[8-K] Windtree Therapeutics, Inc. Reports Material Event

Rhea-AI Filing Summary

Windtree Therapeutics has stopped the SEISMiC-C clinical study of istaroxime after 20 enrollments. The company said the decision reflects limited resources and a strategic choice to prioritize developing istaroxime for a broader acute heart failure population. The filing explicitly states the termination was not due to safety concerns, indicating the halt is a portfolio and resource decision rather than an adverse safety finding. This action will pause data collection from the terminated cohort and shift development focus toward larger acute heart failure opportunities.

Positive

• Termination stated as not safety-related, preserving program reputation
• Strategic refocus on broader acute heart failure could target a larger market opportunity

Negative

• Study terminated at 20 enrollments, halting data collection and reducing near-term clinical data flow
• Limited resources cited, implying potential funding or prioritization constraints that may delay development

Insights

Clinical Development Lead

Trial halted for strategic resource reallocation; no safety signal reported.

The company terminated the SEISMiC-C study after 20 enrollments to concentrate development of istaroxime in a broader acute heart failure setting. Stopping a small trial at 20 patients typically means the sponsor will stop collecting additional efficacy or safety data from that cohort and reallocate clinical operations resources.

Risks include loss of the specific dataset the study would have produced and potential timeline delays for regulatory or development milestones tied to the program. Watch for announcements about redesigned protocols, new trial starts in the broader acute heart failure indication, or updated resource plans.

Corporate Finance Analyst

Resource constraints drove the termination; expect near-term R&D reprioritization.

Terminating at 20 enrollments is a cost-containment and strategic decision; it may conserve cash short-term but could delay value-creating milestones tied to the SEISMiC-C dataset. The firm explicitly linked the move to limited resources and a strategic refocus rather than safety issues.

Investors should monitor updated R&D budgets, any financing activity to support broader acute heart failure trials, and timelines for new study initiations that would indicate how quickly the company will redeploy resources.

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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. ☐

Item 8.01 Other Events

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

FAQ

What did Windtree Therapeutics (WINT) announce about the SEISMiC-C study?

The company announced it has terminated the SEISMiC-C study after 20 enrollments, stating the decision was due to limited resources and a desire to focus istaroxime development on broader acute heart failure.

Was the SEISMiC-C study termination related to safety concerns?

No. The company explicitly said the termination was not a result of any safety concerns with the study.

How many patients were enrolled before the SEISMiC-C study was stopped?

The study was terminated after 20 enrollments.

What reason did Windtree give for stopping the SEISMiC-C trial?

Windtree cited limited resources and a strategic decision to advance istaroxime into the broader acute heart failure space.

Will the termination delay Windtree's istaroxime program?

The filing indicates a shift in focus that may pause data collection from this study; the company did not provide a timeline for next steps or new trials.