On November 14, 2024 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the third quarter ended September 30, 2024, and provided an overview of recent and upcoming business highlights (Press release, Plus Therapeutics, NOV 14, 2024, View Source [SID1234648396]).
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Q3 2024 RECENT HIGHLIGHTS AND MILESTONES
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Completed enrollment in the Phase 1 ReSPECT-GBM trial
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Obtained agreement from FDA to begin enrollment in the ReSPECT-LM multi-administration trial for patients with LM (IND 153715). The trial is expected to begin enrollment in early 2025 at seven U.S. trial sites
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Presented positive ReSPECT-GBM Phase 1/2 Trial update data at the 2024 Congress of Neurological Surgeons Annual Conference, showing Rhenium (186Re) Obisbemeda continues to demonstrate promising feasibility, safety, response, and efficacy signals across 42 treated patients. Additional details can be found here
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Expanded the ReSPECT-GBM Phase 1/2 Trial to new sites and referral regions: North Shore University in New York and Ohio State University in the Upper Midwest
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Entered into a Research and Collaboration Agreement with Brainlab, a leading, innovative software-driven med-tech company to implement optimized case planning software for convection-enhanced delivery or CED of Rhenium (186Re) Obisbemeda for brain cancers
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Received a $0.9 million grant payment as part of the $3 million award by the Department of Defense (DoD) Peer Reviewed Cancer Research Program Advancing Cancer Care through Clinical Trials Award to support the clinical development of Rhenium (186Re) Obisbemeda for pediatric brain cancer
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Established a GMP manufacturing partnership with SpectronRx to meet late-stage clinical and commercial forecasts for Rhenium (186Re) Obisbemeda. Additional details can be found here
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Obtained CLIA registration for our Houston-based facility supporting the CNSide Cerebrospinal Fluid Tumor Cell Enumeration Assay Platform, with CLIA compliance certification anticipated in early 2025
"Securing agreement from the FDA to initiate a Phase 1 multiple dose administration trial is a key next step in our integrated development plan for Rhenium (186Re) Obisbemeda for patients with LM," said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. "We are on track to complete both Phase 1 LM trials and move to later stage trials in 2025."
UPCOMING EXPECTED EVENTS AND MILESTONES
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Presentations planned for the following upcoming medical conferences:
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Society for Neuro-Oncology (SNO) Annual Conference (November 21-24, 2024)
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Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection
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CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment helps in clinical management of breast cancer and Non-Small Cell Lung cancer patients having Leptomeningeal Disease
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The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor
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San Antonio Breast Cancer Symposium (December 10-13, 2024)
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Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Update on Phase 1 dose escalation
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Complete ReSPECT-LM Phase 1 single dose administration trial and determine the maximum tolerated and recommended Phase 2 doses by year-end
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Initiate ReSPECT-LM Phase 1 multiple dose administration trial in 2025
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Complete ReSPECT-GBM Phase 2 enrollment by 2025
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Obtain IND approval for a Phase 1/2 trial of Rhenium (186Re) Obisbemeda for pediatric ependymoma and high-grade glioma
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Launch the CNSide Cerebrospinal Fluid Tumor Cell Enumeration Assay Platform as a laboratory-developed test (LDT) in 2025
THIRD QUARTER 2024 FINANCIAL RESULTS
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The Company’s cash and investments balance was $4.8 million at September 30, 2024 compared to $8.6 million at December 31, 2023. In addition, the Company received a $0.9 million grant payment from the DoD in October 2024, and is on track to receive the next CPRIT grant advance of $3.9 million within 90 days following this release
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The Company recognized $4.4 million in grant revenue year to date through September 30, 2024, compared to $3.6 million for the same period in 2023, which in both periods represents the Cancer Prevention & Research Institute of Texas’ (CPRIT) share of the costs incurred for our Rhenium (186Re) Obisbemeda development for the treatment of patients with LM
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Total operating loss year to date through September 30, 2024, was $10.8 million compared to $9.5 million for the same period in 2023. The increase is primarily due to increased spend related to the ReSPECT-LM trial
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Net loss year to date through September 30, 2024, was $9.1 million, or $(1.46) per basic share, compared to a net loss of $9.5 million, or $(3.54) per basic share, for the same period the prior year
THIRD QUARTER 2024 RESULTS CONFERENCE CALL
The Company will hold a conference call and live audio webcast at 5:00 pm Eastern Time today to discuss its financial results and provide a general business update.
The live audio webcast will be available at ir.plustherapeutics.com/events.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.