BIVI 10-K & 10-Q changes, risk factors and insider trading

Our business, financial condition, operating results and prospects are subject to the following risks. Additional risks and uncertainties not presently foreseeable to us may also impair our business operations. If any of the following risks or the risks described elsewhere in this report actually occurs,occur, 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.

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,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. 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 us 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 Companyus 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 Companywe may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval process. For example, our drug product candidate bezisterim (NE3107) was cleared by FDA for use in a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in subjects who have mild to moderate AD. Enrollment in that trial began in August 2021, with a planned primary completion in late 2022/early 2023. On November 29, 2023, the Companywe 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 Companywe began the process of analyzing the trial data, data, the Companywe found significant deviations from the protocol and cGCP violations at 15 study sites (virtually all of which were from one geographic geographic area). This highly unusual level of suspected improprieties led the Companyus to exclude all patients from these sites. We subsequently notified notified FDA’s OSI of such significant deviations from study protocol, the suspected improprieties, and the study sites involved. The identification of significant deviations from study protocol and numerous GCP violations at multiple study sites raised questions regarding the validity and robustness of data from these study sites. The unplanned exclusion of so many patients left the trial underpowered for its primary endpoints. However, based on the remaining dataset from those other sites determined to be in compliance with the protocol and GCP’s, a preliminary signal of efficacy was detected. 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 JulyJune 31,30, 2025,2026, the Companywe had cash deposited in in a certain financial institution in excess of federally insured levels. The CompanyWe regularly monitorsmonitor the financial stability of these financial financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. Bank failures, events involving limited liquidity, defaults, non-performance, or other adverse developments that affect financial institutions, or concerns or rumors about such events, may lead to liquidity constraints. In 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. markets. While previous bank failures have not had a material direct impact on the Company’sour operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, theour 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.

We are, and may in the future become, subject to various legal proceedings and claims that arise in or outside the ordinary course of business. For example, Onon January 19, 2024, a purported shareholdersecurities class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Companyus and certain of itsour officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al., No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035,24-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 the Company’sour business, operations, compliance, and prospects, including information related related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable Alzheimer’s Disease,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 the Company’sour 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, theThe defendants filed a motion to dismiss the amended complaint,complaint on August 21, 2024, and that motion was fully briefed in December 2024. Onon March 27, 2025, the court denied thethat motionmotion. to dismiss, and theThe parties are now engaged in fact discovery. On February 13, 2026, the plaintiffs earlyfiled stagesa ofmotion for class certification and a motion for leave to file a second amended complaint. Defendants opposed the discoverymotion for process.leave In addition,to onamend. DecemberOn 30,June 20245, 2026, the court granted the plaintiffs’ motion for leave to amend, and Aprilthe 28,same 2025, respectively, two shareholder derivative lawsuits were filed inday the Unitedplaintiffs filed Statestheir District CourtSecond forAmended theComplaint. DistrictOn ofJune Nevada15, by putative stockholders, allegedly on behalf of the Company, that piggy-back on the securities class action, alleging, among other things, that2026, the defendants breachedfiled theira fiduciaryNotice dutiesof byNon-Opposition causingand orReservation failingof Rights in response to prevent the securities violationsmotion allegedfor inclass certification, and on June 18, 2026, the securitiesCourt granted the plaintiffs’ motion and certified the class action.subject to the defendants’ reservation of rights. The defendants answered the Second Amended Complaint on June 22, 2026. The Company believes that all of thesethe claims are without merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.

Although we have insurance coverage that we believe applies to these actions, the coverage is subject to a $2 million deductible. 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.applies. Furthermore, our insurance coverage may be insufficient, and our assets may be insufficient to cover any amounts that exceed our insurance coverage, and we may have to pay damage awards or otherwise may enter into a settlement arrangement in connection with such claims. A decision adverse to our interests in the pending lawsuits, or in similar or related litigation, could result in the payment of substantial damages, or possibly fines, and could have a material adverse effect on our business, our stock price, cash flow, results of operations and financial condition. We have not established any reserve for any potential liability relating to the pending lawsuits or any potential future lawsuits. Any such payments or settlement arrangements in current or future litigation could have a material adverse effect on our business, operating results or financial condition. In addition, such lawsuits may make it more difficult to finance our operations and affect our ability to make payments for damages.

We have no products approved for commercial sale and, to date, we have not generated any revenue. Our ability to generate revenue depends heavily on (a) successful completion of one or more development programs demonstrating in human clinical trials that BIV201 and bezisterim (NE3107), our product candidates, are safe and effective; (b) our ability to seek and obtain regulatory approvals, including, without limitation, with respect to the indications we are seeking; (c) successful commercialization of our product candidates; and (d) market acceptance of our products. There are no assurances that we will achieve any of the forgoingforegoing objectives. Furthermore, our product candidates are in the development stage, and have not been fully evaluated in human clinical trials. If we do not successfully develop and commercialize our product candidates we will not achieve revenues or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations.

Although ourthe 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.

Investors are subject to all the risks incident to the creation and development of a new business and each investor should be prepared to withstand a complete loss of his, her or its investment. Furthermore, the accompanying financial statements have been prepared assuming that we will continue as a going concern. We have not emerged from the development stage, and may be unable to raise further equity. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements included elsewhere in this Form 10-Kreport 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 ourthe 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 ana 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. Other manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications (“ANDAs”) in the United States. In support of an ANDA, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent as the RLD. Generic products may be significantly less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Moreover, generic versions of RLDs are often automatically substituted for the RLD by pharmacies when dispensing a prescription written for the RLD. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

The FDA may not approve an ANDA for a generic product until any applicable period of non-patent exclusivity for the reference listed drug has expired. 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”). An NCE is an active ingredient that has not previously been approved by FDA in any other NDA. Specifically, in cases where such exclusivity has been granted, an ANDA may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug. If an ANDA is submitted to FDA with a Paragraph IV Certification, the generic applicant must also provide a “Paragraph IV Notification” to the holder of the NDA for the RLD and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of the basis for the ANDA applicant’s position that the relevant patent(s) is invalid or would not be infringed. If the patent owner brings a patent infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4 years and 5 years after the NDA approval. Any such stay will be terminated earlier if the court rules that the patent is invalid or would not be infringed.

We have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S. for the treatment of hepatorenal syndromeHRS on November 21, 2018 and treatment of ascites due to all etiologies except cancer on September 8, 2016. Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S. In the European Union (“EU”), Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent a life-threatening or chronically debilitating debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria. The company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of marketing exclusivity during which time FDA may not approve another application for the same drug for the same orphan disease or condition. Orphan Drug Exclusivity does not prevent FDA approval of another application for the same drug for a different disease or condition, or of an application for a different drug for the same rare disease or condition. Orphan Drug exclusive marketing rights may be lost under several circumstances, including a later determination by the FDA that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a ten-year period of market exclusivity.

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,HRS, 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. Further, even though BioVie has obtained Orphan Drug Designations Designations for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential product candidates, such designation may not effectively protect BioVie from competition because different drugs can be approved for the same condition and the same drug can be approved for different conditions and potentially used off-label in the Orphan indication. Even after an Orphan Drug is approved, the FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

In addition, other companies have received Orphan Drug designations for terlipressin. Mallinckrodt Hospital Products IP Limited received Orphan Drug designation in 2004 for terlipressin for the treatment of Hepatorenal Syndrome.Syndrome (HRS). Mallinckrodt has already gained FDA approval for its product, lyophilized terlipressin acetate acetate for bolus intravenous administration for the treatment of hepatorenal syndromeHRS Type 1 in September 2022. PharmaIN Corporation received Orphan Drug Designation in 2012 for PGC-C12E-terlipressin for treatment of ascites due to all etiologies except cancer. In addition, Ferring Pharmaceuticals Pharmaceuticals Inc. received Orphan Drug designation in 1986 for terlipressin for the treatment of bleeding esophageal varices. If one of those or any other company with Orphan Drug Designation for the same drug as ours for the same proposed disease or condition receives FDA approval and Orphan Drug Exclusivity before our product is approved, approval of our drug(s) for the orphan indication may be blocked for seven years by the other company’s Orphan Exclusivity and they may obtain a competitive advantage even after the exclusivity period expires associated with being the first to market.

Developing biopharmaceutical products, including conducting pre-clinical studies and clinical trials and establishing manufacturing capabilities, requires substantial funding. Additional financing will be required to fund the research and developmentR&D of our product candidates. We have not generated any product revenues, and do not expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from the FDA and other regulatory authorities for our product candidates.

We may not have the resources to complete the development and commercialization of any of our proposed product candidates. We will require additional financing to further the clinical development of our product candidates. In the event that we cannot obtain the required financing, we will be unable to complete the development necessary to file an NDA with the FDA for BIV201 or bezisterim (NE3107). This will delay or require termination of researchR&D 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 developmentR&D 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.

Development and extensive testing will be required to determine the technical feasibility and commercial viability of BIV201 and bezisterim (NE3107). Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available, at a minimum, for several years, if ever. Our drug product candidate, BIV201 (continuous infusion terlipressin), was cleared by the FDA to undergo testing in a mid-stage (Phase 2b) clinical trial for the treatment of refractory ascites due to cirrhosis. On June 24, 2021, we announced that the first patient has been enrolled in this study. In March 2023, the open-label trial was stopped after 15 of the planned 30 patients were enrolled, and an evaluation of those completed patients assessed. Encouraging data from these patients appeared to show that treatment with BIV201 plus SOC resulted in a reduction in ascites fluid accumulation during treatment versus pre-treatment. In June 2023 and December 2025,2024, the Companywe requested and subsequently received received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of chronic liver liver cirrhosis. TheWe Company isare currently finalizing the protocol design for the Phase 3 study of BIV201 with a focus on demonstrating clinical benefit through a composite primary endpoint of complications and disease progression in patients with cirrhosis and ascites who have recently recovered from AKI.

Because we have limited human capital and financial resources, we focus on research programs and drug candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial drugs or profitable market opportunities. Our spending on current and future research and developmentR&D programs and drug candidates for specific indications may not yield any commercially viable drugs. If we do not accurately evaluate the commercial potential or target market for a particular drug candidate, we may relinquish valuable valuable rights to that drug candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate.

At any time and for any reason, we may determine that one or more of our discovery programs or preclinical or clinical drug candidates or programs does not have sufficient potential to warrant the allocation of resources toward such program or drug candidate. Accordingly, we may choose not to develop a potential drug candidate or elect to suspend, deprioritize or terminate one or more of our discovery programs or preclinical or clinical drug candidates or programs. For example, BIV201 has received Orphan Drug designation for Ascites and HRS. On June 23, 2021, we announced that FDA has had provided guidance on our planned Phase 3 clinical trial of BIV201 in (HRS-AKI)Ascites and have since reached agreement on the key elements of the trial design. Thereafter, we deprioritized HRS-AKIthe program due to focusfunding. onMallinckrodt bezisterimgained (NE3107).FDA approval for its product, lyophilized terlipressin acetate for bolus intravenous administration for the treatment of hepatorenal syndrome Type 1 in September 2022. When we suspend, deprioritize or terminate a program or drug candidate in which we have invested significant resources, we will have expended resources on a program that will not provide a full return on our investment and may have missed the opportunity to have allocated those resources to potentially more productive uses, including existing or future programs or drug candidates.

We have never manufactured products in the highly regulated environment of pharmaceutical manufacturing, and our team has limited experience in the manufacture of drug therapies. There are numerous regulations and requirements that must be maintained to obtain licensure and permitting required prior to the commencement of manufacturing, as well as additional requirements to continue manufacturing pharmaceutical products. We currently do not own or lease facilities that could be used to manufacture any products that might be developed by us, and have contracted with an experienced Contract Manufacturing Organization (“CMO”) to perform the manufacturing of our newinvestigational product candidates BIV201 and bezisterim (NE3107). In addition, we do not have the resources at this time to acquire or lease suitable facilities. If we or our CMO fail to comply with regulations, to obtain the necessary licenses and knowhow or to obtain the requisite financing in order to comply with all applicable regulations and to own or lease the required facilities in order to manufacture our products, we could be forced to cease operations, which would cause you to lose all of your investment.

BIV201 and bezisterim (NE3107) and any other product candidates that we develop may have to compete with other products and product candidates for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing to do so. If we need to find another source of drug substance or drug product manufacturing for BIV201 and bezisterim (NE3107), we may not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonablyreasonable terms, or at all. If we are unable to do so, we will need to develop our own commercial-scale manufacturing capabilities, which would: impact commercialization of BIV201 and bezisterim (NE3107) in the U.S. and other countries where it may be approved; require a capital investment by us that could be quite costly; and increase our operating expenses.

The process of obtaining FDA approval is costly and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States include, among other things: (a) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information on the product’s safety; (b) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics; (c) the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the product for its recommended use; and (d) filing by a company and acceptance and approval by the FDA of a NDA for a drug product or a Biologics License Application (a “BLA ”) for a biological product to allow commercial distribution of the drug or biologic. A delay in one or more of the procedural steps outlined above could be harmful to us in terms of getting our product candidates through clinical testing and to market, which could have a materially adverse effect on our business.

We currently depend upon the efforts and abilities of our executive and senior management team of Cuong Do, our Chief Executive Officer–PresidentOfficer-President; Wendy Kim, our Chief Financial Officer; Dr. Dr Joseph Palumbo, our Executive Vice President– - Chief Medical Officer; Penelope Markham, our Senior Vice AscitesPresident - Liver Disease and Long COVID Programs & Strategic Initiatives–; Chris Reading, our Senior Vice President– - Alzheimer’s Disease Program; Clarence Ahlem, our Senior Vice President –- Operations President–Operations, Discovery and Parkinson’s Disease Program; ; and David Morse, our Senior Vice President– - Chief Regulatory Officer; who all serve the Company full-time. The loss or unavailability of the services of any of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition and results of operations which may cause you to lose all of your investment. We have not obtained, do not own, nor are we the beneficiary of key-person life insurance.

The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors.factors, These factors includeincluding the availability of patent and other protection for technology and products, the ability to commercialize technological technological developments and the ability to obtain government approval for testing, manufacturing and marketing.

Although there are not currently any therapies approved by the FDA specifically for the treatment of ascites due to liver cirrhosis, we still face significant competitive and market risk. Other companies, such as Ocelot Bio, are developing therapies for severe complications of advanced liver cirrhosis, which may in the future be developed for the treatment of ascites, and these therapies could compete indirectly or directly with our product candidate. Similarly, other companies, such as Biogen and Eli Lilly, are developing treatments for AD and PD, which could compete indirectly or directly with our product candidate. There may be other competitive development programs of which we are unaware. Even if our product candidates are ultimately approved by the FDA, there is no guarantee that once itthey isare on the market doctors will adopt them in favor of current ascites ascites treatment procedures such as diuretics and paracentesis with respect to BIV201 and AD and PD with respect to bezisterim (NE3107). These These competitive and market risks could have a material adverse effect on our business, prospects, financial condition and results of operations operations which may cause you to lose all of your investment.

The successful development of biopharmaceuticals is highly uncertain. A variety of factorsfactors, including,including pre-clinical study results or regulatory approvals, could cause us to abandon the development of our product candidates.

Our Articles of Incorporation and Bylaws require us to indemnify our officers and directors against claims associated with carrying out the duties of their offices. We are also required to advance the costs of certain legal defenses upon the indemnitee undertaking to repay such expenses to the extent it is determined that such person was not entitled to indemnification of such expenses. Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, may be permitted to our officers, directors, or control persons, the Commission has advised that such indemnification is against public policy and is therefore unenforceable.

We have fiveseven (57) granted and sevensix (76) pending patent applications for our liquid formulations of terlipressenterlipressin that claim priority to International Patent Application Number PCT/US2020/034269 filed on May 22, 2020 and published as WO2020/237170. Also, we own two (2) U.S. patents and one (1) European patent directed to various methods of treating ascites with BIV201, and we are pursuing additional patent coverage in other jurisdictions. We also have thirteentwelve (1312) issued U.S. patents, fiveseven (57) pending U.S. applications, three three(3) pending Patent Cooperation Treaty applications(“PCT”) applications, four (4) issued foreign patents and eightnine (89) pending foreign patent applications directed to protecting bezisterim (NE3107) and related compounds and methods of making and using thereof. However, there can be no assurance that our pending patent applications will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, bezisterim (NE3107), or any other product candidates or to provide us with competitive advantages.

We can provide no assurance that any issued patents will provide us with any competitive advantage. We cannot be certain that there is no invalidating prior art of which we and the patent examiner are unaware of or that our interpretation of the relevance of prior art is correct. If a third-party patent or patent application is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing in a form that provides any competitive advantage for our drug candidates. Failure to obtain additional issued patents could have a material adverse effect on our ability to develop and commercialize our drug candidates. Even if our patent applications do issue as patents, third parties may be able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party’s patents and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one or more licenses from such third parties, if available on commercially reasonable terms, or be prohibited from commercializing our drug candidates.

We seek to protect our proprietary positions by, among other things, filing patent applications in the United States and abroad related to our current drug candidates and other drug candidates that we may identify. Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time-consuming and complex, and we may not be able to file and prosecute all necessary or desirable patent applications, or maintain, enforce and license any patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and developmentR&D output before it is too late to obtain patent protection. Moreover, under certain of our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and maintenance of patent applications, or to maintain the rights to patents licensed to or from third parties.

If we were to initiate legal proceedings against a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant could counterclaim that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or insufficient written description. Grounds for a presentability assertion could be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO or made a misleading statement during prosecution. Third parties may also raise similar claims before the USPTO or an equivalent foreign body, even outside the context of litigation. Potential proceedings include reexamination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our technology or any drug candidates that we may develop. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware of during prosecution. These assertions may also be based on information known to us or the USPTO. If a defendant were to prevail prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards towards the applicable drug candidates or technology related to the patent rendered invalid or unenforceable. Such a loss of patent rights would would materially harm our business, financial condition, results of operations and prospects.

Some of our competitors are larger than we are and have substantially greater resources. They are, therefore, likely to be able to sustain the costs of complex patent litigation or proceedings more effectively than we can because of their greater financial resources and more mature and developed intellectual property portfolios. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing, misappropriating or otherwise violating our intellectual property. Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims could result in substantial costs and diversion of management resources, which could harm our business. In addition, the uncertainties associated with litigation could compromise our ability to raise the funds necessary to continue our clinical trials, continue our internal research programs, or in-license needed technology or other drug candidates. There could also be public announcements of the results of the hearing, motions, or other interim proceedings or developments. If securities analysts or investors perceive those results to be negative, it could cause the price of shares of our Common Stock to decline. Any of the foregoing events could harm our business, financial condition, results of operationoperations and prospects.

In the past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer. If any of our stockholders were to bring such a lawsuit against us,us (in addition to the already-filed, consolidated Securities Class Action described above), we could incur substantial costs defending the lawsuit and the attention of our management would be diverted from the operation of our business.

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 in any other offering 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 “Acuitas Warrants”), 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 June 30, 2025,2026 there were warrants outstanding to purchase an aggregate of 960,0988,282,037 shares (including 380,000 pre-funded warrants) of our Common Stock at exercise prices ranging from $13.70 $2.50 to $1,250.00$582.00 per share, 84,8722,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $19.00$1.31 to $4,209.00 $774.00 per share and restricted stock units totaling 7,212.300. 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,Acuitas Group Holdings, LLC (“Acuitas”), as amended on May 9, 2021. The achievement of these milestones could result in the issuance of up to 180,000 shares of our Common Stock, further diluting the interest of holders of our Common Stock.

As of June 30, 2025,2026, our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 1,917,0617,545,474 shares of our Common Stock issued and 1,914,2247,542,638 shares of our Common Stock issued and outstanding. Accordingly, we may issue up to an additional 798,082,939792,454,526 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.

The market price and trading volume of our Common Stock has been volatile. We expect that the market price of our Common Stock will continue to fluctuate significantly for many reasons, including in response to the risk factors described in this prospectusreport or for reasons unrelated to our specific performance. In recent years, years, the stock market has experienced extreme price and volume fluctuations. This volatility has affected the market prices of securities issued issued by many companies for reasons unrelated to their operating performance and may adversely affect the market price and trading volume of of our Common Stock. Prices for our Common Stock may also be influenced by the depth and liquidity of the market for our Common Stock, investor investor perceptions about us and our business, our future financial results, the absence of cash dividends on our Common Stock and general economic economic and market conditions. In the past, securities class action litigation has often been instituted against companies following periods of volatility in their stock price. This type of litigation could result in substantial costs and could divert our management and other resources.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with U.S. generally accepted accounting principles (“GAAP”).principles. Under standards established by the Public Company Accounting Oversight Board (“PCAOB”), a deficiency in internal control over financial reporting exists when the design or operation of a control does not allow management or personnel, in the normal course of performing their assigned functions, to prevent or detect misstatements on a timely basis. The PCAOB defines a material weakness as a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented, or detected and corrected, on a timely basis.

Our officers have limited public company experience, which could impair our ability to comply with legal and regulatory requirements such as those imposed by Sarbanes-Oxley Act of 2002. Such responsibilities include complying with federal securities laws and making required disclosures on a timely basis. Any such deficiencies, weaknesses or lack of compliance could have a materially adverse effect on our ability to comply with the reporting requirements of the Exchange Act, which is necessary to maintain our public company status. If we were to fail to fulfill those obligations, our ability to continue as a U.S. public company would be in jeopardy in which event you could lose your entire investment in ourthe Company.

The existence of the forgoingforegoing provisions and anti-takeover anti-takeover measures could limit the price that investors might be willing to pay in the future for shares of our Common Stock. They could also deter potential acquirers of our company, thereby reducing the likelihood that you could receive a premium for your Common Stock in an acquisition.

BioVieWe Inc. (the “Company” or “we” or “our”) isare a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.

Neurodegenerative Disease ProgramPrograms

The Company acquired the biopharmaceutical assets assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021. The acquired assets included NE3107 (or “bezisterim”). bezisterim. Bezisterim, the approved generic name for NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’sAD disease (“AD”) and Parkinson’s disease (“PD”),PD, and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”),FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 6 million Americans suffering from AD, 1 million Americans suffering from PDPD, and Long COVID affects approximately 20 million adults in the US,US andsuffering from Long COVID, with millions more affected worldwide.

InWith neurodegenerativerespect disease,to the mechanism of action, we believe bezisterim (NE3107) inhibits activation of inflammatory ERK and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with TNF signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. By binding to ERK and selectively modulating NFκB activation and BezisterimTNF-α (NE3107)production doeswithout not interfereinterfering with their homeostatic functions (e.g., insulin signaling and neuron growth and survival)., we Both inflammationbelieve andthat insulinbezisterim resistancemay areoffer driversclinical ofimprovements in several disease indications, including PD, AD and PD.long COVID.

The previous Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), that we completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

In April 2024, the Company was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense (“DOD”),DOW, awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, the FD&A and the U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approvingplan the associated Investigation New Drug Application (“IND”), to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our IND application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID. The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue. The trial commenced in May 2025.2025 and completed enrollment in May 2026. The Company currently expects to report topline results in late summer 2026.

C. Alzheimer’s Disease (NCT05083260)

On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim in the treatment of mild to moderate AD. The study had co-primary endpoints lookingmeasuring at cognitioncognitive impairment using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of bezisterim orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice daily.

Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from protocol and currentcGCP good clinical practices (“cGCPs”) 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 and to refer the sites to the FDAOSI Office of Scientific Investigations (“OSI”) for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data.

The trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive lossdecline; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change. changes. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to be collected and analyzed.

The net loss for the year ended June 30, 2025,2026, was approximately $17.5$22.1 million as compared to the net loss of $32.1$17.5 million for the year ended June 30, 2024.2025. The net decreaseincrease of $14.6$4.6 million was primarily attributed to declineincrease in research and developmentoperating expenses of $13.8$4.6 million, andoffset by a net increase in other income, net of approximately $465,000. $55,000.

Total operating expenses for the years ended June 30, 20252026 and 20242025 were approximately $18.1$22.7 million and $32.2,$18.1 million, respectively. The net decreaseincrease of approximately $14.1$4.6 million was comprised of net increased R&D expenses of approximately $4.7 million was primarily dueattributed to the increased activities in both the Sunrise PD Phase 2 study and LC Phase 2 study offset by a decrease in researchgeneral and developmentadministrative expenses as a result of theapproximately completion of clinical trials in the prior fiscal year.$59,000.

Selling, General and Administrative Expenses

Other income, net was approximately $524,000$579,000 for the year ended June 30, 2025,2026 compared to approximatelyother $59,000income, net of $524,000, for the year ended June 30, 2024.2025. The net increase in other income of of approximately $465,000$55,000 was comprised of a decrease in the change in fair value of the related derivative liabilities of approximately $1.8 million, offset by the declinereduction in interest expense,expense netof $2.6approximately million$314,000 due to the payoff of the notes payable on December 1, 20242024, and offset by decline in interest income of approximately $284,000.$256,000.

Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements included elsewhere in this Form 10-Kreport do not include any adjustments that might result from the the outcome of this uncertainty.

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 in any other offering 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 “Acuitas Warrants”), 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 DecemberMarch 31, 2025,2026, there were warrants outstanding to purchase an aggregate of 8,282,037 shares (including 380,000 prefunded warrants) of our Common Stock at exercise prices ranging from $0.0001 $2.50 to $582.00 per share, 80,593 2,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $19.00$1.31 to $4,209.00 $774.00 per share and restricted stock units totaling 2,202.1,099. 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.

Neurodegenerative Disease ProgramPrograms

The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021. The acquired assets included NE3107 (or “bezisterim”). Bezisterim, the approved generic name for NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), and bezisterim could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD, 1 million Americans suffering from PDPD, and Long COVID (“LC”) affects approximately 20 million adults in the US,US andsuffering from Long COVID, with millions more affected worldwide.

InWith neurodegenerativerespect disease,to the mechanism of action, we believe bezisterim (NE3107) inhibits activation of inflammatory extracellular signal-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. By binding to ERK and selectively modulating NFκB Bezisterimactivation (NE3107)and doesTNF-α notproduction interferewithout interfering with their homeostatic functions (e.g., insulin signaling and neuron growth and survival)., Both inflammationwe andbelieve insulinthat resistancebezisterim aremay driversoffer ofclinical improvements in several disease indications, including PD, AD and PD.long COVID.

The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), that we completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

In April 2024, the Company was awarded a clinical trial grant of $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, the FDA and the U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan, including the FDA approving the associated Investigation New Drug Application (“IND”),plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim allowing the Company to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID. The Phase 2 ADDRESS-LC study is a randomized (1:1), placebo-controlled, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with long COVID who have cognitive impairment sequelae and fatigue. The trial commenced in May 2025.

C. Alzheimer’s Disease

Comparison of the three months ended DecemberMarch 31, 20252026 to the three months ended DecemberMarch 31, 20242025

The netNet loss for the three months ended December March 31, 20252026 was approximately $6.1 $5.3 million as compared to the net loss of approximately $7.1 million for the three months ended December 31, 2024. The net decrease of $1.0$2.8 million for the three months ended DecemberMarch 31, 20252025. The net increase of $2.5 million for the three months ended March 31, 2026 was comprised of a net decrease increase in research and development ("R&D") expenses of approximately $435,000,$1.9 million, and a net decreaseincrease in general and administrative expenses of approximately $595,000.$565,000.

Total operating expenses for the three months months ended DecemberMarch 31, 20252026 were approximately $6.3$5.4 million as compared to $7.3$3.0 million for the three months ended DecemberMarch 31, 2024. 2025. The net decrease increase of approximately $1.0$2.4 million for the three months ended DecemberMarch 31, 2025,2026 was comprised of a net decrease increase in R&D expenses of approximately $435,000$1.9 million and a net decreaseincrease in general and administrative expenses of approximately $595,000. $565,000.

Other income, net was approximately $193,000$115,000 compared compared to other income, net of approximately $180,000,$200,000, for the three months ended DecemberMarch 31, 20252026 and 2024,2025, respectively. The net increase decrease in other income of approximately $13,000$85,000 was primarily comprised of a reduction in interest expense of approximately $61,000 due to the payoff of the notes payable on December 1, 2024, offset by a reduction in interest income of approximately $54,000.$76,000.

Comparison of the sixnine months ended DecemberMarch 31, 20252026 to the sixnine months months ended DecemberMarch 31, 20242025

The netNet loss for the sixnine months ended December March 31, 2025 2026 was approximately $11.2$16.4 million comparable to the net loss of approximately $11.3$14.1 million for the sixnine months ended DecemberMarch 31, 2024. 2025. The net decreaseincrease of approximately $108,000$2.3 million for the sixnine months ended DecemberMarch 31, 20252026 was comprised of the net increase in operating expenses expenses of approximately $132,000$2.5 million offset by the increase in other income, net of approximately $240,000.$155,000.

Total operating expenses for the sixnine months ended ended DecemberMarch 31, 20252026 were approximately $11.5$16.9 million as compared to $11.4$14.4 million for the sixnine months ended DecemberMarch 31, 2024. 2025. The net R&Doperating expense increase of approximately $132,000$2.5 million for the sixnine months ended DecemberMarch 31, 2025,2026, was comprised of net increased research and developmentR&D expenses of approximately $511,000$2.4 primarilymillion attributed to the developmentincreased andactivities launch ofin both the Long COVID program in April 2025 and Sunrise PD Phase 2 studiesstudy inand MayLC 2025Phase offset2 bystudy theand declinean increase in general and administrative expenses of approximately $379,000.$189,000.

R&D expenses were approximately $7.2 $10.4 million for the sixnine months ended DecemberMarch 31, 2025,2026, an increase of approximately $511,000$2.4 million from $6.7$8.0 million for sixnine months ended December March 31, 2024. 2025. The net increase in R&D expenses of approximately $511,000 is comprised of increased direct study costs of approximately $818,000, $2.5 million, clinical team compensation of approximately $88,000,$282,000, travelabstracts, publications and conferences of approximately $153,000,$176,000, offset by approximately $541,000 of$619,000 in Chemistry, Manufacturing and Controls (“CMC”) and Discovery expenses that have been temporarily curtailed.

As the table indicates below, the increase in clinical studies of approximately $818,000$2.5 weremillion comprisedis ofattributed theto increased activity in both our clinical studies. Sunrise PD Phase 2 study costs costincreased ofby approximately $2.3$3.4 million as the study completed enrollment in January 2026 and the declinestudy inis currently nearing completion. Long Covid Phase 2 study costactivities ofdecreased and the net decrease in cost, net of reimbursements totalingtotaled approximately $1.5$786,000. millionThe net thatdecrease consistedin costs is caused by the timing of thereimbursements largeas amounts submitted for reimbursement are recorded on a cash basis or contractualwhen start-uprecoverability feeis paiddetermined to be probable. As of March 31, 2026, the CROtotal cost incurred since inception was approximately $9.4 million and theas lagof inMay receiving4, 2026 the reimbursementstotal duringcost thereimbursed sixwas months$9.4 ended December 31, 2024.million.

General and administrative expenses were approximately $4.2 $6.4 million and $4.6$6.2 million for the sixnine months ended DecemberMarch 31, 20252026 and 2024,2025, respectively. The net decreaseincrease of approximately $379,000 $189,000 was primarily attributed to decreasesincreases in stock-based compensation for the executive team and directors of approximately $238,000 and $151,000, respectively and consultancy feescompensation of approximately $565,000$78,000 and $214,000, respectively, primarily comprised of stock based compensation; offset by a net increase in legal fee expenses of approximately $546,000 that$423,000 primarily represented legal fees relatedattributed to the class action litigation.litigation; investor and public relations expenses of $71,000; and insurance premiums of approximately $55,000, offset by a decrease in consultancy fees of approximately $603,000 and a decline in other expenses such as meetings and travel totaling $24,000 and accounting and auditing fees of approximately $14,000.

Other income, net was approximately $390,000$505,000 compared to other income, net of $150,000,$350,000, for the sixnine months ended DecemberMarch 31, 20252026 and 2024,2025, respectively. The net increase in other income of of approximately $240,000$155,000 was comprised of a reduction in interest expense of approximately $315,000$314,000 due to the payoff of the notes payable on December 1, 2024, offset by a reductiondecline in interest income of approximately $79,000.$155,000.

As of DecemberMarch 31, 2025,2026, the Company had working capital of approximately $18.8 $15.2 million, cash and cash equivalents totaling approximately $20.5$13.1 million, stockholders’ equity of approximately $19.3$15.6 million, and an accumulated deficit of approximately $363.3$368.6 million.

The Company used net cash in operations totaling approximately $7.5$14.9 million and net cash provided by financing activities was comprised of net proceeds from capital raise activities of of approximately $10.5 million.