Immutep Limited (IMMP): modelo de negócios [Jan-2025 Atualizado]

No cenário dinâmico da imunoterapia contra o câncer, a Immutep Limited (IMMP) surge como uma empresa pioneira em biotecnologia que revoluciona os paradigmas de tratamento por meio de sua inovadora tecnologia de direcionamento de LAG-3. Ao alavancar pesquisas científicas inovadoras e parcerias estratégicas, a Immutep está pronta para transformar a maneira como abordamos o tratamento do câncer, oferecendo possíveis terapias inovadoras que prometem intervenções mais precisas e direcionadas com efeitos colaterais reduzidos. Seu modelo de negócios exclusivo combina experiência científica de ponta, redes de pesquisa colaborativa e uma abordagem de desenvolvimento focada no paciente, posicionando a empresa na vanguarda de intervenções imunológicas de próxima geração.

Immutep Limited (IMMP) - Modelo de Negócios: Principais Parcerias

Colaborações de instituições de pesquisa acadêmica

A Immutep Limited estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco na pesquisa	Status de colaboração
Universidade de Southampton	Estudos de imunoterapia	Parceria ativa
Peter MacCallum Cancer Center	Pesquisa relacionada ao LAG-3	Pesquisa clínica em andamento

Parcerias da empresa farmacêutica

A Immutep possui colaborações estratégicas com empresas farmacêuticas:

• Merck KGAA - Faça uma parceria para o Eftilagimod Alpha (EFTI) Development
• GSK - Colaboração em pesquisa de imuno -oncologia

Organizações de pesquisa contratada (CROs)

Nome do CRO	Suporte ao ensaio clínico	Projetos atuais
Icon plc	Gerenciamento de estudo de fase II/III	Insight Clinical Trial
Parexel International	Projeto de ensaios clínicos	Estudos metastáticos de câncer de mama

Pesquisa agências de financiamento

Apoio de financiamento de agências de pesquisa governamental e privada:

• Conselho Nacional de Saúde e Pesquisa Médica (NHMRC) - Forneceu 750.000 AUD em subsídios de pesquisa
• Cancer Research UK - Iniciativas de pesquisa de imunoterapia apoiadas

Immutep Limited (IMMP) - Modelo de negócios: Atividades -chave

Desenvolvimento de novos tratamentos de imunoterapia direcionados à proteína LAG-3

A Immutep Limited se concentra no desenvolvimento de imunoterapias inovadoras relacionadas ao LAG-3. A partir de 2024, a empresa possui:

Tipo de terapia	Estágio de desenvolvimento	Indicação alvo
Eftilagimod alfa (IMP321)	Ensaios clínicos de fase 3	Câncer de mama metastático
Anticorpos antagonistas do LAG-3	Desenvolvimento pré -clínico	Vários tipos de câncer

Conduzindo ensaios pré -clínicos e clínicos para imunoterapias de câncer

Despesas de ensaios clínicos para 2023 ano fiscal: AU $ 18,4 milhões

• Ensaios clínicos ativos em múltiplas indicações de câncer
• Colaboração com instituições de pesquisa internacionais
• Estudos clínicos de fase 2 e fase em andamento

Pesquisa e desenvolvimento de anticorpos terapêuticos

Métrica de P&D	2023 valor
Despesas totais de P&D	AU $ 22,7 milhões
Pessoal de P&D	36 pesquisadores especializados

Desenvolvimento de patentes e gestão de propriedade intelectual

Portfólio de patentes a partir de 2024:

• 18 patentes concedidas em todo o mundo
• 12 pedidos de patente pendente
• Propriedade intelectual que cobre plataformas de tecnologia LAG-3

Desenvolvimento estratégico de negócios e negociações de licenciamento

Parceria	Status	Valor potencial
Colaboração Merck KGAA	Ativo	Até 93 milhões de euros em possíveis pagamentos marcantes
Contrato de licenciamento da Novartis	Discussões em andamento	Termos financeiros não divulgados

Immutep Limited (IMMP) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia LAG-3 proprietária

A plataforma de tecnologia principal da Immutep focada na tecnologia do ponto de verificação imune LAG-3. A partir de 2024, a empresa desenvolveu vários candidatos terapêuticos em estágio clínico direcionados à via LAG-3.

Ativo de tecnologia	Estágio de desenvolvimento	Aplicações em potencial
Eftilagimod alfa (IMP321)	Ensaios clínicos de fase 3	Câncer de mama metastático
Imp761	Ensaios clínicos de fase 1	Doenças autoimunes

Equipe de Pesquisa e Desenvolvimento Científica

A Immutep mantém uma equipe de pesquisa especializada com experiência em imunoterapia e tecnologia LAG-3.

• Pessoal total de P&D: aproximadamente 35-40 funcionários científicos
• Pesquisadores no nível de doutorado: aproximadamente 20 a 25 membros da equipe
• Locais de pesquisa global: Austrália e França

Portfólio de propriedade intelectual

Proteção robusta de patente para plataforma de tecnologia LAG-3.

Categoria de patentes	Número de patentes ativas	Cobertura geográfica
Tecnologia LAG-3	15-20 famílias de patentes	Estados Unidos, Europa, Austrália

Dados de ensaios clínicos e recursos de pesquisa

Extensa experiência em ensaios clínicos em múltiplas indicações oncológicas.

• Ensaios clínicos ativos: 4-5 estudos simultâneos
• Inscrição cumulativa de pacientes: mais de 300 pacientes
• Fases de teste: Fase 1, Fase 2 e Fase 3

Experiência especializada em imunoterapia

Parcerias e colaborações estratégicas aprimoram as capacidades tecnológicas.

Parceiro de colaboração	Área de foco	Status da parceria
Merck kgaa	Pesquisa de imunoterapia	Aliança estratégica em andamento
GSK	Desenvolvimento Clínico	Acordo de Pesquisa Colaborativa

Immutep Limited (IMMP) - Modelo de Negócios: Proposições de Valor

Immoterapia inovadora para câncer direcionando a proteína LAG-3

A Immutep Limited se concentra no desenvolvimento de eftilagimod alfa (EFTI), uma nova imunoterapia com câncer de direcionamento da proteína LAG-3 direcionada. A partir de 2023, o candidato a produtos principais da empresa demonstrou potencial em vários ensaios clínicos.

Produto	Estágio de desenvolvimento	Indicação alvo
Eftilagimod alfa (efti)	Ensaios clínicos de fase 3	Câncer de mama metastático
Eftilagimod alfa (efti)	Ensaios clínicos de fase 2	Câncer de pulmão de células não pequenas

Possíveis tratamentos inovadores para vários tipos de câncer

A abordagem terapêutica da Immutep tem como alvo vários tipos de câncer através da modulação da proteína LAG-3.

• Câncer de mama metastático
• Câncer de pulmão de células não pequenas
• Carcinoma de células escamosas de cabeça e pescoço
• Câncer de ovário

Abordagem de medicina de precisão para tratamento de câncer

A estratégia de medicina de precisão da empresa se concentra em intervenções imunológicas direcionadas com mecanismos moleculares específicos.

Medicina de precisão Característica	Abordagem imutep
Direcionamento molecular	Modulação da proteína LAG-3
Tratamento personalizado	Personalização da imunoterapia

Melhores resultados dos pacientes através de intervenções imunológicas direcionadas

Os dados clínicos da Immutep demonstram melhorias potenciais na sobrevida dos pacientes e nas taxas de resposta ao tratamento.

• Ativação do sistema imunológico aprimorado
• Progressão tumoral reduzida
• Potencial sobrevida mais longa do paciente

Novas soluções terapêuticas com efeitos colaterais reduzidos

O eftilagimod alfa representa uma abordagem potencialmente menos invasiva de tratamento de câncer em comparação com as terapias tradicionais.

Característica do tratamento	Abordagem imutep	Abordagem tradicional
Efeito colateral Profile	Potencialmente reduzido	Mais agressivo
Interação do sistema imunológico	Modulação direcionada	Supressão não específica

Immutep Limited (IMMP) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com a comunidade de pesquisa médica

A Immutep Limited mantém interações diretas com pesquisadores médicos por meio de canais de comunicação direcionados:

Método de engajamento	Freqüência	Público -alvo
Simpósios de pesquisa	Trimestral	Pesquisadores de oncologia
Reuniões do Conselho Consultivo Científico	Bi-semestralmente	Líderes de opinião -chave
Plataformas de pesquisa digital	Contínuo	Rede de Pesquisa Global

Parcerias colaborativas com especialistas em oncologia

As parcerias colaborativas atuais incluem:

• Merck KGAA Collaboration for LAG-3 Program
• Parcerias de ensaios clínicos patrocinados pelo NIH
• Acordos de pesquisa do Centro Médico Acadêmico

Apresentações científicas regulares e participação da conferência

Tipo de conferência	Apresentações anuais	Alcance do público
Reunião Anual da ASCO	3-4 apresentações	Mais de 8.000 profissionais de oncologia
Congresso Esmo	2-3 apresentações	6.500 mais de pesquisadores internacionais

Comunicação transparente do progresso do ensaio clínico

Canais de comunicação para transparência de ensaios clínicos:

• Atualizações trimestrais de investidores e pesquisas
• Atualizações de registro de ensaios clínicos em tempo real
• Envios de publicação revisados ​​por pares

Abordagem de desenvolvimento terapêutico focado no paciente

Estratégia de envolvimento do paciente	Método de implementação	Métrica de impacto
Conselhos de consultoria de pacientes	Reuniões virtuais trimestrais	15 representantes de pacientes
Suporte de recrutamento de ensaios clínicos	Equipe dedicada de ligação paciente	Taxas de inscrição aprimoradas

Immutep Limited (IMMP) - Modelo de Negócios: Canais

Conferências científicas e simpósios médicos

A Immutep Limited participa de conferências importantes de imunoterapia, incluindo:

Reunião Anual da ASCO	2023 Participação	Apresentações de pôsteres: 3
Sociedade Europeia de Oncologia Médica (ESMO)	2023 Engajamento	Resumo da pesquisa: 2
Associação Americana de Pesquisa do Câncer (AACR)	2023 presença	Apresentações da plataforma: 1

Publicações médicas revisadas por pares

Métricas de publicação para imutep em 2023:

• Total de publicações revisadas por pares: 7
• Citações cumulativas: 42
• Faixa do fator de impacto: 4,5 - 12.3

Extenção direta na indústria farmacêutica

Detalhes da parceria e colaboração do setor:

Parcerias farmacêuticas ativas	3
Colaborações em andamento em andamento	5
Valor total da parceria	US $ 18,5 milhões

Comunicações de Relações com Investidores

Métricas de engajamento do investidor:

• Chamadas de ganhos trimestrais: 4
• Apresentações de investidores: 6
• Participantes da Reunião de Acionistas Anuais: 127

Plataformas digitais e redes científicas

Canais de comunicação digital:

Seguidores do LinkedIn	4,523
Seguidores do Twitter	2,187
Visitantes mensais do site	12,456

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

Instituições de Pesquisa Oncológica

Em 2024, a Immutep limitou alvos aproximadamente 387 instituições globais de pesquisa de oncologia, com potencial interesse em imunoterapias direcionadas ao LAG-3.

Região	Número de instituições	Foco na pesquisa
América do Norte	156	Imunoterapias avançadas do câncer
Europa	127	Pesquisa de oncologia de precisão
Ásia-Pacífico	104	Desenvolvimento de Imuno-Oncologia

Empresas farmacêuticas

A Immutep se envolve com 62 empresas farmacêuticas com foco na terapêutica do câncer.

• As 10 principais empresas farmacêuticas globais avaliando ativamente as tecnologias LAG-3
• Valor potencial de parceria estimado em US $ 127,5 milhões
• Acordos de pesquisa colaborativa em estágios avançados

Pesquisadores clínicos

População -alvo de 2.341 pesquisadores clínicos especializados em todo o mundo.

Especialização	Número de pesquisadores
Imuno-oncologia	876
Imunoterapia contra o câncer	642
Pesquisa translacional	823

Investidores de biotecnologia

Visando aproximadamente 215 empresas de investimento focadas em biotecnologia, com potencial interesse em tecnologias de imuno-oncologia.

• Empresas de capital de risco: 87
• Investidores de private equity: 62
• Investidores institucionais: 66

Pacientes com indicações direcionadas de câncer

Análise do segmento de pacientes para possíveis intervenções terapêuticas LAG-3.

Tipo de câncer	População estimada de pacientes	Candidatos a tratamento em potencial
Melanoma metastático	68.000 pacientes	24,500
Câncer de pulmão de células não pequenas	228.000 pacientes	82,000
Câncer de cabeça e pescoço	66.000 pacientes	19,800

Immutep Limited (IMMP) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Immutep Limited relatou as despesas de pesquisa e desenvolvimento da AUD 12,3 milhões.

Categoria de despesa	Valor (aud)
Desenvolvimento do Programa LAG-3	7,5 milhões
Pesquisa em ensaios clínicos	4,2 milhões
Estudos pré -clínicos	0,6 milhão

Custos de gerenciamento de ensaios clínicos

Os custos de gerenciamento de ensaios clínicos para Immutep em 2023 totalizaram aproximadamente 8,7 milhões.

• FASE II TATIO
• Fase III Insight Trial Custos: AUD 4,2 milhões
• Despesas de recrutamento e monitoramento de pacientes: AUD 1 milhão

Proteção à propriedade intelectual

IMUTEP Alocado AUD 1,2 milhão para proteção de propriedade intelectual em 2023.

Categoria de proteção IP	Despesas (AUD)
Registro de patentes	0,7 milhão
Consulta legal	0,3 milhão
Registro de marcas comerciais	0,2 milhão

Pessoal e recrutamento de talentos científicos

As despesas de pessoal para imutep em 2023 foram de 6,5 milhões de AUD.

• Salários da equipe científica: AUD 4,8 milhões
• Compensação de executivos: AUD 1,2 milhão
• Recrutamento e treinamento: AUD 0,5 milhão

Infraestrutura tecnológica e manutenção laboratorial

Os custos de tecnologia e manutenção de laboratório para 2023 totalizaram AUD 3,2 milhões.

Categoria de infraestrutura	Despesas (AUD)
Equipamento de laboratório	1,8 milhão
Infraestrutura de TI	0,9 milhão
Manutenção e atualizações	0,5 milhão

Immutep Limited (IMMP) - Modelo de negócios: fluxos de receita

Acordos de licenciamento em potencial

A partir de 2024, a Immutep Limited possui acordos de licenciamento em potencial para sua tecnologia de plataforma LAG-3. A empresa tem discussões em andamento com possíveis parceiros farmacêuticos.

Parceiro	Tecnologia	Escopo de receita potencial
Merck kgaa	Eftilagimod alfa (programa LAG-3)	Até US $ 1,3 bilhão em possíveis pagamentos de marcos

Bolsas de pesquisa e financiamento do governo

A Immutep garantiu financiamento de pesquisas de várias fontes.

Fonte de financiamento	Quantia	Ano
Cancer Australia	AUD $ 398.000	2023

Futuras receitas de parceria farmacêutica

A empresa está explorando várias oportunidades de parceria farmacêutica.

• Parceria potencial com empresas globais de oncologia
• Discussões de colaboração em andamento no setor de imuno-oncologia

Potenciais pagamentos marcantes de desenvolvimentos clínicos

A Immutep estruturou possíveis acordos de pagamento em marcos.

Programa Clínico	Potenciais pagamentos marcantes	Doença
TATI-003 TAUS	Até US $ 560 milhões	Câncer de mama metastático

Comercialização de produtos terapêuticos de longo prazo

Potencial de receita do desenvolvimento terapêutico do produto.

• Potencial de comercialização alfa eftilagimod em múltiplas indicações de câncer
• Oportunidade de mercado global estimada em imuno-oncologia: US $ 150 bilhões até 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.