Navidea Biopharmaceuticals, Inc. announced disappointing results of an exploratory analysis conducted on the Company?s pivotal NAV3-33 clinical trial titled ?Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)? (ClinicalTrials.gov Identifier: NCT05246280) the ?RA Trial.? The purpose of the exploratory analysis was to optimize the diagnostic performance in support of the methodologies to be applied in the final pivotal trial.

The results confirm that intravenous Tc 99m tilmanocept can target and produce reliable images of macrophage activity in RA patients, but that these images do not adequately predict which patients will respond to treatment with an anti-TNF alpha medication. Given these results, Navidea is suspending all activities related to the RA Trial. The Company is pivoting to focus on exploring all opportunities related to the Company?s therapeutic assets.