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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 reported a net loss of $32.6 million for 2020, with an operating loss of $30.3 million. In Q4 2020, the company had a net loss of $7.5 million, reflecting increased expenses in R&D and G&A. The company completed a $30 million equity financing in Q1 2021, netting approximately $27.3 million to fund ongoing clinical trials for istaroxime and KL4 surfactant. The company also announced a new patent for its AEROSURF device, extending protection until 2039. Cash and equivalents stood at $16.9 million at year-end 2020.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) has closed a public offering of 9,230,500 shares of common stock at $3.25 per share, generating gross proceeds of approximately $30 million. The offering included warrants to purchase an equal number of shares at an exercise price of $3.60. Proceeds will fund the advancement of the lead product istaroxime for acute heart failure and continue developing other pipeline candidates. Oppenheimer & Co. and Ladenburg Thalmann acted as managers for the offering, which was conducted under a previously effective shelf registration statement.
Windtree Therapeutics (WINT) announced the pricing of a public offering of 9,230,500 shares of common stock at $3.25 each, including warrants to purchase the same number of shares. The offering aims to raise approximately $30 million in gross proceeds, set to close on March 25, 2021. Funds will be allocated for advancing istaroxime, a new treatment for acute heart failure, and other pipeline candidates, alongside general corporate expenses.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) has initiated an underwritten public offering of its common stock and warrants, intended to finance the advancement of its lead product, istaroxime, for acute heart failure, alongside other pipeline candidates. The offering is contingent on market conditions, with no guarantee on its completion or terms. Proceeds will also support a second phase 2b clinical trial and general corporate purposes. Oppenheimer & Co. Inc. and Ladenburg Thalmann & Co. Inc. are managing the offering, filed under Windtree's shelf registration statement.
Windtree Therapeutics (NasdaqCM: WINT) announced an extension of its collaboration with the University of Milan-Bicocca to develop new SERCA2a compounds aimed at treating chronic and acute heart failure. Over the next year, the focus will be on characterizing SERCA2a activators and their interactions with related proteins. This collaboration bolsters Windtree's SERCA2a program, which includes istaroxime, a dual-action agent currently in a Phase 2 study for acute decompensated heart failure and granted Fast Track designation by the FDA based on positive trial results.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that CEO Craig Fraser will present at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 10:40 AM ET. A live audio webcast will be available on Windtree's website, with a replay accessible for 30 days. Windtree is focused on developing therapies for acute cardiovascular and pulmonary disorders, including its lead candidate istaroxime for heart failure and AEROSURF® for respiratory distress in infants. For more details, visit www.windtreetx.com.
Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that CEO Craig Fraser will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The company focuses on advancing late-stage interventions for acute cardiovascular and pulmonary disorders, including istaroxime for acute heart failure and AEROSURF® for respiratory distress in premature infants. A live audio webcast will be available on the company's website, with a replay for 30 days. For further details, visit www.windtreetx.com.
Windtree Therapeutics, Inc. (WINT) announced the issuance of U.S. Patent No. 10,874,818 for its aerosol delivery system (ADS) related to the AEROSURF device. This patent, effective until 2039, enhances their IP portfolio in aerosolized pulmonary surfactants. The redesigned ADS features improved ergonomics and reduced treatment interruptions, potentially improving clinical outcomes for patients with respiratory distress syndrome. CEO Craig Fraser expressed confidence in the company's ongoing efforts to strengthen its intellectual property across its product lines, including istaroxime for acute heart failure.
Windtree Therapeutics (NasdaqCM: WINT) announced the appointment of Dr. Evan Loh, Ms. Leslie Williams, and Dr. Rob Scott to its Board of Directors, following a board composition analysis to meet the company’s evolving needs. The new members bring extensive experience in drug development and commercialization. Former directors John Leone, Joseph Mahady, and Brian Schreiber will retire, leaving a seven-member board. CEO Craig Fraser expressed optimism about the new appointments aligning with Windtree’s late-stage trials for istaroxime and lucinactant, enhancing strategic growth.
Windtree Therapeutics, a biotechnology company focused on acute cardiovascular and pulmonary disorders, has appointed Dr. Joseph Soffer as Executive Director of Clinical Development. This appointment aims to bolster efforts in the istaroxime program, targeting acute heart failure. Dr. Soffer brings over 30 years of experience, previously serving as a Senior Medical Director at GlaxoSmithKline. In connection with his role, he has been granted a stock option to purchase 100,000 shares at a closing price determined on January 29, 2021.
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