Plus Therapeutics(US:PSTV)2020-10-23 01:17Financial Data and Key Metrics Changes - As of September 30, 2020, cash and cash equivalents decreased to $7.6 million from $17.6 million as of December 31, 2019 [12] - The company reported no revenues in Q3 2020, down from $4.8 million in the same period last year, attributed to the closeout of BARDA contracts [12] - Net loss for Q3 2020 was $1.7 million, compared to a net income of $0.5 million in Q3 2019, primarily due to a $7 million loss from discontinued operations in 2019 [16] Business Line Data and Key Metrics Changes - Research and development expenses were $0.3 million in Q3 2020, down from $0.9 million in Q3 2019, with a total of $1.6 million for the nine months ended September 2020 compared to $3.6 million in the same period in 2019 [13] - Sales and marketing expenses remained approximately $0.1 million in Q3 2020, unchanged from the previous year [14] - General and administrative expenses were $1 million for Q3 2020, unchanged from the same period last year, while for the nine months ended September 30, 2020, G&A was $3.8 million compared to $3.3 million in 2019 [15] Market Data and Key Metrics Changes - The FDA granted Orphan designation and Fast Track designation for RNL for the treatment of patients with recurrent glioblastoma during Q3 2020 [8] Company Strategy and Development Direction - The company is focused on advancing the development of RNL, with plans to complete enrollment in the ReSPECT trial by year-end 2020 and to report updated dataset enrollment progress at the Society for Neuro-Oncology meeting in mid-November [18] - The company is exploring additional clinical development programs for RNL, including indications such as leptomeningeal carcinomatosis, peritoneal carcinomatosis, and recurrent head and neck cancer [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the enrollment pace for Cohort 6 of the ReSPECT trial, citing corporate resources and partnerships with institutions like NCI as factors contributing to accelerated progress [32] - The company is awaiting specifics on potential funding opportunities from the state Cancer Fund, which could support RNL's development for additional indications [33] Other Important Information - The company announced the formation of a Clinical Advisory Board to support the development of RNL, consisting of experts in neurosurgery and neuro-oncology [7] - The company is actively manufacturing the drug for ReSPECT and is working on proper manufacturing controls and capabilities for late-stage clinical trials [19] Q&A Session Summary Question: Will overall survival data be provided at the upcoming meeting? - Yes, overall survival data will be provided, but it will include patients who have been recently treated and still alive, making it a blend of data [22] Question: Are alternative trial approaches being considered for RNL's registration study? - Yes, the company is considering synthetic controls and other trial approaches in discussions with the FDA, given the lack of approved treatments in the recurrent setting for nearly a decade [24] Question: What is the timeline for Cohort 6 enrollment? - Enrollment for Cohort 6 is expected to be similar to previous cohorts, with an accelerating pace due to corporate resources and additional sites being onboarded [32] Question: Is there an update on funding from the state Cancer Fund? - The company is awaiting specifics on a potential RFP for funding, which could support RNL for recurrent glioblastoma and other indications [33] Question: Will the company produce all drugs in-house for future studies? - The company plans to manufacture the drug in-house but may outsource some work due to the unique nature of the drug and supply chain logistics [40]