BioVie, Inc. - BIVI STOCK NEWS

BioVie Inc. (NASDAQ: BIVI) has received a Notice of Allowance from the USPTO for a patent application covering a novel liquid formulation of terlipressin acetate. This formulation demonstrates room-temperature stability for up to 24 months and can be packaged in a pre-filled syringe. The patent is expected to be listed in the Orange Book and supports BioVie's development of a more patient-centric ambulatory treatment for patients with ascites and hepatic failure.

The liquid formulation offers significant advantages over the recently approved lyophilized powder form of terlipressin in the US, which requires reconstitution and refrigerated storage. BioVie's formulation could improve dosing convenience and safety, particularly in home-care settings. The company has also secured patents for this formulation in India and Chile, with applications pending in nine additional markets.

BioVie Inc. (Nasdaq: BIVI), a clinical-stage company developing therapies for liver disease and neurological disorders, has closed its previously announced public offering. The offering included 1,360,800 shares of common stock, 600,000 pre-funded warrants, and warrants to purchase up to 1,960,800 shares at a combined price of $1.53 per share or pre-funded warrant with associated common warrant. The common warrants have an exercise price of $1.53 and are exercisable for five years. The offering raised approximately $3,000,000 in gross proceeds. BioVie plans to use the net proceeds for working capital and general corporate purposes. ThinkEquity acted as the sole placement agent for this best efforts offering, which was conducted under a shelf registration statement filed with the SEC.

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.