BioVie(BIVI)
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BioVie(BIVI) - 2026 Q2 - Quarterly Report
2026-02-06 22:01
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].
BioVie hits enrolment milestone in early Parkinson's trial, data due later this year
Proactiveinvestors NA· 2026-01-16 14:27
About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...
BioVie Completes Enrollment in Phase 2 SUNRISE-PD Trial in Early Parkinson’s Disease
Globenewswire· 2026-01-08 13:00
- 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 ...
HALPER SADEH LLC ENCOURAGES BIOVIE INC. SHAREHOLDERS TO CONTACT THE FIRM TO DISCUSS THEIR RIGHTS
Prnewswire· 2025-12-24 19:05
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]
BioVie advances lead drug candidates - ICYMI
Proactiveinvestors NA· 2025-12-20 13:05
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, ...
What Makes BioVie (BIVI) a New Buy Stock
ZACKS· 2025-12-11 18:01
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].
BioVie Inc. (BIVI) Discusses Clinical Progress of Lead Drug Candidates Targeting Parkinson's, Alzheimer's, and Liver Disease Transcript
Seeking Alpha· 2025-12-10 02:27
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]
BioVie Inc. (BIVI) Discusses Clinical Progress of Lead Drug Candidates Targeting Parkinson's, Alzheimer's, and Liver Disease - Slideshow (NASDAQ:BIVI) 2025-12-09
Seeking Alpha· 2025-12-10 02:03
Group 1 - The article does not provide any specific content related to company or industry analysis [1]
Biotech Stocks Swing After Hours: Delcath Rises On Buyback, BioVie And Cassava Rebound
RTTNews· 2025-11-21 04:39
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]
Join Biovie's Exclusive Live Investor Webinar and Q&A Session on December 9
Globenewswire· 2025-11-19 13:00
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]