Annovis Bio, Inc. · NYSE:ANVS
Annovis Bio — Corporate Update (January 2026)
26 slides from Annovis Bio's corporate update, Jan 28, 2026
Slide 1: Annovis Webinar January 28, 2026
NYSE: ANVS Annovis Webinar January 28, 2026 Presenter: Maria Maccecchini, Ph.D., President and CEO
Slide 2: Forward-Looking Statements
2 FORWARD - LOOKING STATEMENTS Forward Looking Statements and Other Important Cautions -- This presentation contains "forward - looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These s
Slide 3: Company highlights
3 Company highlights Capital - efficient approach Current shares outstanding 26.5m. Cash balance* $19m, d ebt $0 Raised $40m. in 2025 Drug candidate Our lead asset buntanetap is the only drug that improves cognition in AD and cognition and motor function in PD patients Late - stage opportunity Compl
Slide 4: Pipeline
Pipeline Buntanetap Indication Pre-clinical IND Phase 1 Phase 2 Phase 3 Alzheimer’s disease (AD) Parkinson's disease (PD) Parkinson's disease dementia (PDD) Combination therapies Buntanetap + Trulicity” Buntanetap + Viagra Trulicity® + Viagra Buntanetap { Traumatic Brain Injury (TB!) Stroke ~ ANVS 3
Slide 5: Summary of clinical studies
5 Over 1, 2 00 people treated with buntanetap Healthy volunteers Alzheimer’s disease Parkinson’s disease Summary of clinical studies N=22 2 studies Phase 1/2 N=17 1 study Phase 2 N=346 1 study Phase 2/3 N=760 (ongoing) 1 study Pivotal Phase 3 N=58 1 study Phase 2 N=523 1 study Phase 3 N=500 - 600 (o
Slide 6: Patent portfolio
Patent portfolio OLD NEW SEMI-CRYSTALLINE CRYSTALLINE FORM FORM EXTENSION AND COMBINATION PATENTS ---- Improved manufacturing 2005. Double and triple combinations with drugs for erectile dysfunction and weight loss - Neuropsychiatric diseases Brain Infections for crystal buntanetap Novel composition
Slide 7: Alzheimer's disease
Alzheimer’s disease
Slide 8: Phase 2/3 AD Study: Buntanetap improves cognition in mild AD
8 Phase 2/3 AD Study: Buntanetap improves cognition in patients with mild, not moderate, AD # comparing to baseline * comparing to placebo */# p<0.05 ### p<0.001 From the ITT population: - AD patients were selected by pTau217 inclusion/exclusion. - Mild and moderate AD were determined by MMSE select
Slide 9: Forest plot shows consistency and robustness of efficacy
% Slowing in Adj.MeanAdjusted Mean DiffNo. patients (Bun 30 mg,Placebo)Subgroup Overall Age >=65 Apolipoprotein E4 Carrier Non-Carrier BMI <30 >=30 Ethnicity Hispanic Or Latino Not Hispanic Or Latino Gender Female Male Medication with Psychoanaleptics with Antidepressants No Psychoanaleptics Race Bl
Slide 10: Biomarker data in mild AD patients
Neuronal damage Inflammation Neurotoxic proteins Biomarker data in mild AD patients (MMSE 21 - 24) 10 Reductions in neurotoxic proteins, inflammation, and neuronal damage
Slide 11: FDA-cleared pivotal Phase 3 study (ANVS-25001)
11 FDA - cleared pivotal Phase 3 study (ANVS - 25001): A randomized, double - blind, placebo - controlled, multicenter study of buntanetap in participants with early Alzheimer’s disease R 1:1 Placebo QD 30mg buntanetap QD 8 weeks screening 6/18 months treatment n=380 n=380 N=760 Key inclusion c rite
Slide 12: Milestones toward approval for Alzheimer's disease
6 - months 18 - months NDA (Q4 2026) NDA (Q4 2027) Milestones toward approval for Alzheimer’s disease (AD) 12 $100 billion/US estimated Market $7 billion/US $20 billion (20%) Our market share $1.4 billion (20%) We are here Market approval
Slide 13: Progress of the pivotal Phase 3 trial in early AD
clinical sites in the U.S. 83 total patients 760 Progress of the pivotal Phase 3 trial in early AD enrolled 40% 13
Slide 14: Parkinson's disease
Parkinson’s disease
Slide 15: Upcoming milestones for Parkinson's program
Upcoming milestones for Parkinson’s program 15 We are here We are here
Slide 16: FDA-approved PD Open Label Extension study design
16 FDA - approved PD Open Label Extension (OLE) study design Early AD Cohort 1: Invitation Only Cohort 2: DBS Patients 6 weeks screening 36 months treatment N: 500 - 700 Key Inclusion Criteria: • Adults aged up to 85 years • Hoehn and Yahr stage 1 - 3 • MMSE 21 - 30 at screening Cohort 1 : Diagnosis
Slide 17: Progress of the OLE trial in PD
clinical sites in the U.S. 25 total patients ~500 Progress of the OLE trial in PD Screening began 17
Slide 18: Buntanetap improved cognition in PD patients
Buntanetap improved cognition in the ITT as well as in MMSE>20. The most pronounced improvement was seen in amyloid - positive, tau - positive PD patients 18 10 mg p = 0.07 20 mg p= 0.57
Slide 19: Biomarker data in cognitively impaired PD patients
Biomarker data in cognitively impaired PD patients (MMSE >20) 19 Reductions in plasma levels of pTau217, total tau, and brain - derived (BD) tau
Slide 20: Update on the FDA meeting for PDD study
Update on the FDA meeting for PDD study 20 • Cognitive outcome (MMSE) and plasma biomarkers (pTau217) from previous studies opened the door for a new trial – to test buntanetap in amyloid positive PD patients with Parkinson’s disease dementia (PDD). • We received guidance from the FDA in January abo
Slide 21: Summary: buntanetap and cognition in Alzheimer's and Parkinson's disease
Summary: buntanetap and cognition in Alzheimer’s and Parkinson’s disease
Slide 22: Unified and reproducible pattern in improving cognition across AD and PD
Buntanetap shows a unified and reproducible pattern in improving cognition across AD and PD 22 Unified treatment pattern Buntanetap demonstrates the most pronounced cognitive benefit in patients with mild dementia (MMSE >20) and biomarker - confirmed presence of amyloid and tau.
Slide 23: Fast improvement of cognition across four studies
Buntanetap shows a fast improvement of cognition across four studies in Alzheimer’s and Parkinson’s patients Phase 1/2 studies in early AD and PD 1 month of treatment Phase 2/3 study in early AD 3 months of treatment Phase 3 study in early PD 6 months of treatment 23
Slide 24: Disease modification vs symptomatic benefit in Alzheimer's disease
24 Disease modification vs symptomatic benefit in the treatment of Alzheimer’s disease Kennedy GJ. Primary Psychiatry. Vol 14. No 11. 2007, adapted Annovis
Slide 25: Summary
Summary 25 1. The enrollment for the pivotal Phase 3 study in early AD is actively progressing, with the full recruitment completion estimated in Spring 2026. 2. The OLE PD study has begun screening patients. 3. The FDA agrees with us conducting a PDD study and we are discussing the details with KOL
Slide 26: Thank you
ANNOVIS Thank you