NAVB Navidea Biopharmaceuticals Inc.

1.58
+0.02  (+1%)
Previous Close 1.56
Open 1.6
52 Week Low 1.46
52 Week High 3.15
Market Cap $47,757,466
Shares 30,163,245
Float 19,704,436
Enterprise Value $39,470,034
Volume 11,557
Av. Daily Volume 67,480
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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. End of Phase 2b (NAV3-31 trial) meeting with FDA scheduled for September 1, 2021. Phase 3 trial planned.
LYMPHOSEEK (technetium Tc 99m tilmanocept)
Lymphatic-tissue tracing agent
Approved
Approved
Approved March 13, 2013.
LYMPHOSEEK (technetium Tc 99m tilmanocept)
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

Latest News

  1. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on September 14, 2021, at a meeting of the Board of Directors (the "Board") of the Company that followed the Company's 2021 Annual Meeting of Stockholders, S. Kathryn Rouan, Ph.D. retired as Chair of the Board and as a director, and Claudine Bruck, Ph.D. retired as a director, both effective immediately.

    Following the retirement of Dr. Rouan as Chair, the Board appointed Alexander L. Cappello and John K. Scott, Jr., who were both existing members of the Board, as Chair of the Board and Vice Chair of the Board, respectively.

    Also effective September…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on September 14, 2021, at a meeting of the Board of Directors (the "Board") of the Company that followed the Company's 2021 Annual Meeting of Stockholders, S. Kathryn Rouan, Ph.D. retired as Chair of the Board and as a director, and Claudine Bruck, Ph.D. retired as a director, both effective immediately.

    Following the retirement of Dr. Rouan as Chair, the Board appointed Alexander L. Cappello and John K. Scott, Jr., who were both existing members of the Board, as Chair of the Board and Vice Chair of the Board, respectively.

    Also effective September 14, 2021, the Board appointed Mr. Cappello to the Audit Committee, and therefore the current members of the Audit Committee are Amit Bhalla (Chair), Malcolm Witter and Mr. Cappello. On the same date, the Board appointed Messrs. Cappello and Scott to the Compensation, Nominating and Governance ("CNG") Committee and appointed Mr. Witter as Chair, and therefore, the current members of the CNG Committee are Mr. Witter (Chair), Mr. Scott and Mr. Cappello.

    Jed Latkin, Navidea's CEO said, "We thank both Kathy and Claudine for their service on the Board and the valuable insights they have provided over the years. With a combined 60 years of experience in the clinical space their contributions helped shape both the diagnostic and therapeutic direction of the Company. We wish them the best in their future endeavors."

    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 Wednesday, August 11, 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 second quarter and year-to-date for the period ended June 30, 2021.

    "The Company is prepared and looking forward to our meeting with the U.S. Food and Drug Administration ("FDA") on September 1," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We remain laser focused on a positive meeting and a successful launch to the NAV3-33 trial. Navidea is also extremely excited to now have a full 7-member board with the appointments of Amit Bhalla, Alex…

    Conference Call to be held Wednesday, August 11, 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 second quarter and year-to-date for the period ended June 30, 2021.

    "The Company is prepared and looking forward to our meeting with the U.S. Food and Drug Administration ("FDA") on September 1," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We remain laser focused on a positive meeting and a successful launch to the NAV3-33 trial. Navidea is also extremely excited to now have a full 7-member board with the appointments of Amit Bhalla, Alex Cappello and John K. Scott, Jr. to the board."

    Second Quarter 2021 Highlights and Subsequent Events

    • Scheduled an End-of-Phase 2 Type B meeting with the FDA to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.
    • Achieved study closeout in the Company's NAV3-31 Phase 2b study.
    • Opened the first U.S. site, Northwestern University, as well as the primary U.K. site, Queen Mary University of London, for enrollment in the Company's NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. A second U.S. site, Attune Health Research, will be opened on August 13, 2021.
    • Enrolled over 115 subjects in the Company's NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Expected total enrollment for this two-arm trial will be 135 participants.
    • Completed 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.
    • Announced the granting of a National Institutes of Health ("NIH") award to the University of California San Diego School of Medicine for the proposal entitled, "Renal Molecular Imaging of Mesangial Cell Function with Tc-99m-Tilmanocept." The award (Project Number: 1R01DK127201-01), from the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH, was granted to Co-Principal Investigators UC San Diego faculty Carl Hoh, MD and David Vera, PhD, of the Department of Radiology, and Charles Ginsberg, MD, MAS, of the Department of Medicine, Division of Nephrology.
    • Results from the Company's preclinical studies of its targeted cancer immunotherapeutic agent were 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."
    • Announced that the U.S. Patent and Trademark Office ("USPTO") issued to Navidea U.S. patent 11,007,272, entitled "Compounds and Methods for Diagnosis and Treatment of Viral Infections," with protection to October 7, 2037.
    • Converted the provisional patent application "Synthesis of Uniformly Defined Molecular Weight Mannosylated Dextrans and Derivatives Thereof" to an A1 application on July 9, 2021.
    • Appointed Amit Bhalla to the Company's Board of Directors. Mr. Bhalla brings a wealth of financial experience and over 20 years of pharmaceutical experience to the board.
    • Appointed John K. Scott, Jr. and Alex Cappello to the Board of Directors. Mr. Scott is the Company's largest shareholder and Mr. Cappello brings over 30 years of banking and public board experience to the Company.
    • Announced that on June 23, 2021, Vice Chancellor Joseph Slights of the Court of Chancery of the State of Delaware (the "Court") ruled in favor of Navidea's wholly-owned subsidiary, Macrophage Therapeutics, Inc. ("MT") and against its former CEO, Dr. Michael Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT. In addition, the Court denied Dr. Goldberg's motion to hold MT's directors and CEO in contempt, denied Dr. Goldberg's motion to dismiss the lawsuit against him, and granted MT's motion to dismiss Dr. Goldberg's petition to remove MT's board members.

    Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. We are preparing for our September discussion with the FDA over the results of the completed NAV3-31 Phase 2b trial as well as our proposed plan for the Phase 3 study. We continue to prepare for initiation of the Phase 3 and have opened up key sites for enrollment into the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we continue to make exciting progress in our therapeutics pipeline, and we expect to continue to advance these towards the clinic."

    Financial Results

    • Total net revenues for the second quarter of 2021 were $261,000, compared to $271,000 for the same period in 2020. Total net revenues for the first six months of 2021 were $385,000, compared to $427,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept™ development, offset by receipt of reimbursement from Cardinal Health 414, LLC of certain research and development ("R&D") costs and the partial recovery of debts previously written off in 2015.
    • R&D expenses for the second quarter of 2021 were $1.5 million, compared to $1.3 million in the same period in 2020. R&D expenses for the first six months of 2021 were $2.7 million, compared to $2.3 million in the same period in 2020. The increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic and therapeutic development costs. The net increase in research and development expenses also included increased regulatory consulting expenses offset by decreased employee compensation including incentive-based awards.
    • Selling, general and administrative ("SG&A") expenses for the second quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020. SG&A expenses for the first six months of 2021 were $3.7 million, compared to $3.2 million in the same period in 2020. The net increase was primarily due increased consulting services related to preparing for European distribution of Tc99m tilmanocept, increased employee compensation including incentive-based awards, increased insurance cost, increased director fees related to additional board members, increased general office expenses, increased travel costs and increased European license fees, offset by decreased legal and professional services and decreased investor relations costs.
    • Navidea's net loss attributable to common stockholders for the second quarter of 2021 was $2.7 million, or $0.09 per share, compared to $2.4 million, or $0.11 per share, for the same period in 2020. Navidea's net loss attributable to common stockholders for the first six months of 2021 was $5.6 million, or $0.20 per share, compared to $5.1 million, or $0.24 per share, for the same period in 2020.
    • Navidea ended the second quarter of 2021 with $7.1 million in cash and cash equivalents.

    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: Second Quarter 2021 Earnings Conference Call and Business Update

    Date: Wednesday, August 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: 13721827

    Webcast Link: https://webcast-eqs.com/navidbioph20210811/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  
      June 30, December 31,
     

    2021

    2020

      (unaudited)
    Assets:  
    Cash and cash equivalents  

    $

    7,114,103

     

    $

    2,670,495

     

    Other current assets  

     

    2,929,307

     

     

    3,857,833

     

    Non-current assets  

     

    1,237,900

     

     

    1,229,690

     

    Total assets  

    $

    11,281,310

     

    $

    7,758,018

     

       
    Liabilities and stockholders' equity:  
    Current liabilities  

    $

    4,024,669

     

    $

    4,715,105

     

    Deferred revenue, non-current  

     

    700,000

     

     

    700,000

     

    Other liabilities  

     

    120,471

     

     

    296,006

     

    Total liabilities  

     

    4,845,140

     

     

    5,711,111

     

    Navidea stockholders' equity  

     

    5,704,870

     

     

    1,315,604

     

    Noncontrolling interest  

     

    731,300

     

     

    731,303

     

    Total stockholders' equity  

     

    6,436,170

     

     

    2,046,907

     

    Total liabilities and stockholders' equity  

    $

    11,281,310

     

    $

    7,758,018

     

       
       
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS    
       
      Three Months Ended Six Months Ended
      June 30, June 30, June 30, June 30,
     

    2021

    2020

    2021

    2020

      (unaudited) (unaudited) (unaudited) (unaudited)
       
    Revenue  

    $

    261,046

     

    $

    271,101

     

    $

    384,783

     

    $

    427,373

     

    Cost of revenue  

     

    -

     

     

    357

     

     

    -

     

     

    966

     

    Gross profit  

     

    261,046

     

     

    270,744

     

     

    384,783

     

     

    426,407

     

    Operating expenses:  
    Research and development  

     

    1,498,056

     

     

    1,281,779

     

     

    2,720,810

     

     

    2,281,048

     

    Selling, general and administrative  

     

    1,432,610

     

     

    1,329,591

     

     

    3,663,355

     

     

    3,157,345

     

    Total operating expenses  

     

    2,930,666

     

     

    2,611,370

     

     

    6,384,165

     

     

    5,438,393

     

    Loss from operations  

     

    (2,669,620

    )

     

    (2,340,626

    )

     

    (5,999,382

    )

     

    (5,011,986

    )

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

     

    1,266

     

     

    15,343

     

     

    (1,609

    )

     

    12,971

     

    Gain on extinguishment of debt  

     

    -

     

     

    -

     

     

    366,000

     

     

    -

     

    Other, net  

     

    (5,686

    )

     

    (336

    )

     

    (5,941

    )

     

    (212

    )

    Net loss  

     

    (2,674,040

    )

     

    (2,325,619

    )

     

    (5,640,932

    )

     

    (4,999,227

    )

    Loss (income) attributable to noncontrolling interest  

     

    1

     

     

    1

     

     

    3

     

     

    (1

    )

    Deemed dividend on Series C Preferred Stock beneficial conversion feature  

     

    -

     

     

    (77,778

    )

     

    -

     

     

    (77,778

    )

    Net loss attributable to common stockholders  

    $

    (2,674,039

    )

    $

    (2,403,396

    )

    $

    (5,640,929

    )

    $

    (5,077,006

    )

       
    Loss attributable to common stockholders per common share (basic and diluted)  

    $

    (0.09

    )

    $

    (0.11

    )

    $

    (0.20

    )

    $

    (0.24

    )

    Weighted average shares outstanding (basic and diluted)  

     

    29,117,832

     

     

    22,759,393

     

     

    28,531,660

     

     

    21,481,514

     

     

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  3. Conference Call to be Held on Wednesday, August 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 Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be…

    Conference Call to be Held on Wednesday, August 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 Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, 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: Second Quarter 2021 Earnings Conference Call and Business Update

    Date: Wednesday, August 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: 13721827

    Webcast Link: https://webcast-eqs.com/navidbioph20210811/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.

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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 over 110 subjects have been enrolled and imaged in its NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Expected total enrollment for this two-arm trial will be 135 participants.

    NAV3-35 will establish a database of hand and wrist images taken following Tc99m tilmanocept administration in healthy volunteers age- and sex-matched to the population of RA patients. Tc99m tilmanocept attaches to mannose receptors (CD206) on macrophages that are frequently involved in RA joint inflammation…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that over 110 subjects have been enrolled and imaged in its NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Expected total enrollment for this two-arm trial will be 135 participants.

    NAV3-35 will establish a database of hand and wrist images taken following Tc99m tilmanocept administration in healthy volunteers age- and sex-matched to the population of RA patients. Tc99m tilmanocept attaches to mannose receptors (CD206) on macrophages that are frequently involved in RA joint inflammation. Relatively smaller numbers of CD206 expressing macrophages normally reside in the joints of healthy people without RA. An integral part of the ability to quantitatively discriminate RA-inflamed joints from those that do not have inflammation using Tc99m tilmanocept imaging is the knowledge of the distribution of Tc99m tilmanocept localization in healthy joints. The establishment of this normal subject database (i.e., normative database) will enable improved accuracy of discrimination of RA-involved joints from non-RA inflamed joints and should have a positive impact on the ability to predict treatment response early. This database will also be used in the training of automated image analysis algorithms to further improve the accuracy of the quantification of Tc99m tilmanocept localization in joints as well as the workflow for later commercialization in RA.

    The aim is to recruit 135 volunteers in this two-arm study. The first arm is comprised of 120 healthy subjects who will have planar imaging of their hands and wrists post administration of Tc99m tilmanocept, and arm two is a 15-subject arm comprised of 10 patients with RA and 5 healthy volunteers with the aim of demonstrating the feasibility of 3-dimensional SPECT/CT imaging for the quantitative assessment of RA-involved inflammation in joints. To date, over 100 subjects have been imaged for Arm 1, and 10 in Arm 2.

    Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "The normative database, establishing the parameters of what a normal joint looks like with Tc99m tilmanocept, will play an essential part in both the Phase 3 data analysis as well as planned commercial product." Dr. Rosol continued, "These data will also be used to optimize automated image analysis to improve upon accuracy and streamline workflow for widespread adoption of Tc99m tilmanocept imaging in RA."

    Jed Latkin, Chief Executive Officer and Chief Financial Officer for Navidea, said, "The rapid enrollment of this trial is truly a testament to Navidea's focus on delivering quick results as we launch more trials to bring the Company ever closer to the launching of the RA Diagnostic product."

    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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  5. 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 U.S. Food and Drug Administration ("FDA") has granted the Company's request for an End-of-Phase 2 Type B meeting to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.

    The meeting with the FDA will be centered on discussion of the results from the Company's completed Phase 2b NAV3-31 study, "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" and the proposed protocol…

    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 U.S. Food and Drug Administration ("FDA") has granted the Company's request for an End-of-Phase 2 Type B meeting to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.

    The meeting with the FDA will be centered on discussion of the results from the Company's completed Phase 2b NAV3-31 study, "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" and the proposed protocol and analysis plans for the Phase 3 trial. Previously, the FDA reviewed the interim data and provided pertinent feedback on progressing the remaining patient data and encouraged an End-of-Phase 2 meeting when complete.

    Navidea's NAV3-31 trial had three arms: Arm 1 consisted of healthy subjects, Arm 2 was comprised of patients with active, moderate-to-severe RA who are on stable therapy, and Arm 3 was a pilot arm designed to assess the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") α treatment in RA patients. Previously reported interim analyses demonstrated results in support of Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.

    The 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 insights and data from the completed Phase 2b NAV3-31 trial.

    Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are eager to discuss the results from our completed Phase 2b trial as well as the design of the planned Phase 3 trial with the FDA. 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 bringing a valuable tool to bear to meet a large unmet medical need in patients with RA." Dr. Rosol continued, "Success 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 is possible today."

    Jed Latkin, Chief Executive Officer and Chief Financial Officer for Navidea, said, "We are very excited to meet with the FDA and finally proceed with launching the Phase 3 trial for the approval of Navidea's RA monitoring agent. The clinical and regulatory teams have been working non-stop to complete the review of a massive amount of data obtained from NAV3-31. I am extremely proud of the work they have accomplished to date and eagerly anticipate the next steps towards approval."

    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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