CARSON CITY, Nev., Feb. 23, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, is pleased to invite investors to a webinar on March 4, 2026, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Cuong Do, President and CEO of BioVie, who will discuss BioVie’s investigational drug candidate bezisterim (NE3107), a first-in-class, orally availabl ...

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - BioVie Inc. announced the acceptance of two abstracts for its lead candidate bezisterim (NE3107) at the 2026 American College of Psychiatrists annual meeting, focusing on Alzheimer's Disease and Long COVID [1][2]. Group 1: Bezisterim Overview - Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier, aiming to reduce inflammation and improve insulin sensitivity without immune suppression and with low drug-drug interaction risk [3]. - The drug targets neuroinflammation pathways (ERK, NFκB, TNF-α) and has potential applications in Parkinson's disease, Long COVID, and Alzheimer's disease [3]. Group 2: Clinical Trials and Results - In Parkinson's disease, a completed Phase 2 study indicated that patients taking bezisterim with levodopa experienced better motor control and fewer morning symptoms compared to those on levodopa alone, with minimal side effects [4]. - The SUNRISE-PD trial is currently enrolling 60 patients to assess bezisterim's efficacy in improving symptoms for untreated Parkinson's patients, with topline results expected in mid-2026 [4]. - The ADDRESS-LC trial is enrolling around 200 patients to evaluate bezisterim's ability to alleviate neurological symptoms associated with Long COVID, with topline data anticipated in mid-2026 [5]. - In Alzheimer's disease, both Phase 2 and Phase 3 trials have been conducted, showing early results that suggest cognitive improvements and biomarker support for further trials [6]. Group 3: Company Background - BioVie Inc. is a clinical-stage biopharmaceutical company focused on therapies for neurological disorders and advanced liver disease, with bezisterim targeting neuroinflammation and insulin resistance [7]. - The company is also advancing BIV201, a treatment for liver disease that has received FDA Orphan and Fast Track designations, and plans to conduct a Phase 3 trial for its efficacy in patients with cirrhosis and ascites [8].

Core Insights - BioVie Inc is focusing on addressing the root causes of neurodegeneration, particularly in Parkinson's disease, rather than just treating symptoms [1][4][12] Company Overview - BioVie Inc is a clinical-stage biopharmaceutical company with a market capitalization in the tens of millions [1] - The company is advancing bezisterim (NE3107), an oral small-molecule drug aimed at blocking TNF alpha mediated inflammation and reversing insulin resistance [2] Parkinson's Disease Focus - Parkinson's disease affects approximately one million people in the U.S., with prevalence expected to rise as the population ages [3] - Current treatments, primarily Levodopa, do not slow neurodegeneration and can lead to involuntary movements [3] - BioVie posits that Parkinson's symptoms arise from low dopamine levels and chronic inflammation due to insulin resistance [4] Clinical Trials and Data - BioVie has completed enrollment in the SUNRISE-PD trial, evaluating bezisterim in 60 early-stage Parkinson's patients not yet on levodopa therapy [6] - The trial aims to determine if bezisterim can delay motor decline, differentiating it from existing treatments [6] - Topline data from the SUNRISE-PD trial is expected in April or May 2026, marking a significant catalyst for the company [7] Broader Implications of Bezisterim - Beyond Parkinson's, bezisterim is also being studied for long COVID and Alzheimer's disease, where chronic inflammation plays a role [8] - A 200-patient trial for long COVID is underway, supported by a $13 million non-dilutive grant [8] Additional Clinical Asset - BioVie is also advancing BIV201, targeting ascites associated with late-stage liver disease, with a Phase 2 trial showing over 50% reduction in fluid buildup [9] - The program has received FDA clearance to proceed directly into a Phase 3 study under orphan and fast-track designations [9] Market Position and Investment Outlook - Despite a broad clinical portfolio, BioVie’s valuation remains modest, attributed to market skepticism towards early-stage biotech [10] - The company presents a high-risk, high-reward investment opportunity with multiple catalysts expected in the next 12 to 18 months [11] - 2026 is anticipated to be a significant year for the company, with potential for substantial market impact if clinical data supports its hypotheses [11][12]

Financial Performance - The net loss for the three months ended December 31, 2025, was approximately $6.1 million, a decrease from the net loss of approximately $7.1 million for the same period in 2024, reflecting a reduction of $1.0 million [109]. - The net loss for the six months ended December 31, 2025, was approximately $11.2 million, comparable to the net loss of approximately $11.3 million for the same period in 2024 [115]. - For the six months ended December 31, 2025, the Company reported total revenue of approximately $4.9 million, an increase of $818,000 compared to $4.1 million for the same period in 2024 [119]. Operating Expenses - Total operating expenses for the three months ended December 31, 2025, were approximately $6.3 million, down from $7.3 million in 2024, indicating a decrease of approximately $1.0 million [110]. - Total operating expenses for the six months ended December 31, 2025, were approximately $11.5 million, slightly up from $11.4 million in 2024 [116]. - General and administrative expenses decreased to approximately $4.2 million for the six months ended December 31, 2025, down from $4.6 million in 2024, primarily due to reductions in stock-based compensation and consultancy fees [120]. - Legal fee expenses increased by approximately $546,000, primarily related to class action litigation [120]. Research and Development - Research and Development (R&D) expenses were approximately $4.3 million for the three months ended December 31, 2025, compared to $4.7 million in 2024, a decrease of approximately $435,000 attributed to reduced expenses in Long COVID studies [111]. - R&D expenses for the six months ended December 31, 2025, were approximately $7.2 million, an increase of approximately $511,000 from $6.7 million in 2024, driven by increased study costs [117]. - The increase in clinical study costs of approximately $818,000 was primarily due to the Sunrise PD Phase 2 study, which cost approximately $2.3 million [118]. - The Sunrise PD Phase 2 study incurred costs of approximately $2.6 million for the three months ended December 31, 2025, an increase of $1.5 million from $1.2 million in 2024 [112]. - Bezisterim (NE3107) is being tested for its potential to treat Alzheimer's disease, with significant data analysis ongoing from a Phase 3 clinical trial [105]. Funding and Financial Position - The Company received a clinical trial grant of $13.1 million from the U.S. Department of Defense for the Long COVID program, which commenced in May 2025 [101]. - The Company raised approximately $10.5 million in net proceeds from a public offering that closed on August 11, 2025, selling 5,620,000 units at $2.00 per unit [125]. - As of December 31, 2025, the Company had working capital of approximately $18.8 million and cash and cash equivalents totaling approximately $20.5 million [122]. - The Company has an accumulated deficit of approximately $363.3 million as of December 31, 2025 [122]. - The Company faces substantial doubt regarding its ability to continue as a going concern due to uncertainties in obtaining sufficient financing [124]. Accounting Policies - 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 [126]. Other Income - Other income increased to approximately $390,000 for the six months ended December 31, 2025, compared to $150,000 in 2024, driven by a reduction in interest expense of approximately $315,000 [121]. 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 commercialization efforts for future operations [123].

Company Overview - Proactive is a financial news and online broadcast organization that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates across six offices on three continents, including key financial hubs such as London, New York, Toronto, Vancouver, Sydney, and Perth [2] Content Production - Proactive's editorial team produces approximately 50,000 pieces of real-time news, feature articles, and filmed interviews annually [1] - The content covers a wide range of topics, including medium and small-cap markets, blue-chip companies, commodities, biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

Core Viewpoint - BioVie Inc. has completed enrollment of 60 patients in its Phase 2 SUNRISE-PD clinical trial, which aims to evaluate the efficacy of bezisterim in delaying disease progression in early-stage Parkinson's disease patients [2][5]. Group 1: Clinical Trial Details - The SUNRISE-PD trial is designed to assess the safety and efficacy of bezisterim on both motor and non-motor symptoms in patients diagnosed with Parkinson's disease within the past four years [3][7]. - The trial employs a hybrid, decentralized design to enhance participation by addressing barriers such as delayed diagnosis and geographic constraints, allowing participants to complete visits at home or in a clinic [3][4]. - Topline results from the SUNRISE-PD trial are expected in the first half of 2026 [1][5]. Group 2: Drug Profile and Mechanism - Bezisterim (NE3107) is an oral drug that targets neuroinflammation and insulin resistance, which are believed to contribute to the progression of Parkinson's disease and other neurodegenerative conditions [6][10]. - Previous clinical trials indicated that bezisterim, when combined with levodopa/carbidopa, improved motor control and reduced symptoms in Parkinson's patients, with a favorable safety profile [4][7]. Group 3: Broader Implications and Future Trials - BioVie is also exploring bezisterim for other conditions, including Long COVID and Alzheimer's disease, with ongoing trials expected to yield results in mid-2026 [8][9]. - The company emphasizes the importance of accessible clinical trials for Parkinson's disease, reflecting strong engagement from the patient community and advocacy organizations [4][5].

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]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - BioVie Inc. (BIVI) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][2]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are closely correlated with near-term stock price movements [3]. - Institutional investors often rely on earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [3]. Business Improvement Indicators - The increase in earnings estimates and the Zacks rating upgrade for BioVie suggest an improvement in the company's underlying business, which could lead to higher stock prices as investors respond positively [4]. Importance of Earnings Estimate Revisions - Research indicates a strong correlation between earnings estimate revisions and stock movements, making it beneficial for investors to track these revisions [5]. - The Zacks Rank system effectively utilizes earnings estimate revisions to classify stocks, providing a structured approach for investment decisions [6]. Specific Earnings Estimates for BioVie - For the fiscal year ending June 2026, BioVie is expected to earn -$2.95 per share, which remains unchanged from the previous year [7]. - Over the past three months, the Zacks Consensus Estimate for BioVie has increased by 2.3% [7]. Zacks Rating System Overview - The Zacks rating system maintains a balanced distribution of "buy" and "sell" ratings across its universe of over 4,000 stocks, with only the top 5% receiving a "Strong Buy" rating [8]. - BioVie’s upgrade to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [9].