Windtree Appoints Randall White, Ph.D., as Vice President, Clinical Program Management

Rhea-AI Summary

Windtree Therapeutics (NasdaqCM: WINT) has appointed Randall White, Ph.D., as Vice President of Clinical Program Management. Dr. White brings over 20 years of pharmaceutical research experience, previously serving at Daiichi Sankyo and Bristol-Myers Squibb. His expertise will support Windtree's clinical development projects. To incentivize his employment, the company granted Dr. White a stock option for 100,000 shares at the closing price on the grant date. Windtree focuses on interventions for acute cardiovascular and pulmonary disorders, with key products including istaroxime and AEROSURF®.

Positive

• Appointment of Dr. Randall White may enhance leadership in clinical development.
• Dr. White's extensive experience in drug development could accelerate project timelines.

Negative

• Potential concerns about continuity in leadership, given Dr. White's new role.

WARRINGTON, Pa., Aug. 02, 2021 (GLOBE NEWSWIRE) -- 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 Randall White, Ph.D., as Vice President, Clinical Program Management, reporting to Steve Simonson, M.D., Senior Vice President and Chief Medical Officer of Windtree.

Dr. Randall White brings over 20 years of pharmaceutical research and development experience to the Windtree team. Most recently, he was the Executive Director and Global Team Leader of Quizartinib at Daiichi Sankyo, Inc, where he was responsible for leading clinical strategy and development as well as program execution. He also served as Chief of Staff Global Oncology R&D for several years. Prior to that, Dr. White was the Head of Project Management for the Early Immuno-Oncology portfolio at Bristol-Myers Squibb, where he drove strategy and project management oversight. While at BMS, he also project managed the initial global submission and approval for Opdivo^® in metastatic melanoma and supported key global brands such as Orencia® and Eliquis®. His earlier roles included Senior Project Manager at Sandoz Pharmaceuticals and Project Manager of Clinical Development at Protarga. Dr. White holds a Ph.D. from the University of Illinois, an M.S. from North Carolina State University, and a B.S. from Cornell University.

“We are thrilled to welcome Randy to the Windtree team," said Steve Simonson, M.D., Senior Vice President and Chief Medical Officer of Windtree. "Randy is a seasoned executive with decades of experience in drug development. His input will be extremely valuable as we progress multiple development projects forward.”

Dr. White commented, “I am honored to join the impressive team at Windtree in my new role on the clinical development team. I look forward to working with an exceptional company to advance an important pipeline of cardiology and pulmonary assets addressing significant unmet patient needs.”

In connection with Dr. White’s appointment, the Board of Directors of Windtree granted Dr. White 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, August 2, 2021. The stock option is being granted to Dr. White as an inducement material to his 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. White’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.

Contact Information:
Monique Kosse
LifeSci Advisors
212.915.3820 or monique@lifesciadvisors.com

Media contact:
Andrew Mielach
LifeSci Communications
646.876.5868 or amielach@lifescicomms.com

FAQ

Who is the new Vice President of Clinical Program Management at Windtree?

Randall White, Ph.D., has been appointed as Vice President of Clinical Program Management.

What experience does Randall White bring to Windtree?

Dr. White has over 20 years of experience in pharmaceutical research, including leadership roles at Daiichi Sankyo and Bristol-Myers Squibb.

What stock options were granted to Dr. White upon his appointment?

Dr. White was granted a stock option to purchase 100,000 shares at the closing price on August 2, 2021.

How could Dr. White's appointment impact Windtree's clinical development?

His extensive experience is expected to strengthen Windtree's ability to progress multiple development projects in cardiovascular and pulmonary treatments.