Aura Biosciences, Inc. (AURA): Canvas du modèle d'entreprise [Jan-2025 MISE À JOUR]

Dans le paysage rapide de la thérapeutique contre le cancer, Aura Biosciences, Inc. (Aura) apparaît comme une force pionnière, exerçant sa technologie de cancer révolutionnaire pour révolutionner les stratégies de traitement ciblées. En tirant parti des approches virales innovantes et de la médecine de précision, cette entreprise de biotechnologie est prête à transformer la façon dont nous conceptualisons et relevons des défis oncologiques complexes, offrant de l'espoir aux patients confrontés à des types de tumeurs difficiles grâce à des interventions thérapeutiques peu invasives et potentiellement plus efficaces.

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec Dana-Farber Cancer Institute

Aura Biosciences a établi une collaboration stratégique de recherche avec le Dana-Farber Cancer Institute axée sur le développement de nouveaux traitements en oncologie. Au quatrième trimestre 2023, le partenariat implique:

Détails du partenariat	Métriques spécifiques
Focus de recherche	Thérapies en oncologie virale
Investissement de recherche clinique	2,3 millions de dollars alloués pour 2024
Personnel de recherche conjoint	7 chercheurs seniors

Partenariats de recherche pharmaceutique

Aura Biosciences entretient des relations collaboratives avec plusieurs institutions de recherche pharmaceutique:

• Memorial Sloan Kettering Cancer Center
• Université de Californie, San Francisco (UCSF) Centre de recherche en oncologie
• MD Anderson Cancer Center

Type de partenariat	Valeur de collaboration	Durée
Collaboration de recherche	4,7 millions de dollars	2024-2026
Accord de partage de technologie	1,2 million de dollars	24 mois

Accords de licence pour le développement de médicaments en oncologie

Les accords de licence actuels comprennent:

• Droits de licence exclusifs pour Thérapie virale AU-011
• Paiements de jalons potentiels jusqu'à 85 millions de dollars
• Taux de redevance allant de 8 à 12%

Collaborations d'essais cliniques

Partenariats du Centre médical académique pour les essais cliniques:

Centre médical	Phase d'essai clinique	Budget de procès
Centre médical de Stanford	Phase II	3,6 millions de dollars
Université Johns Hopkins	Phase I / II	2,9 millions de dollars

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: activités clés

Développer de nouvelles thérapies contre le cancer à base virale

AURA Biosciences se concentre sur le développement de traitements en oncologie virale, en particulier le ciblage:

• Thérapeutique conjuguée virale
• Traitements du cancer de précision
• Approches thérapeutiques innovantes

Domaine de mise au point de recherche	État actuel	Étape de développement
Thérapies contre le cancer à base de viraux	Candidat principal: AU-011	Essais cliniques de phase 2
Traitement d'oncologie ciblé	Mélanome oculaire	Développement clinique avancé

Effectuer des recherches précliniques et cliniques pour les traitements en oncologie

Les activités de recherche comprennent:

• Évaluation préclinique de la thérapeutique conjuguée virale
• Conception et exécution des essais cliniques
• Recrutement et surveillance des patients

Métrique de recherche	Données quantitatives
Dépenses annuelles de R&D	48,3 millions de dollars (2023)
Investissement en essai clinique	22,7 millions de dollars

Découverte et développement de médicaments dans les thérapies du cancer ciblées

Capacités clés de découverte de médicaments:

• Technologie de conjugaison virale propriétaire
• Mécanismes de ciblage de l'oncologie de précision
• Techniques de génie moléculaire avancées

Plateformes technologiques propriétaires avancées

Plate-forme technologique	Caractéristiques uniques	Statut de développement
Plate-forme de conjugaison virale	Ciblage sélectif de cellules cancéreuses	Validé dans des études précliniques
Système de ciblage moléculaire	Approche thérapeutique de précision	Optimisation continue

Compliance réglementaire et gestion des essais cliniques

Les activités de conformité comprennent:

• Interaction et communication de la FDA
• Adhésion au protocole d'essai clinique
• Surveillance et rapport de la sécurité

Métrique réglementaire	Données quantitatives
Essais cliniques actifs	3 essais en cours
Soumissions réglementaires	2 applications IND (2023)

Aura Biosciences, Inc. (AURA) - Modèle commercial: Ressources clés

Plateforme de technologie des illuminateurs de cancer propriétaire

Aura Biosciences a développé un plateforme de thérapie par cancer à base de virale avec les caractéristiques clés suivantes:

Attribut technologique	Détails spécifiques
Statut de brevet	8 brevets délivrés au quatrième trimestre 2023
Focus technologique	Traitements oncologiques ciblés
Étape de développement	Plate-forme thérapeutique à stade clinique

Portefeuille de propriété intellectuelle

Les actifs de la propriété intellectuelle comprennent:

• 8 brevets accordés aux États-Unis
• Demandes de brevet multiples en attente
• Technologie de vecteur viral propriétaire

Expertise scientifique

Catégorie de recherche	Composition de l'équipe
Personnel de recherche total	37 membres du personnel scientifique
Chercheurs de doctorat	22 membres de l'équipe
Spécialistes en oncologie	15 chercheurs en oncologie dédiés

Installations de recherche et de développement

Détails de l'installation:

• Espace total de laboratoire de R&D: 12 500 pieds carrés
• Emplacement: Cambridge, Massachusetts
• Équipement de biologie moléculaire avancée

Équipe de recherche spécialisée

Expertise en équipe	Métriques quantitatives
Génie des vecteurs viraux	9 chercheurs spécialisés
Conception d'essais cliniques	6 professionnels de la recherche clinique dédiés
Conformité réglementaire	4 spécialistes des affaires réglementaires

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: propositions de valeur

Thérapie du cancer ciblée innovante

Aura Biosciences se concentre sur le développement Nouvelles thérapies contre le cancer avec un accent spécifique sur les thérapies virales. Le candidat principal de la société, AU-011, cible les cancers oculaires avec une approche unique.

Produit candidat	Indication cible	Étape de développement
AU-011	Mélanome choroïdien	Essai clinique de phase 2

Approche de traitement non invasive

La stratégie thérapeutique de l'entreprise implique un traitement viral ciblé qui vise à minimiser les dommages aux tissus sains environnants.

• Livraison vectorielle virale ciblée avec précision
• Méthodologie de traitement mini-invasive
• Potentiel de réduction des effets secondaires par rapport aux thérapies traditionnelles

Besoins médicaux non satisfaits en oncologie

Aura Biosciences traite des lacunes critiques dans le traitement du cancer, en particulier dans les types de tumeurs rares et difficiles.

Type de cancer	Limites de traitement actuelles	Avantage potentiel AU-011
Mélanome choroïdien	Options de traitement efficaces limitées	Thérapie virale ciblée

Approche de la médecine de précision

L'entreprise exploite ingénierie virale avancée pour créer des traitements contre le cancer très spécifiques.

• Technologie vectorielle virale propriétaire
• Ciblage sélectif des cellules cancéreuses
• Potentiel de stratégies thérapeutiques personnalisées

Stratégie thérapeutique mini-invasive

L'AU-011 représente une percée potentielle dans la livraison Traitements précis du cancer avec une toxicité systémique réduite.

Caractéristique du traitement	Approche AU-011
Méthode de livraison	Injection intravitréenne
Durée du traitement	Potentiel d'administration unique

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé en oncologie

Depuis le quatrième trimestre 2023, Aura Biosciences maintient des stratégies d'engagement directes avec 237 professionnels de la santé en oncologie dans 42 centres de traitement du cancer spécialisés.

Type d'engagement	Nombre de professionnels	Fréquence d'interaction
Leaders d'opinion clés	37	Trimestriel
Oncologues cliniques	156	Bimensuel
Spécialistes de la recherche	44	Mensuel

Programmes de recrutement de soutien aux patients et d'essais cliniques

Métriques de recrutement des essais cliniques pour 2023:

• Total des patients dépistés: 412
• Patients inscrits: 178
• Taux de rétention: 86,3%

Communication scientifique par le biais de conférences médicales

Participation de la conférence en 2023:

Type de conférence	Nombre de conférences	Présentations présentées
Conférences internationales en oncologie	7	12
Symposiums régionaux d'oncologie	15	22

Plateformes numériques pour la diffusion de l'information médicale

Statistiques d'engagement numérique pour 2023:

• Site Web Visiteurs uniques: 64 782
• Inscriptions du portail professionnel médical: 1 237
• Concarts du webinaire numérique: 2 345

Partenariats de recherche collaborative

Détails de la collaboration de recherche pour 2023:

Type de partenaire	Nombre de partenariats	Les domaines de recherche sur la recherche
Institutions universitaires	6	Oncologie oculaire
Hôpitaux de recherche	4	Thérapeutique du cancer

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: canaux

Ventes directes vers des centres de traitement en oncologie spécialisés

Depuis le quatrième trimestre 2023, Aura Biosciences cible les cibles 87 centres de traitement spécialisés en oncologie Aux États-Unis, pour les ventes directes de son produit principal, AU-011.

Type de canal	Nombre de centres	Couverture géographique
Ventes d'oncologie directes	87	États-Unis

Présentations de la conférence médicale

Aura Biosciences participe à 6-8 conférences d'oncologie majeures chaque année pour présenter la recherche et les résultats des essais cliniques.

• Association américaine pour la recherche sur le cancer (AACR)
• American Society of Clinical Oncology (ASCO)
• Société européenne pour l'oncologie médicale (ESMO)

Plateformes de publication scientifique

La société a publié 12 articles évalués par des pairs dans des revues scientifiques en 2023.

Plate-forme de publication	Nombre de publications
Journaux évalués par des pairs	12

Sites Web de communication numérique et de relations avec les investisseurs

Aura Biosciences maintient 2 canaux de communication numériques principaux:

• Site Web de l'entreprise: www.aurabiosciences.com
• Portail des relations avec les investisseurs

Partenariats avec des distributeurs pharmaceutiques

Actuellement engagé avec 3 partenaires de distribution pharmaceutique pour la distribution commerciale potentielle de l'AU-011.

Partenaire de distribution	Statut de partenariat
Amerisourcebergen	Discussions actives
Santé cardinale	Négociations préliminaires
McKesson	Stade exploratoire

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: segments de clientèle

Centres de traitement en oncologie

Au quatrième trimestre 2023, Aura Biosciences cible 247 centres de traitement en oncologie spécialisés aux États-Unis.

Catégorie	Nombre de centres	Pénétration potentielle du marché
Centres de cancer complets	51	20.6%
Centres d'oncologie communautaire	196	79.4%

Hôpitaux de recherche sur le cancer spécialisés

La société se concentre sur 89 hôpitaux de recherche sur le cancer spécialisés en Amérique du Nord.

• Centres désignés par le National Cancer Institute (NCI): 52
• Centres médicaux académiques: 37

Patients avec des types de tumeurs spécifiques

Cible la population de patients pour le produit principal d'AURA, AU-011:

Type de tumeur	Patients annuels estimés
Mélanome oculaire	1,250
Autres tumeurs solides rares	3,750

Institutions de recherche pharmaceutique

Aura Biosciences collabore avec 63 institutions de recherche pharmaceutique dans le monde.

• États-Unis: 37 institutions
• Europe: 18 institutions
• Asie-Pacifique: 8 institutions

Organisations de recherche gouvernementales et privées

Engagement avec les organisations de recherche en 2024:

Type d'organisation	Nombre d'organisations	Statut de collaboration de recherche
Organisations de recherche gouvernementale	22	Collaboration active
Organisations de recherche privée	41	Partenariat en cours

Aura Biosciences, Inc. (AURA) - Modèle d'entreprise: Structure des coûts

Investissements approfondis de recherche et développement

Pour l'exercice 2023, Aura Biosciences a déclaré des dépenses de R&D de 44,6 millions de dollars, ce qui représente une partie importante de leurs coûts opérationnels.

Catégorie de dépenses de R&D	Montant ($)
Recherche préclinique	12,3 millions
Développement d'essais cliniques	18,7 millions
Équipement de laboratoire	6,2 millions
Personnel de recherche	7,4 millions

Dépenses des essais cliniques

Les coûts des essais cliniques pour 2023 ont totalisé environ 22,5 millions de dollars, en mettant principalement l'accent sur les développements thérapeutiques en oncologie.

• Essais cliniques de phase I: 8,3 millions de dollars
• Essais cliniques de phase II: 14,2 millions de dollars

Protection et entretien de la propriété intellectuelle

Les coûts annuels de propriété intellectuelle pour le dépôt et l'entretien des brevets ont été de 1,2 million de dollars en 2023.

Compensation du personnel scientifique

Catégorie de personnel	Nombre d'employés	Compensation totale ($)
Chercheur principal	22	4,6 millions
Associés de recherche	45	3,8 millions
Spécialistes de la recherche clinique	18	2,9 millions

Processus de conformité et d'approbation réglementaires

Les dépenses de conformité réglementaire pour 2023 s'élevaient à 3,7 millions de dollars, couvrant les processus de soumission, d'examen et de consultation de la FDA.

• Frais de demande de la FDA: 1,2 million de dollars
• Conseil de conformité: 1,5 million de dollars
• Préparation de la documentation: 1,0 million de dollars

AURA Biosciences, Inc. (AURA) - Modèle d'entreprise: sources de revenus

Commercialisation potentielle des médicaments futurs

Depuis le quatrième trimestre 2023, Aura Biosciences se concentre sur le développement de son candidat principal, AU-011, pour le traitement des cancers oculaires. Les sources de revenus potentielles de la commercialisation des médicaments comprennent:

Produit	Marché potentiel	Taille du marché estimé
AU-011	Mélanome choroïdien	Marché annuel potentiel de 150 millions de dollars

Subventions et financement de recherche

Aura Biosciences a obtenu un financement de recherche à partir de diverses sources:

Source de financement	Montant	Année
National Institutes of Health (NIH)	2,3 millions de dollars	2023

Accords de licence potentiels

Strots de revenus potentiels des technologies de licence:

• Plate-forme d'administration de médicaments axée sur l'oncologie
• Thérapeutique basée sur le vecteur viral
• Revenus de licence annuelle potentielle estimée à 5 à 10 millions de dollars

Partenariats de recherche collaborative

Partenariats de recherche en collaboration actuels et potentiels:

Partenaire	Domaine de mise au point	Valeur potentielle
Société pharmaceutique non divulguée	Oncologie oculaire	Jusqu'à 50 millions de dollars en paiements de jalons potentiels

Paiements de jalons potentiels provenant de partenariats pharmaceutiques

Structure potentielle de paiement des étapes pour l'AU-011:

• Jalon préclinique: 5 millions de dollars
• Phase I Mile d'essai clinique: 10 millions de dollars
• Phase II Essai clinique jalon: 25 millions de dollars
• Jalon d'approbation réglementaire: 50 millions de dollars

Aura Biosciences, Inc. (AURA) - Canvas Business Model: Value Propositions

You're looking at the core value Aura Biosciences, Inc. (AURA) offers to its customer segments, which is centered on its lead candidate, bel-sar (AU-011), a Virus-Like Drug Conjugate (VDC).

Vision-sparing treatment for early choroidal melanoma, a high unmet need

For early-stage choroidal melanoma, there are currently no drugs approved. Aura Biosciences, Inc. is addressing this with its Phase 3 CoMpass trial, which is the first registration-enabling study in this indication. The study is a global, Phase 3, randomized trial evaluating bel-sar against a sham control arm. It includes an enrichment strategy to enroll approximately 100 patients with documented tumor growth. Enrollment for this trial is expected to complete in 2026, with topline data for the 15-month primary endpoint anticipated in Q4 2027. Investigators have registered over 240 patients in the pre-screening tool as having met initial enrollment criteria globally since June 2024, highlighting the need. Aura Biosciences, Inc. has received Orphan Drug Designation from the FDA and EMA, plus Fast Track designation from the FDA for this treatment.

Precision therapy designed to selectively destroy tumor cells while preserving organ function

The value proposition is rooted in precision, aiming to preserve organ function, particularly vision, which is critical for ocular oncology patients. This precision approach is being extended beyond early choroidal melanoma into other ocular indications where approved therapies are also absent.

Aura Biosciences, Inc. is exploring bel-sar for metastases to the choroid, which affects approximately 20,000 patients annually in the United States and Europe, and for cancers of the ocular surface, which affect approximately 35,000 patients annually in the United States and Europe. These three ocular oncology indications represent a collective incidence of greater than 60,000 patients annually in the US and Europe.

The company's financial position as of September 30, 2025, included cash and marketable securities totaling $161.9 million, which the company believes is sufficient to fund operations into the first half of 2027. Research and development expenses for the three months ended September 30, 2025, were $22.2 million. The net loss for that same quarter was $26.13 million.

Novel dual mechanism of action: targeted cytotoxicity and anti-tumor immune activation

The therapy's mechanism is designed to be dual-acting. Immune profiling data from Phase 1 trials reinforce bel-sar's distinct dual mechanism, driving focal anti-tumor immune activation. This mechanism has the potential to convert 'Cold' to 'Hot' Tumors.

Potential frontline, organ-preserving therapy for Non-Muscle Invasive Bladder Cancer (NMIBC)

Aura Biosciences, Inc. is advancing bel-sar in a Phase 1b/2 trial for NMIBC. Data from this trial are expected in mid-2026. Immune profiling data support bel-sar's potential as a differentiated frontline, organ-preserving treatment across the bladder cancer spectrum.

Here's a quick look at the clinical development milestones supporting these value propositions:

Indication	Trial Phase	Key Data Expected	Patient Population Scope (US/EU Annually)
Early Choroidal Melanoma	Phase 3 (CoMpass)	Enrollment Completion: 2026	High unmet need; no approved drugs
Early Choroidal Melanoma	Phase 3 (CoMpass)	Topline Data (Primary Endpoint): Q4 2027	Approximately 100 patients targeted for enrollment
Non-Muscle Invasive Bladder Cancer (NMIBC)	Phase 1b/2	Data Readout: Mid-2026	Not explicitly quantified in millions for NMIBC alone
Metastases to the Choroid	Phase 2	Initial Data: 2025	Approximately 20,000 patients

The company also reported a basic loss per share from continuing operations of $0.40 for the third quarter ended September 30, 2025. They strengthened the balance sheet with a recent equity financing, raising approximately $69.9 million, which contributed to an increase in additional paid-in capital to $611.5 million.

You should review the latest cash burn rate against the cash runway extending into the first half of 2027.

Aura Biosciences, Inc. (AURA) - Canvas Business Model: Customer Relationships

You're hiring before product-market fit, so your customer relationships are almost entirely focused on the clinical and financial communities that will validate your value proposition. For Aura Biosciences, Inc., this means intense focus on the investigators running the trials and the investors funding the journey.

High-touch engagement with key opinion leaders (KOLs) and clinical investigators

The relationship with clinical investigators is mission-critical, given that Aura Biosciences, Inc. is running its first registration-enabling study, the Phase 3 CoMpass trial, for early choroidal melanoma. This requires a highly involved, site-by-site engagement model to manage the unique enrollment criteria. The company noted that in 2025, they implemented measures to address operational challenges that had slowed enrollment.

The depth of engagement is reflected in the scale of the ongoing studies and the targeted patient populations. The CoMpass trial is designed to enroll approximately 100 patients with documented tumor growth. To support this, investigators registered over 240 patients in the pre-screening tool as having met initial enrollment criteria for the study as of the third quarter of 2025. This level of activity necessitates close, high-touch support for the sites managing these complex protocols.

Here's a quick look at the key clinical relationship milestones and the patient populations they address:

Indication/Trial	Trial Phase	Enrollment Status/Target	Data Expectation
Early Choroidal Melanoma (CoMpass)	Phase 3	Enrollment completion expected in 2026	Topline data anticipated in late 2027
Non-Muscle Invasive Bladder Cancer (NMIBC)	Phase 1b/2	Actively enrolling	Data expected in mid-2026
Metastases to the Choroid	Phase 2	Sites activated with patients in prescreening (US)	Initial data expected in 2025 (per Q2 report)

What this estimate hides is the constant need for scientific exchange to ensure protocol adherence and data integrity across global sites. It's defintely a relationship built on scientific partnership.

Direct communication with patient advocacy groups for rare oncology indications

For Aura Biosciences, Inc., patient advocacy groups are crucial partners because their lead candidate, bel-sar, targets rare oncology indications with high unmet medical needs. Direct communication helps ensure the clinical trial design aligns with patient priorities and addresses the urgency felt by these communities.

The focus areas represent significant, though rare, patient pools in the US and Europe:

• Early Choroidal Melanoma: An area with no approved drugs.
• Metastases to the Choroid: Affecting approximately 20,000 patients annually in the US and Europe.
• Cancers of the Ocular Surface: Affecting approximately 35,000 patients annually in the US and Europe.

The collective annual incidence for these three ocular oncology indications is greater than 60,000 patients in the United States and Europe. This focus on niche, underserved populations makes advocacy relationships a primary channel for awareness and potential future patient identification.

Investor relations and public disclosures for a clinical-stage company

As a clinical-stage company with no revenue, the relationship with the investment community is managed through rigorous, transparent financial and operational disclosures. The company's communication strategy centers on providing clear guidance on clinical milestones against its cash position.

Key figures from the third quarter ended September 30, 2025, frame the ongoing dialogue with investors:

Financial Metric (Q3 2025)	Amount (in thousands, except per share)	Comparison/Context
Net Loss	$26.1 million	Increased from $21.0 million in Q3 2024
Total Operating Expenses	$27.9 million	Driven by R&D costs
Research and Development Expenses	$22.2 million	Primary driver of operating expense increase
Total Assets	$190.0 million	Balance sheet strength
Additional Paid-in Capital	$611.5 million	Reflecting recent equity financing

The company highlighted that following a recent equity financing (reported in Q2 2025), the cash position was expected to support operations into the first half of 2027. Furthermore, the most recent analyst rating on the stock was a Buy with a $22.00 price target, showing a segment of the financial community is aligned with the near-term data catalysts.

Scientific and medical affairs support for clinical trial sites

The support provided to clinical trial sites is directly tied to the investment in research and development. This support ensures the scientific integrity of the data being generated, which is the ultimate value driver for Aura Biosciences, Inc.

The financial commitment underscores this support structure. Research and development expenses for the three months ended September 30, 2025, were $22.2 million. This spend primarily covers ongoing clinical and Clinical Research Organization (CRO) costs associated with the progression of the global Phase 3 trial and manufacturing/development costs for bel-sar. The relationship with CROs and site staff is therefore heavily subsidized by this operational expenditure, ensuring sites have the resources to execute the complex protocols for both the Phase 3 CoMpass trial and the Phase 1b/2 trial in NMIBC.

The company is focused on driving a cash-efficient operation to deliver data across its pipeline. Finance: draft 13-week cash view by Friday.

Aura Biosciences, Inc. (AURA) - Canvas Business Model: Channels

You're looking at how Aura Biosciences, Inc. gets its precision therapies, like bel-sar, to the specialized patient populations it targets. Since the company is still clinical-stage as of late 2025, the primary channels are centered on clinical execution and data dissemination, with commercial channels being strictly future planning.

Global network of specialized clinical trial sites (ophthalmology and urology)

The current channel for product validation relies entirely on a global network of clinical trial sites. For the lead indication, early-stage choroidal melanoma, the Phase 3 CoMpass trial is actively enrolling globally. To support this, investigators registered over 240 patients in a pre-screening tool as having met initial enrollment criteria for the study as of August 2025.

The NMIBC program uses a different channel structure for its Phase 1b/2 trial, which is actively enrolling approximately 26 intermediate and high-risk NMIBC patients. Furthermore, the Phase 2 trial in metastases to the choroid has activated sites with patients in prescreening in the United States. The company is planning to initiate a Phase 1 trial for cancers of the ocular surface in 2025.

Direct sales force to specialized ophthalmologists and urologists post-approval (future)

A dedicated direct sales force is a post-approval channel, so concrete numbers for that structure aren't public yet. However, you can see the investment in the personnel infrastructure that will support future commercialization. Research and development expenses, which include clinical costs, rose to $22.2 million for the three months ended September 30, 2025. General and administrative expenses, which cover corporate growth, were $5.7 million for the three months ended September 30, 2025, driven primarily by higher personnel expenses related to the growth of the Company.

The company's cash and marketable securities totaled $161.9 million as of September 30, 2025, which the company believes is sufficient to fund operations into the first half of 2027. This runway is critical for building out the necessary commercial infrastructure when approvals arrive.

Scientific publications and medical conferences for data dissemination

Dissemination of clinical data is a key channel for building scientific credibility and future market acceptance. Aura Biosciences, Inc. actively uses medical conferences to present its findings. Here's a look at the key dissemination events through late 2025:

Channel/Event Type	Specific Event/Data Point	Date/Period	Metric/Data Point
Medical Conference Presentation	40th Annual European Association of Urology (EAU) Congress	March 21-24, 2025	Presented Late-Breaking Abstract on NMIBC Phase 1 data.
Investor Event	Virtual Urologic Oncology Investor Event	March 24, 2025	Hosted event to discuss NMIBC data.
Investment Conference	H.C. Wainwright 27th Annual Global Investment Conference	September 10, 2025	Participation confirmed.
Investment Conference	8th Annual Evercore Healthcare Conference	December 2, 2025	Participation confirmed.
Clinical Data Readout Expectation	Initial three-month data from NMIBC Phase 1b/2 trial	Mid-2026	Expected data availability.

Early proof-of-concept results from the metastases to the choroid and ocular surface trials are also expected in 2026.

Regulatory submission pathways (FDA, EMA) for market authorization

The regulatory pathway itself acts as a critical channel to market access. Aura Biosciences, Inc. has secured several designations that streamline this process for its lead candidate, bel-sar, in early-stage choroidal melanoma.

• Orphan Drug Designation received from the FDA.
• Orphan Drug Designation received from the European Medicines Agency (EMA).
• Fast Track designation from the FDA for early-stage choroidal melanoma.
• The CoMpass trial is under a Special Protocol Assessment (SPA) agreement with the FDA.
• FDA Fast Track designation received for metastases to the choroid indication.

Enrollment for the registration-enabling Phase 3 CoMpass trial is expected to complete in 2026, with topline 15-month primary endpoint data anticipated in the fourth quarter of 2027.

Finance: review Q4 2025 cash burn projections against the H1 2027 cash runway estimate by next Tuesday.

Aura Biosciences, Inc. (AURA) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Aura Biosciences, Inc. (AURA) is targeting with bel-sar, which is key to understanding their near-term commercial focus. The strategy centers on rare ocular cancers first, then expanding into urologic oncology.

Adult patients with Early-stage Choroidal Melanoma (primary focus)

This is the lead indication, where Aura Biosciences, Inc. (AURA) is running the global Phase 3 CoMpass trial. The need is clear, as there are no FDA-approved therapies for this condition.

• Annual incidence in the United States and Europe is approximately 11,000 patients.
• The target for first-line therapy includes small melanomas and indeterminate lesions, representing about 9,000 patients in the US/EU.
• The Phase 3 CoMpass trial uses an enrichment strategy targeting approximately 100 patients with documented tumor growth.
• Investigators registered over 240 patients in the pre-screening tool as meeting initial enrollment criteria as of Q2 2025.
• Enrollment completion for the CoMpass trial is projected for the end of 2025.

The Phase 2 data provides a concrete look at potential efficacy for this segment:

Efficacy Metric (Phase 2 Data)	Result	Context
Tumor Control Rate	80% (8 out of 10 patients)	For Phase 3 eligible patients
Visual Acuity Preservation Percentage	90%	Preserving vision is critical for this patient group
Average Tumor Growth Rate (Pre-treatment)	0.351 mm/yr	Baseline measure
Average Tumor Growth Rate (Post-treatment)	0.011 mm/yr	Demonstrates control

Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) (Phase 1b/2)

Aura Biosciences, Inc. (AURA) is exploring bel-sar as a potential front-line treatment for NMIBC, which is a significant market opportunity, though secondary to the ocular focus right now. The Phase 1b/2 trial is actively enrolling.

• The ongoing Phase 1b/2 trial will evaluate approximately 26 intermediate and high-risk NMIBC patients.
• Phase 1 data showed that a single focal administration induced adaptive immune memory in 3/5 participants evaluated.
• Initial three-month clinical data from the Phase 1b/2 trial is expected in mid-2026.

Patients with Metastases to the Choroid

This is the second potential ocular indication being pursued via a Phase 2 clinical trial, which has an expanded inclusion criteria to cover various solid tumor metastases.

• This indication affects approximately 20,000 US/EU patients annually.
• Aura Biosciences, Inc. (AURA) initiated a Phase 2 clinical trial in this area.
• Initial proof of concept data from this trial is expected in 2026, following protocol amendments to broaden entry criteria.

Specialized oncologists and ophthalmologists treating rare ocular cancers

These are the key prescribers and decision-makers who manage patients across the ocular oncology pipeline indications. Their adoption is tied directly to the success of the Phase 3 CoMpass trial.

• The three ocular oncology indications (Early-stage CM, Metastases to the Choroid, Ocular Surface Cancers) have a collective incidence greater than 60,000 patients annually in the US and Europe.
• The company's cash position as of September 30, 2025, was $161.9 million, which supports the ongoing clinical operations necessary to engage these specialists.
• Research and development expenses for Q3 2025 were $22.2 million, reflecting the investment in trials that these specialists will eventually run or participate in.

Aura Biosciences, Inc. (AURA) - Canvas Business Model: Cost Structure

You're looking at a clinical-stage biotech, so the cost structure is almost entirely weighted toward getting that lead asset, bel-sar, across the finish line. This means heavy, non-negotiable spending on science and trials.

Heavy investment in Research and Development (R&D) and clinical trials is the defining characteristic here. This spending fuels the VDC platform advancement and the critical global Phase 3 CoMpass trial for early choroidal melanoma, plus the ongoing work in non-muscle invasive bladder cancer (NMIBC).

Here's the quick math on the latest reported period:

Expense Category	Amount (Q3 2025)
Research and Development (R&D) Expenses	$22.2 million
General and Administrative (G&A) Expenses	$5.7 million
Total Operating Expenses	$27.9 million

The R&D expenses were reported at $22.2 million for Q3 2025. That figure primarily reflects the ongoing clinical and contract research organization (CRO) costs associated with the progression of the Phase 3 trial, plus higher personnel expenses tied to company growth.

Manufacturing and supply chain costs for the VDC platform and bel-sar are embedded within R&D, but they represent a significant, lumpy cost. You saw these costs explicitly mentioned as a driver for R&D increases in prior periods, showing that preparing for potential commercial scale, even while still in trials, requires upfront investment in manufacturing processes and supply chain readiness for the Virus-Like Drug Conjugates (VDCs).

General and administrative (G&A) expenses, including personnel and professional fees, are the next largest bucket. For the three months ended September 30, 2025, G&A expenses were $5.7 million. This is actually a slight decrease from the $6.2 million reported in the same period last year, which management attributed to reduced professional fees, though personnel expenses related to company growth definitely factor in.

Costs associated with intellectual property maintenance and regulatory filings are necessary overhead for a company with a platform technology like Aura Biosciences, Inc. You see this commitment in action:

• Patent application filed with the U.S. Patent and Trademark Office for a new formulation of bel-sar for urologic oncology.
• If issued, this patent is designed to provide coverage for that formulation into the year 2046.
• These costs ensure the exclusivity of the VDC platform and bel-sar across indications.

Honestly, for a company with no revenue, every dollar spent is an investment in future value, and the current structure shows that investment is overwhelmingly directed toward clinical execution. Finance: draft 13-week cash view by Friday.

Aura Biosciences, Inc. (AURA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Aura Biosciences, Inc. (AURA) as of late 2025. Since the company is still firmly in the clinical-stage, the current revenue picture is lean, focusing mostly on non-operating income while the core value driver, bel-sar, moves through late-stage trials. Honestly, for a company like Aura Biosciences, the revenue streams are almost entirely prospective right now.

The primary financial inflow not tied to product sales is from their treasury. As of the third quarter ended September 30, 2025, Aura Biosciences reported interest income, including amortization and accretion income, of $1.8 million for that three-month period. This income is generated from their cash and marketable securities, which supports their ongoing operations while they await clinical milestones.

Here's a quick look at the current and near-term revenue components for Aura Biosciences:

Revenue Component	Status/Timing	Financial Data Point
Product Sales (bel-sar)	Pre-Commercial (Clinical-Stage)	$0 for the 2025 fiscal year
Interest Income	Current Operating Income	$1.8 million for Q3 2025
Future Commercial Sales (bel-sar)	Post-Regulatory Approval	Projected topline data readout for Phase 3 CoMpass trial in Q4 2027

The entire commercial revenue potential hinges on the success of bel-sar. You know the timeline; enrollment for the global Phase 3 CoMpass trial in early choroidal melanoma is expected to complete in 2026, leading to the critical topline data readout in Q4 2027. That readout is the gatekeeper for any future product sales revenue.

Beyond direct sales, Aura Biosciences has other potential, albeit currently unrealized, revenue avenues inherent to their business structure:

• Potential milestone payments from future licensing or partnership agreements.
• Royalties from future licensing or partnership agreements.

To be fair, these non-product revenue streams are speculative until a deal is signed, but they are a standard part of the business model for clinical-stage biotechs looking to share development costs or expand market reach. The current focus, reflected in the Q3 2025 operating expenses, is clearly on R&D to get bel-sar to that Q4 2027 data point.

Finance: draft 13-week cash view by Friday.