BOSTON and ATLANTA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- 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 quarter ended September 30, 2025 and highlighted recent developments.
"During our third quarter of 2025, we continued to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH," said Mark Iwicki, Chief Executive Officer of Inhibikase. "We expect to initiate our Phase 2b clinical study of IKT-001, our prodrug of imatinib mesylate, in PAH during the fourth quarter of 2025."
Recent Developments:
-- Advancement of IKT-001 as a therapy in PAH:
-- The proposed Phase 2b IMPROVE-PAH trial is a multi-center,
randomized, double-blind, placebo-controlled study of
approximately 150 PAH participants. Participants under IMPROVE-PAH
will be randomized 1:1:1 to receive 300 mg IKT-001, 500 mg
IKT-001, or placebo once daily for 26 weeks, in addition to stable
background PAH therapy. The Company's bioequivalence studies
previously confirmed that 500 mg of IKT-001 has comparable
exposure in humans to 383 mg of imatinib. The primary efficacy
endpoint is change in pulmonary vascular resistance at Week 26.
Secondary endpoints include 6-minute walk distance, World Health
Organization functional class, and pharmacokinetics. The study
protocol also includes an interim safety review for study
continuance by the Data Safety Monitoring Board with at least 50
patients at 12-weeks of follow-up.
-- The Company has been actively working with potential sites and
presently expects to initiate IMPROVE-PAH in the fourth quarter of
2025.
-- Appointed veteran biopharma executive Timothy Pigot as the Company's
Chief Commercial and Strategy Officer.
-- The Company also expects to present at the Jefferies Global Healthcare
Conference in London on Monday, November 17th, 2025.
Financial Results
Cash Position: As of September 30, 2025, cash, cash equivalents and marketable securities were $77.3 million as compared to $97.5 million as of December 31, 2024.
Net Loss: Net loss for the quarter ended September 30, 2025, was $11.9 million, or $0.13 per share, compared to a net loss of $5.8 million, or $0.65 per share in the quarter ended September 30, 2024. Net loss for the nine months ended September 30, 2025, was $35.5 million, or $0.40 per share, compared to a net loss of $15.4 million, or $2.03 per share, for the nine months ended September 30, 2024.
R&D Expenses: Research and development expenses were $7.6 million for the quarter ended September 30, 2025, compared to $4.2 million for the quarter ended September 30, 2024. Research and development expenses were $23.4 million for the nine months ended September 30, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $1.8 million of stock-based compensation expense, both associated with the Company's acquisition of CorHepta in February 2025, compared to $10.0 million for the nine months ended September 30, 2024.
SG&A Expenses: Selling, general and administrative expenses for the quarter ended September 30, 2025 were $5.6 million, compared to $1.6 million for the quarter ended September 30, 2024. Selling, general and administrative expenses for the nine months ended September 30, 2025 were $16.8 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $5.6 million for the nine months ended September 30, 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, PAH, that arise from aberrant signaling through the Abelson Tyrosine Kinase, and type III receptor tyrosine kinases including platelet derived growth factor receptors and c-KIT. Our lead product candidate is IKT-001, a prodrug of imatinib mesylate, for PAH which is an orphan indication. PAH is a progressive, life-threatening disease characterized by pulmonary vascular remodeling and elevated pulmonary vascular resistance that affects approximately 50,000 Americans.
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 initiation of the Company's Phase 2b trial of IKT-001 in PAH, including timing related thereto, 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 2b 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.
Contacts:
Investor Relations:
Michael Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
---tables to follow---
Inhibikase Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
September 30, December 31,
2025 2024
------------- ------------
(unaudited) (Note 3)
Assets
Current assets:
Cash and cash equivalents $ 38,269,706 $ 56,490,579
Marketable securities 39,052,511 41,052,949
Prepaid research and development 210,566 81,308
Deferred offering costs 385,062 --
Prepaid expenses and other
current assets 618,783 826,473
------------ -----------
Total current assets 78,536,628 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 57,913 --
------------ -----------
Total assets $ 79,594,541 $ 98,599,846
============ ===========
Liabilities and stockholders'
equity
Current liabilities:
Accounts payable $ 620,528 $ 943,019
Lease obligation, current -- 110,517
Accrued expenses and other
current liabilities 3,656,383 2,680,030
Contingent consideration
liability 2,419,332 --
------------ -----------
Total current liabilities 6,696,243 3,733,566
------------ -----------
Total liabilities 6,696,243 3,733,566
------------ -----------
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
September 30, 2025 and December
31, 2024 -- --
Common stock, $0.001 par value;
500,000,000 and 100,000,000 shares
authorized; 74,807,911 and
69,362,439 shares issued and
outstanding (including 4,149,252
and 0 contingently issuable shares
-- see Note 10) at September 30,
2025 and December 31, 2024,
respectively 74,808 69,362
Additional paid-in capital 202,772,828 189,254,777
Accumulated other comprehensive
loss (4,189) (37,248)
Accumulated deficit (129,945,149) (94,420,611)
------------ -----------
Total stockholders' equity 72,898,298 94,866,280
------------ -----------
Total liabilities and
stockholders' equity $ 79,594,541 $ 98,599,846
============ ===========
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Operations and
Comprehensive Loss
(Unaudited)
Three Months Ended Nine months ended September
September 30, 30,
-------------------------- ---------------------------
2025 2024 2025 2024
------------ ----------- ------------ ------------
Costs and
expenses:
Research and
development $ 7,649,697 $ 4,189,873 $ 23,434,243 $ 10,016,982
Selling, general
and
administrative 5,611,503 1,637,603 16,780,525 5,643,386
Change in fair
value
contingent
consideration (492,827) -- (2,016,111) --
----------- ---------- ----------- -----------
Total costs and
expenses 12,768,373 5,827,476 38,198,657 15,660,368
----------- ---------- ----------- -----------
Loss from
operations (12,768,373) (5,827,476) (38,198,657) (15,660,368)
Interest income 838,093 49,410 2,674,119 273,059
----------- ---------- ----------- -----------
Net loss (11,930,280) (5,778,066) (35,524,538) (15,387,309)
Other
comprehensive
income (loss),
net of tax
Unrealized gain
(loss) on
marketable
securities (1,245) 2,778 33,059 877
----------- ---------- ----------- -----------
Comprehensive loss $(11,931,525) $(5,775,288) $(35,491,479) $(15,386,432)
----------- ---------- ----------- -----------
Net loss per share
-- basic and
diluted $ (0.13) $ (0.65) $ (0.40) $ (2.03)
=========== ========== =========== ===========
Weighted-average
number of shares
-- basic and
diluted 90,050,973 8,882,570 89,867,805 7,592,103
=========== ========== =========== ===========
Inhibikase Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Nine months ended September 30,
-----------------------------------
2025 2024
------------------ --------------
Cash flows from operating
activities
Net loss $ (35,524,538) $ (15,387,309)
Adjustments to reconcile net
loss to net cash used in
operating activities:
Depreciation 60,499 19,705
Stock-based compensation
expense 10,776,144 232,155
Write-off of in-process
research and development 7,357,294 --
Change in fair value of
contingent consideration (2,016,111) --
Noncash accretion on
marketable securities (570,503) --
Changes in operating assets
and liabilities:
Operating lease
right-of-use assets 101,437 89,122
Prepaid expenses and other
assets 257,321 698
Prepaid research and
development (1,129,258) 107,592
Other assets (57,913) --
Accounts payable (390,699) 1,329,135
Operating lease liabilities (110,517) (95,009)
Accrued expenses and other
current liabilities 976,353 (98,581)
-------------- -------------
Net cash used in operating
activities (20,270,491) (13,802,492)
-------------- -------------
Cash flows from investing
activities
Purchases of equipment and
improvements (13,399) --
Purchases of investments --
marketable securities (38,996,000) (10,343,939)
Maturities of investments --
marketable securities 41,600,000 12,101,463
Acquired in-process research
and development (438,624) --
-------------- -------------
Net cash provided by investing
activities 2,151,977 1,757,524
-------------- -------------
Cash flows from financing
activities
Deferred offering costs (385,062) --
Proceeds from issuance of
common stock, pre-funded
warrants and warrants, net of
issuance costs 150 3,793,209
Issuance of common stock from
exercise of stock options 282,553 --
-------------- -------------
Net cash provided by (used in)
financing activities (102,359) 3,793,209
-------------- -------------
Net decrease in cash and cash
equivalents (18,220,873) (8,251,759)
Cash and cash equivalents at
beginning of period 56,490,579 9,165,179
-------------- -------------
Cash and cash equivalents at
end of period $ 38,269,706 $ 913,420
============== =============
Supplemental disclosures of
cash flow information
Issuance costs $ -- $ 1,203,350
============== =============
Non cash investing and
financing activities
Non-cash financing costs
included in accounts payable $ -- $ 553,318
CorHepta transaction costs $ 175,000 $ --
Contingent consideration $ 2,419,332 $
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