On November 15, 2021 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported financial results for the third quarter ended September 30, 2021 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 15, 2021, View Source [SID1234595608]).
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Key Business and Clinical Highlights
Dosed first patient in the Phase 1b clinical trial of IkT-148009: In October 2021 Inhibikase dosed the first patient in its Phase 1b clinical trial of IkT-148009, a randomized, placebo-controlled trial to evaluate the safety, tolerability, and pharmacokinetics of IkT-148009. The trial will enroll a total of 24 patients with Parkinson’s disease and also assess non-motor and motor function, gut motility, and measures of alpha-synuclein aggregate clearance, as exploratory endpoints. The Company expects to complete this study and, with the approval of the U.S. Food and Drug Administration (FDA), advance into a Phase 2a study in 2022.
Extended Phase 1 clinical trial of IkT-148009 to higher doses: In October 2021, Inhibikase expanded dosing of IkT-148009 in older and elderly healthy volunteers up to a single 250 mg dose to identify the maximum tolerated dose. This extension was based on the safety and tolerability profile observed in the initial dose cohorts of the Phase 1 study.
Submitted interim three-month results from chronic toxicology studies of IkT-148009 to FDA: In October 2021, Inhibikase reported that it had submitted interim three-month results from its ongoing chronic toxicology studies of IkT-148009 in rats and non-human primates to the FDA. Data indicated that the toxicology profile of IkT-148009 improves with extended daily oral dosing and supports evaluation in Parkinson’s patients for up to three months.
Received grant from U.S. National Institutes of Health to evaluate IkT-148009 for the treatment of Multiple System Atrophy: In September 2021, Inhibikase was awarded a research grant from the U.S. National Institute of Neurological Disease and Stroke (NINDS), an Institute of the National Institutes of Health (NIH), to evaluate the mechanism of the MSA disease process and the therapeutic potential of IkT-148009 in preclinical studies.
"Over the past quarter, we have worked diligently to advance our lead candidate, IkT-148009 in multiple indications. We dosed the first Parkinson’s patient in our Phase 1b study as well as submitted interim chronic toxicology data to the FDA to support extended dosing of IkT-148009. We were also pleased to receive a grant from the NIH to evaluate IkT-148009 in a novel preclinical model of MSA, a neurodegenerative disease that may benefit from c-Abl inhibition," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we look ahead, we expect to file our IND application for IkT-001Pro for the treatment of CML in the first quarter of 2022 as well as anticipate completing our Phase 1b study for Ikt-148009 in 2022."
Third Quarter Financial Results
Net Loss: Net loss for the quarter ended September 30, 2021, was $4.5 million, or $0.18 per share, compared to a net loss of $0.7 million, or $0.08 per share in the third quarter 2020.
R&D Expenses: Research and development expenses were $3.2 million for the quarter ended September 30, 2021 compared to $.1 million in the third quarter 2020. The increase was driven by a $0.3 million increase in grant related research expenditures and a $2.8 million increase in non-grant related research. The non-grant related research was expended primarily in connection with the Company’s Phase I Parkinson’s disease clinical trial.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2021 were $1.6 million compared to $0.6 million for the third quarter in 2020. The increase was the result of increased non-cash stock compensation expense of $0.1 million, increased director and officer’s liability insurance of $0.4 million related to the Company’s IPO in December 2020, increased legal fees, board fees, investor relation and consulting fees of $0.3 million relating to operating as a public company registrant since December 2020 and a net increase of $0.2 million for other normal operating expenses.
Cash Position: Cash and cash equivalents were $45 million as of September 30, 2021.