Precision BioSciences Announces Data Presentation on Effective Cell Dose and Functional Attributes of CD19 Allogeneic CAR T, Azer-Cel, at the Upcoming 2022 American Society of Hematology (ASH) Annual Meeting

Rhea-AI Summary

Precision BioSciences (Nasdaq: DTIL) announced an accepted abstract for poster presentation at the 64th American Society of Hematology Annual Meeting in New Orleans from December 10-13, 2022. The poster will detail the effective cell dose and functional attributes of its lead CD19 candidate, Azercabtagene Zapreleucel (azer-cel), in treating relapsed or refractory non-Hodgkin lymphoma. This analysis highlights the product's composition and cell doses, which may improve safety and efficacy. Dr. Alan List emphasized the significance of maximizing naïve cell phenotype in allogeneic CAR T therapy.

Positive

• Abstract on azer-cel accepted for presentation at a major conference, indicating scientific interest.
• Potential improvement in safety and efficacy of azer-cel due to optimized product attributes.
• First analysis of an allogeneic CD19 CAR T product composition showcasing innovative strategies.

Negative

• No financial metrics or immediate market impact provided, suggesting potential uncertainty in future performance.

DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced that an abstract on the effective cell dose and functional attributes of the company’s lead CD19 candidate, Azercabtagene Zapreleucel (azer-cel) was accepted for poster presentation at the 64^th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 10-13, 2022 in New Orleans, Louisiana. Precision is currently evaluating azer-cel in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) who relapsed following treatment with an autologous CAR T.

“We look forward to seeing this data presented at the ASH meeting and highlighting the differentiated product cellular attributes including product composition and cell doses that contribute to optimized efficacy and safety of azer-cel. This is the first analysis of an allogeneic CD19 CAR T product composition to demonstrate that strategies to maximize naïve cell phenotype may lead to improved safety and efficacy of an allogenic CAR T therapy,” said Alan List, M.D., Chief Medical Officer of Precision BioSciences.

Poster Presentation Details:

Title: Effective Cell Dose and Functional Attributes of Azercabtagene Zapreleucel (azer-cel; PBCAR0191) Associate with Allogeneic CAR T-Cell Safety and Efficacy in Patients with Relapsed/Refractory B-Cell Lymphoma
First Author: Caron A. Jacobson, M.D., Dana Farber Cancer Institute
Poster Session: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I
Abstract #: 2005
Date/Time: Saturday, December 10, 2022, 5:30 PM – 7: 30 PM ET
Location: Ernest N. Morial Convention Center, Hall D

The abstract accepted for poster presentation is now available at www.hematology.org.

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 precise 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 ex vivo “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene editing candidates designed 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 clinical development and expected efficacy and benefit of our product candidates, benefits of ARCUS and potential expansion and development using ARCUS, differentiated product attributes including product composition and cell doses, optimized efficacy and safety, and strategies to preserve naïve cell phenotype. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” 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 studies and clinical trials; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and 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 COVID-19 pandemic and variants thereof, 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, 2022, as any such factors may be updated from time to time in our other filings with the SEC, including, but not limited to, our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022, to be filed with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221103005817/en/

Investor Contact:

Alex Kelly

Chief Financial Officer

Alex.Kelly@precisionbiosciences.com

Media Contact:

Maurissa Messier

Senior Director, Corporate Communications

Maurissa.Messier@precisionbiosciences.com

Source: Precision BioSciences, Inc.

FAQ

What is the significance of the azer-cel presentation at the ASH Annual Meeting?

The presentation highlights the effective cell dose and functional attributes of azer-cel, suggesting potential improvements in treatment outcomes for non-Hodgkin lymphoma.

When is the azer-cel poster presentation taking place?

The poster presentation is scheduled for December 10, 2022, from 5:30 PM to 7:30 PM ET.

What are the key findings to be presented about azer-cel?

The findings focus on product composition and cell doses that may enhance the safety and efficacy of azer-cel in treating relapsed or refractory non-Hodgkin lymphoma.