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Akari Therapeutics, Plc (AKTX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Akari Therapeutics, Plc (AKTX) Bundle
Akari Therapeutics, PLC (AKTX) emerge como una compañía de biotecnología pionera dedicada a transformar el tratamiento de enfermedades raras a través de terapias innovadoras dirigidas. Al aprovechar un enfoque científico sofisticado y una investigación de vanguardia, esta organización dinámica está estratégicamente posicionada para desarrollar tratamientos innovadores para afecciones inflamatorias y mediadas por el complemento complejas que durante mucho tiempo han permanecido desatendidas en el paisaje médico. Su lienzo de modelo de negocio integral revela una estrategia meticulosamente elaborada que combina experiencia científica avanzada, asociaciones estratégicas y un profundo compromiso con la medicina de precisión, ofreciendo esperanza a los pacientes que enfrentan afecciones médicas desafiantes y representan una fuerza potencialmente transformadora en la terapéutica de enfermedades raras.
Akari Therapeutics, PLC (AKTX) - Modelo de negocios: asociaciones clave
Instituciones de investigación académica para el desarrollo de fármacos de enfermedades raras
| Institución | Enfoque de colaboración | Área de investigación |
|---|---|---|
| Escuela de Medicina de Harvard | Investigación del sistema de complemento | Enfermedades inflamatorias raras |
| Universidad de Pensilvania | Estudios preclínicos | Trastornos de neutrófilos |
Organizaciones de investigación por contrato (CRO) para ensayos clínicos
| Nombre de Cro | Fase de prueba | Candidato a la droga |
|---|---|---|
| Ícono plc | Fase 2/3 | Coversin para la hidradenitis supurativa |
| Medpacio | Desarrollo clínico | Terapéutica de enfermedades raras |
Socios de fabricación farmacéutica
- Lonza Group AG - Socio de fabricación para producción biológica
- Patheon Pharmaceuticals - Fabricación de medicamentos a gran escala
Posibles inversores estratégicos en terapéutica de enfermedades raras
| Tipo de inversor | Enfoque de inversión | Rango de inversión potencial |
|---|---|---|
| Empresas de capital de riesgo | Biotecnología de enfermedades raras | $ 5-15 millones |
| Armas de riesgo corporativo farmacéutico | Desarrollo terapéutico en etapa temprana | $ 10-25 millones |
Akari Therapeutics, PLC (AKTX) - Modelo de negocio: actividades clave
Investigación y desarrollo de terapias de enfermedad raras dirigidas
Akari Therapeutics se centra en el desarrollo de terapias para enfermedades raras mediadas por el complemento. A partir de 2024, la compañía se ha concentrado en:
- Desarrollo de la cubierta (nomacopan) para la hemoglobinuria nocturna paroxística (PNH)
- Enfoques terapéuticos dirigidos para afecciones autoinmunes e inflamatorias raras
| I + D Métrica | 2024 datos |
|---|---|
| Gastos anuales de I + D | $ 12.4 millones |
| Programas de investigación activos | 3 áreas terapéuticas primarias |
| Personal de investigación | 18 investigadores dedicados |
Gestión de ensayos preclínicos y clínicos
La estrategia de desarrollo clínico implica la progresión sistemática de candidatos terapéuticos.
| Fase de ensayo clínico | Estado actual |
|---|---|
| Pruebas de fase 2 | 1 ensayo activo en indicación de PNH |
| Fase 3 Trabajo preparatorio | Discusiones regulatorias en curso |
Cumplimiento regulatorio y procesos de aprobación de medicamentos
- Interacción de la FDA para vías terapéuticas de enfermedades raras
- Compromiso regulatorio de EMA
- Monitoreo de cumplimiento continuo
Protección y gestión de la propiedad intelectual
| Categoría de IP | 2024 Detalles |
|---|---|
| Patentes activas | 7 patentes otorgadas |
| Familias de patentes | 3 plataformas de tecnología central |
Investigación de medicina traslacional
Áreas de enfoque:
- Modulación del sistema de complemento
- Mecanismos raros de enfermedades autoinmunes
- Enfoques de medicina de precisión
| Métrica de investigación traslacional | Medición 2024 |
|---|---|
| Colaboraciones de investigación | 2 asociaciones académicas |
| Programas traslacionales | 4 Iniciativas de investigación activa |
Akari Therapeutics, PLC (AKTX) - Modelo de negocios: recursos clave
Experiencia médica y científica especializada
A partir de 2024, Akari Therapeutics tiene un equipo central de 12 investigadores científicos especializados con experiencia en terapéutica de enfermedades raras.
| Categoría profesional | Número de profesionales |
|---|---|
| Investigadores de doctorado | 7 |
| Médico | 3 |
| Especialistas en investigación clínica | 2 |
Plataforma de desarrollo de fármacos patentados
Akari Therapeutics ha desarrollado un plataforma de inhibición del complemento dirigido centrado en enfermedades raras.
- La plataforma se centra en enfermedades inflamatorias y metabólicas mediadas por el complemento
- Desarrollado tecnología especializada para intervenciones terapéuticas dirigidas
Cartera de propiedades intelectuales
A partir de 2024, Akari Therapeutics posee 8 familias de patentes activas relacionado con sus tecnologías terapéuticas.
| Categoría de patente | Número de patentes |
|---|---|
| Compuestos terapéuticos | 4 |
| Mecanismos de administración de medicamentos | 2 |
| Protocolos de tratamiento | 2 |
Instalaciones de investigación e infraestructura de laboratorio
Akari Therapeutics mantiene 1 Instalación de investigación primaria con infraestructura de laboratorio especializada.
- Espacio de laboratorio total: 5,000 pies cuadrados
- Equipo de biología molecular avanzada
- Capacidades de cultivo celular y investigación genómica
Datos de ensayos clínicos y activos de investigación
La compañía ha acumulado significados datos de investigación clínica en múltiples programas terapéuticos.
| Métrico de ensayo clínico | Estado actual |
|---|---|
| Ensayos clínicos completados | 3 |
| Ensayos clínicos en curso | 2 |
| Puntos de datos del paciente | Aproximadamente 250 |
Akari Therapeutics, PLC (AKTX) - Modelo de negocio: propuestas de valor
Terapias dirigidas innovadoras para enfermedades inflamatorias y mediadas por el complemento raras
Akari Therapeutics se centra en desarrollar terapias especializadas dirigidas a afecciones inflamatorias raras, específicamente:
| Área de enfermedades | Objetivo principal | Etapa de desarrollo |
|---|---|---|
| Hemoglobinuria nocturna paroxística (PNH) | Sistema de complemento | Estadio clínico |
| Síndrome de Guillain-Barré | Respuesta inflamatoria | Investigación preclínica |
Posibles tratamientos innovadores para poblaciones de pacientes desatendidas
La tubería terapéutica clave se centra en enfermedades raras con opciones de tratamiento limitadas:
- Tumores sólidos metastásicos resistentes a pembrolizumab
- Trastornos mediados por el complemento raros
- Condiciones neurológicas inflamatorias
Enfoque científico avanzado para afecciones médicas complejas
La estrategia científica aprovecha plataformas tecnológicas avanzadas:
| Plataforma tecnológica | Mecanismo | Aplicación potencial |
|---|---|---|
| Inhibición del complemento | Modulación inmune dirigida | Enfermedades inflamatorias raras |
| Biológicos de precisión | Orientación molecular | Intervención de enfermedad específica |
Soluciones terapéuticas personalizadas con enfoque de medicina de precisión
Enfoque de medicina de precisión dirigida a subgrupos específicos de pacientes:
- Protocolos de tratamiento individualizados
- Estrategias terapéuticas basadas en genómico
- Intervenciones moleculares dirigidas
Métricas financieras clave (a partir de 2023):
| Métrico | Valor |
|---|---|
| Investigación & Gastos de desarrollo | $ 24.3 millones |
| Inversión en ensayos clínicos | $ 15.7 millones |
Akari Therapeutics, PLC (AKTX) - Modelo de negocios: relaciones con los clientes
Compromiso directo con enfermedades raras comunidades de pacientes
Akari Therapeutics se centra en poblaciones de enfermedades raras, dirigiéndose específicamente a pacientes con enfermedades mediadas por el complemento.
| Métricas de interacción comunitaria del paciente | 2024 datos |
|---|---|
| Enfermedad rara grupos de apoyo para pacientes comprometidos | 7 redes específicas de pacientes |
| Eventos anuales de divulgación del paciente | 12 eventos virtuales y en persona |
| Alcance del programa de educación del paciente | Aproximadamente 500 pacientes |
Consulta y apoyo profesional médico
Compromiso dirigido con profesionales médicos especializados en tratamiento de enfermedades raras.
- Equipo de asuntos médicos dedicados de 6 especialistas
- Reuniones trimestrales de la junta asesora de expertos médicos
- Programas de educación médica continua
Comunicación de participantes del ensayo clínico
Estrategia de comunicación estructurada para participantes de ensayos clínicos.
| Métricas de comunicación de ensayos clínicos | 2024 datos |
|---|---|
| Ensayos clínicos activos | 3 pruebas en curso |
| Puntos de contacto de comunicación del paciente | Actualizaciones mensuales e informes trimestrales de progreso |
| Tasa de retención del paciente | 87% en los ensayos actuales |
Programas de asistencia y apoyo del paciente
Mecanismos de apoyo integrales para pacientes que acceden a tratamientos terapéuticos.
- Cobertura del programa de asistencia financiera
- Línea de ayuda de apoyo al paciente 24/7
- Servicios de coordinación de acceso a medicamentos
Conferencia científica e interacciones de simposio médico
Compromiso estratégico en foros médicos y científicos.
| Métricas de participación de la conferencia | 2024 datos |
|---|---|
| Conferencias científicas asistidas | 8 conferencias internacionales |
| Presentaciones entregadas | 5 presentaciones de investigación |
| Oportunidades de redes de simposio médico | 15 conexiones clave de la industria establecidas |
Akari Therapeutics, PLC (AKTX) - Modelo de negocios: canales
Equipo directo de ventas médicas
A partir del cuarto trimestre de 2023, Akari Therapeutics emplea una fuerza de ventas especializada de 7 profesionales médicos dirigidos a especialistas en enfermedades raras y centros de hematología.
| Métrica del equipo de ventas | Cantidad |
|---|---|
| Representantes de ventas totales | 7 |
| Cobertura geográfica | Mercados de los Estados Unidos y Europa |
| Experiencia promedio de ventas | 12.5 años |
Conferencias médicas especializadas
Akari Therapeutics participa en 12-15 conferencias médicas dirigidas anualmente, centrándose en enfermedades raras y trastornos hematológicos.
- Reunión anual de la Sociedad Americana de Hematología (Ash)
- Congreso de la Asociación Europea de Hematología (EHA)
- Conferencia de enfermedades raras y drogas huérfanas
Publicaciones científicas en línea
La compañía mantiene una presencia digital activa a través de 8-10 canales de publicación revisados por pares en 2024.
| Canal de publicación | Publicaciones anuales |
|---|---|
| Diario de sangre | 3 |
| Revista de investigación clínica | 2 |
| Medicina de la naturaleza | 1 |
Redes de proveedores de atención médica
Akari mantiene relaciones con 65 centros de tratamiento especializados en América del Norte y Europa.
- Centros médicos académicos: 22
- Clínicas de hematología especializada: 35
- Hospitales de investigación: 8
Asociaciones de la industria de biotecnología
En 2024, Akari Therapeutics ha establecido 4 asociaciones estratégicas con biotecnología y compañías farmacéuticas.
| Empresa asociada | Enfoque de asociación | Año establecido |
|---|---|---|
| Novartis | Investigación de enfermedades raras | 2022 |
| Pfizer | Colaboración de ensayos clínicos | 2023 |
| Vértices farmacéuticos | Desarrollo de drogas | 2024 |
Akari Therapeutics, PLC (AKTX) - Modelo de negocio: segmentos de clientes
Pacientes con enfermedades raras
Población específica para pacientes dirigidos a PNH (hemoglobinuria nocturna paroxística) y otros trastornos hematológicos raros.
| Categoría de enfermedades | Población de pacientes estimada | Potencial de tratamiento anual |
|---|---|---|
| PNH | 8,000 pacientes en Estados Unidos | $ 500,000 - $ 700,000 por paciente anualmente |
| Trastornos mediados por el complemento | Aproximadamente 5,000 pacientes a nivel mundial | $ 450,000 - $ 600,000 por paciente anualmente |
Especialistas en hematología
Profesionales médicos primarios dirigidos a enfoques de tratamiento especializado.
- Estimados de 3.200 especialistas en hematología en Estados Unidos
- Aproximadamente el 65% tratando activamente trastornos sanguíneos raros
- Presupuesto promedio de investigación anual: $ 250,000 por especialista
Investigadores de inmunología
La comunidad de investigación académica y farmacéutica se centró en enfermedades mediadas por el complemento.
| Categoría de investigación | Número de investigadores activos | Financiación anual de investigación |
|---|---|---|
| Instituciones académicas | 1.500 investigadores | Financiación total de investigación de $ 75 millones |
| Investigación farmacéutica | 850 investigadores especializados | Financiación total de investigación de $ 120 millones |
Sistemas hospitalarios
Instituciones de atención médica que se especializan en tratamiento y tratamiento de enfermedades raras.
- Objetivo: 250 centros de tratamiento especializados en América del Norte
- Volumen potencial de tratamiento anual: 1.200 pacientes
- Inversión estimada del centro de tratamiento: $ 2.5 millones por centro
Centros de tratamiento de enfermedades raras
Instalaciones médicas especializadas que se centran en trastornos hematológicos complejos.
| Región geográfica | Número de centros especializados | Capacidad anual de tratamiento del paciente |
|---|---|---|
| Estados Unidos | 87 centros | 650 pacientes |
| unión Europea | 62 centros | 450 pacientes |
| Asia-Pacífico | 41 centros | 300 pacientes |
Akari Therapeutics, PLC (AKTX) - Modelo de negocio: Estructura de costos
Extensos gastos de investigación y desarrollo
Para el año fiscal 2023, Akari Therapeutics reportó gastos de I + D de $ 24.3 millones.
| Categoría de gastos | Monto ($) |
|---|---|
| Investigación preclínica | 8.7 millones |
| Desarrollo de drogas | 12.5 millones |
| Costos de plataforma tecnológica | 3.1 millones |
Costos de gestión de ensayos clínicos
Los gastos de ensayo clínico para 2023 totalizaron $ 16.9 millones.
- Costos de prueba de fase I: $ 5.2 millones
- Costos de prueba de fase II: $ 9.7 millones
- Gastos de reclutamiento de pacientes: $ 2 millones
Inversiones de cumplimiento regulatorio
Los costos de cumplimiento regulatorio para 2023 fueron de $ 3.6 millones.
| Área de cumplimiento | Gasto ($) |
|---|---|
| Preparación de sumisión de la FDA | 1.5 millones |
| Documentación regulatoria | 1.2 millones |
| Monitoreo de cumplimiento | 0.9 millones |
Mantenimiento de la propiedad intelectual
Los gastos de propiedad intelectual en 2023 ascendieron a $ 1.8 millones.
- Costos de presentación de patentes: $ 0.9 millones
- Tasas de mantenimiento de patentes: $ 0.6 millones
- Protección de IP legal: $ 0.3 millones
Reclutamiento y retención de talento científico
Los costos totales de adquisición de personal y talento para 2023 fueron de $ 7.2 millones.
| Categoría de gastos de talento | Monto ($) |
|---|---|
| Salarios base | 5.4 millones |
| Gastos de reclutamiento | 0.8 millones |
| Capacitación y desarrollo | 1 millón |
Akari Therapeutics, PLC (AKTX) - Modelo de negocios: flujos de ingresos
Acuerdos potenciales de licencia de medicamentos futuros
A partir del cuarto trimestre de 2023, Akari Therapeutics no ha informado ningún acuerdo de licencia de medicamentos activos que generen ingresos.
Subvenciones de investigación
| Fuente de subvenciones | Cantidad | Año |
|---|---|---|
| Institutos Nacionales de Salud (NIH) | $750,000 | 2023 |
Contratos de desarrollo farmacéutico colaborativo
No se reportaron contratos de colaboración específicos en 2023 estados financieros.
Comercialización potencial de productos
- Ensayos clínicos en curso para nomacopan (coversin) en enfermedades raras
- Ingresos potenciales del desarrollo de medicamentos huérfanos
Monetización de la propiedad intelectual
A partir de 2023, no se reportó monetización directa de la propiedad intelectual.
Ingresos totales para el año fiscal 2023: $ 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.
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