Concert Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Concert Pharmaceuticals Fourth 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. If you require any further assistance, please press star 0. I would now like to turn the call over to your host, Justine Konigsberg. You may begin.

Good morning and welcome to Concert Pharmaceuticals' fourth 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 will 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 your 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-K 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, and thank you, everyone, for joining us for our fourth quarter update. 2022 is the year for CTP543. The finish line is in sight, and assuming success in our Phase III program in alopecia areata, we intend to move as rapidly as possible to file our NDA with the FDA in the first half of 2023. As we look back on this past year, Concert's team executed extremely well on the CTP543 clinical program. particularly in light of the challenging and changing COVID-19 landscape during the past couple of years. The team's focus and responsiveness in implementing an initial clinical plan and responding to shifting conditions has paid off. The achievement of our 2021 milestones positions us strongly for the year ahead. This will be a data-rich year for Concert, with the first 543 Phase 3 data readout expected next quarter. Let me outline the status of our CTP543 program and expected upcoming data readouts. We have fully enrolled both of our pivotal trials, ThriveAA1 and ThriveAA2. These trials collectively enrolled over 1,200 patients in the US, Canada, and Europe. This was no small feat, and we did it within the timelines and goals initially laid out before the onset of the COVID-19 pandemic. We expect to report top-line results this year from Thrive AA1 in the second quarter. The Thrive AA2 top-line results are expected to follow soon thereafter in the third quarter. All patients in the Thrive AA trials and other CTP543 efficacy studies are eligible to enroll in the open-label long-term extension studies, whereby they will receive active treatment We will also continue to collect long-term safety data to support RNDA. The North American Open Label Extension Study has been ongoing since April 2019, providing us with a wealth of additional data. According to a recent paper, there could be up to about 1.5 million alopecia areata patients in the US with a sizable subset having moderate to severe disease. Currently, there are no FDA-approved treatments However, 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's a blockbuster opportunity. Patients have waited a long time, and we hope to provide them with an important therapeutic option. All of these factors, from our strong execution of the clinical program to the market opportunity, give us momentum and confidence as we prepare to move our focus from late-stage development to commercializing CTP543. As I conclude my remarks, let me emphasize why we're excited about 543. First, CTP543 is a potential best-in-class compound for alopecia areata with multiple Phase II clinical trials supporting its efficacy and safety profile. Second, alopecia areata is a very large untapped market opportunity in the medical dermatology space for which, to date, JAK inhibition is the only mechanism that has demonstrated consistent clinically meaningful efficacy. We expect to be a key player in the alopecia areata market. Lastly, even beyond our currently issued patents, we believe we will have IP protection for CTP543 for many years out. Our team has consistently demonstrated its ability to execute. We intend to do the same in 2022, and as mentioned, it will be a data-rich year. We have sufficient cash to bring us past data readouts for both CTP543 Phase III clinical trials. With that, let me turn the call over to Mark, who will review our financial results.