TRACON(US:TCON)2021-05-06 16:10Financial Data and Key Metrics Changes - TRACON Pharmaceuticals reported a net loss of $5.1 million for Q1 2021, compared to a net loss of $4 million for the same period in 2020, indicating an increase in losses year-over-year [28] - Research and development expenses increased to $2.3 million in Q1 2021 from $2 million in Q1 2020, attributed to enrollment in the pivotal ENVASARC trial [27] - General and administrative expenses rose to $2.7 million in Q1 2021 from $1.9 million in Q1 2020 [27] - Cash, cash equivalents, and investments totaled $30.4 million as of March 31, 2021, down from $36.1 million at the end of 2020, with expectations to fund operations into the second half of 2022 [28] Business Line Data and Key Metrics Changes - The ENVASARC trial is a pivotal study for envafolimab, focusing on undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), with 22 sites initiated and over 20 patients enrolled [4][5] - The trial aims for a total of 25 sites by the end of Q1 2021, with multiple milestones expected throughout the year [5][6] - The company estimates that envafolimab could generate peak annual revenue of approximately $200 million in the U.S. if approved, with potential for additional revenue through label expansion into other refractory sarcoma subtypes [15][16] Market Data and Key Metrics Changes - The market assessment indicates that envafolimab could achieve a 15% response rate as a single agent and a 30% response rate when combined with Yervoy, significantly higher than the 4% response rate of the only approved therapy for refractory UPS and MFS patients [15] - The company is also exploring expansion into gastrointestinal stromal tumors (GIST) and other indications, with ongoing discussions for clinical trials [19][66] Company Strategy and Development Direction - The company continues to focus on advancing envafolimab through the ENVASARC trial, with plans to request breakthrough therapy designation or fast-track designation by year-end based on interim efficacy data [32] - There is a strategic interest in dual checkpoint inhibition, with plans to combine envafolimab with doxorubicin in first-line treatment trials [17][66] - The company is actively seeking additional clinical-stage assets to enhance its pipeline and leverage its CRO-independent product development platform [25][86] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing enrollment and safety reviews for the ENVASARC trial, noting robust accrual despite the COVID pandemic [33] - The company anticipates reporting final response data in 2022 and plans to submit a Biologics License Application (BLA) for accelerated approval if the data is positive [9][28] - Management highlighted the importance of addressing the high unmet clinical need in sarcoma and the potential for envafolimab to transform the standard of care [32] Other Important Information - The company has resubmitted its orphan drug application to the FDA, responding to requests for additional clinical evidence of envafolimab's activity in sarcoma [6][90] - The ongoing development of TRC102 and TJ4309, two other clinical-stage assets, is also a focus, with promising data reported in lung cancer and glioblastoma [20][23] Q&A Session Summary Question: Enrollment status in the ENVASARC trial - Management confirmed that enrollment is on track, with over 20 patients enrolled and a goal to fully enroll within 18 months [38] Question: DMC reviews and potential early updates - Management indicated that the DMC reviews will focus on safety, and any updates on efficacy will be communicated later in the year [42][44] Question: Activity of envafolimab in China - Management noted that envafolimab was well tolerated in patients with active hepatitis B in a trial, reaffirming its safety profile [58][60] Question: Expansion beyond sarcoma - Management discussed plans for trials in GIST and the potential for combining envafolimab with doxorubicin in frontline therapy [66][68] Question: Gating items for moving into first-line sarcoma - Management stated that evidence of activity from the ENVASARC trial will be critical for advancing into frontline trials [78] Question: Licensing opportunities for CTLA-4 inhibitors - Management expressed interest in licensing a CTLA-4 inhibitor to enhance their dual checkpoint inhibitor strategy [82][84]