{"url_path":"/sec/glsi/10-k/2026/item-1a","section_key":"item-1a","section_title":"Item 1A RISK FACTORS**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-06-01","source_url":"https://www.sec.gov/Archives/edgar/data/1799788/0001493152-26-026651-index.html","accession_number":"0001493152-26-026651","cik":"0001799788","ticker":"GLSI","issuer_name":"Greenwich LifeSciences, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1799788/0001493152-26-026651-index.html","primary_entity_key":"0001799788","primary_entity_name":"Greenwich LifeSciences, Inc."},"word_count":27034,"has_tables":true,"body_markdown":"**ITEM\n1A. RISK FACTORS**\n\n \n\n*An\ninvestment in our securities involves a high degree of risk. An investor should carefully consider the risks described below as well\nas other information contained in this Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission\n(“SEC”). The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not\npresently known to us or that we currently believe are immaterial may also impair our business operations. If any of the following risks\nactually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our securities\ncould decline, and investors in our company may lose all or part of their investment.*\n\n \n\n**Risks\nRelating to Our Financial Position and Capital Needs**\n\n \n\n**We\nhave incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses\nfor the foreseeable future.**\n\n \n\nWe\nare a clinical stage biopharmaceutical company focused on the development of our novel cancer immunotherapy GP2, for breast cancer and\npotentially for a broad range of other HER2/*neu*-expressing cancers. Investment in biopharmaceutical product development is highly\nspeculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove\neffective, gain regulatory approval or become commercially viable. We do not have any products approved by regulatory authorities and\nhave not generated any revenues from collaboration and licensing agreements or product sales to date, and have incurred significant research,\ndevelopment and other expenses related to our ongoing operations and expect to continue to incur such expenses. As a result, we have\nnot been profitable and have incurred significant operating losses since our inception. For the years ended December 31, 2025 and 2024,\nwe reported a net loss of $19.4 million and $17.4 million, respectively. As of December\n31, 2025, we had an accumulated deficit of $87.1 million.\n\n \n\nWe\ndo not expect to generate revenues for many years, if at all. We expect to continue to incur significant expenses and operating losses\nfor the foreseeable future. We anticipate these losses to increase as we continue to research, develop and seek regulatory approvals\nfor our product candidate and any additional product candidates we may acquire, and potentially begin to commercialize product candidates\nthat may achieve regulatory approval. We may also encounter unforeseen expenses, difficulties, complications, delays and other unknown\nfactors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth\nof our expenses and our ability to generate revenues. Our expenses will further increase as we:\n\n \n\n \n●\nconduct\nclinical trials of our lead product candidate, GP2;\n\n \n \n \n\n \n●\nin-license\nor acquire the rights to, and pursue development of, other products, product candidates or technologies;\n\n \n \n \n\n \n●\nhire\nadditional clinical, manufacturing, quality control, quality assurance and scientific personnel;\n\n \n \n \n\n \n●\nseek\nmarketing approval for any product candidates that successfully complete clinical trials;\n\n \n \n \n\n \n●\ndevelop\nour outsourced manufacturing and commercial activities and establish sales, marketing and distribution capabilities, if we receive,\nor expect to receive, marketing approval for any product candidates;\n\n \n \n \n\n \n●\nmaintain,\nexpand and protect our intellectual property portfolio; and\n\n \n \n \n\n \n●\nadd\noperational, financial and management information systems and personnel.\n\n \n\n23\n\n[Table of Contents](#toc_001)\n\n** **\n\n**We\nneed significant additional financing to fund our operations and complete the development and, if approved, the commercialization of\nour product candidate. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development\nprograms or commercialization efforts.**\n\n \n\nOur existing cash will not be sufficient to complete\ndevelopment and obtain regulatory approval for our product candidate, and we will need to raise significant additional capital to help\nus do so. In addition, our operating plan may change as a result of many factors currently unknown to us, and we may need additional\nfunds sooner than planned.\n\n \n\nWe\nexpect to expend substantial resources for the foreseeable future to continue the clinical development and manufacturing of our product\ncandidate and the advancement and expansion of our preclinical research pipeline. These expenditures will include costs associated with\nresearch and development, potentially acquiring new product candidates or technologies, conducting preclinical studies and clinical trials\nand potentially obtaining regulatory approvals and manufacturing products, as well as marketing and selling products approved for sale,\nif any.\n\n \n\nThe\ntotal cost to complete an interim analysis and file a BLA application for drug approval in the U.S. could exceed $30 million; however,\nwe believe that we have budget flexibility with respect to the design of the Phase III clinical trial. We believe that we may be able\nto alter the cost of our Phase III clinical trial by adjusting the enrollment rate, the number of patients, and/or the number of immunological\nassays. While our budget for such Phase III trial may be flexible, our ability to reduce or modify costs may be adversely affected by,\namong other things, unexpected or higher costs associated with the trial, time required to complete the trial and other factors that\nmay be beyond our control. Our budgets and future capital requirements depend on many factors, including:\n\n \n\n \n●\nthe\nscope, progress, results and costs of our ongoing and planned development programs for our product candidate, as well as any additional\nclinical trials we undertake to obtain data sufficient to seek marketing approval for our product candidate;\n\n \n \n \n\n \n●\nthe\ntiming of, and the costs involved in, obtaining regulatory approvals for our product candidate if our clinical trials are successful;\n\n \n \n \n\n \n●\nthe\ncost of commercialization activities for our product candidate, if our product candidate is approved for sale, including marketing,\nsales and distribution costs;\n\n \n \n \n\n \n●\nthe\ncost of manufacturing our product candidate for clinical trials in preparation for regulatory approval, including the cost and timing\nof process development, manufacturing scale-up and validation activities;\n\n \n \n \n\n \n●\nour\nability to establish and maintain strategic licensing or other arrangements and the financial terms of such agreements;\n\n \n \n \n\n \n●\nthe\ncosts to in-license future product candidates or technologies;\n\n \n \n \n\n \n●\nthe\ncosts involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation\ncosts and the outcome of such litigation;\n\n \n \n \n\n \n●\nthe\ncosts in defending and resolving future derivative and securities class action litigation;\n\n \n \n \n\n \n●\nour\noperating expenses; and\n\n \n \n \n\n \n●\nthe\nemergence of competing technologies or other adverse market developments.\n\n \n\nAdditional\nfunds may not be available when we need them on terms that are acceptable to us, or at all. We have no committed source of additional\ncapital. If adequate funds are not available to us on a timely basis, we may not be able to continue as a going concern or we may be\nrequired to delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for our product candidate\nor target indications, or delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities\nthat may be necessary to commercialize our product candidate.\n\n \n\n**We\nmay consider strategic alternatives in order to maximize stockholder value, including financings, strategic alliances, acquisitions or\nthe possible sale of the Company. We may not be able to identify or consummate any suitable strategic alternatives.**\n\n \n\nWe\nmay consider all strategic alternatives that may be available to us to maximize stockholder value, including financings, strategic alliances,\nacquisitions or the possible sale of the Company. We currently have no agreements or commitments to engage in any specific strategic\ntransactions, and our exploration of various strategic alternatives may not result in any specific action or transaction. To the extent\nthat this engagement results in a transaction, our business objectives may change depending upon the nature of the transaction. There\ncan be no assurance that we will enter into any transaction as a result of the engagement. Furthermore, if we determine to engage in\na strategic transaction, we cannot predict the impact that such strategic transaction might have on our operations or stock price. We\nalso cannot predict the impact on our stock price if we fail to enter into a transaction.\n\n \n\n24\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Raising\nadditional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our\nproduct candidate on unfavorable terms to us.**\n\n \n\nWe\nmay seek additional capital through a variety of means, including through private and public equity offerings and debt financings, collaborations,\nstrategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the\nsale of equity or convertible debt securities, or through the issuance of shares under management or other types of contracts, or upon\nthe exercise or conversion of outstanding derivative securities, the ownership interests of our stockholders will be diluted, and the\nterms of such financings may include liquidation or other preferences, anti-dilution rights, conversion and exercise price adjustments\nand other provisions that adversely affect the rights of our stockholders, including rights, preferences and privileges that are senior\nto those of our holders of common stock in the event of a liquidation. In addition, debt financing, if available, could include covenants\nlimiting or restricting our ability to take certain actions, such as incurring additional debt, making capital expenditures, entering\ninto licensing arrangements, or declaring dividends and may require us to grant security interests in our assets, including our intellectual\nproperty. If we raise additional funds through collaborations, strategic alliances, or marketing, distribution or licensing arrangements\nwith third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, product or product candidate\nor grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings\nwhen needed, we may need to curtail or cease our operations.\n\n \n\n**We\ncurrently have no source of revenues. We may never generate revenues or achieve profitability.**\n\n \n\nCurrently,\nwe do not generate any revenues from product sales or otherwise. Even if we are able to successfully achieve regulatory approval for\nour product candidate, we do not know when we will generate revenues or become profitable, if at all. Our ability to generate revenues\nfrom product sales and achieve profitability will depend on our ability to successfully commercialize products, including our current\nproduct candidate, GP2, and other product candidates that we may develop, in-license or acquire in the future. Our ability to generate\nrevenues and achieve profitability also depends on a number of additional factors, including our ability to:\n\n \n\n \n●\nsuccessfully\ncomplete development activities, including the necessary clinical trials;\n\n \n \n \n\n \n●\ncomplete\nand submit either Biologics License Applications, or BLAs, or New Drug Applications, or NDAs, to the FDA and obtain U.S. regulatory\napproval for indications for which there is a commercial market;\n\n \n \n \n\n \n●\ncomplete\nand submit applications to foreign regulatory authorities;\n\n \n \n \n\n \n●\nobtain\nregulatory approval in territories with viable market sizes;\n\n \n \n \n\n \n●\nobtain\ncoverage and adequate reimbursement from third parties, including government and private payors;\n\n \n \n \n\n \n●\nset\ncommercially viable prices for our product, if any;\n\n \n \n \n\n \n●\nestablish\nand maintain supply and manufacturing relationships with reliable third parties and/or build our own manufacturing facility and ensure\nadequate, legally globally compliant manufacturing of bulk drug substances and drug products to maintain that supply;\n\n \n \n \n\n \n●\ndevelop\ndistribution processes for our product candidate;\n\n \n \n \n\n \n●\ndevelop\ncommercial quantities of our product candidate, once approved, at acceptable cost levels; obtain additional funding, if required\nto develop and commercialize our product candidate;\n\n \n \n \n\n \n●\ndevelop\na commercial organization capable of sales, marketing and distribution for any products we intend to sell ourselves, in the markets\nin which we choose to commercialize on our own;\n\n \n \n \n\n \n●\nachieve\nmarket acceptance of our product;\n\n \n \n \n\n \n●\nattract,\nhire and retain qualified personnel; and\n\n \n \n \n\n \n●\nprotect\nour rights in our intellectual property portfolio.\n\n \n\nOur\nrevenues for any product candidate for which regulatory approval is obtained will be dependent, in part, upon the size of the markets\nin the territories for which it gains regulatory approval, the accepted price for the product, the ability to get reimbursement at any\nprice, and whether we own the commercial rights for that territory. If the number of our addressable disease patients is not as significant\nas our estimates, the indication approved by regulatory authorities is narrower than we expect, or the reasonably accepted population\nfor treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenues from sales\nof such products, even if approved. In addition, we anticipate incurring significant costs associated with commercializing any approved\nproduct candidate. As a result, even if we generate revenues, we may not become profitable and may need to obtain additional funding\nto continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be\nunable to continue our operations at planned levels and may be forced to reduce our operations.\n\n \n\n25\n\n[Table of Contents](#toc_001)\n\n** **\n\n**The\nTax Cuts and Jobs Act could adversely affect our business and financial condition.**\n\n \n\nH.R.\n1, “An Act to provide for reconciliation pursuant to title II and V of the concurrent resolution on the budget for fiscal year\n2018,” informally entitled the Tax Cuts and Jobs Act (“Tax Act”) enacted on December 22, 2017, among other things,\ncontains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to\na single rate of 21%, limitation of the tax deduction for interest expense to 30% of adjusted taxable income (except for certain small\nbusinesses), limitation of the deduction for net operating losses carried forward from taxable years beginning after December 31, 2017\nto 80% of current year taxable income and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced\nrates regardless of whether they are repatriated, elimination of U.S. tax on foreign earnings (subject to certain important exceptions),\nproviding immediate deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or\nrepealing many business deductions and credits (including reduction of tax credits under the Orphan Drug Act). Notwithstanding the reduction\nin the corporate income tax rate, the overall impact of the Tax Act is uncertain and our business and financial condition could be adversely\naffected. In addition, it is uncertain if and to what extent various states will conform to the Tax Act.\n\n \n\n**Our\nability to use net operating losses to offset future taxable income may be subject to limitations.**\n\n \n\nAs\nof December 31, 2025, we had federal net operating loss, or NOLs, carryforwards of approximately $44.2\nmillion. Our NOLs generated in tax years ending on or prior to December 31, 2017 are only permitted to be carried forward for 20 years\nunder applicable U.S. tax laws, and will begin to expire, if not utilized, beginning in 2027. These NOL carryforwards could expire unused\nand be unavailable to offset future income tax liabilities. Under the Tax Act, federal NOLs incurred in tax years ending after December\n31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited. It is uncertain if and to what extent\nvarious states will conform to the Tax Act, or whether any further regulatory changes may be adopted in the future that could minimize\nits applicability. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and certain corresponding provisions\nof state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change,\nby value, in the ownership of its equity over a three-year period, the corporation’s ability to use its pre-change NOL carryforwards\nand other pre-change tax attributes to offset its post-change income may be limited.\n\n \n\n**Risks\nRelated to the Development and Regulatory Approval of Our Product Candidate**\n\n \n\n**Clinical-stage\nbiopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which may entail\nsubstantial risk.**\n\n \n\nWe\nare a clinical-stage biopharmaceutical company with a product candidate in clinical development. The success of our product candidate\nwill depend on several factors, including the following:\n\n \n\n \n●\ndesigning,\nconducting and successfully completing preclinical development activities, including preclinical efficacy and IND-enabling studies,\nfor our product candidate or product candidates we may, in the future, in-license or acquire;\n\n \n \n \n\n \n●\ndesigning,\nconducting and completing clinical trials for our product candidate with positive results;\n\n \n \n \n\n \n●\nreceipt\nof regulatory approvals from applicable authorities;\n\n \n \n \n\n \n●\nobtaining\nand maintaining patent and trade secret protection and regulatory exclusivity for our product candidate;\n\n \n \n \n\n \n●\nmaking\narrangements with third-party manufacturers, receiving regulatory approval of our manufacturing processes and our third-party manufacturers’\nfacilities from applicable regulatory authorities and ensuring adequate supply of drug product;\n\n \n \n \n\n \n●\nmanufacturing\nour product candidate at an acceptable cost;\n\n \n \n \n\n \n●\neffectively\nlaunching commercial sales of our product candidate, if approved, whether alone or in collaboration with others;\n\n \n \n \n\n \n●\nachieving\nacceptance of our product candidate, if approved, by patients, the medical community and third-party payors;\n\n \n \n \n\n \n●\neffectively\ncompeting with other therapies;\n\n \n \n \n\n \n●\nif\nour product candidate is approved, obtaining and maintaining coverage and adequate reimbursement by third-party payors, including\ngovernment payors, for our product candidate;\n\n \n \n \n\n \n●\ncomplying\nwith all applicable regulatory requirements, including FDA current Good Clinical Practices (“GCP”), current Good Manufacturing\nPractices (“cGMP”), and standards, rules and regulations governing promotional and other marketing activities;\n\n \n \n \n\n \n●\nmaintaining\na continued acceptable safety profile of the product during development and following approval; and\n\n \n \n \n\n \n●\nmaintaining\nand growing an organization of scientists and business people who can develop and commercialize our product and technology.\n\n \n\nIf\nwe do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to\nsuccessfully develop and commercialize our product candidate, which could materially harm our business.\n\n \n\n26\n\n[Table of Contents](#toc_001)\n\n** **\n\n**We\nmay find it difficult to enroll patients in our clinical trials given the limited number of patients who have the diseases for which\nour product candidate is being studied which could delay or prevent the start of clinical trials for our product candidate.**\n\n \n\nIdentifying\nand qualifying patients to participate in clinical trials of our product candidate is essential to our success. The timing of our clinical\ntrials depends in part on the rate at which we can recruit patients to participate in clinical trials of our product candidate, and we\nmay experience delays in our clinical trials if we encounter difficulties in enrollment. If we experience delays in our clinical trials,\nthe timeline for obtaining regulatory approval of our product candidate will most likely be delayed.\n\n \n\nMany\nfactors may affect our ability to identify, enroll and maintain qualified patients, including the following:\n\n \n\n \n●\neligibility\ncriteria of our ongoing and planned clinical trials with specific characteristics appropriate for inclusion in our clinical trials;\n\n \n \n \n\n \n●\ndesign\nof the clinical trial;\n\n \n \n \n\n \n●\nsize\nand nature of the patient population;\n\n \n \n \n\n \n●\npatients’\nperceptions as to risks and benefits of the product candidate under study and the participation in a clinical trial generally in\nrelation to other available therapies, including any new drugs that may be approved for the indications we are investigating;\n\n \n \n \n\n \n●\nthe\navailability and efficacy of competing therapies and clinical trials;\n\n \n \n \n\n \n●\npendency\nof other trials underway in the same patient population;\n\n \n \n \n\n \n●\nability\nof clinical sites to staff sufficiently for the start-up and conduct of our clinical trial;\n\n \n \n \n\n \n●\nwillingness\nof physicians to participate in our planned clinical trials;\n\n \n \n \n\n \n●\nseverity\nof the disease under investigation;\n\n \n \n \n\n \n●\nproximity\nof patients to clinical sites;\n\n \n \n \n\n \n●\npatients\nwho do not complete the trials for personal reasons; and\n\n \n \n \n\n \n●\nissues\nwith CROs and/or with other vendors that handle our clinical trials.\n\n \n\nWe\nmay not be able to initiate or continue to support clinical trials of our product candidate for one or more indications, or any future\nproduct candidates if we are unable to locate and enroll a sufficient number of eligible participants in these trials as required by\nthe FDA or other regulatory authorities. Even if we are able to enroll a sufficient number of patients in our clinical trials, if the\npace of enrollment is slower than we expect, the development costs for our product candidate may increase and the completion of our trials\nmay be delayed or our trials could become too expensive to complete.\n\n \n\nIf\nwe experience delays in the completion of, or termination of, any clinical trials of our product candidate, the commercial prospects\nof our product candidate could be harmed, and our ability to generate product revenue from any of our product candidate could be delayed\nor prevented. In addition, any delays in completing our clinical trials would likely increase our overall costs, impair product candidate\ndevelopment and jeopardize our ability to obtain regulatory approval relative to our current plans. Any of these occurrences may harm\nour business, financial condition, and prospects significantly.\n\n \n\n**The\nresults of preclinical studies or earlier clinical trials are not necessarily predictive of future results. Our existing product candidate\nin clinical trials, and any other product candidates that may advance into clinical trials, may not have favorable results in later clinical\ntrials or receive regulatory approval.**\n\n \n\nSuccess\nin preclinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate\nthe efficacy and safety of an investigational drug. A number of companies in the pharmaceutical and biotechnology industries, including\nthose with greater resources and experience than us, have suffered significant setbacks in clinical trials, even after seeing promising\nresults in earlier preclinical studies or clinical trials.\n\n \n\nDespite\nthe results reported in earlier preclinical studies or clinical trials for our product candidate, we do not know whether the clinical\ntrials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our product candidate\nfor a particular indication, in any particular jurisdiction. Efficacy data from prospectively designed trials may differ significantly\nfrom those obtained from retrospective subgroup analyses. If later-stage clinical trials do not produce favorable results, our ability\nto achieve regulatory approval for our product candidate may be adversely impacted. Even if we believe that we have adequate data to\nsupport an application for regulatory approval to market our current product candidate or any future product candidates, the FDA or other\nregulatory authorities may not agree and may require that we conduct additional clinical trials.\n\n \n\n27\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Clinical\ndrug development involves a lengthy and expensive process with an uncertain outcome, including the risk of a clinical trial being placed\non clinical hold.**\n\n \n\nClinical\ntesting is expensive and can take many years to complete, with the outcome inherently uncertain. Failure can occur at any time during\nthe clinical trial process. Before obtaining approval from regulatory authorities for the sale of our product candidate, we must conduct\nextensive clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Prior to initiating clinical trials,\na sponsor must complete extensive preclinical testing of a product candidate, including, in most cases, preclinical efficacy experiments\nas well as IND-enabling toxicology studies. These experiments and studies may be time-consuming and expensive to complete. The necessary\npreclinical testing may not be completed successfully for a preclinical product candidate and a potentially promising product candidate\nmay therefore never be tested in humans. Once it commences, clinical testing is expensive, difficult to design and implement, can take\nmany years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The\noutcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results\nof a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying\ninterpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical\nstudies and clinical trials have nonetheless failed to obtain marketing approval of their products. We may experience numerous unforeseen\nevents during drug development that could delay or prevent our ability to receive marketing approval or commercialize our product candidate.\nIn particular, clinical trials of our product candidate may produce inconclusive or negative results. We have limited data regarding\nthe safety, tolerability and efficacy of GP2 administered in combination with GM-CSF. Clinical trials also require the review and oversight\nof an institutional review board (“IRB”). An inability or delay in obtaining IRB approval could prevent or delay the initiation\nand completion of clinical trials, and the FDA may decide not to consider any data or information derived from a clinical investigation\nnot subject to initial and continuing IRB review and approval.\n\n \n\nAs\npreviously disclosed in our Quarterly Report on Form 10-Q for the three months ended March 31, 2022, the FDA placed our evaluation of\nGLSI-100 in certain HER2*/neu* positive patients and Flamingo-01 on clinical hold prohibiting us from commencing Flamingo-01 until\nwe provided such manufacturing information. On July 11, 2022, we received a letter from the FDA stating that we have satisfactorily addressed\nall clinical hold issues identified and that the clinical hold has been removed and we may proceed with the clinical trial. There can\nbe no assurance that the FDA will not place future clinical trials of our product candidate on additional clinical holds in the future.\nClinical trials may be delayed, suspended or prematurely terminated for a variety of reasons, such as:\n\n \n\n \n●\ndelay\nor failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a clinical trial design that we are\nable to execute;\n\n \n \n \n\n \n●\ndelay\nor failure in obtaining authorization to commence a trial or inability to comply with conditions imposed by a regulatory authority\nregarding the scope or design of a clinical trial;\n\n \n \n \n\n \n●\ndelay\nor failure in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject\nto extensive negotiation and may vary significantly among different CROs and trial sites;\n\n \n \n \n\n \n●\ndelay\nor failure in obtaining IRB approval or the approval of other reviewing entities, including comparable foreign regulatory authorities,\nto conduct a clinical trial at each site;\n\n \n \n \n\n \n●\nwithdrawal\nof clinical trial sites from our clinical trials or the ineligibility of a site to participate in our clinical trials;\n\n \n \n \n\n \n●\ndelay\nor failure in recruiting and enrolling suitable patients to participate in a clinical trial;\n\n \n \n \n\n \n●\ndelay\nor failure in patients completing a clinical trial or returning for post-treatment follow-up;\n\n \n \n \n\n \n●\nclinical\nsites and investigators deviating from clinical trial protocol, failing to conduct the clinical trial in accordance with regulatory\nrequirements, or dropping out of a clinical trial;\n\n \n \n \n\n \n●\ninability\nto identify and maintain a sufficient number of clinical trial sites, many of which may already be engaged in other clinical trial\nprograms, including some that may be for the same indication;\n\n \n \n \n\n \n●\nfailure\nof our third-party clinical trial managers, CROs, clinical trial sites, contracted laboratories or other third-party vendors to satisfy\ntheir contractual duties, meet expected deadlines or return trustworthy data;\n\n \n \n \n\n \n●\ndelay\nor failure in adding new clinical trial sites;\n\n \n \n \n\n \n●\ninterim\nresults or data that are ambiguous or negative or are inconsistent with earlier results or data;\n\n \n \n \n\n \n●\nalteration\nof clinical trial design necessitated by re-evaluation of design assumptions based upon observed data;\n\n \n \n \n\n \n●\nfeedback\nfrom the FDA, the IRB or a comparable foreign regulatory authority, or results from earlier stage or concurrent preclinical studies\nand clinical trials, that might require modification to the protocol for a clinical trial;\n\n \n \n \n\n \n●\na\ndecision by the FDA, the IRB, a comparable foreign regulatory authority, or us to suspend or terminate clinical trials at any time\nfor safety issues or for any other reason;\n\n \n \n \n\n \n●\nunacceptable\nrisk-benefit profile, unforeseen safety issues or adverse side effects;\n\n \n \n \n\n \n●\nfailure\nto demonstrate a benefit from using a product candidate;\n\n \n \n \n\n \n●\ndifficulties\nin manufacturing or obtaining from third parties sufficient quantities of a product candidate to start or to use in clinical trials;\n\n \n \n \n\n \n●\nlack\nof adequate funding to continue a clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements\nto conduct additional clinical trials or increased expenses associated with the services of our CROs and other third parties; or\n\n \n \n \n\n \n●\nchanges\nin governmental regulations or administrative actions or lack of adequate funding to continue a clinical trial.\n\n \n\n28\n\n[Table of Contents](#toc_001)\n\n \n\nIf\nwe experience delays in the completion or termination of any clinical trial of our product candidate, the approval and commercial prospects\nof our product candidate will be harmed, delaying our ability to generate product revenues from such product candidate and our costs\nwill most likely increase. The required regulatory approvals may also be delayed, thereby jeopardizing our ability to commence product\nsales and generate revenues and the period of commercial exclusivity for our product may be decreased. Regulatory approval of our product\ncandidate may be denied for the same reasons that caused the delay.\n\n \n\n**Data\nfrom our clinical trials that we announce or publish from time to time may change as more patient data become available either through\nlong-term patient follow-up and/or as such data is audited and verified, which could result in material changes to clinical and safety\nprofiles for our products.**\n\n \n\nFrom\ntime to time, we may disclose data from our preclinical studies and clinical trials. Such data from clinical trials that we may complete\nare subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient\ndata become available or as patients from our clinical trials continue other treatments for their disease. In addition, the clinical\ntrials evaluating our products and product candidates generally require that we continue to monitor and evaluate safety and efficacy\nin patients over an extended period of time following treatment which may result in the safety or efficacy profile to change over time.\nChanges in the efficacy and safety profile of our product or product candidates over time could significantly harm our business prospects\nincluding resulting in volatility in the price of our common stock.\n\n \n\nAdditionally,\nfrom time to time, we may publicly disclose preliminary or top-line data from our preclinical studies and clinical trials, which are\nbased on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following\na more comprehensive review of the data related to the particular study or trial. We 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\nall data. As a result, the top-line or preliminary results that we report may differ from future results of the same studies, or different\nconclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Top-line data also\nremain subject to audit and verification procedures that may result in the final data being materially different from the preliminary\ndata we previously published. As a result, top-line data should be viewed with caution until the final data are available.\n\n \n\nFurther,\nothers, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses\nor may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability\nor commercialization of the particular product candidate or product and our Company in general. In addition, the information we choose\nto publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others\nmay not agree with what we determine is material or otherwise appropriate information to include in our disclosure. If others, including\nregulatory authorities, disagree with the conclusions reached with respect to such information and assessments, our ability to obtain\napproval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or\nfinancial condition.\n\n \n\n**In\nthe clinical trials using GP2, improper intradermal injections or poor HLA binding by GP2 may potentially jeopardize the outcome of the\ntrials.**\n\n \n\nGP2\nis administered intradermally to patients with and without the HLA-A*02 allele. The effectiveness of GP2 is dependent upon attracting\nsufficient antigen presenting cells in the patient’s intradermal space and the association of GP2 with the HLA type of a patient\nto adequately train T cells to kill cancer cells, which may or may not be possible or consistent across all HLA types. It is possible\nthat nurses may not successfully inject GP2 in the intradermal space or that certain HLA types may form weak or no association with GP2,\npotentially leading to weak or no immune response to GP2 and thus no benefit to patients with some or any HLA type.\n\n \n\n29\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Risks\nassociated with out-licensing GP2 or future product candidates in foreign countries could materially adversely affect the commercialization\nof our products.**\n\n \n\nWe\nmay not be able to market products abroad if we cannot complete out-licensing transactions of GP2 or future product candidates by signing\nlicensing agreements with regional companies in countries where we plan to commercialize our products but where we do not have any operations.\nRisks associated with out-licensing transactions of our products in foreign countries include:\n\n \n\n \n●\nfailure\nto obtain regulatory approval or intellectual property rights in any country which could lead to the termination of a licensing transaction\nin that country;\n\n \n \n \n\n \n●\nthe\ninability to obtain the issuance of patent claims or regulatory status in a foreign country that provide periods of market exclusivity\nor data exclusivity prior to the entry of generic or biosimilar forms of our products;\n\n \n \n \n\n \n●\nthe\ndifficulty of pursuing legal remedies to disputes or to secure monetary damages in foreign countries;\n\n \n \n \n\n \n●\nthe\ninability to repatriate income from a licensing transaction in a foreign country to the U.S. or to other foreign countries where\ncash is needed; and\n\n \n \n \n\n \n●\nThe\npotential to not realize or to delay development or commercialization milestone payments due to unanticipated outcomes that prevent\nor delay the milestone.\n\n \n\n**Risks\nassociated with operating in foreign countries could materially adversely affect our product development.**\n\n \n\nWe\nmay conduct future clinical trials in countries outside of the U.S. Consequently, we may be subject to risks related to operating in\nforeign countries. Risks associated with conducting operations in foreign countries include:\n\n \n\n \n●\ndiffering\nregulatory requirements for drug approvals and regulation of approved drugs in foreign countries; more stringent privacy requirements\nfor data to be supplied to our operations in the U.S., *e.g.*, General Data Protection Regulation in the European Union;\n\n \n \n \n\n \n●\nunexpected\nchanges in tariffs, trade barriers and regulatory requirements; economic weakness, including inflation, or political instability\nin particular foreign economies and markets; compliance with tax, employment, immigration and labor laws for employees living or\ntraveling abroad; foreign taxes, including withholding of payroll taxes;\n\n \n \n \n\n \n●\ndiffering\npayor reimbursement regimes, governmental payors or patient self-pay systems and price controls;\n\n \n \n \n\n \n●\nforeign\ncurrency fluctuations, which could result in increased operating expenses or reduced revenues, and other obligations incident to\ndoing business or operating in another country;\n\n \n \n \n\n \n●\nworkforce\nuncertainty in countries where labor unrest is more common than in the U.S.;\n\n \n \n \n\n \n●\nproduction\nshortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and\n\n \n \n \n\n \n●\nbusiness\ninterruptions resulting from geopolitical actions, including war and terrorism.\n\n \n\n**Our\ncurrent and future product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or\nhave other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result\nin significant negative consequences following any regulatory approval.**\n\n \n\nUndesirable\nside effects caused by our current or future product candidates, their delivery methods or dosage levels could cause us or regulatory\nauthorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory\napproval or termination of clinical trials by the FDA or other comparable foreign regulatory authorities; or an IRB, that approves and,\nmonitors biomedical research to protect the rights and welfare of human patients. As a result of safety or toxicity issues that we may\nexperience in our clinical trials, or negative or inconclusive results from the clinical trials of others for drug candidates similar\nto our own, we may not receive approval to market our current product candidate or any product candidates we may pursue, which could\nprevent us from ever generating revenues or achieving profitability. Results of our trials could reveal an unacceptably high severity\nand incidence of side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory\nauthorities could order us to cease further development of or deny approval of our current or any future product candidates for any or\nall targeted indications. The drug-related side effects could also affect patient recruitment or the ability of enrolled patients to\ncomplete the trial or result in potential product liability claims. Any of these occurrences may have a material adverse effect on our\nbusiness, results of operations, financial condition, cash flows and future prospects.\n\n \n\nAdditionally,\nif our product candidate receives regulatory approval, and we or others later identify undesirable side effects caused by such product,\na number of potentially significant negative consequences could result, including that:\n\n \n\n \n●\nwe\nmay be forced to suspend marketing of such product;\n\n \n \n \n\n \n●\nregulatory\nauthorities may withdraw their approvals of such product;\n\n \n \n \n\n \n●\nregulatory\nauthorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success\nof such product;\n\n \n \n \n\n \n●\nwe\nmay be required to conduct post-marketing clinical trials;\n\n \n \n \n\n \n●\nwe\nmay be required to change the way the product is administered;\n\n \n \n \n\n \n●\nwe\ncould be sued and held liable for harm caused to patients; and\n\n \n \n \n\n \n●\nour\nreputation may suffer.\n\n \n\nAny\nof these events could prevent us from achieving or maintaining market acceptance of our product candidate, if approved.\n\n \n\n30\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Our\nproduct development program may not uncover all possible adverse events that patients who take our product candidate may experience.\nThe number of patients exposed to our product candidate and the average exposure time in the clinical development program may be inadequate\nto detect rare adverse events or chance findings that may only be detected once the product is administered to more patients and for\ngreater periods of time.**\n\n \n\nClinical\ntrials by their nature utilize a sample of the potential patient population. However, with a limited number of patients and limited duration\nof exposure, we cannot be fully assured that rare and severe side effects of our product candidate will be uncovered. Such rare and severe\nside effects may only be uncovered with a significantly larger number of patients exposed to our product candidate. If such safety problems\noccur or are identified after our product candidate reaches the market, the FDA may require that we amend the labeling of the product\nor recall the product, or may even withdraw approval for the product.\n\n \n\n**Failure\nto successfully validate and develop a companion diagnostic for our product candidate could harm our drug development strategy and operational\nresults.**\n\n \n\nOur\nproduct development program is dependent on the validation and development of an in vitro companion diagnostic by us or by third-party\ncollaborators. Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to\nregulation as medical devices. The approval of a companion diagnostic as part of the product labeling may limit the use of the product\ncandidate to only those patients who express the specific genetic alteration it was developed to detect.\n\n \n\nCompanion\ndiagnostics are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and require separate\nclearance or approval prior to their commercialization. To date, the FDA has required premarket approval of all companion diagnostics\nfor cancer therapies, either at the time of initial drug approval, or as a post-marketing commitment. We, and our third-party collaborators,\nmay encounter difficulties in developing and obtaining approval for these companion diagnostics. Our third-party collaborators may de-prioritize,\nabandon or fail to execute against our development projects. Any delay or failure by us or third-party collaborators to develop or obtain\nregulatory approval of a companion diagnostic could delay or prevent approval of our related product candidates.\n\n \n\n**Our\nfuture success is dependent on the regulatory approval of our product candidate.**\n\n \n\nOur\nbusiness is dependent on our ability to obtain regulatory approval for our product candidate in a timely manner. We cannot commercialize\nour product candidate in the U.S. without first obtaining regulatory approval for the product from the FDA. Similarly, we cannot commercialize\nour product candidate outside of the U.S. without obtaining regulatory approval from comparable foreign regulatory authorities. Before\nobtaining regulatory approvals for the commercial sale of our product candidate for a target indication, we must demonstrate with substantial\nevidence gathered in preclinical studies and clinical trials, that the product candidate is safe and effective for use for that target\nindication and that the manufacturing facilities, processes and controls are adequate with respect to such product candidate.\n\n \n\nThe\ntime required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years\nfollowing the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion\nof the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain\napproval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.\n\n \n\nEven\nif a product candidate were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval\nmight contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications,\nor may be subject to burdensome post-approval clinical trial or risk management requirements. Also, any regulatory approval of our current\nproduct candidate or any future product candidates we may pursue, once obtained, may be withdrawn.\n\n \n\n**Our\ncurrent product candidate and future product candidates could fail to receive regulatory approval from the FDA.**\n\n \n\nWe\nhave not obtained regulatory approval for our product candidate and it is possible that our existing product candidate or any future\nproduct candidates will not obtain regulatory approval, for many reasons, including:\n\n \n\n \n●\ndisagreement\nwith the regulatory authorities regarding the scope, design or implementation of our clinical trials;\n\n \n \n \n\n \n●\nfailure\nto demonstrate that a product candidate is safe and effective for our proposed indication;\n\n \n \n \n\n \n●\nfailure\nof clinical trials to meet the level of statistical significance required for approval;\n\n \n \n \n\n \n●\nfailure\nto demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;\n\n \n \n \n\n \n●\ndisagreement\nwith our interpretation of data from preclinical studies or clinical trials;\n\n \n \n \n\n \n●\nthe\ninsufficiency of data collected from clinical trials of our product candidate to support the submission and filing of a BLA, NDA\nor other submission or to obtain regulatory approval;\n\n \n \n \n\n \n●\nfailure\nto obtain approval of our manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and\ncommercial supplies or our own manufacturing facility; or\n\n \n \n \n\n \n●\nchanges\nin the approval policies or regulations that render our preclinical and clinical data insufficient for approval.\n\n \n\nThe\nFDA or a comparable foreign regulatory authority may require more information, including additional preclinical or clinical data to support\napproval or additional clinical trials, which may delay or prevent approval and our commercialization plans, or we may decide to abandon\nthe development program. If we were to obtain approval, regulatory authorities may approve our current product candidate and any future\nproduct candidates we may pursue for fewer or more limited indications than we request (including failing to approve the most commercially\npromising indications), may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product\ncandidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that\nproduct candidate.\n\n \n\nIf\nwe are unable to obtain regulatory approval for our product candidate in one or more jurisdictions, or any approval contains significant\nlimitations, we may not be able to obtain sufficient funding to continue the development of that product or generate revenues attributable\nto that product candidate.\n\n \n\n31\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Failure\nto obtain regulatory approval in international jurisdictions would prevent our product candidate from being marketed abroad.**\n\n \n\nIn\naddition to regulations in the U.S., to market and sell our product candidate in the European Union, United Kingdom, many Asian countries\nand other jurisdictions, we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. Approval\nby the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority\noutside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. The regulatory\napproval process outside the U.S. generally includes all of the risks associated with obtaining FDA approval as well as risks attributable\nto the satisfaction of local regulations in foreign jurisdictions. The approval procedure varies among countries and can involve additional\ntesting. The time required to obtain approval may differ substantially from that required to obtain FDA approval. We may not be able\nto obtain approvals from regulatory authorities outside the U.S. on a timely basis, if at all. Clinical trials accepted in one country\nmay not be accepted by regulatory authorities in other countries. In addition, many countries outside the U.S. require that a product\nbe approved for reimbursement before it can be approved for sale in that country. A product candidate that has been approved for sale\nin a particular country may not receive reimbursement approval in that country.\n\n \n\nWe\nmay not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our product in any market.\nIf we are unable to obtain approval of any of our current product candidate or any future product candidates we may pursue by regulatory\nauthorities in the European Union, United Kingdom, Asia or elsewhere, the commercial prospects of that product candidate may be significantly\ndiminished, our business prospects could decline and this could materially adversely affect our business, results of operations and financial\ncondition.\n\n \n\n**Even\nif our current candidate receives regulatory approval, it may still face future development and regulatory difficulties.**\n\n \n\nEven\nif we obtain regulatory approval for our product candidate, that approval would be subject to ongoing requirements by the FDA and comparable\nforeign regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage, distribution,\nadverse event reporting, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other\npost-marketing information. These requirements include submissions of safety and other post-marketing information and reports, registration,\nas well as continued compliance by us and/or our CMOs and CROs for any post-approval clinical trials that we may conduct. The safety\nprofile of any product will continue to be closely monitored by the FDA and comparable foreign regulatory authorities after approval.\nIf the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of our product candidate,\nthey may require labeling changes or establishment of a risk evaluation and mitigation strategy, impose significant restrictions on such\nproduct’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval clinical trials or post-market\nsurveillance.\n\n \n\nIn\naddition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and\nother regulatory authorities for compliance with cGMP, GCP, and other regulations. If we or a regulatory agency discover previously unknown\nproblems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product\nis manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall\nor withdrawal of the product from the market or suspension of manufacturing. If we, our product candidate or the manufacturing facilities\nfor our product candidate fail to comply with applicable regulatory requirements, a regulatory agency may:\n\n \n\n \n●\nissue\nwarning letters or untitled letters;\n\n \n \n \n\n \n●\nmandate\nmodifications to promotional materials or require us to provide corrective information to healthcare practitioners;\n\n \n \n \n\n \n●\nrequire\nus to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due\ndates for specific actions and penalties for noncompliance;\n\n \n \n \n\n \n●\nseek\nan injunction or impose civil or criminal penalties or monetary fines;\n\n \n \n \n\n \n●\nsuspend\nor withdraw regulatory approval;\n\n \n \n \n\n \n●\nsuspend\nany ongoing clinical trials;\n\n \n \n \n\n \n●\nrefuse\nto approve pending applications or supplements to applications filed by us;\n\n \n \n \n\n \n●\nsuspend\nor impose restrictions on operations, including costly new manufacturing requirements; or\n\n \n \n \n\n \n●\nseize\nor detain products, refuse to permit the import or export of products, or require us to initiate a product recall.\n\n \n\nThe\noccurrence of any event or penalty described above may inhibit our ability to successfully commercialize our product and generate revenues.\n\n \n\nAdvertising\nand promotion of any product candidate that obtains approval in the U.S. is heavily scrutinized by the FDA, the Department of Justice,\nthe Office of Inspector General of Health and Human Services, state attorneys general, members of Congress and the public. A company\ncan make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the\nprovisions of the approved label. Additionally, advertising and promotion of any product candidate that obtains approval outside of the\nU.S. is heavily scrutinized by comparable foreign regulatory authorities. Violations, including actual or alleged promotion of our product\nfor unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions\nby the FDA, as well as prosecution under the federal False Claims Act. Any actual or alleged failure to comply with labeling and promotion\nrequirements may have a negative impact on our business.\n\n \n\n32\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Risks\nRelated to Our Manufacturing**\n\n \n\n**We\nhave limited to no manufacturing, sales, marketing or distribution capability and must rely upon third parties for such.**\n\n \n\nWe\ncurrently have purchase orders with various third-party manufacturing facilities for production of our product candidate for research\nand development and testing purposes. We depend on these manufacturers to meet our deadlines, quality standards and specifications. Our\nreliance on third parties for the manufacture of our active pharmaceutical ingredient and drug product and, in the future, any approved\nproducts, creates a dependency that could severely disrupt our research and development, our clinical testing, and ultimately our sales\nand marketing efforts if the source of such supply proves to be unreliable or unavailable. If the contracted manufacturing source is\nunreliable or unavailable, we may not be able to manufacture clinical drug supplies of our product candidate, and our preclinical and\nclinical testing programs may not be able to move forward and our entire business plan could fail.\n\n \n\nThe\nactive pharmaceutical ingredient for our product candidate is currently sourced from Polypeptide Laboratories located in San Diego, California.\nWe believe this single source is currently capable of supplying all anticipated needs of our proposed clinical trials, as well as initial\ncommercial introduction. We will be developing a source or sources for drug product manufacturing. If we are able to commercialize our\nproduct in the future, there is no assurance that our manufacturers will be able to meet commercialized scale production requirements\nin a timely manner or in accordance with applicable standards or cGMP. Once the nature and scope of additional indications and their\ncommensurate drug product demands are established, we will seek secondary suppliers of both the active pharmaceutical ingredient and\ndrug product for our product candidate, but we cannot assure that such secondary suppliers will be found on terms acceptable to us, or\nat all.\n\n \n\n**We\nare subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product\ncandidate.**\n\n \n\nWe\nand our CMOs will need to conduct significant development work for our product candidate for each target indication for studies, clinical\ntrials and commercial launch readiness. Developing commercially viable manufacturing processes is a difficult, expensive and uncertain\ntask, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including\ncost overruns, potential problems with process scale-up, process reproducibility, stability issues, consistency and timely availability\nof reagents or raw materials. The manufacturing facilities in which our product candidate will be made could be adversely affected by\nearthquakes and other natural disasters, medical pandemics, equipment failures, labor shortages, power failures, and numerous other factors.\n\n \n\nAdditionally,\nthe process of manufacturing our product candidate is complex, highly regulated and subject to several risks, including but not limited\nto:\n\n \n\n \n●\nproduct\nloss due to contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error;\n\n \n \n \n\n \n●\nreduced\nproduction yields, product defects, and other supply disruptions due to deviations, even minor, from normal manufacturing and distribution\nprocesses;\n\n \n \n \n\n \n●\nunexpected\nproduct defects; and\n\n \n \n \n\n \n●\nmicrobial,\nviral, or other contaminations in our product candidate or in the manufacturing facilities in which our product candidate is made,\nwhich may result in the closure of such manufacturing facilities for an extended period of time to allow for the investigation and\nremediation of the contamination.\n\n \n\nAny\nadverse developments affecting manufacturing operations for our product candidate may result in shipment delays, inventory shortages,\nlot failures, withdrawals or recalls or other interruptions in the supply of our drug substance and drug product, which could delay the\ndevelopment of our product candidate. We may also have to write off inventory, incur other charges and expenses for supply of drug product\nthat fails to meet specifications, undertake costly remediation efforts, or seek more costly manufacturing alternatives. Inability to\nmeet the demand for our product candidate could damage our reputation and the reputation of our product among physicians, healthcare\npayors, patients or the medical community, and cancer treatment centers, which could adversely affect our ability to operate our business\nand our results of operations.\n\n \n\n**In\nthe clinical trials using GP2, GM-CSF is also administered and its availability is dependent upon a third-party manufacturer, which may\nor may not reliably provide GM-CSF, thus jeopardizing the completion of the trials.**\n\n \n\nGP2\nis administered in combination with GM-CSF which is available in both liquid and lyophilized forms exclusively from one manufacturer.\nWe will continue to be dependent on such manufacturer for our supply of GM-CSF in combination with GP2 in the ongoing GP2 trials and\nupon the potential commercialization of GP2. We have not entered into a supply agreement with the manufacturer for GM-CSF, and instead\nrely on purchase orders to meet our supply needs. Any temporary interruptions or discontinuation of the availability of GM-CSF could\nhave a material adverse effect on our operations.\n\n \n\n33\n\n[Table of Contents](#toc_001)\n\n \n\n**If\nany of our CMOs’ clinical manufacturing facilities are damaged or destroyed or production at such facilities is otherwise interrupted,\nour business and prospects would be negatively affected.**\n\n \n\nIf\nour CMOs’ manufacturing facilities or the equipment in them is damaged or destroyed, we may not be able to quickly or inexpensively\nreplace our manufacturing capacity or replace it at all. In the event of a temporary or protracted loss of this facility or equipment,\nwe might not be able to transfer manufacturing to another CMO. Even if we could transfer manufacturing to another CMO, the shift would\nlikely be expensive and time-consuming, particularly because the new facility would need to comply with the necessary regulatory requirements\nand we would need FDA approval before selling any products manufactured at that facility. Such an event could delay our clinical trials\nor reduce our product sales.\n\n \n\nAlthough\nwe do not currently maintain insurance coverage against damage to our property and to cover business interruption and research and development\nrestoration expenses, any insurance coverage we obtain in the future may not reimburse us, or may not be sufficient to reimburse us,\nfor any expenses or losses we may suffer. We may be unable to meet our requirements for our product candidate if there were a catastrophic\nevent or failure of our current manufacturing facility or processes.\n\n \n\n**Risks\nRelated to Our Dependence on Third Parties and Our License Agreements**\n\n \n\n**We\nrely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their\ncontractual duties or meet expected deadlines, or if we lose any of our CROs or other key third-party vendors, we may not be able to\nobtain regulatory approval for or commercialize our current or future product candidates on a timely basis, if at all.**\n\n \n\nOur\ninternal capacity for clinical trial execution and management is limited and therefore we rely heavily on third parties. We have relied\nupon and plan to continue to rely upon third-party CROs, vendors and contractors to monitor and manage data for our ongoing preclinical\nand clinical programs. For example, our collaborating investigators along with their clinical and clinical operations teams may manage\nthe conduct of any future clinical trials for GP2 as well as perform the analysis, publication and presentation of data and results related\nto this program.\n\n \n\nWe\nplan to rely on CROs and other third-party vendors for all currently contemplated clinical trials. We rely on these parties for the execution\nof our preclinical studies and clinical trials, including the proper and timely conduct of our clinical trials, and we control only some\naspects of their activities. Outsourcing these functions involves risk that third parties may not perform to our standards, may not produce\nresults or data in a timely manner or may fail to perform at all.\n\n \n\nWhile\nwe may have agreements governing the commitments of our third-party vendor services, we will have limited influence over their actual\nperformance. Nevertheless, we will be responsible for ensuring that each of our trials is conducted in accordance with the applicable\nprotocol and legal, regulatory and scientific standards, and our reliance on the CROs will not relieve us of our regulatory responsibilities.\n\n \n\nIf\nour Company, or any of our partners or CROs, fail to comply with applicable regulations and good clinical practices, the clinical data\ngenerated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to\nperform additional clinical trials before approving our regulatory applications. We cannot assure you that upon inspection by a given\nregulatory authority, such regulatory authority will determine that any of our clinical trials comply with applicable requirements. In\naddition, our clinical trials must be conducted with product produced under cGMP and other requirements. We are also required to register\nongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, *clinicaltrials.gov*,\nwithin a specified timeframe. Failure to comply also would violate federal requirements in the U.S. and could result in other penalties,\nwhich would delay the regulatory approval process and result in adverse publicity.\n\n \n\n34\n\n[Table of Contents](#toc_001)\n\n \n\nOur\nCROs, third-party vendors and contractors are not and will not be our employees, and except for remedies available to us under our agreements\nwith such CROs, third-party vendors and contractors, we cannot control whether or not they devote sufficient time and resources, including\nexperienced staff, to our ongoing clinical, nonclinical and preclinical programs. They may also have relationships with other entities,\nsome of which may be our competitors. If CROs, third-party vendors and contractors do not successfully carry out their contractual duties\nor obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is compromised due to the failure\nto adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated\nand we may not be able to obtain regulatory approval for or successfully commercialize our current or future product candidates. CRO,\nvendor or contractor errors could cause our results of operations and the commercial prospects for our current or future product candidates\nto be harmed, our costs to increase and our ability to generate revenues to be delayed.\n\n \n\nIn\naddition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could\nincrease the risk that this information will be misappropriated. To the extent we are unable to identify and successfully manage the\nperformance of third-party service providers in the future, our business may be adversely affected. Though, once engaged, we intend to\ncarefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future\nor that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.\n\n \n\n**We\nare dependent on technologies we license, and if we lose the right to license such technologies or we fail to license new technologies\nin the future, our ability to develop new products would be harmed, and if we fail to meet our obligations under our license agreements,\nwe may lose the ability to develop our product candidate.**\n\n \n\nWe\ncurrently are dependent on a license from HJF for technologies relating to our product candidate. The license imposes, and any future\nlicenses we enter into are likely to impose, various development, funding, royalty, diligence, sublicensing, insurance and other obligations\non us. If our license with respect to any of these technologies is terminated for any reason, the development of the products contemplated\nby the licenses would be delayed, or suspended altogether, while we seek to license similar technology or develop new non-infringing\ntechnology which could have a material adverse effect on our business.\n\n \n\n**Our\noperations or those of the third parties upon whom we depend might be affected by the occurrence of a natural disaster, pandemic, war\nor other catastrophic event.**\n\n \n\nWe\ndepend on our employees, consultants, CMOs, CROs, as well as regulatory agencies and other parties, for the continued operation of our\nbusiness. Despite any precautions we take for natural disasters or other catastrophic events, these events, including terrorist attacks,\npandemics, hurricanes, fires, floods and ice and snowstorms, could result in significant disruptions to our research and development,\npreclinical studies, clinical trials, and, ultimately, commercialization of our products. Long-term disruptions in the infrastructure\ncaused by events, such as natural disasters, the outbreak of war (including expansion of the current armed conflict between Russia and\nUkraine), the escalation of hostilities and acts of terrorism or other “acts of God,” particularly involving cities in which\nwe have offices, manufacturing or clinical trial sites, could adversely affect our businesses. Although we carry business interruption\ninsurance policies and typically have provisions in our contracts that protect us in certain events, our coverage might not include or\nbe adequate to compensate us for all losses that may occur. Any natural disaster or catastrophic event affecting us, our CMOs, our CROs,\nregulatory agencies or other parties with which we are engaged could have a material adverse effect on our operations and financial performance.\n\n \n\n35\n\n[Table of Contents](#toc_001)\n\n \n\n**We\nmay not realize the benefits of our strategic alliances that we may form in the future.**\n\n \n\nWe\nmay form strategic alliances, create joint ventures or collaborations or enter into licensing arrangements with third parties that we\nbelieve will complement or augment our existing business. These relationships, or those like them, may require us to incur nonrecurring\nand other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our\nmanagement and business. In addition, we face significant competition in seeking appropriate strategic alliances and the negotiation\nprocess is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic alliance or other alternative\narrangements for or current product candidate or any future product candidates and programs because our research and development pipeline\nmay be insufficient, our current product candidate and future product candidates and programs may be deemed to be at too early a stage\nof development for collaborative effort and third parties may not view such product candidates and programs as having the requisite potential\nto demonstrate safety and efficacy. If we license products or acquire businesses, we may not be able to realize the benefit of such transactions\nif we are unable to successfully integrate them with our existing operations and company culture. We cannot be certain that, following\na strategic transaction or license, we will achieve the revenues or specific net income that justifies such transaction. Any delays in\nentering into new strategic alliances agreements related to our current product candidate or future product candidates could also delay\nthe development and commercialization of such product candidates and reduce their competitiveness even if they reach the market.\n\n \n\n**Our\nbusiness involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental,\nhealth and safety laws and regulations, which can be expensive and restrict how we do business.**\n\n \n\nOur\nthird-party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials.\nWe and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal\nof these hazardous materials even after we sell or otherwise dispose of the products. In some cases, these hazardous materials and various\nwastes resulting from their use will be stored at our contractors or manufacturers’ facilities pending use and disposal. We cannot\ncompletely eliminate the risk of contamination, which could cause injury to our employees and others, environmental damage resulting\nin costly cleanup and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials\nand specified waste products. Although we expect that the safety procedures utilized by our third-party contractors and manufacturers\nfor handling and disposing of these materials will generally comply with the standards prescribed by these laws and regulations, we cannot\nguarantee that this will be the case or eliminate the risk of accidental contamination or injury from these materials. In such an event,\nwe may be held liable for any resulting damages and such liability could exceed our resources. We do not currently carry biological or\nhazardous waste insurance coverage and any future property and casualty, and general liability insurance policies may exclude coverage\nfor damages and fines arising from biological or hazardous waste exposure or contamination.\n\n \n\n**We\nmay not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize our\nproduct candidate.**\n\n \n\nWe\nexpect to depend on collaborators, partners, licensees, CROs and other third parties to formulate our product candidate, to manufacture\nour product candidate, and to conduct clinical trials for our product candidate. We cannot guarantee that we will be able to successfully\nnegotiate agreements for or maintain relationships with collaborators, partners, licensees, clinical investigators, vendors and other\nthird parties on favorable terms, if at all. Our ability to successfully negotiate such agreements will depend on, among other things,\npotential partners’ evaluation of the superiority of our technology over competing technologies and the quality of the preclinical\nand clinical data that we have generated, and the perceived risks specific to developing our product candidate. If we are unable to obtain\nor maintain these agreements, we may not be able to clinically develop, formulate, manufacture, obtain regulatory approvals for or commercialize\nour product candidate. We cannot necessarily control the amount or timing of resources that our contract partners will devote to our\nproduct candidate, and we cannot guarantee that these parties will fulfill their obligations to us under these arrangements in a timely\nfashion. We may not be able to readily terminate any such agreements with contract partners even if such contract partners do not fulfill\ntheir obligations to us.\n\n \n\nIn\naddition, we may receive notices from third parties from time to time alleging that our technology or product candidate infringes upon\nthe intellectual property rights of those third parties. Any assertion by third parties that our activities or product candidate infringes\nupon the intellectual property rights of third parties may adversely affect our ability to secure strategic partners or licensees for\nour technology or product candidate or our ability to secure or maintain manufacturers for our compounds.\n\n \n\n**Risks\nRelated to Our Intellectual Property**\n\n \n\n**We\nrely on an exclusive license granted to us by HJF with respect to GP2, and if HJF does not adequately defend such license, our business\nmay be harmed.**\n\n \n\nWe\nhave been granted an exclusive license to GP2, our product candidate, from HJF. The GP2 patent rights were assigned to HJF by certain\nthird parties including the Uniformed Services University of the Health Sciences. We rely on HJF to maintain the patents already issued\nwith respect to GP2, to continue to pursue patent applications pending in certain countries with respect to GP2, and otherwise protect\nthe intellectual property covered by our exclusive license agreement. We have limited control over the activities of HJF or over any\nother intellectual property that may be related to GP2. For example, we cannot be certain that activities by HJF have been or will be\nconducted in compliance with applicable laws and regulations and/or any agreements between HJF and the third party assignors. We have\nno control or input over whether, and in what manner, HJF may enforce or defend the patents against a third-party. HJF may enforce or\ndefend the patent less vigorously than if we had enforced or defended the patents ourselves. Further, HJF may not necessarily seek enforcement\nin scenarios in which we would feel that enforcement was in our best interests. For example, HJF may not enforce the patents against\na competitor of ours who is not a direct competitor of HJF. If our in-licensed intellectual property is found to be invalid or unenforceable,\nthen HJF may not be able to enforce the patents against a competitor of ours. If we fail to meet our obligations under our exclusive\nlicense agreement with HJF, then HJF may terminate such agreement. Although we may choose to terminate our license agreement with HJF,\ndoing so would allow a third party to seek and obtain an exclusive license to GP2. If a third party obtains an exclusive license to intellectual\nproperty with respect to GP2, then the third party may seek to enforce the intellectual property against us which may have a material\nadverse effect on our business.\n\n \n\n36\n\n[Table of Contents](#toc_001)\n\n \n\n**It\nis difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position\ndoes not adequately protect our product candidate, others could compete against us more directly, which would harm our business, possibly\nmaterially.**\n\n \n\nOur\ncommercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current product\ncandidate and future product candidates, the processes used to manufacture them and the methods for using them, as well as successfully\ndefending these patents against third-party challenges. As of the date of this Annual Report on Form 10-K, we only have licensed rights\nfrom HJF to certain issued patents as well as patent applications which are currently pending in certain countries with respect to GP2.\nOur ability to stop third parties from making, using, selling, offering to sell or importing our product candidate is dependent upon\nthe extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities.\n\n \n\nThe\npatent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions\nfor which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in pharmaceutical\npatents has emerged to date in the U.S. or in foreign jurisdictions outside of the U.S. Changes in either the patent laws or interpretations\nof patent laws in the U.S. and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the\nbreadth of claims that may be enforced in the patents that may be issued from the applications we currently or may in the future own\nor license from third parties. Further, if any patents we obtain or license are deemed invalid and unenforceable, our ability to commercialize\nor license our technology could be adversely affected.\n\n \n\nOthers\nhave filed, and in the future are likely to file, patent applications covering products and technologies that are similar, identical\nor competitive to ours or important to our business. We cannot be certain that any patent application owned by a third party will not\nhave priority over patent applications filed or in-licensed by us, or that we or our licensors will not be involved in interference,\nopposition, reexamination, review, reissue, post grant review or invalidity proceedings before U.S. or non-U.S. patent offices.\n\n \n\nThe\ndegree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately\nprotect our rights or permit us to gain or keep our competitive advantage. For example:\n\n \n\n \n●\nothers\nmay be able to make compounds that are similar to our product candidate, but that are not covered by the claims of our licensed patents;\n\n \n \n \n\n \n●\nHJF\nmight not have been the first to make the inventions covered by its pending patent applications;\n\n \n \n \n\n \n●\nwe\nor HJF might not have been the first to file patent applications for these inventions;\n\n \n \n \n\n \n●\nHJF’s\npending patent applications may not result in issued patents;\n\n \n \n \n\n \n●\nthe\nclaims of HJF’s issued patents or patent applications when issued may not cover our product or product candidate;\n\n \n \n \n\n \n●\nany\npatents that we obtain from licensing or otherwise may not provide us with any competitive advantages;\n\n \n \n \n\n \n●\nany\ngranted patents that we rely upon may be held invalid or unenforceable as a result of legal challenges by third parties; and\n\n \n \n \n\n \n●\nthe\npatents of others may have an adverse effect on our business.\n\n \n\n**If\nwe fail to comply with our obligations in the agreements under which we may license intellectual property rights from third parties or\notherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business.**\n\n \n\nWe\nmay be required to enter into intellectual property license agreements that are important to our business. These license agreements may\nimpose various diligence, milestone payment, royalty and other obligations on us. For example, we may enter into exclusive license agreements\nwith various universities and research institutions, we may be required to use commercially reasonable efforts to engage in various development\nand commercialization activities with respect to licensed products, and may need to satisfy specified milestone and royalty payment obligations.\nIf we fail to comply with any obligations under our agreements with any of these licensors, we may be subject to termination of the license\nagreement in whole or in part; increased financial obligations to our licensors or loss of exclusivity in a particular field or territory,\nin which case our ability to develop or commercialize products covered by the license agreement will be impaired.\n\n \n\nIn\naddition, disputes may arise regarding intellectual property subject to a license agreement, including:\n\n \n\n \n●\nthe\nscope of rights granted under the license agreement and other interpretation-related issues;\n\n \n \n \n\n \n●\nthe\nextent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing\nagreement;\n\n \n\n37\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\nour\ndiligence obligations under the license agreement and what activities satisfy those obligations;\n\n \n \n \n\n \n●\nif\na third-party expresses interest in an area under a license that we are not pursuing, under the terms of certain of our license agreements,\nwe may be required to sublicense rights in that area to a third party, and that sublicense could harm our business; and\n\n \n \n \n\n \n●\nthe\nownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us.\n\n \n\nIf\ndisputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements\non acceptable terms, we may be unable to successfully develop and commercialize our product candidate.\n\n \n\nWe\nmay need to obtain licenses from third parties to advance our research or allow commercialization of our product candidate. We may fail\nto obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further\ndevelop and commercialize our product candidate, which could harm our business significantly.\n\n \n\n**We\nmay incur substantial costs as a result of litigation or other proceedings relating to patents and other intellectual property rights.**\n\n \n\nIf\nwe choose to commence a proceeding or litigation to prevent another party from infringing HJF’s patents, that party will have the\nright to ask the examiner or court to rule that such patents are invalid or should not be enforced against them. There is a risk that\nthe examiner or court will decide that HJF’s patents are not valid and that HJF does not have the right to stop the other party\nfrom using the related inventions. There is also the risk that, even if the validity of such patents is upheld, the examiner or court\nwill refuse to stop the other party on the ground that such other party’s activities do not infringe our rights to such patents.\nIn addition, the U.S. Supreme Court has recently modified some tests used by the U.S. Patent and Trademark Office (the “USPTO”)\nin granting patents over the past 20 years, which may decrease the likelihood that we or HJF will be able to obtain patents and increase\nthe likelihood of challenge to any patents we obtain or license. Any proceedings or litigation to enforce our intellectual property rights\nor defend ourselves against claims of infringement of third-party intellectual property rights could be costly and divert the attention\nof managerial and scientific personnel, regardless of whether such litigation is ultimately resolved in our favor. We may not have sufficient\nresources to bring these actions to a successful conclusion. Moreover, if we are unable to successfully defend against claims that we\nhave infringed the intellectual property rights of others, we may be prevented from using certain intellectual property and may be liable\nfor damages, which in turn could materially adversely affect our business, financial condition or results of operations.\n\n \n\n**We\nmay infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from\ncommercializing or increase the costs of commercializing our product candidate.**\n\n \n\nOur\nsuccess will depend in part on our ability to operate without infringing the proprietary rights of third parties. We cannot guarantee\nthat our product candidate, or manufacture or use of our product candidate, will not infringe third-party patents. Furthermore, a third\nparty may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging\nin our normal operations and activities, including making or selling our product candidate. These lawsuits are costly and could affect\nour results of operations and divert the attention of managerial and scientific personnel. Some of these third parties may be better\ncapitalized and have more resources than us. There is a risk that a court would decide that we are infringing the third party’s\npatents and would order us to stop the activities covered by the patents. In that event, we may not have a viable way around the patent\nand may need to halt commercialization of our product candidate. In addition, there is a risk that a court will order us to pay the other\nparty damages for having violated the other party’s patents. In addition, we may be obligated to indemnify our licensors and collaborators\nagainst certain intellectual property infringement claims brought by third parties, which could require us to expend additional resources.\nThe pharmaceutical and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants,\nincluding us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by\nthe courts, and the interpretation is not always uniform.\n\n \n\nIf\nwe are sued for patent infringement, we would need to demonstrate that our product candidate or methods either do not infringe the patent\nclaims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. Proving invalidity is difficult.\nFor example, in the U.S., proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity\nenjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and divert management’s\ntime and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing\nthe patent rights of others, we may be required to seek a license, which may not be available, defend an infringement action or challenge\nthe validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these\nactions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to\ndefend an infringement action successfully or have infringed patents declared invalid, we may incur substantial monetary damages, encounter\nsignificant delays in bringing our product candidate to market and be precluded from manufacturing or selling our product candidate.\n\n \n\nWe\ncannot be certain that others have not filed patent applications for technology covered by HJF’s pending applications, or that\nHJF the first to invent the technology, because:\n\n \n\n \n●\nsome\npatent applications in the U.S. may be maintained in secrecy until the patents are issued;\n\n \n \n \n\n \n●\npatent\napplications in the U.S. are typically not published until 18 months after the priority date; and\n\n \n \n \n\n \n●\npublications\nin the scientific literature often lag behind actual discoveries.\n\n \n\n38\n\n[Table of Contents](#toc_001)\n\n \n\nOur\ncompetitors may have filed, and may in the future file, patent applications covering technology similar to ours. Any such patent application\nmay have priority over HJF’s patent applications, which could require us to obtain rights to issued patents covering such technologies.\nIf another party has filed U.S. patent applications on inventions similar to HJF that claims priority to any applications filed prior\nto the priority dates of HJF’s applications, HJF may have to participate in an interference proceeding declared by the USPTO to\ndetermine priority of invention in the U.S. It is possible that such efforts would be unsuccessful if, unbeknownst to HJF, the other\nparty had independently arrived at the same or similar inventions prior to HFJ’s inventions, resulting in a loss of HFJ’s\nU.S. patent position with respect to such inventions which could in turn have a material adverse effect on our operations. Other countries\nhave similar laws that permit secrecy of patent applications, and may be entitled to priority over our applications in such jurisdictions.\n\n \n\nSome\nof our competitors may be able to sustain the costs of complex patent litigation more effectively than us or the third parties from whom\nwe license intellectual property because they have substantially greater resources. In addition, any uncertainties resulting from the\ninitiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue\nour operations.\n\n \n\n**If\nwe are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and\nproduct could be significantly diminished.**\n\n \n\nWe\nalso rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate\nor obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants,\noutside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information.\nThese agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event\nof unauthorized disclosure of confidential information. Furthermore, any license agreements we enter into in the future may require us\nto notify, and in some cases license back to the licensor, certain additional proprietary information or intellectual property that we\ndeveloped using the rights licensed to us under these agreements. Any such licenses back to the licensor could allow our licensors to\nuse that proprietary information or intellectual property in a manner that could harm our business. In addition, others may independently\ndiscover our trade secrets and proprietary information. For example, the FDA, as part of its transparency initiative, is currently considering\nwhether to make additional information publicly available on a routine basis, including information that we may consider to be trade\nsecrets or other proprietary information, and it is not clear at the present time how the FDA’s disclosure policies may change\nin the future, if at all. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary\nrights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.\n\n \n\n**We\nmay be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets.**\n\n \n\nAs\nis common in the biotechnology and pharmaceutical industries, we employ individuals who were previously employed at other biotechnology\nor pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants\nand independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims\nthat we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed trade secrets or other\nproprietary information of their former employers. Litigation may be necessary to defend against these claims. If we fail in defending\nany such claims, in addition to paying monetary damages, we could lose valuable intellectual property rights or personnel, which could\nadversely impact our business. Even if we are successful in defending against these claims, litigation could result in substantial costs\nand be a distraction to management.\n\n \n\n**Our\nintellectual property may not be sufficient to protect our product candidate from competition, which may negatively affect our business\nas well as limit our partnership or acquisition appeal.**\n\n \n\nWe\nmay be subject to competition despite the existence of intellectual property we license or own. We can give no assurances that our intellectual\nproperty claims will be sufficient to prevent third parties from designing around patents we own or license and developing and commercializing\ncompetitive products. The existence of competitive products that avoid our intellectual property could materially adversely affect our\noperating results and financial condition. Furthermore, limitations, or perceived limitations, in our intellectual property may limit\nthe interest of third parties to partner, collaborate or otherwise transact with us, if third parties perceive a higher than acceptable\nrisk to commercialization of our product candidate or future product candidates.\n\n \n\nWe\nmay elect to sue a third party, or otherwise make a claim, alleging infringement or other violation of patents, trademarks, trade dress,\ncopyrights, trade secrets, domain names or other intellectual property rights that we either own or license from a third party. If we\ndo not prevail in enforcing our intellectual property rights in this type of litigation, we may be subject to:\n\n \n\n \n●\npaying\nmonetary damages related to the legal expenses of the third party;\n\n \n \n \n\n \n●\nfacing\nadditional competition that may have a significant adverse effect on our product pricing, market share, business operations, financial\ncondition, and the commercial viability of our product; and\n\n \n \n \n\n \n●\nrestructuring\nour company or delaying or terminating select business opportunities, including, but not limited to, research and development, clinical\ntrial, and commercialization activities, due to a potential deterioration of our financial condition or market competitiveness.\n\n \n\n39\n\n[Table of Contents](#toc_001)\n\n \n\nA\nthird party may also challenge the validity, enforceability or scope of the intellectual property rights that we license or own; and,\nthe result of these challenges may narrow the scope or claims of or invalidate patents that are integral to our product candidate in\nthe future. There can be no assurance that we will be able to successfully defend patents we own or license in an action against third\nparties due to the unpredictability of litigation and the high costs associated with intellectual property litigation, amongst other\nfactors.\n\n \n\nIntellectual\nproperty rights and enforcement may be less extensive in jurisdictions outside of the U.S.; thus, we may not be able to protect our intellectual\nproperty and third parties may be able to market competitive products that may use some or all of our intellectual property.\n\n \n\nChanges\nto patent law, including the Leahy-Smith America Invests Act, AIA or Leahy-Smith Act, of 2011 and the Patent Reform Act of 2009 and other\nfuture article of legislation, may substantially change the regulations and procedures surrounding patent applications, issuance of patents,\nand prosecution of patents. We can give no assurances that the patents of our licensor can be defended or will protect us against future\nintellectual property challenges, particularly as they pertain to changes in patent law and future patent law interpretations.\n\n \n\nIn\naddition, enforcing and maintaining our intellectual property protection depends on compliance with various procedural, document submission,\nfee payment and other requirements imposed by the USPTO, courts and foreign government patent agencies, and HJF’s patent protection\ncould be reduced or eliminated for non-compliance with these requirements which may have a material adverse effect on our business.\n\n \n\n**Risks\nRelated to Commercialization of Our Current Product Candidate and Future Product Candidates**\n\n \n\n**Our\ncommercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates,\nif approved, among physicians, patients, healthcare payors and cancer treatment centers.**\n\n \n\nEven\nif we obtain regulatory approval for our current product candidate or any future product candidates, the products may not gain market\nacceptance among physicians, healthcare payors, patients or the medical community, including cancer treatment centers. Market acceptance\nof any product candidates for which we receive approval depends on a number of factors, including:\n\n \n\n \n●\nthe\nefficacy and safety of such product candidates as demonstrated in clinical trials;\n\n \n \n \n\n \n●\nthe\nclinical indications and patient populations for which the product candidate is approved;\n\n \n \n \n\n \n●\nacceptance\nby physicians, major cancer treatment centers and patients of the drug as a safe and effective treatment;\n\n \n \n \n\n \n●\nthe\nadoption of novel immunotherapies by physicians, hospitals and third-party payors;\n\n \n \n \n\n \n●\nthe\npotential and perceived advantages of product candidates over alternative treatments;\n\n \n \n \n\n \n●\nthe\nsafety of product candidates seen in a broader patient group, including our use outside the approved indications;\n\n \n \n \n\n \n●\nany\nrestrictions on use together with other medications;\n\n \n \n \n\n \n●\nthe\nprevalence and severity of any side effects;\n\n \n \n \n\n \n●\nproduct\nlabeling or product insert requirements of the FDA or other regulatory authorities;\n\n \n \n \n\n \n●\nthe\ntiming of market introduction of our product as well as competitive products;\n\n \n \n \n\n \n●\nthe\ndevelopment of manufacturing and distribution processes for commercial scale manufacturing for our current product candidate and\nany future product candidates;\n\n \n \n \n\n \n●\nthe\ncost of treatment in relation to alternative treatments;\n\n \n \n \n\n \n●\nthe\navailability of coverage and adequate reimbursement from third-party payors and government authorities;\n\n \n \n \n\n \n●\nrelative\nconvenience and ease of administration; and\n\n \n \n \n\n \n●\nthe\neffectiveness of our sales and marketing efforts and those of our collaborators.\n\n \n\nIf\nour current product and any future product candidates are approved but fail to achieve market acceptance among physicians, patients,\nhealthcare payors or cancer treatment centers, we will not be able to generate significant revenues, which would compromise our ability\nto become profitable.\n\n \n\n40\n\n[Table of Contents](#toc_001)\n\n** **\n\n**Even\nif we are able to commercialize our current product candidate or any future product candidates, the products may not receive coverage\nand adequate reimbursement from third-party payors in the U.S. and in other countries in which we seek to commercialize our products,\nwhich could harm our business.**\n\n \n\nOur\nability to commercialize any product successfully will depend, in part, on the extent to which coverage and adequate reimbursement for\nsuch product and related treatments will be available from third-party payors, including government health administration authorities,\nprivate health insurers and other organizations.\n\n \n\nThird-party\npayors determine which medications they will cover and establish reimbursement levels. A primary trend in the healthcare industry is\ncost containment. Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular\nmedications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices\nand are challenging the prices charged for medical products. Third-party payors may also seek additional clinical evidence, beyond the\ndata required to obtain regulatory approval, demonstrating clinical benefit and value in specific patient populations before covering\nour product for those patients. We cannot be sure that coverage and adequate reimbursement will be available for any product that we\ncommercialize and, if coverage is available, what the level of reimbursement will be. Coverage and reimbursement may impact the demand\nfor, or the price of, any product candidate for which we obtain regulatory approval. If reimbursement is not available or is available\nonly at limited levels, we may not be able to successfully commercialize any product candidate for which we obtain regulatory approval.\n\n \n\nThere\nmay be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the\npurposes for which the drug is approved by the FDA or comparable foreign regulatory authorities. Moreover, eligibility for coverage and\nreimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development,\nmanufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our\ncosts and may only be temporary. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is\nused, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other\nservices. Net prices for drugs may be reduced by mandatory discounts or rebates required by third-party payors and by any future relaxation\nof laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the U.S. No uniform policy\nfor coverage and reimbursement exists in the U.S., and coverage and reimbursement can differ significantly from payor to payor. Third-party\npayors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies, but also have their\nown methods and approval process apart from Medicare determinations. Our inability to promptly obtain coverage and profitable reimbursement\nrates from both government-funded and private payors for any approved product that we develop could have a material adverse effect on\nour operating results, ability to raise capital needed to commercialize our product and overall financial condition.\n\n \n\n**Healthcare\nlegislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.**\n\n \n\nThird-party\npayors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling\nhealthcare costs. In both the U.S. and certain international jurisdictions, there have been a number of legislative and regulatory changes\nto the health care system that could impact our ability to sell our product profitably. In particular, in 2010, the Affordable Care Act\n(“ACA”) was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars,\naddressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that\nare inhaled, infused, instilled, implanted or injected, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid\nDrug Rebate Program, extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed\ncare organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives\nto programs that increase the federal government’s comparative effectiveness research. Since its enactment, there have been judicial\nand Congressional challenges to certain aspects of the ACA, as well as recent efforts by the current U.S. administration to repeal or\nrepeal and replace certain aspects of the ACA. On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas, or\nthe Texas District Court Judge, ruled that the individual mandate is a critical and inseverable feature of the ACA, and therefore, because\nit was repealed as a part of the Tax Act, the remaining provisions of the ACA are invalid as well. While the Texas District Court Judge,\nas well as the Trump Administration and CMS, have stated that the ruling will have no immediate effect, it is unclear how this decision,\nsubsequent appeals and other efforts to repeal and replace the ACA will impact the ACA. Until there is more certainty concerning the\nfuture of the ACA, it will be difficult to predict its full impact and influence on our business.\n\n \n\nIn\naddition, other legislative changes have been proposed and adopted in the U.S. since the ACA was enacted. In August 2011, the Budget\nControl Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction,\ntasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach\nrequired goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate\nreductions of Medicare payments to providers of 2% per fiscal year, which went into effect in 2013, and will remain in effect through\n2027 unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012 further reduced Medicare payments to several\nproviders, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover\noverpayments to providers from three to five years.\n\n \n\nThere\nhave been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at\ncontaining or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future. The continuing efforts\nof the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs\nof healthcare and/or impose price controls may adversely affect:\n\n \n\n \n●\nthe\ndemand for our product candidate, if we obtain regulatory approval;\n\n \n \n \n\n \n●\nour\nability to receive or set a price that we believe is fair for our product;\n\n \n \n \n\n \n●\nour\nability to generate revenue and achieve or maintain profitability;\n\n \n\n41\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\nthe\nlevel of taxes that we are required to pay; and\n\n \n \n \n\n \n●\nthe\navailability of capital.\n\n \n\nWe\nexpect that the ACA, as well as other healthcare reform measures that may be adopted in the future, may result in additional reductions\nin Medicare and other healthcare funding, more rigorous coverage criteria, lower reimbursement and new payment methodologies. This could\nlower the price that we receive for any approved product. Any denial in coverage or reduction in reimbursement from Medicare or other\ngovernment-funded programs may result in a similar denial or reduction in payments from private payors, which may prevent us from being\nable to generate sufficient revenue, attain profitability or commercialize our product candidate, if approved.\n\n \n\n**Price\ncontrols may be imposed in foreign markets, which may adversely affect our future profitability.**\n\n \n\nIn\nsome countries, particularly member states of the European Union, the pricing of prescription drugs is subject to governmental control.\nIn these countries, pricing negotiations with governmental authorities can take considerable time after receipt of regulatory approval\nfor a product. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels,\nincluding as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations,\nand pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various European Union member\nstates and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.\n\n \n\nIn\nsome countries, we or our collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness\nof our product candidate to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of\ndiscounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country\nof publication and other countries. If reimbursement of our product is unavailable or limited in scope or amount, or if pricing is set\nat unsatisfactory levels, our business could be adversely affected.\n\n \n\n**Coverage\nand reimbursement may be limited or unavailable in certain market segments for our product candidate, which could make it difficult for\nus to sell our product candidates, if licensed, profitably.**\n\n \n\nSuccessful\ncommercialization of our product candidate will depend in part on the extent to which reimbursement for those drug products will be available\nfrom government health administration authorities, private health insurers, and other organizations. Government authorities and third-party\npayors, such as private health insurers and health maintenance organizations, decide which drug products they will pay for and establish\nreimbursement levels. The availability and extent of reimbursement by governmental and private payors is essential for most patients\nto be able to afford a drug product. Sales of drug products depend substantially, both domestically and abroad, on the extent to which\nthe costs of drugs products are paid for by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations,\nor reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. Significant\nuncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval. Any\nproduct candidate for which we seek regulatory approval and reimbursement will need to meet or surpass our target product profile to\nbe deemed a viable alternative to currently approved therapies.\n\n \n\nThird-party\npayors decide which drugs and treatments they will cover and the amount of reimbursement. Reimbursement by a third-party payor may depend\nupon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is:\n\n \n\n \n●\na\ncovered benefit under its health plan;\n\n \n \n \n\n \n●\nsafe,\neffective and medically necessary;\n\n \n \n \n\n \n●\nappropriate\nfor the specific patient;\n\n \n \n \n\n \n●\ncost-effective;\nand\n\n \n \n \n\n \n●\nneither\nexperimental nor investigational.\n\n \n\nObtaining\ncoverage and reimbursement of a product from a government or other third-party payor is a time-consuming and costly process that could\nrequire us to provide the payor with supporting scientific, clinical and cost-effectiveness data for the use of our products, if licensed.\nIn the U.S., the principal decisions about reimbursement for new drug products are typically made by the Centers for Medicare and Medicaid\nServices, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS. CMS decides whether and to what extent a\nnew drug product will be covered and reimbursed under Medicare, and private payors tend to follow CMS to a substantial degree. However,\nno uniform policy of coverage and reimbursement for drug products exists among third-party payors and coverage and reimbursement levels\nfor drug products can differ significantly from payor to payor. Further, one payor’s determination to provide coverage for a product\ndoes not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available\nto enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.\n\n \n\nEven\nif we obtain coverage for a given product, if the resulting reimbursement rates are insufficient, hospitals may not approve our product\nfor use in their facility or third-party payors may require co-payments that patients find unacceptably high. Patients are unlikely to\nuse our product candidates unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our\nproduct candidates. Separate reimbursement for the product itself may or may not be available. Instead, the hospital or administering\nphysician may be reimbursed only for providing the treatment or procedure in which our product is used. Further, from time to time, CMS\nrevises the reimbursement systems used to reimburse health care providers, including the Medicare Physician Fee Schedule and Outpatient\nProspective Payment System, which may result in reduced Medicare payments. In some cases, private third-party payors rely on all or portions\nof Medicare payment systems to determine payment rates. Changes to government healthcare programs that reduce payments under these programs\nmay negatively impact payments from private third-party payors, and reduce the willingness of physicians to use our product candidates.\n\n \n\n42\n\n[Table of Contents](#toc_001)\n\n \n\nThe\nmarketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other\nthird-party payors fail to provide coverage and adequate reimbursement. We expect downward pressure on pharmaceutical pricing to continue.\nFurther, coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status\nis attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates\nmay be implemented in the future.\n\n \n\n**We\nexpect the product candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to\ncompetition.**\n\n \n\nThe\nBiologics Price Competition and Innovation Act of 2009, or BPCIA, was enacted as part of the Patient Protection and Affordable Care Act,\nas amended by the Health Care and Education Reconciliation Act, or collectively the ACA, to establish an abbreviated pathway for the\napproval of biosimilar and interchangeable biological products. The regulatory pathway establishes legal authority for the FDA to review\nand approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity\nto a licensed biologic. Under the BPCIA, an application for a biosimilar product cannot be licensed by the FDA until 12 years after the\nreference product was licensed under a BLA. The law is complex and is still being interpreted and implemented by the FDA.\n\n \n\nWe\nbelieve that any of the product candidates we develop that is licensed in the U.S. as a biological product under a BLA should qualify\nfor the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action\nor otherwise, or that the FDA will not consider the subject product candidates to be reference products for competing products, potentially\ncreating the opportunity for generic competition sooner than anticipated. Moreover, the extent to which a biosimilar, once licensed,\nwill be substituted for any one of the reference products in a way that is similar to traditional generic substitution for non-biological\nproducts is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.\n\n \n\n**Risks\nRelated to Healthcare Compliance Regulations**\n\n \n\n**Our\nrelationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare\nlaws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished\nprofits and future earnings. If we or they are unable to comply with these provisions, we may become subject to civil and criminal investigations\nand proceedings that could have a material adverse effect on our business, financial condition and prospects.**\n\n \n\nHealthcare\nproviders, physicians and third-party payors will play a primary role in the recommendation and prescription of any product candidates\nfor which we obtain regulatory approval. Our current and future arrangements with healthcare providers, healthcare entities, third-party\npayors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain\nthe business or financial arrangements and relationships through which we research, develop and will market, sell and distribute our\nproduct. As a pharmaceutical company, even though we do not and will not control referrals of healthcare services or bill directly to\nMedicare, Medicaid or other third-party payors, federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’\nrights are applicable to our business. Restrictions under applicable federal and state healthcare laws and regulations that may affect\nour ability to operate include the following:\n\n \n\n \n●\nthe\nfederal healthcare Anti-Kickback Statute which prohibits, among other things, individuals and entities from knowingly and willfully\nsoliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce\nor reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service,\nfor which payment may be made under a federal healthcare program such as Medicare and Medicaid;\n\n \n \n \n\n \n●\nfederal\ncivil and criminal false claims laws, including the federal False Claims Act that can be enforced through civil whistleblower or\nqui tam actions, and civil monetary penalty laws, prohibit individuals or entities from knowingly presenting, or causing to be presented,\nto the federal government, including the Medicare and Medicaid programs, claims for payment or approval that are false or fraudulent\nor making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;\n\n \n \n \n\n \n●\nthe\nfederal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) which imposes criminal and civil liability\nfor executing a scheme to defraud any healthcare benefit program and also created federal criminal laws that prohibit knowingly and\nwillfully falsifying, concealing or covering up a material fact or making any materially false statements in connection with the\ndelivery of or payment for healthcare benefits, items or services, as amended by the Health Information Technology for Economic and\nClinical Health Act of 2009 (“HITECH”) which imposes obligations, including mandatory contractual terms, with respect\nto safeguarding the privacy, security and transmission of individually identifiable health information on entities subject to the\nlaw, such as certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, and their respective\nbusiness associates that perform services for them that involve the creation, use, maintenance or disclosure of, individually identifiable\nhealth information;\n\n \n \n \n\n \n●\nthe\nfederal physician sunshine requirements under the ACA which requires certain manufacturers of drugs, devices, biologics and medical\nsupplies, with certain exceptions, to report annually to HHS information related to payments and other transfers of value to physicians,\nother healthcare providers, and teaching hospitals, and ownership and investment interests held by physicians and other healthcare\nproviders and their immediate family members and applicable group purchasing organizations;\n\n \n\n43\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\nanalogous\nstate and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing\narrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private\ninsurers; some state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance\nguidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report\ninformation related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures\nor pricing information; and certain state and local laws which require the registration of pharmaceutical sales representatives;\nand\n\n \n \n \n\n \n●\nstate\nand foreign laws govern the privacy and security of health information in specified circumstances, many of which differ from each\nother in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.\n\n \n\nEfforts\nto ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve\nsubstantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current\nor future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations\nare found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant\ncivil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, exclusion from government funded healthcare\nprograms, such as Medicare and Medicaid, integrity oversight and reporting obligations, and the curtailment or restructuring of our operations.\nIf any physicians or other healthcare providers or entities with whom we expect to do business are found to not be in compliance with\napplicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare\nprograms.\n\n \n\n**Our\nemployees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements,\nwhich could cause significant liability for us and harm our reputation.**\n\n \n\nWe\nare exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with FDA regulations or similar\nregulations of comparable foreign regulatory authorities, provide accurate information to the FDA or comparable foreign regulatory authorities,\ncomply with manufacturing standards we have established, comply with federal and state healthcare fraud and abuse laws and regulations\nand similar laws and regulations established and enforced by comparable foreign regulatory authorities, report financial information\nor data accurately or disclose unauthorized activities to us. Employee misconduct could also involve the improper use of information\nobtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always\npossible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may not be effective\nin controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits\nstemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are\nnot successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results\nof operations, including the imposition of significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion\nfrom government funded healthcare programs, such as Medicare and Medicaid, and integrity oversight and reporting obligations.\n\n \n\n**Product\nliability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we\nmay develop.**\n\n \n\nWe\nface an inherent risk of product liability exposure related to the testing of our current product candidate or future product candidates\nin human clinical trials and will face an even greater risk if we commercially sell any products that we may develop. Product liability\nclaims may be brought against us by patients enrolled in our clinical trials, patients, healthcare providers or others using, administering\nor selling our product. If we cannot successfully defend ourselves against claims that our product candidate or product caused injuries,\nwe could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:\n\n \n\n \n●\ndecreased\ndemand for any product candidates or products that we may develop;\n\n \n \n \n\n \n●\ntermination\nof clinical trial sites or entire clinical trial programs;\n\n \n \n \n\n \n●\ninjury\nto our reputation and significant negative media attention;\n\n \n \n \n\n \n●\nwithdrawal\nof clinical trial participants;\n\n \n \n \n\n \n●\nsignificant\ncosts to defend the related litigation;\n\n \n \n \n\n \n●\nsubstantial\nmonetary awards to clinical trial patients;\n\n \n \n \n\n \n●\nloss\nof revenue;\n\n \n \n \n\n \n●\ndiversion\nof management and scientific resources from our business operations; and\n\n \n \n \n\n \n●\nthe\ninability to commercialize any products that we may develop.\n\n \n\n44\n\n[Table of Contents](#toc_001)\n\n \n\nPrior\nto engaging in future clinical trials, we intend to obtain product liability insurance coverage at a level that we believe is customary\nfor similarly situated companies and adequate to provide us with insurance coverage for foreseeable risks; however, we may be unable\nto obtain such coverage at a reasonable cost, if at all. If we are able to obtain product liability insurance, we may not be able to\nmaintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise and such insurance\nmay not be adequate to cover all liabilities that we may incur. Furthermore, we intend to expand our insurance coverage for products\nto include the sale of commercial products if we obtain regulatory approval for our product candidate in development, but we may be unable\nto obtain commercially reasonable product liability insurance for any products that receive regulatory approval. Large judgments have\nbeen awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series\nof claims brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash and adversely affect our\nbusiness.\n\n \n\n**Laws\nand regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling\ncertain products outside of the U.S. and require us to develop and implement costly compliance programs.**\n\n \n\nIf\nwe expand our operations outside of the U.S., we must dedicate additional resources to comply with numerous laws and regulations in each\njurisdiction in which we plan to operate. The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from\npaying, offering, authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party\nor candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in\nobtaining or retaining business. The FCPA also obligates companies whose securities are listed in the U.S. to comply with certain accounting\nprovisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation,\nincluding international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international\noperations.\n\n \n\nCompliance\nwith the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA\npresents particular challenges in the pharmaceutical industry, because, in many countries, hospitals are operated by the government,\nand doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical\ntrials and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.\n\n \n\nVarious\nlaws, regulations and Executive Orders also restrict the use and dissemination outside of the U.S., or the sharing with certain non-U.S.\nnationals, of information classified for national security purposes, as well as certain products and technical data relating to those\nproducts. If we expand our presence outside of the U.S., it will require us to dedicate additional resources to comply with these laws,\nand these laws may preclude us from developing, manufacturing, marketing or selling certain products and product candidates outside of\nthe U.S., which could limit our growth potential and increase our development costs.\n\n \n\nThe\nfailure to comply with laws governing international business practices may result in substantial civil and criminal penalties and suspension\nor debarment from government contracting. The SEC also may suspend or bar issuers from trading securities on U.S. exchanges for violations\nof the FCPA’s accounting provisions.\n\n \n\n**Risks\nRelated to our Business Operations**\n\n \n\n**We\nface substantial competition, which may result in others discovering, developing or commercializing products before or more successfully\nthan we do.**\n\n \n\nWe\nface competition from numerous pharmaceutical and biotechnology enterprises, as well as from academic institutions, government agencies\nand private and public research institutions for our current product candidate. Our commercial opportunities will be reduced or eliminated\nif our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than\nany products that we may develop. Competition could result in reduced sales and pricing pressure on our current product candidate, if\napproved, which in turn would reduce our ability to generate meaningful revenues and have a negative impact on our results of operations.\nIn addition, significant delays in the development of our product candidate could allow our competitors to bring products to market before\nwe do and impair our ability to commercialize our product candidate. The biotechnology industry, including the cancer immunotherapy market,\nis intensely competitive and involves a high degree of risk. We compete with other companies that have far greater experience and financial,\nresearch and technical resources than us. Potential competitors in the U.S. and worldwide are numerous and include pharmaceutical and\nbiotechnology companies, educational institutions and research foundations, many of which have substantially greater capital resources,\nmarketing experience, research and development staffs and facilities than ours. Some of our competitors may develop and commercialize\nproducts that compete directly with those incorporating our technology or may introduce products to market earlier than our product or\non a more cost-effective basis. Our competitors compete with us in recruiting and retaining qualified scientific and management personnel\nas well as in acquiring technologies complementary to our technology. We may face competition with respect to product efficacy and safety,\nease of use and adaptability to various modes of administration, acceptance by physicians, the timing and scope of regulatory approvals,\navailability of resources, reimbursement coverage, price and patent position, including the potentially dominant patent positions of\nothers. An inability to successfully complete our product development or commercializing our product candidate could result in our having\nlimited prospects for establishing market share or generating revenue.\n\n \n\n45\n\n[Table of Contents](#toc_001)\n\n \n\nMany\nof our competitors or potential competitors have significantly greater established presence in the market, financial resources and expertise\nin research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing\napproved products than we do, and as a result may have a competitive advantage over us. Mergers and acquisitions in the pharmaceutical\nand biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller\nor early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and\nestablished companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel,\nestablishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies and technology licenses\ncomplementary to our programs or potentially advantageous to our business.\n\n \n\nAs\na result of these factors, these competitors may obtain regulatory approval of their products before we are able to obtain patent protection\nor other intellectual property rights, which will limit our ability to develop or commercialize our current product candidate. Our competitors\nmay also develop drugs that are safer, more effective, more widely used and cheaper than ours, and may also be more successful than us\nin manufacturing and marketing their products. These appreciable advantages could render our product candidate obsolete or noncompetitive\nbefore we can recover the expenses of development and commercialization.\n\n \n\n**The\nCOVID-19 coronavirus could adversely impact our business in the U.S. and in other countries, including several key activities, including\nclinical trial activities, manufacturing of drugs and clinical supplies, exportation of drug and supplies, and management of international\npayments and cash flow that are critical to our success.**\n\n \n\nThe\nglobal outbreak of COVID-19 continues to rapidly evolve, including the emergence of new strains that could have the potential to be as\nharmful as or more harmful than the original strains in 2020. As a result, businesses may close, staffing may be reduced, including clinical\nstaffs, and limits may be placed on travel. The extent to which COVID-19 may impact our business will depend on future developments,\nwhich are highly uncertain and cannot be predicted with confidence, such as the ultimate impact of the disease on specific geographies,\nthe duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or\nbusiness disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.\n\n \n\nThe\nspread of COVID-19 throughout the world has also created global economic uncertainty, which may cause partners, suppliers and potential\ncustomers to closely monitor their costs and reduce their spending budget. Any of the foregoing could materially adversely affect our\nresearch and development activities, clinical trials, supply chain, financial condition and cash flows.\n\n \n\nIf\nthe COVID-19 outbreak continues to spread and evolve, we may need to limit operations or implement other limitations on our activities.\nThere is a risk that countries or regions outside the United States may be less effective at vaccinations and containing COVID-19, in\nwhich case the risks described herein could be elevated significantly.\n\n \n\n**Data\ncollection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.**\n\n \n\nWe\nare subject to stringent privacy and data protection requirements and these requirements may become more complex as we grow our business\nand begin to operate in other jurisdictions. For example, the collection, use, storage, disclosure, transfer, or other processing of\npersonal data, including health-related information, regarding individuals in the European Economic Area, or EEA, is governed by the\nEuropean General Data Protection Regulation, or the GDPR, which became effective on May 25, 2018. The GDPR applies to any business, regardless\nof its location, that provides goods or services to residents in the EU or monitors the behavior of individuals within the European Union.\nThe GDPR is wide ranging in scope and imposes stringent operational requirements for processors and controllers of personal data, including,\nfor example, special protections for “sensitive information” which includes health and genetic information, expanded disclosures\nto individuals about how their personal data is to be used, limitations on retention of information, increased requirements pertaining\nto health data and pseudonymized (*i.e.*, key-coded) data, implementing safeguards to protect the security and confidentiality of\npersonal data, mandatory data breach notification requirements and higher standards for controllers to demonstrate that they have obtained\nvalid consent for certain data processing activities. The GDPR grants individuals the opportunity to object to the processing of their\npersonal information, allows them to request deletion of personal information in certain circumstances, and provides the individual with\nan express right to seek legal remedies in the event the individual believes his or her rights have been violated. Further, the GDPR\nimposes strict rules on the transfer of personal data out of the European Union to the U.S. and other jurisdictions that have not been\ndeemed to offer “adequate” privacy protections.\n\n \n\nIn\naddition to the requirement of the GDPR, European Union Member States may make their own further laws and regulations in relation to\nthe processing of genetic, biometric or health data, which could result in differences between Member States, limit our ability to use\nand share personal data or could cause our costs to increase, and harm our business and financial condition. Should we commence clinical\ntrial activity within the member states of the European Union, such activity will be regulated by the GDPR as well as applicable member\nstate laws. In addition, we are subject to evolving and strict rules on the transfer of personal data out of the European Union to the\nU.S.. For example, evolution of laws governing the cross-border transfer of data, such as the invalidation of the EU–U.S. Privacy\nShield, creates additional uncertainty around the legality and mechanics of such transfers. Compliance with the GDPR will be a rigorous\nand time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those\nefforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with any future\nEuropean activities. We could be adversely affected if we fail to comply fully with all of these requirements. Failure to comply with\nEuropean Union data protection laws may result in fines (for example, of up to €20,000,000 or up to 4% of the total worldwide annual\nturnover of the preceding financial year (whichever is higher) under the GDPR) and other administrative penalties, which may be onerous\nand adversely affect our business, financial condition, results of operations and prospects.\n\n \n\n46\n\n[Table of Contents](#toc_001)\n\n \n\nIn\naddition, further to the United Kingdom’s (UK) exit from the EU on January 31, 2020, the GDPR ceased to apply in the UK at the\nend of the transition period on December 31, 2020. However, as of January 1, 2021, the UK’s European Union (Withdrawal) Act 2018\nincorporated the GDPR (as it existed on December 31, 2020 but subject to certain UK specific amendments) into UK law (referred to as\nthe ‘UK GDPR’). The UK GDPR and the UK Data Protection Act 2018 set out the UK’s data protection regime, which is independent\nfrom but aligned to the EU’s data protection regime. Non-compliance with the UK GDPR may result in monetary penalties of up to\n£17.5 million or 4% of worldwide revenue, whichever is higher. Although the UK is regarded as a third country under the EU’s\nGDPR, the European Commission has now issued a decision recognizing the UK as providing adequate protection under the EU GDPR and, therefore,\ntransfers of personal data originating in the EU to the UK remain unrestricted. Like the EU GDPR, the UK GDPR restricts personal data\ntransfers outside the UK to countries not regarded by the UK as providing adequate protection. The UK government has confirmed that personal\ndata transfers from the UK to the EEA remain free flowing.\n\n \n\nThis\nlack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, uncertainty,\ncomplexity and cost to our handling of EU personal information and our privacy and data security compliance programs. It is possible\nthat over time the UK Data Protection Act could become less aligned with the EU General Data Protection Regulation, or GDPR, which could\nrequire us to implement different compliance measures for the UK and the European Union and result in potentially enhanced compliance\nobligations for EU personal data.\n\n \n\nIn\nthe U.S., there has been a flurry of activity at the state level. In California, the California Consumer Privacy Act, or CCPA, was enacted\nin June 2018, became effective on January 1, 2020, and became subject to enforcement by the California Attorney General’s office\non July 1, 2020. The CCPA broadly defines personal information, and creates new individual privacy rights and protections for California\nconsumers (as defined in the law), places increased privacy and security obligations on entities handling personal data of consumers\nor households, and provides for civil penalties for violations and a private right of action for data breaches. The CCPA requires covered\ncompanies to provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California\nresidents with ways to opt-out of certain sales or transfers of personal information. While there is an exception for protected health\ninformation that is subject to HIPAA and clinical trial regulations, the CCPA may impact our business activities if we become a “Business”\nregulated by the scope of the CCPA.\n\n \n\nIn\naddition to the CCPA, new privacy and data security laws have been proposed in more than half of the states in the U.S. and in the U.S.\nCongress, reflecting a trend toward more stringent privacy legislation in the U.S., which trend may accelerate depending on the new U.S.\npresidential administration. The effects of the CCPA, and other similar state or federal laws, are potentially significant and may require\nus to modify our data processing practices and policies and to incur substantial costs and potential liability in an effort to comply\nwith such legislation.\n\n \n\nFurther,\nvarious jurisdictions around the world continue to propose new laws that regulate the privacy and/or security of certain types of personal\ndata. Complying with these laws, if enacted, would require significant resources and leave us vulnerable to possible fines and penalties\nif we are unable to comply. The regulatory framework governing the collection, processing, storage, use and sharing of certain information\nis rapidly evolving and is likely to continue to be subject to uncertainty and varying interpretations. It is possible that these laws\nmay be interpreted and applied in a manner that is inconsistent with our existing data management practices or the features of our services\nand platform capabilities. Any failure or perceived failure by us, or any third parties with which we do business, to comply with our\nposted privacy policies, evolving laws, rules and regulations, industry standards, or contractual obligations to which we or such third\nparties are or may become subject, may result in actions or other claims against\n\n \n\n47\n\n[Table of Contents](#toc_001)\n\n \n\n**Significant\ndisruptions of information technology systems, computer system failures or breaches of information security could adversely affect our\nbusiness.**\n\n \n\nWe\nrely to a large extent upon sophisticated information technology systems to operate our business. In the ordinary course of business,\nwe collect, store and transmit large amounts of confidential information (including, but not limited to, personal information and intellectual\nproperty). The size and complexity of our information technology and information security systems, and those of our third-party vendors\nwith whom we may contract, make such systems potentially vulnerable to service interruptions or to security breaches from inadvertent\nor intentional actions by our employees or vendors, or from malicious attacks by third parties. Such attacks are of ever-increasing levels\nof sophistication and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage\nand market manipulation) and expertise. While we intend to invest in the protection of data and information technology, there can be\nno assurance that our efforts will prevent service interruptions or security breaches.\n\n \n\nOur\ninternal computer systems, and those of our CROs, our CMOs, and other business vendors on which we may rely, are vulnerable to damage\nfrom computer viruses, unauthorized access, natural disasters, fire, terrorism, war and telecommunication and electrical failures. We\nexercise little or no control over these third parties, which increases our vulnerability to problems with their systems. If such an\nevent were to occur and cause interruptions in our operations, it could result in a material disruption of our drug development programs.\nAny interruption or breach in our systems could adversely affect our business operations and/or result in the loss of critical or sensitive\nconfidential information or intellectual property, and could result in financial, legal, business and reputational harm to us or allow\nthird parties to gain material, inside information that they use to trade in our securities. For example, the loss of clinical trial\ndata from completed or ongoing clinical trials could result in delays in our regulatory approval efforts and significantly increase our\ncosts to recover or reproduce the data. To the extent that any disruption or security breach results in a loss of or damage to our data\nor applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, the further development\nof our current and future product candidates could be delayed and our business could be otherwise adversely affected.\n\n \n\n**We\nwill need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.**\n\n \n\nAs\nof May 26, 2026, we had 4 full-time employees and 9 part-time employees. We will need to grow the size of our organization in\norder to support our continued development and potential commercialization of our product candidate. As our development and\ncommercialization plans and strategies continue to develop, our need for additional managerial, operational, manufacturing, sales,\nmarketing, financial and other resources may increase. Our management, personnel and systems currently in place may not be adequate\nto support this future growth. Future growth would impose significant added responsibilities on members of management,\nincluding:\n\n \n\n \n●\nmanaging\nour clinical trials effectively;\n\n \n \n \n\n \n●\nidentifying,\nrecruiting, maintaining, motivating and integrating additional employees;\n\n \n \n \n\n \n●\nmanaging\nour internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors\nand other third parties;\n\n \n \n \n\n \n●\nimproving\nour managerial, development, operational, information technology, and finance systems; and\n\n \n \n \n\n \n●\nexpanding\nour facilities.\n\n \n\n48\n\n[Table of Contents](#toc_001)\n\n \n\nIf\nour operations expand, we will also need to manage additional relationships with various strategic partners, suppliers and other third\nparties. Our future financial performance and our ability to commercialize our product candidate and to compete effectively will depend,\nin part, on our ability to manage any future growth effectively, as well as our ability to develop a sales and marketing force when appropriate\nfor our company. To that end, we must be able to manage our development efforts and preclinical studies and clinical trials effectively\nand hire, train and integrate additional management, research and development, manufacturing, administrative and sales and marketing\npersonnel. The failure to accomplish any of these tasks could prevent us from successfully growing our company.\n\n \n\n**Our\nfuture success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.**\n\n \n\nWe\nare highly dependent upon our personnel, including Snehal Patel, our Chief Executive Officer and member of our board of directors. The\nloss of Mr. Patel’s services could impede the achievement of our research, development and commercialization objectives. We have\nnot obtained, do not own, nor are we the beneficiary of, key-person life insurance. Our future growth and success depend on our ability\nto recruit, retain, manage and motivate our employees. The loss of any member of our senior management team or the inability to hire\nor retain experienced management personnel could compromise our ability to execute our business plan and harm our operating results.\nBecause of the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified\nscientific, technical and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense and as\na result, we may be unable to continue to attract and retain qualified personnel necessary for the development of our business.\n\n \n\n**Inadequate\nfunding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel,\nprevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from\nperforming normal business functions on which the operation of our business may rely, which could negatively impact our business.**\n\n \n\nThe\nability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding\nlevels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.\nAverage review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other\ngovernment agencies on which our operations may rely, including those that fund research and development activities is subject to the\npolitical process, which is inherently fluid and unpredictable.\n\n \n\nDisruptions\nat the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies,\nwhich would adversely affect our business. For example, over the last several years, including beginning on December 22, 2018, the U.S.\ngovernment has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA,\nSEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact\nthe ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.\nFurther, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and\nobtain necessary capital in order to properly capitalize and continue our operations.\n\n \n\n**We\nare periodically involved in various litigation and/or regulatory proceedings that, if adversely decided or settled, could materially\nand adversely affect our business, financial condition, and results of operations.**\n\n \n\nWe\nare periodically party to or the subject of litigation, investigations, regulatory proceedings or other disputes. In general, claims\nmade by or against us in disputes and other legal or regulatory proceedings can be expensive and time consuming to bring or defend against,\nrequiring us to expend significant resources and divert the efforts and attention of our management and other personnel from our business\noperations. While we intend to pursue any claims made by us, or vigorously defend against any claims brought against us, we cannot predict\nthe outcomes of such claims. Any failure to prevail in any claims made by us or any adverse determination against us in these legal and/or\nregulatory proceedings, or even the allegations contained in such proceedings, regardless of whether they are ultimately found to be\nwithout merit, may also result in settlements, injunctions, fines, penalties, or damages that could have a material adverse effect on\nour business, financial condition and results of operations.\n\n \n\n**We\nmay hold cash and cash equivalents at various foreign subsidiaries and in countries outside of the US that may not be readily available\nto meet cash requirements.**\n\n \n\nCurrently\na majority of our cash and cash equivalents is held by our U.S. parent company, however, our foreign subsidiary may in the future hold\ncash. Our U.S. parent company or our foreign subsidiary may hold cash balances outside the United States which may not be readily available,\nor may not be available without an additional tax burden, to meet our domestic or foreign cash requirements. U.S. tax laws may allow\nfor reductions to the potential tax burden on repatriation of foreign cash; however, such actions would require us to record additional\nincome tax expense and remit additional taxes, which could have a material adverse effect on our results of operations, cash flows and\nfinancial condition. In addition, foreign exchange rates may fluctuate leading to unexpected losses and inefficient utilization of cash\nin countries outside of the U.S.\n\n \n\n**We\nmay be adversely affected by the effects of inflation and a potential recession.**\n\n \n\nInflation\nhas the potential to adversely affect our liquidity, business, financial condition, and results of operations by increasing our overall\ncost structure. The existence of inflation in the economy has resulted in, and may continue to result in, higher interest rates and capital\ncosts, shipping costs, supply shortages, increased costs of labor, weakening exchange rates, and other similar effects. As a result of\ninflation, we have experienced and may continue to experience, cost increases. In addition, poor economic and market conditions, including\na potential recession, may negatively impact market sentiment, which would adversely affect our results of operations. If we are unable\nto take effective measures in a timely manner to mitigate the impact of the inflation as well as a potential recession, our business,\nfinancial condition, and results of operations could be adversely affected.\n\n \n\n**Risks\nRelated to Owning our Common Stock**\n\n \n\n**The\nprice of our common stock may fluctuate substantially.**\n\n \n\nYou\nshould consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand a\nsignificant loss and wide fluctuations in the market value of your investment. Some factors that may cause the market price of our common\nstock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section and elsewhere in this Annual\nReport on Form 10-K, are:\n\n \n\n \n●\nsale\nof our common stock by our stockholders, executives and directors;\n\n \n \n \n\n \n●\nvolatility\nand limitations in trading volumes of our shares of common stock;\n\n \n \n \n\n \n●\nour\nability to obtain financings to conduct and complete research and development activities including, but not limited to, our clinical\ntrials, and other business activities;\n\n \n \n \n\n \n●\npossible\ndelays in the expected recognition of revenue due to lengthy and sometimes unpredictable sales timelines;\n\n \n \n \n\n \n●\nthe\ntiming and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our\nindustry, including consolidation among competitors, customers or strategic partners;\n\n \n \n \n\n \n●\nnetwork\noutages or security breaches;\n\n \n \n \n\n \n●\nour\nability to attract new customers;\n\n \n \n \n\n \n●\nour\nability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;\n\n \n \n \n\n \n●\ncommencement,\nenrollment or results of our clinical trials for our product candidate or any future clinical trials we may conduct;\n\n \n\n49\n\n[Table of Contents](#toc_001)\n\n \n\n \n●\nchanges\nin the development status of our product candidate;\n\n \n \n \n\n \n●\nany\ndelays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned preclinical\nand clinical trials;\n\n \n \n \n\n \n●\nany\ndelay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory\napproval for our product candidate;\n\n \n \n \n\n \n●\nunanticipated\nsafety concerns related to the use of our product candidate;\n\n \n \n \n\n \n●\nfailures\nto meet external expectations or management guidance;\n\n \n \n \n\n \n●\nchanges\nin our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our stockholders;\n\n \n \n \n\n \n●\nour\ncash position;\n\n \n \n \n\n \n●\nannouncements\nand events surrounding financing efforts, including debt and equity securities;\n\n \n \n \n\n \n●\nour\ninability to enter into new markets or develop new products;\n\n \n \n \n\n \n●\nreputational\nissues;\n\n \n \n \n\n \n●\ncompetition\nfrom existing technologies and products or new technologies and products that may emerge;\n\n \n \n \n\n \n●\nannouncements\nof acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;\n\n \n \n \n\n \n●\nchanges\nin general economic, political and market conditions in or any of the regions in which we conduct our business;\n\n \n \n \n\n \n●\nchanges\nin industry conditions or perceptions;\n\n \n \n \n\n \n●\nchanges\nin valuations of similar companies or groups of companies;\n\n \n \n \n\n \n●\nanalyst\nresearch reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;\n\n \n \n \n\n \n●\ndepartures\nand additions of key personnel;\n\n \n \n \n\n \n●\ndisputes\nand litigations related to intellectual properties, proprietary rights, and contractual obligations;\n\n \n \n \n\n \n●\nchanges\nin applicable laws, rules, regulations, or accounting practices and other dynamics; and\n\n \n \n \n\n \n●\nother\nevents or factors, many of which may be out of our control.\n\n \n\nIn\naddition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences\na loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition\nand results of operations. If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that,\neven if unsuccessful, could be costly to defend and a distraction to management.\n\n \n\n**Market\nand economic conditions may negatively impact our business, financial condition and share price.**\n\n \n\nConcerns\nover medical epidemics, energy costs, geopolitical issues, the U.S. mortgage market and a deteriorating real estate market, unstable\nglobal credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished\nliquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the global\neconomy and expectations of slower global economic growth, increased unemployment rates, and increased credit defaults in recent years.\nOur general business strategy may be adversely affected by any such economic downturns (including the downturn related to the current\nCOVID-19 pandemic), volatile business environments and continued unstable or unpredictable economic and market conditions. If these conditions\ncontinue to deteriorate or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly,\nand more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse\neffect on our growth strategy, financial performance, and share price and could require us to delay or abandon development or commercialization\nplans.\n\n \n\n**If\nsecurities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our\nstock price and trading volume may decline.**\n\n \n\nThe\ntrading market for our common stock relies in part on the research and reports that industry or financial analysts publish about us,\nour business, our markets and our competitors. We do not control these analysts. If securities analysts do not cover our common stock,\nthe lack of research coverage may adversely affect the market price of our common stock. Furthermore, if one or more of the analysts\nwho do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price\nwould likely decline. If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose\nvisibility in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline\nand may also impair our ability to expand our business with existing customers and attract new customers.\n\n \n\n50\n\n[Table of Contents](#toc_001)\n\n \n\n**Because\ncertain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions\nrequiring stockholder approval.**\n\n \n\nAs\nof May 26, 2026, our directors, executive officers and principal stockholders, and their respective affiliates, beneficially own\napproximately 51% of our outstanding shares of common stock. As a result, these stockholders, acting together, have the ability to control\nthe outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation\nor sale of all or substantially all of our assets. In addition, these stockholders, acting together, have the ability to control the\nmanagement and affairs of our company. Accordingly, this concentration of ownership might harm the market price of our common stock by:\n\n \n\n \n●\ndelaying,\ndeferring or preventing a change in corporate control;\n\n \n \n \n\n \n●\nimpeding\na merger, consolidation, takeover or other business combination involving us; or\n\n \n \n \n\n \n●\ndiscouraging\na potential acquirer from making a tender offer or otherwise attempting to obtain control of us.\n\n \n\n**Future\nsales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could\ncause our share price to fall.**\n\n \n\nWe\nexpect that significant additional capital will be needed in the future to continue our planned operations, including increased marketing,\nhiring new personnel, commercializing our product, and continuing activities as an operating public company. To the extent we raise additional\ncapital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities\nor other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock,\nconvertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.\nSuch sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing\nstockholders.\n\n \n\n**We\ndo not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.**\n\n \n\nWe\ncurrently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate\ndeclaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to the increase,\nif any, of our share price.\n\n \n\n**We\nmay be at risk of securities class action litigation.**\n\n \n\nWe\nmay be at risk of securities class action litigation. In the past, biotechnology and pharmaceutical companies have experienced significant\nstock price volatility, particularly when associated with binary events such as clinical trials and product approvals. If we face such\nlitigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our\nbusiness and results in a decline in the market price of our common stock.\n\n \n\n51\n\n[Table of Contents](#toc_001)\n\n \n\n**Our\ncommon stock is currently listed on The Nasdaq Capital Market. If we are unable to maintain listing of our securities on Nasdaq or any\nstock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could\nbe impaired and it may be more difficult for our stockholders to sell their securities.**\n\n \n\nAlthough\nour common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum\nlisting requirements or those of any other national exchange. If we are unable to maintain listing on Nasdaq or if a liquid market for\nour common stock does not develop or is sustained, our common stock may remain thinly traded.\n\n \n\nThe\nlisting rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange. If, for any\nreason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its\nexchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may\noccur, each of which could have a material adverse effect on our stockholders:\n\n \n\n \n●\nthe\nliquidity of our common stock;\n\n \n \n \n\n \n●\nthe\nmarket price of our common stock;\n\n \n \n \n\n \n●\nour\nability to obtain financing for the continuation of our operations;\n\n \n \n \n\n \n●\nthe\nnumber of institutional and general investors that will consider investing in our common stock;\n\n \n \n \n\n \n●\nthe\nnumber of market makers in our common stock;\n\n \n \n \n\n \n●\nthe\navailability of information concerning the trading prices and volume of our common stock; and\n\n \n \n \n\n \n●\nthe\nnumber of broker-dealers willing to execute trades in shares of our common stock.\n\n \n\n**Our\nsecond amended and restated certificate of incorporation (“Amended and Restated Certificate of Incorporation”) and our second\namended and restated bylaws (the “Amended and Restated Bylaws”) and Delaware law may have anti-takeover effects that could\ndiscourage, delay or prevent a change in control, which may cause our stock price to decline.**\n\n \n\nOur\nAmended and Restated Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law could make it more difficult for\na third party to acquire us, even if closing such a transaction would be beneficial to our stockholders. We are authorized to issue up\nto 10 million shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined\nat the time of issuance by our board of directors without further action by stockholders. The terms of any series of preferred stock\nmay include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion\nand redemption rights and sinking fund provisions. The issuance of any preferred stock could materially adversely affect the rights of\nthe holders of our common stock, and therefore, reduce the value of our common stock. In particular, specific rights granted to future\nholders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve\ncontrol by the present management.\n\n \n\nProvisions\nof our Amended and Restated Certificate of Incorporation and our Amended and Restated Bylaws and Delaware law also could have the effect\nof discouraging potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes\na stockholder might consider favorable. Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove\nour management. In particular, the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:\n\n \n\n \n●\nprovide\nthe board of directors with the ability to alter the Amended and Restated Bylaws without stockholder approval;\n\n \n \n \n\n \n●\nplace\nlimitations on the removal of directors;\n\n \n \n \n\n \n●\nestablish\nadvance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon\nat stockholder meetings; and\n\n \n \n \n\n \n●\nprovide\nthat vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.\n\n \n\n**Financial\nreporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management is required to devote\nsubstantial time to compliance matters.**\n\n \n\nAs\na publicly traded company we incur significant additional legal, accounting and other expenses. The obligations of being a public company\nin the U.S. require significant expenditures and place significant demands on our management and other personnel, including costs resulting\nfrom public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance practices,\nincluding those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing requirements\nof The Nasdaq Capital Market. These rules require the establishment and maintenance of effective disclosure and financial controls and\nprocedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules that\nare often difficult to implement, monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS Act,\nthe reporting requirements, rules, and regulations will make some activities more time-consuming and costly, particularly after we are\nno longer an “emerging growth company.” Our management and other personnel will need to devote a substantial amount of time\nto ensure that we comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance\nand risk becoming subject to litigation or being delisted, among other potential problems.\n\n \n\n52\n\n[Table of Contents](#toc_001)\n\n \n\n**Our\nAmended and Restated Bylaws provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for substantially\nall disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum\nfor disputes with the Company or its directors, officers or employees.**\n\n \n\nOur\nAmended and Restated Bylaws provides that unless we consent in writing to the selection of an alternative forum, the State of Delaware\nis the sole and exclusive forum for: (i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim\nof breach of a fiduciary duty owed by any director, officer or other employee of our Company to us or our stockholders, (iii) any action\nasserting a claim against us, our directors, officers or employees arising pursuant to any provision of the Delaware General Corporation\nLaw (the “DGCL”) or our Amended and Restated Certificate of Incorporation or our Amended and Restated Bylaws, or (iv) any\naction asserting a claim against us, our directors, officers, employees or agents governed by the internal affairs doctrine, except for,\nas to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that there is an indispensable party not\nsubject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the\nCourt of Chancery within ten days following such determination), which is vested in the exclusive jurisdiction of a court or forum other\nthan the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction. This exclusive forum provision\nwould not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or any other claim\nfor which the federal courts have exclusive jurisdiction. To the extent that any such claims may be based upon federal law claims, Section\n27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the\nExchange Act or the rules and regulations thereunder.\n\n \n\nSection\n22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability\ncreated by the Securities Act or the rules and regulations thereunder. However, our Amended and Restated Bylaws contain a federal forum\nprovision which provides that unless we consent in writing to the selection of an alternative forum, the U.S. federal district courts\nwill be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. Any person\nor entity purchasing or otherwise acquiring any interest in shares of our capital stock are deemed to have notice of and consented to\nthis provision.\n\n \n\nThese\nchoice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes\nwith us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and\nother employees. Alternatively, if a court were to find our choice of forum provisions contained in either our Amended and Restated Bylaws\nto be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions,\nwhich could harm our business, results of operations, and financial condition.\n\n \n\n**If\nwe fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately\nreport our financial condition, results of operations or cash flows.**\n\n \n\nThe\nSarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure\ncontrols and procedures. We are required to furnish a report by management on, among other things, the effectiveness of internal control\nover financial reporting. This assessment will include disclosure of any material weaknesses identified by management in our internal\ncontrol over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial\nreporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will\nnot be prevented or detected on a timely basis. Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from an\nissuer’s independent registered public accounting firm on the effectiveness of its internal control over financial reporting. However,\nfor as long as we remain an emerging growth company under the JOBS Act, we may take advantage of the exemption permitting us not to comply\nwith the independent registered public accounting firm attestation requirement.\n\n \n\n53\n\n[Table of Contents](#toc_001)\n\n \n\nOur\ncompliance with Section 404 of the Sarbanes-Oxley Act may require that we incur substantial accounting expense and expend significant\nmanagement efforts. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion. During the\nevaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we may\nbe unable to assert that our internal control over financial reporting is effective. In connection with management’s assessment\nof internal controls over financial reporting for the year ended December 31, 2025 and all prior periods, we identified a material weakness due to inadequate\nsegregation of duties within our accounting processes due to limited personnel and insufficient written policies and procedures for accounting,\nIT and financial reporting and record keeping, lack of accounting system for financial reporting/bookkeeping and software\nfor stock awards, and insufficient policies and procedures for processing and approving employee expense reports. Although we are developing a plan to remediate the material weaknesses, we cannot assure\nyou that we will be able to remediate such weaknesses or that there will not be new material weaknesses or significant deficiencies in\nour internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could\nseverely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude\nthat our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of\nour financial reports, the value of our common stock could decline, and we could be subject to sanctions or investigations by regulatory\nauthorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other\neffective control systems required of public companies, could also restrict our future access to the capital markets."}