SAN DIEGO, Nov. 25, 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, announced that it will present at the following conferences during December: Piper Sandler 37th Annual Healthcare Conference in New YorkPresentation: Wednesday, December 3 at 8:00 a.m. ETEvercore ISI 8th Annual Healthcare Conferenc ...

Aardvark Therapeutics Conference Summary Company Overview - Aardvark Therapeutics is a publicly traded company based in San Diego, founded in 2017, focusing on gut-brain signaling drugs to reduce hunger, with a lead program targeting Prader-Willi syndrome currently in phase three, expecting readout in Q3 2026 [5][39] Core Points and Arguments Obesity and Prader-Willi Syndrome - Aardvark's approach involves oral small molecule drugs that target beta taste receptors in the gut, which are linked to appetite regulation [6][8] - The lead drug, ARD-101, is designed to suppress appetite by triggering hormone release in the intestine, with 99% of the drug remaining in the gut [9][12] - Aardvark's mechanism is considered orthogonal to GLP-1 receptor agonists, which primarily reduce appetite but can lead to nausea and weight rebound upon discontinuation [12][13] Safety Profile - In phase one and two trials, over 70 patients were treated with no significant adverse events beyond grade two, indicating a favorable safety profile [14] Obesity Program and ARD-201 - ARD-201 combines ARD-101 with a DPP-4 inhibitor to prolong the activity of gut hormones, showing promising preclinical results with a 19% body weight loss in 30 days, comparable to high-dose tirzepatide [19][20] - The program aims to provide an "off-ramp" for patients discontinuing GLP-1 receptor agonists, addressing the issue of rapid weight regain [20][28] Clinical Trials - The POWER trial will focus on patients who have lost weight on GLP-1s and aim to maintain that weight loss with ARD-201, expecting readout in the second half of 2026 [28][32] - The STRENGTH trial will evaluate ARD-201 against ARD-201 plus GLP-1, with initiation expected in the first half of 2026 [29][30] Phase Two Data for Prader-Willi Syndrome - Phase two results showed significant reductions in hyperphagia scores, with patients demonstrating behaviors such as leaving food uneaten, indicating potential efficacy [24][25] - The HERO trial for Prader-Willi syndrome is ongoing, with a target enrollment of 90 patients and expected top-line results in Q3 2026 [39][47] Future Directions - Aardvark is exploring additional programs, including a drug derived from a soybean compound that may offer weight loss benefits through a different mechanism, currently seeking partnership opportunities [35][36] Other Important Content - The company plans to expand the age range for the HERO trial to include younger patients, potentially down to age 4, to better represent the target population [44] - Aardvark anticipates a minimum reduction of 6 points in the HQCT score for the HERO trial to demonstrate efficacy, with a robust design to ensure statistical significance [46][47]

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, with topline data expected in Q3 2026[99]. - Enrollment for the HERO clinical trial began in Q2 2025, with protocol amendments made to broaden eligibility, including lowering the minimum age from 13 to 10 years[99]. - The company plans to replace the previously intended EMPOWER trial with two new Phase 2 trials for ARD-201, focusing on weight regain prevention and weight loss[101][103]. - The POWER trial is expected to initiate in the second half of 2025, with interim data anticipated in the second half of 2026, targeting weight regain after GLP-1 receptor agonist treatment[101]. - The STRENGTH trial, also a Phase 2 study, is planned for the first half of 2026, exploring the additive effects of ARD-201 in combination with GLP-1RA therapy[103]. - The company has delayed plans for a Phase 2 trial of ARD-101 for hypothalamic obesity to focus resources on ARD-201[100]. - The ARD-101 program is currently in Phase 3, while ARD-201 is in Phase 2, with both targeting obesity-related conditions[105]. - The HERO Open Label Extension trial commenced in Q3 2025, allowing patients from the HERO trial to continue receiving treatment[99]. - The company is focused on developing small-molecule therapeutics targeting Bitter Taste Receptors (TAS2Rs) to address hunger-associated conditions[98]. - ARD-201 induced significant weight loss of -18.8% ± 2.1% in DIO mice after 30 days of treatment while on a high-fat diet[107]. - Glucose homeostasis improved in the ARD-201 group on Day 14 compared to the negative control, as indicated by the area under the curve (AUC) from an Intraperitoneal Glucose Tolerance Test (IPGTT)[112]. - At termination of the preclinical study, ARD-201 monotherapy and the combination with low-dose tirzepatide showed significant reductions in fat mass compared to the vehicle group[121]. Financial Performance and Funding - As of September 30, 2025, the company had an accumulated deficit of $98.3 million and net losses of $16.3 million and $40.0 million for the three and nine months ended September 30, 2025, respectively[125]. - The company raised a total of $129.1 million in gross proceeds from the sale of convertible preferred stock and completed its IPO in February 2025, receiving net proceeds of approximately $87.5 million[127]. - The company does not expect to generate any revenue from product sales until regulatory approval for ARD-101 or other product candidates is obtained, which may take several years[128]. - The company plans to continue developing ARD-101 and other product candidates, conduct ongoing clinical trials, and expand its intellectual property portfolio[129]. - The company has incurred significant operating expenses, primarily in research and development, which are expected to increase substantially in the foreseeable future[135]. - Research and development (R&D) expenses increased to $13.7 million for the three months ended September 30, 2025, compared to $4.1 million for the same period in 2024, representing a $9.7 million increase[152]. - General and administrative (G&A) expenses rose to $4.0 million for the three months ended September 30, 2025, up from $1.0 million in 2024, marking a $2.9 million increase[154]. - The net loss for the three months ended September 30, 2025, was $16.3 million, compared to a net loss of $4.2 million for the same period in 2024, reflecting a $12.1 million increase in losses[152]. - For the nine months ended September 30, 2025, total R&D expenses were $34.6 million, up from $9.3 million in 2024, indicating a $25.3 million increase[158]. - G&A expenses for the nine months ended September 30, 2025, were $9.4 million, compared to $3.9 million in 2024, resulting in a $5.5 million increase[159]. - The company reported a net loss of $40.0 million for the nine months ended September 30, 2025, compared to a net loss of $11.8 million for the same period in 2024, an increase of $28.2 million[156]. - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $126.4 million, which is expected to fund operations into 2027[163]. - 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 of common stock at an IPO price of $16.00 per share[162]. - The company anticipates substantial increases in G&A expenses as it expands its headcount to support ongoing R&D and potential commercialization activities[148]. - The accumulated deficit as of September 30, 2025, was $98.3 million, with expectations of continued losses for the foreseeable future[165]. - Net cash used in operating activities increased to $37.4 million for the nine months ended September 30, 2025, compared to $10.4 million for the same period in 2024, primarily due to a reported net loss of $40.0 million[170]. - Net cash used in investing activities was $74.0 million for the nine months ended September 30, 2025, mainly from the purchase of short-term investments, while it was only $0.1 million in 2024[171]. - Net cash provided by financing activities was $89.0 million for the nine months ended September 30, 2025, primarily from the IPO proceeds of $91.1 million, net of costs[172]. - The company reported a net loss of $40.0 million for the nine months ended September 30, 2025, compared to a net loss of $11.8 million for the same period in 2024[170]. - The increase in cash used in operations in 2025 was primarily attributable to increased research and development activities[170]. Operational and Economic Factors - The company relies on third parties for the manufacture of ARD-101 and other product candidates, aiming to maintain an efficient infrastructure[131]. - Macroeconomic trends, including inflation and geopolitical conflicts, may negatively impact the company's business and financial position[133]. - The company has not experienced material changes in its contractual obligations and other commitments as of March 31, 2025[173]. - The company does not believe that inflation has had a material effect on its results of operations during the periods presented[179]. - The company has not had a formal hedging program for foreign currency, and the impact of foreign currency costs has been negligible[178]. - The company is exposed to interest rate risk but does not expect a hypothetical 100 basis point change in interest rates to materially impact its financial statements[177]. - The company is focused on enhancing operational systems and hiring additional personnel to meet public company obligations[170].

Financial Performance - Aardvark Therapeutics reported a net loss of $16.3 million for Q3 2025, compared to a net loss of $4.2 million in Q3 2024, reflecting a significant increase in operating expenses[5]. - Total operating expenses for Q3 2025 were $17.7 million, compared to $5.1 million in Q3 2024, indicating a substantial increase in operational costs[9]. Research and Development - Research and development expenses rose to $13.7 million in Q3 2025 from $4.1 million in Q3 2024, primarily due to increased development costs related to ARD-101[5]. - Aardvark plans to advance ARD-201 into two Phase 2 trials, POWER and STRENGTH, to evaluate its effectiveness in weight management and glucose control[2]. - Preclinical data indicated that ARD-201 achieved approximately 19% weight reduction after 30 days and around 30% weight loss when combined with low-dose tirzepatide[5]. - The Phase 3 HERO trial for ARD-101 has expanded eligibility to pediatric patients aged 10 and above, increasing the potential target market for Prader-Willi Syndrome treatment[3]. - Topline data from the Phase 3 HERO trial is expected in Q3 2026, while preliminary data from the Phase 2 POWER trial is anticipated in the second half of 2026[5]. Financial Position - As of September 30, 2025, Aardvark had cash, cash equivalents, and short-term investments totaling $126.4 million, sufficient to fund operations into 2027[5]. - Aardvark's total assets as of September 30, 2025, were $133.2 million, up from $77.5 million at the end of 2024, reflecting growth in current assets[11]. General and Administrative Expenses - General and administrative expenses increased to $4.0 million in Q3 2025 from $1.0 million in Q3 2024, attributed to higher personnel-related costs and professional fees[5].

Core Insights - Aardvark Therapeutics has aligned with the FDA to lower the minimum age for pediatric patients in the Phase 3 HERO trial of ARD-101 from 13 to 10 years, expanding the eligible population for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS) [1][3] - New preclinical data presented at ObesityWeek 2025 highlights the potential of ARD-201 in enhancing glucose control and preserving lean body mass, addressing significant challenges in obesity treatment [2][4] - Aardvark reported $126.4 million in cash and short-term investments as of September 30, 2025, which is projected to support operations into 2027 [1][9] Clinical Program Updates - The HERO trial for ARD-101 has commenced enrollment with the new age eligibility of 10 years, broadening the target market for PWS [3] - Aardvark plans to advance ARD-201 into two Phase 2 trials, POWER and STRENGTH, to further evaluate its efficacy in metabolic obesity [2][4] Financial Highlights - Research and development expenses increased to $13.7 million for the quarter ended September 30, 2025, compared to $4.1 million in the same quarter of 2024, primarily due to higher development costs for ARD-101 [9] - General and administrative expenses rose to $4.0 million for the quarter ended September 30, 2025, from $1.0 million in the same quarter of 2024, reflecting increased personnel and operational costs [9] - The net loss for the quarter ending September 30, 2025, was $16.3 million, compared to $4.2 million for the same period in 2024, driven by increased operating expenses [9][12]

Aardvark Therapeutics Conference Call Summary Company Overview - **Company**: Aardvark Therapeutics (NasdaqGS:AARD) - **Lead Program**: ARD-101, an oral small molecule drug targeting gut receptors to manage hunger and eating behavior, particularly in Prader-Willi syndrome, a pediatric rare disease characterized by hyperphagia [2][6][18]. Key Points on ARD-101 - **Mechanism of Action**: ARD-101 is designed to convey gut-brain signaling to reduce hunger and improve metabolic benefits. It specifically targets gut receptors to stimulate gut hormones that regulate hunger and appetite [2][6][7]. - **Clinical Trials**: - Phase 2 data showed promising results with 18 subjects, leading to a Phase 3 HERO trial with expected top-line results in Q3 2026 [2][20]. - The Phase 2 trial reported a significant reduction in hunger, with a -8 reduction in HQCT scores over a short period [20][22]. - The Phase 3 trial will include a higher cutoff for HQCT scores, aiming for a more robust benefit [22][30]. Comparison with Other Treatments - **GLP-1 Class Drugs**: Existing medications like GLP-1s primarily address appetite but not hunger, which is crucial for Prader-Willi patients. ARD-101 uniquely targets hunger-driven mechanisms [4][6][9]. - **Market Opportunity**: Approximately 50% of Prader-Willi patients may not respond adequately to Vycat, indicating a significant market for ARD-101 [60][61]. Secondary Benefits and Biomarkers - **Additional Assessments**: The trial will also evaluate anxiety levels, inflammation markers, and body composition changes, with a noted 1.5% reduction in body fat and 2% increase in lean body mass during Phase 2 [26][28]. - **Glucose Homeostasis**: ARD-101 is expected to improve glucose levels, which is critical for patients prone to hyperglycemia [28]. Obesity Program Overview - **Combination Therapy**: ARD-201 combines ARD-101 with sitagliptin (a DPP-4 inhibitor) to enhance the duration of hormone activity, showing promising preclinical results with significant weight loss [69][72]. - **Clinical Trials**: The POWER trial will assess the efficacy of ARD-201 in patients transitioning from GLP-1 treatments, with data expected in the second half of 2026 [81][85]. Strategic Considerations - **Partnership Opportunities**: Aardvark Therapeutics is exploring partnerships for the obesity asset while retaining control over the Prader-Willi program [86]. Conclusion Aardvark Therapeutics is positioned to address significant unmet needs in the treatment of Prader-Willi syndrome and obesity through innovative mechanisms targeting hunger and metabolic regulation. The upcoming clinical data and strategic partnerships will be critical in shaping the company's future in these therapeutic areas.

Core Insights - Aardvark Therapeutics, Inc. has granted a stock option to a new employee as part of its 2025 Inducement Equity Incentive Plan, which includes 4,881 shares of common stock [1][2] Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at activating innate homeostatic pathways for metabolic diseases [1][4] - The company is developing treatments specifically for Prader-Willi Syndrome (PWS) and other metabolic diseases, with its lead compound, ARD-101, currently in Phase 3 clinical development for hyperphagia associated with PWS [4] - Aardvark is also working on ARD-201, a fixed-dose combination therapy, and conducting trials to address limitations of existing GLP-1 therapies for obesity and related conditions [4] Stock Option Details - The stock option granted has an exercise price of $10.44, which is the closing price of Aardvark's common stock on the grant date [3] - The option will vest over four years, with 25% vesting on the one-year anniversary of employment and the remainder vesting monthly thereafter, contingent on continued employment [3]

Aardvark Therapeutics Investor Webinar Summary Company Overview - **Company**: Aardvark Therapeutics (NasdaqGS:AARD) - **Focus**: Development of therapies for obesity and related metabolic disorders, particularly through innovative drug combinations and mechanisms targeting hunger and appetite regulation Key Points and Arguments Clinical Programs - **ARD201**: A fixed-dose combination of TAS2R agonist (ARD101) and DPP-4 inhibitor (acetagliptin) aimed at treating metabolic obesity, showing promising preclinical results [3][7] - **WE868**: A newly in-licensed program exploring a novel mechanism for obesity, currently in preclinical studies [3][4] - **ARD101**: Currently in the HERO phase 3 study for hyperphagia associated with Prader-Willi syndrome, with expected pivotal data readout in Q3 2026 [5][8] Data Highlights - **ARD201** demonstrated a 19% weight loss in a diet-induced obesity mouse model over 30 days, comparable to high-dose tirzepatide (20.5% weight loss) [10] - **Weight Maintenance**: ARD201 showed preservation of weight loss after discontinuation of GLP-1 therapies, achieving approximately 30% weight loss when combined with a microdose of tirzepatide [11] - **Body Composition**: ARD201 preserved lean mass while reducing fat mass, addressing concerns of lean mass loss associated with GLP-1 therapies [12] - **Glucose Homeostasis**: Improvements in glucose tolerance were observed in mice treated with ARD201, indicating potential benefits for patients with obesity-related diabetes [13] Mechanism of Action - **Gut-Brain Signaling**: ARD101 targets gut peptide hormone release to regulate hunger, contrasting with GLP-1 therapies that primarily focus on appetite signaling [6] - **WE868 Mechanism**: Modulates cellular energy use without mitochondrial uncoupling, leading to increased energy expenditure and weight loss [16] Industry Context - **Obesity Treatment Landscape**: The prevalence of obesity is rising, necessitating effective treatments. Aardvark's approach aims to mimic the effects of bariatric surgery through pharmacotherapy [35][38] - **Emerging Trends**: The development of combination therapies and multi-agonist approaches is seen as a future direction in obesity treatment, with potential for improved efficacy and reduced side effects [44][48] Challenges and Unmet Needs - **Side Effects**: Current GLP-1 therapies are associated with nausea and lean mass loss, highlighting the need for better-tolerated options [47][50] - **Insurance Coverage**: Changes in insurance coverage for GLP-1 therapies in Massachusetts may limit access for patients, emphasizing the need for alternative treatments [56] Additional Insights - **Gut-Brain Axis Research**: Ongoing studies into the gut-brain axis and its role in regulating appetite and glucose homeostasis are critical for understanding obesity mechanisms [21][27] - **Nutrient Sensing**: The interplay between nutrient sensing and gut hormones is crucial for developing effective obesity treatments [33][34] Conclusion Aardvark Therapeutics is positioned to make significant contributions to the obesity treatment landscape through innovative drug development and a focus on understanding the underlying mechanisms of hunger and appetite regulation. The upcoming clinical milestones and ongoing research into new compounds like WE868 could provide valuable insights and therapeutic options for patients struggling with obesity and related metabolic disorders.

Core Insights - Aardvark Therapeutics is advancing ARD-201, a novel therapy aimed at improving glucose control and preserving lean mass, addressing challenges in obesity treatment [1][3] - The company plans to initiate two Phase 2 trials for ARD-201, named POWER and STRENGTH, to evaluate its efficacy in preventing weight regain and promoting weight loss [2][13] ARD-201 Obesity Program - ARD-201 is a fixed-dose combination of TAS2R agonist ARD-101 and DPP-4 inhibitor sitagliptin, designed to enhance appetite suppression and metabolic effects [3][10] - Preclinical studies indicate that ARD-201 can reduce fat mass while preserving lean mass, achieving glucose control comparable to high-dose tirzepatide [5][10] - Previous preclinical data showed ARD-201 resulted in approximately 19% weight loss after 30 days, similar to high-dose tirzepatide, and around 30% weight loss when combined with low-dose tirzepatide [5][10] Clinical Development - ARD-201 is set to enter the Phase 2 POWER trial by the end of 2025, focusing on preventing weight regain in subjects who have previously lost significant weight [13] - The STRENGTH trial is planned for the first half of 2026, assessing the potential for placebo-adjusted weight loss and the additive effects of ARD-201 with GLP-1RA therapy [13] Investor Engagement - Aardvark will host an investor webinar on November 5, 2025, to discuss the data presented at ObesityWeek and provide insights into ARD-101, ARD-201, and WE-868 [6][7]

Core Insights - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at activating innate homeostatic pathways for metabolic diseases [1][2] - The company will present at two upcoming conferences in November, with live webcasts available on its website [1][4] Company Overview - Aardvark is developing therapeutics designed to suppress hunger, particularly for the treatment of Prader-Willi Syndrome (PWS) and other metabolic diseases [2] - The lead compound, ARD-101, is in Phase 3 clinical development for hyperphagia associated with PWS, characterized by insatiable hunger [2] - Aardvark is also working on ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, to address limitations of current GLP-1 therapies for obesity [2]