TRACON Pharmaceuticals, Inc. (NASDAQ:TCON) Q2 2020 Earnings Conference Call - Final Transcript
Aug 05, 2020 • 04:30 pm ET
Good day, ladies and gentlemen, and welcome to TRACON Pharmaceuticals' Second Quarter and 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?
Charles P. Theuer
Good afternoon, and thank you for joining TRACON's second quarter 2020 financial results and business update call. I will begin with an update on our pipeline and then recent activities. Following that, our Chief Accounting Officer, Scott Brown, will review our financial results for the three months and six months ended June 30, 2020.
Finally, we will conclude by taking your questions. We had a very productive quarter with our primary focus remaining on our recently in-licensed PD-L1 product, envafolimab, a late-stage potential best-in-class checkpoint inhibitor which may confer a clinical benefit by virtue of its unique rapid subcutaneous route of administration. As a reminder, TRACON has licensed North American rights to clinically develop and commercialize envafolimab in the indication of sarcoma.
As you will recall, TRACON met with the U.S. FDA on May 8 to review our plans for the pivotal ENVASARC trial of envafolimab for the treatment of sarcoma. Following that successful FDA meeting, on July 15, we filed the IND for the pivotal ENVASARC trial in the sarcoma subtypes of undifferentiated pleomorphic sarcoma, or UPS, and the closely related subtype of myxofibrosarcoma, or MFS, with the FDA. The 30-day FDA review period will end August 14. The pivotal trial will include two cohorts of 80 patients each. One cohort will receive single-agent envafolimab, and the second cohort 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 one or two lines of prior treatment that have not received prior checkpoint inhibitor therapy.
The primary endpoint in both cohorts will be objective response rate by RECIST as confirmed by blinded independent central review, with duration of response being a key secondary endpoint. Each cohort the demonstration of 9 out of 80 objective responses or an 11.25% objective response rate, confirmed by independent radiographic review, defines the level of response that satisfies the primary objective of the study, which is to statistically exclude the known 4% response rate of Votrient, the only approved treatment for refractory UPS and MFS.
Yes, you heard me correctly, unfortunately, the one approved treatment for refractory UPS