Aardvark Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and short-term investments totaled $60.3 million as of September 30, 2026, down from $73.9 million as of June 30, 2026.
• Research and development expenses were $15.7 million for the quarter ended September 30, 2026, compared to $13.7 million in the same period in 2025, representing a $1.9 million increase.
• General and administrative expenses were $4.0 million for the third quarter of 2026, matching the $4.0 million reported for the third quarter of 2025.
• Net loss was $19.2 million for the third quarter of 2026, compared to a net loss of $16.3 million for the third quarter of 2025.
• Total operating expenses were $19.7 million for the three months ended September 30, 2026, compared to $17.7 million in the prior year period.
• Loss from operations was $19.7 million for the quarter ended September 30, 2026, compared to $17.7 million in the same period in 2025.
• Total other income, net, was $0.5 million for the quarter ended September 30, 2026, compared to $1.4 million in the same period in 2025.
• Net loss per share (basic and diluted) was $0.88 for the quarter ended September 30, 2026, compared to $0.75 in the same period in 2025.
• Accumulated deficit increased to $(171.1) million as of September 30, 2026, from $(115.9) million as of December 31, 2025.
• Total assets were $64.8 million as of September 30, 2026, compared to $117.2 million as of December 31, 2025.

Guidance and Future Outlook:

• The Company expects to resume Prader-Willi Syndrome (PWS) clinical activities in 2027, subject to alignment with the FDA.
• A meeting with the FDA is scheduled for the first quarter of 2027 to discuss the proposed clinical development plan for ARD-101.
• Existing cash resources are projected to fund operations through 2027.
• The Company intends to provide further details on the development pathway following feedback from the upcoming FDA meeting.

Business Segments and Product Lines:

• The FDA lifted the clinical hold on the Investigational New Drug (IND) application for ARD-101 for the treatment of hyperphagia in PWS in October 2026.
• The FDA has agreed that Aardvark may conduct an open-label trial of ARD-101 at a dose of 200 mg twice daily in patients with PWS.
• Exploratory data from the terminated HERO trial and open-label extension (OLE) trial showed numerically greater reductions in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scores with ARD-101 compared to placebo.
• In the HERO trial, HQ-CT scores decreased in both treatment groups, with greater reductions for ARD-101 at Weeks 2, 4, and 8.
• In the HERO intent-to-treat population with baseline HQ-CT scores of 13 or greater, the mean improvement in Clinical Global Impression of Severity (CGI-S) scores was numerically greater with ARD-101 than placebo at every scheduled visit, including Week 12.
• In the OLE cohort, participants switching from placebo to ARD-101 had an average additional reduction of 6 points in HQ-CT scores after four weeks of treatment.
• Among all OLE participants, there was an average 11.8-point reduction in HQ-CT scores relative to baseline at the start of the HERO trial.
• ARD-101 was generally well tolerated; treatment-emergent adverse events occurred in 52% of ARD-101 participants and 50% of placebo participants in the HERO trial.
• One serious cardiac adverse event occurred in the HERO trial at 800 mg BID in a participant taking pitolisant; the FDA concurred this was due to a drug-drug interaction, as ARD-101 inhibits CYP2D6.
• The Company believes risks related to CYP2D6 inhibition can be managed through restricting or adjusting doses of concomitant medications that are CYP2D6 substrates.

Market and Competitive Landscape:

• The HERO trial was terminated early after randomizing 67 of the planned 90 participants, rendering efficacy data exploratory, observational, and inconclusive.
• The Company notes that limitations in interpreting data from the HERO trial and its OLE trial exist because they were terminated early and were not powered to assess efficacy.

Risks and Challenges:

• The FDA may not agree with the proposed Phase 3 program or may require additional studies.
• The timing of the FDA meeting or resumption of clinical activities may be delayed.
• There are uncertainties related to potential delays in the commencement, enrollment, and completion of clinical trials.
• There is a risk of additional safety findings, including cardiac safety and drug-drug interactions.
• The Company faces the risk that exploratory, subgroup, and uncontrolled analyses from the HERO trial may not be confirmed in future trials.
• There is a risk that capital resources may be used sooner than expected or may be insufficient to achieve anticipated milestones.
• The Company is dependent on third parties for manufacturing, shipping, and production of drug product for clinical and preclinical studies.
• The Company faces risks related to competition and its ability to obtain, maintain, and enforce intellectual property protection.

Management Commentary and Tone:

• Tien Lee, M.D., Founder and CEO, stated that the lifting of the clinical hold and FDA agreement to conduct an open-label trial are important steps toward resuming clinical development.
• Management expressed commitment to advancing ARD-101 for patients and families affected by PWS.
• The tone indicates confidence in the proposed clinical development plan and the ability to manage specific safety risks through regulatory measures.

Other Key Points:

• In October 2026, the Company appointed David Zhang, Ph.D., MBA, to its Board of Directors as an independent director.
• Dr. Zhang brings over 25 years of experience in clinical strategy, biostatistics, and regulatory submissions, including oversight of the CAMZYOS® New Drug Application at MyoKardia.
• The Company conducted FDA-required cardiac safety studies, including an ECG study in healthy volunteers and an in vitro cardiac sodium channel study, which showed no QRS or QT interval prolongation at doses of 200 mg or 400 mg BID.
• The Company previously underwent a workforce reduction in June 2026.
• The Company plans to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, with the SEC on or about the date of this release.