Perspective Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 16, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 16, 2026
CATX$0.84+6.5%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-03-26.
0000950170-25-045242
Item 1A. RISK FACTORSCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-16.
0000728387-26-000004
Item 1A. RISK FACTORSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 258 previous paragraphs and 265 current paragraphs.
110 unchanged; 129 reworded; 23 added; 17 removed; 2 previous and 3 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (23)
Current report
the expansion of our manufacturing capabilities and the costs and timing associated therewith;
Current report
The net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparisons of our results of operations may not be a good indication of our future performance.
Current report
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.
Current report
the suitability and location of clinical trial sites;
Current report
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.
Current report
the results of clinical trials may not demonstrate statistically robust and/or clinically meaningful results sufficient to support approval;
Current report
the FDA or comparable foreign regulatory authorities may require additional data or impose conditions that differ from prior guidance or interactions;
Current report
the FDA or comparable regulatory authorities may find that our manufacturing process(es) and or data integrity systems are inadequate during pre-approval inspection and/or routine inspection; and
Current report
The risk of a cybersecurity incident or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that store or facilitate access to confidential information increases the risk of cybersecurity data security incidents, which could impact the confidentiality, integrity and availability of confidential information or other data we maintain or data maintained on our behalf. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data cybersecurity incident, and we rely on commercially available systems, software, tools and monitoring to provide security for our information technology systems and infrastructure and the processing, transmission and storage of digital information. However, there can be no assurance that our efforts to protect data and systems will prevent service interruption or the loss of confidential or other critical information from our or third-party providers’ information technology and infrastructure. The costs and operational consequences to us of maintaining reasonable security measures or of responding to cybersecurity incidents, including disruption, degradation, or manipulation of systems, networks or technology, or implementing remediation measures could be significant. Furthermore, threat actors may use AI tools to automate and enhance cybersecurity attacks against us. We use software and platforms designed to detect such cybersecurity threats, but these threats could become more sophisticated and harder to detect and counteract, which may pose significant risks to our data security and systems. Additionally, while we have implemented security measures that we believe are appropriate and continue to enhance cybersecurity protections, a regulator could deem our security measures not to be appropriate given the lack of prescriptive measures in certain data protection laws. Increased regulation of data collection, use and retention practices, including self-regulation and industry standards, changes in existing laws and regulations, enactment of new laws and regulations, increased enforcement activity, and changes in interpretation of laws, could increase our cost of compliance and operation, limit our ability to grow our business or otherwise harm our business.
Current report
To the extent that any disruption or cybersecurity incident results or appears to result in an interruption or loss of or damage to our information technology systems or infrastructure, or inappropriate disclosure of confidential information, we could incur material reputational harm, penalties, regulatory fines or scrutiny, liabilities, legal claims, and/or mandated changes in our business practices. Furthermore, if our information technology systems and infrastructure, or those of third parties on which we rely, suffer severe damage, disruption or shutdown and our business continuity plans do not effectively resolve the issues in a timely manner, we could experience delays in reporting our financial results, violate our loan covenants, miss reporting deadlines, and the development of our product candidates could be delayed. Additionally, if such interruption or cybersecurity incident were to occur or appear to occur, it could result in a material disruption of our development programs. For example, the loss or alteration of clinical trial data from planned, completed or ongoing clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data and reduce trial participants’ or patients’ trust in us. A significant cybersecurity incident may also deter new clinical trial participants from participating in our trials. Such events could also lead to an interruption in our supply chain for the manufacturing of clinical and commercial drug substance and drug product, as well as related materials, and could significantly impact development and commercialization timelines and capabilities.
Current report
In the EU, an important and foreseeable example of reform measures is the forthcoming EU pharmaceutical legislation revision. In April 2023, the European Commission published a proposal to reform the current European pharmaceutical legislative framework. The legislative proposal would change European Union pharmaceutical law with respect to, among other topics, regulatory data exclusivity, orphan market exclusivity, environmental risk assessment, medicines shortages. In December 2025, the European Commission, European Parliament and the Council reached an agreement on pharmaceutical reform. The final text of the reform proposal is expected to be endorsed and published in the first or second quarter of 2026 and, after a transition period, the new legislation is expected to start to apply from mid-2028.
Current report
patent applications may not result in issued patents;
Current report
any patents that are issued or in-licensed may be challenged in administrative or judicial proceedings, including opposition, inter partes review, post-grant review, reexamination, or other proceedings, and may be invalidated, narrowed, modified, revoked, circumvented, found unenforceable, or otherwise fail to provide meaningful protection or competitive advantage;
Current report
patent laws and regulations in jurisdictions outside the U.S. States may provide less protection to patent holders than the laws of the U.S., thereby permitting competitors to develop and commercialize competing products in such jurisdictions;
Current report
patent laws, regulations, and their interpretation in the U.S. and other jurisdictions are subject to change, which could adversely affect our ability to obtain or enforce patent protection; and
Current report
we may become involved in litigation or other proceedings to protect or enforce our patents or those of our licensors, which could be costly, time consuming, divert management’s attention, and may not result in favorable outcomes.
Current report
In addition, we may become subject to claims that we or our employees, consultants, advisors or independent contractors have inadvertently or otherwise improperly used or disclosed trade secrets or other proprietary information of their former employers or other third parties. Any such claims, regardless of merit, could result in costly litigation, require us to modify our technology or business practices, or otherwise adversely affect our business.
Current report
third parties may independently develop identical, similar or alternative technologies, products, compositions or methods of use;
Current report
the disclosures in our patent applications may not satisfy the statutory requirements for patentability, including novelty, nonobviousness, written description, enablement or adequate support for the claimed subject matter;
Current report
we may not seek or obtain patent protection in jurisdictions that may ultimately represent a significant business opportunity or provide a viable commercial market;
Current report
our compositions, manufacturing methods or methods of use may ultimately be determined to be unpatentable;
Current report
Potential patent litigation could be costly and disruptive and may have an adverse effect on our business, financial condition and results of operations. We operate in an industry characterized by extensive intellectual property litigation and administrative proceedings. Potential claims may include challenges to the validity, enforceability, ownership or scope of our patents or other intellectual property rights as well as allegations that our programs, product candidates, technologies or methods of us infringe, misappropriate or otherwise violate patents or other intellectual property rights held by competitors or other third parties. An unfavorable outcome in any such proceeding could result in, among other things, the loss, narrowing, or invalidation of our patent rights; the inability to obtain or maintain regulatory approvals; injunctions preventing the development, manufacture, or commercialization of our product candidates; the need to obtain licenses on unfavorable terms, if at all; or the payment of substantial damages, including treble damages and attorneys’ fees in the event of a finding of willful infringement. Any such outcome could adversely affect our competitive position, business prospects, financial condition, and results of operations.
Current report
suspend, delay, abandon or redesign an affected product candidate technology or process to avoid infringement;
Removed paragraphs (17)
Previous report
seek regulatory approvals for our program candidates that successfully complete clinical trials;
Previous report
establish a sales, marketing and distribution infrastructure to commercialize any program candidates for which we may obtain regulatory approval;
Previous report
seek to identify and validate additional program candidates;
Previous report
acquire or in-license other program candidates and technologies;
Previous report
the quality or stability of the program candidate may fall below acceptable standards.
Previous report
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a program candidate is safe and effective for its proposed indication;
Previous report
we may be unable to demonstrate that a program candidate’s clinical and other benefits outweigh its safety risks;
Previous report
the FDA or comparable foreign regulatory authorities may fail to hold to previous agreements or commitments;
Previous report
the potential and perceived advantages of program candidates over alternative treatments;
Previous report
The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments, and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.
Previous report
In the EU, an important and foreseeable example of reform measures is the forthcoming EU pharmaceutical legislation revision. In April 2023, the European Commission published a proposal to reform the current European pharmaceutical legislative framework. The proposal intends to reduce the regulatory data protection and orphan market exclusivity periods. It is currently uncertain if the proposal will be adopted in its current form, and it is uncertain if and when the revised legislation would enter into force. In April 2024, the European Parliament adopted its position on the Commission proposal. Next, the Council must adopt its position. Once the Council has adopted its position, three-party negotiations between the Commission, Parliament and Council will take place. Adoption of the new legislation is not expected to take place before 2026.
Previous report
patent laws and regulations in the United States and other jurisdictions and judicial interpretation of such laws and regulations are subject to change; and
Previous report
our compositions and methods may not be patentable;
Previous report
Potential patent litigation could be costly and disruptive and may have an adverse effect on our financial condition and results of operations. We operate in an industry characterized by extensive patent litigation. Potential patent claims include challenges to the coverage and validity of our patents or processes as well as allegations that our programs infringe patents held by competitors or other third parties. A loss in any of these types of cases could result in a loss of patent protection or the ability to market our programs, which could lead to a significant loss of sales, or otherwise materially affect future results of operations.
Previous report
abandon an infringing program candidate or redesign our programs or processes to avoid infringement;
Previous report
Our business could be negatively impacted by corporate citizenship and sustainability matters. There is an increased focus from certain investors, employees and other stakeholders concerning corporate citizenship and sustainability matters, which include environmental concerns and social investments. We could fail to meet, or be perceived to fail to meet, the expectations of these certain investors, employees and other stakeholders concerning corporate citizenship and sustainability matters, thereby resulting in a negative impact to our business. As we continue to integrate corporate citizenship, sustainability and strong governance practices throughout our organization, we could also be criticized for the scope or nature of our initiatives or goals. We could also encounter reactions from governmental actors (such as anti-environmental, social and governance legislation or retaliatory legislative treatment), which could have a material adverse effect on us.
Previous report
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. In addition, negative, inappropriate or inaccurate posts or comments about us or our program candidates on social media internet sites could quickly and irreversible damage our reputation, image and goodwill. Further, the accidental or intentional disclosure of non-public sensitive information by our workforce or others through media channels could lead to information loss or could lead to legal or regulatory issues for us. In addition, there is a risk of a fraudulent third-party hijacking our information technology systems without our knowledge to access our confidential documents or to use our company name, logo or brand without authorization. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face restrictive regulatory actions or incur other harm and costs to our business.
Reworded paragraphs (129)
Previous wording
We are a clinical-stage biopharmaceutical company and have a limited operating history upon which to base an investment decision. Since the merger of Isoray and Viewpoint in 2023, we have engaged primarily in research and development activities related to VMT-α-NET, VMT01 and our other program candidates, 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 program candidates. The successful commercialization of any of our program candidates will require us to perform a variety of functions, including:
Current wording
We are a clinical-stage biopharmaceutical company and have a limited operating history upon which to base an investment decision. Since the merger of Isoray and Viewpoint in 2023, we have engaged primarily in research and development activities related to VMT-α-NET, VMT01, PSV359 and our other programs, have not generated any revenue from product sales other than our discontinued brachytherapy business and have incurred significant net losses. We have not received regulatory approval to market any of our current product candidates.
Previous wording
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 program candidates, if approved;
Current wording
manufacturing products in compliance with applicable federal, state and local regulations and maintaining supply and manufacturing relationships with third parties that are both commercially feasible and meet regulatory requirements and our supply needs in sufficient quantities to meet market demand for product candidates, if approved;
Previous wording
obtaining reimbursement or pricing for our program candidates that supports profitability; and
Current wording
obtaining reimbursement or pricing for our product candidates that supports profitability; and
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managing our spending and cash requirements as our expenses are expected to continue to increase due to research and preclinical work, clinical trials, regulatory approvals, commercialization and maintaining our intellectual property portfolio.
Current wording
managing our spending and cash requirements as our expenses are expected to continue to increase as we continue to invest in the development of our product candidates and other radiopharmaceutical programs, expand our manufacturing capabilities and undertake commercialization activities.
Previous wording
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, VMT01 and our other program candidates. These operations provide a limited basis for our stockholders and prospective investors to assess our ability to complete development of or commercialize VMT-α-NET, VMT01 or any of our other program candidates given the risks and uncertainties frequently encountered in new and rapidly evolving fields and the advisability of investing in our securities.
Current wording
Our operations since the merger of Isoray and Viewpoint in 2023 have been limited to organizing and staffing, acquiring, developing and securing the proprietary rights for, and undertaking preclinical development and clinical trials for VMT-α-NET, VMT01, PSV359 and our other programs. These operations provide a limited basis for our stockholders and prospective investors to assess our ability to complete development of or commercialize VMT-α-NET, VMT01, PSV359 or any of our other programs given the risks and uncertainties frequently encountered in new and rapidly evolving fields and the advisability of investing in our securities.
Previous wording
Even if one or more of the program candidates is approved for marketing, we anticipate incurring significant costs associated with commercialization of such program candidate(s). Portions of our current pipeline of program candidates have been in-licensed from third parties, which make 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 program candidates. Additionally, if we are not able to gain market acceptance for our program 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.
Current wording
Even if one or more of our product candidates is approved for marketing, we anticipate incurring significant costs associated with commercialization of such product candidate(s). Portions of our current pipeline of product candidates have been in-licensed from third parties, which makes the commercial sale of such in-licensed products potentially subject to additional royalty and milestone payments to such third parties. We will also have to continue to expand our manufacturing capabilities to support expanded manufacturing, development and potential commercialization of our product candidates. Additionally, if we are not able to gain market acceptance for our product candidates, or if the market is too small or competitive to generate revenue from the sale of any approved products, we may never become profitable.
Previous wording
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 as of December 31, 2024. We believe that our cash, cash equivalents and short-term investments as of December 31, 2024 will be sufficient to fund our current planned operations into late 2026. 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 program candidates and technologies in our pipeline. In particular, our funding needs may vary depending on a number of factors including:
Current wording
We will require substantial additional capital to fund our operations. Additional funds may be dilutive to shareholders or impose operational restrictions. Further, if additional capital is not available, we may need to delay, limit or eliminate our research, development and commercialization programs and modify our business strategy. Our principal sources of liquidity are cash, cash equivalents and short-term investments, which were $144.7 million as of December 31, 2025. In February 2026, we announced the closing of an underwritten offering of securities with gross proceeds of $175.0 million before deducting underwriting discounts and commissions and other offering-related expenses. We believe that our cash, cash equivalents and short-term investments as of December 31, 2025, together with the net proceeds from the February 2026 offering, will be sufficient to fund our current clinical milestones and operational investments into late 2027. However, changing circumstances may cause us to consume capital faster than we currently anticipate. Within the next several years, substantial additional funds will be required to continue with the active development of our clinical programs as well as the other preclinical programs and technologies in our pipeline.
Previous wording
the extent to which we continue the development of our program candidates or form licensing arrangements to advance our program candidates;
Current wording
the extent to which we continue the development of our product candidates or form licensing arrangements to advance our product candidates;
Previous wording
our decisions to in-license or acquire additional programs, additional program candidates or technology for development;
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our decisions to in-license or acquire additional programs, additional product candidates or technology for development;
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our ability to attract and retain development or commercialization partners, and their effectiveness in carrying out the development and ultimate commercialization of one or more of our program candidates;
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our ability to attract and retain development or commercialization partners, and their effectiveness in carrying out the development and ultimate commercialization of one or more of our product candidates;
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whether batches of program candidates that we manufacture fail to meet specifications resulting in clinical trial delays and investigational and remanufacturing costs;
Current wording
whether batches of product candidates that we manufacture fail to meet specifications resulting in clinical trial delays and investigational and remanufacturing costs;
Previous wording
the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and program candidates;
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the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology, product candidates and other programs;
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competing programs, program candidates and technological and market developments; and
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competing programs, product candidates and technological and market developments; and
Previous wording
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 program candidates, our technologies or future revenue streams or to grant licenses or sell assets on terms that may not be favorable to us.
Current wording
Debt financing, if available, will result in payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any debt financing or additional equity that we raise may contain terms, such as liquidation and other preferences, which are not favorable to us or our existing shareholders. If we raise additional funds through corporate collaborations, partnerships or other strategic transactions, it may be necessary for us to relinquish valuable rights to our product candidates or other programs, our technologies or future revenue streams or to grant licenses or sell assets on terms that may not be favorable to us.
Previous wording
significantly delay, scale back or discontinue the development or commercialization of one or more of our program candidates or one or more of our research and development initiatives;
Current wording
significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or other programs or one or more of our research and development initiatives;
Previous wording
seek collaborators for one or more of our program candidates or one or more of our research and development initiatives at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;
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seek collaborators for one or more of our product candidates or other programs or one or more of our research and development initiatives at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;
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sell or license on unfavorable terms our rights to one or more of our technologies, program candidates or research and development initiatives that we otherwise would seek to develop or commercialize ourselves;
Current wording
sell or license on unfavorable terms our rights to one or more of our technologies, product candidates or other programs or research and development initiatives that we otherwise would seek to develop or commercialize ourselves;
Previous wording
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, 2024 and have not received any revenues other than from our brachytherapy business, which was divested in April 2024. From inception to December 31, 2024, we have an accumulated deficit of approximately $231.7 million. Investment in drug development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a program 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 program 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.
Current wording
We have incurred losses in nearly every year since our inception, and we anticipate that we will not achieve profits for the foreseeable future. To date, we have incurred losses nearly every year since inception through the year ended December 31, 2025 and have not generated any revenues other than from our brachytherapy business, which was divested in April 2024. From inception to December 31, 2025, we have an accumulated deficit of approximately $334.8 million. Investment in drug development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. We continue to incur significant research, development and other expenses related to our ongoing operations, including development of our product candidates. We do not expect to achieve profits until such time as product sales, milestone payments and royalty payments, if any, generate sufficient revenues to fund our continuing operations. We cannot predict if we will ever achieve profitability and, if we do, we may not be able to remain consistently profitable or increase our profitability.
Previous wording
continue our research and preclinical and clinical development of our program candidates;
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continue our research and preclinical and clinical development of our product candidates and other programs;
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initiate additional preclinical, clinical or other studies or trials for our program candidates;
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initiate additional preclinical, clinical or other studies or trials for our product candidates and other programs;
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create additional infrastructure to support our research, product development and planned future commercialization efforts; and
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create additional infrastructure to support our research, product development, manufacturing and planned future commercialization efforts; and
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Our program 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 program 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 program 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 program 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.
Current wording
Our product candidates are in early stages of development and must go through clinical trials, which are very expensive, time consuming and difficult to design and implement. The outcomes of clinical trials are uncertain, and delays in the completion or termination of any clinical trial of our product candidates could harm our business, financial condition and prospects. Our research and development programs are at an early stage of development. We must demonstrate our product candidates’ safety and efficacy in humans through extensive clinical testing, which is expensive and time consuming and requires specialized knowledge and expertise. Clinical trials are also expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The clinical trial process is also time consuming, and the outcome is not certain. We estimate that clinical trials of our product candidates will take multiple years to complete. Failure can occur at any stage of a clinical trial, and we could encounter problems that cause us to abandon or repeat clinical trials.
Previous wording
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.
Current wording
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.
Previous wording
We currently have three clinical trials in Phase 1/2a for VMT-α-NET, PSV359 and VMT01. All three trials are registered with ClinicalTrials.gov. For VMT-α-NET and VMT01, we have completed dosing our first cohorts 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.
Current wording
We currently have three clinical trials in Phase 1/2a for VMT-α-NET, VMT01 and PSV359. All three trials are registered with ClinicalTrials.gov. We have completed dosing our initial cohorts for each of these trials and are currently enrolling patients in additional cohorts. VMT-α-NET and VMT01 have also received Fast Track designation, which allows for rapid communication with the FDA on clinical trial development plans and findings. The approved Phase 1/2a trial for VMT-α-NET is entitled “A Phase 1/2a First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors.” The approved Phase 1/2a trial for VMT01 is entitled “A Phase 1/2a, First-In-Human, Multi-Center Dose Escalation and Dose Expansion Study of [203/212Pb]VMT01 Receptor-Targeted, Image Guided Alpha-Particle Therapy in Patients with Previously Treated Unresectable or Metastatic Melanoma.” The approved Phase 1/2a study for PSV359 is entitled “A Phase I/IIa Image-Guided, Alpha-Particle Therapy Study of [203Pb]Pb-PSV359 and [212Pb]Pb-PSV359 in Patients with Solid Tumors that are Known to be Fibroblast Activation Protein (FAP)-Positive.” All three trials are multi-center.
Previous wording
As with most pharmaceutical products, use of our program 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 program candidates may be observed at any time, including in clinical trials or when a program is commercialized. Undesirable side effects caused by our program 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 program 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 program 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 program 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.
Current wording
As with most pharmaceutical products, use of our product candidates could be associated with side effects or adverse events, which can vary in severity and frequency. Side effects or adverse events associated with the use of our product candidates may be observed at any time, including in clinical trials or when a product is commercialized. Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other foreign authorities. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects, toxicity or other safety issues, and could require us to perform additional studies or halt development or sale of these product candidates or expose us to product liability lawsuits that will harm our business. In such an event, we may be required by regulatory agencies to conduct additional animal or human studies regarding the safety and efficacy of our product candidates that we have not planned or anticipated, or our studies could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. There can be no assurance that we will resolve any issues related to any product-related adverse events to the satisfaction of the FDA or any other regulatory agency in a timely manner, if ever, which could harm our business, prospects and financial condition.
Previous wording
We rely on single vendors to provide supplies and services used in the development and production of our alpha-particle therapies. We obtain our supply of Thorium-228 from a single supplier, the U.S. Department of Energy (DoE). 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 DoE for the purchase of Thorium-228. From time to time, we may enter into additional purchase orders with the DoE for the purchase of Thorium-228. Additionally, we currently utilize one vendor for the manufacture of resin chromatography columns that are used in our 212 Pb generators. We also rely on a single vendor to assemble and load isotopes into the generators that are used to extract 212 Pb for use in the doses for our clinical trials. Reliance on any single supplier or vendor increases the risks associated with obtaining raw materials and necessary services. Should the agreement with the DoE be cancelled or terminated for any reason, we may be unable to obtain an alternative supply of Thorium-228 at a comparable cost, which may have a material adverse impact on our ability to further develop or produce our alpha-particle therapies. Should the agreement with the vendor that manufactures resin chromatography columns that are used in our generators or the agreement with the vendor that assembles and loads isotopes in our generators be cancelled or terminated for any reason, or should either such vendor fail to perform adequately under its agreement with us, our ability to produce doses for our clinical trials may be materially delayed or impaired.
Current wording
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 212 Pb) from a single supplier, the U.S. Department of Energy (DOE). In January 2021, we entered into a 10-year contract with the DOE for the purchase of Thorium-228. In May 2025, we entered into a supply agreement with the DOE under which we will purchase Thorium-228 from the DOE during 2025 and early 2026. The supply agreement includes a “take-or-pay” provision pursuant to which we are committed to purchasing approximately $8.4 million of Thorium-228 during the term of the agreement. From time to time, we may enter into additional supply agreements with the DOE for the purchase of Thorium-228. Additionally, we currently utilize one vendor for the manufacture of resin chromatography columns that are used in our 212 Pb generators. We also rely on a single vendor to assemble and load isotopes into the generators that are used to extract 212 Pb for use in the doses for our clinical trials. Reliance on any single supplier or vendor increases the risks associated with obtaining raw materials and necessary services. Should the agreement with the DOE be cancelled or terminated for any reason, we may be unable to obtain an alternative supply of Thorium-228 at a comparable cost, which may have a material adverse impact on our ability to further develop or produce our alpha-particle therapies. Should the agreement with the vendor that manufactures resin chromatography columns that are used in our generators or the agreement with the vendor that assembles and loads isotopes in our generators be cancelled or terminated for any reason, or should either such vendor fail to perform adequately under its agreement with us, our ability to produce doses for our clinical trials may be materially delayed or impaired.
Previous wording
Our clinical trials will compete with other clinical trials for program candidates that are in the same therapeutic areas as our program 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. We may also encounter difficulties finding clinical trial sites at which to conduct our trials.
Current wording
Our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates. This competition will reduce the number and types of patients and qualified clinical investigators available to us because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors, or clinical trial sites may not allow us to conduct our clinical trial at such site if competing trials are already being conducted there. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial sites. We may also encounter difficulties finding suitable clinical trial sites at which to conduct our trials.
Previous wording
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 program candidates and may result in additional net losses.
Current wording
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of these clinical trials and adversely affect our ability to advance the development of our product candidates and may result in additional net losses.
Previous wording
Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any program 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 program 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 program 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.
Current wording
Because the results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials, if any, or receive regulatory approval. Pharmaceutical development has inherent risk. We will be required to demonstrate through well-controlled clinical trials that our product candidates are effective with a favorable benefit-risk profile for use in their target indications before we can seek regulatory approvals for their commercial sale. Success in preclinical studies or early clinical trials does not mean that later clinical trials will be successful, as product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing, and clinical data are often susceptible to varying interpretations or analyses. We also may need to conduct additional clinical trials that are not currently anticipated. Companies frequently suffer significant setbacks in advanced clinical trials, even after earlier clinical trials have shown promising results.
Previous wording
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 program candidates. Although our Phase 1/2a clinical trials are ongoing, the completion of clinical trials can be delayed for a variety of reasons, including:
Current wording
Delays in the commencement, execution or completion of our clinical trials could result in increased costs and delay our ability to pursue regulatory approval and commercialization of our product candidates. Although our Phase 1/2a clinical trials are ongoing, the completion of clinical trials can be delayed for a variety of reasons, including:
Previous wording
obtaining sufficient quantities of investigational product for our program candidates for use in clinical trials;
Current wording
obtaining sufficient quantities of investigational product for our product candidates for use in clinical trials;
Previous wording
identifying, recruiting and enrolling patients to participate in a clinical trial, including delays and/or interruptions resulting from geopolitical actions, disease or public health epidemics, or natural disasters;
Current wording
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;
Previous wording
inability to identify and maintain a sufficient number of trial sites;
Current wording
inability to identify and maintain a sufficient number of suitable trial sites;
Previous wording
reliance on third-party suppliers for the clinical trial supply of program 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;
Current wording
reliance on third-party suppliers relating to the clinical trial supply of product candidates and failure by our third-party suppliers to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;
Previous wording
Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our program 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 program candidate.
Current wording
Any delays in the commencement of our clinical trials will delay our ability to pursue regulatory approval for our product candidates. In addition, many of the factors that cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate.
Previous wording
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 program 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.
Current wording
We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive, or the trials are not well designed. Regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Clinical trials must be conducted in accordance with current Good Clinical Practices (CGMPs) or other applicable foreign government guidelines governing the design, safety monitoring, quality assurance and ethical considerations associated with clinical studies. Clinical trials are subject to oversight by the FDA, other foreign governmental agencies and IRBs at the study sites where the clinical trials are conducted. In addition, clinical trials must be conducted with product candidates produced in accordance with applicable CGMPs, which are the FDA’s regulations governing the design, monitoring and control of manufacturing processes and facilities. In the EU, clinical trials should be conducted in accordance with guidelines on good clinical practices and in accordance with the Clinical Trials Regulation. Under the Clinical Trials Regulation, sponsors must submit one application for a new trial to the online Clinical Trials Information System for approval to run a trial in several European countries. Prior to authorization, the clinical trial shall be subject to ethics review performed by an ethics committee, in accordance with the law of the concerned EU member state.
Previous wording
the program candidate may have unforeseen adverse side effects;
Current wording
the product candidate may have unforeseen adverse side effects;
Previous wording
the program candidate may not appear to be more effective than current therapies; or
Current wording
the product candidate may not appear to be more effective than current therapies; or
Previous wording
If we elect or are forced to suspend or terminate a clinical trial for VMT-α-NET, VMT01, PSV359 or of any other program candidates, the commercial prospects for that program candidate will be harmed and our ability to generate product revenue from that program 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 program candidate and could substantially increase the costs of commercializing our program candidates and impair our ability to generate revenue from the commercialization of these program candidates, either by us or by our collaboration partners.
Current wording
If we elect or are forced to suspend or terminate a clinical trial for VMT-α-NET, VMT01, PSV359 or of any other product candidates, the commercial prospects for that product candidate will be harmed and our ability to generate product revenue from that product candidate may be delayed or eliminated. Furthermore, any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product candidate and could substantially increase the costs of commercializing our product candidates and impair our ability to generate revenue from the commercialization of these product candidates, either by us or by our collaboration partners.
Previous wording
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 program candidates from applicable regulatory authorities, we will not be able to market and sell those program 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 (TPD), the European Medicines Agency (EMA) and the European Commission (EC), is unpredictable but typically takes many years following the commencement 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 program candidates depends on obtaining the final results of required clinical testing and non-clinical testing, including characterization of the manufactured components of our program candidates and validation of our manufacturing processes, that meet applicable regulatory standards. We have not submitted an NDA, a marketing application or a similar filing to obtain regulatory approval for any program candidate in any jurisdiction, and it is possible that none of our existing program candidates or any program candidates we may seek to develop in the future will ever obtain regulatory approval.
Current wording
The approval processes of regulatory authorities are lengthy, time consuming, expensive and inherently unpredictable; if we experience unanticipated delays or are unable to obtain approval for our product candidates from applicable regulatory authorities, we will not be able to market and sell those product candidates in those countries or regions, and our business will be substantially harmed. The time required to obtain approval by the FDA in the United States and by comparable health authorities in foreign markets, including Health Canada’s Therapeutic Products Directorate (Health Canada), the European Medicines Agency (EMA) and the European Commission (EC), is unpredictable but typically takes many years from the initiation of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the programs involved and the discretion of the regulatory authorities. Our ability to obtain marketing approval for our product candidates depends on generating sufficient clinical and nonclinical data, including adequate characterization and control of manufacturing processes and validation activities, that meet applicable regulatory standards. We have not submitted an NDA, a marketing application or a similar filing to obtain regulatory approval for any product candidate in any jurisdiction, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.
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Current report — wording carried from elsewhere
The successful commercialization of any of our product candidates will require us to perform a variety of functions, including:
Current report — wording carried from elsewhere
In particular, our funding needs may vary depending on a number of factors including:
Current report — wording carried from elsewhere
Many of these laws provide for substantial penalties for noncompliance. The shifting regulatory environment, along with the requirement to comply with multiple jurisdictions with different compliance and/or reporting requirements, increases the possibility that a company may inadvertently run afoul of one or more laws.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Although we believe that as of the date of this Annual Report, we have adequate insurance to address anticipated potential liabilities associated with product liability, any unforeseen product liability exposure in excess of, or outside the scope of, such insurance coverage could adversely affect our financial condition and operating results. Any such claim brought against us, with or without merit, could result in significant damage to our business. Insurance coverage is expensive and difficult to obtain and, although we currently have a