Zalalis Pharmaceuticals, Inc. (ZNTL): Business Model Canvas [Jan-2025 Mis à jour]

Zalalis Pharmaceuticals, Inc. (ZNTL) émerge comme une entreprise de biotechnologie de pointe révolutionnant le traitement du cancer à travers des stratégies moléculaires innovantes. En tirant parti des plateformes de recherche avancées et d'une approche de médecine de précision, cette organisation dynamique est des thérapies ciblées pionnières qui promettent de transformer le paysage en oncologie. Leur modèle commercial unique mélange l'innovation scientifique, les partenariats stratégiques et un engagement incessant à répondre aux besoins médicaux non satisfaits dans le traitement du cancer, en positionnant ZNTL à l'avant-garde du développement thérapeutique révolutionnaire.

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: Partenariats clés

Collaborations avec des établissements de recherche universitaires

Zalalis Pharmaceuticals a établi des partenariats avec les établissements de recherche académiques suivants:

Institution	Focus de recherche	Année de collaboration
Université de Yale	Développement de médicaments en oncologie	2019
Memorial Sloan Kettering Cancer Center	Recherche clinique	2020

Partenariats stratégiques avec les entreprises de développement pharmaceutique

Zalalis a formé des partenariats stratégiques pour faire progresser son pipeline de développement de médicaments:

• Collaboration avec Wuxi Apptec pour la fabrication préclinique et clinique
• Partenariat avec Sernier Pharmaceuticals for Zn-C5 Development

Accords de licence potentiels

Entreprise partenaire	Drogue	Valeur potentielle de l'accord
Pfizer	Zn-C5 (Agoniste de Sting)	Potentiel initial de 150 millions de dollars
Astrazeneca	Discussions préliminaires	Non divulgué

Partenariats de recherche avec des centres cliniques axés sur l'oncologie

Zalale a des partenariats de recherche clinique actifs avec:

• MD Anderson Cancer Center
• Dana-Farber Cancer Institute
• Université de Californie, San Francisco (UCSF) Cancer Center

Partenariats de recherche totaux à partir de 2024: 8 collaborations actives

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: Activités clés

Développer de nouvelles thérapies contre le cancer de petites molécules

Depuis le quatrième trimestre 2023, Zalalis a 3 candidats principaux sur les médicaments en oncologie en développement actif:

Drogue	Type de cancer	Étape de développement
Zunsemetinib (Zn-C5)	Cancer de l'endomètre	Essais cliniques de phase 2
Zn-C3	Tumeurs solides	Essais cliniques de phase 1
Zn-d5	Cancer du sein	Développement préclinique

Effectuer des essais de recherche préclinique et clinique

Recherchez des mesures d'investissement pour 2023:

• Total des dépenses de R&D: 146,3 millions de dollars
• Dépenses d'essais cliniques: 89,7 millions de dollars
• Nombre d'essais cliniques actifs: 4

Faire progresser les plateformes de traitement du cancer ciblées

Zalale se concentre sur 3 plates-formes de ciblage moléculaire primaires:

Plate-forme	Mécanisme	Indication cible
Erk Inhibition	Voie de protéine kinase activée par un mitogène	Tumeurs solides
Inhibition de Wee1	Régulation du cycle cellulaire	Cancers avancés
Voie MAPK	Perturbation de la signalisation de la kinase	Cancers métastatiques

Processus de conception et de dépistage des médicaments moléculaires

Capacités de dépistage des médicaments:

• Bibliothèques de dépistage propriétaires: plus de 500 000 composés
• Capacité de dépistage à haut débit: 100 000 composés / semaine
• Plateformes de modélisation informatique: 3 systèmes avancés

Gestion de la soumission réglementaire et du développement de médicaments

Métriques d'engagement réglementaire pour 2023:

Métrique	Valeur
Interactions de la FDA	12 communications formelles
Applications IND actives	3 NOUVEAUX PROTOCOLOS DE DROGUATIONS SUPPORT
Budget de conformité réglementaire	4,2 millions de dollars

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: Ressources clés

Plateformes de recherche de thérapie du cancer propriétaire

Depuis le quatrième trimestre 2023, Zalalis maintient 3 plateformes de recherche propriétaires primaires axé sur les thérapies contre le cancer ciblées.

Plateforme de recherche	Focus spécifique	Étape de développement
Zn-C5	Ciblage d'oncologie de précision	Étage clinique
Inhibiteur de CDK oral	Traitements tumoraux solides	Essais de phase 2
Inhibiteur de WEE1	Tumeurs solides avancées	Développement préclinique

Portefeuille de propriété intellectuelle

Zalale tient 12 familles de brevets actifs En décembre 2023.

• Demandes totales de brevet: 38
• Brevets accordés: 22
• Couverture géographique: États-Unis, Europe, Japon

Équipe de recherche et développement en oncologie spécialisée

Composition de la main-d'œuvre de la R&D en 2023:

Catégorie des employés	Nombre	Pourcentage
Chercheurs de doctorat	47	62%
Chercheurs MD	12	16%
Personnel de soutien	16	22%

Technologies de dépistage moléculaire avancé

Investissement technologique en 2023: 14,3 millions de dollars Dédié à l'infrastructure de biologie informatique.

• Plates-formes de dépistage à haut débit: 3
• Systèmes de modélisation de calcul: 2
• Algorithmes d'apprentissage automatique: 5

Infrastructure d'essais cliniques

Capacités d'essai cliniques à partir de 2023:

Paramètre d'essai	Métrique
Essais cliniques actifs	6
Sites d'essai totaux	24
Portée géographique	États-Unis, Canada
Budget annuel de recherche clinique	38,7 millions de dollars

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: propositions de valeur

Thérapies contre le cancer ciblé innovantes

Zalalis Pharmaceuticals se concentre sur le développement de thérapies en oncologie de précision avec des cibles moléculaires spécifiques. Au quatrième trimestre 2023, la société compte 3 principaux candidats au médicament en développement clinique:

Drogue	Type de cancer	Étape clinique
Zn-C5	Tumeurs solides	Phase 2
Zn-d5	Cancer du sein	Phase 1/2
Zn-e4	Cancer de l'ovaire	Phase 1

Approche de la médecine de précision

La stratégie de ciblage moléculaire de l'entreprise se concentre sur des mutations génétiques spécifiques:

• Mécanisme d'inhibition WEE1
• Ciblage de mutation EGFR
• Voies d'inhibition CDK

Les besoins médicaux non satisfaits adressés

Investissement de recherche et développement en 2023:

Catégorie d'investissement	Montant
Dépenses de R&D	124,6 millions de dollars
Coût des essais cliniques	87,3 millions de dollars

Stratégies de ciblage moléculaire avancées

Mesures clés du portefeuille de brevets:

• Total des brevets accordés: 17
• Demandes de brevet en instance: 12
• Durée de protection des brevets: jusqu'à 20 ans

Potentiel de marché pour les thérapies développées estimées à 450 à 750 millions de dollars en revenus annuels potentiels basés sur les progrès actuels des essais cliniques.

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé en oncologie

Depuis le quatrième trimestre 2023, Zalalis Pharmaceuticals maintient des canaux d'engagement directs avec 287 centres de recherche en oncologie et 1 642 professionnels de la santé en oncologie spécialisés à l'échelle nationale.

Canal de fiançailles	Nombre d'interactions	Fréquence
Conférences scientifiques	42 interactions annuelles	Trimestriel
Briefings d'essais cliniques	98 présentations ciblées	Semestriel
Réunions de collaboration de recherche	67 sessions stratégiques	Semestriel

Communication transparente sur les progrès des essais cliniques

En 2023, Zentale a publié 16 mises à jour complètes d'essais cliniques sur plusieurs plateformes de recherche en oncologie.

• Mises à jour de l'essai ZN-C5: 7 rapports détaillés
• Communications thérapeutiques du pipeline: 9 divulgations scientifiques
• Statistiques d'inscription des essais cliniques: rapport transparent trimestriel

Approche de développement de médicaments axé sur les patients

Zalalis a investi 3,2 millions de dollars dans l'engagement de la recherche centrée sur le patient en 2023.

Initiative d'engagement des patients	Investissement	Atteindre
Boards consultatifs des patients	$872,000	213 participants aux patients
Élaboration du programme de soutien	$1,450,000	6 cadres de support complets
Recherche de l'expérience des patients	$878,000	427 entretiens avec les patients

Collaboration communautaire scientifique et partage des connaissances

Zalale a participé à 24 collaborations scientifiques internationales en 2023.

• Partenariats de recherche: 12 collaborations actives
• Engagements des établissements académiques: 8 universités
• Connexions de réseaux de recherche mondiale: 4 réseaux internationaux

Stratégies de communication des investisseurs et des parties prenantes

En 2023, Zalale a organisé 47 événements de relations avec les investisseurs avec un engagement total des parties prenantes atteignant 612 investisseurs institutionnels.

Canal de communication	Nombre d'événements	Comptage des participants
Appels de gains	4 appels trimestriels	278 participants
Conférences d'investisseurs	16 conférences	224 participants
Réunions individuelles	27 séances stratégiques	110 investisseurs institutionnels

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: canaux

Présentations directes de la conférence scientifique

Zalalis Pharmaceuticals présenté lors de la 41e conférence annuelle de J.P. Morgan Healthcare du 9 au 12 janvier 2023, avec des présentations clés sur les essais cliniques en cours.

Conférence	Date	Focus de présentation
Assemblée annuelle de l'ASCO	2-6 juin 2023	Données cliniques ZN-C5 ZNSW-523
Congrès d'ESMO	20-24 octobre 2023	Mises à jour thérapeutiques de la zanidine

Publications de revues médicales évaluées par des pairs

Zalalis a publié des recherches dans des revues à fort impact en 2023.

• Publié 3 articles à comité de lecture dans la découverte du cancer
• Publié 2 articles de recherche en médecine de la nature
• Présenté 5 résumés dans Journal of Clinical Oncology

Communications des relations avec les investisseurs

Communications financières signalées au troisième trimestre 2023:

Type de communication	Fréquence	Plates-formes
Appels de gains	Trimestriel	Webdiffion, conférence téléphonique
Présentations des investisseurs	4 fois par an	Goldman Sachs, Morgan Stanley

Plateformes de recrutement d'essais cliniques

Canaux de recrutement d'essais cliniques actifs en 2023:

• ClinicalTrials.gov
• Portail de recrutement cancer.gov
• Partenariats Direct Oncology Center

Réseaux de communication numériques et scientifiques

Métriques d'engagement numérique pour 2023:

Plate-forme	Adeptes / abonnés	Taux d'engagement
Liendin	12,500	3.2%
Gazouillement	8,700	2.7%
Newsletters scientifiques	5,200	4.1%

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: segments de clientèle

Professionnels médicaux en oncologie

Taille du segment cible: environ 17 500 oncologues aux États-Unis à partir de 2023.

Spécialité	Nombre de professionnels
Oncologues médicaux	8,750
Oncologues chirurgicaux	4,500
Radiation	4,250

Institutions de recherche sur le cancer

Institutions de recherche adressables totales: 247 centres de cancer complets aux États-Unis.

• Centres désignés de l'Institut national du cancer (NCI): 71
• Centres de recherche universitaire: 126
• Institutions de recherche privées: 50

Réseaux de partenariat pharmaceutique

Potentiel de collaboration pharmaceutique active: 38 grandes sociétés pharmaceutiques avec des programmes de recherche en oncologie.

Type de partenariat	Nombre de partenaires potentiels
Grandes sociétés pharmaceutiques	15
Sociétés pharmaceutiques de taille moyenne	23

Populations de patients avec des types de cancer spécifiques

Cible la population de patients pour les principaux domaines de recherche de Zalale.

Type de cancer	De nouveaux cas annuels aux États-Unis
Cancer du sein	287,850
Cancer de l'ovaire	19,710
Cancer de l'endomètre	66,200

Communauté d'investissement en biotechnologie

Sources d'investissement potentielles pour la recherche et le développement de Zalale.

• Sociétés de capital-risque: 82 investir activement dans l'oncologie
• Investisseurs institutionnels: 156 avec des allocations de portefeuille de biotechnologie
• Cirmités de capital-investissement: 47 avec les sciences de la vie Focus

Évaluation totale du marché adressable: environ 12,4 milliards de dollars de segments de clients potentiels pour Zalalis Pharmaceuticals, Inc. en 2024.

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Zalalis Pharmaceuticals a déclaré des dépenses de R&D de 138,8 millions de dollars. Les dépenses en R&D de la société sont passées de 99,3 millions de dollars en 2021.

Année	Dépenses de R&D	Pourcentage d'augmentation
2021	99,3 millions de dollars	-
2022	138,8 millions de dollars	39.8%

Coûts de gestion des essais cliniques

Zalale a alloué environ 65,4 millions de dollars spécifiquement pour les activités d'essai cliniques en 2022, ce qui représente une partie importante de leurs dépenses totales de R&D.

• Essais de phase 1: fourchette de coûts estimée de 1,4 million de dollars à 2,3 millions de dollars par essai
• Essais de phase 2: plage de coûts estimés de 4,5 millions de dollars à 7,2 millions de dollars par essai
• Essais de phase 3: fourchette de coûts estimée de 11,6 millions de dollars à 18,5 millions de dollars par essai

Protection et entretien de la propriété intellectuelle

Zalalis a dépensé environ 2,7 millions de dollars pour le dépôt, l'entretien et la protection juridique de la propriété intellectuelle des brevets en 2022.

Processus de conformité et d'approbation réglementaires

Activité réglementaire	Coût estimé
Préparation de la soumission de la FDA	750 000 $ - 1,2 million de dollars
Documentation de conformité	$450,000 - $650,000

Recrutement spécialisé des talents scientifiques

La société a investi environ 12,6 millions de dollars d'acquisition et de rétention de talents pour des rôles scientifiques spécialisés en 2022.

• Chercheur principal: rémunération annuelle moyenne de 185 000 $
• Enquêteur principal: compensation annuelle moyenne de 245 000 $
• Spécialiste de la bioinformatique: rémunération annuelle moyenne de 165 000 $

Zalalis Pharmaceuticals, Inc. (ZNTL) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Depuis le quatrième trimestre 2023, Zalalis Pharmaceuticals s'est concentré sur le développement de médicaments commerciaux potentiels en oncologie:

Drogue	Zone thérapeutique	Étape de développement	Projection potentielle des revenus
Zugazolydis (ZG-9291)	Tumeurs solides	Phase 2/3 essais cliniques	75 à 120 millions de dollars de revenus annuels potentiels
Inhibiteur de Zalale HDAC	Thérapeutique du cancer	Étape préclinique	50 à 80 millions de dollars de revenus futurs potentiels

Subventions et financement de recherche

Zalale a obtenu un financement de recherche à partir de plusieurs sources:

• GRANTION NATIONAL INSTITUT DE CANCER (NCI): 2,3 millions de dollars en 2023
• Subvention de recherche du ministère de la Défense: 1,7 million de dollars
• Support de recherche sur la fondation privée: 850 000 $

Accords de partenariat stratégique

Les partenariats stratégiques actuels comprennent:

Partenaire	Type d'accord	Valeur potentielle	Année initiée
Pfizer Inc.	Recherche collaborative	Paiement initial de 25 millions de dollars	2022
Novartis Pharmaceuticals	Partenariat de développement de médicaments	Financement initial de 18,5 millions de dollars	2023

Licence potentielle des candidats au médicament

Potentiel de licence pour les candidats au médicament:

• Zugazolydis (ZG-9291): Valeur de licence estimée 150 à 250 millions de dollars
• Inhibiteur du HDAC: valeur de licence potentielle 80 à 20 millions de dollars
• Composés en oncologie à un stade précoce: 30 à 50 millions de dollars de revenus de licence potentiels

Paiements d'étape provenant de collaborations pharmaceutiques

Structure de paiement d'étape avec partenaires pharmaceutiques:

Type d'étape	Fourchette de paiement potentielle	Événement de déclenchement
Avancement préclinique	5-10 millions de dollars	Études précliniques réussies
Achèvement de phase 1	15-25 millions de dollars	Essais cliniques de phase 1 réussie
Achèvement de phase 2	30 à 50 millions de dollars	Résultats de l'essai de phase 2 positif

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.