Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 Commission file number 001-37581 ACLARIS THERAPEUTICS, INC. Incorporated under the Laws of the I.R.S. Employer Identification No. State of Delaware 46-0571712 701 Lee Road, Suite 103 Wayne, PA 19087 (484) 324-7933 Securities registered pursuant to Section 12(b) of the Act: Title of ...

Aclaris Therapeutics (ACRS) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.15. This compares to a loss of $0.1 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -9.59%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.13 per share when it actually produced a loss of $0.12, delivering a surprise of +7.69%.Over the last four qua ...

Aclaris Therapeutics (NasdaqGS:ACRS) FY Conference February 26, 2026 08:40 AM ET Company ParticipantsHugh Davis - President, COO and Member of the Board of DirectorsJesse Hall - Chief Medical OfficerNone - Company RepresentativeConference Call ParticipantsJeff Jones - Senior AnalystJeff JonesGood morning, everyone, and welcome back to day two of Oppenheimer's Annual Healthcare Conference. I'm Jeff Jones, one of the senior analysts on the team here, and I'm delighted to welcome multiple members from the Acla ...

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update - Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Anti-TSLP/IL-4Rα Bispecific Antibody ATI-052 Support Rapid Clinical Advancement; Complete Top Line Results Expected in the Second Quarter of 2026 - - Phase 1b Proof-of-Concept Trials of ATI-052 in Atopic Dermatitis (AD) and Asthma Underway; Top Line Results from Both Trials Anticipated in the Second Half ...

Core Insights - Aclaris Therapeutics reported positive interim results from its Phase 1a trials for the bispecific antibody ATI-052, indicating strong safety and tolerability, with complete results expected in Q2 2026 [1][3] - The company has initiated Phase 1b proof-of-concept trials for ATI-052 in atopic dermatitis and asthma, with top line results anticipated in the second half of 2026 [1][2] - Aclaris plans to file an Investigational New Drug (IND) application for its lead ITK inhibitor candidate, ATI-9494, in the second half of 2026 [1][12] Pipeline Developments - Positive interim results from the Phase 1a SAD/MAD trial of ATI-052 showed a favorable safety profile and robust target engagement, supporting potential extended dosing every three months [3][2] - Two Phase 1b POC trials for ATI-052 have been initiated, with results expected in the latter half of 2026 [3][2] - Planning for a Phase 2b program for ATI-052 is underway, targeting asthma and atopic dermatitis as initial indications [3] Financial Performance - Aclaris reported a net loss of $19.8 million for Q4 2025, a significant decrease from a net loss of $96.6 million in Q4 2024 [7] - Total revenue for Q4 2025 was $1.3 million, down from $9.2 million in Q4 2024, primarily due to a prior commercial milestone [8] - Research and development expenses increased to $16.6 million in Q4 2025 from $9.0 million in the prior year, driven by higher costs associated with product candidate development [9] Liquidity and Capital Resources - As of December 31, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $151.4 million, down from $203.9 million in 2024 [6][20] - The company believes its current financial resources will be sufficient to fund operations into the second half of 2028 [6]

WAYNE, Pa., Feb. 24, 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 that it has initiated a placebo-controlled Phase 1b proof-of-concept (POC) trial of ATI-052, the Company’s potential best-in-class investigational bispecific anti-TSLP/IL-4Rα antibody, in asthma. This announcement follows the recent initiation of the Company’s Phase 1b POC trial of ...

Aclaris Therapeutics Conference Call Summary Company Overview - **Company**: Aclaris Therapeutics (NasdaqGS: ACRS) - **Focus**: Clinical stage biopharmaceutical company specializing in large molecule and small molecule therapeutics [4][5] Key Developments and Programs Large Molecule Therapeutics - **TSLP Monoclonal Antibody**: Currently in a 90-patient study for moderate to severe atopic dermatitis (AD), with results expected in late 2026 [4] - **Bispecific Antibody**: Built off the TSLP monoclonal antibody with an IL-4R construct, showing highly positive pharmacokinetic/pharmacodynamic (PK/PD) data [4][5] - **Phase 1b Studies**: Ongoing studies for severe AD and moderate asthma, with readouts also expected in late 2026 [5] Small Molecule Therapeutics - **ITK Franchise**: Lead molecule 2138 is an ITK JAK3 inhibitor, ready for Phase IIb trials. The company is selecting a lead indication for this asset [5][6] - **Next Generation ITK**: Development of super selective ITK inhibitors, with IND enabling discussions ongoing [6] Clinical Data and Efficacy - **Bosakitug (TSLP-targeted monoclonal)**: Demonstrated a 94% EASI-75 response and an 88% IGA 0/1 in previous studies, indicating strong efficacy [9][10] - **Bispecific Antibody**: Achieved a 26-day half-life and demonstrated effective inhibition of TSLP and IL-4R, with a goal of maximizing response in AD and asthma [14][15][17] Safety and Tolerability - **Injection Site Reactions (ISRs)**: Most common adverse event observed, generally mild and resolving without intervention [20][21] - **Overall Safety Profile**: Data from chronic toxicity studies and Phase 2a trials indicate a clean safety profile for lead compounds [73] Competitive Landscape and Market Opportunities - **JAK Inhibitor Market**: Aclaris aims to differentiate its products by focusing on more selective ITK inhibitors, which may have fewer immunosuppressive effects compared to traditional JAK inhibitors [35][63] - **Potential Indications**: Considering various inflammatory disorders, including alopecia and lichen planus, as potential targets for 2138 [45][46] Future Catalysts - **Upcoming Trials**: Phase 1b studies for AD and asthma are expected to provide significant data on efficacy and safety [24][28] - **IND Filing**: Planned for the next generation ITK compound towards the end of the year, with expectations to catch up to competitors [75] Conclusion Aclaris Therapeutics is positioned to make significant advancements in the biopharmaceutical space with its innovative therapies targeting atopic dermatitis and asthma. The company is focused on maximizing efficacy while maintaining a favorable safety profile, with several key trials and developments on the horizon.

Core Viewpoint - Aclaris Therapeutics, Inc. is actively participating in two healthcare conferences in February 2026, showcasing its commitment to addressing immuno-inflammatory diseases through innovative product candidates [1][4]. Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for patients with immuno-inflammatory diseases who currently lack satisfactory treatment options [3]. - The company boasts a multi-stage portfolio of product candidates supported by a robust research and development engine [3]. Upcoming Events - On February 12, 2026, at 2:30 PM EST, Aclaris' CEO Dr. Neal Walker and senior leadership will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York, NY [4]. - On February 26, 2026, at 8:40 AM EST, Aclaris' President and COO Hugh Davis, Ph.D. will deliver a corporate presentation during the virtual Oppenheimer 36th Annual Healthcare Life Sciences Conference [4].

Core Insights - Aclaris Therapeutics announced positive preclinical results for ATI-2138, a potent ITK/JAK3 inhibitor, showing significant hair regrowth in a murine model of severe alopecia areata compared to ritlecitinib [1][2][3] Group 1: Drug Efficacy - ATI-2138 demonstrated rapid and near-complete hair regrowth in mice, achieving 87% regrowth at week 4 and 93% at week 6, compared to 48% and 78% for ritlecitinib respectively [3] - The study utilized a reversal model of alopecia universalis, indicating that ATI-2138 is effective even in older and more difficult-to-treat mice [2][3] Group 2: Mechanism of Action - ATI-2138 acts as a dual inhibitor of ITK and JAK3, affecting T cell receptor signaling and regulating T cell expansion and activation [2][7] - The drug is highly selective, being over 1,000-fold more potent against ITK and JAK3 than other JAK isoforms, which may lead to a strong anti-inflammatory response [2][7] Group 3: Future Development - Aclaris plans to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential in treating various inflammatory and autoimmune diseases, including alopecias [6][10] - The company is assessing additional indications for ATI-2138, leveraging its unique pharmacological profile [6][10] Group 4: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments for immuno-inflammatory diseases, with a robust R&D pipeline [8] - The company aims to address unmet medical needs in patients suffering from conditions that lack satisfactory treatment options [8]

Core Insights - Aclaris Therapeutics announced positive preclinical results for its ITK/JAK3 inhibitor ATI-2138, showing significant hair regrowth in a murine model of severe alopecia areata [1][2][3] Group 1: Drug Mechanism and Efficacy - ATI-2138 is a potent and selective dual inhibitor of ITK and JAK3, effectively downregulating various inflammatory markers and reducing itch, making it suitable for treating immuno-inflammatory diseases [2][6] - In a murine model, mice treated with 300 ppm ATI-2138 showed a mean hair regrowth of 37% at week 2 and 87% at week 4, compared to ritlecitinib's 25% and 48% respectively [3] - By week 6, the mean hair regrowth for ATI-2138 reached 93%, significantly outperforming ritlecitinib, which achieved 78% [3] Group 2: Future Development Plans - Aclaris plans to initiate a Phase 2b trial for ATI-2138 in the first half of 2026, exploring its potential in treating various inflammatory and autoimmune diseases, including alopecias [5][6] - The company is assessing additional indications for ATI-2138, leveraging its unique pharmacological profile to address unmet medical needs in immuno-inflammatory conditions [5][6] Group 3: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for patients with immuno-inflammatory diseases lacking satisfactory treatment options [7] - The company has a robust R&D pipeline aimed at addressing various inflammatory diseases, supported by preclinical and clinical data demonstrating the efficacy of its product candidates [7]