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Disease-Modifying Therapeutics for Neurodegenerative Disease & Cancer Inhibikase.com : IKT
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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 na ve 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
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 R = 0.9977 6000 180000 R = 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 na ve/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) 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) 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
Selected Stock and Financial Data In Inh hiib biik ka as se e.c .co om
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