Core Viewpoint - Plus Therapeutics reported a quarterly loss of $0.56 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.17, marking an earnings surprise of -229.41% [1] - The company has consistently missed consensus EPS estimates over the last four quarters and reported revenues of $1.06 million, missing the estimate by 42.76% [2] Financial Performance - The loss per share of $0.56 is an improvement from a loss of $0.75 per share a year ago [1] - Revenues decreased from $1.68 million in the same quarter last year to $1.06 million [2] - Plus shares have declined approximately 75.1% year-to-date, contrasting with the S&P 500's gain of 0.5% [3] Future Outlook - The company's earnings outlook is crucial for investors, with current consensus EPS estimates at -$0.17 for the next quarter and -$0.67 for the current fiscal year [7] - The estimate revisions trend for Plus is currently favorable, resulting in a Zacks Rank 2 (Buy), indicating expected outperformance in the near future [6] - The Medical - Drugs industry, to which Plus belongs, is ranked in the top 28% of Zacks industries, suggesting a positive industry outlook [8]

Financial Performance - The net loss for Q1 2025 was $17.4 million, or $(1.19) per share, compared to a net loss of $3.3 million, or $(0.75) per share, for the same period in the prior year[10]. - Total operating loss for Q1 2025 was $3.5 million, slightly higher than the $3.3 million loss in the same period of 2024[10]. - Net loss for Q1 2025 was $17,401,000, compared to a net loss of $3,261,000 in Q1 2024, representing a significant increase in losses[20]. - Net cash used in operating activities for Q1 2025 was $6,172,000, up from $4,513,000 in Q1 2024[20]. - Cash paid for interest during Q1 2025 was $539,000, a significant increase from $23,000 in Q1 2024[20]. Cash Position - The cash balance increased to $9.9 million at March 31, 2025, compared to $0.1 million at December 31, 2024[10]. - Cash and cash equivalents at the end of Q1 2025 were $9,867,000, compared to $2,901,000 at the end of Q1 2024, indicating a substantial increase[20]. - The company experienced a net increase in cash and cash equivalents of $9,791,000 in Q1 2025, compared to a decrease of $5,653,000 in Q1 2024[20]. - Net cash provided by financing activities in Q1 2025 was $12,405,000, compared to a net cash used of $776,000 in Q1 2024[20]. - The company recorded a change in fair value of derivative instruments amounting to $9,143,000 in Q1 2025, with no comparable figure in Q1 2024[20]. Grants and Financing - The company raised gross proceeds of $15 million in a private placement financing and received a $2 million grant award advance from CPRIT to accelerate the development of REYOBIQ for the leptomeningeal metastases program[5]. - The company recognized $1.1 million in grant revenue in Q1 2025, a decrease from $1.7 million in Q1 2024[10]. Clinical Development - The company presented updated interim data on REYOBIQ at a conference, highlighting safety and clinical benefits in patients with leptomeningeal metastases[5]. - REYOBIQ has shown a median overall survival of 17 months for patients receiving a radiation dose greater than 100 Gy, more than double the standard of care for recurrent glioblastoma[5]. - The company completed the ReSPECT-LM Phase 1 trial and determined the maximum tolerated and recommended Phase 2 dose[5]. Management and Team - The company strengthened its management team with key appointments, including Dr. Michael Rosol as Chief Development Officer and Russell Bradley as President of CNSide Diagnostics[10]. - The company plans to commercialize the CNSide™ CSF assay platform in the U.S. in 2025[11]. Other Financial Activities - The company issued notes payable and warrants totaling $3,738,000 in Q1 2025, with no issuance reported in Q1 2024[20]. - The company reported a redemption of short-term investments amounting to $3,531,000 in Q1 2025, compared to a redemption of $324,000 in Q1 2024[20]. - The company had a supplemental disclosure of non-cash investing and financing activities, including an exchange of warrants for notes payable valued at $3,694,000 in Q1 2025[20].

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].

Core Insights - Plus Therapeutics, Inc. is advancing its clinical trials for REYOBIQ™ and preparing for the launch of the CNSide® CSF assay platform, with a focus on central nervous system cancers [1][2] Financial Overview - The cash balance increased to $9.9 million as of March 31, 2025, compared to $0.1 million at December 31, 2024 [6] - The company raised gross proceeds of $15 million through private placement financing and received a $2 million grant from CPRIT to support the development of REYOBIQ™ [7] - Grant revenue for Q1 2025 was $1.1 million, down from $1.7 million in Q1 2024 [13] - The total operating loss for Q1 2025 was $3.5 million, slightly higher than the $3.3 million loss in the same period of 2024 [13] - The net loss for Q1 2025 was $17.4 million, or $(1.19) per share, compared to a net loss of $3.3 million, or $(0.75) per share, in Q1 2024 [13][18] Clinical Development Highlights - REYOBIQ™ is being evaluated for recurrent glioblastoma and leptomeningeal metastases in ongoing clinical trials [9] - Updated interim data presented at a conference in May 2025 indicated safety and clinical benefits of REYOBIQ™ for patients with leptomeningeal metastases [7] - Phase 1 trial results published in Nature Communications showed that patients receiving a radiation dose greater than 100 Gy had a median overall survival of 17 months, more than double the standard of care [7] Management and Strategic Developments - The company strengthened its management team with key appointments, including Kyle Guse to the Board of Directors and Dr. Michael Rosol as Chief Development Officer [7] - Russell Bradley was appointed as President and General Manager of CNSide Diagnostics, focusing on the commercialization of the CSF assay platform [7] Product and Technology Overview - REYOBIQ™ is a novel injectable radiotherapy designed for targeted delivery of high-dose radiation to CNS tumors, potentially improving patient outcomes compared to existing therapies [9] - CNSide Diagnostics is developing the CNSide™ CSF assay platform to identify tumor cells in cerebrospinal fluid, with plans for commercialization in the U.S. in 2025 [10]

Core Viewpoint - Plus Therapeutics, Inc. has received a delinquency notification from Nasdaq due to the delayed filing of its Quarterly Report for the period ended March 31, 2025, but this does not immediately affect its listing status on Nasdaq [1][2]. Group 1: Compliance and Filing Status - The Company must submit a plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) by July 21, 2025 [2]. - If the compliance plan is accepted, Nasdaq may grant an extension of up to 180 calendar days, allowing the Company until November 17, 2025, to regain compliance [2]. - The Company is actively working to file the Quarterly Report as soon as possible and aims to return to a normal filing schedule for the remainder of 2025 [2]. Group 2: Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company based in Houston, Texas, focused on developing targeted radiotherapeutics for challenging cancers of the central nervous system [3]. - The Company employs a combination of image-guided local beta radiation and targeted drug delivery methods, with key programs targeting leptomeningeal metastases and recurrent glioblastoma [3]. - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [3].

Core Viewpoint - Plus Therapeutics (PSTV) is anticipated to report a year-over-year increase in earnings driven by higher revenues, with a consensus outlook suggesting a quarterly loss of $0.17 per share, reflecting a 77.3% improvement compared to the previous year, and revenues expected to reach $1.85 million, up 10.1% from the same quarter last year [1][3]. Earnings Expectations - The stock may experience upward movement if the reported earnings exceed expectations, while a miss could lead to a decline in stock price [2]. - Management's commentary during the earnings call will significantly influence the sustainability of any immediate price changes and future earnings expectations [2]. Estimate Revisions - The consensus EPS estimate has been revised 31.25% higher in the last 30 days, indicating a collective reassessment by analysts [4]. - A positive Earnings ESP reading is a strong predictor of an earnings beat, especially when combined with a favorable Zacks Rank [8]. Earnings Surprise Prediction - The Most Accurate Estimate for Plus is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -45.46%, suggesting a bearish outlook from analysts [10]. - Despite the negative Earnings ESP, Plus holds a Zacks Rank of 2, complicating predictions regarding an earnings beat [11]. Historical Performance - In the last reported quarter, Plus was expected to post a loss of $0.51 per share but actually reported a loss of $0.67, resulting in a surprise of -31.37% [12]. - The company has not surpassed consensus EPS estimates in any of the last four quarters [13]. Conclusion - Plus does not appear to be a compelling candidate for an earnings beat, and investors should consider additional factors when deciding on their investment strategy ahead of the earnings release [16].

Core Insights - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers [3] - The company will participate in the D. Boral Capital Inaugural Global Conference on May 14, 2025, in New York City [1] - Marc H. Hedrick, M.D., the President and CEO, will host one-on-one meetings during the conference [2] Company Overview - Plus Therapeutics is headquartered in Houston, Texas, and is developing advanced therapies for difficult-to-treat CNS cancers, including leptomeningeal metastases and recurrent glioblastoma [3] - The company utilizes image-guided local beta radiation combined with targeted drug delivery to enhance clinical outcomes [3] - Plus Therapeutics has established a supply chain through strategic partnerships for the development, manufacturing, and potential commercialization of its products [3] Subsidiary Information - CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, focuses on developing proprietary laboratory tests to identify tumor cells that have metastasized to the CNS [4] - The CNSide™ CSF Assay Platform allows for quantitative analysis and molecular characterization of tumor cells in cerebrospinal fluid, aiding in the management of patients with leptomeningeal metastases [4] - CNSide™ is planned for commercialization in the U.S. in 2025 [4]

Core Insights - Plus Therapeutics, Inc. has appointed Kyle Guse, J.D., M.B.A. to its Board of Directors, where he will chair the Audit Committee and serve on the Compensation Committee [1][2] - Guse brings over 30 years of experience in financial, transactional, and operational roles, including significant positions at Atossa Therapeutics, Inc. and DDC Enterprise Ltd. [2][3] - The company is focused on developing targeted radiotherapeutics for central nervous system cancers, with products like REYOBIQ™ and CNSide, aiming to enhance clinical outcomes [4] Company Overview - Plus Therapeutics is a clinical-stage pharmaceutical company headquartered in Houston, Texas, specializing in targeted radiotherapeutics for challenging CNS cancers [4] - The company combines image-guided local beta radiation with targeted drug delivery approaches, advancing a pipeline that includes programs for leptomeningeal metastases and recurrent glioblastoma [4] - Plus Therapeutics has established a supply chain through strategic partnerships to support the development, manufacturing, and potential commercialization of its products [4]

Core Insights - Plus Therapeutics, Inc. is advancing its lead compound REYOBIQ™ for treating central nervous system cancers, with new data to be presented at an upcoming conference [1][4] Group 1: Clinical Data and Results - The abstract presented at the Nuclear Medicine and Neurooncology conference highlights data from the Phase 1 ReSPECT-LM trial, showing a dose-dependent increase in absorbed radiation dose, reaching 253Gy in Cohort 5 [2] - Among 16 patients evaluated, 5 (31%) exhibited a partial response, while 7 patients showed stable disease, resulting in a Clinical Benefit Rate of 75% [2] - Physician evaluations indicated a decrease in disease findings in 2 of 14 patients (14%), with 10 patients maintaining stable findings, leading to an 86% Clinical Benefit Rate [2] - No dose-limiting toxicity was observed in the first four cohorts, with a grade 4 DLT (thrombocytopenia) noted in Cohorts 5 and 6 [2] Group 2: Mechanism and Potential - RNA sequencing of leptomeningeal metastases (LM) cells indicated early apoptosis induction and an immune response, with T cell increase by Day 28 [3] - REYOBIQ™ is designed to deliver targeted high-dose radiation effectively, potentially improving outcomes for CNS cancer patients compared to existing therapies [6] Group 3: Background on Leptomeningeal Metastases - Leptomeningeal Metastases (LM) is a severe complication of cancer, affecting approximately 5% of cancer patients, often leading to terminal outcomes [5] - There are currently no FDA-approved therapies specifically for LM, highlighting a significant unmet medical need [5] Group 4: Company Overview - Plus Therapeutics is focused on developing targeted radiotherapeutics for challenging CNS cancers, with a pipeline that includes programs for LM and recurrent glioblastoma [7] - The company has established a supply chain through strategic partnerships to support the development and potential commercialization of its products [8]

Core Viewpoint - Plus Therapeutics (PSTV) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1][2]. - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to buying or selling actions that affect stock prices [4]. Company Performance Indicators - The upgrade for Plus indicates an improvement in the company's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. - Plus is expected to earn -$0.99 per share for the fiscal year ending December 2025, representing a year-over-year change of 57.7% [8]. - Over the past three months, the Zacks Consensus Estimate for Plus has increased by 37.9%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - The upgrade of Plus to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].