APLT Applied Therapeutics Inc

Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately. Mr. Hooks joins Applied with over 30 years of biopharmaceutical experience in rare disease marketing and sales, holding various leadership roles. Mr. Hooks will be responsible for leading Applied’s commercial preparations for the potential launch of govorestat for the treatment of Classic Galactosemia and SORD.

“I am pleased to welcome Dale to Applied, particularly at this critical stage in the company’s lifecycle as we approach the govorestat potential approval and launch,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “As we move towards becoming a commercial stage organization, we are committed to building out a strong and credentialed leadership team with experience launching rare disease therapies. I believe that Dale’s breadth of experience in commercial leadership roles and proven track record with product launches will be invaluable in bringing Applied from a development company to a commercial organization.”

Mr. Hooks has overseen over 20 new product launches in his career with over 30 years of industry experience. Most recently, he served as Vice President, Global Commercial Operations at Reata Pharmaceuticals, from 2019 until its acquisition by Biogen in 2023, where he led the launch of Skyclarys®, developing US and ex-US sales and commercialization strategies and overseeing early access programs. Previously, Mr. Hooks served in several commercial roles of increasing responsibility at Genentech, most recently as Franchise Head, Oncology. During his tenure at Genentech, he launched several new products and built multiple commercial franchises up to support new approvals. Mr. Hooks has also held leadership and commercial roles at Galderma Laboratories, Novartis Pharmaceuticals, and Glaxo Wellcome, now part of GSK. Mr. Hooks received a BBA from Stephen F. Austin University and an MBA from the University of North Carolina at Chapel Hill.

“I am excited to join Applied Therapeutics as the company nears significant and transformative milestones,” said Mr. Hooks. “Govorestat has the potential to become the first and only treatment option for patients living with debilitating rare diseases. With registrational filings under review in the US and in Europe, this is a critical year for the company. Applied’s progress to date has been impressive and I look forward to working with the team to further its momentum with a primary focus on bringing govorestat to patients.”

About Applied Therapeutics

Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. 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 Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of Diabetic retinopathy.

To learn more, please visit www.appliedtherapeutics.com and follow the company on Twitter @Applied_Tx.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.

Such risks and uncertainties include, without limitation, (i) our plans to develop, market and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain and establish collaborations or obtain additional funding, (vii) our ability to obtain and timing of regulatory approval of our current and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation of our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights, (xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating to our competitors and our industry, (xviii) our ability to achieve the anticipated benefits from the agreements entered into in connection with our partnership with Advanz Pharma and (xiv) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Investors:Maeve Conneighton (212) 600-1902 orappliedtherapeutics@argotpartners.com

Media:media@appliedtherapeutics.com