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BiondVax Pharmaceuticals Ltd. (BVXV) is a clinical-stage biopharmaceutical company pioneering universal influenza vaccines and novel immunotherapies. This dedicated news hub provides investors and industry observers with timely updates on corporate developments, research breakthroughs, and regulatory milestones.
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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced topline results from its pivotal Phase 3 trial of the M-001 universal flu vaccine. The trial involved 12,463 adults aged 50 and older, but results showed no significant difference between the vaccine and placebo in reducing flu illness severity, failing both primary and secondary efficacy endpoints. However, the trial met the primary safety endpoint. The company expressed disappointment and plans to examine options to leverage their assets moving forward. Previously, M-001 demonstrated immune response in earlier studies.
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced on October 2, 2020, that it has initiated a $100 million At-The-Market (ATM) equity offering program with BofA Securities as the lead agent, along with Citigroup and Credit Suisse. The company is not obligated to sell any American Depositary Shares (ADSs) under this program. Proceeds will be used for general corporate purposes, which may include R&D, regulatory matters, and potential acquisitions. The ongoing Phase 3 clinical trial for its M-001 universal influenza vaccine has enrolled over 12,400 participants across 83 sites globally.
BiondVax Pharmaceuticals Ltd. (BVXV) reported its Q2 2020 financial results, revealing a net loss of NIS 42 million (~$12.1 million), a decrease from NIS 47.4 million in Q2 2019. Total operating expenses fell to NIS 16 million (~$4.61 million) from NIS 19.7 million year-over-year, driven by reduced costs from a nearly completed pivotal Phase 3 trial and completion of its manufacturing facility. R&D expenses also decreased to NIS 11.9 million (~$3.4 million) from NIS 15.2 million. As of June 30, 2020, cash and cash equivalents stood at NIS 38.7 million (~$11.2 million), down from NIS 72.4 million at year-end 2019.
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) announced its Annual General Meeting on September 2, 2020, in Tel Aviv, Israel. Shareholders can view the Proxy Statement on the SEC website. The company is also set to release results from its pivotal Phase 3 clinical trial for the M-001 universal flu vaccine candidate between late September and October 2020, though delays are possible. BiondVax's vaccine aims for multi-strain protection against influenza and has completed seven trials showing it is safe and immunogenic.
BiondVax Pharmaceuticals (Nasdaq: BVXV) announced that the pivotal Phase 3 trial for its M-001 universal influenza vaccine has concluded participant site visits, enrolling over 12,400 volunteers aged 50+. This trial aims to evaluate M-001's effectiveness and safety against influenza strains. Unlike traditional vaccines, M-001 requires no annual updates, potentially offering year-round protection. Results are anticipated by the end of 2020, which could significantly impact vaccine effectiveness amid ongoing public health concerns.
BiondVax Pharmaceuticals Ltd. (BVXV) reported its financial results for Q1 2020, showing total operating expenses of NIS 20.0 million (approximately $5.6 million), a significant increase from NIS 7.1 million in Q1 2019. The company's R&D expenses rose to NIS 19 million ($5.3 million) from NIS 5.7 million year-over-year. The net loss for the quarter was NIS 3.7 million (about $1.0 million), a decline from net income of NIS 566 thousand in Q1 2019. Cash and cash equivalents fell to NIS 42.5 million ($11.9 million) from NIS 72.4 million at the end of 2019, primarily due to costs associated with its Phase 3 trial.
