On May 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or 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 first quarter ended March 31, 2025, and provides an overview of recent and upcoming business highlights (Press release, Cytori Therapeutics, MAY 30, 2025, View Source [SID1234653516]).
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"We improved our cash position in the first quarter as a result of both a financing and grant support," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "With the additional cash and further anticipated grant support in 2025, we are well positioned to make solid progress in our 2 key business goals: enrollment in our REYOBIQ CNS cancer radiotherapeutic clinical trials and the planned launch of the CNSide cerebral spinal fluid (CSF) assay platform."
Q1 2025 & RECENT HIGHLIGHTS AND MILESTONES
Corporate
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Raised gross proceeds of $15 million in a private placement financing – along with a $2.0 million grant award advance from the Company’s existing grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to accelerate development of REYOBIQ for our leptomeningeal metastases (LM) program.
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Added industry veteran Kyle Guse to the Board of Directors – Mr. Guse brings 30 years of professional experience in multiple executive roles, including as a Chief Financial Officer and a General Counsel of innovative companies.
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Strengthened management team with addition of Dr. Michael Rosol as Chief Development Officer – Dr. Rosol will lead the Company’s clinical, pre-clinical, and biomarker development activities.
REYOBIQ Clinical Trials
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Presented updated interim data on its lead compound REYOBIQ at the Nuclear Medicine and Neuro-oncology conference held May 9-10, 2025 in Vienna, Austria that highlighted the safety and clinical benefit of REYOBIQ in patients with LM.
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Published Phase 1 clinical trial results for REYOBIQ in peer-reviewed publication Nature Communications, demonstrating safety and potential efficacy in treating recurrent glioblastoma (GBM), with patients receiving a radiation dose >100 Gy achieving a median overall survival of 17 months, more than double the standard of care. Additional details can be found here.
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Completed ReSPECT-LM Phase 1 single dose administration trial and determined the maximum tolerated and recommended Phase 2 dose. Additional details can be found here.
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Granted U.S. FDA Orphan Drug Designation for REYOBIQ for the treatment of LM in patients with lung cancer.
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Received U.S. FDA conditional agreement for the proprietary name REYOBIQ for the Company’s lead radiotherapeutic, rhenium Re186 obisbemeda.
CNSide CSF Assay Platform
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Strengthened management team with key leadership appointments:
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Russell Bradley as President and General Manager of Plus Therapeutics’ wholly owned subsidiary, CNSide Diagnostics, LLC ("CNSide Diagnostics") – Mr. Bradley provides leadership to CNSide Diagnostics with an immediate focus on commercialization of the CSF assay platform.
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Dr. Jonathan Stein as Medical Director, CNSide Diagnostics – Dr. Stein provides technical leadership to support the CNSide CSF assay platform.
Q1 2025 FINANCIAL RESULTS
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The Company’s cash balance was $9.9 million at March 31, 2025 compared to $0.1 million at December 31, 2024.
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The Company recognized $1.1 million in grant revenue in the first quarter of 2025 compared to $1.7 million in in the first quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM.
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Total operating loss for the first quarter of 2025 was $3.5 million compared to $3.3 million in the same period of 2024. The increase is primarily due to increased legal fees.
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Net loss for first quarter of 2025 was $17.4 million, or $(1.19) per share, compared to a net loss of $3.3 million, or $(0.75) per share, for the same period the prior year.