Aardvark Therapeutics Reports Third Quarter 2025 Financial Results and Provides Pipeline and Business Updates

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]