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NEWS -- Plus Therapeutics Receives $3 Million Award Recommendation from the United States Department of Defense
Plus now has $23 million in active awards support for the Company’s targeted radiotherapeutic pipeline
Funding for pediatric brain cancer treatment is expected to begin in Q3 2024, pending contract finalization
AUSTIN, Texas, April 22, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced 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 Q3 2024 and will support the planned expansion of the Company’s clinical trial for pediatric brain cancer.
“This recent award further extends our current cash runway in the second half of 2025, while supporting the 2024 expansion of our clinical development activities,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics. “In 2023, the Company applied for approximately $7 million in grant funding, and we plan to file for more than $10 million in funding in 2024.”
About the DoD Grant Program
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 FY23 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.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Charles Huang
Director, Capital Markets and Investor Relations
(202) 209 5751
mailto://chuang@plustherapeutics.com
NEWS -- Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. Join Plus’ Management Team
AUSTIN, Texas, April 09, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) has formally joined the Company in a part-time capacity. Dr. Brenner will provide substantial input on the Company’s central nervous system cancer development programs while continuing to maintain his academic practice and laboratory. In addition, Barbara Blouw, Ph.D. joins the Company as Vice President, Clinical Affairs.
“I am excited to be working more closely with the Plus team to accelerate the development of its radiopharmaceutical pipeline,” said Andrew Brenner, M.D., Ph.D. “Rhenium (186Re) obisbemeda has the potential to transform the treatment of CNS cancers, and I am pleased to be able to increase my commitment to Plus with the goal of accelerating the late-stage clinical development of the company’s existing trials in recurrent glioblastoma (GBM), leptomeningeal disease and pediatric brain cancer.”
Dr. Brenner is a board-certified internist, medical oncologist, and tumor biologist with a focus in drug development for the management of primary brain tumors and breast neoplasms. Dr. Brenner’s academic work focuses on both clinical cancer management and the development of novel therapies to treat breast and central nervous system tumors. Dr. Brenner has received numerous grants and investigational new drug approvals based on his translational research. Additionally, he has led multiple multicenter trials for the treatment of CNS neoplasms and served on Steering Committees for Phase III trials in GBM. He is a graduate of Texas A&M University and earned his doctorate in biological science and tumor biology at the University of Texas M.D. Anderson Cancer Center – Science Park. Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency at Texas A&M Health Science Center in Temple, Tx. He completed his fellowship in medical oncology at UT Health San Antonio.
Dr. Barbara Blouw has a Ph.D. from Utrecht University in the Netherlands and completed her postdoctoral research at the Sanford Burnham Prebys, Medical Discovery Institute, and the University of California, San Diego Division of Biological Sciences in basic cancer biopsy. Professionally, she has worked for Navigate Biopharma (a Novartis Company), Halozyme and Biocept. Dr. Blouw has a broad background in oncology research, clinical trial design, regulatory submissions, biostatistics, and clinical operations. She also has expertise in CNS biomarker development using in vitro and in vivo preclinical models and assay development and validations for clinical trial testing per the College of American Pathologists Laboratory Accreditation Program and Clinical Laboratory Improvement Amendments.
“As we prepare for the future, Plus is substantially strengthening its management in key areas such as cancer biology, neuro-oncologic clinical development, and central nervous system biomarker development,” said Marc H. Hedrick, M.D., M.B.A. “I have worked closely with both Dr. Brenner and Dr. Blouw for some time now, and they are important new additions for our future. Their positive impact will be felt immediately.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
PSTV under $2
NEWS -- Plus Therapeutics to Present at the National Comprehensive Cancer Network Annual Conference
AUSTIN, Texas, March 27, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that it will present a poster at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference, which will be held April 5-7, 2024, in Orlando, Florida.
NCCN 2024 Annual Conference – Orlando World Center Marriott
Poster: Friday, April 5, 2024 at 7:30am-8:30 am and 11:55am – 1:10 pm ET in the Exhibition Hall
Title: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases Phase 1 Dose Escalation Trial: Update of Initial Safety and Feasibility
Presenter: Norman LaFrance, MD, ME, FACP, FACNP, FACNM (Chief Medical Officer of Plus Therapeutics)
A copy of the poster presentation will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic
Plus’ CSF-01 cancer cell enumeration test is a sensitive and specific diagnostic test for the presence of adenocarcinoma and melanoma cancer cells in the leptomeninges
CSF-01 testing is used as an exploratory endpoint in the ReSPECT-LM trials
Controlled clinical trial data evaluating the utility of CSF-01 in clinical decision-making is anticipated to be released in Q2/Q3 2024
AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced 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 tumor cell enumeration assay is a highly specific and sensitive diagnostic test that is promising for both establishing the diagnosis of leptomeningeal metastases (LM) and following the disease course over time,” said Dr. Priya Kumthekar, Associate Professor, Feinberg School of Medicine, Northwestern University. “Current diagnostic methods lack the sensitivity and specificity to reliably inform clinical decision making, and the field is excited about the use of CSF-01 in the ReSPECT-LM trials as an exploratory endpoint and hopefully soon, for use in all patients in which LM is in the differential diagnosis.”
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.
“In mid-2023, the Company licensed CSF-01, as well as a broader CSF diagnostic testing portfolio due to high conviction that routine implementation will substantially improve diagnosis and clinical management of LM,” said Marc H. Hedrick, M.D., President & CEO of Plus Therapeutics. “Our initial objective was to make the test available for our ReSPECT-LM trial patients, which is now complete. Now, we are evaluating the FORSEE clinical trial data, which we anticipate reporting in the second or third quarter of 2024.”
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, we 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases
A total of 18 patients have been dosed in the trial to date
Company anticipates moving into Cohort 6 in Q2 2024 following standard safety review
AUSTIN, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced 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. There have been no dose limiting toxicities observed to date with administered radiation doses up to 66.14 millicuries in Cohort 5, a ten-fold increase over Cohort 1. 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 $17.6M grant from the Cancer Prevention & Research Institute of Texas (CPRIT). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM, ReSPECT-LM and ReSPECT-PBC and increase of ten o, clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript March 5, 2024
Plus Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.7, expectations were $-0.78. PSTV isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full Year 2023 Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties and including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time.
Plus Therapeutics advises you to review these risk factors in considering such statements. Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made. It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.
Marc Hedrick: Thank you, Victor. Good afternoon, everyone, and thank you once again for taking the time to join us today as we provide an overview of recent business highlights and discuss our 2023 full year financial results. And right upfront, apologies for the hoarseness in my voice as I come back from the flu. Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer; and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call this afternoon by reviewing our recent clinical and regulatory progress with a focus on the fourth quarter, and then turn the call over to Andrew to review our financials and Dr. LaFrance then will be joining us for Q&A. Let me begin with the updates on our two lead CNS cancer programs.
I think we're in an enviable position in the development of rhenium obisbemeda drug, in that with the recent progress we have made in LM. This effectively means we have two promising lead clinical programs for LM and recurrent GBM. Our ReSPECT-LM Phase 1/2 dose escalation trial of a single administration of rhenium obisbemeda for LM continues to show positive safety and efficacy signals and is making very good progress. In November 2023 at the Society for Neurooncology Meeting, or SNO, we presented results from the [technical difficulty], we showed that 13 patients with LM received a single intraventricular dose of rhenium obisbemeda between 6.6 escalating up to 44 millicuries through an indwelling Ommaya reservoir. No DLTs were observed and the maximum feasible dose was not reached.
The majority of adverse events were mild, 64% Grade 1 or moderate 27% Grade 2. And overall critical organ radiation doses were low. Rhenium obisbemeda circulated throughout the CSF space by one hour following administration and persisted in the CSF for up to seven days, again, with a single administration. CSF [technical difficulty] decreased by up to 91% following rhenium obisbemeda treatment, and the mean reduction was 53%. Seven of 13 treated patients remained alive at the time of reporting, with a median overall survival of 10 months for patients in the first three cohorts. That's cohorts one, two, three. Enrollment is on track to finish the Phase 1 single administration dose escalation trial by year-end 2024 and also along the way to determine a recommended Phase 2 dose for a single administration Phase 2/3 trial.
This assumes complete enrollment through cohort 7 and currently, we anticipate that cohort 7 is likely the max dose. Cohort 4 just completed was the fastest enrollment of all the cohorts to date and cohort 5 is now enrolling. I can tell you that for both the neuro-oncology community at sites, enthusiasm remains very high for this trial, and we have recently onboarded five new clinical trial sites. Later this year, our plan is to meet with the FDA and discuss the potential Phase 2/3 pivotal trial design, assuming the dataset remains positive and continue tolerated development approach focusing on metastatic breast cancer for which we have orphan designation. This would be for a single administration of rhenium obisbemeda. The trial size endpoints and other key trial elements will be discussed later on in the year, but we anticipate substantial financial support for this trial through our award.
In terms of LM data, we anticipate presenting interim safety and feasibility data from the ReSPECT-LM trial at the SNO/ASCO CNS Cancer Conference in August of 2024 and likely updating that for the full Phase 1 at the SNO Annual Meeting in November 2024. We are also currently working to expand the LM trial to accommodate multiple doses to maximize disease impact in the long term. As an aside, patients are requesting additional treatments of rhenium obisbemeda following their first administration in our current trial, so we are increasingly treating more patients with additional doses under compassionate use protocol, which anecdotally seems to be going well from both a safety perspective and the clinical impact, both of which are being closely followed.
We have developed a proposed approach for a multiple dose expansion and anticipate meeting with the FDA in 2024 with the goal of enrollment beginning for dosing expansion in early 2025, if not before. Now let's switch gears a bit, but still within the LM discussion. Please recall that we acquired rights to a highly specific sensitive cerebrospinal fluid tumor cell testing technology in September of 2023. We remain exceptionally encouraged by this test. But as you may recall, the prior company had very significant financial and operating issues. Our rationale for acquiring this was that because it could, A, double the market size for our LM therapeutic because of its significant diagnostic sensitivity improvement over standard-of-care but also it allows for longitudinal disease assessment that is otherwise very difficult or impossible to do with the current standard-of-care in testing.
The update on this test is that we have successfully implemented the test back into our ReSPECT-LM trial, losing only a few patients in cohort 4 as of February 2024. The diagnostic work is being conducted in conjunction with our partner, K2bio in Houston. The assay uses proprietary technology and a broad panel of 18 monoclonal antibodies largely geared towards various adenocarcinomas and melanoma. Working with K2, we can perform the test in a cost-effective manner for our trials and leverage existing grant funding for support. We are in the process of assessing whether broadening the test commercially beyond our trials and our current partnership with K2 is indeed viable. But overall, we continue to think this potential exciting new upside opportunity is great for the company.
Now finally, the ReSPECT-LM Phase 1 program continues to be funded in part through CPRIT, the state of Texas through a three-year $17.6 million product development research award. That continues to go very well. And in September, we received a planned $1.9 million payment followed by a $3.3 million payment this past December as part of the grant contract. To date, we have received approximately $7 million from CPRIT, and we anticipate receiving an additional $6.9 million throughout 2024. And I think Andrew will provide more detail on the CPRIT grant revenue in a moment. Now an update on our ReSPECT-GBM trial of a single dose of rhenium obisbemeda given via convection-enhanced delivery to patients with recurrent glioblastoma or GBM. ReSPECT-GBM continues to enroll patients, and we are actively adding new clinical trial sites.
Until recently, we have been limited in terms of trial sites based on the NCI NIH grant funding award, which has substantially supported this trial through the principal investigator, Dr. Andrew Brenner and the University of Texas. Going forward, in 2024, we will expand trial sites, more efficiently interface with sites and provide broader and more direct corporate support for the trial. We are incredibly grateful for the five-year support from the NCI University of Texas and the trial PI, up to this point, as we take the ball and move the trial from Phase 2 to a pivotal trial. We anticipate adding a total of five to eight new sites this year, which is currently ongoing, and we think that's going to provide a strong starting basis for a pivotal trial commencing in 2025.
The impact of those sites of enrollment will be felt in the latter part of 2024, and we hope to complete Phase 2 enrollment in late 2024 or early 2025. Last November, we presented initial positive safety and feasibility data from the Phase 2 ReSPECT-GBM trial at the SNO meeting last November. As a reminder, the primary endpoint of that Phase 2 is to assess overall survival following a single dose of rhenium obisbemeda in recurrent GBM and compare that to standard-of-care. In summary, that data showed median overall survival in the 15 patients from the Phase 2 study treated at that time was 13 months median overall survival, 13 months versus approximately eight months for the standard of care, and nine of the 15 patients remained alive at the time of the analysis.
Median progression-free survival was 11 months compared to bevacizumab, which is 3.4 months. Rhenium obisbemeda continues to demonstrate a very favorable safety profile despite delivering up to 20x the dose of radiation that is typically delivered by external beam radiation therapy for GBM, and that's typically around 35 gray and we've gone up to 740 gray and the mean dose we're giving now is about 300 to 350 gray. In 13 of 15 patients or 86% of patients have thus far met the empirically derived rhenium obisbemeda dosing target threshold that we've established in Phase 1 and in preclinical studies of greater than 100 gray average absorbed dose to the tumor in greater than 70% tumor coverage. The Phase 2 trial performance in terms of median overall survival will be controlled in the Phase 2 using real-world data generated in conjunction with our partner metadata who has a sizable database in GBM in a history of using that successfully in GBM trials with the FDA.
In the Phase 1, with metadata, we conducted two real-world data trials in our GBM and one versus bevacizumab monotherapy and another versus other convection-enhanced delivery trials that were propensity matched to our Phase 1 data. In those two trials in terms of median overall survival, that was aligned with the recent meta-analysis showing current standard-of-care in recurrent GBM in terms of median overall survival is approximately eight months. And so currently, we view that as an effective clinical hurdle rate, if you will, in a Phase 2 and in a pivotal. So comparing our Phase 2 data as it stands to - as of November of last year versus real-world data, that's the last time we reported data, a median overall survival, as a reminder, was 13 months, which is 63% better than current standard-of-care which is bevacizumab monotherapy, for example, that has - carries an overall survival of approximately eight months.
Also, I'd like to highlight another presentation of our imaging data that was also presented at the same meeting in November by the trial PI. Imaging is an important secondary endpoint in the trial, supporting the overall survival signal. It has until recently been difficult to assess because pseudo progression has been commonly noted in patients that are receiving such a high dose of radiation, namely 10x to 20x over EBRT. It was a very technical presentation and can be found on our website, but the bottom line is that using advanced imaging techniques beyond standard MRI and T1 T2-weighted images, using things such as relative cerebral blood volume, treatment response assessment maps and fit books, we can increasingly, if not reliably delineate pseudoprogression from progression as well as better understand patterns of recurrence, and we think this is going to help ensure that we are able to more rapidly develop and improve upon this novel new therapy for GBM, but also adapted for primary GBM and other brain cancers in children and adults.
And related to that point above, I thought it might be useful for me to take a couple of minutes and do a little bit of a forward-looking reframe of this GBM development program that we've been working on and look at it in sort of a unique way based on what we've learned over the last over three years of development. In my view, what we've developed is not - it's not ideal to think about this as sort of a pure-play GBM drug therapeutic per se. But rather, I think it's more accurate to think about this as a novel targeted radiotherapeutic delivery ecosystem that can overcome not just the limitations of external beam radiation therapy, which is the mainstay of GBM therapy. In other words, we've increased by 10x to 20x the amount of absorbed radiation dose over EBRT.
But when you couple that with the state-of-the-art imaging, the custom treatment planning with specific software that's now available, the neuronavigational technology and convection-enhanced delivery catheters that are optimized, we can also overcome the limitations of blood brain barrier that makes drugging GBM a very challenging matter and also overcome the limitations of the aggressive local invasiveness that is well known with GBM, which makes complete surgical resection almost impossible. So given the safety margins that we have seen thus far, with only a single administration of the radiotherapeutic drug and using the convection-delivery modality, we see tremendous opportunity and potential in both improving upon the standard-of-care in radiation delivery for GBM, which is EBRT in general but also improve upon current standard approaches for recurrent GBM such as surgery and chemotherapeutics and then expanding into other CNS tumor types of the brain parenchyma.
And I'm happy to discuss this more in the Q&A session. Now in terms of data, we anticipate an update at SNO in November 2024. We also intend to meet with the FDA in 2024, both on the GBM pivotal trial design and to obtain FDA IND approval to begin enrollment of the ReSPECT pediatric brain cancer trial for children with high-grade glioma and ependymoma. To meet our clinical goal of being in pivotal trials in 2025 with rhenium obisbemeda drug, we are focused in 2024 to expand our GMP manufacturing relationships, such that we have two fully validated manufacturers that can support primary drug supply, backup drug supply, scale-up activities and all foreseeable commercial demand forecast. So relatedly, we are working to build in redundancy in all supply chain intermediaries, including radioisotope target and radiation services.
We think rhenium is an exciting new clinically relevant radioisotope and interest in that is very high. We are currently on track to meet both of these important drug production supply objectives. In terms of building out the pipeline, we are focusing on two discrete areas. Our new radiotherapeutic, which is rhenium nanoliposome biodegradable alginate microsphere long term, but we call it RNL BAM and building on our organizational expertise and success in obtaining nondilutive grant funding. First, as it relates to RNL BAM, as a reminder, this is a next-generation radioembolic device as it's now designated by the FDA as of last year, which is designed to treat a variety of solid organ tumors. As the FDA path is now resolved, we are analyzing key device design attributes that we think will ensure this is an attractive product for both liver cancer and other cancers, and we'll provide more updates as that develops over the year.
Second, as to the issue of grants. We currently have over $20 million in active awarded funding for our two lead programs in LM and GBM. In 2023, we filed for approximately $7 million in grant funding and plan to increase that to at least $10 million in 2024. As per our practice, we report on specific grant funding only when awarded. Now with that update, I'll turn the call over to our CFO, Andrew Sims, who will review the financials. Andrew?
Andrew Sims: Thank you, Marc, and good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and year ended December 31, 2023. As of December 31, 2023, cash and cash equivalents were $8.6 million compared to $18.1 million as of December 31, 2022. We are projected to receive an additional $6.9 million in grant funding from CPRIT in 2024, with $3.3 million in the first half of 2024, and a balance of $3.6 million by the end of the year. In addition, as Marc mentioned, the company continues to benefit from grant awards of $3 million from the NIH to support the GBM trial through Phase 2. Based on the cash on hand and committed grant funding, our current balance sheet provides runway into the second half of 2025.
The company recognized $4.9 million of grant revenue during the year ended December 31, 2023, compared to $0.2 million in 2022, reflecting the progress made on the LM indication in 2023. We expect grant revenue will continue to increase during 2024 and the remaining term of the CPRIT grant through August 2025 as we plan to expand the LM clinical trial to add clinical sites and enroll additional patients. Total operating expenses for the year ended December 31, 2023 of $18.2 million compared to $19.7 million in the same period 2022. The decrease due to lower professional and legal expenses. Other income increased from $147,000 in 2022 to $400,000 in 2023 and fully offset interest expense. As a result of these changes, the net loss decreased by $6.9 million from $20.3 million in the year ended December 31, 2022, to $13.3 million in the year ended December 31, 2023.
And now I'll turn it back to you, Marc.
Marc Hedrick: Great. Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on selected key milestones anticipated over the next 12 months. First, we had safety and efficacy data from the Phase 1 ReSPECT-LM trial with the SNO/ASCO CNS meeting in August of 2024 and likely further update at the full-on SNO meeting in October 2024. We anticipate completing the Phase 1 trial in LM by the end of 2024, and we're on track [technical difficulty] conjunction develop a Phase 2/3 pivotal trial design for breast cancer patients with LM in conjunction with the FDA. We will also be working with the FDA in 2024 to develop a multiple dosing approach to potentially further extend tumor impact of the rhenium obisbemeda and leptomeningeal patients.
In our GBM program, we intend to expand trial sites, as mentioned, and complete enrollment in the Phase 2 trial by late 2024 or early 2025 and in parallel finalized pivotal trial design planning with the FDA that's partially done at this point. Pending IND clearance from the FDA, we intend to initiate the Phase 1 pediatric brain cancer trial for pediatric brain cancer patients. And we also plan to bolster our rhenium obisbemeda supply chain for commercial readiness in 2024 as well as complete device development optimization milestones for our next-generation radioembolic device, RNL BAM. Now with those key milestones, I'll turn the call back over to Victor to introduce any questions we might have. Victor?
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PSTV 10Q due March 5
NEWS -- Plus Therapeutics to Announce Fourth Quarter and Full Year 2023 Financial Results and Host Conference Call on March 5, 2024
AUSTIN, Texas, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report fourth quarter and full year 2023 financial results on Tuesday, March 5, 2024, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Conference Call & Webcast
Tuesday, March 5, 2024 @ 5:00 PM ET
Dial-in Link: https://register.vevent.com/register/BIa3e26b40a05b4e7185cb3d97450dd3c4
Webcast: https://edge.media-server.com/mmc/p/p7t4p29q
Participants may also pre-register any time before the call through the dial-in link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Updates Financial and Cash Guidance for 2024
Plus Receives $3.3M in grant revenue in Q4 2023
Forecasts additional $6.9M of grant revenue for 2024
Enters into debt restructuring deal with Pershing Capital to reduce 2024 cash burn by $3.7M
AUSTIN, Texas, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced financial updates and guidance for 2024.
Plus is currently in the second year of a Cancer Prevention and Research Institute of Texas (CPRIT) award totaling $17.8 million. The grant funds are advances on future spend and received based on hitting certain milestones. The $3.3 million payment is the first advance for the second year of the award. The Company forecasts an additional $6.9 million in grant revenue during the 2024 calendar year.
Furthermore, the Company currently has a debt facility with Oxford Finance LLC. The remaining balance of the facility is $0.7 million as of YE 2023 with a $3.3 million deferred interest payment due in June 2024. The new facility carries a lower interest rate and principal payment flexibility allowing for principal payments to be deferred into 2025 and beyond and is expected to close in January 2024.
“This combination of forecasted non-dilutive grant revenue and debt restructuring significantly strengthens our balance sheet and reduces our burn,” said Andrew Sims, Chief Financial Officer of Plus Therapeutics. “Following closure of the debt restructure, the Company should have capital sufficient to extend the runway to the second half of 2025.”
To date, the Company has received $7 million from CPRIT and, in 2024, anticipates receiving an additional $6.9 million, $3.3 million in Q2 and $3.6 million in Q4, as part of the planned cadence of award payments. The Company reported $11.0 million in cash as of September 30, 2023. The Company believes that the award payment together with its cash on hand provide sufficient runway to fund operations to the second half of 2025.
Plus’ grant from CPRIT provides for funding over the three-year grant period which began on August 31, 2022, and covers the majority of the development costs of the Company’s lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of patients with leptomeningeal metastases (LM).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 281 distinguished researchers, supported the establishment, expansion or relocation of 52 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 8.2 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at cprit.state.tx.us.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,”, “forecast”, “believes”, “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; the anticipated completion of the ReSPECT-GBM Phase 2 enrollment; the continuation of the ReSPECT-GBM phase 1 trial to maximum tolerated dose and the next phase of the program; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Partners With K2bio for Development of Novel Tests for Cerebrospinal Fluid (CSF) Tumor Cell and Molecular Biomarker Analyses
Collaboration to explore novel CSF cancer testing modalities and initial testing panel to be available in Q1 2024 for ReSPECT-LM patients
AUSTIN, Texas, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that it has partnered with K2bio (Houston, Texas) to implement novel analysis for cerebrospinal fluid (CSF) tumor and molecular biomarkers for CNS cancers. Initial clinical specimen processing and testing will begin in Q1 2024 in the Company’s ongoing Phase 1 ReSPECT-LM trial of rhenium (186Re) obisbemeda in patients with leptomeningeal metastases (LM). This trial is currently receiving grant funding through The Cancer Prevention and Research Institute of Texas (CPRIT). The Company expects testing costs to be partially covered under this grant.
“The initial diagnosis, therapeutic selection and monitoring of patients with CNS cancers such as leptomeningeal metastases are significant problems in everyday clinical practice,” said Marc H. Hedrick, M.D., President & Chief Executive Officer of Plus Therapeutics. “To turn these very lethal CNS cancers into treatable diseases, we must ideally address both the diagnostic as well as the therapeutic needs of caregivers and patients. This partnership with K2bio is the next part of our overall strategy to address both needs in parallel.”
K2bio is a hybrid contract research organization (CRO) enabling life science companies to develop the next generation of innovative therapies. K2bio is based in Houston and is part of the Texas Medical Center life sciences ecosystem specializing in all aspects of translational cancer diagnostic and therapeutic research and development.
“K2bio is a leader in enabling rapid diagnostic and therapeutic progress for innovative companies such as Plus,” said Colby Suire, PhD, acting President and CEO of K2bio. “We have all the necessary capabilities and expertise to accelerate and support Plus’ mission to be a leader in the development of targeted radiotherapeutics and related diagnostics for CNS cancers.”
Plus’ tumor cell and molecular biomarker analysis is an exploratory endpoint in the ReSPECT-LM Phase 1 trial that has shown promise in early cohorts. In Phase 1/part A of the ReSPECT-LM trial presented at the 2023 SNO/ASCO Meeting in San Francisco, Plus data showed an average 53% reduction in CSF tumor cells 28 days after a single intrathecal administration of rhenium (186Re) obisbemeda in patients with LM.
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). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; the anticipated completion of the ReSPECT-GBM Phase 2 enrollment; the continuation of the ReSPECT-GBM phase 1 trial to maximum tolerated dose and the next phase of the program; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics to Present at the 5th Targeted Radiopharmaceuticals Summit Europe
AUSTIN, Texas, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that Marc H. Hedrick, M.D., President and Chief Executive Officer, will deliver a presentation at the 5th Targeted Radiopharmaceuticals Summit Europe, being held December 5-7, 2023 in Berlin, Germany.
5th Annual Radiopharmaceuticals Summit Europe
Presentation Title: Re-186 Radiolabelled NanoLiposomes for Rare Brain and Spinal Cord Tumors
Date/Time: Wednesday, December 6, 2023 at 1:00 – 1:30pm CET
Session: Taking a Deep Dive into Novel Targets & Their Basics to Understand How They Affect TRP Development
Location: Berlin Marriott Hotel
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Reports New Interim ReSPECT-GBM Phase 2 Trial Data at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar
AUSTIN, Texas, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today 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. The Company is hosting a virtual key opinion leader (KOL) webinar to discuss the data today at 10:00 am ET. To register for the event, please click here.
“GBM needs better treatment options, and we are highly encouraged by the initial data from the NIH-supported ReSPECT-GBM Phase 2 trial of rhenium (186Re) obisbemeda in rGBM,” said Marc H. Hedrick, M.D., M.B.A., President and Chief Executive Officer of Plus Therapeutics. “We believe the data presented at SNO suggests that rhenium (186Re) obisbemeda confers a survival benefit over published standard of care data and our own real world data assessments of propensity matched controls. Our 2024 focus will be onboarding additional clinical sites, completing Phase 2 enrollment, continuing the Phase 1 trial to maximum tolerated dose, and planning next steps for the program.”
“The interim ReSPECT-GBM Phase 2 data coupled with the novel imaging analyses reported at SNO further strengthens the compelling therapeutic rationale for the use of rhenium (186Re) obisbemeda on malignant gliomas,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-GBM clinical trial. “The Phase 2 clinical outcomes thus far show effects consistent with the group of patients in the Phase 1 dose escalation trial that received both a therapeutic dose of radiation of greater than 100 Gy and tumor coverage of greater than 70%."
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).
NEWS -- Plus Therapeutics to Host Virtual KOL Event on New Phase 2 ReSPECT-GBM Data in Recurrent Glioblastoma Presented at the Society for NeuroOncology (SNO) Conference on Monday, November 20, 2023
AUSTIN, Texas, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it will host a virtual KOL event on Monday, November 20, 2023 at 10:00 AM ET to discuss new Phase 2 ReSPECT-GBM data in recurrent glioblastoma presented at the Society for NeuroOncology (SNO) Conference. To register, click here.
The event will feature presentations from neuro-oncology expert and principal investigator Andrew Brenner, M.D., Ph.D. (Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio) and neurosurgeons Toral Patel, M.D. (UT Southwestern Medical Center, Peter O’Donnell Jr. Brain Institute) and John Floyd, M.D. (UT Health San Antonio, UT Health Medical Arts & Research Center), who will discuss the unmet need and current treatment landscape for patients with rGBM, the potential of rhenium (186Re) obisbemeda in rGBM, and key highlights from the new Phase 2 data presented at SNO.
A live question and answer session will follow the formal presentations.
About Andrew Brenner, M.D., Ph.D.
Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center Center at UT Health San Antonio, is a specialist in both breast cancer and malignancies of the brain and spinal cord. He not only focuses on clinical management, but also on the development of novel therapies to treat breast cancers and central nervous system tumors.
A graduate of Texas A&M University, he earned his bachelor’s degree in biochemistry and went on to earn his doctorate in biological science and tumor biology at The University of Texas M.D. Anderson Cancer Center – Science Park. His doctoral thesis focused on the role of the cyclin dependent kinase inhibitor p16INK4a in mammary tumorigenesis and immortilization. Dr. Brenner’s current interests have transitioned from cell cycle to the effect of hypoxia on chemokines and escape from antiangiogenics and the role of obesity in promoting breast tumorigenesis.
Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency in internal medicine at Scott and White Hospital in Lubbock. He completed his fellowship in hematology and medical oncology at the UT Health San Antonio.
About Toral Patel, M.D.
Toral Patel, M.D., is an Assistant Professor in UT Southwestern Medical Center’s nationally ranked Department of Neurological Surgery, where she specializes in brain tumor surgery.
Dr. Patel received her undergraduate degree in biomedical engineering from Johns Hopkins University and earned her medical degree at UT Southwestern Medical School. She completed an internship in general surgery at Yale-New Haven Hospital, followed by a residency in neurological surgery, serving as Chief Resident. She then received advanced training in neurosurgical oncology through a fellowship at Memorial Sloan Kettering Cancer Center before returning to UT Southwestern as a faculty member in 2014.
Dr. Patel’s research has garnered numerous awards, including the William F. Collins Resident Research Award, a Seed Grant from the American Medical Association, the UT Southwestern Medical Student Summer Research Award, the Louis E. Goodman Award, and the Johns Hopkins University Department of Biomedical Engineering Undergraduate Research Award. She currently holds a patent titled “Highly penetrative nanocarriers for treatment of CNS disease” for her research into how nanoparticles can be used to carry drugs directly to the site of brain tumors.
Dr. Patel is a member of the Society for Neuro-Oncology, the American Medical Association, the American College of Surgeons, the Congress of Neurological Surgeons, and the American Association of Neurological Surgeons.
She was included in D Magazine‘s Best Doctors list for 2018.
About John Floyd, M.D.
John Floyd, M.D., Professor of Neurosurgery and Otolaryngology, serves as the Chair of the Department of Neurosurgery and the Carl Raba Family Chair in Neuro-Oncology at the Long School of Medicine at UT Health San Antonio. He began his medical career in high school after obtaining early acceptance to the University of Alabama School of Medicine at the age of 18. Prior to matriculating, Dr. Floyd finished his undergraduate degree, graduating summa cum laude. He studied public health policy and clinical trial design at the University of Adelaide, South Australia on a rotary international scholarship.
Dr. Floyd’s surgical training began at the prestigious Vanderbilt University Medical Center in Nashville, Tennessee, where he completed an internship in general surgery. Subsequently, he finished his neurosurgical training from the department of neurological surgery at Vanderbilt University Medical Center. Dr. Floyd has also completed a fellowship in neurosurgical oncology and skull base surgery at the University of Texas M.D. Anderson Cancer Center.
About Rhenium (186Re) obisbemeda
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-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 live 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s proposed share repurchase program; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical development plan and trials; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; restrictions under the Company’s debt facility; the inability to repurchase shares, or a decision not to repurchase shares; future changes in strategic direction; unexpected expenses; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Granted U.S. FDA Orphan Drug Designation to Rhenium (186Re) Obisbemeda for the Treatment of Breast Cancer with Leptomeningeal Metastases
AUSTIN, Texas, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to rhenium (186Re) obisbemeda for the treatment of breast cancer with leptomeningeal metastases (LM).
ODD status is granted by the FDA to an investigational drug or biological product intended to prevent, diagnose or treat a rare diseases or condition affecting fewer than 200,000 people in the United States. Companies granted ODD are eligible for certain benefits, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and 7 years of post-approval marketing exclusivity.
“Receiving Orphan Drug Designation from the FDA is important validation of our radiotherapeutic candidate for breast cancer patients with LM who currently have no FDA-approved treatment options,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “LM is a rapidly progressing and fatal complication of several cancers, including breast cancer, and incidence continues to rise. ODD status, together with the previously granted Fast Track designation, underscores the significant and urgent need for new treatment options for LM. We believe rhenium (186Re) obisbemeda has the potential to address this unmet need, and we look forward to continued progress of our ReSPECT-LM program.”
Rhenium (186Re) obisbemeda is currently being evaluated in the ReSPECT-LM Phase 1/2a dose escalation clinical trial. Cohort 4 of the ReSPECT-LM trial recently completed enrollment, and the Company anticipates moving into Cohort 5 following standard safety review. Updates on the ReSPECT-LM trial will be presented at the Society for Neuro-Oncology Annual Meeting November 15-19, 2023. In addition to ODD, the FDA previously granted rhenium (186Re) obisbemeda Fast Track designation for the treatment of LM.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
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-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 live 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the Company’s proposed share repurchase program; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical development plan and trials; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; restrictions under the Company’s debt facility; the inability to repurchase shares, or a decision not to repurchase shares; future changes in strategic direction; unexpected expenses; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript
Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript October 31, 2023
Operator: Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Third Quarter 2023 Results Conference Call. Before we begin, we want to advise you that over the course of the call and question-and-answer session, forward-looking statements will be made regarding events, trends, business prospects and financial performance, which may affect Plus Therapeutics' future operating results and financial position. All such statements are subject to risks and uncertainties, including the risks and uncertainties described under the Risk Factors section included in Plus Therapeutics' annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission from time to time. Plus Therapeutics advises you to review these risk factors and considering such statements Plus Therapeutics assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
It is now my pleasure to turn the floor over to Dr. Marc Hedrick, Plus Therapeutics' President and Chief Executive Officer. Sir, you may begin.
A medical scientist holding up a test tube, illustrating biopharmaceutical research.
Marc Hedrick: Thank you, Tawanda. Good afternoon, everyone. Thank you once again for taking time to join us today as we provide an overview of recent business highlights and discuss our 2023 third quarter financial results. Joining me for the call today are Mr. Andrew Sims, our Chief Financial Officer; and Dr. Norman LaFrance, our Chief Medical Officer. I'll begin the call by reviewing our recent clinical and regulatory progress with a focus on the third quarter and then turn the call over to Andrew to review our financials. Dr. LaFrance will then be joining us for Q&A. I'll begin with updates on our two lead radiotherapeutic CNS cancer programs, starting with recurrent glioblastoma rGBM. Our ReSPECT-GBM trial of Rhenium-186 Obisbemeda in patients with GBM funded substantially by the [Technical Difficulty] it is to enroll as we work to add new sites in order to complete enrollment of the Phase II by the end of 2024.
In parallel to the active Phase II trial, the Phase I dose escalation trial continues to enroll. Assessing the effects of very high administered radiation doses in large volumes to bigger size tumors on radiation distribution, tumor coverage and safety. We presented an update on the ReSPECT-GBM trial at the Society for Neuro-Oncology ASCO meeting in August. To summarize the safety data, a single administration of Rhenium-186 Obisbemeda is generally well tolerated with no dose-limiting toxicities and minimal systemic radiation exposure across 34 GBM patients. In addition, no patients experienced treatment-related adverse events with the outcome of death and no patients withdrew due to AEs. Most AEs were mild or moderate in intensity and nonserious.
The maximum tolerated dose was not reached. With regard to efficacy, as we briefly discussed last quarter, we found that overall survival is highly correlated with absorbed dose and treated tumor volume. In the data set presented at SNO/ASCO, the median absorbed radiation dose to the tumor was 308 gray. When we look at the median overall survival in the Phase I trial through Cohort 6, for patients with absorbed doses less than 100 grey, median overall survival was 22 weeks or about five months. And in contrast for patients with absorbed doses greater than 100 gray, median overall survival was 70 weeks or almost 18 months. Applying the Cox proportional hazard statistical model, we have found that for each 100 gray increase in total absorbed dose, the risk of death decreased by 45.6% and for each 10% increase in the ratio of treated to total tumor volume, the risk of death decreased by 66.9%.
This data can be found in much greater detail on our website. In addition, we continue to assess data from the ongoing Phase II trial. New safety and efficacy data from the Phase II will be presented at SNO in November. Following the SNO meeting, we will be hosting a key opinion leader webinar of investigators to discuss the data in detail. This webinar will feature Neuro-Oncology expert, Dr. Andrew Brenner, who is a principal investigator on the trial and is presenting the data at SNO as well as others. We'll be sharing the details of this event soon and invite you to join us as we delve into the data with these experts more deeply. Now let me update you on our ReSPECT-LM Phase I/IIa dose escalation trial of Rhenium Obisbemeda for patients with leptomeningeal metastases or LM.
This is a trial that is substantially funded by the State of Texas through CPRIT. Following a successful FDA Type C meeting in Q3, we rapidly completed Cohort 4 in the LM trial. Cohort 4 is the first of four planned cohorts in Part B of the Phase I trial. Completing the dosing in Cohort 4 was the fastest enrollment of all the cohorts to-date and enthusiasm from sites to participate enroll patients remains high. Prior to our FDA meeting, we completed Part A of the Phase I trial, specifically cohorts one through three. This past August, we presented the results of these cohorts at the SNO/ASCO meeting and provided further explanation and context at the KOL roundtable event following the August meeting. In summary, for the first three cohorts, the data shows a favorable safety profile and no dose-limiting toxicities have been reached.
Pharmacokinetic analysis showed that the drug circulated rapidly throughout the CSF space and remained there for at least seven days following single administration. Using the CNSide tumor cell enumeration assay, we found that an average reduction of tumor cell counts at 28 days post-treatment of 53%. And finally, median overall survival was 10 months with five of 10 patients still alive. We also presented LM data at the CPRIT innovations in cancer [Technical Difficulty] in September. As mentioned, the ReSPECT-LM Phase I program continues to be funded in part by CPRIT through a three-year $17.6 million product development research funding award. In September, we received a planned $1.9 million advanced payment as part of the grant contract.
Andrew will discuss the forecasted grant revenue going forward for the next couple of years in a moment. Now I'll provide some further color on the CNSide assay used in our LM trial and the license agreement we negotiated for the assay in August. Taking a look at the big picture first. The diagnosis of LM and the monitoring of treatment response are notoriously difficult in LM even with our state-of-the-art imaging clinical evaluation and traditional cerebrospinal fluid evaluation. In contrast, the CNSide assay is highly specific and sensitive as a measure of CSF tumor cell enumeration that quantitates a number of tumor cells per mL of CSF. This technology represents a substantial improvement in assessing CSF tumor cells compared to the standard of care.
At Plus, although we are initially pretty skeptical of the value of the technology and use it as a potential secondary endpoint, our team has seen the value of the assay first-hand in our LM trial and to paraphrase one of our LM trial investigators, the CNSide assay is a "game changer" for LM disease diagnosis and monitoring. And therefore, it's obviously quite synergistic with our therapeutic approach. The company that developed the test Biocept, those has been in financial distress throughout 2023 and declared their insolvency earlier this month. I want to make it clear that the company's financial distress was not in any way based on the quality of the utility of the assay, but upon a variety of unrelated factors. However, prior to Biocept's announcement and because of this very concern, Plus successfully completed the transfer of all proprietary materials [Technical Difficulty] and equipment from Biocept to use the CNSide assay.
And now as per our plan, we're the test to no longer be commercially available to us, as it is not now, Plus can now begin CSF tumor cell enumeration testing limited to the ReSPECT-LM trial patients. Separately, we will consider whether to exercise the exclusivity option that we have which is exercisable through the end of 2024 under the current license. In the meantime, we'll monitor the insolvency proceedings closely. Now back to our LM trial. We plan to initiate dosing in Cohort 5 this quarter pending DSMB approval. In terms of next step for ReSPECT-LM, we will continue to focus on enrollment, site on-boarding, data assessment and planning for next steps, including Phase II. In terms of our pediatric trial, we continue to make steady progress in initiating our first in child pediatric brain cancer trial.
Travel initiation is behind our original schedule as the FDA has required substantially more supporting data from us, particularly from our ongoing trials. We had a positive follow-up meeting in Q3, and all FDA requests are both reasonable and satisfactorily addressable within the next quarter. Thereafter, pending IND clearance from the FDA anticipated to be in early 2024, we plan to initiate the Phase I ReSPECT pediatric brain cancer trial for pediatric patients with the ependymoma and high-grade glioma at Lurie Children's Hospital in Chicago. Our other novel radiotherapeutic Rhenium-188 nanoliposome biodegradable alginate microsphere or BAM for short continues to make regulatory development progress. As a reminder, BAM is a radioembolization compound designed to treat a variety of solid organ tumors.
We recently received feedback from the FDA regarding its regulatory designation and the BAM radioembolic product will be regulated as a device, primarily by CDRH. We view this as very good news as the clinical requirements and timeline for approval will be reduced in existing reimbursement paths are already in place. Our 2024 corporate goals for BAM will include specific guidance for development based on FDA -- the FDA regulatory decision. Now in terms of drug production, behind the scenes, we continue to expand and shore up existing supply agreements and work to build in across-the-board supply chain redundancy, including as it relates to isotope availability. As we complete new agreements or relationships, we will communicate those. And with that, I'll turn the call over to our Chief Financial Officer, Andrew Sims, who will review the financials.
Andrew?
Andrew Sims: Thank you, Marc. Good afternoon, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the third quarter ended September 30, 2023. As of September 30, 2023, cash and cash equivalents were $11 million, which is in line with the balance at June 30, 2023. In addition, as of today, Plus has met the requirements to receive the next cash advance from CPRIT of $3.3 million, which we expect to receive prior to reporting our 2023 full year results. Plus also remains on track to receive additional advances in 2024, amounting to a further [Technical Difficulty] to a total of $10.2 million incremental non-dilutive cash grant funding is expected between today and December 31, 2024 from CPRIT.
In addition, the company continues to benefit from the 3 million grant from the NIH to support the GBM trial through Phase II, which is expected to be fully utilized by the end of 2024 to coincide with the completion of the ongoing Phase II trial. Based on the cash on hand and committed grant funding, our current balance sheet provides runway well into 2025. In addition, the company continues to be aggressive in the pursuit of additional NIH and separate grants to support both our current and planned future programs. Our practice will be to continue to announce those upon award. The company recognized $1.2 million of grant revenue in the third quarter of 2023 and $3.6 million year-to-date 2023. The company forecasts grant revenue of between $1 million to $1.5 million in Q4 2023 and between $6 million to $7 million for calendar year 2024.
Total operating expenses for the third quarter of 2023 decreased by $0.7 million to $4.5 million in 2023. Compared to total operating expenses of $5.2 million for the same period the prior year. The decrease is due primarily to the completion of the CGMP drug development in 2022. Other income totalling 32,000 for the quarter includes 119,000 of interest income, which fully offsets the interest expense on the remaining principal on the Oxford debt. So with the grant support our existing go-forward burn is close to 500,000 over the next 18 months. Net loss for the third quarter of 2023 was $3.2 million or $1 per share compared to a net loss of $5.2 million or $2.85 per share for the same period of the prior year. Now I'll turn it back to you Marc.
Marc Hedrick: Thank you, Andrew. Before we move on to Q&A, I'll take a moment to provide guidance on anticipated milestones over the next 14 months. First of all, in Q4, we have multiple presentations accepted at the SNO Annual Meeting, November 15 to 19 in Vancouver. We're particularly excited to present the first data cut from the ongoing Phase II GBM trial to be accompanied [Technical Difficlty] at our thought leader panel and we'll put out the specifics about that panel when finalized. Also the SNO annual meeting in November, we will also have an update on our LM trial as well. Looking beyond the SNO meeting and looking forward into 2024, we intend to complete enrollment in the Phase II ReSPECT-GBM trial and finalize a pivotal trial design with the FDA.
We also intend to complete enrollment in the Phase I ReSPECT-LM trial and begin the Phase II trial. We also intend to complete internal implementation of the CNSide cerebrospinal fluid tumor cell enumeration assay that has been currently utilized in the ReSPECT-LM clinical trial. We intend to obtain FDA IND approval and initiate the Phase I ReSPECT pediatric brain cancer trial for pediatric patients with ependymoma and high-grade glioma at the Lurie Children's Hospital in Chicago. We also will complete key development milestones for the company's next-generation radioembolic device, 188RNL-BAM. At a key second source, GMP supply chain partner to support late stage clinical trials of commercial supply and publish the ReSPECT-GBM Phase I data in a peer-reviewed publication.
Now with that I'll turn it back to Tawanda, the operator for our Q&A session.
Operator: Thank you. [Operator Instructions] Our first question comes from the line of Justin Walsh with Jones Trading. Your line is open.
Justin Walsh: Hi. Thanks for taking the questions and congrats on the progress. I’m wondering if you can provide any color on what we can expect from the presentations at SNO? I know you mentioned survival data for 15 patients, but if there’s any other info you can close ahead of the release and maybe remind us of how many patients’ worth of data we saw last time you guys presented?
Marc Hedrick: Hey, Justin, last time we presented data, there were 34 patients at a high level, 34 total patients treated in the trial. We have five abstracts accepted. Besides presenting the Phase II data set from a safety and efficacy perspective, one novel thing we’ll show is some pretty substantial updated imaging data, and that will be part of the presentation. So this will be across multiple presentations. I can’t really say any more than that as we continue to review the data. But one reason we’re having a thought leader panel is we’ll be able to bring a lot of that data that will be novel and put it into context with some of the investigators that are actually involved in patient care.
Justin Walsh: Great. Really looking forward to all that. So one more question for me. Obviously, there’s been some building momentum in the radiopharma field with M&A activity and some key data releases. Wondering if you’ve seen an increase in interest in your ongoing trials from perspective of patients, physicians and investors.
Marc Hedrick: Yes. So we’ve seen a lot of interest in our CNS radiotherapeutic assets. And I think there are several reasons for that. You mentioned one, which is there’s a renewed interest generally speaking, in the radiotherapeutic space. And Dr. LaFrance, who’s sitting with me today has been in the space for a while. And I think would tell you that it’s been a remarkable increase in interest over the last few years that he’s seen. The second thing is in the radiotherapeutic space, there’s a lot of work at preclinical. There are a number of very successful products and deals that have been announced. But there is a relative dearth of mid-stage assets. And I think that’s one reason we’ve seen a lot of interest in our technology and that we have an ongoing Phase II in GBM.
A very big indication and also LM, which is rapidly getting through the Phase I to Phase II. So that’s I think that’s created a lot of interest. And then finally, just the data itself. These are unmet medical needs that carry very high levels of mortality. There’s nothing approved for LM and there’s only been one approved drug for GBM in the last 10 years, which doesn’t improve survival. It just improves the symptomatology. So I think the combination of those three things has really created a lot of renewed interest in this space.
Justin Walsh: Great. Thanks for taking the questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Sean Lee with H.C. Wainwright. Your line is open.
Sean Lee: Good afternoon, guys, and thanks for taking my questions. First one, during the prepared remarks, you mentioned that the FDA requested additional info from both your existing studies and also for the upcoming pediatric study. Could you provide a bit more information on what was requested.
Marc Hedrick: Norman, would you like to take that?
Norman LaFrance: Hi, Sean. Thanks for the question. The FDA has always liked our approach for the dose escalation in pediatric tumors, which, as everyone knows, are not the same as adult tumors. And our plan is to do a dose escalation, not only an administered dose, but in volume. But as part of that, and as folks know FDA is very conservative, particularly around pediatric dosimetry and radiation treatment. As Marc has mentioned, we have a very well-established pulmonary database in the GBM adult trial. And what we did with FDA is review the adult dosimetry trial, review the adult safety data, which is very well tolerated and quite benign and pointing out to FDA that the — it will be an identical product administered in an identical way with the CED catheters has been quite a success story in adults.
When they got that information, they were very satisfied. We have an agreement to move forward in the protocol design and are just finishing up some minor clarifications with them, which we’ll do this quarter and to that point, we expect to start the pediatric trial early next year.
Sean Lee: Great. Thank you. That makes it much clearer. My second question is on the funding side. You mentioned that approximately $10 million additional for CPRIT next year as well, $3 million for NIH. Would that cover the majority of the expected Phase II study expenses for next year?
Andrew Sims: Thanks, Sean. So the short answer is yes. So separate funds, so let me just kind of give you a background of CPRIT then the timing. So CPRIT funds, two-thirds of all costs relating to the study. So which makes the grant extremely attractive, obviously. Currently, they cover effectively the majority of the third-party development costs, patient costs, drug costs, site initiation fees, et cetera, regulatory costs. And then they also cover significant internal costs, salaries and other overhead rent, IT, et cetera. And as we look forward and I kind of mentioned we would — we should receive over $10.2 million over the next 15 months that will cover just under 70% of the total costs.
Sean Lee: Great. My last question is just on the dose escalation study. I know previously you guys weren’t sure whether the current cohort will be the highest cohort. So I was wondering, would you go even higher in that study? And also what’s, remember, you guys also mentioned that you had a protocol for retreating patients. Is that also planned for a different cohort?
Marc Hedrick: Hi, Sean, it’s Marc. On the first question where we’ve got another couple of patients to complete 6 in cohort 8. We’re at very high radiation doses and volumes. And we’ll have to look at the data. But my guess is we won’t get to a maximum tolerated dose, but we very likely will get to a maximum feasible dose. And so data will be analyzed primarily for safety and distribution. So anyway that’s ongoing. As it relates to retreatment, so we’re in the process of putting a retreatment arm in all of our GBM sites with the idea that — and I don’t want to say too much and pre-empt some of the data at SNO. But we’re going to show imaging data that I think will be very interesting and we’ll can help provide a road map for achieving what is our primary corporate goal and that’s to turn CNS cancers into a chronic disease.
I will say that as it relates to the Phase II, if I can just editorialize a minute that I think we’re on track to complete the single administration Phase II by the end of 2024. If that data continues to look positive, we’ll present that data in the first pass of that at SNO. We may actually seek a pre-end of Phase II meeting with the FDA to discuss options for.
Sean Lee: Great. That’s all I have and thanks again for taking my questions.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Edward Woo with Ascendiant Capital. Your line is open.
Edward Woo: Yeah, congratulations on the progress. To clarify you said that Cohort 4 the LM trial was the fastest that you were able to get it filled. Is that something that you should expect going forward and does that speed up your time line at all with LM trial?
Norman LaFrance: Hi, Ed. This is Norman. Great question. And the — as I think we’ve discussed previously, there are protocol defined up [Technical Difficulty] that we agreed to with FDA because this is first-in-man intrathecal administration of, obviously, the radio activity. Given the interest that Marc alluded to earlier and a question on an earlier Q&A question, we’re getting a lot of interest on folks for the exact reason Marc mentioned that, first of all, there are really no treatments for this devastating complication. And there really are no significant active investigative trials other than ours. And we’ve gotten a very promising provocative efficacy signal in addition to being a very well-tolerated outpatient treatment.
So the short of it for the Cohorts now five through seven to be continued. We’d expect to enroll at the same rate. With that, we’d expect if there are no DLTs or other safety observations that may call the decision to end in an earlier Cohort, say, Cohort 6 will complete the full dose escalation probably by June of next year. With that, we’ll go to FDA and have an end of Phase I dose escalation and Pre-Phase II meeting and I don’t want to get too forward-looking. But given the current trend of both the safety, tolerability and preliminary efficacy will be in a position to talk to FDA about a Phase II trial that will include it being [Technical Difficulty] leading to an accelerated approval all because LM has no treatment options, is a devastating complication and not a lot of investigative.
At this point, I’ll stop there, and see if you have any other questions.
Edward Woo: Thank you very much. That was very helpful. I wish you guys good luck. Thank you.
Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.
Unidentified Analyst: Hi, guys. It’s Chad on for Jason. Sorry if it was already covered, but I was just wondering what the plans are for implementing CNSide in the LM study given that Biocept has declared bankruptcy, will you still be able to use the platform?
Marc Hedrick: Hi, Chad. Yes. So you’re right. They declared bankruptcy. We’ve been using the test for over a year and I did mention a bit in my prepared remarks, but I’ll expand on those. We didn’t really know what to expect. We started using the trial, the test, but over a year or so of experienced both with our technology and our trial and talking to the investigators, we think there’s a real opportunity with this test. We were concerned about them their solvency over the past year. And that’s why we, frankly, licensed and transferred the technology to ourselves in the weeks before they declared insolvency. So we essentially have a nonexclusive right to use the test for — in our trials with our technology and then we have an option that’s exercisable through the end of next year to gain exclusivity in the area of radiotherapeutics for this test.
So now that they’re gone, and they are gone, they’re no longer operating. We’ll be taking the protocols, the information and the testing kits that we have already acquired and are now in Texas and we’ll begin using the test, not in a CLIA fashion, but just as a research tool, so we can use in the context of our trial. Now with our option based on kind of our ongoing experience, we will actually consider whether we want to exercise that and maybe expand that. But right now, I think, the plan is just to implement it and use it in our trial and frankly CPRIT ought to pay for that as well.
Unidentified Analyst: Okay. Great. Thanks for taking the question and congrats on the progress.
Marc Hedrick: Okay. Thank you.
Operator: Thank you. I’m showing no further questions in the queue. I would now like to turn the call back over to Marc for closing remarks.
Marc Hedrick: Thank you, Tawanda. Thanks, everyone for joining us. Thanks for the good questions. Thanks for your interest in the company and we will be talking to you soon. Have a nice evening. Goodbye.
Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.
NEWS -- Plus Therapeutics to Present at the Society for NeuroOncology Annual Meeting and will Host Key Opinion Leader Webinar
Update on the ReSPECT-GBM Trial, including Phase 2, with Rhenium-186 Obisbemeda in Recurrent Glioblastoma will be Presented at SNO Annual Meeting
AUSTIN, Texas, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that it will present four posters and one oral presentation at the Society for NeuroOncology (SNO) 28th Annual Meeting being held November 15-19, 2023 in Vancouver, Canada. In addition, the Company plans to host a virtual key opinion leader (KOL) webinar after the conference, featuring Andrew Brenner, MD, PhD (Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio), to discuss new data from the Phase 2 trial of Rhenium-186 Obisbemeda in recurrent glioblastoma (rGBM) that will be presented at SNO.
SNO 28th Annual Meeting – Vancouver Convention Centre
Oral Presentation
Title: Multi-parametric MRI and SPECT Assessment of Treatment Dose and Efficacy in Respect-GBM for recurrent glioblastoma (rGBM)
Presenter: Andrew Brenner, MD, PhD
Date/Time: Saturday, November 18, 2023 at 5:05 pm – 5:10 pm PT
Location: Room 118-120
Posters – Friday, November 17, 2023 at 7:30 pm – 9:30 pm PT in Exhibit Hall A/B
Title: Update Report of the ReSPECT-GBM Phase I/IIa Dose Escalation Trial of Rhenium-186 NanoLiposome (186RNL) in Recurrent Glioma [rGBM] via Convection Enhanced Delivery (CED)
Presenter: Andrew Brenner, MD, PhD
Title: Rhenium-(Re-186)-obisbemeda [Re-186-nanoliposome] (186RNL) Phase 2 for recurrent glioblastoma (rGBM) via Convection Enhance Delivery [CED]
Presenter: Andrew Brenner, MD, PhD
Title: Rhenium (Re-186) obisbemeda{Re-186-Nanoliposome (186RNL)} in Leptomeningeal Metastases [LM] Phase 1/2a Dose Escalation Trial: Initial Safety and Feasibility
Presenter: Andrew Brenner, MD, PhD
Title: Efficacy among therapeutically effective absorbed dose patients in ReSPECT-GBM phase I of rhenium-186 nanoliposome (186RNL) in recurrent glioblastoma (rGBM) compared to an external control arm (ECA)
Presenter: Lisa Ensign, PhD
A copy of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics to Announce Third Quarter 2023 Financial Results and Host Conference Call on October 31, 2023
AUSTIN, Texas, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will report third quarter 2023 financial results on Tuesday, October 31, 2023, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
Conference Call & Webcast
Tuesday, October 31, 2023 @ 5:00 PM ET
Dial in #: https://register.vevent.com/register/BI484eba10ce0d4bc292c51db6fc396f0c
Webcast: https://edge.media-server.com/mmc/p/vt5rg89x
Participants may also pre-register any time before the call through the dial in # link. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Completes Dosing in Cohort 4 of ReSPECT-LM Phase 1 Clinical Trial of Rhenium (¹86Re) Obisbemeda in Leptomeningeal Metastases
AUSTIN, Texas, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today 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.
“The speed at which we are enrolling in the ReSPECT-LM trial reflects multiple factors, including the increasing number of patients diagnosed with LM, the lack of good therapeutic options and growing enthusiasm for the trial,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “Furthermore, significant updates on both the ReSPECT-LM and ReSPECT-GBM studies are planned for November 15-19, 2023 at the Society for Neuro-Oncology (SNO) Annual Meeting.”
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). Patients interested in learning more about the ReSPECT-LM trial can visit ClinicalTrials.gov (NCT05034497).
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
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-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 live 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).
About CNSide
CNSide is an assay based on proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize, and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer which are leading causes of LM. CNSide provides a robust quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or radiologic monitoring.
In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide. The FORESEE trial is a two-part, multicenter, prospective clinical trial expected to enroll up to 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The feasibility phase of the study is expected to complete in the first half of 2024, which will be followed by a validation phase that is estimated to include between 40 and 100 subjects.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
1 The CNSide assay is not an FDA cleared or approved assay. It is a Biocept lab developed test and its performance characteristics were determined in Biocept’s CLIA-certified, CAP-accredited laboratory.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 215-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics to Participate in the Jones Trading Healthcare Summit and ThinkEquity Conference in October
AUSTIN, Texas, Oct. 09, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that company management will attend and hold one-on-one investor meetings at the upcoming Jones Trading 2023 Healthcare Summit being held October 9-11, 2023 in Miami, FL. Marc H. Hedrick, M.D., President and Chief Executive Officer, will also present and hold one-on-one investor meetings at the upcoming ThinkEquity Conference being held on October 19, 2023 in New York, NY.
Jones Trading 2023 Healthcare Summit – October 9-11, 2023
Format: One-on-one investor meetings
Location: Eden Roc Miami Beach, Miami Beach, FL
Link: Register here
ThinkEquity Conference – October 19, 2023
Format: Corporate Presentation
Date/Time: Thursday, October 19, 2023 at 12:30-1:00pm ET
Participant: Marc H. Hedrick, M.D., President & CEO, Plus Therapeutics
Location: Mandarin Oriental, New York
Webcast: Register here
Please contact your Jones or ThinkEquity representative to schedule one-on-one meetings with the management team during the conferences.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
mailto://cdavis@lifesciadvisors.com
NEWS -- Plus Therapeutics Receives $1.9 Million Advance Payment from CPRIT and Plans to Present at the CPRIT Innovations in Cancer Prevention and Research Conference
AUSTIN, Texas, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will present data from its ReSPECT-LM clinical trial evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases at the Cancer Prevention & Research Institute of Texas (CPRIT) Innovations in Cancer Prevention and Research Conference VI. The conference is taking place October 2-3, 2023, in Galveston, Tex. The poster presentation is titled, Report of Phase 1 Part A of the ReSPECT-LM Trial: Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM).
The presentation will be showcased during the Poster Session on October 3, beginning at 7:00 a.m. A copy of the poster will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com.
In August 2023, Plus Therapeutics received an advance payment of grant funds of approximately $1.9 million, as planned, as part of its overall $17.6 million award contract, which CPRIT executed in September 2022. The contract provides for funding from CPRIT over the three-year grant period starting on August 31, 2022, and follows the expected increase of development costs as the ReSPECT-LM clinical trial progresses to later stages.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/ and https://respect-trials.com.
About the Cancer Prevention & Research Institute of Texas (CPRIT)
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention.
To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 281 distinguished researchers, supported the establishment, expansion or relocation of 52 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 8.2 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. Learn more at https://cprit.state.tx.us.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Enters into License Agreement for Cerebrospinal Fluid Tumor Cell Enumeration Assay
CNSide™ assay is the gold standard diagnostic cerebrospinal fluid (CSF) assay for patients with suspected central nervous system (CNS) cancers
As part of the agreement, Plus obtains a nonexclusive license and option for exclusivity for patients receiving CNS radiotherapy
AUSTIN, Texas, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced it has expanded its supply agreement with Biocept by acquiring an option to exclusively license Biocept's CNSide, a CSF-based tumor cell capture and enumeration platform, for patients receiving CNS radiotherapy. The option ensures that Plus Therapeutics has ongoing expanded access to the diagnostic CSF assay for patients with CNS cancers and can further develop and improve the assay specifically for patients with CNS cancers receiving radiotherapy.
“Thus far, in our ReSPECT-LM trial, we have had a very positive experience with the CNSide assay and think it has significant diagnostic potential,” said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “The announced agreement is an important building block to ensure Plus Therapeutics remains at the forefront of CNS cancer therapy.”
Under the terms of the agreement, CNSide developer, Biocept, has granted Plus Therapeutics a non-exclusive license to its CNSide cell enumeration assay for Plus’ investigational therapy for leptomeningeal metastases (LM), rhenium (186Re) obisbemeda, and an option for an exclusive license to the assay. In exchange, Plus Therapeutics will provide $150,000 of its common stock to Biocept. Prior to January 1, 2025, Plus Therapeutics will have the option for exclusivity for the field of radiotherapy in exchange for a $1.0 million payment, to be exercised at Plus Therapeutics’ discretion.
“Use of the CNSide assay has the potential to substantially improve the diagnostic paradigm for patients with solid tumor leptomeningeal disease and could provide valuable information for these patients who have limited treatment options but where a targeted therapy may be beneficial,” said Priya U. Kumthekar, M.D., Associate Professor of Neurology and Medicine at Northwestern University’s Feinberg School of Medicine. “Paired with novel investigational therapeutics such as Plus Therapeutics’ rhenium (186Re) obisbemeda, the overall clinical management of these challenging patients could be transformed.”
CNSide is an assay based on proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer and melanoma which are leading causes of LM. CNSide provides a sensitive and specific quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or imaging monitoring.
In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide. The FORESEE trial is a two-part, multicenter, prospective clinical trial expected to enroll up to 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The feasibility phase of the study is expected to complete in the first half of 2024, which will be followed by a validation phase that is estimated to include between 40 and 100 subjects.
About Leptomeningeal Metastases (LM)
LM is a rare complication of cancer in which the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM. Additionally, lung cancer, GI cancers and melanoma can also spread to the CSF and result in LM. LM occurs in approximately 5% of people with cancer and is usually terminal with 1-year and 2-year survival of just 7% and 3%, respectively. The incidence of LM is on the rise, partly because cancer patients are living longer and partly because many standard chemotherapies cannot reach sufficient concentrations in the spinal fluid to kill the tumor cells, yet there are no FDA-approved therapies specifically for LM patients, who often succumb to this complication within weeks to several months, if untreated.
About Rhenium (186Re) obisbemeda
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-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 live 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).
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
About Biocept, Inc.
Biocept, Inc. develops and commercializes molecular diagnostic assays that provide physicians with clinically actionable information for treating and monitoring patients diagnosed with a variety of cancers. Biocept has developed and is commercializing the CNSide™ cerebrospinal fluid assay that detects cancer cells that have metastasized to the central nervous system. Biocept’s patented technology captures and quantitatively analyzes CSF tumor cells for tumor-associated molecular markers. For more information, https://visit www.biocept.com.
1 The CNSide assay is not an FDA cleared or approved assay. It is a Biocept lab developed test and its performance characteristics were determined in Biocept’s CLIA-certified, CAP-accredited laboratory.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Initiates Part B of ReSPECT-LM Phase 1/2a Trial for Leptomeningeal Metastase
AUSTIN, Texas, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today 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 Phase 1/Part A data in the ReSPECT-LM clinical trial is encouraging,” said Norman LaFrance M.D., Chief Medical Officer of Plus Therapeutics. “In Phase 1/Part B, we plan to dose escalate to the maximum tolerated single dose while simultaneously collaborating with the U.S. Food and Drug Administration (FDA) to implement multiple dosing into the trial.”
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:
NEWS -- Plus Therapeutics to Present at the H.C. Wainwright 25th Annual Global Investment Conference
AUSTIN, Texas, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, will present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023 at 3:00 p.m. ET at the Lotte New York Palace in New York, NY.
Investors interested in arranging a meeting with the Company’s management during the conference should contact the H.C. Wainwright conference coordinator. An archived replay of the presentation will be available under the For Investors tab of the Plus website at https://www.plustherapeutics.com for 90 days following the event.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends, or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Reports ReSPECT-LM Phase 1 Trial Data at the 2023 SNO/ASCO CNS Cancer Conference
AUSTIN, Texas, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today reported positive data from the ReSPECT-LM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases (LM) at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference taking place August 10-12, 2023 in San Francisco, California.
“We are very encouraged by the initial safety and survival data in the ReSPECT-LM clinical trial following a single administration of a relatively low dose of rhenium (186Re) obisbemeda,” said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas Health Science Center at San Antonio and principal investigator of the ReSPECT-LM clinical trial. “Based on the Phase 1 Part A data, we believe we can substantially dose escalate and develop a multiple dosing regimen that could yield meaningful clinical benefits including a survival benefit for the extremely tough clinical problem of leptomeningeal metastases.”
“Our principal corporate goal is to dramatically improve the health and length of life of patients that have the most lethal CNS cancers,” said Marc H. Hedrick, M.D., M.B.A., President and Chief Executive Officer of Plus Therapeutics. “Similar to our promising Phase 1 and 2 data for glioblastoma, this most recent data indicates that LM, which is ten times more common than glioblastoma, may be similarly addressable with targeted radiotherapy using rhenium (186Re) obisbemeda.”
The poster presentation is titled, Preliminary Clinical Data in the Phase 1/2a Dose Escalation Trial of Rhenium (186Re) Obisbemeda (186RNL) in Leptomeningeal Metastases (LM): The ReSPECT-LM Trial [LMAP-21].
Findings in Brief:
NEWS -- Plus Therapeutics to Announce Second Quarter 2023 Financial Results and Host Conference Call on August 14, 2023
AUSTIN, Texas, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult to treat cancers, announced that the Company will report second quarter 2023 financial results on Monday, August 14, 2023, after market close. Plus Therapeutics’ management team will then host a conference call and webcast at 5:00 p.m. ET to discuss the financial results and provide a corporate update.
A live webcast will be available at https://ir.plustherapeutics.com/events.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company’s website under the ‘For Investors’ section. The webcast will be available on the Company’s website for 90 days following the live call.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Announces Key Opinion Leader Roundtable on New Clinical Trial Data Being Presented at the 2023 SNO/ASCO CNS Cancer Conference
Trial investigators and company management to discuss latest data from the ReSPECT-LM leptomeningeal metastases clinical trial
Webinar scheduled for Friday, August 11, 2023 at 8:00 a.m. ET
AUSTIN, Texas, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced a key opinion leader roundtable discussion to be held on Friday, August 11, 2023, 8:00 a.m. – 9:00 a.m. ET to discuss the latest data from the ReSPECT-LM clinical trial of rhenium (186Re) obisbemeda that will be presented at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference on August 10, 2023.
The webinar will feature a comprehensive discussion about the ongoing ReSPECT-LM Phase 1/2a dose escalation clinical trial, including key safety, tolerability, dosing, feasibility, and efficacy data. Speakers include:
NEWS -- Lineage Cell Therapeutics to Report Second Quarter 2023 Financial Results and Provide Business Update on August 10, 2023
CARLSBAD, Calif., August 03, 2023--(BUSINESS WIRE)--Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2023 financial and operating results on Thursday, August 10, 2023, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, August 10, 2023, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its second quarter 2023 financial and operating results and to provide a business update.
Interested parties may access the conference call on August 10th, 2023, by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through August 17, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 1144985.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic ("off-the-shelf") product candidates: (i) OpRegen®, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit https://www.lineagecell.com or follow the company on Twitter @LineageCell.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230803131502/en/
Contacts
Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(mailto://ir@lineagecell.com)
(442) 287-8963
LifeSci Advisors
Daniel Ferry
(mailto://daniel@lifesciadvisors.com)
(617) 430-7576
Russo Partners – Media Relations
Nic Johnson or David Schull
(mailto://Nic.johnson@russopartnersllc.com)
(mailto://David.schull@russopartnersllc.com)
(212) 845-4242
NEWS -- Plus Therapeutics to Present at the Canaccord Genuity 43rd Annual Growth Conference
AUSTIN, Texas, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, has been invited to present at the Canaccord Genuity 43rd Annual Growth Conference, on Wednesday, August 9, 2023 at 8:00 a.m. ET at the InterContinental Boston in Boston, Mass.
Investors interested in arranging a meeting with the Company’s management during the conference should contact the Canaccord Genuity conference coordinator. A webcast of the presentation can be found under the For Investors tab of the Plus website at https://www.plustherapeutics.com. A webcast replay will also be accessible for 90 days following the event.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Appoints Dr. Pius Maliakal as VP of Clinical Operations
By Daniella Parra
Plus Therapeutics (Nasdaq: PSTV) said it appointed Dr. Pius Maliakal as VP of Clinical Operations.
With over 20 years of global oncology experience, he will lead key clinical initiatives, advancing the ReSPECT-GBM and ReSPECT-LM trials for central nervous system cancers, the company said.
“Pius has a unique blend of experience in oncologic clinical development and trial operations that will make an immediate positive impact to our team,” said Marc Hedrick, M.D., President and Chief Executive Officer. “As we move our co-lead programs in glioblastoma and leptomeningeal metastases to the next clinical stages, our clinical operational team also needs to expand and advance. We are confident in Pius’ track record of clinical leadership, successful regulatory submissions, early- to late-stage trial preparation and execution with novel investigational therapeutics.”
Contact:
Healthcare Edge
mailto://Editor@Executives-edge.com
NEWS -- Plus Therapeutics Strengthens Clinical Program with the Appointment of Pius Maliakal as Vice President of Clinical Operations
AUSTIN, Texas, July 27, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today 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 Company’s 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.
“Pius has a unique blend of experience in oncologic clinical development and trial operations that will make an immediate positive impact to our team,” said Marc Hedrick, M.D., President and Chief Executive Officer. “As we move our co-lead programs in glioblastoma and leptomeningeal metastases to the next clinical stages, our clinical operational team also needs to expand and advance. We are confident in Pius’ track record of clinical leadership, successful regulatory submissions, early- to late-stage trial preparation and execution with novel investigational therapeutics.”
Dr. Maliakal added, “I’m excited to be joining the team at such an important time, and I’m eager to contribute my expertise to support ongoing pipeline development and generate a long-term clinical strategy within the Company. Based on the Company’s promising data readouts in both glioblastoma and leptomeningeal metastases, PLUS has tremendous potential to help patients with central nervous system cancers.”
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics to Present at the 2023 SNO/ASCO CNS Cancer Conference
AUSTIN, Texas, July 27, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that the Company will share three poster presentations at the Society for Neuro Oncology (SNO)/American Society of Clinical Oncology (ASCO) Central Nervous System (CNS) Cancer Conference taking place August 10-12, 2023 in San Francisco, California.
The presentations will describe new data from the ReSPECT-LM and ReSPECT-GBM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of leptomeningeal metastases (LM) and recurrent glioblastoma (rGBM), respectively, as well as details around the planned ReSPECT-PBC trial to evaluate rhenium (186Re) obisbemeda for the treatment of recurrent, refractory, or progressive childhood ependymoma and high-grade glioma (HGG).
All presentations will be showcased during the Poster Reception on Thursday, August 10, 2023, beginning at 5:30 p.m. PT/8:30 p.m. ET.
Details of presentations:
NEWS -- Plus Therapeutics to Present at the 2nd Annual Targeted Radiopharmaceuticals Summit
AUSTIN, Texas, July 13, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced that Marc Hedrick, M.D., President and Chief Executive Officer, will give two presentations at the Targeted Radiopharmaceuticals Summit taking place July 25-27, 2023 in Boston, Massachusetts.
The presentations will describe data from the ReSPECT-GBM clinical study evaluating the Company’s lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (rGBM), as well as provide an overview of the Company’s scientific approach, current pipeline and a snapshot of where it is headed.
Details of presentations:
Title
Re-186 Radiolabelled NanoLiposomes for Rare Brain & Spinal Cord Tumors
Date
July 26, 2023, 9:30 a.m. ET
Session
Targeted Radiopharmaceuticals in the US: The Past, the Present & the Future
Title
Novel Approaches to Central Nervous System Targeted Radiotherapeutics
Date
July 26, 2023, 2:30 p.m. ET
Session
Addressing TRP Toxicity: Chelators, Clearance & Drug Design
A copy of the presentations will be made available under the Presentations tab of the Investors section of the Company’s website following the meeting at https://ir.plustherapeutics.com/.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 377-4767
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
NEWS -- Plus Therapeutics Reports Positive Interim Updates from Two ReSPECT™ Clinical Trials at SNMMI Annual Meeting
Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today reported positive interim updates from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company’s lead radiotherapeutic, rhenium (186Re) 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:
NEWS -- Plus Therapeutics to Participate in the 2023 Healthcare Virtual Conference Presented by Maxim Group LLC and Hosted by M-Vest
AUSTIN, Texas, June 14, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, announced today that Marc Hedrick, M.D., President and Chief Executive Officer, has been invited to participate in a fireside chat at the 2023 Healthcare Virtual Conference, presented by Maxim Group LLC and hosted by M-Vest, on Wednesday, June 21, 2023 at 3:30 p.m. ET.
The conference will take place June 20-22, 2023, and will be hosted live on M-Vest and available under the For Investors tab of the Plus Therapeutics website at https://www.plustherapeutics.com. To attend virtually, sign up to become an M-Vest member here: Reserve Your Seat.
About Plus Therapeutics
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). The Company has built a robust supply chain through strategic partnerships that enable the development, manufacturing and future potential commercialization of its products. Plus Therapeutics is led by an experienced and dedicated leadership team and has operations in key cancer clinical development hubs including Austin and San Antonio, Texas. For more information, visit https://plustherapeutics.com/.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “designed to,” “will,” “can,” “potential,” “focus,” “preparing,” “next steps,” “possibly,” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of 186Re including the ability of 186Re to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company’s future performance including the next steps in developing the Company’s current assets; the Company’s clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM and ReSPECT-LM clinical trials; possible negative effects of 186Re; the continued evaluation of 186Re including through evaluations in additional patient cohorts; and the intended functions of the Company’s platform and expected benefits from such functions.
The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the Company’s actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: the early stage of the Company’s product candidates and therapies, the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash, the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, among others; and additional risks described under the heading “Risk Factors” in the Company’s Securities and Exchange Commission filings, including in the Company’s annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
Investor Contact
Peter Vozzo
ICR Westwicke
(443) 213-0505
mailto://Peter.Vozzo@westwicke.com
Media Contact
Terri Clevenger
ICR Westwicke
(203) 856-4326
mailto://Terri.Clevenger@westwicke.com
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