Full Press Release Details
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)
Clinical and Preclinical Data From ARD-101 Program Published inMolecular Metabolism
ARD-201 for Obesity
Fourth Quarter and Full Year 2025 Financial Highlights
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, visitwww.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, 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 MogerleyArgot Partners(212) 600-1902Aardvark@Argotpartners.com
Media Contact:Andrea CohenSam Brown LLC(917) 209-7163Andreacohen@Sambrown.com
| Aardvark Therapeutics, Inc.Consolidated Statements of Operations(in thousands, except share and per share amounts) | ||||||||||||||||
| Three Months EndedDecember 31, | Year EndedDecember 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 14,299 | $ | 8,062 | $ | 48,936 | $ | 17,363 | ||||||||
| General and administrative | 4,405 | 1,388 | 13,789 | 5,305 | ||||||||||||
| Credit loss—related party accounts receivable | — | — | — | 117 | ||||||||||||
| Total operating expenses | 18,704 | 9,450 | 62,725 | 22,785 | ||||||||||||
| Loss from operations | (18,704 | ) | (9,450 | ) | (62,725 | ) | (22,785 | ) | ||||||||
| Total other income (expense), net | 1,106 | 671 | 5,134 | 2,197 | ||||||||||||
| Net loss | $ | (17,598 | ) | $ | (8,779 | ) | $ | (57,591 | ) | $ | (20,588 | ) | ||||
| Net loss per share of common stock, basic and diluted | $ | (0.81 | ) | $ | (2.16 | ) | $ | (2.93 | ) | $ | (5.15 | ) | ||||
| Weighted-average shares used in net loss per share calculation | 21,782,325 | 4,062,566 | 19,624,626 | 3,996,376 |
| Aardvark Therapeutics, Inc.Consolidated Balance Sheets(in thousands, except share amounts) | ||||||||
| December 31, | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 47,051 | $ | 61,641 | ||||
| Short-term investments | 62,976 | 12,022 | ||||||
| Prepaid expenses and other current assets | 1,859 | 474 | ||||||
| Total current assets | 111,886 | 74,137 | ||||||
| Operating lease right-of-use asset | 355 | 735 | ||||||
| Other assets | 4,940 | 2,635 | ||||||
| Total assets | $ | 117,181 | $ | 77,507 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,072 | $ | 2,298 | ||||
| Accrued liabilities | 8,035 | 2,291 | ||||||
| Operating lease liability, current portion | 441 | 338 | ||||||
| Total current liabilities | 10,548 | 4,927 | ||||||
| Operating lease liability, net of current portion | — | 441 | ||||||
| Other long-term liabilities | — | 26 | ||||||
| Total liabilities | 10,548 | 5,394 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock | — | 126,756 | ||||||
| Stockholders’ equity (deficit): | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | — | — | ||||||
| Additional paid-in-capital | 222,470 | 3,684 | ||||||
| Accumulated other comprehensive income | 81 | — | ||||||
| Accumulated deficit | (115,918 | ) | (58,327 | ) | ||||
| Total stockholders’ equity (deficit) | 106,633 | (54,643 | ) | |||||
| Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) | $ | 117,181 | $ | 77,507 |