Aclaris Therapeutics Reports Third Quarter 2020 Financial Results and Provides a Corporate Update
November 04 2020 - 7:00AM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage
biopharmaceutical company focused on developing novel drug
candidates for immuno-inflammatory diseases, today announced its
financial results for the third quarter of 2020 and provided a
corporate update.
“We have continued to meet our milestones and meaningfully
advance our pipeline,” said Dr. Neal Walker, President & CEO of
Aclaris. “We recently announced that we dosed our first subject in
our Phase 2a trial of ATI-1777 for the treatment of moderate to
severe atopic dermatitis. In addition, we initiated our Phase 2a
trial of ATI-450 as a potential treatment for cryopyrin-associated
periodic syndrome, an orphan immuno-inflammatory indication. We
look forward to progressing these trials as well as our ongoing
trial of ATI-450 for rheumatoid arthritis.”
Research and
Development
Highlights:The global outbreak of
COVID-19 continues to rapidly evolve and has caused and may
continue to cause Aclaris to experience disruptions that could
impact the timing of its research and development and
regulatory activities listed below.
- ATI-450, an investigational
oral small molecule MK2 inhibitor compound:
- ATI-450-RA-201: An ongoing Phase 2a clinical
trial to investigate the safety, tolerability, pharmacokinetics and
pharmacodynamics of ATI-450 in subjects with moderate to severe
rheumatoid arthritis. Aclaris’ planned enrollment for this trial is
up to 25 subjects.
- Aclaris anticipates reporting data from this trial in the first
half of 2021.
- ATI-450-CAPS-201: An ongoing
Phase 2a open-label, single-arm clinical trial to investigate the
safety, tolerability, efficacy and pharmacodynamics of ATI-450 for
the maintenance of remission in subjects with cryopyrin-associated
periodic syndrome (CAPS) previously managed with anti-IL1 therapy.
Aclaris’ planned enrollment for this trial is up to 10 subjects.
The primary endpoint of the trial is an assessment of safety and
tolerability. The key secondary efficacy endpoint of the trial is
the proportion of subjects who maintain disease remission.
- Aclaris initiated this trial and filed for orphan drug
designation for the indication in November 2020.
- IIT-2020-ATI-450-COVID-19: An ongoing
investigator-initiated Phase 2a, randomized, double-blind,
placebo-controlled clinical trial to investigate the safety and
efficacy of ATI-450, when used in addition to standard of care
therapy, as a potential treatment for cytokine release syndrome in
approximately 36 hospitalized patients with COVID-19. Aclaris is
providing funding and clinical drug supply to the University
of Kansas Medical Center (KUMC), the sponsor of the trial. The
primary endpoint in this trial is the proportion of subjects who
are free from respiratory failure by day 14.
- ATI-1777, an investigational
topical “soft” Janus Kinase (JAK) 1/3 inhibitor compound:
- ATI-1777-AD-201: An ongoing Phase 2a
multicenter, randomized, double-blind, vehicle-controlled,
parallel-group clinical trial to investigate the efficacy, safety,
tolerability and pharmacokinetics of ATI-1777 in subjects with
moderate or severe atopic dermatitis. Aclaris’ planned enrollment
for this trial is approximately 42 subjects. The primary endpoint
is the percentage change from baseline in the Eczema Area and
Severity Index (EASI) score at week 4.
- The first subject was dosed in October 2020.
- ATI-2138, an investigational
oral ITK/TXK/JAK3 (ITJ) inhibitor compound:
- Aclaris is developing ATI-2138 as a potential treatment for
psoriasis and/or inflammatory bowel disease and expects to submit
an Investigational New Drug (IND) Application for ATI-2138 in
2021.
Business Development
Highlights:
- Aclaris continues to pursue strategic alternatives, including
seeking partners for:
- A-101 45% Topical Solution: to obtain
regulatory approval and commercialize A-101 45% Topical Solution,
an investigational compound, as a potential treatment for common
warts (verruca vulgaris);
- ATI-501 & ATI-502: to further develop,
obtain regulatory approval and commercialize ATI-501 (oral) and
ATI-502 (topical), investigational JAK 1/3 inhibitor compounds, as
potential treatments for alopecia; and
- ESKATA: to commercialize ESKATA® (hydrogen
peroxide) topical solution, 40% (w/w).
Financial
Highlights:Liquidity and Capital
Resources
As of September 30, 2020, Aclaris had aggregate cash, cash
equivalents, restricted cash and marketable securities of $55.2
million compared to $75.0 million as of December 31, 2019. For the
three and nine months ended September 30, 2020, net cash used in
operating activities was $12.2 million and $29.8 million,
respectively. As of September 30, 2020, Aclaris had approximately
42.9 million shares of common stock outstanding.
In August 2020, Aclaris entered into an equity purchase
agreement with Lincoln Park Capital Fund, LLC (Lincoln Park). The
agreement allows Aclaris to sell, at its discretion, up to $15.0
million of its common stock to Lincoln Park.
Aclaris anticipates that its cash, cash equivalents, restricted
cash and marketable securities as of September 30, 2020 will be
sufficient to fund its operations through the first quarter of
2022, without giving effect to any potential business development
transactions or financing activities.
Third Quarter 2020 and Year-to-Date Financial
Results
- The accompanying condensed
consolidated statements of operations and selected consolidated
balance sheet data have been recast for all periods presented to
reflect the assets, liabilities, revenue and expenses related to
Aclaris’ commercial products as discontinued operations.
- Net loss was $10.7 million for the
third quarter of 2020 compared to $55.3 million for the third
quarter of 2019, and was $37.8 million for the nine months ended
September 30, 2020 compared to $142.8 million for the nine months
ended September 30, 2019.
- Total revenue was $1.4 million for
the third quarter of 2020 compared to $1.0 million for the third
quarter of 2019, and was $4.9 million for the nine months ended
September 30, 2020 compared to $3.1 million for the nine months
ended September 30, 2019.
- Research and development (R&D)
expenses were $6.9 million for the quarter ended September 30, 2020
compared to $16.2 million for the prior year period, and were $22.8
million for the nine months ended September 30, 2020 compared to
$53.3 million for the prior year period.
- The quarter-over-quarter decrease of
$9.3 million was primarily the result of the substantial completion
of Aclaris’ various Phase 2 clinical trials of ATI-501 and ATI-502
and two pivotal Phase 3 clinical trials of A-101 45% Topical
Solution in 2019, and the corresponding reduction in personnel
costs to support these programs. Additionally, Aclaris made a $4.0
million milestone payment for the achievement of a development
milestone in the third quarter of 2019 which also contributed to
the decrease quarter-over-quarter.
- R&D expenses in the third
quarter of 2020 included non-cash stock-based compensation expense
of $0.4 million compared to $1.4 million in the prior year
period.
- General and administrative (G&A)
expenses were $3.9 million for the quarter ended September 30, 2020
compared to $6.8 million for the prior year period, and were $15.6
million for the nine months ended September 30, 2020 compared to
$21.8 million for the prior year period.
- The quarter-over-quarter decrease of
$3.0 million was primarily the result of lower personnel costs
resulting from Aclaris’ decision to discontinue commercial
operations in September 2019.
- G&A expenses in the third
quarter of 2020 included non-cash stock-based compensation expense
of $1.3 million compared to $2.6 million in the prior year
period.
- Loss from continuing operations was
$10.7 million for the quarter ended September 30, 2020 compared to
$23.1 million for the prior year period, and was $37.6 million for
the nine months ended September 30, 2020 compared to $94.1 million
for the prior year period. Loss from discontinued operations was $0
for the third quarter of 2020 compared to $32.2 million for the
third quarter of 2019, and was $0.3 million for the nine months
ended September 30, 2020 compared to $48.7 million for the nine
months ended September 30, 2019.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing a pipeline of novel drug candidates to address the needs
of patients with immuno-inflammatory diseases who lack satisfactory
treatment options. The company has a multi-stage portfolio of drug
candidates powered by a robust R&D engine exploring protein
kinase regulation. For additional information, please visit
www.aclaristx.com.
Cautionary Note Regarding Forward-Looking
StatementsAny 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,” “intend,” “may,”
“plan,” “potential,” “will,” and similar expressions, and are based
on Aclaris' current beliefs and expectations. These forward-looking
statements include expectations regarding the clinical development
of Aclaris’ drug candidates, including the availability of data
from its clinical trials and timing for regulatory filings, its
plan to pursue strategic alternatives for its drug candidates and
ESKATA, and its belief that its existing cash, cash equivalents,
restricted cash and marketable securities will be sufficient to
fund its operations through the first quarter of 2022. 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, Aclaris’ ability to enter into
strategic partnerships on commercially reasonable terms, the
uncertainty regarding the COVID-19 pandemic 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,
2019, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended
September 30, 2020, and other filings Aclaris makes with the U.S.
Securities and Exchange Commission from time to time. These
documents are available under the “SEC filings” page of the
Investors section 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.Condensed Consolidated
Statements of Operations(unaudited, in thousands, except share and
per share data) |
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
1,331 |
|
|
$ |
983 |
|
|
$ |
4,373 |
|
|
$ |
3,132 |
|
Other revenue |
|
|
118 |
|
|
|
— |
|
|
|
529 |
|
|
|
— |
|
Total revenue |
|
|
1,449 |
|
|
|
983 |
|
|
|
4,902 |
|
|
|
3,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
1,189 |
|
|
|
826 |
|
|
|
3,847 |
|
|
|
3,028 |
|
Research and development (1) |
|
|
6,866 |
|
|
|
16,183 |
|
|
|
22,775 |
|
|
|
53,334 |
|
General and administrative (1) |
|
|
3,859 |
|
|
|
6,838 |
|
|
|
15,632 |
|
|
|
21,771 |
|
Goodwill impairment |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
18,504 |
|
Total costs and expenses |
|
|
11,914 |
|
|
|
23,847 |
|
|
|
42,254 |
|
|
|
96,637 |
|
Loss from operations |
|
|
(10,465 |
) |
|
|
(22,864 |
) |
|
|
(37,352 |
) |
|
|
(93,505 |
) |
Other expense, net |
|
|
(194 |
) |
|
|
(274 |
) |
|
|
(205 |
) |
|
|
(589 |
) |
Loss from continuing
operations |
|
|
(10,659 |
) |
|
|
(23,138 |
) |
|
|
(37,557 |
) |
|
|
(94,094 |
) |
Loss from discontinued
operations (1) |
|
|
— |
|
|
|
(32,181 |
) |
|
|
(285 |
) |
|
|
(48,666 |
) |
Net loss |
|
$ |
(10,659 |
) |
|
$ |
(55,319 |
) |
|
$ |
(37,842 |
) |
|
$ |
(142,760 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.25 |
) |
|
$ |
(1.34 |
) |
|
$ |
(0.90 |
) |
|
$ |
(3.46 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
42,802,582 |
|
|
|
41,364,387 |
|
|
|
42,187,140 |
|
|
|
41,296,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
216 |
|
|
$ |
25 |
|
|
$ |
728 |
|
|
$ |
454 |
|
Research and development |
|
|
437 |
|
|
|
1,418 |
|
|
|
2,192 |
|
|
|
4,733 |
|
General and
administrative |
|
|
1,288 |
|
|
|
2,581 |
|
|
|
5,783 |
|
|
|
7,707 |
|
Loss from discontinued
operations |
|
|
— |
|
|
|
(704 |
) |
|
|
— |
|
|
|
102 |
|
Total stock-based compensation
expense |
|
$ |
1,941 |
|
|
$ |
3,320 |
|
|
$ |
8,703 |
|
|
$ |
12,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics, Inc.Selected Consolidated
Balance Sheet Data(unaudited, in thousands) |
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
Cash, cash equivalents,
restricted cash and marketable securities |
|
$ |
55,230 |
|
$ |
75,015 |
Total assets |
|
|
71,902 |
|
|
98,297 |
Total current liabilities |
|
|
12,788 |
|
|
22,432 |
Total liabilities |
|
|
31,145 |
|
|
28,385 |
Total stockholders'
equity |
|
|
40,757 |
|
|
69,912 |
|
|
|
|
|
|
|
Aclaris
Contactinvestors@aclaristx.com
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