TRACON Pharmaceuticals (NASDAQ:TCON) Inc said it has ended its fiscal year 2021 with cash and equivalents of $24.1 million as of December 31, 2021, as the company outlined some key milestones for the coming year.
TRACON noted that it anticipates an interim ENVASARC safety and efficacy data review by the Independent Data Monitoring Committee (IDMC) in the second half of 2022.
The company also said it plans to initiate dosing of a Phase 1/2 clinical trial of envafolimab with YH001 in the second half of 2022.
“The ENVASARC trial remains our top priority in 2022, to address the significant unmet medical need in refractory sarcoma for the approval of safe and effective treatments,” TRACON Pharmaceuticals (NASDAQ:TCON) CEO Charles Theuer said in a statement.
READ: TRACON Pharmaceuticals says first patient dosed after approval for ENVASARC protocol received from FDA
“Based on prior clinical experience with envafolimab in more than 700 patients, we believe a doubling of the dose can be well-tolerated, result in higher exposures, and thereby potentially optimize efficacy for the greatest number of sarcoma patients,” Theuer added.
TRACON added that other expected key upcoming milestones for the yaer include: reporting the Arbitration Panel’s binding decisions with respect to the outcome of the legal disputes with I-Mab and; completing the TJ4309 trial this year, permitting I-Mab the opportunity to terminate the license for $9 million.
As well, the company saw its research and development expenses for the fourth quarter increase to $3.1 million, from $2.2 million during the same period last year, which it attributed to enrollment in the ENVASARC trial.
And, TRACON recorded 4Q general and administrative expenses of $4.6 million, compared to $2.0 million a year earlier, which the company said was related to legal expenses incurred due to the ongoing arbitration with I-Mab related to the TJ4309 and bispecific antibody agreements.
TRACON Pharmaceuticals (NASDAQ:TCON) 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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