Plus Therapeutics (PSTV) Q1 2026 loss highlights cash burn and going concern risk
Plus Therapeutics, Inc. reported a net loss of $6.9 million for the three months ended March 31, 2026, on grant revenue of $1.0 million, reflecting heavy research and administrative spending as it develops CNS cancer diagnostics and radiopharmaceuticals.
Cash and cash equivalents were $3.0 million with net cash used in operations of $6.2 million, and management states there is substantial doubt about the company’s ability to continue as a going concern without additional financing. Stockholders’ equity increased to $12.0 million, supported by a January 2026 public offering and a 1‑for‑25 reverse stock split that helped the company regain compliance with Nasdaq’s minimum bid requirement.
Positive
- Balance sheet strengthened by equity raise: A January 2026 underwritten public offering generated approximately $13.9 million in net proceeds, helping lift stockholders’ equity to $12.0 million as of March 31, 2026 and supporting ongoing development programs.
Negative
- Going concern uncertainty and high cash burn: Management states substantial doubt about the ability to continue as a going concern, with Q1 2026 net loss of $6.9 million, net cash used in operations of $6.2 million, and only $3.0 million in cash on hand.
- Ongoing Nasdaq compliance risk: Although the company has regained the minimum bid requirement and currently meets Nasdaq’s stockholders’ equity rule, it remains under monitoring through August 22, 2026, and a future shortfall could trigger a delisting process.
Insights
Q1 2026 shows improved balance sheet but persistent funding risk.
Plus Therapeutics posted a Q1 2026 net loss of $6.9 million on grant revenue of $1.0 million, driven by research and development of CNS radiopharmaceuticals and higher general and administrative costs. Operating cash burn was $6.2 million.
After a January 2026 public offering yielding about $13.9 million net, cash stood at $3.0 million, investments at $12.1 million, and stockholders’ equity at $12.0 million. Despite this, management explicitly raises substantial doubt about its ability to continue as a going concern without more capital.
The filing details heavy reliance on external financing tools, including a Lincoln Park equity facility and prior structured warrant deals, alongside Nasdaq monitoring of the stockholders’ equity requirement through August 22, 2026. Subsequent filings may clarify whether additional equity draws or partnerships materially extend the company’s cash runway.
Key Figures
Key Terms
going concern financial
reverse stock split financial
available-for-sale securities financial
Clinical Laboratory Improvement Amendments regulatory
Lincoln Park Purchase Agreement financial
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
OR
For the transition period from to
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(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financing accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of May 13, 2026, there were
PLUS THERAPEUTICS, INC.
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FINANCIAL INFORMATION |
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Consolidated Financial Statements (Unaudited) |
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Condensed Consolidated Balance Sheets |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Quantitative and Qualitative Disclosures about Market Risk |
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Controls and Procedures |
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PART II. |
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OTHER INFORMATION |
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Legal Proceedings |
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Item 1A. |
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Risk Factors |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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Exhibits |
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2
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Quarterly Report”) and the exhibits incorporated herein by reference contain “forward-looking statements” which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements other than statements of historical fact constitute “forward-looking statements.” These forward-looking statements do not constitute guarantees of future performance. These forward-looking statements may be identified by terms such as “intend,” “expect,” “project,” “believe,” “anticipate,” “initiate,” “will,” “should,” “would,” “could,” “may,” “designed,” “potential,” “evaluate,” “hypothesize,” “plan,” “progressing,” “proceeding,” “exploring,” “opportunity,” “hopes,” “suggest,” and similar expressions, or the negative of such expressions. 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 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; our research and development efforts; the 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; future development and/or expansion of our product candidates and therapies in our markets; portions of the “Liquidity and Capital Resources” section of this Quarterly Report including our potential need for additional financing and the availability thereof.
Our actual results may differ, including materially, from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, the following: our ability to remain listed on Nasdaq; the early stage of our product candidates and therapies, the results of our research and development activities, including uncertainties relating to the clinical trials of our product candidates and therapies; sources of competition for any of our product candidates; the potential size of the market for 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; 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”); receipt of grant revenue; material security breaches or cybersecurity attacks affecting our operations and property; and our liquidity and capital resources and our ability to raise additional cash, the outcome of our partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to us, market conditions, product performance, potential litigation, and competition within the radiotherapeutics, and more generally, oncological medicine fields, among others. The forward-looking statements included in this Quarterly Report are also subject to a number of additional material risks and uncertainties, including but not limited to the risks described under “Part I – Item 1A – Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (the “SEC”) on March 12, 2026 and under “Part II – Item 1A – Risk Factors” in this Quarterly Report. These risks and uncertainties could cause actual results to differ materially from expectations or those expressed in these forward-looking statements.
We caution you not to place undue reliance on the forward-looking statements contained in this Quarterly 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 the Company undertakes no obligation to update or revise the statements except as required by law. Such forward-looking statements are not guarantees of future performance.
3
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
PLUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(in thousands, except share and par value data)
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March 31, 2026 |
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December 31, 2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash and cash equivalents |
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— |
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Investments |
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Grant receivable |
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Other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Goodwill |
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Intangible assets, net |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
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$ |
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Investor liability pursuant to Letter Agreement |
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— |
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Operating lease liability |
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Deferred grant liability |
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Line of credit |
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Other liabilities |
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Total current liabilities |
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Noncurrent operating lease liability |
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— |
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Total liabilities |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity (deficit): |
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Preferred stock, $ |
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— |
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— |
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Common stock, $ |
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Treasury stock (at cost), |
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( |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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See Accompanying Notes to these Condensed Consolidated Financial Statements
4
Table of Contents
PLUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(in thousands, except share and per share data)
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For the Three Months Ended March 31, |
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2026 |
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2025 |
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Grant revenue |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Operating loss |
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( |
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( |
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Other income (expense): |
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Interest income |
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Interest expense |
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( |
) |
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( |
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Financing expenses |
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— |
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( |
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Warrant issuance costs |
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— |
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( |
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Change in fair value of derivative instruments |
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— |
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( |
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Total other income (expense) |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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Per share information |
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Net loss per share of common stock – basic and diluted |
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$ |
( |
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$ |
( |
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Weighted average number of shares of common stock outstanding – basic and diluted |
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See Accompanying Notes to these Condensed Consolidated Financial Statements
5
Table of Contents
PLUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY/(DEFICIT)
(UNAUDITED) (In thousands, except share data)
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Convertible |
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Additional |
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Total |
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preferred stock |
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Common stock |
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Treasury Stock |
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paid-in |
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Accumulated |
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stockholders’ |
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Shares |
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Amount |
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Shares |
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Amount |
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Shares |
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Amount |
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capital |
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deficit |
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(deficit)/equity |
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Balance at December 31, 2024 |
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$ |
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— |
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$ |
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( |
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$ |
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( |
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$ |
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$ |
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( |
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$ |
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( |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of pre-funded warrants |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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— |
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Exercise of Series B Warrants from May 2024 PIPE |
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— |
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— |
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— |
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— |
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— |
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— |
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Exchange of warrants for notes payable |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Issuance of common stock, pre-funded warrants and warrants for debt repayment |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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|
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— |
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( |
) |
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( |
) |
Balance at March 31, 2025 |
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$ |
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— |
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$ |
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( |
) |
$ |
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( |
) |
$ |
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$ |
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( |
) |
$ |
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( |
) |
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Balance at December 31, 2025 |
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$ |
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— |
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$ |
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( |
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$ |
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( |
) |
$ |
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$ |
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( |
) |
$ |
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|||||
Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Cancellation of common stock |
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— |
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— |
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( |
) |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock upon vesting of RSUs |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock upon public offering, net of issuance costs |
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— |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance at March 31, 2026 |
|
|
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$ |
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— |
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$ |
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|
( |
) |
$ |
|
( |
) |
$ |
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$ |
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( |
) |
$ |
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See Accompanying Notes to these Condensed Consolidated Financial Statements
6
Table of Contents
PLUS THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
|
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For the Three Months Ended March 31, |
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2026 |
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2025 |
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Cash flows from operating activities: |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Stock-based compensation expense |
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Noncash financing expenses |
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— |
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Noncash interest expense |
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— |
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Change in fair value of derivative instruments |
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— |
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Accretion of discount on short-term investments |
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( |
) |
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— |
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Operating lease right-of-use asset amortization |
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Gain on sale of assets |
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— |
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( |
) |
Increases (decreases) in cash caused by changes in operating assets and liabilities: |
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Grant receivable |
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( |
) |
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Other assets |
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Accounts payable and accrued expenses |
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( |
) |
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Change in operating lease liabilities |
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( |
) |
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( |
) |
Other liabilities |
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( |
) |
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— |
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Deferred grant liability |
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— |
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|
Net cash used in operating activities |
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
||
Cash flows from investing activities: |
|
|
|
|
|
|
||
Purchases of property and equipment |
|
|
( |
) |
|
|
( |
) |
Proceeds from sale of property and equipment |
|
|
— |
|
|
|
|
|
Purchase of short-term investments |
|
|
( |
) |
|
|
— |
|
Redemption of short-term investments |
|
|
|
|
|
|
||
Net cash (used in) provided by investing activities |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
|
||
Cash flows from financing activities: |
|
|
|
|
|
|
||
Proceeds from credit facility |
|
|
|
|
|
— |
|
|
Repayment of credit facility |
|
|
( |
) |
|
|
( |
) |
Proceeds from issuance of notes payable and warrants |
|
|
— |
|
|
|
|
|
Repayment of notes payable |
|
|
— |
|
|
|
( |
) |
Proceeds from sale of common stock, pre-funded warrants and warrants |
|
|
— |
|
|
|
|
|
Proceeds from exercise of warrants |
|
|
— |
|
|
|
|
|
Proceeds from underwritten public offering |
|
|
|
|
|
— |
|
|
Payment to investors pursuant to Letter Agreement |
|
|
( |
) |
|
|
— |
|
Offering costs for sale of common stock |
|
|
( |
) |
|
|
— |
|
Net cash provided by financing activities |
|
|
|
|
|
|
||
Net change in cash and cash equivalents |
|
|
( |
) |
|
|
|
|
Cash, restricted cash and cash equivalents at beginning of period |
|
|
|
|
|
|
||
Cash, restricted cash and cash equivalents at end of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental disclosure of cash flows information: |
|
|
|
|
|
|
||
Cash paid during period for: |
|
|
|
|
|
|
||
Interest |
|
$ |
— |
|
|
$ |
|
|
Supplemental schedule of non-cash investing and financing activities: |
|
|
|
|
|
|
||
Exchange of warrants for notes payable |
|
$ |
— |
|
|
$ |
|
|
Redemption of notes by issuance of common stock, pre-funded warrants and warrants |
|
$ |
— |
|
|
$ |
|
|
Unpaid offering cost |
|
$ |
— |
|
|
$ |
|
|
See Accompanying Notes to these Condensed Consolidated Financial Statements
7
Table of Contents
PLUS THERAPEUTICS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2026
(UNAUDITED)
1. Organization and Basis of Presentation
Description of Business
Plus Therapeutics, Inc. (the “Company”) is a U.S. healthcare company developing and commercializing precision diagnostics and targeted radiopharmaceuticals for central nervous system (“CNS”) cancers. CNSide Diagnostics, LLC (“CNSide Diagnostics”) is the Company's wholly owned subsidiary that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. In radiopharmaceuticals, the Company's lead candidate, rhenium (186Re) obisbemeda, is designed specifically for CNS cancers including recurrent glioblastoma (“GBM”), leptomeningeal metastases (“LM”), and pediatric brain cancers (“PBC”) by direct localized delivery utilizing approved standard-of-care tissue access such as with convection-enhanced delivery (“CED”) and intraventricular brain (Ommaya reservoir) catheters. The Company's acquired radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (“188RNL-BAM”) is designed to treat many solid organ cancers including primary and secondary liver cancers by intra-arterial injection.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements for the three months ended March 31, 2026 and 2025 have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by US GAAP for annual financial statements. The condensed consolidated balance sheet at December 31, 2025 has been derived from the audited consolidated financial statements at December 31, 2025, but does not include all of the information and footnotes required by US GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of the Company have been included. Operating results for the three months ended March 31, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026.
Amendments to Certificate of Incorporation and Reverse Stock Split
At the Annual Meeting of Stockholders of the Company held on August 7, 2025 (the “Annual Meeting”), the stockholders of the Company approved an amendment to the Company’s Amended and Restated Certificate of Incorporation (the “Charter”) to implement a reverse stock split of the Company’s common stock, par value $
As a result of the Reverse Stock Split, every twenty-five (25) shares of the Company’s issued and outstanding common stock, par value $0.001, were converted into one (1) share of common stock, par value $
Proportional and retroactive adjustments for the reverse stock split were made to the Company’s outstanding shares, stock-based awards, warrants and equity incentive plans for all periods presented in the condensed consolidated financial statements in this Form 10-Q. The Company’s financial statements, and all references thereto have been retroactively adjusted to reflect the reverse split unless specifically stated otherwise.
2. Summary of Significant Accounting Policies
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in its Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC and have not materially changed during the three months ended March 31, 2026 except for the Diagnostic Test Revenue Recognition as outlined below. The Company believes that the disclosures provided here are adequate to make the information presented not misleading when these unaudited condensed consolidated financial statements are read in conjunction
8
Table of Contents
with the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 12, 2026.
Use of Estimates
Diagnostic Test Revenue Recognition
The Company recognizes diagnostic revenue in accordance with ASC 606 upon delivery of diagnostic services pursuant to a contract. Contracts for diagnostic testing services generally contain a single performance obligation which represents the delivery of a completed test report to the ordering healthcare provider. The transaction price is the amount the Company expects to be entitled to after estimated contractual adjustments and implicit price concessions for patient-responsibility amounts. These estimates reduce gross charges to estimated net realizable value and are recorded as a reduction of revenue (not as bad debt expense) at the time of revenue recognition. The Company recognizes revenue at a point in time when the test report is delivered as this represents the transfer of control of the promised service. The Company estimates variable considerations, including contractual payer adjustments, and applies the constraint to ensure revenue is recognized only to the extent that it is probable that a significant reversal will not occur. For payer-based arrangements, the Company estimates transaction price using historical reimbursement rates and experience, known payer mix, denial trends, coverage determinations, and contracted reimbursement rates. Where payer-specific history is limited (including for newly covered payers or new coding/coverage pathways), management incorporates peer and industry information, and applies constraint judgments. Changes in estimates are recognized in the period of change and are adjusted for payer mix, coverage decisions, and denial trends.
Amounts that are not expected to be reimbursed are treated as implicit price concessions and not recorded as revenue. If no payor agreements are in place, revenue is recognized when cash is received or when collectability becomes probable.
During the three months ended March 31, 2026, the Company started commercial billing for diagnostic revenue. However, the estimated net revenue amount was immaterial for recognition in the statement of operations.
Grant Revenue Recognition
In applying the provisions of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company has determined that government grants are out of the scope of ASC 606 because the funding entities do not meet the definition of a “customer,” as defined by ASC 606, as there is not considered to be a transfer of control of goods or services. With respect to the grant, the Company determines if it is a collaboration arrangement in accordance with ASC Topic 808, Collaborative Arrangements (“ASC 808”). For grants outside the scope of ASC 808, the Company applies International Accounting Standards No. 20, Accounting for Government Grants and Disclosure of Government Assistance, by analogy, and revenue is recognized when the Company incurs expenses related to the grant for the amount the Company is entitled to under the provisions of the contract.
The Company also considers the guidance in ASC Topic 730, Research and Development (“ASC 730”), which requires an assessment, at the inception of the grant, of whether the agreement is a liability. If the Company is obligated to repay funds received regardless of the outcome of the related research and development activities, then the Company is required to estimate and recognize that liability. Alternatively, if the Company is not required to repay the funds, then payments received are recorded as revenue or contra-expense as the expenses are incurred.
Deferred grant liability represents grant funds received or receivable for which the allowable expenses have not yet been incurred as of the balance sheet date. Grant receivable represents grant funds not yet received for which the allowable expenses have been incurred as of the balance sheet date.
Warrants
Warrants are accounted for as either derivative liabilities or as equity instruments depending on the specific terms of the agreement in accordance with applicable accounting guidance provided in ASC Topic 815 - Derivatives and Hedging. Equity-classified instruments are recorded in additional paid-in capital at issuance and are not subject to remeasurement. Liability-classified warrants are recorded at fair value at each reporting period with any change in fair value recognized as a component of change in fair value of warrants in the consolidated statements of operations. The Company periodically evaluates changes in facts and circumstances that could impact the classification of warrants.
Available-for-Sale Securities
The Company’s available-for-sale securities generally consist of U.S. government and agency securities and bonds. Securities with maturities from the date of purchase of less than three months are included in cash equivalents. The Company classifies its marketable securities as available-for-sale and records such assets at estimated fair value in the condensed consolidated balance sheets, with unrealized gains and losses, if any, reported as a component of other comprehensive income (loss) and as a separate component of stockholders’ equity. Realized gains and losses are calculated on the specific identification method and recorded as
9
Table of Contents
interest income (expense). At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the decline in fair value below amortized cost is a result of credit losses or other factors, whether the Company expects to recover the amortized cost of the security, the Company’s intent to sell and if it is more likely than not that the Company will be required to sell the securities before the recovery of amortized cost. The Company records changes in allowance for expected credit loss in other income (expense). There has been no allowance for expected credit losses recorded during any of the periods presented.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03 Income Statement (Topic 220): Reporting Comprehensive Income - Expense Disaggregation Disclosures, which requires an entity to disclose on an annual and interim basis, disaggregated information about specific income statement expense categories. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes effective for the annual period starting on January 1, 2027 and interim periods starting on January 1, 2028. The Company is in the process of analyzing the impact that the adoption of ASU 2024-03 will have on its disclosures.
3. Liquidity and Going Concern
The Company has had, and will continue to have, an ongoing need to raise additional cash from outside sources to fund its future clinical development programs, launch the CNSide Test, and fund other operations. There can be no assurance that the Company will be able to continue to raise additional capital in the future. The Company’s inability to raise additional cash would have a material and adverse impact on its operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
As disclosed in more detail in Note 12 Stockholders' Equity, the Company has entered into various financing agreements to raise capital. The Company continues to seek additional capital from financing alternatives and other sources in order to ensure adequate funding is available to allow the Company to continue research and development activities. If sufficient capital is not raised, the Company will at a minimum need to significantly reduce or curtail its research and development and other operations, and this would have a material adverse impact on its operations.
The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.
Nasdaq Listing Compliance
Minimum Stockholders’ Equity Requirement
The Company is currently in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”). The Company is subject to monitoring through August 22, 2026 with respect to the Minimum Stockholders’ Equity Requirement. If, within such period, the Listing Qualifications staff of Nasdaq (the “Staff”) determines that the Company no longer satisfies the Minimum Stockholders’ Equity Requirement (and it is not then in compliance with one of the alternative standards under Nasdaq Listing Rule 5550(b)), it will not be permitted to provide the Staff with a plan of compliance and the Staff is not permitted to grant additional time to regain compliance with the Minimum Stockholders’ Equity Requirement nor will it be afforded an applicable cure or compliance period. Instead, the Staff will issue a delist determination letter, and the Company will have an opportunity to request a new hearing before the Nasdaq Hearings Panel, which request would stay any further action by the Staff pending the ultimate outcome of the hearing.
Minimum Bid Requirement
On April 20, 2026, the Company received written notice (the “Notification Letter”) from The Nasdaq Stock Market LLC notifying the Company that it had regained compliance with the Minimum Bid Requirement. The Notification Letter was sent following the implementation of the Reverse Stock Split, which became effective on April 2, 2026. Additional information regarding the Reverse Split can be found in the Company’s Current Report on Form 8-K filed on April 2, 2026.
4. Fair Value Measurements
Fair value measurements are market-based measurements, not entity-specific measurements. Therefore, fair value measurements are determined based on the assumptions that market participants would use in pricing the asset or liability. The Company follows a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below:
10
Table of Contents
Assets recorded at fair value
The Company has investments in money market accounts which are included in cash and cash equivalents on the condensed consolidated balance sheets. Certain treasury bills are also considered cash equivalents if their maturities are three months or less at the time of purchase. Fair value inputs for these investments are considered Level 1 measurements within the fair value hierarchy since money market account and treasury bill fair values are known and observable through daily published floating net asset values.
The Company did not adjust or override any fair value measurements as of March 31, 2026 or December 31, 2025. The Company does not have any investments classified as Level 3 and no investment transferred between classification levels during the three months ended March 31, 2026.
The following table summarizes the Company’s fair value hierarchy for its financial assets measured at fair value on a recurring basis as of March 31, 2026 and December 31, 2025, respectively (in thousands):
|
Fair Value Measurements Using |
|
||||||||||
March 31, 2026 |
Fair Value |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
||||
Money market |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
Total cash equivalents |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
||||
Investments |
|
|
|
|
|
|
|
|
||||
Treasury bills |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
Government bonds |
|
|
|
|
|
— |
|
|
— |
|
||
Total Investments |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
||||
|
Fair Value Measurements Using |
|
||||||||||
December 31, 2025 |
Fair Value |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
||||
Money market |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
Treasury bills |
|
|
|
|
|
— |
|
|
— |
|
||
Total cash equivalents |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
|
|
|
|
|
|
|
|
|
||||
Investments |
|
|
|
|
|
|
|
|
||||
Treasury bills |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
Government agency bonds |
|
|
|
|
|
— |
|
|
— |
|
||
Total Investments |
$ |
|
$ |
|
$ |
— |
|
$ |
— |
|
||
Liabilities recorded at fair value
Convertible Notes
As detailed in Note 12 Stockholders' Equity, the Company elected to account for convertible notes (consisting of funding notes and exchange notes) issued on February 13, 2025 at fair value as of the issuance date and immediately before their settlement date of March 4, 2025. The convertible notes were valued using the binomial lattice model with the following key level 3 inputs:
|
|
At issuance |
|
|
At settlement |
|
||
Interest rate |
|
|
|
|
% |
|||
Remaining term (years) |
|
|
|
|
|
|
||
Volatility |
|
|
% |
|
|
% |
||
Fair value of common stock |
|
$ |
|
|
$ |
|
||
The following table provides a roll forward of the fair value of the convertible notes during the three months ended March 31, 2025 (in thousands):
11
Table of Contents
|
|
Funding Notes |
|
|
Exchange Notes |
|
||
Beginning balance as of January 1, 2025 |
|
$ |
|
|
$ |
|
||
Issuance |
|
|
|
|
|
|
||
Change in fair value |
|
|
( |
) |
|
|
( |
) |
Settlement |
|
|
( |
) |
|
|
( |
) |
Ending balance as of March 31, 2025 |
|
$ |
|
|
$ |
|
||
Warrants
As detailed in Note 12 Stockholders' Equity,
|
|
At issuance |
|
|
At modification and extinguishment |
|
||
Interest rate |
|
|
% |
|
|
% |
||
Remaining term (years) |
|
|
|
|
|
|
||
Volatility |
|
|
% |
|
|
% |
||
|
|
|
|
|
|
|
||
The March 2025 Series B Warrants were valued immediately prior to exercise, using the Monte Carlo simulation with the following inputs for the exercises that occurred before the modification on June 17, 2025:
|
|
At exercise |
Interest rate |
|
|
Remaining term (years) |
|
|
Volatility |
|
In addition, the February 2025 Warrants issued in connection with the Funding Notes were required to be classified as liabilities and recorded at fair value. The Company estimated the fair value of the February 2025 Warrants using the Black Scholes model at issuance as of February 13, 2025 and as of their redemption date of March 4, 2025, using the following level 3 inputs:
|
|
At issuance |
|
|
At settlement |
|
||
Interest rate |
|
|
% |
|
|
% |
||
Remaining term (years) |
|
|
|
|
|
|
||
Volatility |
|
|
% |
|
|
% |
||
Fair value of common stock |
|
$ |
|
|
$ |
|
||
The following table provides a roll forward of the fair value of liability classified common stock warrants during the three months ended March 31, 2025 (in thousands):
|
|
February 2025 Warrants |
|
|
March 2025 Series A Warrants |
|
|
March 2025 Series B Warrants |
|
|
Total |
|
||||
Beginning balance as of January 1, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Issuance |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in fair value |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Settlement |
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
||
Ending balance as of March 31, 2025 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Investor Liability Pursuant to Letter Agreement and Support Letters
The repayment obligation owed to certain March 2025 Private Placement Purchasers pursuant to the amended Letter Agreement and Support Letters was accounted for at fair value as a financial liability in accordance with ASC 480. The Company measured the fair value of the repayment obligation using Level 3 inputs. As of December 31, 2025, the Company had a liability of approximately $
12
Table of Contents
Nonfinancial Assets and Liabilities
The Company applies fair value techniques on a non-recurring basis, if and when necessary, associated with: (1) valuing potential impairment losses related to goodwill and intangible assets which are accounted for pursuant to the authoritative guidance for intangibles—goodwill and other; and (2) valuing potential impairment losses related to long-lived assets which are accounted for pursuant to the authoritative guidance for property, plant and equipment. There was
5. Short-Term Investments
The Company classified short-term investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to facilitate the execution of management strategies. During the three months ended March 31, 2026 and 2025, the unrealized gain on the Company's available-for-sale securities was immaterial, and not presented separately in the condensed consolidated statements of operations.
The Company classified all investments with maturities longer than three months from the date of purchase as short-term investments in the condensed consolidated balance sheets, reflecting its intent and ability to use these assets to meet the liquidity requirements of current operations.
|
Amortized Cost |
|
Estimated Fair Value |
|
||
Due in one year or less |
$ |
|
$ |
|
||
Due after one year through five years |
|
|
|
|
||
Due after five years |
|
|
|
|
||
Total Investments |
$ |
|
$ |
|
||
6. Loss per Share
Basic per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period increased to include, if dilutive, the number of additional common shares that would have been outstanding as calculated using the treasury stock or if-converted method, as applicable. Pre-funded warrants are included in the weighted average shares outstanding calculation (as of the beginning of the period or the date of the grant, whichever was earlier) for basic and dilutive earnings per share given their nominal exercise price.
The following table provides a summary of instruments where underlying shares issuable upon exercise or conversion were excluded from the diluted loss per share calculation for the periods presented because their effect would be anti-dilutive. Additionally, the shares underlying the February 2025 Warrants, Funding Notes and Exchange Notes, each outstanding during the three months ended March 31, 2025, were excluded from diluted loss per share as their effect would be anti-dilutive.
|
As of March 31, |
|
||||||
|
2026 |
|
|
2025 |
|
|||
Outstanding stock options |
|
|
|
|
|
|
||
Outstanding restricted stock units |
|
|
|
|
|
- |
|
|
Preferred stock |
|
|
|
|
|
|
||
Outstanding warrants (Note 12) |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
7
CPRIT Grant
On September 19, 2022, the Company entered into that certain Cancer Research Grant Contract (the “CPRIT Contract”), effective as of
The CPRIT Contract will terminate on August 28, 2026, unless terminated earlier by (a) the mutual written consent of all parties to the CPRIT Contract, (b) CPRIT for an event of default by the Company, (c) CPRIT, if the funds allocated to the CPRIT Grant
13
Table of Contents
become legally unavailable during the term of the CPRIT Contract and CPRIT is unable to obtain additional funds for such purposes, and (d) the Company for convenience. CPRIT may require the Company to repay some or all of the disbursed CPRIT Grant proceeds (with interest not to exceed
The Company retains ownership over any intellectual property developed under the CPRIT Contract (each, a “Project Result”). With respect to non-commercial use of any Project Result, the Company granted to CPRIT a nonexclusive, irrevocable, royalty-free, perpetual, worldwide license with right to sublicense any necessary additional intellectual property rights to exploit all Project Results by CPRIT, other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education located in Texas, for education, research and other non-commercial purposes.
The Company recognized $
Department of Defense Award
Effective September 1, 2024, the Company entered into an agreement with the Department of Defense office of the Congressionally Directed Medical Research Programs to receive a $
8. Commitments and Contingencies
Leases
On October 16, 2025, the Company entered into a lease (the “Houston Lease”) with LG 1 Property Owner LP, pursuant to which the Company agreed to lease approximately
The Company also leases certain office space in Charlottesville, Virginia (the “Charlottesville Lease”).
Manufacturing Agreement with SpectronRx
On November 5, 2024, the Company entered into a manufacturing services agreement with SpectronRx for drug product development and manufacturing, which includes an initial commitment fee of $
Other commitments and contingencies
The Company has entered into agreements with various research organizations for preclinical and clinical development studies, which have provisions for cancellation. Under the terms of these agreements, the vendors provide a variety of services including conducting research, recruiting and enrolling patients, monitoring studies and data analysis. Payments under these agreements typically include fees for services and reimbursement of expenses. The timing of payments due under these agreements is estimated based on study progress. As of March 31, 2026, the Company did
The Company has entered into service and subscription-based agreements, which are recorded in accounts payable and accrued expenses, with an offsetting amount included in deferred costs within other current assets.
14
Table of Contents
Legal proceedings
The Company is subject to various claims and contingencies related to legal proceedings. Due to their nature, such legal proceedings involve inherent uncertainties including, but not limited to, court rulings, negotiations between affected parties and governmental actions. Management assesses the probability of loss for such contingencies and accrues a liability and/or discloses the relevant circumstances, as appropriate.
9. Composition of Certain Financial Statement Captions
As of March 31, 2026 and December 31, 2025, other current assets were comprised of the following (in thousands):
|
|
|
|
|||||
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Prepaid services |
|
$ |
|
|
$ |
|
||
Deferred costs |
|
|
|
|
|
|
||
Prepaid insurance |
|
|
|
|
|
|
||
Total other current assets |
|
$ |
|
|
$ |
|
||
10. Line of Credit Facility
The Company has a margin loan facility under a line of credit (the “Pershing Credit Facility”) with Pershing LLC (“Pershing”), an affiliate of The Bank of New York Mellon Corporation. The available credit line limit under the Pershing Credit Facility fluctuates based on the Company’s request for extensions from time to time, subject to the value of the collateralized marketable securities the Company holds with Pershing, provided that the amount available to draw under the Pershing Credit Facility cannot exceed
Borrowings under the Pershing Credit Facility bear interest at the target interest rate set by the Federal Open Market Committee, subject to a floor of
As of March 31, 2026 and December 31, 2025, the outstanding balances on the line of credit facility with Pershing were $
11. License Agreements
UT Health Science Center at San Antonio (“UTHSCSA”) License Agreement
On December 31, 2021, the Company entered into a Patent and Know-How License Agreement (the “UTHSCSA License Agreement”) with The University of Texas Health Science Center at San Antonio (“UTHSCSA”), pursuant to which UTHSCSA granted the Company an irrevocable, perpetual, exclusive, fully paid-up license, with the right to sublicense and to make, develop, commercialize and otherwise exploit certain patents, know-how and technology related to the development of biodegradable alginate microspheres (“BAM”) containing nanoliposomes loaded with imaging and/or therapeutic payloads.
NanoTx License Agreement
On March 29, 2020, the Company and NanoTx, Corp. (“NanoTx”) entered into a Patent and Know-How License Agreement, pursuant to which NanoTx granted the Company an irrevocable, perpetual, exclusive, fully paid-up license, with the right to sublicense and to make, develop, commercialize and otherwise exploit certain patents, know-how and technology related to the development of radiolabeled nanoliposomes.
The transaction terms included an upfront payment of $
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12. Stockholders’ Equity
Reverse Stock Split
Preferred Stock
The Company has authorized
Series B and C Preferred Stock
As of March 31, 2026, there were
Common Stock
February 2025 SPEA Agreements
On February 13, 2025 (the “February 2025 Closing Date”), the Company entered into a Securities Purchase and Exchange Agreement (the “February 2025 SPEA”) with certain existing accredited investors (the “February 2025 Purchasers”). Pursuant to the February 2025 SPEA, on the February 2025 Closing Date the Company issued secured convertible promissory notes (the “Funding Notes”) in the aggregate principal amount of $
The Funding Notes, accrued interest and February 2025 warrants were repurchased by the Company subsequent to consummation of the March 2025 Private Placement for proceeds of $
Security Interest
The obligations of the Company under the February 2025 SPEA, Funding Notes and Exchange Notes (as defined below) were secured by a pledge of substantially all of the assets of the Company pursuant to a security agreement, dated as of the February 2025 Closing Date, among the Company, CNSide Diagnostics, LLC (a subsidiary of the Company, “CNSide Diagnostics”), and Iroquois Master Fund Ltd., as collateral agent for the February 2025 Purchasers (the “Security Agreement”), subject to certain exceptions. The Security Agreement contained certain customary affirmative and negative covenants, including limitations on the Company’s and CNSide Diagnostics’ ability to dispose of assets, subject to customary exceptions. The repayment of the Company’s obligations under the February 2025 SPEA and Notes were guaranteed pursuant to a subsidiary guarantee, dated as of the February 2025 Closing Date (the “Subsidiary Guarantee”), by and among CNSide Diagnostics and the February 2025 Purchasers. The Security Agreement and the Subsidiary Guarantee were subsequently terminated after the closing of the private placement pursuant to the March 2025 SPA (as defined below).
Exchange Notes
As disclosed below, the Company entered into the May 2024 Purchase Agreement (defined below), with the May 2024 Purchasers for the private placement of securities, including the May 2024 Series A Warrants to purchase an aggregate of up to
Both the Funding Notes and the Exchange Notes contained embedded conversion features that were required to be bifurcated and accounted for as derivative liabilities. The Company evaluated authoritative guidance for accounting for convertible debt instruments and elected to account for the Funding Notes and Exchange Notes at fair value. Consequently, the Company recorded
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the Funding Notes and Exchange Notes in their entirety at fair value at issuance and immediately before settlement, with changes in fair value recorded as change in fair value of derivative instruments in the condensed consolidated statements of operations between the issuance date and the settlement date.
The Company entered into the transaction due to immediate funding requirements. Under authoritative guidance, if the fair value of a warrant liability exceeds the proceeds received in an arm’s length transaction with no rights or privileges that require separate accounting recognition as an asset identified, then the warrant liability is recorded at fair value with the excess of fair value over proceeds recognized as a loss in earnings. The Exchange Notes, Funding Notes and associated warrants were recorded at fair value on the issuance date at $
Changes in the fair value of Exchange Notes, Funding Notes and February 2025 Warrants between issuance date and settlement date, in the amount of a gain of $
March 2025 Private Placement
On March 4, 2025, the Company entered into a securities purchase agreement (the “March 2025 SPA”) with accredited investors, including certain existing stockholders of the Company (collectively, the “March 2025 Private Placement Purchasers”) for a private placement of securities (the “March 2025 Private Placement”). The March 2025 SPA, provided for the sale and issuance by the Company of an aggregate of
The initial exercise price of each March 2025 Series A Warrant issued in the March 2025 Private Placement was $
The initial exercise price of each March 2025 Series B Warrant issued in the March 2025 Private Placement was $
The March 2025 Pre-Funded Warrants will be exercisable from the date of issuance until exercised in full. The March 2025 Pre-Funded Warrants, March 2025 Series A Warrants and March 2025 Series B Warrants may not be exercised to the extent that immediately following such exercise, the holder would beneficially own greater than
In connection with the March 2025 Private Placement, the Company issued
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The Company evaluated the terms of the February 2025 Warrants, March 2025 Series A Warrants and March 2025 Series B Warrants under authoritative guidance and concluded that each of the instruments should be accounted for as a liability instrument at fair value at issuance and each subsequent balance sheet date until settlement, with changes in the fair value recorded in the condensed consolidated statement of operations. The March 2025 Pre-Funded Warrants met the criteria to be recorded as equity in the Company's condensed consolidated balance sheet.
The March 2025 Private Placement closed on March 7, 2025 (the “March 2025 Closing Date”). The aggregate gross proceeds at the March 2025 Closing Date totaled approximately $
On May 2, 2025, the Company’s stockholders approved, among other things, the March 2025 Series A Warrants and March 2025 Series B Warrants, and an amendment to the Company’s Certificate of Incorporation, as amended, to increase the authorized share capital of the Company to an amount sufficient to cover the shares of common stock issuable upon the exercise of the March 2025 Series A Warrants and March 2025 Series B Warrants. As part of the March 2025 Series A Warrants and March 2025 Series B Warrants agreement, the exercise price of the March 2025 Series A Warrants and March 2025 Series B Warrants were both reset on May 19, 2025 to $
Letter Agreement
On June 17, 2025, the Company and the March 2025 Private Placement Purchasers entered into a letter agreement (the “Letter Agreement”) with each of the March 2025 Private Placement Purchasers in an effort to, among other items, minimize the dilutive impact of the March 2025 Private Placement. The Letter Agreement extinguished the March 2025 Series A Warrants, modified the March 2025 Series B Warrants, and provided for the return and cancellation of Private Placement Shares and Pre-Funded Warrants, as further discussed in the following paragraphs.
As part of the same transaction, the March 2025 Series B Warrants were amended (the “Amended March 2025 Series B Warrants”), to (a) reduce the overall number of March 2025 Series B Warrant Shares issuable upon exercise of the Series B Warrants to an aggregate of up to
Lastly, in conjunction with the Letter Agreement, each of the March 2025 Private Placement Purchasers agreed to return an aggregate of
Support Letters
On July 11, 2025, the Company and certain March 2025 Private Placement Purchasers party to the Letter Agreement entered into that certain letter of support (the “Support Letters”) to modify certain portions of the Letter Agreement as between the Company and each of such March 2025 Private Placement Purchasers. Pursuant to the Support Letters, in the event that the Company reasonably believes that, within the
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On October 28, 2025, the Company entered into an amendment to the Letter Agreement and the Support Letters with certain March 2025 Private Placement Purchasers (the “Amendment Agreement”), pursuant to which (a) the Support Letters were terminated other than with respect to the participation rights granted therein, and (b) the repayment mechanism under the Letter Agreement was modified. As modified, the Company was required to retain sufficient funds in an interest bearing account to cover such repayment obligations and make such repayments upon request by any March 2025 Private Placement Purchaser who executed the Amendment Agreement until each such purchaser had received cash either from the Company or from reselling securities acquired in the March 2025 Private Placement in an amount equal to
During the three months ended March 31, 2026, the Company paid the March 2025 Private Placement Purchasers $
First Amendment to the February 2025 SPEA
In connection with entering into the March 2025 SPA, the Company entered into that certain First Amendment to the February 2025 SPEA (the “First Amendment”). The February 2025 SPEA included certain limitations and restrictions on the Company’s ability to issue securities and provided the investors with participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the “New Financing Restrictions”). Pursuant to the First Amendment, subject to consummation of the March 2025 Private Placement, the Company agreed to repurchase from the Investors $
As of the quarter ended March 31, 2026, all outstanding warrants from the March 2025 Private Placement have been exercised, and all March 2025 Private Placement Purchasers have received repayments or resold their securities.
Lincoln Park Purchase Agreement
On June 17, 2025, the Company entered into a purchase agreement (the “Lincoln Park Purchase Agreement”) and a registration rights agreement (the “Registration Rights Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park committed to purchase up to $
Under the Lincoln Park Purchase Agreement, on any business day selected by the Company over the
The Company also has the right to direct Lincoln Park, on any business day on which the Company has properly submitted a Regular Purchase notice for the maximum amount the Company is then permitted to sell to Lincoln Park in such Regular Purchase, to purchase an additional amount of the common stock (an “Accelerated Purchase”) of additional shares based on criteria established in the Lincoln Park Purchase Agreement. The purchase price per share for each such Accelerated Purchase will be
In addition to the Regular Purchase and Accelerated Purchase, the Company can sell to Lincoln Park an additional amount of common stock (an "Additional Accelerated Purchases"), which can be initiated multiple times on the same Additional Accelerated Purchase date. The purchase price per share for each such Additional Accelerated Purchase will be
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Agreement, and (ii) the closing sale price of the Company’s common stock on The Nasdaq Capital Market on the same Additional Accelerated Purchase date.
The sales of shares of common stock to Lincoln Park through a Regular Purchase, an Accelerated Purchase and an Additional Accelerated Purchases, depend upon a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the Lincoln Park Purchase Agreement to the Company depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park.
January 2026 Public Offering
On January 13, 2026, the Company completed an underwritten public offering pursuant to which the Company (a) sold an aggregate of (i)
Outstanding Warrants
As of March 31, 2026, the Company had the following warrants outstanding:
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March 31, 2026 |
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May 2024 Series A Warrants |
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May 2024 Series B Warrants |
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January 2026 Warrants |
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Total |
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13. Stock-Based Compensation
Under the Company’s 2015 New Employee Incentive Plan (the “2015 Plan”), awards may only be granted to employees who were not previously an employee or director of the Company, or following a bona fide period of non-employment, as a material inducement to entering into employment with the Company. As of March 31, 2026, there were
The Company’s 2020 Stock Incentive Plan (the “2020 Plan”), which replaced the Company’s 2014 Equity Incentive Plan, provides for the award or sale of shares of common stock (including restricted stock), the award of stock units and stock appreciation rights, and the grant of both incentive stock options to purchase common stock to directors, officers, employees and consultants of the Company. The 2020 Plan, provides for the issuance of up to
Generally, options issued under the 2020 Plan are subject to a
A summary of stock option activity for the three months ended March 31, 2026 is as follows:
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Options |
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Weighted |
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Weighted |
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Aggregate |
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Outstanding as of December 31, 2025 |
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$ |
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$ |
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Granted |
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$ |
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— |
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$ |
— |
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Cancelled/forfeited/expired |
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( |
) |
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$ |
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— |
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$ |
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Outstanding as of March 31, 2026 |
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$ |
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$ |
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Vested and expected to vest at March 31, 2026 |
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$ |
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$ |
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Exercisable at March 31, 2026 |
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$ |
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$ |
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As of March 31, 2026, the total compensation cost related to non-vested stock options not yet recognized for all the Company’s plans is approximately $
Generally, restricted stock units represent the right to receive a certain number of shares of common stock subject to certain vesting conditions and other restrictions. The fair value of restricted stock units is determined by the closing market price on the grant date.
A summary of restricted stock unit activity for the three months ended March 31, 2026 is as follows:
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Shares |
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Weighted |
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Unvested as of December 31, 2025 |
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|
$ |
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||
Granted |
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|
$ |
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||
Vested |
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|
( |
) |
|
$ |
|
|
Cancelled/forfeited |
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|
( |
) |
|
$ |
|
|
Unvested as of March 31, 2026 |
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|
|
|
$ |
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||
Restricted stock units granted during the three months ended March 31, 2026 generally vest over a 36-month period upon satisfaction of service conditions. As of March 31, 2026, the total compensation cost related to non-vested restricted stock units not yet recognized for all the Company’s plans is approximately $
14. Segment Information
The Company operates under
In addition to the significant expense categories included within the consolidated statements of operations, the below disaggregated amounts comprise significant research and development and general and administrative expenses. These expenses consist of (1) clinical, manufacturing and research contracts for research and development programs, (2) personnel-related expenses, including salaries, benefits and stock-based compensation, (3) professional fees, including third-party costs for goods and services such as lab supplies and contract research, and legal and other professional expenses, and (4) facility and other overhead expenses, including depreciation, occupancy, travel, insurance and other costs. Depreciation and amortization expense is consistent with those presented in the condensed consolidated statements of cash flows.
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For the Three Months Ended March 31, |
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(in thousands) |
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2026 |
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2025 |
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Research and development |
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Clinical, development and licensing expenses |
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$ |
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$ |
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Personnel related expenses |
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Professional fees |
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Facility and other overhead expenses |
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Total research and development |
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General and administrative |
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Personnel related expenses |
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Professional fees |
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Facility and other overhead expenses |
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Total general and administrative |
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$ |
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$ |
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15. Subsequent Events
On April 20, 2026, the Company received the Notification Letter from The Nasdaq Stock Market LLC notifying the Company that it had regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued
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listing on The Nasdaq Capital Market (“Nasdaq”). The Notification Letter was sent following the implementation of the Reverse Stock Split, which became effective on April 2, 2026.
On May 12, 2026, the Company filed a Certificate of Correction (the “Certificate of Correction”) to a Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company (the “Certificate of Amendment”) that was previously filed on April 1, 2026. The Certificate of Amendment erroneously stated the number of authorized shares of common stock, par value $
As corrected by the Certificate of Correction, the total number of authorized shares of Common Stock is two billion (
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited financial information and the notes thereto included herein, as well as the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our audited consolidated financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed on March 12, 2026. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the caption “Cautionary Note Regarding Forward-Looking Statements” in this Quarterly Report, as well as under “Part I – Item 1A - Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, in other subsequent filings with the Securities and Exchange Commission, and elsewhere in this Quarterly Report. These statements, like all statements in this Quarterly Report, speak only as of the date of this Quarterly Report (unless another date is indicated), and the Company undertakes no obligation to update or revise these statements in light of future developments.
Our Management’s Discussion and Analysis of Financial Condition and Results of Operations includes the following sections:
Overview
Plus Therapeutics is a U.S. healthcare company developing and commercializing precision diagnostics and targeted radiopharmaceuticals for central nervous system (“CNS”) cancers. CNSide Diagnostics, LLC (“CNSide Diagnostics”) is our wholly owned subsidiary that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. In radiopharmaceuticals, our lead candidate, rhenium (186Re) obisbemeda, is designed specifically for CNS cancers including recurrent glioblastoma (“GBM”), leptomeningeal metastases (“LM”), and pediatric brain cancers (“PBC”) by direct localized delivery utilizing approved standard-of-care tissue access such as with convection-enhanced delivery (“CED”) and intraventricular brain (Ommaya reservoir) catheters. Our acquired radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (“188RNL-BAM”) is designed to treat many solid organ cancers including primary and secondary liver cancers by intra-arterial injection.
Traditional approaches to radiation therapy for cancer, such as external beam radiation, have many disadvantages including continuous treatment for four to six weeks (which is onerous for patients), that the radiation damages healthy cells and tissue, and that the amount of radiation delivered is very limited and, therefore, is frequently inadequate to fully destroy the cancer.
Our novel radioactive drug formulations, medical devices and therapeutic candidates have the potential to overcome these disadvantages as they are designed to deliver safe and effective doses of radiation at the tumors—potentially in a single treatment. To achieve this, we have developed innovative approaches to drug formulation, including encapsulating radionuclides such as rhenium isotopes with nanoliposomes and microspheres. Our formulations are intended to achieve elevated patient-absorbed radiation doses and extend retention times such that the clearance of the isotope occurs after significant and essentially complete radiation decay, which will contribute and provide less normal tissue/organ exposure and improved safety margins.
By minimizing radiation exposure to healthy tissues while simultaneously maximizing locoregional delivery and, thereby, efficacy, we hope to reduce the radiation toxicity for patients, improving their quality of life and life expectancy. Our radiotherapeutic platform, combined with advances in neurosurgery, nuclear medicine, interventional radiology, neuro-oncology, and radiation oncology, affords us the opportunity to target a broad variety of cancer types.
The CNSide Cerebrospinal Fluid Assay is currently being utilized in the ReSPECT-LM clinical trial funded by the Cancer Prevention and Research Institute of Texas (“CPRIT”). In connection with our business plan for developing the CNSide Platform, we formed CNSide Diagnostics and our board of directors appointed a board of managers for CNSide Diagnostics. We re-introduced the CNSide Cerebrospinal Fluid Tumor Cell Enumeration test (the “CNSide Test”), which is a laboratory developed test (“LDT”) in August 2025. The laboratory for the CNSide Test in Houston, Texas has received a certificate of accreditation from the Centers for Medicare & Medicaid Services (CMS) which deems the lab compliant with Clinical Laboratory Improvement Amendments (“CLIA”) regulations. Furthermore, CNSide Diagnostics has signed national agreements to provide the CNSide Test with four payers, including United Healthcare, Humana, Highmark, and Blue Shield of California, expanding patient access nationwide.
Our headquarters is located in Houston, Texas, in proximity to world-class cancer institutions and researchers.
Pipeline
Our most advanced investigational drug, rhenium (186Re) obisbemeda, is a patented radiotherapy potentially useful for patients with CNS and other cancers. Preclinical study data describing the use of rhenium (186Re) obisbemeda for several cancer targets have been published in peer-reviewed journals and reported at a variety of medical society peer-reviewed meetings. Besides GBM, LM and PBC, rhenium (186Re) obisbemeda has been reported to have potential applications for head and neck cancer, ovarian cancer, breast cancer and peritoneal metastases.
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The rhenium (186Re) obisbemeda technology was part of a licensed radiotherapeutic portfolio that we acquired from NanoTx, Corp. (“NanoTx”) on May 7, 2020. The licensed radiotherapeutic has been evaluated in preclinical studies for several cancer targets and we have an active $3.0 million award from U.S. National Institutes of Health/National Cancer Institute which is expected to provide financial support for the continued clinical development of rhenium (186Re) obisbemeda for recurrent GBM through the completion of a Phase 2 clinical trial, including enrollment of up to 55 patients.
Rhenium (186Re) obisbemeda versus External Beam Radiation Therapy for Recurrent GBM
Rhenium (186Re) obisbemeda is a novel injectable radiotherapy designed to deliver targeted, high dose radiation directly into GBM tumors in a safe, effective, and convenient manner that may ultimately prolong patient survival. Rhenium (186Re) obisbemeda is composed of the radionuclide Rhenium-186 and a nanoliposomal carrier, and is infused in a highly targeted, controlled fashion, directly into the tumor via precision brain mapping and CED catheters. Potential benefits of rhenium (186Re) obisbemeda compared to standard external beam radiotherapy or external beam radiation therapy (“EBRT”) include:
ReSPECT-GBM Trial for Recurrent GBM
GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient’s life. GBM routinely presents with headaches, seizures, vision changes and other significant neurological complications, with a significant compromise in quality of life. Despite the best available medical treatments, the disease remains incurable. Even after efforts to manage the presenting signs and symptoms and completely resect the initial brain tumor, some microscopic disease almost always remains, and tumor regrowth occurs within months. Complete surgical removal of GBM is usually not possible and GBM is often resistant or quickly develops resistance to most available current and investigational therapies. Today, the treatment of GBM remains a significant challenge and it has been nearly a decade since the FDA approved a new therapy for this disease, and these more recent approvals have not improved the overall survival (“OS”) for GBM patients over past decades, and a significant unmet medical need persists.
While EBRT has been shown to be safe and has temporary efficacy in many malignancies including GBM, typically at absorbed, fractionated radiation dose of ~30 Gray in GBM, this maximum possible administered dose is always limited by toxicity to the normal tissues surrounding the malignancy and because EBRT requires fractionation to manage toxicity and maximum EBRT limits are typically reached before long-term efficacy reached. Because of this limitation, EBRT cannot provide a cure or long-term control of GBM and GBM always recurs within months after EBRT. In contrast, locally delivered and targeted radiopharmaceuticals that precisely deliver radiation in the form of beta particles such as Iodine-131 for thyroid cancer, are known to be safe and effective and minimize exposure to normal cells and tissues especially with optimal administered dose and minimizing exposure to normal tissue. The locally delivered rhenium (186Re) obisbemeda is designed for and provides patient tolerability and safety. Though no rhenium (186Re) obisbemeda head-to-head trial with chemo, immune, EBRT or systemic radiopharmaceutical products have been conducted, patient tolerability and safety considerations have been reported as expected.
In September 2020, the FDA granted both orphan drug designation and Fast Track designations to rhenium (186Re) obisbemeda for the treatment of patients with GBM.
Rhenium (186Re) obisbemeda is under clinical investigation in a Phase 1/2 multicenter, sequential cohort, open-label, volume and dose escalation study (“ReSPECT-GBM”) of the safety, tolerability, and distribution of rhenium (186Re) obisbemeda given by CED catheters to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The trial is funded through Phase 2 in large part by a National Institute of Health/National Cancer Institute grant.
We completed Phase 1 of our ReSPECT-GBM Trial and are targeting full enrollment into Phase 2 by the end of 2026.
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ReSPECT-LM Clinical Trials for LM
LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. The incidence of LM is growing and occurs in approximately 5%, or more, of people with late-stage cancer, or 110,000 people in the U.S. each year. It is highly lethal with an average one-year survival of just 7%. All solid cancers, particularly breast, lung, GI, and melanoma, have the potential to spread to the leptomeninges.
The ReSPECT-LM Phase 1 clinical trial (ClinicalTrials.gov NCT05034497) was preceded with preclinical studies in which tolerance to doses of rhenium (186Re) obisbemeda as high as 1,075 Gy were shown in animal models with LM without significant observed toxicity. Furthermore, treatment led to a marked reduction in tumor burden in both C6 and MDA-231 LM models.
Upon receiving acceptance of our Investigational New Drug application and Fast Track designation by the FDA for rhenium (186Re) obisbemeda for the treatment of LM in November 2021, we initiated the trial and began screening patients for the ReSPECT-LM Phase 1 clinical trial in the fourth quarter of 2021.
ReSPECT-LM is a multi-center, sequential cohort, open-label, dose escalation study evaluating the safety, tolerability, and efficacy of a single-dose application of rhenium (186Re) obisbemeda administered through intrathecal infusion to the ventricle of patients with LM after standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events and dose limiting toxicities, together with determining the maximum tolerated and recommended Phase 2 dose. Full enrollment in the Phase 1 trial was achieved at the end of 2024, and we announced the trial completion on February 26, 2025. Trial closeout procedures are now taking place including final data review and monitoring, and a clinical study report and manuscript will be prepared.
On September 19, 2022, we entered into a Cancer Research Grant Contract (the “CPRIT Contract”), effective as of August 31, 2022, with CPRIT, pursuant to which CPRIT provides us a grant of up to $17.6 million (the “CPRIT Grant”) over a three-year period to fund the continued development of rhenium (186Re) obisbemeda for the treatment of patients with LM through Phase 2 of the ReSPECT-LM clinical trial. The CPRIT Grant is subject to customary CPRIT funding conditions, including, but not limited to, a matching fund requirement (one dollar from us for every two dollars awarded by CPRIT), revenue sharing obligations upon commercialization of rhenium (186Re) obisbemeda based on specific dollar thresholds until CPRIT receives the aggregate amount of 400% of the proceeds awarded under the CPRIT Grant, and certain reporting requirements. As of March 31, 2026, we had received approximately $15.9 million in milestone payments under the CPRIT Contract.
Interim results showed that a single treatment with rhenium (186Re) obisbemeda resulted in a consistent decreased cerebrospinal fluid (“CSF”) tumor cell count/ml and was tolerated by all LM patients. Rhenium (186Re) obisbemeda is an outpatient administration and treatment and is easily and safely administered through a standard intraventricular catheter (Ommaya Reservoir), distributed promptly throughout the CSF, and with durable retention in the leptomeninges at least through day seven. All patients have shown well tolerated prompt and durable rhenium (186Re) obisbemeda distribution throughout the subarachnoid space.
In November 2023, the FDA granted orphan drug designation to rhenium (186Re) obisbemeda for the treatment of patients with breast cancer with LM.
On December 12, 2023, we announced our partnership with K2bio to implement the CNSide Test.
On February 26, 2025, we announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined a recommended Phase 2 dose. Enrollment in Cohort 6 was completed (75.0 mCi). The Cohort 4 dose (44.1 mCi) was determined to be the recommended Phase 2 dose with no dose-limiting toxicities observed at that dose level. One patient at the Cohort 4 dose was observed to have achieved a complete response, as evidenced by the eradication of tumor cells in the cerebrospinal fluid—a key therapeutic endpoint.
In March 2025, the FDA granted orphan drug designation to rhenium (186Re) obisbemeda for the treatment of LM in patients with lung cancer.
In November 2025, we had our end of phase 1 meeting with the FDA. During this meeting, FDA conveyed that while accelerated approval may be appropriate for this indication, there are insufficient data to support the use of CTCs as an intermediate clinical endpoint, and there was discussion that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications. The FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of reported outcomes and neurologic function as endpoints that could potentially support a marketing application. We were aligned that CTCs could be considered for use as a secondary endpoint. We discussed with the FDA a randomized controlled trial design approach and that the study may include an itrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol. The FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial. We plan to consider the Agency’s feedback and propose an updated protocol for our next study for FDA’s feedback.
In December 2025, we reported completion of the ReSPECT-LM single dose trial showed rhenium (186Re) obisbemeda was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed. We also reported the ReSPECT-LM open label, multidose Phase 1/2 trial initiation to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses at optimal dose selected by assessing response
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using the CNSide Test. Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals with one patient receiving all doses without dose limiting toxicity.
Our ReSPECT LM Multi-dose Phase 2 Study is currently enrolling patients.
ReSPECT-PBC Clinical Trial for Pediatric Brain Cancer
The average annual age adjusted mortality rate for children aged 0-14 for malignant brain (and other CNS) tumors is 0.71/100,000, making it the most common cause of death and cancer death in this age group. The 2021 World Health Organization Classification of CNS Tumors classifies gliomas, glioneuronal tumors, and neuronal tumors into six different families: (1) adult-type diffuse gliomas; (2) pediatric-type diffuse low-grade gliomas; (3) pediatric-type diffuse high-grade gliomas (“HGG”); (4) circumscribed astrocytic gliomas; (5) glioneuronal and neuronal tumors; and (6) ependymomas.
In August 2021, we announced plans for treating pediatric brain cancer at the 2021 American Association of Neurological Surgeons Annual Scientific Meeting. In July 2021, we reported that we had received FDA feedback pertaining to a pre-Investigational New Drug Application (“IND”) meeting briefing package in which the FDA stated that we are not required to perform any additional preclinical or toxicology studies.
Pediatric high-grade gliomas can be found almost anywhere within the CNS; however, they are most commonly found within the supratentorium. While cases occur across the pediatric age spectrum and the overall median age at diagnosis is approximately nine years, the highest incidence of supratentorial high-grade gliomas is observed in older adolescents aged 15 to 19 years. Overall, pediatric high-grade glioma confers a three-year progression free survival (“PFS”) of 11 ± 3% and three-year OS of 22 ±5%. One-year PFS is as low as 40% in recent trials. Ependymomas are slow-growing central nervous system tumors that involve the ventricular system. Diagnosis is based on MRI and biopsy and survival rate depends on tumor grade and how much of the tumor can be removed. Grade II pathology was associated with significantly improved OS compared to Grade III (anaplastic) pathology (five-year OS = 71 ± 5% vs. 57 ± 10%; p = 0.026). Gross total resection compared to subtotal resection was associated with significantly improved OS (five-year OS = 75 ± 5% vs. 54 ± 8%; p = 0.002).
Overall, pediatric HGG and ependymoma are extremely difficult-to-treat pediatric brain tumors, frequently aggressive, and in recurrent settings, carry an extremely poor prognosis.
Effective September 1, 2024, we entered into an agreement with the Department of Defense office of the Congressionally Directed Medical Research Programs to receive a $3.0 million fund for research and development purposes (“DoD Award”) over a three-year period. The DoD Award will be used to support the planned expansion of our clinical trial for pediatric brain cancer. We anticipate enrolling for our first patient for our Phase 1 ReSPECT-PBC clinical trial in 2026.
Key elements of the trial design include:
On April 8, 2026, we announced that the FDA granted Orphan Drug Designation to rhenium (186Re) obisbemeda for the treatment of pediatric malignant gliomas.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere Technology
In January 2022, we announced that we licensed Biodegradable Alginate Microsphere (“BAM”) patents and technology from The University of Texas Health Science Center at San Antonio (“UTHSCSA”) to expand our tumor targeting capabilities and precision radiotherapeutics pipeline. We intend to combine our Rhenium In January 2022, we announced that we licensed Biodegradable Alginate Microsphere (“BAM”) patents and technology from The University of Texas Health Science Center at San Antonio (“UTHSCSA”) to expand our tumor targeting capabilities and precision radiotherapeutics pipeline. We intend to combine our Rhenium NanoLiposome technology with the BAM technology to create a novel radioembolization technology. Initially, we intend to utilize the Rhenium-188 isotope, 188RNL-BAM for the intra-arterial embolization and local delivery of a high dose of targeted radiation for a variety of solid organ cancers such as hepatocellular cancer, hepatic metastases, pancreatic cancer and many others.
Preclinical data from an ex vivo embolization experiment in which Technetium99m-BAM was intra-arterially delivered to a bovine kidney perfusion model was presented at the Society of Interventional Radiology Annual Scientific Meeting. The study concluded that the technology required for radiolabeling BAM could successfully deliver, embolize and retain radiation in the target organ. 188RNL-BAM is a preclinical investigational device we intend to further develop and move into clinical trials. Specifically, in 2022 we transferred the 188RNL-BAM technology from UTHSCSA, and began planning to develop the product and complete early preclinical studies to support a future FDA IND submission. Our intended initial clinical target is liver cancer which is the sixth most common and third deadliest cancer worldwide. It is a rare disease with increasing U.S. annual incidence (42,000) and deaths (30,000).
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The FDA has informed us that 188RNL-BAM will be regulated as a medical device under the FDCA.
The CNSide CSF Assay Platform
The CNSide CSF Assay Platform consists of four LDTs used for detection, quantification, and characterization of tumor cells in patients with LM. The CNSide Platform facilitates tumor cell detection/enumeration and biomarker identification using cellular assays (tumor cell enumeration (“TCE”), immunocytochemistry (“ICC”), and fluorescence in situ hybridization (“FISH”)) and molecular assays (next-generation sequencing (“NGS”)). The CNSide Test is currently being used in the ReSPECT-LM trial as an exploratory endpoint.
Since acquiring the CNSide Platform in 2024, we have established infrastructure to support a scalable and centralized testing laboratory in Houston, TX that services the U.S. market. We have been executing on our commercial market access strategy, which includes state licensure, receipt of proprietary reimbursement codes, commercial and government payor coverage, and value-based pricing to optimize revenue. We re-introduced the CNSide Platform first in Texas in August of 2025, signed a national agreement to provide the CNSide Test with UnitedHealthcare Insurance Company, Humana, Inc., Highmark and Blue Shield of California, and obtained state licensure for 49 of 50 US states, with the remaining license for the state of New York on track for 2027. In parallel, we expect to launch a portfolio of additional CSF tumor characterization tests that expand our CNSide testing platform later in 2026.
When the CNSide CSF Assay Platform was previously commercially available, market acceptance and adoption were widespread, with several national and regional commercial payor agreements in place and the test in regular use at major cancer centers across the U.S. Finally, we have hired experienced leadership with expertise in the development and commercialization of clinical diagnostic technologies on a large scale.
During the three months ended March 31, 2026, we started commercial billing for our diagnostic CNSide business. Net diagnostic revenue was immaterial to be presented in the condensed consolidated statement of operations for the three months ended March 31, 2026 (refer to Note 2 Summary of Significant Accounting Policies of the footnotes). In April 2026, management obtained approval of proprietary laboratory analyses codes from significant medical payors, and will continue to seek additional authorizations. We expect diagnostic revenue to increase during the remainder of 2026 and beyond.
Recent Developments
Recent Financings
Refer to the “Liquidity and Capital Resources” section below for information on our recent financings.
Results of Operations
CPRIT Grant Revenue
We recognized $1.0 million and $1.1 million of grant revenue during the three months ended March 31, 2026 and 2025, respectively, which represents CPRIT’s share of the costs incurred for our rhenium (186Re) obisbemeda development for the treatment of patients with LM.
Research and development expenses
Research and development expenses include costs associated with the design, development, testing, and enhancement of our product candidates, payment of regulatory fees, laboratory supplies, preclinical studies, and clinical studies.
The following table summarizes the components of our research and development expenses for the three months ended March 31, 2026 and 2025 (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Research and development |
|
$ |
2,860 |
|
|
$ |
1,749 |
|
Stock-based compensation |
|
|
5 |
|
|
|
7 |
|
Total research and development expenses |
|
$ |
2,865 |
|
|
$ |
1,756 |
|
Research and development expenses increased by approximately $1.1 million during the three months ended March 31, 2026 as compared to the same period in 2025. The increase was due primarily to an increase of $0.4 million in clinical expenses, $0.3 million in diagnostics, $0.3 million in professional research and development services, and $0.1 million in other research and development expenses.
We expect aggregate research and development expenditures to increase during the remainder of 2026 as compared to the corresponding comparable period in 2025, due to increased costs for the ReSPECT-LM clinical trial (for which CPRIT grant funding is expected to be available), manufacturing scale up for rhenium (186Re) obisbemeda commercial and approval trial drug availability and initial patient enrollments in the ReSPECT-PBC clinical trial together with expansion of CNSide research and development teams.
General and administrative expenses
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General and administrative expenses include costs for administrative personnel, legal and other professional expenses, and general corporate expenses. The following table summarizes the general and administrative expenses for the three months ended March 31, 2026 and 2025 (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
General and administrative |
|
$ |
4,265 |
|
|
$ |
2,698 |
|
Stock-based compensation |
|
|
1,017 |
|
|
|
141 |
|
Total general and administrative expenses |
|
$ |
5,282 |
|
|
$ |
2,839 |
|
General and administrative expenses increased by $2.4 million during the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to an increase of $1.4 million in compensation expense which included an increase of $0.9 million in stock based compensation, $0.5 million in legal and professional fees, $0.3 million in rent expense, and $0.2 million in other general and administrative expenses.
We expect general and administrative expenditures to increase during the remainder of 2026 as compared to the corresponding comparable period in 2025 as we expand the CNSide commercial operations team (including sales, customer service and laboratory operations).
Stock-based compensation expenses
Stock-based compensation expenses include charges related to options and restricted stock awards issued to employees, directors and non-employees. We measure stock-based compensation expenses based on the grant-date fair value of any awards granted to our employees. Such expense is recognized over the requisite service period.
The following table summarizes the components of our stock-based compensation expenses for the three months ended March 31, 2026 and 2025 (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Research and development |
|
$ |
5 |
|
|
$ |
7 |
|
General and administrative |
|
|
1,017 |
|
|
|
141 |
|
Total stock-based compensation |
|
$ |
1,022 |
|
|
$ |
148 |
|
Our stock-based compensation expense is impacted by grants of equity awards, the vesting schedule of such grants, as well as the grant date fair value of equity awards. Stock-based compensation expense increased during the three months ended March 31, 2026 as compared to the same period in 2025 primarily due to an increase in the number of awards granted, which was partially offset by a decrease in the grant date fair value of equity awards granted.
Other Income (Expense)
The following table summarizes non-operating income and expenses for the three months ended March 31, 2026 and 2025 (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Interest income |
|
$ |
190 |
|
|
$ |
1 |
|
Interest expense |
|
|
(17 |
) |
|
|
(548 |
) |
Financing expenses |
|
|
— |
|
|
|
(3,211 |
) |
Change in fair value of derivative instruments |
|
|
— |
|
|
|
(9,143 |
) |
Warrant issuance costs |
|
|
— |
|
|
|
(964 |
) |
Total |
|
$ |
173 |
|
|
$ |
(13,865 |
) |
Interest income increased for the three months ended March 31, 2026 compared with the same period in 2025 was primarily due to a higher investment balance in 2026 as compared to the same period in 2025.
The decrease in interest expense for the three months ended March 31, 2026 as compared to the same period in 2025 was due to interest related to the Funding Notes issued and redeemed during the three months ended March 31, 2025.
Financing expenses for the three months ended March 31, 2025 related to the March 2025 PIPE and February 2025 transactions.
The change in the fair value of the derivative instruments for the three months ended March 31, 2025 was primarily due to the March 2025 Private Placement (specifically the liability classified March 2025 Series B Warrants, which were remeasured immediately prior to exercise, before being reclassified as equity).
Warrant issuance costs for the three months ended March 31, 2025 related to the March 2025 Private Placement.
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Liquidity and Capital Resources
Short-term and long-term liquidity
The following is a summary of our key liquidity measures at March 31, 2026 and December 31, 2025 (in thousands):
|
|
|
|
|||||
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Cash, cash equivalents and restricted cash |
|
$ |
3,022 |
|
|
$ |
8,758 |
|
|
|
|
|
|
|
|
||
Current assets |
|
$ |
18,028 |
|
|
$ |
15,170 |
|
Current liabilities |
|
|
7,955 |
|
|
|
12,314 |
|
Working capital |
|
$ |
10,073 |
|
|
$ |
2,856 |
|
We incurred net losses of $6.9 million for the three months ended March 31, 2026. We have an accumulated deficit of $522.8 million as of March 31, 2026. Additionally, we used net cash of $6.2 million to fund our operating activities for the three months ended March 31, 2026. These factors raise substantial doubt about our ability to continue as a going concern.
To date, our operating losses have been funded primarily from outside sources of invested capital from issuance of our common and preferred equity, warrants, convertible loan, warrants, term loan, our line of credit facility with Pershing and grant funding. We have had, and will continue to have, an ongoing need to raise additional cash from outside sources to fund our future clinical development programs and other operations. There can be no assurance that we will be able to continue to raise additional capital in the future. Our inability to raise additional cash would have a material and adverse impact on our operations and ability to satisfy our obligations.
January 2026 Public Offering
On January 13, 2026, the Company completed an underwritten public offering pursuant to which the Company (a) sold an aggregate of (i) 1,578,947 shares of common stock, par value $ 0.001 per share, of the Company and (ii) warrants to purchase 1,578,947 shares of common stock (the “January 2026 Warrants”), at a combined public offering price of $9.50 per share and January 2026 Warrant, and (b) granted the underwriter a 30-day option to purchase up to an additional 236,837 shares of common stock, additional January 2026 Warrants to purchase up to 236,837 shares of common stock or any combination thereof, at the public offering price, in each case less underwriting discounts and commissions. Each January 2026 Warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an exercise price of $9.50 per share and expires five (5) years from the date of issuance. On January 14, 2026, the underwriter exercised its over-allotment option with respect to additional January 2026 Warrants to purchase 236,837 shares of common stock. Net proceeds from the underwritten public offering were approximately $13.9 million after deducting the underwriting discounts and commissions and other offering expenses payable by the Company.
February 2025 SPEA
On February 13, 2025 (the “February 2025 SPEA Closing Date”), we entered into a securities purchase and exchange agreement (the “February 2025 SPEA”) with certain existing accredited investors. Pursuant to the February 2025 SPEA, on the February 2025 SPEA Closing Date we issued secured convertible promissory notes (the “Funding Notes”) in the aggregate principal amount of $3.3 million together with common stock purchase warrants (the “February 2025 Warrants”) to purchase 120,080 shares of our common stock at an exercise price of $28.00 per share. The aggregate purchase price for the Funding Note and February 2025 Warrants was approximately $3.7 million and included payment of $3.125 per February 2025 Warrant in accordance with the listing rules of Nasdaq.
Exchange Notes
The May 2024 Purchase Agreement (as described below) included certain limitations and restrictions on our ability to issue securities and provided the May 2024 Private Placement Purchasers other than our directors and executive officers (the “Outside Investors”) participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the “Financing Restrictions”). On the February 2025 SPEA Closing Date, pursuant to the February 2025 SPEA, we issued to the Outside Investors secured convertible promissory notes in the aggregate amount of $3.2 million (the “Exchange Notes”) in exchange for cancellation of the 141,729 May 2024 Series A Warrants held by them, and the Outside Investors entered into a second amendment to the May 2024 Purchase Agreement to eliminate the Financing Restrictions.
As described below, we repurchased the Funding Notes and issued common stock and warrants for cancellation of the Exchange Notes in connection with the March 2025 Private Placement.
March 2025 Private Placement
On March 4, 2025, we entered into the March 2025 SPA with the March 2025 Private Placement Purchasers for the March 2025 Private Placement for gross proceeds of approximately $15.0 million. Pursuant to the March 2025 Purchase Agreement, we issued an aggregate of 162,789 shares (the “March 2025 Private Placement Shares”) of our common stock and 958,896 Pre-Funded Warrants, with each March 2025 Private Placement Share or Pre-Funded Warrant accompanied by (i) the March 2025 Series A Warrants to purchase one share of common stock and (ii) one March 2025 Series B Warrant to purchase one share of common stock.
The initial exercise price of each March 2025 Series A Warrant is $33.00 per share of common stock. The March 2025 Series A Warrants are exercisable only following stockholder approval and expire five (5) years thereafter. The March 2025 Series A Warrants are subject
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to certain price reset, share combination event and anti-dilution provisions which, if triggered, provide that the number of shares issuable upon exercise of the March 2025 Series A Warrants will downward adjust, subject to the Floor Price, and the number of shares issuable upon exercise therefor will increase such that the aggregate exercise price remains unchanged.
The initial exercise price of each March 2025 Series B Warrant is $49.50 per share of common stock. The March 2025 Series B Warrants are exercisable only following stockholder approval and expire two and one-half (2.5) years thereafter. The March 2025 Series B Warrants are subject to certain price reset and share combination event provisions which, if triggered, provide that the number of shares issuable upon exercise of the March 2025 Series B Warrants will downward adjust, subject to the Floor Price, and the number of shares issuable upon exercise therefor will increase such that the aggregate exercise price remains unchanged. In addition, the March 2025 Series B Warrant alternative cashless exercise provision provides that the March 2025 Series B Warrant can be exercised without further payment to us and for three times the number of shares of common stock then subject to the March 2025 Series B Warrant.
Of the securities issued in the March 2025 Private Placement, 123,090 shares of Common Stock, 786,000 shares of March 2025 Pre-Funded Warrants in lieu thereof, and the accompanying 909,090 March 2025 Series A Warrants and 909,090 March 2025 Series B Warrants, were issued in consideration of new capital subscriptions, and 39,698 shares of Common Stock, 172,896 March 2025 Pre-Funded Warrants in lieu thereof, and the accompanying 212,594 March 2025 Series A Warrants and 212,594 March 2025 Series B Warrants, were issued in exchange for the cancelation of the Exchange Notes.
The March 2025 Private Placement closed on March 7, 2025. The aggregate gross proceeds at the closing were approximately $15.0 million, before deducting $1.4 million of expenses payable by us.
On May 2, 2025, our stockholders approved, among other things, the March 2025 Series A Warrants and March 2025 Series B Warrants and an amendment of our Certificate of Incorporation, as amended, to increase the authorized share capital to an amount sufficient to cover the shares of common stock issuable upon the exercise of the March 2025 Series A Warrants and March 2025 Series B Warrants. As part of the March 2025 Series A Warrants and March 2025 Series B Warrants agreement, the exercise price of the March 2025 Series A Warrants and March 2023 Series B Warrants were reset on May 19, 2025 to $10.9325 per share. Prior to modification of the March 2025 Series B Warrants as part of the Letter Agreement (as further described below), certain March 2025 Series B Warrants were cashless exercised for the issuance of 859,299 shares of common stock.
Letter Agreement
On June 17, 2025, the Company and the Purchasers entered into the Letter Agreement with each of the Purchasers in an effort to, among other items, minimize the dilutive impact of the March 2025 Private Placement. The Letter Agreement extinguished the March 2025 Series A Warrants, modified the March 2025 Series B Warrants, and provided for the return of Private Placement Shares and Pre-Funded Warrants, as further discussed in the following paragraphs.
As part of the same transaction, the March 2025 Series B Warrants were amended (“Amended March 2025 Series B Warrants”), to (a) reduce the overall number of March 2025 Series B Warrant Shares issuable upon exercise of the Series B Warrants to an aggregate of up to 1,421,455 Series B Warrant Shares, (b) reduce the alternative cashless exercise ratio in such March 2025 Series B Warrants from 3:1 to 1:1, and (c) remove provisions contained in the March 2025 Series B Warrants that would otherwise reduce the Company’s stockholders’ equity. As a result of the Letter Agreement, the Amended March 2025 Series B Warrants no longer fail the indexation guidance under ASC 815, Derivatives and Hedging, and the fair value of the warrant liability was reclassified to equity. After the June 17, 2025 modification, 1,391,781 Amended March 2025 Series B Warrants were cashless exercised.
Lastly, in conjunction with the Letter Agreement, each of the March 2025 Private Placement Purchasers agreed to the Letter Agreement Repurchase Option, to return an aggregate of 489,679 Private Placement Shares and Pre-Funded Warrants issuable for an aggregate of 425,346 Pre-Funded Warrant Shares, held by them as of the date of the Letter Agreement, upon request of the Company, which were issued pursuant to the March 2025 Private Placement Purchase Agreement for a value of $16.50 per Private Placement Share and $16.475 per Pre-Funded Warrant. In exchange therefor, the Company agreed to repay the March 2025 Private Placement Purchasers holding such securities 115% of such value, using 90% of the proceeds from any capital raised by the Company subsequent to July 1, 2025. The Company and each of the March 2025 Private Placement Purchasers also agreed to waive any restrictions on subsequent equity sales and variable rate transactions contained in March 2025 Private Placement Purchase Agreement to allow for such repayment. During the three months ended March 31, 2026, we paid the March 2025 Private Placement Purchasers $4.5 million and 272,821 shares were returned and cancelled under the terms of the Letter Agreement.
Support Letters
On July 11, 2025, we and certain March 2025 Private Placement Purchasers party to the Letter Agreement entered into that certain letter of support (the “Support Letters”) to modify certain portions of the Letter Agreement as between us and each of such March 2025 Private Placement Purchasers. In the event that we reasonably believe that, within the 30 days (the “Modification Period”) prior to the end of any fiscal quarter, we will have stockholders’ equity in an amount below $3.0 million as of the end of such fiscal quarter (the “Potential Equity Deficiency”), the Subsequent Financing Percentage (as defined in the Letter Agreement) shall be modified from 90% to 50% for any Subsequent Financing (as defined in the Letter Agreement) that occurs during the Modification Period pursuant to the Lincoln Park Purchase Agreement. Upon the end of the Modification Period, the Subsequent Financing Percentage shall be reverted to 90%, and such percentage shall apply to all Subsequent Financings, including all Subsequent Financings pursuant to the Lincoln Park Purchase Agreement. In the event we desire to trigger the modification of the Subsequent Financing Percentage, we agree to supply the purchaser who executed a Support Letter with a pro forma balance sheet to evidence its reasonable belief of the Potential Equity Deficiency
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approximately 30 days prior to each end of fiscal quarter once the books for prior months are closed. Each Support Letter also grants the purchaser party to the letter a participation right in certain future financings of ours for a period of 12 months.
First Amendment to the February 2025 SPEA
In connection with the March 2025 Purchase Agreement, we entered into that certain First Amendment to the February 2025 SPEA (the “First Amendment”). The February 2025 SPEA included certain limitations and restrictions on our ability to issue securities and provided the investors participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the “New Financing Restrictions”). Pursuant to the First Amendment, subject to consummation of the March 2025 Private Placement, we agreed to repurchase from the Investors $3.4 million in principal amount of the Funding Notes and accrued interest, along with the February 2025 Warrants issued pursuant to the February 2025 SPEA for an aggregate purchase price of $4.2 million. In exchange for the repurchase by us of the Funding Notes and February 2025 SPEA Warrants, the February 2025 Purchasers agreed to consent to the March 2025 Private Placement and eliminate the New Financing Restrictions.
Lincoln Park Purchase Agreement
On June 17, 2025, we entered into a purchase agreement (the “Lincoln Park Purchase Agreement”) and a registration rights agreement pursuant to which Lincoln Park Capital Fund (“Lincoln Park”) committed to purchase up to $50.0 million of shares of our common stock. Under the terms and subject to the conditions of the Lincoln Park Purchase Agreement, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $50.0 million of shares of our common stock. Sales of common stock by us are subject to certain limitations, and can occur from time to time, at our sole discretion, over the 36-month period commencing on June 23, 2025, subject to the satisfaction of certain conditions. Actual sales of shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of the common stock and our determinations as to the appropriate sources of funding for the Company and its operations. As consideration for Lincoln Park’s irrevocable commitment to purchase shares of our common stock upon the terms of and subject to satisfaction of the conditions set forth in the Lincoln Park Purchase Agreement,
On June 23, 2025, a registration statement (the “Initial Registration Statement”) was declared effective covering the resale of up to 680,000 shares of our common stock. On August 14, 2025, a registration statement (the “Second Registration Statement”) was declared effective covering the resale of up to 1,320,000 shares of our common stock.
The initial commitment fee was recorded as a reduction to additional paid-in capital in the condensed consolidated balance sheet. An additional commitment fee of $0.5 million will be paid in cash or shares of common stock, or a combination of cash and shares of common stock, if and when we sell over $25.0 million of our common stock under the Lincoln Park Purchase Agreement.
Nasdaq Listing Compliance
Minimum Stockholders’ Equity Requirement
We are currently in compliance with the Minimum Stockholders’ Equity Requirement. We are subject to monitoring through August 22, 2026 with respect to the Minimum Stockholders’ Equity Requirement. If, within such period, the Staff determines that we no longer satisfy the Minimum Stockholders’ Equity Requirement (and we are not then in compliance with one of the alternative standards under Nasdaq Listing Rule 5550(b)), we will not be permitted to provide the Staff with a plan of compliance and the Staff is not permitted to grant additional time to regain compliance with the Minimum Stockholders’ Equity Requirement nor will we be afforded an applicable cure or compliance period. Instead, the Staff will issue a delist determination letter, and we will have an opportunity to request a new hearing before the Nasdaq Hearings Panel, which request would stay any further action by the Staff pending the ultimate outcome of the hearing.
Minimum Bid Requirement
On April 20, 2026, we received the Notification Letter from The Nasdaq Stock Market LLC notifying us that we had regained compliance with the Minimum Bid Requirement. The Notification Letter was sent following the implementation of the Reverse Stock Split, which became effective on April 2, 2026. Additional information regarding the Reverse Split can be found in our Current Report on Form 8-K filed on April 2, 2026.
Funding and Material Cash Requirements
To date, our operating losses have been funded primarily from outside sources of invested capital from issuance of shares of our common and preferred equity, warrants, convertible loan, warrants, term loan, the margin loan facility under a line of credit with Pershing and grant funding. However, we have had, and will continue to have, an ongoing need to raise additional cash from outside sources through a combination of equity offerings, debt financings and potential collaboration, license or development agreements to fund our future clinical development programs, commercialization of CNSide, and other operations in the next twelve months from the filing of this Quarterly Report. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. There can be no assurance that we will be able to continue to raise additional capital in the future. Our inability to raise additional cash would have a material adverse impact on our operations, implementation of our strategy and ability to maintain compliance with applicable requirements, including Nasdaq listing rules.
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Our present and future funding and cash requirements will depend on many factors, including, among other things:
The accompanying condensed consolidated financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to our ability to continue as a going concern.
Cash (used in) provided by operating, investing, and financing activities for the three months ended March 31, 2026 and 2025 is summarized as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
Net cash provided by (used in): |
|
2026 |
|
|
2025 |
|
||
Operating activities |
|
$ |
(6,238 |
) |
|
$ |
(6,172 |
) |
Investing activities |
|
|
(8,533 |
) |
|
|
3,558 |
|
Financing activities |
|
|
9,035 |
|
|
|
12,405 |
|
Net change in cash and cash equivalents |
|
$ |
(5,736 |
) |
|
$ |
9,791 |
|
Material Cash Obligations
Under the CPRIT Contract, we receive matching funds for approximately two-thirds of the development costs for the development of REYOBIQ for the treatment of patients with LM, subject to various funding conditions. The CPRIT Contract is effective for three years, unless otherwise terminated pursuant to the terms of the contract. CPRIT may require us to repay some or all of the disbursed CPRIT Grant proceeds (with interest not to exceed 5% annually) in the event of the early termination of the CPRIT Contract.
Other than as described above, we have no purchase commitments or long-term contractual obligations, except for lease obligations as of March 31, 2026. In addition, we have no off-balance sheet arrangements (as defined in the rules and regulations of the SEC) that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Operating activities
Net cash used in operating activities for the three months ended March 31, 2026 of $6.2 million was primarily related to the net loss of $6.9 million and $0.4 million of changes to operating assets and liabilities, partially offset by $1.0 million of stock-based compensation expense and $0.1 million of depreciation and amortization.
Net cash used in operating activities for the three months ended March 31, 2025 was $6.2 million, compared with $4.5 million in the same period of 2024, primarily due to an increase to net loss of $14.1 million, offset by non cash charges of $12.7 million during the three months ended March 31, 2025.
Investing activities
Net cash used in investing activities for the three months ended March 31, 2026 of $8.5 million was primarily related to the purchase of short-term investments of $9.7 million and purchase of property and equipment of $0.8 million, which was partially offset by the redemption of short-term investments of $2.0 million.
Net cash provided by investing activities for the three months ended March 31, 2025 was related to maturities of short-term investments of $3.5 million.
32
Table of Contents
Financing Activities
Net cash provided by financing activities for the three months ended March 31, 2026 of $9.0 million was related to $15.0 million in proceeds from the January 2026 underwritten public offering and $1.0 million of proceeds from the credit facility, partially offset by $1.1 million repayments of the credit facility, $1.4 million for offering costs for the sale of common stock, and $4.5 million of payments to investors pursuant to the Letter Agreement.
Net cash provided by financing activities for the three months ended March 31, 2025 was related to $14.8 million of net proceeds from issuance of common stock, pre-funded warrants and warrants, $0.9 million related to cash received from exercise of warrants, and $3.7 million from issuance of Funding Notes payable and accompanying warrants, offset by repayment of $3.3 million of our line of credit facility, and repayment of Funding Notes payable and warrants for $3.7 million.
Critical Accounting Policies and Significant Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the reported amounts of our assets, liabilities, revenues and expenses, and that affect our recognition and disclosure of contingent assets and liabilities.
While our estimates are based on assumptions we consider reasonable at the time they were made, our actual results may differ from our estimates, perhaps significantly. If results differ materially from our estimates, we will make adjustments to our consolidated financial statements prospectively as we become aware of the necessity for an adjustment.
We believe it is important for you to understand our most critical accounting policies. Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and there have been no material changes during the three months ended March 31, 2026, other than what was disclosed in Note 2 Summary of Significant Accounting Policies of the accompanying condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed in our reports that we file or furnish pursuant to the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Rule 13a-15(b) under the Exchange Act we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer), of the effectiveness of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and 15d-15(e) promulgated under the Exchange Act as of the end of the period covered by this Quarterly Report. Based on the foregoing, our Chief Executive Officer (our principal executive officer) and Chief Financial Officer (our principal financial officer and principal accounting officer) concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were effective at the reasonable assurance level as of the end of the period covered by this Quarterly Report.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II.
Item 1. Legal Proceedings
None.
33
Table of Contents
Item 1A. Risk Factors
There have been no material changes to the risk factors disclosed in Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
2(a): Unregistered Sales of Equity Securities and Use of Proceeds
None.
2(b): Use of Proceeds from Registered Securities
None.
2(c): Purchases of Equity Securities
The following table provides certain information with respect to the Company's purchases of its common stock for the three months ended March 31, 2026.
|
|
Company Purchases of Common Stock |
|
|||||||||||||
Period |
|
Total Number of Shares Purchased |
|
|
Average Price Paid per Share |
|
|
Total Number of Shares Purchased As Part of Publicly Announced Plans or Programs |
|
|
Approximate Dollar Value of Shares That May Yet Be Purchased Under Plans or Programs(1) |
|
||||
January 1 - 31, 2026 |
|
|
272,821 |
|
|
$ |
16.50 |
|
|
|
272,821 |
|
|
$ |
- |
|
February 1 - 28, 2026 |
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
$ |
- |
|
March 1 - 31, 2026 |
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
$ |
- |
|
Total |
|
|
272,821 |
|
|
$ |
- |
|
|
|
272,821 |
|
|
$ |
- |
|
Item 5. Other Information
On May 12, 2026, the Company filed a Certificate of Correction (the “Certificate of Correction”) to a Certificate of Amendment to the Amended and Restated Certificate of Incorporation of the Company (the “Certificate of Amendment”) that was previously filed on April 1, 2026. The Certificate of Amendment erroneously stated the number of authorized shares of common stock, par value $0.001 per share, of the Company (“Common Stock”) as 200,000,000 (two hundred million).
As corrected by the Certificate of Correction, the total number of authorized shares of Common Stock is two billion (2,000,000,000).
34
Table of Contents
Item 6. Exhibits
EXHIBIT INDEX
PLUS THERAPEUTICS, INC.
Exhibit Number |
Exhibit Title |
Filed with this Form 10-Q |
Incorporated by Reference |
||
Form |
File No. |
Date Filed |
|||
3.1 |
Composite Certificate of Incorporation |
|
10-K |
001-34375 Exhibit 3.1 |
03/11/2016 |
|
|
|
|
|
|
3.2 |
Certificate of Amendment to Amended and Restated Certificate |
|
8-K |
001-34375 Exhibit 3.1 |
05/10/2016 |
|
|
|
|
|
|
3.3 |
Certificate of Amendment to Amended and Restated Certificate |
|
8-K |
001-34375 Exhibit 3.1 |
05/23/2018 |
|
|
|
|
|
|
3.4 |
Certificate of Amendment to Amended and Restated Certificate |
|
8-K |
001-34375 Exhibit 3.1 |
07/29/2019 |
|
|
|
|
|
|
3.5 |
Certificate of Amendment to Amended and Restated Certificate |
|
8-K |
001-34375 Exhibit 3.1 |
08/06/2019 |
|
|
|
|
|
|
3.6 |
Certificate of Amendment to Amended and Restated Certificate |
|
8-K |
001-34375 Exhibit 3.1 |
04/28/2023 |
|
|
|
|
|
|
3.7 |
Certificate of Amendment to the Certificate of Incorporation, as amended |
|
8-K |
001-34375 Exhibit 3.1 |
05/02/2025 |
|
|
|
|
|
|
3.8 |
Certificate of Amendment to the Amended and Restated Certificate of Incorporation, filed with the Delaware Secretary of State on April 1, 2026 |
X |
|
|
|
|
|
|
|
|
|
3.9 |
Certificate of Correction to the Amended and Restated Certificate filed with the Delaware Secretary of State on May 12, 2026 |
X |
|
|
|
|
|
|
|
|
|
3.10 |
Amended and Restated Bylaws of Plus Therapeutics, Inc. |
|
8-K |
001-34375 Exhibit 3.1 |
09/21/2021 |
|
|
|
|
|
|
3.11 |
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock |
|
8-K |
001-34375 Exhibit 3.1 |
11/28/2017 |
|
|
|
|
|
|
3.12 |
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock |
|
8-K |
001-34375 Exhibit 3.1 |
07/25/2018 |
|
|
|
|
|
|
3.13 |
2020 Stock Incentive Plan, as amended and restated on May 14, 2026 |
X |
|
|
|
|
|
|
|
|
|
4.1 |
Description of Securities |
|
10-K |
001-34375 Exhibit 4.1 |
03/30/2020 |
|
|
|
|
|
|
4.2 |
Form of Common Stock Certificate |
|
10-K |
001-34375 Exhibit 4.33 |
03/09/2018 |
|
|
|
|
|
|
4.3 |
Form of Pre-Funded Warrant |
|
8-K |
001-34375 Exhibit 4.1 |
05/09/2024 |
|
|
|
|
|
|
4.4 |
Form of Amendment and Restatement of the May 2024 Series A Warrant |
|
10-Q |
011-34375 |
08/14/2024 |
|
|
|
|
|
|
4.5 |
Form of Amendment and Restatement of the May 2024 Series B Warrant |
|
10-Q |
011-34375 |
08/14/2024 |
|
|
|
|
|
|
4.6 |
Form of Pre-Funded Warrant |
|
8-K |
011-34375 |
02/18/2025 |
35
Table of Contents
|
|
|
|
|
|
4.7 |
Form of Warrant issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc. and the purchasers named therein |
|
8-K |
001-34375 Exhibit 4.2 |
02/18/2025
|
|
|
|
|
|
|
4.8 |
Form of Pre-Funded Warrant |
|
8-K
|
001-34375 Exhibit 4.1 |
03/04/2025 |
|
|
|
|
|
|
4.9 |
Form of Amended March 2025 Series B Warrant |
|
8-K
|
001-34375 Exhibit 4.1 |
06/17/2025 |
|
|
|
|
|
|
4.10 |
Form of Warrant, dated January 15, 2026 |
|
8-K |
001-34375 Exhibit 4.1 |
01/16/2026 |
|
|
|
|
|
|
31.1* |
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-1.04(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
X
|
|
|
|
|
|
|
|
|
|
31.2*
|
Certification of Principal Financial and Accounting Officer Pursuant to Securities Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
X
|
|
|
|
|
|
|
|
|
|
32.1* |
Certifications Pursuant to 18 U.S.C. Section 1350/ Securities Exchange Act Rule 13a-14(b), as adopted pursuant to Section 906 of the Sarbanes - Oxley Act of 2002 |
X
|
|
|
|
|
|
|
|
|
|
101.INS |
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
X |
|
|
|
|
|
|
|
|
|
101.SCH |
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
X |
|
|
|
|
|
|
|
|
|
104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
X |
|
|
|
* In accordance with Item 601(b)(32)(ii) of Regulation S‑K and SEC Release No. 34‑47986, the certifications furnished in Exhibits 31.1, 31.2 and 32.1 hereto are deemed to accompany this Form 10‑Q and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933 except to the extent that the Company specifically incorporates them by reference.
36
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
PLUS THERAPEUTICS, INC. |
||
|
|
|
|
|
|
|
By: |
|
/s/ Marc H. Hedrick |
Dated: May 15, 2026 |
|
|
|
Marc H. Hedrick |
|
|
|
|
President & Chief Executive Officer (Duly Authorized Officer and Principal Executive Officer) |
|
|
|
|
|
|
|
By: |
|
/s/ Andrew Sims |
Dated: May 15, 2026 |
|
|
|
Andrew Sims |
|
|
|
|
Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer and Principal Accounting Officer) |
37