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 ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Presents Plus Therapeutics, Inc.'s unaudited condensed financial statements and detailed notes [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Condensed Balance Sheet Highlights (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $21,239 | $18,400 | | Total current assets | $22,104 | $19,724 | | Total assets | $24,516 | $21,981 | | Total current liabilities | $4,921 | $5,870 | | Total liabilities | $9,874 | $11,145 | | Total stockholders' equity | $14,642 | $10,836 | - Total assets increased by **$2.535 million**, and total stockholders' equity increased by **$3.806 million** from December 31, 2021, to March 31, 2022[14](index=14&type=chunk) [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Condensed Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,785 | $1,127 | | General and administrative | $2,141 | $1,352 | | Total operating expenses | $3,926 | $2,479 | | Operating loss | $(3,926) | $(2,479) | | Net loss | $(4,116) | $(2,720) | | Net loss per share, basic and diluted | $(0.19) | $(0.33) | | Weighted average shares | 21,507,061 | 8,267,901 | - Net loss increased by **$1.396 million (51.3%)** year-over-year, primarily driven by higher operating expenses[16](index=16&type=chunk) - Net loss per share decreased from **$(0.33)** to **$(0.19)** despite a higher net loss, due to a significant increase in the weighted average shares outstanding[16](index=16&type=chunk) [Condensed Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) Changes in Stockholders' Equity (in thousands) | Item | Three Months Ended March 31, 2022 | | :-------------------------- | :-------------------------------- | | Balance at December 31, 2021 | $10,836 | | Stock-based compensation | $180 | | Sale of common stock, net | $7,742 | | Net loss | $(4,116) | | Balance at March 31, 2022 | $14,642 | - Total stockholders' equity increased by **$3.806 million** from December 31, 2021, to March 31, 2022, primarily due to net proceeds from common stock sales (**$7.742 million**) partially offset by the net loss (**$4.116 million**)[19](index=19&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,876) | $(3,006) | | Net cash used in investing activities | $(577) | $(84) | | Net cash provided by financing activities | $7,292 | $9,191 | | Net increase in cash and cash equivalents | $2,839 | $6,101 | | Cash and cash equivalents at end of period | $21,239 | $14,447 | - Net cash used in operating activities increased by **$0.870 million** year-over-year, reflecting increased expenditures[21](index=21&type=chunk) - Net cash provided by financing activities decreased by **$1.899 million** year-over-year, primarily due to lower proceeds from common stock sales and no warrant exercises in 2022[21](index=21&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) - 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) - The Company incurred a net loss of **$4.1 million** for Q1 2022, with an accumulated deficit of **$451.0 million**, and used **$3.9 million** in cash for operating activities[27](index=27&type=chunk) - The Company believes its current cash and cash equivalents (**$21.2 million**) will be sufficient to fund operations for at least the **next 12 months** but continues to seek additional capital[28](index=28&type=chunk)[14](index=14&type=chunk) - As of March 31, 2022, **$3.6 million** principal was outstanding under the Term Loan, excluding a **$3.2 million** final payment fee, and the Company was in compliance with all debt covenants[36](index=36&type=chunk) - The Company entered into a Statement of Work with Medidata Solutions, Inc. on March 31, 2022, to build a **Synthetic Control Arm® (SCA)** platform for its Phase 2 clinical trial of 186RNL in GBM, with managed services fees of **$1.45 million** and a contingent fee of **$150,000**[48](index=48&type=chunk)[49](index=49&type=chunk) - The Company is a defendant in a lawsuit by Lorem Vascular, Pte. Ltd. claiming at least **$6 million** in damages for alleged false representations regarding a UK manufacturing facility, which the Company is vigorously defending[54](index=54&type=chunk) - The Company licensed **BAM patents and technology** from UT Health Science Center at San Antonio on December 31, 2021, and **radiolabeled nanoliposome technology** from NanoTx, Corp. on March 29, 2020[56](index=56&type=chunk)[58](index=58&type=chunk) - During Q1 2022, the Company issued **5,665,000 shares** of common stock under the Lincoln Park Purchase Agreement for **$7.0 million** net proceeds and **1,022,610 shares** under the 2022 Distribution Agreement for **$0.7 million** net proceeds[70](index=70&type=chunk)[71](index=71&type=chunk) - Total unrecognized stock-based compensation cost is approximately **$1.3 million**, expected to be recognized over a weighted average period of **2.79 years**[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion and analysis of Q1 2022 financial condition and results of operations [Overview](index=16&type=section&id=Overview) - Plus Therapeutics is developing innovative, **targeted radiotherapeutics** for rare and difficult-to-treat cancers, utilizing novel drug formulations like **Rhenium isotopes** within nanoliposomes and microspheres[83](index=83&type=chunk)[85](index=85&type=chunk) - The lead radiotherapeutic candidate, **Rhenium-186 NanoLiposome (186RNL)**, targets **CNS cancers** (recurrent glioblastoma, leptomeningeal metastases, pediatric brain cancers)[86](index=86&type=chunk) - The recently acquired **Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (188RNL-BAM)** is designed to treat **solid organ cancers**, including primary and secondary liver cancers[86](index=86&type=chunk)[109](index=109&type=chunk) - Interim results from the **Phase 1/2a ReSPECT-GBM trial** for recurrent glioblastoma show 186RNL delivered up to **740 Gy** of absorbed radiation to tumor tissue without significant toxicities, with a **statistically significant difference in overall survival** for patients receiving a presumed therapeutic dose (**>100 Gy**)[95](index=95&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - The FDA granted **Orphan Drug** and **Fast Track designations** to **186RNL** for glioblastoma and Fast Track designation for leptomeningeal metastases, with the **ReSPECT-LM Phase 1 clinical trial** initiating in Q1 2022[96](index=96&type=chunk)[103](index=103&type=chunk) - The Company plans to submit an **IND application** for **186RNL** for **pediatric brain cancer** (high-grade glioma and ependymoma) in late 2022 or early 2023[108](index=108&type=chunk) - A Statement of Work was entered with Medidata Solutions, Inc. on March 31, 2022, to build a **Synthetic Control Arm® (SCA)** platform for the **186RNL Phase 2 GBM clinical trial**[111](index=111&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Operating Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change (YoY) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Research and development | $1,785 | $1,127 | +$658 (58.4%) | | General and administrative | $2,141 | $1,352 | +$789 (58.4%) | | Total operating expenses | $3,926 | $2,479 | +$1,447 (58.4%) | - The increase in **R&D expenses** was primarily due to increased development costs for **186RNL** (**$0.5 million**), professional expenses (**$0.1 million**), and personnel expenses (**$0.1 million**) as the company plans for a pivotal trial[116](index=116&type=chunk) - **General and administrative expenses** rose mainly due to a **$0.6 million** increase in legal, intellectual property, and other professional expenses, and a **$0.2 million** increase in personnel-related expenses[118](index=118&type=chunk) Financing Items (in thousands) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | Change (YoY) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Interest income | $7 | $4 | +$3 | | Interest expense | $(198) | $(247) | +$49 | | Change in fair value of liability instruments | $1 | $2 | -$1 | | Total other expense | $(190) | $(241) | +$51 | - **Interest expense decreased** due to scheduled debt principal repayments that commenced in November 2021[121](index=121&type=chunk)[122](index=122&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) Key Liquidity Measures (in thousands) | Metric | March 31, 2022 | December 31, 2021 | | :------------------------ | :------------- | :---------------- | | Cash and cash equivalents | $21,239 | $18,400 | | Current assets | $22,104 | $19,724 | | Current liabilities | $4,921 | $5,870 | | Working capital | $17,183 | $13,854 | - The Company believes its cash and cash equivalents of **$21.2 million** at March 31, 2022, will be sufficient to fund operations for at least the **next twelve months**[123](index=123&type=chunk) - During Q1 2022, the Company raised approximately **$7.0 million** in net proceeds from common stock sales under the Lincoln Park Purchase Agreement and **$0.7 million** under the 2022 Distribution Agreement with Canaccord Genuity LLC[125](index=125&type=chunk)[127](index=127&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(3,876) | $(3,006) | | Net cash used in investing activities | $(577) | $(84) | | Net cash provided by financing activities | $7,292 | $9,191 | | Net increase in cash and cash equivalents | $2,839 | $6,101 | - Material cash obligations include **$1.45 million** in managed services fees to Medidata (plus a **$150,000** contingent fee), ongoing principal and interest payments on the Term Loan, and operating lease payments[131](index=131&type=chunk)[132](index=132&type=chunk) [Critical Accounting Policies and Significant Estimates](index=22&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Estimates) - The Company's critical accounting policies and estimates, including those for goodwill impairment and fair value measurement of liability classified warrants, remain consistent with its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, with **no material changes** in Q1 2022[137](index=137&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No material quantitative or qualitative disclosures regarding market risk for the reported period - This item is not applicable for the Company[142](index=142&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes in internal control - Disclosure controls and procedures were **effective** at the reasonable assurance level as of March 31, 2022[144](index=144&type=chunk) - **No material changes** in internal control over financial reporting occurred during the quarter ended March 31, 2022[145](index=145&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) Details an ongoing lawsuit against Plus Therapeutics, Inc. by Lorem Vascular, Pte. Ltd. claiming at least $6 million - Plus Therapeutics, Inc. is a defendant in a lawsuit filed by Lorem Vascular, Pte. Ltd. on June 22, 2021[146](index=146&type=chunk) - The complaint alleges false representations regarding a UK manufacturing facility purchased by Lorem, claiming at least **$6,000,000** in compensatory damages and operational costs[146](index=146&type=chunk) - The Company believes the Lorem Claim is **without merit** and is vigorously defending the case[146](index=146&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) Refers to the Annual Report on Form 10-K for risk factors, confirming no material changes this quarter - There have been **no material changes** to the risk factors included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021[147](index=147&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed as part of this Form 10-Q, including agreements, certifications, and XBRL data - Key exhibits include the **Distribution Agreement** with Canaccord Genuity LLC, **Medidata Services Agreement and Statement of Work**, and **certifications** from the Principal Executive Officer and Principal Financial and Accounting Officer[150](index=150&type=chunk) - The filing also includes **Inline XBRL Instance**, **Schema**, **Calculation**, **Definition**, **Label**, and **Presentation Linkbase Documents**, along with the **Cover Page Interactive Data File**[150](index=150&type=chunk)[151](index=151&type=chunk)

Financial Data and Key Metrics Changes - As of December 31, 2021, cash and cash equivalents were $18.4 million, compared to $8.3 million as of December 31, 2020, indicating a significant increase in liquidity [38] - Cash used in operations for the year ended December 31, 2021, was $10.3 million, up from $8.4 million in 2020, reflecting increased operational activities [38] - Net loss for 2021 was $13.4 million, compared to a net loss of $8.2 million in 2020, primarily due to increased R&D and G&A expenses [42] Business Line Data and Key Metrics Changes - Research and development expenses rose to $5.3 million in 2021 from $2.7 million in 2020, driven by continued development of RNL to GMP standards [39] - General and administrative expenses increased to $6.9 million in 2021 from $6.4 million in 2020, attributed to new patent filings and professional fees related to the BAM transaction [40] Market Data and Key Metrics Changes - The initial indication for RNL targets recurrent glioblastoma, with an estimated 30,000 patients annually in the U.S. and a similar number in Europe, highlighting a significant market opportunity [8] - The ReSPECT-GBM trial has shown promising interim data, with a mean overall survival of 38 weeks and a median of 50 weeks for treated patients [15] Company Strategy and Development Direction - The company aims to become a global leader in precision targeted radio therapeutics for cancer, focusing on the development of RNL and expanding its pipeline with new technologies like BAM [7][21] - An agreement with the University of Texas for a worldwide exclusive license to develop biodegradable alginate microspheres (BAM) was announced, which will enhance the company's therapeutic offerings [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for RNL to address significant unmet needs in cancer treatment, particularly in recurrent glioblastoma and leptomeningeal metastases [27][34] - The company plans to meet with the FDA midyear to propose a Phase 2 clinical plan and explore the use of real-world data to facilitate trial enrollment [28][44] Other Important Information - The company raised approximately $28.5 million of capital in early 2022, strengthening its balance sheet and providing over two years of operating cash [38] - The company is on track to deliver GMP RNL by mid-2022, with ongoing CMC activities [20][43] Q&A Session Summary Question: How much of a barrier to potential adoption would physician training be? - Management acknowledged a barrier but stated it is solvable, emphasizing that existing neurosurgical techniques can be leveraged for catheter placement [50][51] Question: Can you provide additional color on a regulatory precedent for using a synthetic control arm? - Management noted that real-world data and synthetic control arms have established precedents with the FDA, citing successful studies in ovarian cancer and glioblastoma [55][56] Question: Given the greater overall survival rate in higher dose cohorts, what is the dosing strategy for the next trial? - The dosing plan includes a recommended Phase 2 dose of 8.8 CC and approximately 21 millicuries, targeting 50% to 75% of patients with recurrent glioblastoma [62][63] Question: Can you do a registration study with a single arm of 100 patients? - Management indicated that approximately 100 patients is the expected size for the trial, with fast track status from the FDA potentially facilitating the process [68][70] Question: What is the rationale behind the BAM product? - Management highlighted BAM's mature delivery technology and its alignment with existing RNL technology, providing a logical expansion of the company's capabilities [84][86]

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, 2021 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. (previously known as Cytori Therapeutics, Inc.) (Exact name of Registrant as Specified in Its Charter) ...

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2021 Earnings Conference Call October 21, 2021 5:00 PM ET Company Participants Marc Hedrick - President and Chief Executive Officer Andrew Sims - Chief Financial Officer Conference Call Participants Jason Mccarthy - Maximum Group Ed Woo - Ascendiant Capital Operator Good afternoon, ladies and gentlemen, and welcome to the Plus Therapeutics Third Quarter 2021 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be ope ...

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 September 30, 2021 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 jur ...

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q2 2021 Earnings Conference Call July 22, 2021 5:00 PM ET Company Participants Marc Hedrick - CEO Andrew Sims - CFO Conference Call Participants Sean Lee - H.C. Wainwright Ed Woo - Ascendiant Capital Emad Samad - Octavian Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Second Quarter 2021 Results Call. At this time, all participants have been placed in a listen-only mode, and floor will be open for your questions following the presentatio ...

[PART I FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Unaudited H1 2021 financials show increased assets, a **$5.5 million net loss**, and raise going concern doubts [Consolidated Condensed Balance Sheets](index=4&type=section&id=Consolidated%20Condensed%20Balance%20Sheets) As of June 30, 2021, cash, total assets, and equity significantly increased due to stock issuances Balance Sheet Summary (in thousands) | Metric | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $17,161 | $8,346 | | Total current assets | $18,001 | $9,175 | | Total assets | $20,834 | $12,105 | | **Liabilities & Equity** | | | | Total current liabilities | $8,354 | $8,539 | | Total liabilities | $8,889 | $9,074 | | Total stockholders' equity | $11,945 | $3,031 | [Consolidated Condensed Statements of Operations](index=5&type=section&id=Consolidated%20Condensed%20Statements%20of%20Operations) Net losses for Q2 and H1 2021 increased to **$2.8 million** and **$5.5 million**, driven by higher R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2021 | Q2 2020 | H1 2021 | H1 2020 | | :--- | :--- | :--- | :--- | :--- | | Development revenues | $0 | $185 | $0 | $303 | | Research and development | $1,106 | $327 | $2,233 | $1,268 | | General and administrative | $1,469 | $1,429 | $2,821 | $3,047 | | Loss from operations | $(2,575) | $(2,352) | $(5,054) | $(4,793) | | Net loss | $(2,800) | $(1,839) | $(5,520) | $(2,926) | | Net loss per share | $(0.25) | $(0.45) | $(0.56) | $(0.74) | [Consolidated Condensed Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Condensed%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity increased to **$11.9 million** by June 30, 2021, from stock sales and warrant exercises, offset by net loss - During the first half of 2021, the company raised approximately **$7.1 million** from the sale of common stock, net of offering costs, and an additional **$2.0 million** from the exercise of warrants[18](index=18&type=chunk) - In the second quarter of 2021, an additional **$5.1 million** was raised from the sale of common stock, net of offering costs[18](index=18&type=chunk) [Consolidated Condensed Statements of Cash Flows](index=7&type=section&id=Consolidated%20Condensed%20Statements%20of%20Cash%20Flows) H1 2021 saw **$5.4 million** net cash used in operations, offset by **$14.3 million** from financing, increasing cash to **$17.2 million** Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,405) | $(2,911) | | Net cash used in investing activities | $(80) | $(423) | | Net cash provided by (used in) financing activities | $14,300 | $(4,992) | | **Net increase (decrease) in cash** | **$8,815** | **$(8,326)** | - Financing activities in H1 2021 included **$12.3 million** in net proceeds from the sale of common stock and **$2.0 million** from the exercise of warrants[20](index=20&type=chunk) [Notes to Consolidated Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Condensed%20Financial%20Statements) Notes detail accounting policies, liquidity concerns raising substantial doubt about going concern due to recurring losses - The company incurred a net loss of **$5.5 million** for the six months ended June 30, 2021, and had an accumulated deficit of **$439.0 million**, raising substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk) - The company raised **$6.3 million** (net) through its At-the-Market (ATM) agreement with Canaccord and **$6.0 million** (net) through its purchase agreement with Lincoln Park during the first six months of 2021[30](index=30&type=chunk)[31](index=31&type=chunk) - On June 22, 2021, the company was named as a defendant in a lawsuit by Lorem Vascular, Pte. Ltd., which is seeking at least **$6.0 million** in damages, though the company believes the claims are without merit[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical-stage drug development, increased R&D, precarious liquidity, and reliance on recent financing [Overview and Pipeline](index=17&type=section&id=Overview%20and%20Pipeline) Plus Therapeutics focuses on its RNL nanotechnology platform for rGBM, currently in Phase 1 trials with FDA designations - The company's lead drug, Rhenium NanoLiposomes (RNL), is being developed for recurrent glioblastoma (rGBM) and is supported by a **$3 million** award from NIH/NCI[86](index=86&type=chunk) - RNL is currently in a Phase 1 dose-finding clinical trial (ReSPECT™), which has completed its seventh dose escalation cohort and is proceeding to an eighth cohort with a **40% increase** in drug volume and radiation dose[92](index=92&type=chunk) - In September 2020, the FDA granted both Orphan Drug and Fast Track designations to RNL for the treatment of glioblastoma[93](index=93&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Q2 and H1 2021 saw no revenue, significant increases in R&D expenses for RNL development, and stable G&A Research and Development Expenses (in thousands) | Period | 2021 | 2020 | Change | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $1,106 | $327 | +$779 | | Six Months Ended June 30 | $2,233 | $1,268 | +$965 | - The increase in R&D expenses for both the three and six-month periods was primarily due to increased expenditures related to the development of RNL in compliance with cGMP requirements[101](index=101&type=chunk) - General and administrative expenses decreased by **$0.2 million** for the six months ended June 30, 2021, compared to 2020, mainly due to a **$0.6 million** reduction in legal expenses, offset by increases in stock-based compensation and consulting services[104](index=104&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity raises going concern doubt, relying on **$12.3 million** in H1 2021 equity financing to offset losses Key Liquidity Measures (in thousands) | Metric | June 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $17,161 | $8,346 | | Working capital | $9,647 | $636 | - During H1 2021, the company issued **2,179,193 shares** under its ATM agreement for net proceeds of **$6.3 million**, exhausting the program[114](index=114&type=chunk) - During H1 2021, the company issued **2,262,686 shares** under its purchase agreement with Lincoln Park for net proceeds of **$6.0 million**[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that quantitative and qualitative disclosures about market risk are not applicable - The company has determined that quantitative and qualitative disclosures about market risk are not applicable[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[131](index=131&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended June 30, 2021[132](index=132&type=chunk) [PART II OTHER INFORMATION](index=24&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a new lawsuit seeking at least **$6.0 million** in damages over alleged false representations, which it intends to defend - On June 22, 2021, the company was sued by Lorem Vascular, Pte. Ltd. in the District Court for the District of Delaware[133](index=133&type=chunk) - The lawsuit alleges false representations regarding a UK manufacturing facility sold to Lorem in 2019 and seeks at least **$6,000,000** in damages[133](index=133&type=chunk) - The company believes the claims are without merit, intends to vigorously defend the case, and has not accrued any liability as of June 30, 2021[133](index=133&type=chunk) [Item 1A. Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K - There have been no material changes to the risk factors included in the company's Annual Report on Form 10-K for the year ended December 31, 2020[134](index=134&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including officer certifications and XBRL data files - This section lists all exhibits filed with the Form 10-Q, including officer certifications (Exhibits 31.1, 31.2, 32.1) and interactive data files (Exhibits 101 and 104)[137](index=137&type=chunk)