Aardvark Therapeutics Reports Full Year 2024 Financial Results and Provides Business Highlights

Rhea-AI Summary

Aardvark Therapeutics (NASDAQ: AARD) reported its full year 2024 financial results and business highlights. The company's lead candidate ARD-101 showed promising results in a Phase 2 trial for Prader-Willi Syndrome (PWS), demonstrating up to 16-point HQ-CT reduction in hyperphagia and improvements in body composition over 28 days.

The company successfully completed its IPO in February 2025, raising $97.9 million in gross proceeds. Financial results show cash position of $73.7 million as of December 31, 2024. R&D expenses increased to $17.4 million from $4.5 million in 2023, while G&A expenses rose to $5.3 million from $2.2 million. Net loss widened to $20.6 million from $7.2 million in 2023.

Key upcoming milestones include Phase 2 HONOR trial initiation for hypothalamic obesity and Phase 2 EMPOWER trial for ARD-201 in H2 2025, with Phase 3 HERO trial topline data expected in early 2026.

Positive

• Successful Phase 2 trial results showing up to 16-point reduction in hyperphagia
• Strong cash position of $73.7M plus $97.9M IPO proceeds extending runway into 2027
• Positive body composition changes in Phase 2 trial (1.5% fat reduction, 2% lean muscle increase)
• Multiple clinical pipeline advancements with Phase 2 and 3 trials planned

Negative

• Net loss increased significantly to $20.6M from $7.2M YoY
• R&D expenses increased substantially to $17.4M from $4.5M YoY
• G&A expenses more than doubled to $5.3M from $2.2M YoY

Insights

Biotech Analyst

Aardvark Therapeutics' 2024 financial results reveal a significant advancement in their clinical programs despite widening losses. Their lead candidate ARD-101 demonstrated promising efficacy in their Phase 2 PWS trial, showing meaningful reductions in hyperphagia (up to 16-point HQ-CT reduction) and positive trends in body composition with decreased body fat and increased lean muscle.

The company's financial position has been substantially strengthened through their February 2025 IPO, raising $97.9 million in gross proceeds. This, combined with their $73.7 million year-end cash position, provides runway into 2027—a critical cushion for a clinical-stage biotech advancing multiple programs.

While R&D expenses increased 287% to $17.4 million and G&A expenses rose 141% to $5.3 million, these increases reflect appropriate investment in pipeline development. The ongoing pivotal Phase 3 HERO trial for PWS represents a potential near-term value inflection point with topline data expected in early 2026.

Aardvark's approach targeting anti-hunger signaling pathways differentiates them in the metabolic disease space where most competitors focus on appetite regulation. With multiple trials planned in 2025 (Phase 2 HONOR for hypothalamic obesity and Phase 2 EMPOWER for general obesity), the company is establishing a diversified clinical pipeline addressing significant unmet needs in rare metabolic disorders.

Financial Analyst

Aardvark's financial trajectory shows the classic biotech development pattern—expanding investment balanced with strategic capital raising. Their $20.6 million net loss (up from $7.2 million) reflects deliberate acceleration of R&D spending, which nearly quadrupled to $17.4 million. This increased burn rate is well-supported by their robust capital position.

The February 2025 IPO raising $97.9 million was perfectly timed to build upon their $73.7 million year-end cash position. This combined capital provides approximately 2+ years of runway—critical breathing room for their Phase 3 program and multiple Phase 2 trials. For a company with $186 million market cap, this financial cushion significantly reduces near-term funding risk.

G&A expense growth to $5.3 million appears disciplined at 24% of total operating expenses, maintaining an appropriate ratio of clinical investment to overhead. The concentration of spending on ARD-101's clinical development shows focused resource allocation toward their most advanced asset.

Looking ahead, the company's catalysts are well-sequenced, with multiple trial initiations in 2025 followed by Phase 3 data in early 2026. This strategic staging of milestones provides multiple opportunities for value creation before requiring additional capital. With promising clinical signals in hand and funding secured through these key milestones, Aardvark has effectively de-risked their near-term operations while maintaining full ownership of their pipeline assets.

• Lead candidate ARD-101 demonstrated clinical activity and was generally well tolerated in a two-part Phase 2 trial in Prader-Willi Syndrome (PWS), with meaningful reductions in hyperphagia (up to a 16-point HQ-CT reduction, with an average reduction of approximately 8 points among subjects that followed trial protocol) observed during the 28-day dosing period.
• DEXA scans analysis from the PWS Phase 2 trial data measuring body composition indicated a trend toward decreased body fat (approximately 1.5%) and increased lean muscle (over 2%) following 28 days of ARD-101 dosing.
• Ongoing ARD-101 Phase 3 HERO trial to treat hyperphagia associated with PWS is expected to generate topline data in early 2026. 
• Aardvark bolstered its cash runway through the successful completion of its Initial Public Offering (IPO) in February 2025.

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

• Phase 2 data for the treatment of hyperphagia associated with PWS showed multiple encouraging signals. As a result, Aardvark has advanced its clinical pipeline with the initiation of the potentially pivotal Phase 3 HERO (Hunger Elimination or Reduction Objective) trial evaluating ARD-101 for hyperphagia associated with PWS.
• Achieved a successful IPO with $97.9 million in gross proceeds to support ongoing and future pipeline development.
• Strengthened executive leadership with the addition of Manasi Sinha Jaiman, M.D., M.P.H., a proven clinical strategist, as Chief Medical Officer.
• Enhanced board expertise with the appointment of Roy D. Baynes, M.D., Ph.D., and Susan E. Graf, RPh, MBA, to the Board of Directors.

Anticipated Milestones

• Initiation of the Phase 2 HONOR trial of ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025.​
• Initiation of the Phase 2 EMPOWER trial of ARD-201 for the treatment of obesity and obesity-related conditions as a fixed-dose combination of ARD-101 with a dipeptidyl peptidase-4 (DPP-4) inhibitor is expected in the second half of 2025.
• Topline data from the Phase 3 HERO trial for the treatment of hyperphagia associated with PWS is expected in early 2026.
  

Select Full Year 2024 Financial Highlights

• Cash Position: As of December 31, 2024, Aardvark had cash, cash equivalents, and short-term investments of $73.7 million, which does not include the proceeds from our IPO in February 2025. Based on current operating plans, Aardvark believes that our existing cash, cash equivalents, and short-term investments, together with the proceeds from our IPO, will be sufficient to fund projected operations into 2027.

• R&D Expenses: Research and development expenses were $17.4 million and $4.5 million for the year ended December 31, 2024 and 2023, respectively. The $12.9 million increase for the year ended December 31, 2024, resulted from increased development costs primarily related to ARD-101 and an increase in personnel-related expenses.

• G&A Expenses: G&A expenses were $5.3 million and $2.2 million for the year ended December 31, 2024, and 2023, respectively. The $3.1 million increase for the year ended December 31, 2024, primarily resulted from increases in personnel-related costs and other professional costs.

• Net loss: Net loss was $20.6 million and $7.2 million for the year ended December 31, 2024, and 2023, respectively.
  

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
Carolyn.hawley@inizioevoke.com

Aardvark Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
		Year Ended December 31,
		2024				2023
Operating expenses:
Research and development	$	17,363			$	4,480
General and administrative		5,305				2,173
Credit loss—related party accounts receivable		117				762
Total operating expenses		22,785				7,415
Loss from operations		(22,785	)			(7,415	)
Total other income, net		2,197				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		3,996,376				3,960,944

Aardvark Therapeutics, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts)
		December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents	$	61,641			$	9,735
Short-term investments		12,022				254
Prepaid expenses and other current assets		474				379
Total current assets		74,137				10,368
Operating lease right-of-use asset		735				155
Other assets		2,635				13
Total assets	$	77,507			$	10,536
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable	$	2,298			$	1,035
Accrued liabilities		2,291				235
Operating lease liability, current portion		338				112
Total current liabilities		4,927				1,382
Operating lease liability, net of current portion		441				50
Other long-term liabilities		26				2
Total liabilities		5,394				1,434
Commitments and contingencies
Convertible preferred stock		126,756				43,904
Stockholders’ deficit:
Common stock		-				-
Additional paid-in-capital		3,684				2,937
Accumulated deficit		(58,327	)			(37,739	)
Total stockholders’ deficit		(54,643	)			(34,802	)
Total liabilities, convertible preferred stock, and stockholders’ deficit	$	77,507			$	10,536

FAQ

What were the key findings from AARD's ARD-101 Phase 2 trial in Prader-Willi Syndrome?

ARD-101 showed up to 16-point HQ-CT reduction in hyperphagia (average 8 points), with DEXA scans showing ~1.5% decreased body fat and over 2% increased lean muscle during 28-day dosing.

How much did Aardvark Therapeutics (AARD) raise in its February 2025 IPO?

Aardvark raised $97.9 million in gross proceeds through its Initial Public Offering in February 2025.

What is AARD's cash runway following its 2024 results and IPO?

With $73.7 million cash position and IPO proceeds, Aardvark expects sufficient funding for operations into 2027.

When will AARD release topline data for the Phase 3 HERO trial?

Topline data from the Phase 3 HERO trial for hyperphagia in PWS is expected in early 2026.

What was Aardvark Therapeutics' (AARD) net loss for full year 2024?

AARD reported a net loss of $20.6 million for 2024, compared to $7.2 million in 2023.