STOCK TITAN
  1. Home
  2. Sec-filings
  3. AARD
  4. [8-K] Aardvark Therapeutics, Inc. Reports Material Event

Aardvark Therapeutics (AARD) details Q2 2026 loss, FDA hold and cash runway

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Aardvark Therapeutics reported second quarter 2026 results and major pipeline developments for ARD-101 in Prader-Willi Syndrome. The company is assessing unblinded Phase 3 HERO and Open Label Extension data in the third quarter of 2026 to determine next steps after terminating both trials in June 2026. In May 2026, the FDA placed a full clinical hold on the ARD-101 investigational new drug application, covering all ongoing studies.

Aardvark held $73.9 million in cash, cash equivalents and short-term investments as of June 30, 2026, which it believes will fund operations into late 2027. Second quarter 2026 research and development expenses were $10.5 million, down from $13.1 million a year earlier, while general and administrative expenses increased to $4.6 million from $2.7 million. Net loss was $14.4 million, consistent with the prior-year quarter, and total assets declined to $81.5 million from $117.2 million at December 31, 2025.

Positive

  • $73.9 million in cash, cash equivalents and short-term investments as of June 30, 2026, is expected to fund projected operations into late 2027.
  • Second quarter 2026 R&D expenses declined to $10.5 million from $13.1 million in the prior-year quarter, reflecting lower external clinical and CMC spending.

Negative

  • The FDA placed a full clinical hold on the ARD-101 IND in May 2026, affecting all ongoing clinical studies including the Phase 3 HERO and OLE trials.
  • Aardvark terminated the Phase 3 HERO and Open Label Extension trials for ARD-101 in PWS in June 2026 and does not currently intend to resume them as previously designed.
  • Total assets fell to $81.5 million at June 30, 2026 from $117.2 million at December 31, 2025, and stockholders’ equity declined to $74.8 million from $106.6 million.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash, cash equivalents and short-term investments $73.9 million As of June 30, 2026; expected to fund operations into late 2027
R&D expenses Q2 2026 $10.5 million Research and development expenses for the three months ended June 30, 2026 vs $13.1 million in 2025
G&A expenses Q2 2026 $4.629 million General and administrative expenses for the three months ended June 30, 2026 vs $2.703 million in 2025
Net loss Q2 2026 $14.387 million Net loss for the three months ended June 30, 2026 and 2025
Net loss per share Q2 2026 $0.66 Basic and diluted net loss per share for the quarter ended June 30, 2026 and 2025
Total assets $81.460 million Total assets at June 30, 2026 vs $117.181 million at December 31, 2025
Stockholders’ equity $74.797 million Total stockholders’ equity at June 30, 2026 vs $106.633 million at December 31, 2025
Weighted-average shares Q2 2026 21,846,251 Weighted-average shares used in net loss per share calculation for the three months ended June 30, 2026
clinical hold regulatory
"the U.S. Food and Drug Administration (FDA) placed a full clinical hold on its investigational"
A clinical hold is an order from a drug or medical-device regulator to stop or suspend a clinical trial or development activity because of safety concerns, inadequate study plans, or incomplete data. Think of it like a referee pausing a game until rules or safety issues are resolved; investors care because a hold can delay approval, increase costs, create uncertainty about a product’s future, and often affects a company’s valuation until the issues are addressed.
Prader-Willi Syndrome medical
"Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome"
A rare genetic disorder caused by missing or altered instructions on a specific chromosome that leads to constant hunger, low muscle tone, learning challenges, and hormonal problems; think of it as a faulty instruction manual that affects growth, appetite control, and development. Investors care because the condition creates a defined patient population, special regulatory incentives, and long-term medical needs that shape demand for therapies, diagnostics, and care services, influencing market size and risk for drug developers.
Open Label Extension medical
"both the HERO (Hunger Elimination or Reduction Objective) trial and the OLE (Open Label Extension) trial"
An open-label extension is a follow-on phase of a clinical trial where participants keep receiving the experimental drug and both doctors and patients know what treatment is being given. It matters to investors because it produces longer-term safety and effectiveness information, helps regulators and companies assess ongoing benefits or risks, and can indicate whether a therapy has staying commercial value — like an extended test drive revealing durability and real-world performance.
operating lease right-of-use asset financial
"Operating lease right-of-use asset | | 626 | | 355 Other assets"
An operating lease right-of-use asset is the accounting entry that shows a company’s recorded value of its legal right to use leased property or equipment for a set period, similar to listing the worth of a long-term rental agreement on the balance sheet. It matters to investors because it makes leased obligations and the economic benefit of rented assets visible, affecting reported assets, leverage and how future lease costs are reflected in financial statements — like seeing both a rented shop’s utility and the remaining rent commitment.
accumulated deficit financial
"Accumulated deficit | | (151,893) | | (115,918)"
Accumulated deficit is the running total of a company’s past net losses minus any profits, showing how much the business has eaten into its own funds over time—think of it like a bank account that’s been overdrawn by repeated shortfalls. It matters to investors because a large accumulated deficit reduces the cushion that protects owners and creditors, can limit dividends or borrowing, and signals how much funding the company may need to reach profitability.
Net loss $14.387 million Net loss of $14.387 million in Q2 2026 vs $14.367 million in Q2 2025
R&D expenses $10.455 million R&D expenses of $10.455 million in Q2 2026 vs $13.145 million in Q2 2025
G&A expenses $4.629 million G&A expenses of $4.629 million in Q2 2026 vs $2.703 million in Q2 2025
Cash and investments $73.9 million Cash, cash equivalents and short-term investments of $73.9 million as of June 30, 2026 vs $91.2 million as of March 31, 2026
Guidance

The company believes existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into late 2027.

FAQ

What were Aardvark Therapeutics (AARD) key financial results for Q2 2026?
Aardvark reported a net loss of $14.4 million for Q2 2026, unchanged from Q2 2025. R&D expenses were $10.5 million and G&A expenses were $4.6 million, with basic and diluted net loss per share of $0.66.

How much cash does Aardvark Therapeutics (AARD) have and what is its runway?
As of June 30, 2026, Aardvark had $73.9 million in cash, cash equivalents and short-term investments. The company states this is sufficient to fund projected operations into late 2027 based on current operating plans.

What is the status of Aardvark Therapeutics’ ARD-101 program in PWS?
The ARD-101 program is under a full FDA clinical hold placed in May 2026, covering all studies. Aardvark terminated the Phase 3 HERO and OLE trials in June 2026 and is assessing unblinded data in Q3 2026 to determine next steps.

How did Aardvark Therapeutics (AARD) R&D and G&A expenses change year over year?
For Q2 2026, R&D expenses were $10.5 million, down from $13.1 million in Q2 2025, mainly due to lower external clinical and CMC costs. G&A expenses increased to $4.6 million from $2.7 million, reflecting public-company costs, higher headcount, bonuses and severance.

What does Aardvark Therapeutics’ (AARD) balance sheet look like at June 30, 2026?
At June 30, 2026, Aardvark reported $81.5 million in total assets and $6.7 million in total liabilities. Stockholders’ equity was $74.8 million, with 21,884,158 common shares issued and outstanding.

What clinical and regulatory steps is Aardvark Therapeutics (AARD) planning next?
Aardvark is assessing unblinded HERO and OLE data for ARD-101 in Q3 2026 to inform future plans for its PWS program and remains in active discussions with the FDA to resolve the clinical hold.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
Understanding 8-K Material Events →
0001774857false00017748572026-08-112026-08-11

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2026

 

 

Aardvark Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-42513

82-1606367

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

4370 La Jolla Village Drive, Suite 1050

 

San Diego, California

 

92122

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (858) 225-7696

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.00001 per share

 

AARD

 

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Item 2.02 Results of Operations and Financial Condition.

On August 11, 2026, Aardvark Therapeutics, Inc. issued a press release reporting its financial results for the second quarter ended June 30, 2026, and providing business updates. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

 

 

Exhibit
No.

Description

99.1

Press Release, dated August 11, 2026.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

AARDVARK THERAPEUTICS, INC.

 

 

 

 

Date:

August 11, 2026

By:

/s/ Tien-Li Lee, M.D.

 

 

 

Tien-Li Lee, M.D.
Chief Executive Officer

 

Exhibit 99.1

 

Aardvark Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Updates

Assessing unblinded Phase 3 HERO and OLE data for ARD-101 in PWS in the third quarter of 2026 to support an informed determination of next steps

Remains in active discussions with the FDA to support resolution of the clinical hold for ARD-101 program

$73.9 million in cash, cash equivalents and short-term investments as of June 30, 2026, supports projected operations into late 2027

SAN DIEGO, August 11, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark or the Company) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today reported financial results for the second quarter ended June 30, 2026, and provided pipeline and business updates.

“Patients and families in the PWS community are at the center of every decision we make, and our team is laser focused on establishing a clear path forward for ARD-101 in PWS,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. “Over the last several months, we have continued to work collaboratively with the FDA. Additionally in the third quarter of this year, we are assessing the unblinded data from the HERO and OLE trials, which will allow us to understand the totality of the efficacy and safety results generated to date.”

Pipeline Updates

•
Aardvark is assessing the unblinded clinical data accumulated to date across both the HERO (Hunger Elimination or Reduction Objective) trial and the OLE (Open Label Extension) trial to assess the totality of available efficacy and safety data and to support an informed determination of next steps for the ARD-101 program. In June 2026, the Company terminated the HERO and the OLE trial and does not currently intend to resume these trials as previously designed.
•
In May 2026, the Company announced that the U.S. Food and Drug Administration (FDA) placed a full clinical hold on its investigational new drug application (IND) for ARD-101, related to the Company’s previously announced voluntary pause. The clinical hold applies to all previously ongoing clinical studies under the IND, including the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome (PWS) and the Phase 3 OLE trial.

 

 

 

Second Quarter 2026 Financial Highlights

•
Cash Position: As of June 30, 2026, Aardvark had cash, cash equivalents and short-term investments of $73.9 million, compared to $91.2 million as of March 31, 2026. Based on current operating plans, Aardvark believes that its existing cash, cash equivalents and short-term investments will be sufficient to fund projected operations into late 2027.
•
Research & Development (R&D): R&D expenses for the second quarter of 2026 were $10.5 million, compared to $13.1 million for the second quarter of 2025. The $2.7 million decrease for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 resulted primarily from a decrease of $3.3 million for external expenses incurred for CMC, clinical and toxicology studies primarily related to the development of ARD-101 as a result of the voluntary pause of all of our clinical trials and the subsequent clinical hold on our IND for ARD-101, offset by a $0.7 million increase in personnel-related costs due to increased headcount and bonuses prior to the workforce reduction implemented in June 2026.
•
General & Administrative (G&A): G&A expenses for the second quarter of 2026 were $4.6 million, compared to $2.7 million for the second quarter of 2025. The $1.9 million increase for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 included additional public company operating costs and resulted primarily from an increase in personnel-related costs due to year-over-year increased headcount prior to the workforce reduction implemented in June 2026 associated with the voluntary pause of all of our clinical trials and the subsequent clinical hold on our IND for ARD-101, bonuses and $0.5 million in severance expense.
•
Net loss: Aardvark reported a net loss of $14.4 million for each of the second quarters of 2026 and 2025.

About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of Prader-Willi Syndrome (PWS) and metabolic diseases. Hunger, which is the discomfort from not having eaten recently, is a distinct neural signaling pathway separate from appetite, the reward-seeking desire for food. Our programs explore therapeutic applications in hunger-associated indications and potential complementary uses with anti-appetite therapies. For more information, visit www.aardvarktherapeutics.com.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute

 

 

“forward-looking statements.” These statements include, but are not limited to, statements concerning: Aardvark’s business strategy, product candidates, paused clinical trials, planned clinical trials, likelihood of success, as well as plans and objectives of management for future operations. The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include statements regarding Aardvark’s anticipated cash runway, Aardvark’s discussions with the FDA, Aardvark’s unblinding and assessment of HERO and OLE trial data, and Aardvark’s future plans for its PWS program. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to potential delays in the commencement, recommencement, enrollment and completion of clinical trials and any additional actions that may be required by the FDA; the risk that Aardvark may use its capital resources sooner than expected and that they may be insufficient to allow Aardvark to achieve its anticipated milestones; the possibility that the past track records of Aardvark and its personnel may not be repeated or indicative of future success; risks related to its dependence on third parties for manufacturing, shipping and production of drug product for use in clinical trials and preclinical studies; the risk of unfavorable clinical trial results; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other risks and uncertainties, including the factors described under the “Risk Factors” section of Aardvark’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 to be filed with the Securities and Exchange Commission on or about the date hereof. When evaluating Aardvark’s business and prospects, careful consideration should be given to these risks and uncertainties. Any forward-looking statements contained in this press release are based on the current expectations of Aardvark’s management team and speak only as of the date hereof, and Aardvark specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, unless required by law.

Investor and Media Contact:

Courtney Mogerley

Argot Partners

(212) 600-1902

Aardvark@Argotpartners.com

 

 

 

 

Aardvark Therapeutics, Inc.

Unaudited Condensed Consolidated Statements of Operations

and Comprehensive Loss

(in thousands, except share and per share data)

 

 

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 

 

2026

 

2025

 

2026

 

2025

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

     Research and development

$

10,455

$

13,145

$

27,022

$

20,900

     General and administrative

 

4,629

 

2,703

 

10,526

 

5,418

          Total operating expenses

 

15,084

 

15,848

 

37,548

 

26,318

Loss from operations

 

(15,084)

 

  (15,848)

 

  (37,548)

 

  (26,318)

Total other income, net

 

 697

 

1,481

 

 1,573

 

2,641

Net loss

$

(14,387)

$

(14,367)

$

 (35,975)

$

(23,677)

Net loss per share of common stock, basic and diluted

 

 

$

 

 

(0.66)

 

 

$

 

 

(0.66)

$

 

 

(1.65)

$

 

 

(1.36)

Weighted-average shares used in net loss per share calculation

 

 21,846,251

 

 

21,690,275

 

21,831,206

 

17,465,965

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Aardvark Therapeutics, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and par value data)

 

 

 

June 30, 2026

 

December 31, 2025

 

 

(unaudited)

 

 

Assets

 

 

 

 

Current assets:

 

 

 

 

     Cash and cash equivalents

$

73,849

$

47,051

     Short-term investments

 

21

 

62,976

     Prepaid expenses and other current assets

 

6,791

 

1,859

          Total current assets

 

80,661

 

111,886

 Operating lease right-of-use asset

 

626

 

355

 Other assets

 

173

 

4,940

          Total assets

$

81,460

$

117,181

Liabilities and Stockholders’ Equity

 

 

 

 

Current liabilities:

 

 

 

 

     Accounts payable

$

2,086

$

2,072

     Accrued liabilities

 

3,900

 

8,035

    Operating lease liability, current portion

 

401

 

441

          Total current liabilities

 

6,387

 

10,548

Operating lease liability, net of current portion

 

276

 

—

          Total liabilities

 

6,663

 

10,548

 Commitments and contingencies

 

 

 

 

 Stockholders’ equity:

 

 

 

 

     Preferred stock, $0.00001 par value; 10,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025

 

—

 

—

     Common stock, $0.00001 par value; 490,000,000 shares authorized at June 30, 2026 and December 31, 2025; 21,884,158 and 21,815,353 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively

 

—

 

—

     Additional paid-in-capital

 

226,690

 

222,470

Accumulated other comprehensive income

 

—

 

81

     Accumulated deficit

 

(151,893)

 

(115,918)

          Total stockholders’ equity

 

74,797

 

106,633

             Total liabilities and stockholders’ equity

$

81,460

$

117,181

 

 

 

 

 

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

2 documents

Press Releases

Other Documents