1. Nature of Business

We are a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease (“PD”), disorders and other diseases of the Abelson Tyrosine Kinases. The Company’s multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program utilizing inhibitor, targets the treatment of Parkinson’s disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. In 2021, we commenced clinical development of which we believe can modify the course of Parkinson’s disease including its manifestation in the gastrointestinal tract, or GI. The FDA review of the Phase 1/1b data and the protocol for the Phase 2a three-month dosing study resulted in the FDA agreeing with the Company’s view that it was appropriate for the Phase 2a study to begin, prompting the Company to initiate the Phase 2a study, the 201 trial, at the end of May 2022. In October 2022, an IND to expand use of into the disease Multiple System Atrophy, or MSA, was filed with the FDA. On November 7, 2022, following review of the IND for as a treatment for MSA, the FDA notified the Company that it was placing the programs for Parkinson’s disease and MSA on clinical hold. The FDA lifted the full clinical hold in January 2023 for the Parkinson’s programs and in March 2023 on the MSA program, opening the IND for MSA. Twenty of thirty-five planned sites will be open as of March 28, 2023. The 201 in Parkinson’s trial will start screening patients for enrollment at 50 mg and 100 mg, with the 200 mg dose added back into the trial following submission of the safety and steady-state pharmacokinetic data of the 200 mg dose that was collected in March 2023. Once this data is submitted, the 200 mg dose will be added to the trial after 15 patients have been randomized to 50 mg, 100 mg or placebo groups. The FDA further requested the measurement of visual acuity and examination of the cornea and lens to complement the analysis of retina, macula and fundus that was already part of the ocular monitoring program in the 201 trial.

The Company is also developing platform technologies for alternate ways to deliver protein kinase inhibitors in patients. Our first example of this technology is a prodrug of the anticancer agent imatinib mesylate, to treat Stable Phase Chronic Myelogenous Leukemia Pursuant to its IND which was cleared by the FDA in August 2022, is being evaluated in a dose finding/dose equivalence study in up to 59 healthy volunteers (the 501 trial). The study is designed to evaluate the pharmacokinetics of imatinib delivered as and determine the dose of that can deliver the equivalent 400 mg imatinib, the dose for As of this writing, three of four dose escalation cohorts have completed the trial. Only four mild adverse events have been observed, none of clinical significance for has high oral bioavailability and a pharmacokinetic profile of delivered imatinib that closely matches the exposure of imatinib delivered as 400 mg imatinib mesylate. Following the 501 study, Inhibikase will confer with the FDA and seek agreement on the requirements for the NDA process following the proposed approval path for under the 505(b)(2) approval pathway. The Company plans to simultaneously pursue a superiority study comparing the selected doses of to 400 mg imatinib in patients using a novel, crossover-switching study.

For both and we have completed clinical batch manufacturing of a film-coated tablet formulation. The bioequivalence studies with have already implemented these tablets into the study. A pharmacokinetic bridging study with two different tablet formulations of is planned to be completed in 2023.

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