الأربعاء، 15 يناير 2025

Pre-Market: Windtree Therapeutics (Nasdaq: WINT) Needs All Eyes On It This Morning

*Sponsored


Just Announced!


Windtree Therapeutics, Inc. (Nasdaq: WINT) is Our Next 

Potential Breakout Idea..


And Here’s Why…


Low Float Potential: Fewer than 11.1M shares outstanding could lead to the potential for major movements.


Analyst Target: HC Wainwright & Co. recently reiterated a $7.00 target, suggesting over 2,722% potential upside.


Strategic Growth: New plans to acquire FDA-approved products aim to drive revenue generation.


Consider adding (WINT) to your radar this week…








January 15, 2025



Dear Reader,



Coming off of Monday’s biotech that swung for an approximate 20% in just a few hours, we’re now turning our attention to Windtree Therapeutics, Inc. (Nasdaq: WINT).


Pay close attention here because Windtree Therapeutics, Inc. (Nasdaq: WINT) has less than 11.1M shares outstanding. With a float this low, the scarcity could lead to the potential for significant swings if demand begins to shift.


Last month, on 12/4, Benzinga reported that HC Wainwright & Co., one of Wall Street’s oldest institutions, had reiterated a $7.00 target on Windtree Therapeutics, Inc. (Nasdaq: WINT). 


This target suggests over 2,722% in potential upside from today’s $.248 open.

Keep reading to see why we’re so excited about Windtree Therapeutics, Inc. (Nasdaq: WINT) and have it pinned to the top of our watchlist for this morning…


Windtree Therapeutics, Inc. (Nasdaq: WINT) is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. 


Windtree Therapeutics, Inc. (Nasdaq: WINT)’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a-activating properties for acute heart failure and associated cardiogenic shock. 


The pipeline also features preclinical SERCA2a activators for heart failure and a precision aPKCi inhibitor being developed for potential use in rare and broad oncology applications.


Windtree also has a licensing business model with partnership out-licenses currently in place.


Recent Developments


Windtree Targets FDA-Approved Products for Revenue Expansion

In a bold move to drive revenue and enhance its innovation pipeline, Windtree Therapeutics, Inc. (Nasdaq: WINT) has launched a new corporate strategy aimed at becoming a revenue-generating biotech company. 


This strategy focuses on acquiring small companies with FDA-approved products, leveraging the management team’s deep commercialization expertise to maximize their market potential.


“We believe that Windtree becoming a revenue-generating company would be a significantly positive transformation and would mark a new chapter in our growth story,” said Jed Latkin, CEO of Windtree. 


“By pursuing this strategy, we maintain our commitment to advancing our promising cardiovascular and oncology pipeline while simultaneously leveraging our deep commercialization expertise to accelerate revenue growth through strategic acquisitions.”


This approach positions Windtree to create near-term value while preserving its commitment to breakthrough innovation, marking a pivotal evolution for the company.



A Transformative Pipeline: Focus on Cardiogenic Shock and

Acute Heart Failure

At the core of Windtree Therapeutics, Inc. (Nasdaq: WINT)’s is istaroxime, a groundbreaking therapy with a dual mechanism of action targeting cardiogenic shock (CS) and acute heart failure (AHF). 

Unlike existing treatments that often come with severe side effects and limited efficacy, istaroxime is uniquely designed to:


  • Improve both systolic and diastolic cardiac function.
  • Raise blood pressure and enhance organ perfusion.
  • Preserve renal function while avoiding the increased risk of arrhythmias.


Cardiogenic Shock: A Life-Threatening Condition


Cardiogenic shock, marked by critically low blood pressure and insufficient blood flow to vital organs, is a life-threatening condition impacting thousands each year. 


Valued at $1.25B globally, the market for istaroxime presents significant potential for addressing the underlying causes of this condition.


Phase 2 studies have demonstrated notable improvements in:


  • Systolic Blood Pressure (SBP), maintained throughout the infusion period.
  • Stroke volume and cardiac output, critical metrics for heart function.
  • Mixed venous oxygen saturation (SVO2), indicating better organ perfusion.


Acute Heart Failure: Addressing a Critical Gap


AHF remains one of the costliest and most complex conditions to manage, with no significant pharmacological advancements in decades. 


Istaroxime’s Phase 2a and 2b studies demonstrated its ability to:


  • Lower pulmonary capillary wedge pressure (PCWP).
  • Improve systolic blood pressure and stroke volume.
  • Maintain or enhance renal function—a key differentiator from current therapies.


Windtree Therapeutics, Inc. (Nasdaq: WINT) is gearing up for Phase 3 studies in partnership with its Asia-Pacific licensee, Lee’s Pharma, which is leading development in the region. 


The company’s strategy to focus on patients with low blood pressure and diuretic resistance underscores its commitment to addressing the highest unmet needs in heart failure care.


Oncology Expansion: The aPKCi Inhibitor Platform


In a strategic move to diversify its portfolio, Windtree has acquired a first-in-class atypical protein kinase C iota (aPKCi) inhibitor platform. This innovative oncology program targets multiple tumor types with both topical and oral formulations. The potential applications span:


  • Cutaneous malignancies like basal cell carcinoma (BCC) and Gorlin Syndrome.
  • Systemic cancers, including non-small cell lung cancer (NSCLC) and pancreatic cancer.


Preclinical studies have revealed promising results, including:


  • Dose-dependent efficacy in murine and human cancer cell lines.
  • Favorable pharmacokinetic and tolerability profiles in animal models.


The company plans to advance this platform through IND-enabling studies in 2024, leveraging its unique mechanism of action to address significant gaps in oncology treatment.


Positive Results from Clinical Studies


Windtree’s SEISMiC studies have been a cornerstone of its clinical development:


  • SEISMiC Part A: Demonstrated rapid and sustained increases in SBP in early cardiogenic shock patients.
  • SEISMiC Part B: Extended these findings, showing improved wedge pressure, cardiac output, and renal function.


The safety profile of istaroxime has been consistently favorable, with fewer serious adverse events compared to placebo and no increase in significant arrhythmias.


Strategic Partnerships and Financial Strength


Windtree’s approach to capital efficiency is underpinned by strategic licensing deals:


  • Greater China License for Cardiovascular Assets: A $138 Mln agreement with Lee’s Pharma, including milestone payments and royalties.
  • Global License for KL4 Surfactant Platform: A $78.9 Mln deal with development costs fully borne by the partner.


These partnerships not only validate Windtree’s technologies but also provide the financial flexibility to advance its core programs.


A Vision for Market Leadership


With an estimated $1.25B market potential in cardiogenic shock and an emerging presence in oncology, Windtree Therapeutics, Inc. (Nasdaq: WINT) is positioning itself for growth. 


The company’s dual emphasis on innovative cardiovascular and oncology therapies aligns with its mission to deliver transformative value for patients, healthcare providers, and stakeholders.


Key Milestones for 2024 and Beyond

Windtree Therapeutics, Inc. (Nasdaq: WINT)’s roadmap includes several critical deliverables:


  • Phase 2b SEISMiC Extension Study: Top-line data expected in late Q3 2024.
  • Oncology IND-Enabling Activities: Progress in aPKCi inhibitor development.
  • Strategic Transactions: Exploring additional licensing and acquisition prospects.


Why Windtree Therapeutics, Inc. (Nasdaq: WINT) Matters


Windtree Therapeutics, Inc. (Nasdaq: WINT) represents the cutting edge of biopharmaceutical innovation. By addressing significant unmet needs in cardiovascular and oncology markets, the company is creating therapies that save lives and improve outcomes for patients worldwide. 


With a strong pipeline, experienced leadership, and strategic partnerships, Windtree is on a trajectory to redefine standards of care and create sustainable value.


7 Reasons Why Windtree Therapeutics, Inc. (Nasdaq: WINT) is Topping Our Watchlist This Morning… 


1. Low Float: With fewer than 11.1 Mln shares outstanding, (WINT)’s low float could lead to significant movements if demand begins to increase.


2. Analyst Confidence: HC Wainwright & Co. recently reiterated a $7.00 target on (WINT), which suggests over 2,722% in potential upside from today’s open.


3. A Diverse and Innovative Pipeline: (WINT)’s portfolio includes istaroxime for acute heart failure and cardiogenic shock, preclinical SERCA2a activators, and precision oncology therapies, addressing both common and rare conditions.


4. Strategic Expansion Plans: (WINT)’s recent shift toward acquiring FDA-approved products showcases its intent to become a revenue-generating biotech leader while continuing to advance its innovative pipeline.


5. Proven Clinical Progress: Positive Phase 2 results for istaroxime demonstrated improvements in cardiac function and organ perfusion, offering a promising approach to high-mortality conditions like cardiogenic shock.


6. Robust Licensing Partnerships: The company has secured significant deals, such as a $138 Mln cardiovascular asset license with Lee’s Pharma, strengthening its financial position and validating its technology.


7. Upcoming Milestones: With top-line data expected from its Phase 2b SEISMiC Extension Study in late Q3 2024 and progress in oncology IND-enabling activities, (WINT) is positioning itself for significant developments in the near future.


With a low float, strong analyst confidence, and a diverse, innovative pipeline, Windtree Therapeutics, Inc. (Nasdaq: WINT) has the potential to capture attention as it advances its strategic plans and clinical milestones. 


Backed by proven progress, robust licensing partnerships, and upcoming developments, (WINT) is pinned to the top of our watchlist for this morning…


Consider taking a look at (WINT) while it’s still early.


We have (WINT) at the top of our screens right now.


Keep an out for my next update.



I’ll follow up with you shortly.


Sincerely,


Jeff Ackerman

Managing Editor

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