Spruce Biosciences, Inc. (SPRB): Business Model Canvas [Jan-2025 Mis à jour]

Spruce Biosciences, Inc. (SPRB) émerge comme une société de biotechnologie pionnière révolutionnant les traitements des troubles endocriniens pédiatriques grâce à son approche thérapeutique innovante et ciblée. En se concentrant sur les conditions génétiques rares et les besoins médicaux non satisfaits, l'entreprise exploite une expertise scientifique sophistiquée et des technologies de recherche de pointe pour développer des solutions transformatrices qui promettent de remodeler les soins aux patients dans des troubles hormonaux complexes. Leur modèle commercial stratégique démontre un cadre complet pour relever les défis critiques des soins de santé tout en se positionnant à l'avant-garde de la médecine de précision et des thérapies génétiques personnalisées.

Spruce Biosciences, Inc. (SPRB) - Modèle commercial: partenariats clés

Collaboration avec les centres médicaux universitaires pour la recherche clinique

En 2024, Spruce Biosciences a établi des partenariats avec les centres médicaux académiques suivants pour la recherche clinique:

Centre médical	Focus de recherche	Essais cliniques actifs
École de médecine de l'Université de Stanford	Hyperplasie surrénalienne congénitale (CAH)	2 essais de phase 2/3 en cours
Université de Californie, San Francisco	Endocrinologie pédiatrique	1 essai de phase 3

Partenariats stratégiques avec les institutions de recherche pharmaceutique

Spruce Biosciences a développé des partenariats stratégiques avec les institutions de recherche pharmaceutique suivantes:

• Centre de recherche de la société endocrinienne
• National Institutes of Health (NIH) Diseases rares Réseau de recherche clinique
• Société endocrinienne pédiatrique

Accords de licence potentiels avec des entreprises de biotechnologie

Les accords de licence et de collaboration actuels comprennent:

Entreprise de biotechnologie	Type d'accord	Focus sur le développement des médicaments
Biosciences neurocrines	Collaboration de recherche	Tildacerfont pour le traitement CAH

Engagement avec les organismes de réglementation

Interactions et engagements réglementaires:

• Interactions de la FDA: Réunions multiples de type B et de type C concernant le développement de TildacerFont
• Désignation de médicaments orphelins pour Tildacerfont dans le traitement CAH
• Communication continue avec la division du métabolisme et des produits d'endocrinologie de la FDA

Investissements totaux de partenariat et de collaboration en 2023: 4,2 millions de dollars

Nombre de collaborations de recherche active: 5

Budget d'extension de partenariat projeté pour 2024: 5,6 millions de dollars

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: Activités clés

Développer des solutions thérapeutiques innovantes pour des troubles endocriniens rares

Spruce Biosciences se concentre sur le développement de solutions thérapeutiques spécifiquement pour les troubles endocriniens rares pédiatriques. L'accent principal de l'entreprise est sur Hyperplasie surrénalienne congénitale (CAH).

Drogue	Étape de développement	Indication cible
Tildacerfont	Essai clinique de phase 2	CAH classique

Effectuer des essais précliniques et cliniques

La société investit des ressources importantes dans le développement et l'exécution des essais cliniques.

• Total des dépenses de R&D pour 2022: 43,9 millions de dollars
• Sites d'essai cliniques: environ 20 emplacements à travers les États-Unis
• Inscription des patients à des essais en cours: environ 100 patients

Recherche et développement de traitements de la maladie endocrinienne pédiatrique

Métrique de R&D	2022 données
Personnel de R&D	35 chercheurs dévoués
Investissement annuel de R&D	43,9 millions de dollars

Processus de soumission réglementaire et d'approbation des médicaments

Spruce Biosciences s'engage activement avec les autorités réglementaires pour faire progresser le développement de médicaments.

• Interactions en cours avec la FDA pour TildacerFont
• Demande d'enquête sur le médicament nouveau (IND) soumis
• Désignation des médicaments orphelins reçus pour TildacerFont

Jalon réglementaire	Statut
Communication de la FDA	Consultation active
Statut de médicament orphelin	Accordé pour Tildacerfont

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: Ressources clés

Expertise scientifique et médicale spécialisée dans les troubles endocriniens

Depuis le quatrième trimestre 2023, Spruce Biosciences a une équipe de recherche dédiée de 28 professionnels spécialisés axés sur les troubles endocriniens.

Catégorie professionnelle	Nombre d'employés
Chercheurs de doctorat	12
Médecins	6
Spécialistes de la recherche clinique	10

Technologies de développement de médicaments propriétaires

Les plates-formes technologiques clés comprennent:

• Plateforme de développement thérapeutique des troubles endocriniens pédiatriques
• Technologie avancée d'ingénierie moléculaire
• Système de modulation d'hormones de précision

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre total
Brevets délivrés	7
Demandes de brevet en instance	15
Familles de brevets	4

Installations de recherche et infrastructure de laboratoire

Espace total des installations de recherche: 8 500 pieds carrés situés à San Francisco, en Californie.

Type de laboratoire	Équipement spécialisé
Laboratoire de biologie moléculaire	3 machines de séquençage de gènes de haute précision
Usine de culture cellulaire	5 postes de travail de niveau de biosécurité avancés
Laboratoire de chimie analytique	2 systèmes de spectrométrie de masse

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: propositions de valeur

Répondre aux besoins médicaux non satisfaits dans les maladies endocriniennes pédiatriques rares

Spruce Biosciences se concentre sur le développement de thérapies pour des troubles endocriniens pédiatriques rares, ciblant spécifiquement:

Trouble	Population de patients	ÉTACKES DE TRAITEMENT
Hyperplasie surrénalienne congénitale (CAH)	Environ 1 naissance sur 10 000 à 15 000	Options thérapeutiques ciblées limitées
46, Trouble XY du développement du sexe	Estimé 1 sur 20 000 naissances vivantes	Approches de traitement spécialisé minimal

Développer des thérapies ciblées avec un potentiel pour améliorer les résultats des patients

Le développement thérapeutique clé de Spruce Biosciences se concentre sur:

• TildacerFont: Traitement non stéroïdal de premier classe pour CAH
• Approche de la médecine de précision ciblant des mutations génétiques spécifiques
• Réduction potentielle de l'exposition chronique aux stéroïdes chez les patients pédiatriques

Approches de traitement innovantes pour les troubles hormonaux complexes

Détails de l'investissement de la recherche et du développement:

Métrique	Valeur 2023
Dépenses de R&D	31,4 millions de dollars
Dépenses d'essais cliniques	22,6 millions de dollars

Solutions thérapeutiques personnalisées pour des conditions génétiques spécifiques

Éléments de proposition de valeur unique:

• Thérapies moléculaires ciblées avec précision
• Effet secondaire minimal profile par rapport aux traitements traditionnels
• Potentiel pour la qualité de vie des patients à long terme

État du pipeline clinique:

Programme	Étape de développement	Indication cible
Tildacerfont	Essais cliniques de phase 2	Hyperplasie surrénalienne congénitale
Thérapies endocriniennes supplémentaires	Recherche préclinique	46, XY Troubles du développement du sexe

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

Engagement direct avec les professionnels de la santé et les prestataires de soins de santé

Spruce Biosciences cible les maladies endocriniennes rares avec des stratégies de relation client spécialisées:

Type d'engagement	Public cible	Fréquence d'interaction
Sensibilisation médicale directe	Endocrinologues pédiatriques	Réunions scientifiques trimestrielles
Boards consultatifs cliniques	Spécialistes de maladies rares	Consultations bi-annuelles

Programmes de soutien aux patients pour les communautés de maladies rares

• Programme d'aide aux patients dévoués pour les patients congénitaux d'hyperplasie surrénalienne (CAH)
• Ressources de soutien financier pour l'accès aux médicaments
• Matériel d'éducation des patients personnalisés

Initiatives de communication scientifique et médicale

Canaux de communication clés:

Canal	But	Atteindre
Conférences médicales	Présentation de recherche	150+ professionnels de la santé chaque année
Publications évaluées par des pairs	Partage de données cliniques	8-10 publications par an

Reportage des essais cliniques transparents et transparence de la recherche

Métriques de transparence des essais cliniques:

• 100% ClinicalTrials.gov Compliance d'enregistrement
• Résultats en temps opportun signalant dans les 12 mois suivant l'achèvement de l'essai
• Accès ouvert aux données anonymisées des patients

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les spécialistes de l'endocrinologie pédiatrique

Depuis le quatrième trimestre 2023, Spruce Biosciences maintient une force de vente spécialisée de 12 représentants axés exclusivement sur les spécialistes de l'endocrinologie pédiatrique.

Métrique de l'équipe de vente	Données quantitatives
Représentants des ventes totales	12
Couverture géographique	50 États américains
Interactions moyennes spécialisées par mois	87 Engagements directs

Conférences médicales et symposiums scientifiques

Spruce Biosciences participe à des événements médicaux ciblés pour présenter la recherche clinique et les informations sur les produits.

• Conférence annuelle de la Société pédiatrique endocrinienne
• Conférence Endo de la Société endocrine
• Conférence nationale de l'American Academy of Pediatrics

Plateformes numériques pour la diffusion de l'information médicale

Canal numérique	Métriques d'engagement
Site Web de l'entreprise	42 500 visiteurs mensuels uniques
Page professionnelle LinkedIn	3 750 abonnés
Webinaires professionnels médicaux	6 hébergés chaque année

Partenariats avec des groupes de défense des patients

Partenariats collaboratifs actifs:

• Fondation magique pour la croissance des enfants
• Fondation congénitale de la recherche sur la recherche sur les hyperplasie surrénalienne (CARES)
• Programme de sensibilisation des patients de la société endocrinienne pédiatrique

Métrique de partenariat	Données quantitatives
Partenariats totaux de plaidoyer pour les patients	5 collaborations actives
Événements annuels de sensibilisation des patients	12 événements collaboratifs
Matériel d'éducation des patients distribué	87 500 ressources d'information

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: segments de clientèle

Endocrinologues pédiatriques

Taille du marché: environ 1 200 endocrinologues pédiatriques certifiés au conseil d'administration aux États-Unis à partir de 2023.

Caractéristique du segment	Données quantitatives
Spécialistes potentiels totaux	1 200 endocrinologues pédiatriques
La charge de travail annuelle moyenne des patients	75-100 patients atteints de troubles endocriniens
Pénétration estimée du marché	18-22% des spécialistes

Centres de traitement des maladies rares

Complet Overview:

• Total des centres de traitement des maladies rares spécialisées aux États-Unis: 87
• Centres axés sur les troubles endocriniens génétiques: 42
• Budget de recherche annuel par centre: 3,2 millions de dollars - 7,5 millions de dollars

Patients souffrant de troubles endocriniens génétiques spécifiques

Catégorie de troubles	Population estimée des patients
Hyperplasie surrénalienne congénitale (CAH)	20 000 à 30 000 patients aux États-Unis
46, XY Troubles du développement du sexe	1 naissances vivantes sur 20 000

Institutions de recherche

Déchange institutionnelle:

• Institutions de recherche totale en endocrinologie: 156
• Institutions financées par les NIH: 89
• Financement de la recherche annuelle: 412 millions de dollars en recherche sur l'endocrinologie génétique

Mesures clés du marché:

Métrique	Valeur
Marché total adressable	487 millions de dollars
Taux de croissance annuel potentiel	6.3%

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: Structure des coûts

Investissements approfondis de recherche et développement

Au quatrième trimestre 2023, Spruce Biosciences a déclaré des dépenses de R&D de 16,7 millions de dollars pour l'exercice. L'objectif de recherche de l'entreprise se concentre principalement sur des troubles endocriniens pédiatriques rares.

Année	Dépenses de R&D	Pourcentage des dépenses d'exploitation totales
2022	14,3 millions de dollars	78%
2023	16,7 millions de dollars	82%

Dépenses des essais cliniques

Les coûts des essais cliniques pour le candidat principal du médicament à Spruce Biosciences, TildacerFont, représentaient une partie importante de leurs dépenses opérationnelles.

• Coût des essais cliniques de phase 2: environ 7,2 millions de dollars en 2023
• Programmes cliniques de l'hyperplasie surrénalienne congénitale surrénalienne pédiatrique (CAH): 5,5 millions de dollars estimés

Processus de conformité et d'approbation réglementaires

Les dépenses de soumission et de conformité réglementaires pour 2023 ont totalisé environ 2,1 millions de dollars.

Catégorie de conformité	Dépenses estimées
Coûts de soumission de la FDA	1,3 million de dollars
Documentation réglementaire	0,8 million de dollars

Coûts d'acquisition du personnel et des talents scientifiques

Les dépenses de personnel de Spruce Biosciences pour 2023 ont été déclarées à 12,4 millions de dollars.

• Total des employés: 48 au 31 décembre 2023
• Compensation moyenne du personnel scientifique: 215 000 $ par an
• Rémunération des cadres: 1,6 million de dollars

Les dépenses d'exploitation totales de la société pour 2023 étaient de 24,3 millions de dollars, avec des frais de R&D et de personnel comprenant la majorité des dépenses.

Spruce Biosciences, Inc. (SPRB) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Depuis le Q4 2023, Spruce Biosciences se concentre sur le développement de TildacerFont pour l'hyperplasie surrénalienne congénitale (CAH). Les projections potentielles des revenus comprennent:

Drogue	Taille du marché potentiel	Potentiel des revenus annuels estimés
Tildacerfont (CAH)	Environ 5 000 à 7 000 patients aux États-Unis	50 à 80 millions de dollars par an

Financement de recherche collaborative

Les sources de financement de la collaboration de recherche comprennent:

• Subventions des National Institutes of Health (NIH)
• Partenariats de recherche sur les maladies rares
• Collaborations du centre médical académique

Accords de licence potentiels

Structiel potentiel de revenus:

Type de licence	Fourchette de revenus potentiel
Paiements de licence initiale	5-15 millions de dollars
Paiements d'étape	Jusqu'à 100 millions de dollars
Pourcentages de redevances	8 à 12% des ventes nettes

Financement des subventions des institutions de recherche

Données historiques de financement des subventions:

• Les subventions totales du NIH reçues: 2,3 millions de dollars (2022)
• Concessions de recherche sur les maladies rares: 750 000 $ (2023)
• Concessions de partenariat académique: 500 000 $ (2023)

Spruce Biosciences, Inc. (SPRB) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Spruce Biosciences, Inc. (SPRB) exists right now, late in 2025. It's all about delivering novel therapies where the current options are essentially non-existent or purely supportive.

Potential first-to-market therapy for fatal Sanfilippo Syndrome Type B (MPS IIIB)

Spruce Biosciences, Inc. is positioning TA-ERT (tralesinidase alfa enzyme replacement therapy) to be the first disease-modifying therapy for MPS IIIB. This is a critical value proposition because, as of late 2025, there are no FDA-approved therapies for this condition. The disease itself is ultra-rare, affecting an estimated fewer than 1:200,000 people in the United States. For families, this means the potential to move from palliative care to a disease-modifying treatment is the ultimate value.

TA-ERT's Breakthrough Therapy Designation expedites development and review

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TA-ERT on October 6, 2025. This designation is a massive de-risking factor, signaling regulatory support for accelerating development and review. The company is now on track to submit the Biologics License Application (BLA) in the first quarter of 2026. This regulatory momentum is backed by corporate action; Spruce Biosciences, Inc. secured a $50 million private placement financing in October 2025, which, combined with existing cash, is expected to fund the operating plan into the fourth quarter of 2026.

Non-steroidal therapy (Tildacerfont) for rare endocrine disorders (CAH)

While Spruce Biosciences, Inc. has ceased development activities for tildacerfont in Congenital Adrenal Hyperplasia (CAH) as of the third quarter of 2025, the prior work established valuable expertise in non-steroidal approaches for endocrine disorders. The company is now applying insights from that program to its Precision Psychiatry Program. Specifically, topline data for tildacerfont in Major Depressive Disorder (MDD) is anticipated in the first half of 2026 (1H 2026).

Addressing high unmet medical needs in ultra-rare pediatric neurological diseases

The value proposition centers on providing options for conditions where the prognosis is dire. For MPS IIIB, the estimated life expectancy ranges from 15 to 19 years of age. The current standard of care is limited to supportive measures only. Spruce Biosciences, Inc. is targeting this high unmet need with a therapy that has been administered to 22 individuals with MPS IIIB in clinical studies.

Potential for profound and durable clinical impact in MPS IIIB patients

The clinical data supports the BTD, showing a potentially transformative impact. Integrated data from clinical studies spanning up to five years demonstrates efficacy. The therapy showed a significant reduction in the key biomarker, Cerebral Spinal Fluid Heparan Sulfate Non-Reducing End (CSF HS-NRE). At 240 weeks, CSF HS-NRE decreased by 91.5 ng/mL from baseline (with a p-value of <0.0001), and the treatment was associated with stabilized cognition.

Here's a quick look at the program status underpinning these value drivers:

• TA-ERT for MPS IIIB: BLA submission targeted for Q1 2026.
• Tildacerfont for MDD: Phase 2 data anticipated in 1H 2026.
• Q3 2025 Non-GAAP EPS: Loss of $14.58 per share.
• Q3 2025 Revenue: $0.0 million.
• Financing Secured: $50.0 million in October 2025.

The company is focused on delivering a novel option where the disease is fatal and the patient population is small, which often translates to premium pricing potential upon approval, justifying the current investment in R&D, which was $5.0 million for the three months ended September 30, 2025.

Spruce Biosciences, Inc. (SPRB) - Canvas Business Model: Customer Relationships

High-touch engagement with patient advocacy groups for MPS IIIB

Spruce Biosciences, Inc. expressed gratitude to the patient and caregiver advocates who took part in the TA-ERT clinical trials. This engagement supports the development of tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB), a condition with no FDA-approved treatments as of late 2025. The company is focused on pursuing accelerated approval of TA-ERT.

Direct communication with key opinion leaders (KOLs) and specialized physicians

The Chief Executive Officer of Spruce Biosciences, Javier Szwarcberg, M.D., M.P.H., specifically mentioned appreciation for the clinicians and industry leaders who contributed to the TA-ERT program. This direct relationship supports the anticipated Biologics License Application (BLA) submission targeted for the first quarter of 2026.

Managed access programs for TA-ERT prior to potential approval

Spruce Biosciences plans to enable expanded access programs to ensure that patients have access to therapy. This is planned prior to potential accelerated approval of TA-ERT, following the BLA submission.

Investor and analyst outreach following strategic pivots and financing

The company secured significant capital through investor outreach following its strategic pivot to MPS IIIB. The October 2025 private placement resulted in gross proceeds of approximately $50.0 million. This outreach was backed by a syndicate of dedicated healthcare investors.

Financing Metric	Value/Amount	Date/Context
Gross Proceeds from October 2025 Private Placement	$50.0 million	October 2025
Common Shares Purchased in Placement	Approximately 502,181 shares	October 2025
Purchase Price per Share	$68.00 per share	October 2025
Maximum Prefunded Warrants Purchased	Up to 233,144 warrants	October 2025
Cash and Cash Equivalents (Pre-Financing)	$10.7 million	September 30, 2025
Cash Runway Extension	Into the fourth quarter of 2026	Post-Financing Estimate
Q3 2025 Non-GAAP Net Loss Per Share	$14.58	Q3 2025 Results
Recent Stock Decline (Prior to Financing)	Over 27%	Past Month (Pre-October 2025)

The company is also working toward relisting on the Nasdaq Capital Market, contingent upon compliance with the minimum bid price for 20 consecutive trading days, following a reverse stock split effective August 4, 2025. The stock began trading exclusively on the OTC Pink Marketplace on April 29, 2025.

Clinical trial site coordination and patient support

Coordination involves sites across multiple studies that have generated integrated data over a five-year period across three separate clinical trials for TA-ERT. This data supports the FDA granting Breakthrough Therapy Designation.

• TA-ERT efficacy demonstrated stabilization of brain volume and cognitive function.
• The therapy is intended for patients with MPS IIIB who lack rhNAGLU enzyme activity.
• The FDA confirmed that HS-NRE is a surrogate biomarker that may predict clinical benefit.
• The company is focused on submitting the BLA in the first quarter of 2026.

Spruce Biosciences, Inc. (SPRB) - Canvas Business Model: Channels

You're looking at Spruce Biosciences, Inc. (SPRB) right now, and the channels are entirely geared toward a single, high-stakes regulatory event. The company has explicitly stated it has not yet demonstrated an ability to conduct sales and marketing activities necessary for successful commercialization as of May 2025.

The primary channel focus is regulatory clearance for tralesinidase alfa (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB). The company is on track to submit its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the First Quarter of 2026. This submission path is significantly aided by the Breakthrough Therapy Designation (BTD) granted by the FDA on October 6, 2025. This designation facilitates eligibility for rolling submission and priority review, which are critical channels for speed-to-market in ultra-rare diseases.

For the direct sales force targeting specialized treatment centers post-approval, the current operational structure is lean. As of late 2025, Spruce Biosciences has only 25 total employees. The establishment and development of a commercial sales force is an anticipated, expensive, and time-consuming next step following any potential approval.

Academic and medical conferences serve as the channel for data dissemination, though the most significant recent event was the regulatory news itself. The BTD confirmed the FDA's view that the CSF HS-NRE biomarker is reasonably likely to predict clinical benefit.

The capital markets channel has been active, providing the necessary fuel for the regulatory push. Spruce Biosciences secured gross proceeds of approximately $50.0 million from a private placement financing in October 2025. This financing, combined with cash on hand, is projected to fund the current operating plan into the fourth quarter of 2026. Investor presentations and press releases were the vehicles for communicating these milestones, which included the BTD and the financing event.

Patient advocacy networks are an implicit channel, given the focus on MPS IIIB, a devastating pediatric disorder with no approved treatments. The company expressed gratitude to the patients and families who took part in the TA-ERT clinical trials.

Here is a quick look at the financial underpinning supporting these channel activities as of the third quarter of 2025:

Financial/Operational Metric	Value (as of Late 2025)	Context
Cash & Cash Equivalents (as of Sep 30, 2025)	$10.7 million	Pre-October 2025 financing
October 2025 Private Placement Proceeds	$50.0 million	Gross proceeds
Projected Cash Runway	Into the fourth quarter of 2026	Post-financing
Total Employees	25	As of November 2025
Trailing Twelve Month Revenue (TTM)	$697K	As of September 30, 2025
Operating Expenses (9 Months ended Sep 30, 2025)	$25.4 million	Year-to-date spend

The company's immediate channel strategy is heavily weighted toward regulatory success, which then dictates the activation of commercial channels. The recent financing was a crucial step to bridge the gap to the anticipated BLA submission date.

Key channel-related milestones and status points include:

• FDA BTD granted for TA-ERT on October 6, 2025.
• Anticipated BLA submission date for TA-ERT is the First Quarter of 2026.
• The company has no revenue recorded for Q3 2025.
• The prior focus on tildacerfont for CAH has ceased.
• The company executed a 1-for-75 reverse split in August 2025 to maintain Nasdaq compliance.

The path forward for Spruce Biosciences, Inc. channels is clear: secure the BLA approval, then rapidly build out the specialized sales infrastructure necessary to reach the small population of MPS IIIB patients. Finance: finalize the Q4 2025 cash burn projection by Tuesday.

Spruce Biosciences, Inc. (SPRB) - Canvas Business Model: Customer Segments

You're looking at the customer segments for Spruce Biosciences, Inc. (SPRB) as of late 2025. This is a company focused on ultra-rare and serious neurological disorders, so the segments are highly specialized, which is typical for late-stage development in this space.

Pediatric patients with Sanfilippo Syndrome Type B (MPS IIIB)

This is the core patient population for their lead candidate, TA-ERT, which is on track for a Biologics License Application (BLA) submission in the first quarter of 2026 and has received Breakthrough Therapy Designation.

• MPS IIIB affects fewer than 1:200,000 people in the United States.
• It is a fatal disease with an estimated life expectancy ranging from 15 to 19 years.
• Currently, there are no FDA-approved treatments for MPS IIIB.
• TA-ERT has been administered to twenty-two individuals with MPS IIIB across three clinical studies.

Specialized neurologists and metabolic disease specialists

These clinicians are the gatekeepers who diagnose MPS IIIB and would prescribe TA-ERT, especially given its intended intracerebroventricular injection route, which requires specialized centers.

The clinical development focus directly informs their interest:

• TA-ERT demonstrated stabilization of cortical grey matter volume (CGMV) relative to the decline observed in untreated children.
• The therapy is designed to restore enzyme activity in the central nervous system.

Adult patients with Major Depressive Disorder (MDD) (via partner HMNC)

Spruce Biosciences, Inc. has a separate, partnered program for MDD using tildacerfont, which leverages HMNC Holding GmbH's proprietary genetic test, Cortibon, for precision psychiatry.

The market here is vast, but the target is a specific subset:

Metric	Data Point
Global MDD Population	Approximately 300 million people globally
US Adult MDD Prevalence	Approximately 9% of US adults
Treatment Resistance Rate	~15-30% of MDD patients
First-Line Therapy Failure Rate	~30-50% of patients
Phase 2 TAMARIND Trial Data Anticipated	1H 2026

If the Phase 2 proof-of-concept study is positive, Spruce has an option to in-license worldwide rights.

Institutional investors focused on late-stage biotech and rare diseases

This segment is interested in the capital structure, financing milestones, and the potential for accelerated approval, which de-risks the investment profile. You can see their focus in the recent capital raise.

Here's the quick math on recent financial activity:

• Spruce Biosciences, Inc. secured a $50 million private placement financing in October 2025.
• Cash as of September 30, 2025, was $10.7 million; the combined total is expected to fund operations into the fourth quarter of 2026.
• The company reported a net loss of $8.2 million for the three months ended September 30, 2025.
• The stock experienced a surge of over 1361.0% on October 6, 2025, moving from about $8.9 to a peak of $128.86.
• The price-to-book ratio was 0.38 as of the latest filings.

The company executed a 1-for-75 reverse stock split in September 2025 to maintain Nasdaq listing compliance.

Payers and government health agencies for reimbursement

This group is critical for commercial viability, as they determine coverage and reimbursement rates for the eventual therapy. The focus here is on the regulatory pathway and the high unmet need.

Key points for this segment include:

• TA-ERT is targeting accelerated approval based on the surrogate biomarker HS-NRE.
• The company plans to enable expanded access programs prior to potential accelerated approval.
• The FDA granted Breakthrough Therapy Designation for TA-ERT in October 2025.
• The company acknowledges that coverage and reimbursement may be limited or unavailable in certain market segments for TA-ERT.

Finance: draft 13-week cash view by Friday.

Spruce Biosciences, Inc. (SPRB) - Canvas Business Model: Cost Structure

You're looking at the major outflows for Spruce Biosciences, Inc. (SPRB) as they push toward their Biologics License Application (BLA) goal. For a late-stage biopharma outfit like Spruce Biosciences, Inc., the cost structure is dominated by getting that lead asset across the finish line.

Research and Development (R&D) expenses are definitely the biggest driver here. For the nine months ended September 30, 2025, Spruce Biosciences, Inc. reported R&D expenses totaling $15.4 million. This compares to $25.0 million for the same nine-month period in 2024, so you see a reduction, but that doesn't mean less work; it means a shift in focus.

The change in R&D spend reflects strategic decisions about their pipeline programs. The decrease was mainly due to the cessation of development activities of tildacerfont, which was being developed for congenital adrenal hyperplasia (CAH). That cost reduction was offset by ongoing development activities for their lead candidate, tralesinidase alfa enzyme replacement therapy (TA-ERT), which is aimed at treating Sanfilippo Syndrome Type B (MPS IIIB). The clinical trial costs for the TA-ERT program are now the primary R&D expenditure, especially following the receipt of Breakthrough Therapy Designation from the FDA.

Next up are the overheads, the General and Administrative (G&A) expenses. For the nine months ended September 30, 2025, G&A expenses were $10.0 million. This was down from $11.3 million in the first nine months of 2024. Honestly, this reduction was primarily driven by a decrease in stock-based compensation expense across the organization.

Here's a quick look at how those main operating costs stacked up for the nine months ending September 30, 2025:

Cost Category	Amount (Nine Months Ended Sept 30, 2025)
Research and Development (R&D) Expenses	$15.4 million
General and Administrative (G&A) Expenses	$10.0 million
Total Operating Expenses	$25.4 million

When you look deeper into the TA-ERT program, you know that manufacturing and supply chain costs are ramping up as they prepare for a commercial launch, even though specific dollar amounts for this are usually bundled within R&D or Cost of Goods Sold (which isn't detailed here). The focus is on getting the production ready for scale post-approval. Similarly, regulatory filing and compliance costs for the BLA submission, which is on track for the first quarter of 2026, represent a significant, though often lumpy, expense category. These costs include fees paid to the FDA and the internal resources dedicated to compiling the massive data package required for review.

The company secured a $50.0 million private placement financing in October 2025, which, when combined with their cash on hand as of September 30, 2025 ($10.7 million), is expected to fund their operating plan into the fourth quarter of 2026. That financing is what keeps these cost structures running smoothly until potential revenue hits.

Spruce Biosciences, Inc. (SPRB) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Spruce Biosciences, Inc. (SPRB) as of late 2025. Honestly, for a late-stage biotech like SPRB, the revenue streams are less about current sales and more about near-term value inflection points from regulatory milestones and capital markets activity. It's all about funding the path to product sales.

Current Product Revenue

As of the third quarter of 2025, Spruce Biosciences, Inc. reported $0.0 million in product revenue. This is exactly what you'd expect from a company focused on clinical development rather than commercialization. The company's financial reports for the quarter ending September 30, 2025, confirmed this lack of sales revenue, aligning with analyst expectations for a clinical-stage firm. To be fair, the trailing twelve months revenue ending September 30, 2025, was reported as $697.00K, but the current quarter shows zero product sales, which is the key metric when assessing commercial readiness.

Financing Proceeds as a Temporary Revenue Source

The most concrete, recent financial inflow is from equity financing, which provides the necessary operating runway. In October 2025, Spruce Biosciences, Inc. closed a definitive agreement for a significant private placement. This cash is critical to bridge the gap until potential product launch.

Here's the quick math on that October 2025 financing event:

Financing Instrument	Approximate Number of Units/Shares	Purchase Price Per Unit/Share	Total Gross Proceeds (Approximate)
Common Stock	502,181 shares	$68.00	~$34.15 million
Pre-Funded Warrants	Up to 233,144 shares	$67.99	~$15.85 million
Total Gross Proceeds	735,325 (Total Securities)	N/A	$50.0 million

This infusion of approximately $50.0 million in gross proceeds is intended to fund the current operating plan into the fourth quarter of 2026, covering key pre-commercial and regulatory activities.

Future Product Sales of Tralesinidase alfa (TA-ERT)

The primary long-term revenue driver is the potential commercial success of Tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB). This asset has secured several regulatory advantages, including fast-track designation, rare pediatric disease designation, and orphan drug designation in the U.S. and EU. The company is targeting a Biologics License Application (BLA) submission in the first quarter of 2026, with a potential U.S. commercial launch anticipated in late 2026.

If approved, the revenue stream will be driven by:

• Sales of TA-ERT as a potential first-to-market treatment for MPS IIIB.
• The need to build a highly specialized commercial and medical affairs organization to support launch.
• Leveraging regional partnerships and third-party distributors for international markets.

Potential Milestone Payments from the HMNC Tildacerfont Partnership

Spruce Biosciences, Inc. has a collaboration with HMNC Holding GmbH (HMNC) for tildacerfont as a precision treatment for Major Depressive Disorder (MDD). The Phase 2 TAMARIND study, which began dosing in July 2025, is a key event, with topline results expected in the first half of 2026. The revenue potential here is contingent on Spruce exercising its option to in-license worldwide rights following positive results.

Should Spruce exercise this option, the revenue structure includes:

• Certain milestone payments due to HMNC.
• Tiered royalties on future net sales of tildacerfont in MDD.

The actual amounts for these milestones are not publicly disclosed, but their existence forms a defined, contingent revenue stream.

Potential Licensing or Collaboration Revenue for Pipeline Assets

Beyond the two main programs, other pipeline assets represent potential, albeit currently unrealized, revenue. For instance, in the first quarter of 2025, the reported Collaboration revenue stood at $-. This reflects the clinical stage where upfront payments or research funding from collaborations are either minimal or not yet realized for other assets. Any future licensing deals for assets like SPR202, an anti-corticotrophin releasing hormone monoclonal antibody, would create non-dilutive revenue, but as of late 2025, this stream is not material.