NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the following leadership changes, effective immediately:
- John H. Johnson, a recognized leader in the pharmaceutical and biotechnology industry, has been named Executive Chairman;
- Dr. Shoshana Shendelman has stepped down as Chair and CEO; and
- Les Funtleyder, Applied Therapeutics’ Chief Financial Officer, has been named Interim Chief Executive Officer.
Mr. Johnson is a biopharmaceutical industry veteran with 40 years of transformational leadership experience at global healthcare organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone, and Pfizer, Inc. He brings to Applied Therapeutics a multi-decade track record of implementing turnaround plans that enable growth and value creation for shareholders. He has served as the CEO of Reaction Biology and before that served as CEO of Strongbridge Biopharma plc prior to its acquisition by Xeris Biopharma Holdings. He is also an experienced Director having served on numerous boards across biotech and biopharmaceutical services companies.
Dr. Teena Lerner, Applied Therapeutics’ Lead Independent Director, said, “On behalf of the Board, we strongly believe that John will be a tremendous addition to Applied Therapeutics. His experience leading pre-commercial businesses, deep knowledge of rare diseases and the commercialization process, along with his commitment to culture, are deeply aligned with Applied Therapeutics’ priorities. We believe this change in leadership is the right next step for our Company, our shareholders and the patients we aim to serve.”
Dr. Lerner continued, “Les has a strong understanding of our business and operations and has fostered relationships across our industry and the Applied Therapeutics team since resuming the role of CFO last year. Having served as a member of the Board since June 2016 and previously served as our interim CFO in 2018 and 2019, he brings to the interim CEO role deep knowledge of our company and extensive experience managing and investing in the healthcare industry. We are confident in Les and John’s ability to drive the Company forward and will continue to support them and the leadership team while we work to identify a permanent CEO.”
Mr. Johnson said, “I look forward to leveraging my background and years of biopharmaceutical experience to help write the next chapter for Applied Therapeutics. My top priority will be to ensure we have the right groundwork in place to work toward our regulatory and clinical milestones. I look forward to working closely with the Board, management and team to drive value creation.”
“I am honored to assume the role of Interim CEO and lead the Company forward,” said Mr. Funtleyder, “We have a deep bench of talent throughout the organization and a promising clinical pipeline. Utilizing our unique multifaceted approach to drug development, I am confident in our potential to bring the candidates in our pipeline to the patients who need them.”
“We thank Shoshana for her leadership and vision, which have been pivotal to developing Applied Therapeutics’ portfolio of highly specific and selective product candidates. We wish her the very best in her future endeavors,” concluded Dr. Lerner.
Dr. Shendelman said, “Founding and leading Applied Therapeutics for the last eight years has been an incredible journey. Together, we completed multiple successful clinical trials, built commercial infrastructure and advanced the Company’s Aldose Reductase Inhibitor (ARI) franchise across multiple disease areas.”
With the support of the Company’s finance organization, Mr. Funtleyder will continue to serve as CFO while serving as Interim CEO.
Business Updates
As previously disclosed, in November 2024, the Company received a Complete Response Letter (“CRL”) for the New Drug Application (NDA) for govorestat for the treatment of Classic Galactosemia. Given the leadership changes announced today, the Company continues to evaluate its response to the CRL, including any meeting request to discuss appropriate next steps with FDA.
Following receipt of the CRL, the Company also today announced the withdrawal of the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for govorestat (AT-007) for the treatment of Classic Galactosemia, as more time is needed to acquire further data to support a European MAA.
In light of recent regulatory developments, the Company will be closely examining the ongoing Sorbitol Dehydrogenase (SORD) Deficiency clinical development program and will continue to work with the FDA on the data needed to support an appropriate regulatory pathway for the drug, including ongoing work to provide the FDA with support for the potential use of the accelerated approval pathway for govorestat for the treatment of SORD Deficiency. To accommodate these ongoing workstreams, the Company currently expects to submit an NDA for govorestat for the treatment of SORD after the first quarter of 2025.
Mr. Funtleyder continued, “While we complete the important work to best position govorestat, we are focused on execution and ensuring the highest standards of integrity and quality. SORD Deficiency is a rare neuromuscular disease with no FDA-approved drugs, and it remains highly attractive in terms of unmet need, key opinion leader support and commercial potential. We continue to believe in the clinical value of govorestat and remain committed to the prospect of providing patients with a treatment option that has the potential to slow disease progression.”
Additionally, the Company announced that the Compensation Committee of the Board of Directors of the Company approved inducement awards to Mr. Johnson under Nasdaq Listing Rule 5635(c)(4) consisting of a stock option award to acquire 2,000,000 shares of our common stock and a restricted stock unit award with respect to 1,000,000 shares of our common stock. Fifty percent of each of these inducement awards will vest upon the earlier to occur of a change in control or the approval by the United States Food and Drug Administration (FDA) of the Company’s proposed new drug application relating to the treatment of Sorbitol Dehydrogenase Deficiency, with the remaining fifty percent of the inducement awards vesting in equal annual installments on each of the first two anniversaries of the grant date. Mr. Johnson must generally remain continuously employed through each vesting date.
About John H. Johnson
John H. Johnson, 66, is a recognized leader in the pharmaceutical and biotechnology industry, with more than four decades of experience. Currently, he serves as a member of the Board of Directors, member of the Compensation Committee and Chair of the Nominating and Corporate Governance Committee of Verastem, Inc. (Nasdaq: VSTM) since April of 2020. He has served as Chief Executive Officer and Board Director of Reaction Biology, since March of 2022, and a member of the Board of Directors of Xeris Biopharma Holdings, Inc. serving on the Nominating and Corporate Governance Committee and Axogen, Inc. serving on the compensation committee and chair of the Quality, Compliance, and Portfolio committee. He served from 2005-2007 as the Company Group Chairman of Biopharmaceuticals within Johnson & Johnson, responsible for the Biotechnology, Immunology, and Oncology commercial businesses. Previously, Mr. Johnson served from September 2009 to January 2011 as president of Eli Lilly & Company’s Worldwide Oncology Unit, following the company’s 2008 acquisition of ImClone Systems, Inc., where he served as Chief Executive Officer and a member of ImClone’s Board of Directors from August 2007 until October 2008. He has served as a member of the Board of Directors of Pharmaceutical Research and Manufacturers of America (PhRMA), from January 2013 until August 2014, and as a member of the Health Section Governing Board of biotechnology Industry Organization (BIO), from January 2013 to August 2014. Mr. Johnson also served as CEO of Strongbridge Biopharma plc, a rare disease company, from July 2020 until its acquisition by Xeris Biopharma Holding Inc. in October 2021.
About Les Funtleyder
Les Funtleyder, 55, has served as a member of our board of directors since June 2016 and since November 2023 has served as our Chief Financial Officer. Mr. Funtleyder has served as a healthcare portfolio manager at E Squared Capital Management, LLC since January 2014, a role from which he is currently taking a sabbatical, as a senior external advisor with McKinsey and Co. since June 2017, and as a consulting partner at Bluecloud Health, a private equity healthcare fund, from December 2013 to April 2020. Mr. Funtleyder previously served as the director of strategic investments and communications of OPKO Health Inc., a publicly traded healthcare company. Mr. Funtleyder currently serves on the board of directors of several private healthcare companies and foundations while also serving on the board of directors of Nasdaq-listed Reviva Pharmaceuticals (Nasdaq: RVPH) and as an advisor at Zentynel Frontier Investments. Mr. Funtleyder is an adjunct professor at Columbia University Medical Center and an adjunct professor of healthcare investors at the Columbia University School of Public Health. Mr. Funtleyder received his B.A. from Tulane University and MPH from Columbia University Mailman School of Public Health.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. The Company’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency and PMM2-congenital disorder glycosylation (CDG).
To learn more, please visit www.appliedtherapeutics.com.
