Within the family program agenda, Aardvark's Chief Medical Officer, Manasi Jaiman, M.D., will join a panel of clinicians to discuss the details of the company's ongoing Phase 3 HERO study. Additional members of the company's medical and advocacy team invite the medical community and families attending to engage with attending team members at the company's booth to learn more about ARD-101, the HERO study and the company's commitment to the PWS community. SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- Aardvark ...

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 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].