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- Going Concern (new) — The company states substantial doubt about its ability to continue as a going concern due to lack of revenue and insufficient financing; the auditor's report includes an explanatory paragraph on this matter.
- Product Liability (new) — Securities class action litigation alleges material misrepresentations about the Phase 3 Alzheimer's trial; court denied motion to dismiss and certified the class, creating ongoing legal and financial exposure.
BioVie (BIVI) files for best-efforts offering at $1.77/share with no minimum proceeds
Filed July 17, 2026 · ~2 min read
Key Changes
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Best-efforts offering of Common Stock at last reported Nasdaq price ($1.77 on July 15, 2026) with no minimum proceeds threshold; company could raise substantially less than target or nothing at all.
The Offering verify on EDGAR → -
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Net proceeds of $10.5M will fund working capital and general corporate purposes including R&D, capex, and potential acquisitions; management has broad discretion over allocation.
Use of Proceeds verify on EDGAR → -
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GAAP net loss of $16.4M for the nine months ended March 31, 2026, up from $14.1M in the prior-year period, driven by increased R&D spending on Parkinson's and long COVID trials.
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Phase 3 Alzheimer's trial compromised by protocol violations at 15 sites; all patients from those sites excluded, leaving only 81 patients versus 250 planned, rendering trial underpowered.
Prospectus Summary verify on EDGAR → -
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Securities class action alleging material misrepresentations about the Alzheimer's trial; court denied motion to dismiss in March 2025 and certified class in June 2026.
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Large warrant overhang: 8,282,037 shares underlying outstanding warrants (more than the 7,541,839 shares currently outstanding) at weighted average exercise price of $5.56.
Dilution verify on EDGAR → -
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Cash position of $13.1M as of March 31, 2026, down from $17.5M at June 30, 2025; company used $14.9M in operating activities during the nine-month period.
Summary
BioVie, a clinical-stage biopharmaceutical company developing treatments for neurodegenerative diseases and liver cirrhosis complications, has filed to raise capital through a best-efforts offering of Common Stock priced at the last reported Nasdaq price of $1.77 per share (as of July 15, 2026).
The offering has no minimum proceeds threshold, meaning the company could raise substantially less than the estimated $10.5M in net proceeds or potentially nothing at all. Proceeds will fund working capital and general corporate purposes including R&D, capital expenditures, and potential acquisitions, with management retaining broad discretion over allocation.
The company reported a GAAP net loss of $16.4M for the nine months ended March 31, 2026, compared to $14.1M in the prior-year period, driven by increased R&D spending on its Parkinson's and long COVID trials. As of March 31, 2026, BioVie had cash of $13.1M and working capital of $15.2M, down from $17.5M and $18.4M respectively at June 30, 2025. The company has never generated revenue and faces substantial doubt about its ability to continue as a going concern, as noted by both management and the auditor. The implied post-offering market capitalization is not calculable from this preliminary filing as the offering price and share count are incomplete. BioVie faces significant clinical and legal headwinds. Its Phase 3 Alzheimer's trial was compromised by protocol violations at 15 sites, forcing exclusion of those patients and leaving only 81 patients versus the 250 planned, rendering the trial underpowered for its primary endpoints. The company faces securities class action litigation alleging material misrepresentations about this trial; the court denied the motion to dismiss in March 2025 and certified the class in June 2026. The company also notes it has identified material weaknesses in internal controls in the past and may do so again. The company carries a large warrant overhang of 8,282,037 shares (more than currently outstanding) at a weighted average exercise price of $5.56, well above the current $1.77 market price.
Section-by-Section Diff
The Offering · The Offering
Best-efforts offering of Common Stock at last reported Nasdaq price, with Pre-funded Warrants available to prevent >9.99% ownership; no minimum proceeds.
Added in current filing · verify on EDGAR →
We are offering on a “best efforts” basis up to shares (the “Shares”) of Class A Common Stock, par value $0.0001 per share (the “Common Stock”) at an assumed public offering price of $ per Share, the last reported sales price of our Common Stock as reported on The Nasdaq Capital Market (“Nasdaq”) on July , 2026.
The company is conducting a best-efforts offering of Common Stock priced at the last reported Nasdaq sales price on July [blank], 2026. The number of shares and price per share are not yet filled in this preliminary filing. A best-efforts offering means the placement agent is not committed to sell any specific amount.
Added in current filing · verify on EDGAR →
We are also offering up to Pre-funded Warrants to purchase up to shares of Common Stock at an assumed public offering price equal to the price per Share being sold to the public in this offering minus $0.0001, to those purchasers whose purchase of Shares in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 9.99% of our outstanding Common Stock immediately following the consummation of this offering. The Pre-funded Warrants will be immediately exercisable and may be exercised at any time until exercised in full at an exercise price of $0.0001 per share.
The company is offering Pre-funded Warrants as an alternative to direct share purchases for buyers who would otherwise exceed 9.99% ownership. These warrants are immediately exercisable at $0.0001 per share and priced at the public offering price minus $0.0001. Each Pre-funded Warrant sold reduces the number of Shares offered on a one-for-one basis.
Added in current filing · verify on EDGAR →
However, this is a best efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, and we may not sell all or any of the securities offered pursuant to this prospectus; as a result, we may receive significantly less in net proceeds.
The offering has no minimum threshold for closing, meaning the company could raise substantially less than the maximum amount or potentially nothing at all. This creates uncertainty around the actual capital the company will receive.
Added in current filing · verify on EDGAR →
We intend to use the net proceeds from this offering for working capital and general corporate purposes. This may include, but is not limited to, capital expenditures, research and development (“R&D”) expenditures and acquisitions of new technologies or businesses.
Proceeds will be used for working capital and general corporate purposes, including potential capital expenditures, R&D, and acquisitions. The broad language provides management with wide discretion over how funds are deployed.
Added in current filing · verify on EDGAR →
There is no established trading market for the Pre-funded Warrants. We do not intend to list the Pre-funded Warrants on any securities exchange or nationally recognized trading system and do not expect a trading market to develop for the Pre-funded Warrants.
The Pre-funded Warrants will not be listed on any exchange and no trading market is expected to develop, meaning holders will have no liquidity for these instruments other than exercising them for Common Stock.
Prospectus Summary · Prospectus Summary
Clinical-stage company developing bezisterim for neurodegenerative diseases (Parkinson's, Alzheimer's, long COVID) and BIV201 for liver cirrhosis complications.
Added in current filing · verify on EDGAR →
The trial commenced in April 2025 and completed enrollment of 60 patients in December 2025. The Company currently expects to report topline results from the trial late summer 2026
The company's Phase 2b trial of bezisterim as first-line therapy for newly diagnosed Parkinson's disease patients (who have not been treated with carbidopa/levodopa) enrolled 60 patients between April and December 2025. Topline results are expected late summer 2026, though timing is subject to change and favorable results are not assured.
Added in current filing · verify on EDGAR → · paraphrased
In April 2024, the Company was awarded a clinical trial grant of $13.1 million from the U.S. Department of War ("DOW"), formerly known as the Department of Defense, awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. [...] The trial commenced in May 2025 and completed enrollment in May 2026.
The company received a $13.1 million grant from the Department of Defense in April 2024 for its Phase 2 ADDRESS-LC trial evaluating bezisterim for long COVID neurological symptoms. The trial enrolled patients between May 2025 and May 2026. This non-dilutive funding supports development in a condition affecting approximately 20 million U.S. adults.
Added in current filing · verify on EDGAR →
Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from protocol and current 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 FDA 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
The company's Phase 3 Alzheimer's trial, originally designed for 250 patients (125 per arm), was compromised by protocol violations at 15 sites concentrated in one geographic area. All patients from these sites were excluded and referred to FDA investigators. This left only 81 patients in the analysis population versus the 250 planned, rendering the trial underpowered for its primary endpoints (ADAS-Cog 12 and CDR-SB).
Added in current filing · verify on EDGAR →
After receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is 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 acute kidney injury (“AKI”).
The company is finalizing the Phase 3 protocol for BIV201 (continuous infusion terlipressin) for liver cirrhosis and ascites following FDA guidance. The trial will target patients who recently recovered from acute kidney injury, using a composite endpoint of complications and disease progression. BIV201 has FDA Fast Track status and Orphan Drug designation for ascites; no drug is currently FDA-approved specifically for treating ascites.
Use of Proceeds · Use of Proceeds
Net proceeds will fund working capital and general corporate purposes including R&D, capex, and potential acquisitions; no minimum offering amount.
Added in current filing · verify on EDGAR →
However, this is a best efforts offering with no minimum number of securities or amount of proceeds as a condition to closing, and we may not sell all or any of the securities offered pursuant to this prospectus; as a result, we may receive significantly less in net proceeds.
This is a best-efforts offering with no minimum threshold, meaning the company could raise substantially less than the estimated proceeds or potentially nothing at all. Unlike a firm-commitment underwriting, there is no floor on the capital raised.
Added in current filing · verify on EDGAR →
Our management will have broad discretion in the application of the net proceeds from this offering and could use them for purposes other than those contemplated at the time of this offering. Our stockholders may not agree with the manner in which our management chooses to allocate and spend the net proceeds.
Management has broad discretion to allocate proceeds differently than the stated uses (working capital, R&D, capex, acquisitions). The filing explicitly acknowledges stockholders may disagree with how proceeds are spent and that uses may not positively impact results or stock value.
Show 1 minor / wording change
Added in current filing · verify on EDGAR →
We have never declared or paid dividends on our Common Stock and we do not anticipate paying any cash dividends on our Common Stock in the foreseeable future.
The company has never paid dividends and does not plan to do so in the foreseeable future, intending instead to retain all earnings to fund business development and growth.
Dilution · Dilution
Dilution table incomplete; 7,541,839 shares outstanding as of March 31, 2026, with 11,068,499 additional shares underlying options, warrants, and RSUs.
Added in current filing · verify on EDGAR →
7,541,839 shares of our Common Stock outstanding as of March 31, 2026
The company had 7,541,839 shares of Common Stock outstanding as of March 31, 2026. This is the baseline before the offering; the dilution table itself is incomplete (dollar amounts and per-share figures are blank placeholders).
Added in current filing · verify on EDGAR →
2,785,363 shares of our Common Stock issuable upon the exercise of outstanding stock options at a weighted average exercise price of $7.62 per share
2,785,363 shares are issuable upon exercise of outstanding stock options at a weighted average exercise price of $7.62 per share. These are excluded from the outstanding-share count and represent potential dilution if exercised.
Added in current filing · verify on EDGAR →
8,282,037 shares (including 380,000 pre-funded warrants) of our Common Stock issuable upon the exercise of outstanding warrants at a weighted average exercise price of $5.56 per share
8,282,037 shares (including 380,000 pre-funded warrants) are issuable upon exercise of outstanding warrants at a weighted average exercise price of $5.56 per share. This is a large overhang — more shares than currently outstanding — and represents significant potential dilution.
Added in current filing · verify on EDGAR →
On July 15, 2026, the last reported sales price of our Common Stock on Nasdaq was $1.77 per share.
The Common Stock closed at $1.77 per share on Nasdaq on July 15, 2026. This is the reference price for the offering; the dilution table references this price but does not fill in the resulting per-share dilution figures.
Risk Factors · Risk Factors
BIOVIE faces clinical trial failures, securities litigation, no revenue, going-concern doubt, and reliance on third parties for development.
Added in current filing · verify on EDGAR →
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. We subsequently 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.
BIOVIE's Phase 3 Alzheimer's trial for bezisterim (NE3107) suffered significant protocol deviations and GCP violations at 15 study sites, forcing exclusion of those patients and leaving the trial underpowered for its primary endpoints. The company notified FDA's Office of Scientific Investigations of the suspected improprieties.
Added in current filing · verify on EDGAR → · paraphrased
On January 19, 2024, a purported securities 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 us and certain of our 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 (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.
BIOVIE faces consolidated securities class action litigation alleging material misrepresentations regarding the Phase 3 bezisterim trial in Alzheimer's disease. The court denied defendants' motion to dismiss in March 2025 and certified the class in June 2026. The company has a $2 million insurance deductible before coverage applies.
Added in current filing · verify on EDGAR →
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 foregoing objectives.
BIOVIE has no approved products, has never generated revenue, and faces substantial doubt about its ability to continue as a going concern. Revenue depends on successful clinical trials, regulatory approvals, commercialization, and market acceptance — none of which are assured.
Added in current filing · verify on EDGAR →
Mallinckrodt Hospital Products IP Limited received Orphan Drug designation in 2004 for terlipressin for the treatment of Hepatorenal Syndrome (HRS). Mallinckrodt has already gained FDA approval for its product, lyophilized terlipressin acetate for bolus intravenous administration for the treatment of HRS Type 1 in September 2022.
Mallinckrodt received FDA approval in September 2022 for terlipressin (the same active ingredient as BIOVIE's BIV201) for hepatorenal syndrome Type 1, creating direct competition in one of BIOVIE's target indications despite BIOVIE's orphan drug designation.
Added in current filing · verify on EDGAR →
We are an early stage development company with limited resources. Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff at this early stage of operations to sell products. We cannot generate sales without sales or marketing staff and must rely on others to provide any sales or marketing services until such personnel are secured, if ever.
The company states it has no sales or marketing staff and no products available for sale. It must rely on third parties for any sales/marketing services until it hires such personnel, if ever. Failure to hire and retain sales staff could force the company to cease operations.
Added in current filing · verify on EDGAR →
We currently depend upon the efforts and abilities of our executive and senior management team of Cuong Do, our Chief Executive Officer-President; Wendy Kim, our Chief Financial Officer; Dr. Joseph Palumbo, our Executive Vice President - Chief Medical Officer; Penelope Markham, our Senior Vice President - Liver Disease and Long COVID Programs; Chris Reading, our Senior Vice President - Alzheimer’s Disease Program; Clarence Ahlem, our Senior Vice President - Operations; 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 company depends on seven named executives serving full-time. Loss of any of these individuals could have a material adverse effect on the business. The company has not obtained key-person life insurance on any of them.
Added in current filing · verify on EDGAR →
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.
The company names specific competitors: Ocelot Bio developing therapies for liver cirrhosis complications that may compete with BIV201, and Biogen and Eli Lilly developing AD/PD treatments that may compete with bezisterim (NE3107). Even if approved, there is no guarantee doctors will adopt the company's products over current treatment procedures.
Added in current filing · verify on EDGAR →
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.
This means there is a reasonable possibility that a material misstatement in the company's annual or interim financial statements could occur and not be prevented or detected on a timely basis. This raises concerns about the reliability of the company's financial reporting.
MD&A · Management's Discussion and Analysis
BIOVIE reported a net loss of $5.3 million for Q3 2026 vs $2.8 million in Q3 2025, driven by increased R&D spending on Sunrise PD and Long COVID trials.
Added in current filing · verify on EDGAR →
Net loss for the three months ended March 31, 2026 was approximately $5.3 million as compared to the net loss of approximately $2.8 million for the three months ended March 31, 2025.
The company's net loss for the three months ended March 31, 2026 was approximately $5.3 million, an increase of $2.5 million from the prior-year quarter's $2.8 million loss. The increase was driven by higher R&D expenses of $1.9 million and higher general and administrative expenses of $565,000.
Added in current filing · verify on EDGAR →
Net loss for the nine months ended March 31, 2026 was approximately $16.4 million comparable to the net loss of approximately $14.1 million for the nine months ended March 31, 2025.
For the nine months ended March 31, 2026, the company reported a net loss of approximately $16.4 million, an increase of $2.3 million from the prior-year period's $14.1 million loss. The increase was driven by higher operating expenses of $2.5 million, partially offset by increased other income of $155,000.
Added in current filing · verify on EDGAR →
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.
Management states there is substantial doubt about the company's ability to continue as a going concern. The company has not generated revenue, expects none in the foreseeable future, and there is no assurance it will obtain sufficient financing on acceptable terms to fund continuing operations.
Added in current filing · verify on EDGAR →
As of March 31, 2026, the Company had working capital of approximately $15.2 million, cash and cash equivalents totaling approximately $13.1 million, stockholders’ equity of approximately $15.6 million, and an accumulated deficit of approximately $368.6 million.
As of March 31, 2026, the company had working capital of $15.2 million and cash of $13.1 million, down from $18.4 million and $17.5 million respectively at June 30, 2025. The accumulated deficit reached $368.6 million. For the nine months ended March 31, 2026, the company used $14.9 million in operating activities and raised $10.5 million in net proceeds from capital raises.
Added in current filing · verify on EDGAR →
On August 11, 2025, the Company closed an underwritten public offering (the “Offering”) of (i) 5,620,000 units (the “Units”), with each Unit consisting of one share of common stock and one warrant (the “Warrants”) and (ii) 380,000 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting of one pre-funded warrant and one Warrant. The underwriter also exercised its over-allotment option in part and purchased an additional 667,300 Warrants. The Offering resulted in net proceeds of approximately $10.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses. 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 $1.999 per Pre-Funded Unit
The company closed an underwritten public offering on August 11, 2025, selling 5,620,000 units at $2.00 per unit and 380,000 pre-funded units at $1.999 per unit, plus 667,300 warrants from partial over-allotment exercise. Net proceeds were approximately $10.5 million after underwriting discounts and expenses. Each warrant is exercisable at $2.50 per share and expires five years from issuance.
Business · Business
Clinical-stage company developing bezisterim for neurodegenerative diseases (PD, AD, long COVID) and BIV201 for liver cirrhosis complications.
Added in current filing · verify on EDGAR →
The trial commenced in April 2025 and completed enrollment of 60 patients in December 2025. The Company currently expects to report topline results from the trial late summer 2026
The company's Phase 2b trial of bezisterim as a first-line therapy for newly diagnosed Parkinson's patients (not yet on levodopa) enrolled 60 patients between April and December 2025. Topline results are expected late summer 2026, though timing is subject to change and there is no assurance of favorable results.
Added in current filing · verify on EDGAR →
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.
The company's Phase 2 ADDRESS-LC trial for long COVID (cognitive impairment and fatigue) commenced in May 2025 and completed enrollment in May 2026. This trial is funded by a $13.1 million grant from the Department of Defense awarded in April 2024.
Added in current filing · verify on EDGAR →
Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from 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 and to refer the sites to the 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
The company's Phase 3 Alzheimer's trial (NCT04669028) was designed for 125 patients per arm but after unblinding found protocol deviations and cGCP violations at 15 sites (nearly all from one geographic area). The company excluded all patients from those sites and referred them to the Office of Scientific Investigations. Only 81 patients remained in the modified intent-to-treat population (57 in per-protocol), leaving the trial underpowered for its primary endpoints.
Added in current filing · verify on EDGAR →
On January 19, 2024, a purported securities 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 Company and certain of its officers as defendants.
A securities class action was filed in January 2024 alleging material misrepresentations about the company's NM101 Phase 3 study and trial of bezisterim (NE3107) in Alzheimer's disease. The complaint covers purchasers of securities from December 7, 2022 through November 28, 2023 and seeks unspecified monetary damages. The court denied defendants' motion to dismiss in March 2025 and certified the class in June 2026.
Added in current filing · verify on EDGAR →
After receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of patients with cirrhosis and ascites, the Company is 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.
The company received FDA guidance in June 2023 and December 2024 on Phase 3 trial design for BIV201 (continuous infusion terlipressin) for cirrhosis and ascites. The company is finalizing a Phase 3 protocol with a composite primary endpoint of complications and disease progression in patients who recently recovered from acute kidney injury. BIV201 has FDA Fast Track status and Orphan Drug designation for ascites.
Added in current filing · verify on EDGAR →
To date patents have been granted in the U.S. (Patent No. 12,156,898), India (Patent No. 540813), Chile (Patent No. 68965), China (Patent No. ZL 202080050758.X), Japan (Patent No. 7579811), Australia (Patent No. 2020279395) and Mexico (Patent No. 432332).
The company's novel liquid formulation of terlipressin (BIV201) has been granted patents in seven jurisdictions: U.S., India, Chile, China, Japan, Australia, and Mexico. The formulation is designed for room-temperature storage (versus refrigeration required for other terlipressin products) and is a prefilled syringe format not available elsewhere globally.
Added in current filing · verify on EDGAR →
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
Three derivative suits were filed between December 2024 and September 2025 alleging that current and former officers and directors breached fiduciary duties by causing or failing to prevent the securities violations alleged in the class action.
Experts · Experts
EisnerAmper LLP audited the financials; their report includes an explanatory paragraph about substantial doubt concerning going concern.
Added in current filing · verify on EDGAR →
which report includes an explanatory paragraph about the existence of substantial doubt concerning the Company’s ability to continue as a going concern
The independent auditor EisnerAmper LLP has included an explanatory paragraph in their audit report expressing substantial doubt about BioVie's ability to continue as a going concern. This is a significant red flag indicating the company faces material uncertainty about its ability to meet obligations and continue operations over the next twelve months.
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Figures/quotes linked to EDGAR · Narrative written by AI · Aug 16, 2026 · How we verify