Form 8-K

8-K — Aclaris Therapeutics, Inc.

Accession: 0001104659-26-049733

Filed: 2026-04-28

Period: 2026-04-28

CIK: 0001557746

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — acrs-20260428x8k.htm (Primary)

EX-99.1 (acrs-20260428xex99d1.htm)

EX-99.2 (acrs-20260428xex99d2.htm)

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8-K

8-K (Primary)

Filename: acrs-20260428x8k.htm · Sequence: 1

Aclaris Therapeutics, Inc._April 28, 2026

0001557746false00015577462026-04-282026-04-28

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 28, 2026

Aclaris Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-37581

46-0571712

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

701 Lee Road, Suite 103

Wayne, PA 19087

(Address of principal executive offices, including zip code)

(484) 324-7933

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class:

Trading Symbol(s)

Name of Each Exchange on which Registered

Common Stock, $0.00001 par value

ACRS

The Nasdaq Stock Market, LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On April 28, 2026, Aclaris Therapeutics, Inc. (the “Company”) will hold a conference call to discuss the 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-4Rα bispecific antibody ATI-052 and the selection of lichen planus (LP) as the lead indication for its selective ITK/JAK3 inhibitor ATI-2138 (the “ATI-052 Results & ATI-2138 Trial”). A copy of the presentation that will accompany the conference call is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On April 28, 2026, the Company issued a press release announcing the ATI-052 Results & ATI-2138 Trial. A copy of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

Exhibit Description

99.1

Company Presentation, dated April 28, 2026.

99.2

Press Release, dated April 28, 2026.

104

The cover page from Aclaris Therapeutics, Inc.’s Form 8-K filed on April 28, 2026, formatted in Inline XBRL.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ACLARIS THERAPEUTICS, INC.

By:

/s/ Kevin Balthaser

Date: April 28, 2026

Kevin Balthaser

Chief Financial Officer

EX-99.1

Filename: acrs-20260428xex99d1.htm · Sequence: 2

Exhibit 99.1

Clinical Pipeline Update:

ATI-052: Full SAD MAD Results

ATI-2138: Potential Mechanistically

Complete Therapy for Lichen Planus

April 28, 2026

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is

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 its development plans for ATI-052 and ATI-2138, including the timing to report results

from its Phase 1b trials of ATI-052 in asthma and atopic dermatitis, the timing to initiate a Phase 2b trial of ATI-052 in asthma, and the timing and

plans to initiate a Phase 2b basket study of ATI-2138 in LP, the therapeutic potential for ATI-052 and ATI-2138, including the potential for ATI-052

to be best-in-class, and the potential for ATI-052 to support dosing of up to three months, and the potential for ATI-052 to treat atopic,

immunologic, and respiratory diseases and ATI-2138 to treat atopic and autoimmune diseases. These statements involve risks and uncertainties

that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results

to differ materially include uncertainties inherent in the conduct of clinical trials, 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, the uncertainty regarding the

macroeconomic environment and other risks and uncertainties that are 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 (the “SEC”)

from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at

www.aclaristx.com. 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, and 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.

Tradenames, trademarks and service marks of other companies appearing in this presentation are the property of their respective owners.

This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and other

data about our industry. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such

estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which

we operate are necessarily subject to a high degree of uncertainty and risk.

All future development, clinical, and regulatory timelines are expectations, are based on current beliefs and assumptions, and are subject to

change based on a variety of factors.

Disclaimer and Cautionary Note Regarding

Forward-Looking Statements

Addressing Significant Markets

Th2 Driven Indications

Sources: Eczema stats: National Eczema Association (accessed 07/31/25); Precedence Research; Forbes Business Insights; American Medical Association; American Lung Association; Global

Initiative for Asthma; World Health Organization; The Centers for Disease Control and Prevention (CDC); Business Research Company; peer research; Delveinsight; Cowen Categories Outlook 2024

Purigo

nodularis

Chronis

spontaneous

urticaria

Eosinophilic

esophagitis

COPD Asthma Atopic

dermatitis

Total Addressable Market (TAM)

Global, 2028-2034

($ billion)

Significant opportunity for new innovative biologics targeting

indications with heterogeneous subtypes

Opportunity to Redefine the Standard in Th2 Disease

• ATI-052: Harnesses the power of TSLP and IL-4R inhibition to create a potential best-in-class bispecific

• Tezepelumab and Dupilumab drive multibillion dollar annual revenues across numerous indications

• Combining mechanisms has the potential to better address the unmet needs across approved

indications

• Potential opportunities for ATI-052

• Potential first line therapy

• Raise efficacy ceiling

• Inhibition upstream and downstream of Th2 cascade

• Faster onset, better symptom control, durable, deeper, and more consistent effect

• Better address breadth of inflammatory mediators involved in Th2 diseases

• Improved convenience and practical dosing schedule

• Potential Q3 month dosing

ATI-052: Potential Best-in-Class Bispecific mAb

Effective Dual Binding of TSLP and IL-4Rα

ATI-052 CH2 CH3 CH2 CH3

Same anti-TSLP antibody binding

regions of Bosakitug, designed to

inhibit TSLP upstream of the Th2

cascade

• Retains dissociation kinetics,

residence time, and potency

advantages of bosakitug over

comparator antibodies

Designed to inhibit immune cells

downstream of the Th2 cascade

Anti-TSLP Fab

Anti-IL4Rα scFV

Fc engineered to bind more

tightly to FcRn, potentially

extending half-life

YTE Mutation

Fc mutation limits effector

functionality, potentially reducing

off-target binding and potential

toxicity

AQQ Mutation

Dissociation of TSLP from mAbs (TR-FRET)

0 1000 2000 3000 4000 0.0

0.5

1.0

Time (min)

Fractional Response (yi/yo

)

ATI-045 ATI-052 GSK-5784283 V1 (hu3-13)* GSK-5784283 V2 (hu179-33)* Solrikitug/MK-8226** Tezepelumab**

Residence Time

(hours)

416 402

14.3 8.11 22.1 3.59 20.7

ATI-052

ATI-045

Tezepelumab**

Solrikitug/MK-8226**

GSK-5784283 V2 (hu179-

33)*

GSK-5784283 V1 (hu3-13)*

UPB-101

TSLPR1

(n=2)

TSLP

(n=3)

bosakitug

ATI-052 demonstrates very slow dissociation kinetics from TSLP

Residence time for ATI-052 is ~30-116x longer than comparator antibodies

ATI-052: Longest Residence Time on TSLP

Lower Dissociation Rate Drives Longer Residence Time

1. SPR: Residence Time based on apparent kd (dissociation constant) using standard TSLPR immobilization density and bivalent fit; *Analog

mAb; **Biosimilar mAb

bosakitug

ATI-052

Bosakitug Extensively Binds TSLP Binding Interface

ATI-052 Has the Same Anti-TSLP Antibody Binding Regions of Bosakitug

Only Bosakitug binds all six Light Chain and Heavy Chain CDRs

Bosakitug interface uniquely spans from TSLP N-terminal Y29 to C-terminal P154

Tezepelumab Bosakitug (ATI-045)

Bosakitug: Extensive Binding Interface Drives Higher Retention Time and Neutralization Duration of TSLP

Concurrent Binding of TSLP and sIL-4R to ATI-052

Simultaneous Binding of TSLP and IL-4R

ATI-052

Demonstrates

High Affinity to

Both Targets

Simultaneously:

ATI-052 binds

~two molecules

of TSLP and

sIL-4R with the

potential to

saturate all 4

binding sites at

the same time

TSLP:ATI-052 sIL-4Ra:ATI-052

Binding Sequence Stoichiometry* Stoichiometry*

ATI-052 capture / sIL-4Ra dose-response n/a 2.25

ATI-052 capture / TSLP load / sIL-4Ra dose-response 1.83 2.10

ATI-052 capture / TSLP dose-response 2.04 n/a

ATI-052 capture / sIL-4Ra load / TSLP dose-response 1.83 1.97

* determined using molecular weights based on amino acid sequence, does not account for glycosylated species

• ~2 molecules of sIL-4R bound to ATI-052 in the absence (2.25:1) and

presence (2.10:1) of TSLP

• ~2 molecules of TSLP bound to ATI-052 in the absence (2.04:1) and

presence (1.82:1) of sIL-4R

Concurrent Binding of TSLP and sIL-4R to ATI-052

High Affinity to Both TSLP and IL-4R

ATI-052 Binds

Both Targets

Effectively

High affinity to

either target is

not altered by

the binding to

the other

Comparison of Affinity for sIL-4R Binding to

ATI-052 or ATI-052:TSLP Complex

Comparison of Affinity for TSLP Binding to

ATI-052 or ATI-052:sIL-4R Complex

Parameter ATI-052 ATI-052:TSLP

(pM) 348 215

Parameter ATI-052 ATI-052:sIL-4R

(pM) 41.2 33.9

Comparison of ATI-052 vs Dupilumab + Tezepelumab

ATI-052 Demonstrates Greater Potency than the mAb Combination

ATI-052 is Substantially More Potent than the Combination

of Dupilumab and Tezepelumab

mAb Concentration

Antibody IC50 (nM)

ATI-052 0.016

Dupilumab +

Tezepelumab 0.069

Fold change 4.3

ATI-052 Placebo Controlled Phase 1a Program

Cohort 1 (30mg): SC, N=8 D1-113

Screening Randomization

3:1 Cohort 3 (360mg): SC, N=8 D1-113

Cohort 4 (720mg): SC, N=8 D1-113

Cohort 2 (120mg): SC, N=8 D1-113

Part A Single Ascending Dose (SAD) in Healthy Volunteers (HV)

Part B Multiple Ascending Dose (MAD) in Healthy Volunteers

Screening Randomization

3:1

D1 D8 D15 D22 D29

D1 D8 D15 D22 D29 D141

D141

Cohort 1 (240mg): SC, N=8 Q7D x 5 Doses

Cohort 2 (480mg): SC, N=8 Q7D x 5 Doses

Treatment and Follow-up Period

Potential Best-in-Class Pharmacokinetic Profile

Supports Potential for Up to Every 3-Month Dosing

Dose proportional PK

observed across

pharmacologic dose

range

PK results provided an

estimated half-life of

45 days1

MAD Cohort 1 (240 mg)

MAD Cohort 2 (480 mg)

SAD Cohort 1 (30 mg)

SAD Cohort 2 (120 mg)

SAD Cohort 3 (360 mg)

SAD Cohort 4 (720mg)

1, Based on accumulation ratio at 240 mg weekly dosing

Ex-Vivo Stimulated PD Assay

High Hurdle for Complete Inhibition

Robust PD activity ex vivo hWB closely

reflects the real biological environment in

patients with disease by maintaining the

complex composition of fluids and cells

present in circulation

• Assay in human whole blood (hWB)

designed to assess the following:

o TSLP stimulated CCL17 in whole blood

o IL-4 stimulated CCL17 in whole blood

• hWB assay sets high biological bar:

Assesses inhibition of up to 500-fold more

TSLP and IL-4 than endogenous levels

hWB Assays

0.0001

0.001

0.01

0.1

CCL17 release (% pos ctrl)

100

120

140

[ATI-052] nM

IC50 (nM)

± SEM

0.025

±0.0042

n 5

S/N 3

IC50 (nM)

± SEM

0.203

±0.039

n 6

S/N 15

0.5 ng/mL TSLP stimulation—48 hours 2 ng/mL IL-4 stimulation—48 hours

5 ng/ml*

41 ng/ml

0.0001

0.001

0.01

0.1

CCL17 release (% pos ctrl - unstim)

100

[ATI-052] nM

*IC50 for the inhibition of TSLP-stimulated CCL17 in whole blood

was lower than the Lower Limit Of

Quantitation (LLOQ) for the PK

analysis of ATI-052 (LLOQ is 25 ng/ml) 13

Potential Best-in-Class Pharmacodynamic Effect of ATI-052

ATI-052 binds both targets

effectively

with complete inhibition at

pharmacologically

relevant doses beyond the

PK profile

Sustained complete

inhibition observed for

at least three months

at 480 mg MAD dose

IL-4 Stimulated

CCL17 (TARC):

Evidence of sustained

inhibition of TSLP

corroborate long

residence time

The combination of PK

duration and the strong

and sustained PD effect

support the potential for up

to every three-month

dosing

MAD Cohort 1 (240 mg)

MAD Cohort 2 (480 mg)

CCL17 Production (% Predose, Mean

Weeks

±SEM)

Sustained, complete /

near complete inhibition

observed for

at least five months at 240

and 480 mg MAD dose

Potential best-in-class

residence time and

potency

TSLP Stimulated

CCL17 (TARC):

CCL17 Production (% Predose, Mean

±SEM)

SAD Cohort 1 (30 mg)

SAD Cohort 2 (120 mg)

SAD Cohort 3 (360 mg)

SAD Cohort 4 (720mg)

Placebo

Weeks

Note: No samples taken at weeks 8, 10, 14 and 18

Exceptional Pharmacodynamic Response

Robust Target Engagement + Sustained Complete Inhibition in MAD Cohorts

ATI-052 exhibited a potential best-in-class PD profile:

• Dose and concentration dependent inhibition of IL-4 and TSLP-stimulated

CCL17 (TARC) release observed across all SAD and MAD cohorts

• Near complete inhibition of TSLP stimulated CCL17 observed for at least

5 months in 240 mg MAD Cohort

• Complete inhibition of TSLP stimulated CCL17 observed for at least 5 months

in 480 mg MAD Cohort

• 480 mg MAD Cohort results demonstrated complete and sustained inhibition

of IL-4 stimulated CCL17 for at least three months

• PK/PD package support the potential to raise the efficacy ceiling and an

extended dosing schedule of up to every three months

Observed

inhibitory

results

further

validate the

potency of

ATI-052

Favorable Tolerability and Safety Profile of ATI-052

Update Provides Confidence in Continued Development

• Low rate of drug related treatment emergent adverse

events; predominantly Grade 1

• No SAEs; no adverse events led to study discontinuation

• No Grade 3 drug-related TEAEs

• No conjunctivitis

Full results confirm

strong safety profile

observed at interim

analysis

Favorable tolerability

and safety profile

demonstrated across

all ATI-052 SAD and

MAD cohorts

Screening/

Washout

Randomization

3:1 Active

to Placebo

Primary Endpoint Safety and tolerability

Phase 1b POC Trial in Atopic Dermatitis

Enrollment and Dosing Ongoing

12 AD Patients

EASI >21

Placebo Q1wk (five doses)

ATI-052 Q1wk (five doses, 480 mg)

12-week follow-up

Day 57

Top Line Readout

Primary Endpoint Safety and tolerability

Phase 1b POC Trial in Asthma

Enrollment and Dosing Ongoing

16 Patients

GINA steps 2-4 prior

Other endpoints Key Clinical Efficacy Assessment Emphasis on PD assessments: FeNO, FEV1, Blood Eos,

TARC (CCL17), Periostin, IGE, Cytokines (IL-4,IL-5,IL-13)

Patient Selection

Adult asthmatics on GINA steps

2-4 treatment prior to screening;

excluding prior biologics

Type 2 asthma with active inflammation:

FeNO baseline ≥ 25-35 ppb, Blood Eos ≥ 150

ATI-052: Next Steps

Positive SAD/MAD Results Validate ATI-052; Clinical Program Rapidly Advancing

Ongoing / Next Steps

• Phase 1b Asthma and AD POC

trials ongoing; dosing underway

• Phase 1b top line POC results:

2H 2026

• Initiate Phase 2b program

(initial target = asthma): 4Q 2026

Phase 1

HV: SAD/MAD

Phase 1b POC

Atopic dermatitis

Phase 1b POC

Asthma

Dosing

ongoing

Complete

Dosing

ongoing

Initiation

4Q 2026

Phase 2b

program

Asthma

Atopic dermatitis

Potential Phase 2b

Targets

(other non-dermatology)

COPD

EOE

Potential Phase 2b

Targets

(dermatology)

Prurigo Nodularis (PN)

Chronic Spontaneous

Urticaria (CSU)

All future development, clinical, and regulatory timelines are expectations, are based on current beliefs and assumptions, and are subject to change based on a variety of factors

Clinical Pipeline Update:

ATI-2138: Potential Mechanistically

Complete Therapy for Lichen Planus

Mechanistically well matched

JAK3 and cyclosporin provide POC

Important unmet medical need:

White space opportunity

Significant market size

and revenue potential

Potential for cost-effective

clinical trial design

Regulatory pathways may

allow for expedited review

ATI-2138: The Lichen Planus Opportunity

Lichen planus

Typical symptoms are debilitating

Include pain, sores, severe itch, scales/plaques, hair loss, fatigue

Multiple impactful clinical subtypes

Most common are erosive mucosal (oral), cutaneous,

and lichen planopilaris

Affects quality of life

Anxiety, depression; impact from chronic pain

and severe itch

Clinically concerning

Malignant potential in oral lichen planus

Lichen Planus

An Unaddressed Chronic, Inflammatory, Immune-Mediated Disorder

Lichen

Planus

Prevalence suggests large opportunity

Impacts 0.1% to 1.0% of the population

Lichen Planus is a Large and Unsatisfied Market

Significant “White Space” US Opportunity

• Prevalence of between 0.1% and 1.0% of the population

– Up to 40% of patients seek treatment despite no FDA-approved targeted therapeutic interventions

– ~25% of patients have moderate-to-severe disease

• Steroid failure rate of up to 60%

• No approved therapy; unsatisfied market

– Disease management has focused on immunosuppression and topical symptom control

(TCS, tacrolimus, etc.)

• Opportunity for biologics-like pricing

• New, targeted therapeutics have the potential to:

– Increase diagnosis rates and % of patients seeking Tx

– Provide rapid itch relief; minimize flares

– Address multi-site disease involvement

– Provide more practical Tx than topical for widespread lesions

Estimated Peak U.S. revenue potential: $1B - $4B

Modified from Giles JR et al., Immunity, 2023

ATI-2138: Unique “Bispecific-Like” Mechanism

First & Only Known Drug Inhibiting TCR Activation Upstream + Effector Cytokines Downstream

Inhibition of T Cell Receptor (TCR)

Signaling (Antigen-Driven; Signal 1)

• Potent inhibition of ITK downstream of

the TCR inhibits auto-antigen and

allergen mediated T cell activation

• Inhibits cytotoxic destruction of targets

by CD8 T cells

• Inhibits production of inflammatory

cytokines (IFN-y, IL-4, IL-13, IL-17, IL-31)

Other JAK inhibitors do not inhibit

TCR activation

Inhibition of Cytokine Signaling

(Cytokine-Driven; Signal 3)

• Potent inhibition of JAK3

downstream of the IL-2 receptor

common γ chain inhibits IL-2, IL-4, IL-7, IL-9, IL-15 and IL-21

signaling

• Inhibits T cell proliferation,

activation and survival

• Inhibits cytotoxic activity of CD8

T-cells and Natural Killer cells

(NK-cells)

T cell

ITK Inhibition

JAK3 Inhibition

ATI-2138 Has the Potential to Be The First

Mechanistically Complete Oral Therapy for Lichen Planus

ATI-2138: Well Positioned in Lichen Planus

Dual Pharmacology Creates Ideal Mechanistic Fit

• CD8-driven interface dermatitis;

involvement of TCR/T cells

• Aberrant activation cytotoxic CD8 T cells

• IFN mediated pathology in affected skin

• Modulates TCR signaling and CD8 cytotoxic

T cell suppression

• Inhibition of IFNy production biomarkers

down-stream of IFNy

Lichen planus ATI-2138

Signal 1

Antigen

Signal 3

Cytokine

Efficacy of calcineurin inhibitors in LP

supports T-cell mediated pathology; JAK3

and cyclosporin provide additional POC

Potential for broad/deep efficacy in LP;

may address root inflammation and

symptomology

• Cytokine mediated disorder; severe itch

associated with IL-31 up-regulation

• Fibrosis common

• Th1/2/17 immunology

• Inhibits proinflammatory cytokines; significant

reductions in itch observed in AD

• Strong downregulation of fibrosis markers

• Downregulation of Th1/2/17 activation markers

ATI-2138: Next Steps

Mechanistically Fit for Lichen Planus and Other I&I Disorders

Ongoing / Next Steps

• Lichen planus selected as

Phase 2b indication

• Initiate Phase 2b trial in

2H 2026

• Complete assessment of

additional targets

Phase 2a

Atopic Dermatitis

Complete

Initiation

2H 2026

Potential Future

Targets

Uncontrolled asthma

Alopecia areata

Vitiligo

Phase 2b

program

Lichen planus

Mucosal

Cutaneous

LPP

Severe Hair Loss

(murine)

Alopecia universalis

Complete

All future development, clinical, and regulatory timelines are expectations, are based on current beliefs and assumptions, and are subject to change based on a variety of factors

ATI-052 SAD/MAD Results Exceeded Expectations

• Well tolerated with a favorable safety profile across SAD and MAD cohorts

• No conjunctivitis

Favorable

Tolerability and Safety

Profile

Pharmacokinetic Profile

Supports Potential for

Extended Dosing

Strong Pharmacodynamic

Response

Efficient Inhibition of Both

TSLP and IL-4Rα

• Dose proportional PK observed across pharmacologic dose range

• Linear half-life exceeds prior estimate of 26 days

• Robust target engagement + complete/near complete target occupancy

• Complete and sustained inhibition of ex vivo IL-4 or TSLP stimulated CCL17

• Results support potential for up to every 3-month dosing interval

• Potential to raise the efficacy ceiling

ATI-2138 May be Ideal Therapy for Lichen Planus

• First and only known drug inhibiting TCR activation upstream + effector

cytokines downstream

• Observed in AD to impact itch

• Strong downregulation of fibrosis and Th1/2/17 activation markers

Mechanistically Well

Matched

Important Unmet Medical

Need:

White Space Opportunity

Significant Market Size

and Revenue Potential

Potential for Cost-effective

Clinical Trial Design

• Debilitating symptoms include severe itch, hair loss, sores, fatigue, QoL impacts

• Unsatisfied market; disease management has focused on immunosuppression

and topical symptom control; No FDA-approved therapy

• Despite lack of Tx options, approximately 40% seek medical advice

• Provides estimated peak US revenue potential of $1B to $4B

• Clinical design planned to be phased and multi-part, enabling cost

effective development

• Regulatory pathways may allow for expedited review

Continued Clinical Momentum in 2026 & 2027

Three Clinical Programs Ongoing; IND Expected in 2026

Bosakitug (ATI-045)

Enrollment in Phase 2 in AD

complete

Top line results in 4Q 2026

ATI-052

AD and Asthma POCs

ongoing

Top line POC results in AD

and Asthma in 2H 2026

Phase 2b program:

2H 2026

ATI-2138

Next clinical indication:

Lichen planus

Phase 2b trial to initiate in

2H 2026

Next Generation

Therapeutics

IND for ITK inhibitor

ATI-9494

in 2H 2026

Advancing

potentially

industry-leading

inhibitor franchises

designed to

address validated,

therapeutically-relevant immune

targets

Innovation

Driven

Patient

Focused

29 All future development, clinical, and regulatory timelines are expectations, are based on current beliefs and assumptions, and are subject to change based on a variety of factors

Clinical Pipeline Update:

ATI-052: Full SAD MAD Results

ATI-2138: Potential Mechanistically-Complete Therapy for Lichen Planus

April 28, 2026

EX-99.2

Filename: acrs-20260428xex99d2.htm · Sequence: 3

Exhibit 99.2

Aclaris Therapeutics Announces Positive Full Top Line First-in-Human Results from Phase 1a Healthy

Volunteer Clinical Trial of ATI-052, a Novel Potential First-in-Class Anti-TSLP/IL-4Rα Bispecific

Antibody, and Announces Lichen Planus as Lead Indication for ATI-2138, an Oral ITK/JAK3 Inhibitor

- Positive Full Results from Phase 1a Trial of Anti-TSLP/IL-4Rα 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 -

- Management to Host a Conference Call to Discuss Update Today at 8:30 AM EST -

WAYNE, Pa., April 28, 2026 -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today 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-4Rα bispecific antibody ATI-052 and the selection of lichen planus (LP) as the lead indication for its selective ITK/JAK3 inhibitor ATI-2138.

“These results validate that ATI-052 is a highly potent and well tolerated bispecific antibody that has the potential to be highly effective in a variety of inflammatory and immunological disorders,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “Based on the strong safety and tolerability profile and dose proportional pharmacokinetic and pharmacodynamic profiles that support the potential for an extended dosing schedule of up to every three months and the potential for synergistic efficacy resulting from its dual inhibition of TSLP and IL-4Rα, we are rapidly progressing this molecule through two proof-of-concept studies and plan to initiate a Phase 2b program in the fourth quarter of 2026.”

Continued Dr. Walker, “We also intend to initiate a phased multi-part Phase 2b basket study in lichen planus with ATI-2138 later this year. ATI-2138 is the only known drug that hits pathogenic T cells, the key drivers of interface dermatitis disorders like LP, by inhibiting both TCR and effector cytokine mediated activation - and as such we believe it is an ideal mechanistic fit for this indication. LP causes debilitating symptoms and significant impacts to quality of life across the spectrum of subtypes; there are no therapeutic options approved for use in this disease. We expect our Phase 2b program to initially focus on erosive mucosal and cutaneous LP, starting in the second half of this year, and move into lichen planopilaris shortly thereafter.”

ATI-052: Anti-TSLP/IL-4Rα Bispecific Antibody

Full Top Line Phase 1a SAD/MAD Results

ATI-052 is an investigational anti-TSLP and anti-IL-4Rα bispecific antibody that exhibits high binding affinity to, and dual blockade of, both the TSLP receptor signal transduction and downstream IL-4Rα activation thereby inhibiting this central proinflammatory pathway. By addressing the shared receptor IL-4Rα, ATI-052 blocks IL-4 and IL-13 biological activity, key cytokines driving Th2 inflammation. The Company provided interim results in January 2026 (press release here). Today’s update provides full top line results including:

● ATI-052 exhibited a potential best-in-class pharmacokinetic (PK) profile, including an estimated half-life of approximately 45 days1. 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.

Phase 1a SAD/MAD Trial Design

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.

Ongoing and Future Clinical Trials

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-4Rα, 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: Selective ITK/JAK3 Inhibitor

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.

“Lichen planus remains a challenging, immune-mediated disease with significant patient burden, and there is a clear need for additional therapies that can more effectively address both its symptoms and underlying pathology,” said Dr. Johann Gudjonsson, MD, PhD, Arthur C. Curtis Professor of Skin Molecular Immunology, University of Michigan Skin Research Center.

Webcast and Conference Call

Aclaris will host a webcast and conference call with slides today at 8:30 AM ET to discuss the full ATI-052 Phase 1a SAD/MAD results and an overview of the lead indication and upcoming clinical program for ATI-2138. The live and archived webcast will be available on the Events page of the Company’s website: https://investor.aclaristx.com/events. The webcast will be archived on the same page for 30 days following the event. If you would rather access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. Upon registering you will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details.

About ATI-052

ATI-052 is an investigational humanized anti-TSLP and anti-IL-4Rα 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-4Rα, 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. ATI-052 has the potential to treat a variety of atopic, immunologic and respiratory diseases. Aclaris has the exclusive worldwide rights to ATI-052, excluding Greater China.

About ATI-2138

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). ITK regulates T cell receptor signal transduction and inhibition of this kinase can affect T cell differentiation and activation. JAK3 is a key signal transduction kinase that forms a heterodimer with JAK1, modulates JAK1 phosphorylation of signal transducer and activator of transcription 5 (STAT5), and regulates cytokines that signal through the IL-2Rgc to affect lymphocyte proliferation and activation. The efficacy results exhibited in preclinical animal models of inflammation and autoimmune diseases, coupled with the favorable safety, pharmacokinetics, and pharmacodynamics profile observed in healthy human SAD and MAD studies and a Phase 2a trial in atopic dermatitis, support the potential for ATI-2138 to affect several human inflammatory diseases and further investigation of this molecule in patients with atopic and autoimmune diseases that are dependent on T cell function and/or IL-2Rgc signaling.

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. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.

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 that term is 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 its development plans for ATI-052 and ATI-2138, including the timing to report results from its Phase 1b trials of ATI-052 in asthma and atopic dermatitis, the timing to initiate a Phase 2b trial of ATI-052 in asthma, and the timing and plans to initiate a Phase 2b basket study of ATI-2138 in LP, the therapeutic potential for ATI-052 and ATI-2138, including the potential for ATI-052 to be first- and best-in-class, and the potential for ATI-052 to support dosing of up to three months, and the potential for ATI-052 to treat atopic, immunologic, and respiratory diseases and ATI-2138 to treat atopic and autoimmune diseases. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, risks associated with interim, topline and

preliminary data, 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, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are 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. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. 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, and 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.

1 Based on accumulation ratio at 240 mg weekly dosing

Aclaris Therapeutics Contact:

Will Roberts

Senior Vice President

Corporate Communications and Investor Relations

(484) 329-2125

wroberts@aclaristx.com

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

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Data Type:

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Balance Type:

Period Type:

duration