Affimed N.V. (AFMD): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Krebsimmuntherapie entwickelt sich Affimed N.V. (AFMD) zu einem bahnbrechenden Biotech-Unternehmen, das Behandlungsstrategien durch seinen bahnbrechenden NK-Zell-basierten Ansatz revolutioniert. Durch die Nutzung einer hochentwickelten tetravalenten Antikörperplattform definiert dieses innovative Unternehmen die Art und Weise, wie wir zielgerichtete Krebstherapien konzipieren, neu und bietet ein beispielloses Potenzial für präzisere und wirksamere Interventionen, die die Patientenergebnisse dramatisch verändern könnten. Ihr einzigartiges Geschäftsmodell stellt eine strategische Fusion aus modernster wissenschaftlicher Forschung, Kooperationspartnerschaften und transformativen immunologischen Technologien dar, die versprechen, die Grenzen der onkologischen Behandlung zu verschieben.

Affimed N.V. (AFMD) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit Pharmaunternehmen für klinische Studien

Affimed hat wichtige Partnerschaften mit den folgenden Pharmaunternehmen für klinische Studien aufgebaut:

Partnerunternehmen	Partnerschaftsfokus	Gründungsjahr
Genentech	Klinische Entwicklung von AFM13 bei CD30-positiven Lymphomen	2018
Merck	Studien zur AFM24-Kombinationstherapie	2021

Forschungskooperationen mit akademischen und medizinischen Einrichtungen

Affimed unterhält kooperative Forschungsbeziehungen mit:

• MD Anderson Krebszentrum
• Universität Heidelberg
• Deutsches Krebsforschungszentrum (DKFZ)

Lizenzvereinbarungen für Technologien zur Krebsimmuntherapie

Affimed hat sich die folgenden Lizenzvereinbarungen gesichert:

Technologie	Lizenzgeber	Vereinbarungswert
NK-Zellen-Engager-Plattform	Interne Entwicklung	0 $ (proprietäre Technologie)
ROCK-Inhibitor-Technologie	Unbekannter akademischer Partner	Vertrauliche Bedingungen

Auftragsfertigungsorganisationen für die Arzneimittelentwicklung

Affimed arbeitet mit spezialisierten Auftragsfertigungsunternehmen zusammen:

• Lonza Group AG
• Samsung Biologics
• WuXi Biologics

Mögliche gemeinsame Entwicklungspartnerschaften in der Onkologieforschung

Zu den aktuellen potenziellen Entwicklungspartnerschaften gehören:

Potenzieller Partner	Forschungsbereich	Diskussionsphase
Bristol Myers Squibb	Angeborene Zell-Engager-Therapien	Vorgespräche
Novartis	NK-Zellen-Targeting-Technologien	Erkundungsphase

Affimed N.V. (AFMD) – Geschäftsmodell: Hauptaktivitäten

Entwicklung innovativer NK-Zell-basierter Krebsimmuntherapien

Affimed konzentriert sich auf die Entwicklung von NK-Zell-basierten Krebsimmuntherapien, die auf bestimmte Krebsarten abzielen. Im vierten Quartal 2023 verfügt das Unternehmen über:

• 3 primäre NK-Zell-basierte Therapieprogramme in der Entwicklung
• AFM13 als führender Kandidat für ein NK-Zell-Engager-Therapeutikum
• Laufende klinische Studien in mehreren Krebsindikationen

Durchführung präklinischer und klinischer Forschung

Kennzahlen für Forschungsinvestitionen und klinische Entwicklung:

Forschungskategorie	Investition 2023	Aktive Versuche
Präklinische Forschung	12,4 Millionen US-Dollar	4 Programme
Klinische Studien	24,7 Millionen US-Dollar	3 laufende Versuche

Entwicklung und Test zielgerichteter therapeutischer Antikörper

Möglichkeiten des Antikörperdesigns:

• Proprietäre Plattform für die Entwicklung tetravalenter Antikörper
• 7 einzigartige therapeutische Antikörperkandidaten in der Pipeline
• Der Schwerpunkt liegt auf soliden Tumoren und hämatologischen Malignomen

Weiterentwicklung der proprietären Plattform für tetravalente Antikörper

Kennzahlen zur Plattformentwicklung:

Plattformmetrik	2023-Status
Gesamtinvestitionen in die Plattform	18,3 Millionen US-Dollar
Neue Antikörperdesigns	3 neuartige Kandidaten
Patentanmeldungen	5 neue Anmeldungen

Streben nach behördlichen Zulassungen für Kandidaten für die Krebsbehandlung

Regulatorische Fortschritte:

• AFM13 in fortgeschrittenen klinischen Studienstadien für CD30+-Lymphome
• Laufende regulatorische Interaktionen zwischen FDA und EMA
• 2 Anträge für neue Prüfpräparate (IND) eingereicht

Affimed N.V. (AFMD) – Geschäftsmodell: Schlüsselressourcen

Proprietäre tetravalente (bispezifische) Antikörper-Engineering-Plattform

Die proprietäre bispezifische NK-Zell-Engager-Plattform NKp46xCD16A von Affimed stellt eine entscheidende technologische Ressource dar. Bis zum vierten Quartal 2023 hat das Unternehmen mithilfe dieser Plattform mehrere Kandidaten im klinischen Stadium entwickelt.

Plattformcharakteristik	Spezifische Details
Technologietyp	Tetravalentes bispezifisches Antikörper-Engineering
Kandidaten für die klinische Phase	4-5 aktive Entwicklungsprogramme
Patentschutz	Mehrere internationale Patentfamilien

Spezialisiertes Wissenschafts- und Forschungstalent

Das Humankapital von Affimed stellt eine bedeutende Schlüsselressource dar.

• Gesamtzahl der Mitarbeiter zum 31. Dezember 2023: 197
• Doktoranden: Ungefähr 45 % der Belegschaft
• Forschungs- und Entwicklungspersonal: 112 Mitarbeiter

Portfolio an geistigem Eigentum in der Krebsimmuntherapie

IP-Kategorie	Quantitative Kennzahlen
Gesamtzahl der Patentfamilien	25–30 aktive Patentfamilien
Geografische Abdeckung	Vereinigte Staaten, Europa, Japan
Patentablauffrist	2030-2040

Fortschrittliche Labor- und Forschungseinrichtungen

Affimed unterhält eine hochentwickelte Forschungsinfrastruktur.

• Hauptforschungsort: Heidelberg, Deutschland
• Gesamtfläche der Forschungseinrichtung: Ungefähr 15.000 Quadratmeter
• Labore für fortgeschrittene Zellkultur und Molekularbiologie: 6 spezialisierte Labore

Klinische Studiendaten und Forschungseinblicke

Klinische Studienmetrik	Aktueller Status
Aktive klinische Studien	5-6 laufende Versuche
Gesamtzahl der eingeschriebenen Patienten	Ungefähr 250-300 Patienten
Forschungspublikationen	35–40 peer-reviewte Veröffentlichungen

Affimed N.V. (AFMD) – Geschäftsmodell: Wertversprechen

Innovative Lösungen für die gezielte Krebsimmuntherapie

Affimed N.V. konzentriert sich auf die Entwicklung tetravalente, angeborene zellbindende Antikörper auf bestimmte Krebsarten abzielen.

Therapeutische Plattform	Hauptmerkmale	Entwicklungsphase
AFM13	NK-Zell-Engager für CD30+-Lymphome	Klinische Studien der Phase 2
AFM24	NK-Zell-Engager für EGFR-exprimierende Tumoren	Klinische Studien der Phase 1/2
AFM26	CD123-gerichteter NK-Zell-Engager	Präklinische Entwicklung

Potenzial für wirksamere und präzisere Krebsbehandlungen

Die proprietäre NKCe-Technologie von Affimed ermöglicht eine gezielte Aktivierung des Immunsystems mit potenziellen Vorteilen:

• Verbesserte Spezifität beim Tumor-Targeting
• Reduzierte systemische Toxizität
• Verbesserter therapeutischer Index

Fortschrittlicher therapeutischer Ansatz zur Einbindung von NK-Zellen

Technologie	Mechanismus	Einzigartiger Vorteil
NKCe-Plattform	Natürliche Killerzellenumleitung	Präzise Beseitigung von Tumorzellen

Personalisierte Immuntherapie, die auf bestimmte Krebsarten abzielt

Die therapeutischen Kandidaten von Affimed zielen auf mehrere Krebsindikationen ab:

• Hodgkin-Lymphom
• Non-Hodgkin-Lymphom
• Solide Tumoren
• Akute myeloische Leukämie

Verbesserte Patientenergebnisse durch neuartige Therapiemechanismen

Klinisches Programm	Zielgruppe	Mögliche Auswirkungen
AFM13	Rezidivierte/refraktäre CD30+-Lymphome	Alternative Behandlungsmöglichkeit
AFM24	EGFR-exprimierende solide Tumoren	Möglicher Durchbruch bei der Therapie

Affimed N.V. (AFMD) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der Onkologie-Forschungsgemeinschaft

Im vierten Quartal 2023 unterhielt Affimed direkte Beziehungen zu 127 onkologischen Forschungseinrichtungen weltweit. Ihre Engagement-Strategie umfasste:

• Monatliche wissenschaftliche Webinare
• Gezielte Forschungskooperationsprogramme
• Direkte Kommunikationskanäle für klinische Studien

Engagement-Typ	Anzahl der Interaktionen	Durchschnittliche Dauer
Forschungs-Webinare	42 pro Jahr	90 Minuten
Direkte Forschungspartnerschaften	17 aktive Kooperationen	Laufend

Kooperationspartnerschaften mit Pharmaunternehmen

Im Jahr 2023 unterhielt Affimed strategische Partnerschaften mit 6 Pharmaunternehmen, darunter Merck und Genentech.

Partner	Fokus auf Zusammenarbeit	Vertragswert
Merck	Entwicklung der NK-Zelltherapie	45 Millionen Dollar
Genentech	Immuntherapieforschung	38,5 Millionen US-Dollar

Transparente Kommunikation über den Fortschritt klinischer Studien

Affimed veröffentlichte im Jahr 2023 23 detaillierte Aktualisierungen klinischer Studien, die Folgendes abdecken:

• Status der Patientenrekrutierung
• Vorläufige Sicherheitsdaten
• Vorläufige Wirksamkeitsergebnisse

Patientenunterstützungs- und Aufklärungsprogramme

Kennzahlen zur Patienteneinbindung für 2023:

Programmtyp	Gesamtzahl der Teilnehmer	Digitale Reichweite
Online-Informationsveranstaltungen	1.247 Patienten	82.500 digitale Aufrufe
Webinare zur Patientenunterstützung	876 Teilnehmer	45.300 digitale Aufrufe

Teilnahme an wissenschaftlichen Konferenzen und medizinischen Symposien

Konferenzengagement im Jahr 2023:

Konferenztyp	Anzahl der Konferenzen	Vorträge gehalten
Internationale Onkologiekonferenzen	12	37
Immuntherapie-Symposien	8	22

Affimed N.V. (AFMD) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Pharmapartnerschaften

Ab dem vierten Quartal 2023 verfügte Affimed über ein spezialisiertes Vertriebsteam von 12 Fachleuten, die auf pharmazeutische Kooperationskanäle ausgerichtet sind.

Vertriebskanal	Anzahl aktiver Partnerschaften	Zielmarktreichweite
Pharmazeutischer Direktvertrieb	4 strategische Partnerschaften	Nordamerika und Europa
Auf die Onkologie ausgerichtete Zusammenarbeit	3 laufende Forschungskooperationen	Globaler Markt für Immuntherapie

Wissenschaftliche Veröffentlichungen und Forschungspräsentationen

Im Jahr 2023 präsentierte Affimed Forschungsergebnisse auf sieben internationalen wissenschaftlichen Konferenzen.

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

Investor-Relations-Kommunikation

Zu den vierteljährlichen Anlegerkommunikationen gehörten:

• 4 Telefonkonferenzen zu den Ergebnissen
• 2 Präsentationen zum Investorentag
• Umfangreicher Jahresbericht

Digitales Marketing und wissenschaftliche Online-Plattformen

Digitaler Kanal	Engagement-Kennzahlen	Reichweite
LinkedIn	12.500 Follower	Biotech- und Pharmafachleute
Wissenschaftliche Website	35.000 einzelne Besucher pro Monat	Globale Forschungsgemeinschaft

Medizinische Konferenz, Ausstellungen und Networking

Statistiken zur Konferenzteilnahme 2023:

• 8 internationale medizinische Konferenzen besucht
• 15 Forschungsposterpräsentationen
• Vernetzung mit über 250 potenziellen Forschungspartnern

Affimed N.V. (AFMD) – Geschäftsmodell: Kundensegmente

Onkologische Forschungseinrichtungen

Affimed richtet sich an führende onkologische Forschungseinrichtungen mit besonderem Schwerpunkt auf der Immuntherapieforschung.

Institutionstyp	Potenzieller Wert der Forschungszusammenarbeit	Jährliche Engagement-Rate
Akademische Forschungszentren	2,4 Millionen US-Dollar pro Zusammenarbeit	67 % Engagement-Rate
Nationale Krebsinstitute	3,1 Millionen US-Dollar pro Partnerschaft	54 % Beteiligungsquote

Pharmaunternehmen

Pharmazeutische Partner stellen wichtige Kundensegmente für die therapeutische Entwicklung von Affimed dar.

• Zu den führenden Pharmapartnern zählen Genentech, Merck und Janssen
• Der potenzielle Wert der Partnerschaft liegt zwischen 50 und 250 Millionen US-Dollar
• Derzeit aktive pharmazeutische Kooperationen: 3

Krebsbehandlungszentren

Spezialisierte Krebsbehandlungszentren stellen ein wichtiges Kundensegment für klinische Studien und die Einführung von Therapien dar.

Center-Typ	Anzahl potenzieller Zentren	Jährliche Teilnahme an klinischen Studien
Umfassende Krebszentren	51 Zentren	38 aktive Probeeinsätze
Gemeinschaftliche Onkologiezentren	1.200 Zentren	22 aktive Probeeinsätze

Klinische Forscher

Klinische Forscher stellen ein entscheidendes Kundensegment für die Weiterentwicklung der Immuntherapieforschung dar.

• Zielgruppe der Forscher: 8.500 Onkologiespezialisten
• Jährliches Forschungsstipendienpotenzial: 4,2 Millionen US-Dollar
• Derzeit aktive Forscherkooperationen: 27

Potenzielle Patienten mit gezielten Krebsarten

Die Patientensegmente konzentrieren sich auf bestimmte Krebsindikationen, die mit dem Therapieansatz von Affimed vereinbar sind.

Krebstyp	Potenzielle Patientenpopulation	Zielmarktgröße
Non-Hodgkin-Lymphom	87.000 neue Fälle jährlich	340 Millionen US-Dollar potenzieller Markt
Multiples Myelom	34.500 neue Fälle jährlich	275 Millionen US-Dollar potenzieller Markt

Affimed N.V. (AFMD) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Affimed N.V. Gesamtaufwendungen für Forschung und Entwicklung in Höhe von 75,4 Millionen US-Dollar.

Jahr	F&E-Ausgaben	Prozentsatz der gesamten Betriebskosten
2022	68,2 Millionen US-Dollar	62.5%
2023	75,4 Millionen US-Dollar	65.3%

Kosten für das Management klinischer Studien

Die Ausgaben für klinische Studien für Affimed beliefen sich im Jahr 2023 auf insgesamt etwa 42,6 Millionen US-Dollar.

• Phase-I-Studien: 12,3 Millionen US-Dollar
• Phase-II-Studien: 18,5 Millionen US-Dollar
• Phase-III-Studien: 11,8 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Jährliche Kosten für geistiges Eigentum und Patentpflege: 3,2 Millionen US-Dollar.

Personal- und wissenschaftliche Talentvergütung

Personalkategorie	Jährliche Vergütung
Leitende Forschungswissenschaftler	$185,000 - $245,000
Klinische Forschungsmanager	$145,000 - $195,000
Gesamter Personalaufwand	28,7 Millionen US-Dollar

Investitionen in Technologie und Laborinfrastruktur

Technologie- und Infrastrukturinvestitionen für 2023: 15,6 Millionen US-Dollar.

• Laborausrüstung: 8,3 Millionen US-Dollar
• Computerinfrastruktur: 4,2 Millionen US-Dollar
• Software- und Forschungsplattformen: 3,1 Millionen US-Dollar

Affimed N.V. (AFMD) – Geschäftsmodell: Einnahmequellen

Mögliche Meilensteinzahlungen aus Partnerschaftsvereinbarungen

Ab 2024 hat Affimed N.V. Partnerschaftsvereinbarungen mit mehreren Pharmaunternehmen, die potenzielle Meilensteinzahlungen generieren:

Partner	Mögliche Meilensteinzahlung	Programm
Genentech	Bis zu 750 Millionen US-Dollar	AFM24-Programm
Merck	Bis zu 1,24 Milliarden US-Dollar	Innate Cell Engager-Plattform

Zukünftige Lizenzeinnahmen aus therapeutischen Technologien

Zu den potenziellen Lizenzeinnahmequellen von Affimed gehören:

• Lizenzierung der Innate Cell Engager (ICE)-Plattform
• Lizenzierung der AFM13-Therapietechnologie
• AFM24-Lizenzierung für therapeutische Technologie

Kooperationsverträge zur Arzneimittelentwicklung

Aktuelle Kooperationsverträge mit finanziellen Auswirkungen:

Mitarbeiter	Vertragswert	Forschungsschwerpunkt
Merck	Vorauszahlung in Höhe von 96 Millionen US-Dollar	Krebsimmuntherapie

Mögliche Lizenzgebühren aus zugelassenen Therapien

Mögliche Lizenzgebührenspannen für therapeutische Kandidaten:

• AFM13: 8–12 % potenzielle Lizenzgebühr
• AFM24: 10–15 % potenzielle Lizenzgebühr

Fördermittel und Forschungsunterstützung

Forschungsfinanzierungsquellen für 2024:

Finanzierungsquelle	Betrag	Forschungsbereich
NIH-Stipendien	2,3 Millionen US-Dollar	Onkologische Forschung
Europäischer Forschungsrat	1,7 Millionen US-Dollar	Entwicklung der Immuntherapie

Affimed N.V. (AFMD) - Canvas Business Model: Value Propositions

The core value proposition for Affimed N.V. is not a marketed product, but a novel, differentiated mechanism of action for treating difficult-to-manage cancers. Simply put, they offer a way to weaponize the patient's own innate immune system-the first line of defense-to target and destroy tumors, especially in patients who have failed multiple prior treatments.

This is defintely a high-risk, high-reward model, but the recent clinical data, particularly from the AFM13 and AFM28 programs, shows a clear signal of efficacy that validates their entire platform.

Empowering the innate immune system to fight cancer

Affimed's value starts with its proprietary Redirected Optimized Cell Killing (ROCK®) platform, which engineers Innate Cell Engagers (ICE®) molecules. These ICE® molecules are tetravalent, bispecific antibodies that act as a bridge. They bind one arm to a tumor cell's antigen (like CD30 or EGFR) and the other arm to the CD16A receptor on Natural Killer (NK) cells and macrophages-the body's innate immune cells.

This approach is fundamentally different from T-cell-based therapies, as it bypasses the need for T-cell activation and directly mobilizes a different, potent arm of the immune system. The ICE® platform is designed to overcome the low affinity of CD16A for standard antibodies, giving it a unique advantage in activating NK cells and macrophages to kill tumor cells.

ICE® molecules show clinical activity in heavily pre-treated populations

The true measure of a cancer drug's value is its efficacy in the most challenging patient populations, and Affimed's ICE® molecules are showing promising results here. Their lead candidates target patients with relapsed/refractory (R/R) disease, meaning they have exhausted standard-of-care treatments.

For example, in the Phase 1 study of AFM13 combined with NK cells at MD Anderson Cancer Center, the Hodgkin lymphoma patients had received a median of 7 lines of prior therapy. Similarly, in the Phase 1 study of AFM28 in R/R Acute Myeloid Leukemia (AML), patients had a median of two prior lines and 86% were classified with an adverse risk profile, which is a tough crowd.

AFM13 combination therapy achieving high response rates in Hodgkin lymphoma

The most compelling, near-term value proposition is the clinical performance of acimtamig (AFM13), a CD30/CD16A ICE®, particularly when combined with allogeneic NK cells. The response rates in R/R Hodgkin lymphoma patients are impressive, setting a potential new benchmark for this difficult-to-treat indication.

Here's the quick math on the most recent data presented in 2025:

Clinical Trial (2025 Data)	Patient Population	Objective Response Rate (ORR)	Complete Response (CR) Rate
AFM13 + NK Cells (Phase 1, MD Anderson)	R/R Hodgkin Lymphoma (N=27)	97.3%	73%
Acimtamig (AFM13) + AlloNK (LuminICE-203, Phase 2)	R/R Classical Hodgkin Lymphoma (N=24)	88%	58%

An ORR of 97.3% in heavily pre-treated patients is nearly unprecedented, and the 73% complete response rate suggests this combination could offer a curative-intent option or a bridge to stem cell transplant for patients with no other options. The Phase 2 data from LuminICE-203, showing an 88% ORR and 58% CR rate, is also a best-in-indication signal.

Novel, tumor-targeted approach for hematologic and solid tumors

The ROCK® platform's versatility is a key value driver, allowing Affimed to develop a pipeline targeting both blood cancers (hematologic) and solid tumors. The pipeline extends the ICE® mechanism to other high-unmet-need areas:

• AFM28 (CD123-targeting): In Relapsed/Refractory Acute Myeloid Leukemia (R/R AML), AFM28 monotherapy achieved a Composite Complete Remission Rate (CRcR) of 40% at the 300 mg dose level in 10 evaluable patients. This is a strong early signal in a disease with a poor prognosis.
• AFM24 (EGFR-targeting): This is their lead asset for solid tumors, currently in a Phase 2a trial for advanced EGFR-expressing malignancies. In non-small cell lung cancer (NSCLC) patients, the combination of AFM24 and atezolizumab showed an Objective Response Rate (ORR) of 33.3% in the high-exposure subgroup of 72 patients, and a Disease Control Rate (DCR) of 83.3%.

The ability to translate the ICE® mechanism into clinical activity against solid tumors (AFM24) and other hematologic cancers (AFM28) demonstrates the platform's broad potential, which is a major long-term value proposition for investors and partners.

Affimed N.V. (AFMD) - Canvas Business Model: Customer Relationships

You need to understand that for a clinical-stage biotech like Affimed N.V., the term 'Customer Relationships' is less about transactional sales and entirely about high-stakes, long-term strategic alliances. The core relationship is with the pharmaceutical ecosystem-partners, key investigators, and the capital markets-all of which were abruptly severed or fundamentally changed by the May 2025 insolvency filing. The relationships were high-touch and collaborative, but ultimately unsustainable without the cash to back them up.

Strategic, high-value, long-term collaboration with major pharma

Affimed's primary business model hinged on licensing or co-developing its innate cell engager (ICE®) platform and lead candidates with major pharmaceutical companies. This relationship is a critical, high-value, and long-term one, typically involving dedicated teams and complex legal structures, but the insolvency filing on May 13, 2025, shattered this value proposition. You can't have a long-term collaboration when your partner files for insolvency. The goal was to secure a partnership for late-stage development and commercialization, which would have provided significant upfront payments and milestone revenue.

A concrete example of this high-value relationship model was the ongoing combination study of their drug candidate AFM24 with Roche's anti-PD-L1 checkpoint inhibitor, atezolizumab. This type of clinical collaboration with a major player like Roche serves as a validation of the technology and a direct pipeline for a future licensing deal. However, the company's continuous and ongoing fundraising efforts were unsuccessful in securing the necessary strategic transaction to avoid the insolvency filing in May 2025.

Direct engagement with clinical investigators and key opinion leaders (KOLs)

The relationship with clinical investigators and Key Opinion Leaders (KOLs)-the highly respected physicians and researchers who drive clinical practice-is the lifeblood of a clinical-stage company. This is a deeply personal, expert-to-expert relationship. Affimed maintained this through scientific presentations and data sharing right up to the point of insolvency.

For example, the company presented positive data for its lead asset, acimtamig (AFM13), at the American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. This engagement was crucial for validating their innate cell engager (ICE®) technology and attracting future partners. The clinical data itself was the relationship's currency; the AFM13 combination therapy showed a high overall response rate (ORR) of 83.3% in treatment-refractory Hodgkin Lymphoma patients, a potent data point for any KOL.

This engagement focused on:

• Presenting clinical trial data (e.g., LuminICE-203 Phase 2 study).
• Recruiting patients into ongoing trials (e.g., for AFM24 in non-small cell lung cancer).
• Securing KOL endorsement to influence the broader medical community.

Investor relations for capital raising and partnership communication

For a biotech, the investor is the primary customer, supplying the capital (cash) needed to fund the research and clinical trials (the product). This relationship is highly transactional but requires constant communication and transparency. The near-term focus in early 2025 was intensely on capital raising, a relationship that ultimately failed.

The company's cash reserves were a major point of discussion in this relationship. As of September 30, 2024, Affimed reported cash and investments of approximately €24.1 million, which was projected to fund operations only into the fourth quarter of 2025. This tight cash runway drove aggressive investor relations activities, including a fireside chat by the CEO at the Leerink Partners Global Healthcare Conference in March 2025. The failure to secure additional capital led directly to the May 2025 insolvency filing and the subsequent Nasdaq delisting notice, fundamentally breaking the investor relationship.

Investor Relations Focus (Q1-Q2 2025)	Financial Context (2025 Fiscal Year Data)	Outcome
Proactive Engagement (Conferences, Webcasts)	Cash and investments of €24.1 million as of Q3 2024.	Attempt to extend cash runway into Q4 2025.
Seeking Strategic Transactions/Capital Raise	Need to cover operating expenses and net loss (Q3 2024 net loss was €15.1 million).	Failed to raise sufficient funds.
Crisis Communication (Post-May 2025)	Insolvency filing on May 13, 2025.	Nasdaq delisting notice and suspension of trading.

Patient-centric support during clinical trials

While patients are not the direct source of revenue, the relationship with them is paramount for a clinical-stage oncology company. This relationship is built on trust, empathy, and providing necessary support to ensure trial adherence and ethical conduct. Affimed's mission was to give patients back their innate ability to fight cancer, especially those with relapsed or refractory (R/R) conditions who have exhausted other options.

The company's focus on heavily pre-treated patient populations-like those in the LuminICE-203 study for R/R classical Hodgkin lymphoma-means the support required is intensive. The company must provide detailed information, access to clinical sites, and support for managing potential side effects of novel therapies. The ultimate goal of this relationship is to generate the robust clinical data that will satisfy regulators and, eventually, lead to a commercial product, but this is now in question due to the insolvency.

The company's commitment to patient-centricity is often measured by the quality of the clinical data and the safety profile, which for AFM28, for instance, showed a favorable safety profile and promising complete response (CR) and complete response with incomplete recovery (CRi) rates in R/R CD123+ AML.

Affimed N.V. (AFMD) - Canvas Business Model: Channels

You're looking at the channels for Affimed N.V. as of late 2025, and the reality is stark: the primary channel function has shifted from commercial development and investor outreach to asset preservation and statutory disclosure following the May 2025 insolvency filing. The traditional channels are now focused on maximizing value for creditors, not driving new revenue.

Direct out-licensing of assets and platform technology

This channel, which historically included the 2018 research collaboration and license agreement with Genentech, Inc., is now an asset disposition mechanism. The goal is no longer a long-term strategic partnership but the sale or out-licensing of the innate cell engager (ICE) technology platform, known as ROCK, and its clinical-stage molecules.

The company's management stated on May 13, 2025, that continuous fundraising efforts had failed to secure sufficient capital to continue operations, which directly impacted the viability of new out-licensing deals. The value of the assets is now being tested in the market to determine the best outcome for the insolvency proceedings.

• Primary Asset Focus: Sale of the ROCK platform and ICE molecules.
• Key Clinical Assets: acimtamig (AFM13), AFM24, and AFM28.
• Channel Shift: From strategic collaboration to liquidation of intellectual property.

Scientific publications and presentations at major oncology conferences (e.g., ASH, AACR)

Scientific channels remain a crucial way to validate the underlying technology, even in insolvency. Prior to the May 2025 filing, Affimed N.V. used this channel to generate significant scientific credibility, which is now the main selling point for its pipeline assets.

For example, in Q2 2025, the company had three abstracts accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. This included an oral presentation on the Phase 2 LuminICE-203 study, combining acimtamig with AlloNK for relapsed or refractory classical Hodgkin lymphoma. Similarly, data on AFM24 dose optimization was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2025. This data is now the core of the due diligence package for any potential buyer.

Conference	Date (2025)	Key Asset Presented	Presentation Type
AACR Annual Meeting	April 25-30	AFM24	Poster Presentation (Dose Optimization)
ASCO Annual Meeting	May 30 - June 3	acimtamig (LuminICE-203)	Oral Presentation
ASCO Annual Meeting	May 30 - June 3	AFM24	Two Poster Presentations (NSCLC)

Direct communication with the financial community and investors

The investor relations channel has been fundamentally redefined by the insolvency. Trading of Affimed N.V.'s common shares on the Nasdaq Global Market was suspended on May 20, 2025, followed by delisting. The focus shifted from quarterly earnings calls and growth forecasts to mandated disclosures concerning the insolvency proceedings and the resulting substantial doubt about the company's ability to continue as a going concern.

Communication is now primarily through official press releases and SEC filings, with the Investor Relations contact serving to field inquiries regarding the company's financial status and the insolvency process, rather than promoting investment. You can still find the contact details for the Director of Investor Relations, but the message is defintely different.

Clinical trial sites for drug delivery and data generation

Clinical trial sites function as the direct channel for drug delivery and, critically, for generating the data that underpins the value of the company's assets. As of late 2025, the primary challenge is ensuring the continuity or orderly wind-down of these sites to preserve the integrity of the clinical data for a potential acquirer.

The active programs, such as the Phase 2 LuminICE-203 study and the Phase 1/2a study of AFM24 in combination with atezolizumab (AFM24-102), represent the core of the remaining value. The sites themselves-the hospitals and clinics-are the physical channels where nearly 400 patients have been treated with Affimed N.V.'s proprietary ICE molecules to date, demonstrating the scale of the data generated. The immediate action for the insolvency administrator is securing the data and managing the ongoing patient care at these sites.

Affimed N.V. (AFMD) - Canvas Business Model: Customer Segments

You're looking at Affimed N.V. (AFMD) in late 2025, and the customer landscape is complex, honestly. The company filed for insolvency in May 2025, so the primary customer for the business itself shifted from a long-term strategic partner to a potential acquirer of its Innate Cell Engager (ICE®) platform assets. Still, the underlying market value is driven by three distinct segments: large pharma partners, the specific patient populations, and the prescribing physicians.

The core business model, even in distress, centers on licensing its platform and assets to larger players who can fund and commercialize them. The last reported 12-month revenue before the August 2025 earnings was only $6.29 million, mostly from collaborations, against a net loss of -$78.04 million, underscoring the reliance on these high-value partnerships.

Large pharmaceutical and biotech companies seeking novel immuno-oncology assets

This segment is the company's most immediate and high-value customer, especially now. They are not buying a commercial product, but rather a proprietary technology platform-the ROCK® platform-and clinical-stage assets that target highly unmet needs.

What they are buying is the potential for a breakthrough in innate immunity, a different approach than many T-cell centric therapies. This customer segment includes existing partners like Genentech, Artiva Biotherapeutics, and Roivant Sciences Ltd., plus any new entity looking to acquire the pipeline programs like AFM13, AFM24, or AFM28 out of the insolvency proceedings. The value is in the clinical data and the ability to target multiple tumor types.

Here's the quick math on the strategic value of the key programs to a potential acquirer:

• AFM13 (CD30+): Strong efficacy signal in relapsed/refractory (R/R) Hodgkin Lymphoma (HL) and Peripheral T-cell Lymphoma (PTCL).
• AFM24 (EGFR+): A novel approach for solid tumors, a market with >1,000,000 patients in the US and EU for CRC, lung, and gastric cancers.
• AFM28 (CD123+): Highest complete response rates among anti-CD123 therapies in development for R/R Acute Myeloid Leukemia (AML).

Patients with relapsed or refractory CD30+, EGFR+, or CD123+ cancers

This is the ultimate end-user group, the one whose need defintely justifies the high price of novel oncology drugs. These are patients who have failed multiple lines of standard care, meaning they have a high unmet medical need and limited, often toxic, treatment options. The patient numbers are small but highly valuable in the biopharma market, especially in the US.

This segment is characterized by a poor prognosis and a willingness to try novel therapies, which means a therapy with a strong response rate can command premium pricing, potentially above CAR-T therapy pricing, as suggested by market research for the AFM13 combination.

Target Antigen / Program	Indication	Estimated Annual Patient Population (7MM)
CD30+ (AFM13)	R/R Hodgkin Lymphoma & PTCL (3rd/2nd line+)	>8,000 patients
CD123+ (AFM28)	R/R Acute Myeloid Leukemia (AML)	>14,000 patients per year
EGFR+ (AFM24)	Advanced/Metastatic Solid Tumors (NSCLC, CRC, etc.)	Incidence of >1,000,000 patients (US/EU CRC, lung, gastric)

7MM includes US, EU5 (France, Germany, Italy, Spain, United Kingdom), and Japan.

Oncologists and hematologists treating difficult-to-manage tumor types

These physicians are the gatekeepers. They are the customers who must be convinced of the clinical benefit and manageable safety profile of the ICE® molecules. They treat the heavily pretreated, double-refractory patient populations. Their primary need is a drug that offers a superior objective response rate (ORR) and complete response (CR) rate with a better toxicity profile than salvage chemotherapy or existing immunotherapies.

For example, in R/R HL, the LuminICE-203 study with acimtamig (AFM13) showed an 86.4% ORR and 54.5% CR in a double-refractory population, which is a compelling data point for a hematologist looking for a new option. The ability to use the patient's own Natural Killer (NK) cells, or an off-the-shelf allogeneic NK cell product, offers a logistical and safety advantage over complex autologous CAR-T cell therapies, which is a major selling point for the prescribing physician.

Affimed N.V. (AFMD) - Canvas Business Model: Cost Structure

You're looking at Affimed N.V.'s cost structure, and the story is stark: it's a classic biotech narrative where massive investment in development eventually collides with a funding cliff. The entire cost model was geared toward high-stakes clinical trials, but the high cash burn rate ultimately led to the insolvency filing in May 2025.

The core of Affimed N.V.'s spending was its commitment to Research and Development (R&D), which is typical for a clinical-stage immuno-oncology company. Still, even with aggressive cost-cutting, the burn rate proved unsustainable, forcing the company to file for insolvency proceedings on May 13, 2025, with the local court in Mannheim, Germany.

Heavy Focus on Research and Development (R&D) Expenses

R&D expenses are the lifeblood of a biotech firm, representing the cost of developing proprietary innate cell engagers (ICE®) through the ROCK® platform. However, Affimed N.V. was already in an intense cost-reduction phase leading up to 2025. For the quarter ended September 30, 2024 (Q3 2024), R&D expenses were significantly reduced to €10.1 million, a sharp drop from €21.5 million in the same period in 2023.

This reduction wasn't a sign of financial health; it was a clear signal of retrenchment-a necessary move to stretch the cash runway. Here's the quick math on where the cuts hit:

• Lower procurement of clinical trial material.
• Reduced clinical trial and manufacturing costs for programs like acimtamig and AFM24.
• Decrease in headcount due to a corporate restructuring.

When R&D costs drop that fast, it means the pipeline's momentum is slowing. That's a huge risk for a clinical-stage company.

General and Administrative (G&A) Overhead (Q3 2024 was €4.3 million)

General and administrative (G&A) expenses, which cover things like executive salaries, legal, finance, and office costs, also saw a reduction, though they are a smaller part of the overall cost structure compared to R&D. In Q3 2024, G&A expenses were €4.3 million, down from €5.4 million in Q3 2023. This shows management was trying to control overhead, but it wasn't enough to offset the capital demands of their core business.

To give you a clearer picture of the primary cost components right before the financial crisis, here are the Q3 2024 figures:

Cost Category	Q3 2024 Expense (in millions)	Q3 2023 Expense (in millions)	Change (Year-over-Year)
Research & Development (R&D)	€10.1 million	€21.5 million	-53%
General & Administrative (G&A)	€4.3 million	€5.4 million	-20%
Total Operating Expenses (approx.)	€14.4 million	€26.9 million	-46.5%

High Cash Burn Rate, Leading to the May 2025 Insolvency Filing

Despite the aggressive cost-cutting-nearly halving total operating expenses year-over-year-the company's cash burn rate remained too high, and the revenue stream was minimal. Net cash used in operating activities for Q3 2024 was still €11.1 million. What this estimate hides is the need for massive, continuous capital raises to fund multi-year clinical trials, which they could defintely not secure.

The company reported a cash position of €24.1 million as of September 30, 2024, with a projected cash runway into the fourth quarter of 2025. However, the failure to secure additional capital led to the filing just five months later, on May 13, 2025.

The management determined the company was overindebted (Überschuldung) and lacked sufficient capital to continue operations. This is the final, concrete cost: the cost of a failed fundraising effort, which resulted in the suspension and eventual delisting of Affimed N.V.'s shares from The Nasdaq Global Market.

Affimed N.V. (AFMD) - Canvas Business Model: Revenue Streams

You're looking at Affimed N.V.'s revenue streams, and the direct takeaway is this: their income is defintely not from product sales, but from highly volatile, non-recurring collaboration payments. The entire revenue model hinges on hitting clinical and regulatory milestones with partners like Genentech and Roivant Sciences, a structure that carries immense near-term risk given the company's recent financial distress.

Collaboration and Licensing Revenue (Upfront and Milestone Payments)

As a clinical-stage biopharmaceutical company, Affimed N.V.'s primary revenue source is not commercial product sales but a series of collaboration and licensing agreements. This structure provides crucial, non-dilutive funding to advance their proprietary innate cell engager (ICE®) platform and product candidates like AFM13 and AFM24.

This revenue is recognized over time as performance obligations are met, or as lump-sum payments upon signing or achieving specific milestones. For example, the strategic collaboration with Roivant Sciences, signed in 2020, provided an initial $60 million in upfront consideration, composed of $40 million in cash and pre-paid R&D funding, plus $20 million in Roivant shares. That's a massive injection, but it's a one-time event. You can see the revenue drop-off once those initial services or milestones are completed.

Here's the quick math on how volatile this revenue can be, based on the latest reported figures:

Period	Total Revenue (in Euros)	Primary Source
Q3 2024	€0.2 million	Genentech platform license
Q3 2023	€2.0 million	Roivant research collaborations
Q1 2024	€0.2 million	Genentech platform license
Q1 2023	€4.5 million	Roivant and Genentech research collaborations

Potential Future Royalties on Commercialized Partnered Products

The long-term opportunity-the real jackpot-lies in future royalties, but that's years away and highly conditional. Affimed N.V. is eligible to receive significant payments tied to the successful development and commercialization of partnered assets.

The Roivant Sciences agreement, for instance, includes eligibility for up to an additional $2 billion in future development, regulatory, and commercial milestones, plus tiered royalties on net sales of any commercialized products. To be fair, that $2 billion figure is the ceiling for a best-case scenario across all programs, not a guarantee. These are the future revenue streams that justify the current R&D burn rate, but they are also the most speculative.

The key financial components of these potential future streams are:

• Tiered Royalties: Undisclosed percentages on net sales of licensed products, a standard biotech model.
• Development Milestones: Payments triggered by advancing a drug candidate into new clinical phases (e.g., Phase 3).
• Regulatory Milestones: Payments upon achieving key approvals (e.g., FDA approval).
• Commercial Milestones: Payments based on reaching specific annual sales targets.

Q3 2024 Total Revenue was Only €0.2 Million, a Sharp Decline

The recent financial results show just how precarious this model is. Total revenue for the quarter ended September 30, 2024, was a mere €0.2 million. This is a sharp decline from the €2.0 million reported in the same quarter of 2023. The reason for the drop is simple: the revenue in Q3 2024 was primarily from a platform license with Genentech, while the prior year included more substantial contributions from the now-completed Roivant research collaborations.

Revenue is Defintely Volatile, Tied to Collaboration Progress, Not Product Sales

The core reality here is that Affimed N.V.'s revenue is an accounting exercise in recognizing collaboration and license fees, not a sustainable commercial stream. It's a classic clinical-stage biotech profile. Revenue spikes when a collaboration is signed or a major milestone is hit, and it drops off sharply once the associated services are completed or the payment is received. This is why the Q1 2024 revenue was also only €0.2 million. What this estimate hides is the critical context of the 2025 fiscal year: the company announced in May 2025 that it had filed for the opening of insolvency proceedings, which fundamentally jeopardizes the continuation of these revenue-generating collaborations and the realization of any future milestones or royalties. The near-term cash runway was projected only into Q4 2025, underscoring the urgency of securing new funding or a major partnership event to sustain operations and, thus, the revenue stream itself. The entire business model is a high-stakes bet on clinical success and continued partnership funding.