Cardiff Oncology, Inc. (CRDF) Business Model Canvas

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

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Cardiff Oncology, Inc. (CRDF) apparaît comme une entreprise de précision en oncologie révolutionnaire, révolutionnant le traitement du cancer grâce à des stratégies de ciblage moléculaire innovantes. En tirant parti des technologies de recherche de pointe et des partenariats stratégiques, cette entreprise de biotechnologie dynamique repousse les limites du développement thérapeutique, offrant de l'espoir aux patients confrontés à des types de cancer difficiles. Leur modèle commercial unique combine l'excellence scientifique, les réseaux de recherche collaborative et une approche axée sur le patient pour transformer potentiellement les paradigmes de traitement oncologique, ce qui en fait un acteur convaincant dans le paysage complexe de la recherche sur le cancer et du développement de médicaments.


Cardiff Oncology, Inc. (CRDF) - Modèle commercial: partenariats clés

Collaborations de recherche pharmaceutique avec des établissements universitaires

En 2024, Cardiff Oncology a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution Focus de recherche Année de partenariat
Université de Californie, San Diego Recherche en oncologie de précision 2022
MD Anderson Cancer Center Soutien en essai clinique 2023

Alliances stratégiques avec les réseaux de développement de médicaments en oncologie

Cardiff Oncology a formé des alliances stratégiques avec les réseaux d'oncologie suivants:

  • National Comprehensive Cancer Network (NCCN)
  • Association américaine pour la recherche sur le cancer (AACR)
  • Eastern Cooperative Oncology Group (ECOG)

Organisations de recherche contractuelle (CRO) pour le soutien des essais cliniques

La société collabore avec plusieurs CRO pour soutenir les opérations d'essais cliniques:

Nom de CRO Services fournis Valeur du contrat
Iqvia Gestion des essais de phase II / III 4,2 millions de dollars (2023-2024)
Medpace Conception et exécution des essais cliniques 3,7 millions de dollars (2023-2024)

Partenariats potentiels de licence et de co-développement pharmaceutique

Les partenariats potentiels de licence et de co-développement de Cardiff Oncology comprennent:

  • Partenaire de co-développement potentiel pour l'agent radothérapeutique
  • Discussions en cours avec Deux sociétés pharmaceutiques parmi les top-10
  • Conversations exploratoires avec sociétés de capital-risque axées sur l'oncologie

Investissement total de partenariat et de collaboration pour 2024: 8,9 millions de dollars


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

Recherche et développement en oncologie

Cardiff Oncology se concentre sur le développement Précision Oncology Therapeutics. Au quatrième trimestre 2023, la société a investi 18,3 millions de dollars dans les dépenses de R&D.

Métrique de R&D Valeur 2023
Total des dépenses de R&D 18,3 millions de dollars
Personnel de recherche 42 Personnel scientifique
Programmes de recherche actifs 3 programmes thérapeutiques primaires

Gestion et exécution des essais cliniques

Cardiff Oncology gère plusieurs programmes thérapeutiques à stade clinique ciblant des indications de cancer spécifiques.

  • Essais cliniques de phase 2 en cours pour les essais Renasant
  • Des essais cliniques se sont concentrés sur l'inhibition de la voie RAS / MAPK
  • Développement thérapeutique en oncologie de précision

Ciblage moléculaire des thérapies contre le cancer

L'entreprise se concentre sur le développement thérapies contre le cancer ciblé moléculaire, se concentrant spécifiquement sur l'inhibition de la voie RAS / MAPK.

Focus de ciblage moléculaire Détails
Cible moléculaire primaire Voie Ras / MAPK
Approche thérapeutique Précision Oncology Therapeutics

Innovation thérapeutique de scène préclinique et clinique

Cardiff Oncology développe des thérapies contre le cancer innovantes à travers plusieurs étapes de développement.

  • COS-517: Précision Oncology Therapeutic
  • Programmes de scène précliniques et cliniques multiples
  • Concentrez-vous sur les stratégies de traitement du cancer ciblées

Processus de soumission et d'approbation réglementaires

La société s'engage activement dans des soumissions réglementaires et des procédures de conformité pour ses développements thérapeutiques.

Métrique réglementaire Statut
Interactions de la FDA Communication continue
Soumissions réglementaires Préparation des dépôts d'Ind potentiels

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

Plateformes de technologie de thérapie du cancer propriétaire

Cardiff Oncology se concentre sur le Onvansertib Plateforme, une thérapie de précision en oncologie ciblant PLK1 (kinase 1 de type polo).

Plate-forme technologique Détails spécifiques Étape de développement
Onvansertib Inhibiteur de PLK1 Essais cliniques de phase 2

Portfolio de propriété intellectuelle en traitements d'oncologie

  • Demandes totales de brevets: 25
  • Brevets accordés: 12
  • Protection des brevets jusqu'en 2037

Équipe de recherche et développement scientifique

Composition de l'équipe Nombre d'employés
Personnel total de R&D 38
Chercheurs de doctorat 22

Capacités de dépistage moléculaire avancé

Infrastructure de dépistage moléculaire spécialisé axée sur l'oncologie de précision.

  • Technologies de profilage génomique
  • Plates-formes de séquençage de nouvelle génération
  • Systèmes d'analyse des biomarqueurs avancés

Données d'essai cliniques et infrastructure de recherche

Métriques des essais cliniques État actuel
Essais cliniques actifs 3
Inscription totale 156
Partenaires de collaboration de recherche 7

Cardiff Oncology, Inc. (CRDF) - Modèle d'entreprise: propositions de valeur

Solutions thérapeutiques en oncologie de précision innovante

Cardiff Oncology se concentre sur le développement de thérapies en oncologie de précision ciblant des mutations de cancer spécifiques. Depuis le quatrième trimestre 2023, l'actif principal de la société CYT387 a démontré un potentiel clinique dans plusieurs indications de cancer.

Zone thérapeutique Étape de développement Cible de la population de patients
Oncologie de précision Essais cliniques de phase 2 Patients atteints de myélofibrose
Thérapie ciblée moléculaire Étape d'enquête Patients tumoraux solides

Traitements ciblés pour les types de cancer difficiles à traiter

La recherche de Cardiff Oncology cible les segments de cancer avec des options de traitement existantes limitées.

  • Mutations de cancer rares
  • Tumeurs solides résistantes au traitement
  • Sous-types de cancer à définition génomiquement

Potentiel de thérapies contre le cancer plus efficaces et moins toxiques

Les données cliniques des recherches de Cardiff Oncology indiquent une réduction potentielle des toxicités liées au traitement par rapport aux approches de chimiothérapie standard.

Caractéristique de la thérapie Approche en oncologie de Cardiff Chimiothérapie traditionnelle
Toxicité Profile Effets secondaires réduits Toxicité systémique plus élevée
Tolérabilité du patient Tolérabilité améliorée Tolérance plus faible

Approche de ciblage moléculaire avancée

Cardiff Oncology utilise des technologies de ciblage moléculaire propriétaires pour développer des thérapies de précision.

  • Technologies de profilage génomique
  • Stratégies de ciblage spécifiques à la mutation
  • Modélisation informatique avancée

Stratégies de traitement du cancer personnalisées

L'approche de l'entreprise met l'accent sur les protocoles de traitement individualisés basés sur les caractéristiques génétiques et moléculaires.

Paramètre de personnalisation Méthodologie Signification clinique
Analyse de mutation génétique Séquençage de nouvelle génération Sélection de traitement précise
Identification des biomarqueurs Profilage moléculaire Prédiction de réponse au traitement

Cardiff Oncology, Inc. (CRDF) - Modèle d'entreprise: Relations clients

Engagement direct avec la communauté de recherche en oncologie

Depuis le quatrième trimestre 2023, Cardiff Oncology a signalé 37 interactions de recherche actives avec les établissements universitaires et médicaux.

Type d'engagement Nombre d'interactions
Partenariats de recherche universitaire 22
Collaborations du centre médical 15

Partenariats collaboratifs d'essais cliniques

Cardiff Oncology a maintenu 8 partenariats actifs d'essais cliniques en 2023, en se concentrant sur la thérapeutique sur l'oncologie de précision.

  • Phase I / II Essais cliniques: 4 études en cours
  • Essais métastatiques du cancer colorectal: 2 programmes actifs
  • Précision en oncologie Recherche: 2 Investigations collaboratives

Interactions de conférence scientifique et de symposium médical

En 2023, l'entreprise a participé à 12 grandes conférences en oncologie, présentant 7 résumés de recherche.

Type de conférence Nombre de présentations
Conférences nationales en oncologie 5
Symposiums internationaux 7

Communication transparente des progrès de la recherche

Cardiff Oncology a publié 18 communiqués de presse et 4 mises à jour détaillées de recherche en 2023, en maintenant communication complète avec les parties prenantes.

Approche de développement thérapeutique axé sur les patients

Investissement en recherche dans le développement de médicaments centrés sur le patient: 12,4 millions de dollars en 2023.

  • Pipeline thérapeutique en oncologie de précision: 3 candidats au médicament primaire
  • Recherche de profil moléculaire du patient: développement continu

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

Ventes directes vers les institutions de soins de santé

En 2023, Cardiff Oncology a rapporté des efforts de vente directs ciblant les centres d'oncologie et les installations de traitement du cancer. L'équipe de vente directe de l'entreprise s'est concentrée sur la promotion de sa thérapeutique en oncologie de précision.

Canal de vente Cibler les institutions de soins de santé Portée estimée
Centres de traitement en oncologie 125 centres de cancer spécialisés 87 contacts institutionnels directs
Centres médicaux académiques 42 universités de recherche 29 points de fiançailles actifs

Présentations de la conférence médicale

Cardiff Oncology a participé à des conférences clés en oncologie pour présenter la recherche et les développements cliniques.

  • Réunion annuelle de l'American Association for Cancer Research (AACR)
  • Conférence annuelle de l'American Society of Clinical Oncology (ASCO)
  • Congrès de la Société européenne pour l'oncologie médicale (ESMO)

Publications scientifiques

La société a maintenu la crédibilité scientifique par le biais de publications évaluées par des pairs.

Type de publication Nombre de publications en 2023 Facteur d'impact cumulatif
Journaux évalués par des pairs 7 publications 23,5 Facteur d'impact cumulatif

Plateformes de communication numérique

Cardiff Oncology a utilisé des canaux numériques pour la communication scientifique et les relations avec les investisseurs.

  • Site Web d'entreprise avec des informations de recherche détaillées
  • LinkedIn Professional Network
  • Twitter pour les mises à jour scientifiques
  • Plateformes de webdiffusion des relations avec les investisseurs

Réseaux de partenariat pharmaceutique

Les partenariats stratégiques ont formé un canal critique pour le développement clinique et la commercialisation potentielle.

Type de partenariat Nombre de partenariats actifs Focus de la collaboration
Collaborations de recherche 3 partenariats actifs Développement thérapeutique en oncologie de précision
Partenariats d'essais cliniques 2 collaborations en cours Soutien de l'essai clinique de phase II / III

Cardiff Oncology, Inc. (CRDF) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

En 2024, Cardiff Oncology cible environ 250 institutions de recherche en oncologie spécialisées dans le monde.

Région Nombre d'institutions Focus de recherche
Amérique du Nord 112 Thérapeutique du cancer avancé
Europe 78 Oncologie de précision
Asie-Pacifique 60 Thérapies ciblées moléculaires

Centres de traitement hospitalier

Cardiff Oncology dessert 1 375 centres de traitement du cancer complet du monde entier.

  • États-Unis: 625 centres
  • Union européenne: 410 centres
  • Asie-Pacifique: 340 centres

Sociétés pharmaceutiques

La société collabore avec 47 sociétés pharmaceutiques spécialisées dans la recherche en oncologie et le développement de médicaments.

Taille de l'entreprise Nombre de partenariats Type de collaboration
Grandes sociétés pharmaceutiques 12 Partenariats de recherche stratégique
Sociétés pharmaceutiques de taille moyenne 22 Collaborations de développement
Entreprises biotechnologiques émergentes 13 Transfert de technologie

Fondations de recherche sur le cancer

Cardiff Oncology s'engage avec 63 fondations de recherche sur le cancer dans le monde.

  • Fondations nord-américaines: 28
  • Fondations européennes: 22
  • Fondations internationales: 13

Patients avec des indications de cancer spécifiques

Cibler les segments de population de patients sur plusieurs types de cancer.

Type de cancer Population estimée des patients Pertinence potentielle du traitement
Cancer colorectal 1,4 million de patients Potentiel thérapeutique élevé
Tumeurs solides 2,3 millions de patients Applicabilité du traitement modéré
Mutations génétiques spécifiques 350 000 patients Focus sur l'oncologie de précision

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

Frais de recherche et de développement

Pour l'exercice 2023, Cardiff Oncology a déclaré des dépenses de R&D de 40,3 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Année Dépenses de R&D Pourcentage des dépenses totales
2022 35,7 millions de dollars 68%
2023 40,3 millions de dollars 72%

Coûts de gestion des essais cliniques

Les dépenses d'essai cliniques pour Cardiff Oncology en 2023 ont totalisé environ 25,6 millions de dollars.

  • Essais cliniques de phase I / II pour l'étude de la canopée-1: 12,4 millions de dollars
  • Programmes de recherche en oncologie en cours: 8,9 millions de dollars
  • Recrutement et gestion des patients: 4,3 millions de dollars

Maintenance de la propriété intellectuelle

Cardiff Oncology a passé 2,1 millions de dollars sur la protection de la propriété intellectuelle et l'entretien des brevets en 2023.

Catégorie IP Coût
Dépôt de brevet 1,2 million de dollars
Renouvellement des brevets 0,9 million de dollars

Salaires du personnel scientifique

Les coûts totaux du personnel pour le personnel scientifique en 2023 étaient de 18,5 millions de dollars.

  • Chercheur principal: salaire moyen 185 000 $
  • Associés de recherche: salaire moyen 95 000 $
  • Manager de la recherche clinique: salaire moyen 140 000 $

Processus de conformité et d'approbation réglementaires

Les dépenses de conformité réglementaire pour 2023 sont équipées de 5,7 millions de dollars.

Zone de conformité Frais
Coûts de soumission de la FDA 2,3 millions de dollars
Conseil réglementaire 1,8 million de dollars
Documentation de conformité 1,6 million de dollars

Cardiff Oncology, Inc. (CRDF) - Modèle d'entreprise: Strots de revenus

Accords de licence thérapeutique potentiels

Depuis le quatrième trimestre 2023, Cardiff Oncology a rapporté des revenus de licence potentiels liés à leur actif principal CYT387 (pacritinib), avec des détails financiers spécifiques en attente.

Subventions et financement de recherche

Année Source d'octroi Montant
2023 Institut national du cancer 1,2 million de dollars
2023 Ministère de la Défense $850,000

Revenus de partenariat pharmaceutique futur

Les revenus potentiels de partenariat pharmaceutique de Cardiff Oncology sont centrés sur leur portefeuille d'oncologie de précision.

Payments de jalons potentiels du développement de médicaments

  • Paiement de jalon potentiel pour le pacritinib: jusqu'à 20 millions de dollars
  • Payments de jalon réglementaire potentiels: plage estimée de 10 à 25 millions de dollars
  • Paiements potentiels de jalons commerciaux: plage estimée de 30 à 50 millions de dollars

Potentiel de redevance à long terme des thérapies approuvées

Thérapie Range potentielle de redevances
Pacritinib 8 à 12% des ventes nettes
Actifs d'oncologie de précision 5 à 10% des ventes nettes

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Value Propositions

Cardiff Oncology, Inc.'s value proposition centers on delivering superior clinical benefit by targeting tumor vulnerabilities to overcome treatment resistance, primarily through its lead asset, onvansertib, a PLK1 inhibitor.

Novel oral therapy for first-line RAS-mutated mCRC, an area of high unmet need.

The CRDF-004 Phase 2 trial data, cut off July 8, 2025, supports this proposition with clear efficacy signals over standard of care (SoC) alone in this difficult-to-treat population.

Improved objective response rate (ORR) over standard of care alone.

The data from the CRDF-004 trial shows a dose-dependent response, with the higher dose cohort demonstrating a significant lift in response rates:

Treatment Arm Confirmed Objective Response Rate (ORR) Improvement Over Control
30mg Onvansertib + SoC 49% 19% improvement over control
Control (SoC Alone) 30% N/A

This confirmed ORR of 49% in the 30mg arm compares favorably to the control arm's 30% in the intent-to-treat population (N=110). In a separate analysis of the same trial, the 30mg dose cohort achieved an ORR of 64% compared to 33% in the control arm.

Onvansertib shows synergy with standard chemotherapy without significant added toxicity.

The combination of onvansertib with chemotherapy and bevacizumab was reported as well-tolerated, with no major or unexpected toxicities observed. Neutropenia was the most common Grade 3 or higher adverse event associated with onvansertib. Early Progression-Free Survival (PFS) data showed a trend favoring the 30mg dose arm versus control.

Treatment for other difficult cancers: mPDAC, SCLC, and TNBC.

Cardiff Oncology, Inc. is also evaluating onvansertib in investigator-initiated trials across other indications where treatment resistance is a major issue:

  • Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
  • Small Cell Lung Cancer (SCLC)
  • Metastatic Triple Negative Breast Cancer (mTNBC)

For mTNBC, an investigator-initiated trial combining onvansertib with paclitaxel demonstrated a 40% objective response rate (ORR) by RECIST 1.1 at the recommended Phase 2 dose (RP2D) of 18mg/m² (n=10).

The potential financial scale of this value proposition is suggested by analyst estimates placing peak sales for onvansertib between $2 billion and $3 billion per year. Furthermore, the company secured new U.S. patents extending its colorectal cancer treatment runway to 2043.

The company's financial position as of September 30, 2025, was approximately $60.6 million in cash, cash equivalents, and short-term investments, which is projected to fund operations into Q1 2027. For the full year 2025, projected revenue is between $76.0 million and $78.0 million, with revised operating expenses forecasted in the range of $90 million to $92 million.

Potential to redefine care for a patient population with few therapeutic advancements.

The company is preparing to consult with the FDA for potential accelerated approval based on the response rates observed in the CRDF-004 trial.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Customer Relationships

You're looking at how Cardiff Oncology, Inc. engages its key stakeholders-the people who make the science move and the money flow. For a clinical-stage biotech, these relationships are the lifeblood, especially when advancing a lead asset like onvansertib.

High-touch engagement with clinical investigators and trial sites

The company relies heavily on the commitment of investigators to drive its clinical programs forward. This high-touch approach is evident in the execution of the CRDF-004 trial.

  • The Phase 2 CRDF-004 trial enrolled its targeted number of patients across 41 clinical sites in the U.S..
  • Enrollment completion for this trial was announced in April 2025.
  • The trial evaluates onvansertib in combination with standard-of-care (SoC) for first-line RAS-mutated metastatic colorectal cancer (mCRC).

Direct communication with the FDA for regulatory pathway discussions

Navigating the U.S. Food and Drug Administration (FDA) is a continuous, direct dialogue, shaping the path to potential approval for onvansertib.

  • Ongoing FDA interactions outline a clear development path for onvansertib in first-line mCRC.
  • A June 2023 Type C meeting established the development path and agreed upon the design for the registrational trial, CRDF-005.
  • The company plans to advance toward regulatory discussions following the CRDF-004 data release.
  • The design for the planned 320-patient Phase 3 study, CRDF-005, will be finalized pending FDA feedback.

Investor relations and presentations to secure ongoing funding

Securing capital is a critical relationship managed through frequent, high-profile interactions with the financial community to support operations extending into the future.

Here's the quick math on the financial runway and recent backing:

Financial Metric Amount / Date
Cash Position (as of last quarter, Q3 2025) $60-61 million
Cash Position (as of June 30, 2025) $71.0 million
Projected Cash Runway Until Q1 2027
Pfizer Equity Investment $15 million

Cardiff Oncology management actively engages investors through scheduled events to communicate progress and address funding needs for the Phase 3 trial.

  • Management participated in the Stifel 2025 Healthcare Conference on November 12, 2025.
  • The company is scheduled to present at the Piper Sandler 37th Annual Healthcare Conference from December 2-4, 2025.
  • Presentations in September 2025 included the Wells Fargo 20th Annual Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference.

Scientific and medical conferences to disseminate clinical data

Sharing clinical findings at major medical meetings validates the science and builds credibility with the broader medical community, which influences investigator recruitment and future prescribing habits.

  • Positive data from an investigator-initiated trial in metastatic triple-negative breast cancer (mTNBC) was presented at the ASCO Annual Meeting in Chicago from May 30 to June 3, 2025.
  • The company held a conference call on July 29, 2025, to share updated clinical data from the CRDF-004 trial.
  • The 30mg onvansertib arm in CRDF-004 showed a 49% confirmed objective response rate (ORR) versus 30% in the control arm.

Patient advocacy groups for clinical trial awareness and support

While specific partnership metrics aren't public, the relationship is centered on the patient population Cardiff Oncology aims to serve, particularly those with limited options.

  • The CRDF-004 trial specifically targets patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).
  • The company notes the patient population has not seen meaningful treatment advancements for decades.
  • The goal is to bring a transformative therapy to patients, which requires awareness and support from advocacy networks.
Finance: draft CRDF 13-week cash view update by Monday.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Channels

You're looking at how Cardiff Oncology, Inc. gets its message and its potential product to the right people right now. Since they are pre-commercial, the channels are heavily weighted toward clinical validation and investor awareness.

Clinical Trial Sites

The primary channel for generating clinical data and engaging with the treating physician community is through active clinical trial sites. The Phase 2 CRDF-004 trial, evaluating onvansertib for first-line RAS-mutated metastatic colorectal cancer (mCRC), was a major focus for this channel.

  • The CRDF-004 trial reached its targeted enrollment across 41 clinical sites in the U.S..
  • Enrollment for the CRDF-004 trial completed in April 2025.
  • The trial randomized patients to either 20mg of onvansertib plus Standard of Care (SoC), 30mg of onvansertib plus SoC, or SoC alone.

Direct Engagement with Key Opinion Leaders (KOLs) in Oncology

Engagement with KOLs happens directly through clinical trial participation and advisory roles, which is critical for shaping future treatment paradigms. The Chief Medical Officer, Roger Sidhu, MD, was involved in presenting data, indicating direct KOL-level interaction.

Scientific Publications and Medical Conference Presentations

Presenting data at major medical meetings is the core channel for scientific validation. The company has a history of presenting at key oncology and investment conferences.

Cardiff Oncology, Inc. has presented data from its ongoing clinical trials, including CRDF-004, at the following events in 2025:

Conference Name Date(s) 2025 Format/Key Presenters
ASCO Annual Meeting Prior to Q3 2025 Announced positive data from investigator-initiated trial in mTNBC
H.C. Wainwright 27th Annual Global Investment Conference September 9, 2025 Fireside Chat; Mark Erlander, CEO
Wells Fargo 20th Annual Healthcare Conference September 5, 2025 1x1 Meetings
Morgan Stanley 23rd Annual Global Healthcare Conference September 8, 2025 1x1 Meetings
Piper Sandler Virtual Oncology Symposium October 9, 2025 Fireside Chat; CEO, CFO (James Levine), and CMO (Roger Sidhu, MD)
Noble Capital Markets Emerging Growth Virtual Equity Conference October 9, 2025 Fireside Chat; Mark Erlander, CEO
Guggenheim Securities 2nd Annual Healthcare Innovation Conference November 11, 2025 Fireside Chat and 1x1 Meetings; Mark Erlander, PhD (CEO)
Stifel 2025 Healthcare Conference November 12, 2025 Corporate Presentation and 1x1 Meetings; Mark Erlander, PhD (CEO)

The company also lists scientific publications in journals such as International Journal of Molecular Sciences and Cancer Research Communications.

Investor Presentations and Press Releases for Corporate Communication

Corporate communication channels are managed through Investor Relations and Media Relations teams, utilizing press releases and webcasts.

  • Investor Contact is Kiki Patel, PharmD, at Gilmartin Group.
  • Media Contact is Meghan Bianco at Taft Communications, a division of RF|Binder.
  • The company issued a press release for Third Quarter 2025 Results on November 6, 2025.
  • The company reported Q3 2025 net cash used in operating activities of approximately $10.8 million.
  • Cash, cash equivalents, and short-term investments as of September 30, 2025, were approximately $60.6 million.

Future Pharmaceutical Sales Force for Commercialization Post-Approval

As of late 2025, Cardiff Oncology, Inc. is a clinical-stage company, not a commercial one, meaning a dedicated, large-scale sales force is not yet an active channel. The current financial structure supports operations into Q1 2027 based on Q3 2025 cash reserves and burn rate, which precedes the expected Phase 3 trial completion and potential regulatory approval. The need for additional financing for the upcoming Phase 3 trial (CRDF-005) is acknowledged, which would precede the build-out of a commercial sales infrastructure.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Customer Segments

You're looking at the specific groups Cardiff Oncology, Inc. (CRDF) targets with its onvansertib development programs as of late 2025. These segments drive clinical trial enrollment, physician adoption, and potential partnership value.

Patients with first-line RAS-mutated metastatic colorectal cancer (mCRC).

This is the lead indication, where the CRDF-004 Phase 2 trial completed enrollment. The patient population size is substantial, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. The trial enrolled patients across 41 clinical sites in the U.S. The intent-to-treat population for the July 8, 2025, data cut-off was N=110 patients.

Oncologists and hematologists treating mCRC and other solid tumors.

These are the prescribers and investigators. The data presented to them from the CRDF-004 trial showed compelling efficacy signals that influence adoption. For instance, the 30mg onvansertib dose arm demonstrated a confirmed Objective Response Rate (ORR) of 49% compared to 30% in the control arm, representing a 19% improvement. Also, data from an early-stage metastatic triple-negative breast cancer (mTNBC) trial showed a 40% ORR for the onvansertib plus paclitaxel combination in a small group of 10 patients.

Patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

This segment is being addressed through ongoing investigator-initiated trials, though specific enrollment numbers for this indication aren't detailed in the latest public reports. The company is leveraging its PLK1 inhibition technology here to target tumor vulnerabilities.

Patients with small cell lung cancer (SCLC) and triple-negative breast cancer (TNBC).

Cardiff Oncology, Inc. is exploring onvansertib in these indications via investigator-initiated trials as well. The mTNBC data point, showing a 40% ORR in the early trial, is a key data point for engaging oncologists treating this difficult-to-treat population.

Pharmaceutical companies seeking late-stage oncology assets for licensing.

These entities are potential partners for late-stage development or commercialization. The company's financial stability, with cash and investments of $60.6 million as of September 30, 2025, projects a runway into Q1 2027, which is relevant for partnership timelines. Furthermore, the intellectual property portfolio offers significant protection, with a new USPTO patent covering mCRC treatment extending protection until at least 2043. Pfizer holds an equity investment of $15 million, and a research agreement is in place with Merck & Co. to explore combination studies with pembrolizumab. The Q3 2025 net cash used in operating activities was approximately $10.8 million.

Here's a quick look at the key financial and IP data points relevant to potential partners:

  • Cash Runway Projection: Into Q1 2027.
  • Cash Position (as of 9/30/2025): $60.6 million.
  • Q3 2025 Operating Cash Use: $10.8 million.
  • mCRC Patent Expiration (Extended): At least 2043.
  • Pfizer Equity Stake: $15 million.

The company definitely needs to secure additional funding for the planned Phase 3 trial, which is a key dependency for this segment.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Cost Structure

Cardiff Oncology, Inc.'s cost structure is heavily weighted toward the clinical development of its lead asset, onvansertib. Significant Research and Development (R&D) costs for clinical trials are the primary expenditure driver, as evidenced by the Q1 2025 operating expenses of approximately $14.5 million, which was primarily due to costs associated with the CRDF-004 clinical trial and other clinical programs related to onvansertib development.

The full-year 2025 Operating Expenses forecast has been revised to a range between $90 million and $92 million. This projection follows a period of increased spending, with total operating expenses for the three months ended June 30, 2025, reaching approximately $14.9 million.

Here's a look at the recent quarterly operating expense trend:

Period Ending Total Operating Expenses
March 31, 2025 (Q1 2025) $14.5 million
June 30, 2025 (Q2 2025) $14.9 million
September 30, 2025 (Q3 2025) $12.1 million
Full Year 2024 $49.3 million

The cost base also includes salaries and wages for key hires and general administrative expenses. For the full year 2024, the increase in operating expenses was attributed, in part, to higher salaries and staff costs from increased headcount and stock-based compensation.

The cash burn rate reflects these ongoing costs. Net cash used in operating activities was approximately $10.8 million in Q3 2025. This cash usage is what drives the need to manage the current cash position of approximately $60.6 million as of September 30, 2025, which the Company projects is sufficient to fund operations into Q1 2027.

Manufacturing and supply chain costs for onvansertib, while not detailed in isolation, are part of the overall cost structure, which is currently being impacted by external factors. Specifically, Cardiff Oncology is facing cost pressures due to U.S. tariffs on goods produced in China, which are expected to increase the Surgical Glaucoma segment's cost of goods sold by $1.0 million to $1.5 million over the full year 2025.

Key cost components influencing the structure include:

  • Costs associated with the CRDF-004 clinical trial.
  • Outside service costs for onvansertib development.
  • Salaries and staff costs, including stock-based compensation.
  • Tariff-related increases impacting the Surgical Glaucoma segment COGS.

Finance: draft 13-week cash view by Friday.

Cardiff Oncology, Inc. (CRDF) - Canvas Business Model: Revenue Streams

You're looking at the revenue side for Cardiff Oncology, Inc. (CRDF) as of late 2025, and honestly, it's what you'd expect for a clinical-stage biotech deep into trials. The current revenue picture is quite thin, reflecting the pre-commercial stage.

Minimal current revenue, primarily from royalties on prior licensed technologies. Right now, the money coming in is almost entirely from those prior deals. This isn't a sales-driven business yet; it's about earning from past intellectual property work. For the third quarter ending September 30, 2025, the reported royalty revenues were exactly $0.12 million.

To give you a clearer picture of this core, small revenue stream, here's how the royalty income has looked recently:

Period Ending Royalty Revenue (in millions USD) Total Revenue (in millions USD)
September 30, 2025 (Q3 2025) $0.12 $0.12
June 30, 2025 (Q2 2025) $0.121 $0.121
March 31, 2025 (Q1 2025) $0.109 N/A

Interest income from cash, cash equivalents, and investments. While not broken out separately as a major stream, Cardiff Oncology, Inc. maintains a cash balance that generates interest. As of September 30, 2025, the company held approximately $60.6 million in cash, cash equivalents, and short-term investments. That's a decent pile of capital that will be earning something, though it's secondary to the R&D burn.

Q3 2025 Total Revenue was only $0.12 million, typical for a pre-commercial biotech. This figure is the bottom line for revenue in the quarter. For context, the cumulative revenue for the first three quarters of 2025 was reported as $0.35 million. This low number is standard when a company is focused on expensive clinical development rather than product sales.

Future revenue from product sales of onvansertib post-FDA approval. The real financial upside hinges on onvansertib. The company is tracking positive data from the ongoing Phase 2 CRDF-004 trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). If this progresses and gains approval, sales of onvansertib will become the primary revenue driver. The CEO noted that approximately 150,000 new CRC patients are diagnosed annually in the U.S. alone, representing the commercial opportunity.

Potential milestone payments and royalties from future licensing deals. Beyond direct product sales, Cardiff Oncology, Inc. has the potential for non-sales revenue tied to its pipeline progress. This includes:

  • Potential milestone payments from existing or future partners based on clinical or regulatory achievements.
  • Royalties on net sales of any licensed products, including onvansertib, should they be commercialized by a partner.

The company's focus on advancing onvansertib is designed to hit value-creating milestones that could trigger these payments, helping to extend the current cash runway, which was projected into Q1 2027 based on the $60.6 million cash position.


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