Navidea Biopharm Stock Price, News & Analysis

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has appointed Michel Mikhail, Ph.D., as Chief Regulatory Officer effective October 1, 2021. Dr. Mikhail brings over 30 years of experience in regulatory affairs from his roles at various multinational pharmaceutical companies. His expertise includes navigating drug development through regulatory processes. Navidea's Chief Executive Officer, Jed Latkin, expressed enthusiasm about Dr. Mikhail's leadership to advance their Manocept platform for improved patient care. The company is focused on developing precision diagnostic agents.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced changes in its Board of Directors. On September 14, 2021, Dr. S. Kathryn Rouan retired as Chair, with Claudine Bruck also stepping down as a director. Alexander L. Cappello was appointed as the new Chair, while John K. Scott became Vice Chair. Additionally, Cappello joined the Audit Committee, enhancing its leadership role. CEO Jed Latkin expressed gratitude to the retiring directors for their contributions, highlighting a combined 60 years of experience in the clinical field.

Navidea Biopharmaceuticals (NAVB) reported Q2 2021 net revenues of $261,000, a decline from $271,000 in Q2 2020. Year-to-date revenues also fell to $385,000 from $427,000. The company’s R&D expenses increased to $1.5 million in Q2 2021, compared to $1.3 million in Q2 2020. Net loss for Q2 2021 was $2.7 million or $0.09 per share, versus $2.4 million or $0.11 per share in the same quarter last year. Navidea is preparing for a crucial FDA meeting on September 1, 2021, and has strengthened its board with three new appointments.

Navidea Biopharmaceuticals (NYSE American: NAVB) will host a conference call on August 11, 2021, at 5:00 p.m. EDT to discuss Q2 2021 financial results and corporate developments. CEO Jed Latkin, CMO Dr. Michael Rosol, and VP Erika Eves will present the information and answer questions. The call can be accessed via conference dial-ins and a live webcast on Navidea's website. This session aims to provide updates on Navidea's precision immunodiagnostic agents and immunotherapeutics development, focusing on financial performance and clinical progress.

Navidea Biopharmaceuticals (NYSE American: NAVB) announced the enrollment of over 110 subjects in its NAV3-35 Phase 2b study aimed at creating a normative database for rheumatoid arthritis (RA) imaging using Tc99m tilmanocept. The trial's target is 135 participants, with a focus on differentiating RA-inflamed joints from healthy ones. The database will enhance automated image analysis for improved accuracy. Dr. Michael Rosol emphasized its critical role in future data analysis and commercialization, while CEO Jed Latkin noted the rapid enrollment reflects the company's commitment to advancing RA diagnostic products.

Navidea Biopharmaceuticals (NYSE American: NAVB) announced that the FDA has granted a meeting to discuss the advancement of its Rheumatoid Arthritis (RA) program to a pivotal Phase 3 trial. Scheduled for September 1, 2021, the meeting will focus on results from the Phase 2b NAV3-31 study and the proposed Phase 3 trial protocol. Interim analyses indicated that Tc99m tilmanocept imaging could serve as an early indicator of treatment response in RA patients. This development could significantly benefit over 1.3 million RA patients in the U.S. by providing a noninvasive method for monitoring treatment efficacy.

Navidea Biopharmaceuticals (NYSE American: NAVB) announced a court ruling on June 23, 2021, in favor of its subsidiary Macrophage Therapeutics against former CEO Dr. Michael Goldberg. The Delaware Court found that Dr. Goldberg breached his fiduciary duties to MT by attempting to misappropriate intellectual property. Although the Court awarded nominal damages, it rejected MT's claims for conversion and denied Goldberg's motions to hold MT's directors in contempt or dismiss the lawsuit. This ruling reinforces MT's legal standing and addresses past governance issues.

Navidea Biopharmaceuticals announced the issuance of U.S. patent 11,007,272, protecting its mannosylated dextran-based drug delivery vehicles for treating viral infections, effective until October 7, 2037. The patent targets flaviviruses, including those causing dengue, yellow fever, and Zika, which together affect an estimated 100-400 million individuals annually. This innovation aims to address significant medical needs and may extend to other diseases, such as HIV and hepatitis C.

Navidea Biopharmaceuticals (NAVB) announced its Q1 2021 financial results, reporting total net revenues of $124,000, down from $156,000 in Q1 2020. The net loss for the quarter was $3 million, or $0.11 per share. R&D expenses increased to $1.2 million, driven by higher development costs. Despite these challenges, the company is advancing its clinical trials, including NAV3-32 in rheumatoid arthritis, while engaging positively with the FDA. Notably, it secured a $5 million investment through a stock purchase agreement.