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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) will host a conference call on
Navidea Biopharmaceuticals (NYSE American: NAVB) has announced that results from its preclinical studies on targeted immunotherapy using the Manocept platform will be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer in Boston from November 8-12, 2022. The abstract titled, “Synthetic CD206 Targeted Constructs Carrying Paclitaxel or Novel Bisphosphonate Payloads Alter Macrophages Towards Pro-inflammatory Phenotypes,” will be presented on November 10. This presentation underscores Navidea's ongoing commitment to developing innovative immunotherapies for cancer.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) appointed Joshua Wilson to its Board of Directors effective September 30, 2022. Wilson brings over 23 years of banking and finance experience, having raised more than $500 million for various entities. He is currently CEO of UpSwing Foundation and Executive Director of G2G Ventures. Navidea also announced the date for its 2022 Annual Meeting of Stockholders, scheduled for December 8, 2022. Shareholders must submit proposals by October 10, 2022, to be considered during the meeting.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced that it will present results from its NAV3-31 and NAV3-32 Phase 2B clinical studies at the American College of Rheumatology Annual Meeting from November 10-14, 2022. The NAV3-31 study demonstrated that Tc99m tilmanocept imaging accurately predicts clinical response in rheumatoid arthritis (RA) patients on anti-TNFα therapy, achieving high specificity and predictive value. Preliminary results from the NAV3-32 study indicate a correlation between TIL uptake and macrophage involvement, potentially aiding personalized treatment decisions for RA patients.
Navidea Biopharmaceuticals, Inc. (NAVB) has announced the opening of nine new sites for its pivotal NAV3-33 Phase 3 clinical trial focused on utilizing Tc99m tilmanocept imaging to predict the response to anti-TNFα therapy in patients with moderate to severe rheumatoid arthritis (RA). This trial aims to expedite patient enrollment and improve treatment outcomes by offering a noninvasive method to assess treatment efficacy sooner. Additionally, the company has terminated its Memorandum of Understanding with Jubilant Radiopharma, enabling new partnership opportunities.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced a court ruling on August 30, 2022, from the District Court of Harris County, Texas. The court awarded Capital Royalty Group $2,572,937.61 in attorney’s fees for breach of contract claims. Navidea expressed disappointment with the ruling and believes it does not align with the law and facts presented at trial. A formal written judgment is expected soon, which will help the company assess its next steps. Navidea focuses on developing precision immunodiagnostic agents and immunotherapeutics.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has completed its rights offering, securing approximately $6.2 million. An additional $11.6 million may be raised through exercised warrants with a price of $0.50 per share. The offering led to 4,250 units sold, with specific purchase limits implemented for board vice chairman John K. Scott. The company plans a conference call on September 8, 2022, to discuss Q2 financial results and clinical developments.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) announced preliminary results of its rights offering, which closed on August 24, 2022. The company anticipates total subscriptions of approximately $14.2 million, with gross cash proceeds estimated at $6.1 million, not including up to $15.8 million from warrant exercises. The rights offering involves the exchange and cancellation of outstanding preferred shares worth $8.05 million. Closing is expected on or about August 29, 2022.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) has extended its initial rights offering subscription period to 5:00 PM Eastern time on August 24, 2022. Each subscription right allows the purchase of one unit at $1,000, which includes one share of newly created Series I Convertible Preferred Stock convertible into common stock at $0.45 per share and a warrant for 2,222 shares of common stock with an exercise price of $0.50 per share. Maxim Group LLC is the dealer-manager for the offering.
Navidea Biopharmaceuticals (NAVB) reported Q2 2022 financial results with net revenues of $57,000, down from $261,000 in Q2 2021. The net loss attributable to common stockholders widened to $3.0 million, or $0.10 per share, compared to a loss of $2.7 million, or $0.09 per share, in the same quarter last year. Ongoing Phase 3 trial enrollment for rheumatoid arthritis continues, alongside positive preliminary results from the NAV3-32 Phase 2b trial. The company closed a $2.5 million bridge loan and received $800,000 from a strategic partner for R&D expenses.
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