TRACON(US:TCON)2019-03-01 01:54Financial Data and Key Metrics Changes - TRACON reported no collaboration revenue for Q4 2018 and $3 million for the year ended December 31, 2018, compared to zero and $8.8 million for the comparable periods of 2017 [41] - Research and development expenses increased to $5.9 million for Q4 2018 and $30.5 million for the year, compared to $4.6 million and $19.4 million for the same periods in 2017 [43] - The net loss was $7.8 million for Q4 2018 and $35 million for the year, compared to $6.6 million and $19.1 million for the same periods in 2017 [45] - Cash, cash equivalents, and short-term investments totaled $39.1 million at December 31, 2018, compared to $34.5 million at December 31, 2017 [46] Business Line Data and Key Metrics Changes - TRC105 is currently in a Phase 3 TAPPAS trial enrolling angiosarcoma patients, with 120 patients enrolled to trigger preparations for interim analysis [5][6] - The Phase 2 trial of TRC105 in combination with Nexavar in liver cancer showed a confirmed partial response rate of 24% [8] - The Phase 2 TRAXAR trial of TRC105 and Inlyta in kidney cancer did not meet its primary endpoint [9][10] - DE-122, an ophthalmic formulation of TRC105, is in a Phase 2 AVANTE study with data expected in the first half of 2020 [18][19] Market Data and Key Metrics Changes - TRACON reacquired rights to develop TRC105 in Greater China from Ambrx, with plans to engage a new corporate partner for development [15][16] - The company is actively seeking partners for TRC105 in Europe and Japan [16][81] Company Strategy and Development Direction - TRACON aims to identify ex-U.S. companies with first-in-class or best-in-class clinical-stage assets to utilize its product development platform [38][49] - The company is focusing on partnerships, as evidenced by the collaboration with I-Mab Biopharma for the development of CD73 antibody TJ4309 [33][34] Management's Comments on Operating Environment and Future Outlook - Management expects a number of potentially value-creating milestones over the next twelve months, including interim analysis from the TAPPAS trial and top-line results from the AVANTE trial [48] - The company anticipates lower annual research and development expenses in 2019 compared to 2018 due to decreased manufacturing expenses for TRC105 [45][94] Other Important Information - TRACON retained significant financial rights with DE-122, including $145 million in potential developmental, regulatory, and commercialization milestones [21] - The company is working on biomarker validation for TRC102 to identify patients most likely to respond to treatments [27][100] Q&A Session Summary Question: Insights on TAPPAS trial patient demographics and safety signals - Management has not yet analyzed the database for definitive answers but will provide clarity after the interim analysis [53][54] Question: Breakdown of patients from U.S. versus ex-U.S. in TAPPAS trial - The majority of patients are from the U.S., with a roughly equal proportion of cutaneous and non-cutaneous patients expected [56] Question: Update on TRC253 trial presentation - Management aims to present Phase 1 data at a significant meeting, such as ASCO, in June [58] Question: Durability of stable disease in patients from the combo study - Management confirmed that the PR patient remains on study with significant tumor mass reduction, but specific percentage reductions were not provided [59] Question: Potential enrichment strategies for CD73 program - Enrichment strategies will focus on CD73 expression analysis and other relevant biomarkers [63][64] Question: Capacity for bringing new assets into clinical development - The platform is generalizable to various products marketed to physician-specialty audiences, with a focus on oncology [70] Question: R&D spending outlook for 2019 - R&D expenses are expected to decrease in 2019 compared to 2018, aligning closer to 2017 levels [94]