BNTC

The BB-301 pivotal trial remains on track to begin in mid-2027 Discussions regarding an open-label, single-arm, pivotal study for BB-301 are ongoing, and based on these discussions, the FDA requested additional available data, including data from the Benitec-sponsored OPMD Natural History Study Final pivotal study design expected to be confirmed in 1Q 2027 Benitec will present interim clinical results from the ongoing BB-301 Phase 1b/2a study as a late-breaking poster presentation, which will encompass 12-month follow-up data for all six Cohort 1 patients and interim follow-up data for all three Cohort 2 patients, at the European Society of Gene and Cell Therapy (ESGCT) Annual Congress in Hamburg, Germany, October 27-30, 2026 HAYWARD, Calif., Oct. 05, 2026 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage biotechnology company developing disease-modifying genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (ddRNAi) platform, today announced the receipt of formal feedback from the U.S. Food and Drug Administration (FDA) following the Type C meeting in 3Q 2026.

Benitec Biopharma (BNTC) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

All six Cohort 1 (low dose BB-301) patients have completed the full 12-month post-treatment follow-up period, and Cohort 2 (high dose BB-301) is fully enrolled with all three patients having been safely treated A Type C meeting was held with the U.S. Food and Drug Administration in 3Q2026 to discuss the BB-301 pivotal study design, and meeting minutes are anticipated in October Additional interim clinical study results from the ongoing BB-301 Phase 1b/2a trial have been accepted for late-breaking presentation at the Annual Congress of the European Society of Gene and Cell Therapy (ESGCT) in Hamburg, Germany taking place on October 27-30, 2026 Well-capitalized with cash, as of June 30, 2026, of approximately $180 million. HAYWARD, Calif.

Late-breaking abstract for BB-301 presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in March demonstrated durable responses to low dose BB-301 at 12-months and 24-months post-treatment and further improvements in depth of response following treatment with high dose BB-301 at the 3-month post-treatment follow-up time-point, with both doses demonstrating disease modifying outcomes BB-301 Phase 1b/2a interim clinical study results selected for oral presentation at the 2026 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting on May 15 Advancement of Cohort 2 enrollment continues as Patient 1 and Patient 2 were both safely treated with high dose BB-301 in the ongoing Phase 1b/2a clinical study of BB-301; Benitec remains on track to provide updated interim clinical study results in 2H-2026 The Company remains on track to engage with U.S. Food and Drug Administration (FDA) mid-year to formalize the BB-301 pivotal study design Benitec is well-capitalized to advance BB-301 through completion of the BB-301 pivotal study with cash as of March 31, 2026, of approximately $184.8 million. HAYWARD, Calif.

- Interim clinical results for the BB-301 Phase 1b/2a study include 12-month post-treatment follow-up results for the first four Cohort 1 completers, 24-month post-treatment follow-up results for the first Cohort 1 Patient, and interim clinical results for the first Cohort 2 Patient - BB-301 is the only clinical-stage therapeutic agent in development for the treatment of dysphagia in patients diagnosed with OPMD HAYWARD, Calif., April 28, 2026 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference ("ddRNAi") platform, today announced the acceptance of the interim clinical results from the ongoing BB-301 Phase 1b/2a first-in-human study for Oculopharyngeal Muscular Dystrophy (OPMD) with moderate dysphagia for oral presentation at the 2026 American Society of Gene and Cell Therapy Annual Meeting (ASGCT).