On November 12, 2020 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 third quarter and year-to-date for the period ended September 30, 2020 (Press release, Navidea Biopharmaceuticals, NOV 12, 2020, View Source [SID1234570811]).
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"Navidea continues to build on its clinical momentum and this quarter fully shows our ability to execute during a very trying time globally," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The due diligence continues with Jubilant and the Phase 2b is nearing its conclusion. We are very excited to move forward and present to the FDA in the near future."
Third Quarter 2020 Highlights and Subsequent Events
Executed a binding memorandum of understanding ("MOU") on August 9, 2020 with Jubilant Draximage Inc. dba Jubilant Radiopharma, Radiopharmaceuticals Division ("Jubilant"). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s Rheumatoid Arthritis Diagnostic in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.
Entered into a Stock Purchase Agreement with investors, pursuant to which the investors agreed to purchase up to $25.0 million in shares of the Company’s Common Stock.
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company agreed to issue to the investor 150,000 shares of newly-designated Series D Redeemable Convertible Preferred Stock (the "Series D Preferred Stock") for an aggregate purchase price of $15.0 million. Pursuant to the Series D Preferred Stock Purchase Agreement, Keystone will purchase Series D Preferred Stock in amounts to be determined by Keystone in one or more closings during the nine-month period following the date on which the prospectus supplement to register the underlying Common Stock was filed with the SEC, provided that all of the Series D Preferred Stock must be purchased by such date. The Series D Preferred Stock will be convertible into a maximum of 5,147,000 shares of Common Stock.
Announced acceptance by the American College of Rheumatology ("ACR") of the results from the Company’s second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting ("ACR Convergence 2020") under the title, "Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy."
Continued longitudinal imaging and clinical assessments of Arm 3 subjects, who are beginning new anti-TNFα therapy, in the NAV3-31 trial.
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.
Converted a provisional patent on blocking off-target organ uptake of Tilmanocept to improve on-target localization.
Received a one-year extension on its NIH phase 1 Small Business Technology Transfer grant (1R41HL147640-01A1) entitled Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques, due to COVID-19 related shutdown of the research facility at the University of Alabama Birmingham. The site has reopened and these preclinical studies are ongoing.
Won dismissal of Platinum-Montaur Life Sciences LLC’s lawsuit against the Company.
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. The currently running Phase 2b trial in RA is proceeding well, with Arm 3 subjects having their later imaging and clinical assessments. Preparation of the package to discuss with the FDA in planning for the upcoming Phase 3 is nearing completion. We are also preparing for the start of our second Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients."
Financial Results
Total revenues for the third quarter 2020 were $268,000, compared to $237,000 for the same period in 2019. Total revenues for the first nine months of 2020 were $696,000, compared to $539,000 for the same period in 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development.
Research and development ("R&D") expenses for the third quarter of 2020 were $1.4 million, compared to $1.8 million in the same period in 2019. The third quarter decrease was primarily due to net decreases in drug project expenses, including decreased Manocept diagnostic and Tc99m tilmanocept development costs, coupled with decreased employee compensation. R&D expenses for the first nine months of 2020 were $3.7 million, compared to $3.6 million in the same period in 2019. The year-to-date increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic development costs offset by decreased Manocept therapeutic and Tc99m tilmanocept development costs, coupled with increased employee compensation.
Selling, general and administrative ("SG&A") expenses for the third quarter of 2020 were $1.8 million, compared to $1.5 million in the same period in 2019. The third quarter increase was primarily due to increased legal and professional services and employee compensation, offset by decreased travel, insurance, and depreciation costs. SG&A expenses for the first nine months of 2020 were $4.9 million, compared to $5.1 million in the same period in 2019. The year-to-date decrease was primarily due to decreased travel, legal and professional services, insurance, depreciation, and investor relations costs, offset by increased employee compensation and franchise taxes.
Navidea’s net loss attributable to common stockholders for the third quarter of 2020 was $3.3 million, or $0.13 per share, compared to $3.1 million, or $0.17 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the first nine months of 2020 was $8.4 million, or $0.37 per share, compared to $8.2 million, or $0.62 per share, for the same period in 2019.
Navidea ended the third quarter of 2020 with $3.7 million in cash and cash equivalents. Since September 30, 2020, the Company has received $700,000 of cash related to the August 2020 funding transactions.
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.
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.