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PLUS THERAPEUTICS, INC.

For the period ended Dec 31, 2025. Filed Mar 12, 2026.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2025 · Filed Mar 12, 2026

CNSY$0.57-11.3%Stored close · as of Nov 9, 2026

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Contents

Table of Contents

ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2025

TABLE OF CONTENTS

Page
PART I
Item 1.Business5
Item 1A.Risk Factors26
Item 1B.Unresolved Staff Comments53
Item IC.Cybersecurity53
Item 2.Properties54
Item 3.Legal Proceedings54
Item 4.Mine Safety Disclosures54
PART II
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities55
Item 6.[Reserved]55
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations56
Item 7A.Quantitative and Qualitative Disclosures About Market Risk69
Item 8.Financial Statements and Supplementary Data70
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure104
Item 9A.Controls and Procedures104
Item 9B.Other Information104
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspection105
PART III
Item 10.Directors, Executive Officers and Corporate Governance105
Item 11.Executive Compensation105
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters105
Item 13.Certain Relationships and Related Transactions, and Director Independence105
Item 14.Principal Accounting Fees and Services105
PART IV
Item 15.Exhibits, Financial Statement Schedules106

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This report contains certain statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

These statements include, without limitation, statements about our anticipated expenditures, including research and development, and general and administrative expenses; our intent or ability to regain and maintain compliance with Nasdaq listing standards; our strategic collaborations and license agreements, intellectual property, U.S. Food and Drug Administration and European Medicines Agency approvals and interactions and government regulation; the potential size of the market for our product candidates; our research and development efforts; results from our preclinical and clinical studies and the implications of such results regarding the efficacy or safety of our product candidates; the safety profile, pathways, and efficacy of our product candidates and formulations; anticipated advantages of our product candidates over other products available in the market and being developed; the populations that will most benefit from our product candidates and indications that will be pursued with each product candidate; anticipated progress in our current and future clinical trials; plans and strategies to create novel technologies; our IP strategy; competition; future development and/or expansion of our product candidates and therapies in our markets; sources of competition for any of our product candidates; our pipeline; our ability to generate product or development revenue and the sources of such revenue; our ability to effectively manage our gross profit margins; our ability to obtain and maintain regulatory approvals; expectations as to our future performance; our ability to satisfy our obligations under the terms of our capital raising transactions including registering shares issuable in such transactions; portions of the “Liquidity and Capital Resources” section of this Annual Report on Form 10-K (“Form 10-K”) including our potential need for additional financing and the availability thereof; our ability to integrate into our business and operations, develop, fully utilize and monetize acquired assets; our ability to continue as a going concern; our ability to repay or refinance some or all of our outstanding indebtedness and our ability to raise capital in the future; our ability to transfer the drug and medical device product manufacturing to a contract drug and medical device manufacturing organization; the potential enhancement of our cash position through development, marketing, and licensing arrangements; our ability to timely and efficiently launch our CNSide® Cerebrospinal Fluid Tumor Cell Enumeration test (the “CNSide Test”), and expand the CNSide platform for Immunocytochemistry (“ICC”), Fluorescence In Situ Hybridization (“FISH”) and Next Generation Sequencing (“NGS”); receipt of grant revenue; and a material security breach or cyber security attack affecting our operations and property. The forward-looking statements included in this report could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties and other factors that include, but are not limited to, the risks described under Risk Factors” included below.

We encourage you to read the risks described under “Risk Factors” and elsewhere in this report carefully. We caution you not to place undue reliance on the forward-looking statements contained in this report. These statements, like all statements in this report, speak only as of the date of this report (unless an earlier date is indicated) and we undertake no obligation to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless we have an obligation under U.S. federal securities laws to do so. Such forward-looking statements are not guarantees of future performance.

Part I

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