TCON TRACON Pharmaceuticals Inc

Item 8.01 Other Events.

On June 20, 2023, TRACON Pharmaceuticals, Inc. (the “Company”) announced the positive results of an ad hoc six-month independent data monitoring committee (“IDMC”) review for its 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. Patients in cohort C who had at least two on study CT scans continued to demonstrate a double-digit ORR assessed by investigator and blinded independent central review. Envafolimab was well tolerated without a single greater than grade 2 drug related adverse event. A mandated interim analysis in the third quarter of 2023 is planned to be conducted after the 46th patient treated with envafolimab has completed a minimum of 12 weeks of efficacy evaluations and includes a futility rule that is being exceeded to date based on the current data.

The combination of envafolimab with Yervoy did not demonstrate the Company’s desired synergy compared to single agent envafolimab and the Company will terminate enrollment in cohort D, which is expected to result in a reduction in trial costs and potential acceleration of the timeline to final ENVASARC data. Enrollment of the separate trial of the Company’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 that is designed to determine the optimal dose of YH001 in combination with envafolimab and doxorubicin. The Company expects to report YH001 trial data at the Connective Tissue Oncology Society annual meeting in November 2023.

Forward Looking Statement

Statements contained in this current report regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this current report regarding the timing and results of future data from, and analyses regarding, the Company’s clinical trials, the expected cost and timing benefits to the ENVASARC Phase 2 pivotal trial due to the Company’s termination of cohort D, and the timing and scope of enrollment in clinical trials. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, risks related to clinical development and regulatory approval of pharmaceutical products, including the variability of cost and timing of results, among other factors, could cause results to differ materially from those expressed or implied by such forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement in this press release, except as required by law.