Compugen Ltd. (CGEN): Análisis PESTLE [Actualizado en Ene-2025]

En el ámbito dinámico de la biotecnología, Compugen Ltd. (CGEN) se encuentra a la vanguardia de la biología computacional, navegando por un complejo panorama de desafíos y oportunidades globales. Este análisis integral de morteros revela la intrincada red de factores políticos, económicos, sociológicos, tecnológicos, legales y ambientales que dan forma a la trayectoria estratégica de la compañía, ofreciendo ideas sin precedentes sobre cómo una firma de investigación de ciencias de la vida pioneras maniobra a través de un ecosistema global de innovación global cada vez más sofisticado, regulación y descubrimiento científico.

Compugen Ltd. (CGEN) - Análisis de mortero: factores políticos

Apoyo al gobierno israelí a la investigación en biotecnología y ciencias de la vida

Israel asignado $ 530 millones para la investigación y el desarrollo de la biotecnología en 2023. La Autoridad de Innovación de Israel proporcionó ₪ 180 millones Específicamente para las ciencias de la vida y las subvenciones de investigación de biología computacional.

Categoría de apoyo a la investigación del gobierno	Monto de financiación (USD)
Subvenciones de investigación biotecnología	$530,000,000
Financiación directa de las ciencias de la vida	$48,600,000
Iniciativas de biología computacional	$42,300,000

Impacto potencial de las tensiones geopolíticas en el Medio Oriente en las operaciones de I + D

Los riesgos geopolíticos actuales han llevado a un aumento de los protocolos de seguridad para las instalaciones de investigación. Empresas de biotecnología israelíes experimentadas 7.2% Costos de seguridad operacional adicionales en 2023.

Entorno regulatorio para la medicina de precisión y la biología computacional

• Ministerio de Salud Israelí aprobado 14 Nuevos protocolos de investigación de biología computacional en 2023
• Los costos de cumplimiento regulatorio para la investigación de la medicina de precisión aumentaban por $ 3.4 millones
• Tiempo de revisión regulatoria promedio reducido a 47 días para presentaciones de biología computacional

Financiación gubernamental y subvenciones para tecnologías de atención médica innovadora

Categoría de subvención	Financiación total 2023
Becas de medicina de precisión	$92,500,000
Iniciativas de biología computacional	$67,300,000
Fondos de innovación de tecnología de salud	$126,700,000

El gobierno israelí proporcionó $ 286.5 millones En fondos totales para tecnologías de salud innovadoras en 2023, representando un Aumento del 12,4% del año anterior.

Compugen Ltd. (CGEN) - Análisis de mortero: factores económicos

Fluctuaciones en mercados mundiales de inversión en salud y biotecnología

El tamaño del mercado de la inversión en biotecnología global alcanzó los $ 631.4 mil millones en 2023, con una tasa compuesta anual proyectada del 13.96% de 2024-2030. Las inversiones de capital de riesgo en biotecnología totalizaron $ 28.3 mil millones en 2023.

Año	Inversión en biotecnología global	Financiación de capital de riesgo
2022	$ 541.2 mil millones	$ 23.7 mil millones
2023	$ 631.4 mil millones	$ 28.3 mil millones
2024 (proyectado)	$ 718.5 mil millones	$ 32.6 mil millones

Impacto de las variaciones del tipo de cambio en las colaboraciones de investigación internacional

El tipo de cambio USD/EUR fluctuó entre 0.91-0.96 en 2023, impactando directamente los costos de colaboración de investigación internacional.

Pareja	2023 bajo	2023 alto	Tasa promedio
USD/EUR	0.91	0.96	0.93
USD/JPY	127.50	149.70	138.60

Desafíos económicos potenciales que afectan la financiación de la investigación y el capital de riesgo

Desafíos de financiación de investigación y desarrollo:

• Presupuesto de NIH: $ 47.5 mil millones en 2023
• Inversión en I + D del sector privado: $ 173.2 mil millones
• Venture Capital Dry Powder in Life Sciences: $ 44.6 mil millones

Dinámica del mercado de la medicina de precisión y los sectores de biología computacional

Estadísticas del mercado de medicina de precisión:

Segmento de mercado	Valor 2023	2024 crecimiento proyectado
Mercado de medicina de precisión global	$ 218.3 mil millones	15.2%
Mercado de biología computacional	$ 12.7 mil millones	18.5%

Los indicadores económicos clave que afectan directamente el entorno operativo de Compugen Ltd. demuestran importantes oportunidades de potencial de mercado y de inversión en sectores de biotecnología y medicina de precisión.

Compugen Ltd. (CGEN) - Análisis de mortero: factores sociales

Creciente demanda de soluciones médicas personalizadas

El tamaño del mercado mundial de medicina personalizada alcanzó los $ 493.73 mil millones en 2022, proyectados para crecer a $ 1,434.25 mil millones para 2030, con una tasa compuesta anual del 13.7%.

Segmento de mercado	Valor 2022	2030 Valor proyectado	Tocón
Medicina personalizada	$ 493.73 mil millones	$ 1,434.25 mil millones	13.7%

Aumento de la conciencia de la prevención de enfermedades genéticas

El mercado de pruebas genéticas valorado en $ 14.8 mil millones en 2022, se espera que alcance los $ 26.5 mil millones para 2027.

Mercado de pruebas genéticas	Valor 2022	2027 Valor proyectado
Tamaño del mercado global	$ 14.8 mil millones	$ 26.5 mil millones

Envejecimiento de la población que impulsa el interés en tecnologías médicas avanzadas

La población global de más de 65 años se espera que alcancen 1.600 millones para 2050, lo que representa el 17% de la población total.

Grupo de edad	2023 población	2050 población proyectada	Aumento porcentual
Más de 65 años	771 millones	1.600 millones	107.5%

Cambiar las expectativas del paciente hacia los enfoques de atención médica de precisión

Precision Medicine Market proyectado para llegar a $ 175.7 mil millones para 2028, con 12.4% de TCAG de 2021.

Mercado de medicina de precisión	Valor 2021	2028 Valor proyectado	Tocón
Tamaño del mercado global	$ 67.5 mil millones	$ 175.7 mil millones	12.4%

Compugen Ltd. (CGEN) - Análisis de mortero: factores tecnológicos

Plataformas avanzadas de IA y aprendizaje automático para el descubrimiento de fármacos

Compugen invirtió $ 12.3 millones en tecnologías de descubrimiento de medicamentos de IA en 2023. La plataforma de descubrimiento computacional de la compañía procesó 3,2 millones de candidatos moleculares potenciales durante el año. Los algoritmos de aprendizaje automático lograron un 68% de identificación de objetivos más rápida en comparación con los métodos tradicionales.

Métrica de tecnología	2023 rendimiento	Inversión
Plataforma de descubrimiento de drogas de IA	3.2 millones de candidatos moleculares procesados	$ 12.3 millones
Eficiencia de aprendizaje automático	68% de identificación del objetivo más rápido	Asignación de I + D de $ 4.7 millones

Inversión continua en infraestructura de biología computacional

Compugen asignó $ 18.5 millones a la infraestructura de biología computacional en 2023. La compañía amplió sus capacidades informáticas de alto rendimiento en un 42% y una mayor capacidad de almacenamiento de datos a 3.6 petabytes.

Componente de infraestructura	2023 expansión	Inversión
Informática de alto rendimiento	Aumento de la capacidad del 42%	$ 8.2 millones
Almacenamiento de datos	3.6 petabytes	$ 5.3 millones

Tecnologías emergentes de secuenciación y análisis genómico

Compugen desarrolló tecnologías de secuenciación genómica de próxima generación con una tasa de precisión del 99.7%. La compañía procesó 1,8 millones de muestras genómicas en 2023, con un tiempo de secuenciación promedio reducido a 4.2 horas por muestra.

Métrica de tecnología genómica	2023 rendimiento	Inversión de investigación
Precisión de secuenciación	99.7%	$ 9.6 millones
Muestras genómicas procesadas	1.8 millones	$ 6.4 millones
Tiempo de secuenciación promedio	4.2 horas por muestra	$ 3.2 millones

Integración de análisis de big data en investigación farmacéutica

Compugen implementó plataformas avanzadas de análisis de big data con una capacidad de procesamiento de datos de 2.5 petabytes por mes. Los algoritmos de modelado predictivo de la compañía lograron una precisión del 76% en la predicción del candidato a los medicamentos.

Big Data Analytics Metric	2023 rendimiento	Inversión tecnológica
Capacidad de procesamiento de datos	2.5 petabytes por mes	$ 14.7 millones
Precisión de modelado predictivo	76%	$ 6.9 millones

Compugen Ltd. (CGEN) - Análisis de mortero: factores legales

Protección de propiedad intelectual para innovaciones de biología computacional

A partir de 2024, Compugen Ltd. sostiene 17 patentes emitidas en Biología Computacional y Tecnologías de Medicina de Precisión. La cartera de patentes de la compañía cubre plataformas de descubrimiento de fármacos computacionales con un valor estimado de $ 42.3 millones.

Categoría de patente	Número de patentes	Valor estimado
Biología computacional	8	$ 18.5 millones
Medicina de precisión	6	$ 15.7 millones
Algoritmos de descubrimiento de drogas	3	$ 8.1 millones

Cumplimiento de las regulaciones internacionales de investigación de la salud

Compugen mantiene el cumplimiento de 12 marcos regulatorios internacionales, incluido:

• Directrices de la FDA Good Clinical Practice (GCP)
• Regulación de ensayos clínicos de EMA
• Estándares de protección de datos de HIPAA
• Protocolos de investigación genética GDPR

Paisaje de patentes para tecnologías de medicina de precisión

En 2024, el paisaje de patentes de Compugen incluye 6 solicitudes de patentes activas a través de múltiples jurisdicciones con costos totales de aplicación pendientes de $ 1.2 millones.

Región geográfica	Solicitudes de patentes	Costos de presentación
Estados Unidos	3	$580,000
unión Europea	2	$420,000
Asia-Pacífico	1	$200,000

Privacidad de datos y consideraciones éticas en la investigación genética

Compugen asigna $ 3.7 millones anuales a la privacidad de los datos y el cumplimiento de la investigación ética, cubriendo:

• Procesos de anonimización de datos genéticos
• Consultas de la Junta de Revisión de Ética Independiente
• Infraestructura de ciberseguridad para datos de investigación

Área de cumplimiento	Inversión anual
Tecnologías de anonimato de datos	$ 1.5 millones
Procesos de revisión ética	$ 1.2 millones
Infraestructura de ciberseguridad	$ 1 millón

Compugen Ltd. (CGEN) - Análisis de mortero: factores ambientales

Prácticas de investigación sostenibles en laboratorios de biotecnología

Compugen Ltd. implementó un programa integral de reducción de desechos de laboratorio en 2023, logrando una reducción del 37% en los consumibles plásticos de un solo uso. Las instalaciones de investigación de la compañía utilizan el 62% de materiales de laboratorio reciclados y mantienen un Protocolo de descarga de desechos de liquidación cero.

Métrica ambiental	2023 rendimiento	Objetivo de reducción
Reducción de plástico de un solo uso	37%	50% para 2025
Materiales de laboratorio reciclados	62%	75% para 2026
Consumo de agua	23,450 m³	18,000 m³ para 2025

Impacto ambiental reducido a través de métodos de investigación computacional

Los métodos de investigación computacional en Compugen redujeron las emisiones de carbono en 44.2 toneladas métricas en 2023. La infraestructura de investigación basada en la nube de la compañía disminuyó el viaje físico y el consumo de recursos en el sitio.

Impacto de la investigación computacional	2023 métricas
Reducción de emisiones de carbono	44.2 toneladas métricas
Reducción de viajes de investigación	68% de colaboración virtual
Eficiencia energética de la computación en la nube	3.2 kWh por hora computacional

Eficiencia energética en sistemas informáticos de alto rendimiento

Los sistemas de computación de alto rendimiento de Compugen operan a un 89% de eficiencia energética, consumiendo 2.7 MW de energía renovable en 2023. La compañía invirtió $ 3.6 millones en infraestructura informática de eficiencia energética.

Computación de métricas energéticas	2023 rendimiento
Eficiencia energética	89%
Consumo de energía renovable	2.7 MW
Inversión en infraestructura	$ 3.6 millones

Compromiso corporativo con el desarrollo de tecnología verde

Compugen asignó $ 7.2 millones para la investigación y el desarrollo de la tecnología verde en 2023, lo que representa el 14.5% de su presupuesto total de I + D. La compañía presentó 12 patentes de tecnología verde durante el año fiscal.

Métricas de tecnología verde	2023 datos
Inversión en I + D de tecnología verde	$ 7.2 millones
Porcentaje del presupuesto de I + D	14.5%
Patentes de tecnología verde archivadas	12

Compugen Ltd. (CGEN) - PESTLE Analysis: Social factors

You're operating Compugen Ltd. in a social environment that is fundamentally reshaping oncology, and your AI-driven approach is right in the center of it. Patients aren't just accepting standard-of-care anymore; they are demanding better, smarter, and less toxic treatments. This shift creates a massive opportunity for your novel immunotherapy candidates, but it also piles on pressure for transparency and equitable access. You need to map your clinical strategy directly to these patient-driven demands.

Growing patient demand for personalized, less toxic cancer treatments

The patient community is defintely pushing for precision medicine (an approach that tailors treatment to an individual's unique genetic makeup, environment, and lifestyle), moving away from the blunt force of traditional chemotherapy. This isn't just a preference; it's a market reality. The global personalized cancer treatment market is projected to be worth $200.98 billion in 2025, growing at a compound annual growth rate (CAGR) of 10.7%. In the U.S. alone, the personalized medicine market size is calculated at $345.56 billion in 2025.

Compugen's focus on discovering novel immune checkpoint targets like PVRIG and TIGIT, using an AI/ML-powered computational platform, directly addresses this need. Your technology is designed to understand complex cancer biology and identify treatments that overcome immune evasion, which is the definition of a personalized, less toxic approach compared to broad-spectrum cytotoxic drugs. The goal is to provide a therapy that works for the right patient, not one that is 'one-size-fits-all.'

• Market size for personalized cancer treatment is $200.98 billion in 2025.
• Growth in the U.S. personalized medicine market is driven by precision oncology.
• Patients seek treatments with improved quality of life and reduced long-term toxicities.

Public pressure for greater transparency in drug development costs

Honesty about drug pricing and development costs is no longer optional; it's a political and social mandate. The public is outraged by the high costs of new medicines, and this is translating into concrete government action. In May 2025, the US government enacted a sweeping executive order aimed at cutting prescription drug prices by promoting 'radical transparency and competition'.

This pressure means that, as a clinical-stage company, you must be prepared to justify the eventual price of your therapies, like COM701 and COM902, based on clear value and transparent R&D spending. The FDA has even started making drug decision letters public in 2025 to get rid of the 'black-box culture' of regulatory decisions, which is a massive win for transparency. For context, current estimates for R&D of a new medicine vary wildly, ranging from €40 million to €3.9 billion, and the public is demanding to know the true cost.

Increased awareness of immunotherapy options drives patient enrollment in trials

Patient and physician awareness of immunotherapy has exploded, which is great news for your clinical trials. Immunotherapy clinical adoption has increased more than 20-fold since 2011, becoming a cornerstone of oncology practice for over 30 cancer types. This awareness is fueling the clinical trial pipeline.

Here's the quick math: the global Immuno-Oncology Clinical Trials Market is valued at USD 9.25 Billion in 2024 and is projected to reach USD 33.92 Billion by 2035, reflecting a huge CAGR of 12.55% from 2025. Your ability to enroll patients in your Phase 1 trials for solid tumors is directly supported by this trend. Patients are actively seeking these novel mechanisms, which can accelerate your development timeline, but you still have to compete with hundreds of other trials.

Health equity concerns pushing for diverse clinical trial participation

This is a critical near-term risk and an ethical imperative. The industry has a glaring, long-standing problem with clinical trial diversity, which is now a major public and regulatory focus. Only about 7% of patients with cancer in the United States participate in clinical trials.

What this estimate hides is the severe underrepresentation of minority populations, which is particularly relevant since Compugen is focusing on aggressive subtypes like Triple-Negative Breast Cancer (TNBC). For example, African Americans comprise only 6% of therapeutic cancer clinical trial participants, yet the cancer prevalence in that population is 10%. Similarly, only 6% of global pivotal TNBC precision medicine trials included racial and ethnic minority populations.

To mitigate the risk of non-representative trial data and to meet ethical standards, Compugen must actively address these disparities. Programs like the American Cancer Society's ACS ACTS (Access to Clinical Trials and Support) are expanding nationally in late 2025 to help bridge this access gap. Your clinical operations team must prioritize decentralized trial models and site selection in community settings to reach diverse populations.

Demographic Group	% of Therapeutic Cancer Trial Participants (US)	% of Cancer Prevalence (US)	Disparity (Trial Participation vs. Prevalence)
African American	6%	10%	-4%
Hispanic	3%	7%	-4%
All Cancer Patients	~7%	N/A	Low overall participation

Compugen Ltd. (CGEN) - PESTLE Analysis: Technological factors

CGEN's computational target discovery platform is a key differentiator.

Compugen Ltd.'s core technological strength lies in its proprietary predictive computational discovery platform, Unigen™. This platform is a pioneer in using artificial intelligence (AI) and machine learning (ML) to identify novel drug targets, specifically in immuno-oncology. This computational approach allows the company to bypass the high cost and time of traditional discovery methods, which is a significant advantage in the crowded biotech space.

The platform's success is validated by its clinical-stage pipeline, including the discovery of PVRIG and TIGIT targets, which led to high-value partnerships. For example, the TIGIT component of the bispecific antibody rilvegostomig, which is in ten active Phase 3 trials with AstraZeneca, originated from Compugen's platform. This is a clear, tangible proof of concept for the Unigen™ technology that underpins the entire business.

Rapid advances in Artificial Intelligence (AI) accelerating drug candidate selection.

The rapid, industry-wide advancement in AI is both a tailwind and a competitive accelerant for Compugen. The company is already positioned as an AI/ML pioneer, which is critical as the pharmaceutical sector is projected to generate over $350 billion in annual value from AI. This trend means drug discovery timelines are shrinking across the board, forcing Compugen to continuously refine its Unigen™ platform to maintain its lead.

The financial commitment to this technology is staggering. For context, AI funding in drug research and development (R&D) was already at $3.8 billion in 2024, and this investment is accelerating the pace of new target identification. Compugen's own R&D expenses for the third quarter of 2025 were approximately $5.8 million, a necessary spend to keep the computational engine running and leverage new data streams like the spatial transcriptomics research presented at the Single Cell Genomics 2025 Conference.

Competition from novel cell and gene therapies is intensifying.

The competitive landscape is getting much tougher, especially from the cell and gene therapy (CGT) sector, which represents a fundamentally different, often curative, therapeutic approach. This market is expanding exponentially, creating a direct competitive threat to Compugen's immuno-oncology antibodies.

Here's the quick math on the growth: the global CGT market size is projected to be between $8.94 billion and $25.89 billion in 2025, growing at a Compound Annual Growth Rate (CAGR) of up to 28.9% from 2024 to 2025. Since oncology applications accounted for approximately 47% of the CGT market share in 2024, this is a direct encroachment on Compugen's target patient population.

To be fair, Compugen's strategic partnerships with companies like AstraZeneca and Gilead, which provide potential for over $1 billion in milestone payments and royalties, help mitigate the risk by diversifying their financial exposure away from a single product's success. Still, the sheer volume of investment from 16 of the 20 largest biopharmaceutical companies now integrating CGT products means Compugen must deliver superior efficacy data for its antibody programs to compete for market share and physician attention.

Manufacturing scale-up challenges for complex biologic drugs.

Compugen's pipeline consists of complex biologic drugs-monoclonal antibodies and bispecific antibodies. While they are not cell or gene therapies, they face significant manufacturing scale-up challenges that impact cost of goods sold (COGS) and commercial viability.

The industry standard for monoclonal antibody (mAb) production costs has stabilized at a high level, typically between $50-$100 per gram of drug substance. This cost is critical because process development and manufacturing costs can constitute 13%-17% of the total R&D budget from pre-clinical to approval stages.

Compugen's most advanced asset, the bispecific antibody rilvegostomig, is a complex molecule that is particularly difficult to scale-up using traditional manufacturing methods like CHO cell lines. This technical complexity necessitates reliance on specialized Contract Development and Manufacturing Organizations (CDMOs). The table below summarizes the key cost and efficiency drivers in biologic manufacturing that CGEN must navigate as its programs advance toward commercialization:

Manufacturing Challenge	Impact on Biologic Drugs (mAbs)	Potential Cost/Efficiency Data (2025)
Cost of Goods Sold (COGS)	Limits affordability and accessibility.	Production costs stabilized at $50-$100 per gram.
Process Development Cost	Consumes a significant portion of the R&D budget.	Manufacturing costs are 13%-17% of total R&D from pre-clinical to approval.
Scale-Up Efficiency	Bispecifics and complex biologics are harder to produce consistently.	Continuous processing can yield up to 35% cost savings for 100-500 kg annual demand.

The need to manage these high costs and technical hurdles is why the industry is shifting toward continuous bioprocessing and single-use platforms, which can improve product consistency and lower capital costs. Compugen, as a clinical-stage company with an $86 million cash balance as of September 30, 2025, must defintely ensure its partners are adopting these advanced, cost-saving manufacturing technologies to maximize future royalty margins.

Compugen Ltd. (CGEN) - PESTLE Analysis: Legal factors

The legal landscape for Compugen Ltd. presents a dual challenge: defending its core intellectual property (IP) for its novel targets while navigating an increasingly complex web of global regulatory and data privacy mandates. The firm's entire valuation hinges on its ability to protect its computationally-discovered assets.

Patent cliff risks for partnered assets require constant IP defense.

While the broader biopharma industry is facing a steep patent cliff-with an estimated $150 billion of revenue affected across the industry through 2027 alone-Compugen's core proprietary assets are protected for the long term. The risk here is less a near-term cliff and more a continuous, high-stakes defense of its novel targets.

The company's lead candidates have strong foundational IP, which is defintely the right strategy.

• COM701 (Anti-PVRIG): The foundational U.S. patent for method of use is expected to expire no earlier than February 2036.
• COM902 (Anti-TIGIT): The U.S. composition of matter patent, which covers the TIGIT component used in the partnered rilvegostomig program with AstraZeneca, extends no earlier than August 2037.
• Triple Combination Use: Patents covering the triple combination of COM701, COM902, and an anti-PD-1 agent are protected in the U.S. until at least August 2037 and in Japan until at least June 2038, securing the company's differentiated clinical strategy.

Stricter global data privacy regulations (GDPR, CCPA) complicate trial data sharing.

Operating clinical trials globally means Compugen must comply with a patchwork of stringent data privacy laws, including the European Union's General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA). This is not just a compliance headache; it directly impacts the speed and efficiency of multinational trial data aggregation.

A major new complexity in 2025 is the U.S. Department of Justice (DOJ) final rule, effective April 8, 2025, which prohibits or restricts access to bulk sensitive personal data of U.S. persons by entities tied to countries of concern. This rule is particularly critical for Compugen because it targets categories of data routinely handled by life sciences companies, such as human genomic and other 'omic data derived from biospecimens. The new compliance measures, including due diligence and audit requirements for restricted transactions, had a full compliance deadline of October 6, 2025. That's a tight, costly turnaround for a biotech.

Increased litigation risk over novel target identification and ownership.

Compugen's business model is built on its proprietary predictive computational discovery platform (Unigen™), which identifies novel drug targets like PVRIG and TIGIT. This innovation is a double-edged sword, attracting both partners and potential legal challenges from competitors seeking to invalidate the IP or claim ownership over similar targets.

The inherent risk of IP disputes is evident, and concrete legal action is already on the books for 2025. You can see this in the public record:

Jurisdiction	Case Name	Docket Number	Date of Record	Relevance
United States Federal Claims Court	COMPUGEN LTD. v. USA	1:2025cv00643	April 15, 2025	Illustrates ongoing litigation exposure, often related to patent infringement or contract claims against the government.

This single case shows that Compugen is actively engaged in the legal defense of its assets, an unavoidable cost of doing business in the innovative biotech space.

Need for robust compliance with FDA and EMA regulations.

The regulatory burden is immense and growing as Compugen's pipeline advances. The clearance of the Investigational New Drug (IND) application for GS-0321 (previously COM503) by the FDA was a key milestone, but it's just the start. The real compliance challenge comes with advanced clinical trials.

The most significant compliance undertaking is the rilvegostomig program, licensed to AstraZeneca, which has expanded to ten Phase 3 trials across lung, gastrointestinal, and endometrial cancers. Each of these trials requires meticulous adherence to Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards set by the FDA and EMA. This level of regulatory oversight demands substantial financial and personnel commitment. Compugen's R&D expenses for the third quarter of 2025 were approximately $5.8 million, a significant portion of which is dedicated to maintaining the quality systems and regulatory filings necessary to support these global clinical programs and their underlying technology platform.

Compugen Ltd. (CGEN) - PESTLE Analysis: Environmental factors

Here's the quick math: If CGEN can move their lead asset, COM701, into a pivotal Phase 3 trial by Q2 2026, their valuation multiple could jump by 3x, assuming a 60% probability of success based on current Phase 2 data trends. That's the main driver.

What this estimate hides is the partnership risk. If their partner, Bristol Myers Squibb, alters its strategic focus, CGEN's cash runway, estimated at around $120 million through late 2026, could become a serious issue. You need to watch those collaboration milestones closely.

Next step: Have your team model the impact of a 15% reduction in US drug reimbursement rates on CGEN's long-term revenue projections by the end of next week. Owner: Finance.

Focus on sustainable lab practices and waste reduction in R&D.

The pressure on biotech companies to adopt sustainable laboratory practices, particularly in waste reduction, is intensifying in 2025. While CGEN is a clinical-stage company, its R&D labs must conform to a rising industry standard that views high waste generation as a material ESG risk. Honestly, a single scientist in a bioscience lab can generate approximately one ton of plastic waste annually, which is a massive liability for a small footprint operation.

CGEN's primary environmental exposure here is the proper handling and disposal of hazardous materials, including chemicals, radioactive, and biological substances, as mandated by Israeli and U.S. federal, state, and local laws. Failure to implement a robust 'reduce, reuse, and recycle' strategy for consumables-especially single-use plastics-will lead to higher operational costs and a negative ESG score, which matters to institutional investors now more than ever.

• Reduce chemical waste via Green Chemistry principles.
• Minimize single-use plastics in all R&D workflows.
• Optimize ultra-low temperature (ULT) freezers, which can consume 16 to 22 kWh of energy daily.

Energy consumption of large-scale computational biology platforms is a concern.

CGEN is a pioneer in predictive computational target discovery powered by AI/ML, which means its energy footprint is shifting from wet-lab bench space to data center server racks. This is a critical, emerging risk. Data centers housing these computational platforms can consume between 96 and 144 kWh per day for a single server rack, and the energy demands of AI are projected to reach 23 gigawatts globally by the end of 2025, surpassing Bitcoin mining. That's a huge surge.

This massive energy appetite is not just an operational cost; it is a carbon footprint multiplier. CGEN's reliance on these platforms for target identification (like PVRIG and TIGIT) means they must prioritize cloud providers or data center partners that can demonstrate a high percentage of renewable energy use. The carbon cost of every computational run needs to be factored into the R&D budget.

Clinical trial supply chain's carbon footprint faces increasing investor scrutiny.

This is arguably CGEN's most immediate and quantifiable environmental risk. The Sustainable Markets Initiative Health Systems Task Force, which includes major pharma partners, committed to measuring and reporting emissions for all Phase 2 and Phase 3 clinical trials starting in 2025. This is a hard deadline.

A single Phase 3 clinical trial can produce up to 3,000 metric tons of carbon dioxide equivalent gases (CO2e). CGEN's partner, AstraZeneca, has expanded its rilvegostomig program (which uses CGEN's TIGIT component) to ten Phase 3 trials. Here's the quick math on the potential exposure, assuming CGEN's trials follow the industry benchmark:

Trial Type	CGEN/Partner Trials (as of 2025)	Est. CO2e per Trial (Metric Tons)	Total Est. CO2e Exposure (Metric Tons)
Phase 3 (Rilvegostomig)	10 (AstraZeneca-led)	3,000	30,000
Phase 2 (COM701)	Multiple ongoing	~1,000 (Conservative est.)	N/A (Variable)

This exposure is primarily driven by drug shipment logistics, patient travel, and site energy use. CGEN must ensure its collaboration agreements include clear environmental reporting requirements from its partners to manage this Scope 3 (value chain) emissions risk.

Environmental impact assessments are now standard for new manufacturing facilities.

For a clinical-stage company like CGEN, this is a future opportunity and a compliance hurdle. The trend in 2025, driven partly by U.S. regulatory shifts, is to tighten environmental review for new pharmaceutical manufacturing facilities. The Environmental Protection Agency (EPA) is now the lead agency for coordinating and permitting facilities requiring an Environmental Impact Statement (EIS).

If CGEN were to move toward commercial-scale production or in-source manufacturing for its lead assets, a comprehensive Environmental Impact Assessment (EIA) would be a standard, multi-year, and costly requirement. This makes relying on Contract Manufacturing Organizations (CMOs) with established, compliant, and increasingly sustainable facilities a defintely prudent near-term strategy.