Annovis Bio, Inc. · NYSE:ANVS
Annovis Bio — Investor Presentation (March 2021)
26 slides from Annovis Bio's investor presentation, Mar 23, 2021
Slide 1: Attacks Alzheimer's Disease and Neurodegeneration by Improving Axonal Transport
Attacks Alzheimer’s Disease and Neurodegeneration by Improving the Information Highway of the Nerve Cell Axonal Transport March 2021 Symbol: ANVS (NYSE American)
Slide 2: Forward-Looking Statements
FORWARD - LOOKING STATEMENTS Statements in this presentation contain “forward - looking statements” that are subject to substantial risks and uncertainties. Forward - looking statements contained in this presentation may be identified by the use of words such as “anticipate,” “expect,” “believe,” “w
Slide 3: Highlights
3 ▪ Annovis is developing drugs for Alzheimer's (AD) and Parkinson's disease (PD), including the orphan indication Alzheimer's in Down Syndrome (AD - DS) ▪ Lead compound, ANVS401, is the only drug to improve axonal transport, the information highway of the nerve cell, by attacking multiple neurotoxi
Slide 4: The State of Neurodegenerative Diseases
THE STATE OF NEURODEGENERATIVE DISEASES ▪ 5.8 million people in the US and 44 million people worldwide are estimated to suffer from AD ▪ PD affects an estimated one million people in the U.S. and as many as 10 million globally ▪ Total costs of care for people with Alzheimer’s and other dementias cou
Slide 5: Change in Causes of Death from 2000 to 2018
CHANGE IN CAUSES OF DEATH FROM 2000 TO 2018 5 • Breast Cancer - 13% • Colon Cancer - 21% • Heart Disease - 21% • Stroke - 24% • HIV - 67% • Parkinson’s + 84% • Alzheimer’s + 112%
Slide 6: Annovis' Drug Attacks Multiple Neurotoxic Proteins
Chronic and acute brain insults lead to high levels of neurotoxic proteins, to inflammation and neurodegeneration Attacking one neurotoxic protein results in minimal effect ANVS401 is the only drug to attack multiple neurotoxic proteins simultaneously Amyloid β AD / PD - A β Targeting Compounds ANNO
Slide 7: Pipeline
PIPELINE 7 Therapy Diseases/Conditions PRE - CLINICAL IND PHASE I PHASE II PHASE III AD PD AD - DS FTD CTE TBI Stroke Advanced AD Oral drug for chronic indications Injectable drug for acute traumatic events Oral drug for advanced AD and dementia
Slide 8: Corporate Patent Estate
8 CORPORATE PATENT ESTATE Patent/Application Subject Matter Status Expiry Provisional ANVS401 to treat viral and bacterial infections of the brain, including Covid19 Pending 2041 PCT ANVS401 and 405 – Mechanism of Action for prevention and treatment of diseases Pending 2038 PCT ANVS405 - Acute brain
Slide 9: How Nerve Cells Work
NEUROTRANSITTERS THAT TRAVEL ACCROSS THE AXON Adrenaline Noradrenaline Dopamine HOW NERVE CELLS WORK In healthy nerve cells little packages containing neurotransmitters or nerve growth factors travel unimpaired from the cell body through the axon to the synapse. SOMA & CELL BODY DENDRITES Serotonin
Slide 10: Neurotoxic Proteins Impair Axonal Transport and Cause a Toxic Cascade
NEUROTOXIC PROTEINS IMPAIR AXONAL TRANSPORT AND CAUSE A TOXIC CASCADE ANVS401 IMPROVES AXONAL TRANSPORT AND IMPEDES THE TOXIC CASCADE IMPAIRED AXONAL TRANSPORT SLOWER SYNAPTIC TRANSMISSION INFLAMMATION DEATH OF NERVE CELLS LOSS OF COGNITIVE AND MOTOR FUNCTION IMPROVED AXONAL TRANSPORT INCREASED SYNA
Slide 11: Results in Humans
11 RESULTS IN HUMANS ANVS401 Lowers Neurotoxic Proteins in Cerebrospinal Fluid (CSF) of Mild Cognitive Impaired (MCI) Patients ▪ In this proof - of - concept study, ANVS401 lowers the levels of APP/Aβ, tau/p - tau and αSYN back to the levels seen in healthy volunteers ▪ It lowers the levels of the t
Slide 12: 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 13: ANVS401 Lowers Inflammatory Markers
13 ANVS401 LOWERS INFLAMMATORY MARKERS Maccecchini et al: JNNP 2012; 83: 894 - 902 CSF Inflammatory Markers Significantly Decrease After 10 Days of Oral ANVS401 in MCI Patients Inflammatory Protein CSF % of Baseline p - Value Complement C3 - 86.9% 0.0007 MCP - 1 - 87.5% 0.0007 YKL40 - 72.7% 0.0113 s
Slide 14: Results in Animals
14 RESULTS IN ANIMALS Multiple animal studies showed that ANVS401 improved the affected function Function Animal Model Memory and learning AD mice, DS mice, stroke mice, TBI rats Movement PD mice, FTD mice Eyesight Acute glaucoma rats
Slide 15: Two Phase 2 Clinical Trials
15 TWO PHASE 2 CLINICAL TRIALS AD Trial AD / PD Trial CRO ADCS Parexel Therapeutic Area Early AD Early to Moderate AD and PD Phase 2 2 Patients 24 28 + 40 Sites 6 12 Country United States Design Double - Blind, Placebo - Controlled, Biomarker Study Endpoints Reversal of Toxic Cascade
Slide 16: Phase 2 Clinical Trial in AD and PD to Measure Reversal of Toxic Cascade
PHASE 2 CLINICAL TRIAL IN AD AND PD TO MEASURE REVERSAL OF THE TOXIC CASCADE AND IMPROVEMENT IN BRAIN FUNCTION DECREASE IN NEUROTOXIC PROTEINS INCREASE IN NEUROTRANSMITTERS LOWERING OF INFLAMMATORY PROTEINS LOWERING OF NEURODEGENERATION MARKERS COGNITION AND MOTOR FUNCTION ENDPOINTS TARGET: PATHWAY:
Slide 17: Timeline of Phase 2 Clinical Trial in AD and PD
TIMELINE OF PHASE 2 CLINICAL TRIAL IN AD and PD Preliminary data to be available beginning in 1Q2021 Start Up AD/PD Study August 2020 May 2021 June 2021 17 A meeting with the FDA to discuss the data from the AD and the PD study as well as from the chronic toxicology in rats and dogs is projected for
Slide 18: Efficacy in PD Patients – Speed & Coordination
EFFICACY IN PD PATIENTS – SPEED & COORDINATION Preliminary data from first 14 PD patients 30 35 40 45 50 55 0 25 BASELINE VS 25 DAYS 30 35 40 45 50 55 PLACEBO ANVS401 PLACEBO VS 401 0 0.5 1 1.5 2 2.5 3 0 25 Baseline vs 25 Days 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 placebo ANVS401 Placebo vs 401 Speed: Left
Slide 19: Reversal of Toxic Cascade
REVERSAL OF TOXIC CASCADE EXPECTED OUTCOME ACTUAL OUTCOME Level of neurotoxic proteins Axonal transport Inflammation Dead nerve cells Control proteins 0 Efficacy: Motor function + Efficacy: Cognition REVERSAL OF TOXIC CASCADE Preliminary data from first 14 PD patients 19 +++ p < 0.001 0 no change ++
Slide 20: Market Projections
1% 2% 4% 8% 16% 47% 60-65 65-70 70-75 75-80 80-85 85+ 20 MARKET PROJECTIONS Source: Alzheimer‘s Association 2014; Incidence of AD in Relation to Age Increase in Incidence with Aging of Population Annual sales potential for US and worldwide are over $100 billion dollars
Slide 21: Financial Highlights
FINANCIAL HIGHLIGHTS 21 ▪ Completed IPO in January 2020 ▪ Cash balance provides runway to end of 2021 ▪ NIH grants funding ADCS Phase 2a trial in AD and chronic toxicology study ▪ ~40% insider ownership ▪ Analyst coverage from ThinkEquity and Maxim Group Ticker NYSE American: ANVS Recent Price $25.5
Slide 22: Chief Executives and Chief Advisors
CHIEF EXECUTIVES AND CHIEF ADVISORS Jeffrey Cummings, MD, Chief Medical Advisor Dr . Cummings completed Neurology residency and a Fellowship in Behavioral Neurology at Boston University, Boston, Massachusetts . US training was followed by a Research Fellowship in Neuropathology and Neuropsychiatry a
Slide 23: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD 23 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 circula
Slide 24: Board of Directors
24 Michael B . Hoffman Chairman Mr . Hoffman is the Founder and Managing Partner of Stone Capital Partners, a private equity firm focused on power and renewable energy . He was Partner of Riverstone, senior managing director at the Blackstone Group and managing director at Smith Barney, Harris Upham
Slide 25: Investment Summary
INVESTMENT SUMMARY A novel approach to treat neurodegeneration is desperately needed ▪ The markets for AD and PD drugs are in the multibillions of dollars and growing ▪ Annovis has a novel approach to stop the course of AD and PD ▪ ANVS401 improves axonal transport and recovers the affected function
Slide 26: 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 Dave Gentry CEO, RedChip Companies +1 (407) 491 - 4498 dave@redchip.com www.annovisbio.com Symbol: