Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing meaningful
innovations to address the urgent needs of patients living with
immune-mediated dermatological diseases and conditions, or
immuno-dermatology, today reported financial results for the
quarter ended June 30, 2021, and provided a business update.
“We are on track to submit our plaque psoriasis
NDA to the FDA soon, based on the strongly positive pivotal Phase 3
results reported in February. We have also initiated, or are on the
cusp of initiating, three more Phase 3 programs of topical
roflumilast, with multiple top-line readouts in 2022,” said Frank
Watanabe, Arcutis’ President and Chief Executive Officer. “We
continue to add top talent to our team, as our strong financial
position allows us to build out key capabilities to ensure we are
ready to launch topical roflumilast, pending FDA approval, and to
maximize the potential of our medicines for patients,
dermatologists, and shareholders. The significant progress made at
Arcutis in the first half of 2021 positions us well for an exciting
next 18 months.”
Pipeline Updates
Roflumilast cream - a highly
potent and selective phosphodiesterase type 4 (PDE4) inhibitor in a
cream formulation, being developed as a potential treatment for
plaque psoriasis, including intertriginous psoriasis, and atopic
dermatitis.
- Arcutis anticipates
submitting an NDA for plaque psoriasis to the U.S. Food and Drug
Administration (FDA) late in the third quarter or early in the
fourth quarter of 2021, based on the positive results from two
pivotal Phase 3 clinical trials (DERMIS-1 and DERMIS-2).
- Patient enrollment continues in the
pivotal Phase 3 trials in patients with atopic dermatitis
(INTEGUMENT-1, INTEGUMENT-2, and INTEGUMENT-PED), with topline data
anticipated in the second half of 2022.
Roflumilast foam - an alternative formulation
of topical roflumilast designed to overcome the challenges of
delivering topical drugs in hair-bearing areas of the body, being
developed as a potential treatment for seborrheic dermatitis and
scalp psoriasis.
- In July, Arcutis announced the
initiation of a single pivotal Phase 3 trial for the treatment of
seborrheic dermatitis, with topline data anticipated in the second
or third quarter of 2022. If positive, the Company expects the data
to be sufficient basis for an NDA.
- The Company anticipates initiating a
single pivotal Phase 3 trial for the treatment of scalp and body
psoriasis in Q3 2021, with topline data anticipated in the second
half of 2022. If positive, the Company expects the data to be
sufficient basis for an NDA.
ARQ-252 - a topical small molecule
inhibitor of Janus kinase type 1 (JAK1), being developed as a
potential treatment for chronic hand eczema, vitiligo, and other
inflammatory dermatoses.
- In May, Arcutis announced that the
Phase 2 study of ARQ-252 in chronic hand eczema did not meet its
primary endpoint of Investigator Global Assessment (IGA) of clear
or almost clear at week 12. Further analyses of the study pointed
toward inadequate local drug delivery to the skin as a key driver
of the lack of efficacy. Importantly, no safety or tolerability
issues were seen.
- In July, the Company announced the
termination of the Phase 2a clinical trial evaluating ARQ-252 as a
potential treatment for vitiligo, based on the aforementioned
analyses of the Phase 2 chronic hand eczema study.
- The Company continues its reformulation
efforts to develop an enhanced formulation of ARQ-252 that delivers
more active drug to targets in the skin.
ARQ-255 - an alternative topical
formulation of ARQ-252 designed to reach deeper into the
skin in order to potentially treat alopecia areata.
- Formulation and
preclinical efforts are continuing.
Recent Corporate Highlights
- Sue-Jean Lin was appointed to Arcutis’ Board of Directors
- Raj Madan was appointed Senior Vice President and Chief Digital
and Information Officer
- Greg Sukay joined the Company as Vice President of
Manufacturing and Process Technologies
Second Quarter 2021 Summary Financial
Results
Cash, cash equivalents, restricted cash,
and marketable securities were $410.9 million as of
June 30, 2021, compared to $286.0 million as of
December 31, 2020. Arcutis believes that its current cash,
cash equivalents, and marketable securities will be sufficient to
fund its operations well into 2023.
Research and development (R&D)
expenses for the quarter ended June 30, 2021
were $30.8 million compared to $30.0 million for the corresponding
period in 2020. R&D expenses for the six months ended June 30,
2021 were $52.4 million compared to $55.2 million for the
corresponding period in 2020. The year-over-year increase for the
quarter ended June 30, 2021 was primarily due to increased
clinical costs for the Phase 3 studies of topical roflumilast in
atopic dermatitis, seborrheic dermatitis, and scalp psoriasis and
the Phase 2 study of ARQ-252 in vitiligo, mostly offset by
completion of the Phase 3 studies of roflumilast cream in plaque
psoriasis and Phase 2 studies of roflumilast foam in seborrheic
dermatitis and scalp psoriasis. The year-over-year decrease for the
six months ended June 30, 2021 was primarily due to the completion
of the Phase 3 studies of roflumilast cream in plaque psoriasis and
Phase 2 studies of roflumilast foam in seborrheic dermatitis and
scalp psoriasis, offset partially by increased clinical costs for
the Phase 3 studies of topical roflumilast in atopic dermatitis,
seborrheic dermatitis, and scalp psoriasis, and the Phase 2 study
of ARQ-252 in vitiligo.
General and administrative (G&A)
expenses for the quarter ended June 30, 2021
were $11.3 million compared to $5.6 million for the corresponding
period in 2020. G&A expenses for the six months ended June 30,
2021 were $25.8 million compared to $9.1 million for the
corresponding period in 2020. These year-over-year increases were
primarily due to higher headcount and professional services costs.
First half 2021 G&A expenses were also impacted by a one-time
$5.3 million non-cash charge for modifications to previously
granted stock awards in connection with an officer's
retirement.
Net loss was $42.0
million, or $0.84 per basic and diluted share, for the quarter
ended June 30, 2021 compared to $35.4 million, or $0.94 per
basic and diluted share, for the corresponding period in 2020. Net
loss was $78.1 million, or $1.60 per basic and diluted share, for
the six months ended June 30, 2021 compared to $63.4 million, or
$2.05 per basic and diluted share, for the corresponding period in
2020.
About Arcutis - Bioscience, applied to the
skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is
a medical dermatology company that champions meaningful innovation
to address the urgent needs of patients living with immune-mediated
dermatological diseases and conditions. With a commitment to
solving the most persistent patient challenges in dermatology,
Arcutis harnesses our unique dermatology development platform
coupled with our dermatology expertise to build differentiated
therapies against biologically validated targets. Arcutis’
dermatology development platform includes a robust pipeline with
seven clinical programs for a range of inflammatory dermatological
conditions, with our first NDA submission anticipated late in the
third quarter or early in the fourth quarter of 2021 and three more
Phase 3 clinical data readouts anticipated over the next 18 months.
The company’s lead product candidate, topical roflumilast, has the
potential to advance the standard of care for plaque psoriasis,
atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For
more information, visit https://www.arcutis.com or follow the
company on LinkedIn and Twitter.
Forward Looking Statements
This press release contains "forward-looking"
statements, including, among others, statements regarding the
potential for its topical drugs in development to address large
markets with significant unmet need; expectations with regard to
the timing of data events anticipated during 2021/2022; and the
Company’s belief that its current cash, cash equivalents, and
marketable securities, including the net proceeds from its recent
financing, will be sufficient to fund its operations into 2023.
These statements involve substantial known and unknown risks,
uncertainties and other factors that may cause our actual results,
levels of activity, performance, or achievements to be materially
different from the information expressed or implied by these
forward-looking statements and you should not place undue reliance
on our forward-looking statements. Risks and uncertainties that may
cause our actual results to differ include risks inherent in the
clinical development process and regulatory approval process, the
timing of regulatory filings, and our ability to defend our
intellectual property. For a further description of the risks and
uncertainties applicable to our business, see the “Risk Factors”
section of our Form 10-K filed with U.S. Securities and
Exchange Commission (SEC) on February 16, 2021, as well as any
subsequent filings with the SEC. We undertake no obligation to
revise or update information herein to reflect events or
circumstances in the future, even if new information becomes
available.
Contacts:
MediaAmanda Sheldon, Head of Corporate
Communicationsasheldon@arcutis.com
InvestorsEric McIntyre, Head of Investor
Relationsemcintyre@arcutis.com
|
|
ARCUTIS BIOTHERAPEUTICS, INC.Condensed
Balance Sheets(In thousands) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
89,128 |
|
|
$ |
65,082 |
|
Restricted cash |
1,542 |
|
|
1,542 |
|
Marketable securities |
320,236 |
|
|
219,359 |
|
Prepaid expenses and other current assets |
16,648 |
|
|
6,843 |
|
Total current assets |
427,554 |
|
|
292,826 |
|
Property and equipment,
net |
2,069 |
|
|
2,016 |
|
Operating lease right-of-use
asset |
3,191 |
|
|
3,349 |
|
Other assets |
78 |
|
|
78 |
|
Total assets |
$ |
432,892 |
|
|
$ |
298,269 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,676 |
|
|
$ |
7,140 |
|
Accrued liabilities |
10,565 |
|
|
15,462 |
|
Operating lease liability |
106 |
|
|
— |
|
Total current liabilities |
13,347 |
|
|
22,602 |
|
Operating lease liability,
noncurrent |
5,032 |
|
|
4,964 |
|
Other long-term
liabilities |
25 |
|
|
82 |
|
Total liabilities |
18,404 |
|
|
27,648 |
|
Stockholders’ equity: |
|
|
|
Common stock |
5 |
|
|
4 |
|
Additional paid-in capital |
694,519 |
|
|
472,569 |
|
Accumulated other comprehensive loss |
(36 |
) |
|
(2 |
) |
Accumulated deficit |
(280,000 |
) |
|
(201,950 |
) |
Total stockholders’ equity |
414,488 |
|
|
270,621 |
|
Total liabilities and
stockholders’ equity |
$ |
432,892 |
|
|
$ |
298,269 |
|
|
|
|
|
|
|
|
|
ARCUTIS BIOTHERAPEUTICS, INC. |
|
Condensed Statements of Operations and Comprehensive
Loss(In thousands, except share and per share
data)(unaudited) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
30,765 |
|
|
$ |
30,009 |
|
|
$ |
52,396 |
|
|
$ |
55,191 |
|
General and administrative |
11,315 |
|
|
5,618 |
|
|
25,769 |
|
|
9,087 |
|
Total operating expenses |
42,080 |
|
|
35,627 |
|
|
78,165 |
|
|
64,278 |
|
Loss from operations |
(42,080 |
) |
|
(35,627 |
) |
|
(78,165 |
) |
|
(64,278 |
) |
Other income, net |
72 |
|
|
215 |
|
|
115 |
|
|
853 |
|
Net loss |
$ |
(42,008 |
) |
|
$ |
(35,412 |
) |
|
$ |
(78,050 |
) |
|
$ |
(63,425 |
) |
Per share information: |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.84 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.60 |
) |
|
$ |
(2.05 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
50,000,716 |
|
|
37,587,330 |
|
|
48,648,262 |
|
|
30,921,866 |
|
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