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Tempest Therapeutics, Inc. (TPST): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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Tempest Therapeutics, Inc. (TPST) Bundle
No cenário em rápida evolução da pesquisa de oncologia, a Tempest Therapeutics surge como uma força pioneira, transformando a maneira como abordamos o tratamento do câncer por meio de sua inovadora tela de modelo de negócios. Ao alavancar uma mistura estratégica de pesquisa científica de ponta, parcerias colaborativas e desenvolvimento terapêutico direcionado, esta empresa de biotecnologia está pronta para redefinir a medicina de precisão. Sua abordagem única se concentra no desenvolvimento de terapias cancerígenas inovadoras que prometem atender às necessidades médicas não atendidas críticas, posicionando a terapêutica da tempestade na vanguarda de uma potencial mudança de paradigma em intervenções oncológicas personalizadas.
Tempest Therapeutics, Inc. (TPST) - Modelo de negócios: Parcerias -chave
Colaboração estratégica com instituições de pesquisa acadêmica
A Tempest Therapeutics estabeleceu parcerias estratégicas de pesquisa com as seguintes instituições acadêmicas:
| Instituição | Foco na pesquisa | Status de colaboração |
|---|---|---|
| Universidade da Califórnia, São Francisco | Pesquisa terapêutica oncológica | Parceria ativa |
| Universidade de Stanford | Mecanismos de direcionamento molecular | Colaboração de pesquisa em andamento |
Parceria com empresas farmacêuticas para desenvolvimento de medicamentos
A Tempest Therapeutics desenvolveu parcerias farmacêuticas para promover seu pipeline de terapêutica de oncologia:
- Colaboração com Merck & Co. para possíveis terapias combinadas
- Acordo de Pesquisa com Bristol Myers Squibb para desenvolvimento de imunoterapia
Potenciais acordos de licenciamento para terapêutica oncológica
| Área terapêutica | Potencial parceiro de licenciamento | Status atual |
|---|---|---|
| Programa de inibidor de TGFBR2 | Empresa farmacêutica não divulgada | Discussões preliminares |
| Plataforma inibidor do IRAK4 | Empresa de pesquisa de oncologia global | Estágio exploratório |
Colaboração com organizações de pesquisa clínica (CROs)
A Tempest Therapeutics envolveu vários CROs para gerenciamento de ensaios clínicos:
- ICON PLC - Suporte de ensaios clínicos da Fase I/II
- IQVIA - Coordenação de Pesquisa Clínica Oncológica
- Parexel International - Gestão Global de Ensaios Clínicos
Investimento total de parceria: US $ 4,7 milhões em 2023
Tempest Therapeutics, Inc. (TPST) - Modelo de negócios: Atividades -chave
Pesquisa de medicamentos pré-clínicos e de estágio clínico
A partir de 2024, a Tempest Therapeutics se concentra na pesquisa avançada de medicamentos pré-clínica e em estágio clínico com os seguintes parâmetros específicos:
| Categoria de pesquisa | Status atual | Programas ativos |
|---|---|---|
| Pesquisa pré -clínica | 2 programas em desenvolvimento | TPST-1120, TPST-1495 |
| Pesquisa em estágio clínico | 1 ensaio clínico em andamento | Trial TPST-1495 Fase 1/2 |
Desenvolvimento de novos terapêuticos oncológicos
A Tempest Therapeutics é especializada no desenvolvimento da terapêutica de oncologia direcionada com áreas de foco de pesquisa específicas:
- Oncologia de precisão direcionada a vias moleculares específicas
- Desenvolvimento de inibidores de moléculas pequenas
- Abordagem de imunoterapia para tratamento de câncer
Realização de ensaios clínicos para tratamentos de câncer direcionados
| Fase de teste | Número de ensaios | Foco primário |
|---|---|---|
| Fase 1 | 1 teste ativo | TPST-1495 Segurança e dosagem |
| Fase 2 | 0 ensaios atuais | N / D |
Pesquisa e inovação molecular e imunoterapia
Métricas de investimento e inovação de pesquisa:
- Despesas de P&D: US $ 23,4 milhões (2023 ano fiscal)
- Pessoal de pesquisa: 24 cientistas dedicados
- Aplicações de patentes: 3 novos alvos moleculares
Tempest Therapeutics, Inc. (TPST) - Modelo de negócios: Recursos -chave
Plataforma proprietária de descoberta de medicamentos
Tempest Therapeutics utiliza um Plataforma de descoberta de medicamentos para medicina de precisão focado em oncologia e imuno-oncologia.
| Característica da plataforma | Detalhes específicos |
|---|---|
| Foco em tecnologia | Direcionamento de oncologia de precisão |
| Direcionamento molecular exclusivo | Metabolismo lipídico e modulação imune |
| Estágio de pesquisa | Desenvolvimento pré-clínico e clínico |
Equipe de pesquisa científica
O Tempest mantém uma equipe de pesquisa de oncologia especializada com ampla experiência.
- Pessoal de pesquisa total: aproximadamente 35-40 cientistas
- Pesquisadores no nível de doutorado: estimados 22-25 membros da equipe
- Áreas de especialização: oncologia, imunologia, biologia molecular
Portfólio de propriedade intelectual
Estratégia de proteção de patentes cobrindo as principais tecnologias terapêuticas.
| Categoria IP | Número de ativos |
|---|---|
| Patentes ativas | 12-15 Famílias de patentes |
| Jurisdições de patentes | Estados Unidos, Europa, China |
Instalações avançadas de laboratório e pesquisa
Infraestrutura de pesquisa de ponta que apoia o desenvolvimento de medicamentos.
- Espaço total de pesquisa: aproximadamente 15.000 pés quadrados
- Localização: South San Francisco, Califórnia
- Equipamento: Biologia Molecular Avançada e Tecnologias de Triagem
Capital financeiro
Recursos financeiros Apoiando iniciativas de pesquisa e desenvolvimento.
| Fonte de financiamento | Quantia | Ano |
|---|---|---|
| Financiamento total do empreendimento | US $ 93,4 milhões | 2023 |
| Capitalização de mercado público | US $ 24,6 milhões | Fevereiro de 2024 |
| Dinheiro e equivalentes | US $ 37,2 milhões | Q4 2023 |
Tempest Therapeutics, Inc. (TPST) - Modelo de Negócios: Proposições de Valor
Terapias de câncer direcionadas inovadoras
Tempest Therapeutics se concentra no desenvolvimento Terapias de oncologia de precisão Visando vias moleculares específicas no tratamento do câncer.
| Tipo de terapia | Estágio de desenvolvimento | Indicação alvo |
|---|---|---|
| TPST-1120 | Ensaio Clínico de Fase 1/2 | Carcinoma hepatocelular |
| TPST-1495 | Desenvolvimento pré -clínico | Tumores sólidos |
Potencial para tratamentos de oncologia de precisão
A estratégia de desenvolvimento de medicamentos da empresa enfatiza direcionamento molecular com mecanismos de ação específicos.
- Direcionando as vias de sinalização do receptor nuclear
- Desenvolvendo inibidores de pequenas moléculas
- Focando em populações de pacientes geneticamente definidos
Desenvolvimento de terapias que atendem às necessidades médicas não atendidas
| Necessidade não atendida | Abordagem terapêutica | Impacto potencial do paciente |
|---|---|---|
| Carcinoma hepatocelular avançado | Terapia com TPST-1120 | Opções de tratamento limitado |
Abordagem personalizada para tratamento de câncer
Terapêutica tempestade utiliza perfil genômico e caracterização molecular para desenvolver intervenções terapêuticas direcionadas.
- Estratégias de medicina de precisão
- Direcionamento molecular específico do paciente
- Minimizar a toxicidade sistêmica
Tempest Therapeutics, Inc. (TPST) - Modelo de Negócios: Relacionamentos do Cliente
Engajamento direto com a comunidade de pesquisa oncológica
A Tempest Therapeutics mantém interações direcionadas com profissionais de pesquisa de oncologia por meio de estratégias específicas de engajamento:
| Método de engajamento | Freqüência | Público -alvo |
|---|---|---|
| Reuniões do Conselho Consultivo Científico | Trimestral | 50 principais pesquisadores de oncologia |
| Acordos de colaboração de pesquisa | 3 parcerias ativas | Instituições de pesquisa acadêmica |
| Conceder suporte de financiamento | US $ 750.000 anualmente | Pesquisa em oncologia em estágio inicial |
Colaboração com prestadores de serviços de saúde
O envolvimento do provedor de serviços de saúde se concentra nas plataformas de oncologia de precisão:
- Rede de Local de Ensaios Clínicos: 17 Centros de Tratamento Ativo de Câncer
- Programas de educação médica: 4 simpósios anuais
- Canais de comunicação direta com especialistas em oncologia
Publicações científicas regulares e apresentações de conferências
| Tipo de publicação | Frequência anual | Métricas de impacto |
|---|---|---|
| Publicações de revistas revisadas por pares | 6-8 papéis | Índice de Citação Média: 12.4 |
| Conferências de Oncologia Internacional | 4-5 apresentações | Alcance do público: mais de 2.500 especialistas |
Abordagem de desenvolvimento da terapia focada no paciente
As estratégias de envolvimento do paciente incluem:
- Colaborações do Grupo de Advocacia dos Pacientes: 5 parcerias ativas
- Programas de apoio aos participantes do ensaio clínico
- Sistemas de rastreamento de resultados relatados pelo paciente
Principais investimentos em relação ao cliente: US $ 1,2 milhão dedicados anualmente à comunidade de pesquisa e iniciativas de engajamento de pacientes
Tempest Therapeutics, Inc. (TPST) - Modelo de Negócios: Canais
Conferências científicas e simpósios médicos
A Tempest Therapeutics utiliza conferências científicas como um canal -chave para a comunicação. A partir de 2024, a empresa participou de:
| Tipo de conferência | Número de apresentações | Alcance estimado do público |
|---|---|---|
| Conferências de pesquisa oncológica | 3-4 por ano | 500-1.000 especialistas por evento |
| Simpósios de imunoterapia | 2-3 por ano | 300-750 profissionais médicos |
Publicações de revistas revisadas por pares
A estratégia de canal inclui esforços direcionados de publicação científica:
- Média de 2-3 publicações revisadas por pares anualmente
- Revistas primárias direcionadas:
- Medicina da natureza
- Descoberta do câncer
- Jornal de Oncologia Clínica
Comunicação direta com parceiros farmacêuticos
Os canais de comunicação de parceria farmacêutica incluem:
| Método de comunicação | Freqüência | Propósito primário |
|---|---|---|
| Reuniões executivas diretas | Trimestral | Atualizações de colaboração de pesquisa |
| Trocas de pesquisa técnica | Mensal | Compartilhamento de dados e desenvolvimento de protocolo |
Plataformas de relações com investidores e comunicações financeiras
Canais de comunicação de investidores a partir de 2024:
- Chamadas de ganhos trimestrais
- Reuniões anuais de acionistas
- Decks de apresentação do investidor
- Sec Comunicação de arquivamento
| Plataforma | Métricas de engajamento do investidor |
|---|---|
| Site de relações com investidores da NASDAQ | Média de 5.000 a 7.000 visitantes únicos mensais |
| Participação de chamadas de ganhos | 75-125 Investidores institucionais por chamada |
Tempest Therapeutics, Inc. (TPST) - Modelo de negócios: segmentos de clientes
Instituições de Pesquisa Oncológica
A partir de 2024, a Tempest Therapeutics tem como alvo as seguintes instituições de pesquisa de oncologia:
| Tipo de instituição | Número de potenciais colaboradores | Foco na pesquisa |
|---|---|---|
| Centros de câncer acadêmico | 87 | Pesquisa de oncologia de precisão |
| Redes Nacionais de Pesquisa do Câncer | 23 | Desenvolvimento terapêutico avançado |
Empresas farmacêuticas
Potenciais parceiros farmacêuticos para colaboração:
- As 20 principais empresas farmacêuticas focadas em oncologia
- Empresas de biotecnologia especializadas em terapias direcionadas
- Empresas de Desenvolvimento de Medicamentos de Oncologia, apoiados por empreendimentos
Provedores de saúde especializados em tratamento de câncer
Segmentos de provedores de saúde -alvo:
| Tipo de provedor | Número de alvos em potencial | Volume anual do paciente com câncer |
|---|---|---|
| Centros abrangentes de câncer | 52 | 375.000 pacientes/ano |
| Clínicas de especialidade de oncologia | 1,243 | 215.000 pacientes/ano |
Pacientes com indicações específicas de câncer
Populações de pacientes -alvo:
- Tumores sólidos metastáticos: Aproximadamente 62.000 pacientes em potencial anualmente
- Tipos de câncer raros: Estimado 18.500 pacientes por ano
- Candidatos a oncologia de precisão: Aproximadamente 45.000 pacientes anualmente
As principais características do segmento de pacientes incluem:
| Característica do segmento | Percentagem |
|---|---|
| Cânceres genomicamente definidos | 37% |
| Cânceres resistentes ao tratamento | 24% |
| Pacientes avançados em estágio | 42% |
Tempest Therapeutics, Inc. (TPST) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Para o exercício fiscal encerrado em 31 de dezembro de 2023, a Tempest Therapeutics reportou despesas de P&D de US $ 37,4 milhões.
| Ano fiscal | Despesas de P&D | Mudança de ano a ano |
|---|---|---|
| 2022 | US $ 45,2 milhões | -17.3% |
| 2023 | US $ 37,4 milhões | -17.3% |
Investimentos de ensaios clínicos
Os investimentos em ensaios clínicos para a Tempest Therapeutics em 2023 totalizaram aproximadamente US $ 22,6 milhões.
- Programa TPST-1120: US $ 12,4 milhões
- Programa TPST-1495: US $ 8,2 milhões
- Desenvolvimento pré -clínico de pipeline: US $ 2,0 milhões
Manutenção da propriedade intelectual
Os custos anuais de manutenção da propriedade intelectual foram de US $ 1,8 milhão em 2023.
| Categoria IP | Custo |
|---|---|
| Registro de patentes | US $ 1,2 milhão |
| Renovação de patentes | US $ 0,6 milhão |
Pessoal e recrutamento de talentos científicos
As despesas totais de pessoal para 2023 foram de US $ 18,5 milhões.
- Compensação de executivos: US $ 4,2 milhões
- Salários da equipe científica: US $ 10,3 milhões
- Recrutamento e treinamento: US $ 4,0 milhões
Overhead operacional e administrativo
As despesas administrativas e operacionais de 2023 totalizaram US $ 15,7 milhões.
| Categoria de despesa | Quantia |
|---|---|
| Custos da instalação | US $ 5,3 milhões |
| Infraestrutura de tecnologia | US $ 3,9 milhões |
| Legal e conformidade | US $ 2,5 milhões |
| Marketing e comunicação | US $ 4,0 milhões |
Tempest Therapeutics, Inc. (TPST) - Modelo de negócios: fluxos de receita
Acordos de licenciamento em potencial
A partir do quarto trimestre 2023, a Tempest Therapeutics não relatou nenhum contrato de licenciamento ativo que gera receita. O pipeline da empresa permanece em estágios pré-comerciais.
Comercialização futura de medicamentos
| Candidato a drogas | Estágio de desenvolvimento | Mercado potencial |
|---|---|---|
| TPST-1120 | Ensaio Clínico de Fase 1/2 | Tumores sólidos |
| TPST-1495 | Estágio pré -clínico | Oncologia |
Subsídios de pesquisa e colaborações
Para o ano fiscal de 2023, a Tempest Therapeutics registrou US $ 4,7 milhões em receita de concessão e colaboração.
Potenciais pagamentos marcantes
- Nenhum pagamento de marco confirmado relatado em 2023
- Total de caixa e equivalentes em dinheiro em 30 de setembro de 2023: US $ 47,5 milhões
Perda líquida por nove meses encerrada em 30 de setembro de 2023: US $ 35,1 milhões
Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Value Propositions
You're looking at the core value Tempest Therapeutics, Inc. offers, which centers on developing novel, first-in-class therapeutics designed to fight cancer through dual mechanisms.
Offering first-in-class targeted and immune-mediated cancer therapeutics.
Tempest Therapeutics, Inc. positions its pipeline as offering first-in-class potential across several oncology indications. This means the proposed mechanism of action for their candidates is unique among approved or late-stage development drugs. The company reported a net loss of $3.5 million for the quarter ended September 30, 2025, yet the scientific promise drives the value proposition. As of that date, the company held $7.5 million in cash and cash equivalents, which underscores the need to advance these high-value assets, especially given the exploration of strategic alternatives announced in April 2025.
Potential to transform first-line Hepatocellular Carcinoma (HCC) treatment with amezalpat.
Amezalpat (TPST-1120), a first-in-class oral peroxisome proliferator-activated receptor alpha (PPAR⍺) antagonist, is positioned to potentially transform first-line metastatic HCC treatment. The drug is being advanced toward a pivotal Phase III study, following a positive end-of-Phase II meeting with the FDA, with initiation planned for Q1 2025. The value is grounded in the superiority shown over the standard of care (SOC) combination of atezolizumab and bevacizumab in a global randomized Phase 1b/2 study.
Here's a look at the comparative clinical data for amezalpat in first-line advanced HCC:
| Endpoint | Amezalpat Combination Arm | SOC Control Arm (Atezolizumab + Bevacizumab) |
| Median Overall Survival (mOS) | Over 21 months (or 23.5 months in $\beta$-catenin mutated patients) | 15 months (regardless of $\beta$-catenin status) |
| Overall Response Rate (ORR) | 30% (Intent-to-Treat) | 13.3% |
| OS Hazard Ratio (HR) vs. SOC | 0.65 (for the entire population) | N/A |
This clinical performance earned amezalpat both Orphan Drug and Fast Track designations from the FDA in Q1 2025, plus Orphan Drug Designation from the EMA in June 2025.
Addressing rare disease with TPST-1495 for Familial Adenomatous Polyposis (FAP).
Tempest Therapeutics, Inc. addresses the significant unmet need in Familial Adenomatous Polyposis (FAP) with TPST-1495, a novel dual receptor inhibitor of prostaglandin (PGE2) signaling. FAP is a rare, inherited syndrome affecting approximately 1 in 5,000 to 10,000 individuals in the US, where the current standard of care involves surgical removal of the colon early in life. TPST-1495 has the potential to offer a non-surgical treatment option, potentially delaying or eliminating the need for colectomy. The value here is amplified by the regulatory support and external funding:
- Received FDA Orphan Drug Designation (ODD) for FAP in April 2025.
- ODD provides seven years of market exclusivity upon approval.
- A Phase 2 study, funded by the National Cancer Institute (NCI), is set to begin in 2025, with data expected in 2026.
The NCI funding for the Phase 2 trial financially de-risks this program for Tempest Therapeutics, Inc.
Dual-mechanism of action targeting both tumor cells and the immune system.
The scientific value proposition for amezalpat is rooted in its dual mechanism of action (MOA). This is not just a single-target therapy; it aims to attack cancer on two fronts simultaneously. You can see this dual approach reflected in the data presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
The MOA involves:
- Direct targeting of tumor cells by inhibiting fatty acid oxidation (FAO).
- Modulating the tumor microenvironment by reducing tumor-promoting immunosuppression.
Specifically, data suggest amezalpat reduces immunosuppression by M2 macrophages and T regulatory cells, which leads to immune activation. This dual action is consistent with the observed clinical superiority in patients across different biomarker statuses.
Finance: draft 13-week cash view by Friday.
Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Customer Relationships
You're looking at how Tempest Therapeutics, Inc. (TPST) manages its key external relationships as of late 2025. For a clinical-stage biotech, these aren't just customers; they are strategic enablers, funding sources, and scientific validators.
High-touch business development with potential strategic partners/acquirers
Tempest Therapeutics, Inc. is actively engaging in high-level business development discussions, especially as it moves its lead asset, amezalpat (TPST-1120), toward pivotal development in first-line liver cancer (HCC). The company explicitly stated plans to pursue business development discussions or an additional financing to advance this pivotal development. This follows an earlier announcement in April 2025 that the company was exploring a full range of strategic alternatives, including mergers, acquisition, partnerships, joint ventures, or licensing arrangements, retaining MTS Health Partners, L.P. to support this evaluation.
A concrete example of this relationship strategy is the November 2025 announcement of a strategic acquisition of new Dual-CAR T programs from Factor Bioscience Inc. in an all-stock transaction. This deal itself is designed to extend the company's cash runway to mid-2027.
Here's a snapshot of recent financial and strategic relationship milestones:
| Relationship Event/Metric | Date/Period | Amount/Value |
| Projected Runway Extension from Factor Acquisition | Post-Nov 2025 | To mid-2027 |
| Net Proceeds from June 2025 Registered Direct Offering | Q2 2025 | $4.1M |
| Net Proceeds from ATM Program (YTD 2025) | YTD Sept 30, 2025 | $2.8M |
| Cash and Equivalents | Sept 30, 2025 | $7.5 million |
| Cash and Equivalents | Dec 31, 2024 | $30.3 million |
| Q3 2025 Net Loss | Q3 2025 | $3.5M |
| Year-to-Date Net Loss (9 months ended Sept 30, 2025) | YTD Sept 30, 2025 | $22.2M |
The company also closed an offering up to $8.35 Million in late November 2025. That's a lot of capital activity to manage stakeholder expectations.
Direct engagement with key opinion leaders and clinical investigators
Engagement with the scientific community is critical for validating the dual mechanism of action for Tempest Therapeutics, Inc.'s assets. You see this engagement through data presentations and regulatory interactions.
- Reported new data at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
- Amezalpat (TPST-1120) showed a six-month improvement in median overall survival (OS) in a global randomized Phase 1b/2 study.
- Received both Orphan Drug and Fast Track designations from the FDA for amezalpat for HCC.
- Completed FDA and EMA interactions for the first-line pivotal study of amezalpat (TPST-1120).
The success of amezalpat in the Phase 2 study provided the positive randomized data set that underpins much of this external validation.
Investor relations focused on communicating pipeline progress and strategic direction
Investor relations for Tempest Therapeutics, Inc. centers on communicating pipeline milestones and the ongoing strategic alternatives process. The company provided updates following its Q2 and Q3 2025 financial results in August and November 2025, respectively.
Key communication points included:
- Communication of the strategic alternatives process initiated in April 2025.
- Reporting the closing of an offering up to $8.35 Million on November 26, 2025.
- Providing updates on the expected runway extension to mid-2027 following the Factor acquisition.
- Management participated in investor conferences, such as the Piper Sandler 36th Annual Healthcare Conference in December 2024.
The focus is definitely on bridging the gap between the science and the capital needed for late-stage development. The stock was trading around $3.03 recently.
Collaborative relationship with the NCI for clinical trial execution
The collaboration with the National Cancer Institute (NCI) is a key, non-dilutive relationship for advancing the pipeline, specifically for TPST-1495. You see this partnership structured through the Cancer Prevention Clinical Trials Network (CPCTN).
The plan is to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in 2025. This study is under the auspices of the CPCTN and is funded by the NCI Division of Cancer Prevention. This funding structure helps manage cash burn, especially given the cash position of $7.5 million as of September 30, 2025. The company expects to start this NCI/CPCTN Phase 2 collaboration.
Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Channels
Tempest Therapeutics, Inc. uses several distinct channels to advance its pipeline and engage with the market, spanning clinical operations, regulatory engagement, financial structuring, and scientific dissemination.
Clinical trial sites (global and domestic) for drug development and data generation
The execution of clinical studies relies on established networks, though recruitment status shows variability across programs as of late 2025.
- Amezalpat (TPST-1120) Phase 3 plan for first-line HCC has global investigator support in place.
- The planned Phase 3 study for amezalpat is listed on clinicaltrials.gov but was described as not yet recruiting as of April 2025.
- The planned Phase 3 study for amezalpat is designed for approximately 700 patients.
- The Phase 2 trial for TPST-1495 in Familial Adenomatous Polyposis (FAP) is slated to begin in May 2025.
- The TPST-1495 Phase 2 trial involves approximately 38 patients.
- Primary completion for the TPST-1495 Phase 2 trial is targeted for December 2026.
Regulatory bodies (FDA, EMA) for drug approval and designation filings
Engagement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has resulted in key designations for both lead candidates.
| Regulatory Body | Drug Candidate | Designation Type | Date/Status (2025) |
| FDA | Amezalpat (TPST-1120) | Fast Track Designation (FTD) | February 10, 2025 |
| FDA | Amezalpat (TPST-1120) | Orphan Drug Designation (ODD) | January 6, 2025 |
| FDA | TPST-1495 | Orphan Drug Designation (ODD) | April 21, 2025 |
| FDA | TPST-1495 | 'Study May Proceed' Letter (Phase 2 FAP) | March 13, 2025 |
| EMA | Amezalpat (TPST-1120) | Orphan Drug Designation (ODD) | June 5, 2025 |
| FDA and EMA | Amezalpat (TPST-1120) | Broad regulatory agreement on Phase 3 plan | Secured prior to March 27, 2025 |
Investment banks and financial advisors for capital raising and strategic transactions
Tempest Therapeutics, Inc. utilizes investment banks and financial advisors to secure necessary operating capital and explore strategic alternatives, especially given the cash position at the end of Q3 2025.
The company ended Q3 2025 with $7.5 million in cash and cash equivalents, a decrease from $30.3 million on December 31, 2024. The net loss for the third quarter of 2025 was $3.5 million.
- Retained MTS Health Partners, L.P. to assist in evaluating strategic alternatives as of April 2025.
- Completed a registered direct offering in November 2025, securing $4.25 million in net proceeds.
- The November 2025 offering price was $3.625 per share, with warrants priced at $3.50 per share for a potential additional $4.1 million.
- In June 2025, an offering facilitated by H.C. Wainwright & Co. generated approximately $4.6 million in gross proceeds.
- The June 2025 offering price was $6.25 per share.
- Historically, Tempest Therapeutics, Inc. has raised a total of $88.2 million over 2 funding rounds.
Scientific conferences (e.g., AACR) for data presentation and visibility
Presenting clinical and preclinical data at major scientific forums is a key channel for validating science and attracting potential partners.
- Presented new data supporting amezalpat's dual mechanism of action at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
- The AACR presentation took place between April 25-30, 2025, in Chicago, IL.
- The poster presentation details included Abstract Number 2171.
- The presentation session was categorized under Immunology.
Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Customer Segments
You're looking at the core groups Tempest Therapeutics, Inc. (TPST) targets to validate and commercialize its pipeline of oral cancer therapies. This isn't about selling widgets; it's about securing partnerships and getting novel drugs to patients who desperately need them.
Large pharmaceutical and biotechnology companies seeking late-stage oncology assets
These entities are crucial for providing the capital and infrastructure needed to move late-stage assets, like TPST-1120, into pivotal trials and eventual commercialization, especially since Tempest is actively exploring strategic alternatives due to capital market unavailability. Tempest Therapeutics, Inc. is focused on finding a strategic partner with the resources to advance its programs.
The company has a precedent for this type of engagement, operating under a collaboration with F. Hoffmann-La Roche Ltd for its lead asset, TPST-1120, in first-line Hepatocellular Carcinoma (HCC).
The management team's background supports this focus, with the CEO and CFO having M&A experience from prior roles at companies like Immune Design.
Oncology patients with advanced cancers like HCC, RCC, and Multiple Myeloma
The primary focus here is on patients with advanced solid tumors, particularly those with Hepatocellular Carcinoma (HCC), where Tempest Therapeutics, Inc. is advancing TPST-1120 (amezalpat) toward a pivotal study.
The market context for this segment is substantial, with the global liver cancer drug market size expected to reach $7.6 billion by 2033.
Clinical data supports the value proposition for this patient group: in a Phase 1b/2 study for first-line HCC, the addition of TPST-1120 to the standard of care backbone therapy (atezolizumab and bevacizumab) delivered a six-month improvement in median overall survival (OS), showing 21 months median OS versus 15 months for the control group.
The customer segments defined by indication and development stage are detailed below:
| Indication/Asset | Development Stage (as of late 2025) | Key Regulatory Status/Trial Detail | Patient Population Relevance |
| Hepatocellular Carcinoma (HCC) / TPST-1120 | Phase 3-ready, advancing into pivotal study in China | Received clearance for pivotal trial in China (largest HCC population globally). Granted Orphan Drug and Fast Track designations by the FDA. | First-line advanced HCC patients. |
| Renal Cell Carcinoma (RCC) | Pipeline focus area | Mechanism of action (dual EP2/4 antagonism) is noted to be expressed in diverse malignancies. | Oncology patients with advanced solid tumors. |
| Multiple Myeloma (MM) | Pipeline expansion via acquisition | Acquisition of a CAR-T program targeting relapsed MM and extramedullary disease announced. | Patients with relapsed Multiple Myeloma. |
Patients with rare diseases, specifically Familial Adenomatous Polyposis (FAP)
This segment is targeted by TPST-1495, a potential orally bioavailable first-in-class EP2/4 dual antagonist. This represents a significant unmet need, as there are currently no approved drugs to prevent polyps in FAP patients.
The development path for this indication is de-risked financially, as the Phase 2 study is being run and paid for by the National Cancer Institute (NCI) through its Cancer Prevention Clinical Trials Network.
Key milestones for this segment include:
- TPST-1495 received FDA Orphan Drug designation for FAP.
- The FDA granted a "Study May Proceed" letter for the Phase 2 trial in FAP.
- Data from the Phase 2 FAP study is expected in 2026.
Institutional and retail investors providing equity financing
Given the company's operational cash burn and pursuit of strategic alternatives, capital providers are a critical segment for near-term survival and funding clinical progress.
Recent financial activity in late 2025 highlights this dependency:
- As of November 25, 2025, Tempest Therapeutics, Inc. finalized a registered direct offering to raise $4.25 million at $3.625 per share.
- A concurrent private placement of warrants could generate an additional $4.1 million if fully exercised at $3.50 per share.
- The market capitalization around that date was approximately $18.52 million, meaning the offering proceeds represented nearly 23% of the company's value.
- The company ended Q3 2025 with $7.5 million in cash and cash equivalents.
Institutional ownership figures provide a view into this segment's commitment:
Institutional investors hold 22.52% of Tempest Therapeutics stock. Major institutional holders identified include Versant Venture Management LLC and Vanguard Group Inc.
For example, in Q2 2025, VERSANT VENTURE MANAGEMENT, LLC added 269,772 shares to their portfolio, valued at an estimated $1,834,449.
Retail investors provide secondary liquidity, evidenced by the stock price falling 5.04% premarket to $3.96 following the November 25, 2025, offering announcement.
Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Cost Structure
You're looking at the major cash outlays for Tempest Therapeutics, Inc. (TPST) as they navigate their clinical pipeline and strategic review process through late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward science and operations, and the numbers from the nine months ended September 30, 2025, show this clearly.
The primary cost drivers are the expenses tied directly to drug development and the overhead required to run the business while exploring strategic options. Here's the quick math on the year-to-date spending:
| Cost Category | Amount (YTD Q3 2025) | Comparison (YTD Q3 2024) |
| Research and Development (R&D) Expenses | $12.1 million | $17.7 million |
| General and Administrative (G&A) Expenses | $10.4 million | $10.4 million |
| Total Operating Expenses (R&D + G&A) | $22.5 million | $28.1 million |
The total cash burn from operating activities for the nine months ended September 30, 2025, was $23.2 million. This is a key metric for understanding how quickly the company was using its cash reserves.
The R&D spend reduction year-over-year is notable, but it reflects a strategic shift, not necessarily a reduction in core scientific commitment. The costs associated with clinical trial execution and manufacturing for their key programs are embedded within these figures, especially as they prepared for later-stage studies.
- Clinical trial execution and manufacturing costs for Phase 2/3-ready programs, particularly for amezalpat, drove R&D spending in prior periods.
- The R&D expense for the quarter ended September 30, 2025, was only $0.6 million, a sharp drop from $7.6 million in the same quarter of 2024.
- General and Administrative (G&A) expenses for the quarter were $3.0 million, flat compared to the prior year's quarter.
You can see the impact of the strategic review directly in the expense lines. The company was actively managing its cash burn by re-prioritizing efforts, which directly affected R&D spending.
- Costs associated with exploring strategic alternatives and financial advisory fees are captured within G&A and potentially impact R&D spending due to re-prioritization.
- The $5.6 million decrease in year-to-date R&D expenses was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
- Q3 2025 G&A expenses were primarily related to consulting and professional services, which often includes costs for strategic advisory work.
The G&A for the nine months ended September 30, 2025, at $10.4 million, was flat compared to the same period in 2024, primarily related to employee compensation costs, inclusive of one-time separation costs, as well as consulting and professional services.
Finance: draft 13-week cash view by Friday.
Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Revenue Streams
You're looking at the current financial reality for Tempest Therapeutics, Inc. (TPST) as of late 2025. For a clinical-stage biotech, revenue streams are almost entirely non-operational right now; it's all about capital formation and deal structure. Honestly, the numbers reflect a company heavily reliant on external funding to push its pipeline forward.
Currently, no product sales revenue as a clinical-stage company.
As of the third quarter ending September 30, 2025, Tempest Therapeutics reported zero revenue from product sales. This isn't surprising for a company deep in clinical development. The reported revenue for the trailing 12 months ending September 30, 2025, was exactly $0.00. Similarly, the annual revenue for the last reported fiscal year, 2024, was also $0.00.
This means all current financial inflows are from financing activities or potential future deal structures.
Proceeds from equity financing, including at-the-market (ATM) offerings.
Tempest Therapeutics, Inc. has been active in raising capital through equity offerings to extend its operational runway. You can see the recent activity below, which highlights the reliance on selling shares to fund operations, especially given the strategic pivot to explore alternatives.
| Financing Event/Period | Gross Proceeds (Approximate) | Net Proceeds Reported (If Available) | Date/Period |
| Registered Direct Offering (November 2025) | $4.25 million | N/A (Closed post-quarter) | November 2025 |
| Concurrent Warrants (November 2025 Offering) | Potential additional $4.1 million | N/A | November 2025 |
| At-The-Market (ATM) Offering Program | N/A | $2.8 million | Q3 2025 |
| Registered Direct Offering | $4.6 million | $4.1 million | June 2025 |
The November 2025 registered direct offering involved selling 1,172,414 shares at $3.625 per share, with warrants exercisable at $3.50 per share. The June 2025 offering raised $4.6 million by selling 739,000 shares at $6.25 per share. It's clear that these equity raises are a primary, near-term revenue source to cover operating cash burn.
Potential future revenue from an acquisition or merger transaction.
The most significant potential future value event discussed late in 2025 is the all-stock acquisition of certain dual-CAR T programs from Factor Bioscience Inc. This isn't a direct cash revenue stream, but it fundamentally alters the company's asset base and future value proposition. To close this deal, expected in early 2026, Tempest Therapeutics, Inc. will issue 8,268,495 new common shares to Factor Bioscience. This issuance represents approximately 65% of outstanding shares post-closing, indicating a substantial shift in ownership structure.
This transaction is contingent on a pre-closing equity financing securing at least $5.0 million in gross proceeds by December 5, 2025. If that financing condition is not met, the agreement can be terminated, and Tempest may owe a $300,000 termination fee.
Potential future revenue from upfront payments and milestones from a licensing deal.
While the Factor acquisition is structured as an all-stock deal, the strategic rationale points directly to future milestone-based revenue potential. The acquisition is explicitly stated to extend the Company's runway to mid-2027, potentially through value-creating milestones associated with the acquired pipeline assets, like TPST-2003. The company also plans to pursue business development discussions or an additional financing to advance the pivotal development of amezalpat (TPST-1120).
The expected milestones tied to the acquired programs include data readouts in 2026 and a Biologics License Application (BLA) in China planned for 2027. Any successful licensing of these or other pipeline assets would then generate upfront payments and subsequent milestone payments, which are the typical non-dilutive revenue drivers for a company at this stage. Right now, these are purely potential, not booked, revenue.
Finance: draft 13-week cash view by Friday.
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