MALVERN, Pa., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage specialty pharmaceutical company, today announced financial results for the third quarter and nine months ended September 30, 2016 and provided an update on its clinical development programs.
“During the third quarter we continued to advance our pipeline programs across a broad range of dermatological diseases. We reported positive results from the Wart-201 Phase 2 study and are planning the next clinical development steps. The company recently submitted an investigational new drug application (IND) for our drug candidate ATI-50001 for the oral treatment of alopecia totalis and alopecia universalis. We also look forward to reporting the results from our Phase 3 clinical trials for our lead drug candidate A-101 Topical Solution (A-101) for the treatment of seborrheic keratosis (SK) in the coming weeks,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris.
WART-201 was a randomized, double-blind, vehicle-controlled clinical trial designed to evaluate the safety and dose-response of 40% and 45% concentrations of A-101, compared with placebo (vehicle) in patients with common warts. Ninety-eight patients were enrolled in the study at six investigational centers within the United States. The primary endpoint of the trial was the mean change from baseline in the Physician’s Wart Assessment (PWA) score one week after the last of eight weekly treatments. Secondary endpoints included the proportion of patients whose target wart was judged to be clear on the PWA scale and the proportion of patients whose target wart was judged to be either clear or barely evident on the PWA scale. Of the 98 patients enrolled, 90 completed the 8-week treatment period.
Business Highlights and Recent Developments
Liquidity and Capital Resources
Third Quarter 2016 Financial Results
Company to Host Conference Call
Management will conduct a conference call at 8:30 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 97609147 prior to the start of the call.
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. Aclaris Therapeutics, Inc. is based in Malvern, Pennsylvania and more information can be found by visiting the company’s website at 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”, “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 A-101 for the treatment of SK and for common warts and the development of ATI-50001, ATI-50002, and other JAK inhibitor compounds for other dermatological conditions. 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 Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2015, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and other filings Aclaris makes with the SEC 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||Nine Months Ended|
|September 30,||September 30,|
|Research and development||7,162||9,407||26,533||12,937|
|General and administrative||3,650||1,233||10,407||2,928|
|Total operating expenses||10,812||10,640||36,940||15,865|
|Loss from operations||(10,812||)||(10,640||)||(36,940||)||(15,865||)|
|Other income, net||118||8||336||16|
|Accretion of convertible preferred stock||‑||(1,020||)||-||(2,353||)|
|Net loss attributable to common stockholders||$||(10,694||)||$||(11,652||)||$||(36,604||)||$||(18,202||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.50||)||$||(5.12||)||$||(1.76||)||$||(8.44||)|
|Weighted average common shares outstanding, basic and diluted||21,415,871||2,274,617||20,752,590||2,155,685|
|Aclaris Therapeutics, Inc.|
|Selected Consolidated Balance Sheet Data|
|September 30, 2016||December 31, 2015|
|Cash, cash equivalents and marketable securities||$||84,042||$||92,038|
|Total current liabilities||4,591||1,555|
|Total stockholders' equity||81,122||92,521|
Last updated on: 03/11/2016
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