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EX-99.1 - EXHIBIT 99.1 - WINDTREE THERAPEUTICS INC /DE/ex_205369.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): September 29, 2020

 

Windtree Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

         

Delaware

 

000-26422

 

94-3171943

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

     

2600 Kelly Road, Suite 100, Warrington, Pennsylvania

 

18976

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (215) 488-9300

 

Not Applicable

(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))

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.001 per share

 

WINT

 

The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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 8.01

Other Events.

 

On September 29, 2020, Windtree Therapeutics, Inc. (the “Company”) issued a press release announcing that the United States Food and Drug Administration has accepted the Company’s Investigational New Drug application for a Phase 2 clinical trial studying lyo lucinactant, its KL4 surfactant drug, in COVID-19 associated lung injury and acute respiratory distress syndrome patients. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01

Financial Statements and Exhibits.

 

 (d) Exhibits

 

The following exhibits are being filed herewith:

 

Exhibit
No.

 

Document

 

 

 

99.1

 

Press Release of Windtree Therapeutics, Inc., dated September 29, 2020.

 

 

 

SIGNATURES

 

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

 

 

   

Windtree Therapeutics, Inc.

     
 

By:

/s/ Craig E. Fraser

 

Name:

Craig E. Fraser

 

Title:

President and Chief Executive Officer

 

 

Date: September 29, 2020