Form 8-K

8-K — Inhibikase Therapeutics, Inc.

Accession: 0001193125-26-219610

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001750149

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

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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): May 12, 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 2.02.

Results of Operations and Financial Condition.

On May 12, 2026, Inhibikase Therapeutics, Inc. announced its financial results for the quarter ended March 31, 2026 and other corporate updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in 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, as amended, 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 May 12, 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: May 12, 2026

INHIBIKASE THERAPEUTICS, INC.

By:

/s/ Mark Iwicki

Mark Iwicki

Chief Executive Officer

EX-99.1

Filename: d119997dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Inhibikase Therapeutics Announces First Quarter 2026

Financial Results and Highlights Recent Activity

WILMINGTON, Del., May 12, 2026 — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or

“Company”), a clinical-stage pharmaceutical company developing IKT-001 for Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the quarter ended March 31,

2026, and highlighted recent developments.

“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 European Union) initiative to accelerate multinational clinical trials,”

said Mark Iwicki, Chief Executive Officer of Inhibikase. “With the recent approvals obtained in the first 16 countries worldwide, Inhibikase is well-positioned to initiate clinical site activations and seek to advance enrollment of IMPROVE-PAH. Later this week, we also look forward to the first of two new presentations of Phase 1 and pre-clinical studies of IKT-001

at the American Thoracic Society International Conference, to be held in Orlando, Florida.”

Recent Developments

•

In late April 2026, Inhibikase received confirmation from the European 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 the European Union. This approval brings the total country approvals for IMPROVE-PAH to 16, including the United

States, Canada, New Zealand and Argentina, and further enables the Company to leverage this approval to seek the approval of an additional 3 countries in the European 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.

•

In April 2026, Inhibikase announced that IMPROVE-PAH has been initiated

with the recent activation of our first clinical sites in the 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

of the United States are now advancing.

•

In April 2026, Inhibikase submitted an Orphan Drug Designation (“ODD”) application to the U.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 in Orlando, Florida on May 17 and 20, 2026:

•

Safety, Tolerability, and Pharmacokinetics of IKT-001, a Novel Prodrug of

Imatinib, in Healthy Volunteers, on May 17, 2026

•

In Vitro Pharmacology and Preclinical Efficacy of IKT-001 in Pulmonary

Arterial Hypertension, on May 20, 2026.

Financial Results

Cash Position: As of March 31, 2026, cash, cash equivalents and marketable securities were $170.4 million.

Net Loss: Net loss for the quarter ended March 31, 2026, was $16.4 million, or $0.10 per share, compared to a net loss of $13.7 million,

or $0.15 per share in the quarter ended March 31, 2025.

R&D Expenses: Research and development expenses were $10.8 million for the

quarter ended March 31, 2026, compared to $10.5 million for the quarter ended March 31, 2025, which included a one-time (non-cash) charge of

$7.4 million for the acquired IPR&D related to the CorHepta acquisition.

SG&A Expenses: Selling, general and administrative expenses

for the quarter ended March 31, 2026 were $7.4 million, compared to $5.2 million for the quarter ended March 31, 2025.

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 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, 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. 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

—tables to

follow—

Inhibikase Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

March 31,

2026

December 31,

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

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, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding

at March 31, 2026 and December 31, 2025

—

Common stock, $0.001 par value; 500,000,000 shares authorized; 132,032,636 and 131,691,237 shares

issued and outstanding (including 0 and 4,149,252 contingently issuable shares - see Note 10) at March 31, 2026 and December 31, 2025, respectively

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

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three months ended March 31,

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

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

Three months ended

March 31,

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

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