Exhibit 99.1 3Q 2022 | BUSINESS PRESENTATION Clinical Development of Disease-Modifying Therapeutics for Neurodegenerative Disease & Cancer Inhibikase.com : IKT
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 under the securities laws of any such state or jurisdiction. 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 forward-looking statements to be covered by the safe harbor provisions for forward-looking statements in those sections. Generally, we have identified such forward-looking statements by using the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “project,” “target,” “forecast,” “aim,” should, “will,” may”, “continue” and similar expressions. Such statements are subject to a number of assumptions, risks and uncertainties which may cause actual results, performance or achievements to be materially different from those anticipated in these forward-looking statements. You should read statements that contain these words carefully because they discuss future expectations and plans which contain projections of future clinical studies, regulatory approvals, product candidate development, results of operations or financial condition or state other forward-looking information. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. Forward-looking statements are not historical facts, but instead represent only the Company’s beliefs regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Management believes that these forward-looking statements are reasonable as of the time made. However, caution should be taken not to place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the Company's historical experience and our present expectations or projections. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly Form 10-Q, including under the caption Risk Factors”. We do not intend our use or display of other entities’ names, trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity. Inhibikase.com • : IKT 2
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 therapeutics by modeling human disease using the Company’s Re-engineering Approach with Metabolism Preserved (RAMP) medicinal chemistry platform • IkT-148009: Lead Abelson Tyrosine Kinase (c-Abl) inhibitor program has the potential to be a disease-modifying treatment for Parkinson’s disease (PD) and related disorders. Phase 2a '201' study open for enrollment. • IkT-001Pro: First oncology product is a BCR-Abl inhibitor with a potentially improved safety profile to standard of care imatinib mesylate for leukemias and gastrointestinal cancers. Submitted IND application for Chronic Myeloid Leukemia. • Robust patent portfolio with protection to 2033 (oncology) and 2036 (neurodegeneration). • $20.8 million in grants and contracts from NIH, DoD, the Michael J. Fox Foundation and the Georgia Research Alliance, all peer-reviewed; $63 million gross proceeds in investor capital in 2021 • Highly experienced management team, consultants, Board of Directors and Scientific Advisory Board Inhibikase.com • : IKT 3
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 progress PRECLINICAL CLINICAL CAN BE USED DRUG DRUG PRECLINICAL studies; white arrows represent planned TARGET TARGET FOR PATIENT MODALITY DISEASE INDICATION PHASE 1/1B PHASE 2 PHASE 3 TARGET CANDIDATE DEVELOPMENT approaches for future clinical studies. ENGAGEMENT ENGAGEMENT SELECTION (2). Four indications will be pursued for Neurodegeneration Yes IkT-148009 in PD, which will be pursued through two INDs, one Small Parkinson’s Disease: focused on treatment in the brain in c-Abl IkT-148009 treatment naïve or early-stage patients molecule Treatment Naive and the second focused on GI complications. MSA is a Parkinson’s- Small Parkinson’s Disease: c-Abl IkT-148009 Validated Validating Yes like disease to enter clinical 4 Indications Pursued molecule Early Stage development at Phase 2 sharing the Through 2 INDs. Shares Phase 1 data for 148009 with 2 Small Same Phase 1 and 2 PD. MSA moves forward in clinic c-Abl IkT-148009 Neurogenic Constipation Validated Validating Yes molecule ONLY if animal model study ongoing is positive. Small c-Abl IkT-148009 Dysphagia Validated Validating Yes molecule (3). For biomarker status, ‘Validated’ refers to proof of target engagement in Small IMPD/CTAs to be filed in EU, IND to be filed FDA,2022 c-Abl IkT-148009 Multiple System Atrophy Validated Validating Yes the target tissue which has been 2 molecule and 2023. Shares Same Phase 1 performed using rodent tissues and fluids. We are currently developing Oncology methods for using clinical samples for validating our ability to confirm target engagement in patients. ‘Validating’ in Small Stable-phase CML (orphan 505(b)(2) Path to Market BCR-Abl IkT-001Pro Validated Validated Yes this context indicates ongoing efforts to molecule indication) prove target engagement using proprietary sources and methods under development from human tissues and Research Phase fluids. Target engagement measures if and to what extent a compound Small Dementia with occupies its target. ‘Can be used for c-Abl IkT-148x Validated Validating Unknown molecule Lewy Body patient selection’ refers to our ability to use one or more markers we are Small currently ‘Validating’ to screen patients c-Abl IkT-148x Multiple System Atrophy Validated Validating Unknown molecule for the presence of that marker as a means of defining the patients most Small Progressive multifocal likely to benefit from the proposed c-Abl IkT-1427 Validated Validating Yes molecule leukoencephalopathy treatment. Inhibikase.com • : IKT 4
Parkinson’s Disease Market & Parkinson’s Disease Market & Strategy Strategy Inhibikase.com • : IKT 5
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 38,000 60 New Cases / Year Deaths / Year Average Age Of Onset Sales estimates by 2025 are expected to exceed Other illnesses complicate development $6.0 BILLION Men twice Pharma Insights, 2019 as likely as women to The country with the highest diagnosed prevalence is contract 47% 30% 35% 36% disease Arthritis Heart/Circulatory Psychosis Dementia THE U.S. DelveInsight, 2019 1 Parkinson’s Disease Foundation Decisions Resources 2016, Lewin Report in the Economic Burden and Future Impact of Parkinson’s disease, 2019.. Inhibikase.com • : IKT 6
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
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
How Inhibikase Will Modify Parkinson’s Disease: C-Abl Kinase Inhibition with IkT-148009 Inhibikase.com • : IKT 9
A MEDICINAL CHEMISTRY APPROACH THAT BUILDS ON EXISTING KNOWLEDGE TM Discovery using a Re-engineering Approach with Metabolism Preserved (RAMP ) Inhibikase.com • : IKT 10
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 • Selective Inhibitor of 80 Sternum None c-Abl1 and Abl2/Arg Blood None 60 PBMCs Slight increase in • Design suppressed neutrophils within toxicity of cancer 40 normal limits drugs in this class Cytotoxicity None in primary 20 or mature cells • Low or no apparent organ toxicity at current Sustained brain > 1 micromolar 0 level of knowledge c-Abl1 c-Abl2/Arg c-Kit PDGFRa PDGFRb concentration 1 13 week and 39 week toxicology data shows IkT-148009 • High brain penetrance Inhibition of these enzymes leads to toxicity has a more favorable toxicity profile as dosing is extended Inhibikase.com • : IKT 11 IC (nm) 50 0.6 48 33 1 41 14 31 5 90 100 28 72 100 28 72 Greater Inhibition
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 near baseline organs of disease of brain neurons of lost function in the organs of disease 1 Werner and Olanow, Mov. Disord. (2021) 37:6-15. Inhibikase.com • : IKT 12
Clinical Development of IkT-148009 Inhibikase.com • : IKT 13
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 Average (SD) 57.9 (5.72) 62.5 Median 58.0 62 IkT-148009 does not Range 45, 69 57, 70 lead to typical c-Abl Ethnicity Hispanic or Latino 13 (14.8) 3 (23.1) inhibitor adverse events: Not Hispanic or Latino 75 (85.2) 10 (76.9) No GI Race Black or African American 54 (61.4) 2 (15.4) No Cardiovascular White 33 (37.5) 11 (84.6) No Hematological Other 1 (1.1) 0 (0) Adverse events 7 (7.9), all clinically insignificant 5 (38.5) Inhibikase.com • : IKT 14
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 4000 PHARMACOKINETICS 120000 100000 3000 High exposures at low oral 80000 dose; linearly dose 2000 proportional up to 175 mg. 60000 Exposures at 75 mg IkT- 40000 148009 comparable to 1000 1 20000 500 mg imatinib Therapeutic dosing range 1 0 0 FDA summary data for approval 21-335 0 20 40 60 80 100 120 140 160 180 Oral Dose (mg) Inhibikase.com • : IKT 15 Mean Cmax (ng) Mean AUC 0-∞ (ng-h/mL
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
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 cohort Epworth Sleepiness Scale, NMSS, PDQ-39, CSBM, PAGI-SYM, PAC-QOL, PAGI-SYM-QOL • 120 patients’ total • Exploratory endpoints: Phospho-alpha-synuclein in • 30 patients/dose 1:1:1:1 randomized GI, Skin and CSF; Whole Gut Transit Time 12-week dosing 1x/day TM (SmartPill ) • Treatment naïve/Early stage patients • Descriptive statistics (Hoehn & Yahr ≤ 3.0) Why just 3 months?: • Primary endpoints: safety, tolerability Animal GI Recovery < 4 weeks Animal Brain Recovery < 8 weeks Inhibikase.com • : IKT 17
Stable-Phase Chronic Myelogenous Leukemia Market and Strategy Inhibikase.com • : IKT 18
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 compliance and relapse • Second generation treatments have severe ® ® adverse events (i.e. Sprycel or Tasigna ) ® • Best approach in our view: reduce Gleevec side effects 1 Jabbour E, Kantarjian H. Am. J. Hematol. 89:548–556 2 IMS-Iqvia retail sales data 2016-2020 3 Am J. Hematology (2019) 94:46-54 4 Annals of Hematology (2018) 97:1357–1367 $330.5 million in net U.S. Sales > 57% market share 50% of recipients experience u u u 2 ® for branded and generic Gleevec® Generic Gleevec Grade 2 GI adverse events Inhibikase.com • : IKT 19
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
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) NOAEL including use of higher dosing due to lower AEs Imatinib 176/206 4/3 1540/1960 15 1 (Day 91) (M/F) (M/F) (M/F) ü Suppress GI and other adherence-related adverse IkT-001Pro 400/318 5.3/3.7 5220/3890 75 events (Day 28) (M/F) (M/F) (M/F) 1 FDA summary data for approval 21-335 ▲ ▲ NO ADVERSE EVENTS 3x 3x increased exposure higher dose of imatinib delivered as 001Pro Inhibikase.com • : IKT 21
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 mg imatinib mesylate IkT- 001Pro measuring 96 hr pharmacokinetics Bioequivalence • Part 2: Confirmatory single dose measure in 32 subjects confirming 96 hr pharmacokinetics ‘501’ Trial • Will confer with FDA on NDA path under the 505(b)(2) statute following the 501 trial Superiority to standard of care in CML IkT- 001Pro • Wait-list control crossover design comparing 001Pro to 400 mg imatinib over 6 months • 98 patients dosed 1x/day Planned • Primary endpoints are patient-reported outcome measures of GI disturbance and frequency ‘502’ Trial of diarrhea. • Planned to conduct ‘502’ trial coincident with pursuit of NDA under the 505(b)(2) statute Inhibikase.com • : IKT 22
Selected Stock and Financial Data In Inh hiib biik ka as se e.c .co om m • • :: IK IKT T 23 23
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 Fully Diluted Shares Outstanding 30,622,020 Prepaid research and $919,053 development $20.8M non-dilutive grant revenue pre-IPO (NIH, DoD, State gov’ts) Prepaid expenses and other $811,482 current assets Total Current Assets $33,949,363 Total Current Liabilities $4,490,305 Working Capital $29,459,058 Active grant funding available in $314,228 accounts held by the U.S. treasury Total Working Capital $29,773,286 Inhibikase.com • : IKT 24
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 pill formulation for letter IkT-148009 and effect of food on PK in PD patients • Design and develop superiority study for • Complete first of two animal model validation studies of IkT-001Pro relative to standard-of-care in CML IkT-148009 in MSA • Begin business development efforts for commercial • File IND for IkT-148009 in the US for MSA; Seek orphan partnership drug designation in the US • Begin characterizing novel compounds as follow-ons to IkT-148009 Inhibikase.com • : IKT 25
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 served as Director of Mr. Frattaroli is a certified public Research at Celtaxsys. From September 1996 until accountant with more than 15 years of Dr. Olanow is the former Henry P. and Georgette Goldschmidt Professor and Chairman of June 2007, Dr. Werner was a Head of the experience in public company filings and the Department of Neurology at the Mount Sinai School of Medicine Prior to joining Mount Laboratory of Molecular Biophysics at The compliance for Nasdaq and OTC Markets Sinai, he served on the faculties of McGill University, Duke University, and the University of Rockefeller University in New York City. Throughout companies. Previously, he provided chief South Florida. He is the former President of the Movement Disorder Society, past President of the International Society of Motor Disturbances, and former Treasurer of the American his scientific career, Dr. Werner has been an financial officer and consulting services for Neurological Association. He has served on the executive committee of the Michael J. Fox innovator integrating chemistry, physics, and biology several emerging biopharmaceutical and Foundation Scientific Advisory Board, and he is the former Chairman of the Scientific into a comprehensive approach to solving problems medical device companies, with Advisory Board of the Bachmann-Strauss Parkinson Foundation and of the Dystonia in medicine. Dr. Werner is the author or co-author of responsibilities that included capital Foundation. Dr. Olanow is the former Co-Editor-in-Chief of the journal Movement Disorders. more than 70 research articles, reviews, and book formation, deal structuring, and assisting Dr. Olanow received his medical degree from the University of Toronto, performed his chapters and has given lectures on his research private companies in their transition to neurology training at the New York Neurological Institute at Columbia Presbyterian Medical work throughout the world. becoming publicly traded SEC registrants. Center at Columbia University, and undertook postgraduate studies in neuroanatomy at Columbia University and authored more than 600 articles in the field of neurodegeneration. Inhibikase.com • : IKT 26
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 School and Director of the small-molecule research and Company, lastly serving as Chief biotechnology and technology Center for Autonomic and Peripheral development, including the successful Procurement Officer and Leader, companies, five of which have gone Nerve Disorders in the Department of approval and commercialization of Global Head of Shared Services public. Neurology at Beth Israel Deaconess products in the infectious diseases, • Served in senior management at Lilly • Currently serves as the President of Medical Center immunology, and oncology therapeutic including Senior Vice President, Policy Molino Ventures, LLC a board • Former chairman of the World areas. and Finance; Senior Vice President, advisory and venture capital firm and Federation of Neurology research • Director of Amplyx Pharmaceuticals Finance; Chief Financial Officer, Lilly was co-founder and Executive Vice group on the autonomic nervous and Synedgen. USA; Chief Financial Officer, Lilly President of Corporate Development system, former President of the • Served in senior management roles at Canada; and General Auditor. Before of Tocagen. American Autonomic Society, and Cerexa, Forest Laboratories, joining Eli Lilly, Ms. • Seed investor, co-founder, and/or former chairman of the Autonomic Kalypsys, Pfizer, IDEC • Director of PDL BioPharma, Geron board member of Intervu, Kintera, Section of the American Academy of Pharmaceuticals, and Schering- Corporation and Lensar Inc., Gensia, Calabrian Neurology. Plough Corporation. • BS in accounting with honors and an • Editor-in-Chief of Autonomic • Fellow of the Royal College of MBA in management information Neuroscience: Basic and Clinical and Pathologists and a medical degree systems from Indiana University. on the editorial boards of The Clinical from St. Bartholomew’s Hospital Journal of Pain, Pain: Clinical College, University of London. Updates, and Clinical Autonomic Research. • Serial founder of several companies in pain and neurodegenerative disease and is on the scientific advisory boards of many large and small pharmaceutical and biotechnology companies. Inhibikase.com • : IKT 27
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 Neurology and Physiology Clinical Research, Director of the Clinical &Translational Science South Florida College of Medicine - The Johns Hopkins University School of Medicine Institute, Founder Center for Human Experimental Therapeutics Director USF Parkinson’s Disease and (CHET)- University of Rochester Medical Center Movement Disorders Center President Clintrex Research Corporation Dr. Warren Olanow, MD, FRCPC Henry P. and Georgette Goldschmidt Professor and Chairman Jeffrey Kordower, PhD Dr. Jay Pasricha, MBBS, MD Emeritus, Mount Sinai School of Medicine Founding Director ASU-Banner Neurodegenerative CEO, Clintrex Research Corporation Director, Johns Hopkins Center for Neurogastroenterology Disease Research Center (NDRC) Professor of Medicine The Charlene and J. Orin Edson Distinguished Director at the Biodesign Institute Professor of Life Sciences Arizona State University Dr. Ken Marek President and Senior Scientist, Institute of Neurodegenerative Disorders Dr. Ted Dawson, MD, PhD Neurodegeneration and Stem Cell Programs, Institute for Cell Engineering, Departments of Neurology, Physiology, Pharmacology, and Molecular Sciences - The Johns Hopkins University School of Medicine Inhibikase.com • : IKT 28
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