PLUS THERAPEUTICS, INC.

Item 1A. Risk Factors

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

OShares of our common stock is s 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.

OAs 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 a mthe Minimum of $2.5 million in sStockholders eEquity Requirement for continued listing on The Nasdaq Capital Market or the Alternative Standards. The N

On September 5, 2024, Nasdaq notice states that our Annual Report on Form 10-K forfied 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 the fiscal yis determination to a Nasdaq Hear ended December 31, 2023, disclosedings Panel (the Panel), Nasdaq would move to suspend trading of our common stockholders equity and to have our shares of ($1.3 million) as of December 31, 2023, and that, as of common stock delisted from The Nasdaq Capital March 8, 2024, we did not meetket. We timely requested a hearing before the Alternative StandardsPanel, and the hearing was held on October 22, 2024.

On April 22October 30, 2024, we providreceived Nasdaq with our plan to achieve and sustaina decision from the Panel, notifying us that we had until March 4, 2025, to demonstrate compliance with the sMinimum Stockholders eEquity rRequirement and . The Panel also requesteired that Nasdaq grant us an extension of time until September 4, 2024, us to file a public disclosure on or before March 4, 2025 and describe the transactions undertaken by us to provide evidence ofachieve compliance and demonstrate long-term compliance with the sMinimum 

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Stockholders eEquity rRequirement. Nasdaq hasThe Panel also not yet responded to our plan, anded that it is a requirement during the exception period that we provide prompt notification to the Panel of any significant events that occur during there can be no assurance tis time that may affect our compliance with Nasdaqs requirements. This includes, but is not limited to, any event that Nasdaq will may call into question our ability to meet the terms of the exception grant an extension oed. The Panel reserved the right to reconsider that we will be able to comply with e terms of its decision based on any event, condition or circumstance that exists or develops that would, in the opinion of the applicable Panel, make continued listing standardof the Companys securities of n 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 sMinimum Stockholders eEquity rRequirement, or as a result of Nasdaq not granting us an extension or due to our 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 the Companysour 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. In the alternative, these Warrants mSee Note 12 (Stockholders Deficit - May 2024 Private Placement) for further details regarding the May not be exercised, in which event we are likely to 2024 Private Placement and the terms of the Warrants. 

In addition to the Warrants, we will seek alternativedditional sources of financing to continue the clinical development of our product candidates. Please see Note 12 for further information regarding the May 2024 Private Placement and the terms of the Warrants. 

In addition, outstandinOutstanding 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 may be 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:

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existing stockholders proportionate ownership interest in us will decrease;

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

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), a proprietary cell enumeration test 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 (186Re) 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.

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.

1188RNL-BAM will be regulated as a medical device, which may result in additional regulatory and other risks.

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188RNL-BAM was developed and tested preclinically as a drug product. The FDA has informed us that 188RNL-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 Federal Food, Drug, and Cosmetic Act (the FDCA)DCA, 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 188RNL-BAM, either as medical devices or as drugs, depending on each jurisdictions 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 188RNL-BAM, may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

Failure to successfully develop or supply the 188RNL-BAM medical device component, delays in or failure of the studies conducted by us, our collaborators, or third-party providers, or failure of our Companymanagement, our collaborators, or third-party providers to obtain or maintain regulatory approval or clearance of 188RNL-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 188RNL-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.

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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.