Aclaris Therapeutics Reports Third Quarter 2021 Financial Results and Provides a Corporate Update
November 02 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 third quarter of 2021 and provided a
corporate update.
“This quarter we are pleased to announce the submission of an
investigational new drug application for ATI-2138, our
investigational oral ITK/TXK/JAK3 inhibitor, the third novel
clinical candidate generated by our proprietary KINect® drug
discovery platform,” said Dr. Neal Walker, President & CEO of
Aclaris. “If allowed, we plan to progress ATI-2138 into a Phase 1
trial. We also continue to make progress toward initiating a Phase
2b trial of zunsemetinib (ATI-450) in moderate to severe rheumatoid
arthritis and Phase 2 trials of zunsemetinib in psoriatic arthritis
and moderate to severe hidradenitis suppurativa, as well as our
Phase 2b trial of ATI-1777 in moderate to severe atopic
dermatitis.”
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
- MK2 Inhibitor Asset
- Zunsemetinib
(ATI-450), an investigational oral small molecule MK2
inhibitor compound:
- Zunsemetinib has
been adopted as the nonproprietary name for ATI-450.
- Aclaris plans to
progress zunsemetinib into a Phase 2b trial in moderate to severe
rheumatoid arthritis in the fourth quarter of 2021.
- Aclaris also plans
to progress zunsemetinib into Phase 2 trials in psoriatic arthritis
and moderate to severe hidradenitis suppurativa.
- In pre-clinical
studies, positive effects on MK2 inhibition have been observed for
breast cancer metastasis and cancer-associated bone loss.
-
- “Soft” JAK Inhibitor
Asset
-
ATI-1777, an investigational topical “soft” Janus
kinase (JAK) 1/3 inhibitor compound:
- Aclaris plans to
progress ATI-1777 into a Phase 2b trial in moderate to severe
atopic dermatitis 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.
- Preclinical
Programs
-
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.
- Aclaris submitted an
Investigational New Drug Application (IND) for ATI-2138 for the
treatment of psoriasis in October 2021 and, if allowed, Aclaris
plans to progress to a first-in-human Phase 1 single ascending dose
trial of ATI-2138 in healthy volunteers.
-
-
ATI-2231, an investigational oral MK2 inhibitor
compound:
- Second MK2 inhibitor
generated from Aclaris’ proprietary KINect® drug discovery platform
and designed to have a long half-life.
- 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.
- IND-enabling studies
are underway.
- Discovery
Programs
- Currently developing
oral gut-restricted 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.
- Planned
Retirement
- Kamil Ali-Jackson,
Co-Founder, Chief Legal Officer, Chief Compliance Officer and
Corporate Secretary has announced her retirement, effective January
3, 2022. “Kamil was one of the co-founders of Aclaris in 2012 and
on behalf of the entire Aclaris team and our Board of Directors, I
thank Kamil for her hard work and dedication to the company,” said
Dr. Walker. “During her tenure, Kamil has been responsible for
building and overseeing Aclaris’ Legal, Compliance, Corporate
Communications, Human Resources, and Quality functions and her
significant contributions have contributed to the success of the
company. We wish Kamil the very best in her retirement.”
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2021, Aclaris had aggregate cash, cash
equivalents and marketable securities of $243.6 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 nine months ended September 30, 2021 included:
- Net cash used in
operating activities of $35.1 million. This amount was
comprised of the following:
- $68.1 million net
loss
- $0.8 million cash
used from changes in operating assets and liabilities
- $22.1 million of
non-cash charges for the revaluation of contingent
consideration
- $10.2 million of
non-cash stock-based compensation expense
- $1.5 million of
other non-cash charges
- Net cash used to
repay outstanding debt and fees of $11.5 million in July 2021.
- Net proceeds of
$238.2 million from public offerings in January 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 September 30, 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
Third Quarter 2021
- Net loss was $21.1
million for the third quarter of 2021 compared to $10.7 million for
the third quarter of 2020.
- Total revenue was
$1.7 million for the third quarter of 2021 compared to $1.4 million
for the third quarter of 2020.
- Research and
development (R&D) expenses were $14.0 million for the quarter
ended September 30, 2021 compared to $6.2 million for the prior
year period.
- The $7.7 million
increase was primarily the result of additional zunsemetinib
expenses, including costs associated with drug product
manufacturing and clinical development activities for a Phase 2b
trial for moderate to severe rheumatoid arthritis and a Phase 2
trial for moderate to severe hidradenitis suppurativa.
- General and
administrative (G&A) expenses were $6.0 million for the quarter
ended September 30, 2021 compared to $3.9 million for the prior
year period.
- The $2.1 million
increase was primarily the result of higher compensation-related
costs, including stock-based compensation as well as higher
accounting, compliance and professional fees.
- Revaluation of
contingent consideration charges related to the Confluence
acquisition was $0.9 million for the quarter ended September 30,
2021 compared to $0.6 million for the prior year period.
Year-to-date 2021
- Net loss was $68.1
million for the nine months ended September 30, 2021 compared to
$37.8 million for the nine months ended September 30, 2020.
- Total revenue was
$5.3 million for the nine months ended September 30, 2021 compared
to $4.9 million for the nine months ended September 30, 2020.
- R&D expenses
were $29.7 million for the nine months ended September 30, 2021
compared to $20.4 million for the prior year period.
- The $9.3 million
increase was primarily the result of additional zunsemetinib
expenses, including costs associated with drug product
manufacturing and clinical development activities for a Phase 2b
trial for moderate to severe rheumatoid arthritis and a Phase 2
trial for moderate to severe hidradenitis suppurativa.
Continued investment in the further development of Aclaris’
immuno-inflammatory drug development pipeline also contributed to
the increase as Aclaris progressed towards an IND submission for
ATI-2138.
- G&A expenses
were $16.7 million for the nine months ended September 30, 2021
compared to $15.6 million for the prior year period.
- The $1.0 million
increase was primarily the result of higher accounting, compliance
and professional fees.
- Revaluation of
contingent consideration charges related to the Confluence
acquisition was $22.1 million for the nine months ended September
30, 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, 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 |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Contract research |
$ |
1,415 |
|
|
$ |
1,331 |
|
|
$ |
4,556 |
|
|
$ |
4,373 |
|
Other revenue |
|
244 |
|
|
|
118 |
|
|
|
704 |
|
|
|
529 |
|
Total revenue |
|
1,659 |
|
|
|
1,449 |
|
|
|
5,260 |
|
|
|
4,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
1,099 |
|
|
|
1,189 |
|
|
|
3,564 |
|
|
|
3,847 |
|
Research and development (1) |
|
13,976 |
|
|
|
6,240 |
|
|
|
29,711 |
|
|
|
20,382 |
|
General and administrative (1) |
|
5,979 |
|
|
|
3,859 |
|
|
|
16,676 |
|
|
|
15,632 |
|
Revaluation of contingent consideration |
|
900 |
|
|
|
626 |
|
|
|
22,139 |
|
|
|
2,393 |
|
Total costs and expenses |
|
21,954 |
|
|
|
11,914 |
|
|
|
72,090 |
|
|
|
42,254 |
|
Loss from operations |
|
(20,295 |
) |
|
|
(10,465 |
) |
|
|
(66,830 |
) |
|
|
(37,352 |
) |
Other expense, net |
|
(851 |
) |
|
|
(194 |
) |
|
|
(1,231 |
) |
|
|
(205 |
) |
Loss from continuing
operations |
|
(21,146 |
) |
|
|
(10,659 |
) |
|
|
(68,061 |
) |
|
|
(37,557 |
) |
Loss from discontinued
operations |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(285 |
) |
Net loss |
$ |
(21,146 |
) |
|
$ |
(10,659 |
) |
|
$ |
(68,061 |
) |
|
$ |
(37,842 |
) |
Net loss per share, basic and
diluted |
$ |
(0.35 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.23 |
) |
|
$ |
(0.90 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
61,219,321 |
|
|
|
42,802,582 |
|
|
|
55,215,037 |
|
|
|
42,187,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based
compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
$ |
206 |
|
|
$ |
216 |
|
|
$ |
787 |
|
|
$ |
728 |
|
Research and development |
|
939 |
|
|
|
437 |
|
|
|
2,969 |
|
|
|
2,192 |
|
General and administrative |
|
2,557 |
|
|
|
1,288 |
|
|
|
6,453 |
|
|
|
5,783 |
|
Total stock-based compensation
expense |
$ |
3,702 |
|
|
$ |
1,941 |
|
|
$ |
10,209 |
|
|
$ |
8,703 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
|
September 30, 2021 |
|
December 31, 2020 |
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
243,617 |
|
$ |
54,131 |
Total assets |
$ |
263,494 |
|
$ |
70,784 |
Total current liabilities |
$ |
17,839 |
|
$ |
14,874 |
Total liabilities |
$ |
46,913 |
|
$ |
33,134 |
Total stockholders' equity |
$ |
216,581 |
|
$ |
37,650 |
Common stock outstanding |
|
61,226,750 |
|
|
45,109,314 |
Aclaris Contactinvestors@aclaristx.com
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