Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update
08 November 2022 - 11:00PM
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 third quarter of 2022 and provided a
corporate update.
“The third quarter of this year marked another period of
important milestone achievement - the successful completion of
enrollment in the Phase 2a trial of zunsemetinib in hidradenitis
suppurativa,” said Dr. Neal Walker, Chief Executive Officer of
Aclaris. “We also recently successfully completed the Phase 1 SAD
trial for ATI-2138. We are very pleased with the results from the
Phase 1 SAD trial which we believe support us proceeding to a
multiple ascending dose (MAD) trial. Additionally, we have selected
ulcerative colitis as the first target indication for ATI-2138
given the compelling pre-clinical profile and high medical need
that persists for this debilitating disease.”
Research and Development Highlights:
Clinical 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. Aclaris expects topline data
in the second half of 2023.
- Hidradenitis Suppurativa (ATI-450-HS-201):
This Phase 2a trial to investigate the efficacy, safety,
tolerability, PK and PD of zunsemetinib (50 mg twice daily) over 12
weeks in subjects with moderate to severe hidradenitis suppurativa
(HS) has completed enrollment with 95 patients randomized and is
ongoing. Aclaris expects topline data in mid-first half 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. Aclaris
expects topline data in the second half of 2023.
- ATI-1777, an investigational topical “soft”
Janus kinase (JAK) 1/3 inhibitor:Currently being developing as a
potential treatment for moderate to severe atopic dermatitis (AD)
- Atopic Dermatitis (ATI-1777-AD-202): This
Phase 2b trial to determine the efficacy, safety, tolerability, and
PK of ATI-1777 in subjects with moderate to severe AD is ongoing.
Aclaris continues to expect topline data in the first half of
2023.
- ATI-2138, an investigational oral covalent
ITK/TXK/JAK3 (ITJ) inhibitor:Currently being developed as a
potential treatment for T cell-mediated autoimmune diseases
- ATI-2138-PKPD-101: This Phase 1 first-in-human
randomized, observer-blind, placebo-controlled single ascending
dose (SAD) trial to investigate the safety, tolerability, PK and PD
of ATI-2138 in healthy subjects is complete.
- The primary objective was to assess the safety and tolerability
of ATI-2138. Secondary endpoints included the assessment of PK,
including the effect of food. The study also explored the PD
response to ATI-2138. An additional cohort compared the capsule
formulation to a tablet formulation.
- Sixty-four male and female healthy volunteer subjects were
randomized 3:1 into seven doses in eight cohorts. Each cohort
consisted of eight randomized subjects (ATI-2138: n=6; placebo:
n=2). Single dose levels were 1 mg, 3 mg, 5 mg, 15 mg, 25 mg,
50 mg, and 80 mg.
- Preliminary data:
- ATI-2138 was generally well tolerated at all doses tested in
the trial. No serious adverse events or severe adverse events were
reported. The most common adverse events in subjects treated with
ATI-2138, headache (four subjects) and lightheadedness (two
subjects), were mild and transient.
- ATI-2138 demonstrated linear PK data and absorption with a
favorable PK profile up to the 80 mg single dose.
- There was no significant food effect at 15 mg (fasted versus
fed) observed.
- Similar PK was observed with the capsule versus tablet
formulations at 25 mg.
- Dose-dependent inhibition of both ITK and JAK3 exploratory PD
biomarkers was observed; near complete inhibition of the dual ITK
and JAK3-stimulated interferon production was observed at the 15 mg
through 80 mg doses.
- 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.
- Aclaris submitted a new IND for this program to the U.S. Food
and Drug Administration’s (FDA) Gastroenterology Division in
October 2022 for the treatment of ulcerative colitis. If allowed,
Aclaris intends to initiate a Phase 1 MAD trial of ATI-2138 in
healthy subjects by the end of 2022.
Preclinical Programs
- 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
half-life.
- IND-enabling studies are underway, and Aclaris expects to
submit an IND by the end of 2022.
Financial Highlights:
Liquidity and Capital Resources
As of September 30, 2022, Aclaris had aggregate cash, cash
equivalents and marketable securities of $248.1 million compared to
$225.7 million as of December 31, 2021. Aggregate cash, cash
equivalents and marketable securities as of September 30, 2022
included proceeds received during the quarter under a non-exclusive
patent license agreement with Eli Lilly and Company (Lilly). Under
the non-exclusive patent license agreement, Aclaris granted Lilly
non-exclusive rights under certain patents and patent applications
for the use of baricitinib, Lilly’s JAK inhibitor, to treat
alopecia areata. Aclaris exclusively licenses patents and patents
applications from a third party relating to the use of JAK
inhibitors to induce hair growth and treat hair loss disorders.
Aclaris continues to anticipate that its cash, cash equivalents
and marketable securities as of September 30, 2022 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 2022
- Net loss was $20.0 million for the third quarter of 2022
compared to $21.1 million for the third quarter of 2021.
- Total revenue was $19.0 million for the third quarter of 2022
compared to $1.7 million for the third quarter of 2021. The
increase was driven by $17.9 million of licensing revenue in the
quarter, including $17.6 million from the non-exclusive patent
license agreement with Lilly.
- Research and development (R&D) expenses were $23.7 million
for the quarter ended September 30, 2022 compared to $14.0 million
for the prior year period.
- The $9.7 million increase was primarily the result of higher:
- Zunsemetinib development expenses, including costs associated
with clinical activities for a Phase 2b trial for RA, a Phase 2a
trial for HS, and a Phase 2a trial for PsA.
- ATI-1777 development expenses related to drug candidate
manufacturing and other preclinical activities and costs associated
with a Phase 2b clinical trial for AD.
- IND submission preparation and preclinical development
activities related to ATI-2231.
- Compensation-related expenses due to an increase in
headcount.
- General and administrative (G&A) expenses were $5.8 million
for the quarter ended September 30, 2022 compared to $6.0 million
for the prior year period.
- Licensing expenses were $7.3 million for the quarter ended
September 30, 2022, 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
September 30, 2021.
- Revaluation of contingent consideration was $2.2 million for
the quarter ended September 30, 2022, compared to a revaluation of
contingent consideration expense of $0.9 million for the prior year
period.
Year-to-date 2022
- Net loss was $59.3 million for the nine months ended September
30, 2022 compared to $68.1 million for the nine months ended
September 30, 2021.
- Total revenue was $22.0 million for the nine months ended
September 30, 2022 compared to $5.3 million for the nine months
ended September 30, 2021. The increase was driven by $18.4 million
of licensing revenue in 2022, including $17.6 million from the
non-exclusive patent license agreement with Lilly.
- R&D expenses were $56.7 million for the nine months ended
September 30, 2022 compared to $29.7 million for the prior year
period.
- The $27.0 million increase was primarily the result of higher:
- Zunsemetinib development expenses, including costs associated
with clinical activities for a Phase 2b trial for RA, a Phase 2a
trial for HS, and a Phase 2a trial for PsA.
- ATI-1777 development expenses related to drug candidate
manufacturing and other preclinical activities and costs associated
with a Phase 2b clinical trial for AD.
- IND submission preparation and preclinical development
activities related to ATI-2231.
- Compensation-related expenses due to an increase in
headcount.
- G&A expenses were $18.0 million for the nine months ended
September 30, 2022 compared to $16.7 million for the prior year
period.
- The $1.3 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, 2022.
- Licensing expenses were $7.3 million for the nine months ended
September 30, 2022 resulting from separate third-party contractual
obligations related to the non-exclusive patent license agreement
with Lilly. There were no licensing expenses for the nine months
ended September 30, 2021.
- Revaluation of contingent consideration resulted in a $2.4
million reduction of expense for the nine months ended September
30, 2022, compared to a revaluation of contingent consideration
expense of $22.1 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 COVID-19 pandemic 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,
2021, 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, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Contract research |
|
$ |
1,090 |
|
$ |
1,415 |
|
$ |
3,529 |
|
$ |
4,556 |
Licensing |
|
|
17,898 |
|
|
214 |
|
|
18,378 |
|
|
612 |
Other |
|
|
30 |
|
|
30 |
|
|
92 |
|
|
92 |
Total revenue |
|
|
19,018 |
|
|
1,659 |
|
|
21,999 |
|
|
5,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue(1) |
|
|
923 |
|
|
1,099 |
|
|
3,146 |
|
|
3,564 |
Research and development(1) |
|
|
23,656 |
|
|
13,976 |
|
|
56,741 |
|
|
29,711 |
General and administrative(1) |
|
|
5,813 |
|
|
5,979 |
|
|
17,987 |
|
|
16,676 |
Licensing |
|
|
7,300 |
|
|
— |
|
|
7,300 |
|
|
— |
Revaluation of contingent consideration |
|
|
2,200 |
|
|
900 |
|
|
(2,400) |
|
|
22,139 |
Total costs and expenses |
|
|
39,892 |
|
|
21,954 |
|
|
82,774 |
|
|
72,090 |
Loss from operations |
|
|
(20,874) |
|
|
(20,295) |
|
|
(60,775) |
|
|
(66,830) |
Other income (expense), net |
|
|
922 |
|
|
(851) |
|
|
1,502 |
|
|
(1,231) |
Net loss |
|
$ |
(19,952) |
|
$ |
(21,146) |
|
$ |
(59,273) |
|
$ |
(68,061) |
Net loss per share, basic and
diluted |
|
$ |
(0.30) |
|
$ |
(0.35) |
|
$ |
(0.92) |
|
$ |
(1.23) |
Weighted average common shares
outstanding, basic and diluted |
|
|
66,675,337 |
|
|
61,219,321 |
|
|
64,718,008 |
|
|
55,215,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)Amounts include stock-based compensation expense as
follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
307 |
|
$ |
206 |
|
$ |
837 |
|
$ |
787 |
Research and development |
|
|
1,400 |
|
|
939 |
|
|
2,228 |
|
|
2,969 |
General and
administrative |
|
|
2,481 |
|
|
2,557 |
|
|
7,161 |
|
|
6,453 |
Total stock-based compensation
expense |
|
$ |
4,188 |
|
$ |
3,702 |
|
$ |
10,226 |
|
$ |
10,209 |
Aclaris Therapeutics, Inc.Selected Consolidated
Balance Sheet Data(unaudited, in thousands, except share data) |
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
248,062 |
|
$ |
225,656 |
Total assets |
|
$ |
267,632 |
|
$ |
251,211 |
Total current liabilities |
|
$ |
19,789 |
|
$ |
22,931 |
Total liabilities |
|
$ |
47,794 |
|
$ |
53,870 |
Total stockholders'
equity |
|
$ |
219,838 |
|
$ |
197,341 |
Common stock outstanding |
|
|
66,679,641 |
|
|
61,228,446 |
Aclaris Therapeutics, Inc.Selected Consolidated
Cash Flow Data(unaudited, in thousands) |
|
|
Nine Months Ended September 30,
2022 |
|
Nine Months Ended September 30,
2021 |
|
|
|
|
|
|
|
Net loss |
|
$ |
(59,273) |
|
$ |
(68,061) |
Depreciation and
amortization |
|
|
607 |
|
|
726 |
Stock-based compensation
expense |
|
|
10,226 |
|
|
10,209 |
Revaluation of contingent
consideration |
|
|
(2,400) |
|
|
22,139 |
Loss on extinguishment of
debt |
|
|
— |
|
|
752 |
Changes in operating assets
and liabilities |
|
|
2,388 |
|
|
(824) |
Net cash used in operating
activities |
|
$ |
(48,452) |
|
$ |
(35,059) |
|
|
|
|
|
|
|
Aclaris Therapeutics Contact:
Robert A. Doody Jr.Vice President, Investor
Relations484-639-7235rdoody@aclaristx.com
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