Aclaris Therapeutics Reports Second Quarter 2024 Financial Results and Provides a Corporate Update
07 8월 2024 - 8:00PM
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 second quarter of 2024 and provided a
corporate update.
"With study activities underway for our ATI-2138
Phase 2a trial in moderate to severe atopic dermatitis and the
strengthening of our balance sheet through the completion of our
royalty purchase agreement with OMERS, we're well-positioned to
drive our strategic initiatives forward,” said Dr. Neal Walker,
Interim President & CEO and Chair of the Board of Directors of
Aclaris. “Our focus remains on leveraging our resources to maximize
the potential of our innovative drug candidates, pursue available
opportunities, and create long-term value for patients and
shareholders alike."
Research and Development
Highlights:
- ITK Inhibitor
Programs
- ATI-2138, an
investigational oral covalent ITK/JAK3 inhibitor
- ATI-2138-AD-201:
Aclaris is activating clinical sites and expects to enroll patients
in the coming weeks in this Phase 2a open-label trial to
investigate the safety, tolerability, pharmacokinetics, efficacy,
and pharmacodynamics of ATI-2138 in subjects with moderate to
severe atopic dermatitis (AD).
- ITK Selective
Compound
- Aclaris is progressing to
development candidate selection a second generation ITK selective
inhibitor for autoimmune indications.
- Lepzacitinib
(ATI-1777), an investigational topical “soft” JAK
1/3 inhibitor
- In January 2024, Aclaris reported
positive top-line results from its Phase 2b trial of lepzacitinib
in atopic dermatitis (AD).
- Aclaris is currently seeking a
global development and commercialization partner for this program
(excluding Greater China). As previously announced, in 2022 Aclaris
granted Pediatrix Therapeutics exclusive rights to develop and
commercialize lepzacitinib in Greater China.
- 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.
Financial Highlights:
Liquidity and Capital
Resources
As of June 30, 2024, Aclaris had aggregate cash,
cash equivalents and marketable securities of $149.9 million
compared to $181.9 million as of December 31, 2023. In July 2024,
Aclaris received an upfront payment of $26.5 million and is
eligible to receive up to an additional $5.0 million upon the
achievement of certain sales milestones in connection with the sale
of OLUMIANT® royalties and milestones to OMERS Life Sciences.
Aclaris anticipates that its cash, cash
equivalents and marketable securities as of June 30, 2024 in
combination with the $26.5 million from the sale of OLUMIANT®
royalties and milestones will be sufficient to fund its operations
into 2028, without giving effect to any potential new business
development transactions, additional financing activities or the
outcome of its strategic review.
Financial Results
Second Quarter 2024
- Net loss was $11.0 million for the second quarter of 2024
compared to $29.6 million for the second quarter of 2023.
- Total revenue was $2.8 million for the second quarter of 2024
compared to $1.9 million for the second quarter of 2023. The
increase was primarily driven by an increase in royalties under the
Lilly license agreement during the three months ended June 30,
2024.
- Research and development (R&D) expenses were $8.8 million
for the quarter ended June 30, 2024 compared to $25.3 million for
the prior year period.
- The $16.5 million decrease was primarily the result of lower:
- Zunsemetinib development expenses associated with clinical
activities for a Phase 2a trial for hidradenitis suppurativa which
was completed in March 2023, a Phase 2b trial for rheumatoid
arthritis which was completed in November 2023, a Phase 2b trial
for psoriatic arthritis which was discontinued in December 2023,
and drug candidate manufacturing costs;
- Costs associated with lepzacitinib preclinical development
activities and a Phase 2b clinical trial for AD which was completed
in January 2024;
- ATI-2138 development expenses, including costs associated with
a Phase 1 MAD trial which was completed in September 2023 and other
preclinical activities; and
- Compensation-related expenses due to a decrease in headcount
and higher forfeiture credits.
- General and administrative (G&A) expenses were $4.8 million
for the quarter ended June 30, 2024 compared to $8.3 million for
the prior year period. The decrease was primarily due to a
reduction in compensation-related expenses due to lower headcount
and higher forfeiture credits, along with the recognition of bad
debt expense recorded in the prior year period from Aclaris’
determination that collection of amounts due from EPI Health are
uncertain as a result of their filing for Chapter 11 bankruptcy
protection.
- Licensing expenses were $1.3 million for the quarter ended June
30, 2024 compared to $0.6 million for the prior year period. The
increase was due to an increase in royalties earned under the Lilly
license agreement.
- Revaluation of contingent consideration resulted in a $0.2
million loss for the quarter ended June 30, 2024 compared to a gain
of $1.5 million for the prior year period.
Year-to-date 2024
- Net loss was $27.9 million for the six months ended June 30,
2024 compared to $57.7 million for the six months ended June 30,
2023.
- Total revenue was $5.2 million for the six months ended June
30, 2024 compared to $4.4 million for the six months ended June 30,
2023. The increase was primarily driven by an increase
in royalties under the Lilly license agreement during the six
months ended June 30, 2024.
- R&D expenses were $18.6 million for the six months ended
June 30, 2024 compared to $47.9 million for the prior year period.
- The $29.3 million decrease was primarily the result of lower:
- Zunsemetinib development expenses associated with clinical
activities for a Phase 2a trial for hidradenitis suppurativa which
was completed in March 2023, a Phase 2b trial for rheumatoid
arthritis which was completed in November 2023, a Phase 2b trial
for psoriatic arthritis which was discontinued in December 2023,
and drug candidate manufacturing costs;
- Costs associated with lepzacitinib preclinical development
activities and a Phase 2b clinical trial for AD which was completed
in January 2024;
- ATI-2138 development expenses, including costs associated with
a Phase 1 MAD trial which was completed in September 2023 and other
preclinical activities; and
- Compensation-related expenses due to a decrease in headcount
and higher forfeiture credits.
- G&A expenses were $11.6 million for the six months ended
June 30, 2024 compared to $17.1 million for the prior year period.
The decrease was primarily due to a reduction in
compensation-related expenses due to lower headcount and higher
forfeiture credits, a decrease in patent, legal and accounting
related expenses, and the recognition of bad debt expense recorded
in the prior year period from Aclaris’ determination that
collection of amounts due from EPI Health are uncertain as a result
of their filing for Chapter 11 bankruptcy protection.
- Licensing expenses were $2.3 million for the six months ended
June 30, 2024 compared to $1.6 million for the prior year period.
The increase was due to an increase in royalties earned under the
Lilly license agreement.
- Revaluation of contingent consideration resulted in a $3.0
million loss for the six months ended June 30, 2024 compared to a
gain of $2.3 million for the prior year period.
OLUMIANT® is a registered trademark of Eli
Lilly and Company.
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 plans for its development programs, including its
plans to seek a development and commercialization partner for
lepzacitinib, the clinical development of ATI-2138, its plan to
support Washington University in St. Louis in its
investigator-initiated Phase 1b/2 trials of zunsemetinib, the
sufficiency of its cash, cash equivalents and marketable securities
to fund its operations into 2028, as well as its strategic plans
and strategic review. 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.Condensed Consolidated
Statements of Operations(unaudited, in thousands, except share and
per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
June 30, |
|
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
625 |
|
|
$ |
875 |
|
|
$ |
1,281 |
|
|
$ |
1,764 |
|
|
Licensing |
|
|
2,141 |
|
|
|
994 |
|
|
|
3,882 |
|
|
|
2,633 |
|
| Total
revenue |
|
|
2,766 |
|
|
|
1,869 |
|
|
|
5,163 |
|
|
|
4,397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Costs
and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue (1) |
|
|
624 |
|
|
|
1,042 |
|
|
|
1,433 |
|
|
|
1,850 |
|
|
Research and development (1) |
|
|
8,759 |
|
|
|
25,275 |
|
|
|
18,604 |
|
|
|
47,862 |
|
|
General and administrative (1) |
|
|
4,752 |
|
|
|
8,317 |
|
|
|
11,596 |
|
|
|
17,107 |
|
|
Licensing |
|
|
1,285 |
|
|
|
550 |
|
|
|
2,316 |
|
|
|
1,611 |
|
|
Revaluation of contingent consideration |
|
|
200 |
|
|
|
(1,500 |
) |
|
|
3,000 |
|
|
|
(2,300 |
) |
| Total
costs and expenses |
|
|
15,620 |
|
|
|
33,684 |
|
|
|
36,949 |
|
|
|
66,130 |
|
| Loss
from operations |
|
|
(12,854 |
) |
|
|
(31,815 |
) |
|
|
(31,786 |
) |
|
|
(61,733 |
) |
|
Other income, net |
|
|
1,868 |
|
|
|
2,246 |
|
|
|
3,859 |
|
|
|
4,004 |
|
| Net
loss |
|
$ |
(10,986 |
) |
|
$ |
(29,569 |
) |
|
$ |
(27,927 |
) |
|
$ |
(57,729 |
) |
| Net loss
per share, basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.84 |
) |
| Weighted
average common shares outstanding, basic and diluted |
|
|
71,291,400 |
|
|
|
70,633,528 |
|
|
|
71,183,129 |
|
|
|
68,763,542 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Cost of
revenue |
|
$ |
223 |
|
|
$ |
473 |
|
|
$ |
475 |
|
|
$ |
772 |
|
| Research
and development |
|
|
1,097 |
|
|
|
3,494 |
|
|
|
1,068 |
|
|
|
6,096 |
|
| General
and administrative |
|
|
1,583 |
|
|
|
2,555 |
|
|
|
3,449 |
|
|
|
6,460 |
|
| Total
stock-based compensation expense |
|
$ |
2,903 |
|
|
$ |
6,522 |
|
|
$ |
4,992 |
|
|
$ |
13,328 |
|
|
Aclaris Therapeutics, Inc.Selected Consolidated
Balance Sheet Data(unaudited, in thousands, except share data) |
|
|
|
|
|
|
|
|
|
| |
|
June 30, 2024 |
|
December 31, 2023 |
|
| |
|
|
|
|
|
|
|
| Cash,
cash equivalents and marketable securities |
|
$ |
149,871 |
|
$ |
181,877 |
|
| Total
assets |
|
$ |
161,071 |
|
$ |
197,405 |
|
| Total
current liabilities |
|
$ |
15,682 |
|
$ |
30,952 |
|
| Total
liabilities |
|
$ |
27,249 |
|
$ |
40,226 |
|
| Total
stockholders' equity |
|
$ |
133,822 |
|
$ |
157,179 |
|
| Common
stock outstanding |
|
|
71,332,825 |
|
|
70,894,889 |
|
|
Aclaris Therapeutics, Inc.Selected Consolidated
Cash Flow Data(unaudited, in thousands) |
| |
|
|
|
|
|
|
| |
|
Six Months EndedJune 30,
2024 |
|
Six Months EndedJune 30,
2023 |
| |
|
|
|
|
|
|
|
Net loss |
|
$ |
(27,927 |
) |
|
$ |
(57,729 |
) |
|
Depreciation and amortization |
|
|
485 |
|
|
|
416 |
|
|
Stock-based compensation expense |
|
|
4,992 |
|
|
|
13,328 |
|
|
Revaluation of contingent consideration |
|
|
3,000 |
|
|
|
(2,300 |
) |
| Changes
in operating assets and liabilities |
|
|
(13,687 |
) |
|
|
(722 |
) |
| Net cash
used in operating activities |
|
$ |
(33,137 |
) |
|
$ |
(47,007 |
) |
Aclaris Therapeutics
Contact:investors@aclaristx.com
Aclaris Therapeutics (NASDAQ:ACRS)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Aclaris Therapeutics (NASDAQ:ACRS)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024
