Precision BioSciences Reports First Biopsy Proof of cccDNA Elimination
Liver biopsies in ELIMINATE-B showed a 1-log cccDNA drop with under 1% remaining after two PBGENE-HBV doses, and cash stood at $112.4 million at June 30.
Precision BioSciences, Inc. (DTIL), a clinical-stage gene-editing company, said liver biopsies from the ELIMINATE-B trial provided the first clinical evidence that a therapeutic agent can directly target and eliminate cccDNA in chronic hepatitis B, the root template for viral replication.
The company presented late-breaking data at the European Association for the Study of the Liver congress on May 27, 2026. The May 4 data cut covered 38 doses across 16 patients in five cohorts. In one patient, two administrations of PBGENE-HBV at 0.4 mg/kg produced a 1-log, or 10-fold, reduction in cccDNA-derived transcripts, with less than 1% of cccDNA remaining. A second patient who received three doses at the same level showed that repeat administrations cumulatively increase the anti-cccDNA effect.
Chief Executive Officer Michael Amoroso said the biopsy results validate both the science and the development strategy for PBGENE-HBV. PBGENE-HBV is the only clinical-stage program that targets and eliminates cccDNA, and the first in vivo gene-elimination approach to use repeat lipid-nanoparticle administrations in chronic hepatitis B.
In blood, pre-genomic RNA became durably undetectable in 100% of patients who had detectable pgRNA before treatment, with the loss ongoing for up to six months as of the cutoff. Substantial S-antigen declines were seen in 100% of treated patients across dose levels from 0.2 mg/kg to 0.8 mg/kg. No dose-limiting toxicities were observed in the 16 patients. LNP-related hypotension during dose escalation was identified and mitigated with a longer infusion and a short course of steroids.
Since the update, Precision opened new sites and is expanding cohorts 4 (0.4 mg/kg) and 5 (0.65 mg/kg), collecting more biopsies and biomarker data to inform a Part 2 dosing schedule. The company expects additional ELIMINATE-B updates by the end of 2026.
PBGENE-DMD, designed to excise exons 45-55 of the dystrophin gene in Duchenne muscular dystrophy, moved from one activated site in the first quarter to two active sites: Arkansas Children’s Hospital and Washington University School of Medicine. The Phase 1/2 FUNCTION-DMD trial is recruiting boys ages 2 to 7, with initial safety data expected by year-end 2026. New preclinical data in mice supported evaluating younger patients, including ages 2 to 3.
Revenue was zero for the quarter ended June 30, 2026, versus $18 thousand a year earlier from the Novartis agreement. Research and development expenses were $12.4 million, down from $12.8 million; the $0.4 million decrease reflected lower platform development and research costs, partly offset by higher PBGENE-DMD and PBGENE-HBV clinical spending. General and administrative expenses were $6.8 million, down from $9.1 million, reflecting operational discipline and lower employee-related costs.
Total other expense was $13.5 million, versus $1.6 million a year earlier, driven primarily by a $13.9 million non-cash loss on the change in fair value of the warrant liability after the stock price rose. Net loss was $32.7 million, or $(1.26) a share, versus $23.5 million, or $(2.13) a share, a year earlier. The wider net loss was driven by the warrant-liability fair-value loss and did not affect operating loss or cash runway. Operating loss was $19.2 million.
Cash, cash equivalents, and restricted cash were $112.4 million as of June 30, 2026, down from $125.8 million as of March 31, 2026. Existing cash, fiscal and operating discipline, and the at-the-market facility should fund a runway through 2028, and the company is sufficiently capitalized to achieve PBGENE-HBV and PBGENE-DMD data milestones through 2028.
In April, Precision received a $7.5 million clinical milestone payment from TG Therapeutics under the azer-cel license, inclusive of $5.25 million cash and $2.25 million for TG’s purchase of Precision common stock. On August 1, Alex Kelly was promoted from chief financial officer to chief operating officer, and Naresh Tanna was promoted to chief financial officer. The company was added to the Russell 2000 Index effective June 26, 2026.