Precision BioSciences to Host Virtual Investor Event Highlighting PBGENE-HBV Preclinical Safety Data and Phase 1 Clinical Trial Plans on November 15, 2024

Rhea-AI Summary

Precision BioSciences (Nasdaq: DTIL) announced a virtual Hepatitis B Investor Event scheduled for November 15, 2024. The event will feature Key Opinion Leaders and members of Precision's Hepatitis Scientific Advisory Board discussing the current hepatitis B treatment landscape, which only achieves 1-3% functional cure rates. The presentation will focus on PBGENE-HBV, their gene editing approach targeting cccDNA elimination and HBV DNA inactivation. The company will present final preclinical safety data and phase 1 clinical trial plans following Clinical Trial Application approval in Moldova.

Positive

• Received Clinical Trial Application approval in Moldova for PBGENE-HBV
• Additional global regulatory approvals are pending
• Advancing to Phase 1 clinical trials with PBGENE-HBV

Negative

• None.

DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, today announced it will host a Hepatitis B Investor Event on Friday, November 15, 2024, from 7:00 a.m. – 8:30 a.m. PST prior to the American Association for the Study of Liver Diseases (AASLD) Meeting.

The event will feature Key Opinion Leaders in the field of Hepatitis and members of Precision’s Hepatitis Scientific Advisory Board, who will join to discuss their perspectives on the current unmet need and treatment landscape for chronic hepatitis B that unfortunately only results in 1-3% of patients achieving a functional cure. The discussion will include a deeper dive into the PBGENE-HBV gene editing approach that is uniquely designed to target the root cause of disease by eliminating cccDNA and inactivating integrated HBV DNA. In addition, members of Precision BioSciences’ executive management team will highlight final PBGENE-HBV preclinical safety data and phase 1 clinical trial plans now that Precision has received Clinical Trial Application approval in Moldova with other global regulatory approvals pending.

Investor Event Webcast Presentation and Registration Information

The event will be webcasted live on Friday, November 15, 2024, at 10:00 am EST (7:00 a.m. PST). To access the presentation and webcast, please use the following link or go to Precision’s website in the Investors section under Events & Presentations at investor.precisionbiosciences.com. An archived replay of the webcast will be available following the event.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company’s pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.

The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into a gene to cause expression/add function), elimination (removing a genome, e.g., viral DNA or mutant mitochondrial DNA), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV).

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 safety, efficacy and benefit of our product candidates (including PBGENE-HBV); the unique design of PBGENE-HBV to directly eliminate cccDNA and inactivate integrated HBV DNA with high specificity, potentially leading to functional cures or providing a better chance of functional cures; the expected timing of regulatory processes (including filings such as IND’s and CTA’s and studies for PBGENE-HBV and the acceptance of these filings by regulatory agencies), the suitability of PBGENE-HBV for the treatment of hepatitis and the targeting of the root cause of the disease, expectations about operational initiatives, strategies, and further development of PBGENE-HBV; expectations about achievement of key milestones; and anticipated timing of clinical data. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “design”, “designed,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “strive,” “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. These statements are neither promises nor guarantees, and involve 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 to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and 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; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators’ or other licensees’ ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators’ or other licensees’ development of product candidates; our or our collaborators’ or other licensees’ ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators’ and other licensees’ 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; our or our licensees’ ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators’ or other licensees’ 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; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license 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; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; 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, 2024, 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 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/20241028524986/en/

Investor and Media Contact:

Naresh Tanna

Vice President of Investor Relations

naresh.tanna@precisionbiosciences.com

Source: Precision BioSciences, Inc.

FAQ

When will Precision BioSciences (DTIL) host its Hepatitis B Investor Event?

Precision BioSciences will host its Hepatitis B Investor Event on November 15, 2024, from 7:00 a.m. to 8:30 a.m. PST.

What is the current functional cure rate for chronic hepatitis B treatments discussed in DTIL's presentation?

According to the presentation, current hepatitis B treatments only result in 1-3% of patients achieving a functional cure.

Where has DTIL received Clinical Trial Application approval for PBGENE-HBV?

Precision BioSciences has received Clinical Trial Application approval in Moldova for PBGENE-HBV.

What is the mechanism of action for DTIL's PBGENE-HBV treatment?

PBGENE-HBV is designed to target the root cause of disease by eliminating cccDNA and inactivating integrated HBV DNA.