Aclaris Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides a Corporate Update
February 25 2021 - 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 fourth quarter and full
year of 2020 and provided a corporate update.
“As we reflect on 2020, we are proud of how we have progressed
our immuno-inflammatory development programs,” said Dr. Neal
Walker, President & CEO of Aclaris. “We are very excited about
the platform potential of ATI-450, an oral MK2 inhibitor which we
have shown to inhibit TNFα, IL1β, and IL6. Given its novel
mechanism, there are several immuno-inflammatory indications that
ATI-450 may potentially address. We are also excited about the
potential of our pipeline which is internally generated from
KINect®, our proprietary drug discovery platform, for various
immuno-inflammatory indications. We look forward to building on
this momentum in 2021.”
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 subjects with moderate to severe rheumatoid arthritis.
- Positive preliminary topline data announced in January 2021. In
this trial, 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. This clinical
activity was further supported by pharmacodynamic analyses showing
a marked and durable inhibition of TNFα, IL1β, IL6, and IL8 in ex
vivo stimulated samples as well as an endogenous inflammation
biomarker analysis which also demonstrated a marked and sustained
inhibition of median concentrations of hsCRP, TNFα, IL6, IL8, and
MIP1β in the treatment arm over the 12 week period.
- ATI-450 was generally well tolerated. The most common adverse
events (AE) (each reported in 2 subjects) were urinary tract
infection (UTI), elevated lipids and ventricular extrasystoles, all
of which were determined to be unrelated to treatment except for
one UTI. There was one non-treatment-related serious adverse event
(COVID-19) reported in the four-week safety follow-up phase of the
trial in a subject who was no longer receiving treatment.
- Aclaris intends to progress ATI-450 into a Phase 2b trial in
moderate to severe rheumatoid arthritis in the second half of
2021.
- Aclaris is currently evaluating additional potential
indications driven by TNFα, IL1β and IL6 as part of its planned
expansion of its Phase 2 immuno-inflammatory clinical development
programs.
- ATI-450-PKPD-102: A Phase 1,
placebo-controlled, randomized, observer-blind clinical trial to
investigate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of ATI-450 at 80 mg and 120mg twice daily in
health subjects.
- Positive preliminary topline data announced in January 2021.
Pharmacodynamic analysis demonstrated incremental cytokine
suppression at these higher doses. ATI-450 was generally well
tolerated. The most common AEs (reported by 2 or more subjects who
received ATI-450) were headache, dizziness, nausea, parasthesia
and, in the post-dosing safety follow-up phase of the trial, dry
skin. These AEs were all mild in severity.
- A final analysis of this trial is underway.
- ATI-450-CAPS-201: A Phase 2a, multicenter,
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.
Due to the COVID-19 pandemic, subject enrollment in this trial was
paused. As a result of the ongoing pandemic and given the positive
preliminary topline data from the ATI-450-RA-201 trial, Aclaris has
decided to focus its efforts and resources on other
immuno-inflammatory diseases.
- 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 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. Data from this trial are expected
mid-year 2021.
- ATI-2138, an investigational oral ITK/TXK/JAK3
(ITJ) inhibitor compound:
- Aclaris is developing ATI-2138 as a potential treatment for
T-cell mediated diseases such as psoriasis and/or inflammatory
bowel disease and expects to submit an Investigational New Drug
Application for ATI-2138 in the second half of 2021.
Financial Highlights:
Liquidity and Capital Resources
As of December 31, 2020, Aclaris had aggregate cash, cash
equivalents, restricted cash and marketable securities of $54.1
million compared to $75.0 million as of December 31, 2019. The
changes in cash and cash equivalents and marketable securities
during the year included:
- Net cash used in operating activities was $38.6 million
resulting from net loss of $51.0 million and changes in operating
assets and liabilities of $2.4 million, partially offset by
non-cash adjustments of $14.7 million.
- Net borrowings of $10.9 million pursuant to a Loan and Security
Agreement.
- Net proceeds of $7.7 million from the sale of 2.1 million
shares of common stock under an equity line of credit
agreement.
In January 2021, Aclaris closed a public offering in which it
sold approximately 6.3 million shares of common stock. Proceeds
from the offering were $103.5 million, net of underwriting
discounts, commissions and offering expenses. Aclaris anticipates
that its cash, cash equivalents and marketable securities as of
December 31, 2020 in combination with the proceeds from the January
2021 public offering will be sufficient to fund its operations
through the end of 2023, without giving effect to any potential
business development transactions or financing activities.
Financial Results
Fourth Quarter 2020
- Net loss was $13.2 million for the fourth quarter of 2020
compared to $18.6 million for the fourth quarter of 2019. Loss from
continuing operations was $13.6 million for the quarter ended
December 31, 2020 compared to $19.2 million for the prior year
period.
- Total revenue was $1.6 million for the fourth quarter of 2020
compared to $1.1 million for the fourth quarter of 2019.
- Research and development (R&D) expenses were $9.0 million
for the quarter ended December 31, 2020 compared to $11.5 million
for the prior year period.
- The quarter-over-quarter decrease of $2.6 million was primarily
the result of expenses related to Aclaris’ legacy JAK inhibitors
ATI-501 and ATI-502, including the substantial completion of
Aclaris’ various Phase 2 clinical trials, and the substantial
completion of two pivotal Phase 3 clinical trials of A-101 45%
Topical Solution in 2019.
- General and administrative (G&A)
expenses were $4.9 million for the quarter ended December 31, 2020
compared to $5.8 million for the prior year period.
- The quarter-over-quarter decrease of
$0.9 million was primarily the result of lower non-cash stock-based
compensation expense resulting from headcount reductions.
Stock-based compensation expense was $1.6 million compared to $2.6
million in the prior year period.
Full Year 2020
- Net loss was $51.0 million for the year ended December 31, 2020
compared to $161.4 million for the year ended December 31, 2019.
Loss from continuing operations was $51.2 million for the year
ended December 31, 2020 compared to $113.5 million for the prior
year period. Income from discontinued operations was $0.1 million
for the year ended December 31, 2020 compared to a loss from
discontinued operations of $47.8 million for the year ended
December 31, 2019.
- Total revenue was $6.5 million for the year ended December 31,
2020 compared to $4.2 million for the year ended December 31,
2019.
- R&D expenses were $31.7 million
for the year ended December 31, 2020 compared to $64.9 million for
the prior year period.
- The decrease of $33.2 million was
primarily the result of expenses related to ATI-501 and ATI-502,
including the substantial completion of Aclaris’ various Phase 2
clinical trials, and the substantial completion of two pivotal
Phase 3 clinical trials of A-101 45% Topical Solution in 2019.
- R&D expenses in 2020 included
non-cash stock-based compensation expense of $2.9 million compared
to $5.1 million in the prior year period.
- G&A expenses were $20.5 million
for the year ended December 31, 2020 compared to $27.8 million for
the prior year period.
- The decrease of $7.3 million was
primarily the result of lower personnel and non-cash stock-based
compensation resulting from headcount reductions.
- G&A expenses in 2020 included non-cash stock-based
compensation expense of $7.3 million compared to $10.3 million in
the prior year period.
- For the year ended December 31, 2019, there was also
a $18.5 million non-cash charge for the impairment of
goodwill.
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.
Consolidated Statements of Operations
(unaudited, in thousands, except share and per
share data)
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Contract research |
$ |
1,413 |
|
|
$ |
1,095 |
|
|
$ |
5,786 |
|
|
$ |
4,227 |
|
Other revenue |
|
167 |
|
|
|
— |
|
|
|
696 |
|
|
|
— |
|
Total revenue |
|
1,580 |
|
|
|
1,095 |
|
|
|
6,482 |
|
|
|
4,227 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
1,286 |
|
|
|
1,028 |
|
|
|
5,133 |
|
|
|
4,055 |
|
Research and development (1) |
|
8,956 |
|
|
|
11,540 |
|
|
|
31,731 |
|
|
|
64,899 |
|
General and administrative (1) |
|
4,898 |
|
|
|
5,809 |
|
|
|
20,530 |
|
|
|
27,827 |
|
Goodwill impairment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
18,504 |
|
Total costs and expenses |
|
15,140 |
|
|
|
18,377 |
|
|
|
57,394 |
|
|
|
115,285 |
|
Loss from operations |
|
(13,560 |
) |
|
|
(17,282 |
) |
|
|
(50,912 |
) |
|
|
(111,058 |
) |
Other expense, net |
|
(219 |
) |
|
|
(1,895 |
) |
|
|
(424 |
) |
|
|
(2,484 |
) |
Loss from continuing operations
before income taxes |
|
(13,779 |
) |
|
|
(19,177 |
) |
|
|
(51,336 |
) |
|
|
(113,542 |
) |
Income tax benefit |
|
(182 |
) |
|
|
— |
|
|
|
(182 |
) |
|
|
— |
|
Loss from continuing
operations |
|
(13,597 |
) |
|
|
(19,177 |
) |
|
|
(51,154 |
) |
|
|
(113,542 |
) |
Income (loss) from discontinued
operations, net of tax (1) |
|
424 |
|
|
|
583 |
|
|
|
139 |
|
|
|
(47,812 |
) |
Net loss |
$ |
(13,173 |
) |
|
$ |
(18,594 |
) |
|
$ |
(51,015 |
) |
|
$ |
(161,354 |
) |
Net loss per share, basic and
diluted |
$ |
(0.30 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.20 |
) |
|
$ |
(3.90 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
43,588,095 |
|
|
|
41,405,657 |
|
|
|
42,539,293 |
|
|
|
41,323,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Amounts include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
$ |
218 |
|
|
$ |
249 |
|
|
$ |
946 |
|
|
$ |
703 |
|
Research and development |
|
727 |
|
|
|
358 |
|
|
|
2,919 |
|
|
|
5,091 |
|
General and administrative |
|
1,559 |
|
|
|
2,581 |
|
|
|
7,342 |
|
|
|
10,288 |
|
Income (loss) from discontinued
operations, net of tax |
|
— |
|
|
|
(7 |
) |
|
|
— |
|
|
|
95 |
|
Total stock-based compensation
expense |
$ |
2,504 |
|
|
$ |
3,181 |
|
|
$ |
11,207 |
|
|
$ |
16,177 |
|
Aclaris Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited, in thousands)
|
|
|
|
|
|
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
|
Cash, cash equivalents,
restricted cash and marketable securities |
|
$ |
54,131 |
|
$ |
75,015 |
|
Total assets |
|
|
70,784 |
|
|
98,297 |
|
Total current liabilities |
|
|
14,874 |
|
|
22,432 |
|
Total liabilities |
|
|
33,134 |
|
|
28,385 |
|
Total stockholders'
equity |
|
|
37,650 |
|
|
69,912 |
|
Aclaris Contact
investors@aclaristx.com
Aclaris Therapeutics (NASDAQ:ACRS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aclaris Therapeutics (NASDAQ:ACRS)
Historical Stock Chart
From Sep 2023 to Sep 2024