[Second Quarter 2025 Report Overview](index=1&type=section&id=Second%20Quarter%202025%20Report%20Overview) This report provides an overview of Aardvark Therapeutics' progress in clinical development, corporate updates, and financial performance for the second quarter of 2025 [Company Introduction & CEO Commentary](index=1&type=section&id=Company%20Introduction%20%26%20CEO%20Commentary) Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies to activate innate homeostatic pathways for metabolic diseases, with its CEO highlighting significant progress in ARD-101 and ARD-201 studies and plans to expand ARD-101's HERO Phase III trial - Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel small molecule therapies that activate innate homeostatic pathways to treat metabolic diseases[2](index=2&type=chunk) - Dr. Tien Lee, CEO of the company, stated that ARD-101 and ARD-201 have made significant progress in multiple studies, and plans are underway to expand the ARD-101 HERO Phase III trial to include younger PWS patients under 13 years of age[3](index=3&type=chunk) - Recent preclinical data from the ARD-201 obesity program reinforced the company's confidence in targeting hunger signaling pathways as a complementary approach to GLP-1RA therapies[3](index=3&type=chunk) [Key Highlights](index=1&type=section&id=Key%20Highlights) Key highlights include ARD-201 preclinical data supporting an optimized Phase II clinical development strategy for obesity, the planned expansion of ARD-101's HERO Phase III trial to children under 13, and **$141.8 million** in cash, cash equivalents, and short-term investments as of June 30, 2025, expected to fund operations into 2027 - Compelling preclinical data for ARD-201 informed an optimized Phase II clinical development strategy for the obesity program: the POWER Phase II trial will focus on weight regain in patients discontinuing GLP-1RAs, while the STRENGTH Phase II trial will assess sustained weight loss as monotherapy and in combination with GLP-1RAs[6](index=6&type=chunk) - The HERO Phase III trial of ARD-101 for PWS-related hyperphagia is expected to expand to include pediatric patients under 13 years of age[6](index=6&type=chunk) Cash and Short-Term Investments | Metric | Amount (Million USD) | | :--------------------------------- | :-------------- | | Cash, cash equivalents, and short-term investments (as of June 30, 2025) | 141.8 | | Expected operational support duration | 2027 | [Clinical Program Updates](index=1&type=section&id=Clinical%20Program%20Updates) This section details the latest advancements in Aardvark's clinical programs, including trial expansions and updated timelines for ARD-101 and ARD-201 [ARD-101 for Prader-Willi Syndrome (PWS)](index=1&type=section&id=ARD-101%20for%20Prader-Willi%20Syndrome%20%28PWS%29) Aardvark plans to expand the ARD-101 HERO Phase III trial for PWS-related hyperphagia to include younger patients under 13, a move supported by the PWS community and historical data suggesting greater benefit from earlier intervention - Aardvark plans to expand the ARD-101 HERO Phase III trial for PWS-related hyperphagia to include patients under 13 years of age[4](index=4&type=chunk) - This expansion is supported by the PWS community and historical data indicating that younger patients are more likely to benefit from earlier intervention[4](index=4&type=chunk) [ARD-201 for Obesity](index=1&type=section&id=ARD-201%20for%20Obesity) Recent preclinical data for ARD-201, an oral obesity therapy, demonstrated significant weight loss and effective prevention of weight regain after GLP-1RA discontinuation, leading Aardvark to advance two new Phase II trials: POWER and STRENGTH - Preclinical data released on August 12, 2025, showed that the oral obesity therapy ARD-201 not only significantly reduced body weight but also helped prevent weight regain after GLP-1RA discontinuation[5](index=5&type=chunk) - Based on these new preclinical insights, Aardvark is advancing two Phase II trials for ARD-201: the POWER and STRENGTH trials, replacing the previously planned EMPOWER trial[5](index=5&type=chunk) [Updated Milestones](index=2&type=section&id=Updated%20Milestones) The company announced expected timelines for several clinical trials, including ARD-101's HERO Phase III data in **Q3 2026**, ARD-201's POWER Phase II trial initiation in **H2 2025**, STRENGTH Phase II trial in **H1 2026**, and ARD-101's HONOR Phase II trial initiation in **H2 2025** with data in **H2 2026** - Top-line data from the ARD-101 HERO Phase III trial for PWS-related hyperphagia is anticipated in **Q3 2026**[10](index=10&type=chunk) - The ARD-201 POWER Phase II trial, preventing weight regain in patients discontinuing GLP-1RAs, is expected to initiate in **H2 2025**[10](index=10&type=chunk) - The ARD-201 STRENGTH Phase II trial, evaluating weight loss and additive effects in combination with GLP-1RAs, is expected to initiate in **H1 2026**[10](index=10&type=chunk) - The ARD-101 HONOR Phase II trial for acquired hypothalamic obesity-related hyperphagia is expected to initiate in **H2 2025**, with top-line data anticipated in **H2 2026**[10](index=10&type=chunk) [Business & Corporate Updates](index=2&type=section&id=Business%20%26%20Corporate%20Updates) This section covers recent strategic enhancements to the company's leadership team and its participation in key industry conferences [Leadership Team Appointments](index=2&type=section&id=Leadership%20Team%20Appointments) In May 2025, Aardvark strengthened its leadership team through strategic hires, appointing a Chief Scientific Officer, Chief Commercial Officer, Senior Vice President of Regulatory Affairs, and General Counsel - In May 2025, Aardvark strengthened its leadership team across scientific, commercial, regulatory, and legal functions by appointing Dr. Timothy Kieffer as Chief Scientific Officer, Danny Villeneuve as Chief Commercial Officer, Dr. Terrie Kellmeyer as Senior Vice President of Regulatory Affairs, and Christian Zapf as General Counsel[10](index=10&type=chunk) [Conference Presentations](index=2&type=section&id=Conference%20Presentations) In June 2025, Aardvark presented data from the ARD-101 PWS Phase II trial at the 2025 United in Hope conference, with its Chief Medical Officer participating in a discussion about the HERO Phase III trial - In June 2025, Aardvark presented data from the ARD-101 PWS Phase II trial in both poster and oral presentations at the 2025 United in Hope conference[10](index=10&type=chunk) - Aardvark's Chief Medical Officer, Dr. Manasi Jaiman, participated in a clinician panel discussion regarding the details of the company's ongoing HERO Phase III trial[10](index=10&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) This section provides an overview of Aardvark's financial results for the second quarter of 2025, including cash position, operating expenses, and net loss [Select Second Quarter 2025 Financial Highlights](index=2&type=section&id=Select%20Second%20Quarter%202025%20Financial%20Highlights) As of June 30, 2025, Aardvark held **$141.8 million** in cash, cash equivalents, and short-term investments, projected to fund operations into 2027, while significant increases in R&D and G&A expenses led to an expanded net loss of **$14.4 million** Cash Position | Metric | Amount (Million USD) | | :--------------------------------- | :-------------- | | Cash, cash equivalents, and short-term investments (as of June 30, 2025) | 141.8 | | Expected operational support duration | 2027 | Research and Development Expenses (Million USD) | Period | Quarter Ended June 30, 2025 | Quarter Ended June 30, 2024 | Change | | :--- | :------------------ | :------------------ | :----- | | R&D Expenses | 13.1 | 4.0 | +9.1 | General and Administrative Expenses (Million USD) | Period | Quarter Ended June 30, 2025 | Quarter Ended June 30, 2024 | Change | | :--- | :------------------ | :------------------ | :----- | | G&A Expenses | 2.7 | 2.0 | +0.7 | Net Loss (Million USD) | Period | Quarter Ended June 30, 2025 | Quarter Ended June 30, 2024 | Change | | :--- | :------------------ | :------------------ | :----- | | Net Loss | (14.4) | (5.4) | -9.0 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) In Q2 2025, Aardvark experienced substantial increases in both research and development and general and administrative expenses, leading to significantly expanded operating and net losses year-over-year, though net loss per share decreased to **$(0.66)** due to increased weighted average shares outstanding Condensed Consolidated Statements of Operations (Thousands of USD, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :------------------ | :------------------ | :------------------ | :------------------ | | Research and development expenses | 13,145 | 4,029 | 20,900 | 5,236 | | General and administrative expenses | 2,703 | 2,030 | 5,418 | 2,891 | | Total operating expenses | 15,848 | 6,073 | 26,318 | 8,244 | | Operating loss | (15,848) | (6,073) | (26,318) | (8,244) | | Other income (expense), net | 1,481 | 624 | 2,641 | 617 | | Net loss | (14,367) | (5,449) | (23,677) | (7,627) | | Net loss per share, basic and diluted | (0.66) | (1.37) | (1.36) | (1.92) | | Weighted-average shares used in net loss per share calculation | 21,690,275 | 3,967,984 | 17,465,965 | 3,967,658 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Aardvark's total assets increased from **$77.507 million** to **$147.475 million**, primarily due to a significant rise in short-term investments, while total liabilities also increased, and stockholders' equity shifted from a deficit to a positive value Condensed Consolidated Balance Sheets (Thousands of USD) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :--------------------------------- | :----------------------- | :------------- | | **ASSETS** | | | | Cash and cash equivalents | 25,998 | 61,641 | | Short-term investments | 115,822 | 12,022 | | Prepaid expenses and other current assets | 2,948 | 474 | | Total current assets | 144,768 | 74,137 | | Operating lease right-of-use assets | 522 | 735 | | Other assets | 2,185 | 2,635 | | **Total assets** | **147,475** | **77,507** | | **LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ (DEFICIT) EQUITY** | | | | Accounts payable | 5,056 | 2,298 | | Accrued liabilities | 4,837 | 2,291 | | Current operating lease liabilities | 417 | 338 | | Total current liabilities | 10,310 | 4,927 | | Non-current operating lease liabilities | 228 | 441 | | Other long-term liabilities | 12 | 26 | | **Total liabilities** | **10,550** | **5,394** | | Convertible preferred stock | — | 126,756 | | **Stockholders’ (deficit) equity** | | | | Additional paid-in capital | 218,932 | 3,684 | | Accumulated other comprehensive income | (3) | — | | Accumulated deficit | (82,004) | (58,327) | | **Total stockholders’ (deficit) equity** | **136,925** | **(54,643)** | | **Total liabilities, convertible preferred stock and stockholders’ (deficit) equity** | **147,475** | **77,507** | [About Aardvark Therapeutics, Inc.](index=3&type=section&id=About%20Aardvark%20Therapeutics%2C%20Inc.) Aardvark Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing novel small molecule therapies to suppress hunger for the treatment of PWS and metabolic diseases, differentiating hunger from appetite and exploring its therapies in hunger-related indications and in combination with anti-appetite therapies, with lead compound oral ARD-101 in Phase III clinical development for PWS-related hyperphagia and ARD-201 in development to address GLP-1 therapy limitations - Aardvark is a clinical-stage biopharmaceutical company developing novel small molecule therapies designed to suppress hunger for the treatment of PWS and metabolic diseases[11](index=11&type=chunk) - The company differentiates hunger (discomfort caused by not eating) from appetite (desire to seek food) and explores the potential of its therapies in hunger-related indications and in combination with anti-appetite therapies[11](index=11&type=chunk) - Its lead compound, oral ARD-101, is in Phase III clinical development for PWS-related hyperphagia and is also being investigated for hypothalamic obesity[11](index=11&type=chunk) - Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 and a DPP-4 inhibitor, designed to address some limitations of current GLP-1 therapies in treating obesity and related conditions[11](index=11&type=chunk) [Forward-Looking Statements & Contact Information](index=3&type=section&id=Forward-Looking%20Statements%20%26%20Contact%20Information) This section outlines the forward-looking nature of statements within the report and provides contact details for further inquiries [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains "forward-looking statements" regarding future expectations, plans, and prospects, which are based on management's current expectations and are subject to various important factors that could cause actual results to differ materially, with the company undertaking no obligation to update them - Statements in this press release, such as those concerning future operating results, financial position, business strategy, product candidates, clinical trial timelines, and cash flow projections, constitute "forward-looking statements"[12](index=12&type=chunk) - Forward-looking statements are subject to various important factors that could cause actual results to differ materially from expectations, including risks such as clinical trial delays, insufficient capital resources, reliance on third-party manufacturing, and unfavorable clinical trial results[12](index=12&type=chunk) - The company undertakes no obligation to update any forward-looking statements due to new information, future events, or otherwise[12](index=12&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) Investors and media can contact Carolyn Hawley for more information - Contact: Carolyn Hawley, Inizio Evoke Comms, Phone: (619) 849-5382, Email: Carolyn.hawley@inizioevoke.com[13](index=13&type=chunk)

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]

Core Insights - Aardvark Therapeutics announced positive preclinical data for ARD-201, indicating its potential for treating metabolic obesity and related conditions, particularly in weight maintenance after GLP-1RA therapy withdrawal [1][5][7] Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at treating metabolic diseases and hunger-related conditions [9] - The lead compound, ARD-101, is in Phase 3 clinical development for hyperphagia associated with Prader-Willi Syndrome, while ARD-201 is a fixed-dose combination of ARD-101 and a DPP-4 inhibitor [9] Preclinical Study Findings - In a validated diet-induced obesity mouse model, ARD-201 demonstrated a significant weight loss of approximately 19% after 30 days of treatment [2][5] - ARD-201 showed improved weight maintenance compared to negative controls and similar results to high-dose tirzepatide, a benchmark GLP-1RA therapy [2][5] - The combination of ARD-201 with low-dose tirzepatide resulted in continued weight loss compared to high-dose tirzepatide alone [5] Future Clinical Trials - Aardvark plans to initiate two Phase 2 clinical trials: the POWER trial focusing on weight rebound prevention after GLP-1RA therapy discontinuation, and the STRENGTH trial assessing weight loss as a monotherapy and in combination with GLP-1RA [6][10] - The POWER trial is expected to start in the second half of 2025, while the STRENGTH trial is planned for the first half of 2026 [10] Mechanism of Action - ARD-201 combines a DPP-4 inhibitor with ARD-101, targeting taste receptors in the gut to enhance satiety and reduce hunger by stimulating the release of signaling molecules like GLP-1 [7][9]

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]