BioVie Inc. Reports Improved Financial Results, Net Loss Decrease, and Ongoing Clinical Trials for Innovative Drug Therapies

BioVie Inc. reported its financial results for the three months ended September 30, 2024, showing significant improvements in both net loss and operating expenses compared to the same period in 2023. The company recorded a net loss of approximately $4.2 million, a substantial decrease from the net loss of $10.7 million in the prior year, reflecting a reduction of $6.5 million. Total operating expenses also decreased to approximately $4.1 million from $10.9 million, primarily due to a decline in research and development (R&D) expenses, which fell to about $2.0 million from $8.9 million. This decrease was attributed to the completion of clinical trials in the previous fiscal year.

The company’s cash and cash equivalents as of September 30, 2024, were approximately $20.0 million, down from $23.8 million at the end of June 2024. Total current assets decreased to approximately $20.2 million from $24.0 million, while total assets also declined to approximately $21.2 million from $25.2 million. Current liabilities decreased significantly to approximately $6.8 million from $9.4 million, contributing to a stockholders' equity of approximately $14.1 million, down from $15.5 million.

BioVie continues to focus on developing innovative drug therapies for chronic conditions, including neurological disorders and liver disease. The investigational drug bezisterim (formerly NE3107) is being evaluated for its potential to treat Alzheimer's and Parkinson's diseases. The company announced topline efficacy data from a Phase 3 trial for bezisterim in November 2023, although the trial faced challenges due to protocol deviations at several study sites.

In addition to its ongoing clinical trials, BioVie received a clinical trial award of up to $13.1 million from the U.S. Department of Defense for its Long COVID Program, with plans to evaluate bezisterim for neurological symptoms associated with long COVID. The FDA has authorized the Investigational New Drug application for bezisterim, with trials expected to commence by early 2025.

The company executed a 1:10 reverse stock split effective August 6, 2024, and reported an accumulated deficit of approximately $338.7 million as of September 30, 2024. Despite these financial challenges, BioVie has not generated any revenue and does not anticipate doing so in the foreseeable future, relying on the success of its ongoing development and commercialization efforts.

In terms of financing, BioVie closed a public offering in September 2024, generating gross proceeds of approximately $3.0 million, and followed this with three registered direct offerings in October 2024, totaling approximately $15.9 million. The company continues to face uncertainties regarding its ability to secure sufficient financing to fund operations, raising concerns about its ability to continue as a going concern.