DTIL News & Events

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.

Precision BioSciences announced presentation of new preclinical study data supporting the potential long-term efficacy of PBGENE-DMD. The data presentation took place during a poster session at the Muscular Dystrophy Association Clinical & Scientific Conference 2026 currently taking place in Orlando, Florida. In new data from a GLP study conducted in a humanized DMD mouse model which replicates muscle degeneration observed in patients with DMD, PBGENE-DMD treatment led to improvements in numerous markers of muscle damage, including Alanine Aminotransferase, Aspartate Aminotransferase, and Creatine Kinase. At 90 days after administration of PBGENE-DMD, treatment resulted in a approximately 50%-65% reduction in CK levels, indicating substantial muscle integrity improvements. Furthermore, results showed improvements in muscle pathology assessments with lower composite injury scores across multiple muscle tissues compared to control vehicle-treated mice. Together, these data support PBGENE-DMD's differentiated profile as a gene editing therapy designed to potentially treat up to 60% of DMD patients by restoring production of a near full-length, functional dystrophin protein through permanent gene correction.

Precision BioSciences announced that the FDA has granted fast track designation to PBGENE-DMD for the treatment of Duchenne muscular dystrophy. The company also announced that it will host a virtual key opinion leader event on Tuesday, March 17 at 9:00 AM ET to discuss PBGENE-DMD and the planned Phase 1/2 FUNCTION-DMD clinical study.