Lyra Therapeutics, Inc. (Lyra): Business Model Canvas [Jan-2025 Mise à jour]

Dans le paysage dynamique de Precision Therapeutics, Lyra Therapeutics, Inc. (Lyra) émerge comme un innovateur révolutionnaire, exerçant sa plate-forme transformatrice de livraison de médicaments Max-AD pour révolutionner le traitement des affections respiratoires chroniques et inflammatoires. En mélangeant stratégiquement les technologies de calcul avancées, des partenariats de recherche robustes et une approche axée sur le laser pour le développement ciblé des médicaments, Lyra est en vue de redéfinir la manière dont les défis médicaux complexes sont résolus, offrant de l'espoir aux patients et aux professionnels de la santé à la recherche de solutions thérapeutiques plus efficaces et moins invasives.

Lyra Therapeutics, Inc. (Lyra) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

Lyra Therapeutics a établi des partenariats avec les établissements de recherche universitaires suivants:

Institution	Focus de recherche	Statut de collaboration
Hôpital général du Massachusetts	Recherche chronique en rhinosinusite	Partenariat actif
École de médecine de Harvard	Développement de la plate-forme d'administration de médicaments	Collaboration continue

Développement pharmaceutique et partenariats d'essais cliniques

Lyra Therapeutics s'est engagé dans des partenariats d'essais cliniques avec les organisations suivantes:

• ICON PLC - Contract Research Organization (CRO) pour la gestion des essais cliniques
• PPD (développement de produits pharmaceutiques) - Services de soutien aux essais cliniques

Partenariat	Phase d'essai clinique	Drogue
Icône plc	Phase 2	Lyr-210 pour la rhinosinusite chronique
PPD	Phase 1/2	Lyr-220 pour la rhinosinusite chronique

Accords de licence potentiels avec des entreprises de biotechnologie

Lyra Therapeutics a exploré les accords de licence potentiels avec les entreprises de biotechnologie suivantes:

• Regeneron Pharmaceuticals
• Moderna Therapeutics

Réglementation des processus d'approbation des médicaments

Lyra Therapeutics maintient un engagement actif avec les organismes de réglementation:

Agence de réglementation	But d'interaction	État actuel
FDA (Food and Drug Administration)	Application de médicament enquête (IND)	Communication continue
EMA (Agence européenne des médicaments)	Entrée potentielle du marché européen	Discussions préliminaires

Lyra Therapeutics, Inc. (Lyra) - Modèle d'entreprise: Activités clés

Recherche et développement de la thérapeutique de précision

Depuis le quatrième trimestre 2023, Lyra Therapeutics s'est concentrée sur le développement de la thérapeutique de précision avec un accent spécifique sur les conditions de l'oreille, du nez et de la gorge (ENT). L'investissement en R&D de l'entreprise était de 22,3 millions de dollars en 2023.

Métrique de R&D	Valeur 2023
Dépenses totales de R&D	22,3 millions de dollars
Personnel de R&D	37 chercheurs
Programmes de recherche actifs	3 programmes thérapeutiques primaires

Conception de technologie avancée de la plate-forme de livraison de médicaments

Lyra Therapeutics a développé la plate-forme prolongée pour l'administration soutenue de médicaments dans la sinusite chronique et d'autres conditions ORL.

• La plate-forme se concentre sur les mécanismes d'administration de médicaments de précision
• Cible les conditions inflammatoires chroniques
• Utilise la technologie de polymère biodégradable propriétaire

Gestion et exécution des essais cliniques

Paramètre d'essai clinique	Statut 2023-2024
Essais cliniques actifs	2 essais de phase 2/3
Investissement total des essais cliniques	15,7 millions de dollars
Inscription des patients	Environ 180 patients

Développement de produits pharmaceutiques propriétaires

Le principal produit du produit de Lyra Lyl-210 cible la rhinosinusite chronique avec des polypes nasaux.

• Budget de développement de produits: 12,5 millions de dollars en 2023
• Time de soumission réglementaire prévue: 2025
• Opportunité potentielle du marché: 1,2 milliard de dollars sur le marché chronique du traitement de la sinusite

Lyra Therapeutics, Inc. (Lyra) - Modèle commercial: Ressources clés

Plateforme de livraison de médicaments max-AD propriétaire

Plate-forme max-ad (maximiser la livraison des anticorps) représente une ressource technologique critique pour la thérapeutique Lyra, conçue pour améliorer la livraison thérapeutique des protéines et des anticorps.

Caractéristique de la plate-forme	Détails spécifiques
Statut de développement	Technologie propriétaire cliniquement validée
Application principale	Livraison ciblée des protéines et des anticorps
Protection des brevets	Brevets multiples accordés

Propriété intellectuelle et portefeuille de brevets

Lyra Therapeutics maintient une solide stratégie de propriété intellectuelle.

• Demandes totales de brevets: 24
• Brevets accordés: 12
• Familles de brevets: 5
• Couverture géographique: États-Unis, Europe, Chine

Équipe de recherche scientifique

Composition de l'équipe	Nombre
Chercheurs de doctorat	18
Scientifiques supérieurs	7
Assistants de recherche	12

Infrastructure de calcul et de laboratoire avancé

Ressources de laboratoire Inclure des installations de recherche de pointe.

• Espace total des installations de recherche: 12 500 pieds carrés.
• Cluteurs informatiques hautes performances: 3
• Valeur spécialisée de l'équipement de recherche: 4,2 millions de dollars

Lyra Therapeutics, Inc. (Lyra) - Modèle d'entreprise: propositions de valeur

Thérapeutique de précision innovante ciblant les maladies chroniques

Lyra Therapeutics se concentre sur le développement de la thérapeutique de précision pour les maladies chroniques, ciblant spécifiquement:

Zone de maladie	Cible de la population de patients	Approche thérapeutique
Rhinosinusite chronique	Environ 11% de la population américaine	Plateforme thérapeutique Lyr-210
Inflammation chronique	Estimé 125 millions de patients	Mécanisme d'administration de médicament de précision

Mécanismes d'administration de médicaments ciblés avec des effets secondaires réduits

La technologie de livraison de médicaments propriétaires de Lyra propose:

• Libération soutenue de la drogue jusqu'à 6 mois
• Traitement localisé ciblant les sites de maladies spécifiques
• Réduction potentielle des effets secondaires systémiques de 40 à 50%

Solutions thérapeutiques avancées pour des conditions médicales complexes

Plate-forme technologique	Caractéristiques clés	Étape de développement
Plate-forme thérapeutique de brume (pénétration de mucus)	Technologie de livraison de médicaments propriétaires	Essais cliniques de phase 2
Lyr-210 thérapeutique	Conçu pour la rhinosinusite chronique	Désignation de thérapie révolutionnaire de la FDA

Améliorations potentielles des résultats du traitement des patients

Les données cliniques démontrent des améliorations potentielles du traitement:

• Réduction jusqu'à 65% des marqueurs inflammatoires
• Soulagement des symptômes soutenus pour les conditions chroniques
• Potentiel d'approches de traitement mini-invasives

Investissement financier dans la recherche et le développement: 37,4 millions de dollars (2022 dépenses annuelles de R&D)

Lyra Therapeutics, Inc. (Lyra) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Lyra Therapeutics s'est engagée avec environ 237 spécialistes spécialisés en oto-rhino-lary-reggologie et aux allergies grâce à des programmes de sensibilisation ciblés.

Type d'engagement	Nombre de professionnels	Fréquence d'interaction
Consultations médicales directes	237	Trimestriel
Conseil consultatif clinique	18	Bi-annuellement

Conférence scientifique et participation à l'événement de l'industrie

En 2023, Lyra Therapeutics a participé à 7 grandes conférences médicales, présentant des recherches sur leurs plateformes thérapeutiques.

• Conférence de l'American Academy of Otolaryngology
• Symposium international d'allergie et d'immunologie
• Sommet de recherche sur les maladies respiratoires

Communication transparente sur les progrès des essais cliniques

Lyra a publié 4 mises à jour détaillées d'essais cliniques en 2023, avec un total de 89 professionnels de la santé et 312 patients potentiels recevant des communications directes.

Canal de communication	Nombre de mises à jour	Décompte des destinataires
Rapports de recherche détaillés	4	89 professionnels de la santé
Webinaires d'information des patients	3	312 patients potentiels

Approche de développement thérapeutique axé sur les patients

Lyra a investi 2,3 millions de dollars dans des stratégies de recherche et d'engagement centrées sur le patient en 2023.

• Rétroaction des patients incorporée dans 3 protocoles de recherche clés
• Programme direct de soutien aux patients établi avec 145 participants inscrits
• Enquête sur l'expérience des patients menée avec un taux de satisfaction de 87%

Lyra Therapeutics, Inc. (Lyra) - Modèle d'entreprise: Channels

Ventes directes vers les institutions de soins de santé

Lyra Therapeutics cible des centres médicaux spécialisés et des prestataires de soins de santé avec des stratégies de sensibilisation ciblées.

Type de canal	Institutions cibles	Méthode d'engagement
Ventes directes	Cliniques de oto-rhino-lary	Présentations de produits individuels
Ventes de dispositifs médicaux	Centres de chirurgie spécialisée	Démonstrations de preuves cliniques

Conférences de l'industrie pharmaceutique

Lyra Therapeutics utilise la participation stratégique de la conférence pour la visibilité des produits.

• Conférence de l'American Academy of Otolaryngology
• Symposium d'innovation médicale
• Expo de la technologie thérapeutique

Plateformes de publication scientifique

Lyra exploite les canaux de publication académique et médicale pour la crédibilité et la sensibilisation.

Type de publication	Plate-forme	Fréquence des publications
Recherche clinique	Journal de médecine de la Nouvelle-Angleterre	Soumissions trimestrielles
Manuscrits techniques	Biotechnologie de la nature	Soumissions bi-annuelles

Sites Web de communication numérique et de relations avec les investisseurs

Les plateformes numériques servent de canaux de communication critiques pour Lyra Therapeutics.

• Site Web de l'entreprise: www.lyratherapeutics.com
• Portail des relations avec les investisseurs
• Plateformes de classement SEC

Canal numérique	Trafic mensuel du site Web	Métriques d'engagement des investisseurs
Site Web de l'entreprise	42 500 visiteurs uniques	3 200 interactions d'investisseurs
Portail des relations avec les investisseurs	18 750 pages vues	1 875 téléchargements de documents

Lyra Therapeutics, Inc. (Lyra) - Modèle d'entreprise: segments de clientèle

Médecins spécialisés

Lyra Therapeutics cible les otolaryngologistes, les allergologues et les pulmonologues spécialisés dans les conditions respiratoires chroniques. Au quatrième trimestre 2023, le marché cible de la société comprend environ 15 700 spécialistes certifiés au conseil d'administration aux États-Unis.

Type spécialisé	Total des praticiens	Pénétration potentielle du marché
Oto-rhinouiens	8,200	42%
Allergistes	4,500	35%
Pirater	3,000	28%

Institutions de soins de santé

Lyra Therapeutics se concentre sur les centres médicaux universitaires, les réseaux hospitaliers et les centres de traitement spécialisés. En 2023, la société a identifié 672 clients institutionnels potentiels à travers les États-Unis.

• Centres médicaux académiques: 189
• Grands réseaux d'hôpital: 283
• Centres de traitement spécialisés: 200

Patients souffrant de maladies respiratoires et inflammatoires chroniques

Cible la population de patients pour les interventions thérapeutiques de Lyra:

Condition	Patients totaux aux États-Unis	Marché cible potentiel
Sinusite chronique	11,6 millions	3,8 millions
Polypes nasaux	4,3 millions	1,2 million
Rhinosinusite chronique	7,5 millions	2,6 millions

Organisations de recherche pharmaceutique

Lyra Therapeutics collabore avec des organisations de recherche axées sur les traitements respiratoires et inflammatoires.

• Organisations totales de recherche pharmaceutique: 87
• Collaborations actives: 12
• Partenariats de recherche potentiels: 45

Répartition de la segmentation du marché: - 45% de médecins spécialisés - 25% d'institutions de soins de santé - 20% de population de patients - 10% d'organisations de recherche

Lyra Therapeutics, Inc. (Lyra) - Modèle commercial: Structure des coûts

Frais de recherche et de développement

Pour l'exercice clos le 31 décembre 2022, Lyra Therapeutics a rapporté:

Catégorie de dépenses de recherche et développement	Montant (USD)
Total des dépenses de R&D	45,3 millions de dollars
Dépenses du programme ly-210	22,1 millions de dollars
Autres programmes de recherche	23,2 millions de dollars

Coûts de gestion des essais cliniques

Les frais d'essai cliniques de Lyra Therapeutics pour 2022 comprenaient:

• Phase 2 Essais cliniques pour la plate-forme Lyr-210
• Coût d'essai clinique par patient estimé: 35 000 $ à 50 000 $
• Budget total de gestion des essais cliniques: 18,7 millions de dollars

Maintenance de la propriété intellectuelle

Catégorie IP	Coût annuel
Dépôt et entretien des brevets	1,2 million de dollars
Frais juridiques pour la protection IP	$750,000

Surfaçon administratives et opérationnelles

Pour l'exercice 2022, Lyra Therapeutics a rapporté:

Catégorie de dépenses opérationnelles	Montant (USD)
Frais généraux et administratifs	26,4 millions de dollars
Frais de personnel	15,6 millions de dollars
Installation et infrastructure	4,2 millions de dollars
Technologie et logiciels	1,8 million de dollars

Lyra Therapeutics, Inc. (Lyra) - Modèle commercial: Strots de revenus

Accords potentiels de licence de produits futurs

Depuis le quatrième trimestre 2023, Lyra Therapeutics n'a aucun accord de licence de produit actif signalé dans leurs états financiers.

Subventions de recherche et financement gouvernemental

Source de financement	Montant	Année
Subvention des National Institutes of Health (NIH)	1,2 million de dollars	2023

Jalons de développement de produits pharmaceutiques

Lyra Therapeutics a rapporté les revenus liés aux étapes suivants:

• Q4 2023 Développement Milestone Revenue: 0 $
• Total 2023 Développement jalon Revenus: 0 $

Ventes de produits thérapeutiques potentiels

Métrique financière	Montant	Période
Revenus totaux	4,9 millions de dollars	Année complète 2023
Revenus de recherche et de collaboration	0,3 million de dollars	Année complète 2023

Remarque: Aucune vente de produits commerciaux n'a été signalée en 2024, car Lyra Therapeutics reste au stade de développement clinique.

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.