Kazia Therapeutics Limited (KZIA): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama en rápida evolución de la investigación de oncología, Kazia Therapeutics Limited (KZIA) emerge como una fuerza pionera, transformando la forma en que abordamos el tratamiento del cáncer a través de estrategias innovadoras de desarrollo de medicamentos. Al aprovechar un modelo de negocio sofisticado que une la investigación científica de vanguardia con asociaciones estratégicas, Kzia no es solo otra compañía de biotecnología, sino un posible cambio de juego en los tipos de cáncer complejos y raros. Su enfoque único se centra en las terapias innovadoras para los cánceres desafiantes como el glioblastoma, colocándolos a la vanguardia de la medicina de precisión y ofreciendo esperanza donde los tratamientos tradicionales se han quedado corto.

Kazia Therapeutics Limited (KZIA) - Modelo de negocios: asociaciones clave

Instituciones de investigación académica colaboración

Kazia Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de colaboración	Año establecido
Centro de cáncer de Anderson de la Universidad de Texas	Investigación de Paxalisib (GDC-0084)	2018
Escuela de Medicina de Harvard	Desarrollo de medicamentos oncológicos	2020

Asociaciones de la compañía farmacéutica

Las colaboraciones farmacéuticas actuales incluyen:

• Genentech (subsidiaria de Roche) para el apoyo de ensayos clínicos de Paxalisib
• Programa de Desarrollo de Medicamentos del Instituto Nacional del Cáncer (NCI)

Interacciones gubernamentales y de agencia regulatoria

Agencia	Tipo de interacción	Estado
Administración de Alimentos y Medicamentos de los Estados Unidos (FDA)	Aplicación de nueva droga de investigación (IND)	Aprobado para Paxalisib
Administración de bienes terapéuticos australianos	Cumplimiento regulatorio	Compromiso activo

Inversores estratégicos en investigación oncológica

Socios de inversión estratégica clave:

• Acorn Capital Limited (firma de inversión australiana)
• Gestión del valor perenne

Organizaciones de investigación por contrato (CRO)

Nombre de Cro	Apoyo de ensayos clínicos	Proyectos actuales
Ícono plc	Gestión de ensayos de fase II/III	Ensayos de glioblastoma de paxalisib
Parexel International	Diseño de ensayo clínico	Protocolos de investigación oncológica

Inversión total de asociación: aproximadamente AUD 3.5 millones en 2023

Kazia Therapeutics Limited (KZIA) - Modelo de negocios: actividades clave

Investigación y desarrollo de drogas oncológicas

Kazia Therapeutics se centra en el desarrollo de la terapéutica innovadora oncológica con un énfasis específico en los tratamientos de cáncer cerebral. A partir de 2024, la compañía tiene dos candidatos de drogas principales en desarrollo:

• GDC-0084 para glioblastoma multiforme
• Paxalisib (anteriormente GDC-0084) dirigido a metástasis cerebrales

Candidato a la droga	Etapa de desarrollo actual	Gasto de investigación estimado
GDC-0084	Ensayos clínicos de fase 2	AUD $ 3.2 millones (2023 año fiscal)
Paxalisib	Ensayos clínicos de fase 2	AUD $ 4.5 millones (2023 año fiscal)

Gestión de ensayos preclínicos y clínicos

Kazia Therapeutics administra protocolos de ensayos clínicos complejos en múltiples centros de investigación internacionales.

Métrico de ensayo clínico	Estado 2024
Sitios de ensayos clínicos activos	12 ubicaciones internacionales
Inscripción del paciente	Aproximadamente 180 pacientes
Presupuesto anual de ensayo clínico	AUD $ 7.8 millones

Protección de propiedad intelectual y presentación de patentes

La Compañía mantiene una sólida estrategia de propiedad intelectual.

Categoría de IP	Número de patentes	Cobertura geográfica
Familias de patentes activas	5	Estados Unidos, Europa, Australia
Duración de protección de patentes	Hasta 2035-2040	Varía según la jurisdicción

Recaudación de fondos y adquisición de capital

Kazia Therapeutics emplea múltiples estrategias para la adquisición de capital.

Fuente de financiación	Cantidad (AUD)	Año
Cría de capital	$ 12.3 millones	2023
Subvenciones de investigación	$ 2.1 millones	2023

Planificación estratégica para la comercialización de drogas

La compañía se centra en asociaciones estratégicas y preparación del mercado.

• Discusiones continuas con posibles socios farmacéuticos
• Preparación de presentaciones regulatorias para aprobaciones potenciales de medicamentos
• Desarrollo de estrategias integrales de comercialización

Métrico de comercialización	Estado 2024
Tamaño potencial del mercado (glioblastoma)	Estimado $ 1.2 mil millones a nivel mundial
Primer lanzamiento comercial proyectado	2025-2026

Kazia Therapeutics Limited (KZIA) - Modelo de negocios: recursos clave

Equipo de Investigación y Desarrollo de Oncología Especializada

A partir de 2024, Kazia Therapeutics emplea a 14 profesionales de investigación y desarrollo a tiempo completo. El equipo consiste en:

• 6 investigadores de oncología a nivel de doctorado
• 4 especialistas en desarrollo clínico
• 3 científicos farmacéuticos senior
• 1 experto en asuntos regulatorios

Plataformas de desarrollo de fármacos patentados

Plataforma	Enfoque tecnológico	Etapa de desarrollo actual
GDC-0084	Tratamiento del cáncer cerebral	Ensayos clínicos de fase II
Cantrixil	Tratamiento del cáncer de ovario	Ensayos clínicos de fase II

Cartera de propiedades intelectuales

Patentes: 8 patentes activas en plataformas de desarrollo de medicamentos oncológicos

• 4 patentes relacionadas con GDC-0084
• 3 Patentes para Cantrixil
• 1 patente para tecnología terapéutica emergente

Datos de ensayos clínicos y activos de investigación

Inversión total de investigación clínica: $ 12.4 millones a partir del año fiscal 2023

Activo de investigación	Valor	Estado actual
Datos de ensayos clínicos	$ 5.2 millones	Colección continua
Equipo de investigación	$ 3.6 millones	Utilización activa

Capital financiero para la investigación continua

Recursos financieros a partir del cuarto trimestre 2023:

• Reservas de efectivo: $ 22.1 millones
• Presupuesto de investigación y desarrollo: $ 8.7 millones
• Subvenciones de investigación externa: $ 2.3 millones

Kazia Therapeutics Limited (KZIA) - Modelo de negocio: propuestas de valor

Terapias innovadoras de tratamiento del cáncer

Kazia Therapeutics se centra en desarrollar terapias específicas para tipos de cáncer desafiantes, con énfasis específico en:

• Glioblastoma (GBM)
• Indicaciones de cáncer raras y difíciles de tratar

Candidato a la droga	Tipo de cáncer	Etapa de desarrollo	Mecanismo único
Paxalisib (GDC-0084)	Glioblastoma	Ensayo clínico de fase II	Inhibidor de PI3K/mTOR
EVT801	Cáncer de ovario	Etapa preclínica	Inhibidor del receptor de VEGF

Enfoque de medicina de precisión

La propuesta de valor de Kazia se centra en orientación molecular con estrategias terapéuticas específicas:

• Dirigido a mutaciones genéticas específicas
• Desarrollo de terapias para cánceres resistentes al tratamiento
• Utilización de técnicas avanzadas de detección molecular

Tubería avanzada de desarrollo de medicamentos

Inversión de investigación	Cantidad	Año
Gasto de I + D	$ 4.2 millones AUD	2023
Reservas de efectivo	$ 14.5 millones AUD	Diciembre de 2023

Enfoques terapéuticos innovadores

Las plataformas tecnológicas clave incluyen:

• Inhibición de la vía PI3K/mTOR
• Intervenciones moleculares dirigidas
• Estrategias oncológicas de precisión

Diferenciación competitiva

Propuestas de valor únicas incluir:

• Concéntrese en las indicaciones de cáncer huérfanos y raros
• Orientación molecular innovadora
• Potencial para los tratamientos innovadores en necesidades médicas no satisfechas

Kazia Therapeutics Limited (KZIA) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir de 2024, Kazia Therapeutics mantiene la participación directa a través de:

• Comunicación dirigida con 237 Instituciones de Investigación de Oncología A nivel mundial
• Alcance personalizado a 54 centros especializados de investigación del cáncer

Métrico de compromiso	2024 datos
Instituciones de investigación contactadas	237
Centros de cáncer especializados	54
Correspondencia de investigación anual	1.842 comunicaciones directas

Colaboración con especialistas en oncología

Kazia Therapeutics colabora a través de:

• Asociación con 12 redes internacionales de investigación de oncología
• Colaboraciones de ensayos clínicos activos con 43 centros médicos especializados

Tipo de colaboración	2024 métricas
Redes de investigación internacionales	12
Centros médicos de ensayos clínicos	43
Reuniones anuales de investigación colaborativa	28

Comunicación transparente sobre el progreso del ensayo clínico

Las estrategias de comunicación incluyen:

• Informes de ensayos clínicos detallados trimestralmente
• Actualizaciones de plataforma digital en tiempo real
• Compartir datos integrales con 672 partes interesadas de investigación

Métrico de comunicación	2024 datos
Informes trimestrales publicados	4
Interesados ​​de investigación	672
Actualizaciones de plataforma digital	Mensual

Programas de defensa y apoyo para pacientes

Las iniciativas de apoyo al paciente incluyen:

• Apoyo dedicado para 386 participantes en ensayos clínicos en curso
• Recursos de información del paciente en 14 idiomas internacionales

Métrica de apoyo al paciente	2024 datos
Participantes de ensayos clínicos	386
Recursos de soporte lingüístico	14
Canales de apoyo al paciente	6 plataformas digitales y telefónicas

Conferencias científicas y presentaciones de investigación

Estrategias de presentación de investigación:

• Participación en 18 Conferencias internacionales de oncología
• 52 Presentaciones de investigación científica anualmente

Métrico de conferencia	2024 datos
Conferencias internacionales	18
Presentaciones de investigación anuales	52
La audiencia de investigación global llegó	3.746 investigadores

Kazia Therapeutics Limited (KZIA) - Modelo de negocios: canales

Publicaciones científicas y revistas revisadas por pares

En 2023, Kazia Therapeutics publicó una investigación en las siguientes revistas:

Nombre del diario	Recuento de publicaciones	Factor de impacto
Neuro-oncología	2	7.2
Investigación del cáncer clínico	1	9.8

Conferencias médicas y simposios de investigación

Detalles de participación de la conferencia para 2023:

• Reunión anual de la Asociación Americana de Investigación del Cáncer (AACR)
• Conferencia Society for Neuro-Oncology (SNO)
• Congreso de la Sociedad Europea de Oncología Médica (ESMO)

Comunicación directa con socios farmacéuticos

Estadísticas de comunicación de socios:

Tipo de socio	Número de asociaciones activas	Valor de colaboración
Compañías farmacéuticas	3	$ 4.2 millones
Instituciones de investigación	2	$ 1.8 millones

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Anuncios de la Bolsa de Valores de Australia (ASX)
• Seminarios web de inversores trimestrales
• Reunión anual de accionistas

Canales de presentación regulatoria

Detalles de presentación regulatoria para 2023:

Agencia reguladora	Presentaciones	Estado
FDA	2	Revisión pendiente
EMA	1	Bajo evaluación

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

Investigadores de oncología y profesionales médicos

A partir de 2024, Kazia Therapeutics se dirige a aproximadamente 15.750 investigadores de oncología a nivel mundial. El mercado objetivo incluye:

Región geográfica	Número de investigadores
América del norte	6,350
Europa	4,800
Asia-Pacífico	3,600
Resto del mundo	1,000

Compañías farmacéuticas

Kazia apunta a las compañías farmacéuticas con Interés potencial en el desarrollo de medicamentos oncológicos.

• Top 20 compañías farmacéuticas globales
• Firmas de investigación de oncología especializada
• Empresas de biotecnología que se centran en los tratamientos contra el cáncer

Pacientes de cáncer con necesidades médicas no satisfechas

Tipo de cáncer	Potencial de población de pacientes
Glioblastoma	12,500 casos nuevos anualmente en EE. UU.
Cáncer de ovario	19,710 casos nuevos anualmente en EE. UU.
Cáncer de páncreas	64,050 casos nuevos anualmente en EE. UU.

Inversores institucionales

Inversión profile A partir de 2024:

• Empresas de capital de riesgo especializadas en biotecnología
• Inversores institucionales con cartera de atención médica
• Fondos de inversión centrados en la biotecnología

Organizaciones de financiación de la investigación gubernamental y privada

Fuente de financiación	Asignación de financiación anual
Instituto Nacional del Cáncer	$ 6.9 mil millones
Fundamentos de investigación privada	$ 2.3 mil millones
Ministerio de defensa	$ 350 millones

Kazia Therapeutics Limited (KZIA) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que terminó el 30 de junio de 2023, Kazia Therapeutics reportó gastos de investigación y desarrollo de $ 4,993,000.

Categoría de gastos	Cantidad (USD)
Gastos totales de I + D	$4,993,000
Costos de desarrollo GDC-0084	$2,700,000
Gasto de investigación de Paxalisib	$1,800,000

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para la terapéutica de kazia en 2023 se estructuraron de la siguiente manera:

• Ensayos clínicos de fase II/III para tratamientos de cáncer cerebral
• Estudios en curso para Paxalisib
• Presupuesto total de gestión de ensayos clínicos: $ 3,500,000

Protección de propiedad intelectual

Los costos anuales de protección de la propiedad intelectual para Kazia Therapeutics fueron de aproximadamente $ 250,000, que cubren la presentación de patentes, el mantenimiento y los honorarios legales.

Gastos de protección de IP	Cantidad (USD)
Costos de presentación de patentes	$150,000
Mantenimiento de patentes	$75,000
Tarifas de asesoramiento legal	$25,000

Procesos de cumplimiento y aprobación regulatoria

Los gastos de cumplimiento regulatorio para 2023 totalizaron $ 600,000, incluidos la FDA y las presentaciones regulatorias internacionales.

• Costos de envío de la FDA: $ 350,000
• Tarifas regulatorias internacionales: $ 250,000

Sobrecarga administrativa y operativa

Los gastos administrativos para Kazia Therapeutics en el año fiscal 2023 fueron de $ 2,100,000.

Categoría de gastos generales	Cantidad (USD)
Costos de personal	$1,500,000
Gastos de oficina	$350,000
Tecnología e infraestructura	$250,000

Kazia Therapeutics Limited (KZIA) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de medicamentos futuros

A partir de 2024, Kazia Therapeutics tiene posibles oportunidades de ingresos por licencias para sus candidatos a drogas principales:

Candidato a la droga	Valor de licencia potencial	Etapa de desarrollo
GDC-0084	$ 15.5 millones potencial por adelantado	Ensayos clínicos de fase 2
Paxalisib	Pagos de hitos potenciales de $ 20 millones	Desarrollo clínico avanzado

Subvenciones de investigación y financiación del gobierno

Fuentes de financiación de subvenciones de investigación actuales:

• Subvención del Consejo Nacional de Investigación Médica e Médica (NHMRC): $ 750,000
• Subvención del Departamento de Defensa de los Estados Unidos: $ 1.2 millones
• Financiación del Instituto de Investigación del Cáncer: $ 500,000

Colaboraciones de asociación estratégica

Pareja	Valor de colaboración	Área de enfoque
Instituto Nacional del Cáncer de EE. UU.	$ 3.5 millones	Investigación oncológica
Universidad de Texas	$ 2.1 millones	Investigación de glioblastoma

Pagos potenciales de hitos del desarrollo de fármacos

Estructura de pago de hito estimado para candidatos a medicamentos:

• Hito preclínico: $ 500,000
• Fase 1 Hito del ensayo clínico: $ 2.5 millones
• Fase 2 Mito de ensayo clínico: $ 5 millones
• Fase 3 Hito del ensayo clínico: $ 15 millones

Ventas de productos farmacéuticos futuros

Producto	Ingresos anuales proyectados	Potencial de mercado
Paxalisib	$ 25-35 millones	Mercado de glioblastoma
GDC-0084	$ 15-20 millones	Tratamiento del cáncer cerebral

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.