Concert Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the Concert Pharmaceuticals Third Quarter 2021 Financial Results Conference 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. As a reminder, this 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. Please go ahead.

Good morning and welcome to Concert Pharmaceuticals Third Quarter 2021 Investor Update. Joining me this morning with prepared remarks are Roger Tung, our CEO, and Mark Becker, our CFO. Our prepared comments today will be brief, so we can jump right into the Q&A portion of the call, where we'll then be joined by Nancy Stewart, our Chief Operating Officer, and Jim Casella, our Chief Development Officer. 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 10-Q filed with the SEC. 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. 2021 has been all about the execution of our CTP543 pivotal program for alopecia areata. With each success milestone, our team continues to advance CTP543 to help bring this important new agent to commercialization. Along this path, we announced last month that the ThriveAA1 trial is fully enrolled. This was a large undertaking to enroll more than 700 patients in an international trial involving nearly 80 sites, all while dealing with a pandemic. I'm proud of the outstanding job that our team has been doing to manage this trial in line with our projected timelines. Looking past enrollment of our first pivotal trial, we remain on track to file our CTP543 NDA with the FDA in early 2023. We continue to expect top-line results from both the Phase III trials next year. The ThriveAA1 results are expected in the second quarter, and ThriveAA2 results are expected in the second half of 2022. Let me step back for some perspective on CTP543's potential in the therapeutic landscape. We're very excited about the data we've developed to date with 543. Unlike other autoimmune inflammatory diseases with currently approved therapies, Alopecia areata has to date proven poorly responsive to the mechanisms of action outside of JAK inhibition. Based on the results we've compiled so far with 543, as well as top line data releases for other compounds being developed in the field, we continue to believe that 543 has potential to be a best in class compound. During the past quarter, we had the opportunity to present findings from our ongoing 543 North American Open Label Extension Study at the second JAK Inhibitors Drug Development Summit. As this presentation summarized, over 100 patients have been dosed with 543 for at least a year and a half. Importantly, a high percentage of eligible patients have elected to continue to participate in the extension study. As we presented, treatment with CTP543 in the study continues to be generally well tolerated with adverse events consistent with those reported in the phase two studies. The findings showed that the SALT score assessing hair regrowth were maintained or improved in the vast majority of alopecia areata patients who continued in the study. To sum up, we remain steadfast and focused on our execution of the CTP543 clinical program On track for our pivotal data readouts next year, we believe we have competitively advantaged Jack and Eddie for treating alopecia areata. Above all, we hope to bring CTP543 to alopecia areata patients as soon as possible. Let me pause here and turn the call over to Mark.