Core Insights - Aardvark Therapeutics has aligned with the FDA to lower the minimum age for pediatric patients in the Phase 3 HERO trial of ARD-101 from 13 to 10 years, expanding the eligible population for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS) [1][3] - New preclinical data presented at ObesityWeek 2025 highlights the potential of ARD-201 in enhancing glucose control and preserving lean body mass, addressing significant challenges in obesity treatment [2][4] - Aardvark reported $126.4 million in cash and short-term investments as of September 30, 2025, which is projected to support operations into 2027 [1][9] Clinical Program Updates - The HERO trial for ARD-101 has commenced enrollment with the new age eligibility of 10 years, broadening the target market for PWS [3] - Aardvark plans to advance ARD-201 into two Phase 2 trials, POWER and STRENGTH, to further evaluate its efficacy in metabolic obesity [2][4] Financial Highlights - Research and development expenses increased to $13.7 million for the quarter ended September 30, 2025, compared to $4.1 million in the same quarter of 2024, primarily due to higher development costs for ARD-101 [9] - General and administrative expenses rose to $4.0 million for the quarter ended September 30, 2025, from $1.0 million in the same quarter of 2024, reflecting increased personnel and operational costs [9] - The net loss for the quarter ending September 30, 2025, was $16.3 million, compared to $4.2 million for the same period in 2024, driven by increased operating expenses [9][12]

Core Insights - Aardvark Therapeutics, Inc. is set to present at ObesityWeek 2025, showcasing its innovative approaches to treating metabolic diseases, particularly obesity [1][2] Presentation Details - Aardvark will present two key studies on November 4, 2025: - The first study focuses on TAS2R Pan-Agonist ARD-101, which has shown to reduce weight gain in mice and decrease hunger in adults with obesity [2] - The second study discusses an isoflavonoid modulator of oxidative metabolism (WE-868) with potential therapeutic applications in obesity and diabetes [2] Investor Engagement - An investor webinar is scheduled for November 5, 2025, where Aardvark will discuss data from ObesityWeek, featuring insights from key opinion leaders in obesity drug development and discussions on ARD-101's application in Prader-Willi Syndrome [3] Product Overview: ARD-101 - ARD-101 is a gut-restricted small molecule that acts as a pan-agonist for bitter taste receptors, stimulating the release of gut-peptide hormones like GLP-1 and CCK, which are crucial for hunger regulation [4] - The FDA has granted ARD-101 Orphan Drug Designation and Rare Pediatric Disease Designation for its use in Prader-Willi Syndrome [4] Product Overview: ARD-201 - ARD-201 is a fixed-dose combination of a DPP-4 inhibitor and ARD-101, designed to enhance the body's natural signals for fullness by prolonging the activity of gut hormones [6] - Aardvark is advancing ARD-201 in two Phase 2 trials: - The POWER trial aims to prevent weight regain in subjects who stop GLP-1RA therapy after significant weight loss [7] - The STRENGTH trial will evaluate the potential for placebo-adjusted weight loss and the additive effects of ARD-201 with GLP-1RA therapy [7] Product Overview: WE-868 - WE-868 is a novel small molecule that modulates mitochondrial energy metabolism and is currently under preclinical evaluation for obesity and diabetes treatment [8] Company Background - Aardvark Therapeutics is focused on developing small-molecule therapeutics to suppress hunger, particularly for conditions like Prader-Willi Syndrome and other metabolic diseases [9] - The company aims to address limitations of existing GLP-1 therapies through its innovative product pipeline [9]

Company Overview - Akero Therapeutics is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Upcoming Events - Management will present at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 2:40 p.m. E.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2] Clinical Development - Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations with MASH [3] - The Phase 3 SYNCHRONY program builds on results from two Phase 2b clinical trials: the HARMONY study and the SYMMETRY study [3]

Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Clinical Development - The lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations affected by MASH [3] - The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials: the HARMONY study for pre-cirrhotic MASH and the SYMMETRY study for compensated cirrhosis due to MASH [3] Upcoming Events - Management will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 8:45 a.m. P.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2]

Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Upcoming Events - Management will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 1:40 p.m. P.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2] Clinical Development - Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations with MASH [3] - The Phase 3 SYNCHRONY program builds on results from two Phase 2b clinical trials: the HARMONY study and the SYMMETRY study [3]