# EDGAR Filing Document

**Accession Number:** 0000946486
**File Stem:** 0001437749-25-024720
**Filing Date:** 2025-8
**Character Count:** 13802
**Document Hash:** a3197ed4e5a74a4a24658a4e15ea322b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-024720.hdr.sgml**: 20250805

**ACCESSION NUMBER**: 0001437749-25-024720

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250805

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250805

**DATE AS OF CHANGE**: 20250805

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** WINDTREE THERAPEUTICS INC /DE/
- **CENTRAL INDEX KEY:** 0000946486
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 943171943
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39290
- **FILM NUMBER:** 251183149

**BUSINESS ADDRESS:**
- **STREET 1:** 2600 KELLY ROAD
- **STREET 2:** SUITE 100
- **CITY:** WARRINGTON
- **STATE:** PA
- **ZIP:** 18976
- **BUSINESS PHONE:** 2154889300

**MAIL ADDRESS:**
- **STREET 1:** 2600 KELLY ROAD
- **STREET 2:** SUITE 100
- **CITY:** WARRINGTON
- **STATE:** PA
- **ZIP:** 18976

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** DISCOVERY LABORATORIES INC /DE/
- **DATE OF NAME CHANGE:** 19971201

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ANSAN PHARMACEUTICALS INC
- **DATE OF NAME CHANGE:** 19961121

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ANSAN INC
- **DATE OF NAME CHANGE:** 19950609

?xml version='1.0' encoding='ASCII'? wint20250805_8k.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): August 5, 2025**

## Windtree Therapeutics, Inc.
**(Exact name of registrant as specified in its charter)** 

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| | | |
|:---|:---|:---|
| **Delaware** | **001-39290** | **94-3171943** |
| **(State or other jurisdiction of**<br> **incorporation or organization)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange**<br> **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. ☐

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**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:

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| | |
|:---|:---|
| **Exhibit**<br> **No.** | **Document** |
| 99.1 | [Press release dated August 5, 2025](ex_848198.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

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**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. | Windtree Therapeutics, Inc. |
| By: | /s/ Jed Latkin |
| Name: | Jed Latkin |
| Title: | President and Chief Executive Officer |

---

Date: August 5, 2025

## Exhibit 99.1

**Exhibit 99.1**

**Windtree Announces Istaroxime Phase 2 Interim Analysis in SCAI Stage C Cardiogenic Shock Patients**

*Istaroxime was added to currently available inotropes and vasopressors in the study - no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials*

*Cardiogenic shock is a severe presentation of heart failure and SCAI Stage C patients have low blood pressure and signs of organ damage due to low blood flow* 

*These data provide the Company confidence to move forward with a global Phase 3 trial* 

**WARRINGTON, PA** – **August 5, 2025** – Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners, has performed a planned interim analysis of the SEISMiC C Phase 2 study data evaluating istaroxime in SCAI Stage C cardiogenic shock which showed istaroxime had a similar profile to that seen in previous studies despite a greater severity of illness and being used in addition to currently available inotropes and vasopressors.

The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is placebo-controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors in patients with more severe cardiogenic shock (SCAI stage C) than has been studied previously. The study follows the results of the SEISMIC B study where istaroxime was shown to improve blood pressure and hemodynamic variables such as cardiac output (the amount of blood pumped by the heart per minute), reduced filling pressures in the heart and improved signs of organ perfusion such as mixed venous oxygenation in patients with milder cardiogenic shock (SCAI stage B). This data is contributing to a very unique profile of istaroxime in acute decompensated heart failure across severity of illness. Inotropes and vasopressors agents are given to many patients in intensive care units in the USA every year and the results of the SEISMIC program may suggest potential advantages to istaroxime over existing therapies in efficacy and possibly safety. The SESIMIC C study was designed to assess the effects of istaroxime in patients with SCAI Stage C cardiogenic shock (i.e., more severe cardiogenic shock than patients enrolled in previous acute heart failure and cardiogenic shock studies in the past). Many patients in SESIMIC C were treated at the time of enrollment with vasopressors or inotropes and hence the SESIMIC C study is testing for the first time the safety and efficacy of istaroxime in more severe cardiogenic shock when istaroxime treatment is combined with other therapies for cardiogenic shock.

The interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies.

------

"The results of the SEISMIC C interim analysis are exciting," said Jed Latkin, Chief Executive Officer of Windtree. "We believe these data will be instrumental in moving istaroxime to a global Phase 3 program in heart failure and cardiogenic shock. Steve Simonson, Chief Medical Officer added, "The interim data are consistent with the previous clinical study results seen in patients with AHF and less severe forms of cardiogenic shock. These data are encouraging for the potential of istaroxime to be effective across the spectrum of cardiogenic shock due to AHF with or without other inotropic or vasopressor drugs."

**About Istaroxime**

Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances.

**About Windtree Therapeutics, Inc.**

Windtree Therapeutics, Inc. is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners.

**Forward Looking Statements**

The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. Examples of such risks and uncertainties include, among other things: 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 and other risks are described in the Company's periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events, or otherwise, after the date of this press release.

**Contact Information:**

Eric Curtis

<u>ecurtis@windtreetx.com</u>