DTIL Precision BioSciences Inc.

12.3
-0.57  -4%
Previous Close 12.87
Open 12.79
52 Week Low 4.455
52 Week High 16.6
Market Cap $691,784,706
Shares 56,242,659
Float 50,057,750
Enterprise Value $579,478,201
Volume 474,810
Av. Daily Volume 1,225,379
Stock charts supplied by TradingView

Drug Pipeline

Drug Stage Notes
PBCAR269A
Multiple Myeloma
Phase 1/2
Phase 1/2
Phase 1/2a trial to commence 1H 2021.
PBCAR19B
Non-Hodgkin Lymphoma (NHL)
Phase 1
Phase 1
Phase 1 trial to commence mid-2021.
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 data released December 4, 2020 - 11/16 ORR across multiple NHL cohorts. 4/11 ORR in B-ALL patients.
PBCAR20A
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)
Phase 1/2
Phase 1/2
Phase 1/2 initiation of dosing announced April 7, 2020.
PBCAR269A
Multiple myeloma
Phase 1/2
Phase 1/2
Phase 1/2 dosing of first patient announced June 8, 2020.

Latest News

  1. DURHAM, N.C., March 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, today announced management will participate in the following upcoming virtual investor conferences:

    H.C. Wainwright Global Life Sciences Conference
    Date: Tuesday, March 9, 2021
    The fireside chat will be available on demand beginning at 7:00 AM ET with an archived replay available for 90 days.

    Barclays Global Healthcare Conference
    Date: Tuesday, March 9, 2021
    Presentation: 10:55 AM ET
    An archived replay of this corporate presentation will be available for one year.

    Webcasts will be accessible on the…

    DURHAM, N.C., March 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, today announced management will participate in the following upcoming virtual investor conferences:

    H.C. Wainwright Global Life Sciences Conference

    Date: Tuesday, March 9, 2021

    The fireside chat will be available on demand beginning at 7:00 AM ET with an archived replay available for 90 days.

    Barclays Global Healthcare Conference

    Date: Tuesday, March 9, 2021

    Presentation: 10:55 AM ET

    An archived replay of this corporate presentation will be available for one year.

    Webcasts will be accessible on the Company's website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations.

    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.

    Investor Contact:

    Alex Kelly

    Interim Chief Financial Officer

    Media Contact:

    Maurissa Messier

    Senior Director, Corporate Communications

     



    Primary Logo

    View Full Article Hide Full Article
  2. DURHAM, N.C., Feb. 19, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL) a clinical stage biotechnology company, today announced the publication of a paper in Molecular Therapy describing three-year follow-up data showing long-term stable reduction of low-density lipoprotein (LDL) cholesterol levels in nonhuman primates (NHPs) following in vivo gene editing of the PCSK9 gene with its proprietary ARCUS® genome editing platform.

    The study, "Long-term Stable Reduction of Low-density Lipoprotein in Nonhuman Primates Following In Vivo Genome Editing of PCSK9" was published online in Molecular Therapy and was led by James M. Wilson, M.D., Ph.D., a professor of Medicine and director of the Penn Gene Therapy Program and the Penn…

    DURHAM, N.C., Feb. 19, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL) a clinical stage biotechnology company, today announced the publication of a paper in Molecular Therapy describing three-year follow-up data showing long-term stable reduction of low-density lipoprotein (LDL) cholesterol levels in nonhuman primates (NHPs) following in vivo gene editing of the PCSK9 gene with its proprietary ARCUS® genome editing platform.

    The study, "Long-term Stable Reduction of Low-density Lipoprotein in Nonhuman Primates Following In Vivo Genome Editing of PCSK9" was published online in Molecular Therapy and was led by James M. Wilson, M.D., Ph.D., a professor of Medicine and director of the Penn Gene Therapy Program and the Penn Orphan Disease Center, and Lili Wang, Ph.D., a research director in the Penn Gene Therapy Program and research associate professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania.

    "Building on the work we previously published in Nature Biotechnology in 2018, which was the first demonstrated use of any gene editing technology to create a clinically relevant reduction of gene expression of the PCSK9 protein in nonhuman primates, these latest pre-clinical results showed that targeted in vivo gene disruption with ARCUS has had a lasting therapeutic effect after a single dose, and provide pivotal data for safety considerations that support advancement towards clinical translation," said Dr. Wilson. "These results not only contribute to the growing evidence of gene editing for potential therapeutic use, but specifically showed that ARCUS nuclease gene editing could be a very promising new approach leading to treatments for heart disease patients that do not tolerate commonly used PCSK9 inhibitors."

    Researchers at the University of Pennsylvania delivered a gene encoding an ARCUS nuclease by adeno-associated virus (AAV) to inactivate the PCSK9 gene and inhibit protein expression, which would normally prevent receptors from removing excess LDL (or "bad" cholesterol) in the liver. NHPs have been monitored for more than three years and have continued to show a sustained reduction in LDL cholesterol levels while maintaining stable gene editing without any obvious adverse effects. After the one-time vector administration more than three years ago, NHPs treated with ARCUS have experienced stable reductions of up to 85% in PCSK9 protein levels and a 56% reduction of LDL cholesterol levels.

    "To our knowledge, this is the longest duration gene editing data in a large animal model. The data demonstrates that a single administration of an ARCUS nuclease could represent a potential one-time, permanent treatment for familial hypercholesteremia," commented Derek Jantz, Ph.D., co-author of the paper and Chief Scientific Officer at Precision BioSciences. "ARCUS has attributes that we believe significantly differentiate it from RNAi or conventional AAV gene therapy approaches, as well as CRISPR gene editing approaches. At more than three years out, we are seeing a stable gene edit that is being inherited by subsequent generations of hepatocytes, and evidence thus far supports that this is a permanent change. We look forward to continued monitoring of these animals and applying these learnings to our other in vivo gene editing programs."

    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 (knock-out), 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 70 patents to date.

    About Precision BioSciences, Inc.

    Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its wholly 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 potential results, uses and advancement of our in vivo gene editing programs and ARCUS-based gene editing technology, including, without limitation, its differentiating attributes and effects upon the PCSK9 gene, LDL cholesterol levels and familial hypercholesteremia. 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 September 30, 2020, 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.

    Investor Contact:

    Alex Kelly

    Interim Chief Financial Officer

    Media Contact:

    Maurissa Messier

    Senior Director, Corporate Communications



    Primary Logo

    View Full Article Hide Full Article
  3. DURHAM, N.C., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL) a clinical stage biotechnology company dedicated to improving life with its proprietary ARCUS® genome editing platform, today announced it will participate in the Guggenheim Healthcare Talks 2021 Oncology Day on February 11, 2021 at 2:00 PM ET.

    A live webcast of the presentation will be accessible on the Company's website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations. An archived replay of the webcasts will be available for approximately 30 days following the presentation.

    About Precision BioSciences, Inc.
    Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life…

    DURHAM, N.C., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL) a clinical stage biotechnology company dedicated to improving life with its proprietary ARCUS® genome editing platform, today announced it will participate in the Guggenheim Healthcare Talks 2021 Oncology Day on February 11, 2021 at 2:00 PM ET.

    A live webcast of the presentation will be accessible on the Company's website, www.precisionbiosciences.com, in the Investors & Media section under Events and Presentations. An archived replay of the webcasts will be available for approximately 30 days following the presentation.

    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.

    Investor Contact:

    Alex Kelly

    Interim Chief Financial Officer

    Media Contact:

    Maurissa Messier

    Senior Director, Corporate Communications

     



    Primary Logo

    View Full Article Hide Full Article
  4. DURHAM, N.C., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL) a clinical stage biotechnology company dedicated to improving life with its wholly proprietary ARCUS® genome editing platform, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin Lymphoma (NHL).

    The allowed composition claims of U.S. Patent Application No. 16/908,030 encompass genetically-modified human T cells comprising the Company's PBCAR19B construct, which is inserted within the T cell receptor alpha constant (TRAC) locus. Once issued, patents arising…

    DURHAM, N.C., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL) a clinical stage biotechnology company dedicated to improving life with its wholly proprietary ARCUS® genome editing platform, today announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin Lymphoma (NHL).

    The allowed composition claims of U.S. Patent Application No. 16/908,030 encompass genetically-modified human T cells comprising the Company's PBCAR19B construct, which is inserted within the T cell receptor alpha constant (TRAC) locus. Once issued, patents arising from this patent family will have standard expiration dates in April 2040.

    "This patent, when issued, will cover important design elements of our PBCAR19B stealth cell candidate, which is engineered to knock down expression of beta-2 microglobulin to reduce killing of CAR T cells by cytotoxic T cells, and to reduce CAR T cell rejection by natural killer cells," said Derek Jantz, Ph.D., Chief Scientific Officer and Co-Founder of Precision BioSciences. "Additionally, PBCAR19B CAR T cells are generated using a single gene editing step by inserting one cassette, encoding all the necessary elements, into the TRAC locus. Not only will this patent strengthen our intellectual property portfolio, it will further distinguish our ARCUS-based allogeneic CAR T development approach."

    About PBCAR19B

    PBCAR19B is a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as relapsed/refractory Non-Hodgkin Lymphoma. PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by reducing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the stealth vector includes a short hairpin RNA (shRNA) that suppresses expression of beta-2 microglobulin (B2M), a component of Class 1 major histocompatibility complex (MHC) molecules found on the cell surface. Reducing or knocking down Class 1 MHC expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The stealth vector also carries an HLA-E gene intended to reduce rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface. The U.S. Food and Drug Administration has accepted the Investigational New Drug application for PBCAR19B, and the Phase 1 clinical study is expected to begin by mid-2021. 

    About Precision BioSciences, Inc.

    Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its wholly 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 Precision's Collaboration with Servier

    Under the terms of the agreement with Servier, Precision is solely responsible for early-stage research activities as well as PBCAR0191 Phase 1/2a and PBCAR19B Phase 1 clinical trial execution and clinical supply. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.

    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 expected commencement of a Phase 1 clinical trial for PBCAR19B, expected results from clinical trials involving PBCAR19B, and our patent portfolio and ARCUS-based allogeneic CAR T development approach. 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 September 30, 2020, 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.

    Investor Contact:

    Alex Kelly

    Interim Chief Financial Officer

    Media Contact:

    Maurissa Messier

    Senior Director, Corporate Communications



    Primary Logo

    View Full Article Hide Full Article
  5. DURHAM, N.C., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage biotechnology company dedicated to improving life with its wholly proprietary ARCUS® genome editing platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin Lymphoma (NHL).

    "We are pleased to receive IND clearance for PBCAR19B, which has shown in preclinical studies, to delay both T cell and natural killer cell-mediated allogeneic rejection," said Matt Kane, Chief Executive Officer of Precision BioSciences. "We believe that the ability…

    DURHAM, N.C., Jan. 19, 2021 (GLOBE NEWSWIRE) -- Precision BioSciences, Inc. (NASDAQ:DTIL), a clinical stage biotechnology company dedicated to improving life with its wholly proprietary ARCUS® genome editing platform, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory (R/R) Non-Hodgkin Lymphoma (NHL).

    "We are pleased to receive IND clearance for PBCAR19B, which has shown in preclinical studies, to delay both T cell and natural killer cell-mediated allogeneic rejection," said Matt Kane, Chief Executive Officer of Precision BioSciences. "We believe that the ability to reduce rejection by both cell types holds potential for improved persistence of allogeneic CAR T cells and that, by bringing PBCAR19B into the clinic while continuing to develop our lead allogenic candidate PBCAR0191, we have two opportunities to achieve our goal of producing deep and durable clinical responses."

    The Phase 1 study will be a non-randomized, open-label, single-dose, dose-escalation and dose-expansion study deigned to evaluate the safety and clinical activity of PBCAR19B at increasing flat dose levels (2.7 x 108 - 8.1 x 108 CAR T cells) in patients with R/R NHL. The primary objective of the study is to identify the maximum tolerated dose and any dose-limiting toxicities.

    About PBCAR19B

    PBCAR19B is a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as relapsed/refractory Non-Hodgkin Lymphoma. PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by preventing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the stealth vector carries a short hairpin RNA (shRNA) that suppresses expression of beta-2 microglobulin (B2M), a component of Class 1 major histocompatibility complex (MHC) molecules found on the cell surface. Reducing or knocking down Class 1 expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The stealth vector also carries a HLA-E gene intended to prevent rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface.

    About Precision BioSciences, Inc.

    Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its wholly 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 Precision's Collaboration with Servier

    Under the terms of the agreement with Servier, Precision is solely responsible for early-stage research activities as well as PBCAR0191 and PBCAR19B Phase 1/2a clinical trial execution and clinical supply. Servier has the exclusive right to opt in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the United States.

    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 expected commencement of a Phase 1 clinical trial for PBCAR19B and expected results from clinical trials involving PBCAR19B and PBCAR0191. 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 September 30, 2020, 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.

    Investor Contact:

    Alex Kelly

    Interim Chief Financial Officer

    Media Contact:

    Maurissa Messier

    Senior Director, Corporate Communications



    Primary Logo

    View Full Article Hide Full Article
View All Precision BioSciences Inc. News