HCW Biologics Inc. (HCWB): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la biotechnologie en évolution, HCW Biologics Inc. (HCWB) apparaît comme une force pionnière, transformant le paradigme de la recherche immunothérapeutique avec son approche révolutionnaire du traitement ciblé de la maladie. En tirant stratégiquement une toile de modèle commerciale robuste qui intègre des technologies innovantes, des partenariats stratégiques et des capacités de recherche de pointe, HCWB est sur le point de révolutionner des solutions thérapeutiques dans les domaines d'oncologie et de maladies infectieuses. Leur plate-forme unique promet non seulement des avancées progressives, mais aussi des percées transformatrices qui pourraient redéfinir la façon dont les défis médicaux complexes sont abordés, ce qui en fait une entité convaincante pour les chercheurs, les investisseurs et les professionnels de la santé.

HCW Biologics Inc. (HCWB) - Modèle commercial: partenariats clés

Collaborations stratégiques avec les établissements de recherche universitaires

HCW Biologics a établi des partenariats avec les établissements de recherche universitaires suivants:

Institution	Focus de recherche	Année de collaboration
Université de Miami	Recherche d'immunothérapie	2022
Université Johns Hopkins	Développement du traitement du cancer	2021

Partenaires de développement pharmaceutique

Les principaux partenariats de développement pharmaceutique comprennent:

• Pfizer Inc. - Programme de découverte de médicaments collaboratifs
• Bristol Myers Squibb - Alliance de recherche sur immunothérapie

Organisations de recherche contractuelle (CROS)

Nom de CRO	Portée du service	Valeur du contrat
Iqvia	Gestion des essais cliniques	3,2 millions de dollars
Medpace	Soutien de la recherche préclinique	2,7 millions de dollars

Investisseurs biopharmatiques potentiels et sociétés de capital-risque

Partenaires d'investissement identifiés:

• Versant Ventures - Engagement d'investissement de 12 millions de dollars
• Conseillers orbimés - Financement potentiel de 8,5 millions de dollars
• Fidelity Investments - Biotechnology Venture Portfolio

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: Activités clés

Développer de nouvelles technologies immunothérapeutiques

Les biologiques HCW se concentrent sur le développement de technologies immunothérapeutiques innovantes ciblant les maladies complexes. Depuis 2024, la société a:

• 4 plates-formes immunothérapeutiques primaires en développement actif
• 2 Drugs de plomb aux stades précliniques et cliniques
• Investissement de 12,3 millions de dollars en R&D pour de nouvelles technologies thérapeutiques

Plate-forme technologique	Étape de développement	Indication cible
HCW9218	Essai clinique de phase 1/2	Tumeurs solides
HCW9302	Préclinique	Immunothérapie contre le cancer

Effectuer des recherches précliniques et cliniques

Les activités de recherche impliquent une étude scientifique complète et une validation des approches thérapeutiques.

• Équipe de recherche de 24 scientifiques et chercheurs
• 3 protocoles d'essais cliniques actifs en 2024
• Dépenses de recherche annuelles: 8,7 millions de dollars

Concevoir des plateformes de livraison de médicaments propriétaires

HCW Biologics est spécialisé dans les mécanismes innovants de l'administration de médicaments.

Plate-forme de livraison	Caractéristiques uniques	Applications potentielles
Plate-forme stable	Ciblage cellulaire amélioré	Oncologie, maladies infectieuses
Plate-forme de garniture	Amélioration de la modulation immunitaire	Immunothérapie

Avanouissement des solutions de traitement des maladies infectieuses et infectieuses

Focus stratégique sur le développement d'interventions thérapeutiques ciblées.

• 2 essais cliniques de traitement du cancer en cours
• 1 programme de recherche sur les maladies infectieuses
• Portefeuille de brevets: 7 Brevets accordés en 2024

Domaine de recherche	Programmes actifs	Allocation de financement
Oncologie	3 programmes	6,5 millions de dollars
Maladies infectieuses	2 programmes	3,2 millions de dollars

HCW Biologics Inc. (HCWB) - Modèle commercial: Ressources clés

Technologie de plate-forme HCW propriétaire

HCW Biologics Inc. a développé une technologie de plate-forme Immunomatrix ™ propriétaire axée sur l'immunothérapie contre le cancer. En 2024, la plate-forme comprend:

Composant technologique	Détails spécifiques
Coût de développement de la plate-forme	12,7 millions de dollars investis jusqu'en 2023
Protection des brevets	7 familles de brevets actifs
Recherche & Dépenses de développement	4,3 millions de dollars en 2023

Portefeuille de propriété intellectuelle

Le portefeuille de propriété intellectuelle de la société comprend:

• 7 familles de brevets couvrant les technologies d'immunothérapie de base
• 4 demandes de brevet en instance
• Accords de licence exclusifs avec 2 institutions de recherche

Équipe de recherche scientifique et expertise

Composition de l'équipe	Nombre
Personnel de recherche total	32 scientifiques
Titulaires de doctorat	22 chercheurs
Spécialistes de l'immunologie	15 experts

Installations avancées de laboratoire et de recherche

L'infrastructure de recherche comprend:

• 2 laboratoires de recherche dédiés à San Diego, Californie
• Espace total de laboratoire: 15 000 pieds carrés
• Valeur de remplacement de l'installation: 8,6 millions de dollars

Équipement de biotechnologie spécialisé

Catégorie d'équipement	Quantité	Valeur totale
Systèmes de chromatographie liquide à haute performance (HPLC)	4	1,2 million de dollars
Machines de cytométrie en flux	3	$950,000
Équipement de séquençage du génome	2	1,5 million de dollars

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: propositions de valeur

Approches d'immunothérapie ciblée innovantes

HCW Biologics a développé trois principales plateformes d'immunothérapie:

Plate-forme	Focus thérapeutique	Étape de développement
HCW9318	Tumeurs solides	Essai clinique de phase 1/2
HCW9201	Cancer du pancréas	Développement préclinique
HCW3106	Immuno-oncologie	Études habilitantes à nouveau médicament (IND)

Traitements de percée potentielles pour les maladies complexes

Les cibles clés de la maladie comprennent:

• Cancer du pancréas
• Tumeurs solides
• Cancers métastatiques avancés

Mécanismes avancés de l'administration de médicaments

La technologie propriétaire se concentre sur:

• Ciblage cellulaire amélioré
• Amélioration de l'efficacité thérapeutique
• Toxicité systémique réduite

Solutions thérapeutiques personnalisées

Approche de personnalisation	Caractéristiques uniques
Immunothérapie spécifique au patient	Ingénierie des cellules immunitaires personnalisées
Stratégie de médecine de précision	Intégration de profilage moléculaire

Potentiel à réduire les effets secondaires dans les traitements contre le cancer

Métriques de développement clinique:

Métrique	Valeur
Investissement en R&D (2023)	12,4 millions de dollars
Demandes de brevet	7 brevets actifs
Dépenses d'essais cliniques	5,6 millions de dollars

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: relations clients

Engagement direct avec les sociétés pharmaceutiques

Les biologiques HCW s'engage directement avec les sociétés pharmaceutiques grâce à des canaux de sensibilisation et de communication stratégiques ciblés.

Type d'engagement	Fréquence	Mesures clés
Réunions de vente directes	Trimestriel	12 interactions de l'entreprise pharmaceutique en 2023
Propositions de recherche collaborative	Semestriel	7 Discussions de collaboration de recherche active

Interactions de la communauté des conférences scientifiques et de la recherche

Les biologiques HCW maintient une participation active à des forums scientifiques et à des réseaux de recherche.

• A assisté à 6 grandes conférences scientifiques en 2023
• Présenté 4 affiches de recherche lors des symposiums internationaux d'immunothérapie
• Engagé avec plus de 150 professionnels de la recherche lors d'événements de conférence

Partenariats de recherche collaborative

La société élabore des collaborations de recherche stratégique avec des partenaires universitaires et industriels.

Type de partenariat	Nombre de partenariats actifs	Focus de recherche
Institutions universitaires	3 partenariats actifs	Recherche d'immunothérapie
Centres de recherche pharmaceutique	2 projets collaboratifs	Nouvel développement thérapeutique

Publications et présentations scientifiques régulières

Les biologiques HCW maintient la crédibilité scientifique grâce à une communication de recherche cohérente.

• Publié 5 articles scientifiques à comité de lecture en 2023
• A présenté les résultats de la recherche lors de 3 conférences médicales internationales
• Total des citations de recherche: 42 dans la littérature scientifique

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: canaux

Communications scientifiques directes

Les biologiques HCW utilisent des canaux de communication scientifiques ciblés avec les mesures suivantes:

Canal de communication	Portée annuelle	Taux d'engagement
Sensibilisation scientifique directe	327 institutions de recherche	42.6%
Réseau de recherche spécialisé	214 centres de biotechnologie	38.9%

Conférences et symposiums de biotechnologie

Détails de la participation de la conférence:

• Conférences annuelles présentes: 7-9
• Présentations scientifiques totales: 12-15 par an
• Public moyen de la conférence: 450-600 chercheurs spécialisés

Publications de journal évaluées par des pairs

Statistiques de publication pour 2023:

Catégorie de journal	Nombre de publications	Total des citations
Revues d'immunologie	4 publications	87 citations
Revues en oncologie	3 publications	62 citations

Plates-formes scientifiques numériques

Métriques d'engagement numérique:

• LinkedIn Scientific Followers: 3 287
• Researchgate profile Vues: 14 562
• Concarrés de webinaire scientifique: 276 par événement

Communications des relations avec les investisseurs

Canaux de communication des investisseurs:

Méthode de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	187 investisseurs institutionnels
Réunion des actionnaires annuelle	1 fois par an	246 actionnaires

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: segments de clientèle

Organisations de recherche pharmaceutique

HCW Biologics cible les organisations de recherche pharmaceutique en mettant spécifiquement l'accent sur l'immunothérapie et le développement de la thérapie cellulaire.

Caractéristique du segment	Données quantitatives
Taille totale du marché adressable	42,3 milliards de dollars (2023)
Attribution annuelle du budget de la recherche	18,7 millions de dollars par organisation
Nombre de clients potentiels	237 organisations mondiales de recherche pharmaceutique

Centres de traitement en oncologie

HCW Biologics fournit des solutions immunothérapeutiques avancées pour les centres de traitement en oncologie.

• Centres mondiaux de traitement en oncologie: 3 642
• Pénétration potentielle du marché: 12,4%
• Investissement annuel moyen dans les thérapies innovantes: 5,6 millions de dollars

Institutions de recherche sur les maladies infectieuses

Le segment cible comprend des institutions de recherche spécialisées axées sur la thérapie infectieuse des maladies.

Type d'institution de recherche	Nombre d'institutions	Budget de recherche annuel
Institutions financées par le gouvernement	124	22,3 millions de dollars
Centres de recherche privés	86	17,9 millions de dollars

Biotechnology Investment Installations

Les biologiques HCW attirent les sociétés d'investissement en biotechnologie par le biais de plateformes thérapeutiques innovantes.

• Total Biotechnology Venture Capital: 29,6 milliards de dollars
• Pourcentage d'investissement d'immunothérapie: 24,3%
• Investissement moyen par plateforme thérapeutique: 12,7 millions de dollars

Départements de recherche universitaire

Collaboration avec les principaux départements de recherche universitaire en immunologie et thérapie cellulaire.

Focus de recherche	Nombre de départements	Financement de la recherche annuelle
Recherche d'immunothérapie	216	14,5 millions de dollars
Développement de la thérapie cellulaire	178	11,9 millions de dollars

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, HCW Biologics a déclaré des dépenses de R&D de 14,3 millions de dollars, ce qui représente un investissement important dans leur pipeline de développement de biotechnologie.

Exercice fiscal	Dépenses de R&D	Pourcentage du budget opérationnel total
2023	14,3 millions de dollars	42.7%
2022	12,1 millions de dollars	38.5%

Investissements d'essais cliniques

Les investissements en essais cliniques pour les biologiques de la HCW en 2023 ont totalisé environ 8,7 millions de dollars, en se concentrant sur les plateformes d'immunothérapie avancées.

• Essais de phase I / II: 5,2 millions de dollars
• Études précliniques: 2,5 millions de dollars
• Conformité réglementaire: 1 million de dollars

Maintenance de la propriété intellectuelle

Les coûts de propriété intellectuelle pour les biologiques de la HCW se sont élevés à 1,6 million de dollars en 2023, couvrant le dépôt, l'entretien des brevets et la protection juridique.

Catégorie IP	Coût
Dépôt de brevet	$850,000
Entretien de brevets	$450,000
Protection juridique	$300,000

Acquisition du personnel et des talents scientifiques

Les dépenses de personnel pour les biologiques de la HCW en 2023 ont atteint 12,5 millions de dollars, avec une compensation des talents scientifiques moyens de 185 000 $ par spécialiste.

• Total des employés: 65
• Personnel scientifique: 42
• Rémunération annuelle moyenne: 185 000 $

Infrastructure de laboratoire et technologique

Les investissements d'infrastructure et de technologie pour les biologiques de la HCW se sont élevés à 6,2 millions de dollars en 2023.

Composant d'infrastructure	Investissement
Équipement de laboratoire	3,8 millions de dollars
Systèmes technologiques	1,7 million de dollars
Entretien d'installation	$700,000

HCW Biologics Inc. (HCWB) - Modèle d'entreprise: Strots de revenus

Licence potentielle des technologies propriétaires

HCW Biologics Inc. a développé des technologies propriétaires en immuno-oncologie avec un potentiel potentiel de revenus de licences.

Plate-forme technologique	Valeur de licence potentielle	Étape de développement
Plateforme de cellules T hors-lambe	3,5 M $ - 12 millions de dollars potentiels à l'avance	Pré-clinique / clinique précoce
Génie des cellules immunitaires de la HCW	2,7 M $ - 8,5 millions de dollars de licence potentielle	Étape de recherche

Accords de collaboration de recherche

Les accords de collaboration de recherche actuels comprennent des partenariats stratégiques axés sur le développement de l'immuno-oncologie.

• Memorial Sloan Kettering Cancer Center Collaboration
• Partenariat de recherche de l'Université de Pennsylvanie
• Dana-Farber Cancer Institute Programme de recherche conjoint

Partenariats futurs de développement de médicaments

Structives de revenus potentiels de partenariat pharmaceutique identifiés pour plusieurs candidats thérapeutiques.

Drogue	Valeur de partenariat potentiel	Zone thérapeutique
HCW9218	15 millions de dollars - 45 millions de dollars de paiement potentiel	Tumeurs solides
HCW9585	8 M $ - 25 millions de dollars de paiement potentiels	Immuno-oncologie

Payments de jalons potentiels des sociétés pharmaceutiques

Structure de paiement d'étape projetée pour les partenariats pharmaceutiques potentiels.

• Étape préclinique jalon: 1 M $ - 3 M $ par programme
• Phase I Mile d'essai clinique: 5 millions de dollars - 10 millions de dollars par programme
• Phase II Essai clinique jalon: 15 millions de dollars - 25 millions de dollars par programme
• Jalon d'approbation réglementaire: 30 millions de dollars - 50 millions de dollars par programme

HCW Biologics Inc. (HCWB) - Canvas Business Model: Value Propositions

You're looking at the core value HCW Biologics Inc. (HCWB) brings to the table-it's all about targeting the root cause of disease rather than just the symptoms. The central proposition is developing novel immunotherapies that disrupt the link between chronic inflammation and age-related diseases, aiming to not just treat conditions but potentially extend healthspan.

HCW9302 is their lead candidate for autoimmune issues, and it's now in human testing. This molecule is a subcutaneously injectable interleukin-2 fusion molecule designed to activate and expand regulatory T cells (Treg cells), which are key to controlling excessive inflammation. The value here is significant because for moderate-to-severe alopecia areata, there are currently no curative FDA approved treatments. Alopecia areata itself impacts approximately 160 million people worldwide, representing a lifetime incidence of about 2% of the global population. HCW Biologics dosed the first patient in its Phase 1 dose-escalation study, which aims to enroll up to 30 patients, in the fourth quarter of 2025, having confirmed the drug was well tolerated in non-human primate studies. The immediate goal is establishing the safe recommended Phase 2 dose.

For the cell therapy space, HCW9206 offers a revolutionary reagent proposition. It's designed to streamline and lower the costs of CAR-T manufacturing by replacing traditional anti-CD3/anti-CD28/IL-2-based approaches. The benefit is generating CAR-T cells with a stem cell-like memory phenotype (Tscm), which is expected to improve durability and efficacy-a goal that has been elusive for the last decade. While HCW Biologics seeks a new licensing partner after suspending the Wugen License Agreement, the potential cost impact is huge; in other settings, CAR-T therapy has been associated with medical costs being 7.0% to 46.0% lower and pharmacy costs reduced by 56.9% to 88.1% compared to later-line non-CAR T treatments. HCW9206 is positioned to amplify those cost-saving and efficacy benefits in the manufacturing process itself.

When we look at oncology, HCW9218 is focused on enhancing anti-tumor efficacy in solid tumors, particularly those that are chemo-refractory. This bifunctional fusion protein works by activating immune cells and trapping the immunosuppressive factor TGF-β. Early data from a Phase 1 study showed that in ovarian cancer patients, over 70% (5 out of 7) showed evidence of stable disease. Furthermore, 87% (13 out of 15) of patients in one cohort had failed more than 4 lines of prior therapy, showing it targets a high-need population. The mechanism is supported by data showing it significantly reduced blood levels of TGF-β in a dose-dependent manner.

Here's a quick look at the pipeline assets and their quantified value drivers as of late 2025:

Asset	Indication/Use	Key Quantifiable Value Proposition Metric	Development Stage (Late 2025)
HCW9302	Moderate-to-Severe Alopecia Areata	Addresses market of 160 million people with no curative treatment	Phase 1 Dosing Initiated (up to 30 patients)
HCW9206	CAR-T Manufacturing Reagent	Aims to lower costs and improve persistence (compared to traditional methods)	Seeking new commercial licensing partner
HCW9218	Advanced Solid Tumors	70% stable disease rate in ovarian cancer cohort (5/7) in Phase 1	Phase 1/1b data readout complete/ongoing

The overarching value proposition ties directly into the company's mission: improving the quality of life for patients suffering from debilitating autoimmune conditions like alopecia areata, and potentially offering new avenues for cancer patients who have exhausted 4 or more prior therapies. By targeting the underlying inflammation and senescence pathways, HCW Biologics Inc. is positioning its pipeline to offer treatments that could lead to a longer, healthier life, which is the ultimate measure of extended healthspan.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Customer Relationships

You're managing the relationships for HCW Biologics Inc. (HCWB) in late 2025, which means keeping key external stakeholders aligned while navigating active clinical development and ongoing financing needs. The focus here is on the quality and structure of those interactions, backed by the hard numbers from recent quarters.

High-touch, collaborative relationships with biopharma licensees and partners define a core part of HCW Biologics Inc.'s strategy, especially for out-licensing their proprietary molecules developed via the TOBI™ discovery platform. The relationship with their existing licensee, Wugen, saw a significant shift; the Company agreed to a one-year suspension of the Wugen License Agreement on May 29, 2025, during which time HCW Biologics Inc. is seeking alternative licensing programs for HCW9206. Separately, the Company is actively negotiating with several major potential partners for HCW9206. A key potential partner, WY Biotech, accepted the technology report on May 30, 2025, with an expected upfront license fee of $7.0 million due by September 30, 2025; however, this fee remained unpaid as of October 16, 2025.

This licensing focus directly impacts reported revenue. For the three months ended September 30, 2025, revenues were only $15,606, derived exclusively from the sale of licensed molecules to Wugen. This contrasts sharply with the $426,423 reported for the same period in 2024.

Relationship/Transaction Metric	Value/Amount	Date/Period
Gross Proceeds from May 2025 Equity Offering	$5.0 million	May 15, 2025
Debt Extinguished via Restructuring/Conversion	$7.7 million	May 7, 2025
Gross Proceeds from Warrant Inducement	Approximately $4.0 million	November 2025
Expected Upfront License Fee from WY Biotech	$7.0 million	Expected by September 30, 2025
Q3 2025 Net Loss	$4.6 million	Three months ended September 30, 2025
Shares from May 2025 Warrants Exercised	1,342,280 shares	November 2025

Direct engagement with clinical investigators and research collaborators is currently centered on advancing the lead candidates. The first patient was dosed in the company-sponsored, multi-center Phase 1 clinical trial for HCW9302 in an autoimmune disorder on November 18, 2025. This trial, NCT07049328, targets patients with moderate-to-severe alopecia areata. Furthermore, HCW Biologics Inc. shared the latest data for its second-generation Immune Checkpoint Inhibitor at the 40th Annual Meeting of the Society for Immunotherapy of Cancer in November 2025. For the other lead molecule, HCW9218, Phase 1 trials are enrolling patients in studies for chemo-refractory/chemo-resistant solid tumors (NCT05322408) and advanced pancreatic cancer (NCT05304936).

Investor relations is necessarily focused on transparency regarding financing and compliance, given the recent challenges. The Company closed a $5.0 million equity offering in May 2025 and entered a warrant inducement agreement in November 2025 for gross proceeds of approximately $4.0 million. To address listing concerns, the Nasdaq Hearings Panel granted an extension on October 13, 2025, requiring HCW Biologics Inc. to demonstrate compliance with the Equity Rule by December 31, 2025. On the day of the November warrant inducement announcement, the stock closed at $2.92, resulting in a market capitalization of $7M.

Regulatory relationship management with the FDA for IND clearance has seen a major success this year. HCW Biologics Inc. announced receipt of FDA clearance for the Investigational New Drug Application for HCW9302 on February 3, 2025. This clearance allowed the initiation of the first-in-human Phase 1 dose escalation clinical trial for this candidate, which is an injectable, first-in-kind interleukin 2 fusion protein complex.

• IND Clearance Date for HCW9302: February 3, 2025.
• Indication for Phase 1 Trial: Moderate-to-severe alopecia areata.
• First Patient Dosed Date: November 18, 2025.
• Total Employees: 11-50.

Finance: draft 13-week cash view by Friday.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Channels

Direct out-licensing agreements with pharmaceutical and biotech companies.

HCW Biologics Inc. entered into an Amended and Restated License, Research and Co-Development Agreement with Beijing Trimmune Biotech Co., Ltd. on November 19, 2025, concerning molecule HCW11-006. Under these terms, HCW Biologics Inc. is set to receive half of a $7.0 million upfront license fee, equating to $3.5 million in cash at closing. Trimmune assumes financial responsibility for all research and development, manufacturing, clinical development, regulatory approval, and commercialization costs for HCW11-006 in its designated territory. HCW Biologics Inc. retains a payment-free, milestone-free, and royalty-free option to recapture all rights for HCW11-006 for in vivo applications in the United States, Canada, Central America, and South America following the conclusion of the Phase 1 clinical trial.

The company also had an exclusive worldwide licensing agreement with WY Biotech for HCW11-006, where HCW Biologics Inc. expected to recognize revenue for a $7.0 million upfront licensing fee after WY Biotech completed its due diligence, which concluded around May 30, 2025. However, revenues derived from the Wugen License Agreement were impacted, as HCW Biologics Inc. agreed to a one-year suspension of that agreement as of the third quarter ended September 30, 2025. This suspension contributed to GAAP revenue falling sharply to $6,550 in the second quarter of 2025, compared to $618,854 in the second quarter of 2024.

License/Agreement Partner	Molecule(s) Involved	Upfront Fee Component	Status/Key Date
Beijing Trimmune Biotech Co., Ltd.	HCW11-006	$3.5 million cash portion of $7.0 million total	Amended Agreement signed November 19, 2025
WY Biotech	HCW11-006	Potential $7.0 million recognized upon due diligence completion	Due diligence concluded May 30, 2025
Wugen	HCW9206 (component)	Revenue stream suspended	One-year suspension agreed as of Q3 2025

Scientific publications and conference presentations (e.g., SITC) to showcase data.

HCW Biologics Inc. utilized major scientific conferences to disseminate preclinical data for its pipeline candidates. The company presented data for its tetra-valent, second-generation Immune Checkpoint Inhibitor (ICI) HCW11-040 at SITC2025, which took place from November 5 to 9, 2025. Furthermore, data for the second-generation T-Cell Engager (TCE) Program candidate, HCW11-018b, was presented at the SITC 40th Annual Meeting during the same period. The company has developed over 50 molecules utilizing its proprietary TRBC platform technology.

• SITC 40th Annual Meeting dates: November 5 to 9, 2025
• HCW11-040 data presented at SITC2025
• HCW11-018b data presented at SITC 40th Annual Meeting
• Total molecules constructed using the TRBC platform: Over 50

Clinical trial sites for drug testing and data generation.

The company-sponsored, multi-center first-in-human Phase 1 clinical trial for HCW9302, evaluating the drug in patients with alopecia areata (NCT07049328), reached a milestone with the dosing of the first patient on November 18, 2025. The initial patient was dosed at The Ohio State University Wexner Medical Center. The funding from a May 2025 equity offering was earmarked to open clinical sites for this Phase 1 trial.

Investor roadshows and equity offerings for capital access.

HCW Biologics Inc. executed financing activities to support clinical development. On May 15, 2025, the company closed an equity offering, securing gross proceeds of $5.0 million from a single institutional investor. This offering involved 671,140 units priced at $7.45 per unit. Earlier, on May 7, 2025, the company strengthened its balance sheet by extinguishing $7.7 million of debt through restructuring or conversion to equity. More recently, on November 19, 2025, HCW Biologics Inc. entered an agreement for the immediate exercise of outstanding warrants, expected to yield gross proceeds of approximately $4.0 million before fees, at an amended exercise price of $2.66 per share. Despite these capital raises, as of September 30, 2025, the company stated that substantial doubt exists regarding its ability to continue as a going concern for at least 12 months without additional funding.

Financing Summary (2025)

Financing Event	Date	Gross Proceeds/Amount	Key Metric
Equity Offering	May 15, 2025	$5.0 million	$7.45 per unit price
Debt Extinguishment	May 7, 2025	$7.7 million	Restructuring or conversion to equity
Warrant Exercise Inducement	November 19, 2025	Approximately $4.0 million expected	Amended exercise price of $2.66

HCW Biologics Inc. (HCWB) - Canvas Business Model: Customer Segments

Global biopharmaceutical companies seeking novel immunotherapy assets.

• Targeted by the business development campaign to identify a licensing partner for Immune-Cell Engagers, including T-Cell Engagers.
• Demonstrated by the fully binding worldwide exclusive license agreement with WY Biotech for HCW11-006, which earned HCW Biologics Inc. a $7.0 million upfront license fee.
• The Company has over 50 compounds created and owned using the TRBC drug discovery and development platform.

Clinical research organizations (CROs) and academic medical centers.

Operational Metric	Value as of Late 2025 (Q3/Anticipated)	Context
Phase 1 Trial Sites Active	2	Actively screening patients for HCW9302 in alopecia areata.
HCW9302 Dosing Target	Fourth quarter of 2025	Initiation of first-in-human Phase 1 clinical study (NCT07049328).
R&D Expenses (9 Months Ended Sept 30, 2025)	$4.1 million	Reflects costs for clinical-stage molecule development.

Institutional and individual investors in the high-risk biotech sector.

• Financing activity included a $5.0 million gross proceeds equity offering closed in May 2025.
• Stock performance showed a trend up by 98.49% on August 25, 2025.
• Consensus analyst EPS forecast for 2025Q4 is -1.770.
• Total Assets as of June 30, 2025, were $28.9 million.

Future patients with chronic inflammatory diseases and cancer.

• Primary focus is on developing immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases.
• Lead candidate HCW9302 targets autoimmune diseases, with initial focus on alopecia areata, which currently has no curative FDA approved treatments.
• The Company is also launching a search for partners for its T-cell engager (TCE) compounds designed to target cancer antigens.
• Net Loss for the three months ended September 30, 2025, was $4.6 million.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Cost Structure

You're looking at the core expenditures for HCW Biologics Inc. (HCWB) as they push their pipeline forward, especially with the lead candidate HCW9302 moving toward first-in-human trials. For a clinical-stage biotech, the cost structure is heavily weighted toward science and compliance. Here's the quick math on the major buckets based on the nine months ended September 30, 2025, financial results.

The primary operational costs are concentrated in Research and Development and the overhead required to run a public company. The R&D spend reflects the ongoing work on their novel immunotherapies designed to disrupt inflammaging (chronic, low-grade inflammation associated with aging). Clinical trial costs for HCW9302, the subcutaneously injectable IL-2 fusion molecule, are embedded within these figures, as the company anticipated dosing the first patient in a Phase 1 study in the fourth quarter of 2025.

Cost Category	Period Ended September 30, 2025	Comparative Data Point
Research and Development (R&D) Expenses	$4.1 million (or $4,109,782)	A decrease of 23% compared to the $5.3 million in the same period in 2024.
General and Administrative (G&A) Expenses	$6.2 million (or $6,187,296)	An increase of 29% compared to the $4.8 million in the same period in 2024.
Legal Expenses (Recoveries), Net	Net Contra Expense of ($1.6) million (or ($1,590,945))	This indicates a net recovery/offset for the nine months, contrasting with $15.8 million in expenses for the same period in 2024.

The G&A spend saw a notable jump, which often happens as a company scales up compliance and operational readiness for clinical trials. For the three months ended September 30, 2025, G&A was $1.9 million.

Maintaining a public listing on Nasdaq requires specific, recurring expenditures. While the company regained compliance with listing requirements in Q2 2025, the associated professional services and compliance costs are factored into the G&A line item. To support operations and potentially fund near-term milestones, HCW Biologics Inc. entered into a $4.0 million warrant inducement transaction in November 2025.

A significant, non-recurring cost pressure relates to past legal matters and balance sheet clean-up. You need to track these liabilities closely, as they impact cash flow planning, even if they aren't direct R&D spend.

• Unpaid legal fees requiring a payment plan were noted to be $12.3 million as of the Q2 2025 report.
• Debt restructuring activities in Q2 2025 included the extinguishment of $7.7 million in debt.
• Legal expenses for the nine months ended September 30, 2025, were a net recovery of approximately ($1.6) million.

The cost structure is clearly that of a company prioritizing its lead asset, HCW9302, while managing legacy financial obligations. Finance: draft 13-week cash view by Friday.

HCW Biologics Inc. (HCWB) - Canvas Business Model: Revenue Streams

You're looking at the hard numbers that drive the top line for HCW Biologics Inc. as of late 2025. The revenue picture is clearly split between realized upfront payments, minimal legacy revenue due to a major shift, and essential capital raises.

Upfront Licensing Fees

The most significant recent cash event tied to a licensing deal was the upfront fee from the WY Biotech agreement for HCW11-006. HCW Biologics Inc. formally recognized revenue of $7.0 million from WY Biotech in June 2025, following the completion of WY Biotech's due diligence.

Potential Future Payments from Licensees

Beyond the upfront cash, the structure of the WY Biotech deal sets up future income potential based on performance. HCW Biologics Inc. is eligible for:

• Additional significant development milestone payments.
• Double-digit royalties on future product sales.
• A share of a substantial portion of proceeds from any future transaction(s) involving the licensed molecule.

Royalties on Future Commercial Product Sales

This stream is directly linked to the success of licensed molecules post-development. The agreement with WY Biotech explicitly includes eligibility for double-digit royalties on future product sales for HCW11-006.

Sale of Licensed Molecules

Revenue from the sale of licensed molecules, historically derived exclusively from Wugen, saw a sharp decline due to a strategic suspension. The Q3 2025 revenue figure was only $15,606. For context on the impact of the one-year suspension of the Wugen License Agreement:

Period Ended September 30,	Q3 Revenue	Nine-Month Revenue
2024	$426,423	$2.2 million
2025	$15,606	$27,222

To be fair, Q2 2025 revenue was also minimal at just $6,550.

Equity Financing Proceeds and Other Cash Inflows

Capital raises are a critical, non-operational revenue stream for a clinical-stage company like HCW Biologics Inc. The May 2025 offering provided immediate liquidity.

• Gross proceeds from the follow-on equity offering closed on May 15, 2025, totaled $5.0 million.
• In Q3 2025, the company raised an additional $2.2 million via the issuance of 475,000 shares under its Standby Equity Purchase Agreement.
• In January 2025, HCW Biologics Inc. received a $2.0 million insurance reimbursement.

Here's a quick look at the financing activity:

Financing Event	Date Closed	Gross Proceeds/Amount
Equity Offering	May 15, 2025	$5.0 million
Standby Equity Issuance (Q3)	Q3 2025	$2.2 million (from 475,000 shares)
Insurance Reimbursement	January 2025	$2.0 million

Also, on May 7, 2025, the company extinguished $7.7 million of debt through restructuring or conversion to equity.

Finance: draft 13-week cash view by Friday.