Plus Therapeutics (NASDAQ:PSTV) on Thursday detailed a strategic shift toward "pivotal trial readiness," supported by a recently completed $15 million public offering designed to extend the company’s cash runway into 2027.
The Houston-based biotech, which specializes in targeted radiotherapeutics for central nervous system (CNS) cancers, identified 2026 as a transformational year for its lead candidate, REYOBIQ™ (rhenium Re186 obisbemeda).
The company expects to report critical dose-optimization data in the third quarter for its leptomeningeal metastases (LM) program.
This will be followed in the fourth quarter by Phase 2 data for recurrent glioblastoma (GBM), which management intends to use as the basis for an end-of-phase meeting with the FDA to align on pivotal trial design.
"Our two key goals in 2026 are CNSide commercial scale-up and REYOBIQ pivotal trial readiness," said Dr. Marc H. Hedrick, President and CEO, during a conference call on Jan. 22.
Parallel to its clinical efforts, Plus is aggressively expanding its diagnostic arm, CNSide®.
The company is targeting a reach of 150 million covered lives in the U.S. this year, a goal it hopes to achieve by securing new commercial payor agreements and obtaining Medicare and Medicaid coverage.