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Item 1. Legal Proceedings

2025-05-30 compared with 2024-11-14 · 93 added, 76 removed, 26 unchanged (87% of the section changed)

1 unchanged sentence

Ris k Factors

We have been notified by Nasdaq of our failure to comply with the minimum stockholders’ equity continued listing requirement and, if we are unable to regain compliance with it or other applicable continued listing requirements and standards of Nasdaq, our common stock could be delisted from Nasdaq.

Shares of our common stocks are currently listed on The Nasdaq Capital Market.

In order to maintain that listing, we must satisfy continued listing requirements and standards.

There can be no assurances that we will be able to comply with the applicable listing standards of Nasdaq.

As previously disclosed, on March 8, 2024, we received the Notice from the Listing Qualifications staff of Nasdaq, notifying us that we no longer complied with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain the Minimum Stockholders’ Equity Requirement for continued listing on The Nasdaq Capital Market or the Alternative Standards.

On September 5, 2024, Nasdaq notified us that we had not regained compliance with Nasdaq Listing Rule 5550(b)(1) and that, as a result, unless we timely requested an appeal of this determination to a Nasdaq Hearings Panel (the “Panel”), Nasdaq would move to suspend trading of our common stock and to have our shares of common stock delisted from The Nasdaq Capital Market.

We timely requested a hearing before the Panel, and the hearing was held on October 22, 2024.

On October 30, 2024, we received a decision from the Panel, notifying us that we had until March 4, 2025, to demonstrate compliance with the Minimum Stockholders’ Equity Requirement.

The Panel also required that us to file a public disclosure on or before March 4, 2025 and describe the transactions undertaken by us to achieve compliance and demonstrate long-term compliance with the Minimum

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, 2024, which are incorporated herein by this reference, other than as set forth below.

The March 2025 Private Placement may result in an immediate trading halt or delisting of our shares of Common Stock from Nasdaq due to public interest concerns.

Under Nasdaq Listing Rule 5101, Nasdaq has broad discretionary authority to terminate the listing of securities, subject to a timely-requested hearing, if it determines that continued listing is not in the public interest, even if the issuer is in compliance with Nasdaq’s enumerated listing criteria.

The March 2025 Series A Warrants contain certain anti-dilution protection whereby, subject to certain exceptions, if the Company sells any shares of common stock (or securities convertible into or exercisable into common stock) at a price per share (or conversion or exercise price, as applicable) less than the exercise price of the March 2025 Series A Warrants then in effect, then the exercise price of the March 2025 Series A Warrants will be reduced to such lower price, but no lower than the Floor Price, and the number of shares issuable upon exercise will be proportionately adjusted such that the aggregate exercise price will remain unchanged.

The March 2025 Series A Warrants and March 2025 Series B Warrants contain exercise price reset and share combination event provisions that may result in a downward adjustment to the exercise price, subject to the Floor Price, and a corresponding increase in the number of shares of Common Stock issuable upon exercise therefor, such that the aggregate exercise price would remain unchanged.

The March 2025 Series B Warrants contain an alternative cashless exercise provision, pursuant to which the March 2025 Series B Warrants can be exercised without cash payment to the Company and for three (3) times the number of shares of Common Stock issuable upon exercise for cash of the March 2025 Series B Warrants.

As a result of such features, the number of shares of Common Stock issuable upon exercise of the March 2025 Series A Warrants and Series B warrants may increase significantly.

As of the date of filing of this quarterly report on Form 10-Q, the 28,042,138 March 2025 Series A Warrants issued in the March 2025 Private Placement is exercisable for an aggregate of up to 84,645,187 shares of Common Stock.

In addition, of the 28,042,138 March 2025 Series B Warrants issued in the March 2025 Private Placement, 2,248,080 warrants have been exercised into 16,257,428 shares of Common Stock, and the remaining March 2025 Series B Warrants is exercisable into 350,371,013 shares of Common Stock.

If Nasdaq determines the terms of the March 2025 Private Placement raised public interest concerns due to the dilutive nature of the transaction, or any other reason, Nasdaq may issue a determination letter to delist our shares of Common Stock pursuant to its discretionary authority under Listing Rule 5101.

In that event, even if we were to timely request a hearing with respect to Nasdaq’s determination to delist our shares of Common Stock, Nasdaq may still impose an immediate halt on the trading of our shares of Common Stock pursuant to Nasdaq Listing Rule 4120(a)(5) pending the outcome of such hearing.

If trading in our shares of Common Stock were to be halted or if Nasdaq were to determine to delist our shares of Common Stock, investors in our securities could lose all or part of their investment and our ability to raise additional capital through the public or private sale of equity securities would be adversely affected.

We could be delisted from Nasdaq for failure to comply with the Minimum Stockholders’ Equity Requirement, the Minimum Bid Requirement or other applicable continued listing requirements and standards of Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.

Our common stock is currently listed on The Nasdaq Capital Market.

In order to maintain that listing, we must maintain compliance with Nasdaq's continued listing requirements and standards.

There can be no assurances that we will be able to comply with the applicable listing requirements and standards of Nasdaq.

Minimum Stockholders’ Equity Requirement

In March 2024, we received notice from the Listing Qualifications staff of Nasdaq (the “Staff”), notifying us that we no longer maintained at least $2.5 million in stockholders’ equity, as required under Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”).

On September 5, 2024, Nasdaq notified us that we had not regained compliance with the Minimum Stockholders’ Equity Requirement and that, as a result, unless we timely requested an appeal of this determination to a Nasdaq Hearings Panel (the “Panel”), Nasdaq would move to suspend trading of our common stock and to have our shares of common stock delisted from The Nasdaq Capital Market.

The Company timely requested a hearing before the Panel, and the hearing was held on October 22, 2024.

On October 30, 2024, Nasdaq provided us until March 4, 2025, to notify Nasdaq that we were in compliance with the Minimum Stockholders’ Equity Requirement.

On March 7, 2025, the Company received notification from Nasdaq that it had regained compliance with the Minimum Stockholders’ Equity Requirement.

Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we will be subject to a Mandatory Panel Monitor until March 7, 2026.

If the Staff finds we are again out of compliance with the Minimum Stockholders’ Equity Requirement before that date, we will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and the Staff would not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor would we be afforded an applicable cure or compliance period.

Instead, the Staff would issue a “Delist Determination Letter” and we would have an opportunity to request a Nasdaq hearing panel regarding our continued listing.

As disclosed in this Quarterly Report, our stockholders’ equity as of March 31, 2025 was below the Minimum

Stockholders’ Equity Requirement.

The Panel also noted that it is a requirement during the exception period that we provide prompt notification to the Panel of any significant events that occur during this time that may affect our compliance with Nasdaq’s requirements.

This includes, but is not limited to, any event that may call into question our ability to meet the terms of the exception granted.

The Panel reserved the right to reconsider the terms of its decision based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s securities on The Nasdaq Capital Market inadvisable or unwarranted.

In the event that our common stock is delisted from Nasdaq, as a result of our failure to comply with the Minimum Stockholders’ Equity Requirement, or as a result of our failure to continue to comply with any other requirement for continued listing on Nasdaq, we may have to pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock,” which would make transactions in our common stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock.

This may also cause the market price of our common stock to decline.

We may issue additional shares of common stock or other equity securities without our stockholder approval, and holders of warrants and other securities convertible into shares of our common stock may choose to exercise their warrants and other securities requiring us to issue shares of common stock;

all of these actions would dilute your ownership interest and may depress the market price of our common stock.

In May 2024, we entered into a securities purchase agreement with certain investors, including certain of our directors and executive officers, and issued and sold in a private placement:

(i) an aggregate of 3,591,532 shares of common stock (or in lieu of shares of common stock, Pre-Funded Warrants), and (ii) Warrants to purchase up to 7,183,064 shares of common stock.

If these Warrants are exercised, it will result in significant dilution to our stockholders.

See Note 12 (Stockholders’ Deficit - May 2024 Private Placement) for further details regarding the May 2024 Private Placement and the terms of the Warrants.

In addition to the Warrants, we will seek additional sources of financing to continue the clinical development of our product candidates.

Outstanding securities convertible into our shares of common stock may also be exercised and restricted stock units may vest resulting in the issuance of additional shares of common stock, which will result in further dilution to our stockholders.

Significant additional capital will needed in the future to continue our planned operations, including further development of our product candidates, preparing IND or equivalent filings, conducting preclinical studies and clinical trials, commercialization efforts, expanded research and development activities and costs associated with operating a public company.

To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

If we sell common stock, convertible securities or other equity securities, investors may be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our shares of common stock.

We may also issue additional shares of common stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.

The issuance of additional shares or other equity securities of equal or senior rank would have the following effects:

• existing stockholders’ proportionate ownership interest in us will decrease;

• the relative voting strength of each previously outstanding common stock may be diminished;

• the market price of the common stock may decline.

We recently acquired the CNSide ® diagnostic portfolio, and we may not be successful in our efforts to develop, fully utilize and monetize it.

In April 2024, we completed the acquisition of substantially all of the right, title and interest in CNSide ® , including the CNSide Test , which is designed to detect, quantify, and monitor tumor status in LM.

We are currently evaluating and developing our business plan for developing the CNSide ® diagnostic portfolio alongside our lead radio therapeutic candidate, rhenium ( 186 Re) obisbemeda, and seeking partnering opportunities for CNSide ® but there can be no assurances that we will be able to develop the technology to allow for commercial applications, or successfully utilize and fully integrate CNSide ® into our operations.

We may not generate revenues from or realize the anticipated benefits of CNSide ® within our expected timeline or at all.

188 RNL-BAM will be regulated as a medical device, which may result in additional regulatory and other risks.

188 RNL-BAM was developed and tested preclinically as a drug product.

The FDA has informed us that 188 RNL-BAM will, moving forward, be regulated instead as a medical device.

In the United States, before we can market a new medical device, we must first receive either clearance under Section 510(k) of the FDCA, or approval of premarket approval (“PMA”), from the FDA, unless an exemption applies.

In the process of obtaining premarket clearance or approval following either of these routes, the FDA must determine that a proposed device is either substantially equivalent to a legally marketed predicate device with similar intended uses and the same technological characteristics and risks, or that it is safe and effective for its intended use, based, in part, on extensive data, including, but not limited to, technical, preclinical, clinical, manufacturing and labeling data.

The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life sustaining, life supporting or implantable devices.

Modifications to products that are approved through a PMA generally require FDA approval of the modifications through a supplemental application.

Both the PMA approval and the 510(k) clearance process can be expensive, lengthy and uncertain.

The process of obtaining a PMA is costly and uncertain and generally takes from one to three years, or even longer, from the time the application is submitted to the FDA.

In addition, a PMA generally requires the performance of one or more clinical studies.

Despite the time, effort and cost, a medical device may not be approved by the FDA.

Any delay or failure to obtain necessary regulatory approvals could harm our business.

Furthermore, even if we are granted regulatory approvals, they may include significant limitations on the approved and labeled indications for use for the device, which may limit the market for the device.

In addition, comparable foreign regulatory authorities to the FDA have approval policies and regulations related to the safety and performance requirements that apply to 188 RNL-BAM, either as medical devices or as drugs, depending on each jurisdiction’s regulatory requirements.

Accordingly, to the extent that we intend to sell medical devices in member states of the European Union or other foreign jurisdictions, the regulatory approval pathway for our product candidates, including 188 RNL-BAM, may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

Failure to successfully develop or supply the 188 RNL-BAM medical device component, delays in or failure of the studies conducted by us, our collaborators, or third-party providers, or failure of our management, our collaborators, or third-party providers to obtain or maintain regulatory approval or clearance of 188 RNL-BAM as a medical device or drug, as applicable in each jurisdiction, could result in increased development costs, delays in or failure to obtain regulatory approval, and associated delays in 188 RNL-BAM reaching the market.

Further, failure to successfully develop or supply the device, or to gain or maintain its approval, could adversely affect our operations.

Other than the risk factors set forth above, 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, 2023.

Other Inform ation

During the three months ended September 30, 2024, no ne of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Accordingly, we expect the Staff will issue a “Delist Determination Letter” and, once issued, we intend to request a hearing before a Nasdaq hearing panel regarding our continued listing with respect to the Minimum Stockholders’ Equity Requirement.

Minimum Bid Requirement

On May 16, 2025, we received notice from Nasdaq that, because the closing bid price for the our common stock has fallen below $1.00 per share for 30 consecutive business days, we no longer comply with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Requirement”).

Nasdaq’s notice has no immediate effect on the listing or trading of our common stock.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we are provided an initial compliance period of 180 calendar days, or until November 12, 2025, to regain compliance with the Minimum Bid Requirement.

To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to November 12, 2025.

If we do not achieve compliance with the Minimum Bid Requirement by November 12, 2025, we may be eligible for an additional 180 calendar days to regain compliance.

To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, with the exception of the Minimum Bid Requirement, and provide written notice of our intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split if necessary.

If the Nasdaq staff determines that we will not be able to cure the deficiency, or if we are otherwise not eligible for such additional compliance period, Nasdaq will provide notice that our common stock will be subject to delisting.

In the event we receive notice that our common stock is being delisted, Nasdaq rules permit us to appeal any delisting determination by the Nasdaq staff.

Furthermore, any efforts we take to meet the Minimum Bid Requirement, including pursuing a reverse stock split, may not be sufficient.

Potential Consequences of Delisting

There is no assurance that we will be able to meet Nasdaq’s listing requirements or comply with the requisite Nasdaq requirements to maintain our listing of common stock on Nasdaq.

In the event that our common stock is delisted from Nasdaq, as a result of our failure to comply with the Minimum Stockholders’ Equity Requirement or the Minimum Bid Requirement or as a result of our failure to continue to comply with any other requirement for continued listing on Nasdaq, and we are not able to list our securities on Nasdaq or any other national securities exchange, we could face significant material adverse consequences, including:

• a decline of the market price of our common stock;

• a limited availability of market quotations for our common stock;

• reduced liquidity for our common stock;

• a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

• a limited amount of news and analyst coverage for us;

• a decreased ability to issue additional securities or obtain additional financing in the future;

• the incurring of additional costs under state blue sky laws in connection with any sales of our securities.

As of the date of this Quarterly Report, we require additional funding to develop our product candidates, conduct future operations, and repay our outstanding debt obligations.

If we are unable to obtain the funds necessary to do so because our common stock is not listed on any national securities exchange, we may be required to delay, scale back or eliminate our product development activities, and we may be unable to continue our business operations.

If our common stock is delisted by Nasdaq, our common stock may be eligible to trade on an over-the-counter quotation system where an investor may find it more difficult to sell our stock or obtain accurate quotations as to the market value of our common stock.

In the event our common stock is delisted from Nasdaq, we may not be able to list our common stock on another national securities exchange or obtain quotation on an over-the-counter quotation system.

Unregistered Sal es of Equity Securities and Use of Proceeds

Unregistered Sales of Equity Securities and Use of Proceeds

Information required by Item 701 of Regulation S-K as to all unregistered sales of equity securities of the Company during the period covered by this Quarterly Report has previously been included in Current Reports on Form 8-K filed with the SEC.

Use of Proceeds from Registered Securities

Purchases of Equity Securities

EXHIBIT INDEX

4 unchanged sentences

Incorporated by Reference

Composite Certificate of Incorporation of Plus Therapeutics, Inc.

Certificate of Amendment to Amended and Restated Certificate of Plus Therapeutics, Inc.

Composite Certificate of Incorporation

Certificate of Amendment to Amended and Restated Certificate

Certificate of Amendment to the Certificate of Incorporation, as amended

Amended and Restated Bylaws of Plus Therapeutics, Inc.

1 unchanged sentence

Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock

Certification of Elimination of the Series F Preferred Stock of Plus Therapeutics, Inc .

Form of Underwriters’ Warrant Amendment Agreement

Certificate of Designation of Series F Preferred Stock, dated March 3, 2023

Description of Securities

Form of Common Stock Certificate

Form of Pre-Funded Warrant

Form of Series A Warrant (May 2024, as amended and restated August 2024)

Form of Series B Warrant (May 2024, as amended and restated August 2024)

Form of Amendment and Restatement of the Plus Therapeutics, Inc.

Series A Common Stock Purchase Warrant

Form of Amendment and Restatement of the Plus Therapeutics, Inc.

Series B Common Stock Purchase Warrant

Form of Series A Warrant (as amended and restated August 2024)

Form of Series B Warrant (as amended and restated August 2024)

Form of Amendment and Restatement of the May 2024 Series A Warrant

Form of Amendment and Restatement of the May 2024 Series B Warrant

Form of Pre-Funded Warrant

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

Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc.

and the purchasers named therein

Form of Secured Convertible Note for Funding Notes issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc.

and the purchasers names therein

Form of Secured Convertible Note for Exchange Notes issued pursuant to the Securities Purchase and Exchange Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc.

and the purchasers names therein

Security Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc., CNSide Diagnostics, LLC and Iroqouis Master Fund Ltd., as collateral agent for the purchasers names therein

Subsidiary Guarantee, dated as of February 13, 2025, by and among CNSide Diagnostics, LLC and the purchasers named therein

Registration Rights Agreement, dated February 13, 2025, by and among Plus Therapeutics, Inc.

and the purchasers named therein

Second Amendment to Securities Purchase Agreement, dated May 5, 2024, as amended on May 9, 2024, by and among Plus Therapeutics, Inc.

and the purchasers named therein

Securities Purchase Agreement, dated as of March 4, 2025

Registration Rights Agreement, dated as of March 4, 2025

First Amendment to Securities Purchase and Exchange Agreement, dated as of March 4, 2025

Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

3 unchanged sentences

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

Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents

Inline XBRL Taxonomy Extension Calculation Linkbase Document

Inline XBRL Taxonomy Extension Definition Linkbase Document

Inline XBRL Taxonomy Extension Label Linkbase Document

Inline XBRL Taxonomy Extension Presentation Linkbase Document

Inline XBRL Schema Document

Inline XBRL Calculation Linkbase Document

Inline XBRL Definition Linkbase Document

Inline XBRL Label Linkbase Document

Inline XBRL Presentation Linkbase Document

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

3 unchanged sentences

PLUS THERAPEUTICS, INC.

November 14, 2024

President & Chief Executive Officer (Duly Authorized Officer and Principal Executive Officer)

/s/ Andrew Sims

November 14, 2024

Chief Financial Officer (Duly Authorized Officer and Principal Financial Officer and Principal Accounting Officer)

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Legal Proceedings