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].

Core Viewpoint - Aclaris Therapeutics reported a quarterly loss of $0.12 per share, outperforming the Zacks Consensus Estimate of a loss of $0.17, and showing improvement from a loss of $0.24 per share a year ago, indicating a positive earnings surprise of 29.41% [1] Financial Performance - The company posted revenues of $1.46 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 65.15%, compared to revenues of $2.4 million in the same quarter last year [2] - Over the last four quarters, Aclaris has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - Aclaris shares have declined approximately 49.6% since the beginning of the year, contrasting with the S&P 500's decline of 4.3% [3] - The current Zacks Rank for Aclaris is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.19 on revenues of $4.28 million, and for the current fiscal year, it is -$0.71 on revenues of $17.33 million [7] - The trend of estimate revisions for Aclaris is mixed, which could change following the recent earnings report [6] Industry Context - The Medical - Drugs industry, to which Aclaris belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Plus Therapeutics, is expected to report a quarterly loss of $0.17 per share, with a year-over-year change of +77.3% [9]

Financial Performance - Aclaris reported a net loss of $15.1 million for Q1 2025, a decrease from a net loss of $16.9 million in Q1 2024[14] - Total revenue for Q1 2025 was $1.5 million, down from $2.4 million in Q1 2024, primarily due to reduced royalty payments[14] - Net loss for Q1 2025 was $15,085,000, an improvement from a net loss of $16,941,000 in Q1 2024[26] - Depreciation and amortization expenses decreased to $128,000 from $243,000 year-over-year[26] - Stock-based compensation expense increased to $3,535,000 compared to $2,089,000 in the previous year[26] - Revaluation of contingent consideration was $300,000, down from $2,800,000 in the prior year[26] - Changes in operating assets and liabilities resulted in a cash outflow of $1,935,000, an improvement from $9,006,000 in Q1 2024[26] - Net cash used in operating activities was $13,057,000, compared to $20,815,000 in the same quarter last year[26] Cash Position and Runway - Aclaris ended Q1 2025 with $190.5 million in cash, cash equivalents, and marketable securities, down from $203.9 million at the end of 2024[13] - The expected cash runway has been extended through the first half of 2028, fully funding preclinical and clinical development plans[9] Research and Development - Research and development expenses increased to $11.6 million in Q1 2025 from $9.8 million in the prior year, driven by costs associated with the bosakitug program[15] - Aclaris plans to initiate a Phase 2 trial for bosakitug in atopic dermatitis with approximately 90 patients in Q2 2025[3] - Top line results from the Phase 2a trial of ATI-2138 in atopic dermatitis are expected in June 2025[6] - The IND application for ATI-052 was cleared by the FDA, with plans to initiate a Phase 1 trial in Q2 2025[7] - Aclaris is exploring partnerships for the global development of bosakitug in respiratory indications[10] - The company aims to develop next-generation ITK inhibitors and bispecific antibodies targeting cytokine pathways, with new IND submissions expected starting in 2026[11]