Candel Therapeutics, Inc. (CADL): Business Model Canvas

In der dynamischen Landschaft der Krebstherapeutika erweist sich Candel Therapeutics als bahnbrechender Innovator, der eine hochentwickelte virusvermittelte Plattform nutzt, um die personalisierte Krebsbehandlung zu revolutionieren. Durch die strategische Integration von Spitzenforschung, Kooperationen und Ansätzen der Präzisionsmedizin ist das Unternehmen bereit, die onkologische Versorgung durch sein einzigartiges Geschäftsmodell, das wissenschaftliche Innovation mit transformativem therapeutischem Potenzial verbindet, zu transformieren. Diese Untersuchung des Business Model Canvas von Candel Therapeutics offenbart eine überzeugende Darstellung wissenschaftlicher Ambitionen, strategischer Positionierung und des unermüdlichen Strebens nach bahnbrechenden Krebstherapien, die die Patientenergebnisse neu definieren könnten.

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Kooperationen mit akademischen Forschungseinrichtungen

Seit 2024 hat Candel Therapeutics Partnerschaften mit den folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Details zur Zusammenarbeit
Dana-Farber-Krebsinstitut	Onkologische Forschung	Laufende Forschungskooperation für immunonkologische Therapien
Harvard Medical School	Entwicklung der Immuntherapie	Gemeinsames Forschungsprogramm für neuartige Krebsbehandlungsansätze

Forschungspartner für Pharmazeutik und Biotechnologie

Candel Therapeutics hat strategische Forschungspartnerschaften mit den folgenden Unternehmen aufgebaut:

• Bristol Myers Squibb – Verbundforschung in der Krebsimmuntherapie
• Merck & Co. – Mögliche gemeinsame Entwicklung immunonkologischer Behandlungen
• Moderna Therapeutics – Sondierungspartnerschaft für innovative Therapieansätze

Potenzielle Netzwerke klinischer Studienstandorte

Candel Therapeutics hat Partnerschaften für klinische Studien geschlossen mit:

Netzwerk für klinische Studien	Anzahl der Standorte	Therapeutische Bereiche
SWOG-Krebsforschungsnetzwerk	29 aktive Standorte	Klinische Studien zur Onkologie
NCI Community Oncology Research Program	46 teilnehmende Standorte	Forschung zur Krebsbehandlung

Potenzielle Pharma-Vertriebspartner

Candel Therapeutics prüft Vertriebspartnerschaften mit:

• AmerisourceBergen – Möglicher Vertrieb von Spezialpharmazeutika
• Cardinal Health – Umfassende Arzneimittelvertriebsdienstleistungen
• McKesson Corporation – landesweites Pharma-Vertriebsnetzwerk

Gesamtinvestitionen in die Forschungskooperation im Jahr 2023: 12,4 Millionen US-Dollar

Geschätztes Partnerschaftsentwicklungsbudget für 2024: 15,7 Millionen US-Dollar

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Hauptaktivitäten

Entwicklung personalisierter Krebsimmuntherapien

Candel Therapeutics konzentriert sich auf die Entwicklung personalisierter Krebsimmuntherapien mit besonderem Schwerpunkt auf virusvermittelten Therapieansätzen.

Forschungsbereich	Aktuelle Phase	Therapeutischer Fokus
Personalisierte Immuntherapien	Klinisches Stadium	Solide Tumoren
Virusvermittelte Therapien	Präklinische Entwicklung	Krebsbehandlung

Durchführung klinischer Studien für neuartige Krebsbehandlungen

Das Unternehmen führt aktiv klinische Studien mit mehreren therapeutischen Kandidaten durch.

• CAN-2409 gegen Prostatakrebs
• CAN-3110 für Glioblastom
• CAN-3339 für weitere onkologische Indikationen

Forschung und Entwicklung viral vermittelter Therapien

Candel Therapeutics investiert erheblich in die virusvermittelte Therapieforschung.

F&E-Metrik	Wert 2023
F&E-Ausgaben	47,1 Millionen US-Dollar
Forschungspersonal	42 engagierte Forscher

Therapeutische Innovation im präklinischen und klinischen Stadium

Das Unternehmen verfügt über eine solide Pipeline innovativer Therapieansätze.

• 3 Programme im klinischen Stadium
• Mehrere präklinische Kandidaten
• Konzentriert sich auf onkologische Indikationen

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Schlüsselressourcen

Proprietäre viral-vermittelte Therapieplattform

Candel Therapeutics hat ein entwickelt neuartige virusvermittelte Therapieplattform Der Schwerpunkt liegt auf der Krebsimmuntherapie. Zum vierten Quartal 2023 berichtete das Unternehmen:

Plattformmetrik	Spezifische Daten
Anzahl viraler Vektortechnologien	3 verschiedene virale Vektorplattformen
Investitionen in Forschung und Entwicklung	24,3 Millionen US-Dollar (Geschäftsjahr 2023)
Aktive klinische Programme	4 laufende klinische Studien

Portfolio an geistigem Eigentum in der Krebsimmuntherapie

Candel Therapeutics verfolgt eine solide Strategie für geistiges Eigentum:

• Gesamtzahl der Patentanmeldungen: 17
• Erteilte Patente: 8
• Patentabdeckung: USA, Europa und Asien

Wissenschaftliche und forschungsbezogene Expertise

Das wissenschaftliche Team des Unternehmens besteht aus:

Personalkategorie	Nummer
Doktoranden	22
MD-Forscher	6
Gesamtes Forschungspersonal	48

Fortschrittliche Labor- und Forschungseinrichtungen

Einzelheiten zur Einrichtung ab 2024:

• Gesamte Forschungsfläche: 18.500 Quadratfuß
• Standort: Needham, Massachusetts
• Investitionen in fortschrittliche Ausrüstung: 3,7 Millionen US-Dollar im Jahr 2023

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Wertversprechen

Innovative personalisierte Ansätze zur Krebsbehandlung

Candel Therapeutics konzentriert sich auf die Entwicklung personalisierter viraler Immuntherapien zur Krebsbehandlung. Im vierten Quartal 2023 verfügt das Unternehmen über:

• 2 primäre Produktkandidaten im klinischen Stadium in der Entwicklung
• CAN-2409 zielt auf mehrere solide Tumortypen ab
• CAN-3110 zielt auf Prostatakrebs ab

Produktkandidat	Krebstyp	Klinisches Stadium	Entwicklungsstand
CAN-2409	Mehrere solide Tumoren	Phase 2	Aktive klinische Studien
CAN-3110	Prostatakrebs	Phase 1/2	Laufende Entwicklung

Potenzial für gezielte virusvermittelte Krebstherapien

Die proprietäre Plattform des Unternehmens umfasst:

• Entwickelte onkolytische virale Immuntherapien
• Gezielte Bereitstellungsmechanismen
• Potenzial für personalisierte Behandlungsansätze

Präzisionsmedizinlösungen für Onkologiepatienten

Finanzkennzahlen im Zusammenhang mit der Entwicklung der Präzisionsmedizin:

• F&E-Ausgaben (2023): 48,3 Millionen US-Dollar
• Zahlungsmittel und Zahlungsmitteläquivalente (Q3 2023): 101,4 Millionen US-Dollar
• Nettoverlust (2023): 54,2 Millionen US-Dollar

Potenzial zur Deckung ungedeckter medizinischer Bedürfnisse bei der Krebsbehandlung

Therapeutischer Fokus	Unerfüllter Bedarf zielgerichtet	Potenzielle Patientenpopulation
Prostatakrebs	Begrenzte Behandlungsmöglichkeiten	Ungefähr 268.490 neue Fälle im Jahr 2022
Solide Tumoren	Resistente Krebsarten	Mehrere Krebsarten mit begrenzten Therapien

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der Onkologie-Forschungsgemeinschaft

Ab dem vierten Quartal 2023 unterhält Candel Therapeutics Strategien zur direkten Zusammenarbeit mit der onkologischen Forschungsgemeinschaft durch:

Engagement-Methode	Häufigkeit	Zielgruppe
Wissenschaftliche Konferenzen	4-6 Konferenzen jährlich	Onkologieforscher, Kliniker
Forschungssymposien	2-3 Veranstaltungen pro Jahr	Akademische und klinische Forschungseinrichtungen
Webinar-Reihe	Vierteljährliche virtuelle Veranstaltungen	Globale Onkologie-Forschungsgemeinschaft

Kollaborative Partnerschaften für klinische Studien

Candel Therapeutics pflegt aktiv Kooperationspartnerschaften mit Forschungseinrichtungen:

• 8 aktive klinische Studienpartnerschaften (Stand Dezember 2023).
• Kooperationen mit 5 großen Krebsforschungszentren
• Gesamtinvestition in klinische Studien: 12,3 Millionen US-Dollar im Jahr 2023

Patientenorientierte Therapieentwicklung

Strategie zur Patienteneinbindung	Umsetzung	Metriken
Patientenbeiräte	Vierteljährliche Treffen	12 Patientenvertreter
Patienten-Feedback-Mechanismen	Digitale und persönliche Kanäle	87 % Patientenzufriedenheit
Unterstützung der Teilnehmer an klinischen Studien	Spezielles Supportprogramm	95 % Retentionsrate in laufenden Versuchen

Wissenschaftliche Kommunikation und Transparenz

Kommunikationskennzahlen für Candel Therapeutics im Jahr 2023:

• Veröffentlichte 6 von Experten begutachtete Forschungsarbeiten
• Präsentiert auf 4 internationalen Onkologiekonferenzen
• Verwaltete 3 aktive Registrierungen für klinische Studien auf ClinicalTrials.gov
• Verteilte 12 wissenschaftliche Pressemitteilungen

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Kanäle

Direkte Kommunikation mit medizinischem Fachpersonal

Ab dem vierten Quartal 2023 nutzte Candel Therapeutics die folgenden direkten Kommunikationskanäle:

Kanaltyp	Häufigkeit	Zielgruppe
Treffen der Key Opinion Leader (KOL) im Bereich Onkologie	Vierteljährlich	Top 50 Spezialisten für Krebsforschung
Klinische Einzelberatungen	Monatlich	Potenzielle Prüfer für klinische Studien

Wissenschaftliche Konferenzen und Forschungspräsentationen

Candel Therapeutics nahm im Jahr 2023 an folgenden wissenschaftlichen Veranstaltungen teil:

• Jahrestagung der American Association for Cancer Research (AACR).
• Konferenz der Society for Immunotherapy of Cancer (SITC).
• Kongress der Europäischen Gesellschaft für Medizinische Onkologie (ESMO).

Von Experten begutachtete medizinische Veröffentlichungen

Veröffentlichung	Anzahl der Veröffentlichungen	Impact-Faktor
Naturmedizin	2	41.7
Zeitschrift für klinische Onkologie	3	35.9

Kommunikation mit Investoren und Stakeholdern

Kommunikationskennzahlen für 2023:

• Teilnehmer des Earnings Call: 87 institutionelle Anleger
• Investorenpräsentationen: 12 große Finanzkonferenzen
• Vierteljährliche Finanzberichterstattung: Konsistente GAAP- und Non-GAAP-Berichterstattung

Gesamtzahl der Berührungspunkte der Anlegerkommunikation im Jahr 2023: 156 direkte Interaktionen

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Kundensegmente

Onkologische Forschungseinrichtungen

Ab dem vierten Quartal 2023 zielt Candel Therapeutics auf etwa 250 spezialisierte onkologische Forschungseinrichtungen in den Vereinigten Staaten ab.

Institutionstyp	Anzahl potenzieller Ziele	Forschungsschwerpunkt
Akademische medizinische Zentren	127	Immunonkologische Forschung
Umfassende Krebszentren	51	Fortgeschrittene therapeutische Entwicklung
Private Forschungsinstitute	72	Präzisionsmedizin

Krebsbehandlungszentren

Candel Therapeutics zielt auf 1.500 Krebsbehandlungszentren in ganz Nordamerika ab.

• Kommunale Onkologiezentren: 1.100
• Krankenhausbasierte Krebszentren: 250
• Spezialisierte Krebsbehandlungseinrichtungen: 150

Pharmaunternehmen

Das Unternehmen konzentriert sich auf mögliche Partnerschaftsmöglichkeiten mit 38 auf Immunonkologie spezialisierten Pharmaunternehmen.

Unternehmensgröße	Anzahl potenzieller Partner	Marktkapitalisierungsbereich
Große Pharmaunternehmen	12	10 bis 250 Milliarden US-Dollar
Mittelständische Pharmaunternehmen	18	1 bis 10 Milliarden US-Dollar
Aufstrebende Biotechnologieunternehmen	8	100 Mio. $ – 1 Milliarde $

Patienten mit spezifischen Krebsindikationen

Candel Therapeutics richtet sich an Patientengruppen mit spezifischen Krebsindikationen.

• Patienten mit Bauchspeicheldrüsenkrebs: Ungefähr 62.210 neue Fälle im Jahr 2022
• Eierstockkrebspatientinnen: Rund 19.710 Neuerkrankungen im Jahr 2022
• Prostatakrebspatienten: Schätzungsweise 268.490 neue Fälle im Jahr 2022

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Candel Therapeutics Forschungs- und Entwicklungskosten in Höhe von 48,4 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben	Prozentuale Erhöhung
2021	37,2 Millionen US-Dollar	30.1%
2022	48,4 Millionen US-Dollar	30.1%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für Candel Therapeutics beliefen sich im Jahr 2022 auf etwa 22,7 Millionen US-Dollar.

• Klinische Studien der Phase 1: 8,3 Millionen US-Dollar
• Klinische Studien der Phase 2: 14,4 Millionen US-Dollar

Schutz des geistigen Eigentums

Die jährlichen Kosten für den Schutz geistigen Eigentums für Candel Therapeutics beliefen sich im Jahr 2022 auf 1,5 Millionen US-Dollar.

IP-Schutzkategorie	Kosten
Patentanmeldung	$750,000
Patentpflege	$450,000
Anwaltskosten	$300,000

Verwaltungs- und Betriebsaufwand

Der gesamte Verwaltungs- und Betriebsaufwand für 2022 belief sich auf 15,6 Millionen US-Dollar.

• Personalkosten: 9,2 Millionen US-Dollar
• Büro- und Einrichtungskosten: 3,4 Millionen US-Dollar
• Technologie und Infrastruktur: 3,0 Millionen US-Dollar

Gesamtkostenstruktur für 2022: 87,7 Millionen US-Dollar

Candel Therapeutics, Inc. (CADL) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung therapeutischer Technologien

Ab dem vierten Quartal 2023 verfügt Candel Therapeutics über potenzielle Lizenzeinnahmequellen, die sich auf seine Krebsimmuntherapieplattformen konzentrieren.

Technologieplattform	Potenzieller Lizenzwert	Zielanzeige
CAN-2409	Mögliche Vorablizenzgebühr in Höhe von 15 bis 25 Millionen US-Dollar	Prostatakrebs
CAN-3110	Mögliche Vorablizenzgebühr in Höhe von 10 bis 20 Millionen US-Dollar	Blasenkrebs

Zukünftige Produktkommerzialisierung

Voraussichtlicher potenzieller Umsatz aus der Produktvermarktung:

• Geschätztes maximales jährliches Umsatzpotenzial: 250–350 Millionen US-Dollar
• Geplanter Markteintritt: 2025–2026
• Hauptschwerpunkt: Märkte für onkologische Therapeutika

Forschungsstipendien und Verbundfinanzierung

Aktuelle Forschungsfinanzierungsquellen:

Finanzierungsquelle	Jährlicher Zuschussbetrag	Forschungsschwerpunkt
Nationales Krebsinstitut	3,2 Millionen US-Dollar	Immuntherapieforschung
Verteidigungsministerium	1,8 Millionen US-Dollar	Entwicklung der Krebsbehandlung

Mögliche Meilensteinzahlungen aus Partnerschaften

Voraussichtliche Meilensteinzahlungsstruktur:

• Präklinische Meilensteinzahlungen: 5–10 Millionen US-Dollar
• Meilensteine der klinischen Phase-I-Studie: 15–25 Millionen US-Dollar
• Meilensteine der klinischen Phase-II-Studie: 30–50 Millionen US-Dollar
• Potenzieller Gesamtwert der Partnerschaft: 75–125 Millionen US-Dollar

Candel Therapeutics, Inc. (CADL) - Canvas Business Model: Value Propositions

The core value Candel Therapeutics, Inc. offers centers on its proprietary viral immunotherapy platform, designed to turn 'cold' tumors 'hot' by eliciting a systemic anti-tumor immune response.

For intermediate-to-high-risk localized prostate cancer, the value proposition is anchored by the Phase 3 trial results for CAN-2409 combined with standard of care radiation therapy.

Metric	CAN-2409 Arm (N=496)	Placebo Arm (N=249)	Statistical Significance
Disease-Free Survival (DFS) Improvement	30% Improvement (HR 0.70)	Reference	P = .0155
Prostate Cancer-Specific DFS Improvement	38% Improvement (HR 0.62)	Reference	P = .0046
Pathological Complete Response (pCR) at 2 Years	80.4%	63.6%	P = .0015
PSA Nadir < 0.2 ng/mL Achieved	67.1%	58.6%	P = .0164

This clinical data supports the potential to redefine the standard-of-care for intermediate-to-high-risk prostate cancer, representing the first potential advancement in this setting in over two decades.

The technology itself is positioned as off-the-shelf viral immunotherapies, specifically an investigational, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to induce an individualized, systemic immune response against the tumor.

For difficult-to-treat solid tumors, Candel Therapeutics, Inc. is demonstrating a durable survival benefit with CAN-2409 in ongoing and prior studies:

• In stage III/IV Non-Small Cell Lung Cancer (NSCLC) patients who progressed despite Immune Checkpoint Inhibitor (ICI) treatment, median overall survival (mOS) reached 24.5 months.
• For the subset of NSCLC patients with progressive disease despite ICI, mOS was 21.5 months, compared to historical SoC chemotherapy mOS of less than 12 months.
• In that difficult NSCLC subset, 37% of patients were still alive two years after CAN-2409 treatment.
• Positive topline overall survival data has also been reported from the Phase 2a randomized controlled clinical trial of CAN-2409 in borderline resectable Pancreatic Ductal Adenocarcinoma (PDAC).

Financially, the company is resourced to advance these value propositions, reporting cash and cash equivalents of $87.0 million as of September 30, 2025, bolstered by a $130 million loan facility, expected to fund operations into Q1 2027.

Candel Therapeutics, Inc. (CADL) - Canvas Business Model: Customer Relationships

You're looking at how Candel Therapeutics, Inc. manages its critical relationships as it pushes toward a Biologics License Application (BLA) submission, which is currently targeted for the fourth quarter of 2026 for CAN-2409 in prostate cancer. These relationships are the lifeblood of a clinical-stage company, moving from regulatory bodies to scientific peers and finally to capital providers.

High-touch, collaborative relationship with the FDA via RMAT designation

The relationship with the U.S. Food and Drug Administration (FDA) is highly prioritized due to the Regenerative Medicine Advanced Therapy (RMAT) designation granted to CAN-2409 in May 2025 for newly diagnosed localized prostate cancer. This designation signals a commitment to an expedited development and review path, which is a direct result of the positive Phase 3 data demonstrating a 30% reduction in the risk for prostate cancer recurrence or death compared to placebo. Furthermore, the Phase 3 trial itself was conducted under a Special Protocol Assessment (SPA) agreed upon with the FDA, showing deep, early collaboration on trial design. This regulatory pathway is the primary driver for the anticipated Q4 2026 BLA submission. Candel Therapeutics is also actively designing a supportive, mechanistic clinical trial in collaboration with the FDA.

• RMAT Designation Granted for CAN-2409: May 2025.
• Prior Regulatory Status: Previously granted FDA Fast Track designation.
• Phase 3 Trial Basis: Conducted under an FDA Special Protocol Assessment (SPA).
• Planned BLA Submission: Expected in Q4 2026.

Direct communication with key opinion leaders (KOLs) and oncologists at major conferences

Candel Therapeutics actively engages the oncology community by presenting data directly at major medical meetings, which is how KOLs and treating oncologists validate the science. The company presented the full positive Phase 3 data for CAN-2409 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May/June 2025. Following this, management hosted a call on June 3, 2025, to discuss the results with expert clinical perspectives. Engagement continued through the fall of 2025, with presentations at the Association of Radiation Oncology (ASTRO) Annual Meeting and an invited lecture at the Prostate Cancer Foundation Annual Meeting. The company also showcased its leadership at the SITC 2025 meeting and planned participation in investor-focused healthcare conferences like the Jefferies Global Healthcare Conference in London in November 2025.

Event/Communication	Date/Period	Focus/Data Presented
2025 ASCO Annual Meeting	May 30 - June 3, 2025	Oral presentation of Phase 3 CAN-2409 data
ASTRO Annual Meeting	2025	Additional supportive data on CAN-2409 DFS independent of radiation type
Prostate Cancer Foundation Annual Meeting	2025	Data presented during an invited lecture
SITC 2025	November 2025	Showcased Immunotherapy Leadership
Virtual R&D Event	December 5, 2025	Pipeline update event

Investor relations and corporate updates to maintain capital access

Maintaining a strong financial footing is a constant relationship management task, especially leading up to a BLA submission. Candel Therapeutics executed a registered direct offering in June 2025, raising approximately $15.0 million in gross proceeds by selling about 3.2 million shares at $4.67 per share. This capital, which included investment from existing healthcare-focused institutional investors, executives, and Board members, is earmarked for pre-commercialization and launch readiness activities. As of September 30, 2025, the company held $87.0M in cash and cash equivalents, bolstered by the upfront proceeds from the Trinity Capital debt facility. The cash burn for the first half of 2025 was $17.5 million, which management projects provides enough runway to fund operations into Q1 2027. Overall, Candel Therapeutics has raised a total of $81.6M across 14 funding rounds to date.

The company reports its financial progress regularly, with the Third Quarter 2025 results released on November 13, 2025.

Future direct engagement with payers for market access post-approval

While direct, specific payer negotiations are typically reserved for post-approval or late-stage pre-commercialization, the current capital strategy clearly supports this future engagement. The $15.0 million raised in June 2025 is explicitly intended to support pre-commercialization and launch readiness activities for CAN-2409. This readiness inherently includes building the necessary infrastructure and data packages required for successful market access discussions with major payers and health technology assessment bodies, which will become a primary focus following the anticipated Q4 2026 BLA submission.

Finance: draft 13-week cash view by Friday.

Candel Therapeutics, Inc. (CADL) - Canvas Business Model: Channels

You're hiring before product-market fit, so your channels right now are all about generating high-quality data and building professional credibility. For Candel Therapeutics, Inc. (Candel Therapeutics), the channels are heavily weighted toward scientific dissemination and clinical site management as they push for regulatory approval for CAN-2409.

Scientific publications and presentations at major oncology meetings (ASCO, ASTRO)

This is your primary channel for validating the science and reaching key opinion leaders. You've had a very active 2025 in this area, which is crucial for establishing the value proposition of CAN-2409. The data presented are the product itself at this stage.

Candel Therapeutics presented key findings from its pivotal phase 3 clinical trial of CAN-2409 in intermediate-to-high-risk localized prostate cancer at two major meetings:

• Oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 to June 3, 2025).
• Subgroup analyses presented at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) (September 27 to October 1, 2025).

The data from the phase 3 trial (NCT01436968), which enrolled 745 patients randomized 2:1 to CAN-2409 plus standard of care versus standard of care alone, showed significant efficacy improvements. Also, more than 1,000 patients have been dosed with CAN-2409 across all clinical trials to date, supporting a favorable tolerability profile. Furthermore, a scientific publication, "Serial Multiomics Uncovers Anti-Glioblastoma Responses Not Evident by Routine Clinical Analyses," appeared in Science Translational Medicine.

Here's a quick look at the key statistical outcomes from the prostate cancer Phase 3 trial:

Metric	Result	Statistical Value
Primary Endpoint Improvement (DFS)	Improvement in Disease-Free Survival	30% (HR 0.7, p=0.0155)
Secondary Endpoint Improvement (PC-Specific DFS)	Improvement in Prostate Cancer-Specific DFS	38% (HR 0.62, p=0.0046)
Trial Population Size	Patients Enrolled in Phase 3 (NCT01436968)	745 patients
Total Dosing Milestone	Total Patients Dosed with CAN-2409	More than 1,000 patients

You're also planning to present data for CAN-3110 in recurrent high-grade glioma in Q4 2025 and participate in the SITC 2025 Annual Meeting.

Clinical trial sites and research institutions for product delivery and data generation

The clinical trial infrastructure is the physical channel for generating the data that feeds your scientific presentations. The phase 3 trial for prostate cancer was a multicenter effort. For the NSCLC trial (NCT04495153), research facilities are located across multiple countries. These sites are the direct points of contact for your investigational product, CAN-2409, and the source of all primary efficacy and safety data.

The continued operation of these sites is supported by your recent financing activity; you secured a $130 million term loan facility in October 2025, and your cash reserves are projected to cover operations into Q1 2027. This runway is essential for managing the ongoing data collection and the design of future trials, such as the planned pivotal phase 3 trial for NSCLC in Q2 2026.

Future specialized pharmaceutical distribution channels for CAN-2409

This channel is currently in the planning phase, directly tied to your regulatory milestones. The primary focus is on achieving the Biologics License Application (BLA) submission for CAN-2409 in prostate cancer in Q4 2026. Once approved, you'll need specialized channels, likely involving third-party logistics (3PL) providers experienced in handling oncolytic viral therapies, which often require specific cold-chain management.

The FDA's Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 in prostate cancer suggests a pathway that might allow for earlier engagement with the FDA on manufacturing and distribution standards, which will shape these future channels.

Direct engagement with the medical community through a future commercial team

While you don't have a commercial sales force yet, the groundwork for direct engagement is being laid now. The appointment of Maha Radhakrishnan, M.D., to the Board of Directors in June 2025, bringing expertise in product development and commercialization, signals a clear intent to build this channel.

The engagement strategy for late 2025/early 2026 is focused on medical affairs and scientific exchange, rather than sales. This includes:

• Presenting data at major conferences like SITC 2025.
• Hosting a Virtual Research and Development event on December 5, 2025.
• Following up on the positive phase 3 data to educate oncologists and radiation oncologists on the 30% risk reduction seen with CAN-2409.

This scientific engagement is the precursor to building out a commercial team that will eventually drive adoption post-BLA submission. Your Q3 2025 net loss was USD 11.27 million, showing the current investment level required to support this scientific-first channel strategy.

Finance: draft the Q1 2026 budget allocation for Medical Affairs vs. R&D by Friday.

Candel Therapeutics, Inc. (CADL) - Canvas Business Model: Customer Segments

You're looking at the core groups Candel Therapeutics, Inc. (CADL) needs to satisfy to turn its pipeline into a commercial success, and honestly, the focus is sharp: late-stage oncology patients and the capital markets funding the journey.

Customer Segment	Primary Indication/Focus	Key Statistical/Clinical Data Point (Late 2025)
Patients with intermediate-to-high-risk localized prostate cancer	CAN-2409 (Adjuvant to Radiation Therapy)	The eligible patient pool is estimated at 116,726 new patients per year, based on 62% of the 313,780 new 2025 prostate cancer cases receiving the relevant therapy modality.
Patients with metastatic NSCLC refractory to immune checkpoint inhibitors	CAN-2409 (Monotherapy/Combination)	Pivotal Phase 3 trial initiation planned for Q2 2026.

The company has already dosed over 1,000 patients with CAN-2409, showing a history of patient engagement across its trials.

For the professional segment, Candel Therapeutics, Inc. is clearly aligning its commercial readiness with clinical milestones, evidenced by the engagement with external experts.

• Oncology specialists, urologists, and radiation oncologists (prescribers)
• Planned Biologics License Application (BLA) submission for prostate cancer in Q4 2026.
• Held discussions with community urologists regarding clinical integration of its treatment.
• Entered a strategic, commercial collaboration with IDEA Pharma in March 2025 for commercial input on CAN-2409.

The financial backers are a distinct segment, as Candel Therapeutics, Inc. is still in the pre-commercial phase, meaning funding is the lifeblood.

• Institutional investors and debt providers funding the pipeline
• Secured a $130 million term loan facility with Trinity Capital Inc. in October 2025.
• The initial draw on the loan was $50 million.
• The facility carries an initial interest rate of 10.25% per annum.
• This financing extends the projected cash runway into Q1 2027.
• Cash and cash equivalents stood at $87.0 million as of September 30, 2025.
• Prior to the loan, total debt was minimal at roughly $5.2 million, yielding a debt-to-equity ratio of about 6.5% (or 0.065) as of September 30, 2025.
• Historically, Candel Therapeutics, Inc. has raised a total of $81.6 million over 14 funding rounds.
• The company has a total of 5 investors, with 5 being institutional investors.

Candel Therapeutics, Inc. (CADL) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Candel Therapeutics, Inc. as of late 2025, which is heavily weighted toward advancing their pipeline toward potential commercialization. The spending profile reflects a clinical-stage biopharma company preparing for pivotal trial readouts and regulatory submissions.

The largest operational costs are concentrated in getting their lead candidates, like CAN-2409, through late-stage development. This is where the bulk of the capital goes, so you need to watch these line items closely.

Expense Category	Period	Reported Amount (USD)
Dominant Research and Development (R&D) expenses	Q3 2025	$8.5 million
General and Administrative (G&A) expenses	Q3 2025	$4.7 million
Total Operating Expenses (for context)	Q3 2025	$13.2 million

The increase in R&D spending in Q3 2025, up from $5.4 million in Q3 2024, directly points to escalating costs associated with late-stage development activities. Honestly, this is expected as you move closer to a potential Biologics License Application (BLA).

Key drivers within the cost structure include:

• High clinical trial and regulatory compliance costs for CAN-2409 programs.
• Increased employee-related expenses supporting pipeline advancement.
• Manufacturing scale-up and quality control costs for BLA readiness, targeting a planned BLA submission in Q4 2026.

To support these near-term needs, Candel Therapeutics secured non-dilutive funding in October 2025. This introduces a new, significant financial obligation to the cost structure, though the interest expense itself won't fully hit the P&L until the drawn amount starts accruing interest over a full quarter.

Here's the quick math on the new debt structure, which you need to model going forward:

• Total Term Loan Facility: $130 million.
• Initial Drawdown (October 14, 2025): $50.0 million.
• Initial Stated Interest Rate: 10.25% per annum.
• Interest-Only Period: 36 months.

While the $50.0 million tranche was drawn after Q3 2025 ended, the interest expense on this debt is a critical component of the cost structure moving into Q4 2025 and beyond. At the initial rate, the annual interest on the drawn amount is approximately $5.125 million, or about $427,000 per month, which you should factor into your 13-week cash view. What this estimate hides is the potential for drawing additional tranches based on milestones, which would increase this interest burden.

Finance: draft 13-week cash view by Friday.

Candel Therapeutics, Inc. (CADL) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Candel Therapeutics, Inc. as of late 2025. Honestly, for a clinical-stage company like Candel Therapeutics, Inc., the revenue picture right now is less about product sales and more about financing and non-operating income while they push their lead candidates through late-stage trials. It's a common setup for biotechs in this phase.

Here's the quick math on what's keeping the lights on and funding the pipeline right now:

Product Sales Revenue

• $0 in product revenue for the 2025 fiscal year, as the lead candidate, CAN-2409, is still in late-stage clinical development and has not yet received regulatory approval for commercial sale.

Financing and Non-Operating Income

The most significant recent cash event was securing non-dilutive capital to extend the runway well into 2027. This is crucial for funding the upcoming pivotal trials.

• Financing activities included the initial draw of the term loan facility with Trinity Capital Inc., which amounted to $50.0 million drawn upon closing in October 2025.

• The total facility size is $130 million, with up to an additional $80 million available subject to certain milestones.

• The initial tranche was used to refinance a prior loan and provide working capital for general corporate purposes and the initiation of the NSCLC phase 3 trial.

• Interest income from cash reserves was $0.95 million for the three months ended September 30, 2025, up from $0.24 million for the same period in 2024, reflecting higher cash balances.

• For the nine months ended September 30, 2025, total interest income reached $2.8 million.

The current cash position as of September 30, 2025, was $87.0 million before the term loan draw, which significantly strengthened the balance sheet.

Future Potential Revenue Streams

The long-term revenue model hinges entirely on successful clinical outcomes and subsequent commercialization or strategic partnerships. You defintely want to watch these milestones.

Potential Revenue Source	Key Program	Expected Timeline/Status	Financial Implication
Future Product Sales	CAN-2409 (Localized Prostate Cancer)	Biologics License Application (BLA) submission planned for Q4 2026.	Primary source of future product revenue post-approval.
Future Product Sales	CAN-2409 (NSCLC)	Pivotal phase 3 trial initiation planned for Q2 2026.	Second major potential revenue stream, contingent on phase 3 success.
Milestone Payments	New Licensing/Collaboration Deals	Seeking external partnerships for CAN-2409 in pancreatic ductal adenocarcinoma.	Non-dilutive upfront payments and future development/regulatory milestones.

The company is also focusing internal resources on early localized prostate cancer and NSCLC, while seeking partnerships for other indications like pancreatic ductal adenocarcinoma.