BIVI

If any of the following risks or the risks described elsewhere in this report actually occur, our business, financial condition or operating results could be materially adversely affected.
In such case, the trading price of our Class A Common Stock, par value $0.0001 (“Common Stock”) could decline, and our stockholders may lose all or part of their investment.
Risk Factor Summary Our business operations are subject to numerous risks, factors and uncertainties, including those outside of our control, which could cause our actual results to be harmed, including risks regarding the following: Risks Relating to Our Business and Industry · If our third party contractors 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. · Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control. · The concentration of our assets within a certain financial institution could have a material adverse effect on its business, financial condition and results of operations. · We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, which may have a material adverse effect on our business. · We have no products approved for commercial sale, have never generated any revenues, and may never achieve revenues or profitability, which could cause us to cease operations. · We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment. · If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected. · If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity and on our intellectual property rights. · We will need to raise substantial additional capital in the future to fund our operations, which could have a materially adverse effect on our business. · We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations. · Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control. · We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success. · We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business. · We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business. · Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations. · We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates. · The loss or unavailability of our management could put us at a competitive disadvantage. · We may not be able to attract and retain highly skilled personnel. · We may be unable to compete with enterprises in the highly competitive biotechnology and biopharmaceutical industries and those equipped with more substantial resources than us. · There may be conflicts of interest among our officers, directors and stockholders. · We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase our operating costs.
Risks Relating to Our Intellectual Property · We may be unable to obtain or protect intellectual property rights relating to our product candidates. · If we fail to comply with our obligations in the licensing and collaboration agreements, our competitive position, business, financial condition, results of operations and prospects could be harmed. · Compliance with federal regulations such as “march-in” rights may limit our exclusive rights and our ability to contract with non-U.S. manufacturers. · Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time. · We may not be able to protect our intellectual property rights throughout the world. · Changes in patent law could diminish the value of our patents and impair our ability to protect our drug candidate. · We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and our patents could be found invalid or unenforceable. · Our failure to identify relevant third-party patents or correctly interpret the relevance, scope or expiration of patents, we may be subject to infringement claims or may not be able to develop our drug candidates. · Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights. · We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property. · We may be subject to claims challenging the inventorship of our patents and other intellectual property. · Intellectual property rights do not necessarily address all potential threats. · Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline.
Risks Relating to Our Common Stock · Our stock price is and may continue to be volatile and you may not be able to resell our Common Stock at or above the price you paid. · 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. · The market price and trading volume of our Common Stock may be volatile. · Any failure to maintain effective internal control over financial reporting could harm us. · Limited trading market for our Common Stock could make it difficult to liquidate an investment. · The lack of public company experience of our management team could negatively affect our business. · Investors may be less attracted to our Common Stock because we are a smaller reporting company. · Additional audit and legal costs associated with periodic reporting requirements of the Exchange Act will negatively affect our ability to earn a profit. · Because we do not intend to pay any cash dividends on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them. · We are authorized to issue “blank check” preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities. · Provisions in our Articles of Incorporation, our Bylaws, and Nevada law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock.
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, independent institutional review boards (“IRBs”), manufacturers, suppliers, and other third parties to conduct our clinical trials, including those for our drug candidates bezisterim (NE3107) and BIV201.
If, due to the failure of either us 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, we may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval process.
On November 29, 2023, we announced topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) in the treatment of mild to moderate AD.
Upon trial completion, as we began the process of analyzing the trial data, we found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were from one geographic area).
This highly unusual level of suspected improprieties led us to exclude all patients from these sites.
As of June 30, 2026, we had cash deposited in a certain financial institution in excess of federally insured levels.
We regularly monitor the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.
While previous bank failures have not had a material direct impact on our operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, our ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
For example, on January 19, 2024, a purported securities class action complaint, captioned Eric Olmstead v.
District Court for the District of Nevada, naming us and certain of our officers as defendants.
Securities Litigation , No. 3:24-cv-00035 (the "Securities Class Action"), appointed the lead plaintiff, and approved selection of the lead counsel.
On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to our business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
The class action is on behalf of purchasers of our securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
The defendants filed a motion to dismiss the amended complaint on August 21, 2024, and on March 27, 2025, the court denied that motion.
The parties are now engaged in fact discovery.
On February 13, 2026, the plaintiffs filed a motion for class certification and a motion for leave to file a second amended complaint.
Defendants opposed the motion for leave to amend.
On June 5, 2026, the court granted the plaintiffs’ motion for leave to amend, and the same day the plaintiffs filed their Second Amended Complaint.
On June 15, 2026, the defendants filed a Notice of Non-Opposition and Reservation of Rights in response to the motion for class certification, and on June 18, 2026, the Court granted the plaintiffs’ motion and certified the class subject to the defendants’ reservation of rights.
The defendants answered the Second Amended Complaint on June 22, 2026.
The Company believes that the claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
Three shareholder derivative lawsuits piggy-backing on the Securities Class Action were filed in the United States District Court for the District of Nevada, allegedly on behalf of the Company, by three putative stockholders: Andrew Hulm on December 30, 2024; William Settel on April 28, 2025 and Cline Wilkerson on September 11, 2025, (collectively the “Related Derivative Lawsuits”).
Each Related Derivative Lawsuit names the same current and former officers and directors as defendants and alleges essentially the same claims: that the defendants breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the Securities Class Action, and related claims for unjust enrichment, waste of corporate assets, gross mismanagement, and abuse of control.
On September 29, 2025, at the request of the parties, the court consolidated all three Related Derivative Lawsuits under the caption In re BioVie Inc.
Derivative Litigation, Case No. 3:24-cv-0602-CSD (the “Consolidated Derivative Action”).
On January 27, 2026, at the request of the parties, the court stayed the Consolidated Derivative Action pending resolution of a summary judgment motion by defendants in the Securities Class Action.
That means that we are responsible for the first $2 million of loss arising from these actions, which includes both defense costs and damages, before any insurance coverage applies.
There are no assurances that we will achieve any of the foregoing objectives.
Although the Company was incorporated on April 10, 2013, we are a development stage biopharmaceutical company with potential therapies that have not been fully evaluated in clinical trials, and our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack of manufacturing experience and limited marketing experience, possible reliance on third parties for the development and commercialization of our proposed products, a competitive environment characterized by numerous, well-established and well capitalized competitors and reliance on key personnel.
The financial statements included elsewhere in this report do not include any adjustments that might result from the outcome of this uncertainty.
Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in the Company.
Our ability to become profitable depends primarily on our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our R&D efforts, including the timing and cost of clinical trials; and our ability to enter into favorable alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.
Once a New Drug Application (“NDA”) is approved, the product covered thereby becomes a “reference listed drug” (“RLD”), in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book.
The Federal Food, Drug and Cosmetic Act (“FDCA”) provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”).
We have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S. for the treatment of HRS on November 21, 2018 and treatment of ascites due to all etiologies except cancer on September 8, 2016.

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Gone since FY2025

If any of the following risks or the risks described elsewhere in this report actually occurs, our business, financial condition or operating results could be materially adversely affected.
In such case, the trading price of our Company’s Class A Common Stock, par value $0.0001 (“Common Stock”) could decline, and our stockholders may lose all or part of their investment. that involve risks and uncertainties.
These statements can be identified by the use of forward-looking terminology such as “believes,” “expects,” “intends,” “plans,” “may,” “will,” “should,” “predict” or “anticipation” or the negative thereof or other variations thereon or comparable terminology.
Actual results could differ materially from those discussed in the forward- looking statements as a result of certain factors, including those set forth below and Risk Factor Summary Our business operations are subject to numerous risks, factors and uncertainties, including those outside of our control, which could cause our actual results to be harmed, including risks regarding the following: Risks Relating to Our Business and Industry · If our third party contractors 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. · Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control. · The concentration of our assets within certain financial institutions could have a material adverse effect on its business, financial condition and results of operations. · We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, which may have a material adverse effect on our business. · We have no products approved for commercial sale, have never generated any revenues, and may never achieve revenues or profitability, which could cause us to cease operations. · We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment. · If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected. · If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity and on our intellectual property rights. · We will need to raise substantial additional capital in the future to fund our operations, which could have a materially adverse effect on our business. · We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations. · Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control. · We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success. · We have no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a materially adverse effect on our business. · We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business. · Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations. · We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates. · We may face business disruption and related risks if there is another pandemic. · The loss or unavailability of our management could put us at a competitive disadvantage. · We may not be able to attract and retain highly skilled personnel. · We may be unable to compete with enterprises in the highly competitive biotechnology and biopharmaceutical industries and those equipped with more substantial resources than us. · There may be conflicts of interest among our officers, directors and stockholders. · We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase our operating costs.
Risks Relating to Our Intellectual Property · We may be unable to obtain or protect intellectual property rights relating to our product candidates. · If we fail to comply with our obligations in the licensing and collaboration agreements, our competitive position, business, financial condition, results of operations and prospects could be harmed. · Compliance with federal regulations such as “march-in” rights may limit our exclusive rights and our ability to contract with non-U.S. manufacturers. · Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time. · We may not be able to protect our intellectual property rights throughout the world. · Changes in patent law could diminish the value of our patents and impair our ability to protect our drug candidate. · We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and our patents could be found invalid or unenforceable. · Our failure to identify relevant third-party patents or correctly interpret the relevance, scope or expiration of patents, we may be subject to infringement claims or may not be able to develop our drug candidates. · Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights. · We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property. · We may be subject to claims challenging the inventorship of our patents and other intellectual property. · Intellectual property rights do not necessarily address all potential threats. · Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our Common Stock to decline.
Risks Relating to Our Common Stock · Our stock price is and may continue to be volatile and you may not be able to resell our Common Stock at or above the price you paid. · 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. · The reverse stock split effected on July 7, 2025 has caused and could further cause our stock price to decline relative to its value before the reverse stock split and decrease the liquidity of shares of our common stock. · The market price and trading volume of our Common Stock may be volatile. · Any failure to maintain effective internal control over financial reporting could harm us. · Limited trading market for our Common Stock could make it difficult to liquidate an investment. · The lack of public company experience of our management team could negatively affect our business. · Investors may be less attracted to our Common Stock because we are as a smaller reporting company. · Additional audit and legal costs associated with periodic reporting requirements of the Exchange Act will negatively affect our ability to earn a profit. · Because we do not intend to pay any cash dividends on our Common Stock, our stockholders will not be able to receive a return on their shares unless they sell them. · We are authorized to issue “blank check” preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities. · Provisions in our Articles of Incorporation, our Bylaws, and Nevada law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock.
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.
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.
On November 29, 2023, the Company announced topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) in the treatment of mild to moderate AD.
Upon trial completion, as the Company began the process of analyzing the trial data, the Company found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were from one geographic area).
This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites.
The Company is considering: (1) employing the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical significance; and/or (2) designing a new Phase 3 study of bezisterim (NE3107) that leverages the most recent scientific literature relating to AD along with the company's understanding regarding the effects of bezisterim (NE3107) in persons with mild-moderate AD.
As of July 31, 2025, the Company had cash deposited in a certain financial institution in excess of federally insured levels.
The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents.
While previous bank failures have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
For example, On January 19, 2024, a purported shareholder class action complaint, captioned Eric Olmstead v.
District Court for the District of Nevada, naming the Company and certain of its officers as defendants.
Securities Litigation , No. 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel.
On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable Alzheimer’s Disease, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.
The class action is on behalf of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.
In August 2024, the defendants filed a motion to dismiss the amended complaint, and that motion was fully briefed in December 2024.
On March 27, 2025, the court denied the motion to dismiss, and the parties are now engaged in the early stages of the discovery process.
In addition, on December 30, 2024 and April 28, 2025, respectively, two shareholder derivative lawsuits were filed in the United States District Court for the District of Nevada by putative stockholders, allegedly on behalf of the Company, that piggy-back on the securities class action, alleging, among other things, that the defendants breached their fiduciary duties by causing or failing to prevent the securities violations alleged in the securities class action.
The Company believes that all of these claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.
That means that we are responsible for the first $2 million of loss arising from these actions, which includes both defense costs and damages, before any insurance coverage will apply.
There are no assurances that we will achieve any of the forgoing objectives.
Although our Company was incorporated on April 10, 2013, we are a development stage biopharmaceutical company with potential therapies that have not been fully evaluated in clinical trials, and our operations are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to the absence of an operating history, the lack of commercialized products, insufficient capital, expected substantial and continual losses for the foreseeable future, limited experience in dealing with regulatory issues, the lack of manufacturing experience and limited marketing experience, possible reliance on third parties for the development and commercialization of our proposed products, a competitive environment characterized by numerous, well-established and well capitalized competitors and reliance on key personnel.
The financial statements included elsewhere in this Form 10-K do not include any adjustments that might result from the outcome of this uncertainty.
Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our Company.
Our ability to become profitable depends primarily on our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research and development (“R&D”) efforts, including the timing and cost of clinical trials; and our ability to enter into favorable alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.
Once an NDA is approved, the product covered thereby becomes a “reference listed drug” (“RLD”), in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book.
The FDCA provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”).
We have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites due to all etiologies except cancer on September 8, 2016.
Even though BioVie has obtained two Orphan Drug Designations for its lead product candidate, terlipressin, for treatment of ascites and for treatment of hepatorenal syndrome, and may seek other Orphan Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there is no assurance that BioVie will be the first to obtain marketing approval for any particular rare indication.
Mallinckrodt Hospital Products IP Limited received Orphan Drug designation in 2004 for terlipressin for the treatment of Hepatorenal Syndrome.
Mallinckrodt has already gained FDA approval for its product, lyophilized terlipressin acetate for bolus intravenous administration for the treatment of hepatorenal syndrome Type 1 in September 2022.
Additional financing will be required to fund the research and development of our product candidates.
This will delay or require termination of research and development programs, preclinical studies and clinical trials, material characterization studies, regulatory processes, the establishment of our own laboratory or a search for third party marketing partners to market our products for us, which could have a materially adverse effect on our business.
The amount of capital we may need will depend on many factors, including the progress, timing and scope of our research and development programs, the progress, timing and scope of our preclinical studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to establish our own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market developments, changes made or new developments in our existing collaborative, licensing and other commercial relationships, and new collaborative, licensing and other commercial relationships that we may establish.
In June 2023 and December 2025, the Company requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of chronic liver cirrhosis.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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