Full Press Release Details
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update
- Rich Catalyst Calendar Expected in 2025 Including Phase 2 Data in Multiple Immuno-Inflammatory Disease Indications -
- Data from CTTQ's Phase 2 Studies of Bosakitug (ATI-045) in Chinese Patients with Severe Asthma and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Expected in the First Half of 2025 to Inform Internal Development Programs -
- Initiation of Enrollment in Phase 2b Trial for Bosakitug in Atopic Dermatitis (AD) on Track for the First Half of 2025 -
- Cash Runway Expected into 2028 -
WAYNE, Pa., Feb. 27, 2025 -- 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 fourth quarter and full year ended 2024 and provided a corporate update.
"2024 was a transformative year that has positioned Aclaris with multiple clinical catalysts expected in 2025 across our expanded pipeline," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "We are particularly excited about the upcoming Phase 2 data for bosakitug in both severe asthma and chronic rhinosinusitis with nasal polyps anticipated from our partner CTTQ, which we expect will provide important insights into our future development of bosakitug in respiratory diseases. We also anticipate top-line data from our Phase 2a trial of ATI-2138 in atopic dermatitis in the first half of 2025. With multiple clinical catalysts expected throughout 2025 across our pipeline of differentiated assets with mechanisms shown to have proven activity in the diseases we are addressing, we look to drive continued innovation for the patients we seek to treat."
Fourth Quarter 2024 Highlights and Recent Updates
Fourth Quarter and Full Year 2024 Financial Results
As of December 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $203.9 million compared to $181.9 million as of December 31, 2023. The Company believes that its cash, cash equivalents and marketable securities as of December 31, 2024 will be sufficient to fund its operations into 2028, without giving effect to any potential business development transactions or financing activities.
Net loss was $96.6 million for the fourth quarter of 2024 compared to $1.5 million for the fourth quarter of 2023. Net loss was $132.1 million for the year ended December 31, 2024 compared to $88.5 million for the year ended December 31, 2023.
Total revenue was $9.2 million for the fourth quarter of 2024 compared to $17.6 million for the fourth quarter of 2023. The decrease was primarily driven by a one-time upfront payment under the license agreement with Sun Pharmaceutical Industries, Inc. received in the fourth quarter of 2023, offset by the achievement of a commercial milestone under the license agreement with Eli Lilly and Company in the fourth quarter of 2024. Total revenue was $18.7 million for the year ended December 31, 2024 compared to $31.2 million for the year ended December 31, 2023.
Research and development (R&D) expenses were $9.0 million for the quarter ended December 31, 2024 compared to $26.6 million for the prior year period. The $17.6 million decrease was primarily the result of lower zunsemetinib development expenses, lepzacitinib preclinical and clinical development activities, and compensation-related expenses. For the year ended December 31, 2024, R&D expenses were $33.6 million compared to $98.4 million for the year ended December 31, 2023.
General and administrative (G&A) expenses were $5.0 million for the quarter ended December 31, 2024 compared to $8.2 million for the corresponding prior year period. The decrease was primarily due to a reduction in personnel and stock-based compensation expenses. For the year ended December 31, 2024, G&A expenses were $22.2 compared to $32.4 million for the year ended December 31, 2023, primarily due to lower compensation-related costs.
Licensing expenses were $8.6 million for the quarter ended December 31, 2024 compared to $5.7 million for the prior year period. The increase was primarily attributable to a milestone achieved during the fourth quarter of 2024, the entirety of which was payable to a third party. For the year ended December 31, 2024, licensing expenses were $12.7 million compared to $14.7 million for the year ended December 31, 2023.
Revaluation of contingent consideration resulted in a $1.3 million gain for the quarter ended December 31, 2024 compared to a $26.3 million gain for the prior year period. For the year ended December 31, 2024, revaluation of contingent consideration resulted in a charge of $2.5 million compared to a $26.9 million gain for the year ended December 31, 2023.
During the quarter and year ended December 31, 2024, the Company recorded $86.9 million of in-process research and development expenses, representing the fair value of consideration expensed in connection with the in-license of bosakitug (ATI-045) and ATI-052, as well as transaction costs incurred. During the quarter ended December 31, 2023, the Company recorded an intangible asset impairment charge of $6.6 million representing the full balance of its in-process research and development intangible asset.
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. 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, the clinical development of its product candidates, including enrolling trials, the timing of data from trials and the timing of submitting an IND for ATI-052, and the sufficiency of its cash, cash equivalents and marketable securities to fund its operations into 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.
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Aclaris Therapeutics, Inc.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenues: | ||||||||||||
| Contract research | $ | 615 | $ | 566 | $ | 2,541 | $ | 3,035 | ||||
| Licensing | 8,596 | 17,004 | 16,179 | 28,214 | ||||||||
| Total revenue | 9,211 | 17,570 | 18,720 | 31,249 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 705 | 725 | 2,792 | 3,423 | ||||||||
| Research and development (1) | 9,026 | 26,646 | 33,586 | 98,384 | ||||||||
| General and administrative (1) | 4,954 | 8,214 | 22,203 | 32,412 | ||||||||
| Licensing | 8,596 | 5,703 | 12,666 | 14,658 | ||||||||
| Revaluation of contingent consideration | (1,300) | (26,300) | 2,500 | (26,900) | ||||||||
| In-process research and development | 86,905 | 6,629 | 86,905 | 6,629 | ||||||||
| Total costs and expenses | 108,886 | 21,617 | 160,652 | 128,606 | ||||||||
| Loss from operations | (99,675) | (4,047) | (141,932) | (97,357) | ||||||||
| Other income: | ||||||||||||
| Interest income | 2,103 | 2,189 | 7,953 | 8,509 | ||||||||
| Non-cash royalty income | 1,020 | - | 1,914 | - | ||||||||
| Total other income | 3,123 | 2,189 | 9,867 | 8,509 | ||||||||
| Loss before income taxes | (96,552) | (1,858) | (132,065) | (88,848) | ||||||||
| Income tax benefit | - | (367) | - | (367) | ||||||||
| Net loss | $ | (96,552) | $ | (1,491) | $ | (132,065) | $ | (88,481) | ||||
| Net loss per share, basic and diluted | $ | (1.01) | $ | (0.02) | $ | (1.71) | $ | (1.27) | ||||
| Weighted average common shares outstanding, basic and diluted | 95,305,768 | 70,866,315 | 77,296,665 | 69,808,855 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 231 | $ | 337 | $ | 938 | $ | 1,456 | ||||
| Research and development | 943 | (2,367) | 3,135 | 6,801 | ||||||||
| General and administrative | 1,686 | 3,296 | 6,783 | 12,285 | ||||||||
| Total stock-based compensation expense | $ | 2,860 | $ | 1,266 | $ | 10,856 | $ | 20,542 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
| December 31, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and marketable securities | $ | 203,896 | $ | 181,877 | |||
| Total assets | $ | 220,327 | $ | 197,405 | |||
| Total current liabilities | $ | 31,596 | $ | 30,952 | |||
| Total liabilities | $ | 64,773 | $ | 40,226 | |||
| Total stockholders' equity | $ | 155,554 | $ | 157,179 | |||
| Common stock outstanding | 107,850,124 | 70,894,889 |
Aclaris Therapeutics, Inc.
Selected Consolidated Cash Flow Data
(unaudited, in thousands)
| Year Ended December 31, 2024 | Year Ended December 31, 2023 | ||||||
| Net loss | $ | (132,065) | $ | (88,481) | |||
| Depreciation and amortization | 807 | 863 | |||||
| Stock-based compensation expense | 10,856 | 20,542 | |||||
| Revaluation of contingent consideration | 2,500 | (26,900) | |||||
| In-process research and development expense | 86,905 | 6,629 | |||||
| Deferred taxes | - | (367) | |||||
| Changes in operating assets and liabilities | 10,922 | 9,389 | |||||
| Net cash used in operating activities | $ | (20,075) | $ | (78,325) |