Aclaris Therapeutics 2025 R&D Day Summary Company Overview - **Company**: Aclaris Therapeutics (NasdaqGS: ACRS) - **Event**: 2025 R&D Day - **Date**: October 14, 2025 - **Location**: New York Key Industry and Company Insights 1. Upcoming Milestones - 2026 is projected to be a significant year with four anticipated readouts across the portfolio and a new IND for next-gen ITK-selective compounds [5][20] - The company currently has three clinical programs and will expand to four in 2026, focusing on both oral and antibody therapies [5][6] 2. Product Pipeline Highlights - **Bosakatug (ATI-045)**: A TSLP monoclonal antibody in Phase 2 for moderate to severe atopic dermatitis, with readout expected in the second half of 2026 [11] - **ATI-052**: A bispecific targeting TSLP and IL4R, currently in the MAD portion of clinical trials, with data expected in early Q1 2026 [11][12] - **ATI-2138**: A dual ITK/JAK3 inhibitor showing promising efficacy in atopic dermatitis, currently in Phase 2 trials [12][51] 3. Market Potential - The company is targeting large markets in immunology and inflammation, particularly in conditions like atopic dermatitis and asthma, which are expected to grow significantly [13][29] - The global healthcare spend in 2024 was approximately $200 billion, projected to double by 2033, indicating a growing market for Aclaris' products [29] 4. Competitive Positioning - Aclaris aims to differentiate itself by developing oral small molecules and bispecific antibodies that can target multiple pathways, potentially leading to better efficacy and safety profiles compared to existing treatments [9][14] - The company emphasizes its ability to manage capital effectively, with a runway extending into the second half of 2028 [9][20] 5. Scientific and Technical Innovations - Aclaris utilizes a proprietary KINect platform to develop small molecules targeting previously inaccessible kinases, with a focus on covalent inhibitors and molecular glues [25][27] - The company is also advancing bispecific antibodies, which have shown success in oncology, into the autoimmune and inflammation space [29][30] 6. Clinical Development Strategy - Aclaris is focusing on developing compounds with high potency and specificity, aiming to reduce dosing frequency and improve patient compliance [30][36] - The company is leveraging its state-of-the-art R&D capabilities to profile both internally developed and in-licensed molecules, ensuring a competitive edge in drug development [36] 7. Efficacy and Safety Data - Preliminary data from ATI-2138 trials indicate a favorable safety profile and significant efficacy in reducing symptoms of atopic dermatitis, with a strong pharmacodynamic response observed [51][52] - The company is committed to understanding the pharmacokinetics and pharmacodynamics of its compounds to optimize dosing and therapeutic outcomes [52][54] Additional Important Insights - Aclaris is positioned to address unmet clinical needs in the autoimmune and inflammation space, with a focus on tailoring therapies to diverse patient populations [29][30] - The company has a robust pipeline with multiple data events scheduled throughout 2026 and into 2027, indicating a proactive approach to clinical development [20][36] This summary encapsulates the key points discussed during the Aclaris Therapeutics 2025 R&D Day, highlighting the company's strategic direction, product pipeline, and market opportunities.

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Company Overview and Strategy - Aclaris is developing therapeutic franchises to address gaps in important Immune and Inflammatory (I&I) diseases, focusing on patient-driven innovation [1, 8] - The company anticipates having three clinical programs in 2025 and four in 2026, with 2026 being an important year for potential inflection points [11] - Aclaris expects its cash runway to extend into the second half of 2028, supporting its preclinical and clinical development plans [11, 14] Pipeline and Programs - Aclaris's pipeline includes Bosakitug (ATI-045), a monoclonal antibody targeting TSLP, ATI-052, a bispecific antibody targeting both TSLP and IL-4Rα, and ATI-2138, an oral inhibitor of ITK/JAK3 [14] - ATI-2138's Phase 2a open-label trial in Atopic Dermatitis (AD) achieved primary and key secondary endpoints, validating ITK as a therapeutic target; at week 12, 63% of patients experienced a ≥4-point improvement in worst itch [14, 103] - Bosakitug is currently in a two-arm placebo-controlled Phase 2 trial, while ATI-052 is in a Phase 1a/1b SAD MAD program with ongoing dosing [14] - The company is developing next-generation ITK selective inhibitors and bispecific antibodies, with potential for IND submissions starting in 2026 [14, 61] Market Opportunity and Technology - The total addressable market for select Th1, Th2, and Th17-mediated diseases is projected to be in the range of $0 to $70 billion globally from 2028-2034 [16] - Aclaris is leveraging its KINect® Technology Platform to target approximately 60% of the Kinome, with the annual sales of kinase drugs in 2024 at $62.8 billion and a market opportunity of $88.6 billion in 2029 [28, 30] - The global healthcare spending in autoimmune diseases in 2024 was $215 billion, with a global AI disease therapeutics market opportunity of $396 billion by 2030 [38] - Multi-specific antibodies had annual sales of $12.6 billion in 2024, highlighting an opportunity for best-in-class multi-specific antibodies for autoimmune and inflammatory diseases [38]

Core Insights - Aclaris Therapeutics, Inc. will host its 2025 R&D Day on October 14, 2025, in New York to discuss advancements in immuno-inflammatory disease treatments [1][2] - The event will feature presentations from Aclaris leadership and notable experts in the field, focusing on the company's development of kinase and immune pathway inhibitors [2][6] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel product candidates for immuno-inflammatory diseases, addressing significant therapeutic gaps [8] - The company has a robust R&D engine and a multi-stage portfolio of product candidates aimed at patients with unmet medical needs [8] Event Details - The R&D Day will include a live question and answer session following the formal presentations, with a webcast available for at least 30 days [3] - Presenters include Dr. Zuzana Diamant and Dr. Michael C. Cameron, who will discuss Aclaris' innovative approaches and therapeutic targets [2][4][5] Research and Development Focus - Aclaris is working on uniquely potent small and large molecule product candidates to fill significant gaps in immuno-inflammatory indications [6] - The company aims to "drug the undruggable" by targeting previously inaccessible components of the kinome and multiple pathways [6] - Updates will be provided on Aclaris' ongoing clinical trials and future clinical program designs [6]

Group 1 - Aclaris Therapeutics, Inc. (NASDAQ:ACRS) is considered a fundamentally strong penny stock, with Acadian Asset Management LLC increasing its holdings by 25.9% in Q1, acquiring 451,044 shares to reach a total of 2,195,191 shares, representing a 2.03% ownership stake [1][2] - The company is showing potential for future success despite a history of failures, as it announced that new data from its Phase 2a trial of ATI-2138 for atopic dermatitis will be presented at the 2025 EADV Congress in Paris [2][3] - ATI-2138 is a selective oral covalent inhibitor targeting ITK and JAK3, aimed at treating moderate to severe atopic dermatitis, with effectiveness discussed in a session led by Dr. Jessica Beaziz-Tordjman [3][4] Group 2 - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company based in Pennsylvania, focused on developing novel drug candidates for immune-inflammatory diseases, operating through Therapeutics and Contract Research segments [4]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory conditions, utilizing both small and large molecule discovery engines [2][28] - The company has a strong balance sheet with $181 million, providing a cash runway through the second half of 2028 [2][28] Pipeline and Clinical Assets Clinical Stage Assets 1. **ATI-045 (Bosacitab)** - A TSLP monoclonal antibody currently in Phase 2, actively enrolling in studies for atopic dermatitis [2][3] - Proven biology with a strong safety profile, showing 60 times more potency than Tezspire [17][18] - Anticipated to have a long residence time of 400 hours, significantly longer than competitors [19][20] - Open-label study results indicate rapid efficacy, with notable improvements in atopic dermatitis symptoms [21][22] 2. **ATI-2138** - An ITK/JAK3 covalent inhibitor, also in Phase 2, with positive data reported in July [3][4] - Demonstrates sub-nanomolar potency and unique dual pharmacology, showing significant advantages over competitors like ritlecitinib [5][6] - Phase 2A study in atopic dermatitis showed a 70% mean change in EASI score at week four, with a favorable tolerability profile [10][12] - Next steps include exploring alopecia areata as a potential indication [16] 3. **ATI-052** - A TSLP/IL4R bispecific construct currently enrolling in SAD-MAD work, with data expected towards the end of the year [3][4] Discovery Portfolio - Aclaris has a robust discovery portfolio, including an ITK-selective inhibitor targeting Th2 diseases, which are currently dominated by biologics [4][27] - The company is positioned to address a broad array of unmet needs in immuno-inflammatory markets, particularly in atopic dermatitis and respiratory disorders [4][28] Competitive Landscape - Aclaris has conducted extensive preclinical work to compare its assets against existing treatments, demonstrating superior potency and safety profiles [18][19] - The company is aware of the competitive intensity in the market and aims to leverage its unique capabilities to maintain an edge [4][28] Future Outlook - Aclaris plans to initiate IND for next-generation ITK inhibitors in 2026, focusing on engineering out JAK to improve safety profiles [27] - The company has a catalyst calendar for 2026, with multiple data readouts expected across its assets [28] Key Takeaways - Aclaris Therapeutics is well-positioned in the biopharmaceutical industry with a strong pipeline and financial backing - The company's focus on both small and large molecules allows it to tackle a wide range of immuno-inflammatory conditions - Upcoming clinical trials and data readouts in 2026 are critical for the company's growth and market positioning [28]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biopharmaceutical company focused on developing large and small molecule therapeutics with a strong research operation based in St. Louis [2][4] Key Assets and Development Pipeline - Aclaris is currently working on four assets: 1. A TSLP monoclonal antibody for atopic dermatitis, with top-line data expected in 2026 [3] 2. A bispecific antibody (ATI-52) targeting TSLP and IL4R, with readouts expected by the end of 2025 [3][4] 3. An oral ITKJAK3 small molecule inhibitor (2138) for atopic dermatitis, moving into alopecia areata later this year [4] 4. A next-generation ITK program expected to enter IND in 2026 [4] Bispecific Antibody Development - ATI-52 targets both IL-4 and IL-13, aiming for a broader therapeutic response across respiratory and dermatological indications [5][6] - The bispecific is designed for high affinity and long residence time (up to 400 hours) against both targets [7][8] - Preclinical work shows independent saturation of binding sites, enhancing the potential for success [9][10] Clinical Trials and Data - The Phase 1 SAD and MAD trials for ATI-52 are expected to report safety, tolerability, and pharmacokinetics data by the end of the year [13][14] - The ongoing Phase 2a trial for ADI-45 showed a 94% response rate in EASI-75, with significant activity observed even after treatment cessation [21][22] - Aclaris is implementing rigorous patient selection criteria to manage placebo response rates in clinical trials [36][38] Competitive Landscape - Aclaris believes that its TSLP antibody (ADI-45) has a competitive edge over existing therapies due to its potency and long residence time [20][28] - The company is aware of the crowded TSLP space but is confident in the differentiation of its products based on clinical data [19][28] Financial Position and Future Plans - Aclaris has approximately $181 million in cash, expected to last until mid-2028, allowing for the completion of key trials [62] - The company is exploring non-dilutive financing options, including monetizing royalty streams from partnerships [63][64] Long-term Strategy - Aclaris is considering partnerships for its respiratory indications while maintaining a focus on atopic dermatitis as a key area for growth [51][52] - The next-generation ITK compounds are expected to enter clinical trials in 2026, with improved potency and selectivity [59][61] Conclusion - Aclaris Therapeutics is positioned to leverage its innovative pipeline and strong clinical data to capture market opportunities in the biopharmaceutical space, particularly in dermatological and respiratory indications [2][4][62]

Core Insights - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [3] Group 1: Upcoming Events - Aclaris will participate in two healthcare conferences in September 2025 [1] - The first event is a fireside chat at the Cantor Global Healthcare Conference on September 3, 2025, at 1:00 PM EDT [4] - The second event is a corporate presentation at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 9:00 AM EDT [4] Group 2: Webcast Information - Live and archived webcasts of both events will be accessible on Aclaris' website for at least 30 days [2]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported a **$15.4 million** net loss in Q2 2025, with total assets decreasing to **$189.1 million** due to operational cash usage [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $25,402 | $24,570 | | Marketable securities (Short-term & Long-term) | $155,488 | $179,326 | | Total current assets | $104,202 | $125,951 | | **Total assets** | **$189,147** | **$220,327** | | **Liabilities & Equity** | | | | Total current liabilities | $26,839 | $31,596 | | Total liabilities | $57,408 | $64,773 | | Accumulated deficit | $(933,375) | $(902,861) | | **Total stockholders' equity** | **$131,739** | **$155,554** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | 6 Months 2025 | 6 Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,777 | $2,766 | $3,232 | $5,163 | | Research and development | $11,449 | $8,759 | $23,033 | $18,604 | | General and administrative | $5,386 | $4,752 | $11,525 | $11,596 | | Loss from operations | $(18,408) | $(12,854) | $(36,492) | $(31,786) | | **Net loss** | **$(15,429)** | **$(10,986)** | **$(30,514)** | **$(27,927)** | | Net loss per share | $(0.13) | $(0.15) | $(0.25) | $(0.39) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(23,050) | $(33,137) | | Net cash provided by investing activities | $24,166 | $16,159 | | Net cash used in financing activities | $(284) | $(66) | | **Net increase (decrease) in cash** | **$832** | **$(17,044)** | | Cash and cash equivalents at end of period | $25,402 | $22,834 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical firm focused on immuno-inflammatory diseases, utilizing its proprietary KINect drug discovery platform[19](index=19&type=chunk) - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of **$180.9 million** and an accumulated deficit of **$933.4 million**. Management believes existing cash is sufficient to fund operations for more than 12 months[20](index=20&type=chunk)[22](index=22&type=chunk) - The fair value of the contingent consideration liability related to the Confluence acquisition increased by **$1.8 million** during the first six months of 2025, primarily due to changes in the probability of success for certain product candidates and lower discount rates[43](index=43&type=chunk)[81](index=81&type=chunk) - In June 2025, stockholders approved an increase in authorized common stock from **200 million** to **400 million** shares[50](index=50&type=chunk) - The company has two reportable segments: therapeutics, which focuses on developing innovative therapies, and contract research, which provides laboratory services[89](index=89&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Advancing key product candidates, the company saw R&D expenses rise to **$23.0 million** in H1 2025, with **$180.9 million** in liquidity [Our Key Product Candidates](index=32&type=section&id=Our%20Key%20Product%20Candidates) - **Bosakitug (ATI-045):** An anti-TSLP monoclonal antibody. A Phase 2 trial in moderate to severe atopic dermatitis was initiated in June 2025, with top-line data expected in the second half of 2026[100](index=100&type=chunk)[103](index=103&type=chunk) - **ATI-2138:** An oral ITK/JAK3 inhibitor. Announced positive top-line results from a Phase 2a trial in atopic dermatitis in July 2025. The company intends to further develop it for alopecia areata[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - **ATI-052:** An anti-TSLP and anti-IL-4R bispecific antibody. An IND was cleared in April 2025, and a Phase 1a/1b program was initiated in June 2025. Top-line data from the Phase 1a portion is expected in early 2026[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - **Lepzacitinib (ATI-1777):** A topical "soft" JAK 1/3 inhibitor. The company is seeking a global development and commercialization partner for this program following positive Phase 2b results[111](index=111&type=chunk)[113](index=113&type=chunk) [Results of Operations](index=49&type=section&id=Results%20of%20Operations) - Total revenue decreased by **$1.0 million** for Q2 2025 and **$1.9 million** for the six months ended June 30, 2025, compared to the same periods in 2024. The decline was primarily due to lower licensing revenue following the sale of a portion of OLUMIANT® royalty payments[159](index=159&type=chunk)[161](index=161&type=chunk) Research & Development Expenses by Program (in thousands) | Program | 6 Months 2025 | 6 Months 2024 | Change | | :--- | :--- | :--- | :--- | | Bosakitug | $6,231 | $0 | $6,231 | | ATI-2138 | $2,926 | $815 | $2,111 | | ATI-052 | $2,037 | $0 | $2,037 | | Zunsemetinib | $216 | $4,514 | $(4,298) | | Lepzacitinib | $0 | $1,368 | $(1,368) | | **Total R&D Expenses** | **$23,033** | **$18,604** | **$4,429** | - The increase in R&D expenses for the six months ended June 30, 2025 was driven by manufacturing and clinical development costs for Bosakitug, ATI-2138, and ATI-052, offset by decreased spending on Zunsemetinib and Lepzacitinib[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[168](index=168&type=chunk) [Liquidity and Capital Resources](index=52&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$180.9 million** in cash, cash equivalents, and marketable securities[179](index=179&type=chunk) - Net cash used in operating activities decreased to **$23.1 million** for the first six months of 2025, compared to **$33.1 million** for the same period in 2024, primarily due to a decrease in cash used for accounts payable and accrued expenses[182](index=182&type=chunk)[183](index=183&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities are sufficient to fund operating and capital expenditure requirements for more than 12 months from the issuance date of this report[189](index=189&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=59&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Aclaris Therapeutics is not required to provide this information - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[201](index=201&type=chunk) [Item 4. Controls and Procedures](index=59&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2025, with no material changes to internal controls - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[202](index=202&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[203](index=203&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings or aware of any threatened actions - The company is not currently a party to any material legal proceedings[204](index=204&type=chunk) [Item 1A. Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the company's risk factors from those described in its Annual Report on Form 10-K - The company's risk factors have not changed materially from those described in its Annual Report[205](index=205&type=chunk) [Item 5. Other Information](index=61&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 trading arrangements during Q2 2025 - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[207](index=207&type=chunk) [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including certificates of incorporation and officer certifications

Group 1: Financial Performance - Aclaris Therapeutics reported a quarterly loss of $0.13 per share, which is in line with the Zacks Consensus Estimate and an improvement from a loss of $0.15 per share a year ago [1] - The company posted revenues of $1.78 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 14.42%, but down from $2.77 million year-over-year [2] - Aclaris has exceeded consensus EPS estimates two times over the last four quarters [1][2] Group 2: Stock Performance and Outlook - Aclaris shares have declined approximately 37.5% since the beginning of the year, contrasting with the S&P 500's gain of 7.9% [3] - The company's earnings outlook is crucial for assessing future stock performance, with current consensus EPS estimates at -$0.14 for the coming quarter and -$0.54 for the current fiscal year [4][7] - The estimate revisions trend for Aclaris was unfavorable prior to the earnings release, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Group 3: Industry Context - The Medical - Drugs industry, to which Aclaris belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Aclaris's stock performance [5]