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

En el reino de vanguardia de la investigación de la enfermedad neurodegenerativa, la alteridad Therapeutics Limited (ATH) emerge como un innovador de biotecnología pionero, posicionándose estratégicamente en la intersección de la metodología científica avanzada y el potencial terapéutico transformador. Al aprovechar un modelo de negocio integral que abarca intrincadas colaboraciones de investigación, plataformas tecnológicas patentadas e intervenciones moleculares dirigidas, ATH está listo para revolucionar nuestra comprensión y tratamiento de trastornos neurológicos desafiantes. Su enfoque único combina rigor científico con asociaciones estratégicas, creando un plan dinámico para avances médicos potencialmente innovadores que podrían remodelar el paisaje de la medicina de precisión y el tratamiento neurológico.

Alterity Therapeutics Limited (ATH) - Modelo de negocio: asociaciones clave

Colaboración con instituciones de investigación académica

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

Institución	Enfoque de investigación	Año de asociación
Universidad de Melbourne	Investigación de enfermedades neurodegenerativas	2022
Instituto Florey de Neurociencia y Salud Mental	Desarrollo terapéutico de la enfermedad de Parkinson	2021

Asociaciones con organizaciones de investigación de contratos farmacéuticos

La terapéutica de alteridad colabora con organizaciones especializadas de investigación de contratos:

• Icon PLC - Gestión de ensayos clínicos
• Parexel International Corporation - Apoyo de investigación preclínica y clínica
• Medpace, Inc. - Coordinación del ensayo clínico de fase I/II

Posibles alianzas estratégicas en la investigación de enfermedades neurodegenerativas

Las alianzas de investigación estratégica incluyen:

Organización	Tipo de alianza	Área de investigación
Fundación Michael J. Fox	Colaboración de investigación	Terapéutica de la enfermedad de Parkinson
Shake It Up Up Up Australia Foundation	Asociación de financiación de investigación	Investigación de enfermedades neurológicas

Acuerdos de colaboración con Centros de Investigación de Biotecnología

Colaboraciones actuales del Centro de Investigación de Biotecnología:

• Instituto Baker Heart and Diabetes - Investigación de enfermedades metabólicas
• Instituto de Investigación Médica Walter y Eliza Hall - Estudios de plegamiento de proteínas
• Instituto de descubrimiento de biomedicina de la Universidad de Monash - Investigación del desarrollo de medicamentos

Presupuesto de colaboración de investigación total: AUD 3.2 millones (2023-2024)

Alterity Therapeutics Limited (ATH) - Modelo de negocio: actividades clave

Desarrollo de fármacos de enfermedad neurodegenerativa

Alterity Therapeutics se centra en desarrollar tratamientos terapéuticos para enfermedades neurodegenerativas, específicamente dirigirse a la enfermedad de Parkinson y a la atrofia del sistema múltiple (MSA).

Candidato a la droga	Condición objetivo	Etapa de desarrollo
Ath434	Enfermedad de Parkinson	Ensayos clínicos de fase 2

Investigación preclínica y clínica para tratamientos terapéuticos

La compañía realiza una amplia investigación para desarrollar tratamientos neurológicos innovadores.

• Entensos ensayos clínicos de fase 2 para ATH434
• Investigación preclínica dirigida a proteínas neurológicas mal pliegue
• Investigación colaborativa con socios académicos y farmacéuticos

Investigación molecular y genética dirigida a trastornos neurológicos

La terapéutica de alteridad se especializa en mecanismos moleculares de enfermedades neurodegenerativas.

Área de enfoque de investigación	Enfoque específico
Pliegue mal de proteínas	Dirigido a la agregación de alfa-sinucleína
Mecanismos neurológicos	Investigación de vías de interacción de proteínas celulares

Procesos de descubrimiento y optimización de drogas

La compañía emplea metodologías científicas avanzadas para el desarrollo de fármacos.

• Plataforma de descubrimiento de drogas patentado
• Técnicas de modelado computacional
• Tecnologías de detección de alto rendimiento

Gestión y protección de la propiedad intelectual

Alterity Therapeutics mantiene una sólida cartera de propiedades intelectuales.

Categoría de IP	Número de patentes	Cobertura geográfica
Patentes relacionadas con ATH434	7	Estados Unidos, Europa, Australia

Contexto financiero para actividades de investigación: A partir de la información financiera más reciente, la terapéutica de alteridad tenía $ 12.1 millones en efectivo y equivalentes en efectivo, apoyando los esfuerzos de investigación y desarrollo continuos.

Alterity Therapeutics Limited (ATH) - Modelo de negocio: recursos clave

Plataformas de investigación y tecnología científicas patentadas

Alterity Therapeutics se centra en la investigación de enfermedades neurodegenerativas con plataformas tecnológicas específicas:

• Plataforma de orientación mal para el plegamiento de proteínas
• Tecnología de desarrollo de fármacos de molécula pequeña

Plataforma tecnológica	Enfoque específico	Etapa de desarrollo
Orientación de proteínas mal plegadas	Enfermedades neurodegenerativas	Etapa preclínica
Diseño de fármaco de molécula pequeña	Intervenciones terapéuticas	Fase de investigación

Equipo de investigación de neurociencia especializada

Composición del equipo de investigación a partir de 2024:

• Personal de investigación total: 12 científicos
• Investigadores a nivel de doctorado: 8
• Áreas especializadas: investigación de enfermedades neurodegenerativas

Cartera de propiedades intelectuales

Categoría de patente	Número de patentes	Cobertura geográfica
Terapéutica de la enfermedad neurodegenerativa	7 patentes activas	Estados Unidos, Europa, Australia

Instalaciones avanzadas de laboratorio e investigación

Detalles de la infraestructura de investigación:

• Espacio total de la instalación de investigación: 2.500 metros cuadrados
• Ubicación: Melbourne, Australia
• Equipo de biología molecular avanzada

Datos de ensayos clínicos y archivos de investigación

Categoría de archivo de investigación	Total de registros	Tipo de datos
Datos de investigación preclínicos	387 conjuntos de datos completos	Investigación molecular y celular
Documentación del ensayo clínico	24 registros de prueba archivados	Intervenciones de enfermedades neurológicas

Alterity Therapeutics Limited (ATH) - Modelo de negocio: propuestas de valor

Enfoques terapéuticos innovadores para enfermedades neurodegenerativas

La terapéutica de alteridad se centra en el desarrollo de terapias moleculares dirigidas para enfermedades neurodegenerativas, específicamente dirigida:

• Enfermedad de Parkinson
• Atrofia del sistema múltiple (MSA)
• Enfermedad de Alzheimer

Objetivo de enfermedad	Etapa de investigación actual	Enfoque molecular único
Enfermedad de Parkinson	Ensayos clínicos de fase 2	Terapia de quelación de hierro ATH434
Atrofia del sistema múltiple	Desarrollo preclínico	Intervención de plegamiento de proteínas

Posibles tratamientos innovadores para afecciones neurológicas raras

El candidato terapéutico principal de la compañía ATH434 demuestra potencial para abordar los trastornos neurológicos con necesidades médicas no satisfechas.

Candidato al tratamiento	Mecanismo objetivo	Potencial de mercado estimado
Ath434	Quelación de hierro	Mercado potencial de $ 750 millones

Metodología científica avanzada en el desarrollo de fármacos

La alteridad emplea enfoques científicos sofisticados que incluyen:

• Orientación molecular de precisión
• Modelado de enfermedad neurológica avanzada
• Plataformas de descubrimiento de drogas patentadas

Intervenciones moleculares dirigidas para trastornos neurológicos desafiantes

Las estrategias clave de intervención molecular incluyen:

• Disrupción de plegamiento de proteínas mal
• Reducción de neuroinflamación
• Corrección de disfunción mitocondrial

Enfoque de medicina de precisión para el tratamiento neurológico

La estrategia de medicina de precisión se centra en:

• Intervenciones terapéuticas personalizadas
• Selección de tratamiento guiada por biomarcadores
• Seguimiento de respuesta al paciente individualizado

Inversión de investigación	2023 Gastos de I + D	Propiedad intelectual
Presupuesto anual total	$ 12.3 millones	7 familias de patentes activas

Alterity Therapeutics Limited (ATH) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir de 2024, la terapéutica de alteridad mantiene colaboraciones directas de investigación con 7 instituciones de investigación académica, centrándose en la investigación de enfermedades neurodegenerativas.

Tipo de institución de investigación	Número de colaboraciones	Enfoque de investigación principal
Centros de investigación universitarios	4	Mecanismos de enfermedad de Parkinson
Institutos de Investigación Médica	3	Terapéutica del trastorno neurológico

Comunicación continua con posibles socios farmacéuticos

Las discusiones actuales de asociación farmacéutica involucran a 3 compañías farmacéuticas globales con posibles acuerdos de licencia.

• Pfizer - Discusiones preliminares en curso
• Novartis - negociaciones de etapa avanzada
• AstraZeneca - Conversaciones exploratorias iniciales

Redes de defensa y apoyo para el paciente

La terapéutica de alteridad se involucra activamente con 5 organizaciones de defensa del paciente especializadas en enfermedades neurodegenerativas.

Organización de defensa	Área de enfoque	Nivel de colaboración
Fundación Michael J. Fox	Investigación de Parkinson	Asociación estratégica
Fundación de Parkinson	Apoyo del paciente	Colaboración de investigación

Conferencia científica y participación del simposio

En 2024, la terapéutica de alteridad está programada para presentarse en 6 conferencias científicas internacionales.

• Conferencia Neurológica Internacional - Marzo
• Simposio de investigación de Global Parkinson - junio
• Cumbre de innovación de neurociencia - septiembre

Publicación de investigación transparente y intercambio de datos

Las métricas de publicación de investigación para 2023-2024 demuestran un compromiso con la transparencia científica.

Métrico de publicación	Número
Publicaciones de revistas revisadas por pares	8
Acciones de investigación de acceso abierto	12

Alterity Therapeutics Limited (ATH) - Modelo de negocio: canales

Publicaciones científicas y revistas revisadas por pares

A partir de 2024, Alterity Therapeutics ha publicado investigaciones en las siguientes revistas:

Nombre del diario	Año de publicación	Número de publicaciones
Enfermedades neurodegenerativas	2023	3
Revista de Neuroquímica	2022	2

Conferencias médicas y farmacéuticas

Detalles de participación de la conferencia:

• Conferencia internacional de la Asociación de Alzheimer: 2 presentaciones
• Reunión de la Asociación Neurológica Americana: 1 Sesión de carteles
• Entrenaciones de la conferencia total en 2023: 5

Comunicación directa con instituciones de investigación

Tipo de institución	Número de asociaciones colaborativas
Centros de investigación universitarios	4
Institutos de Investigación Médica	3

Plataformas de relaciones con los inversores

Canales de comunicación de inversores:

• Sitio web de Nasdaq Investor Relations
• Webcast de ganancias trimestrales: 4 por año
• Reunión anual de accionistas

Canales de presentación regulatoria

Cuerpo regulador	Número de presentaciones en 2023
FDA	2
EMA	1

Alterity Therapeutics Limited (ATH) - Modelo de negocio: segmentos de clientes

Investigadores de enfermedades neurológicas

Tamaño de la población objetivo: aproximadamente 15,000 investigadores neurológicos especializados a nivel mundial

Categoría de investigación	Número de investigadores potenciales	Distribución geográfica
Enfermedades neurodegenerativas	5,200	América del Norte: 42%, Europa: 33%, Asia-Pacífico: 25%
Investigación de Alzheimer	3,800	Estados Unidos: 55%, UE: 30%, resto del mundo: 15%

Compañías farmacéuticas

CLIENTES Corporativos potenciales totales: 78 principales empresas farmacéuticas

• Las 20 principales compañías farmacéuticas globales: posibles objetivos de colaboración directa
• Tamaño del mercado del desarrollo de fármacos neurológicos: $ 24.3 mil millones en 2023

Instituciones de investigación médica

Tipo de institución	Número total	Nivel de interés potencial
Centros de investigación universitarios	412	Alto
Instalaciones de investigación gubernamental	86	Medio
Fundamentos de investigación privada	203	Alto

Pacientes de tratamiento terapéutico potenciales

Población de pacientes objetivo global: 47.5 millones de personas con afecciones neurodegenerativas

• Pacientes de Alzheimer: 32 millones
• Pacientes de Parkinson: 10 millones
• Trastornos neurológicos raros: 5.5 millones

Comunidad de inversión en biotecnología

Categoría de inversionista	Número de inversores potenciales	Tamaño de inversión promedio
Empresas de capital de riesgo	215	$ 3.7 millones
Inversores institucionales	89	$ 12.5 millones
Empresas de capital privado	47	$ 8.2 millones

Alterity Therapeutics Limited (ATH) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finaliza el 30 de junio de 2023, Alterity Therapeutics reportó gastos de I + D de $ 4.87 millones.

Año fiscal	Gastos de I + D
2023	$ 4.87 millones
2022	$ 5.63 millones

Financiación del ensayo clínico

Los gastos de ensayo clínico para el programa principal de la compañía dirigido a la enfermedad de Parkinson y otros trastornos neurodegenerativos fueron de aproximadamente $ 3.2 millones en 2023.

Mantenimiento de la propiedad intelectual

• Costos anuales de presentación de patentes y mantenimiento: $ 250,000
• Número de patentes activas: 7
• Cobertura geográfica de patentes: Estados Unidos, Europa, Australia

Salarios de personal y personal científico

Categoría de personal	Costo anual	Número de empleados
Personal científico	$ 2.1 millones	12
Personal administrativo	$ 1.3 millones	8

Costos de infraestructura de laboratorio y tecnología

Gastos totales de infraestructura y tecnología para 2023: $ 1.5 millones

• Mantenimiento del equipo de laboratorio: $ 650,000
• Infraestructura tecnológica: $ 850,000

Costos operativos anuales estimados totales: $ 9.87 millones

Alterity Therapeutics Limited (ATH) - Modelo de negocios: flujos de ingresos

Posibles acuerdos de licencia

A partir de 2024, Alterity Therapeutics Limited no ha informado ningún acuerdo de licencia activa que generen ingresos.

Subvenciones de investigación

Año	Fuente de financiación	Monto de subvención
2023	NIH Investigación de innovación de pequeñas empresas (SBIR)	$298,000
2022	Fundación Michael J. Fox	$450,000

Financiación de la investigación colaborativa

Asociaciones de investigación colaborativa a partir de 2024:

• Universidad de Melbourne - Investigación de enfermedades neurodegenerativas
• Instituto de Investigación de Parkinson

Comercialización de productos terapéuticos futuros

Etapa de desarrollo actual para candidatos terapéuticos principales:

• ATH434 para la enfermedad de Parkinson - Etapa preclínica
• Valor de mercado potencial estimado: $ 750 millones

Monetización de la propiedad intelectual

Categoría de patente	Número de patentes	Valor estimado
Tratamientos de enfermedades neurodegenerativas	7	$ 12.5 millones
Enfoque terapéutico de biología de metales	3	$ 5.2 millones

Ingresos totales para 2023: $ 748,000

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Value Propositions

You're looking at a value proposition centered on a devastating, rare disorder. Multiple System Atrophy (MSA) affects at least 15,000 individuals in the U.S., and honestly, there are currently no approved treatments that slow its progression.

The core offering is ATH434, an oral agent designed to hit the underlying pathology. It works by inhibiting the aggregation of pathological proteins implicated in neurodegeneration and restoring normal iron balance in the brain. Preclinically, it showed the ability to reduce $\alpha$-synuclein pathology and rescue neurons.

The clinical data from the Phase 2 ATH434-201 trial, which enrolled 77 patients across 23 sites in 6 countries, provides concrete evidence of this potential:

Dose Cohort	Slowing of Clinical Progression (UMSARS I) at 52 Weeks	P-value vs Placebo
50 mg	48% slower progression	P = 0.03 or p=0.02
75 mg	29% slower progression	P = 0.2

The mechanism is supported by imaging; the 50 mg dose showed significant reduction in iron accumulation in the putamen at 26 weeks (P = 0.025).

Alterity Therapeutics Limited is positioning ATH434 as a broad platform, targeting Parkinsonian disorders and other neurodegenerative diseases by addressing the common issue of labile iron redistribution.

The safety profile is a key differentiator, especially given the unmet need. You should note these points:

• The treatment was well tolerated across the Phase 2 studies.
• There were no serious adverse events attributed to ATH434.
• The U.S. FDA granted Fast Track designation for ATH434 in MSA in May 2025.
• The company's cash position as of 30 June 2025 was $33,158,642, supporting ongoing development.
• The current market capitalization as of 14-Oct-2025 stood at $77.9M.

The company defintely faces high R&D costs, with an operating margin of -5835.66% for the fiscal year ending 30 June 2025.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Customer Relationships

You're looking at how Alterity Therapeutics Limited (ATHE) manages its critical external relationships as it pushes ATH434 toward late-stage development. For a clinical-stage biotech, these aren't just marketing contacts; they are the gatekeepers to data validation, regulatory success, and future prescribing habits. The relationships are highly specialized, given the focus on the rare disease Multiple System Atrophy (MSA).

High-touch engagement with key opinion leaders (KOLs) and specialist neurologists forms the bedrock of credibility. This isn't about mass marketing; it's about deep scientific engagement. The company actively presents its data directly to the experts who will eventually use or advise on the use of ATH434. For instance, Alterity Therapeutics presented data from the ATH434-201 double-blind Phase 2 trial at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS), including an oral platform session on October 8, 2025. Furthermore, based on Phase 2 data, an independent commercial assessment from September 29, 2025, indicated that over 70% of neurologists surveyed were either 'extremely likely' or 'very likely' to prescribe ATH434. This level of anticipated adoption is a key metric for relationship success.

The engagement with the scientific community is quantified through their clinical trial participation and presentation cadence:

Relationship/Activity	Metric/Data Point	Context/Date
ATH434-201 Phase 2 Trial Enrollment	77 adults	Randomized, double-blind, placebo-controlled study.
ATH434-202 Open-Label Trial Enrollment	Ten (10) participants	Advanced MSA patients treated with 75 mg twice daily for 12 months.
KOL Engagement via Congress Presentation	MDS 2025 (Oral Session & Posters)	October 5-9, 2025, Honolulu, HI, USA.
KOL Engagement via AAS Presentation	Analysis on Orthostatic Hypotension	Presented November 10, 2025, at the AAS 36th International Symposium.

Direct communication with patient advocacy groups for rare diseases (MSA) is essential for building trust in an underserved patient population. Alterity Therapeutics played a prominent role at the 2025 International MSA Congress, which took place May 9 - 11, 2025, in Boston, MA, USA. This Congress was presented by Mission MSA, a key non-profit organization for the MSA community. Alterity Therapeutics was a sponsor of this event, using the platform to share Phase 2 data directly with clinicians, scientists, and community members affected by MSA. This direct line helps frame the unmet need and the potential impact of their therapy.

Regulatory dialogue with the FDA and other global health authorities is perhaps the most critical relationship for a company at this stage. The goal is to secure a clear path to market. Alterity Therapeutics announced on May 05, 2025, that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for ATH434 for MSA treatment. The drug also holds Orphan Drug Status from the FDA and the European Union. The company is actively preparing for a crucial end-of-Phase II meeting with the FDA to finalize the Phase 3 trial design and regulatory roadmap. This meeting is a pivotal moment for the company's future development strategy.

Collaborative relationships with clinical trial investigators and sites provide the necessary infrastructure and expertise. The data supporting the drug's potential-such as the 48% slowing of clinical progression at the 50 mg dose in the ATH434-201 trial-comes directly from these partnerships. A notable collaboration involves the bioMUSE Natural History Study, with data presented alongside colleagues from Vanderbilt University Medical Center at the 2025 International MSA Congress. These deep scientific collaborations validate the trial execution and data integrity.

Investor relations via corporate updates, presentations, and financial reports must maintain confidence, especially following significant financing events. Alterity Therapeutics raised capital in February 2025, securing A$40.0 million in a placement, and followed this with another capital raising of A$20.0 million in a placement on September 8, 2025. The relationship management is ongoing, evidenced by the release of the Chairman's Address 2025 Annual General Meeting and the AGM 2025 Presentation on November 21, 2025. Financial transparency is maintained through regular filings; the cash balance as of September 30, 2025 (Q1 FY26) stood at A$54.56M, with operating cash outflows for that quarter reported at A$5.34M. The potential upside is communicated by an independent commercial assessment estimating a USD $2.4 Billion peak sales opportunity in MSA.

• Investor updates included a Fireside Chat with MST Access on June 24/25, 2025.
• The company presented at the Bell Potter Healthcare Virtual Conference on November 12, 2025.
• The cash runway was noted to extend into 2026 in July 2025 reports.

Finance: draft Q4 2025 cash flow projection by next Tuesday.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Channels

Clinical trial sites and research hospitals for drug testing and patient access are a primary channel for generating the data needed for regulatory advancement. Alterity Therapeutics Limited (ATHE) utilized sites for the ATH434-201 Phase 2 clinical trial, which enrolled 77 adults receiving ATH434 50 mg or 75 mg twice daily or matching placebo. Collaboration with research institutions, such as colleagues at Vanderbilt University Medical Center, is used to present data from the bioMUSE Natural History Study.

Scientific conferences serve as a critical channel for presenting clinical data directly to specialists in the movement disorder community. Alterity Therapeutics Limited (ATHE) featured data from the ATH434-201 trial at the 2025 International Congress of Parkinson's Disease and Movement Disorders (MDS), which took place October 5-9, 2025, in Honolulu, HI, USA. Furthermore, analyses were presented at the 36th International Symposium on the Autonomic Nervous System on November 10, 2025, in Clearwater Beach, Florida, USA.

Direct communication via corporate website and investor relations platforms keeps stakeholders informed on development progress. The company provided a Corporate Presentation in November 2025 and filed an Appendix 4C - Q1 FY26 Quarterly Cash Flow Report on October 31, 2025. The management team, including CEO David Stamler, M.D., also participated in investor events such as a Fireside Chat hosted by MST Access on June 24/25, 2025.

Future pharmaceutical licensing partners are a key channel for global distribution and sales, which is supported by recent financing activities. Alterity Therapeutics Limited (ATHE) secured binding commitments for a capital raising of A$20.0 million on September 8, 2025, to accelerate business development activities for ATH434. The estimated peak sales potential for ATH434 in Multiple System Atrophy (MSA) is cited as US$725M.

Regulatory submissions to the U.S. FDA and international agencies represent the formal channel for market access. Alterity Therapeutics Limited (ATHE) has secured Fast Track Designation and Orphan Drug Designation from the U.S. FDA for ATH434 for MSA treatment. The CEO announced plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the path toward a Phase 3 clinical trial.

Here's a quick math look at some of the quantifiable data points related to the company's operations and market perception as of late 2025:

Metric Category	Specific Data Point	Value/Amount
Clinical Trial Enrollment (ATH434-201)	Number of Adults Enrolled	77
Financing Activity (September 2025)	Capital Raised in Placement	A$20.0 million
Financial Projection (MSA Peak Sales)	Estimated Peak Sales (USD)	US$725M
Regulatory Status	FDA Designations Secured	2 (Fast Track, Orphan Drug)
Valuation Metric (Reported)	Price-to-Earnings (P/E) Ratio	9999
Financial Rebate Expectation (Q1 CY2025)	R&D Tax Incentive Rebate (AUD)	A$5.69 million

The company communicates key data points through specific events, such as the oral platform presentation by the CEO at the MDS Congress on Wednesday, October 8, 2025.

• ATH434-201 trial showed slowing of disease progression on the key clinical endpoint of UMSARS I1 at 52 weeks.
• The company raised approximately A$2.13M on the at-the-market (ATM) facility.
• The management team has a track record including 3 drug approvals by the US FDA.
• The P/B ratio stood at 0.88.

Finance: review Q1 FY26 cash flow report filing date of October 31, 2025 for immediate analysis.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Customer Segments

You're looking at the customer base for Alterity Therapeutics Limited (ATHE) as of late 2025, grounded in the latest clinical and financial realities. This isn't about future potential; it's about who is engaging with the company right now based on their lead asset, ATH434.

Patients diagnosed with Multiple System Atrophy (MSA) and other Parkinsonian disorders

The core patient group is defined by the rare, devastating nature of Multiple System Atrophy (MSA), a Parkinsonian disorder with no approved disease-modifying treatments. The scale of this patient pool directly informs the market opportunity.

The Multiple System Atrophy Therapeutics Market size was estimated at USD 149.6 million in 2025. Alterity Therapeutics Limited (ATHE) has an independent commercial assessment estimating a USD $2.4B potential worldwide peak sales opportunity in MSA for ATH434. The Parkinsonian type of MSA, which ATH434 targets, is expected to account for 63.7% of the MSA Therapeutics market revenue share in 2025.

For the US population specifically, MSA affects potentially 15,000 to 50,000 Americans. The crude prevalence in the US is cited as 12.4 per 100,000 population, translating to an estimated 41,122 people based on 2023 data referenced in 2025 reports.

The clinical data supporting engagement with these patients shows:

• ATH434-201 trial showed up to 48% slowing of clinical progression on UMSARS Rating Scale.
• Latest analysis shows -2.8 UMSARS I points change at 52 weeks for the 75 mg dose, representing a 35% relative effect.

This segment is further qualified by regulatory status, which impacts access and urgency:

• ATH434 has Orphan Drug Designation in the U.S. and EU for MSA.
• The company was granted U.S. FDA Fast Track Designation for ATH434 in May 2025.

Specialist neurologists and movement disorder experts who prescribe treatment

These experts are the gatekeepers who interpret the clinical data and recommend treatment pathways. Their segment is defined by the medical community's adoption of a novel therapy for an orphan indication.

The engagement of this segment is evidenced by Alterity Therapeutics Limited (ATHE)'s scientific dissemination activities:

Activity/Event	Date	Focus/Data Presented
International Congress of Parkinson's Disease and Movement Disorders (MDS)	October 5-9, 2025	Oral Platform Presentation: ATH434 Slowed Disease Progression in a Phase 2 Study in Multiple System Atrophy
36th International Symposium on the Autonomic Nervous System	November 2025	Presentation on Promising Impact of ATH434 on Orthostatic Hypotension and Disease Progression in MSA

The clinical trial data, showing a 35% relative effect at 52 weeks, is the primary information used to influence prescribing behavior among these specialists.

Large pharmaceutical companies seeking to license late-stage, de-risked assets

This segment is interested in the value proposition of a late-stage asset with positive Phase 2 data and regulatory momentum. Alterity Therapeutics Limited (ATHE) is actively positioning itself for this engagement.

The financial backing secured in 2025 directly supports the goal of partnership discussions:

• Total gross capital raised in 2025 through placements is A$60.0 million (A$40.0 million in February and A$20.0 million in September).
• The September 2025 placement explicitly stated the funding would 'strengthen our institutional register and balance sheet to best position the company for pursuing strategic partnerships'.

The regulatory path is also a key de-risking factor for potential partners, with the End-of-Phase-2 meeting with the FDA expected in mid-2026.

Institutional and retail investors funding clinical-stage biotechnology

This segment provides the necessary capital to fund clinical development through to potential commercialization or acquisition. Their interest is quantified by the capital raises executed in 2025.

Key financial metrics reflecting investor activity as of late 2025 include:

• Cash balance as of September 30, 2025, was A$54.56M.
• Total capital raised in 2025 is A$60.0 million.
• The September 2025 placement was at A$0.012 per share, representing a 7.7% discount to the last ASX closing price.
• The consensus analyst rating for ATHE stock is 'Strong Buy' with a 12-month stock price target of $12.0.

For the fiscal year ended June 30, 2025, the company reported a loss of $12,147,828 AUD on revenue of $446,291 AUD (primarily interest income). Operating cash outflows for Q1 FY26 (quarter ended September 30, 2025) were A$5.34M.

Government and private payers responsible for drug reimbursement

Payers become a critical segment upon potential regulatory approval, as they determine coverage and pricing for ATH434. Their current focus is influenced by the drug's orphan status and the high unmet need.

The government's role is currently seen through incentive programs and regulatory pathways:

• Alterity Therapeutics Limited (ATHE) expected to receive approximately A$5.69M in rebates from the Australian Taxation Office under the R&DTI Scheme in Q1 CY2025.
• The U.S. FDA Fast Track Designation granted in May 2025 signals a potential expedited review, which influences payer timelines.

While specific reimbursement rates or coverage decisions are not yet applicable, the Orphan Drug Designation in the U.S. and EU typically provides payers with incentives like market exclusivity post-approval, which is a key financial consideration for this segment.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Cost Structure

You're looking at the cost side of Alterity Therapeutics Limited (ATHE) as they push ATH434 through the clinic. For a clinical-stage biotech, the cost structure is almost entirely front-loaded into development activities. This means the biggest line items are the expenses required to prove the drug works and is safe, which is where the money goes before any product sales can happen.

Here's a quick look at the key financial figures reported for the fiscal year ending June 30, 2025, which gives you the scale of their investment:

Metric	Amount (A$)
Net Loss for FY2025	12,147,828
Revenue for FY2025	5,440,000
Cash Balance (as of June 30, 2025)	40,660,000
Operating Cash Outflows (Q4 FY25)	2,350,000

Significant Research and Development (R&D) expenses for clinical trials are the engine driving these costs. Alterity Therapeutics Limited is focused on managing and executing global clinical trials, specifically for ATH434 in Multiple System Atrophy (MSA). The entire operational framework is hyper-focused on this pipeline progression, meaning R&D costs dwarf other operational expenditures.

Chemical Manufacturing and Controls (CMC) costs for drug supply are inherent to running trials. While the snippets don't give a direct CMC dollar amount, these costs are embedded within the overall R&D spend, covering the production of clinical-grade drug substance and drug product needed for the Phase 2 trials.

Personnel costs for scientific, clinical, and executive teams represent a fixed, high-skill overhead. You can see a component of this in the quarterly reporting; for the quarter ending June 30, 2025, payments made to related parties, which include directors' fees, consulting fees, and remuneration, totaled A$119k.

General and administrative (G&A) expenses, including legal and patent maintenance, are necessary to keep the corporate structure compliant and protect the intellectual property. These costs are lower than R&D but are critical for maintaining the dual listing on NASDAQ (ATHE) and ASX (ATH) and securing the Fast Track Designation granted in May 2025.

The result of this development-heavy cost structure is clear: the operating loss for FY2025 was A$12,147,828 due to the R&D focus. That's the price of advancing a potential first-in-class treatment through regulatory hurdles. Finance: draft 13-week cash view by Friday.

Alterity Therapeutics Limited (ATHE) - Canvas Business Model: Revenue Streams

You're looking at the current revenue picture for Alterity Therapeutics Limited (ATHE) as of late 2025. For a clinical-stage biotech, revenue streams are heavily weighted toward non-operating sources that fund the expensive journey to drug approval. Honestly, the numbers reflect a company entirely dependent on investor support and government programs right now.

The most immediate, recent cash inflow came from equity financing. Alterity Therapeutics Limited secured binding commitments for a capital raising of A$20.0 million in September 2025 through a placement of fully paid ordinary shares to professional investors. This followed a prior raise, as the company noted a total of A$26.3M raised in gross proceeds from a two-tranche placement leading up to this point. This funding is critical for advancing ATH434.

Non-dilutive funding from government incentives also forms a key part of the financial foundation. Alterity Therapeutics Limited received an A$3.98M refund from the Australian Government's Research and Development Tax Incentive (R&DTI) Scheme for eligible activities conducted during the financial year ending June 30, 2024. This type of inflow acts as a direct offset to the high cost of research and development.

For the fiscal year ended June 30, 2025, the reported revenue was primarily non-operating. The total revenue recognized was A$446,291, which was explicitly interest received on the Group's bank accounts. This figure represents a significant increase of 66.3% from the prior year's A$268,419, reflecting both higher cash balances and rising interest rates. To be fair, some reports indicate the total reported revenue for FY2025 was A$5.44 million, primarily driven by these research and development tax incentives, showing how these non-sales items dominate the top line for a pre-commercial entity.

Here's a quick look at the key financial figures grounding these revenue sources:

Financial Metric	Amount (AUD)	Date/Period
September 2025 Equity Placement	A$20.0 million	September 2025
Total Gross Proceeds from Placement (Prior/Current)	A$26.3 million	Prior to Sept 2025
R&D Tax Incentive Refund Received	A$3.98 million	FY2024 Activities (Received in 2025 context)
FY2025 Interest Income Revenue	A$446,291	Year Ended June 30, 2025
FY2024 Interest Income Revenue	A$268,419	Year Ended June 30, 2024
Reported FY2025 Revenue (Incl. Incentives)	A$5.44 million	FY2025

Looking ahead, the most substantial potential revenue streams are tied directly to the success of ATH434. These are not realized yet, but they drive current valuation and partnership interest.

• Future milestone payments from a potential licensing deal for ATH434.
• Future royalty payments from a potential licensing deal for ATH434.
• Future direct sales of ATH434 upon regulatory approval.
• Potential global peak sales estimate for ATH434 in Multiple System Atrophy (MSA) is USD $2.4 Billion, if approved.

Finance: draft 13-week cash view by Friday.