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DURHAM, N.C. - Precision BioSciences (NASDAQ:DTIL), currently trading at $4.86 and considered undervalued according to InvestingPro analysis, announced Wednesday that its experimental gene editing therapy PBGENE-HBV showed promising early results in treating chronic hepatitis B, with substantial viral reductions observed in all patients in the lowest dose cohort of its ELIMINATE-B clinical trial. The company maintains a strong liquidity position with a current ratio of 6.62, though analysts expect sales to decline in the current year.
The therapy, designed to eliminate covalently closed circular DNA (cccDNA) and inactivate integrated viral DNA, demonstrated a favorable safety profile with no serious adverse events related to treatment in the initial cohort, where patients received 0.2 mg/kg doses.
All three patients in the first cohort showed significant reductions in hepatitis B surface antigen (HBsAg), with best responses ranging from 47% to 69%. One patient maintained approximately 50% reduction in HBsAg seven months after the initial dose, suggesting durability of response.
"This exciting dataset provides the first clinical evidence of substantial HBsAg reductions as a result of direct cccDNA elimination and/or inactivation of integrated HBV DNA in all patients, even at this lowest dose level," said Man-Fung Yuen, MBGENE-HBV investigator and Chair Professor at The University of Hong Kong.
The company has already begun dosing patients in the second cohort at 0.4 mg/kg, with initial safety data showing no dose-limiting toxicities. A third cohort is expected to begin dosing this month at a higher dose level.
Precision BioSciences also announced that Mark Sulkowski, Professor of Medicine at Johns Hopkins University School of Medicine, has expanded his role to become Head Clinical Development Advisor for the program.
The company has implemented cost-saving measures that it expects will extend its cash runway to the second half of 2027, providing sufficient funding to advance PBGENE-HBV to Phase 2 studies. With a market capitalization of $53.89 million and more cash than debt on its balance sheet, InvestingPro data shows the company’s overall financial health score as "GOOD," despite its rapid cash burn rate.
An estimated 300 million people worldwide have chronic hepatitis B infection, with current treatments requiring lifelong administration and rarely achieving functional cure.
The information in this article is based on a press release statement from Precision BioSciences.
In other recent news, Precision BioSciences has announced several significant developments concerning its gene editing treatment for Duchenne muscular dystrophy (DMD). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the company’s PBGENE-DMD treatment. This designation offers benefits such as financial incentives for clinical development and the potential for up to seven years of market exclusivity if the drug is approved. Additionally, Precision BioSciences’ DMD therapy has received Rare Pediatric Disease Designation from the FDA, highlighting its focus on serious diseases affecting a small number of young patients in the U.S. Furthermore, the company reported promising preclinical data showing a significant increase in dystrophin-positive muscle cells in a DMD mouse model. The results indicated up to a three-fold increase in dystrophin-positive cells in various muscle types, including the gastrocnemius, quadriceps, heart, and diaphragm. Precision BioSciences also received FDA Orphan Drug Designations for its nuclease treatments targeting DMD. These recent developments underscore the company’s progress in advancing its gene editing therapies for this rare genetic disorder.
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