Windtree Therapeutics Reports Second Quarter 2022 Financial Results and Provides Key Business Updates

Windtree Therapeutics

WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) recently reported financial results for the second quarter ended June 30, 2022, and provided key business updates.

“Since announcing the positive topline results from our Phase 2 SEISMiC study of istaroxime in early cardiogenic shock, we have received notable interest and positive scientific and biopharma industry responses in what has been widely recognized as a differentiated and desirable therapeutic profile to address a significant opportunity in the major markets of cardiogenic shock and heart failure,” said Craig Fraser, President and Chief Executive Officer of Windtree. “Positive SEISMiC study results have paved the way for what we believe could be a relatively fast and less expensive developmental and regulatory pathway and as such, we are executing study start-up for an extension to the SEISMiC study designed to optimize dosing for Phase 3. To support this opportunity, we have optimized our cash runway and aligned our resources and activities to focus on our cardiogenic shock program. We believe istaroxime presents a compelling opportunity to build value and help critically ill patients. We look forward to delivering additional clinical milestones and meeting with regulatory agencies to define the next steps in our development path to potential approval.”

Key Business Updates

  • Announced the SEISMiC early cardiogenic shock study of istaroxime met its primary endpoint in systolic blood pressure (SBP) profile over six hours with the istaroxime treated group performing significantly better compared to the control group and significant improvements through the 24-hour SBP profile measurement. The SBP increases were rapid, appearing within the first hour and sustained through the last measure at 96 hours. Istaroxime treatment also demonstrated improvement in cardiac index compared to control, and other key secondary measurements associated with cardiac function were significantly improved as well. Importantly, renal function and heart rate were maintained.
  • Presented the results of SEISMiC as a late-breaker presentation at the European Society of Cardiology Heart Failure Conference in Madrid, Spain. The presentation, entitled: “The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock,” was given by Dr. Marco Metra, Professor of Cardiology and Director of the Institute of Cardiology of the Department of Medical and Surgical Specialties, Radiological Sciences and Public Health of the University and Civil Hospitals of Brescia, Italy, and Principal Investigator of the Company’s Phase 2 SEISMiC study of istaroxime in early cardiogenic shock. Dr. Metra highlighted key details and results of the study, a summary of which can be found on the company’s Events page: https://ir.windtreetx.com/events 
  • SEISMiC was also presented at the Critical Care Clinical Trialists meeting in Washington, DC by Dr. Alex Mebazza, Professor of Anesthesiology and Critical Care Medicine, Paris Diderot School of Medicine. Additionally, the trial was presented and discussed at an accompanying cardiogenic shock workshop.
  • The Company announced that it is leveraging positive istaroxime early cardiogenic shock results, and the interest from potential partners that it created, to proactively engage in formal licensing discussions and explore strategic opportunities that may lead to greater shareholder value.
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Select Financial Results for the Second Quarter ended June 30, 2022

For the second quarter ended June 30, 2022, the Company reported an operating loss of $17.5 million, compared to an operating loss of $45.4 million in the second quarter of 2021. Included in operating loss for the second quarter of 2022 is non-cash expense of $11.6 million related to the impairment of goodwill. Included in operating loss for the second quarter of 2021 is non-cash expense of $37.8 million related to the impairment of the Company’s rostafuroxin intangible asset.

Research and development expenses were $3.0 million for the second quarter of 2022, compared to $4.2 million for the second quarter of 2021. The decrease in research and development expenses is primarily due to (i) a decrease of $0.5 million related to the Company’s decision in January 2022 to begin to reduce costs related to the KL4 surfactant platform; (ii) a decrease of $0.5 million in non-cash stock-based compensation expense; and (iii) a decrease of $0.2 million in direct clinical costs following the completion of enrollment in its Phase 2b study of lucinactant for patients with severe COVID-19 associated ARDS.

General and administrative expenses for the second quarter of 2022 were $2.9 million, compared to $3.4 million for the second quarter of 2021. The decrease in general and administrative expenses is primarily due to (i) a decrease of $0.3 million in non-cash stock-based compensation expense; and (ii) a decrease of $0.3 million in professional fees; partially offset by (iii) an increase of $0.1 million in personnel costs.

The Company reported a net loss of $17.3 million ($0.59 per basic share) on 29.2 million weighted-average common shares outstanding for the quarter ended June 30, 2022, compared to a net loss of $37.4 million ($1.42 per basic share) on 26.4 million weighted average common shares outstanding for the comparable period in 2021.

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As of June 30, 2022, the Company reported cash and cash equivalents of $11.4 million, which is expected to be sufficient to fund operations into the first quarter of 2023.

Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, which will be filed with the Securities and Exchange Commission on August 11, 2022, which includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.

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