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]

Summary of Aclaris Therapeutics Conference Call Company Overview - **Company**: Aclaris Therapeutics - **Product**: ATI-2138, an investigational compound for moderate to severe atopic dermatitis - **Industry**: Biotechnology, specifically focused on dermatological conditions Key Points Clinical Trial Results - **Phase 2a Trial**: Positive results from the open-label single-arm trial of ATI-2138 in patients with moderate to severe atopic dermatitis [5][12] - **Efficacy**: - At week 12, patients experienced a mean EASI score improvement of 61% and a median improvement of 77% [19] - At week 4, a mean improvement of 71% was observed [20] - 63% of patients achieved a greater than or equal to 4-point improvement in worst itch (PPNRS) at week 12, significantly better than the 43% average seen in other approved drugs [22][23] - **Safety Profile**: - No severe adverse events or treatment-emergent adverse events were reported [17] - Most adverse events were mild and resolved spontaneously [18] - Only one moderate muscle pain was reported, with no significant safety signals observed [19] Mechanism of Action - **Dual Pharmacology**: ATI-2138 is a potent ITK and JAK3 inhibitor, showing 44 times more potency on ITK compared to Ritlacitinib [9][10] - **Target Engagement**: Near-complete ITK target occupancy was observed, indicating strong and persistent inhibition of the enzyme [26] - **Pharmacodynamics**: Significant inhibition of IL-2 and interferon gamma production was noted, supporting the drug's mechanism [25][27] Future Development Plans - **Next Indications**: Alopecia areata is the next target for ATI-2138, with plans for a study expected to start in early 2026 [34][37] - **Next Generation ITK Inhibitors**: Aclaris is developing next-gen ITK inhibitors, with an IND submission anticipated in 2026 [34] - **Cash Position**: The company has a strong cash runway expected to last until 2028, allowing for continued development without dilution [37] Market Positioning - **Atopic Dermatitis**: The trial serves as a proof of concept for ATI-2138, with a focus on its potential in alopecia areata and other Th2-driven diseases [51][56] - **Differentiation**: ATI-2138 is positioned to offer a better safety and tolerability profile compared to traditional JAK inhibitors, which are currently first-line therapies for alopecia areata [56][57] Additional Insights - **Patient Demographics**: The enrolled population was evenly split between males and females, with half identifying as African American [14] - **Compliance Issues**: Some patients faced compliance issues, which affected the per-protocol analysis [13][86] - **Potential for QD Dosing**: There is a possibility for once-daily dosing in future studies, depending on the outcomes of ongoing trials [80] Conclusion - Aclaris Therapeutics has demonstrated promising results for ATI-2138 in treating moderate to severe atopic dermatitis, with a strong safety profile and significant efficacy. The company is well-positioned for future growth with plans to expand into alopecia areata and develop next-generation ITK inhibitors, supported by a solid financial foundation.