[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)

Financial Data and Key Metrics Changes - As of March 31, 2021, cash and cash equivalents were $14.4 million, an increase from $8.3 million as of December 31, 2020 [21] - Cash used in operations for Q1 2021 was approximately $3 million, compared to $1.5 million in Q1 2020, primarily due to timing differences in accounts payable and accrued expenses [21] - Revenues for Q1 2021 were approximately $118,000, a decrease attributed to the closeout of the BARDA contract [22] - Net loss for Q1 2021 was $2.7 million, compared to a net loss of $1.1 million in Q1 2020, consistent year on year when excluding book gains on warrants reported in the previous year [23] Business Line Data and Key Metrics Changes - Research and development expenses were $1.1 million for Q1 2021, up from $0.9 million in Q1 2020, mainly due to additional RNL development costs [22] - General and administrative expenses decreased to $1.12 million in Q1 2021 from $1.6 million in Q1 2020, driven by reduced professional fees and recruiting expenses [22] Market Data and Key Metrics Changes - The lead drug, RNL, targets recurring glioblastoma, affecting approximately 12,000 patients in the US and a similar number in the EU [8] - The ongoing RESPECT trial is evaluating RNL's safety and efficacy, with interim results showing it can deliver significantly higher radiation doses compared to standard treatments [12][14] Company Strategy and Development Direction - The company aims to expand RNL's clinical development into additional indications, including leptomeningeal metastases and pediatric brain cancers, with pre-IND meetings planned for 2021 [18][19] - A Master Services Agreement was entered into with Piramal Pharma Solutions for the development and manufacturing of RNL, indicating a focus on establishing a robust supply chain [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing RESPECT trial, noting that the trial is progressing well and that they are on track to complete pivotal trial planning with the FDA [25] - The company is focused on maximizing clinical outcomes through enhanced delivery mechanisms and is preparing for potential registration trials by the end of 2021 [31][32] Other Important Information - The company is developing a mathematical model to predict the distribution of RNL, which may enhance delivery accuracy in future trials [17] - Management highlighted the importance of patient and physician collaboration in clinical trials, emphasizing their commitment to addressing rare cancers [42] Q&A Session Summary Question: Regarding the RESPECT study and Cohort Six - Management indicated that the absence of dose-limiting toxicity in Cohort Six suggests that the doses used may be taken forward, but they are also considering increasing flow rates to target microscopic disease [28] Question: Timeline for the next update on Cohort Six - Management expects to provide updates either before the next earnings call or during it, as patient screening is ongoing [30] Question: CMC timeline and drug readiness for pivotal study - Management confirmed they are on track to have the drug ready for registration trials by the end of 2021, with preparations for both Phase 1 and Phase 2 supply chains [31][32] Question: Design thoughts for the next initial clinical study - Management stated that the Phase 1/2 trial is fairly locked in, with overall survival as a primary endpoint, and they are considering a synthetic control arm for Phase 3 [34] Question: Status of clinical sites and COVID-19 impact - Management reported that patient screening is back to normal, and they are considering expanding trial sites for future cohorts [39]

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, 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 jurisdi ...

Corporate Presentation February 2021 1 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statement in this document that is not a historical fact is a "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," " ...