Plus Therapeutics(US:PSTV)2023-10-31 23:46Financial Data and Key Metrics Changes - As of September 30, 2023, cash and cash equivalents were $11 million, consistent with the balance at June 30, 2023 [16] - Net loss for Q3 2023 was $3.2 million or $1 per share, compared to a net loss of $5.2 million or $2.85 per share for the same period last year, indicating an improvement [18] - Total operating expenses for Q3 2023 decreased by $0.7 million to $4.5 million compared to $5.2 million for the same period last year, primarily due to the completion of CGMP drug development in 2022 [36] Business Line Data and Key Metrics Changes - The ReSPECT-GBM trial of Rhenium-186 Obisbemeda in recurrent glioblastoma (rGBM) is progressing, with a favorable safety profile and no dose-limiting toxicities reported across 34 patients [5][10] - In the Phase I trial, median overall survival for patients with absorbed doses greater than 100 gray was 70 weeks, compared to 22 weeks for those with doses less than 100 gray [25] - The ReSPECT-LM Phase I/IIa trial for leptomeningeal metastases (LM) is also advancing, with Cohort 4 being the fastest to enroll [27][29] Market Data and Key Metrics Changes - The company continues to receive interest in its CNS radiotherapeutic assets, attributed to a renewed interest in the radiotherapeutic space and the lack of approved treatments for LM and GBM [62] - The company has received a $3 million grant from the NIH to support the GBM trial through Phase II, expected to be fully utilized by the end of 2024 [35] Company Strategy and Development Direction - The company plans to complete enrollment in the Phase II ReSPECT-GBM trial and finalize pivotal trial design with the FDA [19] - The BAM radioembolic product will be regulated as a device, which is expected to reduce clinical requirements and approval timelines [33] - The company is focusing on expanding supply agreements and building supply chain redundancy, particularly regarding isotope availability [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing trials and the potential for accelerated approval for LM due to the lack of treatment options [48] - The FDA has requested additional information for both existing studies and the upcoming pediatric study, but management is confident in addressing these requests [64][65] - The company anticipates starting the Phase I ReSPECT pediatric brain cancer trial early next year, pending IND clearance from the FDA [53][57] Other Important Information - The company has successfully transferred proprietary materials and equipment from Biocept to utilize the CNSide assay for CSF tumor cell enumeration testing [13] - The company plans to implement the CNSide assay in the LM trial and is considering exercising an exclusivity option for the assay [51][52] Q&A Session Summary Question: What can be expected from the presentations at SNO? - The company will present updated imaging data and safety and efficacy data from the Phase II trial, with five abstracts accepted [41] Question: Will the speed of enrollment in Cohort 4 of the LM trial continue? - The company expects to maintain a similar enrollment rate and aims to complete the full dose escalation by June of next year [47] Question: What are the plans for implementing CNSide in the LM study after Biocept's bankruptcy? - The company has licensed the technology and will use it as a research tool in their trials, with plans to monitor the situation closely [71] Question: Will the additional funding cover the majority of Phase II study expenses? - Yes, the CPRIT funds will cover approximately two-thirds of all costs related to the study, making the grant very attractive [66] Question: Will the current cohort be the highest in the dose escalation study? - The company does not expect to reach a maximum tolerated dose but anticipates reaching a maximum feasible dose [67]