– Phase 3 ELEVATE UC 12 trial reached full
enrollment; topline data expected Q1 2022 with ELEVATE UC 52
– Liquidity position at ~$1.0 billion as of
June 30, 2021 to support continued pipeline progress
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a
corporate update and reported financial results for the second
quarter ended June 30, 2021.
“With today’s announcement of the ELEVATE UC 12 trial reaching
full enrollment, we look forward to a potentially transformational
data readout of ELEVATE UC 12 and ELEVATE UC 52 in the first
quarter of next year. We are also pleased with our recently
announced partnership with Aristea to strengthen our mid-stage
immunology pipeline,” said Amit D. Munshi, President and CEO of
Arena. “We remain excited about moving forward to Phase 3 in atopic
dermatitis — a decision that is further supported by updated OLE
data. We are continuing to engage regulatory agencies worldwide in
the design of the program.”
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 for
the Phase 2/3 CULTIVATE trial sub-study A for etrasimod in Crohn’s
disease
- In August increased target enrollment in CULTIVATE sub-study A
from 50 participants to 70 participants; dose-ranging data to read
out in early Q2 2022; enhanced data may allow Sub-Study 1 to
transition to a registrational study and reduce the overall
timeline on the program
- In June the FDA granted Orphan Drug Designation status to
etrasimod for the treatment of eosinophilic esophagitis
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
- In April during a late-breaking session at The American Academy
of Dermatology Virtual Meeting, data from the Phase 2 ADVISE trial
in atopic dermatitis was presented that measured the impact of
etrasimod on patient and clinician reported outcomes
Cardiovascular
- In July a Phase 2 trial for temanogrel in Raynaud’s phenomenon
secondary to systemic sclerosis was initiated
- In July a Phase 2 trial for APD418 in acute heart failure was
initiated
- In June the first participant was dosed in the Phase 2 trial
for temanogrel in microvascular obstruction
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 Doug Manion was appointed as Executive Vice President,
Research & Development
- In June Steve Schoch was appointed to the Board of Directors
and as chair of the Audit Committee
- In May and June Arena earned score upgrades from ISS (Prime
rating) and MSCI (BB to A rating) following the 2021 Arena
Environmental, Social, Governance (ESG) Report published in
April
Financial Update
Second Quarter 2021 Financial Results
- Research and development (R&D) expenses for the second
quarter totaled $112.5 million compared to $64.9 million in the
same period 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 $8.7 million in the second quarter as compared to
$6.3 million in the same period 2020
- Selling, general and administrative (SG&A) expenses for the
second quarter totaled $31.9 million, compared to $22.9 million in
the second 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 $9.1 million in the
second quarter as compared to $6.0 million in the same period
2020
- Net loss for the second quarter was $146.1 million compared to
net loss of $84.9 million for the same period in 2020
- Basic and diluted net loss per share for the second quarter was
$2.40 compared to basic and diluted net loss per share of $1.61 for
the same period in 2020
- Cash, cash equivalents and marketable securities were $1.0
billion at June 30, 2021 as compared to $1.1 billion at December
31, 2020
Conference Call & Webcast Information
Arena will host a conference call and live webcast to discuss
the results with the investment community today, Thursday, August
5, 2021, at 4:30 PM ET, to discuss the financial results and
corporate update.
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
“expected,” “look forward to,” “on track for,” “plans,” and “will,”
and include, without limitation, statements about the following:
Arena’s clinical programs, including expectations regarding study
progress, the timing of data readouts for ongoing and anticipated
trials, expectations regarding the commencement of additional
studies, plans to provide updates on programs and 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: 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; clinical trials and other studies may
not proceed at the time or in the manner expected or at all; 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 March 31, 2021, which was filed with the SEC
on May 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 June
30,
Six Months Ended June
30,
2021
2020
2021
2020
Revenues:
Royalty revenue
$
—
$
—
$
—
$
262
Total revenues
—
—
—
262
Operating Costs and Expenses:
Research and development
112,453
64,946
214,988
143,479
Selling, general and administrative
31,938
22,877
61,396
49,319
Total operating costs and expenses
144,391
87,823
276,384
192,798
Loss from operations
(144,391
)
(87,823
)
(276,384
)
(192,536
)
Interest and Other Income
(Expense):
Interest income
328
3,065
1,018
8,011
Interest expense
(1,051
)
(1,144
)
(2,124
)
(2,307
)
Other (expense) income, net
(981
)
974
(891
)
1,697
Gain from Longboard equity method
investment
—
—
13,869
—
Total interest and other income (expense),
net
(1,704
)
2,895
11,872
7,401
Net loss
$
(146,095
)
$
(84,928
)
$
(264,512
)
$
(185,135
)
Net loss per share, basic and
diluted:
$
(2.40
)
$
(1.61
)
$
(4.39
)
$
(3.59
)
Shares used in calculating net loss per
share, basic and diluted:
60,786
52,771
60,286
51,500
Arena Pharmaceuticals,
Inc.
Condensed Consolidated Balance
Sheet Data
(In thousands, except share
data)
(Unaudited)
June 30, 2021
December 31,
2020
Assets
Current assets:
Cash and cash equivalents
$
514,177
$
219,544
Short-term investments,
available-for-sale
457,359
884,497
Prepaid expenses and other current
assets
18,899
35,266
Total current assets
990,435
1,139,307
Investments, available-for-sale
34,419
—
Land, property and equipment, net
20,388
22,090
Other non-current assets
39,417
29,323
Total assets
$
1,084,659
$
1,190,720
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable and other accrued
liabilities
$
23,417
$
35,351
Accrued clinical and preclinical study
fees
36,701
18,325
Current portion of lease financing
obligations
4,719
4,401
Total current liabilities
64,837
58,077
Other long-term liabilities
9,962
10,963
Lease financing obligations, less current
portion
38,780
41,211
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value,
7,500,000 shares authorized, no shares issued and outstanding at
June 30, 2021 and December 31, 2020
—
—
Common stock, $0.0001 par value,
147,000,000 shares authorized at June 30, 2021 and December 31,
2020; 61,044,996 and 58,611,210 shares issued and outstanding at
June 30, 2021 and December 31, 2020, respectively
6
6
Additional paid-in capital
2,743,225
2,587,494
Accumulated other comprehensive income
92
700
Accumulated deficit
(1,772,243)
(1,507,731)
Total stockholders' equity
971,080
1,080,469
Total liabilities and stockholders'
equity
$
1,084,659
$
1,190,720
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210805006093/en/
Corporate Contacts: 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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