Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results

Rhea-AI Summary

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) reported its financial results for Q4 and full year 2020. Total net revenues increased to $219,000 for Q4, up from $119,000 in 2019, and $914,000 for the full year, compared to $651,000 the previous year. Key achievements included completing the NAV3-31 Phase 2B trial and submitting a briefing book to the FDA. R&D expenses decreased to $1.3 million in Q4 from $1.7 million in 2019, while SG&A expenses rose to $1.7 million. The company is advancing its RA program and opened enrollment for the NAV3-32 trial.

Positive

• Increased total net revenues for Q4 2020 to $219,000 from $119,000 in Q4 2019.
• Achieved positive results in NAV3-31 Phase 2B trial and submitted a briefing book to the FDA.
• Opened enrollment for NAV3-32 Phase 2B trial exploring Tc99m tilmanocept imaging.
• Patent grants from USPTO for significant diagnostic and therapeutic compositions.

Negative

• SG&A expenses increased to $1.7 million in Q4 2020 from $1.2 million in Q4 2019.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and full year for the period ended December 31, 2020.

“We are very excited about the progress we have made, completing all the patients in the Phase 2B NAV3-31 trial and submitting our briefing book to the FDA were milestone accomplishments this past year,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “We are looking forward to hearing back from the FDA and continuing our due diligence discussions with Jubilant over the near term.”

Fourth Quarter 2020 Highlights and Subsequent Events

• Announced positive results from continued analysis of subjects who have completed Arm 3 of the Company’s NAV3-31 Phase 2B study. These data further corroborated Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active rheumatoid arthritis (“RA”) and that this imaging can provide an early indicator of treatment efficacy.
• Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration (“FDA”). The FDA granted the Type B meeting and the Company has submitted the Briefing Book. The FDA is currently reviewing these formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol.
• 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, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA.
• 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 notice of patent grant from the USPTO for US 10,806,803: “Compositions for targeting macrophages and other CD206 high expressing cells and methods of treating and diagnosis.”
• Received a notice of allowance from the USPTO for the patent application: “Compounds and methods for diagnosis and treatment of viral infections” (US Patent Application 15/729,635).
• Performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state and a synergistic effect on tumor growth reduction using the Company’s doxorubicin-containing construct with an approved checkpoint inhibitor therapy.
• Appointed Malcolm G. Witter to the Company’s Board of Directors. Mr. Witter brings decades of financial and corporate governance experience to the board.
• 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.

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 have completed all patients and all visits in our NAV3-31 Phase 2B trial and we are eagerly anticipating feedback from the FDA on our briefing package and design of the Phase 3 trial. We continue to prepare for initiation of this trial and have also opened up enrollment for the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we have made exciting progress in our therapeutics pipeline and will continue to advance these towards the clinic.”

Financial Results

• Total net revenues for the fourth quarter 2020 were $219,000, compared to $119,000 for the same period in 2019. Total net revenues for the full year of 2020 were $914,000, compared to $651,000 for 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 coupled with increased license revenue from net transitional sales in Europe.
• Research and development (“R&D”) expenses for the fourth quarter of 2020 were $1.3 million, compared to $1.7 million in the same period in 2019. R&D expenses for the full year of 2020 were $4.9 million, compared to $5.3 million in the same period in 2019. The decreases were primarily due to net decreases in drug project expenses, including decreased Manocept therapeutic development costs, decreased Manocept diagnostic development costs, and decreased Tc99m development costs, offset by increased NAV4694 development costs. The net decreases also included decreased regulatory consulting and travel expenses offset by increased employee compensation.
• Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2020 were $1.7 million, compared to $1.2 million in the same period in 2019. SG&A expenses for the full year of 2020 were $6.7 million, compared to $6.3 million in 2019. The net increases were primarily due to increased legal and professional services, employee compensation, European Medicines Agency annual fees for Lymphoseek, and franchise taxes, offset by decreased travel, depreciati

FAQ

What were Navidea's financial results for Q4 2020?

Navidea reported total net revenues of $219,000 in Q4 2020, up from $119,000 in Q4 2019.

What clinical trials has Navidea completed recently?

Navidea completed all patients in the NAV3-31 Phase 2B trial and opened enrollment for the NAV3-32 trial.

What is the stock symbol for Navidea Biopharmaceuticals?

The stock symbol for Navidea Biopharmaceuticals is NAVB.

What significant milestones did Navidea achieve in 2020?

Navidea completed the NAV3-31 Phase 2B trial and submitted a briefing book to the FDA for review.

How did Navidea's revenue in 2020 compare to 2019?

Total net revenues for 2020 were $914,000, compared to $651,000 in 2019.