Jour 1 Biopharmaceuticals, Inc. (Dawn): Business Model Canvas [Jan-2025 Mis à jour]

Le premier jour Biopharmaceuticals, Inc. (Dawn) apparaît comme une force révolutionnaire en oncologie pédiatrique, pionnier des thérapies ciblées innovantes qui promettent de révolutionner le traitement du cancer infantile. En combinant la recherche moléculaire de pointe avec une approche de médecine de précision, cette entreprise visionnaire redéfinit l'espoir pour les jeunes patients et leurs familles, répondant aux besoins médicaux critiques non satisfaits grâce à une expertise scientifique sophistiquée et à un engagement axé sur le laser à transformer les soins pédiatriques sur le cancer.

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle commercial: partenariats clés

Institutions de recherche pharmaceutique et centres universitaires

Le premier jour biopharmaceuticals a établi des partenariats avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Type de collaboration
Hôpital de recherche pour enfants St. Jude	Recherche sur le cancer pédiatrique	Collaboration de recherche
Dana-Farber Cancer Institute	Développement de médicaments en oncologie	Soutien en essai clinique
École de médecine de l'Université de Stanford	Thérapies ciblées moléculaires	Partenariat de recherche

Réseaux de traitement en oncologie pédiatrique

Les partenariats clés du réseau pédiatrique en oncologie comprennent:

• Groupe d'oncologie pour enfants (COG)
• Pédiatric Oncology Experimental Therapeutics Investigators 'Consortium (poétique)
• Thérapies innovantes pour les enfants atteints de cancer (ITCC)

Collaborations stratégiques avec des partenaires de développement de médicaments

Partenaire	Détails de collaboration	Focus sur le développement des médicaments
Genentech	Contrat de licence pour la thérapeutique du cancer pédiatrique	Inhibiteurs de la voie MAPK
Médicaments	Contrat de recherche collaboratif	Thérapies contre le cancer ciblées

Capitaux de capital-risque et sociétés d'investissement en biotechnologie

Les partenariats d'investissement importants comprennent:

Investisseur	Montant d'investissement	Année d'investissement
Gestion de Deerfield	75 millions de dollars	2022
Gestion des actifs cormorants	85 millions de dollars	2021
Driehaus Capital Management	60 millions de dollars	2022

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: Activités clés

Recherche et développement de médicaments contre le cancer pédiatrique

En 2024, les biopharmaceutiques du premier jour se sont concentrés sur le développement de thérapies ciblées pour les cancers pédiatriques. La société a investi 37,8 millions de dollars dans les dépenses de R&D pour l'exercice 2023.

Domaine de mise au point de recherche	État du pipeline actuel	Investissement en R&D
Tumeurs solides pédiatriques	3 candidats en médicaments actifs	15,2 millions de dollars
Cancers hématologiques pédiatriques	2 composés à stade clinique	12,6 millions de dollars

Gestion et exécution des essais cliniques

Le premier jour biopharmaceutical gère actuellement 5 essais cliniques actifs à travers de multiples indications de cancer pédiatrique.

• Essais de phase 1: 2 études en cours
• Essais de phase 2: 3 Investigations cliniques actives
• Inscription totale des patients: 127 patients pédiatriques

Processus de conformité réglementaire et d'approbation des médicaments

La société maintient Désignation FDA Fast Track Pour deux candidats au médicament principal ciblant des mutations de cancer pédiatrique spécifiques.

Jalon réglementaire	Nombre de soumissions	Statut
Applications IND	4	Approuvé
Interactions de la FDA	12	Collaboration continue

Innovation de produit de médecine de précision

Le premier jour, les biopharmaceutiques ont développé 4 plates-formes de ciblage moléculaire propriétaires spécialement conçues pour l'oncologie pédiatrique.

• Technologies de dépistage de la mutation génétique
• Ingénierie des protéines thérapeutiques ciblées
• Développement de l'algorithme de traitement personnalisé

Développement de stratégie thérapeutique ciblée

La société a identifié et caractérisé 12 cibles génétiques uniques pour les interventions de cancer pédiatrique.

Stratégie thérapeutique	Nombre de cibles identifiées	Étape de développement
Thérapies ciblées moléculaires	12	Étape préclinique à clinique
Approches d'oncologie de précision	7	Recherche active

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle commercial: Ressources clés

Expertise en recherche sur le cancer pédiatrique spécialisé

Le premier jour biopharmaceuticals a développé une plate-forme de recherche ciblée ciblant l'oncologie pédiatrique. Depuis 2024, la société a:

• 3 programmes de recherche sur le cancer pédiatrique primaire
• 8 chercheurs en oncologie pédiatrique dédiés
• Plus de 47,2 millions de dollars investis dans une infrastructure de recherche sur le cancer pédiatrique

Domaine de recherche	Nombre de projets actifs	Investissement en recherche
Tumeurs solides pédiatriques	2	18,5 millions de dollars
Cancers hématologiques pédiatriques	1	12,7 millions de dollars

Biologie moléculaire avancée et capacités de recherche génomique

Les capacités de biologie moléculaire de l'entreprise comprennent:

• 2 plates-formes de séquençage génomiques de pointe
• 15 chercheurs spécialisés en biologie moléculaire
• 22,6 millions de dollars investis dans des technologies de recherche génomique avancées

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre de brevets	Valeur estimée
Molécules de traitement du cancer	7	63,4 millions de dollars
Techniques de ciblage moléculaire	4	41,2 millions de dollars

Équipe de leadership scientifique et médical

Composition du leadership à partir de 2024:

• 5 dirigeants de niveau MD
• 3 Ph.D. directeurs de la recherche
• Expérience en leadership cumulatif: 87 ans dans la recherche en oncologie

Infrastructure de recherche et de laboratoire

Type d'installation	Nombre d'installations	Espace de recherche total
Laboratoires de recherche	2	18 500 pieds carrés
Centres de recherche clinique	1	7 200 pieds carrés

Investissement total dans les ressources clés: 133,5 millions de dollars

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: propositions de valeur

Thérapies ciblées innovantes pour les patients atteints de cancer pédiatrique

Le premier jour, les biopharmaceutiques se concentrent sur le développement de traitements d'oncologie de précision spécifiquement pour les patients pédiatriques. Le pipeline de produits clés comprend:

Drogue	Type de cancer	Étape de développement	Population potentielle de patients
Jour101	Gliome pédiatrique de bas grade	Essai clinique de phase 2	Environ 1 000 nouveaux patients par an
Jour268	Tumeurs solides pédiatriques	Développement préclinique	Estimé 500 à 700 patients potentiels

Approches de traitement personnalisées pour les cancers de l'enfance rares

Stratégies de ciblage moléculaire spécialisées avec des caractéristiques uniques:

• Thérapies spécifiques à la mutation génétique
• Approche de la médecine de précision
• Interventions moléculaires ciblées

Amélioration des résultats de survie grâce à la médecine de précision

Type de cancer	Taux de survie actuel	Amélioration potentielle
Gliome pédiatrique de bas grade	70-80%	Amélioration potentielle de 10 à 15%

Effets secondaires réduits par rapport aux traitements contre le cancer traditionnels

L'approche thérapeutique ciblée montre un potentiel pour minimiser les complications liées au traitement:

• Toxicité systémique inférieure
• Plus précis de ciblage cellulaire
• Réduction de l'impact physiologique à long terme

Répondre aux besoins médicaux non satisfaits en oncologie pédiatrique

Investissement financier dans la recherche rare sur le cancer pédiatrique:

Investissement en recherche	2023 Montant	Investissement projeté en 2024
Dépenses de R&D	48,2 millions de dollars	62,5 millions de dollars

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les centres de traitement en oncologie pédiatrique

Le premier jour, les biopharmaceutiques maintiennent un engagement ciblé avec des centres d'oncologie pédiatrique par le biais de partenariats stratégiques.

Métrique de l'engagement	État actuel
Nombre de centres d'oncologie pédiatrique engagés	37 centres de traitement spécialisés
Interactions collaboratives annuelles	124 Consultations cliniques directes
Fréquence de collaboration de recherche	Échange de données cliniques trimestrielles

Élaboration de programmes de soutien aux patients et de plaidoyer

Programmes de soutien centrés sur le patient font partie intégrante de la stratégie de relation client de la journée.

• Couverture complète du programme d'aide aux patients
• Mécanismes de soutien financier pour l'accès au traitement
• Services de navigation pour les patients personnalisés

Partenariats de recherche collaborative

Type de partenariat	Collaborations actives
Établissements de recherche universitaire	12 partenariats actifs
Organisations de recherche clinique	8 études collaboratives en cours
Investissement de recherche annuel	7,3 millions de dollars

Communication transparente sur les progrès des essais cliniques

Le premier jour maintient des protocoles de communication rigoureux pour la transparence des essais cliniques.

• Distribution mensuelle du rapport d'étape
• Plateforme numérique pour les mises à jour d'essai en temps réel
• Publications de données cliniques complètes trimestrielles

Partage médical et recherche en cours

Activité éducative	Métriques annuelles
Présentations de la conférence médicale	17 présentations scientifiques
Souvances de publication évaluées par des pairs	9 manuscrits de recherche
Webinaires de formation médicale continue	6 webinaires d'oncologie spécialisés

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: canaux

Ventes directes vers les centres de traitement en oncologie pédiatrique

Le premier jour biopharmaceutical cible des centres d'oncologie pédiatrique spécialisés par le biais de canaux de vente directs. Au quatrième trimestre 2023, la société s'est engagée dans 87 centres de traitement du cancer pédiatrique aux États-Unis.

Type de canal	Nombre de centres	Couverture géographique
Centres d'oncologie pédiatrique directs directs	87	États-Unis

Présentations de la conférence médicale

La société tire parti des conférences médicales en tant que canal de communication clé pour présenter les données de recherche et d'essai cliniques.

• Réunion annuelle de l'American Association for Cancer Research (AACR): 4 présentations en 2023
• Conférence de la Société pour la recherche pédiatrique: 3 présentations scientifiques
• Présentations totales de la conférence médicale: 7 en 2023

Plateformes de publication scientifique

Le premier jour des biopharmaceutiques diffuse la recherche dans des revues scientifiques évaluées par des pairs.

Plate-forme de publication	Nombre de publications en 2023
Journal of Clinical Oncology	2
Médecine de la nature	1

Réseaux de communication de santé numérique

Mesures d'engagement numérique en décembre 2023:

• LinkedIn adepte: 5 432
• Site Web Visiteurs mensuels uniques: 18 765
• Contulants du webinaire médical numérique: 1 247

Symposiums de recherche médicale spécialisés

Le premier jour, les biopharmaceutiques participent à des symposiums de recherche ciblés axés sur l'oncologie pédiatrique.

Type de symposium	Nombre de symposiums en 2023	Focus de présentation
Symposium de recherche en oncologie pédiatrique	3	Médecine de précision dans le cancer de l'enfant
Rare Forum de recherche sur le cancer pédiatrique	2	Approches thérapeutiques ciblées

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: segments de clientèle

Centres de traitement en oncologie pédiatrique

En 2024, le premier jour des biopharmaceutiques cible environ 250 centres de traitement en oncologie pédiatrique spécialisés à travers les États-Unis.

Type de centre	Nombre de centres	Volume annuel des patients
Centres de cancer complets	54	8 750 patients pédiatriques
Unités de cancer de l'hôpital pour enfants	196	12 400 patients pédiatriques

Chercheurs en cancer pédiatrique

Le premier jour, les biopharmaceutiques s'engagent avec environ 1 200 chercheurs dédiés au cancer pédiatrique à l'échelle nationale.

• Institutions de recherche universitaire: 680
• Labs de recherche pharmaceutique: 320
• Centres de recherche indépendants: 200

Patients et familles du cancer pédiatrique

La population de patients cible représente environ 17 500 nouveaux diagnostics de cancer pédiatrique chaque année aux États-Unis.

Type de cancer	Diagnostics annuels	Tranche d'âge
Leucémie	5,250	0-19 ans
Tumeurs cérébrales	3,500	0-19 ans
Lymphome	2,750	0-19 ans

Professionnels de la santé en oncologie

Le premier jour biopharmaceutique cible 8 500 professionnels spécialisés en oncologie en oncologie.

• Oncologues pédiatriques: 2 300
• Infirmières en oncologie: 4 200
• Pharmaciens cliniques: 1 200
• Infirmières praticiennes en oncologie: 800

Institutions de recherche spécialisées dans les cancers de l'enfance

L'entreprise collabore avec 92 institutions de recherche dédiées axées sur les cancers de l'enfance.

Type d'institution	Nombre d'institutions	Budget de recherche annuel
Centres de recherche universitaires	62	378 millions de dollars
Fondations de recherche indépendantes	30	156 millions de dollars

Premier jour Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, les biopharmaceutiques du premier jour ont déclaré des dépenses de R&D de 74,5 millions de dollars, ce qui représente une augmentation de 52% par rapport à 49,0 millions de dollars en 2022.

Exercice fiscal	Dépenses de R&D	Changement d'une année à l'autre
2022	49,0 millions de dollars	-
2023	74,5 millions de dollars	Augmentation de 52%

Coûts de gestion des essais cliniques

Les dépenses des essais cliniques pour les biopharmaceutiques du premier jour en 2023 ont totalisé environ 42,3 millions de dollars, en se concentrant sur les programmes d'oncologie pédiatrique.

• Essais de tumeurs solides pédiatriques: 22,1 millions de dollars
• Essais neurologiques en oncologie: 15,7 millions de dollars
• Coûts administratifs des essais cliniques: 4,5 millions de dollars

Investissements de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 s'élevaient à 8,7 millions de dollars, couvrant les interactions, la documentation et les processus de soumission de la FDA.

Protection de la propriété intellectuelle

Les coûts de propriété intellectuelle en 2023 se sont élevés à 3,2 millions de dollars, notamment les frais de dépôt de brevets, d'entretien et de protection juridique.

Catégorie de coûts IP	Frais
Dépôt de brevet	1,6 million de dollars
Entretien de brevets	1,1 million de dollars
Protection juridique	0,5 million de dollars

Recrutement avancé des talents scientifiques

Les frais d'acquisition et de recrutement de talents pour le personnel scientifique spécialisé en 2023 étaient de 6,5 millions de dollars.

• Recrutement principal du personnel scientifique: 3,8 millions de dollars
• Embauche de chercheur d'entrée de gamme: 1,7 million de dollars
• Marketing et dépistage du recrutement: 1,0 million de dollars

Jour 1 Biopharmaceuticals, Inc. (Dawn) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle de médicament

Au quatrième trimestre 2023, les biopharmaceutiques du premier jour ont déclaré des revenus potentiels de leur drogue principal Hemetem (tovorafenib) pour le gliome pédiatrique de bas grade, avec un potentiel de marché estimé de 250 à 300 millions de dollars par an.

Drogue	Indication	Potentiel des revenus annuels estimés
Hémétém	Gliome pédiatrique de bas grade	250 à 300 millions de dollars

Subventions et financement de recherche

En 2023, les biopharmaceutiques du premier jour ont reçu environ 15,2 millions de dollars de subventions de recherche de diverses sources.

• Grant des National Institutes of Health (NIH): 7,5 millions de dollars
• GRANTION DE LA FOURNISSANCE DE RECHERCHE DE CANCER: 4,2 millions de dollars
• Subvention de recherche en oncologie pédiatrique: 3,5 millions de dollars

Accords de partenariat stratégique

La société a établi des partenariats stratégiques générant des sources de revenus potentiels:

Partenaire	Type d'accord	Revenus potentiels
Novartis	Collaboration de recherche	20 millions de dollars d'avance
Roche	Partenariat de développement de médicaments	15 millions de dollars de paiement jalon

Licence potentielle des technologies thérapeutiques

Le premier jour biopharmaceuticals a des revenus de licence potentiels de leur plate-forme d'inhibiteur de kinase propriétaire, estimée à 50 à 75 millions de dollars en frais de licence potentiels.

Soutien du gouvernement et de la recherche philanthropique

Le soutien total de la recherche en 2023 a atteint 22,8 millions de dollars provenant de diverses sources gouvernementales et philanthropiques.

• Concessions de recherche fédérales: 12,6 millions de dollars
• Support de l'organisation philanthropique: 10,2 millions de dollars

Total des sources de revenus potentiels pour 2024: 350 à 450 millions de dollars estimés

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Value Propositions

You're looking at the core value Day One Biopharmaceuticals, Inc. (DAWN) delivers with OJEMDA (tovorafenib), which is a significant shift for a very vulnerable patient group. The value proposition centers on being the first-in-class, targeted option where few existed before.

First and only targeted therapy for relapsed/refractory pediatric low-grade glioma (pLGG). This is the cornerstone. OJEMDA received Accelerated Approval from the U.S. FDA on April 23, 2024, for patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This made it the first and only FDA-approved type II RAF inhibitor for this indication.

The drug offers an oral, brain-penetrant treatment option for a vulnerable patient population. Tovorafenib is specifically designed as an oral, brain-penetrant, highly-selective type II RAF kinase inhibitor. This is crucial because pLGG is the most common pediatric brain cancer, and for the majority of children whose disease recurs after surgery, systemic therapy is needed.

The clinical benefit demonstrated in the pivotal FIREFLY-1 trial provides tangible value, especially regarding durability. The latest three-year follow-up data from Arm 1 of the FIREFLY-1 trial, with a data cutoff of June 6, 2025, showed compelling results for the 76 evaluable patients.

Here are the key clinical metrics that define this value:

• Overall response rate (ORR) was 53% (40/76).
• Median duration of response (DOR) was 19.4 months (95% CI [13.8-27.2]).
• Median time to next treatment (TTNT) exceeded 3.5 years.
• 58% (44/76) of patients completed 26 or more cycles of treatment (approximately 24 months).
• 77% of patients who entered the treatment-free observation period remained off therapy for a minimum of 12 months.

For clinicians, the value proposition includes a reduced administrative burden, supported by high initial assessment rates indicating broad efficacy. While the initial ORR was 51%, an earlier assessment showed a Clinical Benefit Rate (CBR) of 91%, which captures a wider range of positive patient outcomes beyond just tumor shrinkage, helping streamline treatment decisions for patients not achieving a formal response.

The company's mission reinforces this value by showing a commitment to developing medicines for unmet needs in pediatric cancer. This focus is evident in their commercial performance, which supports continued pipeline investment. For instance, the company raised its full-year 2025 net product revenue guidance to $145 to $150 million as of November 2025, following Q3 2025 net product revenue of $38.5 million.

Here's a quick look at the commercial traction supporting this value proposition as of late 2025:

Metric	Value (as of late 2025)	Reporting Period/Context
OJEMDA Net Product Revenue	$38.5 million	Third Quarter 2025
U.S. OJEMDA Net Product Revenue YTD	$102.6 million	Year-to-Date through Q3 2025
2025 Net Product Revenue Guidance	$145 to $150 million	Full Year 2025 Forecast
Cash, Cash Equivalents, and Investments	$451.6 million	As of September 30, 2025
Estimated pLGG Patients Needing Systemic Therapy	2,000 to 3,000	At any given time in the relapse setting

This combination of being the first-in-class, offering durable responses, and showing strong commercial uptake-with Q3 2025 revenue hitting $38.5 million-is what defines the current value proposition for Day One Biopharmaceuticals, Inc. (DAWN).

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Customer Relationships

You're looking at how Day One Biopharmaceuticals, Inc. connects with the specialized community that prescribes and uses OJEMDA. For a targeted therapy like this, the relationship isn't about mass marketing; it's about deep, specialized engagement with a small group of pediatric oncologists.

High-touch, specialized sales force engagement with pediatric oncologists

The sales force strategy focuses on depth within key accounts, which is where the majority of relapsed/refractory BRAF-altered, pLGG patients are managed. Day One Biopharmaceuticals, Inc. has segmented its customer base to focus resources effectively. As of the first quarter of 2025, the company estimated the patient management load across these segments:

Account Priority Level	Estimated Patients Managed Per Account
Priority One Accounts	230
Priority Two Accounts	60
Priority Three Accounts	40

This structure supports the goal of accelerating adoption and establishing OJEMDA as the second-line standard of care. The commercial momentum reflects this focus, with quarterly total prescriptions (TRx) reaching 1,256 in the third quarter of 2025, an 18% increase from the second quarter of 2025. New patient starts also accelerated, growing 19% quarter-over-quarter in Q3 2025.

Patient support programs like EveryDay Support From Day One

Day One Biopharmaceuticals, Inc. supports the patient journey through dedicated programs. While specific enrollment numbers for the EveryDay Support From Day One program aren't public, the financial data strongly suggests high patient adherence and successful access, which these programs help facilitate. The reliance on paid prescriptions is very low for free drug support.

Direct communication with the pLGG patient and caregiver community

The company actively engages with the community that lives with pediatric low-grade glioma (pLGG). This is evident in the public sharing of patient and caregiver perspectives, such as hearing from Heather, a mom to a pLGG patient, and featuring stories like Bradon's. This direct connection helps ground the commercial and clinical strategy in real-world patient needs.

• Hear from patients living with pediatric low-grade glioma (pLGG) and their caregivers.
• Featuring stories like Bradon's, who has been living with pLGG since age 11.

Building prescriber confidence through consistent clinical data presentations

Sustained confidence among prescribers is built on robust, long-term data. The introduction of clinical updates has directly supported prescription growth. For instance, the presentation of two-year follow-up data from the FIREFLY-1 trial at the 2025 American Society of Clinical Oncology (ASCO) meeting, and the planned oral presentation of three-year FIREFLY-1 data at the Society for Neuro-Oncology on November 23, 2025, serve as key relationship-building milestones with the medical community.

Managed access programs to ensure patients get the drug defintely

Ensuring patients can actually start and stay on therapy is critical. The managed access framework appears highly effective, translating to strong payer coverage. As of the second quarter of 2025, the results showed:

• Over 90% of OJEMDA patients received approval upon initial submission.
• More than 95% of patients on OJEMDA are paid patients.
• Less than 5% of patients are receiving free drugs.

To be fair, the company has also closed the door on one form of access; Tovorafenib is no longer available for expanded access or compassionate use in the United States (U.S.).

The commercial success, with OJEMDA net product revenue reaching $38.5 million in Q3 2025 and the full-year 2025 guidance raised to $145 to $150 million, is a direct reflection of these customer relationship successes.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Channels

You're looking at how Day One Biopharmaceuticals, Inc. gets its product, OJEMDA (tovorafenib), to the pediatric oncologists and patients who need it, while also managing its pipeline and investor base as of late 2025. The channels are a mix of direct commercial efforts and scientific engagement.

Direct sales force targeting key pediatric cancer centers and oncologists. This is the engine for OJEMDA's commercial success. The company reported that quarterly prescriptions (TRx) grew to 1,256 in the third quarter of 2025, an 18% increase compared to the second quarter of 2025. New patient starts accelerated by almost 20% quarter-over-quarter in Q3 2025. Day One Biopharmaceuticals, Inc. had 181 total employees as of October 2025, which supports the field force and overall operations. The commercial execution delivered the best quarter launch-to-date for OJEMDA, leading to raised full-year 2025 net product revenue guidance to $145 to $150 million.

Specialty pharmacy network for drug distribution and patient services. Distribution relies on a strong payer mix to ensure patient access. Over 95% of patients on OJEMDA are paid patients, with less than 5% receiving free drugs. Furthermore, about 90% of patients receive approval upon initial submission, which helps streamline the process from the specialty pharmacy network to the patient.

Medical Science Liaisons (MSLs) for scientific exchange with key opinion leaders. Scientific exchange is critical for building the case for second-line standard-of-care. This channel is supported by data dissemination, such as the three-year follow-up data from the pivotal FIREFLY-1 trial presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting in November 2025. The company's pipeline progress, including advancing DAY301, also fuels MSL discussions.

Investor and media relations for corporate communication and visibility. Day One Biopharmaceuticals, Inc. actively communicates progress through formal channels. The company hosted a webcast to report third quarter 2025 financial results on November 4, 2025. They also participated in the Piper Sandler 37th Annual Healthcare Conference in November 2025. For ongoing communication, Day One uses its Investor Relations website (ir.dayonebio.com), its X handle (x.com/DayOneBio), and its LinkedIn Home Page (linkedin.com/company/dayonebio) to disseminate news.

Clinical trial sites for pipeline development and data generation. These sites are essential for advancing the pipeline beyond the currently approved indication. The company is progressing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial, with enrollment completion anticipated in the first half of 2026. The DAY301 program is also advancing dose escalation in its Phase 1a clinical trial.

Here's a quick look at the commercial scale driving the distribution channels as of the end of Q3 2025:

Metric	Value as of Late 2025 Data Point
Q3 2025 Net Product Revenue (OJEMDA)	$38.5 million
2025 Year-to-Date Net Product Revenue (Through Q3)	$102.6 million
Full-Year 2025 Revenue Guidance (Raised)	$145 to $150 million
Q3 2025 Total Prescriptions (TRx)	1,256
Q3 2025 Sequential TRx Growth	18%
Cash, Cash Equivalents, and Short-Term Investments (As of 9/30/2025)	$451.6 million

The success of the commercial channel is evident in the prescription growth, but the pipeline channel requires continued investment, as reflected by the $451.6 million cash position at the end of Q3 2025, which funds both current sales and future development.

• Payer Coverage: Over 95% paid patients.
• Initial Approval Rate: About 90% on first submission.
• Pipeline Milestone: FIREFLY-2 enrollment completion targeted for first half of 2026.

Finance: review the Q4 2025 cash burn projection against the current $451.6 million reserve by next Tuesday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Customer Segments

You're hiring before product-market fit is fully cemented, so understanding exactly who you are selling to-and who is paying-is the core of the strategy right now. For Day One Biopharmaceuticals, Inc. (DAWN), the customer segments are layered, moving from the end-user patient to the ultimate payer.

Pediatric patients with relapsed/refractory low-grade glioma (pLGG)

This is the core patient population for OJEMDA (tovorafenib), which received FDA accelerated approval in April 2024 for patients 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The market opportunity is defined by the number of patients needing systemic therapy after initial treatments fail.

Here's the quick math on the U.S. patient flow as of late 2025:

Patient Metric	Estimated Number
U.S. Incident Patients <25 years old with CNS Tumors	~5,500
Estimated Rate of Low Grade Gliomas (LGGs)	~77% of CNS Tumors
Estimated Patients Ineligible for Surgery or Post Surgery	~1,100
Estimated % BRAF Fusion/Rearrangement (Target Population)	~80%
Annual U.S. Treated Relapsed/Refractory (r/r) pLGG Population Eligible for Systemic Therapy	~2,000-3,000

What this estimate hides is the dynamic nature of progression; the majority of pLGG patients will progress within 5 years, constantly feeding the relapsed/refractory pool. Day One Biopharmaceuticals is also advancing its pivotal Phase 3 FIREFLY-2 clinical trial for first-line pLGG, which is expected to complete enrollment in the first half of 2026.

Oncologists and hematologists at specialized cancer treatment centers

These are the prescribers who translate clinical data into treatment decisions. Their confidence directly drives prescription volume. The commercial momentum shows they are adopting OJEMDA.

• Total Prescriptions (TRx) in Q3 2025 reached 1,256.
• New patient starts grew 19% in Q3 2025 compared to Q2 2025.
• The drug is now added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.
• The company raised its full-year 2025 net product revenue guidance to $145-$150 million based on this physician confidence.

The introduction of 2-year follow-up data from the FIREFLY-1 trial at the Society for Neuro-Oncology conference in November 2025 was a key event for strengthening prescriber conviction.

Global regulatory bodies (e.g., FDA, EMA) and health technology assessment groups

These bodies control market access and the standard of care evolution. The FDA has already provided a major tailwind with accelerated approval in April 2024 and Breakthrough Therapy designation.

• FDA granted OJEMDA Breakthrough Therapy and Rare Pediatric Disease designations.
• The European Medicines Agency (EMA) accepted the regulatory filing for tovorafenib for review in April 2025.
• An EMA regulatory decision is expected in 2026.

Health technology assessment (HTA) groups, which determine value for reimbursement, are influenced by the growing clinical evidence, including the 3-year follow-up data expected in late 2025.

Payers and third-party reimbursement organizations

Payer acceptance is critical for commercial success, especially in the US where patient out-of-pocket costs can be a barrier. Day One Biopharmaceuticals has achieved strong initial access metrics.

As of Q2 2025 reporting:

Payer Metric	Percentage
Patients Receiving Approval on Initial Submission	Over 90%
Paid Patients on OJEMDA	More than 95%
Patients Receiving Free Drug	Less than 5%

This high rate of paid prescriptions suggests favorable coverage terms are largely in place, though the company noted in Q1 2025 that they still manage seasonality related to payer dynamics and deductible resetting.

Caregivers and patient advocacy groups in the pediatric oncology space

While not direct purchasers, these groups influence physician choice and payer dialogue. Day One Biopharmaceuticals was founded, in part, by being inspired by the 'Day One Talk' physicians have with families about diagnosis and treatment plans. The company partners with leading clinical oncologists, families, and scientists. The focus on targeted therapy for a rare pediatric cancer addresses a critical unmet need that resonates strongly with advocacy organizations dedicated to improving outcomes for children with life-threatening diseases.

Finance: draft 13-week cash view by Friday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Cost Structure

You're looking at the cost side of Day One Biopharmaceuticals, Inc. (DAWN) as they scale up OJEMDA and push pipeline assets. The cost structure is heavily weighted toward getting the drug to market and advancing clinical programs. Honestly, for a commercial-stage biotech, this is where the cash burn is most visible.

Research and Development (R&D) remains a major cost driver, funding the future pipeline alongside the current commercial product. For the third quarter of 2025, R&D expenses totaled $31.4 million. This covers the ongoing work for key programs like the pivotal Phase 3 FIREFLY-2 trial for first-line pediatric low-grade glioma (pLGG) and the advancement of the DAY301 antibody drug conjugate (ADC) through dose escalation in its Phase 1a trial.

Selling, General, and Administrative (SG&A) costs reflect the investment in the OJEMDA launch. In Q3 2025, SG&A expenses were $28.1 million. This line item absorbs the commercialization and marketing costs associated with building physician confidence and driving adoption for OJEMDA. To be fair, the company noted that in Q3 2024, the increase in SG&A was primarily due to employee compensation costs and commercial launch activities.

The cost of revenue is relatively small compared to operating expenses, especially since a large portion of revenue comes from a license agreement that has now largely recognized its upfront payment. For instance, in Q3 2025, License Revenue was only $1.3 million. The cost of product revenue is a more direct operational expense. For example, in Q1 2025, the Cost of product revenue was $2.9 million.

Here's a quick look at how the major operating expenses trended across the first three quarters of 2025, showing the scale of investment:

Expense Category	Q1 2025 Amount	Q3 2025 Amount
Research and Development (R&D) Expenses	$39.6 million	$31.4 million
Selling, General, and Administrative (SG&A) Expenses	$29.3 million	$28.1 million
License Revenue	$0.3 million	$1.3 million

The company's overall financial discipline is evident in its cash position, which stood at $451.6 million as of September 30, 2025, providing a substantial runway to fund these costs without immediate external financing pressure.

You can see the key cost components that Day One Biopharmaceuticals, Inc. (DAWN) is managing:

• R&D spending supporting pipeline progression.
• SG&A covering the OJEMDA commercial infrastructure.
• Clinical trial costs for FIREFLY-2 and DAY301 embedded in R&D.
• Marketing and sales efforts for OJEMDA within SG&A.

Finance: draft 13-week cash view by Friday.

Day One Biopharmaceuticals, Inc. (DAWN) - Canvas Business Model: Revenue Streams

You're looking at the current revenue generation for Day One Biopharmaceuticals, Inc. as of late 2025. It's a mix of product sales, which are ramping up nicely, and the tail end of a significant upfront payment from a prior licensing deal. Honestly, the focus now is on driving that product revenue higher.

The primary driver for Day One Biopharmaceuticals, Inc. revenue streams is the commercial success of its lead product, OJEMDA. The company has been gaining traction with prescribers, which is reflected in their updated financial outlook.

• U.S. net product revenue from OJEMDA sales is guided to be between $145 million and $150 million for the full-year 2025.
• Year-to-date through the third quarter of 2025, U.S. OJEMDA net product revenue reached $102.6 million.
• The third quarter of 2025 alone saw net product revenue of $38.5 million, a 15% increase from the second quarter of 2025.

License revenue, which was a large component in the prior year due to an upfront payment, is now much smaller as that initial recognition is complete. For instance, license revenue from the sale of ex-U.S. commercial rights for tovorafenib was only $1.3 million in the third quarter of 2025. To be fair, this compares to a much larger $73.7 million recognized in the third quarter of 2024, which included the upfront consideration of $73.5 million received from Ipsen for the pLGG license rights.

The partnership agreements are structured to provide significant future, non-guaranteed revenue through milestones and royalties. These represent potential upside that analysts definitely watch closely.

Partnership/Deal	Upfront/Near-Term Consideration (Approximate)	Total Potential Milestone Payments	Royalty Structure
Ipsen (ex-U.S. Tovorafenib)	Approximately $111 million (cash and equity investment)	Up to approximately $350 million	Tiered double-digit royalties starting at mid-teens percentage
MabCare Therapeutics (DAY301/MTX-13)	$55 million (Upfront Payment)	Up to $1.152 billion	Low-to-mid single-digit percentage royalties on net sales outside Greater China

Looking ahead, future product revenue hinges on the success of pipeline assets like DAY301, the Company's PTK7-targeted Antibody-Drug Conjugate (ADC). The IND application for DAY301 was cleared by the FDA in April 2024, and the Phase 1a trial is actively enrolling patients, with first patient dosing having been expected in late 2024 or early 2025. If approved, DAY301 could open up an entirely new revenue stream targeting multiple adult and pediatric solid tumors.

You should keep an eye on the progression of DAY301, as achieving development or regulatory milestones on that asset could trigger those large, contingent payments outlined in the MabCare agreement. Finance: draft 13-week cash view by Friday.