WINT files 8-K on interim SEISMiC-C Phase 2 data; no financials

(High)

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

On 5 Aug 2025, Windtree Therapeutics (Nasdaq: WINT) filed a Form 8-K under Item 7.01 to furnish a press release (Exhibit 99.1) reporting interim data from the SEISMiC-C Phase 2 study of its lead cardiac candidate, istaroxime. The document contains no financial figures or detailed clinical results; it simply notifies investors that the data have been announced via press release and will not be treated as "filed" for Exchange Act liability. Management states that positive outcomes could enable a global Phase 3 program, but also cites customary forward-looking risk factors covering clinical success, cost management and operational execution. No other material transactions, financial statements or exhibits were included beyond the press release and Inline XBRL cover page.

Positive

Pipeline momentum: Furnishing of interim Phase 2 SEISMiC-C data indicates the istaroxime program is advancing toward potential Phase 3 evaluation.

Negative

None.

Insights

TL;DR: Pipeline update only; no data disclosed, so market impact neutral until details emerge.

The 8-K merely furnishes a press release about interim SEISMiC-C Phase 2 data. Without efficacy or safety metrics, investors cannot gauge clinical success or commercial potential. Management’s reference to a possible Phase 3 launch signals continued development momentum, but the lack of quantitative outcomes limits valuation impact. Forward-looking statements remind investors of trial, funding and regulatory risks. I view the disclosure as routine and informational rather than a catalyst.

TL;DR: Filing adds no new risk; standard Reg FD communication, impact minimal.

The company complies with Reg FD by publicising interim study news. Because the 8-K does not amend guidance, report adverse events, or introduce financial obligations, balance-sheet and regulatory risk profiles remain unchanged. Materiality hinges on the yet-unseen study data; therefore I classify the current disclosure as low impact.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Windtree Therapeutics (WINT) announce in its 8-K dated August 5, 2025?

The company furnished a press release containing interim data from the SEISMiC-C Phase 2 study of istaroxime.

Did the 8-K include any financial results or guidance for WINT?

No. The filing contained no financial statements, revenue figures, or updated guidance.

Is the interim SEISMiC-C data considered "filed" with the SEC?

No. Under Item 7.01, the information is furnished, not filed, and is therefore not subject to Section 18 liabilities.

Could the SEISMiC-C results lead to a Phase 3 trial for istaroxime?

Management indicated that successful Phase 2 outcomes could support a global Phase 3 program, but no decision has been announced.

Were any other exhibits included besides the press release?

Only Exhibit 99.1 (press release) and 104 (Inline XBRL cover page) accompanied the filing.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/05/2025 - 09:05 AM

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 5, 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:

☐	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 7.01 Regulation FD Disclosure.

On August 5, 2025, Windtree Therapeutics, Inc. (the “Company”) issued a press release announcing its interim data of the SEISMiC C Phase 2 study. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information contained in this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section and shall not be deemed to be incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Cautionary Language Concerning Forward-Looking Statements.

This Current Report on Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 with respect to the term sheets and other related matters. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are based upon the Company’s and its management’s current expectations, assumptions, estimates, projections and beliefs. Such statements include, but are not limited to, statements regarding the success of the SEISMiC C Study, the ability to move istaroxime to a global Phase 3 program and risks related to the Company’s ability to manage costs and execute on its operational and budget plans. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in, or implied by, these forward-looking statements. Other risks relating to the Company’s business, including risks that could cause results to differ materially from those projected in the forward-looking statements in this Current Report, the Company’s latest Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and/or Current Reports on Form 8-K filings with the United States Securities and Exchange Commission, especially under the heading “Risk Factors.” The forward-looking statements in this Current Report speak only as of this date, and the Company disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits

The following exhibits are being filed herewith:

Exhibit No.		Document
99.1		Press release dated August 5, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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 5, 2025

Source: View Original Filing on SEC EDGAR

WINT files 8-K on interim SEISMiC-C Phase 2 data; no financials