Inhibikase Therapeutics Announces First Quarter 2025 Financial Results and Highlights Recent Activity

Rhea-AI Summary

Inhibikase Therapeutics (NASDAQ: IKT) reported its Q1 2025 financial results and recent developments. The company reported a net loss of $13.7 million ($0.15 per share) compared to $4.6 million in Q1 2024. R&D expenses increased to $10.5 million, including a $7.4 million non-cash charge for the CorHepta acquisition. SG&A expenses rose to $5.2 million from $2.0 million year-over-year.

The company strengthened its leadership team with key appointments, including Mark Iwicki as CEO. IKT is advancing IKT-001 toward a Phase 2b clinical trial in Pulmonary Arterial Hypertension (PAH) expected to begin in H2 2025. The company maintains a strong cash position of $93.2 million as of March 31, 2025.

[ "Strong cash position of $93.2 million to support operations", "Strengthened leadership team with key executive appointments", "Received 'Study May Proceed' letter for Phase 2b trial in September 2024", "Previous IMPRES Phase 3 study showed improved exercise capacity in PAH patients" ]

Positive

• None.

Negative

• Increased net loss to $13.7 million from $4.6 million year-over-year
• R&D expenses significantly increased to $10.5 million from $2.8 million
• SG&A expenses more than doubled to $5.2 million from $2.0 million

Insights

Pharmaceutical Industry Analyst

Inhibikase reports wider quarterly losses as it prepares for pivotal Phase 2b PAH trial with IKT-001, backed by $93.2M cash runway.

Inhibikase Therapeutics is positioning itself for a significant clinical advancement with IKT-001 for pulmonary arterial hypertension (PAH), a rare but serious condition characterized by high blood pressure in the arteries of the lungs. The company has assembled a new leadership team and is finalizing the protocol for its Phase 2b clinical trial expected to begin in H2 2025.

The financial results show a $13.7 million net loss ($0.15 per share) for Q1 2025, a substantial increase from the $4.6 million loss ($0.73 per share) in Q1 2024. This widening loss reflects the company's strategic investments in clinical development, including a $7.4 million non-cash charge related to the acquisition of CorHepta in February 2025. R&D expenses increased significantly to $10.5 million from $2.8 million year-over-year, while SG&A expenses more than doubled to $5.2 million.

Importantly, Inhibikase maintains a strong cash position of $93.2 million, providing essential runway for its planned clinical activities. The company's strategy builds on previous clinical evidence from the IMPRES Phase 3 study of imatinib mesylate, which demonstrated improved exercise capacity and hemodynamics in advanced PAH patients. IKT-001 contains the same active ingredient (imatinib) but potentially with a better tolerability profile.

The recent executive appointments—including CEO Mark Iwicki, President and R&D Head Chris Cabell, CSO John Adams, and CFO David McIntyre—represent a significant organizational restructuring aimed at executing the late-stage development strategy. The company has already received FDA clearance to proceed with the Phase 2b trial as of September 2024, an important regulatory milestone that reduces near-term developmental risk.

The Phase 2b study design is still being refined through consultations with key opinion leaders, indicating the company is taking a thoughtful approach to maximize probability of success in this specialized therapeutic area. PAH remains a disease with significant unmet medical need despite available therapies, presenting both market opportunity and clinical development challenges.

Advancing IKT-001 into a Late-Stage Clinical Trial Program in Pulmonary Arterial Hypertension

BOSTON and ATLANTA, May 14, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company innovating small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension (“PAH”), today reported financial results for the quarter ended March 31, 2025 and highlighted recent developments.

“During our first quarter of 2025, we continued to build out our senior leadership team and key infrastructure areas to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH,” said Mark Iwicki, Chief Executive Officer of Inhibikase. “With our core team now in place, and with ongoing refining of our study protocol with key opinion leaders, IKT is well placed to initiate our Phase 2b clinical study of IKT-001 in PAH in the second half of 2025.” The IMPRES Phase 3 study of imatinib mesylate previously demonstrated improved exercise capacity and hemodynamics in patients with advanced PAH. We continue to believe that systemic exposure of imatinib with IKT-001 can be well tolerated and provide strong efficacy to patients suffering from PAH.

Recent Developments:

• Announced the appointments of Mark Iwicki as Chief Executive Officer, Chris Cabell, M.D., M.H.S, FACC, as President and Head of Research & Development, and John Adams, Ph.D., as Chief Scientific Officer, and David McIntyre as Chief Financial Officer.
• Advancement of IKT-001 as a therapy in PAH:
  • The Company has continued to meet with key opinion leaders and other experts in PAH with a view to refining the Company’s proposed study design for the forthcoming Phase 2b clinical study of IKT-001 in PAH. The Company expects to finalize the study design in the ensuing weeks.
  • The Company previously received its “Study May Proceed” letter for the Phase 2b trial in September 2024, noting that the active ingredient in IKT-001, imatinib, has previously been shown to have a meaningful impact on key efficacy parameters such as 6 minute walk distance in advanced PAH.

First Quarter 2025 Financial Results

Net Loss: Net loss for the quarter ended March 31, 2025, was $13.7 million, or $0.15 per share, compared to a net loss of $4.6 million, or $0.73 per share in the quarter ended March 31, 2024.

R&D Expenses: Research and development expenses were $10.5 million for the quarter ended March 31, 2025, compared to $2.8 million for the quarter ended March 31, 2024. This includes a non-cash charge for in-process research and development expense of $7.4 million associated with the Company’s acquisition of CorHepta, which was effective on February 21, 2025.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2025 were $5.2 million compared to $2.0 million for the quarter ended March 31, 2024.

Cash Position: Cash, cash equivalents and marketable securities were $93.2 million as of March 31, 2025.

About Inhibikase (www.inhibikase.com)

Inhibikase Therapeutics, Inc. (Nasdaq: IKT) is a clinical-stage pharmaceutical company developing Abelson Tyrosine Kinase inhibitor therapeutics for Cardiopulmonary disease. Inhibikase’s cardiopulmonary disease portfolio is led by IKT-001, a prodrug of imatinib mesylate, for PAH. Inhibikase is headquartered in Wilmington, Delaware.

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 initiation of the Company’s Phase 2b trial of IKT-001 in PAH and the Company’s future activities, or future events or conditions; and expectations regarding the anticipated contribution of our new leadership team to our operations and progress. 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 ‘702’ 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. Consolidated Balance Sheets (Unaudited)
		March 31, 2025				December 31, 2024
		(unaudited)				(Note 3)
Assets						​
Current assets:						​
Cash and cash equivalents		$	73,441,391			$	56,490,579
Marketable securities			19,738,900				41,052,949
Prepaid research and development			52,475				81,308
Prepaid expenses and other current assets			931,992				826,473
Total current assets			94,164,758				98,451,309
Equipment and improvements, net			47,845				47,100
Right-of-use asset			68,719				101,437
Total assets		$	94,281,322			$	98,599,846
Liabilities and stockholders’ equity						​
Current liabilities:						​
Accounts payable		$	1,692,051			$	943,019
Lease obligation, current			74,772				110,517
Accrued expenses and other current liabilities			3,513,248				2,680,030
Contingent consideration liability			3,270,579				—
Total current liabilities			8,550,650				3,733,566
Total liabilities			8,550,650				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 March 31, 2025 and December 31, 2024			—				—
Common stock, $0.001 par value; 500,000,000 and 100,000,000 shares authorized; 74,341,540 and 69,362,439 shares issued and outstanding (including 4,149,252 and 0 contingently issuable shares - see Note 10) at March 31, 2025 and December 31, 2024, respectively			74,341				69,362
Additional paid-in capital			193,756,644				189,254,777
Accumulated other comprehensive loss			(967	)			(37,248	)
Accumulated deficit			(108,099,346	)			(94,420,611	)
Total stockholders' equity			85,730,672				94,866,280
Total liabilities and stockholders’ equity		$	94,281,322			$	98,599,846

Inhibikase Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
		Three Months Ended March 31,
		2025				2024
Costs and expenses:
Research and development		$	10,513,579			$	2,751,279
Selling, general and administrative			5,249,291				2,031,081
Change in fair value contingent consideration			(1,164,864	)			—
Total costs and expenses			14,598,006				4,782,360
Loss from operations			(14,598,006	)			(4,782,360	)
Interest income			919,271				132,725
Net loss			(13,678,735	)			(4,649,635	)
Other comprehensive income (loss), net of tax
Unrealized gain (loss) on marketable securities			36,281				(2,677	)
Comprehensive loss		$	(13,642,454	)		$	(4,652,312	)
Net loss per share – basic and diluted		$	(0.15	)		$	(0.73	)
Weighted-average number of shares – basic and diluted			89,537,171				6,340,697

FAQ

What were Inhibikase Therapeutics (IKT) Q1 2025 financial results?

IKT reported a net loss of $13.7 million ($0.15 per share), R&D expenses of $10.5 million, and SG&A expenses of $5.2 million. The company had $93.2 million in cash and equivalents as of March 31, 2025.

When will Inhibikase Therapeutics (IKT) begin its Phase 2b trial for IKT-001?

Inhibikase Therapeutics plans to initiate its Phase 2b clinical study of IKT-001 in PAH in the second half of 2025.

Who are the new executives appointed at Inhibikase Therapeutics (IKT)?

IKT appointed Mark Iwicki as CEO, Chris Cabell as President and Head of R&D, John Adams as Chief Scientific Officer, and David McIntyre as Chief Financial Officer.

What is the cash position of Inhibikase Therapeutics (IKT) as of Q1 2025?

Inhibikase Therapeutics reported cash, cash equivalents and marketable securities of $93.2 million as of March 31, 2025.

What is IKT-001 being developed for?

IKT-001 is being developed as a therapy for Pulmonary Arterial Hypertension (PAH), with previous studies showing improved exercise capacity and hemodynamics in patients with advanced PAH.