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Benitec Biopharma Discloses Q2 2022 Financial Results
HAYWARD, Calif., Feb. 14, 2022 /PRNewswire/ -- Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused,
About this update from Benitec Biopharma Inc.
[{"type":"text","content":"HAYWARD, Calif., Feb. 14, 2022 /PRNewswire/ -- Benitec Biopharma Inc. (NASDAQ: BNTC) (\"Benitec\" or \"the Company\"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference (\"ddRNAi\") platform, today announced the financial results for its Fiscal Year Q2 ended December 31, 2021. The Company has filed its quarterly report on Form 10-Q for the quarter ended December 31, 2021, with the U.S. Securities and Exchange Commission. \n\n \n \n \n \n \n \n\n \nOperational Updates\nThe key milestones related to the investigational agents under development by the Company and other corporate updates are outlined below:\nRegulatory Interactions: \nBenitec successfully completed the regulatory interactions required to support initiation of the BB-301 clinical development program in 2022 Successful regulatory engagement comprised the completion of the following meetings: Pre-Clinical Trial Application (Pre-CTA) Consultation Meeting with Health Canada Scientific Advice Meeting with The National Agency for the Safety of Medicines and Health Products in France (L'Agence nationale de sécurité du médicament et des produits de santé or \"ANSM\") Type C Meeting with the U.S. Food and Drug Administration (\"FDA\")BB-301 Clinical Development Program:\nThe BB-301 clinical development program will begin in mid-2022, and the conduct of the development program will comprise approximately 76-weeks of follow-up for each Oculopharyngeal Muscular Dystrophy (OPMD) study participant, inclusive of : 6-month pre-treatment observation periods for evaluation of the baseline disposition and natural history of OPMD-derived dysphagia in each study participant 1 day of BB-301 dosing to initiate participation in the Phase 1b/2a single-arm, open-label, sequential, dose escalation cohort study 52-weeks of post-dosing follow-up for conclusive evaluation of the primary and secondary endpoints of the Phase 1b/2a BB-301 treatment studyThe OPMD Natural History Study will begin in mid-2022 and this observational study will facilitate the characterization of OPMD patient disposition at baseline and assess subsequent rates of progression of dysphagia (swallowing impairment) in subjects with OPMD via the use of: Quantitative radiographic measures of global swallowing function and ph...