“It has been an exciting time for Aclaris since our IPO in October of last year as we have made significant progress with the advancement of our development pipeline. With our lead drug candidate, A-101, in the clinic for two indications (seborrheic keratosis and common warts), we look forward to seeing the results which we anticipate later this year. We also continue to expand our pipeline by adding novel compounds to our clinical program such as our JAK (Janus Kinase) inhibitor compounds for the treatment of alopecia areata and other dermatological conditions. We continue to build a commercial infrastructure and have now assembled a senior management team with over 120 combined years of directly relevant experience in dermatology,” said Dr.
Business Highlights and Recent Developments
- Initiated Phase 3 Clinical Trials of A-101 for the Treatment of Seborrheic Keratosis. Earlier this year, the company initiated two Phase 3 clinical trials to evaluate A-101 Topical Solution for the treatment of seborrheic keratosis (SK). The two Phase 3 clinical trials will evaluate the safety and efficacy of A-101 Topical Solution compared with a vehicle solution (placebo). Approximately 800 subjects will be randomized in these multi-center, double-blinded, vehicle-controlled clinical trials, which are being conducted at 34 investigational centers within
the United States . - Added to the Russell 2000® and Russell 3000® Indexes as part of Russell Investments' annual reconstitution effective as of
December 21, 2015 . - Appointed
Brett Fair as Senior Vice President of Commercial Operations. InDecember 2015 , Mr. Fair joined Aclaris, bringing more than 18 years of pharmaceutical commercialization and business development experience. - Initiated Phase 2 Clinical Trial of A-101 for Treatment of Common Warts. In
December 2015 , the company initiated a Phase 2 clinical trial to evaluate A-101 Topical Solution for the treatment of common warts (verruca vulgaris). This double-blinded, randomized Phase 2 trial, to be conducted at six sites inthe United States , will evaluate the safety, tolerability and dose-response of two concentrations of A-101 compared with a vehicle control. Aclaris intends to enroll approximately 108 subjects in this clinical trial.
Financial Highlights
Liquidity and Capital Resources
- As of
December 31, 2015 , Aclaris had aggregate cash, cash equivalents and marketable securities of$92.0 million , compared to$16.6 million as ofDecember 31 , 2014. The increase was a result of the completion of the Company’s Series C preferred stock financing in the third quarter of 2015 and the completion of the Company’s IPO in the fourth quarter of 2015, which yielded net proceeds of$39.9 million and$56.6 million , respectively. Based on our current cash position and operating plan, the Company expects that it has sufficient cash to fund operations through at least the third quarter of 2017, without giving effect to any potential business development transactions or additional financing events.
Fourth Quarter 2015 Financial Results
- Net loss attributable to common stockholders was
$4.9 million for the fourth quarter of 2015, compared to$3.3 million for the fourth quarter of 2014, and includes the accretion of convertible preferred stock to redemption value, as well as cumulative dividends on convertible preferred stock. Upon the closing of the IPO, all outstanding shares of convertible preferred stock were converted to common stock. - Total operating expenses for the fourth quarter of 2015 were
$4.8 million , compared with$2.6 million for the fourth quarter of 2014.- Research and development expenses were
$2.4 million for the fourth quarter of 2015, compared with$2.1 million for the fourth quarter of 2014. The increase was largely attributable to increased headcount, stock-based compensation expense, licensing fees and higher depreciation expense resulting from an equipment impairment charge, partially offset by a decrease in costs associated with ongoing clinical trials for A-101. - General and administrative expenses were
$2.4 million for the fourth quarter of 2015, compared with$0.5 million for the same period in 2014. The increase was primarily due to higher patent filing and prosecution costs associated with the JAK inhibitor technology, and increases in market research expenses, headcount, stock-based compensation expense, and the costs associated with being a public company.
- Research and development expenses were
Full Year 2015 Financial Results
- Net loss attributable to common stockholders was
$23.1 million for the year endedDecember 31, 2015 , compared to$10.6 million for the same period in 2014 and includes the accretion of convertible preferred stock to redemption value, as well as cumulative dividends on convertible preferred stock. Upon the closing of the IPO all outstanding shares of convertible preferred stock were converted to common stock. - Total operating expenses for the year ended
December 31, 2015 were$20.7 million , compared with$8.5 million for the year endedDecember 31, 2014 .- Research and development expenses were
$15.3 million for the year endedDecember 31, 2015 , compared with$6.5 million for the same period in 2014. The increase was driven by an$8.0 million upfront payment we made toRigel Pharmaceuticals, Inc. in connection with licensing the JAK inhibitor technology, increased headcount and stock-based compensation expense, partially offset by a decrease in costs associated with ongoing clinical trials for A-101. - General and administrative expenses were
$5.3 million for the year endedDecember 31, 2015 , compared with$2.0 million for the same period in 2014. The increase was primarily due to higher patent filing and prosecution costs associated with the JAK inhibitor technology, and increases in market research expenses, headcount, stock-based compensation expense and the costs associated with being a public company.
- Research and development expenses were
Upcoming Milestones
- We anticipate Phase 3 results for A-101 Topical Solution for the treatment of seborrheic keratosis in the third quarter of this year and, if the data is positive, our plan is to submit an NDA to the
FDA in the fourth quarter of this year. - We anticipate Phase 2 results for A-101 Topical Solution for the treatment of common warts in the third quarter of this year.
- For our JAK inhibitor program for the treatment of alopecia areata, our plan is to submit an IND in the second half of this year for A-201 and commence a proof-of-concept trial in the first half of 2017. For A-301, we are targeting the submission of an IND and commencement of clinical trials in the first half of 2017.
Company to Host Conference Call
Management will conduct a conference call at
To participate on the live call, please dial (877) 481-7177 (domestic) or (262) 558-6167 (international), and reference conference ID 50890341 prior to the start of the call.
About
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 Aclaris’ A-101 drug candidate for the treatment of seborrheic keratosis and for common warts and its JAK inhibitor drug candidates for the treatment of alopecia areata and other dermatological conditions, and our beliefs that our capital resources will be sufficient to meet our anticipated cash requirements through at least the third quarter of 2017. 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’ Quarterly Report on Form 10-Q for the quarter ended
| Aclaris Therapeutics, Inc. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,402 | 2,054 | 15,339 | 6,507 | ||||||||||||
| General and administrative | 2,400 | 548 | 5,328 | 2,026 | ||||||||||||
| Total operating expenses | 4,802 | 2,602 | 20,667 | 8,533 | ||||||||||||
| Loss from operations | (4,802 | ) | (2,602 | ) | (20,667 | ) | (8,533 | ) | ||||||||
| Interest income | 88 | 5 | 104 | 16 | ||||||||||||
| Net loss | (4,714 | ) | (2,597 | ) | (20,563 | ) | (8,517 | ) | ||||||||
| Accretion of convertible preferred stock | (213 | ) | (660 | ) | (2,566 | ) | (2,054 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (4,927 | ) | $ | (3,257 | ) | $ | (23,129 | ) | $ | (10,571 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.28 | ) | $ | (1.76 | ) | $ | (3.79 | ) | $ | (6.15 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 17,832,264 | 1,850,961 | 6,107,042 | 1,720,082 | ||||||||||||
| Aclaris Therapeutics, Inc. | ||||||||
| Selected Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| December 31, 2015 | December 31, 2014 | |||||||
| Cash, cash equivalents and investments | $ | 92,038 | $ | 16,648 | ||||
| Total assets | 94,076 | 17,377 | ||||||
| Total current liabilities | 1,555 | 1,451 | ||||||
| Total liabilities | 1,555 | 1,455 | ||||||
| Total stockholders' equity (deficit) | 92,521 | (20,755 | ) | |||||
Contact: Aclaris ContactFrank Ruffo Chief Financial Officer 484-324-7933 investors@aclaristx.com Investor ContactPatricia L. Bank Westwicke Partners Managing Director 415-513-1284 patti.bank@westwicke.com Media ContactMike Beyer Sam Brown, Inc. 312-961-2502 mikebeyer@sambrown.com