Tempest Reports First Quarter 2025 Financial Results and Provides Business Update

Rhea-AI Summary

Tempest Therapeutics (NASDAQ: TPST) reported Q1 2025 financial results and corporate updates. The company presented new data for amezalpat at AACR, demonstrating its potential in cancer treatment by reducing immunosuppression. Key developments include: FDA granting both Orphan Drug and Fast Track designations for amezalpat in hepatocellular carcinoma (HCC) treatment, and Orphan Drug designation for TPST-1495 in familial adenomatous polyposis (FAP). Financially, Tempest ended Q1 with $21.5 million in cash, down from $30.3 million in December 2024. The company reported a net loss of $10.9 million ($3.16 per share) compared to $7.9 million in Q1 2024. R&D expenses increased to $7.6 million, primarily due to preparation for amezalpat's Phase 3 trial. The company announced plans to explore strategic alternatives and completed a workforce reduction in April 2025.

Positive

• FDA granted both Orphan Drug and Fast Track designations for amezalpat in HCC treatment
• New data at AACR showed positive results for amezalpat's mechanism of action in cancer treatment
• FDA granted Orphan Drug designation for TPST-1495 in FAP treatment
• Received FDA 'Study May Proceed' letter for Phase 2 trial of TPST-1495
• Repaid $3.5 million loan to Oxford Finance LLC, reducing debt obligations

Negative

• Net loss increased to $10.9 million in Q1 2025 from $7.9 million in Q1 2024
• Cash position decreased to $21.5 million from $30.3 million in December 2024
• R&D expenses increased significantly to $7.6 million from $4.3 million year-over-year
• Company implemented workforce reduction in April 2025
• Exploring strategic alternatives, suggesting potential financial or operational challenges

Insights

Biotech Industry Analyst

Tempest's regulatory wins and positive amezalpat data are promising, but strategic alternatives exploration signals financial constraints.

Tempest's Q1 update reveals multiple positive regulatory milestones that enhance their clinical-stage oncology pipeline. The FDA granted both Orphan Drug and Fast Track designations for amezalpat in hepatocellular carcinoma (HCC), and Orphan Drug designation for TPST-1495 in familial adenomatous polyposis (FAP). These designations provide potential benefits including tax credits, extended market exclusivity, and expedited review pathways.

The new mechanistic data presented at AACR showing amezalpat reduces immunosuppression and activates anti-tumor immune responses supports its dual mechanism of action. This reinforces the positive randomized Phase 2 results previously reported and strengthens the scientific rationale for its development in HCC, where therapeutic options remain limited.

However, there are concerning financial signals. The $8.8 million cash burn in Q1 (from $30.3 million to $21.5 million) gives them approximately 7-8 months of runway at current spending levels. The announced reduction in workforce and exploration of "strategic alternatives" are typical euphemisms for financial pressure. The company's $10.9 million quarterly net loss widened compared to $7.9 million in the same period of 2024, and R&D expenses increased by $3.3 million as they prepare for a pivotal Phase 3 trial.

The repayment of the $3.5 million Oxford Finance loan removes debt obligations but further depletes cash reserves. Given the preparations for a costly Phase 3 trial and limited cash, a partnership, acquisition, or significant financing appears necessary in the near term for Tempest to advance its promising clinical candidates.

• Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual Meeting
• Granted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP)
• Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of FAP
• Granted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the treatment of patients with hepatocellular carcinoma (HCC)

BRISBANE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class¹ targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended March 31, 2025 and provided a corporate update.

“The amezalpat program continues to produce data that reinforce its potential as a cancer therapy, most recently in a presentation at AACR showing that amezalpat reduced immunosuppression and activated the immune system to attack tumors. We were pleased to present these data that elucidate one part of the amezalpat mechanism of action and support the positive randomized Phase 2 data, including the benefit seen in patients with markers of immune resistance,” said Stephen Brady, president and chief executive officer of Tempest. “We are actively engaged in exploring strategic alternatives to advance our promising clinical-stage programs and maximize stockholder value and, given the data, continue to have strong conviction in the potential of our oncology portfolio to drive meaningful impact for patients facing cancer.”

________________
¹ If approved by the U.S. Food and Drug Administration (FDA).

Recent Highlights

• Amezalpat (TPST-1120) (clinical PPARα antagonist):
  • Reported new data at the 2025 American Association for Cancer Research (AACR) Annual Meeting supporting the immune component of amezalpat’s dual mechanism of action and reinforcing its potential as a novel cancer treatment.
  • Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC.
• TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist):
  • Granted Orphan Drug designation by the FDA to treat patients with FAP.
  • Received a “Study May Proceed” letter from the FDA for the Phase 2 trial for the treatment of FAP.
  • This trial, run by CP-CTNet and financially supported by the NCI’s Division of Cancer Prevention, underscores the urgent need for innovative cancer prevention strategies in high-risk patient populations. The Phase 2 study is expected to begin in 2025.
• Corporate:
  • Announced (i) plans to explore a full range of strategic alternatives to advance the company’s promising clinical-stage programs and maximize stockholder value and (ii) a reduction in force that was completed on April 30, 2025.
  • Using cash on hand, the company repaid $3.5 million in full satisfaction of Loan and Security Agreement with Oxford Finance LLC in April 2025.
    
    

Financial Results

First Quarter 2025

• Tempest ended the quarter with $21.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by proceeds of $1.5 million from the at-the-market offering program.
• Net loss and net loss per share for the quarter were $10.9 million and $3.16, respectively, compared to $7.9 million and $4.62, respectively, for the same period in 2024.
• Research and development expenses for the quarter were $7.6 million compared to $4.3 million for the same period in 2024. The $3.3 million increase was primarily due to an increase in costs incurred from engaging contract research and manufacturing organizations in preparation for our pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC.
• General and administrative expenses for the quarter were $3.3 million compared to $3.6 million for the same period in 2024. The $0.3 million decrease was primarily due to a decrease in consulting services.
  
  

About Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biotechnology company advancing a diverse portfolio of small molecule product candidates containing tumor-targeted and/or immune-mediated mechanisms with the potential to treat a wide range of tumors. The company’s novel programs range from early research to later-stage investigation in a randomized global study in first-line cancer patients. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at www.tempesttx.com.

Forward-Looking Statements

This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements contained in this press release include but are not limited to statements relating to Tempest Therapeutics’ evaluation of strategic alternatives available to the company to maximize stockholder value and anticipated therapeutic benefit and regulatory development of Tempest Therapeutic’ product candidates. Any forward-looking statements in this press release are based on Tempest Therapeutics’ current expectations, estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks relating to volatility and uncertainty in the capital markets for biotechnology companies; Tempest Therapeutics’ ability to continue to operate as a going concern; availability of suitable third parties with which to conduct contemplated strategic transactions; whether we will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed on attractive terms or at all; unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and unexpected litigation or other disputes. These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 27, 2025, as well as in other filings the company may make with the SEC in the future. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.

TEMPEST THERAPEUTICS, INC.
Consolidated Balance Sheets
(in thousands)
	March 31, 2025				December 31, 2024
Assets
Current assets
Cash and cash equivalents	$	21,511			$	30,268
Prepaid expenses and other current assets		922				1,206
Total current assets		22,433				31,474
Property and equipment, net		817				886
Operating lease right-of-use assets		8,376				8,643
Other noncurrent assets		538				485
Total assets	$	32,164			$	41,488
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable	$	2,187			$	2,450
Accrued expenses		4,985				2,726
Current loan payable, net		4,190				6,354
Current operating lease liabilities		1,061				869
Accrued compensation		718				1,762
Interest payable		36				59
Total current liabilities		13,177				14,220
Operating lease liabilities		7,854				8,142
Total liabilities		21,031				22,362
Stockholders' equity
Common stock(1)		4				3
Additional paid-in capital(1)		229,095				226,229
Accumulated deficit		(217,966	)			(207,106	)
Total stockholders' equity		11,133				19,126
Total liabilities and stockholders' equity	$	32,164			$	41,488

⁽¹⁾ Results have been adjusted to reflect the one-for-thirteen reverse stock split effected in April 2025.

TEMPEST THERAPEUTICS, INC.
Consolidated Statements of Operations
(in thousands, except per share amounts)
	Three months ended				Three months ended
	March 31, 2025				March 31, 2024
Expenses:
Research and development	$	7,627			$	4,340
General and administrative		3,309				3,634
Operating loss		(10,936	)			(7,974	)
Other income (expense), net:
Interest expense		(161	)			(368	)
Interest and other income, net		237				438
Net loss	$	(10,860	)		$	(7,904	)
Net loss per share(1)	$	(3.16	)		$	(4.62	)

⁽¹⁾ Results have been adjusted to reflect the one-for-thirteen reverse stock split effected in April 2025.

Investor Contacts:

Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com

Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com

FAQ

What are the recent FDA designations received by Tempest Therapeutics (TPST) for amezalpat?

In Q1 2025, Tempest Therapeutics received both Orphan Drug and Fast Track designations from the FDA for amezalpat for the treatment of patients with hepatocellular carcinoma (HCC).

How much cash does Tempest Therapeutics (TPST) have as of Q1 2025?

Tempest Therapeutics ended Q1 2025 with $21.5 million in cash and cash equivalents, down from $30.3 million at the end of December 2024.

What was TPST's net loss per share in Q1 2025?

Tempest Therapeutics reported a net loss of $3.16 per share in Q1 2025, compared to $4.62 per share in Q1 2024.

What new data did Tempest present at AACR 2025 for amezalpat?

At AACR 2025, Tempest presented new data showing that amezalpat reduced immunosuppression and activated the immune system to attack tumors, supporting its potential as a novel cancer treatment.

What strategic changes did Tempest Therapeutics announce in Q1 2025?

Tempest announced plans to explore strategic alternatives to advance their clinical-stage programs and maximize stockholder value, and implemented a workforce reduction that was completed on April 30, 2025.