Biovie Inc. · NASDAQ:BIVI
Biovie — Investor Presentation (June 2022)
33 slides from Biovie's investor presentation, Jun 29, 2022
Slide 1: Corporate Presentation June 2022
Developing Transformative Therapies to Overcome Chronic Debilitating Diseases Corporate Presentation • June 2022
Slide 2: Forward-looking statements
©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
Slide 3: Highlights
©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 i
Slide 4: Catalysts & Anticipated Timelines (US)
©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
Slide 5: Portfolio Revenue Potential
©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 NE
Slide 6: Roles of Inflammation and Insulin Resistance Well Established in AD Progression
©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
Slide 7: Extracellular Signal-Regulated Kinase (ERK)
©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 signal
Slide 8: NE3107 Blocks Inflammatory, but not Homeostatic ERK Signaling
©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 wit
Slide 9: Prior NE3107 Clinical Studies
©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
Slide 10: Rationale for NE3107 in Alzheimer's disease
©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 enha
Slide 11: Phase 3 Study of NE3107 in Mild to Moderate AD
©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 we
Slide 12: Investigator-Initiated Exploratory Biomarker Study
©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
Slide 13: Remarkable Similarities Between Neurodegenerative Diseases
©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 i
Slide 14: Proceeding to Clinical Development for Parkinson's Disease
©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 b
Slide 15: Parkinson's Disease Clinical Development Program
©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 - motori
Slide 16: BIV201 Disease Target: Refractory Ascites
©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):11
Slide 17: Prefilled Syringe with Patent-pending Liquid Formulation
©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 qu
Slide 18: BIV201 Development Plans
©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 re
Slide 19: Leadership Team
©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 & Psyc
Slide 20: Thank You
Thank You 20
Slide 21: Improved insulin-dependent glucose disposal in obese, inflamed subjects
©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 clam
Slide 22: Phase 1 results in obese subjects with impaired glucose tolerance
©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
Slide 23: Decreased insulin resistance in inflamed T2D patients
©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 … decrea
Slide 24: Inflammation drives systems dysregulation
©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 g
Slide 25: NE3107 decreased systems dysregulation in Phase 2 T2D study
©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
Slide 26: Systemic inflammation and co-morbidity as drivers of cognitive decline
©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
Slide 27: Targeting Neuroinflammation in Alzheimer's Disease
©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
Slide 28: NE3107 promotoric activity in rodent and marmoset models
©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
Slide 29: NE3107 decreases L-Dopa-induced dyskinesia in marmosets
©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
Slide 30: NE3107 preserved TH+ neurons in MPTP marmosets
©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)
Slide 31: BioVie Phase 2a trial results: BIV201 Pharmacokinetics
©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. Sim
Slide 32: Continuous Infusion Terlipressin in Refractory Ascites/HRS Patients
©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
Slide 33: Decreased Need for Paracentesis
©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 - therap