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NEWS -- Navidea Biopharmaceuticals Appoints Joshua Wilson to the Board of Directors; Announces Dates Related to its 2022 Annual Meeting of Stockholders
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Joshua (“Josh”) Wilson to its Board of Directors, effective September 30, 2022, with a term ending concurrently with the Company’s 2024 annual stockholders’ meeting.
Mr. Wilson is a seasoned banking and finance executive with more than 23 years of financial services and family office experience. During his career, Mr. Wilson focused his efforts on raising capital and streamlining company operations for profit and non-profit entities, raising more than $500 million. Currently, Mr. Wilson is the Chief Executive Officer for the UpSwing Foundation, focusing on raising capital for the vertical construction of UpSwing Foundation’s World Headquarters and overseeing all day-to-day operations of its business in support of the Foundation’s mission of “Connecting People and Catapulting Dreams-Together,” achieved through access to elite athletic facilities, multi-sport training, and scholarship opportunities. Mr. Wilson is also the Executive Director of G2G Ventures, a Colorado-based single-family office, focusing on the creation of its first four private equity partnership funds with assets in energy, industrial warehousing, biotechnology and biopharmaceuticals. Mr. Wilson has served in both of these positions since June 2022. From 2017 to June 2022, Mr. Wilson was State President-CO/WY-AZ-CA of First Western Trust Bank, and from 2011 to 2016, he served as Chief Financial Officer/Family Office Executive of Central Resources, Inc. Prior to that, Mr. Wilson held roles of increasing responsibility at multiple financial institutions, including Market President-Denver of First Western Trust Bank, Senior Vice President of Vectra Private Bank, and Vice President of Bank One/JP Morgan Chase. Mr. Wilson currently serves on the board of directors of Lynx Energy ULC, with prior board experience with First Western Trust. Mr. Wilson currently serves on the Audit and Finance Committees of National Western Stock Show and The Club at Rolling Hills. Mr. Wilson received his B.S. in Business Administration from Regis University.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “Navidea is pleased to add Josh, a highly respected and exceptionally talented individual, to its Board of Directors. His experience will help guide the Company through its next phases of growth and development.”
Navidea Board Chair Alexander L. Cappello said, “I am proud to welcome Josh to the Navidea Board of Directors. His management experience as an executive officer, success in capital raises and finance, demonstrated leadership, and board experience combine to make him an excellent addition to Navidea.”
Navidea also announced that its 2022 Annual Meeting of Stockholders (“2022 Annual Meeting”) will be held on Thursday, December 8, 2022 at 1:00 pm Eastern Standard Time. The 2022 Annual Meeting will be a completely virtual meeting conducted via webcast. The Board of Directors has fixed the close of business on October 10, 2022 as the record date for the determination of stockholders entitled to notice of and to vote during the 2022 Annual Meeting and any adjournment thereof.
Because the date of the 2022 Annual Meeting is more than 30 days after the anniversary of the 2021 Annual Meeting of Stockholders, the Company is providing notice of the due date for the submission of any qualified stockholder proposals or qualified stockholder director nominations with respect to the 2022 Annual Meeting.
In accordance with Rule 14a-8 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), any stockholder proposal intended to be considered for inclusion in the Company’s proxy materials for the 2022 Annual Meeting must be delivered to, or mailed to and received at, the Company’s executive offices located at 4995 Bradenton Avenue, Suite 240, Dublin, Ohio 43017, Attention: Corporate Secretary, on or before the close of business on October 10, 2022, which the Company has determined to be a reasonable time before it expects to begin to print and distribute its proxy materials for the 2022 Annual Meeting. In addition to complying with this deadline, stockholder proposals intended to be considered for inclusion in the Company’s proxy materials for the 2022 Annual Meeting must also comply with all applicable SEC rules, including Rule 14a-8 of the Exchange Act.
Pursuant to the Company’s Bylaws, any stockholder seeking to raise a proposal outside the processes of Exchange Act Rule 14a-8 or make a director nomination for consideration at the 2022 Annual Meeting must comply with the requirements of the Bylaws, including delivering such proposals and/or nominations to the executive offices of the Company located at 4995 Bradenton Avenue, Suite 240, Dublin, Ohio 43017, Attention: Corporate Secretary, by no later than close of business on October 10, 2022. Any proposal or nomination received outside of such dates will be considered untimely and will not be considered at the 2022 Annual Meeting. Any stockholder proposal or director nomination must also comply with the rules and regulations promulgated by the SEC and the Bylaws, as applicable.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220930005107/en/
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Presentation of Results from its Two Phase 2B Clinical Trials in Rheumatoid Arthritis at Upcoming American College of Rheumatology Annual Meeting
DUBLIN, Ohio, September 15, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the results from the Company’s completed NAV3-31 Phase 2B clinical study as well as the preliminary results of its ongoing NAV3-32 Phase 2B study have been accepted for presentation as posters at the Annual Meeting of the American College of Rheumatology ("ACR"), to be held November 10-14, 2022 in Philadelphia, PA (virtual and in person) ("ACR Convergence 2022").
In the completed NAV3-31 Phase 2B study (NCT03938636) titled "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" (Abstract #1977), 30 rheumatoid arthritis ("RA") patients with active RA set to start anti-tumor necrosis factor alpha ("TNFa") therapy were enrolled and followed for 24 weeks. Tc99m tilmanocept ("TIL") imaging performed at baseline and week 5 following therapy initiation had high overall accuracy at predicting American College of Rheumatology 50 ("ACR50") clinical response at 12 and 24 weeks (27/30 and 24/28 subjects, respectively) after therapy start. TIL imaging demonstrated high specificity (0.96 at weeks 12 and 24), positive predictive value (0.75 and 0.67, respectively), and negative predictive value (0.92 and 0.88, respectively), and the combination of TIL imaging data with serological and clinical markers in a multivariate model gave an area under the curve of 0.95 for prediction of response at week 24. These results indicate that marked changes in TIL uptake by week 5 presage clinical efficacy evaluations at week 12 and week 24 of treatment and demonstrate that TIL imaging can provide quantifiable imaging assessment of RA-involved joints that enables an objective, early prediction of clinical response.
In the ongoing NAV3-32 Phase 2B study (NCT04078191) titled, "A Comparison of Tc99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)" (Abstract #1979), the primary objective is to assess the relationship between joint-specific TIL uptake and the pathobiology of RA-involved joint tissue. Preliminary results on the first eleven patients indicates that quantitative TIL uptake in the hands and wrists of patients is proportional to the amount of macrophage involvement in an individual RA patient’s joint inflammation. The cellular composition of RA-inflamed joints is known to vary between patients and is frequently separated into one of three pathotypes: fibroid, diffuse myeloid, and lympho-myeloid. Knowledge of an individual RA patient’s pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond. Imaging with TIL, a high affinity ligand to CD206 expressed on activated macrophages, offers the potential to distinguish between pathotypes without need of invasive biopsy. In these preliminary results, TIL uptake in RA-inflamed joints was able to discretely differentiate patients with the fibroid pathotype (i.e., low macrophage involvement) from those having either the diffuse myeloid or lympho-myeloid pathotypes of RA (i.e., higher macrophage involvement). This could have significant implications for decision making onto which therapy a patient is placed.
Overall, data from these two studies supports the hypothesis that TIL imaging has the potential to provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working or likely to work. This could bring significant benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is currently possible.
Abstracts and presentation session information can be found on the ACR Annual Meeting website at:
https://acrabstracts.org/abstract/tc99m-tilmanocept-imaging-predicts-clinical-response-in-rheumatoid-arthritis-patients-beginning-new-anti-tnf%ce%b1-therapy/
and
https://acrabstracts.org/abstract/tc99m-tilmanocept-imaging-can-differentiate-the-fibroid-pathotype-of-rheumatoid-arthritis-from-non-fibroid-pathotypes-in-patients/
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these results with our collaborators at this internationally recognized meeting." Dr. Rosol continued, "As we continue to enroll both in the NAV3-32 TIL imaging-to-biopsy study as well as the NAV3-33 Phase 3 study in RA, this is the type of external validation of our work that reflects the recognized medical need for a robust, objective, noninvasive means of predicting clinical response to anti-TNFa therapies."
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 American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220915005677/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Opening of Nine New Sites in its Pivotal Phase 3 Trial in Rheumatoid Arthritis and Termination of Binding Memorandum of Understanding with Jubilant Radiopharma
DUBLIN, Ohio, September 01, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the opening of nine additional sites for recruitment into its pivotal NAV3-33 Phase 3 clinical trial titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)." A total of 12 sites open for the NAV3-33 study will enable faster patient enrollment and data gathering.
This Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in rheumatoid arthritis ("RA") patients switching to an anti-TNFa therapy. Trial details are posted on clinicaltrials.gov.
RA is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients initiating new RA therapies over a course of three to six months and, in those patients for which the new therapies prove to be ineffective, to change their treatments to an alternative therapy with a different mechanism of action. This trial-and-error process of appropriate treatment selection may take several months to more than a year to arrive at an adequate treatment for any RA patient. Imaging with Tc99m tilmanocept, a synthetic molecule with high affinity to CD206 receptors expressed on activated macrophages, offers the potential to provide an early predictor of clinical response by providing an objective, quantifiable readout of changes in macrophage density in the joints of patients undergoing initiation or change of therapy. These macrophage density changes may be observable weeks before disease modification can be detected with standard clinical assessments and are predictive of treatment response.
Tilmanocept imaging could provide rheumatologists and those suffering from RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working, and this could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is currently possible.
The Company also announced the termination of the Memorandum of Understanding ("MOU") with Jubilant Radiopharma, originally signed on August 9, 2020. The MOU with Jubilant Radiopharma outlined the terms and framework for an Exclusive License and Distribution Agreement for Navidea’s diagnostic imaging agent Tc99m tilmanocept (technetium Tc99m 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. Since the original signing of the MOU, Navidea has advanced Tc99m tilmanocept for indications in RA through its Phase 2B proof of concept trial and into the currently enrolling Phase 3 trial as well as the Phase 2B tilmanocept joint localization to joint biopsy study.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We have generated significant data in support of our hypotheses that Tc99m tilmanocept can provide early prediction of treatment response to anti-TNFa therapy in RA, and we look forward to the completion of the RA trials. The additional new sites we have opened will help significantly in this process." Dr. Rosol continued, "Moving forward unencumbered by the exclusivity agreement, we now have the opportunity to discuss partnerships with other companies whose long-term interests align with our global business development strategy as we continue to advance towards U.S. Food and Drug Administration New Drug Application submission and beyond."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 enabling 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220901005305/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Oral Ruling in Case Involving Attorney’s Fees
September 01 2022 - 08:00AM
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on August 30, 2022, the District Court of Harris County, Texas (the “Court”) made an oral ruling from the bench in open court at the conclusion of the trial in Case No. 2018-24442-151; Capital Royalty Partners II, L.P. et al. v. Navidea Biopharmaceuticals, Inc. and Macrophage Therapeutics, Inc., awarding Capital Royalty Group (“CRG”) $2,572,937.61 in attorney’s fees on their breach of contract claims against Navidea and Macrophage Therapeutics (“MT”).
The Court’s oral ruling did not set out the findings and conclusions made by the Court in support of the ruling; however, on November 21, 2021, the Court entered an Interlocutory Summary Judgment against Navidea and MT, ruling breach of the Global Settlement Agreement in seeking reconsideration and an appeal of the Amended Final Judgment entered by the Court in the prior case among the parties, Case No. 2016-22242-151; Capital Royalty Partners II, L.P. et al. v. Navidea Biopharmaceuticals, Inc. and Macrophage Therapeutics, Inc., and by pursuing a suit against CRG in the State of Ohio. A formal written final judgment will be entered by the Court in the case in the near future.
Navidea is disappointed in the Court’s ruling and does not believe the law and the facts presented at the trial support the ruling against it. Once a final written judgment identifying the basis and reasoning in support of the trial court’s decision is received, Navidea can better assess the Court’s judgment and determine what course of action to pursue in response to the court’s ruling.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 enabling 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220901005290/en/
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Closing of its Rights Offering and Second Quarter 2022 Earnings Conference Call and Business Update
August 30 2022 - 09:30AM
Conference Call to be Held on Thursday, September 8, 2022 at 4:00 p.m. (EDT)
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announced today the closing of its rights offering and the final results thereof.
Navidea received aggregate gross cash proceeds of approximately $6.2 million in the rights offering. If exercised, additional gross proceeds of up to $11.6 million may be received through the exercise of warrants issued in the rights offering. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $0.50 per share. In order to help maximize Navidea’s ability to use its net operating losses and other tax benefits in future years, Navidea’s board exercised its discretion to limit the number of units that John K. Scott, Jr., vice chairman of Navidea’s board, could purchase pursuant to the exchange and cancellation of his shares of Series F and Series G preferred stock. The rights offering resulted in the sale of 4,250 units pursuant to the exchange and cancellation of all outstanding shares of Navidea’s Series D and Series F preferred stock and no shares of Series G preferred stock were permitted to be exchanged by Mr. Scott.
Maxim Group LLC acted as dealer-manager for the rights offering.
The rights offering was made pursuant to the Company's registration statement on Form S-1, which was declared effective by the U.S. Securities and Exchange Commission on August 3, 2022, and the prospectus supplement dated August 18, 2022. Subscription rights that were not exercised by 5:00 p.m., Eastern Time, on August 24, 2022, have expired.
The Company also announced it will host a conference call and webcast on Thursday, September 8, 2022 at 4:00 p.m. (EDT) to discuss the rights offering, clinical developments and financial results for the second quarter ended June 30, 2022.
Dr. Michael Rosol, Chief Medical Officer, Erika Eves, Vice President of Finance and Administration, Alexander Cappello, Board Chair, and John K. Scott, Jr., Board Vice Chair, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: Second Quarter 2022 Earnings Conference Call and Business Update
Date: Thursday, September 8, 2022
Time: 4:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13732617
Webcast Link: https://www.webcast-eqs.com/navidbioph20220908/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 American: 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 https://www.navidea.com.
Note on 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, whether stated or implied, regarding our planned rights offering, financing plans and other future events. Words such as "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond our control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; 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. We undertake no obligation to update publicly or revise any forward-looking statements in this release, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220829005246/en/
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Subscriptions of Approximately $14.2 Million from its Rights Offering
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, announced today the preliminary results of its rights offering which expired at 5:00 P.M. Eastern Time on August 24, 2022. The Company estimates that the rights offering will result in total subscriptions of approximately $14.2 million. Navidea expects to receive from the rights offering aggregate gross cash proceeds of approximately $6.1 million (excluding additional proceeds of up to $15.8 million from the exercise of warrants issued in the rights offering, if any such exercises occur), and the exchange and cancellation of all of its outstanding shares of Series D, Series F and Series G preferred stock having an aggregate fair market value of $8.05 million, plus accrued dividends. The results of the rights offering are preliminary and subject to change pending finalization and verification by Navidea and its subscription agent, Broadridge Corporate Issuer Solutions, Inc.
Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one (1) share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.45 per share) and one (1) warrant to purchase 2,222 shares of Navidea’s common stock with an exercise price of $0.50 per share.
Navidea anticipates that closing of the rights offering will occur on or about August 29, 2022, subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book-entry form or through the facilities of DTC, as applicable, shares of its Series I convertible preferred stock and warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders.
Maxim Group LLC acted as dealer-manager for the rights offering. Questions about the rights offering or requests for copies of the preliminary and final prospectuses may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via email at mailto://syndicate@maximgrp.com or telephone at (212) 895-3745.
The Company's registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on August 3, 2022. The prospectus relating to and describing the terms of the rights offering has been filed with the SEC as a part of the registration statement and is available on the SEC's web site at http://www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://www.navidea.com.
Note on 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, whether stated or implied, regarding our planned rights offering, financing plans and other future events. Words such as "will," "may," "could," "should," "plan," "continue," "designed," "goal," "forecast," "future," "believe," "intend," "expect," "anticipate," "estimate," "project," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond our control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including, among other things: our history of operating losses and ability to obtain additional financing; our ability to continue as a going concern; 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. We undertake no obligation to update publicly or revise any forward-looking statements in this release, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220825005466/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
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NEWS -- Navidea Biopharmaceuticals Announces Publication of Study Examining Use of Tc99m Tilmanocept for Lymphatic Mapping and Sentinel Lymph Node Biopsy in Melanoma and Oral Cancer in Australia
DUBLIN, Ohio, August 01, 2022--(BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the publication of a manuscript titled "Tilmanocept as a novel tracer for lymphatic mapping and sentinel lymph node biopsy in melanoma and oral cancer," based on work performed at the Crown Princess Mary Cancer Centre ("CPMCC") at the University of Sydney, in Sydney, Australia. The research, appearing in the ANZ Journal of Surgery (PMID: 35848587), was led by Principal Investigator Dr. Muzib Abdul-Razak, MBBS, FRACS, FRCSE, MCh., of the Faculty of Medicine, Department of Surgical Oncology and Head and Neck Surgery in the CPMCC at the University of Sydney.
Sentinel lymph node biopsy ("SLNB") is widely accepted as an important clinical step in staging cutaneous melanoma ("CM") and is also a validated procedure to stage the neck in oral cavity squamous cell carcinoma ("OCSCC"). Despite this widespread acceptance, several different radiocolloids and dyes have been used, resulting in a non-standardized method of localizing and retrieving sentinel lymph nodes. Tc99m tilmanocept (approved as "Lymphoseek" in the US, EU, and the United Kingdom; "Lymphoaim" in India) was developed to overcome limitations of radiocolloids (lack of specific binding sites in the lymph nodes, for example, resulting in higher than desired false negative rates in some studies) and acts by selectively targeting and binding CD206 receptors on the surface of macrophages and dendritic cells. The use of Tc99m tilmanocept as a radiopharmaceutical for SLNB in CM and OCSCC has not been studied in Australia to date. This prospective study had as its aim the investigation of Tc99m tilmanocept use to evaluate its application, suitability, and reliability in an Australian setting.
A total of thirty-five patients were included in this study (N=26 with CM; N=9 with OCSCC). Lymphoscintigraphy with Tc99m tilmanocept identified at least 1 SLN (sensitivity of 100%) in all patients. There was a 100% intraoperative retrieval rate of SLNs in all patients, with positive nodes found in 20% of patients. Tc99m tilmanocept also demonstrated high tissue specificity (100%), with lymph nodal tissue confirmed histologically, with no false positives.
This is the first study to evaluate the use of Tc99m tilmanocept in the Australian setting, adding to a growing list of studies worldwide, and further supports that Tc99m tilmanocept is a reliable radiotracer for assessing the nodal status in patients with CM and OCSCC.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted to see the continued exploration of the utility of Lymphoseek for sentinel node biopsy in solid tumors. This study provides further support that Lymphoseek can provide high sensitivity and specificity for detection of sentinel nodes and supports our continued expansion of Lymphoseek outside of North America."
Dr. Abdul-Razak said, "This first-of-its-kind study in the Australian setting provides additional evidence that Tc99m tilmanocept based lymphoscintigraphy is both a feasible and an accurate method for assessing nodal status in patients with CM and OCSCC. Furthermore, our study adds to the growing body of literature supporting its use for these indications."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220801005761/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Reminds Investors of Today’s Deadline to be a Shareholder of Record for the Previously Announced Rights Offering
To be a shareholder of record, investors are advised to own Navidea Biopharmaceuticals stock by 4:00 PM ET, Monday, August 1, 2022 to account for T+2 settlement timing
Record date established as Wednesday, August 3, 2022
DUBLIN, Ohio, August 01, 2022--(BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today issued a reminder to shareholders that the record date of its proposed rights offering is Wednesday, August 3, 2022 ("Record Date"). To be a shareholder of record on the Record Date, ownership of Navidea stock must occur by market close on Monday, August 1, 2022 to account for settlement. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.
The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.
The expected calendar for the rights offering is as follows:
NEWS -- Navidea Biopharmaceuticals Announces Publication of Study Examining Tc99m Tilmanocept Imaging of Arterial Inflammation in People with HIV
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the publication of a manuscript titled “Increased Macrophage Specific Arterial Inflammation Relates Uniquely to Non-calcified Plaque and Specific Immune Activation Pathways in People with HIV: A Targeted Molecular Imaging Approach,” based on work performed at the Massachusetts General Hospital (“MGH”) and Harvard Medical School, Boston MA, and sponsored by the Company. The research, appearing in The Journal of Infectious Diseases (PMID: 35856671), was led by Principal Investigator Steven Grinspoon, MD, Chief of the Metabolism Unit at Mass General Hospital and Professor of Medicine at Harvard Medical School.
Persistent immune activation and downstream macrophage-specific arterial infiltration are thought to contribute to increased atherosclerotic (plaque) cardiovascular disease risk among people with HIV on anti-retroviral therapy (“ART”). In this study, Tc99m tilmanocept imaging was applied to investigate macrophage-specific arterial inflammation among participants with versus matched participants without HIV. The hypothesis was that people with HIV would demonstrate higher levels of aortic arterial inflammation in relation to atherosclerotic plaque and immune activation.
Results showed that patients with HIV on antiretroviral therapy (N=20) had significantly higher macrophage-specific arterial inflammation demonstrated by Tc99m tilmanocept than risk-matched people without HIV (N=10). Total, non-calcified, and calcified aortic plaque volume calculated from CT scans did not differ significantly between groups. Macrophage-specific arterial inflammation related to non-calcified plaque among HIV patients (and not among participants without HIV) and additionally related to levels of specific inflammatory markers. Aortic Tc99m-tilmanocept uptake was significantly higher across different uptake thresholds among participants with HIV (P=0.03) and demonstrated a steeper relationship between arterial inflammation and non-calcified plaque volume (P=0.0001 for interaction between HIV-status and plaque volume) but not calcified plaque volume (P=0.83 for interaction). Among people with HIV (and not among participants without HIV), non-calcified aortic plaque volume related directly with aortic Tc99m-tilmanocept uptake at different uptake thresholds.
Macrophage-specific arterial inflammation, quantified using a novel molecular imaging approach, was higher among patients with HIV on ART compared to matched participants of similar atherosclerotic cardiovascular risk without HIV. Arterial inflammation related to non-calcified plaque volume only among patients with HIV. Cellular biomarkers of inflammation also related to macrophage-specific arterial inflammation. These key immune pathways may contribute to heightened cardiovascular disease risk among people with HIV and are thus of relevance to identifying novel therapies.
These data suggest increased macrophage-specific arterial inflammation of noncalcified plaque may be a mechanism of increased cardiovascular risk in people with HIV. Use of Tc99m tilmanocept imaging may help to identify future targets for novel immunomodulatory therapies to reduce atherosclerotic cardiovascular disease risk among people with HIV on ART.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are pleased to have helped sponsor this important work with Dr. Grinspoon at MGH. This is another in a line of research collaborations we have had with the highest level of researchers at top tier institutions.” Dr. Rosol continued, “Today’s announcement exemplifies the broad reach of our tilmanocept platform. The development of applications of Tc99m tilmanocept as a biomarker in people with HIV could have far-reaching implications for monitoring patient treatment and making decisions about therapeutic benefit.”
Dr. Grinspoon said, “This study provides another key piece of evidence of increased arterial inflammation in relationship to monocyte and activation and key innate immune activation pathways in people living with HIV. Tilmanocept may be useful to assess novel immunomodulatory strategies to reduce inflammation and improve risk of cardiovascular disease in PWH.”
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220725005209/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Informs Stockholders of Key Dates and Terms Related to Announced Rights Offering
DUBLIN, Ohio, July 20, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today provided an informational update to stockholders regarding its proposed rights offering and the expected key dates and terms relative to the offering. Stockholders of record on August 3, 2022 (the "Record Date") will be entitled to participate in the rights offering. Prospective stockholders who wish to participate in the rights offering are advised to ensure that they complete their open market purchases of Navidea’s common stock by August 1, 2022 to be considered a stockholder of record on the Record Date. Holders of certain of our outstanding warrants, Series D preferred stock and Series F preferred stock are also entitled to participate in the rights offering.
Stockholders, warrant holders, preferred holders or interested parties are advised to direct all questions and informational requests to the contacts listed below.
Under the rights offering, Navidea will distribute one non-transferable subscription right for each one (1) share of common stock, each one (1) warrant and each one (1) share of preferred stock (on an as-if-converted-to-common-stock basis) held on the Record Date. Each subscription right will entitle the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of the Company’s newly created Series I Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of Navidea’s common stock at a conversion price of $0.75 per share) and one (1) warrant to purchase 1,333 shares of Navidea’s common stock with an exercise price of $0.80 per share. The warrants will be exercisable for 5 years after the date of issuance.
The subscription rights will be non-transferable and may only be exercised during the anticipated subscription period of August 4, 2022 through 5:00 PM ET on August 17, 2022, unless extended by Navidea.
The expected calendar for the rights offering is as follows:
NEWS -- Navidea Biopharmaceuticals Announces Additional Bridge Loan Funding
DUBLIN, Ohio, July 05, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on July 1, 2022, its largest shareholder and Vice Chair of the Board of Directors, John K. Scott, Jr., funded an additional $1.0 million under the secured bridge loan that was executed on April 10, 2022.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted to have the continued funding in place from Mr. Scott to keep our Phase 3 and R&D efforts moving forward."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 ability to obtain additional financing; our ability to continue as a going concern; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220705005312/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Acceptance of Abstract for Presentation at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting
DUBLIN, Ohio, May 24, 2022--(BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced acceptance of its abstract titled, “TAM Targeted Imaging Agents Binding CD206 and Selective Blocking of Off Target Liver Localization” for presentation at this year’s Society of Nuclear Medicine and Molecular Imaging (“SNMMI”) Annual Meeting. This work was performed as part of an ongoing research collaboration with the University of Alabama at Birmingham (“UAB”), in the laboratory of Dr. Suzanne Lapi, Professor and Vice Chair of Research in the UAB Department of Radiology. The poster will be presented by Dr. Jennifer Bartels of UAB.
This year’s annual SNMMI meeting will be held June 11-14 in Vancouver, British Columbia, Canada. The presentation will take place Saturday, June 11, from 6 pm – 8 pm PDT (abstract ID 197; program ID 2862). The abstract will be accessible on the SNMMI’s Annual Meeting website prior to the meeting (https://am.snmmi.org/iMIS/SNMMI-AM).
The objectives of this preclinical study were to evaluate tumor localization of two new CD206 targeted mannosylated dextran (Navidea’s Manocept platform) imaging agents as well as an approach to reduce uptake of these imaging agents by the liver. The new imaging agents were labeled with gallium-68 (“68Ga”) to enable positron emission tomography (“PET”) imaging. The ultimate goals are to develop next generation Manocept imaging agents that offer improved on-target localization and reduced off-target localization. CD206 is a receptor expressed primarily on activated macrophages, including tumor associated macrophages (“TAMs”), as well as the Kupffer cells of the liver. TAM-targeted Manocept imaging enables imaging of tumors. The information gained from these experiments also suggests strategies to improve targeted delivery of therapeutic payloads to TAMs and other clinically significant targets, while simultaneously reducing off-target liver toxicity.
The experiments described in the poster evaluated the biodistribution in mice with and without tumors of the new 68Ga-labeled Manocept imaging agents that differed in their molecular weights. Also evaluated were the effects on their biodistributions of prior administration of unlabeled constructs or a construct designed to specifically block off-target liver localization. Results showed that the amount of the two imaging agents that localized to tumors differed significantly. Also, pretreatment with the construct designed to selectively block liver localization did significantly reduced liver localization of the 68Ga-labeled imaging agents without reducing their localizations to tumors.
Dr. Suzanne Lapi said, “My research group and I are pleased to present this collaborative work with Navidea at SNMMI and to continue to further advance this project with possible far reaching medical imaging and commercial potentials.”
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted by the opportunity to present these results at this internationally recognized meeting.” Dr. Rosol continued, “This is another example in a line of research collaborations we have had with the highest level of researchers at top tier institutions that is resulting in work advancing our platform technology. These new technologies suggest exciting new applications in medical imaging and possibly also new therapeutic strategies.”
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://www.navidea.com.
About UAB
Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with over $600 million in research awards annually, as well as Alabama’s largest single employer, with some 26,000 employees, and has an annual economic impact exceeding $7.15 billion on the state. The pillars of UAB’s mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at https://www.uab.edu.
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 ability to obtain additional financing; our ability to continue as a going concern; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220524005401/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Acceptance of Abstract for Presentation at the Tumor Myeloid-Directed Therapies Summit Annual Meeting
DUBLIN, Ohio, May 23, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced acceptance of its abstract titled, "CD206 Targeted Delivery of Bisphosphonate Payloads Alter Human Macrophage Phenotypes Towards M1-like" for presentation of a poster at this year’s Tumor Myeloid-Directed Therapies Summit.
The 2nd annual Tumor Myeloid-Directed Therapies Summit meeting will be held June 14-16, 2022 in Boston, MA. The presentation will take place Tuesday, June 14. Meeting information can be found on the conference website (https://tumor-myeloid-therapeutics.com).
The poster will present information related to the synthesis of two novel bisphosphonate drugs that have been attached to Navidea’s CD206-targeted drug delivery platform molecule, Manocept. These constructs use a novel degradable linker to release the therapy only once they have been internalized into a CD206-expressing cell, such as a tumor associated macrophage. The new therapeutic constructs were evaluated in human macrophage cell culture assays to compare the ability of the new constructs with unbound free therapy to shift the phenotype of macrophages toward a proinflammatory gene expression pattern. The new drug delivery constructs successfully shifted the phenotypes of human macrophages towards a proinflammatory state and compared favorably to the unbound free therapy. The new drug constructs also induced a highly significant reduction in macrophage expression of signal regulatory protein alpha ("SIRPa"), the receptor for the "don’t eat me" signal that, when activated, suppresses the ability of macrophages to attack and phagocytize disease associated cells such as cancer cells. The ability to induce this type of phenotypic change in macrophages could have far-reaching applications in cancer immunotherapy.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "These new therapeutic constructs demonstrate the power of our adaptable platform technology to deliver a wide array of small molecule payloads in a targeted fashion to macrophages involved in the propagation of a variety of severe illnesses including cancer."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 ability to obtain additional financing; our ability to continue as a going concern; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220523005345/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Reports First Quarter 2022 Financial Results
Conference Call to be held Thursday, May 12, 2022 at 5:00 pm (EDT)
DUBLIN, Ohio, May 12, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the first quarter for the period ended March 31, 2022.
First Quarter 2022 Highlights and Subsequent Events
NEWS -- Navidea Biopharmaceuticals to Host First Quarter 2022 Earnings Conference Call and Business Update
Conference Call to be Held on Thursday, May 12, 2022 at 5:00 p.m. (EDT)
DUBLIN, Ohio, May 05, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: 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, May 12, 2022 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the first quarter ended March 31, 2022.
Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: First Quarter 2022 Earnings Conference Call and Business Update
Date: Thursday, May 12, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 800-285-6670
International Dial-In: +1 713-481-1320
Conference ID: 512400
Webcast Link: https://www.webcast-eqs.com/navidbioph20220512/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at https://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 American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220505005249/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
LIFESCI PARTNERS (complete) REPORT
http://archive.fast-edgar.com/20220420/A3ZXM22CZ222A2ZZ2U2F2MZZCWGSZ6Y8Z242/
Would like to see market price based on these numbers. Oh, yeah, and a little respect for the original Lymposeek market
NEWS -- Navidea Biopharmaceuticals Announces Positive Preliminary Results of Its Ongoing Phase 2B Study Comparing Tc99m Tilmanocept Imaging with Histopathology of Joints from Patients with Rheumatoid Arthritis
Data support hypothesis that Tc99m tilmanocept imaging can differentiate fibroid pathotype of rheumatoid arthritis from non-fibroid pathotypes
DUBLIN, Ohio, April 20, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced preliminary results from the ongoing NAV3-32 Phase 2B study titled, "A Comparison of Tc99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)." Preliminary results on the first eleven patients indicates that quantitative Tc99m tilmanocept uptake in the hands and wrists of patients is proportional to the amount of macrophage involvement in an individual rheumatoid arthritis ("RA") patient’s joint inflammation. Additionally, Tc99m tilmanocept uptake in RA-inflamed joints was able to discretely differentiate patients with the fibroid pathotype (i.e., low macrophage involvement) from those having either the diffuse myeloid or lympho-myeloid pathotypes of RA (i.e., higher macrophage involvement).
The primary objective of this study is to assess the relationship between joint-specific tilmanocept uptake values and the pathobiology of RA-involved joint tissue. This is being accomplished by taking biopsy samples from joints of patients with RA following imaging with Tc99m tilmanocept. The images are being evaluated using Navidea’s proprietary imaging analysis method to determine the amount of Tc99m tilmanocept uptake in the joint to be biopsied. The biopsy tissues are being evaluated by a pathologist using immunohistochemical ("IHC") staining to determine the cellular composition, including macrophage content, in the inflammatory tissue of the RA-involved joint. The cellular composition of RA-inflamed joints is known to vary between patients and is frequently separated into one of three pathotypes termed fibroid, diffuse myeloid, and lympho-myeloid. Knowledge of an individual RA patient’s pathotype may be clinically important because it may predict to which RA therapy a patient is likely to respond. It is Navidea’s hypothesis that the imaging signal will correlate with the number and density of activated macrophages in the joints of RA patients, and that this imaging signal can provide important information about not only the disease status of the patient, but also indicate which pathotype of RA that the patient has. Enrollment is to continue until a minimum of four patients of each of the three pathotypes- fibroid, diffuse myeloid, and lympho-myeloid- have been enrolled and had both assessable imaging and biopsy performed.
At the current time, a total of eleven patients have had Tc99m tilmanocept imaging followed by synovial tissue biopsy in an inflamed joint of their hands or wrists. Quantitative image analysis was performed prior to biopsy. Image analyses conducted before the biopsies has been able to separate the subjects into at least 2 distinct and nonoverlapping classes of subjects. Seven of the subjects had relatively lower levels of Tc99m tilmanocept uptake. All seven of these subjects were found to have the fibroid pathotype. Of the remaining 4 subjects, 3 had the diffuse myeloid pathotype and 1 had the lympho-myeloid pathotype. Furthermore, those subjects with either the diffuse myeloid or lympho-myeloid pathotypes had, on average, more than 3 times more Tc99m tilmanocept uptake as the average subject with the fibroid pathotype. The pathologist who evaluated these biopsies was blinded to the imaging results prior to completing their report. These early results support the hypothesis that those patients with low levels of Tc99m tilmanocept localization in their hand and wrist joints have the fibroid pathotype of RA, and those with higher levels of localization are representative of one of the other two pathotypes.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are encouraged by these preliminary results. They support one of our main hypotheses- that the joints of patients with the pathotype of RA involving low levels of synovial macrophages, the fibroid pathotype, have low levels of Tc99m tilmanocept uptake, while those with the other pathotypes have relatively higher levels." Dr. Rosol continued, "We believe that this Phase 2B study is critical for establishing the definitive relationship of our imaging readout to the underlying pathobiology of an RA-involved joint, as well as to assess our hypothesis that we can use Tc99m tilmanocept imaging to classify RA subtype. This information may further assist physicians to determine what type of therapy might be most beneficial for a given patient earlier and more noninvasively than is currently possible. This study will also be important for us as we seek to achieve qualification with the FDA of CD206 as a biomarker for RA."
The Company will hold a business update conference call today, Wednesday, April 20, 2022, at 5:00 p.m. (EDT). Chief Medical Officer Dr. Michael Rosol will host the call and webcast.
To participate in the first call and webcast, please refer to the information below:
Event: Navidea Business Update – Company Strategy and Clinical Update
Date: Wednesday, April 20, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13729076
Webcast Link: https://www.webcast-eqs.com/navidbioph20220420/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at https://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.
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 American: 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 https://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 ability to obtain additional financing; our ability to continue as a going concern; 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.
These forward-looking statements include, but are not limited to, statements about preliminary data from Navidea’s ongoing clinical trials. Data from the NAV3-32 Phase 2B clinical trial are preliminary and will require confirmation in additional patients as well as further analyses to draw any clinical conclusion. Preliminary data from Navidea’s clinical trials that it announces or publishes from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220420005414/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Updated Third-Party Asset Valuation of Tc99m Tilmanocept for Indications in Rheumatoid Arthritis for U.S. and EU Markets
DUBLIN, Ohio, April 20, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the results of an updated third-party asset valuation of its Rheumatoid Arthritis ("RA") diagnostic product candidate for both the U.S. and EU markets.
The Company engaged the independent third-party valuation firm, LifeSci Consulting (LifeSci Partners), to perform a U.S.-focused primary market research valuation and a secondary market analysis for the EU of its advanced pipeline product Tc99m tilmanocept for prediction of treatment efficacy of anti-tumor necrosis factor alpha ("TNFa") therapy in RA. A summary of the valuation report and the assumptions on which it is based is available on the Company’s website, https://www.navidea.com. The U.S. market evaluation has been updated from the December 2021 press release using primary information from academic and high-volume health care provider rheumatologists obtained through questionnaires and interviews (primary research).
The Company is advancing its program evaluating Tc99m tilmanocept imaging, a radiopharmaceutical that selectively targets the CD206 receptor expressed on activated macrophages, for indications in RA. A previously completed Phase 2B study demonstrated results in support of the hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. The Company’s active Phase 3 trial will evaluate the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNFa therapy.
The valuation report used cited research and assumptions believed to conform to industry best practices. Under base-case assumptions that are discussed in the report, peak combined U.S. and EU sales could reach $1.2 billion annually, and in the upside scenario peak annual U.S. and EU sales could reach $2.6 billion. Rheumatologist feedback included recognition of the need for a tool that would enable treatment response prediction. Opportunities for added value include possible indication expansion to other classes of RA therapeutics, registration of Tc99m tilmanocept imaging as a biomarker of activated macrophages in the joints of patients with RA, and expansion into additional geographic areas.
Dr. Michael Rosol, Navidea’s Chief Medical Officer, said, "This report provides an updated third-party assessment of the potential commercial value of Tc99m tilmanocept in both the U.S. and EU markets. As with our earlier release, we present this in the spirit of transparency, while also giving investors a view into the company’s internal rigor in evaluating investments in the product pipeline." Dr. Rosol continued, "We believe we are on the right path to bringing a valuable tool to bear to meet a large unmet medical need in patients with RA. Success would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment much earlier than is possible today."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 fact that the valuation by LifeSci Partners of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions about the commercial success of the product, expected associated costs, and the outcome of various risks, including the outcome of clinical trials, that could affect the timetable for revenues, among other assumptions, that actual outcomes are likely to vary from such assumptions, resulting in variations from the possible results set forth in the valuation report; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220420005182/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces the Notice of Allowance for U.S. Patent Application for Diagnosis and Treatment of Leishmaniasis
Decision of Grant given in Japan for separate patent application covering targeted delivery of payloads attached to the Manocept platform
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that it has received a Notice of Allowance for the patent application titled, “Compounds And Compositions For Treating Leishmaniasis And Methods Of Diagnosis And Treating Using Same” (U.S. Patent Application No. 15/729,633). Navidea also announced that it has received a Decision of Grant from the Japan Patent Office for the patent application titled, “Compounds And Compositions For Targeting Macrophages And Other Mannose-Binding C-Type Lectin Receptor High Expressing Cells And Methods Of Treating And Diagnosing Using Same” (Japanese Patent Application No. 2020-107176).
The U.S. patent application involving leishmaniasis protects the use of Navidea’s mannosylated dextran-based drug-delivery vehicles to deliver small molecule therapeutic payloads as possible therapies for leishmaniasis. Leishmaniasis is a vector-borne chronic disease caused by a protozoan parasite that replicates in CD206+ macrophages. It is transmitted to humans through the bite of infected phlebotomine sandflies found in parts of the tropics, subtropics, and southern Europe. Leishmaniasis is rare in the U.S., but in more tropical countries where the sandfly vectors are found, leishmaniasis is a common, serious, and potentially life-threatening disease. The World Health Organization estimates that there are 700,000-1,000,000 new cases of leishmaniasis each year. Because of this situation, leishmaniasis is classified as a neglected tropical disease, and is on the FDA’s list of tropical diseases eligible to receive a priority review voucher. If further research supports the efficacy of Navidea’s therapeutic constructs for treating leishmaniasis, the awarding of a priority review voucher could have significant economic value for Navidea. The Notice of Allowance concludes the substantive examination of the patent application and is expected to result in the issuance of a U.S. patent after administrative processes are completed.
The Japanese patent application titled “Compounds And Compositions For Targeting Macrophages And Other Mannose-Binding C-Type Lectin Receptor High Expressing Cells And Methods Of Treating And Diagnosing Using Same” is an important application for Navidea that claims targeted delivery of a wide range of therapeutic payloads attached to Manocept platform-based constructs using a degradable hydrazone linker. The Japanese patent application has similar claims to a corresponding patent that was previously granted in the U.S. Ongoing work by Navidea has shown that the claimed Manocept-hydrazone constructs have potential applications for treating such diseases as cancer as well as leishmaniasis. The Japanese Patent Office Decision of Grant for this patent application strengthens Navidea’s patent protection for the therapeutic constructs it is developing.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “These patents will be key to advancing and protecting our intellectual property and to the continued development of our clinical pipeline. Our targeted therapeutics have the potential to address the large unmet medical need caused by leishmaniasis as well as other diseases of significance globally.”
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220419005384/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces the Regulatory Approval of Lymphoaim in India
DUBLIN, Ohio, April 18, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the regulatory approval of Lymphoaim ("Lymphoseek" in the rest of the world; Tc99m tilmanocept) by the Central Drugs Standard Control Organisation, India.
Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
Sayre Therapeutics will lead Lymphoaim commercialization efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specializes in innovative treatment and medical device commercialization in South Asia.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted that Lymphoaim has received regulatory approval in India and will be available to patients in need." Dr. Rosol continued, "This will also bring a new revenue stream to the Company to help us advance other pipeline products."
Mr. Shukrit Sudhir Chimote, Chief Executive Officer for Sayre, said, "Lymphoaim, a radioactive diagnostic agent, would benefit surgeons in guiding sentinel lymph node biopsies. This product fits well with Sayre’s mission of providing novel treatment solutions, and will certainly help boost our presence in the surgical oncology segment."
About Sayre Therapeutics
Sayre Therapeutics Private Ltd. is South Asia’s integrated platform for disease management backed by a unique distribution and commercialization model for novel and / or differentiated drugs, companion diagnostics, and drug-delivery devices in the super-specialty areas of Oncology and Immunology.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220418005445/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Adoption of Plan Designed to Protect NOLs and Other Tax Assets, Closing of Bridge Loan Financing, and Business Update Q&A Series
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that its Board of Directors has adopted a Section 382 Rights Agreement that is designed to protect the availability of the Company’s net operating loss carryforwards (“NOLs”) and other tax assets (“Section 382 Rights Plan”), and that it has entered into a stock exchange and loan agreement with the Company’s largest shareholder and Vice Chair of the Board of Directors (the “Board”), John K. Scott, Jr., pursuant to which, among other things, Mr. Scott has agreed to provide an initial $1.5 million in bridge loan funding. The Company will host two Business Update Question and Answer calls to discuss these and other matters.
As of December 31, 2021, Navidea had approximately $164 million of U.S. federal NOLs and approximately $9.1 million of R&D tax credits that could be available to offset its future federal taxable income. Navidea’s ability to use these NOLs as well as other tax attributes would be substantially limited if it experienced an “ownership change” within the meaning of Section 382 of the Internal Revenue Code. In general, a company would undergo an ownership change if its “5-percent shareholders” (determined under Section 382) increased their ownership of such company’s stock by more than 50 percentage points over a rolling three-year period. The Section 382 Rights Plan is intended to reduce the likelihood of such an ownership change at Navidea by deterring any person or group from acquiring beneficial ownership of 4.9% or more of Navidea’s outstanding common stock.
Under the Section 382 Rights Plan, the Board declared a dividend of one preferred share purchase right for each share of Navidea’s common stock outstanding as of the close of business on April 12, 2022. The rights will be exercisable only if a person or group acquires 4.99% or more of Navidea’s common stock. Any person which currently beneficially owns in excess of 4.99% of Navidea’s common stock may continue to own their shares of common stock but may not acquire an additional 0.5% or more of common stock without triggering the Section 382 Rights Plan. If the rights become exercisable, all holders of rights, other than the person or group triggering the rights, will be entitled to purchase shares of common stock at a 50% discount or Navidea may exchange each right held by such holders for five shares of common stock. The Board has the discretion to exempt any person or group from the provisions of the Section 382 Rights Plan. The Company may seek shareholder approval of the Section 382 Rights Plan at its next annual meeting of stockholders.
The Company and Mr. Scott have agreed to terms on a secured bridge loan of up to $2.5 million (with an initial $1.5 million of funding upon closing and the additional $1 million if and when mutually agreed) to provide working capital to the Company while further financing is sought. This bridge loan matures in two years and is not convertible, helping to protect the Company’s NOLs. As additional inducement for the bridge loan, the Company agreed to issue to Mr. Scott shares of two newly established series of preferred stock in exchange for all of Mr. Scott’s shares of Series E Preferred Stock, which effectively allows Mr. Scott to maintain all or a portion of his prior liquidation preference without further diluting the Company’s stockholders, and helping to protect the Company’s NOLs.
Alexander Cappello, the Chair of the Company’s Board of Directors, said, “The Section 382 Rights Plan puts in place appropriate measures to protect these valuable NOLs, a critical asset to the Company.” Mr. Cappello continued, “The bridge loan from Mr. Scott helps us as we continue work towards a larger financing.”
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted to have the continued funding in place to keep our clinical and R&D efforts going while we work with the Board for full funding.”
The Company will hold the business update conference calls and webcasts on Thursday, April 14, 2022, and Wednesday, April 20, 2022, both at 5:00 p.m. (EDT). Chief Medical Officer Dr. Michael Rosol will host the calls and webcasts to provide updates on recent developments and clinical progress. Mr. Cappello and Mr. Scott will join. Topics to be covered will be Financing (Thursday, April 14) and Company Strategy and Clinical Update (Wednesday, April 20).
To participate in the first call and webcast, please refer to the information below:
Event: Navidea Business Update – Financing
Date: Thursday, April 14, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13729072
Webcast Link: https://www.webcast-eqs.com/navidbioph20220414/en
Call and webcast details for Wednesday, April 20, 2022 will be provided in a future press release.
A live audio webcast of each 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 calls can be replayed and will be available for 90 days following the calls on Navidea’s website.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 ability to obtain additional financing; our ability to continue as a going concern; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220412005944/en/
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Receives Acceptance Letter from NYSE American
DUBLIN, Ohio, April 12, 2022--(BUSINESS WIRE)--As previously disclosed, on January 28, 2022, Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, received a notification from the NYSE American stating that the Company was not in compliance with the $6.0 million stockholders’ equity requirement of Section 1003(a)(iii) of the NYSE American Company Guide. As required by the NYSE American, the Company submitted a plan to the NYSE American by February 28, 2022 advising of actions it has taken or will take to regain compliance with the continued listing standards by July 28, 2023.
On April 8, 2022, the Company received notification (the "Acceptance Letter") from the NYSE American that the Company’s plan to regain compliance was accepted. The Acceptance Letter also stated that the Company is also not in compliance with Sections 1003(a)(i) and 1003(a)(ii) of the NYSE American Company Guide, which require an issuer to have stockholders’ equity of (i) $2.0 million or more if it has reported losses from continuing operations and/or net losses in two out of its three most recent fiscal years, and (ii) $4.0 million or more if it has reported losses from continuing operations in three out of its four most recent fiscal years. The Acceptance Letter noted that the Company had stockholders’ equity of $624,743 as of December 31, 2021 and has reported net losses from continuing operations in its five most recent fiscal years ended December 31, 2021.
The NYSE American has granted the Company a plan period through July 28, 2023 to regain compliance with Sections 1003(a)(i), (ii) and (iii). If the Company is not in compliance with all continued listing standards by that date or if the Company does not make progress consistent with the plan during the plan period, the NYSE American may commence delisting procedures.
Navidea’s common stock will continue to be listed on the NYSE American while it attempts to regain compliance with the listing standards noted, subject to Navidea’s compliance with other continued listing requirements. The common stock will continue to trade under the symbol "NAVB," but will have an added designation of ".BC" to indicate that Navidea is not in compliance with the NYSE American’s listing standards. The NYSE American notification does not affect Navidea’s business operations or its SEC reporting requirements and does not conflict with or cause an event of default under any of Navidea’s material agreements.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 ability to obtain additional financing; our ability to continue as a going concern; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220412005941/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces New Senior Regulatory Consultant and Return of Former Director of Regulatory Affairs
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today welcomed Kenneth Berger, Ph.D., as Senior Regulatory Consultant, and the return of the Company’s former Director of Regulatory Affairs, Richard McFerron. Navidea’s former Chief Regulatory Officer, Dr. Michel Mikhail, is no longer with the Company.
Dr. Berger brings decades of experience in regulatory, clinical, and quality management in biologics, pharmaceuticals, and medical devices to Navidea’s regulatory team. He has an extensive background involving Investigational New Drug submission for novel therapeutics, FDA regulatory package submissions including successful Special Protocol Assessment and Orphan Drug Status filings, and clinical Good Manufacturing Practice. He holds a Ph.D. from the University of Southern California. He will be actively engaged with the clinical team as well as the Company’s network of consultants in pharmacovigilance and drug product development.
Mr. McFerron has a long track record with Navidea and was involved in the successful submission of regulatory approval packages to the FDA as well as the European Medicines Agency for approval of Lymphoseek. He will work closely with Dr. Berger as well as the clinical team on advancing the Company’s Rheumatoid Arthritis (“RA”) radiopharmaceutical diagnostic through Phase 3 as well as on advancing other Manocept platform diagnostic and therapeutic agents.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are delighted to welcome Ken to the Company in a senior advisory role. Ken brings a wealth of experience in the critical areas of FDA submissions and drug product manufacturing.” Dr. Rosol continued, “We are also happy that our former Director of Regulatory Affairs is returning. Rich was a key player at Navidea for many years, including during the approval processes of Lymphoseek and more recently in our Phase 1 and 2 trials in RA. We are excited to move forward with this strong regulatory group.”
The Company also advises that its audited consolidated financial statements for the fiscal year ended December 31, 2021, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 28, 2022, contains an audit opinion from its independent registered public accounting firm that includes an explanatory paragraph related to the Company’s ability to continue as a going concern. Release of this information is required by Sections 401(h) and 610(b) of the NYSE American Company Guide. This announcement does not represent any change or amendment to the Company’s financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2021.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220407005310/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Reports Fourth Quarter 2021 Financial Results
Conference Call to be held Wednesday, March 23, 2022 at 5:00 pm (EST)
DUBLIN, Ohio, March 23, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the fourth quarter and year-to-date for the period ended December 31, 2021.
To view full source version on businesswire.com: https://www.businesswire.com/news/home/20220323005340/en/
NEWS -- Navidea Biopharmaceuticals to Host Fourth Quarter 2021 Earnings Conference Call and Business Update
Conference Call to be Held on Wednesday, March 23, 2022 at 5:00 p.m. (EDT)
DUBLIN, Ohio, March 16, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Wednesday, March 23, 2022 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the fourth quarter ended December 31, 2021.
Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: Fourth Quarter 2021 Earnings Conference Call and Business Update
Date: Wednesday, March 23, 2022
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13726541
Webcast Link: https://www.webcast-eqs.com/navidbioph20220323/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at https://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 American: 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 https://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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220316005218/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NAVB $$$$ Common stock; $.001 par value; 300,000,000 shares authorized; 30,163,245 and 27,149,691 shares issued and outstanding as of September 30, 2021
https://www.navidea.com/
NEWS -- Navidea Biopharmaceuticals Announces Research Agreement with the University of Pennsylvania Evaluating Tc99m Tilmanocept as a Prognostic Marker for Glioblastoma
DUBLIN, Ohio, February 07, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the signing of a Sponsored Research Agreement with the University of Pennsylvania ("Penn") for a project to evaluate the use of Tc99m tilmanocept imaging in glioblastoma as a prognostic agent for tumor growth rate and overall survival. The research is led by Principal Investigator Ali Nabavizadeh, MD, of the Department of Radiology in the Perelman School of Medicine at Penn.
Glioblastoma ("GBM") is the most aggressive and most common primary central nervous system tumor in adults and there is an urgent need for new therapies. Macrophages play an important role in tumor biology. They are a major population of non-cancer cells in GBM, representing as many as half of all cells in some cases. These Tumor Associated Macrophages ("TAMs") may then be a viable target for tumor therapies or serve as a biomarker for monitoring tumor status.
Broadly, active macrophages can be of a tumor suppressing type (M1 macrophages) or of a tumor promoting type (M2 macrophages). The TAMs are typically M2-like and are known to express high levels of CD206, the macrophage mannose receptor that Tc99m tilmanocept targets. This research has as its hypothesis that the M2 TAMs in GBM can be imaged with Tc99m tilmanocept, and that this imaging can serve as a predictive tool for outcome with and without use of an immunotherapy that works in part to change the M2-like macrophage population to a more M1-like state, promoting tumor killing.
In these preclinical studies, Tc99m tilmanocept imaging will be evaluated in correlation with tumor growth rate, and in separate studies Tc99m tilmanocept imaging will be performed before and after anti-interleukin-6 therapy, which has been shown to promote TAM switching from the M2 to M1 state. Study endpoints will include quantitative imaging compared to pathology and overall survival.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are pleased to sponsor this important work with Dr. Nabavizadeh at Penn. This is another in a line of research collaborations we have had with the highest level of researchers at top tier institutions." Dr. Rosol continued, "Today’s announcement exemplifies the broad reach of our tilmanocept platform. The development of applications of Tc99m tilmanocept as a prognostic biomarker in cancers could have far-reaching implications for monitoring patient treatment and making decisions about therapeutic benefit. We are excited to continue to develop new and valuable applications for our core technology."
"TAMs are a very important component of immune microenvironment in GBM, and it is crucial to have reliable imaging biomarkers to quantify and monitor TAMs during the course of treatment," Dr. Nabavizadeh said. "The advantage of Tc99m tilmanocept is that it is already being used in patients for another research indication which means that we can move forward to human GBM patients under an Investigational New Drug Application (IND) if our preclinical studies show promising results."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220207005162/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Settlement of Platinum Litigation; Receipt of Noncompliance Notice from NYSE American
DUBLIN, Ohio, February 03, 2022--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced settlement of the ongoing litigation with Platinum-Montaur Life Sciences LLC ("Platinum-Montaur"), an affiliate of Platinum Management (NY) LLC, Platinum Partners Value Arbitrage Fund L.P., Platinum Partners Capital Opportunity Fund, Platinum Partners Liquid Opportunity Master Fund L.P., Platinum Liquid Opportunity Management (NY) LLC, and Montsant Partners LLC (collectively, "Platinum").
As disclosed in the notes to the financial statements included in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, the Company has been engaged in litigation with Platinum-Montaur, in which Platinum-Montaur was seeking damages of approximately $1.9 million plus interest. On January 13, 2022, Navidea and Platinum executed a Joint Settlement, Release and Confidentiality Agreement (the "Settlement Agreement"). As a result of the Settlement Agreement, Platinum has dismissed their claims against the Company thereby ending the litigation between the parties.
NYSE American Compliance Letter
On January 28, 2022, Navidea received a letter from NYSE American LLC ("NYSE American" or the "Exchange") stating that Navidea was not in compliance with the continued listing standards as set forth in Section 1003(a)(iii) of the NYSE American Company Guide (the "Company Guide"). In order to maintain its listing, the Company must submit a plan of compliance by February 27, 2022 addressing how it intends to regain compliance with Section 1003(a)(iii) of the Company Guide by July 28, 2023. If the plan is accepted, the Company may be able to continue its listing but will be subject to periodic reviews by the Exchange. If the Company does not submit a plan or if the plan is not accepted, delisting proceedings will commence. If the plan is accepted but the Company is not in compliance with the continued listing standards by July 28, 2023, or if the Company does not make progress consistent with the plan, the Exchange may initiate delisting procedures. The Company's management is pursuing options to address the deficiency and intends to submit a compliance plan on or before the deadline set by the Exchange.
Navidea’s common stock, par value $0.001 per share ("Common Stock") will continue to be listed on the NYSE American while it attempts to regain compliance with the listing standard noted, subject to Navidea’s compliance with other continued listing requirements. The Common Stock will continue to trade under the symbol "NAVB," but will have an added designation of ".BC" to indicate that Navidea is not in compliance with the NYSE American’s listing standards. The NYSE American notification does not affect Navidea’s business operations or its SEC reporting requirements and does not conflict with or cause an event of default under any of Navidea’s material agreements.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220203005915/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Launch of Phase 3 Clinical Trial in Rheumatoid Arthritis
DUBLIN, Ohio, December 16, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the launch of the NAV3-33 Phase 3 clinical trial titled "Evaluation of Tc99m Tilmanocept Imaging for the Early Prediction of Anti-TNFa Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)."
This Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in rheumatoid arthritis ("RA") patients switching to an anti-TNFa therapy. Trial details will be posted to clinicaltrials.gov.
Rheumatoid Arthritis is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients initiating new RA therapies over a course of three to six months and, in those patients for which the new therapies prove to be ineffective, to change their treatments to an alternative therapy with a different mechanism of action. This trial-and-error process of appropriate treatment selection may take several months to more than a year to arrive at an adequate treatment for any RA patient. Imaging with Tc99m tilmanocept, a synthetic molecule with high affinity to CD206 receptors expressed on activated macrophages, offers the potential to provide an early predictor of clinical response by providing an objective, quantifiable readout of changes in macrophage density in the joints of patients undergoing initiation or change of therapy. These macrophage density changes may be observable weeks before disease modification can be detected with standard clinical assessments.
The data from the Company’s completed NAV3-31 Phase 2b trial demonstrated that Tc99m tilmanocept can provide robust, quantitative imaging in both healthy controls and in patients with active RA, and that this imaging is reproducible and can define joints with and without RA-involved inflammation. The Phase 2b also provided evidence in support of the hypothesis that Tc99m tilmanocept can provide an early prediction of treatment efficacy in patients switching to an anti-TNFa therapy.
The design of the Phase 3 trial is built upon insights and data from this completed Phase 2b study, as well as input from the recent End of Phase 2 Type B meeting with the FDA. The NAV3-33 Phase 3 trial will involve Tc99m tilmanocept imaging in patients with RA who are about to begin an anti-TNFa therapy. Planar (two-dimensional) images of the hands and wrists taken at baseline prior to initiation of therapy and at week 5 following start of therapy will be quantitatively evaluated to assess changes in Tc99m tilmanocept signal localization, if any, in order to predict treatment response or non-response as determined by standard clinical assessments at three and six months post therapy start.
Dr. Michael Rosol, the Company’s Chief Medical Officer, said, "This is a critical milestone in our RA program and for the Company as a whole. Throughout this program’s development, we have worked closely with expert rheumatologists and nuclear medicine specialists, and we believe we are on the right path to bringing a valuable tool to bear to meet a large unmet medical need in patients with RA." Dr. Rosol continued, "Success would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is possible today."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 fact that the valuation by LifeSci Partners of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions about the commercial success of the product, expected associated costs, and the outcome of various risks, including the outcome of clinical trials, that could affect the timetable for revenues, among other assumptions, that actual outcomes are likely to vary from such assumptions, resulting in variations from the possible results set forth in the valuation report; 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216006102/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Completes Full Enrollment in Phase 2b Normative Database Study to Support its Rheumatoid Arthritis Program
DUBLIN, Ohio, December 15, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that it has achieved full enrollment in its NAV3-35 Phase 2b clinical study titled "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept."
Establishing a healthy subject database is necessary to create a quantitative method for determining RA-involved inflammation in joints. The NAV3-35 Phase 2b clinical trial accomplishes this goal. The trial has two arms, with Arm 1 designed to acquire hand and wrist planar (two-dimensional) images from healthy subjects that were age and sex-matched to the RA population and injected with Tc99m tilmanocept. Arm 2 is a pilot feasibility study to examine the potential of three-dimensional SPECT/CT imaging of the hands and wrists of healthy subjects and patients with RA injected with Tc99m tilmanocept. The main objective of the trial is to complete the healthy subject (normative) database in support of the Company’s RA imaging commercial product development. A total of 120 healthy volunteers were enrolled in Arm 1. Enrollment is also finalized in Arm 2 of the study.
Tc99m tilmanocept attaches to mannose receptors (CD206) on macrophages that are frequently involved in RA joint inflammation. Relatively smaller numbers of CD206-expressing macrophages normally reside in the joints of healthy people without RA. An integral part of the ability to quantitatively discriminate RA-inflamed joints from those that do not have inflammation using Tc99m tilmanocept imaging is the knowledge of the distribution of Tc99m tilmanocept localization in healthy joints. The establishment of this database will enable improved accuracy of discrimination of RA-involved joints from non-RA inflamed joints and should have a positive impact on the ability to predict treatment response early, the primary indication the Company is pursuing in RA in the upcoming Phase 3 trial.
This database will also be used in the training of automated image analysis software to further improve the accuracy of the quantification of Tc99m tilmanocept localization in joints as well as the workflow for later commercialization in RA.
Dr. Michael Rosol, the Company’s Chief Medical Officer, said, "We are pleased to have reached this important milestone in our RA program pipeline. This healthy subject normative database will allow us to define the parameters of what a normal joint looks like with Tc99m tilmanocept, and with that information we can improve upon the quantitative determination of RA-inflamed joints." Dr. Rosol continued, "This database will play an essential part in both the Phase 3 data analysis as well as commercial product. It will not only enable us to more accurately quantitate RA-involved inflammation but, along with the proprietary algorithm we use to read the images, it will serve as an additional barrier to entry for possible long-term competition. This is a critical step forward in the advancement of our RA program into the upcoming Phase 3 trial."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 fact that the valuation by LifeSci Partners of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions about the commercial success of the product, expected associated costs, and the outcome of various risks, including the outcome of clinical trials, that could affect the timetable for revenues, among other assumptions, that actual outcomes are likely to vary from such assumptions, resulting in variations from the possible results set forth in the valuation report; 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211215006020/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Terminates Stock Purchase Agreement
DUBLIN, Ohio, December 15, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that it has terminated the Stock Purchase Agreement that was executed on August 30, 2020.
On August 30, 2020, the Company entered into a Stock Purchase Agreement with each of the investors named therein (the "Investors"), pursuant to which the Investors agreed to purchase from the Company up to $25.0 million in shares of the Company’s common stock, par value $0.001 per share ("Common Stock"). The initial closings of the sale and purchase of the Common Stock (collectively, the "Initial Closing") were to occur within forty-five (45) business days after the date on which the Company’s application to the NYSE American for the listing of the Common Shares for trading thereon was approved by the NYSE American. The Investors agreed to purchase an aggregate of 1,000,000 shares of Common Stock at the Initial Closing at a purchase price of $5.00 per share. To date, we have received only $25,000 of the $5.0 million that was due at the Initial Closing. On December 14, 2021, the Company notified the Investors that it was terminating the Stock Purchase Agreement in accordance with its terms.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 fact that the valuation by LifeSci Partners of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions about the commercial success of the product, expected associated costs, and the outcome of various risks, including the outcome of clinical trials, that could affect the timetable for revenues, among other assumptions, that actual outcomes are likely to vary from such assumptions, resulting in variations from the possible results set forth in the valuation report; 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211215006017/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Third-Party Asset Valuation of Tc99m Tilmanocept for Indications in Rheumatoid Arthritis
DUBLIN, Ohio, December 13, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the results of a third-party asset valuation of its Rheumatoid Arthritis ("RA") diagnostic product candidate.
The Company engaged the independent third-party valuation firm, LifeSci Partners (LifeSci Advisors, LLC), to perform a U.S.-focused market research valuation of its advanced pipeline product Tc99m tilmanocept for prediction of treatment efficacy of anti-TNFa therapy in RA. A summary of the valuation report and the assumptions on which it is based is available on the Company’s website, https://www.navidea.com.
The Company is advancing its program evaluating Tc99m tilmanocept imaging, a radiopharmaceutical that selectively targets the CD206 receptor expressed on activated macrophages, for indications in RA. A previously completed Phase 2B study demonstrated results in support of the hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA. The planned Phase 3 trial will evaluate the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNFa therapy.
The valuation report used cited research and assumptions believed to conform to industry best practices. Under base-case assumptions that are discussed in the report, peak U.S. sales could reach $1 billion annually, and in the upside scenario peak annual U.S. sales could reach $1.8 billion. Opportunities for added value include possible indication expansion to other classes of RA therapeutics, registration of Tc99m tilmanocept imaging as a biomarker of activated macrophages in the joints of patients with RA, and expansion into additional geographic areas.
Dr. Michael Rosol, Navidea’s Chief Medical Officer, said, "This report provides a third-party assessment of the potential commercial value of Tc99m tilmanocept in the U.S. market. We have released this in the spirit of transparency, while also giving investors a view into the company’s internal rigor in evaluating investments in the product pipeline." Dr. Rosol continued, "We believe we are on the right path to bringing a valuable tool to bear to meet a large unmet medical need in patients with RA. Success would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is possible today."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 fact that the valuation by LifeSci Partners of our Tc99m tilmanocept pipeline product is subject to and based on numerous assumptions about the commercial success of the product, expected associated costs, and the outcome of various risks, including the outcome of clinical trials, that could affect the timetable for revenues, among other assumptions, that actual outcomes are likely to vary from such assumptions, resulting in variations from the possible results set forth in the valuation report; 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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211213005233/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Business Update Call and Changes to Board of Directors Composition
Conference Call to be held Thursday, December 16, 2021 at 5:00 pm (EST)
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced a conference call to provide updates and discuss strategy, as well as the resignation of Thomas Farb and Agnieszka Winkler as members of the Company’s Board of Directors (the “Board”), effective December 5, 2021.
The Company will hold the conference call and webcast on Thursday, December 16, 2021 at 5:00 p.m. (EST). Chairman Alexander L. Cappello, Vice Chairman John K. Scott, Jr., and Chief Medical Officer Dr. Michael Rosol will host the call and webcast to provide an update on recent developments and clinical progress.
Michael Rosol, Navidea’s Chief Medical Officer, said, “The senior management of the Company, as well as the Board of Directors, are eager to hold this informational Q&A call with our shareholders to provide updates and outline strategy as we move forward.”
Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, “We look forward to the discussion on the 16th and getting to know our investors and addressing their interests and concerns. We also wish to thank both Thomas Farb and Agnieszka Winkler for their outstanding service on the Board and the valuable insights they have provided during this time of transition for the Company. Their contributions helped shape the direction of the Company as we move forward. We wish them the best in their future endeavors.”
To participate in the call and webcast, please refer to the information below:
Event: Navidea Biopharmaceuticals Business Update
Date: Thursday, December 16, 2021
Time: 5:00 p.m. (EST)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13725627
Webcast Link: https://webcast-eqs.com/navidbioph20211216/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 American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211209005986/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals to Host Third Quarter 2021 Earnings Conference Call and Business Update
Conference Call to be Held on Wednesday, November 10, 2021 at 5:00 p.m. (EST)
DUBLIN, Ohio, November 03, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Wednesday, November 10, 2021 at 5:00 p.m. (EST) to discuss financial results and corporate developments for the third quarter ended September 30, 2021.
Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress.
Questions will not be taken during the conference call, however you may submit questions up to 24 hours in advance of the meeting by sending an email to info@navidea.com. We ask that you limit your questions to those that are relevant to our business. Questions may not be addressed if they are, among other things, profane, irrelevant to our business, related to pending or threatened litigation, disorderly, or repetitious of statements already made. In addition, questions may be grouped by topic by our management with a representative question read aloud and answered. Questions will be addressed in the Q&A portion of the conference call, and we may also respond to questions on an individual basis or by posting answers on our website after the call.
To participate in the call and webcast, please refer to the information below:
Event: Third Quarter 2021 Earnings Conference Call and Business Update
Date: Wednesday, November 10, 2021
Time: 5:00 p.m. (EST)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13724382
Webcast Link: https://webcast-eqs.com/navidbioph20211110/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 American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211103006154/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jeff Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Resignation of Jed A. Latkin
DUBLIN, Ohio, October 26, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the resignation of Jed A. Latkin as Chief Executive Officer, Chief Financial Officer and Chief Operating Officer of the Company, and as a member of the Board of Directors of the Company, effective October 24, 2021. Mr. Latkin and the Company are discussing the terms of a severance agreement pursuant to his employment contract.
An Office of the CEO including three members of the Company’s Board of Directors has been established to lead the Company on an interim basis while the next Chief Executive Officer of the Company is identified with the assistance of an executive search firm. The Office of the CEO consists of three Board members, including the Chairman, Vice Chairman and Thomas Farb, and the Company’s Senior Vice President and Chief Medical Officer, Michael Rosol, Ph.D., and the Company’s Vice President of Finance and Administration, Erika Eves.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211026006301/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeff Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Appoints Thomas Forest Farb-Horch and Agnieszka Winkler to the Board of Directors
DUBLIN, Ohio, October 14, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Thomas Forest Farb-Horch and Agnieszka Winkler to its Board of Directors, effective October 7, 2021, each with a three-year term ending concurrently with the Company’s 2024 annual stockholders’ meeting.
Thomas Forest Farb-Horch has over three decades of experience as an investor in and senior executive of numerous life science and information technology companies both in the U.S. and internationally. Mr. Farb has served as the Chief Executive Officer, President, co-founder and director of Thrive Bioscience, Inc. since May 2014. He has also served as President, Chief Operating Officer and in other C-level positions at several other companies, including Interneuron Pharmaceuticals (NASDAQ), Indevus Pharmaceuticals (NASDAQ), and Cytyc (NASDAQ). Mr. Farb currently serves on the boards of directors of North Shore InnoVentures and AutoImmunity Biologic Solutions, and is a member of the scientific advisory board of Emervax. Mr. Farb previously served on the boards of directors of Fair Isaac (NYSE:FICO), Redwood Trust (NYSE:RWT), HNC Software (NASDAQ), Retek Systems (NASDAQ) and Symon Communications (NASDAQ). Mr. Farb earned a B.A. in sociology from Harvard University.
Agnieszka Winkler has extensive professional and board experience with start-up, mid-cap and Fortune 500 companies. Ms. Winkler currently serves on the board of directors of Virco (NASDAQ:VIRC) and the board of trustees of each of Santa Clara University and the African Diaspora Network. She also serves as Chair of the board of directors of the Jesuit School of Theology and as President of the board of Catholic Charities of Santa Clara County. Ms. Winkler has previously served on numerous public company boards such as SuperCuts (NASDAQ), Reno Air (NASDAQ), The Cheesecake Factory (NASDAQ:CAKE), and Inter-Tel (NASDAQ), as well as private company boards including Ascension, a $22B healthcare system, Ascension Network and IPLocks. She was the founder and former Chair and Chief Executive Officer of TeamToolz, a software company, and Winkler Advertising, both of which were acquired. Ms. Winkler earned a B.A. in history from Holy Names University, an M.A. in history from San Jose State University, and an M.B.A. from Santa Clara University.
Navidea Chief Executive Officer Jed Latkin said, "Navidea is pleased to add two highly respected and exceptionally talented individuals to its Board of Directors. Their combined experience will help guide the Company through its next phases of growth and development."
Navidea Chair of the Board Alexander L. Cappello said, "I am proud to join Jed Latkin in welcoming seasoned directors of such high caliber as Thomas Farb and Agnieszka Winkler to the Navidea Board of Directors. Their combined management experience as CEOs, operators, public company managers, all aspects of leadership and every possible committee brings a wealth of maturity, relationships and experience to Navidea."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211014005277/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Appoints Michel Mikhail, Ph.D. as Chief Regulatory Officer
DUBLIN, Ohio, September 27, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Michel Mikhail, Ph.D. as Chief Regulatory Officer of Navidea, effective October 1, 2021.
Dr. Mikhail has more than 30 years of experience in the pharmaceutical industry and a track record of achievement in R&D and international regulatory affairs at large multinational research-based pharmaceutical companies. Prior to joining Navidea, Dr. Mikhail worked in global regulatory consulting for various pharmaceutical and biotech companies from January 2016 through September 2021. Before acting as a consultant, Dr. Mikhail served in senior regulatory executive roles at BioNTech AG, Fresenius Kabi, Ranbaxy Europe Ltd. (now SunPharma), Pharmacia & Upjohn (now Pfizer), Knoll AG (now Abbvie), SmithKline Beecham (now GlaxoSmithKline), and Boehringer Ingelheim. Dr. Mikhail is a global expert in Regulatory Affairs dealing with the U.S. Food and Drug Administration ("US-FDA"), the European Medicines Agency ("EU-EMA") as well as national agencies in Europe, Japan’s Pharmaceuticals and Medical Devices Agency, China’s National Medical Products Administration, among other regulatory agencies worldwide. He is a Chartered Expert in Pharmacology-Toxicology. Dr Mikhail served on the Safety working group and Efficacy working group of the European Federation of Pharmaceutical Industry Associations and as a Topic Leader for new guidelines. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America, on the European Biosimilars Group, the Regulatory and Scientific Affairs Group of the European Generic medicines Association (now Medicines for Europe), as well as on different associations and organizations. Dr. Mikhail is a lifetime member of The Organization for Professionals in Regulatory Affairs, and has contributed as volunteer at the Drug Information Association and the Parenteral Drug Association. Dr. Mikhail was part of the Transatlantic Trade and Investment Partnership negotiations aiming at harmonization of regulatory requirements and relying on each other’s inspections between the EU-EMA and US-FDA. Dr. Mikhail served as a volunteer member of the Expert Committee of the Governmental Federal Institute of Risk Assessment in Berlin, Germany and served as a volunteer member of the Expert Committee for Toxicology of the United States Pharmacopoeia in Maryland, USA. Dr. Mikhail holds a Ph.D. from the University of Paris and a Ph.D. from the University of Hannover.
Dr. Mikhail said, "This is an exciting opportunity to join Navidea’s leadership team, to expand the product portfolio leveraging on the diagnostic imaging and the therapeutic Manocept platform. I look forward to working with the US-FDA, the EU-EMA and regulatory agencies around the world and with the Navidea development teams and partners to deliver on Navidea’s drug development initiatives, ensuring they are completed and approved on time and to the highest quality standards that can lead to positive patient impact. I am proud to join a world-class team to support Navidea’s anticipated growth, as we execute on our mission of helping patients have the right effective medicine from the start to treat their disease, minimizing exposure to unwanted side effects and saving cost for the payers."
Navidea Chief Executive Officer Jed Latkin said, "We are very pleased to welcome Dr. Michel Mikhail to our executive leadership team, as he brings over 30 years of expertise in the field of global regulatory affairs and drug development. He has experience in accompanying drug development through regulatory agency meetings and scientific advice, from start until successful completion of Phase 3 clinical trials as well as indication expansion and successful approval by regulatory authorities. We look forward to a successful development and implementation of regulatory strategy for development and expansion of our Manocept platform to enhance patient care and contribute to covering unmet medical needs for drug imaging technology and therapeutic use in rheumatoid arthritis and beyond."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210927005202/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Changes to Board of Directors Composition
DUBLIN, Ohio, September 17, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on September 14, 2021, at a meeting of the Board of Directors (the "Board") of the Company that followed the Company’s 2021 Annual Meeting of Stockholders, S. Kathryn Rouan, Ph.D. retired as Chair of the Board and as a director, and Claudine Bruck, Ph.D. retired as a director, both effective immediately.
Following the retirement of Dr. Rouan as Chair, the Board appointed Alexander L. Cappello and John K. Scott, Jr., who were both existing members of the Board, as Chair of the Board and Vice Chair of the Board, respectively.
Also effective September 14, 2021, the Board appointed Mr. Cappello to the Audit Committee, and therefore the current members of the Audit Committee are Amit Bhalla (Chair), Malcolm Witter and Mr. Cappello. On the same date, the Board appointed Messrs. Cappello and Scott to the Compensation, Nominating and Governance ("CNG") Committee and appointed Mr. Witter as Chair, and therefore, the current members of the CNG Committee are Mr. Witter (Chair), Mr. Scott and Mr. Cappello.
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Jed Latkin, Navidea’s CEO said, "We thank both Kathy and Claudine for their service on the Board and the valuable insights they have provided over the years. With a combined 60 years of experience in the clinical space their contributions helped shape both the diagnostic and therapeutic direction of the Company. We wish them the best in their future endeavors."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210917005043/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Reports Second Quarter 2021 Financial Results
Conference Call to be held Wednesday, August 11, 2021 at 5:00 pm EDT
DUBLIN, Ohio, August 11, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the second quarter and year-to-date for the period ended June 30, 2021.
"The Company is prepared and looking forward to our meeting with the U.S. Food and Drug Administration ("FDA") on September 1," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We remain laser focused on a positive meeting and a successful launch to the NAV3-33 trial. Navidea is also extremely excited to now have a full 7-member board with the appointments of Amit Bhalla, Alex Cappello and John K. Scott, Jr. to the board."
Second Quarter 2021 Highlights and Subsequent Events
NEWS -- Navidea Biopharmaceuticals to Host Second Quarter 2021 Earnings Conference Call and Business Update
Conference Call to be Held on Wednesday, August 11, 2021 at 5:00 p.m. (EDT)
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will host a conference call and webcast on Wednesday, August 11, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the second quarter ended June 30, 2021.
Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.
To participate in the call and webcast, please refer to the information below:
Event: Second Quarter 2021 Earnings Conference Call and Business Update
Date: Wednesday, August 11, 2021
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-in: 877-407-0312
International Dial-in: +1 201-389-0899
Conference ID: 13721827
Webcast Link: https://webcast-eqs.com/navidbioph20210811/en
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210804005152/en/
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces First 110 Subjects Imaged in NAV3-35 Normative Database Phase 2b Study to Support Rheumatoid Arthritis Indications
DUBLIN, Ohio, July 19, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that over 110 subjects have been enrolled and imaged in its NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept." Expected total enrollment for this two-arm trial will be 135 participants.
NAV3-35 will establish a database of hand and wrist images taken following Tc99m tilmanocept administration in healthy volunteers age- and sex-matched to the population of RA patients. Tc99m tilmanocept attaches to mannose receptors (CD206) on macrophages that are frequently involved in RA joint inflammation. Relatively smaller numbers of CD206 expressing macrophages normally reside in the joints of healthy people without RA. An integral part of the ability to quantitatively discriminate RA-inflamed joints from those that do not have inflammation using Tc99m tilmanocept imaging is the knowledge of the distribution of Tc99m tilmanocept localization in healthy joints. The establishment of this normal subject database (i.e., normative database) will enable improved accuracy of discrimination of RA-involved joints from non-RA inflamed joints and should have a positive impact on the ability to predict treatment response early. This database will also be used in the training of automated image analysis algorithms to further improve the accuracy of the quantification of Tc99m tilmanocept localization in joints as well as the workflow for later commercialization in RA.
The aim is to recruit 135 volunteers in this two-arm study. The first arm is comprised of 120 healthy subjects who will have planar imaging of their hands and wrists post administration of Tc99m tilmanocept, and arm two is a 15-subject arm comprised of 10 patients with RA and 5 healthy volunteers with the aim of demonstrating the feasibility of 3-dimensional SPECT/CT imaging for the quantitative assessment of RA-involved inflammation in joints. To date, over 100 subjects have been imaged for Arm 1, and 10 in Arm 2.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "The normative database, establishing the parameters of what a normal joint looks like with Tc99m tilmanocept, will play an essential part in both the Phase 3 data analysis as well as planned commercial product." Dr. Rosol continued, "These data will also be used to optimize automated image analysis to improve upon accuracy and streamline workflow for widespread adoption of Tc99m tilmanocept imaging in RA."
Jed Latkin, Chief Executive Officer and Chief Financial Officer for Navidea, said, "The rapid enrollment of this trial is truly a testament to Navidea’s focus on delivering quick results as we launch more trials to bring the Company ever closer to the launching of the RA Diagnostic product."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 https://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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210719005065/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces End-of-Phase 2 Type B Meeting Request Granted by the FDA to Discuss Ongoing Clinical Program in Rheumatoid Arthritis
DUBLIN, Ohio, July 15, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the U.S. Food and Drug Administration ("FDA") has granted the Company’s request for an End-of-Phase 2 Type B meeting to discuss its ongoing program in Rheumatoid Arthritis ("RA") and advancement to the pivotal Phase 3 trial. The meeting will take place on September 1, 2021, via conference call.
The meeting with the FDA will be centered on discussion of the results from the Company’s completed Phase 2b NAV3-31 study, "Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc99m Tilmanocept Planar Imaging" and the proposed protocol and analysis plans for the Phase 3 trial. Previously, the FDA reviewed the interim data and provided pertinent feedback on progressing the remaining patient data and encouraged an End-of-Phase 2 meeting when complete.
Navidea’s NAV3-31 trial had three arms: Arm 1 consisted of healthy subjects, Arm 2 was comprised of patients with active, moderate-to-severe RA who are on stable therapy, and Arm 3 was a pilot arm designed to assess the ability of Tc99m tilmanocept to provide an early indicator of efficacy of anti-tumor necrosis factor ("TNF") a treatment in RA patients. Previously reported interim analyses demonstrated results in support of Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active RA, and that this imaging can provide an early indicator of treatment efficacy in patients with active RA.
The pivotal Phase 3 trial will establish the ability of Tc99m tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNFa therapy. The design and planned conduct of the Phase 3 trial is built upon insights and data from the completed Phase 2b NAV3-31 trial.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are eager to discuss the results from our completed Phase 2b trial as well as the design of the planned Phase 3 trial with the FDA. Throughout our RA program development, we have worked closely with expert rheumatologists, nuclear medicine specialists, and the FDA itself, and we believe we are on the right path to bringing a valuable tool to bear to meet a large unmet medical need in patients with RA." Dr. Rosol continued, "Success would mean that we can provide rheumatologists and those suffering with RA a noninvasive, quantifiable, early indicator of whether or not an anti-TNFa treatment is working. This could bring enormous benefit to these patients by assisting physicians in putting them on the right course of treatment earlier than is possible today."
Jed Latkin, Chief Executive Officer and Chief Financial Officer for Navidea, said, "We are very excited to meet with the FDA and finally proceed with launching the Phase 3 trial for the approval of Navidea’s RA monitoring agent. The clinical and regulatory teams have been working non-stop to complete the review of a massive amount of data obtained from NAV3-31. I am extremely proud of the work they have accomplished to date and eagerly anticipate the next steps towards approval."
RA is a chronic disease affecting over 1.3 million Americans and as much as 1% of the worldwide population1. If the product is successfully developed, Navidea would expect to play a major role in the management of RA patients worldwide.
Reference
1. https://www.rheumatoidarthritis.org/ra/facts-and-statistics/
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210715005139/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Macrophage Therapeutics, Inc. Wins Delaware Case Against Michael Goldberg for Breach of Fiduciary Duty
DUBLIN, Ohio, June 24, 2021--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that on June 23, 2021, Vice Chancellor Joseph Slights of the Court of Chancery of the State of Delaware (the "Court") ruled in favor of Navidea’s wholly-owned subsidiary, Macrophage Therapeutics, Inc. ("MT") and against its former CEO, Dr. Michael Goldberg, finding that Dr. Goldberg breached his fiduciary duties to MT.
This decision follows an earlier June 12, 2019 ruling in which the Court voided certain transactions putatively authorized by Dr. Goldberg, pursuant to which Dr. Goldberg purported to transfer certain of Navidea’s intellectual property rights (which had been sub-licensed to MT) to a company controlled by Dr. Goldberg, but had previously ruled that there remained factual questions as to whether Dr. Goldberg’s conduct constituted a breach of fiduciary duty to MT.
Following a three-day trial and extensive post-trial briefing, the Court agreed with MT that Dr. Goldberg breached his fiduciary duty. Specifically, the Court ruled: "Dr. Goldberg attempted to take for himself that which belonged to [MT]. In doing so, he breached his duty of loyalty to [MT] stockholders. [MT] was absolutely justified in bringing this action to remedy (in this case undo) the harm caused by Dr. Goldberg’s misconduct." The Court disagreed with MT’s arguments regarding damages and, other than awarding nominal damages, declined to award additional relief beyond that which it had previously granted. With respect to MT’s claim for conversion, the Court found that the claim was not supported because "Dr. Goldberg confirmed that he currently does not own or possess any intellectual property related to either Navidea or [MT]" and that "any IP Dr. Goldberg created while at Navidea or any of its subsidiaries was and remains the property of Navidea and its subsidiaries."
In addition, the Court denied Dr. Goldberg’s motion to hold MT’s directors and CEO in contempt, denied Dr. Goldberg’s motion to dismiss the lawsuit against him, and granted MT’s motion to dismiss Dr. Goldberg’s petition to remove MT’s board members.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210624005237/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Issuance of U.S. Patent for Diagnosis and Treatment of Viral Infections
Business Wire -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the U.S. Patent and Trademark Office (“USPTO”) issued to Navidea U.S. patent 11,007,272, entitled “Compounds and Methods for Diagnosis and Treatment of Viral Infections,” with protection to October 7, 2037.
This patent protects the use of Navidea’s mannosylated dextran-based drug delivery vehicles to deliver small molecule therapeutic payloads as possible therapies for a variety of diseases caused by a group of viruses known as flaviviruses. Specific flaviviruses disclosed in the patent include those that cause dengue, yellow fever, and Zika fever. Dengue is a common serious illness in many tropical countries, with an estimated 100-400 million infections per year according to the World Health Organization.
In humans, these flaviviruses replicate extensively, and sometimes nearly exclusively, in CD206+ macrophages. CD206+ macrophages are the primary intended targets of Navidea’s mannosylated dextran-based drug delivery vehicles, making them capable of delivering potent drugs to the cells where the virus is multiplying.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “Our targeted therapeutics have the potential to address the large unmet medical need caused by flaviviruses given deficiencies in current therapies and/or vaccines.” Dr. Rosol continued, “The technology covered in this patent could also have implications for possible treatments of other infectious diseases where our platform might have an impact, including HIV and hepatitis C.”
Jed Latkin, Chief Executive Officer for Navidea, said, “I am proud of the work that our chemists have been doing and we continue to move the ball forward and perfect the intellectual property to protect our portfolio for the future.“
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210519005204/en/
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Reports First Quarter 2021 Financial Results
Conference Call to be held Tuesday, May 11, 2021 at 5:00 pm EDT
May 11, 2021 04:01 PM Eastern Daylight Time
DUBLIN, Ohio -- (BUSINESS WIRE) -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced its financial results for the first quarter for the period ended March 31, 2021.
“We are continuing a positive dialogue with the FDA and are moving as quickly as we can to fully document all the data from Arm 3 of NAV3-31,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “We are also excited to begin patient enrollment for NAV3-32 both here in the U.S. and in the UK.”
First Quarter 2021 Highlights and Subsequent Events
NEWS -- Navidea Biopharmaceuticals, Inc. to Host Earnings Call
NEW YORK, NY / ACCESSWIRE / May 11, 2021 / Navidea Biopharmaceuticals, Inc. (NYSE:NAVB) will be discussing their earnings results in their 2021 First Quarter Earnings call to be held on May 11, 2021 at 5:00 PM Eastern Time.
To listen to the event live or access a replay of the call - visit
https://www.investornetwork.com/event/presentation/78941
To receive updates for this company you can register by emailing mailto://info@investornetwork.com or by clicking get investment info from the company's profile.
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View source version on accesswire.com:
https://www.accesswire.com/646219/Navidea-Biopharmaceuticals-Inc-to-Host-Earnings-Call
NEWS -- Navidea Biopharmaceuticals Announces NIH Grant Award to UC San Diego for Clinical Study Evaluating Tc99m Tilmanocept as a Kidney Imaging Agent
Business Wire -- Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the granting of a National Institutes of Health (“NIH”) award to the University of California San Diego School of Medicine for the proposal entitled, “Renal Molecular Imaging of Mesangial Cell Function with Tc-99m-Tilmanocept.” The award (Project Number: 1R01DK127201-01), from the National Institute of Diabetes and Digestive and Kidney Diseases of the NIH, was granted to Co-Principal Investigators UC San Diego faculty Carl Hoh, MD and David Vera, PhD, of the Department of Radiology, and Charles Ginsberg, MD, MAS, of the Department of Medicine, Division of Nephrology.
The worldwide prevalence of diabetes is expected to increase to 642 million within two decades. Approximately 40% of people with diabetes will go on to develop diabetic nephropathy (“DN”) – a form of chronic kidney disease (“CKD”). Typically, diabetic nephropathy develops relatively slowly over the course of decades, as indicated by slow increases in certain serum and urine markers over time. The current standard-of-care for monitoring the development of CKD is periodic assessment of these aforementioned markers. However, twenty percent of diabetic patients who develop CKD experience a more rapid development of DN. Consequently, there is an unmet medical need for routine surveillance during the first decade of CKD.
In this Phase 1 clinical study being conducted at UC San Diego Health, Tc99m tilmanocept will be used as an imaging agent to evaluate a key component of the kidneys, the mesangial cells, as a biomarker for diabetic nephropathy. The molecular target for Tc99m tilmanocept, CD206, is expressed on these mesangial cells of the kidney. The expansion of mesangial cells is an early hallmark of diabetic nephropathy, and the ability to reliably image them noninvasively could provide an important tool for physicians to evaluate diabetic patients for early signs of the disease.
This trial will be an open-label study investigating the biodistribution at two dose levels (2.0 and 20 nmol) of Tc99m tilmanocept. Four groups of patients at each dose (10 subjects each), will be studied: 1) No CKD, 2) early CKD, 3) moderate CKD, and 4) advanced CKD. Within each group, 50% of participants will have diabetes. Expected results include kidney image sets and biodistribution of Tc99m tilmanocept that reflects pathology. This study is a necessary step toward FDA approval of Tc99m tilmanocept as a kidney imaging agent.
From the proposal’s Public Health Relevance Statement: “This proposal will use kidney SPECT/CT of Tc-99m-tilmanocept to evaluate the mesangial changes seen in diabetics across the spectrum of kidney disease as well as persons with hypertensive kidney disease, the next most common cause of kidney disease in patients with diabetes. We aim to demonstrate that these different disease types and stages can be differentiated with Tc-99m-tilmanocept SPECT/CT and can thus be used for future trials evaluating early diagnosis and treatment of diabetic nephropathy.”
Dr. David Vera, Co-Principal Investigator, said, “Our goal is a simple ‘first-line’ diagnostic tool for nephrologists to determine which of their patients with diabetes are at risk of chronic kidney disease.” Dr. Hoh added, “an additional potential benefit to a Tc-99m-tilmanocept kidney imaging study may be an additional modality for screening of renal cancer.” Dr. Ginsberg stated, “considering the increasing armament of drugs to combat diabetic nephropathy, an imaging study that can diagnose this disease early in its course has tremendous therapeutic implications.”
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are pleased that the NIH has funded this important Phase 1 study at UC San Diego, run in part by the inventor of tilmanocept, Dr. David Vera.” Dr. Rosol continued, “Navidea has had a long and productive relationship with Dr. Vera and his collaborators at UC San Diego, and we will be keenly watching for the results of this study addressing this area of large unmet clinical need. Today’s announcement exemplifies the broad reach of our tilmanocept platform. The development pipeline remains robust and we are excited to continue developing new and valuable applications for our core technology.”
Dr. Vera, together with Drs Anne Wallace and Carl Hoh, developed Tc99m tilmanocept at UC San Diego Moores Cancer Center as an agent to help detect and map cancers that have reached the lymph nodes. Cancer clinical trials showed that it better detected cancer and provided more accurate staging.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210511005201/en/
Contacts:
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces Changes to Board of Directors Composition
Industry veteran Amit Bhalla appointed to the Board of Directors
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that Michael Rice, the Company’s Chair of the Board, and Adam Cutler have retired from their positions on Navidea’s Board of Directors to focus on other endeavors. Dr. Kathy Rouan has been appointed as Chair of the Board following Mr. Rice’s retirement.
Additionally, Amit Bhalla has been appointed to Navidea’s Board of Directors. Mr. Bhalla currently serves as the Chief Financial Officer of Infinity BiologiX. Prior to his current role he served as a Senior Healthcare Analyst at Lord, Abbett & Co. LLC and has held senior leadership positions at multiple Financial and Healthcare firms including Beckton Dickinson, Johnson & Johnson, Citigroup, and Morgan Stanley. Mr. Bhalla received his MBA from the Tepper School of Business and his undergraduate degree at Cornell University.
Jed Latkin, Navidea’s CEO said, "We thank both Michael and Adam for their service on the Board and the valuable insights they have provided over the years. We are excited about the addition of Amit Bhalla to the Board. His diverse background in financial services and operational roles at world class healthcare corporations will provide unique perspectives."
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: 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 https://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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210505005587/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jed Latkin
Chief Executive Officer
614-973-7490
mailto://jlatkin@navidea.com
Joel Kaufman
Chief Business Officer
614-822-2372
mailto://jkaufman@navidea.com
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