Concert Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to Concert Pharmaceutical Second Quarter 2022 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 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Justine Konigsberg, Senior Vice President, Corporate Communications and Investor Relations. You may begin.

Good morning and welcome to Concept Pharmaceuticals' second quarter 2022 investor update, which will include a discussion of our recently reported phase three results for CTP543 in alopecia areata. Details of the top line data are available in our corporate slide presentation, which can be found in the IR section of our website. 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 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 today's update. During the second quarter, we reported several key positive developments related to our CTP543 program in alopecia areata led by outstanding Phase III top-line data from the ThriveAA1 study. We're extremely pleased that our ThriveAA2 study released earlier this week produced similarly impressive top-line results, confirming and underscoring the rapid high level of efficacy observed with CTP543 in the treatment of moderate to severe alopecia areata. Our team is moving apace to further review and fully consolidate our clinical and non-clinical data, and we're advancing to filing a new drug application with the FDA, which is planned for the first half of 2023. Let me describe the market opportunity that we see before us. We envision that CTP543 will be well positioned to address an important unmet need for a large underserved population of patients with alopecia areata. Given the extent of patient need and the strong clinical profile we've seen to date with CTP543, we believe it has blockbuster potential. Based on current market assessments, there are multiple hundreds of thousands and potentially up to approximately 1.5 million patients in the U.S. with sizable subset having moderate to severe disease. with positive and consistent top-line results from both tri-A registration studies, we believe that CTP543 has demonstrated highly competitive product profile. We were one of the first companies to see the opportunity to develop groundbreaking treatments for alopecia areata. And now that we have our positive phase three data in hand, we're one step closer to providing what we hope will be the best-in-class treatment for patients. Both of the phase three Thrive AA clinical trials were randomized, placebo-controlled, double-blinded, multicenter studies evaluating the safety and efficacy of 543 in adults aged 18 to 65 years old who have 50% or greater scalp hair loss. Both trials were conducted in the US, Canada, and Europe. Each study included two doses of CTP543. 8 milligrams and 12 milligrams twice daily compared with placebo for 24 weeks. The primary endpoint for both trials is the percentage of patients achieving an absolute SALT score less than or equal to 20 at week 24 treatment, which we believe represents a clinically meaningful result. SALT, or the severity of alopecia tool, is 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 scalp. In the ThriveAA1 study, the primary endpoint met statistical significance in both the 8 milligram twice daily and 12 milligram twice daily dose groups compared to placebo. The treatment difference for both dose groups of CTP543 versus placebo at 24 weeks had a p-value of less than .0001. ThriveAA1 also met all the key secondary endpoints in both doses. These key secondary endpoints included statistically significantly higher levels of patient satisfaction with a scalp hair compared to placebo after 24 weeks of treatment and statistically significant hair regrowth as early as eight weeks. Similarly, we saw consistent results in Thrive AA2, our confirmatory phase three trial. As we announced earlier this week, The Thrive AA2 study met the primary endpoint for scalp hair regrowth and statistical significance in both the 8 and 12 milligram twice daily dose groups relative to placebo. The treatment difference for both dose groups of CTP543 versus placebo at 24 weeks had a p-value of less than .0001. Additionally, with regard to our key secondary endpoints, We again showed highly statistically significant patient satisfaction relative to placebo at both doses of CTP543. And we continued to see a rapid onset of effect with statistically significant differences from placebo in attaining SALT20 or better as early as 12 weeks into dosing. Treatment with CTP543 was generally well tolerated in both trials demonstrating a safety profile that we believe is well-suited for its proposed indication. Based on the results of Thrive AA1 and Thrive AA2, we continue to believe that CTP543 has the potential to be the best-in-class treatment for adults with moderate to severe alopecia areata. Many patients are impacted with alopecia areata in the prime of their lives, and for many people, the disease causes severe consequences, broadly and negatively impacting their ability to live their lives. With effective treatments just starting to become available, we hope that awareness for alopecia areata continues to grow and that it's truly recognized as a serious autoimmune disease and not misunderstood to be an inconsequential cosmetic condition. We're on the cusp of great change for the alopecia areata treatment community, And Concert is pleased and proud to be part of it. Let me pause here and turn the discussion to Mark, who will provide an overview of our financial results.