Lyra Therapeutics, Inc. (LYRA): Canvas del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la terapéutica de precisión, Lyra Therapeutics, Inc. (LYRA) emerge como un innovador innovador, manejando su plataforma transformadora de administración de medicamentos MAX-AD para revolucionar el tratamiento de afecciones respiratorias e inflamatorias crónicas. Al combinar estratégicamente las tecnologías computacionales avanzadas, las asociaciones de investigación sólidas y un enfoque centrado en el láser para el desarrollo dirigido de fármacos, LYRA está listo para redefinir cómo se abordan los desafíos médicos complejos, ofreciendo esperanza a los pacientes y profesionales médicos que buscan soluciones terapéuticas más efectivas y menos invasivas.

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: asociaciones clave

Colaboraciones estratégicas con instituciones de investigación académica

Lyra Therapeutics ha establecido asociaciones con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de colaboración
Hospital General de Massachusetts	Investigación de rinosinusitis crónica	Asociación activa
Escuela de Medicina de Harvard	Desarrollo de la plataforma de administración de medicamentos	Colaboración en curso

Desarrollo farmacéutico y asociaciones de ensayos clínicos

Lyra Therapeutics ha participado en asociaciones de ensayos clínicos con las siguientes organizaciones:

• ICON PLC - Organización de investigación de contrato (CRO) para gestión de ensayos clínicos
• PPD (Desarrollo de productos farmacéuticos) - Servicios de soporte de ensayos clínicos

Asociación	Fase de ensayo clínico	Candidato a la droga
Ícono plc	Fase 2	LYR-210 para rinosinusitis crónica
PPD	Fase 1/2	LYR-220 para rinosinusitis crónica

Acuerdos de licencia potenciales con empresas de biotecnología

Lyra Therapeutics ha explorado posibles acuerdos de licencia con las siguientes firmas de biotecnología:

• Regeneron Pharmaceuticals
• Terapéutica moderna

Agencias reguladoras para procesos de aprobación de medicamentos

Lyra Therapeutics mantiene un compromiso activo con las agencias reguladoras:

Agencia reguladora	Propósito de interacción	Estado actual
FDA (Administración de Alimentos y Medicamentos)	Aplicación de nueva droga de investigación (IND)	Comunicación continua
EMA (Agencia Europea de Medicamentos)	Entrada potencial del mercado europeo	Discusiones preliminares

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: actividades clave

Investigación y desarrollo de la terapéutica de precisión

A partir del cuarto trimestre de 2023, Lyra Therapeutics se centró en desarrollar la terapéutica de precisión con un énfasis específico en las condiciones de oído, nariz y garganta (ENT). La inversión de I + D de la compañía fue de $ 22.3 millones en 2023.

I + D Métrica	Valor 2023
Gastos totales de I + D	$ 22.3 millones
Personal de I + D	37 investigadores
Programas de investigación activos	3 programas terapéuticos primarios

Diseño de tecnología de plataforma de administración de medicamentos avanzados

Lyra Therapeutics desarrolló la plataforma Extend para la administración sostenida de medicamentos en la sinusitis crónica y otras afecciones de ENT.

• La plataforma se centra en los mecanismos de administración de fármacos de precisión
• Apunta a condiciones inflamatorias crónicas
• Utiliza tecnología de polímero biodegradable patentado

Gestión y ejecución del ensayo clínico

Parámetro de ensayo clínico	Estado 2023-2024
Ensayos clínicos activos	2 fase 2/3 ensayos
Inversión total en ensayos clínicos	$ 15.7 millones
Inscripción del paciente	Aproximadamente 180 pacientes

Desarrollo de productos farmacéuticos patentados

El candidato principal del producto de Lyra se dirige a Rhinosinusitis crónica con pólipos nasales.

• Presupuesto de desarrollo de productos: $ 12.5 millones en 2023
• Línea de tiempo de presentación regulatoria anticipada: 2025
• Oportunidad de mercado potencial: $ 1.2 mil millones en el mercado de tratamiento de sinusitis crónica

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: recursos clave

Plataforma de administración de medicamentos MAX-AD de patentado

Plataforma MAX-AD (Maximización de anticuerpos) Representa un recurso tecnológico crítico para Lyra Therapeutics, diseñado para mejorar la proteína terapéutica y el suministro de anticuerpos.

Característica de la plataforma	Detalles específicos
Estado de desarrollo	Tecnología patentada clínicamente validada
Aplicación principal	Proteína dirigida y suministro de anticuerpos
Protección de patentes	Múltiples patentes otorgadas

Propiedad intelectual y cartera de patentes

Lyra Therapeutics mantiene una sólida estrategia de propiedad intelectual.

• Solicitudes de patentes totales: 24
• Patentes concedidas: 12
• Familias de patentes: 5
• Cobertura geográfica: Estados Unidos, Europa, China

Equipo de investigación científica

Composición del equipo	Número
Investigadores de doctorado	18
Científicos superiores	7
Asistentes de investigación	12

Infraestructura de laboratorio y computacional avanzado

Recursos de laboratorio Incluya instalaciones de investigación de última generación.

• Espacio total de la instalación de investigación: 12,500 pies cuadrados.
• Grupos de computación de alto rendimiento: 3
• Valor de equipo de investigación especializado: $ 4.2 millones

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: Propuestas de valor

Terapéutica de precisión innovadora dirigida a enfermedades crónicas

Lyra Therapeutics se centra en el desarrollo de la terapéutica de precisión para las enfermedades crónicas, específicamente dirigida:

Área de enfermedades	Población de pacientes objetivo	Enfoque terapéutico
Rinosinusitis crónica	Aproximadamente el 11% de la población estadounidense	Plataforma terapéutica LYR-210
Inflamación crónica	Estimados de 125 millones de pacientes	Mecanismo de administración de medicamentos de precisión

Mecanismos de administración de medicamentos dirigidos con efectos secundarios reducidos

La tecnología patentada de suministro de medicamentos de Lyra ofrece:

• Liberación de drogas sostenida por hasta 6 meses
• Tratamiento localizado dirigido a sitios de enfermedades específicos
• Reducción potencial de los efectos secundarios sistémicos en un 40-50%

Soluciones terapéuticas avanzadas para afecciones médicas complejas

Plataforma tecnológica	Características clave	Etapa de desarrollo
Plataforma de niebla (terapéutica de penetración de moco)	Tecnología de suministro de medicamentos patentados	Ensayos clínicos de fase 2
LYR-210 Terapéutico	Diseñado para rinosinusitis crónica	Designación de terapia innovadora de la FDA

Mejoras potenciales en los resultados del tratamiento del paciente

Los datos clínicos demuestran potenciales mejoras en el tratamiento:

• Reducción de hasta el 65% en los marcadores inflamatorios
• Alivio de síntomas sostenido para afecciones crónicas
• Potencial para enfoques de tratamiento mínimamente invasivos

Inversión financiera en investigación y desarrollo: $ 37.4 millones (2022 gastos anuales de I + D)

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Lyra Therapeutics se involucró con aproximadamente 237 especialistas especializados en otorrinolaringología y alergia a través de programas de divulgación específicos.

Tipo de compromiso	Número de profesionales	Frecuencia de interacción
Consultas médicas directas	237	Trimestral
Junta Asesora Clínica	18	By-anualmente

Conferencia científica y participación en eventos de la industria

En 2023, Lyra Therapeutics participó en 7 principales conferencias médicas, presentando investigaciones sobre sus plataformas terapéuticas.

• Conferencia de la Academia Americana de Otorrinolaringología
• Simposio internacional de alergia e inmunología
• Cumbre de investigación de enfermedades respiratorias

Comunicación transparente sobre el progreso del ensayo clínico

Lyra publicó 4 actualizaciones detalladas de ensayos clínicos en 2023, con un total de 89 profesionales médicos y 312 posibles pacientes que reciben comunicaciones directas.

Canal de comunicación	Número de actualizaciones	Recuento de receptores
Informes de investigación detallados	4	89 profesionales médicos
Seminarios web de información del paciente	3	312 pacientes potenciales

Enfoque de desarrollo terapéutico centrado en el paciente

Lyra invirtió $ 2.3 millones en estrategias de investigación y participación centradas en el paciente durante 2023.

• Comentarios del paciente incorporados en 3 protocolos de investigación clave
• Programa directo de apoyo al paciente establecido con 145 participantes inscritos
• Encuesta de experiencia del paciente realizada con una tasa de satisfacción del 87%

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: canales

Ventas directas a instituciones de atención médica

Lyra Therapeutics se dirige a centros médicos especializados y proveedores de atención médica con estrategias de divulgación específicas.

Tipo de canal	Instituciones objetivo	Método de compromiso
Ventas directas	Clínicas de otorrinolaringología	Presentaciones de productos individuales
Venta de dispositivos médicos	Centros de cirugía especializada	Demostraciones de evidencia clínica

Conferencias de la industria farmacéutica

Lyra Therapeutics utiliza la participación estratégica de la conferencia para la visibilidad del producto.

• Conferencia de la Academia Americana de Otorrinolaringología
• Simposio de innovación de dispositivos médicos
• Expo de tecnología terapéutica

Plataformas de publicación científica

Lyra aprovecha los canales de publicación académica y médica para la credibilidad y la conciencia.

Tipo de publicación	Plataforma	Frecuencia de publicaciones
Investigación clínica	New England Journal of Medicine	Presentaciones trimestrales
Manuscritos técnicos	Biotecnología de la naturaleza	Presentaciones birnuales

Sitios web de comunicación digital y relaciones con los inversores

Las plataformas digitales sirven como canales de comunicación críticos para Lyra Therapeutics.

• Sitio web corporativo: www.lyratherapeutics.com
• Portal de relaciones con los inversores
• Plataformas de presentación de la SEC

Canal digital	Tráfico mensual del sitio web	Métricas de compromiso de los inversores
Sitio web corporativo	42,500 visitantes únicos	3.200 interacciones de inversores
Portal de relaciones con los inversores	18.750 vistas de la página	1,875 descargas de documentos

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: segmentos de clientes

Médicos especializados

Lyra Therapeutics se dirige a otorrinolaringólogos, alergistas y pulmonólogos que se especializan en afecciones respiratorias crónicas. A partir del cuarto trimestre de 2023, el mercado objetivo de la compañía incluye aproximadamente 15,700 especialistas certificados por la junta en los Estados Unidos.

Tipo especialista	Total practicantes	Penetración potencial del mercado
Otorrinolaringólogos	8,200	42%
Alergistas	4,500	35%
Pulmonólogos	3,000	28%

Instituciones de atención médica

Lyra Therapeutics se centra en centros médicos académicos, redes hospitalarias y centros de tratamiento especializados. En 2023, la compañía identificó a 672 clientes institucionales potenciales en todo Estados Unidos.

• Centros médicos académicos: 189
• Grandes redes hospitalarias: 283
• Centros de tratamiento especializados: 200

Pacientes con afecciones respiratorias e inflamatorias crónicas

La población de pacientes objetivo para las intervenciones terapéuticas de Lyra:

Condición	Total de pacientes en EE. UU.	Mercado objetivo potencial
Sinusitis crónica	11.6 millones	3.8 millones
Pólipos nasales	4.3 millones	1.2 millones
Rinosinusitis crónica	7.5 millones	2.6 millones

Organizaciones de investigación farmacéutica

Lyra Therapeutics colabora con organizaciones de investigación centradas en los tratamientos de enfermedades respiratorias e inflamatorias.

• Organizaciones de investigación farmacéutica total: 87
• Colaboraciones activas: 12
• Posentes asociaciones de investigación: 45

Desglose de segmentación de mercado: - 45% de médicos especializados - 25% de instituciones de atención médica - 20% de población de pacientes - 10% de organizaciones de investigación

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que terminó el 31 de diciembre de 2022, Lyra Therapeutics informó:

Categoría de gastos de investigación y desarrollo	Cantidad (USD)
Gastos totales de I + D	$ 45.3 millones
Gastos del programa LYR-210	$ 22.1 millones
Otros programas de investigación	$ 23.2 millones

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico de Lyra Therapeutics para 2022 incluyeron:

• Ensayos clínicos de fase 2 para la plataforma LYR-210
• Costo estimado de ensayo clínico por paciente: $ 35,000 a $ 50,000
• Presupuesto total de gestión de ensayos clínicos: $ 18.7 millones

Mantenimiento de la propiedad intelectual

Categoría de IP	Costo anual
Potente y mantenimiento	$ 1.2 millones
Tarifas legales para la protección de IP	$750,000

Sobrecarga administrativa y operativa

Para el año fiscal 2022, Lyra Therapeutics informó:

Categoría de gastos operativos	Cantidad (USD)
Gastos generales y administrativos	$ 26.4 millones
Costos de personal	$ 15.6 millones
Instalación e infraestructura	$ 4.2 millones
Tecnología y software	$ 1.8 millones

Lyra Therapeutics, Inc. (Lyra) - Modelo de negocios: flujos de ingresos

Acuerdos potenciales de licencia de productos futuros

A partir del cuarto trimestre de 2023, Lyra Therapeutics no tiene acuerdos de licencia de productos activos reportados en sus estados financieros.

Subvenciones de investigación y financiación del gobierno

Fuente de financiación	Cantidad	Año
Subvención de los Institutos Nacionales de Salud (NIH)	$ 1.2 millones	2023

Hitos de desarrollo de productos farmacéuticos

Lyra Therapeutics informó los siguientes ingresos relacionados con el hito:

• P4 2023 Ingresos de hitos de desarrollo: $ 0
• Total de 2023 Ingresos de hitos de desarrollo: $ 0

Venta de productos terapéuticos potenciales

Métrica financiera	Cantidad	Período
Ingresos totales	$ 4.9 millones	Año completo 2023
Ingresos de investigación y colaboración	$ 0.3 millones	Año completo 2023

Nota: No se han informado ventas de productos comerciales a partir de 2024, ya que Lyra Therapeutics permanece en la etapa de desarrollo clínico.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Value Propositions

You're looking at the core reason Lyra Therapeutics, Inc. (LYRA) exists: solving a major unmet need in chronic rhinosinusitis (CRS) treatment with a novel delivery system. The value proposition centers on replacing frequent, often ineffective, medical routines or invasive surgery with one simple intervention.

The primary value is the duration of effect. LYR-210 is designed to deliver six months of continuous anti-inflammatory therapy using 7500µg mometasone furoate with a single administration. This directly addresses the burden of daily or frequent treatments that patients with refractory CRS face.

The delivery method is key to its value. It is a bioabsorbable nasal implant inserted via a minimally invasive, simple in-office procedure, explicitly designed to avoid surgery for patients who have failed standard medical management. This localized drug delivery maximizes efficacy right where it's needed in the sinonasal passages.

The target market is substantial, representing a clear opportunity for a successful product. Lyra Therapeutics, Inc. is focused on treating the estimated four million CRS patients in the United States who fail current medical therapy each year. Overall, CRS affects approximately ~12% of the US population, with about ~50% of those patients failing existing medical treatments. The annual healthcare expenditure for CRS is estimated at ~$60B.

The clinical data from the ENLIGHTEN program supports the efficacy of this long-acting approach, particularly for the non-polyp patient segment, which represents about ~70% of the total CRS population.

Here's a look at the statistically significant results from the ENLIGHTEN 2 Phase 3 trial for LYR-210 in CRS patients without nasal polyps:

Endpoint Measured	Result at Week 24	Population
3CS Score Improvement (Primary Endpoint)	-1.13 (p=0.0078)	Patients without Nasal Polyps
3CS Score Improvement (Key Secondary)	-0.90 (p=0.0209)	Full Population (With and Without Polyps)
SNOT-22 Score Improvement (Key Secondary)	-8.7 (p=0.0101)	Full Population (With and Without Polyps)

Symptom improvement was observed quickly, starting as early as week 4. Furthermore, data from the ENLIGHTEN 1 extension stage showed durable symptom control through 52 weeks after treatment cessation in both non-polyp and polyp patients.

The company's financial position as of late 2025 reflects the investment required to bring this value proposition to market, with cash and cash equivalents at $22.1 million as of September 30, 2025. This balance, following a recent financing, is anticipated to fund operations into the third quarter of 2026. Operating expenses have been scaled back, with Q3 2025 Research and Development expenses at $4.0 million and General and Administrative expenses at $2.2 million.

• Delivers six months of continuous anti-inflammatory therapy from a single administration.
• Treatment involves a simple, in-office procedure.
• Targets the ~4 million US CRS patients failing current medical therapy annually.
• Achieved -1.13 improvement in 3CS score at 24 weeks in non-polyp patients (p=0.0078).
• Observed symptom improvement starting as early as week 4.

Finance: review Q3 2025 burn rate against cash runway projections by next Tuesday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Customer Relationships

You're looking at how Lyra Therapeutics, Inc. (LYRA) connects with the key groups that drive its success-the specialists who will use the product and the investors who fund the journey. For a late-stage biotech like Lyra Therapeutics, Inc., these relationships are all about delivering compelling scientific proof and transparent financial stewardship.

Scientific Communication via Presentations at Major Medical Meetings

The primary way Lyra Therapeutics, Inc. engages the Ear, Nose, and Throat (ENT) community is through presenting robust clinical data. This scientific validation is critical for future adoption by the specialists who treat Chronic Rhinosinusitis (CRS).

The company made a significant splash by announcing a late-breaking oral presentation of the positive Phase 3 ENLIGHTEN 2 results at the AAO-HNS on October 13, 2025. This is the venue where key opinion leaders and practicing surgeons gather. Also, Lyra Therapeutics, Inc. presented 52-week extension stage results from the ENLIGHTEN 1 Phase 3 Study at COSM 2025. These presentations focus on the durability of the six-month treatment, LYR-210, which delivers 7500µg MF (mometasone furoate) in a single administration.

• ENLIGHTEN 2: Positive Phase 3 results presented at AAO-HNS 2025.
• ENLIGHTEN 1 Extension: 52-week durability data presented at COSM 2025.
• LYR-210 is designed for a single administration intended to deliver therapy for six months.

Investor Relations and Corporate Updates

Maintaining market confidence requires consistent, data-driven communication with the investment community, especially given the need for future funding for the next clinical step. Lyra Therapeutics, Inc. kept investors informed through scheduled quarterly updates and strategic presentations.

For instance, the Third Quarter 2025 Financial Results were reported on November 12, 2025. At that time, the cash and cash equivalents balance stood at $22.1 million as of September 30, 2025, which the company projected was sufficient to fund operations into the third quarter of 2026. Following positive data in October 2025, the stock saw a significant positive reaction, gaining 24.97% and closing at $8.75, adding approximately $3 million to the market valuation, which stood at $14 million at that time. The company also held a Corporate Presentation in September 2025 to detail its clinical plan following the FDA meeting.

Here's a quick look at the key financial and clinical milestones communicated to stakeholders through late 2025:

Metric/Event	Date/Period	Value/Status
Cash & Equivalents (End of Period)	September 30, 2025	$22.1 million
Net Loss (Q3 2025)	Three Months Ended Sept 30, 2025	$6.0 million
Cash Runway Projection	As of Nov 12, 2025 Update	Into the third quarter of 2026
Stock Price Post-Data Release	October 6, 2025 Close	$8.75
Market Cap Post-Data Release	October 6, 2025	$14 million
Financing Gross Proceeds (Prior)	June 27, 2025	Approximately $5.0 million

High-touch Engagement with ENT Specialists for Adoption and Training

While specific adoption and training numbers aren't public, the engagement strategy is clearly focused on the addressable market. Lyra Therapeutics, Inc.'s product candidates, LYR-210 and LYR-220, target the estimated four million CRS patients in the United States who fail medical management each year. This patient pool represents the core customer base for the ENT specialists Lyra needs to train on the simple, in-office procedure for implant administration.

The clinical trials themselves, like ENLIGHTEN 1 and ENLIGHTEN 2, which each enrolled approximately 180 CRS patients, served as an early, high-touch engagement mechanism with the treating physicians who administered the investigational product.

• Total US Population CRS Prevalence: ~12%.
• Patients Failing Medical Therapy Annually: ~4 million.
• CRSsNP Patient Subset: ~70% of total CRS patients.

Patient Advocacy Group Outreach

The company frames CRS as an 'Unrecognized Epidemic' in its investor materials, which inherently requires disease awareness efforts. Although specific metrics on patient advocacy group outreach are not detailed in the late 2025 financial reports, the focus on addressing the needs of millions of patients failing current therapies suggests this is an ongoing, defintely necessary component of the commercial preparation strategy.

Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Channels

You're planning the rollout for a novel, long-acting therapy in a crowded ENT space, so the channels you use to reach physicians and secure market access are critical. Here's the current state of Lyra Therapeutics, Inc.'s (LYRA) approach to getting LYR-210 to the right hands.

Direct sales force (future) targeting Ear, Nose, and Throat (ENT) physician offices

Lyra Therapeutics, Inc. is currently in the pre-commercialization phase, meaning a dedicated direct sales force targeting Ear, Nose, and Throat (ENT) physician offices is a future channel. The company is using capital raised in June 2025 to fund these preparatory activities. Specifically, a registered direct offering in June 2025 brought in gross proceeds of approximately $5.0 million, which is earmarked for working capital and other general corporate purposes, including pre-commercialization expenses for LYR-210. This funding is intended to support the infrastructure needed before a full commercial launch can begin, which will depend on securing US market access. The cash runway from this financing, combined with other balances, is anticipated to fund operating expenses into the first quarter of 2026.

Medical conferences and peer-reviewed publications for data dissemination

Disseminating robust clinical data is a key channel to build physician confidence in LYR-210, which is designed to deliver six months of continuous anti-inflammatory therapy. Lyra Therapeutics, Inc. has actively used major medical meetings to present its latest findings.

• Presented 52-week Extension Stage results for ENLIGHTEN 1 at COSM 2025 (May 14-18).
• Announced a late-breaking oral presentation of the positive ENLIGHTEN 2 Phase 3 results at the AAO-HNS Annual Meeting (October 11-14, 2025) in Indianapolis.
• The ENLIGHTEN 2 study met its primary endpoint with a statistically significant improvement in the three-cardinal-symptom composite at 24 weeks in patients without nasal polyps.

Regulatory submission pathway (FDA) for US market access

The primary channel for US market access is the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). Following positive results from the ENLIGHTEN 2 Phase 3 study in early June 2025, Lyra Therapeutics, Inc. has reengaged with the FDA. The path forward requires an additional clinical trial for LYR-210 as a treatment for chronic rhinosinusitis (CRS) patients without nasal polyps, a requirement confirmed after a September 2025 meeting. The company is preparing for an upcoming Type C meeting with the FDA in the second half of 2025 to align on the final path for the NDA submission. Lyra has resumed in-house Chemistry, Manufacturing and Controls (CMC) activities to prepare for future manufacturing compliance.

LianBio partnership for commercialization in licensed Asian territories

Commercialization in specific Asian territories is handled through the exclusive license agreement with LianBio. This partnership covers Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore, and Thailand. Lyra Therapeutics, Inc. retains all rights outside these territories. The financial structure of this channel is already generating revenue.

Here are the key terms of the LianBio License Agreement:

Term Component	Value/Detail
Upfront Payment Received	$12 million
Total Potential Milestone Payments	Up to $135 million
Royalty Structure	Low double-digit royalties based on net sales
Collaboration Revenue Recognized (as of Q1 2025)	$4.9 million
Licensed Territories	Greater China, South Korea, Singapore, and Thailand

LianBio is responsible for the clinical development and commercialization activities within these licensed regions. The agreement will expire on a region-by-region basis upon the latest of patent expiration, regulatory exclusivity expiration, or a specified number of years from the first commercial sale in that region.

Finance: review Q4 2025 cash burn against runway projection into Q1 2026 by next Tuesday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Customer Segments

You're looking at the core patient and provider base for Lyra Therapeutics, Inc. as they push LYR-210 toward final regulatory steps. The numbers tell a clear story about the size of the unmet need they are targeting.

Adult Chronic Rhinosinusitis (CRS) patients who have failed medical management

The addressable population here is substantial. Lyra Therapeutics, Inc. is focused on the estimated four million CRS patients in the United States who fail medical management each year. Overall CRS affects ~12% of the US population, with approximately ~8M patients treated annually. The total annual healthcare expenditure related to CRS is pegged at ~$60B. This segment represents patients who require further intervention beyond standard therapies.

CRS patients without nasal polyps (CRSsNP), the current primary focus

This is where the near-term regulatory focus lies, following the positive ENLIGHTEN 2 Phase 3 trial results announced in June 2025. The CRSsNP subtype is the larger group within the CRS spectrum, accounting for approximately ~70% of all CRS patients. The ENLIGHTEN 2 trial specifically met its primary endpoint in this non-polyp patient group at week 24. However, the path to market for this indication requires an additional confirmatory Phase 3 clinical trial, as confirmed after the September 2025 FDA meeting.

Here's a quick look at the CRS breakdown based on available data:

CRS Subtype	Approximate Percentage of Total CRS Patients	Key Product Focus/Data Point
CRS without Nasal Polyps (CRSsNP)	~70%	Primary focus of ENLIGHTEN 2 trial success
CRS with Nasal Polyps (CRSwNP)	~30%	Pooled data from ENLIGHTEN 1 and 2 showed positive trends

ENT specialists and Rhinologists who perform in-office procedures

The delivery mechanism for LYR-210 dictates a key customer segment: the physicians who perform the administration. LYR-210 is a bioabsorbable nasal implant designed to be inserted in a simple, in-office procedure, delivering 6 months of continuous anti-inflammatory therapy (7500µg mometasone furoate). This procedure-based delivery targets specialists comfortable with in-office sinus interventions. Lyra Therapeutics, Inc.'s operations manage its business as a single operating segment focused on Ear, Nose, and Throat (ENT) diseases, meaning the entire commercial effort is geared toward this provider base.

The treatment profile for the two main product candidates targets different procedural settings:

• LYR-210: Designed for surgically naïve patients.
• LYR-220: An enlarged implant being evaluated in the BEACON Phase 2 trial for patients with recurrent symptoms despite prior ethmoid sinus surgery.

Healthcare payers and insurance providers for reimbursement coverage

Payers are critical gatekeepers for access, especially given the high unmet need and the estimated ~$60B annual healthcare expenditure for CRS. The company's financial standing provides context for their near-term focus on securing coverage. As of September 30, 2025, Lyra Therapeutics, Inc. reported cash and cash equivalents of $22.1 million, with an anticipation that this balance will fund operations into the third quarter of 2026. The net loss for Q3 2025 was $6.0 million, and the trailing twelve-month revenue as of September 30, 2025, was $600K. Securing favorable coverage policies from third-party payors, including Medicare and Medicaid, will be essential to realizing the value from the targeted patient population.

Key financial metrics influencing payer negotiations as of late 2025:

• Cash on Hand (Sep 30, 2025): $22.1 million.
• Projected Cash Runway: Into Q3 2026.
• Q3 2025 Net Loss: $6.0 million.
• Market Capitalization (Nov 7, 2025): $7.58M.

Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Lyra Therapeutics, Inc.'s (LYRA) operations as of late 2025, which clearly shows a company streamlining after major clinical milestones and workforce adjustments. The focus is tight, centered on advancing the next critical step for LYR-210.

The most recent reported quarterly figures from the third quarter of 2025 give you a clear picture of the current cost base. You can see the impact of wrapping up the ENLIGHTEN 2 trial and the lingering effect of the 2024 workforce changes.

Cost Category	Amount (Q3 2025)	Context
Research and development expenses	$4.0 million	For the three months ended September 30, 2025.
General and administrative expenses	$2.2 million	For the three months ended September 30, 2025.
Net Loss	$6.0 million	For the third quarter of 2025.
Cash and cash equivalents	$22.1 million	As of September 30, 2025.

The Research and Development (R&D) spend for Q3 2025 was $4.0 million, a significant drop from $5.9 million in the same period in 2024. This reduction is directly tied to the completion of prior studies and ongoing lean operations.

Here's how the R&D costs broke down for the three months ended September 30, 2025:

• Decrease in clinical related costs of $2.1 million due to the completion of the ENLIGHTEN 2 trial for LYR-210.
• Increase in product development and manufacturing costs of $0.1 million.
• Decrease in employee related costs of $0.1 million, reflecting the May 2024 reduction in force.
• Increase in professional and consulting fees of $0.2 million.

Clinical trial expenses for the new confirmatory Phase 3 study are the next major planned outlay, though the specific Q3 2025 charge related to starting this new trial isn't itemized; the reported R&D decrease was largely due to the completion of the ENLIGHTEN 2 trial. Lyra Therapeutics is now focused on putting the components in place for this next trial to support a New Drug Application (NDA) submission.

General and administrative (G&A) expenses were $2.2 million for Q3 2025, down from $3.9 million year-over-year. This reduction was primarily driven by lower personnel costs following the 2024 workforce reduction, specifically a decrease in employee related costs of $1.6 million within G&A. The company also incurred a restructuring credit of $21 thousand in Q3 2025, compared to a restructuring charge of $2.8 million in Q3 2024 related to those earlier workforce adjustments.

Regarding manufacturing and quality control costs for LYR-210 supply, the most recent data shows a slight increase within R&D. Specifically, product development and manufacturing costs rose by $0.1 million in Q3 2025. This contrasts with the prior year, where product development and manufacturing costs had decreased by $1.0 million year-over-year for the full year 2024 as part of earlier cost-cutting measures, which included halting manufacturing efforts.

Personnel costs are definitely lower, as the May 2024 reduction in force continues to impact the expense base. You saw a $0.1 million reduction in R&D employee costs and a $1.6 million reduction in G&A employee costs for Q3 2025 alone compared to the prior year. Finance: draft 13-week cash view by Friday.

Lyra Therapeutics, Inc. (LYRA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Lyra Therapeutics, Inc. (LYRA) as of late 2025, and honestly, it's a picture of pre-commercial potential, heavily reliant on partnerships and financing to keep the lights on while LYR-210 moves through its final stages. Right now, the actual cash coming in from operations is minimal, which is typical for a clinical-stage biotech focused on a single asset.

The immediate, realized revenue is sparse, stemming almost entirely from existing agreements. You see this clearly in the latest quarterly filing.

• Collaboration revenue for the three months ended September 30, 2025, was reported at $25 thousand.
• For the nine months ended September 30, 2025, total collaboration revenue reached $391 thousand.

The company's cash position is being supplemented by capital markets activity. The June 2025 financing event provided a necessary cash infusion to support the path toward the New Drug Application (NDA) submission for LYR-210.

Here's a look at that recent equity raise:

Financing Event	Date	Gross Proceeds (Expected)	Estimated Net Proceeds
Registered Direct Offering & Concurrent Private Placement	June 2025	$5.0 million	Approximately $4.4 million

Future revenue is entirely contingent on the success of LYR-210, particularly the progress of the LianBio collaboration for Greater China and other Asian markets. Product sales revenue is currently zero, as the product is still investigational and awaiting regulatory approval.

The LianBio agreement is the primary driver of potential future non-dilutive funding. This partnership, which covers development and commercialization in key Asian territories, is structured around performance-based payments and ongoing sales participation. You should definitely track these milestones closely.

• Total potential milestone payments from LianBio are capped at up to $135 million, contingent on specified development, regulatory, and commercialization achievements.
• The initial upfront payment received upon execution of the agreement was $12.0 million.
• The company is also eligible for low double-digit royalties on net sales of LYR-210 achieved by LianBio in the licensed territories.

To be fair, the path to realizing those milestone payments and royalties is long, as it depends on regulatory success in multiple jurisdictions following the confirmatory Phase 3 trial for LYR-210. Finance: draft 13-week cash view by Friday.