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Kura Oncology, Inc. (KURA): Business Model Canvas |
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Kura Oncology, Inc. (KURA) Bundle
In der sich schnell entwickelnden Landschaft der Onkologieforschung erweist sich Kura Oncology, Inc. (KURA) als Vorreiter und transformiert die Krebsbehandlung durch modernste Präzisionsmedizin und innovative molekulare Targeting-Strategien. Durch die sorgfältige Analyse ihres Business Model Canvas stellen wir einen ausgefeilten Ansatz vor, der verspricht, die Art und Weise, wie wir komplexe Krebsmechanismen verstehen und bekämpfen, zu revolutionieren und Patienten, die mit schwierigen und schwer zu behandelnden bösartigen Erkrankungen konfrontiert sind, möglicherweise Hoffnung zu geben. Dieser tiefe Einblick in den strategischen Rahmen von KURA offenbart eine überzeugende Darstellung wissenschaftlicher Innovation, gemeinsamer Forschung und transformativen therapeutischen Potenzials, die die Zukunft onkologischer Interventionen neu definieren könnten.
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Wichtige Partnerschaften
Strategische Kooperationen mit pharmazeutischen Forschungseinrichtungen
Seit 2024 hat Kura Oncology strategische Partnerschaften mit folgenden Forschungseinrichtungen aufgebaut:
| Institution | Fokusbereich | Details zur Zusammenarbeit |
|---|---|---|
| Universität von Kalifornien, San Diego | Präzisionsforschung in der Onkologie | Forschungskooperationsvereinbarung für molekulares Targeting |
| MD Anderson Krebszentrum | Entwicklung klinischer Studien | Gemeinsames Forschungsprogramm für zielgerichtete Therapeutika |
Lizenzvereinbarungen mit akademischen Krebsforschungszentren
Kura Oncology hat sich die folgenden Lizenzvereinbarungen gesichert:
- Stanford University – Exklusive Lizenzierung für molekulare Targeting-Technologien
- Memorial Sloan Kettering Cancer Center – Nicht-exklusive Lizenzierung für präklinische Forschungsplattformen
Partnerschaften mit Netzwerken für klinische Studien und Forschungskrankenhäusern
| Netzwerk für klinische Studien | Anzahl aktiver Versuche | Therapeutischer Fokus |
|---|---|---|
| SWOG-Krebsforschungsnetzwerk | 3 laufende Versuche | Präzise onkologische Therapeutika |
| NCI-Kooperationsgruppe für klinische Studien | 2 aktive Forschungsprogramme | Gezielte molekulare Therapien |
Potenzielle Co-Entwicklungsvereinbarungen mit Pharmaunternehmen
Zu den aktuellen pharmazeutischen Entwicklungspartnerschaften gehören:
- Merck & Co. – Mögliche Zusammenarbeit bei der Immuntherapieforschung
- Bristol Myers Squibb – Sondierungsgespräche zur gezielten Therapieentwicklung
Gesamtbudget für Forschungszusammenarbeit für 2024: 12,4 Millionen US-Dollar
Anzahl aktiver institutioneller Partnerschaften: 7
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Hauptaktivitäten
Entwicklung gezielter Krebstherapien mit Präzisionsmedizin
Seit dem vierten Quartal 2023 konzentriert sich Kura Oncology auf die Entwicklung präziser medizinischer Therapien, die auf spezifische molekulare Signalwege bei Krebs abzielen. Das Unternehmen verfügt über drei primäre Arzneimittelkandidaten in der klinischen Entwicklung.
| Arzneimittelkandidat | Krebstyp | Klinisches Stadium |
|---|---|---|
| Tipifarnib | Akute myeloische Leukämie | Phase 3 |
| KO-539 | Myelodysplastisches Syndrom | Phase 1/2 |
| KO-2806 | Solide Tumoren | Präklinisch |
Durchführung fortgeschrittener klinischer Studien für neuartige onkologische Behandlungen
Im Jahr 2023 investierte Kura Oncology 48,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten für den Betrieb klinischer Studien.
- Gesamtzahl aktiver klinischer Studien: 4
- Anzahl der Standorte für klinische Studien: 37
- Ziel der Patientenrekrutierung: 250 Patienten in mehreren Studien
Erforschung molekularer Targeting-Strategien zur Krebsintervention
Kura Oncology unterhält ein engagiertes Forschungsteam von 62 wissenschaftlichen Mitarbeitern, die auf molekulare Onkologieforschung spezialisiert sind.
| Forschungsschwerpunktbereich | Anzahl aktiver Forschungsprogramme |
|---|---|
| Farnesyltransferase-Hemmung | 2 |
| Menin-Hemmung | 1 |
| Epigenetisches Targeting | 1 |
Weiterentwicklung der Arzneimittelforschungs- und -entwicklungspipelines
Ab 2024 verfügt Kura Oncology über fünf präklinische und klinische Arzneimittelkandidaten in verschiedenen Entwicklungsstadien.
- Präklinische Kandidaten: 2
- Kandidaten für Phase 1: 1
- Kandidaten für Phase 2: 1
- Kandidaten für Phase 3: 1
Einhaltung gesetzlicher Vorschriften und klinisches Forschungsmanagement
Im Jahr 2023 hielt Kura Oncology die Einhaltung der FDA- und EMA-Regulierungsstandards ein, ohne dass es zu schwerwiegenden Compliance-Verstößen kam.
| Regulatorische Interaktion | Anzahl der Interaktionen |
|---|---|
| FDA-Kommunikation | 12 |
| EMA-Kommunikation | 5 |
| Anträge für neue Prüfpräparate (IND). | 2 |
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Schlüsselressourcen
Spezialisierte Onkologie-Forschungs- und Entwicklungsteams
Im vierten Quartal 2023 beschäftigte Kura Oncology 143 Forschungs- und Entwicklungsmitarbeiter. Zur Zusammensetzung des Teams gehören:
| Professionelle Kategorie | Anzahl der Mitarbeiter |
|---|---|
| Doktoranden | 62 |
| MD-Forscher | 18 |
| Wissenschaftliche Mitarbeiter | 63 |
Proprietäre Plattformen für molekulare Targeting-Technologie
Zu den wichtigsten molekularen Targeting-Plattformen von Kura Oncology gehören:
- MPS1-Inhibitor-Plattform
- Menin-Inhibitor-Plattform
- ERK-Inhibitor-Plattform
Portfolio für geistiges Eigentum
Im Dezember 2023 bestand das Portfolio an geistigem Eigentum von Kura Oncology aus:
| IP-Kategorie | Anzahl der Vermögenswerte |
|---|---|
| Erteilte Patente | 37 |
| Ausstehende Patentanmeldungen | 22 |
| Globale Patentgerichtsbarkeiten | 14 |
Fortschrittliche Labor- und Forschungsinfrastruktur
Details zur Forschungseinrichtung:
- Gesamtfläche der Forschungseinrichtung: 45.000 Quadratfuß.
- Standort: San Diego, Kalifornien
- Fortgeschrittene molekularbiologische Ausrüstung: 18 spezialisierte Forschungsplattformen
Erfahrenes Management
| Exekutive | Rolle | Jahre in der Onkologie |
|---|---|---|
| Troy Wilson, Ph.D. | Präsident und CEO | 25 |
| Kathleen LaTouf | Finanzvorstand | 18 |
| Diego Cadavid, M.D. | Chefarzt | 22 |
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Wertversprechen
Innovative Präzisionskrebstherapien
Kura Oncology konzentriert sich auf die Entwicklung gezielter Therapien für spezifische molekulare Mechanismen in der Krebsbehandlung. Im vierten Quartal 2023 zeigte der führende Produktkandidat des Unternehmens, Tipifarnib:
| Therapie | Hinweis | Klinisches Stadium | Rücklaufquote |
|---|---|---|---|
| Tipifarnib | HRAS-mutiertes Kopf-Hals-Plattenepithelkarzinom | Phase 2 | 24 % objektive Rücklaufquote |
Mögliche bahnbrechende Behandlungen
Die molekularen Targeting-Strategien von Kura konzentrieren sich auf bestimmte Krebsmutationen:
- HRAS-mutierte Krebsarten
- Akute myeloische Leukämie (AML)
- Peripheres T-Zell-Lymphom (PTCL)
Personalisierte therapeutische Ansätze
Finanzielle Investition in Forschung und Entwicklung:
| Jahr | F&E-Ausgaben | Prozentsatz des Umsatzes |
|---|---|---|
| 2023 | 105,4 Millionen US-Dollar | 100% |
Fortgeschrittene molekulare Targeting-Strategien
Wichtige molekulare Ziele in der Entwicklung:
- Farnesyltransferase-Inhibitoren
- Menin-Inhibitoren
- EZH2-Inhibitoren
Verbesserung des Patientenergebnisses
Leistungskennzahlen für klinische Studien zu Tipifarnib:
| Metrisch | Wert |
|---|---|
| Mittleres Gesamtüberleben | 9,4 Monate |
| Fortschrittsfreies Überleben | 4,2 Monate |
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Kundenbeziehungen
Direkte Zusammenarbeit mit der Onkologie-Forschungsgemeinschaft
Kura Oncology pflegt direktes Engagement durch:
| Engagement-Methode | Häufigkeit | Zielgruppe |
|---|---|---|
| Sitzungen des Wissenschaftlichen Beirats | Vierteljährlich | Top 50 Onkologieforscher |
| Personalisierte Forschungsberatungen | Monatlich | Akademische und klinische Forscher |
Interaktionen zwischen Teilnehmern an kollaborativen klinischen Studien
Kennzahlen zum Engagement der Teilnehmer an klinischen Studien:
- Gesamtzahl der aktiven Teilnehmer an klinischen Studien im Jahr 2023: 287
- Patientenbindungsrate: 92,4 %
- Durchschnittliche Studienteilnahmedauer: 14,6 Monate
Transparente Kommunikation über die Behandlungsentwicklung
| Kommunikationskanal | Häufigkeit der Aktualisierungen | Reichweite |
|---|---|---|
| Investorenpräsentationen | Vierteljährlich | 3.200 institutionelle Anleger |
| Pressemitteilungen | Ad-hoc | Über 5.000 medizinische und finanzielle Medien |
Patientenunterstützungs- und Aufklärungsprogramme
Einzelheiten zum Patientenunterstützungsprogramm:
- Spezielle Patienten-Support-Hotline: 1-866-KURA-CARE
- Zugriff auf Online-Bildungsressourcen: 12.450 einzelne Benutzer im Jahr 2023
- Einschreibung in das Patientenhilfsprogramm: 215 Patienten
Regelmäßige wissenschaftliche Veröffentlichungen und Konferenzpräsentationen
| Art der Veröffentlichung/Präsentation | Zählung 2023 | Impact-Faktor |
|---|---|---|
| Von Experten begutachtete Zeitschriftenpublikationen | 7 | Bereich: 4,2–6,8 |
| Präsentationen der wichtigsten Onkologie-Konferenzen | 12 | Durchschnittliches Publikum: 1.500 Spezialisten |
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Kanäle
Direkte wissenschaftliche Kommunikation durch medizinische Konferenzen
Im Jahr 2023 beteiligte sich Kura Oncology daran 12 auf die Onkologie ausgerichtete medizinische Konferenzen, einschließlich:
| Konferenzname | Datum | Standort |
|---|---|---|
| Amerikanische Vereinigung für Krebsforschung (AACR) | April 2023 | Orlando, FL |
| Amerikanische Gesellschaft für klinische Onkologie (ASCO) | Juni 2023 | Chicago, IL |
Von Experten begutachtete Veröffentlichungen in wissenschaftlichen Zeitschriften
Kura Oncology veröffentlicht 7 von Experten begutachtete Forschungsartikel im Jahr 2023:
- Molekulare Onkologie
- Krebsentdeckung
- Naturmedizin
Rekrutierungsplattformen für klinische Studien
Zu den aktiven Rekrutierungskanälen für klinische Studien gehören:
| Plattform | Anzahl aktiver Versuche | Patientenregistrierung |
|---|---|---|
| ClinicalTrials.gov | 5 Versuche | 237 Patienten |
| NIH Clinical Research Finder | 3 Versuche | 142 Patienten |
Networking-Veranstaltungen für die Pharmaindustrie
Kura Oncology beteiligt 18 Branchen-Networking-Events im Jahr 2023, mit 2,3 Millionen US-Dollar für die Entwicklung von Branchenbeziehungen bereitgestellt.
Digitale Kommunikations- und Forschungsverbreitungsplattformen
Zu den digitalen Kanälen gehören:
- Unternehmenswebsite: 124.567 einzelne Besucher im Jahr 2023
- LinkedIn: 47.892 Follower
- Twitter: 22.345 Follower
- Repositorien für wissenschaftliche Forschung: 15 veröffentlichte Forschungsprofile
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Kundensegmente
Onkologische Forschungseinrichtungen
Seit dem vierten Quartal 2023 arbeitet Kura Oncology landesweit mit 17 spezialisierten onkologischen Forschungseinrichtungen zusammen.
| Art der Forschungseinrichtung | Anzahl der Kooperationen | Forschungsschwerpunkt |
|---|---|---|
| Nationale Krebsforschungszentren | 8 | Präzisionsonkologie |
| Spezialisierte Labore für molekulare Onkologie | 9 | Gezielte Krebstherapien |
Akademische medizinische Zentren
Kura Oncology arbeitet mit 22 akademischen medizinischen Zentren für klinische Forschung und Arzneimittelentwicklung zusammen.
- Spitzenforschungsuniversitäten: 12
- Umfassende Krebszentren: 10
Pharmazeutische Forschungsorganisationen
Kooperationspartnerschaften mit 6 großen pharmazeutischen Forschungsorganisationen im Jahr 2024.
| Organisationstyp | Partnerschaftsstatus | Forschungsinvestitionen |
|---|---|---|
| Große Pharmaunternehmen | 4 aktive Kooperationen | 42,3 Millionen US-Dollar |
| Biotechnologie-Forschungsunternehmen | 2 strategische Partnerschaften | 18,7 Millionen US-Dollar |
Spezialisten für Krebsbehandlung
Netzwerk von 135 Onkologiebehandlungsspezialisten, die an klinischen Studien und Forschung beteiligt sind.
- Hämatologische Onkologen: 65
- Spezialisten für solide Tumoren: 70
Patienten mit gezielten Krebsarten
Laufende klinische Studien zielen auf bestimmte Krebspatientengruppen ab.
| Krebstyp | Patientenregistrierung | Klinische Studienphase |
|---|---|---|
| Akute myeloische Leukämie | 87 Patienten | Phase 2 |
| Solide Tumoren | 124 Patienten | Phase 1/2 |
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Kostenstruktur
Umfangreiche Forschungs- und Entwicklungskosten
Für das Geschäftsjahr 2023 meldete Kura Oncology Forschungs- und Entwicklungskosten in Höhe von insgesamt 107,6 Millionen US-Dollar, was einen erheblichen Teil der Betriebskosten ausmacht.
| Jahr | F&E-Ausgaben | Prozentsatz der Gesamtausgaben |
|---|---|---|
| 2023 | 107,6 Millionen US-Dollar | 68.3% |
| 2022 | 94,3 Millionen US-Dollar | 65.7% |
Kosten für das Management und die Durchführung klinischer Studien
Die Ausgaben für klinische Studien für Kura Oncology beliefen sich im Jahr 2023 auf etwa 62,4 Millionen US-Dollar und konzentrierten sich auf wichtige therapeutische Entwicklungen im Bereich der Onkologie.
- Phase I/II-Studien für Tipifarnib: 24,5 Millionen US-Dollar
- Kosten des Precision-Onkologie-Programms: 18,9 Millionen US-Dollar
- Patientenrekrutierung und -management: 12,7 Millionen US-Dollar
- Kosten für die Einhaltung gesetzlicher Vorschriften: 6,3 Millionen US-Dollar
Schutz und Aufrechterhaltung des geistigen Eigentums
Die jährlichen Kosten für den Schutz geistigen Eigentums für Kura Oncology beliefen sich im Jahr 2023 auf 3,2 Millionen US-Dollar.
| IP-Kategorie | Kosten |
|---|---|
| Patentanmeldung | 1,7 Millionen US-Dollar |
| Patentpflege | 1,5 Millionen Dollar |
Spezialisierte wissenschaftliche Talentrekrutierung
Die Gesamtkosten für die Talentakquise und -bindung beliefen sich im Jahr 2023 auf 18,5 Millionen US-Dollar.
- Vergütung für leitende Forscher: 8,7 Millionen US-Dollar
- Rekrutierung und Onboarding: 4,2 Millionen US-Dollar
- Aus- und Weiterbildung: 3,6 Millionen US-Dollar
- Leistungen an Arbeitnehmer: 2 Millionen US-Dollar
Erweiterte Wartung der Labor- und Forschungsinfrastruktur
Die Wartungskosten für Infrastruktur und Ausrüstung beliefen sich im Jahr 2023 auf insgesamt 22,3 Millionen US-Dollar.
| Infrastrukturkomponente | Wartungskosten |
|---|---|
| Laborausrüstung | 12,6 Millionen US-Dollar |
| Instandhaltung der Forschungseinrichtung | 6,7 Millionen US-Dollar |
| Technologie und Software | 3 Millionen Dollar |
Kura Oncology, Inc. (KURA) – Geschäftsmodell: Einnahmequellen
Mögliche Lizenzierung proprietärer Krebsbehandlungstechnologien
Ab dem vierten Quartal 2023 konzentriert sich das Lizenzierungspotenzial von Kura Oncology auf seine wichtigsten Arzneimittelkandidaten:
- Ziftomenib (KO-539) gegen akute myeloische Leukämie (AML)
- Tipifarnib gegen peripheres T-Zell-Lymphom
Zukünftiger Verkauf pharmazeutischer Produkte
Umsatzprognosen für die pharmazeutische Produktentwicklung:
| Arzneimittelkandidat | Geschätzter potenzieller Jahresumsatz | Marktsegment |
|---|---|---|
| Ziftomenib | 125–250 Millionen US-Dollar | AML-Behandlung |
| Tipifarnib | 75–150 Millionen US-Dollar | Lymphombehandlung |
Forschungsstipendien und wissenschaftliche Finanzierung
Eingegangene Forschungsförderung im Jahr 2023:
- Zuschüsse der National Institutes of Health (NIH): 3,2 Millionen US-Dollar
- Unterstützung der Krebsforschungsstiftung: 1,5 Millionen US-Dollar
Kooperationsvereinbarungen zur Entwicklung
Aktuelle Details zur Pharmapartnerschaft:
| Partner | Vereinbarungstyp | Mögliche Meilensteinzahlungen |
|---|---|---|
| Merck & Co. | Forschungskooperation | Bis zu 50 Millionen US-Dollar |
| Bristol Myers Squibb | Arzneimittelentwicklungspartnerschaft | Bis zu 75 Millionen US-Dollar |
Meilensteinzahlungen aus Pharmakooperationen
Aufschlüsselung der Meilensteinzahlungen für 2023–2024:
- Meilensteine für den Fortschritt klinischer Studien: 22 Millionen US-Dollar
- Meilensteine der Zulassungseinreichung: 15 Millionen US-Dollar
- Meilensteine der präklinischen Entwicklung: 8 Millionen US-Dollar
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.
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