[Executive Summary & Company Overview](index=1&type=section&id=Executive%20Summary%20%26%20Company%20Overview) [Introduction and Key Highlights](index=1&type=section&id=Introduction%20and%20Key%20Highlights) Aclaris Therapeutics reported positive Q2 2025 results, highlighting strong clinical execution and a cash runway into H2 2028 - Positive Phase 2a results for **ATI-2138** confirmed tolerability, showed strong efficacy, and validated **ITK as a therapeutic target**[1](index=1&type=chunk)[2](index=2&type=chunk)[3](index=3&type=chunk) - Advanced **Bosakitug (ATI-045)** into Phase 2 trial in Atopic Dermatitis (AD), with patient dosing underway[1](index=1&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - Initiated dosing in Phase 1a/1b clinical program for **ATI-052**[1](index=1&type=chunk)[5](index=5&type=chunk) - Strong cash runway expected to fund operations into **H2 2028**, with exploration of additional non-dilutive opportunities[1](index=1&type=chunk)[2](index=2&type=chunk)[7](index=7&type=chunk) [Pipeline Updates](index=1&type=section&id=Pipeline%20Updates) [ATI-2138 (ITK/JAK3 Inhibitor) Phase 2a Trial Results](index=1&type=section&id=ATI-2138%20(ITK%2FJAK3%20Inhibitor)%20Phase%202a%20Trial%20Results) ATI-2138's Phase 2a trial met endpoints, confirming favorable tolerability and efficacy in AD, validating ITK as a therapeutic target - Achieved **Primary and Key Secondary Endpoints** in Phase 2a Trial of **ATI-2138**[3](index=3&type=chunk) - Trial confirmed **favorable tolerability profile** and demonstrated **clinically meaningful improvements** in disease severity for moderate-to-severe AD patients[3](index=3&type=chunk) - Results validate **ITK as a therapeutic target**, suggesting **ATI-2138** may achieve comparable efficacy to approved JAK inhibitors with improved tolerability and without significant safety risks[3](index=3&type=chunk) [Bosakitug (ATI-045) Anti-TSLP Monoclonal Antibody Phase 2 Trial](index=1&type=section&id=Bosakitug%20(ATI-045)%20Anti-TSLP%20Monoclonal%20Antibody%20Phase%202%20Trial) Dosing initiated for **Bosakitug (ATI-045)** Phase 2 trial in ~90 moderate-to-severe AD patients, with top-line results expected in H2 2026 - Initiated dosing in Phase 2 Trial of potential best-in-class investigational Anti-TSLP Monoclonal Antibody **Bosakitug**[3](index=3&type=chunk) - The global Phase 2 trial will evaluate **bosakitug** in approximately **90 patients** with moderate-to-severe AD[4](index=4&type=chunk) - Top-line results for the **Bosakitug** Phase 2 trial are expected in **H2 2026**[4](index=4&type=chunk) [ATI-052 Anti-TSLP/IL-4R Bispecific Antibody Phase 1a/1b Program](index=3&type=section&id=ATI-052%20Anti-TSLP%2FIL-4R%20Bispecific%20Antibody%20Phase%201a%2F1b%20Program) Dosing commenced for **ATI-052** Phase 1a/1b program, with Phase 1a results by early 2026 and Phase 1b results in H2 2026 - Initiated dosing in Phase 1a/1b Program for potential best-in-class investigational Bispecific Anti-TSLP/IL-4R Antibody **ATI-052**[5](index=5&type=chunk) - Phase 1a evaluates single and multiple ascending doses in healthy adults, with completion by **year-end 2025** and top-line results in **early 2026**[5](index=5&type=chunk) - Phase 1b proof-of-concept portion in up to two indications is expected to follow Phase 1a, with top-line results in **H2 2026**[5](index=5&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) [Liquidity and Capital Resources](index=3&type=section&id=Liquidity%20and%20Capital%20Resources) Aclaris reported **$180.9 million** cash as of June 30, 2025, projecting funding into H2 2028 and exploring non-dilutive opportunities | Metric | As of June 30, 2025 (in millions) | As of December 31, 2024 (in millions) | | :--------------------------------- | :-------------------------------- | :------------------------------------ | | Cash, cash equivalents and marketable securities | **$180.9** | **$203.9** | - The Company believes its cash, cash equivalents, and marketable securities will fund operations into **H2 2028**[2](index=2&type=chunk)[7](index=7&type=chunk)[11](index=11&type=chunk) - Aclaris is assessing potential **non-dilutive opportunities** to extend the cash runway further[2](index=2&type=chunk)[11](index=11&type=chunk) [Senior Leadership Update](index=3&type=section&id=Senior%20Leadership%20Update) Aclaris appointed **Roland Kolbeck, Ph.D.**, as Chief Scientific Officer; **Joe Monahan, Ph.D.**, transitions to advisor until Q1 2026 retirement - **Roland Kolbeck, Ph.D.** has been appointed as Chief Scientific Officer[11](index=11&type=chunk) - **Joe Monahan, Ph.D.** will remain as Special Scientific Advisor to the CEO through **Q1 2026** as part of his planned retirement[11](index=11&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) [Second Quarter and Year-to-Date 2025 Financial Summary](index=3&type=section&id=Second%20Quarter%20and%20Year-to-Date%202025%20Financial%20Summary) Aclaris reported increased net loss for Q2 and YTD 2025, driven by higher R&D and contingent consideration, with revenue decreasing due to royalty sale [Net Loss](index=3&type=section&id=Net%20Loss) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YTD 2025 (in millions) | YTD 2024 (in millions) | | :------- | :-------------------- | :-------------------- | :--------------------- | :--------------------- | | Net Loss | **$(15.4)** | **$(11.0)** | **$(30.5)** | **$(27.9)** | - Net loss increased by **$4.4 million** for Q2 2025 and by **$2.6 million** for the six months ended June 30, 2025, compared to prior year periods[8](index=8&type=chunk) [Total Revenue](index=3&type=section&id=Total%20Revenue) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YTD 2025 (in millions) | YTD 2024 (in millions) | | :----------- | :-------------------- | :-------------------- | :--------------------- | :--------------------- | | Total Revenue | **$1.8** | **$2.8** | **$3.2** | **$5.2** | - Total revenue decreased for both comparison periods, primarily driven by the sale of a portion of royalty payments to OCM IP Healthcare Portfolio IP in **July 2024**[9](index=9&type=chunk) [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YTD 2025 (in millions) | YTD 2024 (in millions) | | :---------------- | :-------------------- | :-------------------- | :--------------------- | :--------------------- | | R&D Expenses | **$11.4** | **$8.8** | **$23.0** | **$18.6** | - R&D expenses increased primarily due to product candidate manufacturing costs, preclinical development, and clinical development expenses for **bosakitug** and **ATI-052**[10](index=10&type=chunk) - For the six-month period, clinical development expenses for **ATI-2138** also contributed to the increase, partially offset by reduced **zunsemetinib** development expenses[10](index=10&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YTD 2025 (in millions) | YTD 2024 (in millions) | | :---------------- | :-------------------- | :-------------------- | :--------------------- | :--------------------- | | G&A Expenses | **$5.4** | **$4.8** | **$11.5** | **$11.6** | - Q2 2025 G&A expenses increased due to higher personnel expenses from increased headcount[11](index=11&type=chunk) - YTD 2025 G&A expenses decreased primarily due to lower personnel expenses resulting from lower termination benefits[12](index=12&type=chunk) [Revaluation of Contingent Consideration](index=5&type=section&id=Revaluation%20of%20Contingent%20Consideration) | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | YTD 2025 (in millions) | YTD 2024 (in millions) | | :--------------------------------- | :-------------------- | :-------------------- | :--------------------- | :--------------------- | | Revaluation of contingent consideration | **$1.5** | **$0.2** | **$1.8** | **$3.0** | - The Q2 2025 charge increased due to changes in probability of success for certain product candidates and lower discount rates[13](index=13&type=chunk) - The YTD 2025 charge decreased due to changes in estimated sales levels and probability of success for certain product candidates during the six months ended June 30, 2024[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed consolidated statements of operations detail revenues, costs, and expenses for Q2 and YTD 2025/2024, showing increased net loss and expense changes | | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | **Revenues:** | | | | | | Contract research | **$442** | **$625** | **$887** | **$1,281** | | Licensing | **$1,335** | **$2,141** | **$2,345** | **$3,882** | | **Total revenue** | **$1,777** | **$2,766** | **$3,232** | **$5,163** | | **Costs and expenses:** | | | | | | Cost of revenue | **$515** | **$624** | **$1,021** | **$1,433** | | Research and development | **$11,449** | **$8,759** | **$23,033** | **$18,604** | | General and administrative | **$5,386** | **$4,752** | **$11,525** | **$11,596** | | Licensing | **$1,335** | **$1,285** | **$2,345** | **$2,316** | | Revaluation of contingent consideration | **$1,500** | **$200** | **$1,800** | **$3,000** | | **Total costs and expenses** | **$20,185** | **$15,620** | **$39,724** | **$36,949** | | **Loss from operations** | **$(18,408)** | **$(12,854)** | **$(36,492)** | **$(31,786)** | | **Other income:** | | | | | | Interest income | **$2,018** | **$1,868** | **$4,184** | **$3,859** | | Non-cash royalty income | **$961** | **$—** | **$1,794** | **$—** | | **Total other income** | **$2,979** | **$1,868** | **$5,978** | **$3,859** | | **Net loss** | **$(15,429)** | **$(10,986)** | **$(30,514)** | **$(27,927)** | | Net loss per share, basic and diluted | **$(0.13)** | **$(0.15)** | **$(0.25)** | **$(0.39)** | | Weighted average common shares outstanding, basic and diluted | **122,580,967** | **71,291,400** | **122,486,162** | **71,183,129** | [Selected Consolidated Balance Sheet Data](index=7&type=section&id=Selected%20Consolidated%20Balance%20Sheet%20Data) Balance sheet data shows decreases in cash, total assets, liabilities, and equity from December 31, 2024, to June 30, 2025 | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :--------------------------- | :------------------------------- | | Cash, cash equivalents and marketable securities | **$180,890** | **$203,896** | | Total assets | **$189,147** | **$220,327** | | Total current liabilities | **$26,839** | **$31,596** | | Total liabilities | **$57,408** | **$64,773** | | Total stockholders' equity | **$131,739** | **$155,554** | | Common stock outstanding | **108,328,794** | **107,850,124** | [Selected Consolidated Cash Flow Data](index=8&type=section&id=Selected%20Consolidated%20Cash%20Flow%20Data) For YTD June 30, 2025, Aclaris reported **$23.05 million** net cash outflow from operations, an improvement from prior year despite increased net loss | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Net loss | **$(30,514)** | **$(27,927)** | | Depreciation and amortization | **$242** | **$485** | | Stock-based compensation expense | **$6,598** | **$4,992** | | Revaluation of contingent consideration | **$1,800** | **$3,000** | | Changes in operating assets and liabilities | **$(1,176)** | **$(13,687)** | | **Net cash used in operating activities** | **$(23,050)** | **$(33,137)** | - Net cash used in operating activities decreased from **$33.137 million** in YTD 2024 to **$23.050 million** in YTD 2025[21](index=21&type=chunk) [About Aclaris Therapeutics, Inc.](index=5&type=section&id=About%20Aclaris%20Therapeutics%2C%20Inc.) [Company Overview](index=5&type=section&id=Company%20Overview) Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel product candidates for immuno-inflammatory diseases - **Aclaris Therapeutics, Inc.** is a clinical-stage biopharmaceutical company[14](index=14&type=chunk) - The company develops novel product candidates for **immuno-inflammatory diseases** where patients lack satisfactory treatment options[14](index=14&type=chunk) - Aclaris has a **multi-stage portfolio** of product candidates supported by a robust R&D engine[14](index=14&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) [Forward-Looking Statements Disclaimer](index=5&type=section&id=Forward-Looking%20Statements%20Disclaimer) Statements not describing historical facts are forward-looking and subject to risks and uncertainties, including those detailed in SEC filings - Statements not describing historical facts are **forward-looking statements**, subject to risks and uncertainties[15](index=15&type=chunk) - Risks include uncertainties in clinical trials, reliance on third parties, ability to form partnerships, macroeconomic environment, and other risks detailed in **SEC filings**[15](index=15&type=chunk) - Aclaris assumes **no obligation to update** any forward-looking statements[15](index=15&type=chunk) [Aclaris Therapeutics Contacts](index=5&type=section&id=Aclaris%20Therapeutics%20Contacts) [Investor and Media Relations](index=5&type=section&id=Investor%20and%20Media%20Relations) Contact information provided for Aclaris Therapeutics' CFO, Kevin Balthaser, and SVP of Corporate Communications and Investor Relations, Will Roberts - Contact information for **Kevin Balthaser**, Chief Financial Officer, and **Will Roberts**, Senior Vice President, Corporate Communications and Investor Relations, is provided[16](index=16&type=chunk)

Core Viewpoint - Aclaris Therapeutics, Inc. reported positive clinical results from its Phase 2a trial of the ITK/JAK3 inhibitor ATI-2138, confirming its tolerability and efficacy, while also validating ITK as a therapeutic target. The company has a strong cash runway expected to fund operations into the second half of 2028, allowing for continued development of its innovative therapies for immuno-inflammatory diseases [1][2]. Pipeline Developments - The company advanced the anti-TSLP monoclonal antibody Bosakitug (ATI-045) into a Phase 2 trial for atopic dermatitis (AD), with patient dosing currently underway [5]. - Dosing has been initiated in the Phase 1a/1b clinical program for the bispecific antibody ATI-052, with expectations to complete the Phase 1a portion by the end of 2025 and provide results in early 2026 [5][6]. Financial Performance - For Q2 2025, Aclaris reported a net loss of $15.4 million, compared to a net loss of $11.0 million in Q2 2024. The total revenue for Q2 2025 was $1.8 million, down from $2.8 million in Q2 2024 [8][9]. - Research and development expenses increased to $11.4 million for Q2 2025, up from $8.8 million in the same period last year, driven by costs associated with clinical development [10]. - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $180.9 million, down from $203.9 million at the end of 2024, but still sufficient to fund operations into the second half of 2028 [7][20]. Leadership Update - Aclaris appointed Roland Kolbeck, Ph.D., as the new Chief Scientific Officer, succeeding Joe Monahan, Ph.D., who will transition to a Special Scientific Advisor role [6].

Core Viewpoint - Aclaris Therapeutics (ACRS) is anticipated to report a year-over-year increase in earnings despite lower revenues, which could significantly influence its stock price based on actual results compared to estimates [1][2]. Financial Performance Expectations - The consensus estimate indicates Aclaris is expected to post a quarterly loss of $0.13 per share, reflecting a year-over-year change of +13.3% [3]. - Revenues are projected to be $1.55 million, representing a decline of 44% from the same quarter last year [3]. Estimate Revisions and Predictions - Over the last 30 days, the consensus EPS estimate has been revised 1.41% higher, indicating a positive reassessment by analysts [4]. - Aclaris has an Earnings ESP of +10.00%, suggesting analysts have become more optimistic about the company's earnings prospects [12]. Historical Performance and Trends - In the last reported quarter, Aclaris was expected to incur a loss of $0.17 per share but actually reported a loss of $0.12, resulting in a positive surprise of +29.41% [13]. - Over the past four quarters, Aclaris has exceeded consensus EPS estimates three times [14]. Industry Context - Another player in the Zacks Medical - Drugs industry, Zoetis (ZTS), is expected to report earnings of $1.61 per share for the same quarter, indicating a year-over-year change of +3.2% [18]. - Zoetis's revenues are expected to reach $2.4 billion, up 1.7% from the previous year [18].

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.

ATI-2138 Pharmacology and Preclinical Data - ATI-2138 is a highly potent dual inhibitor of ITK and JAK3, with IC50 values of 0.2 nM for ITK and 0.5 nM for JAK3 [6] - ATI-2138 is 44.4 times more potent than ritlecitinib in inhibiting anti-CD3 induced IFNγ production (ITK) and 5.4 times more potent for inhibiting JAK3 dependent IL-2 induced IFNγ production in human whole blood [14] - ATI-2138 is 15 to 38 times more potent than CPI-818 in inhibiting the ITK enzyme activity [18] Phase 2a Clinical Trial - Safety and Efficacy - ATI-2138 was generally well-tolerated in the Phase 2a trial, with no serious adverse events (SAEs) or treatment-emergent adverse events (TEAEs) reported [28] - In the Phase 2a trial, the mean improvement in EASI score at 12 weeks was 61%, and the median improvement was 77% [30] - Excluding an outlier, the mean improvement in EASI score at 12 weeks was 77%, and the median improvement was 82% [37] - At week 12, 63% of patients experienced a ≥4-point improvement in worst itch in the past 24 hours (PP-NRS) [43] Phase 2a Clinical Trial - Pharmacodynamic Assessments - Phase 2a results showed approximately 90% inhibition of both IL2 and IFNγ mRNA observed 1 hour post-dose (~peak) across the 12 weeks of dosing in ITK-TCR Assay [48] - Near complete ATI-2138 ITK target occupancy observed one hour post-dose (~peak) across the 12 weeks of dosing [52] - Phase 2a results showed approximately 80% inhibition of JAK3-induced IFNγ observed 1 hour post dose (~peak) [58] Future Development Plans - Aclaris intends to further develop ATI-2138 in alopecia areata and is exploring other indications relevant to the mechanism of action [78] - Preclinical work is ongoing for next-generation ITK inhibitors, with Aclaris expecting to provide the basis for new INDs starting in 2026 [78]

Core Insights - Aclaris Therapeutics announced positive top-line results from its Phase 2a trial of ATI-2138, indicating a favorable tolerability profile and comparable efficacy to approved therapies for moderate-to-severe atopic dermatitis [1][2][13] Group 1: Trial Overview - The Phase 2a trial was an open-label, single-arm study involving 14 patients with moderate-to-severe atopic dermatitis, focusing on safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 administered at 10mg BID for 12 weeks [14] - The trial confirmed the strong tolerability profile of ATI-2138, with no severe adverse events reported and most adverse events being mild [6][12] Group 2: Efficacy Results - The mean improvement in Eczema Area and Severity Index (EASI) score at week 12 was 60.5%, with a median improvement of 76.8% among patients receiving ATI-2138 [12] - At week 12, 62.5% of patients experienced a clinically meaningful ≥4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) [9] - Improvements in EASI scores were observed as early as week 1, with significant reductions noted at weeks 4, 8, and 12 [12] Group 3: Pharmacodynamic Results - Pharmacodynamic analyses demonstrated strong downregulation of key inflammatory markers associated with ITK, including Th2 and Th1/Th17-related markers, indicating the therapeutic potential of ITK inhibition [3][10] - Near complete and sustained ITK target occupancy was observed, with reductions in multiple inflammatory pathways linked to ITK [10] Group 4: Future Development Plans - Aclaris plans to further develop ATI-2138 for alopecia areata and explore other indications relevant to its mechanism of action, with ongoing preclinical work for next-generation ITK inhibitors expected to lead to new INDs starting in 2026 [13][16]

Core Insights - Aclaris Therapeutics, Inc. has appointed Roland Kolbeck, Ph.D. as the new Chief Scientific Officer, succeeding Joe Monahan, Ph.D., who will transition to a Special Scientific Advisor role until March 2026 as part of his planned retirement [1][2] - Dr. Kolbeck brings nearly three decades of experience in R&D leadership and a strong track record in drug development, particularly in immuno-inflammatory diseases [2][3] - The company is focused on developing a pipeline of novel product candidates, including next-generation kinase and cytokine signaling pathway inhibitors and potential first-in-class bispecific antibodies [1][2] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options [3] - The company has a multi-stage portfolio powered by a robust R&D engine, indicating a strong commitment to innovation and therapeutic development [3]

Clinical Assets & Pipeline - Bosakitug (ATI-045) is a uniquely potent monoclonal antibody targeting TSLP, currently in a two-arm placebo-controlled Phase 2 trial initiated in Q2 2025 [6] - ATI-052, a bispecific antibody targeting both TSLP and IL-4R, has initiated a Phase 1a/1b SAD/MAD program in Q2 2025 [6] - ATI-2138, a potent and selective oral inhibitor of ITK/JAK3, expects top-line results from a Phase 2a OL trial in July 2025 [6] - The company is conducting discovery/preclinical evaluation for novel ITK inhibitors and BsAbs, with new INDs expected to start in 2026 [6] - Aclaris expects Phase 2a top-line results for ATI-2138 in Atopic Dermatitis in July 2025 [8, 11] Financial Position - Aclaris has a strong balance sheet and is expected to fund operations through the first half of 2028 [6] - The company anticipates opportunities for additional non-dilutive financing and development partners [6] - As of Q1 2025, Aclaris has $1905 million in cash, cash equivalents, and marketable securities [86] Bosakitug (ATI-045) Data - Bosakitug is reported to be >60x more potent than Tezepelumab in hPBMC CCL17 Inhibition [17] - Phase 2a trial data showed that 94% of patients achieved EASI 75 at Week 26 [37] - Phase 2a trial data showed that 65% of patients achieved EASI 90 at Week 26 [37] - Phase 2a trial data showed that 24% of patients achieved EASI 100 at Week 26 [37] - Phase 2a trial data showed that 88% of patients achieved IGA 0/1 at Week 26 [37] ATI-052 Data - ATI-052 is reported to be 3-5x more potent than the combination of Tezepelumab + Dupilumab on CCL17 release [54]

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]