– Phase 3 ELEVATE UC 52 and 12 on course
for Q1 2022 topline data readout
– First participant randomized in the
Phase 2 trial for temanogrel in Raynaud’s phenomenon secondary to
systemic sclerosis
– Strong liquidity position to support
continued pipeline progress
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a
corporate update and reported financial results for the third
quarter ended September 30, 2021.
“During the quarter, the team continued to make significant
progress across all key programs, including reaching full
enrollment for the ELEVATE UC 12 program,” said Amit D. Munshi,
President and CEO of Arena. “ELEVATE UC 12 and ELEVATE UC 52 remain
on track and we continue to look forward to the data readout in the
first quarter of next year.”
Key Program & Corporate Updates
Gastroenterology
- In August the Phase 3 ELEVATE UC 12 trial for etrasimod in
ulcerative colitis reached full enrollment; topline data for both
ELEVATE UC 12 and ELEVATE UC 52 expected contemporaneously in Q1
2022
- In August announced collaboration with Second Genome to
identify microbiome biomarkers associated with clinical benefit in
the CULTIVATE program for Crohn’s disease
- In August increased target enrollment in CULTIVATE study A from
50 participants to 70 participants; dose-ranging data anticipated
to read out in early Q2 2022; enhanced data may allow transition to
a registrational program and reduction of the overall program
timeline
Dermatology
- In July we evaluated an updated OLE data set from the Phase 2
ADVISE trial for 2 mg etrasimod in atopic dermatitis that
demonstrated meaningful effects at week 16 of the OLE period on
validated Investigator Global Assessment (vIGA) at 47%, Eczema Area
and Severity Index (EASI-75) at 72%, and Peak Pruritis Numeric
Rating Scale (PP-NRS) at 61% with consistent safety profile out to
one year
- In July the Phase 2 trial for etrasimod in alopecia areata was
amended to add a 3 mg cohort and expand patient population
subtypes; topline data expected 2H 2022
Cardiovascular
- In November the first participant was randomized in the Phase 2
trial for temanogrel in Raynaud’s phenomenon secondary to systemic
sclerosis
- In July a Phase 2 trial for APD418 in acute heart failure was
initiated
Corporate Updates
- In July we entered into a strategic collaboration and option
agreement with Aristea for the development of RIST4721, an oral,
selective CXCR2 antagonist being developed for the treatment of
palmoplantar pustulosis (PPP) and other neutrophil-mediated
diseases
- In July Dr. Doug Manion was appointed as Executive Vice
President, Research & Development
Financial Update
Third Quarter 2021 Financial Results
- Research and development (R&D) expenses for the third
quarter totaled $94.2 million compared to $79.8 million in the same
period in 2020. This increase was primarily driven by our advancing
clinical studies, including the etrasimod Phase 3 program, as well
as an increase in personnel expenses to support our clinical
programs. The R&D non-cash, share-based compensation was $8.1
million in the third quarter as compared to $6.6 million in the
same period in 2020
- Selling, general and administrative (SG&A) expenses for the
third quarter totaled $30.3 million, compared to $19.0 million in
the third quarter of 2020. This increase was primarily driven by an
increase in personnel expenses and other professional fees. The
SG&A non-cash, share-based compensation was $9.2 million in the
third quarter as compared to $5.8 million in the same period in
2020
- Net loss for the third quarter was $196.3 million compared to
net loss of $97.4 million for the same period in 2020. This
includes $70 million of Acquired In-Process R&D expense
associated with our recently announced collaboration with Aristea
Therapeutics
- Basic and diluted net loss per share for the third quarter was
$3.21 compared to basic and diluted net loss per share of $1.69 for
the same period in 2020
- Cash, cash equivalents and marketable securities were $0.8
billion at September 30, 2021 as compared to $1.1 billion at
December 31, 2020. In addition to normal operating cash burn for
the quarter, we made a $70 million payment in connection with our
recently announced collaboration with Aristea Therapeutics
Conference Call & Webcast Information
Arena will host a conference call and live webcast to discuss
the financial results and corporate update via a question and
answer session with the investment community today, Thursday,
November 4, 2021, at 4:30 PM ET.
Conference call will be broadcast live in listen-only mode on
the company’s investor relations website at
https://invest.arenapharm.com/events-presentations. Shortly after
the event, a recording will be archived under the investor
relations section of Arena’s website for 30 days.
About Arena Pharmaceuticals
ARENA Pharmaceuticals is a team with a singular purpose –
deliver important medicines to patients.
In a rapidly changing global market, we work with a sense of
urgency every day to understand the needs of all our stakeholders,
identify bold, sometimes disruptive, ideas to get medicines to
patients, and relentlessly execute until it’s done.
ARENA - Care More. Act Differently.
Etrasimod, temanogrel, and APD418 are investigational compounds
that are not approved for any use in any country.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements may be identified by words such as “on
course,” “on track,” “look forward to,” “expected,” and
“anticipated” and include, without limitation, statements about the
following: Arena’s clinical programs, including expectations
regarding study progress, the timing of data readouts for ongoing
trials, and other statements under “Key Program & Corporate
Updates” above. For such statements, Arena claims the protection of
the Private Securities Litigation Reform Act of 1995. Actual events
or results may differ materially from Arena’s expectations. Factors
that could cause actual results to differ materially from the
forward-looking statements include, but are not limited to, the
following: clinical trials and other studies may not proceed at the
time or in the manner expected or at all; topline data may not
accurately reflect the complete results of a particular study or
trial; results of clinical trials and other studies are subject to
different interpretations and may not be predictive of future
results; the timing and outcome of research, development and
regulatory review is uncertain, and Arena’s drug candidates may not
advance in development or be approved for marketing; enrolling
patients in Arena’s ongoing and intended clinical trials is
competitive and challenging; the duration and severity of the
coronavirus disease (COVID-19) pandemic, including but not limited
to the impact on Arena’s clinical operations, the operations of
Arena’s suppliers, partners, collaborators, licensees, and capital
markets, which in each case remains uncertain; risks related to
developing and commercializing drugs; Arena will need additional
funds to advance all of its programs; the impact of competition;
risks related to unexpected or unfavorable new data; the risk that
regulatory agencies may interpret or weigh the importance of data
differently and reach different conclusions than Arena or others,
request additional information, have additional recommendations or
change their guidance or requirements before or after approval;
satisfactory resolution of litigation or other disagreements with
others; and risks related to the enforcement of Arena’s and third
parties’ intellectual property rights. Additional factors that
could cause actual results to differ materially from those stated
or implied by Arena’s forward-looking statements are disclosed in
Arena’s filings with the Securities and Exchange Commission (SEC),
including but not limited to Arena’s Quarterly Report on Form 10-Q
for the quarter ended June 30, 2021, which was filed with the SEC
on August 5, 2021. These forward-looking statements represent
Arena’s judgment as of the time of this release. Arena disclaims
any intent or obligation to update these forward-looking
statements, other than as may be required under applicable law.
Arena Pharmaceuticals,
Inc.
Condensed Consolidated
Statements of Operations
(In thousands, except per share
amounts)
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
Revenues:
Collaboration and other revenue
$
—
$
20
$
—
$
20
Royalty revenue
—
—
—
262
Total revenues
—
20
—
282
Operating Costs and Expenses:
Research and development
94,180
79,820
309,168
223,299
Acquired in-process research and
development
70,000
—
70,000
—
Selling, general and administrative
30,305
19,002
91,701
68,321
Total operating costs and expenses
194,485
98,822
470,869
291,620
Loss from operations
(194,485
)
(98,802
)
(470,869
)
(291,338
)
Interest and Other Income
(Expense):
Interest income
205
1,825
1,223
9,836
Interest expense
(1,031
)
(1,120
)
(3,155
)
(3,427
)
Other (expense) income, net
(1,001
)
659
(1,892
)
2,356
Gain from Longboard equity method
investment
—
—
13,869
—
Total interest and other income (expense),
net
(1,827
)
1,364
10,045
8,765
Net loss
$
(196,312
)
$
(97,438
)
$
(460,824
)
$
(282,573
)
Net loss per share, basic and
diluted:
$
(3.21
)
$
(1.69
)
$
(7.61
)
$
(5.27
)
Shares used in calculating net loss per
share, basic and diluted:
61,140
57,779
60,574
53,608
Arena Pharmaceuticals,
Inc.
Condensed Consolidated Balance
Sheet Data
(In thousands, except share
data)
(Unaudited)
September 30,
2021
December 31,
2020
Assets
Current assets:
Cash and cash equivalents
$
386,653
$
219,544
Short-term investments,
available-for-sale
385,014
884,497
Prepaid expenses and other current
assets
19,253
35,266
Total current assets
790,920
1,139,307
Investments, available-for-sale
52,953
—
Land, property and equipment, net
19,558
22,090
Other non-current assets
37,596
29,323
Total assets
$
901,027
$
1,190,720
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable and other accrued
liabilities
$
30,037
$
35,351
Accrued clinical and preclinical study
fees
18,434
18,325
Current portion of lease financing
obligations
4,884
4,401
Total current liabilities
53,355
58,077
Other long-term liabilities
9,466
10,963
Lease financing obligations, less current
portion
37,485
41,211
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value,
7,500,000 shares authorized, no shares issued and outstanding at
September 30, 2021 and December 31, 2020
—
—
Common stock, $0.0001 par value,
147,000,000 shares authorized at September 30, 2021 and December
31, 2020; 61,280,176 and 58,611,210 shares issued and outstanding
at September 30, 2021 and December 31, 2020, respectively
6
6
Additional paid-in capital
2,769,148
2,587,494
Accumulated other comprehensive income
122
700
Accumulated deficit
(1,968,555
)
(1,507,731
)
Total stockholders' equity
800,721
1,080,469
Total liabilities and stockholders'
equity
$
901,027
$
1,190,720
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211104006169/en/
Patrick Malloy Arena Pharmaceuticals, Inc. Vice President,
Investor Relations & Corporate Communications
pmalloy@arenapharm.com 847.987.4878
Sara Doran Arena Pharmaceuticals, Inc. Associate Director,
Investor Relations & Corporate Communications
sdoran@arenapharm.com
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