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● We will require additional capital in order to continue our operations and may have difficulty raising additional capital.
−Removed: ● We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators, including potential disruptions at our sole source supplier of iopofosine, AtomVie may impede our ability to gain FDA approval and delay or impair commercialization of any products.
+Added: ● Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
+Added: ● We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain FDA approval and delay or impair commercialization of any products.
● We cannot assure the successful development and commercialization of our compounds in development.
● Failure to complete the development of our technologies, obtain government approvals, including required FDA approvals, or comply with ongoing governmental regulations could prevent, delay or limit introduction or sale of proposed products and result in failure to achieve revenues or maintain our ongoing business.
+Added: ● Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.
● The FDA has granted rare pediatric disease designation, RPDD, to iopofosine for treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma;
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● Controls we or our third-party collaborators have in place to ensure compliance with all applicable laws and regulations may not be effective.
+Added: ● We are exposed to product, clinical and preclinical liability risks that could create a substantial financial burden should we be sued.
● We expect to rely on our patents as well as specialized regulatory designations such as orphan drug classification for our product candidates, but regulatory drug designations may not confer marketing exclusivity or other expected commercial benefits.
−Removed: ● Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.
+Added: ● We may face litigation from third parties claiming our products infringe on their intellectual property rights, particularly because there is often substantial uncertainty about the validity and breadth of medical patents.
+Added: ● If we are unable to adequately protect or enforce our rights to intellectual property or to secure rights to third-party patents, we may lose valuable rights, experience reduced market share, assuming any, or incur costly litigation to protect our intellectual property rights.
● We rely on a small number of key personnel who may terminate their employment with us at any time, and our success will depend on our ability to hire additional qualified personnel.
+Added: ● Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.
+Added: ● We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their current or former employers.
● Acceptance of our products in the marketplace is uncertain and failure to achieve market acceptance will prevent or delay our ability to generate revenues.
−Removed: ● Regulatory approval for any approved product is limited by the FDA, the European Commission and other regulators to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may incur significant liability if it is determined that we are promoting the “off-label” use of any of our future product candidates if approved.
−Removed: ● Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow will be diminished, and the capital necessary to fund our operations will be increased.
−Removed: ● The COVID-19 pandemic as well as conflicts, military actions, terrorist attacks, natural disasters.
−Removed: public health crises, cyber-attacks and general instability could materially adversely affect our business.
+Added: ● Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow may be diminished, and the capital necessary to fund our operations may be increased.
+Added: ● If any of our third-party contractors fail to perform their responsibilities to comply with FDA rules and regulations, the marketing and sales of our products could be delayed and we may be subject to enforcement action, which could decrease our revenues.
+Added: ● Unforeseen safety issues could emerge with our products, once approved, that could require us to change the prescribing information to add warnings, limit use of the product, and/or result in litigation.
+Added: Any of these events could have a negative impact on our business.
+Added: ● The market for our proposed products is rapidly changing and competitive, and new therapeutics, drugs and treatments that may be developed by others could impair our ability to develop our business or become competitive.
+Added: ● As a result of continued changes in marketing, sales and distribution, we may be unsuccessful in our efforts to sell our proposed products, develop a direct sales organization, or enter into relationships with third parties.
+Added: ● If we are unable to convince physicians of the benefits of our intended products, we may incur delays or additional expense in our attempt to establish market acceptance.
+Added: ● If our products are unable to obtain adequate reimbursement from third-party payors, or if additional healthcare reform measures are adopted, it could hinder or prevent the commercial success of our product candidates.
+Added: ● Enacted and future legislation may increase the difficulty and cost for us to commercialize our product candidates and may affect the prices we may set.
+Added: ● We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws and other federal and state healthcare laws, and the failure to comply with such laws could result in substantial penalties.
+Added: Our employees, independent contractors, consultants, principal investigators, CROs, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
+Added: ● Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.
● Failure to meet Nasdaq’s continued listing requirements could result in the delisting of our common stock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital.
−Removed: ● Our stock price has experienced price fluctuations.
+Added: ● Our common stock price could be further diluted as the result of the issuance of additional shares of common stock, convertible securities, warrants or options.
+Added: ● Provisions of our certificate of incorporation, by-laws, and Delaware law may make an acquisition of us or a change in our management more difficult.
Risks Related to Capital and Our Operations
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As of December 31, 2024, our consolidated cash balance was approximately $23.3 million.
−Removed: We believe our cash balance as of December 31, 2023, in combination with the funds generated by the warrants exercised by investors in January 2024 (see Note 13 to our audited financial statements in Item 8 of this 10-K) is adequate to fund our basic budgeted operations into the fourth quarter of 2024.
−Removed: During the third quarter ended September 30, 2023, the Company completed a private placement with certain institutional investors expected to result in gross proceeds of up to $102.9 million, including gross proceeds of $24.5 million which the Company received at closing.
−Removed: In January 2024, the Company’s Tranche A warrants were all exercised resulting in gross proceeds of $44.1 million with net proceeds of approximately $42.8 million after deducting estimated offering expenses (see Note 13 to our audited financial statements).
+Added: We believe our cash balance as of December 31, 2024, is adequate to fund our basic budgeted operations into the fourth quarter of 2025.
The Company’s ability to execute its current operating plan depends on its ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transaction or other source of capital.
−Removed: The Company plans to continue actively pursuing financing alternatives, however, there can be no assurance that it will obtain the necessary funding, raising substantial doubt
−Removed: about the Company’s ability to continue as a going concern within one year of the date these financial statements are issued.
+Added: The Company plans to continue actively pursuing financing alternatives, however, there can be no assurance that it will obtain the necessary funding, raising substantial doubt about the Company’s ability to continue as a going concern within one year of the date these financial statements are issued.
The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.
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● whether we are able to maintain our listing on a national exchange;
−Removed: ● uncertainty and economic instability resulting from conflicts, military actions, terrorist attacks, natural disasters, public health crises, including the occurrence of a contagious disease or illness, such as the COVID-19 coronavirus, cyber-attacks and general instability;
+Added: ● uncertainty and economic instability resulting from conflicts, military actions, terrorist attacks, natural disasters, public health crises, including the occurrence of a contagious disease or illness, cyber-attacks and general instability;
● the condition of capital markets and the economy generally, both in the U.S.
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In such an event, our business, prospects, financial condition and results of operations may be adversely affected.
−Removed: The COVID-19 pandemic could materially and adversely affect our business.
−Removed: The COVID-19 pandemic could significantly disrupt our business and may prevent us from conducting business activities because of spread of the disease, or as a result of shutdowns that may be requested or mandated by federal, state and local governmental authorities.
−Removed: Business disruptions have included restrictions on our ability to travel, as well as temporary closures.
−Removed: While we have not yet experienced any significant impacts as a result of the pandemic other than delays in clinical trial enrollment, it is not possible at this time to estimate the ultimate impact that it could have on our business.
−Removed: The continued impacts of COVID-19 including new virus strains and the measures taken by government authorities have created uncertainties and could delay our ongoing clinical studies or the manufacture or shipment of iopofosine for clinical studies.
−Removed: Conflicts, military actions, terrorist attacks, natural disasters.
−Removed: public health crises, including the occurrence of a contagious disease or illness, such as the COVID-19 coronavirus, cyber-attacks and general instability could adversely affect our business.
−Removed: Conflicts, military actions, terrorist attacks, natural disasters, public health crises and cyber-attacks have precipitated economic instability and turmoil in financial markets.
−Removed: Instability and turmoil may result in raw material cost increases.
−Removed: In addition, the long-term effects of climate change on general economic conditions and the pharmaceutical manufacturing and distribution industry in particular are unclear, and changes in the supply, demand or available sources of energy and the regulatory and other costs associated with energy production and delivery may affect the availability or cost of goods and services, including raw materials and other natural resources, necessary to run our businesses.
−Removed: The uncertainty and economic disruption resulting from hostilities, military action, acts of terrorism, natural disasters, public health crises or cyber-attacks may impact our operations or those of our suppliers.
−Removed: Accordingly, any conflict, military action, terrorist attack, natural disasters, public health crises or cyber-attack that impacts us or any of our suppliers, could have a material adverse effect on our business, liquidity, prospects, financial condition and results of operations.
−Removed: War, terrorism, other acts of violence, or natural or manmade disasters may affect the markets in which we operate, our patients and resources required in our research and development activities.
−Removed: Our business may be adversely affected by political instability, disruption or destruction in a geographic region in which we operate, regardless of cause, including war, terrorism, riot, civil insurrection or social unrest, and natural or manmade disasters, including famine, flood, fire, earthquake, storm or pandemic events and spread of disease, such as the COVID-19 pandemic and the significant military action against Ukraine by Russia.
−Removed: Such events may affect our business by increasing prices for resources required in our research and development activities or limiting our access to patients for our clinical trials which may delay our progress on one or more of our clinical or preclinical drug product candidates.
−Removed: Our business and operations may be materially adversely affected in the event of computer system failures or security breaches.
−Removed: Despite the implementation of security measures, our internal computer systems, and those of our third-party manufacturers, contract research organizations and other third parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, phishing attempts, natural disasters, fire, terrorism, war and telecommunication and electrical failures.
−Removed: If such an event were to occur and interrupt our operations, it could result in a material disruption in our business.
−Removed: For example, the loss of clinical study data from ongoing or planned clinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
−Removed: To the extent that any disruption or security breach results in a loss of or damage to our data or applications, loss of trade secrets, inappropriate disclosure of confidential or proprietary information, including protected health information or personal data of employees or former employees, lack of access to our clinical data, or disruption of the manufacturing process, we could incur liability and the further development of our drug candidates could be delayed.
−Removed: We may also be vulnerable to cyber-attacks or other malfeasance by hackers.
−Removed: This type of breach of our cybersecurity may compromise our confidential and financial information, adversely affect our business, or result in legal proceedings.
−Removed: Further, these cybersecurity breaches may inflict reputational harm upon us that may result in decreased market value and erode public trust.
−Removed: Failure to meet investor and stakeholder expectations regarding environmental, social and corporate governance, or “ESG” matters may damage our reputation.
−Removed: There is an increasing focus from certain investors, employees and other stakeholders concerning ESG matters.
−Removed: Additionally, public interest and legislative pressure related to public companies’ ESG practices continue to grow.
−Removed: If our ESG practices fail to meet
−Removed: investor, employee or other stakeholders’ evolving expectations and standards for responsible corporate citizenship in areas including environmental stewardship, Board of Directors and employee diversity, human capital management, corporate governance and transparency, our reputation, brand, appeal to investors and employee retention may be negatively impacted, which could have a material adverse effect on our business or financial condition.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
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Risks Related to Manufacturing and Supply
−Removed: We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators, including potential disruptions at our sole source supplier of iopofosine, AtomVie, may impede our ability to gain FDA approval and delay or impair commercialization of any products.
+Added: We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain FDA approval and delay or impair commercialization of any products.
We are in the preclinical and clinical study phases of product development and commercialization.
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We rely significantly on contracts with third parties to use their facilities to conduct our research, development and manufacturing.
−Removed: We have engaged AtomVie, which has been a validated cGMP manufacturing organization specializing in radiopharmaceuticals, as our exclusive source to supply drug product for our ongoing research and clinical studies, including our Phase 1 and Phase 2 studies of iopofosine.
+Added: We have engaged AtomVie and SpectronRx as sources to supply drug product for our ongoing research and clinical studies.
In addition, we rely exclusively on contract research organizations to conduct research and development.
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This may lead to the stopping or delay of our clinical trials or commercial manufacturing activity.
−Removed: For example, in 2018, our CMO, AtomVie, was placed on import alert following an FDA inspection, which resulted in our studies being placed on a clinical hold, until we received an FDA exception allowing us to import our study drug for use in clinical trials.
−Removed: The import alert on AtomVie was removed in 2019.
Failure of any of these collaborators to provide the required services in a timely manner or on commercially reasonable terms could materially delay the development and approval of our products, increase our expenses, and materially harm our business, prospects, financial condition and results of operations.
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Moreover, we may not be able to transfer processes that are proprietary to the manufacturer, if any.
−Removed: These manufacturers may not be able to produce material on a timely basis or manufacture material at the quality level or in the quantity required to meet our development timelines and applicable regulatory requirements and may also experience a shortage in qualified personnel, including as a result of the impacts of the COVID-19 pandemic.
+Added: These manufacturers may not be able to produce material on a timely basis or manufacture material at the quality level or in the quantity required to meet our development timelines and applicable regulatory requirements and may also experience a shortage in qualified personnel.
We may not be able to maintain or renew our existing third-party manufacturing arrangements, or enter into new arrangements, on acceptable terms, or at all.
−Removed: Our third-party
−Removed: manufacturers could terminate or decline to renew our manufacturing arrangements based on their own business priorities, at a time that is costly or inconvenient for us.
+Added: Our third-party manufacturers could terminate or decline to renew our manufacturing arrangements based on their own business priorities, at a time that is costly or inconvenient for us.
If we are unable to contract for the production of materials in sufficient quantity and of sufficient quality on acceptable terms, our planned clinical trials may be significantly delayed.
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Additionally, if we are required to enter into new supply arrangements, we may not be able to obtain approval from the FDA of any alternate supplier in a timely manner, or at all, which could delay or prevent the clinical development and commercialization of any related product candidates.
−Removed: Failure of our third-party manufacturers or us to comply with applicable regulations, whether because of the impacts of the COVID-19 pandemic or otherwise, could result in sanctions being imposed on us, including fines, civil penalties, delays in or failure to grant marketing approval of our product candidates, injunctions, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products and compounds, operating restrictions and criminal prosecutions, warning or similar letters or civil, criminal or administrative sanctions against the company, any of which could adversely affect our business.
+Added: Failure of our third-party manufacturers or us to comply with applicable regulations could result in sanctions being imposed on us, including fines, civil penalties, delays in or failure to grant marketing approval of our product candidates, injunctions, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products and compounds, operating restrictions and criminal prosecutions, warning or similar letters or civil, criminal or administrative sanctions against the company, any of which could adversely affect our business.
We believe that we have a good working relationship with our third-party collaborators.
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The PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting agents.
−Removed: The PDC platform features include the capacity to link with almost any molecule, the delivery of a significant increase in targeted oncologic payload, and the ability to target all tumor cells.
+Added: The PDC platform features include the capacity to link with almost any molecule, the delivery of a significant increase in targeted oncologic payload, and the ability to target nearly all tumor cells.
As a result, we believe that we can generate PDCs to treat a broad range of cancers with the potential to improve the therapeutic index of oncologic drug payloads, enhance or maintain efficacy while reducing adverse events by minimizing drug delivery to healthy cells, and increase delivery to cancerous cells and cancer stem cells.
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● Even if our cancer-targeting and delivery technologies are shown to be safe and effective for their intended purposes, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities at reasonable prices or at all.
−Removed: ● Our ability to complete the development and commercialization of our cancer-targeting and delivery technologies for their intended use is substantially dependent upon our ability to raise sufficient capital or to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and the manufacturing, marketing and distribution of, our products.
+Added: ● Our ability to complete the development and commercialization of our cancer-targeting and delivery technologies for their intended use is substantially dependent upon our ability to raise sufficient capital or to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, clinical trial patient enrollment in, and the manufacturing, marketing and distribution of, our products.
● Even if our cancer-targeting and delivery technologies are successfully developed, approved by all necessary regulatory authorities, and commercially produced, there is no guarantee that there will be market acceptance of our products.
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Of particular significance to us are the requirements relating to research and development and testing.
−Removed: The activities associated with the
−Removed: research, development and commercialization of iopofosine and other future candidates in our pipeline must undergo extensive clinical trials, which can take many years and require substantial expenditures, subject to extensive regulation by the FDA and other regulatory agencies in the U.S.
+Added: The activities associated with the research, development and commercialization of iopofosine, CLR 121225, CLR 121125, and other future candidates in our pipeline must undergo extensive clinical trials, which can take many years and require substantial expenditures, subject to extensive regulation by the FDA and other regulatory agencies in the U.S.
and by comparable authorities in other countries.
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● the clinical results may not replicate the results of earlier, smaller trials;
−Removed: ● we or third parties with whom we collaborate, may be significantly impacted by the evolving impacts of the ongoing COVID-19 pandemic;
● we, or the FDA or similar foreign regulatory authorities, may delay, terminate or suspend the trials;
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The FDA has substantial discretion in the approval process and may refuse to approve any NDA or sNDA and decide that our data is insufficient for approval and require additional preclinical, clinical or other studies.
−Removed: Varying interpretations of the data obtained
−Removed: from preclinical and clinical testing could delay, limit or prevent regulatory approval of our products for any individual, additional indications.
−Removed: To be commercially viable, we must successfully research, develop, manufacture, introduce, obtain the required regulatory approval described above for, our product candidates, in order to market and distribute our product candidates.
+Added: Varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent regulatory approval of our products for any individual, additional indications.
+Added: To be commercially viable, we must successfully research, develop, manufacture, introduce, and obtain the required regulatory approval described above for, our product candidates, in order to market and distribute our product candidates.
This includes meeting a number of critical developmental milestones, including:
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In addition, delays or rejections may be encountered based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.
−Removed: Failure to comply with applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension of production or injunction, adverse publicity, as well as other regulatory action against our potential products or us.
+Added: Failure to comply with applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties,
+Added: recall or seizure of products, total or partial suspension of production or injunction, adverse publicity, as well as other regulatory action against our potential products or us.
To conduct the clinical studies that are necessary to obtain approval by the FDA to market a product, it is necessary to receive clearance from the FDA to conduct such clinical studies.
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There can be no assurance, however, that we or our collaborative partners will not have to provide additional information or analysis, or conduct additional clinical trials, before receiving approval to market product candidates.
+Added: Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.
+Added: If a product candidate is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical need for this condition, the sponsor may apply for FDA fast track designation.
+Added: Fast track designation applies to the combination of the product and the specific indication for which it is being studied.
+Added: The sponsor of a fast track product has opportunities for more frequent interactions with the review team during product development, and the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.
+Added: However, fast track designation does not change the standards for approval and does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe.
+Added: As a result, while the FDA has granted fast track designation to iopofosine for WM patients having received two or more prior treatment regimens and/or we may seek and receive fast track designation for our future product candidates, we may not experience a faster development process, review or approval compared to conventional FDA procedures.
+Added: In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.
+Added: Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.
The FDA has granted rare pediatric disease designation, RPDD, to iopofosine for treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma;
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It is possible that even if we obtain approval for iopofosine and qualify for a priority review voucher, the program may no longer be in effect at the time of such approval.
+Added: Furthermore, due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine, the Company is, in addition to determining the availability of funding for such a study, pursuing strategic options for the further development and commercialization of this product candidate.
Clinical studies involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.
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The clinical investigators are not our employees, and we cannot control the amount or timing of resources that they devote to our programs.
−Removed: Failure of the third-party organizations to meet their obligations, whether because of the impacts of the ongoing COVID-19 pandemic or otherwise, could adversely affect clinical development of our products.
−Removed: As a result, we may face additional delaying factors outside our control if these parties do not
−Removed: perform their obligations in a timely fashion.
+Added: Failure of the third-party organizations to meet their obligations could adversely affect clinical development of our products.
+Added: As a result, we may face additional delaying factors outside our control if these parties do not perform their obligations in a timely fashion.
For example, any number of those issues could arise with our clinical trials causing a delay.
Delays of this sort could occur for the reasons identified above or other reasons.
−Removed: If we have delays in conducting the clinical trials or obtaining regulatory approvals, our product development costs will increase.
+Added: If we have delays in conducting the clinical trials or obtaining regulatory approvals, our product development costs will
For example, we may need to make additional payments to third-party investigators and organizations to retain their services or we may need to pay recruitment incentives.
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Our clinical studies may not demonstrate sufficient levels of efficacy necessary to obtain the requisite regulatory approvals for our drugs, and our proposed drugs may not be approved for marketing.
−Removed: We may not be able to initiate or continue clinical studies or trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these clinical trials as required by the FDA or other regulatory authorities, whether a result of the impacts of the ongoing COVID-19 pandemic or otherwise.
+Added: We may not be able to initiate or continue clinical studies or trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these clinical trials as required by the FDA or other regulatory authorities.
Even if we are able to enroll a sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs for our product candidates may increase and the completion of our clinical trials may be delayed, or our clinical trials could become too expensive to complete.
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Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in our clinical studies.
+Added: The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including due to judicial challenges.
+Added: On June 28, 2024, the U.S.
+Added: Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act (APA) “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the FDA and other agencies with significant oversight of the biopharmaceutical industry.
+Added: The new framework is likely to increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases.
+Added: As a result, significant regulatory policies will be subject to increased litigation judicial scrutiny.
+Added: Any resulting changes in regulation may result in unexpected delays, increased costs, or other negative impacts on our business that are difficult to predict.
Risks Related to Legal Compliance and Litigation
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The inability of our third-party collaborators to maintain the required licenses and permits for any reason will negatively impact our manufacturing, and research and development activities.
−Removed: In addition, we may be required to indemnify third-party collaborators against certain liabilities arising out of any failure by them to comply with such regulations and/or laws.
+Added: In addition, we may be
+Added: required to indemnify third-party collaborators against certain liabilities arising out of any failure by them to comply with such regulations and/or laws.
If we or our third-party collaborators fail to comply with any of these regulations and/or laws, a range of consequences could result, including the suspension or termination of clinical studies, failure to obtain approval of a product candidate, restrictions on our products or manufacturing processes, withdrawal of our products from the market, significant fines, exclusion from government healthcare programs, or other sanctions or litigation.
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Even though we have received ODD as described above, we may not be the first to obtain marketing approval for the orphan-designated indication because of the uncertainties associated with developing pharmaceutical products.
−Removed: For any product candidate for which we have been or will be granted ODD in a particular indication, it is possible that another company also holding ODD for the
−Removed: same product candidate will receive marketing approval for the same indication before we do.
+Added: For any product candidate for which we have been or will be granted ODD in a particular indication, it is possible that another company also holding ODD for the same product candidate will receive marketing approval for the same indication before we do.
If that were to happen, our applications for that indication may not be approved until the competing company’s period of exclusivity expires.
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We will not be able to rely on it to exclude other companies from manufacturing or selling products using the same principal molecular structural features for the same indication beyond these timeframes without our patent portfolio.
−Removed: Even if we were the first to obtain marketing authorization for an orphan drug indication, there are circumstances under which a competing product may be approved for the same indication during the seven-year period of marketing exclusivity, such as if the later product is shown to be clinically superior to the product with orphan exclusivity.
+Added: Even if we were the first to obtain marketing authorization for an orphan drug indication, there are circumstances under which a competing product may be approved for the same indication during the seven-year period of marketing exclusivity, such as if
+Added: the later product is shown to be clinically superior to the product with orphan exclusivity.
Even after an orphan product is approved, the FDA can subsequently approve the same drug with the same active moiety for the same condition if the FDA concludes that the later drug is safer, more effective, or makes a major contribution to patient care.
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Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug exclusivity and would materially adversely affect our business, results of operations, financial condition and prospects.
−Removed: Fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.
−Removed: If a product candidate is intended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to address unmet medical need for this condition, the sponsor may apply for FDA fast track designation.
−Removed: Fast track designation applies to the combination of the product and the specific indication for which it is being studied.
−Removed: The sponsor of a fast track product has opportunities for more frequent interactions with the review team during product development, and the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.
−Removed: However, fast track designation does not change the standards for approval and does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe.
−Removed: As a result, while the FDA has granted fast track designation to iopofosine for WM patients having received two or more prior treatment regimens and/or we may seek and receive fast track designation for our future product candidates, we may not experience a faster development process, review or approval compared to conventional FDA procedures.
−Removed: In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.
−Removed: Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.
We may face litigation from third parties claiming our products infringe on their intellectual property rights, particularly because there is often substantial uncertainty about the validity and breadth of medical patents.
1 unchanged sentence
This risk is exacerbated by the fact that the validity and breadth of claims covered in medical technology patents, and the breadth and scope of trade-secret protection, involve complex legal and factual questions for which important legal principles are unresolved.
−Removed: Any litigation or claims against us,
−Removed: whether valid or not, could result in substantial costs, place a significant strain on our financial and managerial resources, and harm our reputation.
+Added: Any litigation or claims against us, whether valid or not, could result in substantial costs, place a significant strain on our financial and managerial resources, and harm our reputation.
License agreements that we may enter into in the future would likely require that we pay the costs associated with defending this type of litigation.
10 unchanged sentences
To the extent we license patents from third parties, the early termination of any such license agreement would result in the loss of our rights to use the covered patents, which could severely delay, inhibit or eliminate our ability to develop and commercialize compounds based on the licensed patents.
−Removed: Our competitors may also independently develop products similar to ours or design around or otherwise circumvent patents issued or licensed to us.
+Added: Our competitors may also independently develop products similar to ours or
+Added: design around or otherwise circumvent patents issued or licensed to us.
In addition, the laws of some foreign countries may not protect our proprietary rights to the same extent as U.S.
46 unchanged sentences
● the strength of marketing and distribution support;
−Removed: ● impacts resulting from the evolving effects of the COVID-19 pandemic;
● the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies, if any;
22 unchanged sentences
If the FDA or other regulatory or enforcement authorities determine that our communications regarding our marketed product are not in compliance with the relevant regulatory requirements and that we have improperly promoted off-label uses, or that our communications regarding our investigational products are not in compliance with the relevant regulatory requirements and that we have improperly engaged in pre-approval promotion, we may be subject to significant liability, including civil and administrative remedies as well as criminal sanctions.
−Removed: Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow will be diminished, and the capital necessary to fund our operations will be increased.
+Added: Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow may be diminished, and the capital necessary to fund our operations may be increased.
Any product for which we have obtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, product labeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, the EMA and other comparable international regulatory authorities.
These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, current good manufacturing practices (cGMP) requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians, import and export requirements and recordkeeping.
−Removed: If we or our suppliers encounter manufacturing, quality or compliance difficulties with respect to any of our product candidates, when and if approved, whether because of the impacts of the ongoing COVID-19 pandemic (including as a result of disruptions of global shipping and the transport of products) or otherwise, we may be unable to obtain or maintain regulatory approval or meet commercial demand for such products, which could adversely affect our business, financial conditions, results of operations and growth prospects.
+Added: If we or our suppliers encounter manufacturing, quality or compliance difficulties with respect to any of our product candidates, when and if approved, we may be unable to obtain or maintain regulatory approval or meet commercial demand for such products, which could adversely affect our business, financial conditions, results of operations and growth prospects.
In addition, the FDA often requires post-marketing testing and surveillance to monitor the effects of products.
The FDA, the EMA and other comparable international regulatory agencies may condition approval of our product candidates on the completion of such post-marketing clinical studies.
−Removed: These post-marketing studies may suggest that a product causes undesirable side effects or may present a risk to the patient.
+Added: These post-marketing studies may suggest that a product causes undesirable side effects or may
+Added: present a risk to the patient.
Additionally, the FDA may require a REMS to help ensure that the benefits of the drug outweigh its risks.
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Until such time as our proposed products are further along in the development process, we will not devote any meaningful time and resources to this effort.
−Removed: At the appropriate time, we will determine whether we will develop our own sales and marketing capabilities or enter into agreements with third parties to sell our products.
+Added: appropriate time, we will determine whether we will develop our own sales and marketing capabilities or enter into agreements with third parties to sell our products.
We have limited experience in developing, training or managing a sales force.
30 unchanged sentences
In the U.S., no uniform policy of coverage and reimbursement for products exists among third-party payors;
−Removed: therefore, coverage and reimbursement levels for products can differ significantly from payor to payor.
+Added: therefore, coverage and reimbursement
+Added: levels for products can differ significantly from payor to payor.
As a result, the coverage determination process is often a time consuming and costly process that may require us to provide scientific, clinical or other support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.
5 unchanged sentences
The Tax Cuts and Jobs Act of 2017 included a provision that repealed the tax-based shared responsibility payment imposed by the Affordable Care Act on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”.
−Removed: In addition, the Further the Consolidated Appropriations Act of 2020 fully repealed the Affordable Care Act’s mandated “Cadillac” tax on high-cost employer-sponsored health coverage and medical device tax and also eliminated the health insurer tax.
+Added: In addition, the Consolidated Appropriations Act of 2020 fully repealed the Affordable Care Act’s mandated “Cadillac” tax on high-cost employer-sponsored health coverage and medical device tax and also eliminated the health insurer tax.
On June 17, 2021, the U.S.
5 unchanged sentences
A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.
−Removed: This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013, and, a result of subsequent legislative amendments, will remain in effect into 2031, unless additional Congressional action is
+Added: This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect in April 2013, and, a result of subsequent legislative amendments, will remain in effect into 2031, unless additional Congressional action is taken.
However, COVID-19 relief support legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2022 with a subsequent reduction to 1% implemented from April 1, 2022 until June 30, 2022.
27 unchanged sentences
comply with federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the US and similar foreign fraudulent misconduct laws;
−Removed: or report financial information or data accurately or to disclose unauthorized
−Removed: activities to us.
+Added: or report financial information or data accurately or to disclose unauthorized activities to us.
It is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
4 unchanged sentences
Risks Related to Internal Controls
+Added: We identified certain misstatements to our previously issued financial statements and have restated the financial statements described below, which has exposed us to additional risks and uncertainties.
+Added: We have restated our previously issued audited financial statements as of and for the years ended December 31, 2022 and 2023 and our interim financial statements as of and for the quarterly periods ended March 31, 2023 through September 30, 2023 and March 31, 2022 through September 30, 2022.
+Added: As a result of the misstatements discussed and the Restatement, we have become subject to a number of additional risks and uncertainties and unanticipated costs for accounting, legal and other fees and expenses, including risks of lawsuit relating to securities offered by us in public and private offerings as well as claims by purchasers of our shares of common stock in the public market.
+Added: actions, lawsuits or other legal proceedings related to the misstatements or the Restatement could result in liabilities, reputational harm and defense and other costs, regardless of the outcome of the lawsuit or proceeding.
+Added: We cannot ensure that litigation or other claims by stockholders will not be brought in the future arising out of the Restatement.
+Added: We may also be subject to further examinations, investigations, proceedings and orders by regulatory authorities as a result of the Restatement.
+Added: Any such further actions could be expensive and damaging to our business, results of operations and financial condition.
Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.
10 unchanged sentences
Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reporting or disclosure of management’s assessment of our internal controls over financial reporting our business and results of operations could be harmed, we could fail to meet our reporting obligations, and there could be a material adverse effect on our common stock price.
−Removed: In 2023, three material weaknesses have been identified that are described further in Item 9A.
+Added: There are identified material weaknesses that are described further in Item 9A.
+Added: These material weaknesses resulted in our historical financial statements requiring restatement, as is noted above, and delayed our required filings with the SEC, a situation that could recur in the event that we do not effectively remediate the existing material weaknesses and/or experience additional material weaknesses.
Risks Related to Our Equity Securities
Failure to meet Nasdaq’s continued listing requirements could result in the delisting of our common stock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital.
−Removed: If our common stock becomes subject to delisting, it would be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities.The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common stock.
+Added: We must continue to satisfy Nasdaq continued listing requirements, including, among other things, certain corporate governance requirements and a minimum closing bid price requirement of $1.00 per share.
+Added: If a company fails for 30 consecutive business days to meet the $1.00 minimum closing bid price requirement, Nasdaq will send a deficiency notice to the company, advising that it has been afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements.
+Added: On January 30, 2025, we received a deficiency letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on Nasdaq pursuant to the minimum closing bid price requirement.
+Added: The Nasdaq deficiency letter had no immediate effect on the listing of our common stock.
+Added: In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been given 180 calendar days, or until July 29, 2025, to regain compliance with the minimum closing bid price requirement by causing our stock to close above $1.00 for a minimum of 10 consecutive trading days.
+Added: If we do not regain compliance with the minimum closing bid price requirement by July 29, 2025, we may be afforded a second 180 calendar day period to regain compliance.
+Added: To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except for the minimum bid price requirement.
+Added: In addition, we would be required to notify Nasdaq of our intent to cure the deficiency during the second compliance period.
+Added: If our common stock becomes subject to delisting, it would be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities.
+Added: The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common stock.
This would adversely affect the ability of investors to trade our common stock and would adversely affect the value of our common stock.
1 unchanged sentence
If we seek to implement a further reverse stock split in order to remain listed on Nasdaq, the announcement or implementation of such a reverse stock split could negatively affect the price of our common stock.
−Removed: Our stock price has experienced price fluctuations.
+Added: Our stock price has experienced, and may continue to experience, price fluctuations.
+Added: Our stock price has been and continues to be highly volatile.
There can be no assurance that the market price for our common stock will remain at its current level, and a decrease in the market price could result in substantial losses for investors.
23 unchanged sentences
In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which may, unless certain criteria are met, prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from merging or combining with us for a prescribed period of time.
+Added: General Risk Factors
+Added: Conflicts, military actions, terrorist attacks, natural disasters.
+Added: public health crises, including the occurrence of a contagious disease or illness, cyber-attacks and general instability could adversely affect our business.
+Added: Conflicts, military actions, terrorist attacks, natural disasters, public health crises and cyber-attacks have precipitated economic instability and turmoil in financial markets.
+Added: Instability and turmoil may result in raw material cost increases.
+Added: In addition, the long-term effects of climate change on general economic conditions and the pharmaceutical manufacturing and distribution industry in particular are unclear, and changes in the supply, demand or available sources of energy and the regulatory and other costs associated with energy production and delivery may affect the availability or cost of goods and services, including raw materials and other natural resources, necessary to run our businesses.
+Added: The uncertainty and economic disruption resulting from hostilities, military action, acts of terrorism, natural disasters, public health crises or cyber-attacks may impact our operations or those of our suppliers.
+Added: Accordingly, any conflict, military action, terrorist attack, natural disasters, public health crises or cyber-attack that impacts us or any of our suppliers, could have a material adverse effect on our business, liquidity, prospects, financial condition and results of operations.
+Added: War, terrorism, other acts of violence, or natural or manmade disasters may affect the markets in which we operate, our patients and resources required in our research and development activities.
+Added: Our business may be adversely affected by political instability, disruption or destruction in a geographic region in which we operate, regardless of cause, including war, terrorism, riot, civil insurrection or social unrest, and natural or manmade disasters, including famine, flood, fire, earthquake, storm or pandemic events and spread of disease and the significant military action against Ukraine by Russia.
+Added: Such events may affect our business by increasing prices for resources required in our research and development activities or limiting our access to patients for our clinical trials which may delay our progress on one or more of our clinical or preclinical drug product candidates.
+Added: Our business and operations may be materially adversely affected in the event of computer system failures or security breaches.
+Added: Despite the implementation of security measures, our internal computer systems, and those of our third-party manufacturers, contract research organizations and other third parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, phishing attempts, natural disasters, fire, terrorism, war and telecommunication and electrical failures.
+Added: If such an event were to occur and interrupt our operations, it could result in a material disruption in our business.
+Added: For example, the loss of clinical study data from ongoing or planned clinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
+Added: To the extent that any disruption or security breach results in a loss of or damage to our data or applications, loss of trade secrets, inappropriate disclosure of confidential or proprietary information, including protected health information or personal data of employees or former employees, lack of access to our clinical data, or disruption of the manufacturing process, we could incur liability and the further development of our drug candidates could be delayed.
+Added: We may also be vulnerable to cyber-attacks or other malfeasance by hackers.
+Added: This type of breach of our cybersecurity may compromise our confidential and financial information, adversely affect our business, or result in legal proceedings.
+Added: Further, these cybersecurity breaches may inflict reputational harm upon us that may result in decreased market value and erode public trust.
+Added: Failure to meet investor and stakeholder expectations regarding environmental, social and corporate governance, or “ESG” matters may damage our reputation.
+Added: There is an increasing focus from certain investors, employees and other stakeholders concerning ESG matters.
+Added: Additionally, public interest and legislative pressure related to public companies’ ESG practices continue to grow.
+Added: If our ESG practices fail to meet investor, employee or other stakeholders’ evolving expectations and standards for responsible corporate citizenship in areas including environmental stewardship, Board of Directors and employee diversity, human capital management, corporate governance and transparency, our reputation, brand, appeal to investors and employee retention may be negatively impacted, which could have a material adverse effect on our business or financial condition.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.