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Windtree Therapeutics, Inc. (NASDAQ: WINT) is a pioneering biotechnology company specializing in the development of innovative therapies for critical cardiovascular and respiratory conditions. The company's advanced research and proprietary technologies aim to address significant unmet medical needs, offering hope to patients and their families.
At the core of Windtree's portfolio is its KL4 surfactant technology, a synthetic, peptide-containing surfactant structurally similar to human pulmonary surfactant. This technology is being developed for noninvasive administration via aerosolization, with a primary focus on treating Respiratory Distress Syndrome (RDS) in premature infants. The potential of this technology extends to various other respiratory diseases, promising new therapeutic avenues where few or no approved treatments exist.
In the cardiovascular domain, Windtree is advancing istaroxime, a Phase 2 candidate exhibiting unique dual mechanisms that enhance both systolic and diastolic cardiac functions. Istaroxime targets acute heart failure and cardiogenic shock, conditions with high mortality and limited treatment options. Recent collaborations, including a significant license agreement with Lee's Pharmaceutical, aim to develop and commercialize istaroxime in Greater China, reflecting its global potential.
Windtree is also exploring preclinical SERCA2a activators for heart failure, aiming to develop both intravenous and oral formulations to treat acute and chronic heart failure, respectively. Additionally, the company is advancing rostafuroxin, targeting hypertension in patients with specific genetic markers, and a preclinical atypical protein kinase C iota (aPKCi) inhibitor, for potential oncology applications.
Financially, Windtree's strategic licensing and partnerships, such as the recent agreement with Deerfield Management to retire a $15 million liability, have strengthened its balance sheet. The company is strategically positioned to advance its late-stage clinical programs while optimizing its financial resources to support ongoing and future endeavors.
Windtree's commitment to scientific innovation and strategic collaborations is poised to transform treatment paradigms in cardiovascular and respiratory care, with a robust pipeline that holds significant promise for the future.
Windtree Therapeutics (NasdaqCM: WINT) has released findings from the SEISMiC Study, demonstrating that istaroxime significantly improves systolic blood pressure (SBP) in patients with early cardiogenic shock due to heart failure. The study showed a 93.6% relative increase in SBP AUC over the first 6 hours with the 1.0 μg/kg/min dose, compared to a 39.5% increase with the higher dose of 1.5 μg/kg/min. Importantly, istaroxime therapy did not worsen renal function. These results were published in the Journal of Cardiac Failure, highlighting the drug's potential as a first-in-class treatment for acute heart failure conditions. Dr. Steve Simonson from Windtree noted the findings will inform future development strategies for istaroxime.
Windtree Therapeutics has successfully completed its underwritten public offering of 3,686,006 shares of common stock, raising approximately $12.4 million before expenses. Each share was priced at $2.93 and sold alongside a warrant to purchase an additional share. The offering included the underwriter's full option to buy an additional 552,900 shares and warrants. Windtree plans to allocate up to $3.5 million of the net proceeds to extend enrollment and complete a Phase 2 clinical trial for istaroxime, a candidate for treating cardiogenic shock, with the remainder directed towards working capital. The securities were offered under Windtree's registration statement, effective April 19, 2023.
Windtree Therapeutics has announced the pricing for its underwritten public offering, consisting of 3,686,006 shares of common stock and warrants to purchase the same amount. The combined offering price is set at $2.93 per share and accompanying warrant, with an expected gross proceeds of approximately $10.8 million. Proceeds are earmarked primarily for the completion of a Phase 2 clinical trial for istaroxime in cardiogenic shock, with the remainder allocated for working capital. The offering is anticipated to close around April 24, 2023, pending standard closing conditions. Ladenburg Thalmann & Co. Inc. serves as the sole book running manager. Additionally, the underwriter has a 45-day option to purchase up to 552,900 shares or warrants. This offering has been filed with the SEC under Form S-1.
Windtree Therapeutics (NasdaqCM: WINT) announced that the European Patent Office has granted Patent No. 3599243, protecting a class of SERCA2a Activators for heart failure treatment until July 2038. This patent covers dual mechanism drug candidates that both activate SERCA2a and inhibit the Na+/K+ pump. Unlike existing treatments, these candidates may offer both intravenous and oral therapies for acute heart failure and chronic heart failure management.
CEO Craig Fraser highlighted the significance of SERCA2a activation in advancing heart failure treatment. Windtree's platform also includes istaroxime, a first-in-class therapy that improves cardiac function.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) reported its financial results for Q4 and the fiscal year ending December 31, 2022. For Q4, the company reduced its operating loss to $10.8 million from $14.7 million in Q4 2021. The net loss was $9.7 million ($13.01 per share) compared to $13.1 million ($23.22 per share) the previous year. R&D expenses fell to $1.2 million in Q4 2022 from $4.5 million in Q4 2021, primarily due to focused resource allocation on the istaroxime pipeline. The company also issued a new patent for istaroxime, signaling advancement in its cardiovascular treatment efforts.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that it has regained compliance with Nasdaq's minimum bid price requirement, as detailed in a Bid Price Compliance Letter received on March 13, 2023. The company had previously fallen below the $1.00 bid price threshold, receiving a notification on June 3, 2022. However, Windtree successfully maintained a closing bid price above $1.00 for ten consecutive trading days, achieving compliance with Nasdaq Listing Rule 5550(a)(2). This milestone supports Windtree's ongoing development of cardiovascular interventions, including istaroxime for acute heart failure.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced findings from a market study highlighting the substantial healthcare costs and lengthy hospital stays associated with cardiogenic shock. Data reveals an average hospital stay of 19.6 days, significantly higher than the 5.5 days average for all hospitalizations. The company is focusing on its drug candidate, istaroxime, which demonstrated promising results in a Phase 2 study, showing improved systolic blood pressure in treated patients. Market research indicates a strong need for innovation, with 99% of surveyed cardiologists acknowledging the need for new treatments, and 84% expressing willingness to prescribe istaroxime.
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