Tillkännagivande • Jun 30
Plus Therapeutics Advances REYOBIQ Clinical Trials and Manufacturing Progress Plus Therapeutics, Inc. announced that REYOBIQ, or rhenium-186 obisbemeda, remains the therapeutic foundation of the company’s CNS oncology strategy. Plus Therapeutics continues to advance REYOBIQ across leptomeningeal metastases (LM), recurrent glioblastoma (GBM) and pediatric brain cancer (PBC). For 2026, Plus Therapeutics continues to focus on defining the optimal dose and dosing interval for REYOBIQ in the ReSPECT-LM Phase 2 trial, continuing to advance the ReSPECT-GBM Phase 2 trial toward completion of enrollment and the next regulatory discussion with the U.S. Food and Drug Administration (FDA), completing commercial manufacturing scale-up for REYOBIQ, and beginning enrollment in the ReSPECT-PBC Phase 1 pediatric brain cancer trial. In the ReSPECT-LM Phase 2 trial, Plus Therapeutics expects the optimal dose and interval to be consistent with previously released clinical data and believes this may be achieved with 12 to 18 patients, assuming no dose-limiting toxicities, which have not been observed to date. The company has enrolled approximately one-third of this target and, with ongoing site expansion, may reach a recommended Phase 2 dose by year end. In ReSPECT-GBM, Plus Therapeutics has enrolled 31 of the target 34 subjects. Current enrollment rates support full enrollment in 2026 at 3 active sites. Following completion of the current study and an end-of-Phase 2 meeting with the FDA, the company believes it may be positioned to move toward a registration study, subject to the final clinical data and related business considerations. Plus Therapeutics also continues to advance commercial manufacturing scale-up for REYOBIQ. Recommendations from the company’s Type C meeting with the FDA regarding purification qualification and impurity characterization activities have been completed or remain on schedule to be completed by year-end. Method transfer has been initiated, personnel have been trained, qualification activities are progressing to schedule and a Fourth Quarter audit is planned for the company’s new CDMO. The company has also completed its supply roadmap, including resolution of an overnight delivery constraint with a new vendor. For ReSPECT-PBC, the company has received both U.S. Department of Defense and Institutional Review Board approval to conduct the pediatric brain cancer study. Contracting with Lurie Children’s Hospital has been completed, site activation is in progress and first dosing is expected in the third quarter of 2026. New Risk • May 28
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$22m Forecast net loss in 3 years: US$5.1m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Shares are highly illiquid. Shareholders have been substantially diluted in the past year (over 9x increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.1m net loss in 3 years). Market cap is less than US$100m (€39.1m market cap, or US$45.6m). Tillkännagivande • May 26
Plus Therapeutics Presents Health Economics Study Demonstrating Substantial Healthcare Cost Reduction with CNSide Diagnostic Platform Plus Therapeutics, Inc. announced the presentation of a new health economics study evaluating the economic impact of earlier detection and therapeutic management of LM using the CNSide cerebrospinal fluid (CSF) assay. The Company believes that this cost-of-care analysis underscores that earlier LM diagnosis and therapeutic management enabled by CNSide may reduce overall LM-related healthcare costs by approximately 33-47%. These savings are driven by earlier therapeutic intervention, improved treatment precision, and reduced hospitalizations. Further, the recently announced payer agreements validate the findings as Plus continues commercialization of the assay in the United States. The data was presented at the ISPOR 2026 Annual Meeting, the leading global scientific conference focused on health economics and outcomes research (HEOR), bringing together researchers, healthcare decision-makers, and payer stakeholders. The meeting took place May 17-20, 2026, in Philadelphia, PA. The poster, titled, “Economic Impact of Earlier Detection and Therapeutic Management of Leptomeningeal Metastases Using CNSide: A Cost-of-Care Analysis,” co-authored by CNSide Diagnostics and Harvard T.H. Chan School of Public Health, highlighted the following: Late-stage LM diagnosis is associated with substantial healthcare costs, including median inpatient admissions of ~$20,000 (Interquartile range (IQR) $10,000-$30,000). Total LM-related costs may exceed $100,000 per month, driven by repeated imaging, LM-directed therapies, and palliative care. Earlier detection and treatment optimization enabled by CNSide may reduce overall LM-related healthcare costs by ~40% (33%-47%). Potential savings are driven by earlier therapeutic intervention, improved treatment precision, reduced adverse events and hospitalizations, and potential improvements in quality-adjusted outcomes. The analysis also highlights the challenges of quantifying LM costs due to claims bundling with primary cancer treatment. Notably, the poster received Blue Ribbon recognition, an honor awarded to the top 5% of presentations at ISPOR. The analysis utilized published literature, real-world data, and healthcare claims databases to estimate direct and indirect costs associated with late-stage LM diagnosis. Reported Earnings • May 20
First quarter 2026 earnings released: US$1.05 loss per share (vs US$738 loss in 1Q 2025) First quarter 2026 results: US$1.05 loss per share (improved from US$738 loss in 1Q 2025). Revenue: US$1.03m (down 2.9% from 1Q 2025). Net loss: US$6.95m (loss narrowed 48% from 1Q 2025). Revenue is forecast to grow 56% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 83% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings. Tillkännagivande • Apr 25
Plus Therapeutics Inc Initiates Manufacturing Activities With SpectronRx Under A Master Services Agreement To Support GMP Pivotal Trial Readiness For REYOBIQ Plus Therapeutics, Inc. announced the initiation of manufacturing activities and technology transfer with SpectronRx under a previously executed Master Services Agreement (MSA), in support of late-stage clinical manufacturing of Rhenium-186 and REYOBIQ. With SpectronRx serving as a second GMP manufacturing site alongside Radiomedix, and Rhenium-186 isotope supplied through Telix Pharmaceuticals, Plus strengthens the reliability of its multi-partner supply chain infrastructure. The MSA includes the technology transfer of the REYOBIQ manufacturing process, Rhenium-186 isotope processing, analytical methods, as well as technical and regulatory expertise supporting future commercial scale production. The SpectronRx’s facility in Indiana will provide on-demand manufacturing capabilities for both Rhenium-186 isotope production and REYOBIQ drug manufacturing within the same facility, improving coordination across the radiopharmaceutical production process and simplifying logistics. 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. Tillkännagivande • Apr 10
Plus Therapeutics, Inc. Appoints Eric J. Daniels as Chief Development Officer, Effective April 20, 2026 Plus Therapeutics, Inc. announced the appointment of Eric J. Daniels, M.D., MBA, as Chief Development Officer, effective April 20, 2026. Dr. Daniels is a seasoned biotechnology executive with more than two decades of experience spanning clinical development, regulatory strategy, corporate operations, and business development. He most recently served as Chief Development Officer at Kiora Pharmaceuticals, where he oversaw the company’s full development portfolio, including clinical, preclinical, and CMC activities, and worked closely with executive leadership and Kiora’s board of directors to define and execute development strategy. Dr. Daniels brings a unique combination of development and entrepreneurial experience, having co-founded Bayon Therapeutics and previously served as Chief Executive Officer of OccuRx, where he led all aspects of corporate strategy, clinical development, and operations. Earlier in his career, he held senior leadership roles at Cytori Therapeutics, Inc., where he contributed to global clinical development programs, strategic partnerships, and international commercialization initiatives. Dr. Daniels received his M.D. from the David Geffen School of Medicine at University of California Los Angeles and his MBA from the UCLA Anderson School of Management. He holds a Bachelor of Science in Molecular and Cell Biology from the University of California, Berkeley. Tillkännagivande • Apr 08
Plus Therapeutics Inc Receives AMA PLA Code for CNSide® CSF Tumor Cell Enumeration Test, Advancing Reimbursement and U.S. Commercial Adoption Plus Therapeutics, Inc. announced that the American Medical Association (AMA) has approved a new, Proprietary Laboratory Analyses (PLA) Current Procedural Terminology (CPT) code for its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) test. The dedicated billing code, 0640U, effective July 1, 2026, establishes a unique reimbursement identifier for the CNSide CSF TCE test, supporting payer claims processing and facilitating broader clinical adoptions as the Company continues the U.S. commercial launch of its CNS metastases diagnostic platform. Key implications of the newly assigned PLA code 0640U: Supports payer reimbursement processes. Provides a dedicated billing code specific to the CNSide CSF Tumor Cell Enumeration test, enabling standardized claims submission and facilitating payer coverage determinations. Facilitates clinician adoption. Simplifies ordering and billing processes for clinicians and cancer centers evaluating patients with suspected leptomeningeal metastases. Enables national utilization tracking. PLA coding allows tracking of test utilization through claims data, supporting real-world evidence generation related to clinical outcomes and health economics. Supports ongoing U.S. commercial launch. The coding milestone strengthens the reimbursement infrastructure supporting the Company’s ongoing U.S. launch of CNSide CSF test. Tillkännagivande • Mar 27
Plus Therapeutics, Inc. Announces Appointment of Ron Andrews to Its Board of Directors Plus Therapeutics, Inc. announced the appointment of diagnostics industry veteran Ron Andrews to its Board of Directors. Mr. Andrews currently is an experienced leader in the Diagnostics and Molecular Diagnostics industry with over 35 years leading various sized organizations from divisions of large global entities such as Abbott Diagnostics, Roche Molecular Diagnostics and LifeTechnologies/Thermo Fisher to public CEO roles in successful start-up organizations like Clarient Inc. and Oncocyte Inc. Most recently, Mr. Andrews has focused on assisting venture capital firms’ portfolio companies with interim CEO and Executive Chairman roles to bring emerging molecular technology companies through product development and fund-raising cycles. He has been instrumental in over $600M of capitalization for the various entities he has led or chaired and has led over $15B in exits over the course of his career. Mr. Andrews has held numerous board positions in public and private companies as well as served as a member of the Board of Governors of CancerLinQ LLC, a wholly-owned non-profit subsidiary of the American Society of Clinical Oncology. He currently serves on the Board of Trustees for Wofford College and several privately-held Molecular Diagnostic companies. Mr. Andrews graduated from Wofford College in 1981 with degrees in Biology and Chemistry. Tillkännagivande • Mar 14
Plus Therapeutics, Inc., Annual General Meeting, May 14, 2026 Plus Therapeutics, Inc., Annual General Meeting, May 14, 2026. Tillkännagivande • Feb 25
Plus Therapeutics, Inc. Announces New Category III CPT Code for Convection-Enhanced Delivery Used with REYOBIQ Plus Therapeutics, Inc. announced the American Medical Association's (AMA) CPT®? (Current Procedural Terminalology) Editorial Panel approved a new Category III CPT code to track utilization of convection-enhanced delivery (CED) used in the administration of REYOBIQ for recurrent glioblastoma (rGBM) and pediatric brain cancer (PBC). The approved Category III CPT code for convection-enhanced delivery of REYOBIQ in recurrent glioblastoma and pediatric brain cancer - the most prevalent malignant tumors of the brain and central nervous system - marks a major step in bringing market access for an innovative treatment targeting an aggressive and deadly disease resistant to conventional treatments. This milestone reflects the culmination of years of REYOBIQ development and represents an important advancement in path to commercialization and reimbursement. With standardized REYOBIQ clinical use now tracked under the new CPT code, its utilization can be evaluated as a bridge to approval and broad adoption. 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 $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-P BC 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. Tillkännagivande • Jan 22
Plus Therapeutics, Inc. Provides Business Update on REYOBIQ Clinical Program and U.S. CNSide Commercialization Plus Therapeutics, Inc. provided a business update and highlights REYOBIQ clinical progress and CNSide US commercialization. Overview of anticipated company milestones for 2026: REYOBIQ clinical program: Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in third quarter of 2026; Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an end of phase meeting with the FDA to align on pivotal trial design, with data expected in fourth quarter of 2026; Complete commercial manufacturing scale up for REYOBIQ; Begin enrollment in the ReSPECT -PBC pediatric brain cancer Phase 1 trial. REYOBIQ commercial roll out: Obtain a total of 150 million US lives covered under multiple commercial payor agreements; Obtain Medicare and Medicaid coverage; Achieve a commercial order rate in excess of 1,250 tests per year; Launch portfolio of additional CSF tumor characterization tests that expand the CNSide testing platform. CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. Tillkännagivande • Jan 14
Plus Therapeutics, Inc. has completed a Composite Units Offering in the amount of $15 million. Plus Therapeutics, Inc. has completed a Composite Units Offering in the amount of $15 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 39,473,684
Price\Range: $0.38
Discount Per Security: $0.0266 Tillkännagivande • Jan 08
Plus Therapeutics, Inc. Announces Read Out of Type B Meeting with the FDA with Goal of Accelerating Approval of REYOBIQ™? for Leptomeningeal Metastases Plus Therapeutics, Inc. announced the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA's feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company's goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM. Highlights of FDA responses to the Company's key enquiries: Accelerated approval - FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications. Primary and key endpoints - FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurological function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint. Trial design and comparator group - FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol. Treated populations - FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial. Tillkännagivande • Dec 04
Plus Therapeutics, Inc. Highlights Three REYOBIQ™ Clinical Data Presentations at 2025 WFNOS/SNO Annual Meeting Plus Therapeutics, Inc. announced three positive clinical data update presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO) Annual Meeting, November 19-23, 2025 in Honolulu, Hawaii. Phase 1 Multicenter Study of Multiple Doses of Rhenium (186Re) Obisbemeda (Reyobiq) for Leptomeningeal Metastases: Rationale, Design, and Preliminary Cohort 1 Data Overview: Completed ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed; ReSPECT-LM open label, multidose Phase 1/2 trial initiated to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response using CNSide CSF tumor cell enumeration test; Response: Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals; Three patients enrolled as of data cutoff: one patient has received all doses without dose limiting toxicity. Next steps: Phase 1b/2a dose optimization trial is enrolling with the ultimate goal of improving outcomes for LM patients; Phase 1/2 ReSPECT-GBM Trial of Rhenium (186 Re) Obisbemeda in Recurrent Glioblastoma: Safety and Efficacy from the Phase 1 and Update on Phase 2 Overview: Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. 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. Tillkännagivande • Nov 25
Plus Therapeutics, Inc. Announces Completion of U.S. FDA Meeting on Future Clinical Development Plans for Reyobiq in Leptomeningeal Metastases Plus Therapeutics, Inc. announced it has completed a Type B meeting with the U.S. Food and Drug Administration (FDA) on November 7th to discuss its REYOBIQ clinical development plans for leptomeningeal metastases (LM) including the design of a planned pivotal or registrational trial. Leptomeningeal metastases are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. Reyobiq 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 metastase, 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 $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-PBCclinical 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. Tillkännagivande • Oct 22
Plus Therapeutics, Inc. Promotes Russ Havranek to Executive Vice President, Commercial and Corporate Strategy Plus Therapeutics, Inc. to lead commercialization strategy, Russ Havranek, MS, MBA, has been promoted to Executive Vice President, Commercial and Corporate Strategy. Mr. Havranek assumes his new commercial and corporate strategy role focused on CNSide’s launch of its diagnostic platform, having most recently served as Vice President of Corporate Strategy and New Product Planning at Plus. He was previously Vice President of Global Marketing and Business Development at Cytori Therapeutics. Mr. Havranek has over 28 years of leadership experience developing and commercializing diagnostic and therapeutic products at global, publicly traded, biopharma and medical device companies. His prior roles in marketing, strategy, business development, general management, and R&D focused on the oncology, rare disease, cardiology, and orthopedic markets. These roles were held at Johnson & Johnson, Guidant (now Abbott), Genentech (now Roche), DJO Global (now Enovis), Volcano (now Philips), and CareFusion (now Becton Dickinson). Mr. Havranek received a MBA in Marketing from the Haas School of Business at the University of California, Berkeley, a MS in Bioengineering from Clemson University, and a BS in Biomedical Engineering from Northwestern University. Tillkännagivande • Sep 23
Plus Therapeutics Announces Additional $1.9 Million Advance Payment from CPRIT Plus Therapeutics, Inc. announced that the Company received notice of an additional advance payment from the Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally. This $1.9 million payment is part of the Company’s previously awarded $17.6 million grant and is the second non-dilutive financing received from CPRIT following the $1.6 million receipt announced in July 2025. The funding supports and accelerates the Company’s clinical development of REYOBIQ™ for the ReSPECT-LM dose optimization trial and further develops the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint. Tillkännagivande • Aug 19
Plus Therapeutics, Inc. Presents Positive ReSPECT-LM Clinical Trial Results of REYOBIQ in Leptomeningeal Metastases Plus Therapeutics, Inc. announced positive data from the ReSPECT-LM Phase 1 single dose escalation trial presented at the podium at the SNO/ASCO CNS Metastases Conference in Baltimore, MD. (Rhenium Nanoliposome,186RNL (REYOBIQ) for the Treatment of Leptomeningeal Metastases (LM): Clinical Study Results for Safety and Efficacy," highlighted study results to date from a total of 29 subjects in cohorts 1 - 6 who received 6.6 mCi, 13.2 mCi, 26.4 mCi, 44.10 mCi, 66.14 mCi, or 75mCi of REYOBIQ, respectively. Presented Data Highlights: Radiographic and clinical response rate of 76% and 87%, respectively, through day 112. CSF tumor cell enumeration (TCE) assays (CNSide test) showed a maximum reduction over baseline of 100% at day 28. Five of the 7 patients with a TCE response >80% survived at least 1 year. RNA sequencing of LM cells showed early induction of apoptosis, with an innate immune response followed by an adaptive immune response by day 28. Median overall survival of 9 months across cohorts 1-4 (20 patients) months, comparing favorably with literature reports of ~4 months. No dose-limiting toxicity (DLT) was observed in cohorts 1-4, with 1 DLT in each of cohorts 5 and 6 of grade 4 cytokenia. The majority of adverse events across the trial were Grade 1 and 2. Mean absorbed dose to the cranial and spinal subarachnoid space was 272 Gy in cohort 6. A recommended phase 2 single dose of 44.1 mCi was determined. 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. The Company's ReSPECT-PBCclinical 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. Tillkännagivande • Aug 14
Plus Therapeutics Presents Positive CNSide CSF Assay Platform Results at the 2025 SNO/ASCO CNS Metastases Conference Plus Therapeutics, Inc. announced positive data from a retrospective analysis of the CNSide Cerebrospinal Fluid (CSF) Assay Platform at the 2025 Society for Neuro-Oncology (SNO)/American Society of Clinical Oncology (ASCO) CNS Metastases Conference in Baltimore, Maryland. The presentation, titled "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," was a retrospective, multi-center analysis of 613 CNSide assays ordered by 19 physicians from 5 institutions at 2 health systems for 218 individual patients. 74% of the patients were female and the cancers most analyzed were breast (n=105) and lung (n=65). The research was presented by Priya U.Kumthekar, M.D., Professor of Neurology and Medicine at Northwestern University. Data Demonstrated: CSF tumor cells detected in 67% (412/613) patients using CNSide; 66 patients underwent 2 or more CSF draws; About 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. 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, but the actual incidence may be higher as it can be difficult to diagnose. Postmortem studies show the frequency of LM to be around 20% or more, highlighting healthcare providers' need for more sensitive diagnostic options. Tillkännagivande • Jul 31
Plus Therapeutics, Inc.'s subsidiary CNSide Diagnostics, LLC Provides US Launch Update for its CNSide®? Diagnostic Plus Therapeutics, Inc. announced that its wholly-owned subsidiary, CNSide Diagnostics, LLC will make CNSide cerebrospinal fluid (CSF) assay platform and testing services commercially available in Texas in August 2025. Initial commercial focus will be on National Cancer Institute (NCI) Designated Cancer Centers, which treat the highest number of patients at risk for leptomeningeal metastases (LM) and previously used CNSide. Physicians, providers, hospitals or clinics interested in CNSide should contact CNSide through website. The CNSide testing platform is a proprietary, laboratory-developed program designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas who are at risk of developing cancer of the central nervous system (CNS). CNS metastases are an epidemic affecting as many as 30% of adult cancer patients and affect the highly protected CNS space. The comprehensive CNSide CSF Assay is a highly sensitive tool 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 9 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 over 90% of cases. By comparison, CSF cytology, the current standard of care for CNS Mets diagnosis, was originally developed over a century ago and offers suboptimal test sensitivity leading to missed or delayed diagnosis and treatment. Leptomeningeal metastases are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. 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 metastase. Tillkännagivande • Jul 23
Plus Therapeutics, Inc. Receives Notice of an Advance Payment of $1.6 Million from the Cancer Prevention and Research Institute of Texas Plus Therapeutics, Inc. announced that the Company received notice of an advance payment of $1.6 million from the Cancer Prevention and Research Institute of Texas (CPRIT), the second-largest public cancer research funder globally, as part of the Company’s previously awarded $17.6 million grant. The funding supports and accelerates the Company’s clinical development of REYOBIQ for the ReSPECT-LM dose optimization trial and further develops the Company’s CNSide LM diagnostic test as a key pivotal trial endpoint. 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. 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. Tillkännagivande • Jul 14
Plus Therapeutics, Inc., Annual General Meeting, Aug 07, 2025 Plus Therapeutics, Inc., Annual General Meeting, Aug 07, 2025. Tillkännagivande • Jul 08
Plus Therapeutics, Inc. Announces Initial Patients Successfully Treated in ReSPECT-LM Dose Optimization Trial for REYOBIQ in Leptomeningeal Metastases Plus Therapeutics, Inc. 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. 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. 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. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastase, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. The Company's ReSPECT-PBCclinical 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. Tillkännagivande • Jul 01
Plus Therapeutics, Inc. Announces Fda Agreement to Initiate Respect-Lm Dose Optimization Trial for Reyobiq™? in Leptomeningeal Metastases Plus Therapeutics, Inc. announced the initiation of the ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM). 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 rate1 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 treatment. 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. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastase, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. The Company's ReSPECT-PBCclinical 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. Tillkännagivande • Jun 25
Plus Therapeutics, Inc. Announces FDA Clearance of Its Investigational New Drug Application Using Reyobiqtm for the Treatment of Childhood Brain Cancer Plus Therapeutics, Inc. 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. 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. REYOBIQ's targeted delivery via CED bypasses the blood-brain barrier, offering a novel approach to potentially improve outcomes for these patients. 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. REYOBIQ™? is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. 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. Tillkännagivande • Jun 09
Plus Therapeutics Receives a Letter from the Nasdaq Listing Qualifications Department of the Nasdaq Stock Market On June 3, 2025, Plus Therapeutics, Inc. received a letter from the Nasdaq Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company had regained compliance with the Rule 5250(c)(1) due to filing its Quarterly Report on Form 10-Q for the period ended March 31, 2025 (the “Quarterly Report”) with the U.S. Securities and Exchange Commission (the “SEC”) on May 30, 2025. As previously disclosed, on March 8, 2024, the Company received a written notice from the Staff, notifying the Company that it no longer complied with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity (the “Minimum Stockholders’ Equity Requirement”) for continued listing on The Nasdaq Capital Market or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years. On March 7, 2025, the Company received notification from Nasdaq that it had regained compliance with the Minimum Stockholders’ Equity Requirement and was subject to a Mandatory Panel Monitor until March 7, 2026. On June 3, 2025, the Staff notified the Company that it was not in compliance with the Minimum Stockholders’ Equity Requirement (the “June 3 Letter”). The Company reported stockholders’ equity (deficit) of ($23,641,000) in its Quarterly Report on Form 10-Q for the period ended March 31, 2025, and, as a result, did not satisfy the Minimum Stockholders’ Equity Requirement pursuant to Listing Rule 5550(b)(1). As a result, the Staff determined to delist the Company’s securities from Nasdaq, unless the Company timely requests an appeal of the Staff’s determination to a Hearings Panel (the “Panel”), pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series. The Company must request a hearing no later than 4:00 p.m. Eastern Time on June 10, 2025. The Company plans to request a hearing before the Panel to appeal the June 3 Letter and to address all outstanding matters, including compliance with the Minimum Stockholders’ Equity Requirement, which hearing date has not been set as of the date of this Current Report on Form 8-K (this “Form 8-K”). While the appeal process is pending, the suspension of trading of the Company’s common stock, par value $0.001 per share (the “Common Stock”), will be stayed and the Common Stock will continue to trade on the Nasdaq Capital Market until the hearing process has concluded and the Panel issues a written decision. The Company has been informed that hearings are typically scheduled to occur approximately 30-45 days after the date of the hearing request. There can be no assurance, however, that the Panel will grant the Company’s request for continued listing or that the Company will be able to demonstrate compliance with Nasdaq Listing Rule 5550(b)(1) within any additional compliance period that may be granted by the Panel. Tillkännagivande • May 26
Plus Therapeutics Receives Notification of Deficiency from Nasdaq Related to Delayed Filing of Quarterly Report on Form 10-Q Plus Therapeutics, Inc. 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. Tillkännagivande • May 20
Plus Therapeutics Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Requirement On May 16, 2025, Plus Therapeutics, Inc. (the Company") received notice from The Nasdaq Stock Market LLC (Nasdaq") that, because the closing bid price for the Company's common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Requirement"). Nasdaq's notice has no immediate effect on the listing or trading of the Company's common stock. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided an initial compliance period of 180 calendar days, or until November 12, 2025, to regain compliance with the Minimum Bid Requirement. To regain compliance, the closing bid price of the Company's common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to November 12, 2025. If the Company does not achieve compliance with the Minimum Bid Requirement by November 12, 2025, the Company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, with the exception of the Minimum Bid Requirement, and provide written notice of its intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split if necessary. If the Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company's common stock will be subject to delisting. In the event the Company receives notice that its common stock is being delisted, Nasdaq rules permit the Company to appeal any delisting determination by the Nasdaq staff. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Requirement or maintain compliance with the other listing requirements. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Requirement. Tillkännagivande • May 16
Plus Therapeutics, Inc. announced delayed 10-Q filing On 05/15/2025, Plus Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Apr 19
Plus Therapeutics, Inc. Announces Board and Committee Changes On April 18, 2025, the Board of Directors (the “Board”) of Plus Therapeutics, Inc. (the “Company”) unanimously appointed Mr. Kyle Guse to serve as a director of the Board, effective immediately. Mr. Guse is being appointed to the Board to fill the vacancy created by the resignation of Mr. Greg Petersen, and is expected to stand for reelection at the Company’s next annual meeting of stockholders. The Board has determined that Mr. Guse satisfies the definition of an “independent director” under the Nasdaq listing standards and the Company’s Corporate Governance Guidelines. Mr. Guse was also appointed to the Audit Committee and Compensation Committee of the Board and as Chairman of the Audit Committee. Mr. Guse currently serves as the Chief Legal Officer of DDC Enterprise Ltd., an NYSE-American-listed international consumer foods company, a position he has held since September 2023. From January 2013 to May 2023, Mr. Guse was Chief Financial Officer, General Counsel and Secretary of Atossa Therapeutics, Inc., a Nasdaq-listed biotechnology company developing treatments and prevention for breast cancer. Mr. Guse’s experience includes 30 years of counseling innovative, rapid growth companies through all aspects of finance, corporate governance, securities laws and commercialization, with a particular focus on mergers and acquisitions and capital markets transactions. Mr. Guse has practiced law at several of the largest international law firms, including from January 2012 through January 2013 as a partner at Baker Botts LLP and, prior to that, from October 2007 to January 2012, as a partner at McDermott Will & Emery LLP. Before working at McDermott Will & Emery, Mr. Guse served as a partner at Heller Ehrman LLP. Mr. Guse began his career as an accountant at Deloitte and he is an inactive Certified Public Accountant and member of the Bars in California and Washington. Mr. Guse earned a B.S. in business administration and an M.B.A. from California State University, Sacramento, and a J.D. from Santa Clara University School of Law. Tillkännagivande • Apr 15
Plus Therapeutics, Inc. Presents New Data Highlighting Clinical Benefit and Safety of REYOBIQ in the ReSPECT-LM Clinical Trial for Patients with Leptomeningeal Metastases Plus Therapeutics, Inc. announced 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. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapy 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. REYOBIQ™™ is being evaluated for the treatment of recurrent gllioblastoma and leptomeningeal metastases in the ReSPECT-GBM and ReSPECT-LM clinical trials. Tillkännagivande • Apr 01
Plus Therapeutics, Inc. has withdrawn its Follow-on Equity Offering in the amount of $16 million. Plus Therapeutics, Inc. has withdrawn its Follow-on Equity Offering in the amount of $16 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Security Name: Common Warrants
Security Type: Equity Warrant Tillkännagivande • Mar 20
Plus Therapeutics Introduces REYOBIQ, FDA- Accepted Proprietary Name for Lead Drug Candidate Plus Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has previously 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. REYOBIQ (rhenium Re 186 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 $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). Tillkännagivande • Mar 19
Plus Therapeutics, Inc. to Report Q4, 2024 Results on Mar 27, 2025 Plus Therapeutics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 27, 2025 Tillkännagivande • Mar 10
Plus Therapeutics Regains Compliance with Nasdaq Minimum Stockholder's Equity Requirement Plus Therapeutics, Inc. 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. Tillkännagivande • Mar 06
Plus Therapeutics, Inc. Receives U.S. FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda for the Treatment of Leptomeningeal Metastases in Patients with Lung Cancer Plus Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Rhenium (186Re) Obisbemeda for the treatment of leptomeningeal metastases (LM) in patients with lung cancer. The FDA grants ODD status to an investigational drug or biologic intended to prevent, diagnose, or treat a rare disease or condition affecting fewer than 200,000 people in the United States. ODD provides certain benefits to drug developers, including seven potential years of market exclusivity, tax credits for qualified clinical trials, and exemptions from significant regulatory fees, including the Prescription Drug User Fee Act (PDUFA) charge of $4.3 million in 2025 and the Pediatric Research Equity Act (PREA) requirements. The Company is now advancing a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial while actively engaging the FDA to define the optimal pivotal trial strategy. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapy 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. Rhenium (186Re") obisbemeda is being evaluated for the treatment of recurrent glioblastoma and leptomeningeal metastase in the ReSPECT-GBM and ReSPECT-LM clinical trials. Tillkännagivande • Feb 26
Plus Therapeutics, Inc. Advances Lead Drug Rhenium (186Re) Obisbemeda for Patients with Leptomeningeal Metastases Plus Therapeutics, Inc. announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined an RP2D. The ReSPECT-LM single-dose escalation trial assessed the safety, tolerability, and potential efficacy of intrathecally administered Rhenium (186Re) Obisbemeda in patients with leptomeningeal metastases (LM). Additional details on the ReSPECT-LM trial can be found here. 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 chemotherapy 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. Tillkännagivande • Feb 20
Plus Therapeutics, Inc. Appoints Michael Rosol as Chief Development Officer Plus Therapeutics, Inc. announced the appointment of Michael Rosol, Ph.D., as Chief Development Officer. Dr. Rosol will lead the company’s clinical, pre-clinical, and biomarker development activities. Dr. Rosol has 25 years of experience in clinical trial design, operations, and regulatory execution. Most recently, he served as Chief Medical Officer and Senior Vice President at Navidea Biopharmaceuticals. Prior to his most recent role, Dr. Rosol worked at Novartis Pharmaceuticals, leading key biomarker development and translational imaging groups. Dr. Rosol’s Ph.D. from Boston University focused on biomedical and radionuclide imaging, and he has held various academic appointments at Harvard Medical School/Massachusetts General Hospital, Mayo Clinic, Children’s Hospital of Los Angeles/USC Medical School, and the Medical University of South Carolina. Board Change • Dec 30
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Andrew Brenner was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Tillkännagivande • Dec 18
Plus Therapeutics, Inc. Presents Positive ReSPECT-LM Phase 1 Interim Data for Breast Cancer Patients with Leptomeningeal Metastases At the 2024 San Antonio Breast Cancer Symposium Plus Therapeutics, Inc. presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM) with a specific focus on breast cancer patients. The data were presented at the 2024 San Antonio Breast Cancer Symposium on December 10-13. The data were presented in a session titled ‘Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) for the Treatment of Leptomeningeal Metastases (LM): Update on Phase 1 Dose Escalation Study,’ by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio. Key Highlights from the Presentation: Nine of 20 patients with LM primary breast cancer were treated and evaluable through five dose escalation cohorts, with the maximum tolerated dose yet to be reached Primary breast cancer biomarker status across the 9 patients were: ER positive/HER2 negative: n=3 HER2 positive: n=2 Triple negative: n=4 Patients received a single intrathecal dose of Rhenium (186Re) Obisbemeda, ranging from 6.6 to 66.14 mCi of radiation Only one dose-limiting toxicity (thrombocytopenia) was reported (Cohort 5) A linear increase in absorbed dose was observed from Cohorts 1 through 5, with an average absorbed dose of 253 Gy to the cranial subarachnoid space in Cohort 5 Circulating tumor cell (CTC) and radiographic (MRI) response data were available for 8 of the 9 breast cancer patients with LM, and clinical response data were available for 7 of the 9 patients Best response rates (response only) were: CTC: 88% (7/8) MRI imaging: 25% (2/8) Clinical: 29% (2/7) Clinical benefit rates (response and stable disease) were: CTC: 100% (8/8) MRI imaging: 75% (6/8) Clinical: 71 % (5/7) Median overall survival for 9 breast cancer patients was 9 months, with 2 patients surviving beyond 600 days post-treatment Next steps: Initiate ReSPECT-LM Phase 1b single-dose breast expansion cohort in first quarter of 2025 to further evaluate single-dose safety and efficacy of Rhenium (186Re) Obisbemeda. Tillkännagivande • Nov 26
Plus Therapeutics Presents Positive ReSPECT-LM Phase 1 Interim Data for Leptomeningeal Metastases at the 2024 SNO Annual Conference Plus Therapeutics, Inc. presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM). The data were presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas. The data were presented in a session titled, “Rhenium (186Re) Obisbemeda (rhenium nanoliposome,186RNL) for the treatment of leptomeningeal metastases (LM): Summary of the Phase 1 dose escalation study and Phase 2 administered dose selection,” by Andrew Brenner, M.D., Ph.D., Professor and Kolitz/Zachry Endowed Chair Neuro-Oncology Research; Co-Leader, Experimental and Developmental Therapeutics Program, University of Texas Health, San Antonio. ReSPECT-LM Single Administration Dose Escalation Trial: Overview: Twenty patients with LM were treated and evaluable through Cohort 5, receiving a single intrathecal dose of Rhenium (186Re) Obisbemeda of up to 66.14 mCi of radiation. Primary cancer diagnosis for the 20 patients with LM included breast cancer (n = 9), non-small cell lung cancer (n = 5), and other primary cancers (n = 6). Safety: The safety profile through Cohort 5 was favorable, with 1 dose-limiting toxicity (thrombocytopenia) observed in Cohort 5. Pharmacodynamic and pharmacokinetic analyses indicated that after a single administration, Rhenium (186Re) Obisbemeda remained in the cerebrospinal fluid space for at least 7 days and achieved average absorbed doses of up to 253 Gy to the cranial subarachnoid space in Cohort 5. Response: The best clinical benefit rate from a single dose of Rhenium (186Re) Obisbemeda, assessed from baseline to day 112, was measured through complete response, partial response, and stable disease across three key metrics: Circulating tumor cells: 93% (14/15 patients) responded, including 1 complete response and 1 stable case. MRI imaging: 75% (12/16 patients), with 5 responses and 7 stable cases. Clinical Response: 86% (12/14 patients), with 2 responses and 10 stable cases. Median overall survival for Cohorts 1-4 was 9 months, with 6 out of the 16 patients alive at the time of analysis. Three of the 20 patients received up to 3 doses of Rhenium (186Re) Obisbemeda under compassionate use IND, all surviving over 400 days, with one exceeding 30 months. Next steps: The first patient in Cohort 6 has been treated using a modified dose of 75 mCi. Cohort 6 is anticipated to conclude in First Quarter 2025. Planning is underway for a Phase 1b single dose expansion cohort trial using the Cohort 4 dose of 44 mCi, which is expected to fully enroll in 2025. ReSPECT-LM Multiple Administration Dose Interval Compression Trial. Obtained agreement from FDA to begin the ReSPECT-LM multi-administration trial for patients with LM (IND 153715); enrollment is expected to begin in early 2025 at seven U.S. trial sites. The trial will be a two-part study aimed at evaluating the safety, dosing intervals, and efficacy of administering multiple doses of Rhenium (186Re) Obisbemeda to patients with LM. Tillkännagivande • Nov 22
CNSide Diagnostics, LLC to Present Positive FORESEE Clinical Trial Summary Demonstrating Utility of CNSide™ Cerebrospinal Fluid Assay in Diagnosis and Clinical Management of Patients with Leptomeningeal Metastases CNSide Diagnostics, LLC will present data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM. The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas. Key highlights: The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint target; CNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LM; CNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisions; CNSide exhibited high specificity, with no tumor cells detected in patients without LM; CNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%); CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies. Reported Earnings • Nov 17
Third quarter 2024 earnings released: US$0.37 loss per share (vs US$1.00 loss in 3Q 2023) Third quarter 2024 results: US$0.37 loss per share (improved from US$1.00 loss in 3Q 2023). Revenue: US$1.46m (up 17% from 3Q 2023). Net loss: US$2.87m (loss narrowed 11% from 3Q 2023). Revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 61% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings. New Risk • Nov 16
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.5% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-US$7.6m). Earnings are forecast to decline by an average of 2.5% per year for the foreseeable future. Market cap is less than US$10m (€7.06m market cap, or US$7.43m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$46m net loss in 3 years). Shareholders have been diluted in the past year (30% increase in shares outstanding). Tillkännagivande • Nov 05
Plus Therapeutics, Inc. to Report Q3, 2024 Results on Nov 14, 2024 Plus Therapeutics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 14, 2024 Tillkännagivande • Oct 01
Plus Therapeutics Reports ReSPECT-GBM Clinical Trial Update at the 2024 Congress of Neurological Surgeons Annual Meeting Plus Therapeutics, Inc. presented an update on the ongoing ReSPECT-GBM Phase 1/2 clinical trial, evaluating the Company’s lead asset Rhenium (186Re) Obisbemeda for the treatment of recurrent glioblastoma. The data were presented at the 2024 Congress of Neurological Surgeons (CNS) Annual Meeting on September 30, 2024, in Houston, Texas. The presentation, titled “Treatment of Recurrent Glioblastoma (rGBM) via Convection Enhanced Delivery (CED) with Rhenium (186Re) Obisbemeda (Rhenium-186 Nanoliposome, 186RNL): ReSPECT-GBM Phase 1/2 Trial Update” was delivered by lead investigator and neurosurgeon John Floyd, M.D., Associate Professor and Chair of the Department of Neurosurgery at the University of Texas Health Science Center San Antonio. The data highlights the continued favorable safety profile and encouraging efficacy results of Rhenium (186Re) Obisbemeda in a patient population with historically poor prognosis. ReSPECT-GBM is a first-in-human, open-label, Phase 1/2 study investigating feasibility, dose escalation, and critical convection enhanced delivery (CED) parameters to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and potential efficacy of Rhenium (186Re) Obisbemeda in recurrent adult glioma (IND 116117). Key Highlights from the ReSPECT-GBM Phase 1/2 Trial Update: 42 total patients have enrolled thus far at 3 sites and with 19/42 patients having been treated to date at the recommended Phase 2 dose (22.3 mCi in 8.8 mL) in tumors of approximately 20 cm3 or less. All Phase 2 patients have recurrent, histologically confirmed glioblastoma; 1 recurrence, bevacizumab naïve, single tumor of approximately 20 cm3 or less (small-to-medium sized tumors). Average tumor size in Phase 2 was 7.5 mL (range 0.9-22.8 mL). Increases in absorbed dose correlated with specific drug delivery parameters such as infused dose and volume, maximal convection flow rate, and number of catheters. Rhenium (186Re) Obisbemeda continues to show a favorable safety profile in the 42 enrolled patients; one dose-limiting toxicity (hemiplegia) has been reported, which was observed in Cohort 8 (41.5 mCi and 16.3 mL). In Phase 2, most adverse events (AEs) were mild (73.5%) or moderate (18.8%), and largely unrelated (37.7%), or unlikely related (27.1%) to the drug. Of the 9 severe adverse events (SAEs), only 2 were related to the study drug. Average absorbed radiation dose to the tumor in Phase 2 was 300 Gy (n=18, 1 patient still under analysis). To date, 88.9% of Phase 2 patients met key CED drug delivery parameters shown to correlate with overall survival, achieving a tumor absorbed dose >100 Gy and radiation coverage of >70%. 29/42 patients treated thus far participated in the Phase 1 dose escalation phase of the trial (Note: as per protocol, 6/42 patients were included in both the Phase 1 and Phase 2 trial arms and related analyses). Phase 1 dose-escalation increased administered doses from 1.0 mCi to 41.5 mCi and volumes from 0.66 mL to 16.3 mL. In terms of objective tumor response based on quantitative image analysis, a statistically significant reduction in tumor volume rate change was seen in tumors receiving > 100 Gy absorbed dose (n=11 patients analyzed to date, p<0.005). Sufficient tumor coverage correlated with tumor control, while regrowth occurred outside treated areas. Tillkännagivande • Sep 09
Plus Therapeutics, Inc. Provides Non-Compliance Update As previously disclosed, on March 8, 2024, Plus Therapeutics, Inc. (the Company") received a written notice (the Notice") from the Listing Qualifications staff of The Nasdaq Stock Market (Nasdaq") notifying the Company that it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders' equity (the Minimum Stockholders' Equity Requirement") for continued listing on The Nasdaq Capital Market or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the Alternative Standards"). The Notice stated that the Company's Form 10-K for the year ended December 31, 2023, disclosed stockholders' equity of ($1,348,000) as of December 31, 2023, and that, as of March 8, 2024, the Company did not meet the Alternative Standards. As required by Nasdaq, the Company submitted its plan to regain compliance with the Minimum Stockholders' Equity Requirement on April 22, 2024. On September 5, 2024, the Company received a letter from Nasdaq (the Letter") notifying the Company that it had not regained compliance with Nasdaq Listing Rule 5550(b)(1) and that, as a result, unless the Company timely requests an appeal of this determination to a Nasdaq Hearings Panel, Nasdaq would move to suspend trading of the Company's common stock and to have the Company's shares of common stock, par value $0.001 per share, delisted from The Nasdaq Capital Market. Accordingly, the Company intends to timely appeal the determination, which will automatically stay any suspension or delisting action pending the Hearings Panel's decision and the expiration of any additional extension period granted by the Hearings Panel following the hearing. As a result, the Company's shares of common stock is expected to remain listed on The Nasdaq Capital Market through at least that time. There can be no assurance, however, that the Hearings Panel will grant the Company's request for continued listing or that the Company will be able to demonstrate compliance with Nasdaq Listing Rule 5550(b)(1) within any additional compliance period that may be granted by the Hearings Panel. Reported Earnings • Aug 16
Second quarter 2024 earnings released: US$0.45 loss per share (vs US$0.59 loss in 2Q 2023) Second quarter 2024 results: US$0.45 loss per share. Revenue: US$1.28m (down 31% from 2Q 2023). Net loss: US$2.94m (loss widened 98% from 2Q 2023). Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Tillkännagivande • Aug 08
Plus Therapeutics, Inc. to Report Q2, 2024 Results on Aug 14, 2024 Plus Therapeutics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 14, 2024 Tillkännagivande • Jun 10
Plus Therapeutics, Inc. Receives the Resignation of Dr. Norman Lafrance, Its Chief Medical Officer, Effective June 12, 2024 On June 5, 2024, Plus Therapeutics, Inc. received the resignation of Dr. Norman LaFrance, its Chief Medical Officer. Dr. LaFrance’s resignation is effective June 12, 2024. New Risk • Jun 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-US$4.8m). Shareholders have been substantially diluted in the past year (129% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$45m net loss in 3 years). Market cap is less than US$100m (€13.6m market cap, or US$14.8m). Tillkännagivande • May 22
Plus Therapeutics, Inc., Annual General Meeting, Aug 15, 2024 Plus Therapeutics, Inc., Annual General Meeting, Aug 15, 2024, at 09:00 US Eastern Standard Time. Reported Earnings • May 17
First quarter 2024 earnings released: US$0.76 loss per share (vs US$2.07 loss in 1Q 2023) First quarter 2024 results: US$0.76 loss per share (improved from US$2.07 loss in 1Q 2023). Revenue: US$1.68m (up 231% from 1Q 2023). Net loss: US$3.26m (loss narrowed 32% from 1Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. Tillkännagivande • May 15
Plus Therapeutics, Inc. to Report Q1, 2024 Results on May 15, 2024 Plus Therapeutics, Inc. announced that they will report Q1, 2024 results After-Market on May 15, 2024 New Risk • May 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$1.3m). Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Market cap is less than US$10m (€8.57m market cap, or US$9.24m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$53m net loss in 3 years). Share price has been volatile over the past 3 months (9.1% average weekly change). Revenue is less than US$5m (US$4.9m revenue). Tillkännagivande • May 07
Plus Therapeutics, Inc. announced that it expects to receive $17.948504 million in funding from Aigh Capital Management, LLC Plus Therapeutics, Inc. announced that it has entered into a securities purchase agreement with new institutional investors and Company insiders to issue up to an aggregate of 3,238,627 shares of its common stock at an issue price of $2.022 per share for the gross proceeds of $6,548,503.794; Series A warrants to purchase up to an aggregate of 3,238,627 shares of common stock at an exercise price of $1.772 per share for an aggregate gross proceeds of up to $5,738,847.044 and Series B warrants to purchase up to 3,238,627 shares of common stock at an exercise price of $1.772 per share for an aggregate of up to approximately $5,738,847.044 for the aggregate gross proceeds of $17,948,503.794 on May 6, 2024. The Series B warrants will be exercisable until the one-year anniversary of the effectiveness of a registration statement covering the resale of shares of common stock underlying the Series B warrants. The private placement is expected to close on or about May 8, 2024, subject to satisfaction of customary closing conditions. Tillkännagivande • Apr 23
Plus Therapeutics, Inc. Receives $3 Million Award Recommendation from the United States Department of Defense Plus Therapeutics, Inc. announced it has been selected for funding by the Department of Defense (DoD) office of the Congressionally Directed Medical Research Programs (CDMRP). The award is expected to commence in Third Quarter 2024 and will support the planned expansion of the Company’s clinical trial for pediatric brain cancer. The DoD Peer Reviewed Cancer Research Program (PRCRP) Advancing Cancer Care through Clinical Trials Award will be utilized to fund a Phase 1 dose escalation trial to address the fiscal year 2023 PRCRP Topic Area of Pediatric Brain Tumors. This study will investigate a novel therapeutic, Rhenium (186Re) Obisbemeda (186RNL), delivered by Convection Enhanced Delivery (CED), for the treatment of supratentorial recurrent, refractory, or progressive pediatric high-grade glioma (HGG) and ependymoma. It is expected to begin enrollment in the second half of 2024. Tillkännagivande • Mar 27
Plus Therapeutics, Inc. Announces Validation & Clinical Implementation of Csf-01 Leptomeningeal Cancer Cell Diagnostic Plus Therapeutics, Inc. announced it has successfully completed key validation testing and implementation of its tumor cell enumeration assay, known as CSF-01, to be used initially as an exploratory endpoint in its ReSPECT-LM clinical trials. Plus’ CSF-01 cancer cell enumeration test is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in the trial’s early cohorts. In Phase 1/Part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM. On December 12, 2023, Plus announced its partnership with K2bio (Houston, Texas) to implement Plus’ CSF-01 diagnostic for LM cancers in the ReSPECT-LM trials. While validated for use in Plus’ clinical development programs, full Clinical Laboratory Improvement Amendments (CLIA) certification is not anticipated until 2025. The ReSPECT-LM trial, including support for CSF-01 testing, is currently receiving grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT). The FORSEE trial was performed by the original developer and licensor of CSF-01 and is a multi-center, prospective clinical trial enrolling patients with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed LM. If the FORSEE data is positive, the company intend to work toward increasing commercial reimbursement for the CLIA-certified test and explore partnerships to maximize diagnostic utilization for the broader CNS cancer space. 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 a 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 Rhenium (186Re) obisbemeda: Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver directly targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda 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. Rhenium (186Re) obisbemeda 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). Tillkännagivande • Mar 15
Plus Therapeutics Receives Non-Compliance Update from Nasdaq On March 8, 2024, Plus Therapeutics, Inc. (the Company") received a letter (the Notice") from the Listing Qualifications staff of The Nasdaq Stock Market (Nasdaq") notifying the Company that it no longer complies with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders' equity for continued listing on the Nasdaq Capital Market (the Equity Standard") or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the Alternative Standards"). The Notice states that the Company's Form 10-K for the year ended December 31, 2023, disclosed stockholders' equity of ($1,348,000) as of December 31, 2023, and that, as of March 8, 2024, the Company did not meet the Alternative Standards. The Notice has no immediate effect on the Company's listing on the Nasdaq Capital Market. Nasdaq is providing the Company 45 calendar days from the date of the Notice, or until April 22, 2024, to submit a plan to regain compliance with the Equity Standard (the Compliance Plan"). If the Compliance Plan is accepted, Nasdaq may grant the Company an extension of up to 180 calendar days from the date of the Notice, or until September 4, 2024, to regain compliance with the Equity Standard. If the Company does not timely submit a Compliance Plan or if such plan is not accepted, or if it is accepted and the Company does not regain compliance in the required timeframe, Nasdaq could provide notice that the Company's common stock is subject to delisting. The Company plans to timely submit a Compliance Plan, is evaluating its options for complying with the Equity Standard or the Alternatives Standards, including pursuing additional capital raising opportunities, and will continue to monitor its stockholders' equity. However, there can be no assurance that the Company will be able to regain or maintain compliance with the Equity Standard or the Alternatives Standards. Tillkännagivande • Mar 11
Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases Plus Therapeutics, Inc. announced it has completed dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. Three patients were dosed as part of Cohort 5, bringing the total to 18 patients dosed in the ReSPECT-LM trial to date. The Company plans to initiate dosing in Cohort 6 in the second quarter of 2024, pending Data Safety Monitoring Board (DSMB) approval. In addition, five new clinical trial sites were added to this trial over the last year, bringing the total number of sites to seven. The Company anticipates that this will allow for continued maximal enrollment allowed under the protocol. The FDA has granted Fast Track designation to rhenium (186Re") obisbemeda for LM and Orphan Drug Designation for the treatment of breast cancer with LM, and the ReSPECT-LM program continues to be funded in part by a 3-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Reported Earnings • Mar 06
Full year 2023 earnings released: US$4.24 loss per share (vs US$11.58 loss in FY 2022) Full year 2023 results: US$4.24 loss per share (improved from US$11.58 loss in FY 2022). Revenue: US$4.91m (up US$4.69m from FY 2022). Net loss: US$13.3m (loss narrowed 34% from FY 2022). Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 12% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings. Tillkännagivande • Feb 28
Plus Therapeutics, Inc. to Report Q4, 2023 Results on Mar 05, 2024 Plus Therapeutics, Inc. announced that they will report Q4, 2023 results After-Market on Mar 05, 2024 Board Change • Dec 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 10 experienced directors. 2 highly experienced directors. Member of Scientific Advisory Board Andrew Brenner was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Tillkännagivande • Nov 24
Plus Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $15.9375 million. Plus Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $15.9375 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Tillkännagivande • Nov 21
Plus Therapeutics, Inc. Reports New Interim ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting Plus Therapeutics, Inc. announced positive data from the ongoing ReSPECT-GBM Phase 2 trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) at the Society for NeuroOncology (SNO) 28th Annual Meeting held November 15-19, 2023 in Vancouver, Canada. Key Highlights from the ReSPECT-GBM Phase 2 Trial: ReSPECT-GBM is an ongoing, first-in-human, open-label, Phase 1/2 study investigating dose escalation and other delivery parameters (i.e., number of catheters (1-5), infusion rates, drug volumes, and drug concentrations) to determine the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety, and efficacy of rhenium (186Re) obisbemeda in recurrent adult glioma (IND 116117). The primary objective of the Phase 2 study is to assess overall survival (OS) following rhenium (186Re) obisbemeda administration. As of November 14, 2023, 15 patients with rGBM have been treated with rhenium (186Re) obisbemeda at a dose of 22.3 mCi delivered directly to the tumor by Convection Enhanced Delivery (CED). In 15 treated patients, mOS is 13 months (95% CI 5 months). Currently, 9 out of the 15 treated patients remain alive. Median PFS is 11 months (95% CI 6-11 months). The average percent of treated tumor across all 15 patients was 87.2% at 120 hours, with 13/15 patients receiving greater than or equal 70% tumor volume coverage by the drug and =100 Gy absorbed dose to the tumor. Advanced longitudinal imaging analysis supports the observed efficacy signal of rhenium (186Re) obisbemeda. Rhenium (186Re) obisbemeda continues to be generally safe and well tolerated, consistent with data accumulated in the Phase 1 trial. New Risk • Nov 05
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 102% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (102% increase in shares outstanding). Market cap is less than US$10m (€6.75m market cap, or US$7.24m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Revenue is less than US$5m (US$3.8m revenue). Tillkännagivande • Nov 01
Plus Therapeutics, Inc. (NasdaqCM:PSTV) announces an Equity Buyback for $0.5 million worth of its shares. Plus Therapeutics, Inc. (NasdaqCM:PSTV) announces a share repurchase program. Under the program, the company will repurchase up to $0.5 million worth of its outstanding common stock. The company will fund repurchases with available cash. The repurchase will be valid for 12 months. Tillkännagivande • Oct 24
Plus Therapeutics, Inc. to Report Q3, 2023 Results on Oct 31, 2023 Plus Therapeutics, Inc. announced that they will report Q3, 2023 results at 4:00 PM, US Eastern Standard Time on Oct 31, 2023 Tillkännagivande • Oct 11
Plus Therapeutics, Inc. Completes Dosing in Cohort 4 of ReSPECT-LM Phase 1 Clinical Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases Plus Therapeutics, Inc. announced it has completed dosing in Cohort 4 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. In addition, the Company has completed the transfer of proprietary materials, protocols, and equipment from Biocept under the terms of the recently announced expanded agreement for CNSide, a cerebrospinal fluid (CSF)-based tumor cell capture and enumeration assay being utilized in the ReSPECT-LM clinical trial. Phase 1, Part A of the ReSPECT-LM trial (Cohorts 1-3) is complete and demonstrated an average 53% reduction in CNSide tumor cell counts at Day 28 post-treatment in 10 patients receiving a single administration of rhenium (186Re) obisbemeda. The FDA has approved continued dose escalation and expansion into Part B (Cohorts 4-7). Completion of dosing in Cohort 4 was the fastest enrollment of all the Cohorts to date. There have been no observed dose limiting toxicities with radiation doses of up to 44.10 millicuries. The Company plans to initiate dosing in Cohort 5 this quarter, pending Data Safety Monitoring Board (DSMB) approval. After the update at the SNO meeting in November, the Company anticipates additional data releases in 2024. The CNSide assay has potential as: an LM diagnostic assay, a surrogate endpoint in clinical trials for CNS cancers such as LM, and as a disease monitoring biomarker assay in the management of patients undergoing radiotherapy for LM. The acquired materials and protocols from Biocept help ensure Plus’ access to the CNSide assay in the ongoing ReSPECT-LM Phase 1 clinical trial with rhenium (186Re) obisbemeda. Plus Therapeutics retains its option, solely at the Company’s discretion, to acquire an exclusive field of use license on the CNSide assay in return for a $1.0 million payment, if exercised prior to January 1, 2025. The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM, and the ReSPECT-LM Phase 1 program continues to be funded in part by a 3-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Tillkännagivande • Sep 06
Plus Therapeutics, Inc. Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastase Plus Therapeutics, Inc. announced treatment of the first patient in Part B (Cohort 4) of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors. The maximum total radiation activity administered in Phase 1/Part A was 26.4 millicuries (mCi). In Phase 1/Part B the maximum administered total radiation activity will be 110.0 mCi in cohort 7. Positive data from Part A (Cohorts 1-3) of the ReSPECT-LM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of LM were presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference in August 2023. In summary, the findings in the Phase 1/Part A showed: Ten patients were treated with a maximum absorbed dose of 85 Gray (Gy) and up to 26.4 mCi of radiation activity. No dose limiting toxicities have been observed and a maximum tolerated dose or maximum feasible dose has not been reached in Part A. Cerebrospinal fluid (CSF) tumor cell counts, evaluated using a molecular diagnostic assay, decreased an average of 53% measured at 28 days post-treatment. In addition, five of the 10 treated patients in Part A remain alive with a median overall survival of 10 months. The FDA has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM. The ReSPECT-LM clinical trial is funded, in part, by a 3-year, $17.6 million grant by the Cancer Prevention & Research Institute of Texas. 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. Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to directly deliver targeted high-dose radiation in CNS tumors in a safe, effective, and convenient administration. Rhenium (186Re) obisbemeda has the potential to reduce 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. Rhenium (186Re) obisbemeda 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). Tillkännagivande • Aug 09
Plus Therapeutics, Inc. to Report Q2, 2023 Results on Aug 14, 2023 Plus Therapeutics, Inc. announced that they will report Q2, 2023 results at 4:00 PM, US Eastern Standard Time on Aug 14, 2023 Tillkännagivande • Jul 28
Plus Therapeutics, Inc. Appoints Pius Maliakal as Vice President of Clinical Operations Plus Therapeutics, Inc. announced the appointment of Pius Maliakal, M. Pharm., Ph.D., as Vice President of Clinical Operations. Dr. Maliakal will be responsible for the strategy and planning of key clinical operational initiatives, focusing on advancing the Companys lead clinical trials, ReSPECT-GBM and ReSPECT-LM, and further developing the broader pipeline. Dr. Maliakal is an accomplished R&D professional who brings over 20 years of global and domestic experience to Plus Therapeutics. Prior to joining the Company, he served as Director of Clinical Science at PTC Therapeutics, leading the clinical development, clinical trial operations, strategies, and data interpretations of all oncology assets across the enterprise. Previously, as Director of Clinical Development at Eagle Therapeutics, he led and facilitated the core design and conduct of Phase 1 and 2 clinical trials within breast cancer, lung cancer and other solid tumors. During his prior tenure at Immunomedics, he was instrumental in the Phase 1 through Phase 3 clinical trials of Trodelvy (sacituzumab govitecan) leading to accelerated FDA approval for treatment of triple-negative breast cancer as well as other investigational agents, including unesbulin and emvododstat. Dr. Maliakal earned his M. Pharm. from Nagpur University, India and his Ph.D. from the University of Otago, New Zealand. Tillkännagivande • Jun 30
Plus Therapeutics, Inc. Reports Positive Interim Updates from Two Respect Clinical Trials at SNMMI Annual Meeting Plus Therapeutics, Inc. reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium ( 186 Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM) and leptomeningeal metastases (LM) at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting, which took place June 24-27, 2023 in Chicago, Illinois. An oral presentation titled, Safety and Feasibility Results from a Phase 1/2 Clinical Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Recurrent Glioma: The ReSPECT-GBM Trial [P988], brief highlights include: Data from 21 patients in the Phase 1 trial used to support the recommended Phase 2 trial dose for patients with tumor volumes =20 mL was presented. A single dose of rhenium ( 186 Re) obisbemeda was generally safe and well-tolerated, with no dose-limiting toxicities and minimal systemic radiation exposure. The data demonstrates efficacy signals in a prognostically unfavorable patient population. The median overall survival (OS) in all 21 patients (including those receiving small radiation doses in early cohorts and five patients previously treated with Bevucizamab) was 11 months or a 38% increase in OS versus a median OS of approximately 8 months for standard of care in rGBM. Median OS in patients receiving >100 Gy of absorbed radiation dose was 76 weeks (17 months) versus 22 weeks (6 months) for those receiving <100 Gy (p=0.0002). Increased absorbed radiation dose and percent tumor volume treated correlates with improvement in overall survival, specifically: For each 100 Gy increase of Total Dose in Distribution Volume, the risk of death decreases by 45.6% (p=0.003). For each 10% increase in the Ratio of Treated to Total Tumor Volume, the risk of death decreases by 66.9% (p=0.002). A poster presentation titled, Preliminary Clinical Data in The Phase 1/2a Dose Escalation Trial of 186RNL (Rhenium-186 Nanoliposome) (186Re) Obisbemeda in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial [P978], includes data that showed: Interim results from 10 patients in the Phase 1 trial show a single treatment with rhenium (186Re) obisbemeda decreased cerebrospinal fluid (CSF) tumor cell count and was well-tolerated in patients with LM. Rhenium ( 186 Re) obisbemeda doses administered through an intraventricular catheter (Ommaya reservoir) showed prompt, complete and durable distribution throughout the CSF through Day 7. A single rhenium ( 186 Re) obisbemeda administered dose between 6.6 mCi and 26.4 mCi achieved absorbed doses of up to 88.98 Gy to the ventricles and cranial subarachnoid space. No dose limiting toxicities were observed and safety observations were generally minor and resolved. Phase 1/Part B, for continued dose escalation (Cohorts 4-7), will open following review by the U.S. Food and Drug Administration, and repeated dosing will be explored. An expansion in Cohort 3 is currently enrolling eligible patients. A full update will be provided at the SNO/ASCO CNS Cancer Conference in August 10-12, 2023. Tillkännagivande • Feb 15
Plus Therapeutics, Inc. to Report Q4, 2022 Results on Feb 23, 2023 Plus Therapeutics, Inc. announced that they will report Q4, 2022 results After-Market on Feb 23, 2023 Tillkännagivande • Feb 02
Plus Therapeutics, Inc. Completes Enrollment in Second ReSPECT-LM Phase 1 Trial Cohort of Rhenium (186Re) Obisbemeda for the Treatment of Leptomeningeal Metastases Plus Therapeutics, Inc. announced completion of enrollment in Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM). At the 2022 Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), Plus Therapeuticspresented Phase 1 data from the ReSPECT-LM trial demonstrating that a single administered dose of rhenium (186Re) obisbemeda was feasible, safe and well-tolerated across two dosages in four patients from Cohorts 1 and 2, with patients experiencing a decreased cerebrospinal fluid tumor cell count at 48 hours following treatment of 46% to 92%. The ReSPECT-LM trial (NCT05034497) is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design. It will evaluate the maximum tolerated dose, maximum feasible dose, safety and efficacy of a single administration of rhenium (186Re) obisbemeda via intraventricular catheter for LM following standard surgical, radiation and/or chemotherapy treatment. The primary endpoints of the study are the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. The U.S. Food and Drug Administration has granted Fast Track designation to rhenium (186Re) obisbemeda for the treatment of LM. ReSPECT-LM is funded by a three-year $17.6 million grant by the Cancer Prevention & Research Institute of Texas (CPRIT). Tillkännagivande • Jan 19
Plus Therapeutics Announces First Patient Dosed in ReSPECT-GBM Phase 2b Trial of Rhenium (186Re) Obisbemeda for Treatment of Recurrent Glioblastoma Plus Therapeutics, Inc. announced that the first patient has been dosed in the ReSPECT-GBM Phase 2b dose expansion clinical trial evaluating rhenium (186Re) obisbemeda for the treatment of recurrent glioblastoma (GBM). This Phase 2b multi-center trial is designed to evaluate the safety, tolerability, distribution and efficacy of rhenium (186Re) obisbemeda infused directly into the tumor via convection-enhanced delivery catheters in patients with recurrent GBM progressing after conventional treatment. The Phase 2b trial is expected to enroll up to 31 additional patients with small- to medium-sized tumors (20 mL or less) in approximately 24 months. The trial is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH). GBM affects approximately 14,490 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40.8% and a five-year survival rate of only 6.9%. There is no clear standard of care for recurrent GBM and even the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient’s life. Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver highly targeted high dose radiation in CNS tumors in a safe, effective and convenient manner to optimize patient outcomes. Rhenium (186Re) obisbemeda has the potential to reduce risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging. Tillkännagivande • Nov 29
Plus Therapeutics Receives Second Letter from Nasdaq Regarding Minimum Bid Price Requirement As previously reported, on May 24, 2022, Plus Therapeutics, Inc. (the “Company”) received written notice (the “Notification Letter”) from the Listings Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that because the closing bid price for the Company’s common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complied with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Requirement”). The Notification Letter stated that the Company had 180 days, or until November 21, 2022, to demonstrate its compliance with the Minimum Bid Requirement. On November 22, 2022, the Company received a second letter from Nasdaq advising that the Company had been granted an additional 180 calendar days, or to May 22, 2023, to regain compliance with the Minimum Bid Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A). The Company intends to continue to actively monitor the closing bid price of its common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. Specifically, the Company has confirmed to Nasdaq that, if necessary, it will implement a reverse stock split of its outstanding common stock (if approved by the Company’s stockholders) to attempt to regain compliance. If the Company does not regain compliance within the additional compliance period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Requirement during the 180-day additional compliance period or maintain compliance with the other Nasdaq listing requirements. Tillkännagivande • Nov 20
Plus Therapeutics Provides Updates on ReSPECT™ Clinical Trials Plus Therapeutics, Inc. presented data from two ongoing clinical trials evaluating the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, in recurrent glioblastoma (GBM), leptomeningeal metastases (LM), as well as clinical trial plans for pediatric brain cancer at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO). The oral presentation titled, Report of the ReSPECT-GBM Phase 1/2a Dose Escalation Trial of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma via Convection Enhanced Delivery (CED) & Planned Phase 2b Trial [RADT-20], included the following key findings: In 24 patients with recurrent glioblastoma, a single dose of rhenium (186Re) obisbemeda was administered in the dose escalation phase, (range: 1.0 mCi/0.66 mL to 31.2 mCi/12.3 mL), achieving up to 740 Gray (Gy) of absorbed radiation dose to the tumor. Between one to four intracranial CED catheters have been placed in each patient and there have been no dose limiting toxicities and a good safety profile has been observed.A statistically significant improvement in overall survival correlated with both the average absorbed dose of radiation to the tumor and the percent volume of tumor treated, specifically: A 100 Gy increase in the absorbed dose correlated with a 35.7% decrease in the risk of death (p=0.003, Cox methods hazard ratios = 0.643). A 1% increase in tumor volume treated is associated with a 4.5% decrease in the risk of death (p=0.002, Cox methods hazard ratios = 0.955). A recommended Phase 2 dose of 22.3 mCi in 8.8 mL is being studied for tumor volumes of 20 mL or less and is expected to enroll up to an additional 31 patients. Continued dose escalation will be performed to assess the potential to treat tumors larger than 20 mL. The Company’s second oral presentation titled, Preclinical Data and Initial Clinical Experience in the Phase 1/2a Dose Escalation Trial of Rhenium-186 Nanoliposome (186RNL) in Leptomeningeal Metastases [LM]: the ReSPECT-LM Trial [CTNI-02], highlighted data from the first two cohorts which demonstrates the potential of rhenium (186Re) obisbemeda to treat LM: As single rhenium (186Re) obisbemeda dose administered through an intraventricular catheter (Ommaya reservoir) at 6.6 mCi in 5.0 mL in Cohort 1 achieved absorbed doses of 18.7 to 29.0 Gy to the ventricles and cranial subarachnoid space, which was well tolerated with no treatment-related adverse events of greater than grade 1. All four patients treated to date in Cohorts 1 and 2 were observed to have prompt and complete rhenium (186Re) obisbemeda distribution throughout the cerebrospinal fluid (CSF) subarachnoid space that was durable to 28 days. All patients showed a decreased CSF tumor cell count by microfluidic chamber assay after treatment, ranging from 46% to 92%. Board Change • Nov 16
High number of new and inexperienced directors There are 10 new directors who have joined the board in the last 3 years. The company's board is composed of: 10 new directors. No experienced directors. 2 highly experienced directors. President, CEO & Director Marc Hedrick is the most experienced director on the board, commencing their role in 2002. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Nov 03
Plus Therapeutics to Provide Update on Respect(Tm) Clinical Trials At the 27Th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology Plus Therapeutics, Inc. announced it will present data from two ongoing clinical trials evaluating the Company's lead investigational targeted radiotherapeutic, rhenium ((186) Re) obisbemeda, in recurrent glioblastoma, leptomeningeal metastases, as well as clinical trial plans for pediatric brain cancer at the 27(th) Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) being held November 16-20, 2022 at the Tampa Convention Center in Tampa Bay, Florida. Tillkännagivande • Oct 27
Plus Therapeutics, Inc. Announces Selection of Rhenium (186Re) Obisbemeda as International Non-Proprietary Name for 186RNL Plus Therapeutics, Inc. (the Company) announced that the World Health Organization's (WHO) International Non-proprietary Name (INN) Expert Committee has selected the non-proprietary name Rhenium ((186) Re) obisbemeda for the Company's lead investigational targeted radiotherapeutic, formerly known as (186) RNL. Going forward, Plus Therapeutics will use Rhenium ((186) Re) obisbemeda in place of (186) RNL. The assignment of Rhenium ((186) Re) obisbemeda as the recommended INN for (186) RNL is another important milestone in the ongoing development of lead targeted radiotherapeutic as plan to move it towards mid- and late-stage clinical development, including a planned Phase 2 trial in patients with recurrent glioblastoma by the end of 2022. Tillkännagivande • Oct 07
Plus Therapeutics, Inc. to Report Q3, 2022 Results on Oct 20, 2022 Plus Therapeutics, Inc. announced that they will report Q3, 2022 results After-Market on Oct 20, 2022 Tillkännagivande • Sep 23
Plus Therapeutics, Inc. Receives Product Development Research Grant by the Cancer Prevention and Research Institute of Texas Plus Therapeutics, Inc. announced on August 17, 2022, that it was awarded a $17.6 million Product Development Research grant by the Cancer Prevention and Research Institute of Texas to fund the continued development of the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome, for the treatment of patients with leptomeningeal metastases. On September 19, 2022, the Company entered into a Cancer Research Grant Contract effective as of August 31, 2022, with CPRIT, pursuant to which CPRIT will provide the Company with the $17.6 million CPRIT Grant funding over a three-year period. The CPRIT Grant is subject to customary CPRIT funding conditions, including, but not limited to, (a) a matching fund requirement (one dollar for every two dollars awarded by CPRIT), (b) revenue sharing obligations upon commercialization of 186RNL based on specific dollar thresholds until CPRIT receives the aggregate amount of 400% of the proceeds awarded under the CPRIT Grant, and (c) certain reporting requirements. The CPRIT Contract will terminate on August 30, 2025, unless terminated earlier by (a) the mutual written consent of all parties to the CPRIT Contract, (b) CPRIT for an event of default by the Company, (c) CPRIT, if the funds allocated to the CPRIT Grant become legally unavailable during the term of the CPRIT Contract and CPRIT is unable to obtain additional funds for such purposes, and (d) the Company for convenience. CPRIT may require the Company to repay some or all of the disbursed CPRIT Grant proceeds (with interest not to exceed 5% annually) in the event of the early termination of the CPRIT Contract by CPRIT for an event of default by the Company or by the Company for convenience. Tillkännagivande • Sep 13
Plus Therapeutics Presents Positive Phase 1 Data from ReSPECT-GBM Clinical Trial at the European Society for Medical Oncology Congress 2022 Plus Therapeutics, Inc. announced Phase 1 data from the ReSPECT-GBM Phase 1/2a dose escalation clinical trial evaluating the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), in recurrent glioblastoma (GBM) in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022, being held September 9-13, 2022 in Paris, France. The oral presentation titled, The ReSPECT-GBM Phase 1/2a Dose Escalation Trial of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma via Convection Enhanced Delivery (CED) & Planned Phase 2b Trial, reviews data from the Phase 1 ReSPECT-GBM trial which evaluated 23 adult patients with recurrent GBM across 8 cohorts of increasing dose and treated over a seven-year period. Key findings include: No dose-limiting toxicities (DLT) have been observed and the procedure is very well tolerated with a strong safety profile. Minimal systemic radiation has been observed and the majority of adverse events have been mild or moderate and considered causally unrelated to the procedure. Improved median overall survival (OS) rates correlated with the absorbed tumor radiation dose. When patients were stratified based on receipt of either a therapeutic or a subtherapeutic absorbed dose of radiation to the tumor, a statistically significant improvement in survival was observed. Specifically, patients receiving a therapeutic absorbed radiation dose (>100 Gray) had a median OS of 22.9 (95% CI of 8.8-42.3) months compared to those receiving a subtherapeutic absorbed radiation dose (<100 Gray) whose median OS was 5.6 months (95% CI of 1.6-9.4). Currently, three patients remain alive, all in the therapeutic group. Feasibility to deliver up to at least 20 times more radiation to the tumor than the standard of care, external beam radiation therapy (EBRT). A maximum of 32.2 mCi in 12.3 mL of volume has been delivered in and near the tumors, and a maximum average absorbed dose of radiation of 740 Gray has been successfully administered in a single procedure. Average absorbed radiation dose to the tumor increased in latter dosing cohorts with greater administered doses of Re-186 ß-particle radiation, larger drug convection enhanced delivery (CED) infusate volumes, more catheters used (up to 4 versus 1), and higher convection flow rates. In cohorts 5 and later, 82% of patients received a therapeutic radiation dose of >100Gray. Single-photon emission computerized tomography and (SPECT)/CT scanning were used during treatment to compute tumor coverage and dosimetry. Post treatment imaging analyses, including MRI, relative cerebral blood volume (rCBV) analysis and treatment response assessment maps (TRAMs) correlated with a positive tumor response and confirmed the presence of pseudoprogression in patients with positive tumor responses. ReSPECT-GBM will proceed to an NIH and U.S. Food and Drug Administration (FDA) approved Phase 2 trial in the U.S. at the current non-DLT 186RNL dose and will expand exploring higher radiation doses in larger volumes to treat larger tumors. Additionally, two or more 186RNL administrations, if indicated, will be evaluated and reviewed with the FDA, as well as expanded safety, imaging and efficacy data to support a planned future registrational trial. Tillkännagivande • Aug 30
Plus Therapeutics, Inc. Announces Summary of FDA Meeting Plus Therapeutics, Inc. announced an update following receipt of formal minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA) specific to Chemistry, Manufacturing and Controls (CMC). The meeting focused on the Company’s Current Good Manufacturing Practice (cGMP) clinical and commercial manufacturing process for its lead investigational targeted radiotherapeutic, BMEDA-chelated Rhenium-186 NanoLiposome (186RNL), for recurrent glioblastoma (GBM). The FDA indicated agreement with the Company’s proposed application of cGMP guidance for radiotherapeutics, small molecule drug products and liposome drug products for Plus Therapeutics’ novel 186RNL in support of ongoing and future glioblastoma clinical trials, manufacturing scale up and commercialization. Alignment with the FDA includes support of the Company’s proposed controls and release strategy for the new drug substance and new drug product. The Company expects that this FDA feedback will apply to 186RNL used in other clinical development programs, including leptomeningeal metastases and pediatric brain cancer. Tillkännagivande • Aug 16
Plus Therapeutics, Inc. (NasdaqCM:PSTV) announces an Equity Buyback for $2 million worth of its shares. Plus Therapeutics, Inc. (NasdaqCM:PSTV) announces a share repurchase program. Under the program, the company will repurchase up to $2 million worth of its outstanding common stock. The company intends to fund any share repurchases with available cash. The repurchase will be valid for 12 months. Tillkännagivande • Aug 14
Plus Therapeutics, Inc. Presents Positive Data from Ongoing ReSPECT™ Clinical Trials at the Annual Conference on CNS Clinical Trials and Brain Metastases Plus Therapeutics, Inc. presented positive data from two ongoing clinical trials of its lead investigational drug, Rhenium-186 Nanoliposome (186RNL), in the treatment of recurrent glioblastoma (GBM) and leptomeningeal metastases (LM) at the 2022 Annual Conference on CNS Clinical Trials and Brain Metastases. The conference is co-sponsored by the Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO) and is being held August 12-13, 2022 in Toronto, Canada. The oral presentation, titled Safety and Feasibility of Rhenium-186 Nanoliposome (186RNL) in Leptomeningeal Metastases Phase 1/2a Dose Escalation Trial [LOCL-04], demonstrated that the 186RNL dose administered through an intraventricular catheter at 6.6 mCi in 5.0 mL achieved absorbed doses of 18.7 to 29.0 Gy to the ventricles and cranial subarachnoid space, which was well tolerated with no treatment-related adverse events of greater than grade 1. Furthermore, all three patients in the cohort were observed to have prompt and complete 186RNL distribution throughout the cerebrospinal fluid (CSF) subarachnoid space that was durable past one week and very well tolerated. Importantly, all patients showed a decreased CSF cell count by microfluidic chamber assay after treatment, ranging from 65% to 92% which was also durable. Dr. Brenner also presented a poster titled, Safety and Feasibility of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma: the ReSPECT™ Phase 1 Trial [LOCL-08], which demonstrated that in 23 subjects with recurrent GBM receiving a single administration of 186RNL, significant overall survival benefits were observed in those achieving an average absorbed radiation dose greater than 100 Gy to the tumor compared to those with less absorption. These findings suggest a correlation in increasing convected drug volume and radiation dose with improvement in overall survival of patients and to date, 80% of patients in cohorts 5-7 met the threshold of high levels of absorption greater than 100 Gy. Data show 186RNL treatment is safe and well-tolerated, with no adverse events (AEs) with outcome of death or discontinuations. At the time of the presentation, four patients remain alive. Cohort 7 of the trial, with an increased dose of 186RNL (31.2 mCi and infusate volume 12.3 mL), is currently enrolling. Tillkännagivande • Jul 14
Plus Therapeutics, Inc. to Report Q2, 2022 Results on Jul 21, 2022 Plus Therapeutics, Inc. announced that they will report Q2, 2022 results at 4:00 PM, US Eastern Standard Time on Jul 21, 2022 Tillkännagivande • Jun 17
Plus Therapeutics Completes Enrollment of Cohort 1 Respect-Lm Phase 1/2A Trial Plus Therapeutics, Inc. announced the completion of enrollment in the first cohort of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of Rhenium-186 NanoLiposome ((186) RNL) for the treatment of leptomeningeal metastases. The investigational drug, (186) RNL, is a proprietary nanoscale compound with a unique chelated radioisotope that is administered locally as a single dose via a conventional Ommaya reservoir. Rhenium-186 is a dual energy emitter (beta and gamma) with a short average path length for high precision, low dose rate that is safer for normal tissues, and high radiation density that overwhelms innate DNA repair mechanisms. The dual energy emission allows real time evaluation and monitoring of the (186) RNL administration. The ReSPECT-LM trial (NCT05034497) is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1/2a study using a modified Fibonacci 3+3 study design. It will evaluate the maximum tolerated dose (MTD), maximum feasible dose (MFD), safety and efficacy of a single administration of (186) RNL via intraventricular catheter for LM following standard surgical, radiation and/or chemotherapy treatment. The primary endpoints of the study are the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration of response, progression free survival and overall survival. The ReSPECT-LM Phase 1/2a clinical trial follows preclinical studies in which tolerance to doses of (186) RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in two animal models of LM. In November 2021, the Company announced that the FDA granted Fast Track designation to (186) RNL for the treatment of LM. Fast Track designation confers several benefits to the drug development program including more frequent meetings with and written communication from FDA, eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, and Rolling Review, which allows a drug company to submit completed sections of its New Drug Application (NDA) for review by FDA, rather than wait until every section of the NDA is completed before the entire application can be reviewed. Tillkännagivande • Jun 14
Plus Therapeutics Reports Positive Clinical Outcomes from ReSPECT-GBM Trial at the Society of Nuclear Medicine and Molecular Imaging 2022 Annual Meeting Plus Therapeutics, Inc. announced it will present positive data on its lead investigational drug, Rhenium-186 NanoLiposome (186RNL), from the Phase 1/2a ReSPECT™-GBM dose escalation clinical trial in patients with recurrent glioblastoma (GBM) during an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting, on June 14 at 10:20 AM PT in Vancouver, British Columbia, Canada. According to the interim data, 186RNL delivered via convection enhanced delivery (CED) provides direct therapy with high radiation absorbed doses for local tumor control with minimal brain and whole-body radiation exposure. 186RNL’s tumor-killing effects were observed when greater than 100 Gy doses are delivered to greater than 80% of a tumor without dose-limiting toxicity. The presentation, titled “Rhenium-186-NanoLiposome (186RNL) in the treatment of relapse/recurrent glioblastoma (rGBM): a novel approach to cancer therapy,” outlines data from the ReSPECT-GBM trial, substantially funded by the U.S. National Institutes of Health/National Cancer Institute, which has thus far evaluated 24 adult patients with recurrent GBM across seven cohorts of increasing dose. To date, there have been no significant adverse events during the dose escalation. The company expects to initiate a Phase 2/registrational trial of 186RNL in patients with recurrent GBM by the end of 2022. In addition, the Company is continuing to evaluate 186RNL in leptomeningeal metastases as part of the ReSPECT-LM Phase 1/2a dose escalation clinical trial and is in late-stage planning for the treatment of pediatric ependymoma and high-grade GBM. Tillkännagivande • May 29
Plus Therapeutics Receives Non-Compliance Notice from the Nasdaq Stock Market On May 24, 2022, Plus Therapeutics, Inc. (the “Company”) received notice from The Nasdaq Stock Market LLC (“Nasdaq”) that, because the closing bid price for the Company’s common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Requirement”). Nasdaq’s notice has no immediate effect on the listing or trading of the Company’s common stock. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided an initial compliance period of 180 calendar days, or until November 21, 2022, to regain compliance with the Minimum Bid Requirement. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to November 21, 2022. If the Company does not achieve compliance with the Minimum Bid Requirement by November 21, 2022, the Company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, with the exception of the Minimum Bid Requirement, and provide written notice of its intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split if necessary. If the Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. In the event the Company receives notice that its common stock is being delisted, Nasdaq rules permit the Company to appeal any delisting determination by the Nasdaq staff. Board Change • Apr 27
High number of new and inexperienced directors There are 10 new directors who have joined the board in the last 3 years. The company's board is composed of: 10 new directors. No experienced directors. 2 highly experienced directors. President, CEO & Director Marc Hedrick is the most experienced director on the board, commencing their role in 2002. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Apr 15
Plus Therapeutics, Inc. to Report Q1, 2022 Results on Apr 21, 2022 Plus Therapeutics, Inc. announced that they will report Q1, 2022 results After-Market on Apr 21, 2022 Tillkännagivande • Apr 08
Plus Therapeutics, Inc., Annual General Meeting, May 16, 2022 Plus Therapeutics, Inc., Annual General Meeting, May 16, 2022, at 09:00 Central Standard Time. Agenda: To elect members of board of directors (the Board") for a one-year term; ratify the appointment of BDO USA, LLP as independent registered public accounting firm for the 2022 fiscal year; approve the issuance of shares of common stock to Lincoln Park pursuant to Nasdaq Listing Rules 5635(a), 5635(b) and 5635(d); approve the second amendment and restatement of the Company's 2020 Stock Incentive Plan; provide a non-binding advisory vote on the compensation of named executive officers; and transact such other business as may be properly brought before the meeting or any adjournment or postponement thereof. Tillkännagivande • Feb 19
Plus Therapeutics, Inc. to Report Q4, 2021 Results on Feb 24, 2022 Plus Therapeutics, Inc. announced that they will report Q4, 2021 results After-Market on Feb 24, 2022 Tillkännagivande • Jul 24
Plus Successfully Treats First Patient in Latest Dosing Cohort in ReSPECT-GBM Trial Plus Therapeutics, Inc. announced the first patient in the eighth cohort of the Phase 1 dose escalation ReSPECT-GBM clinical trial for recurrent glioblastoma (rGBM) has been successfully treated. The present cohort implements a 40% increase in volume (12.3 milliliters) and total radioactivity (31.2 millicuries) from the previous cohort. Twenty-two patients across eight dosing cohorts have been treated in the ReSPECT trial to date. Thus far, no treatment emergent dose-limiting toxicities have been observed, despite absorbed radiation doses to the tumor of up to 740 Gray. 
