On May 11, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter for the period ended March 31, 2021 (Press release, Navidea Biopharmaceuticals, MAY 11, 2021, View Source [SID1234579718]).

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"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."

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.
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."

Financial Results

Total net revenues for the first quarter of 2021 were $124,000, compared to $156,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development, offset by the partial recovery in the first quarter of 2021 of debts previously written off in 2015.
Research and development expenses for the first quarter of 2021 were $1.2 million, compared to $999,000 in the same period in 2020. The increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic and therapeutic development costs and increased Tc99m development costs, offset by decreased employee compensation.
Selling, general and administrative expenses for the first quarter of 2021 were $2.2 million, compared to $1.8 million in the same period in 2020. The net increase was primarily due to increased legal and professional services, insurance, investor relations services, and employee compensation, offset by decreased franchise taxes.
Navidea’s net loss attributable to common stockholders for the first quarter of 2021 was $3.0 million, or $0.11 per share, compared to $2.7 million, or $0.13 per share, for the same period in 2020.
Navidea ended the first quarter of 2021 with $7.5 million in cash and cash equivalents.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.D:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.