Product Development and Clinical Trials - Plus Therapeutics is developing targeted radiotherapeutics for CNS cancers, utilizing innovative drug formulations to enhance radiation delivery and minimize exposure to healthy tissues[74]. - The lead candidate, rhenium (186Re) obisbemeda, aims to treat recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancers through localized delivery methods[77]. - Interim results from the Phase 1/2a ReSPECT-GBM trial indicate that rhenium (186Re) obisbemeda can deliver up to 740 Gy of absorbed radiation to tumor tissue without significant toxicities, compared to the typical maximum of ~30-35 Gray with external beam radiation therapy[91]. - The ReSPECT-GBM trial is set to proceed to Phase 2, with a focus on further dose exploration and collecting additional safety and efficacy data[95]. - The ReSPECT-GBM Phase 2 trial has enrolled 42 patients, with a median overall survival (mOS) of 13 months, which is 63% better than the standard of care of 8 months[98]. - The median progression-free survival (mPFS) in the same trial is reported at 11 months, compared to 4 months for the standard of care[98]. - Rhenium (186Re) obisbemeda has shown a favorable safety profile, with most adverse events being mild (73.5%) or moderate (18.8%) and only 2 out of 9 severe adverse events related to the study drug[99]. - The average absorbed radiation dose to the tumor in the Phase 2 trial was 300 Gy, with 88.9% of patients meeting key drug delivery parameters correlating with overall survival[99]. - The ReSPECT-LM Phase 1 trial has treated 26 patients with no dose-limiting toxicities observed at radiation doses up to 66.14 millicuries[107]. - The company plans to submit a pediatric brain tumor IND for the ReSPECT-PBC clinical trial in the fourth quarter of 2024[115]. Regulatory and Designation Achievements - The FDA granted Orphan Drug and Fast Track designations to rhenium (186Re) obisbemeda for GBM treatment, supporting its clinical development[92]. - The FDA granted Orphan Drug designation to rhenium (186Re) obisbemeda for the treatment of patients with breast cancer with leptomeningeal metastases in November 2023[108]. Financial Performance and Funding - Grant revenue recognized was $1.5 million for the three months ended September 30, 2024, compared to $1.3 million for the same period in 2023, reflecting an increase of approximately 15.4%[127]. - Research and development expenses for the three months ended September 30, 2024, totaled $2.858 million, up from $2.493 million in the same period in 2023, an increase of approximately 14.6%[128]. - General and administrative expenses increased to $2.397 million for the three months ended September 30, 2024, from $1.998 million in the same period in 2023, representing an increase of approximately 20.0%[131]. - The company incurred net losses of $9.1 million for the nine months ended September 30, 2024, with an accumulated deficit of $489.6 million[139]. - Cash and cash equivalents decreased to $1.223 million as of September 30, 2024, down from $8.554 million as of December 31, 2023[139]. - Current liabilities increased to $12.112 million as of September 30, 2024, compared to $10.727 million as of December 31, 2023[139]. - The company expects aggregate research and development expenses to increase for the remainder of 2024 compared to the same period in 2023[130]. - The company recognized a net fair value gain on warrant liability of $1.0 million for the three months ended September 30, 2024, and $5.7 million for the nine months ended September 30, 2024[136]. - In May 2024, the company completed a private placement, issuing 3,591,532 shares and raising approximately $7.3 million in gross proceeds, with potential additional proceeds of $12.0 million if all warrants are exercised[140]. - The company received a CPRIT Grant of $17.6 million to fund two-thirds of the development costs for rhenium (186Re) obisbemeda, recognizing $4.4 million in grant revenue for the nine months ended September 30, 2024[141]. - A DoD Award was secured for $3.0 million to support the expansion of clinical trials for pediatric brain cancer, with the first payment of $0.9 million received on October 4, 2024[142]. - Under the 2022 Purchase Agreement with Lincoln Park, the company has the right to sell up to $50.0 million in shares, with 527,166 shares sold for net proceeds of approximately $3.2 million from August 2022 to December 2022[143][145]. - For the nine months ended September 30, 2024, net cash used in operating activities was $9.3 million, a decrease from $11.0 million in the same period of 2023, primarily due to increased reimbursement under the CPRIT grant[160]. - Net cash used in investing activities for the nine months ended September 30, 2024 included $0.5 million for Biocept assets and $7.1 million for short-term investments[161]. - Financing activities for the nine months ended September 30, 2024 provided net cash of $6.2 million, primarily from the May 2024 Private Placement and a $3.3 million drawdown from the Pershing Credit Facility[162]. - As of September 30, 2024, the company had $0.8 million of deferred revenue related to the CPRIT Grant[141]. Operational and Strategic Developments - Plus Therapeutics has expanded its manufacturing capabilities through a services agreement in Indiana, ensuring a robust supply chain for ongoing clinical trials[81]. - The company is focused on addressing significant unmet medical needs in treating rare and difficult-to-treat cancers, with a pipeline that includes potential applications for head and neck, ovarian, and breast cancers[80]. - The CNSide® diagnostic portfolio is being developed alongside rhenium (186Re) obisbemeda, with plans for strategic partnerships to enhance its market presence[78]. - The company is developing a novel radioembolization technology combining Rhenium NanoLiposome with Biodegradable Alginate Microsphere technology for targeted radiation delivery[119]. - The company entered into a manufacturing services agreement with SpectronRx for drug product development and manufacturing, effective January 2025[123]. - The Department of Defense has awarded $3.0 million for research and development to support the expansion of the pediatric brain cancer clinical trial[118]. - The company has ongoing cash requirements for clinical trials, regulatory approvals, and operational expansions, with no assurance of future capital raising success[152][153]. - The company reviews goodwill for impairment annually, with the test conducted in the fourth quarter[164]. - The company experienced significant volatility in its share price during the year[164]. - In May 2024, the company issued Series A and Series B Warrants, initially classified as liabilities due to their potential exercise into common stock or Pre-Funded Warrants[165]. - The balance of the warrant liability at the amendment date was $5.2 million, which was reclassified to equity following amendments made on August 9, 2024[165].

Partnership and Manufacturing Agreement - Plus Therapeutics and SpectronRx signed a Manufacturing Services Agreement (MSA) for the production of Rhenium (186Re) Obisbemeda, a targeted radiotherapy for CNS cancers [1] - The partnership aims to enhance supply chain redundancy and meet the demands of late-stage clinical trials and future commercial needs [3] - SpectronRx will utilize its state-of-the-art facilities, including over 170,000 sq ft of radiopharmaceutical contract development and manufacturing space, to produce Rhenium (186Re) Obisbemeda [2] Rhenium (186Re) Obisbemeda - Rhenium (186Re) Obisbemeda is a novel injectable radiotherapy designed to deliver targeted high-dose radiation to CNS tumors, potentially reducing off-target risks and improving patient outcomes [4] - The therapy is being evaluated in the ReSPECT-GBM and ReSPECT-LM clinical trials for recurrent glioblastoma and leptomeningeal metastases, supported by a $17.6M grant from CPRIT [4] - 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 [4] Company Overviews - Plus Therapeutics is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for CNS cancers, with lead programs in recurrent glioblastoma and leptomeningeal metastases [5] - SpectronRx is a radiopharmaceutical developer and manufacturer with expertise in radiopharmaceutical contract development, manufacturing, and isotope production, supplying products to 29 countries [6][8] - SpectronRx has over 170,000 sq ft of production space, 150 employees, and facilities in Indiana, Connecticut, and Europe, enabling it to condense timelines for bringing new medicines to market [7][8]

AUSTIN, Texas, Nov. 05, 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 third quarter 2024 financial results on Thursday, November 14, 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 re ...

AUSTIN, Texas, Aug. 08, 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 second quarter 2024 financial results on Wednesday, August 14, 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 re ...

AUSTIN, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) / American Society for Clinical Oncology (ASCO) CNS Metastases Conference August 8-10, in Denver, Colorado. "This year's SNO/ASCO Metastases confer ...

The presentation will report data from the ReSPECT-GBM and ReSPECT-LM clinical studies evaluating the Company's lead radiotherapeutic, rhenium (186Re) obisbemeda, for the treatment of recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). Session Clinical Trial Updates in Radionuclide Theranostics Investor Contact Charles Y. Huang, MBA Director of Capital Markets and Investor Relations Office: (202)-209-5751 | Direct (301)-728-7222 chuang@plustherapeutics.com Title Targeted Radiolabeled Nanoliposo ...

Greg Fuller, M.D., Ph.D., former Professor of Pathology (Neuro-Pathology) & Neuro-Radiology at The University of Texas MD Anderson Cancer Center joins Plus as Vice President of Medical Affairs and Medical Director 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 CPRIT was created by the Texas Legislature and approved by a statewide vote in 2 ...

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 c ...

Core Viewpoint - Plus Therapeutics, Inc. has granted option awards to its new Director of Capital Markets and Investor Relations, Charles Huang, to incentivize his employment with the company [1][2]. Group 1: Option Awards Details - The approved option awards allow Mr. Huang to purchase up to 5,000 shares of the company's common stock [2]. - The options will vest over four years, with one-fourth vesting on the first anniversary of the grant date and the remainder vesting in equal monthly installments [2]. - The exercise price of the options is set at the closing price of the company's common stock on the grant date, May 8, 2024 [2]. Group 2: Alignment of Interests - The company believes that these equity grants create a strong alignment of interests between Mr. Huang and the shareholders [3]. - The equity awards were granted outside of the company's 2020 Incentive Plan but have terms consistent with that plan [3]. - A Form S-8 has been filed covering these equity awards [3]. Group 3: Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system cancers [4]. - The company aims to enhance clinical outcomes for patients through a combination of image-guided local beta radiation and targeted drug delivery approaches [4]. - Plus Therapeutics has a pipeline of product candidates, with lead programs in recurrent glioblastoma and leptomeningeal metastases, and has established a supply chain through strategic partnerships [4].

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q1 2024 Earnings Conference Call May 15, 2024 5:00 PM ET Company Participants Marc Hedrick - President and Chief Executive Officer Andrew Sims - Vice President and Chief Financial Officer Norman LaFrance - Senior Vice President and Chief Medical Officer Conference Call Participants Justin Walsh - Jones Trading Edward Woo - Ascendiant Capital Sean Lee - H.C. Wainwright Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics' First Quarter 2024 Res ...