TRACON Pharmaceuticals (NASDAQ:TCON) Inc said it has ended its third quarter 2021 with cash and equivalents of $29.9 million as of September 30, 2021, as the company expects to file an investigational new drug application (IND) and initiate a Phase 1/2 trial of YH001 combined with envafolimab in soft tissue sarcoma subtypes in early 2022.
TRACON also noted it anticipates initiating trials of YH001 in other indications in combination with approved standard of care agents in late 2022.
“The license of the potential best-in-class CTLA-4 antibody YH001 complements our prior license of the subcutaneously administered PD-L1 antibody envafolimab and satisfies our goal of owning complementary checkpoint inhibitors,” TRACON Pharmaceuticals (NASDAQ:TCON) CEO Charles Theuer said in a statement.
READ: TRACON Pharmaceuticals and China-based Eucure Biopharma strike partnership to develop clinical-stage CTLA-4 antibody YH001
“We expect to initiate a trial combining these two drug candidates in sarcoma in the coming months,” Theuer added.
As well, the company said ENVASARC continues to enroll well at 26 sites and it expects to release interim efficacy data before the end of the year.
TRACON also outlined other key company milestones, including the request of US Food and Drug Administration (FDA) breakthrough therapy designation or fast track designation for envafolimab by end of 2021, assuming positive interim efficacy data, as well as a decision on the envafolimab New Drug Application submitted by its partners 3D Medicines and Alphamab Oncology, in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration.
The company recorded a net loss of $7 million for the quarter, compare with a $4 million deficit during the same period last year, as general and administrative expenses increased primarily due to legal expenses incurred due to the ongoing arbitration with I-Mab related to the TJ4309 and bispecific antibody agreements.
TRACON Pharmaceuticals 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-based development.
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