AARD 8-K
Aardvark Therapeutics, Inc. (AARD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 March 31, 2025, Aardvark Therapeutics, Inc. issued a press release reporting its financial results for the year ended December 31, 2024 and providing a business update. 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.
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Exhibit |
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Description |
99.1 |
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104 |
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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.
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AARDVARK THERAPEUTICS, INC. |
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Date: |
March 31, 2025 |
By: |
/s/ Tien-Li Lee, M.D. |
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Tien-Li Lee, M.D. |
Exhibit 99.1
Aardvark Therapeutics Reports Full Year 2024 Financial Results and Provides Business Highlights
SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (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 full year ended December 31, 2024, and provided business highlights.
“Appetite represents a reward-based neurological drive and hunger represents a penalty or pain avoidance neurological drive. Many approved obesity medications, including GLP-1RA agents, primarily regulate appetite, and Aardvark believes there is a significant, untapped opportunity to target anti-hunger signaling to treat metabolic rare diseases and obesity,” said Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark. ARD-101 is intended to address hunger by lowering the discomfort of fasting without notably decreasing the appeal of food or inducing nausea. We are pursuing certain medical conditions related to overeating or hyperphagia that may be primarily driven by hunger more than appetite, including Prader-Willi Syndrome, hypothalamic obesity, and at least some subsets of general obesity.
Summary of Business Highlights
Anticipated Milestones
Select Full Year 2024 Financial Highlights
About Aardvark Therapeutics, Inc.
Aardvark is a clinical-stage biopharmaceutical company developing novel, small-molecule therapeutics designed to suppress hunger for the treatment of PWS and metabolic diseases. Recognizing hunger (the discomfort from not having eaten recently) is a distinct neural signaling pathway separate from appetite (the reward-seeking, desirability of food), our programs explore therapeutic applications in hunger associated indications and potential complementary uses with anti-appetite therapies. Our lead compound, oral ARD-101, is in Phase 3 clinical development for the treatment of hyperphagia associated with PWS, a rare disease characterized by insatiable hunger. ARD-101 is also being studied in hypothalamic obesity. Aardvark is also developing ARD-201, a fixed-dose combination of ARD-101 with a DPP-4 inhibitor, with a goal of addressing some of the limitations of currently marketed GLP-1 therapies for the treatment of obesity and obesity-related conditions. For more information, visit 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 future results of operations and financial position, business strategy, product candidates, ongoing clinical trials, planned clinical trials, expected timing for data readouts and reporting topline results, anticipated cash runway, 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. 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, enrollment and completion of clinical trials; the risk that we may use our capital resources sooner than expected and that they may be insufficient to allow us to achieve our anticipated milestones; risks related to our dependence on third parties for manufacturing, shipping and clinical and preclinical trials; the risk that results from earlier clinical trials and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Aardvark’s Annual Report on Form 10-K for the year ended December 31, 2024 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.
Contact:
Carolyn Hawley, Inizio Evoke Comms
(619) 849-5382
Aardvark Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
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Year Ended December 31, |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
$ |
17,363 |
$ |
4,480 |
General and administrative |
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5,305 |
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2,173 |
Credit loss—related party accounts receivable |
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117 |
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762 |
Total operating expenses |
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22,785 |
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7,415 |
Loss from operations |
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(22,785) |
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(7,415) |
Total other income, net |
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2,197 |
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207 |
Net loss and comprehensive net loss |
$ |
(20,588) |
$ |
(7,208) |
Net loss per share of common stock, basic and diluted |
$ |
(5.15) |
$ |
(1.82) |
Weighted-average shares used in net loss per share calculation |
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3,996,376 |
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3,960,944 |
Aardvark Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts)
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December 31, |
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2024 |
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2023 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
61,641 |
$ |
9,735 |
Short-term investments |
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12,022 |
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254 |
Prepaid expenses and other current assets |
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474 |
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379 |
Total current assets |
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74,137 |
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10,368 |
Operating lease right-of-use asset |
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735 |
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155 |
Other assets |
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2,635 |
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13 |
Total assets |
$ |
77,507 |
$ |
10,536 |
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit |
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Current liabilities: |
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Accounts payable |
$ |
2,298 |
$ |
1,035 |
Accrued liabilities |
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2,291 |
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235 |
Operating lease liability, current portion |
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338 |
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112 |
Total current liabilities |
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4,927 |
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1,382 |
Operating lease liability, net of current portion |
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441 |
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50 |
Other long-term liabilities |
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26 |
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2 |
Total liabilities |
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5,394 |
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1,434 |
Commitments and contingencies |
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Convertible preferred stock |
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126,756 |
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43,904 |
Stockholders’ deficit: |
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Common stock |
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- |
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- |
Additional paid-in-capital |
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3,684 |
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2,937 |
Accumulated deficit |
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(58,327) |
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(37,739) |
Total stockholders’ deficit |
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(54,643) |
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(34,802) |
Total liabilities, convertible preferred stock, and stockholders’ deficit |
$ |
77,507 |
$ |
10,536 |