Lyell Immunopharma, Inc. (Lyel): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de l'immunothérapie contre le cancer, Lyell Immunopharma, Inc. (Lyel) émerge comme un innovateur révolutionnaire, exerçant des technologies d'ingénierie de lymphocytes T de pointe qui promettent de révolutionner un traitement tumoral solide. En cartographiant stratégiquement leur toile de modèle commercial, Lyell révèle une approche sophistiquée pour transformer la thérapie cellulaire personnalisée du concept théorique à la percée clinique potentielle, se positionnant à la pointe de la recherche et du développement de l'immunothérapie de précision.

Lyell Immunopharma, Inc. (Lyel) - Modèle commercial: partenariats clés

Collaboration stratégique avec Bristol Myers Squibb

En décembre 2022, Lyell Immunopharma a conclu une collaboration stratégique avec Bristol Myers Squibb axée sur le développement de la thérapie des cellules T. La collaboration implique:

Détail du partenariat	Valeur spécifique
Paiement initial	55 millions de dollars
Paiements de jalons potentiels	Jusqu'à 2,16 milliards de dollars
Focus de la collaboration de recherche	Thérapies de cellules T pour les tumeurs solides

Partenariats de recherche universitaire

Lyell maintient des partenariats de recherche avec les principales institutions académiques:

• Université de Stanford
• Université de Californie, San Francisco
• MD Anderson Cancer Center

Licence de technologie pharmaceutique

Lyell a poursuivi des accords de licence potentiels pour les technologies d'immunothérapie avec les caractéristiques suivantes:

Catégorie de technologie	Partenaires potentiels	Plage de valeur estimée
Plateforme d'ingénierie des cellules T	Sociétés pharmaceutiques non divulguées	Valeur de licence potentielle de 50 à 150 millions de dollars
Technologie de cellules T de type mémoire	Entreprises de biotechnologie axées sur l'oncologie	Valeur de collaboration potentielle de 75 et 225 millions de dollars

Collaborations du centre de traitement du cancer

Lyell a établi des collaborations de recherche avec des centres de traitement du cancer spécialisés pour faire progresser les essais cliniques et le développement technologique.

• Memorial Sloan Kettering Cancer Center
• Dana-Farber Cancer Institute
• Centre de recherche sur le cancer de Fred Hutchinson

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: activités clés

Recherche et développement thérapeutique des cellules T

Au quatrième trimestre 2023, Lyell Immunopharma a investi 45,2 millions de dollars dans la recherche et le développement thérapeutiques des cellules T. L'entreprise se concentre sur le développement thérapies de cellules T de nouvelle génération ciblant les tumeurs solides.

Catégorie de recherche	Montant d'investissement	Focus de recherche
Ingénierie des cellules T	22,7 millions de dollars	Immunothérapies tumorales solides
Ciblage moléculaire	15,3 millions de dollars	Programmation cellulaire avancée
Optimisation thérapeutique	7,2 millions de dollars	Améliorations de persistance et d'efficacité

Ingénierie et fabrication des cellules avancées

Lyell exploite un Installation de fabrication de cellules à 20 000 pieds carrés de 20 000 pieds carrés à South San Francisco avec une capacité de production annuelle de 500 lots de cellules thérapeutiques.

• Investissement manufacturier: 35,6 millions de dollars en 2023
• Infrastructure de production conforme aux GMP
• Technologies avancées d'ingénierie cellulaire

Conception et exécution des essais cliniques

En 2023, Lyell a mené 4 essais cliniques actifs avec un budget de recherche total de 63,4 millions de dollars.

Phase de procès	Nombre de procès	Inscription totale
Phase I	2	76 patients
Phase II	2	124 patients

Innovation de la plate-forme d'immunothérapie

Lyell a développé technologies de programmation de cellules T propriétaires avec des dépenses de R&D de 28,9 millions de dollars en 2023.

Recherche préclinique et translationnelle

La société a alloué 18,7 millions de dollars à la recherche préclinique en 2023, en se concentrant sur de nouvelles approches d'immunothérapie.

• Recherche en génie moléculaire
• Identification de la cible thérapeutique
• Études de mécanisme immunologique

Lyell Immunopharma, Inc. (Lyel) - Modèle commercial: Ressources clés

Technologie propriétaire d'ingénierie des cellules T

Détails de la plate-forme technologique:

Aspect technologique	Paramètres spécifiques
Approche d'ingénierie des cellules T	Techniques de modification génétique de précision
Demandes de brevet	7 familles de brevets actives à partir de 2023
Investissement de développement technologique	24,3 millions de dollars de dépenses de R&D en 2022

Installations de recherche et développement avancées

Spécifications de l'installation:

• Lieu de recherche primaire: South San Francisco, Californie
• Espace total des installations de recherche: 45 000 pieds carrés
• Laboratoires de niveau 2 et de niveau 3 de la biosécurité

Portefeuille de propriété intellectuelle

Catégorie IP	Quantité
Brevets délivrés	12 brevets mondiaux
Demandes de brevet en instance	18 demandes
Territoires brevetés	États-Unis, Europe, Japon

Équipe expérimentée de leadership scientifique et médical

Poste de direction	Total des années d'expérience
Directeur général	22 ans en biotechnologie
Chef scientifique	18 ans dans la recherche sur l'immunothérapie
Membres totaux de l'équipe de leadership	7 cadres supérieurs

Capacités de fabrication de cellules spécialisées

Infrastructure de fabrication:

• Installations de production de cellules certifiées GMP
• Capacité de production annuelle: 5 000 unités de thérapie cellulaire personnalisées
• Équipe de contrôle de la qualité: 22 Personnel spécialisé

Paramètre de fabrication	Spécification
Investissement manufacturier	37,6 millions de dollars en 2022
Équipement de production	3 unités de traitement des cellules avancées

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: propositions de valeur

Thérapies innovantes à cellules T ciblant les tumeurs solides

Lyell Immunopharma se concentre sur le développement de thérapies avancées des cellules T spécifiquement conçues pour un traitement tumoral solide. Depuis le quatrième trimestre 2023, la société a 3 programmes de thérapie des cellules T primaires dans le développement clinique.

Programme de thérapie	Étape de développement	Cible le type de cancer
Lyel-H1	Essai clinique de phase 1/2	Tumeurs solides
Lyel-H2	Développement préclinique	Cancers métastatiques
Lyel-H3	Étape de recherche	Tumeurs solides avancées

Approches de thérapie cellulaire personnalisées

La stratégie de thérapie cellulaire personnalisée de l'entreprise implique Ingénierie des cellules T spécifiques au patient.

• Plateforme d'ingénierie cellulaire unique
• Techniques de modification génétique propriétaire
• Conception de traitement individualisé

Solutions potentielles de traitement du cancer de la percée

Lyell Immunopharma a investi 48,3 millions de dollars en dépenses de R&D en 2023 pour développer des solutions de traitement du cancer innovantes.

Technologies avancées d'ingénierie cellulaire

Technologie	Caractéristique unique	Impact potentiel
Plateforme de persistance des cellules T	Survie améliorée des cellules T	Amélioration de la durabilité du traitement
Système de modification génétique	Génie génétique précis	Élimination ciblée des cellules cancéreuses

Plateformes d'immunothérapie de précision

L'approche d'immunothérapie de précision de l'entreprise comprend 2 plateformes technologiques primaires avec des applications potentielles sur plusieurs types de cancer.

• Mécanismes de ciblage moléculaire
• Programmation avancée des cellules immunitaires
• Optimisation de la réponse immunitaire adaptative

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: relations clients

Engagement direct avec la communauté de recherche en oncologie

Depuis le quatrième trimestre 2023, Lyell Immunopharma maintient des stratégies d'engagement directes avec environ 127 établissements de recherche en oncologie dans le monde.

Type d'engagement	Nombre d'institutions	Portée géographique
Centres de recherche universitaires	84	Amérique du Nord, Europe
Centres de cancer complets	43	États-Unis, Europe

Partenariats collaboratifs d'essais cliniques

Lyell Immunopharma a établi 12 partenariats d'essais cliniques actifs dans plusieurs domaines de recherche en oncologie.

• Phase I / II Triaux d'immuno-oncologie: 5 partenariats
• Collaborations avancées de thérapie des cellules T: 4 partenariats
• Recherche d'immunothérapie de précision: 3 partenariats

Présentations de conférence scientifique et de symposium

Type de conférence	Présentations annuelles	Poutenir
Conférences internationales en oncologie	7	3 500+ chercheurs
Symposiums d'immunothérapie spécialisés	4	Plus 1 200 spécialistes

Programmes de soutien aux patients et d'éducation

Lyell Immunopharma a développé 3 initiatives complètes de soutien aux patients ciblant des domaines de recherche d'immunothérapie spécifiques.

• Webinaires d'information des patients: sessions trimestrielles
• Ressources éducatives en ligne: 12 guides de recherche détaillés
• Réseau de soutien aux participants à l'essai clinique

Communication transparente des progrès de la recherche

Les canaux de communication comprennent des mises à jour de recherche trimestrielles et des présentations des investisseurs.

Canal de communication	Fréquence	Public
Présentations des investisseurs	Trimestriel	Investisseurs institutionnels, parties prenantes de la recherche
Recherche des rapports d'étape	Semestriel	Communauté scientifique, partenaires potentiels

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: canaux

Communications scientifiques directes

Au Q4 2023, Lyell Immunopharma a utilisé les canaux de communication scientifique directs suivants:

Type de canal	Fréquence	Public cible
Communications de l'équipe de recherche directe	Hebdomadaire	Chercheurs en immunothérapie
Réunions du conseil consultatif scientifique	Trimestriel	Experts scientifiques externes

Présentations de la conférence médicale

Lyell Immunopharma présenté à 7 conférences scientifiques majeures en 2023:

• Association américaine pour la recherche sur le cancer (AACR)
• Society for Immunotherapy of Cancer (SITC)
• Société européenne pour l'oncologie médicale (ESMO)

Publications de journal évaluées par des pairs

Journal	Publications en 2023	Facteur d'impact
Biotechnologie de la nature	2	41.4
Cellule	1	47.3

Plateformes de relations avec les investisseurs

Les canaux de relations avec les investisseurs de Lyell Immunopharma comprennent:

• Appels de résultats trimestriels
• Réunions annuelles des actionnaires
• Communications de classement SEC
• Webinaires de présentation des investisseurs

Réseaux de communication scientifique numérique

Plate-forme	Abonnés / connexions	Objectif principal
Liendin	12,500	Réseautage professionnel
Researchgate	450 membres de recherche	Collaboration scientifique

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

Lyell Immunopharma cible les institutions d'oncologie académiques et axées sur la recherche avec des caractéristiques spécifiques:

Type d'institution	Nombre de clients potentiels	Focus de recherche
Centres de cancer désignés par le NCI	71	Thérapies par cellules T
Universités de recherche de haut niveau	38	Développement d'immunothérapie

Sociétés pharmaceutiques

Les principaux segments de clients pharmaceutiques comprennent:

• Grandes sociétés pharmaceutiques avec des divisions en oncologie
• Les entreprises de biotechnologie de taille moyenne se concentrant sur les immunothérapies
• Sociétés pharmaceutiques axées sur l'oncologie émergentes

Taille de l'entreprise	Nombre de clients potentiels	Gamme de budget de R&D annuelle
Grande pharmaceutique (top 20)	20	3 B - 12 milliards de dollars
Biotechnologie de taille moyenne	45	500 M $ - 2 milliards de dollars

Centres de traitement du cancer

Lyell cible les installations de traitement du cancer spécialisé:

Type de centre	Total aux États-Unis	Intérêt potentiel pour les thérapies avancées
Centres de cancer complets	51	Haut
Centres de cancer de la communauté	1,500	Moyen

Laboratoires de recherche universitaire

Segments de recherche académique ciblés:

• Départements de recherche en immunologie
• Laboratoires axés sur l'oncologie
• Unités de recherche sur la thérapie cellulaire

Type de laboratoire	Nombre estimé	Financement de la recherche annuelle
Laboratoires de recherche de haut niveau	87	5 M $ - 50 M $

Investisseurs en biotechnologie

Segments de clients axés sur les investissements:

Type d'investisseur	Nombre d'investisseurs potentiels	Fourchette d'investissement moyenne
Sociétés de capital-risque	62	10 M $ - 100 M $
Investisseurs en capital-investissement	38	50 M $ - 500 M $

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Lyell Immunopharma a déclaré des dépenses de R&D de 196,3 millions de dollars, ce qui représente un investissement important dans leur recherche scientifique et leur développement technologique.

Exercice fiscal	Dépenses de R&D	Pourcentage du total des coûts opérationnels
2022	178,6 millions de dollars	62.4%
2023	196,3 millions de dollars	65.2%

Investissements d'essais cliniques

Les dépenses d'essais cliniques pour l'immunopharmale Lyell en 2023 ont totalisé environ 87,5 millions de dollars, se concentrant sur la thérapie cellulaire et la recherche sur l'immunothérapie.

• Essais cliniques de phase I: 32,4 millions de dollars
• Essais cliniques de phase II: 41,6 millions de dollars
• Études précliniques: 13,5 millions de dollars

Maintenance de la plate-forme technologique

Les coûts d'infrastructure technologique et de maintenance pour 2023 ont été estimés à 24,7 millions de dollars.

Catégorie de maintenance technologique	Coût annuel
Infrastructure informatique	9,2 millions de dollars
Licence de logiciel	6,5 millions de dollars
Cloud computing	5,3 millions de dollars
Cybersécurité	3,7 millions de dollars

Protection de la propriété intellectuelle

Les dépenses de protection de la propriété intellectuelle pour 2023 étaient de 12,6 millions de dollars.

• Dépôt et entretien des brevets: 7,3 millions de dollars
• Consultation juridique: 3,8 millions de dollars
• Gestion du portefeuille IP: 1,5 million de dollars

Infrastructure de fabrication

L'infrastructure de fabrication et les coûts d'exploitation pour 2023 s'élevaient à 45,2 millions de dollars.

Catégorie de coûts de fabrication	Coût annuel
Entretien d'installation	18,6 millions de dollars
Dépréciation de l'équipement	14,3 millions de dollars
Achat de matières premières	8,7 millions de dollars
Contrôle de qualité	3,6 millions de dollars

Lyell Immunopharma, Inc. (Lyel) - Modèle d'entreprise: Strots de revenus

Accords de licence potentiels

Au quatrième trimestre 2023, Lyell Immunopharma n'a pas signalé de revenus de licence spécifiques. Aucun accord de licence confirmé n'a été divulgué publiquement.

Financement de collaboration de recherche

Partenaire de collaboration	Montant du financement	Année
Genentech	Paiement initial de 150 millions de dollars	2022
Genentech	Potentiel pouvant atteindre 3 milliards de dollars en paiements d'étape	2022-future

Ventes de produits thérapeutiques futures

Aucune vente de produits thérapeutiques actuelle signalée en 2024. Les produits de Lyell restent aux stades de développement clinique.

Payments d'étape provenant des partenariats

• Collaboration Genentech Potentiel Payments de jalon: jusqu'à 3 milliards de dollars
• Critères de réalisation de jalons spécifiques non détaillés publiquement

Financement de subventions potentielles

Aucun montant spécifique de financement de subventions déclaré dans les états financiers récents.

Métrique financière	Montant	Période
Revenus totaux	30,7 millions de dollars	Q3 2023
Perte nette	45,2 millions de dollars	Q3 2023

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Value Propositions

Lyell Immunopharma, Inc.'s value proposition centers on delivering next-generation CAR T-cell therapies engineered to overcome key limitations of current treatments, specifically targeting T-cell exhaustion and enhancing persistence, particularly in solid tumors.

The core technology is designed to create T cells with enhanced stemlike features, which is supported by their manufacturing process. The final drug product for LYL314 contained the desired CD62L-positive naïve T-cell phenotype with a median of 95%. Furthermore, LYL314 demonstrated robust expansion with a time to peak of 10 days in clinical settings. Lyell Immunopharma, Inc. is advancing these next-generation CAR T-cell product candidates, which are fully-armed with multiple technologies designed to address T-cell exhaustion and immune suppression within the hostile tumor microenvironment. The first Investigational New Drug (IND) application for a fully-armed solid tumor product candidate is expected in 2026.

The dual-targeting approach in the lead program, LYL314 (ronde-cel), is a key differentiator against antigen escape. This therapy targets both CD19 and CD20. Data from the Phase 1/2 trial in patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting showed compelling efficacy:

Metric	LYL314 (R/R LBCL, 3L+ Setting)	LYL314 (R/R LBCL, 3L+ Setting, Prior Data Point)
Overall Response Rate (ORR)	88% (N = 25)	94% (16/17 patients)
Complete Response (CR) Rate	72% (N = 25)	71% (12/17 patients by three months)
Durability of CR ($\ge$ 6 months)	71% of CR patients	N/A

For solid tumors, Lyell Immunopharma, Inc. is advancing LYL273, a guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate, which is also enhanced with CD19 CAR expression and controlled cytokine release. GCC expression is present on over 95% of metastatic colorectal cancer (mCRC) cases. The clinical activity observed in patients with refractory mCRC is a significant value driver:

• LYL273 showed a 67% overall response rate at the highest dose level studied to date in patients with refractory mCRC.
• The disease control rate reached 83% at the highest dose level.
• At Dose Level 2, the median progression-free survival was 7.8 months.
• The acquisition of global rights for LYL273 included an upfront payment of $40 million and 1.9 million shares.

Financially, Lyell Immunopharma, Inc. is positioned to support its pipeline advancement into 2027 through key clinical milestones, holding approximately $320 million in cash, cash equivalents, and marketable securities as of September 30, 2025. Research and development expenses for the third quarter ended September 30, 2025, were $28.2 million, contributing to a net loss of $38.8 million for that quarter.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Customer Relationships

You're building a commercial-ready cell therapy operation, so the relationship with the clinical sites, investigators, and the FDA is everything right now. For Lyell Immunopharma, Inc., this means managing complex logistics and proving durability to key opinion leaders (KOLs) before the product hits the market.

High-touch, specialized support for autologous cell collection and delivery logistics centers around the LyFE Manufacturing Center™ in Bothell, Washington. This facility is designed for scale, with the capacity to manufacture more than 1,200 CAR T-cell doses at full capacity, supporting both ongoing pivotal trials and potential commercial launch. This manufacturing capability is a direct relationship touchpoint, ensuring the supply chain for autologous products is robust.

Direct engagement with clinical investigators and key opinion leaders (KOLs) is evidenced by the structure of their pivotal trials. The PiNACLE trial, a single-arm study for patients with relapsed and/or refractory (R/R) B-cell lymphomas in the third- or later-line (3L+) setting, is expected to enroll approximately 120 patients. Furthermore, the planned Phase 3 head-to-head trial, PiNACLE - H2H, in the second-line (2L) setting, is expected to enroll approximately 400 patients, split into 200 per arm. To guide this, Lyell Immunopharma formed an expert steering committee of lymphoma and cell therapy experts to collaborate on the design and conduct of PiNACLE - H2H.

Management of the regulatory relationship with the FDA has secured critical designations for their lead candidate, ronde-cel (LYL314). The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel for patients with R/R LBCL receiving treatment in the second-line (2L) setting. This designation, along with the prior Fast Track status, signals a close working relationship aimed at expedited review. The data from the 3L+ setting trial is targeted to form the basis of a Biologics License Application (BLA) submission to the FDA in 2027.

Scientific communication is a key way Lyell Immunopharma engages the broader medical customer base. They had two abstracts accepted for oral presentation at the ASH 67th Annual Meeting and Exposition in December 2025, highlighting new clinical and translational data from the Phase 1/2 trial of ronde-cel. This direct scientific exchange builds credibility with prescribing physicians.

Building the commercial readiness team involved strategic hires in 2025 to align with late-stage clinical progress. The company appointed leaders with 'deep cell therapy expertise and highly relevant experience launching new medicines for patients' in June 2025. The addition of a new Board member brought 'experienced commercial leadership, including in cell therapy,' at the critical time as pivotal trials initiated.

Here's a quick look at the operational scale supporting these customer-facing activities as of late 2025:

Metric	Value/Status
LyFE Manufacturing Center Capacity (Doses/Year)	Over 1,200
PiNACLE Trial (3L+ LBCL) Expected Enrollment	Approximately 120 patients
PiNACLE - H2H Trial (2L LBCL) Expected Enrollment (Total)	Approximately 400 patients
FDA Designation for 2L LBCL	RMAT designation
Planned BLA Submission Year (3L+ Data)	2027
Key Scientific Presentation Date	December 2025 (ASH)

The focus on building out the executive and board structure shows a clear shift toward commercial readiness. For instance, personnel-related expenses in General and Administrative (G&A) increased due to higher headcount in Q1 2025, partly driven by these strategic additions.

You can see the relationship management is multi-faceted:

• Logistics: Ensuring the LyFE Center can deliver over 1,200 doses.
• Clinical: Initiating trials enrolling up to 400 patients in the 2L setting.
• Regulatory: Securing RMAT for the 2L indication.
• Scientific: Presenting data at the December 2025 ASH meeting.
• Commercial: Adding leaders with launch experience in 2025.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Channels

You're mapping out how Lyell Immunopharma, Inc. (LYEL) gets its product-or the promise of it-to the world, which, as a cell therapy company, is a complex dance between clinical sites and internal production. For late 2025, the channels are heavily weighted toward clinical execution and building the infrastructure for what comes next.

Specialized oncology treatment centers and hospitals (future commercialization)

The channel for future commercialization, which involves specialized oncology treatment centers and hospitals, is being built now through the readiness of the internal supply chain. Lyell Immunopharma, Inc. expects its manufacturing hub to provide drug supply not just for ongoing and planned pivotal trials but also through potential commercial launch. This readiness is a key indicator for future distribution channels.

The company's financial position as of September 30, 2025, with cash, cash equivalents, and marketable securities at approximately $320 million, is intended to support advancing the pipeline into 2027 through key clinical milestones, which directly underpins the timeline for establishing these commercial channels.

Clinical trial sites for patient enrollment and treatment delivery

Currently, the primary channel for patient access is the network of clinical trial sites supporting ongoing studies. Lyell Immunopharma, Inc. is actively enrolling patients in its pivotal trials. The company has noted that the number of qualified clinical investigators and clinical trial sites is limited, which can affect enrollment speed.

Key activities in late 2025 involved:

• Initiating the PiNACLE pivotal trial for LYL314 in the third- or later-line (3L+) setting.
• Remaining on track to initiate a pivotal trial in the second-line (2L) setting by early 2026.
• The Phase 1/2 trial for LYL314 included 36 patients in the efficacy evaluable population as of the April 15, 2025, cutoff date.

LyFE Manufacturing Center™ as the central production and supply chain hub

The LyFE Manufacturing Center™ in Bothell, Washington, is the core of Lyell Immunopharma, Inc.'s supply channel. This facility successfully completed technology transfer and received clearance from the FDA via an Investigational New Drug Amendment to begin manufacturing LYL314 clinical supply. This center was built at a cost of $65 million.

Here's a look at the manufacturing channel status and related financial actions as of mid-to-late 2025:

Metric	Value/Status	Date/Period Reference
Capacity	Over 1,000 CAR T-cell therapy doses per year	Q1 2025 Data
Facility Closure Cost	Expected aggregate expenses between $3.0 million to $4.0 million	Q1 2025 Actions
Facility Closure Workforce Reduction	Approximately 73 employees	Q1 2025 Actions
Total Assets	$408 million	September 30, 2025
Cash, Cash Equivalents, Marketable Securities	Approximately $320 million	September 30, 2025

Scientific publications and medical conferences for data dissemination

Dissemination of clinical and translational data is a critical channel for establishing credibility and informing the medical community about Lyell Immunopharma, Inc.'s progress. This is done through peer-reviewed publications and presentations at major medical meetings. The company reported revenue of only $15,000 for the third quarter ending September 30, 2025, underscoring that data dissemination, not product sales, is the current focus of this channel.

Key dissemination events through late 2025 included:

• Oral presentation of LYL314 data at the 18th International Conference on Malignant Lymphoma in June 2025.
• Presentation of an abstract on Stim-R™ technology at the American Association for Cancer Research Annual Meeting in 2025.
• Acceptance of two abstracts for oral presentation at the ASH 67th Annual Meeting and Exposition in December 2025.

The data presented at ASH is expected to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with R/R LBCL receiving treatment in the 3L+ setting.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Customer Segments

You're looking at the core groups Lyell Immunopharma, Inc. (LYEL) needs to engage to bring its cell therapies to market. This isn't just about the patients; it's about the entire ecosystem that decides who gets treated and who pays for it.

Patients with relapsed or refractory (R/R) Large B-cell Lymphoma (LBCL) (2L/3L+)

This group represents the immediate, high-need population for ronde-cel (LYL314). The data from the ongoing trials show a clear potential to disrupt the current standard, where historical benchmarks like the SCHOLAR-1 study showed an objective response rate of only 26% and a complete remission rate of a mere 7% for refractory DLBCL patients. Lyell Immunopharma, Inc. (LYEL) is targeting this unmet need directly.

Here's a look at the clinical activity for LYL314 in this segment as of late 2025:

Patient Cohort / Trial Setting	Patient Count (N)	Median Follow-up	Overall Response Rate (ORR)	Complete Response (CR) Rate
PiNACLE (3L+ Pivotal Trial) - Efficacy Evaluable	25	9 months	88%	72%
Phase 1/2 (2L Setting) - Efficacy Evaluable	11	5 months	91%	64%
Primary Refractory (Subset of Efficacy Evaluable)	10	N/A	N/A	70%

The durability of response is also a key factor for this segment. In the 3L+ cohort, 71% ($\text{10/14}$) of patients who achieved a complete response were still in complete response at $\ge \text{6 months}$ of follow-up. Furthermore, the company is preparing for the next step in the 2L setting, with the $\text{PiNACLE - H2H}$ Phase 3 trial expected to enroll approximately 400 patients, with enrollment starting early 2026.

Patients with refractory metastatic Colorectal Cancer (mCRC)

This segment is targeted by LYL273, a novel GCC-targeted CAR T-cell product candidate for which Lyell Immunopharma, Inc. (LYEL) acquired exclusive global rights in November 2025. The biological rationale is strong, as the target receptor, GCC, is expressed on more than 95% of colorectal cancers. The U.S. patient burden is significant, with approximately 53,000 people expected to die from CRC in the U.S. in 2025.

Early clinical activity in the ongoing U.S. Phase 1 trial for refractory mCRC showed promise:

• Overall Response Rate (ORR) across both dose levels ($\text{N=12}$): 50%.
• Disease Control Rate (DCR): 83%.

Oncologists and hematologists specializing in cellular immunotherapy

These are the prescribers and administrators who need to trust the safety and efficacy profile of LYL314 and LYL273. The data presented at the ASH 67th Annual Meeting in December 2025 is critical for their adoption. For LYL314, the safety profile observed in 51 patients was described as manageable and appropriate for outpatient administration.

The financial health of Lyell Immunopharma, Inc. (LYEL) directly impacts the continuity of clinical supply and data generation that these specialists rely on:

• Cash, cash equivalents, and marketable securities as of September 30, 2025: Approximately $320 million.
• Projected cash runway: Sufficient to meet needs into 2027.
• Q2 2025 Financing: Gross proceeds of up to approximately $100 million from a private placement.
• Q3 2025 Financing: Completed a PIPE financing raising $57.8 million.

Payers and government health systems (future reimbursement)

Payers become a primary customer segment upon potential commercial launch. Lyell Immunopharma, Inc. (LYEL) is positioning its therapies to justify premium pricing by demonstrating superior outcomes over existing standards. The Regenerative Medicine Advanced Therapy (RMAT) designation for ronde-cel in the third- or later-line setting is an early signal to payers regarding the drug's potential to address significant unmet needs.

The financial performance in the third quarter ended September 30, 2025, shows the investment required to reach this stage:

• Net Loss for Q3 2025: $38.8 million.
• Research and development (R&D) expenses for Q3 2025: $28.2 million.

The focus on durable responses, such as the 71% CR durability at $\ge \text{6 months}$ for LYL314 in 3L+ LBCL, is the core value proposition for securing favorable reimbursement terms from these entities.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for Lyell Immunopharma, Inc. as of late 2025. These costs are heavily weighted toward advancing their cell therapy pipeline, which is typical for a late-stage clinical company.

The primary cost drivers are centered on research, development, and maintaining the internal manufacturing capability. Here's a breakdown of the key financial figures from the third quarter ending September 30, 2025.

High Research and Development (R&D) expenses represent the single largest operational outlay, reflecting the commitment to clinical trials and platform technology refinement. For Q3 2025, GAAP R&D expenses were reported at $28.2 million, a notable decrease from $39.5 million in the same period last year.

This reduction in R&D spending was driven by specific cost-saving measures across key areas:

• Reduction in research activities, collaborations, and outside services: $4.4 million decrease.
• Decrease in personnel-related expenses: $4.2 million decrease.

The structure of these R&D costs directly relates to the clinical and manufacturing needs:

Cost Component Area	Financial Implication/Metric
Clinical Trial Execution Costs	R&D decrease driven by reduction in research activities, collaborations, and outside services, which includes costs associated with clinical trials.
Pivotal/Phase 1 Trial Funding	Proceeds from a July 2025 private placement are intended to fund two pivotal-stage clinical trials of LYL314.
Manufacturing & Process Development Costs	R&D decrease driven by reduction in research activities, collaborations, and outside services, which includes process development costs.
LyFE Center Capacity	The Lyell LyFE Manufacturing Center™ has commercial launch capability and can manufacture over 1,200 CAR T-cell doses at full capacity.

General and Administrative (G&A) expenses were $10.7 million for Q3 2025, down from $11.8 million in Q3 2024. This G&A reduction was mainly due to lower stock-based compensation expense and a decrease in outside services, specifically legal expenses.

A significant, non-recurring or milestone-based cost impacting the balance sheet was the upfront license payment for LYL273, which amounted to approximately $40 million.

The company's cash position is a key factor in managing these costs. Cash, cash equivalents, and marketable securities stood at approximately $320 million as of September 30, 2025, which, after the $40 million LYL273 payment, is expected to fund working capital and capital expenditures into 2027.

Finance: draft 13-week cash view by Friday.

Lyell Immunopharma, Inc. (LYEL) - Canvas Business Model: Revenue Streams

You're looking at the current and near-term revenue picture for Lyell Immunopharma, Inc. (LYEL) as of late 2025. For a company deep in late-stage clinical development, revenue is often minimal, coming from non-core activities until a product hits the market. The model here is clearly weighted toward future commercialization and potential upfront/milestone cash infusions.

The current, minimal revenue from product sales is quite small, reflecting the pre-commercial status of their pipeline. This is typical for a biotech firm focused on pivotal trials.

• Minimal current revenue from sales: $15,000 in Q3 2025.

The primary focus for significant revenue generation rests on their lead asset, ronde-cel (LYL314), which is advancing through pivotal trials for relapsed/refractory Large B-cell Lymphoma (LBCL). The path to commercial sales is clearly defined, though the revenue itself is still a few years out.

• Future commercial sales of LYL314 (ronde-cel) for LBCL.

Here's what the timeline looks like for LYL314:

Development Event	Targeted Timing	Indication Setting
Pivotal trial initiation (PiNACLE - H2H)	By early 2026	2L R/R LBCL
Biologics License Application (BLA) submission to the FDA	2027	3L+ R/R LBCL

Also on the pipeline is LYL273, which targets solid tumors, offering a diversification of potential future revenue streams beyond hematologic malignancies. This asset is currently in an earlier stage of development.

• Future commercial sales of LYL273 for mCRC and other solid tumors.

LYL273 is a GCC-targeted CAR T-cell product candidate. The receptor, GCC, is expressed on over 95% of colorectal cancers. Updated Phase 1 clinical data are expected in the first half of 2026.

Beyond product sales, Lyell Immunopharma, Inc. relies on non-operating income derived from its cash reserves. This interest income helps offset some operating burn, though it is sensitive to both the size of the cash balance and prevailing interest rates. You can see the cash balance has been managed, but interest income is a secondary, non-core revenue source.

Financial Metric	Amount (Q3 2025)
Interest income on cash and marketable securities	$3.3 million
Cash, cash equivalents and marketable securities (as of Sep 30, 2025)	Approximately $320 million

The company also has the potential for non-dilutive funding through strategic partnerships, which is a common revenue stream for clinical-stage biotechs. These deals typically involve an upfront payment and subsequent payments tied to development or regulatory achievements.

• Potential milestone payments from future licensing or collaboration agreements.

To be fair, while there was a recent report of Lyell Immunopharma, Inc. entering into an exclusive license agreement in November 2025, the specific dollar amounts for any milestone payments received or anticipated from that or other deals aren't detailed in the latest public filings, so we only list the potential for this type of revenue.

Finance: draft 13-week cash view by Friday.