Inhibikase Therapeutics, Inc. · NASDAQ:IKT
Inhibikase Therapeutics — Investor Presentation (August 2022)
29 slides from Inhibikase Therapeutics's investor presentation, Aug 15, 2022
Slide 1: 3Q 2022 Business Presentation
Exhibit 99.1 3Q 2022 | BUSINESS PRESENTATION Clinical Development of Disease-Modifying Therapeutics for Neurodegenerative Disease & Cancer Inhibikase.com : IKT
Slide 2: Disclaimer
DISCLAIMER This presentation shall not constitute an offer to sell or a solicitation of an offer to buy any securities, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification unde
Slide 3: Multi-Therapeutic Pipeline of Kinase Inhibitor Therapeutics
MULTI-THERAPEUTIC PIPELINE OF KINASE INHIBITOR THERAPEUTICS Developing innovative medicines across the therapeutic spectrum • Focused on developing novel therapeutics across a wide therapeutic spectrum including neurodegeneration, oncology and infectious diseases. • Aim to discover novel therapeutic
Slide 4: Company Highlights: Multi-Therapeutic Pipeline
COMPANY HIGHLIGHTS: MULTI-THERAPEUTIC PIPELINE Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease (1). ‘Clinical Development’ progress 1 3 bars represent the current state of the CLINICAL DEVELOPMENT BIOMARKER indicated programs. Blue arrows represent completed or in pro
Slide 5: Parkinson's Disease Market & Strategy
Parkinson’s Disease Market & Parkinson’s Disease Market & Strategy Strategy Inhibikase.com • : IKT 5
Slide 6: The Market: Large Market, Opportunity for Disease Modification
THE MARKET 1 Large Market, Opportunity For Disease Modification Parkinson’s Disease in the U.S. By 2025, Parkinson’s disease Chronic Disease for a Long Time 930,000 – 1,200,000 drug sales are expected to 1 1/3 of a Patient’s Lifespan = 25 years U.S. Patients DOUBLE Pharma Insights, 2019 60,000 38,00
Slide 7: Common Features of Misfolded Protein Diseases
COMMON FEATURES OF MISFOLDED PROTEIN DISEASES Causation in Parkinson’s and Alzheimer’s is 1 closely related What role does the misfolded protein play? 1 Nat. Neurosci. 21: 1332-1340 (2018) Inhibikase.com • : IKT 7
Slide 8: Cause of Neurodegeneration
CAUSE OF NEURODEGENERATION Evaluation of the Misfolded Protein ‘Seed’ in Parkinson’s Reveals c-Abl as the Primary Culprit Play Video > Inhibikase.com • : IKT 8
Slide 9: How Inhibikase Will Modify Parkinson's Disease: c-Abl Kinase Inhibition
How Inhibikase Will Modify Parkinson’s Disease: C-Abl Kinase Inhibition with IkT-148009 Inhibikase.com • : IKT 9
Slide 10: A Medicinal Chemistry Approach That Builds on Existing Knowledge
A MEDICINAL CHEMISTRY APPROACH THAT BUILDS ON EXISTING KNOWLEDGE TM Discovery using a Re-engineering Approach with Metabolism Preserved (RAMP ) Inhibikase.com • : IKT 10
Slide 11: IkT-148009 is a Small Molecule c-Abl Inhibitor
IS A SMALL MOLECULE c-ABL INHIBITOR IkT-148009 is Low Toxicity, Selective, Brain Penetrant 1 c-Abl Inhibitor in Clinical Development TOXICOLOGY IN RAT/MONKEY Human equivalent dose of 1460 mg Imatinib Dasatinib Nilotinib IkT-148009 Cardiovascular None 120 Renal None Liver None 100 Bone marrow None •
Slide 12: Modifies Parkinson's Disease
MODIFIES PARKINSON'S DISEASE c-Abl inhibition by IkT-148009 blocks the four pillars of Parkinson’s disease 1 in Validated Animal Models a -Synuclein Toxicity Neurodegeneration Motor Dysfunction Neuroinflammation clears preserves restores suppresses to baseline in the as much as 85% as much as 90% to
Slide 13: Clinical Development of IkT-148009
Clinical Development of IkT-148009 Inhibikase.com • : IKT 13
Slide 14: Phase 1/1b: Dose Proportional Pharmacokinetics & No Significant Adverse Events
PHASE 1 TRIAL IN SAFETY AND DOSING PHASE 1/1B: Dose Proportional Clinical Pharmacokinetics & No Clinically Significant Adverse Events Healthy Subjects Value Parkinson Patient Value Category Demographic (% of Total N=88) (% of Total, N=13) Gender Female 34 (38.6) 6 (42.8) Male 54 (61.4) 7 (57.2) Age
Slide 15: Phase 1: Dose Proportional Pharmacokinetics & No Significant Adverse Events
PHASE 1 TRIAL IN SAFETY AND DOSING PHASE 1: Dose Proportional Clinical Pharmacokinetics & No Clinically Significant Adverse Events Clinical Pharmacokinetics of IkT-148009-SAD Cmax AUC Linear (Cmax) Linear (AUC) 200000 R² = 0.9977 6000 180000 R² = 0.9905 160000 SIGNIFICANCE OF 5000 140000 CLINICAL 40
Slide 16: Phase 1b Trial to Evaluate Safety in Parkinson's Patients
PHASE 1B TRIAL TO EVALUATE SAFETY IN PARKINSON'S PATIENTS PHASE 1B: § Pharmacokinetics in patients similar to elderly healthy subjects with similar T and 1/2 exposures (both C and AUC ). max 0-inf § PD assessments do not demonstrate a worsening of disease Inhibikase.com • : IKT 16
Slide 17: Ongoing Trials: Clinical Phase 2 '201' Trial
ONGOING TRIALS IN SAFETY AND DOSING CLINICAL PHASE 2: the ‘201’ Trial JUNE, 2022 u 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 PHASE 2a (Up to 12 months) PHASE 2A ‘201’ TRIAL / 3 Months Dosing Across 3 Doses • Secondary endpoints UPDRS II, III, II+III, PGI-S, CGI-S, • 3 dosing cohorts, 1 placebo co
Slide 18: Stable-Phase Chronic Myelogenous Leukemia Market and Strategy
Stable-Phase Chronic Myelogenous Leukemia Market and Strategy Inhibikase.com • : IKT 18
Slide 19: The Market: Accessible Market Opportunity Despite Presence of Generic
THE MARKET 1 Accessible Market Opportunity Despite Presence of Generic CML in the U.S. Prevalence of Chronic Myeloid Leukemia in the U.S. • Patients commonly switch due to intolerance or 3 lack of response ® • Intolerance to Gleevec occurs in 30% of patients, leading to lack of treatment 4 complianc
Slide 20: IkT-001Pro Strategy
IkT- 001Pro STRATEGY IkT-001Pro releases the active ingredient imatinib only in blood 4-carbon atom linker imatinib linker gut wall + pH 2-6 pH 7 (blood) (stomach, ileum, duodenum) Lifetime in blood < 10 min Inhibikase.com • : IKT 20
Slide 21: IkT-001Pro is a Small Molecule BCR-Abl Inhibitor
IkT- 001Pro IS A SMALL MOLECULE BCR-Abl INHIBITOR IkT-001Pro: ® Lower GI Toxicity Alternative to Generic Gleevec Measurement of IkT-001Pro in Non-Human Primates RESULTS SUGGEST THAT: No Adverse Event Level Cmax Tmax AUC 0-T (mg/kg) ü Achieve dose flexibility, (mean, ng/mL) (mean, h) (mean, ng-h/mL)
Slide 22: Trials in Bioequivalence and Superiority: Clinical Development of IkT-001Pro
TRIALS IN BIOEQUIVALENCE AND SUPERIORITY Clinical Development of IkT-001Pro JUNE, 2022 u 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Bioequivalence IkT- 001Pro (Up to 3 months) Single dose two-part trial to bioequivalence • Part 1: 3 dosing cohorts, 10 subjects each to find dose equivalent to 400 m
Slide 23: Selected Stock and Financial Data
Selected Stock and Financial Data In Inh hiib biik ka as se e.c .co om m • • :: IK IKT T 23 23
Slide 24: Company Highlights: Selected Financial and Stock Data
COMPANY HIGHLIGHTS Selected Financial and Stock Data Capitalization Table June 30, 2022 June 30, 2022 Balance Sheet (last reporting period) Common Shares Outstanding 25,227,051 Current Assets: Options (WAEP: $2.25) 4,238,056 Cash $32,212,276 Warrants (WAEP: $5.21) 1,561,913 Grants Receivable $6,552
Slide 25: Company Highlights: Upcoming Milestones
COMPANY HIGHLIGHTS Upcoming Milestones: 3Q 2022 IkT-001Pro • First randomized patient in IkT-148009 Phase 2a study • Commence bioequivalence clinical study following in treatment naive Parkinson’s patients FDA review of the IND or receipt of Study May Proceed • Design PK bridging study to evaluate p
Slide 26: About Us / Executives
ABOUT US / EXECUTIVES Management Team with Deep Experience in Drug Development and Commercialization Milton Werner, PhD Joseph Frattaroli, CPA C. Warren Olanow, MD, President & CEO Chief Financial Officer Interim Chief Medical Officer and Chief Executive Officer of CLINTREX. Previously, Dr. Werner s
Slide 27: About Us / Board of Directors
ABOUT US / BOARD OF DIRECTORS Mr. Dennis Berman Dr. Roy Freeman, MD Dr. Paul Grint, MD Ms. Elizabeth O’Farrell • Co-founder, board member, and/or • Professor of Neurology at the Harvard • 20+ years experience in biologics and • 25-year career with Eli Lilly and seed investor in many private Medical
Slide 28: About Us / Industry-Leading Advisors
ABOUT US / INDUSTRY-LEADING ADVISORS Dr. Valina Dawson, PhD Dr. Karl Kieburtz, MD, MPH Robert Hauser, MD Neurodegeneration and Stem Cell Programs, Institute for Cell Robert J. Joynt Professor in Neurology, Senior Associate Dean for Professor of Neurology, University of Engineering, Departments of Ne
Slide 29: Contact
CONTACT E: info@inhibikase.com PH: 678-392-3419 GEORGIA OFFICE 3350 Riverwood Parkway Suite 1900 Atlanta, GA 30339 MASSACHUSETTS OFFICE 1 Cranberry Hill Suite 200 Lexington, MA 02421 Inhibikase.com : IKT
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