Full Press Release Details
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides R&D and Business Highlights
| Positive Preliminary Results from Phase 1 Single and Multiple Ascending Dose Trial of ATI-450, an Investigational Oral MK2 Inhibitor | |||
| Projected Cash Runway into the Third Quarter of 2021 | |||
| Management to Host Conference Call at 5:00 PM ET today |
Wayne, PA February 25, 2020 (GLOBE NEWSWIRE) Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced its financial results for the fourth quarter and full year 2019 and provided research and development (R&D) and business highlights.
In 2019, we repositioned the company to focus on our core competency in developing small molecule kinase inhibitors. Thus far, we are very pleased with the progression of our immuno-inflammatory pipeline, as well as with the positive results from our Phase 1 clinical trial of ATI-450, an oral small molecule MK2 inhibitor, said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. We look forward to initiating a Phase 2a trial of ATI-450 in subjects with rheumatoid arthritis in the first half of this year and executing on our new business plan.
Corporate Highlights:
Business Development Highlights:
Financial Highlights:
Liquidity and Capital Resources
As of December 31, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $75.0 million compared to $168.0 million as of December 31, 2018. For the quarter and year ended December 31, 2019, net cash used in operating activities was $20.4 million and $96.4 million, respectively. As of December 31, 2019, Aclaris had no long-term debt outstanding and had approximately 41.5 million shares of common stock outstanding.
Aclaris anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential business development transactions or financing activities.
Fourth Quarter 2019 and Year-to-Date Financial Results
Company to Host Conference Call
Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris' financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the Investors page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.
To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 9958112 prior to the start of the call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a physician-led biopharmaceutical company committed to addressing 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 and follow Aclaris on LinkedIn or Twitter @aclaristx.
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, timing for initiation of clinical trials and timing for regulatory filings, its plan to pursue strategic alternatives for its drug candidates and for ESKATA, and its belief that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operations into the third quarter of 2021. 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 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 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 section of the Investors page 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.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||
| Revenues: | ||||||||||||
| Product sales, net | $ | $ | $ | $ | ||||||||
| Contract research | 1,095 | 1,272 | 4,227 | 4,651 | ||||||||
| Other revenue | 500 | 1,500 | ||||||||||
| Total revenue, net | 1,095 | 1,772 | 4,227 | 6,151 | ||||||||
| Costs and expenses: | ||||||||||||
| Cost of revenue (1) | 1,028 | 1,266 | 4,055 | 4,329 | ||||||||
| Research and development (1) | 11,540 | 19,022 | 64,899 | 60,841 | ||||||||
| Sales and marketing (1) | 44 | 82 | 671 | 170 | ||||||||
| General and administrative (1) | 5,765 | 6,561 | 27,156 | 25,591 | ||||||||
| Goodwill impairment | 18,504 | |||||||||||
| Amortization of definite-lived intangible | ||||||||||||
| Total costs and expenses | 18,377 | 26,931 | 115,285 | 90,931 | ||||||||
| Loss from operations | (17,282) | (25,159) | (111,058) | (84,780) | ||||||||
| Other (expense) income, net | (1,895) | 487 | (2,484) | 2,676 | ||||||||
| Loss from continuing operations | (19,177) | (24,672) | (113,542) | (82,104) | ||||||||
| Gain / (loss) from discontinued operations (1) | 583 | (13,879) | (47,812) | (50,634) | ||||||||
| Net loss | $ | (18,594) | $ | (38,551) | $ | (161,354) | $ | (132,738) | ||||
| Net loss per share, basic and diluted | $ | (0.45) | $ | (0.99) | $ | (3.90) | $ | (4.03) | ||||
| Weighted average common shares outstanding, basic and diluted | 41,405,657 | 38,760,676 | 41,323,921 | 32,909,762 | ||||||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||||||
| Cost of revenue | $ | 249 | $ | 206 | $ | 703 | $ | 766 | ||||
| Research and development | 358 | 1,564 | 5,091 | 6,480 | ||||||||
| Sales and marketing | ||||||||||||
| General and administrative | 2,581 | 2,381 | 10,288 | 9,317 | ||||||||
| Gain / (loss) from discontinued operations | (7) | 805 | 95 | 3,492 | ||||||||
| Total stock-based compensation expense | $ | 3,181 | $ | 4,956 | $ | 16,177 | $ | 20,055 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
| December 31, 2019 | December 31, 2018 | ||||||
| Cash, cash equivalents and marketable securities | $ | 75,015 | $ | 167,972 | |||
| Total assets | 98,297 | 275,566 | |||||
| Total current liabilities | 22,432 | 27,342 | |||||
| Total liabilities | 28,385 | 60,442 | |||||
| Total stockholders' equity | 69,912 | 215,124 |
Corporate Strategy / Investor Relations