ITEM 1A. RISK FACTORS
Our business, financial condition, operating results
and prospects are subject to the following risks. Additional risks and uncertainties not presently foreseeable to us may also impair our
business operations. If any of the following risks or the risks described elsewhere in this report actually occurs, our business, financial
condition or operating results could be materially adversely affected. In such case, the trading price of our common stock could decline,
and our stockholders may lose all or part of their investment in the shares of our common stock.
This Form 10-K contains forward-looking statements
that involve risks and uncertainties. These statements can be identified by the use of forward-looking terminology such as “believes,”
“expects,” “intends,” “plans,” “may,” “will,” “should,” “predict”
or “anticipation” or the negative thereof or other variations thereon or comparable terminology. Actual results could differ
materially from those discussed in the forward-looking statements as a result of certain factors, including those set forth below and
elsewhere in this Form 10-K.
Summary of Risk Factors
Our business is subject to numerous risks and
uncertainties that you should consider before investing in our common stock. Some of the principal risk factors that make an investment
in the Company speculative or risky are summarized as follows:
· The Company has no sales or marketing personnel.
· There exist conflicts of interest among officers, directors and stockholders.
· Risks relating to dependence on U.S. government contracts.
· Company common stock may be considered “penny stock”.
These and other material risks we face are described more fully herein
which investors should carefully review prior to making an investment decision with respect to the Company or its securities,
Risk Related to the COVID-19 Pandemic
The recent COVID-19 pandemic may adversely affect our business,
and ability to file timely and accurate financial information.
While the complete impact
on our business from the recent outbreak of the COVID-19 coronavirus is unknown at this time and difficult to predict, various aspects
of our business are being adversely affected by it and may continue to be adversely affected.
COVID-19 has been declared
a pandemic by the World Health Organization, has been declared a National Emergency by the United States Government and has resulted in
several states being designated disaster zones. COVID-19 coronavirus caused significant volatility in global markets, including the market
price of our securities. The spread of COVID-19 coronavirus has caused public health officials to recommend precautions to mitigate the
spread of the virus, especially as to travel and congregating in large numbers. In addition, certain states and municipalities have enacted,
and additional cities are considering, quarantining and "shelter-in-place" regulations which severely limit the ability of people
to move and travel, and require non-essential businesses and organizations to close.
Thus far, these restrictions
have adversely affected our results of operations and financial condition. A significant portion of our business, financial and governance
operations are contracted with certain independent contractors and third-parties currently subject to “lock-down” orders or
“shelter in place” recommendations related to the national health crisis created by the COVID-19 pandemic, including key people
responsible for assisting us in the preparation of our financial statements.
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Risks Specific to Our Business
Our company is a development stage company
that has no products approved for commercial sale, never generated any revenues and may never achieve revenues or profitability.
Our company is a development
stage company that has no products approved for commercial sale, never generated any revenues and may never achieve revenues or profitability.
Currently, we have no products approved for commercial sale and, to date, we have not generated any revenues. Our ability to generate
revenue depends heavily on:
· successful development of our first product candidate in our pipeline;
· the successful commercialization of our product candidates; and
· market acceptance of our products.
All of our existing product
candidates are in early stages of development. It will be several years, if ever, until we have a commercial drug product available for
resale. If we do not successfully develop and commercialize these products, we will not achieve revenues or profitability in the foreseeable
future, if at all. If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations.
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We are a development stage
company with a limited operating history, making it difficult for you to evaluate our business and your investment. We are in the development
stage and our operations and the development of our proposed products are subject to all of the risks inherent in the establishment of
a new business enterprise, including but not limited to:
· the absence of an operating history;
· the lack of commercialized products;
· insufficient capital;
· expected substantial and continual losses for the foreseeable future;
· reliance on key personnel;
Because we are subject to these risks, you
may have a difficult time evaluating our business and your investment in our company.
Our ability to become profitable
depends primarily on the following factors:
· our R&D efforts, including the timing and cost of clinical trials; and
Even if we successfully develop and market
our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability.
We have incurred significant
operating losses and may not ever be profitable. As of June 30 2021, we had a cash and cash equivalent balance of $20,516,677. Also,
we have incurred significant operating losses since its inception, resulting in an accumulated deficit of $114,385,313 at June 30,
2021. Such losses are expected to continue for the foreseeable future.
We will need to raise substantial additional
capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms.
While we believe we will
be able to raise sufficient cash in the capital markets, to be able to take at least one of our drug candidates into initial human
clinical trials, we currently do not have sufficient resources to complete the development, clinical trials, and commercialization
of any of our proposed products. Management is actively exploring additional required funding through debt or equity financing
pursuant to its plan. There is no assurance that the Company will be successful in obtaining sufficient financing on terms
acceptable to the Company to fund continuing operations. Management believes that as a result of the management plan, the
Company’s existing resources and access to the capital markets will permit the Company to fund planned operations and
expenditures. However, the Company cannot provide assurance that its plans will not change or that changed circumstances will not
result in the depletion of its capital resources more rapidly than it currently anticipates.
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In the event that we cannot
obtain acceptable financing, or that we are unable to secure additional financing on acceptable terms, we would be unable to complete
development of our various drug candidates. This would necessitate implementing staff reductions and operational adjustments that would
include reductions in the following business areas:
· research and development programs;
· a search for third party marketing partners to market our products for us.
The amount of capital we may need will depend
on many factors, including the:
· progress, timing and scope of our research and development programs;
· progress, timing and scope of our preclinical studies and clinical trials;
· time and cost necessary to obtain regulatory approvals;
· time and cost necessary to respond to technological and market developments;
Our fixed expenses, such as
real estate taxes and facility and equipment maintenance, rent, and other contractual commitments, may increase in the future, as we may:
· enter into leases for new facilities and capital equipment;
· enter into additional licenses and collaborative agreements; and
· incur additional expenses associated with being a public company.
We have limited experience in drug development,
have not yet conducted any clinical trials and may not be able to successfully develop any drugs.
Until the formation of NanoViricide, Inc.
(the Company’s predecessor prior to the reverse merger in 2005) our management and key personnel had no experience in pharmaceutical
drug development and, consequently, may not be able to successfully develop any drugs. To date, we have engaged only in pre-clinical activities
and have not yet conducted any clinical trials. Our ability to achieve revenues and profitability in our business will depend, among other
things, on our ability to:
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· complete laboratory testing and human studies;
· obtain and maintain necessary intellectual property rights to our products;
Development of pharmaceutical products is
a time-consuming process, subject to a number of factors, many of which are outside of our control. Consequently, we can provide no assurance
of the successful and timely development of new drugs.
Our drug candidates are in
their developmental stage. Further development and extensive testing will be required to determine their technical feasibility and commercial
viability. Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into
reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available for
a few years. The proposed development schedules for our drug candidates may be affected by a variety of factors, including technological
difficulties, proprietary technology of others, and changes in government regulation, many of which will not be within our control. Any
delay in the development, introduction or marketing of our drug candidates could result either in such drugs being marketed at a time
when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives.
In light of the long-term nature of our projects, the unproven technology involved and the other factors described elsewhere in “Risk
Factors”, we may not be able to complete successfully the development or marketing of any drugs.
We may fail to successfully
develop and commercialize our drug candidates if they:
· do not receive necessary approval from the FDA or foreign regulatory agencies;
Drug development failure can
occur at any stage of clinical trials and as a result of many factors and there can be no assurance that we or our collaborators will
reach our anticipated clinical targets. Even if we or our collaborators complete our clinical trials, we do not know what the long-term
effects of exposure to our drug candidates will be. Furthermore, our drug candidates may be used in combination with other treatments
and there can be no assurance that such use will not lead to unique safety issues. Failure to complete clinical trials or to prove that
our drug candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us
to reduce the scope of or discontinue our operations.
We must comply with significant and complex
government regulations, compliance with which may delay or prevent the commercialization of our drug candidates.
The R&D, manufacture
and marketing of drug candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities
in other countries. These national agencies and other federal, state, local and foreign entities regulate, among other things,
R&D activities (including testing in primates and in humans) and the testing, manufacturing, handling, labeling, storage, record
keeping, approval, advertising and promotion of the products that we are developing. Noncompliance with applicable requirements can
result in various adverse consequences, including approval delays or refusals to approve drug licenses or other applications,
suspension or termination of clinical investigations, revocation of approvals previously granted, fines, criminal prosecution,
recalls or seizures of products, injunctions against shipping drugs and total or partial suspension of production and/or refusal to
allow a company to enter into governmental supply contracts.
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The process of obtaining FDA
approval has historically been costly and time consuming. Current FDA requirements for a new human drug or biological product to be marketed
in the United States include: (1) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain
preliminary information on the product’s safety; (2) filing with the FDA of an IND application to conduct human clinical trials
for drugs or biologics; (3) the successful completion of adequate and well-controlled human clinical investigations to establish
the safety and efficacy of the product for its recommended use; and (4) filing by a company and acceptance and approval by the FDA
of a New Drug Application, or NDA, for a drug product or a biological license application, or BLA, for a biological product to allow commercial
distribution of the drug or biologic. A delay in one or more of the procedural steps outlined above could be harmful to us in terms of
getting our drug candidates through clinical testing and to market.
The FDA reviews the results
of the clinical trials and may order the temporary or permanent discontinuation of clinical trials at any time if it believes the drug
candidate exposes clinical subjects to an unacceptable health risk. Investigational drugs used in clinical studies must be produced in
compliance with current good manufacturing practice, or GMP, rules pursuant to FDA regulations.
Sales outside the United States
of products that we develop will also be subject to regulatory requirements governing human clinical trials and marketing for drugs and
biological products and devices. The requirements vary widely from country to country, but typically the registration and approval process
takes several years and requires significant resources. In most cases, even if the FDA has not approved a product for sale in the United
States, the product may be exported to any country if it complies with the laws of that country and has valid marketing authorization
by the appropriate authority. There are specific FDA regulations that govern this process.
We also are subject to the
following risks and obligations, related to the approval of our products:
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We can provide no assurance that our drug
candidates will obtain regulatory approval or that the results of clinical studies will be favorable.
The testing, marketing and
manufacturing of any product for use in the United States will require approval from the FDA. We cannot predict with any certainty the
amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical and clinical
trials may reveal that one or more products are ineffective or unsafe, in which event further development of such products could be seriously
delayed or terminated. Moreover, obtaining approval for certain products may require testing on human subjects of substances whose effects
on humans are not fully understood or documented. Delays in obtaining FDA or any other necessary regulatory approvals of any proposed
drug and failure to receive such approvals would have an adverse effect on the drug’s potential commercial success and on our business,
prospects, financial condition and results of operations. In addition, it is possible that a proposed drug may be found to be ineffective
or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this
event, we may be required to withdraw such proposed drug from the market. To the extent that our success will depend on any regulatory
approvals from government authorities outside of the United States that perform roles similar to that of the FDA, uncertainties similar
to those stated above will also exist.
Preclinical and clinical
studies of our product candidates may not be successful. If we are unable to generate successful results from preclinical and clinical
studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed.
We
have no products on the market and all of our product candidates are in preclinical development. In particular, none of our product candidates
have ever been tested in a human subject. Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for
and, if approved, successfully commercializing our product candidates, either alone or with third parties. Before obtaining regulatory
approval for the commercial distribution of our product candidates, we or an existing or future collaborator must conduct extensive preclinical
tests and clinical trials to demonstrate the safety, purity and potency of our product candidates.
The
success of our product candidates will depend on several factors, including the following:
· successful results from preclinical and clinical studies;
· receipt of marketing approvals from applicable regulatory authorities;
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If
we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to
successfully complete the development or commercialization of our product candidates, which would materially harm our business.
Because
the results of preclinical testing are
not necessarily predictive of future results, our products may not have favorable results in our planned clinical trials.
Even
if we have positive results from our preclinical testing
of our products, this may not necessarily be predictive of the results from our planned clinical trials in humans. Many companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical development,
and we cannot be certain that we will not face similar setbacks. Moreover, preclinical and
clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates
performed satisfactorily in preclinical studies and
clinical trials nonetheless failed to obtain FDA approval. If we fail to produce positive results in our clinical trials, the development
timeline and regulatory approval and commercialization prospects for our products, and, correspondingly, our business and financial prospects,
would be materially adversely affected.
Even if we obtain regulatory approvals,
our marketed drug candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and foreign regulations,
we could lose our approvals to market these drugs and our business would be seriously harmed.
Following any initial regulatory
approval of any drugs we may develop, we will also be subject to continuing regulatory review, including the review of adverse experiences
and clinical results that are reported after our drug candidates are made commercially available. This would include results from any
post-marketing tests or vigilance required as a condition of approval. The manufacturer and manufacturing facilities we use to make any
of our drug candidates will also be subject to periodic review and inspection by the FDA. The discovery of any previously unknown problems
with the drug, manufacturer or facility may result in restrictions on the drug or manufacturer or facility, including withdrawal of the
drug from the market. If we are required to withdraw all or more of our drugs from the market, we may be unable to continue revenue-generating
operations. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured drugs ourselves, including
reliance on the third-party manufacturer for regulatory compliance. Our drug promotion and advertising is also subject to regulatory requirements
and continuing FDA review.
Development of our drug candidates requires
a significant investment in R&D. Our R&D expenses in turn, are subject to variation based on a number of factors, many of which
are outside of our control. A sudden or significant increase in our R&D expenses could materially and adversely impact our results
of operations.
Our R&D cost estimates
and budgets are based on discussions with industry professionals and service providers. These may not take into account all of the activities
involved for the development. Additionally, regulatory requirements may change from time to time and may dictate additional activities
that lead to increased expenditures beyond budgeted. For example, U.S. FDA is now requiring that IND applications be submitted in eCTD
format.
Because we expect to expend
substantial resources on R&D, our success depends in large part on the results as well as the costs of our R&D. A failure in our
R&D efforts or substantial increase in our R&D expenses would adversely affect our results of operations. R&D expenditures
are uncertain and subject to much fluctuation. Factors affecting our R&D expenses include, but are not limited to:
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We will be unable to proceed with our business plan without obtaining
additional financing to support its budgeted Research and Development and other costs.
We believe we have sufficient
funds on hand to take one drug candidate into the IND application stage.
However, we believe we will
require approximately an additional $3 million to pursue the FDA approval process including an initial IND filing. There can be no assurance
that we will be able to raise sufficient funds or that such funds will be raised on terms that will be favorable to us.
We have estimated a total
cash expenditure budget of approximately $16 million for the next 12 months, of which approximately $12 million is expected to be spent
on research and development for our drug candidates, including the IND filing, human clinical trials of one of our lead drug candidates
NV-CoV-2 and NV-Covid-2-R for Treatment of Coronavirus deceases, and approximately $4 million is budgeted for general and administrative
expenses.
We are aware of numerous products
under development or manufactured by competitors that are used for the prevention or treatment of certain diseases we have targeted for
drug development. Various companies are developing biopharmaceutical products that potentially directly compete with our drug candidates
even though their approach to such treatment is different.
We hope that our drug candidates
under development and in clinical trials will address major markets within the anti-viral sector. Our competition will be determined in
part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing
of the market introduction of some of our potential drugs or of competitors' products may be an important competitive factor. Accordingly,
the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial
quantities to market are important competitive factors. We expect that competition among drugs approved for sale will be based on various
factors, including product efficacy, safety, reliability, availability, price and patent protection.
The successful
development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals,
could cause us to abandon development of our drug candidates.
Successful development of
biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Products that appear
promising in the early phases of development may fail to reach the market for several reasons including:
·
pre-clinical study results that may show the product to be less effective than desired (e.g., the study failed to meet its primary objectives)
or to have harmful or problematic side effects;
·
failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused
by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or an
IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety
or manufacturing issues;
·
manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economical; and
·
the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized.
Success in pre-clinical and early clinical studies
does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations
that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application
for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult
to predict.
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We have limited experience in conducting
or supervising clinical trials and must outsource all clinical trials.
We have limited experience
in conducting or supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval
by the Food and Drug Administration (“FDA”). The regulatory process to obtain approval for drugs for commercial sale involves
numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues
to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA. In the event that our
protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials to validate our drugs in
the face of such examination, we might not be able to meet the requirements that allow our drugs to be approved for sale.
Because we have limited experience
in conducting or supervising clinical trials, we plan to outsource our clinical trials to third parties. We have no control over their
compliance with procedures and protocols used to complete clinical trials in accordance with standards required by the agencies that approve
drugs for sale. If these subcontractors fail to meet these standards, the validation of our drugs would be adversely affected, causing
a delay in our ability to meet revenue-generating operations.
We are subject to risks inherent in conducting
clinical trials. The risk of non-compliance with FDA-approved good clinical practices by clinical investigators, clinical sites, or data
management services could delay or prevent us from developing or ever commercializing our drug candidates.
Agreements with clinical investigators
and medical institutions for clinical testing and with other third parties for data management services place substantial responsibilities
on these parties, which could result in delays in, or termination of, our clinical trials if these parties fail to perform as expected.
For example, if any of our clinical trial sites fail to comply with FDA-approved good clinical practices, we may be unable to use the
data gathered at those sites. If these clinical investigators, medical institutions or other third parties do not carry out their contractual
duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised
due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated,
and we may be unable to obtain regulatory approval for or successfully commercialize our drug candidates.
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We or regulators may suspend
or terminate our clinical trials for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we
believe that they present an unacceptable risk to the patients enrolled in our clinical trials. In addition, regulatory agencies may order
the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted
in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to the patients enrolled in our
clinical trials.
Our clinical trial operations
will be subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical trial sites are not in
compliance with applicable regulatory requirements for conducting clinical trials, we may receive reports of observations or warning letters
detailing deficiencies, and we will be required to implement corrective actions. If regulatory agencies deem our responses to be inadequate,
or are dissatisfied with the corrective actions that we or our clinical trial sites have implemented, our clinical trials may be temporarily
or permanently discontinued, we may be fined, we or our investigators may be precluded from conducting any ongoing or any future clinical
trials, the government may refuse to approve our marketing applications or allow us to manufacture or market our drug candidates or we
may be criminally prosecuted. If we are unable to complete clinical trials and have our products approved due to our failure to comply
with regulatory requirements, we will be unable to commence revenue-generating operations.
Efforts of government and third-party payers
to contain or reduce the costs of health care may adversely affect our revenues even if we were to develop an FDA approved drug.
Our ability to earn sufficient
returns on our drug candidates may depend in part on the extent to which government health administration authorities, private health
coverage insurers and other organizations will provide reimbursement for the costs of such drugs and related treatments. Significant uncertainty
exists as to the reimbursement status of newly approved health care drugs, and we do not know whether adequate third-party coverage will
be available for our drug candidates. If our current and proposed drugs are not considered cost-effective, reimbursement to the consumers
may not be available or sufficient to allow us to sell drugs on a competitive basis. The failure of the government and third-party payers
to provide adequate coverage and reimbursement rates for our drug candidates could adversely affect the market acceptance of our drug
candidates, our competitive position and our financial performance.
If we were to successfully
develop approvable drugs, before we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and
process or the manufacturing facility and process of the third party or parties with whom we may outsource our manufacturing activities.
In addition, the manufacture of our products must comply with the FDA’s current Good Manufacturing Practices regulations, commonly
known as GMP regulations. The GMP regulations govern quality control and documentation policies and procedures. Our manufacturing facilities,
if any in the future and the manufacturing facilities of our third party manufacturers will be continually subject to inspection by the
FDA and other state, local and foreign regulatory authorities, before and after product approval. We cannot guarantee that we, or any
potential third party manufacturer of our products, will be able to comply with the GMP regulations or other applicable manufacturing
regulations.
As of the date of this filing,
we have approximately seventeen employees including the employees at TheraCour, and several consultants and independent contractors. The
only consultant/contractor that we consider critical to the Company is TheraCour. Our relationship with TheraCour is discussed below.
All other consultant/contractors would be more readily replaceable. We have significantly expanded our operations and staff materially
and our new employees include a number of key managerial, technical, financial, R&D and operations personnel. The expansion of our
business will continue to place a significant strain on our limited managerial, operational and financial resources. We may need to hire
additional personnel, in key managerial, technical, financial, R&D and operations areas. We have no experience in integrating multiple
employees when hired. Therefore, there is a substantial risk that we will not be able to integrate new employees into our operations which
would have a material adverse effect on our business, prospects, financial condition and results of operations.
Confidentiality agreements
with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information. Disclosure of our
trade secrets or proprietary information could compromise any competitive advantage that we have.
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We depend upon confidentiality
agreements with our officers, employees, consultants, and subcontractors to maintain the proprietary nature of the technology. These measures
may not afford us sufficient or complete protection and may not afford an adequate remedy in the event of an unauthorized disclosure of
confidential information. In addition, others may independently develop technology similar to ours, otherwise avoiding the confidentiality
agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition, and results of
operations.
We will rely upon licensed patents to protect
our technology. We may be unable to obtain or protect such intellectual property rights, and we may be liable for infringing upon the
intellectual property rights of others.
Our ability to compete effectively
will depend on our ability to maintain the proprietary nature of our technologies and the proprietary technology of others with which
we have entered into licensing agreements. We have exclusive licenses from TheraCour to novel technologies, proprietary technologies,
and knowhow, some of which has been filed in patent applications, and we expect to file patents of our own in the coming years. There
can be no assurance that any of these patent applications will ultimately result in the issuance of a patent with respect to the technology
owned by us or licensed to us. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain
and involves complex legal and factual considerations. The standards that the United States Patent and Trademark Office use to grant patents
are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter
and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future
protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. Further,
we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures
to protect our rights in the technology. If any trade secret, know-how or other technology not protected by a patent were to be disclosed
to or independently developed by a competitor, our business and financial condition could be materially adversely affected.
We do not believe that any
of the drug candidates we are currently developing infringe upon the rights of any third parties nor are they infringed upon by third
parties; however, there can be no assurance that our technology will not be found in the future to infringe upon the rights of others
or be infringed upon by others. In such a case, others may assert infringement claims against us, and should we be found to infringe upon
their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including
treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to any damages we might
have to pay, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or redesign
our drug candidates so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible.
Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology and the technology
exclusively licensed from the TheraCour Pharma. Thus, the proprietary nature of our technology or technology licensed by us may not provide
adequate protection against competitors.
Moreover, the cost to us of
any litigation or other proceeding relating to technology we license and other intellectual property rights, even if resolved in our favor,
could be substantial, and the litigation would divert our management’s efforts. Uncertainties resulting from the initiation and
continuation of any litigation could limit our ability to continue our operations.
Other companies or organizations may assert
patent rights that prevent us from developing and commercializing our drug candidates.
We are in a relatively
new scientific field that has generated many different patent applications from organizations and individuals seeking to obtain
important patents in the field. Because the field is so new, very few of these patent applications have been fully processed by
government patent offices around the world, and there is a great deal of uncertainty about which patents will issue, when, to whom,
and with what claims. It is possible that there will be significant litigation and other proceedings, such as interference
proceedings in various patent offices, relating to patent rights in the field. Others may attempt to invalidate TheraCour’s
patents or other intellectual property rights. Even if our rights are not directly challenged, disputes among third parties could
lead to the weakening or invalidation of those intellectual property rights.
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Thus, it is possible that
one or more organizations will hold patent rights to which we will need a license. Any license required under any patent may not be made
available on commercially acceptable terms, if at all. In addition, such licenses are likely to be non-exclusive and, therefore, our competitors
may have access to the same technology licensed to us. If we fail to obtain a required license and are unable to design around a patent,
we may be unable to effectively market some of our technology and drug candidates, which could limit our ability to generate revenues
or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.
We are dependent upon TheraCour for the
rights to develop the products we intend to sell and our license agreements with TheraCour require that TheraCour is the sole developer
and supplier of our licensed products.
Our ability to develop, manufacture
and sell the products the Company plans to develop is derived from our Licensing Agreements with TheraCour. The Agreements may be terminated
by TheraCour as a result of: the insolvency or bankruptcy proceedings by or against the Company, a general assignment by the Company to
its creditors, the dissolution of the Company, cessation by the Company of business operations for ninety (90) days or more or the commencement
by the Company or an affiliate to challenge or invalidate the issued patents.
The Company does not hold
the rights to any other patents nor does the Company conduct its own research and development to develop other products to manufacture
and sell. In addition, TheraCour is the sole developer of our licensed products and we are required to pay TheraCour fess for indirect
and direct costs incurred by TheraCour for its licensed products. Therefore, we are dependent upon TheraCour for all of our product development
needs. If the Company’s Agreement with TheraCour is terminated, it is unlikely we will be able to commence revenue-generating operations
or that the Company could continue operating at all.
The expiration or loss of patent protection
may adversely affect our future revenues and operating earnings.
We rely on patent, trademark,
trade secret and other intellectual property protection in the discovery, research and of our product candidates. In particular, patent
protection is important in the development and eventual commercialization of our products and product candidates. Patents covering our
products and product candidates normally provide market exclusivity, which is important in order for our products and product candidates
to become profitable.
Certain of the patents, that
comprise the intellectual property that we license, expire between 2022 and 2028. While we believe the patent holders may seek additional
patent coverage that may protect the technology underlying these patents, there can be no assurances that such additional patent protection
will be granted, or if granted, that these patents will not be infringed upon or otherwise held enforceable. Even if we are successful
in obtaining a patent, patents have a limited lifespan and we currently do not have any products for sale. In the United States, the natural expiration of
a utility patent typically is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent,
and the protection it affords, is limited. Without patent protection for our products and product candidates, we may be open to competition
from generic versions of such methods and devices.
We lack suitable facilities for clinical
testing; reliance on third parties.
The Company does not have
facilities that could be used to conduct clinical testing. We expect to contract with third parties to conduct all clinical testing required
to obtain approvals for any drugs that we might develop. We currently outsource all testing to a number of third parties in various collaborations
and service contracts. Any of our collaborators or service providers may discontinue the service contract or collaboration. If this were
to occur, then we would be required to modify our priorities and goals, obtain other collaborators or service providers to replace the
ones we lose, or we may even be forced to abandon certain drug development programs. In addition, any failures by third parties to adequately
perform their responsibilities may delay the submission of our proposed products for regulatory approval, impair our ability to deliver
our products on a timely basis, increase our costs, or otherwise impair our competitive position.
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We have limited manufacturing experience.
The Company has never manufactured
products in the highly regulated environment of pharmaceutical manufacturing. There are numerous regulations and requirements that must
be maintained to obtain licensure and the permits required to commence manufacturing, as well as additional requirements to continue manufacturing
pharmaceutical products. We now own facilities that could be used to manufacture clinical quantities of any products that might be developed
by the Company. We believe that this cGMP-capable facility may allow us to produce limited quantities of a drug after approval for initial
market entry, and that such an effort may make commercial sense if the treatment course requirements and afflicted patient populations
are limited, and if the remuneration for the treatment course is appropriate. However, we do not own, nor lease facilities suitable for
cGMP manufacture of any of our drug candidates in large commercial quantities, nor do we have the resources at this time to acquire or
lease suitable facilities. At present, we have not retained any contract manufacturing organizations (CMO) for commercial manufacture
or for clinical product manufacture.
We may be unable to attract, retain, and
motivate skilled personnel which will delay our product development programs and our research and development efforts.
Our success depends on our
continued ability to attract, retain, and motivate highly qualified scientific personnel who must undergo extensive training to assist
in our research programs. Competition for skilled and qualified personnel and academic and other research collaborations is intense. If
we lose the services of personnel with the necessary skills, or if there are extensive delays in training such personnel, it could significantly
impede the achievement of our research and development objectives. We are currently experiencing extreme staffing constraints as well
as financing constraints that have already caused substantial delays and may continue to cause further delays in our estimated timelines,
unless we are successful at raising additional funds and at attracting and retaining highly skilled employees with specific skill-sets.
There can be no assurance that we will be able to raise sufficient funding or that even if we are able to raise funding on terms favorable
to the Company, that we will be able to hire and retain such qualified employees, The inability to hire and retain these employees will
significantly delay our objectives including filing an IND with the FDA.
We have no sales and marketing personnel.
We are an early stage development
company with limited resources. We do not currently have any products available for sale, so have not secured sales and marketing staff
at this early stage of operations. We cannot generate sales without a sales or marketing staff and we cannot guarantee we will be successful
in developing one. Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party
manufacturers fail to comply with manufacturing regulations.
Since we cannot predict whether or when
we will obtain regulatory approval to commercialize our product candidates, we cannot predict the timing of any future revenue from these
product candidates.
We
cannot commercialize any of our product candidates to generate revenue until the appropriate regulatory authorities have reviewed and
approved the marketing applications for the product candidates. We cannot ensure that the regulatory agencies will complete their review
processes in a timely manner or that we will obtain regulatory approval for any product candidate that we or our collaborators develop.
Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the product
and requires the expenditure of substantial resources. Regulatory approval processes outside the United States include all of the risks
associated with the FDA approval process. In addition, we may experience delays or rejections 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.
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We license our core technology from TheraCour
and we are dependent upon them as they have exclusive development rights. If we lose the right to utilize any of the proprietary information
that is the subject of this license agreement, we may incur substantial delays and costs in development of our drug candidates
The Company has entered into
Material License Agreements with TheraCour. TheraCour has exclusive rights to develop exclusively for us, the materials that comprise
the core drugs of our planned business. TheraCour is a development stage company with limited financial resources and needs the Company’s
progress payments to further the development of the nanoviricides. The Company controls the research and work TheraCour performs on its
behalf and no costs may be incurred without the prior authorization or approval of the Company.
We depend on TheraCour and
other third parties to perform manufacturing activities effectively and on a timely basis. If these third parties fail to perform as required,
this could impair our ability to deliver our products on a timely basis or cause delays in our clinical trials and applications for regulatory
approval, and these events could harm our competitive position and adversely affect our ability to commence revenue-generating operations.
The manufacturing process for pharmaceutical products is highly regulated, and regulators may shut down manufacturing facilities that
they believe do not comply with regulations. We, and our manufacturers are subject to the FDA’s current Good Manufacturing Practices,
which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards and similar
regulations are in effect in other countries. In addition, our manufacturing operations are subject to routine inspections by regulatory
agencies.
Our collaborative relationships with third
parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.
We anticipate substantial
reliance upon strategic collaborations for marketing and the commercialization of our drug candidates and we may rely even more on strategic
collaborations for R&D of our other drug candidates. Our business depends on our ability to sell drugs to both government agencies
and to the general pharmaceutical market. Offering our drug candidates for non-medical applications to government agencies does not require
us to develop new sales, marketing or distribution capabilities beyond those already existing in the company. Selling antiviral drugs,
however, does require such development. We plan to sell antiviral drugs through strategic partnerships with pharmaceutical companies.
If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our revenue and drug development
may be limited. To date, we have not entered into any strategic collaboration with third parties capable of providing these services.
In addition, we have not yet marketed or sold any of our drug candidates or entered into successful collaborations for these services
in order to ultimately commercialize our drug candidates.
If we determine to enter into
R&D collaborations during the early phases of drug development, our success will in part depend on the performance of our research
collaborators. We will not directly control the amount or timing of resources devoted by our research collaborators to activities related
to our drug candidates. Our research collaborators may not commit sufficient resources to our programs. If any research collaborator fails
to commit sufficient resources, our preclinical or clinical development programs related to such collaboration could be delayed or terminated.
Also, our collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being
developed in collaboration with us. Finally, if we fail to make required milestone or royalty payments to our collaborators or to observe
other obligations in our agreements with them, our collaborators may have the right to terminate those agreements.
Manufacturers producing our
drug candidates must follow current GMP regulations enforced by the FDA and foreign equivalents. If a manufacturer of our drug candidates
does not conform to the current GMP regulations and cannot be brought up to such a standard, we will be required to find alternative manufacturers
that do conform. This may be a long and difficult process and may delay our ability to receive FDA or foreign regulatory approval of our
drug candidates and cause us to fall behind on our business objectives.
Establishing strategic
collaborations is difficult and time-consuming. Our discussion with potential collaborators may not lead to the establishment of
collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our
financial, regulatory or intellectual property position. Even if we successfully establish new collaborations, these relationships
may never result in the successful development or commercialization of our drug candidates or the generation of sales revenue. To
the extent that we enter into collaborative arrangements, our drug revenues are likely to be lower than if we directly marketed and
sold any drugs that we may develop.
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Management of our relationships
with our collaborators will require:
· significant time and effort from our management team;
· effective allocation of our resources to multiple projects.
We employ the use of certain chemical and
biological agents and compounds that may be deemed hazardous and we are therefore subject to various environmental laws and regulations.
Compliance with these laws and regulations may result in significant costs, which could materially reduce our ability to become profitable.
We use hazardous materials,
including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment. As appropriate,
we safely store these materials and wastes resulting from their use at our laboratory facility pending their ultimate use or disposal.
We contract with a third party to properly dispose of these materials and wastes. We are subject to a variety of federal, state and local
laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes. We may
incur significant costs complying with environmental laws and regulations adopted in the future.
We cannot eliminate the risk
of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials,
we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs
associated with civil or criminal fines and penalties for failure to comply with such laws and regulations. We may incur substantial costs
in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations
may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial
fines, penalties or other sanctions.
If we use biological and hazardous materials
in a manner that causes injury, we may be liable for damages.
Our R&D and manufacturing
activities will involve the use of biological and hazardous materials. Although we believe our safety procedures for handling and disposing
of these materials comply with federal, state and local laws and regulations, we cannot entirely eliminate the risk of accidental injury
or contamination from the use, storage, handling or disposal of these materials. We carry $7,000,000 casualty and general liability
insurance policies. Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines
in an amount exceeding our resources and insurance coverage, and our clinical trials or regulatory approvals could be suspended.
We depend upon our senior management and
their loss or unavailability could put us at a competitive disadvantage.
We currently depend upon the
efforts and abilities of our management team. The loss or unavailability of the services of any of these individuals for any significant
period of time could have a material adverse effect on our business, prospects, financial condition and results of operations. We have
not obtained, do not own, nor are we the beneficiary of key-person life insurance for all of our key personnel.
The Company believes that
Dr. Anil Diwan, is critical to the success of the Company. The Company is a limited beneficiary of a certain amount of key man insurance
for Anil Diwan that the Company maintains. However, there can be no assurances that the amount of the key man insurance coverage would
be sufficient to provide replacement of this key officer for continuing the Company’s operations in a timely manner, should such
an event arise.
The Company also maintains
a limited amount of Directors and Officers Liability insurance coverage to protect all of its directors and executive officers taken together.
There can be no assurance that this D&O coverage will be sufficient to cover the costs of the events that may lead to its invocation,
in which case, there could be a substantial impact on the Company’s ability to continue operations, should such an unforeseen event
occur.
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There are conflicts of interest among our
officers, directors and stockholders.
Certain of our executive officers
and directors and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf
of other persons. Neither we, nor our stockholders will have any rights in these ventures or their income or profits. Specifically, Dr.
Anil Diwan owns approximately 90% of the capital stock of TheraCour, which as of June 30, 2021, owned 4.1% of our common stock,