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Inhibikase Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Net loss for the quarter ended September 30, 2026, was $20.5 million ($0.10 per share), compared to a net loss of $11.9 million ($0.13 per share) in the same period in 2025.
    • Net loss for the nine months ended September 30, 2026, was $56.4 million ($0.31 per share), compared to a net loss of $35.5 million ($0.40 per share) for the nine months ended September 30, 2025.
    • Research and development expenses were $15.0 million for the quarter ended September 30, 2026, compared to $7.6 million for the quarter ended September 30, 2025.
    • Research and development expenses were $39.2 million for the nine months ended September 30, 2026, compared to $23.4 million for the nine months ended September 30, 2025.
    • Selling, general and administrative expenses were $7.2 million for the quarter ended September 30, 2026, compared to $5.6 million for the quarter ended September 30, 2025.
    • Selling, general and administrative expenses were $22.3 million for the nine months ended September 30, 2026, compared to $16.8 million for the nine months ended September 30, 2025.
    • Cash, cash equivalents, and marketable securities totaled $193.3 million as of September 30, 2026.
    • Net cash used in operating activities for the nine months ended September 30, 2026, was $41.9 million, compared to $20.3 million for the same period in 2025.
    • Net cash provided by financing activities for the nine months ended September 30, 2026, was $53.3 million, compared to net cash used of $0.1 million in 2025.
    • Stock-based compensation expense was $16.4 million for the nine months ended September 30, 2026, compared to $10.8 million for the nine months ended September 30, 2025.
  • Guidance and Future Outlook:

    • The Company expects its cash position, combined with the $50 million proceeds from the July 2026 financing, to support operations through the topline data readout in Part B of the IMPROVE-PAH study, assuming full and timely exercise of outstanding Series A and B Warrants.
    • An interim safety readout for Part A of the Phase 3 IMPROVE-PAH study (n=50) is planned for the first half of 2027.
    • Results for nonclinical studies evaluating IKT-001 in combination with sotatercept are expected progressively starting in the first quarter of 2027.
    • Results for nonclinical studies evaluating IKT-001 for Group 2 pulmonary hypertension (HFpEF-associated) are expected during 2027.
    • Results for nonclinical studies evaluating IKT-001 for Group 3 pulmonary hypertension (PH-ILD) are expected during late 2027 or early 2028.
  • Business Segments and Product Lines:

    • The Company is advancing its lead product candidate, IKT-001, a once-daily oral anti-proliferative prodrug of imatinib mesylate, for the treatment of Pulmonary Arterial Hypertension (PAH).
    • The global IMPROVE-PAH trial is a two-part adaptive Phase 3 study: Part A (double-blind, placebo-controlled) has a primary endpoint of change in Pulmonary Vascular Resistance (PVR) at Week 24 in approximately 140 patients; Part B seamlessly follows with a primary endpoint of change in 6-minute walk distance (6MWD) at Week 24 in approximately 346 patients.
    • As of November 2026, regulatory approvals for the IMPROVE-PAH study have been obtained in 28 countries, with 79 of a planned 180 clinical sites activated.
    • The Company has begun regulatory filings to support combination therapy with sotatercept within Part B of the ongoing Phase 3 program.
    • Nonclinical activities are underway to evaluate IKT-001 for potential benefits in myocardial fibrosis and diastolic function in HFpEF-associated pulmonary hypertension (Group 2).
    • Nonclinical activities are evaluating IKT-001 for potential therapeutic benefit in PH-ILD (Group 3) to reduce pulmonary vascular resistance and vascular remodeling.
  • Market and Competitive Landscape:

    • PAH is a progressive, life-threatening disease affecting approximately 50,000 Americans, characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance.
    • IKT-001 is an orphan indication; in July 2026, the FDA's Office of Orphan Products Development granted Orphan Drug Designation (ODD), providing potential incentives including tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and seven years of market exclusivity upon approval.
    • Imatinib, the parent compound of IKT-001, has been approved in the U.S. since 2001 for various cancers and blood disorders and has a well-characterized safety profile with over 20 years of clinical use.
  • Risks and Challenges:

    • Forward-looking statements regarding the advancement of the Phase 3 study, regulatory approvals, combination therapy evaluations, and nonclinical study results are subject to risks and uncertainties that could cause actual results to differ materially.
    • Key risks include the ability to execute the Phase 3 study to evaluate IKT-001 as a treatment for PAH.
    • The Company's cash runway and ability to fund operations are contingent on the full and timely exercise of outstanding Series A and B Warrants.
  • Management Commentary and Tone:

    • CEO Mark Iwicki stated the Company continued to advance the Phase 3 IMPROVE-PAH study, having obtained 28 country regulatory approvals and activated 79 clinical sites across a range of countries.
    • Management expressed confidence that the Company is well-positioned to advance IKT-001 toward its potential as the first once-daily oral anti-proliferative offering significant benefits to the PAH patient population.
    • The Company announced the appointment of Scott M. Wasserman, MD, to the Board of Directors in October 2026; Dr. Wasserman is the Chief Medical Officer of Kailera Therapeutics and a cardiologist with over two decades of experience.
  • Other Key Points:

    • In July 2026, the Company sold 25,000,000 shares of 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 were exchanged for pre-funded warrants to purchase shares of common stock.
    • As of September 30, 2026, there were 140.3 million shares of common stock and 60.6 million pre-funded warrants outstanding.
    • The Company participated in the Jefferies Global Healthcare Conference (November 16–19, 2026) and the 9th Annual Evercore Healthcare Conference (November 30–December 2, 2026).
    • Nine months ended September 30, 2025, R&D expenses included a non-cash write-off of in-process research and development of $7.4 million and $1.8 million of stock-based compensation expense associated with the acquisition of CorHepta in February 2025.
    • Nine months ended September 30, 2025, SG&A expenses included $1.0 million of severance expenses for former senior executives.
Company
INHIBIKASE THERAPEUTICS INC
Sector
Healthcare
Industry
Biotechnology