Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
NEWS -- Navidea Biopharmaceuticals, Inc. Announces Results of Exploratory Analysis Completed on July 2, 2024
Navidea Biopharmaceuticals, Inc. has completed an exploratory analysis of its Rheumatoid Arthritis Program
COLUMBUS, Ohio, July 03, 2024--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (OTC: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced disappointing results of an exploratory analysis conducted on the Company’s pivotal NAV3-33 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)" (ClinicalTrials.gov Identifier: NCT05246280) the "RA Trial."
The purpose of the exploratory analysis was to optimize the diagnostic performance in support of the methodologies to be applied in the final pivotal trial. The results confirm that intravenous Tc 99m tilmanocept can target and produce reliable images of macrophage activity in RA patients, but that these images do not adequately predict which patients will respond to treatment with an anti-TNF alpha medication.
"We were very surprised and disappointed that the results of the exploratory analysis did not support the hypothesis of an overall accuracy of early treatment response approaching 90%, but rather, the overall accuracy of early treatment response was on average consistently below 70%," said Dr. Michael Blue, Navidea’s Chief Medical Officer. "Results with that predictive value are not indicative of a commercially viable product."
Given these results, Navidea is suspending all activities related to the RA Trial. The Company is pivoting to focus on exploring all opportunities related to the Company’s therapeutic assets.
About Navidea
Navidea Biopharmaceuticals, Inc. (OTC: 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, 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/20240703199069/en/
Contacts
Investor Relations
Navidea Biopharmaceuticals, Inc.
Craig A. Dais, Chief Financial Officer
mailto://cdais@navidea.com
(614)-822-2322
NEWS -- Navidea Biopharmaceuticals, Inc. announces special meeting of stockholders to be held July 8, 2024
Navidea Biopharmaceucitals, Inc. will present two proposals for vote in a virtual special meeting of shareholders to be held on July 8, 2024
COLUMBUS, Ohio, June 20, 2024--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (OTC: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will be hosting a virtual meeting of its stockholders at 1pm ET on Monday, July 8th, 2024.
The purpose of the special meeting is to consider and vote upon (i) an amendment to the Company’s certificate of incorporation to allow stockholders to act by written consent, and (ii) an amendment to the Company’s certificate of incorporation to implement a reverse stock split of the Company’s common stock at a ratio of up to 1-for-50,000 shares. The decision of whether to complete a reverse stock split and the ratio at which it would be completed will be determined at the discretion of the Company’s Board of Directors.
"As we continue to pursue strategic partnerships or other opportunities to fund the Company’s ongoing clinical trial activities in Rheumatoid Arthritis, the option of a written consent will allow the Company to act in a timely manner," said Craig A. Dais, Navidea’s Chief Financial Officer. "In addition, as a measure to reduce costs and extend our cash runway, we want ensure the number of record holders of the Company’s common stock is below the SEC threshold, to avoid public reporting requirements." The reverse stock split, if implemented, would result in lowering the number of record holders.
Changes to the Board of Directors
Board of Directors, Dana J. Moss, Jill Bieker Stefanelli, and Joshua Wilson resigned their positions on the Company’s board of directors effective May 7, 2024. Related to this change, Navidea and G2G Ventures, LLC ("G2G Ventures"), for whom Mr. Wilson is the Executive Director, terminated G2G Venture’s Executive Consulting agreement with the Company.
"We are extremely grateful for the contributions of these three directors over the last several months," John K. Scott, Jr, Navidea’s Vice Chair of the Board. "We are also fortunate to have had the executive leadership of Dr. Jason Myers and his team at G2G Ventures for the last year. Going forward, we feel we are well positioned with our remaining management team, a total of eight employees, to continue to move the Company forward."
About Navidea
Navidea Biopharmaceuticals, Inc. (OTC: 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, 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/20230413005842/en/
View source version on businesswire.com: https://www.businesswire.com/news/home/20240620380826/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Craig A. Dais, Chief Financial Officer
mailto://cdais@navidea.com
(614)-822-2322
NEWS -- Navidea Biopharmaceuticals, Inc. and Capital Royalty Partners II, L.P. Enter Binding Settlement Agreement and Mutual Release
Navidea Biopharmaceuticals, Inc. and Capital Royalty Partners II, L.P. have entered into a binding settlement agreement and mutual release settling ongoing litigation.
DUBLIN, Ohio, December 01, 2023--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (OTC: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the Company and Capital Royalty Partners II, L.P. and other related entities (collectively, "CRG") have entered into a binding settlement agreement and mutual release settling all ongoing litigation between the parties.
CRG Settlement Agreement and Mutual Release Aligns with Company’s Approach
Navidea and CRG have been engaged in ongoing litigation since 2016. On August 30, 2022, a judgment was entered against Navidea, plus post-judgment interest, and Navidea appealed. As of September 30, 2023, the contingent liability for the judgment and accrued interest was $2,711,806.
The binding settlement agreement and mutual release resolves the judgment and settles all litigation between Navidea and CRG, including the pending appeal. This settlement agreement and mutual release also positions the Company to continue driving the organization forward and advance its innovative technology to market, following the Navidea’s Fix, Fund, Propel approach.
To provide the funding necessary for the CRG settlement, Navidea entered into a Loan and Securities Exchange agreement ("Loan Agreement") pursuant to which John K. Scott, Jr., Vice Chair of the Company’s Board of Directors, loaned the Company $750,000 with a maturity date of April 10, 2025. As a part of the Loan Agreement, Mr. Scott also agreed to restructure an existing note, including the forgiveness of $100,000 in principal and the transfer of Series G Preferred Stock and Series I Preferred Stock shares in exchange for newly-issued shares of Series J Preferred Stock of the Company. In addition, Mr. Scott has agreed to release the Company of its obligation to pay all accrued cash directors’ fees owing to Mr. Scott.
"We are pleased with the result and timing of this settlement," said Craig A. Dais, Navidea’s Chief Financial Officer. "In addition to immediately relieving the Company of a substantial financial burden, the settlement removes a significant and previously ongoing legal cost and management burden related to litigation, improves the balance sheet, and clears a substantial impediment to future strategic transactions and partnerships. We are also pleased that our Vice Chairman and principal stockholder, Mr. Scott, has stepped forward in a material way to make this settlement possible. By providing additional funding, and agreeing to restructure his existing equity holdings, we were able to simplify the Company’s equity structure, which creates opportunities for future financings and provides additional flexibility to help preserve the Company’s substantial NOLs. We are appreciative of Mr. Scott’s continued support of our overall strategy, and we see this as another tangible example of the growing momentum of our Fix, Fund, Propel approach."
About Navidea
Navidea Biopharmaceuticals, Inc. (OTC: 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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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 the Company’s progress, strategic options, business goals, 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; whether an over-the-counter trading market for our common stock will develop or persist; our ability to comply with any requirements for listing of our common stock on any stock exchange in the future; 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/20231201731149/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
just wait think this will blow up sooner then later
The amount of trash listed as a public company is sad
Hate being right
Scary
Sold that trash weeks with a $0.02 loss on its little pop, so you are wrong once again.
YOU BOUGHT THIS TRASH AND YOU TRYING TO NAVIGATE THE MARKET, YOU DO KNOW A R/S IN NEXT...LMOA...OH BOY, AMERICANS ARE LOST!
Delisted to total trash, over paid 300k +a year toxic trash CEO, and all that work there,who has not done one thing to deserve it, arecfully responsible for downward death spiral with probably no recovery insight, all in toxic greed to fund their way over the top salaries,with the SEC conducting an investigation,hopefully they end up in a lockup someplace and charge with fraud.
NEWS -- Navidea Biopharmaceuticals, Inc. Announces NYSE American’s Decision to Suspend Trading In Its Common Stock
The Company announced today that the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the NYSE American LLC upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the Company’s common stock. The company maintains strategic focus on its Fix, Fund, Propel approach.
DUBLIN, Ohio, October 06, 2023--(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 Listings Qualifications Panel (the "Panel") of the Committee for Review of the Board of Directors of the NYSE American LLC (the "Committee") upheld the NYSE Regulation staff’s previously announced determination to initiate delisting proceedings with respect to the Company’s common stock. Accordingly, the staff of NYSE Regulation has suspended trading in the common stock of Navidea from the NYSE American. The Company anticipates that its common stock will begin trading on the over-the-counter (OTC) markets.
The Company has a right to request a review of the Panel’s decision to delist the common stock by the Committee by making a written request within 15 calendar days of the date of the Panel’s decision. The filing of an application with the Securities and Exchange Commission to delist the common stock is pending completion of all applicable procedures, including any appeal by the Company of the Panel’s decision. The Company is in the process of determining whether to request a review of the Panel’s decision.
In the event the Company’s common stock is delisted, the Company will continue to be a Securities and Exchange Commission ("SEC") reporting company. The Company may then also consider relisting its common stock on a national securities exchange in the future if the Company determines that doing so is in the best interest of the Company and its stockholders. The Panel’s decision does not affect Navidea’s business operations.
"We are respectful of the process and the perspective of the Exchange’s staff and Listings Qualifications Panel," said Craig A. Dais, Navidea’s Chief Financial Officer. "We also believe in the progress the Company continues to make, and the impact of the changes being made to move the Company forward. We will maintain our focus on exploring all strategic options which advance us toward the Company’s objectives, including continuing active discussions focused on licensing partnerships and other non-dilutive capital raise options, in order to meet the Company’s business goals and deliver value to our stockholders."
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, visit https://www.navidea.com.
About G2G Ventures
G2G Ventures is a Colorado-based private equity firm focused on empowering organizations to reach their full potential through investment and consulting services. Specializing in creating long-term partnerships with trusted investors and established businesses, G2G Ventures draws on strong internal balance sheet liquidity, augmented by trusted investor capital, to craft bespoke capital solutions which include private equity investment, venture capital participation, and mezzanine debt options. Beyond financial investment, G2G Ventures provides accretive consulting services to help clarify strategic goals and key performance indicators (KPIs), evolve financial processes, and enhance operational effectiveness. To learn more about how G2G Ventures is a growth partner for enduring business, connect with our team.
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 the Company’s progress, strategic options, business goals, 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 common stock is subject to delisting from the NYSE American under a currently pending delisting proceeding; 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/20231005935545/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NAVB delisted from the NYSE AMEX to the OTC:
https://otce.finra.org/otce/dailyList?viewType=Additions
Yep, I just remembered that T1's are usually pending release of news, hopefully it's something positive,but with these guys that's asking for a lot.
I’ll guess delisting
Hope I am wrong for longs
Pending news
Question is good or bad
Beats me
Wonder why it's been halted
you never get news with deadline
maybe next week ..think it takes 10 days before they hear something
NAVB Delisting???
NAVB Delisting???
its a dilution pos
There has been a large amount of buyers grabbing large amounts of shares this premarket,just like yesterday, the dumbasses stacking on the offer over $0.11, have to be brain dead.
Dip shtt brainless offer stackers are so clueless, shortes at high risk of getting squeezed
Yeah does a little :)
Welcome!!!!
Thank you, DK11 :)