Akari Therapeutics, PLC (AKTX): Modelo de negócios Canvas [Jan-2025 Atualizado]

Akari Therapeutics, PLC (AKTX) surge como uma empresa pioneira de biotecnologia dedicada a transformar o tratamento de doenças raras por meio de terapias direcionadas inovadoras. Ao alavancar uma abordagem científica sofisticada e uma pesquisa de ponta, essa organização dinâmica está estrategicamente posicionada para desenvolver tratamentos inovadores para condições complexas inflamatórias e mediadas por complemento que há muito permanecem mal atendidas na paisagem médica. Seu modelo abrangente de negócios de negócios revela uma estratégia meticulosamente criada que combina experiência científica avançada, parcerias estratégicas e um profundo compromisso com a medicina de precisão, oferecendo esperança a pacientes que enfrentam condições médicas desafiadoras e representando uma força potencialmente transformadora na terapêutica de doenças raras.

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica para desenvolvimento de medicamentos para doenças raras

Instituição	Foco de colaboração	Área de pesquisa
Escola de Medicina de Harvard	Pesquisa do sistema de complemento	Doenças inflamatórias raras
Universidade da Pensilvânia	Estudos pré -clínicos	Distúrbios de neutrófilos

Organizações de pesquisa contratada (CROs) para ensaios clínicos

Nome do CRO	Fase de teste	Candidato a drogas
Icon plc	Fase 2/3	Cobre para a Hidradenitis Supurativa
Medpace	Desenvolvimento Clínico	Terapêutica de doenças raras

Parceiros de fabricação farmacêutica

• Lonza Group AG - Parceiro de fabricação para produção de biológicos
• Patheon Pharmaceuticals - fabricação de medicamentos em larga escala

Potenciais investidores estratégicos em terapêutica de doenças raras

Tipo de investidor	Foco de investimento	Faixa de investimento potencial
Empresas de capital de risco	Biotecnologia de doenças raras	US $ 5-15 milhões
Armas de risco corporativas farmacêuticas	Desenvolvimento terapêutico em estágio inicial	US $ 10-25 milhões

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de terapias de doenças raras direcionadas

A Akari Therapeutics se concentra no desenvolvimento de terapias para doenças raras mediadas por complemento. A partir de 2024, a empresa se concentrou:

• Desenvolvimento da cobertura (nomacopano) para hemoglobinúria noturna paroxística (PNH)
• Abordagens terapêuticas direcionadas para condições raras autoimunes e inflamatórias

Métrica de P&D	2024 dados
Despesas anuais de P&D	US $ 12,4 milhões
Programas de pesquisa ativa	3 áreas terapêuticas primárias
Equipe de pesquisa	18 pesquisadores dedicados

Gerenciamento de ensaios pré -clínicos e clínicos

A estratégia de desenvolvimento clínico envolve progressão sistemática de candidatos terapêuticos.

Fase de ensaios clínicos	Status atual
Ensaios de fase 2	1 estudo ativo na indicação de PNH
Fase 3 Trabalho preparatório	Discussões regulatórias em andamento

Processos de conformidade regulatória e aprovação de medicamentos

• Interação FDA para vias terapêuticas de doenças raras
• Engajamento regulatório da EMA
• Monitoramento contínuo de conformidade

Proteção e Gerenciamento de Propriedade Intelectual

Categoria IP	2024 Detalhes
Patentes ativas	7 Patentes concedidas
Famílias de patentes	3 plataformas de tecnologia centrais

Pesquisa em Medicina Translacional

Áreas de foco:

• Modulação do sistema de complemento
• Mecanismos raros de doenças autoimunes
• As abordagens de medicina de precisão

Métrica de pesquisa translacional	2024 Medição
Colaborações de pesquisa	2 parcerias acadêmicas
Programas de tradução	4 iniciativas de pesquisa ativa

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: Recursos -chave

Especializada experiência científica e médica

A partir de 2024, a Akari Therapeutics tem uma equipe central de 12 pesquisadores científicos especializados com experiência em terapêutica de doenças raras.

Categoria profissional	Número de profissionais
Pesquisadores de doutorado	7
Médicos médicos	3
Especialistas em pesquisa clínica	2

Plataforma de Desenvolvimento de Medicamentos Proprietários

Akari Therapeutics desenvolveu um plataforma de inibição de complemento direcionada focado em doenças raras.

• A plataforma se concentra em doenças inflamatórias e metabólicas mediadas por complementar
• Desenvolveu tecnologia especializada para intervenções terapêuticas direcionadas

Portfólio de propriedade intelectual

A partir de 2024, a Akari Therapeutics possui 8 famílias de patentes ativas relacionados às suas tecnologias terapêuticas.

Categoria de patentes	Número de patentes
Compostos terapêuticos	4
Mecanismos de entrega de medicamentos	2
Protocolos de tratamento	2

Instalações de pesquisa e infraestrutura de laboratório

Akari Therapeutics mantém 1 Instalação de Pesquisa Primária com infraestrutura de laboratório especializada.

• Espaço total de laboratório: 5.000 pés quadrados
• Equipamento avançado de biologia molecular
• Cultura de células e recursos de pesquisa genômica

Dados de ensaios clínicos e ativos de pesquisa

A empresa acumulou dados significativos de pesquisa clínica em vários programas terapêuticos.

Métrica do ensaio clínico	Status atual
Ensaios clínicos concluídos	3
Ensaios clínicos em andamento	2
Pontos de dados do paciente	Aproximadamente 250

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: proposições de valor

Terapias direcionadas inovadoras para doenças inflamatórias e mediadas por complemento raras

A Akari Therapeutics se concentra no desenvolvimento de terapêuticas especializadas, visando condições inflamatórias raras, especificamente:

Área da doença	Alvo primário	Estágio de desenvolvimento
Hemoglobinúria noturna paroxística (PNH)	Sistema de complemento	Estágio clínico
Síndrome de Guillain-Barré	Resposta inflamatória	Pesquisa pré -clínica

Potenciais tratamentos inovadores para populações de pacientes mal atendidas

O oleoduto terapêutico -chave se concentra em doenças raras com opções de tratamento limitadas:

• Tumores sólidos metastáticos resistentes ao pentebrolizumabe
• Distúrbios raros mediados por complemento
• Condições neurológicas inflamatórias

Abordagem científica avançada para condições médicas complexas

A estratégia científica aproveita plataformas tecnológicas avançadas:

Plataforma de tecnologia	Mecanismo	Aplicação potencial
Inibição do complemento	Modulação imunológica direcionada	Doenças inflamatórias raras
Biológicos de precisão	Direcionamento molecular	Intervenção específica da doença

Soluções terapêuticas personalizadas com foco em medicina de precisão

Medicina de precisão Aproximação de direcionamento de subgrupos de pacientes específicos:

• Protocolos de tratamento individualizados
• Estratégias terapêuticas baseadas em genômicas
• Intervenções moleculares direcionadas

Principais métricas financeiras (a partir de 2023):

Métrica	Valor
Pesquisar & Despesas de desenvolvimento	US $ 24,3 milhões
Investimento de ensaios clínicos	US $ 15,7 milhões

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com comunidades de pacientes com doenças raras

A Akari Therapeutics se concentra em populações de doenças raras, direcionando especificamente pacientes com doenças mediadas por complementar.

Métricas de interação da comunidade de pacientes	2024 dados
Grupos de apoio a doenças raras engajadas	7 redes específicas de pacientes
Eventos anuais de divulgação de pacientes	12 eventos virtuais e pessoais
Programa de Educação do Paciente Alcance	Aproximadamente 500 pacientes

Consulta profissional médica e suporte

Engajamento direcionado com profissionais médicos especializados em tratamento de doenças raras.

• Equipe dedicada de assuntos médicos de 6 especialistas
• Reuniões trimestrais do Conselho Consultivo Médico Especialista
• Programas contínuos de educação médica

Comunicação de participantes do ensaio clínico

Estratégia de comunicação estruturada para participantes do ensaio clínico.

Métricas de comunicação de ensaios clínicos	2024 dados
Ensaios clínicos ativos	3 ensaios em andamento
Popatle Communication Points Touchpoints	Atualizações mensais e relatórios trimestrais de progresso
Taxa de retenção de pacientes	87% nos ensaios atuais

Programas de assistência e suporte do paciente

Mecanismos abrangentes de suporte para pacientes que acessam tratamentos terapêuticos.

• Cobertura do Programa de Assistência Financeira
• Helpline de apoio ao paciente 24 horas por dia, 7 dias por semana
• Serviços de coordenação de acesso à medicação

Interações da Conferência Científica e do Simpósio Médico

Engajamento estratégico em fóruns médicos e científicos.

Métricas de participação na conferência	2024 dados
Conferências científicas compareceram	8 Conferências Internacionais
Apresentações entregues	5 apresentações de pesquisa
Oportunidades de rede de simpósio médico	15 conexões principais da indústria estabelecidas

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: Canais

Equipe direta de vendas médicas

A partir do quarto trimestre de 2023, a Akari Therapeutics emprega uma força de vendas especializada de 7 profissionais médicos direcionados a especialistas em doenças raras e centros de hematologia.

Métrica da equipe de vendas	Quantidade
Total de representantes de vendas	7
Cobertura geográfica	Estados Unidos e mercados europeus
Experiência média de vendas	12,5 anos

Conferências médicas especializadas

A Akari Therapeutics participa de 12 a 15 conferências médicas direcionadas anualmente, concentrando-se em doenças raras e distúrbios hematológicos.

• Reunião Anual da Sociedade Americana de Hematologia (Ash)
• Congresso da Associação Europeia de Hematologia (EHA)
• Doença rara e conferência de drogas órfãs

Publicações científicas online

A empresa mantém uma presença digital ativa através de 8 a 10 canais de publicação revisados ​​por pares em 2024.

Canal de publicação	Publicações anuais
Blood Journal	3
Jornal de Investigação Clínica	2
Medicina da natureza	1

Redes de prestadores de serviços de saúde

Akari mantém relacionamentos com 65 centros de tratamento especializados na América do Norte e na Europa.

• Centros Médicos Acadêmicos: 22
• Clínicas de Hematologia Especializada: 35
• Hospitais de pesquisa: 8

Parcerias da indústria de biotecnologia

Em 2024, a Akari Therapeutics estabeleceu 4 parcerias estratégicas com empresas de biotecnologia e farmacêutica.

Empresa parceira	Foco em parceria	Ano estabelecido
Novartis	Pesquisa de doenças raras	2022
Pfizer	Colaboração de ensaios clínicos	2023
Pharmaceuticals de vértice	Desenvolvimento de medicamentos	2024

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: segmentos de clientes

Pacientes com doenças raras

População de pacientes específica direcionada a PNH (hemoglobinúria noturna paroxística) e outros distúrbios hematológicos raros.

Categoria de doença	População estimada de pacientes	Potencial de tratamento anual
Pnh	8.000 pacientes nos Estados Unidos	US $ 500.000 - US $ 700.000 por paciente anualmente
Distúrbios mediados por complemento	Aproximadamente 5.000 pacientes globalmente	US $ 450.000 - US $ 600.000 por paciente anualmente

Especialistas em hematologia

Profissionais médicos primários direcionados a abordagens de tratamento especializadas.

• Estimado 3.200 especialistas em hematologia nos Estados Unidos
• Aproximadamente 65% tratando ativamente distúrbios do sangue raros
• Orçamento médio de pesquisa anual: US $ 250.000 por especialista

Pesquisadores de imunologia

Comunidade de pesquisa acadêmica e farmacêutica focada em doenças mediadas por complementar.

Categoria de pesquisa	Número de pesquisadores ativos	Financiamento anual de pesquisa
Instituições acadêmicas	1.500 pesquisadores	Financiamento total de pesquisa total de US $ 75 milhões
Pesquisa farmacêutica	850 pesquisadores especializados	US $ 120 milhões no financiamento total de pesquisa

Sistemas hospitalares

Instituições de saúde especializadas em tratamento e tratamento de doenças raras.

• Alvo: 250 centros de tratamento especializados na América do Norte
• Volume anual de tratamento potencial: 1.200 pacientes
• Investimento estimado do centro de tratamento: US $ 2,5 milhões por centro

Centros de tratamento de doenças raras

Instalações médicas especializadas com foco em distúrbios hematológicos complexos.

Região geográfica	Número de centros especializados	Capacidade anual de tratamento do paciente
Estados Unidos	87 centros	650 pacientes
União Europeia	62 centros	450 pacientes
Ásia-Pacífico	41 centros	300 pacientes

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Akari Therapeutics registrou despesas de P&D de US $ 24,3 milhões.

Categoria de despesa	Valor ($)
Pesquisa pré -clínica	8,7 milhões
Desenvolvimento de medicamentos	12,5 milhões
Custos da plataforma de tecnologia	3,1 milhões

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram US $ 16,9 milhões.

• Custos de teste de fase I: US $ 5,2 milhões
• Fase II Custos de estudo: US $ 9,7 milhões
• Despesas de recrutamento de pacientes: US $ 2 milhões

Investimentos de conformidade regulatória

Os custos de conformidade regulatória para 2023 foram de US $ 3,6 milhões.

Área de conformidade	Despesas ($)
Preparação de envio da FDA	1,5 milhão
Documentação regulatória	1,2 milhão
Monitoramento de conformidade	0,9 milhão

Manutenção da propriedade intelectual

As despesas de propriedade intelectual em 2023 totalizaram US $ 1,8 milhão.

• Custos de arquivamento de patentes: US $ 0,9 milhão
• Taxas de manutenção de patentes: US $ 0,6 milhão
• Proteção Legal IP: US $ 0,3 milhão

Recrutamento e retenção de talentos científicos

Os custos totais de aquisição de pessoal e talento para 2023 foram de US $ 7,2 milhões.

Categoria de despesa de talentos	Valor ($)
Salários da base	5,4 milhões
Despesas de recrutamento	0,8 milhão
Treinamento e desenvolvimento	1 milhão

Akari Therapeutics, PLC (AKTX) - Modelo de negócios: fluxos de receita

Potenciais acordos futuros de licenciamento de medicamentos

A partir do quarto trimestre de 2023, a Akari Therapeutics não relatou nenhum contrato de licenciamento de medicamentos ativo que gera receita.

Bolsas de pesquisa

Fonte de concessão	Quantia	Ano
Institutos Nacionais de Saúde (NIH)	$750,000	2023

Contratos de desenvolvimento farmacêutico colaborativo

Nenhum contrato colaborativo específico foi relatado em 2023 demonstrações financeiras.

Potencial comercialização de produtos

• Ensaios clínicos em andamento para Nomacopan (Coversin) em doenças raras
• Receita potencial do desenvolvimento de medicamentos órfãos

Monetização da propriedade intelectual

A partir de 2023, nenhuma monetização direta da propriedade intelectual relatada.

Receita total para o ano fiscal de 2023: US $ 1.421.000

Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Value Propositions

You're looking at the core value Akari Therapeutics, Plc is trying to deliver with its pipeline assets as of late 2025. It's all about differentiation in crowded spaces, especially oncology and ophthalmology.

Novel ADC payload (PH1) designed to overcome resistance in solid tumors

The value here is moving beyond the established payload classes that are showing limitations in the market. The existing landscape heavily relies on two toxin classes: DNA damaging agents and microtubule inhibitors. For context, the 2023 sales for products using DNA damaging agents were reported around $1.0B and $2.7B, while microtubule inhibitors were around $1.75B and less than $100M for different products, based on a corporate presentation snapshot. Akari Therapeutics, Plc's lead candidate, AKTX-101, uses the novel PH1 payload, a spliceosome inhibitor, which disrupts RNA splicing. This mechanism is designed to deliver direct tumor cell cytotoxicity and, critically, generate neoantigens. Preclinical data showed that Trastuzumab-PH1 drives macrophages toward an anti-tumor state and causes expansion of B cell clones with subsequent IgM antibody production. Akari Therapeutics, Plc is initiating IND-enabling studies for AKTX-101, which targets the Trop2 receptor.

Potential for a long-acting geographic atrophy (GA) therapy with PAS-nomacopan

For geographic atrophy, the value proposition centers on patient convenience and potentially mitigating a known complication. PAS-nomacopan is a long-acting candidate that received positive and constructive Pre-IND feedback from the US FDA on July 29, 2024, setting the stage for an IND submission in 2025. The goal is to support a clinical dose interval of 3 months or longer, potentially translating to only 3 or 4 intravitreal injections a year. This compares to existing therapies where dose intervals are shorter.

Dual mechanism of action in nomacopan (C5 and LTB4 inhibition)

The investigational nomacopan, which PAS-nomacopan is based on, offers a dual hit. It is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The LTB4 inhibition component is specifically important for the GA indication, as LTB4 can upregulate VEGF-A production, which is linked to choroidal neovascularization (CNV) risk associated with approved inhibitors. The company is advancing this long-acting version for intravitreal treatment of GA.

Targeting high-unmet-need oncology indications with AKTX-101

AKTX-101 is positioned to address niches where current ADCs fall short. The company sees a large opportunity in solid tumors like lung, colon, and gastric cancers. The value here is the potential for enhanced activity as a single agent, low off-target toxicity, and the ability to induce epitope spreading, which means resistant cells can be killed by the immune response.

Platform technology for generating multiple ADC candidates

The underlying platform technology provides the capability to generate a pipeline of candidates beyond the lead. This platform uses the PH1 payload as its cornerstone to build ADCs against a wide range of tumors. The company is advancing AKTX-102, which is expected to disclose its target and more details by the end of 2025. The platform is designed to fuel this growing pipeline.

Here is a quick look at the financial context surrounding these development efforts as of late 2025:

Financial Metric	Value as of Late 2025	Date/Context
Cash and Equivalents	$2.5 million	September 30, 2025
Net Loss (Q3 2025)	$6.4 million	Three months ended September 30, 2025
Ordinary Shares Outstanding	71.5 billion	November 13, 2025
Net Proceeds from March 2025 Offering (YTD)	$5.9 million	Year to Date September 30, 2025

The pipeline focus is clear, but the cash position requires you to watch capital allocation closely.

The key value drivers for the ADC pipeline include:

• Direct Tumor Cell Cytotoxicity from PH1 payload.
• Generation of Neoantigens stimulating immune response.
• Ability to Induce Epitope Spreading.
• Potential Synergy With IO (Immuno-Oncology) agents.

Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Customer Relationships

High-touch, direct engagement with Key Opinion Leaders (KOLs) in oncology

Akari Therapeutics, Plc engages directly with scientific leadership to validate its novel ADC platform. The company announced the formation of its Scientific Advisory Board and the inaugural appointment of renowned Medical Oncologist, Sara A. Hurvitz, MD, FACP, in October 2025. CEO Abizer Gaslightwala provided an overview of ADC innovation, highlighting the novel PH1 payload, in a CEO Corner segment released November 25, 2025. Data regarding the spliceosome targeting payload, PH1, was presented at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting in November 2025.

• Appointment of Dr. Sara A. Hurvitz to Scientific Advisory Board in October 2025.
• Presentation of PH1 payload data at the SITC Meeting in November 2025.

Intensive investor relations to secure ongoing equity financing

Securing capital is a continuous relationship management activity for Akari Therapeutics, Plc. The company executed two significant financing events in 2025 alone. The Interim CFO brings over 20 years of leadership experience, including raising over $170M+ in capital. The company has a history involving 8 institutional investors. The latest reported financing activity in late 2025 involved a registered direct offering to raise approximately $2.5 million at $0.80 per ADS. This followed a private placement in March 2025 that raised approximately $7.6 million, priced at $0.87 per ADS based on the February 28, 2025, closing price. The company reported a negative EBITDA of $12.8 million in the last twelve months leading up to October 2025.

Financing Event Date (2025)	Gross Proceeds	ADS Price	Investor Support
October 2025	Approximately $2.5 million	$0.80 per ADS	Registered Direct Offering
March 2025	Approximately $7.6 million	$0.87 per ADS	Private Placement (Existing Shareholders/Insiders)

The closing price for Akari Therapeutics, Plc ADSs on July 25, 2025, was $1.12 per ADS. Historically, the largest funding round was a Post IPO round for $75M in September 2015, contributing to a total historical raise of $2.43M over 9 rounds.

Direct communication with regulatory bodies (FDA) for IND/clinical guidance

Engagement with the U.S. Food and Drug Administration (FDA) is critical for advancing pipeline assets. Akari Therapeutics, Plc received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, concerning PAS-nomacopan for Geographic Atrophy (GA). The company expects to submit the Investigational New Drug (IND) application in 2025 to initiate the first clinical studies for this treatment. A full-scale batch of the drug substance, intended for IND-enabling studies and initial clinical development, was successfully manufactured and released under Good Manufacturing Practices (GMP) by Wacker Biotech GmbH. Earlier in its history, the company had a successful End of Phase II meeting with the FDA regarding Nomacopan for Bullous Pemphigoid (BP) in August 2020.

• IND submission for PAS-nomacopan anticipated in 2025.
• Positive Pre-IND feedback received from FDA on July 29, 2024.
• GMP-compliant drug substance manufactured by Wacker Biotech GmbH.

Strategic business development with potential licensing partners

Akari Therapeutics, Plc actively manages relationships to out-license non-core or complementary assets. The company is specifically seeking external licensing partners for its preclinical PAS-nomacopan program in Geographic Atrophy (GA). Furthermore, the company stated an intent to seek license partners for its TROP-2 ADC program. The merger with Peak Bio, which closed November 14, 2024, was structured to emphasize business development and licensing opportunities. Potential deal structures previously mentioned include an Undisclosed upfront payment with up to $325.5M in milestones and royalties, or another structure involving $50M upfront for rights outside of China and a total deal potential of $1.15B plus royalties.

The company's ADC Platform is designed to generate novel ADC candidates against any relevant target, supporting future partnership opportunities.

Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Channels

The Channels for Akari Therapeutics, Plc (AKTX) are currently centered on external engagement for data dissemination and capital raising, given the preclinical stage of its lead asset, AKTX-101, and the stated need to secure non-dilutive capital.

Direct-to-Specialty-Physician sales force for future commercialized products

Akari Therapeutics, Plc (AKTX) has not established a direct-to-specialty-physician sales force as of late 2025, which is typical for a company with a preclinical-stage lead program, AKTX-101. The current channel strategy for future commercialization is heavily weighted toward securing a strategic partner, which would then provide the necessary infrastructure, including a sales force, upon successful clinical progression. The company's operational focus is on advancing the ADC platform, with cash on hand previously guided to be sufficient to fund planned operations into September 2025. The net loss from operations for the first quarter of 2025 was approximately $3.7 million.

Out-licensing agreements with larger pharmaceutical companies

The pursuit of out-licensing agreements is a primary channel for generating non-dilutive capital and advancing the pipeline. The company is actively seeking a licensing/strategic partner for AKTX-101 (TROP2 PH1 ADC). Furthermore, Akari Therapeutics, Plc (AKTX) is leveraging opportunities for non-dilutive capital through partnering of its legacy pipeline assets. The company announced a $2.5 million registered direct offering in October 2025, indicating an ongoing need for capital to fund research and development activities, which are critical to making out-licensing more attractive.

The strategic focus on partnering is underscored by the appointment of a seasoned Head of BD, Oncology (Mark Kubik), to bolster partnering capability.

Scientific publications and conferences to disseminate preclinical data

Dissemination of preclinical data through scientific venues serves as a key channel to validate the technology and attract potential partners. The company planned to present anticipated PH1 Payload preclinical data at a scientific conference in the second half of 2025. Specific engagement channels included:

Event/Publication Channel	Date/Timeframe	Key Data/Activity
SITC November 2025 Poster	November 2025	Poster: A Novel Splicing- Targeted ADC Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential beyond Cytotoxicity
40th Annual Society for Immunotherapy of Cancer Meeting	Early November 2025	Presented promising data for PH1 payload; Trastuzumab-PH1 ADC showed a 74% complete response rate in colon cancer models when combined with anti-PD1 therapy
H.C. Wainwright 27th Annual Global Investment Conference	September 8-10, 2025	CEO Abizer Gaslightwala delivered a presentation and conducted one-on-one meetings with registered investors

The presentation webcast at the H.C. Wainwright conference was available starting September 5, 2025, at 7:00 AM ET and remained accessible on the company's website for 90 days.

Investor presentations and corporate website for capital markets

Investor engagement is a critical channel for maintaining liquidity and funding operations. The company utilized updated investor presentations, such as the one released on August 19, 2025, for stakeholder meetings. The financial context surrounding these capital market activities is stark:

• Cash on hand as of March 31, 2025: approximately $2.6 million.
• Net proceeds from a March 2025 offering: approximately $6.0 million.
• October 2025 Registered Direct Offering Price: $0.80 per ADS.
• October 2025 Offering Gross Proceeds: approximately $2.5 million.
• Market Capitalization (August 2025): $32.94M.
• Market Capitalization (October 2025): $32 million.
• Closing Price of ADSs (July 25, 2025): $1.12 per ADS.
• Maximum aggregate offering price under July 2025 Form S-3 shelf registration: $75 million.
• Share Purchase Agreement with White Lion Capital (August 29, 2025): up to $25 million in newly issued Ordinary Shares.

The negative EBITDA for the last twelve months leading up to October 2025 was $12.8 million.

Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Customer Segments

Large pharmaceutical/biotech companies for ADC platform or nomacopan licensing

Akari Therapeutics, Plc is actively seeking licensing or strategic partners for its lead asset, AKTX-101, which targets the Trop2 receptor. The company's market capitalization as of November 2025 was reported at $22.8 million. For the three months ended March 31, 2025, the net loss from operations was approximately $3.7 million. The platform technology is designed to generate novel ADC candidates against any relevant target, allowing for multiple program developments for additional licensing partnerships.

Oncologists and hematologists treating solid tumors (future)

This segment is targeted by the development of AKTX-101, a preclinical stage ADC candidate. The focus is on solid tumors where the Trop2 receptor is expressed in the highest number of cancer types.

• Targeted tumor types include lung, breast, colon, and prostate cancers.
• AKTX-101 utilizes the novel PH1 payload, a spliceosome inhibitor.
• Preclinical data presented in November 2025 showed a 74% complete response rate in colon cancer models when a Trastuzumab-PH1 ADC was combined with anti-PD1 therapy.

Patients with solid tumors targeted by the AKTX-101 program

The AKTX-101 program is focused on a variety of solid tumors expressing the Trop2 receptor. The company is advancing IND-enabling studies with plans to move this ADC into clinical trials. The platform's ability to precisely tune assets allows for program development across a range of cancers.

Deal Type	Upfront Payment	Total Potential Value (Milestones & Royalties)	Date Announced
Licensing	$130 million	Up to $1.34 billion	May 2025
Licensing	$47 million	Up to $1.16 billion	January 2025
Licensing	$50 million	Up to $1.15 billion (outside China rights)	January 2025

Patients with geographic atrophy (GA) for the PAS-nomacopan program

While the HSCT-TMA clinical stage program with nomacopan was suspended in May 2024, the potential patient segment for a GA therapy is substantial, as reflected in market data. The global population of geographic atrophy sufferers is estimated to be more than 8 million.

• The Geographic Atrophy (GA) Market size across the top 7 markets (US, EU4, UK, Japan) was valued at USD 25.6 Billion in 2024.
• The GA Market is projected to grow from USD 24.93 Billion in 2025 to USD 51.39 Billion by 2035.
• In the US, approximately 1.49 million Americans are affected by late-stage, vision-threatening age-related macular degeneration (AMD), which includes GA, as of January 2025.
• The US market for AMD drugs reached US$ 10.57 billion in 2024 and is expected to reach US$ 11.69 billion in 2025.

Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Cost Structure

You're looking at the cost side of Akari Therapeutics, Plc's business model as of late 2025. Since they are pre-commercial, the entire structure is built around funding their research and development, which means operating expenses are the main story. The total loss from operations for Q3 2025 hit $7.4 million.

Here's a breakdown of the key expense categories for the third quarter ended September 30, 2025:

Cost Component	Q3 2025 Amount (USD)	Notes
Research and Development (R&D) Expenses	$249 thousand	Up from $143 thousand in Q3 2024.
General and Administrative (G&A) Expenses	$1.975 million	Approximates the $2.0 million figure; up from $1.709 million in Q3 2024.
Impairment Loss on Intangible Assets	$5.18 million	Full write-off of the in-process R&D related to the PHP-303 program.
Total Operating Expenses	$7.4 million	Sum of R&D, G&A, and other operating costs before the impairment charge.

The most significant single event impacting the cost structure in Q3 2025 was the $5.18 million impairment loss on other intangible assets. This charge was specifically tied to the in-process R&D associated with the PHP-303 program, which the company fully impaired and wrote off.

You can see how the core operating costs stack up:

• Research and Development (R&D) expenses were $249 thousand for the quarter.
• General and Administrative (G&A) expenses were $1.975 million.

The G&A line item is where you'll find the costs associated with being a public entity and compensating the management team. Specifically, non-cash stock-based compensation accounted for $685 thousand during Q3 2025.

The costs associated with maintaining the ADC discovery platform and the Intellectual Property (IP) portfolio are embedded within the R&D and G&A figures, as the company is focused on its Antibody-Drug Conjugate (ADC) pipeline, including the lead asset AKTX-101. Remember, patent amortization is calculated over the shorter of the legal or useful life, and costs to maintain and defend patents are expensed in the period issued.

For perspective on the nine-month run rate ending September 30, 2025:

• R&D expenses totaled $1.7 million.
• G&A expenses totaled $7.139 million.

Finance: draft the 13-week cash view by Friday, focusing on burn rate excluding the one-time impairment.

Akari Therapeutics, Plc (AKTX) - Canvas Business Model: Revenue Streams

Akari Therapeutics, Plc (AKTX) revenue streams as of late 2025 are primarily non-operational, centered on capital raising activities to fund its Antibody Drug Conjugate (ADC) pipeline development.

Equity financing from public offerings provided significant, though intermittent, capital injections throughout 2025.

• Equity financing from public offerings, like the $5.9 million net proceeds YTD 2025.
• Financing activities included a March 2025 offering with $6.0 million gross proceeds, of which $4.0 million was received in April 2025.
• A Registered Direct Offering in October 2025 was agreed upon for gross proceeds of approximately $2.5 million.

The company has been actively engaging in business development discussions, which represent potential future revenue streams contingent on external partnerships.

• Potential upfront and milestone payments from strategic licensing deals for the TROP-2 ADC program and monetization of non-core assets.

Future revenue from commercialization remains theoretical at this stage, as the pipeline is pre-commercial.

• Future royalties and product sales from commercialized ADC or nomacopan therapies.

Short-term funding has been secured through various debt instruments, which are liabilities but represent cash inflows for operations.

Here's a quick look at the debt instruments and related financing activity in 2025:

Financing Instrument/Event	Date/Period	Associated Financial Amount
August 2025 Note Purchase Agreements (Gross Purchase Price)	August 2025	$3.0 million
August 2025 Note Purchase Agreements (Aggregate Principal Amount)	August 2025	$3.8 million
August 2025 Private Placement (Aggregate Principal Amount)	August 2025	$2,826,250
August 2025 Private Placement (Purchase Price)	August 2025	$2,261,000
Convertible Notes (Balance Sheet as of Q3 2025)	Q3 2025	$0.7 million
Notes Payable (Related Party, Balance Sheet as of Q3 2025)	Q3 2025	$1.3 million

The balance sheet as of September 30, 2025, also listed $198k in notes payable to third parties.