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.
With a target of over 1,250 tests annually, the company is also preparing to launch additional cerebrospinal fluid (CSF) tumor characterization tests to broaden its diagnostic portfolio.
Financially, the company’s $15 million upsized offering—priced at $0.38 per unit—has provided the necessary liquidity to bridge the gap through these upcoming data readouts.
While the offering resulted in initial stock price volatility, analysts from H.C. Wainwright noted that the restructuring effectively extends the company's operating window through 2027, mitigating near-term financing risks as the company approaches high-value clinical inflections.
The company also plans to begin enrollment in a Phase 1 trial for pediatric brain cancer (ReSPECT-PBC) and complete its commercial manufacturing scale-up for REYOBIQ before year-end.