Windtree Therapeutics (NASDAQ: WINT) Is Developing A Multi-Asset Franchise Of Its Novel SERCA2a Activators In A Multi-Billion Dollar Market

Windtree Therapeutics, Inc. WINT is a biotechnology company developing treatments for severe cardiovascular disorders. It is targeting patients with acute heart failure (AHF) and cardiogenic shock (CS), as heart failure remains one of the leading causes of death in America.

Windtree’s leading drug product candidate is istaroxime, a first-in-class treatment that is being developed for indications in AHF and cardiogenic shock. The company has already successfully completed three positive phase 2 trials for istaroxime and is advancing to the next stage of development. 

With istaroxime, Windtree is positioning itself to bring much-needed solutions to the heart failure market. The congestive heart failure market was worth $6.7 billion in 2022, and the global market for cardiovascular drugs is worth $162.63 billion. North America makes up the largest segment of this market.

Developing A Platform For Next-Generation Drugs

Istaroxime uses a dual-mechanism of action that improves both systolic pumping action and diastolic cardiac relaxation function, and it provides the concept of one of Windtree’s objectives to develop a next generation to istaroxime which would give Windtree a multi-asset franchise anchored in its ability to activate SERCA2a. The goal for the next generation SERCA2a Activators is to formulate both intravenously (IV) and orally (pill) so administration could be given to patients in the hospital for acute treatment or in the hospital outpatient setting for chronic treatment. SERCA2a is a target within cells  that affects cardiac function, and activating it may help treat cardiovascular disorders, including heart failure. 

Windtree’s heart failure platform of activators includes both  dual-mechanism (like istaroxime) and pure SERCA2a activators and the company believes it could be developed into a next-generation family of drugs for treating heart failure. The dual mechanism compound, however, serves as both SERCA2a activators and Na/K pump inhibitors. This compound could potentially be a fast follow on to istaroxime which means that because they have a similar mechanisms to istaroxime, learnings from the istaroxime development plan can be applied which may result in a faster, less expensive and higher probability of success development pathway. The dual mechanism SERCA2a Activators could be an enhanced commercial opportunity over istaroxime because they could be utilized for acute heart failure for hospitalized patients and continued as chronic treatment with an oral formulation when the patient is discharged from the hospital. 

The pure SERCA2a activators are compounds that activate heart activity without inhibiting Na/K pump activities. There is a high need for innovation in chronic heart failure particularly in a segment called heart failure with preserved ejection fraction (HFpEF) where the primary cause of the heart failure is an inability to fully relax between heart beats and fill up with a proper amount of blood.

First Quarter Results

The company recently issued its Q1 financial results for 2023, including key business updates for the rest of the year. Windtree strengthened its balance sheet in April by raising $12.4 million in gross proceeds through a public offering of stock which included a full exercise of the overallotment option. 

In June, the United States Patent and Trademark Office (USPTO) gave a notice of allowance for the patent application for Wintree’s dual mechanism SERCA2a activators. This notice continues Windtree’s strategy of building its intellectual property portfolio for heart failure therapies. It also received patent coverage for its dual mechanism SERCA2a Activator class of drug candidates from the European Patent Office. 

The company’s research and development (R&D) expenses were $1.5 million, down from $5.3 million in Q1 2022, a cost decrease from the company’s streamlining of resources on istaroxime development. It also reduced its general and administrative expenses year-over-year, from $3 million in Q1 2022 to $2.3 million in Quarter 1 2023.

Craig Fraser, President and Chief Executive Officer of Windtree, commented on the news, “We plan to leverage the cost savings and successful financing to build on the positive Phase 2 data for istaroxime with significant development activity to deliver meaningful milestones over the next several quarters. We look forward to planned events and communication to keep our shareholders and the market updated on our progress with istaroxime and potential opportunities with the next generation SERCA2a Activators.”

Learn more about Windtree by visiting its website. 

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