Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-42513 AARDVARK THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 82-1606367 | | --- | --- | ...

Aardvark Therapeutics Reports Second Quarter 2025 Financial Results and Provides Pipeline and Business Updates SAN DIEGO, CA, August 13, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small- molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today reported financial results for the second quarter ended June 30, 2025, and provided pipeline and business u ...

Core Insights - Aardvark Therapeutics, Inc. is advancing its clinical pipeline with significant progress in its lead compounds ARD-101 and ARD-201, targeting metabolic diseases and obesity [2][4][7] Clinical Program Updates - The Phase 3 HERO trial for ARD-101 will expand to include patients under 13 years old, aiming to address hyperphagia associated with Prader-Willi Syndrome (PWS) [3][7] - ARD-201, an oral obesity therapy, has shown promising preclinical results in reducing body weight and preventing weight regain after discontinuation of GLP-1 receptor agonist therapy, leading to its advancement in two Phase 2 trials: POWER and STRENGTH [4][7] Business Highlights - Aardvark has strengthened its leadership team with key appointments in scientific, commercial, regulatory, and legal roles, enhancing its operational capabilities [6] - The company reported a cash position of $141.8 million as of June 30, 2025, which is expected to support operations into 2027 [7][13] Financial Performance - For the second quarter of 2025, Aardvark reported research and development expenses of $13.1 million, a significant increase from $4.0 million in the same quarter of 2024, primarily due to higher development costs for ARD-101 [13] - The net loss for the quarter was $14.4 million, compared to a net loss of $5.4 million in the prior year, reflecting increased operational expenses [13][16]

Company Overview - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics for metabolic diseases [4] - The company is developing treatments specifically designed to suppress hunger, targeting conditions such as Prader-Willi Syndrome (PWS) and hypothalamic obesity [4] Recent Developments - Between July 8-14, 2025, Aardvark granted inducement awards consisting of stock options to two new employees, totaling 10,372 shares of common stock [1] - The stock options were granted under the Aardvark Therapeutics, Inc. 2025 Inducement Equity Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4) [2] Stock Options Details - The exercise prices for the options were set at $13.04 and $12.11, corresponding to the closing prices of Aardvark's common stock on the grant dates [3] - The options will vest over four years, with 25% vesting on the one-year anniversary of employment and the remaining shares vesting monthly thereafter, contingent on continued employment [3] Product Pipeline - Aardvark's lead compound, oral ARD-101, is currently in Phase 3 clinical development for treating hyperphagia associated with PWS [4] - The company is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, aimed at addressing limitations of existing GLP-1 therapies for obesity and related conditions [4]

Company Overview - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel small-molecule therapeutics aimed at activating innate homeostatic pathways for treating metabolic diseases, particularly Prader-Willi Syndrome (PWS) [1][4] - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS, a rare disease characterized by insatiable hunger [4] Conference Participation - Aardvark will participate in the 2025 United in Hope Conference, engaging with the PWS community and presenting data from its Phase 2 study of ARD-101 [1][2] - The presentations will include a poster and a five-minute oral presentation titled "Reduction in Hyperphagia in the ARD-101 Phase 2 Clinical Trial Informs Phase 3 HERO Trial in PWS," highlighting ARD-101's favorable safety profile and early evidence for reduced hyperphagia [2][3] Ongoing Studies - The company is currently enrolling patients in the ongoing Phase 3 HERO study, which is informed by the data from the Phase 2 study [2][3] - Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, aimed at addressing limitations of currently marketed GLP-1 therapies for obesity and related conditions [4]

Core Viewpoint - Aardvark Therapeutics, Inc. (AARD) shows significant upside potential with a mean price target of $31.25, indicating an 180.8% increase from the current price of $11.13 [1] Price Targets and Analyst Consensus - The average price targets from analysts range from a low of $20 to a high of $50, with a standard deviation of $13.05, suggesting variability in estimates [2] - The lowest estimate indicates a potential increase of 79.7%, while the highest suggests a 349.2% upside [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction [9] Earnings Estimates and Analyst Optimism - Analysts have shown increasing optimism about AARD's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 4.7%, with two estimates moving higher and no negative revisions [12] - AARD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

Summary of Aardvark Therapeutics (AARD) Conference Call Company Overview - **Company**: Aardvark Therapeutics (AARD) - **Focus**: Development of ARTOR 101, a therapeutic targeting appetite regulation through gut hormones Key Points Therapeutic Mechanism and Approach - ARTOR 101 was developed to inhibit bitter taste receptors to suppress appetite, initially theorized to reduce calorie intake by using a bitter compound that is non-toxic [3][4] - The drug stimulates the release of gut peptide hormones such as CCK, GLP-1, GLP-2, and possibly PYY, which act locally and are rapidly degraded [5][6] - The distinction between hunger (pain avoidance pathway) and appetite (pleasure-seeking pathway) is emphasized, with ARTOR 101 allowing users to skip meals without feeling hungry [8][9][12] Indication and Market Opportunity - The primary indication is for Prader-Willi syndrome, characterized by hyperphagia, which severely impacts patients and families [18][19] - Recent approval of Celino Therapeutics' drug VICAT (DCCR) for hyperphagia presents competition, but Aardvark believes their approach directly addresses the cause of hyperphagia, offering a significant market opportunity [20][21] Clinical Trials and Data - A phase two trial showed a drop of nine points on the HQCT scale, indicating a robust signal of efficacy [23][24] - The phase three trial design includes dose escalation and stricter inclusion criteria to ensure a more reliable data package [36][39] - The trial aims for a clinically meaningful change of five points on the HQCT scale, with 90% power requiring 32 patients per arm [46][47] Regulatory Pathway - The FDA indicated that one statistically significant study could suffice for submission as a pivotal trial [54][55] - Ongoing safety data collection from open-label extensions and additional trials in hypothalamic obesity and general obesity [55] Competitive Landscape - Aardvark anticipates that ARTOR 101 will replace rather than combine with existing treatments due to pricing and efficacy concerns [57][58] - The company is aware of the challenges faced by existing treatments, with a significant dropout rate observed in Celino's studies, indicating potential limitations in efficacy [58][59] Future Directions - Plans to explore hypothalamic obesity and general obesity, leveraging the drug's mechanism to enhance CCK signaling to the hypothalamus [61][63] - A trial comparing ARTOR 101 with GLP-1 drugs is planned to assess weight loss potential and rebound effects post-treatment [65][66] Additional Insights - The importance of consistent patient rating for HQCT scale assessments was highlighted, as variability can affect data reliability [38] - The potential for ARTOR 101 to suppress ghrelin levels, which rise with GLP-1 treatments, could provide a unique advantage in managing weight rebound [67] This summary encapsulates the key discussions and insights from the Aardvark Therapeutics conference call, focusing on the company's innovative approach to appetite regulation and the clinical and market strategies moving forward.

Financial Data and Key Metrics Changes - Aardvark Therapeutics recently completed its IPO in February 2025, raising approximately $150 million, which is expected to fund operations until 2027 [2][3] Business Line Data and Key Metrics Changes - The company is focusing on three indications: Prader Willi syndrome, hypothalamic obesity, and general obesity, with ongoing clinical trials for these conditions [11][12] - A pivotal phase three trial for Prader Willi syndrome is currently enrolling patients, with additional trials for hypothalamic obesity and general obesity expected to start in 2025 or 2026 [11][12] Market Data and Key Metrics Changes - The market for Prader Willi syndrome is estimated to have around 25,000 patients in the U.S., with a potential multibillion-dollar market opportunity, especially following the pricing of a competitor's product at $450,000 per year [12] Company Strategy and Development Direction - Aardvark Therapeutics aims to address the hunger axis of calorie intake through its drug, which targets the dysfunctional hunger signal in patients [10][11] - The company is also exploring a combination product that includes a DPP-4 inhibitor to enhance weight loss and metabolic benefits [37][48] Management's Comments on Operating Environment and Future Outlook - Management believes that the regulatory benchmark for weight loss approval remains at 5% placebo-adjusted weight loss, which aligns with the health benefits observed in patients [58] - The company is confident in its unique mechanism of action compared to GLP-1 drugs, suggesting potential for synergistic effects when used in combination [58] Other Important Information - The company has a clean safety profile from its phase one studies, with no adverse events reported, indicating a low risk of side effects due to the drug's localized action in the gut [18][19] - Aardvark is implementing strict controls in its phase three trial design to mitigate the impact of external factors on study outcomes [27][28] Q&A Session Summary Question: What is the current status of the regulatory outlook regarding placebo-adjusted weight loss? - The FDA has confirmed that a 5% weight loss is the benchmark for approvability, as it correlates with significant health benefits [58] Question: How does Aardvark's drug compare to GLP-1 drugs? - Aardvark's management emphasizes that their drug operates through a different mechanism and may be used synergistically with GLP-1 drugs, focusing on achieving the 5% weight loss benchmark while ensuring a better safety profile [58]

Core Insights - Aardvark Therapeutics, Inc. has appointed key members to its leadership team to enhance its strategic capabilities as it progresses with its Phase 3 HERO study of ARD-101 for treating hyperphagia associated with Prader-Willi Syndrome [1][2] Leadership Appointments - Timothy Kieffer, Ph.D., appointed as Chief Scientific Officer, brings extensive experience in diabetes mechanisms and translational medicine, having previously served at ViaCyte Inc. and Fractyl Health [2][3] - Danny Villeneuve appointed as Chief Commercial Officer, has over 20 years of commercial leadership experience in the biopharmaceutical industry, notably leading the relaunch of a flagship ADHD product at Ironshore Pharmaceuticals [3] - Terrie Kellmeyer, Ph.D., appointed as Senior Vice President, Regulatory Affairs, has nearly 30 years of regulatory strategy and clinical development expertise, contributing to multiple successful New Drug Applications [4] - Christian Zapf, J.D., appointed as General Counsel, has over 20 years of legal and transactional experience in biotechnology, previously serving at Abpro Corporation and NantWorks [5] Company Overview - Aardvark is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics to suppress hunger for treating Prader-Willi Syndrome and other metabolic diseases [8] - The lead compound, ARD-101, is in Phase 3 clinical development for hyperphagia associated with PWS and is also being studied for hypothalamic obesity [8]

Core Viewpoint - Aardvark Therapeutics, Inc. has announced the appointment of key leadership members to enhance its expertise and strategic insight as it progresses with its Phase 3 HERO study of ARD-101 for treating hyperphagia associated with Prader-Willi Syndrome [2] Leadership Appointments - Timothy Kieffer, Ph.D., appointed as Chief Scientific Officer, brings extensive experience in diabetes mechanisms and translational medicine, having previously served as Chief Scientific Officer at ViaCyte Inc. and Fractyl Health [2][3] - Danny Villeneuve appointed as Chief Commercial Officer, has over 20 years of commercial leadership experience in the biopharmaceutical industry, including a successful tenure at Ironshore Pharmaceuticals [3] - Terrie Kellmeyer, Ph.D., appointed as Senior Vice President, Regulatory Affairs, has nearly 30 years of regulatory strategy and clinical development expertise, contributing to multiple successful New Drug Applications [4] - Christian Zapf, J.D., appointed as General Counsel, has over 20 years of legal and transactional experience in biotechnology, previously serving at Abpro Corporation and NantWorks [5] Company Overview - Aardvark is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics to suppress hunger for treating Prader-Willi Syndrome and metabolic diseases, with its lead compound ARD-101 in Phase 3 clinical development [8] - The company is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, aimed at addressing limitations of current GLP-1 therapies for obesity [8] Inducement Grants - On May 16, 2025, Aardvark granted options to purchase an aggregate of 137,500 shares of common stock to two new employees, with an exercise price of $9.89, the closing price on the grant date [7]