Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against BioVie Inc. due to a class action complaint alleging breaches of fiduciary duties by the company's board of directors [1] Summary by Relevant Sections Allegations - The class action complaint alleges that during the Class Period from August 5, 2021, to November 29, 2023, BioVie made materially false and misleading statements and failed to disclose adverse facts about its business and operations [2] - Specific allegations include: - Lack of proper oversight of the Phase 3 clinical trial [2] - Negative impact of the COVID-19 pandemic on the trial's oversight [2] - Increased risk of unreliable data due to reliance on contract research organizations, leading to significant patient exclusions from the trial [2] - Failure of the Phase 3 clinical trial to meet its primary endpoints due to these exclusions [2] - Misleading statements regarding BioVie's business, operations, and compliance with current good clinical practices [2] Contact Information - Long-term stockholders of BioVie are encouraged to reach out for more information regarding the claims or their rights [3] - Contact can be made via email or telephone, with no cost or obligation to the stockholders [3] About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents investors in various complex litigations across state and federal courts [4]

Financial Performance - The net loss for the three months ended September 30, 2024, was approximately $4.2 million, a decrease of $6.5 million compared to a net loss of $10.7 million for the same period in 2023[123]. - Total operating expenses for the three months ended September 30, 2024, were approximately $4.1 million, down from $10.9 million in the same period in 2023, reflecting a decrease of approximately $6.8 million[124]. - Research and development expenses were approximately $2.0 million for the three months ended September 30, 2024, a decline of approximately $6.9 million from $8.9 million for the same period in 2023[125]. - As of September 30, 2024, the Company had working capital of approximately $13.3 million and cash and cash equivalents totaling approximately $20.0 million[131]. - The Company has not generated any revenue and does not expect to do so in the foreseeable future, relying on ongoing development and financing efforts[133]. Clinical Trials and Drug Development - The Phase 2 study of bezisterim (NE3107) for Parkinson's disease was completed in December 2022, with both primary and secondary objectives met[114]. - The Company received a clinical trial award of up to $13.1 million from the U.S. Department of Defense to evaluate bezisterim (NE3107) for long COVID, with trials expected to commence by early 2025[116]. - BIV201, an investigational drug for liver disease, showed a 53% reduction in ascites fluid for patients who completed treatment, sustained at a 43% reduction over three months post-treatment[119]. - The FDA has granted Fast Track and Orphan Drug status to BIV201, which is being evaluated for the treatment of ascites due to chronic liver cirrhosis[117]. - The Company anticipates finalizing protocol designs for the Phase 3 study of BIV201 following guidance from the FDA regarding clinical testing[120]. Capital Raising Activities - During the three months ended September 30, 2024, the Company sold approximately 2,143 shares of Common Stock for total net proceeds of approximately $6,400 after commissions and offering costs[135]. - The Company closed a public offering on September 25, 2024, of 1,360,800 shares at a combined public offering price of $1.53 per share, generating gross proceeds of approximately $3.0 million before expenses[136]. - In October 2024, the Company closed three registered direct offerings totaling 8,256,000 shares, with gross proceeds of approximately $15.9 million before expenses[137]. - The October Common Warrants have exercise prices ranging from $1.37 to $2.83 per share and are exercisable beginning six months following issuance[137]. - The Company issued placement agent warrants in the October Offerings to purchase 412,800 shares of Common Stock at prices ranging from $1.88 to $3.54 per share[137]. - The September Common Warrants have an exercise price of $1.53 per share and are immediately exercisable upon issuance[136]. - The Company incurred offering expenses of approximately $747,000 for the September 2024 Offering and approximately $2.8 million for the October Offerings[136][137]. - The September Placement Agent's Warrants are exercisable at a price of $1.91 per share, equal to 125% of the public offering price[136]. Accounting Policies - The Company added a Grant Program accounting policy for the three-month period ended September 30, 2024, with no other significant changes to critical accounting policies[138]. - The Company determined that recent accounting pronouncements are either not applicable or expected to have minimal impact on financial statements[139].

Core Viewpoint - BioVie Inc. has announced a registered direct offering of 1,146,000 shares of its common stock at a price of $2.83 per share, aiming to raise approximately $3.2 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on or about October 29, 2024, pending customary closing conditions [2]. - ThinkEquity is acting as the sole placement agent for this offering [2]. - The shares are being offered under a shelf registration statement filed with the SEC, which became effective on August 28, 2023 [3]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for working capital and general corporate purposes [2]. Group 3: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for chronic conditions, including neurological disorders and liver disease [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in Alzheimer's disease and Parkinson's disease [5]. - BioVie’s orphan drug candidate BIV201 is under evaluation for treating liver cirrhosis and ascites, with FDA Fast Track status [5].

Core Viewpoint - BioVie Inc. has announced a registered direct offering of 1,146,000 shares of its common stock at a price of $2.83 per share, aiming to raise approximately $3.2 million in gross proceeds for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The offering is priced at-the-market under Nasdaq rules, with total gross proceeds expected to be around $3.2 million before fees and expenses [1]. - The offering is set to close on or about October 29, 2024, pending customary closing conditions [2]. - ThinkEquity is acting as the sole placement agent for this offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be used for working capital and general corporate purposes [2]. Group 3: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for chronic debilitating conditions, including neurological disorders and liver disease [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in Alzheimer's disease and Parkinson's disease [5]. - BioVie’s Orphan drug candidate BIV201 is under evaluation for treating liver cirrhosis and ascites, with FDA Fast Track status [5].

Core Viewpoint - BioVie Inc. has successfully closed a registered direct offering of 4,443,000 shares of common stock at a price of $1.50 per share, raising gross proceeds of $6,664,500 for working capital and general corporate purposes [1][2]. Group 1: Offering Details - The registered direct offering involved the sale of common stock priced at $1.50 per share, with a total of 4,443,000 shares offered [1]. - In a concurrent private placement, the company issued unregistered warrants to purchase up to 4,443,000 shares at an exercise price of $1.37 per share, which will be exercisable six months after issuance and expire five years later [2]. - The gross proceeds from the offering are $6,664,500, before deducting placement agent fees and offering expenses [2]. Group 2: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for chronic debilitating conditions, including neurological disorders such as Alzheimer's and Parkinson's diseases, as well as advanced liver disease [6]. - The company's drug candidate, bezisterim, targets neuroinflammation and insulin resistance, which are significant factors in neurodegenerative diseases [6]. - BioVie’s orphan drug candidate BIV201, which has FDA Fast Track status, is being evaluated for its effectiveness in reducing further decompensation in patients with liver cirrhosis and ascites [6].

Core Viewpoint - BioVie Inc. has announced a registered direct offering of 4,443,000 shares of its common stock at a price of $1.50 per share, aiming to raise approximately $6.66 million before expenses [1][2]. Group 1: Offering Details - The offering includes unregistered warrants for investors to purchase an equal number of shares at an exercise price of $1.37, exercisable six months post-issuance and expiring five years later [1][2]. - The expected closing date for the offering is around October 22, 2024, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be allocated for working capital and general corporate purposes [2]. Group 3: Company Overview - BioVie Inc. is focused on developing innovative drug therapies for chronic conditions, including neurological disorders like Alzheimer's and Parkinson's, as well as advanced liver disease [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in neurodegenerative diseases [5]. - BioVie’s orphan drug candidate BIV201 is under FDA Fast Track status and is being prepared for Phase 3 clinical testing to address liver cirrhosis complications [5].

Core Viewpoint - BioVie Inc. has secured patents for its liquid formulation of terlipressin in multiple countries, which offers significant advantages for treating patients with cirrhosis and ascites, particularly in home-care settings [1][4][9]. Patent and Formulation - The company received a Notice of Allowance from the Japan Patent Office for its terlipressin formulation, expected to result in a patent issuance in 2 to 3 weeks [1]. - The allowed claims cover a novel liquid formulation of terlipressin acetate that is stable at room temperature for two years and can be packaged in a pre-filled syringe [2]. - BioVie has also received patent protection in India and Chile, with pending patents in Australia, Canada, China, Europe, Hong Kong, South Korea, Mexico, and Brazil [4][9]. Clinical Context - Patients with cirrhosis and ascites often accumulate large volumes of fluid in the abdomen, leading to a one-year survival rate of approximately 50% for those with refractory ascites [3]. - Current management options for these patients are limited and primarily involve procedures that provide only temporary relief [3]. Drug Approval and Development - Terlipressin is already used in over 40 countries for treating complications of liver cirrhosis and has recently been approved in the U.S. as a lyophilized powder for in-hospital use [4][9]. - BioVie’s liquid formulation is designed for home-care settings, offering advantages such as room-temperature stability and improved dosing convenience [4][9]. Financial Implications - The treatment of patients with cirrhosis and ascites incurs an estimated $5 billion in annual costs in the U.S. [6]. - BioVie has secured Orphan Drug designation and Fast Track status for BIV201, which is being evaluated for the treatment of ascites due to liver cirrhosis [10].

Financial Condition and Capital Needs - The company has no products approved for commercial sale and has never generated any revenues, which could lead to ceasing operations[73] - The company may need to raise substantial additional capital in the future to fund its operations, which could adversely affect its business[73] - The company has not generated any product revenues and does not expect to do so until it develops and receives approval for its product candidates[104] - The company may require substantial additional capital to fund operations and may be unable to raise such funds on acceptable terms, adversely affecting its business[104] - The company may need to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations, which could lead to significant dilution for existing shareholders[107] - The company has not established any revenues or operations that would provide long-term financial stability, raising substantial doubt about its ability to continue as a going concern[93] - The company has an accumulated deficit of approximately $334.2 million as of June 30, 2024[256] - The company is currently pursuing additional financing to support its ongoing development and commercialization efforts, with no assurance of success[258] Legal and Regulatory Risks - The company is currently subject to securities class action litigation, which may have a material adverse effect on its business and financial condition[85] - The company faces significant regulatory compliance requirements that may delay or prevent the commercialization of its product candidates[73] - The development and testing of drug candidates are subject to various risks, including regulatory approval uncertainties, which could lead to discontinuation of operations if unsuccessful[111] - Any delays in clinical trials or regulatory approvals could have a materially adverse effect on the company's business and may force it to cease operations[135] - The company has not established any reserves for potential liabilities related to pending or future lawsuits, which could materially affect its financial condition[89] Clinical Development and Trial Risks - The company reported significant deviations from the protocol and cGCP violations at 15 study sites during the Phase 3 clinical trial of bezisterim (NE3107), leading to the exclusion of all patients from these sites[80] - The company plans to consider employing the adaptive trial feature or designing a new Phase 3 study of bezisterim (NE3107) to achieve statistical significance[80] - The company has limited experience in conducting clinical trials necessary for FDA approval, which could adversely affect its ability to commercialize drug candidates BIV201 and bezisterim (NE3107) if protocols do not meet FDA standards[136] - The FDA cleared the drug candidate BIV201 for a mid-stage clinical trial, with the first patient enrolled on June 24, 2021; however, the trial was stopped in March 2023 after only 15 of the planned 30 patients were enrolled[112] - Encouraging data from the BIV201 trial indicated a reduction in ascites fluid accumulation during treatment compared to pre-treatment[112] - The company received FDA guidance in June 2023 regarding the design and endpoints for definitive clinical testing of BIV201 for treating ascites due to chronic liver cirrhosis[112] Intellectual Property Risks - The company is exposed to risks related to intellectual property rights, including potential infringement claims and challenges to patent validity[76] - The patent position of the company is uncertain, and challenges to its patents could limit its ability to commercialize drug candidates[156] - The company may face difficulties in obtaining exclusive licenses for co-owned patents, which could allow competitors to market similar products[157] - The company relies on trade secrets, know-how, and technology to protect its proprietary rights, which could be adversely affected if disclosed to competitors[158] - Success is dependent on obtaining and maintaining patents and intellectual property rights for drug candidates; failure to do so may allow competitors to commercialize similar products[159] - The uncertainties surrounding patent rights and potential litigation could materially harm the company's business, financial condition, and prospects[186] Competition and Market Risks - The company faces competition from other companies that have received Orphan Drug designations for terlipressin, which could block its approval for the orphan indication[103] - The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and high competition, which may hinder the company's ability to compete effectively[140] - The company faces significant competitive risks from other firms developing therapies for conditions related to its product candidates, such as ascites and Alzheimer's disease[144] - The timing of market introduction for the company's drug candidates compared to competitors is a crucial competitive factor[145] Management and Operational Risks - The company has limited experience in drug development, which may hinder its ability to successfully develop drugs[73] - The loss or unavailability of key management personnel could materially impact the company's business and financial condition[138] - Attracting and retaining highly skilled personnel is critical for the company's operations and expansion, and competition for such talent is intense[139] - The company lacks manufacturing experience and relies on a Contract Manufacturing Organization (CMO) for production, which poses risks if compliance with regulations is not met[122] Financial Performance - The net loss for the year ended June 30, 2024, was approximately $33.0 million, a decrease of $17.3 million compared to a net loss of $50.3 million for the year ended June 30, 2023[251] - Total operating expenses decreased to approximately $32.2 million for the year ended June 30, 2024, down from $45.1 million in 2023, reflecting a reduction of approximately $12.9 million[252] - Research and development expenses were approximately $23.1 million for the year ended June 30, 2024, down from $33.3 million in 2023, a decrease of approximately $10.2 million[253] - The company had cash and cash equivalents of approximately $23.8 million and working capital of approximately $14.7 million as of June 30, 2024[256] - The company raised approximately $9.3 million from the sale of 333,749 shares of Common Stock under the ATM Agreement during the year ended June 30, 2024[259] - The gross proceeds from the March 2024 Offering were approximately $21 million, before deducting placement agent fees and offering expenses of approximately $2.5 million[260] Stock and Shareholder Information - As of June 30, 2024, the company had 6,216,398 shares of Common Stock issued and 6,190,072 shares outstanding, allowing for the issuance of up to an additional 793,783,602 shares[206] - Acuitas beneficially owns 3,050,397 shares of Common Stock, constituting 43.2% of the issued and outstanding shares, giving it significant influence over company management and decisions[211] - The company may issue up to 1.8 million shares of Common Stock upon achieving certain clinical, regulatory, and commercial milestones related to its drug candidates, which could further dilute existing shareholders[209] - The company has outstanding warrants to purchase 1,932,029 shares at exercise prices ranging from $10.00 to $125.00 per share, and options for 518,076 shares at prices ranging from $4.74 to $420.90 per share[208] - A reverse stock split was executed on August 6, 2024, at a ratio of 1-for-10, but the impact on the market price of Common Stock remains uncertain[212] - The market price of the company's Common Stock is expected to remain volatile, influenced by various factors including financial results and market conditions[215] - The company is classified as a "smaller reporting company" with a public float of less than $250 million, which may make its stock less attractive to potential investors[220] - The company does not anticipate paying any cash dividends on its Common Stock in the foreseeable future, limiting stockholders' ability to receive returns unless they sell their shares[225] - The company has authorized the issuance of up to 10,000,000 shares of "blank check" preferred stock, which could adversely impact the rights of current Common Stock holders[226] Cybersecurity and Internal Controls - The company maintains a cybersecurity program integrated into its enterprise risk management, with oversight from the Board of Directors and the Audit Committee[231] - The company has not identified any material cybersecurity risks in the last fiscal year, but acknowledges that future incidents could materially affect its operations and financial condition[233] - The company is obligated to maintain effective internal control over financial reporting, and any deficiencies could lead to loss of investor confidence and potential regulatory scrutiny[217] - As of June 30, 2024, the company's internal control over financial reporting was evaluated as effective, providing reasonable assurance regarding the reliability of financial reporting[268] - There were no changes in internal controls over financial reporting during the quarter ended June 30, 2024, that materially affected or are likely to materially affect internal controls[269]

Company Performance - Thor Industries, Inc. reported fourth-quarter earnings per share of $1.68, exceeding the street view of $1.43, with quarterly sales of $2.534 billion, down 7.4%, surpassing the analyst consensus of $2.471 billion [2] - Thor Industries anticipates fiscal year 2025 sales between $9.0 billion and $9.8 billion, lower than the $10.49 billion estimate, and expects EPS to range from $4.00 to $5.00, below the estimated $6.65 [2] Stock Movements - Maison Solutions Inc. shares surged 115% to $1.5792 after reporting a year-over-year increase in first-quarter sales [2] - Seelos Therapeutics, Inc. shares increased 76% to $0.3356 following a material transfer agreement with the Department of Defense for a clinical trial [2] - Wave Life Sciences Ltd shares rose 53% to $8.18 after announcing interim data from its Phase 2 study for Duchenne muscular dystrophy [2] - BioVie Inc. shares fell 56% to $1.2399 after raising $3 million through a secondary offering [3] - Light & Wonder, Inc. shares dropped 18% to $92.51 after a price target reduction by Susquehanna [3] Commodity Prices - Oil prices increased by 1.3% to $71.31, gold rose by 0.9% to $2,676.60, silver increased by 4.2% to $32.385, and copper rose by 3.4% to $4.4940 [4]

Core Viewpoint - BioVie Inc. is initiating a public offering of its common stock and/or pre-funded warrants, along with accompanying common stock purchase warrants, to raise capital for working and corporate purposes [1][2]. Group 1: Offering Details - The offering will be conducted by ThinkEquity as the sole placement agent and is subject to market conditions, with no assurance on the completion or terms of the offering [2]. - The securities will be offered under a shelf registration statement on Form S-3, which was filed with the SEC and declared effective in August 2023 [3]. Group 2: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for advanced liver disease and neurological disorders [5]. - The company's drug candidate NE3107 targets neuroinflammation and insulin resistance, which are associated with Alzheimer's and Parkinson's diseases, showing promising results in clinical trials [5]. - BioVie’s orphan drug candidate BIV201 is under evaluation for treating ascites due to chronic liver cirrhosis and has received FDA Fast Track status [5].