Navidea Biopharmaceuticals, Inc.

WARRINGTON, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced changes to its board of directors, effective August 13, 2024, which include the appointment of Saundra Pelletier and Jed Latkin as two new independent directors with significant public company director and executive leadership. Joining the Windtree board is Saundra Pelletier, who has served as the Interim Chair since late 2021 and as Chief Executive Officer, President and Executive Director since early 2015 of Evofem Biosciences, Inc., a commercial-stage biopharmaceutical company focused on commercializing innovative products to address unmet needs in women's health. Ms. Pelletier brings more than twenty-five years of broad executive leadership experience to Windtree’s board, including successes in driving multiple, billion-dollar product launches, expanding organizational capabilities in ex-U.S. markets and advocating for women's health. Throughout her career, she has had oversight and accountability for nearly all aspects of commercialization, manufacturing and medical and business development. Saundra has also served on the board of directors for TRACON Pharmaceuticals, Inc., since early 2020, which is focused on developing novel oncology therapeutics. We believe Saundra has significant drug development and licensing and deal experience to add to Windtree’s board. Also adding to Windtree’s board is Jed Latkin, who has nearly three decades of experience with financial and biotech companies. Jed’s experience includes serving as the Chief Operating Officer and head of Finance for ProPhase Labs, Inc. since January 2023, and as the Chief Executive Officer of Navidea Biopharmaceuticals, Inc., where he raised over $160 million and arranged a key transaction for Navidea that resulted in consideration up to $310 million. While at Navidea, he also served as the Chief Financial Officer prior to becoming the Chief Executive Officer. In connection with his role at Nagel Avenue Capital, he also served as Chief Executive Officer of Black Elk Energy Offshore in 2014. Jed started his career by spending ten years on Wall Street with a variety of investment banking organizations and funds including ING, Morgan Stanley and Citigroup Securities. Saundra and Jed’s additions to Windtree’s board fill the opening of roles from the resignation of Daniel Geffken and Leslie Williams from Windtree’s board, also effective August 13, 2024. Neither decision to resign was the result of any disagreement with the Company on any matter relating to its operations, policies or practices and the Company greatly appreciates Dan and Leslie’s many years of service to Windtree. As part of these changes, the Company also announced Mark Strobeck, who joined the board in 2023, has become the Lead Independent Director of Windtree’s board, effective August 13, 2024. Craig Fraser, Chairman and CEO of Windtree said, “This is an exciting time for Windtree, and it is easy to focus on the day to day progress that has set up an eventful next several months and quarters– particularly with the planned release of important Phase 2b clinical trial results. However, looking to the mid to long term, with the acquisition of the novel oncology preclinical aPKCi platform and with the expectation that our cardiovascular lead asset of istaroxime will enter into a planned Phase 3, there will be key strategic decisions to make regarding potential deals and partnerships and optimal portfolio focus. We believe Saundra and Jed have the specific experience to help us navigate these opportunities and shape our execution.” About Windtree Therapeutics, Inc.Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase II candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information:Eric Curtisecurtis@windtreetx.com

Navidea Biopharmaceuticals, Inc. has completed an exploratory analysis of its Rheumatoid Arthritis Program COLUMBUS, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (OTC: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced disappointing results of an exploratory analysis conducted on the Company’s pivotal NAV3-33 clinical trial titled “Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis (RA)” (ClinicalTrials.gov Identifier: NCT05246280) the “RA Trial.” The purpose of the exploratory analysis was to optimize the diagnostic performance in support of the methodologies to be applied in the final pivotal trial. The results confirm that intravenous Tc 99m tilmanocept can target and produce reliable images of macrophage activity in RA patients, but that these images do not adequately predict which patients will respond to treatment with an anti-TNF alpha medication. "We were very surprised and disappointed that the results of the exploratory analysis did not support the hypothesis of an overall accuracy of early treatment response approaching 90%, but rather, the overall accuracy of early treatment response was on average consistently below 70%,” said Dr. Michael Blue, Navidea’s Chief Medical Officer. "Results with that predictive value are not indicative of a commercially viable product.” Given these results, Navidea is suspending all activities related to the RA Trial. The Company is pivoting to focus on exploring all opportunities related to the Company’s therapeutic assets. About Navidea Navidea Biopharmaceuticals, Inc. (OTC: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit . 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 or at . 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: Contacts Investor Relations Navidea Biopharmaceuticals, Inc. Craig A. Dais, Chief Financial Officer cdais@navidea.com (614)-822-2322 Source: Navidea Biopharmaceuticals, Inc. View this news release online at:

Navidea Biopharmaceucitals, Inc. will present two proposals for vote in a virtual special meeting of shareholders to be held on July 8, 2024 COLUMBUS, Ohio--(BUSINESS WIRE)-- Navidea Biopharmaceuticals, Inc. (OTC: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced it will be hosting a virtual meeting of its stockholders at 1pm ET on Monday, July 8th, 2024. The purpose of the special meeting is to consider and vote upon (i) an amendment to the Company’s certificate of incorporation to allow stockholders to act by written consent, and (ii) an amendment to the Company’s certificate of incorporation to implement a reverse stock split of the Company’s common stock at a ratio of up to 1-for-50,000 shares. The decision of whether to complete a reverse stock split and the ratio at which it would be completed will be determined at the discretion of the Company’s Board of Directors. "As we continue to pursue strategic partnerships or other opportunities to fund the Company’s ongoing clinical trial activities in Rheumatoid Arthritis, the option of a written consent will allow the Company to act in a timely manner,” said Craig A. Dais, Navidea’s Chief Financial Officer. “In addition, as a measure to reduce costs and extend our cash runway, we want ensure the number of record holders of the Company’s common stock is below the SEC threshold, to avoid public reporting requirements.” The reverse stock split, if implemented, would result in lowering the number of record holders. Changes to the Board of Directors Board of Directors, Dana J. Moss, Jill Bieker Stefanelli, and Joshua Wilson resigned their positions on the Company’s board of directors effective May 7, 2024. Related to this change, Navidea and G2G Ventures, LLC (“G2G Ventures”), for whom Mr. Wilson is the Executive Director, terminated G2G Venture’s Executive Consulting agreement with the Company. "We are extremely grateful for the contributions of these three directors over the last several months,” John K. Scott, Jr, Navidea’s Vice Chair of the Board. “We are also fortunate to have had the executive leadership of Dr. Jason Myers and his team at G2G Ventures for the last year. Going forward, we feel we are well positioned with our remaining management team, a total of eight employees, to continue to move the Company forward.” About Navidea Navidea Biopharmaceuticals, Inc. (OTC: NAVB) is a biopharmaceutical company focused on the development of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on its Manocept platform to enhance patient care by identifying the sites and pathways of disease and enable better diagnostic accuracy, clinical decision-making, and targeted treatment. Navidea’s Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, visit . 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 or at . 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: View source version on businesswire.com: Contacts Investor Relations Contact Navidea Biopharmaceuticals, Inc. Craig A. Dais, Chief Financial Officer cdais@navidea.com (614)-822-2322 Source: Navidea Biopharmaceuticals, Inc. View this news release online at: