Aclaris Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

Aclaris Therapeutics (NASDAQ:ACRS) reported Q2 2025 financial results and provided significant pipeline updates. The company achieved positive results in its Phase 2a trial of ATI-2138, their ITK/JAK3 inhibitor for atopic dermatitis, demonstrating strong efficacy and tolerability. Additionally, Aclaris initiated dosing in two key trials: a Phase 2 trial of bosakitug (anti-TSLP antibody) and a Phase 1a/1b program for ATI-052 (anti-TSLP/IL-4R bispecific antibody).

Financially, Aclaris reported a net loss of $15.4 million in Q2 2025, with cash reserves of $180.9 million as of June 30, 2025. The company expects its current cash position to fund operations into the second half of 2028. R&D expenses increased to $11.4 million, primarily due to expanded clinical development activities.

Positive

• Strong cash position of $180.9M expected to fund operations into second half of 2028
• Positive Phase 2a trial results for ATI-2138 showing strong efficacy and tolerability in atopic dermatitis
• Advancement of pipeline with initiation of Phase 2 trial for bosakitug and Phase 1a/1b for ATI-052
• Potential for additional non-dilutive opportunities to extend cash runway

Negative

• Net loss increased to $15.4M in Q2 2025 from $11.0M in Q2 2024
• Total revenue decreased to $1.8M in Q2 2025 from $2.8M in Q2 2024
• R&D expenses increased to $11.4M from $8.8M year-over-year
• G&A expenses rose to $5.4M from $4.8M in the corresponding quarter

Insights

Biotech Analyst

Aclaris reports positive clinical results for ATI-2138 in atopic dermatitis and strong cash runway into 2028, validating their ITK inhibition approach.

Aclaris Therapeutics delivered a robust second quarter update with several significant clinical advancements across their immuno-inflammatory pipeline. The standout achievement is the positive Phase 2a results for ATI-2138, their ITK/JAK3 inhibitor for atopic dermatitis (AD). These results are particularly noteworthy as they validate ITK as a therapeutic target while demonstrating comparable efficacy to approved JAK inhibitors but with potentially improved safety – addressing a critical limitation of existing JAK inhibitors which carry black box warnings.

The company is advancing two additional promising candidates: bosakitug (ATI-045), an anti-TSLP monoclonal antibody now in Phase 2 for AD, and ATI-052, a bispecific anti-TSLP/IL-4R antibody that entered Phase 1 testing. This multi-pronged approach targeting different immunological pathways provides multiple shots on goal in the competitive inflammatory disease space.

Financially, Aclaris reported a net loss of $15.4 million for Q2 2025, wider than the $11 million loss in Q2 2024. This increased loss reflects their expanded clinical development activities with R&D expenses rising to $11.4 million from $8.8 million year-over-year. Revenue decreased to $1.8 million from $2.8 million, primarily due to the partial sale of royalty payments from their Eli Lilly agreement.

Most importantly, with $180.9 million in cash and equivalents, Aclaris projects a runway into the second half of 2028 – unusually strong for a clinical-stage biotech company. This financial stability enables them to advance multiple clinical programs without immediate financing pressure while exploring additional non-dilutive funding opportunities. The extended runway significantly de-risks their clinical development strategy and provides flexibility to pursue optimal clinical pathways for their most promising assets.

- Positive Clinical Results from Phase 2a Trial of ITK/JAK3 Inhibitor ATI-2138 Confirm Tolerability Profile, Show Strong Efficacy Signal, and Validate ITK as Therapeutic Target -

- Advanced Anti-TSLP Monoclonal Antibody Bosakitug (ATI-045) into Phase 2 Trial in Atopic Dermatitis (AD);
Patient Dosing Underway -

- Initiated Dosing in Phase 1a/1b Clinical Program for Anti-TSLP/IL-4R Bispecific Antibody ATI-052 -

- Strong Cash Runway Expected to Fund Operations into the Second Half of 2028 -

WAYNE, Pa., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2025 and provided a corporate update.

“Aclaris is in a period of strong execution throughout the business as we advance our innovative therapies toward our goal of improving therapeutic options for patients with certain I&I diseases,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “For example, the results from the single arm Phase 2a clinical trial of our ITK/JAK3 inhibitor ATI-2138 represent a significant achievement for our ITK franchise by both confirming the strong tolerability profile and mechanism of ATI-2138 in AD ahead of our planned alopecia areata clinical trial and validating ITK as an important therapeutic target. Importantly, with an expected cash runway that funds our operations into the second half of 2028, we have sufficient capital to execute our strategic plan. We are also exploring additional non-dilutive opportunities to extend our cash runway even further.”

Second Quarter 2025 Highlights and Recent Updates

Pipeline:

• Achieved Primary and Key Secondary Endpoints in Phase 2a Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3: Positive results from this open-label, single arm trial further confirmed the favorable tolerability profile of ATI-2138, demonstrated clinically meaningful improvements from baseline in assessments of disease severity in patients with moderate-to-severe AD receiving low doses of ATI-2138, and validated ITK as a therapeutic target. Overall, these results provide evidence that the contribution of ITK may enable ATI-2138, even at low doses, to achieve efficacy results comparable to approved JAK inhibitors in moderate-to-severe AD, but with improved tolerability and without the significant safety risks typically associated with JAK inhibition. (press release here)
• Initiated Dosing in Phase 2 Trial of Potential Best-in-Class Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Patient dosing is ongoing in the randomized, double-blind, placebo-controlled global Phase 2 trial designed to evaluate bosakitug in approximately ninety (90) patients with moderate-to-severe AD. The Company expects to provide top line results in the second half of 2026. (press release here)
• Initiated Dosing in Phase 1a/1b Program for Potential Best-in-Class Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052: Dosing is ongoing in the randomized, blinded, placebo-controlled Phase 1a portion, designed to evaluate single and multiple ascending doses of ATI-052 in healthy adults. The Phase 1b proof-of-concept portion in up to two indications is expected to follow the Phase 1a portion. Aclaris expects to complete the Phase 1a portion by year-end 2025 and provide top line results in early 2026, followed by top line results from the Phase 1b portion in the second half of 2026. (press release here)
  
  

Corporate:

• Strong Cash Runway Funds the Company’s Planned Operations into the Second Half of 2028: The Company is assessing potential non-dilutive opportunities to extend the cash runway further.
• Provided Update on Senior Leadership: Roland Kolbeck, Ph.D. has been appointed as Chief Scientific Officer, replacing Joe Monahan, Ph.D. who will remain with the Company as Special Scientific Advisor to the Chief Executive Officer through the first quarter of 2026 as part of his planned retirement. (press release here)

Financial Results

Liquidity and Capital Resources

As of June 30, 2025, Aclaris had cash, cash equivalents and marketable securities of $180.9 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2028, without giving effect to any potential business development transactions or financing activities.

Second Quarter 2025 and Year-to-Date 2025

Net loss was $15.4 million for the second quarter of 2025 compared to $11.0 million for the second quarter of 2024. Net loss was $30.5 million for the six months ended June 30, 2025 compared to $27.9 million for the six months ended June 30, 2024.

Total revenue was $1.8 million for the second quarter of 2025 compared to $2.8 million for the second quarter of 2024. Total revenue was $3.2 million for the six months ended June 30, 2025 compared to $5.2 million for the six months ended June 30, 2024. The decrease for both comparison periods was primarily driven by the sale of a portion of royalty payments under the Company’s agreement with Eli Lilly and Company to OCM IP Healthcare Portfolio IP, an investment vehicle for Ontario Municipal Employees Retirement System (OMERS), in July 2024.

Research and development (R&D) expenses were $11.4 million and $23.0 million for the quarter and six months ended June 30, 2025, respectively, compared to $8.8 million and $18.6 million for the corresponding prior year periods. The increases were primarily driven by product candidate manufacturing costs, preclinical development activities, and clinical development expenses associated with the Phase 2 trial in AD for bosakitug and the Phase 1a/1b program for ATI-052. For the six-month comparison period, clinical development expenses associated with the Phase 2a trial in AD for ATI-2138 also contributed to the increase. The increases were partially offset by a reduction in development expenses for zunsemetinib for both comparison periods.

General and administrative (G&A) expenses were $5.4 million for the quarter ended June 30, 2025 compared to $4.8 million for the corresponding prior year period. The increase was primarily driven by higher personnel expenses as a result of higher headcount. G&A expenses were $11.5 million for the six months ended June 30, 2025 compared to $11.6 million for the six months ended June 30, 2024. The decrease was primarily driven by lower personnel expenses as a result of lower termination benefits.

Revaluation of contingent consideration resulted in a $1.5 million charge for the quarter ended June 30, 2025 compared to a $0.2 million charge for the prior year period. The increase was primarily due to changes to the probability of success for certain product candidates and lower discount rates resulting from changes in credit spreads being applied to potential payments during the quarter ended June 30, 2025. For the six months ended June 30, 2025, revaluation of contingent consideration resulted in a charge of $1.8 million compared to $3.0 million for the prior year period. The decrease was primarily due to changes in estimated sales levels and changes to the probability of success for certain product candidates during the six months ended June 30, 2024.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its plans for its development programs for bosakitug, ATI-2138 and ATI-052, including the anticipated timing of reporting results from its Phase 2 trial of bosakitug in AD and its Phase 1a/1b program of ATI-052, the potential to evaluate ATI-052 in up to two undisclosed indications in a Phase 1b program, the development of ATI-2138 in AA and additional indications, the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into the second half of 2028, and the Company’s plans to pursue non-dilutive financing opportunities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the “Risk Factors” section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Contacts:

Kevin Balthaser
Chief Financial Officer
(484) 329-2178
kbalthaser@aclaristx.com

Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com

Aclaris Therapeutics, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data)
	Three Months Ended								Six Months Ended
	June 30,								June 30,
	2025				2024				2025								2024
Revenues:
Contract research	$	442			$	625			$	887							$		1,281
Licensing		1,335				2,141				2,345									3,882
Total revenue		1,777				2,766				3,232									5,163
Costs and expenses:
Cost of revenue(1)		515				624				1,021									1,433
Research and development(1)		11,449				8,759				23,033									18,604
General and administrative(1)		5,386				4,752				11,525									11,596
Licensing		1,335				1,285				2,345									2,316
Revaluation of contingent consideration		1,500				200				1,800									3,000
Total costs and expenses		20,185				15,620				39,724									36,949
Loss from operations		(18,408	)			(12,854	)			(36,492				)					(31,786	)
Other income:
Interest income		2,018				1,868				4,184									3,859
Non-cash royalty income		961				—				1,794									—
Total other income		2,979				1,868				5,978									3,859
Net loss	$	(15,429	)		$	(10,986	)		$	(30,514				)			$		(27,927	)
Net loss per share, basic and diluted	$	(0.13	)		$	(0.15	)		$	(0.25				)			$		(0.39	)
Weighted average common shares outstanding, basic and diluted		122,580,967				71,291,400				122,486,162									71,183,129
(1) Amounts include stock-based compensation expense as follows:
Cost of revenue	$	190			$	223			$	409							$		475
Research and development		1,106				1,097				2,291									1,068
General and administrative		1,767				1,583				3,898									3,449
Total stock-based compensation expense	$	3,063			$	2,903			$	6,598							$		4,992

Aclaris Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data)
	June 30,			December 31,
	2025			2024
Cash, cash equivalents and marketable securities	$	180,890		$	203,896
Total assets	$	189,147		$	220,327
Total current liabilities	$	26,839		$	31,596
Total liabilities	$	57,408		$	64,773
Total stockholders' equity	$	131,739		$	155,554
Common stock outstanding		108,328,794			107,850,124

Aclaris Therapeutics, Inc. Selected Consolidated Cash Flow Data (unaudited, in thousands)
	Six Months Ended
	June 30,
	2025				2024
Net loss	$	(30,514	)		$	(27,927	)
Depreciation and amortization		242				485
Stock-based compensation expense		6,598				4,992
Revaluation of contingent consideration		1,800				3,000
Changes in operating assets and liabilities		(1,176	)			(13,687	)
Net cash used in operating activities	$	(23,050	)		$	(33,137	)

FAQ

What were the key financial results for Aclaris Therapeutics (ACRS) in Q2 2025?

Aclaris reported a net loss of $15.4M, total revenue of $1.8M, and ended the quarter with $180.9M in cash and equivalents. R&D expenses were $11.4M, and G&A expenses were $5.4M.

What were the Phase 2a trial results for Aclaris's ATI-2138 in atopic dermatitis?

The trial achieved primary and key secondary endpoints, demonstrating clinically meaningful improvements in disease severity with low doses, while maintaining a favorable tolerability profile. Results suggested efficacy comparable to approved JAK inhibitors but with improved tolerability.

How long can Aclaris fund its operations with current cash reserves?

Aclaris's current cash position of $180.9M is expected to fund operations into the second half of 2028, with potential for extension through non-dilutive opportunities.

What are the next major clinical milestones for Aclaris's pipeline?

Aclaris expects to provide top-line results for bosakitug's Phase 2 trial in H2 2026, complete the Phase 1a portion of ATI-052 by end of 2025 with results in early 2026, and Phase 1b results in H2 2026.

What management changes occurred at Aclaris in Q2 2025?

Dr. Roland Kolbeck was appointed as Chief Scientific Officer, replacing Dr. Joe Monahan who will remain as Special Scientific Advisor to the CEO through Q1 2026 as part of his planned retirement.