WAYNE, Pa., Nov. 25, 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 Dr. Neal Walker, Aclaris’ Chief Executive Officer and other members of Aclaris’ senior leadership team will participate in a fireside chat during the Piper Sandler 37th Annual Healthcare Conference in New York City. The discussion will take place on Tuesday December 2, 2025 at ...

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on large and small molecule therapeutics with three clinical-stage assets and one preclinical-stage asset expected to enter IND in 2026 [4][30] Key Clinical Assets 1. **2138**: An oral small molecule inhibitor of ITK and JAK3, recently reported positive top-line data in atopic dermatitis (AD) [4] - Plans to move to indications in lichen planus or scarring alopecia in 2026 [4] 2. **045**: A best-in-class TSLP monoclonal antibody currently in a Phase 2 study for moderate to severe atopic dermatitis [4][7] - Demonstrated a resonance time binding to TSLP for over 400 hours, significantly longer than competitors [7] - Phase 2A results showed 94% of subjects had EASI75 response and 88% had IGA0/1 [7] 3. **Bispecific Antibody**: Combines TSLP with IL4R, undergoing SAD/MAD studies with data expected in early 2026 [5][18] - Expected to show greater potency than existing treatments like Dupixent and Tezspire [19] 4. **Next-Gen ITK Inhibitor**: Engineered to remove the JAK3 component, targeting TH2 and TH1 diseases, with IND expected in the second half of 2026 [5][30] Clinical Development Strategy - Aclaris is focusing on a dual review process in clinical trials to ensure accurate patient enrollment and data integrity [11][12] - The company is strategically positioning its assets to address unmet medical needs in both dermatological and respiratory indications [19][39] Market Opportunities - **Atopic Dermatitis**: High unmet need with existing treatments showing limited efficacy in a significant portion of patients [19] - **Lichen Planus and Scarring Alopecia**: No approved treatments currently exist, presenting a significant market opportunity [39] - Lichen planus has a prevalence of about 1%, while scarring alopecia is considered orphan with around 50,000 patients [41] Financial Position - Aclaris has approximately $170 million on its balance sheet, providing a runway into Q3 2028 [43] - The company maintains a burn rate of $10-$13 million per quarter, indicating efficient capital management [43] Upcoming Milestones - Multiple data readouts expected in 2026, including: - Phase 2 data for TSLP MAB and bispecific antibody studies [20][43] - IND submission for next-gen ITK inhibitor [43] Conclusion - Aclaris Therapeutics is well-positioned with a diverse pipeline targeting significant unmet medical needs in dermatology and respiratory diseases, supported by a strong financial position and strategic clinical development plans [43][44]

Aclaris Therapeutics Conference Call Summary Company Overview - Aclaris Therapeutics is a clinical stage biotech company with three assets in the clinic and another in development, supported by a robust R&D group focused on both new asset discovery and preclinical sciences [1][2] - The company has expertise in kinase inhibition, with a history stemming from Pfizer, and has expanded its portfolio through acquisitions, including a deal with BioShen [2][3] Key Assets and Pipeline - Aclaris is developing both small and large molecule platforms targeting important unmet medical needs [1][2] - The acquisition of BioShen's assets has allowed Aclaris to explore both dermatological and immunological indications, particularly in respiratory and gastrointestinal areas [3] Bosakitug (TSLP Antibody) - Bosakitug is a TSLP antibody in phase two trials, noted for its potency, being 70 times more potent than Tezopelumab [5][9] - It has a long residence time of 400 hours on TSLP compared to 3-20 hours for competitors, which enhances its therapeutic potential [7] - Phase 2A results showed a 94% EASI75 response and an 88% IGA01 response in atopic dermatitis, with sustained effects observed 12 weeks post-treatment [8][12] Phase 2B Study - Aclaris is confident in the phase 2B study due to the robust data from phase 2A, focusing on a well-defined patient population to minimize placebo effects [11][12] - The dosing regimen remains consistent with phase 2A, aiming for a competitive response rate compared to existing treatments [15] Future Directions - Aclaris plans to explore the potential of Bosakitug in both dermatological and respiratory indications, with a focus on dermatology for the current asset [19] - The company is also developing a bispecific antibody (052) targeting TSLP and IL-4R, which has shown promising preclinical results [20][21] ITK Platform and 2138 - 2138 is the lead compound in Aclaris's ITK franchise, demonstrating dual pharmacology by inhibiting ITK and JAK3, with a focus on atopic dermatitis and potential expansion into lichen planus [31][36] - The compound has shown significant potency and a favorable safety profile, with plans to move into clinical trials for lichen planus due to its mechanistic fit and unmet medical need [36][38] Financial Position and Future Outlook - Aclaris has a strong cash position that extends its runway into the second half of 2028, allowing for continued development of its pipeline without immediate capital raises [42] - The company anticipates multiple data readouts and milestones in 2026, which could significantly impact investor interest and market positioning [41][42] Conclusion - Aclaris Therapeutics is positioned for significant growth with a diverse pipeline targeting critical areas in dermatology and immunology, backed by a solid financial foundation and promising clinical data [41][42]

Aclaris Therapeutics FY Conference Summary Company Overview - Aclaris Therapeutics is a development-stage biotech company focused on large and small molecule therapeutics for immunoinflammatory diseases [3][4] - The company has a strong drug discovery platform developed by former Pfizer employees and a multidisciplinary team experienced in drug development [3] Key Products and Pipeline - **2138**: An oral ITK JAK3 inhibitor, currently in clinical development for atopic dermatitis (AD) [3][6] - **TSLP MAB and TSLP IL4R bispecific construct**: In-licensed biologics from BiOcean, currently in clinical trials [3][4][5] - Aclaris is focusing on atopic dermatitis due to the mechanism of action and competitive landscape [6][7] Clinical Development and Data - The company is actively enrolling patients for the TSLP MAB study in atopic dermatitis, with data expected in the second half of 2026 [7][8] - Aclaris believes their TSLP MAB is 70 times more potent than competitors like Tezspire, which enhances their confidence in achieving positive outcomes [9][10] - Previous studies showed high efficacy with EASI 75 scores of 94% and 88% on IgA, indicating strong potential for their treatments [10] Market Position and Strategy - Aclaris is strategically targeting less competitive indications like atopic dermatitis, while also considering high unmet need areas such as lichen planus and scarring alopecia [14][15] - The company is aware of the competitive intensity in the respiratory indications and has opted to focus on atopic dermatitis for their TSLP MAB [6][7] Future Catalysts - Key upcoming milestones include: - Reporting SAD and MAD data by the end of 2026 - Initiating two Phase 1B studies in moderate to severe asthma and atopic dermatitis [52] - Advancing next-gen ITK into the clinic in the second half of 2026 [52] - The company has a strong cash position of over $167 million, providing a runway until Q3 of 2028 [57] Competitive Landscape - Aclaris acknowledges competition in the ITK space but believes their product's potency and broader applicability will differentiate them [25][30] - The company is monitoring competitor data closely and remains optimistic about their own development trajectory [25][30] Challenges and Considerations - The rising placebo rates in clinical trials pose a challenge, with Aclaris emphasizing the importance of rigorous patient selection to ensure valid results [41][42] - The company is aware of the complexities in dermatology trials and is implementing measures to mitigate variability in patient responses [40][41] Conclusion - Aclaris Therapeutics is positioned for a busy and potentially transformative 2026, with multiple catalysts on the horizon and a focus on innovative treatments for immunoinflammatory diseases [58][59]

Financial Performance - The net loss for the nine months ended September 30, 2025, was $45.1 million, and for the year ended December 31, 2024, it was $132.1 million, with an accumulated deficit of $948.0 million as of September 30, 2025[123]. - The net loss for the three months ended September 30, 2025, was $7,586,000, compared to a net loss of $9,615,000 in the same period of 2024[162]. - Total revenue for the three months ended September 30, 2025, was $3,299,000, a decrease of 24.1% compared to $4,346,000 in the same period of 2024[162]. - Contract research revenue decreased by $160,000 (24.8%) for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to lower overall hours billed for laboratory services[165]. - Licensing revenue decreased by $887,000 (24.0%) for the three months ended September 30, 2025, mainly due to a larger milestone achieved under the Sun Pharma license agreement in the prior year[166]. - Research and development expenses increased by $7,072,000 (118.7%) for the three months ended September 30, 2025, totaling $13,028,000 compared to $5,956,000 in 2024[169]. - The company has incurred significant costs associated with operating as a public company and will need substantial additional funding to support ongoing operations[124]. - The company anticipates incurring net losses in the near term as it continues the development of product candidates and may not generate revenue if clinical trials are unsuccessful or if FDA approvals are delayed[193]. Clinical Trials and Product 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[106]. - In July 2025, ATI-2138 Phase 2a trial results showed a mean improvement in EASI score of 61% at week 12, with 63% of patients experiencing a clinically meaningful response[111]. - The company initiated a Phase 2 trial for bosakitug in June 2025, expecting to announce top-line data in the second half of 2026[108]. - The company plans to initiate Phase 1b proof-of-concept trials for ATI-052 in asthma and atopic dermatitis in the first half of 2026, with results expected in the second half of 2026[115]. - The Phase 2 trial for ATI-2138 enrolled 14 patients, with 12 completing treatment, indicating a strong safety and tolerability profile[111]. - The company is developing next-generation covalent ITK selective inhibitors and expects to file an IND application in the second half of 2026[116]. Agreements and Financial Obligations - The exclusive license agreement with Biosion includes a total of $30.0 million in upfront cash consideration and warrants to purchase 14,281,985 shares of common stock[127]. - 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[128]. - 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[131]. - The company recognized $2.5 million of non-cash royalty income during the nine months ended September 30, 2025[132]. - An exclusive patent license agreement with Sun Pharma was established, which includes a mid single-digit tiered royalty based on Sun Pharma's net sales[133]. - The company recognized $1.5 million of licensing revenue during the nine months ended September 30, 2025, a portion of which was payable to third parties[134]. - The company agreed to pay up to $75 million in contingent consideration based on specified regulatory and commercial milestones under the Confluence Agreement[141]. - The company recorded a charge of $1.9 million to the contingent consideration liability during the nine months ended September 30, 2025, primarily due to changes in the probability of success for certain product candidates[161]. - The balance of the contingent consideration liability related to the Confluence Agreement was $10.6 million as of September 30, 2025[201]. Cash Flow and Financing - Cash and cash equivalents as of September 30, 2025, were $25.3 million, an increase from $24.6 million as of December 31, 2024[188]. - The company had cash, cash equivalents, and marketable securities totaling $167.2 million as of September 30, 2025[186]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $33,982,000, compared to $11,137,000 in the same period of 2024[189]. - Net cash provided by investing activities increased to $37,996,000 for the nine months ended September 30, 2025, compared to $18,954,000 in the same period of 2024, primarily due to lower purchases of marketable securities and higher proceeds from sales and maturities of marketable securities[191]. - Net cash used in financing activities rose to $3,328,000 for the nine months ended September 30, 2025, compared to $44,000 in the same period of 2024, mainly due to the payment of deferred transaction consideration related to the Biosion Agreement[192]. - The company may engage in additional equity and other financing transactions to raise funds, as it has incurred net losses and negative cash flows from operations since inception[185]. - The company may raise additional capital through the sale of equity or debt securities, which could dilute stockholder ownership[197]. Economic and Operational Considerations - Macroeconomic conditions, including inflation and geopolitical conflicts, may negatively affect the company's growth and results of operations[125]. - Future funding requirements will depend on the resources needed to support the development of product candidates and may be affected by global economic conditions[196]. - The company operates two reportable segments: therapeutics, focused on immuno-inflammatory diseases, and contract research, which earns revenue from laboratory services[204]. - As of September 30, 2025, the company had an aggregate remaining lease payment obligation of $2.7 million for its headquarters and laboratory spaces[200]. - The discount rate applied to potential payments ranged between 6.8% and 8.4% depending on the year of each potential payment as of September 30, 2025[160]. - Probability of success assumptions for regulatory milestones ranged between 21% and 40% as of September 30, 2025[160]. - The company has entered into contracts with CROs and other service providers for clinical trials and manufacturing, which generally allow for termination upon notice, indicating non-cancelable obligations are not material[203].

Core Insights - Aclaris Therapeutics reported a quarterly loss of $0.12 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.13, representing an earnings surprise of +7.69% [1] - The company generated revenues of $3.3 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 107.75%, although this is a decline from $4.35 million in the same quarter last year [2] - Aclaris shares have underperformed, losing about 8.9% since the beginning of the year, compared to a 15.6% gain in the S&P 500 [3] Financial Performance - Over the last four quarters, Aclaris has surpassed consensus EPS estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.14 on revenues of $1.57 million, and for the current fiscal year, it is -$0.51 on revenues of $6.39 million [7] Industry Context - The Medical - Drugs industry, to which Aclaris belongs, is currently ranked in the top 39% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Aclaris' stock performance [5][6]

Financial Performance - Aclaris reported a net loss of $14.6 million for Q3 2025, compared to a net loss of $7.6 million in Q3 2024, and a total net loss of $45.1 million for the nine months ended September 30, 2025, compared to $35.5 million for the same period in 2024[9]. - Total revenue for Q3 2025 was $3.3 million, down from $4.3 million in Q3 2024, and $6.5 million for the nine months ended September 30, 2025, compared to $9.5 million for the same period in 2024[10]. - Total revenue for Q3 2025 was $3,299,000, a decrease of 24% compared to $4,346,000 in Q3 2024[17]. - Licensing revenue decreased to $2,814,000 in Q3 2025 from $3,701,000 in Q3 2024, representing a decline of 24%[17]. - The net loss for Q3 2025 was $14,614,000, compared to a net loss of $7,586,000 in Q3 2024, reflecting an increase in losses of 93%[17]. - Total costs and expenses for Q3 2025 were $20,448,000, an increase from $14,817,000 in Q3 2024, representing a 38% increase[17]. Research and Development - Research and development (R&D) expenses increased to $13.0 million for Q3 2025 from $6.0 million in Q3 2024, and $36.1 million for the nine months ended September 30, 2025, compared to $24.6 million for the same period in 2024[11]. - Research and development expenses increased significantly to $13,028,000 in Q3 2025, up from $5,956,000 in Q3 2024, marking a 119% increase[17]. - Aclaris expects to initiate a Phase 2 trial of ATI-2138 in an additional indication in the first half of 2026, following positive results from the Phase 2a trial[3]. - The Phase 2a trial of ATI-2138 showed a 77% decrease in Eczema Area and Severity Index (EASI) score at week 4 (p<0.001) and a 64% decrease in Body Surface Area (BSA) score (p<0.001)[7]. - Top line results from the Phase 1a/1b program of investigational bispecific antibody ATI-052 are expected in early 2026, with Phase 1b trials in asthma and atopic dermatitis anticipated to start in the first half of 2026[7]. - Aclaris aims to provide top line results from the Phase 2 trial of investigational anti-TSLP monoclonal antibody Bosakitug in the second half of 2026, with patient enrollment ongoing[7]. - The company plans to file an initial Investigational New Drug (IND) application for a next-generation JAK-sparing ITK inhibitor in the second half of 2026[7]. Cash and Assets - Aclaris has a cash runway of $167.2 million as of September 30, 2025, sufficient to fund operations into the second half of 2028[8]. - Cash, cash equivalents, and marketable securities decreased to $167,209,000 as of September 30, 2025, down from $203,896,000 at the end of 2024[19]. - Total assets decreased to $175,534,000 as of September 30, 2025, compared to $220,327,000 at the end of 2024[19]. - Total stockholders' equity decreased to $120,100,000 as of September 30, 2025, down from $155,554,000 at the end of 2024[19]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $33,982,000, compared to $11,137,000 for the same period in 2024[21]. - Stock-based compensation expense for the nine months ended September 30, 2025, was $9,458,000, an increase from $7,996,000 in the same period of 2024[21]. - The company is exploring non-dilutive opportunities to extend its cash runway further[8].

Core Insights - Aclaris Therapeutics reported positive results from the Phase 2a trial of its ITK/JAK3 inhibitor ATI-2138, confirming ITK as a therapeutic target and planning to initiate a Phase 2 trial in additional indications in the first half of 2026 [1][3] - The company has a strong cash runway expected to fund operations into the second half of 2028, with potential for further non-dilutive financing opportunities [2][10] - Aclaris is advancing a diversified pipeline targeting immuno-inflammatory disorders, with significant clinical milestones anticipated throughout 2026 and 2027 [2][3] Pipeline Developments - The Phase 2a trial of ATI-2138 achieved primary and key secondary endpoints, showing a 77% decrease in Eczema Area and Severity Index (EASI) score and a 64% reduction in Body Surface Area (BSA) score at week 4 [3] - Aclaris plans to file an Investigational New Drug (IND) application for a next-generation JAK-sparing ITK inhibitor in the second half of 2026 [3] - The company expects to initiate Phase 1b proof-of-concept trials for ATI-052 in asthma and atopic dermatitis in the first half of 2026 [1][10] Financial Performance - As of September 30, 2025, Aclaris had cash, cash equivalents, and marketable securities totaling $167.2 million, down from $203.9 million at the end of 2024 [6][20] - The net loss for the third quarter of 2025 was $14.6 million, compared to $7.6 million for the same period in 2024, with a total revenue of $3.3 million, down from $4.3 million year-over-year [7][8] - Research and development expenses increased to $13.0 million for the third quarter of 2025, driven by costs associated with clinical development and product candidate manufacturing [9][11]

Core Insights - Aclaris Therapeutics, Inc. will participate in three healthcare conferences in November 2025, showcasing its focus on immuno-inflammatory diseases [1][4]. Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel product candidates for patients with immuno-inflammatory diseases who currently lack satisfactory treatment options [3]. - The company has a multi-stage portfolio of product candidates supported by a robust research and development engine [3]. Upcoming Events - On November 12, 2025, at 11:00 AM EST, Aclaris' CEO Dr. Neal Walker and senior leadership will participate in a fireside chat at the Guggenheim 2 Annual Healthcare Conference in Boston, MA [4]. - On the same day at 1:20 PM EST, Aclaris' President and COO Dr. Hugh Davis will also participate in a fireside chat at the Stifel 2025 Healthcare Conference in New York, NY [4]. - On November 17, 2025, at 2:00 PM GMT (9:00 AM EST), Dr. Walker will engage in a fireside chat at the Jefferies Global Healthcare Conference in London, UK [4].

Core Insights - Momentum investing focuses on following a stock's recent price trends, with the aim of buying high and selling higher, capitalizing on established price movements [1] - Aclaris Therapeutics (ACRS) currently holds a Momentum Style Score of B, indicating a favorable momentum characteristic [2] - The Zacks Rank for ACRS is 2 (Buy), suggesting strong potential for outperformance in the market [3] Price Performance - ACRS shares have increased by 1.6% over the past week, while the Zacks Medical - Drugs industry remained flat during the same period [5] - Over the past month, ACRS has shown a price change of 4.15%, significantly outperforming the industry's 0.45% [5] - In the last quarter, ACRS shares rose by 19.64%, and over the past year, they gained 66.12%, compared to the S&P 500's increases of 7.28% and 16.15%, respectively [6] Trading Volume - ACRS has an average 20-day trading volume of 1,004,293 shares, which serves as a bullish indicator when combined with rising stock prices [7] Earnings Outlook - In the past two months, one earnings estimate for ACRS has increased, while none have decreased, leading to a consensus estimate improvement from -$0.52 to -$0.51 [9] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating positive earnings momentum [9] Conclusion - Aclaris Therapeutics is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for investors seeking short-term gains [11]