On September 22, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that it has finalized and signed a grant contract with the Cancer Prevention & Research Institute of Texas (CPRIT) for its previously announced $17.6 million Product Development Research funding award (Press release, Cytori Therapeutics, SEP 22, 2022, View Source [SID1234621347]). The award will cover the majority of the development costs of the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), for the treatment of patients with leptomeningeal metastases (LM) over a three-year period, beginning in the fourth quarter of 2022.
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"This award from CPRIT significantly strengthens the company’s balance sheet," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "This non-dilutive funding coupled with existing cash, extends our expected cash runway through 2025. Currently, our two lead CNS cancer programs are externally funded through Phase 2 and multiple clinical milestones."
The agreement provides for $17.6 million in funding from CPRIT over the three-year grant period starting on August 31, 2022 and follows the expected increase of development costs as the ReSPECT-LM clinical trial progresses to later stages:
Year 1: September 1, 2022 to August 31, 2023: $3.7 million
Year 2: September 1, 2023 to August 31, 2024: $6.7 million
Year 3: September 1, 2024 to August 31, 2025: $7.2 million
The Company reported $18.1 million in cash as of June 30, 2022. In conjunction with the National Institutes of Health (NIH) and CPRIT grants, together with cash on hand, the Company believes it has capital to fund both its currently planned overhead and development expenses through 2025.
In the second quarter of 2022, the Company completed enrollment of Cohort 1 in the ReSPECT-LM Phase 1/2a dose escalation trial (NCT05034497). Blinded interim data for Cohort 1 was reviewed and assessed by the independent Data and Safety Monitoring Board (DSMB) which determined it was appropriate to begin enrolling patients in Cohort 2. The U.S. Food and Drug Administration has granted Fast Track designation to 186RNL for the treatment of LM. Safety and feasibility data from the ReSPECT-LM clinical trial was recently presented at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases.