Core Viewpoint - Bright Minds Biosciences Inc. has initiated its Prader-Willi Syndrome (PWS) program and nominated BMB-105 as a new clinical candidate, aiming to address the unmet medical needs of patients with PWS through innovative treatment options [1][4][19]. Company Updates - The company will host a webcast on November 6, 2025, to discuss the Phase 2a study (NOVA Study) assessing the efficacy, safety, and tolerability of BMB-101 for PWS treatment [1][11]. - Key Opinion Leaders (KOLs) participating in the call include experts in the field of PWS, who will discuss the current therapeutic landscape and the challenges faced by patients and families [1][5]. - BMB-101 has shown strong pre-clinical and clinical rationale as a 5-HT2C agonist, potentially being the first on-target mechanism to address both neuropsychiatric symptoms and hyperphagia associated with PWS [1][4]. Clinical Development - Following the ongoing Phase 2a proof-of-pharmacology study with BMB-101, Bright Minds plans to advance BMB-105 as the dedicated compound for the PWS program, which is expected to reduce the time to market by approximately one year [2]. - The NOVA clinical study is designed as a double-blind, randomized Phase 2a study lasting up to 16 weeks, with a focus on assessing hyperphagia-related behaviors in patients with PWS [12][16]. - BMB-101 has been well tolerated in previous studies, with no serious adverse events reported, supporting its continued development [6][15]. About Prader-Willi Syndrome - PWS is a rare genetic neurodevelopmental disorder affecting approximately one in every 15,000 live births, characterized by hyperphagia and significant neurobehavioral challenges [13][14]. - Current treatments for PWS are inadequate, highlighting the need for novel therapeutic approaches that can effectively address both the physical and psychological aspects of the disorder [4][14]. About Bright Minds - Bright Minds is focused on developing innovative treatments for neurological and psychiatric disorders, with a pipeline that includes novel compounds targeting key receptors in the brain [19][20]. - The company aims to deliver breakthrough therapies that can transform the lives of patients suffering from conditions with high unmet medical needs, including epilepsy and PWS [19].

Table of Contents As filed with the Securities and Exchange Commission on February 6, 2025 Registration No. 333-284440 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act Of 1933 AARDVARK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 82-1606367 (Primary Standard Industrial Classification Code Number) (I.R.S. E ...