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- Multiple Catalysts in Immuno-Inflammatory Indications Anticipated in 2025 and 2026 -
- Expected Cash Runway Extended Through the First Half of 2028 -
- Phase 2 Results Received to Date from Chinese Partner CTTQ Provide Clinical Evidence of Enhanced Potency of Bosakitug (ATI-045) and Opportunity for Development Partnerships -
- Investigational New Drug (IND) Application for Bispecific Antibody ATI-052 Cleared by U.S. Food and Drug Administration -
WAYNE, Pa., May 08, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2025 and provided a corporate update.
“We are entering into a potentially transformative multi-year period for Aclaris, with important milestones throughout our business that we believe will position us for future growth,” stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. “Ensuring successful and timely execution of our clinical programs is our priority, and given the realities of today’s financial market environment, it’s imperative that we continue to do so in a manner that efficiently utilizes our capital. As such, we’ve announced that further global development of bosakitug - our uniquely potent anti-TSLP monoclonal antibody - in respiratory indications will be dependent on partnerships. Regarding our internal programs, we expect to initiate new clinical trials with bosakitug; ATI-2138, our highly selective oral ITK/JAK3 inhibitor; and ATI-052, our potential best-in-class bispecific anti-TSLP/IL-4R antibody, for which we recently received IND clearance from the FDA. Work is also ongoing toward next-generation small molecule kinase inhibitors and biologic antagonists of immuno-inflammatory pathways to further expand our pipeline and continue our innovative work in I&I.”
“Importantly, we have the cash we believe we need to execute our plan,” continued Dr. Walker. “Our expected cash runway now extends through the first half of 2028, and we will continue to practice rigorous financial stewardship with a goal of extending our runway further by exploring additional non-dilutive opportunities.”
First Quarter 2025 Highlights and Recent Updates
Pipeline:
Bosakitug (ATI-045): Investigational Anti-TSLP monoclonal antibody
ATI-2138: Investigational oral covalent ITK/JAK3 inhibitor
ATI-052: Investigational bispecific anti-TSLP/IL4R monoclonal antibody
Next Generation Kinase and Cytokine Signaling Pathway Inhibitor Development:
Corporate:
First Quarter 2025 Financial Results
As of March 31, 2025, Aclaris had cash, cash equivalents and marketable securities of $190.5 million compared to $203.9 million as of December 31, 2024. The Company believes that its cash, cash equivalents and marketable securities will be sufficient to fund its operations through the first half of 2028, without giving effect to any potential business development transactions or financing activities.
Net loss was $15.1 million for the first quarter of 2025 compared to $16.9 million for the first quarter of 2024.
Total revenue was $1.5 million for the first quarter of 2025 compared to $2.4 million for the first quarter of 2024. The decrease was primarily driven by the sale of a portion of royalty payments under the Company’s agreement with Eli Lilly and Company to OCM IP Healthcare Portfolio IP, an investment vehicle for Ontario Municipal Employees Retirement System (OMERS), in July 2024.
Research and development (R&D) expenses were $11.6 million for the quarter ended March 31, 2025 compared to $9.8 million for the prior year period. The increase was primarily driven by expenses related to the Company’s bosakitug program, specifically preclinical and clinical development expenses associated with startup activities for a Phase 2 trial in AD. The increase was partially offset by a reduction in development expenses for zunsemetinib and lepzacitinib and lower compensation-related expenses.
General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2025 compared to $6.8 million for the corresponding prior year period. The decrease was primarily due to a reduction in personnel expenses as a result of lower headcount and lower termination benefits.
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 and ATI-052, including the anticipated timing for the initiation of its Phase 2 trial of bosakitug in AD and its Phase 1 trial of ATI-052, the timing for reporting the results of its Phase 2a trial of ATI-2138 in AD, and its plans to explore additional future indications for ATI-2138 including AA and vitiligo, its plans for its preclinical development programs and timing of IND submissions, its plans to monetize the Sun Pharma financial asset, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations through the first 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 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
[email protected]
Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
[email protected]
| Aclaris Therapeutics, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues: | ||||||||
| Contract research | $ | 445 | $ | 657 | ||||
| Licensing | 1,010 | 1,741 | ||||||
| Total revenue | 1,455 | 2,398 | ||||||
| Costs and expenses: | ||||||||
| Cost of revenue(1) | 506 | 809 | ||||||
| Research and development(1) | 11,584 | 9,845 | ||||||
| General and administrative(1) | 6,139 | 6,844 | ||||||
| Licensing | 1,010 | 1,031 | ||||||
| Revaluation of contingent consideration | 300 | 2,800 | ||||||
| Total costs and expenses | 19,539 | 21,329 | ||||||
| Loss from operations | (18,084 | ) | (18,931 | ) | ||||
| Other income: | ||||||||
| Interest income | 2,166 | 1,990 | ||||||
| Non-cash royalty income | 833 | — | ||||||
| Total other income | 2,999 | 1,990 | ||||||
| Net loss | $ | (15,085 | ) | $ | (16,941 | ) | ||
| Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.24 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 122,390,303 | 71,074,858 | ||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||
| Cost of revenue | $ | 219 | $ | 252 | ||||
| Research and development | 1,185 | (29 | ) | |||||
| General and administrative | 2,131 | 1,866 | ||||||
| Total stock-based compensation expense | $ | 3,535 | $ | 2,089 | ||||
| Aclaris Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data) | ||||||
| March 31, | December 31, | |||||
| 2025 | 2024 | |||||
| Cash, cash equivalents and marketable securities | $ | 190,525 | $ | 203,896 | ||
| Total assets | $ | 198,094 | $ | 220,327 | ||
| Total current liabilities | $ | 21,514 | $ | 31,596 | ||
| Total liabilities | $ | 54,028 | $ | 64,773 | ||
| Total stockholders' equity | $ | 144,066 | $ | 155,554 | ||
| Common stock outstanding | 108,265,529 | 107,850,124 | ||||
| Aclaris Therapeutics, Inc. Selected Consolidated Cash Flow Data (unaudited, in thousands) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net loss | $ | (15,085 | ) | $ | (16,941 | ) | ||
| Depreciation and amortization | 128 | 243 | ||||||
| Stock-based compensation expense | 3,535 | 2,089 | ||||||
| Revaluation of contingent consideration | 300 | 2,800 | ||||||
| Changes in operating assets and liabilities | (1,935 | ) | (9,006 | ) | ||||
| Net cash used in operating activities | $ | (13,057 | ) | $ | (20,815 | ) | ||
| May-28 | |
| May-09 | |
| May-08 | |
| May-08 | |
| May-08 | |
| Apr-29 | |
| Apr-23 |
Aclaris Therapeutics receives FDA approval for Phase Ia/Ib trial of ATI-052
ACRS
Clinical Trials Arena
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| Apr-22 | |
| Mar-19 | |
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