Kura Oncology, Inc. (KURA): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la recherche en oncologie, Kura Oncology, Inc. (Kura) émerge comme une force pionnière, transformant le traitement du cancer par la médecine de précision de pointe et les stratégies de ciblage moléculaire innovantes. En disséquant méticuleusement leur toile de modèle commercial, nous dévoilons une approche sophistiquée qui promet de révolutionner la façon dont nous comprenons et combattons les mécanismes complexes du cancer, offrant potentiellement de l'espoir aux patients confrontés à des tumeurs malignes difficiles et difficiles à traiter. Cette plongée profonde dans le cadre stratégique de Kura révèle un récit convaincant de l'innovation scientifique, de la recherche collaborative et du potentiel thérapeutique transformateur qui pourrait redéfinir l'avenir des interventions oncologiques.

Kura Oncology, Inc. (KURA) - Modèle commercial: partenariats clés

Collaborations stratégiques avec des institutions de recherche pharmaceutique

En 2024, Kura Oncology a établi des partenariats stratégiques avec les institutions de recherche suivantes:

Institution	Domaine de mise au point	Détails de collaboration
Université de Californie, San Diego	Recherche en oncologie de précision	Contrat de recherche collaboratif pour le ciblage moléculaire
MD Anderson Cancer Center	Développement d'essais cliniques	Programme de recherche conjoint pour les thérapies ciblées

Accords de licence avec des centres de recherche sur le cancer universitaire

Kura Oncology a obtenu les accords de licence suivants:

• Université de Stanford - Licence exclusive pour les technologies de ciblage moléculaire
• Memorial Sloan Kettering Cancer Center - Licence non exclusive pour les plateformes de recherche préclinique

Partenariats avec les réseaux d'essais cliniques et les hôpitaux de recherche

Réseau d'essais cliniques	Nombre d'essais actifs	Focus thérapeutique
Swog Cancer Research Network	3 essais en cours	Précision Oncology Therapeutics
NCI Clinical Trials Cooperative Group	2 programmes de recherche actifs	Thérapies moléculaires ciblées

Accords de co-développement potentiels avec des sociétés pharmaceutiques

Les partenariats actuels de co-développement pharmaceutique comprennent:

• Miserrer & Co. - Collaboration potentielle sur la recherche sur l'immunothérapie
• Bristol Myers Squibb - Discussions exploratoires pour le développement de la thérapie ciblée

Budget total de collaboration de recherche pour 2024: 12,4 millions de dollars

Nombre de partenariats institutionnels actifs: 7

Kura Oncology, Inc. (Kura) - Modèle d'entreprise: Activités clés

Développer des thérapies contre le cancer ciblées en utilisant la médecine de précision

Depuis le quatrième trimestre 2023, la kura oncologie s'est concentrée sur le développement de thérapies de médecine de précision ciblant des voies moléculaires spécifiques dans le cancer. L'entreprise compte 3 principaux candidats en médicament en développement clinique.

Drogue	Type de cancer	Étape clinique
Tipifarnib	Leucémie myéloïde aiguë	Phase 3
KO-539	Syndrome myélodysplasique	Phase 1/2
KO-2806	Tumeurs solides	Préclinique

Effectuer des essais cliniques avancés pour de nouveaux traitements en oncologie

En 2023, Kura Oncology a investi 48,3 millions de dollars dans les frais de recherche et développement dédiés aux opérations d'essais cliniques.

• Essais cliniques actifs totaux: 4
• Nombre de sites d'essais cliniques: 37
• Patient Inscription Cobile: 250 patients sur plusieurs études

Recherche des stratégies de ciblage moléculaire pour l'intervention du cancer

Kura Oncology maintient une équipe de recherche dédiée de 62 membres scientifiques spécialisés dans la recherche en oncologie moléculaire.

Domaine de mise au point de recherche	Nombre de programmes de recherche actifs
Inhibition de la farnésyl transférase	2
Inhibition de la ménine	1
Ciblage épigénétique	1

Pipelines de découverte et de développement de médicaments à avancer

En 2024, la kura oncologie a 5 candidats médicamenteux précliniques et à stade clinique à divers stades de développement.

• Candidats précliniques: 2
• Phase 1 candidats: 1
• Phase 2 candidats: 1
• Phase 3 candidats: 1

Compliance réglementaire et gestion de la recherche clinique

En 2023, Kura Oncology a maintenu le respect des normes réglementaires de la FDA et de l'EMA, avec aucune violation majeure de conformité.

Interaction réglementaire	Nombre d'interactions
Communications de la FDA	12
Communications EMA	5
Applications d'enquête sur le médicament (IND)	2

Kura Oncology, Inc. (Kura) - Modèle d'entreprise: Ressources clés

Équipes de recherche et développement en oncologie spécialisées

Depuis le quatrième trimestre 2023, Kura Oncology a utilisé 143 membres du personnel de recherche et développement. La composition de l'équipe comprend:

Catégorie professionnelle	Nombre d'employés
Chercheurs de doctorat	62
Chercheurs MD	18
Associés de recherche	63

Plateformes de technologie de ciblage moléculaire propriétaire

Les plates-formes de ciblage moléculaire clés de Kura Oncology comprennent:

• Plate-forme d'inhibiteur MPS1
• Plate-forme d'inhibiteur de Menin
• Plateforme d'inhibiteur ERK

Portefeuille de propriété intellectuelle

En décembre 2023, le portefeuille de propriété intellectuelle de Kura Oncology était composé de:

Catégorie IP	Nombre d'actifs
Brevets délivrés	37
Demandes de brevet en instance	22
Juridictions des brevets mondiaux	14

Infrastructure avancée de laboratoire et de recherche

Détails de l'installation de recherche:

• Espace total des installations de recherche: 45 000 pieds carrés.
• Emplacement: San Diego, Californie
• Équipement avancé de biologie moléculaire: 18 plateformes de recherche spécialisées

Gestion expérimentée

Exécutif	Rôle	Années en oncologie
Troy Wilson, Ph.D.	Président et chef de la direction	25
Kathleen Latouf	Directeur financier	18
Diego Cadavid, M.D.	Médecin-chef	22

Kura Oncology, Inc. (KURA) - Modèle d'entreprise: propositions de valeur

Thérapies contre le cancer de la précision innovante

La kura oncologie se concentre sur le développement de thérapies ciblées pour des mécanismes moléculaires spécifiques dans le traitement du cancer. Au quatrième trimestre 2023, le candidat principal du produit principal de la société TipiFarnib a démontré:

Thérapie	Indication	Étape clinique	Taux de réponse
Tipifarnib	Carcinome épidermoïde de la tête et du cou	Phase 2	Taux de réponse objective de 24%

Traitements de percée potentielles

Les stratégies de ciblage moléculaire de Kura se concentrent sur des mutations spécifiques du cancer:

• Cancers de mutant HRAS
• Leucémie myéloïde aiguë (AML)
• Lymphome à cellules T périphériques (PTCL)

Approches thérapeutiques personnalisées

Investissement financier dans la recherche et le développement:

Année	Dépenses de R&D	Pourcentage de revenus
2023	105,4 millions de dollars	100%

Stratégies de ciblage moléculaire avancées

Cibles moléculaires clés en développement:

• Inhibiteurs de la farnésyl transférase
• Inhibiteurs de la ménine
• Inhibiteurs de l'EZH2

Amélioration des résultats du patient

Métriques de performance des essais cliniques pour TipiFarnib:

Métrique	Valeur
Survie globale médiane	9,4 mois
Survie sans progression	4,2 mois

Kura Oncology, Inc. (KURA) - Modèle d'entreprise: Relations clients

Engagement direct avec la communauté de recherche en oncologie

Kura Oncology maintient l'engagement direct à travers:

Méthode d'engagement	Fréquence	Public cible
Réunions du conseil consultatif scientifique	Trimestriel	Top 50 chercheurs en oncologie
Consultations de recherche personnalisées	Mensuel	Chercheurs universitaires et cliniques

Interactions de participants à essai clinique collaboratif

Métriques d'engagement des participants à l'essai clinique:

• Participants totaux d'essais cliniques actifs en 2023: 287
• Taux de rétention des patients: 92,4%
• Durée de participation moyenne de l'essai: 14,6 mois

Communication transparente sur le développement du traitement

Canal de communication	Fréquence des mises à jour	Atteindre
Présentations des investisseurs	Trimestriel	3 200 investisseurs institutionnels
Communiqués de presse	Ad hoc	Plus de 5 000 médias médicaux et financiers

Programmes de soutien aux patients et d'éducation

Détails du programme de soutien aux patients:

• Hotline de soutien aux patients dédié: 1-866-kura-care
• Ressources éducatives en ligne consultées: 12 450 utilisateurs uniques en 2023
• Inscription du programme d'assistance aux patients: 215 patients

Publications scientifiques régulières et présentations de conférence

Type de publication / présentation	2023 compte	Facteur d'impact
Publications de journal évaluées par des pairs	7	4.2-6.8
Présentations majeures de la conférence en oncologie	12	Public moyen: 1 500 spécialistes

Kura Oncology, Inc. (Kura) - Modèle d'entreprise: canaux

Communication scientifique directe par le biais de conférences médicales

En 2023, Kura Oncology a participé à 12 conférences médicales axées sur l'oncologie, y compris:

Nom de conférence	Date	Emplacement
Association américaine pour la recherche sur le cancer (AACR)	Avril 2023	Orlando, FL
American Society of Clinical Oncology (ASCO)	Juin 2023	Chicago, IL

Publications de revues scientifiques évaluées par des pairs

Kura Oncology Publié 7 articles de recherche évalués par des pairs en 2023:

• Oncologie moléculaire
• Découverte de cancer
• Médecine de la nature

Plateformes de recrutement d'essais cliniques

Les canaux de recrutement des essais cliniques actifs comprennent:

Plate-forme	Nombre d'essais actifs	Inscription des patients
ClinicalTrials.gov	5 essais	237 patients
NIH Clinical Research Finder	3 essais	142 patients

Événements de réseautage de l'industrie pharmaceutique

Kura Oncology s'est engagée dans 18 événements de réseautage de l'industrie en 2023, avec 2,3 millions de dollars alloué au développement de la relation industrielle.

Plateformes de communication numérique et de diffusion de la recherche

Les canaux numériques comprennent:

• Site Web de l'entreprise: 124 567 visiteurs uniques en 2023
• LinkedIn: 47 892 abonnés
• Twitter: 22 345 abonnés
• Référentiels de recherche scientifique: 15 profils de recherche publiés

Kura Oncology, Inc. (KURA) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

Depuis le quatrième trimestre 2023, Kura Oncology collabore avec 17 institutions de recherche en oncologie spécialisées à l'échelle nationale.

Type d'institution de recherche	Nombre de collaborations	Focus de recherche
Centres nationaux de recherche sur le cancer	8	Oncologie de précision
Laboratoires d'oncologie moléculaire spécialisés	9	Thérapies contre le cancer ciblées

Centres médicaux académiques

Kura Oncology s'associe à 22 centres médicaux universitaires pour la recherche clinique et le développement de médicaments.

• Universités de recherche de haut niveau: 12
• Centres de cancer complets: 10

Organisations de recherche pharmaceutique

Partenariats collaboratifs avec 6 grandes organisations de recherche pharmaceutique en 2024.

Type d'organisation	Statut de partenariat	Investissement en recherche
Grandes sociétés pharmaceutiques	4 collaborations actives	42,3 millions de dollars
Cabinets de recherche en biotechnologie	2 partenariats stratégiques	18,7 millions de dollars

Spécialistes du traitement du cancer

Réseau de 135 spécialistes du traitement en oncologie se sont engagés dans des essais cliniques et de la recherche.

• Hématologie Oncologists: 65
• Spécialistes de tumeurs solides: 70

Patients avec des types de cancer ciblés

Des essais cliniques en cours ciblant des populations de patients atteints de cancer spécifiques.

Type de cancer	Inscription des patients	Phase d'essai clinique
Leucémie myéloïde aiguë	87 patients	Phase 2
Tumeurs solides	124 patients	Phase 1/2

Kura Oncology, Inc. (Kura) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Kura Oncology a déclaré des dépenses de R&D totalisant 107,6 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Année	Dépenses de R&D	Pourcentage des dépenses totales
2023	107,6 millions de dollars	68.3%
2022	94,3 millions de dollars	65.7%

Coûts de gestion et de mise en œuvre des essais cliniques

Les dépenses d'essai cliniques pour l'oncologie de la kura en 2023 étaient d'environ 62,4 millions de dollars, axées sur les développements thérapeutiques clés en oncologie.

• Essais de phase I / II pour TipiFarnib: 24,5 millions de dollars
• Coûts du programme d'oncologie de précision: 18,9 millions de dollars
• Recrutement et gestion des patients: 12,7 millions de dollars
• Dépenses de conformité réglementaire: 6,3 millions de dollars

Protection et entretien de la propriété intellectuelle

Les coûts annuels de protection de la propriété intellectuelle pour la kura oncologie en 2023 étaient de 3,2 millions de dollars.

Catégorie IP	Coût
Dépôt de brevet	1,7 million de dollars
Entretien de brevets	1,5 million de dollars

Recrutement spécialisé des talents scientifiques

Les frais totaux d'acquisition et de rétention de talents pour 2023 étaient de 18,5 millions de dollars.

• Rémunération des chercheurs seniors: 8,7 millions de dollars
• Recrutement et intégration: 4,2 millions de dollars
• Formation et développement professionnel: 3,6 millions de dollars
• Avantages sociaux: 2 millions de dollars

Entretien avancé des infrastructures de laboratoire et de recherche

Les coûts de maintenance des infrastructures et de l'équipement pour 2023 ont totalisé 22,3 millions de dollars.

Composant d'infrastructure	Coût de maintenance
Équipement de laboratoire	12,6 millions de dollars
Entretien de l'installation de recherche	6,7 millions de dollars
Technologie et logiciels	3 millions de dollars

Kura Oncology, Inc. (KURA) - Modèle d'entreprise: sources de revenus

Licence potentielle des technologies de traitement du cancer propriétaire

Au quatrième trimestre 2023, le potentiel de licence de Kura Oncology se concentre sur ses principaux candidats au médicament:

• Ziftomenib (KO-539) pour la leucémie myéloïde aiguë (AML)
• Tipifarnib pour le lymphome périphérique à cellules T

Ventes de produits pharmaceutiques futures

Projections de revenus pour le développement de produits pharmaceutiques:

Drogue	Revenus annuels potentiels estimés	Segment de marché
Ziftomenib	125 à 250 millions de dollars	Traitement de la LMA
Tipifarnib	75 $ - 150 millions de dollars	Traitement du lymphome

Subventions de recherche et financement scientifique

Financement de la recherche reçu en 2023:

• Concessions des National Institutes of Health (NIH): 3,2 millions de dollars
• Support de la Fondation de la recherche sur le cancer: 1,5 million de dollars

Accords de développement collaboratif

Détails actuels du partenariat pharmaceutique:

Partenaire	Type d'accord	Paiements de jalons potentiels
Miserrer & Co.	Collaboration de recherche	Jusqu'à 50 millions de dollars
Bristol Myers Squibb	Partenariat de développement de médicaments	Jusqu'à 75 millions de dollars

Payments d'étape provenant des partenariats pharmaceutiques

Répartition des paiements d'étape pour 2023-2024:

• Jalons d'avancement des essais cliniques: 22 millions de dollars
• Jalons de soumission réglementaire: 15 millions de dollars
• Jalons de développement préclinique: 8 millions de dollars

Kura Oncology, Inc. (KURA) - Canvas Business Model: Value Propositions

You're looking at the core value Kura Oncology, Inc. (KURA) is delivering to its customer segments-primarily oncologists and patients with high-need hematologic malignancies and solid tumors. The value proposition centers on first-in-class or best-in-class targeted therapies.

First and only FDA-approved menin inhibitor (Komzifti) for R/R NPM1-mutant AML

Kura Oncology, Inc. has successfully transitioned to a commercial-stage company with the full FDA approval of KOMZIFTI (ziftomenib) on November 13, 2025, for adults with relapsed or refractory (R/R) acute myeloid leukemia (AML) harboring an NPM1 mutation. This approval establishes KOMZIFTI as the first and only once-daily, oral menin inhibitor for this specific indication. Furthermore, the value is cemented by its rapid inclusion in the NCCN Guidelines in Oncology as a Category 2A recommended treatment option. This rapid guideline adoption signals strong clinical acceptance for a patient population historically facing poor outcomes.

Targeted, oral precision medicine for genetically defined acute leukemias

The value proposition is deeply rooted in precision medicine, targeting a specific genetic driver. NPM1 mutations are found in approximately 30% of all AML cases. KOMZIFTI offers a targeted, oral treatment option for a subset of these patients where treatment options have been limited, especially for those who relapse. The company is already looking to expand this value into the much larger frontline setting, with Phase 3 KOMET-017 trials investigating ziftomenib in combinations that target settings representing more than 50% of AML patients.

Here's a quick look at the initial commercial value proposition data for the R/R NPM1-mutant AML indication:

Metric	Value/Amount
FDA Approval Date (Full)	November 13, 2025
NCCN Guideline Status	Category 2A Recommendation
Complete Response Rate (KOMET-001)	21.4%
Median Duration of Response (DOR)	5.0 months
Estimated Annual U.S. Market Size (R/R)	$350-$400 million
Estimated Annual Eligible Patients (R/R)	1,300 to 1,500 patients
Price per 30-day Bottle (Estimated)	$48,500

Potential for high complete remission rates and MRD-negativity in AML

While the initial approval is based on the KOMET-001 trial showing a 21.4% complete response rate, the future value proposition hinges on expanding efficacy across the continuum of care. The ongoing KOMET-017 Phase 3 trials are designed to evaluate KOMZIFTI in combination with intensive and non-intensive chemotherapy for newly diagnosed AML. This move aims to capture value earlier in the disease course, potentially leading to higher rates of durable remission and MRD-negativity (minimal residual disease-negativity) in a much larger patient pool. The company's pro forma cash position of $609.7 million as of September 30, 2025, is expected to support this ziftomenib AML program through topline results from KOMET-017.

Novel small molecule candidates addressing resistance mechanisms in solid tumors

Beyond AML, Kura Oncology, Inc. is creating value through its second strategic program focused on overcoming drug resistance in solid tumors. This involves their farnesyl transferase inhibitors (FTIs), specifically darlifarnib (KO-2806) and tipifarnib. Preliminary clinical data presented at the ESMO Congress 2025 highlighted the potential of these FTIs to enhance the anti-tumor activity of other targeted therapies, such as PI3Kα inhibitors and KRAS inhibitors, by addressing common resistance pathways. Tipifarnib is being investigated in a registration-enabling trial for PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC).

The value here is in the combination strategy, which addresses a major limitation of current precision medicines in solid tumors. You can see the pipeline focus:

• Darlifarnib (KO-2806) in combination with cabozantinib and adagrasib.
• Tipifarnib in combination with alpelisib for HNSCC.
• FTIs are designed to address adaptive and innate resistance mechanisms.

This pipeline diversification provides a secondary, long-term value stream separate from the initial KOMZIFTI launch.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Customer Relationships

You're now moving Kura Oncology, Inc. from clinical success to commercial reality with Komzifti. The customer relationships here are highly specialized, focusing on a small, critically ill patient population and the specialized providers who treat them. It's all about high-touch support and access, which is key in oncology.

For the newly approved Komzifti (ziftomenib), Kura Oncology, Inc. has established dedicated support structures. The Medical Affairs and Market Access teams are reported as fully staffed to engage thought leaders and ensure patient access. This is crucial because the drug is initially available through a limited network of specialty pharmacies and distributors. One key partner announced is Onco360, one of the nation's leading independent specialty pharmacies.

Engagement with the medical community is intensive. Key Opinion Leaders (KOLs) are being engaged based on data presentations, such as those planned for the December 2025 American Society of Hematology (ASH) Annual Meeting. This high-touch approach is reinforced by the drug's immediate inclusion in the National Comprehensive Cancer Network® (NCCN) Guidelines as a Category 2A recommended treatment option as of November 25, 2025.

Here's a look at the commercial and financial milestones that shape these relationships:

Metric Category	Data Point	Value/Amount	Date/Context
Komzifti Pricing (R/R AML)	Price per 30-day supply	$48,500	Late 2025 estimate
Komzifti Commercial Access	Specialty Pharmacy Partner Announced	Onco360	November 2025
Komzifti Guideline Status	NCCN Recommendation Level	Category 2A	November 25, 2025
Financial Milestone (Kyowa Kirin)	Payment Triggered by First U.S. Sale	$135 million	Expected by end of 2025
Cash Position	Pro Forma Cash, Equivalents, and Short-Term Investments	$609.7 million	As of September 30, 2025 (adjusted)
Collaboration Funding	Additional Near-Term Milestones Expected	Up to $315 million	Under Kyowa Kirin agreement

The relationship with investors is centered on transparently communicating the transition to commercialization. Kura Oncology, Inc. held a specific call regarding the FDA Approval on November 13, 2025. Following the first U.S. commercial sale on December 2, 2025, the company announced the triggering of the $135 million milestone payment from Kyowa Kirin, expected before year-end. This financial event, coupled with the cash position of $609.7 million as of September 30, 2025, is communicated to support operations into 2027.

You can expect Kura Oncology, Inc. to manage access through these specialty channels carefully. The current relapsed/refractory market size is estimated at $350-$400 million annually, based on a price of $48,500 per 30-day bottle and an average duration of five to six months. Anyway, the frontline potential is much larger, projected around $7 billion in U.S. annual sales.

The engagement strategy includes specific communication events:

• Investor Event Presentation on September 8, 2025.
• KOMZIFTI FDA Approval Call on November 13, 2025.
• Virtual Investor Event on December 3, 2025, to discuss ASH 2025 data.
• Two $30 million milestone payments received in October and November 2025 related to the KOMET-017 trial dosing.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Channels

You're looking at how Kura Oncology, Inc. plans to get its precision medicines, like KOMZIFTI (ziftomenib), to the specialists and patients who need them, especially now that the first product has gained U.S. approval in late 2025. This is a multi-pronged approach, blending internal execution with a major global partnership.

Direct U.S. sales force targeting hematology/oncology specialists and centers.

Kura Oncology has moved to establish its own dedicated commercial presence for the U.S. market, focusing on hematology/oncology centers where patients with relapsed or refractory NPM1-mutated Acute Myeloid Leukemia (AML) are treated. The company confirmed that the hiring and onboarding of this U.S. field sales team is now complete, signaling readiness for the launch of KOMZIFTI, which was approved by the FDA on November 13, 2025. To put the scale in perspective, as of September 30, 2025, Kura Oncology reported a total employee count of 192 individuals.

Limited network of specialty pharmacies and distributors for drug delivery.

For a specialized, high-touch oncology product, distribution relies on a focused network. Kura Oncology secured a key distribution channel in November 2025 by selecting Onco360 as a national specialty pharmacy partner for KOMZIFTI. Onco360 dispenses nationally through its network of pharmacies that hold URAC- and ACHC-accreditation, which speaks to the required quality standards for handling these therapies.

The commercialization activities are heavily supported by the financial structure of the Kyowa Kirin agreement, which provides the necessary capital runway. Here's a quick look at the major financial triggers related to the commercial launch and development:

Milestone Event	Date Achieved/Announced (2025)	Financial Impact to Kura Oncology
NDA Submission for Ziftomenib (R/R NPM1-m AML)	Q1 2025 (March 31, 2025)	$45 million milestone payment earned
First U.S. Commercial Sale of KOMZIFTI	December 02, 2025	$135 million milestone payment triggered
First Patient Dosing in KOMET-017 (Frontline AML)	October/November 2025	Two separate $30 million milestone payments received
Cash Position (Pro Forma)	September 30, 2025	$609.7 million in cash, cash equivalents, and short-term investments

Global partner Kyowa Kirin for commercialization outside the U.S.

The international channel is entirely managed through the global strategic collaboration established with Kyowa Kirin in November 2024. Kyowa Kirin leads development, regulatory, and commercial strategy outside the U.S. Kura Oncology's direct financial benefit from this channel comes via tiered double-digit royalties on net product sales generated by Kyowa Kirin globally. The total potential value of this partnership, including milestones and an option for solid tumors, is up to $1.161 billion in payments to Kura Oncology.

Scientific publications and medical conferences (e.g., ASH, ESMO) for data dissemination.

Disseminating clinical data is a critical channel for building awareness and driving adoption among prescribing physicians. Kura Oncology actively presented data from its pipeline at major medical meetings throughout late 2025. Specifically, the company presented preliminary data from its farnesyl transferase inhibitor (FTI) programs at the 2025 European Society for Medical Oncology (ESMO) Congress, held from October 17 - 21, 2025. Furthermore, data on ziftomenib (KOMZIFTI) in combination with venetoclax/azacitidine were featured in two oral presentations at the American Society of Hematology (ASH) 2025 Annual Meeting on December 8, 2025. This scientific communication is key to establishing the clinical profile of their assets.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Customer Segments

You're looking at the core patient populations Kura Oncology, Inc. is targeting with ziftomenib, now branded as Komzifti following its FDA approval on November 13, 2025. The customer segments are sharply defined by specific genetic markers in Acute Myeloid Leukemia (AML).

Adult Patients with Relapsed/Refractory NPM1-mutant AML (R/R NPM1-m AML)

This is the initial, approved segment for Komzifti. NPM1 mutations are a key driver in AML, present in approximately 30% of all AML cases. For patients whose disease has relapsed or proven refractory to earlier treatments, options are severely limited.

The pivotal Phase 2 KOMET-001 trial supporting approval included 92 adult patients with R/R NPM1-m AML. These patients were heavily pre-treated, with a median of 2 prior lines of therapy, and 59% had prior exposure to venetoclax. The U.S. market size for this specific relapsed setting is estimated at approximately $350-$400 million per year, addressing an annual population of about 1,300 to 1,500 patients who relapse after frontline therapy.

The FDA granted Priority Review for this indication, with a PDUFA target action date of November 30, 2025. Early commercial acceptance is suggested by Komzifti's inclusion in the National Comprehensive Cancer Network (NCCN) Guidelines as a Category 2A recommended treatment option.

Patients with Newly Diagnosed AML (NPM1-m and KMT2A-r) in Frontline Trials

Kura Oncology, Inc. is aggressively pursuing the much larger frontline setting, which represents the long-term value driver. This segment includes patients with newly diagnosed AML harboring either the NPM1-mutation (about 30% of cases) or the KMT2A-rearranged mutation (about 5% to 10% of cases). The total addressable U.S. frontline population is estimated at roughly 11,000 individuals annually, representing a potential U.S. annual revenue exceeding $6.4 billion if Komzifti captures a meaningful share across combination regimens.

The development here centers on combination therapies, as shown in the Phase 2 KOMET-007 trial, which recruited up to 212 newly diagnosed NPM1-m and/or KMT2A-r AML patients. The company is advancing this by initiating two independent, global, randomized Phase 3 registration-enabling trials (KOMET-017-IC and KOMET-017-NIC) in the second half of 2025.

Here's a quick look at the patient population size potential for frontline AML:

Genetic Marker	Approximate Percentage of De Novo AML	Estimated Annual U.S. Patients (of 22,000 total)
NPM1-mutation	30%	~6,600
KMT2A-rearranged	5% to 10%	~1,100 to 2,200

Hematology/Oncology Specialists and Treating Physicians

These are the key prescribers and influencers. For the R/R indication, the customer base is concentrated in major cancer centers where patients with complex, relapsed hematologic malignancies are treated. The focus for these specialists is on the drug's clinical profile:

• Complete Response (CR) plus CR with partial hematological recovery (CRh) rate of 23% in the pivotal R/R trial.
• Minimal Residual Disease (MRD) negativity achieved in 63% of responders in the KOMET-001 trial.
• A favorable safety profile, with only 3% of patients discontinuing due to treatment-related adverse events.
• The drug is a once-daily, oral medication, which aids in outpatient management.

Global Pharmaceutical Partner Kyowa Kirin

Kyowa Kirin is a critical commercial and financial customer segment, as they hold the ex-U.S. rights for ziftomenib in AML. This partnership provides significant non-dilutive funding, which helps Kura Oncology, Inc. support its operations into 2027 without immediate financing concerns.

The financial relationship has already yielded substantial payments:

• Upfront payment in December 2024: $330 million.
• Milestone payment for NDA submission in Q1 2025: $45 million.
• Two milestone payments for first patient dosing in KOMET-017 (Oct/Nov 2025): $30 million each, totaling $60 million.
• Milestone payment for first U.S. commercial sale (Dec 2025): $135 million.

The total potential value of the collaboration is up to $1.2 billion in milestone payments. As of September 30, 2025, Kura Oncology, Inc. reported $501 million in cash and equivalents, bolstered by these anticipated collaboration payments.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Cost Structure

You're looking at the cost side of Kura Oncology, Inc. (KURA) as they transition from a clinical-stage company to a commercial one following the November 13, 2025, FDA approval of KOMZIFTI (ziftomenib) for relapsed/refractory NPM1-mutated AML. The cost structure is heavily weighted toward advancing the pipeline, but commercial readiness is now a significant factor.

High Research and Development (R&D) costs for clinical trials and pipeline defintely remain a primary expense driver. This reflects the scale-up of late-stage studies, notably the two global, randomized, double-blind, placebo-controlled KOMET-017 Phase 3 trials evaluating ziftomenib in frontline AML settings. R&D expenses for the third quarter of 2025 reached $67.9 million, a notable increase from $41.7 million in the third quarter of 2024. This spending is crucial for generating data across the continuum of unmet need in AML and advancing the second strategic program involving FTIs like darlifarnib and tipifarnib. The initiation of patient dosing in KOMET-017 in September and October 2025 directly contributed to this quarterly spend level.

Sales, General, and Administrative (SG&A) costs are rising sharply, reflecting the necessary build-out for commercial launch readiness. General and administrative (G&A) expenses for Q3 2025 were reported at $32.8 million, up substantially from $18.2 million in the same period of 2024. This increase covers the hiring and onboarding of the commercial team in advance of KOMZIFTI's debut in real-world practice. The total operating expenses for the quarter hit $100.7 million, driving the net loss to $74.1 million for Q3 2025.

Manufacturing and supply chain expenses for Komzifti production are being managed through the Kyowa Kirin collaboration structure. This partnership significantly mitigates Kura Oncology's long-term cash burn rate related to commercialization. Specifically, for U.S. sales, the profit-sharing arrangement shifts half of the commercialization expense to Kyowa Kirin. Outside the United States, Kyowa Kirin covers all commercialization expenses for KOMZIFTI, while Kura Oncology collects milestones and royalties. The first U.S. commercial sale of KOMZIFTI in late 2025 triggered a $135 million milestone payment expected by the end of 2025, which helps offset these initial launch costs.

Here's a quick look at the key operating expense components and guidance as of late 2025:

Cost Component	Q3 2025 Amount (USD Millions)	Q3 2024 Amount (USD Millions)	Context
Research and Development (R&D) Expense	$67.9	$41.7	Phase 3 scale-up for ziftomenib (KOMET-017)
General and Administrative (G&A) Expense	$32.8	$18.2	Pre-commercial activities and team build-out
Total Operating Expenses (R&D + G&A)	$100.7	$59.9	Drove quarterly net loss of $74.1 million
2025 Total Operating Expenses Guidance	$250 - $260	N/A	Reduced guidance from previous $270 - $285 million range

The company's cash position as of September 30, 2025, was $549.7 million, which, when adjusted for the two $30 million milestone payments received in October and November 2025 from the KOMET-017 trial, brought the pro forma cash to $609.7 million. Management believes this cash, combined with anticipated collaboration funding, supports the ziftomenib AML program through topline results from KOMET-017 into 2027.

• - High R&D spend driven by two global Phase 3 trials.
• - G&A rising due to pre-commercialization efforts post-NDA acceptance.
• - Manufacturing/supply chain costs partially offset by Kyowa Kirin profit-sharing.
• - Non-cash share-based compensation expense in Q3 2025 was $11.0 million.
• - Cash runway extends into 2027 based on current plans.

Kura Oncology, Inc. (KURA) - Canvas Business Model: Revenue Streams

You're looking at Kura Oncology, Inc.'s revenue structure as of late 2025, right after a major regulatory win. This is where the partnership with Kyowa Kirin really starts paying off, moving beyond just research funding to actual commercial realization.

The most immediate new stream is tied directly to the U.S. launch of KOMZIFTI (ziftomenib). The first U.S. commercial sale, following the FDA approval on November 13, 2025, immediately triggered a significant cash event.

• - Product sales revenue from U.S. commercialization of Komzifti (post-Nov 2025 approval): The first U.S. commercial sale triggered a $135 million milestone payment from Kyowa Kirin, which Kura Oncology expected to receive prior to year-end 2025.

The core of Kura Oncology, Inc.'s current financial inflow remains the collaboration with Kyowa Kirin. This covers cost-sharing, development milestones, and future sales participation.

Here's a breakdown of the collaboration's financial components:

Revenue Component	Specific Amount/Detail
Upfront Collaboration Payment (Historical)	$330 million
Q3 2025 Collaboration Revenue	$20.8 million
Total Near-Term Milestones Anticipated	Approximately $315 million
Total Milestones Received in 2025 (to early Dec)	$105 million (from two $30 million clinical trial milestones plus the $135 million commercial sale milestone)
Total Potential Milestones (Original Deal)	Up to $1.2 billion

The profit split on U.S. sales is 50/50 between Kura Oncology, Inc. and Kyowa Kirin, with Kura handling U.S. commercialization and sales reporting. This means half of the U.S. net profits flow back to Kura Oncology, Inc. after the initial milestone payments.

For territories outside the U.S., where Kyowa Kirin holds exclusive commercialization rights, Kura Oncology, Inc. secures passive income based on product performance.

• - Potential future milestone payments, with approximately $315 million in near-term milestones anticipated.
• - Tiered royalties on ex-U.S. sales of ziftomenib by Kyowa Kirin: These are structured as tiered double-digit royalties on sales.

The estimated annual U.S. market size for the currently approved indication (relapsed/refractory NPM1-mutated AML) is approximately $350-$400 million per year, based on an estimated price of $48,500 per 30-day bottle.

Finance: draft 13-week cash view by Friday.