On August 11, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing IKT-001, a novel once-daily oral anti-proliferative for Pulmonary Arterial Hypertension ("PAH"), reported financial results for the quarter ended June 30, 2026, and highlighted recent developments.

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"During our second quarter and in recent weeks we continued to advance our Phase 3 IMPROVE-PAH study with 26 country regulatory approvals together with the recent initiation of 43 clinical sites across a range of countries," said Mark Iwicki, Chief Executive Officer of Inhibikase. "Also, during the quarter, favorable results of pre-clinical and Phase 1 studies of IKT-001 were presented at the American Thoracic Society International Conference, with data demonstrating improvements in pulmonary vascular and hemodynamic markers of PAH and lower potential for GI toxicity compared to imatinib mesylate. Together with the recent grant of Orphan Drug Designation from the U.S. FDA and the $50 million proceeds from the sale of shares to RA Capital, Inhibikase is well-positioned to advance IKT-001 toward its potential as the first once-daily oral anti-proliferative offering significant potential benefits to the PAH patient population."

Recent Developments

In April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted to initiate its 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). Globally, regulatory approvals for the Phase 3 study have been obtained in 26 countries with 3 additional country approvals pending and 4 additional country regulatory submissions planned.

The global IMPROVE-PAH trial is a two-part adaptive Phase 3 study. 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 enrollment of the last patient in Part A and adopts an identical format to Part A except the primary endpoint of Part B is change in 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.

In July 2026, the Company sold 25,000,000 shares of the Company’s common stock to RA Capital Management through its at-the-market ("ATM") facility for gross proceeds of $50 million. Subsequently, in July 2026, 18,030,000 of these shares of common stock were exchanged for pre-funded warrants to purchase shares of common stock.

In July 2026, the FDA’s Office of Orphan Products Development granted Orphan Drug Designation ("ODD") for IKT-001. ODD provides potential development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential for seven years of market exclusivity upon regulatory approval.

Presentations

In May 2026, pre-clinical and Phase 1 data for IKT-001 were presented at the American Thoracic Society ("ATS") International Conference in Orlando, Florida. These presentations included data demonstrating the following:

The potential for IKT-001 to have an improved gastro-intestinal ("GI") side-effect profile, including gastric emptying benefits and reduced impairment of intestinal motility compared to imatinib mesylate. IKT-001 remains intact in the stomach and the intestine and is not converted to imatinib until it reaches the blood, with in vitro pharmacology studies demonstrating an 18-fold decrease in c-Kit inhibition which has been implicated in the GI side-effects of imatinib.

Single doses of IKT-001 resulted in rapid and dose proportional exposure of circulating imatinib, which were well tolerated over a 300-800 mg range with no indication of dose-dependent GI toxicities.

Financial Results

Cash Position: As of June 30, 2026, cash, cash equivalents and marketable securities were $159.0 million. Subsequent to the close of the quarter the Company announced that it had sold 25,000,000 shares of the Company’s common stock to RA Capital Management through its ATM facility for gross proceeds of $50 million. The Company expects that the additional capital raised through this financing, together with existing cash reserves, will support operations through topline data readout in Part B of the ongoing global Phase 3 IMPROVE-PAH clinical study, assuming the full and timely exercise of the outstanding Series A and B Warrants.

As of June 30, 2026, there were 132.0 million shares of common stock and 42.5 million pre-funded warrants outstanding.

Net Loss: Net loss for the quarter ended June 30, 2026, was $19.6 million, or $0.11 per share, compared to a net loss of $9.9 million, or $0.11 per share in the quarter ended June 30, 2025. Net loss for the six months ended June 30, 2026, was $36.0 million, or $0.21 per share, compared to a net loss of $23.6 million, or $0.26 per share, for the six months ended June 30, 2025.

R&D Expenses: Research and development expenses were $13.4 million for the quarter ended June 30, 2026, compared to $5.3 million for the quarter ended June 30, 2025. Research and development expenses were $24.2 million for the six months ended June 30, 2026, compared to $15.8 million for the six months ended June 30, 2025.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2026 were $7.7 million, compared to $5.9 million for the quarter ended June 30, 2025. Selling, general and administrative expenses for the six months ended June 30, 2026 were $15.0 million, compared to $11.2 million for the six months ended June 30, 2025, which included $1.0 million of severance expenses for prior senior executives of the Company.

(Press release, Inhibikase Therapeutics, AUG 11, 2026, View Source [SID1234669947])