SAN DIEGO, Oct. 08, 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, announces alignment with the U.S. Food and Drug Administration (FDA) on a protocol amendment to the company’s Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS). The protocol ...

Summary of Aardvark Therapeutics Conference Call Company Overview - Aardvark Therapeutics is a San Diego-based biotech company focused on developing small molecule oral drugs aimed at regulating eating behavior, particularly through gut-brain signaling [2][4] Core Product: ARD-101 - ARD-101 is designed to release gut peptide hormones to suppress hunger rather than appetite, targeting conditions like Prader-Willi syndrome and general obesity [2][5] - The drug is gut-restricted, with 99% remaining in the gut, activating taste receptors on enteroendocrine cells to trigger hormone release that dampens appetite [5][6] Mechanism of Action - The drug targets both reward-based and hunger-driven eating behaviors, with a unique approach of activating anti-hunger pathways [4][5] - Ghrelin levels in Prader-Willi patients can be up to 4 times higher than normal, indicating a strong hunger drive, which ARD-101 aims to address [10] Clinical Data and Phase 2 Study - The Phase 2 study involved 18 subjects with Prader-Willi syndrome over a 28-day treatment period, showing nearly 50% reduction in HQ-CT9 scores [28] - Anecdotal evidence included patients leaving food on their plates and forgetting meal times, which are significant behavioral changes for this population [29][36] - Body composition data indicated a 1.5% reduction in body fat and a 2% increase in lean body mass during the 28-day period [31] Phase 3 Study Design - The Phase 3 study has expanded inclusion criteria to include patients aged 13 and up, with plans to lower the age limit further [43] - The study design aims to mitigate placebo effects by implementing a second baseline assessment [44] - The trial is powered to detect a placebo-adjusted change of 4 points in HQ-CT, with a sample size of 45 patients per arm [45] Other Programs: ARD-201 - ARD-201 is a fixed-dose combination of ARD-101 and sitagliptin, showing promising results in animal models with a 19% weight loss [51] - The combination is expected to enhance the efficacy of ARD-101 by prolonging the action of gut peptide hormones [52] - A microdose of tirzepatide combined with ARD-201 resulted in a 30% weight reduction in diet-induced obese mice, indicating potential for significant weight loss in humans [53] Conclusion - Aardvark Therapeutics is positioned to address significant unmet needs in obesity and related disorders through innovative drug mechanisms and promising clinical data, with ongoing studies expected to provide further insights into the efficacy and safety of their products [54]

Core Insights - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics for metabolic diseases, particularly targeting hunger suppression in conditions like Prader-Willi Syndrome [3] Company Overview - Aardvark is developing oral compound ARD-101, currently in Phase 3 clinical development for hyperphagia associated with Prader-Willi Syndrome, a rare disease characterized by insatiable hunger [3] - The company is also working on 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 [3] Upcoming Events - Aardvark will present at the Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025, at 9:00 a.m. Eastern time, with a live webcast available on their website [1][2]

Aardvark Therapeutics FY Conference Summary Company Overview - Aardvark Therapeutics is a San Diego-based biotech company focused on developing small molecule oral drugs to manage hunger, with a lead program in phase 3 development for Prader-Willi syndrome [2][4]. Industry Context - Prader-Willi syndrome is a genetic disorder caused by a chromosome 15 abnormality, affecting approximately 10,000 to 20,000 patients in the U.S. and 300,000 to 400,000 worldwide. Patients experience extreme hunger, anxiety, systemic inflammation, and severe constipation [4][5]. Core Product: ARD-101 - ARD-101 is designed to activate taste receptors in the gastrointestinal tract, stimulating the release of hormones like GIP and GLP-1, which convey feelings of fullness and reduce hunger [7][9]. - The drug aims to differentiate itself by effectively managing hunger rather than appetite, addressing a significant unmet need in Prader-Willi syndrome treatment [14]. Clinical Data and Phase 2 Results - In a phase 2 study, 18 patients completed a 28-day treatment with ARD-101, showing a reduction of about 8 points on the HQCT-9 score, a validated measure of hunger in Prader-Willi patients [21][22]. - Anecdotal evidence suggested rapid onset of diminished hunger feelings and reductions in anxiety and inflammation [21][22]. Phase 3 HERO Trial - The HERO trial will compare ARD-101 to a placebo, focusing on the HQCT-9 score at week 12 as the primary endpoint [30]. - The trial will now include patients aged 13 and up, expanding the potential patient population [32]. - Enrollment is progressing well, with strong enthusiasm from investigators [34]. Safety and Tolerability - ARD-101 has a unique safety profile, being 99% gut-restricted, which minimizes systemic exposure and potential side effects [29]. - The drug's mechanism allows for physiological release of hormones, reducing concerns associated with chronic pharmacological levels seen in other treatments [16]. Competitive Landscape - Currently, there is only one approved drug for hyperphagia in Prader-Willi syndrome, indicating a significant market opportunity for ARD-101 [44]. - Aardvark Therapeutics believes its differentiated mechanism and safety profile will allow it to capture a substantial share of the market, particularly among patients who do not respond optimally to existing treatments [44]. Obesity Program: ARD-201 - ARD-201 combines ARD-101 with a DPP-4 inhibitor, aiming to extend the biological half-life of gut hormones and enhance weight loss efficacy [47]. - Preclinical studies showed promising results, including a 19% weight loss in obese mice within 30 days, comparable to GLP-1 receptor agonists [49]. - The POWER trial will explore the prevention of weight regain in patients transitioning off GLP-1 treatments, while the STRENGTH trial will assess prospective weight loss with ARD-201 [56][58]. Financial Position - Aardvark Therapeutics reported $141 million in cash, expected to fund operations into 2027, covering key clinical readouts from the HERO and POWER trials [63]. Macro Considerations - The company is aware of the competitive landscape, particularly with rising biotech innovation in China, but believes its late-stage development and unique safety profile position it well [65]. - Aardvark is leveraging AI in its R&D processes to enhance predictive modeling and study design [68][70]. Conclusion - Aardvark Therapeutics is advancing its innovative treatments for Prader-Willi syndrome and obesity, with promising clinical data and a strong financial position to support its ongoing trials and market entry strategies [63][64].

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 - On August 28, 2025, Aardvark granted inducement awards consisting of stock options to two new employees, totaling 20,013 shares of common stock [1] - The stock options were granted under the Aardvark Therapeutics, Inc. 2025 Inducement Equity Incentive Plan, in compliance with Nasdaq Listing Rule 5635(c)(4) [2] Stock Option Details - The exercise price for each option is set at $8.49, which is the closing price of Aardvark's common stock on the grant date [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 [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 [4]

Aardvark Therapeutics (AARD) 2025 Conference Summary Company Overview - Aardvark Therapeutics is a San Diego-based biotech company focused on small molecule drug development, specifically targeting gut-brain signaling pathways to mediate appetite regulation [3][4] Core Points and Arguments Drug Mechanism and Development - Aardvark's drug is a gut-restricted small molecule that signals the gut-brain pathway to reduce hunger by affecting enteroendocrine cells, which release gut peptide hormones [3][4][5] - The primary mechanism of action is believed to be through the vagal nerve, which communicates with the brain to regulate appetite [5][6] - The drug targets both hunger and appetite, with recent preclinical data showing effectiveness in general obesity beyond just Prader Willi syndrome [8][9][10] Clinical Trials and Results - Aardvark conducted a placebo-controlled trial with 20 patients for general obesity, showing a 1% greater weight loss in the treatment group compared to placebo [14] - Significant reductions in subjective hunger scores and ghrelin levels were observed, indicating the drug's effectiveness in appetite regulation [15] - In a diet-induced obesity mouse model, the ARD201 formulation resulted in a 19% weight loss over 30 days, comparable to the 20.5% weight loss seen with tirzepatide [22][23] Upcoming Trials - Aardvark is amending its Phase II program to focus on two new studies: the POWER trial (Prevention of Weight Regain) and the STRENGTH trial, both set to start before the end of 2025 [25][27] - The POWER trial will recruit patients who have lost at least 15% of their weight on GLP-1s, while the STRENGTH trial will compare the combination of Aardvark's drug with GLP-1s [27][30] Patient Population and Inclusion Criteria - The company plans to lower the age inclusion criteria for the Prader Willi program to potentially include patients as young as seven years old, aiming for a broader label if successful [42][44] - Recent updates allow for patients on concomitant atypical antipsychotics to participate, addressing previous concerns about trial purity [45][47] Market Position and Competitive Landscape - Aardvark anticipates competition from drugs like VICAD XR but believes its drug's side effect profile and early data will attract patient interest [59][60] - The company is focused on maintaining a strong enrollment rate for its trials despite the competitive landscape [60] Other Important Content - The drug's mechanism is designed to enhance the natural secretion of gut peptide hormones without reaching super-physiological levels, potentially reducing side effects like nausea [18][19] - Aardvark's approach to managing placebo effects includes a second baseline score assessment to ensure accurate measurement of treatment effects [52] - The company plans to share peer-reviewed publications and updates on trial progress over the next 12 to 18 months, with a presence at ObesityWeek in November [66]

Core Viewpoint - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at treating metabolic diseases, particularly through the activation of innate homeostatic pathways [1][2]. Company Overview - Aardvark is developing novel therapeutics to suppress hunger, specifically targeting conditions like Prader-Willi Syndrome (PWS) and other metabolic diseases [2]. - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS and is also being studied for hypothalamic obesity [2]. - Aardvark is also working on ARD-201, a fixed-dose combination of ARD-101 and a DPP-4 inhibitor, aimed at overcoming limitations of existing GLP-1 therapies for obesity and related conditions [2]. Upcoming Events - Aardvark will present at several conferences in September 2025, including: - Cantor Fitzgerald Global Healthcare Conference on September 3 at 11:30 a.m. ET [4]. - Morgan Stanley 23rd Annual Global Healthcare Conference on September 8 at 7:00 a.m. ET [4]. - H.C. Wainwright 27th Annual Global Investment Conference on September 10 at 10:30 a.m. ET [4]. - Live webcasts of these presentations will be available on the company's website, with archived recordings accessible for approximately one month post-event [1].

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]