TRACON Pharmaceuticals, Inc.

For the three months ended March 31, 2024, research and development expense was $1.9 million versus $5 million a year ago, general and administrative expense was $1.4 million versus $2.3 million, and net loss was $3.2 million versus $8.5 million. Cash, cash equivalents and restricted cash were $8 million at March 31, 2024, down from $8.6 million at December 31, 2023. On the clinical side, TRACON reported that interim data in ENVASARC showed an 11% objective response rate by investigator review and 5.5% by blinded independent central review in 73 patients, with final data expected in the third quarter. Management reiterated that if 9 of 82 patients achieve confirmed responses by independent central review, the primary endpoint would be met, and said it plans to discuss a BLA filing strategy with the FDA if that occurs. The company also said the NCI-sponsored TRC102 study is designed to enroll 78 patients and detect an improvement in 1-year PFS from 56% to 75%, with final results expected in 2025.

Charles Theuer framed the quarter around two strategic priorities: advancing ENVASARC toward a potential filing and using the product development platform, or PDP, to generate nondilutive capital. He emphasized that ENVA could be positioned for refractory sarcoma first, then potentially expanded into frontline, adjuvant, and neoadjuvant settings through additional studies, if the pivotal data are positive. His tone was cautiously optimistic, but he also acknowledged the Nasdaq situation and said the company is working to solve it, with PDP monetization as the preferred path.

Scott Brown reported materially lower spending year over year, with R&D down to $1.9 million from $5 million and G&A down to $1.4 million from $2.3 million, contributing to a reduced net loss of $3.2 million versus $8.5 million. He also highlighted the balance sheet, with cash, cash equivalents and restricted cash of $8 million at March 31, 2024 versus $8.6 million at year-end 2023. The CFO did not provide a formal numeric cash runway, but the discussion implied continued reliance on PDP monetization and other financing options to support operations and satisfy listing requirements.

An analyst asked about PDP margins, and management gave a specific example from a prior I-Mab Phase I trial: TRACON received $9 million and spent just under $3 million, saying it can run oncology trials at roughly $100,000 per patient versus CRO bids of about $300,000 per patient. Management said a 30-patient trial could be priced to a partner at about $9 million, implying about a 200% profit margin for TRACON. The analyst also asked about Nasdaq compliance timing; Theuer said the preferred fix is PDP-generated capital or a license, and noted final ENVASARC data should be in Q3, after the June compliance date.