Financial Performance - The company has incurred significant net losses, with an accumulated deficit of $67.6 million as of March 31, 2025, and net losses of $9.3 million and $2.2 million for the three months ended March 31, 2025, and 2024, respectively [103]. - The total operating expenses for the three months ended March 31, 2025, were $10.5 million, compared to $2.2 million in 2024, resulting in a loss from operations of $10.5 million [125]. - The company reported a net loss of $9.3 million in Q1 2025, compared to a net loss of $2.2 million in Q1 2024 [138]. - The accumulated deficit as of March 31, 2025, was $67.6 million, with expectations of continued losses for the foreseeable future [133]. Funding and Capital - The company completed its IPO in February 2025, raising approximately $87.5 million from the sale of 6,120,661 shares at an IPO price of $16.00 per share [104]. - The company raised a total 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 $87.5 million from the sale of 6,120,661 shares at an IPO price of $16.00 per share [130]. - Net cash provided by financing activities was $88.9 million in Q1 2025, primarily from proceeds of $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, which is expected to fund operations into 2027 [104]. - The company had cash, cash equivalents, and short-term investments of $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 $11.4 million for Q1 2025 from $2.2 million in Q1 2024, primarily due to a reported net loss of $9.3 million [138]. - Net cash used in investing activities was $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 $7.8 million, a $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