Exhibit 99.1

 

Navidea Biopharmaceuticals Reports Third Quarter and Year-to-Date 2020 Financial Results

 

Conference Call to be held Thursday, November 12, 2020 at 5:00 pm EDT

 

DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the third quarter and year-to-date for the period ended September 30, 2020.

 

“Navidea continues to build on its clinical momentum and this quarter fully shows our ability to execute during a very trying time globally,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “The due diligence continues with Jubilant and the Phase 2b is nearing its conclusion. We are very excited to move forward and present to the FDA in the near future.”

 

Third Quarter 2020 Highlights and Subsequent Events

 

 

Executed a binding memorandum of understanding (“MOU”) on August 9, 2020 with Jubilant Draximage Inc. dba Jubilant Radiopharma, Radiopharmaceuticals Division (“Jubilant”). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s Rheumatoid Arthritis Diagnostic in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.

 

Entered into a Stock Purchase Agreement with investors, pursuant to which the investors agreed to purchase up to $25.0 million in shares of the Company’s Common Stock.

 

Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company agreed to issue to the investor 150,000 shares of newly-designated Series D Redeemable Convertible Preferred Stock (the “Series D Preferred Stock”) for an aggregate purchase price of $15.0 million. Pursuant to the Series D Preferred Stock Purchase Agreement, Keystone will purchase Series D Preferred Stock in amounts to be determined by Keystone in one or more closings during the nine-month period following the date on which the prospectus supplement to register the underlying Common Stock was filed with the SEC, provided that all of the Series D Preferred Stock must be purchased by such date. The Series D Preferred Stock will be convertible into a maximum of 5,147,000 shares of Common Stock.

 

Announced acceptance by the American College of Rheumatology (“ACR”) of the results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting (“ACR Convergence 2020”) under the title, “Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFá Therapy.”

 

Continued longitudinal imaging and clinical assessments of Arm 3 subjects, who are beginning new anti-TNFá therapy, in the NAV3-31 trial.

 

Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.

 

Converted a provisional patent on blocking off-target organ uptake of Tilmanocept to improve on-target localization.

 

 

The following information was filed by Navidea Biopharmaceuticals, Inc. (NAVB) on Thursday, November 12, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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