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 March 15,  2017, “Aclaris Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update”

ACLARIS THERAPEUTICS, INC.

By:  

/s/ Frank Ruffo

Date:  March 15, 2017

Frank Ruffo
Chief Financial Officer

Exhibit

Number

Exhibit Description

99.1

Press Release, dated March 15,  2017, “Aclaris Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update”

·

A-101 40% Topical Solution

o

In November 2016, reported positive data from two pivotal Phase 3 trials, SEBK-301 and SEBK-302, in which A-101 40% Topical Solution achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.  SEBK-301 and SEBK-302 enrolled 937 patients in total and were conducted at 34 investigational centers in the United States.

o

There were no treatment-related serious adverse events among patients treated with A-101 40% Topical Solution, and local skin reactions (LSR), if present, were predominantly classified as mild.  The rates of hypopigmentation, hyperpigmentation, and scarring classified as greater than mild were less than one percent in all groups in both trials

o

In February 2017, submitted an NDA to the FDA for A-101 40% Topical Solution as a treatment for SK.  

o

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

·

A-101 45% Topical Solution

o

In August 2016, reported positive data from a Phase 2 trial, WART-201, in which A-101 45% Topical Solution achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.  WART-201 enrolled 98 patients in total and was conducted at six investigational centers in the United States.

o

A-101 45% Topical Solution was well-tolerated and LSRs were primarily mild in severity and similar to placebo. The most frequently reported LSR across treatment groups was mild erythema.

o

Completed an FDA teleconference and plan to initiate two Phase  2 clinical trials of A-101 45% Topical Solution for the treatment of warts in mid-2017.

·

JAK Inhibitor

o

In October 2016, we submitted an Investigational New Drug Application (IND) to the FDA for ATI-50001 for the treatment of alopecia totalis and alopecia universalis and recently completed a Phase 1 clinical trial.

o

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

Plan to submit IND for ATI-50002 for the topical treatment of patchy alopecia areata mid-2017.

o

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

o

Aclaris has exclusively licensed several patents and patent applications involving novel selective JAK 1/3 inhibitors, including a patent portfolio from Rigel Pharmaceuticals, Inc. that covers ATI-50001 as well as ATI-50002, a topical formulation also being developed as a potential treatment for alopecia areata.  In addition, Aclaris has exclusively licensed a patent portfolio from JAKPharm and Key Organics directed to novel covalently binding, highly selective JAK 3 inhibitors.  Finally, Aclaris has exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of alopecia areata, androgenetic alopecia, and other dermatological conditions.  This portfolio includes a recently issued U.S. patent directed to methods of treating alopecia areata, androgenetic alopecia and other hair loss disorders by administering ruxolitinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib or other JAK inhibitors for use in treating alopecia areata, androgenetic alopecia and other hair loss disorders.

·

During 2016, raised approximately $117 million in net proceeds from the sale of our common stock.

·

Continued to build out research and development and commercial infrastructure.

·

Appointed Andrew Powell to the Board of Directors – Andrew has more than 27 of experience years in the biotechnology and pharmaceutical industry.  He most recently served as Senior Vice President, General Counsel and Corporate Secretary of Medivation, Inc. from May 2015 until its acquisition by Pfizer, Inc. in November 2016. Prior to Medivation, Mr. Powell served in executive leadership roles at InterMune, Inc., where he played a leadership role in InterMune’s acquisition by Roche Holdings AG, ImClone Systems, Inc., where he helped the company grow before playing a key role in its sale to Eli Lilly, Collagenex Pharmaceuticals, Inc., where he was part of a senior team that repositioned the company as a leader in dermatology before its acquisition by Galderma Pharma S.A., and Baxter International, Inc.,   where he was instrumental in a series of transactions that established Baxter throughout Asia.

·

Appointed Bill Humphries to the Board of Directors – Bill is the Executive Vice President, Group Chairman Dermatology of Valeant Pharmaceuticals.  Previously, Bill was President and Chief Executive Officer of Merz, Inc. (affiliate of Merz Pharma Group), North American business and was a member of the Merz Pharma Board and the Chairman of the Merz, Inc. Board of Directors.  At Merz, Inc., Bill was responsible for the continued and accelerated growth of the Aesthetics, Dermatology, OTC/OTX and Neuroscience businesses within North America. Bill has more than 29 years of experience in the specialty pharmaceutical industry, with more than 26 of those years focused on the commercialization of products in medical dermatology and aesthetics.

·

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

·

Aclaris estimates 2017 total operating expenses 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.  

·

Aclaris anticipates 2017 research and development expenses 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.  

·

As of December 31, 2016, Aclaris had aggregate cash, cash equivalents and marketable securities of $174.1 million, compared to $92.0 million as of December 31, 2015.  The $82.1 million increase during the year ended December 31, 2016 included: 

·

Net cash from financing activities of $18.5 million in net proceeds received from a private placement financing completed in June 2016 and $98.2 million in net proceeds received from a follow-on offering completed in November 2016.

·

Net cash used in operations of $34.6 million during the year ended December 31, 2016. This amount was composed of a net loss of $48.1 million, less non-cash operating expenses of $2.8 million for the acquisition of Vixen Pharmaceuticals, Inc., and $6.1 million in stock-based compensation expense, as well as $4.5 million in net cash increases in working capital. 

·

Aclaris presently anticipates that its cash, cash equivalents and marketable securities as of December 31, 2016 will be sufficient to fund its operations through at least the end of 2018, without giving effect to potential new business development transactions or financing activities.

·

Net loss attributable to common stockholders was $11.5 million for the fourth quarter of 2016, compared to $4.9 million for the fourth quarter of 2015. 

·

Total operating expenses for the fourth quarter of 2016 were $11.6 million, compared to $4.8 million for the fourth quarter of 2015. 

o

Research and development expenses were $6.9 million for the fourth  quarter of 2016, compared to $2.4 million for the fourth quarter of 2015. The increase of $4.5 million was primarily due to a $2.2 million increase in direct costs associated with the preclinical development expenses related to the JAK inhibitor technology, a $1.4 million increase in the clinical development of A-101, and a $1.1 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount.

o

General and administrative expenses were $4.7 million for the fourth  quarter of 2016, compared to $2.4 million for the fourth quarter of 2015. The increase of $2.3 million was primarily attributable to increases of $1.4 million in personnel-related expenses, including stock-based compensation, due to increased headcount, and $0.8 million in market research costs related to pre-commercial activities for A-101 40% Topical Solution.  

·

Net loss attributable to common stockholders was $48.1 million for the year ended December 31, 2016, compared to $23.1 million for the year ended December 31, 2015. 

·

Total operating expenses were $48.6 million for the year ended December 31, 2016, compared to $20.7 million for the year ended December 31, 2015. 

o

Research and development expenses were $33.5 million for the year ended December 31, 2016, compared to $15.3 million for the prior year. The increase of $18.2 million was primarily due to a $7.3 million increase in direct costs associated with the preclinical development

expenses related to the JAK inhibitor technology, a $10.8 million increase in the clinical development of A-101, and a $4.2 million increase in personnel-related expenses, including stock-based compensation, due to increased headcount.    The increases noted above were partially offset by a decrease of $4.6 million in licensing expenses as Aclaris incurred $3.4 million of expenses associated with the Vixen acquisition in the year ended December 31, 2016, compared to $8.0 million of expenses for the upfront payment made to a third party during the year ended December 31, 2015.    

o

General and administrative expenses were $15.1 million for the year ended December 31, 2016, compared to $5.3 million for the prior year. The increase of $9.8 million was primarily attributable to increases of $5.4 million in personnel-related expenses, including stock-based compensation, due to increased headcount, $1.5 million in professional fees associated with being a public company, and  $1.5 million in market research costs related to pre-commercial activities for A-101 40% Topical Solution.

Three Months Ended

Year Ended

December  31,

December  31,

2016

2015

2016

2015

Revenue

$                   -  

$                -  

$              -  

 $             -  

Operating expenses:

Research and development (1)

General and administrative (1)

Total operating expenses

Loss from operations

Other income, net

Net loss

Accretion of convertible preferred stock

‑ 

       -

Net loss attributable to common stockholders

 $   (23,129)

Net loss per share attributable to common stockholders, basic and diluted

Weighted average common shares outstanding, basic and diluted

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

Research and development

General and administrative

Total stock-based compensation expense

December  31, 2016

December 31, 2015

Cash, cash equivalents and investments

$

$

Total assets

Total current liabilities

Total liabilities

Total stockholders' equity