Ankündigung • Apr 30

Aclaris Therapeutics Announces Positive Full Top Line First-In-Human Results from Phase 1A Healthy Volunteer Clinical Trial of ATI-052 and Lichen Planus as Lead Indication for ATI-2138

Aclaris Therapeutics, Inc. provided a clinical update on its biologic and oral inhibitor compounds including positive full top line results from the first-in-human Phase 1a single (SAD) and multiple ascending dose (MAD) trial of its anti-TSLP/IL-4Ra bispecific antibody ATI-052 and the selection of lichen planus (LP) as the lead indication for its selective ITK/JAK3 inhibitor ATI-2138. Positive full results from Phase 1a trial of anti-TSLP/IL-4Ra bispecific antibody ATI-052 exceed Aclaris’ target profile, validating potential best-in-class potency advantage and opportunity for extended dosing. Estimated half-life of approximately 45 days; unlocks opportunity for up to three-month dosing interval. Complete and sustained inhibition of TSLP-induced and IL-4 induced CCL17 (TARC) provides potential to raise efficacy ceiling in Th2-driven diseases. Enrollment and dosing ongoing in Phase 1b trials in asthma and atopic dermatitis (AD) with top line results expected in the second half of 2026. Lichen planus selected as lead indication for ATI-2138; potential to be first mechanistically complete therapeutic candidate designed to address root inflammation and symptoms. ATI-052 is an investigational anti-TSLP and anti-IL-4Ra bispecific antibody that exhibits high binding affinity to, and dual blockade of, both the TSLP receptor signal transduction and downstream IL-4Ra activation thereby inhibiting this central proinflammatory pathway. By addressing the shared receptor IL-4Ra, ATI-052 blocks IL-4 and IL-13 biological activity, key cytokines driving Th2 inflammation. ATI-052 exhibited a potential best-in-class pharmacokinetic (PK) profile, including an estimated half-life of approximately 45 days. Dose proportional PK was observed across the pharmacologic dose range, including dose proportional increases in Cmax (maximum peak concentration) and AUC (area under the curve; a measure representing total systemic exposure). Pharmacodynamic (PD) results validate the potency of ATI-052, including robust target engagement and near complete target occupancy. ATI-052 demonstrated complete and sustained inhibition through at least week 20 (four months post last dose) of ex vivo TSLP stimulated CCL17/TARC and at least week 12 (two months post last dose) of ex vivo IL-4 stimulated CCL17/TARC in the 480 mg MAD cohort. The combination of the strong and sustained PK duration and PD effect supports the potential for up to every three-month dosing. No impact of anti-drug antibodies (ADA) on PK or PD has been observed in this trial. ATI-052 was well tolerated and demonstrated a favorable safety profile across all SAD and MAD cohorts, consistent with the interim results; no safety signals including conjunctivitis were observed. The randomized, blinded, placebo-controlled Phase 1a portion of the first-in-human study was designed to evaluate the safety, tolerability, PK, and PD of subcutaneously administered ATI-052 in healthy adults receiving SAD and MAD doses. In the SAD portion, four cohorts of 8 healthy volunteers each were randomized 3:1 to receive a single dose of ATI-052 (30, 120, 360, or 720 mg) or placebo. In the MAD portion, two cohorts of 8 healthy volunteers each were randomized 3:1 to receive five doses of two dose levels of ATI-052 (240 or 480 mg) or placebo administered every 7 days. Participants were followed for safety for approximately 16 weeks for the SAD cohorts and 20 weeks for the MAD cohorts. In January 2026, Aclaris announced the initiation of a Phase 1b proof-of-concept (POC) trial in patients with atopic dermatitis (EASI >21). In February 2026, the Company initiated a Phase 1b POC trial in patients with asthma on GINA (Global Initiative for Asthma) steps 2-4 treatment prior to screening. Enrollment is ongoing in both trials, and top line results from both are expected in the second half of 2026. Given the results observed to date and its mechanism of action targeting TSLP as well as effects of IL-4 and IL-13 through blockade of the shared receptor IL-4Ra, the Company announced its intent to initiate a Phase 2b program with ATI-052, initially targeting asthma, in the fourth quarter of 2026. ATI-2138 is a highly potent and selective novel investigational pharmacologic agent that acts as a dual inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3); the dual mechanism enables deep suppression of pathogenic T-cells via inhibition of TCR signaling and effector cytokine activation. Aclaris intends to initiate a phased multi-part Phase 2b basket study of ATI-2138 in lichen planus (LP), an unaddressed chronic, inflammatory, CD8+/Th1-driven interface dermatitis impacting approximately 0.1% to 1.0% of the population. The trial is expected to comprise the three most common LP subtypes: erosive mucosal, cutaneous, and lichen planopilaris (LPP), a rare form of LP that causes permanent hair loss. The most common symptoms of LP include sores, pain, difficulty eating, severe itch, scales/plaques, hair loss, and fatigue; quality of life is also affected in most patients, including due to anxiety and depression. There is also the potential for malignancy in certain subtypes. Disease management has focused on immunosuppression and symptom control; there are currently no FDA-approved therapies. Despite the lack of therapeutic options, approximately 40% of patients seek treatment. An oral agent like ATI-2138 has the potential to provide rapid symptom and itch relief and address multi-site (cutaneous, oral, and scalp) disease involvement. The Company estimates that the potential market opportunity in the U.S. for an oral therapeutic for LP exceeds $1.0 billion with opportunity up to $4.0 billion. Aclaris expects to initiate Part A (erosive mucosal; cutaneous) of this trial in the second half of 2026 and intends to move into Part B (LPP) soon thereafter. ATI-052 is an investigational humanized anti-TSLP and anti-IL-4Ra bispecific antibody that exhibits high binding affinity to and dual blockade of both the upstream thymic stromal lymphopoietin (TSLP) receptor signal transduction and downstream interleukin-4 receptor (IL-4R) activation thereby inhibiting this central proinflammatory pathway. ATI-052 targets TSLP, which sits at the top of the inflammatory cascade; by targeting IL-4Ra, it blocks both downstream IL-4 and IL-13, which are key cytokines involved in Th2-mediated inflammation and allergic diseases. ATI-052 exhibits potential best-in-class potency and utilizes the same TSLP antigen-binding fragment (Fab) region as bosakitug (ATI-045), retaining the dissociation kinetics, long residence time, and high potency advantages over comparator antibodies, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life.

Ankündigung • Jan 10

Aclaris Therapeutics, Inc. Announces Top-line Results from 4-Week Phase 2b Trial of ATI-1777 for Mild to Severe Atopic Dermatitis

Aclaris Therapeutics, Inc. announced top-line results from its Phase 2b study of ATI-1777, an investigational topical “soft” JAK 1/3 inhibitor, in patients with mild to severe atopic dermatitis (AD) (ATI-1777-AD-202; NCT05432596). ATI-1777 was generated from Aclaris’ proprietary KINect® drug discovery platform. ATI-1777-AD-202 was a Phase 2b, multicenter, randomized, double-blind, vehicle-controlled, parallel-group clinical trial to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple concentrations (0.5%, 1% and 2%) of twice daily treatment with ATI-1777 and a single concentration (2%) of once daily treatment with ATI-1777. For this trial, ATI-1777 was developed as an emollient-containing spray formulation. The trial randomized 250 patients with mild, moderate or severe AD, including adults and children as young as 12 years old, across 30 clinical trial sites in the United States. Results: The trial met the primary efficacy endpoint, the percent change from baseline in the Eczema Area and Severity Index (EASI) score at week 4, with statistical significance for patients treated with ATI-1777 2% BID compared to patients treated with vehicle (69.7% versus 58.7% in the pooled vehicle group, p=0.035). In addition, the following results were observed with respect to the primary endpoint: While not statistically superior, ATI-1777 2% QD showed a trend toward significance (68.3% compared to 59.5% in vehicle, p=0.086); In the per-protocol population, or all patients who had week 4 data with no major protocol deviations, ATI-1777 2% BID demonstrated a 70.8% reduction in EASI compared to a 58.5% reduction in vehicle (p=0.025), and ATI-1777 2% QD demonstrated a 68.4% reduction in EASI compared to a 59.7% reduction in vehicle (p=0.102); In addition, a post-hoc analysis of only patients who had baseline severity of moderate or severe AD showed a 65.6% and 65.1% reduction in the EASI score at week 4 in ATI-1777 2% BID and ATI-1777 2% QD, respectively, compared to a 52.6% reduction in the pooled vehicle group (p=0.029 and 0.040, respectively). While not statistically powered, ATI-1777 2% BID and 2% QD also showed improvement in the proportion of patients who reached an IGA-TS response (Investigator Global Assessment Treatment Success, the U.S. FDA regulatory endpoint) at week 4 (ATI-1777 2% BID: 37.2% compared to 27.1% in vehicle, p=0.141; ATI-1777 2% QD: 36.6% compared to 26.3% in vehicle, p=0.137). The per-protocol population demonstrated an IGA-TS response at week 4 of 41.8% for ATI-1777 2% BID compared to 25.5% in vehicle (p=0.059) and 39.8% for ATI-1777 2% QD compared to 25.4% in vehicle (p=0.079). A PK analysis showed minimal levels of exposure to ATI-1777. The mean steady state trough drug levels at week 4 were 0.319 ng/mL, representing 0.7% of IC for JAK 1/3 inhibition in whole blood. In total, 97% of ATI-1777 plasma samples from dosed patients had concentrations below 1/10th of the IC, and six samples (from five ATI-1777-treated patients) of 570 samples analyzed had concentrations above 1/4 of the IC. No meaningful safety findings were observed and ATI-1777 was well tolerated. In particular, no adverse events (AEs) commonly associated with JAK inhibitors, including serious infections, malignancies, major adverse cardiovascular events (MACE) and thromboses, were observed in patients treated with ATI-1777. The most common AEs in patients treated with ATI-1777 (reported in =2% patients) were nasopharyngitis (ATI-1777: 2%; vehicle: 2%) and application site itch (ATI-1777: 2.5%; vehicle: 0%). Among patients receiving ATI-1777, there were no discontinuations due to AEs and one serious but unrelated AE in a patient (ATI-1777 2% QD) who completed the study. All other AEs were mild to moderate in severity.

Gesamte Aktionärsrendite	-9.5%
Zukünftige Dividendenrendite	n/a
Wachstum der Dividende	n/a
Nächster Dividendenzahlungstermin	n/a
Ex-Dividendendatum	n/a
Dividende pro Aktie	n/a
Ausschüttungsquote	n/a

Segment	Dividendenrendite
Unternehmen (ACRS)	n/a
Untere 25 % des Marktes (US)	1.4%
Markt Top 25 % (US)	4.2%
Branchendurchschnitt (Pharmaceuticals)	2.0%
Analystenprognose (ACRS) (bis zu 3 Jahre)	n/a

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/06/09 21:14
Aktienkurs zum Tagesende	2026/06/09 00:00
Gewinne	2026/03/31
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
Prakhar Agrawal	Cantor Fitzgerald & Co.
Donald Ellis	Citizens JMP Securities, LLC
Adam Vogel	Craig-Hallum Capital Group LLC

Aclaris Therapeutics Ausschüttungen und Rückkäufe

Zukünftiges Wachstum Kriterienprüfungen 0/6

Wichtige Informationen

Jüngste Updates zu Dividenden und Rückkäufen

Recent updates

Consensus revenue estimates increase by 14%

First quarter 2026 earnings released: US$0.15 loss per share (vs US$0.12 loss in 1Q 2025)

Price target increased by 11% to US$9.44

Aclaris Therapeutics Announces Positive Full Top Line First-In-Human Results from Phase 1A Healthy Volunteer Clinical Trial of ATI-052 and Lichen Planus as Lead Indication for ATI-2138

Aclaris Therapeutics, Inc., Annual General Meeting, Jun 04, 2026

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Aclaris Therapeutics, Inc. Completes Enrollment In Phase 2 Trial Of Bosakitug (ATI-045) In Atopic Dermatitis

New minor risk - Shareholder dilution

Consensus revenue estimates fall by 37%

Full year 2025 earnings: EPS in line with expectations, revenues disappoint

Aclaris Therapeutics, Inc. Initiates Phase 1B Proof-Of-Concept Trial in Patients with Asthma with Its Novel Bispecific Anti-Tslp/Il-4Ra Antibody Ati-052

New major risk - Revenue and earnings growth

Co-Founder exercised options and sold US$65k worth of stock

There's Reason For Concern Over Aclaris Therapeutics, Inc.'s (NASDAQ:ACRS) Massive 25% Price Jump

Aclaris Therapeutics' Novel ITK/JAK3 Inhibitor ATI-2138 Demonstrates Rapid and Sustained Hair Regrowth in Validated Murine Model of Alopecia Areata (AA)

New major risk - Share price stability

Aclaris Therapeutics, Inc. Initiates Phase 1b Proof-Of-Concept Trial in Atopic Dermatitis (AD) with Its Novel Bispecific Antibody ATI-052

Chief Business Officer exercised options and sold US$120k worth of stock

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New major risk - Revenue and earnings growth

Consensus revenue estimates increase by 52%

Third quarter 2025 earnings released: US$0.12 loss per share (vs US$0.11 loss in 3Q 2024)

Revenues Not Telling The Story For Aclaris Therapeutics, Inc. (NASDAQ:ACRS) After Shares Rise 31%

Consensus revenue estimates fall by 16%

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Earnings Update: Aclaris Therapeutics, Inc. (NASDAQ:ACRS) Just Reported And Analysts Are Boosting Their Estimates

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Consensus revenue estimates decrease by 57%, EPS upgraded

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Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of Its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody

Aclaris Therapeutics, Inc., Annual General Meeting, Jun 05, 2025

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New major risk - Revenue and earnings growth

Consensus EPS estimates fall by 13%

Chief Scientific Officer exercised options and sold US$54k worth of stock

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Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind

Aclaris Therapeutics, Inc. Announces New Publication Highlights Unique Properties of ATI-2138, A Potent and Selective Inhibitor of ITK and JAK3

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New major risk - Revenue and earnings growth

Aclaris Therapeutics, Inc. Announces Formation of New Scientific Advisory Board

Chief Business Officer exercised options and sold US$101k worth of stock

Price target increased by 32% to US$10.00

Consensus EPS estimates fall by 10%

New major risk - Shareholder dilution

Co-Founder exercised options and sold US$153k worth of stock

Aclaris Therapeutics, Inc. announced that it has received $79.999999 million in funding from a group of investors

New major risk - Shareholder dilution

Consensus EPS estimates fall by 20%

Aclaris Therapeutics, Inc. Announces Executive Appointments

Consensus revenue estimates decrease by 17%, EPS upgraded

Analysts Are Betting On Aclaris Therapeutics, Inc. (NASDAQ:ACRS) With A Big Upgrade This Week

Third quarter 2024 earnings: EPS and revenues miss analyst expectations

Consensus revenue estimates increase by 67%

Second quarter 2024 earnings: EPS and revenues exceed analyst expectations

Is Aclaris Therapeutics (NASDAQ:ACRS) In A Good Position To Invest In Growth?

Price target decreased by 14% to US$1.55

Aclaris Therapeutics, Inc.(NasdaqGS:ACRS) dropped from Russell 3000 Growth Index

Consensus revenue estimates increase by 37%

First quarter 2024 earnings: EPS and revenues exceed analyst expectations

We're Keeping An Eye On Aclaris Therapeutics' (NASDAQ:ACRS) Cash Burn Rate

Aclaris Therapeutics, Inc. to Report Q1, 2024 Results on May 07, 2024

Aclaris Therapeutics, Inc., Annual General Meeting, Jun 06, 2024

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Analysts Have Been Trimming Their Aclaris Therapeutics, Inc. (NASDAQ:ACRS) Price Target After Its Latest Report

Aclaris Therapeutics, Inc. Announces Intangible Asset Impairment for the Three Months Ended December 31, 2023