Recent Updates — BNTC

Benitec Biopharma announced positive interim clinical data from its ongoing Phase 1b/2a study of BB-301, a gene therapy candidate for Oculopharyngeal Muscular Dystrophy (OPMD). The results showed robust and durable improvements in swallowing function across both low-dose and high-dose cohorts. All nine patients treated to date were formal responders to the therapy, with no serious adverse events reported. High-dose patients demonstrated greater relative improvements in throat emptying ability and functional swallowing capacity at three months post-treatment compared to low-dose patients. The company plans to advance toward a pivotal study expected in mid-2027.

Benitec Biopharma is a clinical-stage biotechnology company developing disease-modifying genetic medicines using its proprietary ddRNAi platform.

Benitec Biopharma received formal feedback from the U.S. Food and Drug Administration following a Type C meeting regarding its BB-301 pivotal trial. The FDA requested additional available data, including results from the Benitec-sponsored OPMD Natural History Study, to support discussions on an open-label, single-arm study design. Final confirmation of the pivotal study design is expected in the first quarter of 2027, with patient enrollment planned to begin in mid-2027. The company will present interim clinical results from its ongoing Phase 1b/2a study at the European Society of Gene and Cell Therapy Annual Congress in October 2026. Benitec Biopharma is a clinical-stage biotechnology company developing disease-modifying genetic medicines based on its proprietary ddRNAi platform.

Benitec Biopharma Inc. dismissed Baker Tilly US, LLP as its independent registered public accounting firm and appointed Ernst & Young LLP (EY) to serve in that capacity for the fiscal year ending June 30, 2027. The change was made following a routine governance review by the Audit Committee, with no disagreements on accounting principles or reportable events cited between the company and Baker Tilly. A prior material weakness regarding share-based compensation controls reported in the 2025 annual report was remediated as of June 30, 2026. Benitec Biopharma Inc. operates in the biotechnology industry, focusing on developing nucleic acid therapeutics for genetic diseases.

Benitec Biopharma Inc. reported full-year financial results for the fiscal year ended June 30, 2026, alongside an operational update on its lead candidate BB-301. The company incurred a net loss of $45.5 million, or $0.98 per share, compared to a $37.9 million loss in the prior year, driven by increased research and development expenses of $23.4 million and general and administrative costs of $27.8 million. As of June 30, 2026, Benitec held approximately $180 million in cash. Clinically, all six Cohort 1 patients completed the 12-month follow-up period for BB-301, while Cohort 2 is fully enrolled with three safely treated patients. The company held a Type C meeting with the FDA to discuss pivotal study design and anticipates initiating the pivotal trial in mid-2027. Benitec Biopharma Inc. operates as a clinical-stage biotechnology company developing disease-modifying genetic medicines using its proprietary ddRNAi platform.