Annovis Bio, Inc. · NYSE:ANVS
Annovis Bio — Corporate Update (December 2024)
23 slides from Annovis Bio's corporate update, Dec 11, 2024
Slide 1: Development path to NDA for Alzheimer's and Parkinson's disease: Investor Update
December 11, 2024 Development path to NDA for • Alzheimer’s disease • Parkinson’s disease Investor Update
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: Multiple neurotoxic proteins are implicated in Alzheimer's disease
3 Multiple neurotoxic proteins are implicated in Alzheimer’s disease Adapted from R. Peterson, Neurology 2018
Slide 4: Annovis' new approach to attack AD and PD
4 Annovis ’ new approach to attack AD and PD Chronic and acute brain insults lead to high iron levels, resulting in overexpression of neurotoxic proteins, impaired axonal transport, inflammation and neurodegeneration. Attacking one neurotoxic protein results in minimal effect. Buntanetap inhibits th
Slide 5: Alzheimer's disease
Alzheimer’s disease
Slide 6: ITT population: ADAS-Cog11 and ADCS-CGIC
6 ITT population: ADAS - Cog11 and ADCS - CGIC #/* p<0.05 ## p<0.01 ### p<0.001 # compared to baseline * compared to placebo
Slide 7: Buntanetap improves cognition in patients with mild, not moderate, AD
7 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 selection.
Slide 8: Buntanetap improves cognition in APOE4 carriers and non-carriers
8 Buntanetap improves cognition in APOE4 carriers and non - carriers AD frequency reaches 91% in homo - and 47% in heterozygous ApoE4 carriers . ApoE4 carriers (+/ - & +/+): 66.5% in pTau217/t - Tau>4.2% population vs 22.6% in pTau217/t - Tau<4.2% population # comparing to baseline # p<0.05 ## p<0.0
Slide 9: Buntanetap improves cognition in patients not on AChEIs and on AChEIs
9 Buntanetap improves cognition in patients not on AChEIs and on AChEIs # comparing to baseline * comparing to placebo */# p<0.05 **/## p<0.01 ***/### p<0.001
Slide 10: Forest plot shows consistency and robustness of efficacy
10 Forest plot shows consistency and robustness of efficacy Per. slow of decline (%)Adjusted Mean DiffNo. patients (Bun 30 mg,Placebo)Subgroup Overall Age >=65 Apolipoprotein E4 Negative Positive Ethnicity Hispanic Or Latino Not Hispanic Or Latino Gender Female Male Race Black White 27, 24 25, 23 9,
Slide 11: Buntanetap is safe in APOE4 carriers and non-carriers in ITT AD population
11 Buntanetap is safe in APOE4 carriers and non - carriers in ITT AD population All Doses 30mg Buntanetap 15mg Buntanetap 7.5mg Buntanetap Placebo 121 38 38 45 38 APOE Carriers (N=159) 51 (42%) 12 (31.6%) 17 (44.7%) 22 (48.9%) 13 (34.2%) # TEAEs 17 (14%) 3 (7.9%) 6 (15.8%) 8 (17.8%) 1 (2.6%) # TEAEs
Slide 12: FDA cleared AD development path to NDA
12 FDA cleared AD development p ath NDA Mild to moderate AD - 3 m Disease - modifying - 18 m Open Label We are here NDA Symptomatic - 6 m
Slide 13: FDA-cleared Phase 3 study in early Alzheimer's disease
13 FDA - cleared Phase 3 study: 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=375 N=375 N=750 Key inclusion c riteria : • Diagnosis AD ac
Slide 14: Path forward – Alzheimer's disease
14 Path forward – Alzheimer’s disease 1. Buntanetap shows promising efficacy in early AD patients . 2 . FDA EOP2 meeting: • G ranted clearance to proceed with a pivotal Phase 3 study. • Aligned on development pathway with new crystal formulation. (one 6/18 - month trial) • S ubgroup analyses provide
Slide 15: Thanks to all clinical trial participants and their families
15 Thanks to all clinical trials participants and their families Annovis team: Maria Maccecchini Mike Christie Eve Damiano Cheng Fang Melissa Gaines Sarah MacCallum Andrew Walsh Blake Jensen Alexander Morin Hilda Maibach Maggie Wyatt Advisors: Marty Farlow Danny Laskowitz John Bennett Jeff Cummings
Slide 16: Parkinson's disease
Parkinson’s disease
Slide 17: ITT population, cognitive impairment: MMSE and dementia stage
17 ITT population, cognitive impairment: MMSE and dementia stage *p<0.05
Slide 18: ITT population: MDS-UPDRS II and III
18 ITT population: MDS - UPDRS II and III
Slide 19: Per protocol population: MDS-UPDRS II, III, IV, total and MMSE
19 Per protocol population: MDS - UPDRS II, III, IV, total and MMSE -0.5 0.0 0.5 1.0 1.5 MDS-UPDRS Part II (N=367) D i f f e r e n c e b e t w e e n E O T a n d B a s e l i n e Placebo 10mg 20mg -5 -4 -3 -2 -1 0 1 MDS-UPDRS Part III (N=367) D i f f e r e n c e b e t w e e n E O T a n d B a s e l i n
Slide 20: Buntanetap is safe in ITT PD population
20 Buntanetap is safe in ITT PD population All Doses 20mg Buntanetap 10 mg Buntanetap Placebo 774 173 174 176 297 (56.8%) 108 (62.4%) 98 (56.3%) 91 (51.7%) # Subjects with any AEs 287 (54.9%) 105 (60.7%) 96 (55.2%) 86 (48.9%) # Subjects with TEAEs 20 (3.8%) 11 (6.4%) 4 (2.3% ) 5 (2.8%) # Subjects wi
Slide 21: Key learning and path forward – Parkinson's disease
21 Key learning and path forward – Parkinson’s disease 1. Buntanetap prevents worsening of cognition in ITT population - all treated patients. 2. Buntanetap improves cognitive function in patients with impaired cognition. 3. In per protocol population, buntanetap significantly improves MDS - UPDRS P
Slide 22: Financing of Annovis through two 6/18-month pivotal studies
23 Financing of Annovis through two 6/18 - month pivotal studies ELOC: Equity L ine of Credit ATM: At the Market Offering $12 Million Cash on Hand • Maintained this level since June while completing preparatory work for the pivotal Phase 3 AD study. $50 Million ATM Facility Secured • Recently closed
Slide 23: Thank you, Questions?
ANNOVIS THANK YOU QUESTIONS?