Tempest Reports Year End 2024 Financial Results and Provides Business Update
Tempest Therapeutics (NASDAQ: TPST) reported significant progress in 2024, highlighted by key developments for their cancer therapeutics. Their lead drug Amezalpat received both Orphan Drug and Fast Track designations from the FDA for Hepatocellular Carcinoma (HCC) treatment. The company secured an agreement with Roche to advance Amezalpat into a Phase 3 trial.
Clinical results showed Amezalpat delivered a six-month improvement in median overall survival when combined with standard treatments for HCC. For TPST-1495, the company received FDA clearance for a Phase 2 trial in Familial Adenomatous Polyposis.
Financial results showed cash position of $30.3 million at year-end, down from $39.2 million in 2023. Net loss increased to $41.8 million ($1.50 per share) compared to $29.5 million ($1.91 per share) in 2023. R&D expenses rose to $28.5 million from $17.5 million, while G&A expenses increased to $13.6 million from $11.7 million.
Tempest Therapeutics (NASDAQ: TPST) ha riportato progressi significativi nel 2024, evidenziati da sviluppi chiave per le loro terapie oncologiche. Il loro farmaco principale, Amezalpat, ha ricevuto sia la designazione di Farmaco Orfano che quella di Fast Track dalla FDA per il trattamento del Carcinoma Epatocellulare (HCC). L'azienda ha stipulato un accordo con Roche per portare Amezalpat in una sperimentazione di Fase 3.
I risultati clinici hanno mostrato che Amezalpat ha fornito un miglioramento di sei mesi nella sopravvivenza globale mediana quando combinato con trattamenti standard per l'HCC. Per TPST-1495, l'azienda ha ricevuto l'approvazione della FDA per una sperimentazione di Fase 2 nella Poliposi Adenomatosa Familiare.
I risultati finanziari hanno mostrato una posizione di cassa di 30,3 milioni di dollari a fine anno, in calo rispetto ai 39,2 milioni di dollari nel 2023. La perdita netta è aumentata a 41,8 milioni di dollari (1,50 dollari per azione) rispetto ai 29,5 milioni di dollari (1,91 dollari per azione) nel 2023. Le spese per R&S sono aumentate a 28,5 milioni di dollari rispetto ai 17,5 milioni, mentre le spese generali e amministrative sono aumentate a 13,6 milioni di dollari rispetto agli 11,7 milioni.
Tempest Therapeutics (NASDAQ: TPST) informó sobre avances significativos en 2024, resaltando desarrollos clave para sus terapias contra el cáncer. Su medicamento principal, Amezalpat, recibió tanto la designación de Medicamento Huérfano como la de Vía Rápida de la FDA para el tratamiento del Carcinoma Hepatocelular (HCC). La empresa aseguró un acuerdo con Roche para avanzar Amezalpat a un ensayo de Fase 3.
Los resultados clínicos mostraron que Amezalpat proporcionó una mejora de seis meses en la supervivencia global media cuando se combinó con tratamientos estándar para el HCC. Para TPST-1495, la empresa recibió la autorización de la FDA para un ensayo de Fase 2 en Poliposis Adenomatosa Familiar.
Los resultados financieros mostraron una posición de efectivo de 30,3 millones de dólares al final del año, en comparación con los 39,2 millones de dólares en 2023. La pérdida neta aumentó a 41,8 millones de dólares (1,50 dólares por acción) en comparación con los 29,5 millones de dólares (1,91 dólares por acción) en 2023. Los gastos de I+D aumentaron a 28,5 millones de dólares desde 17,5 millones, mientras que los gastos generales y administrativos aumentaron a 13,6 millones de dólares desde 11,7 millones.
템페스트 테라퓨틱스 (NASDAQ: TPST)는 2024년에 중요한 진전을 보고하며, 암 치료를 위한 주요 개발 사항을 강조했습니다. 그들의 주요 약물인 아메잘파트는 간세포암(HCC) 치료를 위해 FDA로부터 희귀의약품 및 신속 심사 지정을 받았습니다. 이 회사는 아메잘파트를 3상 임상시험으로 진행하기 위해 로슈와 계약을 체결했습니다.
임상 결과에 따르면 아메잘파트는 HCC에 대한 표준 치료와 병용했을 때 중앙 전체 생존 기간을 6개월 개선한 것으로 나타났습니다. TPST-1495의 경우, 이 회사는 가족성 선종성 용종증에 대한 2상 임상시험을 위한 FDA 승인을 받았습니다.
재무 결과에 따르면 연말 현금 보유액은 3,030만 달러로, 2023년의 3,920만 달러에서 감소했습니다. 순손실은 4,180만 달러(주당 1.50달러)로 증가했으며, 이는 2023년의 2,950만 달러(주당 1.91달러)와 비교됩니다. 연구개발 비용은 1,750만 달러에서 2,850만 달러로 증가했으며, 일반관리비는 1,170만 달러에서 1,360만 달러로 증가했습니다.
Tempest Therapeutics (NASDAQ: TPST) a rapporté des progrès significatifs en 2024, soulignés par des développements clés pour leurs thérapies contre le cancer. Leur médicament phare, Amezalpat, a reçu à la fois les désignations de Médicament Orphelin et de Voie Rapide de la FDA pour le traitement du Carcinome Hépatocellulaire (HCC). L'entreprise a conclu un accord avec Roche pour faire avancer Amezalpat dans un essai de Phase 3.
Les résultats cliniques ont montré qu'Amezalpat a permis une amélioration de six mois de la survie globale médiane lorsqu'il est associé à des traitements standards pour le HCC. Pour TPST-1495, l'entreprise a reçu l'approbation de la FDA pour un essai de Phase 2 dans la Polypose Adenomateuse Familiale.
Les résultats financiers ont montré une position de trésorerie de 30,3 millions de dollars à la fin de l'année, en baisse par rapport à 39,2 millions de dollars en 2023. La perte nette a augmenté à 41,8 millions de dollars (1,50 dollar par action) par rapport à 29,5 millions de dollars (1,91 dollar par action) en 2023. Les dépenses de R&D ont augmenté à 28,5 millions de dollars contre 17,5 millions, tandis que les dépenses générales et administratives ont augmenté à 13,6 millions de dollars contre 11,7 millions.
Tempest Therapeutics (NASDAQ: TPST) berichtete über bedeutende Fortschritte im Jahr 2024, die durch wichtige Entwicklungen für ihre Krebstherapien hervorgehoben wurden. Ihr Hauptmedikament Amezalpat erhielt sowohl die Orphan Drug- als auch die Fast Track-Designationen von der FDA zur Behandlung des hepatozellulären Karzinoms (HCC). Das Unternehmen sicherte sich eine Vereinbarung mit Roche, um Amezalpat in eine Phase-3-Studie voranzutreiben.
Klinische Ergebnisse zeigten, dass Amezalpat eine Verbesserung der medianen Gesamtüberlebenszeit um sechs Monate erzielte, als es mit Standardbehandlungen für HCC kombiniert wurde. Für TPST-1495 erhielt das Unternehmen die Genehmigung der FDA für eine Phase-2-Studie bei familiärer adenomatöser Polyposis.
Die finanziellen Ergebnisse zeigten eine Barreserven von 30,3 Millionen Dollar zum Jahresende, ein Rückgang von 39,2 Millionen Dollar im Jahr 2023. Der Nettoverlust stieg auf 41,8 Millionen Dollar (1,50 Dollar pro Aktie) im Vergleich zu 29,5 Millionen Dollar (1,91 Dollar pro Aktie) im Jahr 2023. Die F&E-Ausgaben stiegen auf 28,5 Millionen Dollar von 17,5 Millionen Dollar, während die allgemeinen und administrativen Ausgaben auf 13,6 Millionen Dollar von 11,7 Millionen Dollar stiegen.
- Amezalpat achieved both Orphan Drug and Fast Track FDA designations for HCC treatment
- Secured partnership with Roche for Phase 3 trial advancement
- Clinical data showed 6-month improvement in median overall survival for Amezalpat combination therapy
- Raised $28.6 million through ATM offering program
- Net loss increased 41.7% to $41.8 million in 2024
- R&D expenses increased 62.9% to $28.5 million
- Cash position decreased by $8.9 million to $30.3 million
- G&A expenses rose 16.2% to $13.6 million
Insights
Tempest Therapeutics' 2024 financial results reveal a mixed financial picture alongside significant clinical advancements. The company ended with
The clinical progress is where Tempest delivers substantial value. Their lead candidate amezalpat received both Orphan Drug and Fast Track designations from the FDA for hepatocellular carcinoma (HCC), potentially accelerating its regulatory pathway. The reported six-month improvement in median overall survival when combined with standard-of-care therapy is clinically meaningful in this difficult-to-treat cancer.
The strategic agreement with Roche represents significant external validation, providing support for advancing amezalpat into a pivotal Phase 3 trial. Meanwhile, their second program (TPST-1495) is advancing to Phase 2 for Familial Adenomatous Polyposis with NCI funding, reducing financial burden.
Despite raising
• Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma (HCC)
• Announced Agreement with Roche to Support Advancement of Amezalpat Combination Therapy into First-Line HCC Pivotal Trial
• Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of Familial Adenomatous Polyposis (FAP)
BRISBANE, Calif., March 27, 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 year ended 2024 and provided a corporate update.
“2024 was another year filled with significant progress and milestone achievements that position Tempest for a successful future,” said Stephen Brady, president and chief executive officer of Tempest. “Despite challenging capital markets, our lean team excelled, reporting key OS data from the ongoing randomized Phase 2 trial of amezalpat in first-line hepatocellular carcinoma. As previously announced, we have secured broad regulatory agreement with both the FDA and EMA on the Phase 3 plan and received both Orphan Drug and Fast Track designations from the FDA. We also advanced our second clinical program, TPST-1495, with a Phase 2 clinical trial for the treatment of patients with FAP, with data expected in 2026. Our focus remains on execution with excellence while securing the resources necessary to drive these promising drug candidates forward.”
2024 & Recent Accomplishments
Amezalpat (TPST-1120) (clinical PPARα antagonist):
- 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.
- Received a “Study May Proceed” letter from the FDA to evaluate amezalpat in combination with atezolizumab (TECENTRIQ®) and bevacizumab (Avastin®), the current standard of care for unresectable or metastatic HCC, in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
- Announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
- Announced positive feedback from the end-of-Phase 2 meeting with the FDA for amezalpat in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic HCC.
- Reported new positive survival data from the ongoing global randomized Phase 1b/2 clinical study demonstrating that amezalpat delivered a six-month improvement in median overall survival (OS) when combined with atezolizumab and bevacizumab in comparison to atezolizumab and bevacizumab alone, the standard of care, in the first-line treatment of patients with unresectable or metastatic HCC.
- Published positive data from Phase 1 trial of amezalpat in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that amezalpat demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers. These data complement the positive Phase 1b/2 data reported in October 2023 and June 2024 from a global randomized study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
- Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting demonstrating that amezalpat reduces kidney cancer growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy. These data further support the clinical benefit observed in the amezalpat Phase 1 data presented in an oral presentation at ASCO 2022.
- TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
- Received a “Study May Proceed” letter from the FDA to evaluate TPST-1495 in a Phase 2 Trial for the treatment of FAP.
- Corporate:
- Expanded leadership team to strengthen global clinical expertise with the appointments of Troy M. Wagner as Vice President of Quality Assurance and Sheldon Mullins as Vice President of Regulatory Affairs.
Potential Future Milestones
- Amezalpat (TPST-1120) (clinical PPARα antagonist)
- Plan to advance amezalpat into a registrational study in first-line liver cancer patients, subject to obtaining additional resources.
- TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
- Plan to advance TPST-1495 into a Phase 2 study in patients with FAP under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention in 2025, with data expected in 2026.
Financial Results
Year End 2024
- Tempest ended the year with
$30.3 million in cash and cash equivalents, compared to$39.2 million on December 31, 2023. The decrease was primarily due to cash used in operating activities, offset by proceeds from the issuance of common stock of$28.6 million from the at-the-market offering program. - Net loss and net loss per share for the year were
$41.8 million and$1.50 , respectively, compared to$29.5 million and$1.91 , respectively, for the same period in 2023. - Research and development expenses for the year were
$28.5 million compared to$17.5 million for the same period in 2023. The$11.0 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 year were
$13.6 million compared to$11.7 million for the same period in 2023. The$1.9 million increase was primarily due to an increase in stock-based compensation expense due to increased headcount as well as an increase in expenses related to legal and 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 generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions. All statements that are not historical facts are forward-looking statements, including any statements regarding: the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat and Phase 2 Trial of TPST-1495; anticipated therapeutic benefit and regulatory development of the Company’s product candidates; the Company’s ability to advance into a late-stage clinical company; the Company’s ability to secure resources and funding; and the Company’s ability to achieve its operational plans. Forward-looking statements are based on information available to Tempest Therapeutics as of the date hereof and are not guarantees of future performance. Any factors may cause differences between current expectations and actual results, including: 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. 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 September 30, 2024 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) | |||||||
| December 31, 2024 | December 31, 2023 | ||||||
| Assets | |||||||
| Current assets | |||||||
| Cash and cash equivalents | $ | 30,268 | $ | 39,230 | |||
| Prepaid expenses and other current assets | 1,206 | 1,133 | |||||
| Total current assets | 31,474 | 40,363 | |||||
| Property and equipment, net | 886 | 840 | |||||
| Operating lease right-of-use assets | 8,643 | 9,952 | |||||
| Other noncurrent assets | 485 | 448 | |||||
| Total assets | $ | 41,488 | $ | 51,603 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities | |||||||
| Accounts payable | $ | 2,450 | $ | 845 | |||
| Accrued expenses and other | 2,726 | 1,673 | |||||
| Current loan payable, net | 6,354 | 4,285 | |||||
| Current operating lease liabilities | 869 | 952 | |||||
| Accrued compensation | 1,762 | 1,543 | |||||
| Interest payable | 59 | 113 | |||||
| Total current liabilities | 14,220 | 9,411 | |||||
| Loan payable, net | - | 6,264 | |||||
| Operating lease liabilities | 8,142 | 9,160 | |||||
| Total liabilities | 22,362 | 24,835 | |||||
| Stockholders' equity | |||||||
| Common stock | 44 | 22 | |||||
| Additional paid-in capital | 226,188 | 192,009 | |||||
| Accumulated deficit | (207,106) | (165,263) | |||||
| Total stockholders' equity | 19,126 | 26,768 | |||||
| Total liabilities and stockholders' equity | $ | 41,488 | $ | 51,603 | |||
| TEMPEST THERAPEUTICS, INC. | |||||||
| Consolidated Statements of Operations | |||||||
| (in thousands, except per share amounts) | |||||||
| Year ended | Year ended | ||||||
| December 31, 2024 | December 31, 2023 | ||||||
| Expenses: | |||||||
| Research and development | $ | 28,476 | $ | 17,498 | |||
| General and administrative | 13,550 | 11,659 | |||||
| Operating loss | (42,026) | (29,157) | |||||
| Other income (expense), net: | |||||||
| Interest expense | (1,316) | (1,449) | |||||
| Interest and other income, net | 1,499 | 1,115 | |||||
| Net loss | $ | (41,843) | $ | (29,491) | |||
| Net loss per share | $ | (1.50) | $ | (1.91) | |||
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
1 If approved by the U.S. Food and Drug Administration (FDA).
FAQ
What were the key clinical results for TPST's Amezalpat in HCC treatment?
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