Aclaris Therapeutics Reports Second Quarter 2023 Financial Results and Provides a Corporate Update
August 07 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 second quarter of 2023 and provided a
corporate update.
“During the second quarter of this year, we continued to make
positive strides across our clinical development pipeline, most
notably through the completion of enrollment in our Phase 2b trial
of zunsemetinib in patients with rheumatoid arthritis, which
positions that trial to be our next Phase 2 data read-out,” stated
Doug Manion, M.D., Chief Executive Officer of Aclaris. “The next
several quarters are lining up well with data read-outs for each of
our clinical stage development therapeutics, all created by our
KINect® drug discovery platform.”
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 subjects
with moderate to severe rheumatoid arthritis (RA) completed
enrollment in June 2023. Aclaris continues to expect topline data
in the fourth quarter of 2023.
- 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 subjects 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 subjects with mild to severe AD is ongoing.
Aclaris continues to expect topline data in the second half 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 a preliminary analysis of
the PK, PD and safety, Aclaris believes the data support the
progression of ATI-2138 into Phase 2 clinical development in
ulcerative colitis. Aclaris expects to report the data in September
2023.
- 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
- 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 June 30, 2023, Aclaris had aggregate cash, cash
equivalents and marketable securities of $210.8 million compared to
$229.8 million as of December 31, 2022. Aggregate cash, cash
equivalents and marketable securities as of June 30, 2023 included
$26.7 million of net proceeds from the sale of 3.4 million shares
under its ATM facility in April 2023.
Aclaris continues to anticipate that its cash, cash equivalents
and marketable securities as of June 30, 2023 will be sufficient to
fund its operations through the end of 2025, without giving effect
to any potential business development transactions or additional
financing activities.
Financial Results
Second Quarter 2023
- Net loss was $29.6 million for the second quarter of 2023
compared to $20.5 million for the second quarter of 2022.
- Total revenue was $1.9 million for the second quarter of 2023
compared to $1.5 million for the second quarter of 2022. The
increase was driven by higher licensing revenue primarily from
royalties earned on out-licensed intellectual property.
- Research and development (R&D) expenses were $25.3 million
for the quarter ended June 30, 2023 compared to $18.8 million for
the prior year period.
- The $6.5 million increase was primarily the result of higher:
- Zunsemetinib development expenses related to drug candidate
manufacturing and costs associated with clinical activities for a
Phase 2b trial for RA.
- ATI-2138 development expenses, including costs associated with
a Phase 1 MAD trial and other preclinical activities.
- Compensation-related expenses due to an increase in
headcount.
- General and administrative (G&A) expenses were $8.3 million
for the quarter ended June 30, 2023 compared to $6.1 million for
the prior year period. The increase was primarily due to 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. Compensation-related
expenses also increased due to an increase in headcount.
- Licensing expenses were $0.6 million for the quarter ended June
30, 2023 resulting from separate third-party contractual
obligations related to the non-exclusive patent license agreement
with Lilly. There were no licensing expenses for the quarter ended
June 30, 2022.
- Revaluation of contingent consideration resulted in a $1.5
million gain for the quarter ended June 30, 2023 compared to a gain
of $3.4 million for the prior year period.
Year-to-date 2023
- Net loss was $57.7 million for the six months ended June 30,
2023 compared to $39.3 million for the six months ended June 30,
2022.
- Total revenue was $4.4 million for the six months ended June
30, 2023 compared to $3.0 million for the six months ended June 30,
2022.
- R&D expenses were $47.9 million for the six months ended
June 30, 2023 compared to $33.1 million for the prior year period.
- The $14.8 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.
- Compensation-related expenses due to an increase in
headcount.
- G&A expenses were $17.1 million for the six months ended
June 30, 2023 compared to $12.2 million for the prior year period.
- The $4.9 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 six months ended June 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 $2.3
million gain for the six months ended June 30, 2023 compared to a
gain of $4.6 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, 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)
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Three Months Ended |
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Six Months Ended |
|
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June 30, |
|
June 30, |
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|
2023 |
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2022 |
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2023 |
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2022 |
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Revenues: |
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Contract research |
|
$ |
875 |
|
|
$ |
1,218 |
|
|
$ |
1,764 |
|
|
$ |
2,439 |
|
Licensing |
|
|
994 |
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|
|
280 |
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|
2,633 |
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|
481 |
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Other |
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- |
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|
30 |
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- |
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|
61 |
|
Total revenue |
|
|
1,869 |
|
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|
1,528 |
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|
4,397 |
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|
2,981 |
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Costs and expenses: |
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Cost of revenue (1) |
|
|
1,042 |
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|
1,068 |
|
|
|
1,850 |
|
|
|
2,223 |
|
Research and development (1) |
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25,275 |
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18,779 |
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|
47,862 |
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|
|
33,085 |
|
General and administrative (1) |
|
|
8,317 |
|
|
|
6,075 |
|
|
|
17,107 |
|
|
|
12,174 |
|
Licensing |
|
|
550 |
|
|
|
- |
|
|
|
1,611 |
|
|
|
- |
|
Revaluation of contingent consideration |
|
|
(1,500 |
) |
|
|
(3,400 |
) |
|
|
(2,300 |
) |
|
|
(4,600 |
) |
Total costs and expenses |
|
|
33,684 |
|
|
|
22,522 |
|
|
|
66,130 |
|
|
|
42,882 |
|
Loss from operations |
|
|
(31,815 |
) |
|
|
(20,994 |
) |
|
|
(61,733 |
) |
|
|
(39,901 |
) |
Other income, net |
|
|
2,246 |
|
|
|
462 |
|
|
|
4,004 |
|
|
|
580 |
|
Net loss |
|
$ |
(29,569 |
) |
|
$ |
(20,532 |
) |
|
$ |
(57,729 |
) |
|
$ |
(39,321 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.62 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
70,633,528 |
|
|
|
65,990,031 |
|
|
|
68,763,542 |
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63,723,123 |
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(1) Amounts include stock-based compensation expense as
follows: |
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Cost of revenue |
|
$ |
473 |
|
|
$ |
302 |
|
|
$ |
772 |
|
|
$ |
530 |
|
Research and development |
|
|
3,494 |
|
|
|
941 |
|
|
|
6,096 |
|
|
|
828 |
|
General and
administrative |
|
|
2,555 |
|
|
|
2,449 |
|
|
|
6,460 |
|
|
|
4,680 |
|
Total stock-based compensation
expense |
|
$ |
6,522 |
|
|
$ |
3,692 |
|
|
$ |
13,328 |
|
|
$ |
6,038 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Balance Sheet Data(unaudited, in
thousands, except share data)
|
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June 30, 2023 |
|
December 31, 2022 |
|
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Cash, cash equivalents and
marketable securities |
|
$ |
210,767 |
|
$ |
229,813 |
|
Total assets |
|
$ |
235,649 |
|
$ |
254,596 |
|
Total current liabilities |
|
$ |
22,829 |
|
$ |
21,938 |
|
Total liabilities |
|
$ |
55,899 |
|
$ |
56,975 |
|
Total stockholders'
equity |
|
$ |
179,750 |
|
$ |
197,621 |
|
Common stock outstanding |
|
|
70,769,702 |
|
|
66,688,647 |
|
Aclaris Therapeutics,
Inc.Selected Consolidated Cash Flow Data(unaudited, in
thousands)
|
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Six Months EndedJune 30,
2023 |
|
Six Months EndedJune 30,
2022 |
|
|
|
|
|
|
Net loss |
$ |
(57,729 |
) |
|
$ |
(39,321 |
) |
Depreciation and
amortization |
|
416 |
|
|
|
414 |
|
Stock-based compensation
expense |
|
13,328 |
|
|
|
6,038 |
|
Revaluation of contingent
consideration |
|
(2,300 |
) |
|
|
(4,600 |
) |
Changes in operating assets and
liabilities |
|
(722 |
) |
|
|
(3,166 |
) |
Net cash used in operating
activities |
$ |
(47,007 |
) |
|
$ |
(40,635 |
) |
Aclaris Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
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