COCP

The following is a summary of the principal risk factors we face: ● we have had a history of losses and may not generate sustained positive cash flow sufficient to fund our operations and research and development programs; ● there is substantial doubt about our ability to continue as a going concern; ● our need for, and ability to obtain, additional financing when needed on favorable terms, or at all; ● delays or complications in conducting clinical trials, including our Phase 2a study for oral CC-42344 for our Influenza program which we determined must be redone due to an insufficient infection rate; ● other challenges we face in furthering our research and development efforts, including advancing our product candidates in clinical studies and effectively procuring and working with third party collaborators and regulators in the furtherance thereof; ● risks related to our development efforts, including the risk that clinical studies may not yield favorable results, or that earlier clinical results of effectiveness and safety may not be adequate, reproducible or indicative of future results; ● the risks inherent in developing, obtaining regulatory approvals for and commercializing new, commercially viable and competitive products and treatments, including evolving regulatory requirements, public health recommendations and market acceptance; ● our research and development activities may not result in commercially viable products; ● our ability to manage our growth and our expanded operations; ● the performance of our third-party distribution partners, licensees and manufacturers over which we have limited control, including the ability of our CROs to recruit volunteers for clinical studies; ● changes in regulation and policies in the U.S. and other countries, including a reduction in government spending on healthcare and potential delays within government agencies such as the FDA which may result from ongoing efforts to reduce the size of the federal government and spending by the Trump Administration; ● increased competition, including the possibility that competitors may develop effective and/or less costly treatments or vaccines, including as part of programs financed by the U.S. government; ● our success is dependent on the involvement and continued efforts of our Chairman and Co-Chief Executive Officers; ● the information technology systems that we rely on may be subject to unauthorized tampering, cyberattack or other data security or privacy incidents that could impact our billing processes or disrupt our operations; ● failure to maintain the security of patient-related information; ● our ability to obtain and maintain intellectual property protection for our products; ● our ability to defend our intellectual property rights with respect to our products; ● our ability to operate our business without infringing the intellectual property rights of others; ● our ability to attract and retain key scientific and management personnel; ● failure to obtain and maintain regulatory approval for our products and services; ● legal, economic, political, regulatory, currency exchange, and other risks associated with international operations; ● the possibility of a recession or other adverse consequences in the U.S. or other countries which could result from external factors such as Federal Reserve interest rates, the imposition of tariffs and the possibility of trade wars, increases in unemployment rates, wars and geopolitical conflicts and other ongoing or future events which could adversely impact our ability to access capital on favorable terms or at all and further our research and development efforts; and ● disruptions to operations, including impact on employees, vendors, facilities or technology, or on the industry or economy, from uncontrollable events such as geopolitical conflicts.
We do not have sufficient working capital and cash flows for continued operations for at least the next 12 months.
As a result, management has concluded, and our independent registered public accounting firm has agreed with our conclusion that there is substantial doubt regarding our ability to continue as a going concern for a period of at least 12 months beyond the filing of this Annual Report on Form 10-K.
We had an accumulated deficit of $342.2 million from inception through December 31, 2025 and expect to continue losing money in the future.
As a result, we have accumulated losses of $342.2 million from inception through December 31, 2025, expect losses to continue, and have never generated revenue from product sales.
For example, see the risk factor below entitled “We face significant risks and uncertainties surrounding our Influenza A program following an initial Phase 2a study which failed to yield scientifically viable results relating to the product candidate’s efficacy.” These and other challenges or events that may arise in the future with respect to our research and development efforts could materially adversely effect our operations and financial position, cause reputational harm or damage our relationships with key or prospective collaborators or have other adverse consequences on us and our business.
We face significant risks and uncertainties surrounding our Influenza A program following an initial Phase 2a study which failed to yield scientifically viable results relating to the product candidate’s efficacy.
In December 2024, the Company’s management determined that a Phase 2a study conducted for the Company’s CC-42344 Influenza A product candidate exhibited an inadequately low infectivity rate among participants which hindered antiviral data analysis.
Ultimately management has determined that a new Phase 2a study would be necessary to further pursue research and development of this product candidate.
A dispute has arisen with the CRO that performed the study, in which the Company contends that the CRO breached its agreement in a number of respects and is requesting that the CRO refund the $6,309,000 it was paid or redo the study.
The CRO has implicitly denied liability and is seeking to recover an additional approximately $600,000 from the Company.
As of the date of this Report, it appears that the Company will seek to arbitrate the dispute as required under the agreement with the CRO.
This development has resulted in considerable delays in the development of our Influenza A program.
While we cannot predict the ultimate outcome of these developments, we expect that we will need to conduct a new trial and obtain data that can be used to continue our development of our CC-42344 Influenza A candidate, which development has and will continue to be delayed as a result.
Further, our investments in the initial Phase 2a trial process, including the $6,309,000 million we already paid the CRO, could prove to be all or partially lost as a result.
For example, we may be unable to recoup all or a significant portion of the amounts we previously paid the CRO.
Even if the CRO agrees to conduct a new study at no or a reduced cost, we will still have been delayed in our efforts with respect to the product candidate, and have incurred and will likely continue to incur additional expenses in excess of what were originally incurred and contemplated, as a result of these events, and similar or other issues could arise with any subsequent study or continuance.
Further, if we are unable to reach a favorable resolution with the CRO, we would need to raise capital to fund a new study.
These developments have created significant risks and uncertainties with respect to CC-42344’s use for Influenza A.
For example, in the past certain of our CROs experienced staffing shortages and other issues due to the outbreak of Omicron variant cases of COVID-19, resulting in delays and increased costs in researching our product candidates.
Our reliance on third-party manufacturers to develop products and our anticipated reliance on third-party manufacturers to produce products we may develop in the future entail risks to which we would not be subject if we supplied the materials needed to develop and manufacture our product candidates ourselves, including: ● supply chain shortages including as may be caused by ongoing wars or geopolitical conflicts; ● the inability to meet any product specifications and quality requirements consistently; ● a delay or inability to procure or expand sufficient manufacturing capacity; ● discontinuation or recall of reagents, test kits, instruments, and other items used by us in the development, testing, and potential commercialization of products; ● manufacturing and product quality issues related to scale-up of manufacturing; ● costs and validation of new equipment and facilities required for scale-up; ● a failure to comply with cGMP and similar foreign standards; ● the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; ● the possibility of breach or termination or nonrenewal of manufacturing agreements with third parties in a manner that is costly or damaging to us; ● the reliance on a few sources, and sometimes, single sources for raw materials, such that if we cannot secure a sufficient supply of these product components, we cannot manufacture and sell product candidates in a timely fashion, in sufficient quantities or under acceptable terms; ● the lack of qualified backup suppliers for any raw materials currently purchased from a single source supplier; ● operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; ● carrier disruptions or increased costs beyond our control; ● misappropriation of our proprietary technology for the purpose of manufacturing a “generic” version of our product or sale of our product to organizations that distribute and sell counterfeit goods, including drugs; and ● failing to deliver products under specified storage conditions and in a timely manner.
Some of these events could be the basis for regulatory actions or litigation, including injunction, recall, seizure or total or partial suspension of production.
An alternative vendor would need to be qualified through a New Drug Application (“NDA”) or marketing authorization supplement, which could cause further delay or increased costs.
Any performance failure by our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue or incur losses.
Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals, which is a lengthy and uncertain process .
To date, we have only entered a limited number of compounds into human clinical trials.
If the FDA takes these measures, we may be forced to disclose proprietary information about our product candidates and research, which could materially harm our business.
For example, in June 2022 member countries of the World Trade Organization (“WTO”) agreed to implement a multi-jurisdictional five-year waiver of patent protection with respect to vaccines that target COVID-19 in an effort to fight the pandemic and allow for a more equal distribution of resources towards that goal.
Future actions such as the WTO waiver may be taken by the U.S. or foreign governments with respect to products in which we are or may become involved could materially diminish or eliminate our ability to protect the underlying intellectual property rights we rely on for such products, including those licensed from third parties, and as a result any potential competitive advantage would be lost.
We will not achieve our business plan if the acceptance of our products is inhibited by price competition, coverage limitations by third party healthcare payors, or the reluctance of physicians to switch from existing drug products to our products, or if physicians switch to other new drug products or reserve our products for use in limited circumstances.
Cybersecurity threats in particular, are persistent, evolve quickly and include, but are not limited to, computer viruses, attempts to access information, denial of service and other electronic security.
While we breaches believe that we have implemented appropriate measures and controls and invested in skilled information technology resources to appropriately identify threats and mitigate potential risks, there can be no assurance that such actions will be sufficient to prevent disruptions to critical systems, the unauthorized release of confidential information or corruption of data.
Any or all of the foregoing could have a material negative impact on our business, financial condition and prospects.
Any such events could cause us to lose opportunities or progress with respect to product candidates or strategic alliances, and could require us to incur significant resources and expense to remediate.
In January 2026, the European Medicines Agency and FDA jointly established new artificial intelligence (“AI”) principles in drug development that provide broad guidance on AI use in evidence generation and monitoring across all phases of a medicine’s lifecycle - from early research and clinical trials to manufacturing and drug safety.
These AI principles may lead to future regulatory guidance and requirements in various jurisdictions, which could affect the use of AI in our business.
Congress enacted the One Big Beautiful Bill (“OBBB”) Act, which made several changes to the Medicaid program, such as imposing Medicaid work requirements and imposing stricter eligibility and enrollment standards.
Most of these policies will take effect in 2027.
In addition, the OBBB Act did not extend the availability of enhanced premium subsidies, which subsidize patient premiums for Affordable Care Act (“ACA”) health insurance exchange plans and expired at the end of 2025.
If these subsidies are not reinstated, it is possible that patient enrollment in ACA exchange plans could substantially decrease.

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Gone since FY2024

The following is a summary of the principal risk factors we face: ● our financial statements are qualified on a going concern basis; ● we have had a history of losses and may not generate sustained positive cash flow sufficient to fund our operations and research and development programs; ● our need for, and ability to obtain, additional financing when needed on favorable terms, or at all; ● delays or complications in conducting clinical trials, such as our Phase 2a study for oral CC-42344 for our Influenza program which in late 2024 we determined must be extended due to an insufficient infection rate; ● other challenges we face in furthering our research and development efforts, including advancing our product candidates in clinical studies and effectively procuring and working with third party collaborators and regulators in the furtherance thereof; ● risks related to our development efforts, including the risk that clinical studies may not yield favorable results, or that earlier clinical results of effectiveness and safety may not be adequate, reproducible or indicative of future results; ● the risks inherent in developing, obtaining regulatory approvals for and commercializing new, commercially viable and competitive products and treatments; ● our research and development activities may not result in commercially viable products; ● our ability to manage our growth and our expanded operations; ● the performance of our third-party distribution partners, licensees and manufacturers over which we have limited control, including the ability of our CROs to recruit volunteers for clinical studies; ● changes in regulation and policies in the U.S. and other countries, including a reduction on government spending on healthcare in the wake of the recent election in the U.S. and potential delays within government agencies such as the FDA which may result from efforts to reduce the size of the federal government and spending by the Trump Administration; ● increased competition, including the possibility that competitors may develop effective and/or less costly treatments or vaccines, including as part of the programs financed by the U.S. government; ● our success is dependent on the involvement and continued efforts of our Chairman and Co-Chief Executive Officers; ● the information technology systems that we rely on may be subject to unauthorized tampering, cyberattack or other data security or privacy incidents that could impact our billing processes or disrupt our operations; ● failure to maintain the security of patient-related information; ● our ability to obtain and maintain intellectual property protection for our products; ● our ability to defend our intellectual property rights with respect to our products; ● our ability to operate our business without infringing the intellectual property rights of others; ● our ability to attract and retain key scientific and management personnel; ● failure to obtain and maintain regulatory approval for our products and services; ● legal, economic, political, regulatory, currency exchange, and other risks associated with international operations; ● the possibility of a recession or other adverse consequences in the U.S. or other countries which could result from external factors such as Federal Reserve interest rates, the imposition of tariffs and the possibility of trade wars, increases in unemployment rates, geopolitical conflict and other ongoing or future events which could adversely impact our ability to access capital on favorable terms or at all and further our research and development efforts; and ● disruptions to operations, including impact on employees, vendors, facilities or technology, or on the industry or economy, from uncontrollable events such as geopolitical conflicts.
We do not have sufficient working capital and cash flows for continued operations for at least the next 12 months, which raises a risk of our potential inability to continue as a going concern.
We had an accumulated deficit of $333,418,000 from inception through December 31, 2024 and expect to continue losing money in the future.
As a result, we have accumulated losses of $333,418,000 from inception through December 31, 2024, expect losses to continue, and have never generated revenue from product sales.
For example, in December 2024, the Company announced plans to extend enrollment for the oral CDI-42344 Phase 2a study due to unexpectedly low influenza infection among study participants.
Specifically, management determined that the low infectivity obtained in this study hindered antiviral data analysis.
The Company is currently in continuing discussions with the CRO to address this study and determine a course forward with respect thereto, including potentially by preparing a protocol amendment for approval by the United Kingdom MHRA in order to seek to extend enrollment in this study and to ensure necessary infection rates among enrolled study subjects in the study.
While we cannot predict the ultimate outcome of these developments, we expect that we will need to incur additional expenses to proceed with trial and obtain data that can be used to continue our development of our CDI-42344 Influenza candidate, which development will also be delayed as a result.
Further, our investments in the initial Phase 2s trial process could prove to be all or partially lost as a result.
These and other challenges or events that may arise in the future with respect to our research and development efforts could materially adversely effect our operations and financial position, cause reputational harm or damage our relationships with key or prospective collaborators or have other adverse consequences on us and our business.
For example, beginning in 2021, certain of our CROs began experiencing staffing shortages and other issues due to the outbreak of Omicron cases, resulting in delays and increased costs in researching our product candidates.
Our reliance on third-party manufacturers to develop products and our anticipated reliance on third-party manufacturers to produce products we may develop in the future entail risks to which we would not be subject if we supplied the materials needed to develop and manufacture our product candidates ourselves, including: ● supply chain shortages which were prevalent during the COVID-19 pandemic; ● the inability to meet any product specifications and quality requirements consistently; ● a delay or inability to procure or expand sufficient manufacturing capacity; ● discontinuation or recall of reagents, test kits, instruments, and other items used by us in the development, testing, and potential commercialization of products; ● manufacturing and product quality issues related to scale-up of manufacturing; ● costs and validation of new equipment and facilities required for scale-up; ● a failure to comply with cGMP and similar foreign standards; ● the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; ● the possibility of breach or termination or nonrenewal of manufacturing agreements with third parties in a manner that is costly or damaging to us; ● the reliance on a few sources, and sometimes, single sources for raw materials, such that if we cannot secure a sufficient supply of these product components, we cannot manufacture and sell product candidates in a timely fashion, in sufficient quantities or under acceptable terms; ● the lack of qualified backup suppliers for any raw materials currently purchased from a single source supplier; ● operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; ● carrier disruptions or increased costs beyond our control; ● misappropriation of our proprietary technology for the purpose of manufacturing a “generic” version of our product or sale of our product to organizations that distribute and sell counterfeit goods, including drugs; and ● failing to deliver products under specified storage conditions and in a timely manner.
Some of these events could be the basis for regulatory actions, including injunction, recall, seizure or total or partial suspension of production.
An alternative vendor would need to be qualified through a New Drug Application (“NDA”) or marketing authorization supplement, which could cause further delay.
Any performance failure by our distributors could delay clinical development or marketing approval of our product candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue.
Because our future commercial success depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals .
To date, we have only entered a limited number of compounds into human clinical trials, including our influenza A product candidate to a Phase 2a trial and our norovirus / coronaviruses product candidate to a Phase 1 trial.
If the FDA takes these measures, we may be forced to disclose propriety information about our product candidates and research, which could materially harm our business.
For example, in June 2022 member countries of the World Trade Organization (“WTO”) agreed to implement a multi-jurisdictional five-year waiver of patent protection with respect to vaccines that target COVID-19 in an effort to fight the pandemic and allow for a more equal distribution of resources, particularly for developing countries, towards that goal.
This resulted from ongoing discussions among WTO member countries which began in 2020 with a proposal for a more extensive waiver that would have covered patents for COVID-19 related diagnostics and therapeutics as well as vaccines.
The WTO waiver, together with similar actions that may be taken with respect to COVID-19-related products or other products in which we are or may become involved could materially diminish or eliminate our ability to protect the underlying intellectual property rights we rely on for such products, including those licensed from third parties, and as a result any potential competitive advantage would be lost.
We will not achieve our business plan if the acceptance of our products is inhibited by price competition or the reluctance of physicians to switch from existing drug products to our products, or if physicians switch to other new drug products or reserve our products for use in limited circumstances.
Cybersecurity threats in particular, are persistent, evolve quickly and include, but are not limited to, computer viruses, attempts to access information, denial of service and other electronic security breaches believe that we have implemented appropriate measures and controls and invested in skilled information technology resources to appropriately identify threats and mitigate potential risks, but there can be no assurance that such actions will be sufficient to prevent disruptions to critical systems, the unauthorized release of confidential information or corruption of data.
Any or all of the foregoing could have a material negative impact on its business, financial condition and prospects.
Any such events could cause us to lose opportunities or progress with respect to product candidates or strategic alliances, and could require us to incur significant expense to remediate.
Due to the recent change in presidential administration in the U.S., we and our industry face uncertainty including the potential for reduced government funding of research programs and staff and resource reductions at the FDA and other government agencies, which may adversely affect our business.
As part of this initiative, President Trump established the Department of Government Efficiency (“DOGE”), which is tasked with reducing government spending and increasing efficiency of the federal government and its component agencies.
Since its establishment, DOGE has taken action aimed at reducing the workforce of the federal government and eliminating other expenditures, such as facility leases, used by the federal government and its component agencies.
While these and other actions taken by the Trump Administration could be viewed as a part of a larger goal of de-regulation, a consequence of these developments and other actions taken by DOGE or the Trump Administration generally could be reduced resources, employees and contractors at the FDA and other federal agencies on which our operations depend or through which regulatory approvals are or will be required for us and our product candidates and programs.
We expect we will be subject to additional risks related to entering into international business relationships, including: ● different regulatory requirements for drug approvals in foreign countries; ● reduced protection for intellectual property rights; ● unexpected changes in tariffs, trade barriers and regulatory requirements; ● economic weakness, including inflation, or political instability in foreign economies and markets; ● compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; ● foreign taxes, including withholding of payroll taxes; ● foreign currency fluctuations, which could cause increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; ● workforce uncertainty in countries where labor unrest is endemic; ● the impact of any war or hostilities such as the Russian invasion of Ukraine; ● production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and ● business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
As of March 14, 2025, we have 11 full-time employees.
As our Company matures, we expect to expand our employee base to increase our managerial, scientific and operational, commercial, financial and other resources and to hire more consultants and contractors.
If our management cannot effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy.
The laws that may affect our ability to operate include: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment may be made under a federal healthcare program, such as the Medicare and Medicaid programs; ● federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent; ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and ● state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.
If our operations are found to violate any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, civil and criminal penalties, damages, fines, possible exclusion from Medicare, Medicaid and other government healthcare programs, and curtailment or restructuring of our operations, which could adversely affect our ability to operate our business and our results of operations.
In addition, we rely on Australian CROs for our coronaviruses and norovirus programs, and our Influenza A program will continue to depend on one or more CROs in the United Kingdom for its Phase 2a study for the furtherance of our research and development efforts as to that product.
Our common stock may continue to be volatile and could materially fall for a number of reasons including: ● Announcements by the FDA of final approval of vaccines and treatments for diseases we target; ● Announcements relating to the spread of new variants of diseases we target; ● Announcements by competitors that they are initiating human trials of drugs to treat the diseases we target; ● Events which demonstrate that the spread or intensity of diseases has receded; ● Our disclosure that the use of our technology and the patents we licensed do not appear promising for the treatment of this virus; ● The results of or developments with respect to our clinical trials; ● Our announcement concerning the initiation of or delay in our planned clinical trials; or ● The occurrence of any other events or factors which may have created the unusual volatility and spike in volume.
Factors that could cause fluctuations in the market price of our common stock include the following: ● price and volume fluctuations in the overall stock market from time-to-time; ● due to external factors such as geopolitical turmoil, a possible recession, inflation or other events, including the conflicts in Ukraine and Israel or other unknown hostilities, investors may sell our common stock to meet margin calls on other stocks or as the result of economic disruptions; ● volatility in the market prices and trading volumes of biotechnology stocks generally, or those in our peer group in particular; ● changes in operating performance and stock market valuations of other biotechnology companies generally, or those in our industry in particular; ● sales of shares of our stock by us or our stockholders; ● the failure of securities analysts to maintain coverage of us, changes in financial estimates by securities analysts who follow our company or our failure to meet these estimates or the expectations of investors; ● Announcement of a future reverse split or our failure to obtain stockholder approval for a reverse split; ● announcements by us or our competitors of new novel medicines; ● the public’s reaction to our earnings releases, other public announcements and filings with the SEC; ● rumors and market speculation involving us or other companies in our industry; ● actual or anticipated developments in our business, our competitors’ businesses or the competitive landscape generally; ● actual or anticipated changes in our operating results or fluctuations in our operating results; ● developments or disputes concerning our intellectual property or other proprietary rights; ● new laws or regulations or new interpretations of existing laws or regulations applicable to our business; ● changes in accounting standards, policies, guidelines, interpretations or principles; and ● any significant change in our management.
Because of central bank actions to combat inflation, the imposition and threat of tariffs and geopolitical conflicts, and other major events, the effect on the capital markets and the economy is uncertain, and we may have to deal with a recessionary economy and economic uncertainty including possible material adverse effects upon our business.
Following President Trump’s inauguration in January 2025, certain trends and events have begun to unfold which appear to be affecting the global and United States capital markets and economies, including the continued high central bank interest rates, the imposition and threat of tariffs, trade wars among nations and ongoing geopolitical conflicts, and uncertain capital markets with significant declines in leading market indexes in March 2025.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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