Plus Therapeutics, Inc. (PSTV) Q1 2023 Earnings Conference Call April 20, 2023 5:00 PM ET Corporate Participants Marc Hedrick - President and Chief Executive Officer Norman LaFrance - Chief Medical Officer Andrew Sims - Chief Financial Officer Conference Call Participants Justin Walsh - Jones Trading Sean Lee - HC Wainwright Edward Woo - Ascendiant Capital Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics First Quarter 2023 Results Conference Call. Before we begin, we want to a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-34375 PLUS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) DELAWARE 33-0827593 (State or other jurisdi ...

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2022 Earnings Conference Call February 23, 2023 5:00 PM ET Company Participants Marc Hedrick - President and Chief Executive Officer Norman LaFrance - Chief Medical Officer Andrew Sims - Chief Financial Officer Conference Call Participants Justin Walsh - Jones Trading Edward Woo - Ascendiant Capital Sean Lee - HC Wainwright Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full Year 2022 Results Conference Call. Before ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-34375 PLUS THERAPEUTICS, INC. (Exact name of Registrant as Specified in Its Charter) DELAWARE 33-0827593 (State or Other Jurisdiction ...

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2022 Earnings Conference Call October 20, 2022 5:00 PM ET Corporate Participants Marc Hedrick - President and Chief Executive Officer Norman LaFrance - Chief Medical Officer Andrew Sims - Chief Financial Officer Conference Call Participants Justin Walsh - Jones Trading Edward Woo - Ascendiant Sean Lee - HC Wainwright Brandon Carney - B. Riley Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Third Quarter 2022 Results Call. Before we beg ...

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q%20Filing%20Information) This section details the filing specifics of the Quarterly Report (Form 10-Q) for PLUS THERAPEUTICS, INC., including key company identification and stock information - The document is a Quarterly Report (Form 10-Q) for the period ended September 30, 2022, filed by PLUS THERAPEUTICS, INC[1](index=1&type=chunk)[2](index=2&type=chunk) Registrant Information | Registrant Name | PLUS THERAPEUTICS, INC. | | :--- | :--- | | State of Incorporation | DELAWARE | | Principal Executive Offices | 4200 MARATHON BLVD., SUITE 200, AUSTIN, TX 78756 | | Telephone Number | (737) 255-7194 | | Trading Symbol | PSTV | | Exchange | Nasdaq Capital Market | | Filer Status | Non-Accelerated Filer, Smaller reporting company | | Common Stock Outstanding (Oct 14, 2022) | 33,601,373 shares | [Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns that the report contains forward-looking statements based on management's expectations, which are subject to material risks and uncertainties - This report contains forward-looking statements, identified by terms like 'intend,' 'expect,' 'project,' 'believe,' 'anticipate,' and similar expressions, which are based on management's assumptions and perceptions of historical trends, current conditions, and future developments[8](index=8&type=chunk) - These statements cover anticipated expenditures (R&D, G&A), strategic collaborations, intellectual property, FDA approvals, market size, clinical study results, product candidate efficacy/safety, anticipated progress in trials, IP strategy, CPRIT Grant compliance, competition, revenue generation, regulatory approvals, future performance, liquidity, going concern status, Nasdaq listing, debt repayment, manufacturing transfer, and cash position enhancement[9](index=9&type=chunk) - Actual results may differ materially due to various factors, including the early stage of product candidates, R&D uncertainties, liquidity and capital resources, partnering efforts, regulatory requirements, market conditions, litigation, and competition, as detailed in the 'Risk Factors' sections of this report and the Annual Report on Form 10-K[9](index=9&type=chunk)[10](index=10&type=chunk)[11](index=11&type=chunk) [Part I. Financial Information](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements for Plus Therapeutics, Inc., including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with accompanying notes, providing a snapshot of the company's financial position and performance for the periods ended September 30, 2022 and 2021 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity as of September 30, 2022, and December 31, 2021 Condensed Balance Sheet Highlights (in thousands) | Metric | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,266 | $18,400 | | Total current assets | $20,879 | $19,724 | | Total assets | $23,104 | $21,981 | | Total current liabilities | $7,420 | $5,870 | | Total liabilities | $11,700 | $11,145 | | Total stockholders' equity | $11,404 | $10,836 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) This section presents the company's revenues, expenses, and net loss for the three and nine months ended September 30, 2022, and 2021 Condensed Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Grant revenue | $73 | $— | $73 | $— | | Research and development | $2,945 | $1,491 | $7,560 | $3,724 | | General and administrative | $2,222 | $1,990 | $6,653 | $4,811 | | Total operating expenses | $5,167 | $3,499 | $14,213 | $8,553 | | Operating loss | $(5,094) | $(3,499) | $(14,140) | $(8,553) | | Net loss | $(5,219) | $(3,724) | $(14,617) | $(9,244) | | Net loss per share, basic and diluted | $(0.19) | $(0.28) | $(0.61) | $(0.84) | [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) This section details the changes in the company's stockholders' equity, including common stock and accumulated deficit, for the nine months ended September 30, 2022 Changes in Stockholders' Equity (in thousands) | Metric | Balance at Dec 31, 2021 | Balance at Sep 30, 2022 | | :--- | :--- | :--- | | Common stock shares | 15,510,025 | 32,570,002 | | Common stock amount | $16 | $32 | | Additional paid-in capital | $457,730 | $472,899 | | Accumulated deficit | $(446,910) | $(461,527) | | Total stockholders' equity | $10,836 | $11,404 | - During the nine months ended September 30, 2022, the company issued **17,059,977 shares of common stock**, primarily through sales of common stock, net, which contributed to an increase in additional paid-in capital[19](index=19&type=chunk) - The accumulated deficit increased by **$14,617 thousand** during the nine months ended September 30, 2022, reflecting the net loss for the period[17](index=17&type=chunk)[19](index=19&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section outlines the company's cash inflows and outflows from operating, investing, and financing activities for the nine months ended September 30, 2022, and 2021 Condensed Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,738) | $(7,656) | | Net cash used in investing activities | $(748) | $(84) | | Net cash provided by financing activities | $13,352 | $20,674 | | Net increase in cash and cash equivalents | $1,866 | $12,934 | | Cash and cash equivalents at end of period | $20,266 | $21,280 | - The increase in cash used in operating activities for the nine months ended September 30, 2022, was primarily due to higher research and development expenditures[138](index=138&type=chunk)[140](index=140&type=chunk)[164](index=164&type=chunk) - Financing activities in 2022 were mainly driven by **$14.6 million** in proceeds from common stock sales, while 2021 also included **$2.0 million** from warrant exercises[21](index=21&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides additional information and explanations for the condensed financial statements, including accounting policies, significant estimates, and details on grants, debt, and legal proceedings - The unaudited condensed financial statements are prepared in accordance with GAAP for interim information and should be read with the 2021 Annual Report on Form 10-K. Grant revenue is recognized when related costs are incurred, applying ASC 606 by analogy, as government grants are outside the scope of ASC 606[23](index=23&type=chunk)[24](index=24&type=chunk)[55](index=55&type=chunk) - The company incurred net losses of **$14.6 million** and used **$10.7 million** in cash from operations for the nine months ended September 30, 2022, resulting in an accumulated deficit of **$461.5 million**. Current cash and cash equivalents are expected to fund operations for at least the next 12 months[32](index=32&type=chunk)[33](index=33&type=chunk) - On September 19, 2022, the company entered into a Cancer Research Grant Contract (CPRIT Contract) for up to **$17.6 million** to fund 186RNL development for leptomeningeal metastases (LM), subject to matching funds, revenue sharing, and reporting requirements[29](index=29&type=chunk)[52](index=52&type=chunk) - The company has a Term Loan with Oxford Finance, LLC, with **$2.8 million** principal outstanding as of September 30, 2022 (excluding a **$3.2 million** final payment fee), collateralized by substantially all assets, and was in compliance with all debt covenants[43](index=43&type=chunk)[47](index=47&type=chunk) - The company has various financing agreements, including a 2022 Purchase Agreement with Lincoln Park for up to **$50.0 million** in common stock sales and a September 2022 Distribution Agreement with Canaccord Genuity LLC for up to **$5.0 million** in at-the-market common stock sales[78](index=78&type=chunk)[89](index=89&type=chunk) - The company is a defendant in a legal proceeding brought by Lorem Vascular, Pte. Ltd. alleging false representations regarding a UK manufacturing facility, with Lorem claiming at least **$6 million** in damages. The company believes the claim is without merit[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, highlighting key business developments, clinical trial progress, recent financing activities, and a detailed breakdown of revenues and expenses for the three and nine months ended September 30, 2022 and 2021 [Overview](index=18&type=section&id=Overview) This section introduces Plus Therapeutics, Inc. as a pharmaceutical company developing targeted radiotherapeutics for rare cancers, outlining its core technology and lead product candidates - Plus Therapeutics, Inc. is a U.S. pharmaceutical company focused on developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers in adults and children[101](index=101&type=chunk) - The company's technology involves encapsulating radionuclides (e.g., Rhenium isotopes) within nanoliposomes and microspheres to deliver high, targeted radiation doses to tumors, aiming to minimize exposure to healthy tissues and improve safety margins[101](index=101&type=chunk)[103](index=103&type=chunk) - Lead candidates include Rhenium-186 NanoLiposome (186RNL) for CNS cancers (glioblastoma, leptomeningeal metastases, pediatric brain cancers) and Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM) for solid organ cancers[104](index=104&type=chunk) [Pipeline](index=18&type=section&id=Pipeline) This section details the company's lead investigational drug, 186RNL, and other pipeline candidates, including their clinical trial progress and development status - The lead investigational drug, 186RNL, is a patented radiotherapy for CNS and other cancers, with preclinical data published and an active **$3.0 million** NIH/NCI award supporting its Phase 2 clinical trial for recurrent glioblastoma (GBM)[106](index=106&type=chunk)[107](index=107&type=chunk) - Current clinical trials include ReSPECT-GBM and ReSPECT-LM (leptomeningeal metastases), with an IND application for ReSPECT-PBC (pediatric brain cancer) anticipated in late 2022 or early 2023[109](index=109&type=chunk) - FDA has agreed with the company's proposed cGMP guidance for 186RNL manufacturing, which is expected to apply across all 186RNL clinical development programs[110](index=110&type=chunk)[111](index=111&type=chunk) - Updated data from the ReSPECT-GBM trial showed no dose-limiting toxicities, a strong safety profile, and improved median overall survival (**22.9 months**) in patients receiving a therapeutic absorbed radiation dose (**>100 Gray**) compared to subtherapeutic doses (**5.6 months**)[119](index=119&type=chunk) - The ReSPECT-LM Phase 1 clinical trial's first cohort was well-tolerated with no significant adverse events, demonstrating 186RNL distribution in CSF and decreased CSF cell count. The trial's continued development through Phase 2 is funded by a **$17.6 million** CPRIT grant[122](index=122&type=chunk)[123](index=123&type=chunk) - The company licensed Biodegradable Alginate Microsphere (BAM) technology in January 2022 to combine with Rhenium NanoLiposome technology, creating 188RNL-BAM for intra-arterial embolization and targeted radiation delivery for solid organ cancers, with preclinical development ongoing[129](index=129&type=chunk)[130](index=130&type=chunk) [Recent Developments](index=22&type=section&id=Recent%20Developments) This section highlights key corporate and clinical milestones, including new grant funding, strategic agreements, and licensing activities - On September 19, 2022, the company secured a Cancer Research Grant Contract (CPRIT Contract) for up to **$17.6 million** to fund the continued development of 186RNL for leptomeningeal metastases (LM) over three years, with matching fund and revenue sharing obligations[131](index=131&type=chunk) - A multi-year laboratory services agreement was announced with Biocept, Inc. on June 22, 2022, to utilize their CNSide cerebrospinal fluid (CSF) assay in the ReSPECT-LM Phase 1/2a dose-escalation trial[132](index=132&type=chunk) - On March 31, 2022, a Sales Order was executed with Medidata Solutions, Inc. for the development of a Synthetic Control Arm® (SCA) platform to integrate historical clinical data into the company's Phase 2 clinical trial of 186RNL in glioblastoma (GBM)[133](index=133&type=chunk) - An exclusive license agreement was entered into with UT Health Science Center at San Antonio on December 31, 2021, for global rights to develop and commercialize 188RNL-BAM, requiring commercial reasonable efforts and future milestone/earn-out payments[135](index=135&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the company's financial performance, breaking down grant revenue, operating expenses, and financing items for the reported periods [Grant Revenue](index=22&type=section&id=Grant%20Revenue) This section details the grant revenue recognized by the company, primarily from the CPRIT Contract, for the reported periods - The company recognized **$73,000** in grant revenue for both the three and nine months ended September 30, 2022, stemming from the CPRIT Contract for 186RNL development for LM[137](index=137&type=chunk) [Research and development expenses](index=22&type=section&id=Research%20and%20development%20expenses) This section analyzes the changes in research and development expenditures, highlighting key drivers such as drug development and clinical trial costs Research and Development Expenses (in thousands) | Period | 2022 | 2021 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $2,945 | $1,491 | +$1,454 (+97.5%) | | Nine Months Ended Sep 30 | $7,560 | $3,724 | +$3,836 (+103.0%) | - The increase in R&D expenses for the three months ended September 30, 2022, was primarily due to a **$0.4 million** increase in cGMP 186RNL drug development, an **$0.8 million** increase in other expenses (including SCA development), and a **$0.3 million** increase in personnel and travel-related expenses[139](index=139&type=chunk) - For the nine months ended September 30, 2022, the increase was mainly driven by a **$1.8 million** rise in cGMP 186RNL drug development and a **$2.2 million** increase in other expenses, including SCA development[140](index=140&type=chunk) - Aggregate R&D expenditures are expected to increase in absolute dollars for the remainder of 2022 due to ongoing development of 186RNL and 188RNL-BAM therapies[141](index=141&type=chunk) [General and administrative expenses](index=23&type=section&id=General%20and%20administrative%20expenses) This section examines the trends in general and administrative expenses, focusing on professional fees and personnel-related costs General and Administrative Expenses (in thousands) | Period | 2022 | 2021 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $2,222 | $1,990 | +$232 (+11.7%) | | Nine Months Ended Sep 30 | $6,653 | $4,811 | +$1,842 (+38.3%) | - The increase in G&A expenses for the three months ended September 30, 2022, was primarily due to a **$0.2 million** increase in litigation, legal fees, and other professional expenses[142](index=142&type=chunk) - For the nine months ended September 30, 2022, the increase was mainly attributable to a **$1.6 million** rise in litigation, legal fees, intellectual property, and other professional expenses, along with a **$0.2 million** increase in personnel-related expenses[142](index=142&type=chunk) - G&A expenditures are expected to remain generally consistent in 2022 compared to 2021, though subject to unpredictable additional litigation costs[143](index=143&type=chunk) [Stock-based compensation expense](index=23&type=section&id=Stock-based%20compensation%20expense) This section explains the fluctuations in stock-based compensation expenses, attributing them to changes in option grants and vesting schedules Stock-based Compensation Expenses (in thousands) | Period | 2022 | 2021 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended Sep 30 | $129 | $180 | -$51 (-28.3%) | | Nine Months Ended Sep 30 | $476 | $425 | +$51 (+12.0%) | - Fluctuations in stock-based compensation are attributed to changes in the grants of stock-based options, their vesting schedules, and the grant-date fair value of these awards[144](index=144&type=chunk) [Financing items](index=24&type=section&id=Financing%20items) This section details the company's interest income, interest expense, and changes in fair value of liability instruments, and their impact on financial results Financing Items (in thousands) | Item | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Interest income | $48 | $5 | $74 | $13 | | Interest expense | $(173) | $(232) | $(552) | $(708) | | Change in fair value of liability instruments | $0 | $2 | $1 | $4 | | Total | $(125) | $(225) | $(477) | $(691) | - The decrease in interest expense for both the three and nine months ended September 30, 2022, was primarily due to principal repayments of **$0.4 million** and **$1.2 million**, respectively, compared to no principal payments in the same periods of 2021[146](index=146&type=chunk) - Interest expense is expected to decrease in 2022 compared to 2021 due to scheduled debt principal repayments that commenced on November 1, 2021[147](index=147&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term obligations, reviewing cash position, working capital, and financing activities Key Liquidity Measures (in thousands) | Metric | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $20,266 | $18,400 | | Current assets | $20,879 | $19,724 | | Current liabilities | $7,420 | $5,870 | | Working capital | $13,459 | $13,854 | - The company's cash and cash equivalents of **$20.3 million** at September 30, 2022, are believed to be sufficient to fund operations for at least the next twelve months[148](index=148&type=chunk) - Net cash used in operating activities increased to **$10.7 million** for the nine months ended September 30, 2022, from **$7.7 million** in the prior year, primarily due to increased research and development expenditures[160](index=160&type=chunk)[164](index=164&type=chunk) - Financing activities provided **$13.352 million** in cash for the nine months ended September 30, 2022, mainly from common stock sales, compared to **$20.674 million** in the prior year[160](index=160&type=chunk)[166](index=166&type=chunk) - The company continues to seek additional capital through strategic transactions and financing alternatives, as current working capital and grant funds may be insufficient for ongoing research and product development activities at current levels[149](index=149&type=chunk)[159](index=159&type=chunk) - Material cash obligations include matching funds for the CPRIT Contract, payments for the Medidata Sales Order, and approximately **$6.0 million** in remaining principal and interest payments under the Term Loan with Oxford through June 1, 2024[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Critical Accounting Policies and Significant Estimates](index=26&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Estimates) This section outlines the key accounting policies and management estimates that significantly impact the company's financial statements - The preparation of financial statements requires management to make estimates and assumptions, particularly concerning grant revenue recognition, asset impairment, and stock-based compensation expense[28](index=28&type=chunk)[168](index=168&type=chunk) - Goodwill is reviewed for impairment annually during the fourth quarter, or more frequently if impairment indicators exist, given the company operates in a single reporting unit and has experienced stock price volatility[170](index=170&type=chunk) - Liability-classified warrants are fair valued using an option pricing model, with changes in fair value recorded as non-operating income or loss in the statements of operations[171](index=171&type=chunk) - There have been no material changes to the critical accounting policies and estimates discussed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2021[172](index=172&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section states that there are no applicable quantitative and qualitative disclosures about market risk for the company - Not applicable[173](index=173&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of September 30, 2022, concluding they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - The company's disclosure controls and procedures were evaluated by management, including the CEO and CFO, and concluded to be effective at the reasonable assurance level as of September 30, 2022[174](index=174&type=chunk)[175](index=175&type=chunk) - There have been no material changes in the company's internal control over financial reporting during the quarter ended September 30, 2022[176](index=176&type=chunk) [Part II. Other Information](index=27&type=section&id=PART%20II%20OTHER%20INFORMATION) This part includes disclosures on legal proceedings, risk factors, unregistered sales of equity securities, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is a defendant in a lawsuit filed by Lorem Vascular, Pte. Ltd. on June 22, 2021, alleging false representations regarding the sale of a UK manufacturing facility. Lorem claims at least $6 million in damages, but the company believes the claim is without merit and is vigorously defending the case - The company is a defendant in a lawsuit initiated by Lorem Vascular, Pte. Ltd. on June 22, 2021, in the District Court for the District of Delaware[177](index=177&type=chunk) - The complaint alleges false representations were made concerning the UK manufacturing facility purchased by Lorem from the company and its certification to sell and distribute devices in the European Union and export to China[177](index=177&type=chunk) - Lorem claims entitlement to at least **$6,000,000** in compensatory damages and operational costs. The company believes the claim is without merit and is vigorously defending the case[177](index=177&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section outlines additional and updated risk factors, primarily focusing on potential substantial dilution from future equity issuances (including sales to Lincoln Park and Canaccord) and the requirements and potential penalties associated with government funding, specifically the CPRIT Grant. It also highlights the risk of delisting from Nasdaq due to non-compliance with the minimum bid price requirement - Stockholders may experience substantial dilution from future issuances of common stock or other convertible securities, potentially at prices lower than existing stockholders paid, which could grant new investors superior rights[179](index=179&type=chunk)[180](index=180&type=chunk) - The 2022 Purchase Agreement with Lincoln Park allows for the sale of up to **$50.0 million** of common stock, and the September 2022 Distribution Agreement with Canaccord permits sales of up to **$5.0 million** via 'at the market' offerings, both of which could cause the stock price to fall and make future equity financing more difficult[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk) - Reliance on the CPRIT Grant imposes significant requirements, including maintaining headquarters in Texas and potential repayment obligations (up to **400%** of grant proceeds in revenue sharing, or full repayment with interest under certain termination conditions or relocation outside Texas)[185](index=185&type=chunk)[186](index=186&type=chunk)[187](index=187&type=chunk) - The company received a Nasdaq notice on May 24, 2022, for non-compliance with the **$1.00** minimum bid price requirement, with an initial compliance period until November 21, 2022. Failure to regain compliance could lead to delisting, severely harming stock liquidity and ability to raise capital[188](index=188&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company's Board of Directors approved a share repurchase program on August 15, 2022, authorizing repurchases of up to $2.0 million of common stock over 12 months, subject to market conditions and lender consent. As of the filing date, no shares have been repurchased under this program - On August 15, 2022, the Board of Directors approved a share repurchase program authorizing the company to repurchase up to **$2.0 million** of its outstanding common stock[191](index=191&type=chunk) - The timing and amount of repurchases will be determined based on market conditions and other factors, including the consent of Oxford, the company's lender[191](index=191&type=chunk) - The program allows for repurchases over 12 months, but the company is not obligated to acquire any shares, and the program may be discontinued or suspended at any time. No shares have been repurchased as of the Form 10-Q filing date[191](index=191&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, stock incentive plans, purchase and distribution agreements, grant contracts, and certifications - Exhibits include corporate governance documents (Certificate of Incorporation, Bylaws), the 2020 Stock Incentive Plan, and various agreements[194](index=194&type=chunk) - Key agreements filed are the Purchase Agreement and Registration Rights Agreement with Lincoln Park Capital Fund, LLC (August 2, 2022), the Distribution Agreement with Canaccord Genuity LLC (September 9, 2022), and the Cancer Research Grant Contract with CPRIT (effective August 31, 2022)[194](index=194&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial and Accounting Officer, as required by the Sarbanes-Oxley Act of 2002, are also included[194](index=194&type=chunk)[195](index=195&type=chunk) [Signatures](index=33&type=section&id=SIGNATURES) This section confirms the official signing and filing of the report by the company's principal executive and financial officers - The report was duly signed on behalf of PLUS THERAPEUTICS, INC. on October 20, 2022[198](index=198&type=chunk)[200](index=200&type=chunk) - Signatories include Marc H. Hedrick, President & Chief Executive Officer (Principal Executive Officer), and Andrew Sims, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)[199](index=199&type=chunk)[200](index=200&type=chunk)

The ReSPECT-GBM Phase 1/2a Trial of Rhenium-186 NanoLiposome ( 186RNL) in Recurrent Glioma via Convection-Enhanced Delivery (CED) Abstract 277O Andrew J. Brenner1, Ande Bao1, William Phillips1, Joel E. Michalek1, Marc H Hedrick2, Norman LaFrance2, Toral R. Patel3, Jeffrey S. Weinberg4, John Floyd1 1Mays Cancer Center at UT Health San Antonio, Texas, USA 9 September 2022; 2Plus Therapeutics, Austin, TX USA; 3UT Southwestern, Dallas Texas, USA; 4MD Anderson Cancer Center, Houston, TX, USA | --- | --- | --- | ...

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q2 2022 Results Conference Call July 21, 2022 5:00 PM ET Company Participants Dr. Marc Hedrick - President and Chief Executive Officer Dr. Norman LaFrance - Chief Medical Officer Andrew Sims - Chief Financial Officer Conference Call Participants Michael Rabinowitz - Maxim Group Ed Woo - Ascendiant Capital Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Second Quarter 2022 Results Call. Before we begin, we want to advise you that over the ...

[Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines the nature and inherent risks of forward-looking statements, identifying key areas covered and referencing relevant risk factor disclosures - Forward-looking statements are identified by terms such as "intend," "expect," "project," "believe," "anticipate," and similar expressions, or their negatives[8](index=8&type=chunk) - These statements are subject to material risks and uncertainties, including those detailed in "Part I – Item 1A – Risk Factors" of the Annual Report on Form 10-K for 2021 and "Part II – Item 1A – Risk Factors" in this Quarterly Report[9](index=9&type=chunk)[10](index=10&type=chunk) - Key areas covered by forward-looking statements include anticipated expenditures, strategic collaborations, FDA approvals, market size, R&D efforts, clinical trial results, product candidate efficacy/safety, competition, and liquidity/capital resources[9](index=9&type=chunk) [PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the Company's unaudited condensed financial statements, management's discussion and analysis, market risk disclosures, and controls and procedures for the reporting period [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section provides the unaudited condensed financial statements, including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the basis of presentation, significant accounting policies, and specific financial line items [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) This section presents a snapshot of the Company's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates **Condensed Balance Sheet Highlights (in thousands)** | Metric | June 30, 2022 | December 31, 2021 | | :-------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $18,090 | $18,400 | | Total current assets | $18,889 | $19,724 | | Total assets | $21,271 | $21,981 | | Total current liabilities | $6,971 | $5,870 | | Total liabilities | $11,592 | $11,145 | | Total stockholders' equity | $9,679 | $10,836 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) This section details the Company's financial performance over specific periods, highlighting revenues, expenses, and net loss **Condensed Statements of Operations Highlights (in thousands, except per share data)** | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $2,831 | $1,106 | $4,615 | $2,233 | | General and administrative | $2,289 | $1,469 | $4,431 | $2,821 | | Total operating expenses | $5,120 | $2,575 | $9,046 | $5,054 | | Operating loss | $(5,120) | $(2,575) | $(9,046) | $(5,054) | | Net loss | $(5,282) | $(2,800) | $(9,398) | $(5,520) | | Net loss per share, basic and diluted | $(0.24) | $(0.25) | $(0.43) | $(0.56) | - Research and development expenses increased significantly by **$1.7 million (154.6%)** for the three months ended June 30, 2022, and by **$2.4 million (107.5%)** for the six months ended June 30, 2022, compared to the same periods in 2021[16](index=16&type=chunk) - General and administrative expenses increased by **$0.8 million (54.5%)** for the three months ended June 30, 2022, and by **$1.6 million (56.4%)** for the six months ended June 30, 2022, compared to the same periods in 2021[16](index=16&type=chunk) [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) This section tracks changes in the Company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit **Condensed Statements of Stockholders' Equity Highlights (in thousands, except share data)** | Metric | Balance at Dec 31, 2021 | Balance at Jun 30, 2022 | | :-------------------------- | :---------------------- | :---------------------- | | Common stock shares | 15,510,025 | 22,468,682 | | Common stock amount | $16 | $22 | | Additional paid-in capital | $457,730 | $465,965 | | Accumulated deficit | $(446,910) | $(456,308) | | Total stockholders' equity | $10,836 | $9,679 | - The company issued **6,687,610 shares** of common stock for net proceeds of **$7,742 thousand** during the six months ended March 31, 2022, and an additional **271,047 shares** for **$152 thousand** during the three months ended June 30, 2022[18](index=18&type=chunk) - Stock-based compensation expense contributed **$347 thousand** to additional paid-in capital for the six months ended June 30, 2022[18](index=18&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section reports the cash inflows and outflows from operating, investing, and financing activities over specific periods **Condensed Statements of Cash Flows Highlights (in thousands)** | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(6,516) | $(5,405) | | Net cash used in investing activities | $(715) | $(80) | | Net cash provided by financing activities | $6,921 | $14,300 | | Net increase (decrease) in cash | $(310) | $8,815 | | Cash and cash equivalents at end of period | $18,090 | $17,161 | - The decrease in net cash provided by financing activities was primarily due to lower proceeds from the sale of common stock (**$7.7 million** in 2022 vs. **$12.3 million** in 2021) and no proceeds from warrant exercises in 2022 compared to **$2.0 million** in 2021[20](index=20&type=chunk) - Investing activities saw a significant increase in cash used, primarily due to purchases of intangible assets (**$117k**) and in-process R&D acquired (**$250k**) in 2022, which were not present in 2021[20](index=20&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed financial statements, including accounting policies, estimates, and specific financial line items [1. Basis of Presentation and New Accounting Standards](index=8&type=section&id=1.%20Basis%20of%20Presentation%20and%20New%20Accounting%20Standards) This note describes the basis for preparing the interim financial statements and the expected impact of new accounting standards - The unaudited condensed financial statements are prepared in accordance with U.S. GAAP for interim financial information and do not include all annual financial statement disclosures[23](index=23&type=chunk) - The Company plans to adopt ASU 2016-13 (Credit Losses) on January 1, 2023, and does not expect a material impact on its financial statements[24](index=24&type=chunk) [2. Use of Estimates](index=8&type=section&id=2.%20Use%20of%20Estimates) This note explains management's reliance on estimates and assumptions in financial reporting and the potential for actual results to differ - Financial statement preparation requires management to make estimates and assumptions, particularly for asset impairment and stock-based compensation expense[25](index=25&type=chunk) - Actual results may differ from these estimates, and revisions are reflected prospectively[26](index=26&type=chunk) [3. Liquidity](index=8&type=section&id=3.%20Liquidity) This note assesses the Company's ability to meet its short-term and long-term financial obligations, including cash resources and potential capital needs **Liquidity Metrics (in thousands)** | Metric | June 30, 2022 | December 31, 2021 | | :-------------------------- | :-------------- | :---------------- | | Net loss (six months) | $(9,398) | $(5,520) | | Accumulated deficit | $(456,308) | $(446,910) | | Net cash used in operating activities (six months) | $(6,516) | $(5,405) | | Cash and cash equivalents | $18,090 | $18,400 | - The Company believes its current cash and cash equivalents are sufficient to fund operations for at least the next **12 months**[28](index=28&type=chunk) - The Company received a Nasdaq notice on May 24, 2022, for non-compliance with the minimum bid price requirement (**$1.00 per share**) and has until November 21, 2022, to regain compliance[30](index=30&type=chunk)[31](index=31&type=chunk) - Failure to raise additional capital could necessitate significant reductions in R&D and other operations, negatively impacting growth goals[29](index=29&type=chunk) [4. Fair Value Measurements](index=9&type=section&id=4.%20Fair%20Value%20Measurements) This note details the methodology and hierarchy used for measuring the fair value of financial instruments, particularly liability-classified warrants - Fair value measurements are categorized into a three-level hierarchy based on input observability (Level 1: active market quotes, Level 2: similar active market quotes or observable inputs, Level 3: unobservable inputs)[34](index=34&type=chunk) - Series U Warrants are classified as **Level 3 liability instruments** and are marked to market, with changes in fair value recorded as non-operating income or loss[34](index=34&type=chunk)[35](index=35&type=chunk) - The fair value of Series U Warrants and the change in fair value were immaterial for the three and six months ended June 30, 2022 and 2021[35](index=35&type=chunk) [5. Term Loan Obligations](index=9&type=section&id=5.%20Term%20Loan%20Obligations) This note outlines the Company's term loan agreement, including principal amount, interest rates, repayment terms, and compliance with covenants - The Company has a Term Loan with Oxford Finance, LLC, with an aggregate principal amount of **$17.7 million**, accruing interest at a floating rate of at least **8.95% per annum**[36](index=36&type=chunk) - Principal and interest payments are required monthly through the maturity date of June 1, 2024, with a final payment of approximately **$3.2 million**[36](index=36&type=chunk) - As of June 30, 2022, **$3.1 million** principal was outstanding, and the Company was in compliance with all debt covenants[40](index=40&type=chunk) **Interest Expense (in thousands)** | Period | 2022 | 2021 | | :-------------------------- | :--- | :--- | | Three Months Ended June 30, | $181 | $229 | | Six Months Ended June 30, | $379 | $476 | [6. Loss per Share](index=10&type=section&id=6.%20Loss%20per%20Share) This note explains the calculation of basic and diluted loss per share, identifying anti-dilutive securities excluded from the diluted calculation - Basic and diluted loss per share are calculated by dividing net loss by the weighted average number of common shares outstanding[43](index=43&type=chunk) - Potential common shares from outstanding stock options, preferred stock, and warrants were excluded from diluted loss per share calculations as their effect would be anti-dilutive[44](index=44&type=chunk) **Anti-Dilutive Securities (as of June 30)** | Security Type | 2022 | 2021 | | :-------------------- | :--------- | :--------- | | Outstanding stock options | 1,183,873 | 1,090,890 | | Preferred stock | 422,867 | 422,867 | | Outstanding warrants | 2,141,189 | 2,141,378 | | **Total** | **3,747,929** | **3,655,135** | [7. Commitments and Contingencies](index=10&type=section&id=7.%20Commitments%20and%20Contingencies) This note details the Company's contractual obligations and potential liabilities, including leases, service agreements, and legal proceedings [Leases](index=10&type=section&id=Leases) This section details the Company's operating lease agreements, including lease costs and future minimum annual payments - The Company leases laboratory, office, and storage facilities under operating lease agreements, with the primary San Antonio lease expiring in 2025[48](index=48&type=chunk) **Lease Costs (in thousands)** | Lease Expense | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease expense | $46 | $58 | $92 | $108 | | Finance lease expense | $0 | $3 | $0 | $7 | | **Total lease expense** | **$46** | **$61** | **$92** | **$115** | **Future Minimum Annual Lease Payments (in thousands)** | Year | Operating Leases | | :-------------------- | :--------------- | | Remainder of 2022 | $68 | | 2023 | $137 | | 2024 | $113 | | 2025 | $17 | | **Total minimum lease payments** | **$335** | [Services Agreement and Sales Order with Medidata](index=12&type=section&id=Services%20Agreement%20and%20Sales%20Order%20with%20Medidata) This section describes the agreement with Medidata for developing a Synthetic Control Arm® platform for a Phase 2 clinical trial - On March 31, 2022, the Company entered into a Sales Order with Medidata to build a Synthetic Control Arm® (SCA) platform for its Phase 2 clinical trial of Rhenium-186 NanoLiposome (186RNL) in recurrent glioblastoma (GBM)[54](index=54&type=chunk) - The Sales Order has a six-month term and can be terminated for material breach or if the clinical study is terminated or its authorization withdrawn[55](index=55&type=chunk) [Piramal Master Services Agreement](index=12&type=section&id=Piramal%20Master%20Services%20Agreement) This section outlines the master services agreement with Piramal Pharma Solutions for drug product development and supply - On January 8, 2021, the Company entered into a Master Services Agreement (MSA) with Piramal Pharma Solutions for the development, manufacture, and supply of the Company's RNL-Liposome Intermediate Drug Product[56](index=56&type=chunk) - The MSA has a five-year term with automatic one-year renewals and can be terminated for convenience with thirty days' notice or for material breach/insolvency[57](index=57&type=chunk) [Other commitments and contingencies](index=12&type=section&id=Other%20commitments%20and%20contingencies) This section covers other contractual obligations with research organizations and confirms no clinical research study obligations as of the reporting date - The Company has agreements with research organizations for pre-clinical and clinical development studies, which include cancellation provisions[58](index=58&type=chunk) - As of June 30, 2022, the Company had no clinical research study obligations[58](index=58&type=chunk) [Legal proceedings](index=12&type=section&id=Legal%20proceedings) This section details an ongoing lawsuit against the Company, including allegations, claimed damages, and the Company's defense stance - The Company is a defendant in a lawsuit filed by Lorem Vascular, Pte. Ltd. on June 22, 2021, alleging false representations regarding a UK manufacturing facility and its certifications[59](index=59&type=chunk) - Lorem claims at least **$6.0 million** in compensatory damages and operational costs; the Company believes the claim is without merit and is vigorously defending the case, with no liability accrued as of June 30, 2022[59](index=59&type=chunk) [8. License Agreements](index=13&type=section&id=8.%20License%20Agreements) This note describes the Company's key license agreements for intellectual property related to its therapeutic development programs [UT Health Science Center at San Antonio ("UTHSA") License Agreement](index=13&type=section&id=UT%20Health%20Science%20Center%20at%20San%20Antonio%20(%22UTHSA%22)%20License%20Agreement) This section details the exclusive license agreement with UTHSA for biodegradable alginate microspheres technology - On December 31, 2021, the Company entered into an exclusive, perpetual, fully paid-up license agreement with UTHSA for patents, know-how, and technology related to biodegradable alginate microspheres (BAM)[61](index=61&type=chunk) - An upfront payment of **$250 thousand** was made in January 2022, recorded as in-process research and development acquired[62](index=62&type=chunk) [NanoTx License Agreement](index=13&type=section&id=NanoTx%20License%20Agreement) This section outlines the exclusive license agreement with NanoTx, Corp. for radiolabeled nanoliposomes technology - On March 29, 2020, the Company entered into an exclusive, perpetual, fully paid-up license agreement with NanoTx, Corp. for patents, know-how, and technology related to radiolabeled nanoliposomes[63](index=63&type=chunk) [9. Stockholders' Equity](index=13&type=section&id=9.%20Stockholders%27%20Equity) This note provides details on the Company's preferred stock, warrants, and common stock activities, including recent financing efforts [Preferred Stock](index=13&type=section&id=Preferred%20Stock) This section details the authorized and outstanding shares of preferred stock, including their conversion features - The Company has **5,000,000 authorized shares** of preferred stock (**$0.001 par value**)[64](index=64&type=chunk) - As of June 30, 2022, there were **938 shares** of Series C Preferred Stock (convertible into **416,889 common shares**) and **1,014 shares** of Series B Convertible Preferred Stock (convertible into **5,978 common shares**) outstanding[65](index=65&type=chunk) [Warrants](index=13&type=section&id=Warrants) This section describes the outstanding Series U Warrants, their exercisability, and classification changes - As of June 30, 2022, there were **2,141,000 outstanding Series U Warrants**, exercisable into an aggregate of **2,141,000 shares** of common stock[68](index=68&type=chunk) - Series U Warrants were initially classified as liabilities due to contingent cash settlement obligations but were mostly amended in 2020 to be classified within stockholder's equity[67](index=67&type=chunk) [Common Stock](index=13&type=section&id=Common%20Stock) This section details the Company's common stock activities, including shares issued under purchase and at-the-market agreements [Lincoln Park Purchase Agreement](index=13&type=section&id=Lincoln%20Park%20Purchase%20Agreement) This section describes the agreement with Lincoln Park for common stock purchases and the shares issued under it - Under the 2020 Purchase Agreement, Lincoln Park committed to purchase up to **$25.0 million** of common stock over **36 months**, with the Company having the discretion to sell[69](index=69&type=chunk)[70](index=70&type=chunk) - During the six months ended June 30, 2022, the Company issued **5,665,000 shares** for net proceeds of approximately **$7.0 million**[74](index=74&type=chunk) - The Company no longer has additional shares registered to sell under this agreement and does not intend to register more at this time[74](index=74&type=chunk) [At-the-market Issuances](index=14&type=section&id=At-the-market%20Issuances) This section details the at-the-market equity distribution agreements and the common shares issued through them - On January 14, 2022, the Company entered into a 2022 Equity Distribution Agreement with Canaccord Genuity LLC to sell up to **$5.0 million** of common stock via "at-the-market" offerings[75](index=75&type=chunk) - During the six months ended June 30, 2022, **1,293,657 shares** were issued under the 2022 Distribution Agreement for net proceeds of approximately **$0.9 million**[75](index=75&type=chunk) - The 2020 Distribution Agreement with Canaccord was terminated after all registered shares were fully utilized, yielding **$6.3 million** from **2,179,193 shares** in 2021[77](index=77&type=chunk) [10. Stock-based Compensation](index=15&type=section&id=10.%20Stock-based%20Compensation) This note details the Company's stock incentive plans, unrecognized compensation costs, and stock option activity - The Company has two active stock incentive plans: the 2015 New Employee Incentive Plan (**90,389 shares available**) and the 2020 Stock Incentive Plan (**3,500,000 shares authorized, 627,212 available**)[79](index=79&type=chunk)[80](index=80&type=chunk) - Total unrecognized stock-based compensation cost is approximately **$1.2 million**, expected to be recognized over a weighted average period of **2.63 years**[82](index=82&type=chunk) **Stock Option Activity (Six Months Ended June 30, 2022)** | Metric | Options | Weighted Average Exercise Price | | :-------------------------- | :-------- | :------------------------------ | | Balance as of Dec 31, 2021 | 1,170,890 | $5.01 | | Granted | 13,000 | $0.53 | | Cancelled/forfeited | (17) | $24,705.88 | | Balance as of Jun 30, 2022 | 1,183,873 | $4.60 | [11. COVID-19 Pandemic and CARES Act](index=15&type=section&id=11.%20COVID-19%20Pandemic%20and%20CARES%20Act) This note assesses the impact of the COVID-19 pandemic on the Company's operations and the material impact of the CARES Act - The Company has not experienced a significant impact on its business and operations from the COVID-19 pandemic as of June 30, 2022, but acknowledges potential future disruptions[83](index=83&type=chunk) - The CARES Act had no material impact on the Company's income tax provision for the year ended December 31, 2021, or the six months ended June 30, 2022[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial performance, operational trends, and future outlook, detailing its strategic focus on targeted radiotherapeutics, pipeline progress, recent developments, and liquidity management [Overview](index=16&type=section&id=Overview) This section introduces Plus Therapeutics, Inc. as a pharmaceutical company developing targeted radiotherapeutics for rare cancers, outlining its core technology and lead candidates - Plus Therapeutics, Inc. is a U.S. pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers in adults and children[86](index=86&type=chunk) - The Company's approach involves encapsulating radionuclides (e.g., Rhenium isotopes) within nanoliposomes and microspheres to deliver high, targeted radiation doses to tumors while minimizing exposure to healthy tissues[86](index=86&type=chunk)[88](index=88&type=chunk) - The lead candidate, Rhenium-186 NanoLiposome (186RNL), targets CNS cancers, and Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM) is designed for solid organ cancers[89](index=89&type=chunk) [Pipeline](index=16&type=section&id=Pipeline) This section details the Company's clinical development pipeline, focusing on its lead candidates and their applications in various cancer types [186RNL versus External Beam Radiation Therapy](index=17&type=section&id=186RNL%20versus%20External%20Beam%20Radiation%20Therapy) This section compares 186RNL's targeted radiation delivery to standard external beam radiotherapy, highlighting its potential advantages - 186RNL is a novel injectable radiotherapy designed for targeted, high-dose radiation delivery directly into glioblastoma tumors via convection-enhanced delivery (CED)[94](index=94&type=chunk) - Potential benefits of 186RNL over standard external beam radiotherapy (EBRT) include up to **20 times greater radiation dose**, real-time visualization, more effective treatment of bulk and microscopic disease, reduced healthy tissue exposure, and single-visit treatment[100](index=100&type=chunk) [ReSPECT-GBM Trial for Recurrent GBM](index=17&type=section&id=ReSPECT-GBM%20Trial%20for%20Recurrent%20GBM) This section provides an update on the ReSPECT-GBM trial for glioblastoma, including interim results, regulatory designations, and patient survival data - Glioblastoma (GBM) is the most common, aggressive primary adult brain cancer, with a poor prognosis (average life expectancy **<24 months**) and high recurrence rate (**>90%**)[95](index=95&type=chunk) - Interim Phase 1/2a ReSPECT-GBM trial results suggest 186RNL can deliver up to **740 Gy** of absorbed radiation to tumor tissue without significant toxicities, compared to typical EBRT doses of about **35 Gy**[98](index=98&type=chunk) - The FDA granted Orphan Drug and Fast Track designations to 186RNL for glioblastoma in September 2020[99](index=99&type=chunk) **ReSPECT-GBM Trial OS (as of Nov 2021)** | Patient Group | Mean OS (weeks) | Median OS (weeks) | Patients Alive | | :------------------------------------------------ | :-------------- | :---------------- | :------------- | | All 22 patients | 48.1 | 33.1 | 7 | | Therapeutic dose (>100 Gy) (13 patients) | 64.8 | 47.1 | 7 | | Sub-therapeutic dose (<100 Gy) (9 patients) | 23.9 | 22.3 | 0 | [ReSPECT-LM Clinical Trial for Leptomeningeal Metastases](index=18&type=section&id=ReSPECT-LM%20Clinical%20Trial%20for%20Leptomeningeal%20Metastases) This section details the ReSPECT-LM clinical trial for leptomeningeal metastases, including regulatory clearances and patient enrollment progress - Leptomeningeal metastases (LM) is a rare, highly lethal complication of late-stage cancer, with an average **1-year survival of 7%**[104](index=104&type=chunk) - The FDA cleared the IND application for 186RNL for LM in October 2021 and granted Fast Track designation in November 2021[106](index=106&type=chunk) - The first patient in the ReSPECT-LM Phase 1 clinical trial was treated in Q1 2022, and the first cohort was completed in Q2 2022[106](index=106&type=chunk) [ReSPECT-PBC Clinical Trial for Pediatric Brain Cancer](index=18&type=section&id=ReSPECT-PBC%20Clinical%20Trial%20for%20Pediatric%20Brain%20Cancer) This section outlines plans for investigating 186RNL in pediatric brain cancers, including target indications and regulatory considerations - The Company plans to investigate 186RNL for pediatric brain cancers, specifically high-grade glioma (HGG) and ependymoma, with an IND submission anticipated in late 2022 or early 2023[108](index=108&type=chunk)[111](index=111&type=chunk) - The FDA has indicated that no additional preclinical or toxicology studies are required for this indication[108](index=108&type=chunk) - HGG affects **360-400 children annually** in North America with a **5-year survival rate of ~20%**; Ependymoma affects **~250 children annually** in the U.S[109](index=109&type=chunk)[110](index=110&type=chunk) [Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere Technology](index=19&type=section&id=Rhenium-188%20NanoLiposome%20Biodegradable%20Alginate%20Microsphere%20Technology) This section introduces the new 188RNL-BAM technology, its licensing, and its intended application for solid organ cancers - In January 2022, the Company licensed Biodegradable Alginate Microsphere (BAM) patents and technology from UT Health Science Center at San Antonio to combine with Rhenium NanoLiposome technology[112](index=112&type=chunk) - The new 188RNL-BAM technology is intended for intra-arterial embolization and local delivery of high-dose targeted radiation for solid organ cancers, with liver cancer as the likely initial clinical target[112](index=112&type=chunk)[113](index=113&type=chunk) - Preclinical data showed Technetium-99m-BAM successfully delivered, embolized, and retained radiation in a target organ[113](index=113&type=chunk) [Recent Developments](index=19&type=section&id=Recent%20Developments) This section highlights key recent corporate and clinical developments, including new agreements and financing activities [Services Agreement and Sales Order with Medidata](index=19&type=section&id=Services%20Agreement%20and%20Sales%20Order%20with%20Medidata) This section details the Company's engagement with Medidata for a Synthetic Control Arm® platform in a clinical trial - On March 31, 2022, the Company engaged Medidata to develop a Synthetic Control Arm® (SCA) platform for its Phase 2 186RNL clinical trial in GBM[114](index=114&type=chunk) [UT Health Science Center San Antonio (UTHSA) License Agreement](index=19&type=section&id=UT%20Health%20Science%20Center%20San%20Antonio%20(UTHSA)%20License%20Agreement) This section describes the exclusive global license agreement with UTHSA for 188RNL-BAM technology - On December 31, 2021, the Company secured an exclusive global license from UTHSA for 188RNL-BAM development and commercialization, with future milestone and earn-out payments[116](index=116&type=chunk) [Recent Financings](index=19&type=section&id=Recent%20Financings) This section refers to the liquidity and capital resources section for details on the Company's recent financing activities - This section refers to the "Liquidity and Capital Resources" section for details on recent financing activities[117](index=117&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) This section analyzes the Company's financial performance by detailing changes in key operating and financing expenses over the reporting periods [Research and development expenses](index=20&type=section&id=Research%20and%20development%20expenses) This section analyzes the changes in research and development expenses, attributing increases to specific development costs **Research and Development Expenses (in thousands)** | Expense Type | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | R&D | $2,808 | $1,085 | $4,567 | $2,191 | | Share-based compensation | $23 | $21 | $48 | $42 | | **Total R&D expenses** | **$2,831** | **$1,106** | **$4,615** | **$2,233** | - Total R&D expenses increased by **$1.7 million (154.6%)** for the three months and **$2.4 million (107.5%)** for the six months ended June 30, 2022, primarily due to increased development costs for cGMP 186RNL drug and SCA development[119](index=119&type=chunk)[120](index=120&type=chunk) - The Company expects aggregate R&D expenditures to increase in absolute dollars for the remainder of 2022 due to 186RNL and 188RNL-BAM development[121](index=121&type=chunk) [General and administrative expenses](index=20&type=section&id=General%20and%20administrative%20expenses) This section analyzes the changes in general and administrative expenses, primarily due to higher legal and professional fees **General and Administrative Expenses (in thousands)** | Expense Type | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | G&A | $2,145 | $1,352 | $4,132 | $2,618 | | Share-based compensation | $144 | $117 | $299 | $203 | | **Total G&A expenses** | **$2,289** | **$1,469** | **$4,431** | **$2,821** | - Total G&A expenses increased by **$0.8 million (54.5%)** for the three months and **$1.6 million (56.4%)** for the six months ended June 30, 2022, mainly due to higher legal fees, intellectual property, and other professional expenses[122](index=122&type=chunk) - G&A expenditures are expected to remain generally consistent in 2022, excluding unpredictable litigation costs[123](index=123&type=chunk) [Stock-based compensation expense](index=20&type=section&id=Stock-based%20compensation%20expense) This section details the stock-based compensation expenses, noting increases due to more grants and higher fair values of awards **Stock-based Compensation Expenses (in thousands)** | Expense Type | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $23 | $21 | $48 | $42 | | General and administrative | $144 | $117 | $299 | $203 | | **Total share-based compensation** | **$167** | **$138** | **$347** | **$245** | - Increases in stock-based compensation were primarily due to more grants of stock-based options and higher grant-date fair value of awards[124](index=124&type=chunk) [Financing items](index=21&type=section&id=Financing%20items) This section reviews the Company's financing-related income and expenses, including interest income and expense, and changes in liability instrument fair value **Financing Items (in thousands)** | Item | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Interest income | $19 | $4 | $26 | $8 | | Interest expense | $(181) | $(229) | $(379) | $(476) | | Change in fair value of liability instruments | $0 | $0 | $1 | $2 | | **Total other expense** | **$(162)** | **$(225)** | **$(352)** | **$(466)** | - Interest expense decreased for both periods due to scheduled debt principal repayments that commenced on November 1, 2021[126](index=126&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the Company's financial liquidity, capital needs, and recent financing activities to support ongoing operations and future development [Short-term and long-term liquidity](index=21&type=section&id=Short-term%20and%20long-term%20liquidity) This section evaluates the Company's current liquidity position, including cash and working capital, and its ability to fund operations for the next twelve months **Key Liquidity Measures (in thousands)** | Metric | June 30, 2022 | December 31, 2021 | | :-------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $18,090 | $18,400 | | Current assets | $18,889 | $19,724 | | Current liabilities | $6,971 | $5,870 | | Working capital | $11,918 | $13,854 | - The Company believes its current cash and cash equivalents are sufficient to fund operations for at least the next **twelve months**[128](index=128&type=chunk) - The Company has an ongoing need for additional capital to fund future clinical development and operations, with an inability to raise funds having a material adverse impact and potentially leading to loan default[129](index=129&type=chunk) - Recent financing activities include **$0.9 million** net proceeds from the 2022 Distribution Agreement (**1,293,657 shares**) and **$7.0 million** net proceeds from the 2020 Purchase Agreement (**5,665,000 shares**) during the six months ended June 30, 2022[130](index=130&type=chunk)[132](index=132&type=chunk) [Material Cash Obligations](index=22&type=section&id=Material%20Cash%20Obligations) This section outlines the Company's significant cash commitments, including service agreements, term loan repayments, and operating leases - The Company has cash obligations related to the Medidata Sales Order for the SCA platform, ongoing principal and interest payments for the Term Loan with Oxford (until June 2024), and operating lease payments[136](index=136&type=chunk)[137](index=137&type=chunk) [Operating activities](index=22&type=section&id=Operating%20activities) This section analyzes the net cash used in operating activities, primarily driven by increased research and development expenditures - Net cash used in operating activities increased to **$6.5 million** for the six months ended June 30, 2022, from **$5.4 million** in the same period of 2021, primarily due to increased research and development expenditures[138](index=138&type=chunk)[135](index=135&type=chunk) [Investing activities](index=22&type=section&id=Investing%20activities) This section details the net cash used in investing activities, highlighting increased spending on intangible assets and in-process R&D - Net cash used in investing activities significantly increased to **$715 thousand** for the six months ended June 30, 2022, from **$80 thousand** in 2021[139](index=139&type=chunk)[135](index=135&type=chunk) - This increase was driven by **$250 thousand** for in-process R&D assets from UTHSA and **$500 thousand** for purchases of fixed and intangible assets[139](index=139&type=chunk) [Financing Activities](index=22&type=section&id=Financing%20Activities) This section reviews the net cash provided by financing activities, noting decreases due to lower proceeds from common stock sales and warrant exercises - Net cash provided by financing activities decreased to **$6.9 million** for the six months ended June 30, 2022, from **$14.3 million** in 2021[140](index=140&type=chunk)[135](index=135&type=chunk) - The decrease was primarily due to lower proceeds from common stock sales (**$7.8 million** in 2022 vs. **$12.3 million** in 2021) and no warrant exercise proceeds in 2022 (vs. **$2.0 million** in 2021)[140](index=140&type=chunk)[141](index=141&type=chunk) [Critical Accounting Policies and Significant Estimates](index=22&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Estimates) This section identifies the Company's critical accounting policies and significant estimates, noting no material changes from the prior annual report - Key estimates involve goodwill impairment and fair value measurement of liability-classified warrants using an option pricing model[144](index=144&type=chunk)[145](index=145&type=chunk) - There have been no material changes to critical accounting policies and estimates during the six months ended June 30, 2022, as compared to the Annual Report on Form 10-K for December 31, 2021[146](index=146&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This item is marked as "Not applicable" for the reporting period, indicating no material quantitative or qualitative disclosures regarding market risk - This item is marked as "Not applicable" for the reporting period[147](index=147&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) This section confirms the effectiveness of the Company's disclosure controls and procedures and reports no material changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2022[149](index=149&type=chunk) - There have been no material changes in internal control over financial reporting during the quarter ended June 30, 2022[150](index=150&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II%20OTHER%20INFORMATION) This part provides additional information beyond the financial statements, covering legal proceedings, updated risk factors, and a comprehensive list of exhibits [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) This section provides an update on the ongoing legal proceeding where the Company is a defendant in a lawsuit alleging false representations regarding a UK manufacturing facility, with the Company vigorously defending the case - The Company is a defendant in a lawsuit filed by Lorem Vascular, Pte. Ltd. on June 22, 2021, alleging false representations regarding a UK manufacturing facility and its certifications[151](index=151&type=chunk) - Lorem claims at least **$6.0 million** in compensatory damages; the Company believes the claim is without merit and is vigorously defending the case[151](index=151&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) This section highlights additional and updated risk factors, primarily focusing on the Company's non-compliance with Nasdaq's minimum bid price requirement and the potential consequences of delisting - The Company received a Nasdaq notice on May 24, 2022, for non-compliance with the minimum bid price requirement (**$1.00 per share**) and has until November 21, 2022, to regain compliance[155](index=155&type=chunk) - Failure to regain compliance could lead to delisting from Nasdaq, which would seriously harm stock liquidity, market price, and the Company's ability to raise capital[154](index=154&type=chunk)[156](index=156&type=chunk) - This section supplements the risk factors discussed in the Annual Report on Form 10-K for the year ended December 31, 2021, with no other material changes noted[152](index=152&type=chunk)[153](index=153&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section provides a comprehensive index of exhibits filed with the Form 10-Q, including corporate governance documents, incentive plans, and certifications, detailing their filing status and incorporation by reference - This section provides a comprehensive index of exhibits filed with the Form 10-Q, including corporate governance documents, incentive plans, and certifications (e.g., Sarbanes-Oxley Act certifications)[159](index=159&type=chunk) - Certifications furnished in Exhibit 32.1 are deemed to accompany the Form 10-Q but are not "filed" for Section 18 purposes unless specifically incorporated by reference[160](index=160&type=chunk)

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q1 2022 Earnings Conference Call April 21, 2022 5:00 PM ET Company Participants Marc Hedrick - President and CEO Norman LaFrance - CMO and SVP Andrew Sims - VP and CFO Conference Call Participants Ed Woo - Ascendiant Capital Sean Lee - H.C. Wainwright Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics First Quarter 2022 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for your qu ...