WAYNE, Pa., March 20, 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 that an ePoster on the results from its open-label Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), will be available during the 2026 American Academy of Dermatology ...

Core Insights - Aclaris Therapeutics has completed patient enrollment in a Phase 2 trial for bosakitug (ATI-045) targeting moderate-to-severe atopic dermatitis, with top line results expected in Q4 2026 [2][3] Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative treatments for immuno-inflammatory diseases [8] - The company has a robust R&D pipeline aimed at addressing unmet medical needs in patients with conditions lacking satisfactory treatment options [8] Product Details - Bosakitug is a humanized anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody designed to inhibit TSLP, which plays a significant role in inflammatory responses [4] - The drug has demonstrated a strong safety profile and efficacy in previous trials, with 94% of participants achieving EASI-75 scores and 88% showing clear or nearly clear skin [4] Clinical Trial Information - The Phase 2 trial involves 109 patients and will assess primary and secondary efficacy endpoints, including changes in the Eczema Area and Severity Index (EASI) and safety measures [3] - The trial's primary endpoint is the percent change from baseline in EASI at week 24, with secondary endpoints including various response measures and pharmacokinetic assessments [3] Disease Context - Atopic dermatitis (AD) affects approximately 10 million children and 17 million adults in the U.S., with over 200 million people affected globally [6] - The condition significantly impacts quality of life, with a notable prevalence of moderate to severe symptoms among affected individuals [6] Mechanism of Action - TSLP is a key regulator of the Type 2 immune response and is involved in various allergic and inflammatory diseases, making it a relevant therapeutic target [5]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biotech company focused on large and small molecule therapeutics in the immunology and inflammation (I&I) space. The company has three clinical stage assets and one asset nearing the clinic with an Investigational New Drug (IND) application expected by the end of the year [6][7]. Clinical Assets - **Large Molecule Therapeutics**: - **ATI-045**: A TSLP monoclonal antibody currently in a Phase 2 study for moderate to severe atopic dermatitis (AD), with data readout expected at the end of the year. The Phase 2A data showed a 94% EASI response and 88% of subjects achieving IGA 0/1 [15][16]. - **ATI-052**: A bispecific construct combining ATI-045 with IL-4R, currently in SAD/MAD work and moving towards Phase 1b studies in moderate asthma and severe AD [6][7]. - **Oral Small Molecule**: - **ATI-2138**: Currently selecting a lead indication with a full Phase 2 ready package. The next-generation ITK is expected to file for IND by the end of the year [6][7]. Key Differentiators - **TSLP Antibody**: - Retention time of over 400 hours compared to competitors like tezepelumab, which has a retention time of about 20 hours. This longer retention translates into higher potency [14][15]. - The antibody has a half-life of 23 days, allowing for potential dosing intervals of up to three months [17][18]. Competitive Landscape - The company aims to position its TSLP antibody as a safe and effective alternative to Dupixent, which targets IL-13. Aclaris believes that TSLP's mechanism of action could provide a complementary treatment option for patients [31][32]. Enrollment and Study Design - Enrollment for the Phase 2B study is on track, with data expected by the end of the year. The study design includes stringent patient screening to minimize placebo variability [27][28][29]. Financial Outlook - Aclaris has sufficient cash runway into Q4 2028, allowing for the continuation of its current programs and the initiation of the Phase 2B asthma study for the bispecific construct [86]. Future Directions - The company is considering various indications for its ITK inhibitors, including atopic dermatitis, asthma, and potentially COPD. The decision on which indication to advance will be made soon [62][63][77]. - Aclaris is focused on optimizing its portfolio of ITK inhibitors, with plans to file an IND for ATI-9494 in the second half of the year [70][71]. Conclusion - Aclaris Therapeutics is actively advancing its clinical pipeline with a focus on innovative therapies for immunological conditions. The company is well-positioned to capitalize on its differentiated assets and has a clear strategy for navigating the competitive landscape in the biotech sector [6][31][86].

Core Insights - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [3] - The company will participate in a fireside chat at the Leerink Partners 2026 Global Healthcare Conference on March 10, 2026 [1] - A live and archived webcast of the event will be available on Aclaris' website for at least 30 days [2] Company Overview - Aclaris Therapeutics is developing a pipeline of product candidates aimed at addressing the needs of patients with immuno-inflammatory diseases who currently lack satisfactory treatment options [3] - The company boasts a multi-stage portfolio of product candidates supported by a robust research and development engine [3]

Drug Development and Clinical Trials - The company is focused on developing novel small and large molecule product candidates for immuno-inflammatory diseases using its proprietary KINect drug discovery platform[16]. - Bosakitug (ATI-045) demonstrated a 94% improvement in Eczema Area and Severity Index (EASI) for at least 75% of patients in a Phase 2a trial, with 65% achieving EASI-90[23]. - ATI-2138 showed a mean improvement of 61% in EASI score at week 12 in a Phase 2a trial, with 63% of patients experiencing a clinically meaningful response[27]. - ATI-052 achieved complete and sustained inhibition of TSLP stimulated CCL17/TARC at least six weeks after administration in a Phase 1a study, with an effective half-life of at least 26 days[31]. - The company plans to initiate a Phase 2b program for ATI-052 targeting asthma and atopic dermatitis in the second half of 2026[32]. - ATI-9494, an investigational oral covalent ITK inhibitor, is expected to file an IND application in the second half of 2026[33]. - The company is exploring ATI-2138 for additional indications relevant to its dual pharmacology, including certain alopecias and other inflammatory disorders[28]. - The company is developing targeted protein degraders to selectively remove difficult-to-drug proteins, including kinases, which may enhance therapeutic efficacy[41]. - Lepzacitinib, an investigational topical "soft" JAK 1/3 inhibitor, is being developed for atopic dermatitis with a focus on low systemic exposure[44]. - The company is exploring multi-specific antibodies to improve target affinity and efficacy, including bispecific antibodies targeting TSLP and other cytokine pathways[42]. - Clinical trials can be suspended by the FDA or IRB if there are unacceptable health risks to participants[78]. - The process for drug approval includes preclinical testing, submission of an IND, and clinical trials in three phases, with Phase 3 trials providing substantial evidence of efficacy[73][74]. - The FDA may issue a Complete Response Letter if an NDA or BLA is not ready for approval, requiring additional data or trials[85]. - Changes to approved products, such as new indications or manufacturing changes, require further FDA review and approval[86]. - The risk of failure for product candidates is high, with extensive clinical trials required to demonstrate safety and efficacy before obtaining regulatory approval[174]. - Clinical trials may produce negative or inconclusive results, leading to potential abandonment of drug development programs[180]. - Delays in clinical trials can significantly increase drug development costs and harm commercial prospects[182]. - Subject enrollment for clinical trials is becoming increasingly difficult and expensive, impacting the ability to complete trials on time[184]. - Adverse side effects or unfavorable safety findings during clinical trials could necessitate the abandonment or limitation of product candidate development[190]. - Interim, topline, and preliminary data from clinical trials are subject to change and should be viewed with caution until final data are available[196]. - Regulatory authorities may require additional warnings or impose restrictions on marketing approvals based on safety findings[194]. - Changes in product candidate manufacturing or formulation may lead to additional costs or delays in clinical trials[199]. - The acceptance of data from clinical studies conducted outside the United States by regulatory authorities like the FDA is uncertain, which could necessitate additional costly studies[200][201]. - Political tensions and economic instability outside the U.S. could disrupt clinical studies, leading to costly delays[202]. Financial Performance and Funding - The company incurred net losses of $64.9 million and $132.1 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $967.8 million as of December 31, 2025[142]. - The company expects to continue incurring significant expenses and operating losses in the near term as it focuses on the development of its product candidates[143]. - The company may need substantial additional funding to meet its financial obligations and pursue its business objectives[143]. - The company has devoted substantially all of its financial resources to the development of its product candidates, including preclinical studies and clinical trials[143]. - Future capital requirements will depend on the number of product candidates pursued and the costs associated with preclinical and clinical studies[152]. - The company may face challenges in raising additional capital, which could impact its ability to continue operations and implement its long-term business strategy[153]. - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $151.4 million, expected to fund operations for over 12 months[151]. - The company acknowledges that market opportunity estimates may prove smaller than anticipated, affecting potential revenue[157]. - The company may need to relinquish rights to technologies or revenue streams if it raises funds through partnerships or licensing agreements[155]. - The company faces unique risks associated with biologics, including complex regulatory requirements and manufacturing challenges[160]. Market and Competitive Landscape - The kinase inhibitors market was valued at over $67 billion in 2025 and is expected to grow to over $94 billion by 2030, highlighting the potential for the company's drug candidates[17]. - The company faces competition from major pharmaceutical companies and biotechnology firms, including Amgen and AstraZeneca, in the monoclonal antibody space[47]. - The company faces substantial competition from larger pharmaceutical and biotechnology firms, which may have greater resources and expertise[211]. - Market acceptance of approved product candidates is crucial for revenue generation, influenced by factors such as efficacy, safety, and pricing[205][207]. - Coverage and adequate reimbursement from third-party payors are critical for the commercial success of approved products[213][214]. - Changes in reimbursement policies and methodologies by third-party payors could impact demand for the company's product candidates[215]. Regulatory Environment - The FDA requires substantial time and resources for regulatory approvals, which can lead to administrative or judicial sanctions if compliance is not maintained[68]. - The FDA has a 60-day review period for NDAs and BLAs to ensure completeness before substantive review begins[81]. - Priority review can shorten the FDA's action time on NDAs and BLAs from ten months to six months for significant treatment improvements[85]. - Non-patent marketing exclusivity for new chemical entities (NCEs) lasts five years, preventing the FDA from accepting ANDAs during this period[93]. - The FDA may require a risk evaluation and mitigation strategy (REMS) for certain products, which can increase approval costs[82]. - The FDCA provides three years of marketing exclusivity for an NDA if new clinical investigations are deemed essential for approval[94]. - Under the BPCIA, a biosimilar application cannot be submitted until four years after the reference product's first FDA license, with a 12-year exclusivity period before approval can be effective[96]. - A biological product can obtain an additional six months of pediatric market exclusivity if a pediatric study is completed as per FDA request[98]. - In the EEA, new chemical entities (NCEs) receive eight years of data exclusivity and an additional two years of market exclusivity upon receiving marketing authorization[101]. - The Community MA issued by the European Commission allows for a maximum evaluation timeframe of 210 days for marketing authorization applications[103]. - The Anti-Kickback Statute prohibits remuneration intended to induce referrals for federal health care programs, with strict legal interpretations[104]. - The civil monetary penalties statute imposes penalties for presenting false claims to federal health programs, including Medicare and Medicaid[109]. Intellectual Property and Partnerships - The company has a patent portfolio for its TSLP monoclonal antibody program, with U.S. patents expiring in 2043 and pending applications potentially expiring in 2040[56]. - The company is committed to protecting its intellectual property through various means, including patent applications and confidentiality agreements[61]. - The company has entered into an exclusive license agreement with Biosion, involving $30 million in upfront cash and potential milestone payments totaling up to $920 million[65]. - The company is actively seeking global development and commercialization partners for its investigational products, excluding Greater China[44]. - The company relies on third parties for manufacturing preclinical and clinical supplies, as it does not have its own manufacturing facilities[45]. - The company relies on third-party partners for commercialization, and their success is contingent on achieving acceptance from the medical community and patients[176].

分组1 - Aclaris Therapeutics reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.15, and compared to a loss of $0.10 per share a year ago, indicating an earnings surprise of -9.59% [1] - The company posted revenues of $1.3 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 33.04%, and a significant decline from year-ago revenues of $9.21 million [2] - Aclaris shares have increased by about 10% since the beginning of the year, outperforming the S&P 500's gain of 1.5% [3] 分组2 - The earnings outlook for Aclaris is mixed, with the current consensus EPS estimate for the coming quarter at -$0.14 on revenues of $2.23 million, and for the current fiscal year at -$0.55 on revenues of $7.18 million [7] - The Medical - Drugs industry, to which Aclaris belongs, is currently ranked in the bottom 44% of over 250 Zacks industries, which may negatively impact stock performance [8] - Zevra Therapeutics, another company in the same industry, is expected to report a quarterly earnings of $0.05 per share, reflecting a year-over-year change of +107.5%, with revenues expected to be $27.91 million, up 132.6% from the year-ago quarter [9]

Aclaris Therapeutics FY Conference Summary Company Overview - Aclaris Therapeutics is a clinical-stage biotech company focused on discovering and developing therapeutics for inflammatory and immunological conditions. The leadership team has extensive experience in drug development from companies like MedImmune, AZ, Centocor, J&J, GSK, and Pfizer [2][4]. Clinical Pipeline - Aclaris has three clinical-stage programs, including: - **Bosakitug**: An anti-TSLP monoclonal antibody completing a Phase II study in atopic dermatitis (AD) in 2026 [2][4]. - **ATI-052**: A bispecific antibody targeting TSLP and IL-4, with ongoing Phase I studies [3][12]. - **ATI-2138**: A potent ITK inhibitor combined with JAK3, with plans for further clinical trials [3][48]. Key Data and Results - **Bosakitug**: - Demonstrated a 90% EASI-75 response in a proof-of-concept study and over 80% responders in IJ01 [6]. - Retention time of 400 hours, significantly longer than competitors like tezepelumab [5][6]. - Expected to show top-line results by the end of 2026 [10]. - **ATI-052**: - Phase I study showed a 26-day half-life, three times longer than dupilumab [18]. - Demonstrated four times more potency than the combination of Tezspire and dupilumab in inhibiting TSLP IL-4-activated PBMC populations [19]. - Safety profile was favorable, with no significant adverse events reported [20]. - **ATI-2138**: - Focused on indications with less competition from existing JAK inhibitors, such as alopecia [46][47]. - Preclinical data showed promising results in severe models of alopecia [47]. Future Plans and Expectations - Aclaris plans to submit an IND for ATI-9494 by the end of the year [48]. - The company is optimistic about the potential of its programs, with data expected in the second half of the year for both bosakitug and ATI-052 [34][38]. - The company aims to explore additional indications for its therapies based on the outcomes of ongoing studies [11][42]. Market Position and Competitive Landscape - Aclaris believes its therapies could offer advantages over existing treatments like dupilumab, particularly in dosing frequency and targeting broader patient populations [38][39]. - The company is positioning itself to capitalize on the growing market for treatments in atopic dermatitis and asthma, with a focus on both T2 high and T2 low patient populations [26][39]. Conclusion - Aclaris Therapeutics is poised for significant developments in 2026, with multiple clinical trials underway and promising data expected. The company is strategically targeting unmet medical needs in the inflammatory and immunological space, with a strong emphasis on safety and efficacy in its drug development efforts [4][51].

Financial Performance - Aclaris reported a net loss of $19.8 million for Q4 2025, a significant decrease from a net loss of $96.6 million in Q4 2024, and a total net loss of $64.9 million for the full year 2025 compared to $132.1 million in 2024[6][18]. - Total revenue for Q4 2025 was $1.3 million, down from $9.2 million in Q4 2024, with full-year revenue of $7.8 million compared to $18.7 million in 2024, primarily due to a commercial milestone achieved in Q4 2024[8][18]. - Net loss improved from $(132,065) thousand in 2024 to $(64,923) thousand in 2025, representing a reduction of about 51%[22]. - Net cash used in operating activities increased from $(20,075) thousand in 2024 to $(47,113) thousand in 2025, indicating a worsening cash flow situation[22]. - Total assets decreased from $220,327 million in 2024 to $160,460 million in 2025, a decline of approximately 27%[20]. - Total stockholders' equity decreased from $155,554 million in 2024 to $103,082 million in 2025, a decline of approximately 34%[20]. - Common stock outstanding increased from 107,850,124 shares in 2024 to 120,499,433 shares in 2025, reflecting an increase of about 12%[20]. - Depreciation and amortization expenses decreased from $807 thousand in 2024 to $454 thousand in 2025, a reduction of approximately 44%[22]. - Stock-based compensation expense rose from $10,856 thousand in 2024 to $12,384 thousand in 2025, an increase of about 14%[22]. - Changes in operating assets and liabilities improved from $10,922 thousand in 2024 to $2,672 thousand in 2025, indicating a positive shift[22]. - Revaluation of contingent consideration decreased slightly from $2,500 thousand in 2024 to $2,300 thousand in 2025[22]. - In-process research and development expense was significantly reduced from $86,905 thousand in 2024 to $0 in 2025, indicating a strategic shift in R&D spending[22]. Cash and Funding - Aclaris had cash, cash equivalents, and marketable securities of $151.4 million as of December 31, 2025, down from $203.9 million in 2024, which is expected to fund operations into the second half of 2028[5][16]. Research and Development - Positive interim results from the Phase 1a SAD/MAD trial of ATI-052 showed a favorable safety profile and robust target engagement, with complete top-line results expected in Q2 2026[1][3]. - Two Phase 1b proof-of-concept trials for ATI-052 in atopic dermatitis and asthma have been initiated, with top-line results anticipated in the second half of 2026[2][7]. - Aclaris plans to file an Investigational New Drug (IND) application for its lead ITK inhibitor candidate, ATI-9494, in the second half of 2026[1][7]. - The company is planning a Phase 2b program for ATI-052, expected to initiate in the second half of 2026, targeting asthma and atopic dermatitis as potential first indications[7][8]. Product Development - ATI-2138 demonstrated a mean hair regrowth of 93% in a murine model of severe alopecia areata at week 6, compared to 78% for ritlecitinib, indicating its potential as a best-in-class treatment[7][8]. Expenses - Research and development expenses increased to $16.6 million for Q4 2025, compared to $9.0 million in Q4 2024, driven by higher costs associated with product candidate manufacturing and clinical development[9][18]. - General and administrative expenses were $5.6 million for Q4 2025, slightly up from $5.0 million in Q4 2024, with full-year G&A expenses totaling $22.0 million compared to $22.2 million in 2024[10][18].

Core Insights - Aclaris Therapeutics reported positive interim results from its Phase 1a trials for the bispecific antibody ATI-052, indicating strong safety and tolerability, with complete results expected in Q2 2026 [1][3] - The company has initiated Phase 1b proof-of-concept trials for ATI-052 in atopic dermatitis and asthma, with top line results anticipated in the second half of 2026 [1][2] - Aclaris plans to file an Investigational New Drug (IND) application for its lead ITK inhibitor candidate, ATI-9494, in the second half of 2026 [1][12] Pipeline Developments - Positive interim results from the Phase 1a SAD/MAD trial of ATI-052 showed a favorable safety profile and robust target engagement, supporting potential extended dosing every three months [3][2] - Two Phase 1b POC trials for ATI-052 have been initiated, with results expected in the latter half of 2026 [3][2] - Planning for a Phase 2b program for ATI-052 is underway, targeting asthma and atopic dermatitis as initial indications [3] Financial Performance - Aclaris reported a net loss of $19.8 million for Q4 2025, a significant decrease from a net loss of $96.6 million in Q4 2024 [7] - Total revenue for Q4 2025 was $1.3 million, down from $9.2 million in Q4 2024, primarily due to a prior commercial milestone [8] - Research and development expenses increased to $16.6 million in Q4 2025 from $9.0 million in the prior year, driven by higher costs associated with product candidate development [9] Liquidity and Capital Resources - As of December 31, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $151.4 million, down from $203.9 million in 2024 [6][20] - The company believes its current financial resources will be sufficient to fund operations into the second half of 2028 [6]

Core Insights - Aclaris Therapeutics has initiated a Phase 1b proof-of-concept trial for ATI-052, a bispecific anti-TSLP/IL-4Rα antibody, targeting asthma, following a similar trial for atopic dermatitis [1][2] - The company plans to start a Phase 2b program for both asthma and atopic dermatitis in the second half of 2026 [1][2] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [5] - The company has a robust R&D engine and a multi-stage portfolio aimed at addressing unmet medical needs in patients with immuno-inflammatory diseases [5] Product Details - ATI-052 is designed to inhibit both thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4Rα), potentially offering a best-in-class treatment option for various atopic, immunologic, and respiratory diseases [4] - The antibody exhibits high affinity and potency, with engineered properties to extend its half-life, enhancing its therapeutic potential [4] Clinical Trial Information - The Phase 1b trial for asthma will be randomized, double-blind, and placebo-controlled, involving approximately 16 patients with asthma [2] - Key endpoints for the trial include safety, tolerability, pharmacokinetics, and efficacy measures such as FEV1 [2]