Perspective Therapeutics (CATX) Risk Analysis

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 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-a-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.

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-a-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-a-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-a-NET is entitled "A Phase 1/2a First-in-Human Study of [212Pb]VMT-a-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.

Results of current and future clinical trials of VMT-a-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-a-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: - regulatory authorities may withdraw approvals of such program;- regulatory authorities may require additional warnings in the program's labeling;- 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;- we could be sued and held liable for harm caused to patients; and - 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.

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: - deficiencies in the conduct of the clinical trials, including failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;- deficiencies in the clinical trial operations or trial sites;- the product candidate may have unforeseen adverse side effects;- deficiencies in the trial design necessary to demonstrate efficacy;- fatalities or other adverse events arising during a clinical trial due to medical problems that may not be related to clinical trial treatments;- the product candidate may not appear to be more effective than current therapies; or - 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-a-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.

Although our Phase 1/2a clinical trials are ongoing, the completion of clinical trials can be delayed for a variety of reasons, including: - 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;- 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;- identifying, recruiting and training suitable clinical investigators;- 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;- obtaining sufficient quantities of investigational product for our product candidates for use in clinical trials;- obtaining IRB or ethics committee approval to conduct a clinical trial at a prospective site;- 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;- 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;- changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;- inability to identify and maintain a sufficient number of suitable trial sites;- failure of CROs to meet their contractual obligations or deadlines;- the need to modify a trial protocol;- unforeseen safety issues;- emergence of dosing issues;- lack of effectiveness data during clinical trials;- changes in the standard of care of the indication being studied;- 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;- inability to monitor subjects adequately during or after treatment;- 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;- changes in governmental regulations or administrative action; and - 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.

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.