Aclaris Therapeutics FY Conference Summary Company Overview - Aclaris Therapeutics is a development-stage biotech company focused on large and small molecule therapeutics, leveraging expertise from large pharma and a robust discovery platform [2][3] Pipeline and Clinical Assets - Aclaris has three clinical-stage assets: - **O52**: An IL-4 and TSLP bispecific antibody currently undergoing SAD/MAD studies - **TSLP mAb**: Targeting moderate-to-severe atopic dermatitis, with results expected next year - **2138**: An ITK JAK3 oral inhibitor, with a lead indication expected to start next year [2][3] - By 2026, Aclaris anticipates having four clinical-stage assets, with a cash runway extending into Q3 2028, holding $167 million on the balance sheet [3] Financial Management - The company maintains a modest cash burn of approximately $10 million to $13 million per quarter, allowing for efficient management of multiple programs [4] TSLP mAb Program - The TSLP mAb is positioned to address multi-billion-dollar markets, particularly in atopic dermatitis, with expectations of best-in-class potency [4][5] - Aclaris claims their TSLP mAb is 70 times more potent than Tezspire, with a focus on improving residence time and binding efficacy in the skin [8][10] Clinical Trial Design and Strategy - Aclaris is implementing central photography and adjudication to minimize placebo effects in clinical trials, ensuring accurate patient enrollment [13][15] - The company is open to including patients who have previously failed treatments like Dupixent, as TSLP operates through a different mechanism [21] Upcoming Data and Expectations - Significant data from the TSLP mAb program is expected in the second half of 2026, with a focus on responder rates and efficacy measures [24][41] - The bispecific TSLP-IL-4 program is currently in phase one SAD-MAD studies, with early data anticipated next year [30][36] New Indications and Market Strategy - Aclaris is pursuing lichen planus as a lead indication for their ITK program, targeting a market with less competitive intensity and a prevalence of 2% [45][46] - The company plans to initiate a phase two trial with a placebo control, enrolling approximately 70-80 patients [47] JAK-Sparing ITK Development - Aclaris is developing a JAK-sparing ITK molecule, aiming for IND submission by the end of 2026, targeting both respiratory and dermatological indications [57][59] Multi-Specific Antibody Platform - The company is exploring multi-specific antibodies using TSLP as a backbone, with plans to disclose more information as development progresses [62][64] Conclusion - Aclaris Therapeutics is positioned for significant growth with multiple clinical assets and a strong financial foundation, with 2026 expected to be a pivotal year for data releases and potential market entries [66]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biotech company with three assets in the clinic and another in development, supported by a robust R&D group focused on both new asset discovery and preclinical sciences [1][2] - The company has expertise in kinase inhibition, with a history stemming from Pfizer, and has expanded its portfolio through acquisitions, including a deal with BioShen [2][3] Key Assets and Pipeline - Aclaris is developing both small and large molecule platforms targeting important unmet medical needs [1][2] - The acquisition of BioShen's assets has allowed Aclaris to explore both dermatological and immunological indications, particularly in respiratory and gastrointestinal areas [3] Bosakitug (TSLP Antibody) - Bosakitug is a TSLP antibody in phase two trials, noted for its potency, being 70 times more potent than Tezopelumab [5][9] - It has a long residence time of 400 hours on TSLP compared to 3-20 hours for competitors, which enhances its therapeutic potential [7] - Phase 2A results showed a 94% EASI75 response and an 88% IGA01 response in atopic dermatitis, with sustained effects observed 12 weeks post-treatment [8][12] Phase 2B Study - Aclaris is confident in the phase 2B study due to the robust data from phase 2A, focusing on a well-defined patient population to minimize placebo effects [11][12] - The dosing regimen remains consistent with phase 2A, aiming for a competitive response rate compared to existing treatments [15] Future Directions - Aclaris plans to explore the potential of Bosakitug in both dermatological and respiratory indications, with a focus on dermatology for the current asset [19] - The company is also developing a bispecific antibody (052) targeting TSLP and IL-4R, which has shown promising preclinical results [20][21] ITK Platform and 2138 - 2138 is the lead compound in Aclaris's ITK franchise, demonstrating dual pharmacology by inhibiting ITK and JAK3, with a focus on atopic dermatitis and potential expansion into lichen planus [31][36] - The compound has shown significant potency and a favorable safety profile, with plans to move into clinical trials for lichen planus due to its mechanistic fit and unmet medical need [36][38] Financial Position and Future Outlook - Aclaris has a strong cash position that extends its runway into the second half of 2028, allowing for continued development of its pipeline without immediate capital raises [42] - The company anticipates multiple data readouts and milestones in 2026, which could significantly impact investor interest and market positioning [41][42] Conclusion - Aclaris Therapeutics is positioned for significant growth with a diverse pipeline targeting critical areas in dermatology and immunology, backed by a solid financial foundation and promising clinical data [41][42]

Aclaris Therapeutics FY Conference Summary Company Overview - Aclaris Therapeutics is a development-stage biotech company focused on large and small molecule therapeutics for immunoinflammatory diseases [3][4] - The company has a strong drug discovery platform developed by former Pfizer employees and a multidisciplinary team experienced in drug development [3] Key Products and Pipeline - **2138**: An oral ITK JAK3 inhibitor, currently in clinical development for atopic dermatitis (AD) [3][6] - **TSLP MAB and TSLP IL4R bispecific construct**: In-licensed biologics from BiOcean, currently in clinical trials [3][4][5] - Aclaris is focusing on atopic dermatitis due to the mechanism of action and competitive landscape [6][7] Clinical Development and Data - The company is actively enrolling patients for the TSLP MAB study in atopic dermatitis, with data expected in the second half of 2026 [7][8] - Aclaris believes their TSLP MAB is 70 times more potent than competitors like Tezspire, which enhances their confidence in achieving positive outcomes [9][10] - Previous studies showed high efficacy with EASI 75 scores of 94% and 88% on IgA, indicating strong potential for their treatments [10] Market Position and Strategy - Aclaris is strategically targeting less competitive indications like atopic dermatitis, while also considering high unmet need areas such as lichen planus and scarring alopecia [14][15] - The company is aware of the competitive intensity in the respiratory indications and has opted to focus on atopic dermatitis for their TSLP MAB [6][7] Future Catalysts - Key upcoming milestones include: - Reporting SAD and MAD data by the end of 2026 - Initiating two Phase 1B studies in moderate to severe asthma and atopic dermatitis [52] - Advancing next-gen ITK into the clinic in the second half of 2026 [52] - The company has a strong cash position of over $167 million, providing a runway until Q3 of 2028 [57] Competitive Landscape - Aclaris acknowledges competition in the ITK space but believes their product's potency and broader applicability will differentiate them [25][30] - The company is monitoring competitor data closely and remains optimistic about their own development trajectory [25][30] Challenges and Considerations - The rising placebo rates in clinical trials pose a challenge, with Aclaris emphasizing the importance of rigorous patient selection to ensure valid results [41][42] - The company is aware of the complexities in dermatology trials and is implementing measures to mitigate variability in patient responses [40][41] Conclusion - Aclaris Therapeutics is positioned for a busy and potentially transformative 2026, with multiple catalysts on the horizon and a focus on innovative treatments for immunoinflammatory diseases [58][59]