Inhibikase Activates 79 of 180 Planned IMPROVE-PAH Sites

The Tip Desk · November 10, 2026 · 3 min read

Cash, cash equivalents and marketable securities were $193.3 million after a $50 million RA Capital sale, and the company said that capital, assuming full and timely exercise of Series A and B warrants, will fund operations through the Part B topline readout.

Inhibikase Therapeutics (IKT), a clinical-stage pharmaceutical company developing IKT-001 for pulmonary arterial hypertension, said that as of November 2026 it had obtained regulatory approvals in 28 countries for its Phase 3 IMPROVE-PAH study and activated 79 of a planned 180 clinical sites.

The Wilmington, Delaware, company reported those site and country counts after 43 sites were initiated in the second quarter, when it had 26 country approvals. Chief Executive Officer Mark Iwicki said the company continued to advance the study during the third quarter and in recent weeks and that it looks forward to additional country and site activations over the coming months.

IMPROVE-PAH is a two-part adaptive Phase 3 trial. Part A is a double-blind, placebo-controlled study 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. An interim safety readout for Part A (n=50) is planned for the first half of 2027.

Net loss for the quarter ended September 30, 2026, was $20.5 million, or $0.10 a share, compared with a net loss of $11.9 million, or $0.13 a share, a year earlier. Research and development expenses were $15.0 million, compared with $7.6 million a year earlier. Selling, general and administrative expenses were $7.2 million, compared with $5.6 million a year earlier.

Cash, cash equivalents and marketable securities were $193.3 million as of September 30, 2026, up from $159.0 million as of June 30, 2026, after the company sold 25,000,000 shares to RA Capital Management through its at-the-market facility in July 2026 for gross proceeds of $50 million. Subsequently, 18,030,000 of those shares were exchanged for pre-funded warrants. In July 2026 the FDA’s Office of Orphan Products Development granted Orphan Drug Designation for IKT-001.

The company said it expects the additional capital from that financing, together with existing cash reserves, to support operations through the topline data readout in Part B of IMPROVE-PAH, assuming the full and timely exercise of the outstanding Series A and B warrants. As of September 30, 2026, there were 140.3 million shares of common stock and 60.6 million pre-funded warrants outstanding.

Inhibikase also said it has enhanced nonclinical work that it said has the potential to broaden the scientific rationale for IKT-001. Additional sotatercept-combination studies are focused on deepening the mechanistic and translational rationale, with results expected progressively starting in the first quarter of 2027. The company has begun regulatory filings to support combination therapy within Part B. Nonclinical activities exploring IKT-001 in HFpEF-associated pulmonary hypertension (Group 2) are expected to yield results during 2027, and studies in PH-ILD (Group 3) models are expected during late 2027 or early 2028.

In October 2026 the company appointed Scott M. Wasserman, MD, to its board. Dr. Wasserman is currently chief medical officer of Kailera Therapeutics.

The company is scheduled to present at the Jefferies Global Healthcare Conference in London on November 16 and at the 9th Annual Evercore Healthcare Conference in Coral Gables, Florida, with Mr. Iwicki participating in one-on-one investor meetings on December 1.