Benitec reports fiscal 2026 results, updates BB-301 trial progress and FDA meeting

Benitec Biopharma Inc. reported financial results for the fiscal year ended June 30, 2026, and gave an operational update on September 14, 2026. In its ongoing Phase 1b/2a trial of BB-301 for OPMD-related dysphagia, all six Cohort 1 low-dose patients have completed the full 12-month post-treatment follow-up period, and Cohort 2, the high dose group, is fully enrolled with all three patients having been safely treated.¹

On the regulatory front, a Type C meeting was held with the FDA in the third quarter of 2026 to discuss the BB-301 pivotal study design, with meeting minutes anticipated in October.¹ The company said it still expects to begin the pivotal trial in mid-2027, with CEO Jerel A. Banks stating the company looks forward to building on this momentum as we work toward the planned initiation of the pivotal study in mid-2027.¹

Additional interim data from the trial are set to be presented at a scientific meeting. 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 in Hamburg, Germany, taking place October 27-30, 2026.¹

On financials, Benitec said it is well-capitalized with cash of approximately $180 million as of June 30, 2026.¹ For the full fiscal year, total expenses were $51.2 million, up from $41.8 million a year earlier, and research and development expenses rose to $23.4 million from $18.3 million, primarily tied to ongoing clinical development of BB-301.¹ Net loss attributable to shareholders was $45.5 million, or $0.98 per basic and diluted share, compared with a net loss of $37.9 million, or $1.05 per share, in the prior year.¹