TRACON Pharmaceuticals announced the positive results of a six-month independent data monitoring committee (IDMC) review for the ongoing ENVASARC Phase 2 pivotal trial. The IDMC reviewed interim safety and efficacy data from more than 80 patients equally randomized into cohort C of single agent envafolimab or cohort D of envafolimab given in combination with Yervoy. Enrollment of the separate trial of TRACON's CTLA-4 antibody YH001 with envafolimab and doxorubicin will continue, based on multiple responses seen in the Phase 1 portion of the trial to date using a higher dose of the CTLA-4 antibody.

Phase 1 is designed to determine the optimal dose of YH001 in combination with envafolimaband doxorubicin, and the Company expects to report trial data at the Connective Tissue Oncology Society (CTOS) annual meeting in November. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S., Food and Drug Administration for envAFolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy. Such statements include, but are not limited to, statements regarding TRACON's expectations for the timing and scope of its clinical trials as well as timely achievement of expected endpoints and goals, the availability and expected results of clinical data and the timing of future reviews of data by the Independent Data Monitoring Committee, continued timely accrual in the ENVASARC Phase 2 Phase 2 pivotal trial, the potential for envafolimab to become a treatment option and the expected cost and timing benefits to the ENVASARC phase 2 pivotal trial due to TRACON's termination of cohort D. Risks that could cause actual results to differ from those expressed in these forward-looking statements include: risks associated with clinical development and regulatory approval of pharmaceutical product candidates; risks relating to cost variability of clinical trials.