Navidea Biopharmaceuticals Announces Day and Time of SNMMI Presentation of Phase 1/2 Study Results and Enrollment Update on its Phase 2B Study

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce the details of 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 Anaheim, CA. The presentation, 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”)" will be delivered at 12:30 PM, Sunday, June 23, 2019 by Arash Kardan, M.D. In addition, an abstract of the presentation will be published in a future edition of the Journal of Nuclear Medicine.

The NAV3-21 study enrolled subjects with active, moderate-to-severe RA, and healthy controls. 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. An optimal imaging time window post-Tc99m tilmanocept IV administration, as well as optimal dosing, were also determined.

Navidea’s Phase 2B study, titled “Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (“TUV”) on Tc 99m Tilmanocept Planar Imaging” is ongoing. Two sites are now open for recruitment and the first four patients have been enrolled into the study. It is anticipated that two more sites will be opened shortly. This study is designed to evaluate the reliability and sensitivity of assessments in both healthy controls and in subjects with active RA. The study is stratified into three arms, with the first two arms consisting of [1] disease-free healthy controls and [2] clinically diagnosed RA subjects on stable treatment. The third arm is designed to assess the efficacy of TUV global in clinically diagnosed subjects with active RA and will power the upcoming pivotal Phase 3 trial.