On May 12, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended March 31, 2026, and highlighted recent developments.
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"We were excited to enroll the first patient in our registrational IMPROVE-PAH study last month, and are very pleased with our early progress obtaining country regulatory approvals to support initiation of clinical sites, including being one of the first companies to successfully take advantage of the new European Medicines Agency FAST-EU (Facilitating and Accelerating Strategic Trials in the European Union) initiative to accelerate multinational clinical trials," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With the recent approvals obtained in the first 16 countries worldwide, Inhibikase is well-positioned to initiate clinical site activations and seek to advance enrollment of IMPROVE-PAH. Later this week, we also look forward to the first of two new presentations of Phase 1 and pre-clinical studies of IKT-001 at the American Thoracic Society International Conference, to be held in Orlando, Florida."
Recent Developments
In late April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted to initiate our Phase 3 study in PAH, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), in 12 countries in the European Union. This approval brings the total country approvals for IMPROVE-PAH to 16, including the United States, Canada, New Zealand and Argentina, and further enables the Company to leverage this approval to seek the approval of an additional 3 countries in the European Union over the coming months to supplement our ongoing broader global country regulatory approval efforts.
The global IMPROVE-PAH study is a two-part adaptive Phase 3 study incorporating an initial 12-week dose titration phase designed to enable patients to get to the highest tolerable dose of IKT-001.
Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance ("PVR") at Week 24.
Part B of IMPROVE-PAH seamlessly begins following the last patient in Part A being enrolled and adopts an identical format to Part A, except the primary endpoint will be change in 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.
In addition to the titration benefits mentioned above, IMPROVE-PAH has the advantage of uninterrupted enrollment between Part A and Part B, together with the opportunity to undertake a sample size re-estimation for Part B based on Part A findings, if necessary.
In April 2026, Inhibikase announced that IMPROVE-PAH has been initiated with the recent activation of our first clinical sites in the United States, together with the enrollment of the first patient in the United States. Following the recent country approvals mentioned above, efforts to initiate clinical sites outside of the United States are now advancing.
In April 2026, Inhibikase submitted an Orphan Drug Designation ("ODD") application to the U.S. Food and Drug Administration for IKT-001 for treatment of PAH recognizing that PAH is a high unmet medical need impacting approximately 50,000 Americans.
Upcoming Presentations
IKT-001 pre-clinical and Phase 1 data will be featured into two presentations at the American Thoracic Society (ATS) International Conference in Orlando, Florida on May 17 and 20, 2026:
Safety, Tolerability, and Pharmacokinetics of IKT-001, a Novel Prodrug of Imatinib, in Healthy Volunteers, on May 17, 2026
In Vitro Pharmacology and Preclinical Efficacy of IKT-001 in Pulmonary Arterial Hypertension, on May 20, 2026.
Financial Results
Cash Position: As of March 31, 2026, cash, cash equivalents and marketable securities were $170.4 million.
Net Loss: Net loss for the quarter ended March 31, 2026, was $16.4 million, or $0.10 per share, compared to a net loss of $13.7 million, or $0.15 per share in the quarter ended March 31, 2025.
R&D Expenses: Research and development expenses were $10.8 million for the quarter ended March 31, 2026, compared to $10.5 million for the quarter ended March 31, 2025, which included a one-time (non-cash) charge of $7.4 million for the acquired IPR&D related to the CorHepta acquisition.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2026 were $7.4 million, compared to $5.2 million for the quarter ended March 31, 2025.
(Press release, Inhibikase Therapeutics, MAY 12, 2026, View Source [SID1234665541])