BIOVIE INC.

Other than as described below, there have been no material changes to the Risk Factors previously disclosed in our Annual Report on Form 10-K filed with the SEC on September 30, 2024 (the “2024 Form 10-K”), our quarterly report for the period ended September 30, 2024 (the “Q1 2025 10-Q”) and our quarterly report for the period ended December 31, 2024 (the “Q2 2025 10-Q”). The risks described in our 2024 Form 10-K, our Q1 2025 10-Q, our Q2 2025 10-Q and below are not the only risks facing our Company. Additional risks and uncertainties not currently known to the Company or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.

Risks Relating to Our Business and Industry

We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

We depend, and will continue to depend, on third parties, including, but not limited to, contract research organizations (“CROs”), clinical trial sites and clinical trial principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials, including those for our drug candidates bezisterim (NE3107) and BIV201. We rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities. Nevertheless, we retain ultimate responsibility for ensuring that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our reliance on third parties does not relieve the Company of our regulatory responsibilities. We and these third parties are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct of clinical trials on product candidates in clinical development. Regulatory authorities enforce cGCPs through periodic inspections and for-cause inspections of clinical trial principal investigators and trial sites. If, due to the failure of either the Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory requirements, or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval process.

Although we design the clinical trials for our product candidates, our CROs are tasked with facilitating and monitoring these trials. As a result, many aspects of our clinical development programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is outside our direct control, either partially or in whole. Our reliance on third parties to conduct clinical trials also results in less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if we were relying entirely upon our own employees. Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Our business may be impacted if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including but not limited to FDA’s IND regulations, cGCPs, fraud and abuse or false claims laws, healthcare privacy and data security laws, or provide the Company or government agencies with inaccurate, misleading, or incomplete data.

Risks Relating To Our Common Stock

You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

As of March 31, 2025, our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 18,545,735 shares of Common Stock issued and 18,517,376 issued and outstanding. Accordingly, we may issue up to an additional 781,454,265 shares of Common Stock. The future issuance of Common Stock may result in substantial dilution in the percentage of our Common Stock held by our then existing stockholders. We may value any Common Stock in the future on an arbitrary basis. The issuance of Common Stock for future services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our investors, might have an adverse effect on any trading market for our Common Stock and could impair our ability to raise capital in the future through the sale of equity securities.

In order to raise additional capital, we may in the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock. We may sell shares or other securities in offerings at a price per share that is less than the current market price of our securities, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The sale of additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock would dilute all of our stockholders, and if such sales of convertible securities into or exchangeable into our Common Stock occur at a deemed issuance price that is lower than the current exercise price of our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022, the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those warrants.

As of March 31, 2025, there were warrants outstanding to purchase an aggregate of 9,600,564 shares of our Common Stock at exercise prices ranging from $1.37 to $125.00 per share and 887,129 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.90 to $420.90 per share and restricted stock units totaling 109,039. We may also grant additional options, warrants or equity awards. To the extent such shares are issued, the interest of holders of our Common Stock will be diluted.

Moreover, we are obligated to issue shares of our Common Stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates (i.e., bezisterim (NE3107), NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix and Acuitas, as amended on May 9, 2021. The achievement of these milestones could result in the issuance of up to 1.8 million shares of our Common Stock, further diluting the interest of holders of our Common Stock.

If we fail to meet Nasdaq’s minimum bid price requirement prior to the one-year anniversary of our prior reverse stock split, we would be issued a delisting determination, and if our Common Stock were delisted from Nasdaq, it would adversely affect the liquidity of our Common Stock and the market price of our Common Stock could decrease.

Our Common Stock is currently listed on Nasdaq. Nasdaq has minimum requirements that a company maintain a minimum closing bid price of $1.00 per share. If a company fails to maintain Nasdaq’s minimum bid price requirement for a period of 30 consecutive business days, Nasdaq will deem the company noncompliant. In January 2025, the SEC approved amendments to Nasdaq’s minimum bid price compliance rules designed to limit reliance on reverse stock splits. The amendments provide that if a company fails to meet the bid price requirement and the company has effected a reverse stock split over the prior one-year period, the company would not be eligible for any compliance period to address the bid price deficiency. Instead, Nasdaq will move forward with delisting proceedings. We previously effected a reverse stock split on August 6, 2024. If we fail to meet the minimum bid price requirement prior to the one-year anniversary of our prior reverse stock split, or August 6, 2025, we would not be granted a compliance period and would be issued a delisting determination.

Since we have a recent history of our Common Stock trading below $1.00, we are currently considering available options to ensure continued compliance with Nasdaq’s minimum bid price requirement, including taking steps to effect a reverse stock split. There is no guarantee that any corrective measures we take would help us maintain compliance with the minimum bid price requirement or other Nasdaq listing rules. If our Common Stock were to be delisted, the liquidity of our Common Stock would be adversely affected and the market price of our Common Stock could decrease. Our failure to be listed on Nasdaq or another national securities exchange would have a material adverse effect on the value of your investment in us.