NanoViricides, Inc.
(the “Registrant”) is furnishing this Current Report on Form 8-K to indicate it intends to rely on the Order of the
Securities and Exchange Commission of March 25, 2020 (Release No. 34-88465) (the “Order”), which allows for the delay
of certain filings required under the Securities and Exchange Act of 1934, as amended. The Order provides that a registrant subject
to the reporting requirements of Exchange Act Section 13(a) or 15(d), and any person required to make any filings with respect
to such a registrant, is exempt from any requirement to file or furnish materials with the Commission under Exchange Act Sections
13(a), 13(f), 13(g), 14(a), 14(c), 14(f), 15(d) and Regulations 13A, Regulation 13D-G (except for those provisions mandating the
filing of Schedule 13D or amendments to Schedule 13D), 14A, 14C and 15D, and Exchange Act Rules 13f-1, and 14f-1, as applicable.
The Registrant is relying
on the Order in connection with the Registrant’s Quarterly Report on Form 10-Q for the period ended March 31, 2020, as a
result of the circumstances set forth below. The Registrant’s operations and business have experienced disruption due to
the unprecedented conditions surrounding the COVID-19 pandemic.
The Registrant has
been working diligently on development of therapeutics for the treatment of COVID-19, in addition to its current primary business
activity of development of therapeutics against Shingles. While the Registrant’s employees and immediate families did not
have any known incidences of COVID-19 infection, several of the registrant’s 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, the primary work of the Registrant 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 the Registrant including the preparation of the Registrant’s financial statements and management report.
Additionally, the Registrant’s accounting staff has been unavailable from time to time due to self-isolation and other local
travel and shelter-in-place restrictions.
Accordingly, in reliance
upon the Order, the Registrant expects to file its Quarterly Report on Form 10-Q no later than 45 days after the due date of filing
of May 15, 2020.
Pursuant to the Order,
following are the Risk Factors disclosing the impact of COVID-19 onto the Registrant’s business and operations:
Risks 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.
As of the date hereof,
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 the Registrant’s 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 the Registrant in the development of its financial statements.
As a result of the travel and work restrictions stemming from the COVID-19 pandemic, the Registrant may be unable to fully review
and certify certain financial statements that it needs to permit the Registrant to file timely and accurate quarterly Reports on
Form 10-Q, including for the quarter ended March 31, 2020, by the prescribed dates without undue hardship and expense to the Registrant.
Due to these factors, the registrant is
unable to file the Form 10-Q for quarterly period ending March 31, 2020 on May 15, 2020.
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 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 COVID-19 pandemic
related issues in terms of the design and conduct of a clinical trial for shingles.
Risks Related to Securities Markets and
Investments in Our Securities
General securities market uncertainties resulting from
the COVID-19 pandemic.
Since the outset of
the pandemic the US and worldwide national securities markets have undergone unprecedented stress due to the uncertainties of the
pandemic and the resulting reactions and outcomes of government, business and the general population. These uncertainties have
resulted in declines in all market sectors, increases in volumes due to flight to safety and governmental actions to support the
markets. As a result, until the pandemic has stabilized, the markets may not be available to the Registrant for purposes of raising
required capital. Should we not be able to obtain financing when required, in the amounts necessary to execute on our plans in
full, or on terms which are economically feasible we may be unable to sustain the necessary capital to pursue our strategic plan
and may have to reduce the planned future growth and scope of our operations.
Cautionary Note Regarding Forward-Looking
Statements
This Current Report on Form 8-K contains
forward-looking statements that reflect the Registrant's current expectation regarding future events. Actual events could differ
materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release,
and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue
reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors, which are,
in some cases, beyond the Registrant's control and which could, and likely will, materially affect actual results, levels of activity,
performance or achievements. The Registrant assumes no obligation to publicly update or revise these forward-looking statements
for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking
statements, even if new information becomes available in the future. Important factors that could cause actual results to differ
materially from the Registrant's expectations include, but are not limited to, those factors that are disclosed under the heading
"Risk Factors" and elsewhere in documents filed by the Registrant from time to time with the United States Securities
and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors,
they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective;
successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to
the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.