BioVie Inc. · NASDAQ:BIVI
BioVie — Investor Presentation (April 2025)
44 slides from BioVie's investor presentation, April 2025
Slide 1: Unlocking the science of longevity to develop transformative therapies
Unlocking the science of longevity to develop transformative therapies Corporate Presentation • April 2025
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains statements about BioVie’s future expectations, plans, strategies and prospects which constitute forward-looking statements. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Refo
Slide 3: Overview
Overview Our lead asset bezisterim (formerly NE3107) modulates the production of TNFα. In clinical trials, many patients treated with bezisterim experienced: ⎻ Reduced inflammation and the associated insulin resistance ⎻ Improved motor control and “morning on” symptoms in Parkinson’s disease (PD) ⎻
Slide 4: Far-reaching impact of TNFα-mediated chronic low-grade inflammation
Far-reaching impact of TNFα-mediated chronic low-grade inflammation INSULIN RESISTANCE Diabetes Metabolic disorders Parkinson’s DNA METHYLATION IKKb, INFLAMMATION JNK Systems dysregulation of gene expression Cytokines APP, SNCA Accelerated aging Chemokines Others Various cancers
Slide 5: Bezisterim's mechanism of action
Bezisterim’s mechanism of action Bezisterim First-in-class molecule with desirable characteristics Small molecule; orally bioavailable Crosses blood-brain barrier, thus CNS and peripheral applications Bezisterim Reduces ERK Activation Bezisterim Reduces NFκB Activation No safety issues identified to
Slide 6: Bezisterim in Parkinson's Disease
Bezisterim in Parkinson’s Disease
Slide 7: Low Dopamine and inflammation are required to develop Parkinson symptoms
Low Dopamine and inflammation are required to develop Parkinson symptoms in patients Intranasal Insulin treatment reduced inflammation and improved motor activity 60 ✱ Insulin Baseline 40 Insulin Post-Treatment Placebo Baseline Score 20 Placebo Post-Treatment 0 -20 a II III I i S es S S R R R in PD
Slide 8: Bezisterim has similar promotoric activity to L-dopa in rodent and marmoset models
Bezisterim has similar promotoric activity to L-dopa in rodent* and marmoset* models Funded by MPTP Mouse MPTP Marmoset treated at Week 8 4 * * Placebo Mean Disease Score 3 Bezisterim NE3107 * L-Dopa 2 ** NE3107+L-Dopa 1 L-dopa and bezisterim combination is better than either drug alone 0 MPTP + Wee
Slide 9: Bezisterim decreases L-Dopa-induced dyskinesia in marmosets
Bezisterim decreases L-Dopa-induced dyskinesia (LID) in marmosets* Funded by Distribution of AIMS Scores 30 Bezisterim 25 Score Frequency 20 15 Placebo 10 5 Amantadine 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Less Dyskinesia More Abnormal Involuntary Movement Scale (AIMS) ©2025 BioVie In
Slide 10: Bezisterim preserved ~2X TH+ neurons in MPTP marmosets
Bezisterim preserved ~2X TH+ (dopaminergic) neurons in MPTP marmosets* Funded by Control moneys (M09100 and M11008) Bezisterim Amantadine (M10084) Vehicle Amantadine Bezisterim ©2025 BioVie Inc. I Corporate presentation 10
Slide 11: Parkinson's Disease Clinical Development Program
Parkinson’s Disease Clinical Development Program 40 patients with defined L-dopa “off state”, 1:1 active: placebo, NM201 Phase 2 20 mg BID for 28 days • Satisfying FDA requirement for • Safety assessments: Standard drug-drug interaction study measures of patient health, L- with L-dopa dopa PK and DD
Slide 12: Fewer motor symptoms before morning drug administration
Bezisterim-treatment patients experienced fewer motor symptoms before morning drug administration Day 28 Improvement in Motor Control vs. Day 1 0 0 UPDRS Part 3 Score – Day 28 change from Day 1 All Patients Patients <70 years old Bezisterim Placebo -5 -5 “On” at t=0 6 0 -10 -10 Total patients 20 19
Slide 13: Larger proportion of patients had >30% improvements in motor control
Larger proportion of patients treated with bezisterim had >30% improvements in motor control Percentage of patients experiencing >30% improvement at Day 28 vs. Day 0 100 Levodopa alone Bezisterim + Levodopa 88.9 90 Bezisterim + Levodopa, <70 years old 80.0 80 77.8 77.8 70.0 70 66.7 66.7 65.0 Percent
Slide 14: Desirable pharmacokinetics – no observed DDI
Desirable pharmacokinetics – no observed DDI 0-8 hr 231 ngh/mL (SD 22.38) Mean bezisterim ng/mL in Bezisterim Treated Plasma Levodopa Plasma 2000 Levodopa ng/mL 100.0 1500 bezisterim, ng/mL 1000 500 10.0 0 0 0.5 1 2 3 4 8 Hr post Levodopa administration 01.0 Day 1 ave Day 14 ave 0 0.5 1 2 3 4 8 Day
Slide 15: PD Clinical Development Plan
PD Clinical Development Plan NE3107-PD-202 (FPFV 1Q25) NE3107-PD-301 (conceptual) Objective • Demonstrate motoric impact as Demonstrate QOL, motoric and disease monotherapy treatment progression benefits • Forecast potential impact on disease progression with DNA methylation changes Phase 2 3 N, 1:1
Slide 16: Bezisterim in Long COVID
Bezisterim in Long COVID
Slide 17: Long COVID
Long COVID • Persistent symptoms of at least 3 months following SARS-CoV-2 infection • Most common symptoms brain fog, fatigue and post-exertional malaise • Currently 17 million adults in US suffering from Long COVID • Despite decreasing incidence due to milder SARS-CoV-2 variants and vaccination, t
Slide 18: Why study Bezisterim in Long COVID?
Why study Bezisterim in Long COVID? • Sustained inflammation through TLR4 / RAGE loop leads to symptoms of Long COVID – Spike protein persists in circulation after COVID and can cross the BBB – Spike protein induces cognitive dysfunction via TLR4 activation – TLR variant associated with Long COVID c
Slide 19: NE3107-LC-201 Trial Design
NE3107-LC-201 Trial Design: Double-blind, placebo-controlled, 12-week treatment period Screening Period Treatment Period Follow-Up Period Up to 4 Weeks 12 Weeks 4 Weeks Randomization NE3107, 20 mg BID twice a day Assessment Safety 1:1 of Eligibility Follow-up Placebo, 20 mg BID twice a day Visit 1 V
Slide 20: Bezisterim in Alzheimer's Disease
Bezisterim in Alzheimer’s Disease
Slide 21: Bezisterim modulates inflammation at the central hub
Bezisterim modulates inflammation at the central hub, thereby potentially reducing downstream cascade Tau mRNA TRx0237, Salsalate, Ionis MAPTRx APP mRNA PU-AD, BEY2153 ABBV-8E12, BIIB092,Semorinemab, Buntanetap AAV-rh.10h COR388 Tangles Phospho-Tau Tau BIIB076, Zagotenemab, Lu AF87908, ACI-35, JNJ-6
Slide 22: NM101 Phase 3 trial in Mild to Moderate Alzheimer's
NM101 Phase 3 trial in Mild to Moderate Alzheimer’s A Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Study of bezisterim. Enrolled 439 Patients who have Mild to Moderate AD • Pivotal study for Alzheimer’s disease. Two weeks each of 5 mg and 10 mg BID dose titratio
Slide 23: Trial Summary
Trial Summary • Bezisterim appears to be biologically active • Cognitive, functional, biomarker efficacy signal suggest that bezisterim: – Has a treatment advantage equal to or greater than results reported from clinical trials from approved monoclonal antibody treatments; – Associated with a benign
Slide 24: Week 30 bezisterim advantage vs. placebo comparable to approved medications
Week 30 Suggest bezisterim Advantage vs. Placebo is Comparable to or Better than Results Reported from Clinical Trials by Approved Medications Change from baseline Placebo Decline Bezisterim Bezisterim vs. Placebo Comparator (18 mos) CDR-SB +1.39 +0.44 -0.95 (68%) -0.45 (27%)1 (lower is improvement)
Slide 25: Changes in CDR-SB appear correlated with key biomarkers
Bezisterim-treated Patients’ Changes in CDR-SB Appears Correlated with Key Biomarkers TNFα Phospho-Tau Aβ42 / Aβ40 Improvement Improvement Slope = -0.002 R = -0.327; p = 0.299 Aβ42 / Aβ40 CFB TNFα CFB pTau CFB Improvement Slope = 0.077 R = 0.466; p = 0.244 Slope = 0.047 R = 0.325; p = 0.140 CDR-SB C
Slide 26: Bezisterim decreases neuroinflammatory processes linking Nf-L and GFAP to cognitive decline
Bezisterim Appears to Decrease the Neuroinflammatory Processes that Link Nf-L and GFAP to Cognitive Decline Placebo Bezisterim Slope = 3.44 Slope = -0.035 R = 0.610; p = 0.002 R = -0.009; p = 0.968 Nf-L CFB Nf-L CFB Nf-L CDR-SB CFB CDR-SB CFB Placebo Bezisterim Slope = 1.61 R = 0.069; p = 0.761 GFAP
Slide 27: Safety Profile
Safety Profile NE3107 Placebo Total NE3107 Placebo Total NE3107 Placebo Total COVID-19 9.5% 17.6% 13.2% Atrioventricular block first degree 2.4% 0.0% 1.3% Hypothyroidism 2.4% 0.0% 1.3% Urinary tract infection 7.1% 8.8% 7.9% Bile duct stone 0.0% 2.9% 1.3% Hypoxia 0.0% 2.9% 1.3% Blood thyroid stimulat
Slide 28: Bezisterim in Longevity
Bezisterim in Longevity
Slide 29: Impact of wear & tear on a laser's ability to decode DVDs
Clean DVD leads to clear Scratches & smudges lead picture and sound to skips and blurs Impact of wear & tear on a laser’s ability to decode DVDs Quality of picture is dependent on the laser’s ability to clearly decode the disk … The same thing happens in our body ©2025 BioVie Inc. I Corporate presen
Slide 30: DNA methylation
DNA methylation DNA methylation happens when methyl groups are added to our DNA – DNA methyltransferases add methyl groups to DNA – Functionally the equivalent of scratches and smudges on a DVD surface – The methyl groups interfere with RNA polymerase’s ability to decode DNA DNA methylation may happ
Slide 31: Observations about DNA methylation
Observations about DNA methylation • DNA methylation increases as we age • DNA methylation can be affected by behavioral (diet, exercise) and environmental factors • DNA hypermethylation is associated with a large number of disease conditions, including various forms of cancers, age-related cognitiv
Slide 32: DNA methylation clocks measure extent of aging and biological function
DNA methylation “clocks” measure extent of aging and biological function Chronological Clocks Biological clocks Bocklandt clock 3 CpGs (3 genes) Saliva Koch/Wagner age measure Algorithm selects CpGs 5 CpGs (5 genes) Associated with Various cell types Yang Clock (epiTOC) Florath’s age predictor 385 C
Slide 33: Bezisterim-treated subjects showed a lower biological age than placebo
Bezisterim-treated subjects showed a lower biological age than placebo subjects Age Deceleration1 is used by longevity researchers2 to measure the difference between a person’s biological age and the actual chronological age. Skin SkinAge AgeClock Clock PhenoAge Clock GrimAge Clock HannumAge Clock I
Slide 34: BIV201 in Ascites
BIV201 in Ascites
Slide 35: BIV201 Disease Target: Refractory Ascites
BIV201 Disease Target: Refractory Ascites 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 • Th
Slide 36: Prefilled Syringe with Patent-pending Liquid Formulation
Prefilled Syringe with Patent-pending Liquid Formulation 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 lo
Slide 37: BIV201 Phase 2b trial
BIV201 Phase 2b trial Originally targeted 30 patients randomized 2:1 Paused enrollment based on encouraging data from the first 15 patients informing next steps – 10 randomized to BIV201; 5 randomized to standard of care – 5 completed 2 X 28-day cycles – 5 discontinued treatment during or at end of
Slide 38: Change in ascites volume 28d pre- vs post-treatment
Change in ascites volume 28d pre- vs post-treatment 53% reduction in ascites volume among patient completing BIV201 treatment 15% reduction among patients who started but did not complete treatment 3.1% increase for SOC patients p<0.001 ©2025 BioVie Inc. I Corporate presentation 38
Slide 39: Next Steps: Phase 3 trial in decompensated liver cirrhosis and ascites
Next Steps: Phase 3 trial in participants with decompensated liver cirrhosis and ascites who have experienced a recent acute kidney injury A Phase 3 randomized, open-label study evaluating the safety and efficacy of BIV201 continuous infusion compared to standard of care (SOC) alone to reduce furthe
Slide 40: Commercial potential in US market alone
Commercial potential in US market alone* Alzheimer’s Parkinson’s Ascites $30B $3B $1.6B Annual sales for every Annual sales for every US peak sales 1 million people treated 100,000 people treated 45% market penetration 15% market penetration 10% market penetration $45K/year $30K/year much lower all-
Slide 41: Leadership Team
Leadership Team Deep expertise provides a strong foundation for success Cuong Do, President & Chief Executive Officer Joseph Palumbo, MD, EVP, R&D and Chief Medical Officer 30+ years in biopharma & technology 30+ years treating patients; 25+ years in biopharma President, Samsung Global Strategy Grou
Slide 42: Capitalization Table
Capitalization Table March 31, 2025 Common shares outstanding 18,524,738 Warrants (WAEP $3.50) 9,600,564 Options ( WAEP $29.47) 887,247 Restricted Stock units 130,618 Fully dilluted shares outstanding 29,143,166 Market Cap (March 31, 2025 close price $0.98/share) $ 18,154,243 ©2025 BioVie Inc. I Cor
Slide 43: Overview
Overview Our lead asset bezisterim (formerly NE3107) modulates the production of TNFα. In clinical trials, many patients treated with bezisterim experienced: ⎻ Reduced inflammation and the associated insulin resistance ⎻ Improved motor control and “morning on” symptoms in Parkinson’s disease (PD) ⎻
Slide 44: Thank You
Thank You