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Parkinson’s patients elevated baseline inflammation demonstrated statistically significant improvements in both motor and non-motor symptoms with Bezisterim compared to placebo. CARSON CITY, Nev., Oct. 20, 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 the presentation of results from the Phase 2 SUNRISE-PD clinical trial evaluating bezisterim in early Parkinson’s patients at the 151st Annual Meeting of the American Neurological Association (ANA), held October 17–20, 2026, in San Diego, California. The study’s abstract was published in Annals of Neurology (Vol. 100, pp. S4–S375, ), in conjunction with the meeting. The poster , “Results of a Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Bezisterim (NE3107) in Early Parkinson's Disease (SUNRISE-PD),” presents findings from the 57-patient randomized, double-blind, placebo-controlled SUNRISE-PD trial ( NCT06757010 ). Patients received bezisterim or placebo for 12 weeks. The study assessed motor symptoms, non-motor symptoms, activities of daily living, sleep, inflammatory biomarkers, and overall clinical benefit using a Composite Benefit Score (CBS), a fit-for purpose measure designed to capture changes across multiple domains of Parkinson's disease. Patients with higher systemic inflammation at the start of the trial – defined as above-median platelet counts above 230 × 10⁹/L – demonstrated the strongest response to bezisterim. In this prespecified subgroup, which represents approximately half of the trial population, bezisterim-treated patients experienced significant improvements in the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I (non-motor) scores (-1.62 vs. +1.86 for placebo; Cohen’s d = -1.33; p=0.0124), Part III (motor) scores (-1.32 vs. +1.26; Cohen’s d = -0.92; p=0.0265), and Total Scores (-1.23 vs. +1.21; Cohen’s d = -1.45; p=0.0006). “These results provide evidence that an anti-inflammatory treatment can benefit both motor and, importantly, non-motor symptoms of Parkinson’s disease,” said Clarence Ahlem, BioVie’s Senior Vice President and Program Lead for Parkinson’s Disease. “Because non-motor symptoms remain a significant unmet need, the breadth of activity observed with bezisterim is particularly encouraging for its development as a treatment for early Parkinson’s disease. In SUNRISE-PD we observed a consistent pattern of improvement across motor symptoms, non-motor symptoms, and daily functioning, with particularly encouraging results among patients with higher baseline platelet counts, a potential marker of systemic inflammation. We believe these findings provide an important foundation for future studies and support the development of bezisterim as a treatment with the potential not only to provide symptomatic benefit, but also to impact the underlying disease process and potentially slow disease progression. In the overall modified intent-to-treat population, efficacy outcomes generally favored bezisterim across multiple measures. The CBS also demonstrated a large treatment effect favoring bezisterim (Cohen’s d = -1.61; p=0.0004). Patients receiving bezisterim were 6.25-fold more likely to achieve clinically meaningful improvement on the CBS than patients receiving placebo (25% vs 4%), corresponding to a 525% relative increase and a 21-percentage-point absolute difference. Conversely, the risk of clinically meaningful worsening was approximately 70% lower with bezisterim than with placebo (14% vs 46%; relative risk 0.30), representing a 32-percentage-point absolute risk reduction. Safety and tolerability Bezisterim was well tolerated, with a favorable safety pro with placebo. Treatment-emergent adverse events (TEAEs) occurred in 39.3% of bezisterim-treated participants and 51.7% of placebo-treated participants. No severe or serious adverse events were reported in either group, and only one potentially treatment-related adverse event was reported in each treatment arm. About Parkinson’s Disease Parkinson's disease (PD) is the second most common neurodegenerative disorder worldwide, affecting more than 10 million people, including an estimated 1.1 million people in the United States, with nearly 90,000 new diagnoses each year. 1 PD is best known for motor symptoms such as tremor, rigidity, slowed movement, and postural instability. However, PD involves neurodegeneration beyond the areas of the brain primarily associated with movement, giving rise to a broad range of non-motor symptoms, including sleep disturbances, cognitive changes, depression, anxiety, fatigue, and autonomic dysfunction. 2 Some non-motor symptoms may emerge years before a diagnosis of PD 3 and can be more troublesome and disabling than movement symptoms. 4 Non-motor symptoms are strongly associated with reduced quality of life, yet they remain frequently under-recognized and undertreated. 5 ˒ 6 The economic burden of Parkinson's disease and atypical parkinsonism in the United States was estimated at $82.2 billion in 2024, including $58.4 billion in indirect and non-medical costs, and is projected to reach $112.4 billion annually by 2045. There remains a substantial need for treatments and care that address both the motor and non-motor manifestations of PD. About the SUNRISE-PD trial SUNRISE-PD ( NCT06757010 ) was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial designed to establish proof-of-mechanism and proof-of-concept in early-stage Parkinson’s disease (PD) patients naïve to treatment with symptomatic dopaminergic therapy (carbidopa/levodopa). The study leveraged a hybrid decentralized design that lasted 20 weeks from the initial screening phase, a 12-week treatment period, through to the safety follow up. Following a screening and prospective clinical stability assessment period, 57 eligible participants were randomized 1:1 to receive either 20 mg of bezisterim or matching placebo twice daily for 12 weeks. The study prospectively evaluated a predefined battery of biologic, clinical, and quality of life assessments to assess a series of motor and non-motor endpoints and evaluate signals consistent with bezisterim’s expected metabolic and anti-inflammatory actions. The trial endpoints and planned analyses were prespecified in the final Statistical Analysis Plan (SAP) submitted to the FDA prior to data unblinding. The primary pharmacodynamic endpoint was to assess the effect of bezisterim on hematologic inflammatory biomarker indices (MLR, SIRI, NLR, SII, PLR, AISI) and a composite of those markers. Secondary and exploratory endpoints aimed to understand the pharmacodynamic, clinical, safety and tolerability, and to define the pro bezisterim versus placebo in the study population to design a potentially pivotal registrational Phase 3 trial. The study was designed to reduce common barriers to participation in PD research, including delayed diagnosis, limited mobility, geographic constraints, and access to specialized care, and allowed patients to participate either from their home or at a clinical site. At-home participants were visited by study nurses who administered a modified MDS-UPDRS Part III and standard Part I and II examinations under the supervision of a physician and MDS-UPDRS expert attending through live video link. The Part III exam was recorded for review and scoring by a central rating committee with a final expert rater review and adjudication. About Bezisterim Bezisterim (NE3107) is an investigational 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, TNFα), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease (PD), Long COVID (LC), and Alzheimer’s disease (AD). In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim demonstrated greater improvements than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms. For LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with LC. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). In AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with AD. 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 investigational drug 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 . Forward-Looking Statements This 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," “potential,” “may,” or words of similar meaning. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential for bezisterim to address unmet clinical needs in Long COVID and Parkinson’s disease; the design and conduct of future clinical trials, including a potentially pivotal Phase 3 trial; the potential clinical significance of subgroup analyses and biomarker observations; and the Company’s ability to advance bezisterim through clinical development. The clinical endpoints reported in this release are exploratory in nature. Subgroup analyses are hypothesis-generating and may not be replicated in future trials. Changes in biomarkers may not correlate with clinical benefit or support regulatory approval. The FDA has not validated these endpoints as surrogate endpoints for Long COVID. 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 risks related to the early stage of development of bezisterim and other product candidates, the possibility that results observed in this Phase 2 study of 203 patients may not be replicated in larger or longer-duration trials, the exploratory nature of subgroup analyses, 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, the possibility that clinical trial results may not be indicative of results in subsequent or larger trials, 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: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com For Media Inquiries: Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com _______________ 1 Parkinson's Foundation. Statistics. Accessed July 16, 2026. 2 Peña-Zelayeta et al. J Pers Med. 2025;15(5):172. doi:10.3390/jpm15050172. 3 Castilla-Cortázar et al. J Transl Med (2020) 18:70. 4 Parkinson's Foundation. Non-movement symptoms. Accessed July 16, 2026. 5 van der Meer et al. Expert Rev Pharmacoecon Outcomes Res . 2025;25(1):17–27. doi:10.1080/14737167.2024.2390042. 6 Chaudhuri et al. Parkinsonism Relat Disord . 2015;21(3):287–291. doi:10.1016/j.parkreldis.2014.12.031.

Phase 2 data from the ADDRESS-LC trial of Bezisterim demonstrated statistically significant improvements versus placebo across fatigue, post-exertional malaise, and objective cognitive measures in Long COVID patients with higher baseline symptom burden CARSON CITY, Nev., Oct. 19, 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 the presentation of results from the Phase 2 ADDRESS-LC study (NCT06847191) evaluating bezisterim (NE3107) in patients with Long COVID at the 151st Annual Meeting of the American Neurological Association (ANA), held October 17–20, 2026, in San Diego, California. The study’s abstract was published in Annals of Neurology (Vol. 100, pp. S4–S375, ), in conjunction with the meeting. The poster , “Results of a Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Bezisterim (NE3107) in Long COVID (ADDRESS-LC),” detailed findings from the randomized, double-blinded, placebo-controlled signal-finding ADDRESS-LC trial ( NCT06847191) . Patients (n=203) received bezisterim or placebo for 12 weeks to evaluate whether bezisterim could improve key neurological symptoms of Long COVID, including fatigue, brain fog, subjective and objective cognitive impairment, and post-exertional malaise (PEM), as well as safety and tolerability. The ADDRESS-LC trial explored 22 different measures to assess clinical outcomes to identify the clinical endpoints where bezisterim had the greatest effect and within which patient subpopulations, and no single endpoint was designated as primary. ADDRESS-LC also evaluated a series of biomarkers, and these data are pending analysis and will be presented at a future medical meeting. In the intent-to-treat population, treatment with bezisterim showed a consistent trend toward improvement across most patient-reported and objective efficacy measures compared with placebo. Importantly, analyses showed that patients with more severe baseline fatigue, post-exertional malaise (PEM), or objective cognitive impairment – symptoms affecting approximately 78% of trial participants in at least one domain – experienced the greatest benefits with bezisterim, including statistically significant improvements in multiple measures corresponding to their most pronounced symptoms. “These results highlight the substantial heterogeneity of Long COVID and suggest that baseline disease burden may play an important role in identifying patients most likely to benefit from treatment with bezisterim,” said Penelope Markham, BioVie’s Senior Vice President and Program Lead for Long COVID. “We observed a consistent and clinically meaningful pattern of improvement across measures of fatigue, post-exertional malaise, clinician- and patient-reported outcomes, and objective measures of cognition function among patients with greater baseline symptom burden. We believe these findings provide an important foundation for the design of a confirmatory Phase 3 study.” Among the most fatigued half of patients at baseline, defined as a PROMIS Fatigue T-score ≥65, mean improvement in PROMIS Fatigue at Week 12 was 8.93 points with bezisterim compared with 5.30 points with placebo (p=0.02). In this subgroup, statistically significant treatment differences favoring bezisterim were also observed for PGI-Severity Fatigue, PGI-Change Fatigue, PGI-Change Overall, and CGI-Change Overall. Among patients with high baseline PEM, defined as DSQ-PEM ≥67.5, statistically significant differences favoring bezisterim were observed in objective global cognition, processing speed, and identification/attention, as well as CGI-Change Overall, DSQ-PEM, PGI-Change Overall, and PGI-Change Fatigue. Patients with greater objective cognitive impairment at baseline, defined by a Cogstate Composite Global z-score of ≤0.130, also demonstrated statistically significant treatment differences favoring bezisterim versus placebo in objective global cognition and three cognitive domains verbal learning, verbal memory, and processing speed, as assessed using a computerized cognitive assessment tool based on Cogstate. Taken together, these findings indicate a consistent pattern in which greater baseline symptom burden was associated with larger treatment effects across multiple clinically relevant domains. Safety and tolerability Bezisterim demonstrated a safety and tolerability pro to placebo. Treatment-emergent adverse events were reported in 41.6% of patients receiving bezisterim compared with 55.9% of those receiving placebo. Drug-related treatment-emergent adverse events occurred in 18.8% and 25.5% of patients, respectively. No serious treatment-emergent adverse events were reported in the bezisterim group, while one serious event was reported in the placebo group. About Long COVID An estimated 17-20 million U.S. adults reported to be living with Long COVID, 1 with 3.8 million experiencing significant limitation to their daily lives. 2 Almost 50 percent of those with Long COVID develop persistent or intermittent symptoms. 3 The neurological and neuropsychiatric symptoms are among the most common and disabling manifestations of the condition and include fatigue, PEM, sleep disturbance, and persistent sense of difficulty with thinking and memory. 4 Chronic innate inflammation accompanied by ongoing immune dysregulation is among the leading hypotheses proposed to explain the symptoms in Long COVID, with numerous investigators describing findings in Long COVID that appear to be supportive of the intended biological targets of bezisterim. Currently, there are no FDA-approved treatment options for Long-COVID. About the ADDRESS-LC trial The Phase 2 ADDRESS-LC study ( NCT06847191 ), which is fully funded by a grant from the U.S. Department of War (DoW), is a randomized (1:1), placebo-controlled, signal-finding proof-of-concept, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with Long COVID who have cognitive impairment sequelae and fatigue. The study compared bezisterim, administered as a 20 mg oral capsule twice daily, with a matching placebo to assess its effects on neurocognitive and fatigue-related symptoms. The trial evaluated 22 clinical outcome measures, with no single endpoint pre-specified as the primary determinant of study success. Endpoints include assessing changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, Quality of Life and PEM. As a signal-finding study, the trial was designed to identify efficacy signals, measure treatment effect magnitude, and identify patient subgroups most likely to benefit, to inform the design of future Phase 3 trials. About Bezisterim Bezisterim (NE3107) is an investigational 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, TNFα), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease (PD), Long COVID (LC), and Alzheimer’s disease (AD). In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim demonstrated greater improvements than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms. For LC, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with LC. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). In AD, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with AD. Terms of the U.S. Department of War (DoW) Award The Long COVID study is supported by the Assistant Secretary of War for Health Affairs and endorsed by the DoW by a fully funded award in the amount of $13.13 million through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations in this press release are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the DoW. 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 investigational drug 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 . Forward-Looking Statements This 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," “potential,” “may,” or words of similar meaning. Forward-looking statements in this release include, but are not limited to, statements regarding: the potential for bezisterim to address unmet clinical needs in Long COVID and Parkinson’s disease; the design and conduct of future clinical trials, including a potentially pivotal Phase 3 trial; the potential clinical significance of subgroup analyses and biomarker observations; and the Company’s ability to advance bezisterim through clinical development. The clinical endpoints reported in this release are exploratory in nature. The Phase 2 ADDRESS-LC trial did not achieve statistical significance on any endpoint in the overall intent-to-treat population; statistically significant results were observed only in pre-specified subgroup analyses. Subgroup analyses are hypothesis-generating and may not be replicated in future trials. Changes in biomarkers may not correlate with clinical benefit or support regulatory approval. The FDA has not validated these endpoints as surrogate endpoints for Long COVID. 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 risks related to the early stage of development of bezisterim and other product candidates, the possibility that results observed in this Phase 2 study of 203 patients may not be replicated in larger or longer-duration trials, the exploratory nature of subgroup analyses, 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, the possibility that clinical trial results may not be indicative of results in subsequent or larger trials, 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: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com For Media Inquiries: Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com _____________________________ 1 U.S. Department of Health and Human Services ( ) 2 Bonuck et al. Commun Med. 2026;6:177. doi:10.1038/s43856-026-01516-7. 3 Thaweethai et al. Nat Commun. 2025;16(1):9557. doi:10.1038/s41467-025-65239-4. 4 Geng et al. JAMA. 2025 Feb 25;333(8):694-700. doi: 10.1001/jama.2024.24184.