Annovis Bio, Inc. · NYSE:ANVS
Annovis Bio — Investor Presentation (February 2023)
28 slides from Annovis Bio's investor presentation, Feb 13, 2023
Slide 1: Attacks Neurodegeneration, Alzheimer's and Parkinson's Diseases
Attacks Neurodegeneration, Alzheimer’s and Parkinson’s Diseases by Improving the Information Highway of the Nerve Cell February 2023 Symbol: ANVS (NYSE) - People Focused, Purpose Driven, Passion Powered -
Slide 2: Forward Looking Statements and Other Important Cautions
FORWARD-LOOKING STATEMENTS Forward Looking Statements and Other Important Cautions -- This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to all information other than historical mat
Slide 3: Company Highlights
3 Therapeutic focus/approach: treatment of Alzheimer’s disease (AD) and Parkinson's disease (PD) as neurodegenerative, axonal transport diseases Buntanetap (lead asset): only drug to improve cognition in AD AND motor function in PD patients Unique MoA: restores health of nerve cells and improves fun
Slide 4: Investment Highlights
4 INVESTMENT HIGHLIGHTS Targeting growing indications ▪ Parkinson’s Disease – 1.2 million patients in US ▪ Alzheimer’s Disease – 6 million patients in US Multiple Catalysts Key clinical and regulatory milestones ▪ PD – phase 3, interim data expected Q2 2023 ▪ AD – first patient dosed in phase 2/3 tr
Slide 5: Pipeline
PIPELINE Therapy Diseases/Conditions | PRE-CLINICAL IND PHASE | PHASE II PHASE Ill Alzheimer's disease (AD) B t t Parkinson's disease (PD) untane ap Lewy body dementia (LBD) Oral drug for chronic indications Others ANWR 405 i Injectable drug for acute Stroke traumatic events ANVS301 Oral drug for ad
Slide 6: Neurotoxic Proteins Impair Axonal Transport and Cause a Toxic Cascade
NEUROTOXIC PROTEINS IMPAIR AXONAL TRANSPORT AND CAUSE A TOXIC CASCADE IMPAIRED AXONAL TRANSPORT SLOWER SYNAPTIC TRANSMISSION INFLAMMATION DEATH OF NERVE CELLS LOSS OF COGNITIVE AND MOTOR FUNCTION HIGH LEVELS OF NEUROTOXIC PROTEINS
Slide 7: Annovis' New Approach to Attack AD and PD
Attacking one neurotoxic protein results in minimal effect Amyloid β Alzheimer’s - Parkinson’s ANNOVIS’ NEW APPROACH TO ATTACK AD AND PD Chronic and acute brain insults lead to high levels of neurotoxic proteins, impaired axonal transport, inflammation and neurodegeneration Tau Tauopathies - AD, PD,
Slide 8: Neurodegeneration Is an Axonal Transport Disease
NEURODEGENERATION IS AN AXONAL TRANSPORT DISEASE Axonal transport is responsible for: Normal Transport The Normal Flow and Speed of vesicles carrying BDNF across the axon. ▪ Neurotransmitters GABA (anxiety), ACh (cognition), dopamine (movement), serotonin (mood) ▪ Neurotrophic factors NGF, BDNF ▪ Al
Slide 9: Neurodegeneration Means Dead Nerve Cells
NEURODEGENERATION MEANS DEAD NERVE CELLS Buntanetap protects nerve cells from dying in the brain or traumatic brain injury rats And it protects nerve cells from dying in the eye in glaucoma rats 9 Hatami A. et al: Buntanetap improves dopaminergic neuropathology and working memory in a rat model of t
Slide 10: Buntanetap Improves Axonal Transport and Impedes the Toxic Cascade
BUNTANETAP IMPROVES AXONAL TRANSPORT AND IMPEDES THE TOXIC CASCADE IMPROVED AXONAL TRANSPORT INCREASED SYNAPTIC TRANSMISSION NO INFLAMMATION HEALTHY NERVE CELLS IMPROVED COGNITIVE AND MOTOR FUNCTION BY LOWERING LEVELS OF NEUROTOXIC PROTEINS
Slide 11: Studies in Eight Animal and Human Models
FUNCTION TEST SUBJECT ANIMALS Memory, learning Mazes AD mice, DS mice, stroke mice, TBI rats Movement Colonic motility, grip strength PD mice, tau mice Vision Sight Glaucoma rats Infections Cell death P. Gingivalis mice, Covid mice HUMANS Cognition, memory, learning ADAScog11 * Early AD patients Att
Slide 12: Buntanetap Phase 2a Positive Data in Parkinson's Disease
12 BUNTANETAP PHASE 2 POSITIVE DATA IN PARKINSON’S DISEASE SIGNIFICANT IMPROVEMENTS IN BOTH MOTOR FUNCTION AND CODING SPEED Fang et al: Buntanetap Proves Promising in Both Alzheimer’s and Parkinson’s Patients; J Prevention Alzheimer Disease 10-2022
Slide 13: Ongoing Phase 3 Clinical Trial in Early PD Patients
ONGOING PHASE 3 CLINICAL TRIAL IN EARLY PD PATIENTS Therapeutic Area Early PD Phase 3 Sites 50 US + 50 EU = 100 Patients 3 X 150 = 450 Dose 0 , 10 and 20 mg/day Start August 2022 Design Double-Blind, Placebo-Controlled Efficacy Endpoints MDS-UPDRS 2 and 3 Other Total UPDRS, PGIC, CGIS, WAIS, Biomark
Slide 14: Development of Buntanetap for Early and Advanced PD to NDA
DEVELOPMENT OF BUNTANETAP FOR EARLY AND ADVANCED PD TO NDA 14 6 months 6 months Early PD Patients Advanced PD Patients 2 months Interim Analysis (expected in 2Q’23) NDA Submission Long chronic study in early PD 18 months Symptomatic Study Disease-modifying Study
Slide 15: Buntanetap Phase 2a Positive Data in Alzheimer's Disease
15 BUNTANETAP PHASE 2 POSITIVE DATA IN ALZHEIMER’S DISEASE SIGNIFICANT IMPROVEMENTS IN BOTH COGNITIVE FUNCTION AND CODING SPEED Fang et al: Buntanetap Proves Promising in Both Alzheimer’s and Parkinson’s Patients; J Prevention Alzheimer Disease 10-2022
Slide 16: Planned Phase 2/3 Clinical Trial in AD Patients
PLANNED PHASE 2/3 CLINICAL TRIAL IN AD PATIENTS Therapeutic Area Moderate AD Phase 2/3 Sites 80 US Patients 4 X 80 = 320 Dose 0 , 7.5, 15 and 30 mg/day Start February 2023 Design Double-Blind, Placebo-Controlled Efficacy Endpoints ADAScog 11, ADCS-CGIC Other WAIS, Biomarkers 16
Slide 17: Clinical Development Plans for Alzheimer's Disease
CLINICAL DEVELOPMENT PLANS FOR ALZHEIMER’S DISEASE NDA Submission Symptomatic Study 17 Long chronic study in early AD Disease-modifying Study 18 months Moderate AD 3 months End of phase 2 study meeting with FDA to discuss full development for disease-modifying studies 6 weeks Interim Analysis (expec
Slide 18: Corporate Patent Estate
Patent/Application Subject Matter Status Expiry Provisional Combinations Pending 2043 Provisional Neuropsychiatric Indications Pending 2043 Provisional Other Diseases Pending 2042 PCT Brain infections Pending 2042 PCT Use of mechanism of action One patent granted 2038 PCT Acute neurodegenerative inj
Slide 19: Senior Management Team
SENIOR MANAGEMENT TEAM 19 Maria L. Maccecchini,PhD Founder, President & CEO Henry Hagopian, MBA Chief Financial Officer Cheng Fang, PhD SVP, Research & Development Eve Damiano, MS, RAC SVP, Regulatory Melissa Gaines, VP, Clinical Operations • Broad scientific knowledge and over a decade in neurodege
Slide 20: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD Sidney Strickland, PhD, Chairman Vice President and Dean for Educational Affairs and Research Professor, Patricia and John Rosenwald Laboratory of Neurobiology and Genetics at Rockefeller University. Dr. Strickland’s laboratory investigates how dysfunction of the circulator
Slide 21: Key Takeaways
Annovis has a novel approach to address AD and PD Buntanetap shows improvements in Phase 2a clinical trials: 21 KEY TAKEAWAYS The first double-blind, placebo-controlled study that shows improvements in AD patients as measured by ADAS-Cog and in PD patients as measured by UPDRS Cognition in AD patien
Slide 22: Contact Us
Improves THE FLOW of Axonal Transport in Alzheimer’s Disease and Neurodegeneration CONTACT US 1055 Westlakes Drive Suite 300 Berwyn, PA 19312 +1 (610) 727-3913 info@annovisbio.com Investor Relations: Chris Calabrese +1 (917) 680-5608 ccalabrese@lifesciadvisors.com Kevin Gardner +1 (617) 283-2856 kga
Slide 23: Appendix
ANNOVIS Appendix
Slide 24: Mechanism of Action
MECHANISM OF ACTION Buntanetap inhibits the translation of neurotoxic proteins 24 * MOA; Chen XQ et al. Pharmaceutics 09-2021 Iron and Neurodegeneration; Wong F. et al. Frontiers Aging Neuroscience; 03-2022
Slide 25: Mechanism of Action: Molecular Model
MECHANISM OF ACTION Molecular Model of how Buntanetap locks IRP1 in the mRNA Binding Position IRP1 Buntanetap Eric Baldwin, NCI IRE 25
Slide 26: Buntanetap Improves Axonal Transport and Impedes the Toxic Cascade
BUNTANETAP IMPROVES AXONAL TRANSPORT AND IMPEDES THE TOXIC CASCADE IMPROVED AXONAL TRANSPORT INCREASED SYNAPTIC TRANSMISSION NO INFLAMMATION HEALTHY NERVE CELLS IMPROVED COGNITIVE AND MOTOR FUNCTION BY LOWERING LEVELS OF NEUROTOXIC PROTEINS
Slide 27: IRE to IRP1 Binding Is Specific for mRNAs Coding for Neurotoxic Proteins
IRE to IRP1 BINDING IS SPECIFIC FOR mRNAs CODING FOR NEUROTOXIC PROTEINS Buntanetap binds specifically to the APP IRE, but not to the ferritin IRE Chen XQ et al, Pharmaceutics 2021, 13(12), 2109 APP IRE/IRP1/Buntanetap Kd 3.2 nM Ferritin IRE/IRP1/Buntanetap No Kd 27
Slide 28: Inhibits Microglia Activation in Rat Brain
INHIBITS MICROGLIA ACTIVATION IN RAT BRAIN UCLA, Marie-Francoise Chesselet and David Hovda’s lab 28