Alterity Therapeutics Limited (ATHTH): Modelo de negócios Canvas [Jan-2025 Atualizado]

No domínio de ponta da pesquisa de doenças neurodegenerativas, a Alterity Therapeutics Limited (ATHE) surge como um inovador pioneiro de biotecnologia, posicionando-se estrategicamente na interseção da metodologia científica avançada e do potencial terapêutico transformador. Ao alavancar um modelo de negócios abrangente que abrange colaborações intrincadas de pesquisa, plataformas de tecnologia proprietárias e intervenções moleculares direcionadas, o Athe está pronto para revolucionar nosso entendimento e tratamento de desafios neurológicos desafiadores. Sua abordagem única combina rigor científico com parcerias estratégicas, criando um plano dinâmico para avanços médicos potencialmente inovadores que poderiam remodelar o cenário da medicina de precisão e tratamento neurológico.

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa acadêmica

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

Instituição	Foco na pesquisa	Ano de parceria
Universidade de Melbourne	Pesquisa de doenças neurodegenerativas	2022
Instituto Florey de Neurociência e Saúde Mental	Desenvolvimento terapêutico da doença de Parkinson	2021

Parcerias com organizações de pesquisa de contratos farmacêuticos

A Alterity Therapeutics colabora com organizações especializadas de pesquisa de contratos:

• Icon PLC - Gerenciamento de ensaios clínicos
• Parexel International Corporation - Apoio à pesquisa pré -clínica e clínica
• Medpace, Inc. - Coordenação do ensaio clínico Fase I/II

Potenciais alianças estratégicas na pesquisa de doenças neurodegenerativas

As alianças de pesquisa estratégica incluem:

Organização	Tipo de aliança	Área de pesquisa
Michael J. Fox Foundation	Colaboração de pesquisa	Terapêutica da doença de Parkinson
Shake It Up Australia Foundation	Pesquisa Parceria de financiamento	Pesquisa em doenças neurológicas

Acordos colaborativos com centros de pesquisa de biotecnologia

Colaborações atuais do Centro de Pesquisa de Biotecnologia:

• Instituto de Coração e Diabetes Baker - Pesquisa de Doenças Metabólicas
• Walter e Eliza Hall Instituto de Pesquisa Médica - Estudos de Maldição de Proteínas
• Monash University Biomedicine Discovery Institute - Pesquisa de Desenvolvimento de Medicamentos

Orçamento total de colaboração de pesquisa: AUD 3,2 milhões (2023-2024)

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: Atividades -chave

Desenvolvimento de medicamentos para doenças neurodegenerativas

A alteridade terapêutica se concentra no desenvolvimento de tratamentos terapêuticos para doenças neurodegenerativas, direcionando especificamente a doença de Parkinson e a atrofia do sistema múltiplo (MSA).

Candidato a drogas	Condição alvo	Estágio de desenvolvimento
ATH434	Doença de Parkinson	Ensaios clínicos de fase 2

Pesquisa pré -clínica e clínica para tratamentos terapêuticos

A empresa realiza uma extensa pesquisa para desenvolver tratamentos neurológicos inovadores.

• Ensaios clínicos de fase 2 em andamento para ATH434
• Pesquisa pré -clínica direcionada a desdobramento de proteínas neurológicas
• Pesquisa colaborativa com parceiros acadêmicos e farmacêuticos

Pesquisa molecular e genética direcionando distúrbios neurológicos

A Alterity Therapeutics é especializada em mecanismos moleculares de doenças neurodegenerativas.

Área de foco de pesquisa	Abordagem específica
Dobramento de proteínas	Direcionando a agregação de alfa-sinucleína
Mecanismos neurológicos	Investigando as vias de interação da proteína celular

Processos de descoberta e otimização de medicamentos

A empresa emprega metodologias científicas avançadas para o desenvolvimento de medicamentos.

• Plataforma proprietária de descoberta de medicamentos
• Técnicas de modelagem computacional
• Tecnologias de triagem de alto rendimento

Gerenciamento de propriedade intelectual e proteção

A Alterity Therapeutics mantém um portfólio de propriedade intelectual robusta.

Categoria IP	Número de patentes	Cobertura geográfica
ATH434 Patentes relacionadas	7	Estados Unidos, Europa, Austrália

Contexto financeiro para atividades de pesquisa: A partir dos relatórios financeiros mais recentes, a Alterity Therapeutics tinha US $ 12,1 milhões em dinheiro e equivalentes de caixa, apoiando os esforços contínuos de pesquisa e desenvolvimento.

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: Recursos -chave

Plataformas de pesquisa científica e tecnologia proprietárias

A Alterity Therapeutics se concentra na pesquisa de doenças neurodegenerativas com plataformas tecnológicas específicas:

• Plataforma de segmentação de dobramento de proteínas
• Tecnologia de desenvolvimento de medicamentos para pequenas moléculas

Plataforma de tecnologia	Foco específico	Estágio de desenvolvimento
Direcionamento de proteínas dobradas	Doenças neurodegenerativas	Estágio pré-clínico
Projeto de medicamento de pequenas moléculas	Intervenções terapêuticas	Fase de pesquisa

Equipe especializada de pesquisa de neurociência

Composição da equipe de pesquisa em 2024:

• Pessoal de pesquisa total: 12 cientistas
• Pesquisadores de nível de doutorado: 8
• Áreas especializadas: pesquisa neurodegenerativa de doenças

Portfólio de propriedade intelectual

Categoria de patentes	Número de patentes	Cobertura geográfica
Terapêutica da doença neurodegenerativa	7 patentes ativas	Estados Unidos, Europa, Austrália

Instalações avançadas de laboratório e pesquisa

Detalhes da infraestrutura de pesquisa:

• Espaço total da instalação de pesquisa: 2.500 metros quadrados
• Localização: Melbourne, Austrália
• Equipamento avançado de biologia molecular

Dados de ensaios clínicos e arquivos de pesquisa

Categoria de Arquivo de Pesquisa	Total de registros	Tipo de dados
Dados de pesquisa pré -clínica	387 conjuntos de dados abrangentes	Pesquisa molecular e celular
Documentação do ensaio clínico	24 registros de teste arquivados	Intervenções neurológicas de doenças

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: proposições de valor

Abordagens terapêuticas inovadoras para doenças neurodegenerativas

A alteridade terapêutica se concentra no desenvolvimento de terapias moleculares direcionadas para doenças neurodegenerativas, direcionando -se especificamente:

• Doença de Parkinson
• Atrofia do sistema múltiplo (MSA)
• Doença de Alzheimer

Alvo de doença	Estágio de pesquisa atual	Abordagem molecular única
Doença de Parkinson	Ensaios clínicos de fase 2	Terapia de quelação de ferro ATH434
Atrofia do sistema múltiplo	Desenvolvimento pré -clínico	Intervenção incorreta de proteínas

Possíveis tratamentos inovadores para condições neurológicas raras

O candidato terapêutico da empresa ATH434 demonstra potencial para atender aos distúrbios neurológicos com necessidades médicas não atendidas.

Candidato a tratamento	Mecanismo de destino	Potencial estimado de mercado
ATH434	Quelação de ferro	Mercado potencial de US $ 750 milhões

Metodologia científica avançada no desenvolvimento de medicamentos

A alteridade emprega abordagens científicas sofisticadas, incluindo:

• Direcionamento molecular de precisão
• Modelagem avançada de doenças neurológicas
• Plataformas proprietárias de descoberta de medicamentos

Intervenções moleculares direcionadas para desafiar distúrbios neurológicos

As principais estratégias de intervenção molecular incluem:

• Interrupção incorreta de proteínas
• Redução de neuroinflamação
• Correção da disfunção mitocondrial

Abordagem de medicina de precisão para tratamento neurológico

A estratégia de medicina de precisão se concentra:

• Intervenções terapêuticas personalizadas
• Seleção de tratamento guiada por biomarcadores
• Rastreamento de resposta do paciente individualizado

Investimento em pesquisa	2023 Despesas de P&D	Propriedade intelectual
Orçamento anual total	US $ 12,3 milhões	7 famílias de patentes ativas

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com a comunidade de pesquisa médica

A partir de 2024, a Alterity Therapeutics mantém colaborações diretas de pesquisa com 7 instituições de pesquisa acadêmica, com foco na pesquisa de doenças neurodegenerativas.

Tipo de instituição de pesquisa	Número de colaborações	Foco de pesquisa primária
Centros de Pesquisa Universitária	4	Mecanismos da doença de Parkinson
Institutos de pesquisa médica	3	Terapêutica de Transtorno Neurológico

Comunicação contínua com potenciais parceiros farmacêuticos

As discussões atuais de parceria farmacêutica envolvem três empresas farmacêuticas globais com possíveis acordos de licenciamento.

• Pfizer - discussões preliminares em andamento
• Novartis - Negociações de estágio avançado
• AstraZeneca - Conversas exploratórias iniciais

Advocacia de pacientes e redes de suporte

A terapêutica de alteridade se envolve ativamente com 5 organizações de defesa de pacientes especializadas em doenças neurodegenerativas.

Organização de Advocacia	Área de foco	Nível de colaboração
Michael J. Fox Foundation	Pesquisa de Parkinson	Parceria estratégica
Fundação de Parkinson	Suporte ao paciente	Colaboração de pesquisa

Conferência Científica e Participação do Simpósio

Em 2024, a Alterity Therapeutics está programada para se apresentar em 6 conferências científicas internacionais.

• Conferência Neurológica Internacional - Março
• Simpósio de Pesquisa Global Parkinson - junho
• Cúpula de Inovação em Neurociência - Setembro

Publicação de pesquisa transparente e compartilhamento de dados

As métricas de publicação de pesquisa para 2023-2024 demonstram compromisso com a transparência científica.

Métrica de publicação	Número
Publicações de revistas revisadas por pares	8
Ações de pesquisa de acesso aberto	12

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: canais

Publicações científicas e revistas revisadas por pares

A partir de 2024, a Alterity Therapeutics publicou pesquisas nos seguintes periódicos:

Nome do diário	Ano de publicação	Número de publicações
Doenças neurodegenerativas	2023	3
Jornal de Neuroquímica	2022	2

Conferências médicas e farmacêuticas

Detalhes da participação na conferência:

• Conferência Internacional da Associação de Alzheimer: 2 apresentações
• Reunião da Associação Neurológica Americana: 1 sessão de pôsteres
• Total de compromissos da conferência em 2023: 5

Comunicação direta com instituições de pesquisa

Tipo de instituição	Número de parcerias colaborativas
Centros de Pesquisa Universitária	4
Institutos de pesquisa médica	3

Plataformas de relações com investidores

Canais de comunicação de investidores:

• Site de relações com investidores da NASDAQ
• Webcast trimestral de ganhos: 4 por ano
• Reunião Anual dos Acionistas

Canais de submissão regulatórios

Órgão regulatório	Número de envios em 2023
FDA	2
Ema	1

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: segmentos de clientes

Pesquisadores de doenças neurológicas

Tamanho da população -alvo: aproximadamente 15.000 pesquisadores neurológicos especializados em todo o mundo

Categoria de pesquisa	Número de pesquisadores em potencial	Distribuição geográfica
Doenças neurodegenerativas	5,200	América do Norte: 42%, Europa: 33%, Ásia-Pacífico: 25%
Pesquisa de Alzheimer	3,800	Estados Unidos: 55%, UE: 30%, resto do mundo: 15%

Empresas farmacêuticas

Total de clientes corporativos em potencial: 78 principais empresas farmacêuticas

• As 20 principais empresas farmacêuticas globais: possíveis metas de colaboração direta
• Tamanho do mercado de desenvolvimento de medicamentos neurológicos: US $ 24,3 bilhões em 2023

Instituições de Pesquisa Médica

Tipo de instituição	Número total	Nível de interesse potencial
Centros de Pesquisa Universitária	412	Alto
Instalações de pesquisa governamental	86	Médio
Fundações de pesquisa privada	203	Alto

Pacientes terapêuticos em potencial

População global de pacientes -alvo: 47,5 milhões de indivíduos com condições neurodegenerativas

• Pacientes de Alzheimer: 32 milhões
• Pacientes de Parkinson: 10 milhões
• Distúrbios neurológicos raros: 5,5 milhões

Comunidade de investimento em biotecnologia

Categoria de investidores	Número de investidores em potencial	Tamanho médio de investimento
Empresas de capital de risco	215	US $ 3,7 milhões
Investidores institucionais	89	US $ 12,5 milhões
Empresas de private equity	47	US $ 8,2 milhões

Alterity Therapeutics Limited (ATTH) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal encerrado em 30 de junho de 2023, a Alterity Therapeutics registrou despesas de P&D de US $ 4,87 milhões.

Ano fiscal	Despesas de P&D
2023	US $ 4,87 milhões
2022	US $ 5,63 milhões

Financiamento de ensaios clínicos

As despesas de ensaios clínicos para o programa principal da empresa direcionados à doença de Parkinson e outros distúrbios neurodegenerativos foram de aproximadamente US $ 3,2 milhões em 2023.

Manutenção da propriedade intelectual

• Custos anuais de arquivamento e manutenção de patentes: US $ 250.000
• Número de patentes ativas: 7
• Cobertura de patente geográfica: Estados Unidos, Europa, Austrália

Funcionários e salários de pessoal científico

Categoria de pessoal	Custo anual	Número de funcionários
Equipe científica	US $ 2,1 milhões	12
Equipe administrativo	US $ 1,3 milhão	8

Custos de infraestrutura de laboratório e tecnologia

Despesas totais de infraestrutura e tecnologia para 2023: US $ 1,5 milhão

• Manutenção de equipamentos de laboratório: US $ 650.000
• Infraestrutura de tecnologia: US $ 850.000

Custos operacionais anuais estimados totais: US $ 9,87 milhões

Alterity Therapeutics Limited (ATHTH) - Modelo de negócios: fluxos de receita

Acordos de licenciamento em potencial

A partir de 2024, a Alterity Therapeutics Limited não relatou acordos de licenciamento ativos que geram receita.

Bolsas de pesquisa

Ano	Fonte de financiamento	Valor de concessão
2023	NIH Small Business Innovation Research (SBIR)	$298,000
2022	Michael J. Fox Foundation	$450,000

Financiamento de pesquisa colaborativa

Parcerias de pesquisa colaborativa a partir de 2024:

• Universidade de Melbourne - Pesquisa de Doenças Neurodegenerativas
• Instituto de Pesquisa de Parkinson

Futura comercialização terapêutica de produtos

Estágio atual de desenvolvimento para candidatos terapêuticos líderes:

• ATH434 para a doença de Parkinson - estágio pré -clínico
• Valor potencial estimado de mercado: US $ 750 milhões

Monetização da propriedade intelectual

Categoria de patentes	Número de patentes	Valor estimado
Tratamentos de doenças neurodegenerativas	7	US $ 12,5 milhões
Abordagem terapêutica de biologia metálica	3	US $ 5,2 milhões

Receita total 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.