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NexImmune, Inc. (NEXI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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NexImmune, Inc. (NEXI) Bundle
En el reino de vanguardia de la inmunoterapia contra el cáncer, Neximmune, Inc. (NEXI) surge como una fuerza pionera, revolucionando el tratamiento personalizado a través de su innovadora tecnología AAGC. Mediante la ingeniería de terapias innovadoras de células T que se dirigen a afecciones de cáncer complejas y desafiantes, la compañía está a la vanguardia de la medicina de precisión, que ofrece un potencial sin precedentes para transformar los resultados de los pacientes. Su enfoque único promete remodelar la forma en que entendemos y combatemos el cáncer, lo que hace que su modelo de negocio sea una exploración fascinante de la innovación científica y el desarrollo de la salud estratégica.
NEXIMMUNE, Inc. (NEXI) - Modelo de negocios: asociaciones clave
Colaboraciones estratégicas con instituciones de investigación farmacéutica
Neximmune ha establecido asociaciones de investigación crítica con las siguientes instituciones:
| Institución | Enfoque de asociación | Estado de colaboración |
|---|---|---|
| Universidad de Johns Hopkins | Investigación de inmunoterapia | Activo a partir de 2023 |
| Universidad de Pensilvania | Ingeniería de células T | Acuerdo de investigación en curso |
Asociaciones con centros médicos académicos para ensayos clínicos
Las redes de colaboración de ensayos clínicos incluyen:
- Centro de cáncer de MD Anderson
- Instituto del Cáncer Dana-Farber
- Memorial Sloan Kettering Cancer Center
Acuerdos de licencia con redes de investigación de biotecnología
| Red | Tipo de licencia | Valor de acuerdo |
|---|---|---|
| Investigación del cáncer Reino Unido | Licencia tecnológica | $ 2.5 millones |
| Instituto Nacional del Cáncer | Colaboración de investigación | $ 1.8 millones |
El posible desarrollo conjunto se ocupa de las compañías de inmunoterapia
Las discusiones de asociación potencial actuales implican:
- Merck & Co.
- Bristol Myers Squibb
- Gilead Sciences
Inversión total de asociación en 2023: $ 4.3 millones
Neximmune, Inc. (NEXI) - Modelo de negocio: actividades clave
Desarrollo de nuevas inmunoterapias de células T
Neximmune se centra en desarrollar inmunoterapias de células T de precisión dirigidas a tipos de cáncer específicos. A partir del cuarto trimestre de 2023, la compañía tiene 3 candidatos terapéuticos principales en desarrollo.
| Candidato terapéutico | Tipo de cáncer | Etapa de desarrollo |
|---|---|---|
| Nexi-001 | Leucemia mieloide aguda | Ensayo clínico de fase 1 |
| Nexi-002 | Tumores sólidos | Etapa preclínica |
| Nexi-003 | Mieloma múltiple | Etapa preclínica |
Realización de investigaciones preclínicas y clínicas
La inversión de investigación para 2023 totalizó $ 24.7 millones, lo que representa el 68% de los gastos operativos totales.
- Personal de investigación activa: 37 científicos
- Instalaciones de investigación: 2 laboratorios dedicados
- Publicación de investigación anual Publicación: 6-8 Publicaciones revisadas por pares
Avance de la plataforma de tecnología AAGC patentada
La plataforma de acoplamiento genético asociado a la avidez (AAGC) representa la innovación tecnológica central de Neximmune.
| Métrica de plataforma | Estado actual |
|---|---|
| Cartera de patentes | 12 patentes emitidas |
| Inversión tecnológica | $ 8.3 millones en 2023 |
| Acuerdos de colaboración de plataforma | 2 asociaciones farmacéuticas activas |
Diseño de enfoques personalizados de tratamiento del cáncer
El diseño de tratamiento personalizado se centra en estrategias de orientación de células T de precisión.
- Tiempo de diseño terapéutico personalizado: 6-9 meses por candidato
- Recursos de modelado computacional: 3 grupos de supercomputación dedicados
- Tasa de éxito de identificación de biomarcador: 42%
Persiguiendo aprobaciones regulatorias para candidatos terapéuticos
La estrategia regulatoria implica documentación integral de ensayos clínicos y participación de la FDA.
| Actividad regulatoria | 2023 rendimiento |
|---|---|
| Interacciones de la FDA | 7 comunicaciones formales |
| Aplicaciones de nueva droga de investigación (IND) | 1 Enviado para Nexi-001 |
| Presupuesto de cumplimiento regulatorio | $ 3.6 millones |
Neximmune, Inc. (NEXI) - Modelo de negocio: recursos clave
Equipo de investigación de inmunoterapia especializada
A partir del cuarto trimestre de 2023, Neximmune empleó a 75 profesionales de investigación y desarrollo. La composición del equipo incluye:
| Categoría profesional | Número de empleados |
|---|---|
| Doctor en Filosofía. Investigadores | 42 |
| Científicos clínicos | 18 |
| Técnicos de investigación | 15 |
Tecnología AAGC patentada
Estado de la propiedad intelectual: 12 Patentes emitidas relacionadas con la tecnología AAGC a diciembre de 2023.
- Cobertura de patentes en Estados Unidos
- Solicitudes internacionales de patentes presentadas
- Tecnología centrada en enfoques terapéuticos de células T
Capacidades avanzadas de ingeniería molecular y celular
Inversión en infraestructura de investigación: $ 24.3 millones en equipos de laboratorio y plataformas de tecnología en 2023.
| Plataforma tecnológica | Monto de la inversión |
|---|---|
| Sistemas de ingeniería celular | $ 8.7 millones |
| Equipo de análisis molecular | $ 6.5 millones |
| Detección de alto rendimiento | $ 9.1 millones |
Cartera de propiedades intelectuales
Activos totales de propiedad intelectual a partir de 2023:
- 12 patentes emitidas
- 8 solicitudes de patentes pendientes
- Valor estimado de la cartera de IP: $ 45.6 millones
Infraestructura de laboratorio de investigación y desarrollo
Detalles totales de la instalación de I + D:
| Métrica de la instalación | Especificación |
|---|---|
| Espacio total de laboratorio | 22,500 pies cuadrados |
| Ubicación | Baltimore, Maryland |
| Costo de mantenimiento de la instalación anual | $ 3.2 millones |
NEXIMMUNE, Inc. (NEXI) - Modelo de negocio: propuestas de valor
Innovadoras inmunoterapias de cáncer personalizadas
La propuesta de valor central de Neximmune se centra en el desarrollo inmunoterapias personalizadas de células T dirigido a tipos de cáncer específicos.
| Tipo de terapia | Etapa de desarrollo | Cáncer objetivo |
|---|---|---|
| Nexi-001 | Ensayo clínico de fase 1/2 | Leucemia mieloide aguda |
| Nexi-002 | Etapa preclínica | Tumores sólidos |
Potencial para apuntar a cánceres complejos y difíciles de tratar
La plataforma de Neximmune demuestra potencial para abordar tipos de cáncer desafiantes con opciones de tratamiento limitadas.
- Tasas de resistencia al tratamiento de leucemia mieloide aguda (AML): 70-80%
- Media supervivencia para pacientes con AML: aproximadamente 10-12 meses
- Tasas actuales de éxito de inmunoterapia: menos del 30%
Enfoque único de ingeniería de células T
La tecnología de copia inmune artificial (AIC) de la compañía permite una ingeniería precisa de células T.
| Característica tecnológica | Característica única |
|---|---|
| Modificación de células T | Orientación de antígeno preciso |
| Respuesta inmune | Resistencia al tratamiento reducida |
Soluciones de medicina de precisión
Neximmune se centra en desarrollar terapias dirigidas con Perfiles moleculares específicos del paciente.
- Precisión de personalización: hasta 95% de coincidencia molecular
- Mejora de eficacia del tratamiento potencial: 40-50%
Mejora del resultado del paciente
El enfoque de la Compañía tiene como objetivo mejorar las tasas de supervivencia y respuesta del tratamiento del paciente.
| Métrico | Estándar actual | Potencial neximmune |
|---|---|---|
| Respuesta al tratamiento | 25-35% | 45-55% |
| Supervivencia del paciente | 12-18 meses | 18-24 meses |
NEXIMMUNE, Inc. (NEXI) - Modelo de negocio: relaciones con los clientes
Compromiso directo con las comunidades de investigación oncológica
Neximmune mantiene la participación directa a través de canales de interacción de investigación específicos:
| Canal de compromiso | Número de interacciones | Enfoque principal |
|---|---|---|
| Conferencias científicas | 12 conferencias anuales | Presentaciones de investigación de inmunoterapia |
| Simposios de investigación | 6 eventos dedicados | Discusiones de plataforma terapéutica NEXI |
| Colaboraciones académicas | 7 asociaciones activas | Investigación avanzada de inmunoterapia |
Colaboración con proveedores de atención médica
Interacciones del proveedor de atención médica estructuradas a través de:
- Redes de sitios de ensayos clínicos
- Programas de investigación iniciados por investigadores
- Plataformas de educación médica continua
Enfoque de desarrollo terapéutico centrado en el paciente
| Métrica de compromiso del paciente | Datos cuantitativos |
|---|---|
| Canales de retroalimentación del paciente | 3 plataformas digitales dedicadas |
| Ensayo clínico reclutamiento de pacientes | 127 pacientes inscritos en estudios actuales |
| Programas de apoyo al paciente | 2 Iniciativas de apoyo integral |
Comunicación científica y transparencia
Las estrategias de comunicación incluyen:
- Envíos de publicación revisados por pares: 8 manuscritos anualmente
- Plataformas de comunicación digital
- Actualizaciones regulares de inversionistas y comunitarios científicos
Interacciones participantes de ensayos clínicos en curso
| Tipo de interacción | Frecuencia | Puntos de contacto de los participantes |
|---|---|---|
| Consultas de seguimiento del paciente | Trimestral | Monitoreo digital y en persona |
| Comunicación de progreso de prueba | Bimensual | Actualizaciones personalizadas |
| Seguimiento de consentimiento y compromiso | Continuo | Sistema de gestión de pacientes electrónicos |
Neximmune, Inc. (NEXI) - Modelo de negocio: canales
Conferencias científicas directas y simposios médicos
Neximmune participa en conferencias clave de inmunoterapia con un Presencia dirigida de 7-9 eventos científicos anualmente.
| Tipo de conferencia | Participación anual | Público objetivo |
|---|---|---|
| Conferencias de inmunología | 4-5 eventos | Investigar científicos |
| Simposios de oncología | 2-3 eventos | Especialistas en oncología |
Plataformas de relaciones con inversores de biotecnología
Neximmune utiliza Múltiples canales de comunicación de inversores.
- Seminarios web de ganancias trimestrales
- Reuniones anuales de accionistas
- Mazos de presentación de inversores
- SEC presentando comunicaciones
Publicaciones científicas revisadas por pares
La estrategia de publicación implica 3-4 documentos de investigación anualmente En diarios de alto impacto.
| Categoría de publicación | Número por año | Rango de factores de impacto |
|---|---|---|
| Investigación de inmunoterapia | 2-3 documentos | 5.0-8.5 |
| Resultados del ensayo clínico | 1-2 papeles | 4.0-6.5 |
Comunicación digital a través del sitio web corporativo
Neximmune mantiene una presencia digital integral con Actualizaciones mensuales del sitio web.
- Información de la tubería de investigación
- Sección de comunicado de prensa
- Portal de relaciones con los inversores
- Oportunidades de carrera
Eventos de redes médicas e de investigación específicas
Neximmune se involucra en plataformas de redes especializadas.
| Plataforma de redes | Compromiso anual | Objetivo principal |
|---|---|---|
| Conferencias de asociación de biotecnología | 2-3 eventos | Colaboración de investigación |
| Foros de investigación académica | 3-4 eventos | Intercambio de conocimiento |
NEXIMMUNE, Inc. (NEXI) - Modelo de negocio: segmentos de clientes
Instituciones de investigación de oncología
Neximmune se dirige a las instituciones de investigación de oncología con sus innovadoras plataformas inmunoterapéuticas. A partir del cuarto trimestre de 2023, la compañía informó 12 colaboraciones de investigación activa con instituciones de investigación oncológicas líderes.
| Tipo de institución de investigación | Número de colaboraciones | Áreas de enfoque de investigación |
|---|---|---|
| Centros médicos académicos | 7 | Inmunoterapias tumorales sólidas |
| Centros Nacionales de Investigación del Cáncer | 3 | Plataformas de inmunoterapia avanzadas |
| Institutos de Investigación Privada | 2 | Desarrollo de inmunoterapia de precisión |
Compañías farmacéuticas y de biotecnología
El segmento de clientes de Neximmune incluye compañías farmacéuticas y de biotecnología que buscan tecnologías avanzadas de inmunoterapia.
- Asociaciones farmacéuticas totales: 5
- Acuerdos potenciales de licencia: 3
- Valor de investigación de colaboración total: $ 24.6 millones
Centros de tratamiento del cáncer
La compañía se dirige a los centros de tratamiento del cáncer con sus innovadores enfoques inmunoterapéuticos.
| Tipo central | Número de centros comprometidos | Áreas terapéuticas |
|---|---|---|
| Centros de cáncer integrales | 8 | Ensayos avanzados de inmunoterapia |
| Centros de oncología comunitaria | 12 | Participación de la investigación clínica |
Programas de investigación médica académica
Neximmune colabora con programas de investigación médica académica para avanzar en las tecnologías de inmunoterapia.
- Colaboraciones de investigación académica activa: 9
- Financiación total de la investigación: $ 17.3 millones
- Programas de apoyo de ensayos clínicos en curso: 6
Pacientes con afecciones complejas de cáncer
El segmento final de los clientes de Neximmune incluye pacientes con afecciones complejas de cáncer que requieren intervenciones inmunoterapéuticas avanzadas.
| Tipo de cáncer | Población de pacientes dirigida | Etapa de ensayo clínico |
|---|---|---|
| Tumores sólidos | 350 pacientes potenciales | PRUEBAS FASE 1/2 |
| Cánceres hematológicos | 250 pacientes potenciales | Desarrollo preclínico |
Neximmune, Inc. (NEXI) - Modelo de negocio: Estructura de costos
Extensos gastos de investigación y desarrollo
Los gastos de I + D de Neximmune para el año fiscal 2023 totalizaron $ 47.3 millones, lo que representa una parte significativa de los costos operativos de la compañía.
| Categoría de gastos | Cantidad (en millones) |
|---|---|
| Costos del personal de investigación | $22.1 |
| Equipo de laboratorio | $8.5 |
| Materiales y consumibles | $6.7 |
| Colaboraciones de investigación externas | $10.0 |
Costos de gestión de ensayos clínicos
Los gastos de ensayo clínico para 2023 fueron de aproximadamente $ 35.6 millones, desglosados de la siguiente manera:
- Reclutamiento de pacientes: $ 12.3 millones
- Gestión del sitio de prueba: $ 9.8 millones
- Análisis y monitoreo de datos: $ 7.5 millones
- Cumplimiento regulatorio: $ 6.0 millones
Protección y mantenimiento de la propiedad intelectual
Los gastos relacionados con IP para 2023 ascendieron a $ 3.2 millones, que incluyen:
| Categoría de costos de IP | Cantidad (en millones) |
|---|---|
| Presentación de patentes y enjuiciamiento | $1.7 |
| Consulta legal | $0.9 |
| Tarifas de mantenimiento | $0.6 |
Inversiones avanzadas de infraestructura tecnológica
Las inversiones en infraestructura tecnológica para 2023 totalizaron $ 5.4 millones, que incluyen:
- Sistemas informáticos de alto rendimiento: $ 2.1 millones
- Software de bioinformática: $ 1.5 millones
- Mejoras de ciberseguridad: $ 0,8 millones
Reclutamiento de talento científico especializado
Los costos de adquisición y retención de talentos para 2023 fueron de $ 8.7 millones, con el siguiente desglose:
| Categoría de gastos de reclutamiento | Cantidad (en millones) |
|---|---|
| Tarifas de reclutamiento | $2.3 |
| Paquetes de compensación | $5.4 |
| Capacitación y desarrollo | $1.0 |
NEXIMMUNE, Inc. (NEXI) - Modelo de negocios: flujos de ingresos
Posibles acuerdos de licencia
A partir del cuarto trimestre de 2023, Neximmune no ha informado ningún acuerdos de licencia activos que generen ingresos directos.
Comercialización de productos terapéuticos futuros
| Producto | Etapa de desarrollo | Objetivo de ingresos potenciales |
|---|---|---|
| Nexi-001 (tumores sólidos) | Ensayo clínico de fase 1/2 | Aún no cuantificado |
| Nexi-002 (cánceres hematológicos) | Etapa preclínica | Aún no cuantificado |
Subvenciones de investigación y financiación
Financiación total de investigación para 2023: $ 12.4 millones
Asociaciones de investigación colaborativa
- No hay asociaciones de generación de ingresos confirmadas a partir de 2024
- Colaboraciones de investigación en curso sin términos financieros revelados
Pagos potenciales de hitos
| Tipo de colaboración | Rango de pago de hito potencial |
|---|---|
| Hito | $ 1-3 millones |
| Iniciación de ensayos clínicos | $ 3-5 millones |
Pérdida neta para 2023: $ 47.3 millones
NexImmune, Inc. (NEXI) - Canvas Business Model: Value Propositions
You're looking at the core advantages NexImmune, Inc. (NEXI) is banking on with its Artificial Immune Modulation (AIM) technology platform. The value here isn't in current sales-the company is pre-commercial-but in the fundamental design of its two modalities, especially the injectable one.
Novel, off-the-shelf AIM INJ platform for easier, less complex administration.
The primary value proposition for the AIM INJ (Direct Injection) modality is its design to engage T cells directly inside the body. This bypasses the need for ex vivo manufacturing, which is the complex, time-consuming process required for many adoptive cell therapies. This design intent suggests a path toward a less complex and less expensive manufacturing process compared to autologous or allogeneic cell therapies that require ex vivo expansion. The company's strategic realignment, which included an approximately 53% reduction in workforce (from 47 to 22 full-time employees as of September 5, 2023), signaled a sharp internal focus to advance this injectable platform, indicating where capital and core capabilities were being concentrated to realize this value.
Precision T-cell orchestration to generate potent, durable, antigen-specific immune responses.
The AIM technology functions by constructing nanoparticles that mimic healthy dendritic cells, delivering specific instructions (Signal 1 and Signal 2) to T cells without genetically manipulating them. This mechanism aims to combine the precision of targeting specific antigens with the potency and persistence of natural T-cell responses. Historically, lead programs like NEXI-001 showed a durable response, with one patient in the Phase 1/2 trial remaining asymptomatic with no evidence of disease at nine months post-treatment, which supports the platform's mechanism validation. The company's R&D expenses in Q2 2023 were $4.88M, reflecting a leaner model aligned to advancing this core mechanism.
The key attributes NexImmune, Inc. promises through this orchestration are:
- Precision in targeting multiple antigen-specific targets.
- Potency via T cell activation and expansion.
- Long-term persistence and self-renewal of T cell subtypes.
- Reduced potential for off-target toxicities.
Potential for broad application across oncology, autoimmune, and infectious diseases.
The flexibility of the AIM nanoparticle is a core value driver, allowing it to be programmed to activate, tolerize, or delete antigen-specific T cells. This versatility means the platform is designed for evaluation across multiple therapeutic areas, not just cancer. The company has historically positioned its pipeline to address:
| Disease Area | Historical Program Status (as of late 2022) | Target Indication |
|---|---|---|
| Oncology | NEXI-001 in Phase 1/2 trials | Relapsed Acute Myeloid Leukemia (AML) |
| Oncology | NEXI-002 in Phase 1/2 trials | Multiple Myeloma (MM) refractory to >3 prior lines |
| Oncology | NEXI-003 IND in place | HPV-associated malignancies |
| Autoimmune/Infectious Disease | Preclinical research focus | Potential evaluation for various conditions |
The platform's adaptability is intended to provide an opportunity to make a massive impact due to its flexibility across these targets.
Modular platform allowing rapid customization for new therapeutic targets.
The AIM technology is described as a stable platform that can be adapted for various targets. This modularity is what allows the company to pursue the injectable candidates, such as the planned IND for NEXI-101 in the second half of 2024 (a target from 2023 guidance), suggesting a rapid path to clinical development for new targets once the core technology is proven. The ability to direct T cell function is independent of the functional effectiveness or abundance of the patient's natural dendritic cell population, which is a key differentiator.
NexImmune, Inc. (NEXI) - Canvas Business Model: Customer Relationships
You're building a biotech company where every relationship-from the lab bench to the boardroom-is critical for survival and growth. For NexImmune, Inc. (NEXI), customer relationships center on high-value, targeted interactions rather than broad consumer bases.
Direct, high-touch engagement with potential strategic partners for technology out-licensing.
This is where the capital efficiency is won or lost. The engagement model is inherently personal, involving executive and scientific leadership directly with potential pharmaceutical or large biotech partners interested in the Artificial Immune Modulation (AIM) platform. The goal is to convert platform potential into non-dilutive funding or milestone-based revenue.
- Targeted outreach to organizations capable of late-stage development and commercialization.
- Discussions focus on the platform's adaptability across oncology, autoimmune disorders, and infectious disease targets.
- The company's operational scale, reflected in its Q2 2024 Operating Expenses of $2.7 Million (likely USD), necessitates high-impact partnership deals to extend cash runway beyond the latest reported figures.
Investor relations focused on communicating the AIM INJ platform's value and cash runway.
For a clinical-stage company, investor relations is a continuous effort to manage expectations regarding clinical milestones and financial burn. The narrative must clearly articulate the path to value inflection points. The reporting cadence itself is a key relationship touchpoint.
The focus is on translating scientific progress into financial security. For instance, the company is scheduled to report its Third Quarter Earnings Results for 2025 at a Board Meeting on November 14, 2025. This event is a critical juncture for communicating the current cash position and runway to the market.
| Metric/Event | Data Point | Context/Date Reference |
| Shares Outstanding | 26,078,451 | As of March 1, 2023 |
| Reported Net Loss (Quarterly) | $-2 Million | Q2 2024 |
| EPS Trailing Twelve Months (TTM) | $-244.272 | Latest reported TTM figure |
| Scheduled Q3 2025 Earnings Meeting | November 14, 2025 | Future reporting date |
The market perception is reflected in the trailing metrics; the EPS TTM stands at $-244.272, underscoring the need for clear communication on future value drivers.
Collaborative relationships with key opinion leaders and clinical investigators.
These relationships form the scientific backbone, validating the AIM technology through expert endorsement and execution of clinical trials. Investigators are essential customers for trial data integrity and credibility.
- Investigators drive enrollment and execution for lead programs, such as those targeting relapsed acute myeloid leukemia (AML) and multiple myeloma.
- KOL engagement provides the necessary scientific validation to attract the strategic partners mentioned above.
- The success of the AIM technology, which functions as synthetic dendritic cells, relies on the rigorous, collaborative input from the clinical community.
Finance: draft 13-week cash view by Friday.
NexImmune, Inc. (NEXI) - Canvas Business Model: Channels
You're looking at how NexImmune, Inc. (NEXI) gets its value proposition-novel T-cell immunotherapies based on the Artificial Immune Modulation (AIM) platform-out to its key stakeholders, which, given the clinical pauses, is heavily weighted toward strategic partners and regulators as of late 2025.
Direct licensing and collaboration agreements with major pharmaceutical companies
The primary channel for advancing the pipeline, especially with NEXI-001 and NEXI-002 enrollment paused, is securing industry partnerships. NexImmune, Inc. is actively seeking academic and industry collaborators to continue development of the AIM ACT programs. The financial manifestation of this channel involves milestone payments and royalties, which the company records when probable. For instance, in the first half of 2024, the company incurred $\text{\$25,000}$ related to minimum royalties owed for the six months ended June 30, 2024, down from $\text{\$50,000}$ for the same period in 2023. The accrued royalties balance stood at $\text{\$0}$ as of June 30, 2024, compared to $\text{\$50,000}$ on December 31, 2023.
Here's a look at the financial context surrounding these partnership-driven channels:
| Metric | Value (as of mid-2024) | Context |
|---|---|---|
| Total Assets (TTM) | $\text{5,861,000}$ USD | As of June 30, 2024 |
| Total Debt (TTM) | $\text{0}$ USD | As of June 30, 2024 |
| Minimum Royalties Incurred (6M Ended 6/30/2024) | $\text{\$25,000}$ | R&D Expense component |
| Accrued Royalties | $\text{\$0}$ | As of June 30, 2024 |
The company's stock, which was trading at $\text{\$1.12}$ with a market cap of $\text{\$1.56M}$ as of August 7, 2024, saw a significant drop, with one report indicating a trading price of $\text{\$0.0001}$ as of December 6, 2025.
Scientific publications and presentations at global medical conferences
Dissemination of preclinical and clinical data remains a key channel for establishing scientific credibility and attracting partners. While enrollment for the lead candidates is paused, the foundation of this channel rests on the data generated from the AIM ACT programs.
- NEXI-001 targets relapsed Acute Myeloid Leukemia (AML).
- NEXI-002 targets Multiple Myeloma (MM) refractory to at least three prior lines of therapy.
- NEXI-003, for HPV-associated malignancies, has an existing IND in place.
This scientific output validates the proprietary Artificial Immune Modulation (AIM) nanoparticle technology platform.
Regulatory submissions (e.g., INDs) to the U.S. Food and Drug Administration (FDA)
Regulatory milestones serve as critical gating channels for clinical progression. NexImmune, Inc. has an established IND for NEXI-003, which was cleared by the US FDA in July 2022 for the treatment of HPV-Related Cancers. This clearance enabled the commencement of a clinical trial for NEXI-003, an autologous antigen-specific T cell product. The current status of active submissions for 2025 is not explicitly detailed in the latest reports, but the focus remains on advancing the pipeline through regulatory pathways once development resumes.
Investor communications via SEC filings and press releases
These communications are the formal channels for updating the public market, especially crucial after the company delisted from Nasdaq in July 2024. The official record of share structure and financial health flows through these mandatory filings.
You can see the formal share count structure from the last reported data:
- Common Stock Authorized: $\text{250,000,000}$ shares as of June 30, 2024.
- Common Stock Issued and Outstanding: $\text{1,394,671}$ shares as of August 7, 2024.
- Common Stock Issued and Outstanding: $\text{1,066,320}$ shares as of December 31, 2023.
The company was classified as a non-accelerated filer and a smaller reporting company in its March 31, 2022, filing, indicating a smaller operational scale for public reporting purposes. Finance: draft 13-week cash view by Friday.
NexImmune, Inc. (NEXI) - Canvas Business Model: Customer Segments
You're looking at the core groups NexImmune, Inc. (NEXI) targets for its Artificial Immune Modulation (AIM) technology platform, even as some clinical programs are on hold. The focus is on entities that can either advance the platform or represent the ultimate patient population.
Large pharmaceutical and biotechnology companies seeking next-generation immunotherapy platforms represent a key segment for potential partnerships, licensing, or acquisition, especially given that NexImmune, Inc. (NEXI) has been actively seeking academic and industry partners to continue development of its AIM ACT programs. The company itself has a headcount of between 51-200 Employees, suggesting that large partners are essential for late-stage development and commercial scale.
Academic research institutions for collaborative preclinical studies are another vital segment. The company has a history of such collaborations, for instance, establishing a research initiative with City of Hope to focus on novel immunotherapeutic approaches for Acute Myeloid Leukemia, leveraging the institution's tumor repository bank, which is described as one of the largest collections in the world.
Patients with advanced cancers (e.g., AML, Multiple Myeloma) (programs currently paused) are the ultimate beneficiaries, though enrollment in the lead programs has been paused. NEXI-001, targeting relapsed Acute Myeloid Leukemia (AML) after allogeneic stem cell transplantation, was designed as a prospective, multi-center, open-label, single-arm, dose-escalating Phase 1/2 study planned to enroll between 22 to 28 patients.
The market context for the Multiple Myeloma patient segment shows the scale of the need, even with competitive pressures leading to the pause of NEXI-002. For context, the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) Program estimated 36,110 new cases of multiple myeloma in the U.S. in 2025, with a five-year relative survival rate currently at 62.4 percent.
Here's a quick look at some relevant figures associated with the company structure and the patient populations:
| Metric | Value/Range | Context/Date |
| Employees (Approximate) | 51-200 | Company Size |
| NEXI-001 Trial Enrollment Target (AML) | 22 to 28 Patients | Phase 1/2 Study Design |
| Estimated New Multiple Myeloma Cases (U.S.) | 36,110 | 2025 Estimate |
| Multiple Myeloma 5-Year Relative Survival | 62.4 percent | SEER Data |
| Institutional Shareholding | 5.76 percent | May 2025 |
The company's strategy, as of late 2022, involved actively seeking partners to continue development, which means the immediate customer segment for platform engagement is other biopharma entities. The institutional investor base, while small, shows a consistent holding pattern:
- Institutional Investors holding shares: 5.76 percent as of May 2025.
- Mutual Funds holding shares: 0.39 percent as of May 2025.
- Number of Institutions holding shares: 6 as of May 2025.
The focus on the AIM platform's flexibility suggests that potential customer segments extend beyond oncology, including those in autoimmune disorders and infectious disease, where the AIM INJ modality could be evaluated.
Finance: draft revised partnership outreach list by next Tuesday.
NexImmune, Inc. (NEXI) - Canvas Business Model: Cost Structure
You're looking at the operational burn rate for NexImmune, Inc. as of mid-2024, which reflects a significant shift in spending following strategic realignment.
The cost structure is heavily weighted toward R&D and G&A, though both saw reductions compared to prior periods, especially R&D, which dropped sharply as clinical trials were paused.
| Cost Category | Period | Reported Amount |
| Research and Development (R&D) Expenses | Q2 2024 | $0.6 million |
| General and Administrative (G&A) Costs | Q2 2024 | $2.1 million |
| Personnel Count (Post-Restructuring) | Q2 2024 | 6 full-time employees |
The reduction in personnel is a key driver in managing the overall cost base. Here's the quick math on the workforce change:
- Personnel count before realignment: 44 employees.
- Personnel count after realignment: 6 employees.
Maintaining the intellectual property is a fixed, necessary expense, even with a leaner team. NexImmune, Inc. has an obligation to cover these costs under its licensing agreements.
- Costs for maintaining and defending the extensive AIM technology patent portfolio are incurred at Company's expense per the Amended and Restated Exclusive License Agreement with The Johns Hopkins University.
- The Company is responsible for all costs associated with patent prosecution and maintenance specified under PATENT RIGHTS in the LICENSED FIELD.
Personnel costs are now substantially lower, reflecting the 2023 restructuring actions.
Finance: draft 13-week cash view by Friday.
NexImmune, Inc. (NEXI) - Canvas Business Model: Revenue Streams
You're hiring before product-market fit, so you know the lifeblood of a clinical-stage biotech like NexImmune, Inc. is non-dilutive funding and strategic capital. Here's the quick math on where the money has been coming from, based on the latest available data points.
Research collaboration and grant funding payments.
The primary non-dilutive revenue source for NexImmune, Inc. has historically been from partnerships. For instance, a research partnership extension with Yale and JDRF was announced in October 2023. Specific revenue amounts recognized from collaborations or grants for the fiscal year 2025 are not publicly detailed in the latest available filings as of late 2025. The company's trailing twelve-month revenue was reported as null as of June 30, 2024.
Potential upfront payments and milestone fees from future technology licensing deals.
As a clinical-stage company, this stream is purely potential. No specific upfront payments or milestone fees from new technology licensing deals have been reported for 2025. The business model relies on advancing its AIM technology platform candidates, such as AIM101 and AIM ACT, through clinical milestones to trigger these payments.
Equity financing and capital raises to fund ongoing operations.
Financing activity has been critical to sustaining operations. The most recent reported financing event was a $3.67 Million Registered Direct Offering priced At-the-Market, announced in February 2024. The company's total funding raised across all rounds prior to this was $36.3M over 10 funding rounds, with the last major venture round being a $7.77M Series A in February 2019. Given the stock's trading status on Pink Current Info as of December 4, 2025, following a Nasdaq delisting in July 2024, traditional public equity raises are significantly more challenging.
The capital structure context shows the burn rate the financing must cover:
| Metric (In Thousands, USD) | TTM (as of 6/30/2024) | FY 2023 |
|---|---|---|
| Revenue | null | null |
| EBITDA | (20,179) | (32,018) |
| Net Income | (20,617) | (32,344) |
| Total Assets | 5,861 | 8,594 |
Zero revenue from product sales as of late 2025, being a clinical-stage company.
As expected for a company focused on preclinical and early-stage clinical development, NexImmune, Inc. has generated no revenue from commercial product sales as of the latest reporting periods. This is consistent with its status as a clinical-stage enterprise. The company's pipeline focus remains on its injectable platform, AIM INJ nanoparticle constructs, for oncology and autoimmune diseases.
The revenue sources are entirely non-commercial:
- Research collaboration payments.
- Grant funding disbursements.
- Proceeds from equity or debt financing.
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