Aardvark Therapeutics, Inc. · NASDAQ:AARD
Aardvark Therapeutics — Technical Presentation (October 2026)
26 slides from Aardvark Therapeutics's technical presentation, Oct 23, 2026
Slide 1: HERO/OLE Update
HERO/OLE Update EXHIBIT 99.2
Slide 2: Disclaimer
Disclaimer Aardvark Therapeutics, Inc. (“we”, “us,” “our” or the “Company”) does not (nor its respective affiliates, directors, members, officers, employees or agents) make any representation or warranty, express or implied, as to, and no reliance should be placed on, the fairness, accuracy, complet
Slide 3: ARD-101 Prader-Willi Syndrome (PWS) Program
ARD-101 Prader-Willi Syndrome (PWS) Program Clinical proof-of-concept in hyperphagia, Phase 3 learnings, and a dedicated thorough QT study AUG 2020 PHASE 1 SAD/MAD Trials NOV 2021 PHASE 2 Two Phase 2 Trials SEP 2024 PHASE 2 Open-Label Trial 18 participants completed dosing* Overall 8.5-point HQ-CT s
Slide 4: Executive Summary
Executive Summary Clinical signals demonstrate rapid ARD-101 benefit, with a well-tolerated safety profile despite early trial termination. 1 HERO stopped early, enrollment truncated Did not reach the planned “n”, results should be considered exploratory Convergence of signals, directionality 2 Earl
Slide 5: Cardiac Safety: ECG and DDI Findings
Cardiac Safety: ECG and DDI Findings Across all studies No increases in QTc were observed at any dose in the healthy volunteer studies. No QRS findings were observed in available ECGs from the PWS studies. Drug-Drug Interaction (DDI) At 800 mg BID, ARD-101 is a strong inhibitor of CYP2D6, which may
Slide 6: HERO and OLE Trial Design
HERO and OLE Trial Design ARD-101 in PWS with Hyperphagia | Phase 3 HERO and OLE Trial Designs PHASE 3 HERO | 12-WEEK RANDOMIZED DOUBLE-BLIND TRIAL Key Eligibility PWS with hyperphagia ≥ 10 years old Stable and consistent caregiver RANDOMIZED 1:1 ARD-101 · n=45 Placebo · n=45 Endpoints PRIMARY Hyper
Slide 7: HERO and OLE Baseline Demographics
HERO and OLE Baseline Demographics HERO ITT (HQ-CT ≥13) OLE mITT1 Parameter Statistic Pooled (N=64) Placebo (N=32) ARD-101 (N=32) Pooled (N=19) Placebo (N=11) ARD-101 (N=8) Age, years Mean (SD) (range) 19.9 (7.2) (10–43) 19.4 (6.8) (11–43) 20.3 (7.6) (10–43) 21.5 (7.4) (13–41) 21.4 (8.4) (13–41) 21.
Slide 8: OLE mITT Population at Baseline
OLE mITT Population at Baseline Efficacy Parameter Treatment HERO Baseline Mean (SD) OLE Baseline Mean (SD) HQ-CT Score ARD-101 (n=8) 25.0 (7.3) 19.0 (10.0) Placebo (n=11) 20.4 (8.3) 14.4 (7.9) CGI-S Score ARD-101 (n=8) 5.1 (1.0) 4.5 (1.1) Placebo (n=11) 5.0 (0.6) 4.6 (0.9) CaGI-S Score ARD-101 (n=8
Slide 9: Change in HQ-CT Score During HERO and After Study Pause
HERO baseline mean HQ-CT score: ARD-101=22.5 Placebo=22.8 Change in HQ-CT Score During HERO and After Study Pause On ARD-101 or Placebo Withdrawal of ARD-101 or Placebo Data includes all participants (ITT) enrolled into the HERO study. No statistical adjustments were made for covariates, including
Slide 10: HERO Change in HQ-CT Score vs DESTINY PWS
HERO Change in HQ-CT Score FOR ILLUSTRATIVE PURPOSES ONLY: These observations are derived from separate clinical settings; comparisons across ARD-101 and VYKAT trials are not based on head-to-head studies; Differences exist between trial designs and participant characteristics, and strong caution sh
Slide 11: HQ-CT Score During HERO, OLE, and After Study Pause
HERO baseline mean HQ-CT score: ARD-101=25.0 Placebo=20.4 HQ-CT Score During HERO, OLE, and After Study Pause On ARD-101 or Placebo Withdrawal of ARD-101 Data includes all participants who completed the HERO study and were enrolled in the open-label extension (OLE) HQ-CT scores improved after switc
Slide 12: Efficacy Observations
Efficacy Observations A trend for improvement in hyperphagia was observed with ARD-101 A modest reduction in HQ-CT scores over placebo was observed with ARD-101 in HERO. Upon discontinuation of ARD-101, the HQ-CT score of the ARD-101-treatment group returned to near baseline while the placebo treate
Slide 13: Additional Assessments Reviewed: HERO
Additional Assessments Reviewed: HERO All prespecified assessments were collected and reviewed. No clear differences in responses to lipids, HbA1c, body weight/BMI; however, interpretation is limited as these would be long term effects and the HERO trial and OLE trial were stopped early. Assessment
Slide 14: Most Common Adverse Events for All Participants in HERO
Most Common Adverse Events for All Participants in HERO Adverse Event PT Overall # of participants reporting event (%) (N=67) # of ARD-101 participants reporting event (%) (N=33) # of Placebo participants reporting (%) (N=34) Diarrhoea 6 (9.0) 3 (9.1) 3 (8.8) Nasal congestion 6 (9.0) 3 (9.1) 3 (8.8)
Slide 15: Safety Summary — HERO & OLE
Safety Summary — HERO & OLE KEY MESSAGE Generally well tolerated. In the open-label extension, participants previously on ARD-101 had zero related adverse events. HERO N = 67 · 33 ARD-101 / 34 placebo 88 TEAEs; ~51% of all participants; majority mild–moderate. Related: 28 events in 12 pts (18%) — fe
Slide 16: Fireside Chat
Fireside Chat Manasi Jaiman, MD, MPH Chief Medical Officer Aardvark Therapeutics Lynne Bird, MD Medical Director, Prader-Willi Syndrome Clinic Rady Children’s Hospital | UC San Diego Perspectives on Prader-Willi Syndrome and Hyperphagia
Slide 17: Excited to be resuming clinical development!
Excited to be resuming clinical development!
Slide 18: Participant A
Participant A: Multiracial, Female, age 13 years Medical history: sleep apnea, growth hormone deficiency, hypothyroidism, allergy to penicillin, far sightedness, oculomotor dysfunction Randomized to ARD-101, completed HERO and rolled into the Open Label Extension Ended Treatment (OLE Study day 30 du
Slide 19: Participant B
Participant B: White, Male, age 20 years Medical history: Global Hypotonia, Myopia, Behavioral Outburst, Dry Eye, Nerve Pain, Hypercholesterolemia, Anxiety, Depression, Congenital Hypodontia, Growth Hormone Deficiency, Hypogonadism, Scoliosis, Excessive Daytime Sleepiness, Headaches, Effusion of Lef
Slide 20: Abbreviations
Abbreviations AE Adverse event ADaM Analysis Data Model BID Twice daily BMI Body mass index CaGI-C Caregiver Global Impression of Change CaGI-S Caregiver Global Impression of Severity CGI-C Clinical Global Impression of Change CGI-S Clinical Global Impression of Severity DB Double-blind DCCR Diazoxi
Slide 21: Questionnaires – HQ-CT, CaGI-S, CGI-S
Questionnaires – HQ-CT, CaGI-S, CGI-S Hyperphagia Questionnaire for Clinical Trials (HQ-CT) A 9-question clinical outcome assessment where each food-related problem behavior question has a scoring range from 0 (never, not at all, infrequent, etc.) to 4 (extremely, frequently, etc.). The maximum scor
Slide 22: HERO HQ-CT, CaGI-S and CGI-S Scores
HERO HQ-CT, CaGI-S and CGI-S Scores (ITT Population; HQ-CT ≥ 13) Baseline mean HQ-CT score: ARD-101 = 22.5 Placebo = 22.8 Baseline mean CaGI-S score: ARD-101=5.7 Placebo=5.5 Baseline mean CGI-S score: ARD-101=4.8 Placebo=4.9
Slide 23: HERO to OLE Mean Change in HQ-CT Score
HERO to OLE Mean Change in HQ-CT Score from HERO Baseline (OLE mITT Population; N=19) HERO baseline HQ-CT mean score: ARD-101=25.0 Placebo=20.4 HERO baseline CaGI-S mean score: ARD-101=6.0 Placebo=5.2 HERO baseline CGI-S mean score: ARD-101=5.1 Placebo=5.0
Slide 24: HERO Mean Change in HQ-CT, CaGI-S, CGI-S Scores Following Study Pause
HERO Mean Change in HQ-CT, CaGI-S, CGI-S Scores Following Study Pause (HERO ITT; HQ-CT ≥ 13) Baseline mean HQ-CT Score: ARD-101 = 22.5 Placebo = 22.8 Mean time from last dose [Mean(Min-Max)]: Early Term Visit [(9 days(1-31)], 2-Week Follow Up Visit [24 days(13-52)], 4-Week Follow Up Visit [39 days
Slide 25: OLE Mean Change in HQ-CT, CaGI-S, CGI-S Scores Following Study Pause
HERO Baseline mean score: ARD-101=25.0 Placebo=20.4 Mean time from last dose [Mean(Min-Max)]: Early Term Visit [7 days(1-26)], 2-Week Follow Up Visit [20 days(17-34)], 4-Week Follow Up Visit [35 days(31-47)] OLE Mean Change in HQ-CT, CaGI-S, CGI-S Scores Following Study Pause (OLE mITT Population; N
Slide 26: Change in HQ-CT Score Waterfall (OLE mITT Population)
Change from start of ARD-101 treatment Change was calculated using baseline prior to ARD-101 treatment and ending with last score either prior to pause or within 4 days of the end of treatment date *Total N=19 for mITT, 1 removed due to PD during 302 study (9 point increase of HQ-CT score in 302) Ch
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