SAN DIEGO - TRACON Pharmaceuticals (NASDAQ: OTC:TCON) announced today that the objective response rate (ORR) in its ENVASARC pivotal trial did not meet the primary endpoint, leading to the termination of the trial and a shift in the company's focus toward exploring strategic alternatives. The trial, which aimed for an ORR of 11%, only achieved a 5% response rate among the 82 evaluable patients.
As a result of the trial's outcome, TRACON is discontinuing further development of envafolimab and will cease all associated clinical development activities. The company plans to immediately reduce its cash burn to position itself more favorably for potential mergers, acquisitions, asset sales, or other strategic business combinations. TRACON's in-house Product Development Platform (PDP), which has conducted over 15 Phase 1, 2, or 3 oncology trials, will be leveraged in this process.
TRACON's CEO, Charles Theuer, M.D., Ph.D., expressed pride in the execution of the ENVASARC trial, which was the largest ever done for the sarcoma subtypes under study. Despite the trial not supporting a biologics license application (BLA) for envafolimab, the company is redirecting its efforts towards strategic alternatives.
The ENVASARC trial, which began dosing in December 2020, was conducted at 30 top cancer centers in the United States and the United Kingdom. It was designed as a multicenter, open-label, randomized, non-comparative, parallel cohort study with a primary endpoint of ORR by blinded independent central review.
The news comes as a notable development for TRACON, which utilizes a CRO-independent product development platform to advance the development of therapeutics in a cost-efficient manner. The company believes this platform can serve as a solution for companies without clinical capabilities who wish to become CRO-independent.
The information in this article is based on a press release statement from TRACON Pharmaceuticals.
InvestingPro Insights
In light of TRACON Pharmaceuticals' (NASDAQ: TCON) recent announcement regarding the ENVASARC trial, investors may be considering the financial health and future prospects of the company. According to the latest data from InvestingPro, TRACON has a market capitalization of $4.29 million USD. The company's revenue over the last twelve months as of Q1 2024 stood at $12.14 million USD, with a gross profit of $2.96 million USD, translating to a gross profit margin of 24.36%. Despite these figures, the company's operating income margin was negative at -23.03%, reflecting challenges in converting revenue into operating income.
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