BioVie(BIVI) - 2026 Q1 - Quarterly Report

Financial Performance - The net loss for the three months ended September 30, 2025, was approximately $5.1 million, compared to a net loss of $4.2 million for the same period in 2024, reflecting an increase of $900,000 [100]. - Total operating expenses for the three months ended September 30, 2025, were approximately $5.3 million, up from $4.1 million in 2024, representing a net increase of approximately $1.2 million [101]. - The Company reported an accumulated deficit of approximately $357.3 million as of September 30, 2025 [107]. Research and Development - Research and development expenses increased to approximately $2.9 million for the three months ended September 30, 2025, from $2.0 million in 2024, an increase of approximately $946,000 [102]. - The Phase 2 study of bezisterim for Parkinson's Disease was completed in December 2022, with 45 patients randomized in a 1:1 ratio to receive either placebo or bezisterim [92]. - The Company is finalizing the protocol design for a Phase 3 study of BIV201, targeting a broader ascites patient population [96]. - The unplanned exclusion of patients in the Alzheimer's Disease trial left it underpowered for primary endpoints, with only 81 patients remaining in the Modified Intent to Treat population [98]. Funding and Capital - The Company received a clinical trial grant of $13.1 million from the U.S. Department of Defense in April 2024 for the Long COVID program [94]. - As of September 30, 2025, the Company had working capital of approximately $24.4 million and cash and cash equivalents totaling approximately $25.0 million [107]. - The Company closed an underwritten public offering of 5,620,000 units at $2.00 per unit, resulting in net proceeds of approximately $10.5 million [110]. - An additional 380,000 pre-funded units were sold at $1.999 per unit, with each pre-funded warrant immediately exercisable [110]. - The underwriter exercised its over-allotment option, purchasing an additional 667,300 warrants [110]. - Each warrant is exercisable at an exercise price of $2.50 per share and expires five years from the date of issuance [110]. Accounting and Compliance - There were no significant changes to the Company's critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2025 [111]. - Recent accounting pronouncements were determined to be either not applicable or expected to have minimal impact on the balance sheets or statement of operations [112]. - The Company did not identify any market risk disclosures applicable to smaller reporting companies [113]. Revenue Generation - The Company has not generated any revenue and does not expect to do so in the foreseeable future, relying on ongoing development and financing efforts [108].