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

DUBLIN, Ohio–(BUSINESS WIRE)–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.

Michael Rosol, Chief Medical Officer for Navidea, said, “We are excited
to present the results from our Phase 1/2 study demonstrating
joint-specific localization to inflamed joints of RA subjects when
compared to healthy controls, as well as determining the optimum
clinical dose for imaging with Tc99m tilmanocept in RA.” Dr. Rosol
continued, “These results have provided support to our initiative for
the currently running follow-on Phase 2B, as well as our next upcoming
Phase 2B and the Phase 3 study intended to garner FDA approval of new
indications for Tc99m tilmanocept in RA patients. We are very pleased
that enrollment of our first Phase 2B has begun and is proceeding well.”

Bonnie Abbruzzese, Navidea’s Senior Director, Clinical Research, said,
“We are pleased that subject recruitment for our Phase 2B has started
off at a good pace, and the entire clinical team is working hard to
continue to open additional sites as well as to monitor continued
subject recruitment. The study results to be presented at SNMMI laid the
groundwork for this latest trial, and we are looking forward to seeing
the results presented in Anaheim.”

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.

Reference

1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE American: 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. 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 efforts.

For more information, please visit www.navidea.com.

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Contacts

Navidea Biopharmaceuticals, Inc.
Jed Latkin, CEO, 614-973-7490
jlatkin@navidea.com