Aclaris Therapeutics Reports First Quarter 2020 Financial Results and Provides R&D and Business Highlights
May 07 2020 - 4:01PM
Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led
biopharmaceutical company focused on immuno-inflammatory diseases,
today announced its financial results for the first quarter of 2020
and provided research and development (R&D) and business
highlights.
“In the first quarter, we borrowed $11 million from Silicon
Valley Bank enabling us to extend our cash runway, and
started enrolling subjects with moderate-to-severe
rheumatoid arthritis in our Phase 2a trial of ATI-450. As a
result of the COVID-19 pandemic and as a precautionary measure, we
temporarily paused subject enrollment in this trial. At this
time, we have decided to resume enrollment at one clinical trial
site. We will continue to monitor the COVID-19 pandemic and engage
additional clinical trial sites, as appropriate, based on our
assessment of the impact on our trial. I’m proud of our
team’s focus, dedication and resilience while navigating through
the unique challenges that the COVID-19 pandemic has created,” said
Dr. Neal Walker, President and CEO of Aclaris.
R&D 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 regulatory and research
and development activities listed below.
- ATI-450:
- ATI-450 is an investigational oral small molecule MK2
inhibitor.
- ATI-450-RA-201: A Phase 2a trial to
investigate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of ATI-450 in subjects with moderate-to-severe
rheumatoid arthritis.
- Aclaris started subject enrollment in the first quarter of
2020. Due to the COVID-19 pandemic, Aclaris temporarily paused
enrollment of subjects in the trial. At this time, Aclaris has
decided to resume enrolling subjects at one clinical trial site.
The initiation of additional clinical trial sites will be
determined on an ongoing basis as the COVID-19 pandemic
evolves.
- Aclaris previously anticipated reporting data from this trial
in the second half of 2020; however, Aclaris expects that the data
may be delayed and will provide an update, at a later date,
regarding the timing of reporting data from this trial.
- ATI-450-PKPD-101: This Phase 1 single and
multiple ascending dose (SAD/MAD) trial evaluated the safety,
tolerability, pharmacokinetics, and pharmacodynamics of orally
administered ATI-450 in 77 healthy subjects.
- Final data from this trial demonstrated that ATI-450:
- resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
- was generally well-tolerated at all doses tested in the trial.
The most common adverse events (reported by 2 or more subjects who
received ATI-450) observed during the trial were dizziness,
headache, upper respiratory tract infection, constipation,
abdominal pain, and nausea;
- had dose-proportional pharmacokinetics (PK) with a terminal
half-life of 9-12 hours in the MAD cohort; and
- had no meaningful food effect or drug-drug interaction with
methotrexate.
- Aclaris is also planning to initiate a Phase 2a clinical trial
of ATI-450 in an additional immuno-inflammatory
indication.
- ATI-1777:
- ATI-1777 is an investigational topical soft-Janus Kinase (JAK)
inhibitor compound.
- Aclaris expects to submit an IND for ATI-1777 for the treatment
of atopic dermatitis in mid-2020.
- If the IND is allowed, Aclaris expects to initiate a Phase 1/2
clinical trial in subjects with atopic dermatitis in the second
half of 2020 evaluating ATI-1777 as a potential topical treatment
for moderate-to-severe atopic dermatitis.
- ATI-2138:
- ATI-2138 is an investigational oral ITK/TXK/JAK3 (ITJ)
inhibitor compound that Aclaris is developing as a potential
treatment for psoriasis and/or inflammatory bowel disease.
- Aclaris expects to submit an IND for ATI-2138 in the fourth
quarter of 2020 or the first quarter of 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 March 31, 2020, Aclaris had aggregate cash, cash
equivalents and restricted cash and marketable securities of $79.0
million compared to $75.0 million as of December 31, 2019. For the
quarter ended March 31, 2020, net cash used in operating activities
was $6.8 million, which includes $5.2 million received from
Allergan Sales, LLC on behalf of EPI Health, LLC for sales of
RHOFADE (oxymetazoline hydrochloride) cream, 1%. On March 30, 2020,
Aclaris entered into a loan and security agreement with Silicon
Valley Bank pursuant to which Aclaris borrowed $11.0 million. As of
March 31, 2020, Aclaris had approximately 41.8 million shares of
common stock outstanding. Aclaris anticipates that its cash, cash
equivalents and marketable securities as of March 31, 2020, will be
sufficient to fund its operations into the first quarter of 2022,
without giving effect to any potential business development
transactions or financing activities.
First Quarter 2020 Financial Results
- The accompanying 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. The accompanying financial statement data are generally
presented in conformity with Aclaris’ historical format.
Aclaris believes this format provides comparability with its
previously filed financial statements.
- Net loss was $15.6 million for the first quarter of 2020,
compared to $37.6 million for the first quarter of 2019. Total
costs and expenses from continuing operations for the first quarter
of 2020 were $16.9 million, compared to $28.3 million for the first
quarter of 2019.
- Total costs and expenses in the first quarter of 2020 included
non-cash stock-based compensation expense of $3.5 million, compared
to $4.3 million in the prior year period.
- R&D expenses were $9.4 million for the quarter ended March
31, 2020, compared to $19.6 million for the prior year period.
- The quarter-over-quarter decrease of $10.2 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.
- These reductions were offset by a $1.8 million non-cash charge
for the change in the fair value of contingent consideration that
was recorded in the first quarter of 2020.
- General and administrative expenses were $6.2 million for the
first quarter of 2020, compared to $7.5 million for the first
quarter of 2019. The decrease was primarily the result of lower
personnel and stock-based compensation related costs due to lower
headcount.
- Loss from continuing operations was $15.3 million for the first
quarter of 2020 compared to $27.3 million for the first quarter of
2019, while our loss from discontinued operations was $0.3 million
for the first quarter of 2020 compared to $10.3 million for the
first quarter of 2019.
About Aclaris Therapeutics, Inc.Aclaris
Therapeutics, Inc. is a physician-led biopharmaceutical company
committed to addressing 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 and follow Aclaris on LinkedIn or Twitter
@aclaristx.
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, timing for initiation of 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 and marketable securities
will be sufficient to fund its operations into 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
March 31, 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” 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(unaudited, in
thousands, except share and per share data)
|
|
Three Months Ended |
|
|
March 31, |
|
|
2020 |
|
|
2019 |
|
Revenues: |
|
|
|
|
|
|
Contract research |
|
$ |
1,189 |
|
|
$ |
1,263 |
|
Other revenue |
|
|
218 |
|
|
|
— |
|
Total revenue |
|
|
1,407 |
|
|
|
1,263 |
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
Cost of revenue (1) |
|
|
1,269 |
|
|
|
1,207 |
|
Research and development (1) |
|
|
9,444 |
|
|
|
19,643 |
|
General and administrative (1) |
|
|
6,200 |
|
|
|
7,464 |
|
Total costs and expenses |
|
|
16,913 |
|
|
|
28,314 |
|
Loss from operations |
|
|
(15,506 |
) |
|
|
(27,051 |
) |
Other income (expense), net |
|
|
178 |
|
|
|
(230 |
) |
Loss from continuing
operations |
|
|
(15,328 |
) |
|
|
(27,281 |
) |
Loss from discontinued operations
(1) |
|
|
(258 |
) |
|
|
(10,284 |
) |
Net loss |
|
$ |
(15,586 |
) |
|
$ |
(37,565 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.91 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
41,618,429 |
|
|
|
41,248,663 |
|
|
|
|
|
|
|
|
(1) Amounts include stock-based
compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
260 |
|
|
$ |
206 |
|
Research and development |
|
|
816 |
|
|
|
1,594 |
|
General and administrative |
|
|
2,377 |
|
|
|
2,472 |
|
Loss from discontinued
operations |
|
|
— |
|
|
|
590 |
|
Total stock-based compensation
expense |
|
$ |
3,453 |
|
|
$ |
4,862 |
|
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
restricted cash and marketable securities |
|
$ |
79,005 |
|
$ |
75,015 |
|
Total assets |
|
|
96,812 |
|
|
98,297 |
|
Total current liabilities |
|
|
20,603 |
|
|
22,432 |
|
Total liabilities |
|
|
38,637 |
|
|
28,385 |
|
Total stockholders' equity |
|
|
58,175 |
|
|
69,912 |
|
|
|
|
|
|
|
|
|
Aclaris Contactinvestors@aclaristx.com
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