PRECISION BIOSCIENCES INC SEC 10-Q Report

Precision BioSciences Inc., a biotechnology company specializing in gene editing technologies, has released its Form 10-Q report for the third quarter. The report provides a detailed overview of the company's financial performance and operational progress, highlighting significant challenges and strategic initiatives in its gene editing programs.

Financial Highlights

• Revenue: $0.06 million, reflecting a significant decrease from $68.06 million in the prior year period, primarily due to the conclusion of the Prevail Therapeutics Agreement and reduced revenue from the Novartis Agreement.
• Operating Loss: $(64.66) million, a substantial increase from $(1.32) million in the prior year period, driven by decreased revenue and ongoing research and development expenses.
• Net Income: $(65.86) million, compared to $24.91 million in the prior year period, reflecting the impact of reduced revenue and increased operating losses.
• Basic Net Income Per Share: $(6.14), compared to $3.87 in the prior year period, due to the significant net loss incurred during the period.
• Diluted Net Income Per Share: $(6.14), compared to $3.78 in the prior year period, consistent with the basic net income per share due to the anti-dilutive effect of share-based awards.

Business Highlights

• In Vivo Gene Editing Programs: Precision BioSciences is advancing its in vivo gene editing programs using its proprietary ARCUS platform, focusing on sophisticated edits such as gene insertions, excisions, and eliminations. The company is leveraging this platform to develop therapies for genetic and infectious diseases.
• PBGENE-HBV Program: The PBGENE-HBV program is under investigation in a global first-in-human clinical trial aimed at treating chronic Hepatitis B. The ELIMINATE-B trial is ongoing, with multiple dose levels being tested across various countries, including the U.S., Moldova, Hong Kong, New Zealand, and the U.K. The program has shown promising safety and efficacy data in early cohorts.
• PBGENE-DMD Program: This program targets Duchenne muscular dystrophy (DMD) and aims to restore a near-full length functional dystrophin protein. The program has received Rare Pediatric Disease and Orphan Drug Designations from the FDA. Clinical supplies are being manufactured, with an IND filing anticipated by the end of 2025.
• PBGENE-3243 Program: Development of this program, which targets mitochondrial disease, has been paused to prioritize PBGENE-HBV and PBGENE-DMD.
• iECURE Collaboration: In partnership with iECURE, Precision is pursuing a gene insertion approach for treating neonatal onset ornithine transcarbamylase deficiency. Clinical data presentations have been made at several international conferences, with ongoing studies in multiple countries.
• Imugene Partnership: Imugene Limited is developing azer-cel for oncology indications, with recent data showing high response rates in clinical trials. Precision received an $8.0 million milestone payment from Imugene, reflecting progress in this collaboration.
• Future Outlook: Precision plans to continue expanding its clinical trials and anticipates further data readouts in early 2026. The company is also preparing for potential Phase 2 and pivotal studies for its lead programs, pending supportive data.

SEC Filing: PRECISION BIOSCIENCES INC [ DTIL ] - 10-Q - Nov. 03, 2025