DURHAM, N.C. - Precision BioSciences, Inc. (NASDAQ: NASDAQ:DTIL), a clinical stage gene editing company currently trading near its 52-week low but showing promising financial health according to InvestingPro analysis, has announced the approval of its Clinical Trial Application (CTA) in Hong Kong for PBGENE-HBV, marking a significant milestone in the development of in vivo gene editing therapies. The company maintains a strong balance sheet with more cash than debt and a healthy current ratio of 9.22. This approval enables the company to extend its ELIMINATE-B Phase I trial to Hong Kong, targeting chronic hepatitis B (HBV) by aiming to eliminate the virus's persistent genetic material in liver cells.
The ELIMINATE-B study is currently recruiting patients in Moldova and will now include a prominent infectious disease clinical site in Hong Kong. This trial is part of Precision’s strategy to expand its clinical and regulatory operations globally. Dr. Murray Abramson, Senior Vice President, Head of Clinical Development at Precision BioSciences, expressed optimism about the potential of PBGENE-HBV to treat a broad range of HBV genotypes, including those prevalent in Asia.
Hong Kong has over 400,000 individuals living with chronic hepatitis B, many of whom develop serious conditions like liver cancer or cirrhosis despite existing treatments. By targeting and eliminating covalently closed circular DNA, the root cause of HBV, PBGENE-HBV could significantly alter the treatment landscape. Dr. MF Yuen from The University of Hong Kong highlighted the industry's long-standing quest to eradicate the root cause of chronic HBV and his eagerness to further investigate PBGENE-HBV's potential in clinical settings.
PBGENE-HBV leverages the ARCUS gene editing platform, which employs a compact and precise gene editing tool to target the HBV viral genome. This therapeutic approach aims to provide functional cures for patients with chronic HBV infection by eliminating cccDNA and inactivating integrated HBV DNA.
Precision BioSciences is on track for a U.S. investigational new drug (IND) application in 2025 and will continue to submit clinical trial applications globally as part of its Phase 1 regulatory strategy for PBGENE-HBV. The company plans to share clinical data as it becomes available throughout 2025.
Hepatitis B remains a significant global health challenge with no current curative options, affecting an estimated 300 million people worldwide. Current treatments focus on long-term viral suppression but do not eradicate the virus, necessitating lifelong administration.
Precision BioSciences is dedicated to improving lives through its ARCUS platform, which differentiates itself by the way it cuts DNA, its smaller size, and simpler structure. The company's pipeline includes in vivo gene editing candidates designed to provide lasting cures for a broad range of genetic and infectious diseases. With a market capitalization of $35.13 million and revenue growth of 43.62% in the last twelve months, the company shows promising financial momentum. InvestingPro analysis indicates the stock may be undervalued at current levels, presenting a potential opportunity for investors seeking exposure to the gene editing sector.
This report is based on a press release statement from Precision BioSciences, Inc.
In other recent news, Precision BioSciences has been making strides in gene-editing technology. The company recently maintained its Market Perform rating and $34 target from BMO Capital. The firm's third-quarter earnings report focused on the clinical development of PBGENE-HBV, which received Clinical Trial Application (CTA) approval recently. Clinical data for this program is expected in 2025.
Precision BioSciences has initiated a Phase 1 clinical trial for PBGENE-HBV, a potential cure for chronic hepatitis B. The company has also reshuffled its clinical leadership team, appointing Dr. Murray Abramson as Senior Vice President, Head of Clinical Development, and John Fry as Strategic Clinical Advisor.
Furthermore, the company has received a $13 million convertible note payment from Imugene Limited, strengthening its financial resources. The company's collaborator, iECURE, received FDA Fast Track designation for its gene therapy candidate ECUR-506. Precision BioSciences has also submitted additional Clinical Trial Applications as part of its global strategy for PBGENE-HBV. These recent developments are part of the company's ongoing efforts to advance gene editing therapies.
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