Inhibikase Initiates Two-Part Phase 3 PAH Trial, Holds $178.8M Cash
Inhibikase initiated its global pivotal two-part Phase 3 IMPROVE-PAH trial for IKT-001 in Pulmonary Arterial Hypertension, enrolling 140 patients for PVR and planning 346 patients for 6-minute walk distance after FDA Type C Written Response. The company ended 2025 with $178.8 million cash and reported a $48.3 million net loss.
1. Full Year 2025 Financial Results
Inhibikase ended 2025 with $178.8 million in cash and equivalents following a $115 million November public offering. Net loss widened to $48.3 million ($0.49 per share) as R&D expenses rose to $29.8 million and SG&A climbed to $23.6 million.
2. Global Adaptive Phase 3 Trial Launch
The company initiated the two-part adaptive Phase 3 IMPROVE-PAH trial in Pulmonary Arterial Hypertension, enrolling 140 patients in Part A to assess Pulmonary Vascular Resistance at Week 24 and planning 346 patients in Part B to measure 6-minute walk distance at Week 24 under a double-blind, placebo-controlled design.
3. Regulatory Approvals and Orphan Drug Plans
Regulatory submissions for IMPROVE-PAH have been filed in over 20 countries and the first U.S. clinical sites are active after FDA Type C Written Response. Inhibikase secured FAST-EU pilot acceptance for potential 70-day EU trial authorization and completed preclinical studies to support Orphan Drug Designation, with data due at a May conference.