Windtree Therapeutics, Inc. is a biotechnology company developing therapies for critical conditions, primarily cardiovascular and oncology indications, with a focus on acute heart failure and related diseases.

# Company Summary: Windtree Therapeutics, Inc.

## Overview
- **Industry:** Biotechnology
- **Focus:** Developing therapies for critical conditions and diseases, primarily cardiovascular and oncology indications.
- **Business Model:** In-licensed products, clinical development, and a partnership/licensing strategy to generate revenue.

## Key Products & Development Pipeline
- **Lead Product Candidate: Istaroxime**
  - **Type:** First-in-class, dual-mechanism agent
  - **Indications:** Acute heart failure (AHF) and cardiogenic shock
  - **Status:** Phase 2 clinical trials completed; positive topline results from multiple studies (including SEISMiC and SEISMiC Extension)
  - **Mechanism:** Inhibits sodium-potassium ATPase and activates SERCA2a, improving cardiac contractility and relaxation
  - **Designations:** FDA Fast Track for AHF
  - **Markets:** Emergency and hospital settings; large addressable market (~$1.25 billion globally for cardiogenic shock)

- **Other Cardiovascular Programs:**
  - **SERCA2a Activators:** Preclinical compounds with potential for chronic and acute heart failure
  - **Rostafuroxin:** For hypertension with a specific genetic profile (~20-25% of hypertensive population); demonstrated efficacy in Phase 2, but development delayed due to funding issues

- **Oncology Program:**
  - **aPKCi Inhibitor:** For cutaneous malignancies (e.g., basal cell carcinoma) and solid tumors
  - **Status:** Preclinical; developing topical and oral formulations
  - **Patents:** Covered by multiple patents expiring between 2033-2040
  
- **Other Assets:**
  - **KL4 Surfactant Products:** For respiratory conditions like RDS, BPD, ARDS, cystic fibrosis
  - **Technology:** Aerosol delivery systems, with patents protecting core components
  
## Business Strategy
- Transitioning to a revenue-generating biotech via acquisitions of small companies, their FDA-approved products, and partnerships.
- Focus on areas with unmet medical needs in acute and critical care, cardiology, and oncology.
- Explore licensing, research collaborations, and eventual commercialization of product candidates.

## Operational & Financial Details
- **Employees:** 14 full-time employees as of April 15, 2025 (primarily in the U.S.)
- **Number of Shares Outstanding:** 3,555,953 as of April 15, 2025
- **Market Capitalization:** Approximately $1.9 million as of June 28, 2024 (based on Nasdaq closing price)
- **Revenue & Income:** Not disclosed; the company is in clinical-stage development and has incurred operational losses
- **Recent Financial Activity:** 
  - Sold equity and warrants; net proceeds from recent financings approximate $1.5 million and $0.6 million
  - Borrowed around $312,500 in secured notes
  - Total cash and cash equivalents: ~$1.8 million as of December 31, 2024
  
## Summary
Windtree Therapeutics is a biotech firm primarily engaged in developing innovative therapies for heart failure and related cardiovascular conditions, with a focus on acute treatment options such as istaroxime. The company also has oncology assets and respiratory product candidates. It is in the clinical-stage, operating at a loss, with a small team and limited current liquidity, and is pursuing strategic acquisitions and licensing to grow and become revenue-generating.

Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for acute heart failure and oncology.

# Company Overview - Windtree Therapeutics

## Business Model
Windtree Therapeutics is a biotechnology company focused on developing innovative therapies for critical conditions and diseases. Their primary areas of research are cardiovascular diseases, particularly acute heart failure (AHF) and cardiogenic shock, as well as oncology.

## Product Candidates
1. **Istaroxime**: 
   - **Stage**: Phase 2 Clinical Trials.
   - **Indications**: 
     - Treatment of acute heart failure (AHF).
     - Management of early cardiogenic shock (SCAI Stage B).
   - **Mechanism**: A first-in-class, dual-action drug that improves cardiac function and increases blood pressure.
   - **Clinical Trials**: 
     - Positive topline results announced in April 2022 for AHF.
     - SEISMiC Extension study initiated in Q4 2023 to enroll up to 30 subjects.
     - SEISMiC C study initiated in Q4 2023 for SCAI Stage C cardiogenic shock, targeting 20 subjects.
   - **Market Opportunity**: Estimated total addressable market for cardiogenic shock is $1.25 billion.

2. **Rostafuroxin**: 
   - **Stage**: Phase 2 Clinical Trials.
   - **Indications**: Treatment of hypertension in patients with specific genetic profiles.
   - **Business Strategy**: Actively pursuing licensing arrangements for further development.

3. **SERCA2a Activators**: 
   - **Stage**: Preclinical.
   - **Indications**: Potentially for treatment in both acute decompensated and chronic outpatient heart failure.
   - **Research**: Includes follow-on oral and intravenous compounds.

4. **aPKCi Inhibitor**: 
   - **Stage**: Preclinical.
   - **Indications**: Investigated for use in various oncology indications (e.g., basal cell carcinoma, non-small cell lung cancer).
   - **Potential Applications**: Topical and oral formulations are being developed.

## Collaborations and Partnerships
- **Lee’s Pharmaceutical (HK) Ltd.**: Licensed rights for istaroxime, rostafuroxin, and SERCA2a activators for development and commercialization in Greater China.
- **Varian Biopharmaceuticals Agreement**: Asset purchase agreement in April 2024 for proprietary aPKCi inhibitor with plans for IND-enabling activities.

## Financial Information
- **Employees**: As of April 2024, Windtree has 15 full-time employees.
- **Revenue**: Specific revenue figures are not provided in the summary but the company anticipates generating substantial revenues from successful product approvals and commercialization.
- **Income**: Operating losses reported as follows: 
  - $20.6 million for the year ended December 31, 2023.
  - $41.3 million for the year ended December 31, 2022.
- **Accumulated Deficit**: $844.8 million as of December 31, 2023.

## Market Landscape
- **Target Population**: AHF affects approximately 6 million people in the U.S. and poses significant mortality risks; the market potential for AHF is estimated at two million patients representing billions in annual market value.
- **Competitive Environment**: Windtree faces competition from established firms with greater resources in the biotechnology and pharmaceutical sectors.

## Strategic Goals
Windtree Therapeutics aims to maximize the clinical potential of its product candidates and seeks partnerships to facilitate further development, especially in capital-intensive phases such as Phase 3 clinical trials and commercialization. Their focus on innovative therapies in acute care settings positions them to address significant unmet medical needs in cardiovascular and oncology markets.

WINDTREE THERAPEUTICS INC /DE/

10-K / April 15, 2025

10-K / April 16, 2024

10-K / April 15, 2025

Company Summary: Windtree Therapeutics, Inc.

Overview

Key Products & Development Pipeline

Business Strategy

Operational & Financial Details

Summary