On August 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 second quarter ended June 30, 2024, and provided an overview of recent and upcoming business highlights (Press release, Plus Therapeutics, AUG 14, 2024, View Source [SID1234645895]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Q2 2024 RECENT HIGHLIGHTS AND MILESTONES
•
Presented positive ReSPECT-LM Phase 1 study data at the 2024 Society for NeuroOncology /American Society for Clinical Oncology (SNO/ASCO) CNS Metastases Conference. Rhenium (186Re) Obisbemeda was safe and well-tolerated in the first 4 dosing cohorts (n=16 patients). Current median overall survival is 12 months with 8 of 16 patients treated remaining alive. Additional detail can be found here
•
Reported topline FORESEE clinical trial results at SNO/ASCO. The trial demonstrated that CNSide, PLUS’ novel diagnostic platform met its primary clinical endpoint. The CNSide test was found to help clinical decision making in over 90% of provider decisions (n=50/55 clinical decisions) and helped to inform therapy selection in 24% of provider decisions (n=13/55 clinical decisions). Furthermore, the CNSide test improved tumor cell detection in LM patients compared to cytology (80% vs. 29%) in matched samples. Additional details can be found here
•
Reported that isotopic rhenium-186, the active radioisotope in Rhenium (186Re) Obisbemeda, substantially spared the spinal cord vs. other beta-emitting radionuclides at the 2024 Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting
•
Submitted a new clinical protocol to the U.S. Food and Drug Administration (FDA), under its active Investigational New Drug application (IND 153715) for a Phase 1 study to evaluate multiple administrations of Rhenium (186Re) Obisbemeda for the treatment of patients with LM
•
Received $3.3 million grant payment from Cancer Prevention & Research Institute of Texas (CPRIT) in June 2024 to support the clinical development of Rhenium (186Re) Obisbemeda for LM
"Plus’ lead investigational drug Rhenium (186Re) Obisbemeda continues to show safety and promising signs of efficacy after a single administration in patients with LM," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We are on track to complete the single administration ReSPECT-LM Phase 1 trial soon, expand to multiple doses, and move to Phase 2 funded by our existing CPRIT award."
UPCOMING EVENTS AND MILESTONES
•
Presentations planned for the following upcoming medical conferences:
o
Congress of Neurological Surgeons (CNS) Annual Conference (September 28-October 2, 2024)
▪
Treatment Of Recurrent Glioblastoma (rGBM) Via Convection Enhanced Delivery (CED) With Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 2 Trial Update
o
Society for Neuro-Oncology (SNO) Annual Conference (November 22-26, 2024)
▪
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
▪
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
▪
The Oncogenetic 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
•
Complete ReSPECT-LM Phase 1 single administration trial and determine the recommended Phase 2 dose
•
Initiate ReSPECT-LM Phase 1 multiple administration trial
•
Obtain IND approval for a Phase 1/2 trial of Rhenium (186Re) Obisbemeda via convection enhanced delivery (CED) funded by the Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP) for pediatric ependymoma and high-grade glioma
FIRST HALF 2024 FINANCIAL RESULTS
•
The Company’s cash and investments balance was $8.4 million at June 30, 2024 compared to $8.6 million at December 31, 2023
•
The Company recognized $3.0 million in grant revenue in the first half of 2024 compared to $2.4 million in the same period of 2023, which represents CPRIT’s share of the costs incurred for our Rhenium (186Re) Obisbemeda development for the treatment of patients with LM
•
Total operating loss for the first half of 2024 was $7.0 million compared to $6.2 million in the same period of 2023. The increase is primarily due to increased spend related to the ReSPECT-LM trial
•
Net loss for first half of 2024 was $6.2 million, or $(1.15) per basic share, compared to a net loss of $6.3 million, or $(2.60) per basic share, for the same period the prior year
SECOND 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.
A live 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.