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Benitec Biopharma Provides Operational Update and Releases its 2021 Fiscal Year-End Financial Results
HAYWARD, Calif., Sept. 20, 2021 /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., Sept. 20, 2021 /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 provided an operational update and announced the financial results for its fiscal year ended June 30, 2021. The Company has filed its annual report on Form 10-K for the year ended June 30, 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: \nBB-301 (Oculopharyngeal Muscular Dystrophy Program) \nOn September 8, 2021, Benitec announced three key updates related to the progress of the BB-301 development program, including: updated results for the BB-301 Pilot Dosing Study in large animals, updates on European and North American regulatory interactions for the BB-301 development program, and a comprehensive overview of the design of, and key primary and secondary endpoints for, the Phase 1b/2a clinical trial which is planned for initiation in 2022. All of the updates were positive and demonstrated the significant progress that has been achieved for the BB-301 development program; below is a summary of each update: BB-301 Large Animal Pilot Dosing Study: On September 8th the Company disclosed updated analyses that continue to demonstrate robust, dose-dependent target tissue transduction for BB-301, dose-dependent gene expression for the three distinct components of the therapeutic transgene, and biologically significant knock-down of the target PABPN1 protein. These updated data provide continued support for the planned advancement of BB-301 into the Phase 1b/2a clinical study in 2022. European Regulatory Interaction: Following the disclosure in February 2021 of the positive interim data from the BB-301 Pilot Dosing Study in large animals, Benitec completed a 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\") in the first half of 2021. At the conclusion of the meeting: The BB-301 Pilot Dosing Study was viewed...