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Navidea Biopharmaceuticals Announces Issuance of U.S. Patent for Diagnosis and Treatment of Viral Infections

DUBLIN, Ohio–()–Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the U.S. Patent and Trademark Office (“USPTO”) issued to Navidea U.S. patent 11,007,272, entitled “Compounds and Methods for Diagnosis and Treatment of Viral Infections,” with protection to October 7, 2037.

This patent protects the use of Navidea’s mannosylated dextran-based drug delivery vehicles to deliver small molecule therapeutic payloads as possible therapies for a variety of diseases caused by a group of viruses known as flaviviruses. Specific flaviviruses disclosed in the patent include those that cause dengue, yellow fever, and Zika fever. Dengue is a common serious illness in many tropical countries, with an estimated 100-400 million infections per year according to the World Health Organization.

In humans, these flaviviruses replicate extensively, and sometimes nearly exclusively, in CD206+ macrophages. CD206+ macrophages are the primary intended targets of Navidea’s mannosylated dextran-based drug delivery vehicles, making them capable of delivering potent drugs to the cells where the virus is multiplying.

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “Our targeted therapeutics have the potential to address the large unmet medical need caused by flaviviruses given deficiencies in current therapies and/or vaccines.” Dr. Rosol continued, “The technology covered in this patent could also have implications for possible treatments of other infectious diseases where our platform might have an impact, including HIV and hepatitis C.”

Jed Latkin, Chief Executive Officer for Navidea, said, “I am proud of the work that our chemists have been doing and we continue to move the ball forward and perfect the intellectual property to protect our portfolio for the future.“

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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