TRACON Pharmaceuticals Announces Q1 2024 Financial Results and Corporate Update

TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical-stage biopharmaceutical company based in San Diego, made a significant announcement on May 14, 2024. The company shared its financial results for the first quarter ending March 31, 2024, and discussed other key corporate developments. A conference call and webcast were scheduled for the same day at 4:30 PM Eastern Time to elaborate on these updates.

Under the leadership of President and CEO Charles Theuer, M.D., Ph.D., TRACON is making noteworthy strides in the realm of targeted cancer therapeutics. With the ENVASARC trial fully enrolled, the company is now concentrating on using its Product Development Platform to generate non-dilutive capital. This could be achieved either through additional licensing agreements or by assuming the responsibilities typically handled by Contract Research Organizations (CROs), thus conducting clinical trials for partners at a lower cost but still at a premium compared to their internal expenditures. The company anticipates sharing the final response assessment data for all patients involved in the ENVASARC Phase 2 pivotal trial in the third quarter of 2024.

In April, TRACON released updated interim results from the ENVASARC Phase 2 pivotal trial, which involved 73 patients receiving envafolimab as a single agent. The data showed an objective response rate (ORR) of 11% according to investigator review and 5.5% by blinded independent central review (BICR), with all responses being confirmed. The median duration of response by BICR exceeded six months, and the treatment was generally well tolerated.

The company's financial status and recent decisions were also highlighted. In April, TRACON received an extension from the Nasdaq Hearings Panel to meet all criteria for continued listing on The Nasdaq Capital Market by June 3, 2024. This included a reverse stock split and the filing of an S-1, both of which were completed in April. The company is exploring other options to fulfill the $2.5 million stockholders’ equity requirement by the given deadline.

TRACON reported having $8.0 million in cash, cash equivalents, and restricted cash as of March 31, 2024, down from $8.6 million at the end of 2023. This funding is expected to support the company's operations into the third quarter of 2024. Research and development expenses saw a significant decrease, dropping to $1.9 million in the first quarter of 2024 from $5.0 million in the same period of 2023. This reduction is mainly attributed to the completion of patient enrollment in the ENVASARC Phase 2 trial. General and administrative expenses were also reduced to $1.4 million from $2.3 million in the first quarter of the previous year. Consequently, the net loss for the first quarter of 2024 was $3.2 million, a notable improvement from the $8.5 million loss in the first quarter of 2023.

Envafolimab, a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is a significant part of TRACON's clinical pipeline. It is the first approved subcutaneously injected PD-(L)1 inhibitor, having received approval from the Chinese NMPA in November 2021 for adult patients with MSI-H/dMMR advanced solid tumors who have no satisfactory alternative treatment options. TRACON holds the rights to develop and commercialize envafolimab in soft tissue sarcoma in North America and is currently conducting the pivotal ENVASARC Phase 2 trial in the United States. Additionally, envafolimab is undergoing a Phase 3 trial in China for advanced biliary tract cancer in collaboration with Alphamab Oncology and 3D Medicines. The U.S. FDA has granted orphan drug designation and fast track designation to envafolimab for specific sarcoma subtypes.

TRACON continues to advance its clinical-stage pipeline and seeks additional corporate partnerships to enhance its product development platform. The company remains committed to addressing unmet medical needs through innovative cancer therapeutics and aims to become a preferred partner for firms lacking clinical and commercial capabilities in the U.S. or those looking to become CRO-independent.