“The fourth quarter of 2025 was a transformational quarter for the Company as we transitioned to a global pivotal Phase 3 clinical study in Pulmonary Arterial Hypertension following receipt of a Written Response from a Type C interaction from the
Recent Developments:
- The Company is advancing IKT-001 into a global pivotal Phase 3 study in PAH:
- The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), has been initiated with regulatory approval and the recent activation of our first clinical sites in
the United States . - Following receipt from the
United States Food and Drug Administration (the “FDA”) of the Written Response from the Company’s Type C meeting interaction with the agency, the Company is initiating a two-part adaptive Phase 3 study.
- Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of Pulmonary Vascular Resistance (“PVR”) at Week 24.
- Part B of IMPROVE-PAH, which shall immediately commence enrollment following enrollment of the last patient in Part A, adopts an identical format to Part A, except the primary endpoint will be 6-minute walk distance (“6MWD”) at Week 24 in approximately 346 patients.
- The Company believes this adaptive Phase 3 study design has important advantages including: (1) permitting a 12-week dose-titration phase designed to get patients to the highest tolerable dose of IKT-001; (2) uninterrupted enrollment between Part A and Part B; and (3) the ability to, if necessary, undertake a sample size re-estimation for Part B based on Part A findings.
- IMPROVE-PAH is expected to be conducted in up to approximately 180 sites around the world.
- Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of Pulmonary Vascular Resistance (“PVR”) at Week 24.
- The Company is progressing regulatory approvals with submissions in over 20 countries together with receiving confirmation of acceptance under “Facilitating and Accelerating Strategic Trials in the European Union”, called FAST-EU, which is a pilot initiative that commenced on
January 30, 2026 to accelerate the approval of multinational clinical trials. FAST-EU offers a potential maximum 10-week (70-day) timeline for authorization, integrating Ethics Committee opinions and improving efficiency within the European Union Clinical Trials Information System.
- The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), has been initiated with regulatory approval and the recent activation of our first clinical sites in
Inhibikase successfully completed various required pre-clinical studies that are necessary to support an application to the FDA for Orphan Drug Designation for delivery of IKT-001 for PAH. Various information from these studies is expected to be presented at theAmerican Thoracic Society International Conference to be held inOrlando, Florida onMay 17 th and 20th, 2026.- In
November 2025 , the Company completed a$115 million underwritten public offering of its common stock and pre-funded warrants.
- Aggregate gross proceeds from this offering were approximately
$115 million , before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants.
- Aggregate gross proceeds from this offering were approximately
Financial Results
Cash Position: As of
Net Loss: Net loss for the year ended
R&D Expenses: Research and development expenses were
SG&A Expenses: Selling, general and administrative expenses for the year ended
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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 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 commence and 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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Consolidated Balance Sheets | ||||||||
2025 | 2024 | |||||||
| Assets | ? | |||||||
| Current assets: | ? | |||||||
| Cash and cash equivalents | $ | 139,220,208 | $ | 56,490,579 | ||||
| Marketable securities | 39,543,820 | 41,052,949 | ||||||
| Prepaid research and development | 1,001,993 | 81,308 | ||||||
| Prepaid expenses and other current assets | 343,374 | 826,473 | ||||||
| Total current assets | 180,109,395 | 98,451,309 | ||||||
| Equipment and improvements, net | — | 47,100 | ||||||
| Right-of-use asset | — | 101,437 | ||||||
| Prepaid research and development, noncurrent | 1,000,000 | — | ||||||
| Other assets | 95,121 | — | ||||||
| Total assets | $ | 181,204,516 | $ | 98,599,846 | ||||
| Liabilities and stockholders’ equity | ? | |||||||
| Current liabilities: | ? | |||||||
| Accounts payable | $ | 1,158,054 | $ | 943,019 | ||||
| Lease obligation, current | — | 110,517 | ||||||
| Accrued expenses and other current liabilities | 4,081,282 | 2,680,030 | ||||||
| Contingent consideration liability | 3,061,501 | — | ||||||
| Total current liabilities | 8,300,837 | 3,733,566 | ||||||
| Total liabilities | 8,300,837 | 3,733,566 | ||||||
| Commitments and contingencies (see Note 15) | ? | |||||||
| Stockholders’ equity: | ? | ? | ||||||
| Preferred stock, | — | — | ||||||
| Common stock, | 131,691 | 69,362 | ||||||
| Additional paid-in capital | 315,429,986 | 189,254,777 | ||||||
| Accumulated other comprehensive income (loss) | 21,802 | (37,248 | ) | |||||
| Accumulated deficit | (142,679,800 | ) | (94,420,611 | ) | ||||
| Total stockholders' equity | 172,903,679 | 94,866,280 | ||||||
| Total liabilities and stockholders’ equity | $ | 181,204,516 | $ | 98,599,846 | ||||
Consolidated Statements of Operations and Comprehensive Loss | ||||||||
| Year ended | ||||||||
| 2025 | 2024 | |||||||
| Costs and expenses: | ||||||||
| Research and development | $ | 29,793,146 | $ | 17,210,548 | ||||
| Selling, general and administrative | 23,555,079 | 11,378,520 | ||||||
| Change in fair value contingent consideration | (1,373,942 | ) | — | |||||
| Total costs and expenses | 51,974,283 | 28,589,068 | ||||||
| Loss from operations | (51,974,283 | ) | (28,589,068 | ) | ||||
| Interest income | 3,715,094 | 1,069,182 | ||||||
| Net loss | (48,259,189 | ) | (27,519,886 | ) | ||||
| Other comprehensive income (loss), net of tax | ||||||||
| Unrealized gain (loss) on marketable securities | 59,050 | (38,125 | ) | |||||
| Comprehensive loss | $ | (48,200,139 | ) | $ | (27,558,011 | ) | ||
| Net loss per share?–?basic and diluted | $ | (0.49 | ) | $ | (1.16 | ) | ||
| Weighted-average number of shares?–?basic and diluted | 98,310,190 | 23,712,220 | ||||||
Consolidated Statements of Cash Flows | ||||||||
| Year ended | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (48,259,189 | ) | $ | (27,519,886 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 60,499 | 26,272 | ||||||
| Stock-based compensation expense | 15,309,924 | 8,140,617 | ||||||
| Write-off of in-process research and development | 7,357,294 | — | ||||||
| Change in fair value of contingent consideration | (1,373,942 | ) | — | |||||
| Non-cash accretion on marketable securities | (936,975 | ) | — | |||||
| Changes in operating assets and liabilities: | ||||||||
| Operating lease right-of-use assets | 101,437 | 120,790 | ||||||
| Prepaid expenses and other current assets | 532,732 | (616,523 | ) | |||||
| Prepaid research and development | (1,920,685 | ) | 138,508 | |||||
| Other assets | (95,121 | ) | — | |||||
| Accounts payable | 146,827 | 271,782 | ||||||
| Operating lease liabilities | (110,517 | ) | (129,702 | ) | ||||
| Accrued expenses and other current liabilities | 1,401,252 | 420,075 | ||||||
| Net cash used in operating activities | (27,786,464 | ) | (19,148,067 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of equipment and improvements | (13,399 | ) | — | |||||
| Purchases of investments - marketable securities | (39,094,847 | ) | (60,455,103 | ) | ||||
| Maturities of investments - marketable securities | 41,600,000 | 23,450,902 | ||||||
| Acquired in-process research and development | (438,624 | ) | — | |||||
| Net cash provided by (used in) investing activities | 2,053,130 | (37,004,201 | ) | |||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock, pre-funded warrants and warrants, net of issuance costs | 107,617,495 | 103,477,668 | ||||||
| Issuance of common stock from exercise of stock options | 845,468 | — | ||||||
| Net cash provided by financing activities | 108,462,963 | 103,477,668 | ||||||
| Net increase in cash and cash equivalents | 82,729,629 | 47,325,400 | ||||||
| Cash and cash equivalents at beginning of year | 56,490,579 | 9,165,179 | ||||||
| Cash and cash equivalents at end of year | $ | 139,220,208 | $ | 56,490,579 | ||||
| Supplemental disclosures of cash flow information | ||||||||
| Issuance costs | $ | 7,359,783 | $ | 11,499,089 | ||||
| Non-cash investing and financing activities | ||||||||
| Contingent consideration | $ | 4,435,443 | $ | — | ||||
| Non-cash IPR&D acquired through common stock contingently issued shares | $ | 2,464,652 | $ | — | ||||
| Non-cash financing costs included in accounts payable | $ | 373,231 | $ | — | ||||
| CorHepta transaction costs | $ | 175,000 | $ | — | ||||
| Write-off of fully depreciated equipment and improvements | $ | 117,224 | $ | — | ||||
