On March 31 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the full year ended December 31, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAR 31, 2022, View Source [SID1234611296]).
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"2021 was an important year for Inhibikase as we advanced our lead program IkT-148009 for Parkinson’s disease into the clinic, continued to develop our early-stage pipeline programs and strengthened our balance sheet to support our development efforts well into 2023," commented Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Just recently, we presented results from our Phase 1 and 1b study of IkT-148009 in patients with mild to moderately advanced Parkinson’s disease at the annual AD/PD meeting. We believe these data continue to validate the safety and therapeutic potential of IkT-148009. As we look ahead, we hope to share more about our development strategy for this program including the upcoming Phase 2a study at our upcoming virtual KOL investor event on April 20th. Looking to our earlier programs, we are also continuing to advance IkT-148009 in animal models of Multiple Systems Atrophy (MSA), as well as plan to submit our IND application for IkT-001Pro, both in the second quarter. We view 2022 as a year of execution across our pipeline and look forward to providing updates throughout the year as we seek to improve the lives of patients suffering from a devastating neurodegenerative disease."
Recent Developments and Upcoming Milestones:
Phase 1b clinical trial of IkT-148009: The Phase 1b study is a 3:1 randomized, placebo-controlled dose escalation trial evaluating the safety, tolerability, and pharmacokinetics of seven-day dosing of IkT-148009 at three escalating dose levels. The study is also assessing motor and non-motor function, gut motility, and measures of alpha-synuclein aggregate clearance as exploratory endpoints. In March, the Company presented data from the first cohort at the Alzheimer’s & Parkinson’s Diseases Conference (AD/PD). Data demonstrated that the safety and tolerability profile in patients closely matched that of older healthy volunteers. Pharmacokinetics of IkT-148009 in volunteers and subjects was also similar, indicating that IkT-148009 pharmacology is consistent across the patient groups and penetrates the Central Nervous System. The Company expects to complete dosing of the Phase 1b study in the second quarter of 2022 and present full data at a medical meeting later this year.
Phase 1 dose escalation of IkT-148009 in older and elderly healthy volunteers: Inhibikase continues to evaluate IkT-148009 in older and elderly healthy volunteers as part of the Phase 1 study. The Company has completed dose escalation studies through 325 mg. To date, no clinically significant adverse events have been observed at any dose.
Phase 2a clinical study for IkT-148009 in patients with Parkinson’s Disease: Inhibikase expects to dose the first patient in a Phase 2a study of IkT-148009 in untreated Parkinson’s Disease in the second quarter of 2022, subject to agreements with the FDA. The 3:1 randomized, double-blind, twelve-week dosing trial will evaluate the safety and tolerability of three doses of IkT-148009 in up to 120 patients diagnosed with Parkinson’s disease who have not yet progressed to the need for symptomatic therapy. The trial will also measure motor and non-motor function inside and outside of the brain as secondary endpoints and evaluate whether treatment with IkT-148009 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints.
Investigational New Drug application (IND) for IkT-001Pro for stable-phase Chronic Myelogenous Leukemia (CML): IkT-001Pro is the Company’s prodrug formulation of Imatinib mesylate, designed as a potentially safer, better tolerated treatment for Imatinib-sensitive cancers such as stable-phase Chronic Myeloid Leukemia (CML). The Company is completing clinical batch manufacturing of pill formulated IkT-001Pro and conducting required stability studies and expects to submit the IND for IkT-001Pro in the second quarter of 2022. The Company expects to commence bioequivalence studies in accordance with the 505(b)(2) regulatory pathway agreements with the FDA.
Preclinical studies evaluating IkT-148009 in animal models of Multiple System Atrophy (MSA) in preparation for Phase 2 clinical studies: Inhibikase expects to report preclinical data studying IkT-148009 in at least one of two animal models of MSA prior to dosing of MSA patients. The studies are evaluating whether inhibition of the Abelson Tyrosine Kinase, or c-Abl, could have a therapeutic benefit in MSA. The potential role of c-Abl in the disease process was highlighted in the Company’s recent publication published in the peer reviewed journal Neurobiology of Disease[1]. Depending on the preclinical results in animal models of MSA and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, Inhibikase may advance IkT-148009 into a Phase 2a clinical study in the third quarter of 2022.
Upcoming Events:
Virtual KOL Investor Event
Date: April 20, 2022
Time: 10:00am ET
Registration Link: View Source
Inhibikase’s executive leadership team and featured Key Opinion Leaders will host a virtual presentation highlighting the Company’s recent clinical progress including a review of the recently reported Phase 1 data for its lead asset, IkT-148009 as well as an overview of the upcoming Phase 2 program. Additional presentations will highlight the current unmet need and competitive landscape in Parkinson’s disease.
Full Year 2021 Financial Results
Grant Revenue: Grant revenue was $3.1 million for the year ended December 31, 2021 compared to $0.7 million in the prior year. The increase was driven by increased grant research activity during 2021 compared to 2020. During 2020, the Company’s focus was shifted toward advancing its Phase I clinical trials which did not result in grant revenue. The Company utilized its working capital and personnel resources in 2021 to carry on its Phase I clinical trial in addition to its grant research activity.
R&D Expenses: Research and development expenses were $11.4 million for the year ended December 31, 2021 compared to $0.9 million in the year ended December 31, 2020. The increase was primarily due to a full year of increased activity in our Parkinson’s disease Phase I clinical trial.
SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2021 were $6.5 million compared to $2.6 million for the year ended December 31, 2020. The increase was primarily due to increased liability insurance, legal and accounting fees, board costs, investor relations and consulting fees associated with operating for the first full year as a public company.
Net Loss: Net loss for the year ended December 31, 2021 was $14.8 million, or $0.81 per share, compared to a net loss of $2.8 million, or $0.35 per share in the year ended December 31, 2020.
Cash Position: Cash and cash equivalents were $40.8 million as of December 31, 2021. The Company expects that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.