Terns Pharmaceuticals, Inc. (TERN): Análise de Pestle [Jan-2025 Atualizado]

No mundo dinâmico da inovação farmacêutica, a Terns Pharmaceuticals, Inc. (TERN) está em uma interseção crítica de avanços científicos e desafios globais complexos. Essa análise abrangente de pestles revela o cenário multifacetado que molda a tomada de decisão estratégica da empresa, explorando a intrincada rede de regulamentos políticos, flutuações econômicas, expectativas sociais, avanços tecnológicos, complexidades legais e considerações ambientais que definem o ecossistema de biotecnologia moderno. Desde a navegação nos labirintos regulatórios da FDA até os tratamentos pioneiros em doenças raras, a jornada de Tern reflete a profunda interconectividade da ambição científica e forças ambientais externas que podem fazer ou quebrar a inovação farmacêutica.

Terns Pharmaceuticals, Inc. (Tern) - Análise de Pestle: Fatores Políticos

Impacto potencial das políticas regulatórias da FDA dos EUA nos processos de aprovação de medicamentos

A partir de 2024, o processo de aprovação de drogas da FDA envolve várias métricas críticas:

Métrica da FDA	Valor atual
Tempo de revisão padrão	10 meses
Tempo de revisão prioritário	6 meses
Aprovações de designação de terapia inovadora	45 por ano

Alterações contínuas da política de saúde que afetam o financiamento da pesquisa farmacêutica

Alocação atual de financiamento federal de pesquisa para pesquisa farmacêutica:

• NIH Orçamento para pesquisa farmacêutica: US $ 42,9 bilhões em 2024
• SBIR/STTR Subsídios para biotecnologia: US $ 3,2 bilhões
• Financiamento de pesquisa rara -rara direcionada: US $ 1,5 bilhão

Tensões geopolíticas que influenciam colaborações internacionais de pesquisa farmacêutica

Região	Impacto de colaboração de pesquisa
Relações EUA-China	Redução de 35% em projetos de pesquisa conjunta
Colaboração EUA-UE	87% das parcerias de pesquisa existentes mantidas

A posição do governo dos EUA sobre inovação e apoio à pesquisa de biotecnologia

Métricas de suporte federal para inovação de biotecnologia em 2024:

• Créditos tributários para P&D: 20% das despesas qualificadas
• Subsídios de pesquisa direta: US $ 2,7 bilhões
• Aprovações rápidas regulatórias: 62 novas designações

Terns Pharmaceuticals, Inc. (TERN) - Análise de Pestle: Fatores Econômicos

Volatilidade nos mercados de investimentos de biotecnologia que afetam o financiamento da empresa

A partir do quarto trimestre 2023, a Terns Pharmaceuticals relatou dinheiro total e equivalentes em dinheiro de US $ 89,1 milhões. O mercado de investimentos em biotecnologia experimentou volatilidade significativa, com financiamento de capital de risco em biotecnologia diminuindo em 42% de 2022 para 2023.

Ano	Financiamento de capital de risco biotecnológico	Faixa de preço de estoque de Tern
2022	US $ 17,4 bilhões	$1.50 - $3.25
2023	US $ 10,1 bilhões	$0.75 - $2.10

Impacto das tendências de gastos com saúde em investimentos em pesquisa farmacêutica

Os gastos globais de pesquisa e desenvolvimento farmacêuticos atingiram US $ 238 bilhões em 2023, com um aumento de 3,5% em relação ao ano anterior. Terns Pharmaceuticals alocados US $ 24,3 milhões pesquisar e desenvolver em seu ano fiscal mais recente.

Desafios potenciais para garantir capital de risco para o desenvolvimento de medicamentos para doenças raras

Tendências de financiamento de desenvolvimento de doenças raras:

• Investimento total de doenças raras em 2023: US $ 6,7 bilhões
• Investimento médio por Programa de Doenças Raras: US $ 87,5 milhões
• Taxa de sucesso para desenvolvimento de medicamentos para doenças raras: 11,2%

Taxas de câmbio flutuantes que afetam os custos internacionais de pesquisa e desenvolvimento

Par de moeda	2022 Taxa de câmbio	2023 Taxa de câmbio	Variação percentual
USD/EUR	0.95	0.91	-4.2%
USD/CNY	6.89	7.11	+3.2%

Variações internacionais de custo de P&D devido a flutuações de taxa de câmbio estimadas em 7.5% para as iniciativas de pesquisa global da Terns Pharmaceuticals.

Terns Pharmaceuticals, Inc. (Tern) - Análise de Pestle: Fatores sociais

Crescente conscientização e demanda por soluções de tratamento de doenças raras

De acordo com a Organização Nacional de Distúrbios Raros (Nord), aproximadamente 30 milhões de americanos são afetados por doenças raras. O mercado global de tratamento de doenças raras foi avaliado em US $ 175,6 bilhões em 2022 e deve atingir US $ 268,3 bilhões até 2027.

Métricas do mercado de doenças raras	2022 Valor	2027 Valor projetado	Cagr
Tamanho do mercado global	US $ 175,6 bilhões	US $ 268,3 bilhões	8.9%

Aumentar a defesa do paciente para pesquisa farmacêutica inovadora

Os grupos de defesa dos pacientes cresceram significativamente, com mais de 7.000 organizações de pacientes com doenças raras nos Estados Unidos. Esses grupos apóiam ativamente o financiamento da pesquisa e os ensaios clínicos.

Métricas de defesa do paciente	Número
Organizações de pacientes com doenças raras em nós	7,000+
Financiamento anual de pesquisa por grupos de defesa	US $ 1,2 bilhão

Mudanças demográficas que afetam as populações de pacientes -alvo

A população envelhecida afeta significativamente os mercados de tratamento de doenças raras. Até 2030, 21% da população dos EUA terá 65 anos ou mais, aumentando potenciais populações de pacientes para tratamentos especializados.

Indicadores de mudança demográfica	2024 Projeção	2030 Projeção
População dos EUA com mais de 65 anos	17.3%	21%
Prevalência de doenças raras em idosos	45%	52%

Mudando as expectativas do consumidor de saúde para medicina personalizada

O mercado de medicina personalizada está experimentando um rápido crescimento. O mercado global de medicamentos personalizados foi estimado em US $ 493,73 bilhões em 2022 e deve atingir US $ 842,76 bilhões até 2030.

Mercado de Medicina Personalizada	2022 Valor	2030 Valor projetado	Cagr
Tamanho do mercado global	US $ 493,73 bilhões	US $ 842,76 bilhões	6.8%

Terns Pharmaceuticals, Inc. (TERN) - Análise de Pestle: Fatores tecnológicos

Capacidades avançadas de pesquisa de terapia genética e medicina de precisão

A Terns Pharmaceuticals investiu US $ 12,4 milhões em pesquisa de terapia genética a partir de 2023. O pipeline de medicina de precisão da empresa inclui 3 programas ativos de terapia genética direcionados a distúrbios genéticos raros.

Área de pesquisa	Investimento ($ m)	Programas ativos	Indicação alvo
Terapia genética	12.4	3	Distúrbios genéticos raros
Tecnologias Crispr	5.7	2	Oncologia

Inteligência artificial e integração de aprendizado de máquina na descoberta de medicamentos

A Terns Pharmaceuticals alocou US $ 8,2 milhões à IA e plataformas de descoberta de medicamentos para aprendizado de máquina em 2023. A pesquisa orientada pela AI da empresa reduziu os prazos de desenvolvimento de medicamentos em 37%.

Tecnologia da IA	Investimento ($ m)	Melhoria de eficiência	Aplicação -chave
Algoritmos de aprendizado de máquina	8.2	Redução da linha do tempo de 37%	Triagem molecular

Técnicas emergentes de biologia computacional para desenvolvimento de medicamentos

Os investimentos em biologia computacional atingiram US $ 6,5 milhões em 2023. A empresa aproveita modelos computacionais avançados para prever interações medicamentosas e otimizar estruturas moleculares.

Técnica computacional	Investimento ($ m)	Foco na pesquisa	Ferramentas computacionais
Modelagem preditiva	6.5	Previsão de interação com drogas	Plataformas de simulação avançada

Blockchain e tecnologias digitais transformando processos de ensaios clínicos

A Terns Pharmaceuticals investiu US $ 3,9 milhões em tecnologias de gerenciamento de blockchain e ensaios digitais em 2023. A transformação digital melhorou a integridade dos dados e a eficiência do recrutamento de pacientes em 28%.

Tecnologia digital	Investimento ($ m)	Melhoria de eficiência	Benefício principal
Ensaios clínicos de blockchain	3.9	28% de eficiência de recrutamento	Segurança de dados aprimorada

Terns Pharmaceuticals, Inc. (Tern) - Análise de Pestle: Fatores Legais

Proteção de propriedade intelectual complexa para novos compostos de drogas

A partir de 2024, a Terns Pharmaceuticals possui 7 pedidos de patente ativos relacionado ao seu pipeline de desenvolvimento de medicamentos. A carteira de propriedade intelectual da empresa cobre compostos em oncologia e tratamento de doenças hepáticas.

Tipo de patente	Número de patentes	Duração da proteção estimada
Composição da matéria	3	20 anos a partir da data de arquivamento
Método de uso	4	15-18 anos a partir da data de arquivamento

Conformidade com os requisitos regulatórios da FDA para ensaios clínicos

Em 2023, a Terns Pharmaceuticals enviou 3 Aplicações de medicamentos para investigação (IND) para o FDA. A conformidade do ensaio clínico da empresa envolve:

• Aderência a diretrizes de boa prática clínica (GCP)
• Documentação abrangente de protocolos de teste
• Monitoramento rigoroso de segurança do paciente

Fase de ensaios clínicos	Número de ensaios em andamento	Inscrição total do paciente
Fase I.	2	45 pacientes
Fase II	1	78 pacientes

Riscos potenciais de litígios de patentes em paisagem farmacêutica competitiva

A partir de 2024, os rostos de Terns Pharmaceuticals 2 desafios pendentes de oposição de patentes de empresas farmacêuticas concorrentes. Os custos de defesa legais para esses desafios são estimados em US $ 1,2 milhão.

Navegando estruturas regulatórias internacionais para o desenvolvimento de medicamentos

Terns Pharmaceuticals tem aprovações regulatórias em 4 mercados internacionais, incluindo Estados Unidos, União Europeia, Japão e Canadá.

Região	Agência regulatória	Status de aprovação
Estados Unidos	FDA	Conformidade regulatória total
União Europeia	Ema	Aprovação condicional
Japão	PMDA	Fase III Revisão
Canadá	Health Canada	Conformidade regulatória total

Terns Pharmaceuticals, Inc. (Tern) - Análise de Pestle: Fatores Ambientais

Práticas sustentáveis ​​em pesquisa e desenvolvimento farmacêutico

A Terns Pharmaceuticals implementou princípios de química verde, reduzindo o uso de solventes em 37% nos processos de pesquisa. As métricas de sustentabilidade de P&D da empresa para 2023 incluem:

Métrica de sustentabilidade	Valor quantitativo
Uso de energia renovável em laboratórios	42.6%
Taxa de reciclagem de água	28.3%
Redução de resíduos químicos	24.7%

Reduzindo a pegada de carbono em operações de laboratório e ensaios clínicos

Estratégias de redução de emissões de carbono implementadas pela Terns Pharmaceuticals:

• Alcançado 22,4% de redução no consumo de energia laboratorial
• Implementou componentes de ensaios clínicos virtuais, reduzindo as emissões relacionadas a viagens em 33%
• Utilizou equipamentos com eficiência energética com consumo de energia 45% menor

Métrica de pegada de carbono	2023 Medição
Emissões totais de CO2	1.247 toneladas métricas
Investimentos de compensação de carbono	US $ 2,3 milhões

Fornecimento ético de materiais de pesquisa e compostos farmacêuticos

Conformidade de sustentabilidade do fornecedor:

Categoria de fornecimento	Porcentagem de conformidade
Fornecedores ambientalmente certificados	67.9%
Compra de matéria -prima sustentável	53.4%
Fornecimento de ingrediente comercial justo	41.2%

Avaliações de impacto ambiental para processos de fabricação de medicamentos

Métricas de avaliação de impacto ambiental para fabricação:

Parâmetro de avaliação	2023 dados
Eficiência do tratamento de águas residuais	92.6%
Redução de resíduos perigosos	36.8%
Gasto de conformidade ambiental	US $ 4,7 milhões

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Social factors

High unmet medical need in relapsed/refractory Chronic Myeloid Leukemia (CML) drives TERN-701 focus

The core of Terns Pharmaceuticals' strategy is now anchored in addressing the significant social need in oncology, specifically for patients with relapsed/refractory Chronic Myeloid Leukemia (CML) who have failed prior treatments. This patient population has a high unmet medical need, which is a powerful social driver for new drug development.

The global CML market is valued at approximately $8.86 billion in 2025, and it is projected to grow to $12.07 billion by 2030, underscoring the demand for more effective, next-generation treatments. Terns' lead asset, TERN-701, an oral allosteric BCR-ABL inhibitor, is positioned to capture this need, especially for those resistant to established therapies like asciminib.

The latest clinical data from the Phase 1 CARDINAL trial, with a cutoff date of June 30, 2025, highlights this potential. For efficacy-evaluable patients, the overall (cumulative) Major Molecular Response (MMR) rate was a remarkable 75% by 24 weeks, with 100% of patients maintaining MMR at the data cutoff. This level of efficacy in heavily pre-treated patients directly addresses the social burden of treatment failure.

Public demand for weight loss drugs is massive, but Terns is exiting this highly competitive metabolic space

While public demand for weight loss drugs has created a massive market, Terns Pharmaceuticals is making the hard, realistic decision to exit this highly competitive metabolic space, a move announced after disappointing Phase 2 results in October 2025. This strategic pivot reflects a social factor-the intense public and market demand for highly efficacious therapies-that Terns could not meet with its current asset.

The oral GLP-1 receptor agonist, TERN-601, showed a maximum placebo-adjusted weight loss of only 4.6% at 12 weeks in its Phase 2 trial. Honestly, that result fell short of the company's internal target of 6% to 7%, making it uncompetitive against front-runners like Eli Lilly's orforglipron. The company will discontinue internal development of TERN-601 and other metabolic assets beyond year-end 2025, focusing its cash, which was $295.6 million as of September 30, 2025, entirely on oncology. That's a clear action based on a competitive social reality.

Patient-centric data and real-world evidence are increasingly important for regulatory approval

The social expectation for pharmaceutical companies is shifting; patients and regulators now demand that drug development incorporates the patient voice and real-world outcomes. This is the rise of patient-centric data and Real-World Evidence (RWE).

Regulatory bodies are increasingly accepting RWE to support drug approvals, a trend that is dominant in 2025. For oncology, a new Patient-Centered Real-World Evidence (PCRWE) Framework was proposed in November 2025 to guide the integration of patient perspectives into RWE research. Terns demonstrates alignment with this social trend by emphasizing its commitment to patient safety and thoughtful clinical trial design for the CARDINAL study, actively seeking to develop therapies that have fewer side effects and are more convenient.

• Patient-centric RWE is generated through wearables, mobile apps, and patient registries.
• The goal is to provide insights into patient-relevant questions and unmet needs.
• This social shift accelerates drug development and improves patient outcomes.

Increased investor focus on Environmental, Social, and Governance (ESG) standards globally

Investors are scrutinizing biotech companies not just for pipeline success, but also for their social impact, captured under Environmental, Social, and Governance (ESG) metrics. This is a non-negotiable social factor for attracting capital in 2025.

Terns Pharmaceuticals has a measurable social footprint. According to The Upright Project, the company has a net impact ratio of 58.8%, indicating an overall positive sustainability impact. This positive contribution is driven by core social value creation:

Social Impact Category	Contribution Type
Physical diseases	Positive (Developing treatments for serious diseases)
Creating knowledge	Positive (Research and development in biopharma)
Jobs	Positive (Employment and economic activity)
Scarce human capital	Negative (Resource use, e.g., highly specialized talent)
Equality & Human rights	Negative (Potential for negative impact, common for small biotechs)

The positive impact on 'Physical diseases' is a strong social selling point, directly linked to the CML program, but the negative impact in areas like 'Scarce human capital' shows a limit to their current social contribution that needs to be defintely managed.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Technological factors

You're looking at Terns Pharmaceuticals, Inc. (TERN) at a critical technological inflection point, a moment where the success of a single, small-molecule innovation dictates the company's entire future. The core technological factor here is the power of a highly-targeted, small-molecule drug to deliver best-in-class efficacy, but also the brutal reality that a similar small-molecule approach can fail against a rapidly advancing class of competitors, forcing a complete strategic pivot.

TERN-701 is a next-generation, allosteric BCR-ABL inhibitor, a key small-molecule innovation.

The company's technology bet is now entirely focused on TERN-701, an oral, allosteric BCR-ABL inhibitor for Chronic Myeloid Leukemia (CML). This is a precise, small-molecule innovation designed to overcome resistance to older tyrosine kinase inhibitors (TKIs), which is a huge technological hurdle in oncology. The Phase 1 CARDINAL trial data, released in late 2025, shows this technology is defintely competitive.

Here's the quick math on the potential: In heavily pre-treated CML patients, the overall (cumulative) Major Molecular Response (MMR) rate by 24 weeks reached an impressive 75% (24 out of 32 efficacy-evaluable patients). This level of response in a difficult-to-treat population suggests the drug has a best-in-class profile, which is the technological edge Terns Pharmaceuticals needs to compete with established TKI therapies.

Phase 1 data showed a 75% cumulative Major Molecular Response (MMR) rate by 24 weeks, suggesting best-in-class potential.

The technological sophistication of TERN-701 is evident in its ability to maintain efficacy in patients who failed prior treatments, including the next-generation TKI asciminib. The data is strong, and it's the primary driver of the company's valuation and strategic focus as of the end of 2025.

TERN-701 Phase 1 CARDINAL Trial Efficacy (24 Weeks)	Result	Technological Significance
Overall (Cumulative) MMR Rate	75% (24/32 patients)	High efficacy in a heavily pre-treated population.
MMR Rate in Patients with Prior Asciminib Failure	60% (6/10 patients)	Overcoming resistance to a competitor's advanced TKI.
Patients Remaining on Treatment (at data cutoff)	87% (48/55 patients)	Encouraging safety/tolerability profile for long-term use.

Discontinuation of TERN-601 (GLP-1 RA) after 4.6% weight loss data highlights high bar for new obesity tech.

The flip side of technological innovation is the high bar for market entry, especially in a crowded space like metabolic disease. Terns Pharmaceuticals made the strategic decision in October 2025 to discontinue internal clinical development of its oral GLP-1 receptor agonist (GLP-1 RA), TERN-601. The Phase 2 topline 12-week data showed a maximum placebo-adjusted weight loss of only 4.6%. This result was simply uncompetitive when compared to the 15%+ weight loss seen with leading injectable GLP-1s, and even fell short of the 5% to 7% internal expectations. The technology was not differentiated enough to justify the substantial R&D spend, which reached $19.9 million in the third quarter of 2025 alone.

Biopharma is increasingly adopting AI for clinical trial design and advanced diagnostics.

The broader technological landscape is being reshaped by Artificial Intelligence (AI) and advanced data analytics, an external factor Terns Pharmaceuticals must use to accelerate its TERN-701 program. The global market for AI in clinical trials is estimated to be valued at $1.77 billion in 2025, reflecting a major industry shift toward optimizing drug development. This technology is crucial for Terns as it moves TERN-701 into later-stage trials, where efficiency is paramount.

Terns Pharmaceuticals is essentially a small-molecule technology house, so it must embrace these digital advancements to stay competitive. The goal is to reduce trial costs by up to 70% and shorten timelines by as much as 80%, which is the kind of operational efficiency a focused oncology company needs. This is not just a trend; it's a necessity for survival.

• AI in biopharma is projected to generate $350 billion to $410 billion in annual value by 2025.
• AI spending in the pharmaceutical industry is expected to hit $3 billion in 2025.
• AI is primarily used to optimize trial design, improve patient recruitment, and monitor real-time data.

The next concrete step is for the Oncology R&D team to start a formal review of three AI-driven clinical trial optimization platforms by the end of the current quarter.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Legal factors

FDA's rigorous regulatory review process requires TERN-701 to meet the 6-month MMR endpoint for pivotal trial design.

The core legal and regulatory hurdle for Terns Pharmaceuticals' lead oncology asset, TERN-701 (for Chronic Myeloid Leukemia or CML), is meeting the U.S. Food and Drug Administration (FDA) standard for a pivotal trial. For CML, this standard is the achievement of a Major Molecular Response (MMR) at six months (24 weeks), which is the critical surrogate endpoint for accelerated approval.

The company's Phase 1 CARDINAL trial data, updated in November 2025, shows they are on track, which is defintely a risk mitigator. Specifically, the data presented at the ASH 2025 abstract showed an overall (cumulative) MMR rate of 75% by 24 weeks in heavily pre-treated patients. This is the number that will drive the design and cost of the subsequent, more expensive Phase 3 trial. The FDA's consistent requirement for this 6-month MMR benchmark means Terns must maintain this high efficacy signal in a larger patient population to move TERN-701 toward a New Drug Application (NDA).

Here's the quick math on their current financial position versus their R&D burn, which is directly tied to regulatory progression:

Financial Metric (Q3 2025)	Amount (in millions)
Cash, Cash Equivalents, and Marketable Securities (Sept 30, 2025)	$295.6 million
Research & Development (R&D) Expenses (Q3 2025)	$19.9 million
Net Loss (Q3 2025)	$24.6 million

What this estimate hides is the step-up in R&D costs when a pivotal trial starts, so the current quarterly R&D expense of $19.9 million will rise significantly as TERN-701 advances into a larger, global study.

Intellectual property (IP) protection is crucial for small-molecule drugs like TERN-701 against generics and competitors.

As a small-molecule drug, TERN-701 faces an elevated IP risk compared to biologics, as small molecules are generally easier to reverse-engineer and manufacture as generics once the primary patent expires. Terns Pharmaceuticals' strategy is to build a robust patent portfolio around the molecule itself, its formulation, and its use.

The company has secured and is pursuing multiple layers of protection to extend its market exclusivity, which is essential for maximizing return on its R&D investment. The goal is to secure a patent life that extends well beyond the typical 20-year term from filing.

• Issued patents and pending applications cover the drug's polymorphs (different crystalline forms), methods of treatment/dosing, and combination treatment approaches.
• The company can potentially extend its patent exclusivity for up to an additional 5 years through a Patent Term Extension (PTE) under the Hatch-Waxman Act, which compensates for time lost during the FDA review process.
• Current IP timelines for TERN-701 are projected to extend past 2040 in the U.S. and other key territories, providing a long commercial runway against generic competition.

This long IP runway is a major asset, but still, any challenge from a competitor or generic manufacturer (an Abbreviated New Drug Application or ANDA filing) would trigger costly, time-consuming litigation. That's a significant, albeit necessary, legal expense for a company with a quarterly General and Administrative (G&A) expense of $7.8 million as of Q3 2025.

Biosecure Act implications could force supply chain changes if Terns uses specified foreign contractors.

The legislative environment in late 2025, particularly the potential enactment of the Biosecure Act (as part of the National Defense Authorization Act for Fiscal Year 2026), creates a major legal risk for Terns' supply chain. This Act is designed to prohibit U.S. federal agencies from contracting with, or providing loans/grants to, entities that use biotechnology equipment or services from a 'biotechnology company of concern'-which often means companies linked to foreign adversaries.

If Terns Pharmaceuticals uses a Contract Development and Manufacturing Organization (CDMO) or a Contract Research Organization (CRO) that is later designated as a company of concern, the implications are immediate and severe, especially since Terns is a clinical-stage company that relies heavily on third parties for manufacturing and trials. If the Act is passed, its reach extends to subcontractors, CROs, and data-management vendors.

The key action for Terns is supply chain due diligence right now. They need to:

• Identify all third-party vendors (CDMOs, CROs, data platforms) with ties to the specified foreign entities.
• Develop a substitution plan for any at-risk contractors, because a sudden transition can cause drug development delays and increase manufacturing costs.
• Be aware that there is no grace period for contracts with entities already on the Department of Defense's 1260H List, meaning an abrupt termination of those relationships would be required upon enactment.

Increased scrutiny on data security and privacy for clinical trial data.

The legal landscape governing clinical trial data security and privacy has tightened significantly in 2025, increasing compliance costs and risk for Terns. This scrutiny comes from multiple directions: U.S. national security, public transparency, and general data privacy regulations like the European Union's General Data Protection Regulation (GDPR).

First, a Department of Justice (DOJ) rule, effective April 8, 2025, prohibits or restricts access to bulk sensitive personal data of U.S. persons by entities tied to countries of concern, though there are exemptions for FDA-regulated clinical investigations. Terns must ensure its data-sharing practices with global partners fall within these exemptions.

Second, the 2025 amendments to the FDAAA 801 Final Rule, effective in September 2025, significantly increase public transparency requirements and penalties for non-compliance.

• The rule imposes tighter deadlines for submitting clinical trial results to ClinicalTrials.gov.
• It mandates the public posting of informed consent documents.
• Non-compliance can result in daily civil monetary penalties and public notices of violation, which is a major reputational risk.

Terns' internal compliance and IT systems must be up-to-date to handle these faster reporting deadlines and new data fields. The company's privacy policy already states it generally receives de-identified patient data from Investigative Sites and CROs, but the increasing regulatory focus means their compliance framework needs constant auditing.

Terns Pharmaceuticals, Inc. (TERN) - PESTLE Analysis: Environmental factors

As a clinical-stage company, Terns' direct environmental impact from manufacturing is currently low.

You need to see Terns Pharmaceuticals, Inc. (TERN) for what it is: a clinical-stage biotech, not a major manufacturer. That means its direct environmental footprint from operations (Scope 1 and 2 emissions) is minimal compared to a company with commercial-scale production facilities. Still, this low impact is temporary. The company's focus is now heavily on advancing its Chronic Myeloid Leukemia (CML) candidate, TERN-701, toward a pivotal trial, which means a future pivot to commercial-scale manufacturing is the goal. When that happens, the environmental profile changes completely, bringing in significant risks related to energy consumption, water use, and air emissions that must be planned for now.

Here's the quick math on their current scale: Terns' Research and Development (R&D) expenses were $19.9 million for the quarter ended September 30, 2025. This R&D spend is primarily on clinical trials, contract research, and lab work, not large-scale, energy-intensive Active Pharmaceutical Ingredient (API) production. The real environmental risk is currently hidden in the supply chain (Scope 3), which is where 70% to 90% of the pharmaceutical industry's greenhouse gas (GHG) emissions originate.

Global regulatory bodies like the EMA are applying stricter guidelines on sustainability in manufacturing.

Even as a clinical-stage company, Terns cannot ignore global regulatory pressure, especially if it plans to commercialize TERN-701 in Europe. The European Medicines Agency (EMA) is embedding stricter sustainability requirements into its Good Manufacturing Practices (GMP) framework. For any future drug approval, Terns must conduct thorough environmental risk assessments (ERAs) for its pharmaceutical products. This means assessing the persistence, bioaccumulation, and toxicity of active ingredients in water and soil. This is a critical, up-front R&D cost that impacts the drug development timeline.

Also, the European Union's Corporate Sustainability Reporting Directive (CSRD), which took effect in 2025, mandates detailed sustainability reports for large companies operating in the EU. While Terns may not be immediately in the first wave of reporting, its future partners or acquirers will be, and they will demand this data. This isn't a future problem; it's a defintely a current due diligence requirement for any partnership. The EMA also recently updated guidance in August 2025 on transitioning to low global warming potential (GWP) propellants, a sign of the increasing granularity of environmental regulation.

US regulatory emphasis on ESG reporting may ease, but global investors still prioritize it.

Honestly, the US federal regulatory picture on Environmental, Social, and Governance (ESG) is fragmented right now; the Securities and Exchange Commission (SEC) climate disclosure rules are stalled due to legal challenges. But don't mistake federal inaction for a lack of risk. State-level regulations, particularly in California, are stepping in to fill the void. California's Senate Bills (SB) 253 and 261 mandate extensive greenhouse gas emissions and climate-related financial risk disclosures for large businesses operating in the state. Terns, being a California-based company, will face these requirements as its revenue grows past the $1 billion threshold defined in the proposed state bills.

The real driver is the capital market. Global investors are still prioritizing ESG. Major pharmaceutical companies are spending an estimated $5.2 billion yearly on environmental programs, a 300% increase from 2020. This is the market signal, not the SEC. Terns' ability to secure future funding and partnerships, especially for its metabolic assets, hinges on demonstrating a credible ESG strategy, even if the US federal government eases its reporting emphasis.

Waste management and disposal of chemical compounds from R&D remain a compliance requirement.

Even at the R&D scale, Terns is generating hazardous waste. The disposal of chemical compounds, solvents, and biological materials from its lab work is a non-negotiable compliance requirement under US Environmental Protection Agency (EPA) regulations. This is a cost center, not a variable expense.

The company must maintain strict protocols for waste segregation, labeling, and disposal, which adds to the General and Administrative (G&A) overhead, which was $7.8 million in Q3 2025. The industry is shifting toward Green Chemistry (GC) principles to proactively minimize waste and reduce the use of toxic solvents, which is the smart way to cut future compliance costs. Terns' R&D teams need to embed GC into their process design now to avoid costly retrofits later when TERN-701 moves to commercial production.

Here is a summary of the key environmental compliance pressures for Terns:

Environmental Factor	Regulatory Body/Standard	2025 Impact on Terns (TERN)
Future Manufacturing Sustainability	EMA GMP Guidelines (EU)	Future drug approval requires Environmental Risk Assessments (ERAs) for TERN-701 and other candidates, assessing persistence and toxicity of APIs.
Climate & GHG Disclosure	California SB 253/261 (US State)	Mandates Scope 1, 2, and 3 GHG emissions reporting for large companies (>$1B revenue); sets a de-facto US standard that Terns must prepare for.
R&D Waste Disposal	EPA Hazardous Waste Regulations (US Federal)	Mandatory compliance for disposal of chemical compounds and solvents from Q3 2025 R&D spend of $19.9 million.
Investor/Partner Due Diligence	EU CSRD & Global ESG Standards	Future partners for metabolic assets will demand ESG data aligned with standards like CSRD, even if Terns is not directly in scope yet.

Next step: Operations: Integrate Green Chemistry principles into all TERN-701 process development contracts by Q1 2026 to de-risk future commercial manufacturing.