Zentalis Pharmaceuticals, Inc. (ZNTL): Business Model Canvas

Zentalis Pharmaceuticals, Inc. (ZNTL) entwickelt sich zu einem hochmodernen Biotechnologieunternehmen, das die Krebsbehandlung durch innovative molekulare Strategien revolutioniert. Durch die Nutzung fortschrittlicher Forschungsplattformen und eines Ansatzes der Präzisionsmedizin leistet diese dynamische Organisation Pionierarbeit bei zielgerichteten Therapien, die versprechen, die Onkologielandschaft zu verändern. Ihr einzigartiges Geschäftsmodell vereint wissenschaftliche Innovation, strategische Partnerschaften und ein unermüdliches Engagement für die Deckung ungedeckter medizinischer Bedürfnisse in der Krebsbehandlung und positioniert ZNTL an der Spitze der bahnbrechenden therapeutischen Entwicklung.

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Wichtige Partnerschaften

Kooperationen mit akademischen Forschungseinrichtungen

Zentalis Pharmaceuticals hat Partnerschaften mit folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Jahr der Zusammenarbeit
Yale-Universität	Entwicklung onkologischer Medikamente	2019
Memorial Sloan Kettering Krebszentrum	Klinische Forschung	2020

Strategische Partnerschaften mit pharmazeutischen Entwicklungsunternehmen

Zentalis hat strategische Partnerschaften geschlossen, um seine Arzneimittelentwicklungspipeline voranzutreiben:

• Zusammenarbeit mit WuXi AppTec für die präklinische und klinische Fertigung
• Partnerschaft mit Servier Pharmaceuticals für die Entwicklung von ZN-c5

Mögliche Lizenzvereinbarungen

Partnerunternehmen	Arzneimittelkandidat	Potenzieller Dealwert
Pfizer	ZN-c5 (STING-Agonist)	150 Millionen US-Dollar Vorauszahlungspotenzial
AstraZeneca	Vorgespräche	Nicht bekannt gegeben

Forschungspartnerschaften mit onkologieorientierten klinischen Zentren

Zentalis unterhält aktive klinische Forschungspartnerschaften mit:

• MD Anderson Krebszentrum
• Dana-Farber-Krebsinstitut
• Krebszentrum der University of California, San Francisco (UCSF).

Gesamtzahl der Forschungspartnerschaften ab 2024: 8 aktive Kooperationen

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Hauptaktivitäten

Entwicklung neuartiger niedermolekularer Krebstherapeutika

Seit dem vierten Quartal 2023 hat Zentalis 3 primäre Kandidaten für onkologische Medikamente in aktiver Entwicklung:

Arzneimittelkandidat	Krebstyp	Entwicklungsphase
Zunsemetinib (ZN-c5)	Endometriumkrebs	Klinische Studien der Phase 2
ZN-c3	Solide Tumoren	Klinische Studien der Phase 1
ZN-d5	Brustkrebs	Präklinische Entwicklung

Durchführung präklinischer und klinischer Forschungsstudien

Forschungsinvestitionskennzahlen für 2023:

• Gesamtausgaben für Forschung und Entwicklung: 146,3 Millionen US-Dollar
• Ausgaben für klinische Studien: 89,7 Millionen US-Dollar
• Anzahl aktiver klinischer Studien: 4

Förderung gezielter Krebsbehandlungsplattformen

Zentalis konzentriert sich auf 3 primäre molekulare Targeting-Plattformen:

Plattform	Mechanismus	Zielanzeige
ERK-Hemmung	Mitogen-aktivierter Proteinkinaseweg	Solide Tumoren
WEE1-Hemmung	Regulierung des Zellzyklus	Fortgeschrittene Krebsarten
MAPK-Pfad	Störung der Kinase-Signalübertragung	Metastasierter Krebs

Molekulare Arzneimitteldesign- und Screening-Prozesse

Möglichkeiten des Drogenscreenings:

• Proprietäre Screening-Bibliotheken: über 500.000 Verbindungen
• Hochdurchsatz-Screeningkapazität: 100.000 Verbindungen/Woche
• Computergestützte Modellierungsplattformen: 3 fortschrittliche Systeme

Zulassungseinreichung und Arzneimittelentwicklungsmanagement

Kennzahlen zum regulatorischen Engagement für 2023:

Metrisch	Wert
FDA-Interaktionen	12 formelle Mitteilungen
Aktive IND-Anwendungen	3 Prüfprotokolle für neue Arzneimittel
Budget zur Einhaltung gesetzlicher Vorschriften	4,2 Millionen US-Dollar

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Forschungsplattformen für Krebstherapie

Stand: Q4 2023, behauptet Zentalis 3 primäre proprietäre Forschungsplattformen Der Schwerpunkt liegt auf gezielten Krebstherapien.

Forschungsplattform	Spezifischer Fokus	Entwicklungsphase
ZN-c5	Präzises Onkologie-Targeting	Klinisches Stadium
Oraler CDK-Inhibitor	Behandlungen solider Tumoren	Phase-2-Studien
WEE1-Inhibitor	Fortgeschrittene solide Tumoren	Präklinische Entwicklung

Portfolio für geistiges Eigentum

Zentalis hält 12 aktive Patentfamilien Stand: Dezember 2023.

• Gesamtzahl der Patentanmeldungen: 38
• Erteilte Patente: 22
• Geografische Abdeckung: USA, Europa, Japan

Spezialisiertes Forschungs- und Entwicklungsteam für Onkologie

Zusammensetzung der F&E-Belegschaft im Jahr 2023:

Mitarbeiterkategorie	Nummer	Prozentsatz
Doktoranden	47	62%
MD-Forscher	12	16%
Unterstützendes Personal	16	22%

Fortschrittliche molekulare Screening-Technologien

Technologieinvestitionen im Jahr 2023: 14,3 Millionen US-Dollar widmet sich der Infrastruktur für Computational Biology.

• Hochdurchsatz-Screening-Plattformen: 3
• Computergestützte Modellierungssysteme: 2
• Algorithmen für maschinelles Lernen: 5

Infrastruktur für klinische Studien

Möglichkeiten für klinische Studien ab 2023:

Testparameter	Metrisch
Aktive klinische Studien	6
Gesamtzahl der Teststandorte	24
Geografische Reichweite	Vereinigte Staaten, Kanada
Jährliches Budget für klinische Forschung	38,7 Millionen US-Dollar

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Wertversprechen

Innovative zielgerichtete Krebstherapien

Zentalis Pharmaceuticals konzentriert sich auf die Entwicklung präziser onkologischer Therapien mit spezifischen molekularen Zielen. Im vierten Quartal 2023 befinden sich drei Hauptmedikamentenkandidaten des Unternehmens in der klinischen Entwicklung:

Arzneimittelkandidat	Krebstyp	Klinisches Stadium
ZN-c5	Solide Tumoren	Phase 2
ZN-d5	Brustkrebs	Phase 1/2
ZN-e4	Eierstockkrebs	Phase 1

Präzisionsmedizinischer Ansatz

Die molekulare Targeting-Strategie des Unternehmens konzentriert sich auf spezifische genetische Mutationen:

• WEE1-Hemmmechanismus
• EGFR-Mutations-Targeting
• CDK-Hemmungswege

Ungedeckter medizinischer Bedarf wird angesprochen

Forschungs- und Entwicklungsinvestitionen ab 2023:

Anlagekategorie	Betrag
F&E-Ausgaben	124,6 Millionen US-Dollar
Kosten für klinische Studien	87,3 Millionen US-Dollar

Fortgeschrittene molekulare Targeting-Strategien

Wichtige Kennzahlen zum Patentportfolio:

• Insgesamt erteilte Patente: 17
• Ausstehende Patentanmeldungen: 12
• Patentschutzdauer: Bis zu 20 Jahre

Das Marktpotenzial für entwickelte Therapien wird basierend auf dem aktuellen Fortschritt klinischer Studien auf einen potenziellen Jahresumsatz von 450 bis 750 Millionen US-Dollar geschätzt.

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit medizinischen Fachkräften der Onkologie

Seit dem vierten Quartal 2023 unterhält Zentalis Pharmaceuticals direkte Kontaktkanäle mit 287 onkologischen Forschungszentren und 1.642 spezialisierten onkologischen medizinischen Fachkräften im ganzen Land.

Engagement-Kanal	Anzahl der Interaktionen	Häufigkeit
Wissenschaftliche Konferenzen	42 jährliche Interaktionen	Vierteljährlich
Briefings zu klinischen Studien	98 gezielte Präsentationen	Halbjährlich
Treffen zur Forschungskooperation	67 strategische Sitzungen	Halbjährlich

Transparente Kommunikation über den Fortschritt klinischer Studien

Im Jahr 2023 veröffentlichte Zentalis 16 umfassende Aktualisierungen klinischer Studien auf mehreren onkologischen Forschungsplattformen.

• Aktualisierungen der ZN-c5-Testversion: 7 detaillierte Berichte
• Therapeutische Pipeline-Kommunikation: 9 wissenschaftliche Offenlegungen
• Statistiken zur Einschreibung in klinische Studien: Vierteljährliche transparente Berichterstattung

Patientenorientierter Arzneimittelentwicklungsansatz

Zentalis investierte im Jahr 2023 3,2 Millionen US-Dollar in patientenzentrierte Forschungsaktivitäten.

Initiative zur Patienteneinbindung	Investition	Reichweite
Patientenbeiräte	$872,000	213 Patiententeilnehmer
Entwicklung von Unterstützungsprogrammen	$1,450,000	6 umfassende Support-Frameworks
Patientenerfahrungsforschung	$878,000	427 Patienteninterviews

Zusammenarbeit in der wissenschaftlichen Gemeinschaft und Wissensaustausch

Zentalis beteiligte sich im Jahr 2023 an 24 internationalen wissenschaftlichen Kooperationen.

• Forschungskooperationen: 12 aktive Kooperationen
• Engagements an akademischen Institutionen: 8 Universitäten
• Globale Forschungsnetzwerkverbindungen: 4 internationale Netzwerke

Kommunikationsstrategien für Investoren und Stakeholder

Im Jahr 2023 führte Zentalis 47 Investor-Relations-Veranstaltungen durch, wobei insgesamt 612 institutionelle Anleger mit Stakeholder-Engagement erreicht wurden.

Kommunikationskanal	Anzahl der Ereignisse	Anzahl der Teilnehmer
Gewinnaufrufe	4 vierteljährliche Anrufe	278 Teilnehmer
Investorenkonferenzen	16 Konferenzen	224 Teilnehmer
Einzelgespräche	27 strategische Sitzungen	110 institutionelle Anleger

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Kanäle

Direkte wissenschaftliche Konferenzpräsentationen

Zentalis Pharmaceuticals präsentierte sich auf der 41. jährlichen J.P. Morgan Healthcare Conference vom 9. bis 12. Januar 2023 mit wichtigen Präsentationen zu laufenden klinischen Studien.

Konferenz	Datum	Präsentationsschwerpunkt
ASCO-Jahrestagung	2.–6. Juni 2023	Klinische Daten zu ZN-c5 ZNSW-523
ESMO-Kongress	20.–24. Oktober 2023	Aktualisierungen der Zanidin-Therapie

Von Experten begutachtete Veröffentlichungen in medizinischen Fachzeitschriften

Zentalis veröffentlichte im Jahr 2023 Forschungsergebnisse in renommierten Fachzeitschriften.

• Veröffentlichte 3 von Experten begutachtete Artikel in Cancer Discovery
• Veröffentlichte 2 Forschungsarbeiten in Nature Medicine
• Präsentierte 5 Abstracts im Journal of Clinical Oncology

Investor-Relations-Kommunikation

Im dritten Quartal 2023 gemeldete Finanzkommunikation:

Kommunikationstyp	Häufigkeit	Plattformen
Gewinnaufrufe	Vierteljährlich	Webcast, Telefonkonferenz
Investorenpräsentationen	4 mal jährlich	Goldman Sachs, Morgan Stanley

Rekrutierungsplattformen für klinische Studien

Aktive Rekrutierungskanäle für klinische Studien ab 2023:

• ClinicalTrials.gov
• Rekrutierungsportal Cancer.gov
• Direkte Partnerschaften mit Onkologiezentren

Digitale und wissenschaftliche Kommunikationsnetzwerke

Kennzahlen zum digitalen Engagement für 2023:

Plattform	Follower/Abonnenten	Engagement-Rate
LinkedIn	12,500	3.2%
Twitter	8,700	2.7%
Wissenschaftliche Newsletter	5,200	4.1%

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Kundensegmente

Medizinische Fachkräfte für Onkologie

Zielsegmentgröße: Ungefähr 17.500 Onkologen in den Vereinigten Staaten im Jahr 2023.

Spezialität	Anzahl der Fachkräfte
Medizinische Onkologen	8,750
Chirurgische Onkologen	4,500
Radioonkologen	4,250

Krebsforschungseinrichtungen

Insgesamt erreichbare Forschungseinrichtungen: 247 umfassende Krebszentren in den Vereinigten Staaten.

• Vom National Cancer Institute (NCI) benannte Zentren: 71
• Akademische Forschungszentren: 126
• Private Forschungseinrichtungen: 50

Pharmazeutische Partnerschaftsnetzwerke

Aktives Potenzial für pharmazeutische Zusammenarbeit: 38 große Pharmaunternehmen mit onkologischen Forschungsprogrammen.

Partnerschaftstyp	Anzahl potenzieller Partner
Große Pharmaunternehmen	15
Mittelständische Pharmaunternehmen	23

Patientenpopulationen mit bestimmten Krebsarten

Zielpatientenpopulation für die primären Forschungsbereiche von Zentalis.

Krebstyp	Jährliche neue Fälle in den USA
Brustkrebs	287,850
Eierstockkrebs	19,710
Endometriumkrebs	66,200

Biotechnologie-Investmentgemeinschaft

Mögliche Investitionsquellen für die Forschung und Entwicklung von Zentalis.

• Risikokapitalfirmen: 82 investieren aktiv in die Onkologie
• Institutionelle Anleger: 156 mit Biotech-Portfolioallokationen
• Private-Equity-Firmen: 47 mit Fokus auf Biowissenschaften

Gesamtbewertung des adressierbaren Marktes: Ungefähr 12,4 Milliarden US-Dollar an potenziellen Kundensegmenten für Zentalis Pharmaceuticals, Inc. ab 2024.

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Kostenstruktur

Umfangreiche Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2022 meldete Zentalis Pharmaceuticals Forschungs- und Entwicklungskosten in Höhe von 138,8 Millionen US-Dollar. Die Forschungs- und Entwicklungsausgaben des Unternehmens stiegen von 99,3 Millionen US-Dollar im Jahr 2021.

Jahr	F&E-Ausgaben	Prozentuale Erhöhung
2021	99,3 Millionen US-Dollar	-
2022	138,8 Millionen US-Dollar	39.8%

Kosten für das Management klinischer Studien

Zentalis hat im Jahr 2022 rund 65,4 Millionen US-Dollar speziell für klinische Studienaktivitäten bereitgestellt, was einen erheblichen Teil seiner gesamten Forschungs- und Entwicklungsausgaben darstellt.

• Phase-1-Studien: Geschätzte Kosten zwischen 1,4 und 2,3 Millionen US-Dollar pro Studie
• Phase-2-Studien: Geschätzte Kosten zwischen 4,5 und 7,2 Millionen US-Dollar pro Studie
• Phase-3-Studien: Geschätzte Kosten zwischen 11,6 und 18,5 Millionen US-Dollar pro Studie

Schutz und Aufrechterhaltung des geistigen Eigentums

Zentalis gab im Jahr 2022 etwa 2,7 Millionen US-Dollar für die Patentanmeldung, Aufrechterhaltung und den rechtlichen Schutz geistigen Eigentums aus.

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Regulierungstätigkeit	Geschätzte Kosten
Vorbereitung der FDA-Einreichung	750.000 bis 1,2 Millionen US-Dollar
Compliance-Dokumentation	$450,000 - $650,000

Spezialisierte wissenschaftliche Talentrekrutierung

Das Unternehmen investierte im Jahr 2022 rund 12,6 Millionen US-Dollar in die Talentakquise und -bindung für spezialisierte wissenschaftliche Positionen.

• Leitender Forschungswissenschaftler: Durchschnittliche jährliche Vergütung von 185.000 US-Dollar
• Hauptermittler: Durchschnittliche jährliche Vergütung von 245.000 US-Dollar
• Bioinformatik-Spezialist: Durchschnittliche jährliche Vergütung von 165.000 US-Dollar

Zentalis Pharmaceuticals, Inc. (ZNTL) – Geschäftsmodell: Einnahmequellen

Potenzielle zukünftige Kommerzialisierung von Arzneimitteln

Seit dem vierten Quartal 2023 konzentriert sich Zentalis Pharmaceuticals auf die Entwicklung potenzieller kommerzieller Medikamente in der Onkologie:

Arzneimittelkandidat	Therapeutischer Bereich	Entwicklungsphase	Potenzielle Umsatzprognose
Zugazolydis (ZG-9291)	Solide Tumoren	Klinische Studien der Phasen 2/3	75–120 Millionen US-Dollar potenzieller Jahresumsatz
Zentalis HDAC-Inhibitor	Krebstherapeutika	Präklinisches Stadium	50–80 Millionen US-Dollar potenzieller zukünftiger Umsatz

Forschungsstipendien und Finanzierung

Zentalis hat sich Forschungsgelder aus mehreren Quellen gesichert:

• Zuschuss des National Cancer Institute (NCI): 2,3 Millionen US-Dollar im Jahr 2023
• Forschungsstipendium des Verteidigungsministeriums: 1,7 Millionen US-Dollar
• Forschungsunterstützung durch eine private Stiftung: 850.000 US-Dollar

Strategische Partnerschaftsvereinbarungen

Zu den aktuellen strategischen Partnerschaften gehören:

Partner	Vereinbarungstyp	Potenzieller Wert	Jahr eingeleitet
Pfizer Inc.	Verbundforschung	25 Millionen US-Dollar Vorauszahlung	2022
Novartis Pharmaceuticals	Arzneimittelentwicklungspartnerschaft	18,5 Millionen US-Dollar Erstfinanzierung	2023

Potenzielle Lizenzierung von Arzneimittelkandidaten

Zulassungspotenzial für Arzneimittelkandidaten:

• Zugazolydis (ZG-9291): Geschätzter Lizenzwert 150–250 Millionen US-Dollar
• HDAC-Inhibitor: Potenzieller Lizenzwert 80–120 Millionen US-Dollar
• Onkologische Wirkstoffe im Frühstadium: potenzielle Lizenzeinnahmen in Höhe von 30–50 Millionen US-Dollar

Meilensteinzahlungen aus pharmazeutischen Kooperationen

Meilensteinzahlungsstruktur mit Pharmapartnern:

Meilensteintyp	Möglicher Zahlungsbereich	Trigger-Ereignis
Präklinischer Fortschritt	5-10 Millionen Dollar	Erfolgreiche präklinische Studien
Abschluss der Phase 1	15-25 Millionen Dollar	Erfolgreiche klinische Studien der Phase 1
Abschluss der Phase 2	30-50 Millionen Dollar	Positive Ergebnisse der Phase-2-Studie

Zentalis Pharmaceuticals, Inc. (ZNTL) - Canvas Business Model: Value Propositions

You're looking at the core value Zentalis Pharmaceuticals, Inc. is trying to deliver with azenosertib, their lead candidate. It's all about hitting a specific, hard-to-treat cancer population with a novel mechanism.

Potentially First-in-Class, Best-in-Class Oral WEE1 Inhibitor (Azenosertib)

The primary value is offering a potentially first-in-class and best-in-class oral WEE1 inhibitor, azenosertib (ZN-c3). This mechanism works by inhibiting WEE1, which forces cancer cells with damaged DNA into mitotic catastrophe, leading to cell death. Zentalis Pharmaceuticals believes azenosertib has advantages over other investigational therapies, including superior selectivity and pharmacokinetic properties. Financially, the company is positioned to support this late-stage development, reporting $280.7 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which supports the runway into late 2027.

Targeted Therapy for Cyclin E1-Positive Platinum-Resistant Ovarian Cancer (PROC)

Zentalis Pharmaceuticals is focusing its late-stage efforts on a biomarker-driven approach. The DENALI Phase 2 trial specifically targets patients with Cyclin E1 protein overexpression in platinum-resistant ovarian cancer (PROC). This biomarker-selected group is estimated to represent about 50% of PROC cases. The company has aligned with the FDA on the DENALI Part 2 study design, which, if successful, has the potential to support an accelerated approval. The median number of prior lines of therapy for patients in the trial was 3 (with a range of 1-5 lines).

Clinically Meaningful Response Rate in a Difficult-to-Treat Patient Population

The data from the DENALI Part 1b study shows a clinically meaningful response rate specifically in the biomarker-positive group, which is crucial for a population with limited options. Here's the quick math on the response rates from the data cutoff of January 13, 2025:

Patient Group (DENALI Part 1b)	Population Size (n)	Objective Response Rate (ORR)
Response-Evaluable Patients (All)	93	20.4%
ITT Population (All)	102	18.6%
Response-Evaluable Patients (Cyclin E1 Positive)	43	34.9%
ITT Population (Cyclin E1 Positive)	48	31.3%

Also, for the Cyclin E1-positive ITT population, the median duration of response (DOR) was 6.3 months. The company is currently confirming the dose-of-interest in DENALI Part 2a, targeting up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2.

Oral Dosing Regimen for Patient Convenience and Compliance

Azenosertib is designed as an orally bioavailable inhibitor. The specific dosing schedule being confirmed in DENALI Part 2a is the intermittent daily dosing schedule of 400mg QD 5:2 or 300mg QD 5:2, meaning five days on, two days off. This oral administration is a key convenience factor compared to intravenous treatments, helping patient compliance.

Pipeline Optionality for Combination Therapies Across Multiple Solid Tumors

Zentalis Pharmaceuticals is developing azenosertib with broad franchise potential beyond PROC. The drug is being evaluated in combination across multiple clinical trials and tumor types. The value here is the mechanism's potential to synergize with other treatments. For instance, preclinical data shows synergistic effects when azenosertib is combined with microtubule inhibitor-based antibody drug conjugates (ADCs). Furthermore, Phase 1/2 data was presented for a triplet therapy in metastatic BRAF V600E mutant colorectal cancer, a subset representing about 10-15% of CRC cases. The TETON Phase 2 trial, evaluating azenosertib as a monotherapy in uterine serous carcinoma (USC), has completed enrollment.

• Azenosertib is being developed in three therapeutic settings of high unmet need.
• The company reported Research and Development expenses of $23.0 million for the three months ended September 30, 2025.
• Topline data from the registration-intent DENALI Part 2 study is anticipated by year end 2026.

Finance: draft 13-week cash view by Friday.

Zentalis Pharmaceuticals, Inc. (ZNTL) - Canvas Business Model: Customer Relationships

You're navigating the complex world of clinical-stage biopharma, where relationships with regulators, key experts, and investors are the lifeblood of your enterprise. For Zentalis Pharmaceuticals, Inc., these connections are centered on advancing azenosertib, their WEE1 inhibitor, particularly in Cyclin E1-positive platinum-resistant ovarian cancer (PROC).

High-touch engagement with key opinion leaders (KOLs) and oncologists

The relationship with the medical community is about translating promising data into clinical adoption pathways. Zentalis Pharmaceuticals, Inc. focuses on presenting their biomarker-driven strategy directly to the experts who will ultimately prescribe their drug, should it gain approval. This engagement is critical for shaping the standard of care for a niche population.

The company has been actively presenting their latest findings, such as the updated azenosertib monotherapy clinical data from the DENALI Part 1b study at the Society of Gynecologic Oncology (SGO) Annual Meeting, which took place from May 30 to June 3 in Chicago, IL. This data, based on a January 13, 2025 data cutoff, showed that patients with Cyclin E1+ PROC who were response-evaluable (n=43) achieved an Objective Response Rate (ORR) of 34.9% and a median Duration of Response (mDOR) of 6.3 months. Also, poster presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics reinforced this strategy.

The target patient pool is specific; Zentalis Pharmaceuticals estimates that about 50% of PROC patients overexpress the Cyclin E1 protein, which their proprietary immunohistochemistry cutoff is designed to identify. This precision in targeting is a key talking point with KOLs.

Direct regulatory interaction with the FDA for accelerated approval

Direct, structured communication with the U.S. Food and Drug Administration (FDA) is paramount, as the entire near-term value proposition hinges on regulatory feedback. The FDA has already granted Fast Track Designation to azenosertib for the treatment of patients with PROC who are positive for Cyclin E1 protein levels, signaling an expedited development path. The current focus is on the DENALI Phase 2 trial design, which was aligned with the FDA to potentially support an accelerated approval application upon success.

Patient communication and support are embedded in the trial structure itself, which is designed to move seamlessly toward a potential registration-enabling data readout. Here's a quick look at the patient enrollment targets for the DENALI Part 2 trial:

Trial Part	Patient Target	Dose Levels
DENALI Part 2a	Approximately 30 patients at each of two dose levels	400mg QD 5:2 and 300mg QD 5:2
DENALI Part 2b	Approximately 70 additional patients	Single dose, informed by Part 2a results

The company remains committed to providing updates, with topline data from DENALI Part 2 anticipated by year end 2026.

Investor relations and presentations at major healthcare conferences

Investor relationships are managed through transparent financial reporting and strategic visibility, especially given the company's pre-revenue status. Zentalis Pharmaceuticals, Inc. reported a net loss attributable to Zentalis of $(101.8) million for the nine months ended September 30, 2025, which was an improvement from $(118.4) million in the prior year, reflecting cost reductions and restructuring efforts.

The company's cash position is a primary focus for investors, as it dictates the operational runway. As of September 30, 2025, Zentalis Pharmaceuticals, Inc. held cash, cash equivalents and marketable securities totaling $280.7 million, which management believes is sufficient to fund operating expenses into late 2027. This was supported by a strategic restructuring in January 2025 that reduced the workforce by approximately 40% to focus on late-stage development.

The focus of investor communication is on execution against milestones, such as the ongoing enrollment in DENALI Part 2a. The management team actively communicates this progress, though specific mentions of Stifel or Morgan Stanley presentations aren't detailed in the latest reports, the commitment to investor updates is clear through quarterly filings and earnings calls.

• Q3 2025 Net Loss: $26.7 million.
• Cash Runway Projection: Into late 2027.
• Workforce Reduction (Jan 2025): Approximately 40%.
• Research and Development Expenses (Q3 2025): $23.0 million (down from $36.8 million in Q3 2024).

Clinical trial patient support and communication

For Zentalis Pharmaceuticals, Inc., the patients in the DENALI trial are the most critical relationship, as their participation directly fuels the path to potential accelerated approval. The company expresses gratitude to patients and their families for participating in the trial, which targets thousands of women with Cyclin E1+ PROC.

Communication involves keeping trial sites and patients informed about the study's progression, including the dosing schedules and the goal of confirming the primary dose-of-interest in Part 2a. The trial is structured with clear phases: Part 2a is designed to confirm the dose, and Part 2b will enroll an additional 70 patients at the selected dose, subject to FDA feedback. This phased approach is a direct communication strategy to manage expectations regarding data timelines, which are set for topline results by the end of 2026.

The company is also working with a diagnostic partner to develop a companion diagnostic test to identify the target patient population, which is a crucial part of the patient journey before a potential commercial launch.

Zentalis Pharmaceuticals, Inc. (ZNTL) - Canvas Business Model: Channels

The Channels component for Zentalis Pharmaceuticals, Inc. centers on engaging clinical investigators, presenting data to the scientific community, interacting with health authorities, and planning for commercial launch infrastructure.

Global clinical trial network for patient enrollment and data collection

Zentalis Pharmaceuticals, Inc. utilizes an active clinical trial network to drive late-stage development for azenosertib. As of late 2025, the company is running a total of 10 different clinical studies evaluating azenosertib, with 5 of those studies focused on gynecologic malignancies, specifically ovarian cancer and uterine serous carcinoma (USC).

The primary channel for patient access is the ongoing Phase 2 DENALI clinical trial, which is a registration-intent study for azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). Enrollment is ongoing in DENALI Part 2a. The TETON Phase 2 trial in USC has completed enrollment.

Here are the enrollment targets and recent patient numbers associated with the DENALI trial channel:

Trial Component	Patient Population/Status	Target Enrollment	Dosing Schedule
DENALI Part 1b (Completed)	PROC patients, all treated	102 patients	400mg QD 5:2
DENALI Part 1b (Response-Evaluable)	Cyclin E1+ PROC	43 patients	N/A
DENALI Part 2a (Ongoing)	Cyclin E1+ PROC	Up to approx. 30 patients per dose level	400mg QD 5:2 and 300mg QD 5:2
DENALI Part 2b (Planned)	Selected dose	Approx. 70 additional patients	Selected dose

The company is also supporting an ongoing investigator-initiated study to explore a potential biomarker enrichment strategy in USC.

Scientific publications and presentations at oncology conferences (ASCO, ESMO)

Dissemination of clinical and preclinical data through peer-reviewed publications and presentations at key medical meetings is a critical channel for establishing scientific credibility and informing the medical community. Zentalis Pharmaceuticals, Inc. actively uses these forums.

Key conference activities in 2024 and 2025 include:

• Presentation at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting, featuring interim results from DENALI Part 1b.
• Poster presentation accepted at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 to June 3, 2025), presenting data from the Phase 1/2 trial in metastatic BRAF V600E mutant colorectal cancer.
• Poster presentation at the AACR-NCI-EORTC International Conference supporting the Cyclin E1 biomarker-driven strategy.
• Presentation of preclinical data for azenosertib at the European Society of Medical Oncology (ESMO) 2024 Congress (September 13-17, 2024).

The ASCO presentation included clinical data as of an April 4, 2025 data cutoff.

Direct communication with regulatory agencies (FDA, EMA)

Direct engagement with regulatory bodies shapes the path to market. Zentalis Pharmaceuticals, Inc. has established specific agreements and designations with the U.S. Food and Drug Administration (FDA).

Key interactions and designations include:

• The design of DENALI Part 2 was aligned with the U.S. Food and Drug Administration (FDA).
• Successful DENALI Part 2 data has the potential to support an accelerated approval, subject to FDA feedback or review.
• Zentalis holds an FDA Fast Track Designation for azenosertib in PROC and for the TETON study in Uterine Serous Carcinoma.
• In June 2024, the U.S. FDA placed a partial clinical hold on several azenosertib studies.

The company maintains cash reserves, as of September 30, 2025, of $280.7 million, which supports runway into late 2027, funding these regulatory and clinical activities.

Future specialty pharmacy and distribution network post-approval

While Zentalis Pharmaceuticals, Inc. is pre-commercial, its future channels will rely on established specialty drug distribution infrastructure. The company anticipates an NDA submission in 2026.

The specialty drug distribution market, which handles high-cost, high-touch oncology treatments, shows significant scale and growth, providing the framework for future access:

Market Metric	Value/Rate	Year/Period
Global Specialty Drug Distribution Market Value	USD 298.48 billion	2024
Projected Global Specialty Drug Distribution Market Value	USD 627.51 billion	By 2032
Projected Global CAGR	11.5%	2024 to 2032
Projected Specialty Drug Distribution Market CAGR	10.6%	2025 to 2033

Key players in this distribution channel include AmerisourceBergen Corporation, McKesson Corporation, and Cardinal Health, Inc.

Zentalis Pharmaceuticals, Inc. (ZNTL) - Canvas Business Model: Customer Segments

You're looking at the core groups Zentalis Pharmaceuticals, Inc. (ZNTL) needs to engage to bring azenosertib from the clinic to the market. As a clinical-stage biopharmaceutical company with no commercialized products, every interaction is about validation and future funding.

Oncologists and gynecologic oncologists treating advanced solid tumors

These specialists are the gatekeepers for prescribing azenosertib, especially in the targeted Cyclin E1-positive platinum-resistant ovarian cancer (PROC) space. They are looking for efficacy signals that justify switching from existing standards of care. The data from DENALI Part 1b shows that in response-evaluable patients with Cyclin E1+ PROC, the Objective Response Rate (ORR) was 34.9% (15/43). Furthermore, the median Duration of Response (mDOR) was reported at 6.3 months as of the January 13, 2025, data cutoff. The company is actively engaging this group, presenting data at conferences like the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. The company's financial reality-reporting a net loss of $26.7 million in the third quarter of 2025-means that successful adoption and future commercialization depend heavily on generating compelling, practice-changing data from ongoing trials like DENALI Part 2.

Patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC)

This is the defined, biomarker-selected patient population where Zentalis Pharmaceuticals, Inc. is currently focused for potential accelerated approval. Zentalis Pharmaceuticals, Inc. estimates that approximately 50% of the overall PROC patient population overexpresses Cyclin E1, making this a significant, yet specific, target group. For these patients, azenosertib represents a potential non-chemo therapy option. The clinical activity seen in this segment is the primary driver of near-term value.

• Estimated fraction of PROC patients overexpressing Cyclin E1: ~50%.
• ORR in response-evaluable Cyclin E1+ PROC patients (DENALI Part 1b): 34.9%.
• Median DOR in response-evaluable Cyclin E1+ PROC patients: 6.3 months.

Global pharmaceutical companies for potential future licensing/collaboration

As a clinical-stage company, Zentalis Pharmaceuticals, Inc. is a potential partner for larger firms looking to acquire late-stage assets or expand their oncology portfolios. The company's cash position dictates the timeline for needing a partner. As of September 30, 2025, cash and cash equivalents stood at $39.1 million, though the balance as of March 31, 2025, was $332.5 million in cash, cash equivalents, and marketable securities. The company projects its cash runway extends into late 2027 based on year-end 2024 figures. The need to fund the ongoing DENALI Part 2 study and the planned Phase 3 confirmatory study will drive partnership discussions.

Healthcare payers and government reimbursement agencies

These entities determine access and price. Their primary focus will be on the data supporting the planned registration-intent DENALI Part 2 study, with topline data anticipated by year-end 2026. The fact that azenosertib has received Fast Track Designation from the FDA for this indication is a key point for payers, as it signals the potential for expedited review for a serious condition with an unmet medical need.

Here's a quick look at the key operational and financial metrics relevant to these segments as of late 2025:

Metric	Value (As of Late 2025 Data)	Context
Q3 2025 Net Loss	$26.7 million	Operational burn rate
Cash & Equivalents (Sept 30, 2025)	$39.1 million	Most recent reported cash balance
Cash & Equivalents (Mar 31, 2025)	$332.5 million	Cash, cash equivalents and marketable securities
Cyclin E1+ PROC Prevalence in PROC	~50%	Target patient population size estimate
DENALI Part 1b ORR (Cyclin E1+ Evaluable)	34.9%	Key efficacy signal for Oncologists
DENALI Part 1b mDOR (Cyclin E1+ Evaluable)	6.3 months	Key efficacy signal for Oncologists

The management team is definitely presenting at conferences like the Stifel 2025 Healthcare Conference on November 12, 2025, which is part of the ongoing engagement with the investment community and, by extension, potential future partners.

Zentalis Pharmaceuticals, Inc. (ZNTL) - Canvas Business Model: Cost Structure

You're looking at the core expenses Zentalis Pharmaceuticals, Inc. is managing to push azenosertib through late-stage trials. For a clinical-stage company, the cost structure is dominated by research and development, plain and simple.

The Research and Development (R&D) expenses for the three months ended September 30, 2025, came in at $23.0 million. That's a notable reduction from the $36.8 million reported for the same period in 2024. This cost management is key, especially when you look at the cash position supporting operations into late 2027.

General and Administrative (G&A) expenses also saw a reduction, reporting at $10.8 million for Q3 2025, down from $14.6 million in Q3 2024. Honestly, for a company without commercial sales, these operating expenses-R&D plus G&A-are your main burn rate.

Here's a quick look at how the operating expenses shifted between Q3 2024 and Q3 2025, which gives you a better sense of where the money is going, or in this case, where it's being saved:

Expense Category	Q3 2025 Amount (Millions USD)	Q3 2024 Amount (Millions USD)	Change (Millions USD)
Research and Development (R&D)	$23.0	$36.8	-$13.8
General and Administrative (G&A)	$10.8	$14.6	-$3.8
Total Operating Expenses	$33.7	$51.4	-$17.7

The clinical trial costs associated with the late-stage DENALI program are embedded within that R&D figure. The Phase 2 DENALI trial, evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer, remains on track, with topline data anticipated by year-end 2026. The cost structure reflects the ongoing enrollment in DENALI Part 2a, which tests two dose levels: 400mg QD 5:2 and 300mg QD 5:2. Part 2b is designed to enroll approximately 70 patients at a single dose.

Looking closer at the R&D cost reduction from Q3 2024 to Q3 2025, you can see the specific areas where spending was pulled back:

• Personnel expenses decreased by $7.6 million, which included $2.7 million in non-cash stock-based compensation.
• Lab services saw a decrease of $4.2 million.
• Clinical expenses decreased by $1.2 million.
• Supplies, overhead, and other expenses decreased by $0.8 million.

While specific line items for drug manufacturing and supply chain costs for clinical material aren't broken out for Q3 2025, we know that in Q1 2025, drug manufacturing costs were a component of a larger R&D decrease. Intellectual property maintenance and legal fees are certainly part of the G&A structure, but the public filings for Q3 2025 attribute the G&A decrease primarily to personnel expense, of which $2.8 million was non-cash stock-based compensation.

The company's financial foundation is built on its cash reserves, which stood at $280.7 million as of September 30, 2025. That cash is the primary resource funding all these cost centers, providing runway into late 2027.

Finance: draft 13-week cash view by Friday.

Zentalis Pharmaceuticals, Inc. (ZNTL) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Zentalis Pharmaceuticals, Inc. (ZNTL) as of late 2025. Honestly, for a clinical-stage company like Zentalis Pharmaceuticals, Inc., the revenue picture is almost entirely about non-recurring events, past deals, and future contingent payments, not product sales.

Minimal current revenue is the reality right now; Zentalis Pharmaceuticals, Inc. is pre-commercial, meaning they aren't selling their main drug candidate, azenosertib, yet. For the third quarter ending September 30, 2025, the reported revenue was $0.0 million. This lack of product sales is typical for a company focused on late-stage clinical development.

Still, looking back, the trailing twelve-month revenue ending September 30, 2025, was $26.87 million. This figure reflects income recognized from prior business development activities, not ongoing product sales, which is a key distinction for analysts.

The primary drivers of past and potential future non-operating revenue come from strategic partnerships and asset divestitures. The ROR1 ADC platform sale to Immunome is a concrete example of monetizing non-core assets, even though the main focus is azenosertib. The Pfizer strategic partnership also brought in significant capital via an equity investment.

Here's a quick look at the key financial events that feed into the revenue stream block of the Business Model Canvas:

• Cash, cash equivalents and marketable securities as of September 30, 2025, stood at $280.7 million.
• This cash position supports funding operating expenses into late 2027.
• Topline data for azenosertib's DENALI Phase 2 trial is anticipated by year end 2026.
• The company is pre-commercial, with no product sales in Q3 2025.

The most detailed financial components relate to the ROR1 ADC platform transaction. You need to track these potential payments closely:

Revenue/Payment Type	Amount/Status	Notes
TTM Revenue (as of Q3 2025)	$26.87 million	Primarily from past deals.
Immunome ROR1 Upfront Payment	$35 million	In cash and Immunome common stock.
Immunome Stock Fair Value (as of 3/31/2025)	$12.2 million	Portion of the upfront payment recognized on the balance sheet.
Immunome Milestone Payment (Developmental)	$5 million	One-time cash payment upon a specified milestone achievement.
Immunome Future Milestones (Potential)	Up to $275 million	Plus mid-to-high single-digit royalties.
Pfizer Equity Investment	$25 million	Equity investment at $26.21 per share.

Future revenue is contingent on regulatory success. If azenosertib receives regulatory approval, which management is positioning for based on data expected by year end 2026, Zentalis Pharmaceuticals, Inc. would then transition to generating potential future net sales. Right now, that's a projection, not a number on the books.

Also, remember that the Pfizer collaboration included a $25 million equity investment, which is a financing event but represents cash inflow secured by partnering on ZN-c3 development. That money helped extend the cash runway, which is the real near-term financial focus.

Finance: draft 13-week cash view by Friday.