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- 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 trial evaluating the safety and efficacy of bezisterim (NE3107) on motor and non-motor symptoms in individuals with early-stage Parkinson’s disease (PD) who have not been treated with carbidopa/levodopa. SUNRISE-PD explores whether bezisterim can affect the progression of Parkinson’s symptoms in patients diagnosed with PD within the past four years who need treatment for their symptoms. The trial uses a hybrid, decentralized Phase 2 trial designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care. The study’s flexible design allows participants to complete their study visits either at home or in a clinic, improving access and flexibility while maintaining rigorous data quality and centralized oversight. Completion of enrollment for SUNRISE-PD reflects strong engagement from the PD community and highlights the feasibility of patient-centric trial designs in PD research. “We are looking to see how bezisterim treatment may affect symptomatic progression for Parkinson’s disease patients needing treatment for the first time,” said Cuong Do, President and CEO of BioVie Inc. “Completing enrollment in SUNRISE-PD is an important milestone for BioVie and a testament to the need for more accessible and inclusive clinical trials for people with Parkinson’s disease This milestone benefited from the strong engagement of the Parkinson’s disease community, and we look forward to advancing SUNRISE-PD toward topline data and continuing our mission to develop a potentially disease-modifying treatment for people living with Parkinson’s disease.” Bezisterim is an anti-inflammatory and insulin-sensitizing agent being developed for PD and other neurodegenerative diseases including Alzheimer’s disease (AD) and Long COVID (LC), all conditions where inflammation contributes to neurological damage. In previous clinical trials of PD, bezisterim was administered in combination with levodopa/carbidopa and demonstrated improvements in both motor and non-motor symptoms with a favorable safety profile. It is designed to target key biological processes believed to contribute to the progression of PD, with the goal of modifying the course of the condition over time. SUNRISE-PD enrolled individuals ages 41 to 80 who were diagnosed with PD within the past four years and had not been treated with carbidopa/levodopa. BioVie supported enrollment through outreach and awareness efforts with the support of leading advocacy organizations in the PD field, including The Michael J. Fox Foundation , Davis Phinney Foundation , and the Parkinson’s Foundation . Now that participant enrollment is complete, the Company anticipates analyzing and reporting top-line results first half of 2026. About Bezisterim Bezisterim (NE3107) is an oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In Parkinson’s disease, BioVie has already completed a Phase 2 study that showed patients with moderate- to severe Parkinson’s taking bezisterim with levodopa had better motor control and fewer morning symptoms compared to those taking levodopa alone. Few drug-related side effects were observed. The current SUNRISE-PD just completed enrolling 60 patients to evaluate whether bezisterim alone can help improve motor and non-motor symptoms for Parkinson’s patients who have not been treated with carbidopa/levodopa. Topline results are expected in mid‑2026. For Long COVID, the ADDRESS-LC trial is enrolling about 200 patient to evaluate if bezisterim can reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long Covid, which are believed to be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). Topline data is expected mid-2026. In Alzheimer’s disease, BioVie has conducted both Phase 2 and Phase 3 trials. Early results suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for long COVID, where persistent inflammation is thought to underlie symptoms such as brain fog and fatigue. In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit . For Investor Relations Inquiries: For Media Inquiries: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com

Aug. 07, 2025 -- BioVie Inc. (NASDAQ: BIVI, BIVIW), (“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 its underwritten public offering of 6,000,000 units, with each unit consisting of one share of common stock and one warrant (the “Warrants”) (or pre-funded units in lieu thereof, with each pre-funded unit consisting of one pre-funded warrant (the “Pre-Funded Warrants”) and one Warrant). Each unit is being sold to the public at a price of $2.00 per unit (and each pre-funded unit is being sold to the public at the public offering price of each unit less the $0.0001 per share nominal exercise price for each Pre-Funded Warrant). The gross proceeds to the Company from this offering are expected to be approximately $12 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The Warrants included in the units and pre-funded units have been approved for listing on the Nasdaq Capital Market and are expected to commence trading under the symbol “BIVIW” on August 8, 2025. Each Warrant will be immediately exercisable, will entitle the holder to purchase one share of common stock at an exercise price of $2.50 per share and will expire five years from the date of issuance. Each Pre-Funded Warrant will be immediately exercisable, will entitle the holder to purchase one share of common stock and may be exercised at any time until exercised in full. The common stock (or Pre-Funded Warrants in lieu thereof) and Warrants can only be purchased together in the offering but will be issued separately. The Company has granted the underwriter a 45-day option to purchase up to an additional 900,000 shares of common stock and/or Pre-Funded Warrants and/or Warrants, or any combination thereof, solely to cover over-allotments, if any, at the public offering price, less underwriting discounts and commissions. The Company intends to use the proceeds for working capital and general corporate purposes. The offering is expected to close on August 11, 2025, subject to satisfaction of customary closing conditions. ThinkEquity is acting as sole book-running manager for the offering. A registration statement on Form S-1, as amended (File No. 333-288525), relating to the securities was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on August 7, 2025. This offering is being made only by means of a preliminary prospectus forming a part of the registration statement and a final prospectus. The registration statement and the preliminary prospectus relating to the offering are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus, when available, may be obtained from 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. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders Alzheimer's disease (AD) and Parkinson’s disease (PD) and LongCovid (LC) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor, Nuclear factor- kB, and the associated neuroinflammation and insulin resistance but not ERK and NFkB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of AD and PD. Persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of Long COVID.In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with 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 reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. The content above comes from the network. if any infringement, please contact us to modify.