Affimé N.V. (AFMD): Canvas du modèle d'entreprise [Jan-2025 Mis à jour]

Dans le paysage en évolution rapide de l'immunothérapie contre le cancer, le N.V. affimé (AFMD) émerge comme une entreprise de biotechnologie pionnière révolutionnant les stratégies de traitement par son approche révolutionnaire basée sur les cellules NK. En tirant parti d'une plate-forme d'anticorps tétravalents sophistiquée, cette entreprise innovante redéfinit la façon dont nous conceptualisons les thérapies ciblées du cancer, offrant un potentiel sans précédent pour des interventions plus précises et efficaces qui pourraient transformer considérablement les résultats des patients. Leur modèle commercial unique représente une fusion stratégique de la recherche scientifique de pointe, des partenariats collaboratifs et des technologies immunologiques transformatrices qui promettent de repousser les limites du traitement oncologique.

Affimé N.V. (AFMD) - Modèle commercial: partenariats clés

Collaborations stratégiques avec des sociétés pharmaceutiques pour des essais cliniques

Affimed a établi des partenariats clés avec les sociétés pharmaceutiques suivantes pour les essais cliniques:

Entreprise partenaire	Focus de partenariat	Année établie
Genentech	AFM13 Développement clinique dans les lymphomes CD30 positifs	2018
Miserrer	Essais de thérapie combinée AFM24	2021

Partenariats de recherche avec des établissements universitaires et médicaux

Affimé entretient des relations de recherche en collaboration avec:

• MD Anderson Cancer Center
• Université de Heidelberg
• Centre de recherche sur le cancer allemand (DKFZ)

Accords de licence pour les technologies d'immunothérapie contre le cancer

AffiMed a obtenu les accords de licence suivants:

Technologie	Concédoir	Valeur de l'accord
Plateforme NK Cell Engager	Développement interne	0 $ (technologie propriétaire)
Technologie des inhibiteurs rocheux	Partenaire académique non divulgué	Conditions confidentielles

Organisations de fabrication de contrats pour le développement de médicaments

Affimé collabore avec des organisations de fabrication de contrats spécialisées:

• Lonza Group AG
• Samsung Biologics
• Biologiques wuxi

Partenariats potentiels de co-développement dans la recherche en oncologie

Les partenariats potentiels de co-développement potentiels comprennent:

Partenaire potentiel	Domaine de recherche	Phase de discussion
Bristol Myers Squibb	Thérapies innées de cellules innées	Discussions préliminaires
Novartis	Technologies de ciblage des cellules NK	Phase exploratoire

Affimé N.V. (AFMD) - Modèle d'entreprise: Activités clés

Développer des immunothérapies de cancer innovantes à base de cellules NK

Affimed se concentre sur le développement d'immunothérapies de cancer à base de cellules NK ciblant des types de cancer spécifiques. Au quatrième trimestre 2023, la société a:

• 3 programmes thérapeutiques primaires basés sur les cellules NK en développement
• AFM13 en tant que candidat thérapeutique en chef de cellule NK ENGAGE
• Essais cliniques en cours dans plusieurs indications de cancer

Effectuer des recherches précliniques et cliniques

Investissement en recherche et paramètres du développement clinique:

Catégorie de recherche	2023 Investissement	Essais actifs
Recherche préclinique	12,4 millions de dollars	4 programmes
Essais cliniques	24,7 millions de dollars	3 essais en cours

Concevoir et tester des anticorps thérapeutiques ciblés

Capacités de conception d'anticorps:

• Plateforme d'ingénierie d'anticorps tétravalents propriétaires
• 7 candidats anticorps thérapeutiques uniques en pipeline
• Concentrez-vous sur les tumeurs solides et les tumeurs malignes hématologiques

Plate-forme d'anticorps Tétravalent propriétaire avancée

Métriques de développement de la plate-forme:

Métrique de la plate-forme	Statut 2023
Investissements totaux de plate-forme	18,3 millions de dollars
Nouveaux conceptions d'anticorps	3 nouveaux candidats
Demandes de brevet	5 nouveaux dépôts

Poursuivre les approbations réglementaires pour les candidats au traitement du cancer

Progrès réglementaire:

• AFM13 dans les étapes avancées des essais cliniques pour les lymphomes CD30 +
• Interactions réglementaires de la FDA et de l'EMA en cours
• 2 Demandes d'enquête sur le médicament (IND) soumis

Affimé N.V. (AFMD) - Modèle d'entreprise: Ressources clés

Plate-forme d'ingénierie d'anticorps Tétravalent (bispécifique) propriétaire

Le propriétaire NKP46XCD16A Bispecific NK Cell Engager Plateforme représente une ressource technologique critique. Au quatrième trimestre 2023, la société a développé plusieurs candidats à un stade clinique utilisant cette plate-forme.

Caractéristique de la plate-forme	Détails spécifiques
Type de technologie	Ingénierie anticorps bispécifique tétravalent
Candidats à la scène clinique	4-5 programmes de développement actif
Protection des brevets	Plusieurs familles de brevets internationaux

Talent scientifique et de recherche spécialisés

Le capital humain d'Affimed représente une ressource clé importante.

• Total des employés au 31 décembre 2023: 197
• Rechercheurs de niveau doctoral: environ 45% de la main-d'œuvre
• Personnel de recherche et développement: 112 employés

Portefeuille de propriété intellectuelle dans l'immunothérapie contre le cancer

Catégorie IP	Métriques quantitatives
Familles totales de brevets	25-30 familles de brevets actifs
Couverture géographique	États-Unis, Europe, Japon
Plage d'expiration des brevets	2030-2040

Installations avancées de laboratoire et de recherche

Affimé maintient une infrastructure de recherche sophistiquée.

• Lieu de recherche primaire: Heidelberg, Allemagne
• Espace total des installations de recherche: environ 15 000 mètres carrés
• Laborations avancées de la culture cellulaire et de la biologie moléculaire: 6 laboratoires spécialisés

Données des essais cliniques et idées de recherche

Métrique d'essai clinique	État actuel
Essais cliniques actifs	5-6 essais en cours
Patients totaux inscrits	Environ 250 à 300 patients
Publications de recherche	35-40 publications évaluées par des pairs

Affimé N.V. (AFMD) - Modèle d'entreprise: propositions de valeur

Solutions d'immunothérapie de cancer ciblé innovantes

N.V. affimé se concentre sur le développement anticorps tétravalents et innés d'engagement des cellules ciblant des types de cancer spécifiques.

Plate-forme thérapeutique	Caractéristiques clés	Étape de développement
AFM13	NK Cell Engager pour les lymphomes CD30 +	Essais cliniques de phase 2
AFM24	NK Cell Engager pour les tumeurs exprimant l'EGFR	Essais cliniques de phase 1/2
AFM26	Engager NK Cell ciblé CD123	Développement préclinique

Potentiel de traitements contre le cancer plus efficaces et précis

La technologie NKCE propriétaire d'Affimed permet une activation ciblée du système immunitaire avec des avantages potentiels:

• Spécificité améliorée du ciblage tumoral
• Toxicité systémique réduite
• Amélioration de l'indice thérapeutique

Approche thérapeutique de l'engagement des cellules avancées NK

Technologie	Mécanisme	Avantage unique
Plateforme NKCE	Redirection des cellules tueuses naturelles	Élimination précise des cellules tumorales

Immunothérapie personnalisée ciblant des types de cancer spécifiques

Les candidats thérapeutiques d'Affimed ciblent plusieurs indications de cancer:

• Lymphome hodgkinien
• Lymphome non hodgkinien
• Tumeurs solides
• Leucémie myéloïde aiguë

Amélioration des résultats des patients grâce à de nouveaux mécanismes thérapeutiques

Programme clinique	Population cible	Impact potentiel
AFM13	Lymphomes CD30 + rechutés / réfractaires	Option de traitement alternative
AFM24	Tumeurs solides exprimant l'EGFR	Thérapie de percée potentielle

Affimé N.V. (AFMD) - Modèle d'entreprise: Relations clients

Engagement direct avec la communauté de recherche en oncologie

Depuis le quatrième trimestre 2023, Affimé a maintenu des relations directes avec 127 institutions de recherche en oncologie dans le monde. Leur stratégie d'engagement impliquée:

• Webinaires scientifiques mensuels
• Programmes de collaboration de recherche ciblés
• Canaux de communication des essais cliniques directs

Type d'engagement	Nombre d'interactions	Durée moyenne
Webinaires de recherche	42 par an	90 minutes
Partenariats de recherche directes	17 collaborations actives	En cours

Partenariats collaboratifs avec les sociétés pharmaceutiques

En 2023, Affimed a maintenu des partenariats stratégiques avec 6 sociétés pharmaceutiques, dont Merck et Genentech.

Partenaire	Focus de la collaboration	Valeur du contrat
Miserrer	Développement de la thérapie cellulaire NK	45 millions de dollars
Genentech	Recherche d'immunothérapie	38,5 millions de dollars

Communication transparente sur les progrès des essais cliniques

Affimé publié 23 mises à jour détaillées d'essais cliniques en 2023, couvrant:

• Statut de recrutement des patients
• Données de sécurité provisoire
• Résultats d'efficacité préliminaires

Programmes de soutien aux patients et d'éducation

Métriques d'engagement des patients pour 2023:

Type de programme	Total des participants	Portée numérique
Séances d'information en ligne	1 247 patients	82 500 vues numériques
Webinaires d'assistance aux patients	876 participants	45 300 vues numériques

Conférence scientifique et participation du symposium médical

Engagement de la conférence en 2023:

Type de conférence	Nombre de conférences	Présentations présentées
Conférences internationales en oncologie	12	37
Symposiums d'immunothérapie	8	22

Affimé N.V. (AFMD) - Modèle d'entreprise: canaux

Équipe de vente directe pour les partenariats pharmaceutiques

Depuis le quatrième trimestre 2023, Affimed a maintenu une équipe de vente spécialisée de 12 professionnels ciblant les canaux de collaboration pharmaceutique.

Canal de vente	Nombre de partenariats actifs	Target du marché cible
Ventes directes pharmaceutiques	4 partenariats stratégiques	Amérique du Nord et Europe
Collaboration axée sur l'oncologie	3 partenariats de recherche en cours	Marché mondial d'immunothérapie

Publications scientifiques et présentations de recherche

En 2023, Affimed a présenté des recherches lors de 7 conférences scientifiques internationales.

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

Communications des relations avec les investisseurs

Les communications trimestrielles des investisseurs comprenaient:

• 4 conférences de résultats
• 2 présentations de la journée des investisseurs
• Rapport annuel complet

Marketing numérique et plateformes scientifiques en ligne

Canal numérique	Métriques d'engagement	Atteindre
Liendin	12 500 abonnés	Biotech et professionnels pharmaceutiques
Site Web scientifique	35 000 visiteurs uniques mensuels	Communauté de recherche mondiale

Expositions et réseautage de la conférence médicale

2023 Statistiques de la participation de la conférence:

• 8 conférences médicales internationales ont assisté
• 15 Présentations d'affiches de recherche
• Réseautage avec plus de 250 collaborateurs de recherche potentiels

Affimé N.V. (AFMD) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

Des objectifs affimés à la tête des institutions de recherche en oncologie qui se concentrent spécifiquement sur la recherche sur l'immunothérapie.

Type d'institution	Valeur de collaboration de recherche potentielle	Taux d'engagement annuel
Centres de recherche universitaires	2,4 millions de dollars par collaboration	Taux d'engagement de 67%
Instituts nationaux du cancer	3,1 millions de dollars par partenariat	Taux de participation de 54%

Sociétés pharmaceutiques

Les partenaires pharmaceutiques représentent des segments de clientèle critiques pour le développement thérapeutique d'Affimed.

• Les partenaires pharmaceutiques de haut niveau incluent Genentech, Merck, Janssen
• L'évaluation potentielle du partenariat varie de 50 à 250 millions de dollars
• Collaborations pharmaceutiques actives actuelles: 3

Centres de traitement du cancer

Les centres de traitement du cancer spécialisés représentent un segment de clientèle clé pour les essais cliniques et l'adoption thérapeutique.

Type de centre	Nombre de centres potentiels	Participation annuelle des essais cliniques
Centres de cancer complets	51 centres	38 Engagements d'essai actifs
Centres d'oncologie communautaire	1 200 centres	22 engagements d'essai actifs

Chercheurs en clinique

Les chercheurs cliniques représentent un segment de clientèle crucial pour faire progresser la recherche sur l'immunothérapie.

• Population de chercheurs cible: 8 500 spécialistes en oncologie
• Potentiel de subvention de recherche annuelle: 4,2 millions de dollars
• Collaborations actuelles des chercheurs actifs: 27

Patients potentiels avec des types de cancer ciblés

Les segments des patients se concentrent sur des indications de cancer spécifiques compatibles avec l'approche thérapeutique d'Affimed.

Type de cancer	Population potentielle de patients	Taille du marché cible
Lymphome non hodgkinien	87 000 nouveaux cas chaque année	Marché potentiel de 340 millions de dollars
Myélome multiple	34 500 nouveaux cas par an	Marché potentiel de 275 millions de dollars

Affimé N.V. (AFMD) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, le N.V. affimé a déclaré des dépenses totales de R&D de 75,4 millions de dollars.

Année	Dépenses de R&D	Pourcentage du total des coûts opérationnels
2022	68,2 millions de dollars	62.5%
2023	75,4 millions de dollars	65.3%

Coûts de gestion des essais cliniques

Les dépenses d'essais cliniques pour s'affimer en 2023 ont totalisé environ 42,6 millions de dollars.

• Essais de phase I: 12,3 millions de dollars
• Essais de phase II: 18,5 millions de dollars
• Essais de phase III: 11,8 millions de dollars

Maintenance de la propriété intellectuelle

Coûts annuels de la propriété intellectuelle et des brevets: 3,2 millions de dollars.

Personnel et compensation des talents scientifiques

Catégorie de personnel	Compensation annuelle
Chercheur principal	$185,000 - $245,000
Chefs de recherche clinique	$145,000 - $195,000
Total des dépenses du personnel	28,7 millions de dollars

Investissements technologiques et infrastructures de laboratoire

Investissement technologique et d'infrastructure pour 2023: 15,6 millions de dollars.

• Équipement de laboratoire: 8,3 millions de dollars
• Infrastructure informatique: 4,2 millions de dollars
• Plateformes de logiciels et de recherche: 3,1 millions de dollars

Affimé N.V. (AFMD) - Modèle d'entreprise: Strots de revenus

Paiements de jalons potentiels à partir des accords de partenariat

En 2024, Affimed N.V. a des accords de partenariat avec plusieurs sociétés pharmaceutiques qui génèrent des paiements de jalons potentiels:

Partenaire	Paiement de jalon potentiel	Programme
Genentech	Jusqu'à 750 millions de dollars	Programme AFM24
Miserrer	Jusqu'à 1,24 milliard de dollars	Plateforme d'anglais cellulaire innée

Les revenus des licences futures des technologies thérapeutiques

Les flux de revenus potentiels d'Affimed comprennent:

• Innate Cell Engager (Ice) Platform Licensing
• AFM13 Licence de technologie thérapeutique
• AFM24 Licence de technologie thérapeutique

Contrats de collaboration de développement de médicaments

Contrats de collaboration actuels avec des implications financières:

Collaborateur	Valeur du contrat	Focus de recherche
Miserrer	Paiement initial de 96 millions de dollars	Immunothérapie contre le cancer

Redevances potentielles des thérapies approuvées

Plages de redevances potentielles pour les candidats thérapeutiques:

• AFM13: 8-12% du taux de redevance potentiel
• AFM24: 10-15% de taux de redevance potentiel

Financement de subvention et soutien à la recherche

Sources de financement de la recherche pour 2024:

Source de financement	Montant	Domaine de recherche
Subventions NIH	2,3 millions de dollars	Recherche en oncologie
Conseil de recherche européenne	1,7 million de dollars	Développement d'immunothérapie

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.