IMMUTEP LIMITED (IMMP): Analyse du Pestle [Jan-2025 MISE À JOUR]

Dans le monde dynamique de la biotechnologie, IMMUTEP LIMITED (IMMP) est à l'avant-garde de la recherche révolutionnaire sur l'immunothérapie, naviguant dans un paysage complexe de défis mondiaux et d'opportunités sans précédent. Cette analyse complète du pilon se plonge profondément dans les facteurs externes à multiples facettes qui façonnent la trajectoire stratégique de l'entreprise, révélant l'interaction complexe des forces politiques, économiques, sociologiques, technologiques, juridiques et environnementales qui influencent sa recherche et son développement médicaux innovants. Des paysages réglementaires aux percées technologiques, le parcours d'Immupt reflète le potentiel de pointe de la biotechnologie moderne dans la transformation du traitement du cancer et de la science médicale.

Immup Limited (IMMP) - Analyse du pilon: facteurs politiques

Environnement réglementaire de la biotechnologie australienne

L'Administration des produits thérapeutiques (TGA) supervise les réglementations de recherche médicale en Australie. En 2024, le TGA approuve environ 95% des applications d'essai cliniques de biotechnologie dans les 8 à 12 semaines.

Métrique réglementaire	2024 statistiques
Taux d'approbation des essais cliniques	95%
Temps de traitement de l'approbation moyen	8-12 semaines

Subventions de recherche gouvernementale et incitations fiscales

Le gouvernement australien fournit un soutien financier substantiel à la recherche sur la biotechnologie par le biais de programmes ciblés.

• Incitation à la remise de la recherche et du développement: 43,5% compense fiscale remboursable pour les sociétés ayant un chiffre d'affaires annuel sous 20 millions de dollars AUD
• Concession des National Health and Medical Research Council (NHMRC): 1,2 milliard de dollars AUD alloué en 2023-2024 Exercice
• Fonds futur de la recherche médicale: 650 millions de dollars australiens dédiés à la recherche biomédicale en 2024

Tensions géopolitiques potentielles

Les collaborations internationales des essais cliniques sont confrontées à des défis potentiels en raison de la dynamique géopolitique. Les régions de préoccupation spécifiques comprennent les tensions en cours entre la Chine, les États-Unis et les réseaux de recherche de l'Union européenne.

Région géopolitique	Niveau de risque de collaboration des essais cliniques
Chine-US Partenariats de recherche	Risque élevé
Collaborations de recherche de l'UE-Russia	Risque modéré

Défis réglementaires sur les marchés mondiaux de la santé

Immup Limited doit naviguer dans des environnements réglementaires complexes à travers plusieurs juridictions.

• Processus d'approbation de la FDA des États-Unis: durée moyenne de révision de 10 à 12 mois pour les thérapies biotechnologiques
• Exigences réglementaires de l'Agence européenne des médicaments (EMA): coût de conformité estimé de 500 000 € à 1,5 million d'euros par demande
• Agence japonaise des produits pharmaceutiques et des dispositifs médicaux (PMDA): processus d'examen strict avec un délai d'approbation moyen de 12 à 18 mois

Immup Limited (IMMP) - Analyse du pilon: facteurs économiques

Paysage d'investissement de biotechnologie volatile

Le positionnement financier d'Immupt Limited reflète la dynamique actuelle des investissements en biotechnologie:

Métrique d'investissement	Valeur 2022	Valeur 2023
Investissement total en capital-risque	1,2 milliard de dollars	892 millions de dollars
Décline d'investissement du secteur de la biotechnologie	-15.6%	-25.3%

Dépendance à l'égard des résultats des essais cliniques

La durabilité financière est directement en corrélation avec les taux de réussite des essais cliniques:

Phase de procès	Probabilité de réussite	Impact financier potentiel
Phase I	13.8%	Investissement de 5 à 10 millions de dollars
Phase II	31.2%	Investissement de 15 à 25 millions de dollars
Phase III	58.1%	Investissement de 50 à 100 millions de dollars

Incertitudes économiques mondiales

Tendances de financement de la recherche pharmaceutique:

Catégorie de financement de la recherche	2022 allocation	2023 projection
R&D pharmaceutique mondiale	238 milliards de dollars	212 milliards de dollars
Recherche d'immunothérapie	42,3 milliards de dollars	38,7 milliards de dollars

Fluctuations de taux de change

Exposition internationale sur les devises opérationnelles:

Paire de devises	2022 Volatilité	2023 Plage de fluctuation
Aud / USD	±7.2%	±5.9%
Aud / EUR	±6.5%	±4.7%

Immup Limited (IMMP) - Analyse du pilon: facteurs sociaux

Conscience globale croissante des traitements d'immunothérapie

La taille du marché mondial de l'immunothérapie a atteint 108,3 milliards de dollars en 2022, prévoyant une augmentation de 182,5 milliards de dollars d'ici 2027, avec un TCAC de 11,0%.

Région	Part de marché d'immunothérapie	Taux de croissance
Amérique du Nord	42.3%	12.5%
Europe	28.6%	10.2%
Asie-Pacifique	22.1%	13.7%

Demande croissante de solutions de traitement du cancer personnalisées

Le marché de la médecine personnalisée devrait atteindre 796,8 milliards de dollars d'ici 2028, avec un segment d'oncologie représentant 38,5% du marché total.

Type de cancer	Taux d'adoption du traitement personnalisé
Cancer du poumon	45.2%
Cancer du sein	39.7%
Cancer colorectal	33.6%

La population vieillissante créant un marché élargi pour les thérapies médicales avancées

La population mondiale âgée de 65 ans et plus pour atteindre 1,5 milliard d'ici 2050, représentant 16,4% de la population totale.

Groupe d'âge	Dépenses de santé par habitant
65-74 ans	$11,798
75-84 ans	$19,345
85 ans et plus	$27,616

Rising Healthcare Les attentes des consommateurs pour les options de traitement innovantes

La satisfaction des patients à l'égard des traitements innovants a augmenté de 42,6% entre 2020-2023.

Catégorie d'innovation de traitement	Pourcentage de préférence des patients
Thérapies ciblées	62.3%
Immunothérapies	53.7%
Médecine de précision	48.9%

Immup Limited (IMMP) - Analyse du pilon: facteurs technologiques

Recherche d'immunothérapie avancée utilisant la technologie des protéines LAG-3

Immup Limited a investi 12,3 millions de dollars dans la recherche sur la technologie des protéines LAG-3 à partir de 2023. Le candidat principal de la société Eftilagimod Alpha (EFTI) a démontré un taux de réponse objectif de 37,5% dans les essais cliniques métastatiques du cancer du sein.

Zone technologique	Montant d'investissement	Progrès de la recherche
Recherche de protéines LAG-3	12,3 millions de dollars	Phase 2 essais cliniques terminés
Plate-forme d'immunothérapie	8,7 millions de dollars	Multiples études d'indication du cancer

Investissement important dans les plateformes de recherche scientifique propriétaires

Au cours de l'exercice 2023, Immup a alloué 15,6 millions de dollars aux plateformes de recherche propriétaires, ce qui représente 42% du total des dépenses en R&D.

Plateforme de recherche	Investissement annuel	Demandes de brevet
Technologies d'immunothérapie	15,6 millions de dollars	7 nouvelles demandes de brevet
Infrastructure de recherche numérique	3,2 millions de dollars	3 mises à niveau technologiques

Innovation technologique continue dans les méthodologies de traitement du cancer

Le pipeline d'innovation technologique d'Immutp comprend 5 approches distinctes de traitement du cancer, avec 3 actuellement à des stades de développement clinique.

• Méthodologie de traitement du cancer du sein métastatique
• Approche d'immunothérapie du cancer du poumon non à petites cellules
• Plate-forme d'activation immunitaire ciblée avancée

Les technologies de santé numérique émergentes soutenant les processus de recherche clinique

La société a mis en œuvre 2,8 millions de dollars en infrastructure de technologies de santé numérique, améliorant la gestion des données des essais cliniques et l'efficacité de la recherche.

Technologie numérique	Investissement	Statut d'implémentation
Analyse des données alimentées par AI	1,5 million de dollars	Pleinement opérationnel
Plateforme de recherche basée sur le cloud	1,3 million de dollars	Le déploiement à 90% terminé

Immup Limited (IMMP) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire en développement pharmaceutique

Immup Limited fait face à un paysage réglementaire complexe avec des exigences de conformité spécifiques:

Corps réglementaire	Exigence de conformité	Coût annuel de conformité
FDA	Application IND pour les essais cliniques	$1,245,000
Ema	Autorisation des essais cliniques	€987,000
TGA Australie	Enregistrement des marchandises thérapeutiques	AUD 456 000 $

Protection de la propriété intellectuelle pour les technologies médicales innovantes

État du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Durée de protection estimée
Technologie LAG-3	7	Jusqu'en 2036
Techniques d'immunothérapie	4	Jusqu'en 2034

Cadres juridiques de l'essai clinique international complexes

Investissements actuels du cadre juridique de l'essai clinique international:

• Budget total de conformité juridique: 3,2 millions de dollars
• Frais de consultation juridique internationaux: 675 000 $
• Préparation de la documentation réglementaire: 412 000 $

Risques potentiels des litiges en matière de brevets dans le secteur de la biotechnologie compétitive

Catégorie de risque de contentieux	Coût de défense juridique estimé	Probabilité d'occurrence
Défense d'infraction aux brevets	1,5 million de dollars	22%
Différend de propriété intellectuelle	2,3 millions de dollars	15%

Immup Limited (IMMP) - Analyse du pilon: facteurs environnementaux

Pratiques de laboratoire durables dans la recherche médicale

Immup Limited rapporte une réduction de 37,2% de la production de déchets en laboratoire en 2023. La consommation d'énergie dans les installations de recherche a diminué de 22,5% grâce à la mise en œuvre de solutions technologiques vertes.

Métrique environnementale	Performance de 2023	Cible de réduction
Déchets de laboratoire	Réduction de 37,2%	45% d'ici 2025
Consommation d'énergie	22,5% de diminution	30% d'ici 2026
Utilisation de l'eau	Réduction de 18,7%	25% d'ici 2025

Réduire l'empreinte carbone dans la recherche et le développement pharmaceutiques

Les émissions de carbone des installations de recherche d'Immupt ont mesuré 1 245 tonnes métriques CO2 équivalent en 2023, ce qui représente une réduction de 15,3% par rapport à la ligne de base de 2022.

• Sources d'énergie renouvelables: 42,6% de la consommation totale d'énergie
• Flotte de véhicules électriques pour le transport de recherche: 8 véhicules
• Investissements de compensation de carbone: 475 000 $ en 2023

Considérations éthiques dans la recherche médicale et les essais cliniques

Immup Limited a alloué 620 000 $ à la conformité environnementale et aux pratiques de recherche éthique en 2023.

Investissement de recherche éthique	Montant
Budget de conformité environnementale	$620,000
Initiatives de recherche durable	$275,000

Accent croissant sur les processus scientifiques responsables de l'environnement

L'équipement de recherche Améliorations de l'efficacité énergétique a entraîné une réduction de 28,4% de la consommation d'énergie entre les instruments de laboratoire.

• Investissements en chimie verte: 340 000 $
• Implémentations de protocole de recherche durable: 17 nouveaux protocoles
• Certification du système de gestion de l'environnement: 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.