NAVB Navidea Biopharmaceuticals Inc.

2.33
-0.11  -5%
Previous Close 2.44
Open 2.38
52 Week Low 0.63
52 Week High 5.3569
Market Cap $65,204,279
Shares 27,984,669
Float 19,838,944
Enterprise Value $49,762,958
Volume 129,520
Av. Daily Volume 364,094
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Drug Pipeline

Drug Stage Notes
NAV3-32 (TC99m-tilmanocept)
Rheumatoid arthritis
Phase 2b
Phase 2b
Phase 2b commencement of US site enrollment announced February 8, 2021. Phase 3 trial planned.
Lymphoseek
Head and Neck Cancer
Approved
Approved
Approved June 13, 2014.
NAV4694
Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)
Phase 3
Phase 3
Phase 3 - seeking partner to continue development
Lymphoseek
Lymphatic-tissue tracing agent
Approved
Approved
Approved March 13, 2013.

Latest News

  1. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announces that management will present a company overview and hold virtual meetings with investors at the H.C. Wainwright Global Life Sciences Virtual Conference being held March 9-10, 2021.

    The Navidea presentation can be accessed by registering for the H.C. Wainwright Global Life Sciences Virtual Conference here. The webcast will be available on the H.C. Wainwright Conference Portal beginning March 9, 2021 at 7:00 a.m. Eastern time through March 10, 2021 at 9:00 p.m. Eastern time. The Company's corporate presentation can be accessed from the Investor Relations section…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announces that management will present a company overview and hold virtual meetings with investors at the H.C. Wainwright Global Life Sciences Virtual Conference being held March 9-10, 2021.

    The Navidea presentation can be accessed by registering for the H.C. Wainwright Global Life Sciences Virtual Conference here. The webcast will be available on the H.C. Wainwright Conference Portal beginning March 9, 2021 at 7:00 a.m. Eastern time through March 10, 2021 at 9:00 p.m. Eastern time. The Company's corporate presentation can be accessed from the Investor Relations section of the Company website here.

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea's strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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  2. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that it has executed an agreement with the Company's largest shareholder, John K. Scott, Jr., to purchase $5 million of newly-designated Series E Redeemable Convertible Preferred Stock. Over the next 18 months, the Series E Preferred can be converted into approximately 2.17 million shares of Navidea's common stock.

    "We are pleased to receive continued support from our largest shareholder. Today's financing provides additional strength to our balance sheet and will allow our company to accelerate potential value-accretive investments, including our…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that it has executed an agreement with the Company's largest shareholder, John K. Scott, Jr., to purchase $5 million of newly-designated Series E Redeemable Convertible Preferred Stock. Over the next 18 months, the Series E Preferred can be converted into approximately 2.17 million shares of Navidea's common stock.

    "We are pleased to receive continued support from our largest shareholder. Today's financing provides additional strength to our balance sheet and will allow our company to accelerate potential value-accretive investments, including our therapeutics pipeline," commented Jed Latkin, Chief Executive Officer of Navidea. "We look forward to providing additional updates on the progress of our ongoing studies across our portfolio on our earnings call later this month."

    John K. Scott, Jr. commented, "I am pleased to be given the opportunity to continue to support Navidea as it moves some of its key assets into the next phase of development. As a stockholder in Navidea since December 2003, I believe in the Company's drug candidates and the positive contributions they can make to individuals and the scientific community."

    The securities offered and to be sold by Navidea in the private placement to Mr. Scott have not been registered under the Securities Act of 1933 (the "Securities Act"), as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (the "SEC") or an applicable exemption from registration requirements. Navidea has agreed to file a registration statement with the SEC covering the resale of the shares of common stock to be issued to Mr. Scott.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Navidea's securities. No offer, solicitation or sale will be made in any state or other jurisdiction in which such offering, solicitation or sale would be unlawful.

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea's strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: market and other conditions, our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

    Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

    You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report, except as required by law. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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  3. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that the Company has submitted its formal Type B Meeting Request to the FDA. The FDA has granted the Type B meeting and has requested submission of the Briefing Book. The FDA will now review the Company's formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol. Navidea's previous and ongoing clinical studies in Rheumatoid Arthritis ("RA") will also be provided. Navidea expects formal feedback from the FDA within the next several months and a potential launch of the pivotal Phase 3 study…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that the Company has submitted its formal Type B Meeting Request to the FDA. The FDA has granted the Type B meeting and has requested submission of the Briefing Book. The FDA will now review the Company's formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol. Navidea's previous and ongoing clinical studies in Rheumatoid Arthritis ("RA") will also be provided. Navidea expects formal feedback from the FDA within the next several months and a potential launch of the pivotal Phase 3 study in the second quarter of 2021.

    This pivotal Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNFα therapy. The design and planned conduct of the Phase 3 trial is built upon data from Navidea's ongoing NAV3-31 Phase 2B trial that is providing supportive evidence that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active RA and that this imaging can provide an early indicator of treatment response.

    Navidea is also pleased to announce the opening of the first US site for enrollment in its NAV3-32 Phase 2B trial titled, "A Comparison of Tc99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)." This trial will examine the correlation of Tc99m tilmanocept imaging quantification to the macrophage number and density and immune cell composition in joints. This may permit Tc99m tilmanocept imaging to act as a "virtual biopsy," characterizing a patient's individual RA pathological subtype with potential to predict therapeutic responses beyond those of anti-TNFα therapies.

    Michael Rosol, Chief Medical Officer for Navidea, said, "We are eager to receive feedback from the FDA on our NAV3-31 Phase 3 design, and are excited to have opened up our first site in the important NAV3-32 trial. Throughout our RA program development, we have worked closely with expert rheumatologists, nuclear medicine specialists, and the FDA itself, and we believe we are on the right path to bring a valuable tool to bear to meet a large unmet medical need of patients with RA." Dr. Rosol continued, "Success of these trials would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFα treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than would otherwise be possible today."

    Jed Latkin, Navidea's Chief Executive Officer, said, "I am pleased that the FDA responded so quickly to the meeting request and look forward to a constructive dialogue with the FDA over the two months. Furthermore, the launch of NAV3-32 is a momentous step in the Company's drive towards the eventual approval of both the RA monitoring agent and the use of Tilmanocept as a key biomarker for inflammation. While COVID might have slowed the development timeline we remain focused on opening more sites for NAV3-32 as lockdowns in the UK and Europe subside."

    RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population1. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.

    Reference

    1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea's strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. Forward-looking statements include our expectations regarding pending litigation and other matters. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our history of operating losses and uncertainty of future profitability; the final outcome of any pending litigation; our ability to successfully complete research and further development of our drug candidates; the timing, cost and uncertainty of obtaining regulatory approvals of our drug candidates; our ability to successfully commercialize our drug candidates; dependence on royalties and grant revenue; our ability to implement our growth strategy; anticipated trends in our business; our limited product line and distribution channels; advances in technologies and development of new competitive products; our ability to comply with the NYSE American continued listing standards; our ability to maintain effective internal control over financial reporting; the impact of the current coronavirus pandemic; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at http://www.sec.gov or at http://ir.navidea.com.

    Investors are urged to consider statements that include the words "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

    You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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  4. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the company will be presenting at the 2021 ICR Conference on Thursday, January 14, 2021 at 2:30 p.m. Eastern Standard Time.

    The Company will be represented at the conference by Jed Latkin, Chief Executive Officer, and Joel Kaufman, Chief Business Officer. A live video webcast of the presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.navidea.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

    Event: 2021 ICR Conference
    Date…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the company will be presenting at the 2021 ICR Conference on Thursday, January 14, 2021 at 2:30 p.m. Eastern Standard Time.

    The Company will be represented at the conference by Jed Latkin, Chief Executive Officer, and Joel Kaufman, Chief Business Officer. A live video webcast of the presentation will be available on the IR Calendar page of the Investors section of the Company's website (www.navidea.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

    Event: 2021 ICR Conference

    Date: Thursday, January 14, 2021

    Time: 2:30 p.m. EST

    Location: Virtual Conference

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea's strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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  5. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment Malcolm G. Witter to its Board of Directors.

    Mr. Witter brings decades of financial and corporate governance experience to the board. He currently serves as a corporate development leader for USI Insurance Services ("USI") and is responsible for acquiring independent insurance agencies. Prior to USI, Mr. Witter held roles at multiple financial institutions including Bear Stearns, EF Hutton, and Dean Witter. Mr. Witter received his MBA from the Stanford Graduate School of Business and he also serves as the President of the Dean Witter Foundation…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment Malcolm G. Witter to its Board of Directors.

    Mr. Witter brings decades of financial and corporate governance experience to the board. He currently serves as a corporate development leader for USI Insurance Services ("USI") and is responsible for acquiring independent insurance agencies. Prior to USI, Mr. Witter held roles at multiple financial institutions including Bear Stearns, EF Hutton, and Dean Witter. Mr. Witter received his MBA from the Stanford Graduate School of Business and he also serves as the President of the Dean Witter Foundation.

    Jed Latkin, Navidea's CEO said, "We are fortunate to have Malcolm Witter join Navidea's Board of Directors. Malcolm's expertise in M&A, corporate finance, and corporate governance better equip the Company as it moves into the new year. We look forward to Malcolm's input and engagement in guiding Navidea toward future development and success."

    About Navidea

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept™ platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea's strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company's pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

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