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NEWS -- Navidea Biopharmaceuticals, Inc. NAVB Requests Oral Hearing With NYSE Hearing Panel
Following the Company’s Fix, Fund, Propel approach, Navidea formally submitted a request for an oral hearing with New York Stock Exchange American (NYSE American) Hearing Panel to appeal potential delisting of its stock from the NYSE American.
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 has formally submitted a request for an oral hearing with NYSE American Hearing Panel to appeal potential delisting of its stock from the New York Stock Exchange (NYSE American), while also continuing its Fix, Fund, Propel approach.
“We are taking the prudent steps required to make our case to the Exchange Hearing Panel,” said Craig A. Dais, Navidea’s Chief Financial Officer. “We certainly respect the process and the perspective of the Exchange. We also believe strongly in the progress the Company is making, and the impact of the changes being made to move the Company forward. We look forward to the opportunity for a hearing, in order to provide detail on our strategic plans to fully remedy the required compliance actions which allow the Company to continue trading on the NYSE American. At the same time, we will continue our focus on using our Fix, Fund, Propel approach to advance Navidea’s innovative technology to market, follow our strategy, and deliver value to our stockholders.”
NYSE American Delisting Appeal Details
With the support of the Company’s Board, together with G2G Ventures as executive consultants, Navidea is taking steps toward its intent to appeal the potential delisting from NYSE American.
NEWS -- Navidea Biopharmaceuticals, Inc. Announces NYSE American Has Commenced Delisting Proceedings and Intent to Appeal NYSE American Determination
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, received written notification from NYSE American LLC ("NYSE American" or the "Exchange") stating that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of Navidea Biopharmaceuticals, Inc. (the “Company”) — ticker symbol NAVB —from the Exchange. The Company's Board of Directors has determined to appeal the Exchange's determination to commence delisting proceedings.
NYSE Regulation has determined that the Company is no longer suitable for listing pursuant to Section 1009(a) of the NYSE American Company Guide (the “Company Guide”) as the Company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii) and (iii) of the Company Guide by the end of the maximum 18-month compliance plan period, which expired on July 28, 2023. The Exchange’s application with the Securities and Exchange Commission to delist the Company’s common stock is pending, subject to completion of all applicable procedures, including any appeal by the Company of the NYSE Regulation staff’s decision.
The Company has a right to an appeal of the staff’s determination by the Exchange, provided that the Company files a written request for such review within seven calendar days after receiving the notice. The Company's Board of Directors has determined to appeal the Exchange's determination to commence delisting proceedings. There can be no assurance that Navidea’s request for continued listing will be granted.
The Company’s common stock will continue to be listed and traded on NYSE American during the pendency of the Company’s appeal, subject to NYSE American’s discretion to immediately suspend trading if it believes suspension to be in the public interest, for the protection of investors, or to promote just and equitable principles of trade.
Navidea intends to make arrangements to have its common stock quoted in the over-the-counter market if its common stock is delisted from the Exchange.
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 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 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/20230728368165/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Hires Craig A. Dais, CPA as Chief Financial Officer
Following the Company’s Fix, Fund, Propel approach, Mr. Dais’s hire strengthens financial expertise, leadership, and oversight, along with continuing Navidea’s focus on advancing innovative technology to market
DUBLIN, Ohio, July 27, 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 the hiring of Craig A. Dais, CPA in the position of Chief Financial Officer (CFO), reporting directly to the Company’s Chief Medical Officer. Mr. Dais’s hiring aligns with the Company’s stated objectives and its Fix, Fund, Propel approach to advancing innovative technology to market.
Financial Expertise, Leadership, and Oversight
Craig A. Dais’s hiring in the role of CFO, strengthens the Company’s financial expertise and oversight, supported by G2G Ventures as Executive Consultants, with demonstrated expertise in accounting, financial modeling, capital development, and strong growth-oriented leadership within private and publicly-held organizations. In his role, he is responsible for overseeing all aspects of Navidea’s financial success, including the preparation of all financial statements, reporting and analysis, the active management of the Company’s cash flows, and the development of expert teams responsible for managing and tracking financial activities.
"Craig is an active and experienced accounting and finance leader with the ability to see both the details and the big picture," said Michael Blue, M.D., FACEP, Navidea’s Chief Medical Officer. "He is a self-motivated leader with expertise in developing strong teams that can help the Company grow by providing insights, reporting, and financial acumen. His financial leadership will help bring Navidea's technology and assets to the forefront."
Mr. Dais continues an impactful career as financial executive, leader, and Certified Public Accountant, having served in various roles of increasing responsibility over 30 years. His recent experience includes serving as Chief Financial Officer at Colorado Pain Care, LLC, (Fractional) Chief Financial Officer at Ascent CFO Solutions, Chief Financial Officer at Duffy Crane & Hauling, Vice President of Finance at Pendum LLC and other leadership positions with public and private organizations. Craig began his career in finance with KPMG Peat Marwick. Mr. Dais earned a Bachelor of Science in Accounting, along with a Minor in Business, from Metropolitan State University of Denver, and is (inactive status) a Certified Public Accountant.
"I am thrilled to have the opportunity to join Navidea’s team as Chief Financial Officer, and eager to get started," said Mr. Dais. "I believe my experience and career has led me to this role, and I believe Navidea’s transformative technology can improve lives around the world. My goal is to get to work using my experience to make that happen."
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 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/20230727546541/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Welcomes Dana J Moss, JD to Board of Directors; Amit Bhalla Steps Down
In line with the Company’s Fix, Fund, Propel approach, Dana J Moss, JD joins Navidea’s Board, adding depth in legal advice, strategic business, life sciences and technology in support of stated strategy to advance innovative technology to market. Separately, Amit Bhalla steps down from Board.
DUBLIN, Ohio, July 13, 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 Dana J Moss, JD has joined the Company’s Board of Directors, adding depth in legal advice, strategic business, life sciences and technology in line with Navidea’s stated objectives and its Fix, Fund, Propel approach to advancing innovative technology to market. Separately, Amit Bhalla has stepped down from the Company’s Board.
Experienced Legal Professional, Focused Life Sciences and Technology Expertise
Dana J Moss, JD joins Navidea’s Board of Directors with demonstrated leadership and legal expertise within innovative organizations focused on life sciences and technology driven products. Moss’s career and expertise within both private and public entities bolsters the Board’s ability to guide business strategy, mitigate risks and deliver stockholder value.
"Dana Moss’s addition allows Navidea to level-up expertise in several important areas within the Board," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "She is a demonstrated expert and professional in the truest sense, with a career that includes strategy, finance, mergers and acquisitions, governance, litigation, and risk mitigation. Dana understands where we are and where we are heading, and has the skills and experience to guide Navidea’s technology and assets to the forefront."
Dana J Moss previously served as the Chief Legal Officer and Corporate Secretary at Sequencing Health, Inc., where she was responsible for all legal, regulatory, compliance, and intellectual property matters, led strategy related to fundraising, mergers and acquisitions, and oversaw finance, corporate governance and human resources functions. Her previous experience includes serving as General Counsel, Corporate Secretary at Genapsys, Inc., as a Partner at Cooley LLP with a focus on Commercial Litigation, Program Manager at Mantech International Corporation, and as a Special Agent and Operations Officer of the U.S. Air Force Office of Special Investigations. Ms. Moss earned a Bachelor of Science at the United Air Force Academy, where she was a distinguished graduate, a Master of Arts in Philosophy at the University of Texas at Austin as a USAFA Graduate School Scholarship recipient, and a Juris Doctorate at the University of Maryland Francis King Carey School of Law, where she graduated cum laude. Dana is a 2021 Fellow of the Leadership Council on Legal Diversity and has served on the organizing Board of MissionLink, a nonprofit membership organization for C-level executives of high growth technology companies.
Separately, Amit Bhalla has decided to step down from the Board to focus on other business interests.
"We thank Amit Bhalla for his many contributions during his time with the Board," said John K. Scott, Jr, Navidea’s Vice Chair of the Board. "Amit’s strategic guidance and expertise within the emerging medical technology space have helped us press our business forward, and we wish him the very best as we continue developing processes and growth strategies led by Navidea’s team of experts and our experienced partners in G2G Ventures."
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 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/20230713154771/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Rejects Unsolicited Offer To Acquire Certain Assets
Following the Company’s Fix, Fund, Propel approach, the proposal substantially undervalues Navidea and is not in the best interests of stockholders.
DUBLIN, Ohio, June 30, 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 the Company’s Board of Directors, in consultation with G2G Ventures as Executive Consultants, has unanimously rejected an unsolicited, non-binding offer from ProPhase Labs to acquire certain assets from the Company on the terms disclosed in their press release on June 29, 2023.
"After careful review and consideration of ProPhase Labs’ unsolicited proposal, our Board determined that the proposal substantially undervalues Navidea’s assets, is opportunistic, and is not in the best interest of our stockholders," said Josh Wilson, Navidea’s Director. "While we certainly understand and are appreciative of the interest in Navidea’s unique technologies, the Board is confident that the Company’s stated objectives and its Fix, Fund, Propel approach to advancing our innovations to market will generate far superior long-term value for stockholders."
The Company, with G2G Ventures as Executive Consultants, recently announced the receipt of $7.5 million cash from Cardinal Health in lieu of a contingent milestone payment, and provided additional insight on its recent performance in line with its Fix, Fund, Propel approach.
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 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; 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/20230630207937/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Announces Distribution of Series K Preferred Stock to Holders of its Common Stock
DUBLIN, Ohio, June 16, 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 its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series K Preferred Stock, par value $0.001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on June 27, 2023. The shares of Series K Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on June 27, 2023. The outstanding shares of Series K Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series K Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series K Preferred Stock).
All shares of Series K Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series K Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.
The Series K Preferred Stock will be uncertificated, and no shares of Series K Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series K Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.
Further details regarding the Series K Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.
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.
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/20230616215293/en/
Contacts
Navidea Biopharmaceuticals, Inc.
G2G Ventures – Executive Consultant
Theodore Gerbick
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Receives $7.5 Million Cash from Cardinal Health in Lieu of Contingent Milestone Payment
Continuing the Company’s Fix, Fund, Propel approach, the cash payment from Cardinal Health aligns strategic goals while solidifying immediate capital for funding Phase IIb and Phase III trials.
DUBLIN, Ohio, June 16, 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 on June 14, 2023 it entered into an amendment (the "Amendment") to the Asset Purchase Agreement, dated November 23, 2016 (the "Purchase Agreement"), between the Company and Cardinal Health 414, LLC ("Cardinal Health 414"), an affiliate of Cardinal Health, Inc. (NYSE: CAH). Under the terms of the Amendment, Cardinal Health 414 paid the Company $7.5 million in cash on June 14, 2023 and the Company waived its right to receive any contingent Milestone Payment that might otherwise become due and payable under the Purchase Agreement. The cash payment from Cardinal Health 414 provides immediate capital for the Company’s Phase IIb (NAV3-32) and Phase III (NAV3-33) trials and related operations. Building on a history of partnership between the Company and Cardinal Health, the Amendment also aligns and supports growth goals related to LYMPHOSEEK® for both organizations.
Prior to entering into the Amendment with Cardinal Health 414, the Company and Keystone Capital Partners ("Keystone") agreed to terminate the letter of intent between them which outlined the material terms of the Company’s proposed sale of the Milestone Payment to Keystone for $8 million. Supported by G2G Ventures as Executive Consultants, the Company determined that the Amendment with Cardinal Health 414 provided greater certainty of closing and accelerated funding without the inclusion of dilutive warrants. Keystone remains a trusted partner of the Company and is expected to continue to assist the Company in its future financing efforts. The powerful combination of accelerated funding, strategic partnership and continued capital access allows the Company to expand its clinical trial base while delivering shareholder value.
"The amendment with Cardinal Health and equity line from Keystone Partners offers immediate capital and continuing positive support for Navidea’s pioneering work," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "This is a great example of how a focused approach can drive the business forward, surface opportunities, strengthen relationships, and create shareholder return."
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 Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With more than 50 years in business, operations in more than 30 countries and approximately 46,500 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at https://cardinalhealth.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 their 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 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/20230616130485/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures- Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Receives NYSE American Notice
DUBLIN, Ohio, June 02, 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 it received a Notice (the "Notice") on June 1, 2023 from the NYSE American LLC (the "NYSE American") stating that the Company is not in compliance with the continued listing standards as set forth in Section 1003(f)(v) of the NYSE American Company Guide ("Company Guide").
The Notice stated that because the Company’s common stock had been trading for a low price per share for a substantial period of time, the Company was not in compliance with Section 1003(f)(v) of the Company Guide. The NYSE American staff determined that the Company’s continued listing is predicated on it demonstrating sustained price improvement within a reasonable period of time or effecting a reverse stock split of its common stock, which the staff determined to be until December 1, 2023, and could be extended to the Company’s next annual meeting of shareholders to be held in 2023. The Company intends to regain compliance with the NYSE American’s continued listing standards by undertaking a measure or measures that are considered necessary and in the best interests of the Company and its shareholders.
The Notice has no immediate effect on the listing or trading of the Company’s common stock and the common stock will continue to trade on the NYSE American under the symbol "NAVB". The Company remains subject to the conditions set forth in the NYSE American’s letters dated January 28, 2022 and April 8, 2022 for stockholders’ equity noncompliance. The Company will continue to be included in the list of NYSE American noncompliant issuers and the below compliance (".BC") indicator will continue to be disseminated with the Company’s ticker symbol(s). The website posting and .BC indicator will be removed when the Company has regained compliance with all applicable continued listing standards. Additionally, the Notice does not result in the immediate delisting of the Company’s stock from the NYSE American. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. The Company is actively engaged in discussions with the NYSE American and is developing plans to regain compliance with the NYSE American’s continued listing standards within the time period indicated.
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 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/20230602005389/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Welcomes Jill Bieker Stefanelli, Ph.D. to Board of Directors; Alexander L. Cappello Steps Down
In line with the Company’s Fix, Fund, Propel approach, Jill Bieker Stefanelli, Ph.D. joins Board, adding precision medicine and product development depth in support of stated strategy to advance innovative technology to market. Separately, Alexander L. Cappello steps down.
DUBLIN, Ohio, June 01, 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 Jill Bieker Stefanelli, Ph.D. has joined the Company’s Board of Directors, adding deep experience developing and advancing precision medicine products in line with Navidea’s stated objectives and its Fix, Fund, Propel approach to advancing innovative technology to market. Separately, Alexander L. Cappello has stepped down from the Company’s Board.
Results-Driven, Experienced, Precision Medicine Leader and Strategist
Jill Bieker Stefanelli, Ph.D. joins Navidea’s Board of Directors with demonstrated experience leading fast-paced organizations focused on transformative precision medicine. Dr. Stefanelli’s career and expertise within pharma and commercial client markets strengthen the Board’s ability to guide product strategy, partnership development, and delivery of shareholder value.
"Dr. Stefanelli adds a strong and experienced voice who will press the business forward," said Dr. Jason Myers, Owner and Founder of G2G Ventures. "She is a true scientist and an expert in the industry, with a career progression that includes research, commercial development, product strategy and proven leadership at all levels. Dr. Stefanelli understands our vision, and offers perspective to help lead Navidea’s technology and assets to the forefront."
Dr. Stefanelli is currently the founding consultant of a consulting practice focused on supporting Precision Medicine Companies including genomics, digital pathology, artificial intelligence, therapeutics, and medical devices as a Consultant, Scientific Advisor, or Independent Board Member. Previously, her experience includes serving as President, Board Member, and Chief Business Officer at Paige, as Senior Vice President and Head of Partnerships at Invitae/ArcherDX, as Clinical Commercial Development Lead at Life Technologies, as a Genomics Specialist at Roche Diagnostics, and in science and microbiology roles with Genewiz, USDA APHIS and Sandia National Laboratories. Dr. Stefanelli earned a B.S. in Animal Sciences & Industry, M.S. in Food Science/Microbiology, and Ph.D. in Molecular Medicine and Diagnostic Pathology within the Department of Diagnostic Medicine/Pathobiology from the Veterinary School of Medicine at Kansas State University. Her teaching experience includes instruction related to veterinary virology, food microbiology and automation in microbiology, and Dr. Stefanelli has published in peer reviewed journals throughout her career.
Separately, Alexander L. Cappello, after having joined Navidea in 2021 and recently serving as Chair of the Board, has decided to step down to pursue opportunities outside the organization.
"We thank Mr. Cappello for his contribution," said John K. Scott, Jr, Navidea’s Vice Chair of the Board. "We wish him the very best in pursuit of his next opportunity, and continue our focus on developing processes and growth strategies led by Navidea’s team of experts and our experienced partners in G2G Ventures."
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 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/20230601006095/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Investors Purchase $1.1 Million in Preferred Shares at Market
Following the Company’s Fix, Fund, Propel approach, the sale of Preferred Shares totaling $1.1 million to new existing investors underscores improved confidence in Navidea’s progress toward advancing its innovative technology to market.
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 sale of Preferred Shares totaling $1.1 million to new existing investors, further supporting the Company’s Fix, Fund, Propel approach and helping to advance Navidea’s innovative technology to market.
Funding Adds Confidence and Fuel for Progress
Supported by G2G Ventures, executive consultants to Navidea with demonstrated expertise in building infrastructure, rigorous process, and proven growth strategies, the Company’s stated Fix, Fund, Propel framework to implement change initiatives which drive effective processes, improve liquidity, and create growth continue to take shape with the recent promotion of Michael Blue, M.D., FACEP to Chief Medical Officer and the sale of $1.1 million in preferred shares to new existing shareholders in the Company. The announced sale provides additional capital to fuel Navidea’s focused efforts to advance the Company’s NAV3-32 and NAV3-33 clinical trials toward completion.
“The additional investment from new existing investors signals growing optimism from our shareholders in the progress we are making to refocus on strategic priorities,” said Dr. Michael Blue, Chief Medical Officer of Navidea. “With G2G’s guidance, and continued support from our partners and shareholders, our experts remain focused on delivering Navidea’s transformative technology to market. We’re making good progress, and staying true to our Fix, Fund and Propel approach. Our opportunity is to improve lives around the world while providing value to our stakeholders, and we expect to continue working to reach those goals.”
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
The securities being sold to the single investor have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon conversion of the preferred shares.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
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/20230522005739/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures - Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Drives Strategy Forward, Shifts Approach for Communications
The company introduces Fix, Fund, Propel approach to further focus on strategic objectives; will publish financial and corporate development highlights via press release in lieu of conference call and webcast for Q1 2023 results.
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 introduction of a Fix, Fund, Propel approach to driving the Company’s strategy forward; The Company will issue a press release detailing financial highlights and corporate developments in lieu of hosting conference call and webcast for the first quarter ended March 31st, 2023.
Fix, Fund, Propel
G2G Ventures, executive consultants to Navidea, with demonstrated expertise in building infrastructure, rigorous process, and proven growth strategies, is supporting the Company’s strategic planning and change initiatives to drive effective processes, improve liquidity, and create growth. The Company, with G2G’s support, has adopted a Fix, Fund, Propel framework to enact change within the organization.
NEWS -- Navidea Biopharmaceuticals, Inc. Announces Intent to sell Cardinal Milestone Payment for $8 Million; Secures New $2.75 Million Equity Line of Credit
Fresh capital for funding Phase IIb and Phase III trials, expands growth, and fuels shareholder value
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announces the execution of a letter of intent to sale the Cardinal Milestone Payment for $8 million and execution of a new $2.75 million Equity Line of Credit, led by a longtime Navidea investor, to provide substantial funding for the Company’s Phase IIb (NAV3-32) and Phase III (NAV3-33) trials and expand operations.
The Company’s uniquely structured capital raise will provide access to up to $10.75 million and propels the organization forward by providing substantial funding for the Company’s current Phase IIb and Phase III trials. Working closely together with its trusted partner and longtime investor, the Company has agreed to sell the Cardinal Milestone Payment for $8 million, subject to execution of final documentation. This sale will bring in immediate capital into the Company, along with access up to $2.75 million with use of an Equity Line of Credit. This powerful combination of capital access allows the Company to expand its clinical trial base – driving additional shareholder value.
“This capital infusion provides an immediate and positive impact on the trajectory of the Company’s pioneering work - empowering accelerated progress in areas of focus for 2023 and 2024,” said Dr. Jason Myers. “G2G and Navidea, now with the added support of this new partnership, are excited to demonstrate our combined ability to advance innovative science and drive shareholder return.”
“Our goal is to partner with trusted investors who share our vision to drive Phase IIb and Phase III trials to completion, enhance our operational capabilities, and continue our strategy of cultivating growth,” said Board of Directors, Director Josh Wilson. “This partnership and structure creates exceptional enterprise value and provides the fuel needed for growth now and into 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, 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/20230427006002/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
G2G Ventures- Executive Consultant
Theodore Gerbick
Chief Marketing Officer
mailto://tgerbick@g2g.ventures
NEWS -- Navidea Biopharmaceuticals, Inc. Enters Asset Purchase Agreement with Meilleur Technologies, Inc. for Rights to NAV4694
The Asset Purchase Agreement allows Meilleur Technologies, Inc. to develop and commercialize markets while Navidea Biopharmaceuticals, Inc. receives additional liquidity for focused growth.
DUBLIN, Ohio, April 13, 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 it has signed an Asset Purchase Agreement allowing Meilleur Technologies, Inc. (Meilleur), to acquire certain assets and assume certain liabilities of Navidea relating to developing and commercializing NAV4694 for a purchase price of $750,000 plus significant milestone and sales related future payments.
The agreement is related to NAV4694, a beta-amyloid imaging agent being evaluated as an aid in the differential diagnosis of early-onset Alzheimer’s disease, providing an exclusive license for Meilleur to develop and commercialize NAV4694 worldwide.
"This is a significant partnership and step forward for everyone involved," Rick Hiatt, President & CEO of Meilleur Technologies, Inc., said. "Meilleur is focused on enhancing access to key technologies which advance and improve brain health, and our transaction with Navidea aligns perfectly with our focus."
According to the terms of the agreement, Meilleur remitted a cash payment of $250,000 to the Company at closing and agreed to an additional cash payment of $500,000 to the Company within 60 days after the closing date. In addition, certain future milestone-related and contingent payments may be made by Meilleur to the Company, based on potential licensing events, regulatory submissions and regulatory approvals, and net sales of approved product derived from NAV4694.
"Our strategy includes building process rigor to advance our therapeutics and clinical trials while also cultivating growth in new markets," Dr. Jason Myers, owner and Founder of G2G Ventures, stated. "This partnership allows us to propel the former while developing the latter, and we are pleased to be working closely with Meilleur’s team of experts on the market development side."
About NAV4694
NAV4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate intended for use in Positron Emission Tomography (PET) imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer’s disease (AD). NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in scans. Beta-amyloid plaque pathology is widely used in the diagnosis of AD. The ability of NAV4694 imaging to display amyloid plaque pathology may enable earlier identification of AD and improve monitoring of disease progression and interpretation of brain scan images. There is an ongoing NAV4694 Phase 2b trial in Mild Cognitive Impairment and a Phase 3 program for NAV4694 in AD.
About Meilleur Technologies
Meilleur Technologies’ vision is to globally develop diagnostics and technology that will impact patients with neurodegenerative disorders including Alzheimer's disease. Meilleur’s affiliate company, Cerveau Technologies, Inc., has recently announced its acquisition by Lantheus Holdings, Inc. which will continue to develop and scale Cerveau’s novel Tau tracer which is proving to be critical to the overall management of Neurodegenerative disease.
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 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/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Joseph Meyer - Director of Finance and Accounting
mailto://jmeyer@navidea.com
(614)-793-7500 X 2370
NEWS -- Navidea Biopharmaceuticals, Inc. Hires G2G Ventures as Executive Consultants; Chief Medical Officer Steps Down
Executive Consulting buttresses senior management’s focus on performance and targeted growth. Chief Medical Officer, Michael Rosol, Ph.D., steps down.
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announces the Company has hired G2G Ventures (G2G) as Executive Consultants to provide executive team support for Navidea’s aggressive growth plans. Separately, Michael Rosol, Ph.D., has stepped down as Chief Medical Officer for the Company.
Supporting the Company’s focus on targeted growth initiatives, Navidea has hired G2G Ventures, a specialized firm led by Dr. Jason Myers, former CEO of ArcherDx and a graduate of the Stanford University School of Medicine (Molecular Pharmacology) with a wealth of experience in creating, leading and growing innovative medical technology companies, as Executive Consultants. G2G Ventures’ hiring will drive the activation of the organization’s visionary objectives by infusing proven growth strategies into business development and operations, enhancing financial reporting capabilities, and leading effective investor communications.
"We are incredibly excited to work with this unique organization,” Dr. Jason Myers, Owner and Founder of G2G Ventures, said. “We have deep expertise in translating technologies into differentiated products, in building infrastructure and rigorous process, and in commercial strategies that drive new market development. We are eager to partner with Navidea to bring their underappreciated technology and assets to the forefront.”
After serving as Chief Medical Officer for the Navidea since 2018, Michael Rosol, Ph.D., has decided to step down to pursue opportunities outside the organization. The role of Chief Medical Officer will be assumed by existing leadership with coordinated support from G2G Ventures. Further, Dr. Rosol will provide transition consulting services to the Company to continue to support its progress and growth.
“We appreciate Dr. Rosol’s contributions towards advancing the science behind our therapeutics and clinical trials,” said Alex Cappello, Navidea’s Chairman of the Board. “We wish him the very best in the next chapter of his career and continue to look ahead with a focus on developing new market growth with the support of our team and our experienced partners in G2G Ventures.”
“I am very appreciative of my time at Navidea and am privileged to have worked with the outstanding team at the Company,” said Dr. Rosol. “I continue to be extremely enthusiastic about the science and potential of the Manocept platform to create positive impact in both the therapeutic and diagnostic spaces, including in the advancing Phase IIb and Phase III trials in rheumatoid arthritis.”
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 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/20230330005793/en/
Navidea Biopharmaceuticals, Inc.
Joseph Meyer - Director of Finance and Accounting
mailto://jmeyer@navidea.com
(614)-793-7500 X 2370
NEWS -- Q4 2022 Navidea Biopharmaceuticals Inc Earnings Call
Participants
Alexander L. Cappello; Independent Chairman; Navidea Biopharmaceuticals, Inc.
Erika L. Eves; VP of Finance & Administration and Principal Financial & Accounting Officer; Navidea Biopharmaceuticals, Inc.
Joseph W. Meyer; Controller; Navidea Biopharmaceuticals, Inc.
Michael Stanley Rosol; Senior VP & Chief Medical Officer; Navidea Biopharmaceuticals, Inc.
Edward English
Unidentified Participant
Presentation
Operator
Greetings, and welcome to the Navidea Biopharmaceuticals Fourth Quarter Earnings Call and Business Update. (Operator Instructions) And as a reminder, this conference is being recorded.
It is now my pleasure to introduce to you, Dr. Michael Rosol, Chief Medical Officer. Thank you, Mike. You may begin.
Michael Stanley Rosol
Thank you, and thank you all for joining us here today for the earnings call and business update. This call is being webcast live on our website, ir.navidea.com, and a replay will be made available. Following prepared remarks, we will be conducting a live Q&A session, as you've just heard.
Navidea's Chair of its Board of Directors, Mr. Alex Cappello; the Vice Chair of its Board of Directors, Mr. Kim Scott; its Vice President of Finance and Administration, Ms. Erika Eves; and its controller, Mr. Joe Meyer, are all joining me on the call today.
During the course of this conference call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Navidea's molecular diagnostics and immunotherapeutics, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters. All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks and uncertainties and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise. Investors should read carefully the risks and uncertainties described within the safe harbor section of our website as well as the risk factors included in the company's most recent quarterly and annual filings with the SEC.
As we begin our update and look back at events from Q4 to date, I thought it would be helpful to reiterate a few of our key areas of focus in our 2023 planning. One, we will continue RA, rheumatoid arthritis, Phase III trial success to full enrollment, NDA submission and FDA approval. Two, we'll fully fund the Phase III trial, and the Board of Directors is actively engaged in discussions with capital providers in support of our mission to identify this full RA trial funding. Our goal is to be fully funded this year. Three, we'll attract and retain the industry's top biopharmaceutical talent. As our RA development program success grows, so does the need to grow our team to help support key milestone achievements, identify and support key strategic relationships and initiate new PR IR efforts as a way to share our trial and milestone success.
As I mentioned a moment ago, on the financing front, the Board of Directors is actively engaged in our financing effort, and we hope to have news to announce there shortly. In the last quarter, we have advanced our clinical trials in rheumatoid arthritis as well as our pipeline in other diagnostic indications and in therapeutics. We continue to make solid progress on our Phase IIb trial in rheumatoid arthritis comparing imaging to biopsy. And during Q4, we presented at an international conference our updated promising preliminary results supporting tilmanocept's ability to distinguish the fibroid pathotype from the nonfibroid in the first 13 participants evaluated by the time of the presentation. These strong early results support our hypotheses and provide excellent data in support of tilmanocept imaging as a biomarker of CD206 expression in joints of patients with RA.
We also continue to enroll into the RA Phase III and are actively enrolling in 12 sites. We continue to advance our therapeutics and imaging applications through key existing collaborations with well-known institutions and investigators across the globe as we work to grow the company's intellectual property. We are proud of the progress we have made and the planning we are putting in place to benefit our associates and our shareholders here at Navidea. Regarding the CRG and Dr. Goldberg litigation matters, the company has that ruling that essentially bracket its exposure in both. We will continue to minimize exposure.
Now I'd like to provide a brief update specific to our clinical results. So I'll begin with the progress in our rheumatoid arthritis program. In NAV3-33, the Phase III, we continue to have good enrollment into this Phase III trial in RA. The initial indications we are pursuing for FDA approval are: one, early prediction of treatment response to a new or first-time anti-TNF alpha therapy; and two, identify RA patients with low level of localization of tilmanocept, who are less likely to respond to anti-TNF alpha therapy.
As we have discussed previously, there is a large unmet need for a reliable early predictor of whether a therapy is working in a patient with RA. Because if the drug is not working, the patient's disease is not being treated, and this can lead to long-term health consequences, along with unnecessary high drug costs for ineffective therapies that also bring with them possible side effects. Our Phase III trial will establish the ability of tilmanocept imaging to serve as an early predictor of treatment response in RA patients switching to an anti-TNF alpha therapy, addressing that unmet medical need.
In NAV3-32, our comparison study of tilmanocept imaging to joint biopsy, we remain in active recruitment. As we've announced and discussed previously, the preliminary results of this trial have been promising. Our aim is to recruit patients with each of the 3 pathotypes of RA to obtain comparative imaging and pathology results. And the trial is designed so that we enroll a minimum of 4 subjects in each of the 3 subtypes of RA: fibroid, diffuse myeloid and lympho-myeloid. So overall trial size has been expected to range between 12 and 24. To date, we have achieved our enrollment targets in 2 out of those -- 3 of those pathotype buckets, with patients having had both their imaging and joint biopsies completed.
The primary objective of this study is to assess the relationship between joint-specific tilmanocept uptake values and the pathobiology of the RA-involved joints. 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. There is a growing body of literature suggesting that those patients with the fibroid type of RA are much less responsive to the anti-TNF alpha drugs, and so a means of determining whether or not a patient has this particular pathotype is seen as extremely important to a number of key opinion leaders in rheumatology. As of this time, there is no reliable way of assessing a patient's pathotype of RA other than by doing a biopsy, and we have hypothesized that tilmanocept could provide this information.
So we presented updated preliminary results on the first 13 patients back at November's American College of Rheumatology meeting. That's the largest rheumatology conference in the world. These results presented there indicated that tilmanocept uptake in the RA-inflamed joints is able to discretely differentiate patients with the fibroid pathotype, that is patients with low macrophage involvement, from those having either the diffuse myeloid or lympho-myeloid types of RA, that is patients with higher macrophage involvement.
So these data also provides support for one of our indications in the Phase III trial. The ability to predict from a baseline scan alone, whether a patient is likely to receive a meaningful clinical benefit from an anti-TNF alpha therapy. Since, as I mentioned, there is increasing evidence that if a patient has the fibroid type of RA, they are less likely to receive significant clinical benefit from anti-TNF alpha therapy.
You might recall that in our previously completed Phase IIb study, NAV3-31, that contained a pilot arm looking at the efficacy of tilmanocept imaging at early prediction of treatment response, those patients who exhibited a low level of tilmanocept uptake in their joints on their baseline scan before they started therapy had an almost 90% nonresponse rate to anti-TNF alpha therapy using a clinical gold standard assessment. Importantly, these promising early results have opened up conversations with pharmaceutical companies who are developing therapeutics for RA, with the possibility of tilmanocept imaging being used as a biomarker in their drug development pipelines. The key differentiator between now and prior discussions we have had with these kind of companies is that we have this additional promising data in hand. And as we move forward and gather more data towards trial completion, if these current results hold, we will be in an even better position for discussions with companies with which to work.
We continue to make very good progress on automating the imaging quantification as well, which will have significant benefit for the commercial product. We are working closely with MIM Software, M-I-M, on a definitive agreement for them to be our commercial partner for image quantification of tilmanocept imaging in RA. So once again, MIM is a leading medical imaging software company based in Cleveland with a large footprint in the nuclear medicine space. We are currently integrating their existing image analysis workflow into our Phase III trial, and their software should be used for the image analysis for this trial as well as our normative database trial data.
The workflow for these trials is extremely well designed. And by integrating them into our trials at this stage, this should be helpful for development and integration of a fully automated workflow that they are developing. Already, they have completed a pilot study using data from our earlier trials, demonstrating that they can develop this fully automated application that should be able to robustly reproduce our quantitative imaging reads using our proprietary algorithm.
This is important for rollout of a commercial product. The ability to perform the quantitative imaging reads rapidly and reproducibly without having to have a bunch of people in the room actually drawing the reference regions of interest will help us go at large scale through this automated method, and that will be critical to large-scale adoption of tilmanocept for RA. Keep in mind that all of this, the image analysis methodology as well as the data upon which it is built, including the normative database you've heard us discuss before, is not only critical to driving the most accurate and sensitive objective read of our RA images, but it also serves as a significant barrier to entry to possible competitors in this space.
You might have also seen the conversion of a provisional patent application to an A1 patent application earlier this month. This application involves using clinical and serological markers in combination with our imaging readout to possibly improve our predictive capacity for treatment outcome over using our imaging alone. So we will have IP protection on combinatorial approaches as well if they work and if granted. We have data from the NAV3-31 Phase IIb trial that I just referenced that was completed a while ago that suggests this indeed might work.
In the diagnostics pipeline development, we've completed preclinical studies on gallium-68 tilmanocept for PET imaging and related next-generation Manocept imaging agents. We work on this in collaboration with researchers at the University of Alabama at Birmingham or UAB. We've also completed work on our NIH-funded preclinical studies for evaluating gallium-68 tilmanocept in various new imaging agents similar to tilmanocept in a mouse model of atherosclerosis.
Work on another important set of preclinical studies was completed with our collaborators at UAB. This work explored varying the molecular weights of tilmanocept-like constructs and evaluating their biodistributions, following intravenous injection with and without competitive blocking. Results showed that by varying the molecular weights of these compounds and introducing competitive blocking agents, it was possible to significantly increase localization of tilmanocept-like imaging and therapeutic constructs to target tissues like tumors while concurrently reducing localization to off-target organs such as the liver.
These results show a path to improving our diagnostic imaging and to greater and more effective targeted delivery of our therapeutic constructs to tumors and other sites of macrophage and valve pathology. We presented these results at the Society of Nuclear Medicine and Molecular Imaging meeting last summer, and these were electronically published on March 7 of this year in the Journal Molecular Imaging and Biology, and you can access that online.
On the therapeutic assets front, we are advancing our candidates in the oncology and anti-inflammatory spaces in preclinical studies with the goal of filing investigational new drug applications to advance to human trials in 2024. These filings will be significant inflection points and opportunities for licensing and partnering deals for the company. Work on new drug delivery constructs and new targeted payloads has also progressed. These new constructs carry new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages, for example. Results in mouse models have demonstrated that when administered alone or in combination with another cancer drug, these therapeutic constructs significantly reduce the rate of tumor growth by an average of 76%.
Some of our results covering new bisphosphonate payload constructs were presented at the Tumor Myeloid-Directed Therapy Summit meeting. More recently, on November 10, the full spectrum of results for the paclitaxel and novel bisphosphonate constructs were presented at the Annual Meeting of the Society for Immunotherapy of Cancer held in Boston. In addition, we completed what's called a maximum tolerated dose study in mice for our bisphosphonate-carrying construct. The results of this study will facilitate design of studies intended to evaluate anticancer efficacy of this construct in the future. All of our preclinical work with potential cancer immunotherapy constructs are intended to enable Navidea to choose a lead candidate for macro-type-, phenotype-altering drugs for oncology indications.
Preclinical studies are also ongoing in leishmaniasis. Leishmaniasis is a vector-borne chronic disease caused by a protozoan parasite that replicates in CD206-positive macrophages. It is transmitted to humans through the bite of infected sandflies found in parts of the tropics, subtropics and Southern Europe. It's rare in the United States, but in more tropical countries where the sandfly vectors are found, it is a common serious and potentially life-threatening disease. The U.S. FDA has designated leishmaniasis as a neglected tropical disease, making new therapeutics of this disease potentially eligible for what's called a priority review voucher that Navidea could sell potentially for more than enough to back cover the cost of development as well as accelerate a number of other pipeline candidates.
Previously, Navidea scientists and our collaborators at the NIH published research results demonstrating that high CD206 expressing macrophages play a role in the dominant form of the disease. This project has advanced significantly in the last year with results from 3 separate experiments showing that a novel construct created by Navidea has significant therapeutic potential to control leishmanial infections in mice. Concurrent with reduced numbers of these parasites, alterations in the immune status of the lesions that are caused by leishmaniasis were observed with potential implications for the mechanism of action of our novel therapeutic construct. Additional experiments are ongoing or our plan to follow up on these very promising initial results.
That brings me to our overall intellectual property front. We received notification of issuance of a patent from the United States Patent and Trademark Office for the company's application titled Compositions And Methods For Altering Macrophage Phenotype. This patent covers the ability of our constructs to stimulate an immune response against tumors through targeted delivery of payloads that change the nature of macrophages to make them more pro-inflammatory. Efficacy of these constructs has been demonstrated in preclinical studies, including the ones I just spoke about. We have also received notifications of issuance of patent application of patents in Israel and in Canada. Please refer to the earnings call press release from earlier today for more detail.
So we continue to submit new provisional applications and work on our pending ones. We have filed a new provisional patent application describing a new chemistry for addition of mannose sugars to our mannosylated dextran-based imaging and therapeutic constructs. This new chemistry results in a different linkage holding the mannose onto our constructs, one that is more stable than the linkage currently used, and is designed to facilitate commercial scale-up and production of our next-generation imaging and therapeutic constructs. In partnership with our excellent patent attorneys, we have an active IP protection strategy for the company that will provide needed protections and rights to both our current diagnostic and therapeutic agents as well as to our next-generation molecules and disease indications.
On the Lymphoseek front, regarding Lymphoseek Europe and the rest of the world, our strategy has been and remains to find the right partners for marketing and distribution for Lymphoseek and other company pipeline candidates in Europe and beyond. The reason for this is we are focusing on the long-term strategy of partnering for marketing and distribution.
On the drug manufacturing and supply front for both Lymphoseek and the RA product, we have been and continue to work with a new active pharmaceutical ingredient or API supplier as well as a final drug product supplier. Progress continues. And as of this time, we are advancing towards completion of these and readiness for clinical and commercial supply. This work has implications for Lymphoseek in China and Lymphoaim in India as we need to be able to supply a steady and reliable stream of product through our partners in these countries.
So these are just some of the highlights of the last quarter that we wanted to touch on for this update. We remain largely focused on the RA pipeline, specifically the Phase IIb imaging, the biopsy trial in the Phase III, while we continue to support and push progress on our other diagnostic and therapeutic indications.
As always, I want to thank the team here for their tireless efforts to keep things moving and our network of clinical trial sites and academic research collaborators for all of their hard work. Our business strategy remains to advance our pipeline products to key inflection points and seek appropriate partnerships for commercialization and marketing.
So with that, I'll close the update -- summary update. I want to thank you, and I'm going to turn it over to Erika now for the financials.
Erika L. Eves
Thank you, Mike. As announced last week, I will be leaving Navidea at the end of the month. Our current Controller, Joe Meyer, will be taking over many of my responsibilities. So I'd like to introduce all of you to Joe, who will now read the financial results for the fourth quarter and full year of 2022. Joe?
Joseph W. Meyer
Thanks, Erika. And for the first time, hello, everyone. Total revenues for the 3-month period ended December 31, 2022, were approximately $1,000 compared to $50,000 for the same period in 2021. Total revenues for the year ended December 31, 2022, were $66,000 compared to $532,000 for the same period in 2021. The decrease was primarily due to the 2021 partial recovery of debt previously written off in 2015, the 2021 receipt of reimbursement from Cardinal Health of certain research and development costs, decreased grant revenue relative to small business innovation research from NIH supporting Manocept development and decreased license revenue from transitional sales up to Manocept in Europe.
Research and development expenses for Q4 were $1 million compared to $1.4 million for the same period in 2021. R&D expenses for the full year 2022 were $6.0 million compared to $5.1 million for the full year 2021. That year-over-year increase was primarily due to increased drug project expenses and increased employee compensation, including incentive-based awards, offset by decreased regulatory consulting expenses.
Selling, general and administrative expenses, or SG&A, for Q4 were $1.3 million compared to $2.3 million for the same period in 2021. SG&A expenses for the full year 2022 were $8 million compared to $7.5 million for the full year 2021. Following the ruling by the Texas Court in August 2022, the company recorded $2.6 million of legal fees in SG&A pursuant to the CRG judgment. The year-over-year increase was also due to increases in insurance and depreciation and amortization, partially offset by decreases in employee compensation, including fringe benefits and incentive-based awards, expenses related to European operations, travel, legal and professional services, investor relations and shareholder services, general office expenses, facilities costs, losses on the abandonment of certain intellectual property, and franchise taxes.
Navidea's net loss attributable to common stockholders for Q4 was $3.5 million or $0.11 per share compared to $3.7 million or $0.12 per share for the same period in 2021. Navidea's net loss attributable to common stockholders for the full year 2022 was $17.2 million or $0.56 per share compared to $11.7 million or $0.40 per share for the full year 2021. Navidea ended the fourth quarter of 2022 with approximately $2 million in cash and cash equivalents.
And with that, I'll throw it back to you, Mike.
Michael Stanley Rosol
Thank you, Joe and Erika. Thanks for everything, Erika, that you've done over the years, not just my years here, but before.
And now I'd like to open up the call to questions. I'll let the moderator do that more professionally than I just did. Joining me for the Q&A session, of course, will be the folks here in this room, myself, Erika, Joe. And then indeed, we have Alex Cappello, the Chair of our Board; as well as Mr. Kim Scott, the Vice Chair.
Question and Answer Session
Operator
(Operator Instructions) And the first question comes from the line of Edward English, a private investor.
Edward English
Mike, this is Eddie English. Before I ask my first question, though, I would like to extend a shout-out to Erika Eves for the 30-plus years of service and support, not only to Navidea but us, shareholders, and to wish her the very best in her new endeavors.
With that, Mike, the elephant in the room based on the report that came out this afternoon, in my mind, is the current cash position with only $2 million at the end of the fourth quarter and a historical cash burn rate of $800,000 to $1 million a month. Can you shed some light on how far in the future you all can operate with your existing cash reserves?
Michael Stanley Rosol
Eddie, thanks for the question, and I appreciate the shout-out. I'm sure Erika does to her.
Erika L. Eves
Thank you. Appreciate it.
Michael Stanley Rosol
Yes. In any event. So Eddie, great question. Really, it's no secret that the company has been in a resource limited environment, but we are optimistic that we'll have something to announce around capital infusion soon. As I mentioned, the Board -- members of the Board are working diligently on this, and that's really all that we can say about it at the current time. I appreciate the question, though. So that's really what we can say right now.
Edward English
Okay. One follow-up, and I'll abide by the rules and then go back in the queue because I have a few more. But my next question is around your plans to become NYSE-compliant by July 28. Are you all on schedule to meet that deadline? Or what can you tell us about that?
Michael Stanley Rosol
I'm going to let Erika use her great financial wisdom to have one -- she should have something to say on this last Q&A. Go for it, Erika.
Erika L. Eves
One final word for me. Yes. So obviously, one of the biggest issues facing us is the NYSE cure that is required, and I think the financing that the Board is currently working on should go a long way towards satisfying the requirements. And so I would say at this time, expectations are that we will indeed become -- regain compliance with NYSE by the end of the cure period.
Operator
And our next question comes from the line of [Bert Carlson] with -- another private investor.
Unidentified Participant
Yes. I appreciate you touching on Lymphoseek a few minutes ago. I wanted to -- hopefully, you can expand a little bit on that. I know that it's been 8 years since we've retained the international rights to selling Lymphoseek. And in all that time, it appears we've not been able to generate any significant revenue. And I wanted -- if you could put your honesty on this, is there something more specific that we could do to make this happen? Or is Lymphoseek a lost cause at this point?
Michael Stanley Rosol
Yes. Great question. I'm happy to answer and give you as much transparency as possible. So that's a summerlong story that I'll try to stick to a shorter version of. So as you and others know on this call, we -- Navidea had licensed the European rights to Lymphoseek to a company called Norgine. And they're a fine company. Their strategy, we might say, was probably not optimal strategy for penetrating the market of sentinel lymph node biopsy assessments or lymphoscintigraphy in Europe.
And it's not all just on their strategy. See, in Europe, there is a viable competitor for Lymphoseek. It's a version of -- it's a colloidal compound. There are different names, but one of the common names is Nanocoll. And it's a pretty good agent, right, for -- and it's relatively inexpensive. In fact, it's actually very inexpensive, and it's pretty good.
We and others, and there's a growing body of research that supports this, suspect or believe that there are advantages to Lymphoseek over this product that has really dominated the market in Europe for years. So Norgine didn't do maybe the optimal strategy for penetrating a market that already has a viable product. We do think there are advantages to it. And to be fair to Norgine, it's been years in the making that researchers have produced publications that support what I just said is our belief, that Lymphoseek has advantages.
So one thing we think Norgine did maybe that wasn't what we would do is they priced Lymphoseek at a premium without having enough of these data in hand to make the case in the very highly regulated European market to adopt Lymphoseek over a good product. That make sense? So what we have done is we brought back the rights, as you probably know, Lymphoseek Europe to Navidea. And we've spent a significant amount of time getting our API and drug product development processes in gear so that we could potentially supply the European market as well as the rest of the world with Lymphoseek and/or the RA product.
So with all of that said, we are actively in discussions with possible partners for Lymphoseek in Europe because it is not just us and some KOLs who believe there are advantages of Lymphoseek to Nanocoll or these Nanocoll and related products, but there are other possible partners who believe it as well. Having said that, it's -- there is a viable product out there, and so the case must be made strongly in a very highly regulated environment in Europe. So there are a lot of -- it's not quite as smooth sailing as it is in the United States. That's maybe too much flavor or detail for you. But it is a product that we think has advantages over the existing product that dominates, and we are in discussions. And if I didn't say that in this call, I think I did, we've said it before. And so we'll continue to have those and see what the market will bear, but we're optimistic. That's about as honest as I can be.
Operator
And the next question comes from the line of [Mike Rashal], a private investor.
Unidentified Participant
Yes. Erika, like everyone, we wish you well in the future. Thanks for your 31 years. And Joe, welcome on board. My question -- initial question is observation first. I think there's a great under-appreciation for this patent that you received on the M1/M2 reprogramming in the TAMs that I just felt the market appreciated it yet, and I don't know if many investors had appreciated it. To me, it seems quite outstanding.
But taking that as an observation, there's also been a lot of science developed, Dr. Rosol, over the last little while that M1/M2 programming, whether in reverse or inverse, also may be applicable in many other diseases and inflammations. Can you expand on that a little bit? And do you believe that you will be -- we'll be seeing patent applications on that in the future?
Michael Stanley Rosol
Yes. Thanks, Mike. Right on all counts and good questions. So some background for the folks who are so in-depth into the field. Very broadly speaking, there are -- macrophages can be pro-inflammatory, stimulate an immune response. That's the so-called M1 macrophages that you just heard Mike refer to. And then there are M2 macrophages that are more -- they have the opposite kind of effects. The wound healing, they quiet down the immune response. Some people would say, in tumors, paradoxically, they're pro-tumor, actually. So there are these kind of extremes of the macrophage in the macrophage world.
And looking at changing the phenotypes of the macrophage, driving them from one of those, the M1, for example, to the M2 or vice versa is a very hot topic across the world because macrophages are very powerful and prevalent cell type in the body, and they're involved in almost all diseases, really. And so the opportunities there to help people to treat diseases is enormous.
Macrophages play a key role in cancer growth and metastases. And in cancers, the macrophages that dominate in and around the cancers are the kind of wound-healing, so-called pro-tumor types of macrophages that actually act as a kind of force field around the tumors to prevent the body's natural immune response from attacking the tumors.
And so what we and many other organizations are doing across the globe related to specific cancer is we're looking at therapies that -- or treatments that might change the phenotype or the nature of the macrophage and drive them from the wound-healing M2s to the pro-inflammatory M1s. And if you can do that in people who have cancer and in those tumors themselves, you can then rally the body's immune response to attack the cancer.
And as of May of 2021, to give you an idea of how large these efforts are globally, to do just what I told, there were 606 clinical trials that we're running or have been completed just to do what I just said related to cancers. It's a huge field. And you know what's cool about it is, really, we're at the forefront of that, not necessarily in the progression of our therapeutic constructs into humans, but in the technology and what our drugs have been show -- what we have been able to show they can do in the in vitro or preclinical phases.
So we're right there at the leading edge of this incredibly large opportunity field or space to help patients and to treat a large number of diseases from cancers to others. I can get into that in a moment. And that patent that Mike referenced was about -- was giving us our intellectual property around using our constructs to change the phenotype of the nature of macrophages, as I just described. And yes, there are going to be a whole series of patents that follow suit or applications around that.
The fact that we can target macrophages of all type, the M1s, the M2s and everything in between, with our construct means that we can deliver all sorts of cool things, payloads, they're called loosely, to the macrophage. And we can perturb them and drive them in different directions. And we have a very flexible, adaptable molecule that has all sorts of really great advantages over what almost every other group out there is using. So I'm not just saying that because I work here. It's proved.
And so we have this great opportunity to be able to really shake up the world in these therapeutic domains. And one of the major thing holding us back as a small company, of course, has been resources, financial resources. So we're very good at making a lot happen with a little. And so our goal, of course, this year, and you've heard it before, but I believe significantly that things are different now than they used to be, our goal is to be fully funded so that we can help drive those things towards first-in-human trials, which is where we can -- those kinds of inflection points are opportunities for large investments, whether they be partnering or license deals or whatever, or whatever we might decide to do. So we're trying to drive them towards that.
So I might have gone astray from what you originally asked, but that patent is very important. There will be others coming along the way that are related. There are some already. You just don't know about it yet because they're not published. And this is a very hot and exciting area in not just cancer research but in other diseases.
So I've mentioned in cancer, you want to drive the M2 or wound-healing pro-tumor type macrophages to M1 pro-inflammatory. In many other diseases, including almost all inflammatory and infectious diseases, you want to do the opposite. You want to take the inflamed pro-inflammatory macrophages that are doing a lot of stuff to try to attack whatever the infectious agent is, but the body has a hard time controlling those things precisely. So what you want to do is you want to drive those towards the more wound healing-type. And we have data suggesting that we can do that with our dexamethasone constructs.
So we can perturb the macrophages and drive them in one direction or the other. And with that, the world is kind of our oyster, and almost every disease is touched by the macrophage, or the macrophage plays a central or critical role. So that's my spiel. Hopefully, I addressed your question, Mike.
Unidentified Participant
You did an excellent answer. So my follow-up on that is an observation that I can make, and maybe you can't opine on it. But I think it's opening up the IND that will really open this up to the world. And on that, do you have any other guideline you can give us into 2024 on your target range for that IND?
Michael Stanley Rosol
Yes, sorry. Thanks. I think that's still our goal and our objective. Obviously, it will be really helped -- will have significant help propelling us forward with full funding, but that is still an achievable goal because we've advanced some of these significantly in the preclinical space. And what you want to do to get towards that IND, the other kind of 2 dominoes that need to fall, roughly speaking or at a high level, are you need to establish that in preclinical models that your construct or your therapy is safe and tolerated, and there are some specific studies you have to do for that. But they're very well known and established and we can box those out, and we've already accounted for those in our time line.
And then the other thing you have to do is show that you can actually make the drug in a scalable fashion and it's reliable and safe to be injected. And so those are the other 2 dominoes that need to fall. It's fairly reasonable for us, we think, to get to those in the time lines you've seen with the caveat always we need to be resourced properly.
Operator
And the next question is a follow-up from Edward English, a private investor.
Edward English
Again, Dr. Rosol, I'm curious, I've noticed in what's available to us in the public and the securities and exchange filings that there haven't been any stocks granted to the Board of Directors since late November. I haven't seen any Form 4s. Has something changed with the compensation for the Board? Are they now receiving cash? Or can you elaborate on what's changed? And if so, why?
Michael Stanley Rosol
Go on, Erika, please.
Erika L. Eves
Yes. So in late 2021, the directors adopted a compensation plan for the next 12 months. Due to our funding situation, many of the directors have chosen to defer compensation until we achieve full funding. And so I can't really speak for the Board, but I believe that, that may have had something to do with their decision to not award themselves an additional package this year. I think that they are probably waiting until we feel like they don't have to defer any longer.
Alexander L. Cappello
Actually, several months ago, all of us were -- had cash payments suspended. So we've all been working several months without compensation and some for the whole year.
Edward English
Next question, a follow-up, and that will be my question for the day. You still have the third-party assessment for the use of the tilmanocept in the RA program. It's still out on the site, and it has revenue projections that are quite appealing. And I'm just curious if you all still stand by those projections. I think there's some $41 million in revenue projected for the year 2024. Have those projections slipped or changed in any way?
Michael Stanley Rosol
Yes, this is Mike. So the numbers, I think, are solid numbers in terms of the market potential and the growth curves even. Those are always based on modeling.
In terms of the time lines, I mean the -- we're doing our best to meet the time lines that are on the investor deck that is out there right now. But to be honest, some of these projections were based on opening up a full suite of sites or a larger number of sites at a certain stage and then going forward from that period. And we've been, frankly, in a resource limited environment for a while now.
So some of these things are just naturally going to be pushed forward unless -- and this is where it gets very complicated. So I'm not giving you double talk, I'm giving you real talk. Unless the -- we could open up more sites than we built into the original model. Enrollment is always something that we have some control over but not full. And then there are several other factors that are -- including the trial size, which is variable based on the response rate to the anti-TNF alpha therapies.
So you put all of that into the hopper, the resource limited environment where we have not been able to open up all the sites we wanted to yet and some of these other variables, and they can kind of counteract each other. So you end up with the same resolution of everything at the same time or might be driven forward or even happen earlier. So more likely than not, it gets pushed forward a little bit if you have to run a long time without a full complement of clinical trial sites open.
And that's kind of where we are now. So I hope that doesn't sound hand-wavy. But like those -- the first revenue generated may be pushed off a bit, but the numbers themselves and the trajectory, once it happens, we still stand by and believe because we have a good idea of the competitive landscape. And the data that we're bringing to the table so far are significantly better than anything I've seen out there. That make sense?
Edward English
Yes. If I could summarize, I think you're telling me the potential is still there and it's very robust, but the timing could go either way.
Michael Stanley Rosol
You got it. Yes.
Edward English
Okay. Well, I'll end it there and just say certainly looking forward to some news soon on your financing.
Operator
And the next question is a follow-up from [Mike Rashal], private investor.
Unidentified Participant
Yes. Dr. Rosol, 2 follow-up questions. You mentioned briefly that as you advance the science engagement, future funding partners improve. Are those still active talks ongoing on the RA [BP] partner potential? Is that still in the works and still progressing?
Michael Stanley Rosol
Thanks, Mike. Yes, that's a -- and there's a complicated answer behind that. The answer is yes, we're still in -- and I've said this, so I can say it now. We're in discussions related to the implementation of -- or the use of tilmanocept in partnership with other drug development companies. And those are -- there's a lot of interest in the NAV3-32 Phase IIb study for that.
In terms of the overall business partner for RA, I think there are opportunities to discuss as we roll with other possible -- with possible business partners as we roll into -- through the trials. But really, and again, to be honest, what I think, Mike Rosol, the place where you're in the best position to get the most bang for your buck is when you've completed the trials and have strong data in hand. From that point on to -- all the way to and into or through FDA approval, that puts you in the strongest position, I believe, because then you have a proved-out, to one degree or another, diagnostic.
So again, if you want me to be completely honest here, doing deals earlier, you usually -- you give up something because there's more risk, right? It's all about the rNPV, right? So the longer we can go, if we can be fully funded and drive this towards completion of a trial, good data, FDA NDA submission, believe me, then we're in the strongest position to do a deal.
So I think that's the strategy that you should pursue, at least if you can, and we're trying to do that strategy. It doesn't mean if something happens in the intervening months or so, we're not turning it away, we're listening. But we want to make the best that we can of what we've got here. And really, that's the story. So...
Unidentified Participant
Well, I think taking that approach of extracting the best value with the most informed and progressed results is -- would be the desired way to go. And I think I'll finish with the comment that you made in the rheumatoid arthritis treatment patent application that should encourage people on this and in 2 of the embodiments in 106 and 111. It was stated that the exciting perfect prediction and remarkable test responses were generated in that testing for the treatment. Can you expand on any of that? Because that just exemplifies and amplifies the potential of this RA, the results you were seeing in the treatment RA -- of the RA patent application. Can you comment?
Michael Stanley Rosol
Sure. So thanks for that. That patent is primarily about the -- using a combinatorial approach for achieving a better prediction capacity for our imaging agent for predicting treatment response in RA. And so we know that our -- that in the data so far, tilmanocept imaging is a very good predictor in the data so far of clinical outcome at 3 and 6 months.
And what we started to look at after the Phase IIb study was, could -- is it an independent and additive predictor to other clinical serological biomarkers, which for the most part or entire part have really kind of failed to be adequate on their own or even in combination? Although there's a lot of people looking at different combinations.
So we looked at our imaging prediction in combination with all sorts of different clinical and blood-based, that's what I mean by serological, biomarkers that are normally obtained in RA patients. And we looked at these in all sorts of different cool ways, and what we found was that it looks like -- and we only have limited data to date. But it might be that our -- if we take our very powerful imaging readout and combine it with some readily available and already validated clinical biomarkers, we might be able to improve our prediction capacity, in some circumstances, the upwards towards a sensitivity of 100, right, or perfect.
Never going to be perfect across the world, across everybody, across all time. But it's really about taking a combinatorial approach of our imaging readout with other biomarkers that are available. And it looks like there might be value there. And by filing that patent, then of course, we have the intellectual property protection.
And insofar as it relates to therapeutics, that should be therapeutic-agnostic. Although to date, we've only looked at the anti-TNF alphas. So the exciting thing there is, what we've learned to date is our imaging readout is an objective, independent predictor of whether or not a patient is getting better or not from treatment of an anti-TNF alpha or with an anti-TNF alpha. It's independent of all the other clinical and serological or blood-based biomarkers. That's one, and it's really strong.
If you add some of those, and we're looking to see which is the best combination, then you might improve your prediction, or not much closer because there's not even a lot of ceiling left, but even closer to the ceiling of getting it right all the time or most of the time or the vast majority of the time.
So that's really cool and promising. So we're really trying to get to what is the optimal predictive capacity for any patient. Is their drug going to work or not? Or is it working or not early? Now related to the therapeutics, it's less specific in that it's not really specifically outlined in that patent. However, the fact that we can deliver and we've demonstrated that we can deliver an imaging probe to RA-inflamed joints, and we can do this reliably, repeatedly and stably, it should not escape your attention that then we could easily swap that out for a therapeutic.
So we believe that we also have a potential powerful therapeutic in our hands, pardon the pun of hands. But -- and that remains to be explored more fully when the company is funding. But indeed, we have the potential for a powerful therapeutic. And what we're doing in that patent application is showing that on the diagnostics side, we really have all the bases covered. That make sense?
Unidentified Participant
Yes. So on a therapeutic, did you guys do -- have you done any preclinical, just small test to see if that therapeutic validated that concept you just talked about that's not in the patent? Have you tried anything? Or I imagine you have.
Michael Stanley Rosol
Yes. There were preclinical studies that have been done in the past, and there was some promise to those. So let me leave it at that. But really -- and we have a plan for how we can go forward and really flesh that out. But in the limited data that I've seen to date, and much of this predates my time here, there was already promise shown. And we know a lot more than we knew then, so I think it's only -- we're only in a better position.
Operator
There are no further questions at this time. And I would like to turn the floor back over to Dr. Mike Rosol for any closing comments.
Michael Stanley Rosol
All right. I think you've heard enough from me today. I want to thank you for joining us today for your engagement and all of your questions. Once again, I want to thank Erika for all her hard work here over the years. And welcome, Joe, here to the fray, at least the public-facing fray. I'm sure he's going to be great and have a fun time. And hopefully, we'll be talking to you, folks, before too long. So thank you, and have a great evening.
Operator
This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a great day.
NEWS -- Navidea Biopharmaceuticals to Host Fourth Quarter 2022 Earnings Conference Call and Business Update
Conference Call to be Held on Tuesday, March 21, 2023 at 5:00 p.m. (EDT)
DUBLIN, Ohio, March 15, 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 it will host a conference call and webcast on Tuesday, March 21, 2023 at 5:00 p.m. (EDT) to discuss corporate developments and financial results for the fourth quarter and full year ended December 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: Fourth Quarter 2022 Earnings Conference Call and Business Update
Date: Tuesday, March 21, 2023
Time: 5:00 p.m. (EDT)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13736745
Webcast Link: https://www.webcast-eqs.com/navidbioph20230321/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 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/20230315005347/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 Key Component of the Company’s Cancer Immunotherapy Pipeline
Targeted therapeutics designed to alter the behavior of macrophages to rally the body’s immune response against tumors
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 from the U.S. Patent and Trademark Office for its patent application titled, “Compositions And Methods For Altering Macrophage Phenotype (US Application #16/832,620).” Broadly, this patent covers the ability of Navidea’s constructs to stimulate the body’s immune response against tumors through targeted delivery of payloads (e.g., doxorubicin, paclitaxel, and bisphosphonates) that change the nature of macrophages to make them more proinflammatory. These constructs have demonstrated the ability to rally an immune response against tumors and make other therapies work more effectively against those tumors in preclinical studies. If confirmed in clinical trials, the ability to increase the efficacy of cancer therapeutics by harnessing the body’s immune system could bring significant benefits to patients.
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. When issued, this patent will protect key elements of Navidea’s cancer immunotherapy product pipeline. Navidea’s cancer immunotherapy product pipeline consists of a series of mannosylated-amine dextrans (“MADs”) that carry small molecule drug payloads that are attached to MADs by degradable linkers. The MADs bind to CD206 receptors on tumor associated macrophages (“TAMs”) and related cells such as dendritic cells and myeloid derived suppressor cells. The degradable linkers are designed to release their small molecule payloads inside the CD206 expressing cells. The small molecule payloads are designed to induce proinflammatory behaviors in these cells.
In tumors, TAMs and their cellular relatives create an immunosuppressive tumor environment that prevents other types of immune cells from attacking cancer cells, thus permitting cancer cells to survive and grow. In addition, this immunosuppressive tumor environment decreases the effectiveness of a wide variety of other cancer therapies, including other cancer immunotherapies. Navidea’s MAD-based cancer immunotherapies alter the behavior of macrophages to make them less immunosuppressive and more proinflammatory, or antitumor. Studies in mouse models of cancer have shown that Navidea’s MAD-based immunotherapies can enhance the effectiveness of other cancer immunotherapies and significantly reduce tumor growth. The results of these studies have been presented at the New York Academy of Sciences (2021), the Tumor Myeloid-Directed Therapies meeting (2022), and at the 2022 annual meeting of the Society for Immunotherapy of Cancer.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, “We are excited about this development that significantly improves our valuable therapeutics intellectual property and strategic partnership potential. This important patent application covers key intellectual property critical to the continued development of our therapeutics pipeline. Our targeted cancer immunotherapeutics have the potential to address the large unmet medical need in oncology, improve the lives of a great number of individuals, and bring significant value to Navidea’s shareholders.”
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/20230103005192/en/
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Files Appeal in CRG Case
DUBLIN, Ohio, December 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 that on November 29, 2022, Navidea and its majority-owned subsidiary Macrophage Therapeutics, Inc. filed an appeal of the judgment by the District Court of Harris County, Texas in Case No. 2018-24442-151; Capital Royalty Partners II, L.P. et al. v. Navidea Biopharmaceuticals, Inc. and Macrophage Therapeutics, Inc., with the 14th Court of Appeals of Texas for review by the appellate court.
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/20221130006173/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Announces 50th Participant Enrolled in the Company’s Phase 3 Trial in Rheumatoid Arthritis
DUBLIN, Ohio, November 28, 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 enrollment of the 50th participant in the Company’s 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)" (ClinicalTrials.gov Identifier: NCT05246280).
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, addressing a large unmet medical need. Overall trial size will range from 198-672 patients, with enrollment targeted to achieve a minimum of 100 clinical responders to anti-TNFa therapy and 98 non-responders.
Rheumatoid arthritis is a serious and potentially debilitating disease. The standard practice of treating RA is to monitor patients starting 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. 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. Additionally, in patients with a low-macrophage type of RA who have been shown to be less responsive to anti-TNFa therapy, an initial baseline scan alone could point their physicians to another therapy type that has a better chance of success than an anti-TNFa.
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 trial 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, with an overall accuracy of early treatment response prediction of 90% at 12-week follow up and 86% at 24 weeks.
The design of the Phase 3 trial is built upon data from this completed Phase 2B study, as well as input from the End of Phase 2 Type B meeting with the FDA. The NAV3-33 Phase 3 trial involves Tc99m tilmanocept imaging in participants with RA who are about to begin anti-TNFa therapy. Planar (two-dimensional) images of the hands and wrists are taken at baseline prior to initiation of therapy and at week 5 following start of therapy. These images are 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, Chief Medical Officer for Navidea, said, "This is an important milestone in our RA program and for the Company as a whole. Throughout this program’s development, we have worked closely with expert rheumatologists, nuclear medicine specialists, and the FDA, and we are confident we are on the right path to bringing a valuable tool forward 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 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. We continue to be excited about the level of progress we are making with this trial, the benefits that it could provide to those suffering from RA, and the value a successfully completed trial would create for our shareholders."
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/20221128005198/en/
Contacts
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
NEWS -- Navidea Biopharmaceuticals Reports Third Quarter 2022 Financial Results
Conference Call to be held Tuesday, November 15, 2022 at 5:00 pm (EST)
DUBLIN, Ohio, November 14, 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 three-month and nine-month periods ended September 30, 2022.
View full version Oress Release on businesswire.com: https://www.businesswire.com/news/home/20221114005449/en/
NEWS -- Navidea Biopharmaceuticals Announces Details of Presentation at Upcoming Society for Immunotherapy of Cancer Annual Meeting
DUBLIN, Ohio, November 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 details of the results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform. The results will be presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer ("SITC") to be held at the Boston Convention & Exhibition Center in person and virtually November 8-12, 2022 in Boston, MA. These details were embargoed by SITC until the week of the meeting.
The abstract, "Synthetic CD206 Targeted Constructs Carrying Paclitaxel or Novel Bisphosphonate Payloads Alter Macrophages Towards Pro-inflammatory Phenotypes; The Paclitaxel Construct Improves the Efficacy of anti-CTLA4 in CT26 Tumors" (Abstract #1161), will be presented as a poster on November 10, 9 am to 9 pm in the conference center’s poster hall.
In this study, results demonstrate that Navidea’s macrophage-targeting Manocept platform technology, consisting of mannosylated amine dextrans ("MAD") and carrying the therapeutic payloads paclitaxel or a novel bisphosponate, could drive the phenotype of macrophages in vitro towards a proinflammatory type (more CD80 and CD86 expression, less CD206 and CD163 expression). This is important because in tumors there exist tumor-associated macrophages ("TAMs") that are typically of the wound healing, anti-inflammatory type, and these play a key role in paradoxically shielding the tumors from the body’s immune response. Driving the TAM phenotype more towards a proinflammatory state should enable both an immune response against the tumors as well as increase the efficacy of other therapies that can work alongside the body’s immune system against the tumors.
In addition to the in vitro work using both the paclitaxel and bisphosphonate carrying constructs, in vivo studies using the MAD-paclitaxel construct in a mouse tumor model demonstrated that this construct increased the efficacy of an approved checkpoint inhibitor therapy, anti-CTLA4, reducing tumor growth by 76% compared to a saline control. Delivery of paclitaxel and bisphosphonates by this method also reduces off-target exposure and should limit toxicity.
Future studies will examine the effect of the MAD-bisphosphonate therapy with and without anti-CTLA4 therapy in the mouse tumor model. Preclinical toxicity studies will also be conducted en route to an Investigational New Drug ("IND") application.
Abstract title and session information can be found on the SITC Annual Meeting website at: https://www.sitcancer.org/2022/home.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these important preclinical results at this internationally recognized meeting. These results provide support for the hypothesis that our macrophage-targeted constructs can increase the efficacy of already approved therapies to significant effect, helping to rally the body’s immune response against tumors." Dr. Rosol continued, "We continue to develop the Manocept platform, using its potent ability to target macrophages, for the development of new immunotherapies for diseases 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 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/20221107005987/en/
Contacts
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 2022 Earnings Conference Call and Business Update
Conference Call to be Held on Tuesday, November 15, 2022 at 5:00 p.m. (EST)
DUBLIN, Ohio, November 04, 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 Tuesday, November 15, 2022 at 5:00 p.m. (EST) to discuss corporate developments and financial results for the third quarter ended September 30, 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: Third Quarter 2022 Earnings Conference Call and Business Update
Date: Tuesday, November 15, 2022
Time: 5:00 p.m. (EST)
U.S. & Canada Dial-In: 877-407-0312
International Dial-In: +1 201-389-0899
Conference ID: 13733801
Webcast Link: https://www.webcast-eqs.com/navidbioph20221115/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/20221104005152/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 Upcoming Society for Immunotherapy of Cancer Annual Meeting
DUBLIN, Ohio, October 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 results from the Company’s ongoing preclinical studies evaluating targeted immunotherapy for cancer based on the Manocept platform have been accepted for presentation at the 37th Annual Meeting of the Society for Immunotherapy of Cancer ("SITC") to be held at the Boston Convention & Exhibition Center in person and virtually November 8-12, 2022 in Boston, MA.
The abstract, "Synthetic CD206 Targeted Constructs Carrying Paclitaxel or Novel Bisphosphonate Payloads Alter Macrophages Towards Pro-inflammatory Phenotypes; The Paclitaxel Construct Improves the Efficacy of anti-CTLA4 in CT26 Tumors" (Abstract #1161), will be presented as a poster on November 10, 9 am to 9 pm in the conference center’s poster hall. Further details of the abstract will be announced in a future press release once the meeting embargo is lifted.
Abstract title and session information can be found on the SITC Annual Meeting website at: https://www.sitcancer.org/2022/home.
Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these important preclinical results at this internationally recognized meeting." Dr. Rosol continued, "We continue to develop the Manocept platform, using its potent ability to target macrophages, for the development of new immunotherapies for diseases 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 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/20221005005778/en/
Contacts
Investor Relations Contact
Navidea Biopharmaceuticals, Inc.
Jeffrey Smith
Vice President of Operations
614-822-2365
mailto://jsmith@navidea.com
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