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].

Part I [Business](index=9&type=section&id=Item%201.%20Business) The company develops targeted radiotherapeutics for CNS cancers, led by its REYOBIQ™ candidate and supported by the CNSide® diagnostic platform - Plus Therapeutics is a U.S. pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers using novel radioactive drug formulations and medical devices[24](index=24&type=chunk) - The company's lead radiotherapeutic candidate is **REYOBIQ™** (rhenium (186Re) obisbemeda), designed for CNS cancers like recurrent glioblastoma (GBM), leptomeningeal metastases (LM), and pediatric brain cancers (PBC)[27](index=27&type=chunk) - In April 2024, the company **acquired the CNSide® Platform**, a cerebrospinal fluid cancer diagnostic portfolio, and formed a wholly owned subsidiary, CNSide Diagnostics, LLC, to manage it[28](index=28&type=chunk) [Pipeline](index=9&type=section&id=Pipeline) The clinical pipeline is centered on REYOBIQ™ trials for various brain cancers and the preclinical 188RNL-BAM for solid organ cancers - The lead investigational drug, **REYOBIQ™**, has received conditional acceptance of its proprietary name from the FDA and is being developed for GBM, LM, and PBC[30](index=30&type=chunk) - The ReSPECT-GBM Phase 1 trial is complete, and **Phase 2 is enrolling patients**, with full enrollment targeted by the end of 2025[39](index=39&type=chunk)[40](index=40&type=chunk)[45](index=45&type=chunk) - The ReSPECT-LM Phase 1 trial was completed in February 2025, establishing a recommended Phase 2 dose and supported by a **$17.6 million CPRIT grant**[44](index=44&type=chunk)[46](index=46&type=chunk)[50](index=50&type=chunk) - A Phase 1 trial for pediatric brain cancer (ReSPECT-PBC) is planned to begin enrollment in the first half of 2025, supported by a **$3.0 million Department of Defense award**[54](index=54&type=chunk) - The preclinical **188RNL-BAM technology** is being developed as a radioembolization therapy for solid organ cancers, with an initial target of liver cancer[55](index=55&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) - The CNSide™ Test demonstrated **over double the diagnostic sensitivity** of standard cytology and is planned for U.S. market re-introduction in Q2 2025[58](index=58&type=chunk)[59](index=59&type=chunk) [Licensing](index=17&type=section&id=Licensing) The company's core technologies are secured through exclusive licensing agreements with milestone and royalty payment structures - The company holds an exclusive, perpetual license from UTHSCSA for the BAM technology, with financial terms based on **clinical, regulatory, and sales milestones**[60](index=60&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) - An exclusive license for the REYOBIQ™ platform was acquired from NanoTx, including upfront payments, future milestones, and **15% of non-dilutive grants**[67](index=67&type=chunk)[68](index=68&type=chunk) [Competition](index=21&type=section&id=Competition) The company faces intense competition from large, well-resourced pharmaceutical and biotech firms across all its target indications - The company faces intense competition from numerous domestic and multinational companies, academic institutions, and research organizations[72](index=72&type=chunk) - Key competitors include **AstraZeneca, Novartis, and Bristol Myers Squibb** for recurrent glioblastoma and **Boston Scientific and SIR-TEX** for liver radioembolization[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) [Intellectual Property](index=21&type=section&id=Intellectual%20Property) Success depends on a portfolio of licensed and co-owned patents for its key technologies, with expirations from 2025 through the 2040s - The primary U.S. patent covering REYOBIQ™ expires in December 2026, but the company plans to apply for a **patent term extension of up to five years**[80](index=80&type=chunk)[82](index=82&type=chunk) - 188RNL-BAM is covered by licensed patent families with expected **expiration dates in 2040 and 2042**[83](index=83&type=chunk)[84](index=84&type=chunk) - The company co-owns patent families for methods of treating cancer with its nanoliposome technology, with expected **expiration dates in 2041 and 2043**[85](index=85&type=chunk)[86](index=86&type=chunk) - The CNSide™ Platform is protected by a broad portfolio of owned patents with **expiration dates ranging from 2025 to 2041**[88](index=88&type=chunk)[92](index=92&type=chunk) [Government Regulation and Product Approval](index=25&type=section&id=Government%20Regulation%20and%20Product%20Approval) Products are subject to extensive and stringent regulation by the FDA and other authorities, covering drugs, devices, and diagnostics - The company's products are extensively regulated by the FDA and other global authorities, covering all stages from development to marketing[89](index=89&type=chunk) - The FDA is phasing out enforcement discretion for Laboratory Developed Tests (LDTs), which may subject the **CNSide™ Test to more rigorous medical device regulations**[90](index=90&type=chunk)[297](index=297&type=chunk) - The company has received **Fast Track and Orphan Drug designations** for REYOBIQ™, providing potential for accelerated review and market exclusivity[37](index=37&type=chunk)[43](index=43&type=chunk)[48](index=48&type=chunk) - Activities are subject to healthcare laws like the **Anti-Kickback Statute and False Claims Act**, regulating interactions with providers and payors[147](index=147&type=chunk)[148](index=148&type=chunk)[150](index=150&type=chunk) [Risk Factors](index=55&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, regulatory, and intellectual property risks that could impact its viability [Risks Related to Financial Position and Capital Requirements](index=55&type=section&id=Risks%20Related%20to%20our%20Financial%20Position%20and%20Capital%20Requirements) A history of losses and a working capital deficit raise substantial doubt about the company's ability to continue as a going concern - The company has incurred losses since inception and expects them to continue, with an **accumulated deficit of $493.5 million** as of December 31, 2024[200](index=200&type=chunk) - There is **substantial doubt about the company's ability to continue as a going concern** due to its history of losses and insufficient liquidity[204](index=204&type=chunk) - The company faces the **risk of delisting from Nasdaq** for failure to meet minimum stockholders' equity requirements, though it regained compliance in March 2025[207](index=207&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk) - **Substantial additional funding is required** to continue operations, and failure to secure it may force program delays or eliminations[214](index=214&type=chunk) [Risks Related to Business and Industry](index=62&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) Success depends on developing its lead candidates and monetizing new assets amid regulatory uncertainty and intense competition - The company's future success is largely dependent on the **successful development and commercialization of REYOBIQ™ and 188RNL-BAM**[232](index=232&type=chunk) - 188RNL-BAM will be regulated as a medical device by the FDA, introducing **complex and lengthy regulatory pathways**[234](index=234&type=chunk)[235](index=235&type=chunk) - The acquisition of the CNSide™ Portfolio presents integration challenges, and **changing LDT regulations could impose more stringent requirements**[239](index=239&type=chunk)[240](index=240&type=chunk) - Reliance on government funding from CPRIT and the DoD imposes **restrictive covenants and potential repayment obligations**[251](index=251&type=chunk)[254](index=254&type=chunk)[257](index=257&type=chunk) - The company faces intense competition from **larger companies with greater resources**, and its products may not be able to compete effectively[258](index=258&type=chunk)[259](index=259&type=chunk) - **Product development is a lengthy, expensive, and uncertain process**, and positive early-stage data is not predictive of future success[264](index=264&type=chunk)[269](index=269&type=chunk) [Risks Relating to Intellectual Property](index=95&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) The company's success is contingent on obtaining and defending its intellectual property rights in an uncertain legal landscape - The company's success depends on its ability to **obtain, maintain, and defend patent, trademark, and trade secret protection**[350](index=350&type=chunk) - The patent landscape is highly uncertain, and **changes in patent law could diminish the value** of the company's intellectual property[352](index=352&type=chunk) - The company may not be able to adequately protect its trade secrets, as **confidential information could be disclosed to competitors**[356](index=356&type=chunk) - The company may incur **substantial costs from litigation** related to intellectual property rights, either to enforce its patents or defend against infringement claims[358](index=358&type=chunk)[363](index=363&type=chunk) [Risks Relating to Capital Stock and Securities Markets](index=99&type=section&id=Risks%20Relating%20to%20the%20Issuances%20of%20Capital%20Stock%2C%20the%20Securities%20Markets%20and%20an%20Investment%20in%20our%20Common%20Stock) Investors face risks of substantial dilution from future equity issuances and outstanding warrants, alongside stock price volatility - Stockholders may experience **substantial dilution** from future issuances of capital stock needed to fund operations[366](index=366&type=chunk)[367](index=367&type=chunk) - Outstanding warrants contain provisions for **exercise price resets and cashless exercise features** that could result in substantial additional dilution[369](index=369&type=chunk)[370](index=370&type=chunk)[374](index=374&type=chunk) - The large number of shares underlying outstanding warrants **may depress the market price** of the common stock if sold[377](index=377&type=chunk) - The company's common stock price is volatile, and it **does not intend to pay cash dividends** in the foreseeable future[378](index=378&type=chunk)[386](index=386&type=chunk) [Cybersecurity](index=104&type=section&id=Item%201C.%20Cybersecurity) The company has implemented a cybersecurity program and incident response plan, with oversight from the Board and a third-party consultant - The company has a cybersecurity program with safeguards such as password protection, multi-factor authentication, and monitoring systems[391](index=391&type=chunk) - Cybersecurity risk management is overseen by a third-party consultant (ITFD) who reports to the CFO, with **ultimate oversight from the Board of Directors**[395](index=395&type=chunk)[396](index=396&type=chunk) - The company maintains a Data Breach Response Policy and an Incident Response Plan to manage potential cybersecurity incidents[393](index=393&type=chunk) - As of the report date, the company is not aware of any cybersecurity threats that have **materially affected its business, operations, or financial condition**[399](index=399&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=107&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under the symbol "PSTV", and the company does not anticipate paying cash dividends - The company's common stock trades on the Nasdaq Capital Market under the symbol 'PSTV'[404](index=404&type=chunk) - The company has never paid cash dividends and **does not intend to pay them** in the foreseeable future[405](index=405&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=108&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a $13.0 million net loss for 2024 and faces a going concern risk, relying on grant funding and private placements for liquidity [Results of Operations](index=118&type=section&id=Results%20of%20Operations) The company's 2024 operating loss widened to $14.7 million on increased R&D and G&A expenses, despite higher grant revenue Comparison of Operations (in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Grant Revenue | $5,824 | $4,913 | | Research and Development Expenses | $10,580 | $9,690 | | General and Administrative Expenses | $9,939 | $8,544 | | **Operating Loss** | **$(14,695)** | **$(13,321)** | | Other Income (Expense) | $1,717 | $5 | | **Net Loss** | **$(12,978)** | **$(13,316)** | - Grant revenue increased to **$5.8 million** in 2024 from $4.9 million in 2023, primarily from the CPRIT grant[455](index=455&type=chunk) - R&D expenses increased by **$0.9 million** in 2024 due to higher development expenses and professional service fees[460](index=460&type=chunk) - G&A expenses increased by **$1.4 million** in 2024, mainly due to a $1.0 million increase in legal and professional expenses[462](index=462&type=chunk) - The company recognized a net fair value gain on warrant liability of **$5.7 million** and a financing expense of **$3.5 million**[467](index=467&type=chunk) [Liquidity and Capital Resources](index=122&type=section&id=Liquidity%20and%20Capital%20Resources) With a $10.3 million working capital deficit, the company's ability to continue as a going concern depends on recent financing and grant funding Key Liquidity Measures (in thousands) | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $76 | $8,554 | | Current assets | $5,259 | $9,834 | | Current liabilities | $15,551 | $10,727 | | **Working capital deficit** | **$(10,292)** | **$(893)** | - The company's net loss of $13.0 million and net cash used in operations of $10.6 million for 2024 contribute to **substantial doubt about its ability to continue as a going concern**[471](index=471&type=chunk) - In May 2024, the company raised net proceeds of approximately **$7.3 million** through a private placement[473](index=473&type=chunk) - Subsequent to year-end, the company raised approximately **$15.0 million in gross proceeds** from a private placement in March 2025[477](index=477&type=chunk)[482](index=482&type=chunk)[485](index=485&type=chunk) - The company is supported by a **$17.6 million CPRIT grant** and a **$3.0 million DoD award**[486](index=486&type=chunk)[487](index=487&type=chunk) [Critical Accounting Estimates](index=128&type=section&id=Critical%20Accounting%20Estimates) Key estimates involve significant judgment in the valuation of warrant liabilities, grant revenue recognition, and goodwill impairment testing - **Warrant Liability**: Warrants are classified as liabilities and remeasured to fair value each period, with changes recognized in the statement of operations[511](index=511&type=chunk) - **Grants and Awards**: Government grants are recognized as revenue when the company incurs the related allowable expenses under the contract[514](index=514&type=chunk) - **Impairment of Goodwill**: Goodwill is tested for impairment annually, and the 2024 evaluation determined no impairment existed[516](index=516&type=chunk)[517](index=517&type=chunk) - **Share-based Compensation**: The company uses the Black-Scholes model to estimate the fair value of stock option awards, requiring subjective assumptions[518](index=518&type=chunk) [Financial Statements and Supplementary Data](index=133&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The auditor's report highlights a going concern uncertainty, with financial statements showing a net loss of $13.0 million and a stockholders' deficit - The independent auditor's report expresses an opinion that the financial statements are fairly presented but includes a paragraph highlighting **substantial doubt about the company's ability to continue as a going concern**[522](index=522&type=chunk)[523](index=523&type=chunk) Consolidated Balance Sheet Summary (in thousands) | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Total Current Assets | $5,259 | $9,834 | | **Total Assets** | **$6,633** | **$11,388** | | Total Current Liabilities | $15,551 | $10,727 | | **Total Liabilities** | **$15,582** | **$12,736** | | **Total Stockholders' Equity (Deficit)** | **$(8,949)** | **$(1,348)** | Consolidated Statement of Operations Summary (in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Grant Revenue | $5,824 | $4,913 | | Total Operating Expenses | $20,519 | $18,234 | | **Net Loss** | **$(12,978)** | **$(13,316)** | | **Net Loss Per Share (basic)** | **$(1.95)** | **$(4.24)** | Consolidated Cash Flow Summary (in thousands) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,554) | $(12,851) | | Net cash used in investing activities | $(4,111) | $(160) | | Net cash provided by financing activities | $6,187 | $3,445 | | **Net decrease in cash** | **$(8,478)** | **$(9,566)** | [Controls and Procedures](index=172&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of year-end 2024 - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2024[696](index=696&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's **internal control over financial reporting was effective** as of December 31, 2024[698](index=698&type=chunk) Part III [Directors, Executive Compensation, Security Ownership, and Principal Accountant Fees](index=174&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%20and%2014) Required information on directors, compensation, and ownership is incorporated by reference from the forthcoming 2025 Proxy Statement - Information regarding directors, executive officers, corporate governance, executive compensation, security ownership, related transactions, and accountant fees is **incorporated by reference from the company's forthcoming 2025 Proxy Statement**[707](index=707&type=chunk)[708](index=708&type=chunk)[709](index=709&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=175&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements and provides an index of all exhibits filed with or incorporated into the annual report - This section contains the list of financial statements filed with the report and an **index of all exhibits**, such as material contracts and certifications[714](index=714&type=chunk)[716](index=716&type=chunk)[717](index=717&type=chunk)

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2024 Earnings Conference Call March 27, 2025 5:00 PM ET Company Participants Marc Hedrick - President and CEO Andrew Sims - CFO Conference Call Participants Edward Woo - Ascendiant Capital Sean Lee - H.C. Wainwright Operator Good afternoon, ladies and gentlemen. Welcome to Plus Therapeutics' Fourth Quarter and Full Year 2024 Results Conference Call. Before we begin, we want to advise you that over the course of the call, including any question-and-answer session, for ...

Core Insights - Plus Therapeutics reported a quarterly loss of $0.67 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.51, representing an earnings surprise of -31.37% [1] - The company generated revenues of $1.41 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 6.49% and showing a slight increase from $1.31 million a year ago [2] - Plus shares have increased by approximately 27.8% since the beginning of the year, contrasting with a -2.9% decline in the S&P 500 [3] Company Outlook - The future performance of Plus Therapeutics will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][5] - Current consensus EPS estimate for the upcoming quarter is -$0.36 on revenues of $1.7 million, while for the current fiscal year, it is -$1.60 on revenues of $5.4 million [7] - The estimate revisions trend for Plus is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which Plus belongs, is currently ranked in the top 31% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Indivior PLC, is expected to report quarterly earnings of $0.22 per share, reflecting a year-over-year decline of 40.5% [9]

PLUS THERAPEUTICS, Inc. (PSTV) Q4 2024 Earnings Conference Call March 27, 2025 05:00 PM ET Company Participants Sherry - Conference Call ModeratorDr. Mark Hedrick - President and Chief Executive OfficerAndrew Sims - Chief Financial OfficerEdward Wu - Accedient Capital (Caller)Jason Colbert - Deep World Capital (Caller - via Lindsay)Sean Lee - HC Wainwright (Caller) Dr. Mark Hedrick Final remarks, so after Q&A, just turn it back to me for a few seconds, please. Sherry Good afternoon, ladies and gentlemen. We ...

[Plus Therapeutics Q4 and Full Year 2024 Report](index=1&type=section&id=Plus%20Therapeutics%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202024%20Financial%20Results%20and%20Recent%20Business%20Highlights) Plus Therapeutics' Q4 and full year 2024 report details financial results, strategic financing, advancements in REYOBIQ and CNSide programs, and upcoming milestones [Q4 2024 & Recent Highlights and Milestones](index=1&type=section&id=Q4%202024%20%26%20RECENT%20HIGHLIGHTS%20AND%20MILESTONES) In Q4 2024 and early 2025, Plus Therapeutics secured $15.0 million in financing, extending its operational runway into 2026 and regaining Nasdaq compliance. The company advanced its lead drug, REYOBIQ, with FDA brand name approval, Orphan Drug Designation for leptomeningeal metastases (LM), and positive Phase 1 data publication. Its diagnostic platform, CNSide, also showed positive utility data, with a full commercial launch planned for 2025. Key leadership appointments were made to support these developments [Corporate Highlights](index=1&type=section&id=Corporate) Corporate highlights include securing $15.0 million in financing, obtaining a $2.0 million grant advance, and strengthening the management team with key appointments - Raised **$15.0 million** in a private placement, extending the company's financial runway into 2026 and ensuring compliance with Nasdaq's minimum stockholders' equity requirement[5](index=5&type=chunk) - Obtained a **$2.0 million** grant advance from its existing **$17.6 million** CPRIT grant to accelerate the development of REYOBIQ for leptomeningeal metastases (LM)[5](index=5&type=chunk) - Strengthened the management team with key appointments: Dr. Michael Rosol as Chief Development Officer, Mr. Russell Bradley as President and GM of CNSide Diagnostics, and Dr. Jonathan Stein as Medical Director for CNSide Diagnostics[5](index=5&type=chunk) [REYOBIQ Program Highlights](index=1&type=section&id=REYOBIQ) REYOBIQ program highlights include FDA brand name approval, positive Phase 1 data publication, Orphan Drug Designation for LM, and completion of the ReSPECT-LM Phase 1 trial - Received U.S. FDA agreement for the brand name REYOBIQ (Rhenium Re 186 Obisbemeda)[5](index=5&type=chunk) - Published Phase 1 results for recurrent glioblastoma (GBM) in Nature Communications, showing a median overall survival of **17 months** for patients receiving a radiation dose **>100 Gy**, more than **double** the standard of care[5](index=5&type=chunk) - Granted U.S. FDA Orphan Drug Designation for REYOBIQ for treating LM in lung cancer patients[5](index=5&type=chunk) - Completed the ReSPECT-LM Phase 1 single-dose trial and determined the recommended Phase 2 dose[8](index=8&type=chunk) - Expanded strategic agreement with Telix IsoTherapeutics Group to ensure a reliable supply of cGMP Rhenium-186 for late-stage trials and commercialization[8](index=8&type=chunk) [CNSide Diagnostic Platform Highlights](index=2&type=section&id=CNSide) CNSide diagnostic platform highlights include positive clinical trial data presentation and the planned full commercial launch in 2025 - Presented positive data from the FORESEE clinical trial and real-world studies, demonstrating the utility of the CNSide assay platform in diagnosing and managing patients with LM[8](index=8&type=chunk) - The full commercial launch of the CNSide diagnostic platform is on track for **2025**, which is expected to make Plus Therapeutics an operational revenue-generating company[2](index=2&type=chunk)[8](index=8&type=chunk) [Upcoming Expected Events and Milestones](index=2&type=section&id=UPCOMING%20EXPECTED%20EVENTS%20AND%20MILESTONES) The company anticipates a series of key milestones in 2025, including presentations at major medical conferences, completion of enrollment for multiple clinical trials (ReSPECT-LM and ReSPECT-GBM), an end-of-Phase 1 meeting with the FDA for the ReSPECT-LM trial, and obtaining IND approval for a new pediatric brain cancer trial (ReSPECT-PBC) in the second half of the year - Key upcoming milestones for 2025 include: * Presentations at the NMN Symposium (**May 2025**) and SNO/ASCO CNS Metastases Conference (**August 2025**) * Complete enrollment of Cohort 1 in the ReSPECT-LM Phase 1 multiple dose trial * Complete end-of-Phase 1 meeting with the U.S. FDA for the ReSPECT-LM trial * Complete ReSPECT-GBM Phase 2 enrollment * Obtain IND approval for the ReSPECT-PBC Phase 1/2 trial for pediatric brain tumors in **H2 2025**[8](index=8&type=chunk) [Full Year 2024 Financial Results Summary](index=2&type=section&id=FULL%20YEAR%202024%20FINANCIAL%20RESULTS) For the full year 2024, Plus Therapeutics reported grant revenue of $5.8 million, an increase from $4.9 million in 2023. The operating loss widened to $14.7 million from $13.3 million year-over-year, primarily due to increased R&D expenses for the ReSPECT-LM trial. The net loss was $13.0 million, or $(1.95) per share, compared to a net loss of $13.3 million, or $(4.24) per share, in 2023. The company's cash and investments stood at $3.6 million at year-end Full Year 2024 vs. 2023 Financial Highlights | Financial Metric | 2024 | 2023 | | :--- | :--- | :--- | | Grant Revenue | $5.8 million | $4.9 million | | Operating Loss | $14.7 million | $13.3 million | | Net Loss | $13.0 million | $13.3 million | | Net Loss Per Share (basic) | $(1.95) | $(4.24) | | Cash and Investments (at Dec 31) | $3.6 million | $8.6 million | [Company Overview](index=3&type=section&id=About%20Plus%20Therapeutics) Plus Therapeutics, Inc. is a Houston-based clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for difficult-to-treat central nervous system (CNS) cancers, with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). Its wholly owned subsidiary, CNSide Diagnostics, LLC, is developing and commercializing laboratory tests like CNSide™ to detect and characterize tumor cells in the cerebrospinal fluid, with a planned U.S. launch in 2025 - Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for CNS cancers, combining image-guided local beta radiation with targeted drug delivery[11](index=11&type=chunk) - CNSide Diagnostics, a wholly owned subsidiary, develops and commercializes proprietary tests to identify tumor cells that have metastasized to the CNS. Its CNSide™ platform is planned for commercialization in the U.S. in **2025**[12](index=12&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the company's consolidated financial statements, including balance sheets, statements of operations, and statements of cash flows [Consolidated Balance Sheets](index=5&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) The consolidated balance sheets present the company's financial position, including assets, liabilities, and stockholders' equity, as of December 31, 2024 and 2023 Consolidated Balance Sheets (in thousands) | As of December 31, | 2024 | 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $ 76 | $ 8,554 | | Investments | $ 3,530 | $ — | | Total current assets | $ 5,259 | $ 9,834 | | Total assets | $ 6,633 | $ 11,388 | | **Liabilities and Stockholders' Equity (Deficit)** | | | | Total current liabilities | $ 15,551 | $ 10,727 | | Total liabilities | $ 15,582 | $ 12,736 | | Total stockholders' equity (deficit) | $ (8,949) | $ (1,348) | | Total liabilities and stockholders' equity (deficit) | $ 6,633 | $ 11,388 | [Consolidated Statements of Operations](index=6&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The consolidated statements of operations detail the company's revenues, expenses, and net loss for the years ended December 31, 2024 and 2023 Consolidated Statements of Operations (in thousands, except per share data) | For the Years Ended December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Grant revenue | $ 5,824 | $ 4,913 | | Research and development | $ 10,580 | $ 9,690 | | General and administrative | $ 9,939 | $ 8,544 | | Total operating expenses | $ 20,519 | $ 18,234 | | Operating loss | $ (14,695) | $ (13,321) | | Net loss | $ (12,978) | $ (13,316) | | Net loss per share of common stock - basic | $ (1.95) | $ (4.24) | | Weighted average number of shares outstanding - basic | 6,640,251 | 3,140,925 | [Consolidated Statements of Cash Flows](index=7&type=section&id=CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) The consolidated statements of cash flows summarize the company's cash inflows and outflows from operating, investing, and financing activities for 2024 and 2023 Consolidated Statements of Cash Flows (in thousands) | For the Years Ended December 31, | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $ (10,554) | $ (12,851) | | Net cash used in investing activities | $ (4,111) | $ (160) | | Net cash provided by financing activities | $ 6,187 | $ 3,445 | | Net decrease in cash and cash equivalents | $ (8,478) | $ (9,566) | | Cash and cash equivalents at end of period | $ 76 | $ 8,554 |

The recent $15 million financing accelerates development of REYOBIQ™ and launch of CNSide™HOUSTON, March 27, 2025 (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 announces financial results for the fourth quarter and full year ended December 31, 2024, and provides an overview of recent and upcoming business highlights. “ ...

Core Viewpoint - Plus Therapeutics, Inc. (PSTV) experienced a significant share price increase of 170.1% following the FDA's conditional acceptance of the proprietary name "Reyobiq" for its lead therapeutic candidate, rhenium Re186 obisbemeda [1] Company Developments - The company will now use the proprietary name Reyobiq for all communications related to the previously adopted generic name rhenium Re186 obisbemeda [2] - Reyobiq is being developed as a novel injectable radiotherapy aimed at delivering targeted high-dose radiation for central nervous system tumors, potentially improving patient outcomes [2] - Plus Therapeutics is focusing on Reyobiq for treating leptomeningeal metastases (LM) and recurrent glioblastoma (GBM) [4] - The FDA granted Orphan Drug Designation to Reyobiq for treating LM in lung cancer patients, a rare complication where cancer spreads to the cerebrospinal fluid [4] - Enrollment for the ReSPECT-LM phase I study has been completed, which will assess the safety and efficacy of Reyobiq in patients with LM [5] - The company is preparing for a phase II single-dose expansion study and a phase I multiple-dose study for Reyobiq in LM patients [5] - Reyobiq is also being evaluated in the phase I/II ReSPECT-GBM study for recurrent glioblastoma treatment [6] Market Performance - Over the past year, shares of Plus Therapeutics have declined by 26.2%, while the industry average has decreased by 6.7% [3]

深夜暴涨。 拼多多董事长兼联席CEO陈磊在财报中表示："2024年，公司致力于推动平台生态系统和更广泛供应链的可持续发展。通过对平台运营和行业支持政策的针对 性创新，公司将继续推动高质量发展战略，从而使更广泛的电子商务生态系统受益。"陈磊称，过去几个季度拼多多在生态建设上投入，帮助平台更好应对消 费变化、产业转型以及行业竞争。 当地时间3月20日（周四），美股三大指数集体小幅收跌，截至收盘，道琼斯指数微跌0.03%，标普500指数下跌0.22%，纳斯达克指数下跌0.33%。热门科技 股多数下跌，苹果、亚马逊、谷歌A、微软跌幅均在1%以内，而特斯拉、英伟达和Meta微涨。 中概股集体大跌，纳斯达克中国金龙指数跌下3.84%，创下了2月25日以来最大的单日跌幅。 此外，制药公司PlusTherapeutics大涨170.06%，换手率达5897.62%，盘中涨幅一度超过300%，多次熔断。PlusTherapeutics此前曾宣布，其针对肺癌患者软脑 膜转移的治疗药物Rhenium(186Re) Obisbemeda获得美国食品药品监督管理局（FDA）"孤儿药"资格认定。 | us Plus Therapeuti ...