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Aardvark Therapeutics, Inc.

For the period ended Sep 30, 2025. Filed Nov 13, 2025.

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.

Sep 30, 2025 · Filed Nov 13, 2025

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 2025-06-30; filed 2025-08-13.

0000950170-25-108116

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

Current 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

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 177 previous paragraphs and 184 current paragraphs.

148 unchanged; 26 reworded; 8 added; 1 removed; 2 previous and 2 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 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 (8)

Current 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.

Current 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.

Current 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.

Current 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.

Current 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.

Current 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.

Current 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.

Current report

Comparison of the Nine Months ended September 30, 2025 and 2024
Removed paragraphs (1)
Reworded paragraphs (26)

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. Additionally, we intend to expand enrollment to include patients under 13 years of age, thereby broadening the eligible population for the clinical trial and increasing the potential target population within the PWS market. As a consequence of the expanded enrollment, we now 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 if sample size should increase. We will have an open label extension trial available to patients after completing the HERO clinical trial.

Current 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.

Previous wording

We also intend to evaluate ARD-101 in a Phase 2 clinical trial for hyperphagia associated with hypothalamic obesity (HO), which is referenced as the HONOR (Hypothalamic Obesity Neutralized On TAS2 R) trial. We plan to initiate this trial in the second half of 2025 with anticipated topline data readout in the second half of 2026.

Current wording

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 wording

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 fixed-dose 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. 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.

Current wording

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 wording

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 will not already be 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.

Current wording

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 wording

(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) ± SEM (bars) for each treatment group.

Current wording

(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 wording

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 will be submitted for peer review publication.

Current wording

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 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 mediated by TAS2R signaling.

Current 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.

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 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.

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 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.

Previous wording

We have incurred significant net losses and negative cash flows from operations since our inception and, as of June 30, 2025, we had an accumulated deficit of $82.0 million. Our net losses for the three and six months ended June 30, 2025 were $14.4 million and $23.7 million, respectively, and $5.4 million and $7.6 million for the three and six months ended June 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 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:

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 June 30, 2025, we had cash, cash equivalents and short-term investments of $141.8 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 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.

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, the Israel-Hamas war, ongoing conflicts between Israel and Iran, 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 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.

Previous 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 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.

Current 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.

Previous wording

R&D expenses were $13.1 million and $4.0 million for the three months ended June 30, 2025 and 2024, respectively. The $9.1 million increase for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 resulted primarily from an increase of $7.3 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 $1.6 million increase in personnel-related costs due to increased headcount.

Current 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.

Previous wording

G&A expenses were $2.7 million and $2.0 million for the three months ended June 30, 2025 and 2024, respectively. The $0.7 million increase for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 primarily resulted from a $0.6 million increase in personnel-related costs due to increased headcount, a $0.5 million increase in facilities and other costs, partially offset by a $0.4 million decrease 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 $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.

Previous wording

Other income, net was $1.5 million and $0.6 million for the three months ended June 30, 2025 and 2024, respectively. The $0.9 million increase for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 resulted primarily from higher interest income generated by our higher invested cash balances.

Current 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.

Previous wording

R&D expenses were $20.9 million and $5.2 million for the six months ended June 30, 2025 and 2024, respectively. The $15.7 million increase for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 resulted primarily from an increase of $12.1 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 $3.2 million increase in personnel-related costs due to increased headcount.

Current wording

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 wording

G&A expenses were $5.4 million and $2.9 million for the six months ended June 30, 2025 and 2024, respectively. The $2.5 million increase for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 primarily resulted from a $1.1 million increase in facilities and other costs, $0.9 million increase in personnel-related costs and a $0.5 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 $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.

Previous wording

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

Current wording

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 wording

Other income, net was $2.6 million and expense of $0.6 million for the six months ended June 30, 2025 and 2024, respectively. The $2.0 million increase for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 resulted primarily from higher interest income generated by our higher invested cash balances.

Current wording

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.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and short-term investments of $141.8 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 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.

Previous wording

We have incurred significant operating losses since our inception and, as of June 30, 2025, we had an accumulated deficit of $82.0 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 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.

Previous 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;

Current 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;

Previous wording

Net cash used in operating activities was $21.2 million and $6.4 million for the six months ended June 30, 2025 and 2024, respectively. The net cash used in operating activities during the six months ended June 30, 2025 was primarily due to our reported net loss of $23.7 million, net of non-cash items (including amortization of discount on short-term investments, unrealized losses on short-term investments, stock-based compensation expense, and right-of-use asset amortization) totaling $0.4 million and a $2.0 million net change of our net operating assets. The net cash used in operating activities during the six months ended June 30, 2024 was primarily due to our reported net loss of $7.6 million, net of non-cash charges (including unrealized losses on short-term investments, credit losses, stock-based compensation expense, and right-of-use asset amortization) totaling $0.4 million and a $0.9 million net change of our net operating assets. The increase in cash used in operations during the six months ended June 30, 2025 in comparison to the six months ended June 30, 2024 was primarily attributable to increased research and development activities.

Current 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.

Previous wording

Net cash used in investing activities was $103.2 million during the six months ended June 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.

Current 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.

Previous wording

Net cash provided by financing activities was $88.8 million during the six months ended June 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.

Current 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.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

(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.

Current report — wording carried from 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.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Amounts written off as uncollectible related to the Transition Services Agreement with Aardwolf were zero and $14,000 for the three months ended June 30, 2025 and 2024, respectively. The decrease for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 was due to the expiration of the Transition Services Agreement in May 2024.

Previous report — wording carried elsewhere

Credit Loss – Related Party Accounts Receivable