{"url_path":"/sec/atnm/10-q/2026/item-1a","section_key":"item-1a","section_title":"Item 1A RISK FACTORS**","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-08","source_url":"https://www.sec.gov/Archives/edgar/data/1388320/0001213900-26-053980-index.html","accession_number":"0001213900-26-053980","cik":"0001388320","ticker":"ATNM","issuer_name":"Actinium Pharmaceuticals, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1388320/0001213900-26-053980-index.html","primary_entity_key":"0001388320","primary_entity_name":"Actinium Pharmaceuticals, Inc."},"word_count":28645,"has_tables":true,"body_markdown":"**ITEM 1A. RISK FACTORS**\n\n** **\n\n*In analyzing our company,\nyou should consider carefully the following risk factors, together with all of the other information included in this Quarterly Report\non Form 10-Q. Factors that could cause or contribute to differences in our actual results include those discussed in the following\nsubsection, as well as those discussed above in “Management’s Discussion and Analysis of Financial Condition and Results of\nOperations” and in our Annual Report on Form 10-K for the year ended December 31, 2025. Each of the following risk factors, either\nalone or taken together, could adversely affect our business, operating results and financial condition, as well as adversely affect the\nvalue of an investment in our company. The risks and uncertainties described below are not the only ones we face. Additional risks not\ncurrently known to us, or other factors not perceived by us to present significant risks to our business at this time also may impair\nour business operations.*\n\n** **\n\n39\n\n \n\n** **\n\n**Summary of Risk Factors**\n\n** **\n\nWe are providing the following summary of the risk factors contained\nin this Quarterly Report on Form 10-Q to enhance the readability and accessibility of our risk factor disclosures. We encourage you to\ncarefully review the full risk factors contained in this Quarterly Report on Form 10-Q in their entirety for additional information regarding\nthe material factors that make an investment in our securities speculative or risky. These risks and uncertainties include, but are not\nlimited to, the following:\n\n \n\n \n●\nWe are a clinical-stage company and have generated no revenue from commercial sales to date;\n\n \n \n \n\n \n●\nWe have incurred net losses every year since our inception and anticipate that we will continue to incur net losses in the future;\n\n \n \n \n\n \n●\nIf we fail to obtain additional financing, we will be unable to continue or complete our product development or product commercialization and you will likely lose your entire investment;\n\n \n\n \n●\nWe are highly dependent on the clinical, regulatory and commercial success of ATNM-400, Actimab-A, Iomab-ACT, and other pipeline candidates which we may never achieve;\n\n \n \n \n\n \n●\nWe are highly dependent on our key personnel, and the demand for talent in the biotechnology industry is highly competitive; if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement or execute our business strategy;\n\n \n\n \n●\nWe continuously evaluate our business strategy and may modify our strategy as necessary to respond to developments in our business and other factors, and any such modification such as a divestiture, spin-off, spin-out, merger or acquisition, if not successful, could have a material adverse effect on our business, financial condition, and results of operations;\n\n \n\n \n●\nWe may expand our business through the acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’ ownership interests in our company;  \n\n \n \n \n\n \n●\nOur business could be adversely affected by the effects of future health epidemics;\n\n \n \n \n\n \n●\nOur business is subject to cybersecurity risk;\n\n \n \n \n\n \n●\nWe have not demonstrated that any of our products are safe or effective for any indication and will continue to expend substantial time and resources on clinical development before any of our current or future product candidates will be eligible for FDA approval, if ever;\n\n \n \n \n\n \n●\nOur clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay regulatory approval and commercialization;\n\n \n\n \n●\nPreliminary, Interim, and “top-line” data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data;\n\n \n\n \n●\nHealthcare legislative reform measures intended to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the regulation of the U.S. healthcare system could have a material adverse effect on our business, future revenue, if any, and results of operations;\n\n \n\n \n●\nChanges in the healthcare industry and in healthcare spending could adversely affect our grant-funded clinical programs, business, financial condition and results of operations;\n\n \n\n \n●\nWe may rely on third parties to conduct certain aspects of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates;\n\n \n\n40\n\n \n\n \n\n \n●\nWe currently depend on single third-party manufacturers to produce our preclinical and clinical trial drug supplies. Any disruption in the operations of our current third-party manufacturers, or other third-party manufacturers we may engage in the future, could adversely affect our business and results of operations;\n\n \n\n \n●\nOur product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences;\n\n \n \n \n\n \n●\nDisruptions at the FDA and other government agencies caused by leadership changes, changes to regulatory approach, layoffs, funding shortages or global health concerns could negatively impact our business;\n\n \n \n \n\n \n●\nOur ability to advance clinical development of trials under our CRADA, obtain regulatory interactions/approvals, or secure government-funded grants may be delayed or disrupted by federal government shutdowns such as the shutdown that began October 1, 2025 and ended on November 12, 2025, as it curtailed operations of key agencies such as the FDA and the National Institutes of Health (“NIH”);\n\n \n \n \n\n \n●\nOur patent position is highly uncertain and involves complex legal and factual questions;\n\n \n \n \n\n \n●\nThe use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials;\n\n \n \n \n\n \n●\nCertain provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest; and\n\n \n \n \n\n \n●\nOur ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.\n\n \n\n**Risks Related to Our Business**\n\n \n\n**We are a clinical-stage company and have\ngenerated no revenue from commercial sales to date.**\n\n** **\n\nWe are a clinical-stage biopharmaceutical\ncompany with a limited operating history. We have no products approved for commercial sale and have not generated any revenue from product\nsales to date. We will encounter risks and difficulties frequently experienced by early-stage companies in rapidly evolving fields. If\nwe do not address these risks successfully, our business will suffer.\n\n** **\n\n**We have incurred net losses every year since\nour inception and anticipate that we will continue to incur net losses in the future.**\n\n** **\n\nWe are not profitable and have incurred losses in each period since\nour inception. As of March 31, 2026 and December 31, 2025, we had an accumulated deficit of $415.2 million and $409.7 million, respectively.\nWe reported a net loss of $5.5 million and $15.9 million for the three months ended March 31, 2026 and 2025, respectively. We expect to\ncontinue to operate at a net loss as we continue our research and development efforts, continue to conduct clinical trials and develop\nmanufacturing, sales, marketing and distribution capabilities. There can be no assurance that the products under development by us will\nbe approved for sale in the United States or elsewhere. Furthermore, there can be no assurance that if such products are approved, they\nwill be successfully commercialized, which would have an adverse effect on our business prospects, financial condition and results of\noperation.\n\n \n\n41\n\n \n\n \n\n**If we fail to obtain additional financing,\nwe will be unable to continue or complete our product development and you will likely lose your entire investment.**\n\n \n\nAs of the date of filing this\nreport, we expect that our existing resources will be sufficient to fund our planned operations for more than 12 months following the\ndate of this report.\n\n \n\nOur business or operations\nmay change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required\nto maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or\notherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred\ncancer treatment modalities. However, we may not be able to secure funding when we need it or on favorable terms or indeed on any terms.\nIn addition, from time to time, we may not be able to secure enough capital in a timely enough manner which may cause the generation of\na going-concern opinion from our auditors which can and may impair our stock market valuation and also our ability to finance on favorable\nterms or indeed on any terms.\n\n \n\nTo raise additional capital,\nwe may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock.\nWe cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share that is equal\nto or greater than the price per share paid by investors, and investors purchasing shares or other securities in the future could have\nrights superior to existing stockholders.\n\n \n\nIf we cannot raise adequate\nfunds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical\nstudies, or future operations. We may also be required to obtain funds through arrangements with collaborators, which arrangements may\nrequire us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights\nto future product candidates or certain major geographic markets. We may further have to license our technology to others. This could\nresult in sharing revenues which we might otherwise have retained for ourselves. Any of these actions may harm our business, financial\ncondition, and results of operations.\n\n \n\nThe amount of funding we will\nneed depends on many factors, including the progress, timing and scope of our product development programs; the progress, timing and scope\nof our preclinical studies and clinical trials; the time and cost necessary to obtain regulatory approvals; the time and cost necessary\nto further develop manufacturing processes and arrange for contract manufacturing; our ability to enter into and maintain collaborative,\nlicensing and other commercial relationships; and our partners’ commitment of time and resources to the development and commercialization\nof our products.\n\n \n\n**We have limited access to the capital markets\nand even if we can raise additional funding, we may be required to do so on unfavorable terms.**\n\n \n\nWe have limited access to\nthe capital markets to raise funds. The capital markets have been unpredictable in the recent past for development stage radiopharmaceutical\nand other biotechnology companies and unprofitable companies such as ours. In addition, it is generally difficult for development-stage\ncompanies to raise capital under current market conditions. The amount of capital that a company such as ours is able to raise often depends\non variables that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If\nwe are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds\nare not available on acceptable terms, or at all, our business, including our technology licenses, results of operations, financial condition\nand our continued viability will be materially adversely affected.\n\n \n\n**We are highly dependent on the clinical, regulatory and commercial\nsuccess of ATNM-400, Actimab-A, Iomab-ACT, and other pipeline candidates which we may never achieve.**\n\n** **\n\nNone of the drug candidates\nwe are developing, or have developed, have received regulatory approval. Based on the current status of our pipeline candidates, it will\nlikely take several years and additional clinical studies before we can seek approval for any drug candidate.\n\n \n\nATNM-400 is currently being studied preclinically and has not yet been\nstudied in human subjects. There can be no assurances that we will advance ATNM-400 into clinical trials and even if we are successful\nin doing so, our preclinical results to date may not translate with human subjects. Our Actimab-A drug candidate was studied in a Phase\n2 clinical trial as a monotherapy, and we are now studying it in combination with other therapies. We believe we have aligned with the\nFDA on a Phase 2/3 trial that is intended to support a BLA filing. There can be no assurance that the Phase 2 portion of the trial will\nbe successful and support advancing to the Phase 3 portion of the trial. In addition, our Iomab-ACT drug candidate has only been studied\nin a limited number of human subjects in a Phase 1 trial with a novel CAR-T therapy. While we believe the initial results from this trial\nwere encouraging, there can be no assurance that future results with Iomab-ACT from the commercial CAR-T trial at UTSW or sickle cell\nconditioning trial at Columbia will be positive.\n\n \n\n42\n\n \n\n \n\nAs for Iomab-B in particular,\nas previously disclosed, we completed the Phase 3 SIERRA trial (Study of Iomab-B in Elderly Relapsed or Refractory AML) and presented\nthe trial results in February 2023, which were expected to support a BLA filing. The SIERRA trial met the primary endpoint of dCR with\nstatistical significance (p-value<0.0001) but did not meet the secondary endpoint in achieving a statistically significant improvement\nin OS in the intent to treat population. On August 5, 2024, we announced that the FDA determined that the SIERRA trial alone is not adequate\nto support a BLA filing and is requiring an additional randomized head-to-head clinical trial to demonstrate an OS benefit in an intent\nto treat population. Further, the FDA is also requiring an additional dose optimization trial to calculate the dose of Iomab-B based on\nabsorbed dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA\ntrial based on several interactions with the FDA prior to the start of the SIERRA trial. Based on this revised approach now required by\nthe FDA, the safety and efficacy data generated from all Iomab-B studies, including the SIERRA trial, are inadequate to seek regulatory\napproval for Iomab-B, as dosing based on maximum tolerable dose of 24 Gy to the liver will lead to variable doses to the bone marrow (the\ntarget organ), result in underdosing or overdosing of patients and translate to a global patient safety risk. We are seeking a strategic\npartner for the U.S. in order to conduct the additional studies required by the FDA; however, we may not be successful in our efforts\nto find such a partner, or the trials and studies may not be successful. Further, there are no assurances that we can satisfy all of the\nFDA’s requests, and there could be additional regulatory hurdles that may result in either non-acceptance or non-approval of a future\nBLA filing. The U.S. commercial opportunity for Iomab-B may thus never be realized.\n\n \n\nAs previously disclosed and\nnoted above, Actinium has licensed to Immedica the exclusive product rights for commercialization of Iomab-B in the EUMENA region. We\nare evaluating the impact of the FDA’s 2024 determination of the SIERRA trial results in the context of global regulatory submissions\nfor Iomab-B. At this time, filings for regulatory approval, obtaining regulatory approvals, and successful commercialization of Iomab-B\nin the EUMENA region and on a global basis are highly uncertain and may never be realized.\n\n \n\n**We are highly dependent on our key personnel,\nand if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our\nbusiness strategy.**\n\n \n\nOur future operations and\nsuccesses depend in large part upon the continued service of key members of our senior management team whom we are highly dependent upon\nto manage our business. If any member of our current senior management terminates his or her employment with us and we are unable to find\na suitable replacement quickly, the departure could have a material adverse effect on our business.\n\n \n\nIn February 2026, Steve O’Loughlin\ntendered his resignation as the Chief Financial Officer of our Company. To fill this executive vacancy, our Board appointed Sandesh Seth,\nthe current Chairman and Chief Executive Officer of the Company, to serve as our principal financial officer. In the second quarter\nof 2025, we conducted a workforce optimization that reduced our headcount by approximately fourteen percent and announced a strategic\npipeline prioritization which led to further departures from the workforce in 2025. We do not expect these departures to have a material\nimpact on our operations or ability to execute our operating plan and are actively seeking a strategic partner for Actimab-A and Iomab-B\nin the U.S. to advance the registrational Phase 2/3 trials required by the FDA.\n\n \n\nAn overall tightening and\nincreasingly competitive labor market has been observed in the U.S. employment market generally. Specific to the biotechnology industry\nin which we operate, there is significant demand and competition for highly specialized talent that we require. A sustained labor shortage\nor increased turnover rates within our employee base as a result of general macroeconomic factors of *force majeure*events, or due\nto dynamics within our industry, could lead to increased costs, such as increased wage rates to attract and retain employees, and could\nnegatively affect our ability to efficiently conduct our clinical development, R&D, business development and potential regulatory\nand commercial activities. If we are unable to hire and retain employees capable of performing at a high-level, or if mitigation measures\nwe may take to respond to a decrease in labor availability, have unintended negative effects, our business could be adversely affected.\nAn overall labor shortage, lack of skilled labor, increased turnover or labor inflation, general macroeconomic factors or as a result\nof biotechnology industry dynamics could have a material adverse impact on our operations, results of operations, liquidity or cash flows.\n\n \n\n43\n\n \n\n \n\nOur future success also depends\non our ability to identify, attract, hire, or engage, retain, and motivate other well-qualified managerial, technical, clinical and regulatory\npersonnel. This activity is likely to create additional demands on the time and attention of our senior management personnel as they identify,\nhire, and train external and internal candidates to fill the sizable number of positions required to execute our business plans, including\nsubmitting a BLA and building a commercial organization. The market for talent in our industry is very competitive. Many of the other\nbiopharmaceutical companies we compete against for qualified personnel have greater financial and other resources, more favorable risk\nprofiles and a longer operating history in the biopharmaceutical industry than we do. They also may provide more diverse opportunities\nand better chances for career advancement. Some of these opportunities may be more appealing to high-quality candidates than what we have\nto offer. There can be no assurance that such professionals will be available in the market, or that we will be able to retain existing\nprofessionals or meet or continue to meet their compensation requirements. Furthermore, the cost base in relation to such compensation,\nwhich may include equity compensation, may increase significantly, which could have a material adverse effect on us. Failure to establish\nand maintain an effective management team and workforce could adversely affect our ability to operate, grow and manage our business.\n\n \n\n**Disruptions at the FDA and other government\nagencies caused by government shutdowns, leadership changes, changes to regulatory approach, layoffs, funding shortages or global health\nconcerns could negatively impact our business**\n\n \n\nThe\nability of the FDA to review proposed clinical trials or approve new products can be affected by a variety of factors, including government\nbudget and funding levels, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept\nthe payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. In addition,\ngovernment funding of other government agencies that fund research and development activities is subject to the political process, including\nexecutive and congressional priorities, the impacts of which are inherently fluid and unpredictable. Disruptions at the FDA and other\nagencies may slow the time necessary for new product candidates to be reviewed and/or approved, which would adversely affect our business.\nIn the recent past, the U.S. government shutdown on October 1, 2025 to November 12, 2025, which curtailed operations at key agencies such\nas the FDA and NIH. Based on this shutdown, we expect trials under our CRADA with the NCI to be delayed. There can be no assurances that\nadditional shutdowns will occur in the future or how long such shutdowns may last. For example, over the last several years, including\nfor 35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the\nFDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current administration has enacted and\ncontinues to propose substantial reductions in force at various government agencies including the FDA, which could significantly reduce\nthe FDA’s capacity to perform its functions in a manner consistent with its past practices and could delay reviews and negatively\nimpact our business. There has been significant turnover and changes in senior leadership at the FDA and other government agencies including\nthe Center for Biologics Evaluation and Research (“CBER”), which is the division of the FDA that would oversee and review\nbiologics-based targeted radiotherapies like those we currently develop and plan to continue to develop. We believe these changes could\nresult in changes in the FDA’s perception of the approvability of therapies, the perceived value of certain therapies or therapeutic\nmodalities, which could create material challenges for our development efforts. As of the date of this Report, there is significant uncertainty\nand risks associated with future FDA regulatory policies and actions that could have a material negative impact on our business. Any or\nall of these factors could cause us to amend, suspend or terminate the development of certain of our preclinical or clinical programs,\nwhich could have material adverse impacts on our business, our product candidates or our ability to continue operations.\n\n** **\n\n**We may be unable to establish sales, marketing\nand commercial supply capabilities.**\n\n \n\nWe do not currently have,\nnor have we ever had, commercial sales and marketing capabilities. If any of our product candidates ultimately become approved and we\ndo not secure a commercial partner, we would have to build and establish these capabilities in order to commercialize our approved product\ncandidates. The process of establishing commercial capabilities will be expensive and time consuming. Even if we are successful in building\nsales and marketing capabilities, we may not be successful in commercializing any of our product candidates. Any delays in commercialization\nor failure to successfully commercialize any product candidate may have material adverse impacts on our business and ability to continue\noperations.\n\n \n\n44\n\n \n\n \n\n**Our business could be adversely affected\nby the effects of future health epidemics.**\n\n \n\nOur business could be adversely\nimpacted by the effects of future pandemics, epidemics or infectious disease outbreaks. The full impact of such an event cannot be predicted\nat this time, and could depend on numerous factors, including vaccination rates among the population and the response by governmental\nbodies and regulators. Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of a future pandemic\non our business.\n\n \n\nA future pandemic could adversely affect our clinical trial operations,\nincluding our ability to conduct the trials on the expected timelines and recruit and retain patients and principal investigators and\nsite staff who, as healthcare providers, may have heightened exposure to a future pandemic if their geography is impacted by the pandemic.\nFurther, future pandemics could result in delays in our clinical trials due to prioritization of hospital resources toward the pandemic,\nrestrictions on travel, potential unwillingness of patients to enroll in trials, or the inability of patients to comply with clinical\ntrial protocols if quarantines or travel restrictions are implemented that impede patient movement or interrupt healthcare services. In\naddition, we rely on independent clinical investigators, contract research organizations and other third-party service providers to assist\nus in managing, monitoring and otherwise carrying out our preclinical studies and clinical trials, and a future pandemic may affect their\nability to devote sufficient time and resources to our programs or to travel to sites to perform work for us, which may result in delays\nor hinder our ability to collect data from our clinical trials.\n\n \n\nAdditionally, a future pandemic\nmay result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB,\nlocal and foreign regulators, ethics committees and other important agencies and contractors due to limitations in employee resources\nor forced furlough of government employees.\n\n \n\n**Our business is subject to cybersecurity\nrisks.**\n\n \n\nOur operations are increasingly\ndependent on information technologies and services. Threats to information technology systems associated with cybersecurity risks and\ncyber incidents or attacks continue to grow, and include, among other things, storms and natural disasters, terrorist attacks, utility\noutages, theft, viruses, phishing, malware, design defects, human error, and complications encountered as existing systems are maintained,\nrepaired, replaced, or upgraded. Risks associated with these threats include, among other things:\n\n \n\n \n●\ntheft or misappropriation of funds;\n\n \n\n \n●\nloss, corruption, or misappropriation of intellectual property, or other proprietary, confidential or personally identifiable information (including supplier, clinical data or employee data);\n\n \n\n \n●\ndisruption or impairment of our and our business operations and safety procedures;\n\n \n\n \n●\ndamage to our reputation with our potential partners, patients and the market;\n\n \n\n \n●\nexposure to litigation; and\n\n \n\n \n●\nincreased costs to prevent, respond to or mitigate cybersecurity events.\n\n \n\nAlthough we utilize various procedures and controls to mitigate our\nexposure to such risk, cybersecurity attacks and other cyber events are evolving and unpredictable. Moreover, we have no control over\nthe information technology systems of third parties conducting our clinical trials, our suppliers, and others with which our systems may\nconnect and communicate. As a result, the occurrence of a cyber incident could go unnoticed for a period of time.\n\n \n\nWe have cybersecurity insurance\ncoverage in the event we become subject to various cybersecurity attacks, however, we cannot ensure that it will be sufficient to cover\nany particular losses we may experience as a result of such cyberattacks. Any cyber incident could have a material adverse effect on our\nbusiness, financial condition and results of operations.\n\n \n\n45\n\n \n\n \n\n**Risks Related to Regulation**\n\n** **\n\n**The FDA, EMA or comparable foreign regulatory\nauthorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates.**\n\n \n\nOur products are subject to\nrigorous regulation by the FDA, EMA and numerous other federal, state and foreign governmental authorities. The process of seeking regulatory\napproval to market an antibody radiation-conjugate product is expensive and time-consuming, and, notwithstanding the effort and expense\nincurred, approval is never guaranteed. If we are not successful in obtaining timely approval of our products from the regulators, we\nmay never be able to generate significant revenue and may be forced to cease operations. In particular, the FDA permits commercial distribution\nof a new antibody radiation-conjugate product only after a BLA for the product has received FDA approval. The BLA process is costly, lengthy\nand inherently uncertain. Any BLA filed by us will have to be supported by extensive data, including, but not limited to, technical, preclinical,\nclinical trial, chemistry, manufacturing and controls and labeling data, to demonstrate to the FDA’s satisfaction the safety and\nefficacy of the product for its intended use. The lengthy approval process as well as the unpredictability of future clinical trial results\nmay result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm our business,\nresults of operations and prospects. In addition, even if we were to obtain approval, regulatory authorities may approve any of our product\ncandidates for fewer or more limited indications than we request, may not obtain the price we intend to charge for our products, may grant\napproval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that\ndoes not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the\nforegoing scenarios could materially harm the commercial prospects for our product candidates.\n\n \n\nFor instance, as for Iomab-B,\ndespite the Phase SIERRA 3 trial meeting the primary endpoint of durable Complete Remission (dCR) with statistical significance (p-value<0.0001),\nthe FDA has determined that demonstrating an OS benefit in a randomized head-to-head trial is required for a BLA filing. In addition,\nthe FDA is also requiring that an additional dose optimization trial demonstrating safety and efficacy be completed to calculate the dose\nof Iomab-B based on absorbed dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was\ndone in the SIERRA trial based on several interactions we had with the FDA before starting the SIERRA trial. The head-to-head Phase 3\ntrial will evaluate allogeneic bone marrow transplant (BMT) using Iomab-B plus a reduced intensity conditioning regimen of fludarabine\nand total body irradiation (Flu/TBI) versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI.\nThis is different from the SIERRA trial, which allowed physician’s choice of salvage therapies and heterogenous conditioning regimens\nin the control arm. However, there are no assurances that the additional trials will be completed or successful or that we can satisfy\nall of the FDA’s requests. There could also be additional regulatory hurdles that may result in either non-acceptance or non-approval\nof a future BLA filing.\n\n \n\nAs previously disclosed and\nnoted above, Actinium has licensed to Immedica the exclusive product rights for commercialization of Iomab-B in the Europe, Middle East,\nand North Africa (EUMENA) region. We are evaluating the impact of the FDA’s 2024 determination of the SIERRA trial results referred\nto above in the context of global regulatory submission for Iomab-B. At this time, filings for regulatory approval, obtaining regulatory\napprovals, and successful commercialization of Iomab-B in the EUMENA region and on a global basis are highly uncertain and may never be\nrealized.\n\n \n\nWe are also evaluating Iomab-ACT,\nwhich uses a lower dose I-131 for conditioning prior to cellular therapies such as CAR-T and gene therapies. We are currently studying\nIomab-ACT in three clinical trials including two investigator sponsored studies.\n\n \n\nOur Actimab-A (lintuzumab-Ac-225) product candidate has also been studied\nin several Phase 1 and 2 trials under our sponsorship and investigator-initiated trials in patients with r/r AML and we plan to continue\nto study Actimab-A in clinical trials. Actimab-A is also being developed under a cooperative research and development agreement (CRADA)\nwith the National Cancer Institute (NCI) and we expect clinical trials to be initiated that will study Actimab-A as a single agent or\nin combination with other therapies. Product candidates utilizing the lintuzumab antibody would require BLA approval before they can be\nmarketed in the United States. We are in the early stages of evaluating other product candidates consisting of conjugates of Ac-225 with\nhuman or humanized antibodies for preclinical and clinical development in other types of cancer such as ATNM-400. The FDA may not approve\nthese products for the indications that are necessary or desirable for successful commercialization. The FDA may fail to approve any IND,\nBLA or NDA we submit for new product candidates or for new intended uses or indications for approved products or future product candidates.\nFailure to obtain FDA approval for our products in the proposed indications would have a material adverse effect on our business prospects,\nfinancial condition and results of operations.\n\n \n\n46\n\n \n\n \n\nThe approval process in the\nUnited States and in other countries could result in unexpected and significant costs for us and consume management’s time and other\nresources. The FDA, EMA and other foreign regulatory agencies could ask us to supplement our submissions, collect non-clinical data, conduct\nadditional clinical trials or engage in other time-consuming actions, or it could simply deny our applications. In addition, even if we\nobtain approval to market our products in the United States or in other countries, the approval could be revoked, or other restrictions\nimposed if post-market data demonstrates safety issues or lack of effectiveness. We cannot predict with certainty how, or when, the FDA,\nEMA or other regulatory authorities will act. If we are unable to obtain the necessary regulatory approvals, our financial condition and\ncash flow may be materially adversely affected, and our ability to grow domestically and internationally may be limited. Additionally,\neven if we obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications that\nwe request. The Company’s products may not be approved for the specific indications that are most necessary or desirable for successful\ncommercialization or profitability.\n\n \n\nDisruptions\nat the FDA and other agencies may slow the time necessary for new product candidates to be reviewed and/or approved, which would adversely\naffect our business and may cause us to amend our business strategy. From October 1, 2025 until November 12, 2025, the U.S federal government\nwas shut down, which curtailed operations of key agencies such as the FDA and the NIH. Our ability to advance clinical development, obtain\nregulatory interactions/approvals, or secure government-funded grants may be delayed or disrupted by the aforementioned federal government\nshutdown. For example, the NCI with whom we have a CRADA for the development of Actimab-A was not operating during the shutdown. As a\nresult, trials active and planned under our CRADA are expected to be delayed. For example, over the last several years, including for\n35 days beginning on December 22, 2018, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA,\nhave had to furlough critical FDA employees and stop critical activities. In addition, the current administration has enacted and continues\nto propose substantial reductions in force at various government agencies including the FDA, which could significantly reduce the FDA’s\ncapacity to perform its functions in a manner consistent with its past practices and could delay reviews and negatively impact our business.\nThere has been significant turnover and changes in senior leadership at the FDA and other government agencies including the Center for\nBiologics Evaluation and Research (“CBER”), which is the division of the FDA that would oversee and review biologics based\ntargeted radiotherapies like those we currently develop and plan to continue to develop. We believe these changes could result in changes\nin the FDA’s perception of the approvability of therapies, the perceived value of certain therapies or therapeutic modalities, which\ncould create material challenges for our development efforts. At this time, there is significant uncertainty and risks associated with\nfuture FDA regulatory policies and actions that could have a material negative impact on our business. Any or all of these factors could\ncause us to amend, suspend or terminate the development of certain of our preclinical or clinical programs, which could have material\nadverse impacts on our business, our product candidates or our ability to continue operations.\n\n \n\n**We have not demonstrated that any of our\nproducts are safe or effective for any indication and will continue to expend substantial time and resources on clinical development before\nany of our current or future product candidates will be eligible for FDA approval, if ever.**\n\n \n\nWe expect that a substantial\nportion of our efforts and expenditures over the next few years will be devoted to development of our existing and contemplated biological\nproduct candidates. Accordingly, our business currently depends heavily on the successful development, FDA approval, and commercialization\nof such candidates, which may never receive FDA approval or be successfully commercialized even if FDA approval is received. The research,\ntesting, manufacturing, labeling, approval, sale, marketing, and distribution of our biological product candidates are, and will remain,\nsubject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, as applicable. We\nare currently not permitted to market any of our current or future product candidates in the United States until we receive FDA approval\n(of each) via the BLA process. To date, we have three product candidates in clinical development and have not-yet submitted a BLA for\nany of our candidates and, for many such candidates, do not expect to be in a position to do so for the foreseeable future, as there are\nnumerous developmental steps that must be completed before we can prepare and submit a BLA. \n\n \n\n47\n\n \n\n \n\nIn the United States, the\nFDA regulates pharmaceutical and biological product candidates under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and\nthe Public Health Service Act (“PHSA”), as well as their respective implementing regulations. Such products and product candidates\nare also subject to other federal, state, and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent\ncompliance with appropriate federal, state, local, and foreign statutes and regulations requires the expenditure of substantial time and\nfinancial resources. The process required by the FDA before a drug or biological product may be marketed in the United States generally\ninvolves the following:\n\n \n\n \n●\ncompletion of preclinical laboratory tests and animal studies in accordance with FDA’s good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals or other applicable regulations;\n\n \n\n \n●\nsubmission to the FDA of an Investigational New Drug (“IND”) application, which must become effective before human clinical trials in the United States may begin;\n\n  \n\n \n●\nperformance of adequate and well-controlled human clinical trials in accordance with FDA’s IND regulations, good clinical practices (“GCPs”), and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;\n\n \n \n \n\n \n●\nsubmission to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the BLA based on results of preclinical testing and clinical trials;\n\n \n\n \n●\nsatisfactory completion of an FDA inspection of the manufacturing facility or facilities where the biological product is produced, to assess compliance with current good manufacturing practices (“cGMPs”) and assure that the facilities, methods and controls are adequate to preserve the biological product’s identity, strength, quality and purity;\n\n \n\n \n●\npotential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; and\n\n \n \n \n\n \n●\nFDA review and approval, or denial, of the BLA.\n\n \n\nBefore testing any biological\nproduct candidate in humans, the product candidate enters the preclinical testing stage. Preclinical tests include laboratory evaluations\nof product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate.\nThe conduct of the preclinical tests must comply with federal regulations and requirements including GLPs. The clinical trial sponsor\nmust submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data\nor literature and a proposed clinical protocol, to the FDA as part of the IND application. Some preclinical testing may continue even\nafter the IND application is submitted. The IND application automatically becomes effective 30 days after receipt by the FDA, unless the\nFDA raises concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time\nperiod. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. The FDA\nmay also impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or\nnon-compliance. If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized\nby the FDA. Accordingly, we cannot be sure that submission of an IND application will result in the FDA allowing clinical trials to begin\nor that, for those that have already commenced under an active IND application, that issues will not arise that suspend or terminate such\ntrials. \n\n \n\n48\n\n \n\n \n\nClinical trials involve the\nadministration of the biological product candidate to healthy volunteers or patients under the supervision of qualified investigators,\ngenerally physicians not employed by or under the trial sponsor’s control. Clinical trials are conducted under protocols detailing,\namong other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters\nto be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events\nshould occur. Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND application. Clinical trials\nmust be conducted and monitored in accordance with the FDA’s regulations composing the GCP requirements, including the requirement\nthat all research subjects provide informed consent. Further, each clinical trial must be reviewed and approved by an IRB, at or servicing\neach institution at which the clinical trial will be conducted. An IRB is charged with protecting the welfare and rights of trial participants\nand considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in\nrelation to anticipated benefits. The IRB also approves the form and content of the informed consent that must be signed by each clinical\ntrial subject or his or her legal representative and must monitor the clinical trial until completed. Human clinical trials are typically\nconducted in three sequential phases that may overlap or be combined:\n\n \n\n \n●\nPhase 1. The biological product is initially introduced into healthy human subjects and tested for safety. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in subjects.\n\n \n\n \n●\nPhase 2. The biological product is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule.\n\n \n \n \n\n \n●\nPhase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk to benefit ratio of the product and provide an adequate basis for product labeling.\n\n \n\nPost-approval clinical trials,\nsometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to\ngain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.\n\n \n\nAfter the completion of clinical\ntrials of a biological product, FDA approval of a BLA must be obtained before commercial marketing of the biological product. The BLA\nmust include results of product development, laboratory and animal studies, human trials, information on the manufacture and composition\nof the product, proposed labeling and other relevant information. The FDA may grant deferrals for submission of data, or full or partial\nwaivers. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept\nthe BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all. Before approving a BLA, the FDA\nwill inspect the facilities at which the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing\nprocesses and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required\nspecifications. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure that the clinical\ntrials were conducted in compliance with IND trial requirements and GCP requirements. To assure cGMP and GCP compliance, an applicant\nmust incur significant expenditure of time, money and effort in the areas of training, record keeping, production, and quality control.\n\n \n\nNotwithstanding the submission\nof relevant data and information, the FDA may ultimately decide that the BLA does not satisfy its regulatory criteria for approval and\ndeny approval. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret\nthe same data. We cannot predict with any certainty if or when we might submit a BLA for regulatory approval for our product candidates\nor whether any such BLA will be approved by the FDA. Human clinical trials are very expensive and difficult to design and implement, in\npart because they are subject to rigorous regulatory requirements. For example, the FDA may not agree with our proposed endpoints for\nany clinical trial we propose, which may delay the commencement of our clinical trials. The clinical trial process is also lengthy and\nrequires substantial time, effort and expense.\n\n \n\n49\n\n \n\n \n\nWe expect that the clinical trials we need to conduct to be in a position\nto submit BLAs for our product candidates currently in-development will take at least several years to complete. Moreover, failure can\noccur at any stage of the trials, and we could encounter problems that cause us to abandon or repeat clinical trials. Also, the results\nof early preclinical and clinical testing may not be predictive of the results of subsequent clinical trials. A number of companies in\nthe biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety\nprofiles, notwithstanding promising results in earlier studies, and preclinical and clinical data are often susceptible to multiple interpretations\nand analyses. Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical\ntrials have, nonetheless, failed to obtain marketing approval of their products. Success in preclinical testing and early clinical trials\ndoes not ensure that later clinical trials, which involve many more subjects, and the results of later clinical trials may not replicate\nthe results of prior clinical trials and preclinical testing. Any failure or substantial delay in our product development plans may have\na material adverse effect on our business.\n\n \n\n**We may encounter substantial delays in our\nclinical trials or may not be able to conduct our trials on the timelines we expect.**\n\n \n\nWe cannot predict whether\nwe will encounter problems with any of our ongoing or planned clinical trials that will cause us or regulatory authorities to delay, suspend,\nor discontinue clinical trials or to delay the analysis of data from ongoing clinical trials. Any of the following could delay or disrupt\nthe clinical development of our product candidates and potentially cause our product candidates to fail to receive regulatory approval:\n\n \n\n \n●\nconditions imposed on us by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;\n\n \n\n \n●\ndelays in receiving, or the inability to obtain, required approvals from IRBs or other reviewing entities at clinical sites selected for participation in our clinical trials;\n\n \n\n \n●\ndelays in enrolling patients into clinical trials;\n\n \n\n \n●\na lower than anticipated retention rate of patients in clinical trials;\n\n \n\n \n●\nthe need to repeat or discontinue clinical trials as a result of inconclusive or negative results or unforeseen complications in testing or because the results of later trials may not confirm positive results from earlier preclinical studies or clinical trials;\n\n \n \n \n\n \n●\ninadequate supply, delays in distribution, deficient quality of, or inability to purchase or manufacture drug product, comparator drugs or other materials necessary to conduct our clinical trials;\n\n \n\n \n●\nunfavorable FDA or other foreign regulatory inspection and review of a clinical trial site or records of any clinical or preclinical investigation;\n\n \n \n \n\n \n●\nserious and unexpected drug-related side effects experienced by participants in our clinical trials, which may occur even if they were not observed in earlier trials or only observed in a limited number of participants;\n\n \n \n \n\n \n●\na finding that the trial participants are being exposed to unacceptable health risks;\n\n \n \n \n\n \n●\nFunding cuts to the NCI, which could delay and/or pause or cause the termination of our ongoing and planned clinical trials under our CRADA;\n\n \n \n \n\n \n●\nthe placement by the FDA or a foreign regulatory authority of a clinical hold on a trial; or\n\n \n \n \n\n \n●\ndelays in obtaining regulatory agency authorization for the conduct of our clinical trials.\n\n \n\nWe may suspend, or the FDA\nor other applicable regulatory authorities may require us to suspend, clinical trials of a product candidate at any time if we or they\nbelieve the patients participating in such clinical trials, or in independent third-party clinical trials for drugs based on similar technologies,\nare being exposed to unacceptable health risks including but not limited to unacceptable or suboptimal factors related to toxicity, clinical\nefficacy, imbalances in safety and efficacy profiles or for other reasons.\n\n \n\n50\n\n \n\n \n\nFurther, individuals involved\nwith our clinical trials may serve as consultants to us from time to time and receive stock options or cash compensation in connection\nwith such services. If these relationships and any related compensation to the clinical investigator carrying out the study result in\nperceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected interpretation of the\nstudy, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial\nitself may be jeopardized. The delay, suspension or discontinuation of any of our clinical trials, or a delay in the analysis of clinical\ndata for our product candidates, for any of the foregoing reasons, could adversely affect our efforts to obtain regulatory approval for\nand to commercialize our product candidates, increase our operating expenses and have a material adverse effect on our financial results. \n\n \n\nClinical trials may also be\ndelayed or terminated as a result of ambiguous or negative interim results. In addition, a clinical trial may be suspended or terminated\nby us, the FDA, the IRBs at the sites where the IRBs are overseeing a trial, or a data safety monitoring board, or DSMB (Data Safety Monitoring\nBoard)/DMC (Data Monitoring Committee), overseeing the clinical trial at issue, or other regulatory authorities due to a number of factors,\nincluding:\n\n \n\n \n●\nfailure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;\n\n \n\n \n●\ninspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;\n\n \n\n \n●\nvarying interpretation of data by the FDA or similar foreign regulatory authorities;\n\n \n\n \n●\nfailure to achieve primary or secondary endpoints or other failure to demonstrate efficacy;\n\n \n\n \n●\nunforeseen safety issues; or\n\n \n\n \n●\nlack of adequate funding to continue the clinical trial.\n\n \n\n**Modifications to our product candidates\nmay require federal approvals.**\n\n \n\nThe BLA application is the\nvehicle through which the company may formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United\nStates. Once a particular product candidate receives FDA approval, expanded uses or uses in new indications of our products may require\nadditional human clinical trials and new regulatory approvals, including additional IND and BLA submissions and premarket approvals before\nwe can begin clinical development, and/or prior to marketing and sales. If the FDA requires new approvals for a particular use or indication,\nwe may be required to conduct additional clinical studies, which would require additional expenditures and harm our operating results.\nIf the products are already being used for these new indications, we may also be subject to significant enforcement actions.\n\n \n\nConducting clinical trials\nand obtaining approvals is a time-consuming process, and delays in obtaining required future approvals could adversely affect our ability\nto introduce new or enhanced products in a timely manner, which in turn would have an adverse effect on our business prospects, financial\ncondition and results of operation.\n\n \n\n**Clinical trials necessary to support approval\nof our product candidates are time-consuming and expensive.**\n\n \n\nInitiating and completing\nclinical trials necessary to support FDA approval of a BLA for ATNM-400, Actimab-A, Iomab-ACT, Iomab-B, and other product candidates,\nis a time-consuming and expensive process, and the outcome is inherently uncertain. Moreover, the results of early clinical trials are\nnot necessarily predictive of future results, and any product candidate we advance into clinical trials may not have favorable results\nin later clinical trials.\n\n \n\n51\n\n \n\n \n\nFor instance, we worked with\nthe FDA to develop the SIERRA clinical trial to test the safety and efficacy of Iomab-B in patients with r/r AML who are aged 55 and above\nprior to a BMT. Even though the SIERRA trial met the primary endpoint of dCR with statistical significance (p-value<0.0001), the FDA\nhas determined that the analyses from the SIERRA trial do not support a BLA filing for Iomab-B. The FDA now requires an additional head-to-head\nPhase 3 clinical study. We have further discussed the specifics of this additional clinical trial with the FDA. Based on these discussions,\nActinium believes it has aligned with the FDA on the patient population for this additional clinical trial, which can include all adult\npatients aged 18 and above with active AML with blasts counts greater than 5% and less than 20%. This is a broader patient population\nthan the patients enrolled on the SIERRA trial, which only enrolled patients aged 55 and above. Further, the FDA is also requiring that\nan additional dose optimization trial demonstrating safety and efficacy be completed to calculate the dose of Iomab-B based on absorbed\ndose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA trial based\non several interactions we had with the FDA before starting the SIERRA trial. We are seeking a strategic partner for Iomab-B in the U.S.\nto advance these additional trials. Even if we are able to secure a partner, there are no assurances that the additional trials will be\nsuccessful or that we can satisfy all of the FDA’s requests. There could also be additional regulatory hurdles that may result in\neither non-acceptance or non-approval of a future BLA.\n\n \n\n**Preliminary, Interim, and “top-line”\ndata from our preclinical studies and clinical trials that we announce or publish from time to time may change as more patient data become\navailable and are subject to audit and verification procedures that could result in material changes in the final data.**\n\n \n\nFrom time to time, we may\npublicly disclose preliminary, interim, and top-line data from our clinical trials, which is based on a preliminary analysis of then-available\ndata, and the results and related findings and conclusions are subject to change as more patient data become available or following a\nmore comprehensive review of the data related to the particular study or trial. We may also make assumptions, estimations, calculations\nand conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all\ndata. Our clinical trials may be open label studies and certain of our clinical development and/or operations staff may review interim\nor preliminary safety or efficacy data during routine data collection, cleaning and analysis from time to time. Interim or preliminary\nresults that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such\nresults once additional data have been received and fully evaluated. Preliminary, interim or top-line data also remain subject to audit\nand verification procedures that may result in the final data being materially different from the top-line, interim or preliminary data\nwe previously published. As a result, top-line, interim and preliminary data should be viewed with caution until the final data are available.\n\n \n\nFrom time to time, we may\nalso disclose interim data from our preclinical studies and clinical trials. Interim data from preclinical studies are not necessarily\npredictive of future success in clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one\nor more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse\ndifferences between interim data and final data could significantly harm our business prospects. Further, disclosure of interim data by\nus or by our competitors could result in volatility in the price of our common stock.\n\n \n\nFurther, others, including\nregulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret\nor weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization\nof the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose\nregarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with\nwhat we determine is material or otherwise appropriate information to include in our disclosure.\n\n \n\nIf the interim, top-line or\npreliminary data that we report differ from final results, or if others, including regulatory authorities, disagree with the conclusions\nreached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating\nresults, prospects or financial condition.\n\n \n\n52\n\n \n\n \n\n**Even if our preclinical studies or early\nclinical trials are favorable, later clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates,\nwhich would prevent or delay regulatory approval and commercialization.**\n\n \n\nEven if our preclinical studies are favorable and our clinical trials\nare completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or foreign\nauthorities will agree with our conclusions regarding them. Success in preclinical studies and early clinical trials does not ensure that\nlater clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and preclinical\nstudies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated\nuses. If the FDA concludes that any current or future clinical trials for ATNM-400, Actimab-A, Iomab-ACT, Iomab-B or any other product\ncandidate for which we might seek approval, have failed to demonstrate safety and effectiveness, we would not receive FDA approval to\nmarket that product candidate in the United States for the indications sought. In addition, such an outcome could cause us to abandon\nthe product candidate and might delay the development of others. Any delay or termination of our clinical trials will delay or preclude\nthe filing of any submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate revenues.\nIt is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of a product\ncandidate’s profile.\n\n \n\n**The intellectual property related to certain\nantibodies we have licensed has expired or likely expired.**\n\n \n\nThe key patents related to\nthe humanized antibody lintuzumab, which we use in our Actimab-A product candidate, have expired. It is generally possible that others\nmay be eventually able to use an antibody with the same sequence, and we will then need to rely on additional patent protection covering\nalpha particle drug products comprising Ac-225. Our final drug construct, Actimab-A, consists of the lintuzumab antibody labeled with\nthe isotope Ac-225. We currently own issued and pending patents relating to methods of manufacturing Actimab-A, methods of treatment using\nActimab-A and production of the Ac-225 isotope. In addition, we possess trade secrets and know how related to the manufacturing and use\nof isotopes. Any competing product based on the lintuzumab antibody is likely to require several years of development before achieving\nour product candidate’s current status and may be subject to significant regulatory hurdles, but such development by others is nevertheless\na possibility that could negatively impact our business in the future. We own 4 issued U.S. patents, 2 issued Canadian patents, 2 issued\nEuropean patents (each validated as a national patent in several countries) and 1 issued Japanese patent that relate to the composition\nof our Iomab-B product candidate. Patent applications relating to Iomab-B are also pending in the U.S. and internationally. We have and\nmay continue to file patents related to Iomab-B that can provide barriers to entry but there is no certainty that these patents will be\ngranted or such granting thereof will adequately prevent others from seeking to replicate and use the apamistamab antibody or the construct.\nOur patent portfolio includes pending applications related to radioimmunoconjugate composition, formulation administration, and methods\nof use in treating solid or liquid cancers. This subject matter includes composition, administration, and methods of treatment for our\nproduct candidates Actimab-A and Iomab-B. Any competing product based on the antibody used in Iomab-B is likely to require several years\nof development before achieving our product candidate’s current status and may be subject to significant regulatory hurdles. Further,\nif approved, Iomab-B would be entitled to 12 years of market exclusivity in the U.S. and 10 years in Europe, during which time no generic\nbiologic or biosimilar product referencing Iomab-B can be granted marketing approval.\n\n \n\n**Our Actimab-A program clinical trials are\ntesting the same drug construct.**\n\n** **\n\nOur Actimab-A program is comprised\nof several clinical trials conducted under the CRADA with NCI, Actinium sponsored trials, investigator-initiated trials in AML and other\nmyeloid indications and solid tumors that will study the same drug construct consisting of lintuzumab-Ac-225. Negative results from any\nof these trials could adversely impact our ability to enroll or complete our other trials studying lintuzumab-Ac-225, including future\nstudies conducted under our CRADA with the NCI. Additionally, negative outcomes including safety concerns, may result in the FDA requiring\namendment to certain clinical trials, placing a clinical hold on certain or all clinical trials or discontinuing other trials utilizing\nlintuzumab-Ac-225.\n\n \n\n**We are currently developing, and in the\nfuture may develop, product candidates in combination with other therapies and that may expose us to additional risks.**\n\n** **\n\nWe are currently developing,\nand may develop future product candidates, for use in combination with one or more currently approved therapies. For example, Actimab-A\nis expected to be tested in combination with KEYTRUDA® and OPDIVO® for treating HNSCC and NSCLC. If any\nof the approved therapies we currently or may, in the future, use in combination with a current or future product candidate is found defective,\nremoved from the market, or otherwise becomes unavailable, our clinical trials may face significant delays, be suspended, or terminated.\nAny such events would likely have a material impact on our operations and the development of the affected product candidate(s) and may\nultimately prevent the approval of such product candidate or render continued development efforts too costly to proceed.\n\n \n\n53\n\n \n\n \n\nEven if a current or future\nproduct candidate were to receive FDA approval to be commercialized in the U.S. for use in combination with one or more existing therapies,\nwe would continue to be subject to the risk that the FDA or similar foreign regulatory authorities could revoke approval of the therapy\nused in combination with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with any such existing\ntherapies. This could result in our own products being removed from the market or cause material delays in, or the suspension or discontinuation,\nof our production and/or distribution of the applicable product, as our ability to market any such product will be limited to the extent\nspecified in the FDA’s approval, if granted.\n\n** **\n\n**We may be unable to obtain a sufficient\nsupply of isotopes to support clinical development or commercial scale. **\n\n \n\nIodine-131 is a key component\nof our Iomab-B drug candidate. We source medical grade I-131 from multiple suppliers, including two leading global manufacturers. Currently,\nwe believe there is sufficient supply of I-131 to support additional trials we may undertake utilizing I-131 and for future commercialization\nof potential I-131 based products. We continually evaluate I-131 manufacturers and suppliers. While we consider I-131 to be commoditized\nand obtainable through several suppliers, there can be no guarantee that we will be able to secure I-131 or obtain I-131 on terms that\nare acceptable to us.\n\n \n\nActinium-225 is a key component\nof our Actimab-A product candidate, technology platform, preclinical R&D programs including ATNM-400 and other drug candidates that\nwe might consider for development with the Ac-225 payload. We have secured multiple suppliers that are expected to provide cGMP Ac-225\nfor our planned clinical trials. There are adequate quantities of Ac-225 available today to meet our current needs via our present supplier,\nthe Department of Energy (“DOE”), who has been our primary supplier of Ac-225 historically. The Ac-225 currently supplied\nfor our clinical trials from the DOE is derived from the natural decay of thorium-229 from so-called ‘thorium-cows’ and is\nable to produce sufficient quantities that are several multiples of the amount of Ac-225 we require to supply our clinical programs through\nto the early commercialization phase. The DOE is also producing Ac-225 from a recently developed alternative route for Ac-225 production\nvia a linear accelerator that is currently being evaluated by us. Initial preclinical and modelling results have indicated that the linear\naccelerator sourced Ac-225 does not impact labelling efficiency and expected distribution. In accordance with representations made by\nthe DOE, the capacity of Ac-225 from this route is expected to be sufficient to supply all of Actinium’s pipeline and commercial\nAc-225 needs and support new program expansion by not just Actinium but also other companies that are developing Ac-225 based products.\nAdditional routes of Ac-225 production are being pursued by the DOE including the generation of new thorium cows and production via a\ncyclotron. The cyclotron production method for Ac-225 production leverages Actinium’s proprietary technology and know-how and presents\nan additional path towards production of high-quality Ac-225 at a scale that would be able to satisfy commercial needs. In addition, we\nare aware of at least ten other government and non-government entities globally including the U.S., Canada, Russia, Belgium, France and\nJapan that have, or expect to have, ability to supply Ac-225 or equipment for its production within the timeframes relevant to the potential\nfirst commercial approval of our Ac-225-based drug candidate.\n\n \n\nOur contract for supply of this isotope from the DOE must be renewed\nyearly, and we renewed our contract to extend through the end of 2026.  While we expect this contract will continue to be renewed\nat the end of its term as it has since 2009,  there can be no assurance that the DOE will renew the contract or change its policies\nthat allow for the sale of isotope to us. There can be no assurance that the DOE or our other suppliers will be able to supply all of\nthe quantities of Ac-225 we request in the future. Failure to acquire sufficient quantities of medical grade Ac-225 would make it impossible\nto effectively complete clinical trials and to commercialize any Ac-225 based drug candidates that we may develop and would materially\nharm our business.\n\n \n\nOur ability to conduct clinical\ntrials to advance our drug candidates is dependent on our ability to obtain the radioisotopes I-131, Ac-225 and other isotopes we may\nchoose to utilize in the future. Currently, we are dependent on third party manufacturers and suppliers for our isotopes. These suppliers\nmay not perform their contracted services or may breach or terminate their agreements with us. Our suppliers are subject to regulations\nand standards that are overseen by regulatory and government agencies and we have no control over our suppliers’ compliance to these\nstandards. Failure to comply with regulations and standards may result in their inability to supply isotopes and could result in delays\nin our clinical trials, which could have a negative impact on our business. We have developed intellectual property, know-how and trade\nsecrets related to the manufacturing process of Ac-225. While we have manufactured medical grade Ac-225 of a purity compared to the cyclotron\nsourced material in the past, this activity was terminated due to operating cost reasons, and we currently do not have experience in manufacturing\nmedical grade Ac-225 and may not obtain the resources necessary to establish our own manufacturing capabilities in the future. Our inability\nto build out and establish our own manufacturing facilities would require us to continue to rely on third party suppliers as we currently\ndo. However, based on our current third-party suppliers and potential future suppliers of Ac-225 we expect to have adequate isotope supply\nto support our current ongoing clinical trials, current and planned preclinical R&D activities and commercialization should our drug\ncandidates receive regulatory approval.\n\n \n\n54\n\n \n\n \n\n**If we encounter difficulties enrolling patients\nin our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.**\n\n \n\nThe timely completion of clinical\ntrials in accordance with their protocols depends on our ability to enroll a sufficient number of patients who remain in the trial until\nits conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:\n\n \n\n \n●\nthe size and nature of the patient population;\n\n \n\n \n●\nthe patient eligibility criteria defined in the protocol;\n\n \n\n \n●\nthe size of the study population required for analysis of the trial’s primary endpoints;\n\n \n\n \n●\nthe proximity of patients to trial sites;\n\n \n\n \n●\nthe design of the trial;\n\n \n\n \n●\nour ability to recruit clinical trial investigators with the appropriate competencies and expertise;\n\n \n\n \n●\ncompeting clinical trials for similar or alternate therapeutic treatments;\n\n \n\n \n●\nclinician’s and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies;\n\n \n\n \n●\nour ability to obtain and maintain patient consents; and\n\n \n\n \n●\nthe risk that patients enrolled in clinical trials will not complete a clinical trial.\n\n \n\nIn addition, refractory patients,\nwhich several of our trials have or are expected to enroll, participating in clinical trials are seriously and often terminally ill and\ntherefore may not complete the clinical trial due to reasons including comorbid conditions or occurrence of adverse medical events related\nor unrelated to the investigational products, or death. Even if we are able to enroll a sufficient number of patients in our clinical\ntrials, delays in patient enrollment will result in increased costs or affect the timing of our planned trials, which could adversely\naffect our ability to advance the development of our product candidates. \n\n \n\n**FDA may take actions that would prolong,\ndelay, suspend, or terminate clinical trials of our product candidates, which may delay or prevent us from commercializing our product\ncandidates on a timely basis.**\n\n \n\nThere can be no assurance that the data generated in our clinical trials\nwill be acceptable to the FDA, or that if future modifications during the trial are necessary, that any such modifications will be acceptable\nto the FDA. Certain modifications to a clinical trial protocol made during the course of the clinical trial have to be submitted to the\nFDA. This could result in the delay or halt of a clinical trial while the modification is evaluated. In addition, depending on the quantity\nand nature of the changes made, the FDA could take the position that some or all of the data generated by the clinical trial is not usable\nbecause the same protocol was not used throughout the trial. This might require the enrollment of additional subjects, which could result\nin the extension of the clinical trial and the FDA delaying approval of a product candidate. If the FDA believes that its prior approval\nis required for a particular modification, it can delay or halt a clinical trial while it evaluates additional information regarding the\nchange.\n\n \n\n55\n\n \n\n \n\nAny delay or termination of\nour current or future clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required\napprovals from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays\nor termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase in\ncosts and delays in the filing of any submissions with the FDA, delay the approval and commercialization of our product candidates or\nresult in the failure of the clinical trial, which could adversely affect our business, operating results and prospects. Lengthy delays\nin obtaining regulatory approval for Iomab-B or completion of our ongoing or planned clinical trials would adversely affect our business\nand prospects and could cause us to cease operations.\n\n \n\n**We have obtained orphan drug designation\nfrom the FDA for two of our current product candidates and intend to pursue such designation for other candidates and indications in the\nfuture, but we may be unable to obtain such designations or to maintain the benefits associated with any orphan drug designations we have\nreceived or may receive in the future.**\n\n \n\nWe have received orphan drug\ndesignation for Actimab-A and Iomab-B for treatment of AML in both the United States and the EU. Under the Orphan Drug Act, the FDA may\ngrant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects\nfewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no\nreasonable expectation that the cost of developing and making available a drug or biologic for this type of disease or condition will\nbe recovered from sales in the United States for that drug or biologic. Similarly, the EMA grants orphan drug designation to promote the\ndevelopment of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating\ncondition affecting not more than five in 10,000 persons in the EU.\n\n \n\nOrphan drug designation neither\nshortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage in the regulatory\nreview or approval process. In the United States, orphan drug designation entitles a party to financial incentives, such as opportunities\nfor grant funding towards clinical trial costs, tax advantages, and application fee waivers. In addition, if a product candidate receives\nthe first FDA approval for the indication for which it has orphan designation, such product is entitled, upon approval, to seven years\nof orphan-drug exclusivity, during which the FDA may not approve any other application to market the same drug for the same indication,\nunless a subsequently approved product is clinically superior to orphan drug or where the manufacturer is unable to assure sufficient\nproduct quantity in the applicable patient population. In the EU, orphan drug designation entitles a party to financial incentives such\nas reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This period may\nbe reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently\nprofitable not to justify maintenance of market exclusivity.\n\n \n\nEven if we obtain (or have\nobtained) orphan drug designation for certain product candidates, we may not be the first to obtain marketing approval for such candidates\nfor the applicable indications due to the uncertainties inherent in the development of novel biologic products, and, an orphan drug candidate\nmay not receive orphan-drug exclusivity upon approval if such candidate is approved for a use that is broader than the indication for\nwhich it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines\nthat the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product\nto meet the needs of patients with the rare disease or condition.\n\n \n\nFinally, even if we successfully\nobtain orphan-drug exclusivity for an orphan drug candidate upon approval, such exclusivity may not effectively protect the product from\ncompetition because (i) different drugs with different active moieties can be approved for the same condition; and (ii) the FDA or EMA\ncan also subsequently approve a subsequent product with the same active moiety and for the same indication as the orphan drug if the later-approved\ndrug if deemed clinically superior to the orphan drug.\n\n \n\n56\n\n \n\n \n\n**Even if we receive regulatory approval of\nour product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review.**\n\n \n\nAny regulatory approvals that\nwe receive for our product candidates will require surveillance to monitor the safety and efficacy of the product candidate. The FDA may\nalso require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician communication\nplans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization\ntools. In addition, if the FDA or a comparable foreign regulatory authority approves our product candidates, the manufacturing processes,\nlabeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our\nproduct candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety\nand other post-marketing information and reports, registration, as well as continued compliance with cGMPs and GCPs for any clinical trials\nthat we conduct post-approval. In addition, the FDA could require us to conduct another study to obtain additional safety or biomarker\ninformation. Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity\nor frequency, or with our third-party suppliers or manufacturing processes, or failure to comply with regulatory requirements, may result\nin, among other things:\n\n \n\n \n●\nrestrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;\n\n \n\n \n●\nfines, warning letters or holds on clinical trials;\n\n \n\n \n●\nrefusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;\n\n \n\n \n●\nproduct seizure or detention, or refusal to permit the import or export of our product candidates; and\n\n \n\n \n●\ninjunctions or the imposition of civil or criminal penalties.\n\n \n\nThe FDA’s and other\nregulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay\nregulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise\nfrom future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes\nin existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we\nmay lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.\n\n \n\n**Coverage and reimbursement may be limited\nor unavailable in certain market segments for our product candidates which could limit our sales of our product candidates, if approved.**\n\n \n\nThe commercial success of\nour product candidates in both domestic and international markets will be substantially dependent on whether third-party coverage and\nreimbursement is available for patients that use our products. However, the availability of insurance coverage and reimbursement for newly\napproved cancer therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products\nare approved by the FDA as safe and efficacious. Patients using existing approved therapies are generally reimbursed all or part of the\nproduct cost by Medicare or other third-party payors. Medicare, Medicaid, health maintenance organizations and other third-party payors\nare increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as\na result, they may not cover or provide adequate payment for these products. Submission of applications for reimbursement approval generally\ndoes not occur prior to the filing of a BLA for that product and may not be granted until many months after BLA approval. In order to\nobtain coverage and reimbursement for these products, we or our commercialization partners may have to agree to a net sales price lower\nthan the net sales price we might charge in other sales channels. The continuing efforts of government and third-party payors to contain\nor reduce the costs of healthcare may limit our revenue. Initial dependence on the commercial success of our products may make our revenues\nparticularly susceptible to any cost containment or reduction efforts.\n\n \n\n57\n\n \n\n \n\n**Healthcare legislative reform measures intended\nto increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the regulation of the U.S.\nhealthcare system could have a material adverse effect on our business, future revenue, if any, and results of operations.**\n\n** **\n\nIn the United States, there\nhave been a number of legislative and regulatory initiatives focused on containing the cost of healthcare. The Affordable Care Act, for\nexample, substantially changed the way healthcare is financed by both governmental and private insurers. The Affordable Care Act contains\na number of provisions that could impact our business and operations, primarily, once we obtain FDA approval to commercialize one of our\nproduct candidates in the United States, if ever. The Affordable Care Act may also affect our operations in ways we cannot currently predict.\nAffordable Care Act provisions that may affect our business include, among others, those governing enrollment in federal healthcare programs,\nreimbursement changes, rules regarding prescription drug benefits under health insurance exchanges, expansion of the 340B program, expansion\nof state Medicaid programs, fees and increased discount and rebate obligations, transparency and reporting requirements, and fraud and\nabuse enforcement. Such changes may impact existing government healthcare programs, industry competition, formulary composition, and may\nresult in the development of new programs, including Medicare payment for performance initiatives, health technology assessments, and\nimprovements to the physician quality reporting system and feedback program.\n\n \n\nThere have been significant\njudicial, administrative, executive, and legislative initiatives to modify, limit, replace, or repeal the Affordable Care Act since its\nenactment. For example, during his first term, President Trump issued several Executive Orders and other directives designed to delay\nthe implementation of certain provisions of the Affordable Care Act or otherwise circumvent some of the requirements for health insurance\nmandated by the Affordable Care Act. Concurrently, Congress considered legislation that would repeal or replace all or part of the Affordable\nCare Act. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of the Affordable\nCare Act have been passed. For example, the Tax Cuts and Jobs Act of 2017 eliminated the Affordable Care Act provision requiring individuals\nto purchase and maintain health coverage, or the “individual mandate,” by reducing the associated penalty to zero, beginning\nin 2019. In December 2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the Affordable\nCare Act is, therefore, invalid. On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded\nthe case back to the lower court to reassess whether and how such holding affects the validity of the rest of the Affordable Care Act.\nThe Fifth Circuit’s decision on the individual mandate was appealed to the U.S. Supreme Court. On June 17, 2021, the Supreme Court\nheld that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing\nto challenge the constitutionality of the Affordable Care Act’s individual mandate and, accordingly, vacated the Fifth Circuit’s\ndecision and instructed the district court to dismiss the case. As a result, the Affordable Care Act remained in effect in its then-current\nform; however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact any such actions\nmay have on our business. This uncertainty has become even greater given the new Trump administration and its proposed agenda.\n\n \n\nIn addition to the Affordable\nCare Act, there have been numerous other Congressional initiatives and proposed and enacted federal and state legislation designed to,\namong other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs,\nand reform government program reimbursement methodologies for drug products. Pharmaceutical product prices have been the focus of increased\nscrutiny by the government, including certain state attorneys general, members of Congress and the United States Department of Justice.\nState or federal healthcare reform measures or other social or political pressure to lower the cost of pharmaceutical products could have\na material adverse impact on our business, results of operations and financial condition.\n\n \n\nThe Biden administration also\nintroduced various measures in 2021 focusing on healthcare and drug pricing, in particular. For example, on January 28, 2021, former President\nBiden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through\nthe Affordable Care Act marketplace, which began on February 15, 2021, and remained open through August 15, 2021. The executive order\nalso instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare,\nincluding among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that\ncreate unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act. On the legislative\nfront, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid\ndrug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source\ndrugs, which began on January 1, 2024. And, in July 2021, the Biden administration released an executive order entitled, “Promoting\nCompetition in the American Economy,” with multiple provisions aimed at prescription drugs. In response, on September 9, 2021, the\nDepartment of Health and Human Services (“HHS”) released a “Comprehensive Plan for Addressing High Drug Prices”\nthat outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as\nwell as potential administrative actions HHS can take to advance these principles.\n\n \n\n58\n\n \n\n \n\nOn August 16, 2022, former\nPresident Biden signed into law the Inflation Reduction Act of 2022 (the “IRA”), which, among other provisions,\nincluded several measures intended to lower the cost of prescription drugs and related healthcare reforms. Specifically, the IRA authorizes\nand directs the HHS to set drug price caps for certain high-cost Medicare Part B and Part D qualified drugs, with the initial list of\ndrugs announced on August 29, 2023, and the first year of maximum price applicability beginning in 2026. The IRA further authorizes the\nHHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part D drugs faster than the rate\nof inflation. The IRA creates significant changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual\nout-of-pocket spending at $2,000 beginning in 2025. Further, on July 4, 2025, President Trump signed the One Big Beautiful Bill Act into\nlaw which, among other things, is expected to reduce funding to federal healthcare programs, imposes additional requirements to be eligible\nfor healthcare, and clarifies exclusions for orphan drugs under IRA’s Drug Price Negotiation Program.\n\n \n\nThe current Trump Administration\nis also pursuing policies intended to, among other things, reduce regulations and expenditures across government (including at the HHS,\nFDA, NIH, CMS, and other related agencies), lower prescription drug prices, and enhance drug price transparency. These actions, such as\nthose directed by executive orders, may propose policy changes that create additional uncertainty for our business. For example, on April\n15, 2025, the Trump Administration released an executive order entitled, “Lower Drug Prices by Once Again Putting Americans First,”\nwhich among other things, included multiple directives to various agencies aimed at lowering prescription drug prices. Further, in May\n2025, the Trump Administration released two executive orders aimed to promote domestic production of critical medicines and to establish\na most-favored-nation (“MFN”) drug pricing policy that would tie U.S. drug prices to the prices paid for drugs in other countries.\nOther recent actions and proposals include, for example, (1) reducing federal agencies workforces; (2) directing program cuts; (3) rescinding\na Biden administration executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare\nmodels to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI\ntask force and developing a strategic plan; (4) directing certain federal agencies to enforce existing law regarding hospital and price\nplan price transparency and by standardizing prices across hospitals and health plans; (5) as part of the Make America Healthy Again (MAHA)\nCommission’s recent Strategy Report, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical\nadvertising; (6) announcing a new payment initiative called the GENErating cost Reductions fOr U.S. Medicaid Model (“GENEROUS Model”)\nwhere drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid programs; (7) directing HHS and other\nagencies to lower prescription drug costs for Medicare through a variety of initiatives, including by improving upon the Medicare Drug\nPrice Negotiation Program and proposing two rules to incorporate MFN pricing into federal reimbursement for drugs including the Global\nBenchmark for Efficient Drug Pricing Model (“GLOBE Model”) for Medicare Part B and Guarding U.S. Medicare Against Rising Drug\nCosts (“GUARD Model”) for Medicare Part D; (8) launching the TrumpRx direct-to-consumer platform designed to have drug manufacturers\noffer consumers prescription drug MFN pricing equal to or lower than those paid in other developed nations; and (9) calling on Congress\nto enact the “The Great Healthcare Plan” to, among other things, codify and expand MFN pricing, lower government subsidies\nto private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase,\nand enact restrictions on pharmacy benefit managers. These actions and policies may significantly reduce drug prices, potentially impacting\nmanufacturers’ drug pricing strategies and profitability, while increasing operational costs and compliance risks.\n\n \n\nAt the state level, legislatures\nhave increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including\nprice or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency\nmeasures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.\n\n \n\nCurrent and future legislative\nand regulatory changes aimed to further reform healthcare or reduce healthcare costs may limit coverage of or lower reimbursement for\nhealthcare products and treatments. Any reduction in coverage or reimbursement from Medicare, Medicaid, or other government programs may\nresult in similar actions taken by private payors such as reductions in payments. The implementation of cost containment measures or other\nhealthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates.\n\n \n\n59\n\n \n\n \n\n**Changes in the\nhealthcare industry and in healthcare spending could adversely affect our grant funded clinical programs, business, financial condition\nand results of operations.**\n\n \n\nOur business and research\nefforts rely, in part, on funding and support from U.S. government agencies such as the NIH, NCI and HHS. Government funding for these\nprograms is subject to annual budgetary decisions, which can be unpredictable and influenced by shifting political and economic priorities.\nReductions in government support for cancer research or other healthcare initiatives could limit grants, contracts, or other financial\nresources that we or our research collaborators depend on, potentially delaying our clinical programs and increasing our reliance on alternative\nfunding sources. From October 1, 2025 until November 12, 2025, the U.S. federal government was shutdown, which curtailed operations of\nkey agencies such as the FDA and the NIH. The NCI, with whom we have a CRADA for the development of Actimab-A, was not operating\nduring the shutdown. As a result, our ability to advance clinical development, obtain regulatory interactions/approvals, or secure government-funded\ngrants may be delayed or disrupted by the federal government shutdown. For example, active and planned trials under our CRADA are expected\nto be delayed.\n\n \n\nAdditionally, in December 2025, the National Defense Authorization\nAct for Fiscal Year 2026 (“NDAA”) was enacted, which included legislation commonly referred to as the “BIOSECURE Act.”\nThe BIOSECURE Act restricts government agencies from procuring certain biotechnology equipment or services from, or entering into contracts\nwith, entities that use biotechnology equipment or services from designated “biotechnology companies of concern,” (“BCCs”)\nand from expending certain federal loan or grant funds for such equipment or services. BCCs include those that are identified on the Department\nof Defense’s annual List of Chinese Military Companies, also known as the 1260H List, and the government also has the ability to\ndesignate entities as BCCs through a separate designation process. While the BIOSECURE Act has not yet been fully implemented through\nfinal regulations, there remains a continued policy interest in limiting U.S. companies’ relationships with biotechnology providers\nwith relationships with foreign adversaries.\n\n \n\nIf any of our current or future\nvendors, or their affiliates, are designated as a BCC or placed on other U.S. restricted party lists, such designation could impact and\npotentially restrict our ability to purchase equipment or services from such vendors and could adversely affect our existing government-funded\ngrants and our ability to secure future grants. These disruptions could also have adverse effects on the development of our product candidates\nand our business operations. \n\n \n\nMoreover, with the change in presidential administration that recently\noccurred in the United States, government spending programs have become even more difficult to predict and may be subject to greater risk.\nConsiderable uncertainty exists regarding how future budget and program decisions will unfold, including the spending priorities of the\nnew U.S. presidential administration and Congress and what challenges budget reductions may present for our industry generally or for\nour company. For example, President Trump recently attempted to place a widespread freeze on most federal grants and loans. Any freeze,\nreduction, rescission, change in eligibility or compliance requirements, or other actions affecting government support for our products,\nprograms, or studies could significantly impair our research and development activities, business, and operations.\n\n \n\n60\n\n \n\n \n\n**Disruptions at\nthe FDA, the SEC and other government agencies or comparable regulatory authorities caused by government shutdowns, funding shortages\nor global health concerns, in addition to substantial uncertainty regarding the new Administration’s initiatives and how these\nmight impact the FDA, its implementation of laws, regulations, policies and guidance, and its personnel, could hinder government agencies’\nability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or\ncommercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which our business\noperations rely, including timely reviews, which could negatively impact our business.**\n\n \n\nThe ability of the FDA or\ncomparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government\nshutdowns, which recently occurred from October 1, 2025 until November 12, 2025, budget and funding levels, ability to hire and retain\nkey personnel and accept the payment of user fees, and statutory, regulatory, and policy changes that may otherwise affect the FDA’s\nor comparable foreign regulatory authorities’ ability to perform routine functions. In addition, government funding of the SEC and\nother government agencies or comparable foreign regulatory authorities on which our operations may rely, including those that fund research\nand development activities, is subject to the political process, which is inherently fluid and unpredictable. Future government shutdowns\ncould impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue to fund\nour operations.\n\n \n\nDisruptions at the FDA and\nother agencies, including substantial leadership, personnel, and policy changes, may also slow the time necessary for new drugs to be\nreviewed and/or approved by necessary government agencies, which would harm our business. Changes in FDA staffing could result in delays\nin the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance, or implement\nor enforce regulatory requirements in a timely fashion or at all. Similar consequences would also result in the event of another significant\nshutdown of the federal government. For example, over the last several years, the U.S. government has shut down several times and certain\nregulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. If a prolonged government\nshutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities from conducting their regular\ninspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process\nour regulatory submissions, which could materially adversely affect our business, financial condition, results of operations and prospects.\nSuch changes could significantly impact the ability of the FDA to timely review and take action on our regulatory submissions, which could\nhave a material adverse effect on our business. Further, in our operations as a public company, future government shutdowns or substantial\nleadership, personnel, and policy changes could impact our ability to access the public markets and obtain necessary capital in order\nto properly capitalize and continue our operations. If the FDA is constrained in its ability to engage in oversight and implementation\nactivities in the normal course, our business may be negatively impacted.\n\n \n\nWith the change in the U.S.\nPresidential Administration in 2025, there is substantial uncertainty as to whether and how the new administration will seek to modify\nor revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. This uncertainty\ncould present new challenges and/or opportunities as we navigate development of our product candidates. Some of these efforts have manifested\nto date in the form of personnel measures that could impact the FDA’s ability to hire and/or retain key personnel, which could result\nin delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite\nregulatory approvals in the future. Moreover, the new Administration has proposed action to freeze or reduce the budget of the NIH, as\nrelated to its funding for medical research, which could decrease the ability of facilities that rely on NIH funding to enroll and conduct\nclinical trials or increase the costs to us of conducting clinical trials. There remains general uncertainty regarding future activities.\nThe new Administration could issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or\ncreate a more challenging or costly environment to pursue the development of new therapeutic products. Alternatively, state governments\nmay attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse\nto our operations. If we become negatively impacted by future governmental orders, regulations, policies or guidance as a result of the\nnew Administration, there could be a material adverse effect on us and our business.\n\n \n\n61\n\n \n\n \n\n**Our relationships with customers, health-care\nprofessionals and third-party payors may be subject to applicable healthcare laws, which could expose us to penalties, including administrative,\ncivil or criminal penalties, damages, fines, imprisonment, exclusion from participation in federal healthcare programs such as Medicare\nand Medicaid, reputational harm, the curtailment or restructuring of our operations and diminished future profits and earnings.**\n\n \n\nHealthcare professionals and\nthird-party payors will play a primary role in the recommendation and prescription of any product candidates for which we obtain marketing\napproval. Our current and future arrangements with customers, healthcare professionals and third-party payors may expose us to broadly\napplicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships\nthrough which we conduct research, market, sell and distribute any products for which we obtain marketing approval. Federal and state\nhealthcare laws and regulations that may affect our operations, directly or indirectly, include the following, among others:\n\n \n\n \n●\nthe federal Anti-Kickback Statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;\n\n \n\n \n●\nthe federal false claims laws, including civil whistleblower or qui tam actions under the FCA, which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;\n\n \n\n \n●\nHIPAA, as amended by HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;\n\n \n\n \n●\nthe federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;\n\n \n\n \n●\nthe federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of value provided to physicians and any ownership and investment interests held by physicians or their immediate family members. Beginning in 2022, applicable manufacturers became required to report such information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year; and\n\n \n\n \n●\nanalogous state laws and regulations, including (among others) state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the United States federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information and that require tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; state and local laws that require the registration of pharmaceutical sales representatives; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating compliance efforts.\n\n \n\n62\n\n \n\n \n\nEfforts to comply with applicable\nhealthcare laws and regulations will involve substantial costs. Interpretations of standards of compliance under these laws and regulations\nare rapidly changing and subject to varying interpretations and it is possible that governmental authorities will conclude that our business\npractices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare\nlaws and regulations. If our operations are found to be in violation of any of these laws or any other laws that may apply to us, we may\nbe subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs,\nsuch as Medicare and Medicaid, reputational harm, imprisonment, additional reporting obligations and oversight (if we become subject to\na corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws), and the curtailment or restructuring\nof our operations, any of which could diminish our future profits or earnings. If any of the physicians or other providers or entities\nwith whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative\nsanctions, including exclusions from government funded healthcare programs. \n\n \n\n**Third-party payors may not adequately reimburse\ncustomers for any product candidates that we may commercialize or promote and may impose coverage restrictions or limitations such as\nprior authorizations and step edits that affect their use.**\n\n \n\nOur ability to commercialize\nany product candidates successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products\nand related treatments will be available from government health programs, private health insurers, integrated delivery networks and other\nthird-party payors. Third-party payors decide which medications they will pay for and establish reimbursement levels. A significant trend\nin the United States healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted\nto control costs by limiting coverage and the amount of payment for particular medications. Increasingly, third-party payors are requiring\nthat drug companies provide predetermined discounts from list prices and are challenging the prices charged for medical products. Coverage\nand reimbursement may not be available for any product that we commercialize and, if reimbursement is available, the level of reimbursement\nmay not be sufficient for commercial success. Coverage and reimbursement may impact the demand for, or the price of, any product candidate\nfor which we obtain marketing approval. If coverage and reimbursement are not available or is available only to limited levels, we may\nnot be able to successfully commercialize any product candidate for which we obtain marketing approval.\n\n \n\nObtaining reimbursement approval\nfor any product candidate for which we obtain marketing approval from any government or other third-party payor is a time-consuming and\ncostly process. There may be significant delays in obtaining coverage and adequate reimbursement for newly approved products. Moreover,\neligibility for coverage and reimbursement does not imply that any product will be paid for in all cases or at a rate that covers our\ncosts, including research, development, manufacture, sale and distribution. Even when a payor determines that a product that we may commercialize\nor promote is eligible for reimbursement under its criteria, the payor may impose coverage limitations that preclude payment for some\nuses that are approved by the FDA, or may impose restrictions, such as prior authorization requirements, or may simply deny coverage altogether.\nInterim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent.\nCoverage and reimbursement rates may vary according to the use of the drug and the medical circumstances under which it is used may be\nbased on reimbursement levels already set for lower cost products or procedures or may be incorporated into existing payments for other\nservices. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private\npayors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices\nthan in the United States. Furthermore, the Centers for Medicare and Medicaid Services frequently change product descriptors, coverage\npolicies, product and service codes, payment methodologies and reimbursement values. Commercial third-party payors often rely upon Medicare\ncoverage policies and payment limitations in setting their own reimbursement policies. Our inability to promptly obtain and maintain coverage\nand profitable payment rates from both government-funded programs and private payors for any approved products that we develop could have\na material adverse effect on our operating results, our ability to raise capital needed to commercialize our approved products and our\noverall financial condition.\n\n \n\nIn the U.S. and some jurisdictions\noutside the U.S., there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system\nthat could impact our business. Generally, there has been increasing legislative and enforcement interest in the U.S. with respect to\ndrug pricing, including specialty drug pricing practices, in light of the rising cost of prescription drugs and biologics. Specifically,\nthere have been U.S. Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency\nto drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the price of drugs under Medicare,\nand reform government program reimbursement methodologies for drugs and biologics. In addition, the concept of most-favored nation pricing\nhas been raised that would seek to establish drug prices in the U.S. to the lowest level paid by comparable countries. Such policy action\ncould cause us to amend, suspend or terminate the development of any or all of our product candidates if a viable commercial market did\nnot exist, which could have a material adverse impact on our business and ability to operate.\n\n \n\n63\n\n \n\n \n\nIf future legislation were\nto impose direct governmental price controls and access restrictions, it could have a significant adverse impact on our business and financial\nresults. Managed care organizations, as well as Medicaid and other government authorities, continue to seek price discounts. At the state\nlevel, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biologic product\npricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure\nand transparency measures, and, in some cases, to encourage importation from other countries and bulk purchasing. Due to the volatility\nin the current economic and market dynamics, we are unable to predict the impact of any unforeseen or unknown legislative, regulatory,\npayor or policy actions, which may include cost containment and healthcare reform measures. Such policy actions could have a material\nadverse impact on our business and ability to operate.\n\n** **\n\n**Risks Related to Third Parties**\n\n** **\n\n**We may rely on third parties to conduct\nour clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or comply\nwith regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates. **\n\n \n\nWe do not have the ability\nto independently conduct our clinical trials for our product candidates and we must rely on third parties, such as contract research organizations,\nmedical institutions, clinical investigators and contract laboratories to conduct such trials. Our reliance on these third parties for\nclinical development activities results in reduced control over these activities. Moreover, the FDA requires us to comply with regulations\nand standards, commonly referred to as GCPs (good clinical practices), for conducting, recording and reporting the results of clinical\ntrials to assure that data and reported results are credible and accurate and that the trial participants are adequately protected. Our\nreliance on third parties does not relieve us of these responsibilities and requirements. If we or any of our third-party contractors\nfail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable\nforeign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot\nassure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials\ncomplies with GCP regulations. In addition, our clinical trials must be conducted with product produced under current good manufacturing\npractice, or cGMP, regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay\nthe regulatory approval process.\n\n \n\nIf our consultants, contract\nresearch organizations and other similar entities with which we are working do not successfully carry out their contractual duties, meet\nexpected deadlines, or comply with applicable regulations, we may be required to replace them. Although we believe that there are a number\nof other third-party contractors we could engage to continue these activities, we may not be able to enter into arrangements with alternative\nthird-party contractors or to do so on commercially reasonable terms, which may result in a delay of our planned clinical trials and delayed\ndevelopment of our product candidates.\n\n \n\nIn addition, our third-party\ncontractors are not our employees, and except for remedies available to us under our agreements with such third-party contractors, we\ncannot control whether or not they devote sufficient time and resources to our programs. If these third parties do not successfully carry\nout their contractual duties or regulatory obligations or meet expected deadlines, or if the quality or accuracy of the data they obtain\nis compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our preclinical\ndevelopment activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory\napproval for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results\nand prospects would be adversely affected.\n\n \n\n64\n\n \n\n \n\n**The protection against generic competition\nfor our biologic drug candidates and reimbursement by CMS may be subject to future change**\n\n \n\nWe are not aware of any existing\nor pending regulations or legislation that pertains to generic radiopharmaceutical products such as our targeted radiotherapy product\ncandidates. Our ARC product candidates are regulated by the FDA as biologic products, and we intend to seek approval for these products\npursuant to the BLA pathway. The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated pathway for\nthe approval of biosimilar and interchangeable biologic products. The abbreviated regulatory pathway establishes legal authority for the\nFDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based\non its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA\nuntil 12 years after the original branded product was approved under a BLA and in Europe a biosimilar product cannot be approved until\n10 years after the original branded product was approved. The law is complex and as a result, its ultimate impact, implementation, and\nmeaning are subject to uncertainty. Even if a biosimilar gets approved for one of the antibodies that we use, the final constructs of\nour drug candidates consist of an antibody, radioisotope and in some cases a linker and we are not aware of any regulations that would\nrequire us to provide the final constructs or components to third parties or potential competitors. Therefore, based on the current regulations,\nwe do not believe that the final drug product of our candidates can be subject to competition from a biosimilar as outlined in BPCIA for\nat least 12 years in the U.S. and 10 years in the EU. We are aware that generic versions of certain radiopharmaceuticals utilizing peptides\nhave been submitted to the FDA via the Abbreviated New Drug Application (“ANDA”) pathway, however, those products are not\ncovered under the BPCIA and therefore that generic pathway is not applicable to Iomab-B or Actimab-A. We expect this would also apply\nto other biologic drug candidates we may seek to develop in the future based on the current provisions of the BPCIA. Additionally, the\nInflation Reduction Act (“IRA”) that was enacted in August 2022, states that reimbursement by the Centers for Medicare &\nMedicaid Services (“CMS”) for high-expenditure single-source biologic drugs, which we expect Iomab-B and Actimab-A to be,\ncan only be negotiated after at least 11 years following approval compared to 7 years for non-biologic drugs with negotiated prices taking\neffect two years after selection. Therefore, we currently believe that our antibody radiation conjugates (“ARCs”) are less\nlikely than small molecules to face pricing pressure and negotiation from IRA. Further, a drug or biological product that has an orphan\ndrug designation, which Iomab-B and Actimab-A both have, for only one rare disease or condition will be excluded from the IRA’s\nprice negotiations requirements  until such time the biological products has designations for more than one rare disease or condition,\nor if is approved for an indication that is not within that single designated rare disease or condition, unless such additional designation\nor such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation. In August 2023, 10 initial\ndrugs were identified with negotiated prices that went into effect January 1, 2026. In 2027 and 2028, it is expected that CMS will establish\nnegotiated prices for 15 additional drugs in each respective year. We do not believe there is a high likelihood that Iomab-B or Actimab-A\nwould be identified by CMS for negotiated pricing under IRA but there is potential that IRA and other additional state and federal healthcare\nreform measures will be adopted in the future and the implementation of cost-containment measures or other healthcare reforms may prevent\nus from being able to generate revenue, attain profitability or successfully commercialize our product candidates.\n\n \n\n**Our product candidates may never achieve\nmarket acceptance.**\n\n \n\nActimab-A, Iomab-ACT, ATNM-400,\nIomab-B and future product candidates that we may develop may never gain market acceptance among physicians, patients and the medical\ncommunity. The degree of market acceptance of any of our products will depend on a number of factors, including the actual and perceived\neffectiveness and reliability of the product; the results of any long-term clinical trials relating to use of the product; the availability,\nrelative cost and perceived advantages and disadvantages of alternative technologies; the degree to which treatments using the product\nare approved for reimbursement by public and private insurers; the strength of our marketing and distribution infrastructure; and the\nlevel of education and awareness among physicians and hospitals concerning the product.\n\n \n\nWe believe that oncologists\nand other physicians will not widely adopt a product candidate unless they determine, based on experience, clinical data, and published\npeer-reviewed journal articles, that the use of that product candidate provides an effective alternative to other means of treating specific\ncancers. Patient studies or clinical experience may indicate that treatment with our product candidates does not provide patients with\nsufficient benefits in extension of life or quality of life. We believe that recommendations and support for the use of each product candidate\nfrom influential physicians will be essential for widespread market acceptance. Our product candidates are still in the development stage,\nand it is premature to attempt to gain support from physicians at this time. We can provide no assurance that such support will ever be\nobtained. If our product candidates do not receive such support from these physicians and from long-term data, physicians may not use\nor continue to use, and hospitals may not purchase or continue to purchase, them.\n\n \n\n65\n\n \n\n \n\nFailure of Actimab-A, Iomab-ACT,\nATNM-400, Iomab-B or any of our other product candidates to significantly penetrate current or new markets would negatively impact our\nbusiness financial condition and results of operations.\n\n \n\n**We may be subject to claims that our third-party\nservice providers, consultants or current or former employees have wrongfully used or disclosed confidential information of third parties.**\n\n \n\nWe have received confidential\nand proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology\nor pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently\nor otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation may\nbe necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial\ncost and be a distraction to our management and employees. \n\n \n\n**We currently depend\non single third-party manufacturers to produce our preclinical and clinical trial drug supplies. Any disruption in the operations of\nour current third-party manufacturers, or other third-party manufacturers we may engage in the future, could adversely affect our business\nand results of operations.**  \n\n \n\nWe do not currently operate manufacturing facilities for preclinical\nor clinical production of any of our product candidates. We rely on third-party manufacturers to supply, store, and distribute preclinical\nand clinical supply of the components of our drug product candidates including monoclonal antibodies, linkers and radioisotopes, as well\nas the final construct which comprises our drug product candidates. We expect to continue to depend on third-party manufacturers for the\nforeseeable future. Any performance failure on the part of our existing or future manufacturers could delay clinical development, cause\nus to suspend or terminate development or delay or prohibit regulatory approval of our product candidates or commercialization of any\napproved products. Further avenues of disruption to our clinical or eventual commercial supply may also occur due to the sale, acquisition,\nbusiness reprioritization, bankruptcy or other unforeseen circumstances that might occur at any of our suppliers or contract manufacturing\npartners including an inability to come to terms on renewal of existing contracts or new contracts.\n\n \n\nWe currently rely on single manufacturers to manufacture our preclinical\nand clinical trial drug supplies. With a view to maintaining business continuity we are evaluating alternatives and second and even third\nsources of supply or manufacturing for our core suppliers and manufacturing partners, however there can be no assurances that we will\nbe able to identify such suppliers or partners and assuming we did, that we would be able to enter into contracts that are on favorable\nterms or on terms that will enable sufficient supply to ensure business continuity and support our growth plans.\n\n \n\nOur product candidates require\nprecise, high-quality manufacturing. Failure by our current contract manufacturer or other third-party manufacturers we may engage in\nthe future to achieve and maintain high manufacturing standards could result in patient injury or death, product recalls or withdrawals,\ndelays or failures in testing or delivery, cost overruns, or other problems that could seriously hurt our business. Contract manufacturers\nmay encounter difficulties involving production yields, quality control, and quality assurance. These manufacturers are subject to ongoing\nperiodic and unannounced inspections by the FDA and corresponding state and foreign agencies to ensure strict compliance with cGMPs and\nother applicable government regulations and corresponding foreign standards; we do not have control over third-party manufacturers’\ncompliance with these regulations and standards.\n\n \n\nWe currently plan to build\nout a manufacturing facility in the future to operate for the purposes of manufacturing our own products. We have never built, owned or\noperated a manufacturing facility. There can be no assurances that we will be able to successfully accomplish this and in doing so we\nmay experience delays, cost overruns, or other problems that could seriously hurt our business. Even if we successfully build out our\nplanned manufacturing facility, we may not realize the expected benefits of these efforts.\n\n \n\n66\n\n \n\n \n\nWe depend on vendors with specialized operations, equipment and know-how\nto manufacture the respective components of our drug candidates. We have entered into manufacturing and supply agreements with these third-parties,\nand in some instances, we have agreed that such vendor be the exclusive manufacturer and supplier. If any of the third-parties we depend\non encounter difficulties in their operations, fail to comply with required regulations or breach their contractual obligations it may\nbe difficult, or we may be unable to identify suitable alternative third-party manufacturers. While we identify and evaluate third-party\nmanufacturers from time to time, even if we do identify suitable alternative third-parties, we may fail to reach agreement on contractual\nterms, it may be prohibitively expensive and there can be no assurance that we can successfully complete technology transfer and development\nwork necessary, or complete the necessary work in a timely manner. Any of which could prevent us from commencing manufacturing with third-parties\nwhich could cause delays or suspension of our clinical trials and preclinical work that may have a negative impact on our business.\n\n \n\nFurthermore, these third-party\ncontractors, whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shutdowns, employee strikes, or\nany other unforeseeable acts that may delay or limit production. Our inability to adequately establish, supervise and conduct (either\nourselves or through third parties) all aspects of the formulation and manufacturing processes, and the inability of third-party manufacturers\nto consistently supply quality product when required would have a material adverse effect on our ability to develop or commercialize\nour products. We have faced delays and risks associated with reliance on key third party manufacturers in the past and may be faced with\nsuch delays and risks in the future. Any future manufacturing interruptions or related supply issues could have an adverse effect on\nour company, including delays in clinical trials. \n\n \n\n**If we are successful in obtaining marketing\napproval from the FDA and/or other regulatory agencies for any of our product candidates, we anticipate continued reliance on third-party\nmanufacturers.**\n\n \n\nTo date, our product candidates\nhave been manufactured in small quantities for preclinical and clinical testing by third-party manufacturers. If the FDA or other regulatory\nagencies approve any of our product candidates for commercial sale, we expect that we would continue to rely, at least initially, on third-party\nspecialized manufacturers to produce commercial quantities of approved products. These manufacturers may not be able to successfully increase\nthe manufacturing capacity for any approved product in a timely or economic manner, or at all. Significant scale-up of manufacturing may\nrequire additional validation studies, which the FDA must review and approve. Scale-up for commercial product may require financial commitment\nor investment by us, which we may not have sufficient capital for or may elect not to undertake. If third party manufacturers are unable\nto successfully increase the manufacturing capacity for a product candidate, or we are unable to establish our own manufacturing capabilities,\nthe commercial launch of any approved products may be delayed or there may be a shortage in supply, which in turn could have a material\nadverse effect on our business.\n\n \n\nIn addition, the facilities\nused by our contract manufacturers to manufacture our product candidates must be approved by the FDA pursuant to inspections that will\nbe conducted after we submit a BLA to the FDA. We do not control the manufacturing process of, and are completely dependent on, our contract\nmanufacturing partners for compliance with cGMPs. If our contract manufacturers cannot successfully manufacture material that conforms\nto our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, they will not be able to secure\nand/or maintain regulatory approval for their manufacturing facilities. If the FDA or a comparable foreign regulatory authority does not\napprove these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need\nto find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for\nor market our product candidates, if approved.\n\n \n\n67\n\n \n\n \n\n**We may have conflicts with our partners\nthat could delay or prevent the development or commercialization of our product candidates.**\n\n \n\nWe may have conflicts with\nour partners, such as conflicts concerning the interpretation of preclinical or clinical data, pertaining to the global patient safety\nprofile or efficacy results of our products, the achievement of milestones, the interpretation of contractual obligations, payments for\nservices, development obligations or the ownership of intellectual property developed during our collaboration. We may seek to amend,\nmodify or terminate agreements with partners, suppliers or service providers related to ATNM-400, Actimab-A, Iomab-ACT or Iomab-B, but\nthere can be no assurance that we can do so successfully or negotiate terms that are favorable to us. Failure of which can increase the\nrisk of or result in litigation or alternative dispute resolution options taken against us. Further, we may exercise our decision-making\nauthority under certain circumstances pertaining to global patient safety related to our products, which our partners may disagree with\nand may result in potential conflicts and public disclosure of our rationale and position. If any conflicts arise with any of our partners,\nsuch partner may act in a manner that is adverse to our best interests. Any such disagreement could result in one or more of the following,\neach of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating\nrevenues: unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due under a collaboration; uncertainty\nregarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into\nadditional collaborations; unwillingness by the partner to cooperate in the development or manufacture of the product, including providing\nus with product data or materials; unwillingness on the part of a partner to keep us informed regarding the progress of its development\nand commercialization activities or to permit public disclosure of the results of those activities; initiating litigation or alternative\ndispute resolution options by either party to resolve the dispute; or attempts by either party to terminate the agreement. Litigation\nor alternative dispute resolution options can be lengthy and expensive, require significant time and attention from our management and\nare highly uncertain. There can be no assurance that if we pursue, or a partner pursues litigation or alternative dispute resolution options,\nthat we will prevail. Monetary and equitable damages awarded against us could have a material adverse effect on our business.\n\n \n\n**If in the future we are unable to establish\nU.S. or global sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates,\nwe may not be successful in commercializing our product candidates if they are approved and we may not be able to generate any revenue.**\n\n \n\nWe currently do not have a\nmarketing or sales team for the marketing, sales and distribution of any of our product candidates that may receive regulatory approval.\nIn order to commercialize any product candidates after approval, we must build on a territory-by-territory basis marketing, sales, distribution,\nmanagerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful\nin doing so. If our product candidates receive regulatory approval, we may decide to establish an internal sales or marketing team with\ntechnical expertise and supporting distribution capabilities to commercialize our product candidates, which will be expensive and time-consuming\nand will require significant attention of our executive officers to manage. Any failure or delay in the development of our internal sales,\nmarketing and distribution capabilities would adversely impact the commercialization of any of our product candidates that we obtain approval\nto market. \n\n \n\nWith respect to the commercialization\nof all or certain of our product candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with\nthird parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution\nsystems or in lieu of our own sales force and distribution systems. If we are unable to enter into or maintain such arrangements when\nneeded on acceptable terms, or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory\napproval or any such commercialization may experience delays or limitations. If we are not successful in commercializing our product candidates,\neither on our own or through collaborations with one or more third parties, our future product revenue will suffer and we may incur significant\nadditional losses.\n\n** **\n\n**We face significant competition from other\nbiotechnology and pharmaceutical companies.**\n\n \n\nOur product candidates face,\nand will continue to face, intense competition from large pharmaceutical and biotechnology companies, as well as academic and research\ninstitutions. We compete in an industry that is characterized by (i) rapid technological change, (ii) evolving industry standards, (iii)\nemerging competition and (iv) new product introductions. Our competitors have existing products and technologies that will compete with\nour product candidates and technologies and may develop and commercialize additional products and technologies that will compete with\nour product candidates and technologies. Because several competing companies and institutions have greater financial resources than us,\nthey may be able to (i) provide broader services and product lines, (ii) make greater investments in research and development, or R&D,\nand (iii) carry on broader R&D initiatives. Our competitors also have greater development capabilities than we do and have substantially\ngreater experience in undertaking preclinical and clinical testing of product candidates, obtaining regulatory approvals, and manufacturing\nand marketing pharmaceutical products. They also have greater name recognition and better access to customers than us.\n\n \n\n68\n\n \n\n \n\n**Our product candidates may cause undesirable\nside effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial\npotential, or result in significant negative consequences.**\n\n \n\nUndesirable side effects caused\nby our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more\nrestrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. The drug-related side\neffects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability\nclaims. Any of these occurrences may harm our business, financial condition and prospects significantly. Even if any of our product candidates\nreceives marketing approval, as greater numbers of patients use a product following its approval, an increase in the incidence of side\neffects or the incidence of other post-approval problems that were not seen or anticipated during pre-approval clinical trials could result\nin a number of potentially significant negative consequences, including:\n\n \n\n \n●\nregulatory authorities may withdraw their approval of the product;\n\n \n\n \n●\nregulatory authorities may require the addition of labeling statements, such as warnings or contraindications;\n\n \n\n \n●\nwe may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;\n\n \n\n \n●\nwe may elect, or we may be required, to recall or withdraw product from the market;\n\n \n\n \n●\nwe could be sued and held liable for harm caused to patients; and\n\n \n\n \n●\nour reputation may suffer.\n\n \n\nAny of these events could\nsubstantially increase the costs and expenses of developing, commercializing and marketing any such product candidates or could harm or\nprevent sales of any approved products.\n\n** **\n\n**Risks Related to Our Intellectual Property**\n\n** **\n\n**We depend upon securing and protecting critical\nintellectual property.**\n\n \n\nWe are dependent on obtaining\nand maintaining patents, trade secrets, copyright and trademark protection of our technologies in the United States and other jurisdictions,\nas well as successfully enforcing this intellectual property and defending this intellectual property against third-party challenges.\nThe degree of future protection of our proprietary rights is uncertain for product candidates that are currently in the early stages of\ndevelopment because we cannot predict which of these product candidates will ultimately reach the commercial market or whether the commercial\nversions of these product candidates will incorporate proprietary technologies.\n\n \n\n**Our patent position is highly uncertain\nand involves complex legal and factual questions.**\n\n \n\nAccordingly, we cannot predict\nthe breadth of claims that may be allowed or enforced under our patents or in third-party patents. For example, we or our licensors might\nnot have been the first to make the inventions covered by each of our pending patent applications and issued patents; we or our licensors\nmight not have been the first to file patent applications for these inventions; others may independently develop similar or alternative\ntechnologies or duplicate any of our technologies; it is possible that none of our pending patent applications or the pending patent applications\nof our licensors will result in issued patents; our issued patents and issued patents of our licensors may not provide a basis for commercially\nviable technologies, or may not provide us with any competitive advantages, or may be challenged and invalidated by third parties; and,\nwe may not develop additional proprietary technologies that are patentable.\n\n \n\nFurthermore, the issuance\nof a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide us\nwith adequate proprietary protection or competitive advantages against competitors with similar products. Competitors may also be able\nto design around our patents. Other parties may develop and obtain patent protection for more effective technologies, designs or methods.\nWe may not be able to prevent the unauthorized disclosure or use of our technical knowledge or trade secrets by consultants, vendors,\nformer employees and current employees.\n\n \n\n69\n\n \n\n \n\nPatent rights are territorial,\nand patent protection extends only to those countries where we have issued patents. Filing, prosecuting and defending patents on our products\nand product candidates in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual\nproperty rights in some countries outside the United States could be less extensive than those in the United States. Many countries, however,\ndo not protect intellectual property to the same extent as the U.S. or Europe, and their litigation processes differ. Competitors may\nsuccessfully challenge or avoid our patents, or manufacture products in countries where we have not applied for patent protection. Changes\nin the patent laws in the U.S. or other countries may diminish the value of our patent rights. As a result of these and other factors,\nthe scope, validity, enforceability, and commercial value of our patent rights are uncertain and unpredictable.\n\n \n\nIndeed, several companies\nhave encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems\nof some countries do not favor the enforcement of patents and other intellectual property rights, which could make it difficult for us\nto stop the infringement, misappropriation or other violation of our intellectual property rights generally. Proceedings to enforce our\nintellectual property rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other\naspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk\nof not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that are initiated, and\nthe damages or other remedies awarded, if any, may not be commercially meaningful.\n\n \n\nThe patent positions of pharmaceutical\ncompanies, including our patent position, involve complex legal and factual questions, and, therefore, the issuance, scope, validity and\nenforceability of any patent claims that we may obtain cannot be predicted with certainty. Patents, if issued, may be challenged, deemed\nunenforceable, invalidated, or circumvented. A third-party may submit prior art, or we may become involved in opposition, derivation,\nreexamination, inter partes review, post-grant review, supplemental examination, or interference proceedings challenging our patent rights\nor the patent rights of our licensors or development partners. The costs of defending or enforcing our proprietary rights in these proceedings\ncan be substantial, and the outcome can be uncertain. An adverse determination in any such submission or proceeding could reduce the scope\nof, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, or\nreduce our ability to manufacture or commercialize products. Furthermore, if the scope or strength of protection provided by our patents\nand patent applications is threatened, it could discourage companies from collaborating with us to license, develop or commercialize current\nor future products. The ownership of our proprietary rights could also be challenged.\n\n \n\nAs a result, our owned and\nlicensed patents may be held invalid, and we may not be able to obtain and enforce patents and to maintain trade secret protection for\nthe full commercial extent of our technology. The extent to which we are unable to do so could materially harm our business.\n\n \n\nWe or our licensors have applied\nfor and will continue to apply for patents for certain products and methods. Such applications may not result in the issuance of any patents,\nand any patents now held or that may be issued may not provide us with adequate protection from competition. Furthermore, it is possible\nthat patents issued or licensed to us may be challenged successfully. In that event, if we have a preferred competitive position because\nof such patents, such preferred position would be lost. If we are unable to secure or to continue to maintain a preferred position, we\ncould become subject to competition from the sale of generic products. Failure to receive, inability to protect, or expiration of our\npatents for medical use, manufacture, conjugation and labeling of Ac-225, the antibodies that we license from third parties, or subsequent\nrelated filings, would adversely affect our business and operations.\n\n \n\nPatents issued or licensed\nto us may be infringed by the products or processes of others. Our ability to enforce our patent rights depends on our ability to detect\ninfringement. It is difficult to detect infringers who do not advertise the components that are used in their products. Moreover, it may\nbe difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product, particularly\nin litigation in countries other than the U.S. that do not provide an extensive discovery procedure. Any litigation to enforce or defend\nour patent rights, if any, even if we were to prevail, could be costly and time-consuming and would divert the attention of our management\nand key personnel from our business operations. We may not prevail in any lawsuits that we initiate and the damages or other remedies\nawarded if we were to prevail may not be commercially meaningful.\n\n \n\n70\n\n \n\n \n\nThe cost of enforcing our\npatent rights against infringers, if such enforcement is required, could be significant, and we may not have the financial resources to\nfund such litigation. Further, such litigation can go on for years and the time demands could interfere with our normal operations. There\nhas been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical industry.\nWe may become a party to patent litigation and other proceedings. The cost to us of any patent litigation, even if resolved in our favor,\ncould be substantial. Some of our competitors may be able to sustain the costs of such litigation more effectively than we can because\nof their substantially greater financial resources. Litigation may also absorb significant management time.\n\n \n\nUnpatented trade secrets,\nimprovements, confidential know-how and continuing technological innovation are important to our scientific and commercial success. Although\nwe attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of\nconfidentiality agreements with our partners, collaborators, employees and consultants and other appropriate means, these measures may\nnot effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access\nto, the same or similar information. In addition, we cannot guarantee that we have executed these agreements with each party that may\nhave or have had access to our trade secrets. Furthermore, if the employees and consultants who are parties to these agreements breach\nor violate the terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade\nsecrets through such breaches or violations.\n\n \n\nCertain of our patent rights\nare licensed to us by third parties. If we fail to comply with the terms of these license agreements, our rights to those patents may\nbe terminated, and we may be unable to conduct our business.\n\n \n\n**If we are found to be infringing patents\nor trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue the\ndevelopment or sale of our products, and/or pay damages.**\n\n \n\nWe may not have identified\nall patents, published applications or published literature that affect our business either by blocking our ability to commercialize our\nproducts, by preventing the patentability of one or more aspects of our products to us or our licensors, or by covering the same or similar\ntechnologies that may affect our ability to market our products. For example, we (or our licensors) may not have conducted a patent clearance\nsearch sufficient to identify potentially obstructing third party patent rights. Moreover, patent applications in the United States are\nmaintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the\nU.S. Patent and Trademark Office, or the USPTO, for the entire time prior to issuance as a U.S. patent. Patent applications filed in countries\noutside of the United States are not typically published until at least 18 months from their first filing date. Similarly, publication\nof discoveries in the scientific or patent literature often lags behind actual discoveries. We cannot be certain that we or our licensors\nwere the first to invent, or the first to file, patent applications covering our products and candidates. We also may not know if our\ncompetitors filed patent applications for technology covered by our pending applications or if we were the first to invent the technology\nthat is the subject of our patent applications. Competitors may have filed patent applications or received patents and may obtain additional\npatents and proprietary rights that block or compete with our patents.\n\n \n\nOur manufacturing processes\nand potential products may violate proprietary rights of patents that have been or may be granted to competitors, universities or others,\nor the trade secrets of those persons and entities. As the pharmaceutical industry expands and more patents are issued, the risk increases\nthat our processes and potential products may give rise to claims that they infringe the patents or trade secrets of others. These other\npersons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the\naffected product or process. If any of these actions are successful, in addition to any potential liability for damages, we could be required\nto obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the affected process.\nRequired licenses may not be available on acceptable terms, if at all, and the results of litigation are uncertain. If we become involved\nin litigation or other proceedings, it could consume a substantial portion of our financial resources and the efforts of our personnel.\n\n \n\nIn addition to infringement\nor other intellectual property claims against us, we may become a party to other patent litigation or proceedings before regulatory agencies,\nincluding post-grant review, inter partes review, interference or re-examination proceedings filed with the U.S. Patent and Trademark\nOffice (or similar proceedings before corresponding tribunals in other jurisdictions) that challenge our patent rights or the patent rights\nof our licensors. The costs and efforts of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings\ncan be substantial and the outcome can be uncertain. An adverse determination in these proceedings could weaken or invalidate the patent\nclaims that cover our technology, which adverse determination could harm our business significantly and dissuade companies from collaborating\nwith us or permit third parties to directly compete with the same technology. \n\n \n\n71\n\n \n\n \n\n**Our ability to protect and enforce our patents\ndoes not guarantee that we will secure the right to commercialize our potential products and respective patents.**\n\n \n\nA patent is a limited monopoly\nright conferred upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious invention.\nThis monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making, using and/or selling\nits invention. While a patent gives the holder this right to exclude others, it is not a license to commercialize an invention covered\nby the patent where other permissions may be required for commercialization to occur. For example, a drug cannot be marketed without the\nappropriate authorization from the FDA, regardless of the existence of a patent covering the product. Further, the invention, even if\npatented itself, cannot be commercialized if it infringes the valid patent rights of another party. \n\n \n\n**We rely on confidentiality agreements to\nprotect our trade secrets. If these agreements are breached by our employees or other parties, our trade secrets may become known to our\ncompetitors.**\n\n \n\nWe rely on trade secrets that\nwe seek to protect through numerous measures, including non-compete and confidentiality agreements with our employees and other parties.\nIf these agreements are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us. Any remedies\nthat may be available to us may not be adequate to protect our business or compensate us for the damaging disclosure. In addition, we\nmay have to expend resources to protect our interests from possible infringement by others.\n\n \n\n**We may be subject to damages resulting from\nclaims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.**\n\n \n\nOur employees may have been\npreviously employed at other companies in the industry, including our competitors or potential competitors. Although we are not aware\nof any claims currently pending against us, we may be subject to claims that these employees or we have inadvertently or otherwise used\nor disclosed trade secrets or other proprietary information of the former employers of our employees. Litigation may be necessary to defend\nagainst these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be\na distraction to management. If we fail in defending such claims, in addition to paying money claims, we may lose valuable intellectual\nproperty rights or personnel. A loss of key personnel or their work product could hamper or prevent our ability to commercialize product(s),\nwhich would materially adversely affect our commercial development efforts. \n\n \n\n**Obtaining and maintaining patent protection\ndepends on compliance with various procedures and other requirements, and our patent protection could be reduced or eliminated in case\nof non-compliance with these requirements.**\n\n** **\n\nPeriodic maintenance fees,\nrenewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to the relevant patent agencies\nin several stages over the lifetime of the patents and/or applications. The relevant patent agencies require compliance with a number\nof procedural, documentary, fee payment and other provisions during the patent application process. In many cases, an inadvertent lapse\ncan be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which\nthe failure to comply with the relevant requirements can result in the abandonment or lapse of the patent or patent application, resulting\nin partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to use our\ntechnologies and know-how which could have a material adverse effect on our business, prospects, financial condition and results of operation. \n\n \n\n72\n\n \n\n \n\n**Risks Related to Our Operations**\n\n \n\n**Managing our growth as we expand operations\nmay strain our resources.**\n\n \n\nWe expect to need to grow\nrapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our product candidates as well\nas potential commercial operations in the future, which will place a significant strain on our financial, managerial and operational resources.\nIn order to achieve and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities.\nMoreover, we will need to increase staffing and to train, motivate and manage our employees. All of these activities will increase our\nexpenses and may require us to raise additional capital sooner than expected. Failure to manage growth effectively could materially harm\nour business, financial condition or results of operations.\n\n \n\n**The use of hazardous materials, including\nradioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us\nto liability for claims arising from the use or misuse of these materials.**\n\n \n\nOur research, development\nand manufacturing activities involve the controlled use of hazardous materials, including chemicals, radioactive and biological materials,\nsuch as radioactive isotopes. We are subject to federal, state, local and foreign environmental laws and regulations governing, among\nother matters, the handling, transportation, storage, use and disposal of these materials and some waste products. Our radiopharmaceutical\noperations depend on NRC/Agreement State licenses, hazardous-materials shipping permissions, and third-party radioactive waste services;\nloss or disruption of any of these could halt clinical supply or commercialization. We cannot completely eliminate the risk of contamination\nor injury from these materials, and we could be held liable for any damages that result, which could exceed our financial resources. We\ncurrently maintain insurance coverage for injuries resulting from the hazardous materials we use; however, future claims may exceed the\namount of our coverage. Also, we do not have insurance coverage for pollution cleanup and removal. Currently the costs of complying with\nsuch federal, state, local and foreign environmental regulations are not significant, and consist primarily of waste disposal expenses.\nHowever, they could become expensive, and current or future environmental laws or regulations may impair our research, development, production\nand commercialization efforts.  \n\n** **\n\n**We may undertake international operations,\nwhich will subject us to risks inherent with operations outside of the United States.**\n\n \n\nAlthough we do not have any\ninternational operations at this time, we intend to seek market clearances in foreign markets that we believe will generate significant\nopportunities. However, even with the cooperation of a commercialization partner, conducting drug development in foreign countries involves\ninherent risks, including, but not limited to difficulties in staffing, funding and managing foreign operations; unexpected changes in\nregulatory requirements; export restrictions; tariffs and other trade barriers; difficulties in protecting, acquiring, enforcing and litigating\nintellectual property rights; fluctuations in currency exchange rates; and potentially adverse tax consequences.\n\n \n\nIf we were to experience any\nof the difficulties listed above, or any other difficulties, any international development activities and our overall financial condition\nmay suffer and cause us to reduce or discontinue our international development and registration efforts.\n\n \n\n**We expect to expand our development and\nregulatory capabilities and potentially implement sales, marketing and distribution capabilities, and, as a result, we may encounter difficulties\nin managing our growth, which could disrupt our operations.**\n\n \n\nWe expect to experience growth\nin the number of our employees and the scope of our operations, particularly in the areas of product candidate development, regulatory\naffairs and, if any of our product candidates receives marketing approval, sales, marketing, and distribution.\n\n  \n\nWe currently do not have a\nmarketing or sales team for the marketing, sales and distribution of any of our product candidates that are potentially able to obtain\nregulatory approval. In order to commercialize any product candidates, we must build on a territory-by-territory basis marketing, sales,\ndistribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we\nmay not be successful in doing so. If our product candidates receive regulatory approval, we intend to establish an internal sales or\nmarketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates, which will be\nexpensive and time consuming and will require significant attention of our executive officers to manage. We will also have to compete\nwith other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. Any failure or\ndelay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of\nany of our product candidates that we obtain approval to market.\n\n \n\n73\n\n \n\n \n\nTo manage our anticipated\nfuture growth, we must continue to implement and improve our managerial, operational, and financial systems, expand our facilities, and\ncontinue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our\nmanagement team in managing a public company with such anticipated growth, we may not be able to effectively manage the expansion of our\noperations or recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may\ndivert our management and business development resources. Any inability to manage growth could delay the execution of our business plans\nor disrupt our operations.\n\n \n\n**We continuously evaluate our business strategy\nand may modify our strategy as necessary to respond to developments in our business and other factors, and any such modification such\nas a divestiture, spin-off, spin-out, merger or acquisition, if not successful, could have a material adverse effect on our business,\nfinancial condition, and results of operations.**\n\n** **\n\nWe continuously evaluate our\nbusiness strategy and modify our plans as necessary to achieve our objectives in response to changing circumstances. As part of such a\nprocess, we may delay, modify or discontinue the development of certain of our drug candidates and choose alternative approaches if we\nbelieve such changes would be in our best interest. We may also expand or alter our research and development activities from time to time\nand redirect allocation of our resources. We have implemented such changes in our business strategy and may continue to do so in the future.\nThere can be no assurances that any product development or other changes that we implement will be successful or that, after implementation\nof any such changes, that we will not refocus our efforts on new or different objectives.\n\n \n\n**We may expand our business through the acquisition\nof rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’\nownership interests in our company.**\n\n \n\nOur business strategy includes\nexpanding our products and capabilities, and we may seek acquisitions of product candidates, antibodies or technologies to do so. Acquisitions\ninvolve numerous risks, including substantial cash expenditures; potentially dilutive issuance of equity securities; incurrence of debt\nand contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition; difficulties in assimilating\nacquired technologies or the operations of the acquired companies; diverting our management’s attention away from other business\nconcerns; risks of entering markets in which we have limited or no direct experience; and the potential loss of our key employees or key\nemployees of the acquired companies.\n\n \n\nWe can make no assurances\nthat any acquisition will result in short-term or long-term benefits to us. We may incorrectly judge the value or worth of an acquired\nproduct, company or business. In addition, our future success would depend in part on our ability to manage the rapid growth associated\nwith some of these acquisitions. We cannot assure that we will be able to make the combination of our business with that of acquired products,\nbusinesses or companies work or be successful. Furthermore, the development or expansion of our business or any acquired products, business\nor companies may require a substantial capital investment by us. We may not have these necessary funds, or they might not be available\nto us on acceptable terms or at all. We may also seek to raise funds by selling shares of our preferred or common stock, which could dilute\neach current stockholder’s ownership interest in the Company.\n\n \n\n**Risks Related to Ownership of Our Common Stock**\n\n \n\n**The sale of securities by us in any equity\nor debt financing could result in dilution to our existing stockholders and have a material adverse effect on our earnings.**\n\n \n\nWe have financed our operations\nprimarily through sales of stock and warrants. It is likely that during the next twelve months we will seek to raise additional capital\nthrough the sales of stock and warrants in order to expand our level of operations to continue our research and development efforts.\n\n \n\nAny sale of common stock by\nus in a future offering could result in dilution to our existing stockholders as a direct result of our issuance of additional shares\nof our capital stock. In addition, our business strategy may include expansion through internal growth or by establishing strategic relationships\nwith targeted customers and vendors. In order to do so, or to finance the cost of our other activities, we may issue additional equity\nsecurities that could dilute our stockholders’ stock ownership. We may also assume additional debt and incur impairment losses related\nto goodwill and other tangible assets if we acquire another company and this could negatively impact our earnings and results of operations.\n\n \n\n74\n\n \n\n \n\n**Our common stock is subject to price volatility\nwhich could lead to losses by stockholders and potential costly security litigation.**\n\n \n\nThe trading volume of our\ncommon stock has been and may continue to be extremely limited and sporadic. We expect the market price of our common stock to fluctuate\nsubstantially due to a variety of factors, including market perception of our ability to achieve our planned growth, quarterly operating\nresults of other companies in the same industry, trading volume in our common stock, changes in general conditions in the economy and\nthe financial markets or other developments affecting our competitors or us. This volatility has had a significant effect on the market\nprice of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our\ncommon stock.\n\n \n\n**The trading price of our common stock may\nbe highly volatile and could fluctuate in response to factors such as:**\n\n \n\n \n●\nactual or anticipated variations in our operating results;\n\n \n\n \n●\nannouncements of developments by us or our competitors;\n\n \n\n \n●\nthe timing of IND and/or BLA approval, the completion and/or results of our clinical trials;\n\n \n\n \n●\nregulatory actions regarding our products;\n\n \n\n \n●\nannouncements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;\n\n \n\n \n●\nadoption of new accounting standards affecting our industry;\n\n \n\n \n●\nadditions or departures of key personnel;\n\n \n\n \n●\nintroduction of new products by us or our competitors;\n\n \n\n \n●\nsales of our common stock or other securities in the open market;\n\n \n\n \n●\ninaccurate or unfavorable reports from securities or industry analysts; and\n\n \n\n \n●\nother events or factors, many of which are beyond our control.\n\n \n\nThe stock market is subject to significant price and volume fluctuations.\nIn the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has\noften been initiated against such a company. Litigation initiated against us, such as the matters further described under “Legal\nProceedings,” whether or not successful, could result in substantial costs and diversion of our management’s attention and\nour resources, which could harm our business and financial condition.\n\n \n\n**We do not intend to pay dividends on our\ncommon stock, so any returns will be determined by the value of our common stock.**\n\n \n\nWe have never declared or\npaid any cash dividends on our common stock. For the foreseeable future, it is expected that earnings, if any, generated from our operations\nwill be used to finance the growth of our business, and that no dividends will be paid to holders of our common stock. As a result, the\nsuccess of an investment in our common stock will depend upon any future appreciation in its value. There is no guarantee that our common\nstock will appreciate in value.\n\n  \n\n**Certain provisions\nof our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover\nmore difficult to complete, even if such a transaction were in our stockholders’ interest.**\n\n \n\nProvisions of our Certificate\nof Incorporation and Bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our\nmanagement, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our\nstockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our stock.\nAmong other things, the certificate of incorporation and Bylaws:\n\n \n\n \n●\nprovide that the authorized number of directors may be changed by resolution of the Board of Directors;\n\n \n\n \n●\nprovide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;\n\n \n\n75\n\n \n\n \n\n \n●\ndivide the Board of Directors into three classes;\n\n \n\n \n●\nprovide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice.\n\n \n\nIn addition, we are governed\nby Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a public Delaware corporation from engaging\nin a “business combination” with an “interested stockholder” for a period of three years after the date of the\ntransaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.\nA “business combination” includes mergers, asset sales or other transactions resulting in a financial benefit to the stockholder.\nAn “interested stockholder” is a person who, together with affiliates and associates, owns, or within three years, did own,\n15% or more of the corporation’s outstanding voting stock. These provisions may have the effect of delaying, deferring or preventing\na change in our control.\n\n \n\n**General Risk Factors**\n\n \n\n**We face risks associated with litigation\nand claims.**\n\n** **\n\nWe are subject to certain\nlegal proceedings, as further described under “Legal Proceedings.” In addition, from time to time, we may become involved\nin various claims, disputes and legal or regulatory proceedings that arise in the ordinary course of business and relate to contractual\nand other obligations. Due to the uncertainties of litigation, we can give no assurance that we will prevail on any claims made against\nus in any such lawsuit. Also, we can give no assurance that any other lawsuits or claims brought in the future will not have an adverse\neffect on our financial condition, liquidity, or operating results. Adverse outcomes in some or all of these claims may result in significant\nmonetary damages that could adversely affect our ability to conduct our business.\n\n \n\n**Compliance with the reporting requirements\nof federal securities laws can be expensive.**\n\n \n\nWe are subject to the information\nand reporting requirements of the Exchange Act and other federal securities laws, and the compliance obligations of the Sarbanes-Oxley\nAct. The costs of preparing and filing annual and quarterly reports and other information with the SEC and furnishing audited reports\nto stockholders are substantial. In addition, we will incur substantial expenses in connection with the preparation of registration statements\nand related documents with respect to any offerings of our common stock.\n\n \n\n**Our ability to utilize\nour net operating loss carryforwards and certain other tax attributes may be limited.**\n\n \n\nOur ability to utilize our federal net operating loss and tax credit\ncarryforwards may be limited under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”). The\nlimitations apply if we experience an “ownership change”, generally defined as a greater than 50 percentage point change in\nthe ownership of our equity by certain stockholders over a rolling three-year period. Similar provisions of state tax law may also\napply. We have not assessed whether such an ownership change has previously occurred. If we have experienced an ownership change\nat any time since our formation, we may already be subject to limitations on our ability to utilize our existing net operating losses\nand other tax attributes to offset taxable income. In addition, future changes in our stock ownership, which may be outside of our control,\nmay trigger an ownership change and, consequently, the limitations under Sections 382 and 383 of the Code. As a result, if or when\nwe earn net taxable income, our ability to use our pre-change net operating loss carryforwards and other tax attributes to offset such\ntaxable income may be subject to limitations, which could adversely affect our future cash flows.\n\n  \n\n**Failure to establish and maintain adequate\nfinance infrastructure and accounting systems and controls could impair our ability to comply with the financial reporting and internal\ncontrols requirements for publicly traded companies.**\n\n** **\n\nAs a public company, we operate\nin an increasingly demanding regulatory environment, including with respect to more complex accounting rules. Company responsibilities\nrequired by the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, include establishing and maintaining corporate oversight\nand adequate internal control over financial reporting and disclosure controls and procedures. Effective internal controls are necessary\nfor us to produce reliable financial reports and are important to help prevent financial fraud.\n\n \n\n76\n\n \n\n \n\nOur compliance with Section\n404 of the Sarbanes-Oxley Act requires that we incur substantial accounting expense and expend significant management efforts. We complied\nwith Section 404 at December 31, 2025 and 2024 and while our testing did not reveal any material weaknesses in our internal controls,\nany material weaknesses in our internal controls in the future would be required us to remediate in a timely manner so as to be able to\ncomply with the requirements of Section 404 each year. If we are not able to comply with the requirements of Section 404 in a timely manner\neach year, we could be subject to sanctions or investigations by the SEC, NYSE American or other regulatory authorities which would require\nadditional financial and management resources and could adversely affect the market price of our common stock. Furthermore, if we cannot\nprovide reliable financial reports or prevent fraud, our business and results of operations could be harmed, and investors could lose\nconfidence in our reported financial information.\n\n \n\n**If securities or industry analysts do not\npublish research or publish inaccurate or unfavorable research about our business, the price of our common stock and trading volume could\ndecline.**\n\n \n\nThe trading market for our\ncommon stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Multiple\nsecurities and industry analysts currently cover us. If one or more of the analysts downgrade our common stock or publish inaccurate or\nunfavorable research about our business, the price of our common stock would likely decline. If one or more of these analysts cease coverage\nof us or fail to publish reports on us regularly, demand for our common stock could decrease, which could cause the price of our common\nstock and trading volume to decline.\n\n** **\n\n**Our Bylaws designate the U.S. federal district\ncourts as the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act\nof 1933, as amended.**\n\n \n\nOur Bylaws provide that,\nunless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America will\nbe the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended. In\naddition, our Bylaws state that any person purchasing or otherwise acquiring any interest in our security shall be deemed to have notice\nof and to have consented to such provision. Such choice of forum provision may limit a stockholder’s ability to bring a claim in\na judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such\nlawsuits, if successful, might benefit our stockholders. Stockholders who do bring a claim in the federal district courts of the United\nStates of America could face additional litigation costs in pursuing any such claim.\n\n \n\n**The uncertainty of tariff policies and potential\ncountermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations.**\n\n \n\nPresident Trump has increased,\nand has indicated his willingness to continue to increase, the use of tariffs by the U.S. to accomplish certain U.S. policy goals. In\nFebruary 2026, the U.S. Supreme Court ruled that tariffs imposed under the International Emergency Economic Powers Act (IEEPA) are unauthorized.\nIn response, the presidential administration announced its intention to invoke other laws to collect tariffs and announced new tariffs\non imports from all countries under Section 122 of the Trade Act of 1974, in addition to any existing non-IEEPA tariffs. The administration\ncould additionally take action to invoke other laws to collect tariffs also. Such tariffs and any countermeasures could increase the cost\nof raw materials and components necessary for our operations, disrupt our global supply chain and create additional operational challenges.\nFurther, it is possible that government policy changes and related uncertainty about policy changes could increase market volatility.\nBecause of these dynamics, we cannot predict the impact of any future changes to the U.S.’s or other countries’ trading relationships\nor the impact of new laws or regulations adopted by the U.S. or other countries on our business. Such changes in tariffs and trade regulations\ncould have a material adverse effect on our financial condition, results of operations and cash flows."}