Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biotechnology company, today announced financial results for the
first quarter of 2017 and provided an update on its clinical
development programs.
“The start of 2017 has been a busy one for Aclaris and we are
pleased the momentum from last year has continued into the first
quarter of this year,” commented Dr. Neal Walker, President and
Chief Executive Officer of Aclaris. “Our New Drug Application (NDA)
for A-101 40% Topical Solution (A-101 40%) for the treatment of
seborrheic keratosis (SK) was accepted for review by the U.S. Food
and Drug Administration (FDA). We continue to advance our pipeline
and broaden our intellectual property estate as we focus our
efforts on developing innovative treatments for patients.”
Clinical Pipeline Update
• A-101 40% Topical Solution
- The NDA for A-101 40% for the topical treatment of SK has been
accepted by the FDA for review.
- The NDA contains data from three Phase 3 trials that included
more than 1,000 patients.
- 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
- 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
- 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.
- 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.
- 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.
- Finally, Aclaris is developing another series of topical JAK
inhibitors for the treatment of androgenetic alopecia (AGA).
Business Highlights and Recent Developments
• 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.
Financial Highlights
Liquidity and Capital Resources
• 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 stock. As a result
of this latest financing, Aclaris estimates that its cash, cash
equivalents and marketable securities will fund its current
operations through the first quarter of 2019.
First Quarter 2017 Financial Results
• 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.
- 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.
- 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.
2017 Financial Outlook
Aclaris reiterates the following financial
guidance:
- 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.
- 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.
- 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.
Company to Host Conference CallManagement will
conduct a conference call at 4:30 PM 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 5101760 prior to the start of the call.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a dermatologist-led biotechnology company
focused on identifying, developing and commercializing innovative
and differentiated therapies to address significant unmet needs in
medical and aesthetic dermatology. Aclaris is based in Malvern,
Pennsylvania and more information can be found by visiting the
Aclaris 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 Aclaris’ use of cash and
research and development and total operating expenses during 2017,
development programs in skin and hair conditions, the clinical
development of JAK inhibitors and the broadening of Aclaris’
intellectual property estate. 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' Annual Report on Form 10-K for
the year ended December 31, 2016, and other filings Aclaris makes
with the U.S. Securities and Exchange Commission 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 |
|
|
|
March 31, |
|
|
|
|
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 |
|
|
|
(12,930 |
) |
|
|
(13,139 |
) |
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 |
|
|
1,936 |
|
|
|
801 |
|
Total
stock-based compensation expense |
|
$ |
3,153 |
|
|
$ |
1,222 |
|
Aclaris Therapeutics, Inc.Selected
Consolidated Balance Sheet Data(in thousands) |
|
|
|
March 31, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and investments |
|
$ |
161,437 |
|
$ |
174,134 |
|
Total assets |
|
|
166,210 |
|
|
176,085 |
|
Total current
liabilities |
|
|
5,637 |
|
|
6,223 |
|
Total liabilities |
|
|
5,921 |
|
|
6,595 |
|
Total stockholders'
equity |
|
|
160,289 |
|
|
169,490 |
|
Contact:
Aclaris Contact
Michael Tung, M.D.
Vice President / Investor Relations
484-329-2140
mtung@aclaristx.com
Media Contact
Mariann Caprino
TogoRun
917-242-1087
M.Caprino@togorun.com
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