Plus Therapeutics (NASDAQ:PSTV), during its Third Quarter 2023 Results Conference Call, announced progress in its clinical and regulatory programs, financial health, and future milestones. The company is advancing in its ReSPECT-GBM trial for recurrent glioblastoma (rGBM) and expects to complete Phase II enrollment by the end of 2024. The company reported a net loss of $3.2 million for Q3 2023, with cash and cash equivalents standing at $11 million as of September 30, 2023. It expects to receive $10.2 million in non-dilutive cash grant funding from CPRIT by December 31, 2024, along with additional grants from the NIH.
Key takeaways from the call include:
- The company's ReSPECT-GBM trial of Rhenium-186 Obisbemeda for rGBM is progressing well, with positive safety data and no dose-limiting toxicities. Efficacy data will be presented at the Society for Neuro-Oncology (SNO) meeting in November.
- The ReSPECT-LM Phase I/IIa trial for leptomeningeal metastases (LM) is also advancing, with rapid enrollment in Cohort 4 and favorable safety profiles.
- Plus Therapeutics has acquired the proprietary materials and equipment for the CNSide assay used in the LM trial, following Biocept (OTC:BIOCQ)'s insolvency.
- The company is planning to initiate a pediatric brain cancer trial and develop its Rhenium-188 nanoliposome biodegradable alginate microsphere (BAM).
- The company anticipates receiving a $3.3 million advance from CPRIT before reporting its full-year 2023 results, with additional advances in 2024 totaling $10.2 million.
- The company also expects additional grants from the NIH and forecasts grant revenue of $1 million to $1.5 million in Q4 2023 and $6 million to $7 million for calendar year 2024.
- Total operating expenses for Q3 2023 decreased by $0.7 million compared to the same period the prior year.
Looking forward, Plus Therapeutics plans to complete enrollment in the Phase II GBM and Phase I LM trials, initiate the Phase II LM trial, and seek FDA IND approval for the Phase I pediatric brain cancer trial. The company is also working towards key development milestones for the 188RNL-BAM device. The company's balance sheet, based on current cash on hand and committed grant funding, provides a runway into 2025.
The company also confirmed that they will continue utilizing the CNSide platform in their LM study, despite Biocept's bankruptcy. They have acquired the necessary protocols and testing kits and may exercise their option for exclusivity in the future. The company concluded the call by expressing gratitude for the questions and interest and stated they will provide further updates soon.
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