Aardvark Therapeutics Reports Second Quarter 2025 Financial Results and Provides Pipeline and Business Updates
Aardvark Therapeutics (NASDAQ:AARD) reported Q2 2025 financial results and provided significant pipeline updates. The company ended Q2 with $141.8 million in cash, supporting operations into 2027. Net loss increased to $14.4 million from $5.4 million year-over-year.
Key developments include plans to expand the Phase 3 HERO trial of ARD-101 for Prader-Willi Syndrome to include patients under 13 years old. New preclinical data for ARD-201 showed promising results in preventing weight rebound after GLP-1RA discontinuation, leading to two new Phase 2 trials: POWER and STRENGTH, replacing the previously planned EMPOWER trial.
The company strengthened its leadership team with strategic appointments across scientific, commercial, regulatory, and legal functions.
Aardvark Therapeutics (NASDAQ:AARD) ha comunicato i risultati finanziari del secondo trimestre 2025 e ha fornito importanti aggiornamenti sulla pipeline. La società ha chiuso il Q2 con $141,8 milioni di liquidità, sufficienti a sostenere le attività fino al 2027. La perdita netta è aumentata a $14,4 milioni rispetto a $5,4 milioni nello stesso periodo dell'anno precedente.
Tra gli sviluppi principali, è prevista l'estensione dello studio di Fase 3 HERO su ARD-101 per la sindrome di Prader‑Willi includendo pazienti di età inferiore ai 13 anni. Nuovi dati preclinici su ARD-201 hanno mostrato risultati promettenti nel prevenire il recupero di peso dopo l'interruzione degli agonisti del recettore GLP‑1 (GLP‑1RA), portando all'avvio di due nuovi studi di Fase 2, POWER e STRENGTH, in sostituzione del trial EMPOWER precedentemente pianificato.
La società ha inoltre rafforzato il proprio team dirigente con nomine strategiche nelle aree scientifica, commerciale, regolatoria e legale.
Aardvark Therapeutics (NASDAQ:AARD) presentó los resultados financieros del segundo trimestre de 2025 y ofreció actualizaciones relevantes sobre su pipeline. La compañía cerró el Q2 con $141,8 millones de dólares en efectivo, lo que respalda las operaciones hasta 2027. La pérdida neta aumentó a $14,4 millones desde $5,4 millones interanual.
Entre los avances clave figura la ampliación del ensayo de Fase 3 HERO con ARD-101 para el síndrome de Prader‑Willi para incluir a pacientes menores de 13 años. Nuevos datos preclínicos sobre ARD-201 mostraron resultados prometedores para prevenir la recuperación de peso tras la suspensión de los agonistas del receptor GLP‑1 (GLP‑1RA), lo que llevó al lanzamiento de dos nuevos ensayos de Fase 2, POWER y STRENGTH, que reemplazan al ensayo EMPOWER previamente planeado.
La compañía también reforzó su equipo directivo con nombramientos estratégicos en las áreas científica, comercial, regulatoria y legal.
Aardvark Therapeutics (NASDAQ:AARD)는 2025년 2분기 실적을 발표하고 파이프라인에 대한 주요 업데이트를 내놓았습니다. 회사는 2분기 말에 $141.8 million의 현금을 보유해 2027년까지 운영을 뒷받침할 것으로 보입니다. 순손실은 전년 동기 $5.4 million에서 $14.4 million으로 증가했습니다.
주요 내용으로는 프래더-윌리 증후군 치료제 ARD-101의 3상 HERO 시험을 13세 미만 환자까지 확대할 계획이 포함됩니다. ARD-201의 새로운 전임상 데이터는 GLP-1 수용체 작용제(GLP‑1RA) 중단 후 체중 반등을 예방하는 데 유망한 결과를 보여, 기존에 계획됐던 EMPOWER를 대체하는 두 건의 2상 시험(POWER 및 STRENGTH)을 진행하기로 했습니다.
또한 회사는 과학, 상업, 규제 및 법무 분야에서 전략적 임명을 통해 리더십을 강화했습니다.
Aardvark Therapeutics (NASDAQ:AARD) a publié ses résultats financiers du deuxième trimestre 2025 et fourni d'importantes mises à jour sur sa pipeline. La société disposait à la clôture du T2 de 141,8 millions de dollars de trésorerie, couvrant les opérations jusqu'en 2027. La perte nette est passée à 14,4 millions de dollars contre 5,4 millions un an plus tôt.
Parmi les évolutions clés, la société prévoit d'étendre l'essai de phase 3 HERO de ARD-101 pour le syndrome de Prader‑Willi afin d'inclure des patients de moins de 13 ans. De nouvelles données précliniques sur ARD-201 ont montré des résultats prometteurs pour prévenir la reprise de poids après l'arrêt des agonistes du récepteur GLP‑1 (GLP‑1RA), conduisant au lancement de deux nouveaux essais de phase 2, POWER et STRENGTH, en remplacement de l'essai EMPOWER précédemment prévu.
La société a par ailleurs renforcé son équipe de direction par des nominations stratégiques dans les fonctions scientifique, commerciale, réglementaire et juridique.
Aardvark Therapeutics (NASDAQ:AARD) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 und gab wichtige Updates zur Pipeline bekannt. Das Unternehmen verfügte Ende Q2 über $141,8 Millionen an Barmitteln, womit die Geschäftstätigkeit bis 2027 gestützt werden kann. Der Nettoverlust stieg auf $14,4 Millionen gegenüber $5,4 Millionen im Vorjahreszeitraum.
Zu den zentralen Entwicklungen gehört die geplante Ausweitung der Phase‑3‑Studie HERO zu ARD-101 bei Prader‑Willi‑Syndrom auf Patienten unter 13 Jahren. Neue präklinische Daten zu ARD-201 zeigten vielversprechende Ergebnisse zur Verhinderung eines Gewichtswiederanstiegs nach Absetzen von GLP‑1RA, woraufhin zwei neue Phase‑2‑Studien, POWER und STRENGTH, aufgelegt wurden, die die zuvor geplante EMPOWER‑Studie ersetzen.
Das Unternehmen stärkte zudem seine Führungsebene durch strategische Besetzungen in den Bereichen Wissenschaft, Vertrieb, Zulassung und Recht.
- Strong cash position of $141.8M supporting operations into 2027
- Expansion of ARD-101 Phase 3 trial to include younger PWS patients, potentially increasing market opportunity
- Promising preclinical data for ARD-201 showing weight rebound prevention after GLP-1RA discontinuation
- Strategic strengthening of leadership team with key appointments
- Net loss increased significantly to $14.4M from $5.4M year-over-year
- R&D expenses more than tripled to $13.1M from $4.0M year-over-year
- Phase 3 HERO trial topline data not expected until Q3 2026
Insights
Aardvark's strategic pipeline adjustments and strong cash position support extended runway despite widening losses as R&D investment intensifies.
Aardvark Therapeutics has made significant strategic adjustments to its clinical development programs based on compelling new preclinical data. The company is optimizing its obesity pipeline by splitting the ARD-201 program into two distinct Phase 2 trials: POWER, focusing on preventing weight rebound after GLP-1RA discontinuation, and STRENGTH, evaluating both monotherapy and combination therapy with GLP-1RAs for durable weight loss. This dual-path strategy intelligently positions ARD-201 as both a complementary therapy to GLP-1RAs and a potential standalone treatment.
For ARD-101 in Prader-Willi Syndrome (PWS), the planned expansion of the Phase 3 HERO trial to include pediatric patients under 13 years represents a strategic market expansion. This could substantially increase the addressable patient population at launch and potentially improve treatment outcomes through earlier intervention, which aligns with clinical observations that younger PWS patients may benefit more from early treatment.
Financially, the
The strategic leadership expansion with four key executive appointments (CSO, CCO, SVP Regulatory Affairs, and General Counsel) indicates preparation for potential commercialization and regulatory submission, signaling management's confidence in their clinical programs while building necessary infrastructure for future growth phases.
Aardvark's novel approach targeting hunger signaling pathways offers promising complementary strategy to GLP-1RAs for obesity management.
The preclinical data for ARD-201 offers a potentially significant clinical advancement in obesity treatment. Most notably, ARD-201's demonstrated ability to prevent weight regain after GLP-1RA discontinuation addresses one of the most challenging aspects of current obesity management – the substantial weight rebound that typically occurs when patients stop incretin therapy. By targeting hunger signaling pathways distinctly from GLP-1RAs, ARD-201 could serve as both a maintenance therapy for post-GLP-1RA treatment and potentially as a first-line option for patients who cannot tolerate or access GLP-1RAs.
The decision to split the clinical development into separate POWER and STRENGTH trials shows scientific sophistication. The POWER trial will specifically evaluate ARD-201's ability to maintain weight loss in patients who have already achieved approximately
For Prader-Willi Syndrome, expanding the ARD-101 HERO trial to include children under 13 reflects the understanding that hyperphagia in PWS manifests early in development. Early intervention could potentially modify disease trajectory and prevent complications associated with obesity in this population. The planned HONOR trial for acquired hypothalamic obesity – a condition with extremely limited treatment options – further demonstrates the company's commitment to addressing rare metabolic disorders with significant unmet needs.
The recruitment of Timothy Kieffer as CSO is particularly notable given his extensive expertise in metabolic research, suggesting the company is strengthening its scientific approach to metabolic pathway modulation.
- Compelling new ARD-201 preclinical data informs optimized Phase 2 clinical development strategy of obesity programs: Phase 2 POWER trial of oral ARD-201 to focus on weight rebound in patients discontinuing GLP-1RA therapy, while Phase 2 STRENGTH trial to focus on durable weight loss as a monotherapy and in combination with GLP-1RA.
- Anticipated expansion of Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS) to include pediatric population younger than 13 years of age.
$141.8 million in cash, cash equivalents, and short-term investments supports projected operations into 2027.
SAN DIEGO, Aug. 13, 2025 (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 second quarter ended June 30, 2025, and provided pipeline and business updates.
“Aardvark has made significant progress across our pipeline, and we are well-positioned to unlock the full potential of ARD-101 and ARD-201 across multiple studies in the year ahead," said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “Expansion of the Phase 3 HERO trial to include younger patients below the age of 13 would allow us to reach a larger segment of the PWS patient population through our registration label at launch and serve more patients in need. In addition, recent preclinical data from our ARD-201 obesity program strengthens our conviction in targeting hunger signaling pathways as a distinct and complementary approach to glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies, and we’re looking forward to further exploring the promising therapeutic profile of ARD-201 in the Phase 2 POWER and STRENGTH trials.”
Clinical Program Updates
ARD-101 for PWS
With the support from the PWS community, combined with historical data showing that younger patients are more likely to benefit from early intervention, Aardvark intends to expand the Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with PWS to include patients under the age of 13.
ARD-201 for Obesity
Preclinical data announced on August 12, 2025 demonstrated that investigational oral obesity therapy ARD-201 not only significantly reduced body weight, but also helped prevent weight regain (weight rebound) after discontinuation of GLP-1RA. Driven by these new preclinical insights, Aardvark is advancing ARD-201 in two Phase 2 trials, the POWER and STRENGTH trials, in place of the previously planned EMPOWER trial.
Updated Milestones
- Topline data from the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia associated with PWS is expected in the third quarter of 2026.
- Initiation of the Phase 2 POWER trial evaluating ARD-201’s potential to prevent weight regain in subjects who discontinue GLP-1RA therapy after achieving substantial prior weight loss (~
15% ) is expected in the second half of 2025. - Initiation of the Phase 2 STRENGTH trial evaluating placebo-adjusted weight loss and the additive effects of ARD-201 combined with GLP-1RA therapy is expected in the first half of 2026.
- Initiation of the Phase 2 HONOR trial evaluating ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025 with anticipated topline data readout in the second half of 2026.
Summary of Business Highlights
- In May 2025, Aardvark bolstered its leadership team with strategic hires across scientific, commercial, regulatory and legal functions with the appointments of Timothy Kieffer, Ph.D., as Chief Scientific Officer; Danny Villeneuve as Chief Commercial Officer; Terrie Kellmeyer, Ph.D., as Senior Vice President, Regulatory Affairs; and Christian Zapf, J.D., as General Counsel.
- In June 2025, Aardvark presented previously disclosed data from its Phase 2 trial of ARD-101 in PWS in a poster and a five-minute “lightning” oral presentation at the 2025 United in Hope Conference. In addition, Aardvark’s Chief Medical Officer, Manasi Jaiman, M.D., participated in a panel with clinicians to discuss the details of the company’s ongoing Phase 3 HERO trial.
Select Second Quarter 2025 Financial Highlights
- Cash Position: As of June 30, 2025, Aardvark had cash, cash equivalents, and short-term investments of
$141.8 million . Based on current operating plans, Aardvark believes that its existing cash, cash equivalents, and short-term investments will be sufficient to fund projected operations into 2027. - R&D Expenses: Research and development expenses were
$13.1 million and$4.0 million for the quarter ended June 30, 2025, and 2024, respectively. The$9.1 million increase for the quarter ended June 30, 2025, resulted from increased development costs primarily related to ARD-101 and an increase in personnel-related expenses. - G&A Expenses: General and administrative expenses were
$2.7 million and$2.0 million for the quarter ended June 30, 2025, and 2024, respectively. The$0.7 million increase for the quarter ended June 30, 2025, primarily resulted from increases in professional fees, facilities and other and personnel-related costs, which were partially related to commencing operations as a public company. - Net loss: Net loss was
$14.4 million and$5.4 million for the quarter ended June 30, 2025, and 2024, respectively, primarily due to increased research and development and general and administrative expenses.
About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of PWS and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of 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. ARD-101 is also being studied in hypothalamic obesity. Additionally, Aardvark is developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, and conducting two separate trials, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit aardvarktherapeutics.com.
Forward-Looking Statements
Statements 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 future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, anticipated cash runway, likelihood of success, as well as plans and objectives of management for future operations. Words including, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “promising,” “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 ARD-101, including the anticipated expansion of the Phase 3 HERO trial for the treatment of hyperphagia associated PWS to include pediatric population younger than 13 years of age and the expected timeline for receiving topline data from the Phase 3 HERO trial; ARD-201’s potential, including its potential as a monotherapy and in combination with GLP-1RA and its promising therapeutic profile; and the trial design for the POWER and STRENGTH trials and the expected timing for commencing such trials. 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, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and production of drug product for use in clinical and preclinical trials; 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 factors discussed in the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Carolyn.hawley@inizioevoke.com
Aardvark Therapeutics, Inc. Unaudited Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) | |||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 13,145 | $ | 4,029 | $ | 20,900 | $ | 5,236 | |||||||||
| General and administrative | 2,703 | 2,030 | 5,418 | 2,891 | |||||||||||||
| Credit loss—related party accounts receivable | — | 14 | — | 117 | |||||||||||||
| Total operating expenses | 15,848 | 6,073 | 26,318 | 8,244 | |||||||||||||
| Loss from operations | (15,848 | ) | (6,073 | ) | (26,318 | ) | (8,244 | ) | |||||||||
| Total other income (expense), net | 1,481 | 624 | 2,641 | 617 | |||||||||||||
| Net loss | $ | (14,367 | ) | $ | (5,449 | ) | $ | (23,677 | ) | $ | (7,627 | ) | |||||
| Net loss per share of common stock, basic and diluted | $ | (0.66 | ) | $ | (1.37 | ) | $ | (1.36 | ) | $ | (1.92 | ) | |||||
| Weighted-average shares used in net loss per share calculation | 21,690,275 | 3,967,984 | 17,465,965 | 3,967,658 | |||||||||||||
| Aardvark Therapeutics, Inc. Condensed Consolidated Balance Sheets (in thousands) | ||||||
| June 30, 2025 (unaudited) | December 31, 2024 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 25,998 | $ | 61,641 | ||
| Short-term investments | 115,822 | 12,022 | ||||
| Prepaid expenses and other current assets | 2,948 | 474 | ||||
| Total current assets | 144,768 | 74,137 | ||||
| Operating lease right-of-use asset | 522 | 735 | ||||
| Other assets | 2,185 | 2,635 | ||||
| Total assets | $ | 147,475 | $ | 77,507 | ||
| Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 5,056 | $ | 2,298 | ||
| Accrued liabilities | 4,837 | 2,291 | ||||
| Operating lease liability, current portion | 417 | 338 | ||||
| Total current liabilities | 10,310 | 4,927 | ||||
| Operating lease liability, net of current portion | 228 | 441 | ||||
| Other long-term liabilities | 12 | 26 | ||||
| Total liabilities | 10,550 | 5,394 | ||||
| Commitments and contingencies | ||||||
| Convertible preferred stock | — | 126,756 | ||||
| Stockholders’ equity (deficit): | ||||||
| Common stock | — | — | ||||
| Additional paid-in-capital | 218,932 | 3,684 | ||||
| Accumulated other comprehensive income | (3 | ) | — | |||
| Accumulated deficit | (82,004 | ) | (58,327 | ) | ||
| Total stockholders’ equity (deficit) | 136,925 | (54,643 | ) | |||
| Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) | $ | 147,475 | $ | 77,507 | ||
FAQ
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