The CEO’s comments came as the San Diego-based company reported its first-quarter 2020 financial results that saw the company end the three-month period with $14.1 million in cash.
TRACON said it anticipates receiving orphan drug designation from the US Food and Drug Administration (FDA) for envafolimab in soft tissue sarcoma in the second half of 2020.
READ: TRACON Pharmaceuticals announces successful Type B meeting with FDA for Pivotal Study of Envafolimab in sarcoma
“We are pleased the FDA agreed with our pivotal ENVASARC trial design and endpoints as we believe it can enable a fast to market strategy to provide envafolimab as expeditiously as possible to sarcoma patients in need of a new therapy,” said Charles Theuer, CEO of TRACON.
“We look forward to the presentation of envafolimab clinical data by our corporate partner, 3D Medicines, at ASCO, enrolling the first ENVASARC patient in the second half of this year, and potentially becoming a commercial-stage company in three years.”
The pharmaceutical company said it expects its current cash and cash equivalents to fund operations into the first quarter of 2021, and could extend into the third quarter of 2021 if it were to fully utilize the $14.2 million that remains available under the Aspire Capital agreement signed in October 2019.
The firm spent $2 million on research and development during the quarter ended March 31 compared to $5.2 million in the year-ago quarter. The decrease was primarily attributable to lower manufacturing expenses and clinical trial expenses due to the discontinuation of the Phase 3 TRC105 program and lower manufacturing expenses for TRC253, TRACON told shareholders.
Its net loss narrowed to $4 million, compared to $7.2 million in the year-ago quarter.
Envafolimab is currently dosing in Phase 1 trials in the US and Japan and is being studied in China in a Phase 2 registration trial as a single agent in MSI-H tumor patients, and in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer.
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