The most talked about and market moving research calls around Wall Street are now in one place. Here are today's research calls that investors need to know, as compiled by The Fly.Top Upgrades: More bullish on the name, CFRA upgraded Pool Corp. (POOL) to Buy from Hold with a $304 price target.Piper Sandler upgraded SEI Investments (SEIC) to Overweight from Neutral with a price target of $102, up from $93, as part of a Q4 preview for the asset management group. The firm believes SEI will be a "clear benefic ...

Aardvark Therapeutics, Inc. (NASDAQ:AARD) is a clinical-stage biopharmaceutical company developing small-molecule therapeutics designed to suppress hunger for Prader-Willi Syndrome (PWS) and metabolic diseases.Lead compound, oral ARD-101, is in Phase 3 clinical development for hyperphagia associated with PWS, a rare disease characterized by insatiable hunger.On Wednesday, Aardvark Therapeutics dosed the first patient in Australia in its Phase 3 HERO clinical trial assessing ARD-101.Additionally, regulatory ...

Core Insights - Aardvark Therapeutics is progressing with its Phase 3 HERO trial for ARD-101, targeting hyperphagia in Prader-Willi syndrome (PWS), with topline data expected in Q3 2026 [1][4][6] Group 1: Clinical Trial Progress - The first patient has been dosed in Australia, and regulatory clearance for enrollment has been received in Canada and the UK [1][2] - Strong enrollment is reported in the US, with all patients from the completed 12-week trial participating in the Open Label Extension trial, indicating high patient engagement [2][3] - Aardvark anticipates that it will not need to activate previously planned sites in the EU to meet enrollment goals for the HERO trial [2] Group 2: Trial Details - The HERO trial is a Phase 3 randomized, double-blind, placebo-controlled study enrolling 90 patients across multiple countries [4] - The primary endpoint is the change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12, with secondary measures including caregiver and clinical global impressions of severity [4] Group 3: Product Information - ARD-101 is a gut-restricted small molecule agonist that stimulates the release of gut-peptide hormones to mediate hunger, showing potential to reduce hunger when used alone or with GLP-1 therapies [5][6] - The FDA has granted ARD-101 Orphan Drug Designation and Rare Pediatric Disease Designation for PWS [5] Group 4: Company Overview - Aardvark Therapeutics focuses on developing small-molecule therapeutics to suppress hunger for metabolic diseases, with ARD-101 as its lead compound in clinical development for hyperphagia associated with PWS [7][8]

Aardvark Therapeutics (NasdaqGS:AARD) FY Conference December 04, 2025 11:15 AM ET Company ParticipantsTim Kieffer - Chief Scientific OfficerTien Lee - CEOModeratorOkay, excellent. Well, last but not least, we're going to talk obesity and much more beyond that, but I'll turn it over to you, Tien, to kick things off.Tien LeeGreat. Hi, yeah, I'm glad to be here. I'm Tien from Aardvark Therapeutics, and the CEO of—was that Fireside or?ModeratorI think just folks are still learning some more about the company. S ...

Aardvark Therapeutics FY Conference Summary Company Overview - **Company**: Aardvark Therapeutics (NasdaqGS:AARD) - **Founded**: 2017 by Dr. Tien Lee - **Focus**: Development of treatments for rare diseases, specifically in the metabolic space, including Prader-Willi syndrome and obesity [3][4] Pipeline and Research Focus - **Key Programs**: - **Prader-Willi Syndrome**: Lead compound ARD-101, a bitter taste receptor agonist targeting hunger pathways [4][5] - **Obesity**: ARD-201, a combination of ARD-101 and sitagliptin (Januvia), aimed at enhancing incretin release and prolonging their half-life [4][5] Mechanism of Action - **ARD-101**: Targets bitter taste receptors in the gut to release incretins (GLP-1 and CCK), signaling the brain to reduce hunger and appetite [4][5] - **ARD-201**: Combines the effects of ARD-101 with sitagliptin to enhance the incretin pathway and maintain weight loss [41][42] Clinical Trials - **Phase 3 Trial for Prader-Willi Syndrome**: Ongoing, with top-line data expected in Q3 2026 [10][11] - **Phase 2 Data**: Showed significant reduction in hyperphagia in most patients, with a focus on safety and tolerability [12][13] - **Hyperphagia Questionnaire (HQCT)**: Used to assess treatment efficacy, with a one-point difference considered clinically meaningful [17][18] Patient Demographics and Inclusion Criteria - **Age Range**: Phase 3 trial includes patients aged 10 and above, previously 13 and above, to target younger patients who experience hyperphagia earlier [20][21] - **Antipsychotic Use**: Patients on antipsychotics are included to ensure real-world representation, with 20%-30% of the Prader-Willi population typically using them [33][34] Geographic Distribution - **Trial Sites**: Approximately one-third of patients are from the U.S., with the remainder from countries including Canada, Australia, South Korea, and various EU nations [35] Quality Control Measures - **Assessment Consistency**: Caregivers and physicians remain consistent throughout the trial to minimize variability in HQCT scores [24][26] - **Blinded Checks**: Implemented to ensure quality control of assessments [26] Future Studies - **Weight Maintenance Study**: Anticipated preliminary data by the end of next year, focusing on maintaining weight after GLP-1 receptor agonist treatment [41][43] - **Weight Induction Study**: Aims to evaluate the effectiveness of ARD-201 in driving greater weight loss compared to existing treatments [50] Conclusion - Aardvark Therapeutics is positioned to make significant advancements in the treatment of Prader-Willi syndrome and obesity through innovative drug mechanisms and robust clinical trial designs, with key data expected in the coming years [51][52]

Core Insights - Aardvark Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at treating metabolic diseases, particularly through the activation of innate homeostatic pathways [2] Company Overview - Aardvark is developing novel therapeutics designed to suppress hunger, specifically targeting conditions like Prader-Willi Syndrome (PWS) and other metabolic diseases [2] - The lead compound, ARD-101, is currently in Phase 3 clinical development for hyperphagia associated with PWS and is also being studied for hypothalamic obesity [2] - Aardvark is also working on ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, to address limitations of existing GLP-1 therapies for obesity and related conditions [2] Upcoming Events - Aardvark will present at the Piper Sandler 37th Annual Healthcare Conference in New York on December 3 at 8:00 a.m. ET [4] - The company will also present at the Evercore ISI 8th Annual Healthcare Conference in Miami on December 4 at 11:15 a.m. ET [4] - Live webcasts of these presentations will be available on the company's website, with archived recordings accessible for approximately one month [1]

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]