PLUS THERAPEUTICS INC

Current report

Item 1A. Risk Factors

Current report

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

Current report

In April 2024, we completed the acquisition of substantially all of the right, title and interest in CNSide (“CNSide”), a proprietary cell enumeration test 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.

Current report

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

Current report

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.

Current report

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”), 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.

Current report

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.

Current report

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.

Current report

Failure to successfully develop or supply the 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 Company, 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 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.

Previous report

k Factors

Previous report

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Previous report

2(a): Unregistered Sales of Equity Securities and Use of Proceeds

Previous report

None.

Previous report

2(b): Use of Proceeds from Registered Securities

Previous report

None.

Previous report

2(c): Purchases of Equity Securities

Previous report

The following table provides certain information with respect to the Company’s purchases of the Company’s common stock for the three months ended March 31, 2024:

Previous report

(1) On October 31, 2023, the Company announced that the Board authorized a $500,000 a share repurchase program (the “Share Repurchase Program”). Repurchases are funded from available cash and may be made at management’s discretion from time to time. As of March 31, 2024, there was no remaining amount available for future share repurchases under the Share Repurchase Program. The repurchase authorization will expire on October 31, 2024. Refer to Note 10. Stockholders’ Equity in Part I, Item 1 of this Quarterly Report on Form 10-Q for more information on the Share Repurchase Program.