Navidea Biopharma (NYSE: NAVB) reported Q1 EPS of ($0.11), $0.03 worse than the analyst estimate of ($0.08). Revenue for the quarter came in at $123.74 thousand versus the consensus estimate of $600 thousand.

First Quarter 2021 Highlights and Subsequent Events

• Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration (“FDA”). The FDA granted the Type B Meeting and reviewed the formal briefing documents Navidea submitted containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol. Following the feedback received from the FDA at the end of March 2021, the Company continues to work toward completing the analysis of the full trial dataset in preparation for the standard End of Phase 2 Type B meeting and in preparation for the Phase 3 study.
• Achieved last patient, last visit in the Company’s NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
• Opened the first US site, Northwestern University, as well as the primary UK site, Queen Mary University of London, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active rheumatoid arthritis (“RA”).
• Opened the NAV3-35 trial to establish a normative database of healthy controls for Tc99m tilmanocept imaging in rheumatoid arthritis.
• Continued enrollment in the Investigator-Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
• Received a notice of allowance from the United States Patent and Trademark Office for the patent application: “Compounds and methods for diagnosis and treatment of viral infections” (U.S. Patent Application 15/729,635).
• Announced that the results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science’s (“NYAS”) Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, “Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4.”
• Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the “Series E Preferred Stock”) for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.
• Appointed Amit Bhalla to the Company’s Board of Directors. Mr. Bhalla brings a wealth of financial experience to the board.

“We are continuing a positive dialogue with the FDA and are moving as quickly as we can to fully document all the data from Arm 3 of NAV3-31,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “We are also excited to begin patient enrollment for NAV3-32 both here in the U.S. and in the UK.”

Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, “The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We are completing the analysis of the full dataset from the NAV3-31 Phase 2B trial as well as planning for the Phase 3 trial. We continue to prepare for initiation of this trial and have opened up key sites for enrollment into the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, some of which will be presented this month at the NYAS conference, and we expect to continue to advance these towards the clinic.”

For earnings history and earnings-related data on Navidea Biopharma (NAVB) click here.