Biovie Inc. · NASDAQ:BIVI
Biovie — Investor Presentation (May 2021)
52 slides from Biovie's investor presentation, May 17, 2021
Slide 1: Developing Transformative Therapies to Overcome Chronic Debilitating Diseases
biovie Developing Transformative Therapies to Overcome Chronic Debilitating Disea Corporate Presentation May, 20217
Slide 2: Forward-looking statements
Forward-looking statements biovie ‘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 diffe
Slide 3: Investment Highlights
| Investment Highlights | Multiple shots on goal focused on unmet medical needs: neurodegenerative, advanced liver disease, oncology BIV201: Orphan drug in Phase 2b for refractory Ascites; HRS-AK| trials planned. Ascites readout anticipated in early 2022 NE3107: inhibitor of pathologic inflammation
Slide 4: Leadership Team
Leadership Team 8 © Cuong Do President &Chiet Executive Officer 30 yearsin biopharma & technology President, Smeung Global Strategy Group Chiet strategy Otter or Merck Senior partner at Mekinsey Company Jonathan Adams Uver Cirhosis Program 20" yearsin biopharma Founded LAT Pharma (BioVie predecessor
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Slide 6: Disease Target: Refractory Ascites
Disease Target: Refractory Ascites biovie Refractory ascites patients typically undergo paracente: 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
Slide 7: BIV201: Continuous Infusion Terlipressin
BIV201: Continuous Infusion Terlipressin biovie + Terlipressin was first approved in Germany in 1980s, to treat bleeding esophageal varices (BEV) + Approved for BEV and hepatorenal syndrome (HRS) in European & Asian hospitals (40+ countries) + Administered via 1-2 mg bolus injections every 4-6 hours
Slide 8: Novel Prefilled Syringe with Patent-pending Liquid Formulation
Novel Prefilled Syringe with Patent-pending Liquid Formulation + Global PCT filed to protect our novel liquid formul: + Improved safety: Eliminates mixing minute quantities of powder terlipressin that could result in medication errors or sterility loss + Enhanced convenience: Simply inject fluid int
Slide 9: BioVie Phase 2a trial results: BIV201 Pharmacokinetics
BioVie Phase 2a trial results: BIV201 Pharmacokinetics Comparison of the PK Profile of Terlipessin Administered by Continuous Infusion of Intermittent IV Boluses. Continuous low blood levels of terlipressin versus potentially dangerous spikes with IV- bolus dosing Source: Bie poster presentation at
Slide 10: Continuous Infusion Terlipressin in Refractory Ascites/HRS Patients
Continuous Infusion Terlipressin in 19 Refractory Ascites/HRS Patients biovie (Chapman et al.) Pre-therapy: Decreased Need for Paracentesis + 70% of patients required weekly large volume ‘Change in frequency of paracentesis procedures paracentesis (IVP) + 63% poor muscle strength 29) Results: 5 + Me
Slide 11: BIV201 Development Plans
BIV201 Development Plans biovie Ascites Revised Phase 2 protocol and CMC package covering prefilled syringe cleared by FDA. 20 o receive BIV201 therapy + standard of care (SOC); 410 to receive SOC only (control group) + Primary composite endpoint: Incidence of ascites- related complications over 180
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Slide 13: Inflammation
Inflammation biovie * Inflammation is the result of the body's natural protective processes Insults Responders Master Alarms —_Pro-inflammatory ‘Pathogens + Blood proteins + NFxBtansenption factors sTrauma = Platelets actors + oytokines ‘Ischemia Granulocytes + Ondatve stress | Chemoxines. +Suress +
Slide 14: Inflammation and disease pathology well established in many areas
Inflammation and disease pathology well established in many areas Bi isiagg] [Prove = A EES| | Exploiting Common Aspects of |co-merbiaty and systemic infammation as divers} | Obesity and Alzheimer's Disease lof cognitive decline: new experimental models | | Se %emnsu4newau Tey ladopting a broader pa
Slide 15: Neuroinflammation drives disease pathology
Neuroinflammation drives disease pathology Inflammatory stimulntates. ERK and NFxB activationperpetuates _.leadingtoinflammation _.resutingin provinflammatory easeade Sndinslinresistance.... _ dsease pathology Mites ‘ta scien ‘Arnis ta here ss = tea hon vere intonation reamtioor Gyokines and Mp CNS
Slide 16: Extracellular Signal-Related Kinase (ERK)
Extracellular Signal-Related Kinase (ERK) Homeostatic Inflammatory Pathways Pathways via Ras/Raf/Mek via NFkB Critical player for both homeostasis and inflammation (and resulting inflammation-induced insulin resi
Slide 17: KOL Panel Excerpts from B. Riley Neuroscience Conference, 2021
the “Now” - KoL Panel Excerpts from B. Riley Neuroscience biovie | Forgetting the “Past” So that We Can Remember Conference, 2021 “1 saw that there was a drug by NeurMedix called NE3107 which was just authorized for a pivotable Alzheimer’s Phase 3 trial. What intrigued me about it is because it affe
Slide 18: NE3107: A Differentiated Molecule
NE3107: A Differentiated Molecule First-in-class molecule with desirable characteristics + Small molecule + Crosses blood-brain barrier + Excellent safety profile demonstrated in pre-clinical and clinical trials, + Blocks neuroinflammation and insulin-resistance at the right time/place in pathologic
Slide 19: NE3107 Selectively Inhibits ERK Pathological Inflammatory Cascade (EPIC)
NE3107 Selectively Inhibits ERK Pathological blovie Inflammatory Cascade (EPIC) NE3107 reduces ERK activation ... a PERK coms. smves206 Normatzad Fold Expression 0 8 15 30 60 120 .»NFKB activity, and nuclear locali Prpetuates intamnmatory Effects Breaking the cascade reduces inflammation and restore
Slide 20: By blocking ERK activation, NE3107 prevents downstream impact
| By blocking ERK activation, NE3107 prevents downstream impact Inflammatory stimuli initiates ERK and NFxB activation perpetuates. eadingtoinflammation _..resultingin soa pro-inflammatory cascade. ‘and insulinresistance. disease pathology a NE3107, nam "SED ‘awd beta iss =>9¢>5 insulin vesiarce Neu
Slide 21: NE3107 Has Demonstrated Broad Applicability
NE3107 Has Demonstrated Broad Applicability + NE3107 decreased disease in models of arthritis, insulin resistance, type 1 and 2 diabetes, ulcerative colitis, COPD, pleurisy, multiple sclerosis, optic neuritis, glaucoma and Parkinson’s disease * NE3107 demonstrated broad impact on inflammation + Redu
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Slide 23: NE3107's neuroprotective properties
NE3107’s neuroprotective properties biovie Decreased neuretropinrecepter (p78) and Decreasedactvatedmicrogia evils resuserpetel APA) feeitioreteaced Decreased Inflammatory NFxB in inflamed optic nerve head: increased homeostatic NFxB in retina ital Decreased C1q 2a
Slide 24: NE3107's ability confirmed in Phase 2 trial with impaired glucose tolerance patients
NE3107’s a confirmed in Phase 1 trial with impaired glucose biovie tolerance patients Improved insulin-dependent glucose disposal in 48 obese, inflamed subjects Placebo Baseline M HE3286 7? £054,P <0.0001) o cy 123.45 67 8 9 10 Baseline M Day 29 M Vs 4 Day 29 M Value Change ry Day 29 Glucose disposa
Slide 25: NE3107's ability to enhance insulin sensitization confirmed in Phase 2 trial with T2D patients
NE3107’s ability to enhance insulin sensitization confirmed in Phase 2 trial with T2D patients Improved the homeostaticmodel s-decreased postprandial glucose... decreased HbA1c assessment of insulin resistance... Ti voor — 7 Tot ONO Dee “rao Tar 6
Slide 26: Insulin sensitizing improvement also brought improvements in AD indicators
Insulin sensitizing improvement also Ol brought improvements in AD indicators Ina Phase 2 study 48 obese subjects with impaired glucose tolerance, NE3107... Increased insulin sensitivity... increased HDL .. sndecreased CRP. uli and inereased adiponectin Adiponectin DPicebo (@ay 28 Change) Mbics2se :
Slide 27: Proceeding Pivotal Phase for Alzheimer's Disease
Proceeding Pivotal Phase 3 for brovie Alzheimer’s Disease —— + NE3107 + Reduces inflammation and enhances insulin sensitivity, both of which have been shown to reduce AD pathology. NE3107 blocks EPIC, which is upstream from Amyloid beta and phospho-tau, and thus further reduces inflammation + Has de
Slide 28: NM101: a Phase 3 trial in mild to moderate Alzheimer's disease
NM101: a phase 3 trial in mild to moderate blovie Alzheimer’s disease, NCT04669028 — ‘A Phase 3, Double-blind, Randomized, Placebo controlled, Parallel Group, Multicenter Study of NE3107 in Patients who have Mild to Moderate AD * Plvta study for Aleimers eae. Twowests echo Smg and 10mg BID dose tiat
Slide 29: Targeting Neuroinflammation in Alzheimer's Disease
Targeting Neuroinflammation in . 4 Tat biovie Alzheimer’s Disease ——S + Extensive study data supports reducing neuroinflammation as the key to slowing/reversing cognitive decline + Other companies focused on this target: andi Denali Impacts TNF mediated Therapeutics ONL788 ——_Earlyclinicalt —peuroin
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Slide 31: Remarkable similarities between neurodegenerative diseases
Remarkable similarities between brovie neurodegenerative diseases + Neuroinflammation and oxidative stress are common features in the major neurodegenerative diseases, Alzheimer’s, Parkinson’s, frontotemporal lobar dementia and ALS (and TBI) + Remarkable parallels exist between AD and PD + Activated
Slide 32: Low dopamine environment and inflammation are required to drive parkinsonism
Low dopamine environment and inflammation blovie are required to drive parkinsonism aan! 5 : Sen a thats ‘i. ro en era aft wa H {Ht Hae feat, AFA iS i t + Reduction of inflammation resulting from insulin- resistance reduced Parkinson's motoric symptoms 22
Slide 33: NE3107 has similar promotoric activity to L-dopa in rodent and marmoset models
NE3107 has similar promotoric activity to L-dopa in rodent and marmoset models vir tome Te Diamant tated ek 20 oe =o g £ aw aa fs esr 3 a j en sof ae i L-Dopa an NES107 combinations o- + 0- + + = a oe ae eee Tals Wolke vel WO NE3107’s promotoric effects observed within 4 days of treatment 236 oct 20
Slide 34: NE3107 decreases L-Dopa-induced dyskinesia (LID)
NE3107 decreases L-Dopa-induced Wi dyskinesia (LID) Distribution of AIMS Scores 307 NE3107 Score Frequency ° 1.2845 67 8 9 101112 13 14 15 16 17 18 19 20 es <————— ystineia. ——————+ore Abnormal Involuntary Movement Scale (AIMS) a
Slide 35: NE3107 preserved TH+ neurons in MPTP marmosets
NE3107 preserved TH+ neurons in MPTP marmosets Control moneys (M09100 and M1100) fy 2 f ‘ 8 seo \ 5 v0 HEs286 (M11007) ‘Amantadine (10084) 5 2
Slide 36: Proceeding to clinical development for Parkinson's disease
Proceeding to clinical development for Bowe Parkinson’s disease — + NE3107 reduces inflammation and enhances insulin sensitivity, both of which has been shown. to reduce PD pathology + Reduction of inflammation itself may be beneficial since both inflammation and low dopamine environment are require
Slide 37: Parkinson's disease clinical development program
. Loos oe Parkinson’s disease clinical Dome development program + NM201 Phase 4b: Satisfy FDA requirement for drug-drug interaction study with L- Dopa and assess NE3107 promotoric and anti-LID activity as a go/no-go decision for Phase 2 * Part A: 30 patients with defined L-Dopa “off state’, 2:1 acti
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Slide 39: Macrophage and MDSC inflammation in cancer
Macrophage and MDSC inflammation in cancer NFKB/ERK signaling is, implicated in many cancers Eo
Slide 40: NE3107 in Myeloma
NE3107 in Myeloma biovie + NE3107 inhibits: + Activation of NFkB/ERK, TNFa. and MCP-1 + IFNa-stimulated IL6 in human myeloma cells + NE3107 has potential to inhibit proliferation and induce apoptosis in MM + Inhibiting cytokine and chemokine production in myeloma-associated macrophages and MDSC * Bl
Slide 41: NE3107 in Prostate Cancer
| NE3107 in Prostate Cancer biovie + Macrophages and MDSC secrete IL23 and IL6 in the tumor microenvironment. + Activates androgen receptor pathways in CRCP (in the absence of androgens) + NE3107 inhibits NFkB/ERK signaling that drives IL23 production + Androgen deprivation leads temporarily ceases
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Slide 43: Catalysts & Anticipated Timelines (US)
Catalysts & Anticiated Timelines (US) biovie
Slide 44: Portfolio Revenue Potential
Portfolio Revenue Potential Conservative Company Estimates BIV201: Refractory Ascites BIV201: HRS-AKI NE3107: Alzheimer’s NE3107: Parkinson's NE3107: Oncology Intellectual Property ‘Orphan Dru: Patent- ‘ending formation ‘Orphan Drug Patent- ‘ending formation Compound patent ‘hu 2034+ Compound patent
Slide 45: Multiple shots on goal focused on unmet medical needs
| w | Multiple shots on goal focused on unmet medical needs: neurodegenerative, advanced liver disease, oncology BIV201: Orphan drug in Phase 2b for refractory Ascites; HRS-AK| trials planned. Ascites readout in early 2022 NE3107: inhibitor of pathologic inflammation and insulin resistance without t
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Slide 47: Ascites & HRS Epidemiology Estimates
Ascites & HRS Epidemiology Estimates Refractory & us Japan v 270,002 Sat cr TBD Europe VW 800,000" 164 33 Ted China v 2million* 500 100 TBD
Slide 48: Liver Cirrhosis Progression and Onset of Ascites
Liver Cirrhosis Progression: and Onset of Ascites Typical patient experience: + Liver cirrhosis worsens over decades + Ascites (detected by ultrasound) is the most common first major complication? = Initial treatment off label diuretics + Signals liver decompensation and patients at risk of: ~ GUvar
Slide 49: NE3107 blocks inflammatory, but not homeostatic ERK signaling
NE3107 blocks inflammatory, but not homeostatic ERK signaling o + Insulin Receptor Substrate (IRS) IRS1/2 can be activated by _Cliwsx2> insulin via tyrosine phosphorylation, requires homeostatic ERK eo * IRS1/2 also phosphorylated by proinflammatory serine i kinases p38 and JNK, requires inflammator
Slide 50: NE3107 vs. Others
NE3107 vs. Others Senecnerb Acta ronotecexane oo. Sates Boerne adres nants eer tana ‘rer tat sty ‘Agata sy at master iol pasty tng smelters = Oraanat molede MENS cst {hesnthoo cular slg gst on rans * Pane As20) pachrgn aces APP dnt onset sei Sorte ‘anata ul nearer nse ese maton ental « Recghemetanim
Slide 51: NeurMedix Transaction
| NeurMedix Transaction E3107 and Related Molecules Research Expertise 4 z Clarence Ahlem,COO Inhibitors ofthe pathological 0 GE ORES inflammatory cascade Recon tae ie + Leadingexpertsonthe Gompelingarimalandcinieal | |” recites and pathways + Deep experience working with theassets Both scientists e
Slide 52: Deal Overview
Deal Overview Upfront Considerations Contingent Milestones + Atclosing + Payable in shares; capped at 87.5% + 8,361,308 newly issued shares ownership + Approximately $3.0 million in cash + 4.5 million shares upon hitting endpoints + Additional $7.3 million cash in pivotal trials payment payable afte