Financial Performance - The net loss for the three months ended September 30, 2024, was approximately $4.2 million, a decrease of $6.5 million compared to a net loss of $10.7 million for the same period in 2023[123]. - Total operating expenses for the three months ended September 30, 2024, were approximately $4.1 million, down from $10.9 million in the same period in 2023, reflecting a decrease of approximately $6.8 million[124]. - Research and development expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline of approximately $6.9 million from $8.9 million for the same period in 2023[125]. - As of September 30, 2024, the Company had working capital of approximately $13.3 million and cash and cash equivalents totaling approximately $20.0 million[131]. - 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[133]. Clinical Trials and Drug Development - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease was completed in December 2022, with both primary and secondary objectives met[114]. - 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, with trials expected to commence by early 2025[116]. - BIV201, an investigational drug for liver disease, showed a 53% reduction in ascites fluid for patients who completed treatment, sustained at a 43% reduction over three months post-treatment[119]. - The FDA has granted Fast Track and Orphan Drug status to BIV201, which is being evaluated for the treatment of ascites due to chronic liver cirrhosis[117]. - The Company anticipates finalizing protocol designs for the Phase 3 study of BIV201 following guidance from the FDA regarding clinical testing[120]. Capital Raising Activities - During the three months ended September 30, 2024, the Company sold approximately 2,143 shares of Common Stock for total net proceeds of approximately $6,400 after commissions and offering costs[135]. - The Company closed a public offering on September 25, 2024, of 1,360,800 shares at a combined public offering price of $1.53 per share, generating gross proceeds of approximately $3.0 million before expenses[136]. - In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares, with gross proceeds of approximately $15.9 million before expenses[137]. - The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following issuance[137]. - The Company issued placement agent warrants in the October Offerings to purchase 412,800 shares of Common Stock at prices ranging from $1.88 to $3.54 per share[137]. - The September Common Warrants have an exercise price of $1.53 per share and are immediately exercisable upon issuance[136]. - The Company incurred offering expenses of approximately $747,000 for the September 2024 Offering and approximately $2.8 million for the October Offerings[136][137]. - The September Placement Agent's Warrants are exercisable at a price of $1.91 per share, equal to 125% of the public offering price[136]. Accounting Policies - The Company added a Grant Program accounting policy for the three-month period ended September 30, 2024, with no other significant changes to critical accounting policies[138]. - The Company determined that recent accounting pronouncements are either not applicable or expected to have minimal impact on financial statements[139].
BioVie(BIVI) - 2025 Q1 - Quarterly Report