Arena Pharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Arena Pharmaceuticals second quarter 2021 update. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero on your touchstone telephone. I would now like to turn the conference over to your host, Patrick Malloy, Vice President of Investor Relations. Thank you. Please go ahead.

Good afternoon, everyone, and thank you for joining us today. We hope you had a chance to review the press release we issued this afternoon announcing our Q2 2021 financial results and key program updates. Joining me on today's call are Amit Munshi, President and Chief Executive Officer, Lori Stelzer, our Executive Vice President and Chief Financial Officer, Doug Mannion, our Executive Vice President of Research and Development. And joining us for the Q&A session will be our Executive Vice President and Chief Commercial Officer, Rob Lesicki. Before we begin, I would like to remind you that we'll be making forward-looking statements that involve risks and uncertainties about our goals, expectations, plans, beliefs, timing of events or future results, including those risks and uncertainties related to our pipeline, financial projections, and the COVID-19 pandemic and its potential to impact business. Forward-looking statements involve certain assumptions, risks, and uncertainties, some of which may be beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in our earnings press release and our latest SEC disclosure document. All forward-looking statements are based on information currently available to ARENA, and we disclaim any obligation to update these forward-looking statements. Now, I would like to turn the call over to Amit Munshi. Amit?

Thanks, Pat, and thanks, everyone, for jumping on today's call. I presume everyone's had a chance to review the press release we issued this afternoon where we announced some very important updates. I'll provide some initial comments, and then Doug will take you through the program updates in more detail and the advised open-label data set, and then we'll hand out to Lori to walk through the Q2 financial performance. Following the prepared comments, we'll spend the remaining time on Q&A. Before we begin, I'd like to formally introduce our newly appointed Executive Vice President and Head of Research and Development, Dr. Doug Mannion. Doug comes to ARENA with 25 years of executive leadership experience across clinical research and drug development with companies such as DuPont Merck, GlaxoSmithKline, and Bristol-Myers Squibb. Most recently, he was CEO of Clio Pharmaceuticals. Doug's extensive experience, including experience in immunology and in our therapeutic areas, will be instrumental as we continue to transform into a sustainable global organization. Turning to slide three. If you've been following the ARENA story over the course of the past year, you'll know that in early 21, we laid out three strategic principles critical to our long-term growth. First, we plan to selectively and prudently grow our pipeline to support our long-term vision for the business. Second, we will continue to put all the pieces in place to ensure commercial launch success. And third, we continue to advance the build out of our leadership team that will maintain and grow our culture for success. As you can see, we're progressing forward on all three of these principles. Turning now to slide four. Last week, we took an important first step to bolster our mid-stage pipeline within our core therapeutic areas with the announcement of our collaboration and option agreement with Airstate of Therapeutics. We have a high bar for in-licensing and collaboration agreements, and over the course of the past year, we evaluated over 200 potential deals. Very few of these opportunities presented to us met our essential criteria. First, small molecules that were well characterized with chemistry and pharmacology, second, alignment within our current therapeutic area focuses of GI dermatology and cardiology, and three, limited financial exposure prior to program B risking. The deal with Aristea checks all three of these boxes. RISC-4721 is an oral small molecule GPCR CXCR2 antagonist that was originated by AstraZeneca with strong pedigree in chemistry and pharmacology. As you can see from the slide, RISC-4721 enhances our early to mid-stage clinical development pipeline with a Phase IIb-ready asset in pulmonary plantar postulosis, or PPP, and an opportunity to explore RISC-4721's potential in hydradenitis superlativa, or HS, and IBD through a couple of small exploratory trials. What is important to note is that this is a fiscally sound deal structure that includes a nominal upfront investment It grants us the option to acquire Aristea on the library of CXCR2 molecules based on the outcome of the Phase IIb PPP study and other supporting trials. Turning to slide five. In addition to pipeline progress we made through the Aristea acquisition, I'm happy to share some important program updates. As most of you are aware, we are studying a TRASMOD or selective S1P receptor modulator in two global Phase III studies of ulcerative colitis. As we announced in January of this year, we reached full enrollment in our 52-week study, Elevate 52, and that study remains on track for top-line data readout in Q1 of 22. Today, I'm extremely excited to announce that our TRASMOD Elevate 12, the UC12, has reached full enrollment ahead of expectations. And with that, I'll hand it off to Doug to provide additional details on the TRASMOD and the Elevate trial, as well as other programs.