PLUS THERAPEUTICS (PSTV) Company Report

Plus Therapeutics secured a $15 million oversubscribed offering, which, combined with ongoing grants, extends its financial runway through 2027.
The company provided updates on its RIOVA clinical program, including FDA feedback for ReSPECT-LM to accelerate development, with data anticipated in Q3 2026 for dose optimization and Q4 2026 for recurrent GBM Phase II enrollment completion, aiming for pivotal trial readiness by early 2027.
For CNSIDE U.S. commercialization, Plus Therapeutics has achieved state licensure in 49 of 50 U.S. states and secured agreements with UnitedHealthcare and Humana, covering 67 million U.S. lives. The goal is to reach over 150 million covered lives and for the CNSIDE business to be break-even by 2027.
Key 2026 commercialization milestones for CNSIDE include ramping testing utilization to at least 1,250 tests per year and establishing a base of 50 or more unique ordering physicians.

Jan 22, 2026, 2:00 PM

Transcript

Plus Therapeutics Provides Corporate Update on CNSide Relaunch and REYOBIQ Clinical Progress

PSTV

Product Launch

New Projects/Investments

Guidance Update

Plus Therapeutics (PSTV) is undertaking a U.S. commercial relaunch of its CNSide diagnostic platform in Q3 2025, targeting a >$6 billion total addressable market. The company has already secured national coverage agreements with UnitedHealthcare and Humana, covering 51 million and 16 million lives, respectively.
The company's lead radiotherapeutic, REYOBIQ, is advancing through multiple mid-stage ReSPECT clinical trials for CNS cancers, including leptomeningeal metastases (LM) and recurrent glioblastoma (rGBM), with the rGBM Phase 2 trial completing in 2025. REYOBIQ has received FDA Fast Track & Orphan Designations and targets a >$16 billion total addressable market.
Key 2026 milestones include expanding CNSide's covered lives to >150 million, obtaining Medicare and Medicaid coverage, and establishing a customer base of 50 or more unique ordering physicians. For REYOBIQ, milestones include completing enrollment in the ReSPECT-GBM Phase 2 trial, defining the optimal dose for the ReSPECT-LM Phase 2 expansion trial, and enrolling the first patient in the ReSPECT-PBC pediatric brain cancer Phase 1 trial.

Jan 22, 2026, 2:00 PM

Presentation

Plus Therapeutics Provides Business Update, Outlines 2026 Goals and Financial Runway

PSTV

Guidance Update

New Projects/Investments

Plus Therapeutics recently completed a $15 million offering that extends its cash runway through 2027, allowing for expanded investments in its CNSIDE business and completion of two ongoing Phase II RIOVA clinical trials.
The company targets its CNSIDE business to be break-even by 2027.
For the RIOVA clinical program, data from the ReSPECT-LM trial is anticipated in Q3 2026, and recurrent glioblastoma Phase II trial data is expected in Q4 2026.
CNSIDE commercialization goals for 2026 include reaching over 150 million covered lives and increasing testing utilization to at least 1,250 tests per year, with approximately 5,000 tests annually required for CNSIDE profitability.

Jan 22, 2026, 2:00 PM

Transcript

Plus Therapeutics Provides Business Update, Announces Funding and Clinical Progress

PSTV

Guidance Update

New Projects/Investments

Product Launch

Plus Therapeutics announced a $15 million offering on January 14, 2026, which, combined with ongoing grants, extends the company's financial runway through 2027.
The company received positive FDA feedback in November 2025 for its ReSPECT-LM clinical program, leading to a randomized pivotal clinical trial design and aiming for pivotal trial readiness by early 2027. Data from the ReSPECT-LM trial is anticipated in Q3 2026, and recurrent glioblastoma trial data in Q4 2026.
For CNSIDE commercialization, Plus Therapeutics has secured 67 million U.S. lives covered through agreements with UnitedHealthcare and Humana, with a 2026 goal to reach over 150 million covered lives and ramp testing utilization to at least 1,250 tests per year. The CNSIDE business is targeted to be break-even by 2027, requiring approximately 5,000 tests for profitability.

Jan 22, 2026, 2:00 PM

Transcript

Plus Therapeutics provides 2026 business update

PSTV

New Projects/Investments

Guidance Update

Plus Therapeutics' primary goals for 2026 are CNSide commercial scale-up and REYOBIQ pivotal trial readiness.
A recently completed $15 million offering is expected to extend the company's cash runway through 2027.
For the REYOBIQ clinical program in 2026, the company anticipates reporting data from the ReSPECT-LM Phase 2 trial in Q3 2026 and from the ReSPECT-GBM Phase 2 trial in Q4 2026, alongside completing commercial manufacturing scale-up and initiating the ReSPECT-PBC pediatric brain cancer Phase 1 trial.
Regarding CNSide commercialization in 2026, Plus Therapeutics aims to achieve coverage for 150 million US lives under commercial payor agreements, secure Medicare and Medicaid coverage, and reach a commercial order rate exceeding 1,250 tests per year.

Jan 22, 2026, 12:45 PM

Press Release

PLUS THERAPEUTICS, INC. Details Commercial Relaunch of CNSide Diagnostic and Clinical Trial Progress for REYOBIQ

PSTV

Product Launch

New Projects/Investments

Guidance Update

PLUS THERAPEUTICS, INC. (PSTV) commercially relaunched its CNSide® diagnostic in Q3 2025, targeting a total addressable market exceeding $6 billion and projecting 500,000 patients per year.
The company secured initial national coverage agreements for CNSide with UnitedHealthcare and Humana, nearing 100 million covered lives, and aims to expand coverage to over 150 million lives in 2026.
PSTV is progressing its REYOBIQ radiotherapeutic with the completion of the recurrent glioblastoma (rGBM) Phase 2 trial in 2025 and plans to enroll the first patient in the pediatric brain cancer (PBC) Phase 1 trial in 1Q 2026.
The FDA indicated that accelerated approval may be appropriate for the ReSPECT-LM indication, with alignment on a randomized controlled design.

Jan 22, 2026, 12:30 PM

8-K

Plus Therapeutics Announces FDA Feedback on REYOBIQ Pivotal Trial Strategy

PSTV

New Projects/Investments

Product Launch

Plus Therapeutics (PSTV) completed a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss the pivotal trial strategy for REYOBIQ in treating leptomeningeal metastases (LM).
The FDA indicated that accelerated approval may be appropriate for the LM indication, recommending that the study evaluate an endpoint with established clinical benefit, such as overall survival, and discussed a randomized controlled trial design.
Plus Therapeutics plans to incorporate the FDA's feedback into its current dose optimization trial, seek alignment on a revised protocol later this year, and accelerate REYOBIQ commercial manufacturing and scale-up activities to meet an expedited timeline.

Jan 8, 2026, 12:30 PM

Press Release

Plus Therapeutics Receives Nasdaq Minimum Bid Price Extension

PSTV

Delisting/Listing Issues

Plus Therapeutics, Inc. (PSTV) has received an additional 180-day extension from the Nasdaq Listing Qualifications Department to regain compliance with the $1.00 minimum bid price requirement.
The company now has until May 11, 2026, to meet this requirement.
To regain compliance, the closing bid price of the common stock must be at least $1.00 per share for a minimum of 10 consecutive business days.
This extension does not immediately affect the company's continued listing status on the Nasdaq Capital Market.
There is no assurance that the company will be able to regain compliance.

Nov 17, 2025, 12:30 PM

Press Release

Plus Therapeutics Reports Q3 2025 Financial Results and Business Highlights

PSTV

Earnings

Product Launch

New Projects/Investments

Plus Therapeutics reported a net loss of $4.4 million, or $0.04 per share, for the third quarter ended September 30, 2025, with a cash and investments balance of $16.6 million as of that date.
The company introduced its CNSide CSF diagnostics platform to the U.S. market, securing a national coverage agreement with UnitedHealthcare effective September 15, 2025, which covers over 51 million people.
Positive Phase 1 clinical trial results for its targeted radiotherapeutic, REYOBIQ, were presented, demonstrating feasibility, a favorable safety profile, and promising efficacy in treating leptomeningeal metastases.
Plus Therapeutics also received an additional $1.9 million advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT) and regained compliance with Nasdaq listing criteria.