Financial Performance - The net loss for the three months ended December 31, 2024, was approximately $7.1 million, a decrease from the net loss of $8.4 million for the same period in 2023, reflecting a $1.3 million improvement [133]. - The net loss for the six months ended December 31, 2024, was approximately $11.3 million, significantly reduced from $19.1 million for the same period in 2023, a decrease of $7.8 million [139]. - Other income decreased by approximately $395,000, from $545,000 in 2023 to $150,000 in 2024, mainly due to a change in fair value of derivative liabilities and reduced interest income [146]. - The accumulated deficit as of December 31, 2024, was approximately $345.9 million [148]. Operating Expenses - Total operating expenses for the three months ended December 31, 2024, were approximately $7.3 million, down from $8.8 million in 2023, indicating a net decrease of approximately $1.5 million [134]. - Total operating expenses for the six months ended December 31, 2024, were approximately $11.4 million, down from $19.7 million in 2023, reflecting a decrease of approximately $8.3 million [140]. - Selling, general and administrative expenses increased by approximately $409,000, from $4.2 million in 2023 to $4.6 million in 2024, driven by higher consultancy and legal fees [145]. Research and Development - Research and development expenses decreased to approximately $4.7 million for the three months ended December 31, 2024, from $6.5 million in 2023, a decline of $1.8 million [135]. - Research and development expenses decreased by approximately $8.7 million, from $15.3 million in 2023 to $6.7 million in 2024, primarily due to the completion of clinical studies [141]. - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease was completed in December 2022, meeting both primary and secondary objectives [124]. - The Company received a clinical trial award of up to $13.1 million from the U.S. Department of Defense for evaluating bezisterim (NE3107) for long COVID treatment [126]. - BIV201, an investigational drug for liver disease, has received FDA Fast Track and Orphan Drug status, with ongoing discussions regarding Phase 3 clinical testing [127]. - In March 2023, data from the first 15 patients treated with BIV201 indicated at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the pre-treatment period [129]. - Bezisterim (NE3107) has been patented in the United States, Australia, Canada, Europe, and South Korea, indicating the Company's commitment to protecting its intellectual property [122]. Cash Flow and Financing - As of December 31, 2024, the company had working capital of approximately $23.2 million and cash and cash equivalents totaling approximately $24.4 million [148]. - The company used net cash in operations totaling approximately $12.2 million, while net cash provided by financing activities was approximately $12.7 million [149]. - 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 [150]. - The company raised approximately $15.9 million from October offerings, with gross proceeds before fees and expenses [154]. - The company completed a public offering in September 2024, raising approximately $3.0 million before deducting fees and expenses [153]. - The company has raised funds through various equity offerings, including a Controlled Equity Offering that generated approximately $6,400 in net proceeds [152].
BioVie(BIVI) - 2025 Q2 - Quarterly Report