Key Highlights:

• Full top line results from the Phase 1a SAD/MAD trial of ATI-052 validate a potential best-in-class potency advantage and the opportunity for extended dosing.
• Timelines reaffirmed for upcoming top line results from Phase 1b proof-of-concept (POC) trials of ATI-052 and the Phase 2 trial of bosakitug (ATI-045).
• Strong cash runway expected to enable development of the pipeline through the end of 2028.

---

WAYNE, Pa., Aug. 06, 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 second quarter of 2026 and provided a corporate and clinical update.

"The first half of 2026 was a period of strong execution across the organization, positioning Aclaris for an exciting second half of the year with numerous expected key catalysts," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "We expect to provide three clinical data readouts, including placebo-controlled top line results from our two Phase 1b POC trials of our anti-TSLP/IL-4Rα bispecific antibody ATI-052 in both asthma and atopic dermatitis and the Phase 2 AD trial of our anti-TSLP monoclonal antibody bosakitug. Other key catalysts include initiation of a Phase 2b clinical program with ATI-052 and a Phase 2b trial in lichen planus with modzatinib. Finally, our data presented recently at the FASEB Immunoreceptors and Immunotherapy conference support the best-in-class potential of our investigational ITK inhibitor ATI-9494, for which we expect to file an IND late this year."

Second Quarter 2026 Highlights, Recent Updates, and Upcoming Catalysts

Biologics: Antibody Franchise

Phase 1a SAD/MAD Trial of ATI-052 (Anti-TSLP/IL-4Rα Bispecific Antibody): Aclaris provided positive full top line results from the Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) trial, validating potency and the potential for extended dosing. ATI-052 was well tolerated and demonstrated a favorable safety profile. The combination of strong and sustained pharmacokinetic (PK) duration and pharmacodynamic (PD) effect supported the potential for up to quarterly dosing. ATI-052 targets two cytokine pathways — TSLP and IL-4Rα — that have each been clinically validated by approved therapies: tezepelumab (Amgen/AstraZeneca's Tezspire) blocks TSLP, while dupilumab (Regeneron/Sanofi's Dupixent) blocks IL-4Rα. A single bispecific antibody engaging both targets could offer a differentiated profile in crowded inflammatory disease markets where both biologics already generate multibillion-dollar annual revenues.

Phase 1b POC Trials of ATI-052: Aclaris reaffirmed its expectation to report top line results in the second half of 2026 from two ongoing Phase 1b POC trials evaluating ATI-052 in both atopic dermatitis (AD) and asthma. These placebo-controlled readouts will be the first clinical efficacy signal for the bispecific approach in two of the largest immuno-inflammatory indications by patient population.

Phase 2b Program for ATI-052: Aclaris confirmed its intent to initiate a Phase 2b program encompassing asthma and AD with ATI-052 in the fourth quarter of 2026. The company expects the program to commence with a Phase 2b trial in asthma, followed by startup activities for a Phase 2b trial in AD and a POC trial in eosinophilic esophagitis (EoE). EoE has seen limited therapeutic options until recently, when dupilumab received approval for the indication in 2024, leaving room for additional mechanistic approaches.

Phase 2 Trial of Bosakitug (ATI-045): Aclaris remains on track for an expected fourth quarter 2026 readout of top line results from its Phase 2 trial of the investigational anti-TSLP monoclonal antibody bosakitug. Enrollment is complete in this randomized, double-blind, placebo-controlled trial designed to evaluate bosakitug in 109 patients with AD.

Kinase Inhibitors: ITK Franchise

Modzatinib (ATI-2138): Aclaris plans to initiate a Phase 2b clinical program for modzatinib, a potent and selective investigational inhibitor of ITK and JAK3, in the fourth quarter of 2026. The company intends to launch a multi-part Phase 2b trial of modzatinib in lichen planus, a chronic, inflammatory, CD8-driven interface dermatitis for which there are currently no approved therapies — an area of significant unmet medical need where existing off-label treatments such as corticosteroids and immunosuppressants offer limited durable benefit.

ATI-9494 (Dual Inhibitor of ITK and TXK): Aclaris is on track for an expected fourth quarter 2026 filing of an Investigational New Drug (IND) application for ATI-9494. The candidate has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications.

Preclinical Data for ATI-9494: New preclinical data presented at the 2026 Federation of American Societies for Experimental Biology (FASEB) Immunoreceptors and Immunology Science Research Conference characterized the potency, selectivity, and target occupancy of ATI-9494. Results from cellular target engagement studies demonstrated potent engagement of ITK by ATI-9494 and its ability to block functional activation of the TCR pathway. ATI-9494 demonstrated potency up to 25 times greater than soquelitinib (CPI-818) across multiple biochemical and functional cellular assays. Soquelitinib is in clinical development by Corvus Pharmaceuticals, making this head-to-head preclinical comparison a key competitive data point within the emerging ITK inhibitor class.

Financial Results

Liquidity and Capital Resources

As of June 30, 2026, Aclaris held cash, cash equivalents, and marketable securities of $170.6 million, compared to $151.4 million as of December 31, 2025.

Subsequent to June 30, 2026, the company sold 7.3 million shares of its common stock for aggregate gross proceeds of $40.2 million, pursuant to the company's at-the-market (ATM) agreement with Leerink Partners LLC and Cantor Fitzgerald & Co. These proceeds provide additional funds to support the planned commencement of startup activities for the Phase 2b trial of ATI-052 in AD and a POC trial in EoE.

Aclaris believes that its cash, cash equivalents, and marketable securities will be sufficient to fund operations through the end of 2028, without giving effect to any potential business development transactions or additional financing activities. This runway is expected to carry the company through multiple Phase 2 data readouts across its antibody and kinase inhibitor franchises.

Second Quarter and Year-to-Date 2026 Results

Aclaris reported a net loss of $21.5 million for the second quarter of 2026, compared to $15.4 million for the second quarter of 2025. For the six months ended June 30, 2026, the net loss was $41.3 million, compared to $30.5 million for the six months ended June 30, 2025. The wider losses reflect the company's accelerating clinical development activity across multiple programs transitioning from early-stage to Phase 2 readiness.

Total revenue was $1.6 million for the second quarter of 2026, compared to $1.8 million for the second quarter of 2025. For the six months ended June 30, 2026, total revenue was $3.6 million, compared to $3.2 million for the corresponding prior year period. The increase for the six-month period was primarily driven by higher royalties earned under the Lilly and Sun Pharma license agreements.

Research and development (R&D) expenses were $18.1 million for the quarter and $33.7 million for the six months ended June 30, 2026, compared to $11.4 million and $23.0 million for the corresponding prior year periods. The increases were primarily driven by expenses related to ATI-052, including product candidate manufacturing costs and clinical development expenses associated with the Phase 1a program and Phase 1b programs in AD and asthma, as well as product candidate manufacturing costs for ATI-9494.

General and administrative (G&A) expenses were $6.0 million for the quarter and $12.8 million for the six months ended June 30, 2026, compared to $5.4 million and $11.5 million for the prior year periods. The increases were primarily attributable to higher professional and legal expenses as well as personnel expenses.

Revaluation of contingent consideration resulted in a $0.3 million charge for both the quarter and six months ended June 30, 2026, compared to charges of $1.5 million and $1.8 million for the prior year periods. The decreases were primarily due to changes to the probability of success for certain product candidates and lower discount rates being applied to potential payments during the quarter and six months ended June 30, 2025.

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.

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 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 Aclaris' development programs for bosakitug, ATI-052, modzatinib (ATI-2138), and ATI-9494, including the timing of reporting top line results from the Phase 2 trial of bosakitug in AD and the Phase 1b trials of ATI-052 in asthma and AD, the clinical development plans for ATI-052 including the timing of initiating a Phase 2b trial in asthma, the timing of initiating a Phase 2b trial in lichen planus with modzatinib, 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 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 include those inherent in the conduct of preclinical and clinical studies, 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, uncertainty regarding the macroeconomic environment, and other risks and uncertainties 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.

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. 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