AARD

This article first appeared on GuruFocus. Release Date: August 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Aardvark Therapeutics Inc (NASDAQ:AARD) successfully held its 2026 Annual Meeting with a quorum of 54.79% of shares represented, ensuring corporate governance continuity. The stockholders re-elected Dr. Jeffrey Chi and Victor Tong Jr. as Class I directors, providing stable leadership through 2029. The appointment of BDO USA as the independent auditor for 2026 was ratified, maintaining financial oversight credibility. The repricing of certain stock options was approved, which may help retain and incentivize employees and management. The meeting was conducted efficiently with no stockholder questions or objections, indicating smooth operations and shareholder satisfaction. The meeting was primarily procedural with no substantive business or strategic updates, offering limited insight into company performance. The low quorum of 54.79% suggests potential shareholder disengagement or lack of interest in governance matters. The need for stock option repricing may indicate previous option grants were underwater, reflecting past stock price underperformance. No questions were received from stockholders, which could signal a lack of active engagement or concerns about the company's direction. The transcript provides no financial or operational details, leaving investors without new information on Aardvark Therapeutics Inc (NASDAQ:AARD)'s progress or outlook. Warning! GuruFocus has detected 2 Warning Signs with AARD. Is AARD fairly valued? Test your thesis with our free DCF calculator. Q: What were the key proposals voted on during the 2026 Annual Meeting of Stockholders?A: Tien Lee, CEO, and Nelson Sun, CFO/COO, presented three main agenda items: the election of two Class I directors, the ratification of BDO USA as the independent auditor for the year ending December 31, 2026, and the approval of the repricing of certain stock options under the company's 2017, 2025 Equity Incentive Plans, and 2025 Inducement Equity Incentive Plan. Q: Who were the nominees for the Class I director positions, and what was the outcome?A: The Board nominated current directors Jeffrey Chi, PhD, and Victor Tong, Jr. for Class I director positions. Nelson Sun reported that the Inspector of Election confirmed both Dr. Chi and Mr. Tong were elected to serve until the 2029 Annual Meeting of Stockholders. Q: Was the appointment of the company's independent registered public accounting firm ratified?A: Yes. Nelson Sun confirmed that the stockholders approved the ratification of BDO USA as the company's independent registered public accounting firm and independent auditor for the fiscal year ending December 31, 2026. Q: Did stockholders approve the repricing of certain stock options?A: Yes. The proposal to reprice certain stock options granted under the 2017 Equity Incentive Plan, the 2025 Equity Incentive Plan, and the 2025 Inducement Equity Incentive Plan was approved by the stockholders. Q: What was the stockholder turnout for the meeting, and was a quorum established?A: Nelson Sun reported that approximately 54.79% of the issued and outstanding shares of common stock were represented at the meeting, which was sufficient to constitute a quorum, allowing the meeting to proceed with the business agenda. Q: When will the final voting results be made available to the public?A: Nelson Sun stated that a final tally of the votes would be published in a current report on Form 8-K filed with the Securities and Exchange Commission on or before August 20, 2026. Q: Were there any stockholder questions or proposals submitted during the meeting?A: Tien Lee noted that the company did not receive any other stockholder proposals for the annual meeting, and no questions were submitted regarding the agenda items during the meeting itself. Q: What was the record date for stockholders entitled to vote at the meeting?A: The Board of Directors set June 18, 2026, as the record date for the meeting. The proxy materials were mailed to stockholders of record as of that date on July 13, 2026. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Assessing unblinded Phase 3 HERO and OLE data for ARD-101 in PWS in the third quarter of 2026 to support an informed determination of next steps Remains in active discussions with the FDA to support resolution of the clinical hold for ARD-101 program $73.9 million in cash, cash equivalents and short-term investments as of June 30, 2026, supports projected operations into late 2027 SAN DIEGO, Aug. 11, 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 second quarter ended June 30, 2026, and provided pipeline and business updates. “Patients and families in the PWS community are at the center of every decision we make, and our team is laser focused on establishing a clear path forward for ARD-101 in PWS,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “Over the last several months, we have continued to work collaboratively with the FDA. Additionally in the third quarter of this year, we are assessing the unblinded data from the HERO and OLE trials, which will allow us to understand the totality of the efficacy and safety results generated to date.” Pipeline Updates Aardvark is assessing the unblinded clinical data accumulated to date across both the HERO (Hunger Elimination or Reduction Objective) trial and the OLE (Open Label Extension) trial to assess the totality of available efficacy and safety data and to support an informed determination of next steps for the ARD-101 program. In June 2026, the Company terminated the HERO and the OLE trial and does not currently intend to resume these trials as previously designed. In May 2026, the Company announced that the U.S. Food and Drug Administration (FDA) placed a full clinical hold on its investigational new drug application (IND) for ARD-101, related to the Company’s previously announced voluntary pause. The clinical hold applies to all previously ongoing clinical studies under the IND, including the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS) and the Phase 3 OLE trial. Second Quarter 2026 Financial Highlights Cash Position: As of June 30, 2026, Aardvark had cash, cash equivalents and short-term investments of $73.9 million, compared to $91.2 million as of March 31, 2026. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into late 2027. Research & Development (R&D): R&D expenses for the second quarter of 2026 were $10.5 million, compared to $13.1 million for the second quarter of 2025. The $2.7 million decrease for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 resulted primarily from a decrease of $3.3 million for external expenses incurred for CMC, clinical and toxicology studies primarily related to the development of ARD-101 as a result of the voluntary pause of all of our clinical trials and the subsequent clinical hold on our IND for ARD-101, offset by a $0.7 million increase in personnel-related costs due to increased headcount and bonuses prior to the workforce reduction implemented in June 2026. General & Administrative (G&A): G&A expenses for the second quarter of 2026 were $4.6 million, compared to $2.7 million for the second quarter of 2025. The $1.9 million increase for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 included additional public company operating costs and resulted primarily from an increase in personnel-related costs due to year-over-year increased headcount prior to the workforce reduction implemented in June 2026 associated with the voluntary pause of all of our clinical trials and the subsequent clinical hold on our IND for ARD-101, bonuses and $0.5 million in severance expense. Net loss: Aardvark reported a net loss of $14.4 million for each of the second quarters of 2026 and 2025. About Aardvark Therapeutics, Inc.Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. For more information, visit www.aardvarktherapeutics.com. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, paused clinical trials, planned clinical trials, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding Aardvark’s anticipated cash runway, Aardvark’s discussions with the FDA, Aardvark’s unblinding and assessment of HERO and OLE trial data, and Aardvark’s future plans for its PWS program. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, recommencement, enrollment and completion of clinical trials and any additional actions that may be required by the FDA; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; the possibility that the past track records of Aardvark and its personnel may not be repeated or indicative of future success; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Investor and Media Contact:Courtney MogerleyArgot Partners(212) [email protected]

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 expects to provide further guidance in the second quarter of 2026. Phase 2 and Preclinical Data From ARD-101 Program Published in Molecular Metabolism In March 2026, clinical and preclinical data for the ARD-101 program were published in the peer-reviewed journal Molecular Metabolism. The publication details findings from the Phase 2 proof-of-concept obesity study demonstrating that ARD-101 significantly reduced self-reported hunger on the Control of Eating Questionnaire (CoEQ) at Day 28 versus placebo, with directionally favorable improvements observed across additional CoEQ domains. Also included in the published manuscript is a separate double-blind study in fasted healthy participants, where ARD-101 increased post-dose peptide YY (PYY) and glucagon-like peptide-1 (GLP-1), with trends toward increased cholecystokinin (CCK) and reduced ghrelin versus placebo – supporting engagement of gut–brain pathways relevant to hunger and hyperphagia. First Quarter 2026 Financial Highlights Cash Position: As of March 31, 2026, Aardvark had cash, cash equivalents and short-term investments of $91.2 million, compared to $110.0 million as of December 31, 2025. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into mid-2027. Research & Development (R&D): R&D expenses for the first quarter of 2026 were $16.6 million, compared to $7.8 million for the first quarter of 2025. The $8.8 million increase for the first quarter of 2026 as compared to the first quarter of 2025 resulted primarily from an increase of $7.1 million for external expenses incurred related to the development of ARD-101 and a $1.7 million increase in personnel-related costs. General & Administrative (G&A): G&A expenses for the first quarter of 2026 were $5.9 million, compared to $2.7 million for the first quarter of 2025. The $3.2 million increase for the first quarter of 2026 as compared to the first quarter of 2025 included additional public company operating costs and resulted primarily from a $2.1 million increase in personnel-related costs, a $0.6 million increase in legal, accounting and other professional services costs, and a $0.3 million increase in facilities and other costs. Net loss: Aardvark Therapeutics reported a net loss of $21.6 million for the first quarter of 2026, compared to a net loss of $9.3 million for the first quarter of 2025. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions. For more information, visit www.aardvarktherapeutics.com. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, ongoing clinical trials, planned clinical trials, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding the voluntary pauses on Aardvark’s clinical trials, Aardvark’s anticipated cash runway, Aardvark’s engagement with the FDA, Aardvark’s future plans for its PWS and obesity programs and statements regarding ARD-101 and ARD-201, including the expected timeline for providing further guidance on these programs. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, recommencement, enrollment and completion of clinical trials and any additional actions that may be required following Aardvark’s engagement with the FDA; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; the possibility that the past track records of Aardvark and its personnel may not be repeated or indicative of future success; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Investor Contact: Courtney Mogerley Argot Partners (212) 600-1902 [email protected] Media Contact: Andrea Cohen Sam Brown LLC (917) 209-7163 [email protected]

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 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. Two of eight participants experienced increases in QRS duration greater than 25% from baseline, and one additional participant had a QRS increase of less than 25% from baseline. A finding of QRS duration greater than 25% of baseline was considered significant per protocol. These participants in the healthy volunteer study were dosed at 1,600 mg twice daily without prior dose escalation, representing twice the target dose used in the HERO study (800 mg twice daily). The dosing in this healthy volunteer study is also in contrast to the dose-escalation approach used in the HERO trial, where patients received ARD-101 in a stepwise dose escalation: first at 200 mg twice daily for one week, then 400 mg twice daily for one week, then 800 mg twice daily for 10 weeks. All QRS increases were not reported as serious adverse events, were not accompanied by serious cardiac symptoms, and were reversible upon drug discontinuation and without medical intervention. The company subsequently conducted a trial with a follow-on cohort in healthy volunteers at a dose of 800 mg twice daily for up to one week, also without prior dose escalation, in which one of 23 participants experienced a transient increase in QRS duration of less than 25% from baseline, and one additional participant experienced an increase in QRS duration of greater than 25% from baseline. Again, these observations were not reported as serious adverse events, were not accompanied by serious cardiac symptoms, and were reversible with drug discontinuation without medical intervention. Preliminary analysis of data from this healthy volunteer study indicates a clear exposure-response relationship where higher plasma concentrations are associated with an increased risk of QRS prolongation. For example, in exposure-response modeling, a 200 mg twice daily dose yields plasma concentrations substantially below the threshold where QRS effects are observed. 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. The company expects to provide further guidance in the second quarter of 2026. Clinical and Preclinical Data From ARD-101 Program Published in Molecular Metabolism In March 2026, clinical and preclinical data for the ARD-101 program were published in the peer-reviewed journal Molecular Metabolism. The publication details findings from the Phase 2 proof-of-concept obesity study demonstrating that ARD-101 significantly reduced self-reported hunger on the Control of Eating Questionnaire (CoEQ) at Day 28 versus placebo, with directionally favorable improvements observed across additional CoEQ domains. In adults with obesity treated with ARD-101 (200 mg twice daily) for 28 days, CoEQ hunger decreased by 1.63 points versus 0.65 points with placebo. Also included in the published manuscript is a separate double-blind study in fasted healthy participants, where ARD-101 increased post-dose peptide YY (PYY) and glucagon-like peptide-1 (GLP-1), with trends toward increased cholecystokinin (CCK) and reduced ghrelin versus placebo – supporting engagement of gut–brain pathways relevant to hunger and hyperphagia. Together, these effects on clinical hunger signals and gut-hormone findings, combined with data from preclinical models of metabolic dysfunction, support Aardvark’s continued evaluation of ARD-101 as a potential therapy for pathological hunger and hyperphagia, including in PWS. The full online publication can be accessed here. ARD-201 for Obesity While Aardvark conducts a comprehensive review of the data and is actively engaging with the FDA, the company has also voluntarily paused the ARD-201 trials. This voluntary pause includes the Phase 2 Prevention of Weight Regain (POWER) trial evaluating a fixed dose combination of ARD-101 and a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of obesity in the prevention of weight regain among patients who have successfully lost approximately 15% of body weight on GLP-1RA therapy, and the Phase 2 Sitagliptin and TAS2R for Weight Reduction with Exercise, Nutrition, and GLP-1RA Trial and Hunger Assessment (STRENGTH) trial to evaluate placebo-adjusted weight loss and the additive effects of ARD-201 combined with GLP-1RA. Aardvark expects to provide further guidance on the program in the second quarter of 2026. Fourth Quarter and Full Year 2025 Financial Highlights Cash Position: As of December 31, 2025, Aardvark had cash, cash equivalents and short-term investments of $110.0 million, compared to $73.7 million as of December 31, 2024. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into the second quarter of 2027. Research & Development (R&D): R&D expenses for the fourth quarter of 2025 were $14.3 million, compared to $8.1 million for the fourth quarter of 2024. R&D expenses were $48.9 million for the year ended December 31, 2025, compared to $17.4 million for the year ended December 31, 2024. The $31.6 million increase for the year ended December 31, 2025 as compared to the year ended December 31, 2024 resulted primarily from an increase of $23.4 million for external expenses incurred primarily related to the development of ARD-101 and a $7.7 million increase in personnel-related costs. General & Administrative (G&A): G&A expenses for the fourth quarter of 2025 were $4.4 million, compared to $1.4 million for the fourth quarter of 2024. G&A expenses were $13.8 million for the year ended December 31, 2025, compared to $5.3 million for the year ended December 31, 2024. The $8.5 million increase for the year ended December 31, 2025 as compared to the year ended December 31, 2024 included additional public company operating costs and resulted primarily from a $4.5 million increase in personnel-related costs, a $2.4 million increase in legal, accounting and other professional services costs, a $0.7 million increase in facilities and other costs, and a $0.6 million increase in insurance costs. Net loss: Aardvark reported a net loss of $17.6 million for the fourth quarter of 2025, compared to a net loss of $8.8 million for the fourth quarter of 2024. Aardvark reported a net loss of $57.6 million for the year ended December 31, 2025, compared to a net loss of $20.6 million for the year ended December 31, 2024. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for obesity and obesity-related conditions. For more information, visit www.aardvarktherapeutics.com. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, ongoing clinical trials, planned clinical trials, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding the voluntary pauses on Aardvark’s clinical trials, Aardvark’s anticipated cash runway, Aardvark’s engagement with the FDA, Aardvark’s future plans for its PWS and obesity programs and statements regarding ARD-101 and ARD-201, including the expected timeline for providing further guidance on these programs. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, recommencement, enrollment and completion of clinical trials and any additional actions that may be required following Aardvark’s engagement with the FDA; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; the possibility that the past track records of Aardvark and its personnel may not be repeated or indicative of future success; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Annual Report on Form 10-K for the year ended December 31, 2025 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Investor Contact: Courtney Mogerley Argot Partners (212) 600-1902 [email protected] Media Contact: Andrea Cohen Sam Brown LLC (917) 209-7163 [email protected]

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 target market within the PWS market. In addition, during the third quarter of 2025, Aardvark commenced enrollment for the HERO Open Label Extension (OLE) trial and initiated its first clinical trial sites in Australia with a minimum age of eligibility to participate at 10 years of age. The OLE trial is available to patients completing the HERO clinical trial. ARD-201 for Obesity At ObesityWeek 2025, Aardvark presented preclinical data on ARD-201 and clinical data on ARD-101 supporting the continued development of ARD-201 to attenuate weight gain, promote weight loss, and help maintain weight after the discontinuation of glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies. In addition, ARD-201 improved glucose tolerance and lean body mass composition. Highlights from the data presented included: Preclinical – ARD-201 (Validated Diet-Induced Obesity (DIO) Mouse Model): Transition from high-dose tirzepatide to ARD-201 preserved lean mass Transition to ARD-201 achieved glucose control comparable to staying on high-dose tirzepatide, while a combination of ARD-201 with low-dose tirzepatide further enhanced glucose clearance Previously reported preclinical data demonstrated ARD-201 reduced body weight by ~19% after 30 days, which was comparable to high-dose tirzepatide Previously reported preclinical data demonstrated ARD-201 achieved ~30% weight loss when combined low-dose tirzepatide Clinical – ARD-101 (Randomized, 28-Day, Placebo-Controlled, Phase 2A Study in Adults with Obesity): ARD-101 showed signals of weight control, reduced hunger, and improved metabolic parameters, particularly among participants with elevated baseline values ARD-101 was well tolerated, with no serious adverse events or treatment discontinuations, reflecting a distinct profile from the effects associated with current anti-obesity therapies Anticipated Milestones Topline data from the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia associated with PWS is expected in the third quarter of 2026 Preliminary or interim data from the Phase 2 POWER trial is anticipated to be available in 2H 2026. Select Third Quarter 2025 Financial Highlights Cash Position: As of September 30, 2025, Aardvark had cash, cash equivalents, and short-term investments of $126.4 million. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents, and short-term investments will be sufficient to fund projected operations into 2027. R&D Expenses: Research and development expenses were $13.7 million and $4.1 million for the quarter ended September 30, 2025, and 2024, respectively. The $9.7 million increase for the quarter ended September 30, 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 $4.0 million and $1.0 million for the quarter ended September 30, 2025, and 2024, respectively. The $2.9 million increase for the quarter ended September 30, 2025, primarily resulted from increases in personnel-related costs, facilities and other costs, and professional fees, which were partially related to commencing operations as a public company in February 2025. Net loss: Net loss for the quarter ending September 20, 2025, was $16.3 million compared to $4.2 million quarter ending September 20, 2024, primarily due to increased research and development and general and administrative expenses. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food). Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. Aardvark is also developing ARD-201, a planned fixed-dose combination of ARD-101 with a DPP-4 inhibitor and conducting two separate trials with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit www.aardvarktherapeutics.com. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting interim, preliminary or topline results, anticipated cash runway, likelihood of success, as well as plans and objectives of management for future operations. Words including, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “promising,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding ARD-101, including the expected timeline for receiving topline data from the Phase 3 HERO trial; ARD-201’s potential, including its potential in enhanced glucose control, preservation of lean body mass, attenuation of weight gain, promotion of weight loss and maintaining weight after GLP-1RA discontinuation; and the expected timing for reporting preliminary or interim data from the Phase 2 POWER trial. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and production of drug product for use in clinical and preclinical trials; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law. Contact: Carolyn Hawley, Inizio Evoke Comms (619) 849-5382 [email protected]

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 significantly reduced body weight, but also helped prevent weight regain (weight rebound) after discontinuation of GLP-1RA. Driven by these new preclinical insights, Aardvark is advancing ARD-201 in two Phase 2 trials, the POWER and STRENGTH trials, in place of the previously planned EMPOWER trial. Updated Milestones Topline data from the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia associated with PWS is expected in the third quarter of 2026. Initiation of the Phase 2 POWER trial evaluating ARD-201’s potential to prevent weight regain in subjects who discontinue GLP-1RA therapy after achieving substantial prior weight loss (~15%) is expected in the second half of 2025. Initiation of the Phase 2 STRENGTH trial evaluating placebo-adjusted weight loss and the additive effects of ARD-201 combined with GLP-1RA therapy is expected in the first half of 2026. Initiation of the Phase 2 HONOR trial evaluating ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025 with anticipated topline data readout in the second half of 2026. Summary of Business Highlights In May 2025, Aardvark bolstered its leadership team with strategic hires across scientific, commercial, regulatory and legal functions with the appointments of Timothy Kieffer, Ph.D., as Chief Scientific Officer; Danny Villeneuve as Chief Commercial Officer; Terrie Kellmeyer, Ph.D., as Senior Vice President, Regulatory Affairs; and Christian Zapf, J.D., as General Counsel. In June 2025, Aardvark presented previously disclosed data from its Phase 2 trial of ARD-101 in PWS in a poster and a five-minute “lightning” oral presentation at the 2025 United in Hope Conference. In addition, Aardvark’s Chief Medical Officer, Manasi Jaiman, M.D., participated in a panel with clinicians to discuss the details of the company’s ongoing Phase 3 HERO trial. Select Second Quarter 2025 Financial Highlights Cash Position: As of June 30, 2025, Aardvark had cash, cash equivalents, and short-term investments of $141.8 million. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents, and short-term investments will be sufficient to fund projected operations into 2027. R&D Expenses: Research and development expenses were $13.1 million and $4.0 million for the quarter ended June 30, 2025, and 2024, respectively. The $9.1 million increase for the quarter ended June 30, 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 $2.0 million for the quarter ended June 30, 2025, and 2024, respectively. The $0.7 million increase for the quarter ended June 30, 2025, primarily resulted from increases in professional fees, facilities and other and personnel-related costs, which were partially related to commencing operations as a public company. Net loss: Net loss was $14.4 million and $5.4 million for the quarter ended June 30, 2025, and 2024, respectively, primarily due to increased research and development and general and administrative expenses. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of PWS and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food). Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. ARD-101 is also being studied in hypothalamic obesity. Additionally, Aardvark is developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, and conducting two separate trials, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, anticipated cash runway, likelihood of success, as well as plans and objectives of management for future operations. Words including, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “promising,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding ARD-101, including the anticipated expansion of the Phase 3 HERO trial for the treatment of hyperphagia associated PWS to include pediatric population younger than 13 years of age and the expected timeline for receiving topline data from the Phase 3 HERO trial; ARD-201’s potential, including its potential as a monotherapy and in combination with GLP-1RA and its promising therapeutic profile; and the trial design for the POWER and STRENGTH trials and the expected timing for commencing such trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and production of drug product for use in clinical and preclinical trials; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contact: Carolyn Hawley, Inizio Evoke Comms (619) 849-5382 [email protected]

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 31, 2025, and 2024, respectively. The $1.9 million increase for the quarter ended March 31, 2025, primarily resulted from increases in professional fees, facilities and other and personnel-related costs, which were partially related to commencing operations as a public company. Net loss: Net loss was $9.3 million and $2.2 million for the quarter ended March 31, 2025, and 2024, respectively. About Aardvark Therapeutics, Inc. Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of PWS and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food). Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. ARD-101 is also being studied in hypothalamic obesity. Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, anticipated cash runway, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and clinical and preclinical trials; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contact: Carolyn Hawley, Inizio Evoke Comms (619) 849-5382 [email protected]

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. Achieved a successful IPO with $97.9 million in gross proceeds to support ongoing and future pipeline development. Strengthened executive leadership with the addition of Manasi Sinha Jaiman, M.D., M.P.H., a proven clinical strategist, as Chief Medical Officer. Enhanced board expertise with the appointment of Roy D. Baynes, M.D., Ph.D., and Susan E. Graf, RPh, MBA, to the Board of Directors. Anticipated Milestones Initiation of the Phase 2 HONOR trial of ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025.​ Initiation of the Phase 2 EMPOWER trial of ARD-201 for the treatment of obesity and obesity-related conditions as a fixed-dose combination of ARD-101 with a dipeptidyl peptidase-4 (DPP-4) inhibitor is expected in the second half of 2025. Topline data from the Phase 3 HERO trial for the treatment of hyperphagia associated with PWS is expected in early 2026. Select Full Year 2024 Financial Highlights Cash Position: As of December 31, 2024, Aardvark had cash, cash equivalents, and short-term investments of $73.7 million, which does not include the proceeds from our IPO in February 2025. Based on current operating plans, Aardvark believes that our existing cash, cash equivalents, and short-term investments, together with the proceeds from our IPO, will be sufficient to fund projected operations into 2027. R&D Expenses: Research and development expenses were $17.4 million and $4.5 million for the year ended December 31, 2024 and 2023, respectively. The $12.9 million increase for the year ended December 31, 2024, resulted from increased development costs primarily related to ARD-101 and an increase in personnel-related expenses. G&A Expenses: G&A expenses were $5.3 million and $2.2 million for the year ended December 31, 2024, and 2023, respectively. The $3.1 million increase for the year ended December 31, 2024, primarily resulted from increases in personnel-related costs and other professional costs. Net loss: Net loss was $20.6 million and $7.2 million for the year ended December 31, 2024, and 2023, respectively. About Aardvark Therapeutics, Inc.Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of PWS and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food), our programs explore therapeutic applications in hunger associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. ARD-101 is also being studied in hypothalamic obesity. Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com. Forward-Looking StatementsStatements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, anticipated cash runway, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and clinical and preclinical trials; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Aardvark’s Annual Report on Form 10-K for the year ended December 31, 2024 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Contact: Carolyn Hawley, Inizio Evoke Comms(619) [email protected]