DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) (“Navidea” or “the Company”), a company focused on the development and commercialization of precision immunodiagnostic agents, today announced its financial results for the first quarter of 2017. Navidea reported total revenue (excluding discontinued operations) for the quarter of $580,000. Net income attributable to common stockholders was $85.6 million.
“Navidea ended the first quarter with strong momentum built upon the strategic plan developed over the past two quarters. Our strategy is designed to maximize the value of our proprietary macrophage-targeting technology by developing and out-licensing promising imaging and therapeutic products,” said Michael Goldberg, M.D., Navidea’s President and CEO. Dr. Goldberg continued, “Our completed sale of the North American rights to Lymphoseek® to Cardinal Health 414, LLC ensures that our focus remains on product development going forward. We are confident that our Manocept platform, properly developed, will yield both diagnostics and therapeutics that can generate significant value for our stockholders.”
Product, Pipeline, and Business Updates
Lymphoseek®
- On March 3, 2017, Navidea completed the sale of the North American rights to Lymphoseek® to Cardinal Health 414, receiving approximately $82 million at closing.
- Navidea will have the opportunity to earn up to $227 million of additional consideration through 2026, with $17.1 million guaranteed over the next three years.
- As a result of this closing, all liens on Navidea’s assets have been released, all frozen accounts have been transferred to Navidea’s control, and the majority of the loan from Platinum Partners has been repaid.
Manocept Immunodiagnostic Pipeline
The flexible and versatile Manocept platform acts as an engine for the design of targeted imaging molecules applicable to a range of diagnostic modalities, including single photon emission computed tomography (“SPECT”), positron emission tomography (“PET”), gamma-scanning (both imaging and topical) and intra-operative and/or optical-fluorescence detection. We have active clinical diagnostic programs in cardiovascular disease, rheumatoid arthritis, Kaposi’s sarcoma and colorectal cancer, diseases representing both major macrophage activation states.
Cardiovascular Disease – The results of a study to evaluate diagnostic imaging of emerging atherosclerosis plaque with Tc 99m tilmanocept were published in early release in the Journal of Infectious Diseases on January 16, 2017, confirming that the Tc 99m tilmanocept product can both quantitatively and qualitatively target non-calcified plaque in the aortic arch.
Colorectal Cancer and Synchronous Liver Metastases – During the first quarter of 2017, we initiated an imaging study in subjects with colorectal cancer and liver metastases via intravenous administration of Tc 99m tilmanocept.
Manocept Immunotherapeutic Development Pipeline (Macrophage Therapeutics)
Navidea’s majority-owned subsidiary, Macrophage Therapeutics, Inc. (“MT”), has developed processes for producing the first two therapeutic Manocept immunoconstructs consisting of a therapeutic molecule conjugated to moieties targeting CD206+ macrophages:
- MT-1002, designed to specifically target and kill activated CD206+ macrophages by delivering doxorubicin; and
- MT-2002, designed to inhibit the inflammatory activity of activated CD206+ macrophages by delivering a potent anti-inflammatory agent.
In the first quarter of 2017, MT completed its third vivo study dosing either MT-1002 or MT-2002 in a well-established mouse model of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis and liver fibrosis, in which both compounds significantly reduced key disease parameters.
Also in the first quarter of 2017, we completed a series of predictive in vitro screening tests of the MT-1002 and MT-2002 therapeutic conjugates against the Zika and Dengue viruses and against Leishmaniosis. These evaluations were positive and MT will begin in vivo testing in the second or third quarter of 2017.
