Paulness
16 hours ago
NEWS -- Plus Therapeutics Announces Two CNSide Presentations at the Upcoming SNO/ASCO CNS Metastases Conference
The Joint Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO) focus on the rapidly evolving area of central nervous system metastases
Presentations will highlight the clinical utility of the company’s CNSide Cerebrospinal Fluid (CSF) Assay Platform for patients at risk for central nervous system metastasesHOUSTON, July 10, 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, today announced that its wholly-owned subsidiary, CNSide Diagnostics, LLC (“CNSide”) will be showcasing two presentations at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD.
The CNSide data highlights its ability to quantify tumor cells and deliver actionable insights,” said Michael Rosol, Ph.D., Plus Therapeutics’ Chief Development Officer. “The diagnostic assay is an exciting advancement for enhancing CNS metastases management and driving therapies like REYOBIQ™ in our ReSPECT-LM dose optimization trial."
Presentations:
Title: CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker Assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (BIOM-04), (FORESEE Study, NCT05414123)
Presenter: Priya Kumthekar, M.D.
Date/Time: Thursday, August 14, 2025, 7:15 – 9:00 p.m. ET
Location: Grand Ballroom VI
Title: The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor, (BIOM-03)
Presenter: Priya Kumthekar, M.D.
Date/Time: Friday, August 15, 2025, 3:25 – 4:50 p.m. ET
Location: Grand Ballroom I-VAbout 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 and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases.
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 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.
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.
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 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 days ago
NEWS -- Plus Therapeutics Announces Initial Patients Successfully Treated in ReSPECT-LM Dose Optimization Trial for REYOBIQ™ in Leptomeningeal Metastases
Substantial clinical need expected to facilitate rapid overall trial enrollment
HOUSTON, July 08, 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, today announced the treatment of its initial patients in the Company’s ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM). The dose optimization trial builds on promising results from the Company’s completed Phase 1 single-dose escalation study, which demonstrated the feasibility of REYOBIQ for treating LM. The trial is designed in alignment with the FDA’s Project Optimus to identify the optimal dosing regimen that maximizes efficacy and safety.
“Based on the promising, recently completed Phase 1 single-dose escalation study and lack of FDA approved therapies for LM, we expect trial enrollment to proceed rapidly in accordance with the trial protocol,” said Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio. “Furthermore, assuming REYOBIQ continues its attractive safety profile, we expect that we will enroll all required patients and doses in Cohort 1 by the end of this year.”
Patients and family members interested in enrolling in the ReSPECT-LM Dose Optimization Trial can learn more here.
ReSPECT-LM Dose Optimization Trial
The study aims to optimize treatment dosing for maximum efficacy and safety, with the primary objectives of determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals in patients with LM from any primary solid tumor cancer, and to identify both the maximum tolerated dose and minimum effective dose. Previously announced details of the study, including primary, secondary, and exploratory endpoints, can be found here.
The dose optimization study builds on encouraging results from the Company’s previously announced Phase 1 trial, which showed a single dose of REYOBIQ delivered up to an average absorbed dose of >250 Gy to the cranial subarachnoid space. It also demonstrated that 5 of 7 patients achieving an over 80% reduction in LM tumor cells in the cerebrospinal fluid survived at least one year post-treatment. Additional details can be found here.
The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial.
The ReSPECT-LM dose optimization trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), the second largest public funding source for cancer research in the world.
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 Cancer Prevention & Research Institute of Texas (CPRIT)
The Cancer Prevention & Research Institute of Texas (CPRIT) is a $6 billion cancer research and prevention initiative legislated in Texas. CPRIT accepts applications and award grants for a wide variety of innovative cancer-related research and product development and for the delivery of evidence-based cancer prevention programs and services by public and private entities located in Texas. CPRIT is the largest state cancer research investment in the history of the United States and the second largest cancer research and prevention program in the world with a three-part mission, established by the Texas Legislature, to invest in the research prowess of Texas universities and research organizations; create and expand life science infrastructure across the state; and expedite innovation in research and enhance the potential of breakthroughs in prevention and cures.
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), recurrent glioblastoma (GBM), and pediatric brain cancer (PBC). 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/ or contact mailto://info@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 statements regarding the potential promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials. 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; 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 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
2 weeks ago
NEWS -- Plus Therapeutics Announces FDA Agreement to Initiate ReSPECT-LM Dose Optimization Trial for REYOBIQ™ in Leptomeningeal Metastases
Primary objective to determine optimal dosing schedule for a registrational trial
Trial builds on recommended Phase 2 dose determined in completed Phase 1 trial
Trial benefits from $17.6M award from the Cancer Prevention & Research Institute of Texas
HOUSTON, June 30, 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, today announces the initiation of the ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM). The dose optimization trial follows encouraging results from the Company’s single-dose escalation trial and is designed to evaluate multiple-dose regimens of REYOBIQ administered at defined intervals via intraventricular catheter (Ommaya reservoir).
“A safe and effective therapeutic to address the epidemic of CNS metastases and specifically leptomeningeal metastases is urgently needed,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “We expect that optimizing the dosing regimen for REYOBIQ in this trial will provide data needed to design and support a follow-on registrational trial.”
ReSPECT-LM Dose Optimization Trial Design
The study design is consistent with the FDA’s Project Optimus, and aims to optimize treatment dosing for maximum efficacy and safety. The primary objectives of the trial include determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals in patients with LM from any primary solid tumor cancer and to identify both the maximum tolerated dose and minimum effective dose.
Key additional elements of the trial design include:
Enrollment of up to 24 patients, evaluating REYOBIQ administered at the recommended Phase 2 dose or R2PD of 44.1 mCi, fractionated across three dosing intervals, with up to six patients per cohort interval:
Cohort 1: 56 days
Cohort 2: 28 days
Cohort 3a: 14 days
Cohort 3b: 14 days (6 doses)The trial will evaluate both safety, pharmacokinetics/dosimetry, and select efficacy-related endpoints such as objective response rate (ORR), neurologic progression-free survival (PFS), overall survival (OS), changes in neurologic status
Furthermore, the trial will analyze cerebrospinal fluid (CSF) tumor cell counts via Plus’ CNSide CSF assay platform, other pharmacodynamic markers, and compare these to standard CSF cytologyBecause of the anticipated pace of enrollment, the trial is being limited initially to only two prestigious and high enrolling cancer centers, both in Texas—the University of Texas Health Science Center at San Antonio (UTHSCSA) and the University of Texas Southwestern Medical Center (UTSW) but may expand to more sites if needed.
The dose optimization study builds on promising results from the Company’s single-dose escalation trial. Key highlights include:
Cohort 4 dose (44.1 mCi) was determined to be the RP2D
Pharmacodynamic and pharmacokinetic data showed that a single dose of REYOBIQ remained in the CSF for at least 7 days, and delivered up to an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5
Neuroimaging results showed a clinical benefit rate of 76%, with 5 of 17 patients (29%) achieving partial responses and 8 (47%) maintaining stable disease through Day 112
Clinical examination showed a clinical benefit rate in 87% of evaluable patients, with 13 of 15 patients showing a partial response or stable disease based on physician assessment
No dose-limiting toxicities (DLTs) were observed in the first four cohorts; one Grade 4 DLT (thrombocytopenia) occurred in each of Cohorts 5 and 6
Biologic signals of early apoptosis, innate immune activation, and increased T-cell activity by Day 28, as observed through RNA sequencing of LM cells
5 of 7 patients with over 80% reduction of LM tumor cells in CSF survived at least one year after initial treatmentThe Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial.
The ReSPECT-LM dose optimization trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), the second largest public funding source for cancer research in the world.
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 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), recurrent glioblastoma (GBM), and pediatric brain cancer (PBC). 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/ or contact mailto://info@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.
These statements include, without limitation, statements regarding the potential promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of REYOBIQ™ including through evaluations in additional patient cohorts.
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 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 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
1 Clinical benefit rate defined as complete response + partial response + stable disease
Paulness
2 weeks ago
NEWS -- Plus Therapeutics Provides Business Update on CNSide Diagnostics Subsidiary
U.S. commercial rollout of novel diagnostic platform to begin second half 2025
Underserved CNS cancer diagnostic U.S. market opportunity estimated to be in excess of $6 billion
Management to host a conference call today at 9am ET
HOUSTON, June 26, 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, will provide a business update for its wholly-owned subsidiary, CNSide Diagnostics, LLC (“CNSide”). The proprietary CNSide Cerebrospinal Fluid (CSF) Assay Platform is designed and intended for patients suspected of having central nervous system cancer metastases (CNS Mets). The first test to be commercialized, CNSide CSF Tumor Cell Enumeration (TCE), has a total addressable market estimated to be $6 billion in the U.S.
“The developer of the CNSide technology invested over $300 million in this core technology and after a year of detailed analysis and preparation by our team and key consultants, our enthusiasm regarding the unmet clinical need and the inherent value of CNSide has only grown,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “CNSide, as a laboratory-developed test widely adopted under a prior commercial program, will begin to hit the market this year under our full commercial access strategy, providing Plus with an expedited path to both revenue and corporate profitability while allowing us to continue the progress in our core CNS radiotherapeutics clinical development pipeline.”
CNSide is a Comprehensive Diagnostic Platform Addressing an Underserved Patient Population
CNS Mets are an epidemic affecting as many as 30% of adult cancer patients and affect the highly protected CNS space. Once the CNS is affected, diagnosis and treatment are difficult and as a result, approximately half of patients with CSF metastases instead receive just palliative care or hospice. The current standard of care for CNS Mets diagnosis, CSF cytology, was developed over a century ago and offers suboptimal test sensitivity leading to missed or delayed diagnosis and treatment.
By comparison, the comprehensive CNSide CSF Assay is a highly sensitive platform that diagnoses, monitors, and guides treatment, demonstrating significant advantages over the current standard of care. The superior clinical utility of CNSide has been shown in 8 peer-reviewed publications, a completed clinical trial, and has been validated in the market through real-world use. More than 11,000 CNSide tests have been performed at over 200 U.S. cancer institutions since 2020, delivering high sensitivity (92%) and specificity (95%), while influencing treatment decisions in 90% of cases. The Company believes that the CNSide CSF Assay Platform provides both clinical and economic value relative to the standard of care for CNS cancer management, with further substantial value added to the Company’s lead developmental radiotherapeutic candidate, REYOBIQ, for patients with a common form of CNS Mets, leptomeningeal metastases.
CNSide Progress Since Acquisition to Support Commercial Readiness
Since acquiring CNSide in 2024, the Company has established infrastructure to support a scalable and centralized testing laboratory in Houston, TX that will service the U.S. market. The Company has been executing on its commercial market access strategy, which includes prioritized state licensure, proprietary reimbursement codes, commercial and government payor coverage, and value-based pricing to optimize revenue. The Company anticipates introducing the CNSide platform first in Texas in the second half of 2025, followed rapidly by expansion into additional states in late 2025 and 2026. In parallel, additional expanded CNS testing capabilities are also expected to roll out over the next year.
When the CNSide CSF Assay Platform was previously commercially available, market acceptance and adoption were widespread, with several national and regional commercial payor agreements in place and the test in regular use at major cancer centers across the U.S. The Company is now in contact with the legacy payors and healthcare providers in anticipation of the planned 2025 launch, and later this year will be expanding those contacts to support a 50-state strategy. Finally, Plus has hired experienced leadership with expertise in the development and commercialization of clinical diagnostic technologies on a large scale, including its recent hire of Mr. Russ Bradley as CNSide Diagnostics, LLC President and General Manager.
“We believe CNSide is uniquely differentiated by providing physicians with superior tools for the detection, enumeration, and characterization of metastatic cancer cells in the central nervous system,” said Mr. Bradley. “This foundation is supported by prior market acceptance and rapid adoption of the CNSide technology by over 200 unique physician providers at more than 120 separate institutions when it was first previewed in 2020. As we move toward reintroducing CNSide to healthcare providers in the U.S., we anticipate strong clinical demand, as several payor reimbursement agreements were previously negotiated and in place.”
CNSide Financials and Guidance for the Remainder of 2025
“Plus Therapeutics will update investors on the commercial progress of CNSide later this year,” said Andrew Sims, Plus Therapeutics' Vice President and Chief Financial Officer. “We anticipate that while CNSide’s launch is on track for 2025, given our current forecasts the revenue contributions of the CNSide subsidiary will become meaningful to Plus Therapeutics' operations in fiscal year 2026.”
Webcast and Conference Call Details
Plus Therapeutics will host a conference call and webcast today, June 26, 2025, at 9:00 a.m. ET to discuss and provide additional details on its CNSide diagnostic business. Participants can register here any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. A live webcast of the conference call will be available here as well as on the Investor Relations section of the Company’s website at https://ir.plustherapeutics.com. The webcast will be archived on the website following the completion of the call.
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 and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases.
About Leptomeningeal Metastases (LM)
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 186re obisbemeda)
REYOBIQ™ (rhenium 186re 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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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 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. 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.
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.
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 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
Note: The Company has derived this number based on published CNS cancer incidence data, third-party projections of test utilization, and established market benchmarks.
Paulness
2 weeks ago
NEWS -- Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer
Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense
Trial will enroll children with high grade glioma and ependymoma
HOUSTON, June 25, 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, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma. The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense.
"We are very excited for the opportunity to study the novel radiotherapeutic, REYOBIQ, in difficult-to-treat pediatric brain tumors. Surgery and external beam radiation have been the mainstays of treatment for pediatric high-grade glioma and, sadly, outcomes have not improved for many decades. We believe this novel therapy that may allow higher doses of radiation while limiting the exposure to normal developing brain and delivering this agent via convection enhanced delivery (CED) directly into the tumor has the potential to make a big difference in our patients' lives and improve outcomes,” said Dr. Ashley S. Plant, M.D., Principal Investigator for the trial, attending physician in Hematology, Oncology, Neuro-oncology, and Stem Cell Transplantation at Ann & Robert H. Lurie Children's Hospital of Chicago, A.M. Khokhar Research Scholar and Associate Professor of Pediatrics at Feinberg School of Medicine Northwestern University. “I am extremely passionate about bringing this therapy into the pediatric space and hopeful about the benefits to my patients."
Phase 1/2a Trial Design Highlights:
The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose (MTD), safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years (with consideration for patients up to 25 years on a case-by-case basis).
Key elements of the trial design include:
Phase 1a/b (Dose Escalation): This phase will enroll an estimated 24 patients using a modified 3+3 dose escalation scheme to establish the MTD and recommended Phase 2 dose (RP2D). Safety assessment and alignment with the FDA will occur at defined intervals.
Phase 2a: This phase will enroll approximately 32 patients (12 with ependymoma and 20 with HGG) at the RP2D to assess efficacy.Pediatric 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. REYOBIQ’s targeted delivery via CED bypasses the blood-brain barrier, offering a novel approach to potentially improve outcomes for these patients.
“This pediatric FDA clearance builds on our successful track record in the safe administration and promising efficacy signals observed in adult patients with more common central nervous cancers,” said Marc Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “We expect REYOBIQ will offer much needed hope to children with aggressive and difficult-to-treat brain cancers and their families.”
REYOBIQ is a novel radiotherapeutic designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue. The ReSPECT-PBC (pediatric brain cancer) trial builds on promising preclinical data and clinical results from the Company’s adult recurrent glioblastoma trial (ReSPECT-GBM). As recently published in Nature Communications, ReSPECT-GBM demonstrated favorable safety and clinical response with a doubling of overall survival for those patients receiving a therapeutic dose of radiation defined as > 100 Gy.
For more information, please contact @plustherapeutics.com or visit https://www.clinicaltrials.gov (identifier to be assigned upon registration).
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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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 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) and pediatric brain cancer (PBC). 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/.
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 trial design, clinical outcomes, product candidates, 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; 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; 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 www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be incorrect 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
subslover
2 weeks ago
NEWS:Plus Therapeutics Announces FDA Clearance of its Investigational New Drug Application using REYOBIQTM for the Treatment of Childhood Brain Cancer
Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense
Trial will enroll children with high grade glioma and ependymoma
HOUSTON, June 25, 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, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application (No. 168178) for REYOBIQTM (Rhenium Re186 Obisbemeda) for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma (HGG) and ependymoma. The trial will be referred to as the ReSPECT-PBC trial and is funded by a $3.0M research grant from the U.S. Department of Defense.
"We are very excited for the opportunity to study the novel radiotherapeutic, REYOBIQ, in difficult-to-treat pediatric brain tumors. Surgery and external beam radiation have been the mainstays of treatment for pediatric high-grade glioma and, sadly, outcomes have not improved for many decades. We believe this novel therapy that may allow higher doses of radiation while limiting the exposure to normal developing brain and delivering this agent via convection enhanced delivery (CED) directly into the tumor has the potential to make a big difference in our patients' lives and improve outcomes,” said Dr. Ashley S. Plant, M.D., Principal Investigator for the trial, attending physician in Hematology, Oncology, Neuro-oncology, and Stem Cell Transplantation at Ann & Robert H. Lurie Children's Hospital of Chicago, A.M. Khokhar Research Scholar and Associate Professor of Pediatrics at Feinberg School of Medicine Northwestern University. “I am extremely passionate about bringing this therapy into the pediatric space and hopeful about the benefits to my patients."
Phase 1/2a Trial Design Highlights:
The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose (MTD), safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years (with consideration for patients up to 25 years on a case-by-case basis).
Key elements of the trial design include:
Phase 1a/b (Dose Escalation): This phase will enroll an estimated 24 patients using a modified 3+3 dose escalation scheme to establish the MTD and recommended Phase 2 dose (RP2D). Safety assessment and alignment with the FDA will occur at defined intervals.
Phase 2a: This phase will enroll approximately 32 patients (12 with ependymoma and 20 with HGG) at the RP2D to assess efficacy.
Pediatric 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. REYOBIQ’s targeted delivery via CED bypasses the blood-brain barrier, offering a novel approach to potentially improve outcomes for these patients.
“This pediatric FDA clearance builds on our successful track record in the safe administration and promising efficacy signals observed in adult patients with more common central nervous cancers,” said Marc Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “We expect REYOBIQ will offer much needed hope to children with aggressive and difficult-to-treat brain cancers and their families.”
REYOBIQ is a novel radiotherapeutic designed to deliver high doses of beta radiation directly to brain tumors while minimizing damage to surrounding healthy tissue. The ReSPECT-PBC (pediatric brain cancer) trial builds on promising preclinical data and clinical results from the Company’s adult recurrent glioblastoma trial (ReSPECT-GBM). As recently published in Nature Communications, ReSPECT-GBM demonstrated favorable safety and clinical response with a doubling of overall survival for those patients receiving a therapeutic dose of radiation defined as > 100 Gy.
For more information, please contact @plustherapeutics.com or visit www.clinicaltrials.gov (identifier to be assigned upon registration).
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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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 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 cent
Paulness
2 weeks ago
NEWS -- Plus Therapeutics Announces Comprehensive Restructuring of $15 Million March 2025 Equity Financing
Comprehensive restructuring eliminates the potential issuance of up to 1.5 billion shares of common stock
Plus Therapeutics files a request to withdraw the related resale registration statement with the SEC
HOUSTON, June 24, 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 a comprehensive restructuring of its previous $15 million equity financing announced on March 4, 2025. This strategic restructuring eliminates potential dilution of up to 1.5 billion shares of common stock, which the Company believes will significantly enhance shareholder value and position the Company to move forward with a more straightforward equity capital structure.
KEY HIGHLIGHTS OF THE EQUITY FINANCING RESTRUCTURING
Elimination of Dilutive Warrants: The restructuring cancels warrants associated with the equity financing, which could have resulted in the issuance of up to 1.5 billion shares of common stock, leaving approximately 36 million shares of common stock issuable upon exercise of amended Series B Warrants at an alternative cashless exercise ratio of 1:1
Cancellation of Common Stock and Pre-Funded Warrants (PFWs): The restructuring will lead to the cancellation of approximately 25 million shares of common stock (or PFWs in lieu), further reducing stockholder dilution
Future Financing Provisions: The Company will use 90% of future proceeds from any capital raised subsequent to July 1, 2025 to repay the holders of 22,727,270 shares of common stock (or PFWs in lieu) at 115% of the price originally paid for such securities in the March 2025 Equity Financing, based on an effective initial price of $0.66 per sharePlus Therapeutics has also filed a request with the U.S. Securities and Exchange Commission (the “SEC”) to withdraw the resale registration statement related to the March 2025 Equity Financing. The Company would like to thank all parties involved in the transaction for their contribution to completing this fundamental restructuring. For more information, please refer to the Current Report on Form 8-K filed with the SEC on June 17, 2025, which can be found here.
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 potential dilution of the March 2025 Equity Financing, the impact that the restructuring referred to herein will have on shareholder value and the Company’s equity capital structure, clinical outcomes, 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; risks related to the realization by shareholders of anticipated value from the restructuring referred to herein, as well as general market perception of the restructuring, 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 www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be incorrect 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
Note: Metric based on the maximum dilutive impact of the March 2025 Equity Financing, as of March 4, 2025, the closing date of such transaction, which assumes (i) a Reset Price equal to the Floor Price in each of the Series A Warrants and Series B Warrants, and (ii) use of the “alternative cashless exercise” feature in the Series B Warrants at a ratio of 3:1 at the time of exercise by the holders thereof.
Paulness
2 months ago
NEWS -- Plus Therapeutics, Inc. Receives Notification of Deficiency from Nasdaq Related to Delayed Filing of Quarterly Report on Form 10-Q
HOUSTON, May 23, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”) today announced it received a delinquency notification letter from Nasdaq on May 21, 2025, which indicated that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of the delayed filing of the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2025 (the “Quarterly Report”). The Nasdaq Listing Rule requires listed companies to timely file all required periodic financial reports with the U.S. Securities and Exchange Commission (the “SEC”). This notification has no immediate effect on the listing of the Company’s securities on Nasdaq.
Nasdaq has informed the Company that it must submit a plan to regain compliance with respect to the filing requirement by July 21, 2025. If the plan is accepted, Nasdaq can grant an exception of up to 180 calendar dates from the due date of the filing, or until November 17, 2025, to regain compliance.
The Company is working diligently to file the Quarterly Report as promptly as practical, and expects to return to a normal filing cadence for the remainder of 2025.
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/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based upon current expectations or beliefs, as well as assumptions about future events. Forward-looking statements include all statements that are not historical facts and can generally be identified by terms such as “expect,” “plan,” or “potential,” or similar expressions and the negatives of those terms. These statements include, but are not limited to, statements relating to the Company’s plans and expectations about the completion and filing of the Quarterly Report on Form 10-Q for the period ended March 31, 2025, its submission of a plan to regain compliance with respect to the Nasdaq Listing Rule, and the timing thereof. Actual results could differ materially from those expressed in or implied by the forward-looking statements due to a number of risks and uncertainties, including but not limited to, uncertainties about the timing of the Company’s submission of a compliance plan, Nasdaq’s acceptance of any such plan, the duration of any extension that may be granted by Nasdaq, the potential inability to meet Nasdaq’s requirements, the Company’s preparation of the Quarterly Report on Form 10-Q for the period ended March 31, 2025 and the related financial statements, the possibility of additional delays in the filing of the Quarterly Report on Form 10-Q for the period ended March 31, 2025, and the other risks and uncertainties described in the Company’s SEC reports and under the heading “Risk Factors” in its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release. Except as required by law, the Company does not undertake any obligation to update or revise its forward-looking statements to reflect events or circumstances after the date of this press release.
Contact Information
Andrew Sims, CFO
Plus Therapeutics, Inc.
737-255-7194
mailto://ir@plustherapeutics.com
Paulness
2 months ago
NEWS -- Plus Therapeutics’ REYOBIQ™ Shows Clinical Benefit and Safety in the ReSPECT-LM Clinical Trial for Patients with Leptomeningeal Metastases (LM)
Multiple long-term LM survivors in those patients receiving multiple doses of REYOBIQ
RNA sequencing data show early tumor apoptosis and activation of innate immune responses
Updated ReSPECT data presented at the 2025 Nuclear Medicine and Neurooncology Conference
HOUSTON, May 14, 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 presentation of new data on its lead drug REYOBIQ™ (rhenium Re186 obisbemeda) during both an oral presentation and a poster presented at the Nuclear Medicine and Neurooncology Conference. The meeting was held May 9-10, 2025 in Vienna, Austria.
"This newly presented data shows safety, clinical benefit and data supporting the underlying mechanism of action for REYOBIQ in patients with Leptomeningeal Metastases," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Furthermore, multiple doses of REYOBIQ were administered under compassionate use, mirroring how REYOBIQ may one day be used post approval and can contribute to long term survival in LM.”
The study, titled, “Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases,” highlights additional data from the Company’s now complete Phase 1 ReSPECT-LM dose escalation trial. The presented data added further detail to the previously reported data from the submitted abstract, which demonstrated:
Dose dependent increase in the average absorbed dose to the cranial and spinal subarachnoid space reaching 253Gy in Cohort 5
Neuroimaging response data was available for 17 patients as of the data cutoff with five of those (29%) showing a partial response
An additional eight patients showed stable disease by neuroimaging through day 112 for a Clinical Benefit Rate (complete response + partial response + stable disease) of 76% (13/17 – five partial responses and eight stable disease). Additionally, 87% of subjects demonstrated clinical response based on the physician evaluation (13/15 – 2 response and 11 stable disease)
No dose limiting toxicity (DLT) observed in the first four cohorts, with a grade 4 DLT (thrombocytopenia), one in each of Cohorts 5 and 6
RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an increase in T cells and an adaptive immune response by Day 28.
In addition, of the seven patients who received a response of better than 80% in reduction of LM tumor cells in the cerebrospinal fluid, five survived at least one year following initial treatment.
The study reports that three of those five were retreated via compassionate use.Further details from the poster can be found here.
About Leptomeningeal Metastases (LM)
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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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).
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/.
Investor Contact
CORE IR
mailto://investor@plustherapeutics.com
Paulness
2 months ago
NEWS -- Plus Therapeutics to Participate in the D. Boral Capital Inaugural Global Conference
HOUSTON, May 08, 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 that it will participate in the D. Boral Capital Inaugural Global Conference. The conference is being held on May 14, 2025, at The Plaza Hotel, 768 Fifth Avenue, New York, NY 10019.
Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer, will be hosting one-on-one meetings on May 14, 2025 from 9:00 AM to 3:00 PM (ET).
To register for one-on-one meetings with management at The Plaza Hotel in New York City, interested parties should contact John Perez at mailto://jperez@dboralcapital.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://plustherapeutics.com/.
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 and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases. The Company is planning to commercialize CNSide™ in the U.S. in 2025.
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, 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 promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts.
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 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 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 months ago
NEWS -- Plus Therapeutics Announces Biotech Industry Veteran Kyle Guse Joins its Board of Directors
HOUSTON, April 23, 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 appointment of Kyle Guse, J.D., M.B.A. to the Company’s Board of Directors where he will serve as chair of the Audit Committee and on the Compensation Committee.
“Kyle’s decades of financial, transactional and operational experience in our industry will make an immediate and positive impact to Plus’ board of directors,” said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. “Furthermore, in his role as audit chair, Kyle will be a force in the successful execution of Plus’ ambitious business plan and driving stockholder value.”
Mr. Guse is an executive with 30 years of professional experience leading the world’s most innovative companies. For over a decade he served as Chief Financial Officer, General Counsel and Secretary of Atossa Therapeutics, Inc., a NASDAQ-listed company developing a drug to prevent and treat breast cancer, which had previously developed and marketed medical devices, and that owned and operated a CLIA certified laboratory. Currently, he serves as Chief Legal Officer of DDC Enterprise Ltd., an NYSE-listed international consumer foods company.
Formerly, he was a partner and practiced corporate law at several of the top international law firms. Prior to that, he was a Certified Public Accountant with a Big 4 accounting firm. He earned his J.D. (cum laude) from Santa Clara University Law School and an M.B.A. from California State University, Sacramento, where he also earned his Bachelor of Science degree.
“Plus Therapeutics has multiple and significant opportunities in both the therapeutics and diagnostics markets with REYOBIQ™ (rhenium Re186 obisbemeda) and CNSide, and I believe it has tremendous potential to make an impact on the market,” said Mr. Guse. “I’m looking forward to collaborating closely with the Board and with management to help bring the Company to its full potential for stockholders, practitioners, and patients.”
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, 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 promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts.
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 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 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 months ago
NEWS -- Plus Therapeutics Presents New Data Highlighting Clinical Benefit and Safety of REYOBIQ in the ReSPECT-LM Clinical Trial for Patients with Leptomeningeal Metastases
New abstract published ahead of the Nuclear Medicine and Neurooncology Conference shows promise for REYOBIQ
HOUSTON, April 15, 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 online availability of new data on its lead compound REYOBIQ™ (rhenium Re186 obisbemeda) in an abstract for both an oral presentation and a poster to be presented at the Nuclear Medicine and Neurooncology conference to be held May 9-10, 2025 in Vienna, Austria.
The abstract, titled, “Rhenium Obisbemeda (REYOBIQ) in Leptomeningeal Metastases,” highlights additional data from the Company’s completed Phase 1 ReSPECT-LM dose escalation trial demonstrating a dose dependent increase in the average absorbed dose to the cranial and spinal subarachnoid space reaching 253Gy in Cohort 5. Neuroimaging response data was available for 16 patients as of the data cutoff with five of those (31%) showing a partial response. An additional seven patients showed stable disease by neuroimaging through day 112 for a Clinical Benefit Rate (complete response + partial response + stable disease) of 75%. Additionally, a clinical response based on the physician evaluation showed a decrease in disease findings in two of 14 evaluable patients (14%) and 10 patients showed stable findings through day 112 for an 86% Clinical Benefit Rate. Furthermore, there was no dose limiting toxicity (DLT) observed in the first four cohorts, with a grade 4 DLT (thrombocytopenia), one in each of Cohorts 5 and 6.
Finally, RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an increase in T cells and an adaptive immune response by Day 28. Further details can be found here; the Company will provide additional data and explanation following the meeting.
"This newly-presented ReSPECT-LM data further reinforces our confidence in the potential utility of REYOBIQ in these critically ill patients with the devastating diagnosis of Leptomeningeal Metastases," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Reyobiq can be delivered at very high doses of radiation to the cancer at the recommended phase 2 dose and shows promising response data across multiple parameters while simultaneously being well tolerated by normal organs and tissues."
About Leptomeningeal Metastases (LM)
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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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).
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, 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 promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts.
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 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 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 months ago
NEWS -- Plus Therapeutics Inc (PSTV) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
Plus Therapeutics Inc (PSTV) reports promising clinical progress and strategic funding, despite financial hurdles in its latest earnings call.
Summary:
Cash and Investments Balance: $3.6 million as of December 31, 2024, compared to $8.6 million at December 31, 2023.
Grant Revenue: $5.8 million in 2024, up from $4.9 million in 2023.
Operating Loss: $14.7 million in 2024, compared to $13.3 million in 2023.
Net Loss: $13 million or $0.95 per share in 2024, compared to $13.3 million or $4.24 per share in 2023.
Equity Financing: $15 million in gross proceeds from an underwritten equity financing in early March 2025.
Grant Funding for 2025: Expected to be in the range of $6 to $8 million.
Additional Grant Proceeds: $7.2 million remaining to be received from grants, with $2 million received in Q1 2025.
Department of Defense Grant: Over $2 million remaining from a $3 million award for the Respect pediatric brain cancer trial.Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
Plus Therapeutics Inc (PSTV, Financial) successfully completed an underwritten equity financing of $15 million, strengthening its balance sheet and funding key milestones into mid-2026.The company received FDA orphan designation for its lead drug, Robic, for use in patients with leptomeningeal metastasis (LM) due to lung cancer, adding to previous designations for breast cancer.Plus Therapeutics Inc (PSTV) has expanded its senior leadership team with experienced professionals in oncology and diagnostics, enhancing its clinical and commercial capabilities.The company reported promising clinical data for its lead drug, Robic, in phase one trials, showing a median overall survival of 9 months for LM patients, compared to the historical 4 months.Plus Therapeutics Inc (PSTV) is on track to launch its CNI tumor cell enumeration test commercially in 2025, which could significantly increase the total addressable market for Robic.Negative Points
The company's cash and investments balance decreased from $8.6 million at the end of 2023 to $3.6 million at the end of 2024, indicating a need for careful financial management.Plus Therapeutics Inc (PSTV) reported an operating loss of $14.7 million in 2024, up from $13.3 million in 2023, primarily due to increased spending on clinical trials.The net loss for 2024 was $13 million, which, although slightly lower than 2023, still reflects significant financial challenges.The company faces uncertainties related to FDA approval processes and the need for further clinical trials to validate its drug's efficacy and safety.Plus Therapeutics Inc (PSTV) must navigate complex market access activities, including state licensures and payer agreements, to successfully commercialize its CNI test.Q & A Highlights
Q: On the CN insight, do you anticipate building up a major sales force or will you look for partners to commercialize this?
A: Marc Hedrick, President and CEO: We do not plan to build a major sales force. This is a niche opportunity, and we are starting with academic neuro-oncologists at major oncology centers. There are about 300 neuro-oncologists in the country, and our initial focus will be on this narrow group of thought leaders and major institutions. Over time, we may expand to the broader medical oncology market. Partnering in the US or outside is something we will consider in the future.
Q: The recurrent GBM trial is the most advanced. What must happen to meet the goal of data this year?
A: Marc Hedrick, President and CEO: Although superficially GBM is in late-stage phase two, LM could get approved before. We've enrolled over 50 patients, completed phase one, and are over halfway through phase two. The key is adding new sites, and we now have five sites enrolling. We are focused on completing the enrollment of 11 more patients this year.
Q: Can you remind me of the powering assumptions behind the GBM trial?
A: Marc Hedrick, President and CEO: The phase two trial's comparator is the standard of care. We've conducted real-world control arms, and patients treated with monotherapy live under 8 months. The trial is powered at 80% with a comparator of about 8 months median overall survival. The trial size is around 100 to 150 patients, and discussions with the FDA about using real-world control data could reduce the number of active patients needed.
Q: On the LM study, you proposed a dose expansion at the 44 milli dose. Is that an additional cohort to the phase one study or part of the phase two study?
A: Marc Hedrick, President and CEO: Ideally, the FDA would sign off on a phase 2 trial focused on breast cancer, with 15 patients each for HER2 positive and negative at the 44 milli dose. The phase one dose is a basket trial including various cancer patients. The goal is to sort out patient segmentation by molecular subtype and align with the FDA on endpoints, potentially leading to a phase 2 or phase 23 pivotal design.
Q: Regarding the multi-dose study, would you wait for the first data to come out before initiating a phase two, or would you build that into a phase two?
A: Marc Hedrick, President and CEO: We plan to move directly into a phase two or phase 1B. The multi-dose data will be important for performance data and trial design. The phase one data is promising, with long tail survival observed. We aim to pursue a single dose approval quickly, with dose optimization layered on as data becomes available.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Paulness
4 months ago
NEWS -- Plus Therapeutics Introduces REYOBIQ™, FDA-Accepted Proprietary Name for Lead Drug Candidate
REYOBIQ™ (rhenium Re186 obisbemeda) continues to be under clinical investigation for Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM)
HOUSTON, March 20, 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, today announces the U.S. Food and Drug Administration (FDA) has conditionally accepted the Company’s new proprietary name, REYOBIQ™, for its lead therapeutic candidate. A request for proprietary name review for REYOBIQ™ must be submitted once the marketing application (NDA) is submitted. All communications regarding the USAN-adopted and INN-recommended rhenium Re186 obisbemeda generic name will now utilize the proprietary name REYOBIQ™.
"Branding is an important part of preparing for commercialization, and the establishment of the REYOBIQ™ brand will enable investigators, investors, and potential patients to connect with our rhenium-based radiotherapeutic beyond its chemical identity," said Russ Havranek, Plus Therapeutics VP of Corporate Strategy and New Product Planning. "We are looking forward to building familiarity with the new REYOBIQ™ name and logo, as we believe it will foster stronger stakeholder engagement and reinforce the promising progress we are making in developing targeted radiotherapeutics for LM and GBM.”
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 and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM 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).
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/.
Investor Contact
Jules Abraham
Managing Director, Communications
CORE IR
mailto://Julesa@coreir.com
Paulness
4 months ago
NEWS -- Plus Therapeutics to Announce Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call on March 27, 2025
HOUSTON, March 19, 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, today announces that the Company will report fourth quarter and full year 2024 financial results on Thursday, March 27, 2025 after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Webcast and Conference Call
Date/Time: Thursday, March 27, 2025 @ 5:00 PM ET
Webcast: https://edge.media-server.com/mmc/p/5r5hkcqq
Dial-in Link: https://register-conf.media-server.com/register/BI74b28f5ee02c4c1c89a835bfb6bdc1c8
Participants are encouraged to pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
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, 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 under the heading Upcoming Events and Expected Milestones, and statements regarding the following: CLIA compliance certification of the Company’s Houston-based clinical laboratory; the potential promise of rhenium (186Re) obisbemeda; expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC clinical trials; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts;; development and utility of CNSide leptomeningeal metastases diagnostic test.
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 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, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; 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, 2023, 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
Jules Abraham
Managing Director, Communications
CORE IR
mailto://Julesa@coreir.com
Paulness
4 months ago
NEWS -- D. Boral Capital Served as Exclusive Placement Agent to Plus Therapeutics, Inc. (Nasdaq:PSTV) in Connection with its up to $15.0 Million Private Placement
HOUSTON, TX / ACCESS Newswire / March 11, 2025 / On March 4th, 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, announced the pricing of a private placement with gross proceeds to the Company expected to be approximately $15.0 million.
"This financing coupled with ongoing grant support strengthens our ability to rapidly advance our CNS cancer therapies," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "We remain focused on meeting key near term milestones and creating long-term value for our stockholders."
The offering consists of 28,042,140 common units (or pre-funded units), each consisting of (i) one (1) share of common stock or one (1) pre-funded warrant, (ii) one (1) Series A warrant to purchase one (1) share of common stock per warrant (the "Series A Warrants") and (iii) one (1) Series B warrant to purchase one (1) share of common stock per warrant (the "Series B Warrants" and together with the Series A Warrants, the "Warrants"). The offering price per common unit is $0.66 (or $0.659 for each pre-funded unit, which is equal to the offering price per common unit to be sold in the offering minus an exercise price of $0.001 per pre-funded warrant). Of the securities issued in the offering, 22,727,270 of the common units (or pre-funded units), are being issued in consideration of new capital subscriptions and 5,314,870 are being issued in exchange for the cancelation of previously issued outstanding senior convertible promissory notes. The pre-funded warrants will be immediately exercisable and may be exercised at any time until exercised in full. For each pre-funded unit sold in the offering, the number of common units in the offering will be decreased on a one-for-one basis. The initial exercise price of each Series A Warrant is $1.32 per share of common stock. The Series A Warrants are exercisable following stockholder approval and expire 60 months thereafter. The number of shares of common stock issuable under the Series A Warrants is subject to adjustment as described in more detail in the report on the Company's Current Report on Form 8-K that will be filed with the U.S. Securities and Exchange Commission (the "SEC") in connection with the offering (the "Form 8-K"). The initial exercise price of each Series B Warrant is $1.98 per share of common stock or pursuant to an alternative cashless exercise option. The Series B Warrants are exercisable following stockholder approval and expire 30 months thereafter. The number of shares of common stock issuable under the Series B Warrants is subject to adjustment as described in more detail in the Form 8-K.
Aggregate gross proceeds to the Company are expected to be approximately $15.0 million plus the benefit to the Company from the cancelation of the $3.2 million in principal amount of senior convertible notes exchanged in the offering. The transaction is expected to close on or about March 4, 2025, subject to the satisfaction of customary closing conditions. The funds received in the offering will be placed in escrow, subject to release only upon confirmation that the Company will not be delisted pursuant to the previously disclosed Nasdaq hearings process. If the Company does not receive confirmation from Nasdaq by March 31, 2025, the offering will be terminated and the funds returned to the investors. The Company expects to use the net proceeds from the offering for the repayment of the Company's outstanding balance on its outstanding promissory notes not exchanged in the offering, repurchase of certain outstanding warrants and general corporate purposes and working capital.
D. Boral Capital is acting as the Placement Agent for the offering. Hogan Lovells US LLP is acting as counsel to the Company. Sichenzia Ross Ference Carmel LLP is acting as counsel to D. Boral Capital.
The securities described above are being sold in a private placement transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the common stock and the shares issuable upon exercise of the pre-funded warrants and Warrants.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such 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
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 for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and LM. The Company has built a supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. The Company is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs, including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About D. Boral Capital
D. Boral Capital LLC is a premier, relationship-driven global investment bank headquartered in New York. The firm is dedicated to delivering exceptional strategic advisory and tailored financial solutions to middle-market and emerging growth companies. With a proven track record, D. Boral Capital provides expert guidance to clients across diverse sectors worldwide, leveraging access to capital from key markets, including the United States, Asia, Europe, the UAE, and Latin America.
A recognized leader on Wall Street, D. Boral Capital has successfully aggregated over $23 billion in capital since its inception in 2020, executing approximately 300 transactions across a broad range of investment banking products.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements," within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, related to, including but not limited to, the financing, the total investment amount raised in connection with the offering, the timing of the closing of the offering, the potential exercise of the pre-funded warrants and Warrants and gross proceeds generated by the Warrants exercise, the Company's clinical programs, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. We may, in some cases use terms such as "future," "possible," "believes," "potential," "continue," "expects," "plans," "may," "could," or "will," or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including, but not limited to, the timing for the closing of the offering, potential gross proceeds resulting from the financing (including whether funds are released from escrow), potential gross proceeds resulting from the exercises of the warrants sold and issued in the financing, use of the financing proceeds, including the development of the Company's CNS cancer therapies, and achievement of key milestones with respect to the Company's product candidates and therapies. Results or events in future periods 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: Nasdaq does not provide the required confirmation; 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, including the ability of the Company to come into compliance with The Nasdaq Capital Market listing requirements; 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, 2023, 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.
For more information, please contact:
D. Boral Capital LLC
Email: mailto://info@dboralcapital.com
Telephone: +1(212)-970-5150
SOURCE: D. Boral Capital LLC
Paulness
4 months ago
NEWS -- Plus Therapeutics Regains Compliance with Nasdaq Minimum Stockholders’ Equity Requirement
HOUSTON, March 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that on March 7, 2025 the Company received confirmation from Nasdaq that the Company has regained compliance with Nasdaq’s minimum stockholders’ equity requirement. The Company’s common stock will continue to be listed and traded on The Nasdaq Capital Market.
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/.
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 and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases. The Company is planning to commercialize CNSide™ in the U.S. in 2025.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, related to the Company’s ability to comply with the continued listing requirements of Nasdaq. All statements in this press release, other than statements of historical fact are forward-looking statements. We may, in some cases use terms such as “will,” “believe,” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Results or events in future periods 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 ability of the Company to maintain compliance with Nasdaq continued listing requirements; 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. The Company 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 the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2023, 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 the Company might make or by known or unknown risks, uncertainties, and other factors, including those identified in this Current Report. Accordingly, you should not place undue reliance on the forward-looking statements made in this Current Report, 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
Jules Abraham
Managing Director, Communications
CORE IR
mailto://Julesa@coreir.com
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