Inhibikase Therapeutics, Inc. · NASDAQ:IKT
Inhibikase Therapeutics — Investor Presentation (October 2024)
33 slides from Inhibikase Therapeutics's investor presentation, Oct 9, 2024
Slide 1: PAH Business Presentation
Exhibit 99.1 PAH | BUSINESS PRESENTATION Clinical Development of Disease-Modifying Therapeutics for Pulmonary Arterial Hypertension Inhibikase.com : IKT
Slide 2: Disclaimer
DISCLAIMER This presentation contains information that may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. Inhibikase Therapeutics, Inc. (the “Company” or “we”) intends for the forwar
Slide 3: Multi-Therapeutic Pipeline of Kinase Inhibitor Therapeutics
MULTI-THERAPEUTIC PIPELINE OF KINASE INHIBITOR THERAPEUTICS Developing innovative medicines across the therapeutic spectrum • Multi-therapeutic pipeline across cardiopulmonary disease, neurodegenerative disease and cancer. • IkT-001Pro: Prodrug of imatinib mesylate to be evaluated in Pulmonary Arter
Slide 4: IkT-001Pro for Treatment of Pulmonary Arterial Hypertension
IkT-001Pro for Treatment of Pulmonary Arterial Hypertension IIn nh hiib biik ka as se e..c co om m • • :: IIK KT T 4 4
Slide 5: Pulmonary Arterial Hypertension: A Complex Disease with Mortality on Par with Cancer
1 PULMONARY ARTERIAL HYPERTENSION: A COMPLEX DISEASE WITH MORTALITY ON PAR WITH CANCER PAH mortality on par with many Complex disease etiology leading to narrowing 2 1 Cancer Indications of lung microvasculature Dysfunctional Pulmonary Epithelium • Vasodialators and vasoconstrictors working against
Slide 6: New Treatment Options for PAH Remain a High Unmet Need
1 NEW TREATMENT OPTIONS FOR PULMONARY ARTERIAL HYPERTENSION REMAIN A HIGH UNMET NEED Only 1 approved Disease Modifying drug: Sotatercept (Merck). No oral disease-modifying therapies approved 1 2023 Sales ($B) for existing therapies that only treat symptoms $1.9 Projected sales by 2026 $2.6 for first
Slide 7: Current Standard of Care and the Potential Role of Imatinib
CURRENT STANDARD OF CARE AND THE POTENTIAL ROLE OF IMATINIB 1 Imatinib inhibits the Platelet-derived growth factor receptor (PDGFR), blocking cell signaling that drives 2 proliferation. Shown to be disease-modifying Sotatercept Anti-prostacyclin ERAs Sotatercept blocks a different proliferative path
Slide 8: History of Imatinib Therapy in PAH
HISTORY OF IMATINIB THERAPY IN PAH 2010: Small proof-of-concept trial demonstrates 2013: P3 IMPRES trial -> Imatinib hits stat 2005: Off-label use of imatinib elicits disease that Imatinib improves hemodynamics and sig on primary endpoint of 6MWD as well 1 control in advanced PAH patient 2 3 6MWD in
Slide 9: Imatinib and Sotatercept Have Comparable Efficacy
IMATINIB AND SOTATERCEPT HAVE COMPARABLE EFFICACY Imatinib data from Ph3 IMPRES has comparable efficacy to Sotatercept from Ph3 STELLAR 1-5 data PULMO NA RY VASCULA R RESISTA NCE 6-MINUTE WA LK DISTAN CE 0 50 Placebo Adjusted Values -50 45 40 -100 35 -150 30 -200 25 -250 20 -300 15 -350 10 -400 5 -4
Slide 10: Why imatinib failed to be approved
Why imatinib failed to be approved IIn nh hiib biik ka as se e..c co om m • • :: IIK KT T 10 10
Slide 11: Serious Adverse Events in the IMPRES Study
SERIOUS ADVERSE EVENTS IN THE IMPRES STUDY Imatinib was not approved because of high discontinuation rate in IMPRES Ph3 1-2 AEs mimicked disease symptoms as such mimicry could suggest clinical worsening Adverse Events included: • Subdural Hematoma • Edema and Fatigue may mimic symptoms of disease •
Slide 12: Solving the Problems with Imatinib: Suppression of Subdural Hematoma
SOLVING THE PROBLEMS WITH IMATINIB: SUPPRESSION OF SUBDURAL HEMATOMA ALL patients with subdural hematoma treated with old-style anti-coagulants 1-2 Subdural hematoma didn’t occur in the absence of anti-coagulants Imatinib significantly increases exposure of the anti- coagulants used in these patient
Slide 13: Solving the Problems with Imatinib: Properly Analyzing Adverse Events Like Edema
SOLVING THE PROBLEMS WITH IMATINIB: PROPERLY ANALYZING ADEVERSE EVENTS LIKE EDEMA 1-2 From IMPRES manuscript GI and edema adverse event rate on Imatinib is similar in IMPRES and contemporary CML trials. However, discontinuation rate was AEs largely similar to those much higher in IMPRES. seen in oth
Slide 14: Solving the Problems with Imatinib: Frequency of GI Side Effects Depends on Dose
SOLVING THE PROBLEMS WITH IMATINIB: FREQUENCY OF GI SIDE EFFECTS DEPENDS ON DOSE Adverse Placebo Imatinib Adverse Imatinib Imatinib 1 2 2 Event (n=98) (n=103) Event 200-300mg 350-500mg % Occurrence % Occurrence Nausea 23 (24%) 57 (55%) Nausea 30% 50% Diarrhea 19 (19%) 36 (35%) Diarrhea 4% 33% Vomiti
Slide 15: Imatinib delivery by prodrug
Imatinib delivery by prodrug IIn nh hiib biik ka as se e..c co om m • • :: IIK KT T 15 15
Slide 16: Solving the Problems with Imatinib: Masking the Chemical Surface Driving GI AEs
SOLVING THE PROBLEMS WITH IMATINIB: MASKING THE CHEMICAL SURFACE DRIVING GI AEs IkT-001Pro, a prodrug of imatinib, designed to mask imatinib at the gut wall 4-carbon atom linker imatinib linker gut wall + pH 2-6 pH 7 (blood) (stomach, ileum, duodenum) Lifetime in blood < 10 min Inhibikase.com • : IK
Slide 17: IkT-001Pro Is a Small Molecule Imatinib Prodrug
IkT- 001Pro IS A SMALL MOLECULE IMATINIB PRODRUG IkT-001Pro: Anticipated lower GI toxicity alternative to imatinib Measurement of IkT-001Pro orally delivered once daily in Non-Human Primates RESULTS SUGGEST POTENTIAL No Adverse Event Level TO: Doses studied Cmax Tmax AUC 0-T (mg/kg/day) (mg/kg/day)
Slide 18: Clinical Experience with IkT-001Pro
C (ng/mL) max CLINICAL EXPERIENCE WITH IkT- 001Pro Bioequivalence and Linear PK over the effective range Dose Linearity of 001Pro • Bioequivalence of IkT-001Pro 60000 3500 established to cover a dosing y = 62.101x + 4087.3 range between 230 and 600 R² = 0.9126 3000 50000 mg imatinib delivered • No c
Slide 19: Choosing the Right Dose of IkT-001Pro
CHOOSING THE RIGHT DOSE OF IkT- 001Pro IKT-001Pro at bioequivalent dose to 400 mg imatinib observed to Trough concentrations observed in human cancer have comparable exposures in humans patients or in PAH Oral Dose C Trough observed trough IMPRESS 1 1 2 (mg) (ng/mL) (ng/mL) 140 279 ± 38 300 886 ±752
Slide 20: IkT-001Pro Potential as a Branded Drug in PAH
IkT- 001Pro POTENTIAL AS A BRANDED DRUG IN PAH Regulatory and IP Status: IkT-001Pro is a New Molecular Entity for PAH Pre-IND Meeting with FDA April 5, 2024 IP protection out to 2039-2044+ • Agency agreed that lower dosing, improved safety Composition of Matter profile in NHP studies may mitigate sa
Slide 21: Advantages of 001Pro in PAH
ADVANTAGES OF 001Pro in PAH Summary of why imatinib delivered by IkT-001Pro could be impactful • IkT-001Pro is a Phase 3 ready asset for PAH following IND clearance • Imatinib is proven to be effective in PAH • High unmet need to improve the lives of patients, sotatercept isn’t enough • IP protectio
Slide 22: Outline of IkT-001Pro Development Program
OUTLINE OF IKT-001PRO DEVELOPMENT PROGRAM Ph2b Trial (Registrational?) Ph3 Trial N=150 Primary EPs: Primary EPs: Placebo Placebo N~160 1:1:1 - PVR - 6MWD IKT001-Pro 300 mg 1:1 • No anti-coagulants or - Safety >1 anti-platelet IKT001-Pro Selected Dose randomization IKT001-Pro 500 mg therapy • Stratif
Slide 23: Leading Clinical Scientists in PAH Dedicated to Company's PAH Program
LEADING CLINICAL SCIENTISTS IN PAH DEDICATED TO COMPANY’S PAH PROGRAM Dr. Marc Humbert, MD Dr. Marius Hoeper, MD President of the European Respiratory Society, Marc Marius M. Hoeper, MD, is deputy director of the Humbert is Professor of Respiratory Medicine, Vice Dean Department of Respiratory Medic
Slide 24: Lessons from IMPRES
Lessons from IMPRES -> ‘Imatinib is an efficacious drug for patients with PAH. With contemporary trial design and Inhibikase’s prodrug approach, I believe IkT001-Pro can be a differentiated therapy for patients.’ Marius Hoeper, MD Inhibikase.com • : IKT 24
Slide 25: About Us / Executives
ABOUT US / EXECUTIVES Management Team with Deep Experience in Drug Development and Commercialization Milton Werner, PhD Garth Lees-Rolfe C. Warren Olanow, MD, President & CEO Chief Financial Officer Medical Consultant and Chief Executive Officer of Clintrex Research Corporation. Previously, Dr. Wern
Slide 26: PAH | Appendix
PAH | APPENDIX Clinical Development of Disease-Modifying Therapeutics for Pulmonary Arterial Hypertension Inhibikase.com : IKT Inhibikase.com • : IKT 26
Slide 27: Summary Adverse Events
SUMMARY ADVERSE EVENTS Adverse Events observed during bioequivalence clinical studies # Occurrences # Occurrences # occurrences # occurrences Category Severity Category Severity 1 600 mg IkT-001Pro 400 mg imatinib mesylate 800 mg IkT-001pro 600 mg imatinib mesylate 1 1, 2 1 (n=8) (N=64) (N=55) (n=8)
Slide 28: Inclusion Criteria for the Trial
INCLUSION CRITERIA FOR THE 702 TRIAl INCLUSION 1. Men and women between the ages of 18 and 70 years of age (inclusive) at the time of signing the informed consent. 2. Capable of giving signed ICF which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Slide 29: Exclusion Criteria for the Trial
EXCLUSION CRITERIA FOR THE 702 TRIAL EXCLUSION 1. Diagnosis of PAH WHO Groups 2, 3, 4, or 5 14. Currently receiving moderate or strong Cytochrome P450 (CYP) 3A4/5 inducers or CYP3A4/5 2. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)- inhibitors (except for topic
Slide 30: Significant Unmet Need Remains Despite Recent Approval of Sotatercept
® SIGNNIFICANT UNMET NEED REMAINS DESPITE RECENT APPROVAL OF SOTATERCEPT (WINREVAIR ) Sotatercept (SC Q3W) was approved in 2024 as the first disease modifying therapy 1 Sotatercept demonstrated 6-minute walk and PVR benefit However, only a minority of PAH patients respond to Sotatercept in a clinica
Slide 31: Imatinib Demonstrated a Dose-Responsive Benefit in PAH
IMATINIB DEMONSTRATED A DOSE-RESPONSIVE BENEFIT IN PAH • IMPRES Ph3 Trial titrated patients from 200 mg QD for first 2 weeks to 400 mg QD if well tolerated. If not well tolerated, 1 patients remained on 200 mg QD. • 24/67 patients on imatinib were not able to stay on the 400 mg dose for ≥50% of the
Slide 32: Competition for TKIs
COMPETITION FOR TKIs Competitive landscape for TKIs 1 • Inhaled Seralutinib : Phase 2 trial outcome demonstrates inhaled seralutinib < 1/3 as effective as sotatercept/imatinib in haemodynamics, modest 6MWD improvement across all classes. 1 Poster, American Thoracic Society Annual Meeting, May 19-24,
Slide 33: Competition for TKIs
COMPETITION FOR TKIs Competitive landscape for TKIs 1 • Inhaled imatinib : Phase 2b studies of AV-101 demonstrate no efficacy whatsoever. Why? 2 Trough imatinib AV-101 on repeat dosing Trough imatinib in IMPRES 1 250 to 1250 ng/mL 534 ng/mL with 90 mg BID AV-101 Phase 2 trial only used 70 mg BID 1 2
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