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]

Aardvark Therapeutics (AARD) Conference Call Summary Company Overview - Aardvark Therapeutics is a publicly traded company based in San Diego, California, focusing on developing oral small molecule drugs targeting bitter taste receptors to influence gut-brain signaling pathways related to hunger and appetite [2][3] Clinical Programs - The most advanced program is for Prader Willi syndrome, currently in a pivotal phase three trial with expected readout in early 2026 [4] - Plans to initiate a phase two program for hypothalamic obesity and advance another formulation, ARD 201, for general obesity [4][18] Drug Mechanism and Differentiation - Aardvark's drug targets hunger rather than appetite, differentiating it from GLP-1 drugs, which primarily suppress appetite [5][7] - The drug works through gut-brain pathways, reducing ghrelin levels, which is contrary to the effect of GLP-1 treatments that can increase ghrelin [8][20] - The company believes that CCK deficiency contributes to symptoms of Prader Willi syndrome and general obesity, which their drug aims to address [9] Clinical Data and Efficacy - In the phase two trial for Prader Willi syndrome, patients showed an average reduction of 30% in hyperphagia scores (HQCT) over a 28-day dosing period [12][14] - A subgroup of patients with similar features to those expected in the phase three trial experienced a 48% reduction in HQCT, indicating a high probability of success for the upcoming trial [15] - The drug has shown a favorable safety profile, with no adverse events exceeding grade two reported in over 70 patients dosed [11] Future Trials and Endpoints - The phase three trial will include a randomized, placebo-controlled design with primary endpoints focused on HQCT scores at week twelve [15][16] - Secondary endpoints will assess clinical global impression, body composition, inflammatory biomarkers, and ghrelin levels [16] Additional Programs - The hypothalamic obesity program is set to leverage similarities with Prader Willi syndrome, targeting patients with overactive hunger due to prior interventions [17] - The ARD 201 program aims to combine ARD 101 with a TPD4 inhibitor, enhancing its efficacy for general obesity while being cautious of its use in Prader Willi syndrome due to potential risks [18] Market Potential - There are approximately 10,000 to 25,000 patients in the U.S. with Prader Willi syndrome, with a global occurrence rate of 1 in 15,000 live births, suggesting a significant market opportunity [10] - The company aims to demonstrate additive benefits of their drug on top of existing GLP-1 therapies, potentially appealing to a broader patient population [20][22] Summary - Aardvark Therapeutics is strategically positioned with a unique approach to treating hunger-related conditions, backed by promising clinical data and a robust pipeline of programs targeting rare and general obesity [22]

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].

Financial Performance - Aardvark Therapeutics raised $97.9 million in gross proceeds from its IPO, with net proceeds of approximately $87.5 million[3]. - The net loss for Q1 2025 was $9.3 million, compared to a net loss of $2.2 million in Q1 2024[7]. - Total operating expenses for Q1 2025 were $10.5 million, significantly higher than $2.2 million in Q1 2024[11]. - The weighted-average shares used in the net loss per share calculation for Q1 2025 were approximately 13.2 million[11]. Cash and Investments - As of March 31, 2025, Aardvark had cash, cash equivalents, and short-term investments totaling $151.3 million, sufficient to fund operations into 2027[6]. - Total assets as of March 31, 2025, were $157.0 million, up from $77.5 million at the end of 2024[13]. Research and Development - Research and development expenses increased to $7.8 million for Q1 2025, up from $1.2 million in Q1 2024, reflecting a $6.6 million increase[6]. - Aardvark's lead candidate, ARD-101, is in Phase 3 clinical development for treating hyperphagia associated with Prader-Willi Syndrome, with data readout expected in early 2026[5]. - Aardvark is also developing ARD-201, a fixed-dose combination aimed at addressing limitations of current GLP-1 therapies for obesity[8]. General and Administrative Expenses - General and administrative expenses rose to $2.7 million in Q1 2025, compared to $0.9 million in Q1 2024, marking a $1.9 million increase[6].

Core Viewpoint - Aardvark Therapeutics is focused on developing innovative small-molecule therapeutics aimed at activating innate homeostatic pathways to treat metabolic diseases, with a particular emphasis on addressing hunger signaling in rare metabolic diseases and obesity [2][5]. Business Highlights - Aardvark completed its initial public offering (IPO) in February 2025, raising $97.9 million in gross proceeds, resulting in approximately $87.5 million in net proceeds after expenses [3]. - The company's stock began trading under the symbol "AARD" on February 13, 2025 [3]. Financial Highlights - As of March 31, 2025, Aardvark reported cash, cash equivalents, and short-term investments totaling $151.3 million, which is expected to support operations into 2027 [6][7]. - Research and development expenses for the first quarter of 2025 were $7.8 million, a significant increase from $1.2 million in the same quarter of 2024, primarily due to higher development costs related to ARD-101 [7]. - General and administrative expenses rose to $2.7 million in the first quarter of 2025 from $0.9 million in the same quarter of 2024, attributed to increased professional fees and costs associated with being a public company [7]. - The net loss for the first quarter of 2025 was $9.3 million, compared to a net loss of $2.2 million in the first quarter of 2024 [7][10]. Clinical Development - Aardvark's lead candidate, ARD-101, is in Phase 3 clinical development for treating hyperphagia associated with Prader-Willi Syndrome (PWS), with data readout expected in early 2026 [6][2]. - 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 [5].

Core Viewpoint - Aardvark Therapeutics, Inc. is actively engaging in presenting its clinical developments and strategies at various conferences in May 2025, highlighting its focus on novel therapeutics for metabolic diseases [1][4]. Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company that develops small-molecule therapeutics aimed at suppressing hunger, particularly for conditions like Prader-Willi Syndrome (PWS) and other metabolic diseases [2]. - The lead compound, ARD-101, is currently in Phase 3 clinical development for treating hyperphagia associated with PWS and is also being studied for hypothalamic obesity [2]. - Aardvark is developing ARD-201, a combination of ARD-101 and a DPP-4 inhibitor, to address limitations of existing GLP-1 therapies for obesity and related conditions [2]. Upcoming Presentations - Aardvark will present at the following conferences: - Bank of America Global Healthcare Conference on May 15, 2025, at 12:35 p.m. ET [4]. - H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 3:30 p.m. ET [4]. - RBC Capital Markets Global Healthcare Conference on May 21, 2025, at 2:35 p.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-presentation [1].

Clinical Trials and Product Development - The company has initiated a Phase 3 clinical trial for its lead product candidate, ARD-101, targeting hyperphagia associated with Prader-Willi Syndrome (PWS), with topline data expected in early 2026[16]. - In a completed Phase 2 clinical trial for ARD-101 in subjects with PWS, 12 subjects showed an average decline of approximately 8 points in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score after 28 days[18]. - The company plans to conduct a Phase 2 clinical trial for hyperphagia associated with hypothalamic obesity (HO), referred to as the HONOR trial, expected to initiate in the second half of 2025[19]. - ARD-201, a fixed-dose combination of ARD-101 and a DPP-4 inhibitor, is being developed to address obesity and obesity-related conditions, with a Phase 2 EMPOWER trial planned for the second half of 2025[20]. - The Phase 2 clinical trial of ARD-101 demonstrated well-tolerated results with limited systemic absorption, reducing potential systemic toxicity[18]. - The Phase 3 HERO trial for ARD-101 in subjects with hyperphagia associated with PWS was initiated in December 2024, with results expected in early 2026[61]. - The Phase 3 HERO trial for ARD-101 is designed to treat subjects with PWS-associated hyperphagia over 12 weeks, with topline data expected in early 2026[101]. - The company plans to conduct the Phase 3 trial in multiple countries, including the United States, the United Kingdom, and South Korea[101]. - The company plans to initiate the Phase 2 clinical trial for ARD-101 in hyperphagia associated with hypothalamic obesity (HO) in the second half of 2025, with topline data expected in the first half of 2026[111]. - In Phase 2a clinical trials, ARD-101 demonstrated a 2.51-fold greater reduction in hunger rating compared to placebo, with a statistically significant p-value of 0.015[136]. - The company has completed Phase 2a clinical trials of ARD-101, which showed no dose-limiting safety issues or serious adverse events (SAEs)[113]. - The second part of the Phase 2 trial involved dose escalation from 400 mg to 800 mg BID, with all patients experiencing benefits and mild adverse events[90]. Financials and Funding - The company raised $129.1 million prior to its IPO in February 2025, including $85.0 million from a Series C financing in May 2024, and net proceeds from the IPO were approximately $87.5 million[25]. - The estimated cost of obesity-related healthcare in the U.S. was $261 billion in 2016, emphasizing the financial burden of obesity on the healthcare system[116]. - The global market for branded anti-obesity drugs is projected to reach over $100 billion by 2030, driven by an estimated increase in global obesity prevalence to over 50% by 2035[116]. Regulatory and Compliance - The company must submit annual progress reports and safety reports to the FDA, detailing any serious adverse reactions or significant risks identified during trials[177]. - The regulatory process for drug candidates requires substantial time and financial resources, with potential delays due to non-compliance leading to administrative or judicial sanctions[170]. - The FDA's review process for New Drug Applications (NDAs) aims for a standard review within 10 months and priority review within 6 months, depending on the product's significance[183]. - The FDA requires satisfactory completion of pre-approval inspections of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP)[173]. - The company is subject to numerous regulatory authorities in the U.S., including the FDA and CMS, impacting manufacturing, sales, and marketing activities[200]. - Non-compliance with regulatory requirements can lead to severe consequences, including criminal prosecution, fines, and product recalls[202]. - The FDA allows for 505(b)(2) NDAs, enabling applicants to use existing studies not conducted by them, which can expedite the approval process[204]. - The FDA's fast track designation program aims to expedite the review of drugs intended for serious conditions, with a determination made within 60 days of the request[191]. - Priority review can shorten the review timeframe to six months for products that significantly improve safety and effectiveness compared to existing therapies[192]. - Accelerated approval may be granted for products that show meaningful advantages over existing therapies, but requires post-approval confirmatory studies[193]. - Post-approval, manufacturers must comply with ongoing FDA regulations, including monitoring adverse experiences and maintaining cGMP compliance[198]. Product Characteristics and Market Need - ARD-101 is an oral gut-restricted small-molecule that is approximately 99% restricted to the gut with minimal systemic exposure, leading to local elevation of gut peptide hormones like CCK and GLP-1[33]. - The hypothalamic obesity condition affects approximately 5,000-10,000 people in the United States, highlighting the unmet need for effective treatments[19]. - The incidence of Prader-Willi Syndrome (PWS) is approximately 1 in 15,000 births globally, with an estimated 10,000 to 20,000 patients in the U.S.[51]. - ARD-101 aims to address the limitations of current GLP-1 therapies by stimulating local secretion of CCK to reduce hunger without significant side effects[42]. - ARD-101 has shown potential in preclinical studies to decrease food intake and body weight without treatment tachyphylaxis, indicating sustained efficacy[62]. - The treatment with ARD-101 led to a mean placebo-adjusted weight loss of approximately -1% at 28 days without chronic nausea, a common issue with GLP-1 receptor agonists[136]. - The company aims to leverage its expertise in TAS2R targeting to expand its pipeline across metabolic, inflammatory, and other adjacent indications[26]. Competition and Market Strategy - The company faces competition from major pharmaceutical companies and biotechnology firms in the obesity treatment market, including Eli Lilly and Novo Nordisk[154]. - The commercial strategy for product candidates is still under evaluation, with potential use of strategic partners or establishing a commercial sales force[159]. - The company plans to selectively evaluate strategic collaborations to enhance the development and commercialization of its product candidates[26]. Intellectual Property - The patent portfolio includes 22 distinct patent application families, with 17 issued U.S. patents and 72 pending applications as of March 12, 2025[161]. - ARD-101 has received orphan drug designation for the treatment of Prader-Willi Syndrome (PWS), which could provide seven years of marketing exclusivity upon approval[162].

Financial Performance - Aardvark Therapeutics reported a net loss of $20.6 million for the year ended December 31, 2024, compared to a net loss of $7.2 million in 2023, representing an increase of 186%[10] - Research and development expenses increased to $17.4 million in 2024 from $4.5 million in 2023, marking a rise of 184%[10] - General and administrative expenses rose to $5.3 million in 2024, up from $2.2 million in 2023, reflecting an increase of 141%[10] - Cash, cash equivalents, and short-term investments totaled $73.7 million as of December 31, 2024, excluding IPO proceeds[10] - As of December 31, 2024, total assets were reported at $77.5 million, a significant increase from $10.5 million in 2023[15] Clinical Trials and Development - The lead candidate ARD-101 showed a meaningful reduction in hyperphagia of up to 16 points in a Phase 2 trial for Prader-Willi Syndrome, with an average reduction of approximately 8 points among compliant subjects[5] - The ongoing Phase 3 HERO trial for ARD-101 is expected to generate topline data in early 2026[6] - Aardvark plans to initiate the Phase 2 HONOR trial for ARD-101 in the second half of 2025, targeting hyperphagia associated with acquired hypothalamic obesity[10] - The company is also set to begin the Phase 2 EMPOWER trial for ARD-201 in the second half of 2025, focusing on obesity and obesity-related conditions[10] IPO and Funding - Aardvark completed its IPO in February 2025, raising $97.9 million in gross proceeds to support ongoing and future pipeline development[6]