PRECISION BIOSCIENCES INC 8-K

What Happened

• On May 27, 2026, Precision BioSciences (DTIL) filed an 8-K and issued a press release (Exhibit 99.1) announcing new biopsy and clinical data for PBGENE‑HBV from the ongoing Phase 1 ELIMINATE‑B trial, presented as a late-breaker at the EASL Congress 2026 in Barcelona. The company hosted a live investor webcast the same day at 8:00 a.m. ET (materials at https://investor.precisionbiosciences.com/events-and-presentations).

Key Details

• New biopsy data: PBGENE‑HBV demonstrated direct elimination of cccDNA, producing a 1‑log (10‑fold) reduction in cccDNA‑derived transcripts.
• Biomarker result: pgRNA was shown to directly reflect cccDNA elimination; PBGENE‑HBV achieved loss of detectable blood pgRNA in 100% of patients (6/6) with pgRNA detectable at baseline, with blood pgRNA loss matching undetectable pgRNA in post‑treatment liver biopsies.
• Safety and dosing: As of data cutoff, 38 doses administered across 16 patients in 5 dose cohorts for the safety analysis; no dose‑limiting toxicities observed. Most common adverse events were infusion‑related reactions (LNP effects) resolving within 24 hours. Transient ≥Grade 3 ALT/AST abnormalities were asymptomatic, with no bilirubin elevation and no Hy’s law cases. One patient in the highest cohort (0.8 mg/kg) had two SAEs after a second LNP dose; one SAE was treatment‑related and linked to hypotension.
• Mitigation: The hypotension mechanism was identified; measures (slower infusion rate, increased steroids) implemented. Up to 20% of doses have been given under the mitigation protocol, and no ≥Grade 3 hypotension or ≥Grade 3 LNP‑related ALT/AST events have been observed since.

Why It Matters

• These results address two key investor concerns for HBV therapies: direct impact on intrahepatic cccDNA (the viral reservoir) and a measurable blood biomarker (pgRNA) that correlated with liver biopsy findings—both improve confidence in the ability to assess drug effect.
• Safety data show a manageable profile with identified mitigation steps; however, the filing highlights specific prior serious events and ongoing monitoring — important context for clinical and regulatory risk assessment.
• Investors should note this disclosure contains forward‑looking statements and that these are early Phase 1 results (small patient numbers); further data and larger studies will be needed to confirm efficacy and safety.