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Form 8-K NAVIDEA BIOPHARMACEUTICA For: Nov 21

November 28, 2018 5:18 PM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

Date of Report (Date of earliest event reported)

November 21, 2018

 

 

NAVIDEA BIOPHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

001-35076

31-1080091

(State or other jurisdiction

(Commission

(IRS Employer

of incorporation)

File Number)

Identification No.)

 

4995 Bradenton Avenue, Suite 240, Dublin, Ohio

43017

(Address of principal executive offices)

(Zip Code)

 

Registrant's telephone number, including area code

(614) 793-7500

 

 

 

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Item 5.02.      Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

On November 21, 2018, the Company appointed Kathy Rouan, Ph.D., as a director. Dr. Rouan’s appointment, which will be effective on December 1, 2018, was made to the class with terms expiring at the annual meeting of stockholders to be held in 2019. Dr. Rouan was not appointed to serve on any committees of the Board, although she may be appointed to one or more committees at a later date. On November 26, 2018, the Company issued a press release relating to the appointment of Dr. Rouan, which is filed as Exhibit 99.1 to this report and is incorporated herein by reference.

 

Similar to other non-employee directors, Dr. Rouan will receive compensation for her service as director in accordance with the Company’s non-employee director compensation program.

 

There is no arrangement or understanding between Dr. Rouan and any other person pursuant to which she was selected as a director of the Company and there are no family relationships between Dr. Rouan and any of the Company’s directors or executive officers. There are no transactions to which the Company is a party and in which Dr. Rouan has a direct or indirect material interest that would be required to be disclosed under Item 404(a) of Regulation S-K.

 

In connection with her appointment, Dr. Rouan is expected to enter into a standard Director Agreement with the Company, a form of which was previously filed by the Company with the U.S. Securities and Exchange Commission on May 10, 2016, and which is incorporated by reference herein.

 

Item 9.01.      Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

 

Number

Exhibit Description

 

 

99.1

Press Release dated November 26, 2018.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

NAVIDEA BIOPHARMACEUTICALS, INC.

 

 

 

 

 

 

Date: November 28, 2018

By:

/s/ Jed A. Latkin

 

 

Jed A. Latkin

Chief Executive Officer, Chief Operating Officer and Chief Financial Officer

 

Exhibit 99.1

 

Navidea Biopharmaceuticals Appoints Dr. Kathy Rouan to Board of Directors

 

DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the appointment of Kathy Rouan, PhD, to the Company’s board of directors, effective December 1, 2018.

 

“We are excited for Dr. Rouan to join Navidea’s board of directors at an instrumental time in the Company’s development,” said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. “Dr. Rouan is a distinguished expert in the life sciences industry, bringing almost 30 years of experience in discovery and development roles at GlaxoSmithKline (“GSK”). Her industry knowledge will be a valuable addition to the team as Navidea progresses its Macrophage targeting technology.”

 

“I look forward to helping Navidea advance its important new approach to guide optimal treatment in rheumatoid arthritis,” commented Kathy Rouan, PhD. “This is an exciting time for the Company and I am pleased to join the Board at such a critical juncture.”

 

Dr. Rouan was appointed SVP and Head of Projects, Clinical Platforms and Sciences (“PCPS”) at GSK in May 2016. The PCPS organization within GSK encompasses the Global Clinical Operations, Statistics and Programming, Clinical Pharmacology, GCP Quality, Third Party Resourcing and Project Management functions and includes approximately 1,800 staff in 20 countries. She first joined GSK in 1989 with a background in Pharmaceutical Sciences, focusing on formulation development of protein pharmaceuticals. In 1993, Dr. Rouan moved into Project Leadership and Management becoming VP and Head of Metabolism and Pulmonary Project Management in 1999. She continued to lead Projects in a number of Therapeutic areas including Cardiovascular, Immunoinflammation and Gastroenterology Therapy areas. In 2007, Dr. Rouan led the development, submission and approval of Arzerra (ofatumumab) in refractory chronic lymphocytic leukemia. In 2012, she became Head of Biopharmaceutical Development responsible for delivery of GSK’s portfolio of biopharmaceutical medicines. In December 2013, Dr. Rouan was appointed SVP and Head of R&D Stiefel, GSK’s Dermatology therapy area unit. Dr. Rouan holds a PhD in Pharmaceutical Sciences from the University of Rhode Island, and a B.Pharm. from the University of London.

 

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. The development activities of the Manocept immunotherapeutic platform are being conducted by Navidea in conjunction with its subsidiary, Macrophage Therapeutics, Inc. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s pipeline through global partnering and commercialization efforts.

 

For more information, please visit www.navidea.com.

 

 

 

 

Forward-Looking Statements

This release and any oral statements made with respect to the information contained in this 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. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: any future actions by Platinum-Montaur; general economic and business conditions, both nationally and in our markets; our history of losses and uncertainty of future profitability; the final outcome of the CRG litigation in Texas and Ohio; 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 expectations and estimates concerning future financial performance, financing plans and the impact of competition; our ability to raise capital sufficient to fund our development and commercialization programs; our ability to implement our growth strategy; anticipated trends in our business; advances in technologies; our ability to comply with the NYSE American continued listing standards; and other risk factors detailed in our most recent Annual Report on Form 10-K and other SEC filings. You are urged to carefully review and consider the disclosures found in our SEC filings, which are available at www.sec.gov or at http://ir.navidea.com.

 

Investors are urged to consider statements that include the words “will,” “may,” “could,” “should,” “plan,” “continue,” “designed,” “goal,” “forecast,” “future,” “believe,” “intend,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions, as well as the negatives of those words or other comparable words, to be uncertain forward-looking statements.

 

You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be incorrect. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.

 

Contacts:

Navidea Biopharmaceuticals, Inc.
Jed Latkin, CEO, 614-973-7490
[email protected]

 

Or

 

Edison Advisors
Joseph Green, 646-653-7030
[email protected]

 

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