Inhibikase Therapeutics(IKT) - 2025 Q3 - Quarterly Report

Market Overview - The global Pulmonary Arterial Hypertension (PAH) market was valued at $7.66 billion in 2023, with an estimated compound annual growth rate of 3.3% through 2034[128]. - Sotatercept, launched in 2024, is generating approximately $1.4 billion in annualized sales, indicating a growing interest in anti-proliferative therapies for PAH[129]. Product Development - IKT-001, a prodrug of imatinib mesylate, is set to enter a Phase 2b study involving approximately 150 PAH patients, expected to initiate in Q4 2025[124][135]. - The FDA acknowledged the 505(b)(2) pathway as appropriate for IKT-001's approval, with a pre-NDA meeting confirming no additional clinical studies are needed[127]. - IKT-001 has established bioequivalence with a 300 mg dose to 230 mg of imatinib mesylate, and a 500 mg dose to 383 mg of imatinib mesylate, based on a study completed in 2023[126]. - The primary efficacy endpoint for the IMPROVE-PAH study will be the change in pulmonary vascular resistance (PVR) at Week 26[135]. - The company plans to apply for Orphan Drug Designation for IKT-001 once pre-clinical studies are complete, enhancing its market exclusivity prospects[133]. Financial Performance - Research and development expenses increased by $3,459,824 or 82.6% to $7,649,697 for the three months ended September 30, 2025, compared to $4,189,873 in the prior year[151]. - Selling, general and administrative expenses rose by $3,973,900 or 242.7% to $5,611,503 for the same period, up from $1,637,603[152]. - Net loss for the three months ended September 30, 2025, was $11,930,280, representing an increase of $6,152,214 or 106.5% from the previous year[150]. - Research and development expenses for the nine months ended September 30, 2025, totaled $23,434,243, an increase of $13,417,261 or 133.9% from $10,016,982 in 2024[157]. - Selling, general and administrative expenses for the nine months ended September 30, 2025, increased by $11,137,139 or 197.3% to $16,780,525 from $5,643,386[158]. - Interest income surged by $2,401,060 or 879.3% to $2,674,119 for the nine months ended September 30, 2025, compared to $273,059 in the prior year[160]. - The company had cash, cash equivalents, and marketable securities of $77.3 million as of September 30, 2025[163]. - The accumulated deficit reached $129.9 million as of September 30, 2025, with expectations of continued significant losses in the future[167]. - The company anticipates needing substantial additional funding to support ongoing operations and product development[165]. - The company has not generated any revenue from product sales and does not expect to do so until regulatory approval is obtained for its product candidates[165]. Cash Flow and Financing - Net cash used in operating activities for the nine months ended September 30, 2025, totaled $20,270,491, compared to $13,802,492 for the same period in 2024, reflecting a significant increase in cash outflow[172][174]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $2,151,977, up from $1,757,524 in 2024, primarily due to $41.6 million from the maturity of marketable securities[175][176]. - Net cash used in financing activities for the nine months ended September 30, 2025, was $102,359, a decrease from $3,793,209 in 2024, indicating reduced financing activity[177][178]. Merger and Acquisition - The company entered into a merger agreement with CorHepta Pharmaceuticals, resulting in the issuance of 4,979,101 shares of common stock, with contingent consideration based on performance milestones[188][189]. - The fair value of contingent consideration recognized at acquisition was adjusted, resulting in a change in fair value of $2,016,111 for the nine months ended September 30, 2025[190]. - The acquired in-process research and development asset of $7,357,294 was written off as research and development expense immediately following the acquisition[191]. - The company has not recorded a liability for contingent consideration as the achievement of performance milestones is not currently deemed probable[182][190]. Clinical Trial Costs - The total remaining contract costs for a clinical trial supply agreement as of September 30, 2025, were approximately $6.3 million, with an estimated performance period through 2029[180]. - Research and development expenses are recorded as incurred, with significant costs associated with external service providers and clinical studies[184][185].