Market research finds that 99% of US clinical cardiologists surveyed report a significant unmet need for new innovative drug therapies for patients with early cardiac arrest (ECS) as Windtree Therapies prepare for clinical results from the Istaroxime ECS study

The total market value of cardiogenic shock worldwide is estimated at $1.25 billion

WARRINGTON, Pa. 12, 2021 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc., announced today. (NasdaqCM: WINT), a biotechnology and medical device company focused on developing multiple interventions in the late stages of acute cardiovascular and pulmonary disorders, reports the results of a US physician survey and an assessment of the overall market value of cardiogenic shock worldwide. After two positive phase II studies of istaroxime in acute heart failure provided the rationale, Windtree began clinical development of istaroxime in the second pathology of early cardiogenic shock.

Cardiogenic shock is a serious condition that occurs when the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Cardiogenic shock is considered a medical emergency and should be treated immediately.1 It has a high in-hospital mortality (~30-40%) and significant morbidity in survivors.2 The cardiogenic shock classification system was developed by the Society for Cardiac Angiography and Interventions (SCAI). Class A patients, who are at risk of cardiogenic shock due to an acute event, are classified by stage E who present with circulatory collapse and require cardiopulmonary resuscitation and/or devices for support.

Using US Hospital cardiogenic shock claims and worldwide prevalence data, Windtree estimates the total worldwide cardiogenic shock market value at $1.25 billion. This estimate is calculated by multiplying patient numbers from the largest markets by the assumed different regional prices for pharmacotherapy consistent with other acute care treatments with similar incidence rates. The addressable market for istaroxime will be a subset of the total market capitalization of $1.25 billion.

Additionally, Windtree has conducted market research to understand how one of its key customer groups sees the need for innovation in this disease. Physician Market Research (conducted for Windtree by Sermo, the leading provider of real-time physician insights) asked 100 US-based clinical cardiologists who treat trauma patients about the need for new drug innovation to treat SCAI Class B trauma patients. (Windtree refers to these. Patients like those with early cardiogenic shock.) 99 out of 100 cardiologists answered that there is a significant need for pharmacological (pharmacological) innovation in SCAI Class B cardiogenic shock patients. In addition, 84% of cardiologists responded that they were highly likely to use a drug that had a profile that reflected the clinical profile of estaroxime in early-cardio shock patients. The majority of cardiologists also responded that they would put a drug with an istaroxime profile of use before using other classes of therapies such as inotropes and vasopressors.

The istaroxime Phase 2 study in early cardiogenic shock is an international, randomized, double-blind, placebo-controlled study. It will include approximately 60 patients with early cardiogenic shock in category B with severe heart failure – 30 assigned to estaroxime and 30 to placebo with systolic blood pressure (SBP) between 75-90 mmHg receiving a 24-hour study drug infusion. The primary end point is the difference in the SBP area under the curve within six hours after the start of the infusion. Secondary endpoints will include characterization of 24-hour blood pressure changes, number of patients requiring rescue therapy (vascular handles, inotropes or mechanical devices), assessment of renal function and related measures of safety and tolerability. Windtree expects the study to be completed in the fourth quarter of 2021.

2 Colti D, American Heart Association; 2014 Jan 13

About Istaroxime
Istaroxime is a first-in-class dual drug therapy designed to improve diastolic and systolic function of the heart. 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 SERCA2a calcium pump on the sarcoplasmic reticulum that promotes calcium uptake from the cytoplasm. Data from multiple phase II studies in patients with acute heart failure (AHF) show that intravenous esteroxime significantly improves heart function and blood pressure without causing increased heart rate or arrhythmias.

About Windtree Therapeutics
Windtree Therapeutics, Inc. He has developed several interventions in the late stages of acute cardiovascular and acute pulmonary disorders to treat patients in moments of crisis. Using novel scientific and clinical approaches, Windtree is developing a multi-asset franchise based on compounds with the ability to activate SERCA2a, with a key candidate, istaroxime, being developed as a first-line treatment for acute heart failure and early cardiogenic shock. The Windtree Heart Failure Platform includes oral SERCA2a activator assets for oral follow-up as well. In pulmonary care, Windtree has focused on developing AEROSURF®, a combination drug device, to deliver a non-invasive synthetic KL4 surfactant to premature infants with respiratory distress syndrome, and to facilitate the transfer of clinical development of AEROSURF® to its licensee in Asia, Hong Kong Lee. Windtree is also evaluating the surfactant KL4 for the treatment of acute respiratory distress syndrome in patients with COVID-19. Also in Windtree’s preservative is rostafuroxin, a new micro-drug product targeted at 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 some cases, use terms such as “predict,” “believe,” “likely,” “proposed,” “continued,” or “estimate.” “expect”, “expect”, “plan”, “intend”, “may”, “could”, “may”, “will”, “should” or any other words that convey uncertainty about future events or outcomes to determine this 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 many significant factors, risks and uncertainties that could cause actual events or results to differ materially from the Company’s current expectations Examples of such risks and uncertainties include: associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials or disruption to the supply chain; the success and progress of clinical development programs for istaroxime and KL4 surfactants and other Company candidate products; the Company’s ability to secure significant additional capital when need; ability of shirk gain access to the debt or equity markets; The company’s ability to manage costs and implement its operational plans and budget; the results, cost, and timing of the Company’s clinical development programs, including any delays in such clinical trials related to enrollment or site start-up; risks related to technology transfer for contracting with manufacturers and manufacturing development activities; delays experienced by the company, contract manufacturers or suppliers in the timely and in sufficient quantity manufacturing of pharmaceutical products, pharmaceutical materials, aerosol delivery systems (ADS) and other materials; Risks related to stringent regulatory requirements, including the following: (i) the Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, may not accept, may withhold or delay consideration of applications, may not approve or may limit approval of candidates for Company products, and (ii) changes in the national or international political and regulatory environment may increase the difficulty of obtaining regulatory approvals and risks related to Company efforts to maintain patents and licenses relating to its products candidate; The risk that the company may never realize the value of its intangible assets and have to incur impairment charges in the future; Risks related to the size and growth potential of the markets for the company’s product candidates, and the company’s ability to serve those markets; The company’s ability to develop sales and marketing capabilities, either on its own or with potential future collaborators; 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 the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed or filed with 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 assumes no obligation to update forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.

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