“We were excited to enroll the first patient in our registrational IMPROVE-PAH study last month, and are very pleased with our early progress obtaining country regulatory approvals to support initiation of clinical sites, including being one of the first companies to successfully take advantage of the new European Medicines Agency FAST-EU (Facilitating and Accelerating Strategic Trials in the
Recent Developments
- In late
April 2026 ,Inhibikase received confirmation from theEuropean Medicines Agency that the Company is permitted to initiate our Phase 3 study in PAH, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), in 12 countries in theEuropean Union . This approval brings the total country approvals for IMPROVE-PAH to 16, includingthe United States ,Canada ,New Zealand andArgentina , and further enables the Company to leverage this approval to seek the approval of an additional 3 countries in theEuropean Union over the coming months to supplement our ongoing broader global country regulatory approval efforts.
- The global IMPROVE-PAH study is a two-part adaptive Phase 3 study incorporating an initial 12-week dose titration phase designed to enable patients to get to the highest tolerable dose of IKT-001.
- Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance (“PVR”) at Week 24.
- Part B of IMPROVE-PAH seamlessly begins following the last patient in Part A being enrolled and adopts an identical format to Part A, except the primary endpoint will be change in 6-minute walk distance (“6MWD”) at Week 24 in approximately 346 patients.
- In addition to the titration benefits mentioned above, IMPROVE-PAH has the advantage of uninterrupted enrollment between Part A and Part B, together with the opportunity to undertake a sample size re-estimation for Part B based on Part A findings, if necessary.
- Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of change in Pulmonary Vascular Resistance (“PVR”) at Week 24.
- The global IMPROVE-PAH study is a two-part adaptive Phase 3 study incorporating an initial 12-week dose titration phase designed to enable patients to get to the highest tolerable dose of IKT-001.
- In
April 2026 ,Inhibikase announced that IMPROVE-PAH has been initiated with the recent activation of our first clinical sites inthe United States , together with the enrollment of the first patient in the United States. Following the recent country approvals mentioned above, efforts to initiate clinical sites outside ofthe United States are now advancing. - In
April 2026 ,Inhibikase submitted an Orphan Drug Designation (“ODD”) application to theU.S. Food and Drug Administration for IKT-001 for treatment of PAH recognizing that PAH is a high unmet medical need impacting approximately 50,000 Americans.
Upcoming Presentations
- IKT-001 pre-clinical and Phase 1 data will be featured into two presentations at the
American Thoracic Society (ATS) International Conference inOrlando, Florida onMay 17 and 20, 2026:
- Safety, Tolerability, and Pharmacokinetics of IKT-001, a Novel Prodrug of Imatinib, in
Healthy Volunteers , onMay 17, 2026 - In Vitro Pharmacology and Preclinical Efficacy of IKT-001 in Pulmonary Arterial Hypertension, on
May 20, 2026 .
- Safety, Tolerability, and Pharmacokinetics of IKT-001, a Novel Prodrug of Imatinib, in
Financial Results
Cash Position: As of
Net Loss: Net loss for the quarter ended
R&D Expenses: Research and development expenses were
SG&A Expenses: Selling, general and administrative expenses for the quarter ended
About
Social Media Disclaimer
Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases,
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” “anticipates,” “plans,” or similar expressions or the negative of these terms and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements that express the Company’s intentions, beliefs, expectations, strategies, predictions or any other statements related to the potential effects of IKT-001, the advancement of the Company’s global pivotal Phase 3 clinical study of IKT-001 in PAH, including the timing, design, and conduct of the IMPROVE-PAH study and related regulatory submissions, the Company’s ability to obtain additional regulatory approvals for the IMPROVE-PAH study, the Company’s beliefs regarding the potential advantages of the Phase 3 clinical study of IKT-001, or future events or conditions. These forward-looking statements are based on Inhibikase’s current expectations and assumptions. Such statements are subject to certain risks and uncertainties, which could cause Inhibikase’s actual results to differ materially from those anticipated by the forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to execute a Phase 3 study to evaluate IKT-001 as a treatment for PAH, as well as such other factors that are included in our periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. Any forward-looking statement in this release speaks only as of the date of this release.
Contacts:
Investor Relations:
mmoyer@lifesciadvisors.com
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Condensed Consolidated Balance Sheets (Unaudited) | ||||||||
2026 | 2025 | |||||||
| Assets | ? | |||||||
| Current assets: | ? | |||||||
| Cash and cash equivalents | $ | 49,573,510 | $ | 139,220,208 | ||||
| Marketable securities | 120,795,235 | 39,543,820 | ||||||
| Prepaid research and development | 514,910 | 1,001,993 | ||||||
| Prepaid expenses and other current assets | 1,292,813 | 343,374 | ||||||
| Total current assets | 172,176,468 | 180,109,395 | ||||||
| Prepaid research and development, noncurrent | 1,000,000 | 1,000,000 | ||||||
| Other assets | 155,759 | 95,121 | ||||||
| Total assets | $ | 173,332,227 | $ | 181,204,516 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,587,305 | $ | 1,158,054 | ||||
| Accrued expenses and other current liabilities | 4,124,654 | 4,081,282 | ||||||
| Contingent consideration liability | — | 3,061,501 | ||||||
| Total current liabilities | 5,711,959 | 8,300,837 | ||||||
| Total liabilities | 5,711,959 | 8,300,837 | ||||||
| Commitments and contingencies (see Note 16) | ||||||||
| Stockholders’ equity: | ? | ? | ||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 132,032 | 131,691 | ||||||
| Additional paid-in capital | 326,575,169 | 315,429,986 | ||||||
| Accumulated other comprehensive income (loss) | (26,293 | ) | 21,802 | |||||
| Accumulated deficit | (159,060,640 | ) | (142,679,800 | ) | ||||
| Total stockholders' equity | 167,620,268 | 172,903,679 | ||||||
| Total liabilities and stockholders’ equity | $ | 173,332,227 | $ | 181,204,516 | ||||
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) | ||||||||
| Three months ended | ||||||||
| 2026 | 2025 | |||||||
| Costs and expenses: | ||||||||
| Research and development | $ | 10,839,150 | $ | 10,513,579 | ||||
| Selling, general and administrative | 7,376,123 | 5,249,291 | ||||||
| Change in fair value contingent consideration | (373,354 | ) | (1,164,864 | ) | ||||
| Total costs and expenses | 17,841,919 | 14,598,006 | ||||||
| Loss from operations | (17,841,919 | ) | (14,598,006 | ) | ||||
| Other income | 1,461,079 | 919,271 | ||||||
| Net loss | (16,380,840 | ) | (13,678,735 | ) | ||||
| Other comprehensive income (loss), net of tax | ||||||||
| Unrealized gain (loss) on marketable securities | (48,095 | ) | 36,281 | |||||
| Comprehensive loss | $ | (16,428,935 | ) | $ | (13,642,454 | ) | ||
| Net loss per share?–?basic and diluted | $ | (0.10 | ) | $ | (0.15 | ) | ||
| Weighted-average number of shares?–?basic and diluted | 172,306,932 | 89,537,171 | ||||||
Condensed Consolidated Statements of Cash Flows (Unaudited) | ||||||||
| Three months ended | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (16,380,840 | ) | $ | (13,678,735 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | — | 12,654 | ||||||
| Stock-based compensation expense | 5,559,766 | 2,042,196 | ||||||
| Write-off of in-process research and development | — | 7,357,294 | ||||||
| Change in fair value contingent consideration | (373,354 | ) | (1,164,864 | ) | ||||
| Non-cash accretion on marketable securities | (814,923 | ) | — | |||||
| Changes in operating assets and liabilities: | ||||||||
| Operating lease right-of-use assets | — | 32,718 | ||||||
| Prepaid expenses and other current assets | (949,439 | ) | (211,924 | ) | ||||
| Prepaid research and development | 487,083 | 28,833 | ||||||
| Other assets | (60,638 | ) | — | |||||
| Accounts payable | 429,251 | 680,824 | ||||||
| Operating lease liabilities | — | (35,745 | ) | |||||
| Accrued expenses and other current liabilities | 43,372 | 833,219 | ||||||
| Net cash used in operating activities | (12,059,722 | ) | (4,103,530 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of equipment and improvements | — | (13,399 | ) | |||||
| Purchases of investments - marketable securities | (90,584,587 | ) | — | |||||
| Maturities of investments - marketable securities | 10,100,000 | 21,506,365 | ||||||
| Acquired in-process research and development | — | (438,624 | ) | |||||
| Net cash provided by (used in) investing activities | (80,484,587 | ) | 21,054,342 | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock, pre-funded warrants and warrants, net of issuance costs | 2,897,611 | — | ||||||
| Net cash provided by financing activities | 2,897,611 | — | ||||||
| Net increase (decrease) in cash and cash equivalents | (89,646,698 | ) | 16,950,812 | |||||
| Cash and cash equivalents at beginning of period | 139,220,208 | 56,490,579 | ||||||
| Cash and cash equivalents at end of period | $ | 49,573,510 | $ | 73,441,391 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Issuance costs | $ | 85,000 | $ | — | ||||
| Non-cash investing and financing activities | ||||||||
| Contingent consideration | $ | — | $ | 3,270,579 | ||||
| Settlement of contingent consideration liability | $ | 2,688,147 | $ | — | ||||
| Non-cash financing costs included in accounts payable and accrued expenses | $ | 15,680 | $ | — | ||||
| CorHepta transaction costs | $ | — | $ | 175,000 | ||||
