Precision BioSciences, Inc. filed a Form 8-K with the SEC on November 5, 2026, disclosing clinical trial updates for its PBGENE-HBV and PBGENE-DMD programs, including the advancement of the ELIMINATE-B study to Phase 2 and an eight-week safety observation for the first FUNCTION-DMD patient.

Key Highlights

  • Phase 1 ELIMINATE-B study advancing to Phase 2: As of the September 28, 2026 data cutoff, 25 patients received a total of 59 administrations of PBGENE-HBV across four dose levels, according to the filing.
  • Undetectable pgRNA at go-forward dose: The filing reports undetectable pgRNA was achieved in 100% of evaluable patients at the 0.4 mg/kg dose level.
  • cccDNA reductions confirmed in liver biopsies: Reproducible liver biopsy findings showed 1-log to 1.5-log reductions in cccDNA at the 0.4 mg/kg dose across multiple patients, the filing states.
  • HBsAg reductions in all evaluable patients: The filing discloses that maximal HBsAg reductions approached 94% at the 0.4 mg/kg dose, with treatment effect observed in 100% of evaluable patients.
  • No dose-limiting toxicities at go-forward dose: According to the filing, PBGENE-HBV demonstrated no dose-limiting toxicities and no serious adverse events at the 0.4 mg/kg go-forward dose across 59 administrations.
  • FUNCTION-DMD first patient clears eight-week observation: The filing reports the first patient dosed with PBGENE-DMD completed the eight-week observation period with no reported safety concerns, and the independent DSMB endorsed proceeding with dosing additional patients in Part 1.
  • Phase 2 combination therapy dosing expected Q1 2027: The company disclosed that dosing in the Phase 2 portion evaluating both monotherapy and combination therapy for chronic hepatitis B is expected to begin in the first quarter of 2027.

PBGENE-HBV Phase 1 Data and FUNCTION-DMD Safety Update from Precision BioSciences

Precision BioSciences, Inc. (NASDAQ:DTIL), headquartered in Durham, North Carolina, filed a current report under Item 7.01 and Item 8.01 on November 5, 2026 to disclose clinical trial updates for two programs. The filing describes PBGENE-HBV as "the first and only in vivo gene editing therapy designed to eliminate cccDNA, the root cause of chronic hepatitis B." The Phase 1 ELIMINATE-B study data, as of a September 28, 2026 cutoff, covered 25 patients who received 59 total administrations across four dose levels.

At the 0.4 mg/kg go-forward dose, the filing states that undetectable pgRNA was achieved in 100% of evaluable patients. One patient dosed at 0.65 mg/kg experienced a 95% reduction in pgRNA at the time of the data cutoff, with further assessment described as ongoing. Durable pgRNA loss was reported in 100% of patients who achieved undetectable pgRNA and had at least six months of follow-up. The filing also notes that the first HBeAg positive patient achieved 100% pgRNA loss from a baseline of 3.7-log copies/mL at the 0.4 mg/kg dose. The filing states the company will host a live webcast on November 9, 2026 at 8:00 a.m. Eastern Time to present late-breaking Phase 1 data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026.

Separately, the filing announces that the first patient dosed in the FUNCTION-DMD Phase 1/2 trial for Duchenne muscular dystrophy completed the eight-week post-treatment observation period with no reported safety concerns, including no serious adverse events or adverse events of special interest. The independent Data Safety Monitoring Board endorsed proceeding with dosing additional patients in Part 1 of that study. The filing notes that safety and efficacy updates from FUNCTION-DMD are expected throughout 2027. The filing specifies that statements about future clinical milestones are forward-looking and subject to risks described in the company's regulatory filings.

What Was Disclosed

Precision BioSciences filed a current report on November 5, 2026 providing Phase 1 ELIMINATE-B clinical data for PBGENE-HBV and a safety update for the first FUNCTION-DMD patient, alongside notice of an AASLD late-breaking oral presentation and an updated corporate deck.