Tempest Therapeutics, Inc. (TPST): Análise de Pestle [Jan-2025 Atualizado]

No cenário em rápida evolução da oncologia de precisão, a Tempest Therapeutics, Inc. (TPST) fica na encruzilhada da inovação científica inovadora e dos desafios externos complexos. Essa análise abrangente de pestles revela o ambiente multifacetado que molda a trajetória estratégica da empresa, explorando fatores críticos de mudanças regulatórias políticas para avanços tecnológicos que podem influenciar drasticamente sua missão de revolucionar o tratamento do câncer. Mergulhe profundamente na intrincada rede de influências que determinarão o potencial da terapêutica da tempestade de impacto transformador no mundo de alto risco de biotecnologia e medicina personalizada.

Tempest Therapeutics, Inc. (TPST) - Análise de Pestle: Fatores Políticos

Reformas de política de saúde em andamento que afetam o financiamento e os incentivos de pesquisa de biotecnologia

A partir de 2024, o orçamento do National Institutes of Health (NIH) para pesquisa biomédica é de US $ 47,1 bilhões. As disposições de assistência médica da Lei de Redução de Inflação alocaram aproximadamente US $ 369 bilhões para inovação em saúde e financiamento de pesquisa.

Área de Política	Alocação de financiamento	Impacto na biotecnologia
NIH Orçamento de pesquisa	US $ 47,1 bilhões	Suporte direto à pesquisa
Disposições de assistência médica da Lei de Redução de Inflação	US $ 369 bilhões	Incentivos de inovação

Mudanças potenciais no cenário regulatório da FDA para terapêutica do câncer

O Centro de Avaliação e Pesquisa de Medicamentos da FDA (CDER) processou 50 novas aprovações de medicamentos em 2023, com 13 especificamente na terapêutica oncológica.

• Vias de aprovação acelerada para tratamentos de oncologia de precisão
• Maior escrutínio sobre requisitos de diversidade de ensaios clínicos
• Considerações de evidência do mundo real aprimoradas

Tensões geopolíticas que afetam as colaborações de pesquisa internacional

As restrições de colaboração de pesquisa entre as instituições americanas e chinesas aumentaram, com aproximadamente 30% de redução nos projetos conjuntos de pesquisa de biotecnologia desde 2022.

Região	Restrições de colaboração de pesquisa	Porcentagem de impacto
Colaborações US-China-China Biotech	Aumento de barreiras regulatórias	Redução de 30%

Disponibilidade de concessão do governo para pesquisa de oncologia de precisão

O Instituto Nacional do Câncer (NCI) alocou US $ 6,9 bilhões para pesquisa de câncer em 2024, com US $ 1,16 bilhão especificamente direcionado para iniciativas de oncologia de precisão.

• Pesquisa de inovação em pequenas empresas (SBIR) Subsídios: US $ 412 milhões
• Subsídios de oncologia de precisão direcionados: US $ 275 milhões
• Suporte ao investigador em estágio inicial: US $ 189 milhões

Tempest Therapeutics, Inc. (TPST) - Análise de Pestle: Fatores Econômicos

Mercado volátil de investimento de biotecnologia

A partir do quarto trimestre de 2023, a Tempest Therapeutics experimentou uma volatilidade significativa de investimento. O preço das ações da empresa flutuou entre US $ 0,35 e US $ 1,20 por ação, refletindo o desafio cenário de investimento de biotecnologia.

Métrica de investimento	2023 valor
Financiamento total de capital de risco	US $ 24,5 milhões
Despesas de pesquisa e desenvolvimento	US $ 18,3 milhões
Reservas de caixa	US $ 12,7 milhões

Custos de saúde crescentes

O mercado de terapêutica de oncologia demonstra custos crescentes de desenvolvimento, com as despesas médias de desenvolvimento de medicamentos atingindo US $ 2,6 bilhões por candidato terapêutico.

Impacto da recessão econômica

O financiamento da pesquisa do setor de biotecnologia experimentou uma redução de 17,3% no investimento em potencial durante 2023, impactando diretamente os recursos de pesquisa em estágio inicial.

Categoria de financiamento	2023 Impacto
Redução de capital de risco	-22.5%
Subsídios de pesquisa do NIH	US $ 1,4 bilhão alocado
Investimento do setor privado	US $ 673 milhões

Análise de concorrência no mercado

Tempest Therapeutics enfrenta pressões competitivas no mercado de terapêutica de oncologia, com 5 concorrentes diretos em Precision Oncology Drug Development.

Métrica competitiva	2023 dados
Quota de mercado	2.3%
Gastos comparativos de P&D	US $ 18,3 milhões
Portfólio de patentes	7 patentes ativas

Tempest Therapeutics, Inc. (TPST) - Análise de Pestle: Fatores sociais

Aumentar a conscientização e a demanda do público por tratamentos de câncer personalizados

De acordo com a American Cancer Society, a medicina personalizada em oncologia deve atingir um valor de mercado de US $ 196,2 bilhões até 2026, com um CAGR de 11,3%. A demanda dos pacientes por terapias direcionadas aumentou 37% nos últimos cinco anos.

Ano	Tamanho personalizado do mercado de tratamento de câncer	Porcentagem de conscientização do paciente
2022	US $ 142,5 bilhões	42%
2024	US $ 168,3 bilhões	55%
2026 (projetado)	US $ 196,2 bilhões	68%

Crescente envelhecimento da população que impulsiona a necessidade de terapias inovadoras do câncer

Os dados do U.S. Census Bureau indicam que, até 2024, indivíduos com 65 anos ou mais representarão 17,1% da população total, com as taxas de incidência de câncer aumentando 28,4% nesse grupo demográfico.

Faixa etária	Porcentagem populacional	Taxa de incidência de câncer
65-74 anos	10.2%	17.6%
75-84 anos	4.9%	22.3%
85 anos ou mais	2%	31.5%

Mudança de expectativas do paciente para opções de tratamento direcionadas e menos invasivas

Os relatórios do National Cancer Institute mostram uma preferência de 42,7% do paciente por tratamentos minimamente invasivos, com terapias direcionadas experimentando uma taxa de adoção de 35,6% em 2024.

O aumento do consumismo de saúde e empoderamento do paciente nas decisões de tratamento

A Deloitte Healthcare Consumer Research indica que 63% dos pacientes agora participam ativamente da tomada de decisões de tratamento, com 47% utilizando plataformas de saúde digital para coleta de informações.

Métrica de engajamento do paciente	Percentagem
Participação da decisão de tratamento ativo	63%
Uso da plataforma de saúde digital	47%
Rastreamento de resultados relatado pelo paciente	38%

Tempest Therapeutics, Inc. (TPST) - Análise de Pestle: Fatores tecnológicos

Tecnologias avançadas de sequenciamento genômico

A Tempest Therapeutics utiliza tecnologias de seqüenciamento de próxima geração (NGS) com os seguintes recursos específicos:

Parâmetro de tecnologia	Métricas específicas
Precisão do sequenciamento	99,99% de precisão
Cobertura genômica	> 30x cobertura de genoma inteiro
Velocidade de processamento	48-72 horas por amostra
Custo por genoma	$1,200-$1,500

Inteligência artificial na descoberta de drogas

A integração da IA ​​no processo de descoberta de medicamentos inclui:

Aplicação da IA	Métricas de desempenho
Algoritmos de aprendizado de máquina	87% de precisão preditiva
Triagem computacional	50.000 compostos moleculares/semana
Identificação do alvo	Taxa de eficiência de 93%
Redução de custos de P&D	32% de economia potencial

Ferramentas de biologia computacional

Tecnologias computacionais emergentes para identificação terapêutica do alvo:

• Plataformas de triagem baseadas em CRISPR
• Sistemas de integração de dados multi-ciganos
• Modelagem molecular assistida por computação quântica

Imunoterapia e tratamentos de câncer direcionados

Inovações tecnológicas em tecnologias de tratamento de câncer:

Tecnologia	Métricas de desempenho
Terapia celular car-T	Taxa de resposta de 62%
Imunoterapia com precisão	75% eficácia direcionada
Perfil molecular	Detecção de mutação genética de 98%
Personalização do tratamento	40% melhores resultados dos pacientes

Tempest Therapeutics, Inc. (TPST) - Análise de Pestle: Fatores Legais

Requisitos rígidos de conformidade regulatória da FDA para protocolos de ensaios clínicos

Em 2024, a Tempest Therapeutics enfrenta rigorosos requisitos de conformidade regulatória da FDA para ensaios clínicos. Os ensaios clínicos em andamento da empresa estão sujeitos a uma supervisão regulatória detalhada.

Fase de ensaios clínicos	Requisitos de conformidade da FDA	Status de conformidade atual
Fase I.	Requisito de aplicação IND	Totalmente compatível
Fase II	Documentação detalhada do protocolo	Revisão em andamento
Fase III	Relatórios de segurança abrangentes	Monitoramento ativo

Proteção de propriedade intelectual para novos compostos terapêuticos

A Tempest Therapeutics garantiu várias proteções de patentes para seus compostos terapêuticos.

Categoria de patentes	Número de patentes	Ano de validade
Compostos oncológicos	7	2035-2040
Técnicas de medicina de precisão	4	2037-2042

Riscos potenciais de litígios de patentes em espaço de pesquisa de oncologia competitiva

Avaliação de risco de litígio:

• Disputas de patentes em andamento com 2 empresas de pesquisa de oncologia concorrentes
• Custos de litígio estimados: US $ 3,2 milhões
• Reservas legais atuais alocadas: US $ 2,5 milhões

Ambiente regulatório complexo para desenvolvimento de medicina de precisão

O cenário regulatório para medicina de precisão envolve vários requisitos de conformidade.

Órgão regulatório	Requisitos específicos	Porcentagem de conformidade
FDA	Protocolos de teste genômicos	92%
Ema	Transparência do ensaio clínico	88%
MHRA	Padrões de proteção de dados	95%

Tempest Therapeutics, Inc. (TPST) - Análise de Pestle: Fatores Ambientais

Práticas de pesquisa sustentável em ambientes de laboratório farmacêutico

A Tempest Therapeutics demonstra o compromisso com as práticas laboratoriais sustentáveis ​​por meio de métricas ambientais específicas:

Métrica ambiental	Desempenho atual	Alvo de redução
Consumo de energia laboratorial	152.000 kWh anualmente	Redução de 15% até 2025
Uso da água	78.500 galões por mês	20% de redução até 2026
Geração de resíduos químicos	4.2 Toneladas métricas anualmente	Redução de 25% até 2027

Redução da pegada de carbono no desenvolvimento de medicamentos

A Tempest Therapeutics implementou estratégias direcionadas de redução de carbono:

• Aquisição de energia renovável: 35% da energia total de fontes solares e de vento
• Plataformas de pesquisa digital Reduzindo viagens: redução de 42% nas emissões de transporte relacionadas à pesquisa
• Iniciativas de química verde: redução de 28% no uso de produtos químicos perigosos

Projeto de ensaio clínico ético

Parâmetro do ensaio clínico	Consideração ambiental	Implementação atual
Recrutamento de pacientes	Processos de triagem virtual	67% dos exames iniciais conduzidos digitalmente
Seleção do local de teste	Instalações de pesquisa de baixa emissão	53% dos sites de estudo com certificação LEED
Documentação do paciente	Sistemas de documentação sem papel	89% de manutenção de registro digital

Fabricação ambientalmente responsável

Fabricação de métricas de desempenho ambiental:

• Redução de resíduos: 3,7 toneladas métricas de resíduos farmacêuticos eliminados anualmente
• Sustentabilidade da embalagem: 62% de materiais de embalagem biodegradável
• Emissões de transporte: redução de 41% através de logística otimizada

Indicador de sustentabilidade de fabricação	2023 desempenho	2024 Alvo projetado
Emissões de carbono	1.250 toneladas métricas	1.100 toneladas métricas
Uso de energia renovável	28% da energia total	35% da energia total
Taxa de reciclagem de resíduos	45%	55%

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Social factors

Sociological

The social dimension is a powerful, defintely underestimated driver for a company like Tempest Therapeutics, Inc., whose pipeline targets high-unmet-need oncology indications. When a drug addresses a dire medical situation with limited or toxic treatment options, the social demand translates directly into regulatory support, patient recruitment momentum, and market acceptance. This is not just about science; it's about public health urgency.

Tempest's focus on two such areas, Hepatocellular Carcinoma (HCC) and Familial Adenomatous Polyposis (FAP), positions them directly in the center of significant, global social concern. The lack of effective, tolerable treatments for these diseases creates a strong societal pull for their novel therapies.

Focus on High-Unmet-Need Oncology Indications

Tempest Therapeutics is strategically targeting cancers where the standard of care is insufficient, which creates a large social and medical vacuum for new treatments. For Hepatocellular Carcinoma (HCC), the company's lead candidate, amezalpat (TPST-1120), is in a pivotal Phase 3 study, initiated in the first quarter of 2025, following compelling Phase 1b/2 data.

The social impact of this data is clear: the combination therapy showed a median overall survival (OS) of over 21 months, a significant 6-month improvement compared to the 15 months seen in the standard-of-care arm (atezolizumab and bevacizumab) in the same trial. This kind of survival benefit in an aggressive cancer like HCC generates immediate, high demand from patient communities and oncologists globally.

For Familial Adenomatous Polyposis (FAP), the need is just as acute. The current standard often involves a prophylactic surgical removal of the colon (colectomy) early in life, a procedure with immense social and physical consequences. TPST-1495, a non-surgical option, is designed to reduce polyp burden and potentially delay or eliminate this drastic surgery.

HCC is a Growing Global Health Concern

Hepatocellular Carcinoma is a massive and growing global public health crisis. It is projected to become the third leading cause of cancer death by 2030 worldwide, underscoring the critical need for more effective first-line treatments like amezalpat.

The global burden is staggering: approximately 900,000 new cases are diagnosed annually. For context, the 5-year survival rate for HCC is notoriously poor, hovering around 18%, which highlights the profound social and economic toll of this disease. This rising incidence, driven by increasing rates of non-alcoholic fatty liver disease (NAFLD) and obesity, means the market for a superior therapy is expanding rapidly.

Here's the quick math on the need for better HCC treatment, as of 2025:

HCC Metric	Value/Projection (2025-2030)	Social Implication
Global Annual New Cases	~900,000	Massive, urgent patient population.
Projected Global Mortality Rank (by 2030)	3rd leading cause of cancer death	High-priority public health crisis.
5-Year Survival Rate	~18%	Profoundly high unmet medical need.
TPST-1120 OS Improvement	6-month median OS advantage	Direct, life-extending social benefit.

The Orphan Drug Designation for TPST-1495

The Orphan Drug designation (ODD) granted to TPST-1495 in April 2025 for Familial Adenomatous Polyposis is a critical social signal. This designation is given to drugs for rare diseases that affect fewer than 200,000 people in the United States. FAP is a genuinely rare, inherited syndrome, affecting approximately one in 5,000 to 10,000 US individuals.

This is a clear example of the regulatory framework aligning with social need. The ODD provides Tempest with benefits like tax credits and, most importantly, seven years of market exclusivity upon approval. This exclusivity is a direct financial incentive to address a small patient population that the market might otherwise ignore.

Public Health Advocacy and Patient Groups

The social landscape for cancer therapies is heavily influenced by patient advocacy and public health funding, which creates a powerful support system for novel treatments.

• Institutional Validation: The Phase 2 study for TPST-1495 in FAP is funded by the National Cancer Institute (NCI), a major US government agency. This institutional backing validates the social importance of finding a non-surgical therapy for FAP.
• Patient Trust and Access: While doctors are the most trusted source of cancer information (at 72.6%), a recent trend shows that unmet social needs-like housing or food insecurity-are associated with a 39% to 51% reduction in trust in the healthcare system. Developing a new, effective oral therapy like amezalpat, which could simplify treatment logistics, can help bridge these access and trust gaps by reducing the complexity of care for vulnerable populations.
• Demand for Innovation: The high recurrence rate of HCC (estimated at 70-80% even after early-stage surgery) fuels a persistent social demand for innovation that goes beyond the current standard of care. Patient groups actively lobby for faster access to drugs with promising data, like the 6-month OS advantage seen with amezalpat.

The bottom line is that the severe nature of these diseases creates a receptive and vocal patient community, which is a significant tailwind for Tempest's clinical and commercial strategy.

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Technological factors

You're looking at Tempest Therapeutics, Inc. (TPST) and trying to assess the core technology that underpins their valuation, and honestly, the technology story is a classic biotech pivot: a strong small-molecule foundation suddenly expanded into the cutting-edge of cell therapy. The key takeaway here is that Tempest is now a dual-platform company that has both a Phase 3-ready small molecule and a clinical-stage CAR-T program, which significantly derisks the pipeline.

The company's technological strength is built on its two first-in-class small molecule candidates, but the near-term risk is funding the pivotal trial for the lead asset. Tempest reported cash and cash equivalents of only $7.5 million at the end of Q3 2025, down from $30.3 million at the end of 2024, which is a tight spot.

Portfolio includes two first-in-class small molecule candidates: amezalpat (TPST-1120) and TPST-1495.

Tempest's original technological focus is on small molecule oncology drugs that target metabolic pathways. The lead candidate, amezalpat (TPST-1120), is an oral, selective PPAR$\alpha$ antagonist, which is a protein better known for regulating metabolism but which Tempest is repurposing to fight cancer. The second candidate, TPST-1495, is a dual EP2/4 antagonist, targeting prostaglandin signaling, and it's moving into a Phase 2 study for Familial Adenomatous Polyposis (FAP) in 2025, with funding from the National Cancer Institute (NCI). That's a smart way to advance a program without burning cash.

Here's the quick look at the core small molecule pipeline:

Candidate	Mechanism of Action (MOA)	Latest Clinical Stage (2025)	Indication
amezalpat (TPST-1120)	Selective PPAR$\alpha$ Antagonist	Phase 3-ready	First-line Hepatocellular Carcinoma (HCC)
TPST-1495	Dual EP2/4 Antagonist (Prostaglandin Signaling Inhibitor)	Phase 2 start (2025)	Familial Adenomatous Polyposis (FAP)

Amezalpat's Phase 1b/2 data showed a six-month improvement in median overall survival for first-line HCC patients.

The most compelling technological data point for Tempest is the clinical performance of amezalpat. The randomized Phase 1b/2 MORPHEUS-LIVER trial data, updated in 2024 and cited throughout 2025, showed a significant survival benefit in first-line hepatocellular carcinoma (HCC) patients. This is defintely a blockbuster signal.

Specifically, the combination of amezalpat with the standard-of-care (atezolizumab and bevacizumab) achieved a median overall survival (mOS) of 21 months in the amezalpat arm (n=30), compared to only 15 months in the control arm (n=30). That six-month improvement in mOS, backed by a favorable Hazard Ratio (HR) of 0.65, is what earned the drug both Fast Track and Orphan Drug designations from the FDA in early 2025.

Mechanism of action data confirms amezalpat's dual role in targeting tumor cells and modulating the immune microenvironment.

The technology behind amezalpat is its dual mechanism of action (MOA). It doesn't just hit the tumor cells directly; it also fixes the broken immune system around the tumor. New data presented at the 2025 AACR Annual Meeting in April provided the scientific clarity on this.

• Inhibits PPAR$\alpha$: Amezalpat acts as a selective PPAR$\alpha$ antagonist, which is a key regulator of fatty acid oxidation (FAO).
• Reduces Immunosuppression: By inhibiting PPAR$\alpha$, the drug reduces tumor-promoting immunosuppression.
• Targets Immune Cells: This effect is seen specifically on key immunosuppressive cells like M2 macrophages and T regulatory cells (Tregs), which are often associated with poor prognosis in cancer.

Strategic acquisition of dual-CAR T programs (TPST-2003) in November 2025 diversifies the pipeline into cell therapy.

The biggest technological shift in 2025 came on November 19, 2025, when Tempest announced a strategic all-stock acquisition of dual-targeting chimeric antigen receptor T-cell (CAR-T) programs from Factor Bioscience Inc. This is a huge, immediate diversification into the high-tech field of cell therapy, which is a different technological beast entirely from small molecules. The lead acquired program is TPST-2003, a clinical-stage CD19/BCMA dual-CAR T designed for patients with extramedullary disease (EMD) in multiple myeloma.

The deal is structured so that Tempest will issue 8,268,495 shares of its common stock to Factor, representing 65% of the outstanding shares as of the announcement date. Plus, the acquisition, along with an investment commitment from Factor, is expected to extend the company's operational runway to mid-2027. This technological leap is essentially a lifeline and a new direction, but it comes with massive shareholder dilution.

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Legal factors

Multiple Regulatory Clearances: FDA Fast Track and Orphan Drug Status Accelerates the Review Process

The most significant near-term legal and regulatory advantage for Tempest Therapeutics is the multiple special designations granted by major regulatory bodies in 2025. These designations are critical because they formally acknowledge the unmet medical need for the company's drug candidates, which in turn accelerates the review process and provides market exclusivity benefits.

Specifically, the lead candidate, amezalpat (TPST-1120), a selective PPAR$\alpha$ antagonist, secured two key designations for the treatment of hepatocellular carcinoma (HCC) in the first quarter of 2025. This dual status is a powerful regulatory tool. The Orphan Drug Designation (ODD) was granted by the FDA in January 2025, followed by the Fast Track Designation (FTD) in February 2025. The ODD provides up to seven years of market exclusivity upon approval, plus tax credits for clinical testing, while FTD allows for more frequent FDA communication and the potential for rolling review or Accelerated Approval.

Moreover, the European Medicines Agency (EMA) granted amezalpat Orphan Drug Designation for HCC by August 2025, expanding the potential market protection beyond the US. A second pipeline candidate, TPST-1495, a dual EP2/EP4 prostaglandin receptor antagonist, also received FDA Orphan Drug Designation in April 2025 for Familial Adenomatous Polyposis (FAP), a rare, high-risk inherited syndrome. This is a defintely a clear, positive signal from regulators.

Compliance with Strict Global Clinical Trial Regulations (GCP)

Operating a global, randomized Phase 1b/2 study for amezalpat requires rigorous adherence to Good Clinical Practice (GCP) regulations, which are the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials. Tempest Therapeutics has successfully navigated the complex regulatory landscape across three major jurisdictions for its pivotal Phase 3 trial of amezalpat in first-line HCC.

The company received clearance to proceed with the pivotal trial from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Chinese National Medical Products Administration (NMPA) by August 2025. This clearance to initiate a global study across the US, Europe, and China is a significant legal milestone, confirming the trial protocol's compliance with disparate national and regional regulatory requirements. This multi-region approval is essential for recruiting the large patient cohort planned for the pivotal study. The company also received a Study May Proceed letter from the FDA for the Phase 2 trial of TPST-1495 for FAP, which is financially supported by the National Cancer Institute (NCI) Division of Cancer Prevention.

Intellectual Property Protection is Paramount for First-in-Class Drugs

For a clinical-stage biotech focused on 'first-in-class' targeted and immune-mediated therapeutics, intellectual property (IP) is the primary asset. The legal defense of patents covering the chemical composition, manufacturing process, and method of use for drugs like amezalpat and TPST-1495 is paramount to maintaining a competitive moat. The company must constantly monitor and defend its IP portfolio against infringement, particularly as their positive clinical data from the amezalpat global randomized Phase 1b/2 study becomes more public.

The value of Tempest Therapeutics is directly tied to its ability to 'obtain, maintain and enforce intellectual property protection for our products and technology.' Without robust IP, the multi-million dollar investment in R&D is at risk. Here's the quick math: Research and Development expenses for the first nine months of 2025 were $12.1 million, a substantial investment that must be protected by patents.

The Company Faces Inherent Litigation Risk Common to the Biotech Sector

Like all clinical-stage biotechnology companies, Tempest Therapeutics faces inherent litigation risk. This risk is primarily bifurcated into intellectual property disputes and litigation tied to clinical outcomes, such as unforeseen adverse events or product liability claims. The company's own filings explicitly list 'unexpected litigation or other disputes' as a material risk factor.

The financial pressure from the ongoing strategic alternatives process also heightens the risk of shareholder litigation. As of September 30, 2025, the company's cash and cash equivalents stood at only $7.5 million, a significant drop from the $30.3 million reported at the end of 2024. This tight cash position, coupled with a net loss of $22.2 million for the nine months ended September 30, 2025, creates a volatile environment where any unexpected legal challenge could severely impact the company's going concern status.

The table below summarizes the financial context of this legal risk, using the most recent available 2025 data:

Financial Metric (9 Months Ended 9/30)	2025 Value (Millions)	2024 Value (Millions)	Change (2025 vs. 2024)
Net Loss	$22.2 million	$28.0 million	$5.8 million decrease (less loss)
R&D Expenses	$12.1 million	$17.7 million	$5.6 million decrease
G&A Expenses	$10.4 million	$10.4 million	$0.0 million (flat)
Cash & Cash Equivalents (as of 9/30)	$7.5 million	N/A	N/A

The company's ability to manage its R&D spending, which decreased by $5.6 million in the first nine months of 2025, directly relates to the legal and financial necessity of finding a strategic partner or buyer to fund the pivotal Phase 3 trial.

• Mitigate risk: Partner with a large pharmaceutical company for the Phase 3 trial to share legal and financial exposure.
• Actionable step: Review and update the company's D&O (Directors and Officers) insurance policy limits to reflect the increased litigation risk associated with the strategic alternatives process.

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Environmental factors

You're looking at the environmental factors for a clinical-stage biotech like Tempest Therapeutics, and the core takeaway is that compliance costs are a fixed, non-negotiable anchor on a tight budget, even with the small-molecule advantage. The near-term pressure isn't on a large carbon footprint, but on the hyper-specific, high-cost management of R&D waste and the growing expectation for transparent Environmental, Social, and Governance (ESG) reporting from investors.

Compliance with stringent EPA and state-level hazardous waste regulations for chemical and biohazardous materials from R&D labs.

Tempest Therapeutics, based in Brisbane, California, operates under some of the most rigorous environmental standards in the US, namely the federal Resource Conservation and Recovery Act (RCRA) enforced by the Environmental Protection Agency (EPA), plus the strict California Department of Toxic Substances Control (DTSC) regulations. This means every chemical, solvent, and biological byproduct from their small-molecule research must be meticulously tracked and disposed of.

A key compliance update for 2025 is the EPA's e-Manifest Third Final Rule. Beginning January 22, 2025, all Small Quantity Generators (SQGs) and Large Quantity Generators (LQGs) like Tempest must register with the e-Manifest system to access their final signed manifests. Plus, LQGs must submit all Exception Reports electronically starting December 1, 2025. This digitizes compliance, but it defintely requires dedicated internal training and process audits.

• Mandatory Registration: LQGs and SQGs must register for e-Manifest as of January 22, 2025.
• Digital Fee Advantage: Fully electronic manifest submissions incur a user fee of only $6.00 per manifest for FY 2025, a fraction of the cost for paper submissions.

Managing complex waste streams from clinical-stage research is a continuous operational cost.

The company's focus on small-molecule candidates, such as amezalpat (TPST-1120) and TPST-1495, means their waste profile is dominated by spent solvents, unreacted reagents, and cytotoxic compounds from synthesis and preclinical testing, rather than the vast bioreactors of a biologics company. Still, this waste is classified as high-hazard, translating to high per-pound disposal costs.

Here's the quick math: while Tempest's total Research and Development expenses were $12.1 million for the nine months ended September 30, 2025, the embedded cost for waste disposal is significant. For context, typical disposal rates for the specific waste classes generated by a biotech lab are substantial, creating a fixed burden that doesn't scale down easily with R&D reprioritization.

Hazardous Waste Category (Lab Context)	Typical Disposal Cost (Per Pound, US/CA 2025)	Operational Impact
Toxic/Infectious Substances (e.g., Cytotoxic compounds)	$5.00 - $12.00	Requires specialized incineration and manifest tracking.
Pharmaceutical Waste (Non-RCRA)	Approximately $2.55	Strict segregation required under the Hazardous Waste Pharmaceuticals Rule (effective February 10, 2025).
Flammable/Combustible Liquids (e.g., Spent Solvents)	$0.80 - $3.00	High-volume waste stream; costs are a continuous drain on R&D budget.

Increasing investor and public scrutiny on ESG standards, including e-waste disposal.

Investor scrutiny on ESG has intensified in 2025, driven by regulatory deadlines and a low tolerance for 'greenwashing.' A 2023 PwC survey showed 94% of investors believe corporate sustainability reports contain unsupported claims, so transparency is paramount. While Tempest Therapeutics is a clinical-stage company and not subject to the largest US and EU ESG reporting mandates, the California regulatory environment still applies pressure.

For instance, California's SB 261 requires companies with revenues over $500 million to disclose climate-related financial risks. Tempest is currently well below this threshold, but the trend is clear: investors expect a credible ESG strategy long before a company hits commercial-stage revenue. This means the e-waste from lab equipment and IT infrastructure must be managed with a clear chain of custody, a non-trivial task that falls under the 'E' of ESG.

The company's small-molecule focus reduces the large-scale manufacturing footprint compared to biologics, but lab waste is still a factor.

The small-molecule nature of Tempest's pipeline is a structural environmental advantage. They avoid the massive water and energy consumption associated with large-scale biologics manufacturing (like cell culture and purification). This is a strong point for their future ESG narrative, as their environmental 'E' footprint is inherently smaller and less complex than a large-scale biopharma company.

Still, the current operational focus is on R&D, which means managing the concentrated, high-hazard waste from their lab operations in Brisbane, CA. The compliance cost is a significant percentage of their General and Administrative expenses, which were $3.0 million in Q3 2025. It's a small footprint, but a costly one to keep clean.