CARSON CITY, Nev., Oct. 22, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (Nasdaq: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders, today announced the closing of its previously announced registered direct offering of 4,443,000 shares of its common stock priced at-the-market under Nasdaq rules at a price of $1.50 per share. In a concurrent private placem ...

Core Viewpoint - BioVie Inc. has announced a registered direct offering of 4,443,000 shares of its common stock at a price of $1.50 per share, aiming to raise approximately $6.66 million before expenses [1][2]. Group 1: Offering Details - The offering includes unregistered warrants for investors to purchase an equal number of shares at an exercise price of $1.37, exercisable six months post-issuance and expiring five years later [1][2]. - The expected closing date for the offering is around October 22, 2024, pending customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily be allocated for working capital and general corporate purposes [2]. Group 3: Company Overview - BioVie Inc. is focused on developing innovative drug therapies for chronic conditions, including neurological disorders like Alzheimer's and Parkinson's, as well as advanced liver disease [5]. - The company's drug candidate bezisterim targets neuroinflammation and insulin resistance, which are significant factors in neurodegenerative diseases [5]. - BioVie’s orphan drug candidate BIV201 is under FDA Fast Track status and is being prepared for Phase 3 clinical testing to address liver cirrhosis complications [5].

Patents covering BioVie's terlipressin liquid formulation now secured in the United States, India, Japan and Chile, and are pending in eight additional markets Liquid formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting CARSON, Nev., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Class A Common Stock, $0.0001 par value per share BIVI The NASDAQ Stock Market, LLC FORM 10-K (Mark One) ☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. FOR THE FISCAL YEAR ENDED JUNE 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ ...

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 ...

CARSON CITY, Nev., Sept. 23, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) and accompanying common stock purchase warrants in a best efforts public offering. All of the shares ...

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 ...