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NAVIDEA BIOPHARMACEUTICALS, INC. (symbol: NAVB) is a prominent biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. The company operates through two main segments: Diagnostic Substances and Therapeutic Development Programs.
At the heart of Navidea's innovation is the Manocept Platform, designed to target the CD206 mannose receptor expressed on activated macrophages. This platform has broad applications across various diagnostic modalities, including Single Photon Emission Computed Tomography (SPECT), Positron Emission Tomography (PET), imaging, and topical gamma-scanning. Additionally, it facilitates intra-operative and/or optical-fluorescence detection, and the delivery of therapeutic compounds targeting macrophages and diseases involving immune and inflammation responses.
Navidea's product portfolio features NAV4694, a fluorine-18 labeled PET imaging agent used for imaging and evaluating patients exhibiting signs of Alzheimer's disease and mild cognitive impairment. This product underscores the company's commitment to addressing urgent medical needs through advanced diagnostics.
In terms of current projects and partnerships, Navidea continues to build strategic alliances to enhance its product offerings and broaden its market reach. Financially, the company remains focused on strategic investments and operational efficiencies to bolster its position in the biopharmaceutical sector.
Navidea Biopharmaceuticals (NYSE American: NAVB) has announced the commencement of its rights offering subscription period. Rights holders must act quickly, as the deadline to exercise these rights is August 17, 2022, by 5:00 PM Eastern Time. Each subscription right allows the purchase of a unit for $1,000, including one share of Series I Convertible Preferred Stock and a warrant for 1,538 shares of common stock at an exercise price of $0.70. Maxim Group LLC will manage the offering, with further financial results expected on August 15, 2022.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced the publication of a study showcasing Tc99m tilmanocept as an effective tracer for lymphatic mapping in melanoma and oral cancer. Conducted at the Crown Princess Mary Cancer Centre, the study involved 35 patients and reported a 100% sensitivity and intraoperative retrieval rate for sentinel lymph nodes. The findings support Tc99m tilmanocept's reliability as a radiotracer, enhancing the precision of cancer staging. The study's success highlights the potential for further expansion of Lymphoseek beyond North America.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced the publication of a manuscript regarding its Tc99m tilmanocept imaging study. Conducted at Massachusetts General Hospital and Harvard Medical School, the research highlights increased macrophage-specific arterial inflammation in HIV patients on anti-retroviral therapy compared to matched controls. Results showed significant arterial inflammation in HIV patients, linking it to non-calcified plaque and specific immune activation pathways. This study suggests potential applications of Tc99m tilmanocept in monitoring cardiovascular risks in HIV treatment.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced its upcoming rights offering, allowing stockholders of record as of August 3, 2022 to participate. Each stockholder will receive a non-transferable subscription right to purchase one unit at a price of
Navidea Biopharmaceuticals (NYSE American: NAVB) announced on July 1, 2022, that its largest shareholder, John K. Scott, Jr., provided an additional $1.0 million funding via a secured bridge loan executed on April 10, 2022. Dr. Michael Rosol, Chief Medical Officer, expressed enthusiasm for the continued funding to support Phase 3 and R&D efforts. Navidea focuses on precision immunodiagnostic agents and immunotherapeutics, utilizing its Manocept™ platform to improve diagnostic accuracy and treatment targeting.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced the acceptance of its abstract for presentation at the SNMMI Annual Meeting in Vancouver, Canada, from June 11-14. The abstract focuses on TAM-targeted imaging agents for tumor localization, developed in collaboration with the University of Alabama at Birmingham. The research aims to improve tumor imaging while reducing liver localization, showcasing promising results with new imaging agents labeled with gallium-68. This presentation highlights Navidea's commitment to advancing medical imaging and potential therapeutic strategies.
Navidea Biopharmaceuticals (AMEX: NAVB) announced the acceptance of its abstract for a poster presentation at the Tumor Myeloid-Directed Therapies Summit scheduled for June 14-16, 2022, in Boston, MA. The poster will highlight new bisphosphonate drug constructs developed using Navidea’s CD206-targeted drug delivery platform, Manocept. These constructs successfully shifted human macrophage phenotypes towards a proinflammatory state and significantly reduced SIRPα expression, which may enhance cancer immunotherapy applications. Chief Medical Officer Dr. Michael Rosol emphasized the potential of these constructs in treating severe illnesses.
Navidea Biopharmaceuticals, focused on precision immunodiagnostic agents, reported its Q1 2022 financial results. Total net revenues were $0, down from $124,000 in Q1 2021 due to previous debt recovery and license revenue. Net loss attributable to common stockholders was $3.0 million, or $0.10 per share, stable compared to $3.0 million, or $0.11 per share in 2021. Positive developments included ongoing Phase 3 and 2b trials for rheumatoid arthritis, regulatory approval for Lymphoaim in India, and new provisional patent applications, indicating progress in their pipeline. Investors can join the upcoming conference call for more insights.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is scheduled to hold a conference call on May 12, 2022, at 5:00 p.m. (EDT), to discuss its first quarter financial results and corporate developments. The call will feature Dr. Michael Rosol and Erika Eves, who will provide insights on financial performance and clinical progress. Investors can access the call via a web link and will have the opportunity to ask questions following the announcement. The company aims to enhance patient care through its innovative Manocept™ platform.
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