Aclaris Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Aclaris Therapeutics (NASDAQ: ACRS) reported Q3 2025 results and a corporate update highlighting clinical progress and financial position. The company posted positive Phase 2a topline and EADV presentation data for ITK/JAK3 inhibitor ATI-2138 (week 4 EASI -77%, BSA -64%, PP-NRS -45%) and plans a Phase 2 in an additional indication in H1 2026. Topline readouts for bispecific ATI-052 Phase 1a and anti-TSLP bosakitug Phase 2 are expected in early and H2 2026, respectively. Cash, cash equivalents and marketable securities were $167.2M as of Sept 30, 2025, with a runway into H2 2028. Q3 net loss widened to $14.6M.
Positive
- ATI-2138 Phase 2a: EASI -77% at week 4 (n=9)
- Cash runway into H2 2028 with $167.2M liquidity
- Planned Phase 2 start for ATI-2138 in H1 2026
- Topline results planned: ATI-052 early 2026; bosakitug H2 2026
Negative
- Q3 2025 net loss $14.6M vs $7.6M prior-year quarter
- Cash declined from $203.9M (Dec 31, 2024) to $167.2M (Sept 30, 2025)
- Q3 R&D expense increased to $13.0M from $6.0M year‑ago
News Market Reaction 28 Alerts
On the day this news was published, ACRS gained 0.44%, reflecting a mild positive market reaction. Argus tracked a peak move of +9.7% during that session. Our momentum scanner triggered 28 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $1M to the company's valuation, bringing the market cap to $285M at that time.
Data tracked by StockTitan Argus on the day of publication.
- Positive Results from Phase 2a Trial of ITK/JAK3 Inhibitor ATI-2138 Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Further Validating ITK as Therapeutic Target; Initiation of Phase 2 Trial in an Additional Indication Expected in the First Half of 2026 -
- Timelines Reiterated for Top Line Clinical Results from Ongoing Trials of Investigational Anti-TSLP Monoclonal Antibody Bosakitug (ATI-045) and Anti-TSLP/IL-4R Bispecific Antibody ATI-052 -
- Initiation of Phase 1b Proof-of-Concept Trials of ATI-052 in Asthma and Atopic Dermatitis (AD) Expected in the First Half of 2026 -
- Strong Cash Runway Expected to Fund Operations into the Second Half of 2028 -
WAYNE, Pa., Nov. 06, 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 its financial results for the third quarter of 2025 and provided a corporate update.
“Aclaris is advancing a diversified pipeline of product candidates designed to overcome the limitations of existing therapies for certain immuno-inflammatory disorders, and the third quarter was a period of continued execution in that regard,” said Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “The strong top line results from our Phase 2a trial of ATI-2138 in atopic dermatitis are emblematic of our execution during the quarter. As we described during our October R&D Day, our progress is tangible and significant. We have two immune franchise areas in oral kinase inhibitors and biologics which we expect to drive four clinical stage product candidates in 2026, addressing validated and therapeutically relevant immune targets. We have an expected cash runway that provides nearly three years of capital with opportunities to expand it further without dilution and look forward to a rich calendar of anticipated clinical milestones and data events throughout 2026 and 2027.”
Third Quarter 2025 Highlights and Recent Updates
Pipeline:
Oral Inhibitors: ITK Franchise
- Announced Anticipated Phase 2 Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, in an Additional Indication: Aclaris expects to further assess ATI-2138 in additional unaddressed chronic, inflammatory, immune-mediated disorders, such as Lichen planus, scarring alopecias, and alopecia areata. The Company intends to initiate a Phase 2 trial in the first half of 2026.
- Achieved Primary and Key Secondary Endpoints in Phase 2a Trial of ATI-2138: Positive top line results from this open-label, single arm trial further confirmed the favorable tolerability profile of ATI-2138, demonstrated clinically meaningful improvements from baseline in assessments of disease severity in patients with moderate-to-severe atopic dermatitis receiving low doses of ATI-2138, and validated ITK as a therapeutic target. (press release here)
- Additional Results on Robust Clinical Activity and Reductions in Fibrosis and Systemic Inflammation from ATI-2138 Phase 2a Trial Provided in Oral Presentation During the 2025 European Academy of Dermatology and Venereology (EADV) Congress: Additional results included week 4 decreases (n=9) of
77% in Eczema Area and Severity Index (EASI) score (p<0.001), a64% in Body Surface Area (BSA) score (p<0.001), and45% in Peak Pruritus Numerical Rating Scale (PP-NRS) (p<0.01). These changes were maintained through end of treatment. Transcriptomic and proteomic analyses showed significant downregulation of the Th1, Th2 and Th17 markers along with downregulation of fibrosis. The observed reductions in inflammatory and fibrosis biomarkers in skin positively and strongly correlated with improvements in clinical scores. - Announced Intent to File Initial Investigational New Drug (IND) Application for Next-Generation JAK-Sparing ITK Inhibitor in the Second Half of 2026: Aclaris’ next-generation ITK-selective inhibitors have extended half-lives and show complete ITK occupancy at very low doses. These compounds are significantly more efficient inactivators of ITK as compared to other ITK inhibitors in development and potently block Th2 function and differentially modulate Th1 activation.
Biologics: Antibody Franchise
- Top Line Results Expected in Early 2026 from Phase 1a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Portion of Ongoing Phase 1a/1b Program of Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052: Dosing is complete in the Phase 1a SAD portion and ongoing in the Phase 1a MAD portion of the randomized, blinded, placebo-controlled Phase 1a/1b program. Aclaris expects to complete the Phase 1a portion by year-end 2025 and provide top line results in early 2026.
- Announced Intent to Conduct Phase 1b Proof-of-Concept (POC) Trials of ATI-052 in Asthma and Atopic Dermatitis: Following completion of the Phase 1a SAD/MAD portion, the Company expects to initiate these Phase 1b POC studies in the first half of 2026, with top line results expected in the second half of 2026.
- Top Line Results Expected in the Second Half of 2026 from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Patient enrollment is ongoing in the randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate bosakitug in approximately ninety (90) patients with moderate-to-severe AD. The Company expects to provide top line results in the second half of 2026.
Corporate:
- Strong Cash Runway Funds the Company’s Planned Operations into the Second Half of 2028: The Company is assessing potential non-dilutive opportunities to extend the cash runway further.
- Provided Corporate Update During the Company’s October 14, 2025, R&D Day event: Patient Focused Innovation: Addressing Gaps in Immuno-Inflammatory Markets: Aclaris hosted an R&D Day in New York City that highlighted recent progress and expected milestones across the Company’s pipeline, including those related to its preclinical next generation ITK inhibitor program and multispecific antibodies and its ongoing clinical programs. The event featured members of Aclaris’ executive team and leading experts in the fields of pulmonology and dermatology. A replay of the event is available on the Events page of the Aclaris corporate website here.
Financial Results
Liquidity and Capital Resources
As of September 30, 2025, Aclaris had cash, cash equivalents and marketable securities of
Third Quarter 2025 and Year-to-Date 2025
Net loss was
Total revenue was
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Revaluation of contingent consideration resulted in a
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its plans for its development programs for bosakitug, ATI-2138, ATI-052, and its next generation ITK inhibitors, including the timing of reporting results from its Phase 2 trial of bosakitug in AD and its Phase 1a assessment of ATI-052, the timing to initiate and report results from Phase 1b trials of ATI-052 in asthma and atopic dermatitis, the potential to evaluate and the timing to initiate a Phase 2 trial of ATI-2138 in additional indications, the timing to file an IND for its next-generation ITK inhibitor program, the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into the second half of 2028, and the Company’s plans to pursue non-dilutive financing opportunities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the “Risk Factors” section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Aclaris Therapeutics Contacts:
Kevin Balthaser
Chief Financial Officer
(484) 329-2178
kbalthaser@aclaristx.com
Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com
| Aclaris Therapeutics, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Revenues: | |||||||||||||||
| Contract research | $ | 485 | $ | 645 | $ | 1,372 | $ | 1,926 | |||||||
| Licensing | 2,814 | 3,701 | 5,159 | 7,583 | |||||||||||
| Total revenue | 3,299 | 4,346 | 6,531 | 9,509 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Cost of revenue(1) | 538 | 654 | 1,559 | 2,087 | |||||||||||
| Research and development(1) | 13,028 | 5,956 | 36,061 | 24,560 | |||||||||||
| General and administrative(1) | 4,871 | 5,653 | 16,396 | 17,249 | |||||||||||
| Licensing | 1,911 | 1,754 | 4,256 | 4,070 | |||||||||||
| Revaluation of contingent consideration | 100 | 800 | 1,900 | 3,800 | |||||||||||
| Total costs and expenses | 20,448 | 14,817 | 60,172 | 51,766 | |||||||||||
| Loss from operations | (17,149 | ) | (10,471 | ) | (53,641 | ) | (42,257 | ) | |||||||
| Other income: | |||||||||||||||
| Interest income | 1,819 | 1,991 | 6,003 | 5,850 | |||||||||||
| Non-cash royalty income | 716 | 894 | 2,510 | 894 | |||||||||||
| Total other income | 2,535 | 2,885 | 8,513 | 6,744 | |||||||||||
| Net loss | $ | (14,614 | ) | $ | (7,586 | ) | $ | (45,128 | ) | $ | (35,513 | ) | |||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.11 | ) | $ | (0.37 | ) | $ | (0.50 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 122,619,311 | 71,381,731 | 122,531,032 | 71,249,813 | |||||||||||
| (1) Amounts include stock-based compensation expense as follows: | |||||||||||||||
| Cost of revenue | $ | 191 | $ | 232 | $ | 600 | $ | 707 | |||||||
| Research and development | 964 | 1,124 | 3,255 | 2,192 | |||||||||||
| General and administrative | 1,705 | 1,648 | 5,603 | 5,097 | |||||||||||
| Total stock-based compensation expense | $ | 2,860 | $ | 3,004 | $ | 9,458 | $ | 7,996 | |||||||
| Aclaris Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data) | |||||||
| September 30, | December 31, | ||||||
| 2025 | 2024 | ||||||
| Cash, cash equivalents and marketable securities | $ | 167,209 | $ | 203,896 | |||
| Total assets | $ | 175,534 | $ | 220,327 | |||
| Total current liabilities | $ | 25,631 | $ | 31,596 | |||
| Total liabilities | $ | 55,434 | $ | 64,773 | |||
| Total stockholders' equity | $ | 120,100 | $ | 155,554 | |||
| Common stock outstanding | 108,342,592 | 107,850,124 | |||||
| Aclaris Therapeutics, Inc. Selected Consolidated Cash Flow Data (unaudited, in thousands) | |||||||
| Nine Months Ended | |||||||
| September 30, | |||||||
| 2025 | 2024 | ||||||
| Net loss | $ | (45,128 | ) | $ | (35,513 | ) | |
| Depreciation and amortization | 352 | 664 | |||||
| Stock-based compensation expense | 9,458 | 7,996 | |||||
| Revaluation of contingent consideration | 1,900 | 3,800 | |||||
| Changes in operating assets and liabilities | (564 | ) | 11,916 | ||||
| Net cash used in operating activities | $ | (33,982 | ) | $ | (11,137 | ) | |
FAQ
What were the key ATI-2138 results ACRS reported on Nov 6, 2025?
When will ACRS begin the next Phase 2 trial for ATI-2138?
What is the timing for ATI-052 and bosakitug topline data for ACRS?
How long is ACRS's cash runway after Q3 2025 results?
Did ACRS's profitability or expenses change materially in Q3 2025?
