ACRS

EX-99.1

2 acrs-ex99d1.htm

EX-99.1

Exhibit 99.1

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

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- Initiation of Phase 2b Trial of Modzatinib (ATI-2138) in Lichen Planus Expected in Fourth Quarter of 2026 -

- Timeline Reaffirmed for Top Line Results from Phase 2 ADMIRATION Trial of Bosakitug (ATI-045) in Atopic Dermatitis (AD) -

- Positive Primary Analysis Results Announced from Phase 1b Proof-of-Concept (POC) Trials of ATI-052 in AD and Asthma -

- Strong Cash Runway Expected to Enable Development of Pipeline Through the First Half of 2029 -

WAYNE, Pa., November 5, 2026 -- 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 third quarter of 2026 and provided a corporate and clinical update.

“Aclaris is developing unique product candidates designed to provide improved therapeutic options across a variety of inflammatory disorders with the goal of raising the efficacy ceiling, and our recent progress reflects continued execution toward that objective,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “We recently announced strongly positive primary analysis results from our Phase 1b POC trials with ATI-052 in AD and asthma; we look forward to starting a Phase 2b trial in eosinophilic esophagitis early next year. Beyond that, we have a series of expected clinical and regulatory milestones throughout the rest of 2026 and 2027, including Phase 2 results in AD from bosakitug and the start of the Phase 2b trial of our oral ITK/JAK3 inhibitor modzatinib in lichen planus, both in the coming few weeks.”

Third Quarter 2026 Highlights, Recent Updates and Upcoming Catalysts

Pipeline:

Biologics: Antibody Franchise

●Positive Primary Analysis Results Demonstrated Rapid Improvement in Skin and Itch in Phase 1b POC Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 in Severe AD: Patients treated with ATI-052 experienced a 45% placebo-adjusted mean change in EASI score from baseline at week 8 with durable responses for the subset of patients with available data observed through week 16 (follow up ongoing) and a 78% placebo-adjusted EASI-50 at week 8. Patients who received ATI-052 experienced a 43% placebo-adjusted mean improvement in itch (PP-NRS) at week 8. ATI-052 was well tolerated and demonstrated a favorable safety profile. No conjunctivitis was observed. (press release here)

●Normalization of Lesional Skin Toward Baseline with ATI-052 Observed in Pharmacodynamic Results in AD: Marked normalization observed in the lesional skin proteome at week 8 in patients receiving ATI-052, with immune protein expression resembling that of non-lesional skin. ATI-052 induced a broad pathway downregulation, with modulation across multiple inflammatory pathways, Th1, Th2 and Th17/Th22, fibrosis/ECM remodeling, and itch-associated molecular pathways. (press release here)

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●Positive Primary Analysis Results Showed Rapid Improvement in Airway Inflammation and Lung Function in Phase 1b POC Trials of ATI-052 in Asthma: Following a single dose of ATI-052, patients experienced a rapid 59% mean absolute reduction in fractional exhaled nitric oxide (FeNO) (45 ppb) only 15 days after administration and a 40% reduction at day 29. Patients receiving ATI-052 experienced a placebo adjusted and absolute 200 ml improvement in Forced Expiratory Volume in 1 Second (FEV1) at day 15. Safety and tolerability were consistent with that of the Phase 1b AD POC trial, including no observations of conjunctivitis. (press release here)

●Aclaris to Prioritize Development of ATI-052 in Eosinophilic Esophagitis (EoE): Consistent with its development strategy and capital management discipline, Aclaris intends to prioritize Phase 2b development of ATI-052 initially in EoE, where the Company believes ATI-052 is mechanistically well-matched. The Company expects to complete its assessment of an additional Phase 2b indication shortly, likely either AD or asthma.

●Readout of Top Line Results from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug Expected in the Fourth Quarter 2026: The randomized, double-blind, placebo-controlled Phase 2 ADMIRATION trial is evaluating the efficacy and safety of bosakitug in 109 patients with moderate-to-severe atopic dermatitis.

Kinase Inhibitors: ITK Franchise

●Initiation of Phase 2b Clinical Trial in Lichen Planus for Investigational Oral ITK/JAK3 Inhibitor Modzatinib Expected in the Fourth Quarter of 2026: Startup activities are ongoing with first site activation expected in November 2026 for this Phase 2b trial in lichen planus, an unaddressed chronic, inflammatory, CD8-driven interface dermatitis. There are currently no approved therapies in this indication.

●Filing of Investigational New Drug (IND) Appli

EX-99.1

2 acrs-ex99d1.htm

EX-99.1

Exhibit 99.1

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Aclaris Therapeutics Announces Positive Phase 1b Proof-of-Concept Primary Analysis Results for its Anti-TSLP/IL-4Rα Bispecific ATI-052 in Atopic Dermatitis (AD) and Asthma

- Results Demonstrated Breadth and Rapidity of Response to ATI-052 in Heterogeneous Patient Populations; Pharmacodynamic Results Demonstrated Potential for Additivity/Synergy of Targeting TSLP and IL-4Rα -

- Rapid and Durable Improvement in Skin and Itch Observed in Severe AD Population with ATI-052; Single Dose Rapidly Improved Airway Inflammation and Lung Function in Diverse Asthma Population -

- ATI-052 Demonstrated Favorable Safety and Tolerability Profile Including No Observations of Conjunctivitis -

- Aclaris to Prioritize Development in Eosinophilic Esophagitis (EoE), Consistent with Development Strategy -

- Aclaris to Host Conference Call this Morning at 8:00 AM ET-

WAYNE, Pa., October 27, 2026 -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced positive primary analysis results from the Phase 1b proof-of-concept (POC) trials of its anti-TSLP/IL-4Rα bispecific antibody ATI-052 in atopic dermatitis and asthma. Both trials demonstrated strong proof-of-concept with rapid and broad responses to ATI-052, further validating the additive/synergistic potential of simultaneously targeting TSLP, IL-4, and IL-13 with a bispecific anti-TSLP/IL-4Rα antibody, and achieved the primary objective, showing a favorable safety profile including no observations of conjunctivitis. Slides accompanying this announcement will be available for download at the time of the conference call here.

Aclaris intends to prioritize Phase 2b development of ATI-052 initially in EoE, where the Company believes a focused development program is well aligned with its development strategy and disciplined capital management.

“These strong results convey ‘the art of the possible’ with this bispecific mechanism in heterogeneous diseases across diverse patient populations and support that this is a potent, broadly acting compound with potential best-in-class activity,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “Across heterogeneous patient populations, we observed breadth and depth of response, normalization of the immune proteome, encouraging early durability, evidence of potential synergy of targets, and a favorable safety profile associated with ATI-052 – all of which clarify its potential across indications. Consistent with our development strategy, we intend to prioritize initiating a Phase 2b trial in EoE early next year and provide an update on plans for a potential additional indication in the near term.”

Primary Analysis Results: Safety

ATI-052 was well tolerated across both trials and demonstrated a favorable safety profile. Treatment-emergent adverse events (TEAEs) observed in these POC trials were predominantly Grade 1. There were no Grade 3 or 4 TEAEs, and no adverse events led to study discontinuation. Injection site reactions (ISR) were transient, almost exclusively Grade 1, and observed at a low frequency. No conjunctivitis was observed.

Phase 1b POC Trial in Atopic Dermatitis (AD)

The randomized (3:1), double-blind, placebo-controlled Phase 1b trial evaluated the safety and tolerability of ATI-052 compared with placebo in 14 patients with severe AD. Enrolled patients received five weekly doses of 480 mg of ATI-052 or placebo from weeks 0 through 4, and endpoints for the primary analysis were assessed at day 57. Four patients were excluded from the prespecified per-protocol analysis for reasons defined before unblinding: Two in the

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ATI-052 arm (only two doses taken; eligibility criteria not met) and two in the placebo arm (both began rescue medication early on). Among per-protocol patients in the active arm, 78% had severe disease at baseline, as defined by a score of 4 on the Validated Investigator’s Global Assessment (vIGA), setting a high bar for success.

Primary Analysis Results: AD

Eczema Area and Severity Index (EASI) Score

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Patients treated with ATI-052 experienced a 45% placebo-adjusted mean change in EASI score from baseline at day 57 (absolute change of 58% in the active arm vs 13% in the placebo arm). Responses were durable for the subset of patients with available data at week 16 (follow up ongoing).

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Patients treated with ATI-052 experienced a 78% placebo-adjusted EASI-50 at day 57. Of those, 100% of patients with a baseline severity of vIGA 3 achieved placebo-adjusted EASI-50 at day 57 compared to 71% of patients with a baseline severity of vIGA 4.

Peak Pruritus Numerical Rating Scale (PP-NRS)

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Itch relief emerged in the first week and continued to deepen through week 10 in patients with available data despite high baseline disease severity. At week 4, patients that received ATI-052 experienced a 40% placebo-adjusted a

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