Financial Performance - Aardvark Therapeutics raised $97.9 million in gross proceeds from its IPO, with net proceeds of approximately $87.5 million[3]. - The net loss for Q1 2025 was $9.3 million, compared to a net loss of $2.2 million in Q1 2024[7]. - Total operating expenses for Q1 2025 were $10.5 million, significantly higher than $2.2 million in Q1 2024[11]. - The weighted-average shares used in the net loss per share calculation for Q1 2025 were approximately 13.2 million[11]. Cash and Investments - As of March 31, 2025, Aardvark had cash, cash equivalents, and short-term investments totaling $151.3 million, sufficient to fund operations into 2027[6]. - Total assets as of March 31, 2025, were $157.0 million, up from $77.5 million at the end of 2024[13]. Research and Development - Research and development expenses increased to $7.8 million for Q1 2025, up from $1.2 million in Q1 2024, reflecting a $6.6 million increase[6]. - Aardvark's lead candidate, ARD-101, is in Phase 3 clinical development for treating hyperphagia associated with Prader-Willi Syndrome, with data readout expected in early 2026[5]. - Aardvark is also developing ARD-201, a fixed-dose combination aimed at addressing limitations of current GLP-1 therapies for obesity[8]. General and Administrative Expenses - General and administrative expenses rose to $2.7 million in Q1 2025, compared to $0.9 million in Q1 2024, marking a $1.9 million increase[6].

Core Viewpoint - Aardvark Therapeutics is focused on developing innovative small-molecule therapeutics aimed at activating innate homeostatic pathways to treat metabolic diseases, with a particular emphasis on addressing hunger signaling in rare metabolic diseases and obesity [2][5]. Business Highlights - Aardvark completed its initial public offering (IPO) in February 2025, raising $97.9 million in gross proceeds, resulting in approximately $87.5 million in net proceeds after expenses [3]. - The company's stock began trading under the symbol "AARD" on February 13, 2025 [3]. Financial Highlights - As of March 31, 2025, Aardvark reported cash, cash equivalents, and short-term investments totaling $151.3 million, which is expected to support operations into 2027 [6][7]. - Research and development expenses for the first quarter of 2025 were $7.8 million, a significant increase from $1.2 million in the same quarter of 2024, primarily due to higher development costs related to ARD-101 [7]. - General and administrative expenses rose to $2.7 million in the first quarter of 2025 from $0.9 million in the same quarter of 2024, attributed to increased professional fees and costs associated with being a public company [7]. - The net loss for the first quarter of 2025 was $9.3 million, compared to a net loss of $2.2 million in the first quarter of 2024 [7][10]. Clinical Development - Aardvark's lead candidate, ARD-101, is in Phase 3 clinical development for treating hyperphagia associated with Prader-Willi Syndrome (PWS), with data readout expected in early 2026 [6][2]. - The company is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, aimed at addressing limitations of existing GLP-1 therapies for obesity [5].

Core Viewpoint - Aardvark Therapeutics, Inc. is actively engaging in presenting its clinical developments and strategies at various conferences in May 2025, highlighting its focus on novel therapeutics for metabolic diseases [1][4]. Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company that develops small-molecule therapeutics aimed at suppressing hunger, particularly for conditions like Prader-Willi Syndrome (PWS) and other metabolic diseases [2]. - The lead compound, ARD-101, is currently in Phase 3 clinical development for treating hyperphagia associated with PWS and is also being studied for hypothalamic obesity [2]. - Aardvark is developing ARD-201, a combination of ARD-101 and a DPP-4 inhibitor, to address limitations of existing GLP-1 therapies for obesity and related conditions [2]. Upcoming Presentations - Aardvark will present at the following conferences: - Bank of America Global Healthcare Conference on May 15, 2025, at 12:35 p.m. ET [4]. - H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 3:30 p.m. ET [4]. - RBC Capital Markets Global Healthcare Conference on May 21, 2025, at 2:35 p.m. ET [4]. - Live webcasts of these presentations will be available on the company's website, with archived recordings accessible for approximately one month post-presentation [1].

Clinical Trials and Product Development - The company has initiated a Phase 3 clinical trial for its lead product candidate, ARD-101, targeting hyperphagia associated with Prader-Willi Syndrome (PWS), with topline data expected in early 2026[16]. - In a completed Phase 2 clinical trial for ARD-101 in subjects with PWS, 12 subjects showed an average decline of approximately 8 points in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score after 28 days[18]. - The company plans to conduct a Phase 2 clinical trial for hyperphagia associated with hypothalamic obesity (HO), referred to as the HONOR trial, expected to initiate in the second half of 2025[19]. - ARD-201, a fixed-dose combination of ARD-101 and a DPP-4 inhibitor, is being developed to address obesity and obesity-related conditions, with a Phase 2 EMPOWER trial planned for the second half of 2025[20]. - The Phase 2 clinical trial of ARD-101 demonstrated well-tolerated results with limited systemic absorption, reducing potential systemic toxicity[18]. - The Phase 3 HERO trial for ARD-101 in subjects with hyperphagia associated with PWS was initiated in December 2024, with results expected in early 2026[61]. - The Phase 3 HERO trial for ARD-101 is designed to treat subjects with PWS-associated hyperphagia over 12 weeks, with topline data expected in early 2026[101]. - The company plans to conduct the Phase 3 trial in multiple countries, including the United States, the United Kingdom, and South Korea[101]. - The company plans to initiate the Phase 2 clinical trial for ARD-101 in hyperphagia associated with hypothalamic obesity (HO) in the second half of 2025, with topline data expected in the first half of 2026[111]. - In Phase 2a clinical trials, ARD-101 demonstrated a 2.51-fold greater reduction in hunger rating compared to placebo, with a statistically significant p-value of 0.015[136]. - The company has completed Phase 2a clinical trials of ARD-101, which showed no dose-limiting safety issues or serious adverse events (SAEs)[113]. - The second part of the Phase 2 trial involved dose escalation from 400 mg to 800 mg BID, with all patients experiencing benefits and mild adverse events[90]. Financials and Funding - The company raised $129.1 million prior to its IPO in February 2025, including $85.0 million from a Series C financing in May 2024, and net proceeds from the IPO were approximately $87.5 million[25]. - The estimated cost of obesity-related healthcare in the U.S. was $261 billion in 2016, emphasizing the financial burden of obesity on the healthcare system[116]. - The global market for branded anti-obesity drugs is projected to reach over $100 billion by 2030, driven by an estimated increase in global obesity prevalence to over 50% by 2035[116]. Regulatory and Compliance - The company must submit annual progress reports and safety reports to the FDA, detailing any serious adverse reactions or significant risks identified during trials[177]. - The regulatory process for drug candidates requires substantial time and financial resources, with potential delays due to non-compliance leading to administrative or judicial sanctions[170]. - The FDA's review process for New Drug Applications (NDAs) aims for a standard review within 10 months and priority review within 6 months, depending on the product's significance[183]. - The FDA requires satisfactory completion of pre-approval inspections of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP)[173]. - The company is subject to numerous regulatory authorities in the U.S., including the FDA and CMS, impacting manufacturing, sales, and marketing activities[200]. - Non-compliance with regulatory requirements can lead to severe consequences, including criminal prosecution, fines, and product recalls[202]. - The FDA allows for 505(b)(2) NDAs, enabling applicants to use existing studies not conducted by them, which can expedite the approval process[204]. - The FDA's fast track designation program aims to expedite the review of drugs intended for serious conditions, with a determination made within 60 days of the request[191]. - Priority review can shorten the review timeframe to six months for products that significantly improve safety and effectiveness compared to existing therapies[192]. - Accelerated approval may be granted for products that show meaningful advantages over existing therapies, but requires post-approval confirmatory studies[193]. - Post-approval, manufacturers must comply with ongoing FDA regulations, including monitoring adverse experiences and maintaining cGMP compliance[198]. Product Characteristics and Market Need - ARD-101 is an oral gut-restricted small-molecule that is approximately 99% restricted to the gut with minimal systemic exposure, leading to local elevation of gut peptide hormones like CCK and GLP-1[33]. - The hypothalamic obesity condition affects approximately 5,000-10,000 people in the United States, highlighting the unmet need for effective treatments[19]. - The incidence of Prader-Willi Syndrome (PWS) is approximately 1 in 15,000 births globally, with an estimated 10,000 to 20,000 patients in the U.S.[51]. - ARD-101 aims to address the limitations of current GLP-1 therapies by stimulating local secretion of CCK to reduce hunger without significant side effects[42]. - ARD-101 has shown potential in preclinical studies to decrease food intake and body weight without treatment tachyphylaxis, indicating sustained efficacy[62]. - The treatment with ARD-101 led to a mean placebo-adjusted weight loss of approximately -1% at 28 days without chronic nausea, a common issue with GLP-1 receptor agonists[136]. - The company aims to leverage its expertise in TAS2R targeting to expand its pipeline across metabolic, inflammatory, and other adjacent indications[26]. Competition and Market Strategy - The company faces competition from major pharmaceutical companies and biotechnology firms in the obesity treatment market, including Eli Lilly and Novo Nordisk[154]. - The commercial strategy for product candidates is still under evaluation, with potential use of strategic partners or establishing a commercial sales force[159]. - The company plans to selectively evaluate strategic collaborations to enhance the development and commercialization of its product candidates[26]. Intellectual Property - The patent portfolio includes 22 distinct patent application families, with 17 issued U.S. patents and 72 pending applications as of March 12, 2025[161]. - ARD-101 has received orphan drug designation for the treatment of Prader-Willi Syndrome (PWS), which could provide seven years of marketing exclusivity upon approval[162].

Financial Performance - Aardvark Therapeutics reported a net loss of $20.6 million for the year ended December 31, 2024, compared to a net loss of $7.2 million in 2023, representing an increase of 186%[10] - Research and development expenses increased to $17.4 million in 2024 from $4.5 million in 2023, marking a rise of 184%[10] - General and administrative expenses rose to $5.3 million in 2024, up from $2.2 million in 2023, reflecting an increase of 141%[10] - Cash, cash equivalents, and short-term investments totaled $73.7 million as of December 31, 2024, excluding IPO proceeds[10] - As of December 31, 2024, total assets were reported at $77.5 million, a significant increase from $10.5 million in 2023[15] Clinical Trials and Development - The lead candidate ARD-101 showed a meaningful reduction in hyperphagia of up to 16 points in a Phase 2 trial for Prader-Willi Syndrome, with an average reduction of approximately 8 points among compliant subjects[5] - The ongoing Phase 3 HERO trial for ARD-101 is expected to generate topline data in early 2026[6] - Aardvark plans to initiate the Phase 2 HONOR trial for ARD-101 in the second half of 2025, targeting hyperphagia associated with acquired hypothalamic obesity[10] - The company is also set to begin the Phase 2 EMPOWER trial for ARD-201 in the second half of 2025, focusing on obesity and obesity-related conditions[10] IPO and Funding - Aardvark completed its IPO in February 2025, raising $97.9 million in gross proceeds to support ongoing and future pipeline development[6]

Table of Contents As filed with the Securities and Exchange Commission on February 6, 2025 Registration No. 333-284440 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act Of 1933 AARDVARK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 82-1606367 (Primary Standard Industrial Classification Code Number) (I.R.S. E ...

Table of Contents As filed with the Securities and Exchange Commission on January 23, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT Under The Securities Act Of 1933 AARDVARK THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 (858) 225-7696 (Address, including zip code, and telepho ...