Plus Therapeutics(US:PSTV)2023-10-30 16:00Drug Development and Clinical Trials - Plus Therapeutics, Inc. is developing rhenium (186Re) obisbemeda, a targeted radiotherapeutic for CNS cancers, with the potential to deliver radiation doses up to 20 times greater than traditional external beam radiation therapy (EBRT) [113]. - The ongoing Phase 1/2a ReSPECT-GBM trial has shown the ability to deliver up to 740 Gy of absorbed radiation to tumor tissue without significant toxicities, compared to the typical maximum dose of 30-35 Gray in EBRT [116]. - The FDA has granted Orphan Drug and Fast Track designations to rhenium (186Re) obisbemeda for recurrent glioblastoma (GBM) and leptomeningeal metastases (LM) [116]. - The Phase 2b trial for rhenium (186Re) obisbemeda is expected to enroll up to 31 patients over approximately 24 months, focusing on small- to medium-sized tumors [118]. - The ReSPECT-GBM trial is designed to explore increased dosing and multiple doses, with overall survival as the primary endpoint for future registrational trials [117]. - The ReSPECT-LM Phase 1 clinical trial for rhenium (186Re) obisbemeda began screening patients in Q4 2021 after receiving FDA Fast Track designation [124]. - Interim results from the ReSPECT-LM trial showed a consistent decrease in CSF tumor cell count/ml and good tolerability among all patients [127]. - A single dose of rhenium (186Re) obisbemeda in Cohort 1 achieved absorbed doses of 18.7 to 29.0 Gy to the ventricles and cranial subarachnoid spaces [128]. Financial Performance - Grant revenue recognized was $1.2 million and $3.6 million for the three and nine months ended September 30, 2023, respectively [143]. - Research and development expenses for the three months ended September 30, 2023, were $2.493 million, a decrease of $0.5 million compared to the same period in 2022 [145]. - General and administrative expenses for the three months ended September 30, 2023, were $1.998 million, a decrease of approximately $0.2 million compared to the same period in 2022 [149]. - The company expects aggregate research and development expenditures to increase significantly during the remainder of 2023 due to increased costs for the ReSPECT-LM clinical trial [147]. - Cash and cash equivalents decreased to $11.0 million as of September 30, 2023, from $18.1 million as of December 31, 2022, a decline of 39.0% [155]. - Net cash used in operating activities for the nine months ended September 30, 2023 was $11.0 million, slightly higher than $10.7 million in the same period of 2022 [170]. - Total net cash provided by financing activities for the nine months ended September 30, 2023 was $3.97 million, down from $13.35 million in the same period of 2022 [166]. - The accumulated deficit as of September 30, 2023 was $476.7 million, indicating ongoing financial challenges [155]. - The company raised approximately $4.3 million from the issuance of 1,819,993 shares under the September 2022 Distribution Agreement from January 1, 2023 to September 30, 2023 [158]. Grants and Funding - The company has an active $3.0 million NIH/NCI grant to support the clinical development of rhenium (186Re) obisbemeda for recurrent GBM [109]. - The CPRIT Grant provides up to $17.6 million over three years for the development of rhenium (186Re) obisbemeda, with a matching fund requirement of $1 for every $2 awarded by CPRIT [126]. Strategic Collaborations and Innovations - Plus Therapeutics has established a GMP-validated R&D and manufacturing facility in San Antonio, Texas, to support the production of rhenium (186Re) obisbemeda for clinical trials [107]. - The collaboration with Medidata Solutions has resulted in a Synthetic Control Arm® platform to enhance the Phase 2 clinical trial of rhenium (186Re) obisbemeda [120]. - Plus Therapeutics aims to minimize radiation exposure to healthy tissues while maximizing locoregional delivery and efficacy through its innovative drug formulation approaches [104]. - The company is focused on treating rare and difficult-to-treat cancers with significant unmet medical needs, leveraging its advanced radiotherapeutic platform [106]. Future Plans - The company plans to submit a pediatric brain tumor IND for rhenium (186Re) obisbemeda in Q4 2023 or Q1 2024 [133]. - The company has an ongoing need to raise additional cash to fund future clinical development programs and operations [156]. Expenses and Income - Stock-based compensation expense for Q3 2023 was $148,000, a 14.7% increase from $129,000 in Q3 2022 [152]. - Interest income for Q3 2023 was $119,000, compared to $48,000 in Q3 2022, representing a 147.9% increase [153]. - Interest expense decreased to $87,000 in Q3 2023 from $173,000 in Q3 2022, a reduction of 49.7% [153]. - The company expects interest expense to decrease in 2023 compared to 2022 due to scheduled debt principal repayments [154].