Delaware

001-37581

46-0571712

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

Exhibit

Number

Exhibit Description

99.1

Press Release, dated May 9, 2017, “Aclaris Therapeutics Reports First Quarter 2017 Financial Results”

ACLARIS THERAPEUTICS, INC.

By:  

/s/ Frank Ruffo

Date:  May 9, 2017

Frank Ruffo
Chief Financial Officer

Exhibit

Number

Exhibit Description

99.1

Press Release, dated May 9, 2017, “Aclaris Therapeutics Reports First Quarter 2017 Financial Results”

·

A-101 40% Topical Solution

o

The NDA for A-101 40% for the topical treatment of SK has been accepted by the FDA for review.

o

The NDA contains data from three Phase 3 trials that included more than 1,000 patients.

o

Plan to submit a marketing authorization application (MAA) for A-101 40% for the treatment of SK in the European Union in the second half of 2017.

·

A-101 45% Topical Solution

o

Plan to initiate two Phase 2 clinical trials of A-101 45% Topical Solution (A-101 45%) for the treatment of common warts in mid-2017.

·

JAK Inhibitor

o

Recently completed a Phase 1 clinical trial of ATI-50001, an investigational oral Janus Kinase (JAK) 1/3 inhibitor. This Phase 1 cross-over trial was conducted in 12 healthy volunteers at one investigational center in the United States to assess safety, bioavailability, and pharmacodynamics.

o

In the Phase 1 trial, treatment with ATI-50001 capsules was well tolerated. No clinically significant laboratory abnormalities were observed. These data are consistent with results from an earlier Phase 1 clinical trial in 44 healthy volunteers conducted by Rigel Pharmaceuticals in which the study drug was well tolerated at all doses.

§

Plan to initiate a Phase 2 dose ranging trial with ATI-50001 for the oral treatment of alopecia totalis and alopecia universalis in the second half of 2017.

o

In addition, Aclaris also plans to develop an investigational topical JAK 1/3 inhibitor, known as ATI-50002, for the treatment of AA and vitiligo.

§

Plan to submit an Investigational New Drug application (IND) for ATI-50002 for the topical treatment of patchy AA in mid-2017.

§

Plan to initiate a Phase 2 dose ranging trial of ATI-50002 for the topical treatment of patchy AA in the second half of 2017.

§

Plan to initiate a Phase 2 trial of ATI-50002 for the topical treatment of vitiligo in the second half of 2017. 

o

Finally, Aclaris is developing another series of topical JAK inhibitors for the treatment of androgenetic alopecia (AGA).

·

In April, Aclaris received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application covering the formulation and methods of use of A-101 40% and A-101 45%. This newly allowed patent application contains 70 allowed claims and expires in 2035.

·

In April, Columbia University received a Notice of Allowance from the USPTO for two patent applications covering methods related to the use and administration of baricitinib (LY3009104) and decernotinib (VX-509), respectively, for the treatment of hair loss disorders and for inducing hair growth. These newly allowed patent applications are owned by Columbia University and exclusively licensed to Aclaris. These patent applications are the latest U.S. applications to be allowed in connection with Aclaris' JAK drug development program for hair loss disorders.

·

In April, Aclaris raised an additional $19.4 million in net proceeds from sales of its common stock under its at-the-market sales agreement with Cowen. With these additional funds, Aclaris estimates that its cash, cash equivalents and marketable securities will fund its current operations through the first quarter of 2019.

·

In April, Aclaris hosted a symposium on JAK Inhibitors at the 76th Annual Society for Investigative Dermatology Meeting titled “You Don’t Know JAK,” with over 700 attendees. 

·

As of March 31, 2017, Aclaris had aggregate cash, cash equivalents and marketable securities of $161.4 million, compared to $174.1 million as of December 31, 2016.  The $12.7 million decrease during the three months ended March 31, 2017 included  a net loss of $12.6 million, less $3.2 million in non-cash stock-based compensation expense, plus $3.3 million of net cash used in working capital.

·

In April, Aclaris raised an additional $19.4 million in net proceeds from sales of our common stock. As a result of this latest financing, we estimate that our cash, cash equivalents and marketable securities will fund our current operations through the first quarter of 2019. 

·

Net loss was $12.6 million for the first quarter of 2017, compared to $13.0 million for the first quarter of 2016. 

·

Total operating expenses for the first quarter of 2017 were $12.9 million, compared to $13.1 million for the first quarter of 2016. 

o

Research and development expenses decreased $1.8 million to $7.8 million for the first quarter of 2017, compared to $9.5 million for the first quarter of 2016. The decrease was primarily due to a $3.4 million expense incurred related to the Vixen acquisition and a $1.8 million decrease in spending for the A-101 development program during the first quarter of 2016 offset by increased  expenditures in the first quarter of 2017 of:

·

$1.1 million for pre-clinical development expenses related to the JAK inhibitor program;

·

$1.3 million for personnel-related expenses, including stock-based compensation, due to increased headcount; and

·

$1.0 million for medical affairs activities.

o

General and administrative expenses increased $1.6 million to $5.2 million during the first quarter of 2017, compared to $3.6 million for the first quarter of 2016. The increase was primarily attributable to increases of $1.5 million in personnel-related expenses, including stock-based compensation, due to increased headcount, $0.4 million in market research costs related to pre-commercial activities for A-101 40%, partially offset by a  $0.3 million milestone payment related to A-101 40% which was incurred in the first quarter of 2016.  

o

Net cash burn for 2017 estimated to be in the range of $65 million to $70 million not including financing activities and potential acquisitions of complementary businesses or technologies.

o

Total operating expenses for 2017 estimated to be in the range of $84 million to $92 million, or $70 million to $75 million when excluding estimated stock-based compensation expense of $14 million to $17 million.

o

Research and development expenses for 2017 estimated to be in the range of $51 million to $58 million, or $46 million to $52 million when excluding estimated stock-based compensation expense of $5 million to $6 million.

Three Months Ended

Three Months Ended

December 31,

March 31,

2017

2016

2017

2016

Revenue

$                 -  

$               -  

$                -  

$              -  

Operating expenses:

 Research and development (1)

7,772

9,535

 General and administrative (1)

5,158

3,604

Total operating expenses

12,930

13,139

Loss from operations

Other income, net

371 

100

Net loss

$  

$  (12,559)

$  (13,039)

Net loss per share, basic and diluted

$      

$    

$       (0.48)

$      (0.65)

Weighted average common shares outstanding, basic and diluted

26,080,806

20,171,518

(1) Amounts include stock-based compensation expense as follows:

Research and development

$         

$       

$     1,217

$     421

General and administrative

Total stock-based compensation expense

$     

$       

$     3,153

$    1,222

March 31, 2017

December 31, 2016

Cash, cash equivalents and investments

$

$

Total assets

Total current liabilities

Total liabilities

Total stockholders' equity