Aclaris Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update
August 03 2022 - 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 2022 and provided a
corporate update.
“It has been a busy first half of the year as we continue in our
pursuit of becoming a leading development-stage immunology
company,” said Dr. Neal Walker, Chief Executive Officer of Aclaris.
“We have strengthened our senior leadership team this year with the
addition of a number of accomplished leaders, including James
Loerop, Chief Business Officer, Gail Cawkwell, MD, PhD, Chief
Medical Officer, and most recently, Doug Manion, MD, President and
Chief Operating Officer. During the second quarter we also were
able to raise additional capital, which extended our expected cash
runway to the end of 2025. We look forward to continuing to advance
our clinical and pre-clinical programs as we move through the
second half of the year.”
Research and Development Highlights:
Clinical Programs
- Zunsemetinib, an investigational oral small
molecule MK2 inhibitor:Currently being developed as a potential
treatment for immuno-inflammatory diseases
- Rheumatoid Arthritis (ATI-450-RA-202): This
Phase 2b dose ranging trial to investigate the efficacy, safety,
tolerability, pharmacokinetics and pharmacodynamics of multiple
doses (20 mg and 50 mg twice daily) of zunsemetinib in combination
with methotrexate in subjects with moderate to severe rheumatoid
arthritis (RA) is ongoing. Aclaris continues to expect topline data
in 2023.
- Hidradenitis Suppurativa (ATI-450-HS-201):
This Phase 2a trial to investigate the efficacy, safety,
tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib
(50 mg twice daily) in subjects with moderate to severe
hidradenitis suppurativa (HS) is ongoing. Aclaris continues to
expect topline data in the first half of 2023.
- Psoriatic Arthritis (ATI-450-PsA-201): Aclaris
initiated study activities in the second quarter in this Phase 2a
trial to investigate the efficacy, safety, tolerability,
pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice
daily) in subjects with moderate to severe psoriatic arthritis
(PsA). Aclaris continues to expect topline data in the first half
of 2023.
- ATI-1777, an investigational topical “soft”
Janus kinase (JAK) 1/3 inhibitor:Currently being developing as a
potential treatment for moderate to severe atopic dermatitis (AD)
- Atopic Dermatitis (ATI-1777-AD-202): This
Phase 2b trial to determine the efficacy, safety, tolerability and
pharmacokinetics of ATI-1777 in subjects with moderate to severe AD
is ongoing. In this trial, Aclaris will explore multiple
concentrations of twice daily treatment with ATI-1777 and a single
concentration of once daily treatment with ATI-1777, in patients 12
years and older. Aclaris continues to expect topline data in the
first half of 2023.
- ATI-2138, an investigational oral ITK/TXK/JAK3
(ITJ) inhibitor:Currently being developed as a potential treatment
for T cell-mediated autoimmune diseases
- ATI-2138-PKPD-101: This Phase 1 single
ascending dose (SAD) trial to investigate the safety, tolerability,
pharmacokinetics and pharmacodynamics of ATI-2138 in healthy
subjects is ongoing. Aclaris continues to expect topline data in
2022.
- If the Phase 1 SAD trial is successful, Aclaris currently plans
to initiate a Phase 1 multiple ascending dose (MAD) trial of
ATI-2138 in subjects with psoriasis in 2022. Aclaris is also
currently exploring alternative indications that are relevant to
the mechanism of action.
Preclinical Programs
- ATI-2231, an investigational oral MK2
inhibitor compound:Currently being explored as a potential
treatment for pancreatic cancer and metastatic breast cancer as
well as in preventing bone loss in patients with metastatic breast
cancer
- Second MK2 inhibitor generated from Aclaris’ proprietary
KINect® drug discovery platform and designed to have a long
half-life.
- IND-enabling studies are underway, and Aclaris expects to
submit an IND by the end of 2022.
Financial Highlights:
Liquidity and Capital Resources
As of June 30, 2022, Aclaris had aggregate cash, cash
equivalents and marketable securities of $256 million compared to
$226 million as of December 31, 2021. Aggregate cash, cash
equivalents and marketable securities as of June 30, 2022 included
$73 million of net proceeds from the sale of 4.8 million shares
under its ATM facility in April 2022.
Aclaris continues to anticipate that its cash, cash equivalents
and marketable securities as of June 30, 2022 will be sufficient to
fund its operations through the end of 2025, without giving effect
to any potential business development transactions or additional
financing activities.
Financial Results
Second Quarter 2022
- Net loss was $20.5 million for the second quarter of 2022
compared to $18.2 million for the second quarter of 2021.
- Total revenue was $1.5 million for the second quarter of 2022
compared to $1.8 million for the second quarter of 2021.
- Research and development (R&D) expenses were $18.8 million
for the quarter ended June 30, 2022 compared to $7.9 million for
the prior year period.
- The $10.9 million increase was primarily the result of higher:
- Zunsemetinib development expenses, including costs associated
with clinical activities for a Phase 2b trial for RA, a Phase 2a
trial for HS and a Phase 2a trial for PsA.
- ATI-1777 development expenses related to drug candidate
manufacturing and other preclinical activities and start-up costs
associated with a Phase 2b clinical trial.
- Preclinical development activities related to ATI-2231.
- Compensation-related expenses due to an increase in
headcount.
- General and administrative (G&A) expenses were $6.1 million
for the quarter ended June 30, 2022 compared to $5.9 million for
the prior year period.
- Revaluation of contingent consideration resulted in a $3.4
million reduction of expense for the quarter ended June 30, 2022
mainly due to higher discount rates, compared to a revaluation of
contingent consideration expense of $4.8 million for the prior year
period.
Year-to-date 2022
- Net loss was $39.3 million for the six months ended June 30,
2022 compared to $46.9 million for the six months ended June 30,
2021.
- Total revenue was $3.0 million for the six months ended June
30, 2022 compared to $3.6 million for the six months ended June 30,
2021.
- R&D expenses were $33.1 million for the six months ended
June 30, 2022 compared to $15.7 million for the prior year period.
- The $17.4 million increase was primarily the result of higher:
- Zunsemetinib development expenses, including costs associated
with clinical activities for a Phase 2b trial for RA, a Phase 2a
trial for HS and a Phase 2a trial for PsA.
- ATI-1777 development expenses related to drug candidate
manufacturing and other preclinical activities and start-up costs
associated with a Phase 2b clinical trial.
- Preclinical development activities related to ATI-2231.
- Compensation-related expenses due to an increase in
headcount.
- G&A expenses were $12.2 million for the six months ended
June 30, 2022 compared to $10.7 million for the prior year period.
- The $1.5 million increase was primarily the result of higher
compensation-related costs, including stock-based compensation, due
to increased headcount and the impact of new equity awards granted
during the six months ended June 30, 2022.
- Revaluation of contingent consideration resulted in a $4.6
million reduction of expense for the six months ended June 30, 2022
mainly due to higher discount rates, compared to a revaluation of
contingent consideration expense of $21.2 million for the prior
year period.
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 development of Aclaris’ drug candidates,
including the timing of its clinical trials and 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 2025. 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, 2021, 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 |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
1,218 |
|
$ |
1,606 |
|
$ |
2,439 |
|
$ |
3,141 |
Other revenue |
|
|
310 |
|
|
218 |
|
|
542 |
|
|
460 |
Total revenue |
|
|
1,528 |
|
|
1,824 |
|
|
2,981 |
|
|
3,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
1,068 |
|
|
1,263 |
|
|
2,223 |
|
|
2,465 |
Research and development (1) |
|
|
18,779 |
|
|
7,897 |
|
|
33,085 |
|
|
15,735 |
General and administrative (1) |
|
|
6,075 |
|
|
5,870 |
|
|
12,174 |
|
|
10,697 |
Revaluation of contingent consideration |
|
|
(3,400) |
|
|
4,800 |
|
|
(4,600) |
|
|
21,239 |
Total costs and expenses |
|
|
22,522 |
|
|
19,830 |
|
|
42,882 |
|
|
50,136 |
Loss from operations |
|
|
(20,994) |
|
|
(18,006) |
|
|
(39,901) |
|
|
(46,535) |
Other income (expense), net |
|
|
462 |
|
|
(155) |
|
|
580 |
|
|
(380) |
Net loss |
|
$ |
(20,532) |
|
$ |
(18,161) |
|
$ |
(39,321) |
|
$ |
(46,915) |
Net loss per share, basic and
diluted |
|
$ |
(0.31) |
|
$ |
(0.34) |
|
$ |
(0.62) |
|
$ |
(0.90) |
Weighted average common shares
outstanding, basic and diluted |
|
|
65,990,031 |
|
|
53,968,405 |
|
|
63,723,123 |
|
|
52,163,136 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
302 |
|
$ |
335 |
|
$ |
530 |
|
$ |
582 |
Research and development |
|
|
941 |
|
|
1,154 |
|
|
828 |
|
|
2,030 |
General and
administrative |
|
|
2,449 |
|
|
2,343 |
|
|
4,680 |
|
|
3,895 |
Total stock-based compensation
expense |
|
$ |
3,692 |
|
$ |
3,832 |
|
$ |
6,038 |
|
$ |
6,507 |
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
|
June 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
255,824 |
|
$ |
225,656 |
Total assets |
|
$ |
277,976 |
|
$ |
251,211 |
Total current liabilities |
|
$ |
16,217 |
|
$ |
22,931 |
Total liabilities |
|
$ |
42,224 |
|
$ |
53,870 |
Total stockholders'
equity |
|
$ |
235,752 |
|
$ |
197,341 |
Common stock outstanding |
|
|
66,667,580 |
|
|
61,228,446 |
Aclaris Therapeutics,
Inc.Selected Consolidated Cash Flow Data(unaudited, in
thousands)
|
|
Six Months EndedJune 30,
2022 |
|
Six Months EndedJune 30,
2021 |
|
|
|
|
|
|
|
Net loss |
|
$ |
(39,321) |
|
$ |
(46,915) |
Depreciation and
amortization |
|
|
414 |
|
|
535 |
Stock-based compensation
expense |
|
|
6,038 |
|
|
6,507 |
Revaluation of contingent
consideration |
|
|
(4,600) |
|
|
21,239 |
Changes in operating assets and
liabilities |
|
|
(3,166) |
|
|
(5,819) |
Net cash used in operating
activities |
|
$ |
(40,635) |
|
$ |
(24,453) |
Aclaris Contact
investors@aclaristx.com
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