News & Events zu BioVie Inc (BIVI)BIVIBioVie Inc

BioVie Enters Agreement to Sell 2.96 Million Shares to Institutional Investor

BioVie announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the purchase and sale of 2,962,500 shares of common stock at a purchase price of $1.60 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the company will issue and sell unregistered common warrants to purchase up to 2,962,500 shares of common stock. The common warrants will have an exercise price of $1.70 per share, will be exercisable six months following their issuance and will expire five and a half years from the issuance date. The gross proceeds from the Offering are expected to be approximately $4.74M, before deducting placement agent commissions and other Offering expenses. The company intends to use the net proceeds from the Offering for working capital and general corporate purposes. The closing of the Offering is expected to occur on or about November 5, subject to the satisfaction of customary closing conditions. A.G.P./Alliance Global Partners is acting as the sole placement agent for the Offering.

BioVie Presents Bezisterim Parkinson's Trial Results at ANA Annual Meeting

BioVie announced the presentation of results from the Phase 2 SUNRISE-PD clinical trial evaluating bezisterim in early Parkinson's patients at the 151st Annual Meeting of the American Neurological Association, or ANA, held October 17-20 in San Diego, California. Patients received bezisterim or placebo for 12 weeks. The study assessed motor symptoms, non-motor symptoms, activities of daily living, sleep, inflammatory biomarkers, and overall clinical benefit using a Composite Benefit Score, a fit-for purpose measure designed to capture changes across multiple domains of Parkinson's disease. Patients with higher systemic inflammation at the start of the trial - defined as above-median platelet counts above 230 10/L - demonstrated the strongest response to bezisterim. In this prespecified subgroup, which represents approximately half of the trial population, bezisterim-treated patients experienced significant improvements in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part I scores, Part III scores, and Total Scores. In the overall modified intent-to-treat population, efficacy outcomes generally favored bezisterim across multiple measures. The CBS also demonstrated a large treatment effect favoring bezisterim. Patients receiving bezisterim were 6.25-fold more likely to achieve clinically meaningful improvement on the CBS than patients receiving placebo, corresponding to a 525% relative increase and a 21-percentage-point absolute difference. Conversely, the risk of clinically meaningful worsening was approximately 70% lower with bezisterim than with placebo, representing a 32-percentage-point absolute risk reduction. Bezisterim was well tolerated, with a favorable safety profile compared with placebo. Treatment-emergent adverse events occurred in 39.3% of bezisterim-treated participants and 51.7% of placebo-treated participants. No severe or serious adverse events were reported in either group, and only one potentially treatment-related adverse event was reported in each treatment arm.

BioVie Presents Long COVID Study Results at AAN Annual Meeting

BioVie announced the presentation of results from the Phase 2 ADDRESS-LC study evaluating bezisterim in patients with Long COVID at the 151st Annual Meeting of the American Neurological Association. 203 patients received bezisterim or placebo for 12 weeks, and no single endpoint was designated as primary. Among the most fatigued half of patients at baseline, mean improvement in PROMIS Fatigue at Week 12 was 8.93 points with bezisterim compared with 5.30 points with placebo, p=0.02. The trial did not achieve statistical significance on any endpoint in the overall intent-to-treat population; statistically significant results were observed only in pre-specified subgroup analyses.