On April 14, 2025 Applied Therapeutics, Inc. (Nasdaq: APLT) (the "Company"), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Applied Therapeutics, APR 14, 2025, View Source [SID1234651931]).
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"We remain focused on preparing for potential regulatory interactions regarding govorestat in both Classic Galactosemia and Sorbitol Dehydrogenase ("SORD") Deficiency," said Les Funtleyder, Interim CEO and CFO of Applied Therapeutics. "As we continue to optimize our strategy for our late-stage programs, we have also made key senior appointments across regulatory, medical and quality affairs functions to bolster our capabilities. We are confident in the promise of govorestat across indications and remain committed to our mission of addressing the unmet needs of patients with rare diseases."
Recent Highlights
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Appointed John H. Johnson as Executive Chairman and Les Funtleyder as Interim Chief Executive Officer. In December 2024, the Company appointed John H. Johnson as Executive Chairman of its Board of Directors. 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. In connection with Mr. Johnson’s appointment, the Company appointed Les Funtleyder, Chief Financial Officer of the Company, as Interim Chief Executive Officer.
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Appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer and Reena Thomas Colacot as Vice President and Head of Quality. In March 2025, the Company appointed Todd F. Baumgartner, MPD, MPH as Chief Regulatory Officer to lead the Company’s global regulatory strategy. Dr. Baumgartner joins the Company with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. In January 2025, the Company appointed Reena Thomas Colacot as Vice President and Head of Quality, where she is responsible for overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. Ms. Colacot brings over 25 years of quality leadership experience across the biopharmaceutical and medical device industries.
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Continued Review of Govorestat Development Programs for Classic Galactosemia and SORD Deficiency. As previously disclosed, the Company received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") for the New Drug Application ("NDA") submitted for govorestat for the treatment of Classic Galactosemia. The Company continues to evaluate its response to the CRL, including any meeting request to discuss appropriate next steps with the FDA regarding the path forward for govorestat for the treatment of Classic Galactosemia. The Company also continues to closely examine the ongoing govorestat development program for the potential treatment of SORD Deficiency and will continue to work with the FDA on the data needed to support an appropriate regulatory pathway, including ongoing work to provide the FDA with support for the potential use of the accelerated approval pathway for SORD Deficiency.
Financial Results
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Cash and cash equivalents totaled $79.4 million as of December 31, 2024, compared with $49.9 million at December 31, 2023.
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Research and development expenses for the year ended December 31, 2024, were $48.7 million, compared to $53.9 million for the year ended December 31, 2023. The decrease of approximately $5.2 million was primarily related to a decrease in clinical, pre-clinical and drug manufacturing and formulation costs, offset by an overall increase in regulatory, personnel and stock-based compensation expenses.
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General and administrative expenses were $56.0 million for the year ended December 31, 2024, compared to $20.6 million for the year ended December 31, 2023. The increase of approximately $35.4 million was primarily related to an increase in commercial, legal and professional, data storage, personnel and stock-based compensation expense, offset by an overall decrease in insurance expense.
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Net loss for the year ended December 31, 2024, was $105.6 million, or $0.76 per basic and diluted common share, compared to a net loss of $119.8 million, or $1.42 per basic and diluted common share, for the year ended December 31, 2023.