Navidea Receives $1.1M PDUFA Filing Fee Refund For Award Of Orphan Drug Status; Platinum Partners Reaffirms Commitment To Line Of Credit

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) today announced it has received a $1.1 million refund of the previously paid Prescription Drug User Fee Act (PDUFA) filing fee related to the granting of orphan drug status of Lymphoseek® (technetium Tc 99m tilmanocept) injection in head and neck cancers. Lymphoseek was granted Orphan Drug Designation by the FDA in September 2014 for use in sentinel lymph node detection in patients with cancer of the head and neck. Additionally, Platinum Partners, Navidea's major investor, reaffirmed its support of the Company through the remaining $31.8 million available under the previously announced line of credit. “We share Navidea's belief in Lymphoseek's commercial potential and the diagnostic and therapeutic promise of the Manocept™ platform,” said Mark Nordlicht, Chief Investment Officer, Platinum Partners. “Following recent regulatory approvals and the hiring of Rick Gonzalez as CEO, we are fully committed to providing the organization with access to the outstanding line of credit. While Platinum believes the Company's financial strength will improve with each day's sales under the new broader label, we are confident this funding vehicle is in the best interest of shareholders and access to it, to the extent that it becomes necessary, can minimize Navidea's cost of capital.” “We believe we have sufficient capital resources to attain our immediate goals and realize the full commercial potential for Lymphoseek,” said Rick Gonzalez, Navidea Chief Executive Officer. “We are in a position to manage our available cash with our expected growth in revenue and gross profit, our ability to further reduce our operating costs and, if needed, our access to capital under the line of credit from Platinum Partners.” The original line of credit was executed on July 26, 2012 with Platinum Partners, (formerly Platinum-Montaur Life Sciences, LLC). Under the terms of the transaction, Platinum Partners originally committed to extend up to $15 million in debt immediately to the Company, with an additional $20 million which became committed upon approval of Lymphoseek, and yet an additional $15 million potentially available on terms to be negotiated. To date, the Company has drawn $3.2 million under the credit facility. No conversion features or warrants are associated with the facility.