- Patient-centric trial aiming to evaluate whether bezisterim can help delay disease progression reaches enrollment milestone - - Topline Results from the SUNRISE-PD Trial Expected in 1H 2026 - CARSON CITY, Nev., Jan. 08, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that it has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical ...

Core Viewpoint - Halper Sadeh LLC is investigating potential breaches of fiduciary duties by certain officers and directors of BioVie Inc. (NASDAQ: BIVI) towards shareholders [1] Group 1: Shareholder Rights and Legal Options - Long-term shareholders of BioVie may seek corporate governance reforms, return of funds, court-approved financial incentives, or other benefits [2] - Shareholder involvement is crucial for improving company policies and practices, leading to enhanced shareholder value [3] Group 2: Firm's Background and Services - Halper Sadeh LLC represents global investors affected by securities fraud and corporate misconduct, having recovered millions for defrauded investors [4]

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

BioVie Inc. (BIVI) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The power of a changing ...

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]

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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