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Tempest Reports Third Quarter 2024 Financial Results and Provides Business Update

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Tempest Therapeutics (NASDAQ: TPST) reported Q3 2024 financial results and key developments. The company received FDA's 'Study May Proceed' letter for a pivotal Phase 3 trial of amezalpat combination therapy for first-line HCC treatment. Tempest announced an agreement with Roche to support amezalpat's advancement and received NCI funding approval for TPST-1495 Phase 2 trial in FAP.

Financial highlights include: Q3 cash position of $22.1M, net loss of $10.6M ($0.41 per share), and R&D expenses of $7.6M. The company raised additional $19.9M through ATM offering post-quarter. Year-to-date operating cash burn was $22.9M with a net loss of $28.0M ($1.19 per share).

Tempest Therapeutics (NASDAQ: TPST) ha riportato i risultati finanziari del terzo trimestre 2024 e sviluppi chiave. L'azienda ha ricevuto la lettera 'Study May Proceed' dalla FDA per un trial clinico di fase 3 cruciale della terapia combinata amezalpat per il trattamento di prima linea dell'HCC. Tempest ha annunciato un accordo con Roche per supportare l'avanzamento dell'amezalpat e ha ricevuto l'approvazione per il finanziamento NCI per il trial di fase 2 di TPST-1495 in FAP.

I punti salienti finanziari includono: una posizione di cassa di $22.1 milioni nel terzo trimestre, una perdita netta di $10.6 milioni ($0.41 per azione) e spese per R&D di $7.6 milioni. L'azienda ha raccolto ulteriori $19.9 milioni tramite un'offerta ATM dopo il trimestre. Fino ad oggi, il burn di cassa operativo è stato di $22.9 milioni con una perdita netta di $28.0 milioni ($1.19 per azione).

Tempest Therapeutics (NASDAQ: TPST) reportó los resultados financieros del tercer trimestre de 2024 y desarrollos clave. La compañía recibió la carta 'Study May Proceed' de la FDA para un ensayo clínico pivotal de fase 3 de la terapia combinada amezalpat para el tratamiento de HCC de primera línea. Tempest anunció un acuerdo con Roche para apoyar el avance del amezalpat y recibió la aprobación de financiamiento del NCI para el ensayo de fase 2 de TPST-1495 en FAP.

Los aspectos financieros destacados incluyen: una posición de efectivo de $22.1 millones en el tercer trimestre, una pérdida neta de $10.6 millones ($0.41 por acción) y gastos de I+D de $7.6 millones. La compañía recaudó $19.9 millones adicionales a través de una oferta ATM después del trimestre. Hasta la fecha, el consumo de efectivo operativo fue de $22.9 millones con una pérdida neta de $28.0 millones ($1.19 por acción).

템페스트 테라퓨틱스 (NASDAQ: TPST)는 2024년 3분기 재무 결과 및 주요 개발 사항을 보고했습니다. 회사는 첫 번째 라인의 HCC 치료를 위한 아메잘파트 병용 요법에 대한 중요한 3상 시험을 위한 FDA의 'Study May Proceed' 서한을 받았습니다. 템페스트는 아메잘파트의 발전을 지원하기 위해 로슈와 계약을 체결했으며, FAP에 대한 TPST-1495 2상 시험에 대한 NCI 자금 승인을 받았습니다.

재무 하이라이트에는 3분기 현금 위치가 $22.1M, 순손실이 $10.6M ($0.41 주당) 그리고 R&D 비용이 $7.6M이 포함됩니다. 회사는 분기 후 ATM 공모를 통해 추가로 $19.9M을 조달했습니다. 연초부터 현재까지 운영 현금 소모는 $22.9M, 순손실은 $28.0M ($1.19 주당)으로 나타났습니다.

Tempest Therapeutics (NASDAQ: TPST) a rapporté les résultats financiers du troisième trimestre 2024 et des développements clés. L'entreprise a reçu la lettre 'Study May Proceed' de la FDA pour un essai clinique pivot de phase 3 de la thérapie combinée amezalpat pour le traitement du HCC en première ligne. Tempest a annoncé un accord avec Roche pour soutenir l'avancement de l'amezalpat et a obtenu l'approbation du financement du NCI pour l'essai de phase 2 de TPST-1495 en FAP.

Les points forts financiers incluent : une position de trésorerie de 22,1 millions de dollars au troisième trimestre, une perte nette de 10,6 millions de dollars (0,41 $ par action) et des dépenses de R&D de 7,6 millions de dollars. L'entreprise a levé 19,9 millions de dollars supplémentaires par le biais d'une offre ATM après le trimestre. Depuis le début de l'année, la consommation de liquidités opérationnelles a été de 22,9 millions de dollars avec une perte nette de 28,0 millions de dollars (1,19 $ par action).

Tempest Therapeutics (NASDAQ: TPST) hat die Finanzergebnisse für das 3. Quartal 2024 und wichtige Entwicklungen gemeldet. Das Unternehmen erhielt den 'Study May Proceed'-Brief der FDA für eine entscheidende Phase-3-Studie zur Kombinationstherapie mit Amezalpat für die Erstlinienbehandlung von HCC. Tempest gab eine Vereinbarung mit Roche bekannt, um den Fortschritt von Amezalpat zu unterstützen, und erhielt die Genehmigung für die NCI-Finanzierung für die Phase-2-Studie von TPST-1495 in FAP.

Zu den finanziellen Highlights gehören: eine Kassenposition von 22,1 Millionen US-Dollar im 3. Quartal, ein Nettoverlust von 10,6 Millionen US-Dollar (0,41 US-Dollar pro Aktie) und F&E-Ausgaben von 7,6 Millionen US-Dollar. Das Unternehmen hat nach dem Quartal weitere 19,9 Millionen US-Dollar über ein ATM-Angebot aufgenommen. Der Betriebskassenverbrauch von Anfang des Jahres bis heute betrug 22,9 Millionen US-Dollar bei einem Nettoverlust von 28,0 Millionen US-Dollar (1,19 US-Dollar pro Aktie).

Positive
  • Received FDA approval to proceed with Phase 3 trial for amezalpat
  • Secured partnership with Roche for amezalpat development
  • Raised $19.9M through ATM offering post-quarter
  • Obtained NCI funding for TPST-1495 Phase 2 trial
Negative
  • Increased net loss to $10.6M in Q3 2024 vs $6.8M in Q3 2023
  • R&D expenses increased 81% YoY to $7.6M
  • Operating cash burn of $22.9M in first nine months
  • Cash position decreased to $22.1M from $39.2M at end of 2023

Insights

The Q3 results reveal significant financial and operational developments. The company's cash position decreased to $22.1 million from $39.2 million, but was bolstered by a subsequent $19.9 million ATM raise. Net loss widened to $10.6 million ($0.41 per share) from $6.8 million in Q3 2023, primarily due to increased R&D expenses.

The 81% increase in R&D expenses to $7.6 million reflects intensified clinical development activities, particularly for amezalpat. The Roche partnership for the Phase 3 trial, while not providing direct funding, offers valuable support through drug supply, potentially reducing development costs. The cash burn rate and recent capital raise suggest runway into mid-2025, though additional financing may be needed to complete the pivotal trial.

The regulatory and clinical progress for amezalpat represents a significant milestone. The FDA's "Study May Proceed" letter and agreement on Phase 3 trial design, including the possibility of early efficacy analysis, could accelerate the development timeline by up to 8 months. The Roche collaboration strengthens the trial's execution potential, particularly given their expertise in HCC treatment with atezolizumab and bevacizumab.

The expansion into FAP with TPST-1495, supported by NCI funding, provides a strategic diversification of the pipeline. This rare disease indication could offer accelerated development pathways and potential orphan drug designation benefits, though market size would be compared to HCC.

  • Building upon a successful end-of-Phase 2 meeting, received FDA “Study May Proceed” letter for pivotal Phase 3 trial of amezalpat (TPST-1120) combination therapy to treat first-line HCC
  • Announced agreement with Roche to support advancement of amezalpat into first-line HCC pivotal Phase 3 trial
  • Received final funding approval from NCI to move TPST-1495 into a Phase 2 trial in FAP
  • Expanded leadership team to strengthen global clinical expertise

BRISBANE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended September 30, 2024, and provided a corporate update.

“During the third quarter, the team continued to move amezalpat successfully towards the pivotal study, achieving important milestones on both the regulatory and business fronts,” said Stephen Brady, president and chief executive officer of Tempest. “Based on the positive randomized Phase 2 data and a Phase 3 plan we believe is designed for success, we were thrilled to receive broad agreement with the FDA. Coupled with Roche’s support for the Phase 3 study, the third quarter further solidified the foundation of a pivotal study that we hope will result in a new and meaningful therapy for first-line HCC patients.”

Recent Highlights

  • Amezalpat (TPST-1120) (clinical PPARα antagonist):
    • Received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate amezalpat in combination with atezolizumab (Tecentriq®) and bevacizumab (Avastin®), the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma.
    • 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, a form of liver cancer with high unmet need.
      • Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study. The agreement builds on a clinical collaboration between the companies pursuant to which amezalpat was combined with atezolizumab and bevacizumab in first-line HCC patients and compared to atezolizumab and bevacizumab alone in a randomized Phase 1b/2 study. Tempest retains all development and commercial rights to amezalpat.
    • 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. Key outcomes included:
      • Agreement on Phase 3 study design, including the standard-of-care control arm and the primary and secondary study endpoints.
      • Agreement on appropriateness of the current amezalpat dose and schedule for the Phase 3 study.
      • Agreement on the Phase 3 statistical plan, including a pre-specified early efficacy analysis that the company currently estimates could shorten the time to primary analysis by up to 8 months.
  • 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.

Other Potential Future Milestones

  • TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
    • Plan to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in 2024 or early 2025 under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention.
    • Expect to disclose data from the TPST-1495 Phase 1 combination arm in patients with advanced endometrial cancer in 2025.

Financial Results

Third Quarter 2024

  • Tempest ended the quarter with $22.1 million in cash and cash equivalents, compared to $39.2 million on December 31, 2023. Subsequent to September 30, 2024, Tempest raised an additional $19.9 million in net proceeds through the sale of 17 million shares of common stock under the Company’s at-the-market (ATM) program.
  • Net loss and net loss per share for the quarter ended September 30, 2024, were $10.6 million and $0.41, respectively, compared to $6.8 million and $0.48, respectively, for the same period in 2023.
  • Research and development expenses for the quarter were $7.6 million compared to $4.2 million for the same period in 2023. The $3.4 million increase was primarily due to an increase in costs incurred from contract research and manufacturing organizations.
  • General and administrative expenses for the quarter were $3.0 million compared to $2.4 million for the same period in 2023. The $0.6 million increase was primarily due to an increase in stock-based compensation, and consulting and professional services.

Year-to-Date

  • Cash used in operating activities for the nine months ended September 30, 2024 was $22.9 million.
  • Net loss and net loss per share for the nine months ended September 30, 2024 were $28.0 million and $1.19, respectively, compared to $22.0 million and $1.57, respectively, for the same period in 2023.
  • Research and development expenses for the nine months ended September 30, 2024 were $17.7 million compared to $13.3 million for the same period in 2023. The $4.4 million increase was primarily due to an increase in costs incurred from contract research and manufacturing organizations, as well as an increase in stock-based compensation.
  • General and administrative expenses for the nine months ended September 30, 2024 were $10.4 million compared to $8.3 million for the same period in 2023. The $2.1 million increase was primarily due to an increase in stock-based compensation as well as 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; Roche’s future supply of atezolizumab for use in the Company’s pivotal Phase 3 trial; anticipated therapeutic benefit and regulatory development of the Company’s product candidates; the Company’s anticipated cash runway; the Company’s ability to deliver on potential value-creating milestones; the Company’s ability to advance into a late-stage clinical company; 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) 
      
 September 30,
2024
  December 31,
2023
 
Assets     
Current assets     
Cash and cash equivalents$22,116  $39,230 
Prepaid expenses and other current assets 1,436   1,133 
Total current assets 23,552   40,363 
      
Property and equipment, net 932   840 
Operating lease right-of-use assets 8,904   9,952 
Other noncurrent assets 448   448 
      
Total assets$33,836  $51,603 
      
Liabilities and Stockholders' Equity     
Current liabilities     
Accounts payable$1,697  $845 
Accrued expenses 1,459   1,673 
Current loan payable, net 8,504   4,285 
Current operating lease liabilities 828   952 
Accrued compensation 1,402   1,543 
Interest payable 83   113 
Total current liabilities 13,973   9,411 
      
Loan payable, net -   6,264 
Operating lease liabilities 8,406   9,160 
Total liabilities 22,379   24,835 
      
Stockholders' equity     
Common stock 27   22 
Additional paid-in capital 204,723   192,009 
Accumulated deficit (193,293)  (165,263)
Total stockholders' equity 11,457   26,768 
Total liabilities and stockholders' equity$33,836  $51,603 
        


TEMPEST THERAPEUTICS, INC. 
Consolidated Statements of Operations 
(in thousands, except per share amounts) 
            
            
 Three months
ended
  Three months
ended
  Nine months
ended
  Nine months
ended
 
 September 30,
2024
  September 30,
2023
  September 30,
2024
  September 30,
2023
 
Expenses:           
Research and development$7,557  $4,221  $17,734  $13,315 
General and administrative 2,994   2,371   10,374   8,328 
            
Operating loss (10,551)  (6,592)  (28,108)  (21,643)
            
Other income (expense), net:           
Interest expense (329)  (373)  (1,069)  (1,072)
Interest and other income, net 324   179   1,147   712 
            
Net loss$(10,556) $(6,786) $(28,030) $(22,003)
Net loss per share$(0.41) $(0.48) $(1.19) $(1.57)
                

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 was Tempest Therapeutics (TPST) Q3 2024 net loss?

Tempest Therapeutics reported a net loss of $10.6 million ($0.41 per share) for Q3 2024.

What is the status of TPST's amezalpat Phase 3 trial?

FDA issued a 'Study May Proceed' letter for amezalpat's pivotal Phase 3 trial in combination with atezolizumab and bevacizumab for first-line HCC treatment.

How much cash did TPST raise in their recent ATM offering?

TPST raised $19.9 million in net proceeds through the sale of 17 million shares under their ATM program after Q3 2024.

What was TPST's cash position as of Q3 2024?

Tempest had $22.1 million in cash and cash equivalents at the end of Q3 2024.

Tempest Therapeutics, Inc.

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