AUSTIN, Texas, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (NASDAQ:PSTV) (the "Company" or "Plus Therapeutics"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today 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 intratheca ...

Core Insights - Plus Therapeutics, Inc. has appointed Russell Bradley as President and General Manager of its subsidiary CNSide Diagnostics, LLC, aiming to enhance its operations in the diagnostic landscape for CNS cancers [2][3] - The company has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, while Dr. Jonathan Stein has been named Medical Director [2][3] Company Developments - Russell Bradley brings over 30 years of leadership experience in diagnostics and life sciences, having held senior roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter, and is expected to make an immediate impact on CNSide [3] - The immediate priority for CNSide Diagnostics is to support early access and initial launch plans in the U.S. for its diagnostic tools targeting leptomeningeal disease [4] Product and Market Focus - CNSide Diagnostics develops proprietary laboratory-developed tests designed to identify tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [6] - The CNSide platform includes four laboratory-developed tests for treatment selection and monitoring of patients with leptomeningeal metastases, utilizing both cellular and molecular assays [7][8] - The CNSide CSF tumor cell enumeration LDT is currently being used in the ReSPECT-LM trial and is expected to be commercially available in 2025 [8] Industry Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in breast cancer patients [5] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need in the market [5]

Core Insights - Plus Therapeutics, Inc. has appointed Russell Bradley as President and General Manager of its subsidiary CNSide Diagnostics, LLC, aiming to enhance its operations in the diagnostic landscape for CNS cancers [2][3] - The company has also appointed Dr. Marc Hedrick, Mr. Rick Hawkins, and Mr. Russell Bradley to the CNSide Board of Directors, with Dr. Jonathan Stein as the new Medical Director [2][3] Company Developments - Russell Bradley brings over 30 years of experience in diagnostics and life sciences, having held senior roles at Abbott Laboratories, Luminex Corporation, and Beckman Coulter, and is expected to make an immediate impact on CNSide [3] - The immediate priority for CNSide Diagnostics is to support early access and initial launch plans in the U.S. for its diagnostic tools targeting leptomeningeal disease [4] Product and Market Focus - CNSide Diagnostics is focused on developing proprietary laboratory-developed tests to identify tumor cells that have metastasized to the central nervous system, particularly for patients with carcinomas and melanomas [6] - The CNSide platform includes four laboratory-developed tests for treatment selection and monitoring of patients with leptomeningeal metastases, utilizing both cellular and molecular assays [7][8] Industry Context - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, affecting approximately 5% of cancer patients, with a particularly high incidence in breast cancer patients [5] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need in this area [5]

Core Insights - Plus Therapeutics, Inc. has appointed Michael Rosol, Ph.D., as Chief Development Officer to lead clinical, pre-clinical, and biomarker development activities as the company transitions from mid-stage to pivotal trials in 2026 [1][2] - Dr. Rosol brings 25 years of experience in clinical trial design and operations, having previously served as Chief Medical Officer at Navidea Biopharmaceuticals and held key roles at Novartis Pharmaceuticals [2][3] - The company is focused on developing targeted radiotherapeutics for central nervous system cancers, specifically recurrent glioblastoma (GBM) and leptomeningeal metastases (LM), which currently lack FDA-approved therapies [5] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics aimed at enhancing clinical outcomes for patients with difficult-to-treat CNS cancers [5] - The company utilizes image-guided local beta radiation and targeted drug delivery approaches, with a pipeline that includes lead programs in recurrent GBM and LM [5] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [5] Disease Context - Leptomeningeal metastases (LM) occur in approximately 5% of cancer patients and are often terminal, with a one-year survival rate of only 7% [3] - Glioblastoma (GBM) affects around 15,000 patients annually in the U.S., with an average life expectancy of less than 24 months and a one-year survival rate of 40% [4] - There are currently no FDA-approved treatments for recurrent GBM that significantly extend patient life, highlighting a critical need for effective therapies [4]

Core Points - Plus Therapeutics, Inc. has closed a private placement financing of approximately $3.7 million and received a $2.0 million advance from CPRIT to support clinical development of Rhenium (Re) Obisbemeda for leptomeningeal metastases and the CNSide LM diagnostic test [1][8][12] Private Placement Financing - The private placement involved the issuance of secured convertible promissory notes totaling $3,362,251 and common stock purchase warrants for up to 3,002,009 shares at an exercise price of $1.12 per share [3][4] - The notes have a one-year maturity and are convertible into common stock at the investors' discretion [3][4] - The gross proceeds from the private placement were approximately $3.7 million before deducting offering expenses [5] CPRIT Funding Advance - The $2.0 million advance from CPRIT is part of a larger $17.6 million grant award, with approximately $5.2 million remaining after this advance [8][9] - This funding will accelerate the clinical development of Rhenium (Re) Obisbemeda and the CNSide LM diagnostic test [8] Company Strategy and Future Plans - The capital raised is expected to fully support the completion of two planned LM trials, positioning the company for a pivotal trial in 2026 [2] - The CNSide diagnostic test is planned for commercialization in the U.S. in 2025 [16][17] About Rhenium (Re) Obisbemeda - Rhenium (Re) Obisbemeda is a novel injectable radiotherapy aimed at treating CNS tumors, specifically recurrent glioblastoma and leptomeningeal metastases [13][18] - The treatment utilizes Rhenium-186, which is suitable for CNS therapeutic applications due to its properties [13] About Leptomeningeal Metastases (LM) - LM is a rare but serious complication of cancer, occurring in approximately 5% of cancer patients, often leading to terminal outcomes [12] - There are currently no FDA-approved therapies specifically for LM patients, highlighting a significant unmet medical need [12]

Core Insights - Plus Therapeutics, Inc. presented promising data on Rhenium (186Re) Obisbemeda for treating leptomeningeal disease, particularly in breast cancer patients, at the 2024 San Antonio Breast Cancer Symposium [1][2] Group 1: Clinical Trial Results - In the ReSPECT-LM Phase 1 clinical trial, 9 out of 20 patients with leptomeningeal metastases (LM) from primary breast cancer were treated, with the maximum tolerated dose not yet reached [3] - The patients received a single intrathecal dose of Rhenium (186Re) Obisbemeda, ranging from 6.6 to 66.14 mCi of radiation, with only one dose-limiting toxicity (thrombocytopenia) reported [3] - Best response rates included circulating tumor cell (CTC) response at 88% (7/8), MRI imaging response at 25% (2/8), and clinical response at 29% (2/7) [3] - Clinical benefit rates showed CTC at 100% (8/8), MRI imaging at 75% (6/8), and clinical at 71% (5/7) [3] - The median overall survival for the 9 breast cancer patients was 9 months, with 2 patients surviving beyond 600 days post-treatment [3] Group 2: Future Plans - The company plans to initiate a ReSPECT-LM Phase 1b single-dose breast expansion cohort in Q1 2025 to further evaluate the safety and efficacy of Rhenium (186Re) Obisbemeda [4] - Plus Therapeutics aims to rapidly advance into a breast cancer-focused expansion cohort alongside planned multiple-dose expansion trials [4] Group 3: Background on Leptomeningeal Metastases - Leptomeningeal metastases (LM) is a rare but serious complication of cancer, with breast cancer being the most common primary cancer associated with LM, affecting 3-5% of breast cancer patients [5][6] - The incidence of LM is increasing, partly due to longer survival rates of cancer patients and the ineffectiveness of standard chemotherapies in reaching sufficient concentrations in the cerebrospinal fluid [6] Group 4: About Rhenium (186Re) Obisbemeda - Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy designed for targeted high-dose radiation delivery in CNS tumors, optimizing patient outcomes [7] - The radioisotope Rhenium-186 is noted for its short half-life and effectiveness in destroying cancerous tissue while allowing for real-time imaging [7] - The drug is currently being evaluated in clinical trials for recurrent glioblastoma and leptomeningeal metastases, with funding support from the National Cancer Institute and the Cancer Prevention & Research Institute of Texas [7] Group 5: Company Overview - Plus Therapeutics, Inc. is focused on developing targeted radiotherapeutics for challenging CNS cancers, aiming to enhance clinical outcomes through innovative treatment approaches [8] - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [8]

Core Insights - Plus Therapeutics, Inc. has renewed its Master Services Agreement with Telix IsoTherapeutics Group, ensuring a reliable supply of cGMP Re-186, a key radioisotope for its lead candidate Rhenium (186Re) Obisbemeda [1][2] Group 1: Agreement Details - The renewed agreement enhances Plus Therapeutics' supply chain strategy by securing Re-186 through IsoTherapeutics and utilizing SpectronRx for final drug manufacturing, establishing a scalable supply chain for late-stage clinical trials and future commercial needs [2][7] - The focus of the agreement includes the production of aluminum perrhenate and the final processing of cGMP Re-186, enabling just-in-time manufacturing to support the overall supply chain [2][7] Group 2: Product Overview - Rhenium (186Re) Obisbemeda is an injectable radiotherapy designed for targeted high-dose radiation delivery in CNS tumors, aiming to optimize patient outcomes by reducing off-target risks compared to existing therapies [3] - The product is currently being evaluated in clinical trials for recurrent glioblastoma and leptomeningeal metastases, with support from the National Cancer Institute and a $17.6 million grant from the Cancer Prevention & Research Institute of Texas [3] Group 3: Company Background - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes recurrent glioblastoma and leptomeningeal metastases [4] - The company has established a strategic supply chain through partnerships to facilitate the development, manufacturing, and potential commercialization of its products [4]

Core Insights - CNSide Diagnostics, a subsidiary of Plus Therapeutics, presented data on the CNSide CSF Assay Platform, which identifies mutations in cerebrospinal fluid (CSF) for treatment selection in patients with leptomeningeal metastases (LM) [1][2] - The study analyzed 258 CSF samples from 66 LM patients, revealing extensive actionable mutational changes and clinically relevant biomarkers [1][2] Group 1: CNSide CSF Assay Findings - The CNSide CSF Assay evaluated 14 biomarkers, with 12 showing at least one change during treatment [2] - FISH analysis detected biomarker changes in 88% (58/66) of patients, identifying new actionable biomarkers in 26 cases [2] - ICC analysis revealed changes in 20% (13/66) of patients, with new actionable biomarkers identified in 7 cases [2] Group 2: Clinical Implications - The dynamic nature of biomarker mutation profiles in LM provides valuable insights for treatment strategies, highlighting the potential role of radiotherapeutics like Rhenium (186Re) Obisbemeda [2] - The data will be presented at the 2024 Society for NeuroOncology Annual Meeting, emphasizing the implications for differential treatment of LM [2] Group 3: Company Overview - CNSide Diagnostics develops proprietary clinical diagnostic assays to identify tumor cells that have metastasized to the central nervous system, with plans to commercialize the CNSide platform in the U.S. by 2025 [3][4] - Plus Therapeutics focuses on developing targeted radiotherapeutics for difficult-to-treat CNS cancers, with a pipeline that includes recurrent glioblastoma and LM [8]

Financial Data and Key Metrics Changes - The cash and investments balance was $4.8 million at September 2024, down from $8.6 million at December 2023 [20] - Year-to-date operating loss for 2024 was $10.8 million compared to $9.5 million in the same period of 2023, primarily due to increased spending related to the ReSPECT-LM trial [21] - Net loss year-to-date 2024 was $9.1 million or $1.46 per share, compared to a net loss of $9.5 million or $3.54 per share for the same period in the prior year [21] Business Line Data and Key Metrics Changes - The ReSPECT-LM program is advancing with a Phase 1 single-administration trial showing favorable safety and efficacy results, with a median overall survival of 12 months compared to a historical average of four months [7][8] - The CNSide Cerebrospinal Fluid Assay platform is being recognized for its diagnostic value, with plans for a limited market release in January 2025 [12][14] Market Data and Key Metrics Changes - The company is expanding its market access activities for the CNSide platform, including obtaining necessary certifications and negotiating with commercial payers [13][14] - The ReSPECT-GBM trial continues to enroll patients, with 42 patients enrolled across three sites, and the average absorbed radiation dose to tumors in Phase 2 was 300 gray, correlating with increased overall survival [15][16] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, including the ReSPECT-LM and ReSPECT-GBM trials, while also expanding its diagnostic capabilities with the CNSide platform [10][12] - A research collaboration with Brainlab aims to enhance treatment planning and drug delivery for brain cancer patients [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about grant funding opportunities, particularly from CPRIT, and indicated that the company is well-positioned for continued success in Texas despite potential federal changes [39][40] - The company anticipates significant milestones in 2024, including presentations at major conferences and the initiation of new clinical trials [25][30] Other Important Information - The company has received a $3 million grant from the US Department of Defense to support a Phase 1 trial for pediatric brain cancer [18] - A second GMP manufacturing partnership has been established to support future commercial demand projections for RNL [19] Q&A Session Summary Question: Opportunities for CNSide and RNL in LM - Management sees increasing synergies between CNSide and RNL, with potential to double or quadruple the addressable market for LM by improving diagnostic sensitivity [34] Question: Landscape for Grants - Management believes there are continued opportunities for grants, particularly from CPRIT, and expects to maintain a strong position in Texas [38][40] Question: LM Multi-Dose Study Dose Selection - The selected dose of 13.2 millicuries for the multi-dose study was based on safety and response data from previous cohorts, with a Bayesian approach to clinical development being utilized [44] Question: Timeline for CNSide Assay Compliance and Reimbursement - The company aims to commercialize the CNSide test in Q4 2024, with CLIA compliance and reimbursement negotiations ongoing [46]

Financial Performance - The company's cash and investments balance was $4.8 million at September 30, 2024, down from $8.6 million at December 31, 2023[5] - Total operating loss year to date through September 30, 2024, was $10.8 million, an increase from $9.5 million for the same period in 2023[5] - Net loss year to date through September 30, 2024, was $9.1 million, or $(1.46) per basic share, compared to a net loss of $9.5 million, or $(3.54) per basic share, for the same period the prior year[5] - Net loss for the three months ended September 30, 2024, was $2,874,000, compared to a net loss of $3,219,000 for the same period in 2023, showing an improvement of 10.7%[14] - The company reported a net cash used in operating activities of $9,343,000 for the nine months ended September 30, 2024, compared to $10,970,000 in 2023, indicating a reduction of 14.8%[15] - Cash and cash equivalents at the end of the period were $1,223,000, down from $11,006,000 at the end of September 2023[15] - Net cash provided by financing activities was $6,187,000 for the nine months ended September 30, 2024, compared to $3,974,000 in 2023, indicating an increase of 55.5%[15] Revenue and Grants - The company recognized $4.4 million in grant revenue year to date through September 30, 2024, compared to $3.6 million for the same period in 2023[5] - Grant revenue for the three months ended September 30, 2024, increased to $1,456,000 from $1,240,000 for the same period in 2023, representing a growth of 17.5%[14] - The company received a $0.9 million grant payment as part of a $3 million award from the Department of Defense to support clinical development for pediatric brain cancer[3] Operating Expenses - Total operating expenses for the nine months ended September 30, 2024, were $15,207,000, up from $13,063,000 in 2023, reflecting an increase of 16.4%[14] - Research and development expenses for the three months ended September 30, 2024, were $2,858,000, an increase from $2,493,000 in the same period of 2023, marking a rise of 14.6%[14] - General and administrative expenses for the nine months ended September 30, 2024, totaled $6,813,000, compared to $6,167,000 in 2023, reflecting an increase of 10.5%[14] Clinical Trials and Developments - The company completed enrollment in the Phase 1 ReSPECT-GBM trial and obtained FDA agreement to begin enrollment in the ReSPECT-LM trial expected to start in early 2025[3] - The ReSPECT-GBM Phase 1/2 trial showed promising feasibility, safety, response, and efficacy signals across 42 treated patients[3] - A GMP manufacturing partnership was established with SpectronRx to meet late-stage clinical and commercial forecasts for Rhenium (186Re) Obisbemeda[3] - The company plans to complete the ReSPECT-LM Phase 1 single dose trial and determine the maximum tolerated and recommended Phase 2 doses by year-end 2024[4] - The company anticipates launching the CNSide Cerebrospinal Fluid Tumor Cell Enumeration Assay Platform as a laboratory-developed test in 2025[4] Shareholder Information - The weighted average number of shares of common stock outstanding for basic calculations increased to 7,855,763 for the three months ended September 30, 2024, from 3,225,351 in the same period of 2023[14] - The company experienced a change in the fair value of warrants, resulting in an income of $960,000 for the three months ended September 30, 2024, compared to no income in the same period of 2023[14]