Inhibikase Loss Widens as Phase 3 PAH Trial Expands

Medical research
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WILMINGTON, DE— Inhibikase Therapeutics, Inc. (Nasdaq: IKT) nearly doubled its second-quarter net loss as spending increased on its Phase 3 pulmonary arterial hypertension program, while a subsequent $50 million stock sale bolstered the drug developer’s resources for the global trial.

The clinical-stage pharmaceutical company reported a net loss of $19.6 million, or $0.11 per share, for the quarter ended June 30, compared with $9.9 million, or $0.11 per share, a year earlier.

Research and development expenses climbed to $13.4 million from $5.3 million. Selling, general and administrative expenses increased to $7.7 million from $5.9 million.

For the first six months of 2026, Inhibikase recorded a $36 million net loss, or $0.21 per share, compared with $23.6 million, or $0.26 per share, in the year-earlier period. Six-month R&D spending rose to $24.2 million from $15.8 million, while SG&A expenses increased to $15 million from $11.2 million.

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Inhibikase ended June with $159 million in cash, cash equivalents and marketable securities. In July, RA Capital Management purchased 25 million common shares through the company’s at-the-market facility for gross proceeds of $50 million.

Later that month, 18.03 million of those shares were exchanged for pre-funded warrants to purchase common stock. Inhibikase had 132 million common shares and 42.5 million pre-funded warrants outstanding as of June 30.

The company expects the new capital and existing reserves to fund operations through the topline data readout from Part B of its Phase 3 IMPROVE-PAH study, assuming full and timely exercise of outstanding Series A and B warrants.

That trial is evaluating IKT-001, Inhibikase’s once-daily oral anti-proliferative candidate for pulmonary arterial hypertension. Regulatory approvals have been obtained in 26 countries, with three additional approvals pending and submissions planned in four more countries.

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Inhibikase reported that 43 clinical sites have recently been initiated. The European Medicines Agency cleared the company in April to begin the Phase 3 study in Europe.

IMPROVE-PAH is structured as a two-part adaptive trial. Part A is a double-blind, placebo-controlled study of approximately 140 patients, with change in pulmonary vascular resistance at 24 weeks as its primary endpoint.

Part B is designed to begin after enrollment of the final Part A patient and use a similar format, but will evaluate change in six-minute walk distance at 24 weeks as the primary endpoint in approximately 346 patients.

The U.S. Food and Drug Administration in July granted IKT-001 Orphan Drug Designation, which can provide development incentives including certain clinical-trial tax credits, exemption from some FDA user fees and potentially seven years of U.S. market exclusivity if the drug ultimately receives regulatory approval.

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Inhibikase also presented preclinical and Phase 1 findings on IKT-001 at the American Thoracic Society International Conference in May. The company reported data indicating potentially lower gastrointestinal toxicity than imatinib mesylate, including an 18-fold reduction in c-Kit inhibition in in vitro pharmacology studies.

Single doses of IKT-001 produced rapid, dose-proportional exposure to circulating imatinib and were well tolerated across a 300-milligram to 800-milligram range, with no indication of dose-dependent gastrointestinal toxicities, according to the company.

Chief Executive Officer Mark Iwicki characterized the regulatory expansion, clinical-site activation, orphan designation and financing as positioning Inhibikase to continue advancing IKT-001 through the Phase 3 program.

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