Full Press Release Details
Aclaris Therapeutics Reports Second Quarter 2024 Financial Results and Provides a Corporate Update
-Initiated Phase 2a Study Activities for ATI-2138 in Atopic Dermatitis-
-Strengthened Balance Sheet Through Sale of Future OLUMIANT Royalties for Proceeds of up to $31.5 Million-
WAYNE, Pa., Aug. 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 second quarter of 2024 and provided a corporate update.
"With study activities underway for our ATI-2138 Phase 2a trial in moderate to severe atopic dermatitis and the strengthening of our balance sheet through the completion of our royalty purchase agreement with OMERS, we're well-positioned to drive our strategic initiatives forward," said Dr. Neal Walker, Interim President & CEO and Chair of the Board of Directors of Aclaris. "Our focus remains on leveraging our resources to maximize the potential of our innovative drug candidates, pursue available opportunities, and create long-term value for patients and shareholders alike."
Research and Development Highlights:
ITK Inhibitor Programs
Financial Highlights:
Liquidity and Capital Resources
As of June 30, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $149.9 million compared to $181.9 million as of December 31, 2023. In July 2024, Aclaris received an upfront payment of $26.5 million and is eligible to receive up to an additional $5.0 million upon the achievement of certain sales milestones in connection with the sale of OLUMIANT royalties and milestones to OMERS Life Sciences.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of June 30, 2024 in combination with the $26.5 million from the sale of OLUMIANT royalties and milestones will be sufficient to fund its operations into 2028, without giving effect to any potential new business development transactions, additional financing activities or the outcome of its strategic review.
OLUMIANT is a registered trademark of Eli Lilly and Company.
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, 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 plans and 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 | Six Months Ended | |||||||||||
| June 30, | June 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenues: | ||||||||||||
| Contract research | $ | 625 | $ | 875 | $ | 1,281 | $ | 1,764 | ||||
| Licensing | 2,141 | 994 | 3,882 | 2,633 | ||||||||
| Total revenue | 2,766 | 1,869 | 5,163 | 4,397 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 624 | 1,042 | 1,433 | 1,850 | ||||||||
| Research and development (1) | 8,759 | 25,275 | 18,604 | 47,862 | ||||||||
| General and administrative (1) | 4,752 | 8,317 | 11,596 | 17,107 | ||||||||
| Licensing | 1,285 | 550 | 2,316 | 1,611 | ||||||||
| Revaluation of contingent consideration | 200 | (1,500) | 3,000 | (2,300) | ||||||||
| Total costs and expenses | 15,620 | 33,684 | 36,949 | 66,130 | ||||||||
| Loss from operations | (12,854) | (31,815) | (31,786) | (61,733) | ||||||||
| Other income, net | 1,868 | 2,246 | 3,859 | 4,004 | ||||||||
| Net loss | $ | (10,986) | $ | (29,569) | $ | (27,927) | $ | (57,729) | ||||
| Net loss per share, basic and diluted | $ | (0.15) | $ | (0.42) | $ | (0.39) | $ | (0.84) | ||||
| Weighted average common shares outstanding, basic and diluted | 71,291,400 | 70,633,528 | 71,183,129 | 68,763,542 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 223 | $ | 473 | $ | 475 | $ | 772 | ||||
| Research and development | 1,097 | 3,494 | 1,068 | 6,096 | ||||||||
| General and administrative | 1,583 | 2,555 | 3,449 | 6,460 | ||||||||
| Total stock-based compensation expense | $ | 2,903 | $ | 6,522 | $ | 4,992 | $ | 13,328 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
| June 30, 2024 | December 31, 2023 | |||||
| Cash, cash equivalents and marketable securities | $ | 149,871 | $ | 181,877 | ||
| Total assets | $ | 161,071 | $ | 197,405 | ||
| Total current liabilities | $ | 15,682 | $ | 30,952 | ||
| Total liabilities | $ | 27,249 | $ | 40,226 | ||
| Total stockholders' equity | $ | 133,822 | $ | 157,179 | ||
| Common stock outstanding | 71,332,825 | 70,894,889 |
Aclaris Therapeutics, Inc.
Selected Consolidated Cash Flow Data
(unaudited, in thousands)
| Six Months Ended | Six Months Ended | |||||
| June 30, 2024 | June 30, 2023 | |||||
| Net loss | $ | (27,927) | $ | (57,729) | ||
| Depreciation and amortization | 485 | 416 | ||||
| Stock-based compensation expense | 4,992 | 13,328 | ||||
| Revaluation of contingent consideration | 3,000 | (2,300) | ||||
| Changes in operating assets and liabilities | (13,687) | (722) | ||||
| Net cash used in operating activities | $ | (33,137) | $ | (47,007) |
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