Windtree Appoints Dr. Joseph Soffer to Lead Cardiovascular Clinical Development

WARRINGTON, Pa., Feb. 1, 2021 /PRNewswire/ -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today announced the appointment of Joseph Soffer, M.D., F.A.C.C., as Executive Director of Clinical Development, effective immediately.

"We are thrilled to welcome Joe to lead our cardiovascular clinical development efforts at such an important  time for Windtree," said Dr. Steve Simonson, Chief Medical Officer at Windtree Therapeutics. "Joe's expertise in cardiology and substantial experience with drug development in the pharmaceutical industry will be invaluable to our istaroxime program in acute heart failure, including our study in early cardiogenic shock."

Dr. Soffer commented, "I am delighted to join this dynamic team working on innovative products like istaroxime at such an exciting time of growth for the company. I look forward to helping the team develop the novel pipeline of assets to address a number of significant unmet needs in cardiovascular medicine."

Joseph Soffer, M.D., F.A.C.C., is a Board-certified physician in Cardiology and Internal Medicine with over 30 years of combined experience in industry, clinical practice, and academia. His medical expertise has focused on heart failure, ischemic heart disease, arrhythmias, lipid disorders, and hypertension, among other disease areas. Most recently, he served as the Senior Medical Director of Clinical Development at GlaxoSmithKline. In this role, he led the U.S. and international clinical development for cardiology assets and pharmacovigilance activities for late-stage trials. Previously, he served as Associate Medical Director of Medical Affairs at Merck and also worked at Medcases. Dr. Soffer's clinical trial experience has included early and late-stage clinical development ranging from Phase I to Phase IV, including successful approval of a cardiology asset in Europe and Canada. Prior to joining the pharmaceutical industry, Dr. Soffer was a practicing cardiologist for over fifteen years after receiving an M.D. from the University of Chicago, Pritzker School of Medicine, and an undergraduate degree from Rutgers University.

In connection with Dr. Soffer's appointment, the Board of Directors of Windtree granted Dr. Soffer a stock option to purchase 100,000 shares of Windtree's common stock. The exercise price of the stock option will be the closing price of Windtree's common stock on the Nasdaq Capital market on the date of the grant, January 29, 2021. The stock option is being granted to Dr. Soffer as an inducement material to him accepting employment with Windtree and is being granted outside of the Windtree Therapeutics, Inc.'s 2020 Equity Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options will vest in three equal annual installments beginning on the first anniversary of the grant date, subject to Dr. Soffer's continued employment with Windtree through the applicable vesting date.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis. Using new 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 early cardiogenic shock in heart failure. Windtree has also focused on developing AEROSURF® as a non-invasive surfactant treatment for premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee's HK, while Windtree  evaluates other uses for its synthetic KL4 surfactant for the treatment of acute pulmonary conditions including lung injury due to viral, chemical and radiation induced insults. Also in its portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.

For more information, please visit the Company's website at www.windtreetx.com.

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 ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company's clinical trials or disruption in supply chain; the success and advancement of the  clinical development programs for istaroxime, AEROSURF®, KL4 surfactant and the Company's other product candidates; 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, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA 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 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 the 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.

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SOURCE Windtree Therapeutics, Inc.