Inhibikase Therapeutics, Inc. · NASDAQ:IKT
Inhibikase Therapeutics — Investor Presentation (August 2021)
32 slides from Inhibikase Therapeutics's investor presentation, Aug 17, 2021
Slide 1: Clinical Development of Therapies Intended to Reverse the Functional Loss in Parkinson's and Related Disorders
Exhibit 99.1 IKT Clinical Development of Therapies Intended to Reverse the Functional Loss in Parkinson’s and Related Disorders 3Q 2021 BUSINESSPRESENTATIONExhibit 99.1 IKT Clinical Development of Therapies Intended to Reverse the Functional Loss in Parkinson’s and Related Disorders 3Q 2021 BUSINESS
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 Highlights: Driving Functional Reversal of Parkinson's Disease
COMPANY HIGHLIGHTS Driving Functional Reversal of Parkinson’s Disease BY 2025, PARKINSON’S § Five clinical programs in neurodegeneration and one clinical program in DISEASE DRUG SALES oncology planned by close of 2021 ARE EXPECTED TO § Multi-therapeutic pipeline with emphasis on neurodegeneration in
Slide 4: Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease
COMPANY HIGHLIGHTS: MULTI-THERAPEUTIC PIPELINE Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease 4COMPANY HIGHLIGHTS: MULTI-THERAPEUTIC PIPELINE Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease 4
Slide 5: IKT Parkinson's Disease Market & Strategy
IKT Parkinson’s Disease Market & Strategy IKT Parkinson’s Disease Market & Strategy
Slide 6: The Market: 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 7: Common Features of Misfolded Protein Diseases
COMMON FEATURES OF MISFOLDED PROTEIN DISEASES Causation in Parkinson’s and Alzheimer’s is closely 1 related What role does the misfolded protein play? 1 Nat. Neurosci. 21: 1332-1340 (2018) 7COMMON FEATURES OF MISFOLDED PROTEIN DISEASES Causation in Parkinson’s and Alzheimer’s is closely 1 related Wh
Slide 8: Cause of Neurodegeneration
CAUSE OF NEURODEGENERATION Evaluation of the Misfolded Protein ‘Seed’ in Parkinson’s Reveals c-Abl as the Primary Culprit, NOT the Misfolded Protein § Parkinson’s Disease (PD) is a neurodegenerative disease which limits function of nerve cells throughout the brain and gut following misfolding of non
Slide 9: The Path to Neurodegeneration
THE PATH TO NEURODEGENERATION Stressors Trigger the Production of Misfolded α-Synuclein 2 Which Activates c-Abl to Drive Neurodegeneration 1 Nat Rev Neurosci. 2, 492–501 (2001) 2 Werner and Olanow (2021), under review 3 https://ir.prothena.com/news-releases/news-release-details/update-phase-2-pasade
Slide 10: The Path to Disease Modification
THE PATH TO DISEASE MODIFICATION Biochemistry of Parkinson’s Disease Initiation and 1 Progression Disease process Treatment effect 1 Werner and Olanow (2021), under review, J Clin Invest. 2016; 126: 2970-2988 , Brain 2019; 142:2380-2401 , Cell 2011; 144: 689-702 , Nat Neurosci. 2013; 16: 1392-1400 ,
Slide 11: How Inhibikase Will Modify Disease
IKT How Inhibikase Will Modify Disease
Slide 12: IkT-148009: Low Toxicity, Selective, Brain Penetrant c-Abl Inhibitor
IS A SMALL MOLECULE c-ABL INHIBITOR IkT-148009: Low Toxicity, Selective, Brain Penetrant c- Abl Inhibitor in Clinical Development Selective Inhibitor of c-Abl and Abl2/Arg No organ toxicity bypasses toxicity of cancer drugs High brain penetrance 1 Table 1: IC of Commercial c-Abl inhibitors for inhib
Slide 13: Modifies Disease: Blocks Four Pillars of Parkinson's in Animal Models
MODIFIES DISEASE c-Abl inhibition by IkT-148009 blocks the four pillars of Parkinson’s Disease in Validated Animal Models a-Synuclein Toxicity Neurodegeneration Motor Dysfunction Neuroinflammation IkT-148009 clears to IkT-148009 preserves IkT-148009 restores IkT-148009 suppresses baseline in the as
Slide 14: IKT Clinical Development
IKT Clinical DevelopmentIKT Clinical Development
Slide 15: Phase 1 Trial in Safety and Dosing: Demographics
PHASE 1 TRIAL IN SAFETY AND DOSING Phase 1:Dose Proportional Clinical Pharmacokinetics and No Clinically Significant Adverse Events Category Demographic Value (% of Total N=42) Gender Female 12 (28.6) Male 30 (71.4) Age Average (SD) 56.2 (6.33) Median 56.5 Range 45, 68 Ethnicity Hispanic or Latino 6
Slide 16: Phase 1: Dose Proportional Clinical Pharmacokinetics
PHASE 1 TRIAL IN SAFETY AND DOSING Phase 1:Dose Proportional Clinical Pharmacokinetics and No Clinically Significant Adverse Events 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
Slide 17: Phase 1: Low Oral Dose Reaches Therapeutic Exposures of Animal Models
PHASE 1 TRIAL IN SAFETY AND DOSING Phase 1: Low Oral Dose in Humans Reaches 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 2
Slide 18: 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 1 analysis The Gut-Brain Connection Enables Innovation in Trial Design Parkinson’s May Begin in the Gut Easy access Can demon
Slide 19: Ongoing Trials in Safety and Dosing
ONGOING TRIALS IN SAFETY AND DOSING Updated Phases and Development Intervals for 2021 Phase 1b Multiple Ascending Dose (MAD): 7-Day Multiple Ascending Dose (MAD): 3 Mos § 3 dosing cohorts, 3:1 randomized with placebo, doses § 3 dosing cohorts determined from SAD PK and safety § Treatment native/Earl
Slide 20: Selected Financial and Stock Data
25,133,345 COMPANY HIGHLIGHTS Selected Financial and Stock Data Capitalization Table June 30, 2021 Common Shares Outstanding 25,133,345 Options (WAEP: $2.47) 3,624,658 Warrants (WAEP: $5.21) 1,561,913 Fully Diluted Shares Outstanding 30,319,916 $20.4M non-dilutive grant revenue pre-IPO (NIH, DoD, St
Slide 21: Upcoming Milestones
COMPANY HIGHLIGHTS Upcoming Milestones ØRemainder of 3Q21 • 148009 Ø Initiate dosing in Parkinson’s patients (H&Y < 2.5), 3:1 randomized, 8 patients/cohort, 7 day dosing. Up to 3 cohorts. Goal is Safety, PK, Exploratory measures in brain and GI for PD Ø Complete 100mg SAD and 25 mg MAD in healthy su
Slide 22: Management Team with Deep Experience in Drug Development and Commercialization
ABOUT US Management Team with Deep Experience in Drug Development and Commercialization Executive Milton Werner, PhD President & 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 Biophysic
Slide 23: Board of Directors and Industry-Leading Advisors
Board of Directors Industry-Leading Advisors Mr. Dennis Berman Dr. Roy Freeman, MD Robert Hauser, MD • Co-founder, board member, and/or seed investor in many Professor of Neurology, University of South Florida • Professor of Neurology at the Harvard Medical School and private biotechnology and techn
Slide 24: Appendix: Proof of the Importance of c-Abl in Disease
IKT Appendix Proof of the importance of c-Abl in Disease, Target Engagement and Functional Reversal in the Brain and GutIKT Appendix Proof of the importance of c-Abl in Disease, Target Engagement and Functional Reversal in the Brain and Gut
Slide 25: 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 26: Pathologic c-Abl-Modified α-Synuclein (pY39) in Parkinson's Patient Brain
STUDY Pathologic, c-Abl-Modified α-Synuclein (pY39) is 1 Present in 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) 26STUDY Pathologic, c-Abl-Modified α-Synuclein (pY39
Slide 27: 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 Treatment Started 6 Weeks After Near Normal Behavior Returned Are Introduced Into One Coordination Onset of Conditions
Slide 28: 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 28 Normal Mice Normal Mice +148
Slide 29: 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 30: 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 At 3 months defecation slows to 500 min (3x normal); At 6 months Into Gut Slows Gut Tran
Slide 31: Effect on Cause of Disease: 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 32: 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
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