Biovie Inc. · NASDAQ:BIVI
Biovie — Investor Presentation (March 2024)
34 slides from Biovie's investor presentation, Mar 6, 2024
Slide 1: Unlocking the science of longevity to develop transformative therapies
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 NE3107 modulates the production of TNFa. In clinical trials, many patients treated with NE3107 experienced: ~ Reduced inflammation and the associated insulin resistance ~ Improved cognition and function, lowered amyloid B and p-tau levels, and improved brain imaging scans in
Slide 4: Far-reaching impact of TNFa-mediated chronic low-grade inflammation
Far-reaching impact of TNFa-mediated chronic low-grade inflammation IKK, JNK Serine kinases + Cytokines + APP, SNCA + Chemokines + Others Diabetes Alzheimer’s Alzheimer’s Metabolic disorders: Parkinson's Parkinson's Metabolic disorders Various cancers Rheumatoid arthritis, Various autoimmune disease
Slide 5: NE3107's mechanism of action
NE3107’s mechanism of action fas : oe fa cs € Extracellular signals Insulin (0: eyes: chanckns, AP tingle te) rae NE3107 First-in-class molecule with desirable characteristics CetlSynapse growth, Inara facts ‘Small molecule; orally bioavailable (nak a oceans pra OF OS. IKKG. INK. yokes, ote) Crosses
Slide 6: NE3107 in Alzheimer's Disease
Slide 7: NE3107 modulates inflammation
NE3107 modulates inflammation reducing downstream cascade it the central hub, thereby potentially T0237, Salat, PUAD BEYZISS ‘ABBV-SE12, 18052, Semerinemab, BI6076, Zagotenemab, Lu AFST908, ACLS, IN63739057 Phospho-Tau ‘bac, BAN, adam ARON, ‘reruzsnad,CADTOS,earamab, LMA S1BHS,Donanoray L¥S572009, e
Slide 8: NM101 Phase 3 trial in Mild to Moderate Alzheimer's
NM101 Phase 3 trial in Mild to Moderate Alzheimer’s ‘APhase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Study of NE3107. 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 titration fo
Slide 9: Trial Summary
Trial Summary * NE3107 appears to be biologically active * Cognitive, functional, biomarker efficacy signal suggest that NE3107: - Has a treatment advantage equal to or greater than results reported from clinical trials from approved monoclonal antibody treatments; - Associated with a benign safety
Slide 10: NE3107 Advantage vs. Placebo Comparable to Approved Medications
Week 30 Suggest NE3107 Advantage vs. Placebo is Comparable to or Better than Results Reported from Clinical Trials by Approved Medications Change from baseline La Placebo Decline NE3107 NE3107 vs. Placebo Comparator (18 mos) CDR-SB +139 (lowerisimprovement) __(p=0.0125; n=26) ADAS-Cog12 +3.64 (lower
Slide 11: NE3107-treated Patients' Changes in CDR-SB Correlated with Key Biomarkers
NE3107-treated Patients’ Changes in CDR-SB Appears Correlated with Key Biomarkers TNFa Phospho-Tau AByo / AByo 065. 105. 0.08. 5 5 # ‘Slope =-0.002 os, 8 . 084 = op 00 R= 0.327: p= 0.299 g° B ® ode § . Rode oo % aot gue 5 CE Fee Pe Bead biniazatinniancinianncine oe 5 0004 . ‘Slope = 0.077 ° z 3 02 R
Slide 12: NE3107 Appears to Decrease Neuroinflammatory Processes Linking Nf-L and GFAP
NE3107 Appears to Decrease the Neuroinflammatory Processes that Link Nf-L and GFAP to Cognitive Decline placebo NE3107 204 «. Slope = 3.44 é Slope =-0.035 604 R=0.610; p= 0.002 20-4 R=-0.009; p= 0.968 * si 27 6° D g Ant SO? g eee 2 Zao « z wt al shade . 20. 20 " 5 Hy 3 NE3107 200 ‘Slope = 1.61 ® ‘0
Slide 13: Safety Profile
Safety Profile NE3107 Placebo Total NE3107 Placebo Total NE3107 Placebo Total ‘35% Tas 8B 79% ‘Ble - - _ ad 746 28% (©2024 Bile Ine. | Corporate presentation | 13
Slide 14: NE3107 in Longevity
Slide 15: Clean DVD leads to clear picture; scratches lead to skips
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
Slide 16: DNA methylation
DNA methylation en 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 h
Slide 17: 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 18: DNA methylation clocks measure extent of aging and biological function
DNA methylation “clocks” measure extent of aging and biological function Chronological Clocks wf Biological clocks Boone lok 309603 gone) : EES ae Se . mer —— f aes = 7 = as 353.98 244 ene) ergs mona ot 1090s ere) Bos tata Pres | Youn an ore ‘annan ooo | ; TA Cs 194 genes) M ~ Teco es Sete nn Sees ‘
Slide 19: NE3107-treated patients experienced significant age deceleration
NE3107-treated patients experienced significant “age deceleration” in a manner correlated to cognitive and functional improvements Age Deceleration! is used by longevity researchers? to measure the difference between a person's 10. biological age and the actual chronological age. Placebo NE3107 10 °
Slide 20: NE3107 in Parkinson's Disease
Slide 21: 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 NM — 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 a
Slide 22: NE3107-treated patients experienced fewer motor symptoms before morning dose
NE3107-treatment patients experienced fewer motor symptoms before morning drug administration Day 28 Improvement in Motor Control vs. Day 1 5 Patients Patients <70 years old § . NE3107 Placebo : “on” at t=0 5 ° : Total patients 19 19 : Pyvalue* 0.046 2 + Fioher's exact test 2 8 = o 1 3 4 to 1 2 3 H
Slide 23: Larger proportion of NE3107 patients had >30% improvements in motor control
Larger proportion of patients treated with NE3107 had >30% improvements in Percentage of patients experiencing >30% improvement at Day 28 vs. Day 0 I Lovodopa alone 1H NE3107+Levodopa, NE3107-*Levodope, <70 years old 18 motor control 0 Ps a S © a Ss » 10 i i) 889 bad 78 700 650 036 | S01 a 2 3 Hours
Slide 24: Desirable pharmacokinetics - no observed DDI
Desirable pharmacokinetics - no observed DDI 0-8 hr 234 ngh/mL (SD 22.38) Mean NE3107 ng/mL in Plasma 100.0 100 NE3107, ng/mL 005123 4 8 Day 14 hours post dose NE3107 Treated Plasma Levodopa 2000 Hr post Levodopa administration Levodopa ng/mL g —e-Day lave -eDay 14 ave Placebo Treated Plasma Levedop
Slide 25: BIV201 in Ascites
Slide 26: BIV201 Disease Target: Refractory Ascites
2 1 «ware intranet partntamic shut to chant od fw ound he er 2 Dameettom sapine Jn Gestroeneral 016) 690.6, Om ual of Hepat, Youn 53, samerans Wor ural ot Heptog, (7), 508-52, Saerathan Dtsch Mea Wecersety, Yume 139, pp. 2758-1762 aa Ges New Egan cua! of BIV201 Disease Target: Refractory Ascites Ref
Slide 27: 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 28: BIV201 Phase 2b trial
BIV201 Phase 2b trial 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 Cycle 1 (©2024 Bie Ie. | Corporate presentation
Slide 29: Change in ascites volume 28d pre- vs post-treatment
Change in ascites volume 28d pre- vs post-treatment Be eerie eran Seem 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 _vovie | (©2024 Bivie Ie. | Corporate presen
Slide 30: Next Steps: Phase 3 trial in decompensated liver cirrhosis
Next Steps: Phase 3 trial in participants with decompensated liver cirrhosis and ascites who have experienced a recent acute kidney injury ‘APhase 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 31: Commercial potential in US market alone
Commercial potential in US market alone* eam «D> GED $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-in cost vs. competit
Slide 32: Leadership Team
Leadership Team Deep expertise provides a strong foundation for success 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 Chris Reading, PhO, Neurodegenerat
Slide 33: Recap
Recap Our lead asset NE3107 modulates the production of TNFa. In clinical trials, many patients treated with NE3107 experienced: ~ Reduced inflammation and the associated insulin resistance ~ Improved cognition and function, lowered amyloid B and p-tau levels, and improved brain imaging scans in Alz
Slide 34: Thank You