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.
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. As a result of the travel and work restrictions stemming from
the COVID-19 pandemic, we were unable to fully review and certify the financial statements that were needed for us to file our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 by May 15, 2020, the prescribed deadline, because our operations
and business experienced disruption due to the unprecedented conditions surrounding the COVID-19 pandemic as more fully described
below. Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 was filed on June 22, 2020 and the Company filed
Form NT 10-K on September 28, 2020 to obtain a 15 day extension to file its Form 10-K.
We have been working diligently on development of therapeutics for the treatment of COVID-19, in addition to our current primary business
activity of development of therapeutics against Shingles. Although our employees and their immediate families did not have any known incidences
of COVID-19 infection, several of our key employees have been on self-isolation from time to time, due to potential unintended exposure
to likely COVID-19 cases. While such personnel continue to work remotely on matters such as documentation and paper research, our primary
work of is focused in the laboratory and such personnel are then unavailable to conduct such work. These absences have created a number
of shortages of essential personnel needed to perform various operations for our company including the preparation of our financial statements
and management report. Additionally, our accounting staff has been unavailable from time to time due to self-isolation and other local
travel and shelter-in-place restrictions.
The filing of an Investigational Drug Application for
our first drug candidate, namely NV-HHV-101, may be delayed.
The IND application contains several sections that require information from different parties. In particular, completion of the information
regarding the drug substance and drug product, as well as characterization and detection of manufacturing intermediates may be delayed
due to specific personnel having been unavailable, or becoming unavailable in the near future, due to COVID-19 social distancing and self-isolation
guidelines or illness. In addition, the development of clinical protocol section is experiencing delays due to the impact of COVID-19
pandemic on the design and conduct of clinical trials. While we are fortunate that we do not have any on-going clinical trials, we will
need to take into account the effect of COV1D-19 pandemic related issues in terms of the design and conduct of a clinical trial for shingles.
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.
Page 52 of 106
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 2020, we had a cash and cash equivalent balance of $13,708,594.
Also, we have incurred significant operating losses since its inception, resulting in an accumulated deficit of $105,563,124 at
June 30, 2020. 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.
Page 53 of 106
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:
· complete laboratory testing and human studies;
Page 54 of 106
· 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.
Page 55 of 106
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:
Page 56 of 106
We can provide no assurance that
our drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable.
The Company reports
summary of its studies as the data become available to the Company, after analyzing and verifying same, in its press releases.
All of our products
in development are still in the pre-clinical stage, and not submitted to any regulatory agencies in any formal drug licensing or
approval processes. We have previously held a pre-IND meeting with the US FDA regarding our anti-influenza drug candidates, in
March 2012. However, since then, we have re-evaluated our priorities. We have now prioritized our HerpeCideTM program
drug candidates as our highest priority candidates.
Such strategic changes
are necessitated due to the limited resources available to us for drug development. We perform such strategic changes in order
to maximize our chances of entering into human clinical trials in the regulatory process in the earliest time frame possible, and
within the funding available to the Company, guided by input from a number of sources. Such changes are designed to accelerate
some programs and would lead to delays in some other programs that receive lower priority, due to our limited resources. We may
not be able to accurately assess the effect of such changes on our business plan.
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;
Page 57 of 106
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:
Page 58 of 106
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 $11.6 million for the next 12 months, of which approximately $9.6 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, namely Skin Cream for Topical Treatment of Shingles, and approximately, $3 million is expected to be spent
on research and development for our COVID-19 drug candidate, and $2 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.
Page 59 of 106
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.
Page 60 of 106
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.
Page 61 of 106
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.
Page 62 of 106
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 2020 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.
Page 63 of 106
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.
Page 64 of 106
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.
Page 65 of 106
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