Exhibit 99.1

 

Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results

 

Conference Call to be held Thursday, March 7, 2019 at 5:00 pm ET

 

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 fourth quarter and full year of 2018. Navidea reported total revenues for the quarter of $119,000. Net loss attributable to common stockholders was $3.2 million.

 

“Navidea had a productive quarter as we advanced the business and our novel imaging pipeline,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “While we had many successes this past quarter, we will continue to work hard to advance the science and seek the go ahead from the FDA to commence our pivotal RA diagnostic trials. Our newly reconstituted board and the addition of our new Chief Medical Officer have reinvigorated our efforts to make this company a success.”

 

Fourth Quarter 2018 Highlights and Subsequent Events

 

 

Filed a comprehensive three-part clinical trial proposal for imaging of rheumatoid arthritis with the U.S. Food and Drug Administration (“FDA”), following end-of-Phase 2 discussions

 

Presented corporate overviews at the 2018 BIO Investor Forum and the 2018 LD Micro Annual Event

 

Presented data on the Manocept platform at the 2018 ACR Annual Meeting and at the 2018 Radiological Society of North American Scientific Assembly and Annual Meeting

 

Received notification of acceptance by the NYSE American of the Company’s plan to regain compliance with continued listing standards; also received an extension of the deadline to remedy the low stock price to March 31, 2019

 

Won dismissal of Platinum litigation

 

Announced release of a letter by the FDA to the U.S. Patent and Trademark Office (“USPTO”) indicating that the USPTO is allowed to extend the patent for Lymphoseek® through May 2025

 

Appointed Adam D. Cutler and S. Kathryn Rouan, Ph.D. to the Navidea Board of Directors

 

Hired Michael S. Rosol, Ph.D. as Navidea’s Chief Medical Officer

 

Financial Results

 

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

 

 

Total revenues for the fourth quarter of 2018 were $119,000, compared to $395,000 in the same period of 2017. The decrease was primarily due to a reduction in grant revenue related to SBIR grants from the NIH supporting Manocept development. Total revenues for the full year of 2018 were $1.2 million, compared to $1.8 million in 2017. The decrease was primarily due to a reduction in grant revenue, offset by increased license revenue related to the sublicense of NAV4694 to Meilleur. Revenue in both years included other revenue from our marketing partners in Europe and China related to development work performed at their request.

 

 

The following information was filed by Navidea Biopharmaceuticals, Inc. (NAVB) on Thursday, March 7, 2019 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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