Aardvark Therapeutics Reports Q2 Loss

Aardvark Therapeutics (AARD 11.55%), a clinical-stage biopharmaceutical company developing new treatments for rare and metabolic diseases, reported its financial results on August 13, 2025. The most notable aspect of the release was the continued lack of revenue, as the company stays pre-commercial, combined with a net loss per share of $(0.66) (GAAP). The net loss (GAAP) increased to $14.4 million driven mainly by sharply higher research and development costs. Overall, the period demonstrated progress across Aardvark’s clinical pipeline, but also highlighted a rapidly accelerating expense base. The company’s cash position at quarter-end was $141.8 million, which it expects will fund operations into 2027.

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Strategic Focus

Aardvark Therapeutics develops therapies aimed at treating rare hyperphagic, or excessive hunger-related, conditions and challenging metabolic diseases. Its pipeline focuses on two main assets: ARD-101 for Prader-Willi syndrome (PWS) and hypothalamic obesity (HO), and ARD-201 for obesity, including situations where patients face weight rebound after stopping conventional obesity medications.

For Aardvark, the main goal is moving its drug candidates successfully through clinical trials and gaining regulatory approval. Trial success directly impacts the path to market for its treatments. Another key factor is competitive positioning, particularly its approach of targeting hunger signaling pathways, which stands apart from current glucagon-like peptide-1 receptor agonist (GLP-1RA) drugs. Building strategic partnerships and addressing gaps in current obesity treatments are central themes for the business.

Quarterly Highlights: Operational and Pipeline Progress

This quarter, Aardvark advanced its clinical programs, most notably by expanding the Phase 3 HERO study for ARD-101. Aardvark plans to expand the Phase 3 HERO study for ARD-101 to include patients under age 13, increasing its addressable patient base should it win approval. A new Phase 2 clinical trial for ARD-101, named HONOR, was also announced, targeting patients with acquired hypothalamic obesity. The company expects initial results from HERO in the third quarter of 2026 and from HONOR in the second half of 2026.

The POWER trial will focus on preventing weight rebound after stopping GLP-1RA therapy, while the STRENGTH trial will look at durable weight loss as both a stand-alone and combined treatment. The company pivoted away from a previously planned EMPOWER study, citing new preclinical data that demonstrated ARD-201’s effectiveness in prolonging weight loss and preventing weight regain after discontinuing GLP-1RA use. POWER is set to begin in the second half of 2025, and Initiation of STRENGTH is planned for the first half of 2026.

Management made several key hires in research, commercial, regulatory, and legal roles in May 2025. No fresh partnership or business development deals were disclosed this quarter, but management maintains that such collaborations are a strategic priority moving forward.

While there were no reported delays or negative trial updates in the period, the financial report highlighted a rapid increase in research and development spending. Research costs grew to $13.1 million (up 227.5%), primarily related to ARD-101 and increased personnel-related expenses. General and administrative expenses rose to $2.7 million for the quarter ended June 30, 2025, compared to $2.0 million in the same period of 2024, a 35% increase. The net loss (GAAP) widened to $14.4 million compared to $5.4 million in Q2 2024, reflecting this investment ramp. The company’s cash and short-term investments stood at $141.8 million as of June 30, 2025, which management projects will be adequate to fund operations into 2027 based on cash, cash equivalents, and short-term investments as of June 30, 2025. There were no one-time material events or dividend actions reported.

No revenue was generated during the period, and the company’s financial position relies entirely on capital raised over prior quarters. The number of shares outstanding has increased sharply to 21.7 million from 4.0 million compared to Q2 2024, mostly as a result of its recent public offering and capital raises. Accumulated deficit reached $82.0 million as of June 30, 2025.

Looking Ahead: Guidance and Investor Focus

Management did not provide specific financial guidance for the upcoming quarter or full fiscal year. However, it signaled that its cash position is expected to cover operations into 2027, including major readouts from the HERO, HONOR, POWER, and STRENGTH trials. The next pivotal events are topline HERO data in the third quarter of 2026, initiation of the POWER trial in the second half of 2025, and HONOR results in the second half of 2026.

With no commercial product revenue, future results will hinge on successful clinical outcomes, meeting regulatory requirements, and maintaining financial discipline. Investors are likely to focus on the pace of clinical trial progress, research spending versus cash resources, and AARD does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.