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Navidea Announces Fourth Quarter And Full-Year 2012 Results

Navidea’s loss from operations for the fourth quarter of 2012 was $7.0 million compared to $9.0 million for the fourth quarter of 2011. Navidea’s loss from operations for the year ended December 31, 2012 was $28.0 million compared to $24.1 million for the same period of 2011. For the fourth quarter of 2012, Navidea reported a loss attributable to common stockholders of $7.2 million, or $0.07 per share, compared to a loss attributable to common stockholders of $7.6 million, or $0.08 per share, for the fourth quarter of 2011. For the year ended December 31, 2012, Navidea reported a loss attributable to common stockholders of $29.2 million, or $0.29 per share, compared to income attributable to common stockholders of $5.5 million, or $0.06 per share, for the same period in 2011. Income attributable to common stockholders in 2011 was the result of the sale of Navidea’s line of medical devices, the neoprobe ® GDS gamma detection systems, to Devicor Medical Products, Inc. in August 2011 for approximately $30 million.

Business Update

Key milestones achieved by Navidea in 2012 and to date in 2013 include:

Corporate/Financial
  • Neoprobe Corporation became Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB ) reflecting the Company’s biopharmaceutical focus on precision diagnostics development and commercialization.
  • Implemented a $50 million credit facility with Platinum-Montaur Life Sciences LLC (Montaur), of which $15 million was made immediately available, to provide flexible financial resources to fund short- and long-term development and growth plans. To date the Company has drawn a total of $4 million under the credit facility. Montaur also exercised certain warrants in December 2012 and March 2013, providing $1.9 million and $1.4 million in proceeds, respectively.
  • Completed an underwritten public offering of 1.5 million shares of common stock in February 2013, resulting in net proceeds to the Company of approximately $4.4 million after deducting expenses associated with the offering.
  • Appointed pharma industry veteran Cornelia Reininger, MD, PhD, as Chief Medical Officer to lead ongoing development of our pipeline agents, playing a key role in medical strategy, protocol design, product positioning and regulatory direction . Formerly, Dr. Reininger spearheaded development and registration of the neuroimaging agents, florbetaben for Alzheimer’s disease and DaTScan TM for Parkinson’s disease.
  • Augmented management with the addition of key strategic positions to strengthen the Company’s global regulatory, commercial and manufacturing functions including William Regan, Senior Vice President, Global Regulatory Strategy; David Pendleton, Vice President, Marketing and New Product Planning; Stephen Haber, Vice President, Development; and David Casebier, Vice President, Chemistry, Manufacturing and Control.

Pipeline
  • Lymphoseek
    • Designation of April 30, 2013 as a Prescription Drug User Fee Act goal date for Lymphoseek by the U.S. Food and Drug Administration’s (FDA). On September 10, 2012, the Company received a Complete Response Letter (CRL) from the FDA citing manufacturing deficiencies with the Company’s contract manufacturers. The Company stated the CRL was not related to Lymphoseek safety or efficacy, and as a result, was able to quickly resubmit the New Drug Application for Lymphoseek to the FDA on October 30, 2012.
    • Submitted the Lymphoseek Marketing Authorization Application to the European Medicines Agency in December 2012.
    • Reached the interim analysis point of the NEO3-06 Phase 3 head and neck cancer study of Lymphoseek with results from the interim statistical analysis and reporting of the findings expected later in 2013.
    • Initiated a collaboration with Maimonides Medical Center on an investigator-initiated clinical trial utilizing Lymphoseek for lymphatic mapping in colorectal cancer.
    • Presented data from Lymphoseek clinical trials at more than 15 major medical meetings, including: Society of Surgical Oncology, European Society of Surgical Oncology, American Society of Clinical Oncology, Society of Nuclear Medicine, International Conference on Head and Neck Cancer, European Association of Nuclear Medicine, American Society for Radiation Oncology and Radiology Society of North America.
    • Published data from the Lymphoseek Phase 3 Clinical Trial for Intraoperative Lymphatic Mapping of Lymph Nodes in Breast Cancer Compared to Sulfur Colloid and Vital Blue Dye in the Journal of Clinical Oncology Online (2012; e21066).
    • Published results from the Lymphoseek Phase 3 Clinical Trials in Melanoma in the Annals of Surgical Oncology (DOI 10.1245/s10434-012-2612-z).
  • NAV4694
    • Initiated a Phase 2 clinical trial of NAV4694 as an aid in diagnosing Alzheimer’s disease (AD) with the goal to compare images from subjects with probable AD with similarly aged and young healthy volunteers.
    • Presented data from the NAV4694 studies six major neurological medical meetings including: Human Amyloid Imaging meeting, Alzheimer’s Disease Neuroimaging Initiative, Society of Nuclear Medicine and the Alzheimer’s Association International Conference on Alzheimer’s Disease.
  • NAV5001
    • Licensed NAV5001, an Iodine-123 radiolabeled imaging agent being developed as a potential aid in the diagnosis of Parkinson’s disease, dementia with Lewy Bodies (DLB) and other movement disorders, thus expanding the Company’s neuroimaging pipeline.
  • RIGScan
    • Awarded a Small Business Innovation Research grant from the National Institutes of Health for development of a radio-immuno-guided surgery agent aimed at detecting metastatic cancer, with potential for grant money up to a total of $1.5 million over three years if fully funded.

Management Commentary

“Through flexible access to multiple available funding sources, we have maintained a strong financial position in advance of expected revenue from our first radiopharmaceutical product, Lymphoseek,” said Brent Larson, Navidea’s Senior Vice President and CFO. ”We believe that 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. In addition, we have spent considerable effort in 2012 to build relationships with potential institutional investors and catalyze interest in Navidea. As an example, our recent transaction led by J.P. Morgan Asset Management has provided us the opportunity to expand our institutional base with additional outstanding investors.”

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