ACRS

- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Validate Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Timelines Reaffirmed for Upcoming Top Line Results from Phase 1b Proof-of-Concept (POC) Trials of ATI-052 and Phase 2 Trial of Bosakitug (ATI-045) - - Strong Cash Runway Expected to Enable Development of Pipeline Through the End of 2028 - WAYNE, Pa., Aug. 06, 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 its financial results for the second quarter of 2026 and provided a corporate and clinical update. “The first half of 2026 was a period of strong execution across the organization, positioning Aclaris for an exciting second half of the year with numerous expected key catalysts,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “We expect to provide three clinical data readouts, including placebo-controlled top line results from our two Phase 1b POC trials of our anti-TSLP/IL-4Rα bispecific antibody ATI-052 in both asthma and atopic dermatitis and the Phase 2 AD trial of our anti-TSLP monoclonal antibody bosakitug. Other key catalysts include initiation of a Phase 2b clinical program with ATI-052 and a Phase 2b trial in lichen planus with modzatinib. Finally, our data presented recently at the FASEB Immunoreceptors and Immunotherapy conference support the best-in-class potential of our investigational ITK inhibitor ATI-9494, for which we expect to file an IND late this year.” Second Quarter 2026 Highlights, Recent Updates and Upcoming Catalysts Pipeline: Biologics: Antibody Franchise Provided Positive Full Top Line Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 Validating Potency and Potential for Extended Dosing: ATI-052 was well tolerated and demonstrated a favorable safety profile. The combination of the strong and sustained PK duration and PD effect supported the potential for up to quarterly dosing. (press release here) Reaffirmed Expectation of Top Line Results in the Second Half of 2026 from Two Ongoing Phase 1b POC Trials of ATI-052: ATI-052 is being assessed in POC trials in both atopic dermatitis (AD) and asthma. Confirmed Intent to Initiate a Phase 2b Program Encompassing Asthma and AD with ATI-052 in the Fourth Quarter of 2026: Aclaris expects the clinical program to commence with a Phase 2b trial in asthma in the fourth quarter of 2026. The Company also now expects to commence startup activities for a Phase 2b trial in AD and for a proof-of-concept (POC) trial in eosinophilic esophagitis (EoE). On Track for Expected Fourth Quarter 2026 Readout of Top Line Results from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Enrollment is complete in this randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate bosakitug in 109 patients with AD. (press release here) Kinase Inhibitors: ITK Franchise Initiation of Phase 2b Clinical Program for Modzatinib (ATI-2138), a Potent and Selective Investigational Inhibitor of ITK and JAK3, Planned for the Fourth Quarter of 2026: Aclaris intends to initiate a multi-part Phase 2b trial of modzatinib in lichen planus, an unaddressed chronic, inflammatory, CD8-driven interface dermatitis. There are currently no approved therapies in this indication. (press release here) On Track for Expected Fourth Quarter 2026 Filing of Investigational New Drug (IND) Application for ATI-9494, Aclaris’ Investigational Dual Inhibitor of ITK and TXK: ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications. Presented Data Characterizing Potency, Selectivity, and Target Occupancy of ATI-9494: New preclinical data presented at the 2026 Federation of American Societies for Experimental Biology (FASEB) Immunoreceptors and Immunology Science Research Conference included results from cellular target engagement studies that demonstrated potent engagement of ITK by ATI-9494 and its ability to block functional activation of the TCR pathway. ATI-9494 demonstrated potency up to 25 times greater than soquelitinib (CPI-818) across multiple biochemical and functional cellular assays. Financial Results Liquidity and Capital Resources As of June 30, 2026, Aclaris had cash, cash equivalents and marketable securities of $170.6 million compared to $151.4 million as of December 31, 2025. Subsequent to June 30, 2026, the Company sold 7.3 million shares of its common stock for aggregate gross proceeds of $40.2 million, pursuant to the Company’s at-the-market (ATM) agreement with Leerink Partners LLC and Cantor Fitzgerald & Co. Proceeds from these sales provide the Company with additional funds to support the planned commencement of startup activities for the Phase 2b trial of ATI-052 in AD and a POC trial in EoE. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2028, without giving effect to any potential business development transactions or additional financing activities. Second Quarter 2026 and Year-to-Date 2026 Net loss was $21.5 million for the second quarter of 2026 compared to $15.4 million for the second quarter of 2025. Net loss was $41.3 million for the six months ended June 30, 2026 compared to $30.5 million for the six months ended June 30, 2025. Total revenue was $1.6 million for the second quarter of 2026 compared to $1.8 million for the second quarter of 2025. Total revenue was $3.6 million for the six months ended June 30, 2026 compared to $3.2 million for the six months ended June 30, 2025. The increase for the six-month period was primarily driven by higher royalties earned under the Lilly and Sun Pharma license agreements. Research and development (R&D) expenses were $18.1 million and $33.7 million for the quarter and six months ended June 30, 2026, respectively, compared to $11.4 million and $23.0 million for the corresponding prior year periods. The increases were primarily driven by expenses related to ATI-052, including product candidate manufacturing costs and clinical development expenses associated with a Phase 1a program and Phase 1b programs in AD and asthma, as well as product candidate manufacturing costs for ATI-9494. General and administrative (G&A) expenses were $6.0 million and $12.8 million for the quarter and six months ended June 30, 2026, respectively, compared to $5.4 million and $11.5 million for the prior year periods. The increases were primarily due to an increase in professional and legal expenses as well as personnel expenses. Revaluation of contingent consideration resulted in a $0.3 million charge for each of the quarter and six months ended June 30, 2026 compared to charges of $1.5 million and $1.8 million for the prior year periods. The decreases were primarily due to changes to the probability of success for certain product candidates and lower discount rates being applied to potential payments during the quarter and six months ended June 30, 2025. 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 plans for its development programs for bosakitug, ATI-052, modzatinib (ATI-2138), and ATI-9494, including the timing of reporting top line results from its Phase 2 trial of bosakitug in AD and its Phase 1b trials of ATI-052 in asthma and AD, the clinical development plans for ATI-052 including the timing of initiating a Phase 2b trial in asthma, the timing of initiating a Phase 2b trial in lichen planus with modzatinib, the timing to file an IND for ATI-9494, the potential for ATI-052 to have extended dosing, the therapeutic potential of its product candidates and the potential for such candidates to be best-in-class, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations through the end of 2028. 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 preclinical and clinical studies, 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. Aclaris Therapeutics Contacts: Kevin BalthaserChief Financial Officer(484) [email protected] Will RobertsSenior Vice PresidentCorporate Communications and Investor Relations(484) [email protected]

- Full Top Line Results from Phase 1a SAD/MAD Trial of ATI-052 Exceed Aclaris’ Target Profile, Validating Potential Best-in-Class Potency Advantage and Opportunity for Extended Dosing - - Unique Dual Mechanism of ATI-2138 Supports Planned Phase 2b Clinical Trial in Lichen Planus - - Strong Cash Runway Expected to Enable Development of Pipeline Through 2028 - WAYNE, Pa., May 07, 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 its financial results for the first quarter of 2026 and provided a corporate and clinical update. “Since the start of 2026, we have made great progress toward our goal of developing best-in-class compounds to address a variety of immuno-inflammatory diseases,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “Most recently, the positive results from our Phase 1a SAD/MAD trial of our bispecific antibody ATI-052 confirmed its potential as having a best-in-class PK/PD profile with an extended dosing schedule of up to every three months. We look forward to an exciting rest of the year with expected milestones including delivery of placebo-controlled top line results from our Phase 1b proof-of-concept trials of ATI-052 in both asthma and atopic dermatitis and the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in atopic dermatitis.” First Quarter 2026 Highlights and Recent Updates Pipeline: Biologics: Antibody Franchise Provided Positive Full Top Line Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052 Confirming Potency and Potential for Extended Dosing: ATI-052 exhibited a potential best-in-class pharmacokinetic (PK) profile, including an estimated half-life of approximately 45 days. The pharmacodynamic (PD) results validate the potency of ATI-052, including robust target engagement demonstrated by complete and sustained inhibition through at least week 20 of ex vivo TSLP stimulated CCL17 (TARC) and at least week 12 of ex vivo IL-4 stimulated CCL17 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. ATI-052 was well tolerated and demonstrated a favorable safety profile. (press release here) Confirmed Expectation of Top Line Results in the Second Half of 2026 from Two Ongoing Phase 1b Proof-of-Concept (POC) Trials of ATI-052: In January, the Company announced initiation of a POC trial in patients with atopic dermatitis (AD). In February, Aclaris initiated a POC trial in patients with asthma. Dosing is ongoing in both trials, and top line results from both are expected in the second half of 2026. (press releases here and here) Announced Phase 2b Program for ATI-052: Given the data developed to date and its unique mechanism of action, the Company announced its intent to initiate a Phase 2b program with ATI-052, initially targeting asthma, in the fourth quarter of 2026. Completed Enrollment in Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug; Confirmed Expectation of Top Line Results in the Fourth Quarter of 2026: Enrollment is complete in this randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate bosakitug in 109 patients with AD. The Company expects to provide top line results in the fourth quarter of 2026. (press release here) Oral Inhibitors: ITK Franchise Announced Lichen Planus Development Strategy for ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3: Aclaris intends to initiate a phased Phase 2b basket study of ATI-2138 comprising the three most common subtypes of lichen planus (LP), an unaddressed chronic, inflammatory, CD8-driven interface dermatitis: erosive mucosal, cutaneous, and lichen planopilaris, a rare form of LP that causes permanent hair loss. There are currently no approved therapies. 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. (press release here) Presented Additional Phase 2a Results at 2026 American Academy of Dermatology (AAD) Annual Meeting Providing Additional Support for the Therapeutic Potential of ATI-2138: Additional week 12 results included a 70% improvement in the affected percentage of Body Surface Area (BSA) score, a 50% improvement in worst itch intensity as measured by Peak Pruritus Numerical Rating Scale (PP-NRS), a 55% improvement in AD severity over the past week as measured by patient-oriented eczema measure (POEM), and a 65% improvement in quality of life as measured by the Dermatology Life Quality Index (DLQI). (press release here) Confirmed Intent to File Investigational New Drug (IND) Application for Lead ITK Inhibitor ATI-9494 in the Second Half of 2026: Aclaris’ lead preclinical ITK inhibitor candidate ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications. Aclaris intends to file an IND for ATI-9494 in the second half of 2026. Financial Results Liquidity and Capital Resources In March 2026, the Company sold 18.4 million shares of its common stock for aggregate gross proceeds of $59.8 million, pursuant to the Company’s amended and restated sales agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., as sales agents. As of March 31, 2026, Aclaris had cash, cash equivalents and marketable securities of $190.8 million compared to $151.4 million as of December 31, 2025. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2028, without giving effect to any potential business development transactions or financing activities. First quarter 2026 Net loss was $19.8 million for the first quarter of 2026 compared to $15.1 million for the first quarter of 2025. Total revenue was $2.0 million for the first quarter of 2026 compared to $1.5 million for the first quarter of 2025. The increase was primarily driven by higher royalties earned under the Lilly and Sun Pharma license agreements. Research and development (R&D) expenses were $15.7 million for the quarter ended March 31, 2026 compared to $11.6 million for the prior year period. The increase was primarily driven by expenses related to ATI-052, including clinical development expenses associated with a Phase 1a program and Phase 1b programs in AD and asthma, as well as product candidate manufacturing costs for ATI-9494. The increase was partially offset by a reduction in preclinical and clinical development expenses for ATI-2138. General and administrative (G&A) expenses were $6.7 million for the quarter ended March 31, 2026 compared to $6.1 million for the prior year period. The increase was primarily due to an increase in professional and legal expenses as well as personnel expenses. 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 plans for its development programs for bosakitug, ATI-052, ATI-2138 and ATI-9494, including the timing of reporting top line results from its Phase 2 trial of bosakitug in AD and its Phase 1b trials of ATI-052 in asthma and AD, the timing of initiating a Phase 2b program for ATI-052, the timing of initiating a Phase 2b trial in lichen planus with ATI-2138, the timing to file an IND for ATI-9494, the potential for ATI-052 to have extended dosing, the therapeutic potential of its product candidates and the potential for such candidates to be best-in-class, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations through the end of 2028. 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 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. Aclaris Therapeutics Contacts: Kevin Balthaser Chief Financial Officer (484) 329-2178 [email protected] Will Roberts Senior Vice President Corporate Communications and Investor Relations (484) 329-2125 [email protected]

Rigel Pharmaceuticals (RIGL) came out with quarterly earnings of $0.44 per share, missing the Zacks Consensus Estimate of $0.74 per share. This compares to earnings of $0.63 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -40.54%. A quarter ago, it was expected that this drug developer would post earnings of $1.33 per share when it actually produced earnings of $1.14, delivering a surprise of -14.29%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Rigel, which belongs to the Zacks Medical - Drugs industry, posted revenues of $58.82 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 2.39%. This compares to year-ago revenues of $53.33 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Rigel shares have lost about 31% since the beginning of the year versus the S&P 500's gain of 5.2%. While Rigel has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Rigel was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.10 on $70.27 million in revenues for the coming quarter and $4.25 on $285.06 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Drugs is currently in the top 35% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Aclaris Therapeutics (ACRS), is yet to report results for the quarter ended March 2026. This specialty pharmaceutical company is expected to post quarterly loss of $0.16 per share in its upcoming report, which represents a year-over-year change of -33.3%. The consensus EPS estimate for the quarter has been revised 0.6% lower over the last 30 days to the current level. Aclaris Therapeutics' revenues are expected to be $1.37 million, down 6.4% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Rigel Pharmaceuticals, Inc. (RIGL) : Free Stock Analysis Report Aclaris Therapeutics, Inc. (ACRS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

- 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 (GLOBE NEWSWIRE) -- 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: 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-2Rγc 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-2Rγc 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. 1Based on accumulation ratio at 240 mg weekly dosing Aclaris Therapeutics Contact: Will Roberts Senior Vice President Corporate Communications and Investor Relations (484) 329-2125 [email protected] Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6b2f9dba-280e-4444-8055-6f8112b06aa5 https://www.globenewswire.com/NewsRoom/AttachmentNg/fb3bc6d2-b0de-4917-843c-242f7f16a347

- Participants with Atopic Dermatitis Receiving ATI-2138 Experienced Improvements in Key Clinical Measures including Disease Severity, Itch, and Quality of Life - WAYNE, Pa., March 27, 2026 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today provided additional results from its Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of ITK and Janus kinase 3 (JAK3), presented in an electronic poster at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO. “We have continued to achieve important milestones for our potential best-in-class ITK inhibitor franchise, including the presentation of additional positive results from our open-label Phase 2a trial of ATI-2138 at this year’s AAD meeting,” said Dr. Jesse Hall, Chief Medical Officer of Aclaris. “Beyond the previously disclosed efficacy measures, patients receiving ATI-2138 experienced substantial improvements in disease severity, itch, affected percentage of body surface area, and disease-related quality of life measures. In total, these results further validate the strong mechanistic rationale for the use of ATI-2138 in a wide variety of immuno-inflammatory diseases.” 2026 American Academy of Dermatology (AAD) Annual Meeting In an ePoster (74636) entitled, “Results from an Open-Label Phase 2 Trial of ATI-2138, an Investigational Oral Covalent Inhibitor of Interleukin-2-Inducible T Cell Kinase (ITK) And Janus Kinase 3 (JAK3), in Patients with Moderate-To-Severe Atopic Dermatitis (AD),” the Company provided results showing that ATI-2138 was well tolerated and exposure to the compound led to rapid and sustained improvements in clinical signs and symptoms of AD. The ePoster can be accessed here. At end of treatment (week 12), patients receiving a low dose (10 mg BID) of ATI-2138 experienced a 77% improvement in extent and severity of atopic dermatitis (AD) as measured by the Eczema Area and Severity Index (EASI). Additional week 12 results presented at AAD included that patients receiving ATI-2138 experienced: A 70% improvement in the affected percentage of Body Surface Area (BSA) score. A 50% improvement in improvement in Peak Pruritus Numerical Rating Scale (PP-NRS), a validated scale for evaluating worst itch intensity in adults with moderate-to-severe AD. A 55% improvement in patient-oriented eczema measure (POEM), a validated self-assessed measurement tool for tracking severity of AD based on symptoms over the prior week. A 65% improvement in Dermatology Life Quality Index (DLQI), a questionnaire that assesses the impact of skin disease on symptoms and feelings, daily activities, leisure, work and school, personal relationships and the impact of treatment. As previously disclosed, near complete and sustained ITK target occupancy was observed across the dosing interval. The high potency and near complete target occupancy at a very low dose of ATI-2138 potentially enables low drug burden, dosing flexibility, and improved tolerability compared to the JAK class. Results of Tape-Strip analyses show that ATI-2138 modulated Th1, Th2, Th17, fibrotic, and T cell activation/immune signaling pathway markers, supporting the broad therapeutic potential for the compound. About the Phase 2a Trial The Phase 2a trial was an open-label, single-arm study designed to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of 10mg of ATI-2138 administered twice daily (BID) for 12 weeks in patients with moderate-to-severe AD. The primary endpoints were safety-related parameters. Secondary endpoints included pharmacodynamic assessments and efficacy as measured by scoring tools including the Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS), and other pertinent efficacy related measures. 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-2Rγc to affect lymphocyte proliferation and activation. The efficacy results exhibited in preclinical animal models of inflammation and autoimmune diseases, coupled with the favorable safety, PK, and PD profile in healthy human SAD and MAD studies and the top-line results of the Phase 2a trial in AD, 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-2Rγc 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-2138, including plans for its next phase of development, the potential for Aclaris’ ITK franchise to be best-in-class; the mechanistic rationale of ATI-2138 in a variety of immuno-inflammatory diseases; and the potential for ATI-2138 to enable low drug burden, dosing flexibility, and improved tolerability compared to the JAK class. 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, potential changes to interim, topline and preliminary data as more subject data become available, 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. Aclaris Therapeutics Contact: Will Roberts Senior Vice President Corporate Communications and Investor Relations (484) 329-2125 [email protected]

WAYNE, Pa., Feb. 26, 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 its financial results for the fourth quarter and full year ended 2025 and provided a corporate update. “2025 was a year of strong business execution and continued momentum in each of our potential best-in-class programs and positioned us for an exciting 2026 with important milestones and data readouts expected from each program,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “2026 started with derisking events for two of our key programs, ITK and ATI-052; this included compelling ATI-052 interim Phase 1a SAD/MAD results showing strong safety and tolerability profiles, robust target engagement reinforcing the potency of the compound even at very low doses, and the opportunity for extended dosing supported by dose proportional pharmacokinetic and pharmacodynamic profiles. Since then, we have initiated two Phase 1b POC trials with ATI-052, with top line results expected from both trials in the second half of this year. With a strong cash position and several meaningful catalysts across our biologics and ITK pipeline expected this year, including top line results from the Phase 2 trial of our anti-TSLP monoclonal antibody bosakitug in AD, we are looking forward to an exciting and productive year.” Fourth Quarter 2025 Highlights and Recent Updates Pipeline: Biologics: Antibody Franchise Provided Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052; Complete Top Line Results from SAD and MAD Cohorts Expected in the Second Quarter of 2026: ATI-052 was well tolerated and demonstrated a favorable safety profile across all single and multiple ascending dose cohorts in this Phase 1a trial. Interim results included a dose proportional pharmacokinetic (PK) profile and concentration-dependent pharmacodynamics (PD) validating the potency and specificity of the compound, including robust target engagement and near complete target occupancy even at very low doses. These results support the potential for up to every three months dosing. Additional SAD and MAD results from this trial are expected in the second quarter of 2026. (press release here) Announced Initiation of Two Phase 1b Proof-of-Concept (POC) Trials of ATI-052: Following positive interim Phase 1a SAD/MAD results, the Company has initiated Phase 1b POC studies in AD and asthma. Top line results from both trials are expected in the second half of 2026. (press releases here and here) Planning Underway for Phase 2b Program for ATI-052: Planning is ongoing for a Phase 2b program encompassing asthma and AD as potential first indications. The Company expects to initiate this program in the second half of 2026. Confirmed Expectation of Top Line Results in the Second Half of 2026 from Ongoing Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: This randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate bosakitug in approximately 96 patients with moderate-to-severe AD. Oral Inhibitors: ITK Franchise Aclaris’ Lead ITK Inhibitor ATI-9494 Advancing Toward Expected Investigational New Drug (IND) Application in the Second Half of 2026: Aclaris’ lead ITK inhibitor candidate ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications. Aclaris intends to file an IND for ATI-9494 in the second half of 2026. ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, Demonstrated Rapid and Sustained Hair Regrowth in Validated Murine Model of Severe Alopecia Areata (AA), Further Validating Best-in-Class Potential: ATI-2138 and ritlecitinib were assessed compared to control in a reversal model of murine alopecia universalis, the most severe AA phenotype. ATI-2138 demonstrated potential best-in-class results including rapid, near complete, and sustained hair regrowth compared to control and ritlecitinib including mean hair regrowth of 93% for ATI-2138 at week 6 (end of study) compared to 78% for the same dose of ritlecitinib. Mice receiving control showed no improvement in hair regrowth. The Company is completing the assessment of additional indications that are relevant to the dual pharmacology and mechanism of action, including certain alopecias and other inflammatory disorders. (press release here) Financial Results Liquidity and Capital Resources As of December 31, 2025, Aclaris had cash, cash equivalents and marketable securities of $151.4 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations into the second half of 2028, without giving effect to any potential business development transactions or financing activities, or trial execution costs associated with its planned Phase 2b program for ATI-052. Fourth Quarter and Full Year 2025 Net loss was $19.8 million for the fourth quarter of 2025 compared to $96.6 million for the fourth quarter of 2024. Net loss was $64.9 million for the year ended December 31, 2025 compared to $132.1 million for the year ended December 31, 2024. Total revenue was $1.3 million for the fourth quarter of 2025 compared to $9.2 million for the fourth quarter of 2024. The decrease was primarily driven by the achievement of a commercial milestone under the license agreement with Eli Lilly and Company in the fourth quarter of 2024. Total revenue was $7.8 million for the year ended December 31, 2025 compared to $18.7 million for the year ended December 31, 2024. Research and development (R&D) expenses were $16.6 million for the quarter ended December 31, 2025 compared to $9.0 million for the prior year period. The increase was primarily due to higher product candidate manufacturing costs and preclinical and clinical development expenses for bosakitug and ATI-052, and preclinical development expenses for ATI-9494. For the year ended December 31, 2025, R&D expenses were $52.6 million compared to $33.6 million for the year ended December 31, 2024. General and administrative (G&A) expenses were $5.6 million for the quarter ended December 31, 2025 compared to $5.0 million for the prior year period. The increase was primarily due to higher compensation-related expenses and legal expenses. For the year ended December 31, 2025, G&A expenses were $22.0 million compared to $22.2 million for the year ended December 31, 2024. Licensing expenses were $0.9 million for the quarter ended December 31, 2025 compared to $8.6 million for the prior year period. The decrease was primarily due to a milestone achieved during the fourth quarter of 2024, the entirety of which was payable to a third party. For the year ended December 31, 2025, licensing expenses were $5.2 million compared to $12.7 million for the year ended December 31, 2024. Revaluation of contingent consideration resulted in a $0.4 million charge for the quarter ended December 31, 2025 compared to a $1.3 million gain for the prior year period. For the year ended December 31, 2025, revaluation of contingent consideration resulted in a charge of $2.3 million compared to a $2.5 million charge for the year ended December 31, 2024. During the quarter and year ended December 31, 2024, the Company recorded $86.9 million of in-process research and development expenses, representing the fair value of consideration expensed in connection with the in-license of bosakitug (ATI-045) and ATI-052, as well as transaction costs incurred. 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 plans for its development programs for bosakitug, ATI-052, ATI-2138 and ATI-9494, including the timing of reporting complete results from its Phase 1a SAD/MAD trial, results from its Phase 2 trial of bosakitug in AD, and results from its Phase 1b trials of ATI-052 in asthma and AD, the timing of initiating a Phase 2b program for ATI-052 and the timing to file an IND for ATI-9494 and its dosing potential, the potential for ATI-052 to have up to every three-month dosing, the therapeutic potential of its product candidates and the potential for such candidates to be best-in-class, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into the second half of 2028. 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 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. Aclaris Therapeutics Contacts: Kevin Balthaser Chief Financial Officer (484) 329-2178 [email protected] Will Roberts Senior Vice President Corporate Communications and Investor Relations (484) 329-2125 [email protected]

On February 2, BML Capital Management disclosed in a Securities and Exchange Commission filing that it sold out of Alumis (NASDAQ:ALMS), liquidating 1,210,415 shares in an estimated $4.83 million trade. According to a Securities and Exchange Commission (SEC) filing dated February 2, BML Capital Management reported a complete sale of its 1,210,415-share stake in Alumis (NASDAQ:ALMS). As a result, the fund's quarter-end position value in Alumis decreased by $4.83 million, and it now holds no shares. Top holdings after the filing: NASDAQ: ACRS: $42.89 million (38.0% of AUM) NASDAQ: AVIR: $26.74 million (23.7% of AUM) NASDAQ: ORMP: $9.03 million (8.0% of AUM) NASDAQ: TIL: $7.10 million (6.3% of AUM) NASDAQ: PMVP: $6.62 million (5.9% of AUM) As of February 2, shares of Alumis were priced at $26.42, up a staggering 255.1% over the prior year and well outperforming the S&P 500’s roughly 15% gain in the same period. Alumis develops clinical-stage therapies for autoimmune and neuroinflammatory disorders, including ESK-001 and A-005 targeting TYK2 inhibition. The company operates a biopharmaceutical business model focused on advancing proprietary drug candidates through clinical trials toward regulatory approval and commercialization. It targets patients with autoimmune diseases such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative conditions. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory diseases. The company leverages expertise in TYK2 inhibition to advance a pipeline of differentiated drug candidates addressing significant unmet medical needs. With a focus on innovation and clinical rigor, Alumis seeks to establish a competitive position in the biopharmaceutical sector through targeted therapeutic development. BML Capital’s move is a reminder that even disciplined portfolio decisions can collide with fast-moving catalysts. The sale was completed by December 31, as of the filing’s period-end date, before Alumis announced its January upsized public offering and before shares went on to surge roughly 200% in the weeks that followed. At the time, the decision was defensible. Alumis was a clinical-stage biotech with no approved products and heavy R&D spend. As of the third quarter, the company reported $377.7 million in cash and marketable securities, but advancing its TYK2 inhibitor programs toward late-stage trials requires deep pockets and patience. For a fund concentrated in early-stage biotech, risk management might often mean trimming or exiting ahead of known financing events. What changed was the market’s reaction. The January offering removed balance-sheet uncertainty and flipped the narrative from capital risk to clinical optionality. Momentum followed quickly, repricing the stock well ahead of any new trial data. Ultimately, this portfolio remains heavily skewed toward development-stage names, suggesting the exit was about exposure control rather than a negative read on the science. The lesson isn’t necessarily about regret. After all, in biotech, capital events can reset sentiment faster than fundamentals, and sometimes the biggest moves happen after the risk you were managing disappears. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. If you’re worried you’ve already missed your chance to invest, now is the best time to buy before it’s too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you’d have $481,421!* Apple: if you invested $1,000 when we doubled down in 2008, you’d have $51,367!* Netflix: if you invested $1,000 when we doubled down in 2004, you’d have $446,319!* Right now, we’re issuing “Double Down” alerts for three incredible companies, available when you join Stock Advisor, and there may not be another chance like this anytime soon. See the 3 stocks » *Stock Advisor returns as of February 2, 2026 Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Atea Pharmaceuticals. The Motley Fool has a disclosure policy. Alumis Stock Has Rallied 250% This Past Year. One Fund Sold Its $5 Million Stake Last Quarter. was originally published by The Motley Fool

- Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial Reinforce Potential Best-in-Class Potency Advantage of ATI-052 - - Trial Results Support Potential for Extended Dosing of up to Every Three Months - - Initiation of Phase 1b Proof-of-Concept (POC) Trials in Atopic Dermatitis (AD) and Asthma Now Expected in First Quarter of 2026; Planning Underway for Advancement of ATI-052 into Phase 2b Trial in AD in the Second Half of 2026 - - Management to Host a Conference Call to Discuss Update Today at 8:00 AM EST - WAYNE, Pa., Jan. 06, 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 positive interim 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. “Aclaris has experienced significant momentum across our pipeline over the past few months; consistent with that strong momentum, we are pleased to report positive interim results from our Phase 1a SAD/MAD trial of ATI-052 that exceeded our expectations,” said Dr. Neal Walker, Chief Executive Officer of Aclaris. “ATI-052 demonstrated a strong safety and tolerability profile, dose proportional pharmacokinetic profile, and concentration-dependent pharmacodynamics even at the lowest dose – all of which support its best-in-class potential in a variety of inflammatory and immunological diseases due to its ability to uniquely impact multiple pathways of inflammation.” Dr. Walker continued, “These impressive results further validate ATI-052 and reinforce its potential best-in-class potency; given these results, we are rapidly advancing the clinical development of the compound. We expect to initiate Phase 1b proof-of-concept trials in AD and asthma shortly, and planning is already underway for initiation of a Phase 2b trial in AD in the second half of 2026.” Interim Phase 1a SAD/MAD Results The randomized, blinded, placebo-controlled Phase 1a portion of the first-in-human study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered ATI-052 in healthy adults receiving single ascending doses (SAD) and multiple ascending doses (MAD). 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. Interim results of the Phase 1a portion include: ATI-052 was well tolerated and demonstrated a favorable safety profile across all SAD and MAD cohorts, with doses of up to 720 mg. Treatment-emergent adverse events (TEAEs) observed in the trial were predominantly Grade 1. There were no Grade 3 TEAEs related to study drug or serious adverse events; no adverse events led to study discontinuation. The most common TEAE was injection site redness which was self-resolving and generally mild (Grade 1). No conjunctivitis was observed in any cohort. ATI-052 exhibited a potential best-in-class PK profile, including at least a 26-day effective half-life. Dose proportional PK was observed across the pharmacologic dose range, including approximately dose proportional increases in Cmax (maximum peak concentration) and AUC (area under the curve; a measure representing total systemic exposure). PD results from the first three SAD cohorts validate the potency of ATI-052, including robust target engagement and near complete target occupancy at very low doses. Blood samples were collected on days 1, 4, 8, 22, 43, and 113. At the lowest dose tested (30 mg), ATI-052 demonstrated robust concentration-dependent inhibition of IL-4 and TSLP stimulated CCL17/TARC. At 120 mg, ATI-052 demonstrated complete and sustained inhibition of ex vivo IL-4 and TSLP stimulated CCL17/TARC through week one. Near complete inhibition of TSLP stimulated CCL17/TARC was observed at least three weeks after administration. At 360 mg, ATI-052 demonstrated complete and sustained inhibition of ex vivo IL-4 and TSLP stimulated CCL17/TARC through week three. Near complete inhibition of TSLP stimulated CCL17/TARC was observed at least six weeks after administration. The combination of PK duration and the strong and sustained PD effect support the potential for up to every three-month dosing. Imminent Initiation of Phase 1b POC Trials; Phase 2b Planning Underway The positive interim results of the Phase 1a SAD/MAD trial support rapid advancement of clinical development. Aclaris expects to initiate a Phase 1b POC trial in AD imminently and a Phase 1b POC trial in asthma in the first quarter of 2026. The Company expects top line data from both trials in the second half of 2026. Planning is also underway for a Phase 2b trial of ATI-052 in AD expected to initiate in the second half of 2026. Webcast and Conference Call Aclaris will host a webcast and conference call with slides today at 8:00 AM EST to discuss the interim ATI-052 Phase 1a SAD/MAD results. 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 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 X (formerly Twitter) at @AclarisTx and 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, including the timing to initiate and 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 AD, and the therapeutic potential for ATI-052, including the potential to be best-in-class, the potential to show superior activity compared to other therapies, and the potential for dosing of up to three months. 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, potential changes to interim, topline and preliminary data as more subject data become available, 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, 2024, 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. Aclaris Therapeutics Contact: Will Roberts Senior Vice President Corporate Communications and Investor Relations (484) 329-2125 [email protected]