AARD

ARD-101 and ARD-201 programs on voluntary pause; further guidance expected in Q2 2026 $91.2 million in cash, cash equivalents and short-term investments as of March 31, 2026, supports projected operations into mid-2027 SAN DIEGO, May 07, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (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, today reported financial results for the first quarter ended March 31, 2026, and provided pipeline and business updates. “We have been working closely with the FDA to comprehensively evaluate the data following the reversible cardiac observations in the healthy volunteer trial and are committed to determining the best path forward for our programs, patients and the broader PWS community,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We remain focused on establishing a clear path forward for the Phase 3 HERO trial evaluating ARD-101 in PWS, our lead program, and look forward to providing an update in the second quarter.” Pipeline Updates In February 2026, the Company announced a voluntary pause in enrollment and dosing in the Phase 3 Hunger Elimination or Reduction Objective (HERO) and open-label extension (OLE) trials evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome (PWS) following unexpected reversible cardiac observations in a separate healthy volunteer trial (non-PWS individuals). The healthy volunteer trial was conducted as a routine additional cardiac safety study to satisfy anticipated requirements for a future New Drug Application (NDA) for ARD-101. No cardiac signals were observed in the prior Phase 1 or Phase 2 clinical trials, and preclinical studies did not predict the expectation of cardiac safety liabilities. Aardvark is conducting a comprehensive review of the data and is working closely with the U.S. Food and Drug Administration (FDA) to determine next steps for the ARD-101 program. Aardvark is on track to provide further guidance in the second quarter of 2026. Additionally, in March 2026, the Company voluntarily paused its development of ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor for the treatment of obesity and obesity-related conditions, and...

Voluntary pause of the Phase 3 HERO and OLE trials evaluating ARD-101 for the treatment of hyperphagia in individuals with Prader-Willi Syndrome, further guidance on the program expected in Q2 2026 ARD-201 obesity program, including POWER and STRENGTH trials, on voluntary pause pending next steps with ARD-101; further guidance on the program expected in Q2 2026 Clinical and preclinical data from ARD-101 program published in Molecular Metabolism $110.0 million in cash, cash equivalents and short-term investments as of December 31, 2025, supports projected operations into the second quarter of 2027 SAN DIEGO, March 23, 2026 (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, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided pipeline and business updates. “Patient safety will always be our highest priority, and we are actively engaging with the FDA with urgency to determine the best path forward for our programs. As we evaluate next steps, we want to thank the Prader-Willi Syndrome community for its collaboration throughout this process. The community’s strength and tenacity continue to inspire our work,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “With positive clinical data, an encouraging safety profile from previous trials and our recently developed understanding of the clear blood plasma exposure-response relationship with reversible cardiac QRS prolongation, we have confidence in ARD-101. We strongly believe that ARD-101 retains its potential as a differentiated therapeutic option for hyperphagia in individuals living with PWS. We hope to resume the PWS development program in a timely manner and expect to provide further guidance on each of our programs in the second quarter of 2026.” Pipeline Updates ARD-101 for Prader-Willi Syndrome (PWS) In February 2026, the company announced a voluntary pause in enrollment and dosing in the Phase 3 Hunger Elimination or Reduction Objective (HERO) and open-label extension (OLE) trials evaluating ARD-101 for the treatment of hyperphagia in individuals with PWS following unexpected reversible cardiac observations in a separate healthy v...

Aardvark has aligned with the FDA to reduce the minimum age of eligibility from 13 to 10 years old for pediatric patients in HERO, the Phase 3 trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS) New preclinical data presented at ObesityWeek 2025 demonstrates the potential of ARD-201 in enhanced glucose control, along with preservation of lean body mass, underscoring its opportunity in addressing key challenges in today’s obesity treatment landscape Oral ARD-201 shows potential for weight management after GLP-1RA discontinuation, supported by new promising preclinical results and ARD-101 clinical data $126.4 million in cash, cash equivalents, and short-term investments as of September 30, 2025, supports projected operations into 2027 SAN DIEGO, Nov. 13, 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, today reported financial results for the third quarter ended September 30, 2025, and provided pipeline and business updates. “During ObesityWeek, we highlighted new preclinical data demonstrating the potential of ARD-201 in enhanced glucose control, along with preservation of lean mass, underscoring its opportunity in addressing key challenges in today’s obesity treatment landscape. The data were met with encouraging feedback from Key Opinion Leaders who attended the meeting,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “We also presented clinical data on ARD-101 and preclinical data on ARD-201 demonstrating the potential of oral ARD-201 to attenuate weight gain, promote weight loss and help maintain weight after GLP-1RA discontinuation. We’re looking forward to advancing ARD-201 into two Phase 2 trials, POWER and STRENGTH, to further evaluate its potential for individuals living with metabolic obesity.” Clinical Program Updates ARD-101 for PWS In October 2025, Aardvark reached alignment with the FDA on a protocol amendment to change the minimum age of eligibility to participate in the Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with PWS trial from 13 to 10 years of age. This change broadens the eligible population for the trial and expands the potential tar...

Compelling new ARD-201 preclinical data informs optimized Phase 2 clinical development strategy of obesity programs: Phase 2 POWER trial of oral ARD-201 to focus on weight rebound in patients discontinuing GLP-1RA therapy, while Phase 2 STRENGTH trial to focus on durable weight loss as a monotherapy and in combination with GLP-1RA. Anticipated expansion of Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS) to include pediatric population younger than 13 years of age. $141.8 million in cash, cash equivalents, and short-term investments supports projected operations into 2027. SAN DIEGO, Aug. 13, 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, today reported financial results for the second quarter ended June 30, 2025, and provided pipeline and business updates. “Aardvark has made significant progress across our pipeline, and we are well-positioned to unlock the full potential of ARD-101 and ARD-201 across multiple studies in the year ahead," said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “Expansion of the Phase 3 HERO trial to include younger patients below the age of 13 would allow us to reach a larger segment of the PWS patient population through our registration label at launch and serve more patients in need. In addition, recent preclinical data from our ARD-201 obesity program strengthens our conviction in targeting hunger signaling pathways as a distinct and complementary approach to glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies, and we’re looking forward to further exploring the promising therapeutic profile of ARD-201 in the Phase 2 POWER and STRENGTH trials.” Clinical Program Updates ARD-101 for PWS With the support from the PWS community, combined with historical data showing that younger patients are more likely to benefit from early intervention, Aardvark intends to expand the Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with PWS to include patients under the age of 13. ARD-201 for Obesity Preclinical data announced on August 12, 2025 demonstrated that investigational oral obesity therapy ARD-201 not only significantl...

Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS); data readout expected in early 2026 $151.3 million in cash, cash equivalents, and short-term investments supports projected operations into 2027 SAN DIEGO, May 14, 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, today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. “We believe that there is a significant, untapped opportunity to target anti-hunger signaling to treat rare metabolic diseases and obesity. Our lead candidate, ARD-101, is intended to address hunger by lowering the discomfort of fasting without notably decreasing the desirability of food or inducing nausea,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “The Phase 3 HERO study of ARD-101 in PWS shows our commitment to addressing unmet needs in this community.” Summary of Business Highlights In February 2025, Aardvark successfully completed its initial public offering (IPO), raising $97.9 million in gross proceeds. After deducting underwriting discounts, commissions, and offering expenses, the Company received approximately $87.5 million in net proceeds. Aardvark’s stock began trading under the symbol “AARD” on February 13, 2025. Select First Quarter 2025 Financial Highlights Cash Position: As of March 31, 2025, Aardvark had cash, cash equivalents, and short-term investments of $151.3 million, which includes the net proceeds from the IPO in February 2025. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents, and short-term investments, together with the proceeds from the IPO, will be sufficient to fund projected operations into 2027. R&D Expenses: Research and development expenses were $7.8 million and $1.2 million for the quarter ended March 31, 2025 and 2024, respectively. The $6.6 million increase for the quarter ended March 31, 2025, resulted from increased development costs primarily related to ARD-101 and an increase in personnel-related expenses. G&A Expenses: General and administrative expenses were $2.7 million and $0.9 million for the quarter ended March...

Lead candidate ARD-101 demonstrated clinical activity and was generally well tolerated in a two-part Phase 2 trial in Prader-Willi Syndrome (PWS), with meaningful reductions in hyperphagia (up to a 16-point HQ-CT reduction, with an average reduction of approximately 8 points among subjects that followed trial protocol) observed during the 28-day dosing period. DEXA scans analysis from the PWS Phase 2 trial data measuring body composition indicated a trend toward decreased body fat (approximately 1.5%) and increased lean muscle (over 2%) following 28 days of ARD-101 dosing. Ongoing ARD-101 Phase 3 HERO trial to treat hyperphagia associated with PWS is expected to generate topline data in early 2026. Aardvark bolstered its cash runway through the successful completion of its Initial Public Offering (IPO) in February 2025. SAN DIEGO, March 31, 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, today reported financial results for the full year ended December 31, 2024, and provided business highlights. “Appetite represents a reward-based neurological drive and hunger represents a penalty or pain avoidance neurological drive. Many approved obesity medications, including GLP-1RA agents, primarily regulate appetite, and Aardvark believes there is a significant, untapped opportunity to target anti-hunger signaling to treat metabolic rare diseases and obesity,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “ARD-101 is intended to address hunger by lowering the discomfort of fasting without notably decreasing the appeal of food or inducing nausea. We are pursuing certain medical conditions related to overeating or hyperphagia that may be primarily driven by hunger more than appetite, including Prader-Willi Syndrome, hypothalamic obesity, and at least some subsets of general obesity.” Summary of Business Highlights Phase 2 data for the treatment of hyperphagia associated with PWS showed multiple encouraging signals. As a result, Aardvark has advanced its clinical pipeline with the initiation of the potentially pivotal Phase 3 HERO (Hunger Elimination or Reduction Objective) trial evaluating ARD-101 for hyperphagia associated with PWS. Achi...