- Positive Clinical Results from Phase 2a Trial of ITK/JAK3 Inhibitor ATI-2138 Confirm Tolerability Profile, Show Strong Efficacy Signal, and Validate ITK as Therapeutic Target -
- Advanced Anti-TSLP Monoclonal Antibody Bosakitug (ATI-045) into Phase 2 Trial in Atopic Dermatitis (AD);
Patient Dosing Underway -
- Initiated Dosing in Phase 1a/1b
- Strong Cash Runway Expected to Fund Operations into the Second Half of 2028 -
“Aclaris is in a period of strong execution throughout the business as we advance our innovative therapies toward our goal of improving therapeutic options for patients with certain I&I diseases,” stated Dr.
Second Quarter 2025 Highlights and Recent Updates
Pipeline:
- Achieved Primary and Key Secondary Endpoints in Phase 2a Trial of ATI-2138, a Potent and Selective Investigational Inhibitor of ITK and JAK3: Positive 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 AD receiving low doses of ATI-2138, and validated ITK as a therapeutic target. Overall, these results provide evidence that the contribution of ITK may enable ATI-2138, even at low doses, to achieve efficacy results comparable to approved JAK inhibitors in moderate-to-severe AD, but with improved tolerability and without the significant safety risks typically associated with JAK inhibition. (press release here)
- Initiated Dosing in Phase 2 Trial of Potential Best-in-Class Investigational Anti-TSLP Monoclonal Antibody Bosakitug: Patient dosing is ongoing in the randomized, double-blind, placebo-controlled global 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. (press release here)
- Initiated Dosing in Phase 1a/1b
Program for Potential Best-in-Class Investigational Bispecific Anti-TSLP/IL-4R Antibody ATI-052 : Dosing is ongoing in the randomized, blinded, placebo-controlled Phase 1a portion, designed to evaluate single and multiple ascending doses of ATI-052 in healthy adults. The Phase 1b proof-of-concept portion in up to two indications is expected to follow the Phase 1a portion. Aclaris expects to complete the Phase 1a portion by year-end 2025 and provide top line results in early 2026, followed by top line results from the Phase 1b portion in the second half of 2026. (press release here)
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 Update on Senior Leadership:
Roland Kolbeck , Ph.D. has been appointed as Chief Scientific Officer, replacingJoe Monahan , Ph.D. who will remain with the Company as Special Scientific Advisor to the Chief Executive Officer through the first quarter of 2026 as part of his planned retirement. (press release here)
Financial Results
Liquidity and Capital Resources
As of
Second 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
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 and ATI-052, including the anticipated timing of reporting results from its Phase 2 trial of bosakitug in AD and its Phase 1a/1b program of ATI-052, the potential to evaluate ATI-052 in up to two undisclosed indications in a Phase 1b program, the development of ATI-2138 in AA and additional indications, 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
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
Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data) |
||||||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||||||
| 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(1) | 515 | 624 | 1,021 | 1,433 | ||||||||||||||||
| Research and development(1) | 11,449 | 8,759 | 23,033 | 18,604 | ||||||||||||||||
| General and administrative(1) | 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 | ||||||||||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||||||||||
| Cost of revenue | $ | 190 | $ | 223 | $ | 409 | $ | 475 | ||||||||||||
| Research and development | 1,106 | 1,097 | 2,291 | 1,068 | ||||||||||||||||
| General and administrative | 1,767 | 1,583 | 3,898 | 3,449 | ||||||||||||||||
| Total stock-based compensation expense | $ | 3,063 | $ | 2,903 | $ | 6,598 | $ | 4,992 | ||||||||||||
Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data) |
|||||
| 2025 | 2024 | ||||
| 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 (unaudited, in thousands) |
|||||||
| Six Months Ended | |||||||
| 2025 | 2024 | ||||||
| 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 | ) | |
Source: Aclaris Therapeutics, Inc.