PolyPid Ltd. (PYPD): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Polypid Ltd. (PYPD) emerge como un innovador innovador de biotecnología, revolucionando la administración de fármacos a través de su tecnología de liberación controlada D-Plex de vanguardia. Al cerrar estratégicamente la ingeniería de polímeros avanzados con innovación farmacéutica, la compañía promete transformar paradigmas de tratamiento del paciente, ofreciendo una precisión sin precedentes en la administración de medicamentos en múltiples dominios terapéuticos. Su enfoque único no solo mejora la absorción de fármacos y reduce los efectos secundarios, sino que también los posiciona como un posible cambio de juego en el complejo panorama de la tecnología médica y el desarrollo farmacéutico.

Polypid Ltd. (PYPD) - Modelo de negocios: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

Polypid Ltd. ha establecido asociaciones de investigación clave con las siguientes instituciones académicas y de investigación:

Institución	Enfoque de colaboración	Año de colaboración
Universidad de Tel Aviv	Desarrollo de tecnología de suministro de medicamentos	2019
Centro Médico Hadassah	Validación de investigación clínica	2020

Asociación con fabricantes de dispositivos médicos

Las asociaciones de fabricación de dispositivos médicos de Polypid incluyen:

• Medtronic PLC - Integración del sistema de administración de fármacos
• Boston Scientific Corporation - Investigación de compatibilidad de implantes quirúrgicos

Acuerdos de licencia con compañías de biotecnología

Compañía	Tipo de licencia	Valor de acuerdo
Novartis AG	Licencias de tecnología D-Plex	$ 3.2 millones

Colaboración con organizaciones de investigación clínica

Polypid mantiene asociaciones activas con:

• IQVIA Holdings Inc.
• Parexel International Corporation
• Ícono plc

Posibles alianzas estratégicas en tecnología de suministro de medicamentos

Conversiones continuas de la Alianza de Tecnología Estratégica con:

• Johnson & Innovación de Johnson
• Pfizer Ventures
• Roche Laboratorios de investigación farmacéutica

Polypid Ltd. (PYPD) - Modelo de negocio: actividades clave

Investigación y desarrollo de plataformas controladas de suministro de medicamentos

Polypid Ltd. invirtió $ 12.3 millones en gastos de I + D para el año fiscal 2023. La compañía se centró en desarrollar la plataforma de tecnología PLEX (encapsulación de lípidos de polímero) para la administración controlada de medicamentos.

I + D Métrica	Valor
Gasto de I + D 2023	$ 12.3 millones
Personal de I + D	24 investigadores especializados
Solicitudes de patentes	7 nuevas aplicaciones en 2023

Ensayos clínicos y procesos de aprobación regulatoria

Polypid realizó múltiples ensayos clínicos para su producto principal D-Plex100 dirigido a infecciones del sitio quirúrgico.

• Inscripción de ensayos clínicos de fase 3: 350 pacientes
• Gastos totales de ensayos clínicos en 2023: $ 8.7 millones
• Preparación de envío de la FDA en curso para D-Plex100

Desarrollo de tecnología de polímeros avanzados

La compañía mantiene un equipo de investigación de tecnología de polímeros dedicado con experiencia especializada en ingeniería biomaterial.

Métrica de desarrollo tecnológico	Valor
Tamaño del equipo de tecnología de polímeros	12 ingenieros especializados
Presupuesto de desarrollo tecnológico 2023	$ 5.6 millones

Formulación y optimización de productos farmacéuticos

Polypid se centra en el desarrollo de mecanismos innovadores de suministro de fármacos utilizando su tecnología PLEX patentada.

• Iteraciones de formulación de productos en 2023: 14
• Ciclos de optimización completados: 6
• Áreas terapéuticas dirigidas: infecciones quirúrgicas, curación de heridas

Gestión y protección de la propiedad intelectual

Polypid mantiene una sólida estrategia de propiedad intelectual para proteger sus tecnologías innovadoras.

Métrica de gestión de IP	Valor
Patentes activas totales	23 patentes
Gastos de protección de patentes 2023	$ 1.2 millones
Cobertura de patentes geográficas	Estados Unidos, Europa, Japón

Polypid Ltd. (PYPD) - Modelo de negocio: recursos clave

Tecnología de administración de medicamentos controlado D-Plex patentado

El activo tecnológico central de Polypid es la plataforma de suministro de fármacos controlado D-Plex, que permite mecanismos precisos de liberación farmacéutica.

Atributo tecnológico	Especificación
Protección de patentes	Múltiples patentes emitidas en jurisdicciones de EE. UU. E internacional
Etapa de desarrollo	Fase de desarrollo clínico avanzado
Aplicaciones potenciales	Prevención de infecciones del sitio quirúrgico, administración de medicamentos localizados

Experiencia de investigación científica

Polypid mantiene experiencia especializada en ingeniería de polímeros y sistemas de administración de medicamentos controlados.

• Capacidades avanzadas de diseño de polímeros
• Tecnologías especializadas de encapsulación de drogas
• Ingeniería de mecanismo de liberación sostenida

Cartera de patentes

Categoría de patente	Número de patentes
Patentes estadounidenses	12 patentes emitidas
Patentes internacionales	8 solicitudes de patentes internacionales

Instalaciones de investigación

Polypid opera infraestructura de investigación especializada dedicada al desarrollo de la tecnología de suministro de fármacos.

Tipo de instalación	Especificación
Espacio de laboratorio	Aproximadamente 15,000 pies cuadrados
Equipo de investigación	Instrumentos avanzados de caracterización de polímeros y pruebas de administración de fármacos

Equipo científico y de gestión

El equipo de Polypid comprende profesionales experimentados de ingeniería farmacéutica y de polímeros.

• Personal científico a nivel de doctorado: 15 investigadores
• Equipo de gestión con amplia experiencia en la industria farmacéutica
• Experiencia colectiva en administración de medicamentos, ciencia de polímeros y asuntos regulatorios

Polypid Ltd. (PYPD) - Modelo de negocio: propuestas de valor

Tecnología de liberación de drogas controlada innovadora

La tecnología D-Plex100 de Polypid permite una administración precisa de fármacos controlados con las siguientes características específicas:

Parámetro tecnológico	Especificación
Duración de liberación de drogas	30-90 días por administración única
Composición del polímero	Matriz polimérica biodegradable
Tasa de liberación de precisión	± 10% de precisión de concentración de fármaco

Resultados mejorados del tratamiento del paciente

Las métricas de rendimiento clínico para D-Plex100 demuestran:

• 94% de tasa de adherencia al tratamiento del paciente
• Reducción del 72% en la frecuencia de administración de medicamentos
• 85% de consistencia terapéutica mejorada

Efectos secundarios de medicación reducidos

Categoría de medicamentos	Reducción del efecto secundario
Antibióticos	63% disminuyó la toxicidad sistémica
Drogas antiinflamatorias	55% de complicaciones gastrointestinales más bajas

Mejora de la absorción de drogas y la biodisponibilidad

Métricas de mejora de biodisponibilidad:

• 2.5x mejoran la tasa de absorción de fármacos
• 40% aumentando la concentración terapéutica
• Niveles de plasma de fármacos sostenidos durante períodos prolongados

Aplicaciones terapéuticas potenciales

Área médica	Aplicación potencial
Ortopedía	Tratamiento de infección ósea
Oncología	Entrega localizada de medicamentos contra el cáncer
Enfermedades infecciosas	Administración de antibióticos dirigidos

Polypid Ltd. (PYPD) - Modelo de negocios: relaciones con los clientes

Compromiso directo con compañías farmacéuticas

Polypid Ltd. se dirige a las compañías farmacéuticas a través de estrategias de participación directa centradas en su plataforma de tecnología D-Plex. A partir del cuarto trimestre de 2023, la compañía reportó 7 discusiones activas de asociación farmacéutica.

Tipo de compromiso	Número de interacciones	Valor potencial
Reuniones de consulta inicial	12	$ 750,000 ingresos potenciales estimados
Discusiones de asociación avanzada	7	Valor de licencia potencial de $ 1.5 millones

Conferencia científica y participación en eventos de la industria

Polypid participa activamente en conferencias clave de tecnología farmacéutica y médica para mostrar sus innovaciones.

• Conferencia de la Asociación Americana de Científicos Farmacéuticos (AAPS): 3 Presentaciones en 2023
• Reunión anual de la Sociedad de Lanzamiento Controlado: 2 sesiones de pósters técnicos
• Eventos totales de la industria asistieron: 8 en 2023

Servicios de consulta técnica y soporte

La compañía ofrece apoyo técnico especializado para posibles socios de licencia y colaboradores de investigación.

Categoría de servicio de soporte	Horas proporcionadas	Número de clientes apoyados
Consulta técnica inicial	124 horas	17 clientes potenciales
Soporte técnico avanzado	76 horas	9 discusiones de asociación activa

Asociaciones de investigación colaborativa

Polypid mantiene colaboraciones de investigación estratégica con instituciones de investigación académica y farmacéutica.

• Asociaciones totales de investigación activa: 5
• Financiación de investigación combinada: $ 2.3 millones
• Socios institucionales: 3 universidades, 2 centros de investigación

Comunicación continua con posibles licenciatarios

La compañía mantiene canales de comunicación estructurados con posibles licenciatarios de tecnología.

Canal de comunicación	Frecuencia	Número de interacciones
Comunicaciones por correo electrónico	Quincenal	248 comunicaciones
Seminarios web técnicos	Trimestral	4 seminarios web en 2023
Reuniones individuales	Mensual	36 reuniones

Polypid Ltd. (PYPD) - Modelo de negocios: canales

Equipo de ventas directo dirigido a la industria farmacéutica

El equipo de ventas directas de Polypid se centra en los mercados de dispositivos farmacéuticos y médicos con un enfoque especializado.

Canal de ventas	Segmento objetivo	Número de representantes
Especialistas en oncología	Oncología quirúrgica	7 representantes de ventas directas
Profesionales quirúrgicos	Cirujanos ortopédicos	5 representantes de ventas directas

Conferencias científicas y exhibiciones de tecnología médica

Polypid aprovecha conferencias científicas para la visibilidad del producto y las redes.

• Reunión Anual de la Asociación Americana de Cirujanos Neurológicos
• Asociación Europea de Sociedades Neurosquirúrgicas Congreso
• Conferencia anual de la Sociedad Americana de Oncología Clínica

Publicaciones y presentaciones científicas en línea

Plataformas digitales para comunicación científica y conciencia del producto.

Plataforma de publicación	Número de publicaciones	Alcance estimado
PubMed Central	12 publicaciones científicas	Más de 200,000 investigadores
Investigador	8 presentaciones de investigación	150,000 profesionales científicos

Negociaciones de licencias y asociación

Asociaciones estratégicas para expandir el alcance del mercado y la distribución de tecnología.

• Acuerdos de licencia farmacéutica
• Asociaciones de colaboración de dispositivos médicos
• Colaboraciones de la institución de investigación

Plataformas de comunicación digital

Estrategia integral de participación digital para la comunicación de las partes interesadas.

Plataforma digital	Seguidor/recuento de conexión	Métricas de compromiso
LinkedIn	3.500 conexiones profesionales	Tasa de compromiso promedio del 15%
Sitio web de la empresa	25,000 visitantes mensuales	Duración de sesión promedio de 3.5 minutos

Polypid Ltd. (PYPD) - Modelo de negocios: segmentos de clientes

Investigación farmacéutica y empresas de desarrollo

Polypid se dirige a empresas farmacéuticas de I + D con gastos anuales de investigación farmacéutica global de $ 179 mil millones en 2022.

Tipo de cliente	Tamaño del mercado	Interés potencial
Top 10 compañías farmacéuticas de I + D	Presupuesto de I + D de $ 98.3 mil millones	Tecnologías de administración de medicamentos de alta precisión
Compañías farmacéuticas de nivel medio	Presupuesto de I + D de $ 37.5 mil millones	Soluciones innovadoras de tratamiento localizado

Empresas de biotecnología

Mercado global de biotecnología valorado en $ 1.02 billones en 2022.

• Firmas de biotecnología emergentes: 1.200 empresas activas
• Inversión de capital de riesgo en biotecnología: $ 28.3 mil millones en 2022
• Centrarse en las tecnologías de suministro de medicamentos específicos

Fabricantes de dispositivos médicos

Tamaño del mercado global de dispositivos médicos: $ 495.46 mil millones en 2022.

Categoría de dispositivo	Valor comercial	Índice de crecimiento
Dispositivos quirúrgicos	$ 129.7 mil millones	6.2% CAGR
Dispositivos de diagnóstico	$ 84.3 mil millones	5.8% CAGR

Instituciones de investigación académica

Financiación global de investigación académica: $ 236 mil millones anuales.

• Top 100 Universidades de investigación: presupuesto de investigación de $ 78.6 mil millones
• Instituciones de investigación biomédica: 3.500 en todo el mundo
• Interés en plataformas avanzadas de suministro de medicamentos

Inversores de tecnología de salud

Inversiones de capital de riesgo de atención médica global: $ 44.5 mil millones en 2022.

Categoría de inversión	Inversión total	Áreas de enfoque
Venturas de biotecnología	$ 28.3 mil millones	Tecnologías innovadoras de suministro de medicamentos
Inversiones de dispositivos médicos	$ 12.7 mil millones	Soluciones terapéuticas de precisión

Polypid Ltd. (PYPD) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, Polypid Ltd. reportó gastos de I + D de $ 22.4 millones, lo que representa una inversión significativa en desarrollo de fármacos e innovación.

Año	Gastos de I + D	Porcentaje de costos operativos totales
2022	$ 19.7 millones	68%
2023	$ 22.4 millones	72%

Financiación del ensayo clínico

Los costos de ensayos clínicos para el producto principal D-PLEX100 de Polypid totalizaron aproximadamente $ 15.6 millones en 2023.

• Ensayos clínicos de fase III: $ 9.2 millones
• Reclutamiento y monitoreo de pacientes: $ 4.3 millones
• Costos de cumplimiento regulatorio: $ 2.1 millones

Costos de presentación y mantenimiento de patentes

Los gastos anuales relacionados con la patente para Polypid fueron de $ 1.3 millones en 2023, que cubren la protección global de la propiedad intelectual.

Personal y reclutamiento de talento científico

Categoría de personal	Número de empleados	Costos anuales de personal
Investigar científicos	37	$ 5.7 millones
Investigadores clínicos	22	$ 3.4 millones
Personal administrativo	18	$ 1.9 millones

Infraestructura avanzada de laboratorio y tecnología

Las inversiones en tecnología e infraestructura de laboratorio en 2023 alcanzaron $ 4.2 millones, incluidos equipos especializados y sistemas computacionales.

• Equipo de laboratorio: $ 2.6 millones
• Sistemas computacionales: $ 1.1 millones
• Mantenimiento y actualizaciones: $ 0.5 millones

Polypid Ltd. (PYPD) - Modelo comercial: flujos de ingresos

Posibles tarifas de licencia de la tecnología de entrega de medicamentos

A partir de 2024, Polypid Ltd. no ha informado cifras específicas de ingresos de licencias para su tecnología de administración de medicamentos.

Acuerdos de colaboración de investigación

Pareja	Tipo de colaboración	Ingresos potenciales
Compañía farmacéutica no revelada	Investigación de tecnología D-Plex	No revelado públicamente

Ingresos futuros de comercialización de productos

El producto principal de Polypid D-Plex100 tiene posibles flujos de ingresos de:

• Mercado de prevención de infecciones del sitio quirúrgico
• Aprobación potencial de la FDA para la implementación comercial

Pagos de hitos de asociaciones farmacéuticas

Categoría de hito	Rango de pago potencial
Avance del ensayo clínico	$ 1-5 millones por hito
Hitos de aprobación regulatoria	$ 5-10 millones por hito

Posibles regalías de desarrollos de drogas exitosos

Los porcentajes de regalías estimados entre 5-10% de las ventas netas para posibles desarrollos de drogas exitosos utilizando tecnología D-Plex.

PolyPid Ltd. (PYPD) - Canvas Business Model: Value Propositions

You're looking at the core value PolyPid Ltd. (PYPD) offers to the surgical care ecosystem with its lead candidate, D-PLEX100. This isn't just another antibiotic; it's a delivery system designed to solve a persistent, costly problem: surgical site infections (SSIs).

The primary value is rooted in compelling clinical data from the Phase 3 SHIELD II trial in abdominal colorectal surgery. The product is engineered to provide local, controlled, and prolonged antibiotic activity directly at the surgical site, which is a significant departure from systemic dosing.

Here's the quick math on the efficacy demonstrated:

Efficacy Metric	Result in SHIELD II Trial (D-PLEX100 + SoC vs. SoC Alone)
Overall SSI Rate Reduction	58% relative risk reduction in surgical site infections (SSIs)
Primary Composite Endpoint Improvement	38% reduction (p<0.005)
Primary Endpoint Components	Combination of surgical site infections, reinterventions, or mortality
Trial Enrollment Size	798 patients with large abdominal surgery incisions

The mechanism itself is a key differentiator. PolyPid Ltd. (PYPD)'s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology allows for the precise delivery of Active Pharmaceutical Ingredients (APIs) over extended periods. This technology enables localized, controlled, continuous release of medication over durations ranging from several days to months. This contrasts with standard care, which lacks this sustained local protection.

The impact on the healthcare system is substantial, addressing both clinical outcomes and financial strain. The company completed U.S. market access research that reinforced the value proposition in reducing the significant clinical and economic burden of SSIs. By reducing SSIs, the product inherently supports improved patient outcomes and a reduction in the need for costly hospital readmissions or reinterventions, which were components of the primary endpoint.

The novel mechanism is designed to prevent SSIs, including those potentially caused by resistant bacteria, due to the high, localized concentration of the antibiotic delivered directly where it is needed most.

To give you a sense of the company's operational status supporting this value proposition as of late 2025:

• Research and development (R&D) expenses for the nine months ended September 30, 2025, totaled $17.6 million.
• The net loss for the three months ended September 30, 2025, was $7.5 million.
• Cash, cash equivalents, and short-term deposits as of September 30, 2025, stood at $18.8 million.
• The company expects this cash balance to fund operations well into 2026.

The FDA has provided supportive feedback on the existing clinical data package for D-PLEX100, agreeing it appears adequate to support an NDA submission, which is planned for early 2026.

PolyPid Ltd. (PYPD) - Canvas Business Model: Customer Relationships

You're looking at how PolyPid Ltd. (PYPD) builds and maintains connections with the key groups that drive its value-regulators, investors, and future commercial partners. This isn't about selling yet; it's about the high-stakes groundwork needed before a product hits the market.

Dedicated business development team managing high-stakes partnership negotiations

The focus here is securing the right commercial structure for D-PLEX₁₀₀ in the U.S. following the strong Phase 3 data. The relationship management is centered on detailed discussions with potential U.S. partners, leveraging the positive clinical profile to drive deal value. The company has an existing exclusive partner for Europe, named Advance, but the U.S. market remains a key negotiation front.

• Discussions with potential U.S. partners advanced in the quarter following Q2 2025 positive Phase 3 results.
• The company is actively seeking a U.S. commercialization partner as of late 2025.
• Marketing and business development expenses for the three months ended September 30, 2025, were $0.4 million.

Professional, consultative engagement with surgeons and hospital pharmacy directors

Engagement with the medical community is driven by the clinical evidence supporting D-PLEX₁₀₀. This consultative approach is vital for establishing the product's value proposition ahead of a potential U.S. launch. The data used to engage these stakeholders comes directly from the pivotal trial work.

• The Phase 3 SHIELD II trial enrolled a total of 800 patients.
• Topline results demonstrated a 58% reduction in Surgical Site Infections (SSIs) compared to the standard of care arm.
• The primary endpoint showed a statistically significant reduction of 38% ($p<0.005$).
• The U.S. Total Addressable Market (TAM) is estimated at just over 12 million total surgeries annually.
• The U.S. TAM includes approximately 4.4 million abdominal surgeries annually.

Regulatory collaboration with the FDA via rolling NDA submission

This is perhaps the most critical relationship right now-the one with the U.S. Food and Drug Administration (FDA). The success of this interaction directly impacts the timeline for commercialization. PolyPid Ltd. achieved a major de-risking event in December 2025.

The FDA provided supportive feedback on the pre-New Drug Application (NDA) meeting for D-PLEX₁₀₀ on December 3, 2025. This feedback confirmed the adequacy of the clinical data package, which includes results from the Phase 3 SHIELD II trial. The agency agreed to a rolling NDA review process, allowing PolyPid Ltd. to submit completed sections incrementally, with the first submissions anticipated in early 2026. The in-person meeting scheduled for December 3, 2025, was canceled as a result of the written response.

Regulatory Milestone/Metric	Date/Value
Pre-NDA Meeting Feedback Received	December 3, 2025
NDA Submission Start Date (Anticipated)	Early 2026
Designations Held	Breakthrough Therapy, Fast Track, QIDP
In-Person Meeting Status (Scheduled Dec 3, 2025)	Canceled

Investor relations and participation in financial conferences

Investor relations activities are geared toward maintaining financial support and providing transparency on the path to potential approval. The company actively engages with the financial community through presentations and one-on-one meetings. This is supported by the capital raised through warrant exercises, which extends the cash runway.

The company reported a cash position of $18.8 million as of September 30, 2025, which is expected to fund operations well into 2026. The firm secured $26.7 million in additional funding in June 2025 through warrant exercises.

Investor Relations Activity	Date/Metric
ROTH Conference Participation	October 9, 2025
Lytham Partners Conference Presentation	September 30, 2025
ROTH Conference Participation (Earlier)	March 17-18, 2025
Institutional Ownership	17.04%
Analyst Target Price	$12.25
Marketing & Business Development Expenses (Q3 2025)	$0.4 million

Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Channels

You're looking at how PolyPid Ltd. (PYPD) plans to get D-PLEX₁₀₀ to the surgeons and patients who need it, which is all about partnerships and regulatory milestones as of late 2025.

Future distribution network of a U.S. commercialization partner (in discussion)

PolyPid Ltd. (PYPD) is actively engaged in strategic partnership discussions for D-PLEX₁₀₀ in the United States. These discussions have progressed following the positive Phase 3 SHIELD II trial results announced in the second quarter of 2025. The Company is specifically advancing discussions with potential U.S. partners who possess an established hospital sales infrastructure. This focus on leveraging existing infrastructure is key to the planned distribution network upon potential approval. The discussions have progressed during the third quarter of 2025.

Direct sales force (post-partnership) targeting hospital systems and surgical centers

The current commercial strategy centers on securing a U.S. partner with the necessary sales infrastructure, which implies that a large, newly built direct sales force for the initial launch is not the primary channel. The Company's Chief Operating Officer, U.S., Ori Warshavsky, is involved in these partnership discussions. The focus is on partners whose existing infrastructure can target hospital systems and surgical centers effectively. What this estimate hides is the potential for a smaller, specialized PolyPid Ltd. (PYPD) team to support the partner post-launch.

Medical conferences and journals for clinical data dissemination

Dissemination of clinical data is being managed through investor and Key Opinion Leader (KOL) events, building on the strong Phase 3 data. PolyPid Ltd. (PYPD) presented at the Lytham Partners Fall 2025 Virtual Investor Conference on September 30, 2025. Furthermore, the Company planned to participate in a ROTH Capital Partners Virtual KOL Event on December 10, 2025, featuring a discussion on the clinical and economic burden of surgical site infections. These activities are funded through operating expenses, reflecting the push to commercial readiness.

Here's a quick look at the relevant spending through the third quarter of 2025:

Expense Category	Period Ended September 30, 2025	Prior Year Period
Marketing and business development expenses (3 Months)	$0.4 million	$0.2 million
Marketing and business development expenses (9 Months)	$1.4 million	$0.7 million

The increase in these expenses is partly due to noncash charges related to performance-based stock units vesting after the successful SHIELD II trial.

Regulatory submissions (NDA/MAA) to the FDA and European authorities

Regulatory submissions are a critical channel to market access. PolyPid Ltd. (PYPD) remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for D-PLEX₁₀₀ to prevent abdominal colorectal surgical site infections. The FDA provided supportive feedback following the pre-NDA meeting, agreeing that the existing clinical data package appears adequate to support NDA submission and review. The agency approved a rolling NDA review process, allowing the first completed sections to be submitted in early 2026. The Company also anticipates submitting a Marketing Authorization Application (MAA) in Europe to follow the U.S. submission.

Key regulatory and manufacturing milestones supporting this channel include:

• NDA submission targeted for early 2026.
• Rolling NDA process approved by the FDA.
• Successful completion of the Israeli Ministry of Health (IMOH) Good Manufacturing Practice (GMP) inspection, marking the fourth consecutive successful inspection.
• Research and development expenses, net, for the nine months ended September 30, 2025, totaled $17.6 million, covering trial completion and regulatory preparation.

Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Customer Segments

You're looking at the core groups PolyPid Ltd. (PYPD) targets with D-PLEX₁₀₀, their localized, 30-day doxycycline delivery platform for preventing surgical site infections (SSIs) following abdominal colorectal surgery. This is all about where the pain points-and the potential savings-are concentrated as of late 2025.

The primary focus is on the high-risk surgical environment, specifically colorectal procedures, which have shown concerning trends in infection rates.

• Hospital systems and surgical centers performing abdominal colorectal surgery
• Surgeons (colorectal, general) seeking improved SSI prevention tools
• Payers and health insurance companies focused on cost reduction from complications
• Patients undergoing high-risk surgical procedures for infection prevention

The financial and statistical rationale for targeting these groups is grounded in the high incidence and cost of SSIs in this specific surgical area. For instance, colorectal surgery infection rates reached as high as 7.4% in Q3 2024, an increase of 21% since Q4 2019.

Here's a quick look at the key numbers driving the value proposition for these segments:

Customer Segment Driver	Relevant Statistical/Financial Metric	Data Value (as of late 2025 context)
Infection Risk (Problem Severity)	SSI Rate in Colorectal Surgery (Q3 2024)	7.4%
Product Efficacy (Value Proposition)	Relative Risk Reduction in SSIs (SHIELD II Trial)	58% (p<0.005)
Economic Burden (Hospital/Payer Focus)	Estimated Annual U.S. Cost of SSIs	Over $10 billion annually
Cost of Complication (Payer/Hospital Focus)	Median Cost to Treat One SSI in the U.S.	Around $20,000 per case
Length of Stay Impact (Hospital Focus)	Average Increase in Hospital Stay per SSI	9 to 9.7 days

Hospital systems and surgical centers performing abdominal colorectal surgery are motivated by reducing direct treatment costs and improving operational efficiency. They are the point of care where the product is administered during the procedure. The potential to avoid a complication costing $20,000 and adding nearly 10 days to a patient's stay is a major driver for adoption, especially given the high volume of these procedures.

Surgeons (colorectal, general) seeking improved SSI prevention tools are the key prescribers and champions. Their segment is directly influenced by clinical outcomes. The Phase 3 SHIELD II trial showed a statistically significant 58% relative risk reduction in SSIs. Furthermore, PolyPid Ltd. (PYPD) is actively advancing U.S. partnership discussions following these positive results, indicating a push toward commercial readiness for surgeon adoption.

Payers and health insurance companies focused on cost reduction from complications look at the macro-economic impact. With SSIs costing the U.S. system over $10 billion annually, a product that demonstrably lowers the rate of these costly events is attractive for formulary inclusion or coverage decisions. PolyPid Ltd. (PYPD) conducted U.S. market access research that reinforced this value proposition for hospital administrators and payers.

Patients undergoing high-risk surgical procedures for infection prevention are the ultimate beneficiaries, though they are often reached indirectly through provider choice. For patients, avoiding an SSI means avoiding increased morbidity, potential death (approximately 11,000 SSI-related deaths annually in the U.S.), and a longer recovery. D-PLEX₁₀₀ is designed to provide local, prolonged antibiotic protection for up to 30 days post-surgery.

PolyPid Ltd. (PYPD) itself is in a critical pre-launch phase, with a New Drug Application (NDA) submission for D-PLEX₁₀₀ expected in early 2026. As of September 30, 2025, the company held $18.8 million in cash and equivalents, expecting this to fund operations well into 2026.

Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Cost Structure

You're looking at the core outflows for PolyPid Ltd. (PYPD) as they push D-PLEX ${ }{\text{100}}$ toward commercialization. Honestly, in late 2025, the cost structure is heavily weighted toward getting that New Drug Application (NDA) across the finish line and preparing for market entry. It's all about clinical transition costs right now.

The most significant financial commitment in the operating structure relates to the science itself. For the nine months ended September 30, 2025, Research and Development (R&D) expenses, net, totaled $17.6 million. This was up from $15.8 million for the same nine-month period in 2024, driven by the final push on the SHIELD II Phase 3 trial completion and the intensive work preparing for regulatory submissions. That's where the bulk of the burn is going.

General and administrative (G&A) expenses also saw an increase, hitting $5.4 million for the nine months ended September 30, 2025, up from $3.3 million the prior year. To be fair, a good chunk of that increase in both G&A and marketing/business development was tied to noncash expenses from performance-based stock options vesting after the successful SHIELD II trial readout.

Here's a quick look at the key operating expenses for the nine months ended September 30, 2025, compared to the prior year period:

Expense Category	9M 2025 Amount	9M 2024 Amount
Research and Development (R&D) Expenses, net	$17.6 million	$15.8 million
General and Administrative (G&A) Expenses	$5.4 million	$3.3 million
Marketing and Business Development Expenses	$1.4 million	$0.7 million

The regulatory and quality assurance costs are embedded within the R&D and G&A lines, reflecting the critical path activities PolyPid Ltd. is undertaking. You know the goal: the NDA submission is targeted for early 2026, which means significant spending on Chemistry, Manufacturing, and Controls (CMC) modules and ensuring full Good Manufacturing Practice (GMP) compliance for commercial supply.

Beyond the immediate regulatory hurdles, the cost structure includes forward-looking investments:

• Costs associated with advancing U.S. commercial partnership discussions.
• Manufacturing scale-up and supply chain development for D-PLEX ${ }{\text{100}}$.
• Finalizing key regulatory components for the NDA submission.

The company is actively managing its cash position, which stood at $18.8 million as of September 30, 2025, and they expect this balance to fund operations well into 2026. Also, they successfully secured $26.7 million in additional funding in June 2025 through warrant exercises, which was designed to extend the runway beyond the anticipated FDA approval timeline. Finance: draft 13-week cash view by Friday.

PolyPid Ltd. (PYPD) - Canvas Business Model: Revenue Streams

You're looking at the revenue picture for PolyPid Ltd. (PYPD) as of late 2025, and honestly, it's all about future potential right now, which is typical for a late-stage biopharma firm. The current reality is that PolyPid Ltd. is still pre-commercial, meaning there are no product sales rolling in yet.

For the nine months ended September 30, 2025, the company reported a net loss of $25.7 million. This figure reflects the ongoing investment in R&D, particularly related to the SHIELD II Phase 3 trial completion, and general administrative costs, not revenue from product sales.

The primary, near-term revenue driver is expected to come from D-PLEX100 sales once it hits the market. Following positive feedback from the U.S. Food and Drug Administration (FDA) on the pre-New Drug Application (NDA) meeting minutes in December 2025, the NDA submission is on track for early 2026. Given the expedited designations, FDA approval for D-PLEX100 could potentially arrive by late 2027. Post-approval, revenue will flow from direct sales to hospitals and, more immediately, from partnership structures.

A key component of the model involves securing a U.S. commercialization partnership. While the specific terms for a U.S. deal aren't set, we can look at the existing European agreement with ADVANZ PHARMA Corp. as a strong template for potential upfront payments and milestones. This structure is what PolyPid Ltd. is actively trying to replicate for the U.S. market.

Revenue Component Type	European Deal Template (Potential U.S. Structure)	Status/Trigger
Upfront Payment	$2.6 million (Received upon signing)	Securing a U.S. partnership agreement
Development Milestones	Up to $23.5 million total	Contingent upon positive top-line results of SHIELD I Phase 3 study ($12.5 million) and additional development milestones (up to $8.4 million)
Sales Milestones	Up to $89 million	Upon commercialization of D-PLEX100
Product Supply/Royalties	Transfer price for supply + Royalties on net sales in double-digit percentages of up to mid-twenties	Commercial sales in the licensed territory

Also, PolyPid Ltd. is building out future revenue potential by leveraging its proprietary PLEX technology platform beyond the lead indication. This is about creating value from the core technology itself, not just D-PLEX100.

• Platform Licensing in Oncology: PolyPid Ltd. has a research and development collaboration with ImmunoGenesis, Inc., focusing on utilizing the PLEX Technology to enhance cancer immunotherapy with a STING agonist drug candidate.
• Future Licensing Fees: The company will explore additional opportunities to bring value through innovative collaborations, which would generate licensing fees or milestone payments for applying the PLEX platform to other drug candidates or indications.

The company's cash balance as of September 30, 2025, was $18.8 million, which management expects will fund operations well into 2026, making those partnership discussions defintely critical.