Core Insights - Aardvark Therapeutics has paused its Phase 3 HERO and open-label extension trials for ARD-101 in Prader-Willi syndrome and the ARD-201 obesity program due to cardiac findings from a separate study [1][2][7] - The company plans to provide further guidance on these programs in the second quarter of 2026 [1] Group 1: Trial Updates - The pause in trials was prompted by cardiac findings from a healthy volunteer study, not from previous Prader-Willi syndrome trials [2] - In a cohort of eight participants dosed at 1,600 mg twice daily, two showed QRS increases greater than 25% from baseline, while another had a smaller increase [2] - A follow-on cohort dosed at 800 mg twice daily for up to one week had one of 23 participants with a transient QRS increase of less than 25%, and another with an increase greater than 25% [2] Group 2: Financial Position - Aardvark ended 2025 with $110.0 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the second quarter of 2027 [3] Group 3: Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing small-molecule therapies aimed at suppressing hunger in Prader-Willi syndrome and metabolic diseases [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AARDVARK THERAPEUTICS, INC. (Exact name of Registrant as specified in its Charter) | Delaware | 82-1606367 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | | 4370 La Jolla Village Drive, Suite 1050 | | | San Diego, CA | 92122 | | (Address of principal executive offices) | (Zip Code) | | Registrant's telephone number, including area code: (858) 225-7696 | | FO ...

Financial Performance - Aardvark Therapeutics reported a net loss of $17.6 million for Q4 2025, compared to a net loss of $8.8 million for Q4 2024, and a total net loss of $57.6 million for the year ended December 31, 2025, compared to $20.6 million for 2024[10]. - The company reported a total operating expense of $62.7 million for the year ended December 31, 2025, compared to $22.8 million for 2024[10]. - General and Administrative (G&A) expenses for Q4 2025 were $4.4 million, compared to $1.4 million in Q4 2024, with total G&A expenses for 2025 at $13.8 million versus $5.3 million in 2024[10]. - Research and Development (R&D) expenses for Q4 2025 were $14.3 million, an increase from $8.1 million in Q4 2024, with total R&D expenses for 2025 reaching $48.9 million compared to $17.4 million in 2024[10]. Cash and Assets - Cash, cash equivalents, and short-term investments totaled $110.0 million as of December 31, 2025, up from $73.7 million as of December 31, 2024, providing a runway into Q2 2027[10]. - Total current assets increased to $111,886 million in 2025 from $74,137 million in 2024, representing a growth of 50.9%[19]. - Cash and cash equivalents decreased to $47,051 million in 2025 from $61,641 million in 2024, a decline of 23.6%[19]. - Short-term investments surged to $62,976 million in 2025 from $12,022 million in 2024, a remarkable increase of 424.5%[19]. - Other assets increased to $4,940 million in 2025 from $2,635 million in 2024, a growth of 87.6%[19]. Liabilities and Equity - Total liabilities rose to $10,548 million in 2025 compared to $5,394 million in 2024, marking an increase of 95.5%[19]. - The accumulated deficit increased to $(115,918) million in 2025 from $(58,327) million in 2024, reflecting a worsening of 98.5%[19]. - Total stockholders' equity improved to $106,633 million in 2025 from $(54,643) million in 2024, indicating a significant recovery[19]. - Accounts payable decreased slightly to $2,072 million in 2025 from $2,298 million in 2024, a reduction of 9.8%[19]. - Accrued liabilities increased significantly to $8,035 million in 2025 from $2,291 million in 2024, an increase of 251.5%[19]. - Operating lease right-of-use asset decreased to $355 million in 2025 from $735 million in 2024, a decline of 51.7%[19]. Clinical Trials and Programs - Aardvark announced a voluntary pause in the Phase 3 HERO and OLE trials for ARD-101 due to unexpected cardiac observations, with further guidance expected in Q2 2026[1]. - The ARD-201 obesity program is also on voluntary pause, pending next steps with ARD-101, with further updates anticipated in Q2 2026[1]. - Aardvark is conducting a comprehensive review of data related to ARD-101 and is actively engaging with the FDA to determine next steps[4]. - Clinical data published in Molecular Metabolism showed ARD-101 significantly reduced self-reported hunger by 1.63 points compared to 0.65 points with placebo at Day 28 in a Phase 2 study[7]. - Aardvark's lead compound, ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS)[11].

Core Insights - Aardvark Therapeutics has voluntarily paused the Phase 3 HERO and OLE trials for ARD-101, aimed at treating hyperphagia in Prader-Willi Syndrome (PWS), due to unexpected cardiac observations in a separate trial [1][3] - The company has $110 million in cash and short-term investments as of December 31, 2025, which is expected to support operations into Q2 2027 [1][8] - Further guidance on the ARD-101 and ARD-201 programs is anticipated in Q2 2026 [1][4] Pipeline Updates - The voluntary pause in the ARD-101 trials follows the observation of reversible cardiac issues in a healthy volunteer trial, where two out of eight participants showed significant increases in QRS duration [3][4] - Aardvark is conducting a comprehensive review of the data and is in active discussions with the FDA regarding the next steps for the ARD-101 program [4][8] - The ARD-201 obesity program, which includes the POWER and STRENGTH trials, is also on voluntary pause pending further developments with ARD-101 [1][8] Clinical Data - Recent publications in Molecular Metabolism highlight that ARD-101 significantly reduced self-reported hunger in a Phase 2 obesity study, with a decrease of 1.63 points on the Control of Eating Questionnaire compared to 0.65 points for placebo [8] - The study also indicated that ARD-101 increased levels of gut hormones such as peptide YY (PYY) and glucagon-like peptide-1 (GLP-1), which are relevant to hunger regulation [8] Financial Highlights - Aardvark reported a net loss of $17.6 million for Q4 2025, compared to a net loss of $8.8 million in Q4 2024, and a total net loss of $57.6 million for the year ended December 31, 2025, compared to $20.6 million in 2024 [9][14] - Research and Development (R&D) expenses for Q4 2025 were $14.3 million, up from $8.1 million in Q4 2024, with total R&D expenses for the year reaching $48.9 million [8][14]

LOS ANGELES, March 11, 2026 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Aardvark Therapeutics, Inc., ("Aardvark" or the "Company") (NASDAQ:AARD) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors. Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: lesley@portnoylaw.com, to discuss their legal rights, or join the case via https://portnoylaw.com/aardvark-therapeutics-inc. Th ...

Core Viewpoint - The Schall Law Firm is investigating Aardvark Therapeutics, Inc. for potential violations of securities laws following a significant drop in share price due to safety concerns related to a late-stage trial pause [1][2]. Group 1: Investigation Details - The investigation focuses on whether Aardvark issued false or misleading statements or failed to disclose important information to investors [2]. - Aardvark paused its late-stage study for a rare disease treatment after discovering heart-related side effects during safety monitoring in a healthy volunteer study [2]. - Following the announcement of the trial pause, Aardvark's shares fell by over 47.3% in after-hours trading on the same day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who suffered losses are encouraged to contact the firm to discuss their rights free of charge [3].

Core Viewpoint - Aardvark Therapeutics Inc. has voluntarily paused its Phase 3 HERO trial for Prader-Willi Syndrome due to safety concerns, leading to a significant drop in stock price by almost 61% [1][2]. Group 1: Trial Update - The company will not release topline data from the HERO trial as previously expected in Q3 2026 due to reversible cardiac observations at higher than target therapeutic doses [2]. - The CEO emphasized the commitment to patient safety and the importance of evaluating the signals seen at elevated doses of ARD-101, while planning to collaborate closely with the FDA and the Prader-Willi Syndrome community [3]. Group 2: Stock Performance - The stock is trading 1.5% below its 20-day simple moving average (SMA) and 2.3% below its 100-day SMA, indicating a bearish trend [4]. - Shares have decreased approximately 73% over the past 12 months and are closer to their 52-week lows than highs [4]. - The RSI is at 50.00, indicating neutral territory, while the MACD is at -0.05, suggesting bearish pressure on the stock [5]. Group 3: Analyst Consensus - The stock carries a Buy Rating with an average price target of $21.89, although recent analyst actions have lowered targets [6]. - Key resistance is identified at $5.00 and key support at $4.50 [6].

Core Viewpoint - Aardvark Therapeutics, Inc. is under investigation for potential securities fraud and unlawful business practices following a significant stock price drop due to the voluntary pause of its Phase 3 HERO trial [1][3]. Group 1: Company Actions - On February 27, 2026, Aardvark announced the voluntary pause of the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial due to reversible cardiac observations at above target therapeutic doses found during routine safety monitoring [3]. - The company is conducting a comprehensive review of the data to inform next steps regarding the HERO trial [3]. Group 2: Market Reaction - Following the announcement of the trial pause, Aardvark's stock price fell by $7.02 per share, representing a 56.2% decrease, closing at $5.47 per share on March 2, 2026 [3]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of Aardvark investors regarding potential securities fraud or other unlawful business practices by the company and its officers and/or directors [1].

Core Viewpoint - Aardvark Therapeutics Inc. has voluntarily paused its Phase 3 HERO trial for Prader-Willi Syndrome due to safety concerns, specifically reversible cardiac observations at higher than target therapeutic doses [1][2]. Company Actions - The company is conducting a comprehensive review of safety data and will not announce topline data from the HERO trial as previously expected in Q3 2026 [2]. - Aardvark's CEO, Tien Lee, emphasized the commitment to patient safety and the importance of evaluating the signals seen at elevated doses of ARD-101, while planning to collaborate closely with the FDA and the Prader-Willi Syndrome community [3]. Analyst Perspectives - Analysts find it challenging to assess the prospects of ARD-101 in Prader-Willi syndrome due to limited information, with concerns that the study pause may prevent the Phase 3 HERO trial from being fully completed [4]. - Analyst Andy T. Hsieh noted that unblinding the study early could provide sufficient sample size for investors to evaluate the risk/benefit profile of ARD-101, as over half of the target of 90 patients had been completed by mid-January [5][6]. - Assuming resolution of the cardiac safety event, Aardvark may be able to accelerate and streamline the second pivotal study with increased confidence in its statistical assumptions [6]. Stock Performance - Aardvark Therapeutics shares fell 55.88% to $5.51 during premarket trading, nearing its 52-week low of $4.88 [6]. - Recent analyst downgrades include RBC Capital to Sector Perform with a target of $6.00, Stifel to Hold with a target of $6.00, Morgan Stanley to Equal-Weight with a target of $7, and HC Wainwright to Neutral [7].

Market Overview - U.S. stock futures fell sharply on Monday following Friday's losses, influenced by the ongoing Iran-U.S. conflict and the death of Iranian Supreme Leader Ayatollah Ali Khamenei [1] - The Dow Jones, S&P 500, Nasdaq 100, and Russell 2000 indices experienced declines of -1.15%, -1.12%, -1.51%, and -1.36% respectively [3] Company Performance - AMTD Digital Inc. (NYSE:HKD) surged 20% in premarket trading after reporting a year-over-year increase in FY25 revenue [4] - Aardvark Therapeutics Inc. (NASDAQ:AARD) plunged 53.56% after pausing its Phase 3 trial, maintaining a weak price trend in the short and medium terms [4] - Avalon Globocare Corp. (NASDAQ:ALBT) tumbled 22.82% due to a private placement announcement, with a strong short-term price trend but weaker medium and long-term trends [4] - LI Bang International Corporation Inc. (NASDAQ:LBGJ) declined 24.85% after announcing an acquisition, showing a strong short and medium-term price trend but a weak long-term trend [4] - MongoDB Inc. (NASDAQ:MDB) dropped 2.27% as analysts expect earnings of $1.45 per share on revenue of $667.15 million [11] Economic Insights - Mohamed El-Erian warns of a "new stagflationary wind" affecting the global economy, driven by geopolitical shocks and persistent inflation [6] - The U.S. stock market is expected to experience volatility, dispersion, and fragmentation, with logistical friction from rising insurance premiums and maritime rerouting [7] - The market may face widening gaps between "winners and losers" as energy costs rise and growth encounters headwinds [8] Commodities and Global Markets - Crude oil futures rose by 7.71% to approximately $72.19 per barrel, while gold prices increased by 2.22% to around $5,395.00 per ounce [10] - The U.S. Dollar Index spot was up 0.66% at 98.2480, while Bitcoin traded 0.10% lower at $66,306.44 [10] Asian and European Markets - Asian markets closed mixed, with China's CSI 300 and Australia's ASX 200 rising, while Japan's Nikkei 225 and other indices fell [11]