Windtree Announces Conference Call to Present Data from its Positive Phase 2 SEISMiC Study of Istaroxime in Early Cardiogenic Shock
The call will take place on Monday, May 23 at 4:30 p.m. EDT following the last-minute presentation at the European Society of Cardiology meeting on heart failure
WARRINGTON, Pa., May 16, 2022 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced that management will host a conference call and webcast to discuss its Phase 2 study of istaroxime in patients with early cardiogenic shock following the presentation of data at the European Society of Cardiology meeting on heart failure in Madrid, Spain on May 23, 2022.
The company had previously announced a positive result from the trial and explained that further details were under embargo due to the acceptance of the late presentation at the heart failure meeting. On the call, management plans to present additional study results, including secondary measures associated with changes in blood pressure, systolic and diastolic cardiac function, renal profile, safety and tolerability. . The next stages of development and the broader prospects of the Company will also be presented.
Shareholders and other interested parties may participate in the conference call by dialing (877) 423-9813 (in the United States) or (201) 689-8573 (outside the United States) and entering the passcode. access 13729819. The call will also be webcast live and available by clicking the link HERE. A link to the webcast is also available on the Events page of the Company’s website: https://ir.windtreetx.com/events.
A replay of the call will be available on the Company’s website for 90 days at https://ir.windtreetx.com/events.
About Cardiogenic Shock Cardiogenic shock is a serious condition that occurs when the heart fails significantly and cannot pump enough blood and oxygen to the brain, kidneys and other vital organs. Mortality rates are significant and, depending on severity, range from 7% to 40% in the United States. a dysfunction or even an increase in mortality which limits their usefulness and positions them as “rescue drugs” for serious cases. Market research found that 99% of 100 US-based clinical cardiologists surveyed who treat cardiogenic shock patients responded that new drug innovations to treat SCAI Class B cardiogenic shock patients are highly needed. The total market value of cardiogenic shock worldwide is estimated at $1.25 billion, calculated using hospital claims of cardiogenic shock patients in the United States and global prevalence data multiplied by various assumed regional prices of the treatment medicated.
About Istaroxime Istaroxime is a first class dual mechanism therapy designed to improve both systolic and diastolic heart function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complementary mechanism that facilitates myocardial relaxation through activation of the calcium pump SERCA2a on the sarcoplasmic reticulum, improving reuptake of calcium from the cytoplasm. Data from several phase 2 studies in patients with acute heart failure (AHF) demonstrate that intravenously administered istaroxime significantly improves cardiac function and blood pressure without causing an increase in heart rate or arrhythmias.
About Windtree Therapeutics Windtree Therapeutics, Inc. is advancing several late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in crisis. Using novel scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds capable of activating SERCA2a, with the lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock. Windtree’s heart failure platform also includes follow-on oral preclinical SERCA2a activator assets. In pulmonary care, Windtree focused on facilitating clinical development transfer of AEROSURF®, to its licensee in Asia, Lee’s HK. Windtree is also evaluating surfactant KL4 for the treatment of acute respiratory distress syndrome in COVID-19 patients. Windtree’s portfolio includes rostafuroxin, a new precision drug targeting hypertensive patients with certain genetic profiles.
Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The Company may, in certain circumstances, use terms such as “predicted”, “believes”, “potential”, “proposed”, ” continues”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “could”, “will”, “should” or other words that reflect the uncertainty of future events or results to identify such forward-looking statements.These statements are based on information available to the Company as of the date of this press release and are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations Examples of such risks and uncertainties include: risks and uncertainties associated with the continued economic and social consequences of the VOC pandemic ID-19, including any adverse impact on the Company’s clinical trials, clinical trial delays or supply chain disruptions; the success and progress of clinical development programs for istaroxime, surfactant KL4 and the Company’s other product candidates; the impacts of political unrest, including resulting geopolitical tensions, including the escalation of the conflict between Russia and Ukraine and any additional sanctions, export controls or other restrictive measures that may be imposed by the United States and/or other countries and which could have an adverse impact on the Company’s operations, including by disrupting the supply chain or access to potential international clinical trial sites, and by disruption, instability and volatility in global markets, which could adversely impact the Company’s ability to access capital markets; the Company’s ability to obtain significant additional capital as needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute its operating plans and budgets; the results, cost and timing of the Company’s clinical development programs, including delays in such clinical trials related to registration or site initiation; risks related to technology transfers to subcontractors and manufacturing development activities; delays experienced by the Company, contractors or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials in a timely manner and in sufficient quantities; risks related to stringent regulatory requirements, including that: (i) the FDA or other regulatory authorities may disagree with the Company on issues raised during regulatory reviews, may require significant additional activities, or may not accept or withhold or delay consideration of applications, or may not approve or limit the approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make more difficult to obtain regulatory approvals and the risks associated with the Company’s efforts to maintain and protect patents and licenses related to its product candidates; the risks that the Company may never realize the value of its intangible assets and may incur future impairment charges; risks relating to the size and growth potential of markets for the Company’s product candidates, and the Company’s ability to serve such markets; the Company’s ability to develop its sales and marketing capabilities, alone or with potential future employees; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the Company’s periodic reports, including Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements the Company makes in this press release speak only as of the date of this press release. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
Contact information: Monique Kosse LifeSci Advisors 212.915.3820 or [email protected]
Media contact: Andrew Mielach LifeSci Communications 646.876.5868 or [email protected]