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Navidea Biopharmaceuticals Announces First Quarter 2013 Results



  Navidea Biopharmaceuticals Announces First Quarter 2013 Results

 – Business Update / Quarterly Conference Call Set for Today, May 8, 2013 at
                                8:30 am EDT –

Business Wire

DUBLIN, Ohio -- May 08, 2013

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company
focused on precision diagnostic radiopharmaceuticals, today announced business
highlights and consolidated results for the first quarter ended March 31,
2013.

“We are energized by the Lymphoseek® approval and launch in the U.S. while we
continue to advance our global registration process for the product in other
markets,” said Dr. Mark Pykett, Navidea CEO. “As we do this, we are
increasingly turning our attention to the clinical programs for our important
later-stage pipeline candidates as well. Through the rest of 2013, we expect
to advance our innovative precision diagnostics portfolio and drive a number
of potential value-enhancing events, including our Phase 3 studies set to
begin for our Alzheimer’s and Parkinson’s programs and the possible filing of
a supplemental New Drug Application for Lymphoseek in the U.S. for use in
sentinel lymph node biopsy by year end.”

First Quarter 2013 Financial Results

For the quarter ended March 31, 2013, Navidea reported a net loss attributable
to common stockholders of $7.3 million, or $0.06 per share, compared with a
net loss attributable to common stockholders of $7.0 million, or $0.07 per
share, for the same period in 2012.

Research and development expenses were $3.6 million for the quarter ended
March 31, 2013, compared to $3.9 million for the same period in 2012. The
decrease of $304,000 was primarily a result of net decreases in Lymphoseek,
NAV5001, RIGScan, and potential pipeline product development costs, offset by
net increases in NAV4694 development costs and increased headcount and related
costs to support these development efforts.

Selling, general and administrative expenses were $3.4 million for the quarter
ended March 31, 2013, compared to $2.6 million for the same period in 2012.
The net increase of $790,000 was primarily due to increased headcount and
related costs, medical affairs costs to support Lymphoseek adoption and
increased investor relations costs, offset by decreased out-of-pocket
marketing costs incurred in preparation for the commercial launch of
Lymphoseek.

As of March 31, 2013, Navidea had cash and cash equivalents totaling
approximately $9.8 million.

“We remain focused on increasing shareholder value through two primary
objectives: the successful execution of Lymphoseek launch and
commercialization, and progress on our pipeline programs to create a
foundation for sustained long-term growth. We believe we are in a solid
financial position in advance of expected revenue from Lymphoseek with a
strong balance sheet to accomplish these objectives,” said Brent Larson,
Navidea’s Chief Financial Officer. “We maintain flexible access to multiple
available funding sources, and we believe our cash flow and available
financial resources are sufficient to support the ongoing advances in our
pipeline programs and operating needs for the foreseeable future.”

Recent Business Updates

Key milestones achieved by Navidea to date in 2013 include:

Pipeline

  * Lymphoseek^®

       * Launched Lymphoseek (technetium Tc 99m tilmanocept) Injection on May
         1^st with Cardinal Health, Inc. following the March 13^th approval by
         the U.S. Food and Drug Administration. Lymphoseek is indicated for
         use in lymphatic mapping for breast cancer and melanoma and will be
         sold and distributed by Cardinal Health to health care professionals
         in the United States through its network of nuclear pharmacies.
       * Reported top-line data from the planned interim analysis of the
         NEO3-06 Phase 3 head and neck cancer clinical study of Lymphoseek
         demonstrating that Lymphoseek met its primary endpoint in
         identification of sentinel lymph nodes as compared to the gold
         standard of pathology assessment of multi-level node resection.
       * Published results of Lymphoseek Phase 3 clinical trials in breast
         cancer in Annals of Surgical Oncology showing that  Lymphoseek met
         its primary efficacy endpoint in assessment of lymphatic mapping
         performance in patients with breast cancer.
       * Announced commencement of an investigator-initiated study by
         Maimonides Medical Center to evaluate the utility of Lymphoseek in
         lymphatic mapping procedures for colorectal cancer.

  * NAV4694

       * Published results from a NAV4694 clinical trial in the Journal of
         Nuclear Medicine demonstrating positive  head-to-head comparison of
         NAV4694 and Pittsburgh Compound B, PiB, the academic gold standard
         imaging biomarker for Alzheimer’s disease (AD) and dementia β-amyloid
         imaging. The study was conducted by collaborators at Austin Health in
         Melbourne, Australia.
       * Commenced enrollment in a Phase 2b, open-label, safety and efficacy
         PET imaging study of NAV4694 for detection of cerebral β-amyloid in
         subjects diagnosed with mild cognitive impairment.
       * Completed a study of NAV4694 as a biomarker for visual detection and
         quantification of cerebral β-amyloid in diagnosing AD, a study
         designed and conducted by Navidea’s partner, AstraZeneca.

  * NAV5001

       * Enrolled the first subject in a clinical study to investigate the
         performance of NAV5001 in a SPECT imaging procedure of the brain in
         connection with Navidea’s program to evaluate NAV5001 in dementia
         with Lewy bodies.

Corporate/Financial

  * Completed two underwritten public offerings totaling 3.6 million shares of
    common stock in February and April 2013, resulting in net proceeds to the
    Company of approximately $9.3 million.
  * Drew $4 million under the $50 million credit facility with
    Platinum-Montaur Life Sciences, LLC (Montaur). Montaur also exercised
    certain warrants in March 2013, providing $1.4 million in proceeds.
  * Dr. Thomas Tulip was appointed President in addition to his continuing
    duties as Chief Business Officer effective May 1^st. Dr. Mark Pykett
    retained the title of Chief Executive Officer.

Conference Call Details

Navidea's Chief Executive Officer, Dr. Mark Pykett, Chief Business Officer,
Dr. Thomas Tulip, and Chief Financial Officer, Brent Larson, will provide a
development and business update and will discuss the Company's financial
results for the first quarter of 2013 during the conference call. The
conference call can be accessed as follows:

 
CONFERENCE CALL INFORMATION
TO PARTICIPATE LIVE:                          TO LISTEN TO A REPLAY:
Date:                      May 8, 2013        Available until:       May 22,
                                                                     2013
Time:                      8:30 a.m.          Toll-free (U.S.)       (877)
                           EDT                Dial in #:             660-6853
                                              International Dial     (201)
                                              in #:                  612-7415
Toll-free (U.S.) Dial      (877)               
in #:                      407-8031
International Dial in      (201)              Replay passcode:        
#:                         689-8031
                                              Account #:             268
                                              Conference ID #:       414024
                                                                      

About Navidea Biopharmaceuticals, Inc.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical
company focused on the development and commercialization of precision
diagnostics and radiopharmaceutical agents. Navidea is actively developing
four radiopharmaceutical agent platforms – Lymphoseek^®, NAV4694, NAV5001 and
RIGScan^TM – to help identify the sites and pathways of undetected disease and
enable better diagnostic accuracy, clinical decision-making and, ultimately,
patient care. Navidea’s strategy is to deliver superior growth and shareholder
return by bringing to market novel radiopharmaceutical agents and advancing
the Company’s pipeline through selective acquisitions, global partnering and
commercialization efforts. For more information, please visit www.navidea.com.

The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe
harbor for forward-looking statements made by or on behalf of the Company.
Statements in this news release, which relate to other than strictly
historical facts, such as statements about the Company’s plans and strategies,
expectations for future financial performance, new and existing products and
technologies, anticipated clinical and regulatory pathways, and markets for
the Company’s products are forward-looking statements within the meaning of
the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,”
and similar expressions identify forward-looking statements that speak only as
of the date hereof. Investors are cautioned that such statements involve risks
and uncertainties that could cause actual results to differ materially from
historical or anticipated results due to many factors including, but not
limited to, the Company’s continuing operating losses, uncertainty of market
acceptance of its products, reliance on third party manufacturers, accumulated
deficit, future capital needs, uncertainty of capital funding, dependence on
limited product line and distribution channels, competition, limited marketing
and manufacturing experience, risks of development of new products, regulatory
risks and other risks detailed in the Company’s most recent Annual Report on
Form 10-K and other Securities and Exchange Commission filings. The Company
undertakes no obligation to publicly update or revise any forward-looking
statements.

                                                               
NAVIDEA BIOPHARMACEUTICALS, INC.
                                                                 
CONDENSED CONSOLIDATED BALANCE SHEETS
                                                                 
                                               March 31,        December 31,
                                               2013             2012
                                               (unaudited)       
Assets:
                                                                 
Cash                                           $ 9,845,773      $ 9,118,564
Other current assets                             2,187,749        1,498,819
Non-current assets                               1,571,542        1,355,014   
                                                                 
Total assets                                   $ 13,605,064     $ 11,972,397  
                                                                 
                                                                 
Liabilities and stockholders' deficit:
                                                                 
Notes payable, net of discount, current        $ 2,769,080      $ 2,756,718
Other current liabilities                        3,058,342        3,433,821
Notes payable, net of discount                   10,240,613       6,930,112
Other liabilities                                256,422          257,122
Stockholders' deficit                            (2,719,393 )     (1,405,376 )
                                                                 
Total liabilities and stockholders'            $ 13,605,064     $ 11,972,397  
deficit
                                                                 

                                                               
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 
                                              Three Months Ended
                                              March 31,         March 31,
                                              2013              2012
                                              (unaudited)       (unaudited)
                                                                 
Revenue                                       $ -               $ 11,931
                                                                 
Operating expenses:
Research and development                        3,639,757         3,943,714
Selling, general and administrative             3,364,490         2,574,630   
Total operating expenses                        7,004,247         6,518,344   
                                                                 
Loss from operations                            (7,004,247  )     (6,506,413 )
                                                                 
Interest expense                                (363,082    )     (293,671   )
Change in derivative liabilities                -                 (184,084   )
Other income, net                               26,310            (4,904     )
                                                                 
Net loss                                        (7,341,019  )     (6,989,072 )
                                                                 
Preferred stock dividends                       -                 (25,000    )
                                                                 
Loss attributable to common                   $ (7,341,019  )   $ (7,014,072 )
stockholders
                                                                 
Loss per common share (basic and              $ (0.06       )   $ (0.07      )
diluted)
                                                                 
Weighted average shares outstanding             113,763,600       94,074,918
(basic and diluted)
                                                                 

Contact:

Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
CFO
or
Investor Relations
Stern Investor Relations, Inc.
Beth DelGiacco, 212-362-1200
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