OREANDA-NEWS. Aclaris Therapeutics, Inc., a clinical-stage specialty pharmaceutical company, today announced financial results for the second quarter and six months ended June 30, 2016 and provided an update on its clinical development programs.

“We are pleased with our progress on several fronts as we continue along the path of becoming a fully integrated dermatology company.  We recently completed the enrollment of multiple trials for our lead drug candidate A-101 Topical Solution (A-101) and, in addition, we completed a private placement equity financing, from which we raised net proceeds of $18.5 million,” commented Dr. Neal Walker, President and Chief Executive Officer of Aclaris.  “With our initiation of preclinical development in vitiligo and androgenetic alopecia (AGA), commonly referred to as female or male pattern baldness, we now have a diverse pipeline targeting multiple dermatological conditions.  We look forward to the second half of 2016, during which we expect to report results from multiple clinical trials,” added Dr. Walker.

Business Highlights and Recent Developments

  • Completed patient enrollment in two Phase 3 pivotal clinical trials and a Phase 3 open-label safety trial of A-101 for the treatment of seborrheic keratosis (SK).  Also completed the enrollment of a Phase 2 clinical trial of two concentrations of A-101 (40% and 45%) for the treatment of common warts (verruca vulgaris).
  • Closed a private placement of 1,081,082 shares of common stock at a purchase price of $18.50 per share, yielding net proceeds of $18.5 million.  The private placement was led by Aisling Capital with participation by additional new and existing investors.
  • Commenced preclinical development of Aclaris’ Janus Kinase (JAK) inhibitor compounds for vitiligo and AGA.
  • Engaged TogoRun, a global health and wellness strategic communications firm, to support corporate branding, SK awareness initiatives and drug development milestone announcements.  TogoRun team members have an impressive track record of building successful aesthetic brands and driving the rapid growth of the medical aesthetics field.
  • Continued to expand management team with the hiring of Kimberley Forbes-McKean, Ph.D as Senior Vice President of Drug Development and Michael Tung, M.D. as Vice President of Investor Relations.

Financial Highlights

Liquidity and Capital Resources

  • As of June 30, 2016, Aclaris had aggregate cash, cash equivalents and marketable securities of $94.0 million, compared to $92.0 million as of December 31, 2015.  The $2.0 million increase during the six months ended June 30, 2016 included:
    • $18.5 million of net proceeds received from a private placement financing completed in June 2016.
    • Net cash used in operations of $16.6 million during the six months ended June 30, 2016. This amount was composed of a net loss of $25.9 million, less non-cash operating expenses of $2.8 million for the acquisition of Vixen Pharmaceuticals, Inc. (Vixen), $2.6 million in stock-based compensation expense and $3.9 million in net cash from changes in working capital.
  • Aclaris presently anticipates that its cash, cash equivalents and marketable securities balances as of June 30, 2016 will be sufficient to fund its operations through at least the fourth quarter of 2017, without giving effect to potential new business development transactions or financing activities.

 Second Quarter 2016 Financial Results

  • Net loss attributable to common stockholders was $12.9 million for the second quarter of 2016, compared to $3.3 million for the second quarter of 2015.
  • Total operating expenses for the second quarter of 2016 were $13.0 million, compared to $2.6 million for the second quarter of 2015.
    • Research and development expenses were $9.8 million for the second quarter of 2016, compared to $1.8 million for the second quarter of 2015. The increase of $8.0 million was primarily attributable to a $5.1 million increase in direct costs associated with the clinical development of A-101, a $1.6 million increase in preclinical development expenses related to the JAK inhibitor technology, and a $1.1 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount.
    • General and administrative expenses were $3.2 million for the second quarter of 2016, compared to $0.8 million for the second quarter of 2015. The increase of $2.4 million was primarily attributable to increases of $1.3 million in personnel-related expenses, including stock-based compensation, due to increased headcount, $0.6 million in professional fees associated with being a public company, and $0.3 million in market research costs related to the A-101 program.

Upcoming Milestones

  • Aclaris expects to report Phase 2 initial results for A-101 for the treatment of common warts in the third quarter of this year.
  • Aclaris expects to report Phase 3 initial results for A-101 for the treatment of SK in the fourth quarter of this year. If the data is positive, Aclaris plans to submit a new drug application (NDA) to the FDA in the first quarter of 2017 and a marketing authorization application (MAA) to the EMA in mid-2017.
  • Aclaris plans to submit an IND in the second half of this year for ATI-50001, and commence clinical trials in the first half of 2017 for the oral treatment of alopecia totalis and alopecia universalis.
  • Aclaris plans to submit an IND and commence clinical trials for ATI-50002 in the first half of 2017 for the topical treatment of patchy alopecia areata.
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.