Form 8-K

8-K — Inhibikase Therapeutics, Inc.

Accession: 0001193125-26-144582

Filed: 2026-04-07

Period: 2026-04-07

CIK: 0001750149

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — d108350d8k.htm (Primary)

EX-99.1 (d108350dex991.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 7, 2026

INHIBIKASE THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

001-39676

26-3407249

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

1000 N. West Street, Suite 1200

Wilmington, DE

19801

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (302) 295-3800

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.001 par value

IKT

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01.

Regulation FD Disclosure

On April 7, 2026, Inhibikase Therapeutics, Inc. issued a press release titled “Inhibikase Therapeutics Announces Enrollment of First Patient in IMPROVE-PAH Global Phase 3 Study of IKT-001 in the Treatment of Pulmonary Arterial Hypertension.” A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

99.1

Press Release issued by Inhibikase Therapeutics, Inc., dated April 7, 2026, furnished herewith.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: April 7, 2026

INHIBIKASE THERAPEUTICS, INC.

By:

/s/ Mark Iwicki

Mark Iwicki

Chief Executive Officer

EX-99.1

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EX-99.1

Exhibit 99.1

Inhibikase Therapeutics Announces Enrollment of

First Patient in IMPROVE-PAH Global Phase 3 Study of IKT-001

in the Treatment of Pulmonary Arterial Hypertension

WILMINGTON, Del., April 7th, 2026 — Inhibikase Therapeutics, Inc. (Nasdaq:

IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension (“PAH”), announced today that the first

patient has been enrolled in the Company’s pivotal Phase 3 study IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and

Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332).

“Enrollment of the first patient in our IMPROVE-PAH trial is a major milestone for Inhibikase, and the result of many months of work to optimize the IKT-001 study plan to permit a single pivotal global study and

significantly accelerate the timeline to potential NDA filing,” said Mark Iwicki, Chief Executive Officer of Inhibikase. IKT-001 is a novel oral prodrug of imatinib mesylate designed to reduce

gastrointestinal (“GI”) side effects commonly observed with imatinib. Under the revised pivotal Phase 3 design, as confirmed in the written responses received from the FDA, Inhibikase has adopted an adaptive study design and a 12-week dose-titration phase to allow for optimized dosing. With over two decades of imatinib clinical experience, together with the potential GI benefits of IKT-001,

Inhibikase believes IMPROVE-PAH has a high probability of success.

The global

IMPROVE-PAH trial is 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 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. The Company believes this

Phase 3 study design has important advantages including permitting a 12-week dose-titration phase designed to get patients to the highest tolerable dose of IKT-001, as

well as uninterrupted enrollment between Part A and Part B. The Phase 3 study protocol also permits a sample size re-estimation for Part B based on Part A findings, if necessary.

IMPROVE-PAH is expected to be conducted in up to approximately 180 sites around the world.

“The Phase 3

IMPRES study demonstrated that imatinib may improve key parameters associated with PAH, including exercise capacity and hemodynamics,” said Dr. Harrison Farber, Co-director of Pulmonary Hypertension

Center and Director of the Pulmonary Embolism Response Team (PERT), Tufts Medical Center. “Now, the Phase 3 IMPROVE-PAH study will help evaluate both hemodynamic and functional improvements, as well as

key measures of disease progression, such as time to clinical worsening. Despite the availability of multiple therapies, many patients with PAH continue to experience disease progression, so I am always excited about the potential for a novel

antiproliferative agent for the treatment of PAH.”

“For patients living with PAH disease progression remains a daily reality even with the

therapies we have available today,” said Dr. J. Wesley McConnell, M.D., Director of Norton Pulmonary Specialists Pulmonary Hypertension Center in Louisville, Kentucky. “The IMPROVE-PAH trial

represents a meaningful step forward because the trial is designed to capture the outcomes that matter most to patients and clinicians alike. I am proud to be part of this program and optimistic about what it could mean for the future of PAH

care”.

About Inhibikase (www.inhibikase.com)

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary

diseases, namely, Pulmonary Arterial Hypertension (“PAH”), in which aberrant signaling through type III receptor tyrosine kinases, including platelet derived growth factor receptors and a stem cell factor receptor, known as “c-Kit” has been implicated. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate (“imatinib”), for PAH which is an orphan

indication. Imatinib was first approved in the United States in 2001 for various cancers and blood disorders and, following more than 20 years of clinical use, has a well-characterized safety profile with the first reported use of imatinib in PAH

occurring in 2005. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans. Our single pivotal Phase 3 clinical study

in PAH in approximately 180 sites around the world, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome

Variables in a Phase 3 Evaluation of PAH), is actively enrolling patients.

Social Media Disclaimer

Investors and others should note that the Company announces material financial information to investors using its investor relations website, press releases,

SEC filings and public conference calls and webcasts. The Company intends to also use LinkedIn and YouTube as a means of disclosing information about the Company, its services and other matters and for complying with its disclosure

obligations under Regulation FD.

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, enrollment, conduct and results of the IMPROVE-PAH study and related regulatory submissions, including the potential for NDA submission, 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. Inhibikase undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable

securities laws.

Contacts:

Investor Relations:

Michael Moyer

LifeSci Advisors

mmoyer@lifesciadvisors.com

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