NAVB Navidea Biopharmaceuticals Inc.

2.28
-0.02  -1%
Previous Close 2.3
Open 2.26
52 Week Low 0.63
52 Week High 5.3569
Market Cap $60,846,811
Shares 26,687,198
Float 18,541,473
Enterprise Value $45,340,617
Volume 88,758
Av. Daily Volume 257,437
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Drug Pipeline

Drug Stage Notes
NAV3-31 (TC99m-tilmanocept)
Rheumatoid arthritis
Phase 2b
Phase 2b
Phase 2b updated data released November 12, 2020.
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. Conference Call to be held Thursday, November 12, 2020 at 5:00 pm EST

    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 third quarter and year-to-date for the period ended September 30, 2020.

    "Navidea continues to build on its clinical momentum and this quarter fully shows our ability to execute during a very trying time globally," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The due diligence continues with Jubilant and the Phase 2b is nearing its conclusion. We are very excited to move forward and present to the FDA in the near future."

    Third Quarter 2020

    Conference Call to be held Thursday, November 12, 2020 at 5:00 pm EST

    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 third quarter and year-to-date for the period ended September 30, 2020.

    "Navidea continues to build on its clinical momentum and this quarter fully shows our ability to execute during a very trying time globally," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The due diligence continues with Jubilant and the Phase 2b is nearing its conclusion. We are very excited to move forward and present to the FDA in the near future."

    Third Quarter 2020 Highlights and Subsequent Events

    • Executed a binding memorandum of understanding ("MOU") on August 9, 2020 with Jubilant Draximage Inc. dba Jubilant Radiopharma, Radiopharmaceuticals Division ("Jubilant"). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement for Navidea's Rheumatoid Arthritis Diagnostic in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.
    • Entered into a Stock Purchase Agreement with investors, pursuant to which the investors agreed to purchase up to $25.0 million in shares of the Company's Common Stock.
    • Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company agreed to issue to the investor 150,000 shares of newly-designated Series D Redeemable Convertible Preferred Stock (the "Series D Preferred Stock") for an aggregate purchase price of $15.0 million. Pursuant to the Series D Preferred Stock Purchase Agreement, Keystone will purchase Series D Preferred Stock in amounts to be determined by Keystone in one or more closings during the nine-month period following the date on which the prospectus supplement to register the underlying Common Stock was filed with the SEC, provided that all of the Series D Preferred Stock must be purchased by such date. The Series D Preferred Stock will be convertible into a maximum of 5,147,000 shares of Common Stock.
    • Announced acceptance by the American College of Rheumatology ("ACR") of the results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting ("ACR Convergence 2020") under the title, "Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy."
    • Continued longitudinal imaging and clinical assessments of Arm 3 subjects, who are beginning new anti-TNFα therapy, in the NAV3-31 trial.
    • 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.
    • Converted a provisional patent on blocking off-target organ uptake of Tilmanocept to improve on-target localization.
    • Received a one-year extension on its NIH phase 1 Small Business Technology Transfer grant (1R41HL147640-01A1) entitled Gallium 68 Tilmanocept for PET Imaging of Atherosclerosis Plaques, due to COVID-19 related shutdown of the research facility at the University of Alabama Birmingham. The site has reopened and these preclinical studies are ongoing.
    • Won dismissal of Platinum-Montaur Life Sciences LLC's lawsuit against the Company.

    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. The currently running Phase 2b trial in RA is proceeding well, with Arm 3 subjects having their later imaging and clinical assessments. Preparation of the package to discuss with the FDA in planning for the upcoming Phase 3 is nearing completion. We are also preparing for the start of our second Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients."

    Financial Results

    • Total revenues for the third quarter 2020 were $268,000, compared to $237,000 for the same period in 2019. Total revenues for the first nine months of 2020 were $696,000, compared to $539,000 for the same period in 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.
    • Research and development ("R&D") expenses for the third quarter of 2020 were $1.4 million, compared to $1.8 million in the same period in 2019. The third quarter decrease was primarily due to net decreases in drug project expenses, including decreased Manocept diagnostic and Tc99m tilmanocept development costs, coupled with decreased employee compensation. R&D expenses for the first nine months of 2020 were $3.7 million, compared to $3.6 million in the same period in 2019. The year-to-date increase was primarily due to net increases in drug project expenses, including increased Manocept diagnostic development costs offset by decreased Manocept therapeutic and Tc99m tilmanocept development costs, coupled with increased employee compensation.
    • Selling, general and administrative ("SG&A") expenses for the third quarter of 2020 were $1.8 million, compared to $1.5 million in the same period in 2019. The third quarter increase was primarily due to increased legal and professional services and employee compensation, offset by decreased travel, insurance, and depreciation costs. SG&A expenses for the first nine months of 2020 were $4.9 million, compared to $5.1 million in the same period in 2019. The year-to-date decrease was primarily due to decreased travel, legal and professional services, insurance, depreciation, and investor relations costs, offset by increased employee compensation and franchise taxes.
    • Navidea's net loss attributable to common stockholders for the third quarter of 2020 was $3.3 million, or $0.13 per share, compared to $3.1 million, or $0.17 per share, for the same period in 2019. Navidea's net loss attributable to common stockholders for the first nine months of 2020 was $8.4 million, or $0.37 per share, compared to $8.2 million, or $0.62 per share, for the same period in 2019.
    • Navidea ended the third quarter of 2020 with $3.7 million in cash and cash equivalents. Since September 30, 2020, the Company has received $700,000 of cash related to the August 2020 funding transactions.

    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:

    Q3 2020 Earnings and Business Update Conference Call

    Date:

    Thursday, November 12, 2020

    Time:

    5:00 p.m. (EST)

    U.S. & Canada Dial-in:

    800-754-1336

    International Dial-in:

     

    +1 415-226-5358

    Conference ID:

    21971993

    Webcast Link:

     

    https://webcasts.eqs.com/navidbioph20201112/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
    September 30, December 31,

    2020

    2019

    (unaudited)
    Assets:
    Cash and cash equivalents

    $

    3,722,852

    $

    1,047,159

     

    Other current assets

     

    1,070,099

     

    1,868,624

     

    Non-current assets

     

    1,202,884

     

    1,235,123

     

    Total assets

    $

    5,995,835

    $

    4,150,906

     

     
    Liabilities and stockholders' equity (deficit):
    Current liabilities

    $

    4,014,418

    $

    3,819,551

     

    Deferred revenue, non-current

     

    700,000

     

    700,000

     

    Other liabilities

     

    380,236

     

    512,344

     

    Total liabilities

     

    5,094,654

     

    5,031,895

     

    Navidea stockholders' equity (deficit)

     

    169,877

     

    (1,612,292

    )

    Noncontrolling interest

     

    731,304

     

    731,303

     

    Total stockholders' equity (deficit)

     

    901,181

     

    (880,989

    )

    Total liabilities and stockholders' equity (deficit)

    $

    5,995,835

    $

    4,150,906

     

     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
     
    Three Months Ended Nine Months Ended
    September 30, September 30, September 30, September 30,

    2020

    2019

    2020

    2019

    (unaudited) (unaudited) (unaudited) (unaudited)
    Revenue:
    Royalty revenue

    $

    2,047

     

    $

    4,895

     

    $

    26,188

     

    $

    13,985

     

    License revenue

     

    4,726

     

     

    -

     

     

    4,726

     

     

    9,953

     

    Grant and other revenue

     

    261,616

     

     

    231,916

     

     

    664,848

     

     

    514,589

     

    Total revenue

     

    268,389

     

     

    236,811

     

     

    695,762

     

     

    538,527

     

    Cost of revenue

     

    82

     

     

    195

     

     

    1,048

     

     

    6,559

     

    Gross profit

     

    268,307

     

     

    236,616

     

     

    694,714

     

     

    531,968

     

    Operating expenses:
    Research and development

     

    1,377,998

     

     

    1,801,558

     

     

    3,659,046

     

     

    3,612,783

     

    Selling, general and administrative

     

    1,788,934

     

     

    1,519,496

     

     

    4,946,279

     

     

    5,109,612

     

    Total operating expenses

     

    3,166,932

     

     

    3,321,054

     

     

    8,605,325

     

     

    8,722,395

     

    Loss from operations

     

    (2,898,625

    )

     

    (3,084,438

    )

     

    (7,910,611

    )

     

    (8,190,427

    )

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

     

    (149

    )

     

    11,858

     

     

    12,822

     

     

    23,336

     

    Other, net

     

    (564

    )

     

    (1,524

    )

     

    (777

    )

     

    (5,880

    )

    Loss before income taxes

     

    (2,899,338

    )

     

    (3,074,104

    )

     

    (7,898,566

    )

     

    (8,172,971

    )

    Provision for income taxes

     

    -

     

     

    -

     

     

    -

     

     

    (707

    )

    Loss from continuing operations

     

    (2,899,338

    )

     

    (3,074,104

    )

     

    (7,898,566

    )

     

    (8,173,678

    )

    Loss from discontinued operations, net of tax effect

     

    -

     

     

    -

     

     

    -

     

     

    (2,665

    )

    Net loss

     

    (2,899,338

    )

     

    (3,074,104

    )

     

    (7,898,566

    )

     

    (8,176,343

    )

    Loss (income) attributable to noncontrolling interest

     

    -

     

     

    2

     

     

    (1

    )

     

    16

     

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

     

    (405,555

    )

     

    -

     

     

    (483,333

    )

     

    -

     

    Net loss attributable to common stockholders

    $

    (3,304,893

    )

    $

    (3,074,102

    )

    $

    (8,381,900

    )

    $

    (8,176,327

    )

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

    $

    (0.13

    )

    $

    (0.17

    )

    $

    (0.37

    )

    $

    (0.62

    )

    Attributable to common stockholders

    $

    (0.13

    )

    $

    (0.17

    )

    $

    (0.37

    )

    $

    (0.62

    )

    Weighted average shares outstanding (basic)

     

    25,843,732

     

     

    18,044,406

     

     

    22,946,201

     

     

    13,082,393

     

     

     

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  2. Data Support Hypothesis that Tc99m Tilmanocept Imaging Can Provide Early Indicator of Treatment Response

    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 positive results from analysis of subjects who have completed Arm 3 of the Company's ongoing NAV3-31 Phase 2B study. These data further corroborate 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.

    Navidea's NAV3-31 Phase 2B trial titled "Evaluation of the Precision and Sensitivity…

    Data Support Hypothesis that Tc99m Tilmanocept Imaging Can Provide Early Indicator of Treatment Response

    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 positive results from analysis of subjects who have completed Arm 3 of the Company's ongoing NAV3-31 Phase 2B study. These data further corroborate 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.

    Navidea's NAV3-31 Phase 2B trial titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" has three arms: Arm 1 consists of healthy subjects, Arm 2 is comprised of patients with active, moderate-to-severe RA who are on stable therapy, and Arm 3 is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") alpha treatment in RA patients.

    This third arm was designed in order to evaluate the magnitude of change of Tc99m tilmanocept signal localized to RA-involved joints in patients before and after treatment with an anti-TNF alpha therapy as well as to examine whether the localization or change in localization can serve as an early, quantifiable predictor of treatment efficacy as determined by clinical assessments at 12 and 24 weeks.

    A total of 16 subjects with active moderate-to-severe RA were included in this analysis, each of whom was set to begin a new or first-time treatment regimen with an anti-TNF alpha therapy. Whole body and hand/wrist planar gamma camera images were obtained at baseline prior to initiation of new treatment, again at 5 weeks post therapy initiation, and then again at 12 and 24 weeks. A panel of established clinical assessments was performed at each time point as well. Results of the preliminary analysis demonstrate:

    • Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 24 weeks in 13 out of 16 patients (81.3%).
    • In this dataset, change from baseline to week 5 in Tc99m tilmanocept imaging had high positive and negative predictive value (PPV and NPV, respectively) for clinical outcome at both 12 and 24 weeks: week 12- PPV= 100%, NPV= 83% and week 24- PPV= 100%, NPV= 77%. These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 are in good agreement with clinical efficacy evaluations made at weeks 12 and 24 of treatment.
    • Early results also support the hypothesis that, in a subset of RA patients, the baseline scan alone can be a reliable predictor of non-responsiveness to anti-TNF alpha therapy.

    These data continue to support Navidea's hypothesis that Tc99m tilmanocept imaging can provide quantifiable imaging assessment of RA-involved joints that enables early prediction of clinical response.

    Michael Rosol, Chief Medical Officer for Navidea, said, "The ongoing analysis of our Phase 2B trial now includes patients followed for up to six months after beginning anti-TNF alpha therapy, and provides us with more evidence that we can objectively predict treatment response early and with a high level of accuracy." Dr. Rosol continued, "We are excited that we are on track to possibly providing rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNF alpha 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, "The data shared today once again demonstrate the power of Tilmanocept to aid in rheumatology treatment decisions and ultimately improve the course of care for the millions of people across the globe suffering from RA." Mr. Latkin continued, "We are encouraged that data from patients who have completed Arm 3 has continued to support our hypothesis, particularly as the study design of Arm 3 will mirror our upcoming pivotal Phase 3 RA trial."

    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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  3. Conference Call to be Held on Thursday, November 12, 2020 at 5:00 p.m. (EST)

    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 Thursday, November 12, 2020 at 5:00 p.m. (EST) to discuss financial results and corporate developments for the third quarter ended September 30, 2020.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Senior Director 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…

    Conference Call to be Held on Thursday, November 12, 2020 at 5:00 p.m. (EST)

    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 Thursday, November 12, 2020 at 5:00 p.m. (EST) to discuss financial results and corporate developments for the third quarter ended September 30, 2020.

    Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Senior Director 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: Q3 2020 Earnings and Business Update Conference Call

    Date: Thursday, November 12, 2020

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

    U.S. & Canada Dial-in: 800-754-1336

    International Dial-in: +1 415-226-5358

    Conference ID: 21971993

    Webcast Link: https://webcasts.eqs.com/navidbioph20201112/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. Live moderated video webcast discussion between members of management and Key Opinion Leader, Jonathan Graf, MD. on Wednesday, October 28th at 4:00 PM ET

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that members of management will participate in the Virtual Investor KOL Roundtable on Wednesday, October 28, 2020 at 4:00 PM ET.

    Participating in the KOL Roundtable discussion will be Jed Latkin, Navidea's Chief Executive Officer and Michael Rosol, Ph.D., Chief Medical Officer of Navidea. Joining the Navidea management team for the discussion will be Jonathan Graf, MD. Dr. Graf is Professor in the Department…

    Live moderated video webcast discussion between members of management and Key Opinion Leader, Jonathan Graf, MD. on Wednesday, October 28th at 4:00 PM ET

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that members of management will participate in the Virtual Investor KOL Roundtable on Wednesday, October 28, 2020 at 4:00 PM ET.

    Participating in the KOL Roundtable discussion will be Jed Latkin, Navidea's Chief Executive Officer and Michael Rosol, Ph.D., Chief Medical Officer of Navidea. Joining the Navidea management team for the discussion will be Jonathan Graf, MD. Dr. Graf is Professor in the Department of Medicine at the University of California San Francisco (UCSF) in the division of rheumatology at Zuckerberg San Francisco General. He is board certified in rheumatology, receiving his MD degree from the University of Pennsylvania and completing his residency and fellowship training at the UCSF School of Medicine. He has been a practicing rheumatologist for nearly 20 years and co-founded the UCSF rheumatoid arthritis (RA) cohort in 2006. He is co-author on numerous publications in the field of rheumatology and has been an investigator on multiple clinical trials related to rheumatoid arthritis. He currently receives research support from Navidea as one of the lead investigators for the NAV3-31 trial in RA, and he has been involved in the design and execution of this and other clinical trials of Tilmanocept in RA.

    A live video webcast of the KOL Roundtable 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.

    In addition to the KOL roundtable discussion, members of the management team will be available for one-on-one meetings with qualified members of the investment community. To schedule a one-on-one call with management, please submit a request through the conference website virtualinvestorco.com, or contact the conference at . For more information about the event, please visit virtualinvestorco.com.

    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.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Navidea is not responsible for the contents of third-party websites.

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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 American College of Rheumatology ("ACR") has accepted the results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting ("ACR Convergence 2020") under the title, "Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy."

    This year's annual meeting will be conducted as a virtual conference from November 5-9, 2020. Navidea's abstract is accessible online at acrabstracts.org, abstract number 1544…

    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 American College of Rheumatology ("ACR") has accepted the results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2b clinical study for presentation at the ACR Annual Meeting ("ACR Convergence 2020") under the title, "Tc99m Tilmanocept Imaging Is an Early Predictor of Clinical Response in Rheumatoid Arthritis Patients Beginning New Anti-TNFα Therapy."

    This year's annual meeting will be conducted as a virtual conference from November 5-9, 2020. Navidea's abstract is accessible online at acrabstracts.org, abstract number 1544, with presentation of the poster on Monday, November 9, 2020 from 9:00 am – 11:00 am Eastern. The poster abstract will also be published in an online supplement of the journal Arthritis & Rheumatology.

    Navidea's NAV3-31 Phase 2b trial titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" has three arms: Arm 1 consists of healthy subjects, Arm 2 is comprised of patients with active, moderate-to-severe rheumatoid arthritis ("RA") who are on stable therapy, and Arm 3 is a pilot arm of the upcoming Phase 3 trial assessing the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") alpha treatment in RA patients.

    This second interim analysis was designed to examine data from Arm 3 of the study in order to evaluate the magnitude of change of Tc99m tilmanocept signal localized to RA-involved joints in patients before and after treatment with an anti-TNF alpha therapy as well as to examine whether this change in localization, if any, can serve as an early, quantifiable predictor of treatment efficacy.

    A total of 15 subjects with active moderate-to-severe RA were included in this interim analysis, each of whom were set to begin a new or first-time treatment regimen with an anti-TNF alpha therapy. Whole body and hand/wrist planar gamma camera images were obtained at baseline prior to initiation of new treatment, again at 5 weeks post therapy initiation, and then again at 12 weeks on 11 of the 15 subjects at the time of this analysis. A panel of established clinical assessments was performed at each time point as well, in order to compare imaging results with clinical standards over the 12-week time course. Results of the preliminary analysis demonstrated:

    • Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 9 out of 11 subjects with 12-week clinical assessment available at the time of the interim analysis.
    • Combined data from all 15 subjects in Arm 3 suggest a wide dynamic range of more than one order of magnitude (>10-fold) for calculated global Tc99m tilmanocept uptake values in joints with RA-involved inflammation.
    • The wide dynamic range of global Tc99m tilmanocept signal readout combined with the low variability of imaging signal quantification established in Arms 1 and 2 of this trial are supportive of the idea that clinically meaningful changes in signal localization can be detected.
    • These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 presage clinical efficacy evaluations at week 12 of treatment.

    These data are supportive of Navidea's hypotheses that Tc99m tilmanocept imaging can provide quantifiable imaging assessment of RA-involved joints that enables early prediction of clinical response as well as longitudinal monitoring of clinical status.

    Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the recognition of the importance of our Phase 2b interim results by the ACR Convergence 2020 scientific committee and the opportunity to present our results at this internationally recognized meeting." Dr. Rosol continued, "This is the type of external validation of our work that reflects the great medical need for a robust, objective, noninvasive means of assessing inflammation in RA-involved joints. It is our expectation that Tc99m tilmanocept can address this need and provide critical information for rheumatologists to put their patients on the correct therapeutic pathway earlier than is currently possible."

    Jed Latkin, Navidea's Chief Executive Officer, said, "It's a great honor that our clinical trial results in RA have been regularly accepted for presentation at international meetings the last several years, and this acceptance by ACR continues that record of success."

    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.

    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.

    References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Navidea is not responsible for the contents of third-party websites.

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