| - Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Anti-TSLP/IL-4Rα Bispecific Antibody ATI-052 Support Rapid Clinical Advancement; Complete Top Line Results Expected in the Second Quarter of 2026 - |
| - Phase 1b Proof-of-Concept Trials of ATI-052 in Atopic Dermatitis (AD) and Asthma Underway; Top Line Results from Both Trials Anticipated in the Second Half of 2026 - |
| - Investigational New Drug (IND) Application for Lead ITK Inhibitor Candidate ATI-9494 Expected in the Second Half of 2026 - |
| - ATI-2138, Aclaris’ Investigational Inhibitor of ITK and JAK3, Demonstrated Potential Best-in-Class Hair Regrowth in Murine Alopecia Model - |
“2025 was a year of strong business execution and continued momentum in each of our potential best-in-class programs and positioned us for an exciting 2026 with important milestones and data readouts expected from each program,” stated Dr.
Fourth Quarter 2025 Highlights and Recent Updates
Pipeline:
Biologics: Antibody Franchise
- Provided Positive Interim Results of Phase 1a Single (SAD) and Multiple Ascending Dose (MAD) Trial of Investigational Bispecific Anti-TSLP/IL-4Rα Antibody ATI-052; Complete Top Line Results from SAD and MAD Cohorts Expected in the Second Quarter of 2026: ATI-052 was well tolerated and demonstrated a favorable safety profile across all single and multiple ascending dose cohorts in this Phase 1a trial. Interim results included a dose proportional pharmacokinetic (PK) profile and concentration-dependent pharmacodynamics (PD) validating the potency and specificity of the compound, including robust target engagement and near complete target occupancy even at very low doses. These results support the potential for up to every three months dosing. Additional SAD and MAD results from this trial are expected in the second quarter of 2026. (press release here)
- Announced Initiation of Two Phase 1b Proof-of-Concept (POC) Trials of ATI-052: Following positive interim Phase 1a SAD/MAD results, the Company has initiated Phase 1b POC studies in AD and asthma. Top line results from both trials are expected in the second half of 2026. (press releases here and here)
- Planning Underway for Phase 2b
Program for ATI-052 : Planning is ongoing for a Phase 2b program encompassing asthma and AD as potential first indications. The Company expects to initiate this program in the second half of 2026.
- Confirmed Expectation of Top Line Results in the Second Half of 2026 from Ongoing Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: This randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate bosakitug in approximately 96 patients with moderate-to-severe AD.
Oral Inhibitors: ITK Franchise
- Aclaris’ Lead ITK Inhibitor ATI-9494 Advancing Toward Expected Investigational New Drug (IND) Application in the Second Half of 2026: Aclaris’ lead ITK inhibitor candidate ATI-9494 has demonstrated potent blockade of Th1 and Th2 responses, a prolonged half-life, and high potency against ITK, potentially enabling low drug burden, dosing flexibility, and once daily (QD) administration across a broad range of disease indications. Aclaris intends to file an IND for ATI-9494 in the second half of 2026.
- ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3, Demonstrated Rapid and Sustained Hair Regrowth in Validated Murine Model of Severe Alopecia Areata (AA), Further Validating Best-in-Class Potential: ATI-2138 and ritlecitinib were assessed compared to control in a reversal model of murine alopecia universalis, the most severe AA phenotype. ATI-2138 demonstrated potential best-in-class results including rapid, near complete, and sustained hair regrowth compared to control and ritlecitinib including mean hair regrowth of 93% for ATI-2138 at week 6 (end of study) compared to 78% for the same dose of ritlecitinib. Mice receiving control showed no improvement in hair regrowth. The Company is completing the assessment of additional indications that are relevant to the dual pharmacology and mechanism of action, including certain alopecias and other inflammatory disorders. (press release here)
Financial Results
Liquidity and Capital Resources
As of
Fourth Quarter and Full Year 2025
Net loss was
Total revenue was
Research and development (R&D) expenses were
General and administrative (G&A) expenses were
Licensing expenses were
Revaluation of contingent consideration resulted in a
During the quarter and year ended
About
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-052, ATI-2138 and ATI-9494, including the timing of reporting complete results from its Phase 1a SAD/MAD trial, results from its Phase 2 trial of bosakitug in AD, and results from its Phase 1b trials of ATI-052 in asthma and AD, the timing of initiating a Phase 2b program for ATI-052 and the timing to file an IND for ATI-9494 and its dosing potential, the potential for ATI-052 to have up to every three-month dosing, the therapeutic potential of its product candidates and the potential for such candidates to be best-in-class, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into the second half of 2028. 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
Aclaris Therapeutics Contacts:
Chief Financial Officer
(484) 329-2178
kbalthaser@aclaristx.com
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com
Consolidated Statements of Operations (unaudited, in thousands, except share and per share data) |
||||||||||||||||
| Three Months Ended |
Year Ended |
|||||||||||||||
| 2025 |
2024 |
2025 |
2024 |
|||||||||||||
| Revenues: | ||||||||||||||||
| Contract research | $ | 500 | $ | 615 | $ | 1,872 | $ | 2,541 | ||||||||
| Licensing | 795 | 8,596 | 5,954 | 16,179 | ||||||||||||
| Total revenue | 1,295 | 9,211 | 7,826 | 18,720 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of revenue(1) | 532 | 705 | 2,091 | 2,792 | ||||||||||||
| Research and development(1) | 16,584 | 9,026 | 52,645 | 33,586 | ||||||||||||
| General and administrative(1) | 5,576 | 4,954 | 21,972 | 22,203 | ||||||||||||
| Licensing | 937 | 8,596 | 5,193 | 12,666 | ||||||||||||
| Revaluation of contingent consideration | 400 | (1,300 | ) | 2,300 | 2,500 | |||||||||||
| In-process research and development | — | 86,905 | — | 86,905 | ||||||||||||
| Total costs and expenses | 24,029 | 108,886 | 84,201 | 160,652 | ||||||||||||
| Loss from operations | (22,734 | ) | (99,675 | ) | (76,375 | ) | (141,932 | ) | ||||||||
| Other income: | ||||||||||||||||
| Interest income | 1,634 | 2,103 | 7,637 | 7,953 | ||||||||||||
| Non-cash royalty income | 1,305 | 1,020 | 3,815 | 1,914 | ||||||||||||
| Total other income | 2,939 | 3,123 | 11,452 | 9,867 | ||||||||||||
| Net loss | $ | (19,795 | ) | $ | (96,552 | ) | $ | (64,923 | ) | $ | (132,065 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (1.01 | ) | $ | (0.53 | ) | $ | (1.71 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 122,664,768 | 95,305,768 | 122,564,741 | 77,296,665 | ||||||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||||||
| Cost of revenue | $ | 188 | $ | 231 | $ | 788 | $ | 938 | ||||||||
| Research and development | 1,003 | 943 | 4,258 | 3,135 | ||||||||||||
| General and administrative | 1,735 | 1,686 | 7,338 | 6,783 | ||||||||||||
| Total stock-based compensation expense | $ | 2,926 | $ | 2,860 | $ | 12,384 | $ | 10,856 | ||||||||
Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data) |
||||||
2025 |
2024 |
|||||
| Cash, cash equivalents and marketable securities | $ | 151,363 | $ | 203,896 | ||
| Total assets | $ | 160,460 | $ | 220,327 | ||
| Total current liabilities | $ | 28,645 | $ | 31,596 | ||
| Total liabilities | $ | 57,378 | $ | 64,773 | ||
| Total stockholders' equity | $ | 103,082 | $ | 155,554 | ||
| Common stock outstanding | 120,499,433 | 107,850,124 | ||||
Selected Consolidated Cash Flow Data (unaudited, in thousands) |
||||||||
| Year Ended |
||||||||
| 2025 |
2024 |
|||||||
| Net loss | $ | (64,923 | ) | $ | (132,065 | ) | ||
| Depreciation and amortization | 454 | 807 | ||||||
| Stock-based compensation expense | 12,384 | 10,856 | ||||||
| Revaluation of contingent consideration | 2,300 | 2,500 | ||||||
| In-process research and development expense | — | 86,905 | ||||||
| Changes in operating assets and liabilities | 2,672 | 10,922 | ||||||
| Net cash used in operating activities | $ | (47,113 | ) | $ | (20,075 | ) | ||
Source: Aclaris Therapeutics, Inc.