Aclaris Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Corporate Update
November 06 2023 - 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 2023 and provided a
corporate update.
“Throughout the first three quarters of this year, I believe our
company has performed remarkably well in terms of executing across
our clinical development programs,” stated Doug Manion, M.D., Chief
Executive Officer of Aclaris. “Most importantly, we are rapidly
approaching the topline data read-outs for our two most advanced
clinical programs, zunsemetinib in rheumatoid arthritis this month
and ATI-1777 in atopic dermatitis around the end of this year. This
level of high-quality execution is further exemplified as we
advance ATI-2138 in patients with ulcerative colitis, and we’re
pleased to collaborate with Washington University as they advance
ATI-2231 in patients with advanced solid tumor malignancies.”
Research and Development Highlights:
- 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 placebo-controlled 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 patients
with moderate to severe rheumatoid arthritis (RA) completed
enrollment in June 2023. Aclaris continues to expect topline data
this month.
- Psoriatic Arthritis (ATI-450-PsA-201): This
Phase 2a placebo-controlled trial to investigate the efficacy,
safety, tolerability, PK and PD of zunsemetinib (50 mg twice daily)
in patients with moderate to severe psoriatic arthritis (PsA) is
ongoing. Aclaris continues to expect topline data in the first half
of 2024.
- ATI-1777, an investigational topical “soft”
Janus kinase (JAK) 1/3 inhibitor:Currently being developed as a
potential treatment for mild to severe atopic dermatitis (AD)
- Atopic Dermatitis (ATI-1777-AD-202): This
Phase 2b vehicle-controlled trial to determine the efficacy,
safety, tolerability, and PK of multiple doses and application
regimens of ATI-1777 in patients with mild to severe AD completed
enrollment in September 2023. Aclaris continues to expect topline
data around the end of 2023.
- ATI-2138, an investigational oral covalent
ITK/JAK3 inhibitor: Currently being developed as a potential
treatment for ulcerative colitis; Aclaris is also exploring
additional indications for other T cell-mediated autoimmune
diseases
- Healthy Volunteers (ATI-2138-PKPD-102): This
two-week Phase 1 MAD (multiple ascending dose) trial to investigate
the safety, tolerability, PK and PD of ATI-2138 in healthy
volunteers has been completed. Based on analysis of the PK, PD and
safety, Aclaris is progressing ATI-2138 into Phase 2a clinical
development in ulcerative colitis, which it expects to initiate in
early 2024. Aclaris reported the data in September 2023.
- Preliminary data from the MAD trial demonstrated:
- ATI-2138 was generally well tolerated at all doses tested in
the trial;
- ATI-2138 had dose proportional PK; and
- a dose-dependent inhibition of both ITK and JAK3 exploratory PD
biomarkers, with near maximal inhibition achieved at the 30 mg
total daily dose.
- 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. Aclaris is also currently exploring options to use ATI-2231
as a potential treatment for immuno-inflammatory diseases.
- This is the second MK2 inhibitor generated from Aclaris’
proprietary KINect® drug discovery platform and is designed to have
a long plasma half-life.
- Aclaris is supporting Washington University in a first-in-human
investigator-initiated Phase 1a trial of ATI-2231 in patients with
advanced solid tumor malignancies. Aclaris expects clinical
development activities to be initiated in the second half of
2023.
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2023, Aclaris had aggregate cash, cash
equivalents and marketable securities of $187.0 million compared to
$229.8 million as of December 31, 2022.
Aclaris continues to anticipate that its cash, cash equivalents
and marketable securities as of September 30, 2023 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
Third Quarter 2023
- Net loss was $29.3 million for the third quarter of 2023
compared to $20.0 million for the third quarter of 2022.
- Total revenue was $9.3 million for the third quarter of 2023
compared to $19.0 million for the third quarter of 2022. The
decrease was primarily driven by a one-time upfront payment under
the non-exclusive patent license agreement with Eli Lilly and
Company (Lilly) received in the third quarter of 2022.
- Research and development (R&D) expenses were $23.9 million
for the quarter ended September 30, 2023 compared to $23.7 million
for the prior year period.
- The $0.2 million increase was primarily the result of:
- An increase in ATI-2138 development expenses, including costs
associated with a Phase 1 MAD trial and other preclinical
activities; and
- An increase in compensation-related expenses due to an increase
in headcount.
- The increases were partially offset by a decrease in
zunsemetinib costs associated with the completion of the Phase 2a
trial in patients with hidradenitis suppurativa.
- General and administrative (G&A) expenses were $7.1 million
for the quarter ended September 30, 2023 compared to $5.8 million
for the corresponding prior year period. The increase was primarily
due to increased compensation-related expenses due to an increase
in headcount.
- Licensing expenses were $7.3 million for each of the quarters
ended September 30, 2023 and September 30, 2022, resulting from
separate third-party contractual obligations related to the
non-exclusive patent license agreement with Lilly.
- Revaluation of contingent consideration resulted in a $1.7
million charge for the quarter ended September 30, 2023 compared to
a charge of $2.2 million for the prior year period.
Year-to-date 2023
- Net loss was $87.0 million for the nine months ended September
30, 2023 compared to $59.3 million for the nine months ended
September 30, 2022.
- Total revenue was $13.7 million for the nine months ended
September 30, 2023 compared to $22.0 million for the nine months
ended September 30, 2022. The decrease was primarily driven by a
one-time upfront payment under the non-exclusive patent license
agreement with Lilly received in the nine months ended September
30, 2022.
- R&D expenses were $71.7 million for the nine months ended
September 30, 2023 compared to $56.7 million for the corresponding
prior year period.
- The $15.0 million increase was primarily the result of higher:
- Zunsemetinib development expenses, including costs associated
with clinical activities for a Phase 2b trial for RA and a Phase 2a
trial for PsA;
- ATI-2138 development expenses, including costs associated with
a Phase 1 MAD trial and other preclinical activities; and
- Compensation-related expenses due to an increase in
headcount.
- G&A expenses were $24.2 million for the nine months ended
September 30, 2023 compared to $18.0 million for the prior year
period.
- The $6.2 million increase was primarily the result of higher
compensation-related costs, including stock-based compensation, due
to increased headcount and the impact of equity awards granted
during the nine months ended September 30, 2023. Bad debt expense
recorded from Aclaris’ determination that collection of amounts due
from EPI Health are uncertain as a result of their filing for
Chapter 11 bankruptcy protection also contributed to the
increase.
- Revaluation of contingent consideration resulted in a $0.6
million gain for the nine months ended September 30, 2023 compared
to a gain of $2.4 million for the corresponding 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
“anticipate,” “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, 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 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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
705 |
|
|
$ |
1,090 |
|
|
$ |
2,469 |
|
|
$ |
3,529 |
|
Licensing |
|
|
8,577 |
|
|
|
17,898 |
|
|
|
11,210 |
|
|
|
18,378 |
|
Other |
|
|
- |
|
|
|
30 |
|
|
|
- |
|
|
|
92 |
|
Total revenue |
|
|
9,282 |
|
|
|
19,018 |
|
|
|
13,679 |
|
|
|
21,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue(1) |
|
|
848 |
|
|
|
923 |
|
|
|
2,698 |
|
|
|
3,146 |
|
Research and development(1) |
|
|
23,876 |
|
|
|
23,656 |
|
|
|
71,738 |
|
|
|
56,741 |
|
General and administrative(1) |
|
|
7,091 |
|
|
|
5,813 |
|
|
|
24,198 |
|
|
|
17,987 |
|
Licensing |
|
|
7,344 |
|
|
|
7,300 |
|
|
|
8,955 |
|
|
|
7,300 |
|
Revaluation of contingent consideration |
|
|
1,700 |
|
|
|
2,200 |
|
|
|
(600 |
) |
|
|
(2,400 |
) |
Total costs and expenses |
|
|
40,859 |
|
|
|
39,892 |
|
|
|
106,989 |
|
|
|
82,774 |
|
Loss from operations |
|
|
(31,577 |
) |
|
|
(20,874 |
) |
|
|
(93,310 |
) |
|
|
(60,775 |
) |
Other income, net |
|
|
2,316 |
|
|
|
922 |
|
|
|
6,320 |
|
|
|
1,502 |
|
Net loss |
|
$ |
(29,261 |
) |
|
$ |
(19,952 |
) |
|
$ |
(86,990 |
) |
|
$ |
(59,273 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.41 |
) |
|
$ |
(0.30 |
) |
|
$ |
(1.25 |
) |
|
$ |
(0.92 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
70,807,934 |
|
|
|
66,675,337 |
|
|
|
69,452,495 |
|
|
|
64,718,008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
347 |
|
|
$ |
307 |
|
|
$ |
1,119 |
|
|
$ |
837 |
|
Research and development |
|
|
3,072 |
|
|
|
1,400 |
|
|
|
9,168 |
|
|
|
2,228 |
|
General and administrative |
|
|
2,529 |
|
|
|
2,481 |
|
|
|
8,989 |
|
|
|
7,161 |
|
Total stock-based compensation
expense |
|
$ |
5,948 |
|
|
$ |
4,188 |
|
|
$ |
19,276 |
|
|
$ |
10,226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Aclaris Therapeutics, Inc.Selected Consolidated
Balance Sheet Data(unaudited, in thousands, except share data) |
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
186,996 |
|
|
$ |
229,813 |
|
Total assets |
|
$ |
218,354 |
|
|
$ |
254,596 |
|
Total current liabilities |
|
$ |
27,320 |
|
|
$ |
21,938 |
|
Total liabilities |
|
$ |
62,021 |
|
|
$ |
56,975 |
|
Total stockholders' equity |
|
$ |
156,333 |
|
|
$ |
197,621 |
|
Common stock outstanding |
|
|
70,818,954 |
|
|
|
66,688,647 |
|
|
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics, Inc.Selected Consolidated
Cash Flow Data(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
Nine Months EndedSeptember 30,
2023 |
|
Nine Months EndedSeptember 30,
2022 |
|
|
|
|
|
|
|
Net loss |
|
$ |
(86,990 |
) |
|
$ |
(59,273 |
) |
Depreciation and
amortization |
|
|
635 |
|
|
|
607 |
|
Stock-based compensation
expense |
|
|
19,276 |
|
|
|
10,226 |
|
Revaluation of contingent
consideration |
|
|
(600 |
) |
|
|
(2,400 |
) |
Changes in operating assets and
liabilities |
|
|
(3,885 |
) |
|
|
2,388 |
|
Net cash used in operating
activities |
|
$ |
(71,564 |
) |
|
$ |
(48,452 |
) |
|
|
|
|
|
|
|
|
|
Aclaris Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
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