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May 15, 2014
16:37 EDTNAVBNavidea refocuses resources to align funding of pipeline, names interim CEO
The Board of Directors of Navidea Biopharmaceuticals announced that it is refocusing the company's resources to better align the funding of the pipeline programs with the expected growth in Lymphoseek revenue. To facilitate the refocusing effort, the Board has asked Michael Goldberg, M.D. to serve as interim CEO while a search for a new CEO is conducted. The Navidea Board believes that the market is not currently giving appropriate value to its Phase III pipeline products and is likely penalizing the company for allocating resources to these exciting programs. The company is also working to establish new sources of non-dilutive funding, including collaborations that can augment the balance sheet as the company works to reduce spending to levels that can be more closely offset by growing Lymphoseek revenue. In particular, substantial progress on the Manocept platform has resulted in some very exciting partnering opportunities that will further expand the company's pipeline while requiring much less funding than the two ongoing Phase III programs. Dr. Mark Pykett has agreed to step down from the CEO position, effective on or about May 31, to work full time on maximizing the potential of the Manocept program. Dr. Pykett will also continue to serve as a Director of Navidea until the 2014 Annual Meeting. Navidea remains committed to expanding the Lymphoseek label and realizing the full potential of the product. It intends to work closely with its partners to continue the strong growth of this important product. The company believes that the resources being devoted to drive Lymphoseek sales will eventually provide returns to the point where developmental stage programs can be substantially funded from cash flow from operations. The company is focused on expanding the market for Lymphoseek in all relevant markets. To this end, the Compensation, Nominating and Governance Committee of the Board of Directors has initiated a search for a CEO who will bring experience in global product sales, especially related to expanding the market for commercial products.
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December 15, 2014
13:12 EDTNAVBNavidea's Macrophage unit announces presentation of data using tilmanocept
Macrophage Therapeutics, a newly created business unit of Navidea Biopharmaceuticals, hosted a conference where data was presented using Manocept platform compound, tilmanocept, that was generated by independent academic collaborators with expertise in the HIV/AIDS, cancer, tuberculosis, rheumatoid arthritis and cardiovascular disease therapeutic areas. The technical presentations highlighted tilmanocept’s ability to target activated macrophages implicated in pathology. Specifically data were presented in: 1. Kaposi’s Sarcoma cells from human tumor extracts that contain tumor associated macrophages and are often infected with HIV. Data demonstrated that a generic anticancer agent that has no direct activity vs. HIV, conjugated to tilmanocept killed the CD-206 positive TAM’s. 2. Tilmanocept labeled with a fluorescent reporter demonstrated a high degree of co-localization with tuberculosis-associated activated macrophages, which express CD-206, from TB granulomas extracted from human and primate tissue. 3. Rheumatoid Arthritis - Data presented indicated that tilmanocept containing a florescent reporter molecule demonstrates selective localization solely into rheumatoid affected joints in a whole live animal model of RA. Navidea director Michael M. Goldberg, M.D., who is leading Navidea’s Macrophage Therapeutics efforts, commented, “the data presented today will shortly be enhanced by data from ongoing studies to further advance this novel immunotherapy approach. We are in the process of assembling a world class Scientific Advisory Board that will assist in guiding our research further. We look forward to regularly updating the market with new developments, potential partnerships and results from our ongoing studies.”
09:28 EDTNAVBNavidea trading halted, pending news
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December 10, 2014
07:32 EDTNAVBNavidea forms Macrophage Therapeutics business unit
Navidea Biopharmaceuticals announced the formation of a new business unit, Macrophage Therapeutics, to further explore therapeutic applications for the Manocept platform. The Manocept platform serves as the molecular backbone of Navidea’s FDA-approved, activated macrophage-targeting agent, Lymphoseek injection. Preclinical data being developed by the company using tilmanocept linked to various therapeutic agents suggest that tilmanocept’s binding affinity to CD206 receptors demonstrates the potential for this technology to be useful in treating diseases linked to the over-activation of macrophages. This includes various cancers as well as autoimmune, infectious, cardiovascular, and central nervous system diseases. Navidea intends to structure Macrophage Therapeutics such that it will remain under Navidea’s control enabling existing shareholders to capture potential future value, but also allow funding of future development in a standalone, non-dilutive manner to Navidea’s existing shareholders. Current board members Michael M. Goldberg, M.D. and Eric K. Rowinsky, M.D. and Navidea’s Chief Scientific Officer, Frederick O. Cope, Ph.D. have been appointed to focus on the launch of the new unit.

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