WAYNE, Pa., May 07, 2024 (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 2024 and provided a corporate update.
“We are pleased to announce that following a review of the potential development pathways for ATI-2138, our investigational ITK/JAK3 compound with best-in-class potential, we have decided to progress ATI-2138 into a proof-of-concept Phase 2a trial in patients with moderate to severe atopic dermatitis,” stated Dr. Neal Walker, co-founder and Interim Chief Executive Officer & President of Aclaris. “Across all of our programs, we remain focused on executing a capital efficient strategy to advance novel immuno-inflammatory therapies.”
Research and Development Highlights:
Financial Highlights:
Liquidity and Capital Resources
As of March 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $161.4 million compared to $181.9 million as of December 31, 2023. A majority of cash expenditures in the first quarter of 2024 were related to payments associated with exit activities, including the wind down of discontinued R&D programs and the previously announced reduction in force. Aclaris anticipates payments associated with these activities to be substantially completed by the second quarter of 2024. As a result, Aclaris expects significantly lower quarterly cash expenditures in future quarters, without giving effect to any potential business development activities resulting from its ongoing strategic review of its business.
Financial Results
First Quarter 2024
Conference Call and Webcast
As previously disclosed on April 30, 2024, management will host a conference call and webcast, with an accompanying slide presentation, at 5:00 PM ET today to provide a corporate update. To access the live webcast of the call and the accompanying slide presentation, please visit the “Events” page of the “Investors” section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com.
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, including its plans to seek a development and commercialization partner for lepzacitinib, the clinical development of ATI-2138, and its plan to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib, as well as Aclaris’ expectations regarding the wind down of discontinued R&D programs and costs associated with its recent reduction in force and the associated impact on anticipated cash burn, and its strategic review of its business. 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, 2023, 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, Inc. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Contract research | $ | 657 | $ | 889 | ||||
| Licensing | 1,741 | 1,639 | ||||||
| Total revenue | 2,398 | 2,528 | ||||||
| Costs and expenses: | ||||||||
| Cost of revenue (1) | 809 | 808 | ||||||
| Research and development (1) | 9,845 | 22,587 | ||||||
| General and administrative (1) | 6,844 | 8,790 | ||||||
| Licensing | 1,031 | 1,061 | ||||||
| Revaluation of contingent consideration | 2,800 | (800 | ) | |||||
| Total costs and expenses | 21,329 | 32,446 | ||||||
| Loss from operations | (18,931 | ) | (29,918 | ) | ||||
| Other income, net | 1,990 | 1,758 | ||||||
| Net loss | $ | (16,941 | ) | $ | (28,160 | ) | ||
| Net loss per share, basic and diluted | $ | (0.24 | ) | $ | (0.42 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 71,074,858 | 66,872,778 | ||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||
| Cost of revenue | $ | 252 | $ | 299 | ||||
| Research and development | (29 | ) | 2,602 | |||||
| General and administrative | 1,866 | 3,905 | ||||||
| Total stock-based compensation expense | $ | 2,089 | $ | 6,806 | ||||
| Aclaris Therapeutics, Inc. Selected Consolidated Balance Sheet Data (unaudited, in thousands, except share data) | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 161,365 | $ | 181,877 | ||||
| Total assets | $ | 174,065 | $ | 197,405 | ||||
| Total current liabilities | $ | 20,080 | $ | 30,952 | ||||
| Total liabilities | $ | 32,051 | $ | 40,226 | ||||
| Total stockholders' equity | $ | 142,014 | $ | 157,179 | ||||
| Common stock outstanding | 71,248,017 | 70,894,889 | ||||||
| Aclaris Therapeutics, Inc. Selected Consolidated Cash Flow Data (unaudited, in thousands) | ||||||||
| March 31, 2024 | March 31, 2023 | |||||||
| Net loss | $ | (16,941 | ) | $ | (28,160 | ) | ||
| Depreciation and amortization | 243 | 198 | ||||||
| Stock-based compensation expense | 2,089 | 6,806 | ||||||
| Revaluation of contingent consideration | 2,800 | (800 | ) | |||||
| Changes in operating assets and liabilities | (9,006 | ) | (4,397 | ) | ||||
| Net cash used in operating activities | $ | (20,815 | ) | $ | (26,353 | ) | ||
Aclaris Therapeutics Contact:
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| Last Trade: | US$3.90 |
| Daily Change: | -0.69 -15.03 |
| Daily Volume: | 5,745,493 |
| Market Cap: | US$278.230M |
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