On May 14, 2025 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company innovating small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension ("PAH"), reported financial results for the quarter ended March 31, 2025 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 14, 2025, View Source [SID1234653061]).

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"During our first quarter of 2025, we continued to build out our senior leadership team and key infrastructure areas to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With our core team now in place, and with ongoing refining of our study protocol with key opinion leaders, IKT is well placed to initiate our Phase 2b clinical study of IKT-001 in PAH in the second half of 2025." The IMPRES Phase 3 study of imatinib mesylate previously demonstrated improved exercise capacity and hemodynamics in patients with advanced PAH. We continue to believe that systemic exposure of imatinib with IKT-001 can be well tolerated and provide strong efficacy to patients suffering from PAH.

Recent Developments:

Announced the appointments of Mark Iwicki as Chief Executive Officer, Chris Cabell, M.D., M.H.S, FACC, as President and Head of Research & Development, and John Adams, Ph.D., as Chief Scientific Officer, and David McIntyre as Chief Financial Officer.
Advancement of IKT-001 as a therapy in PAH:
The Company has continued to meet with key opinion leaders and other experts in PAH with a view to refining the Company’s proposed study design for the forthcoming Phase 2b clinical study of IKT-001 in PAH. The Company expects to finalize the study design in the ensuing weeks.
The Company previously received its "Study May Proceed" letter for the Phase 2b trial in September 2024, noting that the active ingredient in IKT-001, imatinib, has previously been shown to have a meaningful impact on key efficacy parameters such as 6 minute walk distance in advanced PAH.
First Quarter 2025 Financial Results

Net Loss: Net loss for the quarter ended March 31, 2025, was $13.7 million, or $0.15 per share, compared to a net loss of $4.6 million, or $0.73 per share in the quarter ended March 31, 2024.

R&D Expenses: Research and development expenses were $10.5 million for the quarter ended March 31, 2025, compared to $2.8 million for the quarter ended March 31, 2024. This includes a non-cash charge for in-process research and development expense of $7.4 million associated with the Company’s acquisition of CorHepta, which was effective on February 21, 2025.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2025 were $5.2 million compared to $2.0 million for the quarter ended March 31, 2024.

Cash Position: Cash, cash equivalents and marketable securities were $93.2 million as of March 31, 2025.