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Aardvark Therapeutics, Inc.

For the period ended Mar 31, 2026. Filed May 7, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 7, 2026

AARD$1.17+5.4%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-13.

0001193125-25-280260

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001193125-26-210675

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 184 previous paragraphs and 161 current paragraphs.

119 unchanged; 31 reworded; 11 added; 29 removed; 5 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (11)

Current report

TAS2Rs are a family of 26 different nutrient-sensing G protein-coupled receptors (GPCRs) that are broadly expressed among vertebrates. TAS2Rs are present in the oral cavity to convey bitter taste and are highly expressed in many other tissues throughout the body where they are key in regulating metabolic and inflammatory pathways. CCK has long been recognized as a promising pharmaceutical target because its release is triggered with food and it helps suppress hunger, which is the feeling of discomfort that comes from a perception of not having eaten recently. We believe suppression of hunger could be complementary to the suppression of appetite reported from patients on GLP-1 receptor targeted treatments, which reduce the desirability of food. Previous approaches to directly agonize CCK receptors through exogenous molecules have been limited by safety concerns driven by systemic exposure, resulting in on-target activity in undesired tissues and have been associated with pancreatic safety concerns, including pancreatitis. Our wholly-owned lead product candidate, ARD-101, is an oral, largely gut-restricted small-molecule agonist of certain TAS2Rs expressed on luminally accessible enteroendocrine cells lining the gut. ARD-101, in contrast to previous approaches to directly agonize CCK receptors, elicits the endogenous release of CCK by leveraging the body’s natural response to TAS2R agonism. To our knowledge, besides our product candidates, there are no approved therapies and no other clinical-stage candidates that directly target TAS2Rs.

Current report

ARD-101 has limited systemic absorption, which we believe reduces the potential for systemic toxicity and has contributed to ARD-101 being well-tolerated in our Phase 1 and 2 trials. We have completed a Phase 1 clinical trial of ARD-101 in healthy volunteers and a Phase 2 clinical trial in subjects with hyperphagia associated with Prader-Willi Syndrome (PWS). The Phase 2 clinical trial in hyperphagia associated with PWS evaluated two dosing regimens over 28 days followed by a 14-day withdrawal period. In Part 1 of the trial, 12 subjects completed the treatment period at a fixed dose of 200 mg delivered orally twice daily (BID). These 12 subjects that completed treatment had no significant treatment-related adverse events and, of these subjects, eight completed the Hyperphagia for Clinical Trial Questionnaire-9 (HQ-CT 9), with seven having complete post–database lock datasets. In this subgroup of seven, the mean decline at day 28 was approximately 9 points. In Part 2 of the trial, four subjects were dosed under a revised protocol: 400 mg BID for seven days, followed by 600 mg BID for seven days and ending with 800 mg BID for 14 days. The four subjects that completed the trial per protocol had only grade 1 treatment-related adverse events and showed a decrease in HQ-CT 9 of approximately eight points at 28 days. Thus, in our completed Phase 2 clinical trial in subjects with hyperphagia associated with PWS, ARD-101 was shown to be well-tolerated and demonstrated clinical activity through a reduction in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scores.

Current report

On February 27, 2026, we voluntarily paused enrollment and dosing in the HERO and OLE trials following reversible cardiac observations in a healthy volunteer study and are currently reviewing the data and collaborating with the FDA to determine next steps. As a result, aspects of the trial design, development timeline and future clinical plans may change. Following the voluntary pause, we are reviewing the trial designs and protocols in collaboration with the FDA and the previously agreed protocol elements may be revisited.

Current report

Our second TAS2R program, ARD-201, was planned to be a fixed-dose combination of ARD-101 and a dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of obesity and obesity-related conditions, including the prevention of weight regain following treatment with GLP-1 receptor agonists, which we believe may address an important unmet need in the long-term management of obesity. We previously initiated a Phase 2 clinical trial, which we referred to as the POWER (Prevention Of WEight Regain) trial, in December 2025, to explore the efficacy of ARD-201 in the prevention of weight regain among patients who have successfully lost over 15% of body weight on GLP-1RA therapy. In addition, we previously planned to initiate a second Phase 2 trial for ARD-201 in the first half of 2026, which we referred to as the STRENGTH (Sitagliptin and TAS2R for weight Reduction with Exercise, Nutrition, and GLP-1RAT rial and Hunger assessment) trial. Because ARD-201 contains ARD-101 as a component of the planned combination therapy, we are assessing the potential implications of the voluntary pause of the HERO trial on the ARD-201 program, including the potential impact of the safety observations identified in the healthy volunteer study in the ARD-101 program on the development of ARD-201. Following this assessment, we have voluntarily paused the STRENGTH and POWER clinical trials, in addition to the HERO and OLE trials (collectively, the “voluntarily paused clinical programs”), while we complete our ongoing evaluation of the safety observations identified in the healthy volunteer study of ARD-101 and continue discussions with the FDA regarding next steps for the ARD-101 program. We expect to provide further guidance in the second quarter of 2026.

Current report

In preparation for these trials, we expanded our clinical management and regulatory capabilities, including hiring clinical, regulatory, CMC and quality personnel, and we expect to continue to need to expand our clinical management and regulatory capabilities and to rely on third parties to conduct our later stage or pivotal clinical trials in the future. However, the timing of additional staffing and operational expansion may be delayed as we evaluate next steps following the voluntary pause of our clinical programs, although we expect to continue to build our capabilities over time as our clinical programs progress, subject to the outcome of our ongoing review and discussions with the FDA.

Current report

continue our development of ARD-101 and evaluate next steps following the voluntary pause of our clinical programs;

Current report

hire additional personnel as our clinical programs advance and as we determine next steps following the voluntary pause of our clinical programs;

Current report

We currently have an effective shelf Registration Statement on Form S-3 (File No. 333-294537) that became effective on April 3, 2026, which allows us to undertake various equity and debt offerings up to $400.0 million. In addition, on March 23, 2026, we entered into an Equity Distribution Agreement with Piper Sandler & Co. (the Agent), pursuant to which we may offer and sell from time to time through the Agent up to $150.0 million in shares of our common stock (the ATM Facility). We are not obligated to sell any shares under the Equity Distribution Agreement, and the Agent is not obligated to buy or sell any shares of our common stock. We cannot provide any assurance that we will sell any shares under the Equity Distribution Agreement, or, if we do, as to the prices, amounts, or timing of any such sales. As of March 31, 2026, we have not sold any shares of common stock under the ATM Facility.
Removed paragraphs (29)

Previous report

We have delayed indefinitely our plans to evaluate ARD-101 in a Phase 2 clinical trial for hyperphagia associated with hypothalamic obesity (HO), which was referenced as the HONOR (Hypothalamic Obesity Neutralized On TAS2 R) trial. This will allow us to direct more resources to focus on the application of ARD-201.

Previous report

ARD-201 is planned to be a fixed-dose combination of the active ingredient in ARD-101 and a dipeptidyl peptidase-4 (DPP-4) inhibitor. Currently, both drugs are administered separately, but for ease of nomenclature, the combination treatment is referred to as ARD-201 throughout this document as it represents the intended final formulation. We previously planned to initiate a Phase 2 clinical trial referenced as the EMPOWER (Exploratory Multi-arm Preventionof WEight Regain) trial to explore the magnitude of ARD-201’s effect on a variety of parameters related to obesity and obesity-related conditions. Driven by new preclinical data, we now intend to substitute the EMPOWER trial with two separate trials to explore specific potential applications of ARD-201. The first of these trials is expected to be a Phase 2 clinical trial and is referenced as POWER (Prevention Of WEight Regain), which will primarily focus on the potential effect of ARD-201 (a co-administered combination of ARD-101 and a dipeptidyl peptidase-4 (DPP-4) inhibitor) on the prevention of the commonly observed weight regain of subjects that discontinue use of GLP-1 receptor agonist (GLP-1RA) treatment after having previously achieved substantial weight loss (approximately 15%) while on GLP-1RA treatment. We estimate treatment duration to be 24 weeks, with a 12-week interim analysis. Secondary endpoints will include body composition with a focus on lean body mass preservation or recovery as well as many additional exploratory endpoints. We expect to initiate the POWER trial within a similar time period as previously envisioned for the EMPOWER trial, which is in the second half of 2025 with anticipated preliminary or interim data available in the second half of 2026. We believe that the design of the POWER trial will allow for more focused data generation to elucidate the potential of ARD-201 for preventing weight regain after GLP-1RA discontinuation.

Previous report

The additional trial focusing on ARD-201 will be the STRENGTH (Sitagliptin and TAS2R for weight Reduction with Exercise, Nutrition, and GLP-1RAT rial and Hunger assessment) trial. This trial, which we expect will be a Phase 2 clinical trial, will explore the remaining key questions that were intended with the previously communicated EMPOWER trial that are not already being addressed with the POWER trial. Specifically, STRENGTH trial endpoints will include placebo adjusted weight loss and the potential additive effect of ARD-201 given in combination with GLP-1RA therapy. Secondary endpoints will include evaluating differences in absolute weight loss as well as relative quality of weight loss in terms of proportionality of lean muscle versus fat loss with each arm. We believe that the POWER and STRENGTH trials will enhance the probability of detecting potential clinical benefit with better clarity and precision than the trial design for the previously contemplated EMPOWER trial. We plan to initiate the STRENGTH trial in the first half of 2026.

Previous report

Recently obtained preclinical data demonstrate the synergy between ARD-101 and a DPP-4 inhibitor when used in combination (ARD-201). In a conventional high-fat diet (HFD) mouse model of diet-induced obesity (DIO mice), ARD-201 induced significant weight loss amounting to -18.8% ± 2.1% at 30 days of treatment, even while the mice remained on HFD (see figure below).

Previous report

(A)Body weight changes in DIO mice treated with ARD-201, sitagliptin diet, or vehicle. Body weight trajectories following once-daily oral administration of vehicle (water + saline), 6 g/kg sitagliptin chow diet or ARD-201 (75 mg/kg ARD-101 and sitagliptin chow diet). Data are presented as means (dot symbols) ± standard error of the mean (SEM) (bars) for each treatment group.

Previous report

(B) Percent change in body weight in (Day 30 relative to Day 0). Data are presented as means (bars) and SEM (error bars), with individual values overlaid (dots). Mice were maintained on high-fat diet throughout the study. N = 9 for vehicle and ARD-201 groups. N = 7 for sitagliptin diet group.

Previous report

In the same preclinical study, glucose homeostasis, as indicated by glucose curves and the area under the curve (AUC) from an Intraperitoneal Glucose Tolerance Test (IPGTT), was improved on Day 14 in the ARD-201 group compared to the negative (vehicle) control.

Previous report

(A)Glucose curves from mice treated with ARD-201, sitagliptin diet, or vehicle from IPGTT at Day 14. Glucose curves over a 90-minute interval of vehicle (water + saline), 6 g/kg sitagliptin chow diet, or ARD-201 (75 mg/kg ARD-101 and sitagliptin chow diet). Data are presented as means (dot symbols) ± SEM (bars) for each treatment group. N = 9 for vehicle and ARD-201 groups. N = 7 for sitagliptin diet group. N = 10 for baseline group.

Previous report

(B) AUC from IPGTT at Day 14. Data are presented as means (bars) and SEM (error bars), with individual values overlaid (dots). Mice were maintained on high-fat diet throughout the study. N = 9 for vehicle and ARD-201 groups. N = 7 for sitagliptin diet group. ***P < 0.001 for AUC 0-90minvs. the vehicle group.

Previous report

Additional data suggest that ARD-201 may curtail weight regain experienced after discontinuation of GLP-1RA agents. In DIO mice that were transiently treated with tirzepatide (used as a representative of the GLP-1RA class of agents), ARD-201 as a monotherapy showed improved weight maintenance compared to the negative (vehicle) control and demonstrated similar weight maintenance compared to continued treatment with high-dose tirzepatide (see figure below). Moreover, the combination of ARD-201 and the low dose of tirzepatide that was modestly effective on its own showed continued weight loss compared to high-dose tirzepatide. Details of the study have been submitted for peer review publication.

Previous report

(A)Body weight trajectories over two parts. In Part 1, mice were given a high dose of tirzepatide (10 nmol/kg body weight) once daily for two weeks. In Part 2, mice were dosed once daily with either vehicle (water + saline), low-dose tirzepatide (1 nmol/kg body weight), high-dose tirzepatide (10 nmol/kg body weight), ARD-201 (ARD-101, 75 mg/kg body weight and sitagliptin chow, 6 g/kg diet), or ARD-201-tirzepatide combo for two and a half weeks. Data are presented as means (dot symbols) ± SEM (error bars) for each treatment group. N = 40 in Part 1; N = 8 per group in Part 2, randomized from Part 1 according to body weight.

Previous report

(B)Percent change in body weight in Part 2 (Day 15 to end of study). Mice were maintained on high-fat diet throughout the study. Data are presented as means (bars) and SEM (error bars), with individual values overlaid (dots). Weight maintenance with ARD-201 and the high-dose tirzepatide group was comparable (no statistical difference detected), but weight loss preservation with the ARD-201-tirzepatide combo was substantially greater than with 10 nmol/kg tirzepatide alone (** P < 0.01).

Previous report

In the same preclinical study on Day 37, data suggest that ARD-201, as monotherapy and in combo, showed significant improvement in glucose tolerance compared to the negative (vehicle) control. The combination of ARD-201 and low-dose tirzepatide achieved the most rapid glucose clearance.

Previous report

(A)Glucose curves from mice treated once daily with either vehicle (water + saline), low-dose tirzepatide (1 nmol/kg body weight), high-dose tirzepatide (10 nmol/kg body weight), ARD-201 (ARD-101, 75 mg/kg body weight and sitagliptin chow, 6 g/kg diet), or ARD-201-tirzepatide combo, over a 90-minute period. Data are presented as means (dot symbols) ± SEM (bars) for each treatment group.

Previous report

(B) AUC from IPGTT. Data are presented as means (bars) and SEM (error bars), with individual values overlaid (dots). N = 8 per group. ***P< 0.001 for AUC 0-90min vs. the vehicle group.

Previous report

At termination of the preclinical study, high-dose tirzepatide, ARD-201 monotherapy, and ARD-201 combined with low-dose tirzepatide showed significant reductions in fat mass via DEXA scan compared to vehicle. High-dose tirzepatide and the ARD-201 combo reduced lean body mass compared with vehicle, whereas ARD-201 alone showed no significant reduction in lean mass.

Previous report

(A)Fat and lean body mass measured at termination, in grams. DEXA values of vehicle (water + saline), low-dose tirzepatide (1 nmol/kg body weight), high-dose tirzepatide (10 nmol/kg body weight), ARD-201 (ARD-101, 75 mg/kg body weight and sitagliptin chow, 6 g/kg diet), or ARD-201-tirzepatide combo. Data are presented as means (bars) and SEM (error bars), with individual values overlaid (dots). N = 8 per group. *P< 0.05, **P < 0.01, and ***P < 0.001 vs the vehicle group.

Previous report

continue our development of, seek regulatory approval for, and potentially commercialize ARD-101 and our other product candidates;

Previous report

incur additional costs associated with being a public company.

Previous report

Credit Loss – Accounts Receivable and Related Party Convertible Promissory Note

Previous report

In connection with a Transition Services Agreement (the Transition Services Agreement) entered into with Aardwolf Therapeutics, Inc. (Aardwolf), which was effective through May 31, 2024, we performed certain services and billed Aardwolf monthly. As Aardwolf currently does not have the ability to repay the related party receivables, these amounts are deemed uncollectible and have been written off until such time as Aardwolf has the ability to repay. In addition, in August 2022, we loaned Aardwolf $1.0 million in the form of a convertible promissory note, which, based on its current inability to repay, we also have written off as uncollectible. We will reassess the estimated recovery on previous written off balances at each reporting period.

Previous report

Comparison of the Nine Months ended September 30, 2025 and 2024

Previous report

R&D expenses were $34.6 million and $9.3 million for the nine months ended September 30, 2025 and 2024, respectively. The $25.3 million increase for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 resulted primarily from an increase of $19.9 million for external expenses incurred for clinical studies and CMC primarily related to the development of ARD-101 and a $5.0 million increase in personnel-related costs due to increased headcount.

Previous report

Amounts written off as uncollectible related to the Transition Services Agreement with Aardwolf were zero and $0.1 million for the nine months ended September 30, 2025 and 2024, respectively. The $0.1 million decrease for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 was due to the expiration of the Transition Services Agreement in May 2024.

Previous report

Other income, net was $4.0 million and $1.5 million for the nine months ended September 30, 2025 and 2024, respectively. The $2.5 million increase for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 resulted primarily from higher interest income generated by our higher invested cash balances.
Reworded paragraphs (31)

Previous wording

the initiation, timing, progress and results of our preclinical studies, clinical trials and research and development programs for our product candidates;

Current wording

the initiation, timing, progress, status and results of our preclinical studies, clinical trials and research and development programs for our product candidates, and our anticipated timeline for providing further guidance on, or results of, our preclinical studies and clinical trials;

Current wording

our ability to successfully restart or complete our clinical trials;

Previous wording

our plans relating to the further development and manufacturing of our product candidates, including additional indications for which we may pursue;

Current wording

our plans relating to the further development and manufacturing of our product candidates, including additional indications that we may pursue;

Previous wording

our anticipated use of our cash, cash equivalents and short-term investments resources, including the proceeds from our initial public offering (IPO), estimates of our expenses, capital requirements and needs for additional financing.

Current wording

our anticipated use of our cash, cash equivalents and short-term investments resources, estimates of our expenses, capital requirements and needs for additional financing.

Previous wording

Throughout this Quarterly Report, unless the context otherwise requires, the terms “Aardvark,” “we,” “us” and “our” in this Quarterly Report refer to Aardvark Therapeutics, Inc. and its subsidiary.

Current wording

Throughout this Quarterly Report, unless the context otherwise requires, the terms “Aardvark,” “we,” “us” and “our” in this Quarterly Report refer to Aardvark Therapeutics, Inc. and its subsidiaries.

Previous wording

We are a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases. We target biological pathways associated with alleviating hunger that we believe have the potential to deliver transformative outcomes for patients. We have focused our efforts on developing selective compounds, targeting Bitter Taste Receptors (TAS2Rs) for hunger-associated conditions. Our initial compounds target TAS2Rs expressed in the gut lumen, which normally respond to the nutrients in food and participate in the gut-brain axis. Our research has shown that activating these receptors can induce secretion of endogenous signaling molecules, including cholecystokinin (CCK) and glucagon-like peptide-1 (GLP-1).

Current wording

We are a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases. We target biological pathways associated with alleviating hunger that we believe have the potential to deliver transformative outcomes for patients. We have focused our efforts on developing selective compounds, targeting Bitter Taste Receptors (TAS2Rs) for hunger-associated conditions. Our initial compounds target TAS2Rs at the luminal surface of the gut epithelium, which normally respond to the chemicals in food and participate in the gut-brain axis. Our research has shown that activating these receptors can induce the secretion of endogenous signaling molecules, including cholecystokinin (CCK), peptide YY (PYY) and glucagon-like peptide-1 (GLP-1).

Previous wording

Our wholly-owned lead product candidate, ARD-101, is an oral gut-restricted small-molecule agonist of certain TAS2Rs expressed in the gut lumen for which we have initiated a Phase 3 clinical trial for hyperphagia associated with Prader-Willi Syndrome (PWS), which is referenced as the HERO (Hunger Elimination or Reduction Objective) trial. In our completed Phase 2 clinical trial in subjects with hyperphagia associated with PWS, ARD-101 was shown to be well-tolerated and demonstrated clinical activity through a reduction in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score. We have aligned with the FDA on a protocol for a potentially pivotal Phase 3 clinical trial, which we initiated in December 2024. In preparation for these trials, we have expanded our clinical management and regulatory capabilities, including hiring clinical, regulatory and quality personnel, and we expect to continue to need to expand our clinical management and regulatory capabilities and to rely on third parties to conduct our pivotal clinical trials. Enrollment for this trial initiated in the second quarter of 2025. In August 2025, we submitted a protocol amendment to remove the use of anti-psychotics and insulin-requiring type 2 diabetes as exclusion criteria for the clinical trial. In October 2025, we reached alignment with the FDA on a protocol amendment to change the minimum age of eligibility to participate in the trial from 13 to 10 years of age. This change broadens the eligible population for the clinical trial and expands the potential target market within the PWS market. We anticipate that topline data for the HERO clinical trial will be available in the third quarter of 2026. An Independent Advisory Review Committee will conduct an interim analysis to assess whether an increase in sample size is warranted. In addition, during the third quarter of 2025, we commenced enrollment for the HERO Open Label Extension (OLE) trial and we initiated our first clinical sites in Australia. The OLE trial is available to patients completing the HERO clinical trial.

Current wording

In the second quarter of 2025, we initiated dosing for a Phase 3 clinical trial for hyperphagia associated with PWS, which we refer to as the HERO (Hunger Elimination or Reduction Objective) trial. We previously reached alignment with the FDA on a protocol for a Phase 3 clinical trial, which we initiated in December 2024. In August 2025, we submitted a protocol amendment to remove the use of anti-psychotics and insulin-requiring type 2 diabetes as exclusion criteria for the clinical trial. In October 2025, we reached alignment with the FDA on a protocol amendment to lower the minimum age of eligibility to participate in the trial from 13 to 10 years of age. This change broadened the eligible trial population and expanded the potential addressable opportunity within PWS. In December 2025, we submitted an additional protocol amendment seeking to further lower the minimum age of eligibility to participate in the trial to 7 years of age. During the third quarter of 2025, we commenced enrollment for the HERO Open Label Extension (OLE) trial, which was available to patients completing the HERO trial and we initiated our first clinical sites in Australia. In January 2026, we announced over 50% completion of the target enrollment of 90 patients in the HERO trial and within the first quarter of 2026, we initiated clinical sites in the UK, South Korea and Canada.

Previous wording

Below is a summary of our portfolio of novel and proprietary small molecule programs that we believe can induce satiety in patients with hunger-associated indications.

Current wording

Below is a summary of our portfolio of wholly-owned novel and proprietary small-molecule programs that we believe can induce satiety in patients with hunger-associated indications. As discussed above, certain clinical programs, including the HERO trial for ARD-101 and the POWER and STRENGTH trials for ARD-201, are currently paused while we evaluate safety observations and continue discussions with the FDA regarding next steps.

Previous wording

Beyond our lead product candidate, ARD-101, and our ARD-201 program, we are also developing other programs for the potential treatment of indications with high unmet need, including other indications that may be treated by activating TAS2R signaling.

Current wording

Beyond our lead product candidate, ARD-101, we are also developing other programs for the potential treatment of indications with high unmet need, including other indications mediated by TAS2R signaling.

Previous wording

Since we commenced operations in 2017, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, discovering and developing ARD-101 and developing ARD-201, establishing and maintaining our intellectual property portfolio, conducting research, preclinical studies, and clinical trials, manufacturing of ARD-101 and related raw materials, and providing general and administrative support for these operations.

Current wording

Since we commenced operations in 2017, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, discovering ARD-101, establishing and maintaining our intellectual property portfolio, conducting research, preclinical studies, and clinical trials, manufacturing of ARD-101 and related raw materials, and providing general and administrative support for these operations.

Previous wording

We have incurred significant net losses and negative cash flows from operations since our inception and, as of September 30, 2025, we had an accumulated deficit of $98.3 million. Our net losses for the three and nine months ended September 30, 2025 were $16.3 million and $40.0 million, respectively, and $4.2 million and $11.8 million for the three and nine months ended September 30, 2024, respectively. We expect our expenses and operating losses will increase substantially for the foreseeable future as we:

Current wording

We have incurred significant net losses and negative cash flows from operations since our inception and, as of March 31, 2026, we had an accumulated deficit of $137.5 million. Our net losses for the three months ended March 31, 2026 and 2025 were $21.6 million and $9.3 million, respectively. We expect our expenses and operating losses will increase substantially for the foreseeable future as we:

Previous wording

implement operational, financial and management information systems;

Current wording

implement operational, financial and management information systems; and

Previous wording

potentially experience any delays, challenges, or other issues associated with the clinical development of our product candidates, including with respect to our regulatory strategies; and

Current wording

potentially experience any delays, challenges, or other issues associated with the clinical development of our product candidates, including with respect to our regulatory strategies.

Previous wording

From inception and up to the date of our IPO in February 2025, we had raised a total of $129.1 million in gross proceeds to fund our operations from the sale and issuance of shares of our convertible preferred stock. In February 2025, we completed our IPO with the sale of 6,120,661 shares of common stock, which included the partial exercise by the underwriters of their option to purchase 232,661 additional shares, at an IPO price of $16.00 per share and received net proceeds of approximately $87.5 million. As of September 30, 2025, we had cash, cash equivalents and short-term investments of $126.4 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations into 2027. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

Current wording

From inception and up to the date of our initial public offering (IPO) in February 2025, we had raised a total of $129.1 million in gross proceeds to fund our operations from the sale and issuance of shares of our convertible preferred stock. In February 2025, we completed our IPO with the sale of 6,120,661 shares of common stock, which included the partial exercise by the underwriters of their option to purchase 232,661 additional shares, at an IPO price of $16.00 per share and received net proceeds of approximately $87.5 million. As of March 31, 2026, we had cash, cash equivalents and short-term investments of $91.2 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations into mid-2027. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In February 2026, we voluntarily paused enrollment and dosing in the Phase 3 HERO trial and the open label extension trial for ARD-101, and the POWER and STRENGTH clinical trials for ARD-201 based on reversible cardiac observations in a healthy volunteer study of ARD-101. The voluntary pause of these clinical trials may affect the timing and amount of our future expenditures and our need for additional capital, depending on the outcome of our ongoing data review and discussions with the FDA regarding next steps for our clinical programs.

Previous wording

Given our stage of development, we do not yet have a marketing or sales organization or commercial infrastructure; however, we intend to build the necessary sales, marketing and commercialization capabilities and infrastructure over time as our product candidates advance through clinical development. We expect to spend a significant amount in commercial development and marketing costs prior to obtaining regulatory and marketing approval of one or more of our product candidates.

Current wording

We have appointed a Chief Commercial Officer; however, given our stage of development, we have not yet built out a marketing or sales organization or commercial infrastructure. We intend to build the necessary sales, marketing and commercialization capabilities and infrastructure over time as our product candidates advance through clinical development if and when our product candidates advance through clinical development and receive regulatory approval. We expect to spend a significant amount in commercial development and marketing costs prior to obtaining regulatory and marketing approval of one or more of our product candidates.

Previous wording

We may be affected by unfavorable economic conditions and challenges in the United States and abroad, such as the effects of the ongoing geopolitical conflicts in Ukraine, ongoing conflicts in the Middle East, tensions in U.S.-China relations, changes in tariff rates and the implementation of any trade barriers, disruptions in the banking industry and inflationary trends. The fiscal years 2024 and 2023 were marked by significant market uncertainty and increasing inflationary pressures. These market dynamics have continued into 2025, and these and similar adverse market conditions may negatively impact our business, financial position, results of operations and growth prospects. For further discussion of the potential impacts of macroeconomic events on us, refer to Part II, Item 1A, “Risk Factors,” of this Quarterly Report.

Current wording

We may be affected by unfavorable economic conditions and challenges in the United States and abroad, such as the effects of the ongoing conflicts in the Middle East, including the war in Iran and its surrounding regions, and between Russia and Ukraine, sanctions against Russia, the instability in Venezuela, disruptions in the banking industry and inflationary trends. The fiscal years 2025 and 2024 were marked by significant market uncertainty and increasing inflationary pressures. These market dynamics are expected to continue in 2026, and these and similar adverse market conditions may negatively impact our business, financial position, results of operations and growth prospects. For further discussion of the potential impacts of macroeconomic events on us, refer to Part II, Item 1A, “Risk Factors”, of this Quarterly Report.

Previous wording

To date, we have not generated any revenue from the sale of products. We do not expect to generate any such revenue unless and until such time as ARD-101, ARD-201 and our other product candidates have advanced through clinical development and regulatory approval, if ever. If we fail to complete preclinical and clinical development of any product candidates or obtain regulatory approval for them, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.

Current wording

To date, we have not generated any revenue from the sale of products. We do not expect to generate any such revenue unless and until such time as ARD-101 and our other product candidates have advanced through clinical development and regulatory approval, if ever. If we fail to complete preclinical and clinical development of any product candidates or obtain regulatory approval for them, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.

Previous wording

Our operating expenses consist of (i) research and development expenses, (ii) general and administrative expenses and (iii) credit losses recorded on related party convertible promissory note and accounts receivable.

Current wording

Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.

Previous wording

costs related to compliance with regulatory requirements; and

Previous wording

Although R&D activities are central to our business model, the successful development of ARD-101 and our other product candidates is highly uncertain. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of ARD-101, ARD-201, or any future product candidates due to the inherently unpredictable nature of preclinical and clinical development. There are numerous factors associated with the successful development of a product candidate, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our R&D expenses will increase substantially for the foreseeable future as we continue to conduct our ongoing R&D activities, advance preclinical research programs toward clinical development, conduct clinical trials, hire additional personnel, and maintain, expand, protect, and enforce our intellectual property portfolio.

Current wording

Although R&D activities are central to our business model, the successful development of ARD-101 and our other product candidates is highly uncertain. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of ARD-101 or any other current or future product candidates due to the inherently unpredictable nature of preclinical and clinical development. There are numerous factors associated with the successful development of a product candidate, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of development generally have higher development costs than those in earlier stages of development. As a result, we expect that our R&D expenses will increase substantially for the foreseeable future as we continue to conduct our ongoing R&D activities, advance preclinical research programs toward clinical development, conduct clinical trials, hire additional personnel, and maintain, expand, protect, and enforce our intellectual property portfolio.

Previous wording

We may never succeed in achieving regulatory approval for any of our product candidates. Preclinical and clinical development timelines, the probability of success, and total development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments, and our ongoing assessments as to each product candidates’ commercial potential. We will need to raise substantial additional capital in the future. In addition, we cannot forecast which product candidate may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Current wording

The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for ARD-101 or any other current or future product candidates may be affected by a variety of factors. We may never succeed in achieving regulatory approval for any of our product candidates. Preclinical and clinical development timelines, the probability of success, and total development costs can differ materially from expectations. We anticipate that we will make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the results of ongoing and future preclinical studies and clinical trials, regulatory developments, and our ongoing assessments as to each product candidates’ commercial potential. We will need to raise substantial additional capital in the future. In addition, we cannot forecast which product candidate may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Previous wording

We expect that our G&A expenses will increase substantially for the foreseeable future as we continue to increase our general and administrative headcount to support our continued R&D activities and, if ARD-101 or our other product candidates receive marketing approval, commercialization activities, as well as to support our operations generally. We also expect to incur increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, and investor relations costs associated with operating as a public company.

Current wording

We expect that our G&A expenses will increase substantially for the foreseeable future as we continue to increase our general and administrative headcount to support our continued R&D activities and, if ARD-101 or our other product candidates receive marketing approval, commercialization activities, as well as to support our operations generally, although the timing of additional hiring may depend on the outcome of our evaluation of the voluntarily paused clinical programs.

Previous wording

R&D expenses were $13.7 million and $4.1 million for the three months ended September 30, 2025 and 2024, respectively. The $9.7 million increase for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 resulted primarily from an increase of $7.8 million for external expenses incurred for clinical studies and chemistry, manufacturing and controls (CMC) primarily related to the development of ARD-101 and a $1.8 million increase in personnel-related costs due to increased headcount.

Current wording

R&D expenses were $16.6 million and $7.8 million for the three months ended March 31, 2026 and 2025, respectively. The $8.8 million increase for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 resulted primarily from an increase of $7.1 million for external expenses incurred for chemistry, manufacturing and controls (CMC), clinical and toxicology studies primarily related to the development of ARD-101 and a $1.7 million increase in personnel-related costs due to increased headcount and bonuses.

Previous wording

G&A expenses were $4.0 million and $1.0 million for the three months ended September 30, 2025 and 2024, respectively. The $2.9 million increase for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 primarily resulted from a $1.7 million increase in personnel-related costs due to increased headcount, a $0.8 million increase in facilities and other costs and a $0.4 million increase in legal and other professional costs. The increase in non-facilities costs were partially related to commencing operations as a public company in February 2025.

Current wording

G&A expenses were $5.9 million and $2.7 million for the three months ended March 31, 2026 and 2025, respectively. The $3.2 million increase for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 resulted primarily from a $2.1 million increase in personnel-related costs due to increased headcount and bonuses, a $0.6 million increase in legal and other professional costs, and a $0.3 million increase in facilities and other costs. The increase in non-facilities costs were partially related to commencing operations as a public company in February 2025.

Previous wording

Other income, net was $1.4 million and $0.9 million for the three months ended September 30, 2025 and 2024, respectively. The $0.5 million increase for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024 resulted primarily from higher interest income generated by our higher invested cash balances.

Current wording

Other income, net was $0.9 million and $1.2 million for the three months ended March 31, 2026 and 2025, respectively. The $0.3 million decrease for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 resulted from lower interest income generated by our lower invested cash balances.

Previous wording

As of September 30, 2025, we had cash, cash equivalents and short-term investments of $126.4 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations into 2027. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies, manufacturing and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Current wording

As of March 31, 2026, we had cash, cash equivalents and short-term investments of $91.2 million. Based upon our current operating plans, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our projected operations into mid-2027. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies, manufacturing and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain. In February 2026, we voluntarily paused enrollment and dosing in our Phase 3 HERO trial and the open label extension trial for ARD-101, and the POWER and STRENGTH clinical trials for ARD-201. The voluntary pause of these clinical trials may affect the timing and amount of our future expenditures and our need for additional capital, depending on the outcome of our ongoing data review and discussions with the FDA regarding next steps for our voluntarily paused clinical programs.

Previous wording

We have incurred significant operating losses since our inception and, as of September 30, 2025, we had an accumulated deficit of $98.3 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially for the reasons described above.

Current wording

We have incurred significant operating losses since our inception and, as of March 31, 2026, we had an accumulated deficit of $137.5 million. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase substantially for the reasons described above.

Previous wording

the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and potential license or collaboration agreements with third parties;

Current wording

the timing and payment of milestone, royalty or other payments we must make pursuant to our existing and potential future license or collaboration agreements with third parties;

Previous wording

Net cash used in operating activities was $37.4 million and $10.4 million for the nine months ended September 30, 2025 and 2024, respectively. The net cash used in operating activities during the nine months ended September 30, 2025 was primarily due to our reported net loss of $40.0 million, net of non-cash items (including amortization of discount on short-term investments, unrealized gains on short-term investments, stock-based compensation expense, and non-cash lease expense) totaling $1.6 million and a $1.0 million net change of our net operating assets. Net cash used in operating activities during the nine months ended September 30, 2024 was primarily due to our reported net loss of $11.8 million, net of non-cash charges (including unrealized losses on short-term investments, credit losses, stock-based compensation expense, and non-cash lease expense) totaling $0.7 million and a $0.8 million net decrease of our net operating assets. The increase in cash used in operations during the nine months ended September 30, 2025 in comparison to the nine months ended September 30, 2024 was primarily attributable to increased research and development activities.

Current wording

Net cash used in operating activities was $18.9 million and $11.4 million for the three months ended March 31, 2026 and 2025, respectively. The net cash used in operating activities during the three months ended March 31, 2026 was primarily due to our reported net loss of $21.6 million, net of non-cash items (including unrealized losses on short-term investments, stock-based compensation expense, non-cash lease expense and amortization of discount on short-term investments) totaling $2.0 million and a $0.7 million net decrease of our net operating assets. The net cash used in operating activities during the three months ended March 31, 2025 was primarily due to our reported net loss of $9.3 million, net of non-cash charges (including unrealized losses on short-term investments, stock-based compensation expense, non-cash lease expense and amortization of discount on short-term investments) totaling $0.3 million and a $2.4 million net increase of our net operating assets. The increase in cash used in operations during the three months ended March 31, 2026 in comparison to the three months ended March 31, 2025 was primarily attributable to increased research and development activities.

Previous wording

Net cash used in investing activities was $74.0 million during the nine months ended September 30, 2025 primarily as a result of the purchase of short-term investments during the period, offset by maturities of short-term investments during the period and purchases of equipment. Net cash used in investing activities was $0.1 million during the nine months ended September 30, 2024 as a result of the purchase of property and equipment during the period.

Current wording

Net cash provided by investing activities during the three months ended March 31, 2026 was $34.3 million resulting from the sales and maturities of short-term investments during the period. Net cash used in investing activities was $112.6 million during the three months ended March 31, 2025 primarily as a result of the purchase of short-term investments during the period, offset by maturities of short-term investments during the period.

Previous wording

Net cash provided by financing activities was $89.0 million during the nine months ended September 30, 2025 primarily as a result of proceeds from the sale and issuance of shares of our common stock in our IPO in February 2025 for proceeds of $91.1 million, net of underwriting discounts, offset by payments for IPO costs of $2.4 million. Net cash provided by financing activities was $83.0 million during the nine months ended September 30, 2024 primarily as a result of the sale and issuance of shares of our Series C convertible preferred stock in May 2024 for net proceeds of $82.9 million.

Current wording

Net cash provided by financing activities during the three months ended March 31, 2026 was $4,000 and resulted from sales of common stock under our employee equity plans. Net cash provided by financing activities during the three months ended March 31, 2025 was $88.9 million and resulted primarily from the proceeds from the sale and issuance of shares of our common stock in our IPO in February 2025 for proceeds of $91.1 million, offset by payments for IPO costs of $2.3 million.
Rearranged previous paragraphs (5)

Previous report — wording carried elsewhere

The process of conducting the necessary preclinical and clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for ARD-101 or any future product candidates may be affected by a variety of factors.

Previous report — wording carried elsewhere

The following table summarizes our results of operations for each of the periods indicated:

Previous report — wording carried elsewhere

The following table summarizes our R&D expenses for each of the periods indicated:

Previous report — wording carried elsewhere

General and Administrative (G&A) Expenses

Previous report — wording carried elsewhere

G&A expenses were $9.4 million and $3.9 million for the nine months ended September 30, 2025 and 2024, respectively. The $5.5 million increase for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024 primarily resulted from a $2.7 million increase in personnel-related costs, a $1.9 million increase in facilities and other costs and a $0.9 million increase in legal and other professional costs. The increase in non-facilities costs were partially related to commencing operations as a public company in February 2025.