DTIL News & Events

Precision BioSciences announced that it has received Clinical Trial Application, CTA, approval to expand the ongoing global Eliminate-B clinical trial of PBGENE-HBV. The regulatory authorization will allow Precision to initiate important hepatitis B clinical trial sites in France and Romania. This expansion broadens the trial's global footprint deeper into Europe, adding to existing clinical trial sites in the United Kingdom, Moldova, New Zealand, Hong Kong and the United States. The Company expects the addition of clinical trial sites in France and Romania to support continued patient enrollment and clinical execution in Eliminate-B with the goal to treat as many clinical trial patients as possible with PBGENE-HBV. Site initiation activities are underway, with initial patient screening expected in Q2 2026.

Reports Q4 revenue $34.2M, consensus $9.07M. The increase of $33.6M in revenue during the quarter ended December 31, 2025 was primarily the result of recognizing $26.2M in revenue under the Novartis agreement following conclusion of the hemoglobinopathy collaboration in October 2025 and recognition of $8M in revenue under the Imugene license agreement. "2025 was an exceptional year for Precision BioSciences marked by meaningful clinical and financial progress. We delivered on what we committed to achieve and more in 2025 positioning Precision BioSciences for success in 2026 and beyond," said Michael Amoroso, Chief Executive Officer. "The evidence supporting the clinical utility of ARCUS for in vivo gene editing continues to mount in diseases with high unmet need led by advancement of PBGENE-HBV through multiple cohorts in our ELIMINATE-B study for chronic hepatitis B. At The Liver Meeting(R) 2025, we presented late-breaking clinical data showing safety and cumulative, dose-dependent antiviral activity along with paired biopsy findings that provide the first molecular evidence consistent with viral DNA gene editing in patients. In another first, our partner iECURE achieved a complete response in the first infant with neonatal onset OTC deficiency following treatment with ECUR-506 which utilizes an ARCUS nuclease developed by Precision for in vivo gene insertion."

Precision BioSciences announced that it has received two notices of allowance from the U.S. Patent and Trademark Office, or USPTO, for patent applications relating to the company's PBGENE-HBV program. The '136 application includes composition of matter claims that, when granted, will encompass the Arcus nuclease utilized in PBGENE-HBV. The '982 application includes composition of matter claims that, when granted, will encompass any polypeptide-including the PBGENE-HBV Arcus nuclease-that comprises a novel, shortened polypeptide linker developed by Precision. Future Arcus nucleases incorporating this novel polypeptide linker will also be covered by the granted claims.