DURHAM, N.C. - Precision BioSciences, Inc. (NASDAQ: NASDAQ:DTIL), a leader in gene editing technology, has announced the submission of Clinical Trial Applications (CTA) to begin a Phase 1 study for PBGENE-HBV, a pioneering in vivo gene editing therapy aimed at potentially curing chronic hepatitis B. This marks a significant step for the company, which is leveraging its proprietary ARCUS platform to develop gene editing treatments for a range of diseases.
The CTA submissions represent a critical milestone for Precision BioSciences as it seeks to address one of the world's most prevalent public health issues. According to the World Health Organization, an estimated 300 million people are afflicted with chronic hepatitis B globally. The company's CEO, Michael Amoroso, emphasized the dedication of the Precision team and the importance of the regulatory submissions as they move towards the clinical stage of development for chronic hepatitis B.
PBGENE-HBV is designed to eliminate cccDNA, the key source of hepatitis B virus replication, and inactivate integrated HBV DNA in hepatocytes. Dr. Murray Abramson, Senior Vice President, Head of Clinical Development, pointed out that current treatments offer only a 1-3% chance of a functional cure for patients with chronic hepatitis B, highlighting the potential impact of PBGENE-HBV.
Precision BioSciences is planning to share final clinical candidate safety data and details of the Phase 1 trial in November, prior to the American Association for the Study of Liver Diseases meeting. The company is also on track to submit additional regulatory applications as part of its global strategy for PBGENE-HBV, with more updates expected before the AASLD Annual Meeting in November.
Hepatitis B remains a significant cause of morbidity in the U.S. and death globally, with complications such as cirrhosis, liver failure, or liver cancer accounting for the majority of HBV-related deaths. PBGENE-HBV's approach to directly eliminate cccDNA and inactivate integrated HBV DNA could potentially lead to functional cures, providing a new hope for patients with chronic hepatitis B.
The information in this article is based on a press release statement.
In other recent news, Precision BioSciences, a gene editing company, has announced significant changes to its clinical leadership team and received a $13 million convertible note payment from Imugene Limited. The company's reshuffling aims to enhance its infectious disease and hepatitis programs, with Dr. Murray Abramson appointed as Senior Vice President, Head of Clinical Development. Concurrently, John Fry has been named Strategic Clinical Advisor, focusing on hepatitis. These developments are part of Precision BioSciences' strategic efforts to advance its gene editing therapies.
Precision BioSciences has also been added to the Russell Microcap Index, a move that CEO Michael Amoroso believes will enhance visibility among global investors. The company has shown progress in its hepatitis B treatment, revealing promising preclinical data for its PBGENE-HBV candidate. Furthermore, Precision BioSciences recently completed a private stock sale to its senior leadership team, raising $300,000 to fund ongoing research and development efforts.
In partnership news, Precision BioSciences' collaborator, iECURE, received FDA Fast Track designation for its gene therapy candidate ECUR-506. These are the latest developments in Precision BioSciences' ongoing efforts to advance gene editing therapies.
InvestingPro Insights
As Precision BioSciences (NASDAQ: DTIL) advances its innovative PBGENE-HBV therapy towards clinical trials, investors may find additional context from InvestingPro's financial metrics and tips.
According to InvestingPro data, Precision BioSciences has a market capitalization of $65.47 million, reflecting its position as a smaller player in the biotechnology sector. The company's revenue growth is noteworthy, with a 152.15% increase in quarterly revenue as of Q2 2024, indicating strong momentum in its operations.
An InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, which could be crucial for funding its upcoming clinical trials and research activities. This financial stability is particularly important as the company moves into the resource-intensive clinical phase for PBGENE-HBV.
Another relevant InvestingPro Tip notes that Precision BioSciences is profitable over the last twelve months, with a P/E ratio of 2.67. This profitability could provide some financial cushion as the company invests in its hepatitis B therapy development.
However, investors should be aware that the stock price has seen volatility, with a 16.82% decline over the past month. This volatility may reflect the inherent risks associated with biotechnology companies advancing novel therapies through regulatory processes.
For those interested in a deeper analysis, InvestingPro offers 6 additional tips that could provide further insights into Precision BioSciences' financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.