Benitec Biopharm Stock Price, News & Analysis

Benitec Biopharma (NASDAQ: BNTC) announced a proposed underwritten public offering of common stock (or pre-funded warrants) and a concurrent registered direct offering with long-term investor Suvretta Capital. The company will grant underwriters a 30-day 15% overallotment option. The offerings are expected to close on November 7, 2025, subject to customary closing and market conditions. The SEC declared effective a Form S-3 registration on September 29, 2025. Leerink Partners, TD Cowen and Evercore ISI are bookrunning managers. A prospectus supplement will be filed with the SEC and offering materials will be available from the bookrunners and the SEC website.

Benitec Biopharma (NASDAQ: BNTC) reported positive interim results from the BB-301 Phase 1b/2a trial and said the FDA granted Fast Track designation for BB-301 for treatment of OPMD with dysphagia. All six patients in Cohort 1 met the formal statistical criteria for response (a 100% response rate).

Cohort 1 showed sustained improvements in dysphagic symptom burden, post-swallow residue, timed drinking capacity, and pharyngeal closure. BB-301 has prior Orphan Drug designations from both FDA and EMA. First patient in Cohort 2 was treated in Q4 2025. Benitec plans an FDA meeting in 2026 to confirm pivotal study design.

Benitec Biopharma (NASDAQ: BNTC) appointed Dr. Sharon Mates to its board of directors, effective November 2, 2025. Dr. Mates previously co-founded and served as CEO and chairman of Intra‑Cellular Therapies from 2002 until its ~$14.6 billion acquisition by Johnson & Johnson in 2025. She led development efforts that included FDA approval of CAPLYTA in 2019. Benitec said her experience will support progression of its BB‑301 OPMD program and broader development of its ddRNAi platform.

Benitec Biopharma (NASDAQ: BNTC) will provide a clinical update on BB-301, its gene therapy candidate for Oculopharyngeal Muscular Dystrophy (OPMD).

The company said it will report results for the six patients treated in Cohort 1 of the Phase 1b/2a study and host an investor webcast on November 3, 2025 at 8:00 am EST.

Webcast registration was posted by the company for investor access to the update.

Benitec Biopharma (NASDAQ: BNTC) released its full year 2025 financial results and provided updates on its BB-301 clinical program for OPMD treatment. The company reported a net loss of $37.9 million ($1.05 per share) compared to $22.4 million in 2024. Total expenses increased to $41.8 million, with R&D expenses at $18.3 million and G&A expenses at $23.4 million.

Key operational highlights include a favorable DSMB recommendation to continue enrollment into Cohort 2 of the BB-301 Phase 1b/2a Treatment Study, expected to begin in Q4 2025. The company maintains a strong financial position with $97.7 million in cash and cash equivalents as of June 30, 2025. Interim clinical results for Cohort 1 are anticipated in Q4 2025.

Benitec Biopharma (NASDAQ: BNTC) has announced significant progress in its Phase 1b/2a Clinical Treatment Study for BB-301, its gene therapy treatment. The company successfully completed treatment of the sixth and final subject in Cohort 1 with a low dose of BB-301 in April 2025.

The Independent Data Safety Monitoring Board (DSMB) has completed its review of all six subjects in Cohort 1 and recommended continuation of subject enrollment. Following this positive recommendation, enrollment for Cohort 2 is expected to begin in Q4 2025. The company reports encouraging results regarding BB-301's safety profile, particularly noting the benefits of their local direct intramuscular delivery method.

Benitec Biopharma (NASDAQ: BNTC) reported its Q3 2025 financial results. The company's net loss widened to $9.4 million ($0.24 per share) compared to $4.3 million ($0.23 per share) in Q3 2024. Total expenses increased to $10.2 million from $4.1 million year-over-year, with R&D expenses rising to $6.0 million and G&A expenses reaching $4.2 million. The company maintains a strong cash position of $103.6 million. On the clinical front, Benitec completed treatment of the sixth and final Subject in Cohort 1 with the low dose of BB-301, their gene therapy treatment for OPMD (Oculopharyngeal Muscular Dystrophy). The company plans to enroll additional subjects at a higher dose later this year, with clinical updates for Cohort 1 expected in Q4 2025.

Benitec Biopharma (Nasdaq: BNTC) has announced the pricing of a combined stock offering expected to raise $30 million in gross proceeds. The offering consists of:

- An underwritten offering of 1,443,000 common stock shares (or pre-funded warrants)

- A concurrent registered direct offering of 900,000 shares with Suvretta Capital

Each share is priced at $13.00, while pre-funded warrants are priced at $12.9999 with a $0.0001 exercise price. The offerings are expected to close on March 26, 2025. The company plans to use the proceeds for product candidate development, working capital, and general corporate purposes. Leerink Partners and TD Cowen are serving as bookrunning managers, with Citizens Capital Markets as lead manager.

Benitec Biopharma (NASDAQ: BNTC) has reported positive interim clinical results from its Phase 1b/2a study of BB-301 gene therapy for Oculopharyngeal Muscular Dystrophy (OPMD). Three subjects treated with BB-301 showed significant improvements in swallowing function:

- Subject 1 achieved durable improvements 12 months post-treatment with 37% reduction for thin liquid, 18% for solid food, and 29% for thick liquids in swallowing efficiency
- Subject 2 reached a clinically normal swallowing profile at 12 months with 91% symptom reduction
- Subject 3 achieved a clinically normal swallowing profile at 3 months with 68% symptom reduction

The study has treated five subjects safely with the low-dose BB-301, with the sixth and final subject of Cohort 1 expected to receive treatment in Q2 2025. No severe adverse events have been reported. Results will be presented at the 2025 Muscular Dystrophy Association Conference in Dallas.