Full Press Release Details
Aclaris Therapeutics Reports Third Quarter 2024 Financial Results and Provides a Corporate Update
- First Patient Dosed in ATI-2138 Phase 2a Trial in Atopic Dermatitis As Previously Announced; Top-line Data Anticipated in First Half of 2025 -
WAYNE, Pa., Nov. 06, 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 third quarter of 2024 and provided a corporate update.
"The third quarter of 2024 marked an important milestone for Aclaris with the dosing of our first patient in the Phase 2a trial of ATI-2138 for moderate to severe atopic dermatitis," said Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors of Aclaris. "This milestone, combined with our robust financial position, underscores our commitment to executing a capital-efficient development strategy."
Research and Development Highlights:
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $173.4 million compared to $181.9 million as of December 31, 2023.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund its operations into 2028, without giving effect to any potential business development transactions, financing activities or the outcome of its strategic review.
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, including the timing of top-line data, its plan to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib, the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into 2028, as well as its strategic review. 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 | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenues: | ||||||||||||
| Contract research | $ | 645 | $ | 705 | $ | 1,926 | $ | 2,469 | ||||
| Licensing | 3,701 | 8,577 | 7,583 | 11,210 | ||||||||
| Total revenue | 4,346 | 9,282 | 9,509 | 13,679 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 654 | 848 | 2,087 | 2,698 | ||||||||
| Research and development (1) | 5,956 | 23,876 | 24,560 | 71,738 | ||||||||
| General and administrative (1) | 5,653 | 7,091 | 17,249 | 24,198 | ||||||||
| Licensing | 1,754 | 7,344 | 4,070 | 8,955 | ||||||||
| Revaluation of contingent consideration | 800 | 1,700 | 3,800 | (600) | ||||||||
| Total costs and expenses | 14,817 | 40,859 | 51,766 | 106,989 | ||||||||
| Loss from operations | (10,471) | (31,577) | (42,257) | (93,310) | ||||||||
| Other income: | ||||||||||||
| Interest income | 1,991 | 2,316 | 5,850 | 6,320 | ||||||||
| Non-cash royalty income | 894 | - | 894 | - | ||||||||
| Total other income | 2,885 | 2,316 | 6,744 | 6,320 | ||||||||
| Net loss | $ | (7,586) | $ | (29,261) | $ | (35,513) | $ | (86,990) | ||||
| Net loss per share, basic and diluted | $ | (0.11) | $ | (0.41) | $ | (0.50) | $ | (1.25) | ||||
| Weighted average common shares outstanding, basic and diluted | 71,381,731 | 70,807,934 | 71,249,813 | 69,452,495 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 232 | $ | 347 | $ | 707 | $ | 1,119 | ||||
| Research and development | 1,124 | 3,072 | 2,192 | 9,168 | ||||||||
| General and administrative | 1,648 | 2,529 | 5,097 | 8,989 | ||||||||
| Total stock-based compensation expense | $ | 3,004 | $ | 5,948 | $ | 7,996 | $ | 19,276 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
| September 30, 2024 | December 31, 2023 | |||||
| Cash, cash equivalents and marketable securities | $ | 173,436 | $ | 181,877 | ||
| Total assets | $ | 182,394 | $ | 197,405 | ||
| Total current liabilities | $ | 18,816 | $ | 30,952 | ||
| Total liabilities | $ | 52,243 | $ | 40,226 | ||
| Total stockholders' equity | $ | 130,151 | $ | 157,179 | ||
| Common stock outstanding | 71,417,513 | 70,894,889 |
Aclaris Therapeutics, Inc.
Selected Consolidated Cash Flow Data
(unaudited, in thousands)
| Nine Months Ended | Nine Months Ended | |||||
| September 30, 2024 | September 30, 2023 | |||||
| Net loss | $ | (35,513) | $ | (86,990) | ||
| Depreciation and amortization | 664 | 635 | ||||
| Stock-based compensation expense | 7,996 | 19,276 | ||||
| Revaluation of contingent consideration | 3,800 | (600) | ||||
| Changes in operating assets and liabilities | 11,916 | (3,885) | ||||
| Net cash used in operating activities | $ | (11,137) | $ | (71,564) |
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