NAVB Navidea Biopharmaceuticals Inc.

1.62
-0.01  -1%
Previous Close 1.63
Open 1.63
52 Week Low 0.86
52 Week High 5.3569
Market Cap $46,279,023
Shares 28,567,298
Float 20,289,636
Enterprise Value $36,644,770
Volume 173,291
Av. Daily Volume 229,864
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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. Industry veteran Amit Bhalla appointed to the Board of Directors

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Michael Rice, the Company's Chair of the Board, and Adam Cutler have retired from their positions on Navidea's Board of Directors to focus on other endeavors. Dr. Kathy Rouan has been appointed as Chair of the Board following Mr. Rice's retirement.

    Additionally, Amit Bhalla has been appointed to Navidea's Board of Directors. Mr. Bhalla currently serves as the Chief Financial Officer of Infinity BiologiX. Prior to his current role he served as a Senior Healthcare Analyst at Lord, Abbett…

    Industry veteran Amit Bhalla appointed to the Board of Directors

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Michael Rice, the Company's Chair of the Board, and Adam Cutler have retired from their positions on Navidea's Board of Directors to focus on other endeavors. Dr. Kathy Rouan has been appointed as Chair of the Board following Mr. Rice's retirement.

    Additionally, Amit Bhalla has been appointed to Navidea's Board of Directors. Mr. Bhalla currently serves as the Chief Financial Officer of Infinity BiologiX. Prior to his current role he served as a Senior Healthcare Analyst at Lord, Abbett & Co. LLC and has held senior leadership positions at multiple Financial and Healthcare firms including Beckton Dickinson, Johnson & Johnson, Citigroup, and Morgan Stanley. Mr. Bhalla received his MBA from the Tepper School of Business and his undergraduate degree at Cornell University.

    Jed Latkin, Navidea's CEO said, "We thank both Michael and Adam for their service on the Board and the valuable insights they have provided over the years. We are excited about the addition of Amit Bhalla to the Board. His diverse background in financial services and operational roles at world class healthcare corporations will provide unique perspectives."

    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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  2. Conference Call to be Held on Tuesday, May 11, 2021 at 5:00 p.m. (EDT)

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Tuesday, May 11 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the first quarter ended March 31, 2021.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions…

    Conference Call to be Held on Tuesday, May 11, 2021 at 5:00 p.m. (EDT)

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Tuesday, May 11 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the first quarter ended March 31, 2021.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

    To participate in the call and webcast, please refer to the information below:

    Event: Q1 2021 Earnings and Business Update Conference Call

    Date: Tuesday, May 11, 2021

    Time: 5:00 p.m. (EDT)

    U.S. & Canada Dial-in: 877-407-0312

    International Dial-in: +1 201-389-0899

    Conference ID: 13718969

    Webcast Link: https://www.webcast-eqs.com/navidbioph20210511/en

    A live audio webcast of the conference call will also be available on the investor relations page of Navidea's corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea's website.

    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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  3. 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 results from the Company's preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science's (NYAS) Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."

    In these studies, Navidea's CD206-targeted therapeutic construct containing doxorubicin linked to its mannosylated dextran backbone (Man-Dox…

    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 results from the Company's preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science's (NYAS) Frontiers in Cancer Immunotherapy Symposium 2021. The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."

    In these studies, Navidea's CD206-targeted therapeutic construct containing doxorubicin linked to its mannosylated dextran backbone (Man-Dox) demonstrated the ability to drive phenotypic change in immune cells towards an activated pro-inflammatory and cell-killing state in vitro and, in conjunction with an approved immunotherapeutic, demonstrated a synergistic effect on tumor growth inhibition in a relevant animal model. The cellular target of Navidea's Man-Dox agent is the macrophage mannose receptor, CD206. CD206 is expressed on TAMs that play a critical role in regulating the tumor microenvironment and which provide a target for immunotherapies to rally the body's own immune system in the fight against cancer.

    In in vitro studies, treatment of human macrophages with Man-Dox drove macrophages from an immunosuppressive phenotype to an immune stimulatory, pro-inflammatory state. In mouse experiments using the syngeneic CT26 tumor model, Man-Dox, in combination with anti-CTLA4 therapy, showed a significant reduction in tumor growth compared to treatments with either agent alone or with free doxorubicin. Anti-CTLA4 improves anti-tumor immune responses by blocking a check point inhibitor that prevents stimulation of adaptive immune cells by pro-inflammatory macrophages. These new findings support Navidea's hypothesis that driving the TAM phenotype towards a pro-inflammatory state with Man-Dox in concert with an approved immunotherapy provides a synergistic effect on tumor cell killing. These results demonstrate that Navidea's targeted Man-Dox construct can improve the efficacy of an existing immunotherapy and support further studies to help define optimal dosing strategies to maximize this synergistic effect.

    This year's conference will be virtual and will take place from May 12th through May 14th. Navidea's presentation will provide a more detailed look at analysis of these data.

    Information regarding registration for the symposium can be found on the NYAS website (link here).

    Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the recognition of the importance of our preclinical results by the symposium committee and the opportunity to present our results at this internationally recognized meeting." Dr. Rosol continued, "This important work demonstrates both a mechanism of action as well as efficacy in relevant in vitro and in vivo model systems. These positive results help lay the foundation for moving forward into an FDA IND application followed by first in human studies."

    Jed Latkin, Navidea's Chief Executive Officer, said, "This is truly a tribute to the many hours of hard work spent by our dedicated team to hone in on a compound that shows remarkable design, enabling this and future pre-clinical clinical work."

    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. Conference Call to be held Wednesday, March 24, 2021 at 5:00 pm EDT

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and full year for the period ended December 31, 2020.

    "We are very excited about the progress we have made, completing all the patients in the Phase 2B NAV3-31 trial and submitting our briefing book to the FDA were milestone accomplishments this past year," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are looking forward to hearing back from the FDA and continuing our due diligence discussions with Jubilant over the near term…

    Conference Call to be held Wednesday, March 24, 2021 at 5:00 pm EDT

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and full year for the period ended December 31, 2020.

    "We are very excited about the progress we have made, completing all the patients in the Phase 2B NAV3-31 trial and submitting our briefing book to the FDA were milestone accomplishments this past year," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are looking forward to hearing back from the FDA and continuing our due diligence discussions with Jubilant over the near term."

    Fourth Quarter 2020 Highlights and Subsequent Events

    • Announced positive results from continued analysis of subjects who have completed Arm 3 of the Company's NAV3-31 Phase 2B study. These data further corroborated Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active rheumatoid arthritis ("RA") and that this imaging can provide an early indicator of treatment efficacy.
    • Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration ("FDA"). The FDA granted the Type B meeting and the Company has submitted the Briefing Book. The FDA is currently reviewing these formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol.
    • Achieved last patient, last visit in the Company's NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
    • Opened the first US site, Northwestern University, for enrollment in the Company's NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA.
    • Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
    • Received notice of patent grant from the USPTO for US 10,806,803: "Compositions for targeting macrophages and other CD206 high expressing cells and methods of treating and diagnosis."
    • Received a notice of allowance from the USPTO for the patent application: "Compounds and methods for diagnosis and treatment of viral infections" (US Patent Application 15/729,635).
    • Performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state and a synergistic effect on tumor growth reduction using the Company's doxorubicin-containing construct with an approved checkpoint inhibitor therapy.
    • Appointed Malcolm G. Witter to the Company's Board of Directors. Mr. Witter brings decades of financial and corporate governance experience to the board.
    • Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the "Series E Preferred Stock") for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.

    Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have completed all patients and all visits in our NAV3-31 Phase 2B trial and we are eagerly anticipating feedback from the FDA on our briefing package and design of the Phase 3 trial. We continue to prepare for initiation of this trial and have also opened up enrollment for the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we have made exciting progress in our therapeutics pipeline and will continue to advance these towards the clinic."

    Financial Results

    • Total net revenues for the fourth quarter 2020 were $219,000, compared to $119,000 for the same period in 2019. Total net revenues for the full year of 2020 were $914,000, compared to $651,000 for 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept™ development coupled with increased license revenue from net transitional sales in Europe.
    • Research and development ("R&D") expenses for the fourth quarter of 2020 were $1.3 million, compared to $1.7 million in the same period in 2019. R&D expenses for the full year of 2020 were $4.9 million, compared to $5.3 million in the same period in 2019. The decreases were primarily due to net decreases in drug project expenses, including decreased Manocept therapeutic development costs, decreased Manocept diagnostic development costs, and decreased Tc99m development costs, offset by increased NAV4694 development costs. The net decreases also included decreased regulatory consulting and travel expenses offset by increased employee compensation.
    • Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2020 were $1.7 million, compared to $1.2 million in the same period in 2019. SG&A expenses for the full year of 2020 were $6.7 million, compared to $6.3 million in 2019. The net increases were primarily due to increased legal and professional services, employee compensation, European Medicines Agency annual fees for Lymphoseek, and franchise taxes, offset by decreased travel, depreciation and amortization, losses on disposal of assets, insurance, and investor relations services.
    • Navidea's net loss attributable to common stockholders for the fourth quarter of 2020 was $3.0 million, or $0.11 per share, compared to $2.8 million, or $0.15 per share, for the same period in 2019. Navidea's net loss attributable to common stockholders for the full year of 2020 was $11.4 million, or $0.48 per share, compared to $10.9 million, or $0.76 per share, for 2019.
    • Navidea ended the fourth quarter of 2020 with $2.7 million in cash and cash equivalents. Since December 31, 2020, the Company has received $7.9 million of cash related to the Series D and Series E Preferred Stock funding transactions. To date, the Company has received over $14 million of proceeds from the issuance of Series C, Series D and Series E Preferred stock.

    Conference Call Details

    Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

    Event:

    Q4 2020 Earnings and Business Update Conference Call

    Date:

    Wednesday, March 24, 2021

    Time:

    5:00 p.m. (EDT)

    U.S. & Canada Dial-in:

    877-407-0312

    International Dial-in:

     

    +1 201-389-0899

    Conference ID:

    13714810

    Webcast Link:

     

    https://webcasts.eqs.com/navidbioph20210324/en

    A live audio webcast of the conference call will also be available on the investor relations page of Navidea's corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea's website.

    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.

    NAVIDEA BIOPHARMACEUTICALS, INC.
     
    CONDENSED CONSOLIDATED BALANCE SHEETS
    December 31, December 31,

    2020

     2019

    (unaudited)
    Assets:
    Cash and cash equivalents

    $

    2,670,495

     

    $

    1,047,159

     

    Other current assets

     

    3,857,833

     

     

    1,868,624

     

    Non-current assets

     

    1,229,690

     

     

    1,235,123

    Total assets

    $

    7,758,018

     

    $

    4,150,906

     

     
    Liabilities and stockholders' equity (deficit):
    Current liabilities

    $

    4,715,105

     

    $

    3,819,551

     

    Deferred revenue, non-current

     

    700,000

     

     

    700,000

     

    Other liabilities

     

    296,006

     

     

    512,344

     

    Total liabilities

     

    5,711,111

     

     

    5,031,895

     

    Navidea stockholders' equity (deficit)

     

    1,315,604

     

     

    (1,612,292

    )

    Noncontrolling interest

     

    731,303

     

     

    731,303

     

    Total stockholders' equity (deficit)

     

    2,046,907

     

     

    (880,989

    )

    Total liabilities and stockholders' equity (deficit)

    $

    7,758,018

     

    $

    4,150,906

     

     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
     
    Three Months Ended Twelve Months Ended
    December 31, December 31, December 31, December 31,

    2020

    2019

    2020

     2019

    (unaudited) (unaudited) (unaudited)
     
    Revenue

    $

    219,251

     

    $

    119,299

     

    $

    915,013

     

    $

    657,826

     

    Cost of revenue

     

    -

     

     

    108

     

     

    1,048

     

     

    6,667

     

    Gross profit

     

    219,251

     

     

    119,191

     

     

    913,965

     

     

    651,159

     

    Operating expenses:
    Research and development

     

    1,271,141

     

     

    1,725,484

     

     

    4,930,187

     

     

    5,338,267

     

    Selling, general and administrative

     

    1,748,680

     

     

    1,165,797

     

     

    6,694,959

     

     

    6,275,409

     

    Total operating expenses

     

    3,019,821

     

     

    2,891,281

     

     

    11,625,146

     

     

    11,613,676

     

    Loss from operations

     

    (2,800,570

    )

     

    (2,772,090

    )

     

    (10,711,181

    )

     

    (10,962,517

    )

    Other income (expense):
    Interest income (expense), net

     

    (1,478

    )

     

    1,952

     

     

    11,344

     

     

    25,288

     

    Other, net

     

    (21,078

    )

     

    (1,733

    )

     

    (21,855

    )

     

    (7,613

    )

    Loss before income taxes

     

    (2,823,126

    )

     

    (2,771,871

    )

     

    (10,721,692

    )

     

    (10,944,842

    )

    Benefit from (provision for) income taxes

     

    -

     

     

    -

     

     

    -

     

     

    (707

    )

    Loss from continuing operations

     

    (2,823,126

    )

     

    (2,771,871

    )

     

    (10,721,692

    )

     

    (10,945,549

    )

    Loss from discontinued operations, net of tax effect

     

    -

     

     

    -

     

     

    -

     

     

    (2,665

    )

    Net loss

     

    (2,823,126

    )

     

    (2,771,871

    )

     

    (10,721,692

    )

     

    (10,948,214

    )

    Loss (income) attributable to noncontrolling interest

     

    1

     

     

    (33

    )

     

    -

     

     

    (17

    )

    Deemed dividend on Series C and Series D
    preferred stock beneficial conversion feature

     

    (180,556

    )

     

    -

     

     

    (663,889

    )

     

    -

     

    Net loss attributable to common stockholders

    $

    (3,003,681

    )

    $

    (2,771,904

    )

    $

    (11,385,581

    )

    $

    (10,948,231

    )

    Loss per common share (basic and diluted):
    Continuing operations

    $

    (0.11

    )

    $

    (0.15

    )

    $

    (0.48

    )

    $

    (0.76

    )

    Attributable to common stockholders

    $

    (0.11

    )

    $

    (0.15

    )

    $

    (0.48

    )

    $

    (0.76

    )

    Weighted average shares outstanding (basic and diluted)

     

    26,724,753

     

     

    18,283,512

     

     

    23,896,001

     

     

    14,393,360

     

     

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  5. Conference Call to be Held on Wednesday, March 24, 2021 at 5:00 p.m. (EDT)

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Wednesday, March 24, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the fourth quarter ended December 31, 2020.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer…

    Conference Call to be Held on Wednesday, March 24, 2021 at 5:00 p.m. (EDT)

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Wednesday, March 24, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the fourth quarter ended December 31, 2020.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

    To participate in the call and webcast, please refer to the information below:

    Event: Q4 2020 Earnings and Business Update Conference Call

    Date: Wednesday, March 24, 2021

    Time: 5:00 p.m. (EDT)

    U.S. & Canada Dial-in: 877-407-0312

    International Dial-in: +1 201-389-0899

    Conference ID: 13714810

    Webcast Link: https://www.webcast-eqs.com/navidbioph20210324/en

    A live audio webcast of the conference call will also be available on the investor relations page of Navidea's corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea's website.

    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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