[8-K] Inhibikase Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Inhibikase Therapeutics plans to advance its drug candidate IKT-001 directly into a global pivotal Phase 3 trial for pulmonary arterial hypertension (PAH). The Phase 3 IMPROVE-PAH study is expected to start in the first quarter of 2026 and use a two-part adaptive design. Part A will be a double-blind, placebo-controlled study in 140 patients with a primary endpoint of pulmonary vascular resistance at Week 24, while Part B will use the same format in 346 patients with a primary endpoint of six-minute walk distance at Week 24. The company believes this design offers advantages such as dose titration to the highest tolerable dose, uninterrupted enrollment, and potential sample size re-estimation. Inhibikase also terminated its at-the-market sales agreement prospectus with Jefferies, having made no stock sales under it, although the underlying sales agreement remains in effect.

Insights

Biotech and capital markets analyst

Inhibikase moves IKT-001 into pivotal Phase 3 PAH trial and closes unused ATM prospectus.

Inhibikase Therapeutics now expects to take IKT-001 straight into a global pivotal Phase 3 trial in pulmonary arterial hypertension instead of running a separate Phase 2b study. After a Type C interaction with the FDA, the company plans the adaptive IMPROVE-PAH study, with Part A focusing on pulmonary vascular resistance at Week 24 in 140 patients and Part B on six-minute walk distance at Week 24 in 346 patients.

This design allows a 12-week dose-titration period to reach the highest tolerable dose, continuous enrollment between Parts A and B, and the possibility of re-estimating the Part B sample size based on Part A findings. The trial is expected to begin in the first quarter of 2026 and be conducted at up to approximately 180 sites globally, which underscores the scale of the program.

On the financing side, Inhibikase terminated its at-the-market offering prospectus under its Sales Agreement with Jefferies after making no sales under that program. The Sales Agreement itself remains in force, so future use would require a new prospectus or registration statement.

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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): November 20, 2025

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 8.01. Other Events.

On November 20, 2025, Inhibikase Therapeutics, Inc. (the “Company”) announced that it expects to advance IKT-001 to a global pivotal Phase 3 clinical study in Pulmonary Arterial Hypertension (“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), is expected to be initiated in the first quarter of 2026. The Company previously planned to initiate a Phase 2b study in 150 subjects in PAH prior to advancing to a pivotal Phase 3 study. However, the Company submitted a Type C Meeting request to the U.S. Food & Drug Administration (“FDA”) to, among other things, obtain feedback on an immediate transition to a single pivotal Phase 3 study design. Following receipt from the FDA of the Written Response from the Type C interaction, the Company now plans to initiate a two-part adaptive Phase 3 study. The Company expects Part A of IMPROVE-PAH will be a double blind, placebo-controlled study in 140 patients with a primary endpoint of PVR at Week 24. The Company expects Part B will adopt an identical format to Part A except the primary endpoint will be 6MWD at Week 24 in 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. Given the Company was well-advanced in initiating the previous Phase 2b study design, the Company expects to initiate IMPROVE-PAH in the first quarter of 2026, with this study expected to be conducted in up to approximately 180 sites around the world.

On November 20, 2025, the Company updated its corporate presentation for use in meetings with investors, analysts and others from time to time. A copy of the presentation is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.

Effective November 20, 2025, the Company terminated the sales agreement prospectus (the “ATM Prospectus”) filed with the Company’s registration statement on Form S-3 (File No. 333- 288213) and related to the shares of our common stock issuable pursuant to the Open Market Sale Agreement^SM, dated June 20, 2025 (the “Sales Agreement”), by and between the Company and Jefferies LLC. As of the date hereof, the Company had not made any sales pursuant to the ATM Prospectus. Further, the Company will not make any sales of common stock pursuant to the Sales Agreement, unless and until a new prospectus, prospectus supplement or a new registration statement is filed. Other than the termination of the ATM Prospectus, the Sales Agreement remains in full force and effect.

Forward Looking Statements

This Current Report on Form 8-K 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, expectations regarding the Company’s Phase 3 trial of IKT-001 in PAH, including design, timing of initiation and its impact on the Company’s timeline; and the Company’s future activities, 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 trial 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99.1		Corporate Presentation of Inhibikase Therapeutics, Inc., dated November 2025.
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: November 20, 2025				INHIBIKASE THERAPEUTICS, INC.
				By:		/s/ Mark Iwicki
						Mark Iwicki
						Chief Executive Officer

FAQ

What did Inhibikase Therapeutics (IKT) announce about IKT-001 for PAH?

Inhibikase announced that it expects to advance IKT-001 directly into a global pivotal Phase 3 clinical study for pulmonary arterial hypertension (PAH), rather than conducting a separate Phase 2b trial first.

What is the design of Inhibikase's IMPROVE-PAH Phase 3 trial?

The IMPROVE-PAH Phase 3 trial will be a two-part adaptive study. Part A will enroll 140 patients in a double-blind, placebo-controlled design with a primary endpoint of pulmonary vascular resistance at Week 24. Part B will use the same format in 346 patients with a primary endpoint of six-minute walk distance at Week 24.

When will the IMPROVE-PAH Phase 3 study of IKT-001 start and how large will it be?

The company expects to initiate the IMPROVE-PAH Phase 3 study in the first quarter of 2026, and it is expected to be conducted in up to approximately 180 sites around the world.

Why did Inhibikase change from a planned Phase 2b study to a pivotal Phase 3 trial for IKT-001?

Inhibikase had planned a Phase 2b study in 150 PAH subjects, but after submitting a Type C Meeting request to the FDA and receiving a Written Response, it now plans a single two-part adaptive Phase 3 design that it believes offers advantages such as dose titration, uninterrupted enrollment, and possible sample size re-estimation.

What happened to Inhibikase Therapeutics' at-the-market (ATM) offering program?

Effective November 20, 2025, Inhibikase terminated the ATM Prospectus related to its Form S-3 registration and Open Market Sale Agreement with Jefferies LLC. The company had made no sales of common stock under this ATM Prospectus, and no further sales will occur under it unless a new prospectus or registration statement is filed.

Did Inhibikase file any new investor materials with this 8-K?

Yes. Inhibikase updated its corporate presentation for use with investors and analysts, and this presentation is attached as Exhibit 99.1 and incorporated by reference.