Product Development and Clinical Trials - Plus Therapeutics reported that its lead radiotherapeutic candidate, REYOBIQ™, is designed for CNS cancers, specifically targeting recurrent glioblastoma, with a potential radiation dose delivery up to 20 times greater than traditional external beam radiation therapy (EBRT) [138]. - The ReSPECT-GBM trial has enrolled 42 patients, with 19 treated at the recommended Phase 2 dose of 22.3 mCi, showing an average absorbed radiation dose to the tumor of 300 Gy [145]. - REYOBIQ™ has received both orphan drug designation and Fast Track designations from the FDA for the treatment of recurrent glioblastoma [141]. - REYOBIQ™ is under clinical investigation in a Phase 1/2 trial, with Phase 2 expected to enroll up to 34 patients and targeted for full enrollment by the end of 2025 [143]. - The ReSPECT-LM Phase 1 trial achieved full enrollment by the end of 2024, with trial closeout procedures currently underway [149]. - The ReSPECT-LM Phase 1 trial determined a recommended Phase 2 dose of 44.1 mCi with no dose-limiting toxicities observed, and one patient achieved a complete response [153]. - The company plans to begin enrollment for a ReSPECT-PBC clinical trial for pediatric brain cancer in 2025, supported by a $3.0 million DoD Award over three years [158][172]. Financial Performance and Funding - The company incurred net losses of $17.4 million for the three months ended March 31, 2025, with an accumulated deficit of $510.9 million [181]. - Cash and cash equivalents increased significantly to $9.867 million as of March 31, 2025, compared to $76,000 as of December 31, 2024 [181]. - The company raised approximately $15.0 million in gross proceeds from the March 2025 Private Placement, which closed on March 7, 2025 [187][192]. - The company recognized $1.1 million in grant revenue from the CPRIT Grant during the quarter ended March 31, 2025, part of a total grant of $17.6 million [196]. - The company has an ongoing need to raise additional cash through equity offerings, debt financings, and potential collaborations to fund future clinical development programs [209]. Research and Development - Research and development expenses decreased by approximately $1.0 million to $1.756 million for the three months ended March 31, 2025, compared to $2.763 million in the same period in 2024 [174]. - The company expects aggregate research and development expenses to remain consistent during the remainder of 2025 compared to the same period in 2024 [175]. Regulatory and Compliance - The FDA has agreed with the proposed application of cGMP guidance for REYOBIQ™, supporting ongoing and future clinical trials [135]. - Nasdaq compliance was regained on March 7, 2025, due to the March 2025 Private Placement, after previously failing to meet the Minimum Stockholders' Equity Requirement [199]. - The company received notice on May 16, 2025, for falling below the minimum bid price requirement of $1.00 per share for 30 consecutive business days [201]. - The company has until November 12, 2025, to regain compliance with the Minimum Bid Requirement, requiring a closing bid price of at least $1.00 per share for 10 consecutive business days [202]. - The company is monitoring its stock price and may consider implementing options to regain compliance with the Minimum Bid Requirement [204]. - The company has until July 21, 2025, to submit an update to its plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) due to a delay in filing its Quarterly Report [206]. Technology and Innovations - The company acquired the CNSide® Platform from Biocept, which is being utilized in the ReSPECT-LM clinical trial, and plans to reintroduce the CNSide®Test to the U.S. market in Q2 2025 [129]. - The CNSide® Test demonstrated an 80% sensitivity in detecting tumor cells compared to 29% for CSF cytology, influencing treatment decisions in over 90% of cases evaluated [170]. - The company licensed Biodegradable Alginate Microsphere technology to enhance tumor targeting capabilities and plans to develop a novel radioembolization technology using Rhenium-188 [159]. Operational Metrics - General and administrative expenses increased by $0.6 million to $2.839 million for the three months ended March 31, 2025, compared to $2.213 million in 2024 [176]. - Total share-based compensation remained consistent at $148,000 for the three months ended March 31, 2025, compared to $146,000 in 2024 [178]. - Interest income decreased to $1,000 for the three months ended March 31, 2025, down from $72,000 in 2024, primarily due to lower average cash and investment balances [179][180]. - The company reported a net cash used in operating activities of $6.2 million for the three months ended March 31, 2025, compared to $4.5 million in the same period of 2024 [215]. - Net cash provided by investing activities for the three months ended March 31, 2025, was $3.6 million, primarily from maturities of short-term investments [216]. - Financing activities generated net cash of $12.4 million for the three months ended March 31, 2025, mainly from the issuance of common stock and warrants [217]. - The company has no long-term contractual obligations other than lease obligations as of March 31, 2025 [214].
Plus Therapeutics(PSTV) - 2025 Q1 - Quarterly Report