Aclaris Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Corporate Update
2024年2月27日 - 9:00PM
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 2023 and
provided a corporate update.
“As we enter 2024, we are financially strong,
focused and motivated,” stated Dr. Neal Walker, co-founder and
Interim Chief Executive Officer & President of Aclaris.
“Returning to the CEO role, I look forward to building on our
strong foundation and deep expertise in kinase discovery and
development as we look to shape the future of Aclaris.”
Research and Development
Highlights:
- ATI-1777, an investigational topical “soft”
JAK 1/3 inhibitor
- In January 2024, Aclaris reported positive top-line results
from its Phase 2b trial in atopic dermatitis, and is currently
seeking a development and commercialization partner for this
program.
- ATI-2138, an investigational oral covalent
ITK/JAK3 inhibitor
- Aclaris is assessing the most effective development pathway,
including the lead indication, for ATI-2138. Aclaris reported
positive results from its Phase 1 MAD trial of ATI-2138 in
September 2023.
- Zunsemetinib (ATI-450), an investigational
oral small molecule MK2 inhibitor
- Aclaris plans to support Washington University in St. Louis in
its investigator-initiated Phase 1b/2 trials of zunsemetinib as a
potential treatment for pancreatic cancer and metastatic breast
cancer. Aclaris expects these trials to be primarily funded by
grants awarded to Washington University.
- ATI-2231, Aclaris’ second MK2 inhibitor, was previously being
developed for oncology and Aclaris was supporting Washington
University in an investigator-initiated Phase 1a trial of ATI-2231
in patients with advanced solid tumor malignancies. However,
Aclaris and Washington University agreed to instead study
zunsemetinib in oncology in order to expedite the development
timeline by eliminating the need to conduct the Phase 1a trial due
to zunsemetinib’s more advanced clinical package.
- Discovery
- Aclaris plans to continue to advance discovery programs through
KINect®, its proprietary drug discovery platform.
Financial Highlights:
Liquidity and Capital
Resources
As of December 31, 2023, Aclaris had aggregate
cash, cash equivalents and marketable securities of $181.9 million
compared to $229.8 million as of December 31, 2022.
Financial Results
Fourth Quarter 2023
- Net loss was $1.5 million for the fourth quarter of 2023
compared to $27.6 million for the fourth quarter of 2022.
- Total revenue was $17.6 million for the fourth quarter of 2023
compared to $7.8 million for the fourth quarter of 2022. The
increase was primarily driven by a one-time upfront payment under
the license agreement with Sun Pharmaceutical Industries, Inc. (Sun
Pharma) received in the fourth quarter of 2023.
- Research and development (R&D) expenses were $26.6 million
for the quarter ended December 31, 2023 compared to $21.1 million
for the prior year period. The $5.5 million increase was primarily
the result of an increase in expenses associated with drug
candidate manufacturing for zunsemetinib.
- General and administrative (G&A) expenses were $8.2 million
for the quarter ended December 31, 2023 compared to $7.1 million
for the corresponding prior year period. The increase was primarily
due to an increase in personnel and stock-based compensation
expenses.
- Licensing expenses were $5.7 million for the quarter ended
December 31, 2023 compared to $0.6 million for the prior year
period. The increase was primarily attributable to amounts payable
to third parties in connection with amounts earned under the Sun
Pharma license agreement.
- Revaluation of contingent consideration resulted in a $26.3
million gain for the quarter ended December 31, 2023 compared to a
charge of $7.1 million for the prior year period.
- Intangible asset impairment charges were $6.6 million for the
quarter ended December 31, 2023, representing the full balance of
the in-process research and development (IPR&D) intangible
asset. The impairment charge resulted from Aclaris’ decision to
discontinue further development of the drug candidate for
immuno-inflammatory diseases.
Full Year 2023
- Net loss was $88.5 million for the year ended December 31, 2023
compared to $86.9 million for the year ended December 31,
2022.
- Total revenue was $31.2 million for the year ended December 31,
2023 compared to $29.8 million for the year ended December 31,
2022. The increase was primarily driven by a one-time upfront
payment under the license agreement with Sun Pharma received in the
year ended December 31, 2023. The increase was partially offset by
both a one-time upfront payment received under a license agreement
with Eli Lilly and Company and a one-time upfront payment received
under a license agreement with Pediatrix Therapeutics, Inc. in the
year ended December 31, 2022.
- R&D expenses were $98.4 million for the year ended December
31, 2023 compared to $77.8 million for the prior year period.
- The $20.6 million increase was primarily the result of higher:
- Zunsemetinib development expenses, including costs associated
with clinical activities for the Phase 2b trial for rheumatoid
arthritis and drug candidate manufacturing costs;
- ATI-2138 development expenses, including costs associated with
the Phase 1 MAD trial and other preclinical activities; and
- Compensation-related expenses due to an increase in
headcount.
- G&A expenses were $32.4 million for the year ended December
31, 2023 compared to $25.1 million for the prior year period.
- The $7.3 million increase was primarily the result of higher
compensation-related costs due to increased headcount and the
impact of equity awards granted during the year ended December 31,
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 $26.9
million gain for the year ended December 31, 2023 compared to a
charge of $4.7 million for the corresponding prior year
period.
- Intangible asset impairment charges were $6.6 million for the
year ended December 31, 2023, representing the full balance of the
IPR&D intangible asset. The impairment charge resulted from
Aclaris’ decision to discontinue further development of the drug
candidate for immuno-inflammatory diseases.
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 its development plans for its development programs,
including its plans to seek a development and commercialization
partner for ATI-1777 and its strategic review of its business.
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,
2023, 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, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
566 |
|
|
$ |
866 |
|
|
$ |
3,035 |
|
|
$ |
4,395 |
|
Licensing |
|
|
17,004 |
|
|
|
6,722 |
|
|
|
28,214 |
|
|
|
25,100 |
|
Other |
|
|
— |
|
|
|
165 |
|
|
|
— |
|
|
|
257 |
|
Total revenue |
|
|
17,570 |
|
|
|
7,753 |
|
|
|
31,249 |
|
|
|
29,752 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
725 |
|
|
|
877 |
|
|
|
3,423 |
|
|
|
4,023 |
|
Research and development (1) |
|
|
26,646 |
|
|
|
21,072 |
|
|
|
98,384 |
|
|
|
77,813 |
|
General and administrative (1) |
|
|
8,214 |
|
|
|
7,146 |
|
|
|
32,412 |
|
|
|
25,133 |
|
Licensing |
|
|
5,703 |
|
|
|
637 |
|
|
|
14,658 |
|
|
|
7,937 |
|
Revaluation of contingent consideration |
|
|
(26,300 |
) |
|
|
7,100 |
|
|
|
(26,900 |
) |
|
|
4,700 |
|
Intangible asset impairment |
|
|
6,629 |
|
|
|
— |
|
|
|
6,629 |
|
|
|
— |
|
Total costs and expenses |
|
|
21,617 |
|
|
|
36,832 |
|
|
|
128,606 |
|
|
|
119,606 |
|
Loss from operations |
|
|
(4,047 |
) |
|
|
(29,079 |
) |
|
|
(97,357 |
) |
|
|
(89,854 |
) |
Other income, net |
|
|
2,189 |
|
|
|
1,444 |
|
|
|
8,509 |
|
|
|
2,946 |
|
Loss before income taxes |
|
|
(1,858 |
) |
|
|
(27,635 |
) |
|
|
(88,848 |
) |
|
|
(86,908 |
) |
Income tax benefit |
|
|
(367 |
) |
|
|
— |
|
|
|
(367 |
) |
|
|
— |
|
Net loss |
|
$ |
(1,491 |
) |
|
$ |
(27,635 |
) |
|
$ |
(88,481 |
) |
|
$ |
(86,908 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.27 |
) |
|
$ |
(1.33 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
70,866,315 |
|
|
|
66,685,580 |
|
|
|
69,808,855 |
|
|
|
65,213,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts
include stock-based compensation expense as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
337 |
|
|
$ |
314 |
|
|
$ |
1,456 |
|
|
$ |
1,151 |
|
Research and development |
|
|
(2,367 |
) |
|
|
1,517 |
|
|
|
6,801 |
|
|
|
3,745 |
|
General and administrative |
|
|
3,296 |
|
|
|
2,982 |
|
|
|
12,285 |
|
|
|
10,143 |
|
Total stock-based compensation
expense |
|
$ |
1,266 |
|
|
$ |
4,813 |
|
|
$ |
20,542 |
|
|
$ |
15,039 |
|
Aclaris Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data |
(unaudited, in thousands, except share data) |
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
December 31, 2022 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
181,877 |
|
$ |
229,813 |
|
Total assets |
|
$ |
197,405 |
|
$ |
254,596 |
|
Total current liabilities |
|
$ |
30,952 |
|
$ |
21,938 |
|
Total liabilities |
|
$ |
40,226 |
|
$ |
56,975 |
|
Total stockholders' equity |
|
$ |
157,179 |
|
$ |
197,621 |
|
Common stock outstanding |
|
|
70,894,889 |
|
|
66,688,647 |
|
Aclaris Therapeutics, Inc. |
Selected Consolidated Cash Flow Data |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
Year EndedDecember 31, 2023 |
|
Year EndedDecember 31, 2022 |
|
Net loss |
|
$ |
(88,481 |
) |
|
$ |
(86,908 |
) |
|
Depreciation and
amortization |
|
|
863 |
|
|
|
797 |
|
|
Stock-based compensation
expense |
|
|
20,542 |
|
|
|
15,039 |
|
|
Revaluation of contingent
consideration |
|
|
(26,900 |
) |
|
|
4,700 |
|
|
Intangible asset impairment
charge |
|
|
6,629 |
|
|
|
— |
|
|
Deferred taxes |
|
|
(367 |
) |
|
|
— |
|
|
Changes in operating assets and
liabilities |
|
|
9,389 |
|
|
|
(1,195 |
) |
|
Net cash used in operating
activities |
|
$ |
(78,325 |
) |
|
$ |
(67,567 |
) |
|
Aclaris Therapeutics
Contact:
investors@aclaristx.com
Aclaris Therapeutics (NASDAQ:ACRS)
過去 株価チャート
から 4 2024 まで 5 2024
Aclaris Therapeutics (NASDAQ:ACRS)
過去 株価チャート
から 5 2023 まで 5 2024