TRACON(US:TCON)2019-11-06 01:33Financial Data and Key Metrics Changes - TRACON reported no collaboration revenue for the three and nine months ended September 30, 2019, compared to zero and $3 million for the comparable periods of 2018 respectively, due to the absence of a corresponding revenue in 2019 [20] - Research and development expenses decreased to $3.1 million and $12.6 million for the three and nine months ended September 30, 2019, respectively, compared to $7 million and $24.5 million for the comparable periods of 2018, primarily due to lower manufacturing and clinical trial expenses [21] - General and administrative expenses were $2 million and $5 million for the three and nine months ended September 30, 2019, compared to $2.1 million and $5.5 million for the comparable periods of 2018 [21] - The net loss was $5.2 million and $18.7 million for the three and nine months ended September 30, 2019, compared to $9.1 million and $27.2 million for the comparable periods of 2018 [21] - Cash, cash equivalents, and short-term investments totaled $19.1 million at September 30, 2019, down from $26.3 million at June 30, 2019, and $39.1 million at December 31, 2018 [22] Business Line Data and Key Metrics Changes - The company is focused on four clinical stage assets: DE-122, TRC102, TRC253, and TJ004309, with significant clinical milestones expected in 2020 [24][25] - DE-122 is in a Phase II AVANTE study, with top line data expected in the first half of 2020 [7] - TRC102 is involved in multiple Phase I and II trials, with data presentations expected in 2020 [8] - TRC253 is in a Phase I/II trial, with proof-of-concept data expected in the first half of 2020 [10] - TJ004309 is in a Phase 1 dose escalation study, with top line data anticipated in the second half of 2020 [11] Market Data and Key Metrics Changes - The company is evaluating additional external clinical stage assets for potential addition to its pipeline in 2019 and 2020 [4] - TRACON aims to establish new corporate partnerships around first-in-class, best-in-class, or fast follower clinical stage assets [5] Company Strategy and Development Direction - The company continues to develop a robust pipeline of clinical stage assets and is tracking the progress of IMF's pipeline of multiple preclinical biospecific antibodies [4] - TRACON's strategy includes leveraging its CRO independent product development platform to establish key partnerships that drive long-term shareholder value [4] - The company plans to file an IND for the first bispecific antibody from its partnership with I-Mab in 2020 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategy to deliver on development and business plans for the benefit of patients and shareholders [26] - The expected clinical readouts in the first half of 2020 could result in success-based milestones, further extending the cash runway [26] Other Important Information - TRACON entered into an agreement with Aspire Capital to purchase up to $15 million of common stock, which could extend the cash runway into Q2 2021 [5] - The company retains significant financial rights to DE-122, including $145 million in remaining developmental, regulatory, and commercialization success-based milestones [7] Q&A Session Summary Question: Has the DE-122 study been reviewed by DSMB? - Yes, there is no DSMB interim look into that study, and final data is expected in the first half of next year [29] Question: Are you seeing a higher prevalence of the androgen receptor mutation for TRC253? - Yes, there is a second undisclosed point mutation with a higher prevalence than F877L, and data will be reported in the first half of next year [30] Question: How does the decision process work for selecting antibodies in the I-Mab pipeline? - The selection process involves evaluating bispecifics as they move through the IND enabling process, with TRACON entitled to nominate up to five assets over the next five years [34][35] Question: What has intrigued you about the 4-1BB program? - Engaging T-cells to turn cold tumors hot is seen as a promising therapeutic approach, making T-cell engagers more attractive than dual immune checkpoint targets [38] Question: What is driving the lower expected initial response rate for TRC253? - The lower response rate may be due to the heterogeneous nature of tumors with the F877L mutation, which may have other mechanisms of resistance [42]