Aclaris Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update
February 24 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 fourth quarter and full year of 2021 and
provided a corporate update.
“2021 was a tremendous year for the progression of our drug
development pipeline, and I’m very proud of what our team has
accomplished,” said Dr. Neal Walker, President & CEO of
Aclaris. “We reported positive data for our Phase 2a trials of
zunsemetinib in subjects with moderate to severe rheumatoid
arthritis (RA) and ATI-1777 in subjects with moderate to severe
atopic dermatitis (AD), and strengthened our balance sheet to
continue this momentum in 2022. Moving forward, we are progressing
zunsemetinib in three immuno-inflammatory indications, moving
ATI-1777 forward in moderate to severe AD, and progressing ATI-2138
in SAD/MAD studies. Our KINect® drug discovery platform continues
to be productive and we now have three clinical-stage compounds as
well as an early-stage immuno-inflammatory and oncology pipeline.
We have the privilege of working toward the goal of helping address
the needs of patients with immuno-inflammatory diseases as well as
cancer and look forward to progressing our assets to achieve this
goal.”
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.
Clinical Programs
- Zunsemetinib, an investigational oral small
molecule MK2 inhibitor:Currently being developed as a potential
treatment for immuno-inflammatory diseases
- 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 RA is ongoing.
- Aclaris anticipates increasing the size of the patient
population from approximately 195 to approximately 240 subjects and
expects topline data in 2023.
- 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 HS is ongoing.
- Aclaris expects topline data in the first half of 2023.
- ATI-450-PsA-201: Aclaris plans to progress
zunsemetinib (50 mg twice daily) into a Phase 2a trial in subjects
with moderate to severe psoriatic arthritis in the first half of
2022.
- ATI-1777, an investigational topical “soft”
Janus kinase (JAK) 1/3 inhibitor:Currently being developing as a
potential treatment for moderate to severe AD
- Aclaris plans to progress ATI-1777 into a Phase 2b trial in
subjects with moderate to severe AD in the first half of 2022. In
this trial, Aclaris plans to 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.
- 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 expects topline data in 2022.
- If the Phase 1 SAD trial is successful, Aclaris currently plans
to initiate a two-week Phase 1 multiple ascending dose trial of
ATI-2138 in subjects with psoriasis in 2022. Aclaris is also
currently exploring alternative indications to the planned
indication 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.
Discovery Programs
- Currently developing oral gut-biased JAK inhibitors with
limited systemic exposure as potential treatments for inflammatory
bowel disease.
- Central nervous system (CNS) kinase inhibitor targets:
- Currently engaged in research to identify brain penetrant
kinase inhibitor candidates and assess their impact on neuronal
pro-inflammatory cytokine production, microglia growth and
survival, and neurodegeneration.
Other Highlights:
- James Loerop appointed as Chief Business Officer in January
2022.
- Aclaris plans to hire additional key leadership positions over
the coming months to support its operational plans and strategic
direction.
Financial Highlights:
Liquidity and Capital Resources
As of December 31, 2021, Aclaris had aggregate cash, cash
equivalents and marketable securities of $225.7 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 year ended December 31, 2021 included:
- Net cash used in operating activities of $52.1 million. This
amount was comprised of the following:
- $90.9 million net loss
- $1.3 million cash used from changes in operating assets and
liabilities
- $24.3 million of non-cash charges for the revaluation of
contingent consideration
- $14.1 million of non-cash stock-based compensation expense
- $1.7 million of other non-cash charges
- Net cash used to repay outstanding debt and fees of $11.5
million in July 2021.
- Aggregate net proceeds of $238.2 million from public offerings
in January 2021 and June 2021 in which Aclaris sold a total of 14.4
million shares of common stock.
Aclaris anticipates that its cash, cash equivalents and
marketable securities as of December 31, 2021 will be sufficient to
fund its operations through the end of 2024, without giving effect
to any potential business development transactions or financing
activities.
Financial Results
Fourth Quarter 2021
- Net loss was $22.8 million for the fourth quarter of 2021
compared to $13.2 million for the fourth quarter of 2020.
- Total revenue was $1.5 million for the fourth quarter of 2021
compared to $1.6 million for the fourth quarter of 2020.
- Research and development (R&D) expenses were $14.1 million
for the quarter ended December 31, 2021 compared to $9.0 million
for the prior year period.
- The $5.1 million increase was the result of additional
zunsemetinib expenses, including costs associated with clinical
development activities for a Phase 2b trial for moderate to severe
RA and a Phase 2 trial for moderate to severe HS and preclinical
development activities related to ATI-2231.
- General and administrative (G&A) expenses were $6.9 million
for the quarter ended December 31, 2021 compared to $4.9 million
for the prior year period.
- The $2.0 million increase was primarily the result of higher
compensation-related costs, including stock-based compensation, as
well as higher accounting, compliance and professional fees.
Severance payments relating to the retirement of our former Chief
Legal Officer also contributed to the increase.
- Revaluation of contingent consideration charges related to the
Confluence acquisition was $2.2 million for the quarter ended
December 31, 2021 compared to $0 for the prior year period.
Full Year 2021
- Net loss was $90.9 million for the year ended December 31, 2021
compared to $51.0 million for the year ended December 31,
2020.
- Total revenue was $6.8 million for the year ended December 31,
2021 compared to $6.5 million for the year ended December 31,
2020.
- R&D expenses were $43.8 million for the year ended December
31, 2021 compared to $29.3 million for the prior year period.
- The $14.5 million increase was primarily the result of
additional zunsemetinib expenses, including costs associated with
drug candidate development and clinical development activities for
a Phase 2b trial for moderate to severe RA and a Phase 2a trial for
moderate to severe HS. Continued investment in the further
development of Aclaris’ immuno-inflammatory drug development
pipeline also contributed to the increase as Aclaris progressed
toward the October 2021 IND submission for ATI-2138 and began
pre-clinical development activities on ATI-2231.
- G&A expenses were $23.6 million for the year ended December
31, 2021 compared to $20.5 million for the prior year period.
- The $3.1 million increase was primarily the result of higher
stock-based compensation costs as well as higher accounting,
compliance and professional fees. Severance payments relating to
the retirement of our former Chief Legal Officer also contributed
to the increase.
- Revaluation of contingent consideration charges related to the
Confluence acquisition was $24.3 million for the year ended
December 31, 2021 compared to $2.4 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 2024. 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.Consolidated Statements of Operations(unaudited, in
thousands, except share and per share data)
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
1,274 |
|
$ |
1,413 |
|
$ |
5,830 |
|
$ |
5,786 |
Other revenue |
|
|
227 |
|
|
167 |
|
|
931 |
|
|
696 |
Total revenue |
|
|
1,501 |
|
|
1,580 |
|
|
6,761 |
|
|
6,482 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
1,149 |
|
|
1,286 |
|
|
4,713 |
|
|
5,133 |
Research and development (1) |
|
|
14,102 |
|
|
8,956 |
|
|
43,813 |
|
|
29,338 |
General and administrative (1) |
|
|
6,943 |
|
|
4,898 |
|
|
23,619 |
|
|
20,530 |
Revaluation of contingent consideration |
|
|
2,200 |
|
|
— |
|
|
24,339 |
|
|
2,393 |
Total costs and expenses |
|
|
24,394 |
|
|
15,140 |
|
|
96,484 |
|
|
57,394 |
Loss from operations |
|
|
(22,893) |
|
|
(13,560) |
|
|
(89,723) |
|
|
(50,912) |
Other income (expense), net |
|
|
89 |
|
|
(219) |
|
|
(1,142) |
|
|
(424) |
Loss from continuing
operations before income taxes |
|
|
(22,804) |
|
|
(13,779) |
|
|
(90,865) |
|
|
(51,336) |
Income tax benefit |
|
|
— |
|
|
(182) |
|
|
— |
|
|
(182) |
Loss from continuing
operations |
|
|
(22,804) |
|
|
(13,597) |
|
|
(90,865) |
|
|
(51,154) |
Income from discontinued
operations |
|
|
— |
|
|
424 |
|
|
— |
|
|
139 |
Net loss |
|
$ |
(22,804) |
|
$ |
(13,173) |
|
$ |
(90,865) |
|
$ |
(51,015) |
Net loss per share, basic and
diluted |
|
$ |
(0.37) |
|
$ |
(0.30) |
|
$ |
(1.60) |
|
$ |
(1.20) |
Weighted average common shares
outstanding, basic and diluted |
|
|
61,227,800 |
|
|
43,588,095 |
|
|
56,730,583 |
|
|
42,539,293 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
194 |
|
$ |
218 |
|
$ |
981 |
|
$ |
946 |
Research and development |
|
|
897 |
|
|
727 |
|
|
3,866 |
|
|
2,919 |
General and
administrative |
|
|
2,760 |
|
|
1,559 |
|
|
9,213 |
|
|
7,342 |
Total stock-based compensation
expense |
|
$ |
3,851 |
|
$ |
2,504 |
|
$ |
14,060 |
|
$ |
11,207 |
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
|
December 31, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
225,656 |
|
$ |
54,131 |
Total assets |
|
$ |
251,211 |
|
$ |
70,784 |
Total current liabilities |
|
$ |
22,931 |
|
$ |
14,874 |
Total liabilities |
|
$ |
53,870 |
|
$ |
33,134 |
Total stockholders'
equity |
|
$ |
197,341 |
|
$ |
37,650 |
Common stock outstanding |
|
|
61,228,446 |
|
|
45,109,314 |
Aclaris Contactinvestors@aclaristx.com
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