Aclaris Therapeutics(ACRS) - 2025 Q2 - Quarterly Results

Executive Summary & Company Overview Introduction and Key Highlights 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][2][3] - Advanced Bosakitug (ATI-045) into Phase 2 trial in Atopic Dermatitis (AD), with patient dosing underway[1][3][4] - Initiated dosing in Phase 1a/1b clinical program for ATI-052[1][5] - Strong cash runway expected to fund operations into H2 2028, with exploration of additional non-dilutive opportunities[1][2][7] Pipeline Updates ATI-2138 (ITK/JAK3 Inhibitor) Phase 2a Trial Results 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] - Trial confirmed favorable tolerability profile and demonstrated clinically meaningful improvements in disease severity for moderate-to-severe AD patients[3] - 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] Bosakitug (ATI-045) Anti-TSLP Monoclonal Antibody Phase 2 Trial 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] - The global Phase 2 trial will evaluate bosakitug in approximately 90 patients with moderate-to-severe AD[4] - Top-line results for the Bosakitug Phase 2 trial are expected in H2 2026[4] ATI-052 Anti-TSLP/IL-4R Bispecific Antibody Phase 1a/1b Program 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] - 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] - 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] Corporate Updates Liquidity and Capital Resources 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][7][11] - Aclaris is assessing potential non-dilutive opportunities to extend the cash runway further[2][11] Senior Leadership Update 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] - Joe Monahan, Ph.D. will remain as Special Scientific Advisor to the CEO through Q1 2026 as part of his planned retirement[11] Financial Performance Second Quarter and Year-to-Date 2025 Financial Summary 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 | 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] Total Revenue | 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] Research and Development (R&D) Expenses | 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] - For the six-month period, clinical development expenses for ATI-2138 also contributed to the increase, partially offset by reduced zunsemetinib development expenses[10] General and Administrative (G&A) Expenses | 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] - YTD 2025 G&A expenses decreased primarily due to lower personnel expenses resulting from lower termination benefits[12] Revaluation of Contingent Consideration | 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] - 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] Condensed Consolidated Statements of Operations 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 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 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] About Aclaris Therapeutics, Inc. Company Overview 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] - The company develops novel product candidates for immuno-inflammatory diseases where patients lack satisfactory treatment options[14] - Aclaris has a multi-stage portfolio of product candidates supported by a robust R&D engine[14] Cautionary Note Regarding Forward-Looking Statements Forward-Looking Statements Disclaimer 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] - Risks include uncertainties in clinical trials, reliance on third parties, ability to form partnerships, macroeconomic environment, and other risks detailed in SEC filings[15] - Aclaris assumes no obligation to update any forward-looking statements[15] Aclaris Therapeutics Contacts Investor and Media Relations 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]