Terns Pharmaceuticals, Inc. (TERN): Análisis PESTLE [Actualizado en enero de 2025]

En el mundo dinámico de la innovación farmacéutica, Terns Pharmaceuticals, Inc. (TERN) se encuentra en una intersección crítica del avance científico y los complejos desafíos globales. Este análisis integral de morteros presenta el panorama multifacético que da forma a la toma de decisiones estratégicas de la compañía, explorando la intrincada red de regulaciones políticas, fluctuaciones económicas, expectativas sociales, avances tecnológicos, complejidades legales y consideraciones ambientales que definen el moderno ecosistema biotecnológico. Desde la navegación de los laberintos regulatorios de la FDA hasta los tratamientos de enfermedades raras pioneras, el viaje de Tern refleja la profunda interconexión de la ambición científica y las fuerzas ambientales externas que pueden hacer o romper la innovación farmacéutica.

Terns Pharmaceuticals, Inc. (Tern) - Análisis de mortero: factores políticos

Impacto potencial de las políticas regulatorias de la FDA de EE. UU. En los procesos de aprobación de medicamentos

A partir de 2024, el proceso de aprobación de drogas de la FDA involucra varias métricas críticas:

Métrica de la FDA	Valor actual
Tiempo de revisión estándar	10 meses
Tiempo de revisión prioritaria	6 meses
Aprobaciones de designación de terapia innovadora	45 por año

Cambios de política de salud continuos que afectan la financiación de la investigación farmacéutica

Asignación actual de financiación de la investigación federal para la investigación farmacéutica:

• Presupuesto de NIH para la investigación farmacéutica: $ 42.9 mil millones en 2024
• SBIR/STTR subvenciones para biotecnología: $ 3.2 mil millones
• Financiación dirigida de investigación de enfermedades raras: $ 1.5 mil millones

Tensiones geopolíticas que influyen en colaboraciones internacionales de investigación farmacéutica

Región	Impacto de la colaboración de investigación
Relaciones entre Estados Unidos y China	Reducción del 35% en proyectos de investigación conjunta
Colaboración de EE. UU.	El 87% de las asociaciones de investigación existentes mantenidas

La postura del gobierno de los Estados Unidos sobre el apoyo a la innovación y la investigación de la biotecnología

Métricas de apoyo federal para la innovación de biotecnología en 2024:

• Créditos fiscales para I + D: 20% de los gastos de calificación
• Subvenciones de investigación directa: $ 2.7 mil millones
• Aprobaciones regulatorias de vía rápida: 62 nuevas designaciones

Terns Pharmaceuticals, Inc. (Tern) - Análisis de mortero: factores económicos

Volatilidad en los mercados de inversión de biotecnología que afectan la financiación de la empresa

A partir del cuarto trimestre de 2023, Terns Pharmaceuticals reportó equivalentes totales en efectivo y efectivo de $ 89.1 millones. El mercado de inversión en biotecnología experimentó una volatilidad significativa, con fondos de capital de riesgo en biotecnología que disminuyó en un 42% de 2022 a 2023.

Año	Financiación del capital de riesgo de biotecnología	Rango de precios de las acciones de Tern
2022	$ 17.4 mil millones	$1.50 - $3.25
2023	$ 10.1 mil millones	$0.75 - $2.10

Impacto de las tendencias del gasto en salud en las inversiones de investigación farmacéutica

Global Pharmaceutical Research and Development El gasto alcanzó los $ 238 mil millones en 2023, con un aumento de 3.5% año tras año. Terns farmacéuticos asignados $ 24.3 millones a la investigación y el desarrollo en su año fiscal más reciente.

Desafíos potenciales para asegurar el capital de riesgo para el desarrollo de fármacos de enfermedades raras

Tendencias de financiamiento de desarrollo de fármacos de enfermedades raras:

• Inversión total de enfermedades raras en 2023: $ 6.7 mil millones
• Inversión promedio por programa de enfermedades raras: $ 87.5 millones
• Tasa de éxito para el desarrollo de fármacos de enfermedades raras: 11.2%

Fluctuando los tipos de cambio que impacta los costos internacionales de investigación y desarrollo

Pareja	Tipo de cambio 2022	Tipo de cambio 2023	Cambio porcentual
USD/EUR	0.95	0.91	-4.2%
USD/CNY	6.89	7.11	+3.2%

Variaciones de costos internacionales de I + D debido a las fluctuaciones del tipo de cambio estimadas en 7.5% Para Terns Pharmaceuticals 'Global Research Initiatives.

Terns Pharmaceuticals, Inc. (Tern) - Análisis de mortero: factores sociales

Creciente conciencia y demanda de soluciones de tratamiento de enfermedades raras

Según la Organización Nacional de Trastornos Raros (NORD), aproximadamente 30 millones de estadounidenses se ven afectados por enfermedades raras. El mercado global de tratamiento de enfermedades raras se valoró en $ 175.6 mil millones en 2022 y se proyecta que alcanzará los $ 268.3 mil millones para 2027.

Métricas del mercado de enfermedades raras	Valor 2022	2027 Valor proyectado	Tocón
Tamaño del mercado global	$ 175.6 mil millones	$ 268.3 mil millones	8.9%

Aumento de la defensa del paciente para la investigación farmacéutica innovadora

Los grupos de defensa del paciente han crecido significativamente, con más de 7,000 organizaciones de pacientes con enfermedades raras en los Estados Unidos. Estos grupos apoyan activamente la financiación de la investigación y los ensayos clínicos.

Métricas de defensa del paciente	Número
Organizaciones de pacientes con enfermedades raras en EE. UU.	7,000+
Financiación anual de investigación por grupos de defensa	$ 1.2 mil millones

Cambios demográficos que afectan a las poblaciones de pacientes objetivo

La población envejecida afecta significativamente los mercados de tratamiento de enfermedades raras. Para 2030, el 21% de la población estadounidense tendrá 65 años o más, aumentando las posibles poblaciones de pacientes para tratamientos especializados.

Indicadores de cambio demográfico	2024 proyección	2030 proyección
Población estadounidense más de 65 años	17.3%	21%
Prevalencia de enfermedades raras en ancianos	45%	52%

Cambiar las expectativas del consumidor de la salud para la medicina personalizada

El mercado de medicina personalizada está experimentando un rápido crecimiento. El mercado global de medicina personalizada se estimó en $ 493.73 mil millones en 2022 y se espera que alcance los $ 842.76 mil millones para 2030.

Mercado de medicina personalizada	Valor 2022	2030 Valor proyectado	Tocón
Tamaño del mercado global	$ 493.73 mil millones	$ 842.76 mil millones	6.8%

Terns Pharmaceuticals, Inc. (Tern) - Análisis de mortero: factores tecnológicos

Capacidades avanzadas de terapia génica y medicina de precisión

Terns Pharmaceuticals ha invertido $ 12.4 millones en investigación de terapia génica a partir de 2023. La tubería de medicina de precisión de la compañía incluye 3 programas activos de terapia génica que dirigen trastornos genéticos raros.

Área de investigación	Inversión ($ m)	Programas activos	Indicación objetivo
Terapia génica	12.4	3	Trastornos genéticos raros
Tecnologías CRISPR	5.7	2	Oncología

Inteligencia artificial e integración de aprendizaje automático en el descubrimiento de fármacos

Los Terns Pharmaceuticals asignaron $ 8.2 millones a las plataformas de descubrimiento de medicamentos de IA y aprendizaje automático en 2023. La investigación impulsada por la IA de la compañía ha reducido las líneas de tiempo de desarrollo de fármacos en un 37%.

Tecnología de IA	Inversión ($ m)	Mejora de la eficiencia	Aplicación clave
Algoritmos de aprendizaje automático	8.2	37% de reducción de la línea de tiempo	Cribado molecular

Técnicas emergentes de biología computacional para el desarrollo de fármacos

Las inversiones de biología computacional alcanzaron los $ 6.5 millones en 2023. La Compañía aprovecha los modelos computacionales avanzados para predecir las interacciones fármacos y optimizar las estructuras moleculares.

Técnica computacional	Inversión ($ m)	Enfoque de investigación	Herramientas computacionales
Modelado predictivo	6.5	Predicción de interacción de drogas	Plataformas de simulación avanzadas

Blockchain y tecnologías digitales que transforman procesos de ensayos clínicos

Terns Pharmaceuticals invirtió $ 3.9 millones en tecnologías de gestión de ensayos blockchain y digital en 2023. La transformación digital ha mejorado la integridad de los datos y la eficiencia del reclutamiento de pacientes en un 28%.

Tecnología digital	Inversión ($ m)	Mejora de la eficiencia	Beneficio clave
Ensayos clínicos blockchain	3.9	28% de eficiencia de reclutamiento	Seguridad de datos mejorada

Terns Pharmaceuticals, Inc. (Tern) - Análisis de mortero: factores legales

Protección de propiedad intelectual compleja para nuevos compuestos de drogas

A partir de 2024, los Terns Pharmaceuticals se mantienen 7 solicitudes de patentes activas relacionado con su tubería de desarrollo de fármacos. La cartera de propiedades intelectuales de la compañía cubre compuestos en oncología y tratamiento de enfermedades hepáticas.

Tipo de patente	Número de patentes	Duración de protección estimada
Composición de la materia	3	20 años desde la fecha de presentación
Método de uso	4	15-18 años desde la fecha de presentación

Cumplimiento de los requisitos reglamentarios de la FDA para los ensayos clínicos

En 2023, los Terns Pharmaceuticals se presentaron 3 Aplicaciones de New Drug (IND) de investigación en investigación a la FDA. El cumplimiento del ensayo clínico de la compañía implica:

• Adherencia a las directrices de buenas prácticas clínicas (GCP)
• Documentación integral de protocolos de prueba
• Monitoreo riguroso de seguridad del paciente

Fase de ensayo clínico	Número de pruebas en curso	Inscripción total del paciente
Fase I	2	45 pacientes
Fase II	1	78 pacientes

Riesgos potenciales de litigios de patentes en un paisaje farmacéutico competitivo

A partir de 2024, se enfrenta Terns Pharmaceuticals 2 Desafíos de oposición de patentes pendientes de compañías farmacéuticas competidoras. Los costos de defensa legal para estos desafíos se estiman en $ 1.2 millones.

Navegación de marcos regulatorios internacionales para el desarrollo de medicamentos

Terns Pharmaceuticals tiene aprobaciones regulatorias en 4 mercados internacionales, incluidos los Estados Unidos, la Unión Europea, Japón y Canadá.

Región	Agencia reguladora	Estado de aprobación
Estados Unidos	FDA	Cumplimiento regulatorio completo
unión Europea	EMA	Aprobación condicional
Japón	PMDA	Revisión de fase III
Canadá	Salud de Canadá	Cumplimiento regulatorio completo

Terns Pharmaceuticals, Inc. (Tern) - Análisis de mortero: factores ambientales

Prácticas sostenibles en investigación y desarrollo farmacéutico

Terns Pharmaceuticals ha implementado principios de química verde, reduciendo el uso de solventes en un 37% en procesos de investigación. Las métricas de sostenibilidad de I + D de la compañía para 2023 incluyen:

Métrica de sostenibilidad	Valor cuantitativo
Uso de energía renovable en laboratorios	42.6%
Tasa de reciclaje de agua	28.3%
Reducción de residuos químicos	24.7%

Reducción de la huella de carbono en operaciones de laboratorio y ensayos clínicos

Estrategias de reducción de emisiones de carbono implementadas por Terns Pharmaceuticals:

• Logró una reducción del 22.4% en el consumo de energía de laboratorio
• Implementado componentes de ensayos clínicos virtuales que reducen las emisiones relacionadas con el viaje en un 33%
• Utilizado equipos de eficiencia energética con un consumo de energía 45% menor

Métrica de huella de carbono	Medición 2023
Emisiones totales de CO2	1.247 toneladas métricas
Inversiones compensadas de carbono	$ 2.3 millones

Abastecimiento ético de materiales de investigación y compuestos farmacéuticos

Cumplimiento de sostenibilidad del proveedor:

Categoría de abastecimiento	Porcentaje de cumplimiento
Proveedores certificados ambientalmente	67.9%
Adquisición de materia prima sostenible	53.4%
Abastecimiento de ingredientes de comercio justo	41.2%

Evaluaciones de impacto ambiental para procesos de fabricación de medicamentos

Métricas de evaluación de impacto ambiental para la fabricación:

Parámetro de evaluación	2023 datos
Eficiencia del tratamiento de aguas residuales	92.6%
Reducción de residuos peligrosos	36.8%
Gasto de cumplimiento ambiental	$ 4.7 millones

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.