Market Overview

Navidea Biopharmaceuticals Data to be Presented at Society of Nuclear Medicine and Molecular Imaging Annual Meeting


Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the
"Company"), a company focused on the development of precision
immunodiagnostic agents and immunotherapeutics, today announced that
Arash Kardan, M.D., will give an oral presentation on the results of the
Company's NAV3-21 clinical study at the Society of Nuclear Medicine and
Molecular Imaging ("SNMMI") Annual Meeting in June 2019. The
presentation is titled "A Phase I/Phase II Study of Intravenously ("IV")
Administered Tc99m Tilmanocept ("TCT") to Determine Safety,
Tolerability, Optimal Clinical Dose Selection, and Imaging Timepoint in
Patients Clinically Diagnosed with Rheumatoid Arthritis ("RA")." In
addition, an abstract of the presentation will be published in the Journal
of Nuclear Medicine

The NAV3-21 study enrolled subjects with active, moderate-to-severe RA
and healthy controls. Images were acquired one hour and three hours
post-injection of Tc99m tilmanocept. Results from the completed trial
demonstrate that Tc99m tilmanocept is well-tolerated with no serious
adverse events, adverse drug reactions, or drug-related adverse events
observed. Additionally, static planar images revealed joint-specific
Tc99m tilmanocept localization in RA subjects to disease-involved joints
of the shoulders, knees, hands, and feet, but no joint-specific
localization in healthy control subjects, revealing potentially
significant immunodiagnostic information about CD206-expressing synovial
macrophage involvement in RA. Enhanced anatomic delineation in
tilmanocept-positive joints of RA patients was noted via IV
administration in this trial when compared to subcutaneous
administration of Tc99m tilmanocept studied in a previously-completed
Phase 1 trial.

Michael Rosol, Chief Medical Officer for Navidea, said, "Using
noninvasive planar imaging and SPECT/CT with Tc99m tilmanocept we can,
for the first time, objectively visualize and directly quantify RA
disease activity and evaluate joint-specific inflammation. This could
also enable noninvasive characterization of joint-level pathobiology and
individualization of treatment." Dr. Rosol continued, "The results from
this and our previously completed RA trial support our initiative for
follow-on Phase 2b and Phase 3 studies intended to garner FDA approval
of new indications for Tc99m tilmanocept in RA patients."

RA is a chronic disease affecting over 1.3 million Americans and as much
as 1% of the worldwide population.1 If the product is
successfully developed, Navidea would expect to play a major role in the
management of RA patients worldwide.

Additional information can be found at



About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE: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

For more information, please visit

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