TRACON Pharmaceuticals Inc (NASDAQ:TCON) has reported fourth-quarter and fiscal year-end financial results, finishing off 2020 with cash and equivalents of $36.1 million as of December 31, while revealing some key upcoming company milestones.
TRACON expects its current cash, equivalents, and short-term investments will fund operations into the second half of 2022, after completing financings of about $13.8 million with multiple new and existing healthcare-focused institutional investors in December.
“We ended 2020 on a high note by enrolling the first patient in the ENVASARC pivotal trial within one year of licensing envafolimab and raising additional capital at market price that further extends our cash runway into the second half of 2022,” CEO Charles Theuer said in a statement.
READ: TRACON says cancer drug envafolimab gets priority review from Chinese regulators, according to corporate partners
He added: “We are focused on enrolling the ENVASARC trial expeditiously and expect the availability of interim data later this year, final data in 2022, and assuming positive clinical data and regulatory approval, to potentially commercialize envafolimab in 2023, in order to address a high unmet need for patients with myxofibrosarcoma (MFS) or undifferentiated pleomorphic sarcoma (UPS).”
As of February 5, TRACON said it had initiated 16 clinical sites and enrolled multiple patients at multiple sites in the pivotal ENVASARC trial of single-agent envafolimab and envafolimab combined with Yervoy.
The company recorded a 4Q net loss of $4.3 million, compared to a loss of $4 million during the same period last year, following a slight increase in research and general and administrative expenses.
TRACON also outlined some expected key upcoming milestones for the company, including:
- Independent Data Monitoring Committee review of ENVASARC safety data in 1H 2021
- Submit envafolimab response data to the FDA for orphan drug designation in sarcoma in 1H 2021
- Data presentation on TJ004309 Phase 1 results in 1H 2021
- Interim ENVASARC efficacy and safety data in 2H 2021
- Data presentation on TRC102 Phase 2 results in 2H 2021
- Request FDA breakthrough therapy designation for envafolimab in 2H 2021
- Decision on envafolimab NDA in China for MSI-H/dMMR cancer
TRACON has positioned itself as a collaboration partner that leads the regulatory filings, clinical trials, as well as US commercialization of best-in-class drug candidates, as an alternative to expensive contract research organization (CRO) based development.
Contact Sean at [email protected]
Story by ProactiveInvestors
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