CATX 10-K & 10-Q changes, risk factors and insider trading
Perspective Therapeutics, Inc. · NYSE · Pharmaceutical Preparations · CIK 728387 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Largest changes
“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. …”see in full comparison
Significant disruptions of information technology systems orsee in full comparisonbreachescybersecurityof data securityincidents 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 personalinformation. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and we rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure and, as a result, a number of third-party vendors may or could have access to our confidentialinformation. 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,malware,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 electricalfailures,failures.cyber-attacksTheseorthreatscyber-intrusionsmayoverarisethe Internet, attachments to emails,from persons inside our organization,orauthorized persons with access to systems inside ourorganization.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. …”see in full comparison
“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 could be an increasing and substantial cost in the future.”see in full comparison
patentsee in full comparisonlawslaws, regulations, andregulationstheir interpretation in theUnited StatesU.S. and other jurisdictionsand judicial interpretation of such laws and regulationsare subject tochangechange, which could adversely affect our ability to obtain or enforce patent protection; and we maybebecome involved inlawsuitslitigation or other proceedings to protect or enforce our patents orthe patentsthose of our licensors, which could beexpensive,costly, timeconsumingconsuming, divert management’s attention, andunsuccessful.may not result in favorable outcomes.
“Social media platforms have significantly altered the dynamics of corporate communications and present risks and challenges, some of which are, and may continue to be unknown to us. As social media continues to expand, it also presents us with new challenges. The inappropriate or unauthorized use of our confidential information on media platforms could cause brand damage or information leakage, which would cause legal or regulatory issues for us. …”see in full comparison
Full comparison: every changed paragraph (161)
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, VMT01VMT01, PSV359 and our other program candidates,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 programproduct candidates. The successful commercialization of any of our program candidates will require us to perform a variety of functions, including:
The successful commercialization of any of our product candidates will require us to perform a variety of functions, including:
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 programproduct candidates, if approved;
obtaining reimbursement or pricing for our programproduct candidates that supports profitability; and managing our spending and cash requirements as our expenses are expected to continue to increase dueas we continue to researchinvest in the development of our product candidates and preclinicalother work,radiopharmaceutical clinicalprograms, trials,expand regulatoryour approvals,manufacturing capabilities and undertake commercialization and maintaining our intellectual property portfolio.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 early-stage clinical trials for VMT-α-NET, VMT01VMT01, PSV359 and our other program candidates.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, VMT01VMT01, PSV359 or any of our other program candidatesprograms 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 theour programproduct candidates is approved for marketing, we anticipate incurring significant costs associated with commercialization of such programproduct candidate(s). Portions of our current pipeline of programproduct candidates have been in-licensed from third parties, which makemakes 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 programproduct candidates. Additionally, if we are not able to gain market acceptance for our programproduct 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 $226.9$144.7 million as of December 31, 2024.2025. 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, 20242025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current plannedclinical operationsmilestones and operational investments into late 2026.2027. 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 programother candidatespreclinical programs and technologies in our pipeline. In particular, our funding needs may vary depending on a number of factors including:
In particular, our funding needs may vary depending on a number of factors including:
the extent to which we continue the development of our programproduct candidates or form licensing arrangements to advance our programproduct candidates;
the expansion of our manufacturing capabilities and the costs and timing associated therewith;
our decisions to in-license or acquire additional programs, additional programproduct candidates or technology for development;
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 programproduct candidates;
whether batches of programproduct candidates that we manufacture fail to meet specifications resulting in clinical trial delays and investigational and remanufacturing costs;
the decisions, and the timing of decisions, made by health regulatory agencies regarding our technologytechnology, product candidates and programother candidatesprograms;
competing programs, programproduct candidates and technological and market developments; and prosecuting and enforcing our patent claims and other intellectual property rights.
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 programproduct candidates,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.
significantly delay, scale back or discontinue the development or commercialization of one or more of our programproduct candidates or other programs or one or more of our research and development initiatives;
seek collaborators for one or more of our programproduct 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;
sell or license on unfavorable terms our rights to one or more of our technologies, programproduct candidates or other programs or research and development initiatives that we otherwise would seek to develop or commercialize ourselves;
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, 20242025 and have not receivedgenerated any revenues other than from our brachytherapy business, which was divested in April 2024. From inception to December 31, 2024,2025, we have an accumulated deficit of approximately $231.7$334.8 million. Investment in drug development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a programproduct 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 programproduct 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.
continue our research and preclinical and clinical development of our programproduct candidates and other programs;
initiate additional preclinical, clinical or other studies or trials for our programproduct candidates and other programs;
seek regulatory approvals for our programproduct candidates that successfully complete clinical trials;
establish a sales, marketing and distribution infrastructure to commercialize any programproduct candidates for which we may obtain regulatory approval;
seek to identify and validate additional programproduct candidates;
acquire or in-license other programproduct candidates and technologies;
create additional infrastructure to support our research, product developmentdevelopment, manufacturing and planned future commercialization efforts; and 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 comparisoncomparisons of our results of operations may not be a good indication of our future performance.
Our programproduct 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 of or the termination of any clinical trial of our programproduct 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 programproduct 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 programproduct 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.
Clinical trials of our program 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. 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, PSV359VMT01 and VMT01.PSV359. All three trials are registered with ClinicalTrials.gov. For VMT-α-NET and VMT01, weWe have completed dosing our firstinitial 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 programproduct 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 programproduct candidates may be observed at any time, including in clinical trials or when a programproduct is commercialized. Undesirable side effects caused by our programproduct 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 programproduct 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 programproduct 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 programproduct 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 (DoEDOE). Our alpha-particle therapies require Thorium-228, which is a radioactive metallic chemical. In January 2021, we entered into a 10-year contract with the DoEDOE 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 purchasesupply ordersagreements with the DoEDOE 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 DoEDOE 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.
the suitability and location of clinical trial sites;
Our clinical trials will compete with other clinical trials for programproduct candidates that are in the same therapeutic areas as our programproduct 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 site.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 programproduct 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 programproduct 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 programproduct 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 programproduct 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 programproduct candidates. Although our Phase 1/2a clinical trials are ongoing, the completion of clinical trials can be delayed for a variety of reasons, including:
obtaining sufficient quantities of investigational product for our programproduct candidates for use in clinical trials;
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;
inability to identify and maintain a sufficient number of suitable trial sites;
reliance on third-party suppliers forrelating to the clinical trial supply of programproduct 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;
Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our programproduct 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 programproduct 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 programproduct 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.
the programproduct candidate may have unforeseen adverse side effects;
the programproduct candidate may not appear to be more effective than current therapies; or the quality or stability of the programproduct 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 programproduct candidates, the commercial prospects for that programproduct candidate will be harmed and our ability to generate product revenue from that programproduct 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 programproduct candidate and could substantially increase the costs of commercializing our programproduct candidates and impair our ability to generate revenue from the commercialization of these programproduct 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 programproduct candidates from applicable regulatory authorities, we will not be able to market and sell those programproduct 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 (TPDHealth Canada), the European Medicines Agency (EMA) and the European Commission (EC), is unpredictable but typically takes many years followingfrom the commencementinitiation 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 programproduct candidates depends on obtaininggenerating thesufficient finalclinical resultsand nonclinical data, including adequate characterization and control of requiredmanufacturing clinical testing and non-clinical testing, including characterization of the manufactured components of our program candidatesprocesses and validation of our manufacturing processes,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 programproduct candidate in any jurisdiction, and it is possible that none of our existing programproduct candidates or any programproduct candidates we may seek to develop in the future will ever obtain regulatory approval.
The FDA, theHealth TPD and/orCanada, the EMA/EC and, where applicable, the EC, can delay, limit or deny approval of VMT-α-NET, VMT01, PSV359 and our other programproduct candidates for many reasons, including any one or more of the following:
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a programproduct candidate is safe and effective for its proposed indication;
the results of clinical trials may not meetdemonstrate thestatistically levelrobust of statistical significance required by the FDA and/or comparableclinically foreignmeaningful regulatoryresults authoritiessufficient forto support approval;
we may be unable to demonstrate that a programproduct candidate’s clinical and other benefits outweigh its safety risks;
the data collected from clinical trials of our programproduct 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;
the FDA or comparable foreign regulatory authorities may failrequire toadditional hold to previous agreementsdata or commitmentsimpose conditions that differ from prior guidance or interactions;
the FDA or comparable foreign regulatory authorities may fail to approve our product candidates;
the FDA or comparable foreign regulatory authorities may failfind to approvethat our programmanufacturing candidatesprocess(es) and or data integrity systems are inadequate during pre-approval inspection and/or routine inspection; and 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 programproduct candidates, which would significantly harm our business, results of operations and prospects.
Disruptions at the FDA, including due to a reductionlapse in the FDA’s workforceappropriations 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, changes in government; budget and funding levels; orworkforce areductions; reduction inand the FDA’s workforce and its ability to hire and retain keyqualified personnel. Such changes and other disruptions at the FDA may increase the time to meet with the FDA andFDA, 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. In addition, governmentGovernment proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and other related government agencies. ForBudgetary example,pressures, theworkforce current presidential administration recently established the Department of Government Efficiency, which implemented a federal government hiring freeze and announced certain additional efforts to reduce federal government employee headcount and the size of the federal government. It is unclear how these executive actionsreductions, or otherchanges potentialin actionsagency bypriorities themay administrationimpair, delay or other parts of the federal government will impact the FDA or other regulatory authorities that oversee our business. Budgetary pressures may reduce the FDA’s ability to perform its responsibilities. If the FDA experiences a significantmaterial reduction in the FDA’s workforce occurs, the FDA’sits budget is significantly reduced or a prolonged government shutdown occurs, it could significantly impactshutdown, the agency’s ability of the FDA to timely review and process our regulatory submissionssubmissions, conduct inspections, or take other actions critical to the development or marketing of our productsproduct ifcandidates approved,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.
Management's Discussion & Analysis (MD&A)
New heading “Legislative Update”
Removed heading “Amended and Restated Equity Incentive Plan”
Removed heading “Brachytherapy Divestiture”
Removed heading “Legal Contingencies”
Removed heading “Cash Flows from Operating Activities”
Removed heading “Cash Flows from Investing Activities”
Removed heading “Cash Flows from Financing Activities”
Largest changes
“Goodwill represents the excess of the cost of net assets acquired in business combinations over the fair value of the identifiable tangible and intangible assets acquired and liabilities assumed in a business combination. We test goodwill and indefinite-lived intangibles for impairment at least annually in the fourth quarter by assessing qualitative factors to determine whether it is more likely than not that the fair value of the assets is below their carrying value. …”see in full comparison
“Goodwill impairment was $24.1 million for the year ended December 31, 2024, compared to $0.0 million for the year ended December 31, 2023, an increase of $24.1 million. Due to the volatility in the capital markets, particularly in the life sciences capital markets, we performed an impairment analysis as of December 31, 2024 as called for by GAAP. The analysis determined that, due to our low market capitalization, the goodwill that arose during the merger with Viewpoint Molecular Targeting, Inc. …”see in full comparison
“We also performed our annual qualitative goodwill impairment analysis as of October 31, 2024, and determined that the fair value of our sole reporting unit exceeded its book value. However, we began experiencing a decline in our stock market price in November, consistent with the overall life sciences industry, and performed an interim goodwill impairment analysis as of December 31, 2024. In connection with that analysis, we determined that our goodwill was impaired. …”see in full comparison
“Net cash used in operating activities of $18.3 million in the year ended December 31, 2024 was primarily due to a net loss of approximately $79.3 million, as adjusted for non-cash expenses totaling $29.2 million (such as goodwill impairment, share-based compensation and depreciation and amortization), partially offset by $31.8 million in changes in operating assets and liabilities, primarily related to the $28.0 million in cash we received pursuant to that certain option agreement, dated January 8, 2024, by and between us and Lantheus Alpha Therapy, LLC.”see in full comparison
“As a result of a decline in our stock price and related market capitalization in November 2024 that continued into December 2024, we performed a quantitative impairment assessment of our goodwill. The goodwill was determined to be fully impaired as of December 31, 2024, and we recorded a goodwill impairment charge of $24.1 million for the year ended December 31, 2024. This impairment charge reduced the balance of goodwill to $0 at December 31, 2024.”see in full comparison
“We have initiated dosing of patients in Cohorts 1 and 2 of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. In April 2024, we announced that this program was selected by the U.S. Food and Drug Administration (FDA) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. …”see in full comparison
Full comparison: every changed paragraph (162)
We are a radiopharmaceutical development company that is pioneering advanced treatment applicationstreatments for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity.
Our neuroendocrine tumor (VMT-α-NET), melanoma (VMT01) and neuroendocrinesolid tumor (VMT-α-NETPSV359) programs are in Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors in the U.S. We are growing our regional network of drug product finishing facilities, enabled by our proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations.
We designed VMT-α-NET to target and deliver 212Pb to target cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers. [212Pb]VMT-α-NET is a targeted alpha therapy (TAT) in development for patients with unresectable or metastatic SSTR2-expressing tumors who have not previously received peptide-targeted radiopharmaceutical therapy, such as Lutathera. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.
We initially dosed two patients in Cohort 1 (treated at 2.5 mCi per dose) and seven patients in Cohort 2 (treated at 5.0 mCi per dose) of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in the seven patients enrolled in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5.0 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation.
In late June 2025, we announced the opening of Cohort 3 in which patients will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi every eight weeks if they weigh more than 60 kg (133 lb), or 100μCi/kg of body weight if they weigh less than or equal to 60 kg. Eight Cohort 3 patients then commenced treatment with VMT-α-NET and contributed to the DLT assessment by the SMC. The DLT assessment is now complete, and we are cleared to treat more patients at this dose, with eight additional patients already treated as of February 28, 2026, for a total of 16 patients. By mid-2026, the eight DLT patients would have had the opportunity for at least 32 weeks of follow up since beginning treatment, which is sufficient time to have completed at least one scan following the full course of treatment.
During October 2025, updated interim results from our ongoing Phase 1/2a clinical trial (NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs with a data cut-off date of September 12, 2025, were presented at the European Society for Medical Oncology (ESMO) Congress 2025, the 2025 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. In this analysis, 55 patients across three dose cohorts received at least one treatment of VMT-α-NET. Two patients in Cohort 1 and 23 patients in Cohort 2 had at least nine months of follow up since their initial treatment.
During January 2026, updated interim results with a data cut-off date of December 10, 2025, were presented at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO-GI 2026). The 56 patients in the safety analysis comprised two patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi) and eight patients in Cohort 3 (6.0 mCi), each of whom had received at least one treatment. There were no DLTs, no treatment-related discontinuations, and no serious renal complications, dysphagia or clinically significant treatment-related myelosuppression reported. Grade 3 or higher treatment-emergent adverse events were reported in 21 patients (37.5%). One of these patients, who was enrolled in Cohort 3, experienced a transient Grade 4 event (lymphocyte count decrease). This event was transient and resolved without medical intervention. The patient continues to receive [212Pb]VMT-α-NET treatment. There were no Grade 5 events. Serious adverse events were reported in five patients, with none deemed related to the study medication.
In October 2025 at ESMO, we reported interim efficacy data for two patients in Cohort 1 and 23 patients in Cohort 2. At ASCO-GI 2026, we presented updated efficacy analysis for the same 25 patients from ESMO with an additional 13 weeks of follow up since the presentation at ESMO. Of the 25 patients, 19 (76%) were without progression and remained alive, including both of the patients in Cohort 1. Nine (39%) patients in Cohort 2 were observed to have response according to investigator-assessed RECIST v1.1. Eight (35%) of those responses were confirmed and previously reported at ESMO; one additional patient experienced an initial response in their most recent tumor assessment after the prior update at ESMO. As the patient remains on the study, the patient is expected to receive a subsequent tumor assessment. Seven patients were observed to have deepening of best response, including one patient with stable disease.
As of February 28, 2026, the first 23 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow up since beginning treatment, and by mid-2026, we expect all 46 patients in Cohort 2 would have had the opportunity for at least 48 weeks of follow up since beginning treatment.
We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.
During the dose finding phase of the study, we enrolled primarily NETs patients whose disease originated in the pancreas or the digestive track. We have allowance for enrollment of NETs patients whose disease originated in the lung (of which small cell lung cancer is a subset), and pheochromocytoma/paraganglioma NETs, as well as SSTR2+ meningioma.
We have initiated dosing of patients in Cohorts 1 and 2 of our Phase 1/2a study of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs. In April 2024, we announced that this program was selected by the U.S. Food and Drug Administration (FDA) to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The FDA’s CDRP Program was initiated in 2022 to facilitate alignment of CMC development of novel products under investigational new drug (IND) applications with expedited clinical development timeframes based upon the anticipated clinical benefits of earlier patient access. The observation period was completed for dose limiting toxicity (DLT) in seven patients enrolled in Cohort 2 during the second quarter of 2024. Subsequently, the safety monitoring committee (SMC) determined that the safety data observations during the DLT period supported proceeding with dose escalation to Cohort 3 and increasing the number of patients dosed at 5 mCi. Based on interactions with the FDA prior to the initiation of patient dosing in this study, which occurred in late 2023, the decision to open Cohort 3 will follow consultation and alignment with the agency. FDA interactions are ongoing with regards to the initiation of the next dosing cohort.
In June 2024, we announced multiple updates featuring our alpha-particle radiopharmaceuticals at the Society of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting (SNMMI). The data presentations highlighted favorable safety profiles and potential benefits of our lead clinical candidates. Specifically, we reported on a Phase 0 imaging trial that is evaluating the optimal imaging timepoint(s) for diagnostic/dosimetric performance of Lead-203 ([203Pb]) VMT-α-NET in neuroendocrine tumors. Investigators analyzed 48 lesions across nine patients, and the results showed that tumor uptake of [203Pb]VMT-α-NET peaked at approximately four hours post-injection, with 98% of maximum uptake observed at one hour. The results suggest that imaging with [203Pb]VMT-α-NET at four hours post-injection has the best overall diagnostic performance, followed closely by imaging at one hour.
Also at SNMMI, an investigator reported on [212Pb]VMT-α-NET planning based on [203Pb]VMT-α-NET predictive dosimetry in an investigator-sponsored trial. The investigators applied patient-specific dosimetry in a Phase 0 imaging trial (NCT05111509) of [203Pb]VMT-a-NET and in the first cohort of a Phase 1 absorbed-dose escalation study (NCT06148636) of [212Pb]VMT-α-NET. Ten patients with β-peptide receptor radionuclide therapy (PRRT)-relapsed or refractory gastroenteropancreatic (GEP)-NETs received [203Pb]VMT-α-NET (5 mCi) followed by sequential blood sampling, planar imaging and quantitative single-photon emission computed tomography/computed tomography (qSPECT/CT) imaging at 1 hour, 4 hours, 24 hours and 48 hours post-administration. Three of 10 patients received amino acid infusions while seven patients did not receive amino acids.
The dosimetry showed that the average renal doses for patients who received amino acids was 0.46±0.20 Gy/mCi, as compared to 0.56±0.16 Gy/mCi for patients who did not receive amino acids; the difference was not statistically significant. For the three patients who received [212Pb]VMT-α-NET treatment, based upon their individual dosimetry results, they were prescribed 5.3, 7.3, and 13.3 mCi cumulative activity (delivered over two cycles), respectively, to reach the cohort target renal dose of 3.5 Gy. Higher levels of targeted renal-absorbed doses are in the protocol for subsequent cohorts.
Additionally at SNMMI, the lead investigator reported on an exploratory first-in-human use of [212Pb]VMT-α-NET in adult patients with histologically confirmed metastatic NETs and medullary thyroid carcinomas in an investigator-led research study in India. The investigator reported updated safety and anti-tumor activity of [212Pb]VMT-α-NET administered at 67 µCi/kg (2.5 MBq/kg) every eight weeks in 13 patients as of the data cut-off date of May 31, 2024. All patients received prior treatments, eight of whom received prior PRRT treatment. Six patients remained eligible for further treatments as of the data cut-off date.
The investigator concluded that the toxicity profile suggests the potential for dose escalation to achieve optimal treatment responses. Confirmed tumor response per RECIST 1.1 was reported to be observed in eight of the 13 patients, while unconfirmed responses were observed in two additional patients who eventually had progressive disease and died. Median progression free survival was reported to be 16.4 months (95% confidence interval: 3.5 to NA). The investigator also reported higher absorbed doses in the tumors compared to select other tissues.
Subsequently, in October 2024, at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) in Hamburg, Germany, the investigator presented an update on a subset of the previously reported investigator-led research study in India. The cut-off date was September 15, 2024, and the study focused on 10 patients with well-differentiated GEP-NETs. These patients were treated with [212Pb]VMT-α-NET at a dosage of 67 µCi/kg (2.5 MBq/kg), with an interval of eight weeks for up to six cycles. Treatment was well tolerated with a modest and manageable adverse effect profile. Confirmed tumor response per RECIST 1.1 was observed in six of the 10 GEP-NETs patients. The investigator again concluded that the toxicity profile suggests the potential for dose escalation to achieve optimal treatment responses. Long-term survival data will mature with continued follow up.
Additionally, dosimetry estimates were collected from five of the 10 GEP-NETs patients discussed above. The results demonstrated that SPECT/CT imaging with [212Pb]VMT-α-NET showed prompt tumor accumulation, high tumor retention and rapid renal excretion in all patients. Overall, the findings suggest that post-treatment imaging of [212Pb]VMT-α-NET is feasible and can potentially serve as a valuable tool to evaluate and monitor patients through a full course of treatment.
In November 2024, at the North American Tumor Society’s NANETS Multidisciplinary NET Medical Symposium, we announced initial results from our multi-center open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive NETs who have not received prior radiopharmaceutical therapy and have shown radiological evidence of disease progression in the 12 months prior to enrollment. The data cut-off date for the presentation was October 31, 2024.
Per the study protocol, the two patients who made up Cohort 1 received administered activity of 2.5 mCi per dose regardless of body weight. Based on their respective body weights, the median administered activity per kilogram of weight was 45.5 µCi/kg per dose. The seven patients who made up Cohort 2 received administered activity of 5.0 mCi per dose regardless of body weight. Based on their respective body weights, the median administered activity per kilogram of weight was 62.1 µCi/kg per dose, ranging from 31.8 µCi/kg to 84.6 µCi/kg per dose. One patient in Cohort 2 received two doses of 84.6 µCi/kg per dose, then received the third and fourth doses at a reduced activity level of 42.4 µCi/kg per dose due to an adverse event that was determined by the investigator to be unrelated.
No DLTs were observed among any patients. No grade 4 or 5 treatment emergent or serious adverse events (AEs) were observed. Two grade 3 AEs – one case of diarrhea and one case of syncope – were observed. No decline in renal function was observed. Hematologic AEs, such as decreased lymphocyte count and anemia, were all grades 1 and 2. No treatment discontinuations due to AEs occurred.
Eight of nine patients had durable control of disease. Six of nine patients had measurable reduction of tumor volume, one of whom had a confirmed response as defined by RECIST v1.1. The patient who experienced an objective response received the first two doses at 84.6 µCi/kg per dose, then received the remaining two doses at a reduced activity level of 42.4 µCi/kg. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.
In January 2025, we announced updated interim results from this same clinical trial at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium with a data cut-off date of January 10, 2025. All nine patients in Cohort 1 and Cohort 2 had completed treatments per the study protocol, and the study team had at least one scan for all patients after their final treatments. No DLTs, grade 4 or 5 treatment emergent or serious AEs were reported since the start of the study. No new grade 3 AEs were observed aside from the two events discussed earlier. No decline in renal function was observed. Hematologic AEs, such as decreased lymphocyte count and anemia, were all grades 1 and 2. No treatment discontinuations due to AEs occurred.
Further anti-tumor activities have been observed with longer follow up, and there were two unconfirmed responses and one confirmed response as defined by RECIST v1.1 in Cohort 2. As of the January 10, 2025, data cut-off date, the patient who experienced a confirmed objective response has been in response for 17 weeks and remains in the study. This patient received the first two [212Pb]VMT-α-NET doses at administered dose of 5.0 mCi (equivalent to 84.6 µCi/kg), then received the remaining two doses at the next lower activity level of 2.5 mCi (equivalent to 42.4 µCi/kg) due to an adverse event that was determined by the investigator to be unrelated to [212Pb]VMT-α-NET.
One patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the fifth scan after their first dose, which was the first scan conducted after the end of their treatment period. This patient experienced gradual tumor regression throughout the study, with the magnitude of change meeting the criteria for response on their most recent scan. This patient received four doses of 5.0 mCi (equivalent to 68.7 µCi/kg) of [212Pb]VMT-α-NET.
A third patient was observed to experience an initial (unconfirmed (as of January 10, 2025)) response in the seventh scan after their first dose, which was the third scan conducted after the end of their treatment period. This patient received four doses of 5.0 mCi (equivalent to 31.7 µCi/kg) of [212Pb]VMT-α-NET. Gradual tumor regression was first observed in the fifth scan after their first dose, with the magnitude of change meeting the criteria for response on their most recent scan.
Five patients continued to have stable disease. One patient was deemed to have progressive disease after one dose under RECIST v1.1, by unambiguous progression of non-target lesions.
After Cohort 2 reopened for enrollment in August 2024 and through year-end 2024, an additional 11 patients were dosed. Thus, a total of 18 patients received treatment in Cohort 2 through December 31, 2024. Since the start of 2025 through the end of February 2025, an incremental 12 patients have been dosed. Thus, a total of 30 patients have received treatment in Cohort 2 as of February 28, 2025. Cohort 2 remains open for recruitment.
We are also leveraging our TAT platform with our second programproduct candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor (MC1R), a protein that is overexpressed in melanoma cancers. [212Pb]VMT01 is a TAT in development for second-line or later treatment of patients with progressive MC1R-positive metastatic melanoma.
In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors. In September 2024, we announced that on the basis of these results, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for the clinical development of [212Pb]VMT01. This study is a multi-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in patients with histologically confirmed melanoma and MC1R-positive imaging scans. Patients were required to have already received standard of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.
In October 2024, we announced initial results from the first two dosing cohorts. Three patients were enrolled in Cohort 1 (whoand received 3 mCi of [212Pb]VMT01),VMT01, while seven patients were enrolled in Cohort 2 (whoand received 5 mCi of [212Pb]VMT01).VMT01. Patients in each cohort received a median of five prior lines of systematic therapy, including a median of three prior lines of immunotherapy. No DLTs were observed among any patients, and no adverse events (AEs) led to treatment discontinuation. Treatment emergent AEs were mostly grades 1 and 2. None of the four cases of grade 3 treatment emergent AEs were deemed to be treatment related. There were no grade 4 or 5 treatment emergent AEs. No renal toxicities had been reported as of October 11, 2024 (there were no clinically significant changes in blood urea nitrogen or serum creatinine) in spite of dosimetry estimated renal radiation that approached the higher end of conventional dosing.
The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC’s recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy haswas been approvedapproved, and cohortCohort 3 at 1.5 mCi per dose iswas active and openopened for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab iswas also active and openopened for enrollment. On March 17, 2025, we announced that theThe first patient was dosedpatients in the combination cohort.and monotherapy cohorts received their first treatments in March and April 2025, respectively. As of July 31, 2025, a total of five patients had received their initial monotherapy treatments of VMT01 at 1.5 mCi per dose, once every eight weeks for up to three doses. Additionally, two patients had received VMT01 1.5 mCi with nivolumab. Both cohorts are now closed for enrollment.
In September 2025, we announced that the first patient received [212Pb]VMT01 at 3.0 mCi in combination with nivolumab, as part of a new cohort. Additionally, the [212Pb]VMT01 3.0 mCi monotherapy cohort reopened for enrollment. The SMC recommended evaluating [212Pb]VMT01 at a higher dose based on its review of five patients dosed with [212Pb]VMT01 at 1.5 mCi in the monotherapy cohort and two patients dosed with [212Pb]VMT01 at 1.5 mCi together with nivolumab.
As of February 28, 2026, a total of 10 patients had received VMT01 treatment following the re-opening of the [212Pb]VMT01 3.0 mCi monotherapy cohort and the opening of the cohort in which patients are receiving [212Pb]VMT01 at 3.0 mCi in combination with nivolumab. Six patients had received VMT01 at 3.0 mCi in combination with nivolumab. Four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts are now closed for enrollment.
By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 would have had the opportunity for at least 24 weeks of follow up after their initial doses, which is sufficient time to receive at least one scan after their full treatment (up to three doses every eight weeks).
Tumor stroma cells do not typically express cancer-specific markers like SSTR2 or MC1R. Fibroblast activation protein alpha (FAP-α) is primarily expressed on tumor stroma cells, but also on some cancer cells. FAP-α, a pan-cancer target, is a pan-cancerprotein target that is highlyabundantly expressed in manycertain cancers.cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. Our in-house discovery team discovered PSV359, a novel cyclic peptide targeting human FAP-α, via phage display methods. We believe PSV359 is an optimized peptide with potential best-in-class characteristics that has been demonstrated in preclinical models. In March 2024, we released the first-in-human clinical single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging which suggested very favorable tumor targeting and retention by the PSV359 compound,compound while clearing from normal organs rapidly and completely.
In October 2024, we announced first-in-human SPECT/CT images of [203Pb]PSV359 from an independent investigator revealed strong tumor uptake, fast clearance through the renal system, low accumulation in normal organs,organs and long tumor retention in three patients with FAP-α expressing cancers.
Preclinical results for PSV359 were presented during the SNMMISociety of Nuclear Medicine and Molecular Imaging 2024 Annual Meeting and the EANM37th Annual Congress of the European Association of Nuclear Medicine meetings in June and October 2024, respectively. Researchers presented a novel cyclic peptide targeting human FAP-α, which was discovered by us via phage display methods. FAP-α is a protein abundantly expressed in certain cancer cells as well as cancer-associated fibroblasts in tumor lesions and involved in promoting disease progression. The peptide was conjugated to a lead (Pb)-specific chelator via a molecular linker to form a novel construct, PSV359. The purpose of this study was to evaluate the in vitro and in vivo performance of [203/212Pb]PSV359 in preclinical xenograft models. Overall, strong anti-tumor clinical activity of [212Pb]PSV359 was found in both HT1080-human FAP-α (FAP-α on cancer cells) and U87MG (FAP-α in stromal tissues) xenograft models.
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212Pb]PSV359. As of February 28, 2026, two patients have been treated with [212Pb]PSV359 at 2.5 mCi (Cohort 1) and six patients have been treated with [212Pb]PSV359 at 5.0 mCi (Cohort 2), for a total of eight patients. By late 2026, these patients would have had the opportunity for at least 32 weeks of follow up after their initial doses, which is sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks). Activation activities are underway for additional sites.
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. We expect to initiate dosing in mid 2025.
In January 2024, we announced that we have a license agreement with Mayo Clinic for the rights to Mayo Clinic’s prostate-specific membrane antigen (PSMA) Alpha-PET DoubLET platform technology for the treatment of PSMA-expressing cancers, with an initial focus on prostate. This radiopharmaceutical platform provides detailed PET imaging-based diagnosis and dosimetry using long-lived Copper-64 for imaging and alpha-particle targeted therapies using 212Pb. Preclinical studies are ongoing to assess whether this new molecular entity meets the hurdle for progressing into the clinic.
Also inIn January 2024, we entered into an exclusiveexclusive, in-licensingworldwide oflicense agreement with Stony Brook University’sUniversity Cuburbit[7]uril-admantane (CB7-Adma) pre-targeting platform which coversfor the global intellectual property rights to suchthe Cuburbit[7]uril-admantane (CB7-Adma) pre-targeting platform. Pre-targeting using the CB7-Adma platform involves two steps. First, an antibody that binds with high specificity to a cancer-specific protein is administered via intravenous injection. This antibody is chemically modified to include the CB7 chemical entity and accumulates over time at the tumor site. Then, a radionuclide held tightly by our proprietary chelator attached to an Adma group is administered. The Adma group binds to the CB7 group that was previously attached to the cancerous cells with specificity, delivering radiation dose selectively to the tumor sites. Central to this innovation is CB7-Adma (host-guest) complex formation, driving the interaction between the antibody and radioligand. The chosen host-guest pair, CB7-Adma, has demonstrated promising in vivo stability, modularity and low immunogenicity. The platform’s potential was validated through in vivo profiling of ligands, employing a CB7-modified carcinoembryonic antigen targeting antibody. The agreement with Stony Brook University will expire on the later of the expiration date of the last to expire licensed patents or 20 years from the date of the first sale of a product utilizing the intellectual property. Preclinical optimization of this platform is underway, and initial targeting antibodies are being identified for further investigation.
Intellectual Property (IP)
We continue to strengthen our intellectual property portfolio in support of our platform technologies, product candidates and other programs. Our patent covering our VMT-α-GEN 212Pb-generation technology was issued in the U.S. in March 2026, and the corresponding European patent application has been allowed. Our AlphaPRIME™ 212Pb-generation technology is patented in the U.S., and related patent applications have been allowed in China and Europe. We believe these developments further enhance the geographic scope and depth of protection for our core radiopharmaceutical technologies and manufacturing platforms.
Two patents have recently been granted on key assets for which we have exclusive licenses from the University of Iowa. US 12,128,115, granted by the United States Patent and Trademark Office on October 29, 2024, is directed to the use of compounds comprising PSC for performing chelating reaction with divalent metals, including Pb2+, and the use of such compounds for diagnosing and treating diseases. AU 2017281940, granted by IP Australia on October 31, 2024, is directed to melanoma-targeting radiopharmaceutical compounds and the use of such compounds for treating melanoma. In addition, since the end of 2024, a patent has been issued in Australia which pertains to the creation of radiopharmaceutical compounds using lead-specific chelators. The full term of this patent expires in April 2039. We believe these patents further strengthen our IP portfolio.
We have had recurring losses since inception. We expect our expenses to increase in connection with our ongoing activities, particularly as we advance and expand preclinical activities, clinical trials and potential commercialization of our programproduct candidates. Our costs are also expected to increase as we:
continue the development of our clinical-stage assets, including VMT01, VMT-α-NET-NET, VMT01 and PSV359;
continue the development of our product candidates and other program candidatesprograms;
continue to initiate and progress other supporting studies required for regulatory approval of our programproduct candidates;
initiate preclinical studies and clinical trials for any additional indications for our current programproduct candidates and any future programproduct candidates that we may pursue;
continue to build our portfolio of programproduct candidates through the acquisition or in-license of additional programproduct candidates or technologies;
pursue regulatory approvals for our current and future programproduct candidates that successfully complete clinical trials;
continue to build our manufacturing capabilitiescapabilities, including potential expansion of our manufacturing footprint;
support our marketing and distribution infrastructure to commercialize any future programproduct candidates for which we may obtain marketing approval; and hire additional clinical, medical, development and other personnel.
As of December 31, 2024,2025, we had cash, cash equivalents and short-term investments of $226.9$144.7 million. 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 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 plannedclinical operationsmilestones and operational investments for at least the next 12 months from the date the consolidated financial statements in this report were issued and into late 2026.2027. Monthly operating expenses are budgeted to increase for research and development and general and administrative expenses as management works to implement its strategy to advance our clinical assets in their clinical trials and to progress our preclinical assets towards clinical trials. Management anticipates a significant increase in expenses, particularly in research and development, as we undertake these activities.
Manufacturing Equipmentand Supply
We assemble and manufacture our finished radiopharmaceutical candidates by chelating or trapping an atom of 212Pb within a specialized chelator or chemical “cage” and connecting the 212Pb within its cage to the targeting peptide with our linker technology. For clinical supply, we intend to use a combination of third-party contract manufacturing organizations, or CMOs, and our own manufacturing sites complying with the FDA’s current good manufacturing practices, or CGMP, to manufacture and distribute our doses. For the drug precursors and isotopes that comprise our TAT platform, a variety of clinical phase manufacturers have been engaged and utilized. We procure chelator-modified peptide precursors from peptide manufacturers who are capable of producing clinical phase precursor material.
In May 2025, we entered into a supply agreement with the U.S. Department of Energy (DOE) under which we will purchase Thorium-228 from the DOE during 2025 and 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.
On September 18,In 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical productsproduct candidates including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables.
What changed in the latest 10-Q
Risk Factors
In the ordinary course of business, we are exposed to a variety of risks, any of which have affected or could materially adversely affect our business, financial condition, and results of operations. The market price of our securities could decline, possibly significantly or permanently, if one or more of these risks and uncertainties occur. Before you make a decision to buy our securities, in addition to the risks and uncertainties discussed above under “Cautionary Statement Regarding Forward-Looking Statements,” you should carefully consider the specific risk factors set forth in the “Risk Factors” section in the 2025 Form 10-K. We may also face other risks and uncertainties that are not presently known, are not currently believed to be material, or are not yet identified because they are common to all businesses. There have been no material changes to the risk factors disclosed in Part I, Item 1A of the 2025 Form 10-K.
No wording changes found in this section.
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Management's Discussion & Analysis (MD&A)
New heading “Bamzireotide Navoxetan (VMT-α-NET)”
New heading “Lapemelanotide Zapixetar (VMT01)”
Largest changes
“In July 2026, we announced that the European Commission has granted orphan medicinal product designation for [212Pb]VMT-α-NET for the treatment of gastroenteropancreatic NETs. The designation follows a positive opinion from the Committee of Orphan Medicinal Products of the European Medicines Agency.”see in full comparison
“Updated data was presented at ASCO with a DCO date of March 25, 2026. One new response was observed early in the 3.0 mCi monotherapy cohort, in addition to a previously reported response, for a total of two responders out of the seven treated patients. Six out of the seven patients (86%) in the 3.0 mCi monotherapy cohort experienced stable disease or partial response, four patients completed all three treatments with 24 weeks or more of follow-up after their first treatment, and two remained on treatment and in study. …”see in full comparison
Insee in full comparisonOctober2025 andApril2026, we entered into agreements with a general contractor pursuant to which weexpectcommitted to pay approximately$34.4$53.3 million. Thefirstagreementsagreement isare for the general contractor to make building modifications at ourfacilityfacilities in the metropolitan areas of Chicago, IL,metropolitanandareaLos Angeles, CA, and to prepare for the installation of some of the Comecer manufacturing equipment and associated clean rooms atthatthosesite. We expect to complete construction at that site in 2026. The second agreement is for the general contractor to order long-lead time items and to prepare to make modifications to our facility in the Los Angeles, CA metropolitan area, including for the eventual installation of some of the Comecer manufacturing equipment and associated clean rooms at that site.sites. We anticipate incurring additional spending with this general contractor,particularlyand actual costs may differ. We expect to complete construction at the Chicago-area site inconnectionearlywith2027theandbuild out of our facility inat the LosAngeles,Angeles-areaCAsitemetropolitanbyarea.the end of 2027.
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212Pb]PSV359.see in full comparisonAsData from Cohort 1 (2.5 mCi) and Cohort 2 (5.0 mCi) was presented at ASCO with a DCO date ofAprilDecember30,24,2026,2025,twowhichpatientsdemonstratedhave been treated withthat [212Pb]PSV359atwas2.5wellmCitolerated(Cohortwith1),no DLTs andseventreatmentpatientsemergenthave been treated with [212Pb]PSV359AEs at5.0gradesmCi1(Cohortand 2),for a total of nine patients. By late 2026, these patients will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks).only.
Full comparison: every changed paragraph (51)
You should read the following discussion and analysis of our financial condition and results of operations together with (i) the unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q for the quarter ended MarchJune 31,30, 2026 (Form 10-Q), (ii) our audited consolidated financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 16, 2026 (2025 Form 10-K) and (iii) other filings we have made with the SEC. As discussed under the heading “Cautionary Note Regarding Forward-Looking Statements,” this discussion contains forward-looking statements that reflect our plans, estimates and beliefs, and involves numerous risks and uncertainties, including but not limited to those described under the heading “Risk Factors” in the 2025 Form 10-K that may cause actual results to differ materially from those described in or implied by any forward-looking statements. Unless the context otherwise requires, references in thesethis notessection to the “Company,” “Perspective,” “we,” “us” and “our,our” except where the context requires otherwise, refer to Perspective Therapeutics, Inc. and its subsidiaries.
We are a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body. We have proprietary technology that utilizes the alpha-emitting isotope Lead-212 (212Pb) to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. We are also developing complementary imaging diagnosticstechniques that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This theranostic approach enables thevisualization ability to seeof the specific tumor and thensubsequent treat it totreatment, potentially improveimproving efficacy and minimizeminimizing toxicity.
Our neuroendocrine tumor (VMT-α-NET), melanoma (VMT01) and solid tumor (PSV359) programsWe are inadvancing Phasea 1/2aportfolio imagingof andclinical-stage therapy trialsprograms in the U.S.U.S., including VMT-α-NET (neuroendocrine tumors), VMT01 (melanoma) and PSV359 (solid tumors). We are growingexpanding our regional network offinished drug product candidate finishingsupply facilities,network, enabled by our proprietary 224Ra/212Pb generator,generator platform used to delivermanufacture clinical drug product candidates, to supply the delivery of patient-ready drug product candidates for clinical trials andand, if approved, commercial operations.
Bamzireotide Navoxetan (VMT-α-NET)
VMT-α-NET
We designed VMT-α-NET to target and deliver 212Pb to cancer-specific receptors on tumor cells expressing somatostatin receptor type 2 (SSTR2), a protein that is overexpressed in neuroendocrine tumors (NETs) and other cancers.cancers, and to deliver the alpha-emitting radioisotope 212Pb to tumor sites expressing SSTR2. We are conducting a multi-center, open-label, dose-escalation and dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET is a targeted alpha therapy (TAT) in development for patients with unresectable or metastatic SSTR2-expressingSSTR2-positive tumors who have not previously received peptide-targetedprior radiopharmaceutical therapy. NETs are a group of rare, heterogeneous tumors that develop in different organs of the body and arise from specialized cells in the neuroendocrine system.therapies.
We initially dosed two patients in Cohort 1 (treated with four doses at 2.5 mCi per dose) and seven patients in Cohort 2 (treated with four doses at 5.0 mCi per dose) of ourthe Phase 1/2a clinical trial (NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-expressing NETs,study, regardless of body weight. Subsequent review for dose-limiting toxicity (DLT) during the safety observation period in the seven patients enrolled in Cohort 2 by the Safety Monitoring Committee (SMC) led the SMC to recommend escalating further in a third cohort and enrolling additional patients at 5.0 mCi to better understand efficacy and safety. During the second quarter of 2025, enrollment for Cohort 2 closed with an additional 39 patients having received at least one treatment, for a total of 46 patients including the seven who were enrolled for DLT observation. By late 2026, all 46 patients in Cohort 2 will have had the opportunity for at least 60 weeks of follow-up, which is expected to inform the Phase 3 study design.
In late June 2025, we announced the opening of Cohort 3 in which patients are receiving up to four fixed administered doses of [212Pb]VMT-α-NET at 6.0 mCi every eight weeks if they weigh more than 60 kg (133 lb), or 100μCi/kg of body weight if they weigh less than or equal to 60 kg. Eight Cohort 3 patients then commenced treatment with VMT-α-NET and contributed to the DLT assessment by the SMC. The DLT assessment is now complete, and we are cleared to treat more patients at this dose. As of April 30, 2026, a total of 20 patients havehad been treated in Cohort 3. This cohort iswas nowfully closed to enrollment. By late 2026, the eight patients initially enrolled for DLT assessment will have had the opportunity for at least 48 weeks of follow-up since beginning treatment.enrolled.
CohortIn 4May is2026, nowwe openannounced forthat recruitment.the first patient was treated with [212Pb]VMT-α-NET in a fourth cohort. This cohort explores optimizing a 20 mCi cumulative dose by front-loading, with 6.0 mCi in the first dose, 5.0 mCi in the second dose, 5.0 mCi in the third dose, and 4.0 mCi in the fourth dose. The purpose of this dosing regimen is to determine whether front-loading could change response kinetics and improve response rate at lower cumulative doses. Additionally, administering a higher dose while there are more tumors could result in a kidney-sparing effect and improved safety.
We have an allowance for enrollment of patients with NETs whose disease originated in the lung (of which small cell lung cancer is a subset), pheochromocytoma and paraganglioma NETs, and SSTR2+ meningioma. In June 2026, we announced the initiation of, and the first patient dosed in, a new cohort intended to evaluate the safety, dosimetry and preliminary anti-tumor activity of [212Pb]VMT-α-NET in patients with meningioma (LEMONαDE). The initiation of the meningioma cohort reflects our broader strategy to evaluate [212Pb]VMT-α-NET across SSTR2-expressing tumor types beyond neuroendocrine tumors.
During the dose-finding phase of the study, we enrolled primarily NET patients whose disease originated in the pancreas or the digestive tract. We have an allowance for enrollment of NET patients whose disease originated in the lung (of which small cell lung cancer is a subset), pheochromocytoma and paraganglioma NETs, and SSTR2+ meningioma.
We opened a proof-of-concept cohort of meningioma patients. To date, there is no approved systematic therapy for this disease. The unmet medical need may support an expedited development path.
Updated interim data from the study, as of a data cut-off (DCO) date of March 4, 2026, were presented at the American Association for Cancer Research Annual Meeting 2026 (AACR 2026). The safety findings based on 64 patients (two patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi) and 16 patients in Cohort 3 (6.0 mCi)) showed no reports of DLTs, serious renal complications, treatment-related discontinuations, serious renal complications, dysphagia or clinically significant treatment-related myelosuppression. Grade 3 or higher treatment-emergent adverse events were reported in 23 patients (36%). One of these patients, who was enrolled in Cohort 3, experienced a transient decrease in lymphocyte count on the cusp between Grades 3 and 4. The site subsequently determined this event to be a Grade 3 event. This event was transient and resolved without medical intervention. The patient completed the full course of [212Pb]VMT-α-NET treatment, consisting of four treatments without interruption, and remains on study. There were no Grade 4 or 5 events. No additional patients experienced serious adverse events (SAEs) since the most recent update at the 2026 ASCO Gastrointestinal Cancers Symposium (ASCO-GI 2026), with none of the five SAEs deemed related to the study medication.
Updated data was presented at the 2026 American Society of Clinical Oncology Annual Meeting (ASCO), which took place from May 29 through June 2, 2026. The presentation highlighted that the deepening of response continued to be observed following the AACR 2026 and ESMO presentations. The ASCO DCO date of April 17, 2026 represented an additional six weeks of follow-up after the prior update at AACR 2026 in April 2026 and approximately 31 weeks after ESMO 2025 in October 2025.
As of July 31, 2026, a total of 76 NETs patients across four cohorts and one meningioma patient had been treated with [212Pb]VMT-α-NET. Updated data on NETs patients enrolled in the trial will be presented at the ESMO 2026 conference on October 23, 2026.
In July 2026, we announced that the European Commission has granted orphan medicinal product designation for [212Pb]VMT-α-NET for the treatment of gastroenteropancreatic NETs. The designation follows a positive opinion from the Committee of Orphan Medicinal Products of the European Medicines Agency.
We continue to advance [212Pb]VMT-α-NET toward a Phase 3 study in NETs, with regulatory engagement ongoing and clinical site activation targeted around year-end 2026, subject to regulatory feedback and finalization of the study protocol.
Lapemelanotide Zapixetar (VMT01)
As of April 30, 2026, the first 23 patients in Cohort 2 have had the opportunity for at least 60 weeks of follow-up since beginning treatment, and by late 2026, we expect all 46 patients in Cohort 2 would have had the opportunity for at least 60 weeks of follow-up since beginning treatment.
We believe our clinical data package positions us for meaningful regulatory engagement in 2026 to align on the path forward.
VMT01
We are also leveraging our TAT platform with our product candidate, VMT01, which is currently in Phase 1/2a clinical trials. We designed VMT01 to target and deliver 212Pb to tumor sites expressing melanocortin 1 receptor (MC1R), a protein that iscan be overexpressed in metastatic melanoma cancers. [212Pb]VMT01We isare conducting a TATmulti-center, open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) in development for second-line or later treatment of patients with progressivehistologically confirmed melanoma and MC1R-positive metastaticimaging melanoma.scans.
In preclinical experiments [212Pb]VMT01 demonstrated efficacy via two distinct mechanisms of action: direct cell killing at high radiation doses and through immunostimulatory low-dose induction of immune-mediated cell death. Efficacy was augmented by immune checkpoint inhibitors. In September 2024, we announced that on the basis of these results, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for the clinical development of [212Pb]VMT01.VMT01 Thisfor studythe isdiagnosis aand multi-center,treatment open-label dose escalation, dose expansion study (clinicaltrials.gov identifier NCT05655312) inof patients with histologicallyunresectable confirmedor metastatic melanoma and MC1R-positive imaging scans. Patients were required towho have alreadydemonstrated receivedMC1R standardtumor of care. Eligible patients may receive up to three treatments with [212Pb]VMT01, eight weeks apart.expression.
The SMC reviewed these findings and recommended exploring a lower dose level of 1.5 mCi per dose, both as a single agent and in combination with the anti-PD-1 antibody, nivolumab. The SMC’s recommendation would allow for the monotherapy and combination cohorts to proceed concurrently. An amendment to further explore lower dose levels for monotherapy was approved, and Cohort 3 at 1.5 mCi per dose was opened for enrollment. The combination cohort at 1.5 mCi per dose with nivolumab was also opened for enrollment. The first patients in the combination and monotherapy cohorts received their first treatments in March and April 2025, respectively. As of July 31, 2025, a total of five patients had received their initial monotherapy treatments of VMT01 at 1.5 mCi per dose, once every eight weeks for up to three doses. Additionally, two patients had received VMT01 1.5 mCi with nivolumab. Both cohorts arewere nowfully closed for enrollment.enrolled.
As of February 28, 2026, a total of 10 patients had received VMT01 treatment following the re-opening of the [212Pb]VMT01 3.0 mCi monotherapy cohort and the opening of the cohort in which patients are receiving [212Pb]VMT01 at 3.0 mCi in combination with nivolumab. Six patients had received VMT01 at 3.0 mCi in combination with nivolumab. Four patients had received 3.0 mCi of VMT01 as monotherapy, in addition to the three patients who received this monotherapy dose in late 2023. Both cohorts arewere nowfully closed for enrollment.enrolled.
Updated data was presented at ASCO with a DCO date of March 25, 2026. One new response was observed early in the 3.0 mCi monotherapy cohort, in addition to a previously reported response, for a total of two responders out of the seven treated patients. Six out of the seven patients (86%) in the 3.0 mCi monotherapy cohort experienced stable disease or partial response, four patients completed all three treatments with 24 weeks or more of follow-up after their first treatment, and two remained on treatment and in study. Patients continued to demonstrate that [212Pb]VMT01 was well tolerated with no DLTs, no discontinuations due to AEs, and no grade 4 or 5 treatment emergent AEs. Eight (30%) patients out of a total of 27 patients treated experienced grade 3 treatment emergent AEs.
By late 2026, six patients in the cohort receiving [212Pb]VMT01 at 3.0 mCi in combination with nivolumab are expected to reach at least 24 weeks of follow-up.
By late 2026, the 10 patients who had received VMT01 3.0 mCi treatment since the initiation or re-opening of these cohorts in September 2025 have had the opportunity for at least 24 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to three doses every eight weeks).
We filed an IND application for PSV359 in December 2024, and we received a “study may proceed” letter (i.e., approval to conduct the trial) from the FDA in the first quarter of 2025. In April 2025, we announced the first patient was treated with [212Pb]PSV359. AsData from Cohort 1 (2.5 mCi) and Cohort 2 (5.0 mCi) was presented at ASCO with a DCO date of AprilDecember 30,24, 2026,2025, twowhich patientsdemonstrated have been treated withthat [212Pb]PSV359 atwas 2.5well mCitolerated (Cohortwith 1),no DLTs and seventreatment patientsemergent have been treated with [212Pb]PSV359AEs at 5.0grades mCi1 (Cohortand 2), for a total of nine patients. By late 2026, these patients will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to have completed at least one scan after the full course of treatment (up to four doses every eight weeks).only.
Cohort 3 was cleared to open following the SMC’s review of safety data from Cohort 2. Patients in Cohort 3 are receiving up to four fixed administered doses of PSV359 at 6.0 mCi every eight weeks. The first patient was treated in May 2026. Cohort 3 fully enrolled eight patients during the second quarter of 2026 and is closed.
As of July 31, 2026, 17 patients had received PSV359 monotherapy across the three cohorts. The next clinical update is planned in 2027.
We have been cleared to open Cohort 3, which is now open for recruitment, following the SMC’s review of safety data from Cohort 2.
In May 2026, we presented an FIH image for PSV594, designed to target and deliver 212Pb to tumor sites expressing the Cholecystokinincholecystokinin 2 Receptorreceptor (CCK2R), which is expressed across a range of hard-to-treat cancers. The targeting moiety may also be radiolabeled with 203Pb or 68Ga to detect CCK2R expression in-vivo. Preclinical data and FIH imagesbiodistribution suggestobservations thesupport targetingcontinued moietypre-IND hasdevelopment clean,of precise tumor uptake with limited kidney retention, which may result in a desirable therapeutic index.PSV594.
We continue to strengthen our intellectual property portfolio in support of our platform technologies, product candidates and other programs. Our patent covering theCCK2R-targeted VMT-α-GENradiopharmaceutical 212Pb-generation technologycompounds was issued in the U.S. in MarchJune 2026, and the corresponding European patent application has been allowed.2026. Our AlphaPRIME™FAP-α-targeted 212Pb-generationradiopharmaceutical technologycompounds iswere patented in the U.S., China andin Europe.July 2026. We believe these developments further enhance the geographic scope and depth of protection for our core radiopharmaceutical technologies and manufacturing platforms.
As of MarchJune 31,30, 2026, we had cash, cash equivalents and short-term investments of $270.9$236.9 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments for at least the next 12 months from the date the condensed consolidated financial statements in this report were issued and into late 2027. Management anticipates a significant increase in expenses, particularly in research and development, as it works to implement its strategy to advance our clinical assets in their clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials.
In May 2025 and May 2026, we entered into supply agreements with the U.S. Department of Energy (DOE) under which we will purchase Thorium-228 from the DOE between 2025 and 2027. As of March 31, 2026, weWe have met and been invoiced for our minimum purchase requirements under the May 2025 supply agreement. The May 2026 supply agreement includes a “take-or-pay” provision pursuant to which we are committed to purchasing approximately $9.9 million of Thorium-228 during the term of the agreement.
In 2024, we entered into a Master Equipment and Services Agreement (MESA) and statements of work (SOWs) thereunder with Comecer SpA (Comecer), pursuant to which we agreed to purchase from Comecer manufacturing equipment for the production of our radiopharmaceutical programproduct candidates including, but not limited to, isotope processing hot cells and production suites and related equipment (collectively, the Deliverables) and services for installation and validation of the Deliverables at several of our production facilities in the United States. The aggregate consideration for such equipment and services pursuant to the MESA and SOWs is approximately €49.0 million payable in cash, excluding certain incidental costs, such as taxes, customs and duties, local transport, insurance and rigging. We may also elect to purchase certain additional equipment and services pursuant to the SOWs. The MESA provides for the payment of certain amounts in installments over the course of the production, installation and validation of the Deliverables.
Also in 2024, we acquired the assets and associated lease of Lantheus’ radiopharmaceutical manufacturing facility in Somerset, NJ. Soon after the acquisition, we began the onboarding and operationalization processes and, in October 2024, we achieved the first shipment and patient dosing from our Somerset facility. With three manufacturing suites that can meet CGMP requirements, the Somerset facility is expected to have the capacity to meet future clinical trial and commercial demandsdemand at major cancer treatment centers throughout the Northeastern U.S. An existing production suite in Somerset ishas beingbeen upgraded to support Phase 3 activities, with installation completed and commissioning targeted for completionthe byend mid-2026.of 2026. A fourth production suite has also been installed and completed, and we expect it to be operational in 2026.
In October 2025 and April 2026, we entered into agreements with a general contractor pursuant to which we expectcommitted to pay approximately $34.4$53.3 million. The firstagreements agreement isare for the general contractor to make building modifications at our facilityfacilities in the metropolitan areas of Chicago, IL, metropolitanand areaLos Angeles, CA, and to prepare for the installation of some of the Comecer manufacturing equipment and associated clean rooms at thatthose site. We expect to complete construction at that site in 2026. The second agreement is for the general contractor to order long-lead time items and to prepare to make modifications to our facility in the Los Angeles, CA metropolitan area, including for the eventual installation of some of the Comecer manufacturing equipment and associated clean rooms at that site.sites. We anticipate incurring additional spending with this general contractor, particularlyand actual costs may differ. We expect to complete construction at the Chicago-area site in connectionearly with2027 theand build out of our facility inat the Los Angeles,Angeles-area CAsite metropolitanby area.the end of 2027.
As of MarchJune 31,30, 2026, there have been no material changes to any of the critical accounting policies and estimates contained therein.
Research and development expenses were $21.4$21.5 million for the three months ended MarchJune 31,30, 2026, compared to $14.3$16.6 million for the three months ended MarchJune 31,30, 2025, an increase of $7.0$4.9 million. Research and development expenses were $42.9 million for the six months ended June 30, 2026, compared to $31.0 million for the six months ended June 30, 2025, an increase of $12.0 million. The increase in research and development expenses was primarily related to higher personnel costs, including share-based compensation, due to additional headcount to support our ongoing clinical trials, including chemistry, manufacturing, and control work related to our clinical product candidates, as well as increased spending on contract development and manufacturing organizations, clinical site activities, drug programs and delivery, pipeline studies and consulting.
Management believes that research and development expenses will continue to increase as we continue to invest in the development of novel radiopharmaceutical drugs and programproduct candidates and expand our manufacturing capabilities. We are investing in equipment and modifications for the three buildings we acquired in 2024 located in the Houston, TX, Chicago, IL, and Los Angeles, CA, metropolitan areas. Upon completion, we intend to use the buildings to manufacture our programproduct candidates.
We are also actively strengthening our current manufacturing capabilities to support the clinical supply of radiopharmaceuticals through the expansion of clinical production lines at our locations in Coralville, IA, and Somerset, NJ. In Coralville, we built a second production suite that became operational in 2025. The Somerset facility, with its three manufacturing suites that can meet CGMP requirements, is expected to have the capacity to meet future clinical trial and commercial demandsdemand at major cancer treatment centers throughout the Northeastern U.S. An existing production suite in Somerset ishas beingbeen upgraded to support Phase 3 activities, with installation completed and commissioning targeted for completionthe byend mid-2026.of 2026. A fourth production suite has also been installed and completed, and we expect it to be operational in 2026.
Management believes that the cost of certain raw materials used in the production of our novel radiopharmaceutical drugs and programproduct candidates may increase in the coming years, including as a result of increased demand for materials required for the production of radiopharmaceuticals. We are also currently evaluating how potential U.S. and international trade policies, including tariffs, might impact our costs for supplies, equipment and materials used in the development and production of our TAT drug programproduct candidates. We currently source much of the raw materials that are used to produce our programproduct candidates in the U.S. Some equipment and other materials that will be used at our manufacturing sites is sourced from outside the U.S. Based on our analysis of recently announced tariffs, we do not expect to experience any material incremental tariff-related cost impacts in 2026. We will continue to monitor policy developments related to tariffs and the implementation dates of new tariffs, as well as potential opportunities to source materials and equipment from alternative suppliers, as we continue to evaluate the potential impacts of tariffs.
General and administrative expenses were $7.0 million for the three months ended March 31, 2026, compared to $7.8 million for the three months ended MarchJune 31,30, 2026, compared to $7.7 million for the three months ended June 30, 2025, an increase of $0.1 million. The increase in general and administrative expenses was primarily related to higher personnel costs, including share-based compensation, partially offset by decreased fees for professional services and fees related to operating as a public company. General and administrative expenses were $14.8 million for the six months ended June 30, 2026, compared to $15.6 million for the six months ended June 30, 2025, a decrease of $0.9$0.8 million. The decrease in general and administrative expenses was primarily due to decreased fees for professional and consulting services and fees related to operating as a public company, partially offset by increased personnel costs.
Operating Activities: The increase of $9.9$10.6 million in net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026, compared to the same period in 2025 was primarily due to an increase of $8.0$13.3 million in net lossloss, partially offset by an increase of $2.4 million in non-cash activities and $3.1$0.3 million due to changes in operating assets and liabilities, partially offset by an increase of $1.3 million in non-cash activities.liabilities.
Investing Activities: The increase of $104.0$93.2 million in net cash used in investing activities for the threesix months ended MarchJune 31,30, 2026, as compared to the same period in 2025 was primarily due to an increase of $127.7$118.9 million in purchases of short-term investments and a $2.2$15.4 million increase in additions to property and equipment, partially offset by an increase of $25.9$41.0 million in maturities of short-term investments.
Financing Activities: Net cash provided by financing activities of $164.4$164.5 million and $10.0$10.1 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, were primarily related to the proceeds received from the sale of Common Stock and pre-funded warrants pursuant to the 2026 Offering (defined below) and the 2024 ATM Agreement (defined below), respectively.
continue the development of our clinical-stage assets, including bamzireotide navoxetan (VMT-α-NET,-NET), lapemelanotide zapixetar (VMT01) and PSV359;
At MarchJune 31,30, 2026, we had cash, cash equivalents and short-term investments of $270.9$236.9 million. We believe our cash, cash equivalents and short-term investments will be sufficient to fund our current planned clinical milestones and operational investments into late 2027. Management anticipates a significant increase in expenses, particularly in research and development, as it works to implement its strategy to advance our clinical assets in their clinical trials, expand our manufacturing capabilities and progress our preclinical assets towards clinical trials.
We presented our other commitments and contingencies in the 2025 Form 10-K. There have been no material changes outside of the ordinary course of business in those obligations during the threesix months ended MarchJune 31,30, 2026, other than those disclosed in Note 10, Commitments and Contingencies, to the condensed consolidated financial statements in this Form 10-Q.
CATX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 5 filings (2 insiders, 5 trade dates, 517,889 shares, about $1.6M). Net open-market shares: -517,889 (purchases minus sales); net value about -$1.6M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-04 | Lantheus Alpha Therapy, Llc |
Open-market sale | 167,149 | $3.15 | $526.5K |
| 2026-09-03 | Lantheus Alpha Therapy, Llc |
Open-market sale | 80,783 | $3.11 | $251.2K |
| 2026-09-02 | Lantheus Holdings, Inc. |
Open-market sale | 42,129 | $3.11 | $131.0K |
| 2026-09-01 | Lantheus Alpha Therapy, Llc |
Open-market sale | 35,769 | $3.12 | $111.6K |
| 2026-09-01 | Lantheus Holdings, Inc. |
Open-market sale | 35,769 | $3.12 | $111.6K |
| 2026-08-31 | Lantheus Alpha Therapy, Llc |
Open-market sale | 78,145 | $3.14 | $245.4K |
| 2026-08-31 | Lantheus Holdings, Inc. |
Open-market sale | 78,145 | $3.14 | $245.4K |
Well-known investors holding CATX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 4,911,855 | $16.7M | 0.01% | Added 21% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 3,805,739 | $13.0M | 0.01% | Added 7% |
| Two Sigma Investments | 2026-06-30 | 1,556,451 | $5.3M | 0.0% | Added 55% |
| Renaissance Technologies | 2026-06-30 | 59,133 | $201.6K | 0.0% | New position |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 27,998 | $95.5K | 0.0% | Added 5% |