Concert Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the Concert Pharmaceuticals First Quarter 2022 Investor Update Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to Justine Konigsberg, Senior Vice President, Corporate Communications and Investor Relations. Please go ahead.

Good morning and welcome to Concert Pharmaceuticals' first quarter 2022 investor update. Our prepared comments today will be brief, so we can jump right into the Q&A portion of the call. Joining me this morning with prepared remarks are Roger Tung, President and CEO, and Mark Becker, Chief Financial Officer. Nancy Stewart, Chief Operating Officer, and Jim Casella, Chief Development Officer, will join the team for Q&A. As a reminder, today's discussion will include forward-looking statements about our future expectations, plans, and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10Q filed with the FCC. Any forward-looking statements speak only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call. With that, I would now like to turn the call over to Roger.

Thank you, Justine, and thank you, everyone, for joining us for today's update. With top-line results from our pivotal clinical trials coming during this and the next quarter, We remain focused on bringing CTP543 to the finish line and assuming Phase 3 success, we're well positioned to file our NDA in the first half of 2023. Both of our Phase 3 Thrive AA clinical trials are randomized, placebo-controlled, double-blinded, multicenter studies evaluating the safety and efficacy of CTP543 in adults age 18 to 65 years old who have 50% or greater scalp hair loss. Each study is evaluating two doses of CTP543, 8 milligrams and 12 milligrams, twice daily, compared with placebo for 24 weeks. The primary endpoint is the percentage of patients achieving an absolute SALT score of less than or equal to 20, which is believed to represent a clinically meaningful result. Our top line data announcement from ThriveAA1 will include its primary endpoint and key safety data. We'll look to present more detailed findings from the study at future medical meetings. Recall that in our Phase II dose-ranging study, both the 8 mg and 12 mg twice-daily doses achieved a significantly greater proportion of patients with a SALT score of less than or equal to 20 relative to placebo. For those not familiar with SALT, or the severity of alopecia tool, it's a measure to determine the amount of scalp hair coverage by assessing four regions of the scalp that contribute to the total score, which ranges from 0 to 100. A SALT score of 0 corresponds to no scalp hair loss, while a SALT score of 100 corresponds to a total lack of hair on the scalp. As we shared in the past, there could be up to approximately a million and a half alopecia areata patients in the U.S. with a sizable subset having moderate to severe disease. Currently, there are no FDA-approved treatments. Even with other potential players in the market, given the extent of patient need and the clinical profile we've seen to date with CTP543, we believe it has blockbuster potential in the treatment of alopecia areata. We're hopeful that phase three results will confirm our phase two and long-term open-label extension observations, and that CTP543 will be an effective and durable treatment for alopecia areata. with a generally well-tolerated safety profile consistent with its intended use. Among the JAK inhibitors being developed for the treatment of alopecia areata, our Phase II results of CTP543 appear to have a highly competitive profile, and we're working to bring it to patients as quickly as possible. I'd like to pause here and turn the discussion to Mark, who will provide an overview of our financial results.