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]

U.S. stocks traded mixed toward the end of trading, with the Dow Jones index edging lower on Tuesday. The Dow traded down 0.04% to 42,109.03 while the NASDAQ rose 0.51% to 18,065.98. The S&P 500 also rose, gaining, 0.14% to 5,726.56. Check This Out: How To Earn $500 A Month From Nvidia Stock Leading and Lagging Sectors Materials shares jumped by 1.2% on Tuesday. In trading on Tuesday, financials shares fell by 1.1%. Top Headline Thor Industries, Inc. THO reported better-than-exp earnings for its fourth quar ...

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].

Core Viewpoint - BioVie Inc. has received approval from the U.S. Army Medical Research and Development Command for its plan to evaluate bezisterim for treating neurological symptoms associated with long COVID, which is a significant step towards receiving $12.6 million in grant funding and initiating Phase 2 trials by early 2025 [1][2]. Group 1: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease [10]. - The company's drug candidate, bezisterim, is an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties [7][8]. - Bezisterim is also being investigated for Alzheimer's disease and Parkinson's disease, with positive efficacy data reported from previous trials [9]. Group 2: Long COVID Context - Long COVID affects over 17 million adults in the U.S., with symptoms persisting for three months or more, including cognitive dysfunction and fatigue [3][5]. - Chronic inflammation is a key hypothesis for the persistence of long COVID symptoms, with specific physiological features such as blood-brain barrier dysfunction being significant [6]. - Bezisterim targets inflammation and BBB integrity, potentially addressing the underlying causes of long COVID symptoms [8][6]. Group 3: Clinical Trial Details - The planned Phase 2 study will be a randomized, placebo-controlled trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over three months [2]. - The study aims to evaluate the reduction of neurocognitive symptoms associated with long COVID [2]. - The Department of Defense has allocated $499,200 for the planning phase, with the potential for an additional $12.6 million to initiate the clinical trial [4].

Core Viewpoint - BioVie Inc. has received FDA authorization for its IND application to evaluate bezisterim for treating neurological symptoms associated with long COVID, marking a significant milestone ahead of schedule [1][2]. Group 1: Company Developments - BioVie is set to receive an additional $12.6 million in grant funding from the U.S. Department of Defense to initiate a Phase 2 trial for bezisterim [1][4]. - The planned Phase 2 study will involve approximately 200 patients in a randomized, placebo-controlled trial to assess the safety and tolerability of bezisterim over three months [2]. Group 2: Long COVID Overview - Long COVID affects approximately 5.5% of U.S. adults, with around 3.6 million individuals reporting significant modifications to their daily activities due to the condition [3][5]. - Symptoms of long COVID include cognitive dysfunction and fatigue, with chronic inflammation being a key hypothesis for the persistence of these symptoms [3][6]. Group 3: Bezisterim Details - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable drug that acts as an insulin-sensitizer and anti-inflammatory, potentially reducing long COVID symptoms [7]. - The drug has shown promise in modulating inflammation through the activation of NF-kB, targeting underlying causes of long COVID symptoms [7]. Group 4: Broader Implications - The economic impact of long COVID is substantial, estimated at $3.7 trillion due to loss in quality of life, earnings, and increased medical costs [5]. - Bezisterim is also being investigated for its efficacy in treating Alzheimer's disease and Parkinson's disease, with positive results reported in clinical trials [8].

Core Insights - Bezisterim demonstrates significant potential in modulating biological aging and inflammation, showing a 2 to 4 years age deceleration advantage in patients compared to placebo [1][3][11] Group 1: Clinical Data and Findings - Clinical data presented at the 11th Aging Research and Drug Discovery Meeting indicates that bezisterim affects biological aging and chronic low-grade inflammation [2][3] - Patients treated with bezisterim exhibited age deceleration advantages across various biological clocks: 3.68 years on SkinBlood Clock, 4.77 years on Inflammation Age Clock, 5.0 years on Hannum Age Clock, 1.92 years on GrimAge Clock, and 3.71 years on PhenoAge Clock [3][11] - Bezisterim is associated with 1.5 to 2.3 "fold enrichment" in gene pathways related to neurodegenerative disorders, indicating its potential to influence gene expression significantly [4][9] Group 2: Mechanism of Action - Bezisterim modulates DNA methylation of proinflammatory genes, promoting the transition from M1 proinflammatory macrophages to M2 anti-inflammatory macrophages [1][3][9] - The drug has shown the ability to significantly modulate the methylation levels of genes involved in inflammatory pathways, potentially reducing the production of inflammatory factors such as TNFα and IL6 [4][9][10] - Bezisterim is believed to be the first drug candidate to demonstrate an impact on DNA methylation and age deceleration in a clinical trial context [3][5] Group 3: Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease [12] - The company is investigating bezisterim for conditions such as Alzheimer's disease and Parkinson's disease, with promising results from Phase 2 and Phase 3 clinical trials [11][12] - BioVie is also developing BIV201, an orphan drug candidate for treating ascites due to chronic liver cirrhosis, which has received FDA Fast Track status [12]

CARSON CITY, Nev., Aug. 06, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or the "Company") today announced that the Company's reverse stock split of its issued and outstanding Class A common stock ("Common Stock"), at an exchange ratio of 1-for-10, is now effective. The Company's Common Stock began trading on a split-adjusted basis and will remain listed on The Nasdaq Capital Market under the symbol "BIVI". The new CUSIP number for the Company's Common Stock following the reverse stock spli ...

Core Points - BioVie Inc. has executed a reverse stock split of its Class A common stock at a ratio of 1-for-10, effective immediately [1][2] - The company's common stock will continue to trade on The Nasdaq Capital Market under the symbol "BIVI" with a new CUSIP number of 09074F405 [1] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, as well as advanced liver disease [3] - The drug candidate bezisterim targets neuroinflammation and insulin resistance, which are associated with Alzheimer's disease (AD) and Parkinson's disease (PD) [3] - The orphan drug candidate BIV201, which has received FDA Fast Track status, is being evaluated for the treatment of ascites due to chronic liver cirrhosis [3] - BIV201 is already approved in the U.S. and approximately 40 other countries for related complications of advanced liver cirrhosis [3]

Core Viewpoint - BioVie Inc. is advancing its clinical-stage drug candidate bezisterim (NE3107) for the treatment of Parkinson's disease, with a focus on both motor and non-motor symptoms, as highlighted in recent presentations at the ATMRD Congress [1][2][3]. Study Design and Objectives - The upcoming SUNRISE-PD trial is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate bezisterim in approximately 60 patients with early Parkinson's disease who have had minimal prior exposure to carbidopa/levodopa [4][5]. - The trial will last 20 weeks, including a 12-week double-blind phase where patients will be randomized to receive either bezisterim 20 mg or placebo twice daily [4][10]. Key Endpoints - The primary objective is to evaluate the efficacy of bezisterim in treating motor symptoms, specifically measuring changes in the MDS-UPDRS Part III score at week 12 [6][8]. - Secondary objectives include assessing the impact on non-motor symptoms, overall symptoms, and safety and tolerability of bezisterim [6][7][10]. Previous Trial Data - Data from a Phase 2a trial indicated that bezisterim, when used adjunctively with carbidopa/levodopa, showed improvements in both motor and non-motor symptoms of Parkinson's disease [11][12]. - Patients treated with bezisterim experienced a statistically significant improvement in MDS-UPDRS Part III scores compared to placebo, particularly in patients younger than 70 years [12][13]. Mechanism of Action - Bezisterim is characterized as an orally bioavailable, BBB-permeable insulin-sensitizer with anti-inflammatory properties, potentially addressing inflammation and insulin resistance associated with Parkinson's disease [15][17]. Broader Implications - The ongoing research into bezisterim also includes investigations for Alzheimer's disease, with previous studies showing promising results in cognitive function and biomarker levels [16][17].

CARSON CITY, Nev., June 20, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) ("BioVie" or the "Company") a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced two poster presentations at the Advanced Therapeutics in Movement and Related Disorders Congress® (ATMRD Congress) being held June 21-25, 2024 in Washington, D.C. The presentation Assessment of Bezisterim (NE3107) in Patients with ...