Basis of Presentation:
The information presented as of
June 30, 2020
and for the
three
-month and
six
-month periods ended
June 30, 2020
and
2019
is unaudited, but includes all adjustments (which consist only of normal recurring adjustments) that the management of Navidea Biopharmaceuticals, Inc. (“Navidea”, the “Company,” or “we”) believes to be necessary for the fair presentation of results for the periods presented. In addition, certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The balances as of
June 30, 2020
and the results for the interim periods are
not
necessarily indicative of results to be expected for the year. The consolidated financial statements should be read in conjunction with Navidea's audited consolidated financial statements for the year ended
December
31,
2019,
which were included as part of our Annual Report on Form
10
-K.
Our consolidated financial statements include the accounts of Navidea and our wholly owned subsidiary, Navidea Biopharmaceuticals Limited, as well as those of our majority-owned subsidiary, Macrophage Therapeutics, Inc. (“MT”). All significant inter-company accounts were eliminated in consolidation.
In
March 2020,
the World Health Organization categorized the current COVID-
19
outbreak as a pandemic, and the President of the United States declared the COVID-
19
outbreak a national emergency. COVID-
19
continues to spread globally, including throughout the United States, which has impacted the global economy and
may
impact our operations, including the potential interruption of our clinical trial activities and our supply chain. To date, we do
not
believe there has been any appreciable impact to the Company's clinical development and regulatory timelines resulting from COVID-
19.
However, the COVID-
19
pandemic has adversely affected economies and financial markets worldwide, resulting in an economic downturn that could impact our business, financial condition and results of operations, including our ability to obtain additional funding, if needed. Much of the funding from the
February 2020
transactions described in Note
2
below was delayed, due in part to the COVID-
19
pandemic and its devastating impact on global financial markets. However, funding for all of these transactions has been received as of the date of filing of this Quarterly Report on Form
10
-Q. The extent to which COVID-
19
impacts our operations and financial results will depend on numerous evolving factors that we are
not
able to accurately predict, including: the duration and scope of the pandemic, government actions taken in response to the pandemic, and the impact on our ability to continue to conduct our clinical trials.