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    BIVI   US09074F2074

BIOVIE INC.

(BIVI)
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Delayed Nasdaq  -  03:59 2022-08-05 pm EDT
2.180 USD   -0.91%
07/28B. Riley Lowers BioVie's Price Target to $12 from $18 Reflecting More Sharpened Focus of Target Model, Keeps Buy Rating
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07/25BioVie Inc. announced that it has received $6.000001 million in funding from Acuitas Group Holdings Llc
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BioVie : Regulation FD Presentation - Form 8-K

06/29/2022 | 08:38am EDT

Developing Transformative Therapies to Overcome Chronic Debilitating Diseases Corporate Presentation • June 2022

©2022 BioVie Inc. I Corporate presentation Forward - looking statements This document contains forward - looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie's actual results and experience to differ materially from anticipated results and expectations expressed in these forward - looking statements . BioVie has in some cases identified forward - looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions . Among other factors that could cause actual results to differ materially from those expressed in forward - looking statements are : BioVie's need for, and the availability of, substantial capital in the future to fund its operations and research and development . Other risks are that BioVie's compounds may not successfully complete pre - clinical or clinical testing or be granted regulatory approval to be sold and marketed in the United States or elsewhere . BioVie cannot guarantee the effectiveness of its patents or Orphan Drug designations . A more complete description of these risk factors is included in BioVie's filings with the Securities and Exchange Commission . In addition to the risks described above and in BioVie's filings with the Securities and Exchange Commission, other unknown or unpredictable factors also could affect BioVie's results . No forward - looking statements can be guaranteed and actual results may differ materially from such statements . You should not place undue reliance on any forward - looking statements . BioVie undertakes no obligation to release publicly the results of any revisions to any such forward - looking statements that may be made to reflect events or circumstances after the date that these slides are posted to BioVie's website or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation . 2

©2022 BioVie Inc. I Corporate presentation Highlights NE3107 is the only inhibitor , to our knowledge, that is being studied for of inflammation and insulin resistance in Phase 3 trials for Alzheimer's Disease (AD) • NE3107 is believed to potentially reduce neuroinflammation and insulin resistance in randomized, double - blinded, placebo - controlled Phase 2 study; potential to address the two factors described as potential key drivers of cognitive decline in AD • Phase 3 patient enrollment underway; ramping to 45 centers; data readout anticipated mid - 2023 • $10+ billion annual peak sales potential • NE3107 equally pro - motoric as levodopa, reduced severity of levodopa induced dyskinesia (LID), and preserved twice as many neurons as untreated in preclinical studies • Phase 2 trial start 1Q22; data readout anticipated mid - 2022 • $3+ billion annual peak sales potential • Formulation of terlipressin for continuous infusion; Method of use patent for treatment of ascites; potential to become first therapy since there are no approved drugs in the US; Orphan and Fast Track designations received • Decades of data gathered from European/Asia; No drug - related SAEs in trials thus far • Phase 2b underway with data readout anticipated early - 2023 • $1+ billion global peak sales potential BIV201 is the only drug to our knowledge, currently in development for refractory ascites, a condition with 50% mortality rate 3 NE3107 is also being studied developed for Parkinson's disease (PD) based on similar mechanism of action

©2022 BioVie Inc. I Corporate presentation Catalysts & Anticipated Timelines (US) 4 2021 2022 2023 2024 2025 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Alzheimer's (NE3107) Parkinson's (NE3107) Ascites (BIV201) Phase 3 (US) Phase 3 for global registration Phase 2a Phase 3 Phase 2b Phase 3 Launch File NDA * Two Phase 3 trials are usually required for registration. However, the FDA has allowed filing based on strong data from a sin gle pivotal trial in indications with few therapeutic options. ?* ?* Investigator - Initiated Ph 2

©2022 BioVie Inc. I Corporate presentation Portfolio Revenue Potential 5 1 Anticipated to be extendable to 2034 2 Based on internal company estimates and compilation of analyst data Company Estimates 2 U.S. Intellectual Property US Patient Population US Peak Sales Potential Global Sales Potential NE3107: Alzheimer's Compound patent through 2031 1 6.1 million $7 billion >$10 billion NE3107: Parkinson's Compound patent through 2031 1 1.0 million $1.5 billion >$3 billion BIV201: Refractory Ascites Orphan Drug; Patent - pending formulation; Patent issued method of use 20,000 $450 million >$900 million

©2022 BioVie Inc. I Corporate presentation At the Alzheimer's Association International Conference 2021: Hundreds of presentations on neuroinflammation as a driver of AD; Dozens of presentations on inflammation - driven brain insulin resistance Neuroinflammation and insulin resistance are described as primary factors leading to cognitive decline and neuronal loss in AD: Neuroinflammation ~3,400 publications. Insulin resistance ~900 publications There are 7 current biotech/pharma anti - neuroinflammation trials AD has been termed "Type 3 Diabetes" and "cognitive - metabolic syndrome"* 6 Roles of Inflammation and Insulin Resistance Well Established in AD Progression * de la Monte, S.M. and J.R. Wands, Alzheimer's disease is type 3 diabetes - evidence reviewed. J Diabetes Sci Technol, 2008. 2(6): p. 1101 - 13

©2022 BioVie Inc. I Corporate presentation Extracellular Signal - Regulated Kinase (ERK) 7 Critical player for both homeostasis and inflammation (and resulting inflammation - induced insulin resistance) Insulin Ras Cell/Synapse growth, repair, and regeneration MEK TNF a ERK NFKB Extracellular signals (e.g., cytokines, chemokines, A b , tangles, etc.) Inflammatory factors (e.g., p38, JNK, cytokines, etc.)

©2022 BioVie Inc. I Corporate presentation NE3107 Blocks Inflammatory, but not Homeostatic ERK Signaling 8 • Small molecule; orally bioavailable • Crosses blood - brain barrier • No safety issues identified to date in pre - clinical and clinical trials (up to Phase 2) First - in - class molecule with desirable characteristics Insulin Ras Cell/Synapse growth, repair, and regeneration MEK TNF a ERK NFKB Extracellular signals (e.g., cytokines, chemokines, A b , tangles, etc.) Inflammatory factors (e.g., p38, JNK, cytokines, etc.)

©2022 BioVie Inc. I Corporate presentation Prior NE3107 Clinical Studies 9 Obese, impaired glucose tolerant healthy volunteers Phase 1 1 NE3107: • Improved insulin - stimulated glucose disposal, assessed by hyperinsulinemic , euglycemic glucose clamp procedures • Decreased C - reactive protein (CRP 2 ) and increased HDL and adiponectin (both associated with benefit in AD) • Showed no differences in AEs compared to placebo NE3107: • Decreased insulin resistance, postprandial glucose and HbA1c compared to placebo • Decreased inflammation - driven systems dysregulation of inflammatory, hematopoietic and metabolic parameters compared to placebo 4 • Showed no differences in AEs compared to placebo Phase 2 3 Obese and inflamed type 2 diabetes subjects 1. Reading Mediators Inflamm 2013 814989 2. CRP is a nonspecific marker of inflammation that is increased in the brain and serum of patients with Alzheimer's disease (AD ), and has been associated with increased risk of developing dementia 3. Reading 2013 Obesity 21 E343 4. Systems dysregulation in diabetes has been shown to increase risk for AD, and similar systems dysregulation of laboratory and cl inical parameters is correlated with AD progression.

©2022 BioVie Inc. I Corporate presentation • >4,000 scientific publications support the role of inflammation and insulin resistance in AD 1 • >80% of AD patients also have (or developing) Type 2 Diabetes 2 • Data from preclinical and clinical studies show that NE3107: ⎻ Reduces inflammation and enhances insulin sensitivity, which may potentially reduce AD pathology ⎻ Blocks EPIC, upstream from amyloid beta and phospho - tau, further reducing inflammation ⎻ Demonstrates potential neuroprotective properties in models of PD, optic neuritis and glaucoma ⎻ NE3107 has been well - tolerated in clinical studies to date ⎻ Reduces systems deregulation (enhances homeostasis) ⎻ Crosses blood brain barrier (BBB) • Phase 3 to review whether NE3107's impact on inflammation and insulin resistance can help reduce the rate of cognitive decline ⎻ Decrease inflammation è i ncrease insulin sensitivity è decrease in rate of cognitive decline ⎻ Potential for enhancement of cognition due to insulin's role in the brain Ongoing Pivotal Phase 3 for Alzheimer's Disease 10 1. Pubmed search for " Alzherimer's disease" and "inflammation" or "insulin resistance" 2. Janson 2004 Diabetes 53 474

©2022 BioVie Inc. I Corporate presentation A Phase 3, Double - blind, Randomized, Placebo - controlled, Parallel Group, Multicenter Study of NE3107 in Patients who have Mild t o Moderate AD • Pivotal study for Alzheimer's disease. Two weeks each of 5 mg and 10 mg BID dose titration followed by 26 weeks of 20 mg twic e d aily vs. placebo, approximately 160 subjects in each arm, 80% power • Diagnosed with AD and without evidence of a vascular contribution. Mild to moderate disease. CDR 1 - 2. MMSE 14 - 24. • 60 - 85 years old, males and females • Randomization stratified by MMSE and Homeostatic Model Assessment 2 Insulin Resistance (HOMA2) • Co - primary endpoints ⎻ Mean change from Baseline to Week 30 in the twelve - question form of the Alzheimer's Disease Assessment Scale - Cognitive (ADAS - Cog 12) comparing the NE3107 group to the placebo group ⎻ Mean change from Baseline to Week 30 in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) c omparing the NE3107 group to the placebo group • Secondary endpoints ⎻ ADCS - ADL (functional), ADCOMS (4 Alzheimer's Disease Assessment Scale - cognitive subscale items, 2 Mini - Mental State Examination items, and all 6 Clinical Dementia Rating - Sum of Boxes items), NPI - 12 (care - giver rating of behavioral changes), MMSE, CDR ⎻ Glycemic control: HOMA2, Mean Amplitude of Glycemic Excursion (MAGE) using continuous glucose monitoring, fructosamine levels, post - prandial glucose and fasting blood glucose vs time. ⎻ MRI total hippocampus volume change, baseline to end of treatment in a subset of approximately 50% of active and placebo subj ect s ⎻ Target engagement assessed in a small subset of active and placebo subjects using PET to quantify cortical glucose utilizatio n NM101: Phase 3 trial in Mild to Moderate Alzheimer's Disease, NCT04669028 11

©2022 BioVie Inc. I Corporate presentation An open - label, Investigator - Initiated exploratory biomarker study in patients who have MCI to Mild AD • 55 - 89 years old, males and females experiencing cognitive decline with Clinical Dementia Rating (CDR) score of 0.5 to 1, suggest ing mild cognitive impairment to mild dementia • Study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Alzheimer' s d isease and inflammatory and metabolic parameters that can be measured in the CNS with advanced neuroimaging techniques in patients before and after treat men t with 20 mg of NE3107 twice daily for 3 months • Use advanced functional magnetic resonance imaging (fMRI) to assess change from baseline to completion ⎻ Change in glutathione levels will be analyzed as measured by Magnetic Resonance Spectroscopy (MRS) ⎻ Change in Diffusion Tensor Imaging - Neurite Orientation Dispersion Density Imaging (DTI - NODDI) to assess stabilization and or i mprovement in dendritic density ⎻ Change in Arterial Spin Labeling (ASL); change in functional connectivity of the nucleus basalis of meynert (NBM) with both hippocampi as well as between both hippocampi; and change in Neurovascular Coupling (NVR) as measured on BOLD imaging • Additional exploratory endpoints ⎻ Clinical Dementia Rating Change as calculated from the Quick Dementia Rating Scale (QDRS) Change ⎻ Montreal Cognitive Assessment (MoCA) Change ⎻ Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS - Cog11) Change ⎻ Mini - Mental State Examination (MMSE) Change ⎻ Glucose Serology/Metabolic Level Change Investigator - Initiated Trial in MCI and Mild Alzheimer's Disease, NCT05227820 12

©2022 BioVie Inc. I Corporate presentation Remarkable parallels exist between AD and PD 13 Neuroinflammation and oxidative stress are common features in the major neurodegenerative diseases, Alzheimer's, Parkinson's, frontotemporal lobar dementia and ALS Activated microglia - inflammation Systemic inflammation driven TNF driven Insulin resistance, metabolic dysfunction Mitochondrial dysfunction and oxidative stress Endoplasmic reticulum stress - unfolded protein response Misfolded protein aggregates (alpha synuclein, Lewy bodies for PD) Controversial etiology, slow progression Remarkable Similarities Between Neurodegenerative Diseases

©2022 BioVie Inc. I Corporate presentation Our Phase 2 is a combined DDI and efficacy program to test a clear and plausible hypothesis Decreased inflammation > increased insulin sensitivity > disease amelioration • Promotoric activity • Reduction in LID FDA requires a drug - drug interaction study before proceeding to later phase trials in patients that might use or need levodopa • No indications of DDI in animal studies have been observed NE3107 reduced inflammation and enhanced insulin sensitivity in animal models 1 , both of which have been shown to reduce PD pathology • Reduction of inflammation itself may be beneficial since both inflammation and low dopamine environment are required for Parkinsonism • NE3107 was promotoric , reduced LID and preserved dopaminergic neurons in marmosets 14 Proceeding to Clinical Development for Parkinson's Disease 1. Beck Mov Disord . 2018 May ; 33(5): 805 - 814; Lee Int. J. Mol. Sci. 2021, 22, 2098; Pang Neuroscience. 2016 March 24; 318: 157 - 165; Pereira Front. Pharmacol . 11:617085; Yan Front. Aging Neurosci . 12:625166.; Novak PLoS ONE 14(4): e0214364. https://doi.org/10.1371/journal.pone.0214364;

©2022 BioVie Inc. I Corporate presentation * Motor Disease Society Unified Parkinson's Disease Rating Parkinson's Disease Clinical Development Program 15 NM201 Phase 2 40 patients with defined L - dopa "off state", 1:1 active: placebo, 20 mg BID for 28 days NM202 Phase 3 • Assess NE3107 pro - motoric activity while satisfying FDA requirement for drug - drug interaction study with L - dopa • Safety assessments : Standard measures of patient health, L - dopa PK and DDI • Efficacy assessments: MDS - UPDRS* parts 1 - 3, Hauser ON/OFF Diary, Non - Motor Symptom Scale • Possibly pivotal design • Evaluate NE3107 promotoric activity in 200 patients needing to start L - dopa or (depending on Phase 2 results) 200 patients on L - dopa therapy for more than 3 years • Primary endpoint MDS - UPDRS parts 1 - 4

©2022 BioVie Inc. I Corporate presentation 1. TIPS = transjugular intrahepatic portosystemic shunt to channel blood flow around the liver 2. Derived from Scaglione J Clin Gastroenterol. 49(8):690 - 6; D'Amico Journal of Hepatology, Volume 44, pp. 217 - 231; D'Amico Aliment Pharmacol Ther . 39(10):1180 - 93; Samonakis World Journal of Hepatology, 6(7), pp. 504 - 512; Sivanathan Dtsch Med Wochenschr , Volume 139, pp. 1758 - 1762 and Gines New England Journal of Medicine, 350(16), pp. 1646 - 1654. BIV201 Disease Target: Refractory Ascites 16 Refractory ascites patients typically undergo paracentesis to remove ascites fluid every week to 10 days Paracentesis: Withdrawal of 5 - 10L of ascites fluid (on average) from abdomen using a large bore needle Provides a few days of symptomatic relief The kidneys are "burning out" by retaining massive quantities of salt and water Patients suffer frequent life - threatening complications No remaining options except for TIPS 1 surgery or liver transplant Estimated $670 million addressable US market with 20,000 2 targeted patients No drugs ever approved by FDA to treat ascites Our first disease target is ascites, the accumulation of 5+ liters of fluid in the abdomen.

©2022 BioVie Inc. I Corporate presentation Prefilled Syringe with Patent - pending Liquid Formulation *In clinical trials; not approved by FDA BIV201* Our liquid formulation of terlipressin. We will seek patent protection in the US, Europe, China and Japan Accurate dosing Eliminates mixing minute quantities of powder terlipressin that could result in medication errors or sterility loss Enhanced convenience Simply inject fluid into the saline bag and attach to pump BIV201 Prefilled Syringe Stable for 18+months at room temp. Needle or Connector 50 mL bag of saline for insertion into pump Portable pump Carried in small satchel 17

©2022 BioVie Inc. I Corporate presentation • Hepatorenal syndrome - acute kidney injury 1 News Detail | Mallinckrodt Pharmaceuticals June 13, 2022 Ascites • 9 trial sites are activated and screening/enrolling patients • 20 ascites patients to receive BIV201 therapy + standard of care (SOC); 10 to receive SOC only (control group) ⎻ Co - primary endpoints: Incidence of ascites - related complications over 180 days following randomization and change in ascites flu id removed over 90 days • Timeframe: Two 28 - day cycles of BIV201 therapy within 4 months, then follow patients for additional 60 days • Similar trial design planned for a single pivotal Phase 3 planned in 2023 with ~120 subjects BIV201 Development Plans HRS - AKI • Planning a possible registrational Phase 3 trial in HRS - AKI* ⎻ For better outcomes because earlier treatment is possible than for HRS Type 1 ⎻ For improved safety with continuous infusion dosing compared to Mallinckrodt's CONFIRM study of terlipressin in HRS type 1 • Mallinckrodt used bolus injections (1 or 2 mg given over approx. 5 min) ⎻ They achieved the efficacy objective but received two CRLs to date. NDA recently resubmitted 1 • Agreement reached with FDA on key elements of Phase 3 trial design ⎻ We plan to use same PI's, same sites, and same drug product as our current ascites study ⎻ Orphan drug designation for HRS (in addition to ascites) 18

©2022 BioVie Inc. I Corporate presentation Leadership Team 19 Deep expertise provides a strong foundation for success Joseph Palumbo, MD, Chief Medical Officer 30+ years treating patients; 25+ years in biopharma CMO, Zynerba Global Head of Medical Science & Translational Research, Global Head & Psychiatry Franchise Medical Leader, J&J Penelope Markham, Liver Cirrhosis Program 25 years in biopharma drug development Lead Scientist Terlipressin ( LATPharma / BioVie 11 years) Head Research Biology Protez Pharma Co - founder/Director of Research Influx Inc. Jonathan Adams , Liver Cirrhosis Program 30+ years in biopharma​ Founded LAT Pharma (BioVie predecessor)​ Mission Pharmacal​ Corbett and other healthcare agencies​ Searle Pharmaceuticals Chris Reading, PhD, Neurodegenerative Disease Program 40+ years in biopharma Chief Scientific Officer, Hollis - Eden Pharmaceuticals VP of Product and Process Dev. for Systemix U Texas Dept. of Tumor Biology Clarence Ahlem , Neurodegenerative Disease Program 35+ years in biopharma Vice President, Product Development Harbor Therapeutics Director, Product Development, Hollis - Eden Pharmaceuticals US San Diego J. Wendy Kim, Chief Financial Officer 35 years in finance/ accounting As CFO managed corporate finance and operations groups Closed M&A transactions and secured financings Combined 22 years at KPMG and BDO LLP Cuong Do, President & Chief Executive Officer 30+ years in biopharma & technology President, Samsung Global Strategy Group Chief Strategy Officer for Merck Senior partner at McKinsey & Company

Thank You 20

©2022 BioVie Inc. I Corporate presentation Reading 2013 Obesity 21 E343. Note: NE3107 was originally known as HE3286 from Hollis Eden Pharmaceuticals Improved insulin - dependent glucose disposal in 48 obese, inflamed subjects 21 Day 29 Glucose disposal rate (M, measured in mg/kg/min in glucose clamp studies) value change as a function of baseline M r 2 = 0.54, P < 0.0001) r 2 = 0.004, P < 0.9) NE3107's ability to enhance insulin sensitivity reproduced in humans in Phase 1 trial with impaired glucose tolerance patients

©2022 BioVie Inc. I Corporate presentation In a Phase 1 study 48 obese subjects with impaired glucose tolerance, NE3107 … 22 52 75 27 0 All >4.2 <4.2 0 0 Proportion of patients with improvements (%) 36 20 50 73 91 50 All <4.2 >4.2 9 17 52 58 45 0 All <4.2 >4.2 ** ** * * * * Baseline M*** All -2 -1 0 1 2 3 Adiponectin (Day 28 Change) Baseline M m g / m L Placebo HE3286 ✱ Increased insulin sensitivity … … increased HDL … … decreased CRP … … and increased adiponectin Placebo HE3286 Insulin sensitizing improvement also brought improvements in AD indicators Fischer's exact test p<0.05 **p<0.01 *** Baseline glucose disposal rate (M) measured in mg/kg/min. Median baseline is 4.2 Source: Reading 2013 Obesity 21 E343. Note: NE3107 was originally known as HE3286 from Hollis Eden Pharmaceuticals

©2022 BioVie Inc. I Corporate presentation 23 Reading 2013 Mediators Inflamm 814989. Note: NE3107 was originally known as HE3286 from Hollis Eden Pharmaceuticals Cohort 1 baseline MCP - 1 > 40 pmol /L individual subject changes in homeostatic model assessment of insulin resistance at Day 84 … decreased HbA1c … Pooled cohorts 1 and 2 changes at Day 84 Day 112 cohort 2 baseline BMI > 31 kg/m 2 … decreased insulin resistance in inflamed T2D patients Improved the homeostatic model assessment of insulin resistance … … decreased postprandial glucose … NE3107's ability to enhance insulin sensitivity reproduced in humans in Phase 2 trial with T2D patients

©2022 BioVie Inc. I Corporate presentation • Patients with increasing metabolic disease show greater variability for individual hematology, metabolic and chemistry values • Indicates increasing dysregulation Inflammation drives systems dysregulation 24 DL: dyslipidemic placebo group, IGT: impaired glucose tolerant placebo group, Naïve: treatment - naïve uncontrolled T2DM placebo group, MET: uncontrolled T2DM placebo group on a stable dose of metformin Hb: hemoglobin, Hct : hematocrit, RBC: red blood cell count, MCV: mean cell volume, MCH: mean corpuscular hemoglobin, MCHC: mean corpuscular hemoglobin concentration, HbA1c: hemoglobin A1c, HDL: high density lipoprotein cholesterol, LDL: low density lipoprotein cholesterol. #Statistically Significant Welch ANOVA). ∗ Statistically significant 2 - sided ܨ ܨ test. Reading 2013 Mediators Inflamm 814989

©2022 BioVie Inc. I Corporate presentation Heteroscedasticity* investigated by analyzing data distributions for normality (Shapiro - Wilks ܹ test) • Deviations from normal distribution represents dysregulation Placebo patients had significantly abnormal data distributions after 84 days of treatment whereas NE3107 subjects did not • Placebo patients had many parameters that significantly deviated from normal distribution (i.e., dysregulated) • NE3107 treatment reduced systems dysregulation Group Cohort 1 MCP - 1 > 40 Cohort 2 BMI > 31 HE3286 n=44 n=22 n=35 n=12 Placebo n=51 n=25 n= 34 n= 15 25 * Heteroscedasticity describes differences in variances between groups. Reading 2013 Mediators Inflamm 814989. Note: NE3107 was originally known as HE3286 from Hollis Eden Pharmaceuticals NE3107 decreased systems dysregulation in a Phase 2 study in advanced T2D patients

©2022 BioVie Inc. I Corporate presentation Cunningham 2015 Alzheimers Res Ther 7 33 26 SIEs: serious inflammatory events Systemic inflammation and co - morbidity as drivers of cognitive decline

©2022 BioVie Inc. I Corporate presentation 1 As reported in Clinicaltrials.gov on 06/07/22 2 Closing value on 06/07/22 • Extensive study data supports reducing neuroinflammation as the key to slowing/reversing cognitive decline • Other companies focused on this target: Targeting Neuroinflammation in Alzheimer's Disease 27 NE3107 anticipated to have significant advantages over competition • Phase 3 clinical studies initiated with data readout targeted for mid 2023 • Potentially inhibits both overarching mechanisms of AD pathology: inflammation and insulin resistance • Potentially inhibits proinflammatory pathways without impacting homeostasis Company Exchange:Ticker Drug Candidate Clinical Status 1 Mechanism of Action Market Cap ($mm) 2 BioVie Inc. Nasdaq: BIVI NE3107 Phase 3 Inhibits ERK/ NFkB neuroinflammation Inhibits insulin resistance $46 Cortexyme , Inc. Nasdaq: CRTX Atuzaginstat Phase 2/3 Inhibits P. gingavalis toxin $119 Cassava Sciences Nasdaq: SAVA Simufilam Phase 3 Restores filamin A $1,158 Athira Pharma Nasdaq: ATHA ATH - 1017 Phase 3 Activates neuron regenration $347 Vaccinex Nasdaq: VCNX VX15 Phase 1/2 Ab to SEMA4D neuroinflammation $55 Annovis NYSE: ANVS ANVS - 401 Phase 3 Decreases APP & Tau $88 InmuneBio Nasdaq: INMB XPRO1595 Phase 1b dN TNF neuroinflammation $125 Denali Therapeutics Nasdaq: DNLI DNL788 preclinical RIPK1 inhibitor, TNFR pathway $3,087

©2022 BioVie Inc. I Corporate presentation MPTP: 1 - methyl - 4 - phenyl - 1,2,3,6 - tetrahydropyridine, a toxin used to mimic many aspects of PD 28 MPTP Marmoset treated at Week 8 L - dopa and NE3107 combination is better than either drug alone * * * *p<0.001 compared to other treatment arm in time period ** L - Dopa at week 11 not statistically different from NE3107 at weeks 8 and 9 ** Week 8 Week 9 Week 10 Week 11 0 1 2 3 4 M e a n D i s e a s e S c o r e Placebo NE3107 L-Dopa NE3107+L-Dopa NE3107's promotoric effects observed within 4 days of treatment NE3107 has similar promotoric activity to L - dopa in rodent and marmoset models MPTP Mouse

©2022 BioVie Inc. I Corporate presentation 29 0 5 10 15 20 25 30 Score Frequency Abnormal Involuntary Movement Scale (AIMS) NE3107 Placebo Amantadine Distribution of AIMS Scores Less More Dyskinesia NE3107 decreases L - Dopa - induced dyskinesia (LID) in marmosets 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

©2022 BioVie Inc. I Corporate presentation Note: NE3107 was originally known as HE3286 from Hollis Eden Pharmaceuticals NE3107 preserved TH+ neurons in MPTP marmosets 30 Control moneys (M09100 and M11008) HE3286 (M11007) Amantadine (M10084)

©2022 BioVie Inc. I Corporate presentation Source: BioVie poster presentation at AASLD 2019. BIV201 is an investigational therapy BioVie Phase 2a trial results: BIV201 Pharmacokinetics 31 Comparison of the PK Profile of Terlipressin Administered by Continuous Infusion or Intermittent IV Boluses. Simulated terlipressin plasma concentrations following IV bolus of 1 mg every 6 hours 1 [Lucassin, AusPAR-cer 2011] and IV continuous infusions of 2 mg, 3 mg, or 4 mg per day Continuous low blood levels of terlipressin versus spikes with IV - bolus dosing

©2022 BioVie Inc. I Corporate presentation Retrospective study results from P. Angeli, MD (Italy 2015) Continuous Infusion Terlipressin in 6 Refractory Ascites/HRS P atients* *(Data licensed from Dr. P. Angeli ); Source: Adapted from BioVie US Patent application 16/379,446 Angeli et al. Mean results during one month of therapy compared to month prior to starting therapy.. No serious drug - related side effects were reported in this study. Terlipressin is not available in the US 32

©2022 BioVie Inc. I Corporate presentation Source: JHEP 2019. Frequency of paracentesis over 30 days compared to average over 30 days during 3 - month period prior to therap y; (Chapman et al.. Terlipressin is not available in the US) Prospective study by Chapman et al. (Australia 2018) Pre - therapy: • 70% of patients required weekly large volume paracentesis (LVP) • 63 % poor muscle strength Results: • Median duration of CI terlipressin treatment: 51 days • 4 6 % average reduction in frequency of paracentesis • Significantly improved muscle strength and nutritional intake • No complications directly attributable to terlipressin Decreased Need for Paracentesis Change in frequency of paracentesis procedures Continuous Infusion Terlipressin in 19 Refractory Ascites/HRS P atients 33

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BioVie Inc. published this content on 29 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 June 2022 12:37:39 UTC.


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