Full Press Release Details
Aclaris Therapeutics Reports Third Quarter 2020 Financial Results and Provides a Corporate Update
| First Subject Dosed in Phase 2a Trial of ATI-1777, an Investigational Topical "Soft" JAK 1/3 Inhibitor, for the Treatment of Moderate to Severe Atopic Dermatitis | |||
| Initiated Phase 2a Trial of ATI-450, an Investigational Oral MK2 Inhibitor, for the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS) |
WAYNE, Pa., November 4, 2020 (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 2020 and provided a corporate update.
"We have continued to meet our milestones and meaningfully advance our pipeline," said Dr. Neal Walker, President & CEO of Aclaris. "We recently announced that we dosed our first subject in our Phase 2a trial of ATI-1777 for the treatment of moderate to severe atopic dermatitis. In addition, we initiated our Phase 2a trial of ATI-450 as a potential treatment for cryopyrin-associated periodic syndrome, an orphan immuno-inflammatory indication. We look forward to progressing these trials as well as our ongoing trial of ATI-450 for rheumatoid arthritis."
Research and Development Highlights:
The global outbreak of COVID-19 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.
Business Development Highlights:
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2020, Aclaris had aggregate cash, cash equivalents, restricted cash and marketable securities of $55.2 million compared to $75.0 million as of December 31, 2019. For the three and nine months ended September 30, 2020, net cash used in operating activities was $12.2 million and $29.8 million, respectively. As of September 30, 2020, Aclaris had approximately 42.9 million shares of common stock outstanding.
In August 2020, Aclaris entered into an equity purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park). The agreement allows Aclaris to sell, at its discretion, up to $15.0 million of its common stock to Lincoln Park.
Aclaris anticipates that its cash, cash equivalents, restricted cash and marketable securities as of September 30, 2020 will be sufficient to fund its operations through the first quarter of 2022, without giving effect to any potential business development transactions or financing activities.
Third Quarter 2020 and Year-to-Date Financial Results
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, its plan to pursue strategic alternatives for its drug candidates and ESKATA, and its belief that its existing cash, cash equivalents, restricted cash and marketable securities will be sufficient to fund its operations through the first quarter of 2022. 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, 2019, Aclaris' Quarterly Report on Form 10-Q for the quarter ended September 30, 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 http://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, | |||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||
| Revenues: | ||||||||||||
| Contract research | $ | 1,331 | $ | 983 | $ | 4,373 | $ | 3,132 | ||||
| Other revenue | 118 | - | 529 | - | ||||||||
| Total revenue | 1,449 | 983 | 4,902 | 3,132 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 1,189 | 826 | 3,847 | 3,028 | ||||||||
| Research and development (1) | 6,866 | 16,183 | 22,775 | 53,334 | ||||||||
| General and administrative (1) | 3,859 | 6,838 | 15,632 | 21,771 | ||||||||
| Goodwill impairment | - | - | - | 18,504 | ||||||||
| Total costs and expenses | 11,914 | 23,847 | 42,254 | 96,637 | ||||||||
| Loss from operations | (10,465) | (22,864) | (37,352) | (93,505) | ||||||||
| Other expense, net | (194) | (274) | (205) | (589) | ||||||||
| Loss from continuing operations | (10,659) | (23,138) | (37,557) | (94,094) | ||||||||
| Loss from discontinued operations (1) | - | (32,181) | (285) | (48,666) | ||||||||
| Net loss | $ | (10,659) | $ | (55,319) | $ | (37,842) | $ | (142,760) | ||||
| Net loss per share, basic and diluted | $ | (0.25) | $ | (1.34) | $ | (0.90) | $ | (3.46) | ||||
| Weighted average common shares outstanding, basic and diluted | 42,802,582 | 41,364,387 | 42,187,140 | 41,296,377 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 216 | $ | 25 | $ | 728 | $ | 454 | ||||
| Research and development | 437 | 1,418 | 2,192 | 4,733 | ||||||||
| General and administrative | 1,288 | 2,581 | 5,783 | 7,707 | ||||||||
| Loss from discontinued operations | - | (704) | - | 102 | ||||||||
| Total stock-based compensation expense | $ | 1,941 | $ | 3,320 | $ | 8,703 | $ | 12,996 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| September 30, 2020 | December 31, 2019 | ||||||
| Cash, cash equivalents, restricted cash and marketable securities | $ | 55,230 | $ | 75,015 | |||
| Total assets | 71,902 | 98,297 | |||||
| Total current liabilities | 12,788 | 22,432 | |||||
| Total liabilities | 31,145 | 28,385 | |||||
| Total stockholders' equity | 40,757 | 69,912 |