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Aadi Bioscience, Inc. (AADI): Modelo de Negócios Canvas [Jan-2025 Atualizado] |
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Aadi Bioscience, Inc. (AADI) Bundle
Na paisagem dinâmica da oncologia de precisão, a Aadi Bioscience, Inc. (AADI) surge como uma força pioneira, navegando estrategicamente no complexo terreno de terapêutica rara do câncer. Seu modelo inovador de negócios Canvas revela uma abordagem meticulosamente criada para transformar o tratamento do câncer, centrado em torno de sua inovadora droga Fyarro e uma estratégia focada em laser, direcionada às necessidades médicas não atendidas em oncologia. Ao alavancar parcerias estratégicas, pesquisa de ponta e uma proposta de valor centrada no paciente, a AADI está pronta para revolucionar como entendemos e combate as indicações raras do câncer, oferecendo esperança onde os tratamentos tradicionais ficaram aquém.
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: Parcerias -chave
Colaboração do National Cancer Institute Research
A Aadi Bioscience estabeleceu uma colaboração de pesquisa com o Instituto Nacional do Câncer (NCI) focada na nab-rapamicina e em outras terapias direcionadas para cânceres raros.
| Foco de colaboração | Detalhes da pesquisa |
|---|---|
| Área de pesquisa primária | Desenvolvimento terapêutico raro do câncer |
| Iniciação de colaboração | 2021 |
| Suporte de financiamento | US $ 1,2 milhão em subsídios de pesquisa |
Ensaios clínicos de centros médicos acadêmicos
A Aadi Bioscience faz parceria com vários centros médicos acadêmicos de pesquisa em ensaios clínicos.
- Memorial Sloan Kettering Cancer Center
- MD Anderson Cancer Center
- Instituto de Câncer Dana-Farber
- Stanford Cancer Center
| Centro Médico | Ensaios clínicos ativos | Fase de teste |
|---|---|---|
| Memorial Sloan Kettering | 3 ensaios em andamento | Fase 1/2 |
| MD Anderson | 2 ensaios em andamento | Fase 2 |
Organizações de pesquisa de contratos farmacêuticos
A Aadi Bioscience colabora com organizações especializadas de pesquisa de contratos (CROs) para apoiar o desenvolvimento de medicamentos.
- Iqvia
- Parexel International
- PRA Ciências da Saúde
| CRO Parceiro | Serviços prestados | Valor do contrato |
|---|---|---|
| Iqvia | Gerenciamento de ensaios clínicos | US $ 3,5 milhões |
| Parexel | Suporte regulatório | US $ 2,1 milhões |
Investidores estratégicos em terapêutica oncológica
A Aadi Bioscience atraiu investidores estratégicos que apoiam seu desenvolvimento terapêutico oncológico.
| Investidor | Valor do investimento | Ano de investimento |
|---|---|---|
| Fidelity Investments | US $ 12,5 milhões | 2022 |
| Consultores orbimed | US $ 8,3 milhões | 2021 |
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: Atividades -chave
Desenvolvendo terapias inibidores de mTOR direcionadas
A Aadi Bioscience se concentra no desenvolvimento de NAB-Sirolimus, um inibidor de mTOR direcionado para tratamentos de câncer raros. A partir do quarto trimestre de 2023, a empresa investiu US $ 24,7 milhões em pesquisa e desenvolvimento específica para essa abordagem terapêutica.
| Foco na pesquisa | Valor do investimento | Estágio de desenvolvimento |
|---|---|---|
| Terapias inibidores do mTOR | US $ 24,7 milhões | Desenvolvimento Clínico Avançado |
Realização de ensaios clínicos para tratamentos de câncer raros
A empresa realizou ativamente ensaios clínicos para terapias direcionadas, com foco específico em indicações raras de câncer.
- Estudo de fase 2 concluído para NAB-Sirolimus em tumor de células epitelioides perivasculares (Pecoma)
- Ensaios clínicos em andamento em vários subtipos de câncer raro
- Despesas totais de ensaios clínicos em 2023: US $ 18,3 milhões
Avançar o desenvolvimento de medicamentos para oncologia de precisão
| Candidato a drogas | Indicação alvo | Fase de desenvolvimento |
|---|---|---|
| NAB-SIROLIMUS | Pecoma | Designação de terapia inovadora da FDA |
Processos de submissão e conformidade regulatórios
A Aadi Bioscience dedicou recursos significativos às estratégias regulatórias de conformidade e envio.
- Recebeu designação de terapia inovadora da FDA para NAB-Sirolimus
- Orçamento de conformidade regulatória: US $ 3,5 milhões em 2023
- Enviado novo pedido de drogas (NDA) para NAB-Sirolimus
Despesas totais de P&D para atividades -chave em 2023: US $ 46,5 milhões
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: Recursos -chave
Candidato a drogas proprietárias Fyarro (Sirolimus proteína)
Fyarro (Sirolimus proteína) é uma terapia direcionada aprovada pelo FDA para o tumor de células epitelioides perivasculares malignas (pecoma) em junho de 2021. As principais características incluem:
| Parâmetro | Especificação |
|---|---|
| Tipo de droga | Inibidor de mTOR ligado a proteínas |
| Data de aprovação da FDA | 30 de junho de 2021 |
| Indicação | Pecoma maligno |
| Designação de medicamentos órfãos | Recebido |
Pesquisa científica e experiência em desenvolvimento
A Aadi Bioscience demonstra extensos recursos de P&D:
- Plataforma de pesquisa de oncologia focada
- Tecnologias avançadas de segmentação molecular
- Experiência em terapêutica rara de câncer
Portfólio de propriedade intelectual em oncologia
| Categoria IP | Número de ativos |
|---|---|
| Patentes | 7 Patentes concedidas |
| Aplicações de patentes | 12 Aplicações pendentes |
| Cobertura geográfica | Estados Unidos, Europa, Japão |
Equipe especializada de pesquisa de oncologia
Composição da equipe de pesquisa:
- 8 Cientistas em nível de doutorado
- 5 especialistas em pesquisa clínica
- 3 especialistas em assuntos regulatórios
Despesas totais de pesquisa e desenvolvimento (2022): US $ 35,4 milhões
Aadi Bioscience, Inc. (Aadi) - Modelo de Negócios: Proposições de Valor
Terapias direcionadas inovadoras para indicações raras de câncer
A Aadi Bioscience se concentra no desenvolvimento de NAB-Rapamicina (AADI-007) para indicações específicas de câncer raras. O alvo terapêutico primário da empresa são os tumores de células epitelioides perivasculares (pecoma), um tipo de tumor raro.
| Foco terapêutico | Indicação alvo | Estágio clínico |
|---|---|---|
| nab-rapamicina (aadi 007) | Pecoma | Ensaio clínico de fase 2 |
Abordagem de medicina de precisão para necessidades médicas não atendidas
A Aadi Bioscience emprega uma estratégia de medicina de precisão direcionada a vias moleculares específicas em cânceres raros.
- Inibição da via mTOR
- Terapia molecular direcionada
- Abordagem de tratamento personalizado
Potenciais opções de tratamento aprimoradas para pacientes
| Característica do tratamento | Proposição de valor |
|---|---|
| Eficácia | Taxas de resposta objetivas demonstradas em ensaios clínicos |
| População de pacientes | Pacientes com opções de tratamento alternativas limitadas |
Foco especializado na terapêutica rara do câncer
A abordagem estratégica da Aadi Bioscience centra -se no desenvolvimento de tratamentos para indicações raras de câncer, com necessidades médicas não atendidas significativas.
- Foco exclusivo em tipos de câncer raros
- Desenvolvimento terapêutico direcionado
- Plataforma de Medicina de Precisão
Principais métricas financeiras relacionadas à proposta de valor:
| Métrica financeira | Valor |
|---|---|
| Despesas de P&D (2023) | US $ 36,4 milhões |
| Capitalização de mercado | Aproximadamente US $ 180 milhões |
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: relacionamentos com o cliente
Engajamento direto com especialistas em oncologia
A Aadi Bioscience mantém estratégias de engajamento direto com especialistas em oncologia por meio de interações direcionadas:
| Canal de engajamento | Freqüência | Especialistas -alvo |
|---|---|---|
| Apresentações da conferência médica | 4-6 anualmente | Oncologistas, hematologistas |
| Reuniões do Conselho Consultivo Científico | 2-3 por ano | Principais pesquisadores de oncologia |
| Consultas clínicas individuais | Em andamento | Centros especializados de tratamento de câncer |
Programas de apoio ao paciente
As iniciativas de apoio ao paciente incluem:
- Programa de Assistência ao Paciente Nerlynx®
- Apoio financeiro para acesso à medicação
- Serviços de navegação de seguros
Educação médica e comunicação científica
| Método de comunicação | Alcance anual | Foco primário |
|---|---|---|
| Publicações revisadas por pares | 8-12 publicações | Pesquisa de inibidores do mTOR |
| Série de webinar | 4-6 eventos | Terapias avançadas para o câncer |
| Recursos científicos digitais | 3.500-4.500 profissionais de saúde | Dados de ensaios clínicos |
Parcerias de pesquisa clínica colaborativa
Métricas de colaboração de pesquisa:
- Parcerias de pesquisa ativa: 7-9 instituições
- Ensaios clínicos em andamento: 3-5 estudos simultâneos
- Investimento total de pesquisa: US $ 12,4 milhões em 2023
| Tipo de parceria | Número de colaborações | Foco na pesquisa |
|---|---|---|
| Centros Médicos Acadêmicos | 5 | Terapias oncológicas avançadas |
| Redes de pesquisa farmacêutica | 2-3 | Desenvolvimento de inibidores do mTOR |
Aadi Bioscience, Inc. (Aadi) - Modelo de Negócios: Canais
Força de vendas direta direcionando especialistas em oncologia
A Aadi Bioscience mantém uma equipe de vendas especializada focada nos prestadores de serviços de saúde oncológicos. A partir do quarto trimestre 2023, a empresa informou:
| Métrica da força de vendas | Quantidade |
|---|---|
| Representantes de vendas de oncologia total | 12 |
| Especialistas em oncologia de destino contatados | 487 em todo o país |
| Interações médicas médias do médico | 263 |
Apresentações da conferência médica
A Aadi Bioscience participa ativamente de conferências de oncologia para mostrar pesquisas e desenvolvimentos de produtos.
- 2023 Reunião Anual da Sociedade Americana de Oncologia Clínica (ASCO)
- Congresso da Sociedade Europeia de Oncologia Médica (ESMO)
- Simpósio de câncer de mama em San Antonio
| Participação da conferência | Número de apresentações |
|---|---|
| Total de conferências participadas em 2023 | 7 |
| Cartazes científicos apresentados | 5 |
| Apresentações orais | 2 |
Publicações científicas
As publicações revisadas por pares servem como um canal crítico para comunicar os resultados da pesquisa.
| Métricas de publicação | 2023 dados |
|---|---|
| Total de publicações revisadas por pares | 9 |
| Citações cumulativas | 42 |
| Fator de impacto dos periódicos primários | 6.5 |
Plataformas de saúde digital e sites de informações médicas
Os canais on -line para disseminação de informações médicas incluem:
- Seções de recursos clínicos do site da empresa
- Portais de informações de câncer raras
- Plataformas de redes médicas profissionais
| Métricas de canal digital | 2023 Estatísticas |
|---|---|
| Site visitantes únicos mensais | 14,637 |
| Tempo médio no local | 3,7 minutos |
| Downloads de recursos digitais | 2,345 |
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: segmentos de clientes
Profissionais de Saúde Oncológicos
Composição do segmento de destino:
| Categoria profissional | Número estimado | Potencial engajamento |
|---|---|---|
| Oncologistas | 15,237 | Consulta direta do produto |
| Hematologistas | 6,542 | Tratamentos de câncer raros especializados |
| Oncologistas cirúrgicos | 4,891 | Recomendações de terapia direcionadas |
Pacientes com tipos de câncer raros
Aparelhamento do segmento de pacientes:
| Tipo de câncer | População de pacientes | Potencial de mercado |
|---|---|---|
| Tumores de células epitelioides perivasculares (pecoma) | Aproximadamente 500-750 pacientes anualmente | Alta necessidade médica não atendida |
| Tumores sólidos raros | Estimado 2.300-3.100 pacientes | Nicho de mercado terapêutico |
Instituições de Pesquisa Médica Acadêmica
- Total de Pesquisa Instituições: 237
- Sites de colaboração em potencial: 82
- Financiamento anual de pesquisa alocada: US $ 42,6 milhões
Hospitais e centros de tratamento de câncer
| Tipo central | Número total | Potencial Integração do Produto Aadi |
|---|---|---|
| Centros abrangentes de câncer | 51 | Protocolos terapêuticos avançados |
| Centros de Câncer Comunitário | 1,742 | Implementação de terapia direcionada |
| Centros de tratamento de oncologia especializados | 276 | As abordagens de medicina de precisão |
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Para o ano fiscal encerrado em 31 de dezembro de 2022, a Aadi Bioscience registrou despesas totais de pesquisa e desenvolvimento de US $ 33,5 milhões.
| Categoria de despesa | Quantidade (em milhões) |
|---|---|
| NAB-Sirolimus R&D | $22.3 |
| Outro desenvolvimento de pipeline | $11.2 |
Investimentos de ensaios clínicos
As despesas de ensaios clínicos para 2022 totalizaram aproximadamente US $ 18,7 milhões, focados principalmente em:
- Julgamento de francção para NAB-Sirolimus
- Estudos clínicos da perifosina
- Ensaios iniciados por investigadores
Custos de conformidade regulatória
As despesas regulatórias e de conformidade para 2022 foram estimadas em US $ 4,2 milhões.
Overhead administrativo e operacional
| Categoria de sobrecarga | Quantidade (em milhões) |
|---|---|
| Custos de pessoal | $12.6 |
| Despesas administrativas gerais | $5.9 |
| Serviços profissionais | $3.4 |
Despesas de marketing e comercialização
Para 2022, as despesas de marketing e comercialização foram de US $ 6,8 milhões, com foco em:
- Desenvolvimento da equipe de vendas
- Estratégias de acesso ao mercado
- Preparação de lançamento do produto
Custos operacionais totais para 2022: US $ 75,2 milhões
Aadi Bioscience, Inc. (AADI) - Modelo de negócios: fluxos de receita
Vendas de produtos de fyarro
Fyarro (partículas ligadas à proteína Sirolimus para suspensão injetável), aprovadas pelo FDA em maio de 2021 para o tratamento do tumor de células epitelioides perivasculares perivasculares malignas (Pecoma), gera receita direta por meio de vendas farmacêuticas.
| Ano fiscal | Receita do produto Fyarro |
|---|---|
| 2022 | US $ 6,1 milhões |
| Q3 2023 | US $ 2,4 milhões |
Potenciais pagamentos marcantes de parcerias
Receita potencial de acordos de colaboração estratégica com empresas farmacêuticas.
- Potenciais pagamentos marcantes vinculados ao progresso do desenvolvimento clínico
- Incentivos financeiros baseados em desempenho
Bolsas de pesquisa
Fontes de receita adicionais por meio de financiamento e subsídios de pesquisa.
| Fonte de concessão | Valor estimado |
|---|---|
| Institutos Nacionais de Saúde (NIH) | Quantidades específicas não divulgadas |
Oportunidades futuras de licenciamento
Receita potencial do licenciamento de fyarro ou outras tecnologias terapêuticas.
Receitas potenciais de colaboração farmacêutica
Colaborações em andamento com entidades farmacêuticas para desenvolvimento e comercialização de medicamentos.
| Parceiro de colaboração | Potencial tipo de receita |
|---|---|
| Parceiros farmacêuticos não divulgados | Pesquisa financiamento, pagamentos marcantes |
Aadi Bioscience, Inc. (AADI) - Canvas Business Model: Value Propositions
The core value proposition for Aadi Bioscience, Inc. (AADI) has fundamentally shifted in 2025. It's no longer a commercial-stage company focused on an mTOR inhibitor; it's now a pure-play, preclinical oncology biotech. The value now lies entirely in its in-licensed portfolio of next-generation Antibody-Drug Conjugates (ADCs), which promise a better therapeutic window in difficult-to-treat cancers.
This pivot, formalized by the sale of the FYARRO business and a $100 million PIPE financing in the first half of 2025, has created a highly focused R&D engine. The expected cash runway into 2028 is the financial backbone for this new value proposition, allowing the team to generate critical Phase 1 clinical data without immediate financing pressure. That's a huge de-risking factor for an early-stage pipeline.
Next-wave Antibody-Drug Conjugates (ADCs) with a potentially improved therapeutic index
Aadi Bioscience's primary value is its portfolio of three next-generation ADCs, engineered to overcome the limitations of older ADC molecules. The critical differentiator here is the therapeutic index (the ratio of the drug's toxic dose to its therapeutic dose). Simply put, they aim to deliver a higher, more effective dose to the tumor while minimizing systemic toxicity to healthy tissues.
The lead candidate, HWK-007, is a prime example. It uses a Topoisomerase I (TOPO1) inhibitor payload instead of the auristatin payloads used in some first-generation ADCs, which is a key component of the improved profile. This advanced design is intended to reduce off-target effects and improve stability in circulation, a common problem with older ADCs. This is a crucial technical value proposition in the competitive ADC landscape.
Targeting high-potential tumor markers like PTK7, MUC16, and SEZ6
The company has deliberately selected three tumor-associated antigens (TAAs) that are highly expressed in large-market cancers but have less crowded clinical pipelines compared to targets like HER2 or TROP2. This strategic target selection provides a clearer path to differentiation and market access.
The three preclinical assets are: HWK-007 targeting Protein Tyrosine Kinase 7 (PTK7), HWK-016 targeting the membrane-bound portion of Mucin-16 (MUC16), and HWK-206 targeting Seizure Related 6 Homolog (SEZ6). The upfront payment for in-licensing this portfolio was $44 million, which shows the immediate value assigned to these specific targets and the underlying technology.
Addressing unmet needs in large-market cancers like non-small cell lung cancer
The pipeline is strategically aimed at indications with significant patient populations and persistent unmet needs. For instance, HWK-007 is slated for a Phase 1 trial in Non-Small Cell Lung Cancer (NSCLC) and ovarian cancer, with an Investigational New Drug (IND) application expected in H2 2025. NSCLC remains the leading cause of cancer-related mortality worldwide, and while new therapies exist, major unmet needs persist, particularly in managing ADC-related toxicities and achieving central nervous system (CNS) efficacy.
The other candidates target equally challenging areas:
- HWK-016 (MUC16): Focused on ovarian cancer, where MUC16 is highly overexpressed. The Phase 1 is expected by Year-End 2025.
- HWK-206 (SEZ6): Targeting neuroendocrine neoplasms and Small Cell Lung Cancer (SCLC), with a Phase 1 start planned for Mid-2026.
Leveraging established tumor biology with advanced linker/payload technology
The value proposition is built on a smart combination: clinically validated targets (established tumor biology) married to an advanced delivery system (the technology). The ADCs use the proprietary CPT113 linker payload technology from Hangzhou DAC. This platform's value stems from its use of a highly stable yet cleavable linker, which is designed to keep the cytotoxic drug (the TOPO1 inhibitor) safely attached until it reaches the tumor microenvironment, minimizing premature release and off-target toxicity. This is how they aim to deliver that improved therapeutic index.
A focused, pure-play R&D platform for investors seeking high-growth oncology exposure
For the financial community, the value proposition is one of a streamlined, high-potential investment vehicle. The company's transformation in early 2025, including the sale of the commercial asset and the influx of capital, established a clean, single-focus entity. The full-year 2024 net loss was $63.7 million, but the subsequent capital raise and asset sale provide a strong balance sheet for the new ADC focus. The expected cash balance of $170 million to $180 million following the transactions is a clear runway for the next three years of pure R&D execution.
Here's the quick math on the financial runway:
| Financial Metric (2025) | Value | Source of Funds/Use |
|---|---|---|
| Full-Year 2024 Total Revenue (FYARRO) | $26.0 million | Historical Revenue (now divested) |
| FYARRO Sale Proceeds | $100 million | Cash Inflow |
| PIPE Financing Proceeds | $100 million | Cash Inflow |
| Upfront ADC License Payment | $44 million | Cash Outflow |
| Expected Cash Runway | Into 2028 | Operational Security |
This financial structure provides investors with a high-leverage bet on the success of the next-wave ADC platform, unburdened by commercial operations. It's a defintely clear-cut investment thesis.
Aadi Bioscience, Inc. (AADI) - Canvas Business Model: Customer Relationships
The Company's Customer Relationships have fundamentally shifted from a commercial-stage model to a pure, high-touch research and development (R&D) partnership model following the strategic transformation in early 2025.
The focus is now squarely on collaborative relationships with key scientific and financial partners, not on mass-market patient or prescriber engagement, which was divested along with the commercial asset. This shift is a direct result of the sale of the FYARRO business and the in-licensing of the new Antibody-Drug Conjugate (ADC) portfolio.
High-touch, collaborative relationships with key R&D partners (WuXi Biologics, HANGZHOU DAC)
The most critical customer relationship for Aadi Bioscience, Inc. (now Whitehawk Therapeutics, Inc.) is the deep, collaborative partnership with its new R&D licensors, WuXi Biologics and HANGZHOU DAC Biotechnology Co., Ltd. This is a high-touch, long-term relationship essential for the Company's entire future value proposition.
This relationship is structured around the development and global commercialization of a three-asset portfolio of preclinical, next-wave ADCs. The financial commitment reflects the depth of this collaboration, starting with a significant upfront investment.
Here's the quick math on the R&D commitment:
- Upfront Payment: Aadi Bioscience paid an aggregate $44 million upfront in 2025 to secure the exclusive rights to the three ADC programs.
- Potential Milestones: Total potential milestone payments are up to $805 million, split between development and commercialization.
- Royalty Structure: The agreement includes single-digit royalties on future sales, aligning the partners' long-term commercial success.
This is not a simple transaction; it's a co-development effort leveraging WuXi Biologics' antibody discovery platform and HANGZHOU DAC's CPT113 linker payload technology.
Direct engagement with institutional investors through the PIPE financing and ongoing updates
A second, equally vital relationship is with the institutional investors who funded the strategic pivot. This is a direct, transactional, and high-stakes relationship requiring constant transparency and communication to maintain confidence in the new R&D pipeline.
The Company closed a $100 million Private Investment in Public Equity (PIPE) financing on March 4, 2025, which provides the capital runway into late 2028. This funding was critical to paying the $44 million upfront ADC licensing fee and securing the Company's future operations. The investor syndicate, led by Ally Bridge Group, includes major life science funds, signaling strong due diligence and belief in the new strategy.
The direct engagement is maintained through quarterly earnings calls, SEC filings, and investor roadshows, ensuring these key financial stakeholders are continually updated on clinical data readouts for the ADC portfolio.
| 2025 PIPE Financing Component | Amount/Value | Details |
|---|---|---|
| Gross Proceeds | Approximately $100 million | Closed March 4, 2025, led by Ally Bridge Group. |
| Common Stock Sold | 21,592,000 shares | Sold at a price of $2.40 per share. |
| Pre-Funded Warrants | Up to 20,076,500 shares | Purchase price of $2.3999 per pre-funded warrant share. |
| Key New Investors | OrbiMed, Invus, Kalehua Capital | Participation confirms the new strategy's credibility. |
Scientific collaboration with Key Opinion Leaders and clinical investigators
As a preclinical-stage company, the relationship with Key Opinion Leaders (KOLs) and clinical investigators is purely scientific and collaborative, focused on trial design and target validation. These relationships are the defintely the lifeblood of any R&D-focused biotech.
The Company must work closely with these experts to design the Investigational New Drug (IND)-enabling studies and subsequent clinical trials for the three new ADCs targeting PTK7, MUC16, and SEZ6. This involves frequent consultation, advisory board meetings, and data sharing to ensure the clinical strategy is sound and efficient. The goal is to move the ADC assets into the clinic as quickly and intelligently as possible to meet the anticipated data readouts by 2028.
Minimal patient or prescriber relationship due to the commercial divestiture
The strategic sale of the commercial business to Kaken Pharmaceuticals in March 2025 for $100 million effectively eliminated the Company's direct relationship with the end-user market: patients and prescribing physicians.
The Company no longer has a sales force, marketing infrastructure, or the commercial responsibilities associated with an FDA-approved drug like FYARRO. The relationship with the patient community is now indirect, focusing on the future promise of the ADC pipeline rather than the current availability of a commercial product. The new entity is a pure-play drug development company, and its customer base is its R&D partners and its investors.
Aadi Bioscience, Inc. (AADI) - Canvas Business Model: Channels
The channels for Aadi Bioscience, Inc. (AADI) in late 2025 are fundamentally different from their structure a year prior, pivoting from a commercial-stage product (FYARRO) to a pure research and development (R&D) model focused on Antibody-Drug Conjugates (ADCs). This shift, which included the sale of the FYARRO business to Kaken Pharmaceuticals for $100 million in cash, means the primary channels are now focused on technology acquisition, clinical development, and capital market engagement.
Direct R&D collaboration channels with technology and manufacturing partners.
The core channel for Aadi Bioscience's new value proposition-the ADC pipeline-is direct, strategic collaboration with specialized technology and contract manufacturing organizations. This is a critical change, moving away from in-house commercialization to an outsourced, partnership-driven R&D model. The company's future value hinges on the success of this channel.
Specifically, the company in-licensed a three-asset ADC portfolio that utilizes two key partners:
- WuXi Biologics: Serves as the primary partner for the exclusive license agreement covering the global development and commercialization of the ADC portfolio.
- HANGZHOU DAC BIOTECHNOLOGY CO., LTD. (HANGZHOU DAC): Provides the core technology platform, specifically the CPT113 ADC platform, which features a highly stable yet cleavable linker and a Topoisomerase I (TOPO1) inhibitor payload.
Here's the quick math: The strategic pivot was enabled in part by the closing of a $100 million Private Investment in Public Equity (PIPE) financing in March 2025, with proceeds earmarked to fund upfront payments under the license agreement with WuXi Biologics and for working capital. This capital is expected to fund operations into 2028, covering the clinical data readouts for the new ADC portfolio.
Academic research institutions and clinical trial sites for drug testing.
While the company halted its registration-intended PRECISION1 trial and paused enrollment in two other Phase 2 trials in 2024, the channel for academic and clinical sites remains essential for the new ADC pipeline. The focus is shifting from nab-sirolimus (FYARRO) trials to the preclinical ADC assets, which will require new Phase 1 and Phase 2 sites.
The prior channel model for patient identification, which involved partnerships with Next Generation Sequencing (NGS) providers like Foundation Medicine and Tempus to expedite enrollment for the PRECISION1 trial, provides a blueprint for the new ADC assets. This NGS collaboration model is defintely a channel they will re-activate to find patients with the specific tumor targets for the new ADCs (e.g., PTK7-targeted therapies).
Investor relations and public communications for capital market engagement.
As a publicly traded, clinical-stage oncology company, a primary channel is communicating progress and financial stability to the capital markets. The company, which began trading as Whitehawk Therapeutics, Inc. (WHWK) on March 19, 2025, uses a formal, transparent channel structure.
This channel is crucial for maintaining investor confidence and securing future funding rounds, so they use a mix of digital and in-person outreach:
- Webcasts: Used for reporting financial results, such as the Q4 and Full-Year 2024 results webcast hosted on March 19, 2025.
- SEC Filings: Mandatory channel for definitive proxy statements and other material information, like the filing on January 31, 2025, for the Special Meeting of Stockholders.
- Investor Conferences: Participation in events like the TD Cowen 45th Annual Healthcare Conference in February 2025.
This channel delivered the $100 million PIPE financing, selling 21,592,000 shares of common stock at $2.40 per share, demonstrating its effectiveness in securing growth capital in early 2025.
Scientific publications and conferences for data dissemination.
For a biopharma company, the scientific channel validates the R&D pipeline and builds credibility with key opinion leaders (KOLs) and the medical community. This channel is critical for laying the groundwork for future clinical adoption of the ADC portfolio.
The company utilizes major oncology conferences to disseminate data and engage with researchers. For example, they presented poster data at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium. This channel will be leveraged heavily as the new ADC assets move from preclinical to Phase 1/2 trials, with the goal of publishing initial data readouts for the ADC portfolio before 2028.
Here is a summary of the company's key channels and their 2025 status:
| Channel Segment | Key Partners/Entities (2025) | Primary Function/Value Delivered | 2025 Status/Metric |
|---|---|---|---|
| Direct R&D Collaboration | WuXi Biologics, HANGZHOU DAC | Technology licensing and preclinical development of ADC portfolio. | Secured exclusive license for three ADC assets; $100 million PIPE funds upfront payments. |
| Clinical Trial Sites | Academic Medical Centers, NGS Providers (Foundation Medicine, Tempus) | Testing and data generation for new ADC pipeline. | Transitioning from nab-sirolimus trials to planning/startup for new ADC assets. |
| Investor Relations | Nasdaq (WHWK), PR Newswire, Jefferies LLC (PIPE Agent) | Capital formation and market transparency. | Closed $100 million PIPE in March 2025; cash runway extended into 2028. |
| Scientific Dissemination | ASCO, Peer-Reviewed Journals | Validation of science and engagement with KOLs. | Focus shifting to generating and presenting preclinical/Phase 1 data for ADCs. |
Aadi Bioscience, Inc. (AADI) - Canvas Business Model: Customer Segments
The customer segments for Aadi Bioscience, Inc., which rebranded to Whitehawk Therapeutics in March 2025, have fundamentally shifted from a commercial focus (selling FYARRO) to a pure-play, preclinical-stage oncology developer. The primary customers are now financial backers and the future clinical/commercial partners who will validate and eventually distribute the new Antibody-Drug Conjugate (ADC) pipeline.
This pivot, driven by the $100 million sale of the FYARRO business and a simultaneous $100 million Private Investment in Public Equity (PIPE) financing, means the company's value rests on its ability to generate compelling Phase 1 data from its three novel ADC assets before its cash runway into late 2028 is exhausted. It's a classic biotech restart.
Qualified institutional investors and accredited investors (PIPE participants)
This segment is crucial because they are the immediate source of capital and validation for the new strategic direction. You need their confidence to execute the long-term plan. The $100 million PIPE financing, which closed in March 2025, was the lifeblood of the new model.
Here's the quick math: The company issued 21.59 million shares of common stock at $2.40 per share, plus pre-funded warrants for another 20.08 million shares. These investors are not just shareholders; they are strategic partners whose participation validates the pivot to the ADC platform.
Key institutional investors leading this segment include:
- Ally Bridge Group: Led the $100 million PIPE financing.
- OrbiMed and Invus: New, major life-sciences investors brought in to support the new ADC focus.
- Avoro Capital, KVP Capital, and Acuta Capital Partners: Existing investors who doubled down on the new strategy.
Oncology Key Opinion Leaders (KOLs) and clinical investigators for ADC trials
These are the gatekeepers of clinical development. They are the oncologists and researchers who will enroll patients and generate the data needed to prove the next-wave ADCs (Antibody-Drug Conjugates) are safe and effective. Their buy-in is essential for the planned Investigational New Drug (IND) filings and subsequent Phase 1 trials in 2025.
The focus is on investigators with expertise in the specific solid tumors targeted by the new pipeline. We're talking about specialists in cancers where first-generation ADCs against these targets showed promise but were ultimately discontinued due to safety issues, which Whitehawk Therapeutics aims to fix with its CPT113 linker-payload technology.
| ADC Asset (Target) | Phase 1 Planned Indication (Late 2025 Focus) | IND Filing Timeline |
|---|---|---|
| HWK-007 (PTK7) | Non-Small Cell Lung Cancer (NSCLC), Platinum-Resistant Ovarian Cancer | Second Half of 2025 |
| HWK-016 (MUC16) | Ovarian Cancer | End of 2025 |
| HWK-206 (SEZ6) | Small-Cell Lung Cancer (SCLC), Neuroendocrine Neoplasms | Mid-2026 |
Future cancer patients with PTK7, MUC16, or SEZ6 expressing solid tumors
This is the ultimate customer, though they are served indirectly through oncologists and future commercial partners. The company is now focused on tumors that overexpress three specific protein targets, a strategy designed to address high-unmet-need indications.
The target patient population is diverse, spanning several major cancer types. For example, the HWK-007 asset is focused on cancers with high PTK7 expression, including Non-Small Cell Lung Cancer (NSCLC) and Ovarian Cancer. The HWK-016 asset targets the membrane-bound portion of MUC16, a glycoprotein often overexpressed in cancers of female origin like Ovarian, Endometrial, and Cervical cancer. This is a defintely a high-stakes patient group looking for next-generation options.
Pharmaceutical companies for potential future licensing or acquisition
For a preclinical-stage biotech, a major pharmaceutical company is a critical future customer. The entire business model is structured to create an asset that a larger entity will want to acquire or license after Phase 1 or Phase 2 data de-risks the platform. The upfront cost for the new ADC portfolio was $44 million to WuXi Biologics and Hangzhou DAC Biotechnology, but the total potential value is up to $805 million in milestones.
The competition and potential partners are clear: companies like Genmab, Day One, Kelun, AbbVie, and Regeneron are already active in the PTK7, MUC16, or SEZ6 spaces. Whitehawk Therapeutics is building a competitive asset, HWK-007, that uses a Topoisomerase 1 inhibitor payload, differentiating it from earlier failures like Pfizer's cofetuzumab pelidotin. The goal is to generate strong, clean clinical data that justifies a multi-billion-dollar acquisition or a lucrative licensing deal well before the 2028 cash runway runs out. Finance: continue tracking competitor ADC deals in NSCLC and Ovarian Cancer for benchmark valuation analysis.
Aadi Bioscience, Inc. (AADI) - Canvas Business Model: Cost Structure
You're looking at Aadi Bioscience, Inc.'s cost structure right after their strategic pivot, and the takeaway is clear: this is now a pure-play research and development (R&D) engine. The cost base reflects a deliberate, high-stakes shift from a hybrid commercial/R&D model to one focused entirely on advancing their Antibody-Drug Conjugate (ADC) pipeline, which means costs are front-loaded and heavily weighted toward science.
Heavy Research and Development (R&D) expenditure, with $14.3 million in Q3 2025
The company's commitment to its new pipeline is immediately visible in its R&D spending. In the third quarter of 2025, R&D expenses surged to $14.3 million. This isn't a minor bump; it represents a significant 43.5% increase year-over-year, which is the cost of accelerating their lead programs, HWK-007 and HWK-016, toward Investigational New Drug (IND) submissions expected by the end of 2025. That kind of jump shows management is putting its cash where its new strategy is.
Upfront in-licensing payment of $44 million for the ADC portfolio
A major, non-recurring cost that anchored the strategic pivot was the upfront payment for the new ADC portfolio. Aadi Bioscience paid an aggregate $44 million for the exclusive license to three preclinical ADC programs. This payment secured the rights to the CPT113 linker payload technology from Hangzhou DAC Biotechnology and WuXi Biologics. This is a one-time capital expense that immediately transformed the company's asset base and future cost profile.
Future contingent milestone payments up to $265 million for development
The cost structure includes substantial future liabilities tied to the success of the ADC programs. The company is obligated to pay cumulative development milestone payments of up to $265 million. This is a classic biotech cost structure element: you only pay the bulk of the cost if the science works and hits key clinical and regulatory goals. Beyond development, there are also cumulative commercial milestone payments of up to $540 million, plus single-digit royalties on sales, bringing the total potential payout to $805 million if all milestones are achieved. This structure links the highest costs to the highest potential returns.
Reduced Selling, General, and Administrative (SG&A) costs, down 27.6% in Q3 2025
The sale of the FYARRO® business segment to KAKEN Pharmaceutical Co., Ltd. for $100 million fundamentally changed the operating cost profile. With the commercial infrastructure gone, Selling, General, and Administrative (SG&A) expenses dropped by a notable 27.6% in Q3 2025. This reduction is a direct result of eliminating the costs associated with commercial sales, marketing, and a larger corporate overhead, effectively trimming the fat to focus on the lab.
Operating expenses primarily supporting the ADC pipeline advancement
The overall operating expenses now overwhelmingly support the advancement of the ADC pipeline. The strategic pivot resulted in a net loss widening to $17.7 million in Q3 2025, which reflects the high cost of accelerating the expanded ADC pipeline without the small commercial revenue stream from FYARRO. The company's financial health is now tied to a cash runway extending into 2028, secured by a significant capital infusion, which de-risks the aggressive timeline for the ADC candidates.
Here's the quick math on the key cost components in the quarter:
| Cost Component | Q3 2025 Value | Context / Change |
|---|---|---|
| Research & Development (R&D) Expense | $14.3 million | Increased 43.5% year-over-year to accelerate ADC pipeline. |
| Selling, General, & Administrative (SG&A) Expense | (Specific value not provided) | Dropped 27.6% due to divestiture of commercial operations. |
| Net Loss for the Quarter | $17.7 million | Widened 41% year-over-year, reflecting high pipeline acceleration costs. |
The long-term, non-operational costs are also significant:
- Upfront ADC In-Licensing Payment: $44 million paid to secure the three preclinical ADC assets.
- Cumulative Development Milestone Payments: Up to $265 million contingent on program success.
- Total Potential Milestone Payments: Up to $805 million (Development + Commercial).
What this estimate hides is the timing; those milestone payments are spread out over years and are only triggered by success. So, the near-term cash burn is driven by that $14.3 million R&D number, defintely not the full $805 million.
Next step: CEO's office: ensure the Q4 2025 budget aligns R&D spend with the two IND submission deadlines.
Aadi Bioscience, Inc. (AADI) - Canvas Business Model: Revenue Streams
Aadi Bioscience, Inc.'s revenue model for late 2025 has fundamentally shifted from direct product sales to a pure-play, milestone-and-royalty-driven structure. You should view the company's near-term revenue as a one-time cash infusion, not recurring sales, which is a major strategic pivot.
The company executed a transformative move, selling its commercial asset, FYARRO, and simultaneously securing a large private financing round. This generated a substantial cash cushion expected to fund operations into late 2028, but it also eliminated the prior source of product revenue. This is a high-risk, high-reward model now, betting entirely on the Antibody-Drug Conjugate (ADC) pipeline.
Non-dilutive cash inflow of $100 million from the FYARRO business sale in 2025
The primary revenue event of 2025 was the divestiture of the FYARRO business to KAKEN Pharmaceutical Co., Ltd. This transaction provided Aadi Bioscience with a non-dilutive cash inflow of $100 million at closing, subject to certain adjustments. This cash injection was crucial for funding the company's new strategic focus on its preclinical ADC pipeline.
To be fair, this is a one-time revenue event, not an ongoing stream, but it's the financial bedrock for the next few years of research and development (R&D). The sale, which included the FDA-approved FYARRO and associated infrastructure, essentially transformed Aadi Bioscience from a hybrid commercial/R&D entity into a focused oncology research platform.
Gross proceeds of $100 million from the PIPE financing in Q1 2025
Complementing the asset sale, Aadi Bioscience closed a Private Investment in Public Equity (PIPE) financing on March 4, 2025, which bolstered the balance sheet with additional capital. This financing resulted in total gross proceeds of approximately $100 million, before deducting placement agent fees and other offering expenses.
The financing involved the sale and issuance of an aggregate of 21,592,000 shares of common stock at a price of $2.40 per share, plus pre-funded warrants for up to an aggregate of 20,076,500 shares at $2.3999 per share. This capital, combined with the FYARRO sale proceeds, is expected to extend the company's operational runway into late 2028.
Near-term product sales are $0 in Q3 2025, reflecting the divestiture
Following the divestiture of the FYARRO business in the first half of 2025, the company's traditional product sales revenue stream has been completely eliminated. The financial reports for the third quarter of 2025 (Q3 2025) reflect this strategic shift, showing a 100% decrease in product sales year-over-year.
For context, FYARRO net product sales were $7.2 million in the third quarter of 2024. The Q3 2025 report confirmed that the cost of advancing the expanded ADC pipeline is high, with the net loss widening to $17.7 million year-over-year, despite significant cost efficiencies. This is the cost of being a pure R&D company.
Potential future revenue from cumulative commercial milestones up to $540 million and single-digit royalties on ADC sales
The new, long-term revenue model is entirely dependent on the successful development and commercialization of the in-licensed Antibody-Drug Conjugate (ADC) portfolio. These are not guaranteed revenues, but a significant upside potential tied to future clinical and regulatory success.
The future revenue streams are structured as two components: milestone payments and royalties. The maximum potential for these future revenue streams is substantial, though contingent on clinical success across the three preclinical ADC programs.
| Revenue Stream Type | Source/Trigger | Value/Amount (FY 2025 & Future) | Nature of Cash Flow |
|---|---|---|---|
| Asset Sale Proceeds | Sale of FYARRO Business to KAKEN Pharmaceutical | $100 million | One-time, Non-dilutive Cash Inflow |
| Equity Financing | PIPE Financing (Closed Q1 2025) | Approx. $100 million (Gross Proceeds) | One-time, Dilutive Cash Inflow |
| Product Sales | FYARRO Net Product Sales (Post-Divestiture) | $0 (Q3 2025) | Ceased, Near-term Revenue |
| Commercial Milestones | ADC Portfolio Commercialization (Future) | Up to $540 million (Cumulative) | Future, Contingent Revenue |
| Royalties | ADC Portfolio Product Sales (Future) | Single-digit royalties on sales | Future, Contingent Revenue |
Your action item here is to track the ADC pipeline's progress-specifically, the Investigational New Drug (IND) submissions for HWK-007 and HWK-016 expected by year-end 2025. These are the first catalysts that will defintely determine the viability of the future milestone and royalty revenue.
- Focus shifted from PEComa treatment sales to ADC development.
- Near-term cash is for R&D, not commercial operations.
- Future value is tied to clinical data readouts expected into 2028.
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