{"id":910433,"date":"2025-11-14T17:42:19","date_gmt":"2025-11-14T22:42:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/benitec-biopharma-releases-first-quarter-2026-financial-results-and-provides-operational-update\/"},"modified":"2025-11-14T17:42:19","modified_gmt":"2025-11-14T22:42:19","slug":"benitec-biopharma-releases-first-quarter-2026-financial-results-and-provides-operational-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/benitec-biopharma-releases-first-quarter-2026-financial-results-and-provides-operational-update\/","title":{"rendered":"Benitec Biopharma Releases First Quarter 2026 Financial Results and Provides Operational Update"},"content":{"rendered":"
\n

\n \u2013<\/em>
\n Fast Track Designation was granted for BB-301 following U.S. Food and Drug Administration (FDA) review of positive interim clinical study results and proprietary Responder Analysis planned for use in pivotal study for BB-301\u2013<\/em>\n <\/p>\n

\n \u2013Positive interim clinical study results<\/em>
\n from the Phase 1b\/2a trial of BB-301, showed a <\/em>
\n 100% responder rate<\/em>
\n
\n , <\/em>
\n <\/strong>
\n with all six patients in Cohort 1 meeting the formal statistical criteria for response to BB-301\u2013<\/em>\n <\/p>\n

\n \u2013First patient of Cohort 2 successfully treated with BB-301 in Q4 of 2025\u2013<\/em>\n <\/p>\n

\n \u2013The Company raised approximately $100 million in an oversubscribed public offering of common stock, which is expected to fund advancement of the BB-301 Oculopharyngeal Muscular Dystrophy (OMPD) registrational program and associated regulatory filing activities\u2013<\/em>\n <\/p>\n

HAYWARD, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) — Benitec Biopharma Inc. (NASDAQ: BNTC) (\u201cBenitec\u201d or the \u201cCompany\u201d), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary \u201cSilence and Replace\u201d DNA-directed RNA interference (\u201cddRNAi\u201d) platform, today announced financial results for its first fiscal quarter ended September 30, 2025. The Company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2025 with the U.S. Securities and Exchange Commission (SEC).<\/p>\n

\u201cWe are fortunate to have achieved several important milestones this year. We previously announced positive interim clinical study results from the Phase 1b\/2a trial of BB-301, with a 100% responder rate to BB-301 in Cohort 1. BB-301 was also granted Fast Track Designation by the FDA, and we completed a significant capital raise to fund the advancement of BB-301, which has the potential to become the first approved therapy for the treatment of the central clinical symptom plaguing OPMD patients,\u201d said Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec. \u201cWe remain extremely grateful for the strong support from the OPMD community and their families, the clinical research community, and the investment community. We look forward to continued collaboration with the FDA in 2026 to advance the development of BB-301.\u201d<\/p>\n

\n
\n Operational Updates<\/u>
\n <\/strong>\n <\/p>\n

The key milestones related to the development of BB-301 for the treatment of Oculopharyngeal Muscular Dystrophy (OPMD)-related dysphagia, are outlined below:<\/p>\n