Benitec Biopharma Releases First Quarter 2026 Financial Results and Provides Operational Update

Core Insights - Benitec Biopharma Inc. has received Fast Track Designation from the FDA for its gene therapy BB-301, which shows promise in treating Oculopharyngeal Muscular Dystrophy (OPMD) with a 100% responder rate in initial clinical trials [1][4][11] - The company successfully raised approximately $100 million through a public offering to support the advancement of BB-301 and related regulatory activities [1][5][6] - The first patient in Cohort 2 of the BB-301 trial was treated successfully, indicating progress in the clinical development of the therapy [1][4] Clinical Development - The Phase 1b/2a trial of BB-301 demonstrated a 100% responder rate in Cohort 1, with all six patients meeting the statistical criteria for response [1][4] - Significant improvements in swallowing function were observed in patients following treatment with BB-301 [4] - The FDA's Fast Track Designation aims to expedite the development and review process for BB-301, which targets dysphagia associated with OPMD [1][4][11] Financial Performance - For the first fiscal quarter ended September 30, 2025, total expenses were $9.8 million, up from $5.8 million in the same quarter of the previous year [6][7] - Research and development expenses were $3.4 million, slightly down from $3.6 million year-over-year, while general and administrative expenses increased significantly to $6.4 million from $2.2 million [6][7] - The net loss attributable to shareholders for the quarter was $9.0 million, or $(0.22) per share, compared to a net loss of $5.1 million, or $(0.18) per share, in the prior year [7][9] Corporate Updates - Benitec appointed Sharon Mates, Ph.D., to its Board of Directors, enhancing its leadership team [3] - The company hosted a webcast to discuss the positive interim clinical study results, indicating transparency and engagement with stakeholders [4] Capital Raise - The company completed an underwritten public offering of 5,930,000 shares at $13.50 per share, along with a direct offering of 1,481,481 shares to a long-term investor [5] - The net proceeds from this financing are intended to support the continued development of BB-301 and other corporate purposes [5]