TLR4

Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone needed for Company to receivebulk of $13.1 million grant funding Company anticipates Phase 2 trial to commence by early 2025 CARSON CITY, Nev., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the U.S. Army Medical Research and Development Command, Office of Human Research Oversight, (OHRO) has approved BioVie’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. FDA had previously reviewed and approved the study as Safe to Proceed in August 2024. Approval from OHRO is the last scientific review milestone needed for the Company to receive the additional $12.6 million in grant funding from the U.S. Department of Defense (DOD) and initiate Phase 2 testing in long COVID. The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with long COVID. Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that more than 17 million adults in the United States currently or previously had long COVID.1 Symptoms include cognitive dysfunction and fatigue and are debilitating. No therapies have proven effective for treatment to date. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting a suspected underlying cause of long COVID symptoms. Terms of the Department of Defense AwardThe work is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with the option, if approved, to receive an additional $12.6 million, to initiate a clinical trial once the planning phase has concluded and milestones have been met, through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. About Long COVIDLong COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, hearing loss, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously have long COVID.1 The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be $3.7 trillion.2 To date there are no non-pharmacological or pharmacological therapies proven effective for treatment of long COVID. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 The expression of proteins associated with inflammation (LGALS9, CCL21, CCL22, TNF, CXCL10 and CD48) and immune regulation (IL1RN and CD22) have been shown to be elevated in individuals with long COVID versus full-recovered individuals.4 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Thus, drugs modulating inflammation, and that work to regulate the BBB integrity, could represent potential therapeutic mechanisms for treating neurological symptoms of long COVID. About BezisterimBezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation. Bezisterim is also being investigated for Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders 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 bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. 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 bezisterim 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 AD and PD. 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 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 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. References1 Ford ND, Agedew A, Dalton AF, Singleton J, Perrine CG, Saydah S. Notes from the Field: Long COVID Prevalence Among Adults — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:135–136. DOI: http://dx.doi.org.libproxy1.nus.edu.sg/10.15585/mmwr.mm7306a4. 2 Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu) 3 Evans RA, Leavy OC, Richardson M, et al. Clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK: a prospective observational study. The Lancet Respiratory Medicine. 2022;10(8):761-775. 4 Yin K, Peluso MJ, Luo X, et al. Long COVID manifests with T cell dysregulation, inflammation and an uncoordinated adaptive immune response to SARS-CoV-2. Nature Immunology. 2024;25:218-225. 5 Greene C, Connoly R, Brennan D, et al. Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID-associated cognitive impairment. Nature Neuroscience. 2024;27:421-432. 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

Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated with long COVID Key milestone reached ahead of schedule, with BioVie on track to receive additional $12.6 million of award from the U.S. Department of Defense and initiate the Phase 2 trial Recent Centers for Disease Control and Prevention survey estimated over 5% of U.S. adults currently have long COVID, and ~3.6 million people reported significantly modifying their activities because of illness1 Sept. 03, 2024 -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (“IND”) application to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. Receipt of this FDA authorization puts the Company ahead of schedule and on track to receive an additional $12.6 million in grant funding from the U.S. Department of Defense (“DOD”) and initiate its Phase 2 trial. “We are delighted to announce that the FDA has authorized our IND application for bezisterim, allowing us to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID,” said Cuong Do, BioVie’s President and CEO. “A growing body of evidence points to inflammation as a key driver of long COVID, and we believe that bezisterim has shown promise in addressing these underlying mechanisms. This is a significant milestone that brings us closer to exploring how bezisterim could help patients with this debilitating condition.” The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety and tolerability of 3 months of treatment with bezisterim and the potential ability to reduce the neurocognitive symptoms associated with long COVID. Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that around 5.5% of adults in the U.S. currently have long COVID, and around 3.6 million people have reported significantly modifying their activities because of the illness.1 Symptoms include cognitive dysfunction and fatigue and are debilitating. No therapies have proven effective for treatment to date. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting a suspected underlying cause of long COVID symptoms. The work is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with the option, if approved, to receive an additional $12.6 million, to initiate a clinical trial once the planning phase has concluded and milestones have been met, through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, hearing loss, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that 5.5% of adults in the United States (more than 17 million individuals) currently have long COVID, and 18.3% have experienced it at some point.1 With around 3.6 million people having reported significantly modifying their activities because of long COVID, the loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be $3.7 trillion.1,2 To date there are no non-pharmacological or pharmacological therapies proven effective for treatment of long COVID. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 The expression of proteins associated with inflammation (LGALS9, CCL21, CCL22, TNF, CXCL10 and CD48) and immune regulation (IL1RN and CD22) have been shown to be elevated in individuals with long COVID versus full-recovered individuals.4 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Thus, drugs modulating inflammation, and that work to regulate the BBB integrity, could represent potential therapeutic mechanisms for treating neurological symptoms of long COVID. Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation. Bezisterim is also being investigated for Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders 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 bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. 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 bezisterim 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 AD and PD. 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 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 www.bioviepharma.com. References 1 U.S. Census Bureau. Household Pulse Survey, 2022-2024. https://www-cdc-gov.libproxy1.nus.edu.sg/nchs/covid19/pulse/long-covid.htm. 2 Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu) 3 Evans RA, Leavy OC, Richardson M, et al. Clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK: a prospective observational study. The Lancet Respiratory Medicine. 2022;10(8):761-775. 4 Yin K, Peluso MJ, Luo X, et al. Long COVID manifests with T cell dysregulation, inflammation and an uncoordinated adaptive immune response to SARS-CoV-2. Nature Immunology. 2024;25:218-225. 5 Greene C, Connoly R, Brennan D, et al. Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID-associated cognitive impairment. Nature Neuroscience. 2024;27:421-432. The content above comes from the network. if any infringement, please contact us to modify.

Bezisterim appears to possess broad homeostatic properties relevant to inflammation and human disorders related to aging Patients treated with bezisterim experienced 2 to 4 years age deceleration advantage compared to placebo Bezisterim modulated DNA methylation of proinflammatory genes and appeared to promote the transition of M1 proinflammatory to M2 anti-inflammatory macrophages Bezisterim was associated with 1.5 to 2.3 “fold enrichment” on gene control for hundreds of genes in pathways associated with neurodegenerative disorders and biological processes CARSON CITY, Nev., Aug. 27, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced data from an oral presentation at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) being held August 26-30, 2024 in Copenhagen, Denmark. The presentation “Bezisterim Effects on Biological Age, Alzheimer’s Epigenetics, and Neurologic Assessments” provided an overview of clinical data to-date on bezisterim, focusing on various analyses and measurements related to longevity and its ability to affect the biological aging process broadly and chronic low-grade inflammation specifically. The presentation was given by Christopher L. Reading, BioVie’s Senior Vice President, Alzheimer’s Disease Program. “The presented clinical data provides the deepest understanding yet of how bezisterim may work at the gene level to reduce inflammation and impact disease,” said Cuong Do, BioVie’s President and CEO. “The data shows that patients treated with bezisterim experienced a two- to four-year age deceleration advantage when compared to placebo as measured by various biological clocks. The DNA methylation data also explain how bezisterim could modulate the function of specific proinflammatory genes and support the transition of M1 proinflammatory macrophages to the M2 anti-inflammatory state. Most importantly, the data shows bezisterim’s potential ability to control the expression of specific genes in pathways associated with diseases ranging from Parkinson’s and Alzheimer’s to ALS and biological processes ranging from TNF signaling to apoptosis.” As people age, a natural process called DNA methylation occurs where methyl groups are added to the surface of DNA. The over- or undermethylation of various genes have been shown to be associated with many diseases and the aging process itself. The presentation at ARDD 2024 detailed how bezisterim modulates DNA methylation and may have an impact in the following areas: The extent of DNA methylation of a person’s genome can be measured by a series of “clocks” that measure a person’s biological age, and the difference between the biological age and the number of years since birth is known as age deceleration or acceleration. In a clinical trial, patients treated with bezisterim saw an age deceleration advantage compared to those on placebo on various clocks: 3.68 years advantage on SkinBlood Clock (p=0.017), 4.77 years advantage on the Inflammation Age Clock (p=0.022), 5.0 years advantage on the Hannum Age Clock (p=0.006), 1.92 years advantage on the GrimAge Clock (p=0.068), and 3.71 years on the PhenoAge Clock (p=0.081). Bezisterim is believed to be the first drug candidate to show in a clinical trial an impact on modulating DNA methylation and age deceleration in a manner that is associated with specific diseases.DNA in blood comes predominantly from 3 cell types: monocytes/macrophages, lymphocytes, and granulocytes, and another set of clocks predicts the level of these immune cells. In the trial, the lymphocyte and granulocyte clocks are strongly and significantly correlated to observed levels of these cells for all patients. Placebo-treated patients saw a similar correlation between the monocyte clock and observed monocyte cell levels while bezisterim-treated patients did not show such correlation. Monocytes/macrophages control innate immunity and inflammation. The observed data suggest that bezisterim may support the transition of macrophages (and microglia in the CNS) from pro-inflammatory M1 state toward the M2 anti-inflammatory M2 state.Inflammatory factors, including TNFα, IL6, and MCP1, are produced when molecules such as ERK, MAP3K8, and NFκB perform their roles in various interrelated pathways, and the disruption of their function would disrupt the production of the inflammatory factors. The clinical data presented shows that bezisterim has the potential to significantly modulate the methylation levels of the genes that code for ERK, MAP3K8, NFκB, TNFα, IL6, and others. The data suggest that modulating the methylation levels for the individual actors in the various pathways could lead to reduced production of the inflammatory factors themselves.The Kyoto Encyclopedia of Genes and Genomes (KEGG) provides a mapping of known genes, molecules and pathways associated with individual diseases and cellular functions. The clinical data shows that bezisterim is associated with 1.5 to 2.3 “fold enrichment” (genes modulated compared to the pathway genes) in the pathways examined (all p<0.05). This impact was found for pathways leading to Alzheimer’s Disease, Parkinson’s Disease, amyotrophic lateral sclerosis, Huntington’s disease, and the biological processes involving cellular senescence, apoptosis, and TNF signaling. About DNA Methylation and Bezisterim’s Potential Modulating Role Everything in the body is encoded for by DNA, which is comprised of a series of four bases: adenine (A), cytosine (C), guanine (G), and thymine (T). As people age, a natural process known as DNA methylation can occur whereby a methyl group is added at various places where a cytosine is adjacent to a guanine (known as a CpG group). Current technology can measure the extent of methylation at roughly 965,000 such CpG sites in our genome, and many of the specific CpG sites can be mapped to genes with known functions. When DNA methylation occurs, the function of that specific gene is impaired because the molecule responsible for decoding that gene may not be able to properly access the genetic information. Epigenetics is the study of how behavior (e.g., diet, exercise) and environment affect the way our genes work in addition to the genetic code itself, and there’s an increasing body of evidence that signs of aging are epigenetic in nature.1,2 Perhaps the most studied area of epigenetics involves DNA methylation.3 Many studies have shown that genes become over- or under-methylated as we age,4,5,6 thereby suggesting that the modulation of DNA methylation could enable the up- or down-regulation of specific genes and thus modulate the aging process. Several “biological clocks” have been created to determine the biological age of our body based upon DNA methylation levels. A person’s biological age may be different from their actual number of years since birth due to their living habits that may lead to increased or lowered levels of DNA methylation, and the difference between biological age and chronological age is known as age deceleration or acceleration. Inflammation is a natural phenomenon associated with the body protecting itself. When a stimulus arises that recruits immune cells to help, these cells may release various inflammatory factors (e.g., TNFα, cytokines, chemokines, etc.) as part of their natural function. When the original stimulus has been addressed, immune cells reduce their activity and inflammation correspondingly decreases. When living choices and conditions create a situation where the stimulus is constant, chronic low-grade inflammation can arise since immune cells are constantly at work and are constantly releasing the inflammatory factors. Chronic low-grade inflammation is believed to be the underlying biological driver of many diseases. Inflammation results from a series of intricate and interrelated pathways involving actors such as ERK, MAP3K8, NFκB, and others that work together to trigger the production of inflammatory agents such as TNFα, IL6, IL17, etc. The genes that code for these pro-inflammatory actors can also be methylated. When these proinflammatory genes are methylated in control regions, their function becomes muted and results in the downward expression of the resulting inflammatory factors. The clinical data suggest that bezisterim appears to be broadly homeostatic for inflammatory processes and thus has specific up- and down-regulatory roles depending on which CpG and gene it affects (i.e., it does not indiscriminately reduce or increase methylation across the board). The data shows bezisterim modulates methylation for many CpGs as witnessed by the reduction of the biological age across the various clocks. With inflammatory genes, bezisterim upregulates the methylation of genes in the proinflammatory pathways, leading to reduced expression of these genes, which can reduce TNFα and other inflammatory factors. About Bezisterim Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNγ). NE3107 has been shown to modulate the activation of NFκB and thus modulate inflammation. Bezisterim is being investigated for Alzheimer’s disease (AD) and Parkinson’s disease (PD). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders 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 bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. 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 bezisterim 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 AD and PD. 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 www.bioviepharma.com. 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" 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: Contact: Bruce Mackle Managing Director LifeSci Advisors, LLC bmackle@lifesciadvisors.com For Media InquiresMelyssa WeibleManaging Partner, Elixir Health Public Relations Ph: +1 201-723-5705mweible@elixirhealthpr.com ______________________ 1 Oberdoerffer P Nat Rev Mol Cell Biol 2007, 8:692–702.2 Campisi J J Gerontol A Biol Sci Med Sci 2009, 64A:175–178.3 Moore L Neuropsychopharmacology vol 38, pages23–38 (2013)4 Fraga MF Ann N Y Acad Sci 2007, 1100:60–74.5 Christensen BC PLoS Genet 2009, 5:e10006026 Horvath S Genome Biol 2012, 13:R97