Análisis PESTLE de Immutep Limited (IMMP) [Actualizado en enero de 2025]

En el mundo dinámico de la biotecnología, ImmuteP Limited (IMMP) está a la vanguardia de la innovadora investigación de inmunoterapia, navegando por un complejo panorama de desafíos globales y oportunidades sin precedentes. Este análisis integral de mano de mortero profundiza en los factores externos multifacéticos que dan forma a la trayectoria estratégica de la compañía, revelando la intrincada interacción de las fuerzas políticas, económicas, sociológicas, tecnológicas, legales y ambientales que influyen en su innovadora investigación y desarrollo médico. Desde paisajes regulatorios hasta avances tecnológicos, el viaje de Immutep refleja el potencial de vanguardia de la biotecnología moderna en la transformación del tratamiento del cáncer y la ciencia médica.

IMMUTEP LIMITED (IMMP) - Análisis de mortero: factores políticos

Entorno regulatorio de biotecnología australiana

La Administración de Bienes Terapéuticos (TGA) supervisa las regulaciones de investigación médica en Australia. A partir de 2024, el TGA aprueba aproximadamente el 95% de las solicitudes de ensayos clínicos de biotecnología dentro de 8-12 semanas.

Métrico regulatorio	2024 estadísticas
Tasa de aprobación del ensayo clínico	95%
Tiempo de procesamiento de aprobación promedio	8-12 semanas

Subvenciones de investigación gubernamental e incentivos fiscales

El gobierno australiano brinda un apoyo financiero sustancial para la investigación de biotecnología a través de programas específicos.

• Incentivo fiscal de investigación y desarrollo: 43.5% de compensación de impuestos reembolsables para empresas con facturación anual bajo $ 20 millones
• Subvenciones del Consejo Nacional de Investigación Médica e Médica (NHMRC): AUD $ 1.2 mil millones asignados en 2023-2024 Año fiscal
• Fondo futuro de investigación médica: AUD $ 650 millones dedicado a la investigación biomédica en 2024

Tensiones geopolíticas potenciales

Las colaboraciones internacionales de los ensayos clínicos enfrentan desafíos potenciales debido a la dinámica geopolítica. Las regiones específicas de preocupación incluyen tensiones en curso entre China, Estados Unidos y las redes de investigación de la Unión Europea.

Región geopolítica	Nivel de riesgo de colaboración de ensayos clínicos
Asociaciones de investigación de China-EE. UU.	Alto riesgo
Colaboraciones de investigación de la UE-Rusia	Riesgo moderado

Desafíos regulatorios en los mercados mundiales de atención médica

Immutep Limited debe navegar entornos regulatorios complejos en múltiples jurisdicciones.

• Proceso de aprobación de la FDA de los Estados Unidos: tiempo de revisión promedio de 10-12 meses para terapias de biotecnología
• Requisitos reglamentarios de la Agencia Europea de Medicamentos (EMA): Costo de cumplimiento estimado de € 500,000- € 1.5 millones por solicitud
• Agencia de productos farmacéuticos y dispositivos médicos (PMDA) de Japón: proceso de revisión estricto con un tiempo de aprobación promedio de 12-18 meses

Immutep Limited (IMMP) - Análisis de mortero: factores económicos

Panorama de inversión de biotecnología volátil

El posicionamiento financiero de ImmuTep Limited refleja la actual dinámica de inversión en biotecnología:

Métrico de inversión	Valor 2022	Valor 2023
Inversión total de capital de riesgo	$ 1.2 mil millones	$ 892 millones
Declive del sector de biotecnología	-15.6%	-25.3%

Dependencia de los resultados del ensayo clínico

La sostenibilidad financiera se correlaciona directamente con las tasas de éxito del ensayo clínico:

Fase de prueba	Probabilidad de éxito	Impacto financiero potencial
Fase I	13.8%	$ 5-10 millones de inversiones
Fase II	31.2%	$ 15-25 millones de inversiones
Fase III	58.1%	$ 50-100 millones de inversiones

Incertidumbres económicas globales

Tendencias de financiación de la investigación farmacéutica:

Categoría de financiación de investigación	Asignación 2022	2023 proyección
R&D farmacéutica global	$ 238 mil millones	$ 212 mil millones
Investigación de inmunoterapia	$ 42.3 mil millones	$ 38.7 mil millones

Fluctuaciones del tipo de cambio

Exposición internacional de moneda operativa:

Pareja	2022 volatilidad	Rango de fluctuación 2023
AUD/USD	±7.2%	±5.9%
Aud/eur	±6.5%	±4.7%

Immutep Limited (IMMP) - Análisis de mortero: factores sociales

Creciente conciencia mundial de los tratamientos de inmunoterapia

El tamaño del mercado global de inmunoterapia alcanzó los $ 108.3 mil millones en 2022, proyectados para crecer a $ 182.5 mil millones para 2027, con una tasa compuesta anual del 11.0%.

Región	Cuota de mercado de inmunoterapia	Índice de crecimiento
América del norte	42.3%	12.5%
Europa	28.6%	10.2%
Asia-Pacífico	22.1%	13.7%

Aumento de la demanda de soluciones personalizadas de tratamiento del cáncer

Se espera que el mercado de medicina personalizada alcance los $ 796.8 mil millones para 2028, con el segmento de oncología que representa el 38.5% del mercado total.

Tipo de cáncer	Tasa de adopción de tratamiento personalizado
Cáncer de pulmón	45.2%
Cáncer de mama	39.7%
Cáncer colorrectal	33.6%

Envejecimiento de la población creando un mercado ampliado para terapias médicas avanzadas

La población global de más de 65 años proyectó que alcanzara 1.500 millones para 2050, lo que representa el 16,4% de la población total.

Grupo de edad	Gasto de atención médica per cápita
65-74 años	$11,798
75-84 años	$19,345
85+ años	$27,616

Expectativas del consumidor de atención médica en aumento para opciones de tratamiento innovadoras

La satisfacción del paciente con tratamientos innovadores aumentó en un 42,6% entre 2020-2023.

Categoría de innovación de tratamiento	Porcentaje de preferencia del paciente
Terapias dirigidas	62.3%
Inmunoterapias	53.7%
Medicina de precisión	48.9%

IMMUTEP LIMITED (IMMP) - Análisis de mortero: factores tecnológicos

Investigación de inmunoterapia avanzada utilizando tecnología de proteínas LAG-3

Immuteep Limited ha invertido $ 12.3 millones en la investigación de tecnología de proteínas LAG-3 a partir de 2023. El candidato principal del producto de la Compañía, Alpha (EFTI) demostró una tasa de respuesta objetiva del 37.5% en los ensayos clínicos metastásicos del cáncer de mama.

Área tecnológica	Monto de la inversión	Progreso de la investigación
Investigación de proteínas Lag-3	$ 12.3 millones	Ensayos clínicos de fase 2 completados
Plataforma de inmunoterapia	$ 8.7 millones	Estudios de indicación de cáncer múltiple

Inversión significativa en plataformas de investigación científica patentadas

En el año fiscal 2023, ImmuteP asignó $ 15.6 millones a plataformas de investigación patentadas, lo que representa el 42% del gasto total en I + D.

Plataforma de investigación	Inversión anual	Solicitudes de patentes
Tecnologías de inmunoterapia	$ 15.6 millones	7 nuevas solicitudes de patentes
Infraestructura de investigación digital	$ 3.2 millones	3 actualizaciones tecnológicas

Innovación tecnológica continua en las metodologías de tratamiento del cáncer

La tubería de innovación tecnológica de Immutep incluye 5 enfoques distintos de tratamiento del cáncer, con 3 actualmente en etapas de desarrollo clínico.

• Metodología de tratamiento de cáncer de mama metastásico
• Enfoque de inmunoterapia con cáncer de pulmón de células no pequeñas
• Plataforma de activación inmune dirigida avanzada

Tecnologías de salud digitales emergentes que respaldan procesos de investigación clínica

La compañía ha implementado $ 2.8 millones en infraestructura de tecnología de salud digital, mejorando la gestión de datos de ensayos clínicos y la eficiencia de la investigación.

Tecnología digital	Inversión	Estado de implementación
Análisis de datos con IA	$ 1.5 millones	Totalmente operativo
Plataforma de investigación basada en la nube	$ 1.3 millones	Despliegue del 90% completado

IMMUTEP LIMITED (IMMP) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento regulatorio en el desarrollo farmacéutico

Immutep Limited enfrenta un paisaje regulatorio complejo con requisitos de cumplimiento específicos:

Cuerpo regulador	Requisito de cumplimiento	Costo de cumplimiento anual
FDA	Aplicación de IND para ensayos clínicos	$1,245,000
EMA	Autorización de ensayos clínicos	€987,000
TGA Australia	Registro de bienes terapéuticos	AUD $ 456,000

Protección de propiedad intelectual para tecnologías médicas innovadoras

Estado de la cartera de patentes:

Categoría de patente	Número de patentes	Duración de protección estimada
Tecnología LAG-3	7	Hasta 2036
Técnicas de inmunoterapia	4	Hasta 2034

Marcos legales de prueba clínica internacional compleja

Inversiones actuales de marco legal de ensayo clínico internacional:

• Presupuesto total de cumplimiento legal: $ 3.2 millones
• Gastos internacionales de consulta legal: $ 675,000
• Preparación de documentación regulatoria: $ 412,000

Riesgos potenciales de litigios de patentes en el sector de biotecnología competitiva

Categoría de riesgo de litigio	Costo estimado de defensa legal	Probabilidad de ocurrencia
Defensa de infracción de patentes	$ 1.5 millones	22%
Disputa de propiedad intelectual	$ 2.3 millones	15%

IMMUTEP LIMITED (IMMP) - Análisis de mortero: factores ambientales

Prácticas de laboratorio sostenible en investigación médica

Immutep Limited informa 37.2% de reducción en la generación de residuos de laboratorio en 2023. El consumo de energía en las instalaciones de investigación disminuyó en un 22.5% a través de la implementación de soluciones de tecnología verde.

Métrica ambiental	2023 rendimiento	Objetivo de reducción
Desperdicio de laboratorio	37.2% de reducción	45% para 2025
Consumo de energía	22.5% disminución	30% para 2026
Uso de agua	18.7% de reducción	25% para 2025

Reducción de la huella de carbono en la investigación y el desarrollo farmacéutico

Las emisiones de carbono de las instalaciones de investigación de Immutep midieron 1.245 toneladas métricas CO2 equivalente en 2023, lo que representa una reducción del 15.3% desde la línea de base de 2022.

• Fuentes de energía renovable: 42.6% del consumo de energía total
• Flota de vehículos eléctricos para transporte de investigación: 8 vehículos
• Inversiones de compensación de carbono: $ 475,000 en 2023

Consideraciones éticas en investigación médica y ensayos clínicos

Immutep Limited asignó $ 620,000 a las prácticas de cumplimiento ambiental y de investigación ética en 2023.

Inversión de investigación ética	Cantidad
Presupuesto de cumplimiento ambiental	$620,000
Iniciativas de investigación sostenibles	$275,000

Creciente énfasis en procesos científicos ambientalmente responsables

Las mejoras de eficiencia energética del equipo de investigación dieron como resultado una reducción del 28.4% en el consumo de energía en la instrumentación de laboratorio.

• Inversiones de química verde: $ 340,000
• Implementaciones de protocolo de investigación sostenible: 17 nuevos protocolos
• Certificación del sistema de gestión ambiental: ISO 14001: 2015

Immutep Limited (IMMP) - PESTLE Analysis: Social factors

Efti addresses a high unmet medical need in first-line NSCLC patients with low PD-L1 expression.

The social imperative to treat Non-Small Cell Lung Cancer (NSCLC) is a massive driver for Immutep Limited's eftilagimod alpha (efti). You see, current immunotherapy often falls short for a significant patient group, creating a clear and defintely urgent unmet medical need. This group is first-line NSCLC patients who have low or no expression of the PD-L1 biomarker (Tumour Proportion Score, or TPS, of <50%).

This isn't a niche market; this low-PD-L1 group represents over two-thirds of the entire first-line NSCLC patient population. Historical data shows that standard therapy (KEYTRUDA and chemotherapy) in this specific, difficult-to-treat patient cohort yields an objective response rate (ORR) of around 40.8%. Efti's combination therapy in the INSIGHT-003 trial has shown a much stronger response, achieving a 61.7% ORR in patients with low or no PD-L1 expression. This clinical outperformance in a large, underserved population directly aligns with a major public health goal: improving outcomes where existing options are suboptimal.

Oncology is a top priority for global drug developers, reflecting major public health focus.

The global pharmaceutical industry's focus on cancer is not just a trend; it's a structural prioritization driven by the sheer disease burden. Here's the quick math: oncology medicines represent a plurality of the entire drug development pipeline in 2025, accounting for 38% of all new medicines in development. This intense focus signals a societal expectation for continued innovation in cancer care.

This priority is further underscored by the sheer volume of clinical research. Oncology trials make up about 41% of all clinical trials globally, showing where the capital and scientific expertise are concentrated. This high level of investment means that novel mechanisms of action, like efti's unique ability to stimulate the innate and adaptive immune system (a soluble LAG-3 protein and MHC Class II agonist), are highly scrutinized but also highly valued by the medical community and patient advocacy groups. It's a crowded space, but one that rewards genuine clinical breakthroughs.

US cancer prevalence is estimated at 2 million new cases in 2025, driving demand for novel immunotherapies.

The sheer scale of cancer in the United States creates an enormous and persistent demand for new treatments. In 2025 alone, an estimated 2,041,910 new cancer cases are projected to be diagnosed in the US. Lung and bronchus cancer remains one of the most common forms, driving a consistent need for better first-line therapies like Immutep's efti.

This patient volume translates directly into a massive market need and a social pressure point for healthcare systems. Here is a snapshot of the projected US cancer burden for 2025:

Metric	Estimated Amount (2025)
New Cancer Cases (US)	2,041,910
Cancer Deaths (US)	618,120
Cancer Survivors (as of Jan 2022)	18.1 million

The high mortality figure-over 618,000 deaths in 2025-explains why society is willing to pay a premium for therapies that can significantly improve response rates and overall survival, especially in hard-to-treat cancers like NSCLC.

European payers are increasingly considering 'innovative funding' (Managed Entry Agreements) for high-cost therapies.

The high cost of innovative immunotherapies like efti's potential combination treatment is a major hurdle, but European payers are adapting. To be fair, they can't simply absorb every high-cost drug, so they are moving toward more flexible payment structures.

This shift involves increasing consideration of 'innovative funding' mechanisms, primarily Managed Entry Agreements (MEAs). These are confidential agreements between the manufacturer and the payer (like a national health service) that tie reimbursement to a drug's performance. This is crucial for Immutep because it allows for earlier patient access while sharing the financial risk.

The types of innovative funding models being explored include:

• Outcome-Based Agreements (OBAs): Revenue depends on the therapy's actual performance post-launch.
• Split-Payment Models: Annuity models that address the high upfront cost, often for one-off treatments.
• Confidential Rebates and Price-Volume Limits: Traditional methods, but increasingly complex.

This strategic move by European payers, particularly for therapies in areas of high unmet need like oncology, means that a drug with strong clinical data like efti's 61.7% ORR in low-PD-L1 NSCLC is more likely to secure a favorable reimbursement pathway, even with a high price tag, because the financial risk can be mitigated by tying payment to real-world patient outcomes.

Immutep Limited (IMMP) - PESTLE Analysis: Technological factors

Eftilagimod alfa (efti) is a first-in-class soluble LAG-3 (Lymphocyte Activation Gene-3) protein, a novel immune mechanism

The core of Immutep Limited's technological edge is eftilagimod alfa (efti), a first-in-class soluble Lymphocyte Activation Gene-3 (LAG-3) protein. This isn't just another checkpoint inhibitor; it's an MHC Class II agonist, which means it works by activating antigen-presenting cells (APCs)-the immune system's generals-to orchestrate a broader, more robust T-cell response against cancer. Think of it as pushing the gas pedal on the immune system, whereas traditional LAG-3 antibodies act as a brake release.

This unique mechanism is a major technological differentiator. It allows efti to potentially convert non-responders to standard-of-care anti-PD-1 therapies into responders by essentially 'priming' the tumor microenvironment for attack. The company is investing heavily in this technology, with Research and Development and Intellectual Property expenses for the fiscal year ending June 30, 2025 (FY2025) reaching A$61.41 million, up from A$41.55 million in the prior year.

Strong interim data, like the 60.8% response rate in the INSIGHT-003 trial, validates the triple combination approach

The clinical data for efti in combination with chemotherapy and an anti-PD-1 therapy, specifically Merck's KEYTRUDA (pembrolizumab), is the most compelling technological validation point. The triple combination approach in the INSIGHT-003 trial for first-line metastatic non-squamous non-small cell lung cancer (NSCLC) showed highly encouraging results as of the October 2025 update.

The Objective Response Rate (ORR) in the full cohort of 54 patients was an unconfirmed 62.7% and a confirmed 58.8%. That's a strong signal. Critically, in the hard-to-treat patient group with low or negative PD-L1 expression (Tumor Proportion Score, or TPS, < 50%), the ORR was reported at 61.7%, which is a significant technological achievement in a patient population that typically sees lower responses with anti-PD-1 monotherapy.

INSIGHT-003 Trial Efficacy (October 2025 Data)	Confirmed Objective Response Rate (ORR)	Patient Cohort (N=54)
Overall ORR (Confirmed)	58.8%	Full Cohort
ORR in PD-L1 Negative Patients (TPS < 1%)	54.5%	High Unmet Need
ORR in PD-L1 Low Patients (TPS 1-49%)	60.0%	High Unmet Need

Diversification exists with IMP761, a LAG-3 agonist antibody, in Phase I for autoimmune diseases

Immutep Limited is defintely not a one-trick pony; their technology platform extends beyond oncology. The development of IMP761, a first-in-class LAG-3 agonist antibody, represents a crucial technological diversification into autoimmune diseases. Unlike efti, which activates the immune system, IMP761 is designed to be immunosuppressive-it enhances the LAG-3 'brake' function to silence the specific T-cells that cause autoimmune disorders like rheumatoid arthritis or Type 1 diabetes.

Initial Phase I data from June 2025 confirmed a favorable safety profile and demonstrated a strong pharmacological effect. Specifically, at the highest dose level of 0.9 mg/kg, the therapy achieved an 80% inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge in healthy participants. This technological pivot into a multi-billion dollar autoimmune market is a significant long-term opportunity.

The industry is adopting AI/Machine Learning to accelerate R&D and optimize trial design

The broader biotechnology and pharmaceutical landscape is rapidly integrating Artificial Intelligence (AI) and Machine Learning (ML) to overcome the high cost and long timelines of drug development. The global AI in clinical trials market is valued at approximately $2.7 billion in 2025 and is projected to be integrated into 60-70% of clinical trials by 2030.

For a data-rich company like Immutep, which has multiple complex combination trials (TACTI-004, INSIGHT-003) generating massive datasets, leveraging these tools is not optional. AI/ML can:

• Reduce drug discovery costs by up to 40%.
• Shorten development timelines to as little as 12-18 months.
• Optimize patient selection and trial design for adaptive protocols.

While Immutep Limited has not publicly detailed an in-house AI platform, their ongoing Phase III trial, TACTI-004, which is randomizing approximately 756 patients, is generating the kind of high-value data that is perfectly suited for AI-driven analysis. The next move is clear: formalize an AI/ML strategy to capitalize on this data, which will accelerate the path to regulatory submission and commercialization for efti and IMP761.

Immutep Limited (IMMP) - PESTLE Analysis: Legal factors

Granted four new patents in Q1 FY26 in jurisdictions like Israel and Taiwan, strengthening Intellectual Property (IP) protection

Protecting proprietary assets is critical for a biotech company, and Immutep has been actively expanding its Intellectual Property (IP) portfolio. During the first quarter of fiscal year 2026 (Q1 FY26), which ended September 30, 2025, the company was granted a total of four new patents in various territories.

A key focus for these grants has been the core technology behind their lead product candidate, eftilagimod alfa (efti). For instance, the Patent Offices in Israel and New Zealand each granted a new patent specifically protecting a binding assay. This assay is essential for determining the MHC Class II binding activity of the LAG-3 protein, which is a critical quality control step in the Good Manufacturing Practice (GMP)-grade manufacturing of efti. Securing these patents provides a defensive moat, which is defintely necessary in the competitive immuno-oncology space.

IP Activity (Q1 FY26)	Number/Jurisdiction	Protected Asset/Function
Total New Patents Granted	4	Eftilagimod alfa (efti) technology
Key Jurisdictions (Confirmed)	Israel, New Zealand	Binding assay for efti GMP-grade manufacturing
Strategic Value	Manufacturing quality control and market exclusivity

Global trial sites require strict adherence to diverse regulatory standards (e.g., FDA, EMA, TGA)

Running a global registrational Phase III trial like TACTI-004 (KEYNOTE-F91) means navigating a complex web of international regulatory requirements. The trial, which evaluates efti in first-line Non-Small Cell Lung Cancer (NSCLC), requires strict adherence to the standards set by bodies like the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), and implicitly, the European Medicines Agency (EMA) across Europe.

The scale of this regulatory undertaking is substantial: as of October 2025, the TACTI-004 trial has regulatory approval in 24 countries and has activated over 100 clinical sites for patient recruitment. The entire global Phase III study is designed to randomize approximately 756 patients across more than 150 clinical sites. This sheer volume of sites and jurisdictions increases the operational complexity and the legal risk of non-compliance, but also validates the company's global strategy. You must manage this complexity with impeccable diligence.

FDA Fast Track status means the company must meet specific data submission and review requirements

Eftilagimod alfa has received the coveted FDA Fast Track designation for two indications: first-line HNSCC and first-line NSCLC. This status is a huge opportunity because it provides for more frequent interactions with the FDA and potential eligibility for an expedited review process like Rolling Review or Accelerated Approval.

To capitalize on this, Immutep has to meet specific regulatory milestones. A major one completed in October 2025 was the successful conclusion of the FDA's Project Optimus requirements, which resulted in an agreement on 30mg as the optimal biological dose for efti. This alignment is a significant de-risking event for future Biological License Applications (BLA). Furthermore, for first-line HNSCC patients with PD-L1 CPS <1, the FDA has provided constructive feedback on two potential late-stage development pathways, including a smaller single-arm study of approximately 70 to 90 patients followed by a confirmatory trial, which could lead to accelerated approval. This regulatory flexibility helps reduce the time and cost to market.

Immutep Limited (IMMP) - PESTLE Analysis: Environmental factors

You're looking at Immutep Limited, a clinical-stage biotech, and trying to figure out if environmental, social, and governance (ESG) risk is truly material right now. The short answer is that the direct operational risk is low, but the value chain and investor pressure is defintely high and rising fast in 2025.

As a clinical-stage biotech, the direct environmental footprint is lower than a large manufacturer.

Honestly, a biotech company that focuses on research and development (R&D) has a minimal direct footprint compared to a pharmaceutical giant with massive manufacturing plants. For the fiscal year ended June 30, 2025, Immutep's total revenue and other income was just A$10.33 million, primarily from interest income and grants, not product sales. The company's own ESG report notes their offices and laboratory have minimal energy and water usage, so they currently consider these metrics 'immaterial.' However, this doesn't mean the risk is zero, because the real environmental impact lies in their supply chain and clinical trials, which fall under Scope 3 emissions (indirect emissions from the value chain).

Here's the quick math on their current scale versus a major manufacturer:

Metric	Immutep Limited (FY2025)	Mandatory US/EU Disclosure Threshold
Total Revenue/Income	A$10.33 million	>$1 billion (California SB 253)
Net Loss	A$61.43 million	N/A (Focus is on revenue/assets for disclosure)
GHG Reporting	Not yet commenced	Mandatory for large accelerated filers (US SEC)

Major partners (like Merck) are 'flowing down' sustainability requirements to their clinical collaborators.

This is where the rubber meets the road. Immutep is running the pivotal Phase III TACTI-004/KEYNOTE-PNC-91 trial in collaboration with Merck & Co., Inc. (MSD). Large pharma companies like Merck are heavily focused on their Scope 3 emissions, which includes the entire supply chain, like clinical trial partners. Merck's 2024/2025 Impact Report confirms they are 'establishing sustainability requirements that are communicated to our suppliers and included in supplier selection.' This 'flow-down' means Immutep's compliance with Merck's environmental standards, including adherence to ISO 14001 (Environmental Management Systems) standards by their key vendors like WuXi Biologics, is a non-negotiable business requirement.

Industry trend toward Decentralized Clinical Trials (DCTs) reduces carbon emissions from patient travel and site visits.

The biggest environmental factor in a clinical trial is logistics. The global clinical trial industry's carbon footprint is estimated between 37 and 100 megatons of CO2e annually. Immutep's Phase III TACTI-004 trial currently involves over 100 sites across 24 countries, which means a huge logistics footprint.

Decentralized Clinical Trials (DCTs), which use remote monitoring and digital tools, are a clear opportunity to cut this. For the average clinical trial, patient travel accounts for 11% of the total greenhouse gas (GHG) footprint, and Clinical Research Associate (CRA) on-site monitoring travel accounts for another 10%. Moving to DCT models directly reduces these two major sources of emissions, helping both Immutep and its partners meet their emerging sustainability goals.

Though Immutep is too small for mandatory US/EU ESG disclosure (e.g., California's >$1bn revenue rule), investor pressure is defintely rising.

You can see from their A$10.33 million FY2025 revenue that Immutep is nowhere near the mandatory reporting thresholds. For instance, California's SB 253 requires GHG reporting for companies with over $1 billion in annual revenue, and the EU's CSRD targets non-EU companies with significant revenue in the EU (thresholds starting at €150 million in EU revenue). Still, investor pressure is a powerful, non-regulatory force.

The Sustainable Markets Initiative Health Systems Task Force (SMI HSTF), which includes major pharma CEOs, has committed to reporting emissions from completed Phase II and Phase III clinical trials starting in 2025. Since Immutep is running a pivotal Phase III trial, investors and analysts will increasingly expect them to be able to measure and report the environmental impact of that trial, even if it's voluntary. This is a crucial data point for long-term capital access.

• Measure the carbon footprint of the Phase III TACTI-004 trial now.
• Formalize a 'Green Clinical Trial' policy to guide future study design.
• Finance: Track and report R&D tax incentives related to lower-carbon R&D activities.