Tempest Reports Second Quarter 2025 Financial Results and Provides Business Update
Tempest Therapeutics (NASDAQ: TPST) reported Q2 2025 financial results and significant clinical developments. The company received clearance for a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China, complementing existing FDA and EMA approvals. Amezalpat secured orphan drug designation from both the EMA and FDA, along with Fast Track designation for HCC treatment.
Financially, Tempest ended Q2 with $14.3 million in cash, down from $30.3 million in December 2024. The company reported a net loss of $7.9 million ($2.07 per share) and completed a $4.6 million registered direct offering in June 2025. The company is actively exploring strategic alternatives to maximize stockholder value while implementing cost-cutting measures.
Tempest Therapeutics (NASDAQ: TPST) ha pubblicato i risultati finanziari del secondo trimestre 2025 e annunciato importanti sviluppi clinici. L'azienda ha ottenuto l'autorizzazione per uno studio pivotal della terapia in combinazione con amezalpat come trattamento di prima linea per il carcinoma epatocellulare (HCC) in Cina, a complemento delle approvazioni già rilasciate da FDA ed EMA. Amezalpat ha inoltre ricevuto la designazione di farmaco orfano sia dall'EMA che dalla FDA, oltre alla designazione Fast Track per l'HCC.
Dal punto di vista finanziario, Tempest ha chiuso il 2° trimestre con 14,3 milioni di dollari in cassa, in calo rispetto ai 30,3 milioni di dicembre 2024. L'azienda ha registrato una perdita netta di 7,9 milioni di dollari (2,07 dollari per azione) e ha completato a giugno 2025 un offerta diretta registrata da 4,6 milioni di dollari. La società sta valutando attivamente alternative strategiche per massimizzare il valore per gli azionisti, mentre applica misure di contenimento dei costi.
Tempest Therapeutics (NASDAQ: TPST) informó los resultados financieros del segundo trimestre de 2025 y avances clínicos relevantes. La compañía obtuvo la autorización para un ensayo pivotal de la terapia combinada con amezalpat como primera línea para el carcinoma hepatocelular (HCC) en China, complementando las aprobaciones ya otorgadas por la FDA y la EMA. Amezalpat recibió la designación de medicamento huérfano tanto de la EMA como de la FDA, además de la designación Fast Track para el tratamiento del HCC.
En lo financiero, Tempest cerró el 2.º trimestre con 14,3 millones de dólares en efectivo, frente a 30,3 millones en diciembre de 2024. La compañía registró una pérdida neta de 7,9 millones de dólares (2,07 dólares por acción) y completó en junio de 2025 una oferta directa registrada por 4,6 millones de dólares. La empresa está explorando activamente alternativas estratégicas para maximizar el valor para los accionistas y, al mismo tiempo, aplica medidas de reducción de costos.
Tempest Therapeutics (NASDAQ: TPST)은 2025년 2분기 실적과 주요 임상 성과를 발표했습니다. 회사는 중국에서 1차 간세포암(HCC) 치료제로 amezalpat 병용요법의 결정적(pivotal) 임상시험 허가를 받았으며, 이는 기존의 FDA 및 EMA 승인에 더해진 것입니다. Amezalpat는 EMA와 FDA로부터 희귀의약품 지정을 받았고, HCC 치료에 대해 Fast Track 지정도 획득했습니다.
재무적으로 Tempest는 2분기 말에 현금 1,430만 달러를 보유했으며, 이는 2024년 12월의 3,030만 달러에서 감소한 수치입니다. 회사는 순손실 790만 달러(주당 2.07달러)를 기록했고, 2025년 6월에 460만 달러 규모의 등록 직접 공모를 완료했습니다. 회사는 주주 가치를 극대화하기 위해 전략적 대안을 적극 검토하는 한편 비용 절감 조치도 시행하고 있습니다.
Tempest Therapeutics (NASDAQ: TPST) a publié ses résultats financiers du deuxième trimestre 2025 et annoncé des avancées cliniques importantes. La société a obtenu l'autorisation d'un essai pivotal de la thérapie combinée à l'amezalpat en première intention pour le carcinome hépatocellulaire (HCC) en Chine, en complément des autorisations déjà accordées par la FDA et l'EMA. Amezalpat a reçu la désignation de médicament orphelin de l'EMA et de la FDA, ainsi que la désignation Fast Track pour le traitement du HCC.
Sur le plan financier, Tempest a clôturé le deuxième trimestre avec 14,3 millions de dollars de trésorerie, contre 30,3 millions en décembre 2024. La société a enregistré une perte nette de 7,9 millions de dollars (2,07 $ par action) et a finalisé en juin 2025 une offre directe enregistrée de 4,6 millions de dollars. L'entreprise étudie activement des alternatives stratégiques pour maximiser la valeur pour les actionnaires tout en mettant en œuvre des mesures de réduction des coûts.
Tempest Therapeutics (NASDAQ: TPST) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 sowie bedeutende klinische Entwicklungen. Das Unternehmen erhielt in China die Zulassung für eine pivotal Studie der amezalpat-Kombinationstherapie als Erstlinienbehandlung beim hepatozellulären Karzinom (HCC), ergänzend zu bestehenden Zulassungen durch FDA und EMA. Amezalpat erhielt sowohl von der EMA als auch von der FDA die Orphan-Drug-Zulassung sowie die Fast Track-Designation für die HCC-Behandlung.
Finanziell schloss Tempest das 2. Quartal mit 14,3 Mio. USD an liquiden Mitteln ab, gegenüber 30,3 Mio. USD im Dezember 2024. Das Unternehmen verzeichnete einen Nettoverlust von 7,9 Mio. USD (2,07 USD je Aktie) und schloss im Juni 2025 eine registrierte Direktplatzierung über 4,6 Mio. USD ab. Die Gesellschaft prüft aktiv strategische Alternativen zur Maximierung des Aktionärswerts und setzt gleichzeitig Kostensenkungsmaßnahmen um.
- Received clearance for pivotal trial of amezalpat in China, expanding global reach
- Secured both FDA and EMA orphan drug designations for amezalpat in HCC treatment
- Obtained FDA Fast Track designation for amezalpat
- Reduced quarterly net loss to $7.9M from $9.6M year-over-year
- Successfully raised $4.6M through registered direct offering
- Cash position decreased significantly to $14.3M from $30.3M in December 2024
- Implementing cost-cutting measures and exploring strategic alternatives, indicating potential financial strain
- Operating cash burn of $16.5M in first half of 2025
- Increased R&D expenses by $1.3M for first half of 2025 compared to 2024
Insights
Tempest advances cancer pipeline with pivotal trial clearances and orphan designations while pursuing strategic alternatives amid cash burn concerns.
Tempest Therapeutics has achieved several significant regulatory milestones for its lead cancer drug candidates, demonstrating continued clinical momentum despite financial challenges. The company received clearance in China to initiate a pivotal trial for amezalpat combination therapy in first-line hepatocellular carcinoma (HCC), complementing previous clearances in the US and Europe. This global regulatory alignment suggests strong confidence in amezalpat's potential.
The drug's orphan designations from both the FDA and EMA for HCC treatment are particularly valuable, offering benefits like market exclusivity, reduced fees, and potential accelerated approval pathways. Similarly, TPST-1495 received orphan designation for familial adenomatous polyposis, expanding Tempest's potential indications.
Mechanistically, amezalpat's dual action as a PPARα antagonist with immunomodulatory effects (as highlighted at AACR 2025) represents a novel approach to cancer treatment. This unique mechanism could differentiate it in the competitive oncology landscape if clinical efficacy matches preclinical promise.
However, these clinical advances are occurring against a backdrop of financial strain. The company's cash position decreased from $30.3 million in December 2024 to $14.3 million by Q2 2025, with a quarterly net loss of $7.9 million. The announced cost-cutting measures and exploration of strategic alternatives signal management's recognition that additional funding or partnerships will be necessary to advance their promising pipeline through costly late-stage trials.
Despite regulatory progress, Tempest faces critical cash runway challenges with $14.3M remaining and quarterly burn rate around $8M.
Tempest's financial situation warrants close attention despite its clinical progress. The company reported
While management has implemented cost-cutting measures, including staff reductions (evidenced by one-time separation costs), R&D expenses for Q2 decreased by
The company has attempted to extend its runway through a
The explicit mention of "exploring strategic alternatives to maximize stockholder value" signals that management is actively seeking acquisition, merger, or significant partnership opportunities. Given the promising regulatory designations secured for both clinical candidates but limited financial resources, a transaction appears increasingly necessary for the company to realize the potential value of its pipeline.
- Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China
- Granted orphan drug designation from the European Medicines Agency (EMA) for amezalpat for the treatment of patients with HCC
- 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)
BRISBANE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended June 30, 2025 and provided a corporate update.
“We are pleased to see the continued progress of our clinical oncology portfolio, including the recent clearance in China to initiate a pivotal trial of amezalpat combination therapy in first-line HCC, expanding on similar clearances we received in the U.S. and Europe from the FDA and EMA,” said Stephen Brady, president and chief executive officer of Tempest. “We believe these milestones reflect both the promise of our therapies and the dedication of the team who brought the programs to this point. We remain actively engaged in our strategic alternatives process with the goal of maximizing value for stockholders and patients.”
____________________
1 If approved by the U.S. Food and Drug Administration (FDA).
Recent Highlights
- Amezalpat (TPST-1120) (clinical PPARα antagonist):
- Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line HCC in China.
- Granted orphan drug designation from the EMA for amezalpat for the treatment of patients with HCC.
- 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.
- Corporate:
- Announced cost-cutting measures and plans to explore a full range of strategic alternatives to advance the company’s promising clinical-stage programs and maximize stockholder value.
- Strengthened cash position with completion of
$4.6 million registered direct offering of common stock in June 2025.
Financial Results
Second Quarter 2025
- Tempest ended the quarter with
$14.3 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$4.1 million in net proceeds from the June 2025 registered direct offering, as well as$2.8 million in net proceeds from the company’s at-the-market offering program. - Net loss and net loss per share for the quarter were
$7.9 million and$2.07 , respectively, compared to$9.6 million and$5.52 , respectively, for the same period in 2024. - Research and development expenses for the quarter were
$3.9 million , compared to$5.8 million for the same period in 2024. The$1.9 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives. - General and administrative expenses for the quarter were
$4.1 million , compared to$3.7 million for the same period in 2024. The$0.4 million increase was primarily related to one-time separations costs for employees terminated during the period.
Year-to-Date
- Cash used in operating activities for the six months ended June 30, 2025 was
$16.5 million . - Net loss and net loss per share for the six months ended June 30, 2025 were
$18.7 million and$5.17 , respectively, compared to$17.5 million and$10.15 , respectively, for the same period in 2024. - Research and development expenses for the six months ended June 30, 2025 were
$11.5 million , compared to$10.2 million for the same period in 2024. The$1.3 million increase was primarily due to an increase in costs incurred from contract research and manufacturing organizations in preparation for the company’s pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC. - General and administrative expenses for the six months ended June 30, 2025 were
$7.4 million , compared to$7.4 million for the same period in 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the quarter ended June 30, 2025, as well as consulting, professional services and facilities costs.
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 value for stockholders and patients 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and other documents filed by the Company from time to time with the Securities and Exchange Commission. 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) | |||||||
| June 30, 2025 | December 31, 2024 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 14,280 | $ | 30,268 | |||
| Prepaid expenses and other current assets | 823 | 1,206 | |||||
| Total current assets | 15,103 | 31,474 | |||||
| Property and equipment, net | 748 | 886 | |||||
| Operating lease right-of-use assets | 8,104 | 8,643 | |||||
| Other noncurrent assets | 529 | 485 | |||||
| Total assets | $ | 24,484 | $ | 41,488 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 4,716 | $ | 2,450 | |||
| Accrued expenses | 1,221 | 2,726 | |||||
| Current loan payable, net | - | 6,354 | |||||
| Current operating lease liabilities | 1,103 | 869 | |||||
| Accrued compensation | 101 | 1,762 | |||||
| Interest payable | - | 59 | |||||
| Total current liabilities | 7,141 | 14,220 | |||||
| Operating lease liabilities | 7,560 | 8,142 | |||||
| Total liabilities | 14,701 | 22,362 | |||||
| Stockholders' equity | |||||||
| Common stock(1) | 4 | 3 | |||||
| Additional paid-in capital(1) | 235,615 | 226,229 | |||||
| Accumulated deficit | (225,836 | ) | (207,106 | ) | |||
| Total stockholders' equity | 9,783 | 19,126 | |||||
| Total liabilities and stockholders' equity | $ | 24,484 | $ | 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 | Six months ended | Six months ended | ||||||||||||
| June 30, 2025 | June 30, 2024 | June 30, 2025 | June 30, 2024 | ||||||||||||
| Expenses: | |||||||||||||||
| Research and development | $ | 3,871 | $ | 5,837 | $ | 11,498 | $ | 10,177 | |||||||
| General and administrative | 4,095 | 3,745 | 7,404 | 7,379 | |||||||||||
| Operating loss | (7,966 | ) | (9,582 | ) | (18,902 | ) | (17,556 | ) | |||||||
| Other income (expense), net: | |||||||||||||||
| Interest expense | (46 | ) | (372 | ) | (207 | ) | (740 | ) | |||||||
| Interest and other income, net | 142 | 384 | 379 | 822 | |||||||||||
| Net loss | $ | (7,870 | ) | $ | (9,570 | ) | $ | (18,730 | ) | $ | (17,474 | ) | |||
| Net loss per share(1) | $ | (2.07 | ) | $ | (5.52 | ) | $ | (5.17 | ) | $ | (10.15 | ) | |||
(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
____________________
i If approved by the FDA
FAQ
What regulatory designations did Tempest's amezalpat receive in Q2 2025?
How much cash does Tempest (TPST) have as of Q2 2025?
What was Tempest Therapeutics' net loss in Q2 2025?
What major clinical trial advancement did TPST achieve in China?
How much capital did Tempest raise in their June 2025 offering?
