Inhibikase reports Q2 2026 results as Phase 3 PAH trial expands across 26 countries
The company said its IMPROVE-PAH study has cleared regulatory review in 26 countries and started dosing at 43 sites, while cash and the July $50 million raise are meant to fund the trial through Part B data.
Inhibikase Therapeutics reported second-quarter 2026 results on August 11, 2026, alongside updates on its Phase 3 program for IKT-001 in pulmonary arterial hypertension (PAH). CEO Mark Iwicki said the company had advanced its Phase 3 IMPROVE-PAH study with 26 country regulatory approvals together with the recent initiation of 43 clinical sites across a range of countries.1
The trial, formally named "IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH" (NCT07365332), received clearance to begin in the European Union earlier this year: in April 2026, Inhibikase received confirmation from the European Medicines Agency that the company is permitted to initiate its Phase 3 study in PAH.1 As of the release date, 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.1
The study design is a two-part adaptive trial. Part A is a double blind, placebo-controlled study in approximately 140 patients measuring change in Pulmonary Vascular Resistance at Week 24, while Part B follows immediately using the same format in approximately 346 patients, with a primary endpoint of change in 6-minute walk distance at Week 24.1
In July 2026, the company also announced an Orphan Drug Designation from the FDA for IKT-001, and closed a stock sale to RA Capital Management. In July 2026, 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.1
On the balance sheet, cash, cash equivalents and marketable securities were $159.0 million as of June 30, 2026.1 The company said the additional capital from the RA Capital financing, together with existing cash reserves, is expected to support operations through topline data readout in Part B of IMPROVE-PAH, assuming full and timely exercise of outstanding Series A and B Warrants.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.