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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) announced the retirement of Michael Rice and Adam Cutler from its Board of Directors. Dr. Kathy Rouan has been appointed as the new Chair of the Board, with Amit Bhalla joining as a new board member. Bhalla brings extensive experience from his role as CFO at Infinity BiologiX and prior leadership positions in various healthcare firms. CEO Jed Latkin expressed gratitude for the departing members and excitement for Bhalla's contribution to the company, highlighting his diverse financial and operational background.
Navidea Biopharmaceuticals (NYSE American: NAVB) will host a conference call on May 11, 2021, at 5:00 p.m. EDT to discuss its Q1 financial results and corporate developments. CEO Jed Latkin, CMO Dr. Michael Rosol, and CBO Joel Kaufman will lead the call, addressing financials and clinical progress. Investors can join via dial-in or webcast, with additional access to a recorded replay available for 90 days. Navidea focuses on precision immunodiagnostic agents and therapeutics, leveraging its Manocept platform to improve diagnostic accuracy and treatment.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced preclinical study results of its targeted cancer immunotherapeutic agent, showcased at the NYAS Frontiers in Cancer Immunotherapy Symposium 2021. The agent, Man-Dox, combines doxorubicin with a mannosylated dextran backbone, effectively altering tumor-associated macrophages (TAMs) to a pro-inflammatory state. In mouse models, it showed significant tumor growth inhibition when combined with anti-CTLA4 therapy. This success supports further studies toward an FDA IND application for human trials.
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.
Navidea Biopharmaceuticals (NYSE American: NAVB) announced a conference call scheduled for March 24, 2021, at 5:00 p.m. EDT to discuss its financial results for Q4 2020. Key executives including CEO Jed Latkin and CMO Dr. Michael Rosol will provide updates on financial performance and clinical progress. A live audio webcast will be accessible on the company’s investor relations page, and a recorded replay will be available for 90 days post-call. Navidea continues to focus on developing precision immunodiagnostic agents through its Manocept platform.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced its participation in the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, 2021. Management will present a company overview and hold virtual meetings with investors. The presentation will be accessible after registering for the conference. The company is focused on developing precision immunodiagnostic agents and immunotherapeutics through its Manocept™ platform, aimed at enhancing patient care and diagnostic accuracy. For more details, visit www.navidea.com.
Navidea Biopharmaceuticals (NYSE American: NAVB) has entered an agreement with its largest shareholder, John K. Scott, Jr., to purchase $5 million in Series E Redeemable Convertible Preferred Stock. This financing allows for conversion into approximately 2.17 million shares of common stock over the next 18 months. CEO Jed Latkin emphasized this support strengthens the company's balance sheet and accelerates its therapeutics pipeline. Scott, who has been a shareholder since 2003, affirmed his belief in Navidea’s drug candidates and their potential benefits.
Navidea Biopharmaceuticals (NYSE American: NAVB) has submitted a Type B Meeting Request to the FDA, which has been granted. The FDA will review Navidea's briefing documents related to the NAV3-31 Phase 2B study results and a proposed Phase 3 trial protocol. This pivotal Phase 3 trial aims to evaluate Tc99m tilmanocept imaging as an early predictor of treatment response in Rheumatoid Arthritis (RA) patients. The company has also opened its first U.S. site for the NAV3-32 Phase 2B trial, further advancing its RA program.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced its participation in the 2021 ICR Conference on January 14, 2021, at 2:30 p.m. EST. The conference will feature CEO Jed Latkin and CBO Joel Kaufman. A live video webcast of the presentation will be available, and a replay will be accessible for one year. Navidea focuses on developing precision immunodiagnostic agents via its Manocept™ platform, designed to enhance patient care and improve diagnostic accuracy. For more information, visit www.navidea.com.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced the appointment of Malcolm G. Witter to its Board of Directors. With decades of experience in financial and corporate governance, Witter currently leads corporate development at USI Insurance Services. He has held positions at Bear Stearns, EF Hutton, and Dean Witter, and earned his MBA from Stanford. CEO Jed Latkin expressed confidence in Witter's expertise in M&A and corporate finance to help guide the company in its future developments.
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