scheme and the required shareholder and court convened meetings to approve it will be sent to shareholders shortly.

    Reasons for the reorganisation

    Following a review of the appropriate place(s) of listing and domicile for the parent company of the Tiziana Group, the board of directors of Old Tiziana (the "Board") has concluded that the interests of its business and shareholders are best served by aligning the place of the listing with the principal business activities of the Tiziana Group, which are predominately based in the US. Therefore, the Board intends to establish a direct listing on NASDAQ. Given this intention, the Board concluded that England was not the most appropriate domicile for the parent company of the Tiziana Group because it is not possible to directly list shares of English companies on NASDAQ.  Therefore, if Old Tiziana remained the parent company of the Tiziana Group, only ADSs in respect of Old Tiziana Shares could be listed on NASDAQ. The Board believes that listing shares on NASDAQ directly, as opposed to maintaining its current listing of ADSs, will provide for greater analyst coverage, liquidity and reduce costs for shareholders. Therefore, the Scheme will establish a new Tiziana Group holding company, New Tiziana, incorporated in Bermuda, with its tax residence in the United Kingdom.  Bermuda is a well-established jurisdiction for companies traded on NASDAQ and New Tiziana Shares can be directly listed on NASDAQ. 

    Overview of the Scheme

    As explained above it is intended that this new corporate structure will be implemented by means of a scheme of arrangement under Part 26 of the Companies Act. The Scheme will be conditional on a number of matters, including shareholder approvals at a meeting to be convened by the Companies Court of England and Wales ("Court Meeting") and a separate general meeting of shareholders ("General Meeting").

    Details of the reasons for the proposals, the Scheme, the Court Meeting and General Meeting will be sent to shareholders shortly.

    The Scheme will require the approval of shareholders at the Court Meeting and the General Meeting. If the Scheme is approved by the requisite majorities at the Court Meeting and the relevant resolutions are passed at the General Meeting (the "Approvals"), an application will be made to the Companies Court of England and Wales to sanction the Scheme.

    If the Scheme is sanctioned by the Companies Court, the Court order sanctioning the Scheme will be delivered to the UK Registrar of Companies at which point the Scheme becomes legally effective.

    At the same time as the Scheme becomes effective the Old Tiziana Shares will be delisted from the standard segment of the official list of the FCA and from trading on the main market of the London Stock Exchange plc in London. The Old Tiziana ADSs will also cease trading on NASDAQ. Holders of all Old Tiziana Shares and ADSs will instead receive New Tiziana Shares, which will only trade on NASDAQ.

    The impact of the Scheme for shareholders

    If the conditions are satisfied and the Scheme is approved and becomes effective, and share capital consolidation (as described below) is implemented, it will result in shareholders of Old Tiziana holding shares in New Tiziana and in Old Tiziana becoming a wholly-owned subsidiary of New Tiziana. Upon the Scheme becoming effective and the share capital consolidation being implemented, Old Tiziana shareholders at the Scheme record time will receive, in exchange for their Old Tiziana Shares, New Tiziana Shares on the following basis, subject to fractional interests, if any:

    for every two Old Tiziana Shares held one New Tiziana Share

    New Tiziana share consolidation

    As part of the Proposals, New Tiziana intends to implement a share consolidation in respect of New Tiziana Shares issued under the Scheme to ensure that the New Tiziana Shares trade initially on NASDAQ at a price more readily comparable to its peers (the "Share Capital Consolidation"). The ratio of the Share Capital Consolidation will be two-for-one. It is intended that the Share Capital Consolidation will be implemented immediately after the Scheme becomes effective. Whilst the Share Capital Consolidation will reduce the number of issued shares of New Tiziana, shareholders will still own the same proportion of New Tiziana immediately after the Scheme becomes effective as they did of Old Tiziana immediately before the Scheme became effective, subject to fractional interests, if any. 

    Fractional entitlements may arise as a result of the Share Capital Consolidation if shareholders hold an odd number of Old Tiziana shares.  For example, as the ratio of the Share Capital Consolidation is two-for-one, then an Old Tiziana shareholder holding 51 New Tiziana shares immediately after the Scheme becomes effective will, after implementation of the Share Capital Consolidation, be entitled to 25 New Tiziana shares and a one-half fractional entitlement to a New Tiziana share. Fractional entitlements of New Tiziana shares shall not be issued and to the extent Old Tiziana Shareholders are entitled to fractional New Tiziana shares, those fractional entitlements will be aggregated by New Tiziana's transfer agent, Computershare, and sold as soon as practicable after the Scheme effective date at the then prevailing prices on the open market and the net proceeds of sale distributed pro rata to the Old Tiziana shareholders entitled to them. 

    Options, warrants and loan notes

    It is the Board's intention that all outstanding options and awards ("Options") pursuant to The Tiziana Life Sciences Plc 2014 Share Option Plan and The Tiziana Life Sciences Plc 2016 Share Option Plan will continue on the same basis, other than that they will ultimately deliver New Tiziana Shares rather than Old Tiziana Shares. Old Tiziana will write to the holders of all outstanding Options on or as soon as reasonably practicable after the date on which the information circular is posted setting out further details of the impact that the Scheme will have in respect of their Options.

    The Scheme will affect the holders of outstanding warrants to subscribe for Old Tiziana Shares ("Old Tiziana Warrants") and loan notes convertible into Old Tiziana Shares ("Old Tiziana Loan Notes"). It is the Board's intention that the Old Tiziana Warrants and the Old Tiziana Loan Notes outstanding at the Scheme effective date will be replaced with equivalent warrants and equivalent loan notes, respectively, that relate to New Tiziana Shares. Old Tiziana will write to the holders of all outstanding Old Tiziana Warrants and Old Tiziana Loan Notes on or as soon as reasonably practicable after the date on which the information circular is posted setting out further details of the impact that the Scheme will have in respect of their Old Tiziana Warrants and Old Tiziana Loan Notes.

    For the purposes of UK MAR, the person responsible for arranging for the release of this announcement on behalf of Tiziana is Dr Kunwar Shalubhai, Chief Executive Officer.

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    For further information please contact:

    Keeren Shah, Finance Director on +44 (0) 207 495 2379 or

    email info@tizianalifesciences.com

    About Tiziana Life Sciences



    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward looking statements

    This announcement may contain certain forward-looking statements. These forward-looking statements include all matters that are not historical facts. These forward-looking statements involve risks and uncertainties that could cause the actual results of operations, financial condition, prospects and the development of the sector in which Old Tiziana operates to differ materially from the impression created by these forward-looking statements. Old Tiziana does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Do not place undue reliance on forward-looking statements, which speak only as of the date of this announcement.



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    • Nasally administered Foralumab, once a day for 10 consecutive days, was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography (CT) scanning
    • This anti-inflammatory effect of treatment was strongly supported by a reduction in serum levels of pro-inflammatory biomarkers Interleukin-6 (IL-6), IL-18 and C-reactive protein (CRP)
    • As a next step, Tiziana will be shortly initiating a Phase 2 Proof-of-concept study in Brazil to evaluate safety, tolerability, and efficacy of intranasal Foralumab in a larger number of hospitalized patients with COVID-19 

    NEW YORK and LONDON, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company…

    • Nasally administered Foralumab, once a day for 10 consecutive days, was well-tolerated and produced significant reduction in lung inflammation as assessed by computerized tomography (CT) scanning
    • This anti-inflammatory effect of treatment was strongly supported by a reduction in serum levels of pro-inflammatory biomarkers Interleukin-6 (IL-6), IL-18 and C-reactive protein (CRP)
    • As a next step, Tiziana will be shortly initiating a Phase 2 Proof-of-concept study in Brazil to evaluate safety, tolerability, and efficacy of intranasal Foralumab in a larger number of hospitalized patients with COVID-19 

    NEW YORK and LONDON, Aug. 17, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces publication of a scientific article in the peer-reviewed journal Frontiers in Immunology titled "Nasal Administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study"(1). The study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA) and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil. The aim of the study was to assess safety of intranasal Foralumab and evaluate its potential benefits in treating immune hyperactivity and lung inflammation in mild to moderate COVID-19 patients who were outpatients at the Santa Casa de Misericordia de Santos Hospital in Brazil. Thirty-nine patients were randomized into three cohorts: no Foralumab treatment (control), nasal Foralumab (100 ug) + Dexamethasone (6 mg orally on days 1-3), and nasal Foralumab (100 ug) alone administered for 10 consecutive days. All arms were allowed to continue standard of care medications. To view the online publication, please click here:

    http://journal.frontiersin.org/article/10.3389/fimmu.2021.709861/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=709861

    Clinical Data

    Treatment with Foralumab was well-tolerated, and all patients completed the study. No serious adverse events were observed. Eleven patients (28%) experienced an adverse event, including headache (n=4), burning in the nostril (n=1), retrosternal pain (n=2), pustular lesions and itching in cervical area (n=1), dysuria (n=1), tachycardia associated with anxiety (n=1), and insomnia (n=1). Treatment with Foralumab resulted in significant reduction in lung inflammation. The CT scan of the lungs obtained prior to the start of treatment and at study completion revealed a marked improvement in clearance of lung infiltrates, predominantly in patients receiving Foralumab alone as compared to patients in the control cohort. The CT scanning data strongly correlated with significant reduction in levels of inflammatory markers, such as IL-6 levels (69%; p=0.031) and CRP (85%; p=0.032) at day 10.

    "Dr. Thais Moreira and other researchers at the Brigham and Women's Hospital (BWH) have been engaged with the development of nasal spray of anti-CD3 monoclonal antibodies for treatment of neurodegenerative diseases. I am pleased our research has led to the development of this novel approach with Foralumab nasal spray for the treatment of COVID-19 patients. This technology is particularly important, because COVID-19 causes immune hyperactivity, and we believe nasal delivery of Foralumab could rapidly suppress inflammation both in the lung and systemically to provide immediate relief to COVID-19 patients," said Professor Howard Weiner, the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center, and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented: "We are very pleased with the publication of the article in a peer-reviewed journal. The clinical findings reported in the article suggest that the nasal spray of Foralumab could be developed as a take home treatment, circumventing the obstacles associated with intravenous treatments for COVID-19 and its variants. We are looking forward to initiating shortly the next clinical study evaluating Foralumab nasal spray in hospitalized COVID-19 patients."   

    Cited Reference

    1.  Moreira TG, Matos KTF, De Paula GS, Santana TMM, Da Mata RG, Pansera FC, Cortina AS, Spinola MG, Keppeke GD, Jacob J, Palejwala V, Chen K, Izzy S, Healey BC, Rezende RM, Dedivitis RA, Shailubhai K and Weiner HL (2021) Nasal administration of Anti-CD3 Monoclonal Antibody (Foralumab) Reduces Lung Inflammation and Blood Inflammatory Biomarkers in Mild to Moderate COVID-19 Patients: A Pilot Study. Front. Immunol. 12:709861. doi: 10.3389/fimmu.2021.709861

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About Foralumab

    Foralumab (TZLS-401, formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines as compared to other anti-CD3 mAbs after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017 Clin Immunol 183, 240-246). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc +44 (0)20 7495 2379  
    Gabriele Cerrone, Chairman and founder  
       
    United States:  
    Investors:  
    Dave Gentry, CEO  
    RedChip Companies Inc.  
    407-491-4498  
    dave@redchip.com  



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  6. London, United Kingdom--(Newsfile Corp. - August 16, 2021) - Tiziana Life Sciences plc (NASDAQ:TLSA) today announced that Dr. Kunwar Shailubhai, CEO & CSO will be attending the Q3 Virtual Investor Summit.

     Event Q3 Investor Summit
     Date August 17-18th, 2021
     Presentation August 18th at 3.30pm ET
     Location https://zoom.us/webinar/register/WN_Az9VTw1QRr6aESxsPWSloQ

     

    About Tiziana Life Sciences plc

    Tiziana Life Sciences plc (NASDAQ:TLSA) (LSE: TILS) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns…

    London, United Kingdom--(Newsfile Corp. - August 16, 2021) - Tiziana Life Sciences plc (NASDAQ:TLSA) today announced that Dr. Kunwar Shailubhai, CEO & CSO will be attending the Q3 Virtual Investor Summit.

     Event Q3 Investor Summit
     Date August 17-18th, 2021
     Presentation August 18th at 3.30pm ET
     Location https://zoom.us/webinar/register/WN_Az9VTw1QRr6aESxsPWSloQ

     

    About Tiziana Life Sciences plc

    Tiziana Life Sciences plc (NASDAQ:TLSA) (LSE: TILS) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.

    For further information:

    Tiziana Life Sciences plc
    Kunwar Shailubhai
    02074952379
    info@tizianalifesciences.com

    About the Investor Summit

    The Investor Summit is an exclusive, independent conference dedicated to connecting smallcap and microcap companies with qualified investors. The Q3 Investor Summit will take place virtually, featuring 80+ companies and over 800 investors, consisting of institutional investors, family offices, and private wealth.

    To request complimentary investor registration: please click here: Complimentary Investor Registration

    Contact:

    Sasha Murray at sasha@investorsummitgroup.com

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  7. THIS ANNOUNCEMENT IS FOR US ADS HOLDERS ONLY

    NEW YORK, July 08, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that its American Depository Shares ("ADS"), trading under the ticker TLSA, will begin trading ex-dividend on July 09, 2021.

    The non-cash dividend, in the form of an in-specie dividend of one Accustem Sciences Limited ADS (representing 2 ordinary shares in Accustem Sciences Limited) per TLSA ADS, is scheduled to be paid on July 14, 2021.

    Shareholders who purchased TLSA prior to the ex-dividend date are eligible for the non-cash dividend. 

    THIS ANNOUNCEMENT IS FOR US ADS HOLDERS ONLY

    NEW YORK, July 08, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that its American Depository Shares ("ADS"), trading under the ticker TLSA, will begin trading ex-dividend on July 09, 2021.

    The non-cash dividend, in the form of an in-specie dividend of one Accustem Sciences Limited ADS (representing 2 ordinary shares in Accustem Sciences Limited) per TLSA ADS, is scheduled to be paid on July 14, 2021.

    Shareholders who purchased TLSA prior to the ex-dividend date are eligible for the non-cash dividend. 

    Holders of TLSA should also refer to the notice published by JP Morgan, the ADR depositary bank which can be found at https://www.adr.com/drprofile/88875G101

    For further enquiries:

    United Kingdom:
     
    Tiziana Life Sciences plc

    Gabriele Cerrone,

    Chairman and founder
    +44 (0)20 7495 2379
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com
     



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  8. LONDON and NEW YORK, July 02, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that the Forms 20-F and F-6 filed by Accustem Sciences Limited with the SEC have been declared effective, enabling the completion of the in specie distribution and spin out of Accustem Sciences Limited. These documents together can be found at www.accustem.com

    Times and dates for holders of Tiziana ordinary shares (traded on the London Stock Exchange)

    The timetable for the holders of Tiziana ordinary shares (traded on the London Stock Exchange) held in CREST and Certificated…

    LONDON and NEW YORK, July 02, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that the Forms 20-F and F-6 filed by Accustem Sciences Limited with the SEC have been declared effective, enabling the completion of the in specie distribution and spin out of Accustem Sciences Limited. These documents together can be found at www.accustem.com

    Times and dates for holders of Tiziana ordinary shares (traded on the London Stock Exchange)

    The timetable for the holders of Tiziana ordinary shares (traded on the London Stock Exchange) held in CREST and Certificated form is as follows:

    Demerger Record Time: 7:00 a.m. on 30 October 2020
      
    Ex-entitlement date for Accustem Shares: 2 November 2020
      
    CREST accounts credited with Accustem Shares:8 July 2021*
      
    Certificates for Accustem Shares for those shareholders

    holding their Tiziana Life Sciences plc in certificated form:
    by 18 July 2021
      
    * replacing allocation placeholders currently showing

    Times and dates for holders of Tiziana ADSs (traded on the US Nasdaq Market)

    The timetable for the holders of Tiziana ADSs (traded on the Nasdaq market) are subject to different corporate action timings and holders of the ADRs should also refer to the notice published today by JP Morgan, the ADR depositary bank which can be found at https://www.adr.com/drprofile/88875G101

    Announcement Tiziana CUSIP: 88875G101

    Corporate Action Type:Spin Off with DR Distribution
      
    Spin Off Issuer Name:Accustem Sciences Limited
      
    Spin Off DR CUSIP: 00442Y101
      
    DR Distribution Rate:1 new Accustem DR(s) issued for every 1 existing Tiziana DR held on DR Record Date
      
    Tax Withholding Rate: n/a
      
    DR Record Date:November 6, 2020
      
    DR Payment Date:July 14, 2021
      
    DR Issuance and Cancellation Books close Date: October 28, 2020
      
    DR Issuance and Cancellation Books reopen Date: July 19, 2021
      
    Fees: Issuance fee: $nil per DR issued

    The Issuer has announced a Spin Off Distribution in the local market. Existing Tiziana DRs will continue to be valid and will not have to be exchanged for new DRs.

    For further enquiries:

    United Kingdom:
     
    Tiziana Life Sciences plc

    Gabriele Cerrone,

    Chairman and founder
    +44 (0)20 7495 2379
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com
     


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  9. NEW YORK and LONDON, June 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces an interview with the Chairman of its' Scientific Advisory Board and Professor of Neurology at Harvard Medical School, Dr Howard Weiner is to air on Bloomberg Markets with Matt Miller and Amanda Lang today at 1.50pm ET/6.50pm BST.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed…

    NEW YORK and LONDON, June 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces an interview with the Chairman of its' Scientific Advisory Board and Professor of Neurology at Harvard Medical School, Dr Howard Weiner is to air on Bloomberg Markets with Matt Miller and Amanda Lang today at 1.50pm ET/6.50pm BST.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohn's Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com



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  10. LONDON, June 25, 2021 (GLOBE NEWSWIRE) -- At the Annual General Meeting of the Company held at 10.00 a.m. on 25 June 2021, all of the resolutions were duly passed.

    The results of the proxy voting will be available shortly on the Company's website, https://ir.tizianalifesciences.com/shareholder-services/annual-general-meeting.

    The Company also confirms that it has re-activated its strategic plan to redomicile to Bermuda; shareholders will receive further information in due course.

    The person who arranged for the release of this announcement was Keeren Shah, Chief Financial Officer.

    THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 596/2014

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION,

    LONDON, June 25, 2021 (GLOBE NEWSWIRE) -- At the Annual General Meeting of the Company held at 10.00 a.m. on 25 June 2021, all of the resolutions were duly passed.

    The results of the proxy voting will be available shortly on the Company's website, https://ir.tizianalifesciences.com/shareholder-services/annual-general-meeting.

    The Company also confirms that it has re-activated its strategic plan to redomicile to Bermuda; shareholders will receive further information in due course.

    The person who arranged for the release of this announcement was Keeren Shah, Chief Financial Officer.

    THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 596/2014

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION

    About Tiziana Life Sciences



    Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.     

    For further enquiries:

    United Kingdom: 
     
    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379


    United States:


    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com
     


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  11. NEW YORK and LONDON, June 23, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, announces that it has signed an agreement with FHI Clinical, a global clinical contract research organization (CRO), to conduct a Phase 2 Proof-of-concept study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe coronavirus disease 2019 (COVID-19) and pulmonary inflammation.

    A subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases (https://www.fhiclinical.com

    NEW YORK and LONDON, June 23, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, announces that it has signed an agreement with FHI Clinical, a global clinical contract research organization (CRO), to conduct a Phase 2 Proof-of-concept study in Brazil to evaluate the safety, tolerability and efficacy of intranasal Foralumab in hospitalized patients with severe coronavirus disease 2019 (COVID-19) and pulmonary inflammation.

    A subsidiary of FHI 360, FHI Clinical specializes in the clinical development of drugs for infectious diseases (https://www.fhiclinical.com). The company's involvement with COVID-19 includes Phase 1 to Phase 3 clinical trials for vaccines and therapeutics, as well as observational studies to collect data about the characteristics and course of infection. With experience conducting related studies across 16 countries and 43 states in the United States, FHI Clinical has a large network of clinical sites throughout the world to expedite COVID-19 trials.

    In this clinical trial, Foralumab will be delivered intranasally through a metered-dose nasal atomization device. Nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated. Several studies have suggested that there is dysregulation in the immune system of patients with COVID-19.

    This randomized, placebo-controlled, double-blind, proof-of-concept study is designed to expand on the preliminary findings of safety, tolerability and efficacy of intranasal administration of Foralumab observed in mild to moderate non-hospitalized COVID-19 patients (https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-positive-data-nasal-administration). Thus, this study will examine attenuation of pulmonary pathology in hospitalized patients with severe COVID-19. Up to seven sites in Brazil will be engaged to conduct this study. Eighty hospitalized patients with severe COVID-19 and evidence of pulmonary involvement on a computed tomography (CT) scan at screening will be enrolled. Patients will be randomized 1:1 to receive intranasal Foralumab 100 µg. Additionally, the study will also evaluate the effect of Foralumab on resolution of symptoms by chest CT, inflammatory biomarkers, T-cell subpopulations, safety and mucosal inflammatory response following 14 days of intranasal administration.

    "Our experience is uniquely suited to the needs of this Phase 2 study as we are able to pull from past outbreak experience, including rapid study start-up in research-naïve areas to leveraging existing global research networks and contributing to local health systems," said Ted FitzGerald, FHI Clinical President and CEO. "We excel at addressing the complex aspects of infectious disease trials that require thorough planning and contingency planning."

    "We are pleased to move forward with FHI Clinical on our next COVID-19 trial. After a successful proof-of-mechanism trial in mild to moderate COVID-19 outpatients with intranasal Foralumab earlier this year, the next step is to test it in more severe hospitalized patients with pulmonary inflammation," said Dr. Neil Graham, Chief Medical Officer at Tiziana Life Sciences.

    The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.



    About Tiziana Life Sciences

    Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:        

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379
      
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com
     


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  12. NEW YORK and LONDON, June 21, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, is pleased to announce the appointment of Dr. Kevin Schutz, PharmD, as Vice-President of Regulatory Affairs. Dr. Schutz will lead regulatory interactions related to clinical studies in the United States, Europe and Asian countries.

    Dr. Schutz has over 19 years of pharmaceutical industry experience including 14 years of Regulatory Affairs experience. He has focused on disease indications with high unmet medical needs, in Neurology (including multiple sclerosis), Pulmonology (including infectious disease), and other…

    NEW YORK and LONDON, June 21, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases, is pleased to announce the appointment of Dr. Kevin Schutz, PharmD, as Vice-President of Regulatory Affairs. Dr. Schutz will lead regulatory interactions related to clinical studies in the United States, Europe and Asian countries.

    Dr. Schutz has over 19 years of pharmaceutical industry experience including 14 years of Regulatory Affairs experience. He has focused on disease indications with high unmet medical needs, in Neurology (including multiple sclerosis), Pulmonology (including infectious disease), and other potential disease indications, which the Company is currently developing products for or is planning to pursue. Specifically, Foralumab (an intranasally delivered, next generation, fully human anti-CD3 monoclonal antibody) for Secondary Progressive Multiple Sclerosis (SPMS) and COVID-19 with Pulmonary Inflammation as lead indications.

    "Dr. Schutz brings extensive hands-on experience working with regulatory agencies including the FDA (USA), EMA (Europe), and PMDA (Japan), among others. His background will greatly strengthen Tiziana's global development capabilities in regions where the Company is actively pursuing clinical development. We are pleased to have him on our team to lead this important role in global development of our pipeline," commented Dr. Neil Graham, Chief Medical Officer of Tiziana Life Sciences.

    "I am excited to join the Tiziana team to further the development of products which aim to help patients manage diseases with an unmet medical need. Tiziana's lead pipeline candidate, Foralumab, is promising with multiple potential indications in multiple sclerosis and pulmonary diseases and I look forward to contributing to its development," said Dr. Schutz.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries: 
      
    United Kingdom: 
      
    Tiziana Life Sciences plc 
      
    Gabriele Cerrone, Chairman and founder+44 (0)20 7495 2379
      
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    dave@redchip.com




    407-491-4498


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  13. NEW YORK and LONDON, June 17, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases announces that it has submitted a grant to the United Kingdom COVID Therapeutics Advisory Panel (UK-CTAP) to support further clinical development of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, as an innovative ‘Take Home' approach for treatment of non-hospitalized patients with COVID-19. This is in response to a call from the UK government for proposals to study therapies that can be delivered at home and avoid hospitalization of patients.

    Nasal administration of Foralumab is a highly…

    NEW YORK and LONDON, June 17, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, neurology, inflammation and infectious diseases announces that it has submitted a grant to the United Kingdom COVID Therapeutics Advisory Panel (UK-CTAP) to support further clinical development of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, as an innovative ‘Take Home' approach for treatment of non-hospitalized patients with COVID-19. This is in response to a call from the UK government for proposals to study therapies that can be delivered at home and avoid hospitalization of patients.

    Nasal administration of Foralumab is a highly innovative approach to treat patients with autoimmune diseases where the immune system may be dysregulated. Several studies have suggested that there is dysregulation in the immune system of patients with Covid-19 disease. Previously, we announced the successful completion of a clinical study with nasally administered Foralumab in patients with COVID-19 in Brazil. Results from this study demonstrated that the treatment induced immunomodulatory effects capable of providing clinical benefit to Covid-19 patients. Importantly, the direct delivery of Foralumab using a nasal spray ‘Take Home' device to the nasal passage and respiratory tract rapidly suppressed lung inflammation, as evident from CT scans and reduced systemic markers of inflammation including interleukin-6 and C-reactive protein (https://www.tizianalifesciences.com/news-item?s=2021-02-02-tiziana-reports-positive-data-from-the-clinical-study-of-nasal-administration-with-foralumab-its-proprietary-fully-human-anti-cd3-monoclonal-antibody-in-covid-19-patients-in-brazil).These clinical results warrant further clinical development of nasally administered Foralumab in patients with Covid-19.

    Separately, Tiziana Life Sciences is also completing processes to initiate another clinical trial in COVID-19 hospitalized patients in Brazil. The objective of this study is to evaluate whether nasally administered Foralumab could be useful for hospitalized patients with severe inflammation. Since, nasal administration with Foralumab is an immunomodulatory approach, it is possible that this ‘Take Home' treatment approach could be useful for treatment of other COVID-19 variants, including the variants identified in South Africa, Brazil, the UK and the Delta variant in India.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib (a CDK inhibitor being developed in oncology), the Company is also developing Foralumab in COVID-19, multiple sclerosis, and Crohns Disease. Foralumab is the only second generation fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammatory pulmonary diseases.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries: 
      
    United Kingdom: 
      
    Tiziana Life Sciences plc 
      
    Gabriele Cerrone, Chairman and founder+44 (0)20 7495 2379
      
    United States: 
    Investors: 
    Dave Gentry, CEO 
    RedChip Companies Inc.407-491-4498
    dave@redchip.com  


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  14. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION.

    NEW YORK and LONDON, June 02, 2021 (GLOBE NEWSWIRE) -- The Company announces that a letter to Shareholders has been posted advising that the Notice of Annual General Meeting has been made available on the Company's website: https://ir.tizianalifesciences.com/shareholder-services/annual-general-meeting

    The AGM is to be held on 25 June 2021 at 10.00 am BST.

    As we expect restrictions on personal movement to still be in place due to Covid-19, we are utilising…

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION.

    NEW YORK and LONDON, June 02, 2021 (GLOBE NEWSWIRE) -- The Company announces that a letter to Shareholders has been posted advising that the Notice of Annual General Meeting has been made available on the Company's website: https://ir.tizianalifesciences.com/shareholder-services/annual-general-meeting

    The AGM is to be held on 25 June 2021 at 10.00 am BST.

    As we expect restrictions on personal movement to still be in place due to Covid-19, we are utilising provisions in our articles of association to facilitate the holding of the meeting on an electronic platform. Accordingly, this year's AGM will be an electronic meeting only. All voting at the resolutions at the AGM will be conducted on a poll which means that you should submit your proxy (by post, email or online voting) as soon as possible. We ask that all question which shareholders wish to raise be submitted to info@tizianalifesciences.com in advance.

    The platform that we will be using will allow shareholders the option to submit a separate poll card at the electronic meeting but, to ease administration, we request that proxies be lodged in advance wherever possible.

    Full details of the operation and arrangements for the AGM are set out in the Notice of AGM.

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com

     



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  15. NEW YORK and LONDON, May 26, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, today provided an update on further analysis of lymphocyte subsets from blood samples from a Phase 1 study with nasally administered Foralumab in healthy volunteers. Results exhibiting statistically significant immunomodulatory effects on CD8 cytotoxic T-lymphocytes and other inflammatory biomarkers were observed. This Phase 1 trial, conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind, placebo-controlled, dose-ranging study with nasally administered…

    NEW YORK and LONDON, May 26, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, today provided an update on further analysis of lymphocyte subsets from blood samples from a Phase 1 study with nasally administered Foralumab in healthy volunteers. Results exhibiting statistically significant immunomodulatory effects on CD8 cytotoxic T-lymphocytes and other inflammatory biomarkers were observed. This Phase 1 trial, conducted at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA, was a single-site, double-blind, placebo-controlled, dose-ranging study with nasally administered Foralumab at 10, 50 and 250 mcg per day, consecutively for 5 days in healthy volunteers. The treatment was well-tolerated at all doses and there were no apparent symptoms of severe toxicity. Importantly, the treatment showed significant positive effects at 50 mcg/day dose (compared to other dose and placebo groups) on T-cell subsets and inflammatory biomarkers. These data support other clinical and pre-clinical studies showing that this route of administration is capable of inducing site-targeted immunomodulation and anti-inflammatory effects. Furthermore these pharmacodynamic data point to a clinical dose range that Tiziana intends to test in further clinical development among MS patients.

    Highlights of clinical and immunologic data

    • Nasally administered Foralumab was well tolerated and there were no apparent symptoms of severe toxicity or cytokine release syndrome.
    • Systemic levels of Foralumab were below the lower quantitation limit of 8 ng/mL suggesting that nasally administered Foralumab appears to exert its effects via nasal epithelium utilizing local and lymphatic immune systems directly.
    • Most prominent effects among cytotoxic T-cell subsets were observed in the 50mcg group compared to 10mcg, 250mcg and placebo groups.
    • The observed effects in the 50mcg dose group were the following:
      1. Statistically significant reductions from baseline in CD8_Tem cytotoxic T-cell subset through 14 days and CD8_TEMRA, CD8_GranzymeB, CD8_Perforin subsets through 21 days
      2. Statistically significant increase from baseline in CD8_naive subset through day 21
      3. Statistically significant stimulation in production of anti-inflammatory cytokine IL-10 along with suppressed production of pro-inflammatory cytokine IFN-γ, suggested a positive trend for immunomodulation and anti-inflammatory effect.

    These observed clinical responses on biomarkers, indicative of immunomodulation and anti-inflammatory, are consistent with the positive clinical data observed with nasally administered Foralumab in COVID-19 patients in Brazil. Results from this clinical study demonstrated that nasally administered Foralumab at 100 mcg/day for 10 consecutive days was not only well-tolerated but it also showed significant reduction of lung inflammation along with statistically reduced levels of interleukin-6 (IL-6) and C-reactive protein (CRP), in the blood samples taken from patients (https://www.tizianalifesciences.com/news-item?s=2021-02-02-tiziana-reports-positive-data-from-the-clinical-study-of-nasal-administration-with-foralumab-its-proprietary-fully-human-anti-cd3-monoclonal-antibody-in-covid-19-patients-in-brazil).

    "Nasal administration of Foralumab is a unique approach to treat patients with neurodegenerative diseases such as progressive MS, amyotrophic lateral sclerosis (ALS) and Alzheimer's Disease (AD). This study demonstrates for the first-time that nasally administered Foralumab, at the identified optimal dose of 50 mcg/day, induces immunomodulatory effects capable of providing clinical benefit to treated subjects. These data along with results from our recently completed trial in COVID-19 patients in Brazil suggest a dose-range of 50 mcg-150 mcg could be used for future clinical development of nasally administered Foralumab. This is a major accomplishment providing the scientific rationale to move forward with further clinical development of nasally administered Foralumab in patients with neurodegenerative diseases," commented Dr. Howard L. Weiner, Chair of the Scientific Advisory Board of Tiziana Life Sciences and Professor of Neurology at Harvard Medical School. He added that "both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying immunomodulation. Our immediate focus is on developing Foralumab for treatment of progressive MS."

    "The demonstration of the positive immunomodulatory effects providing a recommended dose-range is important to move forward with further studies in the progressive MS population," stated Dr. Tanuja Chitnis, the study PI at the Brigham and Women's Hospital.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    Preclinical studies on nasal and oral administration with Anti-CD3 mAbs

    Preclinical and clinical studies have shown that mucosal induction of Tregs by oral or nasal administration of anti-CD3 mAbs is an innovative approach to treat autoimmune and anti-inflammatory diseases (Kuhn and Weiner 2016). Nasally administered anti-CD3 mAbs were shown to ameliorate disease in an animal model of multiple sclerosis by inducing IL-10+LAP+ (latency-associated peptide) T cells, demonstrating nasal anti-CD3 mAbs as a new approach to treat progressive forms of multiple sclerosis and other types of chronic CNS inflammation. Additionally, nasally administered anti-CD3 mAbs suppressed lupus in lupus-prone mice (BWF1) by inducing IL-10 and TGF-β dependent mechanisms associated with a suppression of IL-17 and IL-21 pro-inflammatory cytokines.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as multiple sclerosis, crohn's disease, COVID-19, type-1 diabetes (T1D), ulcerative colitis, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:        

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379
      
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com
     


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    • The first patient with SPMS was dosed on May 24, 2021 with nasally administered Foralumab. The treatment regimen will continue for six months to examine long-term safety, tolerability and clinical responses.
    • Previous clinical studies in healthy volunteers and COVID-19 patients showed that nasally administered Foralumab is well-tolerated with no apparent severe adverse events (SAEs) when dosed for up to 10 consecutive days. Results from these studies showed strong anti-inflammatory effects of the treatment regimen.

    NEW YORK and LONDON, May 25, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers…

    • The first patient with SPMS was dosed on May 24, 2021 with nasally administered Foralumab. The treatment regimen will continue for six months to examine long-term safety, tolerability and clinical responses.
    • Previous clinical studies in healthy volunteers and COVID-19 patients showed that nasally administered Foralumab is well-tolerated with no apparent severe adverse events (SAEs) when dosed for up to 10 consecutive days. Results from these studies showed strong anti-inflammatory effects of the treatment regimen.

    NEW YORK and LONDON, May 25, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to announce that the first patient with secondary progressive multiple sclerosis (SPMS) was dosed with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, at the Brigham and Women's Hospital (BWH), Harvard Medical School, Boston, MA. Nasal Foralumab 50 mcg (25 mcg/nostril) will be administered in 3-week cycles, with 3 times/week dosing for the first 2 weeks followed by 1 week of rest period. This first-ever clinical study in SPMS patients, under an Individual Patient Expanded Access IND, will continue for six months to evaluate routine safety, tolerability, and neurological behaviors. The study will also examine microglial activation, by positron emission tomography (PET), immunological and neurodegenerative markers to assess clinical responses following the treatment regimen.

    Previously, Tiziana completed a Phase 1 trial of a single-site, double-blind, placebo-controlled, multiple ascending dose (MAD) once a day dosing for 5 consecutive days with nasally administered Foralumab in healthy subjects. The treatment was well-tolerated with no drug-related safety issues reported at doses of up to 250 mcg. (https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers-of-immunomodulation-and-anti-inflammation-in-healthy-volunteers)

    Subsequently, Tiziana reported positive data from a clinical study with nasally administered Foralumab in COVID-19 patients in Brazil. Results from this clinical study demonstrated that nasally administered Foralumab at 100 mcg/day for consecutive 10 days was well-tolerated and there were no apparent severe adverse events. The clinical results demonstrated that the treatment provided significant reduction of lung inflammation together with a reduction in interleukin-6 (IL-6) and C-reactive protein (CRP), biomarkers of inflammation, in the blood samples taken from patients (https://www.tizianalifesciences.com/news-item?s=2021-02-02-tiziana-reports-positive-data-from-the-clinical-study-of-nasal-administration-with-foralumab-its-proprietary-fully-human-anti-cd3-monoclonal-antibody-in-covid-19-patients-in-brazil)

    Dr. Howard Weiner, Robert Kroc Professor of Neurology at Harvard Medical School said, "Nasally administered anti-CD3 is an exciting, novel approach that has the ability to provide safe treatment for a form of MS that currently has no effective treatment. We are excited to examine this first-in-class approach to treat patients with SPMS for whom no effective treatment option is currently available."

    Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical School and senior neurologist at the BWH, adds, "Effective and targeted treatments for progressive MS are urgently needed. Nasal Foralumab could revolutionize treatment for this disabling form of disease."   

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T-cell receptor, orally administered Foralumab modulates immune responses of the T-cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.



    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.



    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc      +44 (0)20 7495 2379

    Gabriele Cerrone, Chairman and founder



    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com 



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  16. NEW YORK and LONDON, May 07, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced an interview with CEO and CSO Dr. Kunwar Shailubhai will air on The RedChip Money Report on the Bloomberg Network in the U.S. on Saturday, May 8 at 7 p.m. local time. The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. local time in approximately 73M homes.

    To view the interview segment, please visit: https://youtu.be/_S1mS9thG38

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well…

    NEW YORK and LONDON, May 07, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced an interview with CEO and CSO Dr. Kunwar Shailubhai will air on The RedChip Money Report on the Bloomberg Network in the U.S. on Saturday, May 8 at 7 p.m. local time. The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. local time in approximately 73M homes.

    To view the interview segment, please visit: https://youtu.be/_S1mS9thG38

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc (TLSA) is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com

            

    Source: Tiziana Life Sciences



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    • Objective of this partnership with Takanawa Japan K.K., Pharma Team, is to identify a strategic partner in Japan for further development of Milciclib either alone or in combination with a tyrosine kinase inhibitor (TKI) for treatment of advanced HCC patients in Asian countries where prevalence of HCC is high, and the available therapeutic options are not entirely satisfactory.
    • Milciclib, a broad-spectrum cyclin dependent kinase (pan-CDK) inhibitor, has successfully completed eight phase 1 and phase 2 trials in thymic carcinoma, thymoma and hepatocellular carcinoma (HCC), showing tolerability and positive clinical responses.
    • Clinical data from Phase 2a trial, presented at the American Society of Clinical Oncology 2020, indicated that orally administered
    • Objective of this partnership with Takanawa Japan K.K., Pharma Team, is to identify a strategic partner in Japan for further development of Milciclib either alone or in combination with a tyrosine kinase inhibitor (TKI) for treatment of advanced HCC patients in Asian countries where prevalence of HCC is high, and the available therapeutic options are not entirely satisfactory.
    • Milciclib, a broad-spectrum cyclin dependent kinase (pan-CDK) inhibitor, has successfully completed eight phase 1 and phase 2 trials in thymic carcinoma, thymoma and hepatocellular carcinoma (HCC), showing tolerability and positive clinical responses.
    • Clinical data from Phase 2a trial, presented at the American Society of Clinical Oncology 2020, indicated that orally administered Milciclib in Sorafenib-resistant patients was well-tolerated, and it produced positive clinical responses.
    • Tiziana was recently awarded a patent to use Milciclib in combination with a TKI or other drugs for treatment of HCC and other cancers.

    NEW YORK and LONDON, May 05, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces that it has executed an agreement with Takanawa Japan K.K, Pharma Team, (Takanawa) for a strategic business development plan to Identify a clinical partner in Japan and other Asian countries for further clinical development of Milciclib for treatment in advanced hepatocellular carcinoma (HCC) patients. HCC is the most common type of liver cancer and affects approximately 200,000 people per year.

    Previously, Tiziana successfully completed a Phase 2 clinical trial with orally administered Milciclib in sorafenib-resistant or intolerant HCC patients. The clinical data, presented at the American Society of Clinical Oncology (ASCO)1, demonstrated that the treatment was well-tolerated and produced clinical activity. Recently, a patent covering the use of Milciclib in combination with a tyrosine kinase inhibitor (TKI) or other drugs was granted2. The granted claims provide complete freedom to further develop a combination of Milciclib with an approved TKI for treatment of patients with advanced HCC or other cancers. Because the prevalence of HCC in Asian countries is large and there are no satisfactory therapeutic options for treatment of advanced HCC in Asian countries, the strategic initiative with Takanawa is particularly important to further develop Milciclib for the treatment of advanced HCC patients.

    "We are pleased and excited to work with Takanawa, a firm with a distinguished history of business development activities in the Japanese pharmaceutical industry, to identify an appropriate partner in Japan for further clinical development of Milciclib. We believe the positive clinical activity in advanced HCC and other cancers warrant immediate further development in Japan and other Asian countries where the prevalence of this cancer is relatively high, and the current available therapies are not entirely satisfactory" said Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences.

    "We are honored to get the opportunity to identify a strategic partner for Milciclib for the treatment of advanced hepatocellular carcinoma (HCC) patients. Tiziana has managed to develop a product that will really have an impact and save lives since HCC affects about 200,000 people in the world and 40,000 people in Japan every year. Therefore, we hope to receive a lot of interest from leading pharmaceutical companies " said Dr. Kaoru Nozu, Executive Representative of the Takanawa Pharma Team.

    The person who arranged for the release of this announcement on behalf of the Company was

    Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    Cited References:

    1. Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.

      First Author: Erica Villa, MD., et al.
    2. US Patent (10,758,541 B2 (Inventor: Shailubhai) Issue Date: September 1, 2020

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (THE "EUWA")) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

    About Milciclib



    Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies.  In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.



    About Tiziana Life Sciences



    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation, and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    About Takanawa

    Takanawa is a global consulting, development and trading company, with a very strong Pharma Team. In that area Takanawa develops its own pharma projects, advises cross border pharma transactions, licensing, and alliances. Takanawa also supports companies entering the Japanese and Asian market as well as Japanese companies to enter overseas markets. Takanawa's seasoned pharma specialists are both high level scientists with research background from USA (Bethesda), NCI and NIH, and from Japan, the Japanese Foundation for Cancer Research, Japan National Institute of Radiological Medicines, Tokyo University and Kyoto University, as well as experienced business people from leading pharma companies like Sanofi, Kyowa Kirin, Yakult and Actavis, with an extensive track record and network. Examples of known oncology products Takanawa specialists have been involved with in their previous positions are oxaliplatin, camptothecin (irinotecan), G-CSF, docetaxel, epirubicin, gemcitabine, vinorelbine and 5-FU. For further information please see www.takanawa.is/pharmaceuticals.

    Forward-Looking Statements



    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom: 
    Tiziana Life Sciences plc

    +44 (0)20 7495 2379
    Gabriele Cerrone,

    Chairman and founder
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com 

     



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  17. NEW YORK and LONDON, April 27, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced its CEO and CSO Dr. Kunwar Shailubhai and the chair of its Scientific Advisory Committee, Dr Howard Weiner, will participate in a fireside chat via a video link on Wednesday, 28 April 2021 at 10:30 a.m. EDT (US and Canada) to provide updates on the Company. Please note that only information which is already in the public domain will be discussed.

    Date:Wednesday, 28 April 2021
    Time:10:30 a.m. – 11:00 a.m. Eastern Daylight Savings Time (US and Canada)
    Webcast:https://www.webcaster4.com/Webcast/Page/2433/41045

    NEW YORK and LONDON, April 27, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced its CEO and CSO Dr. Kunwar Shailubhai and the chair of its Scientific Advisory Committee, Dr Howard Weiner, will participate in a fireside chat via a video link on Wednesday, 28 April 2021 at 10:30 a.m. EDT (US and Canada) to provide updates on the Company. Please note that only information which is already in the public domain will be discussed.

    Date:Wednesday, 28 April 2021
    Time:10:30 a.m. – 11:00 a.m. Eastern Daylight Savings Time (US and Canada)
    Webcast:https://www.webcaster4.com/Webcast/Page/2433/41045

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379



    United States Investors:

    Dave Gentry

    RedChip Companies Inc.





    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com

     



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  18. NEW YORK and LONDON, April 13, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), today announced that its former subsidiary, Accustem Sciences Limited ("Accustem"), intends to file a listing application with the Nasdaq Stock Market shortly after completion of the distribution of shares in Accustem to Tiziana Life Sciences plc shareholders.

    The board of directors of Accustem has resolved that the Nasdaq listing venue is more appropriate to the nature of Accustem's business.

    About Accustem Sciences

    StemPrintER is a multi-gene prognostic assay intended to predict the risk of recurrence of R+/HER2- breast cancer, and Spare, a derivative of StemPrintER, combines StemPrintER with two clinical markers. This gives a…

    NEW YORK and LONDON, April 13, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))), today announced that its former subsidiary, Accustem Sciences Limited ("Accustem"), intends to file a listing application with the Nasdaq Stock Market shortly after completion of the distribution of shares in Accustem to Tiziana Life Sciences plc shareholders.

    The board of directors of Accustem has resolved that the Nasdaq listing venue is more appropriate to the nature of Accustem's business.

    About Accustem Sciences

    StemPrintER is a multi-gene prognostic assay intended to predict the risk of recurrence of R+/HER2- breast cancer, and Spare, a derivative of StemPrintER, combines StemPrintER with two clinical markers. This gives a more refined risk model.

    These assays are intended for the prediction of the risk of recurrence of breast cancer, based on the detection of 20 stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer. Subsequently, StemPrintER has been further validated in an independent retrospective cohort of more than 800 ER+/HER2- postmenopausal patients from the TransATAC trial.

    A poster presented at the American Society of Clinical Oncology (ASCO) Virtual Conference in May 2020, demonstrated the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast cancer patients.

    Endocrine receptor-positive (ER+) breast cancers make up most breast cancer cases, however display significant variability in clinical behaviour, this makes prognosis and therapy response challenging. Although the overall prognosis of patients is good, a significant proportion of these women will experience distant recurrence in the first 10 years post-surgery.

    For patients who also have a negative HER2 status (HER2-) and risk of recurrence, the standard of care is endocrine therapy, with the addition of chemotherapy in patients. However, these parameters are often insufficient to predict risk of recurrence in ER+/HER2- breast cancer patients, and consequently, these patients are either over- or under-treated.

    Accustem anticipates this prognostic test to be used in conjunction with clinical evaluation to identify those patients at increased risk for early and/or late metastasis.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc (TLSA)

    Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379

    U.S. Investor Relations Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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  19. NEW YORK and LONDON, March 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to announce that the U.S. Food and Drug Administration (FDA) has allowed evaluation of nasal administration with Foralumab, a fully human anti-CD3 monoclonal antibody, in a secondary progressive multiple sclerosis (SPMS) patient at the Brigham and Women's Hospital (BWH), Harvard University, Boston, MA. This patient will be treated under an Individual Patient Expanded Access IND. This is the first time a nasally administered antibody will be administered to a patient with SPMS. The treatment is planned…

    NEW YORK and LONDON, March 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, LSE: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory diseases and cancers, is pleased to announce that the U.S. Food and Drug Administration (FDA) has allowed evaluation of nasal administration with Foralumab, a fully human anti-CD3 monoclonal antibody, in a secondary progressive multiple sclerosis (SPMS) patient at the Brigham and Women's Hospital (BWH), Harvard University, Boston, MA. This patient will be treated under an Individual Patient Expanded Access IND. This is the first time a nasally administered antibody will be administered to a patient with SPMS. The treatment is planned to start in the second quarter of 2021, and will continue for six months. Investigators at BWH will follow this patient with detailed routine safety, neurological, imaging and PET studies to evaluate microglial imaging. Modification of immunological and neurodegenerative markers is part of standard investigations that will be conducted at the BWH.

    Previously, Tiziana completed a Phase 1 trial of a single-site, double-blind, placebo-controlled, multiple ascending dose (MAD) once a day dosing for 5 consecutive days with nasally administered Foralumab in healthy subjects. The treatment was well-tolerated with no drug-related safety issues reported at any doses up to 250 mg of the doses.   Nasal foralumab was developed by Professor Howard Weiner at BWH.

    Weiner commented, "Nasal anti-CD3 is an exciting, novel approach that has the ability to provide a safe treatment for a form of MS that has no effective treatment. We are pleased that the FDA has allowed us to treat a patient with SPMS who needs a better treatment option than is currently available."

    Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical School and senior neurologist at the BWH, adds, "New treatments for progressive MS are urgently needed. Nasal Foralumab could revolutionize treatment for this disabling form of disease." 

    The company had previously reported positive data from the Clinical Study of Nasal Administration with Foralumab in COVID-19 patients in Brazil. Nasally administered Foralumab at 100 mg/day for consecutive 10 days treatment was found to be well-tolerated, and there were no apparent severe adverse events. The clinical data suggested that the treatment provided significant reduction of lung inflammation.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc    +44 (0)20 7495 2379

    Gabriele Cerrone,

    Chairman and founder 
     
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    1-800-RED-CHIP (733-2447)

    or

    407-491-4498

    dave@redchip.com


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  20. NEW YORK and LONDON, March 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences. (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, is pleased to confirm that, in order to finalise the distribution of shares in Accustem Sciences Limited ("Accustem") to the holders of Tiziana shares in the US via its ADS program, it has recently filed a Form 20-F with the Securities Exchange Commission in the USA (the "SEC"). The Form 20-F (which gives full information about the business of Accustem), can be found at https://sec.report/CIK/0001850767.

    Once the SEC has approved the Form 20-F (or it becomes effective), the final aspect of the distribution will be complete…

    NEW YORK and LONDON, March 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences. (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, is pleased to confirm that, in order to finalise the distribution of shares in Accustem Sciences Limited ("Accustem") to the holders of Tiziana shares in the US via its ADS program, it has recently filed a Form 20-F with the Securities Exchange Commission in the USA (the "SEC"). The Form 20-F (which gives full information about the business of Accustem), can be found at https://sec.report/CIK/0001850767.

    Once the SEC has approved the Form 20-F (or it becomes effective), the final aspect of the distribution will be complete and Accustem will be an entirely separate entity and will move forward with plans to secure its own listing.

    In the meantime, Tiziana shareholders are directed to the Accustem website at http://www.accustem.com/, where all further developments and news will be published.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc (TLSA)

    Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379

    U.S. Investor Relations Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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    • Since the anti-inflammatory effect of the nasally administered Foralumab is through the modulation of the immune system and not by directly targeting Covid-19, this therapeutic approach could be useful for newly identified Covid-19 variants in the UK, South Africa and Brazil.
    • Foralumab is the first monoclonal antibody that can be dosed nasally or orally, due to its ability to effect systemic immunity via the epithelial lining of the nose, respiratory tract and gut.
    • The direct rapid delivery of Foralumab to the nasal passage and respiratory tract was shown in a previous study of mild to moderate Covid-19 patients to suppress lung inflammation, as evident from CT scans and reduced systemic markers of inflammation including interleukin-6 and C-reactive
    • Since the anti-inflammatory effect of the nasally administered Foralumab is through the modulation of the immune system and not by directly targeting Covid-19, this therapeutic approach could be useful for newly identified Covid-19 variants in the UK, South Africa and Brazil.
    • Foralumab is the first monoclonal antibody that can be dosed nasally or orally, due to its ability to effect systemic immunity via the epithelial lining of the nose, respiratory tract and gut.
    • The direct rapid delivery of Foralumab to the nasal passage and respiratory tract was shown in a previous study of mild to moderate Covid-19 patients to suppress lung inflammation, as evident from CT scans and reduced systemic markers of inflammation including interleukin-6 and C-reactive protein.

    NEW YORK and LONDON, March 30, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reports that it plans further development of Foralumab, its proprietary anti-CD3 human monoclonal antibody in Covid-19. A recent clinical study in mild to moderate Covid-19 patients showed evidence that the nasally administered anti-CD3 monoclonal antibody reduced pulmonary and systemic inflammation and it was well tolerated. That study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil. Tiziana now plans a phase 2 randomized, placebo-controlled trial in Brazil for moderate to severe hospitalized Covid-19 patients to test the drug in a more compromised group of patients. All patients will receive standard of care background therapy.

    Recent studies suggest that the pathogenesis of pulmonary inflammation in Covid-19 includes an abnormal host response or overreaction of the immune system in patients. Therefore, nasal treatment with Foralumab, a fully human anti-CD3 mAb, to modulate the immune system and to stimulate Tregs is a scientifically logical approach for the treatment of Covid-19. Foralumab is also the only monoclonal antibody that can be dosed nasally or orally due to its ability to effect systemic immunity via the epithelial lining of the nose, respiratory tract and gut.

    "I am pleased to see this novel dosing concept for anti-CD3 advance to a phase 2 clinical trial. These types of human trials are important to validate the successful studies we conducted in animal models of several inflammatory diseases," said Professor Howard Weiner, the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center, and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital.

    This study is expected to serve as a further proof of concept for Foralumab's novel method of nasal delivery, as well as its safety and efficacy as a potent, systemic anti-inflammatory therapeutic in more severe Covid-19 patients.

    Covid-19 enters through the nasal and respiratory passage; accordingly, the proprietary nasal formulation and nasal delivery of Foralumab to modulate immunity are expected to delay progression of the disease and to provide immediate relief to Covid-19 patients.

    Dr Neil Graham, Chief Medical Officer at Tiziana Life Sciences, commented, "We are excited about this next important step in our goal to validate our drug candidate and our novel delivery system as a promising and innovative approach to immunomodulatory therapy for Covid-19 and other mutant variants. By focusing on moderating the inflammatory consequences of the SARS CoV2 virus, we hope to have a therapy that has efficacy irrespective of local viral variants."

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.



    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.



    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com



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  21. NEW YORK and LONDON, March 29, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences. (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces that the Chairman and founder, Gabriele Cerrone, will give an interview on Bloomberg Television on Monday, 29 March 2021 at 1.20 p.m. US Eastern Standard Time (6.20 p.m. London) as part of the Bloomberg Surveillance Show.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab…

    NEW YORK and LONDON, March 29, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences. (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces that the Chairman and founder, Gabriele Cerrone, will give an interview on Bloomberg Television on Monday, 29 March 2021 at 1.20 p.m. US Eastern Standard Time (6.20 p.m. London) as part of the Bloomberg Surveillance Show.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as non-alcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc (TLSA)

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    U.S. Investor Relations Contact:

    RedChip Companies, Inc.

    Dave Gentry1-800 RED-CHIP (733-2447)

    Or 407-491-4498

    Dave@redchip.com

    407-491-4498

    dave@redchip.com



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  22. NEW YORK and LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that an interview with its CEO, Dr Kunwar Shailubhai, will air on The RedChip Money Report on Bloomberg Television on Saturday, February 27, 2021 at 7 p.m. local time across the United States and on the Bloomberg Network in Europe on Sunday, February 28, 2021 at 6 p.m. local time. The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. local time in 73M homes and on the Bloomberg Network in Europe in 100M homes at 6 p.m. local time on Sundays.

    In the exclusive interview, Dr Shailubhai…

    NEW YORK and LONDON, Feb. 26, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences (NASDAQ:TLSA, LSE: TILS))), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that an interview with its CEO, Dr Kunwar Shailubhai, will air on The RedChip Money Report on Bloomberg Television on Saturday, February 27, 2021 at 7 p.m. local time across the United States and on the Bloomberg Network in Europe on Sunday, February 28, 2021 at 6 p.m. local time. The RedChip Money Report airs on Bloomberg Television U.S. on Saturdays at 7 p.m. local time in 73M homes and on the Bloomberg Network in Europe in 100M homes at 6 p.m. local time on Sundays.

    In the exclusive interview, Dr Shailubhai discusses topline data from Tiziana's COVID-19 trial, its multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases.

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc (TLSA)

    Gabriele Cerrone, Chairman and founder                                 +44 (0)20 7495 2379

    U.S. Investor Relations Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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  23. SINGAPORE, Feb. 18, 2021 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the appointment of Neil Graham, MBBS, MD, MPH as an independent director. Dr Graham, an expert in immunology and inflammation, has more than 30 years' experience in global drug development and commercialisation, traversing early and late-stage clinical trials in dermatology, allergy, rheumatology, virology, and pulmonology. Dr Graham is currently Chief Medical Officer of Tiziana Life Sciences plc (NASDAQ:TLSA, AIM:TILS))) and a director of Pharmaxis Ltd.

    Dr Graham was previously the VP of Strategic Program Direction…

    SINGAPORE, Feb. 18, 2021 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the appointment of Neil Graham, MBBS, MD, MPH as an independent director. Dr Graham, an expert in immunology and inflammation, has more than 30 years' experience in global drug development and commercialisation, traversing early and late-stage clinical trials in dermatology, allergy, rheumatology, virology, and pulmonology. Dr Graham is currently Chief Medical Officer of Tiziana Life Sciences plc (NASDAQ:TLSA, AIM:TILS))) and a director of Pharmaxis Ltd.

    Dr Graham was previously the VP of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc., from 2010 to 2020, where he was appointed Global Strategic Program leader for the dupilumab development program from phase 1 through to its commercial launch. Dr Graham also led the product development for KEVZARA (sarilumab), an IL-6R antibody for rheumatoid arthritis, and REGN3500, an anti-IL33 antibody for asthma and COPD.

    Jun Wu, representative of Alnair Investment, after serving for eight years, has resigned from the board with effect from February 18, 2021, as the fund is reaching the end of its investment cycle. Kelvin Sun, independent director based in Taiwan, will also be stepping down with effect from February 18, 2021, following the company's delisting from the Taipei Exchange and shift to the Nasdaq Global Market as the company's sole listing.

    Andrew Howden, Chairman, ASLAN Pharmaceuticals, said, "We are delighted to welcome Dr Graham to ASLAN's board of directors. His global expertise in immunology and inflammation, and strategic guidance will be of great value to our team as we approach important milestones in the clinical development of ASLAN004 and ASLAN003 this year. On behalf of the board, I would like to extend our appreciation to Jun Wu and Kelvin Sun for their support and guidance to the management team during ASLAN's growth."

    Media and IR contacts

    Emma Thompson

    Spurwing Communications

    Tel: +65 6751 2021

    Email: ASLAN@spurwingcomms.com



    Robert Uhl

    Westwicke Partners

    Tel: +1 858 356 5932

    Email: robert.uhl@westwicke.com

    About ASLAN Pharmaceuticals

    ASLAN Pharmaceuticals (NASDAQ:ASLN) is a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients. Led by a senior management team with extensive experience in global development and commercialisation, ASLAN has a clinical portfolio comprised of a first-in-class monoclonal therapy, ASLAN004, that is being developed in atopic dermatitis and other immunology indications, and ASLAN003, which it plans to develop for autoimmune disease. For additional information please visit www.aslanpharma.com.



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  24. NEW YORK and LONDON, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that it is presenting at the BIO CEO & Investor Digital Conference, 16-18th February 2021.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with conference attendees. With the release of our topline data from our COVID-19 trial, multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases in the longer-term, we are well positioned to achieve…

    NEW YORK and LONDON, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that it is presenting at the BIO CEO & Investor Digital Conference, 16-18th February 2021.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with conference attendees. With the release of our topline data from our COVID-19 trial, multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases in the longer-term, we are well positioned to achieve a series of important milestones in the months and quarters ahead."

    Tiziana Life Sciences presentation will be accessible on demand during the virtual event for all registered attendees.

    Please visit http://www.tizianalifesciences.com/about-us/ or www.TLSAinfo.com for more information and to view the latest investor presentation.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

    U.S. Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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  25. NEW YORK and LONDON, Feb. 05, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announces the appointment of Dr. Thomas Adams, Ph.D. as an executive director.

    Dr. Adams will assume the position of Head of Drug Development with immediate effect and his executive role will be to manage and oversee all matters relating to the Company's pre-clinical and clinical drug development programs and associated intellectual property.

    Dr. Thomas H. Adams (age: 78)

    Dr. Adams holds a Ph.D. in Biochemistry from the University of California, Riverside. The Board believes that Dr. Adams' executive…

    NEW YORK and LONDON, Feb. 05, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announces the appointment of Dr. Thomas Adams, Ph.D. as an executive director.

    Dr. Adams will assume the position of Head of Drug Development with immediate effect and his executive role will be to manage and oversee all matters relating to the Company's pre-clinical and clinical drug development programs and associated intellectual property.

    Dr. Thomas H. Adams (age: 78)

    Dr. Adams holds a Ph.D. in Biochemistry from the University of California, Riverside. The Board believes that Dr. Adams' executive leadership and the extensive healthcare expertise he has developed makes Dr. Adams ideally qualified to serve as an additional director of the Company. 

    Dr. Adams, has been a director of Cardiff Oncology, Inc (NASDAQ:CRDF) ("Cardiff") since June 2018, serving in the roles of Chief Executive Officer from June 2018 to May 2020, as chairman of the board from April 2009 to December 2020 and as Executive Chairman from May through December 2020.

    At Cardiff, Dr. Adams led the development and repurposing of onvansertib, a first-in-class, third-generation Polo-like Kinase 1 (PLK1) inhibitor, in combination with standard-of-care chemotherapy and targeted therapeutics, for the potential treatment of KRAS-mutated metastatic colorectal cancer (mCRC), metastatic castration-resistant prostate cancer and relapsed or refractory acute myeloid leukemia.

    He is currently a Director at Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), where he has served since 2014. Previously, Dr. Adams served as Chairman of Clearbridge BioPhotonics, Inc., an imaging solutions company, from 2013 to 2019, and as Director of Synergy Pharmaceuticals, Inc. from 2009 to 2019.

    He served in several leadership roles at IRIS International, including Director, Head of Personalized Medicine and Chief Technology Officer, from 2005 until the company's acquisition by Danaher Corporation in 2012.

    From 1998 to 2006, Dr. Adams was Chairman and Chief Executive Officer of Leucadia Technologies, a privately held biotechnology company which was acquired by IRIS International, Inc. in 2006.

    Dr. Adams founded Genta, Inc. in 1989 and served as its Chief Executive Officer until 1997. He also founded Gen-Probe, Inc. in 1984 and served as Chairman and Chief Executive Officer until its acquisition by Chugai Biopharmaceuticals, Inc. in 1989.

    Dr. Adams stated, "I am excited to join the team at Tiziana to focus on developing Foralumab and Milciclib. These new targeted therapies promise to deliver relief to patients suffering from cancer, inflammatory and infectious disease. My experience in precision medicine utilizing targeted therapies with precision diagnostics should accelerate the delivery of these important therapeutics."

    Gabriele Cerrone, Chairman of Tiziana, said, "We are delighted to welcome Dr. Adams to the Board and consider that his proven track record in the field of cancer could add significant value to the development of the Company's Milciclib and Foralumab oncology programs."

    This announcement contains inside information.

    Pursuant to Listing Rule 9.6.13, in connection with Dr. Adams' appointment, Dr. Adams was Executive Chairman of Synergy Pharmaceuticals Inc. until October 2018. In December 2018 Synergy Pharmaceuticals Inc. (then listed on NASDAQ), filed for Chapter 11 bankruptcy in the USA. The company currently remains in the administration process. There are no other disclosures to make pursuant to Listing Rule 9.6.13, in respect of Dr. Adams' appointment.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

    U.S. Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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  26. NEW YORK and LONDON, Feb. 03, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an interview with Dr. Kunwar Shailubhai, CEO and CSO, is now available.

    In the exclusive interview, Dr. Shailubhai discusses the positive effect of nasally administered Foralumab in COVID-19 mediated pulmonary and systemic inflammation and its potential related to newly identified COVID-19 variants in UK, South Africa, and Brazil. Dr. Shailubhai also comments on the nearly 2x improvement shown in CT scans of the lungs of patients treated with Foralumab as compared to those in the control…

    NEW YORK and LONDON, Feb. 03, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced an interview with Dr. Kunwar Shailubhai, CEO and CSO, is now available.

    In the exclusive interview, Dr. Shailubhai discusses the positive effect of nasally administered Foralumab in COVID-19 mediated pulmonary and systemic inflammation and its potential related to newly identified COVID-19 variants in UK, South Africa, and Brazil. Dr. Shailubhai also comments on the nearly 2x improvement shown in CT scans of the lungs of patients treated with Foralumab as compared to those in the control group.

    COVID-19 enters through the nasal and respiratory passage, accordingly the proprietary nasal formulation and nasal delivery of Foralumab to modulate immunity is expected to delay progression of the disease and to provide immediate relief to COVID-19 patients.

    To watch Dr. Shailubhai's interview now, click here.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc



    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

    U.S. Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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  27. New York, Feb. 02, 2021 (GLOBE NEWSWIRE) -- - Tiziana Life Sciences PLC (NASDAQ:TLSA) (LON:TILS) hails positive results from Brazil coronavirus study of breakthrough nasally-administered antibody treatment click here

    - BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRF) (FRA:NPAU) files patent protection for its newest compound TD-010 to treat anxiolytic-use disorder click here

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    - HempFusion Wellness Inc (TSX:CBD) (FRA:8OO) announces exclusive partnership…

    New York, Feb. 02, 2021 (GLOBE NEWSWIRE) -- - Tiziana Life Sciences PLC (NASDAQ:TLSA) (LON:TILS) hails positive results from Brazil coronavirus study of breakthrough nasally-administered antibody treatment click here

    - BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRF) (FRA:NPAU) files patent protection for its newest compound TD-010 to treat anxiolytic-use disorder click here

    - Heritage Cannabis Holdings Corp (CSE:CANN) (OTCQX:HERTF) (FRA:2UE) files a preliminary prospectus for an upcoming equity financing click here

    - Mirasol Resources Ltd (CVE:MRZ) (OTC:MRZLF) (FRA:M8R) commences new 2,700 metre drill program at Virginia silver project in Argentina click here

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    - Silvercorp Metals Inc (TSX:SVM) (NYSEAMERICAN:SVM) (FRA:S9Y) subsidiary acquires La Yesca silver project in Mexico click here

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    • Since the anti-inflammatory effect of the nasally administered Foralumab is through the modulation of the immune system and not by directly targeting COVID-19, this therapeutic approach might also be useful for newly identified Covid-19 variants in UK, South Africa and Brazil.
    • Foralumab is also the first monoclonal antibody that can be dosed nasally or orally due to its ability to effect systemic immunity via the epithelial lining of the nose, respiratory tract and gut.
    • The direct delivery of Foralumab to the nasal passage and respiratory tract rapidly suppresses lung inflammation, as evident from the CT scans. The treatment also improved the senses of smell and taste in treated patients. The nasal administration of Foralumab can be done at home
    • Since the anti-inflammatory effect of the nasally administered Foralumab is through the modulation of the immune system and not by directly targeting COVID-19, this therapeutic approach might also be useful for newly identified Covid-19 variants in UK, South Africa and Brazil.
    • Foralumab is also the first monoclonal antibody that can be dosed nasally or orally due to its ability to effect systemic immunity via the epithelial lining of the nose, respiratory tract and gut.
    • The direct delivery of Foralumab to the nasal passage and respiratory tract rapidly suppresses lung inflammation, as evident from the CT scans. The treatment also improved the senses of smell and taste in treated patients. The nasal administration of Foralumab can be done at home by patients.
    • The positive effects of the treatment are also supported by the data indicating a trend toward greater reduction in systemic biomarkers of inflammation, such as the levels of Interleukins-6 ("IL-6") and c-reactive protein ("CRP") in blood samples of Foralumab treated patients as compared to those in the control cohort.        

    NEW YORK and LONDON, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reports positive data from the exploratory clinical study in Brazil investigating nasally administered Foralumab, its proprietary anti-CD3 human monoclonal antibody, either alone or in combination with orally administered dexamethasone ("Dexa") in COVID-19 patients. The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), and INTRIALS, a full-service Latin American CRO based in São Paulo, Brazil.

    Recent studies suggest that the pathogenesis of COVID-19 includes an abnormal host response or overreaction of the immune system in patients. It should also be noted that obesity is also one of the risk factors for COVID-19, and data from obese subjects have shown that levels of circulating T regulatory cells ("Tregs") are depleted in obese patients compared with those in lean patients[1]. Consequently, there is a higher state of inflammation and insulin resistance, which results in local production of high levels of inflammatory cytokines, chemokines, and free radicals locally that cause severe damage to the lungs and other organs. Therefore, nasal treatment with Foralumab, a fully human anti-CD3 mAb, to modulate the immune system and to stimulate Tregs is a scientifically logical approach for the treatment of COVID-19. Foralumab is also the only monoclonal antibody that can be dosed nasally or orally due to its ability to effect systemic immunity via the epithelial lining of the nose, respiratory tract and gut. This study served as proof of concept for Foralumab's unique method of delivery as well as its safety and efficacy as a potent systemic anti-inflammatory therapeutic.

    The objectives of the trial were to assess safety of the treatment and to evaluate if progression of the diseases is delayed with nasally administered Foralumab. As this was an exploratory clinical study, it was not powered for statistical analysis. This study enrolled 39 patients randomized in three cohorts: cohort 1, control with no treatment (n=16); cohort 2; nasally administered Foralumab plus 3 days of priming with orally administered 6 mg Dexa (n=12) and cohort 3; nasally administered Foralumab (n=12). The Foralumab treatment regimen was once a day dosing for 10 consecutive days. Many patients had received steroids prior to enrollment in the trial but those patients stopped taking steroids on enrolling in the study. Thus, the cohort 2 included priming with 3 days of orally administered dexa along with 10 days of treatment with nasally administered Foralumab to assess if inclusion of Dexa may affect the action of Foralumab. There were no significant differences between cohort 2 and 3.

    Clinical Data

    Cohort (evaluable patients)Lung CT Scan

    (% Improvement)
    Cytokine IL-6

    (% Reduction)
    C-Reactive Protein

    (% Reduction)
    Control (n=14)433740
    Foralumab + Dexa (n=12)754155
    Foralumab (n=10)806985
    • All treatments were well-tolerated. There were no grade 3 or 4 severe adverse events ("SAEs") in any of the cohorts.
    • The CT scans of the lungs showed the improvement was approximately double that shown in patients treated with Foralumab as compared to those in the control group.
    • Medical records of patients also showed a more rapid recovery in senses of smell and taste in Foralumab treated patients, as compared to those in the control group.
    • Data on pharmacokinetics of nasally administered Foralumab, immunological biomarkers, stimulation of Tregs and anti-drug antibody ("ADA") is expected to be reported in a few weeks.

    COVID-19 enters through the nasal and respiratory passage, accordingly the proprietary nasal formulation and nasal delivery of Foralumab to modulate immunity is expected to delay progression of the disease and to provide immediate relief to COVID-19 patients. Dr. Howard Weiner (the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center, and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital) commented: "Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human infectious diseases with an overreactive immune systems, such as acute respiratory distress syndrome caused by COVID-19, its variants and other viruses causing Middle East Respiratory Syndrome ("MERS") and Severe Acute Respiratory Syndrome ("SARS")".

    Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, and Dr. Kimble Matos, the lead coordinating physician of the study commented: "We are delighted to see that patients treated with nasally administered Foralumab showed a positive trend in the reduction of lung inflammation, and supportive data indicating significant reduction in cytokine IL-6 and C-reactive protein. In addition, there are indications from patients who reported that treatment with Foralumab rapidly improved the smell and taste sensations that are frequently lost with severity of COVID-19 disease".



    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented: "We are delighted with the promising clinical data showing evidence of the positive effect of nasally administered Foralumab in Covid-19 mediated pulmonary and systemic inflammation. This is a first-in-class and scientifically logical approach to modulate the host immune system to fight the inflammatory reaction to SARS-CoV2 (Covid-19 virus). Thus, this approach may be effective against patients infected with the newly identified Covid-19 variants in UK, South Africa and Brazil, but there is no data on this yet. The clinical data demonstrates the safety of nasally administered Foralumab and provides evidence of anti-inflammatory effects which will further support our upcoming Phase 2 clinical study with nasally administered Foralumab in patients with secondary progressive multiple sclerosis.

    Cited Reference

    1. Stephen-Victor E, Das M, Karnam A, et al. Potential of regulatory T-cell-based therapies in the management of severe COVID-19. Eur Respir J 2020; 56: 2002182 [https://doi.org/ 10.1183/13993003.02182-2020].

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    THIS ANNOUNCEMENT INCLUDES INSIDE INFORMATION

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody ("mAb") in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes ("T1D"), inflammatory bowel disease ("IBD"), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor ("IL6R") mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone,

    Chairman and founder
    +44 (0)20 7495 2379


    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
     



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  28. NEW YORK and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announces that it has filed a "universal" shelf registration statement on Form F-3 (File No. 333-252441) (the "Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") in relation to up to US$250,000,000 in market value of its securities.

    The filing of "universal" shelf registration statements of this type, a common practice by NASDAQ-listed companies, enables issuers to have more timely and efficient access to the U.S. capital markets.

    The Registration Statement also contains a preliminary prospectus supplement…

    NEW YORK and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announces that it has filed a "universal" shelf registration statement on Form F-3 (File No. 333-252441) (the "Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") in relation to up to US$250,000,000 in market value of its securities.

    The filing of "universal" shelf registration statements of this type, a common practice by NASDAQ-listed companies, enables issuers to have more timely and efficient access to the U.S. capital markets.

    The Registration Statement also contains a preliminary prospectus supplement relating to an "at-the-market" sales agreement, which the Company expects to enter into with B. Riley Securities, Inc. (the "Agent") on or about the date of this announcement, pursuant to which the Company may sell, from time to time, at its option, up to US$100,000,000 (i.e., up to 40% of those securities registered pursuant to the Registration Statement) in market value of American Depositary Shares representing its ordinary shares through the Agent (the "ATM Program").

    For the avoidance of doubt, the Company has no immediate plans to offer or sell any securities pursuant to the Registration Statement or the ATM Program.

    The Company notes that the Registration Statement has not yet been declared effective by the SEC, and that the specifics of any future offering pursuant to the Registration Statement (including under the ATM Program), such as the prices and terms of the securities offered, will be determined at the time of any such offering and will be described in detail in a prospectus supplement filed by the Company with the SEC in connection with such offering.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, LSE: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Important legal information

    This announcement shall not constitute an offer to sell or the solicitation of an offer to buy any Securities, nor shall there be any sale of any Securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Neither this announcement nor the Registration Statement forms part of an offer of transferable securities to the public in the United Kingdom and no prospectus has been, or is required to be, submitted to the UK Financial Conduct Authority for approval. The filing of the Registration Statement with the SEC does not affect the statutory pre-emption rights of shareholders in the Company.

    The securities registered pursuant to the Registration Statement may not be sold nor may offers to buy be accepted prior to the time the Registration Statement becomes effective. The filing of the Registration Statement does not affect the statutory pre‐emption rights of shareholders in the Company.

    A copy of the Registration Statement may be obtained on the SEC's website at www.sec.gov.



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  29. NEW YORK and LONDON, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced its CEO and CSO, Dr. Kunwar Shailubhai, will participate in a fireside chat via a video link on Thursday 21 January 2021 at 3 pm ET / 8 pm GMT to provide updates on the Company.

    Date:Thursday 21 January 2021
    Time:3 pm U.S. Eastern / 8 pm GMT
    Webcast:https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in…

    NEW YORK and LONDON, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced its CEO and CSO, Dr. Kunwar Shailubhai, will participate in a fireside chat via a video link on Thursday 21 January 2021 at 3 pm ET / 8 pm GMT to provide updates on the Company.

    Date:Thursday 21 January 2021
    Time:3 pm U.S. Eastern / 8 pm GMT
    Webcast:https://b-riley-oncology-investor-conference.events.issuerdirect.com/signup

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

      
    For further enquiries: 
      
    United Kingdom Investors: 
    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and Founder

    +44 (0)20 7495 2379
      
    United States Investors: 
    Dave Gentry

    RedChip Companies Inc.
    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com

     

     



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  30. NEW YORK and LONDON, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today provided a further update with respect to the cancellation of admission of its Ordinary Shares to trading on AIM and admission to listing of its ordinary shares (the "Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority ("FCA") (the "Official List") and admission to trading on the main market for listed securities (the "Main Market") of London Stock Exchange plc (the "London Stock Exchange") (together, "Admission").

    As previously announced, the last…

    NEW YORK and LONDON, Jan. 20, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today provided a further update with respect to the cancellation of admission of its Ordinary Shares to trading on AIM and admission to listing of its ordinary shares (the "Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority ("FCA") (the "Official List") and admission to trading on the main market for listed securities (the "Main Market") of London Stock Exchange plc (the "London Stock Exchange") (together, "Admission").

    As previously announced, the last day of trading of the Company's Ordinary Shares on AIM will be today, 20 January 2021 and the AIM Delisting will be effective from 7.00 am 21 January 2021. Admission of shares to the Official List and commencement of dealing in the Ordinary Shares of the Company on the Main Market will be effective from 8.00 am on 21 January 2021.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
      
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
     



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  31. NEW YORK and LONDON, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

    Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record…

    NEW YORK and LONDON, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the appointment of Dr Neil Graham MBBS, MD, MPH as Chief Medical Officer.

    Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Virology, Respiratory, Dermatology, Allergy, & Rheumatology) in early & late stage Clinical Development and in Medical Affairs, with a strong track record for Developing and Accelerating Phase I–IV programs. Multiple IND's, NDA/BLA filings and/or defense and multiple successful launches.

    From 2010 to 2020, Dr Graham was VP of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc., where he managed and oversaw a large portion of the Regeneron pipeline portfolio including leading the immunology and inflammation antibody products across all stages of development from preclinical to post-launch. He was instrumental in the development of DUPIXENT (dupilumab), a blockbuster monoclonal antibody, from Phase 1 through its initial launch for atopic dermatitis, as well as expanding its development into asthma, sinusitis, and eight other indications. During his tenure at Regeneron, Dr. Graham also led the product development for KEVZARA (sarilumab), an IL-6R antibody for rheumatoid arthritis, and REGN3500, an anti-IL33 antibody for asthma and COPD. As part of this role he built innovative, high-performing development teams and managed the Regeneron's regulatory filings, interactions with regulatory agencies, product launches, and business development and licensing activities across its product portfolio.

    Prior to Regeneron, Dr. Graham served as Senior Vice President, Program and Portfolio Management at Vertex, where he oversaw the team of program leaders and managers across the portfolio from Phase 1 through launch, including Telaprevir for hepatitis C (HCV), and two innovative product candidates for cystic fibrosis which are now on the market. Previously, he held roles as CMO at Trimeris Inc. and XTL Biopharmaceuticals and worked in HIV Medical Affairs at Glaxo Welcome. Earlier in his career, Dr. Graham was an Associate Professor of Medicine and Epidemiology at John Hopkins University, School of Hygiene and Public Health. He is the author of five chapters and books and more than 140 peer-reviewed journal articles. Dr. Graham earned an M.D., M.B.B.S., and M.P.H. from the University of Adelaide in Australia. 

    Dr. Graham stated: "I am excited to join Tiziana to help develop its unique monoclonal antibody platform for autoimmune diseases. Tiziana's ability to deliver antibody immunotherapeutics via oral and nasal routes is a potential game-changer for patients and physicians alike."

    Kunwar Shailubhai, CEO of Tiziana said: "We are very excited about Dr. Graham's addition to the Tiziana team. Dr Graham's invaluable experience at Regeneron and Vertex in different disciplines is a great fit for the Tiziana pipeline."

    "We are delighted to have Dr. Graham join the Tiziana team. His knowledge and experience at Regeneron in developing blockbuster monoclonal antibody drugs such as Dupixent will be invaluable in developing Foralumab and our anti IL-6Drug, TZLS-501," said Chairman and Founder Gabriele Cerrone

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
     

    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner

     
     

    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
    +44 (0)20 3981 4173



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  32. NEW YORK and LONDON, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that it is participating in the J.P. Morgan 39th Annual Healthcare Conference 2021.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with conference attendees. With topline data from our COVID-19 trial expected this month, multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases in the longer-term, we are well positioned to achieve…

    NEW YORK and LONDON, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that it is participating in the J.P. Morgan 39th Annual Healthcare Conference 2021.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with conference attendees. With topline data from our COVID-19 trial expected this month, multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases in the longer-term, we are well positioned to achieve a series of important milestones that can provide a positive and lasting impact on our valuation in the months and quarters ahead."

    The J.P. Morgan Health Community Conference was created for health leaders and transformers who are working to change the current paradigms of health and wellness. The Community features guests who are advancing, developing, designing, applying and funding real solutions to improve personal and population health.

    Please visit http://www.tizianalifesciences.com/about-us/ or www.TLSAinfo.com for more information and to view the latest investor presentation.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

    U.S. Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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  33. NEW YORK and LONDON, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that it is participating in Biotech Showcase™ 2021 and providing an on-demand company presentation. Registered attendees to Biotech Showcase can now access recorded company presentations prior to the actual event. 24x7 on-demand access allows attendees to view presentations at their convenience, avoiding conflicts with busy meeting schedules during the main event week.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with…

    NEW YORK and LONDON, Jan. 11, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, today announced that it is participating in Biotech Showcase™ 2021 and providing an on-demand company presentation. Registered attendees to Biotech Showcase can now access recorded company presentations prior to the actual event. 24x7 on-demand access allows attendees to view presentations at their convenience, avoiding conflicts with busy meeting schedules during the main event week.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with conference attendees. With topline data from our COVID-19 trial expected this month, multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases longer-term, we are well positioned to achieve a series of important milestones that can provide a positive and lasting impact on our valuation in the months and quarters ahead."

    Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry's largest gatherings and busiest weeks.

    "We are delighted that Tiziana Life Sciences will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."

    To learn more about registration options for Biotech Showcase, click here.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

    U.S. Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com



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    • Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated
    • The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses
    • This trial is the first to evaluate nasally administered Foralumab to improve the immune system's fight against coronaviruses

    NEW YORK and LONDON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the completion of its clinical study in Brazil investigating nasally administered Foralumab, its proprietary human monoclonal…

    • Anecdotal feedback from Foralumab-treated patients was positive and suggests that the treatment was well-tolerated
    • The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses
    • This trial is the first to evaluate nasally administered Foralumab to improve the immune system's fight against coronaviruses

    NEW YORK and LONDON, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, announces the completion of its clinical study in Brazil investigating nasally administered Foralumab, its proprietary human monoclonal antibody, either alone or in combination with orally administered dexamethasone in COVID-19 patients.

    The clinical study was completed in collaboration with scientific teams at the Harvard Medical School (Boston, USA), Santa Casa de Misericórdia de Santos Hospital (Santos, Brazil) and INTRIALS, a world-class, full-service Latin American CRO based in São Paulo, Brazil. The last patients in the trial received their final dose on 21 December 2020.

    The topline data from the trial is expected to be available in January 2021.

    Because COVID-19 enters through the nasal and respiratory passage, the proprietary nasal formulation and nasal delivery of Foralumab is an innovative approach to provide immediate relief to COVID-19 patients.

    Dr. Howard Weiner (the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center, and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital) commented:

    "Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems. Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients."

    Dr Thais Moreira, the lead scientist and coordinator of the clinical trial, stated:

    "We are delighted to receive positive feedback from patients treated in the clinical trial. Among the positive results patients reported, the most common was that the treatment resulted in the rapid improvement in smell sensation, which is frequently lost in COVID-19 patients."

    Dr. Kimble Matos, the lead coordinating physician of the study, commented:

    "The observations made during the Clinical study did not show any adverse events."

    The clinical study enrolled a total of 39 patients with moderate to severe COVID-19 who did not require the use of a ventilator at the beginning of the study. This study had three cohorts: control (n=16), nasally administered Foralumab (n=12), and nasally administered Foralumab with 3 days of priming with orally administered 6 mg dexamethasone (n=11).

    • The primary endpoint of this study was safety of the treatment, and secondary endpoints were to evaluate the effect of treatment on disease severity symptoms, nasal tolerance, sense of smell, and biomarkers for disease progression. The pharmacokinetics of nasally administered Foralumab will also be evaluated.
    • Patient reported outcome to assess clinical responses related to COVID-19 symptoms, as per the FDA guidelines, will also be collected.

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented:

    "While we expect to get the topline data in January 2021, we are delighted with the positive feedback received from the treated patients. This is the first-in-class and scientifically logical approach to improve the human immune system by stimulating Tregs to suppress lung inflammation, and to dampen cytotoxic CD8+ T cell responses in the nasal and respiratory tract, the primary sites of the COVID-19 virus.

    "We believe this approach could potentially provide benefits to patients already infected with COVID-19 and its newly identified variants. Thus, our therapeutic approach to provide rapid relief to patients already suffering with the diseases is particularly important, because vaccination is primarily to prevent COVID-19 infection, but it may not be useful for treatment of COVID-19 patients."

    A further announcement will be made in due course.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379




    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
     



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  34. This announcement is an advertisement and not a prospectus. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. Investors should not purchase any transferable securities referred to in this announcement except on the basis of information contained in the prospectus (the "Prospectus") in its final form that is published by Tiziana Life Sciences plc in connection with the admission of the Company's ordinary shares (the "Ordinary Shares") to listing on the standard segment of the Official List of the Financial Conduct Authority (the "FCA") and to trading on the main market for listed securities (the "Main Market") of London

    This announcement is an advertisement and not a prospectus. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. Investors should not purchase any transferable securities referred to in this announcement except on the basis of information contained in the prospectus (the "Prospectus") in its final form that is published by Tiziana Life Sciences plc in connection with the admission of the Company's ordinary shares (the "Ordinary Shares") to listing on the standard segment of the Official List of the Financial Conduct Authority (the "FCA") and to trading on the main market for listed securities (the "Main Market") of London Stock Exchange plc (the "London Stock Exchange"). This announcement is not an offer to sell, or a solicitation of an offer to acquire, securities in the United States, Australia, Canada, Japan or in any other jurisdiction.

    LONDON and NEW YORK, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces, further to the announcement of 17 December 2020, that the Company has issued a prospectus in connection with its admission to listing of its ordinary shares (the "Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority ("FCA") (the "Official List") and admission to trading on the main market for listed securities (the "Main Market") of London Stock Exchange plc (the "London Stock Exchange") (together, "Admission").

    Expected timetable

    Publication of Prospectus      18 December 2020
    Last day of trading of the Shares on AIM20 January 2021
    Expected delisting of the Shares from AIM7.00 am on 21 January 2021
    Expected admission of the Shares to the Official List8.00 am on 21 January 2021
    Expected commencement of dealings of the Shares on the Main Market8.00 am on 21 January 2021

    The times and dates set out in the expected timetable of principal events above and mentioned in this document, and in any other document issued in connection with Admission are subject to change by the Company, in which event details of the new times and dates will be notified to the FCA, the London Stock Exchange and, where appropriate, shareholders.

    The Prospectus was approved by the FCA on 18 December 2020 and is available to be viewed on the Company's website at: www.tizianalifesciences.com. An electronic copy of the Prospectus will also be submitted to the National Storage Mechanism and will be available shortly for inspection at: https://data.fca.org.uk/#/nsm/nationalstoragemechanism.

    Tiziana Life Sciences plc is a company incorporated in England and Wales with company number 03508592. The Ordinary Shares are registered with ISIN GB00BKWNZY55, SEDOL code BKWNZY5 and TIDM TILS. It is expected that Admission will become effective and that dealings will commence at 8.00 am on 21 January 2021. Trading in the Company's shares on AIM will be cancelled simultaneously with Admission.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged the release of this information is Keeren Shah, Finance Director of Tiziana.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder



    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated Adviser)

    Liam Murray / Jo Turner



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



    + 44 (0)20 3981 4173

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.



    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com



     



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  35. LONDON and NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces it has applied to list its ordinary shares ("Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority ("FCA") (the "Official List") and admission to trading on the London Stock Exchange plc's (the "London Stock Exchange") main market ("Main Market") for listed securities (together, "Admission"). The Board has taken this decision as it believes that a standard listing will afford Tiziana greater flexibility in pursuing its strategy as an international…

    LONDON and NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces it has applied to list its ordinary shares ("Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority ("FCA") (the "Official List") and admission to trading on the London Stock Exchange plc's (the "London Stock Exchange") main market ("Main Market") for listed securities (together, "Admission"). The Board has taken this decision as it believes that a standard listing will afford Tiziana greater flexibility in pursuing its strategy as an international company.

    Pursuant to AIM Rule 41 of the AIM Rules for Companies, the Company hereby gives notice of the intended cancellation of trading of its Ordinary Shares on the AIM market of the London Stock Exchange ("AIM").

    Admission will be through an introduction of the existing Ordinary Shares. The Company will not be issuing new shares in conjunction with the proposed Admission or the publication of the related prospectus. It is expected that the Company will publish its prospectus in connection with Admission on 18 December 2020 and it is anticipated that the Ordinary Shares will be admitted to the Official List, commence trading on the Main Market and simultaneously trading will be cancelled on AIM on 21 January 2021 at 07:00 am (being at least 20 business days after this announcement). The Company's shares will continue to be registered with their existing ISIN number GB00BKWNZY55 and SEDOL number BKWNZY5. The Company's ticker symbol will continue to be TILS. The process has taken longer than expected due to circumstances beyond the control of the Company.

    The prospectus will, when issued, be made available on the Company's website at www.tizianalifesciences.com, and will be available for inspection at the offices of Orrick, Herrington & Sutcliffe (UK) LLP, 107 Cheapside, London, EC2V 6DN between the hours of 9.30 am and 5.30 pm on any Business Day (subject to current COVID restrictions).

    The Company's existing shareholders should consult their own tax advisers as to the tax implications of the Company's proposed move to the Main Market.

    Further announcements will be made in due course.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379
      
    Cairn Financial Advisers LLP (Nominated Adviser)

    Liam Murray / Jo Turner

    +44 (0)20 7213 0880
      
    Optiva Securities Limited (Broker)

    Robert Emmet

    + 44 (0)20 3981 4173

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.



    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com

     



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  36. NEW YORK and LONDON, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced its CEO and CSO Dr. Kunwar Shailubhai will host a conference call on Wednesday, 2 December 2020 at 4:15 p.m. ET to provide updates on the Company. Dr. Shailubhai will provide updates on the Company's proposed move from AIM to the Standard Segment of the Main Market of the London Stock Exchange, ongoing clinical trials, as well as other recent developments in Tiziana Life Sciences.

    Date:Wednesday, 2 December 2020
    Time:4:15 p.m. Eastern Time
    Live Call:+1-877-425-9470 (U.S. Toll-Free) or +1-201-389-0878

    NEW YORK and LONDON, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced its CEO and CSO Dr. Kunwar Shailubhai will host a conference call on Wednesday, 2 December 2020 at 4:15 p.m. ET to provide updates on the Company. Dr. Shailubhai will provide updates on the Company's proposed move from AIM to the Standard Segment of the Main Market of the London Stock Exchange, ongoing clinical trials, as well as other recent developments in Tiziana Life Sciences.

    Date:Wednesday, 2 December 2020
    Time:4:15 p.m. Eastern Time
    Live Call:+1-877-425-9470 (U.S. Toll-Free) or +1-201-389-0878 (International)
    Webcast:http://public.viavid.com/index.php?id=142634

    For interested individuals unable to join the conference call, a dial-in replay of the call will be available until 16 December 2020 and can be accessed by dialing +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International) and entering replay pin number: 13713850.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.



    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com



    Primary Logo

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  37. LONDON and NEW YORK, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that it has been notified that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman has a beneficial interest, purchased 45,000 ordinary shares of 3p each in the market at a price of 84p per share.

    The acquisition takes Mr Cerrone's interests from 34.029% to 34.052% (within the 1% incremental threshold under Note 11 to Rule 9 of the UK Takeover Code).

    1.Details of PDMR / person closely associated
    a)Name

    Gabriele Cerrone
    2.Reason for the notification

    a)Position

    LONDON and NEW YORK, Nov. 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that it has been notified that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman has a beneficial interest, purchased 45,000 ordinary shares of 3p each in the market at a price of 84p per share.

    The acquisition takes Mr Cerrone's interests from 34.029% to 34.052% (within the 1% incremental threshold under Note 11 to Rule 9 of the UK Takeover Code).

    1.Details of PDMR / person closely associated
    a)Name



    Gabriele Cerrone
    2.Reason for the notification



    a)Position / status



    Executive Chairman
    b)Initial notification /amendment



    Initial notification
    3.Details of the issuer



    a)Name



    Tiziana Life Sciences plc
    b)LEI



    213800CED47HI8PIOB36
    4.Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type  of transaction; (iii) each date; and (iv) each place where transactions have  been conducted
    a)Description of the financial instrument



    Ordinary Shares of 3p each
    b)Identification code of the Financial Instrument



    ISIN for Tiziana Life Sciences plc: GB00BKWNZY55
    c)Nature of the transaction



    Market Purchase
    d)Price(s) and volume(s)84p



    45,000
    f)Date of the transaction



    18 November 2020
    g)Place of the transaction



    XLON  

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged the release of this information is Keeren Shah, Finance Director of Tiziana.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

     +44 (0)20 7495 2379
       
    Cairn Financial Advisers LLP (Nominated Adviser)

    Liam Murray / Jo Turner

     +44 (0)20 7213 0880
       
    Optiva Securities Limited (Broker)

    Robert Emmet

     + 44 (0)20 3981 4173
       

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.

     Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com

     



    Primary Logo

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  38. First Ever Study with take-home capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody

    • Potential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn's Disease
    • Crohn's Disease Therapeutics Market Size $4.7 Billion by 2025

    Phase1b/2 clinical study to be conducted in the United States and several European countries

    NEW YORK and LONDON, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced it is collaborating with Parexel Biotech ("Parexel"), a division of a leading global clinical research organization…

    First Ever Study with take-home capsules of Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody

    • Potential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn's Disease

    • Crohn's Disease Therapeutics Market Size $4.7 Billion by 2025

    Phase1b/2 clinical study to be conducted in the United States and several European countries

    NEW YORK and LONDON, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced it is collaborating with Parexel Biotech ("Parexel"), a division of a leading global clinical research organization ("CRO"), Parexel International (IRL) Limited, to conduct a global Phase 1b/2 trial with enteric-coated capsules of formulated Foralumab, the only fully human anti-CD3 monoclonal antibody ("mAb") - as a therapy for patients with moderate to severe Crohn's Disease ("CD"). This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. and Europe.

    Dr. Howard L. Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented:

    "We understand that this will be the first-ever study with ‘take-home' capsules of any mAb for immunotherapies for human diseases. We believe the scientific rationale for oral treatment with Foralumab is logical to facilitate topical action at the inflamed sites in the gastrointestinal tract. This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field."

    "Recently, we also successfully demonstrated that nasally administered Foralumab is not only well-tolerated, but also produced desirable immunological responses. Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits."

    The CD therapeutic market size will be worth $4.7 billion by 2025, according to Grand View Research1. CD is a chronic disorder of the immune system that causes inflammation throughout the digestive tract. Although the specific causes of CD are still not clearly understood, severe gut inflammation caused by an overactive immune system attacking the intestines, colon and other organs appears to contribute to disease pathology. Thus, immunosuppressive agents and anti-TNF (Tumour Necrosis Factor) immunotherapies represent the main therapeutic options to maintain remission in CD. However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Oral administration with take-home capsules of Foralumab is a very attractive approach as it may provide local action to treat gut inflammation in patient with CD. Additionally, oral capsules provide the convenience of home use, and increase patient compliance by eliminating the need for infusions in a clinic or hospital setting.

    "The prevalence of inflammatory bowel disease is rising globally, imposing a significant burden both on patients as well as healthcare systems worldwide," said Sy Pretorius, MD, Parexel Executive Vice President and Chief Medical & Scientific Officer. "We're excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn's patients with another option in their repertoire of treatments to combat this devastating disease."

    Recently, Tiziana announced positive results from its Phase 1 study showing that oral treatment with Foralumab was well-tolerated in healthy volunteers, with no drug-related safety issues even at the highest dose of 5 mg2. Oral administration of anti-CD3 monoclonal antibody is a novel approach to induce an anti-inflammatory immune response to suppress inflammation by inducing T regulatory (Tregs) cells in animal studies3,4. Importantly, oral treatment with OKT3, a mouse anti-CD3 mAb, showed clinical responses which were reversed following discontinuation of treatment, suggesting oral treatment with OKT3 may have potential for treatment of moderate to severe ulcerative colitis5.

    Dr. Shailubhai, CEO & CSO of Tiziana Life Sciences, commented:

    "Previously, we reported that oral administration of Foralumab was well-tolerated and that the treatment did not result in severe toxicities that are so commonly observed with intravenous (IV) administration of anti-CD3 mAbs, suggesting that oral administration may be able to minimize toxicities and thereby improve clinical outcome. Our patent on the core formulation technologies covering alternative routes of administration for immunotherapies has been already granted in the USA and it is pending in other countries world-wide. We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies."

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    Cited References:

    1. Grand View Research August 2018 (https://www.grandviewresearch.com/press-release/global-crohns-disease-therapeutics-market).

    2. Tiziana Life Sciences January 9, 2020 Press Release (https://ir.tizianalifesciences.com/news-releases/news-release-details/tiziana-life-sci-plc-further-re-foralumab-phase-1-trial)

    3. da Cunha, A. P., and Weiner, H. L. (2012) Induction of immunological tolerance by oral anti-CD3. Clin Dev Immunol 2012, 425021

    4. Ogura, M., Deng, S., Preston-Hurlburt, P., Ogura, H., Shailubhai, K., Kuhn, C., Weiner, H. L., and Herold, K. C. (2017) Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. Clin Immunol 183, 240-246

    5. Boden, E. K., Canavan, J. B., Moran, C. J., McCann, K., Dunn, W. A., Farraye, F. A., Ananthakrishnan, A. N., Yajnik, V., Gandhi, R., Nguyen, D. D., Bhan, A. K., Weiner, H. L., Korzenik, J. R., and Snapper, S. B. (2019) Immunologic Alterations Associated With Oral Delivery of Anti-CD3 (OKT3) Monoclonal Antibodies in Patients With Moderate-to-Severe Ulcerative Colitis. Crohn's & Colitis 360, Volume 1, Issue 2, July 2019, otz009

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances Tregs and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    About Parexel

    Parexel Biotech is a division of leading global clinical research organization (CRO), Parexel International (IRL) Limited, and provides tailored solutions for biotech and medical device companies to accelerate their development goals and help them achieve faster market access.

    Parexel is focused on supporting the development of innovative therapies to improve patient health. During the COVID-19 crisis, we continue to be committed to our customers' business while putting the safety of patients, client partners and our employees at the heart of everything we do. To learn more about our efforts related to COVID-19, as well as the experts, innovations and processes we have in place to navigate the rapidly changing landscape, visit us at website and follow us on LinkedInTwitter and Instagram.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379
      
    Cairn Financial Advisers LLP (Nominated Adviser)

    Liam Murray / Jo Turner

    +44 (0)20 7213 0880
      
    Optiva Securities Limited (Broker)

    Robert Emmet

    + 44 (0)20 3981 4173

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.

    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com

      

    Primary Logo

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    • Highly innovative first-in-class study for treating COVID-19 disease with nasally administered drug
    • Trial facilitated with collaboration of Harvard Medical School and one of the world's top Neurologist, Dr. Howard Weiner
    • Patent for potentially revolutionary nasally administered delivery system already filed
    • Clinical Data Expected by End of Year

    Tiziana Life Sciences plc

    ("Tiziana" or the "Company")

    NEW YORK and LONDON, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces initiation of a collaborative clinical study investigating nasally administered Foralumab either…

    • Highly innovative first-in-class study for treating COVID-19 disease with nasally administered drug

    • Trial facilitated with collaboration of Harvard Medical School and one of the world's top Neurologist, Dr. Howard Weiner
    • Patent for potentially revolutionary nasally administered delivery system already filed
    • Clinical Data Expected by End of Year

    Tiziana Life Sciences plc

    ("Tiziana" or the "Company")

    NEW YORK and LONDON, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces initiation of a collaborative clinical study investigating nasally administered Foralumab either alone or in combination with orally administered dexamethasone in COVID-19 patients in Brazil. In view of the importance and urgency, scientific teams at the Harvard Medical School, Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) and at Tiziana are closely collaborating to facilitate initiation of this study in expedited time frames. This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year.  

    "Brazil has reported almost 5.5M Coronavius cases and 159,000 deaths and is considered a global epicenter of the outbreak. Brazil is now experiencing almost 1000 deaths per day. Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs," stated Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

    • Clinical study will start dosing patients on November 3rd, 2020 with clinical data expected to be available before the end of 2020
    • Since reduced or defective levels of T regulatory (Tregs) cells in the blood seem to be associated with the severity of COVID-19 and acute respiratory distress syndrome (ARDS), nasally administered Foralumab, by acting locally, could potentially suppress excessive cytokine storm and hyperinflammation in respiratory tract and lungs of COVID-19 patients
    • A patent application was filed in July 2020 to protect the potential use of nasally administered Foralumab for the treatment of COVID-19 either alone or in combination with other anti-viral drugs.

    Dr Howard Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital, commented: "Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems. Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease." He continued, "My colleague Dr. Thais Moreira worked very closely with clinicians at the Brazilian hospital and the team at the INTRIALS to expedite this highly innovative first-in-class study for treating COVID-19 disease."

    Dr. Rogério Dedivitis, the Clinical director of Santa Casa de Santos, stated: "The Santa Casa hospital, the first hospital founded in Brazil almost 500 years ago, is very pleased to be involved in such an important international clinical study. We are excited and confident that this study will contribute to the better understanding of COVID-19 disease, and importantly also benefit our patients."

    The cytokine storm and hyperinflammation resulting in severe lung damage, followed by respiratory failure are the main underlying reasons for morbidity and mortality in COVID-19 patients (1). Recent clinical evidence suggests that the level of peripheral Tregs is prominently reduced in severely ill COVID-19 patients (2). The clinical data from a recently completed clinical study indicated that the nasal administration of Foralumab stimulated production of Tregs in healthy volunteers (https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers-of-immunomodulation-and-anti-inflammation-in-healthy-volunteers), suggesting that nasal treatment with Foralumab might improve clinical outcome by stimulating Tregs in patients. This is a highly innovative approach, which could also be useful for treatment of patients with Middle Eastern Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute Respiratory Distress Syndrome (ARDS) because depletion of functional Tregs are commonly observed in these diseases.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    Cited References

    1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395: 497–506. doi:10.1016/S0140-6736(20)30183-5
    2. Chen G, Wu D, Guo W, et al. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest 2020; 130: 2620–2629. doi:10.1172/JCI137244

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom: 
    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
      
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner

    +44 (0)20 7213 0880
      
    Optiva Securities Limited (Broker)

    Robert Emmet

    +44 (0)20 3981 4173
      
    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
     

    Primary Logo

    View Full Article Hide Full Article
  39. NEW YORK and LONDON, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that it is confirming the timetable for the Accustem Sciences Limited ("Accustem") demerger (the "Demerger") for holders of the Company's American Depositary Receipts ("ADRs").

    The demerger of Accustem is the spinoff of Tiziana's StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer. In two posters presented at ASCO, StemPrintER outperformed Oncotype DX in 10-year risk prediction in more than 800 ER+/HER2-postmenopausal breast cancer patients, including…

    NEW YORK and LONDON, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that it is confirming the timetable for the Accustem Sciences Limited ("Accustem") demerger (the "Demerger") for holders of the Company's American Depositary Receipts ("ADRs").

    The demerger of Accustem is the spinoff of Tiziana's StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer. In two posters presented at ASCO, StemPrintER outperformed Oncotype DX in 10-year risk prediction in more than 800 ER+/HER2-postmenopausal breast cancer patients, including lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients. The integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2-breast cancer patients demonstrated that the next-generation StemPrintER RiskScore (SPARE) model is approximately 20% superior to the traditional clinicopathological parameters, as expressed by the CTS, in providing prognostic information in more than 1,800 ER+/HER2-patients analyzed; and up to 40%-50% more accurate in lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients.

    The timetable for the Demerger and the record date for distribution of the Accustem ADRs to the holders of Tiziana ADRs is as follows:

    Final Court Hearing to Approve Reduction of Capital27 October 2020*
      
    Tiziana ADR I&C Register closure28 October 2020**
      
    Reduction of Capital becomes effective29 October 2020*
      
    Completion of Demerger30 October 2020*
      
    Record date for holders of ADRs6 November 2020***
      

    * These dates are the same for holders of Tiziana Shares and Tiziana ADRs

    ** From 5:00pm (EDT) on 28 October 2020, the portion of the Tiziana ADR register regarding the issuance and cancellation of ADRs held by JPMorgan as Depositary Bank for the ADR Program will be closed until this action is completed. This action will not suspend Nasdaq trading of the Tiziana ADSs. However, for technical reasons, the ADR Record Date can only be established at a later date.

    ***Due to complexities of the US securities laws and the rules of the Nasdaq Capital Market, the ex-entitlement date for holders of the Tiziana ADRs (traded on Nasdaq) is dependent on the actual delivery date of the new Accustem ADRs (which will each represent 2 Accustem Shares to mirror the position of the Tiziana ADRs); this is different than the "ex date" of the Tiziana Shares for the purposes of the corporate actions timetable of the London Stock Exchange plc, but the difference has no economic impact on holders of the ADRs.

    The Company plans to file a registration statement for the new Accustem Shares with the SEC and create a new registered Accustem ADR program. The Accustem ADRs will be distributed to the holders of Tiziana ADRs as of the Record Date as and when the registration statements become effective. This is likely to be on or about the date upon which holders of Tiziana Shares receive their new Accustem Shares and it is further likely to be on or about the date upon which the new Accustem Shares are admitted to trading on the Main Market of the London Stock Exchange plc (subject to appropriate regulatory review and approvals). The Company will endeavour to ensure dates coincide for these events in so far as is practicable and will publish additional updates to timelines in due course.

    For further enquiries:

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.

    Office +1 800 RED CHIP (733 2447)

    Cell +1 407-491-4498 (USA)

    dave@redchip.com

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Hana Malik, Investor Relations

    +44 (0)20 7495 2379

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  40. LONDON, Oct. 02, 2020 (GLOBE NEWSWIRE) -- At the General Meeting of the Company (NASDAQ:TLSA) held at 11.00 a.m. on 2 October 2020, both of the resolutions were duly passed.

    The anticipated timetable for the demerger of Accustem Sciences Limited (to be re-registered as Accustem Sciences Plc) is as follows:
    14 October 2020 – Court Hearing for Directions
    27 October 2020 – Final Court Hearing to approve Reduction of Capital
    29 October 2020 –Reduction of Capital becomes effective
    7:00 a.m. on 30 October 2020 – Demerger Record Time
    30 October 2020 – Completion of Demerger
    2 November 2020 – Ex-entitlement date for Accustem Shares

    The Company confirms that it has now received clearance from HMRC under section 138(1) of the Taxation of Chargeable Gains…

    LONDON, Oct. 02, 2020 (GLOBE NEWSWIRE) -- At the General Meeting of the Company (NASDAQ:TLSA) held at 11.00 a.m. on 2 October 2020, both of the resolutions were duly passed.

    The anticipated timetable for the demerger of Accustem Sciences Limited (to be re-registered as Accustem Sciences Plc) is as follows:

    14 October 2020 – Court Hearing for Directions

    27 October 2020 – Final Court Hearing to approve Reduction of Capital

    29 October 2020 –Reduction of Capital becomes effective

    7:00 a.m. on 30 October 2020 – Demerger Record Time

    30 October 2020 – Completion of Demerger

    2 November 2020 – Ex-entitlement date for Accustem Shares

    The Company confirms that it has now received clearance from HMRC under section 138(1) of the Taxation of Chargeable Gains Act 1992 that HMRC is satisfied that the Demerger is being effected for bona fide commercial reasons and does not form part of a scheme or arrangements of which the main purpose, or one of the main purposes, is avoidance of a liability to capital gains tax or corporation tax. Accordingly, Shareholders should not be treated, by virtue of the receipt of Accustem Shares under the Demerger, as making a disposal of their Tiziana Shares for the purposes of taxation of chargeable gains.

    Capitalised terms used in this announcement have the meanings given to them in the circular to shareholders dated 16 September 2020.

    The results of the poll, including the proxy voting, will be available shortly on the Company's website at https://www.tizianalifesciences.com/

    The person who arranged for the release of this announcement was Gabriele Cerrone, Chairman.

    THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 596/2014.

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION.

    For further enquiries:

    United Kingdom Investors: 
      
    Tiziana Life Sciences Plc

    +44 (0)20 7495 2379
    Gabriele Cerrone, Chairman and Founder 
      
    Cairn Financial Advisers LLP (Nominated Adviser)

    +44 (0)20 7213 0880
    Liam Murray/Jo Turner 
      
    Optiva Securities Limited (Broker)

    + 44 (0)20 3981 4173
    Robert Emmet 
      
    United States Investors:Office 1 800 RED CHIP (733 2447)

     Cell 407-491-4498 (USA)
    Dave Gentrydave@redchip.com
    RedChip Companies Inc. 

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  41. LONDON and NEW YORK, Sept. 25, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced an interview with Dr. Kunwar Shailubhai, CEO, will air on The RedChip Money Report television program. The interview will air Sunday, 27 September 2020, at 6 p.m. EST on Bloomberg International, available in 100+ million homes across Europe.

    In the exclusive interview, Dr. Shailubhai discusses the Company's planned spinout of StemPrintER into a new company, Accustem Sciences, as well as its plan to initiate a clinical study with nasally administered Foralumab, a fully human anti-CD3 monoclonal…

    LONDON and NEW YORK, Sept. 25, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced an interview with Dr. Kunwar Shailubhai, CEO, will air on The RedChip Money Report television program. The interview will air Sunday, 27 September 2020, at 6 p.m. EST on Bloomberg International, available in 100+ million homes across Europe.

    In the exclusive interview, Dr. Shailubhai discusses the Company's planned spinout of StemPrintER into a new company, Accustem Sciences, as well as its plan to initiate a clinical study with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody, in patients with COVID-19 in Brazil.

    The interview will also air in the US on the Action Channel on Sunday, 27 September 2020, at 11 a.m. ET and is available via live stream on American Business TV.

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
     +44 (0)20 7495 2379


    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner



      

    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet





    United States:



    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    Office: 1.800.RED.CHIP (733.2447)

    Cell: 407.491.4498

    dave@redchip.com

     +44 (0)20 3981 4173

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  42. LONDON and NEW YORK, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), is pleased to note the publication of a new analyst research note from H C Wainwright & Co which is available on the Company's website at https://ir.tizianalifesciences.com/static-files/0bae55ef-6589-43f2-a4bd-65be16b3dce1

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease…

    LONDON and NEW YORK, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), is pleased to note the publication of a new analyst research note from H C Wainwright & Co which is available on the Company's website at https://ir.tizianalifesciences.com/static-files/0bae55ef-6589-43f2-a4bd-65be16b3dce1

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:
      
    United Kingdom: 
      
    Tiziana Life Sciences plc 
      
    Gabriele Cerrone, Chairman and founder+44 (0)20 7495 2379
      
    Cairn Financial Advisers LLP (Nominated adviser) 
      
    Liam Murray / Jo Turner+44 (0)20 7213 0880
      
    Optiva Securities Limited (Broker) 
      
    Robert Emmet+44 (0)20 3981 4173
      
    United States: 
      
    Investors 
      
    Dave Gentry 
      
    RedChip Companies Inc. 
      
    001 407 – 491 – 4498 
      
    Dave@redchip.com 

     

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  43. Nasal Administration of Foralumab is a potentially transformative approach for treating patients with Covid-19

    NEW YORK and LONDON, Sept. 17, 2020 (GLOBE NEWSWIRE) --  Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that it has signed an agreement for a collaborative clinical study investigating nasally administered Foralumab in COVID-19 patients in Brazil, either alone or in combination with orally administered dexamethasone. The Company announced on July 31, 2020 its filing of a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody…

    Nasal Administration of Foralumab is a potentially transformative approach for treating patients with Covid-19

    NEW YORK and LONDON, Sept. 17, 2020 (GLOBE NEWSWIRE) --  Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that it has signed an agreement for a collaborative clinical study investigating nasally administered Foralumab in COVID-19 patients in Brazil, either alone or in combination with orally administered dexamethasone. The Company announced on July 31, 2020 its filing of a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19 either alone or in combination with other anti-viral drugs.  

    • Clinical study anticipated to start in the next few weeks with clinical data potentially available before the end of 2020
    • Scientific rationale for use of Foralumab as a treatment for COVID-19 patients is to help modulate the human immune system to suppress a possible "Cytokine storm" and to potentially reduce respiratory failure in COVID-19 patients

    The "Cytokine storm" (aka cytokine release syndrome) and hyperinflammation resulting in severe lung damage, followed by respiratory failure are the main underlying reasons for morbidity and mortality in COVID-19 patients (1). Recent clinical evidence suggests that the level of peripheral T regulatory cells (Tregs) is prominently reduced in severely ill COVID-19 patients (2), which could be one of the reasons for the hyperactivated immune system and damaged lungs in these patients. Since the reduction in Tregs and activation of the immune system are commonly observed in patients with Middle Eastern Middle Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS-CoV-1), COVID-19 and Acute Respiratory Distress Syndrome (ARDS), we believe that stimulation of Tregs is a highly innovative approach for the treatment of patients with these diseases.

    The Company has developed a robust formulation for delivery of Foralumab using a nasal spray device and has successfully completed a Phase 1 clinical trial demonstrating that the treatment was well-tolerated up to 250 microg/day and that it stimulated Tregs (https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers). Thus, we believe the clinical strategy with nasal administration of Foralumab either alone or in combination with dexamethasone to treat COVID-19 patients is highly innovative and scientifically very sound.

    "Nasal administration of Foralumab to modulate the human immune system is a potentially transformative approach for treating patients with a variety of human diseases with dysregulated immune systems. Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease," commented Dr. Howard Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital. He continued, "modulating the immune system with nasal anti-CD3 is a first-in-class immunotherapeutic approach to treat COVID-19 disease."

    "Our proprietary immunotherapeutic approach, employing nasal administration of Foralumab to modulate the immune system, aims to supercharge Tregs to suppress inflammation, and to dampen cytotoxic CD8+ T cell responses in the nasal and respiratory tract, the primary sites of Covid-19. In view of the importance and urgency to develop an effective therapy for COVID-19 immediately, our Tiziana Life Sciences team, scientists at the Harvard Medical School and the scientific team at Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) are working very quickly to start this clinical study in the next few weeks such that clinical data could be available before the end of this year," commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014

    The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    Cited References

    1. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet 2020; 395: 497–506. doi:10.1016/S0140-6736(20)30183-5



    2. Chen G, Wu D, Guo W, et al. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest 2020; 130: 2620–2629. doi:10.1172/JCI137244

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that whilst targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating Phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
     



    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 



     
     



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



     



     



    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
    +44 (0)20 3981 4173

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  44. NEW YORK and LONDON, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, and focused on innovative therapeutics for oncology, inflammation and infectious disease, today announced plans for demerging its StemPrintER asset into a separate and independently listed public company, Accustem Sciences Limited.

    StemPrintER is a best-in-class genomic signature-based assay for the prognosis of early and late recurrence of ER+/HER2 breast cancer in early stage breast cancer patients.  In a side-by-side comparison study, StemPrintER was 40% more accurate than the Oncotype DX assay.  In…

    NEW YORK and LONDON, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, and focused on innovative therapeutics for oncology, inflammation and infectious disease, today announced plans for demerging its StemPrintER asset into a separate and independently listed public company, Accustem Sciences Limited.

    StemPrintER is a best-in-class genomic signature-based assay for the prognosis of early and late recurrence of ER+/HER2 breast cancer in early stage breast cancer patients.  In a side-by-side comparison study, StemPrintER was 40% more accurate than the Oncotype DX assay.  In 2019, Tiziana presented two posters at the American Society for Clinical Oncology (ASCO) that showed StemPrintER outperformed OncoType DX in a 10-year risk prediction in more than 800 ER+/HER2 postmenopausal breast cancer patients. Results demonstrated that the next-generation StemPrintER Risk Score (SPARE) model is approximately 20% superior to the traditional clinicopathological parameters in providing prognostic information in more than 1,800 tissue samples from patients with ER+/HER2- breast cancer and is 40-50% more accurate in lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients. Notably, Exact Sciences purchased the Oncotype DX assay from Genomic Health for $2.8 billion. 

    The Company will hold a shareholders meeting on October 2, 2020 to vote on the planned demerger.  As part of the demerger, Tiziana will provide the new entity with $1.3M in cash.

    Accustem Sciences intends to list on the London Stock Exchange (LSE) in late Q4 2020, and potentially a dual listing on NASDAQ in 2021.  To effect the demerger, Tiziana plans to distribute a 1:1 share dividend to its shareholders with a record date of 0700 London time on October 30, 2020.

    Accustem Sciences will begin the process of seeking CE Mark approval in November of 2020 with anticipated commercialization in Europe in the second quarter of 2021.  Subsequently, the Company also intends to seek FDA approval.

    Gabriele Cerrone, Chairman of Tiziana, commented: "We are extremely pleased to announce the planned spin out of our StemPrintER technology. We believe that we have not received the proper valuation for the technology while it has been part of Tiziana. Thus, we are now fulfilling our promise to shareholders to demerge the asset and create a new public company that will focus exclusively on the commercialization of StemPrintER. Our research indicates we have a far more accurate assay than our competitors, which gives us great confidence as we begin the final steps in monetizing this important technology.

    For more details about the planned demerger and spin out, please see the Company's Form 6-K filed with the U.S. Securities and Exchange Commission on September 16 2020 and the Company's website http://www.tizianalifesciences.com/about-us/

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIM: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation, and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    Forward Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner

    +44 (0)20 7213 0880

    Optiva Securities Limited (Broker)

    Robert Emmet

    +44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com 

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  45. LONDON, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Plc ((LSE: TILS, NASDAQ:TLSA) a biotechnology company focussed on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that, following a strategic review of its clinical trial programs and core focus, it intends to demerge its StemPrintER and SPARE genomics-based personalised medicine business into a separate and independent listed company, Accustem Sciences Limited. The proposed demerger, which requires a court-approved reduction of capital to be completed, will allow Accustem to continue the commercialisation efforts of the StemPrintER platform technology as a separate listed company with cash reserves of approximately £1.0 million.

    LONDON, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Plc ((LSE: TILS, NASDAQ:TLSA) a biotechnology company focussed on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that, following a strategic review of its clinical trial programs and core focus, it intends to demerge its StemPrintER and SPARE genomics-based personalised medicine business into a separate and independent listed company, Accustem Sciences Limited. The proposed demerger, which requires a court-approved reduction of capital to be completed, will allow Accustem to continue the commercialisation efforts of the StemPrintER platform technology as a separate listed company with cash reserves of approximately £1.0 million.

    The proposed timetable for the demerger is as follows:

    11:00 a.m. on 2 October 2020General Meeting to approve the demerger
    14 October 2020First Court Hearing in respect of capital reduction
    27 October 2020Second Court Hearing to approve capital reduction
    29 October 2020Capital reduction becomes effective
    7:00 a.m. on 30 October 2020Demerger Record Time
    30 October 2020Ex-dividend date
    30 October 2020Effective Date of the demerger

     

    A circular was sent to shareholders today (the "Circular") providing further information regarding the demerger and seeking approval from its shareholders at a general meeting. Definitions contained in the Circular have the same meanings when used in this announcement. The Circular is available for download from the Company's Rule 26 website.

    Additional Information regarding the Demerger

    The Demerger will be implemented by Tiziana declaring a dividend in specie on the Tiziana Shares equal to the book value (of approximately £3.07m) of Tiziana's shareholding in StemPrintER Sciences, the entity within the Tiziana group which holds all of the assets and intellectual property relating to StemPrintER and SPARE and £1.0 million in cash.

    The dividend in specie will be satisfied by the transfer by Tiziana to Accustem of the shares in StemPrintER Sciences. In return for this transfer, Accustem will allot Accustem Shares to Tiziana Shareholders who are registered on the Tiziana Share Register at the Demerger Record Time, on the basis of one Accustem Share for each Tiziana Share held by them at that time, save that the number of Accustem Shares to be allotted to the initial subscriber in Accustem (who is, and will at the Demerger Record Time continue to be, a Tiziana Shareholder) will be reduced by the number of Accustem Shares already held by them so that, upon the Demerger becoming effective, each Tiziana Shareholder (including the initial subscriber in Accustem) will hold one Accustem Share for each Tiziana Share held at the Demerger Record Time.

    It is intended that holders of warrants and options over Tiziana Shares will be granted equivalent instruments in respect of Accustem Shares as a part of the Demerger.

    It is intended that Accustem will seek admission to the standard segment of the Official List and admission to trading on the London Stock Exchange plc by way of an IPO in late Q4 2020 ("Accustem Admission") and potentially a dual listing on NASDAQ in 2021.

    Whilst the Accustem Shares will be allotted on the completion of the Demerger, it is unlikely that the process to obtain a standard listing on the Official List and admission to trading on the London Stock Exchange will be complete by the date of completion of the Demerger. Accordingly, no Accustem Shares will be actually issued (or CREST accounts credited or Accustem ADSs issued) until the earlier of (i) Accustem Admission; and (ii) 2 months from the date of the completion of the Demerger. This is to prevent the issue of large numbers of physical share certificates which would then need to be replaced or dematerialised upon Accustem Admission.

    Related Party Transactions

    The Demerger constitutes a related party transaction under Rule 13 of the AIM Rules with Gabriele Cerrone, as a director and substantial shareholder of the Company, and Dr Kunwar Shailubhai, in his capacity as a director and shareholder of the Company "Related Parties", as both will receive Accustem Shares in amounts equal to their shareholdings in the Company on completion of the Demerger. Based upon the Related Parties' shareholding in the Company as at the date of this document, upon completion of the Demerger, the Related Parties will have the following holdings in each of the Company and Accustem:

     Current holding of Tiziana Shares% of current holding of Tiziana SharesExpected % of issued share capital of the Company following the DemergerExpected % of issued share capital of Accustem following the Demerger
    Panetta Partners Limited691,5210.36%691,5210.36%
    Planwise Group Limited63,680,40433.42%63,680,40433.42%
    Dr Kunwar Shailubhai5,0000.002%5,0000.002%

    Note: the above figures assume no changes to the underlying holdings of the named shareholders after publication of this document and before the Record Date.

    Willy Simon and John Brancaccio are deemed to be independent of the Demerger for the purposes of Rule 13 of the AIM Rules. Willy Simon, John Brancaccio and Dr Kunwar Shailubhai, having consulted with the Company's nominated adviser, Cairn Financial Advisers LLP, consider that the terms of the Demerger referred to above are fair and reasonable in so far as the Tiziana Shareholders are concerned.

    NOT FOR DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO ANY JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. THE CONTENTS OF THIS DOCUMENT ARE NOT TO BE CONSTRUED AS LEGAL, FINANCIAL OR TAX ADVICE. EACH PROSPECTIVE INVESTOR SHOULD CONSULT HIS, HER OR ITS OWN SOLICITOR, INDEPENDENT FINANCIAL ADVISER OR TAX ADVISER FOR LEGAL, FINANCIAL OR TAX ADVICE.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed ((LSE: TILS, NASDAQ:TLSA) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients with severe respiratory symptoms.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged the release of this information is Keeren Shah, Finance Director of Tiziana.

    For further enquiries:

    United Kingdom Investors:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder



     
    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated Adviser)

    Liam Murray / Jo Turner



     
    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



     
    + 44 (0)20 3981 4173

    United States Investors:

    Dave Gentry

    RedChip Companies Inc.



     
    Office 1 800 RED CHIP (733 2447)

    Cell 407-491-4498 (USA)

    dave@redchip.com

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  46. NEW YORK and LONDON, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announced the clarification of the reason for filing a corrected amendment registration statement on Form F-6 registering additional American Depositary Shares (ADSs). The registration statement was not filed to register shares for a capital raise, but for the sole purpose of increasing the number of ADSs available for shareholders to exchange ordinary shares of Tiziana for ADSs. Over the past few months, an increasing number of ordinary shares have been exchanged for ADSs. Each ADS represents two (2…

    NEW YORK and LONDON, Aug. 28, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announced the clarification of the reason for filing a corrected amendment registration statement on Form F-6 registering additional American Depositary Shares (ADSs). The registration statement was not filed to register shares for a capital raise, but for the sole purpose of increasing the number of ADSs available for shareholders to exchange ordinary shares of Tiziana for ADSs. Over the past few months, an increasing number of ordinary shares have been exchanged for ADSs. Each ADS represents two (2) ordinary shares.

    The person who arranged for the release of this announcement on behalf of the Company was Keeren Shah, Finance Director of the Company.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIM: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation, and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    For further enquiries:

    United Kingdom: 
    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet 
    + 44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com

    Primary Logo

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  47. NEW YORK and LONDON, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announced that an interview with its CEO and CSO Dr. Kunwar Shailubhai is now available. 

    In the interview, Dr. Shailubhai updates shareholders on its recently issued patents:

    1. Methods and use of anti-CD3 monoclonal antibodies for treatment of Crohn's Disease, including Tiziana's lead drug Foralumab, the first and only fully human monoclonal antibody
    2. Methods and use of anti-IL-6/IL-6 receptor monoclonal antibodies as prophylactic and therapeutic interventions for human diseases, including COVID-19 and…

    NEW YORK and LONDON, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announced that an interview with its CEO and CSO Dr. Kunwar Shailubhai is now available. 

    In the interview, Dr. Shailubhai updates shareholders on its recently issued patents:

    1. Methods and use of anti-CD3 monoclonal antibodies for treatment of Crohn's Disease, including Tiziana's lead drug Foralumab, the first and only fully human monoclonal antibody
    2. Methods and use of anti-IL-6/IL-6 receptor monoclonal antibodies as prophylactic and therapeutic interventions for human diseases, including COVID-19 and other pulmonary diseases
    3. Use of Milciclib in combination with a Tyrosine Kinase Inhibitor such as Sorafenib or Regorafenib for treatment of hepatocellular carcinoma and other cancers

    Dr. Shailubhai also comments on the Tiziana's clinical pipeline and near-term milestones for reporting data for its oral and nasal Phase 2 clinical studies with Foralumab and its plans for clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody for COVID-19. The interview also provides an update on the plan for treatment of hepatocellular carcinoma with its lead drug Milciclib.

    To watch the interview, click here.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    Forward Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com

    Primary Logo

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  48. NEW YORK and LONDON, Aug. 24, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent for methods and use of fully human monoclonal antibody (mAb; TZLS-501) that recognizes both IL-6 receptor (IL-6R) and IL-6 receptor complex with IL-6 (IL-6R/IL-6) for prophylactic and therapeutic intervention for human diseases. The Company initially entered into a world-wide exclusive license from Novimmune, SA., a Swiss Biotechnology company in 2017. The license is currently maintained with Bristol Myers…

    NEW YORK and LONDON, Aug. 24, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent for methods and use of fully human monoclonal antibody (mAb; TZLS-501) that recognizes both IL-6 receptor (IL-6R) and IL-6 receptor complex with IL-6 (IL-6R/IL-6) for prophylactic and therapeutic intervention for human diseases. The Company initially entered into a world-wide exclusive license from Novimmune, SA., a Swiss Biotechnology company in 2017. The license is currently maintained with Bristol Myers Squibb. The patent (No. 10,759,862) will be published by the USPTO on September 1, 2020. The grant of this additional patent on TZLS-501 is of particular significance for the potential treatment of COVID-19 and other pulmonary diseases such as acute respiratory distress syndrome (ARDS). 

    The major distinguishing feature of TZLS-501 is that it acts via a dual mechanism by not only inhibiting IL-6R signaling but also depleting circulating levels of IL-6. This distinctive feature of TZLS-501, a fully human anti-IL-6R mAb, makes it potentially suitable for treatment of COVID-19 and ARDS.  For example, COVID-19 patients often develop an uncontrolled immune response ("cytokine storm") resulting in severe damage to the lung tissue which could lead to respiratory failure. Many studies have also indicated excessive levels of IL-6 in the lungs and in the blood of these patients, and it is believed that the cytokine storm in lungs is primarily due to excessive levels of IL-6. Hence, direct inhalation delivery of TZLS-501 to the lungs using a hand-held nebulizer has the potential to deplete circulating levels of IL-6 and inhibit IL-6R signaling thus providing immediate relief to COVID-19 patients. 

    "The granting of this patent along with our previously filed patent application on inhalation delivery of anti-IL-6 mAbs strengthens our intellectual property for the treatment of lung diseases. We are expediting the clinical development of TZLS-501, GMP manufacturing, simultaneously developing inhalation delivery directly to the lungs using a nebulizer and conducting the inhalation safety toxicology studies in Cynomolgus monkeys. Completion of these studies will enable us to file an IND and initiate a clinical trial in COVID-19 patients by Q1 2021. Subsequently, we plan to use TZLS-501 with the same inhalation delivery technology for the treatment of patients with ARDS", added Dr. Kunwar Shailubhai, CEO & CSO of Tiziana.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

    About TZLS-501

    TZLS-501, a fully human mAb, was acquired from Novimmune, SA, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα can be shed in soluble form, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, a major cause of lung damage, suggests a potential role for TZLS-501 in patient management and treatment of COVID-19.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIM: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation, and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder



    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



    United States:

    Investors

    Dave Gentry

    RedChip Companies Inc.

    407-491-4498

    Dave@redchip.com
    + 44 (0)20 3981 4173

    Primary Logo

    View Full Article Hide Full Article
  49. NEW YORK and LONDON, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent on use of Milciclib in combination with tyrosine kinase inhibitors (TKIs) such as Sorafenib (Nexavar®), Regorafenib (Stivarga®) and Lenvatinib (Lenvima®) for the treatment of hepatocellular carcinoma (HCC) and other cancers in humans. This patent will be published by the USPTO on 1 September 2020 as Patent No. 10,758,541 (Inventor: Kunwar Shailubhai). Like most human cancers, HCC is a complex multi-factorial…

    NEW YORK and LONDON, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent on use of Milciclib in combination with tyrosine kinase inhibitors (TKIs) such as Sorafenib (Nexavar®), Regorafenib (Stivarga®) and Lenvatinib (Lenvima®) for the treatment of hepatocellular carcinoma (HCC) and other cancers in humans. This patent will be published by the USPTO on 1 September 2020 as Patent No. 10,758,541 (Inventor: Kunwar Shailubhai). Like most human cancers, HCC is a complex multi-factorial cancer with multiple underlying mechanisms causing enormous heterogeneity in patient populations. Consequently, patients with HCC often develop resistance towards the monotherapies of existing therapeutics. Thus, there is an urgent need for combination drug treatment approaches targeting different mechanisms to achieve better clinical outcomes.

    Recently, the Company presented two posters on clinical evaluation of Milciclib at the American Society of Clinical Oncology 2020 (ASCO2020). The poster on Phase 2a clinical evaluation of Milciclib, a broad-spectrum inhibitor of cyclin dependent kinases, indicated that the treatment was well-tolerated, and it produced encouraging clinical activity in sorafenib-resistant patients of HCC(1). The second poster was on the evaluation of Milciclib in combination with Regorafenib, a specific TKI drug, in liver transplant patients with HCC recurrence in the MiHRCO (Milciclib and Half Regorafenib CO administration) trial. The combination treatment was safe and produced promising clinical response(2) in these delicate and difficult to treat patients. Additionally, the Company earlier reported data from an animal study suggesting that the combination of Milciclib with Sorafenib, both acting via different mechanisms, suppressed expression of protooncogene c-Myc to produce pronounced synergistic anti-HCC activity(3).   

    Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, commented, "Advanced cases of patients with HCC have limited therapeutic options because of the heterogeneity of the multiple mechanisms underlying the development of drug resistance and limited clinical responses. Thus, combination of drugs with different mechanism of actions are necessary to achieve superior clinical outcome. We are delighted that we now have this key patent on use of Milciclib in combination with other HCC drugs, including a TKI. Issuance of this patent strengthens our clinical strategy as we move forward with the combination of Milciclib and a TKI for the clinical evaluation of advanced cases of HCC as well as in patients with recurrent HCC after liver transplantation."

    The person who arranged for the release of this announcement was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company

    Cited References:

    1. Villa, E., Piscaglia, F., Geva, R., Dalecos, G., Papatheodoridis, G., Ciomei, M., Davite, C., Crivori, P., Palejwala, V., Jacob, J., Hamzeh, F., Shailubhai, K., Santoro, A., and A., S. (2020) Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients. ASCO Abstract #29856



    2. Pivetti, A., Di Marco, L., Bristot, L., Milosa, F., Maria Critelli, R., De Maria, N., Di Benedetto, F., Palejwala, V., Jacob, J., Shailubhai, K., and Villa, E. (2020) Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence. ASCO Abstract #307309



    3. Jindal, A., Palejwala, V. a., and Shailubhai, K. (2018) Oral Treatment with Milciclib Either Alone or in Combination with Sorafenib Inhibited Tumor Growth in an Orthotopic Model of Hepatocellular Carcinoma. Hepatology 68, 879A

    About Milciclib (TZLS-201)

    Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signaling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies.  In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.  

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIM: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner
    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet
    + 44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry

    RedChip Companies Inc.

    407-491-4498

    Dave@redchip.com 

    Primary Logo

    View Full Article Hide Full Article
  50. -          Dr. Ferrara is the discoverer of Avastin® and Lucentis®, multi-billion dollars antibody drugs from Genentech

    -          A member of National Academy of Sciences and recipient of several prestigious awards, including the Lasker award.   

    NEW YORK and LONDON, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that Dr. Napoleone Ferrara, MD, Professor at the University of California San Diego Medical Center, has agreed to serve on its scientific advisory board (SAB) for an additional three year term.  Dr. Ferrara brings 30 plus years of experience…

    -          Dr. Ferrara is the discoverer of Avastin® and Lucentis®, multi-billion dollars antibody drugs from Genentech

    -          A member of National Academy of Sciences and recipient of several prestigious awards, including the Lasker award.   

    NEW YORK and LONDON, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that Dr. Napoleone Ferrara, MD, Professor at the University of California San Diego Medical Center, has agreed to serve on its scientific advisory board (SAB) for an additional three year term.  Dr. Ferrara brings 30 plus years of experience in clinical development of monoclonal antibodies (mAbs), which has been very useful in the formulation and clinical development of Foralumab, a fully human anti-CD3 mAb, as well as other immunotherapy projects.

    Dr. Ferrara is a member of The National Academy of Sciences and has received numerous prestigious awards, including the Lasker Award and the Breakthrough Prize in Life Sciences. His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the development and approval of humanized anti-VEGF mAbs (Bevacizumab; Avastin®) for cancer treatment. Dr. Ferrara also discovered that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. This pioneering research led to the clinical development of a humanized anti-VEGF Fab (Ranibizumab, Lucentis®), which has also been approved as a therapy for neovascular age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular edema. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders.

    Dr. Napoleone Ferrara stated: "I am excited to continue to serve on Tiziana's SAB as I believe that the immunotherapy pipeline of the company is highly innovative and conceptually very logical. The approaches to administer mAbs by oral and nasal routes to stimulate mucosal immune system to induce disease modifying benefits are like human physiological defense systems. Thus, these alternative routes of administration have potential to transform immunotherapies."

    "We are delighted to continue our relationship with Dr. Ferrara as he brings deep experience in the clinical development of immunotherapeutic drugs. We are in clinical development of oral and nasal administration of Foralumab, a fully human anti-CD3 mAb, for treatments of Crohn's Disease and progressive multiple sclerosis (pro-MS), respectively. Additionally, we are also developing inhalation administration of anti-IL-6 receptor (TZLS-501) mAb directly to the lungs for the treatment of COVID-19 patients. Dr. Ferrara's experience with mAbs will be extremely useful for us in the clinical development of our innovative mAb delivery approaches and for further development of our immunotherapy-based assets," commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

    The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About TZLS-501

    TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane.  The cytokine, IL-6, appears be a major determinant in the priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed as a soluble sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from which sIL-6R is implicated mediates pro-inflammatory effect underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, which is the major cause of lung damage, provides this mAb with distinct advantages for treatment of COVD-19.



    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder                                +44 (0)20 7495 2379

    Cairn Financial Advisers LLP (Nominated adviser)                +44 (0)20 7213 0880

    Liam Murray / Jo Turner

    Optiva Securities Limited (Broker)                                            +44 (0)20 3981 4173

    Robert Emmet

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com

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  51. NEW YORK and LONDON, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent on use and methods of treatment of Crohn's disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb). The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent will be published by the USPTO on 1 September, 2020 as Patent No. 10,759,858. Recently, Tiziana also…

    NEW YORK and LONDON, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent on use and methods of treatment of Crohn's disease with Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb). The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for the regulation of the immune system. The patent will be published by the USPTO on 1 September, 2020 as Patent No. 10,759,858. Recently, Tiziana also announced the issuance of the first-ever patent on oral administration of anti-CD3 mAbs for treatment of human diseases (Patent No. 10,688,186). The grant of this additional composition-of-matter and use patent further strengthens the Company's intellectual property, consisting of proprietary technologies on oral and nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of human diseases.

    Tiziana previously reported the successful completion of a Phase 1 trial utilizing oral administration of Foralumab on 9 January, 2020, which was designed to evaluate its safety and tolerability in healthy subjects. The trial was conducted at Brigham and Women's Hospital, Harvard Medical School, Boston, Mass., and indicated that oral administration of Foralumab was well-tolerated up to a 5 mg dose (https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers). The Company plans to move forward with a phase 2 trial in the 4th quarter of 2020 with orally administered Foralumab for the evaluation of moderate-to-severe patients with Crohn's Disease.

    Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Lifesciences, commented, "We are delighted that this key patent on composition-of-matter and use for treatment of Crohn's Disease is granted. We are very excited about the continued development of the oral administration of Foralumab for the treatment of Crohn's disease because this alternative route of administration seems to minimize toxicity and we believe it would maximize clinical activity by acting topically in the gut to inhibit inflammation."

    Additionally, Tiziana previously reported the successful completion of a Phase 1 study evaluating safety and analysis of biomarkers for clinical activity of nasally administered stabilized solution of Foralumab on 28 November, 2018 (https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers).

    Additionally, a Phase 2 trial in patients with progressive multiple sclerosis will commence in the 4th quarter. Importantly, in both clinical studies, the severe toxicities commonly associated with intravenous administration of anti-CD3 mAbs were not observed with oral or nasal administration of Foralumab.

    The person who arranged for the release of this announcement on behalf of the Company was Dr. Kunwar Shailubhai, CEO & CSO of Tiziana.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIM: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner
    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet
    +44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry

    RedChip Companies Inc.

    407-491-4498

    Dave@redchip.com

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  52. NEW YORK and LONDON, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, announced that members of its management team will participate virtually in the BTIG Biotechnology Conference on Tuesday, August 11, 2020 at 2:30 p.m. EDT. 

    To access a live webcast of the fireside chat please register for the BTIG Biotechnology Conference, using the link here. The investor presentation can be found on the Tiziana website, here. A replay of the webcast will be archived on Tiziana's website for approximately 45 days following the presentation.

    About Tiziana Life Sciences

    Tiziana Life Sciences…

    NEW YORK and LONDON, Aug. 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, announced that members of its management team will participate virtually in the BTIG Biotechnology Conference on Tuesday, August 11, 2020 at 2:30 p.m. EDT. 

    To access a live webcast of the fireside chat please register for the BTIG Biotechnology Conference, using the link here. The investor presentation can be found on the Tiziana website, here. A replay of the webcast will be archived on Tiziana's website for approximately 45 days following the presentation.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com

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  53. LONDON, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) (the "Company" or "Tiziana"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces the closing of its registered direct offering (the "Offering") of American Depositary Shares ("ADSs") on the NASDAQ Global Market. As announced on 3 August 2020, Tiziana issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares")) at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses). Each ADS offered represents two (2) Ordinary Shares…

    LONDON, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) (the "Company" or "Tiziana"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces the closing of its registered direct offering (the "Offering") of American Depositary Shares ("ADSs") on the NASDAQ Global Market. As announced on 3 August 2020, Tiziana issued 11,009,615 ADSs (representing 22,019,230 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares")) at a price of $5.20 per ADS raising gross proceeds of approximately $57.25 million (before deducting placement agent fees and offering expenses). Each ADS offered represents two (2) Ordinary Shares. All ADSs sold in the Offering were offered by the Company. The number of Ordinary Shares represented by ADSs comprised in the Offering were within existing shareholder authorities.

    ThinkEquity, a division of Fordham Financial Management, Inc., acted as the sole placement agent manager for the Offering.

    Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab, (ii) to initiate a trial in HCC patients with Milciclib, (iii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and for working capital and other general corporate purposes. Tiziana's Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc ("AIM"), under the symbol "TILS". The ADSs are listed for trading on the Nasdaq Global Market under the symbol "TLSA".

    This Offering was being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective on February 6, 2020.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A final prospectus supplement and accompanying base prospectus relating to this offering have been filed with the SEC and are available at the SEC's website at http://www.sec.gov.

    Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at prospectus@think-equity.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC's website at http://www.sec.gov.

    Total Voting Rights

    In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering, the total number of Ordinary Shares in issue is 190,559,823 There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

    The figure of 190,559,823 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules.

    The person who arranged for the release of this announcement on behalf of the Company was Keeren Shah, Chief Financial Officer of Tiziana.

    About Tiziana Life Sciences plc

    Tiziana Life Sciences is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. We believe Foralumab is the only fully human anti-CD3 mAb in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as NASH, primary biliary cholangitis (PBS), ulcerative colitis, MS, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    For readers in the European Economic Area

    In any member state in the European Economic Area (each, a "Member State"), this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Regulation. The term "Prospectus Regulation" means Regulation (EU) 2017/1129.

    For readers in the United Kingdom

    This announcement, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) ("Investment professionals") of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) ("High net worth companies, unincorporated associations etc.") of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs offered in the Offering are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

    For distributors

    Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the ADSs offered in the Offering have been subject to a product approval process, which has determined that the ADSs offered in the Offering are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the ADSs offered in the Offering may decline and investors could lose all or part of their investment; the ADSs offered in the Offering offer no guaranteed income and no capital protection; and an investment in the ADSs offered in the Offering is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering. Furthermore, it is noted that, notwithstanding the Target Market Assessment, ThinkEquity will only procure investors who meet the criteria of professional clients and eligible counterparties.

    For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to, the ADSs offered in the Offering.

    ThinkEquity, a division of Fordham Financial Management, Inc., is responsible for undertaking its own Target Market Assessment in respect of the ADSs offered in the Offering and determining appropriate distribution channels.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements including with respect to the creation of a trading market for ADSs representing the Ordinary Shares in the United States and the intended use of proceeds from the Offering. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements and include statements regarding the anticipated use of proceeds. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements including anticipated use of proceeds. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014

    NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

    For further enquiries:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
      
    ThinkEquity, a division of Fordham Financial Management, Inc.

    Ramnarain Jaigobind / Priyanka Mahajan
    (877) 436-3673
      
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 
    +44 (0)20 7213 0883

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    • Recently signed agreements with four contract research organizations ("CROs") to initiate GMP manufacturing, develop inhalation technology, conduct inhalation safety toxicity study in monkeys, and initiate a human clinical trial in COVID-19 patients

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced that it has signed agreements with four CROs to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R…

    • Recently signed agreements with four contract research organizations ("CROs") to initiate GMP manufacturing, develop inhalation technology, conduct inhalation safety toxicity study in monkeys, and initiate a human clinical trial in COVID-19 patients

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced that it has signed agreements with four CROs to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for the treatment of COVID-19 (SARS-CoV-2) patients. The Company intends to initiate the clinical study in Q1 2021 and will work with the following CROs:

    • FHI Clinical: A subsidiary of FHI 360, FHI Clinical is a multinational CRO specializing in clinical development of drugs for infectious diseases (https://www.fhiclinical.com). This company has conducted several recent trials in COVID-19 patients and has a large network of clinical sites throughout the US and abroad to expedite clinical trials with COVID-19 patients. In this trial, TZLS-501 will be delivered as an aerosol directly to the lungs using a hand-held nebulizer.
    • STC Biologics: STC Biologics, Inc. is a boutique Good Manufacturing Practice (GMP) CRO that provides full chemistry, manufacturing and control (CMC) services to enable its partners to advance their biologic products from discovery to commercial approval. GMP manufacturing of TZLS-501 is ongoing. 
    • Sciarra Labs: Sciarra Laboratories, Inc., is an FDA-approved, current GMP manufacturer of drug solutions used in nebulizers, inhalers, metered dose inhalers ("MDI") and nasal sprays. Tiziana worked with Sciarra Labs to establish clinical supply of nasal sprays of Foralumab used in the recently completed Phase 1. Sciarra Labs will be developing and testing a hand-held nebulizer and GMP manufacturing the anti-IL6R mAb solution to be used as clinical trial material for the clinical study in COVID-19 patients.
    • ITR Laboratories Canada: ITR has been in operation for the last 30 years and is known for its reputation in toxicology testing and other specialized testing services for biotechnology and pharmaceutical industries in North America, Europe and beyond. ITR is a Canadian Council on Animal Care (CCAC) and American Association for Accreditation of Laboratory Animal Care (AAALAC) CRO and is a fully compliant Good Laboratory Practices (GLP) CRO. ITR will be conducting safety and toxicity studies with TZLS-501 delivered by a nebulizer directly into the lungs of cynomolgus monkeys.

    Tiziana holds a worldwide exclusive license for TZLS-501 (a.k.a NI-1201) from Bristol Myers Squibb™. TZLS-501 is a novel fully human mAb that binds to both the membrane-bound and soluble forms of IL-6R and rapidly depletes circulating levels of IL-6 in the blood (1). Excessive production of IL-6 is regarded as a key driver of cytokine release syndrome (CRS) and chronic inflammation in the lungs of patients with COVID-19 and acute respiratory illness such as Acute Respiratory Distress Syndrome (ARDS). Tiziana's novel and proprietary approach to treatment is to deliver TZLS-501 directly to the lung via inhalation.

    Executive Chairman of Tiziana, Gabriele Cerrone, commented: "We have moved quickly to accelerate our clinical development plan for TZLS-501 using our innovative delivery platform, which was developed by Howard Weiner, a world-renowned neurologist and Chairman of our Scientific Advisory Board. I look forward to beginning our human clinical trials in the first quarter of 2021."

    Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "Our proprietary inhalation technology for delivery of TZLS-501 to the lungs in COVID-19 patients is an attractive and most logical approach to deplete excessive levels of IL-6 to provide rapid relief. We are focusing on the development of oral, nasal and inhalation routes of mAb administration for immunotherapy. The common underlying concept in these alternative delivery approaches is to enable local or topical actions to maximize clinical action and minimize undesirable side effects commonly associated with intravenous and subcutaneous administration. Being a fully human anti-IL-6 receptor mAb, TZLS-501 is most suitable for long-term immunotherapies."

    Cited Reference

    (1) Lacroix, M. et al., Novel Insights into Interleukin 6 (IL-6) Cis- and Trans-signaling Pathways by Differentially Manipulating the Assembly of the IL-6 signaling Complex. J Biol Chem. 2015 Nov 6; 290 (45): 26943-26953

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About TZLS-501

    TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα (IL-6R alpha) on the cell membrane. IL-6 appears be a major determinant in the priming of pathogenic T cells to produce an inflammatory response. The receptor IL-6Rα can be shed as a soluble entity, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex is believed to mediate the pro-inflammatory effects underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, a major cause of lung damage, suggests a potential role for TZLS-501 in the patient management and treatment of COVID-19.



    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder



    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet
    +44 (0)20 3981 4173

     

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com 

    Primary Logo

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  54. New York and London, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) (the "Company" or "Tiziana"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced it has entered into definitive agreements with investors for the purchase and sale of 11,009,615 of the Company's American Depositary Shares ("ADSs") at a price of $5.20 per ADS pursuant to a registered direct offering (the "Offering"). Each ADS offered represents two ordinary shares of nominal value £0.03  each ("Ordinary Shares"), following the recent forward split of the ADSs which became effective on 31 July 2020. The gross proceeds of the Offering will be approximately $57.25…

    New York and London, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) (the "Company" or "Tiziana"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced it has entered into definitive agreements with investors for the purchase and sale of 11,009,615 of the Company's American Depositary Shares ("ADSs") at a price of $5.20 per ADS pursuant to a registered direct offering (the "Offering"). Each ADS offered represents two ordinary shares of nominal value £0.03  each ("Ordinary Shares"), following the recent forward split of the ADSs which became effective on 31 July 2020. The gross proceeds of the Offering will be approximately $57.25 million, before deducting placement agent fees and other estimated offering expenses. The number of Ordinary Shares represented by ADSs comprised in the offering will be within existing shareholder authorities.

    ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole placement agent for the Offering.

    The closing of the Offering is expected to occur on August 5, 2020, subject to customary closing conditions.

    Application has been to made to admit the 22,019,230 Ordinary Shares to be issued in the Offering, in the form of ADSs, to trading on AIM. Admission is expected to become effective at 8.00 am on August 7, 2020.

    Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab, (ii) to initiate a trial in HCC patients with Milciclib, (iii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and for working capital and other general corporate purposes.

    Tiziana's Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc ("AIM"), under the symbol "TILS". The ADSs are listed for trading on the Nasdaq Global Market under the symbol "TLSA". Tiziana recently announced its intention to seek admission of its Ordinary Shares to the standard segment of the Official List and to trading on the Main Market of the London Stock Exchange plc to more closely align with its status as an international, cross-border issuer.

    This Offering is being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective on February 6, 2020.

    This announcement  shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A final prospectus supplement related to the Offering will  be filed with the SEC. For the avoidance of doubt these documents do not constitute a prospectus for the purposes of the UK Prospectus Regulation Rules and the documents will not be filed with, or reviewed by, the UK Financial Conduct Authority.

    Copies of the final prospectus supplement and accompanying prospectus relating to the Offering, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at prospectus@think-equity.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC's website at http://www.sec.gov.

    In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the total number of Ordinary Shares in issue will be 190,559,823.  There are no Ordinary Shares held in treasury.  Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

    The figure of 190,559,823 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules.

    Following admission of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the fully diluted issued share capital of the Company will consist of 211,252,494 Ordinary Shares.

    The person who arranged for the release of this announcement on behalf of the Company was Kunwar Shailubhai, CEO of Tiziana.

    About Tiziana Life Sciences plc

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For readers in the European Economic Area

    In any member state in the European Economic Area (each, a "Member State"), this announcement is only addressed to and directed at qualified investors in that Member State within the meaning of the Prospectus Regulation. The term "Prospectus Regulation" means Regulation (EU) 2017/1129.

    For readers in the United Kingdom

    This announcement, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at (i) persons who are outside the United Kingdom or (ii) persons who have professional experience in matters relating to investments who fall within Article 19(5) ("Investment professionals") of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (iii) certain high value persons and entities who fall within Article 49(2)(a) to (d) ("High net worth companies, unincorporated associations etc.") of the Order; or (iv) any other person to whom it may lawfully be communicated (all such persons in (i) to (iv) together being referred to as "relevant persons"). The ADSs offered in the Offering are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such ADSs will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

    For distributors

    Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the ADSs offered in the Offering have been subject to a product approval process, which has determined that the ADSs offered in the Offering are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the ADSs offered in the Offering may decline and investors could lose all or part of their investment; the ADSs offered in the Offering offer no guaranteed income and no capital protection; and an investment in the ADSs offered in the Offering is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering. Furthermore, it is noted that, notwithstanding the Target Market Assessment, ThinkEquity will only procure investors who meet the criteria of professional clients and eligible counterparties.

    For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to, the ADSs offered in the Offering.

    ThinkEquity, a division of Fordham Financial Management, Inc., is responsible for undertaking its own Target Market Assessment in respect of the ADSs offered in the Offering and determining appropriate distribution channels.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements including with respect to the creation of a trading market for ADSs representing the Ordinary Shares in the United States and the intended use of proceeds from the offering. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions.  Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements and include statements regarding the anticipated use of proceeds and the anticipated closing. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements including market conditions, whether the proposed offering is completed and the satisfaction of customary closing conditions related to the proposed offering. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    Tiziana Life Sciences plc 

    Gabriele Cerrone, Chairman and founder                                                      +44 (0)20 7493 2853                              

    ThinkEquity, a division of Fordham Financial Management, Inc.   

    Ramnarain Jaigobind / Priyanka Mahajan                                                              (877) 436-3673    

    Cairn Financial Advisers LLP (Nominated adviser)  

    Liam Murray / Jo Turner                                                                               +44 (0)20 7213 0883



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  55. LONDON and NEW YORK, July 31, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) (the "Company" or "Tiziana"), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today updated its total voting rights disclosure position.

    ATM Issues during July 2020

    During the calendar month of July, the Company issued a total of 2,043,000 ordinary shares under the Company's ATM sales agreement announced on 15 April 2020 to meet sales of a total of 408,600 ADSs under the ATM sales agreement, totaling gross proceeds of $4,371,289 in the month of July 2020. Those ordinary shares were admitted to trading on AIM under the Company's "US ADSs ATM Placing…

    LONDON and NEW YORK, July 31, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) (the "Company" or "Tiziana"), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today updated its total voting rights disclosure position.

    ATM Issues during July 2020

    During the calendar month of July, the Company issued a total of 2,043,000 ordinary shares under the Company's ATM sales agreement announced on 15 April 2020 to meet sales of a total of 408,600 ADSs under the ATM sales agreement, totaling gross proceeds of $4,371,289 in the month of July 2020. Those ordinary shares were admitted to trading on AIM under the Company's "US ADSs ATM Placing Scheme" block listing.

    Total Voting Rights

    In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares, the total number of Ordinary Shares in issue will be 168,540,593. There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

    The figure of 168,540,593 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    For further enquiries:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 



    +44 (0)20 7495 2379





    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 

     
    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet
    +44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com

     

    Primary Logo

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  56. NEW YORK and LONDON, July 31, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, is pleased to announce that it has submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies imply that a combination of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19 disease.

    • Nasal administration with Foralumab could potentially modulate or stimulate immune

    NEW YORK and LONDON, July 31, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, is pleased to announce that it has submitted a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19 either alone or in combination with other anti-viral drugs. Recent clinical studies imply that a combination of anti-inflammatory and anti-viral drugs may be more effective to treat patients at different stages of COVID-19 disease.

    • Nasal administration with Foralumab could potentially modulate or stimulate immune system to suppress cytokine storm and reduce respiratory failure in

      COVID-19 patients



    • Nasal administration of Foralumab may be combined with other anti-viral drugs to improve treatment efficacy

    Tiziana has a worldwide exclusive license for nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of neurodegenerative and other diseases. The Company previously announced development of a robust formulation and delivery of Foralumab using a nasal spray device and the successful completion of a Phase 1 trial demonstrating that the treatment was well-tolerated and showed positive immunomodulatory effects as measured by biomarker analysis (https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers).

    Additionally, Tiziana also reported the successful completion of a Phase 1 trial with oral administration of Foralumab, demonstrating that the treatment was well-tolerated up to a 5 mg dose (https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers). Importantly, both clinical studies conducted at the Brigham and Women's Hospital and Harvard Medical School, Boston, MA., indicated that the severe toxicities that are commonly associated with intravenous administration of anti-CD3 mAbs were not observed with either oral or nasal administration of Foralumab.

    "Nasal administration of Foralumab is a potentially transformative immunomodulatory approach for treating patients with a variety of human diseases. Results from animal studies conducted in our laboratory have established that nasal administration of anti-CD3 induces regulatory T cells that suppress inflammation and ameliorate diseases in animal models. This scientific advancement provides the basis to move forward with clinical development of nasally administered Foralumab in COVID-19 disease," commented Dr. Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital. He continued, "Modulating the immune system with nasal anti-CD3 is a first-in-class immunotherapeutic approach to treat COVID-19 disease."

    "Our proprietary immunotherapeutic approach using nasal, inhalation and oral administration of mAbs are novel and promising therapies that stimulate or modulate the immune system so that T regulatory cells (Tregs) are supercharged to inhibit inflammation. The common underlying concept in these alternative delivery approaches is to strengthen one's own body defense to fight against inflammation in these diseases. Being a fully human anti-CD3 mAb, we believe Foralumab is most suitable for immunotherapies, as it does not produce an immune response unlike other humanized anti-CD3 mAbs," commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
     



    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 



     
     



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



     



    United States:

    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
    +44 (0)20 3981 4173

     

    Primary Logo

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  57. NEW YORK and LONDON, July 30, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc the dual listed (NASDAQ:TLSA, UK AIMS:TILS))) today announces its intention to apply for admission to listing of its ordinary shares (the "Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority (the "Official List") and admission to trading on the London Stock Exchange plc's (the "London Stock Exchange") main market (the "Main Market") for listed securities (together, "Admission").

    The Company directors believe that a standard listing in conjunction with its NASDAQ dual listing will support the long-term strategy of the Company by providing the Company with a more appropriate platform for its growth as an international…

    NEW YORK and LONDON, July 30, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc the dual listed (NASDAQ:TLSA, UK AIMS:TILS))) today announces its intention to apply for admission to listing of its ordinary shares (the "Ordinary Shares") on the standard listing segment of the Official List of the Financial Conduct Authority (the "Official List") and admission to trading on the London Stock Exchange plc's (the "London Stock Exchange") main market (the "Main Market") for listed securities (together, "Admission").

    The Company directors believe that a standard listing in conjunction with its NASDAQ dual listing will support the long-term strategy of the Company by providing the Company with a more appropriate platform for its growth as an international company. In addition, the Company directors believe that Admission will raise the Company's global profile, increase its trading liquidity and provide the Company with a greater range of potential investors for its ordinary shares.

    Admission will be through an introduction of the existing Ordinary Shares. The Company will not be issuing new shares in conjunction with the proposed Admission or the publication of the related prospectus, and has no current intention to raise capital through the issue of new shares in the UK.

    Pursuant to Rule 41 of the AIM Rules for Companies, the Company will, in due course, give formal notice of the intended cancellation of trading of its Ordinary Shares on the AIM market of the London Stock Exchange ("AIM").

    It is expected that the Company will publish its prospectus in connection with Admission in late Q3 or early Q4 2020 and that the Ordinary Shares will be admitted to the Official List, commence trading on the Main Market and simultaneously trading will be cancelled on AIM (and at least 20 business days after the formal announcement under Rule 41 of the AIM Rules for Companies), subject to the receipt of the necessary approvals from the UK Listing Authority and the London Stock Exchange.

    The Company's shares will continue to be registered with their existing ISIN number GB00BKWNZY55. The Company's ticker symbol in the UK will continue to be TILS. The prospectus will, when issued, be made available on the Company's website at www.tizianalifesciences.com.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
     

    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 

     
     

    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet



    United States:



    Investors:

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com
    +44 (0)20 3981 4173

    Primary Logo

    View Full Article Hide Full Article
  58. NEW YORK and LONDON, July 30, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced that Kunwar Shailubhai, Ph.D., the Company's CEO and CSO, will share insight into Tiziana's development pipeline and upcoming milestones during an investor webinar, hosted by RedChip Companies, on Thursday, July 30, 2020 at 4:00 p.m. U.S. Eastern. A live Q&A session with Shailubhai will follow the presentation.

    To register for the free webinar, please visit: https://www.redchip.com/corporate/webinar_register/68

    About TZLS-501 (anti-IL-6R mAb) for COVID-19 Treatment
    TZLS-501, a fully human mAb…

    NEW YORK and LONDON, July 30, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced that Kunwar Shailubhai, Ph.D., the Company's CEO and CSO, will share insight into Tiziana's development pipeline and upcoming milestones during an investor webinar, hosted by RedChip Companies, on Thursday, July 30, 2020 at 4:00 p.m. U.S. Eastern. A live Q&A session with Shailubhai will follow the presentation.

    To register for the free webinar, please visit: https://www.redchip.com/corporate/webinar_register/68

    About TZLS-501 (anti-IL-6R mAb) for COVID-19 Treatment

    TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα (IL-6R alpha) can be shed as a soluble entity, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates the pro-inflammatory effects underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, a major cause of lung damage, suggests a potential role for TZLS-501 in patient management and treatment of COVID-19. The Company licensed TZLS-501 from Novimmune, a Swiss biotechnology company, in 2017.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    dave@redchip.com

    Primary Logo

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  59. LONDON and NEW YORK, July 24, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that it has allotted and issued 88,580 ordinary shares of 3 pence each ("New Ordinary Shares") credited as fully paid in respect of the exercise of 88,580 warrants at a price of 93 pence share, yielding £82,379 in cash proceeds for the Company. 

    Application has been made for the 88,580 New Ordinary Shares to be admitted to trading on AIM ("Admission"), and dealings are expected to commence on or around 30 July 2020. The New Ordinary Shares will rank pari passu with the Company's existing Ordinary…

    LONDON and NEW YORK, July 24, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces that it has allotted and issued 88,580 ordinary shares of 3 pence each ("New Ordinary Shares") credited as fully paid in respect of the exercise of 88,580 warrants at a price of 93 pence share, yielding £82,379 in cash proceeds for the Company. 

    Application has been made for the 88,580 New Ordinary Shares to be admitted to trading on AIM ("Admission"), and dealings are expected to commence on or around 30 July 2020. The New Ordinary Shares will rank pari passu with the Company's existing Ordinary Shares.

    Total Voting Rights

    In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the New Ordinary Shares to be issued in connection with the exercise of the warrants, the total number of Ordinary Shares in issue will be 166,497,593. There are no Ordinary Shares held in treasury. Each Ordinary Share entitles the holder to a single vote at general meetings of the Company.

    The figure of 166,497,593 Ordinary Shares may be used by shareholders (and others with notification obligations) as the denominator for the calculations by which they will determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Financial Conduct Authority's Disclosure Guidance and Transparency Rules.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to Milciclib, the Company will be shortly initiating phase 2 studies with orally administered Foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged the release of this information is Keeren Shah, Finance Director of Tiziana.

    For further enquiries: 
      
    United Kingdom: 
      
    Tiziana Life Sciences plc 
    Gabriele Cerrone, Chairman and founder+44 (0)20 7495 2379
      
    Cairn Financial Advisers LLP (Nominated adviser) 
    Liam Murray / Jo Turner +44 (0)20 7213 0880
      
    Optiva Securities Limited (Broker) 
    Robert Emmet+44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry

    RedChip Companies Inc.

    407 – 491 – 4498

    Dave@redchip.com

    Primary Logo

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  60. NEW YORK and LONDON, July 20, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, is pleased to announce the appointment of Mr. John Brancaccio to its Board as a Non-executive Director.

    Mr. Brancaccio, retired CPA, is a financial executive with extensive international and domestic experience in pharmaceutical and biotechnology for privately and publicly held companies. From 2000 to 2002, Mr. Brancaccio was the Chief Financial Officer/Chief Operating Officer of Eline Group, an entertainment and media company. From May 2002 until March 2004, Mr. Brancaccio was the Chief Financial…

    NEW YORK and LONDON, July 20, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, is pleased to announce the appointment of Mr. John Brancaccio to its Board as a Non-executive Director.

    Mr. Brancaccio, retired CPA, is a financial executive with extensive international and domestic experience in pharmaceutical and biotechnology for privately and publicly held companies. From 2000 to 2002, Mr. Brancaccio was the Chief Financial Officer/Chief Operating Officer of Eline Group, an entertainment and media company. From May 2002 until March 2004, Mr. Brancaccio was the Chief Financial Officer of Memory Pharmaceuticals Corp., a biotechnology company. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Officer of Accelerated Technologies, Inc., an incubator for medical device companies.

    Mr. Brancaccio is currently a director of Cardiff Oncology, Inc.,Rasna Therapeutics, Inc., OKYO Pharma LTD and Hepion Pharmaceuticals, Inc.

    Pursuant to Rule 17 and Schedule 2(g) of the AIM Rules for Companies, the following information is disclosed in respect of John Patrick Brancaccio (aged 72):

    Current AppointmentsAppointments in the last five years
    Cardiff Oncology, Inc.Synergy Pharmaceuticals, Inc.
    Hepion Pharmaceuticals, Inc. 
    Rasna Therapeutics, Inc.

    OKYO Pharma Ltd.
     

    There is no further information to be disclosed in relation to the appointments of Mr. Brancaccio pursuant to AIM Rule 17 and Schedule 2 (g) of the AIM Rules for Companies.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

     
      
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner
    +44 (0)20 7213 0880

     
      
    Optiva Securities Limited (Broker)

    Robert Emmet

    +44 (0)20 3981 4173

    Primary Logo

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  61. LONDON and NEW YORK, July 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) (the "Company" or "Tiziana"), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today announces that at the Annual General Meeting of the Company held at 10.00 a.m. on 16 July 2020, all of the resolutions were duly passed.

    The results of the proxy voting will be available shortly on the Company's website, www.tizianalifesciences.com.

    The person who arranged for the release of this announcement was Keeren Shah, Group Financial Controller.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a UK biotechnology company that focuses on…

    LONDON and NEW YORK, July 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) (the "Company" or "Tiziana"), a US and UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today announces that at the Annual General Meeting of the Company held at 10.00 a.m. on 16 July 2020, all of the resolutions were duly passed.

    The results of the proxy voting will be available shortly on the Company's website, www.tizianalifesciences.com.

    The person who arranged for the release of this announcement was Keeren Shah, Group Financial Controller.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to milciclib, the Company is also developing foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody known to the company in clinical development in the world. This compound has potential application in a wide range of autoimmune and inflammatory diseases, such as non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBS), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    The information contained in this announcement is inside information for the purposes of article 7 of regulation 596/2014

    For further enquiries:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379


    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 

     
     

    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet
    + 44 (0)20 3981 4173

     

    Primary Logo

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  62. NEW YORK and LONDON, July 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, is pleased to announce that it has submitted a patent application on potential use of Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to improve success of CAR-T therapy for cancer and other human diseases. The patent application conveys inventions related to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone or in combination with other co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific…

    NEW YORK and LONDON, July 16, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, is pleased to announce that it has submitted a patent application on potential use of Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), to improve success of CAR-T therapy for cancer and other human diseases. The patent application conveys inventions related to improving CAR-T expansion and/or survival using anti-CD-3 mAbs administered either alone or in combination with other co-stimulatory molecules, such as an anti-IL-6 receptor monoclonal antibody, an anti-CD28 monoclonal antibody or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).

    • Foralumab treatment could potentially enhance expansion and survival of chimeric antigen receptor T cells (CAR-T) therapy for cancers and other human diseases



    • Foralumab may be co-administered either alone or in combination with other drugs to improve success of CAR-T therapy

    "The CAR-T is one of the most promising therapies utilizing T cells from your own immune system, which are genetically engineered and supercharged to hunt down and destroy cancer cells. In this context, we are developing oral and nasal administrations of Foralumab for the treatment of Crohn's Disease and progressive multiple sclerosis, respectively. The common underlying approaches in these programs are to strengthen your own body defenses to fight against these diseases. Being a fully human anti-CD3 mAb, Foralumab is most suitable for CAR-T therapy as it does not produce an immune response unlike other humanized anti-CD3 mAbs," commented Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

    Typically, CAR-T cell therapies are created using a patients' own T cells that have been engineered to express a chimeric antigen receptor (CAR) to reprogram the T cells to kill cancer cells. The CAR combines the specificity of a mAb with the cytotoxic and memory functions of T cells. CAR-T cell therapy has shown tremendous promise in the treatment of a variety of hematological and solid cancers, and potentially for patients with autoimmune diseases. Despite encouraging clinical success, relapse rates following CAR-T therapy are high, limiting the utility of this promising cancer therapy. An improved CAR-T therapy can be achieved through more efficient production processes by optimizing the ex vivo expansion conditions and/or providing concomitant therapies utilizing anti-CD3 mAbs, either alone or in combination with other co-stimulatory molecules such as an anti-IL-6 receptor mAbs, an anti-CD28 mAbs or specific inhibitors of signaling pathways of phosphatidylinositol 3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR).

    This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014 ("MAR"), encompassing information relating to the Placing as described above, and is disclosed in accordance with the Company's obligations under Article 17 of MAR.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Exectuive Officer and Chief Scientific Officer of the Company.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs. 

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. 

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder                                +44 (0)20 7495 2379

    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner                                                        +44 (0)20 7213 0880

    Optiva Securities Limited (Broker)

    Robert Emmet                                                                      +44 (0)20 3981 4173

    United States:

    Investors

    Dave Gentry, CEO

    RedChip Companies Inc.

    407-491-4498

    Dave@redchip.com

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  63. NEW YORK and LONDON, July 15, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc ((", Tiziana", , AIM: TILS, NASDAQ:TLSA), announces a ratio change to its sponsored Level 3 American Depositary Receipt ("ADR") programme.

    Please note that pursuant to the announcement earlier today, to effect the change to the ADR ratio, ADR holders will receive 1.5 additional ADRs for every one (1) ADR held as of 27 July 2020, the ADR record date (and not 2.5 additional ADSs as previously stated).

    The timetable remains as previously stated.

    Existing ADRs will continue to be valid and will not have to be exchanged for new ADRs. In connection with this change, the register held by JPMorgan will be closed for issuances and cancellations from the close of business 27…

    NEW YORK and LONDON, July 15, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc ((", Tiziana", , AIM: TILS, NASDAQ:TLSA), announces a ratio change to its sponsored Level 3 American Depositary Receipt ("ADR") programme.

    Please note that pursuant to the announcement earlier today, to effect the change to the ADR ratio, ADR holders will receive 1.5 additional ADRs for every one (1) ADR held as of 27 July 2020, the ADR record date (and not 2.5 additional ADSs as previously stated).

    The timetable remains as previously stated.

    Existing ADRs will continue to be valid and will not have to be exchanged for new ADRs. In connection with this change, the register held by JPMorgan will be closed for issuances and cancellations from the close of business 27 July 2020 and will reopen on 04 August 2020.

    For further information, please contact:

    JPMorgan Service Centre ADR Settlements

    001 800-990-1135 or 001 302-552-0230

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 



    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 



    +44 (0)20 7213 0880
    Optiva Securities Limited (Broker)

    Robert Emmet
    + 44 (0)20 3981 4173

    Primary Logo

    View Full Article Hide Full Article
  64. NEW YORK and LONDON, July 15, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc ((", Tiziana", , AIM: TILS, NASDAQ:TLSA), announces a ratio change to its sponsored Level 3 American Depositary Receipt ("ADR") programme.

    This corporate action, which is a 2.5 for 1 forward split for the purposes of the NASDAQ listing, is equivalent to a share sub-division in the UK and will have the effect of increasing the number of ADSs in issue. It has no effect on the number of underlying shares in issue or the nominal value of the ordinary shares.

    The former ratio of five (5) ordinary shares to one (1) American Depositary Share ("ADS") has been changed to two (2) ordinary shares per one (1) ADS effective on 31 July 2020. There will be no change to the…

    NEW YORK and LONDON, July 15, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc ((", Tiziana", , AIM: TILS, NASDAQ:TLSA), announces a ratio change to its sponsored Level 3 American Depositary Receipt ("ADR") programme.

    This corporate action, which is a 2.5 for 1 forward split for the purposes of the NASDAQ listing, is equivalent to a share sub-division in the UK and will have the effect of increasing the number of ADSs in issue. It has no effect on the number of underlying shares in issue or the nominal value of the ordinary shares.

    The former ratio of five (5) ordinary shares to one (1) American Depositary Share ("ADS") has been changed to two (2) ordinary shares per one (1) ADS effective on 31 July 2020. There will be no change to the underlying ordinary shares.

    ADR record date:27 July 2020
    ADR payment date:30 July 2020
    ADR effective date:31 July 2020
    Symbol:TLSA
    Traded:NASDAQ
    CUSIP:88875G101
    Old Ratio:1 ADR: 5 ordinary shares
    New Ratio:1 ADR: 2 ordinary shares
    Underlying ISIN:GB00BKWNZY55
    Country of incorporation:United Kingdom
    Depositary:J.P. Morgan Chase Bank, N.A.
    Custodian:J.P. Morgan Chase Bank, London
      

    To effect this change, ADR holders will receive 2.5 additional ADRs for every one (1) ADR held as of 27 July 2020, the ADR record date. Existing ADRs will continue to be valid and will not have to be exchanged for new ADRs. In connection with this change, the register held by JPMorgan has been closed for issuances and cancellations from the close of business 27 July 2020 and will reopen on 04 August 2020.

    For further information, please contact:

    JPMorgan Service Centre ADR Settlements

    001 800-990-1135 or 001 302-552-0230

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    For further enquiries:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379


    Cairn Financial Advisers LLP (Nominated adviser)


    Liam Murray / Jo Turner 

     

    +44 (0)20 7213 0880


    Optiva Securities Limited (Broker)


    Robert Emmet


    + 44 (0)20 3981 4173

    Primary Logo

    View Full Article Hide Full Article
  65. NEW YORK and LONDON, July 10, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announced an interview with Kunwar Shailubhai, Ph.D., the Company's CEO and CSO, will air on The RedChip Money Report television program. The interview will air Sunday, July 12, at 3 p.m. local time on Bloomberg International, available in 100+ million homes across Europe.

    In the exclusive interview, Dr. Shailubhai provides insight into Tiziana's development pipeline and upcoming milestones.

    To view the interview segment, please visit: https://youtu.be/ggFJ-XX6C5M

    The interview will also air…

    NEW YORK and LONDON, July 10, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announced an interview with Kunwar Shailubhai, Ph.D., the Company's CEO and CSO, will air on The RedChip Money Report television program. The interview will air Sunday, July 12, at 3 p.m. local time on Bloomberg International, available in 100+ million homes across Europe.

    In the exclusive interview, Dr. Shailubhai provides insight into Tiziana's development pipeline and upcoming milestones.

    To view the interview segment, please visit: https://youtu.be/ggFJ-XX6C5M

    The interview will also air in the US on the Action Channel on Sunday, July 12 at 11 a.m. and on My Family TV on Wednesday, July 15 at 6 p.m. and is available via live stream on American Business TV.

    "The RedChip Money Report" delivers insightful commentary on small-cap investing, interviews with Wall Street analysts, financial book reviews, as well as featured interviews with executives of public companies.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    Forward Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    Tiziana Life Sciences plc:

    Gabriele Cerrone, Chairman and founder

    +44 (0)20 7495 2379

    Investor Contact:

    RedChip Companies, Inc.

    Dave Gentry

    407-491-4498

    dave@redchip.com

    Primary Logo

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  66. NEW YORK and LONDON, June 29, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces the execution of an agreement with STC Biologics, Inc. ("STC") for GMP manufacturing of TZLS-501, an anti-IL-6 receptor (anti-IL-6R) monoclonal antibody (mAb) acquired from Novimmune in 2017, currently in agreement with Bristol Myers Squibb (BMS).

    Tiziana is simultaneously developing an inhalation technology, in collaboration with Sciarra Laboratories, for the direct delivery of TZLS-501 into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19. The proprietary…

    NEW YORK and LONDON, June 29, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces the execution of an agreement with STC Biologics, Inc. ("STC") for GMP manufacturing of TZLS-501, an anti-IL-6 receptor (anti-IL-6R) monoclonal antibody (mAb) acquired from Novimmune in 2017, currently in agreement with Bristol Myers Squibb (BMS).

    Tiziana is simultaneously developing an inhalation technology, in collaboration with Sciarra Laboratories, for the direct delivery of TZLS-501 into the lungs using a handheld inhaler or nebulizer for treatment of patients with COVID-19. The proprietary novel technology to administer TZLS-501 directly into the nasal passages or lungs by inhaler or nebulizer has potentially significant clinical advantages for the treatment of COVID-19 patients.

    The Company recently submitted a patent application for the inhalation delivery of anti-IL6R-monoclonal antibody for the treatment of COVID-19.

    TZLS-501, a unique and best-in-class anti-IL-6R mAb, follows a dual mechanism by not only blocking downstream signaling pathways from membrane-bound and soluble IL-6 receptors, but it also rapidly depletes blood-stream levels of IL-6, the major culprit for cytokine release syndrome (CRS) in lungs of COVID-19 patients. In receptor binding assays, TZLS-501 is considerably more potent than the other anti-IL-6R mAb in this class, such as Actemra® (Roche)1,2. These biochemical features, differentiating TZLS-501 from other mAbs in this class, offer potential distinctive clinical advantages in effecting a rapid suppression of the cytokine storm at much lower doses.

    The proprietary inhalation technology for direct delivery of mAbs or other small molecule drugs such as Remdesivir® (Roche) to lungs could potentially be a transformational therapy for developing a rapid treatment of COVID-19

    "We are aggressively advancing GMP manufacturing of TZLS-501 concurrently with the development of inhalation technology using a hand-held nebulizer and safety toxicology studies in cynomolgus monkeys. Our objective is to submit an Investigational New Drug (IND) Application in the first quarter of 2021 for the treatment of COVID-19 patients," said Kunwar Shailubhai, Ph.D., CEO and CSO of Tiziana Life Sciences.

    "The initiation of GMP manufacturing of TZLS-501 with STC is a timely step forward toward expediting development of a potentially innovative treatment for COVID-19 patients. We are very excited and well positioned to accelerate the development of TZLS-501 for COVID-19 patients in such extraordinary times," added Dr. Magdalena Leszczyniecka, President and CEO of STC Biologics. "Our state-of-the-art single use production facility, highly cross-trained experienced personnel, and nimble decision-making has provided unprecedented speed to clinic in prior GMP campaigns. Together with a strong track record of pharmaceutical, regulatory and process development know-how, we are uniquely positioned to advance TZLS-501 to the clinic."

    Sciarra Laboratories, Inc., has been developing and manufacturing pharmaceutical aerosol products for over 25 years. Previously, Sciarra worked with Tiziana to successfully manufacture clinical supplies for the nasal administration of Foralumab, a fully human anti-CD3 mAb, for the recently completed Phase 1 trial3, and the company is currently working with Tiziana to manufacture Foralumab for nasal administration using a medical device, which will also be used for the upcoming Phase 2 trial in progressive multiple sclerosis. This phase 2 trial will commence shortly at the Brigham and Women's Hospital, Harvard Medical School, Boston, MA.

    Cited References

    1. Lacroix, M. et al., Novel Insights into Interleukin 6 (IL-6) Cis- and Trans-signaling Pathways by Differentially Manipulating the Assembly of the IL-6 Signaling Complex. J Biol Chem. 2015 Nov 6; 290(45): 26943–26953.



    2. Chaolin Huang, MD., et al., Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. The Lancet, volume 395, pages 497-506. 2020. Published January 24, 2020.

       
    3. Tiziana Lifesciences Press Release: https://www.tizianalifesciences.com/news-item?s=2019-09-10-tiziana-reports-phase-1-clinical-data-demonstrating-nasal-treatment-with-foralumab-was-well-tolerated-and-produced-positive-trend-in-biomarkers-of-immunomodulation-and-anti-inflammation-in-healthy-volunteers

    About TZLS-501 (anti-IL-6R mAb)

    TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα (IL-6R alpha) can be shed as a soluble entity, sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates the pro-inflammatory effects underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, a major cause of lung damage, suggests a potential role for TZLS-501 in patient management and treatment of COVD-19. The Company licensed TZLS-501 from Novimmune, a Swiss biotechnology company, in 2017.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    About STC Biologics, Inc.

    STC Biologics, Inc. is a boutique biologics CDMO located in Newton, MA that provides full CMC services to enable its partners advance their biologic products from discovery to commercial approval. Founded in 2009, STC has established its reputation as a flexible organization that clients can turn to for accelerated low cost programs or custom development when template processes don't work. STC's new 4000 sq ft state-of-the-art, single-use manufacturing suites and a second smaller clean room suite provides flexibility and cost saving for clients with vastly different product demands. STC's team brings 100+ years of collective expertise in biologics drug development from global biopharmaceutical companies. The cross-training of its scientists in diverse fields with integration of biology and regulatory sciences into process development is what makes STC unique in its ability to efficiently develop complex biological products. STC Biologics strives to realize "Speed to Clinic" through integrated product development, technical rigor, and flexibility.

    About Sciarra Laboratories

    Sciarra Laboratories, Inc., has been a leader in the development of aerosol pharmaceutical products since 1957 and has been developing and manufacturing pharmaceutical aerosol products at its FDA-approved, cGMP manufacturing facility located in Hicksville, New York since 1991. Its product line ranges from topical foams, gels, and sprays to metered dose inhalers (MDI) and nasal sprays. Sciarra manufactures OTC, NDA and medical device products. Sciarra has developed over 50 formulations. Sciarra offers a turnkey operation from development, validation, and manufacturing services.

    Forward-Looking Statements

    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    For further enquiries:

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7493 2379
      
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    • First-ever granted patent on oral administration of anti-CD3 monoclonal antibodies for immunotherapies
    • Transformational oral formulation technologies applicable to other antibodies

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, June 19, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent covering its proprietary platform technology for the oral administration of Foralumab, its proprietary fully human monoclonal…

    • First-ever granted patent on oral administration of anti-CD3 monoclonal antibodies for immunotherapies

    • Transformational oral formulation technologies applicable to other antibodies

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, June 19, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS))) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the United States Patent and Trademark Office ("USPTO") has granted a patent covering its proprietary platform technology for the oral administration of Foralumab, its proprietary fully human monoclonal antibody, and all other anti-CD3 monoclonal antibodies (mAb). The CD3 (cluster of differentiation 3) is a protein complex on T-cells, which is important for regulation of immune system. The patent will be issued by the USPTO on 23 June 2020.

    "The issuance of this first-ever patent on formulation for oral administration of mAbs is a very exciting and timely development, as it facilitates a transformational avenue for immunotherapies," commented Dr. Howard L. Weiner, Chairman of Tiziana's Scientific Advisory Board, Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham and Women's Hospital. "We also recently successfully demonstrated that nasally-administered Foralumab is not only well tolerated but also produced desirable immunological responses. In addition, both oral and nasal administration routes are physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits, while minimizing the severe toxicities commonly associated with the traditional intravenous administration of anti-CD3 mAbs."

    "The granting of this patent on first-in-class formulation technology allows us to work on bringing patients the first non-intravenous or subcutaneous treatment with antibodies to treat major gastrointestinal and neurodegenerative diseases such as Crohn's Disease, pro-MS and Alzheimer's disease. We believe development of the alternative administration routes of antibodies such as oral, nasal and inhalation could potentially be transformational for immunotherapies," added Gabriele Cerrone, chairman and founder of Tiziana.

    The patent titled "Anti-CD3 formulations; patent No. 10,688,186, Inventor: Kunwar Shailubhai", is the first-ever to be granted on anti-CD3 formulations and covers oral administration with lyophilized and stabilized free-flowing powder of Foralumab or any other anti-CD3 mAb, encapsulated in enteric-coated capsules, for treatment of human diseases. In addition, the stabilized liquid formulation of Foralumab and other anti-CD3 mAbs for nasal administration is also covered in this patent. These formulation technologies have the potential to transform immunotherapies, which currently can only be administered through intravenously or subcutaneously.

    Tiziana previously reported the successful completion of a Phase 1 trial utilizing oral administration of Foralumab, which was designed to evaluate its safety and tolerability in healthy subjects. The trial was conducted at Brigham and Women's Hospital, Harvard Medical School, Boston, Mass., and indicated that oral administration of Foralumab was well tolerated up to a 5 mg dose (https://www.tizianalifesciences.com/news-item?s=2020-01-09-tiziana-reports-phase-1-clinical-data-demonstrating-oral-treatment-with-foralumab-a-fully-human-anti-cd3-monoclonal-antibody-is-well-tolerated-in-healthy-volunteers). The Company plans to move forward with further development of orally administered Foralumab for evaluation in moderate-to-severe patients with Crohn's Disease. Additionally, Tiziana previously reported the successful completion of a Phase 1 study evaluating safety and analysis of biomarkers for clinical activity of nasally administered stabilized solution of Foralumab (https://www.tizianalifesciences.com/news-item?s=2018-11-28-tiziana-announces-initiation-of-phase-1-clinical-trial-with-nasal-administration-of-foralumab-a-fully-human-anti-cluster-definition-3-monoclonal-antibody-anti-cd3-mab-in-healthy-volunteers). A Phase 2 trial in patients with progressive multiple sclerosis will commence shortly. Importantly, in both clinical studies, the severe toxicities commonly associated with intravenous administration of anti-CD3 mAbs were not observed with oral or nasal administration of Foralumab.

    The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, CEO & CSO of Tiziana.

    About Foralumab

    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIM: TILS))) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The Company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    For further enquiries: 

    United Kingdom:

    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7493 2379
     



    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner 



     
     



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  67. LONDON and NEW YORK, June 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), the U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, announces Gregor MacRae is standing down as a director of the Company with immediate effect.

    Gabriele Cerrone, Chairman of Tiziana, said "I thank Gregor for his contribution to the Board and the Company and wish him well in his other interests. We are currently in the process of recruiting a new, seasoned non-executive director with extensive NASDAQ audit committee experience and hope to make a formal announcement shortly".

    This announcement contains inside…

    LONDON and NEW YORK, June 18, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), the U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, announces Gregor MacRae is standing down as a director of the Company with immediate effect.

    Gabriele Cerrone, Chairman of Tiziana, said "I thank Gregor for his contribution to the Board and the Company and wish him well in his other interests. We are currently in the process of recruiting a new, seasoned non-executive director with extensive NASDAQ audit committee experience and hope to make a formal announcement shortly".

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    Contacts:

    For further enquiries: 

    United Kingdom: 
    Tiziana Life Sciences plc

    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7493 2379
      
    Cairn Financial Advisers LLP (Nominated adviser)

    Liam Murray / Jo Turner

    +44 (0)20 7213 0880
      
    Optiva Securities Limited (Broker)

    Robert Emmet
    + 44 (0)20 3981 4173
      

    United States:

    Investors -

    CORE IR

    (516) 222-2560

    ir@coreir.com

    Media

    Jules Abraham

    CORE IR

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    For more information go to http://www.tizianalifesciences.com

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  68. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, June 04, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the Chairman of the Company's Scientific Advisory Board, Dr. Howard Weiner, has received a competitive research grant from the National Institutes of Health (NIH) to investigate nasal anti-CD3 for the treatment of Alzheimer's disease.

    The demonstration that nasally administered anti-CD3 retards disease processes underlying the progression of Alzheimer's disease in animal models, further expands clinical development of nasally…

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, June 04, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces that the Chairman of the Company's Scientific Advisory Board, Dr. Howard Weiner, has received a competitive research grant from the National Institutes of Health (NIH) to investigate nasal anti-CD3 for the treatment of Alzheimer's disease.

    The demonstration that nasally administered anti-CD3 retards disease processes underlying the progression of Alzheimer's disease in animal models, further expands clinical development of nasally administered Foralumab, the only entirely human anti-CD3 monoclonal antibody, for the potential treatment of Alzheimer's and other neurodegerative diseases in humans.

    The Company has a worldwide exclusive license for nasal administration of anti-CD3 mAbs for treatment of neurodegenerative diseases, including Alzheimer's disease, from Brigham and Women's Hospital, Harvard Medical School, Boston. To date the Company has successfully completed two phase 1 trials and intends to initiate two phase 2 trials with nasally and orally administered Foralumab shortly for treatment of progressive multiple sclerosis (pro-MS) and Crohn's disease, respectively.

    "Nasal administration of Foralumab is a potentially revolutionary approach to treat patients with Alzheimer's disease. Preclinical animal studies have established that nasal administration of anti-CD3 can modulate brain microglia and ameliorate disease in animal models. This is a major scientific advancement that provides the basis to move forward with clinical development of nasally administered Foralumab in Alzheimer's disease," commented Dr. Weiner, who is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis Center and Co-Director of the Ann Romney Center for Neurologic Diseases at the Brigham & Women's Hospital. "Targeting microglia with nasal anti-CD3 is a first-in-class immunotherapeutic approach to treat Alzheimer's disease."

    Alzheimer's disease is the most common cause of dementia, which affects millions of people worldwide. It is now recognized that brain microglia have a critical role in Alzheimer's disease. In an unexpected discovery, Dr. Weiner found that nasal anti-CD3 modulates brain microglia in animal models. Treatment with anti-CD3 is known to stimulate T regulatory (Tregs) cells, which have the ability to cross the blood-brain barrier (1) The effect of nasal anti-CD3 in dampening microglial activation led Dr. Weiner's team at the Ann Romney Center for Neurologic Diseases at Brigham and Women's Medical Center to evaluate nasally administered Foralumab for pro-MS (2). In 2019, Dr. Weiner successfully completed a Phase 1 study with nasally administered Foralumab in healthy volunteers in a dose-ranging trial. A subsequent Phase 2 trial in patients with pro-MS will be initiated shortly.

    "Alzheimer's disease is considered to be the disease of the century, presenting multiple challenges and limited therapeutic successes so far," added Gabriele Cerrone, Chairman and Founder of Tiziana Life Sciences. "For this reason, combined with Dr. Weiner's expertise and the encouragement by the NIH to explore it, we are excited to further expand our proprietary novel approach to treat neurodegerative diseases with nasal administration of Foralumab, a first-in-class approach that has shown retardation of Alzheimer's disease progression in preclinical models."

    Sources

    (1) Ogura M, et al. Oral treatment with foralumab, a fully human anti-CD3 monoclonal antibody, prevents skin xenograft rejection in humanized mice. Clin Immunol. 2017 Oct;183:240-246.  doi: 10.1016/j.clim.2017.07.005. Epub 2017 Jul 21.
       
    (2) Mayo, L. et al. IL-10-dependent TrI cells attenuate astrocyte activation and ameliorate chronic central nervous system inflammation. Brain. 2016: 139; 1939-1957.

    About Dr. Howard Weiner
    Dr. Howard L. Weiner is the Robert L. Kroc Professor of Neurology at the Harvard Medical School, Director and Founder of the Partners Multiple Sclerosis (MS) Center and Co-Director of the Ann Romney Center for Neurologic Diseases at Brigham & Women's Hospital in Boston. He has pioneered immunotherapy in MS and has investigated immune mechanisms in nervous system diseases including MS, Alzheimer's disease, amyotrophic lateral sclerosis, stroke and brain tumors. He has also pioneered the investigation of the mucosal immune system for the treatment of autoimmune and other diseases and the use of anti-CD3 to induce regulatory T-cells (Tregs) for the treatment of these diseases.

    About Neurodegenerative diseases
    Neurodegenerative diseases include Alzheimer's, progressive multiple sclerosis, Huntington's disease, Parkinson's disease, ALS and others. Among these, Alzheimer's is the most prevalent disease. In 2013 the global market for AD was $4.9 billion and expected to rise to $13 billion by the end of 2023. Current treatments for neurodegenerative diseases are mainly symptomatic, but new disease-modifying drugs to slow or stop the progression of the disease are now emerging. Three Acetylcholinesterase inhibitors are currently in use for AD, i.e. donepezil (Aricept), rivastigmine (Exelon) and galantamine (Reminyl). It is recognized that localized CNS inflammation plays a critical role in neurodegenerative diseases of the brain. Immune-directed therapies for neurodegenerative diseases that target localized CNS microglial inflammation show promise. It has been shown in animal models of progressive MS that anti-CD3 antibody targeting T cells ameliorates disease. These effects were shown to be IL-10 dependent, mediated by regulatory T cells leading to suppression of the disease. There is great promise in ongoing studies of inflammation-targeted neuroprotective strategies, which may ultimately be used across neurodegenerative diseases.

    About Foralumab
    Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines after IV administration in patients with Crohn's disease with decreases in the classic side effects of cytokine release syndrome (CRS) and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS)) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of hospitalized COVID-19 patients with severe respiratory symptoms.

    The person who arranged for the release of this information was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

    Contacts:  
    Tiziana Life Sciences plc  
    United Kingdom:  
    Gabriele Cerrone, Chairman and founder 

    +44 (0)20 7493 2379
    Cairn Financial Advisers LLP (Nominated adviser)
    Liam Murray / Jo Turner 

    +44 (0)20 7213 0883

    Optiva Securities Limited (Broker)
    Robert Emmet
    + 44 (0)20 3981 4173

    United States:
    Investors
    CORE IR
    ir@coreir.com 

    Media
    Jules Abraham
    CORE IR
    (917) 885-7378
    julesa@coreir.com 

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    • StemPrintER Outperforms Oncotype DX in analysis with 800+ samples from ER+/HER2- postmenopausal breast cancer patients
    • SPARE Model is up to 40-50% more accurate than standard clinical markers in analysis with 1800+ samples for prediction of distant metastasis

    NEW YORK and LONDON, May 29, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today results, from a poster selected for discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference, demonstrating the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader…

    • StemPrintER Outperforms Oncotype DX in analysis with 800+ samples from ER+/HER2- postmenopausal breast cancer patients
    • SPARE Model is up to 40-50% more accurate than standard clinical markers in analysis with 1800+ samples for prediction of distant metastasis

    NEW YORK and LONDON, May 29, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today results, from a poster selected for discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference, demonstrating the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast cancer patients. A second poster describing results on prediction of distant recurrence using a next generation StemPrintER model, named SPARE, presented in a separate ASCO session, showed even more refined accuracy than standard clinicopathological markers in predicting risk of distant recurrence. Both posters were authored by a team of scientists from the European Institute of Oncology in Milan, and the head-to-head comparison of StemPrintER with Oncotype DX was conducted in collaboration with the Royal Marsden Hospital and Queen Mary University in London.

    As announced previously, the Company intends to demerge its StemPrintER and SPARE (together "StemPrintER") genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity.

    Major Highlights of Results

    1. The first poster, which was also part of a discussion session, "Comparison of StemPrintER, a Novel Biology-based Genomic Predictor of Distant Recurrence in Breast Cancer, with Oncotype DX in the TransATAC cohort," shows that StemPrintER


      • Outperforms Oncotype DX in 10-year risk prediction in more than 800 ER+/HER2- postmenopausal breast cancer patients in the analysis, including in lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients1.
      • Significantly (p<0.0001) stratifies high vs. low risk groups when adjusted for clinical parameters as expressed by clinical treatment scores (CTS).

    2. The second poster, "Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer patients," demonstrates that the next-generation StemPrintER Risk Score (SPARE) model
       
      • Shows approximately 20% superiority to the traditional clinicopathological parameters, as expressed by the CTS, in providing prognostic information for the more than 1,800 patients analyzed and in certain populations was demonstrated to be up to 40-50% more accurate.
      • Investigators found that SPARE added substantial prognostic information to CTS, but the inverse was not proven to be the case.

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this information is Dr Kunwar Shailubhai, the Company's Chief Executive Officer and Chief Scientific Officer.

    About ER+/Her2- breast cancer
    Endocrine receptor-positive (ER+) breast cancers constitute the majority of breast cancer cases (~75-80%) and display remarkable variability in clinical behaviour. This heterogeneity makes prognosis and therapy response often challenging to predict using the standard clinicopathological features of the tumor. Although the overall prognosis for this group of patients is good, a significant proportion (>20%) of these women will experience distant recurrence in the first 10 years post-surgery. For ER+ patients who also have a negative HER2 status (HER2-), the standard of care is endocrine therapy with the addition of adjuvant chemotherapy in those patients considered to be at risk of recurrence according to clinicopathological parameters. However, it has become apparent that these parameters are often insufficient to predict risk of recurrence in ER+/HER2- BC patients, and, as a consequence, a significant proportion of these patients are either over- or under-treated. Multigene prognostic tests can assist decision making on treatments, differentiating low risk patients who could be safely SPARE chemotherapy from higher risk patients who might benefit from chemotherapy.

    About StemPrintER/SPARE
    StemPrintER, and its next generation derivative SPARE that combines StemPrintER with two clinical markers, namely lymph nodal status and tumor size, in a more refined risk model, is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, ER+/HER2- breast cancer patients, based on the detection of 20 cancer stem cell markers normalized to 4 housekeeping genes. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS)) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.

    Forward-Looking Statements
    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    Contacts:
    Tiziana Life Sciences plc
    United Kingdom:
    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379

    Cairn Financial Advisers LLP (Nominated adviser)
    Liam Murray / Jo Turner
    + 44 (0)20 7213 0883

    Shore Capital (Broker)
    Antonio Bossi / Fiona Conroy
    +44 (0)20 7601 6125

    United States:
    Investors
    CORE IR
    ir@coreir.com

    Media
    Jules Abraham
    CORE IR
    (917) 885-7378
    julesa@coreir.com

    1 N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) might describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.

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  69. NEW YORK and LONDON, May 22, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS)), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces that it intends to demerge its StemPrintER and SPARE (together "StemPrintER") genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity. 

    Following the Company's recent announcement concerning the trial conducted by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company's stem cell biology-based…

    NEW YORK and LONDON, May 22, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS)), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces that it intends to demerge its StemPrintER and SPARE (together "StemPrintER") genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity. 

    Following the Company's recent announcement concerning the trial conducted by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company's stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, the Company's Board, which has been considering options for StemPrintER for some time, is pleased to announce that they consider that the results of the trial and the progress made substantiate the viability of StemPrintER as having the potential to be a standalone business and accordingly intend to proceed with steps for a spin-out, by way of demerger, and listing on a public market of a new independent genomics-based personalized medicine company focused on the StemPrintER business.

    The rationale of this decision is that, as a standalone genomics-based personalized medicine company and separate legal entity, StemPrintER could:

    • Secure separate financial resources, with the goal of enabling accelerated development of the StemPrintER genomic test;
       
    • Separate StemPrintER from Tiziana's biotechnology and pharmaceutical businesses so it may focus on the personalized medicine market; and
       
    • Allow Shareholders to benefit from both Tiziana's rapidly developing drug portfolio and the standalone value of StemPrintER as it progresses through its own development milestones and the path to commercialization and allow shareholders to receive the maximum potential value from StemPrintER as a standalone entity.

    The Board is taking the necessary preliminary steps in preparation for a potential spin-out, including the incorporation of a new subsidiary to hold the relevant assets. The Company will also put proposals to shareholders at the Annual General Meeting to obtain the approval necessary for a capital reduction which will be required to implement the demerger.

    Notwithstanding that the required approval for the capital reduction will be sought, these considerations remain at an early stage and there can be no guarantee that the demerger will be completed. The approval of the capital reduction will enable the Board, in due course, to declare distribution in specie of shares in the new StemPrintER entity to existing Tiziana shareholders.

    No record date has yet been set for the entitlement to shares in the new StemPrintER entity as a number of technical, legal and accounting processes need to be completed before the demerger can be formally put to shareholders of Tiziana for approval. For the avoidance of doubt StemPrintER will remain a group business until such time as shareholders formally approve proposals for a demerger.

    For shareholder interest and information, StemPrintER will be the subject of a poster discussion session (https://meetinglibrary.asco.org/record/185144/abstract) on 29 May 2020 titled "Comparison of StemPrintER, a novel stem cell biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort" at the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).

    Further announcements will be made at the appropriate time.

    About StemPrintER and SPARE

    StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.

    For more information go to http://www.tizianalifesciences.com

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    THE PERSON WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY'S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.

    Contacts:
    Tiziana Life Sciences plc
    United Kingdom:

    Tiziana Life Sciences plc
    Gabriele Cerrone, Chairman and founder
    +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)
    Liam Murray / Jo Turner
    +44 (0)20 7213 0883
       
    Shore Capital (Broker)
    Antonio Bossi / Fiona Conroy
    +44 (0)20 7601 6125

    United States:
    Investors -
    CORE IR
    (516) 222-2560
    ir@coreir.com

    Media -
    Jules Abraham
    CORE IR
    (917) 885-7378
    julesa@coreir.com

     

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  70. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, May 14, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS)) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces the online publication of two abstracts on clinical studies with Milciclib, a small molecule pan-inhibitor of cyclin dependent kinases (CDKs) in the proceedings of the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).
     
    The first abstract reports Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC…

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, May 14, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA, AIM: TILS)) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announces the online publication of two abstracts on clinical studies with Milciclib, a small molecule pan-inhibitor of cyclin dependent kinases (CDKs) in the proceedings of the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).
     
    The first abstract reports Phase 2a clinical data with orally administered Milciclib in sorafenib-resistant hepatocellular carcinoma (HCC) patients, for which it met the primary endpoint, that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug-related deaths. The second abstract reports preliminary clinical data from an ongoing investigator-originated trial with a combination of orally administered Milciclib and Regorafenib in liver transplant patients with recurrent HCC. Thus far, the study has shown mean AFP levels (a common tumor biomarker) reduced by approximately 20% within one month of treatment.

    MAJOR HIGHLIGHTS

    Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients. First Author: Erica Villa, MD., et al.

    • Phase 2a multi-centered clinical evaluation of Milciclib (100 mg once daily; 4 days on/3 days off for 4 weeks; defining each cycle) for 6-month in 28 evaluable out of 31 enrolled patients in Italy, Greece and Israel.

    • The trial successfully met the primary endpoint that oral treatment with Milciclib was well tolerated with manageable toxicities and no recorded drug related deaths.

    • The secondary endpoints for clinical activity assessment were based on the independent radiological review using the modified Response Evaluation Criteria in Solid Tumors (mRECIST)

    • Positive demonstrated clinical activity included:
       
      1. 50% (14 out of 28) evaluable patients completed 6-month duration of the trial.

      2. 64% (9 out of 14) patients requested and were approved by their respective ethical committees to continue the treatment.

      3. Both median time to progression (TTP) and progression free survival (PFS) were 5.9 months (95% Confidence Interval ("CI") 1.5-6.7 months) out of the 6-months duration of the trial.

      4. Approximately 57% of evaluable patients showed 'Stable Disease' (SD; met at least once in an 8-week interval) and 3.6% patients showed 'Partial Response' (PR).

      5. Approximately 61% of patients showed 'Clinical Benefit Rate' defined as CBR=CR+PR+SD (with CR representing Complete Remission).  

      6. Five patients on compassionate use continued the treatment for a total of 9, 9, 11, 13 and 16 months, respectively. Two patients continuing the treatment have reached 16 months.

    "Advance cases of patients with HCC have limited therapeutic options because of the poor safety and tolerability of existing drugs. Thus, a newer drug, preferentially with a different mechanism of action, such as Milciclib is a necessary medical need," stated Prof. Angelo Sangiovanni, M.D. principal investigator of the study and site investigator at Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy. "In this context, safety, and tolerability of oral treatment with Milciclib is remarkable. Results from the phase 2a clinical study demonstrating clinical activity in these advance cases of HCC are notable. The fact that many of the treated patients continued with the treatment, even after completing 6 months duration of the study, is particularly very impressive."

    Abstract #307309: Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence. First Author: Alessandro Pivetti. MD., et al.

    • Seven patients enrolled to date in this ongoing study

    • Combination treatment of Milciclib and Regorafenib was well tolerated with manageable toxicities

    • Mean AFP levels reduced by 20% within one month of treatment

    • Patients treated for longer duration had 50% reduction in AFP levels

    • Currently, patients enrolled in the study are in 2 to 10 months of treatment period

    "Our center has been involved with clinical evaluation of several drug candidates in advanced HCC patients and both of the above-mentioned studies were conducted at our site. The oral treatment with Milciclib is not only very well tolerated but it also showed clinical activity. Most of these patients with advance cases of HCC are exhibiting stabilization of disease and have continued the treatment under a compassionate use program, which in my opinion is very impressive," added Prof. Erica Villa, M.D., site Investigator at the Policlinico di Modena, Modena, Italy.  "Moreover, the positive clinical activity and impressive safety and tolerability of Milciclib in combination with Regorafenib in liver transplant patients with recurrent HCC is certainly noteworthy. Thus, clinical data from these two studies are very encouraging and warrant continued development of Milciclib, either as monotherapy or combination therapy."

    About Milciclib (TZLS-201)

    Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases such as CDK1, CDK2, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in NSCLC, pancreatic and colon cancer, thymic carcinoma and thymoma.  

    About Tiziana Life Sciences

    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS)) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered Foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    About ASCO

    The American Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer. Membership currently stands at 40,000 physicians and scientists. ASCO is one of the premiere organizations for the advancement of cancer treatments and the annual ASCO meeting is an important forum for discussion of new cancer therapies and treatments.
     For more information go to http://www.tizianalifesciences.com

    THE PERSON WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY'S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.

    Contacts:  
    Tiziana Life Sciences plc  
    United Kingdom:  
    Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
       
    Cairn Financial Advisers LLP (Nominated adviser)  
    Liam Murray / Jo Turner  +44 (0)20 7213 0883
       
    Shore Capital (Broker)  
    Antonio Bossi / Fiona Conroy  +44 (0)20 7601 6125
       
    United States:  
    Investors  
    CORE IR  
    ir@coreir.com  
       
    Media  
    Jules Abraham  
    CORE IR  
    (917) 885-7378  
    julesa@coreir.com  

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  71. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, May 14, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today that a new study will be presented by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company's stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients during a poster discussion session at the American Society of Clinical Oncology…

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, May 14, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today that a new study will be presented by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company's stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients during a poster discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference. The study demonstrates greater refinement and superiority of StemPrintER over current market leader Oncotype DX in delivering prognostic information as part of the therapeutic decision-making process in ER+/HER2- breast cancer patients. An additional abstract from the scientists at the European Institute of Oncology will be presented in a separate poster session, which details a further refined risk model, the SPARE model, based on the combination of StemPrintER with clinical parameters for distant metastasis prediction. Both abstracts, became available May 13, 2020, while the posters and discussion session will be held during The American Society of Clinical Oncology (ASCO) Virtual Conference May 29-31, 2020.

    Each of these studies independently provides significant additional information on the value of StemPrintER -- and its derivative SPARE (detailed below) -- as clinical tools to aid personalized therapeutic decision-making in women with ER+/HER2- breast cancer. Of particular note is the comparative precision of StemPrintER over Oncotype DX in predicting the potential recurrence of certain types of breast cancer following treatment. The two studies highlight the importance of the stem cell approach to develop a potentially powerful prognostic tool to predict breast cancer prognosis.

    Abstract #1020, "Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort," is an independent validation of the prognostic value of StemPrintER in a cohort of more than 800 luminal ER+/HER2- postmenopausal breast cancer patients from the international TransATAC study and a head-to-head comparison of the prognostic power of StemPrintER with Oncotype DX. Results provide independent validation of StemPrintER as a potentially powerful prognostic tool to stratify patients for the risk of early or late recurrence independently of other clinicopathological parameters. Importantly, the study also shows that StemPrintER is superior to Oncotype DX in the prediction of 10-year recurrence risk in all patients, as well as in N0 and N1-3 patients. The study further demonstrates that StemPrintER is capable of outperforming Oncotype DX in providing additional prognostic information to the standard clinicopathological parameters.

    Abstract #1057, "Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients," develops a more refined risk model for distant metastasis prediction, which combines StemPrintER with tumor size (pT) and nodal status (pN). The new model is termed SPARE (StemPrintER for Personalized Adjuvant Therapy in Endocrine Receptor-Expressing Patients) and, in the analysis of a consecutive-retrospective cohort of more than 1,800 ER+/HER2- breast cancer patients with 15-year complete follow-up from the European Institute of Oncology (IEO) in Milan, revealed to be an even more powerful tool, compared to the original StemPrintER for predicting early and late distant metastasis risk independently of standard clinical parameters.

    "These data sets demonstrate that StemPrintER has the potential to become an essential prognostic tool that will help clinicians to tailor more or less aggressive therapy based on a more accurate risk assessment of disease recurrence compared to what we have seen to date," added Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. "This product also represents an important addition to our existing therapeutic pipeline as it opens Tiziana into the area of precision medicine, creating an entirely new business line beyond our current patented technology in offering new delivery mechanisms for monoclonal antibodies."

    About StemPrintER
    StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.

    The person who arranged for the release of this information is Dr Kunwar Shailubhai, the Company's Chief Executive Officer and Chief Scientific Officer.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a dual listed (NASDAQ:TLSA, UK AIMS: TILS)) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn's Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn's Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.

    Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.

    Forward-Looking Statements
    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    Contacts:

    Tiziana Life Sciences plc  
    United Kingdom:  
    Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379 
       
    Cairn Financial Advisers LLP (Nominated adviser)  
    Liam Murray / Jo Turner + 44 (0)20 7213 0883 
       
    Shore Capital (Broker)  
    Antonio Bossi / Fiona Conroy  +44 (0)20 7601 6125
       
    United States:  
    Investors  
    CORE IR  
    ir@coreir.com  
       
    Media  
    Jules Abraham  
    CORE IR  
    (917) 885-7378  
    julesa@coreir.com  

     

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  72. NEW YORK and LONDON, May 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announces that two abstracts on the Company's stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, will be presented at the American Society of Clinical Oncology's 2020 Virtual Conference.  All abstracts, including Abstract #1020, which compares Tiziana's product to current market leader Oncotype DX as part of a poster discussion session, will be available online beginning May 13, 2020 beginning at 5:00 PM ET at abstracts.asco.org.  The American Society…

    NEW YORK and LONDON, May 11, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announces that two abstracts on the Company's stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, will be presented at the American Society of Clinical Oncology's 2020 Virtual Conference.  All abstracts, including Abstract #1020, which compares Tiziana's product to current market leader Oncotype DX as part of a poster discussion session, will be available online beginning May 13, 2020 beginning at 5:00 PM ET at abstracts.asco.org.  The American Society of Clinical Oncology (ASCO) Virtual Conference will be held from May 29-31, 2020.

    In addition, the Company will publish online two e-abstracts featuring its Miliciclib compound for the treatment of hepatocellular carcinoma on 13 May 2020 but which will not be presented as part of the conference.

    Abstracts include:

    Poster Discussion Session, Breast Cancer, Metastatic:

    • Abstract #1020: "Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort"

    Poster Session, Breast Cancer, Metastatic:

    • Abstract #1057: "Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients"

    e-Abstracts include:

    • e16711: "Phase 2a safety and efficacy of Milciclib, a pan-cyclin dependent kinase inhibitor, in unresectable, sorafenib-refractory or -intolerant hepatocellular carcinoma patients"
    • e16634: "Safety and clinical activity of combination treatment with regorafenib and milciclib in liver transplant patients with hepatocellular carcinoma recurrence"

    "These data being presented at ASCO are significant for our oncology portfolio and highlight a complementary technology for detection of breast cancer," said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.  "Of particular note is that one of these studies was selected to be part of a poster discussion session during the meeting.  We look forward to sharing these critical data on our StemPrintER clinical diagnostic for ER+/HER2- breast cancer patients and its utility in potentially optimizing therapeutic decision-making, especially in the discussion of StemPrintER relative to the current market leader, Oncotype DX."

    About StemPrintER
    StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.

    About Milciclib
    Milciclib is a potent, small molecule inhibitor of multiple cyclin-dependent kinases (CDKs), tropomycin receptor kinases and Src family kinases controlling cell growth and malignant progression of cancer. Milciclib has demonstrated safety in 316 patients with advanced solid cancers in Phase I and II studies and shown indications of efficacy. In two completed Phase II thymic cancer trials, Milciclib successfully increased overall survival and met both primary and secondary endpoints. While the current standard of care for hepatocellular carcinoma (HCC), the most common liver cancer, is only effective in a small percentage of patients, Milciclib has the potential to be broadly effective because it targets the underlying cause of disease. A unique feature of Milciclib is its ability to reduce microRNAs, miR-221 and miR-222, that promote the formation of blood vessels (angiogenesis) to facilitate the spread of cancer cells. Levels of these microRNAs are consistently increased in HCC patients and may contribute towards resistance to treatment with Sorafenib.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.

    Forward-Looking Statements
    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    Contacts:
    Tiziana Life Sciences plc

    United Kingdom:
    Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379

    Cairn Financial Advisers LLP (Nominated adviser)
    Liam Murray / Jo Turner + 44 (0)20 7213 0883

    Shore Capital (Broker)
    Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125

    United States:
    Investors
    CORE IR
    ir@coreir.com 

    Media
    Jules Abraham
    CORE IR
    (917) 885-7378
    julesa@coreir.com 

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  73. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, April 27, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory, autoimmune and infectious diseases, announced today that it has filed a provisional patent application on the combination of nanoparticle-Actinomycin D (NP-ACT D) with anti-interleukin-6 receptor monoclonal antibody (anti-IL-6R) as a potential therapy for management of COVID-19 disease. The underlying invention concepts are based on the hypothesis that a combination of an antiviral drug controlling proliferation of COVID-19, with an anti-inflammatory…

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, April 27, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory, autoimmune and infectious diseases, announced today that it has filed a provisional patent application on the combination of nanoparticle-Actinomycin D (NP-ACT D) with anti-interleukin-6 receptor monoclonal antibody (anti-IL-6R) as a potential therapy for management of COVID-19 disease. The underlying invention concepts are based on the hypothesis that a combination of an antiviral drug controlling proliferation of COVID-19, with an anti-inflammatory agent (e.g., anti-IL-6R) suppressing a possible ‘Cytokine Storm' may provide immediate relief to severe cases of COVID-19 patients. 

    Actinomycin D (ACT D), an antibiotic drug approved initially for infectious diseases in the United States in 1964, is on the World Health Organization's List of Essential Medicines as the most effective medicine needed in a health system (1). However, severe toxicities associated with the intravenous administration of ACT D limits its widespread therapeutic utility. The NP-ACT D formulation, effectively controlling slow and sustained release, may overcome the severe toxicities of ACT D. Side-by-side animal studies have compared NP-ACT D with free ACT D and demonstrated that the intravenous treatment with NP-ACT D was well-tolerated with minimal apparent toxicities in animal models. Importantly, results from another animal study comparing free ACT D side-by-side with an equivalent dose of NP-ACT D, showed 0% mortality in rats dosed with NP-ACT D as compared to > 90% mortality with free ACT D (2). Nonetheless, safety and tolerability of NP-ACT D needs to be evaluated in healthy volunteers prior to any clinical studies.     

    Patients infected with COVID-19 are known to develop an uncontrolled immune response ("cytokine storm"), which results in excessive production of pro-inflammatory cytokines such as IL-6 and TNF-a both of which are regarded as key drivers of chronic inflammation and are believed to be associated with severe lung damage commonly observed in patients with COVID-19 infections and acute respiratory distress syndrome (ARDS). Therefore, Tiziana believes it is possible to potentially combine TZLS-501 (anti-IL6R) with NP-Act D to inhibit viral proliferation and to suppress inflammation in lungs to halt progression of COVID-19-mediated lung damage and death.

    Citations

    1. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO
    2. Shailubhai, K. Dactinomycin compositions and methods for the treatment of myelodysplastic syndrome and acute myeloid leukemia. US PCT: 2018/0092857 A1

    It is important to note that the Company has not, at the current time, conducted any clinical or pre-clinical research into the use of NP-ACT D, either alone or in combination with anti-interleukin-6 receptor monoclonal antibody (anti-IL-6R) as a treatment for COVID-19, but is basing its assessment for the combination's potential on research and anecdotal evidence involving NP-ACT D activity on other strains of coronavirus and established theoretical principles underlying combinations of drugs.

    About TZLS-501
    TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα can be shed as a soluble sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from this complex mediates pro-inflammatory effects underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, a major cause of lung damage, suggests a potential role for this mAb in patient management and treatment of COVID-19.  

    About NP-Act D
    Broad-spectrum antibiotics that have been deemed ‘safe-in-man' through testing in early phase clinical trials have been touted as good drug repurposing candidates for treatment of emerging infectious diseases. Actinomycin D, an inhibitor of RNA-dependent RNA polymerase, is a potent antibiotic with therapeutic utility in infectious diseases and cancer. As intravenous administration of Actinomycin D is known to produce severe toxicities, its therapeutic utility has been limited. The nanoparticle-based Actinomycin D (NP-ACT D) is formulated to control a slow release of Act D such that the Cmax (maximum serum concentration) in blood can be adjusted to a desired level. In animal studies, NP-Act D was found to produce minimal toxicities and it was found to be safe and well-tolerated.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
    Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

    Forward-Looking Statements
    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    THE PERSON WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY'S CHIEF EXECUTIVE AND CHIEF MEDICAL OFFICER.

    Contacts:
    Tiziana Life Sciences plc

    United Kingdom:

    Tiziana Life Sciences plc
    Gabriele Cerrone, Chairman and founder 
    +44 (0)20 7495 2379
     
    Cairn Financial Advisers LLP (Nominated adviser)
    Liam Murray / Jo Turner 
     

    +44 (0)20 7213 0883
       
    Shore Capital (Broker)
    Antonio Bossi / Fiona Conroy
    +44 (0)20 7601 6125

     

    United States:
    Investor Inquiries:
    ir@coreir.com

    Media
    pr@coreir.com

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  74. Nanoparticle Actinomycin formulation minimizes toxicity and enhances tolerability by slow release of drug to control Cmax in blood

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, United Kingdom, April 24, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory, autoimmune and infectious diseases, announced today that it pursuant to an asset purchase agreement it has acquired all of the intellectual property relating to a nanoparticle-based formulation of Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc. ("Rasna") to expand its pipeline…

    Nanoparticle Actinomycin formulation minimizes toxicity and enhances tolerability by slow release of drug to control Cmax in blood

    This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

    NEW YORK and LONDON, United Kingdom, April 24, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory, autoimmune and infectious diseases, announced today that it pursuant to an asset purchase agreement it has acquired all of the intellectual property relating to a nanoparticle-based formulation of Actinomycin D (Act D; a.k.a. Dactinomycin), from Rasna Therapeutics, Inc. ("Rasna") to expand its pipeline for a consideration of an initial $120,000 upfront payment and milestone payments of up to an additional aggregate $630,000.

    This formulation technology was invented by Dr. Kunwar Shailubhai when he was previously an executive officer at Rasna, which he remains a director.

    Act D, an antibiotic drug, was approved initially for infectious diseases in the United States in 1964. Subsequently, this antibiotic was shown to exhibit anti-cancer activity in 1974 (1). Since then the drug has been used to treat various types of cancer, including Wilms tumor, rhabdomyosarcoma, Ewing's sarcoma, trophoblastic neoplasm, and testicular cancer. The drug is on the World Health Organization's List of Essential Medicines as the most effective medicines needed in a health system (2). Falini et al., reported in New England Journal of Medicine that intravenous administration of Act D could be used for treatment of patients with Acute Myeloid Leukemia (AML) carrying NPM1 gene mutation (3). Recent studies have also suggested that Act D, being a potent inhibitor of RNA synthesis, may have potential for treatment of COVID-19 patients (4). Currently, the drug is intravenously (IV) administered, which produces severe toxicities possibly due to excessive Cmax in blood during the first couple of hours after administration.

    The nanoparticle-based Act D (NP-ACT D) is formulated such that the release of Act D is slow and Cmax in blood may be pre-adjusted to a desired level. In pharmacokinetics (PK) and safety studies in rats, free Act D or an equivalent dose of NP-Act D were intravenously administered side-by-side to compare PK, tolerability, and toxicity. Results from these animal studies indicated that the PK of NP-Act D was slow, and sustained for over 32 hours, whereas the PK in blood within an equivalent dose of free Act D activity was rapid. Importantly, another study comparing side-by-side free Act D with an equivalent dose of NP-Act D, showed 0% mortality in rats dosed with NP-Act D for up to 13 days. By contrast, mortality in rats dosed with free Act D began on 6th day, reaching >90% mortality on 13th day of the study. These results demonstrate that PK of IV administered NP-Act D is slow and sustained for extended period and it is relatively well-tolerated with minimal toxicities. However, safety and tolerability of NP-Act D needs to be evaluated in healthy volunteers prior to clinical studies.

    It is important to note that the Company has not, at the current time, conducted any clinical or pre-clinical research into the use of NP-ACT D as a treatment for COVID-19 but is basing its assessment for potential on research involving NP-ACT D with other strains of coronavirus.

    Citations

    1. Hollstein U (1974). "Actinomycin. Chemistry and mechanism of action". Chemical Reviews. 74 (6): 625–652. 
    2. World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO
    3. Falini B, Mecucci C, Tiacci E, et al. Cytoplasmic nucleophosmin in acute myelogenous leukemia with a normal karyotype. N Engl J Med 2005; 352:254-66.
    4. Kennedy, D.A., and Johnson-Lussenburg (1978). Inhibition of Coronavirus 229E Replication by Actinomycin D JOURNAL OF VIROLOGY, Jan. 1978, p. 401-404.

    About NP-Act D
    Broad-spectrum antibiotics that have been deemed ‘safe-in-man' through testing in early phase clinical trials have been touted as good drug repurposing candidates for treatment of emerging infectious diseases. Actinomycin D, an inhibitor of RNA-dependent RNA polymerase, is a potent antibiotic with therapeutic utilities in infectious diseases and cancer. As intravenous administration of Actinomycin D is known to produce severe toxicities, its therapeutic utility has been limited. The nanoparticle-based Actinomycin D (NP-ACT D) is formulated to control and slow release of Act D such that the Cmax in blood can be adjusted to a desired level. In animal studies, NP-Act D was found to produce minimal toxicities and it was found to safe and well-tolerated.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.
    Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

    Forward-Looking Statements
    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    The person who arranged for the release of this information was Dr Kunwar Shailubhai, the Company's Chief Executive and Chief Medical Officer.


    Contacts:
    Tiziana Life Sciences plc    
    United Kingdom:    
    Gabriele Cerrone, Chairman and founder        +44 (0)20 7495 2379
         
    Cairn Financial Advisers LLP (Nominated adviser)    
    Liam Murray / Jo Turner    + 44 (0)20 7213 0883
         
    Shore Capital (Broker)    
    Antonio Bossi / Fiona Conroy    +44 (0)20 7601 6125
         
    United States:    
    Investors    
    Scott Gordon    
    CORE IR    
    (516) 222-2560    
    scottg@coreir.com     
         
    Media    
    Jules Abraham    
    CORE IR    
    (917) 885-7378    
    julesa@coreir.com     

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  75. NEW YORK and LONDON, April 09, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced today that it has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer. Development of this novel technology is a step forward toward expediting  development of  TZLS-501, a fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus.  The Company believes…

    NEW YORK and LONDON, April 09, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (NASDAQ:TLSA) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for inflammatory and autoimmune diseases, announced today that it has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor (anti-IL-6R) monoclonal antibodies (mAbs) into the lungs using a handheld inhaler or nebulizer. Development of this novel technology is a step forward toward expediting  development of  TZLS-501, a fully-human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for treatment of patients infected with COVID-19 (SARS-CoV-2) coronavirus.  The Company believes the technology could also be applicable for use with other FDA approved mAbs and drugs.  The Company has submitted a provisional patent application for the delivery technology.

    "Direct delivery of anti-IL-6R mAb to the lungs using a portable handheld inhaler or nebulizer is a rapid and immediate therapy for children and adults infected with COVID-19.  Importantly, this treatment with our fully human anti-IL-6R mAb (TZLS-501) has the potential to be a long-term therapy to halt progression and reduce mortality in patients with COVID-19, as a portion of the population may not opt to utilize a vaccine," said Gabriele Cerrone, Chairman of Tiziana Lifesciences.  

    Patients infected with COVID-19 are known to develop an uncontrolled immune response ("cytokine storm"), which results in excessive production of pro-inflammatory cytokines and other proteins such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a) and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which in turn causes severe damage to lung tissue resulting in respiratory failure and eventually death. Among these cytokines, IL-6 seems to be one of the major culprits underlying coronavirus-mediated respiratory failure. Early clinical studies conducted by doctors in China suggest that anti-IL6R mAbs may be used in clinical practice for treatment of COVID-19.  Consequently, China's National Health Commission has recommended the use of Roche's blockbuster drug, Actemra® and Sanofi's Kevzera® for treatment of patients infected with COVID-19.  

    Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with the severe lung damage commonly observed with COVID-19 infections and acute respiratory distress syndrome (ARDS).  Tiziana believes TZLS-501 (anti-IL6R) combined with this newly introduced inhalation technology may rapidly inhibit inflammation in lungs and in combination with intravenous administration may deplete circulating levels of IL-6 and potentially halt progression of COVID-19-mediated lung damage and death.

    "The filing of this comprehensive provisional patent application covering treatment with our anti-IL-6R mAb, as well as prophylactic intervention with a vaccine candidate, designed from Spike (S) protein of COVID-19, is an important step in finding a solution to the current pandemic. We look forward to providing updates on the development of this product candidate and its introduction into clinical trials in a real-world setting," said Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences.

    About TZLS-501
    TZLS-501, a fully human mAb, was acquired from Novimmune, a Swiss biotechnology company, in 2017. The cytokine, IL-6, a major determinant in the priming of pathogenic T cells to produce an inflammatory response, binds to its receptor subunit IL-6Rα on the cell membrane. The receptor IL-6Rα can be shed as a soluble sIL6Rα, which binds to circulating IL-6 cytokine in the blood. The downstream signaling from which sIL-6R is implicated mediates pro-inflammatory effect underlying the inflammatory diseases such as rheumatoid arthritis (RA) and acute respiratory distress syndrome (ARDS). The Company believes that the novel features of TZLS-501 consisting of its dual mechanism of action to inhibit signaling by the membrane-bound and soluble IL-6 receptor and the rapid depletion of circulating IL-6 cytokines, which is the major cause of lung damage, provides this mAb with distinct advantages for treatment of COVD-19.  The Company licensed TZLS-501 from Novimmune, a Swiss biotechnology company, in 2017.

    About Tiziana Life Sciences
    Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis ("NASH"), ulcerative colitis, multiple sclerosis, type-1 diabetes ("T1D"), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable.

    Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts straight to you on https://ir.tizianalifesciences.com

    Forward-Looking Statements
    Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,' ‘expects,' ‘intends,' ‘plans,' ‘believes,' 'seeks,' ‘estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

    Contacts:
    Tiziana Life Sciences plc
    United Kingdom:
    Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
    Cairn Financial Advisers LLP (Nominated adviser)
    Liam Murray / Jo Turner + 44 (0)20 7213 0883
    Shore Capital (Broker)
    Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125

    United States:
    Investors
    Scott Gordon
    CORE IR
    (516) 222-2560
    scottg@coreir.com

    Media
    Jules Abraham
    CORE IR
    (917) 885-7378
    julesa@coreir.com

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  76. LONDON and NEW YORK, March 16, 2020 /PRNewswire/ -- Tiziana Life Sciences plc (NASDAQ:TLSA) (AIM: TILS) (the "Company" or "Tiziana"), a U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today announces the closing of its underwritten follow-on public offering (the "Offering") of American Depositary Shares ("ADSs") on the NASDAQ Global Market. Tiziana  issued 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares")) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (before deducting underwriting discount, commissions and…

    LONDON and NEW YORK, March 16, 2020 /PRNewswire/ -- Tiziana Life Sciences plc (NASDAQ:TLSA) (AIM: TILS) (the "Company" or "Tiziana"), a U.S. and U.K. biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology, today announces the closing of its underwritten follow-on public offering (the "Offering") of American Depositary Shares ("ADSs") on the NASDAQ Global Market. Tiziana  issued 3,333,333 ADSs (representing 16,666,665 new ordinary shares of nominal value £0.03 each in the capital of the Company ("Ordinary Shares")) at a price to the public of $3.00 per ADS raising gross proceeds of approximately $10 million (before deducting underwriting discount, commissions and offering expenses). Each ADS offered represents five (5) Ordinary Shares. In addition, Tiziana has granted the underwriters a 45-day option to purchase up to an additional 499,999 ADSs on the same terms and conditions (the "Option").  All ADSs sold in the Offering were offered by the Company. The number of Ordinary Shares represented by ADSs comprised in the Offering (including by way of the exercise of the Option) were within existing shareholder authorities.

    ThinkEquity, a division of Fordham Financial Management, Inc., acted as the sole book-running manager for the Offering.

    Tiziana intends to use the net proceeds received from this Offering (i) to advance the clinical development of Foralumab, (ii) to expedite clinical development of TZLS-501 for coronavirus COVID-19, and (iii) for working capital and other general corporate purposes.

    Tiziana's Ordinary Shares are admitted to trading on AIM, a market of the London Stock Exchange plc ("AIM"), under the symbol "TILS". The ADSs are listed for trading on the Nasdaq Global Market under the symbol "TLSA". 

    This Offering was being made pursuant to a registration statement on Form F-3, as amended (File No. 333-236013), previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective on February 6, 2020.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. A preliminary prospectus supplement and accompanying base prospectus relating to this offering have been filed with the SEC and are available at the SEC's website at http://www.sec.gov. Before investing in Tiziana's securities, you should read the preliminary prospectus supplement and the accompanying base prospectus and the documents incorporated by reference therein for information about Tiziana and this Offering. A final prospectus supplement related to the Offering will also be filed with the SEC.

    Copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at prospectus@think-equity.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the SEC's website at http://www.sec.gov.

    Total Voting Rights

    In conformity with DTR 5.6.1, the Company notifies that as at the date of this announcement, it has a single class of shares in issue being Ordinary Shares and that following the issue of the Ordinary Shares to be issued in the Offering (excluding any to be issued pursuant to the Option), the total number of Ordinary Shares in issue is 153,321,181.  There are no Ordinary Shares held in