Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38898 Applied Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-3405262 (State ...

Core Viewpoint - Applied Therapeutics, Inc. reported its financial results for the fourth quarter and full year ended December 31, 2024, highlighting key leadership appointments and ongoing development programs for its lead drug candidate, govorestat, aimed at addressing unmet medical needs in rare diseases [1][2]. Leadership Appointments - John H. Johnson was appointed as Executive Chairman, and Les Funtleyder was named Interim Chief Executive Officer [5]. - Todd F. Baumgartner, MD, MPH was appointed as Chief Regulatory Officer, and Reena Thomas Colacot was appointed as Vice President and Head of Quality [5]. Development Programs - The company is focused on regulatory interactions regarding govorestat for Classic Galactosemia and Sorbitol Dehydrogenase (SORD) Deficiency [2]. - A Complete Response Letter (CRL) was received from the FDA for the NDA submitted for govorestat for Classic Galactosemia, and the company is evaluating its response [5]. Financial Results - Cash and cash equivalents increased to $79.4 million as of December 31, 2024, from $49.9 million at the end of 2023 [5]. - Research and development expenses decreased to $48.7 million in 2024 from $53.9 million in 2023, primarily due to reduced clinical and drug manufacturing costs [5]. - General and administrative expenses rose to $56.0 million in 2024 from $20.6 million in 2023, largely due to increased commercial and legal expenses [5]. - The net loss for 2024 was $105.6 million, or $0.76 per share, compared to a net loss of $119.8 million, or $1.42 per share, in 2023 [5][12]. Revenue Overview - Total revenue for 2024 was $455,000, a decrease from $9.99 million in 2023, with no license revenue reported for the year [12].

Core Viewpoint - Applied Therapeutics, Inc. has filed a Form 12b-25 with the SEC for a late filing of its Annual Report on Form 10-K for fiscal year 2024, granting an automatic 15-day extension to file the report by April 15, 2025 [1] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel drug candidates targeting validated molecular pathways in rare diseases [3] - The lead drug candidate, govorestat, is an Aldose Reductase Inhibitor designed for treating central nervous system rare metabolic diseases, including Classic Galactosemia, SORD Deficiency, and PMM2-congenital disorder glycosylation [3] Filing Details - The Form 12b-25 allows the company additional time to finalize its financial statements, with the expectation to file the Form 10-K by April 15, 2025 [1] - The filing is accessible on the company's Investor Relations website under "SEC Filings" [2] - A subsequent announcement will be made to disclose the fourth quarter and full-year 2024 earnings results once the Form 10-K filing date is confirmed [2]

Core Insights - Applied Therapeutics, Inc. has appointed Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer to lead the company's global regulatory strategy [1][3] - Dr. Baumgartner brings over 35 years of experience in drug development and has successfully led 12 New Drug Applications and marketing authorizations [2] - The company is focused on advancing its lead drug candidate, govorestat, for the treatment of rare diseases [4] Company Overview - Applied Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel drug candidates targeting rare diseases [4] - The lead drug candidate, govorestat, is an Aldose Reductase Inhibitor aimed at treating CNS rare metabolic diseases [4] Leadership Background - Dr. Baumgartner previously served as Senior Vice President of Global Regulatory Affairs at Ovid Therapeutics, overseeing multiple development functions [2] - He has held senior roles at Acorda Therapeutics, Purdue Pharma, AstraZeneca Pharmaceuticals, and Bristol-Myers Squibb [2]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of Applied Therapeutics, Inc. during the specified class period of the upcoming lead plaintiff deadline on February 18, 2025 [1]. Group 1: Class Action Details - Investors who purchased Applied Therapeutics securities between January 3, 2024, and December 2, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by February 18, 2025 [3]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements in this area [4]. - The firm has secured significant settlements for investors, including over $438 million in 2019 and has been consistently ranked among the top firms for securities class action settlements since 2013 [4]. Group 3: Case Allegations - The lawsuit alleges that Applied Therapeutics made false and misleading statements regarding its clinical trial protocols, which created a false impression of compliance with good clinical practices [5]. - It is claimed that the company's failure to adhere to trial protocols posed a severe risk of rejection of trial data by the U.S. Food and Drug Administration (FDA) during the New Drug Application process [5].

Core Viewpoint - A class action securities lawsuit has been filed against Applied Therapeutics, Inc. due to alleged securities fraud affecting investors between January 3, 2024, and December 2, 2024 [1] Group 1: Case Details - On November 27, 2024, Applied Therapeutics announced it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for govorestat, indicating deficiencies in the clinical application [2] - Following the CRL announcement, the stock price of Applied Therapeutics dropped from $10.21 per share on November 26, 2024, to $8.57 on November 27, 2024, and further declined to $2.03 on November 29, 2024, and $1.75 on December 2, 2024, marking a total decline of over 80% [2] - After disclosing a "warning letter" from the FDA regarding clinical trial issues on December 2, 2024, the stock price fell further to $1.69 on December 3, 2024, and continued to decline to $1.38 on December 4, 2024, and $1.29 on December 5, 2024 [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until February 18, 2025, to request the Court to appoint them as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4]

Core Viewpoint - A securities class action lawsuit has been filed against Applied Therapeutics, Inc. for alleged misconduct related to its drug candidate, govorestat, during the Class Period from January 3, 2024, to December 2, 2024 [1][2]. Group 1: Lawsuit Details - The lawsuit was filed in the United States District Court for the Southern District of New York on behalf of investors who acquired Applied Therapeutics securities during the specified Class Period [1]. - The lead plaintiff deadline for the lawsuit is set for February 18, 2025 [1][3]. - The complaint alleges that the defendants made false or misleading statements and failed to disclose that Applied Therapeutics was not following trial protocols and good clinical practices, which posed a significant risk of FDA rejection of trial data [2]. Group 2: Lead Plaintiff Process - Investors in Applied Therapeutics can seek to be appointed as lead plaintiff representatives by the deadline of February 18, 2025, or choose to remain absent class members [3]. - The lead plaintiff will represent all class members in directing the litigation and is typically the investor or group of investors with the largest financial interest [3]. Group 3: Firm Background - Kessler Topaz Meltzer & Check, LLP is known for prosecuting class actions and has a reputation for recovering billions for victims of corporate misconduct [4]. - The firm aims to protect investors and others from fraud and negligence by businesses [4].

Core Viewpoint - The news highlights a class action lawsuit against Applied Therapeutics, Inc. due to significant stock price declines following the issuance of a Complete Response Letter (CRL) from the FDA regarding its lead drug candidate, govorestat [2][3]. Group 1: Company Overview - Applied Therapeutics, Inc. is facing legal action from shareholders who purchased shares during the class period from January 3, 2024, to December 2, 2024 [2]. - The company’s stock price experienced a dramatic decline of over 80%, dropping from $10.21 per share on November 26, 2024, to $1.75 per share by December 2, 2024 [2]. Group 2: Regulatory Issues - On November 27, 2024, Applied Therapeutics announced it received a CRL from the FDA, indicating deficiencies in the clinical application of its New Drug Application (NDA) for govorestat [2]. - Following the CRL announcement, the company disclosed a "warning letter" from the FDA on December 2, 2024, which further impacted investor confidence and stock price [2]. Group 3: Shareholder Actions - Shareholders are encouraged to register for the class action lawsuit by February 18, 2025, to potentially be appointed as lead plaintiffs [3]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [3].

Group 1 - The Rosen Law Firm is reminding purchasers of Applied Therapeutics, Inc. securities of the lead plaintiff deadline on February 18, 2025, for a class action lawsuit [1] - Investors who purchased securities during the specified class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties can join by contacting the Rosen Law Firm [3][6] Group 2 - The lawsuit alleges that Applied Therapeutics made false and misleading statements regarding its clinical trial protocols, which created a risk of FDA rejection of trial data [5] - The firm has a strong track record in securities class actions, having achieved significant settlements and recognition in the legal field [4]

Core Viewpoint - A securities class action lawsuit has been filed against Applied Therapeutics, Inc. for alleged misconduct related to its drug candidate, govorestat, during the Class Period from January 3, 2024, to December 2, 2024 [1][3]. Group 1: Lawsuit Details - The lawsuit was filed in the United States District Court for the Southern District of New York [1]. - The lead plaintiff deadline for investors is set for February 18, 2025 [1][4]. - The complaint alleges that Applied Therapeutics made false or misleading statements and failed to disclose non-compliance with trial protocols, risking FDA rejection of trial data [3]. Group 2: Investor Information - Investors who suffered losses can seek to be appointed as lead plaintiffs or remain absent class members [4]. - The lead plaintiff represents the interests of all class members and selects counsel for the litigation [4]. - Kessler Topaz Meltzer & Check, LLP encourages affected investors to contact them for more information [5].