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Aardvark Therapeutics, Inc. is registering up to $400,000,000 of securities under a shelf registration, including up to $150,000,000 of its common stock that may be sold under an Equity Distribution Agreement with Piper Sandler & Co.
The prospectus covers common stock, preferred stock, debt securities, warrants, rights, units and depositary shares to be offered from time to time. The company’s common stock trades on Nasdaq under the symbol AARD and had a last reported sale price of $4.07 per share on March 20, 2026. The filing discloses that on February 27, 2026, Aardvark voluntarily paused enrollment and dosing in its HERO and OLE trials following reversible cardiac observations in a healthy volunteer study and is collaborating with the FDA to determine next steps; related ARD-201 trials are also paused while safety assessments continue.
Aardvark Therapeutics is a clinical-stage biopharma company developing small-molecule drugs that activate bitter taste receptors (TAS2Rs) to modulate hunger pathways for metabolic diseases. Its lead oral candidate, ARD-101, targets hyperphagia in Prader-Willi syndrome (PWS) via gut-localized CCK and GLP-1 release with minimal systemic exposure.
Phase 1 in healthy volunteers and an open-label Phase 2 PWS study showed ARD-101 was generally well-tolerated and reduced validated hyperphagia questionnaire scores, with trends toward lower body fat and higher lean mass. ARD-101 holds FDA Orphan Drug and Rare Pediatric Disease designations for PWS.
Aardvark started the Phase 3 HERO trial in December 2024 but voluntarily paused enrollment and dosing in February 2026 after reversible QRS prolongation was observed in a healthy volunteer cardiac safety study at high doses. Related ARD-201 Phase 2 POWER and planned STRENGTH obesity trials are also paused. The company is reviewing safety data and redesign options with the FDA and no longer expects HERO topline data in the third quarter of 2026, with further guidance planned in the second quarter of 2026.
Aardvark Therapeutics reported fourth quarter and full-year 2025 results and announced significant pipeline changes. The company has voluntarily paused enrollment and dosing in its Phase 3 HERO and OLE trials of ARD-101 for Prader-Willi Syndrome, and also paused its ARD-201 obesity trials, after reversible cardiac QRS prolongation was seen in high-dose healthy volunteer studies. Aardvark is working with the FDA and expects further guidance on both programs in the second quarter of 2026. As of December 31, 2025, it held $110.0 million in cash, cash equivalents and short-term investments, which it believes will fund operations into the second quarter of 2027. Full-year 2025 R&D expenses rose to $48.9 million and G&A expenses to $13.8 million, driving a net loss of $57.6 million, compared with a net loss of $20.6 million in 2024. The company also highlighted published clinical and preclinical ARD-101 data showing reduced hunger scores and favorable gut hormone changes in prior studies.
Aardvark Therapeutics has voluntarily paused its Phase 3 HERO trial of ARD-101 in Prader-Willi syndrome, along with the related open-label extension. The pause follows reversible cardiac observations at above target therapeutic doses seen during routine safety monitoring in a healthy volunteer study.
The company is conducting a comprehensive data review and has temporarily halted enrollment and dosing in HERO out of caution. As a result, Aardvark no longer expects to report topline HERO data in the third quarter of 2026 and plans to give updated timing guidance in the second quarter of this year.
Aardvark Therapeutics filed a current report describing leadership changes and the creation of a new dermatology-focused subsidiary. The company formed Ardia Therapeutics, a wholly owned U.S. unit that will develop DIA-615, a clinic-ready topical candidate for inflammatory skin diseases such as psoriasis.
Former Chief Operating Officer Bryan Jones, Ph.D., became Ardia’s Chief Executive Officer and entered a letter agreement covering salary through up to nine months after his transition, continued option exercisability while employed at Ardia, and accelerated vesting of 17,797 stock options plus monthly vesting of 2,542 additional options for three months. Nelson Sun, already Chief Financial Officer, was appointed Chief Operating Officer as well, with no material compensation change, and Derrick C. Li was named Chief Business Officer. The filing reiterates Aardvark’s core pipeline, including Phase 3 oral ARD-101 for Prader-Willi syndrome and Phase 2 combination candidate ARD-201 for obesity-related conditions.
Aardvark Therapeutics, Inc. reported that Chief Financial Officer Nelson Sun received a new stock option grant. On February 9, 2026, he was granted an option to buy 70,549 shares of common stock at an exercise price of $13.48 per share.
According to the vesting terms, one quarter of these option shares vest on February 9, 2027, with the remaining three quarters vesting in equal monthly installments over the following three years, so long as he remains in continuous service. After this grant, he beneficially owns 70,549 derivative securities directly.
Aardvark Therapeutics Chief Medical Officer receives stock option grant. Chief Medical Officer Manasi Jaiman was granted a stock option to buy 70,549 shares of Aardvark Therapeutics common stock at an exercise price of $13.48 per share on February 9, 2026.
The option vests over four years: one-quarter of the shares vest on February 9, 2027, and the remaining shares vest in equal monthly installments thereafter, subject to continued service. Following this grant, 70,549 derivative securities are beneficially owned directly.
Aardvark Therapeutics, Inc. director, chief executive officer, and 10% owner Lee Tien-Li reported receiving a stock option grant. On February 9, 2026, they were granted an option to buy 203,851 shares of common stock at an exercise price of $13.48 per share.
According to the vesting terms, one quarter of the option will vest on February 9, 2027, with the remaining three quarters vesting in equal monthly installments over the following three years, contingent on continued service. After this grant, 203,851 derivative securities are held directly.
Aardvark Therapeutics, Inc. announced U.S. Institutional Review Board approval of an amended protocol for its Phase 3 HERO trial of lead candidate ARD-101 in Prader-Willi Syndrome. The change lowers the minimum enrollment age from 10 to 7 years for U.S. participants.
The randomized, double-blind, placebo-controlled HERO study plans to enroll 90 patients across the U.S., Australia, Canada, the U.K. and South Korea, measuring change in Hyperphagia Questionnaire for Clinical Trials scores at Week 12 as the primary endpoint. Enrollment is described as progressing steadily, with topline data targeted for the third quarter of 2026.
Aardvark Therapeutics, Inc. filed a current report to note that on January 12, 2026 it updated its corporate presentation. The presentation, dated January 2026, is intended for meetings with investors, analysts and other stakeholders and will also be posted on the company’s website.
The updated corporate presentation is furnished as Exhibit 99.1 and is incorporated by reference into the Other Events section. The company states the presentation is current as of January 12, 2026 and disclaims any obligation to update this material in the future.