DTIL Precision BioSciences Inc.

12.71
+0.22  (+2%)
Previous Close 12.49
Open 12.58
52 Week Low 5.225
52 Week High 16.6
Market Cap $757,293,149
Shares 59,577,779
Float 53,284,783
Enterprise Value $576,834,459
Volume 91,035
Av. Daily Volume 427,538
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Upcoming Catalysts

Drug Stage Catalyst Date
PBCAR269A
Multiple myeloma
Phase 1/2
Phase 1/2
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PBCAR20A
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
PBCAR0191
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 updated presented at ASCO June 4, 2021- overall response rates (ORR) and complete response (CR) rates of 75% and 50%, respectively at Day ≥ 28.
PBGENE-HBV
Chronic Hepatitis B Virus (HBV)
Phase 1
Phase 1
IND/CTA expected in 2024.
PBGENE-PH1
Primary Hyperoxaluria type 1 (PH1)
Phase 1
Phase 1
IND application expected 2023.
PBGENE-PCSK9
Familial Hypercholesterolemia
Phase 1
Phase 1
Phase 1 clinical studies with CTA filing expected as early as 2022.
PBCAR19B
Non-Hodgkin Lymphoma (NHL)
Phase 1
Phase 1
Phase 1 initiation of dosing announced July 1, 2021.

Latest News

  1. 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, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held from September 13-15, 2021.

    The pre-recorded presentation will be made available for on-demand viewing starting Monday, September 13, 2021 at 7:00 a.m. ET on the Company's website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations. An archived replay of the webcast will be available for approximately 90 days.

    About Precision BioSciences, Inc.

    Precision BioSciences, Inc. is a clinical stage biotechnology…

    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, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held from September 13-15, 2021.

    The pre-recorded presentation will be made available for on-demand viewing starting Monday, September 13, 2021 at 7:00 a.m. ET on the Company's website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations. An archived replay of the webcast will be available for approximately 90 days.

    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.

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  2. iECURE to License Precision's PCSK9-Directed ARCUS Nuclease and Pursue Four Gene Insertion Programs Focused on Liver Diseases; Precision Retains Rights Across All Indications Except Those Licensed to iECURE

    iECURE Expects to File a Clinical Trial Application as Early as 2022 for Precision's PBGENE-PCSK9 Candidate for Familial Hypercholesterolemia

    Preclinical Data for ARCUS-Mediated Gene Insertion to be Presented Today by iECURE Chief Scientific Advisor, James M. Wilson, M.D., Ph.D. at Precision's Gene Editing R&D Event

    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 iECURE, a mutation-agnostic…

    iECURE to License Precision's PCSK9-Directed ARCUS Nuclease and Pursue Four Gene Insertion Programs Focused on Liver Diseases; Precision Retains Rights Across All Indications Except Those Licensed to iECURE

    iECURE Expects to File a Clinical Trial Application as Early as 2022 for Precision's PBGENE-PCSK9 Candidate for Familial Hypercholesterolemia

    Preclinical Data for ARCUS-Mediated Gene Insertion to be Presented Today by iECURE Chief Scientific Advisor, James M. Wilson, M.D., Ph.D. at Precision's Gene Editing R&D Event

    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 iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, today announced a license and collaboration agreement under which iECURE plans to advance Precision's PBGENE-PCSK9 candidate into Phase 1 studies and gain access to Precision's PCSK9-directed ARCUS nuclease to develop additional gene editing therapies for genetic diseases, initially targeting liver diseases.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210909005309/en/

    Under the terms of the agreement, iECURE plans to file a clinical trial application as early as 2022 to advance the PBGENE-PCSK9 clinical candidate through Phase 1 clinical studies for the treatment of familial hypercholesterolemia (FH). Precision will retain rights to PBGENE-PCSK9, including all products developed for genetic indications with increased risk of severe cardiovascular events such as FH. In return, Precision has granted iECURE a license to use its PCSK9-directed ARCUS nuclease to insert genes into the well-characterized PCSK9 locus to develop treatments for four other pre-specified rare genetic diseases. Precision will receive an equity stake in iECURE and is eligible to receive milestone and royalty payments on sales of iECURE products developed with ARCUS.

    "We are excited to continue working with Jim Wilson under this new in vivo gene editing license and collaboration agreement with iECURE, as iECURE looks to rapidly advance our PBGENE-PCSK9 candidate, file for a clinical trial application in 2022, and use our PCSK9-directed ARCUS nuclease, and its knock-in capabilities, to pursue new treatments for rare genetic diseases," said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. "Through this collaboration we expect to gain important clinical validation for in vivo gene editing with ARCUS, while retaining rights to this PCSK9-directed nuclease, which we believe offers a safe harbor locus for DNA gene editing knock-in without deleterious effects when the PCSK9 gene is disrupted."

    "We founded iECURE with the aim of focusing on genetic diseases with significant unmet need that we could target in a mutation-agnostic manner. After evaluating different gene editing technologies and platforms, we believe gene editing with ARCUS, including use of the uniquely designed ARCUS nuclease as a gene insertion tool targeting the PCSK9 gene will help us rapidly advance several candidates to the clinic with the potential to deliver on the promise of highly efficient, specific, and safe gene insertion," said Joe Truitt, Chief Executive Officer of iECURE. "We are excited to partner with Precision on this key pillar of our gene editing strategy, to advance this work for rare genetic diseases."

    James M. Wilson, M.D., Ph.D., Chief Scientific Advisor of iECURE and Professor in the Departments of Medicine and Pediatrics, Perelman School of Medicine, University of Pennsylvania, Director, Gene Therapy Program, will present new non-human primate data demonstrating ARCUS-mediated gene addition today, September 9, 2021 during the Precision BioSciences gene editing R&D event. Dr. Wilson and his team have demonstrated in non-human primates that it is possible to use ARCUS to insert new genes stably into the PCSK9 locus, which could be used as a potential approach for treating multiple genetic diseases with a single therapeutic strategy.

    About ARCUS

    ARCUS® is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock in), remove (knockout), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision's platform and products are protected by a comprehensive portfolio including more than 80 patents to date.

    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 iECURE

    iECURE is an in vivo gene editing company striving to cure liver disorders with high unmet need. We are advancing our pipeline in close partnership with the world-class translational engine at the University of Pennsylvania's Gene Therapy Program. Using in vivo editing, our methods focus on inserting functioning genes into patients' genomes, which offers long-term, stable expression of those genes. With our team's proven track record, reversing the course of these devastating disorders is now hopefully within reach.

    Financial disclosure: The University of Pennsylvania and Dr. James Wilson hold equity interests in iECURE, receive significant sponsored research support from the company, and will be entitled to receive licensing revenues from iECURE based on successful technology development and commercialization of the licensed technology.

    Precision's 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 iECURE to develop and commercialize gene editing therapies using the Company's PCSK9-directed ARCUS nuclease for cardiovascular and rare genetic diseases, the timing of clinical trials and results therefrom, any future milestones or royalty payments thereunder, the development and commercial potential of ARCUS-mediated gene addition and the potential value of iECURE equity. In some cases, you can identify forward-looking statements by terms such as "aim," "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "target," "mission," "goal," "may," "will," "would," "should," "could," "target," "potential," "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 and effects of restrictions thereunder; risks associated with raising additional capital; 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 limited ability or inability to assess the safety and efficacy of our product candidates; 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 obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators' ability to enroll patients; changes in interim "top line" and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, 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 and reliance on 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 executives and personnel; market and economic conditions; effects of system failures and security breaches; 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, which are 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 have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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  3. - Accelerated Clinical Development Expected to Enable Three Investigational New Drug/Clinical Trial Applications Within Next Three Years, Including for Familial Hypercholesterolemia as early as 2022, Primary Hyperoxaluria Type 1 in 2023, and Chronic Hepatitis B in 2024

    - Announced Licensing and Collaboration Agreement with iECURE to Advance PCSK9 Knockout Program for Familial Hypercholesterolemia Through Phase 1; iECURE Also Receives License to Develop Four ARCUS-Based Gene Insertion Programs

    - Featured Preclinical Data Demonstrating Precision and Versatility of ARCUS Editing Platform, Including First Presentation of ARCUS-Mediated Gene Insertion in Non-Human Primates

    - Gene Editing Event Broadcast at 8:00 am ET Includes Presentation by

    - Accelerated Clinical Development Expected to Enable Three Investigational New Drug/Clinical Trial Applications Within Next Three Years, Including for Familial Hypercholesterolemia as early as 2022, Primary Hyperoxaluria Type 1 in 2023, and Chronic Hepatitis B in 2024

    - Announced Licensing and Collaboration Agreement with iECURE to Advance PCSK9 Knockout Program for Familial Hypercholesterolemia Through Phase 1; iECURE Also Receives License to Develop Four ARCUS-Based Gene Insertion Programs

    - Featured Preclinical Data Demonstrating Precision and Versatility of ARCUS Editing Platform, Including First Presentation of ARCUS-Mediated Gene Insertion in Non-Human Primates

    - Gene Editing Event Broadcast at 8:00 am ET Includes Presentation by James M. Wilson, M.D., Ph.D., Professor in the Departments of Medicine and Pediatrics, Perelman School of Medicine, University of Pennsylvania and Chief Scientific Advisor of iECURE

    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, today provided strategic business updates on its in vivo gene editing pipeline during the Company's first gene editing R&D event.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210909005318/en/

    "Gene editing promises to fundamentally reshape the treatment landscape across numerous therapeutic categories. Today's in vivo gene editing R&D event showcases the power of our ARCUS genome editing platform – including key demonstrations of capabilities, such as gene insertion and mitochondrial DNA gene editing – which offers distinct advantages in this emerging field," commented Matt Kane, CEO and co-founder of Precision BioSciences. "We are excited to announce a new collaboration with iECURE which we expect to help us expedite clinical validation of the ARCUS platform for both gene knockout and gene insertion."

    "Today, we are excited to share additional data highlighting the precision and versatility of our ARCUS platform, which is designed to enable safe, specific and efficient gene editing. Since ARCUS can be delivered via AAV or LNP, it has potential utility in treating diseases in the liver as well as many genetic diseases that affect tissues beyond the liver. In addition, the unique enzymology of ARCUS enables it to make complex gene insertion and gene repair edits more efficiently than other editing platforms," said Derek Jantz, Ph.D., Chief Scientific Officer and co-founder of Precision. "We believe these unique attributes of ARCUS support its differentiation for in vivo use and its potential to treat a broader range of genetic diseases than other editing technologies. We are very excited about our near-term pipeline and expect ARCUS to deliver on its full promise as we take on more challenging programs."

    Precision expects that three of its preclinical programs will advance to investigational new drug (IND)/clinical trial application (CTA) in the next three years:

    • As part of an agreement to expedite development, iECURE expects to advance Precision's PBGENE-PCSK9 candidate for familial hypercholesterolemia (FH) through Phase 1 clinical studies with CTA filing expected as early as 2022.
    • Precision has initiated IND-enabling activities and expects to submit an IND application for PBGENE-PH1 for primary hyperoxaluria type 1 (PH1) in 2023.
    • Precision will pursue clinical development of its PBGENE-HBV candidate for chronic hepatitis B virus (HBV) and expects to submit an IND/CTA in 2024.

    Announced today in a separate release, Precision BioSciences has signed a license and collaboration agreement with iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, co-founded by James M. Wilson, M.D., Ph.D. Using Precision's PCSK9-directed ARCUS nuclease, iECURE plans to advance Precision's PBGENE-PCSK9 candidate into a Phase 1 study in FH and gain access to Precision's PCSK9-directed ARCUS nuclease to develop four other pre-specified gene insertion therapies for genetic diseases, focusing initially on liver diseases. Precision will retain rights to PBGENE-PCSK9, including for FH and all products developed for genetic indications except those licensed to iECURE. In return for its license grant, Precision will receive an equity stake in iECURE and is eligible to receive milestone and royalty payments on sales of iECURE products developed with ARCUS.

    Presentations from Precision's in vivo Gene Editing R&D event will highlight the Company's clinical development strategy and updates on the following wholly-owned and partnered preclinical programs using ARCUS-mediated editing:

    Featured Preclinical Data

    • ARCUS for Gene Insertion into the PCSK9 locus: Due to the unique type of cut made by ARCUS nucleases, we believe ARCUS may be better suited for gene insertion than CRISPR-based gene editing tools. In non-human primates (NHPs), ARCUS was observed to be more efficient than CRISPR at inserting a Factor IX transgene into the PCSK9 locus. The Factor IX transgene is responsible for making the coagulation Factor IX protein associated with hemophilia B bleeding disorder.

    "Research conducted by the Gene Therapy Program has shown ARCUS is capable of precise edits that can be applied broadly across genetic diseases in a mutation-dependent manner," said Dr. James M. Wilson. "Additionally, as reported today, ARCUS has demonstrated highly efficient gene insertion with a PCSK9-directed nuclease that will be foundational to iECURE in addressing rare genetic diseases, as well as long-term durability reflecting its curative potential with a single administration. Taken together, these findings continue to support what we have learned over years of collaborating with Precision: that the unique properties of ARCUS are differentiated versus other tools in this field."

    • ARCUS for Chronic HBV (PBGENE-HBV): Current standard-of-care treatments for HBV suppress viral replication, but often do not clear the virus, leaving covalently closed circular DNA (cccDNA) and integrated HBV genomes that enable viral persistence. Precision's gene editing program for HBV applies ARCUS to knockout this persistent cccDNA and potentially further reduce viral persistence.

    New preclinical data to be presented today, and data previously presented at the American Society of Gene & Cell Therapy Annual Meeting, show that ARCUS efficiently targeted and degraded HBV cccDNA in HBV-infected primary human hepatocytes and reduced expression of HBV S-antigen (HBsAg) by as much as 95%. Similar levels of HBsAg reduction were observed in a newly developed mouse model of HBV infection following administration of ARCUS mRNA using lipid nanoparticle (LNP) delivery. Precision will pursue clinical development of its PBGENE-HBV candidate using LNP delivery and expects to submit an IND in 2024.

    • ARCUS for Mitochondrial Genome Editing: Mitochondrial diseases frequently are caused by pathogenic mutations in the mitochondrial genome that reduce the ability of mitochondria to convert food and oxygen into energy to sustain life and support organ function. Mitochondrial diseases affect approximately 1 in 5,000 individuals.

    Recent preclinical studies used mitochondrial-targeted ARCUS (mitoARCUS) to selectively eliminate mutant mitochondrial genomes that cause disease in cell and animal models. In work conducted by Precision BioSciences, a hybrid cell model with a mixture of wild-type (healthy) and mutant mitochondrial genomes, a single treatment with mitoARCUS mRNA converted the cells to >99% wild-type. Work led by Carlos T. Moraes, Ph.D., Esther Lichtenstein Professor in Neurology at the University of Miami Miller School of Medicine and in a mouse model of mitochondrial disease and published online in Nature Communications on May 28, 2021, found that mitoARCUS delivered by AAV effectively targeted and depleted mutant mitochondrial genomes in multiple tissues. No editing of potential nuclear off-target sites could be detected, and liver and skeletal muscle showed robust elimination of mutant mtDNA with concomitant restoration of markers of mitochondrial function.

    • ARCUS for FH (PBGENE-PCSK9): Precision's gene editing program for FH seeks to knockout expression of the PCSK9 gene. As published by Wang et al. in Molecular Therapy in June 2021, "Long-term Stable Reduction of Low-density Lipoprotein in Nonhuman Primates Following In Vivo Genome Editing," PBGENE-PCSK9 is supported by extensive NHP data over a three-year period, which demonstrates a long-term, stable edit accompanied by up to an 82% reduction from baseline in PCSK9 levels and up to a 62% reduction in LDL levels.

    Data will be presented on the clinical nuclease which is expected to be delivered by AAVrh79 in a Phase 1 clinical study to be conducted by iECURE.

    • ARCUS for PH1 (PBGENE-PH1): Precision's gene editing program for PH1 applies ARCUS to knockout the well-characterized HAO1 gene to prevent the production of a toxic metabolite called oxalate that causes extremely severe and potentially fatal kidney stone accumulation in patients.

    NHP data supporting this approach has shown, on average, a 98.0% reduction in HAO1 mRNA and a 97.9% reduction in the encoded protein after a single administration of an AAV vector encoding ARCUS. Compared to published results with siRNAs targeting HAO1, Precision's approach appeared to provide an improved metabolic profile with the potential for long-term benefit from a single dose. Precision has initiated IND-enabling activities and expects to submit an IND application for this program in 2023 using LNP delivery.

    • ARCUS for Duchenne Muscular Dystrophy (DMD) (PBGENE-DMD): ARCUS genome editing has previously been shown to increase expression of a shortened version of dystrophin in cultured myoblasts from a DMD patient. The approach uses two ARCUS nucleases delivered by a single AAV to simultaneously cut and delete a large segment of the dystrophin gene that encodes exons 45 through 55 of dystrophin – a region of the gene that accounts for more than 50% of DMD-causing mutations.

    In November 2020, Precision and Lilly announced an exclusive license agreement to utilize ARCUS genome editing for the research and development of up to six potential in vivo targets for genetic disorders. The collaboration initially included three gene targets, with the lead program targeting the dystrophin gene responsible for DMD (PBGENE-DMD). In addition, Precision will use ARCUS for one liver-directed target (PBGENE-LLY2) and one CNS-directed target (PBGENE-LLY3).

    Dr. Jantz continued, "The versatility of our platform offers us the optionality to pursue numerous therapeutic applications through strategic partnerships, enabling us to capture more of the value of the ARCUS technology and accelerate key programs. For example, in addition to rapidly advancing PBGENE-PCSK9 to the clinic, iECURE will provide critical validation of ARCUS' gene-insertion capabilities. Lilly will help us research ARCUS-mediated editing in muscle and CNS. Even as we aggressively invest in wholly-owned programs, we will continue to leverage collaborations that enable us to explore novel applications of ARCUS and reach patients quicker."

    The Company's balance of cash and cash equivalents is approximately $167 million as of August 31, 2021. The Company continues to expect that existing cash and cash equivalents will be sufficient to fund planned operations into 2023.

    Call and Webcast Information

    Precision's gene editing R&D event is being held today, September 9, 2021, at 8:00 a.m. ET. The dial-in conference call numbers for domestic and international callers are (866) 970-2058 and (873) 415-0216, respectively. The conference ID number for the call is 6376435. Participants may also access the live webcast, including slides, available in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precision's website for one year following the presentation.

    About ARCUS

    ARCUS® is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock in), remove (knockout), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA. Precision's platform and products are protected by a comprehensive portfolio including more than 80 patents to date.

    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.

    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 further development and potential of our ARCUS platform, the clinical development and timeline of PBGENE-PCSK9, PBGENE-PH1 and PBGENEHBV, our agreement with iECURE and the potential clinical development and benefits thereunder, our agreement with Lilly and the potential clinical development and benefits thereunder, and our expected use of cash and cash equivalents. In some cases, you can identify forward-looking statements by terms such as "aim," "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "target," "mission," "goal," "may," "will," "would," "should," "could," "target," "potential," "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 and effects of restrictions thereunder; risks associated with raising additional capital; 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 limited ability or inability to assess the safety and efficacy of our product candidates; 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 obtain an adequate supply of T cells from qualified donors; our ability to achieve our anticipated operating efficiencies at our manufacturing facility; delays or difficulties in our and our collaborators' ability to enroll patients; changes in interim "top-line" and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, 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 and reliance on 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 executives and personnel; market and economic conditions; effects of system failures and security breaches; 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, which are 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 have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

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  4. 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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  5. 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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