Benitec Biopharma Inc. develops clinical-stage genetic medicines based on its proprietary Silence and Replace DNA-directed RNA interference platform. The company’s lead program, BB-301, is a silence-and-replace therapeutic in development for dysphagia in patients with Oculopharyngeal Muscular Dystrophy, or OPMD.
Company news primarily covers BB-301 clinical development, including Phase 1b/2a study updates, follow-up data from treated cohorts, safety and clinical-activity observations, and presentations at gene therapy and muscular dystrophy medical meetings. Benitec also issues periodic financial results and operational updates tied to its development-stage biotechnology business.
Benitec Biopharma (BNTC) reported its Q1 fiscal results for the period ending September 30, 2021. The company reported total revenues of $0, down from $55,000 in Q1 2020, primarily due to reduced licensing and royalty revenues. Operating expenses surged to $4.8 million, compared to $2.7 million in the prior year, with research and development costs rising significantly to $2.8 million. The net loss reached $5 million, highlighting a negative EPS of $0.62. Positive updates were shared regarding the BB-301 program, including successful animal studies and planned Phase 1b/2a trials set for 2022.
Benitec Biopharma (NASDAQ: BNTC) provided an operational update and announced its fiscal year 2021 results, ending June 30. Total revenue was $59,000, a decrease from $102,000 in 2020, largely due to the cessation of government grants. Total expenses grew to $13.7 million from $8.4 million the previous year, with significant increases in R&D costs. The net loss was $13.9 million, or $3.23 per share, compared to a loss of $8.3 million, or $8.10 per share in 2020. The firm has $19.8 million in cash as it progresses its gene therapy programs, particularly BB-301 for Oculopharyngeal Muscular Dystrophy.
Benitec Biopharma (NASDAQ: BNTC), a biotechnology firm focused on gene therapy, announced that its Executive Chairman and CEO, Jerel A. Banks, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021, at 7:00 P.M. ET. The conference will be held virtually, and interested participants can register at www.hcwevents.com. Benitec specializes in developing genetic medicines using its patented ddRNAi platform, targeting conditions like Oculopharyngeal Muscular Dystrophy and Chronic Hepatitis B.
Benitec Biopharma (BNTC) detailed the design for the BB-301 Phase 1b/2a clinical trial aimed at treating Oculopharyngeal Muscular Dystrophy (OPMD), a genetic disorder affecting approximately 15,000 patients in the U.S., Canada, Europe, and Israel. The trial is slated for 2022 and intends to assess the safety and clinical activity of ascending doses of BB-301 via intramuscular injection. Key endpoints include measuring swallowing efficiency, muscle strength, and dysphagia severity. Currently, no approved therapies exist for OPMD, marking BB-301's potential as groundbreaking.
Benitec Biopharma (BNTC) has announced positive updates regarding its BB-301 Pilot Dosing Study in large animals, aiming for Oculopharyngeal Muscular Dystrophy (OPMD) treatment. Interim analyses revealed significant, dose-dependent tissue transduction and gene expression. BB-301 shows promise in knocking down the target protein responsible for OPMD, a condition affecting approximately 15,000 patients in North America and Europe. The findings support advancing BB-301 into Phase 1b/2a trials in 2022, following successful results from earlier studies in February 2021.
Benitec Biopharma has announced positive regulatory updates for its investigational gene therapy BB-301, intended for Oculopharyngeal Muscular Dystrophy (OPMD), affecting around 15,000 patients. The BB-301 Pilot Dosing Study yielded favorable interim results. European regulators deemed the study designs suitable for Phase 1b/2a trials, slated to begin in 2022. A Type C meeting with the FDA is scheduled for Q4 2021. The commercial opportunity for BB-301's treatment is predicted to exceed $1 billion. Currently, no approved treatments exist for OPMD.
Benitec Biopharma (NASDAQ: BNTC) announced an increase in its stock offering due to high demand, now totaling 3,036,366 shares at $4.25 each, with the potential for an additional 455,454 shares. The offering is expected to close around April 30, 2021, aiming to generate approximately $12.9 million in gross proceeds. The funds will be utilized for advancing product development, corporate purposes, and growth opportunities. The public offering is filed under an effective SEC registration statement.
Benitec Biopharma (NASDAQ: BNTC) announced an underwriting agreement with H.C. Wainwright & Co. for a firm commitment to purchase 1,764,705 shares at $4.25 each. The expected gross proceeds are approximately $7.5 million, set to close by April 30, 2021. The funds will support development activities and strategic growth opportunities. The public offering is registered under Form S-3 and will be available through SEC filings. This offering could enhance the company’s cash flow and support its gene therapy pipeline.
Benitec Biopharma announced successful interim analysis results from its BB-301 Pilot Dosing Study, showcasing significant dose-dependent transduction levels in pharyngeal muscles of Beagle dogs. The study achieved BB-301 copy numbers ranging from 1.7 to 8.6 copies per cell, with an average 74% inhibition of the mutant PABPN1 gene across doses. Compared to prior studies, Benitec's approach improved transduction by 248-fold. No approved treatments exist for Oculopharyngeal Muscular Dystrophy (OPMD), representing a $1 billion market opportunity. Future plans include a meeting in France and the initiation of human trials in 2022.
Benitec Biopharma, Inc. (NASDAQ: BNTC) has announced its virtual 2020 Annual Meeting of Stockholders scheduled for December 9, 2020, at 3 p.m. PT. Shareholders can access the meeting via a provided webcast link using the password BNTC2020 and their control number from the proxy card. The company is focused on developing ddRNAi-based therapeutics for chronic diseases like Oculopharyngeal Muscular Dystrophy and Chronic Hepatitis B. A recording of the meeting will be available afterward on their Investor Relations website.