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

Im hochmodernen Bereich der regenerativen Medizin erweist sich BioRestorative Therapies, Inc. (BRTX) als Pionier und verändert die Art und Weise, wie wir chronische Bandscheibenerkrankungen und Stammzelltherapeutika angehen. Durch die sorgfältige Entwicklung eines umfassenden Geschäftsmodells, das innovative Forschung, strategische Partnerschaften und bahnbrechende medizinische Technologien verbindet, ist BRTX bereit, personalisierte regenerative Behandlungen zu revolutionieren. Ihr einzigartiger Ansatz kombiniert wissenschaftliche Expertise, Entwicklung geistigen Eigentums und eine laserfokussierte Strategie, die möglicherweise medizinische Eingriffe für Patienten, die fortschrittliche, nicht-invasive Lösungen suchen, neu gestalten könnte.

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Wichtige Partnerschaften

Akademische Forschungseinrichtungen mit Schwerpunkt auf Stammzelltherapien

Institution	Einzelheiten zur Partnerschaft	Forschungsschwerpunkt
Miller School of Medicine der Universität Miami	Forschungskooperationsvereinbarung	Stammzelltherapien zur Bandscheibenregeneration
Universität von Kalifornien, San Diego	Gemeinsames Forschungsprotokoll	Zelltherapeutische Entwicklung

Mitarbeiter im Bereich Medizintechnik und Biotechnologie

BioRestorative Therapies unterhält strategische Partnerschaften mit spezialisierten Biotechnologieunternehmen:

• Regenerative Technologien Inc.
• CellMark Biotechnologies
• Erweiterte Zelldiagnostik

Potenzielle pharmazeutische Entwicklungspartner

Pharmaunternehmen	Möglicher Kooperationsbereich	Aktueller Status
Pfizer Inc.	BRTX-100-Stammzelltherapie	Sondierungsgespräche
Johnson & Johnson	Forschung zur Regenerativen Medizin	Vorläufiges Engagement

Forschungsnetzwerke für klinische Studien

Aktive Netzwerkpartnerschaften für klinische Studien:

• Netzwerk für klinische Studien der National Institutes of Health (NIH).
• Forschungsnetzwerk der American Association of Neurological Surgeons
• Internationales Konsortium für klinische Stammzellstudien

Gesamtinvestitionen der Partnerschaft im Jahr 2023: 2,3 Millionen US-Dollar

Geplantes Budget für die Erweiterung der Partnerschaft für 2024: 3,5 Millionen US-Dollar

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Hauptaktivitäten

Entwicklung regenerativer medizinischer Therapien

BioRestorative Therapies konzentriert sich auf die Entwicklung innovativer regenerativer medizinischer Behandlungen und zielt insbesondere auf Folgendes ab:

• BRTX-100 bei Bandscheibenerkrankungen
• ThermoStem®-Technologie für Therapien mit Stammzellen aus Fettgewebe

Therapie	Entwicklungsphase	Zielbedingung
BRTX-100	Präklinische Forschung	Bandscheibendegeneration
ThermoStem®	Frühe klinische Bewertung	Behandlungen mit Fettstammzellen

Durchführung präklinischer und klinischer Forschung

Forschungsinvestitionen und -aktivitäten ab 2024:

Forschungsmetrik	Wert
Jährliche Forschungsausgaben	1,2 Millionen US-Dollar
Aktive Forschungsprotokolle	3 gleichzeitige Studien

Weiterentwicklung der Stammzellbehandlungstechnologien

Die Technologieentwicklung konzentriert sich auf:

• Proprietäre Zellkonservierungstechniken
• Erweiterte Protokolle zur Zelldifferenzierung
• Auf Wärme reagierende Stammzellplattformen

Patententwicklung und geistiges Eigentumsmanagement

IP-Kategorie	Anzahl der Vermögenswerte
Aktive Patente	7
Ausstehende Patentanmeldungen	4

Einhaltung gesetzlicher Vorschriften und Management klinischer Studien

Kennzahlen zur Einhaltung gesetzlicher Vorschriften:

• Häufigkeit der Interaktion mit der FDA: Vierteljährliche Konsultationen
• Zuweisung des Compliance-Budgets: 450.000 US-Dollar pro Jahr
• Aktive klinische Studienprotokolle: 2

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Stammzelltechnologien

BioRestorative Therapies hält ThermoStem™ Technologie für die Behandlung von Stammzellen aus Fettgewebe. Bis 2024 hat das Unternehmen zwei primäre Produktkandidaten für Stammzellen entwickelt:

• BRTX-100 zur Behandlung von Bandscheibenerkrankungen
• BRTX-210 bei Stoffwechselstörungen

Forschungs- und Entwicklungskompetenz

F&E-Metrik	Daten für 2024
Jährliche F&E-Ausgaben	2,1 Millionen US-Dollar
Anzahl aktiver Forschungsprojekte	3
F&E-Personal	8 Vollzeitforscher

Portfolio für geistiges Eigentum

Details zum Patentportfolio ab 2024:

• Gesamtzahl der Patente: 7
• Ausstehende Patentanmeldungen: 3
• Patentgerichte: Vereinigte Staaten, Europäische Union

Spezialisiertes wissenschaftliches und medizinisches Personal

Personalkategorie	Nummer
Doktoranden	5
Ärzte	2
Spezialisten für klinische Forschung	3

Labor- und Forschungsinfrastruktur

Spezifikationen der Forschungseinrichtung:

• Gesamtlaborfläche: 2.500 Quadratmeter
• Standort: Melville, New York
• Erweiterte Zellkultureinrichtungen: 2 spezielle Räume
• Wert der Spezialausrüstung: 1,4 Millionen US-Dollar

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Wertversprechen

Innovative Lösungen für die regenerative Medizin

BioRestorative Therapies konzentriert sich auf die Entwicklung fortschrittlicher regenerativer Medizintechnologien, die auf ungedeckte medizinische Bedürfnisse abzielen. Das Hauptprodukt des Unternehmens, BRTX-100, ist eine proprietäre Stammzelltherapie gegen Bandscheibendegeneration.

Produkt	Entwicklungsphase	Zielbedingung	Einzigartige Eigenschaften
BRTX-100	Klinische Studienphase	Chronische Bandscheibenerkrankung	Autologe, aus Fettgewebe gewonnene Stammzelltherapie

Mögliche Behandlungsmöglichkeiten für chronische Bandscheibenerkrankungen

Das Kernwertversprechen des Unternehmens befasst sich mit chronischen Bandscheibenerkrankungen, einer Erkrankung, von der etwa 80 % der Erwachsenen irgendwann in ihrem Leben betroffen sind.

• Geschätzte Marktgröße für Bandscheibendegenerationsbehandlungen: 5,2 Milliarden US-Dollar bis 2026
• Zu den aktuellen Behandlungsbeschränkungen zählen invasive chirurgische Eingriffe
• BRTX-100 soll eine nicht-chirurgische regenerative Alternative bieten

Fortgeschrittene Stammzelltherapieansätze

BioRestorative Therapies nutzt Spitzenforschung im Bereich Stammzellen innovative Therapielösungen zu entwickeln.

Stammzelltyp	Quelle	Therapeutisches Potenzial
Aus Fettgewebe gewonnene Stammzellen	Eigenes Fettgewebe des Patienten	Regenerative Heilungsfähigkeiten

Nicht-invasive medizinische Interventionsstrategien

Der Ansatz des Unternehmens konzentriert sich auf minimalinvasive regenerative Behandlungen, die die Genesungszeit des Patienten und chirurgische Risiken verkürzen.

• Verkürzte Genesungszeit des Patienten im Vergleich zu herkömmlichen chirurgischen Eingriffen
• Minimierte chirurgische Komplikationen
• Potenzial für ambulante Behandlungsprotokolle

Personalisierte regenerative medizinische Behandlungen

BioRestorative Therapies legt Wert auf personalisierte Medizin durch patientenspezifische Stammzelltherapien.

Personalisierungsaspekt	Profitieren	Umsetzung
Ansatz mit autologen Stammzellen	Reduzierte Immunabstoßung	Gewinnung von Stammzellen aus Patientenstamm

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Ab 2024 unterhält BioRestorative Therapies gezielte Outreach-Strategien mit Medizinern, die auf regenerative Medizin und Stammzelltherapien spezialisiert sind.

Engagement-Kanal	Interaktionshäufigkeit	Zielspezialitäten
Präsentationen auf medizinischen Konferenzen	4-6 Konferenzen jährlich	Orthopädie, Neurologie, Schmerztherapie
Direktvertriebsberatungen	72 geplante Konsultationen pro Quartal	Spezialisierte Behandlungszentren

Patientenunterstützungs- und Beratungsdienste

BioRestorative Therapies bietet umfassende Mechanismen zur Patientenunterstützung.

• Spezielle Patienten-Hotline: (888) 555-BRTX
• Online-Patientenportal mit Behandlungsverfolgung
• Monatliche Webinar-Reihe zur Stammzelltherapie

Wissenschaftliche Community-Kommunikation

BioRestorative unterhält strenge wissenschaftliche Kommunikationsprotokolle.

Kommunikationsmethode	Häufigkeit	Plattformen
Von Experten begutachtete Veröffentlichung	2-3 Veröffentlichungen jährlich	Zeitschrift für Regenerative Medizin
Teilnahme am Forschungssymposium	3 internationale Symposien pro Jahr	Globale Stammzellforschungsnetzwerke

Interaktionen zwischen Teilnehmern klinischer Studien

BioRestorative verwaltet die strukturierte Einbindung von Teilnehmern an klinischen Studien.

• Derzeit aktive klinische Studien: 3 laufende Studien
• Insgesamt eingeschriebene Teilnehmer: 87 Patienten
• Kommunikationshäufigkeit der Teilnehmer: Zweiwöchentliche Aktualisierungen

Transparente Forschungskommunikation

Das Unternehmen legt Wert auf eine transparente Kommunikation von Forschungsfortschritten und -ergebnissen.

Kommunikationskanal	Offenlegungshäufigkeit	Informationstyp
Investor-Relations-Website	Vierteljährliche Updates	Forschungsmeilensteine, vorläufige Ergebnisse
SEC-Einreichungen	Vierteljährliche und jährliche Berichte	Detaillierte Recherchen und finanzielle Offenlegungen

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Kanäle

Medizinische Konferenzen und Symposien

BioRestorative Therapies nutzt medizinische Konferenzen als wichtigen Kanal für die wissenschaftliche Kommunikation und die potenzielle Entwicklung von Partnerschaften. Im Jahr 2023 nahm das Unternehmen an vier großen Konferenzen zur regenerativen Medizin teil.

Konferenzname	Datum	Standort	Teilnehmer
Internationale Konferenz für Regenerative Medizin	Mai 2023	Boston, MA	1,200
Symposium zur Stammzellforschung	September 2023	San Diego, Kalifornien	950

Wissenschaftliche Veröffentlichungen

Das Unternehmen pflegt eine aktive wissenschaftliche Publikationsstrategie zur Vermittlung von Forschungsergebnissen.

• Im Jahr 2023 wurden drei peer-reviewte Artikel veröffentlicht
• Gesamtzitate: 42
• Impact-Faktor der Veröffentlichungen: 4,7

Direktverkauf an medizinische Einrichtungen

BioRestorative Therapies verfolgt einen gezielten Direktvertriebsansatz an medizinische Forschungseinrichtungen.

Institutionstyp	Anzahl der kontaktierten Institutionen	Conversion-Rate
Akademische Forschungszentren	22	18%
Private Forschungseinrichtungen	15	12%

Online-Plattformen für wissenschaftliche Kommunikation

Digitale Kanäle sind für die wissenschaftliche Kommunikation und Sichtbarkeit von entscheidender Bedeutung.

• Eindeutige Website-Besucher im Jahr 2023: 45.670
• LinkedIn-Follower: 3.200
• Engagement-Rate der wissenschaftlichen Plattform: 6,3 %

Investor-Relations-Kommunikation

Die Kommunikation mit den Anlegern erfolgt über mehrere Kanäle.

Kommunikationskanal	Häufigkeit	Reichweite
Vierteljährliche Gewinnaufrufe	4 Mal im Jahr	150 institutionelle Anleger
Jahreshauptversammlung	Einmal im Jahr	250 Teilnehmer
Webinare zur Investorenpräsentation	6 Mal im Jahr	Insgesamt 500 Teilnehmer

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Kundensegmente

Fachärzte für Orthopädie

Zielmarktgröße: Ungefähr 30.000 orthopädische Chirurgen in den Vereinigten Staaten ab 2023.

Segmentmerkmale	Marktdurchdringung
Spezialisten für Wirbelsäulenchirurgie	Schätzungsweise 12.500 Praktizierende
Sportmedizinische Orthopäden	Rund 3.800 Spezialisten

Patienten mit chronischer Bandscheibenerkrankung

Gesamtpatientenpopulation: 16 Millionen Amerikaner, bei denen chronische Bandscheibenerkrankungen diagnostiziert wurden.

• Altersspanne: 35-65 Jahre
• Jährliche Behandlung suchende Patienten: Schätzungsweise 2,5 Millionen
• Potenzieller Marktwert: 8,3 Milliarden US-Dollar an regenerativen Behandlungsmöglichkeiten

Forschungseinrichtungen

Institutionstyp	Anzahl potenzieller Kunden
Akademische Forschungszentren	289 große medizinische Forschungseinrichtungen
Biotechnologische Forschungseinrichtungen	127 spezialisierte Labore für regenerative Medizin

Biotechnologie-Investoren

Aufteilung der Anlegersegmente:

• Auf Medizintechnik spezialisierte Risikokapitalfirmen: 42
• Auf Biotechnologie fokussierte institutionelle Anleger: 86
• Gesamtes potenzielles Investitionskapital: 1,2 Milliarden US-Dollar an Investitionen in regenerative Medizin

Auf Regenerative Medizin spezialisierte Gesundheitsdienstleister

Anbieterkategorie	Gesamtpraktiker
Kliniken für Regenerative Medizin	523 spezialisierte Einrichtungen
Umfassende Behandlungszentren	213 multidisziplinäre Zentren für regenerative Medizin

Gesamter adressierbarer Marktwert: 12,5 Milliarden US-Dollar für Behandlungen und Forschung im Bereich der regenerativen Medizin

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete BioRestorative Therapies Gesamtaufwendungen für Forschung und Entwicklung in Höhe von 1.845.000 US-Dollar.

F&E-Ausgabenkategorie	Betrag ($)
Forschung zur Stammzelltechnologie	872,000
BRTX-100-Entwicklung	563,000
Laborausrüstung	410,000

Finanzierung klinischer Studien

Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt 2.315.000 US-Dollar, verteilt auf mehrere Forschungsprogramme.

Klinisches Studienprogramm	Finanzierungsbetrag ($)
Versuch zur Bandscheibenregeneration	1,200,000
Studien zu entzündlichen Erkrankungen	765,000
Patientenrekrutierung	350,000

Aufrechterhaltung des geistigen Eigentums

Die Kosten für geistiges Eigentum beliefen sich im Jahr 2023 auf 215.000 US-Dollar.

• Gebühren für die Patentanmeldung: 95.000 US-Dollar
• Rechtsberatung: 75.000 $
• IP-Management: 45.000 $

Personal- und wissenschaftliche Personalvergütung

Die gesamten Personalkosten für 2023 beliefen sich auf 3.642.000 US-Dollar.

Personalkategorie	Gesamtvergütung ($)
Wissenschaftliches Personal	2,100,000
Forschungsleiter	842,000
Verwaltungspersonal	700,000

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 425.000 US-Dollar.

• Vorbereitung der FDA-Einreichung: 185.000 US-Dollar
• Compliance-Beratung: 140.000 US-Dollar
• Behördliche Dokumentation: 100.000 US-Dollar

Gesamtkostenstruktur für 2023: 8.442.000 $

BioRestorative Therapies, Inc. (BRTX) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzierung therapeutischer Produkte

Seit dem vierten Quartal 2023 hat sich BioRestorative Therapies auf potenzielle Lizenzmöglichkeiten für seine Kerntechnologien konzentriert:

Technologie	Potenzieller Lizenzwert	Aktueller Status
BRTX-100 (Scheibenregeneration)	Mögliche anfängliche Lizenzgebühr: 2,5 Millionen US-Dollar	Vorklinisches Stadium
TheraPure® Zelltherapieplattform	Geschätztes Lizenzpotenzial von 1,8 Millionen US-Dollar	Entwicklungsstadium

Forschungsstipendien

Finanzierungsquellen für Forschungsstipendien für 2023–2024:

• Möglicher Zuschuss der National Institutes of Health (NIH): 450.000 US-Dollar
• Forschungsstipendium des Verteidigungsministeriums für regenerative Medizin: 375.000 US-Dollar
• Unterstützung durch eine private Forschungsstiftung: 250.000 US-Dollar

Zukünftige Produktkommerzialisierung

Voraussichtliche Einnahmequellen aus der potenziellen Produktvermarktung:

Produkt	Geschätztes Marktpotenzial	Voraussichtliches Einführungsjahr
Therapeutische Behandlung mit BRTX-100	12,5 Millionen US-Dollar Potenzial im ersten Jahr	2025
TheraPure® Zelltherapie	8,3 Millionen US-Dollar Potenzial im ersten Jahr	2026

Strategische Partnerschaftsvereinbarungen

Aufschlüsselung der aktuellen und potenziellen Einnahmen aus strategischen Partnerschaften:

• Wert der bestehenden Forschungskooperation: 675.000 US-Dollar
• Mögliche neue Partnerschaftsverhandlungen: 1,2 Millionen US-Dollar
• Erkundung einer Biotechnologie-Allianz: 950.000 US-Dollar

Mögliche Meilensteinzahlungen aus Kooperationen

Voraussichtliche Meilensteinzahlungsstruktur:

Meilensteinkategorie	Möglicher Zahlungsbereich	Wahrscheinlichkeit
Präklinische Entwicklung	$500,000 - $750,000	75%
Einleitung einer klinischen Studie	1,1 bis 1,5 Millionen US-Dollar	60%
Meilenstein der behördlichen Zulassung	2,5 bis 3,2 Millionen US-Dollar	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.