Aclaris Therapeutics (ACRS) Company Report

Aclaris Therapeutics, Inc. reported $167 million in cash, cash equivalents, and marketable securities as of Q3 2025, projecting a cash runway into the second half of 2028.
The company anticipates several key clinical milestones in 2026: Bosakitug (ATI-045) expects top-line results from its Phase 2 Atopic Dermatitis (AD) trial in 2H 2026. For ATI-052, a Phase 1b asthma POC trial initiation is planned for 1Q 2026, with top-line POC results in AD and asthma, and Phase 2b AD trial initiation, all expected in 2H 2026. Additionally, a Phase 2 trial for ATI-2138 in an additional indication (e.g., alopecias) is planned for 1H 2026, with top-line results expected in 2027.
Aclaris is also advancing next-generation therapeutics, with the first IND for its JAK-sparing ITK inhibitor program expected in 2H 2026 and for its multispecific antibody program in 2027.

Jan 12, 2026, 12:00 PM

8-K

Aclaris Therapeutics Announces Positive Interim Results for ATI-052

ACRS

Product Launch

New Projects/Investments

Guidance Update

Aclaris Therapeutics announced positive interim results for its lead bispecific antibody, ATI-052, highlighting its strong safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profile.
ATI-052, which effectively binds both TSLP and IL-4R, demonstrated an effective half-life of at least 26 days, supporting the potential for an extended maintenance dosing interval of up to three months.
The company expects to initiate its first proof-of-concept (POC) trial in atopic dermatitis imminently, followed shortly by a second POC trial in asthma this quarter, with both trials anticipated to read out in the back half of 2026.
Planning is underway to initiate a Phase 2b trial in atopic dermatitis in the second half of 2026 to assess multiple doses and a longer dosing schedule of ATI-052.
ATI-052 exhibited four times greater potency in inhibiting CCL17 production than the combination of Dupilumab and Tezepelamab.

Jan 6, 2026, 1:00 PM

Transcript

Aclaris Therapeutics Reports Positive Interim ATI-052 Phase 1a Trial Results

ACRS

Aclaris Therapeutics announced positive interim results from its ATI-052 Phase 1a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) trial as of December 31, 2025.
The trial demonstrated ATI-052 to be well tolerated with a favorable safety profile across all cohorts up to 720 mg, with no conjunctivitis observed.
The pharmacokinetic profile supports potential for up to every 3-month dosing, and the drug showed robust target engagement and sustained inhibition of inflammatory markers, indicating greater potency than comparator antibodies.
Aclaris plans to initiate a Phase 1b asthma POC trial in Q1 2026 and a Phase 2b AD trial in 2H 2026, with Phase 1b top-line POC results expected in 2H 2026.

Jan 6, 2026, 1:00 PM

Presentation

Aclaris Therapeutics Announces Positive Interim ATI-052 Phase 1a Results and Expedited Clinical Development

ACRS

New Projects/Investments

Guidance Update

Aclaris Therapeutics announced positive interim results from its ATI-052 phase 1a single and multiple ascending dose trial, with results as of December 31, 2025.
ATI-052, a bispecific antibody, demonstrated a strong safety, tolerability, and PK/PD profile, reinforcing its potential for best-in-class potency and an extended dosing schedule of up to three months.
The company plans to expedite the clinical program, initiating Phase 1b proof-of-concept trials for ATI-052 in atopic dermatitis imminently and asthma later this quarter.
A Phase 2b trial in atopic dermatitis is being planned for the second half of 2026 to assess extended maintenance dosing.

Jan 6, 2026, 1:00 PM

Transcript

Aclaris Therapeutics Reports Positive Interim Results for Bispecific Antibody ATI-052

ACRS

New Projects/Investments

Product Launch

Aclaris Therapeutics announced positive interim results from its ATI-052 Phase 1A single and multiple ascending dose trial on January 6, 2026.
The results highlighted ATI-052's strong safety, tolerability, and PK/PD profile, reinforcing its potential best-in-class potency advantage and supporting an extended dosing schedule.
ATI-052, a bispecific antibody, demonstrated an effective half-life of at least 26 days, suggesting the potential for an up to three-month maintenance dosing interval.
The company plans to initiate Phase 1B proof-of-concept trials for ATI-052 in atopic dermatitis imminently and in asthma this quarter, with both expected to read out in the second half of 2026.
A Phase 2B trial in atopic dermatitis is also planned for initiation in the second half of 2026 to assess extended maintenance dosing, supported by these interim results.

Jan 6, 2026, 1:00 PM

Transcript

Aclaris Therapeutics Announces Positive Interim Phase 1a Results for ATI-052

ACRS

New Projects/Investments

Aclaris Therapeutics announced positive interim results from its Phase 1a single and multiple ascending dose trial of ATI-052, an anti-TSLP/IL-4Rα bispecific antibody, on January 6, 2026.
The trial demonstrated a strong safety and tolerability profile and a potential best-in-class pharmacokinetic profile with at least a 26-day effective half-life.
Robust pharmacodynamic activity was observed, supporting the potential for up to every three-month dosing.
The company plans to initiate Phase 1b proof-of-concept trials for ATI-052 in Atopic Dermatitis and asthma in the first quarter of 2026, with top-line data expected in the second half of 2026.
Planning is also underway to initiate a Phase 2b trial in Atopic Dermatitis in the second half of 2026.

Jan 6, 2026, 12:15 PM

8-K

Aclaris Therapeutics Announces Positive Interim Phase 1a Results for ATI-052

ACRS

New Projects/Investments

Aclaris Therapeutics announced positive interim results from its Phase 1a single (SAD) and multiple ascending dose (MAD) trial of its anti-TSLP/IL-4Rα bispecific antibody, ATI-052, on January 6, 2026.
ATI-052 demonstrated a strong safety and tolerability profile, a dose proportional pharmacokinetic profile, and concentration-dependent pharmacodynamics, reinforcing its potential for best-in-class potency and extended dosing of up to every three months.
The company expects to initiate Phase 1b Proof-of-Concept trials in Atopic Dermatitis (AD) and asthma in the first quarter of 2026, with top-line data anticipated in the second half of 2026. Planning is also underway for a Phase 2b trial in AD to begin in the second half of 2026.

Jan 6, 2026, 11:59 AM

Press Release

Aclaris Provides Pipeline Update and Financial Runway

ACRS

New Projects/Investments

Guidance Update

Aclaris is a development-stage biotech company focused on large and small molecule therapeutics, with a pipeline including three clinical-stage assets: O52 (IL-4/TSLP bispecific), a TSLP mAb, and 2138 (ITK JAK3 oral inhibitor).
The company maintains a cash runway into Q3 2028 with $167 million on the balance sheet, managing a quarterly cash burn of $10 million to $13 million.
Significant upcoming milestones include the completion of the O52 bispecific MAD cohort in December 2025, with data expected in early 2026. Data from the TSLP mAb atopic dermatitis study and Phase 2 studies for the O52 bispecific in AD and asthma are anticipated in the second half of 2026.
A Phase 2 study for 2138 in lichen planus is set to begin in early H1 2026, with data projected for early 2027. The company also expects next-gen ITK programs to advance, targeting an IND submission for a JAK-sparing ITK by the end of 2026.

Dec 2, 2025, 4:00 PM

Transcript

Aclaris Provides Pipeline Update and Financial Outlook

ACRS

New Projects/Investments

Guidance Update

Aclaris, a development-stage biotech company, reported a cash runway into Q3 2028 with $167 million on its balance sheet, managing a quarterly cash burn of $10 million to $13 million.
The company's pipeline includes three clinical-stage assets: O52, an IL-4/TSLP bispecific with data expected early 2026; a TSLP mAb (BSI-045B) in atopic dermatitis, with data anticipated in H2 2026; and 2138, an ITK JAK3 oral inhibitor, with a phase 2 study in lichen planus starting early 2026 and data expected early 2027.
Aclaris is also developing next-gen ITK programs, which are expected to enter the clinic in late 2026.

Dec 2, 2025, 4:00 PM

Transcript

Aclaris Outlines Development Pipeline and Upcoming Data Readouts

ACRS

New Projects/Investments

Guidance Update

Aclaris (ACRS) is a development-stage biotech company focused on large and small molecule therapeutics, reporting a cash runway into Q3 2028 with $167 million on its balance sheet and a quarterly cash burn of approximately $10 million-$13 million.
The company expects data from its TSLP mAb program in moderate-to-severe atopic dermatitis and its TSLP IL-4 bispecific program in atopic dermatitis and asthma in the second half of 2026.
Enrollment for the phase II study of ATI-2138, an ITK JAK3 oral inhibitor, in lichen planus is anticipated to commence in the early first half of 2026, with data projected for early 2027.