Inhibikase Therapeutics, Inc. · NASDAQ:IKT
Inhibikase Therapeutics — Investor Presentation (June 2021)
30 slides from Inhibikase Therapeutics's investor presentation, Jun 1, 2021
Slide 1: 2Q 2021 Business Presentation
Exhibit 99.1 IKT Clinical Development of Therapies Intended to Reverse the Functional Loss in Parkinson’s and Related Disorders 2Q 2021 BUSINESS PRESENTATIONExhibit 99.1 IKT Clinical Development of Therapies Intended to Reverse the Functional Loss in Parkinson’s and Related Disorders 2Q 2021 BUSINES
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: Company Overview
IKT Company OverviewIKT Company Overview
Slide 4: Company Highlights: Driving Functional Reversal of Parkinson's Disease
COMPANY HIGHLIGHTS Driving Functional Reversal of Parkinson’s Disease BY 2025, PARKINSON’S DISEASE § Multi-therapeutic pipeline with emphasis on neurodegeneration inside and out DRUG SALES ARE EXPECTED TO side of the brain § Our lead inhibitor of the Abelson Tyrosine Kinase (c-Abl), IkT-148009, halt
Slide 5: Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease
COMPANY HIGHLIGHTS: MULTI-THERAPEUTIC PIPELINE Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease 5COMPANY HIGHLIGHTS: MULTI-THERAPEUTIC PIPELINE Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease 5
Slide 6: Selected Financial and Stock Data
COMPANY HIGHLIGHTS Selected Financial and Stock Data § $20.4M non-dilutive grant revenue pre-IPO (NIH, DoD, States) § $19M equity sales since 2018, $18M from Initial Public Offering with ThinkEquity § 10,133,345 issued and outstanding common shares as of 5/14/2021 § 3,574,658 Options (WAEP $2.43) §
Slide 7: Accelerated Clinical Development Timeline
ONGOING TRIALS IN SAFETY AND DOSING Accelerated Clinical Development Timeline Pre-IPO plan, Dec. 2020 Sequential Single Ascending Dose (SAD) in 8 cohorts, followed by Multiple Ascending Dose (MAD) in 4 cohorts PD patients in late 4Q21 or 1Q22 Phase 1b (Overlapping, Up to 6 Months) Phase 1 SAD / MAD
Slide 8: Parkinson's Disease Market & Strategy
IKT Parkinson’s Disease Market & Strategy IKT Parkinson’s Disease Market & Strategy
Slide 9: Parkinson's Disease in the U.S.
THE MARKET 1 Parkinson’s Disease in the U.S. Large Market, Opportunity For Disease Modification Chronic Disease for a Long Time 700,000 – 1,000,000 1/3 of a Patient’s Lifespan = 25 years U.S. Patients 60,000 38,000 60 DEATHS / YEAR NEW CASES / YR AVERAGE AGE OF ONSET Other illnesses complicate devel
Slide 10: How the GI Tract Illuminates a Novel Way to Treat Patients
HOW THE GI TRACT ILLUMINATES A NOVEL WAY TO TREAT PATIENTS Model studies suggest the gut could be where Parkinson’s disease originates in the body and is a critical organ for analysis The Gut-Brain Connection Enables Innovation in Trial Design Parkinson’s May Begin in the Gut Easy access Can demonst
Slide 11: Causation of Parkinson's and How Inhibikase Proposes to Modify Disease
IKT Causation of Parkinson’s and How Inhibikase Proposes to Modify DiseaseIKT Causation of Parkinson’s and How Inhibikase Proposes to Modify Disease
Slide 12: Investigating Causation in Parkinson's Reveals c-Abl as a Primary Culprit
NEURODEGENERATION Investigating Causation in Parkinson’s Reveals c- Abl as a Primary Culprit § Parkinson’s Disease (PD) is a neurodegenerative disease which limits function of nerve cells throughout the brain and gut. § PD conditions include: Tremors Slowed Movement Impaired Balance Permanent Consti
Slide 13: The Path to Neurodegeneration
CE L L E N T R Y THE PATH TO NEURODEGENERATION Stressors Trigger the Production of α-Synuclein Plaques Which Activates c-Abl to Drive Neurodegeneration 1 The Effects and Stressors Trigger α-Synuclein Forms C-Abl is a Sentinel which Patrols for NEURODEGENERATION Results of Activated Abnormalities the
Slide 14: Activated c-Abl Is the Gateway in the Disease Path
INHIBIKASE’S PROOF ACTIVATED C-ABL IS THE GATEWAY IN THE DISEASE PATH α-Synuclein Plaques Do Not Cause Disease Without c-Abl 1 Modification in Humanized Preclinical Models α-Synuclein plaque in the ABSENCE OF c-Abl CAUSES NO NEURODEGENERATION AFTER 6 MONTHS No c-Abl = No neurodegeneration Injection
Slide 15: Pathologic c-Abl-Modified α-Synuclein Present in Parkinson's Patient Brain
STUDY Pathologic, c-Abl-Modified α-Synuclein (pY39) is Present in 1 Parkinson’s Patient Brain Toxic pY39-a-Synuclein Toxic pY39-a-Synuclein Abundant Prominent in Lewy Bodies In Substantia Nigra (SN) of Patients 1 J Clin Invest. 126, 2970-88 (2016) 15STUDY Pathologic, c-Abl-Modified α-Synuclein (pY39
Slide 16: Low Toxicity, Brain Penetrant c-Abl Inhibitor in Clinical Development
ONGOING TRIALS IN SAFETY AND DOSING\ Low Toxicity, Brain Penetrant c-Abl Inhibitor in Clinical Development 1 14-Day Toxicology in Rat/Monkey NOVEL ABL KINASE RELATIVE INHIBITOR POTENCY Human equivalent dose of 600 mg Cardiovascular None § No observed toxicity from off target 148019 8 Renal None kina
Slide 17: Dose Proportional Clinical Pharmacokinetics and Favorable Adverse Event Profile
ONGOING TRIALS IN SAFETY AND DOSING Dose Proportional Clinical Pharmacokinetics and Favorable Adverse Event Profile Clinical Pharmacokinetics of IkT-148009-SAD Cmax AUC Linear (Cmax) Linear (AUC) 5000 70000 4500 R² = 0.9925 60000 4000 50000 3500 3000 40000 2500 R² = 0.9995 30000 2000 1500 20000 1000
Slide 18: Low Oral Dose in Humans Reaches Therapeutic Exposures of Animal Models
ONGOING TRIALS IN SAFETY AND DOSING Low Oral Dose in Humans Reaches The Therapeutic Exposures of Animal Models Clinical Pharmacokinetics IkT-148009 compared to therapeutic dose in animal models of progressive disease t t C AUC 1/2 max max 0- ∞ mg/day (h) (h) (ng/mL) (h*ng/mL) 1 IkT-148009 Mean 25 25
Slide 19: Updated Phases and Development Intervals for 2021
ONGOING TRIALS IN SAFETY AND DOSING Updated Phases and Development Intervals for 2021 Single Ascending Dose (SAD) § 8 dosing cohorts (25 – 400 mg, 1x/day) § 8 patients/cohort, 2:1 randomized § Sentinel dosing § Primary objectives safety, tolerability , pharmacokinetics (PK), urine and plasma concent
Slide 20: Proof of Functional Reversal in the Brain and Gut in Animal Models
IKT Proof of Functional Reversal in the Brain and Gut in Animal Models of DiseaseIKT Proof of Functional Reversal in the Brain and Gut in Animal Models of Disease
Slide 21: Oral IkT-148009 in Mice Reverses Functional Loss
ANIMAL STUDY BASIS OF IkT-148009 THERAPY Oral IkT-148009 in Mice Humanized for Parkinson’s Disease in Brain Reverses Functional Loss Baseline Neuromuscular Toxic Levels of Synuclein Are Treatment Started 6 Weeks After Onset of Near Normal Behavior Returned Following Introduced Into One Side of the C
Slide 22: Oral IkT-148009 Suppresses c-Abl Activation in the Brain
ANIMAL STUDY BASIS OF 148009 THERAPY Oral IkT-148009 Suppresses c-Abl Activation in the Brain that Correlates with Functional Recovery IkT-148009 engages the c-Abl target in the brain Activated c-Abl in disease Baseline Inhibition of c-Abl below baseline by IkT-148009 22 Normal Mice Normal Mice +148
Slide 23: Oral IkT-148009 Preserves Neural Anatomy in the Brain
ANIMAL STUDY BASIS OF 148009 THERAPY Oral IkT-148009 Preserves Neural Anatomy in the Brain IkT-148009 stopped loss of neurons, accounting for functional recovery Placebo IkT-148009 only, no disease A53T induced disease A53T-induced disease + IkT-148009 Normal # neurons Rescued # neurons (≥ 80%) Dise
Slide 24: Evidence of Functional Recovery in the Gut
EVIDENCE OF FUNCTIONAL RECOVERY IN THE GUT Oral IkT-148009 in Mice Humanized for Parkinson’s Disease in Gut Reverses Functional Loss METHOD OF MEASUREMENT POST TREATMENT RESULTS α-Synuclein Aggregates Introduced Into At 3 months defecation slows to 500 min (3x normal); At 6 months Gut Slows Gut Tran
Slide 25: Proof of Toxicity Clearance in the Brain and Gut in Animal Models
IKT Proof of Toxicity Clearance in the Brain and Gut in Animal Models of DiseaseIKT Proof of Toxicity Clearance in the Brain and Gut in Animal Models of Disease
Slide 26: Oral IkT-148009 Treatment Clears Toxic α-Synuclein
EFFECT ON CAUSE OF DISEASE Oral IkT-148009 Treatment Clears Toxic a-Synuclein in the brain and gut Clearance of toxicity in the gut Clearance of toxicity in the brain Green: Pathological a-synuclein Red: Neural ganglia in gut Aggregates Cleared during treatment with IkT- 148009 IkT-148009 drives cle
Slide 27: Research Advances Are Transformational
RESEARCH ADVANCES ARE TRANSFORMATIONAL Advances in pre-clinical models and clinical dosing § IKT-148009 drives functional recovery inside and outside of the brain § IKT-148009 drives clearance of the toxic form of a- synuclein § Low oral doses in humans achieve therapeutic exposure levels observed i
Slide 28: Upcoming Milestones
COMPANY HIGHLIGHTS Upcoming Milestones IkT-148009 Five clinical programs by close of 2021 Completion of Phase 1 Healthy Volunteer Study SAD/MAD 3Q21 Anticipated dosing of Parkinson’s patients by early 3Q21 Completion of chronic toxicology studies 4Q21 IkT-001Pro IND filing 3Q221 Bioequivalence study
Slide 29: Management Team with Deep Experience in Drug Development
ABOUT US Management Team with Deep Experience in Drug Development and Commercialization Executive MiltonWerner,PhDPresident&CEO Previously, Dr. Werner served as Director of Research at Celtaxsys. From September 1996 until June 2007, Dr. Werner was a Head of the Laboratory of Molecular Biophysics at
Slide 30: Board of Directors and Industry-Leading Advisors
Board Industry-Leading of Directors Advisors Mr. Dennis Berman has been a co-founder, board member, Dr. Roy Freeman, MD is Professor of Neurology at the Robert Hauser, MD and/or seed investor in many private biotechnology and Professor of Neurology, University of South Florida Harvard Medical School
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