TLSA Tiziana Life Sciences plc

2.59
+0.1  (+4%)
Previous Close 2.49
Open 2.55
52 Week Low 0.616
52 Week High 12.17
Market Cap $252,022,913
Shares 97,306,144
Float 97,306,144
Enterprise Value $209,489,251
Volume 419,348
Av. Daily Volume 290,825
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Drug Pipeline

Drug Stage Notes
Milciclib and Sorafenib (Nexavar)
Hepatocellular carcinoma (HCC)
Phase 2b
Phase 2b
Phase 2b trial planned.
Foralumab
Crohn’s Disease
Phase 2
Phase 2
Phase 2 trial to commence 2H 2020.
TZLS-501
Coronavirus COVID-19
Phase 1
Phase 1
Phase 1 trial planned.

Latest News

  1. 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)





    Primary Logo

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  2. 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)



     



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  3. 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)



      

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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

     

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  4. 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)



    United Kingdom Investors:

    Tiziana Life Sciences plc

    Hana Malik, Investor Relations

    +44 (0)20 7495 2379

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