Biorestorative Therapies, Inc. (BRTX): Business Model Canvas [Jan-2025 Mis à jour]

Dans le domaine de la pointe de la médecine régénérative, Biorestorative Therapies, Inc. (BRTX) émerge comme une force pionnière, transformant la façon dont nous abordons les maladies chroniques et les thérapies sur les cellules souches. En fabriquant méticuleusement un modèle commercial complet qui prie la recherche innovante, les partenariats stratégiques et les technologies médicales révolutionnaires, le BRTX est sur le point de révolutionner des traitements régénératifs personnalisés. Leur approche unique combine l'expertise scientifique, le développement de la propriété intellectuelle et une stratégie axée sur le laser qui pourrait potentiellement remodeler les interventions médicales pour les patients à la recherche de solutions avancées et non invasives.

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: partenariats clés

Institutions de recherche universitaire axées sur les thérapies sur les cellules souches

Institution	Détails du partenariat	Focus de recherche
École de médecine de l'Université de Miami Miller	Contrat de recherche collaboratif	Thérapies sur les cellules souches de régénération du disque
Université de Californie, San Diego	Protocole de recherche conjoint	Développement thérapeutique cellulaire

Collaborateurs de dispositifs médicaux et de biotechnologie

Les thérapies biorestoratives maintiennent des partenariats stratégiques avec des sociétés de biotechnologie spécialisées:

• Regenerative Technologies Inc.
• Biotechnologies de cellule
• Diagnostics cellulaires avancés

Partenaires potentiels de développement pharmaceutique

Entreprise pharmaceutique	Zone de collaboration potentielle	État actuel
Pfizer Inc.	BRTX-100 Thérapie de cellules souches	Discussions exploratoires
Johnson & Johnson	Recherche de médecine régénérative	Engagement préliminaire

Réseaux de recherche en essai clinique

Partenariats actifs du réseau d'essais cliniques:

• Réseau des essais cliniques des National Institutes of Health (NIH)
• American Association of Neurological Surgeons Research Network
• Consortium international des essais cliniques sur les cellules souches

Investissements totaux de partenariat en 2023: 2,3 millions de dollars

Budget d'extension de partenariat projeté pour 2024: 3,5 millions de dollars

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: activités clés

Développer des thérapies de médecine régénérative

Les thérapies biorestoratives se concentrent sur le développement de traitements innovants en médecine régénérative, en particulier le ciblage:

• BRTX-100 pour la maladie du disque
• Technologie Thermostem® pour les thérapies sur les cellules souches dérivées adipeuses

Thérapie	Étape de développement	Condition cible
BRTX-100	Recherche préclinique	Dégénérescence du disque
Thermostem®	Évaluation clinique précoce	Traitements des cellules souches adipeuses

Effectuer des recherches précliniques et cliniques

Investissement et activités de recherche en 2024:

Métrique de recherche	Valeur
Dépenses de recherche annuelles	1,2 million de dollars
Protocoles de recherche actifs	3 études simultanées

Avançant des technologies de traitement des cellules souches

Le développement de la technologie se concentre sur:

• Techniques de préservation des cellules propriétaires
• Protocoles de différenciation cellulaire avancés
• Plates-formes de cellules souches sensibles thermiques

Développement des brevets et gestion de la propriété intellectuelle

Catégorie IP	Nombre d'actifs
Brevets actifs	7
Demandes de brevet en instance	4

Compliance réglementaire et gestion des essais cliniques

Métriques de la conformité réglementaire:

• Fréquence d'interaction FDA: consultations trimestrielles
• Attribution du budget de conformité: 450 000 $ par an
• Protocoles d'essais cliniques actifs: 2

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: Ressources clés

Technologies de cellules souches propriétaires

Les thérapies biorestoriques tiennent Thermostem ™ Technologie pour les traitements des cellules souches dérivées adipeuses. Depuis 2024, la société a développé deux candidats de produits de cellules souches primaires:

• BRTX-100 pour le traitement de la maladie disque
• BRTX-210 pour les troubles métaboliques

Expertise en recherche et développement

Métrique de R&D	2024 données
Dépenses annuelles de R&D	2,1 millions de dollars
Nombre de projets de recherche actifs	3
Personnel de R&D	8 chercheurs à temps plein

Portefeuille de propriété intellectuelle

Détails du portefeuille de brevets à partir de 2024:

• Brevets totaux: 7
• Demandes de brevet en instance: 3
• Juridictions de brevet: États-Unis, Union européenne

Personnel scientifique et médical spécialisé

Catégorie de personnel	Nombre
Chercheurs de doctorat	5
Médecins	2
Spécialistes de la recherche clinique	3

Infrastructure de laboratoire et de recherche

Spécifications des installations de recherche:

• Espace total de laboratoire: 2 500 pieds carrés
• Lieu: Melville, New York
• Installations de culture cellulaire avancée: 2 chambres dédiées
• Valeur spécialisée de l'équipement: 1,4 million de dollars

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: propositions de valeur

Solutions de médecine régénérative innovante

Les thérapies biorestoratives se concentrent sur le développement de technologies de médecine régénérative avancées ciblant les besoins médicaux non satisfaits. Le produit principal de l'entreprise, BRTX-100, est une thérapie de cellules souches propriétaire ciblant la dégénérescence du disque.

Produit	Étape de développement	Condition cible	Caractéristiques uniques
BRTX-100	Phase d'essai clinique	Maladie du disque chronique	Thérapie de cellules souches dérivé de l'adipose autologue

Traitements potentiels pour la maladie du disque chronique

La proposition de valeur fondamentale de l'entreprise aborde la maladie des disques chroniques, une condition affectant environ 80% des adultes à un moment donné de leur vie.

• Taille estimée du marché pour les traitements de dégénérescence du disque: 5,2 milliards de dollars d'ici 2026
• Les limitations de traitement actuelles comprennent les procédures chirurgicales invasives
• Le BRTX-100 vise à fournir une alternative régénérative non chirurgicale

Approches thérapeutiques avancées

Les thérapies biorestoriques exploitent Recherche de cellules souches de pointe pour développer des solutions thérapeutiques innovantes.

Type de cellule souche	Source	Potentiel thérapeutique
Cellules souches dérivées d'adipose	Tissu adipeux du patient	Capacités de guérison régénératives

Stratégies d'intervention médicale non invasive

L'approche de l'entreprise se concentre sur les traitements régénératifs mini-invasifs qui réduisent le temps de récupération des patients et les risques chirurgicaux.

• Réduction du temps de récupération des patients par rapport aux interventions chirurgicales traditionnelles
• Complications chirurgicales minimisées
• Potentiel de protocoles de traitement ambulatoire

Traitements médicaux régénératifs personnalisés

Les thérapies biorestoratives met l'accent sur la médecine personnalisée par des thérapies sur les cellules souches spécifiques du patient.

Aspect de personnalisation	Avantage	Mise en œuvre
Approche de cellules souches autologues	Rejet immunitaire réduit	Récolte des cellules souches dérivées du patient

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

En 2024, les thérapies biorestoriques entretiennent des stratégies de sensibilisation ciblées avec des professionnels de la santé spécialisés en médecine régénérative et en thérapies sur les cellules souches.

Canal de fiançailles	Fréquence d'interaction	Target Specialties
Présentations de la conférence médicale	4-6 conférences par an	Orthopédie, neurologie, gestion de la douleur
Consultations de vente directe	72 consultations prévues par trimestre	Centres de traitement spécialisés

Services de soutien aux patients et de consultation

Les thérapies biorestoratives fournissent des mécanismes complets de soutien aux patients.

• Aide à la patiente dédiée: (888) 555-BRTX
• Portail de patients en ligne avec suivi du traitement
• Série de webinaires mensuels sur la thérapie par cellules souches

Communication scientifique

Biorestorative maintient des protocoles de communication scientifique rigoureux.

Méthode de communication	Fréquence	Plates-formes
Publication évaluée par des pairs	2-3 publications par an	Journal of Regenerative Medicine
Participation du symposium de recherche	3 symposiums internationaux par an	Réseaux de recherche sur les cellules souches mondiales

Interactions des participants aux essais cliniques

Biorestorative gère l'engagement des participants à essais cliniques structurés.

• Essais cliniques actifs actuels: 3 études en cours
• Total des participants inscrits: 87 patients
• Fréquence de communication des participants: mises à jour bihebdomadaires

Communication de recherche transparente

La société priorise la communication transparente des progrès de la recherche et des résultats.

Canal de communication	Fréquence de divulgation	Type d'information
Site Web de relations avec les investisseurs	Mises à jour trimestrielles	Jalons de recherche, résultats préliminaires
Dépôts de la SEC	Rapports trimestriels et annuels	Recherche détaillée et divulgations financières

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: canaux

Conférences médicales et symposiums

Les thérapies biorestoratives utilisent des conférences médicales comme canal clé pour la communication scientifique et le développement potentiel de partenariat. En 2023, l'entreprise a participé à 4 grandes conférences de médecine régénérative.

Nom de conférence	Date	Emplacement	Participants
Conférence internationale en médecine régénérative	Mai 2023	Boston, MA	1,200
Symposium de recherche sur les cellules souches	Septembre 2023	San Diego, CA	950

Publications scientifiques

La société maintient une stratégie de publication scientifique active pour communiquer les résultats de la recherche.

• Publié 3 articles à comité de lecture en 2023
• Total des citations: 42
• Facteur d'impact des publications: 4.7

Ventes directes aux institutions médicales

Les thérapies biorestoratives utilisent une approche de vente directe ciblée des établissements de recherche médicale.

Type d'institution	Nombre d'institutions contactées	Taux de conversion
Centres de recherche universitaires	22	18%
Institutions de recherche privées	15	12%

Plateformes de communication scientifique en ligne

Les canaux numériques sont essentiels pour la communication scientifique et la visibilité.

• Site Web Visiteurs uniques en 2023: 45 670
• LinkedIn adepte: 3200
• Taux d'engagement de la plate-forme scientifique: 6,3%

Communications des relations avec les investisseurs

La communication avec les investisseurs est maintenue via plusieurs canaux.

Canal de communication	Fréquence	Atteindre
Appels de résultats trimestriels	4 fois par an	150 investisseurs institutionnels
Réunion des actionnaires annuelle	Une fois par an	250 participants
Webinaires de présentation des investisseurs	6 fois par an	500 participants au total

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: segments de clientèle

Des médecins spécialistes orthopédiques

Taille du marché cible: environ 30 000 chirurgiens orthopédiques aux États-Unis à partir de 2023.

Caractéristiques du segment	Pénétration du marché
Spécialistes de la chirurgie de la colonne vertébrale	Estimé 12 500 pratiquants
Médecine sportive orthopédistes	Environ 3 800 spécialistes

Patients atteints de maladie du disque chronique

Population totale de patients: 16 millions d'Américains ont diagnostiqué des conditions chroniques liées au disque.

• Tranche d'âge: 35 à 65 ans
• Traitement annuel à la recherche de patients: estimé 2,5 millions
• Valeur marchande potentielle: 8,3 milliards de dollars de possibilités de traitement régénératives

Institutions de recherche

Type d'institution	Nombre de clients potentiels
Centres de recherche universitaires	289 grandes institutions de recherche médicale
Installations de recherche en biotechnologie	127 laboratoires spécialisés en médecine régénérative

Investisseurs en biotechnologie

Répartition du segment des investisseurs:

• Cirmités de capital-risque spécialisés dans les technologies médicales: 42
• Investisseurs institutionnels axés sur la biotechnologie: 86
• Capital d'investissement potentiel total: 1,2 milliard de dollars d'investissements en médecine régénérative

Fournisseurs de soins de santé spécialisés en médecine régénérative

Catégorie de prestataires	Total des praticiens
Cliniques de médecine régénérative	523 installations spécialisées
Centres de traitement complets	213 centres de médecine régénérative multi-spécialités

Valeur marchande totale adressable: 12,5 milliards de dollars en traitements et recherche en médecine régénérative

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, les thérapies biorestoriques ont déclaré des dépenses totales de R&D de 1 845 000 $.

Catégorie de dépenses de R&D	Montant ($)
Recherche de technologie des cellules souches	872,000
BRTX-100 Développement	563,000
Équipement de laboratoire	410,000

Financement des essais cliniques

Les dépenses d'essai cliniques pour 2023 ont totalisé 2 315 000 $, allouées à plusieurs programmes de recherche.

Programme d'essais cliniques	Montant de financement ($)
Procès de régénération du disque	1,200,000
Études sur les conditions inflammatoires	765,000
Recrutement de patients	350,000

Maintenance de la propriété intellectuelle

Les coûts de propriété intellectuelle pour 2023 étaient de 215 000 $.

• Frais de dépôt de brevets: 95 000 $
• Consultation juridique: 75 000 $
• Gestion de la propriété intellectuelle: 45 000 $

Personnel et rémunération du personnel scientifique

Le total des dépenses du personnel pour 2023 s'élevait à 3 642 000 $.

Catégorie du personnel	Compensation totale ($)
Personnel scientifique	2,100,000
Chercheurs de recherche	842,000
Personnel administratif	700,000

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 étaient de 425 000 $.

• Préparation de la soumission de la FDA: 185 000 $
• Conseil de conformité: 140 000 $
• Documentation réglementaire: 100 000 $

Structure totale des coûts pour 2023: 8 442 000 $

Biorestorative Therapies, Inc. (BRTX) - Modèle d'entreprise: Strots de revenus

Licence potentielle de produits thérapeutiques

Depuis le quatrième trimestre 2023, les thérapies biorestoratives se sont concentrées sur les possibilités de licence potentielles pour ses technologies de base:

Technologie	Valeur de licence potentielle	État actuel
BRTX-100 (régénération du disque)	Frais de licence initiale de 2,5 millions de dollars	Étape préclinique
Plateforme de thérapie cellulaire Therapure®	1,8 million de dollars de potentiel de licence estimé	Étape de développement

Subventions de recherche

Sources de financement de subventions de recherche pour 2023-2024:

• GRANTIF POCENTIFSE NATIONAL DE SANTÉ DE SANTÉ (NIH): 450 000 $
• GRANTIF DE RECHERCHE DE MÉDICINE RÉGÉRATIFS DE DÉPARTEMENT: 375 000 $
• Support de la Fondation de recherche privée: 250 000 $

Future commercialisation des produits

Strots de revenus projetés à partir de la commercialisation potentielle des produits:

Produit	Potentiel de marché estimé	Année de lancement prévu
BRTX-100 Traitement thérapeutique	Potentiel de première année de 12,5 millions de dollars	2025
Thérapie cellulaire Therapure®	Potentiel de première année de 8,3 millions de dollars	2026

Accords de partenariat stratégique

Répartition des revenus de partenariat stratégique actuel et potentiel:

• Valeur de collaboration de recherche existante: 675 000 $
• Négociations potentielles de partenariat potentiel: 1,2 million de dollars
• Biotechnology Alliance Exploration: 950 000 $

Paiements de jalons potentiels à partir de collaborations

Structure de paiement d'étape prévue:

Catégorie d'étape	Fourchette de paiement potentielle	Probabilité
Développement préclinique	$500,000 - $750,000	75%
Initiation des essais cliniques	1,1 million de dollars - 1,5 million de dollars	60%
Jalon d'approbation réglementaire	2,5 millions de dollars - 3,2 millions de dollars	40%

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Value Propositions

Non-surgical, autologous cell therapy for chronic disc pain (BRTX-100)

The value proposition centers on BRTX-100, an autologous mesenchymal stem cell therapy for chronic lumbar disc disease (cLDD) delivered via intradiscal injection. The Phase 2 clinical trial (NCT04042844) is designed to enroll up to 99 patients across up to 16 study sites in the United States, with subjects randomized 2:1 to receive BRTX-100 or placebo. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to this program in February 2025. Preliminary blinded data presented at ISSCR 2025, involving 36 evaluated subjects, showed compelling efficacy signals: over 74% experienced greater than 50% improvement in function (ODI) by 52 weeks, and over 72% reported greater than 50% reduction in pain (VAS) by 52 weeks. Earlier data from 15 patients indicated 100% (n=5 at 52 weeks) achieved a greater than 30% improvement in VAS score at 52 weeks posttreatment. The company also obtained FDA Investigational New Drug (IND) clearance to evaluate BRTX-100 for chronic cervical discogenic pain.

Potential cell-based alternative for obesity/metabolic disorders (ThermoStem®)

The ThermoStem® platform offers a cell-based therapeutic candidate targeting obesity and metabolic disorders, utilizing brown adipose (fat) derived stem cells (BADSC) or exosomes secreted by BADSC to generate brown adipose tissue (BAT). This approach is positioned to potentially offer longer-lasting efficacy with improved safety and dosing advantages compared to GLP-1 drugs. In October 2025, the Japanese Patent Office issued a Notice of Allowance for the company's allogeneic, off-the-shelf BADSC technology. Substantive licensing discussions for this intellectual property are continuing.

BioCosmeceutical products for aesthetic practices

BioRestorative Therapies, Inc. operates a commercial BioCosmeceutical platform, which is a near-term revenue focus, targeting what management views as a $63 billion market. The current commercial product is a cell-based secretome containing exosomes, proteins, and growth factors, manufactured in a cGMP ISO-7 certified clean room. Revenue from this segment is subject to order timing; for example, Q3 2025 revenues were $11,800 (entirely royalty revenue), down from $233,600 in Q3 2024 due to order timing. However, Q2 2025 revenues reached approximately $303,000, a 240% increase over Q2-2024, primarily from sales under the exclusive supply agreement with Cartessa Aesthetics, LLC.

Reduced risk profile due to autologous cell source (BRTX-100)

The autologous nature of BRTX-100, using the patient's own cells, contributes to a favorable safety profile. Clinical data presented in 2025 showed no serious adverse events (SAEs) or dose-limiting toxicity reported at the target dose of 40 million cells between 26 and 104 weeks post-injection across evaluated subjects. The company ended Q3 2025 with $4.5 million in cash, cash equivalents, and marketable securities, with no debt, and subsequently closed a $1.1 million financing. The company has a current ratio of 1.37. Despite this, financial efficiency metrics show a Return on Equity (ROE) of -207.73% and an Altman Z-Score of -47.37, which suggests an increased risk of bankruptcy.

Key Financial and Operational Metrics as of Late 2025

Metric Category	Specific Data Point	Value/Amount
Clinical Trial (BRTX-100)	Total Planned Enrollment (Phase 2)	Up to 99 subjects
Clinical Trial (BRTX-100)	Number of U.S. Study Sites	Up to 16
Clinical Trial (BRTX-100)	Reported Subjects Evaluated (ISSCR 2025)	36
Clinical Trial (BRTX-100)	% Subjects with >50% Function Improvement (52 Weeks)	Over 74%
Clinical Trial (BRTX-100)	Dose Tested (Cells)	40 million cells
Financial (Q3 2025)	Revenue	$11,800
Financial (Q3 2025)	Net Loss per Share	$0.33
Financial (Q3 2025 End)	Cash and Marketable Securities	$4.5 million
Financial (Post Q3 2025)	Financing Closed	$1.1 million
Financial (Late 2025)	Market Capitalization	$9.5M (per one source) or $10.23 million (per another)
Financial Efficiency	Return on Equity (ROE)	-207.73%
Operational	Fulltime Employees	11

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Customer Relationships

High-touch scientific engagement with clinical investigators

The relationship with clinical investigators is central to the development of the lead candidate, BRTX-100, for chronic lumbar disc disease (cLDD).

• The Phase 2 clinical trial for BRTX-100 is being conducted across up to 16 clinical sites in the United States.
• Preliminary blinded data from the first 15 patients was presented at the ISCT 2025 Annual Meeting in May 2025.
• By the second quarter of 2025, preliminary blinded data from the first 36 subjects was shared at the ISSCR 2025 Annual Meeting.
• Subjects in the Phase 2 trial are randomized in a 2:1 ratio to receive either BRTX-100 or placebo.

Partner-managed commercial relationship for BioCosmeceuticals

The commercial relationship for the BioCosmeceuticals platform is currently managed through an exclusive supply agreement, though the company is shifting focus to royalty revenue and internal commercial build-out.

Metric	Q3 2025 Amount	Q3 2024 Amount
Total Revenues	$11,800	$233,600
Primary Revenue Source	Exclusively royalty revenue	Primarily BioCosmeceutical sales
Q2 2025 Revenue (for context)	N/A	Approx. $303,000 (primarily BioCosmeceutical sales)

The company appointed Crystal Romano as Global Head of Commercial Operations in October 2025 to accelerate growth beyond the existing partnership structure. The Q3 2025 revenue of $11,800 consisted entirely of royalty revenue, compared to Q3 2024 where the vast majority of revenue came from sales under the exclusive supply agreement with Cartessa Aesthetics, LLC.

Active investor relations via conference calls and presentations

BioRestorative Therapies, Inc. maintains active communication with its investor base through scheduled financial updates and participation in industry events.

• Management hosted conference calls to review financial results for Q1 2025 on May 14, Q2 2025 on August 12, and Q3 2025 on November 12.
• Investor conference calls use the domestic dial-in number 888-506-0062 and international number 973-528-0011.
• CEO Lance Alstodt participated in the Benzinga All-Access Show in April 2025.
• In October 2025, the CEO and VP of Research and Development participated in a panel at the 2025 Maxim Growth Summit.

Regulatory dialogue with the FDA for BLA approval pathway

The relationship with the U.S. Food and Drug Administration (FDA) is focused on advancing the BRTX-100 program toward potential accelerated approval.

The FDA granted Fast Track designation to the BRTX-100 Phase 2 clinical trial in February 2025.

BioRestorative Therapies, Inc. secured a Type B meeting with the FDA scheduled for mid-December 2025 to discuss an accelerated Biologics License Application (BLA) approval pathway for BRTX-100 in cLDD.

The FDA has established performance benchmarks for the trial, requiring at least a greater than 30% improvement in function in the Oswestry Disability Index (ODI) and a greater than 30% reduction.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Channels

You're looking at how BioRestorative Therapies, Inc. (BRTX) gets its science and its commercial products in front of the right people. For a clinical-stage company, the channels are split between proving the science and building the future revenue base.

Clinical trial sites for BRTX-100 patient enrollment and treatment

The primary channel for the lead candidate, BRTX-100, is the Phase 2 clinical trial for chronic lumbar disc disease (cLDD). This channel is critical for generating the data needed for regulatory submission and eventual commercialization. The structure is highly controlled and site-dependent.

The Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial. The total target enrollment is up to 99 eligible subjects, randomized in a 2:1 fashion to receive either BRTX-100 or placebo via a single intradiscal injection. Enrollment is managed across up to 16 clinical sites in the United States. As of November 2025, the company believed enrollment was nearing completion.

Here's a snapshot of the trial's progress and data dissemination through this channel:

Metric/Event	Value/Date	Channel Relevance
Total Target Enrollment	99 subjects	Defines the scale of the clinical channel.
Number of U.S. Clinical Sites	Up to 16	Geographic reach for patient recruitment.
Reported Evaluated Subjects (June 2025)	36	Data point presented at ISSCR 2025.
Reported Initial Patients (Feb 2025)	15 (up from 10)	Early data point shared at ORS 2025.
Randomization Ratio	2:1 (BRTX-100:Placebo)	Study design channel for efficacy measurement.

The FDA has granted Fast Track designation to the BRTX-100 program, which influences the regulatory pathway channel, anticipating a Type B meeting to discuss an accelerated Biologics License Application (BLA) approval pathway.

Strategic commercial partner's sales network (Cartessa Aesthetics)

For the BioCosmeceutical platform, the channel is an exclusive, five-year supply agreement with Cartessa Aesthetics, LLC. This leverages their established North American aesthetics market reach for BioRestorative Therapies, Inc.'s commercial product, Chronos ExoCR. This product is a private label cell-based secretome.

The financial performance through this channel shows variability:

• Q2 2025 revenues were approximately $303,000, representing a 240% increase over Q2-2024, primarily from BioCosmeceutical sales via Cartessa Aesthetics.
• Q3 2025 revenues dropped to approximately $11,800, consisting exclusively of royalty revenue related to BRTX-100 technology, compared to $233,600 in Q3-2024 from BioCosmeceutical sales.

This partnership is intended to introduce the product, which includes a secretome of exosomes, proteins, and growth factors, to aesthetic providers. The companies may explore expanding this collaboration to include additional cell-based biologic products.

Scientific and medical conferences (e.g., ISSCR 2025)

Conferences serve as a vital channel to communicate clinical progress directly to the scientific community, key opinion leaders, and potential investors. BioRestorative Therapies, Inc. actively presents its data at major industry events.

Key conference channel activity in 2025 included:

• ISSCR 2025 Annual Meeting in Hong Kong (June 11 - June 14, 2025), where preliminary blinded data from 30 patients was presented on June 13, 2025.
• ISCT 2025 Annual Meeting in New Orleans, LA (May 7 - May 10, 2025), where an update on the Phase 2 trial was presented.
• ORS 2025 Annual Meeting in Phoenix, AZ (February 7-11, 2025), where 26-52 week blinded data from the first 15 patients was presented.

The presentation at ISSCR 2025 highlighted that over 74% of participants experienced greater than 50% improvement in function, and over 72% reported a similar reduction in pain after 52 weeks, based on data from 36 evaluated subjects.

Direct-to-investor communications and SEC filings

This channel involves formal regulatory disclosures and direct engagement with the investment community, often tied to financial milestones. The company uses press releases, conference calls, and SEC filings to manage investor expectations.

Key investor communication events and financial data points from 2025:

Communication Type	Date	Key Financial/Operational Data Point
Q2 2025 Results Conference Call	August 12, 2025	Company ended Q2 2025 with $7.4 million in cash, cash equivalents, and marketable securities.
Q3 2025 Results Conference Call	November 12, 2025	Q3 2025 loss from operations was $3.7 million; net loss was $3.0 million, or $0.33 per share.
SEC Filing (Form 8-K)	August 12, 2025	Furnished press release announcing Q2 2025 results.
Financing Activity (October 2025)	Subsequent to Q3 End	Sold 678,125 shares at $1.60 per share in a registered direct offering.
Cash Position (End of Q3 2025)	September 30, 2025	Ended quarter with $4.5 million in cash, cash equivalents, and investments, with no outstanding debt.

The company also held its Annual Meeting of Stockholders on September 18, 2025, another direct channel for governance communication.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Customer Segments

You're hiring before product-market fit in the clinical pipeline, so understanding the distinct customer groups BioRestorative Therapies, Inc. (BRTX) serves across its three main areas-clinical development and commercial-is key to valuing the enterprise.

Patients with chronic lumbar disc disease (cLDD)

This segment is the primary focus for the lead clinical candidate, BRTX-100. The treatment is intended for patients whose pain hasn't improved with non-invasive methods and who might otherwise face surgery. The Phase 2 clinical trial for cLDD is nearing completion of enrollment. The trial is designed to enroll up to 99 subjects across up to 16 clinical sites in the United States. As of June 13, 2025, 36 subjects had been evaluated. Preliminary blinded data presented in June 2025 showed encouraging efficacy signals: over 74% of subjects demonstrated a greater than 50% improvement in function (ODI) by 52 weeks, and over 72% reported a greater than 50% reduction in pain (VAS) by 52 weeks. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to this program. The FDA's threshold for determining progression toward Biologics License Application (BLA) approval is a greater than 30% improvement in function (ODI) and a greater than 30% reduction in pain (VAS). The pathway to a potential accelerated BLA has never been more visible.

Patients with chronic cervical discogenic pain (cCDP)

This represents a secondary, but important, patient segment for the BRTX-100 program. BioRestorative Therapies, Inc. has obtained U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to evaluate BRTX-100 specifically for the treatment of chronic cervical discogenic pain. This clearance opens the door to a new patient population for the spine program.

Aesthetic clinics and medical spas (BioCosmeceutical buyers)

This group drives the current commercial revenue stream through the purchase of the BioCosmeceutical platform products, which are proprietary biologic serums engineered to reduce the appearance of fine lines and wrinkles. The company is focused on aggressively executing its near-term revenue strategy within this platform. To accelerate growth, Crystal Romano, an executive with 20 years of leadership in the aesthetics industry, was appointed Head of Global Commercial Operations in October 2025. Revenue from this segment has shown variability based on order timing.

Here's a look at the recent revenue performance, which is primarily driven by these commercial sales, though Q3 2025 revenue was entirely royalty-based:

Reporting Period End Date	Reported Revenue	Primary Revenue Source
September 30, 2025 (Q3 2025)	Approximately $11,800	Royalty Revenue (BRTX-100 Technology)
June 30, 2025 (Q2 2025)	Approximately $303,000	BioCosmeceutical Sales (Cartessa Agreement)
March 31, 2025 (Q1 2025)	$25,000	BioCosmeceutical Sales
September 30, 2024 (Q3 2024)	$233,600	BioCosmeceutical Sales (Cartessa Agreement)

The year-over-year decrease in Q3 2025 revenue compared to Q3 2024 was related to the specific timing of orders for the developing BioCosmeceutical stream.

Pharmaceutical and biotech companies (potential ThermoStem® licensees)

This segment represents a major potential value inflection point through licensing the ThermoStem® platform, which targets obesity and metabolic disorders. The global obesity market is projected to exceed $100 billion annually by the end of the decade. BioRestorative Therapies, Inc. is in active, ongoing negotiations with an undisclosed commercial-stage regenerative medicine company regarding a license for this metabolic disease platform. The intellectual property supporting this platform is well-protected; in October 2025, the Japanese Patent Office issued a Notice of Allowance for a broad patent covering the allogeneic brown adipose-derived stem cell (BADSC) technology. The company ended the third quarter of 2025 with $4.5 million in cash, cash equivalents, and marketable securities, with no outstanding debt, following a financing in October 2025 that brought in gross proceeds of approximately $1.085 million from the sale of 678,125 shares at $1.60 per share.

The key customer characteristics for this segment include:

• Engagement with a commercial-stage regenerative medicine company.
• Interest driven by the potential for a cell-based alternative to chronic GLP-1 injections.
• Value proposition centered on mitigating tolerability issues like muscle mass loss.
• IP protection across U.S. and international markets, evidenced by the Japanese patent allowance.

The company is actively managing resources to advance clinical trials while pursuing this licensing opportunity.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Cost Structure

You're hiring before product-market fit in a highly regulated space; that means your cost structure is dominated by science and compliance, not sales.

Significant R&D and clinical trial expenses are the primary cost drivers for BioRestorative Therapies, Inc. These costs fund the development of their cell-based therapies, particularly the BRTX-100 program for disc/spine disorders. The company's focus on clinical advancement means these expenditures are substantial relative to revenue.

Personnel costs for scientific and executive teams are embedded heavily within both Research and Development and General and Administrative expenses. The recruitment of specialized talent, like the serial regenerative medicine entrepreneur in a new strategic role in June 2025, adds to this fixed cost base. Honestly, keeping the scientific team fully staffed while advancing trials is a non-negotiable burn rate.

Manufacturing and laboratory operations overhead includes costs associated with maintaining cGMP ISO-7 certified clean room facilities for the BioCosmeceutical platform. BioRestorative Therapies, Inc. emphasizes its 'made-in-America' production strategy, which is intended to help manage costs amid global supply chain shifts, but this still requires significant infrastructure investment.

Legal and regulatory compliance costs are a persistent overhead in the regenerative medicine sector. These expenses cover everything from intellectual property portfolio expansion to filings and adherence to FDA guidelines for clinical programs.

The third quarter of 2025 loss from operations was $3.7 million compared to $2.3 million for the comparable period of 2024. Here's the quick math on the most recent detailed quarterly operating expenses available, which were for the three months ended June 30, 2025, as the specific Q3 2025 breakdown isn't fully itemized in the same way:

Expense Category (3 Months Ended June 30, 2025)	Amount (USD)
Research and development	$2,225,882
General and administrative	$1,373,976
Total Operating Expenses (Q2 2025)	$3,599,858
Loss From Operations (Q3 2025)	$3,700,000
Loss From Operations (Q3 2024)	$2,300,000

The cost structure is clearly weighted toward future value creation, which is typical for a clinical-stage biotech. Still, you need to watch the cash burn rate closely.

• Q3 2025 Loss from Operations: $3.7 million
• Q2 2025 Research and Development: $2,225,882
• Q2 2025 General and Administrative: $1,373,976
• Cash, cash equivalents, and investments as of September 30, 2025: $4.5 million
• Authorized stock repurchase program limit: $2 million

Finance: draft 13-week cash view by Friday.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of BioRestorative Therapies, Inc. (BRTX) as of late 2025, and honestly, the picture is one of transition, leaning heavily on early-stage commercial efforts while financing future clinical work. The streams are clearly segmented between near-term product sales and longer-term technology monetization.

The most immediate, though currently small, revenue component is from BioCosmeceutical product sales. This stream is tied to the exclusive supply agreement with Cartessa Aesthetics, LLC. To give you a sense of scale from the prior period, the revenue from these BioCosmeceuticals was the primary driver in Q3-2024, totaling $233,600 for that quarter. The timing of orders for this developing stream impacted the most recent results.

The second established revenue component is Royalty revenue related to BRTX-100 technology. For the third quarter ended September 30, 2025, the total reported revenue was approximately $11,800. What this estimate hides is that this entire amount consisted exclusively of this royalty revenue. So, for Q3 2025, the royalty stream was the only active revenue generator reported.

Future revenue potential is heavily weighted toward clinical program milestones and licensing. Specifically, the ThermoStem® program is a key area where BioRestorative Therapies, Inc. is actively pursuing licensing and partnership deals with commercial-stage regenerative medical companies. These deals would unlock future milestone payments and potential ongoing licensing fees, which are critical for funding the clinical-stage programs like BRTX-100.

To support the ongoing operations and clinical advancement, the company has also recently accessed capital through equity financing. Following the end of the third quarter, BioRestorative Therapies, Inc. completed a financing round, bringing in approximate gross proceeds of $1.085 million. This strengthens the balance sheet to execute on near-term milestones.

Here's a quick look at the key revenue-related financial data points we have for the period:

Revenue Stream Component	Most Recent Reported Value/Context	Period/Date
Q3 2025 Total Revenue	$11,800	Q3 2025
Q3 2025 Royalty Revenue (BRTX-100)	$11,800 (100% of total revenue)	Q3 2025
BioCosmeceutical Sales Context	$233,600 (Primary source in prior period)	Q3 2024
Post-Q3 2025 Equity Financing Proceeds	$1.085 million (Gross proceeds)	Post Q3 2025

The company's focus remains on driving the BioCosmeceutical commercial platform while advancing clinical programs. The revenue breakdown shows a current reliance on the royalty stream while waiting for the next inflection point from licensing or BioCosmeceutical order timing.

• BioCosmeceutical sales are the near-term commercial engine.
• Royalty revenue from BRTX-100 technology was the sole reported revenue source for Q3 2025.
• Future revenue hinges on ThermoStem® licensing and milestone payments.
• Financing provided approximately $1.085 million in gross proceeds after the quarter closed.

Finance: draft 13-week cash view by Friday.