8-K

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

April 24, 2019

Date of Report (Date of earliest event reported)

Windtree Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	000-26422	94-3171943
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification Number)

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

(Address of principal executive offices)

(215) 488-9300

(Registrant's telephone number, including area code)

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:

☐ 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 April 24, 2019, the board of directors (the “Board”) of Windtree Therapeutics, Inc. (the “Company”) appointed Daniel Geffken to be a director of the Company. Mr. Geffken was also appointed chairman of the audit committee of the Board and member of the compensation committee of the Board.

Since 2011, Mr. Geffken has been serving as the Founding Managing Partner of Danforth Advisors, a leading financial and strategy consulting firm to the life sciences industry. He has served as chief financial officer and strategic consultant to numerous companies, including Apellis Pharmaceuticals, Cidara Therapeutics, Cabaletta Bio, Homology Medicines, Stealth BioTherapeutics and Transkaryotic Therapies. Mr. Geffken has served on the board of directors of Elicio Bio, Alcobra Ltd. and Arcturus Inc., after its merger with Alcobra. Since 2013, he has assisted in ten initial public offering filings. Over the course of his career, he has assisted in raising more than $1 billion in equity and debt securities for life science companies.

Item 8.01 Other Events.

On April 30, 2019, the Company issued a press release announcing the appointment of Mr. Geffken to the Board. A copy of that press release is attached to this Report as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Exhibit Description
99.1	Press Release of Windtree Therapeutics, Inc., dated April 30, 2019.

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 thereunto duly authorized.

Date: April 30, 2019 Windtree Therapeutics, Inc. By: /s/ Craig Fraser Craig Fraser President and Chief Executive Officer

EX-99.1

Exhibit 99.1

 

Windtree Therapeutics Appoints Daniel Geffken to Board of Directors

WARRINGTON, PA — April 30, 2019 — Windtree Therapeutics, Inc. (OTCQB: WINT), a biopharmaceutical and medical device company focused on developing novel therapies to address significant unmet needs in important acute care markets, today announced it has appointed Daniel Geffken to the Company’s Board of Directors, effective April 24, 2019.

“As we continue to support Windtree in the delivery of near-term and sustainable growth, it is with great pleasure that we welcome Daniel to our Board,” said James Huang, Windtree’s Chairman of the Board. “Daniel’s track record of success spans many decades. He brings to Windtree a deep understanding of our industry and corporate financial management, and his overall business acumen, insights and expertise will support Windtree’s efforts to build on its current momentum and create value in the future.”

Since 2011, Mr. Geffken has been serving as the Founding Managing Partner of Danforth Advisors, a leading financial and strategy consulting firm to the life sciences industry. He has served as chief financial officer and strategic consultant to numerous companies, including Apellis Pharmaceuticals, Cidara Therapeutics, Cabaletta Bio, Homology Medicines, Stealth BioTherapeutics and Transkaryotic Therapies. Mr. Geffken has served on the Board of Directors of Elicio Bio, Alcobra Ltd. and Arcturus Inc., after its merger with Alcobra. Since 2013, he has assisted in ten initial public offering filings. Over the course of his career, he has assisted in raising more than $1 billion in equity and debt securities for life science companies.

“I am pleased to join a great team of directors on Windtree’s board, especially during this transformational time for the Company,” said Mr. Geffken. “Windtree’s recent merger with CVie Therapeutics has given the Company a global presence and a larger therapeutic footprint than in the past. This translates into more avenues for growth and value generation and, for me, an exciting opportunity to contribute to their success.”

Mr. Geffken will serve as Chairman of the Board’s Audit Committee and as a member of the Compensation Committee.

About Windtree Therapeutics

Windtree Therapeutics, Inc. is a clinical-stage, biopharmaceutical and medical device company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Windtree has four lead development programs and multiple pre-clinical programs spanning respiratory and cardiovascular disease states, including AEROSURF®, an innovative combination drug/device product candidate that is designed to deliver the Company’s proprietary synthetic, peptide-containing surfactant non-invasively to premature infants with respiratory distress syndrome (RDS); istaroxime, a novel, dual-acting agent being developed to improve cardiac function in patients with acute heart failure while avoiding the unwanted side effects of existing treatments; and rostafuroxin, a novel precision drug product being developed to target hypertensive patients with certain genetic profiles in the important group of patients with resistant hypertension. Windtree also has multiple pre-clinical products including potential heart failure therapies delivered orally that are based on SERCA2a mechanism of action.

For more information, please visit the Company's website at www.windtreetx.com.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.  Examples of such risks and uncertainties include those risks related to the post-merger integration of CVie Therapeutics Limited, including with respect to having two international locations; risks related to Windtree’s ability to secure significant additional capital as and when needed, if at all; Windtree's product development programs, which are expected to involve time-consuming and expensive clinical trials that may be subject to potentially significant delays or regulatory holds, or fail; risks related to development of Windtree’s aerosol delivery systems (ADS) and related components; risks related to the manufacture by contract manufacturers or suppliers of drug products, drug substances, ADS and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including those of the U.S. Food and Drug Administration or other regulatory authorities that 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 Windtree's products; and other risks and uncertainties described in Windtree's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.

Contact Information:

John Tattory

Senior Vice President and Chief Financial Officer

215.488.9418 or jtattory@windtreetx.com