Concert Pharmaceuticals, Inc.

good day and thank you for standing by and welcome to the concert pharmaceutical second quarter 2021 financial result conference call at this time our participants are on a listen-only mode after the speaker's presentation there will be a question and answer session please be advised that today's conference is being recorded 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 hand the conference over to your speaker today, Justine Coonsburg. Please go ahead.

Good morning and welcome to Concert Pharmaceutical second quarter 2021 investor update. Like last quarter, our prepared comments today will be brief, so we can jump right into the Q&A portion of the call. Roger Tung, our CEO, will provide the CTP 543 key highlights, and then Mark Becker, our CFO, will walk you through the second quarter financials. We will then be joined by Nancy Stewart, our Chief Operating Officer, and Jim Casella, our Chief Development Officer, for the Q&A portion of the call. 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 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. This past quarter, we continued to execute on the pivotal clinical development of CTP543 for alopecia areata. We presented additional promising data from our long-term open-label study of CTP543, and we strengthened our balance sheet. Importantly, we remain on track to file our CTP543 NDA in the early part of 2023. In the second quarter, we initiated Thrive AA2 our second Phase III trial for CTP543. As a reminder, this study has a similar design to the ThriveAA1 trial. Between the two ThriveAA studies, we expect to enroll more than 1,000 individuals with moderate to severe alopecia areata. These Phase III trials are long-term extension studies and other ongoing and completed trials will provide us with a sizable safety database, including a significant number of patients receiving treatment for longer than one year to support our NDA. We continue to engage with treatment community about CTP543 and to be a vocal advocate for the needed progress in the treatment of alopecia areata. For example, last month we had the opportunity to present findings from the ongoing CTP543 open label extension study at the second JAK inhibitors drug development sub-end. Currently, over 100 patients have been dosed with CTP543 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. Treatment with CTP543 in the study continues to be generally well tolerated with adverse events consistent with those reported in the phase two studies. Importantly, SALT scores assessing hair regrowth were maintained or improved in the vast majority of alopecia areata patients who continued in the study. CTP543 has the potential to be a best-in-class treatment for alopecia areata and remains the top priority for our business. Our team is focused on expeditiously executing the Phase III Thrive AA clinical program and is deep into planning for the regulatory pathway to NDA. There's an enormous need for an FDA-approved treatment for alopecia areata, and we're proud that Concert was one of the first in the industry to take notice of this important disease by advancing CTP543. Let me pause here and turn the call over to Mark.