Full Press Release Details
Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update
- Topline Data from Zunsemetinib Phase 2b Trial in Rheumatoid Arthritis Expected this Month -
- Completion of Enrollment in ATI-1777 Phase 2b Trial in Atopic Dermatitis As Previously Announced; Topline Data Anticipated Around Year-End 2023 -
WAYNE, Pa., Nov. 06, 2023 (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 2023 and provided a corporate update.
"Throughout the first three quarters of this year, I believe our company has performed remarkably well in terms of executing across our clinical development programs," stated Doug Manion, M.D., Chief Executive Officer of Aclaris. "Most importantly, we are rapidly approaching the topline data read-outs for our two most advanced clinical programs, zunsemetinib in rheumatoid arthritis this month and ATI-1777 in atopic dermatitis around the end of this year. This level of high-quality execution is further exemplified as we advance ATI-2138 in patients with ulcerative colitis, and we're pleased to collaborate with Washington University as they advance ATI-2231 in patients with advanced solid tumor malignancies."
Research and Development Highlights:
Currently being developed as a potential treatment for immuno-inflammatory diseases
Currently being developed as a potential treatment for mild to severe atopic dermatitis (AD)
Currently being developed as a potential treatment for ulcerative colitis; Aclaris is also exploring additional indications for other T cell-mediated autoimmune diseases
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer. Aclaris is also currently exploring options to use ATI-2231 as a potential treatment for immuno-inflammatory diseases
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2023, Aclaris had aggregate cash, cash equivalents and marketable securities of $187.0 million compared to $229.8 million as of December 31, 2022.
Aclaris continues to anticipate that its cash, cash equivalents and marketable securities as of September 30, 2023 will be sufficient to fund its operations through the end of 2025, without giving effect to any potential business development transactions or financing activities.
exclusive patent license agreement with Eli Lilly and Company (Lilly) received in the third quarter of 2022.
uncertain as a result of their filing for Chapter 11 bankruptcy protection also contributed to the increase.
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 the development of Aclaris' drug candidates, including the timing of its clinical trials, availability of data from those trials, and regulatory filings, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations through the end of 2025. 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, 2022, 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, | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Revenues: | ||||||||||||
| Contract research | $ | 705 | $ | 1,090 | $ | 2,469 | $ | 3,529 | ||||
| Licensing | 8,577 | 17,898 | 11,210 | 18,378 | ||||||||
| Other | - | 30 | - | 92 | ||||||||
| Total revenue | 9,282 | 19,018 | 13,679 | 21,999 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 848 | 923 | 2,698 | 3,146 | ||||||||
| Research and development (1) | 23,876 | 23,656 | 71,738 | 56,741 | ||||||||
| General and administrative (1) | 7,091 | 5,813 | 24,198 | 17,987 | ||||||||
| Licensing | 7,344 | 7,300 | 8,955 | 7,300 | ||||||||
| Revaluation of contingent consideration | 1,700 | 2,200 | (600) | (2,400) | ||||||||
| Total costs and expenses | 40,859 | 39,892 | 106,989 | 82,774 | ||||||||
| Loss from operations | (31,577) | (20,874) | (93,310) | (60,775) | ||||||||
| Other income, net | 2,316 | 922 | 6,320 | 1,502 | ||||||||
| Net loss | $ | (29,261) | $ | (19,952) | $ | (86,990) | $ | (59,273) | ||||
| Net loss per share, basic and diluted | $ | (0.41) | $ | (0.30) | $ | (1.25) | $ | (0.92) | ||||
| Weighted average common shares outstanding, basic and diluted | 70,807,934 | 66,675,337 | 69,452,495 | 64,718,008 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 347 | $ | 307 | $ | 1,119 | $ | 837 | ||||
| Research and development | 3,072 | 1,400 | 9,168 | 2,228 | ||||||||
| General and administrative | 2,529 | 2,481 | 8,989 | 7,161 | ||||||||
| Total stock-based compensation expense | $ | 5,948 | $ | 4,188 | $ | 19,276 | $ | 10,226 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
| September 30, 2023 | December 31, 2022 | |||||
| Cash, cash equivalents and marketable securities | $ | 186,996 | $ | 229,813 | ||
| Total assets | $ | 218,354 | $ | 254,596 | ||
| Total current liabilities | $ | 27,320 | $ | 21,938 | ||
| Total liabilities | $ | 62,021 | $ | 56,975 | ||
| Total stockholders' equity | $ | 156,333 | $ | 197,621 | ||
| Common stock outstanding | 70,818,954 | 66,688,647 |
Aclaris Therapeutics, Inc.
Selected Consolidated Cash Flow Data
(unaudited, in thousands)
| Nine Months Ended September 30, 2023 | Nine Months Ended September 30, 2022 | |||||
| Net loss | $ | (86,990) | $ | (59,273) | ||
| Depreciation and amortization | 635 | 607 | ||||
| Stock-based compensation expense | 19,276 | 10,226 | ||||
| Revaluation of contingent consideration | (600) | (2,400) | ||||
| Changes in operating assets and liabilities | (3,885) | 2,388 | ||||
| Net cash used in operating activities | $ | (71,564) | $ | (48,452) |
Aclaris Therapeutics Contact:
Vice President, Investor Relations