NAVB Navidea Biopharmaceuticals Inc.

2.94
+0.15  (+5%)
Previous Close 2.79
Open 2.79
52 Week Low 0.6
52 Week High 5.3569
Market Cap $77,373,188
Shares 26,317,411
Float 18,171,686
Enterprise Value $76,878,130
Volume 172,445
Av. Daily Volume 367,055
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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. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Mr. Jed Latkin, Chief Executive Officer, will present at the H.C. Wainwright 22nd Annual Global Investment Conference. The virtual conference will be held on September 14-16, 2020. Mr. Latkin will present on Wednesday, September 16 at 10:30 a.m. EST.

    Details of Navidea's presentation are below. For those who wish to listen to the live webcast, please use the following link: https://wsw.com/webcast/hcw7/navb/1597167. The webcast will be archived on Navidea's investor relations website, https://ir.navidea.com/news-events for 90 days following the live…

    Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Mr. Jed Latkin, Chief Executive Officer, will present at the H.C. Wainwright 22nd Annual Global Investment Conference. The virtual conference will be held on September 14-16, 2020. Mr. Latkin will present on Wednesday, September 16 at 10:30 a.m. EST.

    Details of Navidea's presentation are below. For those who wish to listen to the live webcast, please use the following link: https://wsw.com/webcast/hcw7/navb/1597167. The webcast will be archived on Navidea's investor relations website, https://ir.navidea.com/news-events for 90 days following the live presentation.

    Event: H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Wednesday, September 16, 2020

    Time: 10:30 - 10:50 a.m. EDT

    Location: Virtual Conference

    Presentation Webcast Link: https://wsw.com/webcast/hcw7/navb/1597167

    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 Navidea's ability to enter into the ELDA on terms acceptable to Navidea, if at all, potential benefits to Navidea under the ELDA, Jubilant's ability to act as an effective commercial and distribution partner, and Jubilant's expected expansion into the radio-diagnostics market. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our ability to negotiate and enter into the ELDA on acceptable terms, if at all; Jubilant's ability to act as a successful commercial distribution partner; 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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  2. Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, is pleased to announce that on September 2, 2020 the Supreme Court of the State of New York, New York County (the "Court") has dismissed with prejudice Platinum-Montaur Life Sciences LLC's ("Platinum-Montaur") law suit against the Company.

    In the case, Platinum-Montaur asserted several theories as to why it believed the Company owed it a balance of approximately $1,900,000. The Court rejected Platinum-Montaur's claims and instead found that any interest asserted by Platinum-Montaur was unambiguously assigned away several years ago. As such, the Court ruled that Platinum-Montaur…

    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 on September 2, 2020 the Supreme Court of the State of New York, New York County (the "Court") has dismissed with prejudice Platinum-Montaur Life Sciences LLC's ("Platinum-Montaur") law suit against the Company.

    In the case, Platinum-Montaur asserted several theories as to why it believed the Company owed it a balance of approximately $1,900,000. The Court rejected Platinum-Montaur's claims and instead found that any interest asserted by Platinum-Montaur was unambiguously assigned away several years ago. As such, the Court ruled that Platinum-Montaur had failed to state any claim under which it was entitled to money from Navidea.

    Platinum-Montaur has the right to seek appellate review of the Court's dismissal of its claims. Platinum-Montaur's intent with respect to an appeal has not been determined.

    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 Navidea's ability to enter into the ELDA on terms acceptable to Navidea, if at all, potential benefits to Navidea under the ELDA, Jubilant's ability to act as an effective commercial and distribution partner, and Jubilant's expected expansion into the radio-diagnostics market. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our ability to negotiate and enter into the ELDA on acceptable terms, if at all; Jubilant's ability to act as a successful commercial distribution partner; 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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  3. Conference Call to be held Thursday, August 13, 2020 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, 2020.

    "The past four months have been truly momentous for the company. The successful second interim look showed how valuable our diagnostic agent will be for the effective management of Rheumatoid Arthritis," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The signing of the binding MOU with Jubilant is a transformational event for the future of Navidea. Partnering with the second…

    Conference Call to be held Thursday, August 13, 2020 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, 2020.

    "The past four months have been truly momentous for the company. The successful second interim look showed how valuable our diagnostic agent will be for the effective management of Rheumatoid Arthritis," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The signing of the binding MOU with Jubilant is a transformational event for the future of Navidea. Partnering with the second largest radiopharmaceutical company in the United States and a global leader in pharmaceuticals is something we have worked hard to achieve for many years. Furthermore, the $25 million in growth capital pledged by a top-notch syndicate of investors has assured the company's non-RA related growth funding for years to come."

    Second 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.
    • Signed a binding commitment letter on August 9, 2020 with Mastiff Group LLC, for a private placement financing of up to $25 million in aggregate gross proceeds of shares of Navidea's common stock, to be priced either "at the market" or at a premium to Navidea's closing price on the date of execution. Navidea expects to sign definitive documents for a common stock only transaction, with an investor syndicate comprised of Mastiff Group LLC, John Kim Scott, Jr. and other fundamental biotech focused investors no later than August 18, 2020, with the closing to take place within 15 business days thereafter.
    • Regained the commercialization and distribution rights for Lymphoseek® (Tc99m tilmanocept) injection in Europe through the mutually agreed upon termination of the perpetual license agreement with SpePharm AG, a subsidiary of Norgine B.V.
    • Finalized the previously announced $4.2 million financing related to the judgment by the Ohio Court of Common Pleas (the "Judgment"). Navidea agreed to issue Keystone Capital Partners, LLC, up to $4.2 million of convertible preferred shares, which will be guaranteed by a portion of the proceeds of the Judgment.
    • Announced positive preliminary results from the Company's second interim analysis of its ongoing NAV3-31 Phase 2b study. Analysis demonstrated 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.
    • Achieved 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, with the protocol-specified longitudinal imaging events on track.
    • Presented results from the Company's first interim analysis of its ongoing NAV3-31 phase 2b clinical study, 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, at the European League Against Rheumatism ("EULAR") Congress 2020.
    • 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.
    • Filed a provisional patent on improved synthesis of Tilmanocept.
    • 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.

    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. Our currently running Phase 2b trial in RA is proceeding well and, building upon the interim analysis results, we are preparing to discuss the upcoming Phase 3 with the FDA. 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 second quarter 2020 were $271,000, compared to $260,000 for the same period in 2019. Total revenues for the first half of 2020 were $427,000, compared to $302,000 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 second quarter of 2020 were $1.3 million, compared to $1.1 million in the same period in 2019. R&D expenses for the first half of 2020 were $2.3 million, compared to $1.8 million in the same period in 2019. The increases were primarily due to net increases in drug project expenses, including increased Manocept™ diagnostic development costs offset by decreased Manocept therapeutic development costs, coupled with increased employee compensation.
    • Selling, general and administrative ("SG&A") expenses for the second quarter of 2020 were $1.3 million, compared to $1.9 million in the same period in 2019. SG&A expenses for the first half of 2020 were $3.2 million, compared to $3.6 million in the same period in 2019. The decrease was primarily due to decreased legal and professional services, travel, insurance, depreciation, and investor relations costs, offset by increased employee compensation and franchise taxes.
    • Navidea's net loss attributable to common stockholders for the second quarter of 2020 was $2.4 million, or $0.11 per share, compared to $2.7 million, or $0.24 per share, for the same period in 2019. Navidea's net loss attributable to common stockholders for the first half of 2020 was $5.1 million, or $0.24 per share, compared to $5.1 million, or $0.48 per share, for the same period in 2019.
    • Navidea ended the second quarter of 2020 with $1.6 million in cash and investments. Since June 30, 2020, the Company has received the final $3.9 million of cash related to the February 2020 funding transactions. In addition, the Company received $1.0 million related to execution of the Jubilant MOU in August 2020.

    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:

    Q2 2020 Earnings and Business Update Conference Call

    Date:

    Thursday, August 13, 2020

    Time:

    5:00 p.m. (EDT)

    U.S. & Canada Dial-in:

    877-407-0312

    International Dial-in:

     

    +1 201-389-0899

    Conference ID:

    13708190

    Webcast Link:

     

    https://webcasts.eqs.com/navidbioph20200813/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,
     

    2020

     

    2019

      (unaudited)    
    Assets:    
    Cash and cash equivalents  

     $

       1,617,001

     

     

     $

       1,047,159

     

    Other current assets  

     

          4,449,021

     

     

     

          1,868,624

     

    Non-current assets  

     

          1,040,661

     

     

     

          1,235,123

     

    Total assets  

     $

       7,106,683

     

     

     $

       4,150,906

     

         
    Liabilities, mezzanine equity and stockholders' deficit:    
    Current liabilities  

     $

       4,145,074

     

     

     $

       3,819,551

     

    Lease liabilities, non-current  

     

             434,324

     

     

     

             512,344

     

    Deferred revenue, non-current  

     

             700,000

     

     

     

             700,000

     

    Total liabilities  

     

          5,279,398

     

     

     

          5,031,895

     

    Mezzanine equity  

     

          3,450,000

     

     

     

                        -

     

    Navidea stockholders' deficit  

     

         (2,354,019

    )

     

     

         (1,612,292

    )

    Noncontrolling interest  

     

             731,304

     

     

     

             731,303

     

    Total stockholders' deficit  

     

         (1,622,715

    )

     

     

           (880,989

    )

    Total liabilities, mezzanine equity and stockholders' deficit  

     $

       7,106,683

     

     

     $

       4,150,906

     

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

    2020

     

    2019

     

    2020

     

    2019

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

     $

              8,920

     

     

     $

              5,940

     

     

     $

            24,141

     

     

     $

              9,090

    License revenue  

     

                        -

     

     

     

                9,953

     

     

     

                        -

     

     

     

                9,953

    Grant and other revenue  

     

             262,181

     

     

     

             244,199

     

     

     

             403,232

     

     

     

             282,673

    Total revenue  

     

             271,101

     

     

     

             260,092

     

     

     

             427,373

     

     

     

             301,716

     

    Cost of revenue  

     

                   357

     

     

     

                   238

     

     

     

                   966

     

     

     

                6,364

     

    Gross profit  

     

             270,744

     

     

     

             259,854

     

     

     

             426,407

     

     

     

             295,352

     

    Operating expenses:        
    Research and development  

     

          1,281,779

     

     

     

          1,070,642

     

     

     

          2,281,048

     

     

     

          1,811,225

    Selling, general and administrative  

     

          1,329,591

     

     

     

          1,861,600

     

     

     

          3,157,345

     

     

     

          3,590,116

    Total operating expenses  

     

          2,611,370

     

     

     

          2,932,242

     

     

     

          5,438,393

     

     

     

          5,401,341

     

    Loss from operations  

     

         (2,340,626

    )

     

     

         (2,672,388

    )

     

     

         (5,011,986

    )

     

     

         (5,105,989

    )

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

     

               15,343

     

     

     

                1,630

     

     

     

               12,971

     

     

     

               11,478

    Other, net  

     

                  (336

    )

     

     

               (3,220

    )

     

     

                  (212

    )

     

     

               (4,356

    )

    Loss before income taxes  

     

         (2,325,619

    )

     

     

         (2,673,978

    )

     

     

         (4,999,227

    )

     

     

         (5,098,867

    )

    Benefit from (provision for) income taxes  

     

                        -

     

     

     

                   168

     

     

     

                        -

     

     

     

                  (708

    )

    Loss from continuing operations  

     

         (2,325,619

    )

     

     

         (2,673,810

    )

     

     

         (4,999,227

    )

     

     

         (5,099,575

    )

    Income (loss) from discontinued operations, net of tax effect  

     

                        -

     

     

     

                   632

     

     

     

                        -

     

     

     

               (2,665

    )

    Net loss  

     

         (2,325,619

    )

     

     

         (2,673,178

    )

     

     

         (4,999,227

    )

     

     

         (5,102,240

    )

    Less loss attributable to noncontrolling interest  

     

                      (1

    )

     

     

                      (3

    )

     

     

                       1

     

     

     

                    (15

    )

    Deemed dividend on Series C Preferred Stock beneficial conversion feature  

     

             (77,778

    )

     

     

                        -

     

     

     

             (77,778

    )

     

     

                        -

     

    Net loss attributable to common stockholders  

     $

      (2,403,396

    )

     

     $

      (2,673,175

    )

     

     $

      (5,077,006

    )

     

     $

      (5,102,225

    )

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

     $

              (0.11

    )

     

     $

              (0.24

    )

     

     $

              (0.24

    )

     

     $

              (0.48

    )

    Attributable to common stockholders  

     $

              (0.11

    )

     

     $

              (0.24

    )

     

     $

              (0.24

    )

     

     $

              (0.48

    )

    Weighted average shares outstanding  

     

        22,759,393

     

     

     

        11,096,834

     

     

     

        21,481,514

     

     

     

        10,560,265

     

     

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  4. Jubilant Radiopharma, a business unit of Jubilant Pharma Limited and Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) announced today that both companies have signed a binding memorandum of understanding ("MOU"). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement ("ELDA") for Navidea's diagnostic imaging agent Tilmanocept (technetium Tc 99m tilmanocept injection) in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant Radiopharma also made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.

    Tilmanocept, which is entering Phase 3 clinical trials for approval by the United States Food and Drug…

    Jubilant Radiopharma, a business unit of Jubilant Pharma Limited and Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) announced today that both companies have signed a binding memorandum of understanding ("MOU"). The MOU outlines the terms and framework for an Exclusive License and Distribution Agreement ("ELDA") for Navidea's diagnostic imaging agent Tilmanocept (technetium Tc 99m tilmanocept injection) in the United States, Canada, Mexico, and Latin America. In connection with the MOU, Jubilant Radiopharma also made a $1 million equity investment in exchange for a limited exclusivity period while final due diligence efforts are completed.

    Tilmanocept, which is entering Phase 3 clinical trials for approval by the United States Food and Drug Administration (FDA), will enable Nuclear Medicine departments to visually and quantifiably localize and monitor activated macrophages in patients suspected of having rheumatoid arthritis (RA). RA is a painful long-term autoimmune disorder that primarily affects joints in the human body resulting in long term damage if left untreated. In the Unites States over 1.3 million Americans suffer from this disease.

    "For many years oncologists, cardiologists, neurologists and many other medical specialties have benefited from the information nuclear medicine procedures provide them to guide the way they manage their patients," commented Sergio Calvo, President Radiopharmaceuticals Division, Jubilant Radiopharma. "We are confident rheumatologists will also benefit from these procedures, creating an even greater demand for this valuable modality."

    "Jubilant Radiopharma business is focused on developing, manufacturing, commercializing and distributing diagnostic and therapeutic radiopharmaceuticals," stated Pramod Yadav, CEO, Jubilant Pharma Limited. "Jubilant Radiopharma is committed to improving lives through Nuclear Medicine by providing healthcare professionals access to high quality, FDA approved products that enable better patient outcomes. We are pleased to partner with Navidea Biopharmaceuticals to create access to this important new diagnostic imaging agent."

    "Correct characterization of this debilitating disease and having the ability to monitor therapeutic response to drug therapies is of significant importance to patients," said Dr. Michael Rosol, Chief Medical Officer at Navidea. "Visualizing disease processes at the cellular level will provide even greater information to health care providers, ensuring the appropriate therapy is administered at the appropriate time yielding better patient outcomes."

    "We're excited about the prospect of this partnership with Jubilant Pharma," said Jed Latkin, CEO of Navidea. "The combination of Jubilant's large nuclear medicine footprint and commitment to expand its penetration in the radio-diagnostics market makes them the ideal partner for our Rheumatoid Arthritis diagnostic. Execution of the ELDA will be a monumental step forward for our company."

    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 about Navidea Biopharmaceuticals please visit www.navidea.com.

    About Jubilant Pharma Limited

    Jubilant Pharma Limited (JPL), a company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Life Sciences Limited, is an integrated global Pharmaceutical company engaged in manufacturing and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile Injectables and Non Sterile products through six USFDA approved manufacturing facilities in the US, Canada and India and a network of over 50 radiopharmacies in the US. The Company has a team of around 5,200 multicultural people across the globe and is committed to deliver value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally.

    For more information about Jubilant Radiopharma please visit www.jubilantradiopharma.com

    Navidea Forward-Looking Statement

    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 Navidea's ability to enter into the ELDA on terms acceptable to Navidea, if at all, potential benefits to Navidea under the ELDA, Jubilant's ability to act as an effective commercial and distribution partner, and Jubilant's expected expansion into the radio- diagnostics market. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our ability to negotiate and enter into the ELDA on acceptable terms, if at all; Jubilant's ability to act as a successful commercial distribution partner; 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. Recently established firm is led by former Millennium Management executive Fredric Zaino.

    Keystone Capital Partners today announced the formation of its investment platform led by hedge fund veteran Fred Zaino. During a successful 15-year career at multi-billion-dollar global investment management firm Millennium, Mr. Zaino successfully identified and invested in hundreds of companies through bottom-up, fundamental analysis with a focus on the Biotech/MedTech sector.

    "Keystone aims to help overlooked and underfunded companies reach their goals by providing a stable and equitable source of capital through creative investment structures," said Mr. Zaino, Chief Investment Officer at Keystone. "I've learned throughout my career that the best…

    Recently established firm is led by former Millennium Management executive Fredric Zaino.

    Keystone Capital Partners today announced the formation of its investment platform led by hedge fund veteran Fred Zaino. During a successful 15-year career at multi-billion-dollar global investment management firm Millennium, Mr. Zaino successfully identified and invested in hundreds of companies through bottom-up, fundamental analysis with a focus on the Biotech/MedTech sector.

    "Keystone aims to help overlooked and underfunded companies reach their goals by providing a stable and equitable source of capital through creative investment structures," said Mr. Zaino, Chief Investment Officer at Keystone. "I've learned throughout my career that the best returns are often generated from the strongest partnerships, and Keystone will invest in building long-term, mutually beneficial relationships with strong management teams to help them meet and exceed their business objectives."

    Structured as a family office, Keystone is unburdened by the restrictions of typical third-party investors and has the ability to deploy capital to its portfolio companies in a flexible, unconstrained and timely manner. The firm is focused on building long-term capital partnerships with attractively valued micro-cap, small-cap, and mid-cap public and private companies. While generally sector-agnostic, industries of focus include biotech, real estate and consumer products.

    The firm's initial investments include:

    • An up to $25 million commitment to purchase common stock in PolarityTE, Inc. (NASDAQ:PTE), a biotechnology company developing regenerative tissue products and biomaterials.
    • An up to $5 million commitment to purchase common stock in Vaccinex, Inc. (NASDAQ:VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in Huntington's disease (HD) and cancer.
    • Investments in Navidea Biopharmaceuticals, Inc., (NYSE:NAVB), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics.
    • Varian Biopharma, Inc., a privately held corporation, is developing a first-in-class atypical Protein Kinase C Iota (aPKCi) inhibitor; an oncogene required for the growth of multiple forms of human cancers including basal cell carcinoma and pancreatic cancer, among others.
    • Stella Diagnostics, LLC, is a privately held, molecular diagnostics-based organization focused on improving patient management strategies for over 67 million people living with severe esophageal disease. StellaDX's proprietary technology offers physicians insight into the molecular properties of their patients' tissue to determine if the disease is stable, progressing or turning cancerous. Their goal is to become a first-line diagnostic tool that provides superior targeted information compared to the current standard of care.

    Keystone's creative financing solutions are unique for each company, always working in cooperation with management teams with the ultimate goal of achieving full value for all stakeholders.

    For more information, visit www.keystone-cp.com

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