Financial Performance - The company has incurred significant net losses, with an accumulated deficit of 9.3 million and 10.5 million, compared to 10.5 million [125]. - The company reported a net loss of 2.2 million in Q1 2024 [138]. - The accumulated deficit as of March 31, 2025, was 87.5 million from the sale of 6,120,661 shares at an IPO price of 129.1 million in gross proceeds from the sale of convertible preferred stock prior to its IPO in February 2025, which generated net proceeds of 16.00 per share [130]. - Net cash provided by financing activities was 91.1 million from the IPO [140]. Cash and Investments - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling 151.3 million as of March 31, 2025, which is expected to fund operations into 2027 [131]. - Net cash used in operating activities increased to 2.2 million in Q1 2024, primarily due to a reported net loss of 112.6 million in Q1 2025, mainly due to the purchase of short-term investments [139]. Research and Development - The company has no products approved for sale and does not expect to generate revenue until regulatory approval is obtained for its product candidates [105]. - The lead product candidate, ARD-101, is currently in a Phase 3 clinical trial for hyperphagia associated with Prader-Willi Syndrome, with topline data anticipated in early 2026 [96]. - The company has focused on developing small-molecule therapeutics targeting Bitter Taste Receptors (TAS2Rs) to alleviate hunger, with ongoing research into additional product candidates [96]. - The company plans to continue its development of ARD-101 and other candidates, conduct ongoing clinical trials, and expand its clinical management and regulatory capabilities [107]. - Research and development (R&D) expenses for the three months ended March 31, 2025, were 6.5 million increase from $1.2 million in the same period of 2024, primarily due to increased external costs related to ARD-101 [126]. - The company anticipates substantial increases in R&D expenses as it continues ongoing R&D activities and clinical trials for its product candidates [116]. Operational Strategy - The company relies on third parties for the manufacture of its product candidates and plans to maintain this strategy to focus on research and development [106]. - The company expects to incur significant commercialization expenses if regulatory approval is obtained for its product candidates [103]. Economic and Market Conditions - Macroeconomic conditions, including inflation and geopolitical conflicts, may negatively impact the company's financial position and growth prospects [110]. - The impact of foreign currency costs on operations has been negligible, with no formal hedging program in place [146]. - Inflation has not had a material effect on the company's results of operations during the periods presented [147]. Future Outlook - Future capital requirements are uncertain and depend on various factors, including the costs and timing of clinical trials and regulatory approvals [134]. - The company does not believe that a hypothetical 100 basis point change in interest rates would have a material impact on its financial statements [145]. - There have been no material changes to contractual obligations and other commitments as of March 31, 2025 [141]. - The company continues to evaluate its critical accounting estimates and policies, with no material changes reported [144].
Aardvark Therapeutics Inc(AARD) - 2025 Q1 - Quarterly Report