Full Press Release Details
Aclaris Therapeutics Reports Third Quarter 2021 Financial Results and Provides a Corporate Update
| Investigational New Drug Application for ATI-2138 for the Treatment of Psoriasis Submitted in October 2021 | ||
| Planning to Initiate Phase 2b Trial of Zunsemetinib (ATI-450) in Moderate to Severe Rheumatoid Arthritis in the Fourth Quarter of 2021 |
WAYNE, Pa., Nov. 02, 2021 (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 2021 and provided a corporate update.
"This quarter we are pleased to announce the submission of an investigational new drug application for ATI-2138, our investigational oral ITK/TXK/JAK3 inhibitor, the third novel clinical candidate generated by our proprietary KINect drug discovery platform," said Dr. Neal Walker, President & CEO of Aclaris. "If allowed, we plan to progress ATI-2138 into a Phase 1 trial. We also continue to make progress toward initiating a Phase 2b trial of zunsemetinib (ATI-450) in moderate to severe rheumatoid arthritis and Phase 2 trials of zunsemetinib in psoriatic arthritis and moderate to severe hidradenitis suppurativa, as well as our Phase 2b trial of ATI-1777 in moderate to severe atopic dermatitis."
Research and Development Highlights:
The global COVID-19 pandemic continues to rapidly evolve and has caused and may continue to cause Aclaris to experience disruptions that could impact the timing of its research and development and regulatory activities listed below.
Zunsemetinib has been adopted as the nonproprietary name for ATI-450.
Aclaris plans to progress zunsemetinib into a Phase 2b trial in moderate to severe rheumatoid arthritis in the fourth quarter of 2021.
Aclaris also plans to progress zunsemetinib into Phase 2 trials in psoriatic arthritis and moderate to severe hidradenitis suppurativa.
In pre-clinical studies, positive effects on MK2 inhibition have been observed for breast cancer metastasis and cancer-associated bone loss.
"Soft" JAK Inhibitor Asset
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $243.6 million compared to $54.1 million as of December 31, 2020. The primary factors for the change in cash, cash equivalents and marketable securities during the nine months ended September 30, 2021 included:
Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2021 will be sufficient to fund its operations through the end of 2024, without giving effect to any potential business development transactions or financing activities.
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 "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 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 2024. 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 COVID-19 pandemic 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, 2020, 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, | ||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||
| Revenues: | |||||||||||||
| Contract research | $ | 1,415 | $ | 1,331 | $ | 4,556 | $ | 4,373 | |||||
| Other revenue | 244 | 118 | 704 | 529 | |||||||||
| Total revenue | 1,659 | 1,449 | 5,260 | 4,902 | |||||||||
| Costs and expenses: | |||||||||||||
| Cost of revenue (1) | 1,099 | 1,189 | 3,564 | 3,847 | |||||||||
| Research and development (1) | 13,976 | 6,240 | 29,711 | 20,382 | |||||||||
| General and administrative (1) | 5,979 | 3,859 | 16,676 | 15,632 | |||||||||
| Revaluation of contingent consideration | 900 | 626 | 22,139 | 2,393 | |||||||||
| Total costs and expenses | 21,954 | 11,914 | 72,090 | 42,254 | |||||||||
| Loss from operations | (20,295) | (10,465) | (66,830) | (37,352) | |||||||||
| Other expense, net | (851) | (194) | (1,231) | (205) | |||||||||
| Loss from continuing operations | (21,146) | (10,659) | (68,061) | (37,557) | |||||||||
| Loss from discontinued operations | - | - | - | (285) | |||||||||
| Net loss | $ | (21,146) | $ | (10,659) | $ | (68,061) | $ | (37,842) | |||||
| Net loss per share, basic and diluted | $ | (0.35) | $ | (0.25) | $ | (1.23) | $ | (0.90) | |||||
| Weighted average common shares outstanding, basic and diluted | 61,219,321 | 42,802,582 | 55,215,037 | 42,187,140 |
(1) Amounts include stock-based compensation expense as follows:
| Cost of revenue | $ | 206 | $ | 216 | $ | 787 | $ | 728 | |||||
| Research and development | 939 | 437 | 2,969 | 2,192 | |||||||||
| General and administrative | 2,557 | 1,288 | 6,453 | 5,783 | |||||||||
| Total stock-based compensation expense | $ | 3,702 | $ | 1,941 | $ | 10,209 | $ | 8,703 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
| September 30, 2021 | December 31, 2020 | ||||||
| Cash, cash equivalents and marketable securities | $ | 243,617 | $ | 54,131 | |||
| Total assets | $ | 263,494 | $ | 70,784 | |||
| Total current liabilities | $ | 17,839 | $ | 14,874 | |||
| Total liabilities | $ | 46,913 | $ | 33,134 | |||
| Total stockholders' equity | $ | 216,581 | $ | 37,650 | |||
| Common stock outstanding | 61,226,750 | 45,109,314 |