Full Press Release Details
Aclaris Therapeutics Reports First Quarter 2021 Financial Results and Provides a Corporate Update
| Data from Phase 2a Trial of ATI-1777 for Moderate to Severe Atopic Dermatitis Expected in Second Quarter of 2021 | |||
| Advancing ATI-450 with Planned Initiation of Phase 2b Trial for Moderate to Severe Rheumatoid Arthritis in Second Half of 2021 | |||
| Advancing ATI-450 into Two Additional Indications: Hidradenitis Suppurativa and Psoriatic Arthritis | |||
| Expands Scientific Advisory Board |
WAYNE, Pa., May 7, 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 first quarter of 2021 and provided a corporate update.
"We're very pleased with the progress of our novel immuno-inflammatory drug development pipeline and look forward to reporting data from our Phase 2a trial of ATI-1777 in the second quarter of 2021," said Dr. Neal Walker, President & CEO of Aclaris. "ATI-1777 is our second development program generated by KINect, our proprietary drug discovery platform. After generating proof of mechanism in inhibiting TNF , IL1 and IL6 in our Phase 2a trial of ATI-450 in moderate to severe rheumatoid arthritis, we are planning to move ATI-450 forward with a Phase 2b trial in moderate to severe rheumatoid arthritis in the second half of 2021 and planning to initiate two additional trials of ATI-450 in hidradenitis suppurativa and psoriatic arthritis."
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.
Aclaris is also expanding its Scientific Advisory Board with the addition of Dr. Philip Mease. Dr. Mease, a rheumatologist, currently serves as a Director of the Division of Rheumatology Clinical Research at the Swedish Medical Center/Providence St. Joseph Health and is a Clinical Professor at the University of Washington in Seattle. His major clinical and research focus is psoriatic arthritis and axial spondyloarthritis.
Financial Highlights:
Liquidity and Capital Resources
As of March 31, 2021, Aclaris had aggregate cash, cash equivalents and marketable securities of $142.7 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 three months ended March 31, 2021 included:
Aclaris anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021 will be sufficient to fund its operations through the end of 2023, including estimated costs for the Phase 2b trial of ATI-450 for moderate to severe rheumatoid arthritis and the planned expansion of its Phase 2 immuno-inflammatory clinical development programs for hidradenitis suppurativa and psoriatic arthritis, 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 clinical development of Aclaris' drug candidates, including the availability of data from its clinical trials and timing for 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 2023. 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 | ||||||
| March 31, | ||||||
| 2021 | 2020 | |||||
| Revenues: | ||||||
| Contract research | $ | 1,535 | $ | 1,189 | ||
| Other revenue | 242 | 218 | ||||
| Total revenue | 1,777 | 1,407 | ||||
| Costs and expenses: | ||||||
| Cost of revenue (1) | 1,202 | 1,269 | ||||
| Research and development (1) | 7,838 | 7,677 | ||||
| General and administrative (1) | 4,827 | 6,200 | ||||
| Revaluation of contingent consideration | 16,439 | 1,767 | ||||
| Total costs and expenses | 30,306 | 16,913 | ||||
| Loss from operations | (28,529) | (15,506) | ||||
| Other income (expense), net | (225) | 178 | ||||
| Loss from continuing operations | (28,754) | (15,328) | ||||
| Loss from discontinued operations | - | (258) | ||||
| Net loss | $ | (28,754) | $ | (15,586) | ||
| Net loss per share, basic and diluted | $ | (0.57) | $ | (0.37) | ||
| Weighted average common shares outstanding, basic and diluted | 50,337,807 | 41,618,429 | ||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||
| Cost of revenue | $ | 247 | $ | 260 | ||
| Research and development | 876 | 816 | ||||
| General and administrative | 1,552 | 2,377 | ||||
| Total stock-based compensation expense | $ | 2,675 | $ | 3,453 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands, except share data)
| March 31, 2021 | December 31, 2020 | ||||||
| Cash, cash equivalents and marketable securities | $ | 142,657 | $ | 54,131 | |||
| Total assets | $ | 161,399 | $ | 70,784 | |||
| Total current liabilities | $ | 14,505 | $ | 14,874 | |||
| Total liabilities | $ | 49,105 | $ | 33,134 | |||
| Total stockholders' equity | $ | 112,294 | $ | 37,650 | |||
| Common stock outstanding | 52,081,729 | 45,109,314 |