Perspective Therapeutics, Inc. (CATX) Risk Factors

Verbatim Item 1A Risk Factors from Perspective Therapeutics, Inc.'s latest 10-K. Filing date: 2026-03-16. Accession: 0000728387-26-000004.

This page reproduces the company's own Item 1A Risk Factors text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.

Informational only - not investment advice. See Disclaimer.

Extracted from Item 1A Risk Factors to the first Item 1B/1C/2 boundary after HTML sanitization. Confidence: high. Source form: 10-K. Character span: 210810-381179.

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ITEM 1A – RISK FACTORS

Our business is subject to substantial risks and uncertainties. The occurrence of any of the following risks and uncertainties, either alone or taken together, could materially and adversely affect our business, financial condition, results of operations or prospects. In these circumstances, the market price of our common shares could decline, and you may lose all or part of your investment. The risks and uncertainties described below are not the only ones we face. Risks and uncertainties of general applicability and additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business, financial condition, results of operations or prospects.

Risks Related to Our Business, Financial Results and Need for Additional Capital

We are a clinical-stage biopharmaceutical company and have a limited operating history upon which to base an investment decision. Since the merger of Isoray and Viewpoint in 2023, we have engaged primarily in research and development activities related to VMT-α-NET, VMT01, PSV359 and our other programs, have not generated any revenue from product sales other than our discontinued brachytherapy business and have incurred significant net losses. We have not received regulatory approval to market any of our current product candidates.

The successful commercialization of any of our product candidates will require us to perform a variety of functions, including:

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completing preclinical development and clinical trials;

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obtaining regulatory and marketing approval;

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manufacturing products in compliance with applicable federal, state and local regulations and maintaining supply and manufacturing relationships with third parties that are both commercially feasible and meet regulatory requirements and our supply needs in sufficient quantities to meet market demand for product candidates, if approved;

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conducting sales and marketing activities;

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negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;

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obtaining reimbursement or pricing for our product candidates that supports profitability; and

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managing our spending and cash requirements as our expenses are expected to continue to increase as we continue to invest in the development of our product candidates and other radiopharmaceutical programs, expand our manufacturing capabilities and undertake commercialization activities.

Our operations since the merger of Isoray and Viewpoint in 2023 have been limited to organizing and staffing, acquiring, developing and securing the proprietary rights for, and undertaking preclinical development and clinical trials for VMT-α-NET, VMT01, PSV359 and our other programs. These operations provide a limited basis for our stockholders and prospective investors to assess our ability to complete development of or commercialize VMT-α-NET, VMT01, PSV359 or any of our other programs given the risks and uncertainties frequently encountered in new and rapidly evolving fields and the advisability of investing in our securities.

Even if one or more of our product candidates is approved for marketing, we anticipate incurring significant costs associated with commercialization of such product candidate(s). Portions of our current pipeline of product candidates have been in-licensed from third parties, which makes the commercial sale of such in-licensed products potentially subject to additional royalty and milestone payments to such third parties. We will also have to continue to expand our manufacturing capabilities to support expanded manufacturing, development and potential commercialization of our product candidates. Additionally, if we are not able to gain market acceptance for our product candidates, or if the market is too small or competitive to generate revenue from the sale of any approved products, we may never become profitable.

We will require substantial additional capital to fund our operations. Additional funds may be dilutive to shareholders or impose operational restrictions. Further, if additional capital is not available, we may need to delay, limit or eliminate our research, development and commercialization programs and modify our business strategy. Our principal sources of liquidity are cash, cash equivalents and short-term investments, which were $144.7 million as of December 31, 2025. In February 2026, we announced the closing of an underwritten offering of securities with gross proceeds of $175.0 million before deducting underwriting discounts and commissions and other offering-related expenses. We believe that our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current clinical milestones and operational investments into late 2027. However, changing circumstances may cause us to consume capital faster than we currently anticipate. Within the next several years, substantial additional funds will be required to continue with the active development of our clinical programs as well as the other preclinical programs and technologies in our pipeline.

In particular, our funding needs may vary depending on a number of factors including:

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the extent to which we continue the development of our product candidates or form licensing arrangements to advance our product candidates;

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the expansion of our manufacturing capabilities and the costs and timing associated therewith;

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our decisions to in-license or acquire additional programs, additional product candidates or technology for development;

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our ability to attract and retain development or commercialization partners, and their effectiveness in carrying out the development and ultimate commercialization of one or more of our product candidates;

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whether batches of product candidates that we manufacture fail to meet specifications resulting in clinical trial delays and investigational and remanufacturing costs;

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the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology, product candidates and other programs;

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competing programs, product candidates and technological and market developments; and

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prosecuting and enforcing our patent claims and other intellectual property rights.

We will seek to obtain funding to maintain and advance our business from a variety of sources including equity financings, debt financings, licensing agreements, partnerships, government grants and contracts, and other strategic transactions and funding opportunities. There can be no assurance that we will be able to complete any such transaction on acceptable terms or otherwise.

If we are able to raise additional capital through the issuance of equity securities, the percentage ownership of our current shareholders will be reduced. In addition, we may issue equity as part of the consideration to our licensors, to compensate consultants or to settle outstanding payables, all of which could cause our shareholders to experience additional dilution in net book value per share. Holders of any such additional equity securities may have rights, preferences and privileges senior to those of the holders of our common shares.

Debt financing, if available, will result in payment obligations and 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. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our existing shareholders. If we raise additional funds through corporate collaborations, partnerships or other strategic transactions, it may be necessary for us to relinquish valuable rights to our product candidates or other programs, our technologies or future revenue streams or to grant licenses or sell assets on terms that may not be favorable to us.

If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will need to curtail and reduce our operations and costs, and modify our business strategy which may require us to, among other things:

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significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or other programs or one or more of our research and development initiatives;

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seek collaborators for one or more of our product candidates or other programs or one or more of our research and development initiatives at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;

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sell or license on unfavorable terms our rights to one or more of our technologies, product candidates or other programs or research and development initiatives that we otherwise would seek to develop or commercialize ourselves;

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rely on federal funding opportunities; or

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cease operations.

We have incurred losses in nearly every year since our inception, and we anticipate that we will not achieve profits for the foreseeable future. To date, we have incurred losses nearly every year since inception through the year ended December 31, 2025 and have not generated any revenues other than from our brachytherapy business, which was divested in April 2024. From inception to December 31, 2025, we have an accumulated deficit of approximately $334.8 million. Investment in drug development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. We continue to incur significant research, development and other expenses related to our ongoing operations, including development of our product candidates. We do not expect to achieve profits until such time as product sales, milestone payments and royalty payments, if any, generate sufficient revenues to fund our continuing operations. We cannot predict if we will ever achieve profitability and, if we do, we may not be able to remain consistently profitable or increase our profitability.

We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will continue to be significant if and as we:

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continue our research and preclinical and clinical development of our product candidates and other programs;

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initiate additional preclinical, clinical or other studies or trials for our product candidates and other programs;

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continue or expand our licensing arrangements with our licensing partners;

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change or add additional manufacturers or suppliers;

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seek regulatory approvals for our product candidates that successfully complete clinical trials;

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establish a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory approval;

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seek to identify and validate additional product candidates;

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acquire or in-license other product candidates and technologies;

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maintain, protect and expand our intellectual property portfolio;

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attract and retain skilled personnel;

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create additional infrastructure to support our research, product development, manufacturing and planned future commercialization efforts; and

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experience any delays or encounter issues with any of the above.

The net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparisons of our results of operations may not be a good indication of our future performance.

Risks Related to Our Business and Industry

Our product candidates are in early stages of development and must go through clinical trials, which are very expensive, time consuming and difficult to design and implement. The outcomes of clinical trials are uncertain, and delays in the completion or termination of any clinical trial of our product candidates could harm our business, financial condition and prospects. Our research and development programs are at an early stage of development. We must demonstrate our product candidates’ safety and efficacy in humans through extensive clinical testing, which is expensive and time consuming and requires specialized knowledge and expertise. Clinical trials are also expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming, and the outcome is not certain. We estimate that clinical trials of our product candidates will take multiple years to complete. Failure can occur at any stage of a clinical trial, and we could encounter problems that cause us to abandon or repeat clinical trials.

Clinical trials of our product candidates in the United States must be performed under an Investigational New Drug (IND) application authorized by the United States Food and Drug Administration (FDA). The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the program. Though animal studies remain a common part of nonclinical development, the FDA has recently announced a shift away from animal testing and greater reliance on artificial intelligence (AI)-based computational modeling. In April 2025, the FDA published a roadmap outlining its strategy to reduce animal testing in preclinical safety studies through the use of alternative methodologies, and, in December 2025, issued draft guidance providing streamlined nonclinical safety study recommendations for monospecific monoclonal antibodies, including the potential elimination or reduction of long-term non-human primate toxicology studies. These developments, if finalized, could affect the design and timeline of our nonclinical development programs, and we continue to monitor FDA guidance in this area as it evolves.

An IND must become effective before human clinical trials may begin. Clinical trials involve the administration of an investigational program to human subjects under the supervision of qualified investigators in accordance with good clinical practices (GCPs), which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during program development and for any subsequent protocol amendments. Furthermore, an independent institutional review board (IRB) for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site and must monitor the study until completed. Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries.

We currently have three clinical trials in Phase 1/2a for VMT-α-NET, VMT01 and PSV359. All three trials are registered with ClinicalTrials.gov. We have completed dosing our initial cohorts for each of these trials and are currently enrolling patients in additional cohorts. VMT-α-NET and VMT01 have also received Fast Track designation, which allows for rapid communication with the FDA on clinical trial development plans and findings. The approved Phase 1/2a trial for VMT-α-NET is entitled “A Phase 1/2a First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors.” The approved Phase 1/2a trial for VMT01 is entitled “A Phase 1/2a, First-In-Human, Multi-Center Dose Escalation and Dose Expansion Study of [203/212Pb]VMT01 Receptor-Targeted, Image Guided Alpha-Particle Therapy in Patients with Previously Treated Unresectable or Metastatic Melanoma.” The approved Phase 1/2a study for PSV359 is entitled “A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients with Solid Tumors that are Known to be Fibroblast Activation Protein (FAP)-Positive.” All three trials are multi-center.

As with most pharmaceutical products, use of our product candidates could be associated with side effects or adverse events, which can vary in severity and frequency. Side effects or adverse events associated with the use of our product candidates may be observed at any time, including in clinical trials or when a product is commercialized. Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other foreign authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects, toxicity or other safety issues, and could require us to perform additional studies or halt development or sale of these product candidates or expose us to product liability lawsuits that will harm our business. In such an event, we may be required by regulatory agencies to conduct additional animal or human studies regarding the safety and efficacy of our product candidates that we have not planned or anticipated, or our studies could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. There can be no assurance that we will resolve any issues related to any product-related adverse events to the satisfaction of the FDA or any other regulatory agency in a timely manner, if ever, which could harm our business, prospects and financial condition.

We rely on single vendors to provide supplies and services used in the development and production of our alpha-particle therapies. We obtain nearly all our supply of Thorium-228 (a precursor to 212Pb) from a single supplier, the U.S. Department of Energy (DOE). In January 2021, we entered into a 10-year contract with the DOE for the purchase of Thorium-228. In May 2025, we entered into a supply agreement with the DOE under which we will purchase Thorium-228 from the DOE during 2025 and early 2026. The supply agreement includes a “take-or-pay” provision pursuant to which we are committed to purchasing approximately $8.4 million of Thorium-228 during the term of the agreement. From time to time, we may enter into additional supply agreements with the DOE for the purchase of Thorium-228. Additionally, we currently utilize one vendor for the manufacture of resin chromatography columns that are used in our 212Pb generators. We also rely on a single vendor to assemble and load isotopes into the generators that are used to extract 212Pb for use in the doses for our clinical trials. Reliance on any single supplier or vendor increases the risks associated with obtaining raw materials and necessary services. Should the agreement with the DOE be cancelled or terminated for any reason, we may be unable to obtain an alternative supply of Thorium-228 at a comparable cost, which may have a material adverse impact on our ability to further develop or produce our alpha-particle therapies. Should the agreement with the vendor that manufactures resin chromatography columns that are used in our generators or the agreement with the vendor that assembles and loads isotopes in our generators be cancelled or terminated for any reason, or should either such vendor fail to perform adequately under its agreement with us, our ability to produce doses for our clinical trials may be materially delayed or impaired.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients depends on many factors, including:

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the patient eligibility criteria defined in the protocol;

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the size of the patient population;

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the suitability and location of clinical trial sites;

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the proximity and availability of clinical trial sites for prospective patients;

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the design of the trial;

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our ability to recruit clinical trial investigators with the appropriate competencies and experience;

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our ability to obtain and maintain patient consents; and

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the risk that patients enrolled in clinical trials will drop out of the trials before completion, including as a result of changing standards of care or the ineligibility of a site to participate.

Our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates. This competition will reduce the number and types of patients and qualified clinical investigators available to us because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors, or clinical trial sites may not allow us to conduct our clinical trial at such site if competing trials are already being conducted there. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial sites. We may also encounter difficulties finding suitable clinical trial sites at which to conduct our trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates and may result in additional net losses.

Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval. Pharmaceutical development has inherent risk. We will be required to demonstrate through well-controlled clinical trials that our product candidates are effective with a favorable benefit-risk profile for use in their target indications before we can seek regulatory approvals for their commercial sale. Success in preclinical studies or early clinical trials does not mean that later clinical trials will be successful, as product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing, and clinical data are often susceptible to varying interpretations or analyses. We also may need to conduct additional clinical trials that are not currently anticipated. Companies frequently suffer significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results.

We periodically publish or report interim or preliminary data from our ongoing clinical trials including unconfirmed responses as part of our development updates or investor communications. Interim or preliminary data are, by their nature, based on a subset of patient data and may not be indicative of the final results of the trial. As patient enrollment continues and additional data becomes available, one or more clinical outcomes, including response rates, durability of response and safety findings, may change materially, including due to differences in the characteristics of patients included in each data set and read-out. All interim or preliminary data remain subject to audit and verification procedures, and final data may differ materially from previously reported interim results. As a result, interim or preliminary data should be viewed with caution until the final data are available.

Delays in the commencement, execution or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our product candidates. Although our Phase 1/2a clinical trials are ongoing, the completion of clinical trials can be delayed for a variety of reasons, including:

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delay or failure in reaching agreement with the FDA or other regulatory authority outside the United States on the design of a given trial, or in obtaining authorization to commence or continue a trial;

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failure to generate satisfactory preclinical, toxicology, or other in vivo or in vitro data or diagnostics to support the initiation or continuation of our clinical trials;

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identifying, recruiting and training suitable clinical investigators;

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reaching agreement on acceptable terms with prospective clinical research organizations (CROs) and trial sites, the terms of which can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;

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obtaining sufficient quantities of investigational product for our product candidates for use in clinical trials;

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obtaining IRB or ethics committee approval to conduct a clinical trial at a prospective site;

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identifying, recruiting and enrolling suitable patients to participate in a clinical trial, including delays and/or interruptions resulting from geopolitical actions, disease or public health epidemics, or natural disasters;

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retaining patients who have initiated a clinical trial but may withdraw due to adverse events from the therapy, insufficient efficacy, fatigue with the clinical trial process or personal issues;

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changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;

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inability to identify and maintain a sufficient number of suitable trial sites;

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failure of CROs to meet their contractual obligations or deadlines;

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the need to modify a trial protocol;

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unforeseen safety issues;

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emergence of dosing issues;

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lack of effectiveness data during clinical trials;

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changes in the standard of care of the indication being studied;

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reliance on third-party suppliers relating to the clinical trial supply of product candidates and failure by our third-party suppliers to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

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inability to monitor subjects adequately during or after treatment;

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limitations on our or our CROs’ ability to access and verify clinical trial data captured at clinical trial sites through monitoring and source document verification;

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changes in governmental regulations or administrative action; and

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availability of funds.

Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our product candidates. In addition, many of the factors that cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.

We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed. Regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Clinical trials must be conducted in accordance with current Good Clinical Practices (CGMPs) or other applicable foreign government guidelines governing the design, safety monitoring, quality assurance and ethical considerations associated with clinical studies. Clinical trials are subject to oversight by the FDA, other foreign governmental agencies and IRBs at the study sites where the clinical trials are conducted. In addition, clinical trials must be conducted with product candidates produced in accordance with applicable CGMPs, which are the FDA’s regulations governing the design, monitoring and control of manufacturing processes and facilities. In the EU, clinical trials should be conducted in accordance with guidelines on good clinical practices and in accordance with the Clinical Trials Regulation. Under the Clinical Trials Regulation, sponsors must submit one application for a new trial to the online Clinical Trials Information System for approval to run a trial in several European countries. Prior to authorization, the clinical trial shall be subject to ethics review performed by an ethics committee, in accordance with the law of the concerned EU member state.

Clinical trials may be suspended by the FDA, other foreign governmental agencies or us for various reasons, including:

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deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;

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deficiencies in the clinical trial operations or trial sites;

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the product candidate may have unforeseen adverse side effects;

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deficiencies in the trial design necessary to demonstrate efficacy;

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fatalities or other adverse events arising during a clinical trial due to medical problems that may not be related to clinical trial treatments;

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the product candidate may not appear to be more effective than current therapies; or

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the quality or stability of the product candidate may fall below acceptable standards.

If we elect or are forced to suspend or terminate a clinical trial for VMT-α-NET, VMT01, PSV359 or of any other product candidates, the commercial prospects for that product candidate will be harmed and our ability to generate product revenue from that product candidate may be delayed or eliminated. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these product candidates, either by us or by our collaboration partners.

The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable; if we experience unanticipated delays or are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions, and our business will be substantially harmed. The time required to obtain approval by the FDA in the United States and by comparable health authorities in foreign markets, including Health Canada’s Therapeutic Products Directorate (Health Canada), the European Medicines Agency (EMA) and the European Commission (EC), is unpredictable but typically takes many years from the initiation of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the programs involved and the discretion of the regulatory authorities. Our ability to obtain marketing approval for our product candidates depends on generating sufficient clinical and nonclinical data, including adequate characterization and control of manufacturing processes and validation activities, that meet applicable regulatory standards. We have not submitted an NDA, a marketing application or a similar filing to obtain regulatory approval for any product candidate in any jurisdiction, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.

The FDA, Health Canada, the EMA and, where applicable, the EC, can delay, limit or deny approval of VMT-α-NET, VMT01, PSV359 and our other product candidates for many reasons, including any one or more of the following:

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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

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we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

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the results of clinical trials may not demonstrate statistically robust and/or clinically meaningful results sufficient to support approval;

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we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

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the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

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the data collected from clinical trials of our product candidates may not be sufficient to support an NDA, a marketing application or any other submission to obtain regulatory approval in the United States or elsewhere;

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the FDA or comparable foreign regulatory authorities may require additional data or impose conditions that differ from prior guidance or interactions;

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the FDA or comparable foreign regulatory authorities may fail to approve our manufacturing processes or facilities or the manufacturing processes and facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

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the FDA or comparable foreign regulatory authorities may fail to approve our product candidates;

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the FDA or comparable regulatory authorities may find that our manufacturing process(es) and or data integrity systems are inadequate during pre-approval inspection and/or routine inspection; and

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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

The time and expense of the approval process, as well as the unpredictability of clinical trial results and other contributing factors, may result in our failure to obtain regulatory approval to market, in one or more jurisdictions, VMT-α-NET, VMT01, PSV359 or future product candidates, which would significantly harm our business, results of operations and prospects.

Disruptions at the FDA, including a lapse in appropriations and/or decreased funding for the FDA, could prevent the FDA from performing functions on which our business relies, which could negatively impact our business. The ability of the FDA to review and approve new products or review other regulatory submissions can be affected by a variety of factors, including statutory, regulatory and policy changes; budget and funding levels; workforce reductions; and the FDA’s ability to hire and retain qualified personnel. Such disruptions may increase the time to meet with the FDA, receive FDA feedback, obtain review and/or approve our submissions, conduct inspections, issue regulatory guidance, or take other actions that facilitate the development, approval and marketing of regulated products, which could adversely affect our business. Government proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and related agencies. Budgetary pressures, workforce reductions, or changes in agency priorities may impair, delay or reduce the FDA’s ability to perform its responsibilities. If the FDA experiences a material reduction in its budget or a prolonged government shutdown, the agency’s ability to timely review and process our regulatory submissions, conduct inspections, or take other actions critical to the development or marketing of our product candidates could be significantly impaired, which could have a material adverse effect on our business. We are unable to predict the nature, timing or extent of any such disruptions or their ultimate impact on the FDA’s operations and our programs.

We receive federal funding to conduct certain research on our product candidates and other programs, and recent federal policy changes could disrupt that funding. Our business has relied on grants from agencies such as the National Institutes of Health (NIH) as well as funding provided to academic research institutions and clinical trial sites that conduct studies on our product candidates and other programs. The current presidential administration has proposed and implemented budget cuts to key federal health agencies, including NIH and the FDA, which may reduce the availability of research grants and clinical trial support. Additionally, shifting priorities in federal research funding, such as an increased emphasis on certain therapeutic areas (e.g., chronic conditions versus infectious diseases) or a move toward industry partnerships over direct grant funding, could reduce the likelihood that our research and clinical programs continue to receive government support. If these policy shifts lead to a reduction or elimination of funding for our programs or our clinical trial partners, we may need to seek alternative financing sources, which could be costly or unavailable. Any reduction in federal funding could materially impact our ability to advance our pipeline and bring new therapies to market.

We intend to rely on third-party collaborators to market and sell our programs, and those third-party collaborators may not have the resources to pursue approvals, which in turn could severely limit our potential markets and ability to generate revenue. In order to market and sell our programs in any jurisdiction, we or our third-party collaborators must obtain separate marketing approvals in that jurisdiction and comply with its regulatory requirements. The approval procedure can vary drastically among countries, and each jurisdiction may impose different testing and other requirements to obtain and maintain marketing approval. Further, the time required to obtain those approvals may differ substantially among jurisdictions. Approval by the FDA or an equivalent foreign authority does not ensure approval by regulatory authorities in any other countries or jurisdictions. As a result, the ability to market and sell a product candidate in more than one jurisdiction can involve significant additional time, expense and effort to undertake separate approval processes, and could subject us and our collaborators to the numerous and varying post-approval requirements of each jurisdiction governing commercial sales, manufacturing, pricing and distribution of VMT-α-NET, VMT01, PSV359 and our other product candidates. We or any third parties with whom we may collaborate may not have the resources to pursue those approvals, and we or they may not be able to obtain any approvals that are pursued. The failure to obtain marketing approval for VMT-α-NET, VMT01, PSV359 and our other product candidates in foreign jurisdictions could severely limit our potential markets and our ability to generate revenue.

In addition, even if we were to obtain regulatory approval in one or more jurisdictions, regulatory authorities may approve VMT-α-NET, VMT01, PSV359 and our other product candidates for fewer or more limited indications than we request, may not approve the prices we may propose to charge for our programs, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with labeling that does not include the claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing circumstances could materially harm the commercial prospects for VMT-α-NET, VMT01, PSV359 and our other product candidates.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of the approved labeling, or result in significant negative consequences following marketing approval, if any. Results of current and future clinical trials of VMT-α-NET, VMT01, PSV359 and our other product candidates could reveal a high and/or unacceptable severity and frequency of these adverse effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Further, any observed drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. This, in turn, could prevent us from commercializing the affected product candidate and generating revenues from our sales. We have not yet completed testing of any of our product candidates for the treatment of the indications for which we intend to seek product approval in humans, and we currently do not know the extent of adverse events, if any, that will be observed in patients who receive any of our product candidates. If any of our product candidates cause unacceptable adverse events in clinical trials resulting in a clinical hold, we cannot give any assurance that we will be able to resolve any future clinical holds imposed by the FDA or other regulatory authorities outside of the United States on a timely basis or at all.

Additionally, if VMT-α-NET, VMT01, PSV359 and our other product candidates receive marketing approval, and we or others later identify undesirable side effects caused by our product candidates, a number of potentially significant negative consequences could result, including:

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regulatory authorities may withdraw approvals of such program;

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regulatory authorities may require additional warnings in the program’s labeling;

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we may be required to create a medication guide for distribution to patients in the U.S., or an equivalent document in other jurisdictions, that outlines the risks of such side effects;

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we could be sued and held liable for harm caused to patients; and

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our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular program, if approved, and could significantly harm our business, results of operations and prospects.

If we are unable to execute our sales and marketing strategy for our product candidates, if commercialized, and are unable to gain market acceptance, we may be unable to generate sufficient revenue to sustain our business. We are a clinical-stage biopharmaceutical company and have yet to begin to generate revenue from VMT-α-NET, VMT01, PSV359 and other product candidates. Our product candidates are in an early stage of clinical development, and, if we obtain marketing approval for any of our programs in the future, we anticipate this would not occur for several years, if at all.

Although we believe that VMT-α-NET, VMT01 and PSV359 represent promising commercial opportunities, they may never gain significant market acceptance and therefore may never generate substantial revenue or profits for us. We will need to establish a market for VMT-α-NET, VMT01, PSV359 and our other product candidates and build that market through physician education, awareness programs and the publication of clinical data. Gaining acceptance in medical communities requires, among other things, publication in leading peer-reviewed journals of results from our studies. The process of publication in leading medical journals is subject to a peer review process, and peer reviewers may not consider the results of our studies sufficiently novel or worthy of publication. Failure to have our studies published in peer-reviewed journals could limit the adoption of VMT-α-NET, VMT01, PSV359 or our other product candidates. Our ability to successfully market our product candidates that we may develop will depend on numerous factors, including:

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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

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the inability to demonstrate that the clinical and other benefits of a product candidate outweigh any safety or other perceived risks;

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conducting clinical utility studies of our product candidates to demonstrate economic usefulness to providers and payors;

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whether our current or future partners support our offerings;

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the success of the sales force and marketing efforts;

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whether healthcare providers believe our product candidates provide clinical utility; and

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whether private health insurers, government health programs and other third-party payors will cover our product candidates.

Because we license technology underlying some of our product candidates from third parties, any dispute with our licensors or non-performance by us or by our licensors may adversely affect our ability to develop and commercialize the applicable product candidates. The intellectual property rights underlying several of our product candidates were licensed from third parties. Under the terms of our license agreements, the licensors generally have the right to terminate such agreements in the event of a material breach by us. Our licenses generally require us to make annual, milestone or other payments prior to commercialization of any program, and our ability to make these payments depends on our ability to generate cash in the future. These agreements generally require us to use diligent and reasonable efforts to develop and commercialize the applicable product candidate.

If there is any conflict, dispute, disagreement or issue of nonperformance between us and our licensing partner regarding our rights or obligations under the license or other agreements, including any conflict, dispute or disagreement arising from our failure to satisfy payment obligations under such agreement or question as to which party owns newly developed product(s), our ability to develop and commercialize the affected product candidate may be adversely affected. Any loss of our rights under our license agreements could delay or completely terminate our program development efforts for the affected product candidate, and we may not obtain the revenues anticipated.

We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements. From time to time, we may form or seek strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to VMT-α-NET, VMT01, PSV359 and any future product candidates that we may develop. Any of these relationships may require us to incur nonrecurring and other charges, increase our near and long-term expenditures, or disrupt our management and business. These relationships also may result in a delay in the development of VMT-α-NET, VMT01, PSV359 and our other product candidates if we become dependent upon the other party and such other party does not prioritize the development of our product candidates relative to our other development activities. In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process may be time consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort, and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. If we license programs or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture. We cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that justifies such transaction. We rely on third parties to manufacture our preclinical and clinical pharmaceutical supplies and expect to continue to rely on third parties relating to the production of commercial supplies of our product candidates, and our dependence on third-party suppliers could adversely impact our business.

We may rely partially on third parties to manufacture our clinical pharmaceutical supplies and could continue to rely on third parties to produce commercial supplies of any approved product candidate, and our dependence on third-party suppliers could adversely impact our business. We may not have the resources or capacity to commercially manufacture any of our proposed programs, if approved, and may be dependent upon third-party manufacturers. Our potential reliance on third-party manufacturers may expose us to risks, such as difficulties in manufacturing or obtaining from third parties sufficient quantities of a product candidate for use in clinical trials or commercial use that meet internal and regulatory standards. Our possible dependence on third parties to manufacture and supply us with materials for clinical trials and any approved products may adversely affect our ability to develop and commercialize our programs on a timely basis or at all.

We may not be successful in managing the build-out of our manufacturing facilities and associated costs or satisfying manufacturing-related regulatory requirements. We have been investing in our manufacturing capabilities and have acquired several manufacturing facilities. In March 2024, we acquired the assets and associated lease of Lantheus Holdings, Inc.’s radiopharmaceutical manufacturing facility in Somerset, NJ. This site has three production suites that Perspective intends to utilize to supply drug product for the northeastern half of the United States. In July 2024, August 2024, and October 2024, we purchased a building in the Houston, TX, metropolitan area for $4.7 million, a building in the Chicago, IL, metropolitan area for $5.0 million, and a building in the Los Angeles, CA, metropolitan area for $11.0 million, respectively, which we intend to use to manufacture our product candidates upon completion of modifications and installation of equipment. The build-out of these facilities and related equipment purchases are complex and specialized and involve substantial capital expenditures, and it could take longer, and cost more, than currently expected. Significant delays and/or cost overruns could result in higher expenditures and could be disruptive to operations, any of which could have a negative impact on our financial conditions or results of operations.

We also may not successfully realize the anticipated benefits from the capital expenditure at such facilities based on factors such as delays and uncertainties regarding development, regulatory approval and commercialization of our product candidates, as well as the potential to lose access to any leased facilities. Moreover, any production shortfall that impairs the supply of our product candidates could negatively impact our ability to complete clinical trials, obtain regulatory approvals and commercialize our product candidates. A product shortfall could have a material adverse effect on our business, financial condition and results of operations.

In addition, our operations, including our development, testing and future manufacturing activities, are subject to numerous environmental, health, and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of and the maintenance of a registry for, hazardous materials and biological materials, such as chemical solvents, carcinogenic compounds, mutagenic compounds and compounds that may have a toxic effect on reproduction and laboratory procedures. If we fail to comply with such laws and regulations, we could be subject to fines or other sanctions. Failure to successfully complete our build-outs and successfully operate our planned manufacturing facilities and satisfy manufacturing-related regulatory requirements could adversely affect the commercial viability of our product candidates and our business.

We rely on third parties to conduct our clinical trials, and if these third parties do not meet their deadlines or otherwise conduct the trials as required, our clinical development programs could be delayed or unsuccessful, and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected or at all. We do not have the ability to conduct all aspects of our preclinical testing or clinical trials themselves. We use CROs in our clinical trials and expect to rely upon CROs, as well as medical institutions, clinical investigators, and consultants, to help conduct our trials in accordance with our clinical protocols pursuant to contracts with such entities. Our CROs, investigators and other third parties play a significant role in the conduct of these trials and the subsequent collection and analysis of data from the clinical trials.

There is no guarantee that any CROs, investigators and other third parties upon which we rely for administration and conduct of our clinical trials will devote adequate time and resources to such trials or perform as contractually required or that these third parties will adequately perform all of their contractual obligations to us. If any of these third parties fail to meet expected deadlines, compromise the quality or accuracy of clinical trial data by failing to adhere to its clinical protocols or otherwise perform in a substandard manner, such as by failing to follow legal or regulatory requirements, our clinical trials may be extended, delayed, or terminated. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms or at all. If any of our clinical trial sites terminate for any reason, we may experience the loss of follow-up information on patients enrolled in our ongoing clinical trials unless we are able to transfer the care of those patients to another qualified clinical trial site. Switching or adding additional third-party service providers involves additional cost and requires management time and focus. In addition, there is a natural transition period when a new third-party service provider begins work. As a result, delays may occur, which can materially impact our ability to meet our desired development timelines.

In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, the integrity of the data generated at the applicable clinical trial site may be jeopardized.

We have in-sourced part of the research, development, and clinical operations functions previously assigned to CROs, and we may not be able to efficiently execute those operations, or the cost savings expected from this transition may not materialize, which may adversely affect the financial performance of our business or our ability to advance our pipeline. While this approach could provide greater control over timelines, quality and intellectual property, it requires substantial investment in infrastructure, personnel and technology. We may face difficulty in recruiting and retaining experienced personnel necessary to support these functions in-house. Additionally, we may encounter inefficiencies or delays as we develop internal expertise and capacity, which could slow down our development programs. The shift to in-house operations also presents operational risks, as we bear greater responsibility for compliance with complex regulatory requirements, quality assurance and risk management previously handled by our CROs. Any failure to effectively manage these responsibilities could lead to regulatory setbacks or increased costs.

We may seek orphan drug designation, rare pediatric disease designation, or other FDA designations, but may not receive such designation. Even if the FDA grants the designation, we may not receive orphan drug exclusivity or a priority review voucher if the product candidate does not meet the FDA requirements at the time of approval or licensure. Typically, orphan drug designation is available for products intended to treat a disease or condition that affects fewer than 200,000 individuals in the United States. The sponsor must demonstrate that the product candidate meets the statutory criteria for orphan drug designation, and if a competitor receives orphan drug exclusivity for the same rare disease or condition, this may affect our ability to obtain orphan drug designation and/or exclusivity. We may also pursue rare pediatric disease designation for use of VMT-α-NET for advanced neuroblastoma. A PRV may be granted to a drug indicated for a rare pediatric disease. Under the current statutory framework, as reauthorized by the Consolidated Appropriations Act, 2026 (2026 Act), signed into law on February 3, 2026, the FDA may award a rare pediatric disease priority review voucher upon approval of a qualifying rare pediatric disease product application. The 2026 Act extended the program through September 30, 2029 and eliminated the prior two-part sunset structure, replacing it with a single expiration date after which the FDA may not award any rare pediatric disease PRVs unless the program is again reauthorized by Congress. Unlike the prior framework, the 2026 Act does not impose a separate deadline for obtaining rare pediatric disease designation, providing sponsors with greater flexibility in the timing of their development programs. There can be no assurance that the program will be reauthorized beyond September 30, 2029, and any failure by Congress to reauthorize the program could affect our ability to obtain a voucher in connection with any future approval of a qualifying product candidate.

We have received Fast Track designation for VMT-α-NET and VMT01, but such designation may not actually lead to a faster development or regulatory review or approval process. Additionally, the FDA may rescind the designation if it determines the applicable product candidate no longer meets the qualifying criteria for Fast Track. The FDA may grant Fast Track designation to a product candidate intended for the treatment of a serious condition and nonclinical or clinical data demonstrate the potential to address unmet medical need for this condition. We have received Fast Track designation for VMT-α-NET and VMT01. However, Fast Track designation does not ensure that we will receive marketing approval or that approval will be granted within any particular time frame. We may not experience a faster development or regulatory review or approval process with Fast Track designation compared to conventional FDA procedures. In addition, the FDA may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.

We will face intense competition and may not be able to compete successfully. We operate in highly competitive segments of the biotechnology and biopharmaceutical markets. We face competition from many different sources, including commercial pharmaceutical and biotechnology enterprises, academic institutions, government agencies, and private and public research institutions. VMT-α-NET, VMT01, PSV359 and our other future product candidates, if successfully developed and approved, will compete with established therapies, as well as new treatments that may be introduced by our competitors. Many of our competitors have significantly greater financial, product development, manufacturing, and marketing resources than us. Large pharmaceutical companies have extensive experience in clinical testing and obtaining regulatory approval for drugs. We also may compete with these organizations to recruit management, scientists, and clinical development personnel. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. New developments, including the development of other biological and pharmaceutical technologies and methods of treating disease, occur in the pharmaceutical and life sciences industries at a rapid pace. Developments by competitors may render our product candidates obsolete or noncompetitive. We will also face competition from these third parties in recruiting and retaining qualified personnel, establishing clinical trial sites and patient registration for clinical trials and in identifying and in-licensing new product candidates.

There are several companies developing alpha-based radiopharmaceuticals for the treatment of cancer, including Bayer, Novartis, Bristol Myers Squibb (through its acquisition of RayzeBio), Eli Lilly (through its acquisition of POINT Biopharma), Sanofi, Lantheus (through its acquisition of Evergreen), Telix Pharmaceuticals, Actinium Pharmaceuticals, RadioMedix, AdvanCell, Orano Med, Aktis Oncology, AstraZeneca (through its acquisition of Fusion Pharmaceuticals), Convergent Therapeutics, Johnson & Johnson, ARTBIO and Abdera. These companies use various alpha-emitting isotopes such as 223Ra, 225Ac, 212Pb and 221At. Most alpha-based radiopharmaceuticals are in clinical development, with Bayer’s Xofigo® being the only approved alpha particle-based therapy. Xofigo® was approved in 2013 for the treatment of symptomatic bone metastases in people with castration-resistant prostate cancer.

There are also companies with beta-based radiopharmaceuticals, both in development and already approved. There are multiple companies, including Lantheus, Novartis and Q BioMed Inc., with approved beta-based radiopharmaceutical products using isotopes such as 131I, 177Lu, 89Sr and 90Y. Novartis’ Lutathera® and Pluvicto® are prominent beta-based radioligands, and other beta-based radiopharmaceuticals are in various stages of clinical development by companies including Novartis, Curium SAS, Telix Pharmaceuticals Limited, Cellectar Biosciences, ITM, Actinium Pharmaceuticals, Lantheus, Blue Earth Therapeutics and Clarity Pharmaceuticals.

For our product candidate [212Pb]VMT-α-NET, we are aware of several competing therapies targeting neuroendocrine tumors. Novartis’ Lutathera®, which was approved in 2018, uses 177Lu for the treatment of individuals with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. We are aware of the following companies with neuroendocrine tumor, radioligand preclinical and clinical development programs: ITM, Bristol Myers Squibb (through its acquisition of RayzeBio), Eli Lilly (through its acquisition of POINT Biopharma) and Sanofi. We also face potential competition from other treatments targeting neuroendocrine tumors such as Sandostatin® and Afinitor® (Novartis), Somatuline® (Ipsen) and Sutent® (Pfizer). While we believe [212Pb]VMT-α-NET has significant advantages compared to conventional approaches to neuroendocrine tumors, we may still face competition from these more established treatments.

We may rely on market exclusivity periods that may not be or remain available to us. We may rely on our ability to obtain and maintain a regulatory period of market exclusivity for any of our product candidates, including VMT-α-NET, PSV359 and VMT01 that are successfully developed and approved for commercialization. The exclusivity period in Europe is currently 10 years from the date of marketing approval by the European Commission (EC). However, in April 2023, the EC published a proposal to reform this system. The EC, European Parliament and Council of the European Union (Council) have negotiated and reached an agreement on December 11, 2025. Under the agreed revision, the regulatory data protection will consist of eight years of data exclusivity, the same as under the current legal framework, and one additional year of market exclusivity. This means a total of 8+1 years of protection, instead of the current 8+2 years. Under the reformed legislation, there will be a possibility to obtain one additional year of exclusivity (8+1+1) under certain circumstances and another year (8+1+1 or 8+1+1+1) for a new indication of significant clinical benefit, with a capped overall regulatory protection of 11 years. Under the proposal, orphan market exclusivity will be reduced from the current 10 years to nine years. Extension by another two years will be possible for “breakthrough orphan medicinal products.” The final text of the reform proposal is expected to be endorsed and published in the first or second quarter of 2026 and, after a transition period, the new legislation is expected to start to apply from mid-2028. Once any regulatory period of exclusivity expires, depending on the status of its patent coverage and the nature of the program, we may not be able to prevent others from marketing products that are biosimilar to or interchangeable with our programs, which would materially adversely affect us.

We must deploy our sales and marketing capabilities to market and distribute and sell our programs if any of our product candidates are approved, and we may not be effective in doing so. We do not currently have the infrastructure for the sales, marketing and distribution of any of our product candidates and will need to hire a sales force and develop infrastructure to perform these functions in order to commercialize any programs that we may successfully develop. This sales function may also be outsourced which could lead to additional costs.

If any product candidate that we successfully develop does not achieve broad market acceptance among physicians, patients, healthcare payors and the medical community, the revenues that we generate from their sales will be limited. Even if VMT-α-NET, VMT01, PSV359 and our other product candidates receive regulatory approval, they may not gain market acceptance among physicians, patients, healthcare payors and the medical community. Coverage and reimbursement of our product candidates by third-party payors, including government payors, generally is also necessary for commercial success. The degree of market acceptance of any approved programs will depend on a number of factors, including:

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the efficacy and safety as demonstrated in clinical trials;

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the clinical indications for which the program is approved;

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acceptance by physicians, major operators of hospitals and clinics and patients of the program as a safe and effective treatment;

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acceptance of the program by the target population;

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the potential and perceived advantages of product candidates over alternative treatments;

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the safety of product candidates seen in a broader patient group, including its use outside the approved indications;

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the cost of treatment in relation to alternative treatments;

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the availability of adequate reimbursement and pricing by third parties and government authorities;

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relative convenience and ease of administration;

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the prevalence and severity of adverse events;

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the effectiveness of our sales and marketing efforts; and

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unfavorable publicity relating to the program.

If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate sufficient revenue from these programs and may not become or remain profitable.

Coverage and adequate reimbursement may not be available for our product candidates, if commercialized, which could make it difficult for us to sell any future products profitably. Market acceptance and sales of any products that we commercialize will depend in part on the extent to which reimbursement for these products and related treatments will be available from third-party payors, including government health administration authorities and private health insurers. Third-party payors decide which drugs they will pay for and establish reimbursement levels. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for each of our products will be made on a plan-by-plan basis. One payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage, and adequate reimbursement, for the product. Additionally, a third-party payor’s decision to provide coverage for a drug does not imply that an adequate reimbursement rate will be approved. Each plan determines whether or not it will provide coverage for a drug, what amount it will pay the manufacturer for the drug, and on what tier of its formulary the drug will be placed. The position of a drug on a formulary generally determines the copayment that a patient will need to make to obtain the drug and can strongly influence the adoption of a drug by patients and physicians. Patients who are prescribed treatments for their conditions and providers performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products.

A primary trend in the United States healthcare industry and elsewhere is cost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Inadequate coverage and reimbursement may impact the demand for, or the price of, any product for which we obtain marketing approval. If coverage and adequate reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize any product candidates that we develop.

Additionally, there have been a number of legislative and regulatory proposals to change the healthcare system in the United States and in some jurisdictions outside the United States that could affect our ability to sell any future products profitably. These legislative and regulatory changes may negatively impact the reimbursement for any future products, following approval.

Our success in international markets also depends upon the eligibility of our product for coverage and reimbursement through government-sponsored healthcare payment systems and third-party payors. Reimbursement practices vary significantly by country. Many international markets have government-managed insurance systems that control reimbursement for new products and procedures. Other foreign markets have both private insurance systems and government-managed systems that control reimbursement for new products and procedures. Market acceptance of any product that we commercialize may depend on the availability and level of coverage and reimbursement in any country within a particular time. In addition, healthcare cost containment efforts similar to those we face in the United States are prevalent in many of the other countries in which we may sell our products and these efforts are expected to continue.

Due to the significant resources required for the development of our drug candidates, we must prioritize development of certain drug candidates and/or certain disease indications and may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success. We plan to develop a pipeline of drug candidates to treat various tumors and other diseases states where targeted alpha-particle therapy may be effective. Due to the significant resources required for the development of drug candidates, we must focus our attention and resources on specific diseases and/or indications and decide which drug candidates to pursue and the volume of resources to allocate to each. We are currently focusing our resources on the development of our lead product candidates, VMT-α-NET for the treatment of somatostatin receptor type 2 positive neuroendocrine tumors, VMT01 for the treatment of patients with metastatic melanoma where the MC1R protein is expressed on the surface of the tumor and PSV359 for the treatment of multiple solid tumor types where fibroblast activation protein is expressed on tumor cells or tumor stroma.

Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular drug candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, any decision to delay, terminate or collaborate with third parties in respect of certain programs or product candidates may subsequently prove to be suboptimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the viability or market potential of any of our programs or product candidates or misread trends in the oncology field or biotechnology industry, our business, financial condition and results of operations could be materially adversely affected. As a result, we may fail to capitalize on viable commercial programs or profitable market opportunities, be required to forgo or delay pursuit of opportunities with other product candidates or other diseases and indications that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such product candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights.

If we fail to attract and retain key management, scientific and clinical development personnel, we may be unable to successfully develop or commercialize our product candidates. We are dependent on our management team, scientific personnel and clinical development personnel, and our success will depend on their continued service, as well as our ability to attract and retain other highly qualified employees, consultants and advisors for our business, including scientific, managerial and technical personnel. There is a shortage of highly qualified personnel in our industry. As a result, the market for the services of qualified personnel is highly competitive. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill sets. The inability to recruit and retain qualified personnel, or the loss of service of any member of our senior management team or key personnel could prevent, impair or delay the implementation of our business plans, the progress of our research, development and commercialization objectives, and could negatively impact our ability to succeed in our product development strategy. We are the beneficiary of a key man insurance policy for our CEO. We do not carry any key man insurance on any other member of our senior management team.

Legal and Regulatory Risks Related to Our Operations

Significant disruptions of information technology systems or cybersecurity incidents could materially adversely affect our business, results of operations and financial condition. We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on both our own information technology systems and infrastructure and the information technology systems and infrastructure of third parties to operate our business. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, cyber-attacks (including ransomware, malware attacks, unauthorized access attempts, and denial of service and other unintentional intrusions or malicious cyber-attacks), social engineering (including phishing) or other fraudulent schemes, and other cybersecurity incidents, as well as natural disasters, terrorism, war, telecommunication and electrical failures. These threats may arise from persons inside our organization, authorized persons with access to systems inside our organization, those with whom we do business or unauthorized individuals.

The risk of a cybersecurity incident or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that store or facilitate access to confidential information increases the risk of cybersecurity data security incidents, which could impact the confidentiality, integrity and availability of confidential information or other data we maintain or data maintained on our behalf. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data cybersecurity incident, and we rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and infrastructure and the processing, transmission and storage of digital information. However, there can be no assurance that our efforts to protect data and systems will prevent service interruption or the loss of confidential or other critical information from our or third-party providers’ information technology and infrastructure. The costs and operational consequences to us of maintaining reasonable security measures or of responding to cybersecurity incidents, including disruption, degradation, or manipulation of systems, networks or technology, or implementing remediation measures could be significant. Furthermore, threat actors may use AI tools to automate and enhance cybersecurity attacks against us. We use software and platforms designed to detect such cybersecurity threats, but these threats could become more sophisticated and harder to detect and counteract, which may pose significant risks to our data security and systems. Additionally, while we have implemented security measures that we believe are appropriate and continue to enhance cybersecurity protections, a regulator could deem our security measures not to be appropriate given the lack of prescriptive measures in certain data protection laws. Increased regulation of data collection, use and retention practices, including self-regulation and industry standards, changes in existing laws and regulations, enactment of new laws and regulations, increased enforcement activity, and changes in interpretation of laws, could increase our cost of compliance and operation, limit our ability to grow our business or otherwise harm our business.

To the extent that any disruption or cybersecurity incident results or appears to result in an interruption or loss of or damage to our information technology systems or infrastructure, or inappropriate disclosure of confidential information, we could incur material reputational harm, penalties, regulatory fines or scrutiny, liabilities, legal claims, and/or mandated changes in our business practices. Furthermore, if our information technology systems and infrastructure, or those of third parties on which we rely, suffer severe damage, disruption or shutdown and our business continuity plans do not effectively resolve the issues in a timely manner, we could experience delays in reporting our financial results, violate our loan covenants, miss reporting deadlines, and the development of our product candidates could be delayed. Additionally, if such interruption or cybersecurity incident were to occur or appear to occur, it could result in a material disruption of our development programs. For example, the loss or alteration of clinical trial data from planned, completed or ongoing clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data and reduce trial participants’ or patients’ trust in us. A significant cybersecurity incident may also deter new clinical trial participants from participating in our trials. Such events could also lead to an interruption in our supply chain for the manufacturing of clinical and commercial drug substance and drug product, as well as related materials, and could significantly impact development and commercialization timelines and capabilities.

In addition, such a cybersecurity incident may require notification to governmental agencies, the media, or individuals pursuant to various federal, state or foreign privacy and security laws, if applicable, including HIPAA, and its implementing rules and regulations, as well as regulations promulgated by the SEC, the Federal Trade Commission (FTC) and state comprehensive privacy and breach notification laws.

While we have purchased cybersecurity insurance, there are no assurances that the coverage would be adequate in relation to any incurred losses. Moreover, as cyber-attacks increase in frequency and magnitude, we may be unable to obtain cybersecurity insurance in amounts and on terms we view as adequate for our operations.

We are subject to a variety of global privacy laws, rules and regulations, and our failure to comply with them could harm our business. We are subject to the General Data Protection Regulation, as well as the UK General Data Protection Regulation (collectively, GDPR), which imposes obligations and restrictions on our ability to collect, analyze, use, store, disclose, transfer or otherwise process personal data, including health data from clinical trial subjects. The GDPR imposes a broad range of obligations and restrictions relating to the processing and protection of personal data, including obligations to having a legal basis for processing personal data (which may result in some instances in obtaining the consent of the individuals to whom the personal data relates), providing detailed information about the processing activities, ensuring adequacy, relevance and necessity of the personal data collected, ensuring that appropriate data retention policies and procedures are implemented, the dealing with restrictions on sharing of personal data with third parties, the transferring of personal data outside of the EU/UK, having contractual arrangements in place where required (such as with clinical trial sites and vendors), having appropriate technical and organizational security measures in place to protect personal data, having policies and procedures in place to identify, investigate, handle, mitigate and report personal data breaches to data protection authorities and/or affected individuals, appointing data protection officers, conducting data protection impact assessments, responding to privacy rights requests and keeping records of processing activities.

For instance, as we may rely on third parties to process personal information on our behalf as a processor (for example, in the context of the manufacturing of our drug candidates or for the conduct of clinical trials), we must contractually ensure that strict security measures, as well as appropriate reporting and cooperation obligations including but not limited to an obligation to report any security incident to us without undue delay, are implemented, in order to allow us to comply with our own regulatory requirements under the GDPR.

With regard to transfer of personal data, the GDPR restricts the ability of companies to transfer personal data from the EU to the U.S. and other countries, which may adversely affect the ability of us to transfer personal data or otherwise may cause us to incur significant compliance costs for implementing lawful transfer mechanisms, conducting data transfer impact assessments, and implementing additional measures where necessary to ensure that personal data transferred are adequately protected in a manner essentially equivalent to the requirements of the GDPR. The GDPR provides different transfer mechanisms we can use to lawfully transfer personal data from the EU to countries outside the EU. An example is relying on adequacy decisions of the European Commission, such as the EU-U.S. Data Privacy Framework. In July 2023, the European Commission adopted its adequacy decision for the EU-U.S. Data Privacy Framework. The adequacy decision concludes that the U.S. ensures an adequate level of protection (compared to that of the EU) for personal data transferred from the EU to U.S. companies participating in the EU-U.S. Data Privacy Framework. The adequacy decisions of the European Commission are subject to periodic reviews and may be amended or withdrawn. Another example of a lawful transfer mechanism is using the EU Standard Contractual Clauses as approved by the European Commission in June 2021. In order to use the EU Standard Contractual Clauses mechanism, the exporter and the importer must ensure that the importer may guarantee a level of personal data protection in the importing country that is essentially equivalent to that of the European Economic Area. Compliance with EU data transfer obligations involves conducting transfer impact assessments, which includes documenting detailed analyses of data access and protection laws in the countries in which data importers are located, which can be costly and time consuming. Data importers must also expend resources in analyzing their ability to comply with transfer obligations, including implementing new safeguards and controls to further protect personal data.

Data protection authorities from the different European Member States and the UK may interpret the GDPR and applicable related national laws differently and impose requirements additional to those provided in the GDPR and that sit alongside the GDPR, as set out under applicable local data protection laws. In addition, guidance on implementation and compliance practices may be issued, updated or otherwise revised. Enforcement by European and UK regulators is generally active, and failure to comply with the GDPR or applicable Member State/UK local law may result in fines or other enforcement actions (such as notices requiring compliance within a certain timeframe). Further, the EU regulators or the UK Government may amend/update data protection laws, which may result in changes to our business operations and potentially incur commercial cost.

The GDPR may increase our responsibility and liability in relation to personal data that we process, and we may be required to expend significant capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against cybersecurity incidents or to mitigate issues that result from such incidents. This may be onerous, and if our efforts to comply with the GDPR or other applicable EU laws and regulations are not successful, it could adversely affect our business.

Moreover, as a result of the broad scale release and availability of Artificial Intelligence (AI) technologies such as generative AI, there is a global trend towards more regulation (e.g., the EU AI Act and AI laws passed in U.S. states) to ensure the ethical use, privacy, and security of AI and the data that it processes. Compliance with such laws may be an increasing and substantial cost in the future.

If we fail to comply with global data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation and/or adverse publicity, which could negatively affect our operating results and business. We are subject to federal, state and foreign laws and regulations governing privacy and security of personal information, including health information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues that may affect our business. These laws may differ from each other in significant ways, thus complicating compliance efforts. Compliance efforts will likely be an increasing and substantial cost in the future. Failure to comply with such laws and regulations could result in government enforcement actions and create liability for us, including but not limited to imposition of significant penalties, private litigation (including class actions) and/or adverse publicity that could negatively affect our business. The GDPR provides for fines in the event of any non-compliance. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with EU data protection authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR.

Several U.S. states have proposed and passed consumer privacy laws. For example, the California Consumer Privacy Act of 2018 includes certain requirements for processing personal data, including obligations related to transparency and the collection, use, retention and disclosure of personal data, and grants California consumers with certain rights regarding their personal data. In addition, California consumers have the right to bring a private right of action in connection with data security incidents involving certain elements of personal data. Additionally, nearly two dozen other states have enacted similar legislation and/or regulations. Health-specific consumer privacy laws were also enacted in multiple states, including Washington and Nevada. These laws and regulations are constantly evolving and may impose limitations on our business activities. Similarly, there are a number of legislative proposals in the U.S., at both the federal and state level, that could impose new obligations or limitations in areas affecting our business. These laws and regulations are evolving and subject to interpretation, and may impose limitations on our activities or otherwise adversely affect our business.

The FTC also sets expectations for taking appropriate steps to keep consumers’ personal information secure and providing a level of security commensurate with promises made to individuals about the security of their personal information (such as in a privacy notice) in a way that may constitute unfair or deceptive acts or practices in violation of Section 5(a) of the Federal Trade Commission Act (FTC Act). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. With respect to privacy, the FTC also sets expectations that companies honor the privacy promises made to individuals about how the company handles consumers’ personal information. Any failure to honor such promises, such as the statements made in a privacy policy or on a website, may also constitute unfair or deceptive acts or practices in violation of the FTC Act. The FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may result in FTC enforcement. Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions. The FTC also has the power to enforce the Health Breach Notification Rule, which imposes notification obligations on companies for breaches of certain health information contained in personal health records. The FTC has brought enforcement actions under both Section 5 of the FTC Act and the Health Breach Notification Rule.

HIPAA imposes privacy and security obligations on covered entity healthcare providers, health plans and healthcare clearinghouses, as well as their “business associates;” i.e., certain persons or entities that create, receive, maintain or transmit protected health information in connection with providing a specified service or performing a function on behalf of a covered entity. Although we are not directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates or our agents knowingly receive individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA and may be subject to other civil and/or criminal penalties if we obtain, use or disclose information in a manner not permitted by other privacy and data security and consumer protection laws.

Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations. We are exposed to the risk that our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers and other vendors, may engage in misconduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA, EMA/EC and other similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies; manufacturing standards; healthcare fraud and abuse, data privacy laws and other similar laws; or laws that require the true, complete and accurate reporting of financial information or data. Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical trials, the creation of fraudulent data in our preclinical studies or clinical trials, or illegal misappropriation of product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. In addition, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and financial results, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in governmental healthcare programs, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

If we fail to comply with applicable healthcare regulations, we could face substantial penalties, and our business, operations and financial condition could be adversely affected. Certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights may be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business (among others). The laws that may affect our ability to operate (including following commercialization of any of our products) include, but are not limited to:

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the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, the referral of an individual for the furnishing or arranging for the furnishing of any item or service, or the purchase, lease, order, arrangement for, or recommendation of the purchase, lease, or order of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A violation of the Anti-Kickback Statute may be established without proving actual knowledge of the statute or specific intent to violate it. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act;

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the federal civil False Claims Act, which imposes civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement material to false or fraudulent claim; conspiring to defraud the government by getting a false or fraudulent claim paid or approved by the government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. Actions under the False Claims Act may be brought by private individuals known as qui tam relators in the name of the government and to share in any monetary recovery;

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HIPAA, which includes federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third party payors, knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements or representations in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

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HIPAA and its implementing regulations, which impose privacy and security requirements on entities covered by HIPAA, including certain healthcare providers, health plans and healthcare clearinghouses as well as their respective business associates that create, receive, maintain, or transmit protected health information in connection with providing a specified service or performing a function on behalf of a covered entity;

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the federal Physician Payment Sunshine Act and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS by the 90th day following each calendar year information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain other advanced practitioners and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

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the U.S. Foreign Corrupt Practices Act of 1977, as amended (FCPA), a U.S. law that regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals); and

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state law equivalents of the federal laws, such as anti-kickback, false claims, consumer protection and unfair competition laws which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payors, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances many of which differ from each other in significant ways, with differing effect. Additionally, the compliance environment is changing, with some states mandating implementation of compliance programs, compliance with industry ethics codes and spending limits, and other states requiring reporting to state governments or the banning of certain gifts, compensation and other remuneration to physicians. Still other laws require licensing of sales representatives.

Many of these laws provide for substantial penalties for noncompliance. The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different compliance and/or reporting requirements, increases the possibility that a company may inadvertently run afoul of one or more laws.

Governmental regulations outside the U.S. have become increasingly stringent and more common, and we may become subject to more rigorous regulation by governmental authorities in the future. Penalties for a company’s noncompliance with governmental regulation could be severe, including fines and revocation or suspension of a company’s business license, mandatory price reductions and criminal sanctions. Any governmental law or regulation imposed in the future may have a material adverse effect on us.

Because of the breadth of these various fraud and abuse laws, it is possible that some of our business activities could be subject to challenge under one or more of such laws. Such a challenge could have material adverse effects on our business, financial condition, and operations. In the event governmental authorities conclude that our business practices do not comply with any of the laws described above or the other governmental regulations to which we, our distributors or our customers are subject, the government may impose sanctions under these laws, which are potentially significant and may include civil monetary penalties, damages, restitution, fines, exclusion from Medicare, Medicaid and other government programs, criminal fines and imprisonment, and the curtailment or restructuring of our operations. If we are required to obtain permits or licensure under these laws that we do not already possess, we may become subject to substantial additional regulation or incur significant expense. Any penalties, damages, fines, curtailment or restructuring of our operations would adversely affect our ability to operate our business and our financial results. The risk of our being found in violation of these laws is increased by the fact that many of them have not been fully or clearly interpreted by the regulatory authorities or the courts, and their provisions are subject to a variety of interpretations and additional legal or regulatory change. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

Changes in U.S. and international trade policies may adversely impact our business and operating results. From time to time, proposals are made to significantly change existing trade agreements and relationships between the U.S. and other countries. In recent years, the U.S. government has implemented substantial changes to U.S. trade policies, including import restrictions, increased import tariffs and changes in U.S. participation in multilateral trade agreements. Because some of our vendors, manufactures and suppliers are located in foreign countries, we are exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies, laws, rules and regulations of the United States or foreign governments, as well as political unrest or unstable economic conditions in foreign countries. The U.S. government has indicated its intent to adopt a new approach to trade policy and in some cases to renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements. These newly proposed and imposed tariffs have resulted in threatened and actual retaliatory tariffs against U.S. goods. Certain equipment and supplies used in the manufacture of our products may in the future be subject to these tariffs, which could increase our manufacturing costs and could make our products, if successfully developed and approved, less competitive than those of our competitors whose inputs are not subject to these tariffs. We may otherwise experience supply disruptions or delays, and our suppliers may not continue to provide us with clinical supply in our required quantities, to our required specifications and quality levels or at attractive prices. In addition, certain Chinese biotechnology companies and CMOs may become subject to trade restrictions, sanctions, other regulatory requirements, or proposed legislation by the U.S. government, which could restrict or even prohibit our ability to work with such entities, thereby potentially disrupting the supply of material to us. Such disruption could have adverse effects on the development of our product candidates and our business operations.

We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and noncompliance with such laws can subject us to criminal and/or civil liability and harm our business. We are subject to the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector. We engage third-party investigators, CROs and other consultants to design and perform preclinical studies of our drug candidates and will do the same for any clinical trials. Also, once a drug candidate has been approved and commercialized, we may engage third-party intermediaries to promote and sell our programs abroad and/or to obtain necessary permits, licenses and other regulatory approvals. We or our third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities. We will be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, collaborators, partners, and agents, even if we do not explicitly authorize or have actual knowledge of such activities. Our international suppliers create the risk of unauthorized payments or offers of payments by one of our employees, consultants, sales agents, or distributors, because these parties are not always subject to our control.

Noncompliance with anti-corruption and anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage and other collateral consequences. If any subpoenas, investigations, or other enforcement actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed. In addition, responding to any action will likely result in a materially significant diversion of management’s attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.

Healthcare reform measures could hinder our product candidates’ commercial success. In both the United States and certain foreign jurisdictions there have been, and we anticipate there will continue to be, a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell any future products profitably. In the United States, the Affordable Care Act provides for a number of requirements that are applicable to us, including a number of Medicare provisions aimed at improving quality and decreasing costs which may have unintended consequences on patient access to new technologies. The Medicare provisions include ongoing value-based payment programs, funding of comparative effectiveness research, reduced hospital payments for avoidable readmissions and hospital acquired conditions, and adjustments to the annual Medicare payment updates.

Our ability or the ability of our collaborators to commercialize any of our product candidates that we successfully develop may depend, in part, on the extent to which government health administration authorities, private health insurers and other organizations will reimburse consumers for the cost of these programs. These third parties are increasingly challenging both the need for and the price of new drug products. Significant uncertainty exists as to the reimbursement status of newly approved therapeutics. Adequate third-party reimbursement may not be available for our product candidates to enable us or our collaborators to maintain price levels sufficient to realize an appropriate return on our investment in research and product development.

The potential pricing and reimbursement environment for VMT-α-NET, VMT01, PSV359 and our other product candidates and any future programs may change in the future and become more challenging due to, among other reasons, policies advanced by the current or any new presidential administration, federal agencies, healthcare legislation passed by Congress, or fiscal challenges faced by all levels of government health administration authorities. Further, OBBBA is projected to decrease federal health care spending by approximately $1 trillion by reducing Medicaid spending and enrollment and making changes to federal Medicare spending.

In the EU, an important and foreseeable example of reform measures is the forthcoming EU pharmaceutical legislation revision. In April 2023, the European Commission published a proposal to reform the current European pharmaceutical legislative framework. The legislative proposal would change European Union pharmaceutical law with respect to, among other topics, regulatory data exclusivity, orphan market exclusivity, environmental risk assessment, medicines shortages. In December 2025, the European Commission, European Parliament and the Council reached an agreement on pharmaceutical reform. The final text of the reform proposal is expected to be endorsed and published in the first or second quarter of 2026 and, after a transition period, the new legislation is expected to start to apply from mid-2028.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to make and implement healthcare reforms may adversely affect:

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our ability to set a price we believe is fair for our program;

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our ability to generate revenues and achieve or maintain profitability;

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the availability of capital; and

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our ability to obtain timely approval of any future program modifications.

The Centers for Medicare & Medicaid Services (CMS) has also implemented regulations under the ACA related to disclosure of payments made by manufacturers to physicians and teaching hospitals. Following commercialization of any of our products, the tracking and reporting of these payments could have an adverse impact on our business and/or consolidated results of operations and financial condition and on our relationships with customers and potential customers.

Since its enactment, there have been judicial challenges, as well as efforts by Congress to modify, and agencies to alter the implementation of, certain aspects of the ACA and related laws. In the future, Congress may consider other legislation to modify elements of the ACA or related laws or enact other healthcare reform measures, agencies may further alter their implementation of elements of the ACA or related laws or implement other such measures, and other judicial challenges to elements of the ACA or related law or other healthcare reform measures may be brought. The extent to which any such changes may impact our business or financial condition is uncertain.

State legislatures also have shown significant interest in implementing cost-containment programs or policies to limit the growth of healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs. For example, some states have established Prescription Drug Affordability Boards (or similar entities) to review high-cost drugs and, in some cases, set upper payment limits.

We expect that these and other healthcare reform measures in the future may result in more rigorous coverage criteria or lower reimbursement, or in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may hinder us in generating revenue, attaining profitability or commercializing our drugs once marketing approval is obtained.

If, once we offer commercialized products, we participate in the Medicaid Drug Rebate Program and other governmental pricing programs, failure to comply with obligations under these programs could result in additional price concession requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, operations and financial condition. Under the Medicaid Drug Rebate Program, a participating manufacturer is required to pay a rebate to each state Medicaid program for its covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by the state Medicaid program as a condition of having federal funds being made available for drugs under Medicaid and Medicare Part B. Those rebates are based on pricing data reported by the manufacturer on a monthly and quarterly basis to CMS. These data include the average manufacturer price and, in the case of innovator products, the best price for each drug, which, in general, represents the lowest price available from the manufacturer to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity in the U.S. in any pricing structure, calculated to include all sales and associated rebates, discounts and other price concessions. If a manufacturer fails to pay the required rebate amount or report pricing data on a timely basis, it may be subject to civil monetary penalties and/or termination from the Medicaid Drug Rebate program. Additionally, civil monetary penalties can be applied if the manufacturer is found to have knowingly submitted any false price or product information to the government, if the manufacturer fails to submit the required price data on a timely basis, or if the manufacturer misclassifies or misreports product information. CMS could also decide to terminate any Medicaid Drug Rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs, if commercialized. A manufacturer’s failure to comply with such price reporting and rebate payment requirements could negatively impact our financial results.

Federal law requires that a manufacturer also participate in the 340B Drug Pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs to a specified “covered entities,” including community health centers and other entities that receive certain federal grants, as well as certain hospitals that serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program. If a manufacturer is found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price for any of our commercialized products, it could be subject to significant civil monetary penalties and/or such failure could be grounds for the Health Resources and Services Administration to terminate our agreement to participate in the 340B program, in which case our covered outpatient drugs, once commercialized, would no longer be eligible for federal payment under the Medicaid or Medicare Part B program.

Pricing and rebate calculations are complex, vary across products and programs, and are often subject to interpretation by the manufacturer, governmental agencies, and courts. A manufacturer that becomes aware that its Medicaid reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, is obligated to resubmit corrected data up to three years after those data originally were due. Restatements and recalculations increase the costs for complying with the laws and policies governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters. They also may affect the 340B ceiling price and therefore liability under the 340B program.

Further, the IRA established Medicare Part B and Part D inflation rebate schemes and a drug price negotiation program, with the first negotiated prices to take effect in 2026. Manufacturers may be subject to civil monetary penalties for certain violations of the negotiation and inflation rebate provisions and an excise tax during any noncompliance period under the negotiation program.

In addition, some states have established price reporting and related requirements, to which certain penalties attach. These state programs, in addition to the Medicaid, 340B, FSS, and Tricare programs, could adversely affect the success of any products that we commercialize in the future. If we fail to comply with any applicable obligations under governmental pricing programs that we participate in, we could be subject to additional reimbursement requirements, significant civil monetary penalties, sanctions and fines, and those could negatively impact our business, financial condition, results of operations and growth prospects. Additionally, if we offer cost-sharing assistance to patients, pharmacy benefit manager “accumulator” programs (including copayment “maximizer” programs) may negatively affect our financial results.

In order to be eligible to have its products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by the Big Four agencies and certain federal grantees, a manufacturer is required to participate in the VA Federal Supply Schedule (FSS) pricing program, established under Section 603 of the Veterans Health Care Act of 1992. Under this program, the manufacturer is obligated to make its covered drugs available for procurement on an FSS contract and charge a price to the Big Four agencies that is no higher than the FCP, which is a price calculated pursuant to a statutory formula. The FCP is derived from a calculated price point called the “non-federal average manufacturer price” (Non FAMP), which the manufacturer calculates and reports to the VA on a quarterly and annual basis. Pursuant to applicable law, knowing provision of false information in connection with a Non FAMP filing can subject a manufacturer to significant penalties for each item of false information. The FSS contract also contains extensive disclosure and certification requirements. If we overcharge the government in connection with the FSS contract, whether due to a misstated FCP or otherwise, we will be required to refund the difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the False Claims Act and other laws and regulations. Unexpected refunds to the government, and any response to government investigation or enforcement action, would be expensive and time consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Under Section 703 of the National Defense Authorization Act for FY 2008, the manufacturer is required to pay quarterly rebates to DoD on utilization of its innovator products that are dispensed through DoD’s Tricare network pharmacies to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non FAMP and FCP for the calendar year that the product was dispensed. A manufacturer that fails to comply with the requirements of the Tricare Retail Pharmacy Rebate Program may have its products excluded from Tricare retail pharmacies and/or the Tricare pharmacy benefits program; may be subject to interest, penalties and administrative fees; and, depending on the actions of the manufacturer, may be subject to allegations under the False Claims Act and other laws and regulations.

Failure to comply with government regulations could harm our business. As a targeted alpha therapy manufacturer, we are subject to extensive, complex, costly, and evolving governmental rules, regulations and restrictions administered by the FDA, the FAA and other federal and state agencies, and by governmental authorities in other countries. Compliance with these laws and regulations is expensive and time consuming, and changes to or failure to comply with these laws and regulations, or adoption of new laws and regulations, could adversely affect our business.

In the United States, as a manufacturer of targeted alpha therapy utilizing radioactive by-product material, we are subject to extensive regulation by federal, state and local governmental authorities, such as the FDA and the NRC, to ensure such products are safe and effective. Regulations promulgated by the FDA under the U.S. Food, Drug and Cosmetic Act, govern the design, development, testing, manufacturing, packaging, labeling, distribution, marketing and sale, post-market surveillance, repairs, replacements, and recalls of our product candidates.

The FAA has authority to regulate, through its Office of Hazardous Materials Safety, the offering for shipment of hazardous materials onboard aircraft, including radioactive materials of the type marketed by us. The FAA is also responsible for enforcement of hazardous materials regulations for air transportation promulgated by the United States Pipeline and Hazardous Materials Safety Administration. Because we ship hazardous materials on flights in the U.S., we are subject to these regulations, including periodic audit and, if applicable, enforcement action by the FAA. As they apply to us, the FAA regulations concern the packaging and labeling of hazardous materials. If we fail to comply with these regulations, we could face civil or criminal penalties. The NRC and Agreement States license and regulate the possession, use and disposal of radioactive byproduct material as well as the manufacture of radioactive sealed sources to ensure compliance with state and federal laws and regulations. Our targeted alpha therapy programs are subject to these regulations, and a violation of these regulations could lead to civil enforcement action by the NRC or an Agreement State having jurisdiction, including imposition of civil monetary penalties depending on the significance of the violation.

In addition to FDA-required market approvals for our product candidates, our manufacturing operations are required to comply with the FDA’s CGMP regulations, which address requirements for a company’s quality program such as management responsibility, good manufacturing practices, product and process design controls, and quality controls used in manufacturing. For example, the manufacturing facility we recently acquired in Somerset, NJ, is a CGMP compliant facility, and we utilize the facility to manufacture clinical supply of high quality 212Pb-labeled radiopharmaceuticals to treat target tumors with TAT. We will need to ensure that the facility, including our three CGMP suites, continue to meet the standards necessary to be a CGMP-compliant facility.

Compliance with applicable regulatory requirements is monitored through periodic inspections by the FDA Office of Regulatory Affairs. We anticipate both announced and unannounced inspections by the FDA. Such inspections could result in noncompliance reports (Form 483) which, if not adequately responded to, could lead to enforcement actions. The FDA can institute a wide variety of enforcement actions ranging from public warning letters to more severe sanctions such as fines; injunctions; civil penalties; recall of our program; operating restrictions; suspension of production; non-approval or withdrawal of pre-market clearances for new programs or existing programs and criminal prosecution. There can be no assurance that we will not incur significant costs to comply with these regulations in the future or that the regulations will not have a material adverse effect on our business, financial condition and results of operations.

In addition to the ACA, various healthcare reform proposals have also emerged at the state level. Like the ACA, these proposals could reduce medical procedure volumes and impact the demand for our program or the prices at which we sell our program. The impact of these proposals could have a material adverse effect on our business and/or consolidated results of operations and financial condition.

Any cuts to Medicare reimbursement which affect our program could have a material adverse effect on our business and/or our consolidated results of operations and financial condition.

The marketing of our program in foreign countries will, in general, be regulated by foreign governmental agencies similar to the FDA. Foreign regulatory requirements vary from country to country. The time and cost required to obtain regulatory approvals could be longer than that required for FDA clearance in the United States and the requirements for licensing a program in another country may differ significantly from FDA requirements. We will rely, in part, on foreign distributors to assist us in complying with foreign regulatory requirements. We may not be able to obtain these approvals without incurring significant expenses or at all, and the failure to obtain these approvals would prevent us from selling our program in the applicable countries. This could limit our sales and growth.

Our business exposes us to product liability claims. We face an inherent risk of product liability exposure based on our previously marketed products, the use of VMT-α-NET, VMT01, PSV359 and other product candidates in human clinical trials, or, if obtained, following their marketing approval and commercialization. Claims could be brought against us if use or misuse of one of our product candidates causes, or merely appears to have caused, personal injury or death. Although we have and intend to maintain product liability insurance relating to our previously marketed products and clinical trials, our coverage may not be sufficient to cover claims that may be made against us, and we may be unable to maintain such insurance. Any claims against us, regardless of their merit, could severely harm our financial condition, strain our management and other resources or destroy the prospects for commercialization of the program which is the subject of any such claim. We are unable to predict if we will be able to obtain or maintain product liability insurance for any programs that may be approved for marketing. Additionally, we have entered into various agreements under which we are required to indemnify third parties for certain claims relating to the testing and use of our product candidates. These indemnification obligations may require us to pay significant sums of money for claims that are covered by these indemnification obligations.

We cannot predict all of the possible harms or side effects that may result from the use of our programs and, therefore, the amount of insurance coverage we currently hold, or that we or our collaborators may obtain, may not be adequate to protect us from any claims arising from the use of its programs that are beyond the limit of its insurance coverage. If we cannot protect against potential liability claims, we or our collaborators may find it difficult or impossible to commercialize our programs, and we may not be able to renew or increase our insurance coverage on reasonable terms, if at all. The marketing, sale and use of our programs and our planned future programs could lead to the filing of product liability claims against us if someone alleges that our programs failed to perform as designed. A product liability or professional liability claim could result in substantial damages and be costly and time consuming for us to defend.

Any product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage. Additionally, any product liability lawsuit could damage our reputation, result in the recall of programs, or cause current partners to terminate existing agreements and potential partners to seek other partners, any of which could impact our results of operations.

Although we believe that as of the date of this Annual Report, we have adequate insurance to address anticipated potential liabilities associated with product liability, any unforeseen product liability exposure in excess of, or outside the scope of, such insurance coverage could adversely affect our financial condition and operating results. Any such claim brought against us, with or without merit, could result in significant damage to our business. Insurance coverage is expensive and difficult to obtain and, although we currently have a $10 million policy, in the future we may be unable to obtain or renew coverage on acceptable terms, if at all. If we are unable to obtain or renew sufficient insurance at an acceptable cost or if a successful product liability claim is made against us, whether fully covered by insurance or not, our business could be harmed. The FDA’s reporting regulations require us to report any incident in which our program may have caused or contributed to a death or serious injury. Any required filing could result in an investigation of our program and possibly subsequent regulatory action against us if it is found that one of our programs caused the death or serious injury of a patient.

Our business involves environmental risks. Our business involves the controlled use of hazardous materials, including chemicals and biological and radioactive compounds, that could be dangerous to human health and safety or could contaminate the environment. Manufacturing is extremely susceptible to product loss due to radioactive, microbial, or viral contamination; material or equipment failure; vendor or operator error; or the very nature of a radioactive product’s short half-life. Although we believe that our procedures for handling, storing, using, labeling and disposing of such materials comply with state and federal standards, if we fail to comply with such standards, we could face substantial fines, restrictions on our operations or possible revocation of our authority to conduct some of our operations. In addition, environmental, health and safety requirements have become, and may continue to become, increasingly stringent, and our costs may increase as a result. New or revised laws and regulations or new interpretations of existing laws and regulations could affect the operation of our business or result in significant additional expense and operating restrictions on us.

Moreover, regardless of our compliance, there will always be some risk of accidental contamination or injury for which we could be held liable. Contamination may cause the closure of the manufacturing facility for an extended period of time. By law, radioactive materials and hazardous wastes may only be disposed of at approved facilities. We use commercial disposal contractors for such disposal as needed.

We remain responsible for any radioactive waste produced during our ownership of the facility for our discontinued brachytherapy operations and will incur costs related to the clean up and disposal of hazardous materials, chemicals, and radioactive components of this facility. While management believes it has reserved a sufficient amount of funds for this process, we may need more than the amount of the expense accrual related to this radioactive waste. We may incur substantial costs related to the clean up and disposal of these materials.

In addition, certain environmental laws and regulations impose liability on current or previous owners or operators of real property for the costs of investigation, removal or remediation of releases of hazardous substances or petroleum products at or from those properties. Further, we may be liable if we arrange for the treatment or disposal of hazardous substances, without regard to whether we complied with environmental laws in doing so. Liability for investigative, removal and remedial costs or natural resource damages under certain U.S. federal and state laws are retroactive, strict, and joint and several. In addition to actions for such liability brought by governmental authorities, private parties could bring claims for clean-up costs, personal injury or property damage due to the presence of, or exposure to, hazardous substances. Further, the government could impose liens on, or restrict our operations at, any contaminated properties. The outcome of the foregoing and timing of future cash outflows is difficult to predict, given the uncertainties regarding the extent of any injuries, damages or required clean up, the interpretation of applicable laws and regulations, and alternative clean-up methods.

In April 2023, the European Commission published a proposal to reform the current European pharmaceutical legislative framework. This proposal imposes stricter rules regarding the “Environmental Risk Assessment” that pharmaceutical manufacturers are obliged to perform. Under the current Environmental Risk Assessment guidelines, an Environmental Risk Assessment is required for all new applications for marketing authorization of medicinal products for human use. Under the proposed legislation, there will be more extensive Environmental Risk Requirements, where noncompliance with the Environmental Risk Assessment requirements can result in the withdrawal or refusal of a marketing authorization. In December 2025, the European Commission, European Parliament and the Council reached an agreement on the pharmaceutical reform. The final text of the reform proposal is expected to be endorsed and published in the first or second quarter of 2026 and, after a transition period, the new legislation is expected to start to apply from mid-2028.

Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile. We hold a number of insurance policies, including (among others) product liability insurance, directors’ and officers’ liability insurance, cybersecurity insurance and workers’ compensation insurance. If the costs of maintaining adequate insurance coverage increase significantly in the future, our operating results could be materially adversely affected. Likewise, if any of our current insurance coverage should become unavailable to us or become economically impractical, we would be required to operate our business without indemnity from commercial insurance providers. If we operate our business without insurance, we could be responsible for paying claims or judgments against us that would have otherwise been covered by insurance, which could adversely affect our results of operations or financial condition.

Continuing regulatory liability may exist from our discontinued operations. Our legacy brachytherapy manufacturing operations were required to comply with the FDA’s Quality System Regulation (QSR), which imposes requirements for a company’s quality program such as management responsibility, good manufacturing practices, product and process design controls, document controls, purchasing controls and acceptance activities, nonconforming product requirements, corrective and preventive action requirements, labeling and packaging controls, handling, storage and distribution requirements, complaint handling, records requirements and other quality controls used in manufacturing. Additionally, labeling and promotional activities are subject to agency scrutiny. Although we divested our brachytherapy segment, the FDA may still hold us accountable for violations of the QSR, labeling and promotional rules, and other regulations that occurred prior to divesting the business segment.

Risks Related to Intellectual Property Matters

Our success will depend upon intellectual property, proprietary technologies and regulatory market exclusivity periods, and we may be unable to protect our intellectual property. Our success will depend, in significant part, on our ability to obtain, maintain, enforce, and defend patent protection, regulatory exclusivity, and trade secret protection for VMT-α-NET, VMT01, PSV359, our other programs, and our radiopharmaceutical-related technologies, including their formulations, manufacture, and methods of use. If we or our licensors fail to properly prosecute, maintain, enforce, or defend our intellectual property rights, or fail to obtain or maintain applicable regulatory exclusivities for our product candidates and other programs, our ability to develop and commercialize such assets could be adversely affected, and we may be unable to adequately protect our competitive position. Any failure to sufficiently protect the intellectual property relating to our product candidates and other programs or related technologies could have a material adverse effect on our business, financial condition, and results of operations.

The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or our licensors will be successful in obtaining, maintaining, enforcing, or defending patent protection for our product candidates and other programs. These risks and uncertainties include the following:

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patent applications may not result in issued patents;

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any patents that are issued or in-licensed may be challenged in administrative or judicial proceedings, including opposition, inter partes review, post-grant review, reexamination, or other proceedings, and may be invalidated, narrowed, modified, revoked, circumvented, found unenforceable, or otherwise fail to provide meaningful protection or competitive advantage;

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our competitors, many of which have substantially greater financial, technical, and other resources than us or our partners and may have made significant investments in competing technologies, may seek to obtain, or may already have obtained, patents or other intellectual property rights that could limit, interfere with, or preclude our ability to develop, manufacture, use, or commercialize our current or future product candidates or other programs;

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there may be significant pressure on the U.S. government and other governmental authorities to limit the scope or enforceability of patent protection, in the U.S or abroad, for disease diagnoses or treatments that are deemed to address significant public health concerns;

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patent laws and regulations in jurisdictions outside the U.S. States may provide less protection to patent holders than the laws of the U.S., thereby permitting competitors to develop and commercialize competing products in such jurisdictions;

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patent laws, regulations, and their interpretation in the U.S. and other jurisdictions are subject to change, which could adversely affect our ability to obtain or enforce patent protection; and

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we may become involved in litigation or other proceedings to protect or enforce our patents or those of our licensors, which could be costly, time consuming, divert management’s attention, and may not result in favorable outcomes.

In addition to patents and regulatory exclusivity, we and our licensors may also rely on trade secrets and proprietary know-how to protect certain aspects of our technologies, product candidates and other programs. Although we have implemented measures designed to safeguard our trade secrets and confidential information, including entering into confidentiality agreements with third parties, and confidentiality agreements and invention assignment agreements with our employees, consultants, and advisors, these measures may not be effective. Third parties may improperly obtain or disclose our trade secrets or confidential information, or independently develop substantially equivalent proprietary information or knowledge.

In addition, we may become subject to claims that we or our employees, consultants, advisors or independent contractors have inadvertently or otherwise improperly used or disclosed trade secrets or other proprietary information of their former employers or other third parties. Any such claims, regardless of merit, could result in costly litigation, require us to modify our technology or business practices, or otherwise adversely affect our business.

Our ability to compete may be adversely affected if we do not adequately protect our proprietary rights. Our success depends, in part, on obtaining and maintaining proprietary rights to our proprietary technologies, product candidates and other programs for the diagnosis and/or treatment of diseases including cancer, as well as on successfully defending these rights against third-party challenges. We will only be able to protect our drug candidates and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them. Our ability to obtain, maintain, enforce and defend patent protection for our proprietary technologies, product candidates and other programs is uncertain due to a number of factors, including (but not limited to):

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we may not have been the first to conceive of, reduce to practice or file patent applications covering the inventions claimed in our pending patent applications or issued patents;

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we may not have been the first to file patent applications for our proprietary technologies, product candidates or other programs or the related compositions or their methods of use;

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third parties may independently develop identical, similar or alternative technologies, products, compositions or methods of use;

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the disclosures in our patent applications may not satisfy the statutory requirements for patentability, including novelty, nonobviousness, written description, enablement or adequate support for the claimed subject matter;

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any or all of our pending patent applications may not result in issued patents;

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we may not seek or obtain patent protection in jurisdictions that may ultimately represent a significant business opportunity or provide a viable commercial market;

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any patents issued to us may not provide commercially meaningful protection, may not provide competitive advantages or may be challenged, narrowed, invalidated or rendered unenforceable by third parties;

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our compositions, manufacturing methods or methods of use may ultimately be determined to be unpatentable;

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third parties may design around our patent claims to develop competing technologies or products that fall outside the scope of our patents; and

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third parties may identify prior art or other grounds that could invalidate, limit or otherwise impair our patents.

Even if we have or obtain or in-license patents directed to our product candidates and other programs, related compositions, manufacturing methods or other technologies, we may still be barred from developing, manufacturing, using or commercializing such products or technologies because of the patent rights of others. Third parties may have filed, and in the future may file, patent applications or obtain patents claiming compositions, products, technologies, methods of manufacture or methods of use that are similar or identical to ours. There are numerous issued or pending U.S. and foreign patents relating to technologies, chemical compounds and therapeutic products that may be relevant to our current or future product candidates and other programs. These could materially affect our ability to develop, commercialize or out-license our drug candidates or other programs, if approved. Because patent applications are typically maintained in confidence for a period of time after filing, and because the patent prosecution process can take many years, there may be pending applications unknown to us that may later result in issued patents that our drugs, drug candidates, compositions or technologies may infringe. Such patents may have filing dates earlier than those of patent applications filed by us or our licensors, which could further limit our ability to obtain or maintain patent protection or to commercialize our products.

Obtaining and maintaining a patent portfolio entails significant expense and resources. Part of the expense includes periodic maintenance fees, renewal fees, annuity fees, various other governmental fees on patents and/or applications in multiple jurisdictions over the lifetime of such patents and/or applications, as well as the cost associated with complying with numerous procedural provisions during the patent application process. We may or may not choose to pursue or maintain protection for particular inventions. In addition, there are situations in which failure to make certain payments or noncompliance with certain requirements in the patent process can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If we choose to forgo patent protection or allow a patent application or patent to lapse purposefully or inadvertently, our competitive position and business prospects could suffer.

We may be unable to adequately obtain, protect, enforce or defend our intellectual property rights or to secure and maintain rights to third-party intellectual property necessary for the development and commercialization of our product candidates and other programs. Our ability and the abilities of our collaborators and licensors to obtain and maintain patent and other protection for our program will affect our success. We own, co-own or hold exclusive licenses to patents and patent applications pending in the U.S. and numerous foreign jurisdictions. The patent positions of biopharmaceutical companies are often highly uncertain and involve complex legal and factual questions. Our patents and patent applications may be challenged, opposed, invalidated, narrowed, found unenforceable or otherwise fail to provide adequate protection if subjected to administrative or judicial proceedings. Even if upheld, our patent rights may not provide meaningful competitive advantages and may be circumvented, designed around or infringed by our competitors. In addition, we may not seek or obtain patent protection in all jurisdictions in which protection may be desirable, and we may lack the financial or other resources necessary to enforce our intellectual property rights globally.

Because of the large number of patent filings in the biotechnology field, our competitors may have filed applications or been issued patents and may obtain additional patents and proprietary rights relating to our program or processes competitive with or similar to ours. We cannot be certain that U.S. or foreign patents do not exist or will not be issued that would harm our ability to develop, manufacture or commercialize our product candidates. If such third-party rights are asserted against us, we may be required to obtain licenses, modify our technologies, or cease certain activities, any of which could materially adversely affect our business, financial condition, and results of operations.

Potential patent litigation could be costly and disruptive and may have an adverse effect on our business, financial condition and results of operations. We operate in an industry characterized by extensive intellectual property litigation and administrative proceedings. Potential claims may include challenges to the validity, enforceability, ownership or scope of our patents or other intellectual property rights as well as allegations that our programs, product candidates, technologies or methods of us infringe, misappropriate or otherwise violate patents or other intellectual property rights held by competitors or other third parties. An unfavorable outcome in any such proceeding could result in, among other things, the loss, narrowing, or invalidation of our patent rights; the inability to obtain or maintain regulatory approvals; injunctions preventing the development, manufacture, or commercialization of our product candidates; the need to obtain licenses on unfavorable terms, if at all; or the payment of substantial damages, including treble damages and attorneys’ fees in the event of a finding of willful infringement. Any such outcome could adversely affect our competitive position, business prospects, financial condition, and results of operations.

Our commercial success will depend in part on our ability to develop, manufacture and commercialize our product candidates without infringing, misappropriating or otherwise violating the intellectual property rights of third parties. Intellectual property litigation and other proceedings are inherently complex, costly and time consuming, and their outcomes are difficult to predict. Any pending or future patent litigation or administrative proceeding could result in significant damage awards, including treble damages under certain circumstances, and injunctions or other equitable relief that could delay or prevent the development, manufacture or commercialization of an affected product candidate. In addition, we could be required to obtain licenses from third parties on unfavorable terms, if at all, in order to continue operating our business. At any given time, we may be involved as either a plaintiff or a defendant patent infringement or other intellectual property actions, the outcomes of which may not be known for prolonged periods of time. As a participant in the healthcare and biopharmaceutical industries, we can expect to face claims of patent infringement or other violations of intellectual property rights in the future. Any successful claim of patent or other intellectual property infringement against us could adversely affect our business, results of operations and financial condition.

Our success also depends upon our ability and the ability of any current or future collaborators to develop, manufacture, market and commercialize our product candidates without infringing, misappropriating or otherwise violating the intellectual property rights of third parties. Numerous United States and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing programs, some of which may be directed at claims that overlap with or are similar to the subject matter of our product candidates, technologies or other intellectual property. Because patent applications can take many years to issue, there may be pending applications, unknown to us, which may later result in issued patents that our product candidates or proprietary technologies may infringe. Similarly, there may be issued patents relevant to our product candidates of which we are not aware. Any such third-party intellectual property rights could require us to obtain licenses on unfavorable terms, modify our technologies or product candidates, or cease certain development or commercialization activities, any of which could adversely affect our business, financial condition, and results of operations.

There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. If a third party claims that we or any of our licensors, suppliers or collaborators infringe, misappropriate or otherwise violate the third party’s intellectual property rights, we may have to:

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obtain licenses, which may not be available on commercially reasonable terms, if at all;

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suspend, delay, abandon or redesign an affected product candidate technology or process to avoid infringement;

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pay substantial damages, including the possibility of treble damages and attorneys’ fees in the event of a finding of willful infringement;

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pay ongoing royalties or fees and/or grant cross licenses to our intellectual property on terms that may be unfavorable to us; and/or

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defend against litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

The value of our granted patents and our pending patents is uncertain. Although our management believes that our patents, pending patent applications and anticipated future patent applications that have not yet been filed may have significant value, we cannot be certain that other like-kind processes may not exist or be discovered, that any of these patents is enforceable, or that any of our pending or future patent applications will result in issued patents.

Some of the intellectual property that is important to our business is owned by third parties and licensed to us, and changes in or termination of our rights under these license agreements may adversely impact our business. Termination of these licenses or reduction or elimination of our licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms, or could subject us to claims of intellectual property infringement or contract breach in litigation or other administrative proceedings that could result in damage awards against us and injunctions that could prohibit us from selling our products. In addition, some of our licenses from third parties may limit the field in which we can use the licensed technology. In the event a dispute with our licensors were to occur, our licensors may seek to renegotiate the terms of our licenses, increase the royalty rates that we pay to obtain and maintain those licenses, limit the field or scope of the licenses, or terminate the license agreements. In addition, we have limited rights to participate in the prosecution and enforcement of the patents and patent applications that we have licensed. If we fail to meet our obligations under these licenses, or if we have a dispute regarding the terms of the licenses, these third parties could terminate the licenses, which could impede our ability to develop our products and subject us to claims of intellectual property infringement. As a result, we cannot be certain that these patents and applications will be prosecuted and enforced in a manner consistent with our best interests.

We may be subject to claims that we or our employees, consultants, contractors or advisors have infringed, misappropriated or otherwise violated the intellectual property of a third party, or claiming ownership of what we regard as our own intellectual property. Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees do not use the intellectual property and other proprietary information, know-how or trade secrets of others in their work for us, we may be subject to claims that we or these employees have used or disclosed such intellectual property or other proprietary information. Litigation may be necessary to defend against these claims.

In addition, while we generally require our employees, consultants and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. To the extent that we fail to obtain such assignments, that such assignments do not contain a self-executing assignment of intellectual property rights or that such assignments are breached, we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms or at all. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our management and scientific personnel.

Some of our technology is subject to “march-in” rights by the U.S. government. Some of our patented technology may have been developed with U.S. federal government funding. When new technologies are developed with U.S. government funding, the government obtains certain rights in any resulting patents, including a nonexclusive license authorizing the government to use the invention for non-commercial purposes. These rights may permit the government to disclose our confidential information to third parties and to exercise “march-in” rights to use or allow third parties to use our patented technology. The government can exercise its march-in rights if it determines that such action is necessary to (i) achieve practical application of the U.S. government-funded technology, (ii) alleviate health or safety needs, (iii) meet requirements of federal regulations, or (iv) give preference to U.S. industry. In addition, U.S. government-funded inventions must be reported to the government and such government funding must be disclosed in any resulting patent applications. Furthermore, our rights in such inventions are subject to government license rights and foreign manufacturing restrictions. The U.S. government has generally denied requests to exercise its march-in rights, even to provide access to potentially life-saving medications; however, if the U.S. government were to exercise its march-in rights to our patent technologies funded by the U.S. government, particularly for the benefit of one of more of our competitors, that may have a material adverse effect on our business.

Risks Related to Ownership of Shares of Common Stock and Public Company Status

The concentration of our common share ownership will likely limit the ability of other shareholders to influence corporate matters. As of March 12, 2026, executive officers, directors, 5% or greater shareholders, and their respective affiliated entities beneficially owned, in the aggregate, approximately 33,621,109 of the shares of our outstanding common stock, par value $0.001 per share (Common Stock). Lantheus Alpha Therapy, LLC, a Delaware limited liability company and wholly owned subsidiary of Lantheus Holdings, Inc. (Lantheus) owned approximately 10.2% of the shares of our outstanding Common Stock as of March 12, 2026.

As a result, Lantheus can significantly influence the outcome of matters requiring shareholder approval, including the election of directors, amendments of our organizational documents, or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common shares that you may feel are in your best interest. The interests of Lantheus may not always coincide with your interests or the interests of other shareholders and they may act in a manner that advances their best interests and not necessarily those of other shareholders, including seeking a premium value for their common shares. These actions might affect the prevailing market price for our common shares. In addition, Lantheus and certain of our other principal shareholders that have held their shares for several years may be more interested in selling our company to an acquirer than other investors, or they may want us to pursue strategies that deviate from the interests of other shareholders. Such concentration of ownership control may also:

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delay, defer or prevent a change in control;

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entrench our management and/or our Board of Directors; or

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impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.

Our stock price has been and may continue to be volatile. The market price of our Common Stock has experienced fluctuations and is likely to fluctuate significantly in the future. For example, during 2025 and through March 12, 2026, the closing price of one share of our Common Stock reached a high of $5.65 and a low of $1.71. There is generally significant volatility in the market prices and limited liquidity of securities of companies which have failed to show profits. Contributing to this volatility are various events that can affect our stock price in a positive or negative manner. These events include, but are not limited to: governmental approvals or refusals to approve drug products; delays in or termination of clinical trials; clinical data readouts from our clinical trials; market acceptance of our product candidates; announcements by competitors of new product candidates or technologies; litigation involving us or our industry; developments or disputes concerning our patents or other proprietary rights; changes in the structure of healthcare payment systems; departures of key personnel; future sales of our securities; fluctuations in our financial results or those of companies that are perceived to be similar to us; investors’ general perception of us; and general economic, industry and market conditions. In addition, the securities of many biotechnology and pharmaceutical companies, including us, have historically been subject to extensive price and volume fluctuations that may affect the market price of their common stock. If any of these events occur, it could cause our stock price to rise or fall. As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares.

The price of our Common Stock may be adversely affected by the future issuance and sale of shares of our Common Stock or other equity securities. Sales of a substantial number of shares of our Common Stock or other equity securities, or the perception by the market that those sales could occur, could cause the market price of our Common Stock to decline or could make it more difficult for us to raise funds through the sale of equity in the future. In August 2024, we entered into a Controlled Equity OfferingSM Sales Agreement (2024 ATM Agreement) with Cantor Fitzgerald & Co. and RBC Capital Markets, LLC (each, an ATM Agent, and together, the ATM Agents) pursuant to which we, from time to time, may offer and sell shares (2024 ATM Shares) of our Common Stock, through or to the ATM Agents having an aggregate sales price of up to $250.0 million. As of March 12, 2026, $239,794,281 of Common Stock remains available for issuance under the 2024 ATM Agreement. In addition, in February 2026, we issued 39,576,088 shares of Common Stock, and, in lieu of shares to certain investors, pre-funded warrants to purchase 6,598,046 shares of Common Stock, in each case in connection with an underwritten offering of securities. Future issuances of our Common Stock or our other equity securities could further depress the market for our Common Stock. We expect to continue to incur commercialization, drug development and selling, general and administrative costs, and to satisfy our funding requirements, we may need to sell additional equity securities. The sale or the proposed sale of substantial amounts of our Common Stock or our other equity securities may adversely affect the market price of our Common Stock, and our stock price may decline substantially. Our stockholders may experience substantial dilution and a reduction in the price that they are able to obtain upon sale of their shares. New equity securities issued may have greater rights, preferences or privileges than our existing common stock.

We do not expect to pay any dividends for the foreseeable future. We do not anticipate paying any dividends to our stockholders for the foreseeable future. Stockholders must be prepared to rely on sales of their common stock after price appreciation to earn an investment return, which may never occur. Any determination to pay dividends in the future will be made at the discretion of our Board of Directors and will depend on our results of operations, financial conditions, contractual restrictions, restrictions imposed by applicable laws and other factors that our Board of Directors deems relevant.

Perspective Therapeutics, Inc. (CATX) Risk Factors

ITEM 1A – RISK FACTORS

Risks Related to Our Business, Financial Results and Need for Additional Capital

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The net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparisons of our results of operations may not be a good indication of our future performance.

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Risks Related to Our Business and Industry

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•the risk that patients enrolled in clinical trials will drop out of the trials before completion, including as a result of changing standards of care or the ineligibility of a site to participate.

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•the quality or stability of the product candidate may fall below acceptable standards.

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•the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

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Any of these events could prevent us from achieving or maintaining market acceptance of the particular program, if approved, and could significantly harm our business, results of operations and prospects.

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If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate sufficient revenue from these programs and may not become or remain profitable.

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Legal and Regulatory Risks Related to Our Operations

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Any cuts to Medicare reimbursement which affect our program could have a material adverse effect on our business and/or our consolidated results of operations and financial condition.

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Risks Related to Intellectual Property Matters

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•we may become involved in litigation or other proceedings to protect or enforce our patents or those of our licensors, which could be costly, time consuming, divert management’s attention, and may not result in favorable outcomes.

•third parties may identify prior art or other grounds that could invalidate, limit or otherwise impair our patents.

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•defend against litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

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Risks Related to Ownership of Shares of Common Stock and Public Company Status

•impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.

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the risk that patients enrolled in clinical trials will drop out of the trials before completion, including as a result of changing standards of care or the ineligibility of a site to participate.

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the quality or stability of the product candidate may fall below acceptable standards.

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the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

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we may become involved in litigation or other proceedings to protect or enforce our patents or those of our licensors, which could be costly, time consuming, divert management’s attention, and may not result in favorable outcomes.

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third parties may identify prior art or other grounds that could invalidate, limit or otherwise impair our patents.

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defend against litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and management resources.

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impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.