TRACON Pharmaceuticals (NASDAQ:TCON) Tuesday announced that it has ended its third quarter 2020 with cash and cash equivalents of $26.5 million at September 30, 2020, up from $16.4 million at the end of 2019.
The company says it expects its current funding to sustain operations into the first quarter of 2022, following approximately $10 million in private placement equity financings and pre-funded warrants at market from multiple healthcare focused institutional investors in August 2020.
TRACON Pharmaceuticals CEO Charles Theuer said in a statement: “We made great progress during the quarter by securing capital from dedicated healthcare funds that extends our runway past expected ENVASARC registration trial interim data and into 2022. We expect to enroll patients at multiple sites in the ENVASARC trial this year and also expect our partners to submit envafolimab for approval in China before the end of the year.”
He added: “We are focused on enrolling the ENVASARC trial expeditiously so we may deliver interim data in 2021, final data in 2022, and assuming positive clinical data and regulatory approval, potentially commercialize envafolimab in 2023 and thereby address a high unmet need within sarcoma.”
Key expected milestones for TRACON going forward include:
- enrolling patients at multiple sites into the ENVASARC registration trial during the fourth quarter of 2020;
- the submission of envafolimab for approval in MSI-H/dMMR CRC to the National Medicinal Products Administration (NMPA) in China by its corporate partners 3D Medicines and Alphamab Oncology;
- Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021;
- an FDA decision on orphan drug designation for envafolimab in sarcoma in 1H 2021 and;
- interim ENVASARC efficacy and safety data in mid-2021
TRACON is developing targeted therapies for cancer utilizing a CRO independent, product development platform. The company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC253, a Phase 3 ready small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors.
Contact Sean at firstname.lastname@example.org