Aclaris Therapeutics Reports Third Quarter 2017 Financial Results
November 07 2017 - 7:00AM
Management to Host Conference Call at
8:00 AM ET today
Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led
biopharmaceutical company focused on identifying, developing, and
commercializing innovative and differentiated therapies to address
significant unmet needs in medical and aesthetic dermatology, today
announced financial results for the third quarter of 2017 and
provided an update on its clinical development
programs.
“The third quarter of 2017 has been a productive one for
Aclaris. In August, we closed the acquisition of Confluence Life
Sciences, Inc. (“Confluence”), and we continue to prepare for our
December 24th PDUFA date for A-101 40% Topical Solution for the
treatment of seborrheic keratosis,” said Dr. Neal Walker, President
and Chief Executive Officer of Aclaris.
Clinical Pipeline Update
- A-101 40% Topical Solution • In
September, published results from a Phase 2 clinical trial
evaluating two concentrations (40% and 32.5%) of its drug candidate
A-101 for the treatment of facial seborrheic keratosis (SK) lesions
in the journal Dermatologic Surgery. In the trial, A-101 achieved
statistically significant improvement in clearing SK lesions on the
face in a dose-related fashion. A-101 was well tolerated at both
concentrations studied. • The FDA’s Prescription Drug User Fee
Act (PDUFA) action date for the New Drug Application (NDA) is
December 24, 2017. If approved, A-101 40% Topical Solution would be
the first FDA-approved medication for SK.
- A-101 45% Topical Solution • In June,
initiated two Phase 2 clinical trials of A-101 45% Topical Solution
(A-101 45%) for the treatment of common warts. The Phase 2 clinical
trials are designed to evaluate the safety, tolerability and dose
frequency of A-101 45% compared with placebo in adult and pediatric
patients. • Enrollment in both phase 2 trials has been
completed and 316 patients have been enrolled in the two
double-blinded trials which are being conducted at 34
investigational centers within the United States. Aclaris expects
to report data from these two trials in the first half of
2018.
- JAK Inhibitors • In October, initiated a
Phase 2 clinical trial of ATI-50002, a topical Janus Kinase (JAK)
1/3 inhibitor (ATI-50002 Topical) for the treatment of alopecia
areata (AA). This trial will evaluate the pharmacokinetics,
pharmacodynamics and safety of ATI-50002 Topical compared with
placebo in 12 patients with AA. This randomized, double-blind
clinical trial is being conducted at two investigational centers
within the United States, and data is expected to be available in
the first half of 2018. • In November, initiated a Phase
2 open-label clinical trial of ATI-50002 Topical for the treatment
of AA. This trial will evaluate the effect of ATI-50002 Topical on
the regrowth of eyebrows in up to 24 patients with AA. This trial
is being conducted at two investigational centers in Sydney and
Melbourne, Australia, and data is also expected to be available in
the first half of 2018. • Continue plans to initiate a
Phase 2 dose ranging trial of ATI-50002 Topical for the treatment
of AA next week. This study is a randomized, double-blinded,
parallel-group, vehicle controlled trial and plan to enroll
approximately 120 patients at 20 investigational centers within the
United States. Data is expected to be available by year end
2018. • Continue plans to initiate a Phase 2 open-label
clinical trial of ATI-50002 Topical for the treatment of vitiligo
by the end of 2017. • Now plan to initiate a Phase 2 dose
ranging trial of ATI-50001, an oral JAK inhibitor, for the
treatment of AA in the first half of 2018. • Continue to
develop another series of topical JAK inhibitors for the treatment
of androgenetic alopecia (AGA).
Business Highlights and Recent Developments
- In August, completed the acquisition of Confluence, a privately
held biotechnology company focused on the discovery and development
of kinase inhibitors to treat inflammatory and immunological
disorders and cancer.
- In August, raised net proceeds of $80.9 million from a
follow-on offering of our common stock.
- In September, the United States Patent and Trademark Office
(USPTO) issued U.S. Patent No. 9,737,469 and U.S. Patent No.
9,730,877, and the Japan Patent Office issued Japanese Letters
Patent No. 6212107. These patents are directed to methods related
to the use and administration of certain JAK inhibitors for
treating hair loss disorders. These newly issued patents are owned
by The Trustees of Columbia University in the City of New York and
exclusively licensed to Aclaris. • U.S. Patent No. 9,730,877
covers the use of various JAK inhibitors, including tofacitinib,
baricitinib, ruxolitinib and decernotinib, to treat AGA, also known
as male/female pattern hair loss. The ‘877 Patent contains 22
claims and expires in November 2031. • U.S. Patent No.
9,737,469 covers the use of baricitinib for inducing hair growth
and for treating hair loss disorders such as AA and AGA.
Additional issued claims pertain to methods of using baricitinib to
treat particular phenotypes of AA, as well as to treat other hair
loss disorders. The ‘469 Patent contains 10 claims and expires in
November 2031. • Japanese Letters Patent No. 6212107 covers
the use of tofacitinib in a topical composition or as the sole
active therapeutic agent in a pharmaceutical composition for
inducing hair growth and for treating hair loss disorders, such as
AA and AGA. The ‘107 patent issued with 25 claims and expires in
March 2033.
- In October, Columbia University received a Notice of Allowance
from the USPTO for a patent application covering methods of
treating a hair-loss disorder, such as AA and AGA, or inducing hair
growth, by administering tofacitinib topically or by administering
tofacitinib as the sole active ingredient, and treating AGA or
inducing hair growth in a subject having AGA by administering
tofacitinib. The application was allowed with 66 claims.
- In October, hosted inaugural R&D and Investor Day
event.
Financial Highlights
Liquidity and Capital Resources
- As of September 30, 2017, Aclaris had aggregate cash, cash
equivalents and marketable securities of $227.8 million compared to
$174.1 million as of December 31, 2016. The $53.7 million
increase during the nine months ended September 30, 2017
included: • Aggregate net proceeds of $100.2 million from the
public offering of common stock in August 2017 and the sale of
common stock under an at-the-market facility with Cowen in May
2017. • $9.6 million of cash used to acquire Confluence, net
of cash acquired. • Net loss of $45.6 million and $1.2
million of net cash used in working capital, partially offset by
$10.4 million of non-cash stock-based compensation expense,
depreciation and amortization.
- Aclaris anticipates that its cash, cash equivalents and
marketable securities as of September 30, 2017 will be sufficient
to fund its operations into the second half of 2019, without giving
effect to any potential new business development transactions or
financing activities.
Third Quarter 2017 Financial Results
- Net loss was $18.2 million for the third quarter of 2017,
compared to $10.7 million for the third quarter of 2016.
- Revenue of $0.7 million and cost of revenue of $0.5 million for
the third quarter of 2017 related to Confluence’s contract research
organization (CRO) business acquired in August 2017.
- Total operating expenses for the third quarter of 2017 were
$19.0 million, compared to $10.8 million for the third quarter of
2016. • Research and development expenses were $10.9 million
for the third quarter of 2017, compared to $7.2 million for the
third quarter of 2016. The increase of $3.7 million was primarily
attributable to a $1.2 million increase in expenses related to the
Phase 2 clinical trials of A-101 45%, a $1.3 million increase in
personnel-related expenses, including stock-based compensation, due
to increased headcount, a $0.9 million increase in preclinical and
clinical trial development expenses related to the JAK inhibitor
technology and a $0.9 million increase in medical affairs expenses
and other costs, including early stage drug discovery, offset in
part by a $1.2 million decrease in clinical costs for A-101 40%
Topical Solution resulting from the completion of Phase 3 clinical
trials in November 2016. • General and administrative
expenses were $8.1 million for the third quarter of 2017, compared
to $3.7 million for the third quarter of 2016. The increase of $4.4
million was primarily attributable to $1.9 million in higher
personnel-related expenses, including stock-based compensation, due
to increased headcount, and $0.4 million in expenses related to the
acquisition of Confluence. Additionally, Aclaris had a $1.6 million
increase in market research and sales operations expenses related
to pre-commercial activities for A-101 40% Topical
Solution.
- As of September 30, 2017, Aclaris had approximately 30.8
million shares of common stock outstanding.
2017 Financial Outlook
Aclaris is updating its estimates for the
following financial metrics for the full year 2017, which estimates
now incorporate the acquisition of Confluence:
- Cash burn for 2017, excluding this year’s financing activities
and cash paid in the Confluence acquisition, is now estimated to be
in the range of $56 million to $59 million compared to previous
guidance of $65 million to $70 million.
- Total operating expenses for 2017 are now estimated to be in
the range of $72 million to $75 million, or $57 million to $60
million when excluding estimated stock-based compensation expense
of $15 million. Prior guidance for operating expenses was $84
million to $92 million, or $70 million to $75 million when
excluding stock-based compensation of $14 to $17
million.
- Research and development expenses for 2017 are now estimated to
be in the range of $39 million to $42 million, or $33 million to
$36 million when excluding estimated stock-based compensation
expense of $6 million. Prior guidance for research and development
expenses was $51 million to $58 million, or $46 million to $52
million when excluding stock-based compensation of $5 million to $6
million.
Company to Host Conference Call
Management will conduct a conference call at 8:00 AM 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
99295180 prior to the start of the call.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a dermatologist-led biopharmaceutical company
focused on identifying, developing and commercializing innovative
and differentiated therapies to address significant unmet needs in
medical and aesthetic dermatology. Aclaris is focused on
large, underserved market segments with no FDA-approved medications
or where treatment gaps exist. 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
its research and development and total operating expenses during
2017 and the clinical development of its product candidates,
including the availability of data from its ongoing and planned
clinical trials and timing for initiation of planned clinical
trials, and its belief that its existing capital resources will be
sufficient to fund its operations into the second half of 2019.
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, Aclaris’ Quarterly Report on Form 10-Q to be filed for the
quarter ended September 30, 2017, 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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
Revenue |
|
$ |
684 |
|
|
$ |
- |
|
|
$ |
684 |
|
|
$ |
- |
|
Cost of revenue |
|
|
453 |
|
|
|
‑ |
|
|
|
453 |
|
|
|
‑ |
|
Gross
profit |
|
|
231 |
|
|
|
‑ |
|
|
|
231 |
|
|
|
‑ |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development (1) |
|
|
10,864 |
|
|
|
7,162 |
|
|
|
26,601 |
|
|
|
26,533 |
|
General and
administrative (1) |
|
|
8,123 |
|
|
|
3,650 |
|
|
|
20,611 |
|
|
|
10,407 |
|
Total operating
expenses |
|
|
18,987 |
|
|
|
10,812 |
|
|
|
47,212 |
|
|
|
36,940 |
|
Loss from
operations |
|
|
(18,756) |
|
|
|
(10,812) |
|
|
|
(46,981) |
|
|
|
(36,940) |
|
Other income,
net |
|
|
564 |
|
|
|
118 |
|
|
|
1,392 |
|
|
|
336 |
|
Net loss |
|
$ |
(18,192) |
|
|
$ |
(10,694) |
|
|
$ |
(45,589) |
|
|
$ |
(36,604) |
|
Net loss
per share, basic and diluted |
$ |
(0.63) |
|
|
$ |
(0.50) |
|
|
$ |
(1.68) |
|
|
$ |
(1.76) |
|
Weighted
average common shares outstanding, basic and diluted |
|
28,834,808 |
|
|
|
21,415,871 |
|
|
|
27,180,244 |
|
|
|
20,752,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts
include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenue |
$ |
130 |
|
|
$ |
‑ |
|
|
$ |
130 |
|
|
$ |
‑ |
|
Research
and development |
|
1,332 |
|
|
|
623 |
|
|
|
3,853 |
|
|
|
1,577 |
|
General and
administrative |
|
2,211 |
|
|
|
995 |
|
|
|
6,147 |
|
|
|
2,617 |
|
Total
stock-based compensation expense |
$ |
3,673 |
|
|
$ |
1,618 |
|
|
$ |
10,130 |
|
|
$ |
4,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and marketable securities |
|
$ |
227,848 |
|
$ |
174,134 |
|
Total assets |
|
|
261,391 |
|
|
176,085 |
|
Total current
liabilities |
|
|
9,993 |
|
|
6,223 |
|
Total liabilities |
|
|
17,132 |
|
|
6,595 |
|
Total stockholders'
equity |
|
|
244,259 |
|
|
169,490 |
|
|
|
|
|
|
|
|
|
Contact:
Aclaris ContactMichael Tung, M.D. Vice President / Investor
Relations484-329-2140mtung@aclaristx.com
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