Biovie Inc Stock Price, News & Analysis

BioVie Inc. (NASDAQ: BIVI), a clinical-stage company developing drug therapies for liver disease and neurological disorders, has announced the pricing of a public offering. The offering includes 1,960,800 shares of common stock (or pre-funded warrants) and warrants to purchase up to 1,960,800 shares at a combined price of $1.53 per share and associated warrant. The warrants have an exercise price of $1.53 and will be exercisable for five years upon issuance.

The company expects to raise approximately $3,000,000 in gross proceeds, which will be used primarily for working capital and general corporate purposes. The offering is set to close on September 25, 2024, subject to customary closing conditions. ThinkEquity is acting as the sole placement agent for this best efforts public offering.

BioVie Inc. (NASDAQ: BIVI), a clinical-stage company focused on developing innovative drug therapies for advanced liver disease and neurological disorders, has announced its intention to conduct a public offering of common stock shares and accompanying purchase warrants. The company may also offer pre-funded warrants in lieu of common stock. ThinkEquity is acting as the sole placement agent for this best efforts offering.

The offering's proceeds are intended primarily for working capital and general corporate purposes. The securities will be offered under a shelf registration statement filed with the SEC. A preliminary prospectus supplement and accompanying prospectus will be available from ThinkEquity and the SEC's website. The offering's completion is subject to market conditions, with no guarantees regarding its execution or terms.

BioVie Inc. (NASDAQ: BIVI) has secured all scientific approvals needed to receive an additional $12.6 million in grant funding from the U.S. Department of Defense for a planned Phase 2 trial of bezisterim in long COVID. The U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO) approved BioVie's plan to evaluate bezisterim for treating neurological symptoms associated with long COVID. This approval follows the FDA's Safe to Proceed designation in August 2024.

The Phase 2 study, expected to commence by early 2025, will be a randomized, placebo-controlled trial involving approximately 200 patients to assess the safety, tolerability, and potential efficacy of bezisterim in reducing neurocognitive symptoms of long COVID over a 3-month treatment period. Bezisterim, which can cross the blood-brain barrier, targets inflammation via NF-kB activation, addressing a suspected underlying cause of long COVID symptoms.

BioVie Inc. (NASDAQ: BIVI) has received FDA authorization for its Investigational New Drug (IND) application to evaluate bezisterim in a Phase 2 trial for treating neurological symptoms associated with long COVID. This milestone puts BioVie on track to receive an additional $12.6 million in grant funding from the U.S. Department of Defense and initiate the trial. The planned study will be a randomized, placebo-controlled, multicenter trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over a 3-month treatment period.

Long COVID affects about 5.5% of U.S. adults, with approximately 3.6 million people reporting significant activity modifications due to the illness. Bezisterim's potential to modulate inflammation by activating NF-kB and its ability to permeate the blood-brain barrier make it a promising candidate for addressing the underlying mechanisms of long COVID symptoms.

BioVie Inc. (NASDAQ: BIVI) presented clinical data on bezisterim at the 11th Aging Research and Drug Discovery Meeting, revealing its potential to modulate inflammation and the biological aging process. Key findings include:

1. Patients treated with bezisterim experienced a 2-4 year age deceleration advantage compared to placebo.

2. Bezisterim modulated DNA methylation of proinflammatory genes and appeared to promote the transition of M1 proinflammatory to M2 anti-inflammatory macrophages.

3. The drug was associated with a 1.5 to 2.3 'fold enrichment' on gene control for hundreds of genes in pathways linked to neurodegenerative disorders and biological processes.

These results suggest bezisterim's potential to impact various age-related diseases and inflammation-related conditions.

BioVie Inc. (NASDAQ: BIVI) announced a poster presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) in Copenhagen, Denmark. The presentation, titled 'Bezisterim Effects on Biological Age, Alzheimer's Epigenetics, and Neurologic Assessments', will showcase clinical data on bezisterim, focusing on its potential impact on longevity and the biological aging process.

Christopher L. Reading, BioVie's Senior VP of Alzheimer's Disease Program, will deliver the presentation on August 27, 2024. The company aims to highlight bezisterim's effects on biological age, gene expression, and measures of aging-related diseases. Detailed data and conclusions will be announced after the public presentation at the conference.

BioVie Inc. (NASDAQ: BIVI) has announced alignment with the FDA for its SUNRISE-PD trial to evaluate bezisterim (NE3107) in Parkinson's disease. The trial will assess the drug's effect on motor and non-motor symptoms in approximately 60 patients naive to carbidopa/levodopa. The FDA recommended including the MDS-UPDRS Part II score as a primary endpoint, which is already part of the trial design as a secondary endpoint. BioVie plans to initiate patient screening in Q4 2024. This Phase 2 study aims to explore bezisterim's impact on newly diagnosed patients, complementing earlier trials and potentially establishing its applicability for the entire Parkinson's patient population.

BioVie Inc. (NASDAQ: BIVI) has announced the implementation of a 1-for-10 reverse stock split of its issued and outstanding Class A common stock, effective August 6, 2024. The company's shares began trading on a split-adjusted basis on the same day, maintaining its listing on The Nasdaq Capital Market under the symbol "BIVI". This action follows the approval by BioVie stockholders at a Special Meeting held on July 29, 2024. The reverse split aims to adjust the company's share structure, potentially impacting its market capitalization and share price. Investors can find detailed information about the Special Meeting in the company's definitive proxy statement filed with the SEC on June 17, 2024, available on the SEC website and BioVie's corporate website.

BioVie (Nasdaq:BIVI) and bioAffinity Technologies (Nasdaq:BIAF) will appear on the RedChip Small Stocks, Big Money show on Bloomberg TV on July 6 at 7 p.m. ET. Cuong Do, President and CEO of BioVie, will discuss their late-stage clinical programs for neurodegeneration and liver disease. BioVie's lead asset, bezisterim, has shown promise in treating Parkinson's and Alzheimer's diseases by reducing inflammation, improving motor control, cognition, and brain imaging. BioVie plans to launch a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.

Maria Zannes, President and CEO of bioAffinity Technologies, will provide a corporate update, highlighting CyPath Lung's success in early-stage lung cancer detection. The test has demonstrated high sensitivity and specificity, with commercialization already underway. The lung cancer screening market is projected to hit $5.7 billion by 2030. bioAffinity's AI-enhanced flow cytometry platform is also being developed for COPD and asthma diagnosis. The company holds extensive patents and is backed by strong insider ownership (39%).