Financial Data and Key Metrics Changes - The company has a strong balance sheet with over $190 million in cash, providing a runway through the first half of 2028 [4][22] - The company has extended its cash runway by a quarter and a half since the transaction with Biogen [6] Business Line Data and Key Metrics Changes - The company has three assets in clinical development: ATI-2138, ATI-45, and ATI-52, with ongoing studies in various indications [3][4] - ATI-45 is in phase three clinical studies in China for severe asthma and CRS with NP, and phase two studies in COPD [4] - A global phase two study in atopic dermatitis has been initiated, with sites in the US, Canada, and Europe [5][14] Market Data and Key Metrics Changes - The pipeline includes highly differentiated large and small molecule assets targeting multibillion-dollar addressable markets [4] - The company is actively seeking partners for ATI-45 in respiratory indications outside of China [14][15] Company Strategy and Development Direction - The company focuses on developing best-in-class therapeutics with a strong emphasis on both large and small molecule drug development [3] - Future plans include reporting top-line data from various studies in 2026, including those for ATI-2138 and ATI-45 [6][7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical progress and the potential of their pipeline, highlighting a rich catalyst calendar expected in 2026 [6][22] - The company aims to demonstrate the unique pharmacology and safety profile of its assets, particularly in atopic dermatitis and alopecia areata [20][21] Other Important Information - The company has made significant progress in clinical and preclinical plans since the transaction with Biogen [6] - The IND for the bispecific antibody ATI-52 was recently allowed, and phase one SADMAD work has begun [5][17] Q&A Session Summary Question: What are the next steps for the clinical studies? - The company plans to report top-line data from the phase two study of ATI-2138 imminently and initiate a clinical study in alopecia areata [6][20] Question: How does ATI-45 compare to competitors? - Management highlighted that ATI-45 has demonstrated enhanced potency compared to competitors like tezepelumab, with a greater than 60x inhibition of CCL 17 production [9][12] Question: What is the timeline for the next gen ITK selective molecule? - The company plans to file an IND for the next gen ITK molecule in 2026 and begin phase one work shortly thereafter [21][22]

Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [5] - The company has a multi-stage portfolio powered by a robust R&D engine to address the needs of patients lacking satisfactory treatment options [5] Index Inclusion - Aclaris Therapeutics has been added to the Russell 3000 and Russell 2000 Indexes as of June 30, 2025, following the annual reconstitution of the Russell US Indexes [1] - Membership in the Russell 3000 Index, which includes the 4,000 largest US stocks ranked by market capitalization, ensures automatic inclusion in either the large-cap Russell 1000 Index or small-cap Russell 2000 Index [2] Market Impact - The Russell indexes are widely utilized by investment managers and institutional investors for index funds and as benchmarks for active investment strategies [3] - As of June 2024, approximately $10.6 trillion in assets are benchmarked against the Russell US indexes, indicating significant market influence [3]

Core Insights - Aclaris Therapeutics, Inc. will present at the H.C. Wainwright Inflammation & Immunology Virtual Conference on June 30, 2025, at 11:30 AM EDT [1] - A live and archived webcast of the presentation will be available on the Aclaris website for at least 30 days [2] - Aclaris is focused on developing novel product candidates for immuno-inflammatory diseases, addressing unmet patient needs [3] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company with a robust R&D engine and a multi-stage portfolio of product candidates [3] - The company aims to provide treatment options for patients with immuno-inflammatory diseases who currently lack satisfactory therapies [3]

Core Insights - Aclaris Therapeutics has initiated a Phase 1a/1b clinical program for ATI-052, a bispecific antibody targeting TSLP and IL-4R, which is expected to be a best-in-class treatment for immuno-inflammatory diseases [1][2] Group 1: Clinical Development - The Phase 1a program will include single and multiple ascending dose (SAD/MAD) studies in healthy volunteers, followed by a Phase 1b proof of concept assessment in up to two undisclosed indications [2] - Completion of the Phase 1a SAD/MAD portion is anticipated by the end of 2025, with top line results expected in early 2026, and Phase 1b results in the second half of 2026 [2] Group 2: Mechanism of Action - ATI-052 is designed to exhibit high binding affinity and dual blockade of TSLP and IL-4R, inhibiting key proinflammatory pathways involved in Th2-mediated inflammation and allergic diseases [2][4] - The bispecific antibody's dual binding capability may enhance efficacy compared to traditional monoclonal antibodies, with potential applications for various immune-modulated diseases [3] Group 3: Product Profile - ATI-052 targets TSLP at the top of the inflammatory cascade and blocks downstream IL-4 and IL-13, which are critical cytokines in Th2-mediated inflammation [4] - The antibody utilizes the same TSLP antigen-binding fragment as bosakitug (ATI-045) but is engineered for tighter binding to the neonatal Fc receptor (FcRn), potentially extending its half-life [4] Group 4: Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, with a robust R&D pipeline [5]

Aclaris Therapeutics (ACRS) FY Conference Summary Company Overview - Aclaris Therapeutics is an immuno-inflammatory R&D company with a focus on developing biologic drugs, particularly in dermatologic and respiratory indications [1][2][4]. Key Developments - Aclaris has undergone significant changes in the past year, including the acquisition of two assets, Sacatug and ATI-52, which are expected to enhance its pipeline [4][7]. - The company has three clinical assets currently in development: - IDKJAK3, which is completing an atopic dermatitis (AD) study and will move into alopecia areata later this year [5][6]. - TSLP antibody (Vosacutog), which has initiated a global Phase II trial [6]. - A bispecific antibody targeting TSLP and IL4R, cleared by the FDA, with a Phase I trial starting soon [6][12]. Pipeline and Clinical Trials - The TSLP antibody has shown a residence time of 400 hours on the target, significantly longer than competitors, which is crucial for neutralizing TSLP effectively [14][15]. - Aclaris aims to differentiate Vosacutog in the AD space, where it has shown promising early data, including a 94% EZ75 response rate in open-label trials [15][24]. - The company is also exploring respiratory indications, with data sharing rights from a Chinese partner conducting Phase II trials in severe asthma and chronic rhinosinusitis [21][26]. Strategic Focus - Aclaris is focusing on immuno-inflammatory diseases, particularly in dermatology and respiratory conditions, as part of its strategic direction [13][28]. - The decision to bifurcate development efforts between dermatology and respiratory indications is driven by the need for significant capital investment in later-stage respiratory studies, which Aclaris is currently not positioned to undertake alone [27][28]. Financial Position - Aclaris currently has over $190 million in cash, extending its runway through mid-2028, allowing it to pursue key catalysts in its pipeline [75][76]. - The company emphasizes a shareholder-friendly approach and efficient operational decisions to maintain financial health while advancing its clinical programs [75][76]. Future Outlook - Aclaris is optimistic about upcoming data readouts over the next 18 months, which are critical for the company's success [78][79]. - The company is also developing a discovery portfolio of biologic assets, indicating a commitment to innovation and long-term growth [11][12][79]. Conclusion - Aclaris Therapeutics is positioned to leverage its differentiated assets in the immuno-inflammatory space, with a strong focus on clinical development and strategic partnerships to enhance its market presence and drive future growth [76][78].

Summary of Aclaris Therapeutics (ACRS) Conference Call Company Overview - Aclaris Therapeutics is a clinical stage biopharmaceutical company focused on both large and small molecule targets, with a proprietary drug discovery engine and a chemical library [3][5] Key Clinical Assets - **O-2138**: An oral small molecule targeting ITK and JAK3, with unique pharmacology [4] - **O-45**: A TSLP monoclonal antibody currently in Phase 2 trials for atopic dermatitis (AD), with a high response rate observed in previous studies [6][10] - **Bispecific Antibody**: Recently received IND approval and will begin Phase 1 SADMAD work [4][42] Pipeline Updates - Aclaris has three clinical stage assets and has extended its cash runway to mid-2028 with $191 million on the balance sheet [5][58] - The Phase 2 study for O-45 is designed to replicate previous high efficacy results with a placebo control [6][10] - The company is optimistic about the potential of O-45, citing its potency compared to competitors [12][20] Efficacy and Safety Data - The Phase 2 study for O-45 aims to demonstrate robust efficacy and safety, with primary endpoints including EZ75 response and IgA zero one response [17][19] - The company has confidence in the drug's performance based on extensive preclinical work and previous clinical data [15][26] Strategic Partnerships and Market Position - Aclaris is exploring partnerships for its respiratory franchise, particularly in China, where it has seen positive preliminary data [23][24] - The company is receiving inbound interest from potential partners due to the advanced stage of its assets [28][29] Future Directions - Aclaris plans to advance its ITK selective inhibitor into clinical trials in 2026, targeting indications like alopecia areata and other T2-related diseases [34][36] - The company is also developing bispecific constructs that utilize its TSLP mAb, aiming for enhanced efficacy in treating various conditions [57] Financial Outlook - Aclaris is well-capitalized to support its pipeline through 2027, with plans to monetize its IP estate and seek nondilutive capital [54][58] - The current cash flow supports multiple ongoing and upcoming clinical trials, including Phase 2 for AD and alopecia areata, and Phase 1 for the bispecific antibody [55][56] Conclusion - Aclaris Therapeutics is positioned for significant growth with a robust pipeline and strategic focus on partnerships, aiming to address unmet medical needs in dermatology and respiratory diseases [58]

Core Insights - Aclaris Therapeutics has initiated a Phase 2 trial for bosakitug, an investigational monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe atopic dermatitis (AD) [1][2] - The trial aims to evaluate the efficacy and safety of bosakitug, with top line results expected 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 [7] - The company has a robust R&D engine and a multi-stage portfolio of product candidates [7] Product Details - Bosakitug (ATI-045) is a humanized anti-TSLP monoclonal antibody that blocks TSLP's interaction with its receptor, preventing the release of proinflammatory cytokines [3] - It exhibits high affinity, potency, and a long residence time, potentially allowing for extended dosing intervals [3] Clinical Trial Information - The Phase 2 trial is randomized, double-blind, and placebo-controlled, involving approximately 90 patients [2] - Primary endpoint is the percent change in Eczema Area and Severity Index (EASI) at week 24, with secondary endpoints including various EASI responses and safety assessments [2] Atopic Dermatitis Context - Atopic dermatitis affects approximately 10 million children and 17 million adults in the U.S., with over 200 million affected worldwide [5] - The condition significantly impacts quality of life, with many patients experiencing moderate to severe symptoms [5] TSLP Significance - TSLP is a key cytokine in the Type 2 immune response, driving inflammation in allergic and inflammatory diseases [4] - It activates downstream targets involved in the inflammatory cascade, making it a relevant therapeutic target [4]

Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [3] - The company has a multi-stage portfolio of product candidates supported by a robust R&D engine [3] Upcoming Events - Aclaris will participate in two healthcare conferences in June 2025: the Jefferies Global Healthcare Conference on June 4 at 10:30 AM EDT and the Goldman Sachs Global Healthcare Conference on June 11 at 1:20 PM EDT [5] - A live and archived webcast of both events will be available on the Aclaris website for at least 30 days [2]

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 virtual fireside chat during the HC Wainwright "HCW@Home" series on May 16, 2025 [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] Event Details - The virtual fireside chat is scheduled for May 16, 2025, at 1:00 PM EDT, with a live and archived webcast available on the Aclaris website [2]

Financial Performance - The company reported a net loss of $15.1 million for the three months ended March 31, 2025, and a net loss of $132.1 million for the year ended December 31, 2024, with an accumulated deficit of $917.9 million as of March 31, 2025[121]. - Total revenue for the three months ended March 31, 2025, was $1.455 million, a decrease of 39.2% from $2.398 million in the same period of 2024[160]. - Contract research revenue decreased to $0.445 million in Q1 2025 from $0.657 million in Q1 2024, driven by lower overall hours billed[161]. - Licensing revenue fell to $1.010 million in Q1 2025 from $1.741 million in Q1 2024, primarily due to lower royalties following the sale of a portion of OLUMIANT® royalty payments[162]. - The net loss for the three months ended March 31, 2025, was $15.085 million, an improvement from a net loss of $16.941 million in the same period of 2024[160]. - Cash and cash equivalents increased to $30.3 million as of March 31, 2025, compared to $24.6 million as of December 31, 2024[178]. - The company had cash, cash equivalents, and marketable securities totaling $190.5 million as of March 31, 2025[176]. - Net cash used in operating activities decreased to $13.057 million in Q1 2025 from $20.815 million in Q1 2024, primarily due to a decrease in cash used for accounts payable[180]. - The company anticipates incurring net losses in the near term as it continues the development of its product candidates[183]. - The company believes its existing cash and marketable securities are sufficient to fund operations for more than 12 months from the date of the financial statements[186]. - The company has a contingent consideration liability balance of $9.0 million as of March 31, 2025, related to the Confluence Agreement[192]. - The aggregate remaining lease payment obligation for two spaces is $3.1 million as of March 31, 2025[191]. Research and Development - Bosakitug demonstrated a positive pharmacodynamic, safety, and efficacy profile in a Phase 2a trial, with 94% of patients achieving a 75% improvement in the Eczema Area and Severity Index (EASI) at week 26[100]. - The company plans to initiate a Phase 2 trial for bosakitug in approximately 90 patients with moderate to severe atopic dermatitis in Q2 2025[101]. - ATI-2138 was well tolerated in a Phase 1 trial with 60 healthy volunteers, showing dose-dependent inhibition of ITK and JAK3 biomarkers, with no serious adverse events reported[104]. - The Phase 2a trial for ATI-2138 has been completed, and top-line data is expected to be announced in June 2025[105]. - Lepzacitinib met its primary efficacy endpoint in a Phase 2b trial, showing a 69.7% improvement in EASI score at week 4 compared to 58.7% in the vehicle group (p=0.035)[111]. - The company discontinued the development of zunsemetinib for immuno-inflammatory diseases in 2023 following Phase 2 trial results[139]. Partnerships and Agreements - The company entered into an exclusive license agreement with Biosion in November 2024, paying $30.0 million in upfront cash and issuing warrants for 14,281,985 shares of common stock[124][125]. - The company agreed to pay up to $125 million upon achieving specified regulatory milestones and up to $795 million upon achieving specified sales milestones under the Biosion Agreement[126]. - The company received an upfront payment of $26.5 million from OMERS in exchange for a portion of future royalty payments related to OLUMIANT® for the treatment of alopecia areata[129]. - The company entered into a license agreement with Sun Pharmaceutical Industries, which includes mid single-digit tiered royalties based on net sales of deuruxolitinib[131]. - The company recognized $1.0 million of licensing revenue during the three months ended March 31, 2025, all payable to third parties[134]. - The company agreed to pay up to $75 million in contingent consideration based on regulatory and commercial milestones under the Confluence Agreement[138]. Operational Challenges - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances its product candidates through development[121]. - Macroeconomic conditions, including inflation and geopolitical conflicts, may negatively impact the company's growth and results of operations[123]. - The probability of achieving regulatory milestones ranges between 17% and 40% as of March 31, 2025[158]. - The company recorded a charge of $0.3 million to the contingent consideration liability during the three months ended March 31, 2025, primarily due to the passage of time[159]. Workforce and Organizational Changes - The company approved a workforce reduction of approximately 46% in December 2023, with severance payments of $0.2 million made during the three months ended March 31, 2025[140]. Business Segments - The therapeutics segment focuses on developing innovative therapies for immuno-inflammatory diseases, while the contract research segment generates revenue from laboratory services[195].