Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage
biopharmaceutical company focused on developing and commercializing
treatments for unmet needs in immune-mediated dermatological
diseases and conditions, or immuno-dermatology, today reported
financial results for the quarter ended June 30, 2020, and
provided a business update.
“Arcutis is uniquely positioned to fill the
innovation gap in the medical dermatology sector, and we anticipate
six important clinical data readouts, including our pivotal Phase 3
clinical trials of topical roflumilast cream as a potential
treatment for plaque psoriasis, between now and the end of 2021,”
said Frank Watanabe, Arcutis’ President and Chief Executive
Officer. “Dermatologists and patients are desperate for new topical
options to treat serious diseases of the skin. We are focused on
elevating the standard of care for dermatological diseases and
conditions through novel therapies that simplify disease management
for physicians and eliminate the need for patients to compromise
between drug safety, efficacy, and tolerability. We appreciate the
strong support from investigators across our development programs,
which currently include four product candidates in development for
seven indications, with an addressable U.S. market of over 20
million patients.”
Pipeline Update
ARQ-151 (Topical 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.
- The New England Journal of Medicine published positive results
from a Phase 2b trial, which demonstrated the compound
significantly improves chronic plaque psoriasis.
- Topline data from two on-going Phase 3 clinical trials
(DERMIS-1 and-2) in patients with plaque psoriasis is anticipated
in the first half of 2021.
- On-going Phase 2 long-term safety study in plaque
psoriasis has completed enrollment, with topline data anticipated
in the first quarter of 2021.
- The Company expects to begin a Phase 2b study in atopic
dermatitis in the second half of 2020, with topline data
anticipated in the second half of 2021.
ARQ-154 (Topical roflumilast foam) - a
highly potent and selective phosphodiesterase type 4 (PDE4)
inhibitor in a foam formulation, 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 June, the Company completed enrollment in the on-going Phase
2 proof-of-concept study in seborrheic dermatitis, with topline
data anticipated early in the fourth quarter of 2020.
- In July, the Company completed enrollment in the ongoing Phase
2b study in scalp psoriasis, with topline data anticipated in the
fourth quarter of 2020.
ARQ-252 - a potent and highly selective
topical small molecule inhibitor of Janus kinase type 1 (JAK1),
being developed as a potential treatment for chronic hand eczema
and other inflammatory dermatoses.
- In July, the Company initiated enrollment in the Phase 2b
portion of the ongoing Phase 1/2b study in chronic hand eczema,
with topline data anticipated in the second half of 2021.
- The Company anticipates initiating a Phase 2a study in vitiligo
in the second half of 2020.
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 underway.
Recent Corporate Highlights
- Over the course of the second quarter, the Company announced
that two senior executives had joined the Company:
- Jay Ramsinghani, Vice President of Commercial Strategy and
Operations.
- Ayisha Jeter, Vice President of Market Access.
Second Quarter 2020 Summary Financial
Results
Cash, cash equivalents and marketable
securities were $224.0 million as of June 30,
2020, compared to $101.3 million as of December 31, 2019.
Arcutis believes that its current cash, cash equivalents, and
marketable securities will be sufficient to fund its operations
through 2021.
Research and development (R&D)
expenses for the quarter ended June 30, 2020
were $30.0 million compared to $7.2 million for the
corresponding period in 2019. R&D expenses for the six months
ended June 30, 2020 were $55.2 million compared to $13.4 million
for the corresponding period in 2019. These year-over-year
increases were primarily due to the initiation of multiple clinical
trials during the last year.
General and administrative (G&A)
expenses for the quarter ended June 30, 2020
were $5.6 million compared to $1.3 million for the
corresponding period in 2019. G&A expenses for the six months
ended June 30, 2020 were $9.1 million compared to $2.1 million for
the corresponding period in 2019. These year-over-year increases
were primarily due to higher headcount and professional services
costs, including the costs associated with being a public
company.
Net loss was
$35.4 million, or $0.94 per basic and diluted share, for the
quarter ended June 30, 2020 compared to $8.3 million, or
$4.69 per basic and diluted share, for the corresponding period in
2019. Net loss was $63.4 million, or $2.05 per basic and
diluted share, for the six months ended June 30, 2020 compared to
$14.9 million, or $8.79 per basic and diluted share, for the
corresponding period in 2019.
About Arcutis - Bioscience, applied to the
skin.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is
a late-stage biopharmaceutical company focused on developing and
commercializing treatments for unmet needs in immune-mediated
dermatological diseases and conditions, or immuno-dermatology. The
Company is leveraging recent advances in immunology and
inflammation to develop differentiated therapies against
biologically validated targets to solve persistent treatment
challenges in serious diseases of the skin. Arcutis’ robust
pipeline includes four novel drug candidates currently in
development for a range of inflammatory dermatological conditions.
The Company’s lead product candidate, topical roflumilast, has the
potential to revitalize the standard of care for plaque psoriasis,
atopic dermatitis, scalp psoriasis, and seborrheic
dermatitis. For more information, visit 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 2020/2021; and the Company’s belief
that its current cash, cash equivalents and marketable securities
will be sufficient to fund its
operations through 2021. 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-Q filed with U.S.
Securities and Exchange Commission (SEC) on August 11, 2020, 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.
Contact:Heather Rowe Armstrong Vice President,
Investor Relations & Corporate
Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740
ARCUTIS BIOTHERAPEUTICS,
INC.Condensed Balance Sheets(In
thousands, except share and par value)
|
June 30, |
|
December 31, |
|
2020 |
|
2019 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
171,546 |
|
|
$ |
63,336 |
|
Marketable securities |
52,429 |
|
|
37,929 |
|
Prepaid expenses and other current assets |
4,060 |
|
|
5,209 |
|
Total current assets |
228,035 |
|
|
106,474 |
|
Property, plant, and
equipment, net |
228 |
|
|
227 |
|
Operating lease right-of-use
asset |
3,629 |
|
|
264 |
|
Other assets |
78 |
|
|
47 |
|
Total assets |
$ |
231,970 |
|
|
$ |
107,012 |
|
LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
8,253 |
|
|
$ |
1,405 |
|
Accrued liabilities |
10,948 |
|
|
3,654 |
|
Operating lease liability |
80 |
|
|
178 |
|
Total current liabilities |
19,281 |
|
|
5,237 |
|
Operating lease liability,
noncurrent |
3,610 |
|
|
129 |
|
Other long-term
liabilities |
156 |
|
|
184 |
|
Total liabilities |
23,047 |
|
|
5,550 |
|
Convertible preferred stock |
— |
|
|
166,491 |
|
Stockholders’ equity
(deficit): |
|
|
|
Preferred stock |
|
— |
|
|
|
— |
|
Common stock |
3 |
|
|
— |
|
Additional paid-in capital |
338,617 |
|
|
1,244 |
|
Accumulated other comprehensive income (loss) |
— |
|
|
(1 |
) |
Accumulated deficit |
(129,697 |
) |
|
(66,272 |
) |
Total stockholders’ equity (deficit) |
208,923 |
|
|
(65,029 |
) |
Total liabilities, convertible
preferred stock and stockholders’ equity (deficit) |
$ |
231,970 |
|
|
$ |
107,012 |
|
|
|
|
|
|
|
|
|
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, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
30,009 |
|
|
$ |
7,214 |
|
|
$ |
55,191 |
|
|
$ |
13,417 |
|
General and administrative |
5,618 |
|
|
1,324 |
|
|
9,087 |
|
|
2,073 |
|
Total operating expenses |
35,627 |
|
|
8,538 |
|
|
64,278 |
|
|
15,490 |
|
Loss from operations |
(35,627 |
) |
|
(8,538 |
) |
|
(64,278 |
) |
|
(15,490 |
) |
Other income, net |
215 |
|
|
248 |
|
|
853 |
|
|
542 |
|
Net loss |
$ |
(35,412 |
) |
|
$ |
(8,290 |
) |
|
$ |
(63,425 |
) |
|
$ |
(14,948 |
) |
Per share information: |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(0.94 |
) |
|
$ |
(4.69 |
) |
|
$ |
(2.05 |
) |
|
$ |
(8.79 |
) |
Weighted-average shares used
in computing net loss per share, basic and diluted |
37,587,330 |
|
|
1,767,658 |
|
|
30,921,866 |
|
|
1,700,549 |
|
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