Aclaris Therapeutics(ACRS)

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Aclaris Therapeutics to Participate in the HC Wainwright “HCW@Home” Series
GlobeNewswire· 2025-05-09 11:00
WAYNE, Pa., May 09, 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 Aclaris’ Chief Executive Officer Neal Walker and other members of the Aclaris senior leadership team will participate in a fireside chat during the virtual HC Wainwright “HCW@Home” series. The virtual fireside chat will take place on Friday May 16, 2025, at 1:00 PM EDT. A live a ...
Aclaris Therapeutics(ACRS) - 2025 Q1 - Quarterly Report
2025-05-08 20:30
Financial Performance - The company reported a net loss of $15.1 million for the three months ended March 31, 2025, and a net loss of $132.1 million for the year ended December 31, 2024, with an accumulated deficit of $917.9 million as of March 31, 2025[121]. - Total revenue for the three months ended March 31, 2025, was $1.455 million, a decrease of 39.2% from $2.398 million in the same period of 2024[160]. - Contract research revenue decreased to $0.445 million in Q1 2025 from $0.657 million in Q1 2024, driven by lower overall hours billed[161]. - Licensing revenue fell to $1.010 million in Q1 2025 from $1.741 million in Q1 2024, primarily due to lower royalties following the sale of a portion of OLUMIANT® royalty payments[162]. - The net loss for the three months ended March 31, 2025, was $15.085 million, an improvement from a net loss of $16.941 million in the same period of 2024[160]. - Cash and cash equivalents increased to $30.3 million as of March 31, 2025, compared to $24.6 million as of December 31, 2024[178]. - The company had cash, cash equivalents, and marketable securities totaling $190.5 million as of March 31, 2025[176]. - Net cash used in operating activities decreased to $13.057 million in Q1 2025 from $20.815 million in Q1 2024, primarily due to a decrease in cash used for accounts payable[180]. - The company anticipates incurring net losses in the near term as it continues the development of its product candidates[183]. - The company believes its existing cash and marketable securities are sufficient to fund operations for more than 12 months from the date of the financial statements[186]. - The company has a contingent consideration liability balance of $9.0 million as of March 31, 2025, related to the Confluence Agreement[192]. - The aggregate remaining lease payment obligation for two spaces is $3.1 million as of March 31, 2025[191]. Research and 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[100]. - The company plans to initiate a Phase 2 trial for bosakitug in approximately 90 patients with moderate to severe atopic dermatitis in Q2 2025[101]. - ATI-2138 was well tolerated in a Phase 1 trial with 60 healthy volunteers, showing dose-dependent inhibition of ITK and JAK3 biomarkers, with no serious adverse events reported[104]. - The Phase 2a trial for ATI-2138 has been completed, and top-line data is expected to be announced in June 2025[105]. - Lepzacitinib met its primary efficacy endpoint in a Phase 2b trial, showing a 69.7% improvement in EASI score at week 4 compared to 58.7% in the vehicle group (p=0.035)[111]. - The company discontinued the development of zunsemetinib for immuno-inflammatory diseases in 2023 following Phase 2 trial results[139]. Partnerships and Agreements - The company entered into an exclusive license agreement with Biosion in November 2024, paying $30.0 million in upfront cash and issuing warrants for 14,281,985 shares of common stock[124][125]. - 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[126]. - 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[129]. - The company entered into a license agreement with Sun Pharmaceutical Industries, which includes mid single-digit tiered royalties based on net sales of deuruxolitinib[131]. - The company recognized $1.0 million of licensing revenue during the three months ended March 31, 2025, all payable to third parties[134]. - The company agreed to pay up to $75 million in contingent consideration based on regulatory and commercial milestones under the Confluence Agreement[138]. Operational Challenges - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances its product candidates through development[121]. - Macroeconomic conditions, including inflation and geopolitical conflicts, may negatively impact the company's growth and results of operations[123]. - The probability of achieving regulatory milestones ranges between 17% and 40% as of March 31, 2025[158]. - The company recorded a charge of $0.3 million to the contingent consideration liability during the three months ended March 31, 2025, primarily due to the passage of time[159]. Workforce and Organizational Changes - The company approved a workforce reduction of approximately 46% in December 2023, with severance payments of $0.2 million made during the three months ended March 31, 2025[140]. Business Segments - The therapeutics segment focuses on developing innovative therapies for immuno-inflammatory diseases, while the contract research segment generates revenue from laboratory services[195].
Aclaris Therapeutics (ACRS) Reports Q1 Loss, Misses Revenue Estimates
ZACKS· 2025-05-08 13:00
Aclaris Therapeutics (ACRS) came out with a quarterly loss of $0.12 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.24 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 29.41%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.32 per share when it actually produced a loss of $0.10, delivering a surprise of 68.75%.Over the last four quar ...
Aclaris Therapeutics(ACRS) - 2025 Q1 - Quarterly Results
2025-05-08 11:15
Financial Performance - Aclaris reported a net loss of $15.1 million for Q1 2025, a decrease from a net loss of $16.9 million in Q1 2024[14] - Total revenue for Q1 2025 was $1.5 million, down from $2.4 million in Q1 2024, primarily due to reduced royalty payments[14] - Net loss for Q1 2025 was $15,085,000, an improvement from a net loss of $16,941,000 in Q1 2024[26] - Depreciation and amortization expenses decreased to $128,000 from $243,000 year-over-year[26] - Stock-based compensation expense increased to $3,535,000 compared to $2,089,000 in the previous year[26] - Revaluation of contingent consideration was $300,000, down from $2,800,000 in the prior year[26] - Changes in operating assets and liabilities resulted in a cash outflow of $1,935,000, an improvement from $9,006,000 in Q1 2024[26] - Net cash used in operating activities was $13,057,000, compared to $20,815,000 in the same quarter last year[26] Cash Position and Runway - Aclaris ended Q1 2025 with $190.5 million in cash, cash equivalents, and marketable securities, down from $203.9 million at the end of 2024[13] - The expected cash runway has been extended through the first half of 2028, fully funding preclinical and clinical development plans[9] Research and Development - Research and development expenses increased to $11.6 million in Q1 2025 from $9.8 million in the prior year, driven by costs associated with the bosakitug program[15] - Aclaris plans to initiate a Phase 2 trial for bosakitug in atopic dermatitis with approximately 90 patients in Q2 2025[3] - Top line results from the Phase 2a trial of ATI-2138 in atopic dermatitis are expected in June 2025[6] - The IND application for ATI-052 was cleared by the FDA, with plans to initiate a Phase 1 trial in Q2 2025[7] - Aclaris is exploring partnerships for the global development of bosakitug in respiratory indications[10] - The company aims to develop next-generation ITK inhibitors and bispecific antibodies targeting cytokine pathways, with new IND submissions expected starting in 2026[11]
Aclaris Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2025-05-08 10:50
Core Insights - Aclaris Therapeutics is entering a transformative multi-year period with significant milestones expected in 2025 and 2026, focusing on immuno-inflammatory diseases [2] - The company has extended its expected cash runway through the first half of 2028, allowing for continued execution of its clinical programs [2][11] - Aclaris has received positive Phase 2 results from its Chinese partner CTTQ, indicating enhanced potency of its investigational drug bosakitug (ATI-045) [3][5] - The U.S. FDA has cleared the Investigational New Drug (IND) application for ATI-052, a bispecific antibody, paving the way for its clinical trials [7] Pipeline Developments - Bosakitug (ATI-045) is an investigational anti-TSLP monoclonal antibody, with plans to initiate a placebo-controlled Phase 2 trial in atopic dermatitis (AD) in Q2 2025 [5] - ATI-2138, an oral ITK/JAK3 inhibitor, is also set for new clinical trials, with top-line results from a Phase 2a trial in AD expected in June 2025 [6] - Aclaris intends to seek partnerships for the global development of bosakitug in respiratory indications, while maintaining focus on dermatological applications [5] Financial Performance - For Q1 2025, Aclaris reported a net loss of $15.1 million, an improvement from a loss of $16.9 million in Q1 2024 [12] - Total revenue for Q1 2025 was $1.5 million, down from $2.4 million in the same period last year, primarily due to a decrease in royalty payments [12] - Research and development expenses increased to $11.6 million in Q1 2025, driven by costs associated with the bosakitug program [13] Corporate Updates - Aclaris has appointed Dr. Jesse W. Hall as Chief Medical Officer, bringing extensive experience in drug development [10] - The company is exploring additional non-dilutive financing opportunities following the lifting of an injunction against Sun Pharmaceuticals, which may provide a financial asset for monetization [11]
Aclaris Therapeutics Secures U.S. Food and Drug Administration IND Clearance for ATI-052, Enabling Advancement of its Novel Bispecific Anti-TSLP/IL-4R Investigational Antibody
GlobeNewswire· 2025-04-22 10:59
- Initiation of Upcoming Phase 1a/1b Clinical Trial Expected in the Second Quarter of 2025 - WAYNE, Pa, April 22, 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 U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific ...
Aclaris Therapeutics to Participate in Two March Healthcare Conferences
GlobeNewswire· 2025-03-04 12:00
Core Insights - Aclaris Therapeutics, Inc. is participating in two healthcare conferences in March 2025, showcasing its focus on immuno-inflammatory diseases [1][5] - The company is a clinical-stage biopharmaceutical firm developing novel product candidates to address unmet needs in immuno-inflammatory diseases [3] Conference Participation - Aclaris' CEO Dr. Neal Walker and senior leadership will engage in a fireside chat at the Leerink Partners Global Healthcare Conference on March 11, 2025, at 3:00 PM EDT [5] - Aclaris will also participate in a virtual fireside chat during the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025, at 9:00 AM EDT [5] Company Overview - Aclaris Therapeutics is focused on developing a pipeline of product candidates aimed at patients with immuno-inflammatory diseases who currently lack satisfactory treatment options [3] - The company boasts a multi-stage portfolio supported by a robust research and development engine [3]
Aclaris Therapeutics(ACRS) - 2024 Q4 - Annual Report
2025-02-27 21:30
Financial Performance - The company reported a net loss of $902.9 million in 2024, compared to a net loss of $770.8 million in 2023, representing an increase in losses of about 17.0%[554]. - Total revenue for 2024 was $18.72 million, a decrease of 40.5% from $31.25 million in 2023[556]. - Net loss for 2024 was $132.07 million, compared to a net loss of $88.48 million in 2023, representing a 49.2% increase in losses[556]. - The Company reported a comprehensive loss of $131.86 million for 2024, compared to a comprehensive loss of $87.69 million in 2023[556]. - The Company reported segment operating losses of $123.8 million for the year ended December 31, 2024, compared to $69.5 million for the year ended December 31, 2023[688]. - The Company’s total loss before income taxes was $132.1 million for the year ended December 31, 2024, compared to $88.8 million in 2023[688]. Assets and Liabilities - Total assets increased to $220.3 million as of December 31, 2024, compared to $197.4 million in 2023, reflecting a growth of approximately 11.4%[554]. - Total stockholders' equity slightly decreased to $155.6 million in 2024 from $157.2 million in 2023, a reduction of approximately 1.0%[554]. - Total current liabilities increased to $31.6 million in 2024 from $30.9 million in 2023, reflecting a growth of about 2.3%[554]. - The Company has an accumulated deficit of $902.86 million as of December 31, 2024[563]. - The Company has contingent consideration liabilities of $8.7 million as of December 31, 2024, up from $6.2 million in 2023, related to the acquisition of Confluence[676]. Cash and Cash Equivalents - Cash and cash equivalents decreased to $24.6 million in 2024 from $39.9 million in 2023, a decline of about 38.3%[554]. - The company had cash, cash equivalents, and marketable securities totaling $203.9 million as of December 31, 2024[563]. - Cash equivalents decreased from $32.177 million in 2023 to $22.245 million in 2024, a decline of about 30.9%[618]. Research and Development - Research and development expenses for 2024 were $33.59 million, down from $98.38 million in 2023, a reduction of 65.8%[556]. - Total research and development project spend was $17.9 million for the year ended December 31, 2024, down from $67.6 million in 2023[688]. - The Company incurred $86.91 million in in-process research and development expenses in 2024, significantly higher than $6.63 million in 2023[556]. Stock and Equity - The weighted average common shares outstanding increased to 107,850,124 in 2024 from 77,296,665 in 2023, reflecting a 39.5% increase[558]. - The Company issued warrants with an estimated fair value of $44.8 million, allowing the purchase of 14,281,985 shares of common stock at an initial exercise price of $0.00001 per share[631]. - The total potential shares of common stock excluded from the calculation of diluted net loss per share increased to 8,998,118 in 2024 from 7,941,395 in 2023, reflecting an increase in stock options and RSUs[648]. Revenue and Licensing - The Company recognized licensing revenue of $3.0 million in 2024 and $15.0 million in 2023 from the license agreement with Sun Pharmaceutical Industries, Inc.[669]. - The Company recognized licensing revenue of $13.2 million from Eli Lilly and Company in 2024, compared to $12.7 million in 2023[672]. - The Company’s licensing revenue was $12.7 million for the year ended December 31, 2024, compared to $14.7 million in 2023[688]. Employee Compensation and Workforce - Employee compensation expenses increased from $3.910 million in 2023 to $4.979 million in 2024, an increase of about 27.3%[627]. - The Company approved a workforce reduction of approximately 46% in December 2023, resulting in a severance expense of $2.7 million and cash severance payments of $5.6 million for the year ended December 31, 2024[683]. Tax and Deferred Tax Assets - The effective income tax rate for the Company was (0.0)% in 2024, compared to (0.4)% in 2023[658]. - The valuation allowance for deferred tax assets increased from $195.1 million in 2023 to $224.4 million in 2024, primarily due to increases in net operating losses and research and development tax credit carryforwards[661]. - As of December 31, 2024, the Company had federal net operating loss carryforwards of $469.4 million and state net operating loss carryforwards of $401.1 million, both beginning to expire in 2032[660].
Aclaris Therapeutics(ACRS) - 2024 Q4 - Annual Results
2025-02-27 12:17
Financial Performance - Aclaris reported a net loss of $96.6 million for Q4 2024, compared to a net loss of $1.5 million in Q4 2023, and a total net loss of $132.1 million for the full year 2024, up from $88.5 million in 2023 [7][18]. - Total revenue for Q4 2024 was $9.2 million, down from $17.6 million in Q4 2023, with full-year revenue of $18.7 million compared to $31.2 million in 2023 [8][18]. - Net loss for the year ended December 31, 2024, was $132,065,000, compared to a net loss of $88,481,000 in 2023, indicating a decline of 49.2% [22]. - In-process research and development expense significantly increased to $86,905,000 in 2024 from $6,629,000 in 2023, marking a rise of 1,313.5% [22]. - Stock-based compensation expense decreased to $10,856,000 in 2024 from $20,542,000 in 2023, a reduction of 47.3% [22]. Cash and Assets - Aclaris had cash, cash equivalents, and marketable securities of $203.9 million as of December 31, 2024, an increase from $181.9 million at the end of 2023, providing a cash runway expected into 2028 [6]. - Cash, cash equivalents, and marketable securities increased to $203,896,000 as of December 31, 2024, up from $181,877,000 in 2023, representing an increase of 12.4% [20]. - Total assets rose to $220,327,000 in 2024, compared to $197,405,000 in 2023, reflecting an increase of 11.6% [20]. - Total liabilities increased to $64,773,000 in 2024 from $40,226,000 in 2023, which is an increase of 61.0% [20]. - Total stockholders' equity decreased slightly to $155,554,000 in 2024 from $157,179,000 in 2023, a decline of 1.0% [20]. - Common stock outstanding rose significantly to 107,850,124 shares in 2024 from 70,894,889 shares in 2023, an increase of 51.9% [20]. Expenses - Research and development expenses decreased to $9.0 million in Q4 2024 from $26.6 million in Q4 2023, with full-year R&D expenses at $33.6 million compared to $98.4 million in 2023 [9][18]. - General and administrative expenses were $5.0 million for Q4 2024, down from $8.2 million in Q4 2023, with full-year G&A expenses at $22.2 million compared to $32.4 million in 2023 [10][18]. - Net cash used in operating activities improved to $20,075,000 in 2024 from $78,325,000 in 2023, a reduction of 74.4% [22]. - Changes in operating assets and liabilities resulted in a positive cash flow of $10,922,000 in 2024, compared to $9,389,000 in 2023, an increase of 16.3% [22]. Research and Development Plans - Aclaris expects Phase 2 data for bosakitug in severe asthma and chronic rhinosinusitis with nasal polyps in the first half of 2025, which will inform internal development programs [3][4]. - The company plans to initiate a Phase 2b trial for bosakitug in atopic dermatitis in the first half of 2025 [4][6]. - Aclaris announced a plan to file an Investigational New Drug (IND) application for ATI-052 in Q1 2025, with a Phase 1 clinical trial to follow [8][18]. Financing Activities - Aclaris completed an $80 million private placement in November 2024 to strengthen its cash position [10].
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update
GlobeNewswire· 2025-02-27 11:59
Core Insights - Aclaris Therapeutics is positioned for multiple clinical catalysts in 2025, particularly with Phase 2 data for bosakitug in severe asthma and chronic rhinosinusitis with nasal polyps expected in the first half of 2025 [1][3] - The company has a strong cash runway expected to last into 2028, bolstered by a recent $80 million private placement [5][7] Pipeline Developments - Aclaris has announced an exclusive global license agreement with Biosion, acquiring rights to bosakitug (ATI-045) and ATI-052, which are potential best-in-class biologic assets [4] - Phase 2 studies for bosakitug in Chinese patients with severe asthma and chronic rhinosinusitis are ongoing, with data expected in the first half of 2025 [4][3] - A Phase 2b trial for bosakitug in atopic dermatitis is set to begin enrollment in the first half of 2025 [1][4] - Top-line results from a Phase 2a trial of ATI-2138 in atopic dermatitis are also anticipated in the first half of 2025 [3][4] Financial Performance - For Q4 2024, Aclaris reported a net loss of $96.6 million, compared to a net loss of $1.5 million in Q4 2023 [8] - Total revenue for Q4 2024 was $9.2 million, down from $17.6 million in Q4 2023, primarily due to a one-time payment received in the previous year [9] - Research and development expenses decreased to $9.0 million in Q4 2024 from $26.6 million in the prior year [10] - General and administrative expenses also saw a reduction, totaling $5.0 million in Q4 2024 compared to $8.2 million in Q4 2023 [11] Leadership Changes - Dr. Neal Walker has been appointed as the Chief Executive Officer, bringing extensive experience as a co-founder of Aclaris [14] - Hugh Davis has joined as President and Chief Operating Officer, contributing over 35 years of experience in biologics development [14]