Inhibikase Starts 43 Sites After 26-Country Trial Approvals
Cash, cash equivalents and marketable securities were $159.0 million at June 30, 2026, after a $50 million RA Capital sale in July.
Inhibikase Therapeutics (IKT), a clinical-stage pharmaceutical company developing IKT-001 for pulmonary arterial hypertension, obtained country regulatory approvals for its Phase 3 IMPROVE-PAH study in 26 countries and initiated 43 clinical sites during the second quarter, after the first U.S. sites were activated and the first U.S. patient enrolled in April.
Chief Executive Officer Mark Iwicki said the company continued to advance the registrational trial with those approvals and site starts. Three additional country approvals were pending and four more regulatory submissions were planned.
IMPROVE-PAH is a two-part adaptive Phase 3 study. Part A is a double-blind, placebo-controlled trial in approximately 140 patients with a primary endpoint of change in pulmonary vascular resistance at Week 24. Part B begins after the last Part A patient is enrolled and uses the same format except that the primary endpoint is change in 6-minute walk distance at Week 24 in approximately 346 patients. The study is expected to run at about 180 sites worldwide.
In April the European Medicines Agency confirmed the company could initiate the study in PAH. In May, preclinical and Phase 1 data for IKT-001 were presented at the American Thoracic Society International Conference. The data showed improvements in pulmonary vascular and hemodynamic markers of PAH and a lower potential for gastrointestinal toxicity compared with imatinib mesylate. In vitro pharmacology showed an 18-fold decrease in c-Kit inhibition, which has been implicated in imatinib’s GI side effects. Single doses produced rapid, dose-proportional circulating imatinib exposure that was well tolerated over a 300–800 mg range, with no indication of dose-dependent GI toxicities.
In July the FDA’s Office of Orphan Products Development granted Orphan Drug Designation for IKT-001 after an application submitted in April. ODD provides potential development incentives, including tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon approval.
Net loss for the quarter ended June 30, 2026, was $19.6 million, or $0.11 a share, compared with a net loss of $9.9 million, or $0.11 a share, a year earlier. Research and development expenses were $13.4 million. Selling, general and administrative expenses were $7.7 million.
Cash, cash equivalents and marketable securities were $159.0 million as of June 30, 2026, down from $170.4 million at March 31, 2026. Cash and cash equivalents were $31.2 million and marketable securities were $127.8 million.
In July the company sold 25,000,000 shares of common stock to RA Capital Management through its at-the-market facility for gross proceeds of $50 million. Subsequently, 18,030,000 of those shares were exchanged for pre-funded warrants. As of June 30, 2026, there were 132.0 million shares of common stock and 42.5 million pre-funded warrants outstanding.
The additional capital raised through that financing, together with existing cash reserves, is expected to support operations through topline data readout in Part B of IMPROVE-PAH, assuming the full and timely exercise of outstanding Series A and B warrants.
IKT-001 is a prodrug of imatinib mesylate. PAH affects approximately 50,000 Americans.