WAYNE, Pa., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the Company will participate in two upcoming healthcare conferences in September. On Wednesday September 3, 2025, at 1:00 PM EDT, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the ...

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]

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].

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, 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]