Full Press Release Details
Clinical Development of Disease-
Modifying Therapeutics for Parkinson's and Related Disorders 2Q 2022 BUSINESS PRESENTATION IKT Exhibit 99.1
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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
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TREATING INSIDE AND OUTSIDE OF THE
BRAIN Simultaneous Evaluation of Brain and GI Function Expands the Definition of a Disease-Modifying Treatment PD is more than just a disease of the brain. GI manifestation in many patients occurs at an early stage, suggesting that evaluation of GI
and brain function could be essential to identifying truly disease-modifying treatments Utilization of slowly progressive, a-synuclein dependent animal models that reproduce the rate of disease progression relative to lifespan of the human disease
have been key to properly identifying potential disease-modifying therapeutics. Our lead asset is an inhibitor of the Abelson Tyrosine Kinase (c-Abl). IkT-148009, halts and reverses functional loss; discovered using slowly progressive animal models.
Six clinical programs in 2022 across two assets in Parkinson's disease, Multiple Systems Atrophy (orphan indication, orphan designation not sought) and Chronic Myelogenous Leukemia (orphan indication, orphan designation granted). Phase 2
programs anticipated to begin early 2Q22 in neurodegeneration, readouts anticipated within 12 months. Multiple patent families for lead compound with expiration of 2036 and beyond $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 and respected management team, consultants, Board of Directors and nearly all KOLs in the field on
Scientific Advisory Board
CLINICAL DEVELOPMENT1 BIOMARKER3 Drug
Target Drug candidate Modality Disease indication PRECLINICAL DEVELOPMENT PHASE 1/1b PHASE 2 PHASE 3 Preclinical target engagement Clinical target engagement Can be used for patient selection Neurodegeneration c-Abl IkT-148009 Small molecule
Parkinson's Disease: Treatment Na ve Validated Validating Yes c-Abl IkT-148009 Small molecule Parkinson's Disease: Early Stage Validated Validating Yes c-Abl IkT-148009 Small molecule Neurogenic Constipation Validated Validating Yes
c-Abl IkT-148009 Small molecule Dysphagia Validated Validating Yes c-Abl IkT-148009 Small molecule Multiple System Atrophy Validated Validating Yes Oncology BCR-Abl IkT-001Pro Small molecule Stable-phase CML (orphan indication) Validated Validated
Yes Research Phase c-Abl IkT-148x Small molecule Dementia with Lewy Body Validated Validating Unknown c-Abl IkT-148x Small molecule Multiple System Atrophy Validated Validating Unknown c-Abl IkT-1427 Small molecule Progressive multifocal
leukoencephalopathy Validated Validating Yes Clinical Development' progress bars represent the current state of the indicated programs. Blue arrows represent completed or in progress studies; white arrows represent planned approaches
for future clinical studies. Four indications will be pursued for IkT-148009 in PD, which will be pursued through two INDs, one focused on treatment in the brain in treatment nai ve or early-stage patients and the second focused on GI
complications. MSA is a Parkinson's-like disease to enter clinical development at Phase 2 sharing the Phase 1 data for 148009 with PD. MSA moves forward in clinic ONLY if animal model study ongoing is positive. For biomarker status,
Validated' refers to proof of target engagement in the target tissue which has been performed using rodent tissues and fluids. We are currently developing methods for using clinical samples for validating our ability to confirm target
engagement in patients. Validating' in this context indicates ongoing efforts to prove target engagement using proprietary sources and methods under development from human tissues and fluids. Target engagement measures if and to what
extent a compound occupies its target. Can be used for patient selection' refers to our ability to use one or more markers we are currently Validating' to screen patients for the presence of that marker as a means of
defining the patients most likely to benefit from the proposed treatment. 4 Indications Pursued Through 2 INDs. Shares Same Phase 12 505(b)(2) Path to Market IMPD/CTAs to be filed in EU, IND to be filed FDA,2022. Shares Same Phase 12
Multi-Indication Pipeline in Neurodegeneration, Oncology and Infectious Disease COMPANY HIGHLIGHTS: MULTI-THERAPEUTIC PIPELINE
Parkinson's Disease Market &
Large Market, Opportunity For Disease
Modification AVERAGE AGE OF ONSET 60,000 NEW CASES / YR Other illnesses complicate development ARTHRITIS HEART / CIRCULATORY PSYCHOSIS DEMENTIA 47% 36% 35% 30% 700,000 - 1,000,000 U.S. Patients 38,000 DEATHS / YEAR Chronic Disease for a Long
Time 1/3 of a Patient's Lifespan = 25 years 60 Men twice as likely as women to contract disease Parkinson's Disease in the U.S.1 THE MARKET 1Parkinson's Disease Foundation Decisions Resources 2016, ParkinsonismRelatDisord .
2012;18:1073-1078, Neuroepidemiology 2010;34:143-151 , J Neurol Neurosurg Psychiatry. 1997 Jan;62(1):10-5. Double BY 2025, PARKINSON'S DISEASE DRUG SALES ARE EXPECTED TO $6.0 Billion SALES ESTIMATES BY 2025 ARE EXPECTED TO CREST Pharma
Insights, 2019 Pharma Insights, 2019 The U.S. THE COUNTRY WITH THE HIGHEST DIAGNOSED PREVALENCE IS DelveInsight, 2019
Causation in Parkinson's and
Alzheimer's is closely related1 COMMON FEATURES OF MISFOLDED PROTEIN DISEASES What role does the misfolded protein play? 1Nat. Neurosci. 21: 1332-1340 (2018)
CAUSE OF NEURODEGENERATION Evaluation
of the Misfolded Protein Seed' in Parkinson's Reveals c-Abl as the Primary Culprit (video)
THE PATH TO NEURODEGENERATION Stressors
Trigger the Production of Misfolded -Synuclein Which Activates c-Abl to Drive Neurodegeneration2 1Nat Rev Neurosci. 2, 492-501 (2001) 2 Werner and Olanow , Mov Disorders 2021, doi: 10.1002/mds.28858
How Inhibikase Will Modify Disease
Re-engineering Approach with
Metabolism Preserved (RAMPTM) IS A SMALL MOLECULE c-ABL INHIBITOR
IkT-148009: Low Toxicity, Selective,
Brain Penetrant c-Abl Inhibitor in Clinical Development Toxicology in Rat/Monkey1 Human equivalent dose of 1460 mg Cardiovascular None Renal None Liver None Bone marrow None Sternum None Blood None PBMCs Slight increase in neutrophils within normal
limits Cytotoxicity None in primary or mature cells Sustained brain concentration > 1 micromolar 113 week and 39 week toxicology data shows IkT-148009 has a more favorable toxicity profile as dosing is extended IS A SMALL MOLECULE c-ABL INHIBITOR
Selective Inhibitor of c-Abl and Abl2/Arg bypasses toxicity of cancer drugs1 No organ toxicity High brain penetrance 1See SelleckChem.com, Leuk 23:1689ff (2009) Inhibition of these enzymes leads to toxicity Greater Inhibition
MODIFIES DISEASE c-Abl inhibition by
IkT-148009 blocks the four pillars of Parkinson's Disease in Validated Animal Models a-Synuclein Toxicity IkT-148009 clears to baseline in the organs of disease Neurodegeneration IkT-148009 preserves as much as 85% of brain neurons Motor
Dysfunction IkT-148009 restores as much as 90% of lost function Neuroinflammation IkT-148009 suppresses to near baseline in the organs of disease
Clinical Development IKT
Phase 1: Dose Proportional Clinical
Pharmacokinetics and No Clinically Significant Adverse Events PHASE 1 TRIAL IN SAFETY AND DOSING Category Demographic Value (% of Total N=88) Gender Female 34 (38.6) Male 54 (61.4) Age Average (SD) 57.9 (5.72) Median 58.0 Range
45, 69 Ethnicity Hispanic or Latino 13 (14.8) Not Hispanic or Latino 75 (85.2) Race Black or African American 54 (61.4) White 33 (37.5) Other 1 (1.1) Adverse events 7 (7.9), all clinically insignificant No GI No Cardiovascular
Phase 1:Dose Proportional Clinical
Pharmacokinetics and No Clinically Significant Adverse Events PHASE 1 TRIAL IN SAFETY AND DOSING Significance of clinical pharmacokinetics High exposures at low oral dose, linearly dose proportional up to 175 mg. Exposures at 75 mg IkT-148009
comparable to 500 mg imatinib1 1FDA summary data for approval 21-335 Therapeutic dosing range
Phase 1b: Mild to Moderate PD
(H&Y < 3.0) and No Clinically Significant Adverse Events PHASE 1 TRIAL IN SAFETY AND DOSING Category Demographic Value (% of Total N=13) Gender Female 6 (42.8) Male 7 (57.2) Age Average 62.5 Median 62 Range 57, 70
Ethnicity Hispanic or Latino 3 (23.1) Not Hispanic or Latino 10 (76.9) Race Black or African American 2 (15.4) White 11 (84.6) Other 0 (0) Adverse events 5 (38.5), (pneumonia, spinal headache, dermatitis, constipation,
orthostatic hypotension)
Phase 1b:Pharmacokinetics similar to
elderly healthy subjects PHASE 1 TRIAL IN SAFETY AND DOSING 1FDA summary data for approval 21-335 T1/2 (h) Tmax (h) Cmax (ng/ml) AUC0-24 (ng-h/mL) Vz/F (l) CL (l/h) Day 1 Mean 25 mg 15.4 5 1040 12700 32.5 1.52 N=6 SD Healthy 11.3 4 419 6010 14.7
0.905 Day 7 Mean 27.4 4.67 1770 25400 42.8 1.1 N=6 SD 5.09 1.63 807 9260 15.3 0.384 Day 1 Mean 50 mg 10.1 4.67 1720 19400 37.2 2.51 N=6 SD PD 2.7 1.03 737 9470 22.8 1.2 Day 7 Mean 24.9 3.67 2560 32500 57.1 1.61 N=6 SD 3.86 1.51 564 8500 12.4 0.312
Trends in motor and non-motor scores and assessments and in GI function that may have occurred over 7 day-dosing need more cohorts to be completed to draw any conclusions.
Clinical Phase 1b and Phase 2
Programs ONGOING TRIALS IN SAFETY AND DOSING Phase 1b MAD (6-8 Months) Oct. 2021 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Multiple Ascending Dose (MAD): 7-Day Dosing 3 dosing cohorts, 3:1 randomized with placebo, doses determined from SAD
PK and safety 24 patients total 8 patients/dose 7-day dosing 1x/day Hoehn & Yahr (H&Y) < 3.0 Primary endpoints: safety, tolerability, pharmacokinetics (PK), urine, plasma and spinal fluid concentrations Phase 1b ONGOING Multiple Ascending
Dose (MAD): 3 Mos Dosing 3 dosing cohorts, 1 placebo cohort 120 patients total 30 patients/dose 3:1 randomized 13-week dosing 1x/day Treatment na ve/Early state patients (H&Y 2.0) Primary endpoints: safety, tolerability Phase 2a
2Q22 Phase 2a ( Up to 12 months) Multiple Ascending Dose (MAD): 7-Day Dosing Exploratory endpoints: UPDRS II, III, II+III, NMSS, PDQ-39, CSBM, PAGI-SYM Multiple Ascending Dose (MAD): 3 Mos Dosing Animal GI Recovery < 4 weeks Animal Brain Recovery
< 8 weeks Secondary endpoints UPDRS II, III, II+III, PGI-S, CGI-S, Epworth Sleepiness Scale, NMSS, PDQ-39, CSBM, PAGI-SYM, PAC-QOL, PAGI-SYM-QOL Exploratory endpoints: Phospho-a-synuclein GI, Skin and CSF; Whole Gut Transit Time (SmartPillTM)
Descriptive statistics Apr/May 2022
COMPANY HIGHLIGHTS Selected
Financial and Stock Data Balance Sheet December 31, 2021 (last reporting period) Current Assets: Cash $ 40,750,133 Grants Receivable $ 110,141 Prepaid research and development $ 107,000 Prepaid expenses and other current assets $ 1,502,725 Total
Current Assets $ 42,469,999 Total Current Liabilities $ 4,054,450 Working Capital $ 38,415,549 Active grant funding available in accounts held by the U.S. treasury $ 385,888 Total Working Capital $ 38,801,437 $20.8M non-dilutive grant revenue
pre-IPO (NIH, DoD, State gov'ts) Capitalization Table March 31, 2022 Common Shares Outstanding 25,227,051 Options (WAEP: $2.47) 4,208,056 Warrants (WAEP: $5.21) 1,561,913 Fully Diluted Shares Outstanding 30,997,020
Upcoming Milestones COMPANY
HIGHLIGHTS 2Q22 148009 Complete Phase 1b study in Parkinson's patients with mild to moderate disease Initiate dosing in Phase 2a study in early-stage Parkinson's patients Complete first of two animal model validation studies of
IkT-148009 in MSA Set-up EU/US sites for Phase 2 studies in MSA anticipated to commence in 3Q22 Meet with FDA to review Phase 2 and Phase 3 development plans 001Pro File IND and commence bioequivalence clinical studies Design and develop superiority
studies for IkT-001Pro relative to standard-of-care Identify and begin developing commercial partnership
ABOUT US Management Team with Deep
Experience in Drug Development and Commercialization 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
Biophysics at The Rockefeller University in New York City. Throughout his scientific career, Dr. Werner has been an innovator integrating chemistry, physics, and biology into a comprehensive approach to solving problems in medicine. Dr. Werner is
the author or co-author of more than 70 research articles, reviews, and book chapters and has given lectures on his research work throughout the world. Joseph Frattaroli, CPA Chief Financial Officer Mr. Frattaroli is a certified public accountant
with more than 15 years of experience in public company filings and compliance for Nasdaq and OTC Markets companies. Previously, he provided chief financial officer and consulting services for several emerging biopharmaceutical and medical device
companies, with responsibilities that included capital formation, deal structuring, and assisting private companies in their transition to becoming publicly traded SEC registrants. Executive C. Warren Olanow, MD, Interim Chief Medical Officer and
Chief Executive Officer of CLINTREX. Dr. Olanow is the former Henry P. and Georgette Goldschmidt Professor and Chairman of the Department of Neurology at the Mount Sinai School of Medicine Prior to joining Mount Sinai, he served on the faculties of
McGill University, Duke University, and the University of 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
Neurological Association. He has served on the executive committee of the Michael J. Fox Foundation Scientific Advisory Board, and he is the former Chairman of the Scientific Advisory Board of the Bachmann-Strauss Parkinson Foundation and of the