CARSON CITY, Nev., March 04, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ:BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders, today announced the pricing of its best efforts public offering of 21,000,000 shares of its common stock (or pre-funded warrants ("Pre-funded Warrants") in lieu thereof) and warrants to purchase up to 10,500,000 shares of co ...

CARSON CITY, Nev., March 01, 2024 (GLOBE NEWSWIRE) -- Carson City, Nevada – March 1, 2024 – BioVie Inc. (NASDAQ:BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) in a best efforts public offering. All of the shares of common s ...

BioVie (NASDAQ:BIVI) stock is rocketing higher on Friday announed positive data from two clinical trials of NE3107.NE3107 is BioVie’s inhibitor of inflammatory activation of ERK and NFkB. These are both factors tied to Alzheimer’s and Parkinson’s diseases.The company’s Phase 3 of NE3107 in mild to moderate Alzheimer’s Disease patients suggests it may “realign physiological processes in patients consistent with decreased neurocognitive decline and diseases of aging.”As for its Phase 2a trial of Parkinson’s D ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Operating Expenses - Total operating expenses for the three months ended December 31, 2023, were approximately $8.8 million, a decrease of $2.7 million compared to $11.5 million for the same period in 2022[11] - Total operating expenses for the six months ended December 31, 2023, were approximately $19.7 million, a slight decrease from $20.3 million for the same period in 2022[13] Research and Development - Research and development expenses decreased by approximately $563,000 due to the completion of clinical trials, while selling, general and administrative expenses decreased by approximately $2.2 million, primarily from a decline in stock compensation expense[11] - The company received FDA guidance for the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis in June 2023[9] - BIV201 has been granted both FDA Fast Track designation and Orphan Drug status, indicating its potential significance in treating liver disease[8] - The company is finalizing protocol designs for the Phase 3 study of BIV201, which is administered as a patent-pending liquid formulation[9] Financial Position - As of December 31, 2023, the company had working capital of approximately $6.6 million and cash and cash equivalents totaling approximately $20.2 million[16] - The company reported an accumulated deficit of approximately $320.3 million as of December 31, 2023[16] - Management expressed uncertainty regarding the ability to obtain sufficient financing to fund continuing operations, raising substantial doubt about the company's ability to continue as a going concern[17] Other Income - Other income for the three months ended December 31, 2023, was approximately $380,000, compared to a net expense of $4.2 million for the same period in 2022, resulting in a net increase of approximately $4.6 million[12]

Financial Performance - Revenue increased by 15% year-over-year, driven by strong sales in the Asia-Pacific region [1]. - Net profit margin improved to 12%, up from 10% in the previous quarter [2]. - Operating expenses rose by 8%, primarily due to increased marketing and R&D investments [3]. Market Expansion - The company successfully entered two new markets in Europe, contributing to a 20% increase in international sales [4]. - A new distribution center was opened in South America to support regional growth [1]. - Strategic partnerships were formed with local retailers in Southeast Asia to enhance market penetration [2]. Product Development - Launched three new products in the tech segment, which accounted for 25% of total revenue [3]. - R&D investment increased by 10% to accelerate innovation and product differentiation [4]. - Customer feedback on the latest product line has been overwhelmingly positive, with a 95% satisfaction rate [1]. Operational Efficiency - Implemented a new supply chain management system, reducing delivery times by 15% [2]. - Automation initiatives in manufacturing led to a 10% reduction in production costs [3]. - Employee training programs were expanded, resulting in a 20% improvement in operational productivity [4]. Sustainability Initiatives - Achieved a 30% reduction in carbon emissions through the adoption of renewable energy sources [1]. - Introduced eco-friendly packaging for all product lines, reducing plastic usage by 25% [2]. - Partnered with environmental organizations to promote sustainable practices across the supply chain [3]. Corporate Governance - Appointed two new independent directors to the board, enhancing governance and oversight [4]. - Conducted a comprehensive review of corporate policies to ensure compliance with global standards [1]. - Increased transparency in financial reporting, earning recognition from industry watchdogs [2].

PART I [Business Overview](index=5&type=section&id=Item%201.%20Business) BioVie Inc. is a clinical-stage biopharmaceutical company developing innovative drug therapies for neurological and neurodegenerative disorders and advanced liver disease, with lead candidates NE3107 and BIV201 in clinical development stages - BioVie Inc. is a clinical-stage company developing drug therapies for neurological/neurodegenerative disorders and liver disease[15](index=15&type=chunk)[52](index=52&type=chunk)[513](index=513&type=chunk) - **NE3107**, acquired from NeurMedix, is a novel orally administered small molecule believed to inhibit inflammation-driven insulin resistance and inflammatory cascades, implicated in Alzheimer's Disease (AD) and Parkinson's Disease (PD)[16](index=16&type=chunk)[56](index=56&type=chunk)[522](index=522&type=chunk) - **BIV201** (continuous infusion terlipressin) is an Orphan Drug candidate with FDA Fast Track status, being evaluated for refractory ascites due to liver cirrhosis[59](index=59&type=chunk)[104](index=104&type=chunk)[524](index=524&type=chunk) [Neurodegenerative Disease Program](index=5&type=section&id=Neurodegenerative%20Disease%20Program) BioVie's neurodegenerative program focuses on NE3107 for Alzheimer's and Parkinson's diseases, with a Phase 3 AD study targeting Q4 2023 completion and a successful Phase 2 PD study showing motor control improvements - **NE3107** inhibits inflammatory activation of ERK and NFkB, which are drivers of Alzheimer's disease (AD) and Parkinson's disease (PD)[53](index=53&type=chunk)[81](index=81&type=chunk) - The Phase 3 study for **NE3107** in mild to moderate AD (NCT04669028) is fully enrolled and targeting primary completion in Q4 2023[54](index=54&type=chunk)[62](index=62&type=chunk)[533](index=533&type=chunk) - The Phase 2 study of **NE3107** in Parkinson's disease (NCT05083260) met its primary (safety and drug-drug interaction) and secondary (promotoric activity) objectives, showing greater motor control improvements in patients, especially those under 70[55](index=55&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk)[98](index=98&type=chunk)[534](index=534&type=chunk) - Exploratory Phase 2 AD data showed **NE3107** enhanced cognition, reduced inflammation (TNF-α), decreased CSF phospho-tau levels, and improved neuronal health, with no drug-related adverse events[37](index=37&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk) [Liver Disease Program](index=6&type=section&id=Liver%20Disease%20Program) BioVie's liver disease program centers on BIV201 for refractory ascites, a condition with no FDA-approved treatments, showing significant fluid reduction in a Phase 2b study and holding Orphan Drug and Fast Track designations - **BIV201** (continuous infusion terlipressin) has FDA Fast Track status and Orphan Drug designation for refractory ascites due to liver cirrhosis, a condition with high mortality and no FDA-approved drugs[59](index=59&type=chunk)[60](index=60&type=chunk)[97](index=97&type=chunk)[104](index=104&type=chunk)[111](index=111&type=chunk)[524](index=524&type=chunk) - Interim data from the Phase 2b study showed **BIV201** plus SOC resulted in a **34% reduction** in ascites fluid during treatment, significantly different from SOC only, with patients completing **BIV201** treatment experiencing a **53% reduction**[38](index=38&type=chunk)[107](index=107&type=chunk) - The company is developing a proprietary room-temperature stable liquid formulation of terlipressin in a pre-filled syringe, offering improved convenience and potential for up to two years of stability, differentiating it from existing refrigerated products[110](index=110&type=chunk) - The **BIV201** program aims to alleviate portal hypertension and correct splanchnic vasodilation to reduce salt and water retention, thereby halting ascites fluid generation[70](index=70&type=chunk) [Intellectual Property](index=13&type=section&id=Intellectual%20Property) BioVie protects its drug candidates BIV201 and NE3107 through patents, trade secrets, and non-disclosure agreements, with BIV201 holding Orphan Drug Designations and NE3107 protected by 15 issued U.S. patents - BioVie relies on patents, trade secrets, and non-disclosure agreements to protect its products[73](index=73&type=chunk)[214](index=214&type=chunk) - **BIV201** has U.S. Orphan Drug Designations for hepatorenal syndrome (Nov 2018) and ascites (Sept 2016)[74](index=74&type=chunk)[164](index=164&type=chunk) - The company has filed a PCT application for **BIV201**'s novel liquid formulations and is seeking patent protection in the U.S., Europe, China, Japan, and other jurisdictions[74](index=74&type=chunk)[110](index=110&type=chunk)[217](index=217&type=chunk) - As of August 15, 2023, **NE3107** and related compounds are protected by **15 issued U.S. patents**, 6 pending U.S. patent applications, 1 pending U.S. PCT application, and 6 issued foreign patents[76](index=76&type=chunk)[217](index=217&type=chunk) [Government Regulation](index=14&type=section&id=Government%20Regulation) BioVie's drug candidates are subject to extensive FDA regulation covering R&D, clinical trials, and approval, with BIV201 benefiting from expedited programs like Orphan Drug Designation and Fast Track status - Drug development is extensively regulated by the FDA in the U.S. and comparable foreign authorities, covering R&D, manufacturing, labeling, approval, and marketing[203](index=203&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk) - The U.S. drug development process includes preclinical tests, IND application, three phases of human clinical trials (Phase 1, 2, 3), NDA/BLA submission, FDA inspection of manufacturing facilities, and review/approval[77](index=77&type=chunk)[114](index=114&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[266](index=266&type=chunk) - **BIV201** has received Orphan Drug Designation, which grants **7 years of market exclusivity** upon first FDA approval for the designated rare disease, under specific conditions[136](index=136&type=chunk)[137](index=137&type=chunk) - The FDA's Fast Track program, also granted to **BIV201**, expedites review for drugs treating serious conditions with unmet medical needs, potentially allowing rolling submissions[138](index=138&type=chunk) - Post-approval, products are subject to ongoing FDA regulation, including adverse event reporting, updated safety information, and compliance with cGMP for manufacturing[143](index=143&type=chunk)[144](index=144&type=chunk) [Employees](index=18&type=section&id=Employees) BioVie Inc. has 18 full-time employees, including its executive officers, and supplements its product development activities with a team of experienced scientific, medical, and regulatory consultants - The Company has **18 full-time employees**, including its CEO, CFO, and Chief Medical Officer[142](index=142&type=chunk) - BioVie relies on a team of highly experienced scientific, medical, and regulatory consultants for product development[142](index=142&type=chunk) [Risk Factors](index=19&type=section&id=Item%201A.%20Risk%20Factors) BioVie faces significant risks as a development-stage biopharmaceutical company, including lack of approved products, continuous losses, dependence on successful clinical trials and regulatory approvals, need for additional capital, competition, reliance on third parties, and stock volatility - The company has no products approved for commercial sale, has not generated revenue, and may never achieve profitability, raising substantial doubt about its ability to continue as a going concern[150](index=150&type=chunk)[151](index=151&type=chunk)[155](index=155&type=chunk)[168](index=168&type=chunk) - Significant additional capital will be required to fund operations, and there is no assurance that sufficient financing will be obtained on acceptable terms, which could force delays, reductions, or termination of R&D programs[167](index=167&type=chunk)[170](index=170&type=chunk)[172](index=172&type=chunk) - Drug development is a time-consuming and uncertain process; product candidates may fail clinical trials, not receive regulatory approval, or be less effective/more expensive than competitors, leading to potential cessation of operations[174](index=174&type=chunk)[176](index=176&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk) - Reliance on third parties (CROs, CMOs) for clinical trials and manufacturing poses risks, including failure to meet deadlines, non-compliance with regulations (cGCPs, cGMP), and potential supply shortages[185](index=185&type=chunk)[186](index=186&type=chunk)[189](index=189&type=chunk)[193](index=193&type=chunk)[194](index=194&type=chunk)[196](index=196&type=chunk) - Future equity offerings or issuance of shares upon exercise of options/warrants could result in substantial dilution for existing stockholders[243](index=243&type=chunk)[244](index=244&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk)[249](index=249&type=chunk) [Unresolved Staff Comments](index=35&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[6](index=6&type=chunk) [Properties](index=35&type=section&id=Item%202.%20Properties) BioVie Inc. maintains its headquarters in Carson City, Nevada, with an annual rent of **$2,200**, and a San Diego office under a 38-month lease with a monthly base rate of **$4,175**, subject to annual **3%** increases - The company's headquarters in Carson City, NV, has an annual rent of **$2,200** for a one-year term starting October 1, 2022[7](index=7&type=chunk)[85](index=85&type=chunk)[628](index=628&type=chunk) - The San Diego office relocated on February 26, 2022, with a 38-month lease commencing March 1, 2022, and a monthly base rate of **$4,175** that began June 1, 2022, with annual **3%** increases[7](index=7&type=chunk)[85](index=85&type=chunk)[315](index=315&type=chunk) [Legal Proceedings](index=35&type=section&id=Item%203.%20Legal%20Proceedings) To the company's knowledge, neither BioVie Inc. nor its officers or directors are party to any material legal proceedings or litigation, nor are there any judgments against them - Neither the Company nor its officers or directors are party to any material legal proceeding or litigation[8](index=8&type=chunk) - There are no judgments against the company or its officers/directors, and none have been convicted of securities-related felonies or misdemeanors[8](index=8&type=chunk) [Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) BioVie Inc. has no mine safety disclosures to report - No mine safety disclosures are applicable to the company[9](index=9&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=36&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) All sales of unregistered securities during FY2023 were previously disclosed in Form 10-Q or 8-K reports, and the company made no repurchases of Common Stock during this period - All sales of unregistered securities during the year ended June 30, 2023, were previously disclosed in Quarterly Reports on Form 10-Q or Current Reports on Form 8-K[12](index=12&type=chunk) - There were no issuer repurchases of Common Stock during the year ended June 30, 2023[13](index=13&type=chunk) [Reserved](index=36&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - Item 6 is reserved[14](index=14&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) BioVie Inc. is a clinical-stage company with no current revenues, reporting a net loss of **$50.3 million** in FY2023 due to increased clinical activities, and faces substantial doubt about its going concern ability due to an accumulated deficit of **$301 million** and reliance on future financing - BioVie Inc. is a clinical-stage company developing drug therapies for neurological/neurodegenerative disorders and liver disease, with no revenues generated to date and none expected in the foreseeable future[15](index=15&type=chunk)[45](index=45&type=chunk)[513](index=513&type=chunk)[538](index=538&type=chunk) Net Loss and Operating Expenses (Year Ended June 30) | Metric | 2023 (approx.) | 2022 (approx.) | Change (YoY) | | :----- | :------------- | :------------- | :----------- | | Net Loss | $(50.3) million | $(26.1) million | $(24.2) million increase | | Total Operating Expenses | $45.1 million | $27.3 million | $17.8 million increase | - The increase in net loss was primarily due to increased clinical activities (**$16.0 million**), administrative expenses (**$1.8 million**), and a **$6.3 million** increase in other expenses, mainly from a change in fair value of derivative liabilities (**$4.7 million**)[20](index=20&type=chunk)[21](index=21&type=chunk)[42](index=42&type=chunk) Capital Resources and Liquidity (as of June 30, 2023) | Metric | Amount (approx.) | | :----- | :--------------- | | Working Capital | $19.5 million | | Cash, Cash Equivalents & U.S. Treasury Bills | $33.9 million | | Stockholders' Equity | $15.3 million | | Accumulated Deficit | $(301) million | - The company sold approximately **7.5 million** shares of Common Stock under its Controlled Equity Offering Sales Agreement for total net proceeds of approximately **$49.5 million** during FY2023[44](index=44&type=chunk)[599](index=599&type=chunk) - Management expects future funding sources to include equity sales, loans, or strategic transactions, but there is no assurance of obtaining sufficient financing, raising substantial doubt about the company's ability to continue as a going concern[45](index=45&type=chunk)[46](index=46&type=chunk)[539](index=539&type=chunk)[541](index=541&type=chunk) [Results of Operations](index=37&type=section&id=Results%20of%20Operations) BioVie's FY2023 financial results show a net loss increase to **$50.3 million** from **$26.1 million** in FY2022, driven by a **$17.8 million** rise in operating expenses, primarily from R&D activities and a **$6.4 million** increase in other expenses Net Loss and Operating Expenses (Year Ended June 30) | Metric | 2023 (approx.) | 2022 (approx.) | Change (YoY) | | :----- | :------------- | :------------- | :----------- | | Net Loss | $(50.3) million | $(26.1) million | $(24.2) million increase | | Total Operating Expenses | $45.1 million | $27.3 million | $17.8 million increase | Expense Breakdown (Year Ended June 30) | Expense Category | 2023 (approx.) | 2022 (approx.) | Change (YoY) | | :--------------- | :------------- | :------------- | :----------- | | Research and Development | $33.3 million | $17.3 million | $16.0 million increase | | Selling, General and Administrative | $11.6 million | $9.8 million | $1.8 million increase | | Other Expense (Income), Net | $5.2 million | $(1.2) million | $6.4 million increase | - The **$16.0 million** increase in R&D expenses was mainly due to increased clinical activities for Neuroscience **NE3107** studies, including the completion of the Parkinson's Phase 2 study and full enrollment of the Alzheimer's Phase 3 study[22](index=22&type=chunk)[40](index=40&type=chunk) - The **$1.8 million** increase in SG&A expenses was primarily attributed to increased stock compensation expense for the board of directors, legal, investor relations, and other professional fees[41](index=41&type=chunk) - The **$6.4 million** increase in net other expenses was driven by a **$2.1 million** increase in interest expense and a **$4.7 million** change in the fair value of derivative liabilities, partially offset by increased interest income[42](index=42&type=chunk) [Capital Resources and Liquidity](index=38&type=section&id=Capital%20Resources%20and%20Liquidity) As of June 30, 2023, BioVie reported **$19.5 million** in working capital and **$33.9 million** in cash, cash equivalents, and U.S. Treasury bills, but an accumulated deficit of **$301 million**, with future operations contingent on securing additional financing, raising substantial doubt about its going concern ability Capital Resources (as of June 30, 2023) | Metric | Amount (approx.) | | :----- | :--------------- | | Working Capital | $19.5 million | | Cash, Cash Equivalents & U.S. Treasury Bills | $33.9 million | | Stockholders' Equity | $15.3 million | | Accumulated Deficit | $(301) million | - The company has not generated any revenue and does not expect to in the foreseeable future, making future operations dependent on successful development and commercialization efforts, and securing additional financing[45](index=45&type=chunk)[538](index=538&type=chunk) - During FY2023, BioVie sold approximately **7.5 million** shares of Common Stock, generating **$49.5 million** in net proceeds[44](index=44&type=chunk)[599](index=599&type=chunk) - Management's plans for future funding include equity sales, loans, or strategic transactions, but the uncertainty of obtaining sufficient financing raises substantial doubt about the company's ability to continue as a going concern[45](index=45&type=chunk)[46](index=46&type=chunk)[539](index=539&type=chunk)[541](index=541&type=chunk) [Recently Issued Accounting Pronouncement](index=38&type=section&id=Recently%20Issued%20Accounting%20Pronouncement) The company does not expect a material impact from the adoption of ASU No. 2016-13, which replaces the incurred loss impairment methodology with expected credit losses, with its effective date for smaller reporting companies deferred to fiscal years beginning after December 15, 2022 - ASU No. 2016-13, which replaces the incurred loss impairment methodology with expected credit losses, is not expected to have a material impact on the company's financial statements[47](index=47&type=chunk)[552](index=552&type=chunk) - The effective date for smaller reporting companies for ASU 2016-13 was deferred for fiscal years beginning after December 15, 2022[47](index=47&type=chunk)[552](index=552&type=chunk) [Off-Balance Sheet Arrangements](index=38&type=section&id=Off-Balance%20Sheet%20Arrangements) BioVie Inc. has no off-balance sheet arrangements that are material or reasonably likely to have a current or future significant effect on its financial condition, revenues, expenses, results of operations, liquidity, capital expenditures, or capital resources - The company has no off-balance sheet arrangements that are material or likely to significantly affect its financial condition or results[48](index=48&type=chunk) [Critical Accounting Policies and Estimates](index=39&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) BioVie's critical accounting policies involve significant management estimates for clinical accruals, share-based compensation, derivatives, leases, and intangible asset valuation, while monitoring credit risk in cash and accounting for U.S. Treasury Bills as available-for-sale investments at fair value - The preparation of financial statements requires management to make estimates and assumptions affecting reported amounts, including for clinical accruals, share-based compensation, derivatives, leases, and impairment of intangible assets and goodwill[526](index=526&type=chunk)[550](index=550&type=chunk) - Cash and cash equivalents include cash deposits and money market funds, with investments in U.S. Treasury Bills (maturities of three months or less) also classified here[50](index=50&type=chunk)[527](index=527&type=chunk) - Investments in U.S. Treasury Bills with maturities greater than three months are accounted for as available-for-sale and recorded at fair value, with unrealized gains included in other comprehensive income[39](index=39&type=chunk)[528](index=528&type=chunk)[646](index=646&type=chunk) - The company monitors the financial stability of institutions holding cash in excess of federally insured levels, acknowledging heightened uncertainties in financial markets could impact access to cash or financing[277](index=277&type=chunk)[645](index=645&type=chunk) - Operating leases are recognized as right-of-use assets and lease liabilities based on the present value of future minimum lease payments, using an incremental borrowing rate[530](index=530&type=chunk)[638](index=638&type=chunk) - Fair values of financial instruments are determined using a hierarchy (Level 1, 2, 3) that prioritizes observable inputs[278](index=278&type=chunk)[570](index=570&type=chunk)[571](index=571&type=chunk)[572](index=572&type=chunk)[639](index=639&type=chunk)[649](index=649&type=chunk)[650](index=650&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) BioVie Inc. has no material market risk disclosures to report - No quantitative and qualitative disclosures about market risk are applicable[658](index=658&type=chunk) [Financial Statements and Supplementary Data](index=40&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The financial statements and supplementary data are incorporated by reference from Item 15 of this report - Financial information is indexed under Item 15 and incorporated by reference[659](index=659&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=40&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) BioVie Inc. has no changes in or disagreements with accountants on accounting and financial disclosure to report - No changes in or disagreements with accountants on accounting and financial disclosures are applicable[659](index=659&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%209A.%20Controls%20and%20Procedures) BioVie's management, including the CEO and CFO, concluded that both disclosure controls and internal control over financial reporting were effective as of June 30, 2023, based on the COSO 2013 Framework, with no material changes during the quarter - Management concluded that disclosure controls and procedures were effective as of June 30, 2023[651](index=651&type=chunk) - Management concluded that internal control over financial reporting was effective as of June 30, 2023, based on the COSO 2013 Framework[660](index=660&type=chunk) - There were no material changes in internal controls over financial reporting during the quarter ended June 30, 2023[661](index=661&type=chunk) [Other Information](index=41&type=section&id=Item%209B.%20Other%20Information) BioVie Inc. has no other information to report under this item - No other information is applicable[662](index=662&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=41&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) BioVie Inc. has no disclosures regarding foreign jurisdictions that prevent inspections - No disclosures regarding foreign jurisdictions that prevent inspections are applicable[368](index=368&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=42&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) BioVie Inc.'s Board of Directors comprises seven members, with six independent, and has established Audit, Compensation, and Nominating and Corporate Governance committees, all composed of independent directors, while also adopting a Code of Conduct and Ethics and an anti-hedging policy Board of Directors and Executive Officers (as of August 9, 2023) | Name | Age | Director Since | Position | | :--- | :-- | :------------- | :------- | | Cuong Do | 57 | 2016 | CEO & President and Director | | Joanne Wendy Kim | 68 | — | CFO | | Joseph M. Palumbo, MD | 63 | — | Chief Medical Officer | | Jim Lang | 58 | 2016 | Chairman of the Board | | Michael Sherman | 64 | 2017 | Director | | Richard J. Berman | 81 | 2019 | Director | | Steve Gorlin | 86 | 2020 | Director | | Robert Hariri, MD, PhD | 64 | 2020 | Director | | Sigmund Rogich | 79 | 2020 | Director | - Six of the seven Board members qualify as 'independent' under Nasdaq listing standards[396](index=396&type=chunk) - The Board has three standing committees: Audit, Compensation, and Nominating and Corporate Governance, all composed solely of independent directors[388](index=388&type=chunk) - The company has adopted a Code of Conduct and Ethics and an insider trading policy that includes anti-hedging provisions[410](index=410&type=chunk)[411](index=411&type=chunk)[415](index=415&type=chunk) [Executive Compensation](index=48&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for BioVie's named executive officers includes salary, bonus, and equity awards, with CEO Cuong Do's total compensation at **$2.34 million** in FY2023, and director compensation primarily consisting of equity awards under the 2019 Omnibus Equity Incentive Plan Summary Compensation Table (Year Ended June 30) | Name and Principal Position | Year | Salary | Bonus | Stock Awards | Option Awards | Total | | :-------------------------- | :--- | :----- | :---- | :----------- | :------------ | :---- | | Cuong Do, CEO & President | 2023 | $618,000 | $463,500 | $734,668 | $521,500 | $2,337,668 | | | 2022 | $300,000 | $400,000 | $210,439 | $3,632,382 | $4,542,821 | | Joanne Wendy Kim, CFO | 2023 | $246,750 | $150,625 | $242,499 | $582,343 | $723,874 | | | 2022 | $235,000 | $127,656 | — | $84,000 | $944,999 | | Joseph Palumbo, CMO | 2023 | $525,000 | $197,000 | $242,499 | $126,000 | $1,090,499 | | | 2022 | $333,333 | $239,167 | — | $244,465 | $816,965 | Compensation Actually Paid (CAP) vs. Summary Compensation Table (SCT) Total (Year Ended June 30) | Metric | 2023 | 2022 | | :----- | :--- | :--- | | SCT Total for PEO | $2,337,668 | $4,542,821 | | Compensation Actually Paid to PEO | $3,434,517 | $916,050 | | Average SCT Total for Non-PEO NEOs | $1,185,289 | $605,653 | | Average Compensation Actually Paid to Non-PEO NEOs | $1,185,289 | $605,653 | - As of June 30, 2023, named executive officers held stock options to purchase **1,371,729 shares** (aggregate grant date fair value of ~**$5.4 million**) and **351,386 RSUs** (market value of ~**$1.5 million**)[427](index=427&type=chunk) - Non-employee directors received compensation primarily in the form of equity awards, with FY2023 annual compensation including **155,636 RSUs** (grant date market value **$952,492**) or stock options for **195,000 shares** (grant date fair value **$791,700**)[431](index=431&type=chunk) Equity Compensation Plan Information (as of June 30, 2023) | Plan Category | Number of securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance | | :------------ | :---------------------------------------------------------------------------------------- | :---------------------------------------------------------- | :----------------------------------------------------------- | | Approved by security holders | 4,530,121 | $6.71 | 2,269,952 | | Not approved by security holders | — | — | — | | Total | 4,530,121 | $6.71 | 2,269,952 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=56&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of August 9, 2023, Acuitas Group Holdings, LLC, owned **69.1%** of BioVie's common stock, making it the majority stockholder, with directors and executive officers as a group owning **4.8%**, a concentration that could significantly influence company affairs Beneficial Ownership (as of August 9, 2023) | Name and Address of Beneficial Owner | Beneficial Ownership | Percentage of Beneficial Ownership | | :----------------------------------- | :------------------- | :------------------------------- | | Acuitas Group Holdings | 30,503,938 | 69.1% | | All directors and executive officers as a group | 1,784,243 | 4.8% | - Acuitas Group Holdings, LLC, **100%** owned by Terren Peizer, is the majority stockholder, holding **69.1%** of outstanding common stock[346](index=346&type=chunk)[455](index=455&type=chunk) - The concentration of ownership by directors, executive officers, and affiliates (**64.0%** as of August 9, 2023) could significantly influence company management and stockholder approval matters[248](index=248&type=chunk)[251](index=251&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=58&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) BioVie Inc. engages in related party transactions, including a Securities Purchase Agreement with majority stockholder Acuitas Group Holdings, LLC, for common stock and warrants, with all such transactions subject to review and approval by the audit committee or Board of Directors - The company entered into a Securities Purchase Agreement with Acuitas Group Holdings, LLC (a related party and majority stockholder) on July 15, 2022[467](index=467&type=chunk)[582](index=582&type=chunk) - Under this agreement, Acuitas purchased **3,636,364 shares** of Class A Common Stock at **$1.65 per share** and warrants to purchase **7,272,728 shares** at an exercise price of **$1.82**, for an aggregate purchase price of **$6 million**[467](index=467&type=chunk)[582](index=582&type=chunk) - All related party transactions are approved by either the audit committee or the Board of Directors, with policies and procedures in place to ensure proper review[458](index=458&type=chunk)[474](index=474&type=chunk) [Principal Accountant Fees and Services](index=59&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) For FY2023 and FY2022, BioVie Inc. incurred **$317,772** and **$223,102** in audit fees, respectively, from its independent registered public accounting firm, with the Audit Committee responsible for appointing and overseeing auditors and pre-approving all services Principal Accountant Fees (Year Ended June 30) | Fee Category | 2023 | 2022 | | :----------- | :--- | :--- | | Audit Fees | $317,772 | $223,102 | | Audit-Related Fees | — | — | | Tax Fees | — | — | | All Other Fees | — | — | | Total | $317,772 | $223,102 | - The Audit Committee is responsible for appointing, setting compensation, and overseeing the work of the independent registered public accounting firm[469](index=469&type=chunk) - The Audit Committee has a policy to pre-approve all audit and permissible non-audit services, with delegation authority to one or more members[469](index=469&type=chunk)[478](index=478&type=chunk)[479](index=479&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=60&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules, including audited financial statements for FY2023 and FY2022 by EisnerAmper LLP, which present the company's financial position, operations, equity changes, and cash flows in accordance with GAAP, while also highlighting a going concern uncertainty - The financial statements for the years ended June 30, 2023 and 2022 are filed as part of this report[489](index=489&type=chunk) - EisnerAmper LLP served as the independent registered public accounting firm and issued an unqualified opinion on the financial statements[486](index=486&type=chunk)[504](index=504&type=chunk)[517](index=517&type=chunk) - The financial statements were prepared assuming the company will continue as a going concern, but recurring losses and negative cash flows raise substantial doubt about this ability[514](index=514&type=chunk)[538](index=538&type=chunk)[541](index=541&type=chunk) [Financial Statements](index=63&type=section&id=Financial%20Statements) The financial statements, including Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, reflect a net loss of **$50.3 million** in FY2023 and an accumulated deficit of **$301 million**, detailing assets, liabilities, equity, critical accounting policies, and related party transactions - The financial statements include Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Changes in Stockholders' Equity, Statements of Cash Flows, and Notes to Financial Statements[484](index=484&type=chunk) Balance Sheet Highlights (as of June 30) | Metric | 2023 | 2022 | | :----- | :--- | :--- | | Total Assets | $35,104,730 | $20,114,594 | | Total Liabilities | $19,764,444 | $16,443,659 | | Total Stockholders' Equity | $15,340,286 | $3,670,935 | Statements of Operations and Comprehensive Loss Highlights (Year Ended June 30) | Metric | 2023 | 2022 | | :----- | :--- | :--- | | Net Loss | $(50,255,815) | $(26,084,468) | | Basic Net Loss Per Common Share | $(1.55) | $(1.06) | | Diluted Net Loss Per Common Share | $(1.55) | $(1.06) | | Weighted Average Common Shares Outstanding (Basic & Diluted) | 32,483,489 | 24,662,557 | Statements of Cash Flows Highlights (Year Ended June 30) | Cash Flow Activity | 2023 | 2022 | | :----------------- | :--- | :--- | | Net cash used in operating activities | $(40,252,881) | $(18,990,850) | | Net cash used in investing activities | $(14,301,135) | — | | Net cash provided by financing activities | $55,373,183 | $33,120,924 | | Net increase in cash and cash equivalents | $819,167 | $14,130,074 | - The company's accumulated deficit increased to approximately **$301 million** as of June 30, 2023[43](index=43&type=chunk)[506](index=506&type=chunk)[538](index=538&type=chunk)

PART I – FINANCIAL INFORMATION This section covers BioVie Inc.'s unaudited condensed financial statements, management's discussion, market risks, and internal controls [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for BioVie Inc., including balance sheets, statements of operations, cash flows, and changes in stockholders' equity, along with detailed notes explaining significant accounting policies, financial instruments, and equity transactions for the periods ended March 31, 2023 and 2022 [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets%20at%20March%2031%2C%202023%20(unaudited)%20and%20June%2030%2C%202022) This section details BioVie Inc.'s financial position, including assets, liabilities, and equity, at March 31, 2023, and June 30, 2022 | Metric | March 31, 2023 | June 30, 2022 | | :-------------------------- | :------------- | :------------ | | Cash and cash equivalents | $31,276,197 | $18,641,716 | | Investments in U.S. T-Bills | $12,521,448 | $- | | Total current assets | $44,047,435 | $18,779,595 | | Total Assets | $45,182,696 | $20,114,594 | | Total current liabilities | $16,004,339 | $4,169,174 | | Total Liabilities | $23,464,436 | $16,443,659 | | Total Stockholders' Equity | $21,718,260 | $3,670,935 | [Condensed Statements of Operations and Other Comprehensive Income](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20other%20comprehensive%20income%20(unaudited)%20-%20for%20the%20three%20months%20and%20nine%20months%20ended%20March%2031%2C%202023%20and%202022) This section details BioVie Inc.'s financial performance, including expenses and net loss, for the three and nine months ended March 31, 2023 and 2022 | Metric (Unaudited) | 3 Months Ended Mar 31, 2023 | 3 Months Ended Mar 31, 2022 | 9 Months Ended Mar 31, 2023 | 9 Months Ended Mar 31, 2022 | | :----------------------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development expenses | $11,196,835 | $3,577,142 | $24,999,665 | $11,385,586 | | Selling, general and administrative expenses | $2,520,330 | $2,114,348 | $8,931,957 | $6,403,508 | | Total operating expenses | $13,774,509 | $5,748,834 | $34,103,655 | $17,961,126 | | Change in fair value of derivative liabilities | $366,093 | $386,450 | $4,154,645 | $(1,168,804) | | Interest expense | $1,082,762 | $918,633 | $3,192,631 | $1,236,010 | | Net Loss | $(15,041,163) | $(7,040,644) | $(41,143,876) | $(17,995,711) | | Net Loss Per Common Share (Basic & Diluted) | $(0.43) | $(0.28) | $(1.32) | $(0.73) | [Condensed Statements of Cash Flows](index=5&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20(unaudited)%20-%20for%20the%20nine%20months%20ended%20March%2031%2C%202023%20and%202022) This section details BioVie Inc.'s cash flows from operating, investing, and financing activities for the nine months ended March 31, 2023 and 2022 | Cash Flow Activity (9 Months Ended Mar 31) | 2023 | 2022 | | :----------------------------------------- | :------------ | :------------ | | Net cash used in operating activities | $(28,965,321) | $(13,125,753) | | Net cash used in investing activities | $(12,504,943) | $- |\n| Net cash provided by financing activities | $54,104,745 | $33,120,924 | | Net increase in cash and cash equivalents | $12,634,481 | $19,995,171 | | Cash and cash equivalents, end of period | $31,276,197 | $24,506,813 | - Net proceeds from issuance of common stock significantly increased to **$48.2 million** in 2023 from **$18.5 million** in 2022, contributing to financing activities[107](index=107&type=chunk) [Condensed Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(unaudited)%20-%20for%20the%20periods%20from%20July%201%2C%202021%20through%20March%2031%2C%202022%20and%20July%201%2C%202022%20through%20March%2031%2C%202023) This section details changes in BioVie Inc.'s stockholders' equity, including common stock and accumulated deficit, for periods ended March 31, 2023 and 2022 | Metric (Unaudited) | June 30, 2022 | March 31, 2023 | | :----------------------------------------------- | :------------ | :------------- |\n| Common Stock Shares | 24,984,083 | 36,153,911 | | Additional Paid in Capital | $254,638,329 | $313,811,910 | | Accumulated Deficit | $(250,969,890)| $(292,113,766) |\n| Total Stockholders' Equity | $3,670,935 | $21,718,260 | - Proceeds from common stock issuance (net of costs) totaled approximately **$9.77 million** for the period July 1, 2022 - March 31, 2023, and **$32.52 million** for the period December 31, 2022 - March 31, 2023[110](index=110&type=chunk)[130](index=130&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) These notes provide detailed explanations of the company's business, liquidity challenges, significant accounting policies, and specific financial instruments and transactions, including related party dealings, debt, equity, and fair value measurements [Note 1. Background Information](index=9&type=section&id=1.%20Background%20Information) This note provides an overview of BioVie Inc.'s clinical-stage drug development focus and key pipeline candidates like NE3107 and BIV201 - BioVie Inc. is a clinical-stage company developing drug therapies for neurological, neuro-degenerative disorders, and liver disease[82](index=82&type=chunk)[133](index=133&type=chunk) - NE3107, an orally administered small molecule, is being evaluated in a **Phase 3 study** for mild to moderate Alzheimer's Disease (targeting primary completion in **Q4 2023**) and has completed a **Phase 2 study** for Parkinson's Disease, meeting safety and drug-drug interaction objectives[42](index=42&type=chunk)[113](index=113&type=chunk)[152](index=152&type=chunk) - BIV201, an Orphan drug candidate for refractory ascites, showed a **34% reduction** in ascites fluid in a paused **Phase 2b study**, with overall treatment appearing well tolerated[25](index=25&type=chunk)[114](index=114&type=chunk) [Note 2. Liquidity](index=10&type=section&id=2.%20Liquidity) This note addresses BioVie Inc.'s liquidity challenges, accumulated deficit, and dependence on future financing to continue operations - The Company has an accumulated deficit of approximately **$292 million** as of March 31, 2023, and has not generated any revenue to date, raising substantial doubt about its ability to continue as a going concern[136](index=136&type=chunk)[137](index=137&type=chunk) | Metric (March 31, 2023) | Amount | | :---------------------- | :------------ | | Working Capital | $28.0 million | | Cash & US Treasury Bills| $43.8 million | | Stockholders' Equity | $21.7 million | - Future operations are dependent on securing additional financing through equity sales, loans, or other strategic transactions[155](index=155&type=chunk)[240](index=240&type=chunk) [Note 3. Significant Accounting Policies](index=10&type=section&id=3.%20Significant%20Accounting%20Policies) This note outlines BioVie Inc.'s accounting principles, including interim financial statement preparation and net loss per share calculation - Interim financial statements are prepared in accordance with U.S. GAAP for interim financial information and Form 10-Q instructions[156](index=156&type=chunk) - Basic and diluted net loss per common share are calculated by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding, with anti-dilutive instruments excluded[157](index=157&type=chunk) - No recent Accounting Standards Updates (ASUs) are expected to have a material impact on the company's financial statements[158](index=158&type=chunk) [Note 4. Investments in U.S. Treasury Bills available for sale](index=11&type=section&id=4.%20Investments%20in%20U.S.%20Treasury%20Bills%20available%20for%20sale) This note details BioVie Inc.'s investments in U.S. Treasury Bills, classified as available-for-sale and recorded at fair value | Metric (March 31, 2023) | Amount | | :---------------------- | :------------ | | Amortized Cost Basis | $12,504,943 | | Gross Unrealized Gain | $16,505 | | Fair Value | $12,521,448 | - Investments in U.S. Treasury Bills with maturities greater than **3 months** are classified as available-for-sale and recorded at fair value, with unrealized gains included in other comprehensive income[161](index=161&type=chunk) [Note 5. Intangible Assets](index=12&type=section&id=5.%20Intangible%20Assets) This note describes BioVie Inc.'s intangible assets, primarily intellectual property, and their associated amortization expenses | Metric (Intellectual Property) | March 31, 2023 | June 30, 2022 | | :----------------------------- | :------------- | :------------ | | Intellectual Property | $2,293,770 | $2,293,770 | | Less Accumulated Amortization | $(1,599,331) | $(1,427,298) | | Intellectual Property, Net | $694,439 | $866,472 | | Amortization Expense | 3 Months Ended Mar 31, 2023 | 9 Months Ended Mar 31, 2023 | | :------------------- | :-------------------------- | :-------------------------- | | Amount | $57,344 | $172,033 | [Note 6. Related Party Transactions](index=13&type=section&id=6.%20Related%20Party%20Transactions) This note details BioVie Inc.'s transactions with related parties, including asset acquisitions and private placements with major stockholders - Acquired biopharmaceutical assets, including NE3107, from NeurMedix, Inc., a related party, in June 2021[42](index=42&type=chunk)[113](index=113&type=chunk)[166](index=166&type=chunk) - In August 2022, the Company received approximately **$5.9 million** in net proceeds from a private placement with Acuitas Group Holdings, LLC (majority stockholder), involving the issuance of **3,636,364 common shares** and warrants to purchase **7,272,728 shares**[142](index=142&type=chunk) - The company may be obligated to deliver contingent stock consideration of **up to 18 million shares** to NeurMedix upon achievement of certain clinical, regulatory, and commercial milestones[1](index=1&type=chunk) [Note 7. Other Liabilities](index=13&type=section&id=7.%20Other%20Liabilities) This note explains BioVie Inc.'s other liabilities, including the current portion and the impact of a retention bonus arrangement | Metric (Other Liabilities) | March 31, 2023 | June 30, 2022 | | :------------------------- | :------------- | :------------ | | Current portion | $193,542 | $1,304,925 | - The decrease in current portion of other liabilities is due to ongoing monthly installments of a **$1,161,000** retention bonus arrangement recognized in August 2021[193](index=193&type=chunk) [Note 8. Notes Payable](index=13&type=section&id=8.%20Notes%20Payable) This note details BioVie Inc.'s loan agreement, interest rates, maturity, and conversion options for its notes payable - The Company entered into a Loan Agreement with Avenue for **up to $20 million** in growth capital, with **$15 million** funded (Tranche 1)[2](index=2&type=chunk) - The Loan bears interest at an annual rate equal to the greater of (a) **7.00%** plus the prime rate (**8.0%** at March 31, 2023) or (b) **10.75%**, and matures on December 1, 2024[2](index=2&type=chunk) - The Loan Agreement includes a conversion option for **up to $5.0 million** of the outstanding principal into common stock at a conversion price of **$6.98 per share**[194](index=194&type=chunk) | Metric (Notes Payable) | March 31, 2023 | June 30, 2022 | | :--------------------- | :------------- | :------------ | | Notes Payable | $7,500,000 | $15,000,000 | | Net of current portion | $7,405,632 | $12,138,686 | [Note 9. Fair Value Measurements](index=16&type=section&id=9.%20Fair%20Value%20Measurements) This note explains BioVie Inc.'s fair value measurements for financial instruments, particularly derivative liabilities, using a three-level hierarchy - Fair values of financial instruments are determined using a hierarchy (Level 1, 2, 3), maximizing observable inputs[162](index=162&type=chunk) | Derivative Liabilities (Level 3) | March 31, 2023 | June 30, 2022 | | :------------------------------- | :------------- | :------------ | | Warrants | $1,956,781 | $194,531 | | Conversion Option | $2,580,425 | $188,030 | | Total Derivatives | $4,537,206 | $382,561 | - The total change in fair value of derivative liabilities was approximately **$4.2 million** for the nine months ended March 31, 2023, recorded in the statement of operations[7](index=7&type=chunk) [Note 10. Equity Transactions](index=19&type=section&id=10.%20Equity%20Transactions) This note details BioVie Inc.'s equity instruments, including stock options, warrants, restricted stock units, and stock issuance proceeds | Equity Instrument (March 31, 2023) | Number Outstanding |\n| :--------------------------------- | :----------------- |\n| Stock Options | 3,443,997 |\n| Warrants | 7,770,285 |\n| Restricted Stock Units | 527,549 | | Stock-Based Compensation Expense (9 Months Ended Mar 31) | 2023 | 2022 | | :------------------------------------------------------- | :------------ | :------------ | | Restricted Stock Units | $1,589,526 | $384,454 | | Stock Options | $3,480,425 | $4,004,718 | - During the nine months ended March 31, 2023, the company sold **7,372,691 shares** of common stock under a Sales Agreement for net proceeds of **$48.2 million**[205](index=205&type=chunk) [Note 11. Leases](index=23&type=section&id=11.%20Leases) This note describes BioVie Inc.'s lease arrangements, including right-of-use assets, lease liabilities, and weighted average lease terms - The company's San Diego office relocated to a new lease term of **38 months**, commencing March 1, 2022, with a monthly base rate of **$4,175**[19](index=19&type=chunk) | Lease Metric | March 31, 2023 | June 30, 2022 | | :--------------------------- | :------------- | :------------ | | Right-of-use asset, net | $90,549 | $118,254 | | Total operating lease liabilities | $97,779 | $126,298 | | Weighted average remaining lease term | **2.0 years** | **2.8 years** | | Weighted average discount rate | **10.75%** | **10.75%** | [Note 12. Commitments and Contingencies](index=24&type=section&id=12.%20Commitments%20and%20Contingencies) This note outlines BioVie Inc.'s royalty obligations on net sales of its drug candidates BIV201 and terlipressin products - The Company is obligated to pay a low single-digit royalty on net sales of BIV201 to members of LAT Pharma, PharmaIn Corporation, and The Barrett Edge, Inc[71](index=71&type=chunk)[153](index=153&type=chunk) - The Company is obligated to pay a low single-digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645, capped at a maximum of **$200,000** per year[39](index=39&type=chunk) [Note 13. Employee Benefit Plan](index=24&type=section&id=13.%20Employee%20Benefit%20Plan) This note details BioVie Inc.'s 401K plan, including company matching contributions for employee retirement savings - The Company sponsors a 401K Plan and matches **5%** of the first **5%** of an employee's contributions[23](index=23&type=chunk) | 401K Contributions | 3 Months Ended Mar 31, 2023 | 9 Months Ended Mar 31, 2023 | | :----------------- | :-------------------------- | :-------------------------- | | Company Match | $16,000 | $80,100 | [Note 14. Subsequent Events](index=24&type=section&id=14.%20Subsequent%20Events) This note reports BioVie Inc.'s equity sales and net proceeds received after the March 31, 2023, reporting period - After March 31, 2023, the Company sold **162,767 shares** of common stock for net proceeds of **$1.3 million** under its Sales Agreement[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses BioVie Inc.'s financial condition and results of operations, highlighting increased net losses driven by higher R&D expenses for clinical trials and changes in derivative liabilities, alongside updates on its drug pipeline and liquidity status [Business Overview and Pipeline Updates](index=25&type=section&id=2.1%20Business%20Overview%20and%20Pipeline%20Updates) This section provides an overview of BioVie Inc.'s clinical-stage drug development and updates on its NE3107 and BIV201 pipeline candidates - BioVie Inc. is a clinical-stage company developing innovative drug therapies for chronic debilitating conditions, including neurological, neuro-degenerative disorders, and liver disease[82](index=82&type=chunk)[133](index=133&type=chunk)[217](index=217&type=chunk) - NE3107 is in a potentially pivotal **Phase 3 study** for mild to moderate Alzheimer's Disease (targeting primary completion in **Q4 2023**) and has completed a **Phase 2 study** for Parkinson's Disease, meeting safety and drug-drug interaction objectives[42](index=42&type=chunk)[113](index=113&type=chunk)[152](index=152&type=chunk) - The Orphan drug candidate BIV201 for refractory ascites due to liver cirrhosis, with FDA Fast Track status, was paused in March 2023 after showing a **34% reduction** in ascites fluid in treated patients[25](index=25&type=chunk)[114](index=114&type=chunk) [Results of Operations](index=26&type=section&id=2.2%20Results%20of%20Operations) This section analyzes BioVie Inc.'s financial performance, focusing on net loss, operating expenses, and R&D costs for recent periods [Three Months Ended March 31, 2023 vs. 2022](index=26&type=section&id=2.2.1%20Three%20Months%20Ended%20March%2031%2C%202023%20vs.%202022) This section compares BioVie Inc.'s financial results for the three months ended March 31, 2023, and 2022, highlighting changes in net loss and expenses | Metric (3 Months Ended Mar 31) | 2023 | 2022 | Change | | :----------------------------- | :------------ | :------------ | :------------ | | Net Loss | $(15.0)M | $(7.0)M | $(8.0)M | | R&D Expenses | $11.2M | $3.6M | +$7.6M | | SG&A Expenses | $2.5M | $2.1M | +$0.4M | - The increase in R&D expenses was primarily due to significantly more active Neuroscience NE3107 studies, with the Parkinson's **Phase 2 study** reporting top results and the Alzheimer's **Phase 3 study** reaching full enrollment[191](index=191&type=chunk)[219](index=219&type=chunk) [Nine Months Ended March 31, 2023 vs. 2022](index=26&type=section&id=2.2.2%20Nine%20Months%20Ended%20March%2031%2C%202023%20vs.%202022) This section compares BioVie Inc.'s financial results for the nine months ended March 31, 2023, and 2022, detailing changes in net loss and expenses | Metric (9 Months Ended Mar 31) | 2023 | 2022 | Change | | :----------------------------- | :------------ | :------------ | :------------ | | Net Loss | $(41.1)M | $(18.0)M | $(23.1)M | | Total Operating Expenses | $34.1M | $18.0M | +$16.1M | | R&D Expenses | $25.0M | $11.4M | +$13.6M | | SG&A Expenses | $8.9M | $6.4M | +$2.5M | | Other Expense, Net | $7.0M | $0.035M | +$7.0M | - The **$13.6 million** increase in R&D expenses was mainly driven by **$12.3 million** from increased clinical activities, particularly for Neuroscience NE3107 studies[47](index=47&type=chunk)[83](index=83&type=chunk) - The **$7.0 million** increase in other expenses was primarily due to a **$5.3 million** change in the fair value of derivative liabilities and a **$2.0 million** increase in interest expense[221](index=221&type=chunk)[222](index=222&type=chunk) [Capital Resources and Liquidity](index=27&type=section&id=2.3%20Capital%20Resources%20and%20Liquidity) This section discusses BioVie Inc.'s financial resources, liquidity position, and dependence on future financing due to lack of revenue | Metric (March 31, 2023) | Amount | | :---------------------- | :------------ | | Cash & US Treasury Bills| $43.8 million | | Working Capital | $28.0 million | | Stockholders' Equity | $21.7 million | | Accumulated Deficit | $(292.1) million | - The company has not generated any revenue and expects no revenue in the foreseeable future, making future operations dependent on securing additional financing[240](index=240&type=chunk) - Management expects future funding sources to include equity sales, loans, or other strategic transactions[240](index=240&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=2.4%20Critical%20Accounting%20Policies%20and%20Estimates) This section confirms no significant changes to BioVie Inc.'s critical accounting policies for the nine months ended March 31, 2023 - No significant changes to critical accounting policies were identified for the nine months ended March 31, 2023, compared to the prior fiscal year[223](index=223&type=chunk) [Recent Accounting Pronouncements](index=28&type=section&id=2.5%20Recent%20Accounting%20Pronouncements) This section states that recent accounting pronouncements are not expected to materially impact BioVie Inc.'s financial statements - Recent accounting pronouncements are not expected to have a material impact on the company's balance sheets or statements of operations[50](index=50&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risks include uncertainties related to the COVID-19 pandemic's long-term impact on financial markets and its ability to raise funds, as well as potential liquidity concerns in the financial services industry affecting access to cash or new financing - The long-term impact of the COVID-19 pandemic on financial markets and the overall economy remains uncertain, potentially adversely affecting the company's ability to raise funds[29](index=29&type=chunk)[116](index=116&type=chunk) - The company monitors the financial stability of institutions holding its cash, but heightened uncertainties in the financial services industry could threaten its ability to access cash or secure new financing[74](index=74&type=chunk)[160](index=160&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were deemed effective at a reasonable assurance level as of March 31, 2023, with no material changes in internal control over financial reporting during the quarter - Disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2023[243](index=243&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2023[84](index=84&type=chunk) PART II – OTHER INFORMATION This section details legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) To the company's knowledge, neither it nor its officers or directors are party to any material legal proceedings or litigation, and there are no judgments against them - Neither the Company nor its officers or directors are party to any material legal proceeding or litigation, and no judgments exist against them[225](index=225&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including future dilution from equity offerings, warrants, options, RSUs, and contingent stock consideration, as well as substantial control over management by certain stockholders who are also officers and directors - Future equity offerings, options, warrants, stock awards, or other arrangements may lead to future dilution for existing stockholders[34](index=34&type=chunk)[55](index=55&type=chunk)[226](index=226&type=chunk) - The company is obligated to issue **up to 18 million shares** of common stock upon achievement of certain clinical, regulatory, and commercial milestones for its drug candidates, which could further dilute existing stockholders[1](index=1&type=chunk)[246](index=246&type=chunk) - Certain stockholders who are also officers and directors, including the majority shareholder Mr. Terren Peizer, have significant control (**65% of common stock**) over the company's management and matters requiring member approval[35](index=35&type=chunk)[227](index=227&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - No unregistered sales of equity securities were reported[248](index=248&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - No defaults upon senior securities were reported[229](index=229&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[37](index=37&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) The company reported no other material information for this item - No other material information was reported[36](index=36&type=chunk)[75](index=75&type=chunk)[229](index=229&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the report, including amendments to bylaws, certifications from the CEO and CFO, and XBRL taxonomy documents - Exhibits include Amendment No. 2 to Asset Purchase Agreement, certifications of CEO and CFO (pursuant to 18 U.S.C. Section 1350 and Rule 13a-14(a)), and XBRL taxonomy extension documents[38](index=38&type=chunk)[86](index=86&type=chunk)[230](index=230&type=chunk)[231](index=231&type=chunk)

On August 20, 2021, the Company awarded 58,759 restricted stock units ("RSUs") to the Company's President and CEO under the Company's 2019 Omnibus Incentive Equity Plan (the "2019 Omnibus Plan") as his salary for the period from April 27, 2021, the date of his appointment, through December 31, 2021. The number of RSUs awarded was based on a prorated annual base salary of $600,000 at a 10% discount to the grant date fair value of $7.74 per share of the Company's common stock. Each RSU awarded to the CEO enti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________to _____________ Commission File Number: 001-39015 BIOVIE INC. (Exact name of registrant as specified in its charter) Nevada 46-2510769 (State o ...