Arena Pharmaceuticals, Inc. provided a corporate update and reported financial results for the second quarter ended June 30, 2019.
“Arena is off to a strong 2019 and we remain highly focused on achieving several key clinical and regulatory goals. We are excited to have recently initiated two important trials, the etrasimod Phase 3 ELEVATE UC 52 trial and the olorinab Phase 2 CAPTIVATE trial. We will provide further detail around the CAPTIVATE trial on today’s call,” said Amit D. Munshi, President and CEO of Arena. “Execution is key for Arena this year, following several positive data readouts and strategic transactions across our pipeline. We look forward to demonstrating the potential benefits and differentiation of our first- or best-in-class assets as we continue to deliver these exciting milestones.”
Pipeline Update
Etrasimod – Next generation, once-daily, oral, selective sphingosine-1-phosphate (S1P) receptor modulator in development for the treatment of multiple immune and inflammatory diseases
- Ulcerative colitis (UC): The global Phase 3 ELEVATE UC registrational program will consist of two key trials to evaluate etrasimod 2 mg in subjects with moderately to severely active UC
ELEVATE UC 52, a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance; trial was initiated in June
ELEVATE UC 12, a 12-week trial, which is expected to initiate at a later date to optimize speed to market - Crohn’s disease (CD):
CULTIVATE Phase 2b/3 program planning ongoing - Atopic dermatitis (AD):
ADVISE Phase 2b trial planning ongoing
Olorinab – Oral, peripherally acting, highly selective, full agonist of cannabinoid type 2 receptor (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases
- Abdominal pain associated with irritable bowel syndrome (IBS):
- CAPTIVATE is a Phase 2b trial to evaluate three dose levels of olorinab for 12-weeks in approximately 240 subjects experiencing abdominal pain associated with IBS, including IBS with constipation (IBS-C) and IBS with diarrhea (IBS-D). The primary endpoint will measure the improvement from baseline in the weekly Average Abdominal Pain Scale (AAPS); trial was initiated in July
Etrasimod and olorinab are investigational compounds that are not approved for any use in any country.
Financial Update
Second Quarter 2019 Financial Results
- Revenues totaled $1.0 million, primarily consisting of $0.9 million of royalty revenue
- Research and development expenses totaled $51.2 million, including $7.0 million related to non-cash share-based compensation
- General and administrative expenses totaled $18.4 million, including $6.4 million related to non-cash share-based compensation
- Net loss was $61.4 million or $1.24 per share
At June 30, 2019, Arena’s cash, cash equivalents and investments balance was over $1.2 billion and approximately 49.8 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, Wednesday, August 7, 2019, at 4:30 PM EDT to discuss the financial results and provide a corporate update.
lease 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 driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first- or best-in-class assets with broad clinical utility. Etrasimod (APD334), with potential utility in a broad range of immune and inflammatory conditions, is being evaluated in late-stage clinical programs in ulcerative colitis (UC) and Crohn’s disease (CD), as well as in programs for other indications such as atopic dermatitis. Arena is also evaluating olorinab (APD371) in a Phase 2 program for gastrointestinal pain. Arena continues to assess other earlier research and development stage drug candidates, including APD418 for decompensated heart failure.
