Financial Performance - The net loss for the three months ended March 31, 2025, was approximately $2.8 million, a decrease of $5.3 million compared to the net loss of $8.1 million for the same period in 2024[128]. - The net loss for the nine months ended March 31, 2025, was approximately $14.1 million, a decrease of $13.1 million compared to the net loss of $27.2 million for the same period in 2024[134]. - Total operating expenses for the three months ended March 31, 2025, were approximately $3.0 million, down from $7.7 million in the same period in 2024, reflecting a decrease of approximately $4.7 million[129]. - Total operating expenses for the nine months ended March 31, 2025, were approximately $14.4 million, down from $27.4 million in 2024, reflecting a decrease of approximately $13.0 million[135]. - Other income increased to approximately $350,000 for the nine months ended March 31, 2025, up from approximately $210,000 in the prior year, driven by a rise in interest income[139]. - The company used net cash in operations totaling approximately $13.4 million, while net cash provided by financing activities was approximately $12.7 million[141]. - 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[142]. - There is substantial doubt regarding the company's ability to continue as a going concern due to uncertainties in obtaining sufficient financing[143]. Research and Development - Research and development expenses decreased to approximately $1.3 million for the three months ended March 31, 2025, from $5.7 million in 2024, a reduction of $4.4 million[130]. - Research and development expenses for the nine months ended March 31, 2025, were approximately $8.0 million, a reduction of $13.0 million from $21.0 million in 2024, primarily due to the completion of clinical studies[136]. - Clinical studies expenses decreased by approximately $7.6 million, with current studies costing $4.1 million for the nine months ended March 31, 2025, compared to $69,079 for the same period in 2024[137]. Clinical Trials and Studies - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease completed in December 2022 met its primary and secondary objectives, demonstrating safety and potential enhancement of levodopa activity[121]. - The Company received a clinical trial award of up to $13.1 million from the U.S. Department of Defense to evaluate bezisterim (NE3107) for long COVID treatment, with trials expected to commence in May 2025[123]. - BIV201, an investigational drug for liver disease, is being evaluated for patients with ascites and has a target population generating over $5 billion in annual treatment costs[124]. - A Phase 2 study of BIV201 showed a 53% reduction in ascites fluid for patients who completed treatment, sustained at 43% over three months post-treatment[127]. Financial Position - As of March 31, 2025, the company had working capital of approximately $21.2 million and cash and cash equivalents totaling approximately $23.2 million[140]. Accounting Policies - A new Grant Program accounting policy was added for the nine-month period ended March 31, 2025, with no other significant changes to critical accounting policies[144]. - Recent accounting pronouncements were assessed and determined to have minimal impact on the company's financial statements[146]. Administrative Expenses - Selling, general and administrative expenses remained stable at approximately $6.2 million for the nine months ended March 31, 2025, with notable decreases in directors' and executive teams' compensation[138].
BioVie(BIVI) - 2025 Q3 - Quarterly Report