BioVie(BIVI) - 2026 Q2 - Quarterly Report

Financial Performance - The net loss for the three months ended December 31, 2025, was approximately $6.1 million, a decrease from the net loss of approximately $7.1 million for the same period in 2024, reflecting a reduction of $1.0 million [109]. - The net loss for the six months ended December 31, 2025, was approximately $11.2 million, comparable to the net loss of approximately $11.3 million for the same period in 2024 [115]. - For the six months ended December 31, 2025, the Company reported total revenue of approximately $4.9 million, an increase of $818,000 compared to $4.1 million for the same period in 2024 [119]. Operating Expenses - Total operating expenses for the three months ended December 31, 2025, were approximately $6.3 million, down from $7.3 million in 2024, indicating a decrease of approximately $1.0 million [110]. - Total operating expenses for the six months ended December 31, 2025, were approximately $11.5 million, slightly up from $11.4 million in 2024 [116]. - General and administrative expenses decreased to approximately $4.2 million for the six months ended December 31, 2025, down from $4.6 million in 2024, primarily due to reductions in stock-based compensation and consultancy fees [120]. - Legal fee expenses increased by approximately $546,000, primarily related to class action litigation [120]. Research and Development - Research and Development (R&D) expenses were approximately $4.3 million for the three months ended December 31, 2025, compared to $4.7 million in 2024, a decrease of approximately $435,000 attributed to reduced expenses in Long COVID studies [111]. - R&D expenses for the six months ended December 31, 2025, were approximately $7.2 million, an increase of approximately $511,000 from $6.7 million in 2024, driven by increased study costs [117]. - The increase in clinical study costs of approximately $818,000 was primarily due to the Sunrise PD Phase 2 study, which cost approximately $2.3 million [118]. - The Sunrise PD Phase 2 study incurred costs of approximately $2.6 million for the three months ended December 31, 2025, an increase of $1.5 million from $1.2 million in 2024 [112]. - Bezisterim (NE3107) is being tested for its potential to treat Alzheimer's disease, with significant data analysis ongoing from a Phase 3 clinical trial [105]. Funding and Financial Position - The Company received a clinical trial grant of $13.1 million from the U.S. Department of Defense for the Long COVID program, which commenced in May 2025 [101]. - The Company raised approximately $10.5 million in net proceeds from a public offering that closed on August 11, 2025, selling 5,620,000 units at $2.00 per unit [125]. - As of December 31, 2025, the Company had working capital of approximately $18.8 million and cash and cash equivalents totaling approximately $20.5 million [122]. - The Company has an accumulated deficit of approximately $363.3 million as of December 31, 2025 [122]. - The Company faces substantial doubt regarding its ability to continue as a going concern due to uncertainties in obtaining sufficient financing [124]. Accounting Policies - 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 [126]. Other Income - Other income increased to approximately $390,000 for the six months ended December 31, 2025, compared to $150,000 in 2024, driven by a reduction in interest expense of approximately $315,000 [121]. 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 commercialization efforts for future operations [123].