BioVie Inc. is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. The company operates in the biotechnology and biopharmaceutical industries, which are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors, including the availability of patent and other protection for technology and products, the ability to commercialize technological developments, and the ability to obtain government approval for testing, manufacturing, and marketing. The company competes with biopharmaceutical firms in the United States, Europe, and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations.

Primary competitors named in the filing include Ocelot Bio, which is developing therapies for severe complications of advanced liver cirrhosis that could compete indirectly or directly with the company's product candidate BIV201, and Biogen and Eli Lilly, which are developing treatments for Alzheimer's disease and Parkinson's disease that could compete indirectly or directly with the company's product candidate bezisterim. The company's competitive advantages include its novel mechanism of action for bezisterim, which is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades, and its proprietary novel liquid formulation of terlipressin for BIV201, which is designed to improve convenience for outpatient administration and avoid potential formulation errors, with room temperature stability of the prefilled syringe in storage for up to two years, a key product differentiation versus terlipressin products in countries where the drug is approved.

The company generates revenue through the development and potential commercialization of drug therapies, though it has no products approved for commercial sale and has never generated any revenue. The company's primary customer segments are patients suffering from neurological and neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease, and long COVID, as well as patients with advanced liver disease, specifically cirrhosis and ascites. The company relies on a combination of patent, trade secret, other intellectual property laws, nondisclosure agreements, and other measures to protect its proposed products with a layered strategy, and it requires employees, consultants, and advisors to execute confidentiality agreements.

The company's neurodegenerative disease programs are centered on bezisterim, the approved generic name for NE3107, 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. Bezisterim is being evaluated in Parkinson's disease, Alzheimer's disease, and long COVID. In Parkinson's disease, the company conducted a Phase 2b SUNRISE-PD clinical trial evaluating bezisterim (20 mg twice daily) in 57 patients with early-stage PD who were naïve to symptomatic dopaminergic therapy. The trial successfully met its prespecified primary endpoint, with bezisterim demonstrating a statistically significant reduction in the composite neuroinflammation measure, changing by -0.28 in patients treated with bezisterim compared with +0.19 for placebo (Cohen's d =-1.06, nominal p=0.0018) ¹. The majority of patients treated with bezisterim showed improvement on the Early Parkinson's Neuro-Inflammatory Composite 15 (EPNIC-15), a composite endpoint encompassing 15 clinically relevant motor and non-motor measures of PD, with bezisterim = -0.04 and placebo = +0.18 (Cohen's d = -0.94, nominal p=0.0006) ². Bezisterim was well tolerated and demonstrated a safety profile comparable to placebo, with the incidence of adverse events similar between treatment groups (39.3% with bezisterim vs. 51.7% with placebo) ³. In Alzheimer's disease, the company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial of bezisterim in the treatment of mild to moderate AD. After patient exclusions due to significant deviation from protocol and current good clinical practices violations at 15 study sites, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population ⁴. The trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms ⁵. In the Per-Protocol population, an observed descriptive change from baseline appeared to suggest a slowing of cognitive decline, and these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic changes using the Horvath DNA methylation Skin Blood Clock. In long COVID, the company was awarded a clinical trial grant of $13.1 million from the U.S. Department of War, awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs ⁶. 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 and completed enrollment in May 2026, and the company currently expects to report topline results in late summer of 2026.

The company's liver cirrhosis program is centered on BIV201 (continuous infusion terlipressin), which was granted both FDA Fast Track status and FDA Orphan Drug designation for ascites (due to all etiologies except cancer). BIV201 is being evaluated as a treatment option for patients suffering from life-threatening complications of liver cirrhosis and ascites due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually and have an estimated 50% mortality rate within 6 to 12 months ⁷. The FDA has never approved any drug specifically for treating ascites. In March 2023, enrollment was paused in the Phase 2 study, and data from the first 15 patients treated with BIV201 plus standard-of-care appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment ⁸. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period ⁹. The company's proprietary novel liquid formulation of terlipressin is designed to improve convenience for outpatient administration and avoid potential formulation errors when pharmacists reconstitute the current powder version of terlipressin. To date, analytical testing results have confirmed room temperature stability of the prefilled syringe in storage for up to two years ¹⁰. Patients with cirrhosis and ascites account for an estimated 116,000 U.S. hospital discharges annually, with frequent early readmissions ¹¹. In an analysis of the 2018 HCUP Nationwide Readmissions Database, patients hospitalized with cirrhosis, ascites and paracentesis had an average length of stay of 8.0 days and average hospital charges of $89,136 per admission ¹². This translates into a total potentially addressable ascites market size for BIV201 therapy exceeding $650 million based on Company estimates ¹³. After receiving guidance from the FDA in 2023 and again in 2025, the company is currently finalizing the protocol design for a 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 acute kidney injury.

On August 11, 2025, the company closed an underwritten public offering of 5,620,000 units, with each unit consisting of one share of common stock and one warrant, and 380,000 pre-funded units, with each pre-funded unit consisting of one pre-funded warrant and one warrant ¹⁴. The underwriter also exercised its over-allotment option in part and purchased an additional 667,300 warrants ¹⁵. The offering resulted in net proceeds of approximately $10.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses ¹⁶. Each unit was sold to the public at a price of $2.00 per unit and each pre-funded unit was sold to the public at a price of $1.9999 per pre-funded unit ¹⁷. Each warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an exercise price of $2.50 per share and expires five years from the date of issuance ¹⁸. Upon closing, the company issued the underwriter warrants to purchase 300,000 shares of Common Stock exercisable at a per share price of $2.50, which was equal to 125% of the public offering price per share ¹⁹. The company also has warrants outstanding to purchase an aggregate of 8,282,037 shares (including 380,000 pre-funded warrants) of its Common Stock at exercise prices ranging from $2.50 to $582.00 per share, 2,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.31 to $774.00 per share, and restricted stock units totaling 300 ²⁰. The company is obligated to issue shares of its Common Stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of its drug candidates, which could result in the issuance of up to 180,000 shares of its Common Stock ²¹. The company is currently subject to securities class action litigation, with a consolidated action captioned In re BioVie Inc. Securities Litigation, No. 3:24-cv-00035, filed in the U.S. District Court for the District of Nevada, and three shareholder derivative lawsuits consolidated under the caption In re BioVie Inc. Derivative Litigation, Case No. 3:24-cv-0602-CSD. The insurance coverage for these actions is subject to a $2 million deductible ²².

The net loss for the year ended June 30, 2026 was approximately $22.1 million as compared to the net loss of $17.5 million for the year ended June 30, 2025 ²³. Total operating expenses for the years ended June 30, 2026 and 2025 were approximately $22.7 million and $18.1 million, respectively ²⁴. Research and development expenses were approximately $14.0 million for the year ended June 30, 2026, an increase of approximately $4.7 million from $9.3 million for the year ended June 30, 2025 ²⁵. General and administrative expenses were approximately $8.5 million and $8.6 million for the year ended June 30, 2026 and 2025, respectively ²⁶. Other income, net was approximately $579,000 for the year ended June 30, 2026 compared to other income, net of $524,000 for the year ended June 30, 2025 ²⁷. As of June 30, 2026, the company had working capital of approximately $9.8 million, cash and cash equivalents of approximately $9.0 million, stockholders' equity of approximately $10.3 million, and an accumulated deficit of approximately $374.3 million ²⁸. The company had net cash used in operating activities of approximately $19.0 million during the year ended June 30, 2026 ²⁹.

A major growth vector is the Parkinson's disease program for bezisterim. The company intends to use the topline results from the Phase 2b SUNRISE-PD clinical trial, which successfully met its prespecified primary endpoint with a statistically significant reduction in the composite neuroinflammation measure (Cohen's d =-1.06, nominal p=0.0018) ³⁰, to inform the design of a potentially pivotal Phase 3 registrational trial of bezisterim in PD. The trial evaluated bezisterim in 57 patients with early-stage PD who were naïve to symptomatic dopaminergic therapy ³¹. The company believes bezisterim could, if approved by the FDA, represent an entirely new medical approach to treating Parkinson's disease, which affects an estimated 1 million Americans ³².

Another major growth vector is the long COVID program for bezisterim. The company was awarded a clinical trial grant of $13.1 million from the U.S. Department of War, awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs ³³. 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 and completed enrollment in May 2026, and the company currently expects to report topline results in late summer of 2026. The company believes bezisterim could address a market of approximately 20 million adults in the US suffering from Long COVID, with millions more affected worldwide ³⁴.

The company's margin and cost outlook is not explicitly discussed in the filing, but the company's operating expenses are expected to continue as it advances its clinical programs. Research and development expenses increased by approximately $4.7 million from $9.3 million to $14.0 million for the year ended June 30, 2026, attributed to increased activities in both the Sunrise PD Phase 2 study and the Long COVID Phase 2 study ³⁵. General and administrative expenses decreased by approximately $59,000 from $8.6 million to $8.5 million ³⁶. The company has not generated any revenues to date and no revenues are expected in the foreseeable future, and its future operations are dependent on the success of its ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed ³⁷.

The company's operational outlook includes reliance on third parties for clinical trials and manufacturing. The company depends on contract research organizations, clinical trial sites, clinical trial principal investigators, contract laboratories, independent institutional review boards, manufacturers, suppliers, and other third parties to conduct its clinical trials. The company has contracted with an experienced Contract Manufacturing Organization to perform the manufacturing of its investigational product candidates BIV201 and bezisterim. The company has 13 employees which are all full time ³⁸. The company's San Diego office lease at 5090 Shoreham Place Suite 206, San Diego, CA 92122 was amended on February 12, 2024 for a larger space, with a current monthly base rate of $10,375, with an annual increase of four percent, and a term of 60 months ³⁹. The company pays an annual rent of $2,200 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703 ⁴⁰.

The company's capital allocation strategy includes raising substantial additional capital to fund its operations. As of June 30, 2026, the company had cash and cash equivalents of approximately $9.0 million ⁴¹. The company completed an underwritten public offering on August 11, 2025, resulting in net proceeds of approximately $10.5 million ⁴². The company has warrants outstanding to purchase an aggregate of 8,282,037 shares (including 380,000 pre-funded warrants) of its Common Stock at exercise prices ranging from $2.50 to $582.00 per share, 2,785,363 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.31 to $774.00 per share, and restricted stock units totaling 300 ⁴³. The company is obligated to issue shares of its Common Stock upon achievement of certain clinical, regulatory and commercial milestones, which could result in the issuance of up to 180,000 shares of its Common Stock ⁴⁴. The company does not anticipate paying any cash dividends on its Common Stock in the foreseeable future ⁴⁵.

A structural headwind flagged by management is the company's need to raise substantial additional capital to fund its operations. The company has not generated any revenues to date and no revenues are expected in the foreseeable future, and its future operations are dependent on the success of its ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed ⁴⁶. The company's recurring losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern ⁴⁷. The company's fixed expenses, such as rent and other contractual commitments, will likely increase in the future, as it may enter into leases for new facilities and capital equipment and/or enter into additional licenses and collaborative agreements ⁴⁸.

A regulatory and execution risk flagged by management is the company's reliance on third parties to conduct its clinical trials. The company depends on contract research organizations, clinical trial sites, clinical trial principal investigators, contract laboratories, independent institutional review boards, manufacturers, suppliers, and other third parties to conduct its clinical trials. The company's drug product candidate bezisterim was cleared by FDA for use in a Phase 3 clinical trial in mild to moderate AD, but upon trial completion, the company found significant deviations from the protocol and current good clinical practices violations at 15 study sites, which led the company to exclude all patients from these sites and refer the sites to the FDA Office of Scientific Investigations for potential further action ⁴⁹. The unplanned exclusion of so many patients left the trial underpowered for its primary endpoints ⁵⁰. The company is also subject to securities class action litigation, which will require significant management time and attention, result in significant legal expenses, and may result in unfavorable outcomes ⁵¹.

Management's message to shareholders emphasizes the company's progress in advancing its clinical programs, particularly the successful topline results from the Phase 2b SUNRISE-PD clinical trial of bezisterim in Parkinson's disease, which met its prespecified primary endpoint with a statistically significant reduction in the composite neuroinflammation measure (Cohen's d =-1.06, nominal p=0.0018) ⁵⁷. Management intends to use these results to inform the design of a potentially pivotal Phase 3 registrational trial of bezisterim in PD. The company also highlights the progress of its long COVID program, with the Phase 2 ADDRESS-LC study having completed enrollment in May 2026 and topline results expected in late summer of 2026. For the liver cirrhosis program, management notes that after receiving guidance from the FDA in 2023 and again in 2025, the company is currently finalizing the protocol design for a Phase 3 study of BIV201. The strategic priorities emphasized for the period ahead include advancing bezisterim through clinical development for Parkinson's disease and long COVID, finalizing the Phase 3 protocol for BIV201 in liver cirrhosis, and securing additional financing to fund operations, as the company has not generated any revenues to date and no revenues are expected in the foreseeable future ⁵⁸.

For the year ended June 30, 2026, the company reported a net loss of approximately $22.1 million compared to a net loss of $17.5 million for the year ended June 30, 2025 ⁵⁹. Total operating expenses were approximately $22.7 million for fiscal 2026 versus $18.1 million for fiscal 2025 ⁶⁰. Research and development expenses were approximately $14.0 million for fiscal 2026, an increase of approximately $4.7 million from $9.3 million in fiscal 2025 ⁶¹. General and administrative expenses were approximately $8.5 million for fiscal 2026 compared to $8.6 million for fiscal 2025 ⁶². Other income, net was approximately $579,000 for fiscal 2026 compared to $524,000 for fiscal 2025 ⁶³. As of June 30, 2026, the company had cash and cash equivalents of approximately $9.0 million, working capital of approximately $9.8 million, stockholders' equity of approximately $10.3 million, and an accumulated deficit of approximately $374.3 million ⁶⁴. Net cash used in operating activities was approximately $19.0 million during fiscal 2026 ⁶⁵. The company has not generated any revenues to date and has no products approved for commercial sale ⁶⁶. The company's net loss increase of $4.6 million was primarily attributed to an increase in operating expenses of $4.6 million, offset by a net increase in other income, net of approximately $55,000 ⁶⁷. The increase in R&D expenses of approximately $4.7 million was attributed to increases in direct study costs of approximately $4.5 million, clinical team compensation of approximately $686,000, and abstracts, publications and conferences of approximately $141,000, offset by approximately $646,000 in Chemistry, Manufacturing and Controls and Discovery expenses that were curtailed ⁶⁸. The increase in clinical studies of approximately $4.5 million was attributed to increased activity in both clinical studies, with Sunrise PD Phase 2 study costs increasing by approximately $4.0 million and Long Covid Phase 2 study activities increasing by approximately $709,000 net of reimbursements ⁶⁹. Grant reimbursements recognized for the corresponding research and development expenses totaled approximately $7.6 million and $5.3 million for the years ended June 30, 2026 and 2025, respectively ⁷⁰.

The company has no products approved for commercial sale, has never generated any revenues, and may never achieve revenues or profitability, which could cause it to cease operations ⁵². The company will need to raise substantial additional capital to fund its operations, and if adequate funds are not available, it may be required to delay, reduce the scope of, or eliminate one or more of its research or development programs or its commercialization efforts ⁵³. The company's recurring losses from operations and negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern ⁵⁴. The company is currently subject to securities class action litigation, with insurance coverage subject to a $2 million deductible, which means the company is responsible for the first $2 million of loss arising from these actions, including both defense costs and damages, before any insurance coverage applies ⁵⁵. The company relies on third parties to conduct its clinical trials, and if these third parties do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, the company may not be able to obtain regulatory approval of or commercialize its product candidates, as evidenced by the significant deviations from protocol and current good clinical practices violations at 15 study sites in the Phase 3 Alzheimer's disease trial, which led to the exclusion of all patients from these sites and left the trial underpowered for its primary endpoints ⁵⁶.