INSR

CARSON CITY, Nev., Sept. 23, 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 pricing of a best efforts public offering of 1,960,800 shares of its common stock (or pre-funded warrants (“Pre-funded Warrants”) in lieu thereof) and warrants to purchase up to 1,960,800 shares of common stock at a combined offering price of $1.53 per share (or Pre-funded Warrant) and associated warrant. The warrants will have an exercise price of $1.53 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. The gross proceeds to the Company from the offering are expected to be approximately $3,000,000, before deducting placement agent fees and offering expenses. The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes. All of the shares of common stock (or Pre-funded Warrants) and associated warrants are being offered by the Company. The offering is expected to close on September 25, 2024, subject to satisfaction of customary closing conditions. ThinkEquity is acting as sole placement agent for the offering. The securities were offered and will be sold pursuant to a shelf registration statement on Form S-3 (File No. 333-274083), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 18, 2023 and declared effective on August 28, 2023. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of Alzheimer’s and Parkinson’s diseases. The Company conducted and reported efficacy data on its randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) has completed, and data presented at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S Food and Drug Administration (“FDA”) Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit http://www.bioviepharma.com/. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com

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 of common stock (and/or Pre-Funded Warrants) and accompanying common stock purchase warrants are to be sold by the Company. ThinkEquity is acting as sole placement agent for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes. The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-274083), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 18, 2023 and declared effective on August 28, 2023. The offering will be made only by means of a written prospectus. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been or will be filed with the SEC on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. Before investing in this offering, interested parties should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such preliminary prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of Alzheimer’s and Parkinson’s diseases. The Company conducted and reported efficacy data from its randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate NE3107 in patients who have mild to moderate Alzheimer's disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) has completed, and data presented at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S Food and Drug Administration (“FDA”) Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit http://www.bioviepharma.com/. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com

Glucagon-like peptide 1 (GLP-1) receptor agonists (RAs) are entero-pancreatic hormone-based treatments first approved in 2005 for type 2 diabetes (T2D). They are now commonly prescribed for weight loss and reduction of atherosclerotic cardiovascular (CV) risk in patients with T2D.The health benefits and market success of GLP-1 drugs are a hot topic in todays pharmaceutical landscape. According to a MarketWatch reportfrom February 2024, the global GLP-1 market is expected to reach $471 billion by 2032.As of February 2024, there were 15 GLP-1 medications approved by the FDA for glycemic and weight control, and more were already in development.More than one billion peopleworldwide are living with obesity, which puts them at risk of major health complications, such as T2D, high blood pressure, heart disease, stroke, metabolic syndrome, fatty liver diseases, some cancers, kidney disease, breathing problems, and sleep apnea. Most of these diseases are interrelated, with glycemic control and weight loss being a major factor in improving the overall health of sufferers.We are in an era where combinations of entero-pancreatic hormones can deliver significant weight loss, and patients are experiencing health benefits well beyond blood sugar management and weight loss.As we learn more about GLP-1 RAs, we realize that they target many organ systems, including the pancreas, the stomach, brain, heart, kidneys, immune system (due to reduced inflammation), skeletal muscle, control of metabolism of both white and brown adipose tissue, and positive effect in fatty liver disease (nonalcoholic fatty liver disease and steatohepatitis; MAFLD and MASH), says Dr. Gaetano Morelli, Chief Medical Officer at Altasciences.What GLP-1 is and how receptor agonists workDr. Gaetano Morelli explains, GLP-1 is a hormone called an incretin or gut peptide released by endocrine cells in the small intestine in response to nutrient ingestion, mainly glucose and fat.Clinical data on GLP-1 RAsGLP-1 RAs mimic the action of endogenous GLP-1 and, in head-to-head clinical studies, have demonstrated that all GLP-1 RAs are effective at reducing A1C levels. These initial pivotal studies that led to the first wave of GLP-1 RAs demonstrated that they work in several ways, including stimulating insulin release, slowing digestion, reducing appetite, and inhibiting glucagon release.A guidancefrom the U.S. FDA (draft updated in March 2020) requires data on cardiovascular events in new T2D drug development programs. As a result, dedicated cardiovascular safety trials were implemented. Many demonstrated beneficial effects of GLP-1 RAs on the heart and kidneys in patients with T2D (with and without preexisting conditions), with those effects thought to be largely independent of glucose-lowering.More recently, pharmaceutical companies have sponsored large cardiovascular outcomes trials (CVOTs) to assess the beneficial effects of GLP-1 RAs on the cardiovascular system in patients with T2D, with encouraging results.What comes nextLooking to the next generation of clinical trials for obesity treatments, we see combinations of GLP-1 RAs with other entero-pancreatic hormones with complementary actions and/or synergistic potential (such as glucose-dependent insulinotropic polypeptide (GIP), glucagon, and amylin) to enhance the weight loss and cardiometabolic benefits of GLP-1 RAs. There are currently more than 140 of such compounds in development. Drug developers are also investigating the potential for longer-lasting injections.Oral formulations are another future enhancement for GLP-1 RA medicines, with several pill forms in development. Various physiological barriers, such as mucus, intestinal, and enzymatic barriers, interfere with the oral delivery or absorption of protein and peptide-based therapeutics. Thus, novel approaches such as nanocarriers, site-specific, and stimuli-specific delivery, are being used to improve the success of oral GLP-1 RAs.Sources indicate that newer GLP-1s have fewer side effects, although the most common gastrointestinal issues (nausea, vomiting, and diarrhea) may continue. Loss of muscle mass, often associated with rapid weight loss, is another potential side effect being investigated. Long-term side effects of GLP-1 usage are currently unknown, and researchers are accumulating data as this therapeutic area continues to boom.Promising programs have been halted due to challenges with side effect profiles and drug interactions, and diligent, expert program development will be critical as we move into the next generations of these important therapeutics, says Dr. Morelli. Developing newer and better GLP-1 RAs is a crucial contribution to global human health, and it is a field we at Altasciencesare proud to be advancing. '