Aardvark Therapeutics Inc(AARD) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Report Overview 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 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] - 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] - 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] Key Highlights 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] - 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] 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 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) 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] - This expansion is supported by the PWS community and historical data indicating that younger patients are more likely to benefit from earlier intervention[4] ARD-201 for Obesity 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] - 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] Updated Milestones 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] - The ARD-201 POWER Phase II trial, preventing weight regain in patients discontinuing GLP-1RAs, is expected to initiate in H2 2025[10] - 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] - 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] Business & Corporate Updates This section covers recent strategic enhancements to the company's leadership team and its participation in key industry conferences Leadership Team Appointments 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] Conference Presentations 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] - 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] Financial Performance 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 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 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 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. 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] - 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] - 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] - 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] Forward-Looking Statements & Contact Information This section outlines the forward-looking nature of statements within the report and provides contact details for further inquiries Forward-Looking Statements 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] - 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] - The company undertakes no obligation to update any forward-looking statements due to new information, future events, or otherwise[12] Contact Information 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]