Windtree Therapeutics to Host Virtual R&D and Investor Day Focusing on the Cardiogenic Shock Market, Istaroxime, Company Strategy and Planned Near-Term Milestones

Virtual event to take place on June 14, 2023 at 1:00 pm ET

WARRINGTON, Pa., June 05, 2023 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced it will host a virtual R&D and Investor Day on Wednesday, June 14, 2023 at 1:00 PM ET. The program will feature the Company’s lead drug candidate, istaroxime, a first in class, dual-acting agent, being developed to treat cardiogenic shock and acute decompensated heart failure. Istaroxime is designed to improve systolic contraction and diastolic relaxation of the heart.

The event will feature insights from John Teerlink, MD, Director of Heart Failure and of the Echocardiography Laboratory, San Francisco Veterans Affairs Medical Center and an active leader in US and European Heart Failure medical associations. Dr. Teerlink has been the principal investigator in many of the largest heart failure and cardiogenic shock studies and recently served a four-year term on the FDA’s Cardiovascular and Renal Advisory Committee. Dr. Teerlink will discuss the unmet medical need and current treatment landscape for patients suffering from cardiogenic shock and severe heart failure – a condition with high mortality, morbidity and unmet need and put the unique profile of istaroxime and its data into perspective.

Members of Windtree’s leadership team will present istaroxime early cardiogenic shock study data and provide insight into the istaroxime expanded development strategy and planned near-term milestones. Additionally, strategy related to acute heart failure, the follow-on oral, SERCA2a activators and business development will be discussed.

A live question and answer session will follow the presentations. The session will be available for replay on the Company’s website www.windtreetx.com. To register for the event, please click here.

About John Teerlink, MD
John Teerlink, MD, is Director of Heart Failure and of the Echocardiography Laboratory at the San Francisco Veterans Affairs Medical Center in San Francisco, California. He graduated from Swarthmore College with Highest Honors in Comparative Religious Studies and Cellular Biology. After receiving his medical degree from Harvard Medical School, where he performed a year of research in the laboratory of Drs. Janice and Marc Pfeffer, he completed an internal medicine residency at the University of California San Francisco (UCSF). He continued his basic science training through a post-doctoral research fellowship at Hoffman-LaRoche in Basel, Switzerland with Drs. Martine and Jean-Paul Clozel. Dr. Teerlink completed his cardiovascular medicine fellowship and a Howard Hughes post-doctoral research fellowship at UCSF, subsequently joining the faculty, where he currently is a Professor of Clinical Medicine. 

Dr. Teerlink has been an active member of the Heart Failure Society of America, serving on many committees including the Membership, Scientific Program, Corporate Affairs, Development, Lifetime Achievement Award and Guideline Committees and currently serves as President and on the Board of Directors and the Executive Council. He has also served on the Acute Heart Failure Committee of the European Society of Cardiology Heart Failure Association and the National Committee on Heart Failure and Transplantation of the American Heart Association. He is a founding and charter physician member of the American Association of Heart Failure Nurses. Dr. Teerlink completed a four-year term as a permanent member of the United States Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee, and frequently serves as an ad hoc member of multiple other FDA advisory committees and panels for medical devices, diagnostics, biologics and drugs. He is a member of the joint FDA/Duke University Standardized Data Collection for Cardiovascular Clinical Trials Initiative to develop standardized definitions for cardiovascular endpoints. He was an Associate Editor for the Journal of Cardiac Failure and a Guest Editor-in-Chief for JACC: Heart Failure, and is currently an Associate Editor for the European Journal of Heart Failure. He is a clinical scholar presenting many lectures and publications, including a chapter on Acute Heart Failure in Braunwald’s Heart Disease textbook. He was profiled in The Lancet as an internationally recognized leader in heart failure.

About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with acute heart failure (AHF) demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.

About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and for early cardiogenic shock. Windtree’s heart failure platform includes follow-on pre-clinical SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensees, Lee’s Pharmaceutical (HK) Ltd. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product 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 some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important 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 economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials, clinical trial timelines or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates; the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. 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, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone 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 its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that 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.

Contact Information:

Monique Kosse
LifeSci Advisors
212.915.3820 or monique@lifesciadvisors.com

Media:
Katie Larch / Robert Flamm, Ph.D.
Burns McClellan, Inc.
klarch@burnsmc.com / Rflamm@burnsmc.com