Aclaris Therapeutics Reports Second Quarter 2020 Financial Results and Provides R&D and Business Highlights
August 07 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 second quarter of 2020 and provided
research and development (R&D) and business highlights.
“As the pandemic evolves, our team has continued to work hard to
make the appropriate business adjustments, advance our pipeline and
execute through these uncertain times,” said Dr. Neal Walker,
President and CEO of Aclaris. “In the second quarter, we dosed the
first subject in our Phase 2a trial of ATI-450 as a potential
treatment for moderate to severe rheumatoid arthritis. We are also
proud to be participating in the effort to find effective
therapeutics for COVID-19 by supporting an investigator-initiated
clinical trial of ATI-450 for cytokine release syndrome in
hospitalized patients with COVID-19 and the first subject has been
dosed in this trial. In addition, we are progressing with the
first-in-human trial of ATI-1777 in patients with moderate to
severe atopic dermatitis. We look forward to continuing to execute
on our clinical development plans.”
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, an investigational oral small
molecule MK2 inhibitor compound:
- ATI-450-RA-201: An ongoing Phase 2a trial to
investigate the safety, tolerability, pharmacokinetics and
pharmacodynamics of ATI-450 in subjects with moderate to severe
rheumatoid arthritis.
- This trial was initiated in March 2020. Due to the COVID-19
pandemic, Aclaris temporarily paused enrollment. Aclaris resumed
enrolling subjects, and the first subject was dosed, in May 2020.
At this time, Aclaris is actively recruiting for this trial. Given
the continuing evolution of the COVID-19 pandemic, Aclaris now
anticipates reporting data from this trial in the first half of
2021.
- ATI-450-CAPS-201: Aclaris expects to initiate
a Phase 2a clinical trial of ATI-450 in cryopyrin-associated
periodic syndrome (CAPS), an IL1β-driven disease, in the second
half of 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
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.
- The first subject was dosed in August 2020.
- ATI-1777, an investigational topical “soft”
Janus Kinase (JAK) 1/3 inhibitor compound:
- Aclaris submitted an Investigational New Drug (IND) Application
for ATI-1777 for the treatment of moderate to severe atopic
dermatitis (AD) in June 2020 and now plans to progress to the
first-in-human trial of ATI-1777 in subjects with moderate to
severe AD.
- ATI-1777-AD-201: Aclaris expects to initiate a
Phase 1/2a multicenter, randomized, double-blind,
vehicle-controlled trial to investigate the safety, tolerability,
pharmacokinetics and efficacy of topically applied ATI-1777 in
subjects with moderate to severe AD in the second half of 2020. The
primary endpoint will assess efficacy at four weeks.
- 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 IND 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 June 30, 2020, Aclaris had aggregate cash, cash
equivalents and marketable securities of $68.1 million compared to
$75.0 million as of December 31, 2019. For the quarter and six
months ended June 30, 2020, net cash used in operating activities
was $10.8 million and $17.6 million, respectively. As of June 30,
2020, Aclaris had approximately 42.7 million shares of common stock
outstanding.
Aclaris anticipates that its cash, cash equivalents and
marketable securities as of June 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.
Second Quarter 2020 and Year-to-Date 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.
- Net loss was $11.6 million for the second quarter of 2020,
compared to $49.9 million for the second quarter of 2019, and was
$27.2 million for the six months ended June 30, 2020, compared to
$87.4 million for the six months ended June 30, 2019.
- Total costs and expenses from continuing operations for the
second quarter of 2020 were $13.4 million, compared to $44.5
million for the second quarter of 2019, and were $30.3 million for
the six months ended June 30, 2020, compared to $72.8 million for
the six months ended June 30, 2019.
- Total costs and expenses in the second quarter of 2020 included
non-cash stock-based compensation expense of $3.3 million, compared
to $4.6 million in the prior year period.
- Total costs and expenses for the six months ended June 30, 2020
included non-cash stock-based compensation expense of $6.8 million,
compared to $8.9 million in the prior year period.
- Recorded a non-cash goodwill impairment charge of $18.5 million
for the quarter and six months ended June 30, 2019. There were no
impairment charges in either period in 2020.
- R&D expenses were $6.5 million and $15.9 million for the
quarter and six months ended June 30, 2020, respectively, compared
to $17.5 million and $37.2 million for the quarter and six months
ended June 30, 2019, respectively.
- The quarter-over-quarter decrease of $11.1 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.
- General and administrative expenses were $5.6 million and $11.8
million for the quarter and six months ended June 30, 2020,
respectively, compared to $7.5 million and $14.9 million for the
quarter and six months ended June 30, 2019, respectively.
- The quarter-over-quarter decrease of $1.9 million was primarily
the result of lower personnel costs resulting from the Company’s
decision to discontinue commercial operations in September
2019.
- Loss from continuing operations was $11.6 million and $26.9
million for the quarter and six months ended June 30, 2020,
respectively, compared to $43.7 million and $71.0 million for the
quarter and six months ended June 30, 2019, respectively. Loss from
discontinued operations was $27,000 and $0.3 million for the
quarter and six months ended June 30, 2020, respectively, compared
to $6.2 million and $16.5 million for the quarter and six months
ended June 30, 2019, respectively.
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 and follow Aclaris on LinkedIn
or Twitter @aclaristx.
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,” “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 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
June 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 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 |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
1,853 |
|
$ |
886 |
|
$ |
3,042 |
|
$ |
2,149 |
Other revenue |
|
|
193 |
|
|
— |
|
|
411 |
|
|
— |
Total revenues |
|
|
2,046 |
|
|
886 |
|
|
3,453 |
|
|
2,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
1,389 |
|
|
994 |
|
|
2,658 |
|
|
2,201 |
Research and development (1) |
|
|
6,466 |
|
|
17,519 |
|
|
15,909 |
|
|
37,161 |
General and administrative (1) |
|
|
5,572 |
|
|
7,469 |
|
|
11,773 |
|
|
14,926 |
Goodwill impairment |
|
|
— |
|
|
18,504 |
|
|
— |
|
|
18,504 |
Total costs and expenses |
|
|
13,427 |
|
|
44,486 |
|
|
30,340 |
|
|
72,792 |
Loss from operations |
|
|
(11,381) |
|
|
(43,600) |
|
|
(26,887) |
|
|
(70,643) |
Other expense, net |
|
|
(189) |
|
|
(85) |
|
|
(11) |
|
|
(315) |
Loss from continuing
operations |
|
|
(11,570) |
|
|
(43,685) |
|
|
(26,898) |
|
|
(70,958) |
Loss from discontinued
operations (1) |
|
|
(27) |
|
|
(6,191) |
|
|
(285) |
|
|
(16,483) |
Net loss |
|
$ |
(11,597) |
|
$ |
(49,876) |
|
$ |
(27,183) |
|
$ |
(87,441) |
Net loss per share, basic and
diluted |
|
$ |
(0.28) |
|
$ |
(1.21) |
|
$ |
(0.65) |
|
$ |
(2.12) |
Weighted average common shares
outstanding, basic and diluted |
|
|
42,133,646 |
|
|
41,274,808 |
|
|
41,876,037 |
|
|
41,261,808 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include
stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
252 |
|
$ |
223 |
|
$ |
512 |
|
$ |
429 |
Research and development |
|
|
939 |
|
|
1,721 |
|
|
1,755 |
|
|
3,315 |
General and
administrative |
|
|
2,118 |
|
|
2,654 |
|
|
4,495 |
|
|
5,126 |
Loss from discontinued
operations |
|
|
— |
|
|
216 |
|
|
— |
|
|
806 |
Total stock-based compensation
expense |
|
$ |
3,309 |
|
$ |
4,814 |
|
$ |
6,762 |
|
$ |
9,676 |
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands)
|
|
June 30, 2020 |
|
December 31, 2019 |
|
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
|
$ |
68,115 |
|
$ |
75,015 |
Total assets |
|
|
84,999 |
|
|
98,297 |
Total current liabilities |
|
|
17,745 |
|
|
22,432 |
Total liabilities |
|
|
35,633 |
|
|
28,385 |
Total stockholders'
equity |
|
|
49,366 |
|
|
69,912 |
Aclaris Contactinvestors@aclaristx.com
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