Kazia Therapeutics Limited (KZIA): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da pesquisa de oncologia, a Kazia Therapeutics Limited (KZIA) surge como uma força pioneira, transformando a maneira como abordamos o tratamento do câncer por meio de estratégias inovadoras de desenvolvimento de medicamentos. Ao aproveitar um modelo de negócios sofisticado que preenche a pesquisa científica de ponta com parcerias estratégicas, a KZIA não é apenas mais uma empresa de biotecnologia, mas um potencial divulgador de jogo na segmentação de tipos complexos e raros de câncer. Sua abordagem única se concentra em terapias inovadoras para desafiar cânceres como glioblastoma, posicionando -os na vanguarda da medicina de precisão e oferecendo esperança onde os tratamentos tradicionais ficaram aquém.

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: Parcerias -chave

Colaboração de instituições de pesquisa acadêmica

A Kazia Therapeutics estabeleceu parcerias com as seguintes instituições de pesquisa acadêmica:

Instituição	Foco de colaboração	Ano estabelecido
Centro de Câncer Anderson da Universidade do Texas	Pesquisa de Paxalisib (GDC-0084)	2018
Escola de Medicina de Harvard	Desenvolvimento de medicamentos para oncologia	2020

Parcerias da empresa farmacêutica

As colaborações farmacêuticas atuais incluem:

• Genentech (subsidiária da Roche) para o apoio de ensaios clínicos de paxalisib
• Programa Nacional de Desenvolvimento de Medicamentos do Instituto de Câncer (NCI)

Interações do governo e da agência regulatória

Agência	Tipo de interação	Status
Administração de Alimentos e Medicamentos dos EUA (FDA)	Aplicação de novos medicamentos para investigação (IND)	Aprovado para paxalisib
Administração Australiana de Mercadorias Terapêuticas	Conformidade regulatória	Engajamento ativo

Investidores estratégicos em pesquisa de oncologia

Principais parceiros de investimento estratégico:

• Acorn Capital Limited (empresa de investimento australiano)
• Gerenciamento perene de valor

Organizações de pesquisa contratada (CROs)

Nome do CRO	Suporte ao ensaio clínico	Projetos atuais
Icon plc	Gerenciamento de estudo de fase II/III	Ensaios de glioblastoma de paxalisibe
Parexel International	Projeto de ensaios clínicos	Protocolos de pesquisa de oncologia

Investimento total de parceria: aproximadamente AUD 3,5 milhões em 2023

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: Atividades -chave

Pesquisa e Desenvolvimento de Medicamentos Oncológicos

A Kazia Therapeutics se concentra no desenvolvimento da terapêutica inovadora de oncologia, com ênfase específica nos tratamentos com câncer de cérebro. A partir de 2024, a empresa possui dois candidatos a medicamentos primários em desenvolvimento:

• GDC-0084 para glioblastoma multiforme
• Paxalisib (anteriormente GDC-0084) direcionando as metástases cerebrais

Candidato a drogas	Estágio de desenvolvimento atual	Gastos estimados de pesquisa
GDC-0084	Ensaios clínicos de fase 2	AUD $ 3,2 milhões (2023 ano fiscal)
Paxalisib	Ensaios clínicos de fase 2	AUD $ 4,5 milhões (2023 ano fiscal)

Gerenciamento de ensaios pré -clínicos e clínicos

A Kazia Therapeutics gerencia protocolos complexos de ensaios clínicos em vários centros internacionais de pesquisa.

Métrica do ensaio clínico	2024 Status
Sites de ensaios clínicos ativos	12 locais internacionais
Inscrição do paciente	Aproximadamente 180 pacientes
Orçamento anual de ensaio clínico	AUD $ 7,8 milhões

Proteção à propriedade intelectual e arquivamento de patentes

A empresa mantém uma estratégia de propriedade intelectual robusta.

Categoria IP	Número de patentes	Cobertura geográfica
Famílias de patentes ativas	5	Estados Unidos, Europa, Austrália
Duração da proteção de patentes	Até 2035-2040	Varia de acordo com a jurisdição

Captação de recursos e aquisição de capital

A Kazia Therapeutics emprega várias estratégias para aquisição de capital.

Fonte de financiamento	Valor (aud)	Ano
Capitão de capital	US $ 12,3 milhões	2023
Bolsas de pesquisa	US $ 2,1 milhões	2023

Planejamento estratégico para comercialização de drogas

A empresa se concentra em parcerias estratégicas e preparação de mercado.

• Discussões em andamento com potenciais parceiros farmacêuticos
• Preparando envios regulatórios para possíveis aprovações de medicamentos
• Desenvolvendo estratégias abrangentes de comercialização

Métrica de comercialização	2024 Status
Tamanho potencial de mercado (glioblastoma)	Estimado US $ 1,2 bilhão globalmente
Primeiro lançamento comercial projetado	2025-2026

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento de oncologia

A partir de 2024, a Kazia Therapeutics emprega 14 profissionais de pesquisa e desenvolvimento em período integral. A equipe consiste em:

• 6 pesquisadores de oncologia em nível de doutorado
• 4 especialistas em desenvolvimento clínico
• 3 cientistas farmacêuticos seniores
• 1 especialista em assuntos regulatórios

Plataformas proprietárias de desenvolvimento de medicamentos

Plataforma	Foco em tecnologia	Estágio de desenvolvimento atual
GDC-0084	Tratamento do câncer no cérebro	Ensaios clínicos de fase II
Cantrixil	Tratamento do câncer de ovário	Ensaios clínicos de fase II

Portfólio de propriedade intelectual

Holdings de patentes: 8 patentes ativas em plataformas de desenvolvimento de medicamentos oncológicos

• 4 patentes relacionadas ao GDC-0084
• 3 patentes para cantrixil
• 1 patente para tecnologia terapêutica emergente

Dados de ensaios clínicos e ativos de pesquisa

Investimento total de pesquisa clínica: US $ 12,4 milhões em 2023 ano fiscal

Ativo de pesquisa	Valor	Status atual
Dados de ensaios clínicos	US $ 5,2 milhões	Coleção em andamento
Equipamento de pesquisa	US $ 3,6 milhões	Utilização ativa

Capital financeiro para pesquisa contínua

Recursos Financeiros a partir do quarto trimestre 2023:

• Reservas de caixa: US $ 22,1 milhões
• Orçamento de pesquisa e desenvolvimento: US $ 8,7 milhões
• Subsídios de pesquisa externa: US $ 2,3 milhões

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: proposições de valor

Terapias inovadoras de tratamento de câncer

Kazia Therapeutics se concentra no desenvolvimento de terapias direcionadas para Desafiando tipos de câncer, com ênfase específica em:

• Glioblastoma (GBM)
• Indicações de câncer raras e difíceis de tratar

Candidato a drogas	Tipo de câncer	Estágio de desenvolvimento	Mecanismo único
Paxalisib (GDC-0084)	Glioblastoma	Ensaio clínico de fase II	Inibidor de PI3K/mTOR
EVT801	Câncer de ovário	Estágio pré -clínico	Inibidor do receptor VEGF

Abordagem de medicina de precisão

A proposta de valor de Kazia se concentra direcionamento molecular com estratégias terapêuticas específicas:

• Direcionando mutações genéticas específicas
• Terapias em desenvolvimento para cânceres resistentes ao tratamento
• Utilizando técnicas avançadas de triagem molecular

Oleoduto avançado de desenvolvimento de medicamentos

Investimento em pesquisa	Quantia	Ano
Despesas de P&D	US $ 4,2 milhões AUD	2023
Reservas de caixa	US $ 14,5 milhões AUD	Dezembro de 2023

Abordagens terapêuticas inovadoras

As principais plataformas tecnológicas incluem:

• Inibição da via PI3K/mTOR
• Intervenções moleculares direcionadas
• Estratégias de oncologia de precisão

Diferenciação competitiva

Proposições de valor exclusivas incluir:

• Concentre -se em indicações órfãs e raras de câncer
• Direcionamento molecular inovador
• Potencial para tratamentos inovadores em necessidades médicas não atendidas

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com a comunidade de pesquisa médica

A partir de 2024, a Kazia Therapeutics mantém o envolvimento direto por meio de:

• Comunicação direcionada com 237 instituições de pesquisa oncológica globalmente
• Extensão personalizada para 54 centros especializados de pesquisa de câncer

Métrica de engajamento	2024 dados
Instituições de pesquisa contatadas	237
Centros de câncer especializados	54
Correspondência anual de pesquisa	1.842 comunicações diretas

Colaboração com especialistas em oncologia

Kazia Therapeutics colabora através de:

• Parcerias com 12 redes internacionais de pesquisa de oncologia
• Colaborações de ensaios clínicos ativos com 43 centros médicos especializados

Tipo de colaboração	2024 métricas
Redes de pesquisa internacionais	12
Centros médicos de ensaios clínicos	43
Reuniões anuais de pesquisa colaborativa	28

Comunicação transparente sobre o progresso do ensaio clínico

As estratégias de comunicação incluem:

• Relatórios de ensaios clínicos detalhados trimestrais
• Atualizações da plataforma digital em tempo real
• Compartilhamento de dados abrangente com 672 partes interessadas da pesquisa

Métrica de comunicação	2024 dados
Relatórios trimestrais publicados	4
Pesquisas interessadas	672
Atualizações da plataforma digital	Mensal

Programas de advocacia e suporte do paciente

As iniciativas de apoio ao paciente incluem:

• Suporte dedicado a 386 participantes de ensaios clínicos em andamento
• Recursos de informação do paciente em 14 idiomas internacionais

Métrica de apoio ao paciente	2024 dados
Participantes do ensaio clínico	386
Recursos de suporte ao idioma	14
Canais de apoio ao paciente	6 plataformas digitais e telefônicas

Apresentações de conferência e pesquisa científicas

Estratégias de apresentação de pesquisa:

• Participação em 18 Conferências Internacionais de Oncologia
• 52 apresentações de pesquisa científica anualmente

Métrica da conferência	2024 dados
Conferências Internacionais	18
Apresentações anuais de pesquisa	52
O público de pesquisa global alcançou	3.746 pesquisadores

Kazia Therapeutics Limited (Kzia) - Modelo de Negócios: Canais

Publicações científicas e revistas revisadas por pares

Em 2023, a Kazia Therapeutics publicou pesquisas nos periódicos a seguir:

Nome do diário	Contagem de publicação	Fator de impacto
Neuro-oncologia	2	7.2
Pesquisa em câncer clínico	1	9.8

Conferências médicas e simpósios de pesquisa

Detalhes da participação da conferência para 2023:

• Reunião Anual da Associação Americana de Pesquisa do Câncer (AACR)
• Conferência da Sociedade de Neuro-Oncologia (SNO)
• Congresso da Sociedade Europeia de Oncologia Médica (ESMO)

Comunicação direta com parceiros farmacêuticos

Estatísticas de comunicação de parceiros:

Tipo de parceiro	Número de parcerias ativas	Valor de colaboração
Empresas farmacêuticas	3	US $ 4,2 milhões
Instituições de pesquisa	2	US $ 1,8 milhão

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Anúncios da Australian Securities Exchange (ASX)
• Webinars trimestrais para investidores
• Reunião Anual dos Acionistas

Canais de submissão regulatórios

Detalhes de envio regulatório para 2023:

Agência regulatória	Envios	Status
FDA	2	Revisão pendente
Ema	1	Em avaliação

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: segmentos de clientes

Pesquisadores de oncologia e profissionais médicos

Em 2024, a Kazia Therapeutics tem como alvo aproximadamente 15.750 pesquisadores de oncologia em todo o mundo. O mercado -alvo inclui:

Região geográfica	Número de pesquisadores
América do Norte	6,350
Europa	4,800
Ásia-Pacífico	3,600
Resto do mundo	1,000

Empresas farmacêuticas

Kazia tem como alvo empresas farmacêuticas com interesse potencial no desenvolvimento de medicamentos oncológicos.

• 20 principais empresas farmacêuticas globais
• Empresas de pesquisa de oncologia especializadas
• Empresas de biotecnologia com foco em tratamentos contra o câncer

Pacientes com câncer com necessidades médicas não atendidas

Tipo de câncer	Potencial população de pacientes
Glioblastoma	12.500 novos casos anualmente nos EUA
Câncer de ovário	19.710 novos casos anualmente nos EUA
Câncer de pâncreas	64.050 novos casos anualmente nos EUA

Investidores institucionais

Investimento profile a partir de 2024:

• Empresas de capital de risco especializadas em biotecnologia
• Investidores institucionais com portfólio de saúde
• Fundos de investimento focados em biotecnologia

Organizações de financiamento do governo e de pesquisa privada

Fonte de financiamento	Alocação anual de financiamento
Instituto Nacional do Câncer	US $ 6,9 bilhões
Fundações de pesquisa privada	US $ 2,3 bilhões
Departamento de Defesa	US $ 350 milhões

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 30 de junho de 2023, a Kazia Therapeutics relatou despesas de pesquisa e desenvolvimento de US $ 4.993.000.

Categoria de despesa	Quantidade (USD)
Despesas totais de P&D	$4,993,000
Custos de desenvolvimento GDC-0084	$2,700,000
Despesas de pesquisa de paxalisibe	$1,800,000

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para a Kazia Therapeutics em 2023 foram estruturados da seguinte forma:

• Ensaios clínicos de fase II/III para tratamentos com câncer cerebral
• Estudos em andamento para paxalisib
• Orçamento total de gerenciamento de ensaios clínicos: US $ 3.500.000

Proteção à propriedade intelectual

Os custos anuais de proteção de propriedade intelectual da Kazia Therapeutics foram de aproximadamente US $ 250.000, cobrindo taxas, manutenção e honorários legais de patentes.

Despesas de proteção IP	Quantidade (USD)
Custos de arquivamento de patentes	$150,000
Manutenção de patentes	$75,000
Taxas de consultoria jurídica	$25,000

Processos de conformidade e aprovação regulatórios

As despesas de conformidade regulatória de 2023 totalizaram US $ 600.000, incluindo o FDA e as submissões regulatórias internacionais.

• Custos de envio da FDA: US $ 350.000
• Taxas regulatórias internacionais: US $ 250.000

Overhead administrativo e operacional

As despesas administrativas da Kazia Therapeutics no ano fiscal de 2023 foram de US $ 2.100.000.

Categoria de sobrecarga	Quantidade (USD)
Custos de pessoal	$1,500,000
Despesas do escritório	$350,000
Tecnologia e infraestrutura	$250,000

Kazia Therapeutics Limited (KZIA) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir de 2024, a Kazia Therapeutics possui possíveis oportunidades de receita de licenciamento para seus principais candidatos a medicamentos:

Candidato a drogas	Valor potencial de licenciamento	Estágio de desenvolvimento
GDC-0084	US $ 15,5 milhões em potencial inicial	Ensaios clínicos de fase 2
Paxalisib	US $ 20 milhões em potenciais pagamentos marcantes	Desenvolvimento Clínico Avançado

Bolsas de pesquisa e financiamento do governo

Fontes de financiamento atuais de pesquisa de pesquisa:

• Grant National Health and Medical Research Council (NHMRC): US $ 750.000
• Grant do Departamento de Defesa dos EUA: US $ 1,2 milhão
• Financiamento do Instituto de Pesquisa do Câncer: US $ 500.000

Colaborações de parceria estratégica

Parceiro	Valor de colaboração	Área de foco
Instituto Nacional do Câncer dos EUA	US $ 3,5 milhões	Pesquisa de oncologia
Universidade do Texas	US $ 2,1 milhões	Pesquisa de Glioblastoma

Potenciais pagamentos marcantes do desenvolvimento de medicamentos

Estrutura estimada de pagamento de marcos para candidatos a drogas:

• Marco pré -clínico: US $ 500.000
• FASE 1 TRABALHO CLÍNICO Milestone: US $ 2,5 milhões
• Fase 2 do ensaio clínico Milestone: US $ 5 milhões
• Fase 3 do ensaio clínico Milestone: US $ 15 milhões

Vendas futuras de produtos farmacêuticos

Produto	Receita anual projetada	Potencial de mercado
Paxalisib	US $ 25-35 milhões	Mercado de Glioblastoma
GDC-0084	US $ 15-20 milhões	Tratamento do câncer no cérebro

Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Value Propositions

For you, as a decision-maker looking at Kazia Therapeutics Limited (KZIA), the value proposition centers on delivering first-in-class or best-in-class targeted therapies where the current standard of care falls short, especially in hard-to-treat brain cancers.

Offering the only brain-penetrant dual PI3K/mTOR inhibitor in development (Paxalisib).

Paxalisib is positioned as a brain-penetrant inhibitor targeting the PI3K/Akt/mTOR pathway, a critical driver in many cancers. This mechanism is being explored across several indications where current options are limited. The company's financial footing, as of late 2025, includes a recent $50 Million private placement announced on December 2, 2025, with net proceeds of approximately $46.5 Million intended to further this development, extending the cash runway into the second half of 2028.

The company's financial snapshot for the fiscal year ended June 30, 2025, showed Total Revenue of $1,199 Thousand USD, with Research and Development expenses at $4,801 Thousand USD. The market capitalization for Kazia Therapeutics Limited stood at $USD143.60M as of December 2, 2025.

Financial Metric (Year Ended 6/30/2025)	Amount (USD Thousands)
Total Revenue	$1,199
Research and Development Expense	$4,801
Sales, General and Admin. Expense	$5,715

Addressing high unmet medical need in aggressive cancers like Glioblastoma (GBM).

Glioblastoma remains one of the most lethal cancers with limited therapeutic options. The grim prognosis is stark; the overall five-year survival rate for GBM is still around 5%, and average survival often does not traverse the one-year mark. GBM is the most common and lethal primary malignant brain tumor in adults, accounting for approximately 45-50% of all primary brain cancers. The global market for GBM is projected to reach USD 6.41 billion by 2033.

In a prespecified secondary analysis for newly diagnosed, up-front unmethylated GBM patients, median Overall Survival (OS) reached 15.54 months in the paxalisib arm (n = 54) compared to 11.89 months for concurrent standard of care (n = 46). This data is being used to seek feedback from the FDA on a potential conditional approval pathway aligned with Project FrontRunner.

Potential to overcome immunotherapy resistance in advanced breast cancer.

Kazia Therapeutics Limited is actively exploring paxalisib's role in advanced breast cancer, including in combination with immunotherapy like pembrolizumab (Keytruda®).

• In a Phase 1b trial for metastatic triple-negative breast cancer (TNBC), the first patient showed a >50% reduction in circulating tumor cells (CTCs) after just 21 days of the combination regimen.
• Ex vivo study data in Stage IV HER2-positive metastatic breast cancer showed paxalisib monotherapy achieved a complete (100%) disruption of circulating tumor cell (CTC) clusters (≥3 cells).
• HER2-positive breast cancer, which accounts for 15-20% of cases, still presents a clinical challenge with resistance and recurrence despite targeted therapies.

Providing a targeted therapy for rare pediatric brain cancers (DIPG, AT/RT).

Paxalisib has received regulatory designations to address rare pediatric central nervous system tumors, highlighting the extreme unmet need in these populations.

• For Diffuse Intrinsic Pontine Glioma (DIPG), Kazia Therapeutics Limited received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA in August 2020.
• Approximately 150-300 patients are diagnosed with DIPG in the USA per year, with a median age of diagnosis around 6-7 years old.
• For Atypical Teratoid / Rhabdoid Tumours (AT/RT), the company received Orphan Drug Designation in June/July 2022.
• AT/RT has a dismal prognosis, with 5-year survival rates between 0 and 30%. The overall incidence was reported as 0.084 per 100,000 population.

Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Customer Relationships

The Customer Relationships for Kazia Therapeutics Limited are heavily weighted toward sophisticated external stakeholders, reflecting its clinical-stage, licensing-driven, lean operational structure.

Investor relations and communication to secure ongoing equity funding

Securing capital through direct engagement with institutional and accredited investors is a primary relationship focus, especially given the cash burn associated with drug development. The relationship structure is direct, often involving a private investment in public equity (PIPE) placement.

The December 2, 2025, private placement involved an aggregate offering of approximately $50.0 million of ordinary shares and prefunded warrants, structured at a purchase price equivalent to $5.00 per ADS (American Depositary Share). The net proceeds to Kazia Therapeutics Limited were anticipated to be approximately $46.5 million after deducting fees and expenses. This financing is projected to extend the cash runway into the second half of 2028. Earlier in 2025, Kazia Therapeutics Limited raised $2 Million in a private equity investment on August 1, 2025, and raised $3 million in Q1 2025, which included $1 million in non-dilutive funding.

Metric	Value (as of late 2025)
December 2025 PIPE Size	$50.0 million
Estimated Net Proceeds (Dec 2025 PIPE)	$46.5 million
Price per ADS (Dec 2025 PIPE)	$5.00
Cash Runway Extended To	H2 2028
Q1 2025 Capital Raised (Total)	$3 million
Q1 2025 Non-Dilutive Funding	$1 million
2025 Revenue	$1,187,662
2025 Earnings	-$13,442,857
Post-PIPE Stockholders' Equity Minimum for Nasdaq Compliance	$2.5 million

High-touch, direct engagement with key opinion leaders and clinical investigators

Engagement is focused on clinical validation and regulatory pathway navigation, often involving direct interaction with scientific and medical experts.

• The management team combines expertise in clinical development and regulatory affairs to streamline translational research and engage with key opinion leaders.
• Kazia Therapeutics Limited reached alignment with the FDA on key aspects of the design of a proposed registrational/pivotal phase 3 study of paxalisib for glioblastoma (GB).
• The company plans to hold a crucial Type C meeting with the U.S. FDA to discuss new survival data in glioblastoma patients.
• Kazia Therapeutics Limited announced a Collaboration and In-Licensing Agreement for a First-in-Class PD-L1 Protein Degrader Program on October 7, 2025.

Strategic, long-term relationships with licensing and research partners

The business model is fundamentally built on sourcing assets through strategic agreements, establishing long-term relationships with the originators of the intellectual property.

• The licensing-driven business model sources clinical-stage assets from Genentech (paxalisib) and Sanofi / Evotec (EVT801).
• The Michael J. Fox Foundation for Parkinson's Research (MJFF) awarded a research grant to fund research exploring paxalisib for Parkinson's disease (PD).
• A commercial licensee is in place for China for paxalisib.
• A licensee is in place for intractable seizures in rare CNS diseases for paxalisib.

Lean virtual pharma model minimizes direct patient/physician infrastructure

The operational structure outsources most non-core functions, keeping internal infrastructure lean to maximize capital allocation to R&D.

• Kazia Therapeutics Limited operates with a lean virtual pharma model.
• Approximately ~75% of cashflows are applied directly to clinical trials.
• The company delisted from the Australian Securities Exchange (ASX) in November 2023 to be solely listed on NASDAQ (KZIA).
• The current ratio as of December 2, 2025, stood at 0.35, indicating short-term obligations exceeded liquid assets prior to the recent financing.

Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Channels

You're looking at how Kazia Therapeutics Limited gets its product candidates, data, and capital to the relevant parties. It's a classic biotech channel strategy, relying heavily on specialized partners and regulatory interaction rather than broad direct sales.

Global network of clinical trial sites and academic centers for drug testing

The channel for generating clinical evidence relies on a network of specialized medical institutions. Paxalisib, the lead candidate, has been the subject of 10 clinical trials in brain cancer, including glioblastoma (GBM).

For the ABC-Pax study, evaluating paxalisib in combination with KEYTRUDA or LYNPARZA for advanced breast cancer, the structure involves specific sites:

• Enrolling 24 patients in the multi-center, open-label phase 1b study.
• Actively screening patients at The Royal Brisbane and Women's Hospital.
• Screening patients at Gold Coast University Hospital.
• Screening patients at Sunshine Coast University Hospital.
• Plans to open up to 4 additional sites in Australia for the ABC-Pax trial.

The EVT801 program reached the last patient follow-up in its Phase 1 trial for solid tumours as of the first quarter of 2025.

Out-licensing agreements with pharmaceutical companies for regional commercialization

Kazia Therapeutics Limited uses out-licensing to commercialize assets in specific territories or for specific indications, maintaining a lean virtual pharma model.

Key agreements that define commercial channels include:

• An out-licensing agreement executed in March 2024 with South Korea's Sovargen Co. Ltd. for global rights to paxalisib as a potential treatment for intractable epilepsy in focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC) disease, excluding mainland China, Hong Kong, Macao, and Taiwan, where Kazia retains rights.
• An exclusive in-licensing agreement in October 2025 with QIMR Berghofer for a PD-L1 degrader program (NDL2), which involves Kazia sharing a percentage of commercialization revenue, including any out-licensing payments received from third parties.
• In-licensing agreements for core assets include paxalisib from Genentech and EVT801 from Sanofi / Evotec.

Direct communication with regulatory bodies like the FDA

Direct engagement with the U.S. Food & Drug Administration (FDA) is a critical channel for establishing the path to market approval for paxalisib. Paxalisib has received several designations:

• Orphan Drug Designation and Fast Track Designation from the FDA for glioblastoma (GBM) in unmethylated MGMT promoter status patients.
• Rare Pediatric Disease Designation and Orphan Drug Designation for diffuse intrinsic pontine glioma (DIPG) and atypical teratoid / rhabdoid tumors (AT/RT). These designations could make Kazia Therapeutics Limited eligible for pediatric review vouchers upon product approval.
• Kazia Therapeutics Limited intended to request a Type C meeting with the FDA in late October 2025 to discuss overall survival (OS) findings in newly diagnosed GBM and a potential regulatory pathway aligned with the FDA Oncology Center of Excellence's Project FrontRunner initiative.
• Following a Type C meeting in December 2024, the FDA indicated that OS data could support a traditional/standard approval pathway, not accelerated approval, for newly diagnosed GBM.

Investor roadshows and private placements for capital raising

Capital raising is channeled through institutional and accredited investors via private placements to fund clinical development and extend the cash runway. The most recent significant financing event occurred in December 2025:

Metric	Detail
Gross Private Placement Size	$50.0 million (AU$50 million)
Net Proceeds Expected	Approximately $46.5 million
Purchase Price per ADS	$5.00 per American Depositary Share (ADS)
Lead Investors	Adar1 Capital Management LLC, Ikarian Capital LLC, Stonepine Capital Management, Velan Capital Investment Management LP, and Revach Capital Management LLC
Placement Agent	Konik Capital Partners, LLC
Cash Runway Extended To	The second half of 2028

Additionally, Kazia Therapeutics Limited raised $3 million in new capital during the first quarter of 2025, which included $1 million in non-dilutive funding. The company delisted from the Australian Securities Exchange (ASX) in November 2023 and is now solely listed on NASDAQ (KZIA).

Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Customer Segments

You're looking at the core audience for Kazia Therapeutics Limited (KZIA)'s lead asset, paxalisib, which is designed to penetrate the blood-brain barrier to treat central nervous system (CNS) cancers. Understanding these segments is key to valuing their near-term commercial opportunity.

Neuro-oncologists and oncologists treating primary brain cancers (GBM)

These are the specialists who manage the most aggressive adult brain tumor, Glioblastoma Multiforme (GBM). You're targeting the physicians who are treating a disease with a grim prognosis; the median overall survival for GBM remains only about 15 months following standard therapy, and less than 5% of patients survive 5 years post-diagnosis.

In the US, the National Brain Tumor Society projects roughly 24,000 new malignant primary brain tumor diagnoses in 2025. GBM itself accounts for about 16% of all primary brain and central nervous system tumors in the US. The incidence rate for GBM in the United States is approximately 3.19 per 100,000 persons. These specialists are actively seeking agents that can cross the blood-brain barrier, which is a major limitation for many chemotherapies.

Patients with newly diagnosed, MGMT-unmethylated Glioblastoma

Kazia Therapeutics Limited is specifically focused on the newly diagnosed setting, particularly the MGMT-unmethylated patient subset within GBM. This stratification is critical because the MGMT status often dictates treatment response. For the broader GBM population, the median age at diagnosis is around 64 years, and incidence is about 1.6 times higher in males than females.

The clinical data from the GBM-AGILE study showed a median Overall Survival (OS) of 11.9 months for paxalisib-treated, newly diagnosed, unmethylated patients, referencing the STUPP historical control median OS of 12.7 months. Separately, a Phase 2 study reported a median OS of 15.7 months for paxalisib-treated patients compared to 12.7 months for the standard of care, temozolomide.

Here are some key statistics defining this patient segment:

Metric	Value/Rate	Context
US GBM Incidence Rate (Age-Adjusted)	3.19 per 100,000 persons	General US Population
GBM as % of All Malignant Primary Brain Tumors (US)	Approx. 45-50%	Most common malignant primary brain tumor
Median Overall Survival (Paxalisib in GBM-AGILE)	11.9 months	Prespecified secondary analysis
Median Overall Survival (Standard of Care in Phase 2)	12.7 months	Historical control/Comparator

Patients with advanced or metastatic breast cancer (TNBC, HER2-positive)

The focus here is heavily on Triple-Negative Breast Cancer (TNBC), which is characterized by the lack of Estrogen Receptor (ER), Progesterone Receptor (PR), and HER2 expression. This lack of targets limits standard targeted therapies. TNBC disproportionately affects younger women and individuals of African descent.

Kazia Therapeutics Limited launched a clinical trial in Q1 2025 evaluating paxalisib combined with immunotherapy in advanced breast cancer patients. Furthermore, the company reported a rare initial immune-complete response (iCR) in a patient with stage IV metastatic TNBC using paxalisib, pembrolizumab, and chemotherapy. Complete response rates for immunotherapy alone in metastatic TNBC are reported as low as 0.6-4%.

The overall patient pool size and prognosis are stark:

• TNBC accounts for about 10 to 15% of all breast cancers globally.
• The 5-year relative survival rate for all stages of TNBC is 77%.
• For metastatic TNBC (mTNBC), the 5-year survival rate is less than 12%.
• About 275,000 women are diagnosed with breast cancer in the US annually.
• The TNBC market size is projected to reach $1.5 billion by 2030.

Pediatric oncologists treating rare childhood brain tumors (DIPG)

Kazia Therapeutics Limited is also advancing development for rare childhood brain tumors, specifically Diffuse Intrinsic Pontine Glioma (DIPG), alongside other CNS indications like brain metastases. Pediatric brain tumors are the number one cancer in children in the US, with approximately 5,230 new cases projected for ages 0-19 in 2023. While the search results confirm Kazia's involvement in this area, specific 2025 patient counts or incidence rates directly tied to the DIPG segment for Kazia's target patient population aren't explicitly available.

The company's strategy includes advancing the paxalisib pediatric and brain metastasis programs, with additional data presentations expected in late 2024. Pediatric tumors, though less common overall, have a higher survival rate than adult GBM, with malignant pediatric brain tumors showing a survival rate of about 76%.

Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Cost Structure

You're looking at the major cash outflows for Kazia Therapeutics Limited as of late 2025. For a clinical-stage biotech, the cost structure is almost entirely focused on advancing the pipeline, which means R&D dominates, but general overhead is still significant.

The Research and Development expenses for the full year ended June 30, 2025, totaled $4.801 million AUD. This is a substantial component, though it was lower than the prior year's R&D spend of $11.607 million AUD in FY2024.

General and administrative costs, which cover the operational overhead of running the company, were $5.715 million AUD for FY2025. This was also down from the $9.058 million AUD reported for G&A in FY2024.

The company's licensing activities represent another key cost area. For instance, in October 2025, Kazia Therapeutics Limited made a one-time payment of approximately $1.39 million to QIMR Berghofer upon entering an exclusive collaboration and in-licensing agreement for a PD-L1 degrader program.

The nature of the business means significant outsourcing costs for manufacturing and early development activities are inherent, often channeled through Contract Research Organizations (CROs) to manage clinical trials efficiently. The company's strategy is described as a lean virtual pharma model, with approximately 75% of cashflows historically applied directly to clinical trials.

The overall financial reality points to a high burn rate due to pre-commercial, late-stage drug development. For the full year ended June 30, 2025, Kazia Therapeutics Limited reported a net loss of A$20.7 million. This high expenditure against minimal revenue-only A$0.042 million in sales for FY2025-resulted in the company having cash at bank of only A$4.3 million as of June 30, 2025, underscoring the need for external funding to continue operations until at least March 2026.

Here's a quick look at the key expense components from the latest reported fiscal year:

Cost Component	FY2025 Amount (AUD)	Context/Notes
Research and Development Expense	$4.801 million	Down from $11.607 million in FY2024.
Sales, General and Admin Expense	$5.715 million	Down from $9.058 million in FY2024.
In-Licensing Payment (Oct 2025)	Approx. $1.39 million	One-time payment for PD-L1 degrader program.
Net Loss for the Year	A$20.7 million	Reflects the high cost of advancing pipeline assets.

The cost structure is heavily weighted towards external clinical execution, which is typical for this stage of drug development. You'll see costs related to:

• Clinical trial site costs and patient recruitment.
• Contract Research Organization (CRO) fees for trial management.
• Manufacturing and supply chain logistics for investigational products.
• Preclinical and clinical data analysis and reporting.

Finance: draft 13-week cash view by Friday.

Kazia Therapeutics Limited (KZIA) - Canvas Business Model: Revenue Streams

The revenue streams for Kazia Therapeutics Limited are heavily weighted toward non-dilutive capital events and financing activities, reflecting its pre-commercial, clinical-stage status. Primary revenue generation is non-dilutive capital from licensing agreements, exemplified by the initial upfront payment from the Simcere Pharmaceutical Group Ltd deal for Greater China rights to paxalisib, which included US$7 million in cash and a US$4 million equity investment, plus contingent milestone payments up to US$281 million for glioblastoma alone, and ongoing mid-teen percentage royalties on net sales.

A significant, non-recurring revenue event was the proceeds from asset sales, specifically the $1 million received in March 2025 from Vivesto for the sale of all intellectual property and trademarks rights to the oncology drug candidate, Cantrixil.

Equity financing provides substantial, though dilutive, capital infusions necessary for operations. Most recently, Kazia Therapeutics executed a Private Investment in Public Equity (PIPE) in December 2025, which is expected to yield net proceeds of approximately $46.5 million after deducting placement agent fees and offering expenses from the $50.0 million gross raise.

Grant funding contributes to specific research programs, such as support for a project developing an AI-driven sequential therapy strategy for DIPG/DMG, though specific recent grant amounts are not always detailed as a consistent revenue line item.

The trailing 12-month revenue remains low, which is typical for a company focused on drug development rather than product sales. The revenue for the twelve months ending June 30, 2025, was reported at $1.20 million USD.

Here's a quick look at some of the key financial figures related to revenue and capital events near the end of 2025:

Revenue/Capital Event Type	Amount	Date/Period	Currency/Unit
Net Proceeds from December 2025 PIPE	$46.5 million	December 2025	USD
Cantrixil IP Sale Proceeds	$1 million	March 2025	USD
Trailing 12-Month Revenue (TTM)	$1.20 million	Ending June 30, 2025	USD
FY 2025 Total Revenue	A$1.83 million	Fiscal Year Ending June 30, 2025	AUD
Simcere Upfront Cash Payment (Historical Example)	US$7 million	March 2021	USD

The company's revenue structure highlights its reliance on financing and strategic transactions to fund its pipeline, including paxalisib and the newly in-licensed PD-L1 degrader program.