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 2022 and
provided a corporate update.
“The past year for Aclaris was marked by tremendous execution
across our organization notably highlighted by our clinical
development programs and our proprietary kinase-focused drug
discovery platform,” stated Doug Manion, M.D., Chief Executive
Officer of Aclaris. “We enter 2023 well positioned to capitalize on
that momentum with multiple data read-outs expected, beginning with
top line data from the Phase 2a trial of zunsemetinib in
hidradenitis suppurativa next month.”
Continued Dr. Manion, “In addition to the enthusiasm related to
our upcoming development-stage milestones, we also continue to
benefit from the output of our KINect® discovery engine, and the
ability to identify novel development candidates, which we believe
will not only position us to continue to build long-term
shareholder value, but also enable us to further fulfill our
mission of delivering new therapeutic options for patients.”
Research and Development Highlights:
Clinical Development 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 (PK) and pharmacodynamics (PD) 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 expects topline data
in the second half of 2023.
- Hidradenitis Suppurativa (ATI-450-HS-201):
This Phase 2a trial to investigate the efficacy, safety,
tolerability, PK and PD of zunsemetinib (50 mg twice daily) over 12
weeks in subjects with moderate to severe hidradenitis suppurativa
(HS) has completed enrollment with 95 patients randomized and is
ongoing. Aclaris expects topline data in March of 2023.
- Psoriatic Arthritis (ATI-450-PsA-201): This
Phase 2a trial to investigate the efficacy, safety, tolerability,
PK and PD of zunsemetinib (50 mg twice daily) in subjects with
moderate to severe psoriatic arthritis (PsA) is ongoing. Aclaris
expects topline data by year end 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
PK of multiple doses and application regimens of ATI-1777 in
subjects with moderate to severe AD is ongoing. Aclaris expects
topline data mid-year 2023.
• ATI-2138, an investigational oral
covalent ITK/JAK3 inhibitor: Currently being
developed as a potential treatment for T cell-mediated autoimmune
diseases
- Aclaris has selected ulcerative colitis as the intended first
clinical development target for ATI-2138. Aclaris is also exploring
additional indications that are relevant to the mechanism of
action.
- Aclaris initiated a Phase 1 MAD (multiple ascending dose) trial
of ATI-2138 in healthy volunteers in December of 2022.
Aclaris expects topline data from the MAD trial in the second half
of 2023.
Preclinical Development Program
• 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 plasma
half-life.
- Aclaris expects clinical development activities to be initiated
in 2023, which is expected to advance as a collaboration with an
academic third party.
Financial Highlights:
Liquidity and Capital Resources
As of December 31, 2022, Aclaris had aggregate cash, cash
equivalents and marketable securities of $229.8 million compared to
$225.7 million as of December 31, 2021. Aggregate cash, cash
equivalents and marketable securities as of December 31, 2022
included proceeds received during the fourth quarter under a
license agreement with Pediatrix Therapeutics, Inc.
(Pediatrix).
Aclaris continues to anticipate that its cash, cash equivalents
and marketable securities as of December 31, 2022 will be
sufficient to fund its operations through the end of 2025, without
giving effect to any potential business development transactions or
financing activities.
Financial Results
Fourth Quarter 2022
- Net loss was $27.6 million for the fourth quarter of 2022
compared to $22.8 million for the fourth quarter of 2021.
- Total revenue was $7.8 million for the fourth quarter of 2022
compared to $1.5 million for the fourth quarter of 2021. The
increase was driven by $6.7 million of licensing revenue in the
quarter, including $5 million from the license agreement with
Pediatrix.
- Research and development (R&D) expenses were $21.1 million
for the quarter ended December 31, 2022 compared to $14.1 million
for the prior year period.
- The $7.0 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 costs associated
with a Phase 2b clinical trial for AD.
- ATI-2138 development expenses, including costs associated with
a Phase 1 SAD trial, a Phase 1 MAD trial, and other preclinical
activities.
- Compensation-related expenses due to an increase in
headcount.
- General and administrative (G&A) expenses were $7.1 million
for the quarter ended December 31, 2022 compared to $6.9 million
for the prior year period.
- Licensing expenses were $0.6 million for the quarter ended
December 31, 2022 resulting primarily from obligations to the
former Confluence equity holders from revenue generated from the
Pediatrix license agreement. There were no licensing expenses for
the quarter ended December 31, 2021.
- Revaluation of contingent consideration was $7.1 million for
the quarter ended December 31, 2022, compared to a revaluation of
contingent consideration expense of $2.2 million for the prior year
period.
Full Year 2022
- Net loss was $86.9 million for the year ended December 31, 2022
compared to $90.9 million for the year ended December 31,
2021.
- Total revenue was $29.8 million for the year ended December 31,
2022 compared to $6.8 million for the year ended December 31, 2021.
- The $23.0 million increase was driven by a $24.3 million
increase in licensing revenue during 2022, which included $17.6
million of upfront and milestone payments received under the
non-exclusive patent license agreement with Eli Lilly and a $5.0
million upfront payment received under the Pediatrix license
agreement. The increase in licensing revenue was offset by a
decrease in contract research revenues.
- R&D expenses were $77.8 million for the year ended December
31, 2022 compared to $43.8 million for the prior year period.
- The $34.0 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 costs associated
with a Phase 2b clinical trial for AD.
- ATI-2138 development expenses, including costs associated with
a Phase 1 SAD trial, a Phase 1 MAD trial, and other preclinical
activities.
- ATI-2231 preclinical development expenses associated with
preclinical activities and IND-enabling studies.
- Compensation-related expenses due to an increase in
headcount.
- Licensing expenses were $7.9 million for the year ended
December 31, 2022 resulting from separate third-party contractual
obligations primarily related to the non-exclusive patent license
agreement with Eli Lilly. There were no licensing expenses for the
year ended December 31, 2021.
- G&A expenses were $25.1 million for the year ended December
31, 2022 compared to $23.6 million for the prior year period.
- The $1.5 million increase was primarily the result of higher
stock-based compensation and personnel costs due to an increase in
headcount.
- Revaluation of contingent consideration charges related to the
Confluence acquisition was $4.7 million for the year ended December
31, 2022 compared to $24.3 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, availability of data
from those trials, and regulatory filings, the identification of
novel development candidates through Aclaris’ KINect discovery
engine, 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
macroeconomic environment and 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,
2022, 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 |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
866 |
|
|
$ |
1,274 |
|
|
$ |
4,395 |
|
|
$ |
5,830 |
|
Licensing |
|
|
6,722 |
|
|
|
197 |
|
|
|
25,100 |
|
|
|
809 |
|
Other |
|
|
165 |
|
|
|
30 |
|
|
|
257 |
|
|
|
122 |
|
Total revenue |
|
|
7,753 |
|
|
|
1,501 |
|
|
|
29,752 |
|
|
|
6,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
877 |
|
|
|
1,149 |
|
|
|
4,023 |
|
|
|
4,713 |
|
Research and development (1) |
|
|
21,072 |
|
|
|
14,102 |
|
|
|
77,813 |
|
|
|
43,813 |
|
General and administrative (1) |
|
|
7,146 |
|
|
|
6,943 |
|
|
|
25,133 |
|
|
|
23,619 |
|
Licensing |
|
|
637 |
|
|
|
— |
|
|
|
7,937 |
|
|
|
— |
|
Revaluation of contingent consideration |
|
|
7,100 |
|
|
|
2,200 |
|
|
|
4,700 |
|
|
|
24,339 |
|
Total costs and expenses |
|
|
36,832 |
|
|
|
24,394 |
|
|
|
119,606 |
|
|
|
96,484 |
|
Loss from operations |
|
|
(29,079 |
) |
|
|
(22,893 |
) |
|
|
(89,854 |
) |
|
|
(89,723 |
) |
Other income (expense), net |
|
|
1,444 |
|
|
|
89 |
|
|
|
2,946 |
|
|
|
(1,142 |
) |
Net loss |
|
$ |
(27,635 |
) |
|
$ |
(22,804 |
) |
|
$ |
(86,908 |
) |
|
$ |
(90,865 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.37 |
) |
|
$ |
(1.33 |
) |
|
$ |
(1.60 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
66,685,580 |
|
|
|
61,227,800 |
|
|
|
65,213,944 |
|
|
|
56,730,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
Amounts include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
314 |
|
|
$ |
194 |
|
|
$ |
1,151 |
|
|
$ |
981 |
|
Research and development |
|
|
1,517 |
|
|
|
897 |
|
|
|
3,745 |
|
|
|
3,866 |
|
General and administrative |
|
|
2,982 |
|
|
|
2,760 |
|
|
|
10,143 |
|
|
|
9,213 |
|
Total stock-based compensation
expense |
|
$ |
4,813 |
|
|
$ |
3,851 |
|
|
$ |
15,039 |
|
|
$ |
14,060 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
|
|
|
|
|
|
|
|
|
December 31, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
229,813 |
|
$ |
225,656 |
|
Total assets |
|
$ |
254,596 |
|
$ |
251,211 |
|
Total current liabilities |
|
$ |
21,938 |
|
$ |
22,931 |
|
Total liabilities |
|
$ |
56,975 |
|
$ |
53,870 |
|
Total stockholders' equity |
|
$ |
197,621 |
|
$ |
197,341 |
|
Common stock outstanding |
|
|
66,688,647 |
|
|
61,228,446 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Cash Flow Data(unaudited, in
thousands)
|
|
|
|
|
|
|
|
|
Year EndedDecember 31, 2022 |
|
Year EndedDecember 31, 2021 |
|
|
|
|
|
|
|
Net loss |
|
$ |
(86,908 |
) |
|
$ |
(90,865 |
) |
Depreciation and
amortization |
|
|
797 |
|
|
|
923 |
|
Stock-based compensation
expense |
|
|
15,039 |
|
|
|
14,060 |
|
Revaluation of contingent
consideration |
|
|
4,700 |
|
|
|
24,339 |
|
Loss on extinguishment of
debt |
|
|
— |
|
|
|
752 |
|
Changes in operating assets and
liabilities |
|
|
(1,195 |
) |
|
|
(1,343 |
) |
Net cash used in operating
activities |
|
$ |
(67,567 |
) |
|
$ |
(52,134 |
) |
Aclaris Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
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