Form 8-K
8-K — Inhibikase Therapeutics, Inc.
Accession: 0001193125-26-344623
Filed: 2026-08-11
Period: 2026-08-11
CIK: 0001750149
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — d134059d8k.htm (Primary)
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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): August 11, 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 August 11, 2026, Inhibikase Therapeutics, Inc. announced its financial results for the quarter ended June 30, 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 August 11, 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: August 11, 2026
INHIBIKASE THERAPEUTICS, INC.
By:
/s/ Mark Iwicki
Mark Iwicki
Chief Executive Officer
EX-99.1
EX-99.1
Filename: d134059dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Inhibikase Therapeutics Announces Second Quarter 2026
Financial Results and Highlights Recent Activity
WILMINGTON, Del., August 11, 2026 — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or
“Company”), a clinical-stage pharmaceutical company developing IKT-001, a novel once-daily oral anti-proliferative for Pulmonary Arterial Hypertension (“PAH”), today reported financial
results for the quarter ended June 30, 2026, and highlighted recent developments.
“During our second quarter and in recent weeks we continued
to advance our Phase 3 IMPROVE-PAH study with 26 country regulatory approvals together with the recent initiation of 43 clinical sites across a range of countries,” said Mark Iwicki, Chief Executive
Officer of Inhibikase. “Also, during the quarter, favorable results of pre-clinical and Phase 1 studies of IKT-001 were presented at the American Thoracic
Society International Conference, with data demonstrating improvements in pulmonary vascular and hemodynamic markers of PAH and lower potential for GI toxicity compared to imatinib mesylate. Together with the recent grant of Orphan Drug
Designation from the U.S. FDA and the $50 million proceeds from the sale of shares to RA Capital, Inhibikase is well-positioned to advance IKT-001 toward its potential as the first once-daily oral
anti-proliferative offering significant potential benefits to the PAH patient population.”
Recent Developments
•
In April 2026, Inhibikase received confirmation from the European Medicines Agency that the Company is permitted
to initiate its 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). Globally, regulatory approvals for the Phase 3 study have been obtained in 26 countries with 3 additional country approvals pending and 4 additional country regulatory
submissions planned.
•
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 enrollment of the last patient in Part A and adopts an identical format to Part A except the
primary endpoint of Part B is change in 6-minute walk distance (“6MWD”) at Week 24 in approximately 346 patients.
•
In July 2026, the Company sold 25,000,000 shares of the Company’s common stock to RA Capital Management
through its at-the-market (“ATM”) facility for gross proceeds of $50 million. Subsequently, in July 2026, 18,030,000 of these shares of common stock
were exchanged for pre-funded warrants to purchase shares of common stock.
•
In July 2026, the FDA’s Office of Orphan Products Development granted Orphan Drug Designation
(“ODD”) for IKT-001. ODD provides potential development incentives, including eligibility for tax credits on qualified clinical trial costs, exemption from certain FDA user fees, and the potential
for seven years of market exclusivity upon regulatory approval.
1
Presentations
•
In May 2026, pre-clinical and Phase 1 data for IKT-001 were presented at the American Thoracic Society (“ATS”) International Conference in Orlando, Florida. These presentations included data demonstrating the following:
•
The potential for IKT-001 to have an improved gastro-intestinal
(“GI”) side-effect profile, including gastric emptying benefits and reduced impairment of intestinal motility compared to imatinib mesylate. IKT-001 remains intact in the stomach and the intestine
and is not converted to imatinib until it reaches the blood, with in vitro pharmacology studies demonstrating an 18-fold decrease in c-Kit inhibition which has been
implicated in the GI side-effects of imatinib.
•
Single doses of IKT-001 resulted in rapid and dose proportional exposure
of circulating imatinib, which were well tolerated over a 300-800 mg range with no indication of dose-dependent GI toxicities.
Financial Results
Cash Position: As of
June 30, 2026, cash, cash equivalents and marketable securities were $159.0 million. Subsequent to the close of the quarter the Company announced that it had sold 25,000,000 shares of the Company’s common stock to RA Capital
Management through its ATM facility for gross proceeds of $50 million. The Company expects that the additional capital raised through this financing, together with existing cash reserves, will support operations through topline data readout in
Part B of the ongoing global Phase 3 IMPROVE-PAH clinical study, assuming the full and timely exercise of the outstanding Series A and B Warrants.
As of June 30, 2026, there were 132.0 million shares of common stock and 42.5 million pre-funded
warrants outstanding.
Net Loss: Net loss for the quarter ended June 30, 2026, was $19.6 million, or $0.11 per share, compared to a net
loss of $9.9 million, or $0.11 per share in the quarter ended June 30, 2025. Net loss for the six months ended June 30, 2026, was $36.0 million, or $0.21 per share, compared to a net loss of $23.6 million, or $0.26 per
share, for the six months ended June 30, 2025.
R&D Expenses: Research and development expenses were $13.4 million for the quarter
ended June 30, 2026, compared to $5.3 million for the quarter ended June 30, 2025. Research and development expenses were $24.2 million for the six months ended June 30, 2026, compared to $15.8 million for the six
months ended June 30, 2025.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2026 were
$7.7 million, compared to $5.9 million for the quarter ended June 30, 2025. Selling, general and administrative expenses for the six months ended June 30, 2026 were $15.0 million, compared to $11.2 million for the six
months ended June 30, 2025, which included $1.0 million of severance expenses for prior senior executives of the Company.
2
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 of IKT-001,
including its potential to become a once-daily oral anti-proliferative treatment for PAH and its potential benefits to patients with PAH, the advancement of the Company’s global pivotal Phase 3 clinical study of
IKT-001 in PAH, including the timing, design, initiation 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, the
potential benefits of Orphan Drug Designation, the Company’s expectations regarding its cash runway and ability to fund operations through topline data readout in Part B of IMPROVE-PAH, 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.
3
Contacts:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
---tables to follow---
4
Inhibikase Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
June 30,
2026
December 31,
2025
Assets
Current assets:
Cash and cash equivalents
$
31,206,707
$
139,220,208
Marketable securities
127,812,140
39,543,820
Prepaid research and development
2,346,641
1,001,993
Prepaid expenses and other current assets
933,938
343,374
Deferred offering costs
44,489
—
Total current assets
162,343,915
180,109,395
Prepaid research and development, noncurrent
1,000,000
1,000,000
Other assets
244,697
95,121
Total assets
$
163,588,612
$
181,204,516
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
991,720
$
1,158,054
Accrued expenses and other current liabilities
9,268,306
4,081,282
Contingent consideration liability
—
3,061,501
Total current liabilities
10,260,026
8,300,837
Total liabilities
10,260,026
8,300,837
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 June 30, 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 June 30, 2026 and December 31, 2025, respectively
132,032
131,691
Additional paid-in capital
331,921,179
315,429,986
Accumulated other comprehensive income (loss)
(72,754
)
21,802
Accumulated deficit
(178,651,871
)
(142,679,800
)
Total stockholders’ equity
153,328,586
172,903,679
Total liabilities and stockholders’ equity
$
163,588,612
$
181,204,516
5
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Costs and expenses:
Research and development
$
13,393,464
$
5,270,967
$
24,232,614
$
15,784,546
Selling, general and administrative
7,657,531
5,919,731
15,033,654
11,169,022
Change in fair value contingent consideration
—
(358,420
)
(373,354
)
(1,523,284
)
Total costs and expenses
21,050,995
10,832,278
38,892,914
25,430,284
Loss from operations
(21,050,995
)
(10,832,278
)
(38,892,914
)
(25,430,284
)
Other income
1,459,764
916,755
2,920,843
1,836,026
Net loss
(19,591,231
)
(9,915,523
)
(35,972,071
)
(23,594,258
)
Other comprehensive income (loss), net of tax Unrealized gain (loss) on marketable
securities
(46,461
)
(1,977
)
(94,556
)
34,304
Comprehensive loss
$
(19,637,692
)
$
(9,917,500
)
$
(36,066,627
)
$
(23,559,954
)
Net loss per share – basic and diluted
$
(0.11
)
$
(0.11
)
$
(0.21
)
$
(0.26
)
Weighted-average number of shares – basic and diluted
174,571,543
90,009,625
173,445,493
89,774,703
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Six months ended June 30,
2026
2025
Cash flows from operating activities
Net loss
$
(35,972,071
)
$
(23,594,258
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
—
36,812
Stock-based compensation expense
10,905,776
6,250,938
Write-off of
in-process research and development
—
7,357,294
Change in fair value contingent consideration
(373,354
)
(1,523,284
)
Non-cash accretion on marketable securities
(1,969,587
)
—
Changes in operating assets and liabilities:
Operating lease
right-of-use assets
—
66,519
Prepaid expenses and other current assets
(590,564
)
7,526
Prepaid research and development
(1,344,648
)
(57,547
)
Other assets
(149,576
)
—
Accounts payable
(196,334
)
1,592,656
Operating lease liabilities
—
(72,573
)
Accrued expenses and other current liabilities
5,187,024
258,156
Net cash used in operating activities
(24,503,334
)
(9,677,761
)
Cash flows from investing activities
Purchases of equipment and improvements
—
(13,399
)
Purchases of investments - marketable securities
(145,618,289
)
—
Maturities of investments - marketable securities
59,225,000
31,350,103
Acquired in-process research and development
—
(438,624
)
Net cash provided by (used in) investing activities
(86,393,289
)
30,898,080
Cash flows from financing activities
Deferred offering costs
(14,489
)
—
Proceeds from issuance of common stock, pre-funded
warrants and warrants, net of issuance costs
2,897,611
150
Issuance of common stock from exercise of options
—
31,621
Net cash provided by financing activities
2,883,122
31,771
Net increase (decrease) in cash and cash equivalents
(108,013,501
)
21,252,090
Cash and cash equivalents at beginning of period
139,220,208
56,490,579
Cash and cash equivalents at end of period
$
31,206,707
$
77,742,669
Supplemental disclosures of cash flow information
Issuance costs
$
85,000
$
—
Non-cash investing and financing
activities
Contingent consideration
$
—
$
2,912,159
Settlement of contingent consideration liability
$
2,688,147
$
—
Non-cash financing costs included in accounts payable and
accrued expenses
$
30,000
$
307,373
CorHepta transaction costs
$
—
$
175,000
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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
+ Details
Name:
dei_PreCommencementTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Title of a 12(b) registered security.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
+ Details
Name:
dei_Security12bTitle
Namespace Prefix:
dei_
Data Type:
dei:securityTitleItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
+ Details
Name:
dei_SecurityExchangeName
Namespace Prefix:
dei_
Data Type:
dei:edgarExchangeCodeItemType
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 soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
+ Details
Name:
dei_SolicitingMaterial
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
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:
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Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration