Windtree Therapeutics Continues to Advance in Market with Ambitious Strategies; Reports Financial Results of Q4 and Fiscal Year 2023

Windtree Therapeutics

WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a leading biopharmaceutical company, delivered its financial results for the fourth quarter and fiscal year, that ended December 31, 2023.

The past year has been a dynamic period for the company as it enhanced its clinical programs, liaised a license for cardiovascular assets, bolstered the balance sheet, and recently acquired a novel oncology preclinical atypical protein kinase C iota inhibitor (aPKCi inhibitor) platform from Varian Biopharmaceuticals. All these actions partake in a broader portfolio optimization strategy, marking a pivotal step for Windtree.

The company’s objective is to read out data from ongoing Phase 2 istaroxime trials in cardiogenic shock later this year. Moreover, the company is working with regional partner Lee’s Pharmaceutical and is discussing global partnership options for istaroxime in order to boost the progress of istaroxime while managing the present and future clinical trials and gaining potential deal revenue. The company’s strategy is to propel the late-stage istaroxime program by collaborating with a more substantial company, thus facilitating the advancement of their preclinical programs.

Windtree’s [CEO], Craig Fraser, stated that believing in the power of partnerships could ensure the progress of their istaroxime program regionally and globally. This type of collaboration could prove beneficial for the company by reducing cash burn, extending the runway, and allowing the company to leverage its experienced team to advance its innovative early-stage platforms. Looking ahead, Fraser asserted that there might be an opportunity to broaden their internal programs, increase deal revenue, and fortify their balance sheet to selectively dedicate resources for other potential acquisitions and strategic transactions, aiming to enhance the business and its value.

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The company’s R&D and clinical team has made significant advancements with the istaroxime program in cardiogenic shock, having launched two clinical trials. Notably, the integration of their newly acquired aPKCi inhibitor into their preclinical portfolio promises to offer an exciting preclinical data package.

In addition to its scientific undertakings, Windtree confirmed several key business strategies in the past months. These include an asset purchase agreement with Varian Biopharmaceuticals, the enrollment of the first subject in its Phase 2 SEISMiC Extension Study of istaroxime, a license agreement with Lee’s Pharmaceutical, a renewed partnership with Chang Gung University, and the initiation of an Exchange and Termination Agreement with Deerfield.

Financial results showed an increase of research and development expenses from $1.2 million in Q4 2022 to $3.1 million for Q4 2023. Despite a net loss of $5.2 million ($0.95 per basic share) for the quarter ended 2023, the company remains optimistic.

The R&D expenses for 2023 stands at $8.3 million compared to $11.1 million in 2022, showing a decrease. Meanwhile, the general and administrative expenses were recorded at $9.2 million, which is a decrease from the previous year’s $10.8 million. The net loss for the year 2023 was reported as $20.3 million ($5.24 per basic share) compared with the net loss of $39.2 million ($62.23 per basic share) in 2022.

As of December 31, 2023, the company reported cash and cash equivalents at $4.3 million and the current liabilities at $4.0 million. Moreover, the company completed a $1.5 million convertible note bridge financing in April 2024. As a result of these financial strategies and developments, Windtree believes it has sufficient resources to fund its operations through April 2024.

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Windtree Therapeutics, Inc. filed its Annual Report on Form 10-K for the year ended December 31, 2023, with the Securities and Exchange Commission on April 16, 2024. This document provides a more detailed discussion of the Company’s business plans, operations, financial status, and results of operations, for the year.

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