Aclaris Therapeutics Reports First Quarter 2023 Financial Results and Provides a Corporate Update
May 08 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 first quarter of 2023 and provided a
corporate update.
“The first quarter of 2023 represented another period of
continued progress advancing our clinical stage development
programs toward important data milestones,” stated Doug Manion,
M.D., Chief Executive Officer of Aclaris. “As we continue to move
toward data catalysts for zunsemetinib in rheumatoid arthritis and
psoriatic arthritis as well as ATI-1777 in atopic dermatitis, we
also are making positive progress towards bringing our next
potentially broadly applicable candidate, ATI-2138, into its first
proof of concept trial in ulcerative colitis.”
Continued Dr. Manion, “Regarding our proof-of-concept trial of
zunsemetinib in hidradenitis suppurativa, which we reported in
March, while we did not see positive efficacy results in this
particularly challenging disease, we were able to strengthen our
safety database and demonstrate mechanistically that our
potentially first-in-class MK2 inhibitor performed as
expected.”
Research and Development Highlights:
Clinical Development Programs:
- 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 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) is ongoing. Based on the continued
positive enrollment momentum, Aclaris is narrowing its timing
guidance for topline data to the fourth quarter of 2023.
- Psoriatic Arthritis (ATI-450-PsA-201): This
Phase 2a 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. Based on a
slower than anticipated study start up in Europe, the trial
enrollment has taken longer than expected. Based on current
enrollment trends and momentum, particularly in Poland, Aclaris now
expects topline data in the first half of 2024, rather than year
end 2023.
- ATI-1777, an investigational topical “soft”
Janus kinase (JAK) 1/3 inhibitor:Currently being developing as a
potential treatment for mild to severe atopic dermatitis (AD)
- Atopic Dermatitis (ATI-1777-AD-202): This
Phase 2b 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. In April 2023, Aclaris
modified the protocol to expand the inclusion criteria for the
trial to enroll patients with milder disease to broaden the drug’s
target indication potential and to further aide enrollment which
was challenged by an unexpected milder winter season. As a result,
Aclaris currently projects topline data in the second half of 2023,
rather than mid-year 2023.
- ATI-2138, an investigational oral covalent
ITK/JAK3 inhibitor: Currently being developed as a potential
treatment for T cell-mediated autoimmune diseases
- Aclaris has selected ulcerative colitis as the intended first
clinical development target for ATI-2138. Aclaris is also exploring
additional indications that are relevant to the mechanism of
action.
- Healthy Volunteers (ATI-2138-PKPD-102): This
Phase 1 MAD (multiple ascending dose) trial to investigate the
safety, tolerability, PK and PD of ATI-2138 in healthy volunteers
is ongoing. Aclaris continues to expect topline data in the second
half of 2023.
Preclinical Development Program
- 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
- Second MK2 inhibitor generated from Aclaris’ proprietary
KINect® drug discovery platform and designed to have a long plasma
half-life.
- Aclaris expects clinical development activities to be initiated
in 2023, which is expected to advance as a collaboration with an
academic third party.
Financial Highlights:
Liquidity and Capital Resources
As of March 31, 2023, Aclaris had aggregate cash, cash
equivalents and marketable securities of $204.4 million compared to
$229.8 million as of December 31, 2022.
Additionally, in March 2023, Aclaris issued a placement notice
to sell approximately 3.4 million shares under its ATM facility for
aggregate net proceeds of $26.7 million. This transaction closed in
April 2023.
Aclaris continues to anticipate that its cash, cash equivalents
and marketable securities as of March 31, 2023 in combination with
the $26.7 million in net proceeds from sales under the ATM facility
subsequent to quarter end, 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
First Quarter 2023
- Net loss was $28.2 million for the first quarter of 2023
compared to $18.8 million for the first quarter of 2022.
- Total revenue was $2.5 million for the first quarter of 2023
compared to $1.5 million for the first quarter of 2022. The
increase was driven by higher licensing revenue primarily from
royalties earned on out-licensed intellectual property in the first
quarter of 2023.
- Research and development (R&D) expenses were $22.6 million
for the quarter ended March 31, 2023 compared to $14.3 million for
the prior year period.
- The $8.3 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-1777 development expenses related to costs associated with
a Phase 2b clinical trial for AD.
- 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 $8.8 million
for the quarter ended March 31, 2023 compared to $6.1 million for
the prior year period. The increase was primarily due to an
increase in compensation-related expenses due to an increase in
headcount.
- Licensing expenses were $1.1 million for the quarter ended
March 31, 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
March 31, 2022.
- Revaluation of contingent consideration resulted in a $0.8
million credit for the quarter ended March 31, 2023 compared to a
credit of $1.2 million for the prior year period.
Conference Call and Webcast
As previously disclosed on May 2, 2023, management will host a
conference call and webcast, with an accompanying slide
presentation, at 8:00 AM ET today to provide a corporate update. To
access the live webcast of the call and the accompanying slide
presentation, please visit the “Events” page of the “Investors”
section of Aclaris’ website, www.aclaristx.com. The webcast will be
archived for at least 30 days on the Aclaris website.
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) |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
Contract research |
$ |
889 |
|
|
$ |
1,221 |
|
Licensing |
|
1,639 |
|
|
|
202 |
|
Other |
|
— |
|
|
|
30 |
|
Total revenue |
|
2,528 |
|
|
|
1,453 |
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
Cost of revenue (1) |
|
808 |
|
|
|
1,155 |
|
Research and development (1) |
|
22,587 |
|
|
|
14,306 |
|
General and administrative (1) |
|
8,790 |
|
|
|
6,099 |
|
Licensing |
|
1,061 |
|
|
|
— |
|
Revaluation of contingent consideration |
|
(800 |
) |
|
|
(1,200 |
) |
Total costs and expenses |
|
32,446 |
|
|
|
20,360 |
|
Loss from operations |
|
(29,918 |
) |
|
|
(18,907 |
) |
Other income, net |
|
1,758 |
|
|
|
118 |
|
Net loss |
$ |
(28,160 |
) |
|
$ |
(18,789 |
) |
Net loss per share, basic and
diluted |
$ |
(0.42 |
) |
|
$ |
(0.31 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
66,872,778 |
|
|
|
61,431,026 |
|
|
|
|
|
|
|
(1) Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
$ |
299 |
|
|
$ |
228 |
|
Research and development |
|
2,602 |
|
|
|
(113 |
) |
General and administrative |
|
3,905 |
|
|
|
2,231 |
|
Total stock-based compensation
expense |
$ |
6,806 |
|
|
$ |
2,346 |
|
Aclaris Therapeutics, Inc.Selected Consolidated
Balance Sheet Data(unaudited, in thousands, except share data) |
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
$ |
204,405 |
|
|
$ |
229,813 |
|
Total assets |
$ |
229,705 |
|
|
$ |
254,596 |
|
Total current liabilities |
$ |
18,258 |
|
|
$ |
21,938 |
|
Total liabilities |
$ |
52,895 |
|
|
$ |
56,975 |
|
Total stockholders' equity |
$ |
176,810 |
|
|
$ |
197,621 |
|
Common stock outstanding |
|
67,206,025 |
|
|
|
66,688,647 |
|
Aclaris Therapeutics, Inc.Selected Consolidated
Cash Flow Data(unaudited, in thousands) |
|
|
|
|
|
|
|
Three Months EndedMarch 31,
2023 |
|
Three Months EndedMarch 31,
2022 |
|
|
|
|
|
|
Net loss |
$ |
(28,160 |
) |
|
$ |
(18,789 |
) |
Depreciation and
amortization |
|
198 |
|
|
|
208 |
|
Stock-based compensation
expense |
|
6,806 |
|
|
|
2,346 |
|
Revaluation of contingent
consideration |
|
(800 |
) |
|
|
(1,200 |
) |
Changes in operating assets and
liabilities |
|
(4,397 |
) |
|
|
(3,534 |
) |
Net cash used in operating
activities |
$ |
(26,353 |
) |
|
$ |
(20,969 |
) |
Aclaris Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
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