Full Press Release Details
Aclaris Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update
-- Provides Update on Clinical and Other Developments
-- Initiates Financial Guidance for Full Year 2017
-- Management to Host Conference Call at 8:00 a.m. ET today
Malvern, PA March 15, 2017 (GLOBE NEWSWIRE) Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biotechnology company, today announced financial results for the fourth quarter and year ended December 31, 2016 and provided an update on its clinical development programs.
The year was a transformational year as we continued to make progress toward our goal of becoming a fully integrated biotechnology company. In November 2016, we reported that two pivotal Phase 3 trials of our lead product candidate A-101 40% Topical Solution met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of seborrheic keratosis (SK) lesions. In February 2017, we submitted a New Drug Application (NDA) for A-101 40% Topical Solution for the treatment of SK to the U.S. Food and Drug Administration (FDA), said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. During 2016 we also reported positive data from a Phase 2 trial of A-101 45% Topical Solution for the treatment of common warts. Finally, we recently completed a Phase 1 clinical trial of ATI-50001, our investigational Janus Kinase (JAK) inhibitor, for the treatment of alopecia totalis and alopecia universalis.
Clinical Pipeline Update
Business Highlights and Recent Developments
2017 Financial Outlook
Financial Highlights
Liquidity and Capital Resources
Fourth Quarter 2016 Financial Results
Full Year 2016 Financial Results
Company to Host Conference Call
Management will conduct a conference call at 8:00 a.m. ET today to discuss Aclaris' financial results and provide a general business update. The conference 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 62366728 prior to the start of the call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a dermatologist-led biotechnology company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology. Aclaris is based in Malvern, Pennsylvania.
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", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding Aclaris' use of cash and research and development and total operating expenses during 2017, development programs in skin and hair conditions, and the clinical development of JAK inhibitors. 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, 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, 2016 and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "Financial Information" 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
(in thousands, except share and per share data)
| Three Months Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 2016 | 2015 | 2016 | 2015 | |||||
| Revenue | $ - | $ - | $ - | $ - | ||||
| Operating expenses: | ||||||||
| Research and development (1) | 6,943 | 2,402 | 33,476 | 15,339 | ||||
| General and administrative (1) | 4,684 | 2,400 | 15,091 | 5,328 | ||||
| Total operating expenses | 11,627 | 4,802 | 48,567 | 20,667 | ||||
| Loss from operations | (11,627) | (4,802) | (48,567) | (20,667) | ||||
| Other income, net | 152 | 88 | 488 | 104 | ||||
| Net loss | (11,475) | (4,714) | (48,079) | (20,563) | ||||
| Accretion of convertible preferred stock | (213) | - | (2,566) | |||||
| Net loss attributable to common stockholders | $ (11,475) | $ (4,927) | $ (48,079) | $ (23,129) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ (0.49) | $ (0.28) | $ (2.25) | $ (3.79) | ||||
| Weighted average common shares outstanding, basic and diluted | 23,390,746 | 17,832,264 | 21,415,733 | 6,107,042 | ||||
| (1) Amounts include stock-based compensation expense as follows: | ||||||||
| Research and development | $ 714 | $ 183 | $ 2,291 | $ 257 | ||||
| General and administrative | 1,196 | 464 | 3,813 | 634 | ||||
| Total stock-based compensation expense | $ 1,910 | $ 647 | $ 6,104 | $ 891 |
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
| December 31, 2016 | December 31, 2015 | ||||||
| Cash, cash equivalents and investments | $ | 174,134 | $ | 92,038 | |||
| Total assets | 176,085 | 94,076 | |||||
| Total current liabilities | 6,223 | 1,555 | |||||
| Total liabilities | 6,595 | 1,555 | |||||
| Total stockholders' equity | 169,490 | 92,521 |
Vice President / Investor Relations