Aardvark Therapeutics, Inc.

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). 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). We also intend to evaluate ARD-101 in a Phase 2 clinical trial for hyperphagia associated with hypothalamic obesity (HO). 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, and we anticipate topline data will be available in early 2026. In furtherance of preparing for this potentially pivotal Phase 3 clinical trial, 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.

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. 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.

Previous wording

We have incurred significant net losses and negative cash flows from operations since our inception and, as of March 31, 2025, we had an accumulated deficit of $67.6 million. Our net losses for the three months ended March 31, 2025 and 2024 were $9.3 million and $2.2 million, 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 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:

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 March 31, 2025, we had cash, cash equivalents and short-term investments of $151.3 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 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.

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, 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 are expected to continue 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, 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.

Previous wording

costs related to compliance with regulatory requirements;

Current wording

costs related to compliance with regulatory requirements; and

Previous wording

R&D expenses were $7.8 million and $1.2 million for the three months ended March 31, 2025 and 2024, respectively. The $6.5 million increase for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 resulted primarily from an increase of $4.8 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 and bonuses.

Current 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.

Previous wording

Amounts written off as uncollectible related to the Transition Services Agreement with Aardwolf were zero and $0.1 million for the three months ended March 31, 2025 and 2024, respectively. The $0.1 million decrease for the three months ended March 31, 2025 as compared to the three months ended March 31, 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 $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 wording

Other income, net was $1.2 million and expense of $7,000 for the three months ended March 31, 2025 and 2024, respectively. The $1.2 million increase for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 resulted from higher interest income generated by our higher invested cash balances and lower unrealized losses recorded on the change in the fair value of our short-term investments.

Current 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.

Previous wording

G&A expenses were $2.7 million and $0.9 million for the three months ended March 31, 2025 and 2024, respectively. The $1.9 million increase for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 primarily resulted from a $0.9 million increase in legal and other professional costs, a $0.6 million increase in facilities and other costs and a $0.3 million increase in personnel-related 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 $5.4 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.

Previous wording

As of March 31, 2025, we had cash, cash equivalents and short-term investments of $151.3 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 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.

Previous wording

We have incurred significant operating losses since our inception and, as of March 31, 2025, we had an accumulated deficit of $67.6 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 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.

Previous wording

Net cash used in operating activities was $11.4 million and $2.2 million for the three months ended March 31, 2025 and 2024, respectively. 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 items (including unrealized losses on short-term investments, credit losses, stock-based compensation expense and right-of-use asset amortization) totaling $0.3 million and a $2.4 million net increase of our net operating assets. The net cash used in operating activities during the three months ended March 31, 2024 was primarily due to our reported net loss of $2.2 million, net of non-cash charges (including non-cash dividend income, unrealized losses on short-term investments, credit losses, stock-based compensation expense, and right-of-use asset amortization) totaling $0.3 million and a $0.3 million net increase of our net operating assets. The increase in cash used in operations during the three months ended March 31, 2025 in comparison to the three months ended March 31 2024 was primarily attributable to increased research and development activities.

Current 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.

Previous wording

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.

Current 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.

Previous wording

Net cash provided by financing activities was $88.9 million during the three months ended March 31, 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, offset by payments for IPO costs of $2.3 million.

Current 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.