Plus Therapeutics, Inc. (PSTV): History, Ownership, Mission, How It Works & Makes Money

Plus Therapeutics, Inc. (PSTV): History, Ownership, Mission, How It Works & Makes Money

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Plus Therapeutics, Inc. (PSTV) is a name you're hearing more often in the biotech space, but what's driving its current market valuation of approximately $0.07 billion as of November 2025? This clinical-stage pharmaceutical company is tackling some of oncology's toughest challenges, like leptomeningeal metastases, by using targeted radiotherapeutics-a specialized approach that delivers radiation directly to the tumor via its lead candidate, REYOBIQ™. With its diagnostics platform, CNSide®, now securing national coverage for over 67 million people through agreements with UnitedHealthcare and Humana, are the commercial revenue streams finally starting to balance the Q3 2025 operating loss of $4.5 million?

Plus Therapeutics, Inc. (PSTV) History

The history of Plus Therapeutics, Inc. is a story of a major strategic pivot, transforming an older company focused on cell therapy into a clinical-stage radiotherapeutics firm. You need to understand that the company you see today isn't the one that started in 1996; it's a completely different entity built on an acquired technology and a new vision for treating central nervous system (CNS) cancers.

Given Company's Founding Timeline

Year established

The original entity, Cytori Therapeutics, Inc., was founded in 1996. The company officially became Plus Therapeutics, Inc. following a strategic shift and name change in July 2019.

Original location

The company is headquartered in Houston, Texas, which is a key hub for cancer clinical development.

Founding team members

The original company, Cytori Therapeutics, was founded by Ralph E. Holmes and Christopher J. Calhoun in 1996. The strategic transformation into Plus Therapeutics was led by key executives like Dr. Marc H. Hedrick, M.D., who serves as President and CEO.

Initial capital/funding

Specific initial capital for the 1996 founding is not publically detailed, but recent capital raises underscore the current focus. For example, the company secured a private placement in 2025 with gross proceeds expected to be approximately $15.0 million to advance its CNS cancer therapies. Also, a significant non-dilutive grant from the Cancer Prevention and Research Institute of Texas (CPRIT) for $17.6 million supports the development of their lead therapeutic.

Given Company's Evolution Milestones

Year Key Event Significance
1996 Cytori Therapeutics, Inc. Founded Established the original corporate structure.
2017 Acquired Nanomedicine Platform Secured the core technology for Rhenium-186 Nanoliposome (REYOBIQ™).
July 2019 Name Changed to Plus Therapeutics, Inc. Completed the strategic pivot away from cell therapy to focus on targeted radiotherapeutics.
2020 Initiated ReSPECT-GBM Phase 1 Trial Began clinical evaluation of REYOBIQ™ for recurrent glioblastoma (GBM).
2021 FDA Orphan Drug Designation for GBM Gained regulatory support for REYOBIQ™ in treating glioblastoma, a key market.
March 2025 FDA Orphan Drug Designation for LM Secured a second Orphan Drug Designation for Rhenium Obisbemeda, this time for leptomeningeal metastases (LM) in lung cancer.
Q2 2025 Reported Net Income of $5.15 million Achieved a pivotal turnaround, marking its first quarterly profitability after 17 consecutive quarterly losses.
Sept 2025 UnitedHealthcare National Coverage for CNSide® Secured national payer coverage for its diagnostic test, covering over 51 million people.
Nov 2025 Humana National Coverage for CNSide® Signed a second national agreement, increasing total policy coverage for the test to approximately 67 million people.

Given Company's Transformative Moments

The company's trajectory has been defined by a few high-stakes, transformative decisions. Honestly, the biggest one was ditching the old business model entirely.

  • The 2019 Strategic Pivot: The decision to divest the autologous cell therapy assets and change the name to Plus Therapeutics, Inc. in 2019 was a clean break. It moved the company from a broad, capital-intensive cell therapy space to the specialized, high-unmet-need area of targeted radiotherapeutics for CNS cancers.
  • Acquiring the Rhenium Nanoliposome Technology: This acquisition in 2017, which led to the development of REYOBIQ™ (rhenium Re-186 obisbemeda), gave them a truly differentiated asset. This is a complex, image-guided local beta radiation therapy, not just another pill.
  • The Q2 2025 Profitability Turnaround: Reporting a net income of $5.15 million in the second quarter of 2025, a 275.2% increase from the prior year's loss, was a critical moment. This wasn't driven by drug sales-total revenue for the quarter was $1.39 million, all from grant funding-but it showed a temporary financial stabilization and an ability to manage the business.
  • Commercial Launch of CNSide®: The commercialization of the CNSide® diagnostic assay in 2025, securing national coverage agreements with UnitedHealthcare and Humana, is a fundamental shift. This is the company's first real revenue-generating product, covering over 67 million people, which provides a commercial foundation while the therapeutic pipeline, REYOBIQ™, moves through trials. It's defintely a smart move to diversify risk.

To understand the core focus that drives these decisions, you should review their forward-looking strategy: Mission Statement, Vision, & Core Values of Plus Therapeutics, Inc. (PSTV).

Plus Therapeutics, Inc. (PSTV) Ownership Structure

Plus Therapeutics, Inc.'s ownership structure is heavily weighted toward retail investors, which is typical for a clinical-stage biotechnology company still in its growth phase. This concentration means the stock price can be more volatile, but it also gives individual investors a greater collective voice than in a mega-cap stock.

Plus Therapeutics, Inc.'s Current Status

Plus Therapeutics, Inc. is a publicly traded, clinical-stage pharmaceutical company focused on targeted radiotherapeutics for central nervous system (CNS) cancers. It is listed on the Nasdaq Capital Market (NasdaqCM) under the ticker symbol PSTV.

The company successfully addressed a critical regulatory challenge in August 2025 by reporting stockholders' equity of $3 million as of June 30, 2025, exceeding the Nasdaq minimum requirement of $2.5 million. Still, you should know they remain under a Mandatory Panel Monitor through March 2026, which is a sign of ongoing regulatory scrutiny of their financial health. You need to keep a close eye on their cash runway; in March 2025, their cash balance of $9.9 million suggested a runway of about nine months based on the prior year's burn rate.

For a deeper dive into the company's long-term direction, you can review the Mission Statement, Vision, & Core Values of Plus Therapeutics, Inc. (PSTV).

Plus Therapeutics, Inc.'s Ownership Breakdown

As of November 2025, the vast majority of Plus Therapeutics, Inc. shares are held by the general public, giving them outsized influence on the stock's trading dynamics. Institutional holdings are small, but they include major players like The Vanguard Group and BlackRock Inc.

Shareholder Type Ownership, % Notes
General Public (Retail) 94.72% Represents individual investors; contributes to higher stock volatility.
Institutional Investors 4.97% Includes mutual funds, pension funds, and major asset managers like The Vanguard Group, Inc. and BlackRock, Inc.
Individual Insiders 0.31% Management and Board of Directors; insiders have shown buying activity in the last three months of 2025.

Here's the quick math: Institutional investors hold roughly 6.8 million shares, while insiders hold about 425,000 shares, based on the total shares outstanding. Insider buying has actually outpaced selling recently, which is a defintely positive signal for a clinical-stage company.

Plus Therapeutics, Inc.'s Leadership

The leadership team steering Plus Therapeutics, Inc. is a mix of seasoned biotech executives and specialized directors, focused on advancing their targeted radiotherapeutics pipeline. The CEO, Marc Hedrick, has a long tenure, providing stability, but also a long track record to scrutinize.

  • Marc Hedrick, MD, MBA: President and Chief Executive Officer (CEO). His total yearly compensation is approximately $1.26 million, as of September 2025.
  • Andrew Sims, CPA: Vice President and Chief Financial Officer (CFO). He has been actively buying shares in November 2025.
  • Russ Havranek, MS MBA: Executive Vice President (EVP), Commercial and Corporate Strategy.
  • Russell Bradley: President and General Manager of the wholly-owned subsidiary, CNSide Diagnostics, LLC, appointed in February 2025.

The Board of Directors is chaired by Richard Hawkins and includes industry veteran Kyle Guse, J.D., M.B.A., who joined in April 2025 to chair the Audit Committee, bringing 30 years of financial and operational expertise to the table. The average tenure for the management team is 5.8 years, suggesting a stable, experienced core.

Plus Therapeutics, Inc. (PSTV) Mission and Values

Plus Therapeutics, Inc. is driven by a singular, profound purpose: to transform the treatment landscape for central nervous system (CNS) cancers, a notoriously defintely challenging area in oncology. Their mission and values center on harnessing the power of precision radiotherapeutics to deliver better patient outcomes.

You're looking for what makes this clinical-stage biotech tick beyond its balance sheet, and it's a clear commitment to tackling the hardest-to-treat cancers, like recurrent glioblastoma and leptomeningeal metastases (LM).

Given Company's Core Purpose

Plus Therapeutics' core purpose is to bring a new class of targeted radiation treatments to patients who currently have limited options. This focus is critical, especially when you consider that survival curves for brain and CNS cancers have largely remained flat over the last 40 years, unlike most other cancers.

Here's the quick math on their commitment: they are a small company with a market capitalization of just $12.75 million as of April 14, 2025, yet they are tackling a problem that requires tens of millions in non-dilutive funding, which they've secured through grants like the $17.6 million CPRIT award.

Official Mission Statement

The company's mission is precise and action-oriented. It's about solving the problem of delivery in cancer care, ensuring the treatment is as effective as possible while minimizing collateral damage.

  • Solve the toughest challenges in oncology by improving the efficacy, precision, and convenience of radiotherapeutics.
  • Develop and commercialize innovative, targeted radiotherapeutics for difficult-to-treat cancers.
  • Focus on therapies with the potential to improve patient outcomes and quality of life.

Vision Statement

The vision for Plus Therapeutics is not just incremental improvement; it's about establishing a new benchmark for cancer therapy. They want their innovative radiotherapeutics to move from promising pipeline candidates to standard medical practice.

  • Envision innovative radiotherapeutics that become a global standard of care for cancer.
  • Lead the charge in bending the survival curve for brain and central nervous system cancers.
  • Achieve economic drug development, rapidly advancing candidates in a cost-effective manner.

What this estimate hides is the binary nature of clinical-stage biotech; success in their ReSPECT-LM trial, initiated in Q2 2025, is the key that unlocks this vision. You can dig into the financial implications of that risk in Breaking Down Plus Therapeutics, Inc. (PSTV) Financial Health: Key Insights for Investors.

Given Company Slogan/Tagline

Their tagline encapsulates the core value proposition of their Rhenium-186 Nanoliposome (REYOBIQ™) platform: a focused, high-impact approach to tumor eradication.

  • The power of precision in radiotherapeutics.

This idea of precision is what differentiates them, allowing for a single, safe, and effective dose of radiation delivered directly to the tumor while sparing healthy tissue. That's the kind of clear-cut value proposition that matters to clinicians and, ultimately, to investors.

Plus Therapeutics, Inc. (PSTV) How It Works

Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for difficult-to-treat central nervous system (CNS) cancers, combining image-guided local radiation with precise drug delivery.

While the core of their future revenue is tied to the clinical success of their drug pipeline, the company currently generates revenue primarily from research grants and the commercialization of its proprietary diagnostic testing service, CNSide, which is a crucial part of their dual-track strategy to address unmet needs in CNS oncology.

Plus Therapeutics, Inc.'s Product/Service Portfolio

Product/Service Target Market Key Features
Rhenium (186Re) Obisbemeda (REYOBIQ) Patients with CNS cancers: recurrent glioblastoma (GBM), leptomeningeal metastases (LM), pediatric brain cancers. Patented targeted radiotherapeutic; image-guided local beta radiation; Orphan Drug Designation secured for one indication.
CNSide® CSF Tumor Cell Enumeration (TCE) Assay Oncologists and healthcare professionals treating patients with metastatic CNS cancer. Laboratory-developed test (LDT) with 92% sensitivity and 95% specificity; quantitative analysis of cerebrospinal fluid (CSF); supports rapid diagnosis and treatment monitoring.

Plus Therapeutics, Inc.'s Operational Framework

The company operates on a hybrid virtual drug development model, which is a smart way to enhance efficiency and control the massive costs typical of a biotech company.

  • Capital-Efficient Model: They maintain a lean internal team and outsource a large portion of research and development (R&D), clinical trials, and even manufacturing to specialized contract organizations.
  • Revenue Generation: As a clinical-stage entity, product sales are not yet a primary revenue source; for the third quarter of 2025, reported revenue was $1.40 million, mainly from grants and diagnostic services.
  • Financial Runway: Management has publicly stated they have sufficient cash runway to fund operations into late 2026, based on their current burn rate, which gives them a defintely needed cushion for clinical progress.
  • Commercialization of Diagnostics: The CNSide diagnostic test, which is already commercial, is a key revenue driver, with its policy coverage expanding to approximately 67 million people in the U.S. as of November 2025, following a new agreement with Humana, Inc..

Here's the quick math: With a forecasted annual EBITDA of -$12 million for the 2025 fiscal year, maintaining a capital-efficient structure is not optional; it's essential for survival and advancing the pipeline.

Plus Therapeutics, Inc.'s Strategic Advantages

Their market success hinges on a few core differentiators that address the high-risk nature of CNS cancer treatment.

  • Targeted Radiotherapeutics Platform: The use of Rhenium-186 in their lead candidate, REYOBIQ, allows for highly localized, image-guided beta radiation, aiming to maximize tumor cell kill while minimizing damage to surrounding healthy brain tissue. This precision is a major clinical advantage.
  • Orphan Drug Exclusivity: Securing an Orphan Drug Designation from the FDA for one of their treatments provides significant benefits, including a potential seven years of market exclusivity upon approval, plus tax credits and exemptions from certain regulatory fees.
  • Integrated Diagnostics and Therapy: They are pursuing a dual-track strategy by developing the therapeutic (REYOBIQ) alongside the diagnostic platform (CNSide), which is already influencing treatment decisions in 90% of cases where it is used. This integration creates a unique value proposition for clinicians.
  • Non-Dilutive Funding: Strategic partnerships and grants, such as the multi-million dollar program with the Cancer Prevention and Research Institute of Texas (CPRIT), help fund expensive clinical trials without immediately diluting shareholder value, which is critical for a company with a market capitalization around $70.5 million as of November 2025.

To be fair, the company's long-term value is still tied to the successful completion of its clinical trials. For more on the company's guiding principles, you can review their Mission Statement, Vision, & Core Values of Plus Therapeutics, Inc. (PSTV).

Plus Therapeutics, Inc. (PSTV) How It Makes Money

Plus Therapeutics, Inc. is currently a clinical-stage oncology company that primarily generates revenue through non-dilutive government and institutional research grants, which fund the development of its lead radiotherapeutic drug candidate, REYOBIQ™. The company is just starting to transition toward commercial revenue through its CNSide® diagnostic service, a cerebrospinal fluid (CSF) assay for central nervous system (CNS) cancers.

Plus Therapeutics' Revenue Breakdown

As a development-stage biotech, the company's revenue profile in the 2025 fiscal year is highly concentrated in grant funding, reflecting the high-cost nature of clinical trials and the pre-commercial status of its therapeutic pipeline. For the third quarter of 2025, total reported revenue was $1.40 million, almost entirely derived from grants.

Revenue Stream % of Total (Q3 2025) Growth Trend
Grant Revenue (CPRIT, DoD) ~100% Stable/Decreasing
CNSide® Service Revenue <1% Increasing

The Grant Revenue stream, which includes funds from the Cancer Prevention and Research Institute of Texas (CPRIT) for REYOBIQ™ development, accounted for approximately $1.4 million in Q3 2025. This grant amount was slightly lower than the same period in 2024, indicating a 'Stable/Decreasing' trend in this specific funding source. The CNSide® Service Revenue, while currently negligible, is on a clear 'Increasing' trend following its commercial launch in Texas in August 2025 and a national coverage agreement with UnitedHealthcare effective September 15, 2025.

Business Economics

The core economic engine is a high-risk, high-reward model typical of clinical-stage biotechnology, but with a recent, lower-risk diagnostic component. The company's primary value driver is its proprietary radiotherapeutic platform, which uses nanoliposomes to deliver Rhenium-186 (REYOBIQ™) directly to CNS tumors, bypassing the blood-brain barrier.

  • Cost Structure: The business is dominated by fixed costs, primarily Research and Development (R&D) expenses for clinical trials like ReSPECT-LM and ReSPECT-GBM, plus general and administrative costs.
  • Therapeutic Pricing: The pricing strategy for REYOBIQ™ is not yet public, but as a novel, targeted radiotherapeutic for rare, difficult-to-treat cancers like leptomeningeal metastases (LM), it will defintely command a premium price upon regulatory approval, reflecting its potential to significantly extend life in a high-unmet-need market.
  • Diagnostic Pricing: The CNSide® CSF Assay is a Laboratory Developed Test (LDT), meaning its pricing is set to cover the cost of the service and generate a margin, supported by a growing number of payer contracts like the one with UnitedHealthcare, which covers over 51 million people. This diagnostic platform provides a near-term, recurring revenue stream to help offset R&D burn.
  • Grant Leverage: Non-dilutive grants, such as the $17.6 million CPRIT award, are crucial for funding R&D without issuing more stock, thereby preserving shareholder equity.

Plus Therapeutics' Financial Performance

The company's financial performance as of late 2025 reflects its status as a company investing heavily in its clinical pipeline while initiating its first commercial product launch. The focus remains on cash management and clinical milestones over short-term profitability.

  • Trailing Twelve Months (TTM) Revenue: Total revenue for the twelve months ending September 30, 2025, was approximately $5.26 million, a year-over-year decrease of -8.16%.
  • Operating Loss: The operating loss for the third quarter of 2025 was $4.5 million, primarily due to the costs associated with advancing the REYOBIQ™ clinical trials.
  • Net Loss: The net loss for Q3 2025 was $4.4 million, or a loss of $0.04 per share.
  • Cash Position: The cash and investments balance stood at a stronger $16.6 million as of September 30, 2025, up significantly from the start of the year, providing a critical cash runway to fund operations into 2026.
  • EBITDA Forecast: Analysts forecast the company's annual Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) for the full fiscal year 2025 to be a loss of -$12 million.

The financial picture is clear: the company is burning cash to advance its therapeutic pipeline, but the recent commercialization of CNSide® and a strengthened cash position provide a more stable foundation. You can read more about the company's long-term goals in its Mission Statement, Vision, & Core Values of Plus Therapeutics, Inc. (PSTV).

Next step: Monitor Q4 2025 reports for the first material revenue contribution from the CNSide® diagnostic platform, which will signal the success of the commercial launch.

Plus Therapeutics, Inc. (PSTV) Market Position & Future Outlook

Plus Therapeutics, Inc. (PSTV) is strategically positioned as a high-risk, high-reward play in the severely underserved central nervous system (CNS) cancer market, leveraging a dual-platform strategy that combines a novel diagnostic with a targeted radiotherapeutic pipeline.

The company's near-term outlook is anchored by the commercialization of its CNSide® diagnostic platform and the advancement of its lead therapeutic candidate, REYOBIQ™ (rhenium Re186 obisbemeda), which is targeting the $844.8 million glioblastoma treatment market and the highly unmet need in leptomeningeal metastases (LM) as of 2025.

Competitive Landscape

As a clinical-stage company, Plus Therapeutics' current revenue, forecast at approximately $5.258 million for the 2025 fiscal year, is primarily grant-based and from its diagnostic service, giving it a negligible market share of the overall $1.92 billion U.S. radiopharmaceutical therapies market.

The real competition is in the pipeline, where Plus Therapeutics' unique approach-delivering high-dose, localized radiation via nanoliposomes-competes against other novel mechanisms in neuro-oncology.

Company Market Share, % Key Advantage
Plus Therapeutics <1.0% Targeted Rhenium-186 nanoliposome delivery (REYOBIQ™) and dual diagnostic/therapeutic platform (CNSide®).
Kazia Therapeutics <1.0% Paxalisib (PI3K/AKT/mTOR inhibitor) for GBM/LM, a small molecule drug designed to cross the blood-brain barrier.
Y-mAbs Therapeutics <1.0% Omburtamab (radiolabeled monoclonal antibody) for CNS tumors, offering a different targeted radiation mechanism.

Opportunities & Challenges

You're looking at a company with a clear, vertically integrated strategy, but one that faces the inherent volatility of a clinical-stage biotech. The immediate opportunities are commercial, but the long-term value is tied to clinical trial success.

Opportunities Risks
CNSide® Commercial Traction: National coverage for the diagnostic assay now covers over 67 million people (UnitedHealthcare and Humana agreements in late 2025). Liquidity and Cash Burn: Q3 2025 operating loss was $4.5 million, requiring continued capital raises or non-dilutive funding.
REYOBIQ™ Clinical Progress: Positive Phase 1 data for ReSPECT-LM showed a promising efficacy signal and favorable safety profile, paving the way for pivotal trials. Regulatory Hurdles: Need to successfully clarify the clinical development and pivotal trial plan for REYOBIQ™ with the FDA.
Non-Dilutive Funding: Secured a significant $17.6 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) for therapeutic advancement. Nasdaq Compliance: Received a 180-day extension in November 2025 to regain compliance with the $1.00 minimum bid price requirement.

Industry Position

Plus Therapeutics holds a unique position in the neuro-oncology space because of its two-pronged approach: diagnose first, then treat. This vertical integration is a defintely a key differentiator.

  • Niche Focus: The company focuses exclusively on difficult-to-treat CNS cancers like recurrent glioblastoma (GBM) and leptomeningeal metastases (LM), areas with high unmet medical need and no approved therapies for LM.
  • Diagnostic Advantage: The CNSide® Cerebrospinal Fluid (CSF) Assay Platform is a first-mover in providing highly sensitive (92%) and specific (95%) tumor cell enumeration, which can influence treatment decisions in 90% of cases.
  • Therapeutic Innovation: REYOBIQ's direct intratumoral or intrathecal delivery of Rhenium-186 nanoliposomes is designed to bypass the blood-brain barrier and deliver a highly localized, high-dose of radiation, which is a novel mechanism in the field.
  • Financial Reality: As of September 30, 2025, the company had $16.6 million in cash and investments, a critical metric for a clinical-stage firm with a high burn rate.

The successful commercial launch of CNSide and its growing coverage is providing an early, recurring revenue stream, which is rare for a biotech primarily focused on Phase 1/2 therapeutic trials. You can see more details on the ownership structure and institutional stakes here: Exploring Plus Therapeutics, Inc. (PSTV) Investor Profile: Who's Buying and Why?

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