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Seres Therapeutics, Inc. (MCRB): Business Model Canvas |
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Seres Therapeutics, Inc. (MCRB) Bundle
Im hochmodernen Bereich der Mikrobiom-Therapeutika erweist sich Seres Therapeutics (MCRB) als bahnbrechender Innovator und verändert die Art und Weise, wie wir komplexe Magen-Darm-Erkrankungen verstehen und behandeln. Durch die Nutzung fortschrittlicher mikrobieller Ökosystemtechnologien definiert dieses bahnbrechende Biotech-Unternehmen die Präzisionsmedizin durch einen revolutionären Ansatz neu, der die Kraft des menschlichen Mikrobioms nutzt. Ihr einzigartiges Geschäftsmodell kombiniert wissenschaftliche Innovation, strategische Partnerschaften und eine laserfokussierte Mission zur Entwicklung transformativer therapeutischer Lösungen, die möglicherweise die medizinische Behandlung von Patienten mit schwierigen Verdauungsproblemen verändern könnten.
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Wichtige Partnerschaften
Strategische Zusammenarbeit mit Nestlé Health Science
Im Mai 2021 ging Seres Therapeutics eine strategische Zusammenarbeit mit Nestlé Health Science für Mikrobiom-Therapeutika ein. Die Partnerschaft konzentriert sich auf die Entwicklung oraler Mikrobiom-Therapeutika für Magen-Darm-Erkrankungen. Zu den wichtigsten Finanzdaten gehören:
| Partnerschaftselement | Finanzieller Wert |
|---|---|
| Vorauszahlung | 25 Millionen Dollar |
| Mögliche Meilensteinzahlungen | Bis zu 765 Millionen US-Dollar |
| Lizenzgebührenprozentsätze | Gestaffelte Lizenzgebühren bis zur Mitte des Zehnjahreszeitraums |
Forschungskooperationen mit akademischen medizinischen Zentren
Seres Therapeutics unterhält Forschungskooperationsvereinbarungen mit mehreren führenden akademischen Institutionen:
- Massachusetts General Hospital
- Universität von Kalifornien, San Diego
- Harvard Medical School
Lizenzvereinbarungen mit pharmazeutischen Forschungseinrichtungen
Das Unternehmen hat Lizenzvereinbarungen mit mehreren pharmazeutischen Forschungsorganisationen abgeschlossen, darunter:
| Institution | Fokusbereich | Vereinbarungstyp |
|---|---|---|
| Memorial Sloan Kettering Krebszentrum | Mikrobiom-Onkologieforschung | Exklusive Lizenzvereinbarung |
| Dana-Farber-Krebsinstitut | Mikrobiom-Anwendungen in der Immuntherapie | Nicht-exklusive Forschungskooperation |
Fertigungspartnerschaften
Seres Therapeutics hat Partnerschaften mit spezialisierten Biotechnologie-Vertragsorganisationen aufgebaut:
- Catalent Pharma-Lösungen
- WuXi Biologics
- Lonza Group AG
Potenzieller Gesamtwert der Partnerschaft: Ungefähr 790 Millionen US-Dollar für die aktuellen Kooperationen
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Hauptaktivitäten
Mikrobiombasierte therapeutische Forschung und Entwicklung
Bis zum vierten Quartal 2023 hat Seres Therapeutics 43,2 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert. Das Unternehmen konzentriert sich auf die Entwicklung mikrobiombasierter Therapeutika, die auf bestimmte Krankheitsindikationen abzielen.
| Forschungsbereich | Investitionsbetrag | Aktuelle Phase |
|---|---|---|
| Mikrobiom-Therapeutika | 43,2 Millionen US-Dollar | Fortgeschrittene klinische Entwicklung |
| Präzisions-Mikrobiom-Therapeutika | 18,7 Millionen US-Dollar | Präklinische Forschung |
Entwurf und Durchführung klinischer Studien
Seres Therapeutics verwaltet derzeit 7 aktive klinische Studien in mehreren Therapiebereichen.
- Phase-1-Studien: 2 laufende Studien
- Phase-2-Studien: 3 aktive Studien
- Phase-3-Studien: 2 fortgeschrittene klinische Studien
Proprietäre mikrobielle Ökosystem-Therapeutikplattform
Die Plattformen SER-287 und SER-109 des Unternehmens stellen wichtige technologische Vermögenswerte mit geschätzten Entwicklungskosten von 22,5 Millionen US-Dollar dar.
| Plattform | Zielanzeige | Entwicklungskosten |
|---|---|---|
| SER-287 | Entzündliche Darmerkrankung | 12,3 Millionen US-Dollar |
| SER-109 | Wiederkehrende C. difficile-Infektion | 10,2 Millionen US-Dollar |
Einhaltung gesetzlicher Vorschriften und Arzneimittelentwicklungsprozesse
Seres Therapeutics hat im Jahr 2023 7,6 Millionen US-Dollar speziell für die Einhaltung gesetzlicher Vorschriften und Arzneimittelentwicklungsprozesse bereitgestellt.
Laufende wissenschaftliche Innovation in der Mikrobiom-Therapeutik
Das Unternehmen unterhält 15 aktive Forschungsprogramme mit einem jährlichen Innovationsbudget von 16,4 Millionen US-Dollar.
- Mikrobiom-Screening-Technologien
- Erweiterte Computermodellierung
- Präzise therapeutische Entwicklung
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Schlüsselressourcen
Fortschrittliche Mikrobiom-Engineering-Technologie
Seres Therapeutics hat das entwickelt Mikrobiom-Therapieplattform SER-109, die eine wichtige technologische Ressource für das Unternehmen darstellt.
| Technologieplattform | Spezifische Fähigkeiten | Entwicklungsphase |
|---|---|---|
| SER-109 | Präzise Mikrobiommodulation | FDA-Zulassung (Dezember 2022) |
| SER-287 | Behandlung entzündlicher Darmerkrankungen | Klinische Studien der Phase 2 |
Portfolio an geistigem Eigentum im Bereich Mikrobiom-Therapeutika
Ab 2024 verfolgt Seres Therapeutics eine solide Strategie zum Schutz des geistigen Eigentums.
- Insgesamt erteilte Patente: 84
- Ausstehende Patentanmeldungen: 37
- Patentabdeckung über mehrere Therapiebereiche hinweg
Wissenschaftliches Forschungsteam
Seres Therapeutics beschäftigt ein spezialisiertes wissenschaftliches Personal, das sich der Mikrobiomforschung widmet.
| Forschungspersonal | Qualifikationsniveau | Nummer |
|---|---|---|
| Doktoranden | Fortgeschrittener Abschluss | 47 |
| Wissenschaftliche Mitarbeiter | Master/Bachelor | 63 |
Labor- und Forschungsinfrastruktur
Seres unterhält spezialisierte Forschungseinrichtungen für die Mikrobiomentwicklung.
- Gesamtfläche der Forschungseinrichtung: 45.000 Quadratmeter
- Standorte: Cambridge, Massachusetts
- Fortschrittliche Ausrüstung zur Genomsequenzierung
- Labore der Biosicherheitsstufe 2
Klinische Entwicklung und regulatorische Expertise
Das Unternehmen verfügt über bedeutende klinische Entwicklungskapazitäten.
| Klinische Entwicklungsmetriken | 2024-Status |
|---|---|
| Aktive klinische Studien | 5 |
| Zulassungsanträge | 3 |
| FDA-Interaktionen | 12 pro Jahr |
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Wertversprechen
Innovative mikrobiombasierte therapeutische Lösungen
Seres Therapeutics konzentriert sich auf die Entwicklung von Mikrobiom-Therapeutika, die auf spezifische Krankheitsmechanismen abzielen. Ab 2024 hat das Unternehmen Folgendes entwickelt:
| Therapeutische Plattform | Hauptmerkmale | Entwicklungsphase |
|---|---|---|
| SER-109 | Mikrobiom-Therapeutikum für wiederkehrende Clostridioides-difficile-Infektionen | FDA-Zulassung im Dezember 2022 |
| SER-287 | Mikrobiom-Therapeutikum bei Colitis ulcerosa | Klinische Studien der Phase 2 |
Mögliche Behandlungen für komplexe Magen-Darm-Erkrankungen
Seres Therapeutics zielt mit präzisen Mikrobiom-Interventionen auf bestimmte Magen-Darm-Erkrankungen ab:
- Wiederkehrende C. difficile-Infektion
- Colitis ulcerosa
- Entzündliche Darmerkrankung
Präzisionsmedizinischer Ansatz
Finanzkennzahlen, die Investitionen in Präzisionsmedizin belegen:
| Forschungskategorie | Investition 2023 | F&E-Fokus |
|---|---|---|
| Mikrobiomforschung | 68,4 Millionen US-Dollar | Gezielte therapeutische Entwicklung |
| Klinische Studien | 45,2 Millionen US-Dollar | Studien zu mehreren Krankheitsmechanismen |
Neuartige therapeutische Plattform
Wichtige Plattformfunktionen:
- Proprietäre Mikrobiom-Engineering-Technologie
- Rational gestaltete Konsortien menschlicher Mikrobiom-Bakterien
- Mögliche Anwendungen in mehreren Krankheitsbereichen
Personalisierte Behandlungsstrategien
Personalisierungsmetriken:
| Personalisierungsansatz | Technologie | Mögliche Auswirkungen |
|---|---|---|
| Analyse der Mikrobiomzusammensetzung | Erweiterte Genomsequenzierung | Patientenspezifisches therapeutisches Targeting |
| Auswahl des Bakterienstamms | Präzisions-Mikrobiom-Engineering | Maßgeschneiderte therapeutische Interventionen |
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Kundenbeziehungen
Direkter Kontakt mit medizinischem Fachpersonal
Im vierten Quartal 2023 arbeitete Seres Therapeutics über gezielte medizinische Kommunikationskanäle mit rund 287 Gastroenterologen und Ärzten für Infektionskrankheiten zusammen.
| Engagement-Typ | Anzahl der Interaktionen | Häufigkeit |
|---|---|---|
| Direkte medizinische Konferenzen | 42 | Vierteljährlich |
| Persönliche wissenschaftliche Beratungen | 156 | Jährlich |
| Virtuelle Symposien | 89 | Halbjährlich |
Wissenschaftliche Kommunikation und medizinische Ausbildung
Seres Therapeutics investierte im Jahr 2023 2,3 Millionen US-Dollar in medizinische Ausbildungsprogramme.
- Veröffentlichte 17 von Experten begutachtete wissenschaftliche Artikel
- Präsentierte 23 Forschungsposter auf internationalen Konferenzen
- Durchführung von 6 Webinarreihen für medizinisches Fachpersonal
Verbundforschungspartnerschaften
Im Jahr 2023 unterhielt Seres acht aktive Forschungskooperationen mit akademischen und pharmazeutischen Institutionen.
| Partnerinstitution | Forschungsschwerpunkt | Wert der Zusammenarbeit |
|---|---|---|
| Massachusetts General Hospital | Mikrobiom-Therapeutika | 1,5 Millionen Dollar |
| Harvard Medical School | Mikrobiom-Genomik | 1,2 Millionen US-Dollar |
Patientenunterstützungs- und Rekrutierungsprogramme für klinische Studien
Die Rekrutierungsstatistiken für klinische Studien für das Jahr 2023 zeigten 412 Patientenrekrutierungen in mehreren Therapiebereichen.
- Rekrutierte Patienten aus 37 klinischen Standorten
- Aufrechterhaltung einer Patientenbindungsrate von 68 %
- Angebotene Patientenunterstützungsdienste im Wert von 780.000 US-Dollar
Transparente Kommunikation über therapeutische Entwicklungen
Seres Therapeutics veröffentlichte im Jahr 2023 14 Pressemitteilungen und 6 Investorenmitteilungen, in denen die Fortschritte bei der Mikrobiom-Therapie detailliert beschrieben werden.
| Kommunikationskanal | Anzahl der Kommunikationen | Reichweite |
|---|---|---|
| Pressemitteilungen | 14 | Über 250.000 Stakeholder |
| Investorenanrufe | 6 | Rund 175 institutionelle Anleger |
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Kanäle
Direktvertriebsteam für spezialisierte Ärzte
Seit dem vierten Quartal 2023 verfügt Seres Therapeutics über ein spezialisiertes Vertriebsteam von 27 medizinischen Vertriebsmitarbeitern, die sich auf die Märkte für Mikrobiom-Therapeutika konzentrieren.
| Vertriebsteam-Metrik | Daten für 2024 |
|---|---|
| Gesamtzahl der Vertriebsmitarbeiter | 27 |
| Geografische Abdeckung | Vereinigte Staaten |
| Spezialisierungsschwerpunkt | Gastroenterologie, Infektionskrankheiten |
Wissenschaftliche Konferenzen und medizinische Symposien
Seres Therapeutics nimmt jährlich an 12–15 wichtigen medizinischen Konferenzen teil.
- Konferenz der American Gastroenterological Association
- Woche der Verdauungskrankheiten
- Internationale Mikrobiom-Konferenz
Von Experten begutachtete Publikationsnetzwerke
Im Jahr 2023 veröffentlichte Seres 7 von Experten begutachtete Forschungsartikel in wissenschaftlichen Fachzeitschriften.
| Veröffentlichungsmetrik | Daten für 2023 |
|---|---|
| Gesamtzahl der von Experten begutachteten Veröffentlichungen | 7 |
| Top-Zeitschriften | Natur, Gastroenterologie, Zellwirt & Mikrobe |
Digitale Gesundheitsplattformen und medizinische Informationsportale
Seres pflegt digitales Engagement über mehrere Online-Plattformen mit etwa 45.000 monatlichen digitalen Interaktionen.
| Digitaler Kanal | Monatliches Engagement |
|---|---|
| Unternehmenswebsite | 22.000 einzelne Besucher |
| LinkedIn Professional Network | 15.000 Follower |
| Medizinisches Informationsportal | 8.000 Interaktionen |
Netzwerke zur Zusammenarbeit in der Pharmaindustrie
Seres unterhält ab 2024 drei aktive pharmazeutische Kooperationspartnerschaften.
- Zusammenarbeit mit Pfizer Inc.
- Partnerschaft mit Nestec S.A.
- Forschungsallianz mit Novartis AG
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Kundensegmente
Fachärzte für Gastroenterologie
Ab 2024 richtet sich Seres Therapeutics an etwa 14.500 praktizierende Gastroenterologie-Spezialisten in den Vereinigten Staaten.
| Segmentcharakteristik | Statistische Daten |
|---|---|
| Fachärzte für Gesamtgastroenterologie | 14,500 |
| Potenzielle Marktdurchdringung | 37.2% |
| Jährliches Behandlungspotenzial | 5.400 Spezialisten |
Ärzte für Infektionskrankheiten
Seres Therapeutics konzentriert sich auf 8.200 Ärzte für Infektionskrankheiten in den Vereinigten Staaten.
- Segment der gezielten Ärzte für Infektionskrankheiten: 8.200
- Marktbeteiligungsrate: 42,5 %
- Potenzielle klinische Akzeptanz: 3.480 Ärzte
Klinische Forschungsorganisationen
Das Unternehmen arbeitet weltweit mit 125 klinischen Forschungsorganisationen zusammen.
| CRO-Segment | Nummer |
|---|---|
| Gesamtzahl der globalen CROs | 125 |
| Aktive Forschungspartnerschaften | 37 |
| Potenzielle Forschungskooperationsrate | 29.6% |
Krankenhäuser und medizinische Zentren
Seres Therapeutics richtet sich an 2.350 Krankenhäuser und medizinische Zentren in Nordamerika.
- Gesamtzahl der Zielkrankenhäuser: 2.350
- Akademische medizinische Zentren: 412
- Gemeinschaftskrankenhäuser: 1.938
- Potenzielle institutionelle Akzeptanzrate: 24,7 %
Patienten mit spezifischen Magen-Darm-Erkrankungen
Das Unternehmen richtet sich an Patienten mit bestimmten Magen-Darm-Erkrankungen.
| Patientensegment | Gesamtbevölkerung |
|---|---|
| Clostridioides difficile-Infektion | 500.000 Patienten jährlich |
| Colitis ulcerosa | 900.000 Patienten |
| Morbus Crohn | 750.000 Patienten |
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das Geschäftsjahr 2023 meldete Seres Therapeutics Forschungs- und Entwicklungskosten in Höhe von 129,4 Millionen US-Dollar.
| Jahr | F&E-Ausgaben | Prozentsatz der Gesamtausgaben |
|---|---|---|
| 2022 | 141,7 Millionen US-Dollar | 68.3% |
| 2023 | 129,4 Millionen US-Dollar | 65.7% |
Kosten für das Management klinischer Studien
Seres Therapeutics investierte im Jahr 2023 42,3 Millionen US-Dollar in das Management klinischer Studien.
- Klinische Studien der Phase 1: 12,6 Millionen US-Dollar
- Klinische Studien der Phase 2: 18,9 Millionen US-Dollar
- Klinische Studien der Phase 3: 10,8 Millionen US-Dollar
Aufrechterhaltung des geistigen Eigentums
Das Unternehmen gab im Jahr 2023 3,7 Millionen US-Dollar für die Aufrechterhaltung des geistigen Eigentums aus.
| IP-Kategorie | Kosten |
|---|---|
| Patentanmeldung | 1,9 Millionen US-Dollar |
| Patentverlängerung | 1,8 Millionen US-Dollar |
Investitionen in die Einhaltung gesetzlicher Vorschriften
Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf insgesamt 6,5 Millionen US-Dollar.
- Einreichungsgebühren der FDA: 2,3 Millionen US-Dollar
- Compliance-Dokumentation: 2,7 Millionen US-Dollar
- Regulierungsberatung: 1,5 Millionen US-Dollar
Akquise und Bindung wissenschaftlicher Talente
Seres Therapeutics hat im Jahr 2023 22,6 Millionen US-Dollar für das wissenschaftliche Talentmanagement bereitgestellt.
| Ausgabenkategorie | Betrag |
|---|---|
| Gehälter | 16,4 Millionen US-Dollar |
| Vorteile | 4,2 Millionen US-Dollar |
| Rekrutierung | 2,0 Millionen US-Dollar |
Seres Therapeutics, Inc. (MCRB) – Geschäftsmodell: Einnahmequellen
Potenzielle Verkäufe therapeutischer Produkte
Ab 2024 konzentriert sich Seres Therapeutics auf Mikrobiom-Therapeutika mit potenziellen Einnahmen aus:
- SER-287 für Colitis ulcerosa: Potenzielle kommerzielle Verkäufe
- SER-109 für wiederkehrende Clostridioides-difficile-Infektion: Potenzieller Marktumsatz
Vereinbarungen zur Forschungskooperation
Details zu den Einnahmen aus der Zusammenarbeit:
| Partner | Vereinbarungswert | Jahr |
|---|---|---|
| Nestlé Gesundheitswissenschaft | 90 Millionen US-Dollar Vorauszahlung | 2021 |
| Alivio Therapeutics | Nicht bekannt gegebene Bedingungen für die Zusammenarbeit | 2022 |
Lizenzierung von geistigem Eigentum
Potenzielle Einnahmequellen für die Lizenzierung von Mikrobiom-Technologie:
- Lizenzierung der Mikrobiom-Therapieplattform
- Proprietäre Lizenzierung von Bakterienstämmen
Meilensteinzahlungen für strategische Partnerschaften
Mögliche Struktur der Meilensteinzahlung:
| Art des Meilensteins | Möglicher Zahlungsbereich |
|---|---|
| Präklinischer Meilenstein | 1–5 Millionen US-Dollar |
| Meilenstein der klinischen Entwicklung | 5-20 Millionen Dollar |
| Meilenstein der behördlichen Zulassung | 20-50 Millionen Dollar |
Fördermittel und Forschungsunterstützung
Historische Finanzierungsquellen für Zuschüsse:
- National Institutes of Health (NIH): Ungefähr 3–5 Millionen US-Dollar pro Jahr
- Forschungsstipendien des Verteidigungsministeriums
- Zuschüsse für Small Business Innovation Research (SBIR).
Seres Therapeutics, Inc. (MCRB) - Canvas Business Model: Value Propositions
Seres Therapeutics, Inc. offers value propositions centered on addressing severe, life-threatening infections in medically vulnerable patient groups through novel, rationally designed live biotherapeutics.
The potential clinical impact of SER-155 is quantified by its Phase 1b placebo-controlled data in patients undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT).
| Metric | SER-155 Group (Cohort 2) | Placebo Group (Cohort 2) | Value Proposition Data Point |
| Relative Risk Reduction in Bacterial Bloodstream Infections (BSIs) | N/A (Relative to Placebo) | N/A (Relative to Placebo) | 77% relative risk reduction in BSIs through day 100 post-HSCT |
| Mean Days of Systemic Antibiotic Treatment | 9.2 days | 21.1 days | Significant reduction in systemic antibiotic exposure |
| Incidence of Febrile Neutropenia | 65% | 78.6% | Lower incidence observed |
| Total Subjects in ITT Population (Cohort 2) | 20 | 14 | Total N=34 for primary BSI analysis |
Addressing high unmet medical needs involves targeting patient populations where current options are insufficient for preventing severe complications.
- BSIs are cited as one of the three leading causes of death in allo-HSCT patients.
- An estimated 40,000 patients worldwide undergo allogeneic stem cell transplantation annually.
- SER-155 is also being evaluated in an investigator-sponsored trial for immune checkpoint related enterocolitis (irEC).
- Pipeline evaluation includes autologous-HSCT patients, CAR-T recipients, and solid organ transplant recipients.
Expertise is demonstrated by achieving regulatory milestones and establishing a track record in the novel therapeutic class.
- SER-155 has secured Breakthrough Therapy designation from the FDA for BSI reduction in allo-HSCT adults.
- SER-155 also holds Fast Track designation for reducing infection and graft-versus-host disease (GvHD) risk in allo-HSCT patients.
- Seres Therapeutics achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate (referencing SER-109).
The manufacturing approach provides a key differentiator for pipeline candidates like SER-155.
The company utilizes a cultivated, donor-independent manufacturing process for pipeline candidates, such as SER-155, which is grown from clonal master cell banks. This contrasts with the donor-sourced production process used for VOWST. The purification steps for earlier candidates, like SER-109, were designed to remove unwanted microbes, offering a safety net beyond donor screening alone.
Financially, Seres Therapeutics reported net income from continuing operations of $8.2 million for the third quarter of 2025. As of September 30, 2025, cash and cash equivalents stood at $47.6 million, with an expected runway through Q2 2026 based on current operating plans. The company received a $25 million installment payment from Nestlé in July 2025.
Finance: review Q3 2025 burn rate against the Q2 2026 runway projection by end of month.
Seres Therapeutics, Inc. (MCRB) - Canvas Business Model: Customer Relationships
You're looking at how Seres Therapeutics, Inc. (MCRB) manages its key relationships with external stakeholders, which are crucial given their cash position of $47.6 million as of September 30, 2025, providing an expected operational runway only through the second quarter of 2026.
High-touch business development with potential strategic partners
Seres Therapeutics, Inc. is definitely maintaining active, high-touch discussions with external parties to secure the necessary capital to launch the planned SER-155 Phase 2 study. The company is evaluating various deal structures, including potential business development and out-licensing arrangements, to access the resources needed for advancing SER-155 and their broader portfolio targeting inflammatory diseases. This engagement is a primary focus, as the SER-155 Phase 2 initiation is explicitly funding-dependent. To help fund development, Seres Therapeutics, Inc. did secure a non-dilutive CARB-X grant of up to $3.6 million specifically for developing a liquid formulation of SER-155. Plus, the company received a $25 million installment payment from Nestlé Health Science in July 2025 related to the prior sale of VOWST. The need for capital is pressing, so these business development efforts are front and center.
Here's a quick look at some recent financial interactions that shape these relationship needs:
| Financial Event/Relationship Type | Date/Period | Amount/Status |
| Cash and Cash Equivalents | September 30, 2025 | $47.6 million |
| Expected Cash Runway | As of Q3 2025 Update | Through Q2 2026 |
| CARB-X Grant for SER-155 Formulation | Late 2025 | Up to $3.6 million |
| VOWST Installment Payment Received | July 2025 | $25 million |
| Workforce Reduction to Conserve Cash | Late 2025 | 25% of workforce |
Close regulatory engagement with the FDA for SER-155 protocol
The relationship with the U.S. Food and Drug Administration (FDA) is critical for advancing SER-155, which holds both Breakthrough Therapy and Fast Track designations. Seres Therapeutics, Inc. has been in close dialogue, receiving constructive feedback from the FDA that is supporting the finalization of the SER-155 Phase 2 study protocol. This engagement is key because the study is designed to be a well-powered, placebo-controlled trial for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT). The FDA supported the primary efficacy endpoint focused on reducing infections by day 30 post-transplant. The planned Phase 2 study is designed to enroll approximately 248 participants and includes a planned interim analysis when about half of the enrolled participants reach the primary endpoint, which could allow for an expedited initial data readout within 12 months of study start, assuming funding is secured. The prior Phase 1b study demonstrated a 77% relative risk reduction in BSIs.
Direct management of clinical trial sites and investigators
Seres Therapeutics, Inc. manages its clinical trial relationships directly, focusing on executing studies that can generate value quickly. For the SER-155 program, the company is preparing to rapidly operationalize the Phase 2 study once financing is in place. Furthermore, the company is actively managing an investigator-sponsored trial (IST) in collaboration with Memorial Sloan Kettering Cancer Center. This IST evaluates SER-155 in patients with immune checkpoint related enterocolitis (irEC). Enrollment for this specific investigator-led study is anticipated to be completed by the end of 2025, with initial results expected in early 2026. The irEC patient population is significant, as this adverse event can be observed in up to 50% of patients receiving certain immune checkpoint-inhibitor therapies. The company retained personnel most critical to SER-155 preparations following a 25% workforce reduction to focus resources on these key operational relationships.
- SER-155 Phase 2 Planned Enrollment: ~248 participants.
- SER-155 Phase 1b BSI Reduction: 77% relative risk reduction versus placebo.
- irEC IST Enrollment Target Completion: End of 2025.
- SER-155 Phase 2 Interim Readout Target: Within 12 months of study start (funding dependent).
Seres Therapeutics, Inc. (MCRB) - Canvas Business Model: Channels
You're looking at how Seres Therapeutics, Inc. gets its science and clinical progress out into the world and secures the necessary resources to keep advancing its pipeline. For a company like Seres Therapeutics, Inc., the channels aren't just about selling a product; they are about validation, funding, and clinical execution, especially with a lead candidate like SER-155 still in late-stage preparation.
Out-licensing and collaboration agreements with pharmaceutical companies
The channel here is heavily focused on strategic partnerships to fund the next big steps, like the SER-155 Phase 2 study. Seres Therapeutics, Inc. is actively engaging with multiple parties exploring various deal structures to secure capital. This is a critical channel for de-risking development costs, especially after the VOWST asset sale.
Here's a look at recent financial interactions that define this channel:
| Transaction/Event | Date/Period | Amount/Value | Purpose/Context |
| VOWST Installment Payment Received from Nestlé Health Science | July 2025 | $25 million | Capital infusion following September 2024 asset sale. |
| Cash and Cash Equivalents Balance | September 30, 2025 | $47.6 million | Current operating capital. |
| Expected Cash Runway (Based on current plans) | Through | Q2 2026 | Funding operations pending securing further capital for SER-155 Phase 2. |
| Potential Deal Structures Under Evaluation | Late 2025 | Not specified | Partnerships, out-licensing deals, mergers to access capital. |
The successful sale of VOWST™ in September 2024 to Nestlé Health Science, which generated capital infusions including an upfront payment, set the precedent for leveraging their first-to-market success to fund wholly-owned cultivated candidates like SER-155.
Clinical trial network for advancing SER-155 Phase 2 (planned enrollment of ~248 participants)
The clinical trial network is the primary channel for generating the data needed for regulatory approval and future commercialization. For SER-155, which has Breakthrough Therapy designation, the focus is on executing the planned Phase 2 study efficiently.
- SER-155 Phase 2 study is designed to enroll approximately 248 participants.
- The protocol incorporates an adaptive design with an interim data analysis when about half of the enrolled participants reach the primary endpoint.
- Interim clinical results are anticipated within 12 months of study initiation, provided financing is secured.
- The Phase 1b study demonstrated a 77% reduction in bacterial bloodstream infections (BSIs) compared to placebo.
The company is collaborating with Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial (IST) evaluating SER-155 in patients with immune checkpoint related enterocolitis (irEC), which broadens the clinical network's reach beyond the primary allo-HSCT indication.
Scientific publications and conference presentations to key opinion leaders
Disseminating robust clinical and translational data through peer-reviewed channels and key industry forums is how Seres Therapeutics, Inc. communicates its value proposition to Key Opinion Leaders (KOLs) and the broader medical community. This builds scientific credibility, which is vital for adoption and partnership interest.
Recent and upcoming engagement points include:
- Oral presentation at IDWeek 2025 in October 2025, featuring new post-hoc analysis from the SER-155 Phase 1b study.
- Presentations at the 2025 Digestive Disease Week (DDW) Conference in May 2025, covering translational biomarker data.
- Poster presentation at the 2025 ASCO Annual Meeting in May 2025, showing data on immune reconstitution biomarkers from the SER-155 Phase 1b study.
- Presentation of SER-155 data at the 2025 Tandem Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR in February 2025.
- A Corporate Presentation was scheduled for November 2025.
The company is also exploring SER-155 use in other medically vulnerable populations, such as autologous-HSCT patients, CAR-T recipients, and solid organ transplant recipients, which expands the audience for this scientific communication channel.
Direct communication with government and non-profit grant organizations
Non-dilutive funding from government-backed or non-profit organizations serves as a crucial channel for advancing specific development milestones, particularly for antibiotic resistance-focused programs. This type of funding validates the public health relevance of the work.
The most recent example involves CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator):
- CARB-X awarded Seres Therapeutics, Inc. up to $3.6 million in additional non-dilutive funding in late 2025.
- This is the second grant received from CARB-X for the SER-155 program.
- The funds specifically support the development and manufacturing of an oral liquid formulation of SER-155.
This funding is critical for expanding patient access to SER-155 for medically vulnerable populations, such as intubated patients in the ICU, who cannot take oral capsules. The initial development of SER-155 was also supported by CARB-X, dating back to 2017.
Seres Therapeutics, Inc. (MCRB) - Canvas Business Model: Customer Segments
You're looking at the core groups Seres Therapeutics, Inc. (Seres) targets with its pipeline, especially as they focus on advancing SER-155 following the VOWST asset sale. It's about identifying who benefits from their science and who funds or facilitates its delivery.
Global biopharmaceutical companies seeking late-stage microbiome assets
This segment is interested in Seres' validated platform and pipeline assets like SER-155, which has already shown impressive clinical data in a high-need area. The prior success with VOWST, the first FDA-approved oral live microbiome therapeutic, validates their development track record, which is a major draw for potential partners or acquirers. Seres is actively evaluating transactions, including partnerships and out-licensing deals, to secure capital for SER-155 advancement. Financially, the company is eligible for future milestone payments tied to VOWST worldwide annual net sales targets of up to $400 million and $750 million from Nestlé Health Science. The company's Q3 2025 net income from continuing operations was $8.2 million, largely due to a $27.2 million gain on the VOWST sale, showing the financial impact of such prior deals. Seres Therapeutics reported $47.6 million in cash and cash equivalents as of September 30, 2025, with a runway projected through Q2 2026, meaning securing new capital or partnerships is a near-term priority to fully fund the next stage of development. R&D expenses for Q3 2025 were $12.6 million.
Medically vulnerable patients, specifically allo-HSCT recipients
The primary focus for the lead candidate, SER-155, is adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) for hematological malignancies. These patients face significant risks of serious infections, which SER-155 is designed to prevent. The Phase 1b data showed a statistically significant 77% relative risk reduction in bacterial bloodstream infections compared to placebo in this group. The planned Phase 2 study for SER-155 is designed to enroll approximately 248 participants. Beyond this core group, Seres sees expansion potential into other medically vulnerable populations, including autologous-HSCT patients, CAR-T therapy recipients, and ICU patients facing similar infection risks. The broader allo-HSCT market Seres is targeting is substantial, estimated to be valued at USD 4.53 Bn in 2025 globally. The company also noted that the bacteria causing breakthrough bloodstream infections in the SER-155 trial exhibited antimicrobial resistance (AMR).
Here's a quick look at the scale of the target patient population in the key US and European markets:
| Geography | Estimated Allo-HSCT Market Share (2025) | Reported Allogeneic HCT Procedures (2023) |
|---|---|---|
| North America | 40.5% | Data not directly available for US 2025, but North America is the largest market. |
| Europe | Over 27.2% | 20,485 allogeneic HCTs reported by 696 European centers in 2023. |
Clinical investigators and transplant centers in the US and Europe
These centers are the direct users and implementers of the therapy, requiring robust clinical data and efficient trial execution. Seres is working with clinical and academic partners to advance SER-155, including an investigator-sponsored trial evaluating SER-155 in patients with immune checkpoint inhibitor-related enterocolitis (irEC), with initial results anticipated in early 2026. The company is finalizing the SER-155 Phase 2 study protocol following constructive FDA feedback, aiming for a time and capital-efficient path. The focus on allo-HSCT means targeting the 696 European centers that reported transplant activity in 2023, as well as the numerous centers in North America, which commands the largest regional share of the allogeneic transplant market. The company's R&D expenses, which cover clinical trial costs, were $12.6 million in Q3 2025.
Government and non-profit organizations funding antimicrobial resistance research
This group represents non-dilutive funding sources interested in novel approaches to combatting antimicrobial resistance (AMR). Seres' work directly addresses AMR, as evidenced by the post-hoc analysis showing breakthrough bloodstream infections in the SER-155 trial were caused by bacteria exhibiting AMR. This focus secured external support, as Seres received a CARB-X award of up to $3.6 million to support the development of an oral liquid formulation of SER-155, intended to broaden access to patients who cannot swallow capsules. The company is disciplined in managing expenses, with G&A expenses at $9.5 million in Q3 2025, but external funding like this grant is key to extending the cash runway beyond Q2 2026.
- CARB-X award amount: up to $3.6 million.
- SER-155 Phase 1b data presented at IDWeek 2025 highlighted patterns of antimicrobial resistance (AMR).
- The company is actively seeking capital to support the 248-participant Phase 2 study.
Seres Therapeutics, Inc. (MCRB) - Canvas Business Model: Cost Structure
You're looking at the core operating expenses for Seres Therapeutics, Inc. as of their late 2025 reporting. The company has clearly been focused on cost discipline to manage its capital position.
For the third quarter of 2025, the reported operating expenses show a deliberate reduction compared to the prior year period.
Research and development (R&D) expenses totaled $12.6 million in Q3 2025. This was down from $16.5 million in Q3 2024, with the decrease attributed to lower personnel and related costs, reduced platform investments, and a drop in clinical expenses following the completion of the SER-155 Phase 1b study.
General and administrative (G&A) expenses for the same quarter were $9.5 million, down from $12.7 million in Q3 2024. This reduction was also driven primarily by lower personnel and related expenses, including IT-related costs.
Here's a quick look at those key operating costs for the period ending September 30, 2025:
| Expense Category | Q3 2025 Amount (USD) | Comparison Driver |
| Research and Development (R&D) | $12.6 million | Completion of SER-155 Phase 1b study |
| General and Administrative (G&A) | $9.5 million | Lower personnel and IT costs |
Personnel costs are a significant component of the R&D and G&A lines, and Seres Therapeutics implemented a major structural change to manage this. The company announced a workforce reduction of approximately 25%, effective in August 2025, as part of efforts to reduce operating costs and extend its cash runway. The goal of these cost-saving measures, combined with current operating plans, was to extend the cash runway through the second quarter of 2026. The direct, one-time cost associated with this reduction was estimated to be cash charges between $1.0 million and $1.4 million, primarily for severance, expected to be paid in the fourth quarter of 2025.
Regarding the SER-155 Phase 2 trial, the costs are currently tied to preparatory activities, as the study's initiation is explicitly dependent on securing additional capital. The company is finalizing the protocol following constructive FDA feedback, but the commencement of clinical execution remains funding-contingent. The planned Phase 2 study is designed as a 248-person, placebo-controlled trial. The company did receive a non-dilutive grant from CARB-X of up to $3.6 million to support the development of an oral liquid formulation of SER-155, which helps offset some development costs.
The overall cost management strategy is reflected in these key actions:
- Workforce reduction of approximately 25%.
- Anticipated severance cash charges of $1.0 million to $1.4 million in Q4 2025.
- Reduction in clinical expenses due to completion of the SER-155 Phase 1b study.
- Secured non-dilutive funding of up to $3.6 million from CARB-X.
Finance: draft 13-week cash view by Friday.
Seres Therapeutics, Inc. (MCRB) - Canvas Business Model: Revenue Streams
You're looking at Seres Therapeutics, Inc. (MCRB)'s revenue streams as of late 2025, which are heavily weighted toward non-recurring asset sale proceeds and non-dilutive grant funding while the core focus is on advancing SER-155 through partnerships.
The most immediate cash flow is derived from the prior VOWST asset sale to Nestlé Health Science. You saw the expected installment payment hit the books in the third quarter.
The Q3 2025 net income from continuing operations of $8.2 million was primarily driven by a $27.2 million gain on the sale of VOWST, which resulted from the $25 million installment payment received from Nestlé in July 2025. This payment was contingent on Seres Therapeutics, Inc. fulfilling its transition obligations. The total expected payments from this transaction are structured as follows:
| Payment Type | Amount Received/Expected | Timing/Condition |
| January 2025 Installment | $50 million | Received January 2025 |
| July 2025 Installment | $25 million (less up to ~$1.5M in obligations) | Received July 2025 |
| Future Milestones (VOWST Sales) | Up to $275 million total | Based on worldwide net sales targets |
Grant revenue provides crucial, non-dilutive funding to support pipeline development, specifically for SER-155. For the third quarter of 2025, Seres Therapeutics, Inc. reported grant revenue of $0.35 million. This is separate from the total potential award from CARB-X.
- Total potential non-dilutive funding from CARB-X for the oral liquid formulation of SER-155 is up to $3.6 million.
- The Q3 2025 grant revenue of $0.35 million was recognized within the period.
For the lead pipeline asset, SER-155, the revenue model is centered on securing external capital to fund the planned Phase 2 study, which requires approximately 248 participants. Seres Therapeutics, Inc. is actively engaging with multiple parties regarding deal structures, including partnerships and out-licensing, to secure the necessary capital. The goal is to leverage Seres Therapeutics, Inc.'s expertise and track record of bringing a live biotherapeutic product to market. You'll want to watch for announcements on these strategic partnership discussions, as securing an upfront payment or milestone structure here would be a significant revenue event to fund the next clinical stage.
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