As filed with the Securities and Exchange Commission on March 13, 2026.

Registration No. 333-292936

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

AMENDMENT NO. 1

FORM S-1

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

OPTION THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

Delaware		2834		33-4884057
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

680 W Nye Lane, Suite 201

Carson City, Nevada 89703

(775) 888-1664

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Cuong Do
c/o BioVie Inc.

Chief Executive Officer

680 W Nye Lane, Suite 201

Carson City, Nevada 89703

(775) 888-3162

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Stephen E. Older, Esq.

Carly E. Ginley, Esq.

McGuireWoods LLP

1251 Avenue of the Americas, 20th Floor

New York, New York, 10020

(212) 548-2100

Jeffrey J. Fessler, Esq.

Stephen A. Cohen, Esq.

Sheppard, Mullin, Richter & Hampton LLP

30 Rockefeller Plaza

New York, New York 10112

(212) 653-8700

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information contained in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

SUBJECT TO COMPLETION

DATED MARCH 13, 2026

1,818,182 Shares

Common Stock

Option Therapeutics Inc.

This is the initial public offering of shares of common stock, $0.001 par value per share (our “common stock”) of Option Therapeutics Inc., a Delaware corporation, which is currently a wholly owned subsidiary of BioVie Inc., a Nevada corporation (“BioVie”). We are offering 1,818,182 shares of our common stock.

We anticipate that the initial public offering price of shares of our common stock will be between $10.00 and $12.00 per share. Prior to this offering, there has been no public market for our common stock. We intend to apply to list our common stock on NYSE American (“NYSE”) under the symbol “OPTN”. If our common stock is not approved for listing on NYSE, we will not consummate this offering.

In connection with this offering, we will issue shares of our common stock representing not more than 40% of our outstanding common stock, with BioVie maintaining ownership of at least 60% of our outstanding common stock. As a result, we will be a “controlled company” as defined under the corporate governance rules of NYSE upon completion of this offering and will be exempt from certain corporate governance requirements of such rules. See “Management - Controlled Company Exemption.”

We are an “emerging growth company” and a “smaller reporting company” under the federal securities laws and may elect to comply with certain reduced public company reporting requirements. See “Summary—Implications of Being an Emerging Growth Company and a Smaller Reporting Company.”

Investing in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 16.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

	Per Share	Total
Initial public offering price	$	$
Underwriting discounts and commissions⁽¹⁾	$	$
Proceeds to us, before expenses	$	$

(1)

We refer you to “Underwriting” beginning on page 100 for additional information regarding the underwriters’ compensation.

We have granted a 45-day option to the underwriters to purchase up to 272,727 additional shares of our common stock at the initial public offering price, less underwriting discounts and commissions, solely to cover over-allotments, if any.

The underwriters expect to deliver the shares to purchasers on or about , 2026.

ThinkEquity

The date of this prospectus is , 2026.

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS	1
FORWARD-LOOKING STATEMENTS	3
PROSPECTUS SUMMARY	4
RISK FACTORS	16
USE OF PROCEEDS	51
DIVIDEND POLICY	52
CAPITALIZATION	53
DILUTION	54
BUSINESS	56
THE SEPARATION TRANSACTION	66
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	67
MANAGEMENT	70
EXECUTIVE COMPENSATION	76
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS	81
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENTS	86
DESCRIPTION OF OUR SECURITIES	87
SHARES ELIGIBLE FOR FUTURE SALE	93
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES FOR NON-U.S. HOLDERS	96
UNDERWRITING	100
LEGAL MATTERS	107
EXPERTS	107
WHERE YOU CAN FIND MORE INFORMATION	107
INDEX TO FINANCIAL STATEMENTS	F-1

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement on Form S-1 that we filed with the U.S. Securities and Exchange Commission (the “SEC”). You should read this prospectus carefully. This prospectus contains important information you should consider when making your investment decision.

You should only rely on information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus that we may authorize to be delivered or made available to you. Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than the information contained in this prospectus, any amendment or supplement to this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we may have referred you. We and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the underwriters have not authorized any other person to provide you with different or additional information. Neither we nor the underwriters are making an offer to sell shares of our common stock in any jurisdiction where the offer or sale is not permitted. This offering is being made in the United States and elsewhere solely based on the information contained in this prospectus. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy our common stock in any circumstances under which such offer or solicitation is unlawful. The information contained in this prospectus, any amendment or supplement to this prospectus or any applicable free writing prospectus is current only as of its date, regardless of the time of delivery of this prospectus, any amendment or supplement to this prospectus or any applicable free writing prospectus or any sale of the shares. Our business, financial condition, results of operations and prospects may have changed since such date.

For investors outside the United States: neither we nor the underwriters have done anything that would permit this offering or the possession or distribution of this prospectus in any jurisdiction where action for those purposes is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, this offering of our common stock and the distribution of this prospectus outside the United States.

Background

In connection with this offering, we will issue 1,818,182 shares of our common stock (or 2,090,909 shares if the underwriters exercise their over-allotment option to purchase additional shares in full) representing not more than 40% of our outstanding common stock, with BioVie maintaining ownership of at least 60% of our outstanding common stock. We describe in this prospectus the business that will be contributed to us by BioVie as part of our separation from BioVie as if it were our business for all historical periods described.

Except as otherwise indicated, references in this prospectus to (1) the “Separation” refer to the separation of our business from BioVie’s business, along with the effectiveness of various agreements between us and BioVie and (2) the “Company,” “Option,” “we,” “us” and “our” refer to Option Therapeutics Inc., a Delaware corporation, assuming the completion of the Separation; and (3) “BioVie” refer to BioVie Inc., a Nevada corporation.

Please see the section titled “The Separation Transaction” for a description of the Separation.

Market, Industry and Other Data

This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.

In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Forward-Looking Statements.”

Presentation of Financial Information

The financial information included in this prospectus has been prepared from BioVie’s historical accounting records and is derived from the financial statements of BioVie to present the Company as if it had been operating on a standalone basis. The historical carve-out financial statements (together with the notes thereto, the “financial statements”) reflect our financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The carve-out financial statements include the assets, liabilities, and expenses based on our legal entity structure as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are partially provided on a centralized basis by BioVie, which include finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance, and other professional services. Indirect costs have been allocated to us for the purposes of preparing the carve-out financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on individuals identified that contributed to the Company’s operations or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or the benefit received by us during the periods presented, depending on the nature of the services received.

The financial information included in this prospectus may not necessarily reflect what our financial condition, results of operations, or cash flows would have been had we been a standalone company during that will occur in our operations and capital structure as a result of this offering and the Separation. In addition, the financial information included in this prospectus may not necessarily reflect what our financial condition, results of operations, and cash flows may be in the future. See “Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—We have no recent history of operating as a standalone public company, and our historical financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future.”

FORWARD-LOOKING STATEMENTS

Certain statements contained in this prospectus constitute forward-looking information or forward-looking statements under applicable securities laws. These statements relate to future events or future performance, business prospects or opportunities of the Company. All statements other than statements of historical fact may be forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, or future events or performance (often, but not always, using words or phrases such as “seek,” “anticipate,” “plan,” “continue,” “estimate,” “expect,” “may,” “will,” “project,” “predict,” “forecast,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar expressions) are not statements of historical fact and may be “forward-looking statements.”

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward-looking statements. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. These forward-looking statements involve risks and uncertainties relating to, among others: our limited operating history; our ability to raise the substantial capital needed to fund our operations and research and development; risks associated with clinical development and our ability to successfully complete pre-clinical and clinical testing and be granted regulatory approval for our products to be sold and marketed in the United States or elsewhere; our ability to achieve the expected benefits of and successfully execute the Separation; our status as a controlled company, and the possibility that BioVie’s interests or those of certain of our executive officers and directors may conflict with the interests of our other stockholders; our reliance on third parties to conduct our clinical trials and manufacture our product candidates; our ability to establish and/or maintain intellectual property rights covering our product candidates; competition; future dilution and liquidity of our common stock; the global economic, political and financial market conditions; and our reliance on a limited number of product candidates.

The Company believes that the expectations reflected in any forward-looking statements are reasonable, but no assurance can be given that these expectations will prove to be correct and such forward-looking statements included in, or incorporated by reference into, this prospectus should not be unduly relied upon. These statements speak only as of the date of this prospectus and the Company does not intend, and does not assume any obligation, to update these forward-looking statements, except as required by law. Actual results may differ materially from those expressed or implied by such forward-looking statements.

PROSPECTUS SUMMARY

This summary contains basic information about us and our business but does not contain all of the information that is important to your investment decision and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. You should carefully read this summary together with the more detailed information contained elsewhere in this before making an investment decision. Investors should carefully consider the information set forth under the caption “Risk Factors” appearing elsewhere in this prospectus.

Overview

We are a clinical-stage company developing innovative drug therapies to treat debilitating and life-threatening liver disease through our investigational drug candidate BIV201 (continuous infusion terlipressin). BIV201 has been granted both Food and Drug Administration (“FDA”) Fast Track designation status and FDA Orphan Drug Status, which designations provide certain advantages in the review process, but do not guarantee a faster development process, regulatory review or approval as compared to the conventional FDA review and approval process. BIV201 is being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by metabolic dysfunction-associated steatohepatitis (“MASLD”), hepatitis, and alcoholism. BIV201 is designed to be administered as a patented liquid formulation of terlipressin with patents issued, to date, in the U.S., Australia, China, Japan, Chile, and India, and with seven pending patent applications in the U.S. and other jurisdictions. Also, we own U.S. Patent No. 11,364,277, and European Patent No. EP3347032, which are directed to a method of treating ascites with BIV201, and we are pursuing additional patent coverage in the U.S., Japan, Europe, and China.

About Liver Cirrhosis

Liver cirrhosis causes a heavy global burden. There are an estimated 4.5 million people diagnosed with chronic liver disease and cirrhosis in the United States and 52,259 deaths annually, ranking 9^th in causes of death. The condition results primarily from hepatitis, alcoholism, and fatty liver disease linked to obesity. Between 2012 and 2018, the prevalence of liver cirrhosis doubled among insured patients in the United States, alcohol-related and MASLD cirrhosis were the most significant contributors to this increase. Additionally, the number of deaths from alcoholic cirrhosis more than tripled between 1999 and 2019, rising from 3.3 deaths per 100,000 to 10.6 deaths per 100,000.

Individuals with cirrhosis are at high risk of developing complications which include ascites, variceal bleeding, hepatic encephalopathy, acute kidney injury (“AKI”), and bacterial infections, the development of which define decompensated cirrhosis, and the increased prevalence of cirrhosis is expected to result in increased incidence of cirrhosis complications. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. Decompensated cirrhosis is an advanced stage of cirrhosis often associated with liver failure and is associated with worse survival rates (2-4 years and 20 - 57% mortality in one year) compared with compensated cirrhosis (10-15 years and 1 - 3% mortality in one year). The majority of decompensated patients have ascites and are frequently hospitalized for complications. In 2014 approximately 100,000 individuals with cirrhosis and ascites were hospitalized in the United States with about 25,000 of those individuals being readmitted within 30 days. Assuming at least a continuing trend to double the prospective patient population per decade, as was seen from 2012 to 2018, the estimated target population is approximately 190,000 per year. Those with ascites and AKI experience higher readmission rates and have a poor prognosis. The development of AKI is strongly associated with mortality and can increase risk of death five-fold.

Decompensated liver cirrhosis currently has no approved therapeutic options other than liver transplantation. There is thus a major gap in effective, long-term, and accessible treatments for patients with decompensated liver disease and ascites. The paradigm for the treatment of these patients is now changing from attempts to control ascites towards the goal of preventing further decompensation and mortality. The recent news that the PRECIOSA Phase 3 study, sponsored by Grifols, S.A. which evaluated whether albumin infusions improve mortality, transplant-free survival, and disease-related outcomes in decompensated patients, failed to meet its primary endpoint, highlights the urgent need for more research and investment in this challenging population.

The Need for Therapy

A reduction in complications in decompensated patients could lead to a decrease in the risk of hospitalization, reducing health care burden and costs, and increase the chance of survival. In addition, these complications may make this population ineligible for liver transplantation. There is currently no approved drug treatment to reduce ascites and complications and preserve renal function in patients with cirrhosis and ascites. As noted above, the PRECIOSA Phase 3 study, which evaluated the potential for frequent albumin infusions to improve outcomes, transplant-free survival, mortality and complications in this patient population, failed to meet its primary endpoint.

U.S. treatment costs for liver cirrhosis, including ascites and other complications, are estimated at more than $5 billion annually. Treating decompensated cirrhosis and complications like ascites and AKI increase the costs of treatment significantly in the first year.

Pathophysiology of Decompensated Cirrhosis

Most experts agree that ascites and other complications develop as a consequence of high blood pressure in the vein that supplies blood to the liver. This so-called “portal hypertension” occurs as increasing liver damage (fibrosis) impedes blood flow through the liver. This causes vasodilation and blood pooling in the central or “splanchnic” region of the body and low blood volume in the arteries. The decrease in effective blood volume activates a signaling pathway (“neurohormonal systems”) which tells the kidneys to retain large amounts of salt and water in an effort to increase blood volume. Ultimately the retention of excess sodium and water leads to the formation of ascites as these substances “weep” from the liver and lymph system and collect in the patient’s abdomen as ascites. Portal hypertension also leads to the development of hepatic encephalopathy, gastrointestinal (“GI”) bleeding, and hepatorenal syndrome and increases the risk of AKI.

About BIV201

The vasoconstrictor terlipressin, an agonist of vasopressin receptors, reduces splanchnic vasodilation associated with portal hypertension in patients with cirrhosis and can lead to a decrease in ascites production by reducing portal hypertension, increasing effective blood volume and decreasing the activity of the renin-angiotensin-aldosterone system. Terlipressin was first approved in the early 1980s in Germany for the treatment of patients with bleeding esophageal varices (“BEV”) and, given the emergency setting for this indication, developed to be administered as a bolus injection. Products containing terlipressin have now been used for decades in over 40 non-U.S. countries to treat complications of liver cirrhosis (Type 1 hepatorenal syndrome (“HRS”) and BEV). In 2022, the FDA approved a terlipressin product (Terlivaz^®) as a lyophilized powder for bolus intravenous administration to improve kidney function in adults with HRS with rapid reduction in kidney function. The FDA-approved dosing for this product is limited to hospital administration via repeated IV bolus injections every six hours and the product label contains a black box warning of serious or fatal respiratory failure.

BioVie is developing BIV201, a room temperature stable liquid formulation of terlipressin, to be administered as a continuous IV infusion versus repeated IV bolus injections. BIV201 is currently designed to be injected into a bag of saline and attached to a standard infusion portable pump for continuous IV infusion treatment. BioVie’s clinical data indicates that administration of terlipressin by continuous infusion results in predictable pharmacokinetics [Bajaj 2022] that avoids high plasma peaks of this potent vasoconstrictor which is believed to contribute to adverse cardiovascular side effects [Cavallin 2016].

Since the commencement of the clinical development of BIV201 in 2016, there have been multiple published findings to support the use of continuous IV infusion of terlipressin for the management of cirrhotic patients with ascites. In addition to our previously reported data from our Phase 2a study (NCT03107091) [Bajaj 2022; Fischer 2019], and our Phase 2b study (NCT04112199) [Bajaj 2025], data from additional studies (Chapman 2019; Gow 2016; Gow 2020; Terbah 2024a; Terbah 2024b) show meaningful improvements in clinical outcomes, including extended intervals between paracenteses, decreased ascites volume, and lower incidence of further decompensation events. Most recently, a cross-over study in 30 patients treated on an outpatient basis for three months with terlipressin administered as a continuous infusion [Terbah 2024a and 2024b] further supports our belief that terlipressin, administered as a continuous infusion on an outpatient basis, has the potential to be a well-tolerated effective treatment to improve clinical outcomes in patients with cirrhosis requiring paracentesis, improving cardiac reserve, and attenuating the hyperdynamic state typically occurring in patients with decompensated cirrhosis.

By targeting the pathophysiology that predisposes these patients to AKI and by reducing potential triggers for AKI (paracentesis, spontaneous bacterial peritonitis (“SBP”), portal-hypertension-related GI bleeding and reduction in the need for diuretics), we believe BIV201 could potentially reduce ascites and the incidence of further decompensation events, including AKI, and subsequently improve patient outcomes. Thus, we believe that BIV201, for continuous IV infusion, with its novel room temperature stable liquid formulation in a pre-filled syringe (and other container presentations), could potentially provide a superior terlipressin drug delivery system with improved safety versus the approved bolus administration products.

BIV201 is a continuous infusion administration of terlipressin, in contrast to bolus injection administration of terlipressin. We believe that BIV201, for continuous IV infusion, with its novel room temperature stable liquid formulation in a pre-filled syringe (and other container presentations), could potentially provide a superior terlipressin drug delivery system with improved safety versus the approved bolus administration products.

Given the wealth of human experience with terlipressin in patients with decompensated cirrhosis in non-U.S. countries, BioVie was not required to conduct Phase 1 studies and initiated the clinical development of BIV201 with several proof-of-concept clinical studies (NCT03107091 and NCT04112199). BioVie received initial guidance from the FDA in June 2023 on the protocol design, study endpoints and regulatory relevance of a proposed Phase 3 definitive clinical trial. An additional discussion of the primary study efficacy endpoint was held with the FDA in March 2025. This Phase 3, randomized, controlled, open-label trial will evaluate the clinical benefit of BIV201 in patients with cirrhosis and ascites who have experienced a recent AKI, using a composite primary endpoint of disease progression and complications. The composite primary endpoint includes multiple clinically significant events, and we believe it has the advantage of demonstrating hard clinical outcomes and increasing the overall event rate, improving statistical power, and making the trial more feasible and cost effective. While a composite endpoint could obscure the response of a single definitive component of the endpoint, we believe the protocol’s planned secondary analysis of each component separately can sufficiently address this interpretation complexity. Details on the clinical protocol will be posted to the National Clinical Trials website for public reference at the initiation of the trial in accordance with applicable U.S. Code of Federal Regulations.

In an open-label Phase 2a proof-of-concept trial (NCT03107091) initiated by BioVie in 2017, six patients with cirrhosis and refractory ascites received a continuous IV infusion of terlipressin 2 mg/day escalating to 4 mg/d during a seven day inpatient period, followed by 21 days as outpatients. The PK and safety/tolerability and effects on the need for and volume of paracentesis were evaluated. Four of six patients enrolled experienced ≥50% increase in the interval between large volume paracenteses with terlipressin. Three (50.0%) patients experienced treatment-related adverse events, but none were serious adverse events (“SAEs”). Based on this study, continuous IV infusion of terlipressin improved control of refractory ascites with an acceptable safety and predictable PK profile and further evaluation of terlipressin was deemed warranted in a randomized controlled trial for treating refractory ascites and related complications of cirrhosis.

In June 2021, BioVie initiated a randomized (2:1), open-label Phase 2b study (NCT04112199) designed to evaluate the efficacy of BIV201 for the treatment of refractory ascites. Patients with cirrhosis and refractory ascites were randomly assigned (2:1) to receive two 28-day cycles of continuous infusion BIV201 plus standard of care (“SOC”) separated by a ≤56-day washout (n=10), or SOC alone (n=5).The primary endpoints of the study were the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period. The study was not designed for hypothesis testing, aiming instead to assess effect size and preliminary evidence of efficacy and safety, to enable more definitive estimation of the necessary number of points needed to definitively demonstrate improved efficacy and safety in Phase 3 testing. By October 2022, there were 15 patients enrolled for treatment. The Phase 2b study was closed before full enrollment (paused in March 2023 with last patient completing treatment on May 8, 2023) without clinically meaningful adverse effects associated with BIV201 treatment. While the study ended early given cost considerations, data from the first ten patients treated with BIV201 plus SOC 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. The change in ascites volume was significantly different from those patients receiving SOC treatment who experienced a 3.1% increase in ascites fluid. Patients who started the treatment with BIV201 but did not complete the treatment experienced a 15% reduction in ascites fluid. 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. The incidence of treatment emergent adverse events (“TEAEs”), including serious TEAEs, was similar in both treatment groups. The only SAE that was reported in greater than one patient in either group was hyponatremia, which was reported in two patients in the BIV201+SOC group and related to BIV201 treatment in one of the two patients. Final data analysis was limited by the small sample size and confounded by a potential interaction with gabapentinoids in the BIV201+SOC group. Nonetheless, though not meeting the primary endpoint, there were differences in favor of BIV201+SOC versus SOC in the coprimary efficacy endpoints and several QoL assessments. The beneficial effects of BIV201 on liver complications (mean: 90% CI; BIV201-completers=2.87: 1.51; 5.46 vs. SOC=2.38: 1.20; 4.73) and the change in cumulative ascites (mean; 90% CI; BIV201-completers=−10.76: −26.51; 5.00 vs. SOC=−4.99: −21.95; 11.97) were more pronounced versus SOC in the 5 BIV201+SOC patients who completed both treatment cycles. There were also greater improvements in exploratory QoL assessments and the percent change in TPs with BIV201+SOC (−27.94±41.80) versus SOC (−16.67±45.64). Despite the high rate of hyponatremia in the BIV201+SOC group (4/10 patients), the safety profile suggested that continuous BIV201 infusion was well tolerated. Cumulative safety data from the Phase 2a study (6 patients; 131 total days of BIV201 infusion) and Phase 2b study (10 patients; 379 total days of BIV201 infusion) further supported the safety and tolerability in this population with hyponatremia being the only SAE, related to terlipressin.

Our proprietary liquid formulation of terlipressin is intended to enhance convenience of use and to reduce the potential for formulation preparation errors with lyophilized terlipressin. To date, analytical testing performed by an independent laboratory has confirmed BioVie’s formulation, when packaged in prefilled syringes, to be shelf-stable under room temperature conditions for at least two years. BioVie submitted the data from such testing to the FDA for review. Room temperature stability in a liquid formulation represents a convenience and potential safety advantage for our product versus the currently available commercial formulations. To the best of the Company’s knowledge, all other terlipressin products sold globally must be stored under refrigeration and there is no prefilled syringe format of terlipressin available for treating patients in these countries. BioVie has also filed a Patent Cooperation Treaty (“PCT”) application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269, published as WO2020/237170). 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), and Australia (Patent No. 2020279395).

In addition, we own U.S. Patent No. 11,364,277, and European Patent No. EP3347032, which are directed to a method of treating ascites with BIV201, and we are pursuing additional patent coverage in the U.S., Japan, Europe, and China.

We believe BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis, and alcoholism. The FDA has granted Fast-Track status and Orphan Drug designation for ascites (due to all etiologies except cancer), which is the most common complication related to liver cirrhosis and represents a significant unmet medical need. BioVie estimates approximately 190,000 unique patients with cirrhosis and ascites are hospitalized annually in the United States based on data from 2014 and an estimated doubling of the population in the past 10 years. Assuming each of these patients experiences at least one AKI per year, the total addressable market is 190,000 patients. This translates into a total potentially addressable market size for BIV201 therapy exceeding $2.3 billion based on Company estimates. The agreed-upon approach for conducting the registrational Phase 3 could lead to earlier treatment of patients and expand the market opportunity versus the currently approved terlipressin product in the U.S, Terlivaz^®.

The BIV201 development program was initiated by LAT Pharma LLC (“LAT Pharma”). On April 11, 2016, BioVie acquired LAT Pharma and the rights to its BIV201 development program and currently owns all development and marketing rights to this drug candidate. Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, between predecessor entities, LAT Pharma and NanoAntibiotics, Inc. (the “LAT Pharma Agreement”), BioVie is obligated to pay a 5% royalty on the net sales of BIV201 to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc pursuant to the terms of the Royalty Agreement dated as of April 11, 2016 (the “LAT Royalty Agreement”). Pursuant to the separation agreement to be entered into between the Company and BioVie, the Company will assume the LAT Royalty Agreement, and the Company will assume the obligation to pay the 5% royalty on the net sales of BIV201 pursuant to the terms and conditions of the LAT Royalty Agreement.

Future Possible BIV201 Indications

Based on international investigative studies of the active agent in BIV201, terlipressin, we believe our drug candidate has potential future applications in other life-threatening conditions due to liver cirrhosis that are Orphan indications including HRS-AKI and bleeding esophageal varices. Orhan drugs in this therapeutic area command premium pricing with Terlivaz^® costing more than $20,000 for six days of treatment for HRS-AKI. Securing marketing approvals for any of these new uses will require well-controlled clinical trials to satisfy the FDA and/or other countries’ regulatory requirements, none of which have commenced at this time.

The Separation

We currently are, and at all times prior to completion of this offering will be, a wholly owned subsidiary of BioVie, and all of the outstanding shares of our common stock are owned by BioVie. As a result, we have never operated as a standalone company. Immediately prior to the consummation of this offering, we will issue an aggregate of 3,181,718 shares of our common stock to BioVie pursuant to the separation agreement. Upon the completion of this offering, we expect that BioVie will own approximately 64% of our outstanding common stock (or approximately 60% if the underwriters’ over-allotment option is exercised in full). As a result, BioVie will be able to exercise control over all matters requiring stockholder approval, including the election of our directors and approval of significant corporate transactions.

Prior to the completion of this offering, we will enter into various agreements with BioVie that provide for certain transactions and arrangements to effect the Separation and provide a framework for our relationship with BioVie following the Separation, including the following:

Separation Agreement — We and BioVie will enter into a separation agreement that will set forth the agreements between us and BioVie regarding the principal transactions required to effect the Separation and this offering, and other agreements governing the relationship between BioVie and us following the completion of this offering.

Management Services Agreement — We and BioVie will enter into a management services agreement that will address certain services to be performed by BioVie and certain of its executive officers and other employees to support our operations following the completion of this offering in exchange for a quarterly fee.

Registration Rights Agreement — We and BioVie will enter into a registration rights agreement, pursuant to which we will grant BioVie and its affiliates certain registration rights with respect to shares of our common stock owned by them.

Patent Assignment Agreement — We and BioVie will enter into a patent assignment agreement, pursuant to which BioVie will assign certain patents to us.

See “Certain Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation” for a more detailed discussion of the agreements described above.

All agreements relating to the Separation will be made in the context of a parent-subsidiary relationship and will be entered into in the overall context of the Separation. The terms of these agreements may be more or less favorable to us than if they had been negotiated with unaffiliated third parties. See “Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with BioVie.”

BioVie has advised us that, following the completion of this offering and subject to the expiration of any applicable lock-up periods or other agreements we have or may have with BioVie described herein, it does not have any near-term plans to distribute our shares held by it to BioVie’s stockholders. The decision to conduct any such distribution is at the sole discretion of BioVie’s board of directors. There is no assurance that such a distribution will ever occur. Presently, it is expected that any potential distribution will be taxable to BioVie and its shareholders. We refer to any such potential distribution as a “Distribution.” See “Risk Factors – Risks Related to the Separation and Our Relationship With BioVie – A Distribution may not occur and your investment in our securities may be adversely affected if BioVie does not distribute the shares of our common stock owned by BioVie.”

See “The Separation Transaction” for more information.

Corporate Information

We were incorporated as a Delaware corporation on May 1, 2025. Our principal executive offices are located at 680 W Nye Lane, Suite 201, Carson City, Nevada 89703 and our telephone number is (775) 888-1664. Our principal website address is [•]. Information contained in, or accessible through, our website is not part of, and is not incorporated into, this prospectus, and you should not rely on any such information in making an investment decision to purchase shares of our common stock.

Implications of Being a “Controlled Company”

Upon completion of this offering, BioVie will own more than a majority of the voting power of our common stock eligible to vote in the election of our directors. As a result, we will be a “controlled company” as defined under the corporate governance rules of and, therefore, will qualify for exemptions from certain corporate governance requirements of NYSE. Accordingly, we will not be required to have a majority of “independent directors,” as defined under the rules of NYSE, on the Company’s board of directors (the “Board”), and we will not be required to have a compensation committee or a nominating and corporate governance committee, in each case composed entirely of independent directors. Upon completion of this offering, the Board will not have a compensation committee, but it intends to establish a compensation committee in the future. We may take advantage of one or more other of these exemptions in the future. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE. See “Management— Controlled Company Exemption.”

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). As an emerging growth company, we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies. These include, but are not limited to:

being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;

not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditors’ report providing additional information about the audit and the financial statements;

reduced disclosure obligations regarding executive compensation; and

exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Additionally, under the JOBS Act, an emerging growth company can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. We irrevocably elected to avail ourselves of this exemption from new or revised accounting standards, and, therefore, are not subject to the same new or revised accounting standards as public companies who were not emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of June 30th of that fiscal year, (ii) the last day of the fiscal year in which we have total annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued more than $1 billion in non-convertible debt in the prior three-year period, and (iv) the last day of the fiscal year following the fifth anniversary of the date of the first sale of equity securities in our initial public offering, or December 31, 2030.

We are also a “smaller reporting company” as defined in the Exchange Act of 1934, as amended (the “Exchange Act”). We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Summary Risk Factors

Our business is subject to a number of risks which you should be aware before making an investment decision. You should carefully consider all of the information set forth in this prospectus and, in particular, should evaluate the specific factors set forth under "Risk Factors" in deciding whether to invest in our securities. These risks include but are not limited to the following:

Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements

	·	We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future. We have a high risk of never generating revenue or becoming profitable or, if we achieve profitability, we may not be able to sustain it.
	·	Even if this offering is successful, we will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.
	·	Raising additional capital may cause dilution to our stockholders, including purchasers of shares of our common stock in this offering, restrict our operations or require us to relinquish rights to our technologies or product candidates. In addition, any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.

Risks Related to Our Business and Industry

	·	We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.
	·	We have no products approved for commercial sale, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.
	·	If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.
	·	Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control. Consequently, we can provide no assurance that our product candidates will obtain regulatory approval, and if we are unsuccessful or fail to timely develop new drugs, we could be forced to discontinue our operations.
	·	We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.
	·	We will depend upon BioVie’s management, and their loss or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business, financial condition and results of operations.
	·	The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which could cause us to curtail or cease operations.
	·	There may be conflicts of interest among our officers, directors and stockholders.

Risks to Our Intellectual Property

	·	We may be unable to obtain or protect intellectual property rights relating to our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.
	·	We may not be able to protect our intellectual property rights throughout the world.
	·	We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.
	·	Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our common stock to decline.

Risks Related to the Separation and Our Relationship with BioVie

	·	We have no recent history of operating as a standalone public company, and our historical financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future.
	·	We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect our business, financial condition and results of operations.
	·	Following the completion of this offering, BioVie will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.
	·	We will be a “controlled company” within the meaning of NYSE rules and, as a result, we will qualify for, and intend to rely on, exemptions from certain corporate governance requirements.
	·	We will incur significant charges in connection with the Separation and incremental costs as a standalone public company.
	·	After this offering, our directors and executive officers may have actual or potential conflicts of interest because of their current BioVie positions or their equity ownership in BioVie.
	·	Potential indemnification obligations to BioVie in connection with the Separation could adversely affect our business, financial condition and results of operations.
	·	We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with BioVie.
	·	Following this offering, we will continue to depend on BioVie to provide us with certain services for our business.
	·	The assets and resources that we acquire from BioVie in the Separation may not be sufficient for us to operate as a stand-alone company, and we may experience difficulty in separating our assets and resources from BioVie.

Risks Related to this Offering and Ownership of Our Common Stock

	·	You will experience immediate and substantial dilution as a result of this offering.
	·	Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to the Option Therapeutics Inc. 2026 Omnibus Equity Incentive Plan (the “Plan”), could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.
	·	There is no liquid public market for our common stock and we do not know whether one will develop to provide you with adequate liquidity. If our share price fluctuates after this offering, you could lose a significant part of your investment.
	·	We have no operating experience as a public company.
	·	The market price and trading volume of our common stock may be volatile.
	·	Our common stock may experience extreme stock price volatility unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.
	·	We are an emerging growth company within the meaning of the Securities Act of 1933, as amended (the “Securities Act”) and may take advantage of certain reduced reporting requirements applicable to other public companies that are not emerging growth companies.
	·	We are considered a smaller reporting company that is exempt from certain disclosure requirements, which could make our stock less attractive to potential investors.
	·	Because we do not intend to pay any cash dividends on our common stock, our stockholders will not be able to receive a return on their shares unless they sell them.
	·	The provisions of our amended and restated certificate of incorporation will require exclusive forum in certain courts in the State of Delaware or the federal district courts of the U.S. for certain types of lawsuits may have the effect of discouraging lawsuits against our directors and officers.

The Offering

Common stock offered by us	1,818,182 shares.

Assumed public offering price	$11.00 per share (which is the midpoint of the price range set forth on the cover page of this prospectus).

Common stock outstanding immediately after giving effect to this offering	5,000,000 shares (or 5,272,727 shares if the underwriters exercise their over-allotment option to purchase additional shares in full).

Common stock to be held by BioVie immediately after giving effect to this offering	3,181,818 shares (assuming the issuance of 3,181,718 shares of our common stock to BioVie immediately prior to the consummation of this offering pursuant to the separation agreement). Upon completion of this offering, we expect that BioVie will own approximately 64% of our outstanding common stock (or approximately 60% if the underwriters exercise their over-allotment option to purchase additional shares in full).

Option to purchase additional shares	We have granted the underwriters an option to purchase up to 272,727 additional shares of our common stock. The underwriters can exercise this option at any time within 45 days from the closing of this offering solely to cover over-allotments.

Use of proceeds	We estimate the net proceeds from this offering to us will be approximately $17.0 million, or approximately $19.7 million if the underwriters exercise their over-allotment option to purchase additional shares in full, assuming an initial public offering price of $11.00 per share (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We intend to use the net proceeds from this offering for working capital and general corporate purposes that are necessary in order to operate our company, which will include, among other things, the quarterly fee for support services to be provided under the management services agreement between us and BioVie, and all of the remaining net proceeds from this offering to fund the Phase 3 clinical trial of our investigational drug candidate BIV201 (continuous infusion terlipressin). See “Use of Proceeds” for more information.

Lock-up agreements	Each of our directors and executive officers have agreed, without the prior written consent of the Representative, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of six months after the closing of this offering, subject to certain exceptions. We and any of our successors have also agreed, without the prior written consent of the Representative, among other things, not to sell, contract to sell or otherwise dispose of any securities of the Company for a period of four months after the closing of this offering, subject to certain exceptions. See “Underwriting” for more information.

Controlled Company	Upon completion of this offering, BioVie will own more than a majority of the voting power of our common stock eligible to vote in the election of our directors. As a result, we will be a “controlled company” as defined under the corporate governance rules of and, therefore, will qualify for exemptions from certain corporate governance requirements of NYSE. Accordingly, we will not be required to have a majority of “independent directors,” as defined under the rules of NYSE, on the Board, and we will not be required to have a compensation committee or a nominating and corporate governance committee, in each case composed entirely of independent directors. Upon completion of this offering, the Board will not have a compensation committee, but it intends to establish a compensation committee in the future. We may take advantage of one or more other of these exemptions in the future. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE. See “Management—Controlled Company Exemption.” As long as BioVie beneficially owns a majority of the voting power of the outstanding shares of our common stock, BioVie will generally be able to control the outcome of matters submitted to our stockholders for approval, including the election of directors, without the approval of our other stockholders. See “Risk Factors—Risks Related to the Separation and Our Relationship with BioVie—Following the completion of this offering, BioVie will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.”

Risk factors	Investing in our common stock involves a high degree of risk. See the section titled “Risk Factors” and other information included in this prospectus for a discussion of factors you should consider before investing in our common stock.

Proposed listing	We intend to apply to list to list our common stock on NYSE under the symbol “OPTN”.

Unless otherwise indicated, the information presented in this prospectus:

	·	gives effect to the transactions described under “The Separation Transaction”;
	·	gives effect to our amended and restated certificate of incorporation and our amended and restated bylaws, which will be in effect prior to the completion of this offering and forms of which have been filed as exhibits to the registration statement of which this prospectus is a part;
	·	assumes the issuance of an aggregate of 3,181,718 shares of our common stock to BioVie immediately prior to the consummation of this offering pursuant to the separation agreement;
	·	assumes no exercise of the Representative’s Warrants (as defined herein) to purchase additional shares of our common stock;
	·	assumes no exercise of the underwriters’ over-allotment option to purchase additional shares; and
	·	excludes shares of our common stock that we expect to reserve for issuance under the 2026 Plan.

Summary Historical Financial Information

The following table sets forth our summary historical financial information. You should read the summary historical financial information in conjunction with “Management's Discussion and Analysis of Financial Condition and Results of Operations,” our audited carve-out financial statements, our unaudited condensed carve-out financial statements and related notes thereto. We have derived the summary historical financial information as of and for the years ended June 30, 2025 and 2024 from our audited carve-out financial statements and as of December 31, 2025 and for the six months ended December 31, 2025 and 2024 from our unaudited condensed carve-out financial statements included elsewhere in this prospectus.

Our historical carve-out financial statements may not be reflective of our financial position, results of operations and cash flows had we operated as a stand-alone public company during all periods presented. Our historical carve-out financial statements have been prepared on a “carve-out” basis from the financial statements of BioVie to represent our financial position and performance as if we had existed on a stand-alone basis during such all periods presented. Our historical carve-out financial statements were prepared on a standalone basis in accordance with GAAP.

Our historical carve-out financial statements include the assets, liabilities, and operating expenses based on our legal entity structure as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are partially provided on a centralized basis by BioVie, which include finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance and other professional services. Indirect costs have been allocated to us for the purposes of preparing the carve-out financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on headcount or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or benefit received by us during the periods presented, depending on the nature of the services received.

	Year Ended June 30, (audited)						Six Months Ended December 31, (unaudited)
Carve-Out Statements of Operations:	2025			2024			2025			2024
Operating expenses	$	1,223,839		$	1,939,727		$	451,322		$	398,845
Net loss	$	(1,223,839	)	$	(1,939,727	)	$	(451,322	)	$	(398,845	)
Pro forma net loss per share, basic and diluted (unaudited)⁽¹⁾	$	(0.24)		$	(0.39)		$	(0.09)		$	(0.08)
Weighted-average number of shares of common stock outstanding used in computing pro forma net loss per share, basic and diluted (unaudited)⁽¹⁾		5,000,000			5,000,000			5,000,000			5,000,000

(1)

The weighted-average number of shares used to compute pro forma net loss per share, basic and diluted (unaudited) represents the number of shares of our common stock expected to be outstanding immediately following the completion of this offering (assuming no exercise of the underwriters’ over-allotment option to purchase additional shares). The calculation includes shares expected to be sold in this offering and shares expected to be issued to BioVie as part of the Separation.

	Year Ended June 30, (audited)						Six Months Ended December 31, (unaudited)
Carve-Out Statements of Cash Flows:	2025			2024			2025			2024
Net cash used in operating activities	$	(1,157,224	)	$	(1,866,823	)	$	(712,419	)	$	(202,843	)
Net cash flows provided by financing activities	$	1,157,224			1,866,823		$	712,419		$	202,843

	As of June 30, (audited)				As of December 31, 2025 (unaudited)
Carve-Out Balance Sheet:	2025		2024		Actual		As adjusted⁽¹⁾
Cash	$	-	$	-	$	-	$	16,996,220
Other current assets	$	493,075	$	62,810	$	796,870	$	796,870
Total assets	$	1,017,127	$	816,239	$	1,206,234	$	18,202,454
Total liabilities	$	127,217	$	12,845	$	10,531	$	10,531
Total parent’s net investment/stockholder’s equity	$	889,910	$	803,394	$	1,195,703	$	18,191,923

(1)

The as adjusted column gives effect to the issuance and sale by us in this offering of 1,818,182 of our common stock at the assumed public offering price of $11.00 per share, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and assuming the over-allotment option to purchase additional shares is not exercised by the underwriters.

RISK FACTORS

You should carefully consider the risks described below and all other information contained in this prospectus before making an investment decision. If any of the following risks actually occur, individually or in the aggregate, they could have a material adverse effect on our business, financial condition and results of operations. In that event, the trading price of our securities could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including, but not limited to, the risks described below and elsewhere in this prospectus. See “Forward- Looking Statements.”

Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements

We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future. We have a high risk of never generating revenue or becoming profitable or, if we achieve profitability, we may not be able to sustain it.

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We are a clinical-stage biopharmaceutical company with a relatively limited operating history upon which you can evaluate our business and prospects. We were incorporated in May 2025 and have not generated revenue. Therefore, there is limited historical financial or operational information upon which to evaluate our performance. Our prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Many if not most companies in our industry at our stage of development never become profitable and are acquired or go out of business before successfully developing any product that generates revenue from commercial sales or enables profitability.

We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future as we continue the clinical development of, seek regulatory approval for and potentially commercialize BIV201 and any future product candidates, as well as operate as a public company. The amount of future losses and when, if ever, we will become profitable are uncertain. We do not have any products that have generated any revenues from commercial sales and do not expect to generate revenues from the commercial sale of products in the near future, if ever. If we are unable to successfully develop, obtain requisite approval for and commercialize BIV201 or any future product candidates, we may never generate revenue. Our ability to generate revenue and achieve profitability will depend on, among other things, successful completion of the development of our product candidates; obtaining necessary regulatory approvals from the FDA and international regulatory agencies; establishing manufacturing, sales, and marketing arrangements with third parties; obtaining adequate reimbursement by third-party payers; and raising sufficient funds to finance our activities. If we are unsuccessful at some or all of these undertakings, they could have a material adverse effect on our business, financial condition, and results of operations.

To become and remain profitable, we must succeed in developing, obtaining regulatory approvals for, and eventually commercializing products that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing human clinical trials of BIV201 and any future product candidates, acquiring or developing additional product candidates, obtaining regulatory approval for BIV201 and any future product candidates, and manufacturing, marketing, and selling any products for which we may obtain regulatory approval. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate revenue that is significant enough to achieve profitability. In addition, we have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the biopharmaceutical industry. Because of the numerous risks and uncertainties associated with biopharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable may have an adverse effect on the value of our company and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product candidates, achieve our strategic objectives or even continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.

Even if this offering is successful, we will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our development programs, commercialization efforts, or other operations.

The development of biopharmaceutical product candidates, including conducting preclinical studies and clinical trials, is a very time-consuming, capital-intensive and uncertain process. Our operations have consumed substantial amounts of cash since inception. We expect our expenses to substantially increase in connection with our ongoing activities, particularly as we conduct our ongoing and planned clinical trials of BIV201 and potentially seek regulatory approval for BIV201 and any future product candidates we may develop. In addition, if we are able to progress BIV201 through development and commercialization, we expect to be required to make milestone or royalty payments pursuant to various license or collaboration agreements with third parties. If we obtain regulatory approval for BIV201 or any future product candidates, we also expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution. Because the outcome of any clinical trial or preclinical study is highly uncertain, we cannot reliably estimate the actual amount of capital necessary to successfully complete the development and commercialization of BIV201 or any future product candidates. Furthermore, following the completion of this offering, we expect to incur additional costs associated with operating as a public company.

The amount of net proceeds from this offering may not be sufficient to fund BIV201 through our Phase 3 trial, and additional capital resources may be required to fund BIV201 through such Phase 3 trial. We will also need to raise substantial additional funds to commercialize BIV201, if approved. We may satisfy our future cash needs through the sale of equity securities, debt financings, working capital lines of credit, corporate collaborations or license agreements, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources. The amount and timing of our actual expenditures will depend on numerous factors, including the status and results of our clinical trials, success of our research and development efforts, the FDA process, the amounts of proceeds actually raised in this offering and the amount of cash generated by our operations.

Our ability to raise additional funds may be adversely impacted by global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, or even cease operations. We expect to finance our cash needs through public or private equity or debt financings or other capital sources, including potential collaborations, licenses, and other similar arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Attempting to secure additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to develop BIV201 or any future product candidates.

Our future capital requirements will depend on many factors, including without limitation:

the initiation, type, number, scope, progress, expansions, results, costs, and timing of clinical trials and preclinical studies of BIV201 and any future product candidates we may choose to pursue, including the costs of modification to clinical development plans (including an increase in the number, size, duration and/or complexity of a trial) based on feedback that we may receive from regulatory authorities and any third-party products used as combination agents in our clinical trials;

the costs and timing of manufacturing for BIV201 or any future product candidate, including commercial manufacturing at sufficient scale and encountering higher than expected costs to manufacture our current and future active pharmaceutical ingredients, if any product candidate is approved, including as a result of inflation, any supply chain issues or component shortages;

slower than expected progress in developing BIV201 or a future product candidate, including without limitation, additional costs caused by such program delays;

the costs, timing and outcome of regulatory meetings and reviews of BIV201 and developing certain formulations of BIV201 or any future product candidates in any jurisdictions in which we or our current or any future collaborators may seek approval for BIV201 or any future product candidates;

our efforts to enhance operational systems and hire additional personnel to satisfy our obligations as a public company, including enhanced internal control over financial reporting;

the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and potential future license or collaboration agreements with third parties;

the costs and timing of establishing or securing sales and marketing capabilities and commercial compliance programs if BIV201 or any future product candidate is approved;

higher than expected personnel, consulting or other costs, such as adding personnel or industry expert consultants or pursuing the licensing/acquisition of additional assets;

higher than expected costs to obtain, maintain, enforce and protect our patents and other intellectual property and proprietary rights;

our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products;

our ability and strategic decision to develop future product candidates other than BIV201, and the timing of such development, if any;

patient willingness to pay out-of-pocket for any approved products in the absence of coverage and/or adequate reimbursement from third-party payors;

the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and

our ability to raise sufficient funds when and if required.

Conducting clinical trials and preclinical studies and potentially identifying future product candidates is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and commercialize BIV201 or any future product candidates. If approved, BIV201 and any future product candidates may not achieve commercial success. We expect that our commercial revenue, if any, will initially be derived from sales of BIV201, which we do not expect to be commercially available for several years, if at all. Commercial success in the United States may depend upon acceptance and coverage by federal healthcare program and third-party payors, and it can be time consuming and costly to demonstrate that any of our products should be covered.

Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability, market-wide liquidity shortages, geopolitical events, or otherwise.

Raising additional capital may cause dilution to our stockholders, including purchasers of our common stock in this offering, restrict our operations or require us to relinquish rights to our technologies or product candidates. In addition, any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including potential collaborations, licenses, and other similar arrangements. We do not have any committed external source of funds. If we attempt to raise additional financing, there can be no assurance that we will be able to secure such additional financing in sufficient quantities or at all. We may be unable to raise additional capital for reasons including, without limitation, our operational and/or financial performance, investor confidence in us and the biopharmaceutical industry, credit availability from banks and other financial institutions, the status of current projects, and our prospects for obtaining any necessary regulatory approvals. Potential investors’ capital investments may have shifted to other opportunities with perceived greater returns and/or lower risk thereby reducing capital available to us, if available at all.

In addition, any additional financing might not be available, and even if available, may not be available on terms favorable to us or our then-existing investors. We may seek to raise funds through public or private equity offerings, debt financings, corporate collaboration or licensing arrangements, mergers, acquisitions, sales of intellectual property, or other financing vehicles or arrangements. To the extent that we raise additional capital by issuing equity securities or other securities (including convertible debt), our then-existing investors will experience dilution, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a stockholder. If we raise funds through debt financings or bank loans, we may become subject to restrictive covenants, such as incurring additional debt, making capital expenditures or declaring dividends. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. Moreover, if we raise funds through debt financings or bank loans, our assets may be pledged as collateral for the debt, and the interests of our then-existing investors would be subordinated to the debt holders or banks. In addition, our use of and ability to exploit assets pledged as collateral for debt or loans may be restricted or forfeited. To the extent that we raise additional funds through collaboration or licensing arrangements, we may be required to relinquish valuable rights to our future revenue streams, product candidates, research programs, intellectual property or proprietary technology, or grant licenses on terms that are not favorable to us and/or that may reduce the value of our common stock. If we are not able to raise needed funding when needed under acceptable terms or at all, then we would be required to delay, limit, reduce, curtail, abandon or terminate our product development or future commercialization efforts, or grant rights to develop and market product candidates that we might otherwise prefer to develop and market ourselves, or on less favorable terms than we would otherwise choose, or sell assets, or cease operations entirely.

Risks Related to Our Business and Industry

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

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

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

Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons. Pre-clinical study results may show the product candidate to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects. Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies; length of time to achieve study endpoints; additional time requirements for data analysis; IND and later new drug application preparation; discussions with the FDA; an FDA request for additional pre-clinical or clinical data; unexpected safety or manufacturing issues; manufacturing costs; pricing or reimbursement issues; clinical sites deviating from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements - which can render data from those sites unusable in support of regulatory approval; or other factors that make the product not economical. Proprietary rights of others and their competing products and technologies may also prevent the product from being commercialized.

Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next and may be difficult to predict. There can be no assurance that any of our products will develop successfully, and the failure to develop our products could have a material adverse effect on our business, financial condition and results of operations, which could cause you to lose all of your investment.

In the future, we may be subject to litigation, all of which may require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, which could have a material adverse effect on our business, financial condition and results of operations and negatively affect the price of our common stock.

BioVie is currently subject to securities class action litigation, which is described in Note 8 to our audited carve-out financial statements as of and for the years ended June 30, 2025 and 2024 and our unaudited condensed carve-out financial statements as of the six months ended December 31, 2025 and for the six months ended December 31, 2025 and 2024 included elsewhere in this prospectus. Upon consummation of the Separation, such securities class action litigation will remain BioVie’s liability and we will be indemnified pursuant to the separation agreement. We are not otherwise currently subject to any legal proceedings or claims. In the future, we may become subject to various legal proceedings and claims that arise in or outside our ordinary course of business. It is possible that lawsuits will be filed, or allegations received from stockholders, with respect to matters related to our business and also naming us and/or our officers and directors as defendants. Such lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of such lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of any such lawsuits, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with such lawsuits. Monitoring, initiating and defending against legal actions is time-consuming for our management, is likely to be expensive and may detract from our ability to fully focus our internal resources on our business activities. We could be forced to expend significant resources in the settlement or defense of any potential future lawsuits, and we may not prevail in such lawsuits.

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 claim. A decision adverse to our interests in any lawsuit could result in the payment of substantial damages, or possibly fines, and could have a material adverse effect on our business, financial condition and results of operations. We have not established any reserve for any potential liability relating to any potential future lawsuits. Any such payments or settlement arrangements in future litigation could have a material adverse effect on our business, financial condition and results of operation. 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, have never generated any revenues and may never achieve revenues or profitability, which could cause us to cease operations.

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, our product candidate, is 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 candidate; and (d) market acceptance of our product. There are no assurances that we will achieve any of the forgoing objectives. Furthermore, our product candidate is in the development stage and has not been fully evaluated in human clinical trials. If we do not successfully develop and commercialize our product candidate, 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.

We are a development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.

We are a development stage biopharmaceutical company with a potential therapy that has 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.

Since inception, we have not established any revenues or operations that would provide financial stability in the long term, and there can be no assurance that we will realize our plans on our projected timetable in order to reach sustainable or profitable operations.

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 prospectus do not include any adjustments that might result from the outcome of this uncertainty.

Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our Company. Our ability to become profitable depends primarily on our ability to develop drugs, to obtain approval for such drugs, and if approved, to successfully commercialize our drugs, our research and development (“R&D”) efforts, including the timing and cost of clinical trials; and our ability to enter into favorable alliances with third-parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.

Even if we successfully develop and market BIV201, we may not generate sufficient or sustainable revenue to achieve or sustain profitability, which could cause us to cease operations and cause you to lose all of your investment.

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

Once a new drug application (“NDA”) is approved, the product covered thereby becomes a “reference listed drug” (“RLD”), in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. 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. BIV201 does not qualify for NCE because FDA approved an NDA in 2022 that contained a powdered form of terlipressin as the active ingredient. In cases where a five-year NCE 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 seven and a half years after the NDA approval if the generic application was filed between four years and five 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.

Competition that our products may face from generic versions of our products could have a material adverse effect on our business, financial condition, and results of operations and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity, and on our intellectual property rights, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.

We have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites (due to all etiologies except cancer) on September 8, 2016. 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 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, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues. 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.

Our current Phase 3 clinical trial protocol for BIV201 targets adult patients with decompensated liver cirrhosis and ascites who have recently recovered from, or are recovering from, an episode of AKI. The trial is designed to demonstrate potential clinical benefit through a composite primary endpoint consisting of complications and disease progression. Under FDA regulations, orphan drug designation is tied to a drug for a rare disease or condition rather than to a particular study design or endpoint. Because the protocol requires all patients in the study to have ascites due to non-malignant etiologies, we believe the planned Phase 3 trial falls within the scope of BIV201’s existing orphan drug designation for the treatment of ascites due to all etiologies except cancer. We intend to continue development under that designation and to engage with the FDA, as appropriate, to confirm alignment as our program advances. If the FDA determines that the clinical trial endpoints or patient population do not fall within the scope of the orphan drug designation, we may not be entitled to orphan drug exclusivity for BIV201 even if the trial is successful and marketing approval is obtained. This could materially and adversely affect our competitive position and our ability to generate revenues from BIV201.

Even though BioVie has obtained two Orphan Drug Designations for its lead product candidate, BIV201 (terlipressin), for treatment of ascites and for treatment of hepatorenal syndrome, and may seek other Orphan Drug Designations for BIV201, there is no assurance that we will be the first to obtain marketing approval for any particular rare indication or be able to demonstrate clinical superiority. In 2004, Mallinckrodt Hospital Products IP Limited received Orphan Drug designation for its product candidate, Terlivaz^® for injection for the treatment of hepatorenal syndrome. In September 2022, FDA approved the product to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. As the first FDA-approved medication for hepatorenal syndrome, Mallinckrodt’s product was granted a seven-year period of marketing exclusivity. Consequently, FDA may not be able to approve an application for BIV201 (terlipressin) for hepatorenal syndrome unless we generate evidence of BIV201 being clinical superior to Terlivaz^® by means of greater effectiveness, greater safety, or providing a major contribution to patient care.

Even though we have obtained Orphan Drug Designations for our lead product candidate, or even if we obtain Orphan Drug Designation for other potential product candidates, such designation may not effectively protect us 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, as noted above, 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 for indications other than hepatorenal syndrome. 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 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.

We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms, which could have a material adverse effect on our business, financial condition and results of operations.

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 development 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.

The amount and timing of our actual expenditures will depend on numerous factors, including the status and results of our clinical trials, success of our research and development efforts, the FDA process, the amounts of proceeds actually raised in this offering and the amount of cash generated by our operations. Our management will have broad discretion to allocate the net proceeds from this offering.

In addition, we may not have the resources to complete the development and commercialization of any future product candidates. We will require additional financing to further the clinical development of any future product candidates. This will delay or require termination of research and development programs, preclinical studies and clinical trials, material characterization studies, regulatory processes, the establishment of our own laboratory or a search for third party marketing partners to market our products for us, which could have a material adverse effect on our business, financial condition and results of operations.

The amount of capital we may need will depend on many factors, including the progress, timing and scope of our research and development programs, the progress, timing and scope of our preclinical studies and clinical trials, the time and cost necessary to obtain regulatory approvals, the time and cost necessary to establish our own marketing capabilities or to seek marketing partners, the time and cost necessary to respond to technological and market developments, changes made or new developments in our existing collaborative, licensing and other commercial relationships, and new collaborative, licensing and other commercial relationships that we may establish.

Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through the sale of equity securities, debt financings, working capital, lines of credit, corporate collaborations or license agreements, grant funding, interest income earned on invested cash balances or a combination of one or more of these sources. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts. In addition, we could be forced to discontinue product development and reduce or forego attractive business opportunities. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.

Our fixed expenses, such as rent and other contractual commitments, will likely increase in the future, as we may enter into leases for new facilities and capital equipment and/or enter into additional licenses and collaborative agreements. Therefore, if we fail to raise substantial additional capital to fund these expenses, we could be forced to cease operations, which could cause you to lose all of your investment.

We have limited experience in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations.

We have never successfully developed a new drug and brought it to market. Our management and clinical teams have experience in drug development, but they may not be able to successfully develop any drugs. Our ability to achieve revenues and profitability in our business will depend on, among other things, our ability to develop products internally or to obtain rights to them from others on favorable terms; complete laboratory testing and human studies; obtain and maintain necessary intellectual property rights to our products; successfully complete regulatory review to obtain requisite governmental agency approvals; enter into arrangements with third parties to manufacture our products on our behalf; and enter into arrangements with third parties to provide sales and marketing functions. If we are unable to achieve these objectives, we will be forced to cease operations and you will lose all of your investment.

Development of pharmaceutical products is a time-consuming process, subject to a number of risks, many of which are outside of our control. Consequently, we can provide no assurance that our product candidates will obtain regulatory approval, and if we are unsuccessful or fail to timely develop new drugs, we could be forced to discontinue our operations.

Development and extensive testing will be required to determine the technical feasibility and commercial viability of BIV201. 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, 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 the current standard of care resulted in a reduction in ascites fluid accumulation during treatment versus pre-treatment. In June 2023, BioVie requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. Over three years since the initial enrollment of this clinical trial, BioVie is continuing to finalize protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

Any delay or further delay in the development, introduction or marketing of our product candidates could result either in such drugs being marketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term nature of our projects and other risk factors described elsewhere in this document, we may not be able to successfully complete the development or marketing of any drugs, which could cause us to cease operations.

From time to time, the FDA may have feedback on our clinical trial designs, including for example certain of our endpoints and outcome measures. As a result, we may consider revisions to our protocols which may delay progress in implementing our trials. We may fail to successfully develop and commercialize our product candidate(s) if it is found to be unsafe or ineffective in clinical trials; does not receive necessary approval from the FDA or foreign regulatory agencies; fails to conform to a changing standard of care for the disease it seeks to treat; or is less effective or more expensive than current or alternative treatment methods.

Drug development failure can occur at any stage of clinical trials and as a result of many factors, there can be no assurance that we or our collaborators will reach our anticipated clinical targets. Even if the trials are successfully completed, clinical data are often susceptible to varying interpretations and analyses, and we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. We cannot guarantee that the FDA or comparable foreign regulatory authorities will view our product candidates as having efficacy even if positive results are observed in clinical trials. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols, and the rate of dropout among clinical trial participants. If the results of our ongoing or future clinical trials are inconclusive with respect to the efficacy of our product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates, we may be delayed in obtaining marketing approval, if at all. Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory approval of our product candidates in those and other indications. We also do not know what the long-term effects of exposure to our product candidates will be. Furthermore, our product candidates may be used in combination with other treatments and there can be no assurance that such use will not lead to unique or unexpected safety issues.

Failure to complete clinical trials or to prove that our product candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations, which could cause you to lose all of your investment.

We may expend our limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

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 development 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 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. 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 no manufacturing experience, and the failure to comply with all applicable manufacturing regulations and requirements could have a material adverse effect on our business, financial condition and results of operations.

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 to perform the manufacturing of BIV201. In addition, we do not have the resources at this time to acquire or lease suitable facilities. If we or our contract manufacturing organization 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.

In addition, the FDA and other regulatory authorities require that product candidates and drug products be manufactured according to the FDA’s current Good Manufacturing Practices regulations (“cGMP”). Any failure by our third-party manufacturers to comply with cGMP could lead to a shortage of BIV201. In addition, such failure could be the basis for action by the FDA to withdraw approval, if granted to us, and for other regulatory enforcement action, including Warning Letters, product seizure, injunction or other civil or criminal penalties.

BIV201 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, we may not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonably 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 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.

If our existing third-party manufacturers, or the third parties that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to continue to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers. If for any reason we are unable to obtain adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used to manufacture it, it will be more difficult for us to compete effectively, generate revenue, and further develop our products. In addition, if we are unable to assure a sufficient quantity of the drug for patients with rare diseases or conditions, we may lose any Orphan Drug exclusivity to which the product otherwise would be entitled.

We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a material adverse effect on our business, financial condition and results of operations.

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. If we fail to hire and retain the requisite expertise in order to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing staff, then we could be forced to cease operations, and you could lose all of your investment.

Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations, which could have a material adverse effect on our business, financial condition and results of operations.

If we were to successfully develop approvable drugs, before we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and process or the manufacturing facility and process of the third party or parties with whom we may outsource our manufacturing activities. In addition, the manufacture of our products must comply with the FDA’s cGMPs. The cGMP regulations govern quality control and documentation policies and procedures. Our manufacturing facilities, if any in the future, and the manufacturing facilities of our third-party manufacturers will be continually subject to inspection by the FDA and other state, local and foreign regulatory authorities, before and after product approval. We cannot guarantee that we, or any potential third-party manufacturer of our products, will be able to comply with the cGMP regulations or other applicable manufacturing regulations. The failure to comply with all necessary regulations could have a material adverse effect on our business, financial condition and results of operations and could force us to cease operations and you could lose all of your investment.

We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.

The R&D, manufacture and marketing of drug product candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries. These national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including testing in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and promotion of the product that we are developing. Noncompliance with applicable requirements can result in various adverse consequences, including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations, revocation of approvals previously granted, warning letters, fines, criminal prosecution, recalls or seizures of products, injunctions against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts.

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 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 material adverse effect on our business, financial condition and results of operations.

The FDA, clinical investigators, Data Safety Monitoring Boards, and IRBs review the ongoing conduct of, and emerging safety information from, clinical trials and may order the temporary or permanent discontinuation of clinical trials at any time if it believes the product candidate exposes clinical subjects to an unacceptable health risk. Investigational drugs used in clinical studies must be produced in compliance with cGMP rules pursuant to FDA regulations.

Development, approval, and sales outside the United States of products that we develop will also be subject to regulatory requirements governing human clinical trials and marketing for drugs and biological products and devices. The requirements vary widely from country to country, but typically the registration and approval process takes several years and requires significant resources.

If we experience delays or discontinuations of our clinical trials by the FDA or comparable authorities in other countries, or if we fail to obtain registration or other approvals of our products or devices then we could be forced to cease our operations and you will lose all of your investment.

Even if we are successful in developing BIV201, our product candidate, we have limited experience in conducting or supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA. In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be approved for sale which could have a material adverse effect on our business, financial condition and results of operations.

We will depend upon BioVie’s management, and their loss or unavailability could put us at a competitive disadvantage which could have a material adverse effect on our business, financial condition and results of operations.

Pursuant to the terms of the management services agreement, BioVie will provide us with the services of certain of its executive officers and other employees to support our operations following the completion of this offering in exchange for a quarterly fee. All salaries and compensation to such persons will be paid by BioVie. The executive officers of BioVie will also serve as our executive officers. We will have no other employees directly employed by us prior to the consummation of this offering, but we may have employees in the future. As a result, we will initially depend upon the efforts and abilities of BioVie’s executive officers and other employees. 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, 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.

We may not be able to attract and retain highly skilled personnel, which could have a material adverse effect on our business, financial condition and results of operations.

Our ability to attract and retain highly skilled personnel is critical to our operations and expansion. We face competition for these types of personnel from other pharmaceutical companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than us. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all. If we are not successful in attracting and retaining these personnel, this could cause a material adverse effect on our business, financial condition and results of operations.

The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us, which could cause us to curtail or cease operations.

The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors. These factors include 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.

We compete 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. Many biopharmaceutical companies have focused their development efforts in the human therapeutics area. Many major pharmaceutical companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. These companies, as well as academic institutions, government agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to us.

Although there are not currently any drug 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 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. Sequahana Medical, for instance, announced in December 2024 that FDA had approved the company’s active implantable medical device (Class III) for the treatment of recurrent or refractory ascites due to liver cirrhosis. There may be other competitive development programs of which we are unaware. Even if our product candidate is ultimately approved by the FDA, there is no guarantee that once it is on the market doctors will adopt them in favor of current ascites treatment procedures such as diuretics and paracentesis with respect to BIV201. These competitive and market risks could have a material adverse effect on our business, financial condition and results of operations which may cause you to lose all of your investment.

Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market introduction of some of our potential product candidate or of competitors’ products may be an important competitive factor. Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial quantities to market are important competitive factors. We expect that competition among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.

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

There may be conflicts of interest among our officers, directors and stockholders.

Certain of our executive officers and directors and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons. Neither we nor any of our stockholders will have any rights in these ventures or their income or profits. In particular, our executive officers or directors or their affiliates may have an economic interest in or other business relationship with partner companies that invest in us or are engaged in competing drug development. Our executive officers or directors may have conflicting fiduciary duties to us and third parties. The terms of transactions with third parties may not be subject to arm’s length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations. Although we have established an audit committee comprised solely of independent directors to oversee transactions between us and our insiders, we do not have any formal policies in place to deal with such conflicting fiduciary duties should such a conflict arise.

We indemnify our officers and directors against liability to us and our security holders, and such indemnification could increase our operating costs.

Our amended and restated certificate of incorporation and our amended and restated bylaws will require us to indemnify our officers and directors against claims associated with carrying out the duties of their offices. We will also be 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, may be permitted to our officers, directors, or control persons, the SEC has advised that such indemnification is against public policy and is therefore unenforceable.

Risks Related to Our Intellectual Property

We may be unable to obtain or protect intellectual property rights relating to our product candidates, which could have a material adverse effect on our business, financial condition and results of operations.

Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies. We cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents with respect to the technology owned by us or licensed to us. Further, we cannot predict how long it will take for such patents to issue, if at all. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or circumvented.

We have six granted and seven pending patent applications for our liquid formulations of BIV201 that claim priority to PCT/US2020/034269 filed on May 22, 2020 and published as WO2020/237170. 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 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 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 development 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.

We currently are the assignee of a number of U.S. provisional patent applications. U.S. provisional patent applications are not eligible to become issued patents until, among other things, we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent applications. With regard to such U.S. provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional patent applications. Further, in the event that we do timely file non-provisional patent applications relating to our provisional patent applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such issued patents will provide us with any competitive advantage.

As to our material inventions, trade secrets, and intellectual property, our employees, consultants, and advisors execute confidentiality agreements and agree to disclose and assign to us all inventions conceived during the workday, using our property, or which relate to our business. However, any of these parties may breach these agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug candidates. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions.

The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the subject of much debate and litigation throughout the world. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. The standards that the United States Patent and Trademark Office (the “USPTO”) (and foreign countries) use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. The issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. The subject matter claimed in a patent application can be significantly reduced or eliminated before the patent issues, if at all, and its scope can be reinterpreted or narrowed after issuance. Therefore, our pending and future patent applications may not result in patents being issued in relevant jurisdictions that protect our drug candidates, in whole or in part, or that effectively prevent others from commercializing competitive drug candidates, and even if our patent applications issue as patents in relevant jurisdictions, they may not issue in a form that will provide us with any meaningful protection for our drug candidates or technology, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Additionally, our competitors may be able to circumvent our patents by challenging their validity or by developing similar or alternative drug candidates or technologies in a non-infringing manner.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention or other features of patentability. An adverse determination in any such submission, proceeding or litigation could result in loss of exclusivity or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated or held unenforceable, in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all of which could limit our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete directly with us, without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products (if any) without infringing third-party patent rights. In addition, if the breadth or strength of the claims of our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research programs or clinical trials. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us.

In addition, given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all. Moreover, some of our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties. If we are unable to obtain exclusive licenses to any such co-owners’ interest in such patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In addition, we may need the cooperation of any such co-owners in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could harm our competitive position, business, financial condition, results of operations and prospects.

Further, we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, there could be a material adverse effect on our business, financial condition and results of operations. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in protecting our proprietary rights in these countries.

Our success depends in significant part on our ability to obtain, maintain, enforce and defend patents and other intellectual property rights with respect to our drug candidates and technology and to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights of others. If we are unable to obtain and maintain sufficient intellectual property protection for our drug candidates or other drug candidates that we may identify, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors and other third parties could develop and commercialize drug candidates similar or identical to ours, and our ability to successfully commercialize our drug candidates and other drug candidates that we may pursue may be impaired.

Confidentiality agreements may not adequately prevent disclosure of trade secrets and other proprietary information and disclosure of our trade secrets or proprietary information could compromise any competitive advantage that we have, which could have a material adverse effect on our business, financial condition and results of operations.

Our success will depend, in part, on our ability to protect our proprietary rights to the technologies used in our product candidates. We will depend heavily upon confidentiality agreements with BioVie’s executive officers and other employees, our executive officers and any other future employees, consultants and subcontractors to maintain the proprietary nature of our technology. These measures may not afford us complete or even sufficient protection and may not afford an adequate remedy in the event of an unauthorized disclosure of confidential information. If we fail to protect and/or maintain our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, and/or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property. In addition, others may independently develop technology similar to ours, otherwise avoiding the confidentiality agreements, or produce patents, which could have a material adverse effect on our business, financial condition and results of operations, in which event you could lose all of your investment.

We may enter into licensing and collaboration agreements with third parties. If we fail to comply with our obligations in the agreements under which we license intellectual property rights to or from third parties, or these agreements are terminated, or we otherwise experience disruptions to our business relationships with our licensors or licensees, our competitive position, business, financial condition, results of operations and prospects could be harmed.

It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our products (if approved), in which case we would be required to obtain a license from these third parties. The licensing of third-party intellectual property rights is a competitive area, and more established companies may pursue strategies to license or acquire third-party intellectual property rights that we may consider attractive or necessary. More established companies may have a competitive advantage over us due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment or at all. If we are unable to license such technology, or if we are forced to license such technology on unfavorable terms, there could be a material adverse effect on our business, financial condition and results of operations.

We may fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. Licenses may not provide us with exclusive rights to use the applicable intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our drug candidates, products (if approved) and technology in the future. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could have a material adverse effect on our business, financial condition and results of operations, and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors, and we may not be able to prevent competitors from developing and commercializing competitive products or technologies.

In addition, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications or to maintain, defend and enforce the patents that we license to or from third parties, and we may have to rely on our partners to fulfill these responsibilities. If our current or future licensors, licensees or collaborators fail to prepare, file, prosecute, maintain, enforce, and defend licensed patents and other intellectual property rights, such rights may be reduced or eliminated, and our right to develop and commercialize any of our drug candidates or technology that are the subject of such licensed rights could be adversely affected. In addition, our licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights.

If we fail to comply with our obligations, including the obligation to make various milestone payments and royalty payments, under any of the agreements under which we license intellectual property rights from third parties, the licensor may have the right to terminate the license. If any of our license agreements is terminated, the underlying licensed patents fail to provide the intended exclusivity or we otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business or be prevented from developing and commercializing our drug candidates, and competitors could have the freedom to seek regulatory approval of, and to market, products identical to ours. Termination of these agreements or reduction or elimination of our rights under these agreements may also result in our having to negotiate new or reinstated agreements with less favorable terms, cause us to lose our rights under these agreements, including our rights to important intellectual property or technology, or impede, delay or prohibit the further development or commercialization of one or more drug candidates that rely on such agreements. It is possible that we may be unable to obtain any additional licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be required to expend significant time and resources to redesign our drug candidates or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis.

Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues and certain provisions in intellectual property license agreements may be susceptible to multiple interpretations. Disputes may arise between us and our licensing partners regarding intellectual property subject to a license agreement, including:

the scope of rights granted under the license agreement and other interpretation-related issues;

whether and the extent to which technology and processes of one party infringe intellectual property of the other party that are not subject to the licensing agreement;

rights to sublicense patent and other rights to third parties;

any diligence obligations with respect to the use of the licensed technology in relation to development and commercialization of our drug candidates, and what activities satisfy those diligence obligations;

the ownership of inventions and know-how resulting from the joint creation or use of intellectual property;

rights to transfer or assign the license; and

the effects of termination.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could harm our business, financial condition, results of operations and prospects. If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms or at all, we may be unable to successfully develop and commercialize the affected drug candidates. Moreover, any dispute or disagreement with our licensing partners may result in the delay or termination of the research, development or commercialization of our drug candidates or any future drug candidates, and may result in costly litigation or arbitration that diverts management attention and resources away from our day-to-day activities, which may adversely affect our business, financial condition, results of operations and prospects.

Furthermore, current and future collaborators or strategic partners may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by our collaborators or strategic partners or to which the collaborators or strategic partners have rights, may result in the withdrawal of partner support for our drug candidates. Any of these developments could harm our product development efforts.

In addition, if our licensors fail to abide by the terms of the license, if the licensors fail to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable there could be a material adverse effect on our business, financial condition and results of operations.

Some of our intellectual property may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies if it is determined that our intellectual property has been discovered through government-funded programs. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

Some of the intellectual property rights we have acquired or licensed or may acquire or license in the future may have been generated through the use of U.S. government funding and may therefore be subject to certain federal regulations. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products relating to such intellectual property. To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from competitive medications, including generic versions. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S. patents may be eligible for limited patent term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries. The Hatch-Waxman Act permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request. Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing products sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier than might otherwise be the case, which could have a material adverse effect on our business, financial condition and results of operations.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, maintaining, defending and enforcing patents on our drug candidates in all countries throughout the world would be prohibitively expensive, and consequently our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and may export otherwise infringing products to territories where we have patents, but enforcement rights are not as strong as those in the United States. These products may compete with our drug candidates and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries do not favor the enforcement or protection of patents, trade secrets and other intellectual property, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our intellectual property and proprietary rights generally. Proceedings to enforce our intellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

Many foreign countries, including some EU countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of the applicable patents and limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license, which could adversely affect our business, financial condition, results of operations and prospects.

In 2012, the European Patent Package, or EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (“UPC”), for litigation involving European patents. Implementation of the EU Patent Package occurred in 2023. Under the UPC, all European patents, including those issued prior to ratification of the European Patent Package, will by default automatically fall under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents and allow for the possibility of a competitor to obtain pan-European injunctions. It will be several years before we will understand the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. Under the EU Patent Package as currently proposed, we will have the right to opt our patents out of the UPC over the first seven years of the court’s existence, but doing so may preclude us from realizing the benefits of the new unified court.

Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.

Obtaining and enforcing patents in the pharmaceutical industry is inherently uncertain, due in part to ongoing changes in the patent laws. For example, in the United States, depending on decisions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation thereof, could change in unpredictable ways that could weaken our and our collaborators’ or licensors’ ability to obtain new patents or to enforce existing or future patents. For example, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Therefore, there is increased uncertainty with regard to our and our collaborators’ or licensors’ ability to obtain patents in the future, as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our and our collaborators’ or licensors’ patent applications and the enforcement or defense of our or our collaborators’ or licensors’ issued patents. For example, assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the “Leahy-Smith Act”), enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The Leahy-Smith Act also includes a number of significant changes that affect the way patent applications are prosecuted and may also affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our or our licensors’ patent applications and the enforcement or defense of our or our licensors’ issued patents. Similarly, statutory or judicial changes to the patent laws of other countries may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Any of the foregoing could harm our business, financial condition, results of operations and prospects.

We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged.

We are not aware that our patents directed to BIV201 are infringed by third parties. However, there can be no assurance that our patents will not be found in the future to be infringed by others. Any patents we do obtain may be challenged by reexamination or otherwise invalidated or eventually found unenforceable. Both the patent application process and the process of managing patent disputes can be time-consuming and expensive.

Significantly, our pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from such applications. Our ability to enforce patent rights also depends on our ability to identify infringement. It may be difficult to identify infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents or that our patents are invalid or unenforceable. In a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology. An adverse result in any litigation proceeding could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly. We may find it impractical or undesirable to enforce our intellectual property against some 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 during prosecution. These assertions may also be based on information known to us or the USPTO. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards the applicable drug candidates or technology related to the patent rendered invalid or unenforceable. Such a loss of patent rights could have a material adverse effect on our business, financial condition and result of operations.

Interference proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. If the prevailing party does not offer us a license on commercially reasonable terms or at all there could be a material adverse effect on our business, financial condition and results of operations.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation.

The pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Moreover, the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management’s efforts. We may not have sufficient resources to bring any such action to a successful conclusion. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations and you could lose all of your investment.

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 operation and prospects.

We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might subject us to infringement claims or adversely affect our ability to develop and market our drug candidates.

We cannot guarantee that any of our or our licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our drug candidates in any jurisdiction. For example, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the United States remain confidential until patents issue. As mentioned above, patent applications in the United States and elsewhere are published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our drug candidates could have been filed by third parties without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our drug candidates or the use of our drug candidates. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact our ability to market our drug candidates. We may incorrectly determine that our drug candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our ability to develop and market our drug candidates. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our drug candidates.

In addition, if we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, which may be significant, we may be temporarily or permanently prohibited from commercializing any of our drug candidates that are held to be infringing. We might, if possible, also be forced to redesign drug candidates so that they no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business and could adversely affect our business, financial condition, results of operations and prospects.

Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell our drug candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and other proprietary rights of third parties. There is considerable intellectual property litigation in the pharmaceutical industry. We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our drug candidates and their manufacture and our other technology, including reexamination, interference, post-grant review, inter partes review or derivation proceedings before the USPTO or an equivalent foreign body. Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing our drug candidates. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future, regardless of their merit.

We do not believe that BIV201 infringes the patents of any third parties. However, there can be no assurance that our technology will not be found in the future to infringe the patents of others. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products or product candidates infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes.

Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope, infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable and infringed, which could have a material adverse effect on our ability to commercialize any drug candidates we may develop and any other drug candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent.

If we are found to infringe, misappropriate or otherwise violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such rights are invalid or unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be or may become non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. A finding of infringement could prevent us from commercializing our drug candidates or force us to cease some of our business operations. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties and other fees, redesign our infringing drug candidate or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

We may be subject to claims by third parties asserting that we or our employees have infringed, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.

Many of our employees were previously employed at other biotechnology or pharmaceutical companies. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s former employer. We may also be subject to claims that patents and applications we have filed to protect inventions made on our behalf by our employees, consultants and advisors, even those related to one or more of our drug candidates, are rightfully owned by their former or concurrent employer. Litigation may be necessary to defend against these claims.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs, delay development of our drug candidates and be a distraction to management. Any of the foregoing events would harm our business, financial condition, results of operations and prospects.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest (including co-ownership or ownership) in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we or our licensors or collaborators may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved in developing our drug candidates. While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or our or our licensors’ or collaborators’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we or our licensors or collaborators fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our drug candidates. Even if we are successful in defending against such claims, these claims may create considerable distraction to management and other employees of the company. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection, if any, afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

others may be able to make products that are similar to any drug candidates we may develop or utilize similar technology but that are not covered by the claims of the patents that we license or may own in the future;

we, or our current or future licensors or collaborators, might not have been the first to make the inventions covered by the issued patent or pending patent application that we license or may own in the future;

we, or our current or future licensors or collaborators might not have been the first to file patent applications covering certain of our or their inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

it is possible that our pending owned or licensed patent applications or those that we may own or license in the future will not lead to issued patents;

issued patents that we hold rights to may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;

we may develop additional proprietary technologies that are patentable;

the intellectual property rights of others may harm our business; and

we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent directed to such intellectual property.

Should any of these events occur, they could harm our business, financial condition, results of operations and prospects.

Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of shares of our common stock to decline.

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of our existing products, programs or intellectual property could be diminished. Accordingly, the market price of shares of our common stock may decline. Such announcements could also harm our reputation or the market for our future products, which could have a material adverse effect on our business, financial condition and results of operations.

Risks Related to the Separation and Our Relationship with BioVie

After this offering, we will depend on BioVie to provide us with certain services for our business. Accordingly, we are subject to the business risks of BioVie.

After the Separation, BioVie will continue to manage and support our business. Therefore, any event that adversely effects BioVie’s business, financial condition or results of operations, may adversely affect us.

Accordingly, we are subject to the business risks of BioVie, including, but not limited to:

	·	third party contractors not successfully carrying out contractual duties or meeting deadlines, therefore unable to obtain regulatory approval or commercialize product candidates;
	·	uncertainty of successful development of biopharmaceuticals;
	·	concentration of assets within certain financial institutions;
	·	securities class action litigation;
	·	lack of products for commercial sale and revenue;
	·	approval of generic versions of any product candidates that receive marketing approval;
	·	failure to maintain Orphan Drug exclusivity for BIV201;
	·	raising substantial additional capital in the future to fund operations;
	·	limited experience in drug development;
	·	development of pharmaceuticals being time consuming;
	·	expenditure of limited resources to pursue a particular drug candidate;
	·	lack of manufacturing experience;
	·	lack of sales and marketing personnel to sell products;
	·	failure to comply with manufacturing regulations;
	·	complying with significant and complex government regulations;
	·	loss of availability of management;
	·	inability to attract and retain highly skilled personnel; and
	·	conflicts of interest among officers, directors and stockholders.

Please see Item 1A, “Risk Factors” in BioVie’s Annual Report on Form 10-K for the year ended June 30, 2025 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 (which are not, and shall not be deemed to be, incorporated by reference herein) for a full discussion of the risks associated with BioVie’s business.

We have no recent history of operating as a standalone public company, and our historical financial information may not necessarily reflect the results that we would have achieved as a standalone public company or what our results may be in the future.

Since our inception, we have been a wholly owned subsidiary of BioVie. The historical financial information included in this prospectus has been prepared from BioVie’s historical accounting records and is derived from the financial statements of BioVie to present the Company as if it had been operating on a standalone basis. Accordingly, this information may not necessarily reflect what our financial condition, results of operations or cash flows would have been had we been a standalone company during the periods presented or what our financial condition, results of operations and cash flows may be in the future, primarily because of the following factors:

Prior to the Separation, our business has been operated by BioVie as part of its broader corporate organization, rather than as a standalone company. BioVie or one of its affiliates performed various corporate functions for us, including finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance and other professional services.

Our historical financial results reflect the direct and indirect costs for the services historically provided by BioVie to us. Pursuant to a management services agreement, BioVie will provide us with the services of certain of its executive officers and other employees to support our operations following the completion of this offering in exchange for a quarterly fee. See “Certain Relationships and Related Party Transactions—Agreements to be Entered into in Connection with the Separation—Management Services Agreement.”

Our working capital requirements and capital expenditures have historically been satisfied as part of BioVie’s corporate-wide cash management and centralized funding programs, and our cost of debt and other capital may differ significantly from the historical amounts reflected in our historical carve-out financial statements.

Currently, our business is under common ownership with the other businesses of BioVie, and we benefit from BioVie’s size and scale, including with respect to costs, employees and relationships with customers and third-party partners. Although we will enter into a management services agreement with BioVie in connection with the Separation, these arrangements will not fully capture the benefits that we have enjoyed as a result of being under common ownership with BioVie, and the costs we will incur as a standalone public company may significantly exceed comparable costs we would have incurred as part of BioVie.

For additional information about the past financial performance of our business and the presentation of financial information of the historical carve-out financial statements of our business included in this prospectus, see “Presentation of Financial Information” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our carve-out financial statements and the notes to those statements included elsewhere in this prospectus.

We may not achieve some or all of the expected benefits of the Separation, and the Separation could adversely affect our business, financial condition and results of operations.

We may not be able to achieve the full strategic and financial benefits expected to result from the Separation, or the benefits may be delayed or not occur at all. We expect that the Separation will improve our strategic and operational flexibility; provide the executive leadership and the Board the opportunity to focus solely on our business; provide us with a unique and more efficiently valued equity currency to commercialize our drug candidates and other capital needs; allow us to adopt the capital structure, investment policy and dividend policy best suited to our financial profile and business needs; provide us with a more effective tool for employee compensation; and enable investors to invest directly in us.

We may not achieve these and other anticipated benefits of the Separation following the completion of this offering for a variety of reasons, including:

the Separation will require significant amounts of management’s time and effort, which may divert management’s attention from operating and growing our business;

we may be more susceptible to economic downturns and other adverse events than we were prior to the Separation;

our business will be less diversified than BioVie’s businesses prior to the Separation;

the cost of capital for our business may be higher than BioVie’s cost of capital prior to the Separation;

certain costs and liabilities that were otherwise less significant to BioVie as a whole will be more significant to us as a standalone company; and

other actions required to separate the respective businesses could disrupt our operations.

If we fail to achieve some or all of the benefits expected to result from the Separation, or if the benefits are delayed, our business, financial condition and results of operations could be adversely affected.

Until the Separation is completed, BioVie has sole discretion to change the terms of the Separation in ways that may be unfavorable to us.

Until the Separation is completed, we will be a wholly owned subsidiary of BioVie. Accordingly, BioVie will effectively have the sole and absolute discretion to determine and change the terms of the Separation. These changes could be unfavorable to us. In addition, BioVie may decide at any time not to proceed with the Separation.

Following the completion of this offering, BioVie will continue to control the direction of our business, and the concentrated ownership of our common stock may prevent you and other stockholders from influencing significant decisions.

Upon completion of this offering, we expect that BioVie will own approximately 64% of our outstanding common stock (or approximately 60% if the underwriters exercise their over-allotment option to purchase additional shares of our common stock in full). Investors in this offering generally will not be able to affect the outcome of any matter submitted to our stockholders for approval as long as BioVie or its successor-in-interest beneficially owns a majority of the total voting power of our outstanding common stock.

As long as BioVie beneficially owns a majority of the voting power of our outstanding common stock, BioVie will generally be able to control the outcome of matters submitted to our stockholders for approval without the approval of our other stockholders, including:

determinations with respect to our business direction and policies, including the election and removal of directors and the appointment and removal of officers;

determinations with respect to corporate transactions, such as mergers, business combinations or dispositions of assets;

our financing and dividend policies;

our compensation and benefit programs and other human resources policy decisions;

termination of, changes to or determinations under our agreements with BioVie relating to the Separation;

determinations with respect to tax matters; and

changes to any other agreements that may adversely affect us.

If BioVie does not dispose of its remaining equity interest in our company, or if BioVie purchases shares of our common stock in the open market following the completion of this offering, it could remain our controlling stockholder for an extended period of time or indefinitely. Even if BioVie were to beneficially own less than a majority of the total voting power of our outstanding common stock, BioVie may be able to influence the outcome of corporate actions requiring stockholder approval for as long as it owns a significant portion of our common stock.

BioVie’s interests may not be the same as, or may conflict with, the interests of our other stockholders. Actions that SMC takes with respect to us, as a controlling or significant stockholder, may not be favorable to us or our other stockholders.

We will be a “controlled company” within the meaning of NYSE rules and, as a result, we will qualify for, and intend to rely on, exemptions from certain corporate governance requirements.

Upon completion of this offering, BioVie will own more than a majority of the voting power of our outstanding common stock eligible to vote in the election of our directors. As a result, we will be a “controlled company” within the meaning of NYSE corporate governance standards. Under NYSE rules, a company of which more than 50% of the voting power is held by an individual, group or another company is a “controlled company” and may elect not to comply with certain NYSE corporate governance standards, including:

the requirement that a majority of the Board consist of independent directors;

the requirement to have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities;

the requirement to have a nominating and governance committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities, or otherwise have director nominees selected by vote of a majority of the independent directors; and

the requirement for an annual performance evaluation of the nominating and governance and compensation committees.

Upon completion of this offering, the Board will not have a compensation committee, but it intends to establish a compensation committee in the future. We may take advantage of one or more other of these exemptions in the future. As a result, you may not have the same protections afforded to stockholders of companies that are subject to all the corporate governance requirements of NYSE.

Following the completion of this offering, we and our stockholders may have conflicts of interest with BioVie.

Conflicts of interest may arise between BioVie and us after the offering, since BioVie will continue to engage in transactions with us. Further, BioVie may, from time to time, acquire and hold interests in, or maintain business relationships with, businesses that compete directly or indirectly with us. In general, BioVie could pursue business interests or exercise its voting power as stockholder in ways that are detrimental to us but beneficial to themselves or to other companies in which they invest or with whom they have relationships.

In addition, adverse publicity, regulator scrutiny and pending investigations by regulators or law enforcement agencies involving BioVie could negatively impact our reputation due to our relationship with BioVie, which could have a material adverse effect on our business, financial condition and results of operations.

A Distribution may not occur and your investment in our securities may be adversely affected if BioVie does not distribute the shares of our common stock owned by BioVie.

We are currently a wholly owned subsidiary of BioVie. Accordingly, BioVie holds all of our outstanding shares of common stock. Following the completion of this offering, we expect that BioVie will own approximately 64% of our outstanding common stock (or approximately 60% if the underwriters exercise their over-allotment option to purchase additional shares of our common stock in full). BioVie has advised us that, following the completion of this offering and subject to the expiration of any applicable lock-up periods or other agreements we have or may have with BioVie, it does not have any near-term plans to distribute the shares of our common stock currently held by it to BioVie’s stockholders. Whether a Distribution is conducted in the future will depend on many factors, including BioVie’s cash position, market capitalization, BioVie’s investment opportunities, taxation to BioVie and BioVie’s shareholders and our status and prospects. In addition, the liquidity of the market for our common stock may be constrained for as long as BioVie continues to hold a significant position in our common stock. Additionally, without a Distribution, there will be limited liquidity in the market for our common stock, which will impact our stockholders and our stock price. A lack of liquidity in the market for our common stock may adversely affect our stock price and therefore, our ability to raise additional funds in the public markets, which could have a material adverse effect on our ability to grow our business.

We will incur significant charges in connection with the Separation and incremental costs as a standalone public company.

We expect the separation process to be complex, time-consuming and costly. We will need to establish or expand our own corporate functions, including finance, human resources, benefits administration, procurement support, information technology, legal, corporate governance and other professional services. We will also need to make investments or hire additional employees to operate without the same access to BioVie’s existing operational and administrative infrastructure. We expect to incur one-time costs to replicate, or outsource from other providers, these corporate functions to replace the corporate services that BioVie historically provided to us prior to the Separation. Any failure or significant downtime in our own financial, administrative or other support systems, or in the BioVie financial, administrative or other support systems during the transitional period during which BioVie provides us with support, could adversely affect our business, financial condition and results of operations, such as by preventing us from paying our suppliers and employees, executing business combinations and foreign currency transactions, or performing administrative or other services on a timely basis. Due to the scope and complexity of the underlying projects related to the Separation, the amount of total costs could be materially higher than our estimate, and the timing of the incurrence of these costs is subject to change.

In addition, our financial statements include the assets, liabilities, revenue and expenses that management has determined are specifically or primarily identifiable to us, as well as direct and indirect costs that are attributable to our operations. Indirect costs are the costs of support functions that are provided on a centralized basis by BioVie and its affiliates. Indirect costs have been allocated to us for the purposes of preparing our historical carve-out financial statements based on a specific identification basis or, when specific identification is not practicable, a proportional cost allocation method, primarily based on headcount or other allocation methodologies that are considered to be a reasonable reflection of the utilization of services provided or the benefit received by us during the periods presented, depending on the nature of the services received. The value of the assets and liabilities we assume in connection with the Separation could ultimately be materially different than these attributions, which could adversely affect our business, financial condition and results of operations.

After this offering, our directors and executive officers may have actual or potential conflicts of interest because of their current BioVie positions or their equity ownership in BioVie.

Each of our directors and executive officers have been, and are expected to continue to be, BioVie directors and executive officers. In addition, because of their current BioVie positions, our directors and executive officers own shares of BioVie’s common stock or other equity compensation awards. For some of these individuals, their individual holdings may be significant compared to their total assets. These relationships and financial interests may create, or may create the appearance of, conflicts of interest when these directors and officers are faced with decisions that could have different implications for BioVie and us. For example, potential conflicts of interest could arise over matters such as the desirability of changes in our business and operations, funding and capital matters, regulatory matters, matters arising with respect to the separation agreement and other agreements with BioVie relating to the Separation or otherwise, employee retention or recruiting or our dividend policy. We expect that provisions relating to certain relationships and transactions in our amended and restated certificate of incorporation will address certain actual or potential conflicts of interest between us, on the one hand, and BioVie and its directors and officers who are our directors and officers on the other hand. By becoming our stockholder, you will be deemed to have notice of, and consented to, these provisions of our amended and restated certificate of incorporation. For example, we are expected to renounce any interest or expectancy of ours in any corporate opportunities that are presented to our directors and officers who are also directors and officers of BioVie, and such director or officer will have no duty to communicate or present such corporate opportunity to us, in each case so long as such corporate opportunity was not expressly offered to such person solely in their capacity as our director or officer. Although these provisions are designed to resolve certain conflicts of interest between us and BioVie fairly, we cannot assure you that any conflicts of interest will be so resolved.

Certain contracts used in our business will need to be replaced, or assigned from BioVie or its affiliates to the Company in connection with the Separation, which may require the consent of the counterparty to such an assignment, and failure to obtain such replacement contracts or consents could increase the Company’s expenses or otherwise adversely affect our results of operations.

Our separation from BioVie requires us to replace shared contracts and, with respect to certain contracts that are to be assigned from BioVie or its affiliates to us or our affiliates, to obtain consents and assignments from third parties. It is possible that, in connection with the replacement or consent process, some parties may seek more favorable contractual terms from the Company. If we are unable to obtain such replacement contracts or consents, as applicable, we may be unable to obtain some of the benefits, assets and contractual commitments that are intended to be allocated to the Company as part of the Separation. If the Company is unable to obtain such replacement contracts or consents, the loss of these contracts could increase the Company’s expenses which could have a material adverse effect on our business, financial condition and results of operations.

If BioVie sells a controlling equity interest in our company to a third party in a private transaction, you may not realize any change-of-control premium on your shares of our common stock and we may become subject to the control of a currently unknown third party.

Upon completion of this offering, we expect that BioVie will own approximately 64% of our outstanding common stock (or approximately 60% if the underwriters exercise their over-allotment option to purchase additional shares of our common stock in full). BioVie will have the ability, should it choose to do so, to sell some or all of its shares of our common stock in a privately negotiated transaction, which, if sufficient in size, could result in a change of control of us.

The ability of BioVie to privately sell its shares of our common stock, with no requirement for a concurrent offer to be made to acquire all of the shares of our common stock that will be publicly traded following the completion of this offering, could prevent you from realizing any change-of-control premium on your shares of our common stock that may otherwise accrue to BioVie on its private sale of shares of our common stock. In addition, if BioVie privately sells its controlling equity interest in our company, we may become subject to the control of a currently unknown third party. The interests of this third party may not be the same as, or may conflict with, the interests of our other stockholders. Furthermore, if BioVie sells a controlling equity interest in our company to a third party, our future indebtedness may be subject to acceleration, and our other commercial agreements and relationships, including any remaining agreements with BioVie, could be impacted. The occurrence of any of these events could adversely affect our business, financial condition and results of operations.

Potential indemnification obligations to BioVie in connection with the Separation could adversely affect our business, financial condition and results of operations.

The separation agreement will provide for indemnification obligations (for uncapped amounts, reduced by any insurance proceeds or other third-party proceeds that the party being indemnified receives) designed to make us financially responsible for substantially all liabilities that may exist relating to our business activities, whether incurred prior to or following the completion of this offering. In addition, we will agree to indemnify BioVie under certain additional circumstances pursuant to certain other agreements we will enter into with BioVie in connection with the Separation. If we are required to indemnify BioVie under the circumstances set forth in these agreements, we may be subject to substantial liabilities, which could adversely affect our business, financial condition and results of operations.

In connection with the Separation, BioVie will indemnify us for certain liabilities. However, we cannot assure you that the indemnity will be sufficient to insure us against the full amount of such liabilities or that BioVie’s ability to satisfy its indemnification obligation will not be impaired in the future.

Pursuant to the separation agreement and certain other agreements we will enter into with BioVie in connection with the Separation, BioVie will agree to indemnify us for certain liabilities. However, third parties could also seek to hold us responsible for any of the liabilities that BioVie has agreed to retain and we cannot assure you that the indemnity from BioVie will be sufficient to protect us against the full amount of such liabilities, or that BioVie will be able to fully satisfy its indemnification obligations. In addition, pursuant to the separation agreement, BioVie’s self-funded insurance policies will not be available to us, and BioVie’s third-party insurance policies may not be available to us, for liabilities associated with occurrences of indemnified liabilities prior to the Separation, and in any event BioVie’s insurers may deny coverage to us for liabilities associated with certain occurrences of indemnified liabilities prior to the Separation. Moreover, even if we ultimately succeed in recovering from BioVie or its insurance providers any amounts for which we are held liable, we may be temporarily required to bear these losses. The occurrence of any of these events could adversely affect our business, financial condition and results of operations.

We may have received better terms from unaffiliated third parties than the terms we will receive in our agreements with BioVie.

The agreements we will enter into with BioVie in connection with the Separation were prepared in the context of our separation from BioVie while we were still part of BioVie. Accordingly, during the period in which these agreements were prepared, we did not have a separate or independent board of directors or a management team that was separate from or independent of BioVie. The terms of these agreements, including the fees charged for services provided under these agreements, were primarily determined by BioVie and, as a result, may not necessarily reflect terms that would have resulted from arm’s-length negotiations between unaffiliated third parties or from arm’s-length negotiations between BioVie and an unaffiliated third party in another form of transaction, such as a buyer in a sale of a business transaction.

Approval of commercial terms between us and BioVie does not preclude the possibility of stockholder litigation, including but not limited to derivative litigation nominally against BioVie and against its directors and officers and also against us and our directors and officers.

The commercial terms of the separation agreement and management services agreement that we will enter into with BioVie have not been negotiated on behalf of BioVie by persons consisting solely of disinterested BioVie directors. Notwithstanding the foregoing, we have no basis for believing that the terms of these agreements will not be in the best interests of both BioVie and its stockholders and also us and our stockholders. Nonetheless, no assurance can be given that any stockholder of BioVie will not claim in a lawsuit that such terms in fact are not in the best interests of BioVie and its stockholders, that the directors and officers of BioVie breached their fiduciary duties in connection with such agreements and that any disclosures by BioVie to its stockholders regarding these agreements and the relationship between BioVie and us did not satisfy applicable requirements. In any such instance, we and our directors and officers may also be named as defendants and we would have to defend ourselves and our directors and officers. While we will seek indemnification from BioVie under the terms of these agreements against any damages or other costs, which could be substantial, no such indemnification has yet been agreed to or may be agreed to and be in effect. Further, any such litigation would be time-consuming and would divert focus and resources from the development of our product candidates and our business, including but not limited to possibly delaying our clinical trials due to our management having to spend time and attention on such litigation.

Following this offering, we will continue to depend on BioVie to provide us with certain services for our business.

We are currently a wholly owned subsidiary of BioVie. After the Separation, certain services required by us for the operation of our business will be provided by BioVie, including certain finance, accounting, compliance and regulatory services. At our election, or if BioVie does not or is unable to perform its obligations under the management services agreement, we will be required to provide these services ourselves or to obtain substitute arrangements with other third parties. We may be unable to provide these services because of financial or other constraints or be unable to implement substitute arrangements on a timely basis on terms that are favorable to us, or at all.

Certain of BioVie’s executive officers will devote a portion their time to us as our executive officers to assist in preparing for the Phase 3 trial of BIV201. We anticipate such executive officers to devote up to 20% of their time on a monthly basis to the Company as they assist us in preparing for the Phase 3 trial of BIV201. As the Phase 3 trial begins and the trial proceeds, the percentage of time such executive officers devote is expected to increase. In addition, we may employ additional executive officers or employees at any time.

We will exercise no control over the activities of BioVie other than the contractual rights we will have pursuant to our management services agreement. Because of our historical relationship with BioVie, our reputation is also tied to BioVie. We may be subject to reputational harm, or our relationships with existing and potential clients, third-party research organizations, consultants and other business partners could be harmed if BioVie or any of its affiliates, previously, or in the future, among other things, engages in poor business practices, restructures or files for bankruptcy, becomes subject to litigation or otherwise damages its reputation or business prospects. Any of these events might in turn adversely affect our reputation, revenues and/or business prospects, and may also adversely affect our access to BioVie’s collaborative services.

Furthermore, certain individuals conducting services on our behalf are not our employees, and except for remedies available to us under our agreements with BioVie, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing development programs. We also cannot ensure that BioVie retains sufficient resources of personnel or otherwise to conduct its operations. BioVie may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting research and development activities, which could impede their ability to devote appropriate time to our research and development programs. In addition, if we fail to comply with our diligence, payment or other obligations under the agreements, any such collaboration may terminate or we may not be able to successfully negotiate agreements for future product candidates or collaborations with BioVie.

The assets and resources that we acquire from BioVie in the Separation may not be sufficient for us to operate as a stand-alone company, and we may experience difficulty in separating our assets and resources from BioVie.

Because we have not operated as a standalone company in the past, we may have difficulty doing so. We may need to acquire assets and resources in addition to those provided by BioVie to us, and in connection with the Separation, may also face difficulty in separating our resources from BioVie’s and integrating newly acquired assets into our business. For example, we may need to hire additional personnel to assist with administrative and technical functions and acquire other office and laboratory equipment for use in the ordinary course operations of our business. If we have difficulty operating as a stand-alone company, fail to acquire assets that we need to run our operations, or incur unexpected costs in separating our business from BioVie’s business or in integrating newly acquired assets into our business, our financial condition and results of operations will be adversely affected.

Risks Related to this Offering and Ownership of Our Common Stock

You will experience immediate and substantial dilution as a result of this offering.

You will incur immediate and substantial dilution as a result of this offering. After giving effect to the assumed sale by us of 1,818,182 shares of our common stock at an assumed public offering price of $11.00 per share of common stock (excluding the exercise of the underwriters’ over-allotment option to purchase additional shares and after deducting underwriting discounts, commissions and estimated offering expenses payable by us), investors in this offering can expect an immediate dilution of $7.44 per share of common stock. In addition, you will experience further dilution if the underwriters exercise their over-allotment option.

Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to the 2026 Plan, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline.

We may issue additional securities following the closing of this offering. In the future, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. We also expect to issue common stock to employees, including our executive officers, consultants and directors, pursuant to the 2026 Plan. If we sell common stock, convertible securities or other equity securities in subsequent transactions, or common stock is issued pursuant to the 2026 Plan investors may be materially diluted. New investors in such subsequent transactions could gain rights, preferences and privileges senior to those of holders of our common stock.

There is no liquid public market for our common stock and we do not know whether one will develop to provide you with adequate liquidity. If our share price fluctuates after this offering, you could lose a significant part of your investment.

Prior to this offering, there has not been a liquid public market for our common stock. If an active trading market does not develop, you may have difficulty selling any of our common stock that you buy. We cannot predict the extent to which investor interest in the Company will lead to the development of an active trading market on NYSE or otherwise or how liquid that market might become. The initial public offering price for our common stock will be determined by negotiations between us and the underwriters and may not be indicative of prices that will prevail in the open market following this offering. Consequently, you may not be able to sell our common stock at prices equal to or greater than the price paid by you in this offering. In addition to the risks described above, the market price of our common stock may be influenced by many factors, some of which are beyond our control, including actual or anticipated variations in our operating results; the failure of financial analysts to cover our common stock after this offering or changes in financial estimates by financial analysts, or any failure by us to meet or exceed any of these estimates or changes in the recommendations of any financial analysts that elect to follow our common stock or the shares of our competitors; announcements by us or our competitors of significant contracts or acquisitions; technological innovations by us or our competitors; future sales of our common stock; and investor perceptions of us and the market in which we operate.

Management will have broad discretion as to the use of the proceeds from this offering, and may not use the proceeds effectively.

Our management will have broad discretion as to the use of the net proceeds from any offering by us and could use them for purposes other than those contemplated at the time of this offering. Accordingly, you will be relying on the judgment of our management with regard to the use of these net proceeds, and you will not have the opportunity, as part of your investment decision, to assess whether the proceeds are being used appropriately. It is possible that the proceeds will be invested in a way that does not yield a favorable, or any, return for our company.

We have no operating experience as a public company.

We have no operating experience as a public company. Although the individuals who now constitute our management team have experience managing a public company, there is no assurance that the past experience of our management team will be sufficient to operate our company as a public company, including timely compliance with the disclosure requirements of the SEC. Following the completion of this offering, we will be required to develop and implement internal control systems and procedures in order to satisfy the periodic and current reporting requirements under applicable SEC regulations and comply with NYSE listing standards. These requirements will place significant strain on our management team, infrastructure and other resources. In addition, our management team may not be able to successfully or efficiently manage our company as a public reporting company that is subject to significant regulatory oversight and reporting obligations.

The market price and trading volume of our common stock may be volatile.

The market price and trading volume of our common stock may be volatile. The market price of our common stock may fluctuate significantly for many reasons, including in response to the risk factors described in this prospectus or for reasons unrelated to our specific performance. In recent years, the stock market has experienced extreme price and volume fluctuations. This volatility has affected the market prices of securities issued by many companies for reasons unrelated to their operating performance and may adversely affect the market price and trading volume 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 perceptions about us and our business, our future financial results, the absence of cash dividends on our common stock and general 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.

We cannot assure you that we will be able to comply with the minimum bid price requirement of NYSE.

Although we expect our stock price will meet such minimum bid price requirements prior to the effective date of the registration statement of which this prospectus forms a part, there is no guarantee that the price of our common stock will stay above the minimum requirements for the time period required by NYSE. Further, there can be no assurance that the market price of our common stock will remain at the level required for continuing compliance with the minimum price requirements. It is not uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split. If the market price of our common were to experience such a decline, or if other factors unrelated to the number of shares of our common stock outstanding, such as negative financial or operational results, adversely affect the market price of our common stock, that may jeopardize our ability to meet or maintain the minimum bid price requirement of the exchange on which our common stock is listed.

Our inability to comply with NYSE's continued listing requirements could result in our common stock being delisted, which could affect the market price and liquidity of our securities and reduce our ability to raise capital.

We intend to apply to list our common stock on NYSE under the symbol “OPTN”. No assurance can be given that our application will be approved. However, if such listing is approved, upon completion of this offering, we will be required to meet certain qualitative and financial tests to maintain the listing of our common stock on NYSE. If we do not maintain compliance with NYSE’s continued listing requirements within specified periods and subject to permitted extensions, our common stock may be recommended for delisting (subject to any appeal we would file). No assurance can be provided that we will comply with these continued listing requirements. NYSE has broad discretionary authority over the continued listing of securities, which it could exercise with respect to the listing of our common stock. If our common stock were delisted, it could be more difficult to buy or sell our common stock and to obtain accurate quotations, and the price of our securities could suffer a material decline. Delisting would also impair our ability to raise capital.

An investment in our securities involves significant risks.

Additional risks and uncertainties not presently known to us or that we currently consider immaterial may also impair our business and operations and cause the trading price of our securities to decline, which could have a material adverse effect on our business, financial condition and results of operations. In that event, the trading price of our securities could decline and security holders could lose all or part of their investment. There is no assurance that risk management steps taken will avoid future loss due to the occurrence of the risks described below or other unforeseen risks.

Our common stock may experience extreme stock price volatility unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.

Recently, there have been instances of extreme stock price run-ups followed by rapid price declines and strong stock price volatility with a number of recent initial public offerings, especially among companies with relatively smaller public floats. As a relatively small-capitalization company with relatively small public float, we may experience greater stock price volatility, extreme price run-ups, lower trading volume and less liquidity than large-capitalization companies. In particular, our common stock may be subject to rapid and substantial price volatility, low volumes of trades and large spreads in bid and ask prices. Such volatility, including any stock-run up, may be unrelated to our actual or expected operating performance, financial condition or prospects, making it difficult for prospective investors to assess the rapidly changing value of our common stock.

In addition, if the trading volumes of our common stock are low, persons buying or selling in relatively small quantities may easily influence prices of our common stock. This low volume of trades could also cause the price of our common stock to fluctuate greatly, with large percentage changes in price occurring in any trading day session. Holders of our common stock may also not be able to readily liquidate their investment or may be forced to sell at depressed prices due to low volume trading. If high spreads between the bid and ask prices of our common stock exist at the time of a purchase, the stock would have to appreciate substantially on a relative percentage basis for an investor to recoup their investment. Broad market fluctuations and general economic and political conditions may also adversely affect the market price of our common stock.

As a result of this volatility, investors may experience losses on their investment in our common stock. A volatile market price of our common stock also could adversely affect our ability to issue additional shares of common stock or other securities and our ability to obtain additional financing in the future.

Any failure to maintain effective internal control over financial reporting could harm us.

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”). 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.

If we are unable to assert that our internal control over financial reporting is effective, or when required in the future, if our independent registered public accounting firm is unable to express an unqualified opinion as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our common stock could be adversely affected and we could become subject to litigation or investigations by the stock exchange on which our securities are listed, the SEC or other regulatory authorities, which could require additional financial and management resources.

We are an emerging growth company within the meaning of the Securities Act and may take advantage of certain reduced reporting requirements applicable to other public companies that are not emerging growth companies.

We will be an “emerging growth company” as defined in section 3(a) of the Exchange Act (as amended by the JOBS Act), and will continue to qualify as an emerging growth company until the earliest of: (a) the last day of the fiscal year during which we have total annual gross revenues of at least $1.235 billion; (b) the last day of our fiscal year following the fifth anniversary of the completion of this offering; (c) the date on which we have, during the preceding three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer” under the Exchange Act, which would occur if the market value of shares of our common stock held by non-affiliates exceeds $700 million.

For so long as we remain an emerging growth company, we are permitted to and may rely upon exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include not being required to comply with the auditor attestation requirements of Section 404. We cannot predict whether investors will find our securities less attractive because we rely upon certain of these exemptions. If some investors find the securities less attractive as a result, there may be a less active trading market for our securities and the price of our securities may be more volatile. On the other hand, if we no longer qualify as an emerging growth company, we would be required to divert additional management time and attention from development and other business activities and incur increased legal and financial costs to comply with the additional associated reporting requirements, which could negatively impact our business, financial condition and results of operations.

We are considered a smaller reporting company that is exempt from certain disclosure requirements, which could make our stock less attractive to potential investors.

Rule 12b-2 of the Exchange Act defines a “smaller reporting company” as an issuer that is not an investment company, an asset-backed issuer, or a majority-owned subsidiary of a parent that is not a smaller reporting company and that:

Had a public float of less than $250 million as of the last business day of its most recently completed fiscal quarter, computed by multiplying the aggregate number of worldwide number of shares of its voting and non-voting common equity held by non-affiliates by the price at which the common equity was last sold, or the average of the bid and asked prices of common equity, in the principle market for the common equity; or

In the case of an initial registration statement under the Securities Act or the Exchange Act for shares of its common equity, had a public float of less than $250 million as of a date within 30 days of the date of the filing of the registration statement, computed by multiplying the aggregate worldwide number of such shares held by non-affiliates before the registration plus, in the case of a Securities Act registration statement, the number of such shares included in the registration statement by the estimated public offering price of the shares; or

In the case of an issuer who had annual revenue of less than $100 million during the most recently completed fiscal year for which audit financial statements are available, had a public float as calculated under paragraph (1) or (2) of this definition that was either zero or less than $700 million.

As a “smaller reporting company” we are not required and may not include a Compensation Discussion and Analysis section in our proxy statements; we provide only three years of business development information; and have other “scaled” disclosure requirements that are less comprehensive than issuers that are not “smaller reporting companies” which could make our stock less attractive to potential investors, which could make it more difficult for you to sell your shares.

Because we do not intend to pay any cash dividends on our common stock, our stockholders will not be able to receive a return on their shares unless they sell them.

We intend to retain any future earnings to finance the development and expansion of our business. We do not anticipate paying any cash dividends on our common stock in the foreseeable future. Unless we pay dividends, our stockholders will not be able to receive a return on their shares of our common stock unless they sell them. There is no assurance that stockholders will be able to sell their shares of our common stock when desired.

We will be authorized to issue “blank check” preferred stock without stockholder approval, which could adversely impact the rights of holders of our securities.

Our amended and restated certificate of incorporation will authorize us to issue up to shares of blank check preferred stock. Any preferred stock that we issue in the future may rank ahead of our common stock in terms of dividend priority or liquidation premiums and may have greater voting rights than our common stock. Any preferred stock issued may contain provisions allowing those shares to be converted into shares of our common stock, which could dilute the value of our common stock to current stockholders and could adversely affect the market price, if any, of our common stock. The preferred stock could be utilized, under certain circumstances, as a method of discouraging, delaying, or preventing a change in control of our company. Although we have no present intention to issue any shares of our authorized preferred stock, there can be no assurance that we will not do so in the future.

Anti-takeover provisions in our organizational documents and Delaware law might discourage or delay acquisition attempts for us that you might consider favorable.

Our amended and restated certificate of incorporation and our amended and restated bylaws that will become effective prior to the consummation of this offering will contain provisions that may make a merger with or acquisition of our Company or changes in our management more difficult without the approval of the Board. Among other things, these provisions:

authorize the Board to issue, without further action by the stockholders, shares of preferred stock with terms, rights and preferences determined by the Board that may be senior to our common stock;

specify that special meetings of our stockholders proposals can only be brought by the Board, the chairperson of the Board, the lead independent director or our chief executive officer;

establish an advance notice procedure for stockholder proposals to be brought before an annual meeting, including proposed nominations of persons for election to the Board;

permit the Board to establish the number of directors and fill any vacancies and newly created directorships;

restrict the forum for certain litigation against us to Delaware;

establish advance notice requirements for nominations for election to the Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and

prohibit cumulative voting in the elections of directors.

Further, as a Delaware corporation, we are subject to provisions of Delaware law, which may impede or discourage a takeover attempt that our stockholders may find beneficial. These anti-takeover provisions and other provisions under Delaware law could discourage, delay or prevent a transaction involving a change in control of our Company, including actions that our stockholders may deem advantageous, or negatively affect the trading price of our common stock. These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing and to cause us to take other corporate actions you desire. For further discussion of these and other such anti-takeover provisions, see “Description of Our Securities—Anti-Takeover Effects of Various Provisions of Delaware Law, Our Amended and Restated Certificate of Incorporation and Our Amended and Restated Bylaws.”

Our amended and restated certificate of incorporation will contain exclusive forum provisions that may discourage lawsuits against us and our directors and officers.

Our amended and restated certificate of incorporation will provide that unless the Board otherwise determines, the state courts in the State of Delaware or, if no state court located within the State of Delaware has jurisdiction, the federal court for the District of Delaware, will be the sole and exclusive forum for any derivative action or proceeding brought on behalf of the Company, any action asserting a claim of breach of a fiduciary duty owed by any director or officer of the Company to us or our stockholders, any action asserting a claim against us or any director or officer of the Company arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation or bylaws, or any action asserting a claim against us or any director or officer of the Company governed by the internal affairs doctrine under Delaware law. Our amended and restated certificate of incorporation will further provide that the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. These exclusive forum provisions may limit the ability of our stockholders to bring a claim in a judicial forum that such stockholders find favorable for disputes with us or our directors or officers, which may discourage such lawsuits against us and our directors and officers. Alternatively, if a court were to find one or more of these exclusive forum provisions inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings described above, we may incur additional costs associated with resolving such matters in other jurisdictions or forums, which could adversely affect our business, financial condition, results of operations and prospects.

Any person or entity purchasing or otherwise acquiring any interest in any shares of our common stock shall be deemed to have notice of and to have consented to the forum provisions in the amended and restated certificate of incorporation. Although we believe these exclusive forum provisions benefit us by providing increased consistency in the application of Delaware law and federal securities laws in the types of lawsuits to which each applies, the exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers or stockholders or result in increased costs for a stockholder to bring a claim, which may discourage lawsuits with respect to such claims.

USE OF PROCEEDS

We estimate that the net proceeds from this offering will be approximately $17.0 million, or approximately $19.7 million if the underwriters exercise their over-allotment option to purchase additional shares of our common stock in full, assuming an initial public offering price of $11.00 per share (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We intend to use the net proceeds from this offering for working capital and general corporate purposes that are necessary in order to operate our company, which will include, among other things, the quarterly fee for support services to be provided under the management services agreement between us and BioVie, and all of the remaining net proceeds from this offering to fund the Phase 3 clinical trial of our investigational drug candidate BIV201 (continuous infusion terlipressin).

Each $1.00 increase (decrease) in the assumed public offering price of $11.00 per share of our common stock would increase (decrease) net proceeds to us by approximately $1.7 million (or approximately $1.9 million if the underwriters exercise their over-allotment option to purchase additional shares of our common stock in full), assuming the number of shares of common stock we sell, as set forth on the cover page of this prospectus, remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. Similarly, each increase (decrease) of 200,000 shares of common stock offered by us would increase (decrease) the net proceeds to us by $2.0 million (or approximately $2.3 million if the underwriters exercise their over-allotment option to purchase additional shares of our common stock in full), assuming the assumed public offering price remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

DIVIDEND POLICY

We have not declared or paid any cash dividends on our common stock to date. We may retain future earnings, if any, for future operations, expansion and debt repayment and have no current plans to pay cash dividends for the foreseeable future. Any decision to declare and pay dividends in the future will be made at the discretion of the Board and will depend on, among other things, our results of operations, financial condition, cash requirements, contractual restrictions and other factors that the Board may deem relevant and subject to applicable laws and the restrictions contained in any future financing instruments. We do not anticipate declaring any cash dividends to holders of our common stock in the foreseeable future.

CAPITALIZATION

The following table sets forth our capitalization as of December 31, 2025:

	·	on an actual basis;

	·	on an as adjusted basis to give effect to the issuance of an aggregate of 3,181,718 shares of our common stock to BioVie immediately prior to the consummation of this offering pursuant to the separation agreement; and

on a pro forma as adjusted basis to give effect to the sale of 1,818,182 shares of our common stock in this offering (assuming no exercise of the underwriters’ over-allotment option to purchase additional shares of our common stock) at the assumed public offering price of $11.00 per share of our common stock (which is the midpoint of the price range set forth on the cover page of this prospectus) and the application of the net proceeds therefrom, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

The cash and capitalization information in the following table may not necessarily reflect what our cash and capitalization would have been had we been operating as a standalone company as of December 31, 2025. In addition, the cash and capitalization information in the following table may not necessarily reflect what our cash and capitalization may be in the future.

This table should be read in conjunction with the “Management's Discussion and Analysis of Financial Condition and Results of Operations” and “Use of Proceeds” sections, as well as our audited carve-out financial statements, included elsewhere in this prospectus.

	As of December 31, 2025
	Actual (unaudited)		As adjusted (unaudited)		Pro forma as adjusted (unaudited)
Cash	$	—	$	—	$	16,996,220
Total liabilities		10,531		10,531		10,531
Common stock, $0.001 par value; 100 shares authorized, 100 shares issued and outstanding, actual; 500,000,000 shares authorized, 3,181,818 shares issued and outstanding, as adjusted; 500,000,000 shares authorized, 5,000,000 shares issued and outstanding, pro forma as adjusted		—		3,182		5,000
Total parent’s net investment/stockholder’s equity	$	1,195,703	$	18,191,923	$	18,191,923
Total capitalization	$	1,206,234	$	18,205,636	$	18,207,454

DILUTION

If you invest in our common stock in this offering, your interest will be immediately diluted to the extent of the difference between the public offering price per share of our common stock in this offering and the adjusted net tangible book value per share of our common stock after this offering. Dilution results from the fact that the public offering price per share of our common stock is substantially in excess of the net tangible book value per share of our common stock.

As of December 31, 2025, we had a net tangible book value of $7,863.39 per share of our common stock. Our net tangible book value per share represents total tangible assets less total liabilities, divided by the number of shares of our common stock outstanding on December 31, 2025.

After giving effect to the issuance of an aggregate of 3,181,718 shares of our common stock to BioVie immediately prior to the consummation of this offering pursuant to the separation agreement, our as adjusted net tangible book value as of December 31, 2025 was $0.25 per share of our common stock. This represents an immediate decrease in as adjusted net tangible book value of $7,863.14 per share of our common stock to our existing stockholder, BioVie.

After giving further effect to the sale of our common stock in this offering at an assumed public offering price of $11.00 per share of our common stock (which is the midpoint of the price range set forth on the cover page of this prospectus), after deducting the estimated underwriting discounts and commissions and estimated offering expenses, our pro forma as adjusted net tangible book value as of December 31, 2025 would have been $3.56 per share of our common stock. This represents an immediate increase in pro forma as adjusted net tangible book value of $3.31 per share of our common stock to our existing stockholder, BioVie, and immediate dilution of $7.44 per share of our common stock to new investors participating in this offering.

The following table illustrates this dilution per share of our common stock:

Assumed public offering price per share of our common stock				$	11.00
Historical net tangible book value per share of our common stock as of December 31, 2025	$	7,863.39
Decrease per share attributable to the issuance of shares to BioVie immediately prior to this offering	$	(7,863.14	)
As adjusted net tangible book value per share of our common stock as of December 31, 2025				$	0.25
Increase in pro forma as adjusted net tangible book value per share of our common stock attributable to new investors in this offering	$	3.31
Pro forma as adjusted net tangible book value per share of our common stock after this offering				$	3.56
Dilution per share of our common stock to new investors participating in this offering				$	7.44

After giving effect to the sale of our common stock in this offering at an assumed price of $11.00 per share of our common stock, assuming the underwriters’ over-allotment option to purchase additional shares of our common stock is exercised in full and after deducting the estimated underwriting discounts and commissions and other estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of December 31, 2025 would have been $3.89 per share of our common stock. This represents an immediate increase in pro forma as adjusted net tangible book value of $3.64 per share of our common stock to our existing stockholder, BioVie, and immediate dilution of $7.11 per share of our common stock to new investors participating in this offering.

We may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our equity holders.

The dilution information discussed above is illustrative only and will change based on the actual initial public offering price and other terms of this offering determined at pricing. A $1.00 increase in the assumed public offering price of $11.00 per share of our common stock would increase our pro forma as adjusted net tangible book value after this offering to $3.89 per share of our common stock and would decrease dilution to new investors by $0.67 per share of our common stock. An increase of 200,000 in the number of shares of our common stock we are offering would increase our pro forma as adjusted net tangible book value after this offering to $3.96 per share and would decrease dilution to new investors by $0.40 per share of our common stock, assuming the assumed public offering price per share remains the same, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. A decrease of 200,000 in the number of shares of our common stock we are offering would decrease our pro forma as adjusted net tangible book value after this offering to $3.15 per share of our common stock and would increase dilution to new investors by $0.41 per share of our common stock, assuming the assumed public offering price per share remains the same, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us.

The following table summarizes, on the pro forma as adjusted basis described above as of December 31, 2025, the differences between the number of shares of our common stock purchased from us, the total consideration and the price per share paid by our existing stockholder, BioVie, and by investors participating in this offering at an assumed initial public offering price of $11.00 per share of our common stock (the midpoint of the price range set forth on the cover page of this prospectus), before deducting the underwriting discount and estimated offering expenses payable by us.

	Shares Purchased					Total Consideration (In thousands)					Weighted- Average Price Per
	Number		Percent			Amount		Percent			Share
Existing stockholder, BioVie		3,181,818⁽¹⁾		63.6	%	$	—		—	%	$	—
Investors participating in this offering		1,818,282		36.4	%	$	20,000,000		100.0	%	$	11.00
Total		5,000,000		100.0	%	$	20,000,000		100.0	%

(1)

Immediately prior to the consummation of this offering, we will issue an aggregate of 3,181,718 shares of our common stock to BioVie pursuant to the separation agreement.

A $1.00 increase in the assumed initial public offering price of $11.00 per share of our common stock would increase total consideration paid by new investors by $1.7 million, assuming that the number of shares offered by us remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us. An increase of 200,000 in the number of shares of our common stock we are offering would increase total consideration paid by new investors by $2.0 million, assuming that the assumed initial public offering price remains the same, after deducting underwriting discounts and commissions and the estimated offering expenses payable by us.

The table above assumes no exercise of the underwriters’ over-allotment option in this offering. If the underwriters’ over-allotment option is exercised in full, the number of common shares held by new investors purchasing our common stock in this offering would be increased to approximately 40% of the total number of shares of our common stock outstanding after this offering, and the number of shares of our common stock held by existing stockholders would be reduced to approximately 60% of the total number of shares of our common stock outstanding after this offering.

To the extent that we issue additional shares of our common stock in the future, there will be future dilution to investors participating in this offering. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

BUSINESS

Overview

We are a clinical-stage company developing innovative drug therapies to treat debilitating and life-threatening liver disease through our investigational drug candidate BIV201 (continuous infusion terlipressin). BIV201 has been granted both FDA Fast Track designation status and FDA Orphan Drug Status, which designations provide certain advantages in the review process, but do not guarantee a faster development process, regulatory review or approval as compared to the conventional FDA review and approval process. BIV201 is being evaluated as a treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by MASLD hepatitis, and alcoholism. BIV201 is designed to be administered as a patented liquid formulation of terlipressin with patents issued, to date, in the U.S., Australia, China, Japan, Chile, and India, and with seven pending patent applications in the U.S. and other jurisdictions. Also, we own U.S. Patent No. 11,364,277, and European Patent No. EP3347032, which are directed to a method of treating ascites with BIV201, and we are pursuing additional patent coverage in the U.S., Japan, Europe, and China.

About Liver Cirrhosis

Individuals with cirrhosis are at high risk of developing complications which include ascites, variceal bleeding, hepatic encephalopathy, AKI, and bacterial infections, the development of which define decompensated cirrhosis, and the increased prevalence of cirrhosis is expected to result in increased incidence of cirrhosis complications. Ascites is a common complication of advanced liver cirrhosis involving the accumulation of large volumes of fluid in the abdomen, often exceeding five liters, due to liver and kidney dysfunction. Decompensated cirrhosis is an advanced stage of cirrhosis often associated with liver failure and is associated with worse survival rates (2-4 years and 20 - 57% mortality in one year) compared with compensated cirrhosis (10-15 years and 1 - 3% mortality in one year) . The majority of decompensated patients have ascites and are frequently hospitalized for complications. In 2014 approximately 100,000 individuals with cirrhosis and ascites were hospitalized in the United States with about 25,000 of those individuals being readmitted within 30 days. Assuming at least a continuing trend to double the prospective patient population per decade, as was seen from 2012 to 2018, the estimated target population is approximately 190,000 per year. Those with ascites and AKI experience higher readmission rates and have a poor prognosis. The development of AKI is strongly associated with mortality and can increase risk of death five-fold.

The Need for Therapy

A reduction in complications in decompensated patients could lead to a decrease in the risk of hospitalization, reducing health care burden and costs, and incre

Amendment: SEC Form S-1/A filed by OptiNose Inc.