Form 8-K
8-K — Inhibikase Therapeutics, Inc.
Accession: 0001193125-26-126322
Filed: 2026-03-26
Period: 2026-03-26
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): March 26, 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 March 26, 2026, Inhibikase Therapeutics, Inc. announced its financial results for the year ended December 31, 2025 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 March 26, 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: March 26, 2026
INHIBIKASE THERAPEUTICS, INC.
By:
/s/ Mark Iwicki
Mark Iwicki
Chief Executive Officer
EX-99.1
EX-99.1
Filename: d119328dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Inhibikase Therapeutics Announces Full Year 2025
Financial Results and Highlights Recent Activity
WILMINGTON, Del., March 26, 2026 — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or
“Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the year ended
December 31, 2025 and highlighted recent developments.
“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 United States Food and Drug Administration,” said Mark Iwicki, Chief
Executive Officer of Inhibikase. “With regulatory submissions in over 20 countries already filed and our first sites initiated, we are well-placed to advance enrollment in our global pivotal study, called
IMPROVE-PAH, in PAH.”
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.
•
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.
•
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 the American
Thoracic Society International Conference to be held in Orlando, Florida on May 17th 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.
Financial Results
Cash Position: As of
December 31, 2025, cash, cash equivalents and marketable securities were $178.8 million as compared to $97.5 million as of December 31, 2024.
Net Loss: Net loss for the year ended December 31, 2025, was $48.3 million, or $0.49 per share, compared to a net loss of $27.5 million,
or $1.16 per share in the year ended December 31, 2024.
R&D Expenses: Research and development expenses were $29.8 million for the
year ended December 31, 2025, which includes a non-cash write-off of in-process research and development of
$7.4 million and $2.5 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $17.2 million for the year ended December 31, 2024.
SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2025 were $23.6 million, which includes
$1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $11.4 million for the year ended December 31, 2024.
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, 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. 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.
Consolidated Balance Sheets
December 31,
2025
December 31,
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, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding
at December 31, 2025 and December 31, 2024
—
—
Common stock, $0.001 par value; 500,000,000 and 100,000,000 shares authorized; 131,691,237 and
69,362,439 shares issued and outstanding (including 4,149,252 and 0 contingently issuable shares - see Note 7) at December 31, 2025 and December 31, 2024, respectively
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
Inhibikase Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
Year ended December 31,
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
Inhibikase Therapeutics, Inc.
Consolidated Statements of Cash Flows
Year ended December 31,
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
$
—
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Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
Name:
dei_TradingSymbol
Namespace Prefix:
dei_
Data Type:
dei:tradingSymbolItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration