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Monday, August 13, 2018 10:05:14 AM
- Initiated ADVANCE Phase 3 Program for Ralinepag in Pulmonary Arterial Hypertension (PAH)
- Completed Enrollment for Olorinab Study for Pain Associated with Crohn's Disease; Data in Q3:18
- Submitted Etrasimod Meeting Request to the FDA for Ulcerative Colitis (UC)
SAN DIEGO, Aug. 6, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today provided a corporate update and reported financial results for the second quarter ended June 30, 2018.
"We have made significant progress over the past three months across our clinical programs, including the initiation of our ADVANCE Phase 3 program for ralinepag in patients with PAH. We are excited for the opportunity to potentially advance the treatment paradigm for patients suffering from this critical illness," said Amit D. Munshi, President and CEO of Arena. "Additionally, we are pleased to have submitted our meeting request to the FDA for etrasimod in UC, and look forward to the data readout from our Phase 2 study of olorinab for pain associated with Crohn's disease in September."
Pipeline Update
Etrasimod – Next generation, oral, selective sphingosine-1-phosphate (S1P) receptor modulator intended for the potential treatment of multiple immune and inflammatory diseases
Ulcerative colitis (UC):
Crohn's disease (CD):
Primary biliary cholangitis (PBC):
Ralinepag – Next generation, oral, once-daily, selective prostacyclin receptor agonist intended for the potential treatment of pulmonary arterial hypertension (PAH)
Initiating three Phase 3 trials for the most comprehensive PAH clinical program
Open-label extension interim trial results expected in H2:18
Olorinab – Peripherally restricted, oral, full agonist of the cannabinoid 2 (CB2) receptor intended for the potential treatment of visceral pain, specifically pain associated with Crohn's disease
Completed enrollment in Phase 2 study in June, data expected in late September
Collaboration Update
In July 2018, Everest Medicines Ltd. submitted Investigational New Drug applications to the China Food and Drug Administration to initiate Phase 1 studies for etrasimod and ralinepag
In July 2018, Eisai Inc. reported positive topline results from CAMELLIA-TIMI61, a cardiovascular outcome trial for the anti-obesity agent BELVIQ®
In April 2018, Arena announced a licensing agreement with Outpost Medicine on a preclinical compound for the treatment of genitourinary disorders
Corporate Update
On October 4, 2018, Arena expects to host an Analyst and Investor Day in New York City
In July 2018, Arena appointed Kieran T. Gallahue as a non-executive director
Financial Update
Second Quarter 2018 Financial Results
Revenues totaled $4.0 million, consisting of $3.1 million in collaboration revenue, and $0.9 million in royalty revenue
Research and development expenses totaled $26.8 million
General and administrative expenses totaled $10.4 million
Net loss attributable to stockholders of Arena was $31.8 million, or $0.65 per share
At June 30, 2018, Arena's cash, cash equivalents and investments balance was $592.4 million and approximately 49.3 million shares of Arena common stock were outstanding.
Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today, Monday, August 6, 2018, at 4:30 p.m. EDT to discuss the financial results and provide a corporate update.
When: Monday, August 6, 2018, at 4:30 p.m. EDT
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 5986018
Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena's website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena's website for 30 days shortly after the call.
About Arena Pharmaceuticals
Arena Pharmaceuticals is focused on delivering novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena's proprietary pipeline includes multiple potentially first- or best-in-class programs with broad clinical utility. The most advanced investigational clinical programs are ralinepag (APD811), in a Phase 3 program for pulmonary arterial hypertension (PAH), and etrasimod (APD334), expected to commence a Phase 3 program for ulcerative colitis (UC) and a program in Crohn's Disease (CD), and which has potential utility for a broad range of immune and inflammatory conditions. Arena is also evaluating olorinab (APD371) in a Phase 2 study for the treatment of visceral pain associated with Crohn's disease, as well as other drug candidates in earlier research and development stages.
In addition, Arena has several collaborations including Everest Medicines Limited (ralinepag and etrasimod in Greater China and select Asian countries), Axovant Sciences GmbH (nelotanserin - Phase 2), Boehringer Ingelheim International GmbH (undisclosed target - preclinical), Outpost Medicine, LLC (undisclosed target – preclinical), and Eisai Co., Ltd. and Eisai Inc. (BELVIQ® - marketed product).
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 "look forward to," "intended," "potential," "planning," "expect," "expected," "expects," "will," and "focused on," and include, without limitation, statements about the following: design, initiation, enrollment, results, data readouts and timing relating to ongoing and intended clinical trials, such as statements about the timing of data from the open-label extension study of ralinepag, data from the Phase 2 trial of olorinab, and initiation and enrollment of the planned Phase 3 trials of ralinepag; the potential of Arena's drug candidates; Arena's upcoming Analyst and Investor Day; Arena's investment community conference call and webcast; and Arena's focus, goals, strategy, clinical programs, and collaborators. 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: we may need additional funds to advance all of our programs, and you and others may not agree with the manner we allocate our resources; risks related to developing and commercializing drugs; enrolling patients in our ongoing and intended clinical trials is competitive and challenging; 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 our drug candidates may not advance in development or be approved for marketing; risks and uncertainties relating to cash and revenues that may be generated from product sales or other sources, including the impact of competition; Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; risks related to unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and 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; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; topline data may not accurately reflect the complete results of a particular study or trial; satisfactory resolution of litigation or other disagreements with others; government and third-party payor actions, including relating to reimbursement and pricing; risks related to relying on collaborative arrangements; the entry into or modification or termination of collaborative arrangements; and 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 our Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the SEC on March 14, 2018, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which was filed with the SEC on May 9, 2018. 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.
Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer
klind@arenapharm.com
858.210.3636
Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384
(Tables Follow)
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three months ended
Six months ended
June 30,
June 30,
2018
2017
2018
2017
(unaudited)
(unaudited)
Revenues
Collaboration and other revenue
$ 3,133
$ 1,898
$ 4,161
$ 3,558
Royalty revenue
861
—
1,588
—
Total revenues
3,994
1,898
5,749
3,558
Operating Costs & Expenses
Research & development
26,755
17,700
48,328
33,044
General & administrative
10,405
7,150
21,556
14,670
Total operating costs & expenses
37,160
24,850
69,884
47,714
Total interest & other income (expense), net
1,333
(811)
1,169
(2,158)
Loss from continuing operations
(31,833)
(23,763)
(62,966)
(46,314)
Income (loss) from discontinued operations
—
147
(830)
201
Net loss
(31,833)
(23,616)
(63,796)
(46,113)
Less net loss attributable to noncontrolling interest in consolidated variable interest entity
—
299
—
743
Net loss attributable to stockholders of Arena
$ (31,833)
$ (23,317)
$ (63,796)
$ (45,370)
Amounts attributable to stockholders of Arena:
Loss from continuing operations
$ (31,833)
$ (23,464)
$ (62,966)
$ (45,571)
Income (loss) from discontinued operations
—
147
(830)
201
$ (31,833)
$ (23,317)
$ (63,796)
$ (45,370)
Net income (loss) attributable to stockholders of Arena per share, basic and diluted:
Continuing operations
$ (0.65)
$ (0.77)
$ (1.41)
$ (1.66)
Discontinued operations
—
—
(0.02)
—
$ (0.65)
$ (0.77)
$ (1.43)
$ (1.66)
Shares used in calculating net loss attributable to stockholders of Arena per share, basic and diluted:
49,263
30,299
44,655
27,371
Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
(In thousands)
(unaudited)
June 30, 2018
December 31, 2017
1
Assets
Cash & cash equivalents
$ 501,217
$ 158,837
Accounts receivable
2,334
2,357
Insurance recovery receivable
—
12,025
Prepaid expenses & other current assets
6,539
2,681
Total available for sale investments
91,190
112,482
Land, property & equipment, net
28,756
30,131
Other non-current assets
7,524
3,622
Assets of disposal group held for sale
—
17,140
Total assets
$ 637,560
$ 339,275
Liabilities & Stockholders' Equity
Accounts payable & accrued liabilities
$ 16,523
$ 15,622
Accrued litigation settlement
—
24,000
Total deferred revenues
1,415
2,177
Total lease financing obligations & other long-term liabilities
60,784
62,737
Liabilities of disposal group held for sale
—
27,595
Total stockholders' equity
558,838
207,144
Total liabilities & stockholders' equity
$ 637,560
$ 339,275
1 The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.
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