false
0000946486
0000946486
2025-08-04
2025-08-04
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): August 4, 2025
Windtree Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
|
Delaware
|
001-39290
|
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. ☐
Windtree Therapeutics, Inc. (the “Company”) has terminated its 04-CL-2201 (SEISMiC-C) clinical study, A Multcenter, Randomized, Placebo- Controlled, Parallel Group Trial on the Safety and Efficacy of Istaxime for Cardiogenic SCAI Stage C (SEISMiC-C) (the “Study”), at 20 enrollments. The Company’s decision to terminate the Study is related to the Company’s limited resources and its desire to advance the development of istaroxime into the broader acute hear failure space, and was not a result of any safety concerns with the Study.
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.
|
Windtree Therapeutics, Inc.
|
|
| |
|
|
|
By:
|
/s/ Jed Latkin
|
|
|
Name:
|
Jed Latkin
|
|
|
Title:
|
President and Chief Executive Officer
|
|
Date: August 8, 2025
