Immutep Limited (IMMP): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la inmunoterapia contra el cáncer, ImmuteP Limited (IMMP) emerge como una compañía de biotecnología pionera que revoluciona los paradigmas de tratamiento a través de su innovadora tecnología de orientación LAG-3. Al aprovechar la investigación científica innovadora y las asociaciones estratégicas, ImmuteP está listo para transformar cómo abordamos el tratamiento del cáncer, ofreciendo posibles terapias innovadoras que prometen intervenciones más precisas y específicas con efectos secundarios reducidos. Su modelo de negocio único combina experiencia científica de vanguardia, redes de investigación colaborativa y un enfoque de desarrollo centrado en el paciente, colocando a la compañía a la vanguardia de las intervenciones inmunológicas de próxima generación.

IMMUTEP LIMITED (IMMP) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica colaboraciones

ImmuTep Limited ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de colaboración
Universidad de Southampton	Estudios de inmunoterapia	Asociación activa
Centro de cáncer de Peter MacCallum	Investigación relacionada con LAG-3	Investigación clínica en curso

Asociaciones de la compañía farmacéutica

Immutep tiene colaboraciones estratégicas con compañías farmacéuticas:

• Merck KGAA - Asociado para el desarrollo de Eftilagimod Alpha (EFTI)
• GSK - Colaboración sobre investigación inmuno -oncología

Organizaciones de investigación por contrato (CRO)

Nombre de Cro	Apoyo de ensayos clínicos	Proyectos actuales
Ícono plc	Gestión de ensayos de fase II/III	Ensayo clínico de información
Parexel International	Diseño de ensayo clínico	Estudios metastásicos del cáncer de mama

Agencias de financiación de investigación

Financiación del apoyo de agencias de investigación gubernamentales y privadas:

• National Health and Medical Research Council (NHMRC): proporcionó a AUD 750,000 en subvenciones de investigación
• Cancer Research UK - Iniciativas de investigación de inmunoterapia apoyadas

IMMUTEP LIMITED (IMMP) - Modelo de negocio: actividades clave

Desarrollo de nuevos tratamientos de inmunoterapia dirigidos a la proteína LAG-3

Immutep Limited se centra en desarrollar inmunoterapias innovadoras relacionadas con LAG-3. A partir de 2024, la compañía tiene:

Tipo de terapia	Etapa de desarrollo	Indicación objetivo
Eftilagimod alfa (Imp321)	Ensayos clínicos de fase 3	Cáncer de mama metastásico
Antibuerpos antagonistas de LAG-3	Desarrollo preclínico	Múltiples tipos de cáncer

Realización de ensayos preclínicos y clínicos para inmunoterapias contra el cáncer

Gastos de ensayos clínicos para 2023 Año fiscal: AU $ 18.4 millones

• Ensayos clínicos activos en múltiples indicaciones de cáncer
• Colaboración con instituciones de investigación internacionales
• Estudios clínicos de fase 2 y fase 3 en curso

Investigación y desarrollo de anticuerpos terapéuticos

I + D Métrica	Valor 2023
Gastos totales de I + D	Au $ 22.7 millones
Personal de I + D	36 investigadores especializados

Desarrollo de patentes y gestión de propiedad intelectual

Cartera de patentes a partir de 2024:

• 18 patentes otorgadas en todo el mundo
• 12 solicitudes de patentes pendientes
• Propiedad intelectual que cubre plataformas de tecnología LAG-3

Desarrollo de negocios estratégicos y negociaciones de licencias

Asociación	Estado	Valor potencial
Colaboración Merck KGAA	Activo	Hasta 93 millones de euros en pagos potenciales de hitos
Acuerdo de licencia de Novartis	Discusiones en curso	Términos financieros no revelados

IMMUTEP LIMITED (IMMP) - Modelo de negocio: recursos clave

Plataforma de tecnología LAG-3 patentada

La plataforma de tecnología central de Immutep se centró en la tecnología de punto de control inmune LAG-3. A partir de 2024, la compañía ha desarrollado múltiples candidatos terapéuticos en etapa clínica dirigida a la vía LAG-3.

Activo tecnológico	Etapa de desarrollo	Aplicaciones potenciales
Eftilagimod alfa (Imp321)	Ensayos clínicos de fase 3	Cáncer de mama metastásico
Imp761	Ensayos clínicos de fase 1	Enfermedades autoinmunes

Equipo de Investigación y Desarrollo Científico

Immutep mantiene un equipo de investigación especializado con experiencia en inmunoterapia y tecnología LAG-3.

• Personal total de I + D: aproximadamente 35-40 personal científico
• Investigadores a nivel de doctorado: aproximadamente 20-25 miembros del equipo
• Lugares de investigación global: Australia y Francia

Cartera de propiedades intelectuales

Protección de patentes robusta para la plataforma de tecnología LAG-3.

Categoría de patente	Número de patentes activas	Cobertura geográfica
Tecnología LAG-3	15-20 familias de patentes	Estados Unidos, Europa, Australia

Datos de ensayos clínicos y capacidades de investigación

Experiencia de ensayo clínico extenso en múltiples indicaciones oncológicas.

• Ensayos clínicos activos: 4-5 estudios concurrentes
• Inscripción acumulativa del paciente: más de 300 pacientes
• Fases de prueba: fase 1, fase 2 y fase 3

Experiencia en inmunoterapia especializada

Las asociaciones estratégicas y las colaboraciones mejoran las capacidades tecnológicas.

Socio de colaboración	Área de enfoque	Estado de asociación
Merck KGAA	Investigación de inmunoterapia	Alianza estratégica en curso
Gsk	Desarrollo clínico	Acuerdo de investigación colaborativa

ImmuteP Limited (IMMP) - Modelo de negocio: propuestas de valor

Innovadora inmunoterapia contra el cáncer dirigida a la proteína LAG-3

Immutep Limited se centra en el desarrollo de Eftilagimod alfa (EFTI), una nueva proteína LAG-3 Terapéutica dirigida a la inmunoterapia contra el cáncer. A partir de 2023, el candidato de producto principal de la compañía ha demostrado potencial en múltiples ensayos clínicos.

Producto	Etapa de desarrollo	Indicación objetivo
Eftilagimod alfa (EFTI)	Ensayos clínicos de fase 3	Cáncer de mama metastásico
Eftilagimod alfa (EFTI)	Ensayos clínicos de fase 2	Cáncer de pulmón de células no pequeñas

Posibles tratamientos innovadores para múltiples tipos de cáncer

El enfoque terapéutico de Immutep se dirige a múltiples tipos de cáncer a través de la modulación de proteínas LAG-3.

• Cáncer de mama metastásico
• Cáncer de pulmón de células no pequeñas
• Carcinoma de células escamosas de cabeza y cuello
• Cáncer de ovario

Enfoque de medicina de precisión para el tratamiento del cáncer

La estrategia de medicina de precisión de la compañía se centra en intervenciones inmunológicas dirigidas con mecanismos moleculares específicos.

Característica de medicina de precisión	Enfoque inmutep
Orientación molecular	Modulación de proteínas LAG-3
Tratamiento personalizado	Personalización de inmunoterapia

Mejores resultados del paciente a través de intervenciones inmunológicas dirigidas

Los datos clínicos de Immutep demuestran mejoras potenciales en las tasas de respuesta al tratamiento y supervivencia del paciente.

• Activación mejorada del sistema inmune
• Progresión tumoral reducida
• Potencial de supervivencia más larga del paciente

Nuevas soluciones terapéuticas con efectos secundarios reducidos

El alfa de Eftilagimod representa un enfoque de tratamiento de cáncer potencialmente menos invasivo en comparación con las terapias tradicionales.

Característica del tratamiento	Enfoque inmutep	Enfoque tradicional
Efecto secundario Profile	Potencialmente reducido	Más agresivo
Interacción del sistema inmune	Modulación dirigida	Supresión no específica

IMMUTEP LIMITED (IMMP) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

ImmuTep Limited mantiene interacciones directas con investigadores médicos a través de canales de comunicación específicos:

Método de compromiso	Frecuencia	Público objetivo
Simposios de investigación	Trimestral	Investigadores de oncología
Reuniones de la junta asesora científica	By-anualmente	Líderes de opinión clave
Plataformas de investigación digital	Continuo	Red de investigación global

Asociaciones colaborativas con especialistas en oncología

Las asociaciones colaborativas actuales incluyen:

• Merck KGAA Colaboración para el programa LAG-3
• Asociaciones de ensayos clínicos patrocinados por NIH
• Acuerdos de investigación del Centro Médico Académico

Presentaciones científicas regulares y participación de la conferencia

Tipo de conferencia	Presentaciones anuales	Alcance de la audiencia
Reunión anual de ASCO	3-4 presentaciones	Más de 8,000 profesionales de oncología
Congreso de ESMO	2-3 presentaciones	6,500+ investigadores internacionales

Comunicación transparente del progreso del ensayo clínico

Canales de comunicación para la transparencia del ensayo clínico:

• Actualizaciones trimestrales de inversores e investigaciones
• Actualizaciones de registro de ensayos clínicos en tiempo real
• Envíos de publicación revisados ​​por pares

Enfoque de desarrollo terapéutico centrado en el paciente

Estrategia de participación del paciente	Método de implementación	Métrica de impacto
Juntas de asesoramiento de pacientes	Reuniones virtuales trimestrales	15 representantes de pacientes
Soporte de reclutamiento de ensayos clínicos	Equipo de enlace de paciente dedicado	Tasas de inscripción mejoradas

IMMUTEP LIMITED (IMMP) - Modelo de negocio: canales

Conferencias científicas y simposios médicos

Immutep Limited participa en conferencias clave de inmunoterapia, que incluyen:

Reunión anual de ASCO	2023 Participación	Presentaciones de carteles: 3
Sociedad Europea de Oncología Médica (ESMO)	2023 compromiso	Resúmenes de investigación: 2
Asociación Americana para la Investigación del Cáncer (AACR)	2023 Presencia	Presentaciones de plataforma: 1

Publicaciones médicas revisadas por pares

Métricas de publicación para ImmuteP en 2023:

• Publicaciones totales revisadas por pares: 7
• Citas acumulativas: 42
• Rango de factor de impacto: 4.5 - 12.3

Alcance de la industria farmacéutica directa

Detalles de asociación de la industria y colaboración:

Asociaciones farmacéuticas activas	3
Colaboraciones de ensayos clínicos en curso	5
Valor de asociación total	$ 18.5 millones

Comunicaciones de relaciones con los inversores

Métricas de compromiso de los inversores:

• Llamadas de ganancias trimestrales: 4
• Presentaciones de inversores: 6
• Asistentes anuales de la reunión de accionistas: 127

Plataformas digitales y redes científicas

Canales de comunicación digital:

Seguidores de LinkedIn	4,523
Seguidores de Twitter	2,187
Sitio web Visitantes mensuales	12,456

Immutep Limited (IMMP) - Modelo de negocio: segmentos de clientes

Instituciones de investigación de oncología

A partir de 2024, ImmuTep Limited se dirige aproximadamente 387 instituciones de investigación de oncología global con un interés potencial en las inmunoterapias dirigidas por retraso 3.

Región	Número de instituciones	Enfoque de investigación
América del norte	156	Inmunoterapias avanzadas de cáncer
Europa	127	Investigación de oncología de precisión
Asia-Pacífico	104	Desarrollo inmuno-oncológico

Compañías farmacéuticas

Immutep se involucra con 62 compañías farmacéuticas centradas en la terapéutica del cáncer.

• Las 10 principales compañías farmacéuticas globales evalúan activamente las tecnologías LAG-3
• Valor de asociación potencial estimado en $ 127.5 millones
• Acuerdos de investigación colaborativos en etapas avanzadas

Investigadores clínicos

Población objetivo de 2.341 investigadores clínicos especializados a nivel mundial.

Especialización	Número de investigadores
Inmuno-oncología	876
Inmunoterapia con cáncer	642
Investigación traslacional	823

Inversores de biotecnología

Se dirige a aproximadamente 215 firmas de inversión centradas en la biotecnología con posibles intereses en las tecnologías de inmuno-oncología.

• Empresas de capital de riesgo: 87
• Inversores de capital privado: 62
• Inversores institucionales: 66

Pacientes con indicaciones de cáncer dirigidas

Análisis del segmento de pacientes para posibles intervenciones terapéuticas LAG-3.

Tipo de cáncer	Población de pacientes estimada	Posibles candidatos de tratamiento
Melanoma metastásico	68,000 pacientes	24,500
Cáncer de pulmón de células no pequeñas	228,000 pacientes	82,000
Cáncer de cabeza y cuello	66,000 pacientes	19,800

IMMUTEP LIMITED (IMMP) - Modelo de negocio: estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, ImmuteP Limited informó gastos de investigación y desarrollo de AUD 12.3 millones.

Categoría de gastos	Cantidad (AUD)
Desarrollo del programa LAG-3	7.5 millones
Investigación de ensayos clínicos	4.2 millones
Estudios preclínicos	0.6 millones

Costos de gestión de ensayos clínicos

Los costos de gestión de ensayos clínicos para ImmuteP en 2023 totalizaron aproximadamente AUD 8.7 millones.

• Costos de prueba de Fase II Tacti-002: AUD 3.5 millones
• Costos de prueba de Fase III Insight: AUD 4.2 millones
• Gastos de reclutamiento y monitoreo de pacientes: AUD 1 millón

Protección de propiedad intelectual

Immutep asignó AUD 1.2 millones para la protección de la propiedad intelectual en 2023.

Categoría de protección de IP	Gasto (AUD)
Presentación de patentes	0.7 millones
Consulta legal	0.3 millones
Registro de marcas registradas	0.2 millones

Personal y reclutamiento de talento científico

Los gastos de personal para ImmuteP en 2023 fueron AUD 6.5 millones.

• Salarios del personal científico: AUD 4.8 millones
• Compensación ejecutiva: AUD 1.2 millones
• Reclutamiento y capacitación: AUD 0.5 millones

Infraestructura tecnológica y mantenimiento de laboratorio

Los costos de tecnología y mantenimiento de laboratorio para 2023 ascendieron a AUD 3.2 millones.

Categoría de infraestructura	Gasto (AUD)
Equipo de laboratorio	1.8 millones
Infraestructura	0.9 millones
Mantenimiento y actualizaciones	0.5 millones

IMMUTEP LIMITED (IMMP) - Modelo de negocio: flujos de ingresos

Posibles acuerdos de licencia

A partir de 2024, ImmuteP Limited tiene posibles acuerdos de licencia para su tecnología de plataforma LAG-3. La compañía tiene discusiones continuas con posibles socios farmacéuticos.

Pareja	Tecnología	Alcance de ingresos potenciales
Merck KGAA	Eftilagimod alfa (programa LAG-3)	Hasta $ 1.3 mil millones en posibles pagos de hitos

Subvenciones de investigación y financiación del gobierno

Immutep ha obtenido fondos de investigación de varias fuentes.

Fuente de financiación	Cantidad	Año
Cancer Australia	AUD $ 398,000	2023

Ingresos futuros de asociación farmacéutica

La compañía está explorando múltiples oportunidades de asociación farmacéutica.

• Asociación potencial con compañías globales de oncología
• Discusiones de colaboración continuas en el sector de inmuno-oncología

Pagos potenciales de hitos de desarrollos clínicos

ImmuteP ha estructurado posibles acuerdos de pago de hitos.

Programa clínico	Pagos potenciales de hitos	Condición
Tacti-003 de prueba	Hasta $ 560 millones	Cáncer de mama metastásico

Comercialización de productos terapéuticos a largo plazo

Potencial de ingresos del desarrollo de productos terapéuticos.

• Potencial de comercialización alfa de Eftilagimod en múltiples indicaciones de cáncer
• Oportunidad de mercado global estimada en inmuno-oncología: $ 150 mil millones para 2025

Immutep Limited (IMMP) - Canvas Business Model: Value Propositions

You're looking at the core value Immutep Limited (IMMP) brings to the table, which is rooted in its unique approach to immune activation and its pipeline progress as of late 2025. It's not just about blocking checkpoints; it's about turning the immune system on in a specific way.

Immune System Activation: Efti is a unique APC activator, not just a checkpoint blocker.

The lead candidate, eftilagimod alfa (efti), acts as a soluble LAG-3 protein and MHC Class II agonist, which stimulates both innate and adaptive immunity. This is a different mechanism than a pure checkpoint blocker. The value proposition here is demonstrated by the breadth of efficacy seen across trials. For instance, in the investigator-initiated INSIGHT-003 trial for non-squamous 1L NSCLC, the combination including efti achieved a high 60.8% Objective Response Rate (ORR) and 90.2% Disease Control Rate (DCR) (N=51) as of the May 6, 2025, data cut-off.

The autoimmune pipeline, IMP761, which is a first-in-class LAG-3 agonist antibody, also supports this activation/modulation theme. Initial data from its Phase I study showed a substantial reduction in T cell activity. Specifically, at the 0.9 mg/kg dose level, the inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge reached 80%.

Improved Outcomes in Cold Tumors: Potential to boost response rates in PD-L1 negative/low cancers (e.g., HNSCC CPS <1).

A significant value driver is efti's ability to improve outcomes where standard PD-1 inhibitors are less effective. You see this clearly in the data from the TACTI-003 Phase IIb trial for 1L Head and Neck Squamous Cell Carcinoma (HNSCC) patients with PD-L1 expression below one (CPS <1). For these patients, who typically don't respond well to anti-PD-1 therapy alone, the chemotherapy-free combination with efti and KEYTRUDA achieved a median Overall Survival (OS) of 17.6 months in evaluable patients (N=31, data cut-off March 31, 2025).

Similarly, in the INSIGHT-003 trial for NSCLC, the combination showed strong performance in the high unmet need group with PD-L1 expression below 50% (TPS <50%), representing over two-thirds of the 1L NSCLC population. This group achieved a 61.7% ORR compared to a historical control of 40.8%.

Chemotherapy-Sparing Regimens: Offering effective combination therapy without chemotherapy in certain settings.

The TACTI-003 trial in 1L HNSCC with CPS <1 specifically evaluates efti in combination with KEYTRUDA without chemotherapy. The positive survival data here-a median OS of 17.6 months-demonstrates efficacy without the added toxicity of chemotherapy in this specific patient segment. The complete response rate in this cohort reached 16.1% by iRECIST.

Broad Market Potential: Targeting the entire 1L NSCLC patient population regardless of PD-L1 expression.

The pivotal TACTI-004 Phase III trial is designed to capture the entire first-line metastatic NSCLC market by enrolling approximately 756 patients regardless of PD-L1 expression (Tumour Proportion Score or TPS of 0-100%). This broad indication is supported by the INSIGHT-003 data showing strong response rates across all PD-L1 levels. The company had 31 Employees as of its latest reports.

Autoimmune Disease Pipeline: IMP761 addresses a defintely high unmet need in autoimmune disorders.

IMP761 is positioned to target large and growing disorders like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis, which are all described as multi-billion dollar markets. The Phase I trial is progressing through ascending dose levels of 2.5, 7, and 14 mg/kg after observing promising data at 0.9 mg/kg. The company reported FY2025 revenue of A$5.04 million, up 31.28% year-over-year, against losses of -A$61.43 million. The cash position as of June 30, 2025, was A$129.69 million, providing an expected cash reach to the end of CY2026.

Here's a quick look at the key efficacy and pipeline data points:

Trial/Candidate	Metric	Value	Patient Group/Context
INSIGHT-003 (efti + KTR + Chemo)	Objective Response Rate (ORR)	60.8%	All PD-L1 levels (N=51)
INSIGHT-003 (efti + KTR + Chemo)	ORR	61.7%	TPS <50% (N=47)
TACTI-003 Cohort B (efti + KTR)	Median Overall Survival (OS)	17.6 months	1L HNSCC, CPS <1 (N=31)
IMP761 Phase I	T cell Infiltration Inhibition	80%	Day 10 post-rechallenge at 0.9 mg/kg
TACTI-004 Phase III	Planned Enrollment	Approx. 756 patients	1L NSCLC, global study

The value proposition is further supported by corporate financial stability and recent funding:

• FY2025 Revenue: A$5.04 million
• FY2025 Losses: -A$61.43 million
• Cash Position (as of June 30, 2025): A$129.69 million
• French R&D Tax Incentive Received: A$4.6 million

The company is advancing IMP761 through dose levels of 2.5, 7, and 14 mg/kg in its Phase I study.

Finance: review the burn rate implied by the A$61.43 million FY2025 loss against the A$129.69 million cash on hand.

Immutep Limited (IMMP) - Canvas Business Model: Customer Relationships

Strategic Partner Management: High-touch, dedicated relationship management with Big Pharma partners (e.g., MSD).

The relationship with MSD is structured around Immutep Limited supplying eftilagimod alfa (efti) while MSD supplies KEYTRUDA, as part of Immutep Limited's third collaboration with MSD. This partnership underpins the pivotal TACTI-004 Phase III trial. Additionally, the TACTI-003 Phase IIb trial is conducted in collaboration with MSD.

Partner	Program(s) Involved	MSD Contribution	Immutep Limited Retention
MSD (Merck & Co., Inc.)	TACTI-004 (Phase III)	Supply of KEYTRUDA	Commercial rights to efti
MSD (Merck & Co., Inc.)	TACTI-003 (Phase IIb)	Supply of KEYTRUDA	Not explicitly stated for TACTI-003, but generally retains rights

Clinical Investigator Support: Direct engagement with Key Opinion Leaders (KOLs) at over 150 global trial sites.

The TACTI-004 global Phase III trial is set to randomize approximately 756 patients across more than 100 activated clinical sites in 24 countries as of the Quarter 1 Fiscal Year 2026 report. The trial design anticipates utilizing more than 150 clinical sites in over 25 countries in total. The TACTI-003 trial involves up to 35 clinical sites across Australia, Europe, and the US. The INSIGHT-003 trial completed enrolment of approximately 50 evaluable patients across multiple clinical sites in Germany.

• TACTI-004 (Phase III NSCLC): Over 100 sites open, 24 countries approved (as of Oct 2025).
• TACTI-004 (Target): Randomize approximately 756 patients at more than 150 sites.
• TACTI-003 (Phase IIb HNSCC): Up to 35 clinical sites.
• INSIGHT-003 (Phase I NSCLC): Enrolment completed across multiple sites in Germany.

Investor Relations: Proactive communication of clinical milestones and financial health to shareholders.

As of the latest reported figures, Immutep Limited's Market Capitalization stood at approximately A$390.1M in November 2025. The cash and term deposits balance was reported at A$109.85M in the Q1 FY26 report (October 2025), providing an expected cash reach to the end of CY2026. Analyst sentiment indicated a target price of $4.52 per share. The Vice President, Investor Relations and Corporate Communications, can be reached at +1 (631) 318 4000. The company provided an Investor Update in April 2025 and another at the AGM in November 2025.

• Latest Market Cap: A$390.1M (November 2025).
• Cash & Term Deposits (Q1 FY26): A$109.85M.
• Cash Runway Estimate: Until end of CY2026.
• Analyst Target Price: $4.52.

Regulatory Body Engagement: Ongoing dialogue with agencies like the FDA for development guidance.

Immutep Limited announced the successful completion of FDA Project Optimus requirements on October 13, 2025. This resulted in agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti), which is a key building block for future Biological License Applications (BLA) filings. Eftilagimod alfa has received Fast Track designation from the FDA for first-line Head and Neck Squamous Cell Carcinoma (HNSCC) with CPS less than 1, and also for first-line Non-Small Cell Lung Cancer (NSCLC). The FDA provided constructive feedback on late-stage development paths for efti in 1L HNSCC, suggesting registrational or single-arm paths for an estimated 70-90 patients.

Regulatory Body	Key Interaction/Feedback	Date of Announcement	Impact/Outcome
FDA	Completion of Project Optimus Requirements	October 13, 2025	Agreement on 30mg optimal biological dose for efti.
FDA	Guidance for 1L HNSCC (CPS<1)	Late 2025 (based on August 2025 review)	Paths for registrational or single-arm study (≈70-90 patients).
FDA	Fast Track Designation	Prior to late 2025	Granted for efti in 1L HNSCC (CPS<1) and 1L NSCLC.

Immutep Limited (IMMP) - Canvas Business Model: Channels

You're looking at how Immutep Limited (IMMP) gets its drug development and potential commercial value out to the world. For a late-stage biotech, the channels aren't about selling widgets directly; they are about partnerships, data dissemination, and regulatory gatekeeping. Here's the breakdown of the mechanisms they use as of late 2025.

Out-Licensing Agreements: Primary channel for commercialization via global pharmaceutical partners

The commercialization channel relies heavily on securing agreements with larger pharmaceutical entities who have the infrastructure for global market access. While the primary focus is on in-house development of eftilagimod alfa (efti), past and potential future deals form a key part of the strategy.

• The development and commercialization rights for the candidate IMP731 reverted to Immutep Limited from GSK, effective May 30, 2024, after GSK terminated the agreement.
• Immutep may receive milestones plus royalties from EOC for rights in China.
• Under a 2020 License and Collaboration Agreement with LabCorp, Immutep may be eligible to receive further revenues from commercial milestones.
• The ongoing pivotal TACTI-004 trial is a collaboration with MSD, where MSD supplies KEYTRUDA; the typical drug supply for such a Phase III trial is approximately US$100 million.

Global Clinical Trial Network: The mechanism for drug development and data generation across 25+ countries

Drug development and data generation are channeled through a vast, multinational clinical trial network, essential for generating the evidence required for global regulatory submissions. The TACTI-004 Phase III trial is the current centerpiece of this channel.

Here's a snapshot of the scale of this development channel:

Trial/Program	Patient Enrollment Target	Clinical Sites	Countries	Key Milestone/Status (as of late 2025)
TACTI-004 (Phase III NSCLC)	Approximately 756 patients	Over 150 sites (78 sites approved as of July 2025)	Over 25 countries (23 countries approved as of July 2025)	First patient dosed in March 2025; Q1 futility analysis expected early 2026
TACTI-003 (Phase IIb HNSCC)	Approximately 154 patients	Up to 35 clinical sites	Australia, Europe, and US	Enrolment completed in November 2023
AIPAC-003 (Phase II Metastatic Breast Cancer)	Enrolled 71 patients (Phase II portion)	22 clinical sites	Europe and the United States	Patient follow up ongoing; update anticipated in CY2025

The Company maintained a strong cash position to fund these activities, reporting a cash and cash equivalent, and term deposit balance as at June 30, 2025, of approximately A$129.69 million.

Scientific and Medical Conferences: Presenting data at ESMO, ELCC, and WCLC to influence prescribing physicians

Presenting data at major medical congresses is the direct channel to influence key opinion leaders and prescribing physicians, validating the science behind efti. You need to be seen where the peers are looking.

• Data for TACTI-004 was presented as a Trial in Progress poster at the IASLC 2025 World Conference on Lung Cancer (WCLC) in September 2025.
• Presentations regarding efti were made at ELCC in Paris and ASCO in Chicago in 2025.
• The ESMO Congress 2025 in October saw presentations for EFTISARC-NEO and TACTI-004.
• Data from the AIPAC-003 trial is scheduled for presentation at the 2025 San Antonio Breast Cancer Symposium in December 2025.
• The EFTISARC-NEO Phase II results were presented at the CTOS 2025 Annual Meeting in November 2025.

Regulatory Filings: Submitting data to the FDA, EMA, and other bodies for market approval

Regulatory submissions are the formal channel to gain market access. The US FDA is a critical focus for Immutep Limited.

• Immutep announced successful completion of FDA Project Optimus requirements on October 13, 2025.
• The Company has Fast Track designation from the FDA for eftilagimod alfa in first line Head and Neck Squamous Cell Carcinoma (HNSCC) and in first line Non-Small Cell Lung Cancer (NSCLC).
• FDA provided positive feedback on late-stage clinical development for eftilagimod alfa in HNSCC with CPS <1 on August 05, 2025.
• The TACTI-004 trial has received full clearances starting with Australia in December 2024, followed by 19 additional countries since.
• The Company has successfully completed regulatory submissions in the vast majority of the more than 25 countries planned for the TACTI-004 trial.

Immutep Limited (IMMP) - Canvas Business Model: Customer Segments

You're looking at the core groups Immutep Limited (IMMP) targets to drive value from its LAG-3 immunotherapy pipeline. It's not just about the patients; it's about the ecosystem that validates and commercializes the science. Here's the breakdown of who Immutep Limited is focused on as of late 2025.

Large Pharmaceutical Companies

These are the entities that provide the capital and global reach necessary to turn clinical assets into market-leading treatments. Immutep Limited currently has four assets in development, with two already out-licensed: LAG525 to Novartis and IMP731 to GSK.

The confidence from major financial players is also a key segment, as institutional backing can signal strategic stability to potential partners. Institutional ownership stands at 51% of outstanding shares. Key holders include BNY Asset Management with a 16% stake and Millennium Management holding 12%.

The potential for a major deal is high, especially for the in-house assets. For instance, the un-risked program valuation for IMP761 is estimated at A$5.9B, with a median valuation calculated at US$60M.

Oncology Key Opinion Leaders (KOLs)

KOLs and the institutions they represent are critical for running the large, complex trials that validate Immutep Limited's lead candidate, eftilagimod alpha (efti). These are the investigators who guide treatment protocols based on data readouts.

The pivotal TACTI-004 Phase III trial in first-line non-small cell lung cancer (1L NSCLC) is a massive undertaking, randomizing approximately 756 patients across more than 150 clinical sites and 23 countries that have received regulatory approval.

Other key investigator-initiated trials also rely on KOL engagement:

• The INSIGHT-003 trial in 1L NSCLC enrolled approximately 50 evaluable patients in Germany.
• The TACTI-003 Phase IIb trial in head and neck cancer (HNSCC) involves approximately 154 patients.
• The EFTISARC-NEO Phase II trial in soft tissue sarcoma reached its enrolment target of 40 patients in Poland.

Cancer Patients

The direct beneficiaries are patients with advanced cancers where current standards of care have limitations. Immutep Limited is actively targeting specific patient populations through ongoing and recently completed trials. You defintely see the focus across three major indications.

Here's a look at the patient cohorts central to the current oncology pipeline as of late 2025:

Indication	Trial/Cohort	Patient Count/Status	Key Clinical Data Point (as of late 2025)
Non-Small Cell Lung Cancer (NSCLC)	TACTI-004 (Phase III)	Approximately 756 patients to be randomized	INSIGHT-003 cohort showed 32.9-months median Overall Survival (OS).
Head and Neck Squamous Cell Carcinoma (HNSCC)	TACTI-003 (Phase IIb, CPS <1)	Approximately 154 patients planned	Median OS of 17.6-months in evaluable patients (N=31) with CPS <1 (data cut-off March 31, 2025).
Metastatic Breast Cancer (MBC)	AIPAC-003 (Phase II)	71 patients enrolled (exhausted endocrine therapy)	New data from this trial is slated for presentation at the 2025 San Antonio Breast Cancer Symposium.

Autoimmune Disease Specialists

This segment represents a significant future opportunity, primarily driven by the IMP761 program, a first-in-class LAG-3 agonist antibody. Specialists in conditions like rheumatoid arthritis, Type 1 diabetes, and multiple sclerosis are the eventual prescribers.

The Phase I study for IMP761 is progressing, with pharmacodynamic data from the 0.9 mg/kg dose level showing an 80% inhibition of T cell infiltration in the skin at day 10 following a neoantigen rechallenge. The company is continuing dose escalation to 2.5, 7, and 14 mg/kg.

The market potential is substantial; the targeted disorders are described as representing multi-billion dollar markets.

For context on the company's overall financial standing supporting these customer-facing activities, Immutep Limited reported FY2025 revenue of A$5.04 million (a 31.28% increase year-over-year) against a loss of -A$61.43 million. The cash position at June 30, 2025, was A$129.7 million, which provides an expected cash reach into the end of CY2026.

Immutep Limited (IMMP) - Canvas Business Model: Cost Structure

As a pre-revenue, clinical-stage biotech, the Cost Structure for Immutep Limited is heavily weighted toward advancing its pipeline, particularly the lead candidate, eftilagimod alfa (efti). You're looking at a model where cash burn is directly proportional to clinical progress, so every dollar spent is an investment in future potential.

Research and Development (R&D) Costs: Dominant cost, driven by clinical trial execution (Phase III TACTI-004).

Research and Development and Intellectual Property expenses represent the single largest cost component, reflecting the capital-intensive nature of late-stage oncology development. For the fiscal year ended June 30, 2025 (FY2025), these combined expenses reached A$61.41 million. This was a significant increase from A$41.55 million in FY2024, driven primarily by the planned escalation in clinical trial activity, most notably the commencement of the pivotal Phase III TACTI-004 trial in first-line Non-Small Cell Lung Cancer (NSCLC) in collaboration with MSD. Honestly, this is where the bulk of the operating cash is going.

The major cost drivers within this category include:

• Costs associated with the Phase III TACTI-004 trial execution.
• Expenditure on the ongoing patient follow-up and data analysis for the AIPAC-003 trial.
• Contract laboratory services and associated staff costs.

Net Operating Cashflow (FY2025): -A$62 million reflecting high trial expenditure.

The high R&D spend translates directly into negative operating cashflow, which is standard for a company in this development stage. For FY2025, Immutep Limited reported a Net Operating Cashflow of -A$62.05 million. This figure shows the rate at which the company was consuming cash to fund its development pipeline through the year.

Intellectual Property and Patent Maintenance Costs: Global costs to protect the LAG-3 portfolio.

Costs for maintaining the global intellectual property estate are bundled with R&D, but the protection of the core LAG-3 assets is a critical, non-negotiable expense. This cost base supports the exclusivity of efti and the next-generation candidate, IMP761. To be fair, the investment in IP is showing returns in terms of asset building.

Here are some key IP milestones from FY2025:

Metric	FY2025 Data (A$)	Detail
New Patents Granted	17	New patents granted across key territories for efti and IMP761.
IP Component of R&D/IP Expense	Included in A$61.41 million	Combined with R&D, reflecting global filing and maintenance fees.

General and Administrative (G&A) Expenses: Corporate overhead and public company compliance costs.

Corporate overhead, reported as Corporate Administrative Expenses, is managed with a focus on efficiency, especially given the high R&D burn rate. For FY2025, these expenses were A$8.64 million. This was a slight reduction from A$8.85 million in FY2024, which aligns with the reported decrease of approximately A$208k in overhead costs, showing defintely a disciplined approach to non-research spending.

G&A costs cover the necessary functions to operate as a dual-listed public entity:

• Board and Senior Management remuneration.
• Audit, legal, and regulatory compliance for both ASX and NASDAQ listings.
• General office and administrative overhead.

Net Loss (FY2025): -AUD 61.43 million as a pre-revenue biotech.

As expected for a company focused entirely on clinical development without product sales, the bottom line reflects the total operating expenditure less minimal other income (which was A$10.33 million in FY2025). The Net Loss after tax for FY2025 was -A$61.43 million. This compares to a loss of A$42.7 million in the prior year, directly tracking the planned increase in R&D investment to push TACTI-004 forward. That's the cost of chasing a potential blockbuster therapy.

Immutep Limited (IMMP) - Canvas Business Model: Revenue Streams

You're looking at the core ways Immutep Limited brings in cash to fund its clinical pipeline, so let's break down the actual numbers we see for the fiscal year ending June 30, 2025.

The total revenue picture for Immutep Limited shows growth from non-core activities, primarily driven by investment returns and government support, as product sales revenue remains zero at this clinical stage. For Fiscal Year 2025, the Total Revenue and Other Income reached AUD 10.33 million. That's a solid step up from the AUD 7.84 million reported in FY2024.

Here's a quick look at the key financial components contributing to that top line:

Revenue Component	FY2025 Amount (AUD)	FY2024 Amount (AUD)
Total Revenue and Other Income	10,330,000	7,840,000
Interest Income	5.29 million	3.88 million

The increase in interest income to A$5.29 million in FY2025, up from A$3.88 million the year prior, shows Immutep Limited is getting better returns by prudently investing surplus cash balances in term deposits. That's smart cash management when you're not yet selling a drug.

Licensing and Milestone Payments

This stream relies on non-dilutive payments from the company's established partners. Immutep Limited has agreements in place with major players like Novartis, which is funding the development of its IMP701 (LAG525) antibody program. Also, EOC Pharma holds the exclusive development rights for efti in Greater China. These deals are structured to provide upfront fees, future milestone payments upon achieving clinical or regulatory success, and ultimately, royalties on product sales. While specific milestone payments received in FY2025 from these partners aren't explicitly detailed as a separate line item from the total revenue, the structure is definitely a key part of the model.

Research Grants and Tax Incentives

This is a concrete, recent cash inflow. Immutep Limited announced it received the A$4.6 million French R&D Tax Incentive on October 29, 2025. This type of non-dilutive funding is crucial for supporting research and development activities, particularly through its French subsidiary. The company recognizes grant income, with A$2.02 million recognized in the prior half-year attributed to the French subsidiary.

The revenue streams can be summarized by their nature:

• Partner Payments: Milestone payments and royalties from Novartis and EOC Pharma agreements.
• Government Support: Research grants and tax incentives, such as the A$4.6 million French R&D Tax Incentive received in late 2025.
• Financial Income: Interest income from cash holdings, which totaled A$5.29 million in FY2025.

Future Royalties on Product Sales

The major long-term value driver is future royalties. Immutep Limited retains the global development rights for efti outside of Greater China, giving it the option to out-license further territories. Royalties are the expected stream once out-licensed products, like efti through EOC Pharma in China, gain approval and generate sales. These are contingent, but represent the largest potential future cash flow.

Potential Future Product Sales

This stream is currently theoretical but remains an option. Immutep Limited holds the rights to efti in territories not yet out-licensed. Should the company decide to commercialize efti directly in any of those territories, it would establish a direct product sales revenue stream, bypassing the royalty structure for those specific markets. Finance: draft 13-week cash view by Friday.