Aclaris Therapeutics Reports First Quarter 2021 Financial Results and Provides a Corporate Update
May 07 2021 - 6:00AM
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 first quarter of 2021 and provided a
corporate update.
“We’re very pleased with the progress of our novel
immuno-inflammatory drug development pipeline and look forward to
reporting data from our Phase 2a trial of ATI-1777 in the second
quarter of 2021,” said Dr. Neal Walker, President & CEO of
Aclaris. “ATI-1777 is our second development program generated by
KINect, our proprietary drug discovery platform. After generating
proof of mechanism in inhibiting TNFα, IL1β and IL6 in our Phase 2a
trial of ATI-450 in moderate to severe rheumatoid arthritis, we are
planning to move ATI-450 forward with a Phase 2b trial in moderate
to severe rheumatoid arthritis in the second half of 2021 and
planning to initiate two additional trials of ATI-450 in
hidradenitis suppurativa and psoriatic arthritis.”
Research and Development Highlights:
The global COVID-19 pandemic 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: A Phase 2a, multicenter,
randomized, investigator and patient-blind, sponsor-unblinded,
parallel group, placebo-controlled clinical trial to investigate
the safety, tolerability, pharmacokinetics and pharmacodynamics of
ATI-450 in 19 subjects with moderate to severe rheumatoid
arthritis. The trial consisted of a 12-week treatment period and a
4-week follow-up period. Two subjects withdrew from the trial
during the treatment period, one in the treatment arm and one in
the placebo arm.
- Final per-protocol analysis, which consisted of 17 subjects who
completed the treatment period (15 in the treatment arm and two in
the placebo arm), confirmed that ATI-450 demonstrated durable
clinical activity, as defined by a marked and sustained reduction
in DAS28-CRP and improvement of ACR20/50/70 responses over 12
weeks.
- Overall, ATI-450 was generally well tolerated. There were no
treatment-related serious adverse events and all adverse events
were mild to moderate. There was one non-treatment-related serious
adverse event (COVID-19) reported in the 4-week follow-up period of
the trial in a subject who was no longer receiving treatment. The
subject withdrew during the 4-week follow-up period of the
trial.
- Aclaris intends to progress ATI-450 into a Phase 2b trial in
moderate to severe rheumatoid arthritis in the second half of
2021.
- As part of its planned expansion of its Phase 2
immuno-inflammatory clinical development programs, Aclaris also
plans to progress ATI-450 into Phase 2 trials in hidradenitis
suppurativa and psoriatic arthritis.
- 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 50 subjects with
moderate to severe atopic dermatitis. The primary endpoint is the
percentage change from baseline in the Eczema Area and Severity
Index (EASI) score at week 4.
- Enrollment in this trial was completed in March 2021.
- Data from this trial are now expected in the second quarter of
2021.
- ATI-2138, an investigational oral ITK/TXK/JAK3
(ITJ) inhibitor compound:
- Currently being developed as a potential treatment for T-cell
mediated diseases such as psoriasis and/or inflammatory bowel
disease.
- Submission of Investigational New Drug Application is expected
in the second half of 2021.
Aclaris is also expanding its Scientific Advisory Board with the
addition of Dr. Philip Mease. Dr. Mease, a rheumatologist,
currently serves as a Director of the Division of Rheumatology
Clinical Research at the Swedish Medical Center/Providence St.
Joseph Health and is a Clinical Professor at the University of
Washington in Seattle. His major clinical and research focus is
psoriatic arthritis and axial spondyloarthritis.
Financial Highlights:
Liquidity and Capital Resources
As of March 31, 2021, Aclaris had aggregate cash, cash
equivalents and marketable securities of $142.7 million compared to
$54.1 million as of December 31, 2020. The primary factors for the
change in cash, cash equivalents and marketable securities during
the three months ended March 31, 2021 included:
- Net proceeds of $103.3 million from a public offering in
January 2021 in which Aclaris sold 6.3 million shares of common
stock.
- Net cash used in operating activities of $12.2 million
resulting from net loss of $28.8 million and changes in operating
assets and liabilities of $2.9 million, partially offset by
non-cash adjustments of $19.4 million which was primarily related
to a $16.4 million charge for the revaluation of contingent
consideration.
Aclaris anticipates that its cash, cash equivalents and
marketable securities as of March 31, 2021 will be sufficient to
fund its operations through the end of 2023, including estimated
costs for the Phase 2b trial of ATI-450 for moderate to severe
rheumatoid arthritis and the planned expansion of its Phase 2
immuno-inflammatory clinical development programs for hidradenitis
suppurativa and psoriatic arthritis, without giving effect to any
potential business development transactions or financing
activities.
Financial Results
First Quarter 2021
- Net loss was $28.8 million for the first quarter of 2021
compared to $15.6 million for the first quarter of 2020.
- Total revenue was $1.8 million for the first quarter of 2021
compared to $1.4 million for the first quarter of 2020.
- Research and development (R&D)
expenses were $7.8 million for the quarter ended March 31, 2021
compared to $7.7 million for the prior year period.
- The quarter-over-quarter increase of $0.1 million was primarily
the result of continued investment in the further development of
Aclaris’ immuno-inflammatory drug development pipeline, including
ATI-450, ATI-1777 and ATI-2138, partially offset by a reduction in
spend for legacy dermatology assets and personnel costs.
- General and administrative (G&A)
expenses were $4.8 million for the quarter ended March 31, 2021
compared to $6.2 million for the prior year period.
- The quarter-over-quarter decrease of $1.4 million was primarily
the result of lower personnel and non-cash stock-based compensation
expenses.
- Revaluation of contingent
consideration charges related to the Confluence acquisition was
$16.4 million for the quarter ended March 31, 2021 compared to $1.8
million for the prior year period.
- The quarter-over-quarter increase
in contingent consideration of $14.7 million primarily resulted
from updates to probability of success and estimated future sales
level assumptions following the completion of a Phase 2a clinical
trial of ATI-450 in subjects with moderate to severe rheumatoid
arthritis.
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
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 and timing for regulatory filings, and its belief that its
existing cash, cash equivalents and marketable securities will be
sufficient to fund its operations through the end of 2023. 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,
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.Condensed Consolidated Statements of
Operations(unaudited, in thousands, except share and per share
data)
|
|
Three Months Ended |
|
|
March 31, |
|
|
2021 |
|
|
2020 |
|
Revenues: |
|
|
|
|
|
|
Contract research |
|
$ |
1,535 |
|
|
$ |
1,189 |
|
Other revenue |
|
|
242 |
|
|
|
218 |
|
Total revenue |
|
|
1,777 |
|
|
|
1,407 |
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
Cost of revenue (1) |
|
|
1,202 |
|
|
|
1,269 |
|
Research and development (1) |
|
|
7,838 |
|
|
|
7,677 |
|
General and administrative (1) |
|
|
4,827 |
|
|
|
6,200 |
|
Revaluation of contingent consideration |
|
|
16,439 |
|
|
|
1,767 |
|
Total costs and expenses |
|
|
30,306 |
|
|
|
16,913 |
|
Loss from operations |
|
|
(28,529 |
) |
|
|
(15,506 |
) |
Other income (expense), net |
|
|
(225 |
) |
|
|
178 |
|
Loss from continuing
operations |
|
|
(28,754 |
) |
|
|
(15,328 |
) |
Loss from discontinued
operations |
|
|
— |
|
|
|
(258 |
) |
Net loss |
|
$ |
(28,754 |
) |
|
$ |
(15,586 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.57 |
) |
|
$ |
(0.37 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
50,337,807 |
|
|
|
41,618,429 |
|
|
|
|
|
|
|
|
(1)
Amounts include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
247 |
|
|
$ |
260 |
|
Research and development |
|
|
876 |
|
|
|
816 |
|
General and administrative |
|
|
1,552 |
|
|
|
2,377 |
|
Total stock-based compensation
expense |
|
$ |
2,675 |
|
|
$ |
3,453 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
142,657 |
|
$ |
54,131 |
Total assets |
|
$ |
161,399 |
|
$ |
70,784 |
Total current liabilities |
|
$ |
14,505 |
|
$ |
14,874 |
Total liabilities |
|
$ |
49,105 |
|
$ |
33,134 |
Total stockholders' equity |
|
$ |
112,294 |
|
$ |
37,650 |
Common stock outstanding |
|
|
52,081,729 |
|
|
45,109,314 |
Aclaris Contact
investors@aclaristx.com
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