BIOVIE INC. 10-Q

Item 1. Financial Statements BioVie Inc. Condensed Balance Sheets (Unaudited) September 30, June 30, 2024 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 20,023,405 $ 23,843,798 Prepaid and other current assets 127,680 204,392 Total current assets 20,151,085 24,048,190 Operating lease right-of-use assets, net 390,777 406,726 Intangible assets, net 350,374 407,718 Goodwill 345,711 345,711 TOTAL ASSETS $ 21,237,947 $ 25,208,345 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accrued expenses $ 3,452,972 $ 3,586,912 Current portion of operating lease liabilities 63,664 60,343 Current portion of note payable, net of financing cost, unearned premium and discount of $ 820,242 at September 30, 2024 and $ 701,210 at June 30, 2024 3,320,242 5,701,210 Warrant liability 1,254 3,771 Total current liabilities 6,838,132 9,352,236 Operating lease liabilities, net of current portion 332,730 349,894 TOTAL LIABILITIES 7,170,862 9,702,130 Commitments and contingencies (Note 10) STOCKHOLDERS' EQUITY : Preferred stock; $ 0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding - - Common stock, $ 0.0001 par value; 800,000,000 shares authorized at September 30, 2024 and June 30, 2024, respectively; 7,982,986 shares issued of which 7,956,660 shares are outstanding at September 30, 2024; and 6,216,398 shares issued of which 6,190,072 shares outstanding at June 30, 2024 6,406 6,229 Additional paid in capital 352,770,440 349,732,674 Accumulated deficit ( 338,709,734 ) ( 334,232,661 ) Treasury stock ( 27 ) ( 27 ) Total stockholders' equity 14,067,085 15,506,215 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 21,237,947 $ 25,208,345 See accompanying notes to unaudited condensed financial statements 4 Table of Contents BioVie Inc. Condensed Statements of Operations and Comprehensive Loss (Unaudited) Three Months Ended Three Months Ended September 30, 2024 September 30, 2023 OPERATING EXPENSES: Amortization of intangible assets $ 57,344 $ 57,344 Research and development expenses 1,990,198 8,875,659 Selling, general and administrative expenses 2,074,540 1,942,818 TOTAL OPERATING EXPENSES 4,122,082 10,875,821 LOSS FROM OPERATIONS ( 4,122,082 ) ( 10,875,821 ) OTHER EXPENSE (INCOME): Change in fair value of derivative liabilities ( 2,517 ) ( 707,802 ) Interest expense 256,024 1,004,668 Interest income ( 223,557 ) ( 462,223 ) TOTAL OTHER EXPENSE (INCOME), NET 29,950 ( 165,357 ) NET LOSS $ ( 4,152,032 ) $ ( 10,710,464 ) Deemed dividend related to ratchet adjustment to warrants 325,041 - NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ ( 4,477,073 ) $ ( 10,710,464 ) NET LOSS PER COMMON SHARE - Basic $ ( 0.70 ) $ ( 2.92 ) - Diluted $ ( 0.70 ) $ ( 2.92 ) WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - Basic 6,398,360 3,672,490 - Diluted 6,398,360 3,672,490 NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ ( 4,477,073 ) $ ( 10,710,464 ) Other comprehensive loss Unrealized gain on available-for-sale investments - - Reclassification of unrealized gains on available-for-sale investments upon settlement - ( 176,591 ) Total other comprehensive loss - ( 176,591 ) Comprehensive loss $ ( 4,477,073 ) $ ( 10,887,055 ) See accompanying notes to unaudited condensed financial statements 5 Table of Contents BioVie Inc. Condensed Statements of Changes in Stockholders’ Equity (Unaudited) Accumulated Common Stock Common Stock Additional Paid in Treasury Stock Treasury Stock Other Comprehensive Accumulated Total Stockholders' Shares Amount Capital Shares Amount Income Deficit Equity Balance, June 30, 2023 3,645,183 $ 3,643 $ 316,385,759 ( 2,288 ) $ ( 2 ) $ 176,591 $ ( 301,225,705 ) $ 15,340,286 Stock-based compensation - stock options - - 808,027 - - - - 808,027 Stock-based compensation - restricted stock units - - 380,834 - - - - 380,834 Proceeds from issuance of common stock, net of costs of $118,891 43,220 4 1,905,832 - - - - 1,905,836 Issuance of common stock from vesting of - restricted stock units 3,873 - - - - - - - Net loss - - - - - - ( 10,710,464 ) ( 10,710,464 ) Relcassification of unrealized gains on available for sale investments upon settlement - - - - - ( 176,591 ) - ( 176,591 ) Balance, September 30, 2023 3,692,276 $ 3,647 $ 319,480,452 ( 2,288 ) $ ( 2 ) $ - $ ( 311,936,169 ) $ 7,547,928 Balance, June 30, 2024 6,216,398 $ 6,229 $ 349,732,674 ( 26,326 ) $ ( 27 ) $ - $ ( 334,232,661 ) $ 15,506,215 Stock-based compensation - stock options - - 118,898 - - - - 118,898 Stock-based compensation - restricted stock units - - 301,491 - - - - 301,491 Issuance of common stock from vesting of - restricted stock units 3,408 - - - - - - - Stock-based compensation - issuance of common stock for services rendered 15,000 2 33,448 - - - - 33,450 Proceeds from issuance of common stock, net of costs of $747,408 1,627,943 163 2,258,900 - - - - 2,259,063 Issuance of additional shares for fractional shares effected by the reverse split 120,237 12 ( 12 ) - - - - - Deemed dividend for ratchet adjustment to warrants - - 325,041 - - - ( 325,041 ) - Net Loss - - - - - - ( 4,152,032 ) ( 4,152,032 ) Balance, September 30, 2024 7,982,986 $ 6,406 $ 352,770,440 ( 26,326 ) $ ( 27 ) $ - $ ( 338,709,734 ) $ 14,067,085 See accompanying notes to unaudited condensed financial statements 6 Table of Contents BioVie Inc. Condensed Statements of Cash Flows (Unaudited) Three Months Ended Three Months Ended September 30, 2024 September 30, 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 4,152,032 ) $ ( 10,710,464 ) Adjustments to reconcile net loss to net cash used in operating activities: Amortization of intangible assets 57,344 57,344 Stock based compensation - restricted stock units 301,491 380,834 Stock based compensation expense - stock options 118,898 808,027 Stock based compensation expense - issuance of common stock for services rendered 33,450 - Amortization of financing costs 9,456 37,825 Accretion of unearned loan discount 88,970 355,877 Accretion of loan premium 20,606 82,424 Realized gain on maturity of available-for sale - ( 223,865 ) Non-cash lease expense from right-of-use assets 15,949 10,041 Change in fair value of derivative liabilities ( 2,517 ) ( 707,802 ) Changes in operating assets and liabilities: Prepaid and other current assets 76,712 ( 1,446,761 ) Accounts payable and accrued expenses ( 133,940 ) ( 761,499 ) Operating lease liabilities ( 13,843 ) ( 10,645 ) Other current liabilities - ( 48,385 ) Net cash used in operating activities ( 3,579,456 ) ( 12,177,049 ) CASH FLOWS FROM INVESTING ACTIVITIES: Proceeds from (purchases of) U.S. Treasury Bills (available-for-sale) - 14,525,000 Net cash provided by (used in) investing activities - 14,525,000 CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance of common stock 2,259,063 1,905,836 Payments of note payable ( 2,500,000 ) ( 2,500,000 ) Net cash used in financing activities ( 240,937 ) ( 594,164 ) Net change in cash and cash equivalents ( 3,820,393 ) 1,753,787 Cash and cash equivalents, beginning of period 23,843,798 19,460,883 Cash and cash equivalents, end of period $ 20,023,405 $ 21,214,670 SUPPLEMENTAL CASH FLOW INFORMATION: Cash paid for interest $ 136,992 $ 528,541 SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES: Reclassification of unrealized gains on U.S. Treasury Bills (available-for-sale investments) upon settlement $ - $ 176,591 Deemed dividend for ratchet adjustment to warrants $ 325,041 $ - See accompanying notes to unaudited condensed financial statements 7 Table of Contents BioVie Inc. Notes to Condensed Financial Statements For the Three Months Ended September 30, 2024 and 2023 (unaudited) 1. Background Information BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease. The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021 . The acquired assets included NE3107. NE3107 is an investigational, novel, orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), and NE3107 could, if approved by the U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD. Neurodengenerative Disease Program In neurodegenerative disease, the Company’s drug candidate Bezisterim (NE3107) inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD. Alzheimer’s Disease On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD. The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice daily. Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”) for potential further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data. The trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients left the trial underpowered for the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to be collected and analyzed. Parkinson’s Disease The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met. 8 Table of Contents Long COVID Program In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program of the Congressionally Directed Medical Research Programs. In August 2024, U.S. Army Medical Research and Development Command, Office of Human Research Oversight (“OHRO”) approved the Company’s plan to evaluate bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. and the FDA authorized our Investigational New Drug (“IND”) application for bezisterim (NE3107) allowing us to study a novel, anti-inflammatory approach or the treatment of the debilitating neurocognitive symptoms associated with long covid. The Company anticipates the trial to commence by early 2025. The Company has been reimbursed approximately $325,000 for the trial during the three months ended September 30, 2024. Liver Disease Program In liver disease, our investigational drug candidate BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation. In June 2021, the Company initiated a Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period. In March 2023, the Company announced enrollment was paused and that data from the first 15 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. 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. In June 2023, the Company 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. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The BIV201 development program was initiated by LAT Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company 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 our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. 2. Liquidity and Going Concern The Company’s operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital. The Company’s financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of September 30, 2024, the Company had working capital of approximately $ 13.3 million, cash and cash equivalents of approximately $ 20.0 million, stockholders’ equity of approximately $ 14.1 million, and an accumulated deficit of approximately $ 338.7 million. The Company is in the pre-revenue stage and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed. Projected cash flows could be extended if further measures are taken to delay planned expenditures on our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs. The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions. 9 Table of Contents Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. 3. Significant Accounting Policies Basis of Presentation – Interim Financial Information These unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United State of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”) for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim condensed financial statements furnished reflect all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. The condensed balance sheet at June 30, 2024, was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. These unaudited interim condensed financial statements should be read in conjunction with the Company’s audited financial statements for the fiscal years ended June 30, 2024 and 2023 in our Annual Report on Form 10-K filed with the SEC on September 30, 2024 (the “2024 Form 10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2024 Form 10-K. Cash and cash equivalents Cash and cash equivalents consisted of cash deposits and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S. Treasury Bills with original maturities of three months or less. Investments in U.S. Treasury Bills Investments in U.S. Treasury Bills with maturities greater than three months, are accounted for as available-for-sale and are recorded at fair value. Realized gains were included in the accompanying condensed statements of operations and comprehensive loss from the settlement of available-for-sale investments during the three months ended September 30, 2023. The Company had no outstanding investment securities with original maturities of greater than three months at the time of purchase as of and during the three months ended September 30, 2024. Concentration of Credit Risk in the Financial Service Industry As of September 30, 2024, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, if liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations. 10 Table of Contents Fair value measurement of assets and liabilities We determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value: Level 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 - Inputs are unobservable inputs based on our assumptions. The Company’s financial instruments include cash, accounts payable, the carrying value of the operating lease liabilities and notes payable. The carrying amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items. The carrying amounts of notes payable and operating lease liabilities approximate their fair values since they bear interest at rates which approximate market rates for similar debt instruments. Net Loss per Common Share Basic net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted net loss per common share is computed by dividing the net loss attributable to Common Stockholders by the weighted average number of shares of Common Stock outstanding and potentially outstanding shares of Common Stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, and convertible debentures. For the three months ending September 30, 2024 and 2023, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods presented. The weighted average number of common shares outstanding at September 30, 2024 of 6,398,360 includes the weighted average effect of the pre-funded warrants issued in connection with the September 2024 Offering, the exercise of which requires nominal consideration for the delivery of the shares of common stock (see Note 8). The table below shows the potential shares of common stock, presented based on amounts outstanding at each year end, which were excluded from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect: Schedule of dilutive securities were excluded from the computation of diluted loss per share September 30, 2024 September 30, 2023 Number of Shares Number of Shares Stock Options 517,996 395,286 Warrants 4,316,002 777,029 Restricted Stock Units 34,564 55,773 Notes payable conversion option 35,817 71,633 Total 4,904,379 1,299,721 Reverse stock split The company effected a 1:10 reverse split of the issued and outstanding shares of its Class A commons stock which was approved by the board of directors after the approval obtained from shareholders at a special meeting on July 29, 2024 which became effective on Nasdaq on August 6, 2024, 5 trading days after the shareholders’ approval was obtained. All historical share and earnings per share amounts have been retroactively adjusted to reflect the split. Grant program The Company records expenses related to the DOD long Covid Program as such expenses are incurred. The reimbursement of such expenses is recognized upon receipt of the reimbursement as a credit against the respective expense account. Recent Accounting Pronouncements In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (“DISE”), which will require additional disclosure of the nature of expenses included in the income statement in response to longstanding requests from investors for more information about an entity’s expenses. The new standard requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The new standard will be effective for public companies for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. The Company is currently evaluating the impact of this accounting standard update on its financial statements. 11 Table of Contents 4. Intangible Assets The Company’s intangible assets consist of intellectual property acquired from LAT Pharma, Inc. and are amortized over their estimated useful lives. The following is a summary of the Company’s intangible assets: Schedule of intangible assets September 30, 2024 June 30, 2024 Intellectual Property $ 2,293,770 $ 2,293,770 Less: Accumulated Amortization ( 1,943,396 ) ( 1,886,052 ) Intellectual Property, Net $ 350,374 $ 407,718 Amortization expense was $ 57,344 in each of the three-month periods ended September 30, 2024 and 2023. The Company amortizes intellectual property over the expected original useful lives of 10 years. Estimated future amortization expense is as follows: Schedule of future amortization expense Year ending June 30, 2025 (Remaining 9 months) $ 172,033 2026 178,341 $ 350,374 5. Related Party Transactions Equity Transactions with Acuitas On July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (“Acuitas”), the Company’s largest stockholder, pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 363,636 shares of the Company’s Common Stock, at a price of $16.50 per share (the “PIPE Shares”), and (ii) a warrant to purchase 727,273 shares of Common Stock (“PIPE Warrant Shares”), at an exercise price of $18.20, with a term of exercise of five years. The down round feature reduced the exercise price of the PIPE Warrant Shares to $10.00 per share on March 6, 2024 and again to $1.53 per share on September 25, 2024 in connection with the offering further described in Note 8 as the Company sold stock at a price lower than its initial exercise price. The Company calculated the difference in fair value of the PIPE Warrant Shares between the stated exercise price and the reduced exercise price and recorded $ 325,041 as a deemed dividend in the accompanying condesnsed statement of changes in stockholders’ equity. The fair value of the PIPE Warrant Shares were estimated using the Black Scholes Method with the following inputs, the stock price of $ 1.20 , exercise price of $ 1.53 and $ 10.00 , remaining term of 2.9 years, risk free rate of 3.5 % and volatility of 93.0 % . 12 Table of Contents 6. Notes Payable On November 30, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and Avenue Venture Opportunities Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan was funded (“Tranche 1”). The Loan provided for an additional $5 million to be available to the Company on or prior to September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials, which were not achieved. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00 % plus the prime rate as reported in The Wall Street Journal and (b) 10.75%. The prime rate on September 30, 2024, was 8.50 % . The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024. The Loan Agreement required monthly interest-only payments during the first eighteen months of the term of the Loan. Following the interest-only period, on July 1, 2023, the Company pays equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued interest is due. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal amount of the Loan that is prepaid during the interest-only period; and (b) a prepayment fee in an amount equal to 1.0% of the principal amount of the Loan that is prepaid after the interest-only period. At the Loan’s maturity date, or on the date of the prepayment of the Loan, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and Tranche 2, which amounts to $850,000 (the “Loan Premium”). The Loan Agreement includes a conversion option to convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s Common Stock at a conversion price of $69.80 per share (the “Conversion Option”). On the Closing Date, the Company issued to Avenue warrants to purchase 36,101 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal to $58.20. The Avenue Warrants are exercisable until November 30, 2026. The amount of the carrying value of the notes payable was determined by allocating portions of the outstanding principal of the notes, approximately $ 1.4 million, to the fair value of the Avenue Warrants, and approximately $ 2.2 million to the fair value of the embedded Conversion Option. Accordingly, the total amount of unearned discount of approximately $3.6 million, the total direct financing cost of approximately $ 390,000 and the Loan Premium of $ 850,000 are being amortized using the effective interest method over the term of the Loan. The adjusted effective interest rate is 24%. Total interest expense associated with this loan was approximately $ 252,000 , which is reflected as a component of interest expense on the accompanying condensed statements of operations and comprehensive loss for the three months ended September 30, 2024. Interest expense associated with this loan was comprised of interest incurred on the outstanding principal of the loan of approximately $ 132,000 , amortization of financing costs of approximately $ 9,500 , amortization of the unearned discount of $ 89,000 , and the accretion of the Loan Premium of approximately $ 21,000 . Total interest expense for the three months ended September 30, 2023 was approximately $ 1 million on the accompanying condensed statements of operations and comprehensive loss. Interest expense was comprised of interest incurred on the outstanding principal of the loan of approximately $ 525,000 , amortization of financing costs of approximately $ 38,000 , amortization of the unearned discount of approximately $ 356,000 and the accretion of Loan Premium of approximately $ 82,000 . As of September 30, 2024, the remaining principal balance of $ 2.5 million under the Loan is payable in 3 monthly equal installments. For the three months ended September 30, 2024, the Company paid back $ 2.5 million of the original loan of $ 15 million. 13 Table of Contents The following is a summary of the Notes Payable as of September 30, 2024 and June 30, 2024: Current portion of Notes Payable Schedule of note payable September 30, 2024 June 30, 2024 Current portion of Notes Payable $ 2,500,000 $ 5,000,000 Less: debt financing costs ( 2,364 ) ( 11,820 ) Less: unearned discount ( 22,242 ) ( 111,212 ) Plus: accretion of Loan Premium 844,848 824,242 Current portion of Notes Payable, net of financing costs, unearned premium and discount $ 3,320,242 $ 5,701,210 Estimated future amortization expense and accretion of Loan Premium are as follows: Schedule of estimated future amortization expense and accretion of premium Unearned Discount Debt Financing Costs Loan Premium Year ending June 30, 2025 (Remaining 9 months) $ 22,242 $ 2,364 $ 5,152 Total $ 22,242 $ 2,364 $ 5,152 14 Table of Contents 7. Fair Value Measurements At September 30, 2024 and June 30, 2024, the estimated fair value of derivative liabilities measured on a recurring basis are as follows: Schedule of derivative liabilities at fair value Fair Value Measurements at September 30, 2024 Level 1 Level 2 Level 3 Total Derivative liability - Warrants $ - $ - $ 1,254 $ 1,254 Derivative liability - Conversion Option - - - - Total derivative liabilities $ - $ - $ 1,254 $ 1,254 Fair Value Measurements at June 30, 2024 Level 1 Level 2 Level 3 Total Derivative liability - Warrants $ - $ - $ 3,771 $ 3,771 Derivative liability - Conversion option - - - - Total derivative liabilities $ - $ - $ 3,771 $ 3,771 The following table presents the activity for level 3 liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2024: Fair value, liabilities measured on recurring basis Derivative liabilities - Warrants Derivative liability - Conversion Option on Convertible Debenture Balance at June 30, 2024 $ 3,771 $ - Additions to level 3 liabilities - - Change in fair value of level 3 liabilities ( 2,517 ) - Transfer in and/or out of Level 3 - - Balance at September 30, 2024 $ 1,254 $ - 15 Table of Contents The following table presents the activity for level 3 liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2023: Derivative liability - Warrants Derivative liability - Conversion Option Balance at June 30, 2023 $ 894,280 $ 925,762 Additions to level 3 liabilities - - Change in fair value of level 3 liabilities ( 271,883 ) ( 435,919 ) Transfer in and/or out of level 3 - - Balance at September 30, 2023 $ 622,397 $ 489,843 The fair values of derivative liabilities for the Avenue Warrants and Conversion Option at September 30, 2024, in the accompanying condensed balance sheets, were approximately $1,300 and approximately zero, respectively. The total change in the fair value of the derivative liabilities totaled approximately $2,500 and $708,000 for the three months ended September 30, 2024 and 2023, respectively; and accordingly, was recorded in the accompanying condensed statements of operations and comprehensive loss. The assumptions used in the Black Scholes model to value the derivative liabilities at September 30, 2024 included the closing stock price of $ 1.20 per share; for the Avenue Warrants, the exercise price of $ 58.20 , remaining term 2.2 year, risk free rate of 3.7 % and volatility of 91.0 % ; and for the Conversion Option, the conversion price of $ 69.80 ; remaining term of 2 months, risk free rate of 4.8 % and volatility of 75.0 % . Derivative liability – Avenue Warrants The Avenue Warrants were not considered to be indexed to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompanying condensed balance sheets at September 30, 2024 and June 30, 2024, respectively. The Black Scholes model was used to calculate the fair value of the derivative warrant to bifurcate the amount from the Avenue Loan amount funded. The Avenue Warrants are recorded at their fair values at the date of issuance and remeasured at each subsequent reporting period end date. Embedded derivative liability – Conversion Option The Conversion Option is accounted for as an embedded derivative liability and required bifurcation from the Loan amount. The Black Scholes model was used to calculate the fair value of the Conversion Option to bifurcate it from the Loan. Financial assets As of September 30, 2024, investments in U.S. Treasury Bills were valued through use of quoted prices and are classified as Level 1. The following table presents information about our assets that are measured at fair value on a recurring basis using the above input categories. Measured at fair value on a recurring basis Fair Value Measurements at September 30, 2024 Level 1 Level 2 Level 3 Total Cash $ 6,326,252 $ - $ - $ 6,326,252 U.S. Treasury Bills due in 3 months or less at purchase 13,697,153 - - 13,697,153 Total $ 20,023,405 $ - $ - $ 20,023,405 16 Table of Contents Fair Value Measurements at June 30, 2024 Level 1 Level 2 Level 3 Total Cash $ 12,763,941 $ - $ - $ 12,763,941 U.S. Treasury Bills due in 3 months or less at purchase 11,079,857 - - 11,079,857 Total $ 23,843,798 $ - $ - $ 23,843,798 8. Equity Transactions Issuance of common stock for cash On August 31, 2022, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock through the Agents, subject to the terms and conditions of the Sales Agreement. On April 6, 2023, the Company and B. Riley Securities, Inc. mutually agreed to terminate B. Riley Securities, Inc.’s role as a sales agent under the Sales Agreement. During the three months ended September 30, 2024, the Company sold 2,143 shares of common stock under the Sales Agreement for total net proceeds of $ 6,400 after 3 % commissions and expenses of approximately $ 200 . During the three months ended September 30, 2023, the Company sold 43,220 shares of common stock under the Sales Agreement for total net proceeds of $ 1.9 million after 3 % commissions and expenses of approximately $ 119,000 . On September 25, 2024, the Company closed a best efforts public offering (the “September 2024 Offering”) of 1,360,800 shares of its common stock, par value $ 0.0001 per share, pre-funded warrants (the “September Pre-funded Warrants”) to purchase 600,000 shares of Common Stock, and warrants to purchase up to 1,960,800 shares of Common Stock (the “September Common Warrants”) at a combined public offering price of $ 1.53 per Share, or September Pre-funded Warrant, and the associated September Common Warrant. 265,000 September Pre-funded Warrants were exercised in the three months ended September 30, 2024 and reflected on the condensed statement of changes in stockholders’ equity as a component of proceeds from issuance of common stock. The September Common Warrants have an exercise price of $ 1.53 per share and are immediately exercisable upon issuance and will expire on the fifth anniversary date of the original issuance date. The gross proceeds to the Company from the September 2024 Offering were approximately $ 3.0 million, before deducting placement agent fees and offering expenses of approximately $747,000. Additionally, upon closing, the Company issued the placement agent warrants (“September Placement Agent’s Warrants”) to purchase 98,040 shares of Common Stock exercisable at a per share price of $1.91, which was equal to 125 % of the public offering price per share. The September Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from September 25, 2024. Issuance of common stock for services On August 12, 2024, the Company awarded 15,000 shares of Common Stock to a vendor as part of their fees in exchange for services. The fair value of the Common Stock at the date of issuance was $ 2.23 per share. The stock-based compensation expense related to this Common Stock issuance was $ 33,450 . Stock Options The following table summarizes the activity relating to the Company’s stock options for the three months ended September 30, 2024: Schedule of summarizes the activity relating to the Company’s stock options Options Weighted-Average Exercise Price Weighted Remaining Average Contractual Term Aggregate Intrinsic Value Outstanding at June 30, 2024 518,076 $ 54.11 6.1 $ - Options Expired ( 80 ) 87.50 - - Outstanding at September 30, 2024 517,996 $ 54.10 5.9 $ - Exercisable at September 30, 2024 321,382 $ 66.77 4.7 $ - 17 Table of Contents The Company recorded stock based compensation expense relating to the vesting of stock options of approximately $ 119,000 and $ 808,000 for the three months ended September 30, 2024 and 2023, respectively. Restricted stock units: On November 9, 2023, the Company issued equity awards for the board of directors’ annual compensation. Four directors received 18,270 RSUs with a grant date fair value of $ 30.10 per share. In addition, two directors received stock options to purchase 18,325 shares of common stock at an exercise price of $ 30.10 per share with a grant date fair value of $18.30 per share. The equity awards vest quarterly on February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’ meeting. During the three months ended September 30, 2024, 3,409 of these RSUs vested. On July 25, 2024, Mr. Gorlin resigned from the Board of Directors, and as a result, 1,159 of his RSUs were cancelled. The following table summarizes vesting of restricted stock units: Schedule of vesting of restricted common stock Number of Shares Weighted Average Grant Date Fair Value Per Share Unvested at June 30, 2024 40,291 $ 44.59 Vested ( 3,409 ) 30.10 Canceled ( 1,159 ) - Unvested at September 30, 2024 35,723 $ 46.99 The total stock-based compensation expense from restricted stock units for the three months ended September 30, 2024 and 2023 was approximately $ 301,000 and $ 381,000 , respectively. 18 Table of Contents Stock Warrants The following table summarizes the warrants activity during the three months ended September 30, 2024: Summary of warrants activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Life (Years) Aggregate Intrinsic Value Outstanding and exercisable at June 30, 2024 1,932,029 14.03 4.0 - Granted 2,658,840 1.54 5.0 - Exercised ( 265,000 ) 1.53 - - Expired ( 9,867 ) 22.50 - - Outstanding and exercisable at September 30, 2024 4,316,002 $ 5.66 4.5 $ - Of the above warrants outstanding at September 30, 2024, 271 expire in the fiscal year ending June 30, 2025, 3,518 expire in the fiscal year ending June 30, 2026, 763,373 expire in the fiscal year ending June 30, 2027, 1,155,000 expire in the fiscal year ending June 30, 2029 and 2,393,840 expire in the fiscal year ending June 30, 2030. As of September 30, 2024, the Company had 335,000 prefunded warrants, 3,882,962 warrants and 98,040 placement agent warrants outstanding. 9. Leases Office Leases The Company pays an annual rent of $ 2,200 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703. The rental agreement was for a 1 one-year term, commenced on October 1, 2023, and has been subsequently renewed for another year at the same rate. The Company’s San Diego office lease at 5090 Shoreham Place Suite 212, San Diego, CA 92122 commenced in February 2024. The current monthly base rate for the office space is $ 9,685 , with an annual increase of four percent. The term for the office lease is 60 months. Total operating lease expense for the three months ended September 30, 2024 and 2023 of approximately $ 32,000 and $ 13,000 , respectively, were included in the accompanying condensed statements of operations and comprehensive loss as a component of selling, general and administrative expenses. 19 Table of Contents The right-of-use asset, net and current and non-current portion of the operating lease liabilities included in the accompanying condensed balance sheets are as follows: Schedule of deferred tax assets September 30, 2024 June 30, 2024 Assets Operating lease right-of-use asset, net $ 390,777 $ 406,726 Liabilities Current portion of operating lease liability $ 63,664 $ 60,343 Operating lease liability, net of current portion 332,730 349,894 Total operating lease liability $ 396,394 $ 410,237 At September 30, 2024, the future estimated minimum lease payments under non-cancelable operating leases are as follows: Schedule of future estimated minimum lease payments under non-cancelable operating leases Year ending June 30, 2025 (Remaining 9 months) $ 89,199 2026 122,042 2027 126,313 2028 130,734 2029 77,796 Total minimum lease payments 546,084 Less amount representing interest ( 149,690 ) Present value of future minimum lease payments 396,394 Less current portion of operating lease liability ( 63,664 ) Operating lease liability, net of current portion $ 332,730 Total cash paid for amounts included in the measurement of lease liabilities were $ 29,055 and $ 12,900 for the three months ended September 30, 2024 and 2023, respectively. The weighted average remaining lease term and discount rate as of September 30, 2024 and June 30, 2024 were as follows: Schedule of weighted average remaining lease term and discount rate September 30, 2024 June 30, 2024 Weighted average remaining lease term (Years) Operating lease 4.3 4.6 Weighted average discount rate Operating lease 15.00 % 15.00 % 20 Table of Contents 10. Commitments and Contingencies Royalty Agreements Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc. Pursuant to the Technology Transfer Agreement entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), 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 and any future foreign issuances, capped at a maximum of $200,000 per year. Shareholder class action complaint On January 19, 2024, a purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al. , No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers as defendants. On February 22, 2024, a second, related putative securities class action was filed in the same court asserting similar claims against the same defendants, captioned Way v. BioVie Inc. et al. , No. 2:24-cv-00361. On April 15, 2024, the court consolidated these two actions under the caption In re BioVie Inc. Securities Litigation , No. 3:24-cv-00035, appointed the lead plaintiff, and approved selection of the lead counsel. On June 21, 2024, the lead plaintiff filed an amended complaint, alleging that the defendants made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the NM101 Phase 3 study and trial of bezisterim (NE3107) in mild to moderate probable AD, in violation of Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from December 7, 2022 through November 28, 2023, and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. The defendants filed a motion to dismiss the amended complaint on August 21, 2024 , and plaintiffs filed their opposition on October 21, 2024 . The defendant’s reply brief is due December 5, 2024. The Company believes the lawsuit is without merit and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding the outcome of the litigation. No adjustment or accruals have been reflected in the accompanying condensed financial statements. 11. Employee Benefit Plan On August 1, 2021, the Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which, all employees meeting eligibility requirements are able to participate. Subject to certain limitations in the Internal Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the first 5% of an employee’s contributions to the 401K Plan. The Company made contributions into the plan of approximately $ 34,500 and $ 30,900 , for the three months ended September 30, 2024 and 2023, respectively. 21 Table of Contents 12. Subsequent Events In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares of its common stock, par value $ 0.0001 per share, and two concurrent private placements of warrants to purchase up to 8,256,000 shares of Common Stock (the “October Common Warrants”) priced at-the-market under Nasdaq rules at prices ranging from $ 1.50 to $ 2.83 per share (the “October Offerings”) . The October Common Warrants have exercise prices ranging from $ 1.37 to $ 2.83 per share and are exercisable beginning six months following issuance and will expire on the fifth anniversary date of the original issuance dates. The gross proceeds to the Company from the October Offerings totaled approximately $ 15.9 million, before deducting placement agent fees and offering expenses of approximately $ 2.8 million. Additionally, upon closing of the October Offerings the Company issued placement agent warrants (the “October Placement Agent’s Warrants”) to purchase 412,800 shares of Common Stock in the aggregate exercisable at a per share price ranging from $ 1.88 to $ 3.54 , which was equal to 125% of the offering price per share in the applicable October Offering. The October Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from each of the respective closing dates of the October Offerings. Additionally in October, 1,216,300 of the common warrants from the September 2024 Offering were exercised at $ 1.53 per share for proceeds totaling approximately $ 1.9 million. 22 Table of Contents