PresentationWilliam RobertsSenior VP of Corporate Communications & Investor Relations Good morning, everyone. Good to see everybody here. My name is Will Roberts. I'm the Head of Comms for Aclaris, and I'm thrilled to be the first person to welcome you to our 2025 R&D Day up here in New York. Thanks to everybody in the room. Really appreciate you showing up. It's early. We know it. The weather is not ideal, but it's good to see everybody here. And to the folks attending on the webcast, thank you guys as wel ...

PresentationWilliam RobertsSenior VP of Corporate Communications & Investor Relations Good morning, everyone. Good to see everybody here. My name is Will Roberts. I'm the Head of Comms for Aclaris, and I'm thrilled to be the first person to welcome you to our 2025 R&D Day up here in New York. Thanks to everybody in the room. Really appreciate you showing up. It's early. We know it. The weather is not ideal, but it's good to see everybody here. And to the folks attending on the webcast, thank you guys as wel ...

Aclaris Therapeutics (NasdaqGS:ACRS) 2025 R&D Day October 14, 2025 08:00 AM ET Speaker0Hey, good morning, everyone. Good to see everybody here. My name is Will Roberts. I'm the Head of Comms for Aclaris Therapeutics. I'm thrilled to be the first person to welcome you to our 2025 R&D Day up here in New York. Thanks to everybody in the room. Really appreciate you showing up. It's early, we know it. The weather's not ideal, but it's good to see everybody here. To the folks attending on the webcast, thank you g ...

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Company Overview and Strategy - Aclaris is developing therapeutic franchises to address gaps in important Immune and Inflammatory (I&I) diseases, focusing on patient-driven innovation [1, 8] - The company anticipates having three clinical programs in 2025 and four in 2026, with 2026 being an important year for potential inflection points [11] - Aclaris expects its cash runway to extend into the second half of 2028, supporting its preclinical and clinical development plans [11, 14] Pipeline and Programs - Aclaris's pipeline includes Bosakitug (ATI-045), a monoclonal antibody targeting TSLP, ATI-052, a bispecific antibody targeting both TSLP and IL-4Rα, and ATI-2138, an oral inhibitor of ITK/JAK3 [14] - ATI-2138's Phase 2a open-label trial in Atopic Dermatitis (AD) achieved primary and key secondary endpoints, validating ITK as a therapeutic target; at week 12, 63% of patients experienced a ≥4-point improvement in worst itch [14, 103] - Bosakitug is currently in a two-arm placebo-controlled Phase 2 trial, while ATI-052 is in a Phase 1a/1b SAD MAD program with ongoing dosing [14] - The company is developing next-generation ITK selective inhibitors and bispecific antibodies, with potential for IND submissions starting in 2026 [14, 61] Market Opportunity and Technology - The total addressable market for select Th1, Th2, and Th17-mediated diseases is projected to be in the range of $0 to $70 billion globally from 2028-2034 [16] - Aclaris is leveraging its KINect® Technology Platform to target approximately 60% of the Kinome, with the annual sales of kinase drugs in 2024 at $62.8 billion and a market opportunity of $88.6 billion in 2029 [28, 30] - The global healthcare spending in autoimmune diseases in 2024 was $215 billion, with a global AI disease therapeutics market opportunity of $396 billion by 2030 [38] - Multi-specific antibodies had annual sales of $12.6 billion in 2024, highlighting an opportunity for best-in-class multi-specific antibodies for autoimmune and inflammatory diseases [38]

WAYNE, Pa., Sept. 30, 2025 (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 the Company will host it’s 2025 R&D Day in Midtown, New York on Tuesday, October 14, 2025 at 8:00 AM ET to discuss the Company’s progress in addressing therapeutic gaps in immuno-inflammatory markets. To register, please click here. The event will feature presentations by Acla ...

Group 1 - Aclaris Therapeutics, Inc. (NASDAQ:ACRS) is considered a fundamentally strong penny stock, with Acadian Asset Management LLC increasing its holdings by 25.9% in Q1, acquiring 451,044 shares to reach a total of 2,195,191 shares, representing a 2.03% ownership stake [1][2] - The company is showing potential for future success despite a history of failures, as it announced that new data from its Phase 2a trial of ATI-2138 for atopic dermatitis will be presented at the 2025 EADV Congress in Paris [2][3] - ATI-2138 is a selective oral covalent inhibitor targeting ITK and JAK3, aimed at treating moderate to severe atopic dermatitis, with effectiveness discussed in a session led by Dr. Jessica Beaziz-Tordjman [3][4] Group 2 - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company based in Pennsylvania, focused on developing novel drug candidates for immune-inflammatory diseases, operating through Therapeutics and Contract Research segments [4]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory conditions, utilizing both small and large molecule discovery engines [2][28] - The company has a strong balance sheet with $181 million, providing a cash runway through the second half of 2028 [2][28] Pipeline and Clinical Assets Clinical Stage Assets 1. **ATI-045 (Bosacitab)** - A TSLP monoclonal antibody currently in Phase 2, actively enrolling in studies for atopic dermatitis [2][3] - Proven biology with a strong safety profile, showing 60 times more potency than Tezspire [17][18] - Anticipated to have a long residence time of 400 hours, significantly longer than competitors [19][20] - Open-label study results indicate rapid efficacy, with notable improvements in atopic dermatitis symptoms [21][22] 2. **ATI-2138** - An ITK/JAK3 covalent inhibitor, also in Phase 2, with positive data reported in July [3][4] - Demonstrates sub-nanomolar potency and unique dual pharmacology, showing significant advantages over competitors like ritlecitinib [5][6] - Phase 2A study in atopic dermatitis showed a 70% mean change in EASI score at week four, with a favorable tolerability profile [10][12] - Next steps include exploring alopecia areata as a potential indication [16] 3. **ATI-052** - A TSLP/IL4R bispecific construct currently enrolling in SAD-MAD work, with data expected towards the end of the year [3][4] Discovery Portfolio - Aclaris has a robust discovery portfolio, including an ITK-selective inhibitor targeting Th2 diseases, which are currently dominated by biologics [4][27] - The company is positioned to address a broad array of unmet needs in immuno-inflammatory markets, particularly in atopic dermatitis and respiratory disorders [4][28] Competitive Landscape - Aclaris has conducted extensive preclinical work to compare its assets against existing treatments, demonstrating superior potency and safety profiles [18][19] - The company is aware of the competitive intensity in the market and aims to leverage its unique capabilities to maintain an edge [4][28] Future Outlook - Aclaris plans to initiate IND for next-generation ITK inhibitors in 2026, focusing on engineering out JAK to improve safety profiles [27] - The company has a catalyst calendar for 2026, with multiple data readouts expected across its assets [28] Key Takeaways - Aclaris Therapeutics is well-positioned in the biopharmaceutical industry with a strong pipeline and financial backing - The company's focus on both small and large molecules allows it to tackle a wide range of immuno-inflammatory conditions - Upcoming clinical trials and data readouts in 2026 are critical for the company's growth and market positioning [28]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biopharmaceutical company focused on developing large and small molecule therapeutics with a strong research operation based in St. Louis [2][4] Key Assets and Development Pipeline - Aclaris is currently working on four assets: 1. A TSLP monoclonal antibody for atopic dermatitis, with top-line data expected in 2026 [3] 2. A bispecific antibody (ATI-52) targeting TSLP and IL4R, with readouts expected by the end of 2025 [3][4] 3. An oral ITKJAK3 small molecule inhibitor (2138) for atopic dermatitis, moving into alopecia areata later this year [4] 4. A next-generation ITK program expected to enter IND in 2026 [4] Bispecific Antibody Development - ATI-52 targets both IL-4 and IL-13, aiming for a broader therapeutic response across respiratory and dermatological indications [5][6] - The bispecific is designed for high affinity and long residence time (up to 400 hours) against both targets [7][8] - Preclinical work shows independent saturation of binding sites, enhancing the potential for success [9][10] Clinical Trials and Data - The Phase 1 SAD and MAD trials for ATI-52 are expected to report safety, tolerability, and pharmacokinetics data by the end of the year [13][14] - The ongoing Phase 2a trial for ADI-45 showed a 94% response rate in EASI-75, with significant activity observed even after treatment cessation [21][22] - Aclaris is implementing rigorous patient selection criteria to manage placebo response rates in clinical trials [36][38] Competitive Landscape - Aclaris believes that its TSLP antibody (ADI-45) has a competitive edge over existing therapies due to its potency and long residence time [20][28] - The company is aware of the crowded TSLP space but is confident in the differentiation of its products based on clinical data [19][28] Financial Position and Future Plans - Aclaris has approximately $181 million in cash, expected to last until mid-2028, allowing for the completion of key trials [62] - The company is exploring non-dilutive financing options, including monetizing royalty streams from partnerships [63][64] Long-term Strategy - Aclaris is considering partnerships for its respiratory indications while maintaining a focus on atopic dermatitis as a key area for growth [51][52] - The next-generation ITK compounds are expected to enter clinical trials in 2026, with improved potency and selectivity [59][61] Conclusion - Aclaris Therapeutics is positioned to leverage its innovative pipeline and strong clinical data to capture market opportunities in the biopharmaceutical space, particularly in dermatological and respiratory indications [2][4][62]

Core Insights - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [3] Group 1: Upcoming Events - Aclaris will participate in two healthcare conferences in September 2025 [1] - The first event is a fireside chat at the Cantor Global Healthcare Conference on September 3, 2025, at 1:00 PM EDT [4] - The second event is a corporate presentation at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 9:00 AM EDT [4] Group 2: Webcast Information - Live and archived webcasts of both events will be accessible on Aclaris' website for at least 30 days [2]