NEW YORK - Applied Therapeutics Inc . (NASDAQ:APLT), a biopharmaceutical company focusing on rare diseases, announced significant leadership changes and provided business updates. The company, currently valued at approximately $119 million, named industry veteran John H. Johnson as Executive Chairman while Dr. Shoshana Shendelman stepped down as Chair and CEO. Les Funtleyder, the company's CFO, has been appointed Interim CEO. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though its overall financial health score remains weak at 1.75 out of 10.
Dr. Teena Lerner, Applied Therapeutics' Lead Independent (LON:IOG) Director, expressed confidence in Johnson's ability to drive value creation for shareholders and in Funtleyder's understanding of the business to lead the company temporarily. The board is actively seeking a permanent CEO. The leadership transition comes as the stock trades near its 52-week low of $0.95, having declined about 77% over the past six months.
Johnson, with a 40-year history in the industry, has held leadership roles at notable healthcare organizations. He aims to focus on regulatory and clinical milestones for Applied Therapeutics. Funtleyder, who has been with the company's board since 2016, emphasized the potential of their clinical pipeline and the commitment to meeting patients' needs.
The company also addressed regulatory hurdles, revealing the withdrawal of its Marketing Authorization Application for govorestat in Europe and a delay in its New Drug Application submission to the FDA for the treatment of SORD Deficiency, now expected after Q1 2025. This follows a Complete Response Letter received in November 2024 for govorestat's use in treating Classic Galactosemia. InvestingPro analysis reveals that three analysts have recently revised their earnings expectations downward, with the company expected to remain unprofitable this year.
As part of the leadership compensation package, Johnson received inducement awards subject to certain conditions, including FDA approval of the company's drug application for SORD Deficiency.
Applied Therapeutics emphasized its dedication to advancing its drug candidate portfolio, particularly govorestat, which targets rare metabolic diseases. The company's focus remains on addressing unmet medical needs and upholding quality and integrity in its development processes. With analyst price targets ranging from $2 to $13, investors seeking deeper insights can access comprehensive analysis and 15 additional ProTips through InvestingPro's detailed research reports.
This news summary is based on a press release statement from Applied Therapeutics, Inc.
In other recent news, Applied Therapeutics faced a series of challenges and changes. The company's director has resigned, prompting a search for a replacement. Additionally, the company received a Complete Response Letter from the U.S. Food and Drug Administration, declining approval for its Classic Galactosemia drug, govorestat, due to clinical application deficiencies. Despite this setback, Applied Therapeutics plans to discuss potential resubmission or appeal options with the FDA.
Simultaneously, the company is developing a treatment for Sorbitol Dehydrogenase Deficiency, with a New Drug Application submission expected in 2025. Analysts from Baird and RBC Capital Markets have downgraded the company's stock, yet acknowledge the potential value in the company's SORD deficiency program.
On the financial front, Applied Digital Corporation reported a fiscal first quarter revenue of $60.7 million, marking a 67% increase year-over-year. The adjusted net loss was $21.6 million or $0.15 per share, which was better than the anticipated loss of $0.27 per share. Adjusted EBITDA stood at $20.0 million, a significant increase from the previous year. These are among the recent developments in Applied Therapeutics.
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