Core Points - BioVie is a publicly traded company on NASDAQ under the ticker BIVI [1] - The event features a presentation by Cuong Do, President and CEO of BioVie, followed by a Q&A session [1] Company Overview - BioVie is represented by Cuong Do, who is the President and CEO [3]

Group 1 - The article does not provide any specific content related to company or industry analysis [1]

Core Insights - After-hours trading on Thursday was relatively quiet, with small-cap biotech stocks showing modest movements [1] Company Summaries - **Delcath Systems, Inc. (DCTH)**: The stock rose to $8.52, up 4.02% or $0.33 after announcing a $25 million share repurchase program, reflecting confidence in its long-term outlook [2] - **BioVie Inc. (BIVI)**: The stock climbed to $1.44, a gain of 13.39% or $0.17, despite no specific news, indicating speculative or technical-driven activity [3] - **Cassava Sciences, Inc. (SAVA)**: The stock advanced to $2.87, up 9.17% or $0.24, following a narrower net loss of $10.8 million reported in Q3, compared to $27.9 million a year earlier, with $106.1 million in cash and no debt [4] - **Enlivex Therapeutics Ltd. (ENLV)**: The stock edged higher to $0.95, up 4.24% or $0.04, with no company-specific news released [5]

Core Insights - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative diseases, including Alzheimer's, Parkinson's, and Long COVID [4] - The company is hosting a webinar on December 9, 2025, featuring CEO Cuong Do, who will discuss the drug bezisterim (NE3107) and its potential benefits [2][3] - BioVie is advancing multiple late-stage clinical programs, including BIV201, an orphan drug candidate for refractory ascites, with significant market opportunities [2] Company Overview - BioVie Inc. is engaged in developing therapies targeting neuroinflammation and insulin resistance, which are critical factors in Alzheimer's and Parkinson's diseases [4] - Bezisterim is a first-in-class, orally available small molecule that has shown promising results in improving cognition and motor function in clinical studies [2][4] - BIV201, the company's late-stage candidate, is under FDA Fast Track status and aims to address complications of liver cirrhosis, with guidance from the FDA for Phase 3 clinical testing [4] Market Potential - The company is positioned to create significant value with its late-stage programs and strong safety data, targeting multi-billion-dollar market opportunities [2] - The ongoing clinical studies and potential partnerships are expected to enhance BioVie's market presence and financial performance [2]

Financial Performance - The net loss for the three months ended September 30, 2025, was approximately $5.1 million, compared to a net loss of $4.2 million for the same period in 2024, reflecting an increase of $900,000 [100]. - Total operating expenses for the three months ended September 30, 2025, were approximately $5.3 million, up from $4.1 million in 2024, representing a net increase of approximately $1.2 million [101]. - The Company reported an accumulated deficit of approximately $357.3 million as of September 30, 2025 [107]. Research and Development - Research and development expenses increased to approximately $2.9 million for the three months ended September 30, 2025, from $2.0 million in 2024, an increase of approximately $946,000 [102]. - The Phase 2 study of bezisterim for Parkinson's Disease was completed in December 2022, with 45 patients randomized in a 1:1 ratio to receive either placebo or bezisterim [92]. - The Company is finalizing the protocol design for a Phase 3 study of BIV201, targeting a broader ascites patient population [96]. - The unplanned exclusion of patients in the Alzheimer's Disease trial left it underpowered for primary endpoints, with only 81 patients remaining in the Modified Intent to Treat population [98]. Funding and Capital - The Company received a clinical trial grant of $13.1 million from the U.S. Department of Defense in April 2024 for the Long COVID program [94]. - As of September 30, 2025, the Company had working capital of approximately $24.4 million and cash and cash equivalents totaling approximately $25.0 million [107]. - The Company closed an underwritten public offering of 5,620,000 units at $2.00 per unit, resulting in net proceeds of approximately $10.5 million [110]. - An additional 380,000 pre-funded units were sold at $1.999 per unit, with each pre-funded warrant immediately exercisable [110]. - The underwriter exercised its over-allotment option, purchasing an additional 667,300 warrants [110]. - Each warrant is exercisable at an exercise price of $2.50 per share and expires five years from the date of issuance [110]. Accounting and Compliance - There were no significant changes to the Company's critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2025 [111]. - Recent accounting pronouncements were determined to be either not applicable or expected to have minimal impact on the balance sheets or statement of operations [112]. - The Company did not identify any market risk disclosures applicable to smaller reporting companies [113]. Revenue Generation - 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 [108].

Financial Data and Key Metrics Changes - The company reported a total of 7,535,080 shares of common stock issued and outstanding as of the record date [6] - Approximately 45.35% of the outstanding common stock was represented at the meeting, with 3,417,857 shares entitled to vote [21] - The Auditor Ratification Proposal received 3,245,049 votes in favor, representing approximately 86.57% of shares present or by proxy [21] Business Line Data and Key Metrics Changes - The meeting included proposals for the election of six directors and the ratification of the independent auditor, indicating a focus on governance and oversight [11][15] Market Data and Key Metrics Changes - No specific market data or key metrics changes were discussed during the meeting Company Strategy and Development Direction and Industry Competition - The company is focused on governance through the election of directors and the ratification of auditors, which is essential for maintaining investor confidence and regulatory compliance [11][15] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The 2019 Omnibus Equity Incentive Plan was amended to increase the number of shares authorized for issuance to 3 million, reflecting a strategy to incentivize employees and align their interests with shareholders [17] Summary of Q&A Session - There were no questions or answers recorded during this meeting, as the focus was primarily on voting and procedural matters

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by officers and directors of BioVie Inc., urging shareholders to contact the firm to discuss their rights and possible legal actions [1][2]. Group 1: Shareholder Rights and Legal Options - Shareholders who acquired BioVie stock on or before December 7, 2022, may seek corporate governance reforms, return of funds, court-approved financial incentives, or other benefits [2]. - The firm operates on a contingent fee basis, meaning shareholders would not incur out-of-pocket legal fees [2]. Group 2: Importance of Shareholder Participation - Active shareholder involvement can lead to improved company policies, practices, and oversight, ultimately enhancing shareholder value [3]. Group 3: Firm's Background and Experience - Halper Sadeh LLC represents global investors affected by securities fraud and corporate misconduct, having successfully implemented corporate reforms and recovered millions for defrauded investors [4].

Core Points - BioVie is a company listed on NASDAQ under the ticker BIVI, and the event features a presentation by Cuong Do, the President and CEO of BioVie [1] - The event includes a Q&A session where participants can submit questions via the Zoom platform [1] Company Overview - Cuong Do is leading the presentation for BioVie, indicating a focus on engaging with investors and stakeholders [3]

BioVie (NasdaqCM:BIVI) Update Summary Company Overview - **Company**: BioVie Inc. (Ticker: BIVI) - **Industry**: Biotechnology - **Focus**: Development of therapeutics for neurodegenerative diseases and conditions related to inflammation Key Points and Arguments Clinical Trials and Drug Development - **Parkinson's Disease Trial**: - Currently in Phase II, with enrollment expected to be completed by 2025 - Top-line data readout projected for April-May 2026 [5][7] - Drug candidate bezisterone shows promise in improving muscle control and reducing inflammation [8][15] - **Long COVID Trial**: - Phase II trial underway, with good enrollment progress - Expected to provide guidance on full enrollment within a month [6][24] - A $13 million grant received to test therapeutic effects on CNS symptoms of long COVID [28] - **Ascites Treatment**: - Phase III protocol submitted to the FDA, awaiting feedback [6][34] - Drug candidate BIV201 shows a 50% reduction in dermatitis volume in Phase 2a trial [33] - Expected annual sales for BIV201 estimated between $1.6 billion and $2 billion in the U.S. [37][40] Mechanism of Action - **Bezisterone**: - Modulates TNF alpha production, a key regulator of inflammation [8][9] - Demonstrated neuroprotective properties in preclinical studies [16][18] - Potential to address both Parkinson's and Alzheimer's diseases by reducing inflammation and improving neuronal health [71] Market Potential - **Parkinson's Market**: - Approximately 1 million patients in the U.S. - Estimated annual sales potential of $3 billion to $5 billion with 10% market penetration [36][37] - **Ascites Market**: - Significant unmet need with no current approved therapies - Estimated annual sales potential of $1.6 billion to $2 billion in the U.S. [37][40] Financial Position - **Cash Runway**: - Sufficient cash to fund operations through 2026, covering the timelines for ongoing trials [7][38] - Actively seeking to raise $25 million to fund Phase III trials for ascites [35] Regulatory and Legal Considerations - **FDA Interaction**: - Anticipated to receive no comments on the Phase III protocol for ascites, allowing progression to the next trial phase [40] - **Class Action Lawsuit**: - Currently in the discovery phase, not seen as a significant drain on resources [60][61] Strategic Partnerships - **Pharmaceutical Partnerships**: - Ongoing discussions with major pharmaceutical companies, with interest in the novel mechanism of action [56] - Expectation to out-license or be acquired upon demonstrating positive trial data [56] Additional Insights - **Long COVID Awareness**: - Significant number of Americans suffering from long COVID, with no effective treatments currently available [24][25] - **Market Dynamics**: - The biotechnology sector has faced challenges in capital raising, but there are signs of improvement [46][47] - **Future Development**: - Plans to develop a once-daily formulation of bezisterone post-trial completion [48][49] This summary encapsulates the critical developments and strategic outlook for BioVie, highlighting its innovative approaches to treating significant health conditions and the potential market opportunities that lie ahead.

Core Insights - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative diseases, including Alzheimer's, Parkinson's, and long COVID [4] - The company will host an investor webinar on October 8, 2025, featuring CEO Cuong Do discussing their drug candidate bezisterim (NE3107) and the late-stage orphan drug BIV201 [2][3] Company Overview - BioVie Inc. is developing bezisterim, an orally available small molecule targeting inflammation and insulin resistance, which are key drivers of Alzheimer's, Parkinson's, and long COVID [2][4] - BIV201 is a late-stage orphan drug candidate for refractory ascites, a complication of liver cirrhosis, currently with no FDA-approved therapies [2][4] - The company has received FDA Fast Track status for BIV201 and is in discussions regarding the design of Phase 3 clinical testing [4] Clinical Development - Clinical studies for bezisterim have shown promising results in improving cognition, motor function, and reducing neuroinflammation [2] - BioVie is advancing several late-stage clinical programs and evaluating potential partnerships in markets with significant commercial potential [3]