NAVB Navidea Biopharmaceuticals Inc.

4.02
-0.05  -1%
Previous Close 4.07
Open 4.15
52 Week Low 0.49
52 Week High 4.446
Market Cap $95,972,616
Shares 23,873,785
Float 18,148,663
Enterprise Value $97,522,590
Volume 282,284
Av. Daily Volume 2,241,869
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Upcoming Catalysts

Drug Stage Catalyst Date
NAV3-31 (TC99m-tilmanocept)
Rheumatoid arthritis
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
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. DUBLIN, OH, June 15, 2020 (GLOBE NEWSWIRE) -- 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 full enrollment in its ongoing NAV3-31 Phase 2B study titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging". All of the subjects have been enrolled in the three-arm trial, and the study is on track for the last patient to be screened, and evaluated by end of 2020. 

    The aim of this Phase 2B study is to evaluate the repeatability, reproducibility, and stability of Tc99m tilmanocept imaging in both healthy subjects (Arm 1) and in patients…

    DUBLIN, OH, June 15, 2020 (GLOBE NEWSWIRE) -- 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 full enrollment in its ongoing NAV3-31 Phase 2B study titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging". All of the subjects have been enrolled in the three-arm trial, and the study is on track for the last patient to be screened, and evaluated by end of 2020. 

    The aim of this Phase 2B study is to evaluate the repeatability, reproducibility, and stability of Tc99m tilmanocept imaging in both healthy subjects (Arm 1) and in patients with active RA (Arm 2), as well as to assess the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") alpha treatment in RA patients (Arm 3). The third arm mirrors Navidea's Phase 3 study, which has been designed to provide data to understand the magnitude of the signal change that could potentially occur as patients receive therapy. Navidea has enrolled 38 subjects in each Arm (1 and 2), and has concluded with another 29 subjects in Arm 3. Subjects in Arm 3 will be followed up to a period of 24 weeks with regular imaging of Tc99m tilmanocept and clinical assessments at predetermined intervals from time of initiation of anti-TNF alpha. 

    Interim results previously announced in this trial have provided supportive evidence for Navidea's hypotheses that Tc99m tilmanocept imaging can potentially provide a robust, quantifiable imaging assessment of RA-involved joints that enable the early prediction for physicians to confirm the appropriate clinical response. Navidea remains on track to meet with the FDA to finalize the Phase 3 study design, and the Phase 2B trial will continue in parallel until completion. 

    Michael Rosol, Chief Medical Officer for Navidea, said, "We are pleased that we were able to fully enroll the required patients in this trial and are on schedule through the current situation with COVID-19. I give full credit to everyone involved in this study for their accomplishments. The enrollment to date gives us encouragement that we will be able to hit the ground running with our planned Phase 3 study later this year." Dr. Rosol continued, "As I have said before, we are excited that we are on track to potentially provide rheumatologists and those suffering with RA with 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, "I am encouraged by the positive feedback we have been given by the physicians and collaborators involved in this transformational Phase 2B trial. We look forward to leveraging the momentum we have generated with NAV3-31 toward our planned NAV3-33 Phase 3 trial later this year."

    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 our current studies and potential results, FDA approval process, ability to provide rheumatologists and those suffering from RA with expected benefits, the accuracy and timing of our imaging as an indication of treatment effectiveness, the use of our imaging as part of treatment for RA patients, our ability to progress into a Phase 3 study, our ability to successfully develop products, and the role of Navidea in the management of RA worldwide. 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. 

    Contact



    Navidea Biopharmaceuticals, Inc.

    Jed Latkin, CEO

    614-973-7490

    PCG Advisory, Inc.

    Adam Holdsworth

    646-862-4607

    Primary Logo

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  2.  Live Video Moderated Discussion with CEO, Jed Latkin, to be Held on Tuesday, June 16th, at 2:00 PM ET, Immediately Followed by an Interactive Q&A Session

    DUBLIN, Ohio, June 09, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Jed Latkin, Navidea's Chief Executive Officer, will present at the Virtual Investor Fireside Chat Series on Tuesday, June 16, 2020 at 2:00 PM ET.

    A live video webcast of the fireside chat will be available on the IR Calendar page of the Investors section of the Company's website (www.navidea.com). Immediately following the…

     Live Video Moderated Discussion with CEO, Jed Latkin, to be Held on Tuesday, June 16th, at 2:00 PM ET, Immediately Followed by an Interactive Q&A Session

    DUBLIN, Ohio, June 09, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Jed Latkin, Navidea's Chief Executive Officer, will present at the Virtual Investor Fireside Chat Series on Tuesday, June 16, 2020 at 2:00 PM ET.

    A live video webcast of the fireside chat will be available on the IR Calendar page of the Investors section of the Company's website (www.navidea.com). Immediately following the fireside chat, management will participate in an interactive Q&A session with interested parties, allowing participants to type in questions and receive live responses. A webcast replay will be available two hours following the live presentation and will be accessible for one year.

    To schedule a one-on-one call with management, please submit a request through the conference website vifiresidechat.com, or contact the conference at . For more information about the event, please visit vifiresidechat.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 our current studies and potential results, FDA approval process, ability to provide rheumatologists and those suffering from RA with expected benefits, the accuracy and timing of our imaging as an indication of treatment effectiveness, the use of our imaging as part of treatment for RA patients, our ability to progress into a Phase 3 study, our ability to successfully develop products, and the role of Navidea in the management of RA worldwide. 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.

    Contact

    Navidea Biopharmaceuticals, Inc.

    Jed Latkin, CEO

    614-973-7490

    PCG Advisory, Inc.

    Adam Holdsworth

    646-862-4607

    Primary Logo

    View Full Article Hide Full Article
  3. DUBLIN, Ohio, June 03, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that the results from the Company's first interim analysis of its ongoing NAV3-31 phase 2b clinical study will be presented as a poster at the European League Against Rheumatism ("EULAR") Congress 2020. The poster is titled, "A Phase 2b Study of Intravenously Administered Tc 99m Tilmanocept to Determine Differential Uptake, Reproducibility Over Time and Image Stability in Healthy Subjects and in Patients with Rheumatoid Arthritis ("RA") on Stable Treatment." 

    The aim of this interim…

    DUBLIN, Ohio, June 03, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that the results from the Company's first interim analysis of its ongoing NAV3-31 phase 2b clinical study will be presented as a poster at the European League Against Rheumatism ("EULAR") Congress 2020. The poster is titled, "A Phase 2b Study of Intravenously Administered Tc 99m Tilmanocept to Determine Differential Uptake, Reproducibility Over Time and Image Stability in Healthy Subjects and in Patients with Rheumatoid Arthritis ("RA") on Stable Treatment." 

    The aim of this interim analysis of the phase 2b study was to evaluate reproducibility and stability of imaging and to assess quantitative Tc99m tilmanocept uptake cut points that can reliably enable discrimination between joints of healthy people and RA patients. Results were supportive of the hypothesis that Tc99m tilmanocept imaging can provide robust, quantifiable imaging in healthy control ("HC") and RA subjects. No disease-related localization in the hands and wrists were observed in HC subjects. Localization in RA subjects was observed at levels consistent with macrophage densities observed in other studies evaluating RA synovial biopsies. Active RA images exhibit the same localization patterns on test-retest images taken on the same day as well as in subjects with images acquired on one day and again 8 days later. Results show low imaging readout variability with root mean squared differences that are approximately 10% or less of the observed localization of Tc99m tilmanocept, enabling reliable quantification of joints with RA-involved macrophage-mediated inflammation. Analysis of the HC and RA images was used to determine initial quantitative "cut-points" to differentiate between joints with and without the inflammation typically seen in RA.

    The EULAR Scientific Committee informed all participants that this year's face-to-face annual congress slated to be held in Frankfurt, Germany, June 3-6, 2020 will now be conducted as a virtual congress experience. The eCongress will be available online under the abstract number THU0540 on the EULAR 2020 website. The poster abstract will also be published in the "Annals of Rheumatic Diseases."

    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 EULAR congress committee and the opportunity to present our results at this international 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. With these results, along with our more recent interim look results announced on May 21, 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 EULAR continues that record of success."

    Note that this news was under embargo by EULAR until 12:01 am CET June 3, 2020.

    RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population.1 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 our current studies and potential results, FDA approval process, ability to provide rheumatologists and those suffering from RA with expected benefits, the accuracy and timing of our imaging as an indication of treatment effectiveness, the use of our imaging as part of treatment for RA patients, our ability to progress into a Phase 3 study, our ability to successfully develop products, and the role of Navidea in the management of RA worldwide. 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.

    Contact

    Navidea Biopharmaceuticals, Inc.
    Jed Latkin, CEO
    614-973-7490

    PCG Advisory, Inc.
    Adam Holdsworth
    646-862-4607

    Primary Logo

    View Full Article Hide Full Article
    • Access the event and schedule of presenting companies at www.vifiresidechat.com
    • Live video webcast fireside chat presentations and interactive Q&A with participants
    • Presentations at 10:00 AM, 12:00 PM and 2:00 PM ET on June 15, 16 and 17, 2020

    FRENCHTOWN, NJ / ACCESSWIRE / June 2, 2020 / JTC Team ("JTC"), a fully integrated corporate communications firm, today announced they will host the first of its Virtual Investor Fireside Chat Series on June 15th , 16th and 17th, 2020 with company presentations at 10:00 AM ET, 12:00 PM ET and 2:00 PM ET each day. The Virtual Investor Fireside Chat Series will feature public companies from a variety of industries including biotechnology, nutraceuticals/medical foods, infrastructure and consumer products…

    • Access the event and schedule of presenting companies at www.vifiresidechat.com
    • Live video webcast fireside chat presentations and interactive Q&A with participants
    • Presentations at 10:00 AM, 12:00 PM and 2:00 PM ET on June 15, 16 and 17, 2020

    FRENCHTOWN, NJ / ACCESSWIRE / June 2, 2020 / JTC Team ("JTC"), a fully integrated corporate communications firm, today announced they will host the first of its Virtual Investor Fireside Chat Series on June 15th , 16th and 17th, 2020 with company presentations at 10:00 AM ET, 12:00 PM ET and 2:00 PM ET each day. The Virtual Investor Fireside Chat Series will feature public companies from a variety of industries including biotechnology, nutraceuticals/medical foods, infrastructure and consumer products. As part of the virtual video event, JTC will host a moderated, in-depth discussion with each participating company's Chief Executive Officer, followed by an interactive Q&A session that will allow participants to ask questions.

    Investors and interested parties can access the event schedule and individual company webcast details at www.vifiresidechat.com. In addition to the fireside chat presentations, each management team will be available for 1x1 virtual meetings from qualified members of the investment community which can be requested through the event website or by emailing a request to .

    "The COVID-19 pandemic has affected how we all conduct business, and with health safety guidelines and travel restrictions continuing, the need for innovative solutions for companies to engage with the investment community has never been greater," commented Jenene Thomas, CEO and Founder of JTC Team. "With that in mind, we are pleased to offer a strategic format with our Virtual Investor platform and our Fireside Chat Series that enables participating companies the ability to stay active with investors, while providing the ability to outline key areas of importance and to discuss what they believe is the true value proposition and investment opportunity."

    The presenting company schedule for the first Virtual Investor Fireside Chat Series is:

    Monday, June 15, 2020

    Tuesday, June 16, 2020

    Wednesday, June 17, 2020

    For more information about the event, please visit the conference website at www.vifiresidechat.com or contact .


    About JTC Team, LLC

    JTC is a fully integrated corporate communications firm that is dedicated to helping you tell your story to the right audiences in order to build awareness and achieve your goals. JTC was founded over 8 years ago and has developed a reputation of excellence for executing on robust communication strategies that deliver results. The Company's client roster over the years has included both public and private companies across the Life Sciences and Technology industries to help them establish and execute their corporate communications, raise awareness and build shareholder value. For more information, please visit www.jtcir.comor connect with the company on Twitter and LinkedIn.

    Contact:

    Jenene Thomas
    JTC Team, LLC
    T: +1 (833) 475-8247

    SOURCE: JTC Team, LLC

    View source version on accesswire.com:
    https://www.accesswire.com/592445/JTC-Team-to-Host-Virtual-Investor-Fireside-Chat-Series-with-CEOs-from-Companies-Across-Multiple-Industries-on-June-15th-16th-and-17th

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  4. Conference Call to be held Thursday, May 21, 2020 at 5:30 pm EDT

    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 preliminary results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2B study. Analysis demonstrates that these interim data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis ("RA"), and that this imaging can provide…

    Conference Call to be held Thursday, May 21, 2020 at 5:30 pm EDT

    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 preliminary results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2B study. Analysis demonstrates that these interim data further corroborate Navidea's hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis ("RA"), and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.

    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 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 which 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 weeks on 8 of the 15 subjects. The remaining 7 subjects had received baseline and 5-week scans only 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 demonstrate:

    • Tc99m tilmanocept imaging from baseline to week 5 was predictive of clinical outcome at 12 weeks in 7 out of 8 subjects with 12-week clinical assessment available at the time of the interim analysis. The one subject who did not demonstrate concordance of signal quantification and clinical assessment had undergone a change in treatment regime while enrolled in the trial that may have impacted the trajectory of the clinical response.
    • 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.
    • In the subjects with 12-week follow up data available, global Tc99m tilmanocept signals declined by an average of 58% from baseline to week 5 in those who responded significantly to anti-TNF alpha treatment by week 12. In those subjects who did not have a significant clinical response to anti-TNF alpha treatment by week 12, Tc99m tilmanocept signals increased by an average of 79% from baseline to 5 weeks. These preliminary results indicate that marked changes in Tc99m tilmanocept global uptake values by week 5 are in agreement with clinical efficacy evaluations made at week 12 of treatment.
    • 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 interim 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.

    Michael Rosol, Chief Medical Officer for Navidea, said, "We are encouraged by these interim results, which are in line with our hypotheses, support the continuation of the current Phase 2B study, and will be fundamental to speaking with the FDA about moving forward into the Phase 3 trial later this year." 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, "I am once again very pleased that the interim results of our ongoing Phase 2B study are so encouraging. These data support our belief that Tc99m tilmanocept imaging has the potential to provide an early and accurate indication of treatment effectiveness to rheumatologists, allowing them to tailor effective treatment regimens for RA patients. We are looking forward to continuing our progress into a Phase 3 study."

    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.

    Conference Call Details

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

    Event:

    Results of Interim Analysis of Phase 2B Study in Rheumatoid Arthritis

    Date:

    Thursday, May 21, 2020

    Time:

    5:30 p.m. (EDT)

    U.S. & Canada Dial-in:

    877-407-0312

    International Dial-in:

     

    +1-201-389-0899

    Conference ID:

    13704352

    Webcast Link:

     

    https://78449.themediaframe.com/dataconf/productusers/navidea/mediaframe/38396/indexl.html

    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 our current studies and potential results, FDA approval process, ability to provide rheumatologists and those suffering from RA with expected benefits, the accuracy and timing of our imaging as an indication of treatment effectiveness, the use of our imaging as part of treatment for RA patients, our ability to progress into a Phase 3 study, our ability to successfully develop products, and the role of Navidea in the management of RA worldwide. 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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