iHub News
2時間前
Plus Therapeutics to rebrand as Cerenome and adopt CNSY ticker on August 3 (PSTV)June 30, 2026 8:49 AM
IH Market News Company confirms name change and reaffirms 2026 objectives Plus Therapeutics, Inc. (NASDAQ:PSTV), a healthcare company focused on central nervous system cancers, announced it will rebrand as Cerenome and begin trading on the Nasdaq under the new ticker symbol CNSY on August 3, 2026. The company said shareholders do not need to take any action as a result of the name and ticker change. Alongside the rebranding announcement, Plus Therapeutics reaffirmed its 2026 milestone guidance and highlighted continued commercial momentum for its CNSide diagnostics platform. CNSide expands insurance coverage and testing volumes The company said contracted insurance coverage for CNSide has increased to approximately 126 million covered lives after securing new agreements with Highmark, Blue Shield of California and Elevance Health, compared with around 67 million at the beginning of 2026. Management remains on track to surpass 150 million covered lives by the end of the year. A total of 232 CNSide tumour cell enumeration tests have been performed year-to-date, with June delivering a record monthly volume of 72 tests. The company is targeting an annualised run rate of 1,250 tests by the close of 2026. CNSide Diagnostics also received its Medicare Provider Transaction Access Number on May 7, 2026, while a dedicated billing code is scheduled to become effective on July 1, 2026. Clinical programmes continue to advance For its lead therapeutic candidate, REYOBIQ (rhenium-186 obisbemeda), Plus Therapeutics reported that 31 of the planned 34 patients have now been enrolled in the Phase 2 ReSPECT-GBM trial. The Phase 2 ReSPECT-LM study has enrolled approximately one-third of its target population of between 12 and 18 patients for optimal dose determination. The company also expects to administer the first dose in the ReSPECT-PBC paediatric brain cancer trial during the third quarter of 2026 after receiving approvals from the U.S. Department of Defense and an Institutional Review Board. In May 2026, Plus Therapeutics entered into an agreement with Ephemeral Technologies to support the development of its data and artificial intelligence infrastructure. Marc H. Hedrick, M.D., President and Chief Executive Officer, said the Cerenome name reflects the company’s identity as “an integrated CNS oncology platform company designed to combine therapeutic interventions, diagnostic insights and advanced data analytics.” Plus Therapeutics stock priceThe post Plus Therapeutics to rebrand as Cerenome and adopt CNSY ticker on August 3 (PSTV) appeared first on US Editors. Original: Plus Therapeutics to rebrand as Cerenome and adopt CNSY ticker on August 3 (PSTV)
Paulness
5日前
NEWS -- Plus Therapeutics Secures National Coverage Agreement with Elevance Health for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer
HOUSTON, June 25, 2026 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), announced today that it has signed a national agreement with Elevance Health, Inc. (NYSE: ELV), effective May 1, 2026, covering approximately 45.4 million people throughout the United States, to provide the CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) assay. This brings CNSide CSF TCE assay total contracted coverage to 126 million people.
The CNSide® CSF Assay Platform supports rapid diagnoses, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases. The superior clinical utility of CNSide® over standard of care has been shown in 9 peer-reviewed publications, the FORESEE clinical trial, and has been validated in the market through real-world use.
More than 11,000 CNSide® tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases.
This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
About Elevance Health
Elevance Health is a lifetime, trusted health partner whose purpose is to improve the health of humanity. The company supports consumers, families, and communities across the entire healthcare journey – connecting them to the care, support, and resources they need to lead better lives. Elevance Health's companies serve approximately 105 million consumers through a diverse portfolio of industry-leading medical, pharmacy, behavioral, clinical, home health, and complex care solutions. For more information, please visit https://www.elevancehealth.com or follow us @ElevanceHealth on X and Elevance Health on LinkedIn.
Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "potential," "anticipating," "planning" and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential market for the CNSide CSF Assay, the timing in which the CNSide CSF Assay is commercially launched and commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay and expectations as to the Company's future performance, including the next steps in developing the Company's product candidates.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
1週前
NEWS -- Plus Therapeutics to Provide Business Update Call on June 30, 2026
Management to update on 2026 mid-year progress, milestones and provide details on its integrated CNS oncology strategy and artificial intelligence plans
HOUSTON, June 23, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company focused on central nervous system ("CNS") cancers, today announced that management will host a business update conference call and webcast on Tuesday, June 30, 2026, at 8:30 a.m. Eastern Time.
During the call, management will focus on the Company's CNSide® diagnostic launch and its integrated development plan for lead drug Reyobiq. Furthermore, management will provide further detail on its CNS oncology strategy and native artificial intelligence development plans.
"Our team is making substantial progress in all 3 areas of the company, specifically diagnostics, therapeutics and artificial intelligence," said Marc H. Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. "We are excited to provide an update on our progress toward our milestones and vision for the company to enable better outcomes for CNS oncology patients and provide long-term value creation for stockholders."
Conference Call and Webcast Details
Date: Tuesday, June 30, 2026
Time: 8:30 a.m. Eastern Time
Webcast: Link
Dial-in (U.S./Canada): 1-888-349-0106
Dial-in (International): 1-412-317-6789
A replay of the webcast will be available following the event in the Investor Relations section of the Company's website at https://www.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics is a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for CNS cancers. The Company's lead therapeutic platform is anchored by REYOBIQ™, and its diagnostics strategy includes the CNSide® cerebrospinal fluid assay platform, which is designed to support the management of patients with CNS cancers. Plus is also advancing an integrated data strategy intended to connect therapeutic, diagnostic, and bioinformatic insights across its CNS oncology programs.
Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws, including statements regarding clinical operations, expected commercial activities, and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "potential," "anticipate," "intend," "believe," "estimate," "plan," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate.
These statements include, without limitation, statements regarding the anticipated benefits of CAP accreditation, the potential market for the CNSide® CSF Assay Platform, the timing and pace of U.S. commercial launch and expansion, expectations regarding payor coverage, reimbursement, and billing code expansion for the CNSide® CSF Assay, the development and clinical utility of the CNSide CSF Assay, and expectations as to the Company's future performance, including next steps in developing the Company's product candidates.
The forward-looking statements included in this press release could differ materially from those expressed or implied because of risks, uncertainties, and other factors that include, but are not limited to: the Company's ability to maintain regulatory accreditations and certifications; the Company's ability to successfully commercialize the CNSide CSF Assay Platform; the Company's ability to obtain and maintain favorable coverage, reimbursement, and billing codes from commercial and government payors; the Company's ability to complete its pre-clinical or clinical studies; available cash on hand; the Company's ability to raise additional capital on reasonable terms or at all; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete.
Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect the Company's business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC's website at www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
1月前
NEWS -- Plus' CNSide Diagnostic Platform Demonstrates Substantial Healthcare Cost Reduction in Patients with Leptomeningeal Metastases
Plus and Harvard analysis shows CNSide enables early diagnosis and better clinical decision-making
reducing healthcare costs by 40%
Presentation receives blue-ribbon recognition at the ISPOR Annual Meeting, the premier global gathering for health economics and outcomes research
HOUSTON, May 26, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced the presentation of a new health economics study evaluating the economic impact of earlier detection and therapeutic management of LM using the CNSide cerebrospinal fluid (CSF) assay. The Company believes that this cost-of-care analysis underscores that earlier LM diagnosis and therapeutic management enabled by CNSide may reduce overall LM-related healthcare costs by approximately 33-47%. These savings are driven by earlier therapeutic intervention, improved treatment precision, and reduced hospitalizations. Further, the recently announced payer agreements validate the findings as Plus continues commercialization of the assay in the United States.
The data was presented at the ISPOR 2026 Annual Meeting, the leading global scientific conference focused on health economics and outcomes research (HEOR), bringing together researchers, healthcare decision-makers, and payer stakeholders. The meeting took place May 17-20, 2026, in Philadelphia, PA.
“These findings are confirmation of discussions we have had with payers regarding the value provided by CNSide’s ability to detect and monitor tumor cells in cerebrospinal fluid, providing clinicians with actionable information earlier in the disease course,” said Randy Goodman, Ph.D., MHA, Vice President of Value Strategy & HEOR. “Health economics data are an important determinant in payer decision making and these data suggest the potential cost savings associated with earlier intervention and optimized management.”
Presentation Highlights
The poster, titled, “Economic Impact of Earlier Detection and Therapeutic Management of Leptomeningeal Metastases Using CNSide: A Cost-of-Care Analysis,” co-authored by CNSide Diagnostics and Harvard T.H. Chan School of Public Health, highlighted the following:
Late-stage LM diagnosis is associated with substantial healthcare costs, including median inpatient admissions of ~$20,000 (Interquartile range (IQR) $10,000-$30,000)
Total LM-related costs may exceed $100,000 per month, driven by repeated imaging, LM-directed therapies, and palliative care
Earlier detection and treatment optimization enabled by CNSide may reduce overall LM-related healthcare costs by ~40% (33%-47%)
Potential savings are driven by earlier therapeutic intervention, improved treatment precision, reduced adverse events and hospitalizations, and potential improvements in quality-adjusted outcomes
The analysis also highlights the challenges of quantifying LM costs due to claims bundling with primary cancer treatmentNotably, the poster received Blue Ribbon recognition, an honor awarded to the top 5% of presentations at ISPOR. The analysis utilized published literature, real-world data, and healthcare claims databases to estimate direct and indirect costs associated with late-stage LM diagnosis. Additional information on ISPOR 2026 and the poster can be found here.
About Leptomeningeal Metastases
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid (CSF) that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers. The Company’s commercial diagnostic, CNSide®, is a high-complexity cerebrospinal fluid (CSF) assay platform that supports the detection and management of leptomeningeal metastases (LM). The Company’s lead therapeutic candidate, REYOBIQ™ (rhenium Re186 obisbemeda), is in clinical development for LM and recurrent glioblastoma (GBM), combining image-guided local beta radiation with targeted drug delivery. Plus has built a supply chain through strategic partnerships that enable the development, manufacturing, and potential future commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to commercialize CNSide and to achieve and sustain payer coverage and reimbursement for the assay; the timing, scope and outcomes of the Company’s clinical studies, including ReSPECT-LM and ReSPECT-GBM; the Company’s ability to obtain regulatory approvals; the Company’s reliance on third-party manufacturers and supply chain partners; the Company’s ability to raise additional capital on reasonable terms or at all; available cash on hand; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
1月前
NEWS -- Plus Therapeutics Partners with Ephemeral Technologies to Deploy AI Execution Platform for CNS Oncology
Partnership to deliver a novel AI-native integrated CNS oncology platform
Platform will unify and analyze Plus’ proprietary therapeutic, diagnostic, and bioinformatics datasets to accelerate precision neuro-oncology
HOUSTON, May 19, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics for central nervous system (CNS) cancers, today announces that it has signed an agreement to enter into a strategic partnership with Ephemeral Technologies (“Ephemeral”) to deliver a unique AI execution platform for CNS oncology. The AI execution platform is designed to integrate, organize, and derive actionable intelligence from longitudinal therapeutic, diagnostic and bioinformatic data sets generated across Plus’ CNS oncology technology programs.
“Plus is building a CNS oncology platform to integrate across our therapeutics, diagnostics and bioinformatics data sets,” said Marc Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “Our partnership with Ephemeral and its expertise in deploying artificial intelligence brings industry-proven engineering and advanced AI capabilities to the most challenging area of oncology. This partnership is intended to help further position Plus as a leader in CNS oncology and accomplish our mission of improving survival for patients with the most devastating cancers.”
Ephemeral was founded by the former co-heads of Palantir Technologies’ U.S. healthcare business. Ephemeral was launched to bring AI solutions to life sciences to accelerate drug development.
Plus and Ephemeral believe the combination of multi-modal, longitudinal data with generative AI reasoning and agentic workflows will create both near- and long-term value for shareholders. Beginning in 2026, Plus anticipates tangible improvements in both laboratory and clinical operating efficiency and workflows. Beyond 2026, Plus intends to increasingly use artificial intelligence for fully integrated operational workflows, operational decision support, translational and treatment response analytics, patient stratification, precision oncology initiatives, pharmaceutical collaborations and real-world evidence initiatives.
“Ephemeral was founded to help companies like Plus align AI to real scientific and operational execution to more quickly deliver better medicines to patients,” said Drew Goldstein, Ephemeral Co-Founder and Co-Chief Executive Officer. “Plus’ unique positioning and data sets in CNS oncology represents an ideal opportunity for Ephemeral, and we are proud to leverage our technology to support Plus’ mission to help patients with CNS cancers.”
Under the agreement, Plus Therapeutics and Ephemeral will assess and implement AI-enabled data infrastructure to support the integration, organization, and analysis of complex CNS oncology data sets generated through the Company’s therapeutic and diagnostic workflows. No financial terms of the agreement were disclosed.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Ephemeral Technologies, Inc.
Ephemeral Technologies, Inc. is building systems to align AI with real scientific and operational execution to accelerate the development and delivery of effective medicines to give people more time. Additional information is available at https://www.ephemeral.now.
Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate," "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company's ability to maintain the listing of its common stock on Nasdaq, including following the 1-for-25 reverse stock split effected April 2, 2026; the early stage of the Company's product candidates and therapies; the results of the Company's research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies, and the timing and outcome of the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-PBC trials; the Company's liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company's partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production, and distribution capabilities necessary to support the Company's clinical trials and any commercial level product demand; statements regarding the potential market for the CNSide CSF Assay Platform, the timing in which the CNSide CSF Assay commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay, and expectations as to the Company's future performance, including the next steps in developing the Company's product candidates; and material security breach or cybersecurity attack affecting the Company's operations or property. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics' business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics' annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC's website at https://www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations, and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor/Media Contacts
Plus Therapeutics, Inc.
CORE IR
mailto://investor@plustherapeutics.com
Ephemeral Technologies, Inc.
mailto://contact@ephemeral.now
Paulness
2月前
NEWS -- Plus Therapeutics Announces Oral Presentation Highlighting REYOBIQ™ Clinical and Translational Data Demonstrating Favorable Safety, Survival, and Emerging Immunomodulation in Leptomeningeal Metastases
Plenary session at AANS underscores REYOBIQ’s potential as a differentiated targeted radiotherapeutic platform for CNS cancers
HOUSTON, Texas, May 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces a plenary session reviewing key clinical and translational data, including the Phase 1 ReSPECT-LM trial of REYOBIQ™ (rhenium Re186 obisbemeda) was presented at the 2026 American Association of Neurological Surgeons (AANS) Annual Scientific Meeting taking place May 1-4, 2026 in San Antonio, Texas.
“This oral plenary session, which reviewed data collected to date, and included an overview of the ReSPECT-LM single dose escalation study, is an important validation of the clinical and translational evidence supporting REYOBIQ as a differentiated therapeutic approach for patients with leptomeningeal metastases, a devastating condition with no FDA-approved therapies. AANS is an important congress, and we are encouraged by these data being featured in such a prominent part of the conference,” said Eric J. Daniels, M.D., M.B.A., Plus Therapeutics Chief Development Officer. “We continue to believe strongly in the potential of REYOBIQ in the clinical setting as we continue the ongoing multiple dose trial.”
The oral presentation, titled, “¹86Rhenium-Nanoliposomes (¹86RNL) for the Treatment of Leptomeningeal Metastases: Translational Insights from Clinical and Preclinical Models,” was delivered by Henriette U. Balinda, PhD, of UT Health San Antonio in a Plenary Session on Saturday, May 2, 2026.
Key Data Highlights
The Presentation highlighted the completed Phase 1 ReSPECT-LM study demonstrating:
Encouraging survival outcomes, with median overall survival of approximately 9 months in patients treated at the recommended Phase 2 dose, compared to historical survival of approximately 2–6 months
Robust anti-tumor activity, including high rates of circulating tumor cell (CTC) reduction and clinical benefit across evaluable patients
Favorable safety and tolerability profile, supporting advancement into later-stage clinical development
Highly targeted radiation delivery, with a target-to-off-target absorbed dose ratio exceeding 100:1, minimizing exposure to healthy tissueIn addition, translational analyses presented in the session demonstrate that REYOBIQ may induce immune remodeling within the tumor microenvironment, including activation of CD8+ T cells and enhancement of anti-tumor immune response, supporting potential future combination strategies with immunotherapies.
Currently, the ReSPECT-LM Phase 1 Multiple Dose trial is underway and enrolling patients at the University of Texas Health San Antonio. The primary objectives include characterizing safety and tolerability of multiple doses at defined intervals of REYOBIQ for patients of any primary solid tumor cancer with LM.
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate," "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments, and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company's ability to maintain the listing of its common stock on Nasdaq, including following the 1-for-25 reverse stock split effected April 2, 2026; the early stage of the Company's product candidates and therapies; the results of the Company's research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies, and the timing and outcome of the ReSPECT-LM, ReSPECT-GBM, and ReSPECT-PBC trials; the Company's liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company's partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production, and distribution capabilities necessary to support the Company's clinical trials and any commercial level product demand; statements regarding the potential market for the CNSide CSF Assay Platform, the timing in which the CNSide CSF Assay commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay, and expectations as to the Company's future performance, including the next steps in developing the Company's product candidates; and material security breach or cybersecurity attack affecting the Company's operations or property. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics' business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics' annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC's website at https://www.sec.gov. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations, and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Receives Medicare Enrollment Approval for CNSide Diagnostic
Enables billing under traditional Medicare and creates a pathway to ~35 million Medicare Advantage beneficiaries through future payer coverage decisions
HOUSTON, May 07, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced that its wholly owned subsidiary, CNSide Diagnostics, LLC (“CNSide Diagnostics”), has successfully enrolled in the Medicare program and received a Provider Transaction Access Number (PTAN) from the Centers for Medicare & Medicaid Services (CMS).
This key milestone establishes CNSide Diagnostics as a Medicare-enrolled clinical laboratory, enabling the submission of claims for its CNSide® Cerebrospinal Fluid (CSF) Assay Platform, including the tumor cell enumeration (TCE) test. Claims will be reimbursed when determined to be reasonable and necessary by the Medicare Administrative Contractor (MAC) with jurisdiction over the laboratory.
“Medicare enrollment represents a critical step in our commercialization strategy,” said Russ Havranek, EVP Corporate and Commercial Strategy. “It enables access to approximately half of the U.S. Medicare population through Traditional Medicare, subject to coverage determinations, while establishing a clear pathway to expand into Medicare Advantage populations over time. Combined with our existing ~81 million commercial covered lives, this milestone strengthens our pathway to broader patient access, adoption, and revenue growth.”
Strategic and Commercial Impact
Expanded Billing of Traditional Medicare: Enables billing for testing furnished to Medicare Fee-For-Service beneficiaries, subject to coverage determination by our local Medicare Administrative Contractor (MAC)
Pathway to Medicare Advantage: Positions CNSide Diagnostics to pursue coverage with Medicare Advantage plans, including those administered by United Healthcare, Humana, Highmark, Blue Shield of California, and other national and regional payers
Accelerates Coverage and Pricing Efforts: Enables active engagement with MACs to pursue local coverage determinations (LCDs) and supports CMS pricing determinations under the Clinical Laboratory Fee Schedule (CLFS)
Medicaid Momentum: Provides essential credentialing for state-by-state Medicaid enrollmentNext Steps: Reimbursement Momentum
With Medicare enrollment secured, CNSide Diagnostics is focused on the following near-term milestones:
Medicare Coverage Pathway — Engagement with MACs to secure formal coverage determinations
CLFS Pricing — Establishment of a payment rate for the new CPT code 0640U (CNSide CSF TCE Test), effective for billing July 1, 2026, via crosswalk or gapfill methodology
Further Commercial Expansion — Continued execution of national and regional payer contracts toward the 2026 goal of 150 million+ covered livesPositioning CNSide Diagnostics for Scaled Adoption
The CNSide® CSF Assay Platform is a novel diagnostic tool that detects and characterizes tumor cells and circulating tumor DNA in cerebrospinal fluid. It enables earlier and more accurate diagnosis, disease monitoring, and treatment decision-making for patients with leptomeningeal metastases — a devastating complication of CNS cancers where conventional methods like MRI and cytology frequently fall short.
With Medicare enrollment now complete, CNSide Diagnostics is executing a focused commercialization strategy to drive broad clinical adoption:
Payer Coverage Expansion: Building on the current 81 million commercial covered lives to further broaden access through additional national and regional payer contracts
Clinical Utility & Health Economics: Generating robust real-world data to demonstrate improved patient outcomes and cost-effectiveness
Key Account Engagement: Deepening relationships with leading academic medical centers and community oncology networks
Reimbursement Optimization: Refining coding, billing, and collections processes to maximize efficiency and revenue captureAbout CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. based in Houston, Texas that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential market for the CNSide® CSF Assay, the timing as to when the CNSide® CSF Assay will be commercially launched and expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide® CSF Assay, the development, utility and acceptance of the CNSide® CSF Assay, and expectations as to the Company’s future performance, including development and commercialization of the Company’s product candidates.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Secures Blue Shield of California Coverage for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer
Expands access by 6 million covered lives, advancing commercial momentum for CNSide® in metastatic CNS cancersHOUSTON, April 28, 2026 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), announced today a new payer coverage agreement with Blue Shield of California, effective April 2026, providing reimbursement for its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) assay for patients with metastatic central nervous system cancers. Blue Shield of California joins a growing list of national and regional payers, including United Healthcare, Humana, and Highmark, that provide coverage for CNSide.
The addition of Blue Shield of California expands CNSide’s total covered lives from approximately 75 million to 81 million, representing continued progress toward the Company’s 2026 objective of 150 million covered lives, while expanding patient access across the U.S. The agreement is expected to further accelerate adoption of CNSide across oncology centers by reducing reimbursement barriers.
“This agreement with Blue Shield of California represents another important step in expanding payer coverage and access to CNSide for patients with leptomeningeal metastases,” said Russ Havranek, EVP Corporate and Commercial Strategy at Plus Therapeutics. “We continue to execute on our strategy to broaden reimbursement, support physician adoption, and improve outcomes for patients with difficult-to-diagnose CNS cancers.”
The CNSide® CSF Assay Platform enables earlier, and more accurate detection and monitoring of leptomeningeal metastases compared to conventional CSF cytology, supporting rapid diagnosis, treatment monitoring, and treatment guidance. The superior clinical utility of CNSide® over standard of care has been demonstrated in nine peer-reviewed publications, the FORESEE clinical trial, and demonstrated in real-world practice. Earlier detection enabled by CNSide has been shown in health economic analyses to reduce overall leptomeningeal metastases-related healthcare costs by ~40%, driven by earlier detection and treatment optimization.
Since its commercial launch, more than 11,000 CNSide tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases.
This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
About Blue Shield of California
Blue Shield of California strives to create a healthcare system worthy of its family and friends that is sustainably affordable. The health plan is a taxpaying, nonprofit, independent member of the Blue Shield Association with 6 million members, over 6,500 employees and more than $27 billion in annual revenue. Founded in 1939 in San Francisco and now headquartered in Oakland, Blue Shield of California and its affiliates provide health, dental, vision, Medicaid and Medicare healthcare service plans in California. The company has contributed more than $60 million to the Blue Shield of California Foundation in the last three years to have an impact on California communities. For more news about Blue Shield of California, please visit https://news.blueshieldca.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential market for the CNSide CSF Assay, the timing in which the CNSide CSF Assay is commercially launched and commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Initiates Manufacturing Activities with SpectronRx Under a Master Services Agreement to Support GMP Pivotal Trial Readiness for REYOBIQ™
HOUSTON, April 23, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announced today the initiation of manufacturing activities and technology transfer with SpectronRx under a previously executed Master Services Agreement (MSA), in support of late-stage clinical manufacturing of Rhenium-186 and REYOBIQ. With SpectronRx serving as a second GMP manufacturing site alongside Radiomedix, and Rhenium-186 isotope supplied through Telix Pharmaceuticals, Plus strengthens the reliability of its multi-partner supply chain infrastructure.
The MSA includes the technology transfer of the REYOBIQ manufacturing process, Rhenium-186 isotope processing, analytical methods, as well as technical and regulatory expertise supporting future commercial scale production. The SpectronRx’s facility in Indiana will provide on-demand manufacturing capabilities for both Rhenium-186 isotope production and REYOBIQ drug manufacturing within the same facility, improving coordination across the radiopharmaceutical production process and simplifying logistics.
“We are focused on advancing our REYOBIQ development, including progress towards our 2026 target milestone to complete manufacturing scale-up for REYOBIQ late-stage clinical supply needs,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “As we enter late-stage development of REYOBIQ, our partnership with SpectronRx bolsters our manufacturing readiness and required expansion of our production capacity. We are closely aligned with SpectronRx for best-in-class production of REYOBIQ to serve the needs of the clinical community and drive growth in our radiotherapeutic business over time.”
“Radiopharmaceutical development increasingly depends on infrastructure that can reliably scale alongside clinical and commercial demand,” said John Zehner, SpectronRx Chief Executive Officer. “Our integrated platform, spanning isotope processing, GMP manufacturing, and regulatory expertise, is purpose-built to support partners like Plus Therapeutics as they advance late-stage programs such as REYOBIQ. We are proud to play a role in strengthening a multi-partner supply chain designed to deliver consistent, high-quality product to patients.”
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
About SpectronRx
SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer specializing in Radiopharmaceutical Contract Development (CDMO), Manufacturing (CMO) and Isotope Production. The company supports all stages of development, from early conjugations through scale-up and commercial distribution and has the capacity to run clinical trials.
With a team of experienced radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms and more than 400,000 square feet of production space, SpectronRx supplies radiopharmaceuticals to 6 continents. The company has been EMA and FDA inspected and can produce or procure any currently used radioisotope. For more information, visit https://SpectronRx.com or follow the company on LinkedIn.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company's ability to successfully raise sufficient capital on reasonable terms or at all; available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends; our ability to complete our pre-clinical or clinical studies; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
2月前
NEWS -- Plus Therapeutics Reports Granting of Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
HOUSTON, April 22, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces that it has granted inducement awards to Eric J Daniels, M.D., its new Chief Development Officer who joined the Company on April 20, 2026.
The awards were granted on April 20, 2026 under the Company’s 2015 New Employee Incentive Plan, as amended, which provides for the granting of equity awards to new employees as an inducement to join the Company. The inducement awards consist of options to purchase 20,000 shares of the Company common stock and 20,000 restricted stock units (“RSUs”).
The options have a 10-year term and an exercise price equal to $7.30, the fair market value of the Company’s common stock on the date of grant. The options vest over a four-year period, with 25% of the shares subject to the options vesting on the first anniversary of the vesting commencement date of April 20, 2026, and 1/36th vesting on each monthly anniversary thereafter, subject to Dr. Daniels’ continued service with the Company through each applicable vesting date.
Each RSU represents a contingent right to receive one share of the Company’s common stock and there is no exercise price associated with the RSUs granted thereunder. The RSUs vest over a three-year period, with 1/3 vesting on the first of the quarter immediately following the first anniversary of the grant date, and the remaining RSUs vesting ratably over the next 8 quarters, subject to Dr. Daniels’ continued service with the Company through each applicable vesting date.
The awards were approved by the Compensation Committee of the Company’s board of directors, as required by Nasdaq Rule 5635(c)(4), and were granted as an inducement material to Dr. Daniels entering into employment with the Company in accordance with Nasdaq Rule 5635(c)(4).
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Appoints Randy H. Goodman, PhD, MHA, as Vice President of Value Strategy & HEOR to Advance Market Access and Commercial Execution
Health economics and reimbursement expert brings over two decades of experience in payer strategy, value-based pricing, and health policy supporting CNSide adoption and long-term commercialization strategy for REYOBIQ™
HOUSTON, April 15, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announces the appointment of Randy H. Goodman, Ph.D., M.H.A., as Vice President, Value Strategy & Health Economics and Outcomes Research (HEOR), effective April 13th, 2026.
Dr. Goodman is a highly experienced health economics and market access leader with more than 20 years of experience spanning global pricing and reimbursement strategy, real-world evidence generation, and value-based healthcare modeling across the biotechnology, pharmaceutical, diagnostics, and medical device sectors. He has led the development of payer engagement strategies, health technology assessment (HTA) dossiers, and value frameworks supporting product launches and commercialization for leading healthcare organizations.
“Randy brings a rare combination of deep HEOR expertise, payer strategy experience, and health policy insight that will be critical as we continue to expand access and adoption of CNSide and advance our therapeutic pipeline,” said Marc Hedrick, M.D., MBA, Plus Therapeutics President and Chief Executive Officer. “His leadership will strengthen our ability to clearly demonstrate the clinical and economic value of our technologies to payers, providers, and policymakers.”
Dr. Goodman has advised leading global healthcare organizations, including Pfizer, Gilead Sciences, and Moderna, and has worked closely with government agencies such as the Centers for Medicare & Medicaid Services on value-based pricing and reimbursement frameworks. He has also served as a healthcare policy advisor to the White House on multiple health reform initiatives, contributing to the development of reimbursement and access frameworks at both the federal and state levels.
In his new role, Dr. Goodman will lead Plus’ value strategy, HEOR, and market access initiatives, with a focus on supporting the continued commercial expansion of CNSide Diagnostics and establishing the evidence and reimbursement foundation for REYOBIQ and the Company’s broader CNS oncology pipeline.
“Demonstrating clinical and economic value is increasingly critical to successful adoption of medical innovation,” said Dr. Goodman. “CNSide and REYOBIQ represent highly differentiated technologies, and I look forward to helping ensure that their value is clearly articulated and recognized across the healthcare system.”
Dr. Goodman holds a Ph.D. and Master of Healthcare Administration from the Harvard T.H. Chan School of Public Health and a Bachelor of Arts in Medical Communications from North Texas State University.
Inducement Grant
On April 13, 2026, as an inducement of Dr. Goodman to join the Company, Dr. Goodman was granted equity consisting of a total of 9,000 shares of the Company’s common stock under the Company’s 2015 New Employee Incentive Plan, as amended, which provides for the granting of equity awards to new employees as an inducement to join the Company. The inducement awards consist of options to purchase 4,500 shares of Company common stock and 4,500 restricted stock units (“RSUs”).
The options have a 10-year term and an exercise price equal to $5.41, the fair market value of the Company’s common stock on the date of grant. The options vest over a four-year period, with 25% of the shares subject to the options vesting on the first anniversary of the vesting commencement date of April 13, 2026, and 1/36th vesting on each monthly anniversary thereafter, subject to the employee’s continued service with the Company through each applicable vesting date.
Each RSU represents a contingent right to receive one share of the Company’s common stock and there is no exercise price associated with the RSUs granted thereunder. The RSUs vest over a three-year period, with 1/3 vesting on the first of the quarter following the first anniversary of the grant date, and the remaining RSUs vesting ratably over the next 8 quarters, subject to the employee’s continued service with the Company through each applicable vesting date.
The awards were approved by the compensation committee of the Company’s board of directors, as required by Nasdaq Rule 5635(c)(4), and were granted as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Rule 5635(c)(4).
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Appoints Eric J. Daniels, M.D., MBA, as Chief Development Officer to Advance Clinical Pipeline
Seasoned biotech executive brings deep experience across clinical development, regulatory strategy, and corporate operations, strengthening execution capabilities as Plus advances REYOBIQ™ and CNS-focused pipeline
HOUSTON, April 09, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced the appointment of Eric J. Daniels, M.D., MBA, as Chief Development Officer, effective April 20, 2026.
Dr. Daniels is a seasoned biotechnology executive with more than two decades of experience spanning clinical development, regulatory strategy, corporate operations, and business development. He most recently served as Chief Development Officer at Kiora Pharmaceuticals , where he oversaw the company’s full development portfolio, including clinical, preclinical, and CMC activities, and worked closely with executive leadership and Kiora’s board of directors to define and execute development strategy.
“Eric is a highly accomplished development leader with a proven ability to translate scientific innovation into clinically and commercially viable programs,” said Marc Hedrick, M.D., MBA, Plus Therapeutics President and Chief Executive Officer. “His experience building and advancing therapeutic pipelines, combined with his strategic and operational expertise, will be instrumental as we accelerate the advancement of REYOBIQ and our broader CNS oncology portfolio.”
Dr. Daniels brings a unique combination of development and entrepreneurial experience, having co-founded Bayon Therapeutics and previously served as Chief Executive Officer of OccuRx, where he led all aspects of corporate strategy, clinical development, and operations. Earlier in his career, he held senior leadership roles at Cytori Therapeutics, Inc., where he contributed to global clinical development programs, strategic partnerships, and international commercialization initiatives.
“Plus Therapeutics is at a pivotal time in its promising development trajectory,” said Dr. Daniels. “The Company’s targeted radiotherapeutic platform is a highly differentiated approach to both targeting and treating CNS cancers, and I look forward to working with the team to advance REYOBIQ and deliver meaningful outcomes for patients and physicians.”
Dr. Daniels received his M.D. from the David Geffen School of Medicine at University of California Los Angeles and his MBA from the UCLA Anderson School of Management. He holds a Bachelor of Science in Molecular and Cell Biology from the University of California, Berkeley.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to REYOBIQ™ in Pediatric Malignant Gliomas
HOUSTON, April 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to REYOBIQ™ (rhenium Re186 obisbemeda) for the treatment of pediatric malignant gliomas.
Pediatric malignant gliomas are rare, aggressive brain tumors with limited treatment options and poor outcomes, where current standards of care—including surgery and radiation—often fail to prevent recurrence.
Notably, the FDA granted orphan designation for malignant glioma more broadly than originally requested, encompassing pediatric ependymoma.
“Receiving orphan drug designation for REYOBIQ in pediatric malignant gliomas, including the broader scope for progressive pediatric ependymoma, is an important milestone and further validates our approach to delivering targeted radiotherapy directly to CNS tumors,” said Marc Hedrick, M.D., President and Chief Executive Officer of Plus Therapeutics. “We believe REYOBIQ’s ability to deliver high-dose radiation precisely to tumor sites while minimizing exposure to healthy brain tissue has the potential to meaningfully improve outcomes in this underserved patient population. This orphan designation reinforces the potential applicability of REYOBIQ across a wider range of CNS tumor indications and our continued advancement of REYOBIQ across multiple CNS cancer indications.”
Orphan Drug Designation is granted by the FDA to investigational therapies intended to treat rare diseases affecting fewer than 200,000 people in the United States. The designation provides several potential benefits, including seven years of market exclusivity upon approval, tax credits for qualified clinical trial expenses, and exemptions from certain regulatory fees.
The ODD for pediatric malignant gliomas builds on recent regulatory and clinical progress for REYOBIQ, including completion of a Type B meeting with the FDA supporting development plans in leptomeningeal metastases (LM), encouraging clinical data from the ReSPECT-LM trial, and ongoing advancement of Phase 1 and Phase 2 studies. In addition, the Company has received FDA clearance of its Investigational New Drug (IND) application to evaluate REYOBIQ in pediatric patients with high-grade glioma and ependymoma.
About Pediatric Malignant Gliomas
Pediatric malignant gliomas are high-grade brain tumors that form from glial cells in the central nervous system that tend to grow quickly in children. Pediatric high grade gliomas (HGG), including ependymoma, are rare (approximately 3.3 cases per 100,000 persons) but aggressive brain tumors with limited treatment options and poor prognosis, particularly in recurrent settings. Standard treatments, including surgical resection and external beam radiation therapy, often fail to prevent recurrence, with 5-year survival rates as low as 22% for HGG, depending on tumor grade and resection extent.
About Leptomeningeal Metastases
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: statements relating to the significance of the FDA ODD grant to the advancement of REYOBIQ as potential treatment of patients who suffer from for pediatric malignant gliomas; statements regarding the potential promise of REYOBIQ, including the next steps in developing the Company’s product candidates; and, the Company’s clinical trials, including statements regarding the Company’s engagement with the FDA with respect to the possibility of defining a pivotal trial strategy for certain of the Company’s clinical trials. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Receives AMA PLA Code for CNSide® CSF Tumor Cell Enumeration Test, Advancing Reimbursement and U.S. Commercial Adoption
New dedicated billing code facilitates payer reimbursement, supports clinician adoptions, and enables national utilization tracking
HOUSTON, April 07, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces that the American Medical Association (AMA) has approved a new, Proprietary Laboratory Analyses (PLA) Current Procedural Terminology (CPT) code for its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) test.
The dedicated billing code, 0640U, effective July 1, 2026, establishes a unique reimbursement identifier for the CNSide CSF TCE test, supporting payer claims processing and facilitating broader clinical adoptions as the Company continues the U.S. commercial launch of its CNS metastases diagnostic platform.
“Securing a dedicated PLA code for CNSide is an important milestone supporting the commercial launch of our CNSide Diagnostics business,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “This coding milestone simplifies the reimbursement pathway for the CNSide CSF Tumor Cell Enumeration test and supports broader clinical adoption by oncologists and neurologists managing patients with leptomeningeal metastases. As awareness and payer coverage expand, we believe CNSide has the potential to become an important tool in the management of metastatic CNS cancers while contributing meaningfully to our revenue growth. Our diagnostics business continues to scale alongside our therapeutic pipeline, and we remain focused on building CNSide into a sustainable commercial franchise.”
Key implications of the newly assigned PLA code 0640U
Supports payer reimbursement processes. Provides a dedicated billing code specific to the CNSide CSF Tumor Cell Enumeration test, enabling standardized claims submission and facilitating payer coverage determinations.
Facilitates clinician adoption. Simplifies ordering and billing processes for clinicians and cancer centers evaluating patients with suspected leptomeningeal metastases.
Enables national utilization tracking. PLA coding allows tracking of test utilization through claims data, supporting real-world evidence generation related to clinical outcomes and health economics.
Supports ongoing U.S. commercial launch. The coding milestone strengthens the reimbursement infrastructure supporting the Company’s ongoing U.S. launch of CNSide CSF test.About PLA Codes
Proprietary Laboratory Analyses (PLA) codes are issued by the American Medical Association to uniquely identify specific laboratory tests performed by a single laboratory or manufacturer. A dedicated PLA code allows healthcare providers to bill insurers using a standardized code that reflects the specific diagnostic test performed, facilitating claims processing and enabling tracking of test utilization across the healthcare system.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative detection and molecular characterization of tumor cells in cerebrospinal fluid, providing actionable diagnostic information to physicians managing patients with leptomeningeal metastases, a serious and often difficult-to-diagnose complication of advanced cancer. Leptomeningeal metastases occur when cancer spreads to the membranes surround the brain and spinal cord and are associated with significant morbidity and limited diagnostic tools, highlighting the need for more sensitive diagnostic approaches.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: expectations regarding the completion of the proposed offering; the Company's ability to successfully raise sufficient capital on reasonable terms or at all; available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends; our ability to complete our pre-clinical or clinical studies; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2025, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Reports Granting of Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
HOUSTON, March 31, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced that it has granted inducement awards to two new employees who recently joined the Company.
The awards were granted on March 26, 2026 under the Company’s 2015 New Employee Incentive Plan, as amended, which provides for the granting of equity awards to new employees as an inducement to join the Company. The inducement awards consist in the aggregate of options to purchase 300,000 shares of Company common stock and 300,000 restricted stock units (“RSUs”).
The options have a 10-year term and an exercise price equal to $0.243, the fair market value of the Company’s common stock on the date of grant. The options vest over a four-year period, with 25% of the shares subject to the options vesting on the first anniversary of the vesting commencement date of March 26, 2026, and 1/36th vesting on each monthly anniversary thereafter, subject to the employee’s continued service with the Company through each applicable vesting date.
Each RSU represents a contingent right to receive one share of the Company’s common stock and there is no exercise price associated with the RSUs granted thereunder. The RSUs vest over a three-year period, with 1/3 vesting on the first anniversary of the grant date, and the remaining RSUs vesting ratably over the next 8 quarters, subject to the employee’s continued service with the Company through each applicable vesting date.
The awards were approved by the Compensation Committee of the Company’s board of directors, as required by Nasdaq Rule 5635(c)(4), and were granted as an inducement material to the new employees entering into employment with the Company in accordance with Nasdaq Rule 5635(c)(4).
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as the CNSide® Tumor Cell Enumeration assay, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
3月前
NEWS -- Plus Therapeutics Announces Reverse Stock Split
HOUSTON, March 31, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-25. The reverse stock split will become effective at 12:01 a.m. Eastern Time on April 2, 2026, and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on April 2, 2026 under the Company’s existing trading symbol, “PSTV.” At such time, the Company’s common stock will also commence trading with a new CUSIP number, 72941H806.
The reverse stock split is being implemented to increase the per share trading price of the Company’s common stock for the purpose of ensuring a share price high enough to comply with the minimum $1.00 bid price requirement for continued listing on The Nasdaq Capital Market.
At the effective time of the reverse stock split, every twenty-five (25) shares of Plus Therapeutics common stock issued and outstanding will be combined into one (1) share of common stock issued and outstanding, with no change to the par value of $0.001 per share. This will reduce the Company’s outstanding common stock from approximately 171,550,698 shares to approximately 6,862,027 shares. No fractional shares of common stock will be issued as a result of the reverse stock split and instead holders of Plus common stock will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. The shares underlying the Company’s outstanding equity awards and warrants will also be adjusted accordingly. The reverse stock split affects all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s common stock, except for adjustments that may result from the treatment of fractional shares.
The Company has retained its transfer agent, Broadridge Financial Services, Inc. (“Broadridge”), to act as its exchange agent for the reverse stock split. Stockholders with shares held in certificate form will receive from Broadridge instructions regarding the exchange of their certificates. Stockholders that hold shares in book-entry form or hold their shares in brokerage accounts are not required to take any action and will see the impact of the reverse stock split reflected in their accounts, subject to brokers’ particular processes. Beneficial holders of Plus Therapeutics common stock are encouraged to contact their bank, broker, custodian or other nominee with questions regarding procedures for processing the reverse stock split.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the implementation and proposed timing of the reverse stock split, the commencement of trading of the Company’s post-split common stock, the impact of the reverse stock split on the Company’s securityholders, including any adjustments that may result from the treatment of fractional shares, the potential for the Company to regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be issued and outstanding following the reverse stock split.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks and uncertainties related to the reverse stock split having the desired effect, the Company’s ability to regain compliance with Nasdaq’s listing requirements, the potential de-listing of the Company’s securities on Nasdaq, and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
4月前
NEWS -- Plus Therapeutics Announces New Category III CPT Code for Convection-Enhanced Delivery Used with REYOBIQ™
Unlocks market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer by enabling adoption and utilization tracking
HOUSTON, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ: PSTV) (the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announced the American Medical Association’s (AMA) CPT® (Current Procedural Terminology) Editorial Panel approved a new Category III CPT code to track utilization of convection-enhanced delivery (CED) used in the administration of REYOBIQ for recurrent glioblastoma (rGBM) and pediatric brain cancer (PBC).
“The approved Category III CPT code for convection-enhanced delivery of REYOBIQ in recurrent glioblastoma and pediatric brain cancer – the most prevalent malignant tumors of the brain and central nervous system – marks a major step in bringing market access for an innovative treatment targeting an aggressive and deadly disease resistant to conventional treatments. This milestone reflects the culmination of years of REYOBIQ development and represents an important advancement in our path to commercialization and reimbursement. With standardized REYOBIQ clinical use now tracked under the new CPT code, its utilization can be evaluated as a bridge to approval and broad adoption,” said Marc Hedrick MD, Plus Therapeutics President and CEO. “We remain focused on making strong clinical progress with REYOBIQ. We are on track to complete enrollment in our Phase 2 recurrent glioblastoma trial in 2026, followed by an end-of-Phase 2 meeting to align on pivotal trial design. In addition, we continue to expect first patient enrollment in our Phase 1 pediatric brain cancer trial in 2026.”
Category III CPT codes are established by the AMA’s CPT® Editorial Panel to describe emerging medical technologies and procedures and to support utilization tracking and data collection that may inform future coverage, reimbursement, and transition to permanent Category I CPT codes. The approved Category III CPT code for CED procedures is:
X566T, Stereotactic placement of infusion catheter(s), brain, for delivery of therapeutic agent(s), including computerized stereotactic planning and burr hole(s).The new Category III CPT code will be published on July 1, 2026 and will become effective for reporting on January 1, 2027.
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
Forward Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: expectations regarding the completion of the proposed offering; the Company's ability to successfully raise sufficient capital on reasonable terms or at all; available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends; our ability to complete our pre-clinical or clinical studies; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
5月前
NEWS -- Plus Therapeutics Announces Pricing of Upsized $15 Million Public Offering
HOUSTON, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ: PSTV) (the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, today announces the pricing of its underwritten public offering of 39,473,684 units, with each unit consisting of one share of common stock and one warrant (the “Warrants”). Each unit is being sold to the public at a price of $0.38 per unit. The gross proceeds to the Company from this offering are expected to be approximately $15 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Each Warrant will be immediately exercisable, will entitle the holder to purchase one share of common stock at an exercise price of $0.38 per share and will expire five years from the date of issuance. The Company has granted the underwriter a 30-day option to purchase up to an additional 5,921,052 shares of common stock and/or warrants to purchase up to an additional 5,921,052 shares of common stock, or any combination thereof, solely to cover over-allotments, if any.
The Company intends to use the proceeds for working capital and general corporate purposes.
The offering is expected to close on January 15, 2026, subject to satisfaction of customary closing conditions.
Lake Street Capital Markets, LLC is acting as the sole underwriter for the offering.
A registration statement on Form S-1, as amended (File No. 333-292637) relating to the securities was filed with the Securities and Exchange Commission (“SEC”) on January 9, 2026 and was declared effective on January 13, 2026, and a related registration statement was filed with the SEC on January 13, 2026 pursuant to Rule 462(b) under the Securities Act of 1933, as amended, and became automatically effective upon filing (together, the “Registration Statement”). This offering is being made only by means of a preliminary prospectus forming a part of the Registration Statement and a final prospectus. The Registration Statement and the preliminary prospectus relating to the offering are available for free on the SEC’s website at www.sec.gov. Copies of the final prospectus, when available, may be obtained from Lake Street Capital Markets, LLC, 121 S 8th St Suite 1000, Minneapolis, MN 55402. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
Forward Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "anticipate" "intend," "believe," "estimate," "will," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: expectations regarding the completion of the proposed offering; the Company's ability to successfully raise sufficient capital on reasonable terms or at all; available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends; our ability to complete our pre-clinical or clinical studies; and changes in local or national economic conditions. This list of risks, uncertainties, and other factors is not complete. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
6月前
NEWS -- Plus Therapeutics Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™ for Leptomeningeal Metastases
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late 2026
HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announces the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company’s goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM.
Highlights of FDA responses to the Company's key enquiries:
Accelerated approval – FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications.
Primary and key endpoints – FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint.
Trial design and comparator group - FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol.
Treated populations - FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial.“Our recent FDA end of phase meeting was constructive, and we hope will help us speed up our clinical development timelines and facilitate faster submission of an application for the approval of REYOBIQ for patients with LM,” said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. “As there are no approved drugs for LM, this discussion with the FDA early in clinical development will allow us to make relevant amendments to our current trial protocol and to begin meaningful planning for an anticipated pivotal trial. Furthermore, based in part on this meeting, we will plan to accelerate REYOBIQ commercial manufacturing and scale-up activities to meet an expedited timeline.”
About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding the potential study design for REYOBIQ in LM and the Company’s plans to plan to accelerate REYOBIQ commercial manufacturing, among others. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. The Company discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions it might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
7月前
NEWS -- Plus Therapeutics Expands CNSide Assay Platform to State of California
CNSide Diagnostics now licensed in 48 U.S. States covering over 90% of the U.S. population
HOUSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces that it has been granted lab licenses to provide the CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) laboratory developed test (LDT) in California, Rhode Island and Maryland.
“CNSide Diagnostics is now licensed to provide our proprietary testing service in 48 of 50 U.S. states and obtaining state licensure is a key enabler of our plan to bring the benefits of CNSide CSF testing to the broadest possible set of patients with CNS cancers,” said Russ Bradley, CNSide Diagnostics, LLC President and General Manager. “We remain focused on executing on U.S. market access and launch strategy and look forward to continued expansion of coverage across payors and states.”
The CNSide® CSF Assay Platform supports rapid diagnoses, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases. The superior clinical utility of CNSide® over standard of care has been shown in 9 peer-reviewed publications, the FORESEE clinical trial, and has been validated in the market through real-world use.
More than 11,000 CNSide® tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases.
This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.
CNSide Diagnostics, LLC performs the tests in its CLIA certified facility in Houston, TX.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding the market for CNSide and the potential launch and test coverage expansion, including plans for additional payor agreements. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. The Company discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions it might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
7月前
NEWS -- Plus Therapeutics Announces Expansion of CNSide Team and Issuance of Inducement Grants
HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced two new hires to its team for CNSide Diagnostics, LLC, its wholly-owned subsidiary.
“We are strategically building the team to bolster our capabilities as we scale up our laboratory operations to address the largely untapped $6billion+ U.S. addressable market for CNSide cerebrospinal fluid assay for metastatic CNS cancers, all the while maintaining the highest quality standards,” said Russ Bradley, CNSide Diagnostics, LLC President and General Manager. “We continue our steady progress toward national launch and test coverage expansion, with plans for additional payor agreements to the previously announced agreements with UnitedHealthcare and Humana.”
Two team members joining the CNSide Diagnostics team are:
Mr. Prem Gurnani joins as Senior Director of Lab Operations and Systems Implementation, with over sixteen years of experience in diagnostics, clinical operations, regulatory compliance, and technology driven process improvement across high growth healthcare organizations and laboratory environments, with a strong record supporting operational scale up
Ms. Elaine Luckey joins as Director of Quality and Regulatory affairs, with over twenty years of experience in quality and regulatory affairs in CLIA/CAP laboratory environments, with track record in start-ups, quality system implementation and regulatory compliance.In connection with these two new hires, on December 4, 2025, the Company granted stock options and restricted stock units (“RSUs”) to Mr. Gurnani and Ms. Luckey under its 2015 New Employee Incentive Plan, which is intended to meet the requirements of a plan providing for inducement grants under Nasdaq Listing Rule 5635(c)(4). The awards were approved by the Company’s Compensation Committee and made as a material inducement to each employee's entry into employment with the Company.
The approved option awards for each of Mr. Gurnani and Ms. Luckey consist of options to purchase up to 33,750 shares of the common stock of the Company. The exercise price of the options is equal to the closing price of the Company’s common stock on December 4, 2025, the grant date. The approved option awards to Mr. Gurnani and Ms. Luckey are scheduled to vest over four years, with one-fourth of the options vesting on the first anniversary of the grant date with the remaining options vesting thereafter in 36 equal monthly installments. The vesting of the options is also subject to certain requirements, including each employee’s continued service as an employee of the Company through the applicable vesting dates.
In addition, the Company issued Mr. Gurnani and Ms. Luckey 11,250 RSUs each. The RSUs are scheduled to vest over three years, with one-third of the RSUs vesting on January 1, 2027 (approximately one-year from the first anniversary of the grant date) with the remaining RSUs vesting quarterly thereafter in eight (8) equal installments. The vesting of the RSUs is also subject to certain requirements, including continued service as an employee of the Company through the applicable vesting dates.
The Company believes that these equity grants create a strong alignment of interests between Mr. Gurnani, Ms. Luckey, and the Company’s shareholders. The equity awards were granted outside of the Company’s 2020 Incentive Plan but generally have terms and conditions consistent with those set forth in that plan. The Company has filed a Form S-8 covering these equity awards.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding the market for CNSide and the potential launch and test coverage expansion, including plans for additional payor agreements. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. The Company discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions it might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
7月前
NEWS -- Plus Therapeutics Highlights Three REYOBIQ™ Clinical Data Presentations at 2025 WFNOS/SNO Annual Meeting
Cohort 1 data from multiple dose ReSPECT- Leptomeningeal Metastases (LM) trial showed no dosage limiting toxicity
ReSPECT-Glioblastoma (GBM) trial of REYOBIQ as a novel therapeutic for recurrent GBM demonstrated promising safety and efficacy signal, supporting continued Phase 2 enrollment and investigation
MRI combined with SPECT imaging biomarkers effectively evaluate overall survival response with REYOBIQ in recurrent GBM treatment and help guide personalized patient planningHOUSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces three positive clinical data update presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting, November 19-23, 2025 in Honolulu, Hawaii. The World Federation of Neuro-Oncology Societies (WFNOS) and Society for Neuro-Oncology (SNO) advance research, education, and clinical care for patients with tumors of the central nervous system.
“Real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers continues to show a promising safety profile and signs of efficacy,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “This expanding clinical data set around REYOBIQ coupled with substantial progress bringing our CNSide diagnostic portfolio to market provides our team at Plus with growing confidence that we can achieve our goal of materially improving survival rates for patients with CNS cancers.”
KEY HIGHLIGHTS:
Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data
Overview:
Completed ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed
ReSPECT-LM open label, multidose Phase 1/2 trial initiated to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response using CNSide CSF tumor cell enumeration testResponse:
Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals
Three patients enrolled as of data cutoff: one patient has received all doses without dose limiting toxicityNext Steps:
Phase 1b/2a dose optimization trial is enrolling with the ultimate goal of improving outcomes for LM patientsPhase 1/2 ReSPECT-GBM Trial of Rhenium (186Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2
Overview:
Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. Dose 22.3 mCi was selected as the recommended Phase 2 dose due to its favorable safety profile
Ongoing Phase 2 study has enrolled 24 of planned 34 patients as of data cutoff; study continues to evaluate safety and efficacy at the Phase 2 recommended doseSafety:
Across all patients treated in both Phase 1 and 2, most treatment-related adverse events were Grade 1 or 2, including lymphopenia (7.9%), cognitive disorder (7.0%), and headache (7.0%), with no treatment-related deaths or study discontinuations due to serious adverse reactions (SARs)Response:
Efficacy data from Phase 1 cohorts 1 to 6 showed a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving
Paulness
7月前
NEWS -- Plus Therapeutics to Present ReSPECT Phase 1 Dose Escalation Study Results for Leptomeningeal Metastases at the 2025 San Antonio Breast Cancer Symposium
Study findings to be featured in a poster spotlight presentation
HOUSTON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), being held on December 9-12, 2025, in San Antonio, TX.
Poster Spotlight Presentation:
Title: Rhenium (186Re) obisbemeda (rhenium nanoliposome, 186RNL) for the treatment of leptomeningeal metastases (LM): Phase 1 dose escalation study results
Presenter: Andrew Brenner, M.D., Ph.D., Professor and Kolitz / Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, Science Center at San Antonio
Presentation Date/Time: Friday, December 12, 2025, 7:39am to 7:42 am CST
Session Date/Time: Friday, December 12, 2025, 7:00am to 8:30 am CST
Location: Hemisfair 3, Henry B. Gonzalez Convention CenterAbout LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.
About CNSide Diagnostic, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; risks related to a halt in trading or delisting of the Company’s common stock on Nasdaq; Medicare and private payors may not provide coverage and reimbursement or may breach, rescind or modify their contracts or reimbursement policies or delay payments; the risk that our products and services may not perform as expected; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at https://www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
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