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.






Research and development (“R&D”) expenses for the fourth quarter of 2018 were $854,000, compared to $1.7 million in the same period of 2017. R&D expenses for the full year of 2018 were $4.2 million, compared to $4.5 million in 2017. The decrease in both periods was primarily due to net decreases in Manocept development costs for clinical trials, coupled with decreased compensation costs resulting from headcount reduction.


Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2018 were $1.4 million, compared to $2.2 million in the same period of 2017. SG&A expenses for the full year of 2018 were $7.7 million, compared to $11.2 million during 2017. The net decrease in both periods was primarily due to decreased legal and professional services, as well as decreased general office, insurance, depreciation, rent, and travel expenses, offset by termination costs associated with the resignation of our former CEO in 2018.


Navidea’s net loss attributable to common stockholders for the fourth quarter of 2018 was $3.2 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $4.1 million, or $0.03 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the full year of 2018 was $16.1 million, or $0.09 per share (basic), compared to net income attributable to common stockholders of $74.9 million, or $0.47 per share, in 2017.


Navidea ended the fourth quarter of 2018 with $4.3 million in cash and investments.



Conference Call Details


Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.






Fourth Quarter 2018 Earnings and Business Update Conference Call



Thursday, March 7, 2019



5:00 pm (Eastern Time)


U.S. & Canada Dial-in:



Conference ID:



Webcast Link:




The recorded conference call can be replayed and will be available for 90 days following the call, available on the investor relations page of Navidea’s corporate website at www.navidea.com.





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. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. 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 release and any oral statements made with respect to the information contained in this 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. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: any future actions by Platinum-Montaur; general economic and business conditions, both nationally and in our markets; our history of 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; our expectations and estimates concerning future financial performance, financing plans and the impact of competition; our ability to raise capital sufficient to fund our development and commercialization programs; our ability to implement our growth strategy; anticipated trends in our business; advances in technologies; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; 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 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.




Navidea Biopharmaceuticals, Inc.

Jed Latkin, CEO, 614-973-7490











December 31,


December 31,










Cash and available-for-sale securities

  $ 4,275,151     $ 4,592,610  

Accounts and other receivables

    21,151       8,137,872  

Other current assets

    678,215       1,101,923  

Guaranteed earnout receivable

    -       4,809,376  

Other non-current assets

    2,034,511       2,139,655  

Total assets

  $ 7,009,028     $ 20,781,436  

Liabilities and stockholders' equity:


Notes payable, current

  $ 316,074     $ 2,353,639  

Accrued loss for CRG litigation

    -       2,887,566  

Other current liabilities

    3,062,445       2,827,198  

Deferred revenue

    700,000       11,024  

Other liabilities

    532,549       653,679  

Total liabilities

    4,611,068       8,733,106  

Navidea stockholders' equity

    1,729,639       11,379,630  

Noncontrolling interest

    668,321       668,700  

Total stockholders' equity

    2,397,960       12,048,330  

Total liabilities and stockholders' equity

  $ 7,009,028     $ 20,781,436  








Three Months Ended


Twelve Months Ended


December 31,


December 31,


December 31,


December 31,


















Royalty revenue

  $ 5,505     $ 9,126     $ 15,347     $ 9,126  

License revenue

    29,535       -       307,174       100,000  

Grant and other revenue

    84,281       386,013       846,830       1,701,311  

Total revenue

    119,321       395,139       1,169,351       1,810,437  

Cost of revenue

    22,825       3,651       96,636       3,651  

Gross profit

    96,496       391,488       1,072,715       1,806,786  

Operating expenses:


Research and development

    854,437       1,748,147       4,221,881       4,513,842  

Selling, general and administrative

    1,443,661       2,163,226       7,698,135       11,169,951  

Total operating expenses

    2,298,098       3,911,373       11,920,016       15,683,793  

Loss from operations

    (2,201,602 )     (3,519,885 )     (10,847,301 )     (13,877,007 )

Other income (expense):


Interest (expense) income, net

    (10,565 )     24,160       (30,799 )     168,971  

Change in fair value of financial instruments

    -       -       -       153,357  

Loss on extinguishment of debt

    (1,026,182 )     (2,887,566 )     (5,291,616 )     (4,201,668 )

Other, net

    (509 )     11,917       1,145       (33,339 )

Loss before income taxes

    (3,238,858 )     (6,371,374 )     (16,168,571 )     (17,789,686 )

(Provision for) benefit from income taxes

    62,583       201,333       (2,747 )     4,062,489  

Loss from continuing operations

    (3,176,275 )     (6,170,041 )     (16,171,318 )     (13,727,197 )

Discontinued operations, net of tax effect:


Income (loss) from discontinued operations

    3,387       (157,920 )     1,449       (490,758 )

Gain on sale

    -       2,269,811       43,053       89,163,811  

Net (loss) income

    (3,172,888 )     (4,058,150 )     (16,126,816 )     74,945,856  

Less loss attributable to noncontrolling interest

    (46 )     (18 )     (379 )     (210 )

Net (loss) income attributable to common stockholders

  $ (3,172,842 )   $ (4,058,132 )   $ (16,126,437 )   $ 74,946,066  

(Loss) income per common share (basic):


Continuing operations

  $ (0.02 )   $ (0.04 )   $ (0.09 )   $ (0.08 )

Discontinued operations

  $ 0.00     $ 0.01     $ 0.00     $ 0.55  

Attributable to common stockholders

  $ (0.02 )   $ (0.03 )   $ (0.09 )   $ 0.47  

Weighted average shares outstanding (basic)

    190,035,265       162,053,385       170,535,343       161,592,569  

(Loss) income per common share (diluted):


Continuing operations

  $ (0.02 )   $ (0.04 )   $ (0.09 )   $ (0.08 )

Discontinued operations

  $ 0.00     $ 0.01     $ 0.00     $ 0.53  

Attributable to common stockholders

  $ (0.02 )   $ (0.03 )   $ (0.09 )   $ 0.45  

Weighted average shares outstanding (diluted)

    190,035,265       166,465,741       170,535,343       166,016,458