Aclaris Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate and Clinical Update

ACRS

Published on 05/07/2026 at 06:59 am EDT

- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing -

- Unique Dual Mechanism of ATI-2138 Supports Planned Phase 2b Clinical Trial in Lichen Planus -

- Strong Cash Runway Expected to Enable Development of Pipeline Through 2028 -

WAYNE, Pa., May 07, 2026 (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 first quarter of 2026 and provided a corporate and clinical update.

“Since the start of 2026, we have made great progress toward our goal of developing best-in-class compounds to address a variety of immuno-inflammatory diseases,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “Most recently, the positive results from our Phase 1a SAD/MAD trial of our bispecific antibody ATI-052 confirmed its potential as having a best-in-class PK/PD profile with an extended dosing schedule of up to every three months. We look forward to an exciting rest of the year with expected milestones including delivery of placebo-controlled top line results from our Phase 1b proof-of-concept trials of ATI-052 in both asthma and atopic dermatitis and the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in atopic dermatitis.”

First Quarter 2026 Highlights and Recent Updates

Pipeline:

Biologics: Antibody Franchise

Oral Inhibitors: ITK Franchise

Financial Results

Liquidity and Capital Resources

In March 2026, the Company sold 18.4 million shares of its common stock for aggregate gross proceeds of $59.8 million, pursuant to the Company’s amended and restated sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., as sales agents.

As of March 31, 2026, Aclaris had cash, cash equivalents and marketable securities of $190.8 million compared to $151.4 million as of December 31, 2025. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2028, without giving effect to any potential business development transactions or financing activities.

First quarter 2026

Net loss was $19.8 million for the first quarter of 2026 compared to $15.1 million for the first quarter of 2025.

Total revenue was $2.0 million for the first quarter of 2026 compared to $1.5 million for the first quarter of 2025. The increase was primarily driven by higher royalties earned under the Lilly and Sun Pharma license agreements.

Research and development (R&D) expenses were $15.7 million for the quarter ended March 31, 2026 compared to $11.6 million for the prior year period. The increase was primarily driven by expenses related to ATI-052, including clinical development expenses associated with a Phase 1a program and Phase 1b programs in AD and asthma, as well as product candidate manufacturing costs for ATI-9494. The increase was partially offset by a reduction in preclinical and clinical development expenses for ATI-2138.

General and administrative (G&A) expenses were $6.7 million for the quarter ended March 31, 2026 compared to $6.1 million for the prior year period. The increase was primarily due to an increase in professional and legal expenses as well as personnel expenses.

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 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-052, ATI-2138 and ATI-9494, including the timing of reporting top line results from its Phase 2 trial of bosakitug in AD and its Phase 1b trials of ATI-052 in asthma and AD, the timing of initiating a Phase 2b program for ATI-052, the timing of initiating a Phase 2b trial in lichen planus with ATI-2138, the timing to file an IND for ATI-9494, the potential for ATI-052 to have extended dosing, the therapeutic potential of its product candidates and the potential for such candidates to be best-in-class, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations through the end of 2028. 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, 2025, 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 BalthaserChief Financial Officer(484) [email protected]

Will RobertsSenior Vice PresidentCorporate Communications and Investor Relations(484) [email protected]

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