On September 20, 2021 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, reported the financial results for its fiscal year ended June 30, 2021 (Press release, Benitec Biopharma, SEP 20, 2021, View Source [SID1234588056]). 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.
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Operational Updates
The key milestones related to the investigational agents under development by the Company and other corporate updates are outlined below:
BB-301 (Oculopharyngeal Muscular Dystrophy Program)
On 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 as an appropriate dose range finding study.
The design of the ongoing GLP Biodistribution and Toxicology study was viewed as appropriate to support Phase 1b/2a testing of BB-301.
The manufacturing plan for clinical grade BB-301 drug product can be conducted under GMP conditions with a production process analogous to that that employed in prior large-scale production runs for BB-301.
The design of the Phase 1b/2a clinical trial can support the evaluation of BB-301 safety and clinical efficacy in key populations of OPMD patients.
North American Regulatory Interaction: Benitec has been granted a Type C Meeting with the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2021.
BB-301 Phase 1b/2a Clinical Study Design: On September 8th the Company provided a comprehensive overview of the key design elements of the upcoming BB-301 Phase 1b/2a clinical trial. The Phase 1b/2a study is planned for 2022. In addition to the determination of the safety and tolerability profiles of BB-301, the secondary endpoints of the trial will facilitate the accurate and reproducible characterization of the key physiological processes underlying the successful completion of the pharyngeal phase of swallowing. The core analytical tools and methods that will be employed during the clinical study will focus on functional measures of swallowing efficiency for OPMD patients during the pharyngeal phase of swallowing.
Corporate Updates
On April 30, 2021, the Company announced the closing of an underwritten public offering of common stock and common stock equivalents (the "April 2021 Capital Raise"). The Company received gross proceeds of approximately $14.3 million and net proceeds of approximately $12.7 million from the offering.
On October 6, 2020, the Company announced the closing of an underwritten public offering of common stock and common stock equivalents (the "October 2020 Capital Raise"). The Company received gross proceeds of approximately $11.5 million and net proceeds of approximately $9.9 million from the offering.
Jerel A. Banks, M.D., Ph.D., Executive Chairman and Chief Executive Officer of Benitec Biopharma commented, "Our team has made significant progress towards the goal of advancing BB-301 into clinical studies, and we remain focused on improving the lives of patients suffering from Oculopharyngeal Muscular Dystrophy. In the near future, we will begin to apply the ddRNAi platform to the treatment of other fatal genetic disorders with significant unmet medical need."
Financial Highlights
Total Revenues for the year ended June 30, 2021 were fifty-nine thousand dollars compared to $102,000 for the year ended June 30, 2020. Benitec recognized fifty-nine thousand dollars in customer revenues for the year ended June 30, 2021 compared to $97,000 for the comparable year ended June 30, 2020. The decrease in revenues from customers is due to the decrease in licensing and royalty revenues in the current year. During the year ended June 30, 2021, the Company recognized no revenue from government research and development grants, as compared $5 million for the comparable year ended June 30, 2020. The decrease in grant revenue is a result of Benitec no longer claiming the grant from the Australian government due to the Re-domiciliation of the Company to the United States of America.
Total expenses were $13.7 million for the year ended June 30, 2021 compared to $8.4 million for the comparable period in 2020. Royalty and license fees, research and development costs, and general and administrative costs comprise the primary corporate expenses. For the year ended June 30, 2021, Benitec incurred one hundred twenty-three thousand dollars in royalties and license fees compared to a gain of one hundred eighty-five thousand dollars for the comparable year ended June 30, 2020. The change is primarily due to a reversal of an accrual which created the negative balance for the year ended June 30, 2020. Benitec incurred $7 million of research and development expenses compared to $3 million for the comparable year ended June 30, 2020. The increase in research and development expenses are related to the pre-clinical studies associated with BB-301 as well as an increase in research and development costs related to stock-based compensation expenses. General and administrative expenses were $6.5 million and $5.5 million for the years ended June 30, 2021 and 2020, respectively. The increase for the year was due to the increase in insurance, consultants, legal and accounting fees.
The loss from operations for fiscal 2021 was $13.9 million compared to a loss of $8.3 million for fiscal 2020. Net loss attributable to shareholders for the fiscal year ended 2021 was $13.9 million, or $3.23 per basic and diluted share, compared to a net loss of $8.3 million, or $8.10 per basic and diluted share in earnings for the fiscal year ended 2020. At the end of fiscal year 2021 the Company had $19.8 million in cash and cash equivalents.