TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q1 2020 Earnings Conference Call - Final Transcript
May 13, 2020 • 04:30 pm ET
Good day, ladies and gentlemen, and welcome to the TRACON Pharmaceuticals First Quarter 2020 Earnings Conference Call. [Operator Instructions]
During today's call, we will be making certain forward-looking statements, including statements regarding expected timing of clinical trials and results, regulatory activities, future expenses and cash runway, and our development plans and strategy. These statements are subject to various risks that are described in our filings made with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, and we disclaim any obligation to update such statements.
Now, I would like to turn the call over to Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. Dr. Theuer?
Good afternoon, and thank you for joining TRACON's first quarter 2020 financial results and business update conference call. I will begin with an update on our pipeline and recent activities. Following that, our Chief Accounting Officer, Scott Brown, will review our financial results for the three months ended March 31, 2020. Finally, we will conclude by taking your questions.
Our primary focus is on our recently in-licensed PD-L1 product candidate envafolimab, a late-stage potential best-in-class checkpoint inhibitor by virtue of its subcutaneous route of administration. We expect to begin enrollment in a pivotal study in sarcoma in the second half of this year. While envafolimab is our lead product candidate, we also anticipate significant milestones related to our three other clinical stage assets in the near-term.
Let's begin with a review of our recent meeting with the US FDA last week, where we reviewed and discussed our plans for the pivotal Phase 2 ENVASARC trial of envafolimab for the treatment of sarcoma. As a result of our May 8th Type B meeting with the US FDA, we expect to initiate the ENVASARC pivotal trial in the sarcoma's subtypes of undifferentiated pleomorphic sarcoma or UPS, and the closely related subtype of myxofibrosarcoma or MFS. This trial will include one cohort of approximately 80 patients, who will receive single agent envafolimab, and a second cohort of approximately 80 patients, who will receive envafolimab in combination with Yervoy, a second checkpoint inhibitor targeting the CTLA-4 receptor that is marketed by BMS.
The trial will enroll patients with UPS and MFS who have progressed on a single line of treatment and who have not received prior checkpoint inhibitor therapy. The primary endpoint in each of the cohorts will be objective response rate by RECIST by blinded independent central review, with duration of response being a key secondary endpoint. Each cohort will target a 15% response rate. And the trial is designed to detect a response rate that statistically excludes the known 4% response rate of Votrient, the only approved treatment for refractory sarcoma that includes UPS and MFS. Yes, you heard me correctly, and it is disappointing to report that the only approved treatment for refractory UPS and MFS has