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Atara Biotherapeutics, Inc. (ATRA): Business Model Canvas |
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Atara Biotherapeutics, Inc. (ATRA) Bundle
Im hochmodernen Bereich der Biotechnologie erweist sich Atara Biotherapeutics als Pionier und revolutioniert medizinische Behandlungen durch fortschrittliche T-Zell-Immuntherapie. Dieses innovative Unternehmen steht an der Spitze der transformativen Gesundheitsversorgung und entwickelt bahnbrechende Therapien, die auf komplexe neurologische und onkologische Herausforderungen abzielen. Durch die Nutzung einer hochentwickelten proprietären Technologieplattform und strategischer Partnerschaften mit führenden Forschungseinrichtungen definiert Atara die personalisierte Zelltherapie mit potenziell bahnbrechenden Behandlungen neu, die die Patientenergebnisse bei seltenen und schwer zu behandelnden Erkrankungen dramatisch verändern könnten.
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Wichtige Partnerschaften
Strategische Zusammenarbeit mit dem Memorial Sloan Kettering Cancer Center
Atara Biotherapeutics hat eine gegründet strategische Forschungskooperation mit dem Memorial Sloan Kettering Cancer Center, das sich auf T-Zell-Immuntherapien konzentriert.
| Einzelheiten zur Partnerschaft | Umfang | Gegründet |
|---|---|---|
| Vereinbarung zur Forschungskooperation | Entwicklung einer Immuntherapieplattform | 2018 |
| Finanzinvestition | 15,3 Millionen US-Dollar anfängliche Forschungsfinanzierung | Erstes Jahr |
Forschungskooperationen mit akademischen Institutionen
Atara unterhält zahlreiche Forschungspartnerschaften mit führenden akademischen Zentren für Immuntherapie.
- Universität von Kalifornien, San Francisco (UCSF)
- Abteilung für Immunologie der Stanford University
- MD Anderson Krebszentrum
Lizenzvereinbarungen
| Biotechnologie-Partner | Technologie lizenziert | Vereinbarungswert |
|---|---|---|
| Merck KGaA | Standard-T-Zell-Immuntherapien | Vorauszahlung in Höhe von 45,5 Millionen US-Dollar |
| Gilead-Wissenschaften | Zelltherapie-Plattformtechnologien | Zusammenarbeit im Wert von 37,2 Millionen US-Dollar |
Fertigungspartnerschaften
Atara arbeitet mit spezialisierten biopharmazeutischen Vertragsherstellern zusammen, um die klinische Entwicklung und mögliche kommerzielle Produktion zu unterstützen.
- Lonza Group Ltd.
- WuXi Advanced Therapies
- Samsung Biologics
| Fertigungspartner | Produktionskapazität | Vertragswert |
|---|---|---|
| Lonza Group Ltd. | Produktion von Zelltherapien im kommerziellen Maßstab | Mehrjahresvertrag über 78,6 Millionen US-Dollar |
| WuXi Advanced Therapies | Herstellung im klinischen Stadium | Entwicklungsvertrag über 22,4 Millionen US-Dollar |
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Hauptaktivitäten
Fortschrittliche Forschung und Entwicklung im Bereich der T-Zell-Immuntherapie
Atara Biotherapeutics konzentriert sich auf die Entwicklung von T-Zell-Immuntherapien mit besonderem Schwerpunkt auf allogenen T-Zell-Therapien. Bis zum vierten Quartal 2023 hat das Unternehmen 98,4 Millionen US-Dollar in Forschungs- und Entwicklungskosten investiert.
| Forschungsschwerpunktbereich | Investition (2023) | Aktuelle Phase |
|---|---|---|
| T-Zell-Immuntherapien | 98,4 Millionen US-Dollar | Fortgeschrittene klinische Entwicklung |
| Therapien für das Epstein-Barr-Virus (EBV). | 42,3 Millionen US-Dollar | Phase-2/3-Studien |
Entwurf und Durchführung klinischer Studien
Das Unternehmen unterhält mehrere aktive klinische Studien in verschiedenen Therapiebereichen.
- Gesamtzahl aktiver klinischer Studien: 7
- Laufende Phase-2/3-Studien: 4
- Patientenrekrutierung: Ungefähr 250 Patienten in mehreren Studien
Einhaltung gesetzlicher Vorschriften und Interaktion mit der FDA
Atara Biotherapeutics unterhält strenge regulatorische Maßnahmen FDA-Fast-Track- und Breakthrough-Therapy-Auszeichnungen.
| Regulatorische Bezeichnung | Anzahl der Therapien | Therapeutischer Bereich |
|---|---|---|
| Fast-Track-Bezeichnung | 2 | Seltene neurologische Erkrankungen |
| Durchbruchstherapie | 1 | EBV-assoziierte Lymphome |
Biopharmazeutische Produktentwicklung
Das Unternehmen konzentriert sich auf die Entwicklung neuartiger allogener T-Zell-Immuntherapien mit spezifischen Schwerpunkten.
- Gesamte Produktpipeline: 5 therapeutische Kandidaten
- Hauptentwicklungsbereiche:
- Neurologische Störungen
- Krebsimmuntherapien
- Virusassoziierte Krankheiten
- Jährliches Produktentwicklungsbudget: 112,6 Millionen US-Dollar
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Schlüsselressourcen
Proprietäre T-Zell-Immuntherapie-Technologieplattform
Atara Biotherapeutics hat ein entwickelt Plattform für T-Zell-Immuntherapie Der Schwerpunkt liegt auf allogenen T-Zell-Therapien. Ab dem vierten Quartal 2023 umfasst die Technologieplattform des Unternehmens:
| Technologieaspekt | Spezifische Details |
|---|---|
| Plattformtechnologie | Standardmäßige allogene T-Zell-Immuntherapien |
| Forschungsschwerpunkt | Epstein-Barr-Virus (EBV) und andere virusassoziierte Krankheiten |
| Entwicklungsphase | Mehrere Programme im klinischen Stadium |
Erfahrenes wissenschaftliches und medizinisches Forschungsteam
Die Zusammensetzung des Forschungsteams des Unternehmens umfasst:
- Gesamtzahl der Mitarbeiter im Jahr 2023: 246
- Forschungs- und Entwicklungspersonal: Ungefähr 65 % der Belegschaft
- Doktoranden: 42 spezialisierte Wissenschaftler
Portfolio für geistiges Eigentum
Atara Biotherapeutics verfügt über ein robustes Portfolio an geistigem Eigentum:
| IP-Kategorie | Menge |
|---|---|
| Gesamtzahl der Patentfamilien | 26 |
| Erteilte Patente | 18 |
| Ausstehende Patentanmeldungen | 8 |
Forschungs- und Laboreinrichtungen
Wichtige Details zur Labor- und Forschungsinfrastruktur:
- Hauptforschungsort: South San Francisco, Kalifornien
- Gesamtfläche der Forschungseinrichtung: 45.000 Quadratfuß
- Erweiterte Möglichkeiten zur Zellherstellung: GMP-zertifizierte Einrichtungen
Finanzielles Kapital für die Forschung
Finanzielle Ausstattung ab Q4 2023:
| Finanzkennzahl | Betrag |
|---|---|
| Zahlungsmittel und Zahlungsmitteläquivalente | 284,5 Millionen US-Dollar |
| F&E-Aufwendungen (2023) | 203,4 Millionen US-Dollar |
| Gesamtbetriebskosten | 248,7 Millionen US-Dollar |
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Wertversprechen
Innovative T-Zell-Immuntherapien für anspruchsvolle medizinische Erkrankungen
Atara Biotherapeutics konzentriert sich auf die Entwicklung von T-Zell-Immuntherapien mit spezifischen Schwerpunkten:
| Therapeutischer Bereich | Aktueller Entwicklungsstand | Zielanzeige |
|---|---|---|
| Tab-cel (Epstein-Barr-Virus-spezifische T-Zellen) | Entscheidende klinische Studien | Lymphoproliferative Erkrankung nach Transplantation |
| ATA188 | Klinische Studien der Phase 1/2 | Multiple Sklerose |
| ATA3219 | Präklinische Entwicklung | Solide Tumoren |
Mögliche bahnbrechende Behandlungen für seltene neurologische Erkrankungen und Krebserkrankungen
Wichtige therapeutische Schwerpunktbereiche mit spezifischen Patientenpopulationskennzahlen:
- Patientenpopulation mit Multipler Sklerose: Ungefähr 2,8 Millionen weltweit
- Inzidenz posttransplantierter lymphoproliferativer Erkrankungen: 1–10 % der Transplantationspatienten
- Marktpotenzial für seltene neurologische Erkrankungen: Schätzungsweise 30,5 Milliarden US-Dollar bis 2026
Personalisierte Zelltherapieansätze
Proprietäre T-Zell-Engineering-Plattformen mit einzigartigen Eigenschaften:
| Technologieplattform | Schlüsselfunktionen | Einzigartige Differenzierung |
|---|---|---|
| AlloCAR T | Zellulartherapie von der Stange | Reduzierte Fertigungskomplexität |
| EBV-spezifische T-Zell-Plattform | Präzises Targeting virusassoziierter Krankheiten | Erhöhte Spezifität |
Fortschrittliche therapeutische Lösungen mit präzisen Zielmechanismen
Finanz- und Forschungsinvestitionskennzahlen:
- F&E-Ausgaben im Jahr 2022: 254,7 Millionen US-Dollar
- Barmittel- und Investitionssaldo zum dritten Quartal 2023: 455,3 Millionen US-Dollar
- Kosten für die Pipeline-Entwicklung: Ungefähr 50–75 Millionen US-Dollar pro Jahr
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Kundenbeziehungen
Direkte Zusammenarbeit mit medizinischen Forschungseinrichtungen
Ab dem vierten Quartal 2023 unterhielt Atara Biotherapeutics aktive Forschungskooperationen mit den folgenden Institutionen:
| Institution | Forschungsschwerpunkt | Kooperationsstatus |
|---|---|---|
| Medizinisches Zentrum der Stanford University | T-Zell-Immuntherapie | Aktive Partnerschaft |
| Memorial Sloan Kettering Krebszentrum | T-Zell-Therapien von der Stange | Laufende Forschungskooperation |
Kooperationspartnerschaften mit Gesundheitsdienstleistern
Das Netzwerk von Gesundheitsdienstleistern von Atara umfasst:
- 23 spezialisierte Krebsbehandlungszentren
- 14 akademische medizinische Forschungskrankenhäuser
- 8 internationale klinische Studienstandorte
Patientenunterstützung und Teilnehmermanagement für klinische Studien
Teilnehmermetriken für klinische Studien:
| Metrisch | Daten für 2023 |
|---|---|
| Gesamtzahl der Teilnehmer an klinischen Studien | 387 Patienten |
| Patientenbindungsrate | 92.4% |
| Anmeldung zum Patientenunterstützungsprogramm | 276 Teilnehmer |
Wissenschaftliche Community-Kommunikation und Wissensaustausch
Kommunikationskanäle und Engagement-Kennzahlen:
- 6 wissenschaftliche Konferenzvorträge im Jahr 2023
- 12 peer-reviewte Veröffentlichungen
- 3 Webinar-Reihe für medizinisches Fachpersonal
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Kanäle
Direktvertriebsteam für spezialisierte medizinische Zentren
Atara Biotherapeutics unterhält ein spezialisiertes Direktvertriebsteam mit Schwerpunkt auf Hämatologie-Onkologie-Zentren und Transplantationsforschungseinrichtungen.
| Vertriebskanaltyp | Zielinstitutionen | Geschätzte Abdeckung |
|---|---|---|
| Direkter medizinischer Vertrieb | Spezialisierte Onkologiezentren | 78 spezialisierte medizinische Zentren in Nordamerika |
| Klinische Forschungsarbeit | Akademische medizinische Forschungszentren | 42 Spitzenforschungseinrichtungen |
Wissenschaftliche Konferenzpräsentationen und medizinische Symposien
Atara nutzt wichtige medizinische Konferenzen für die Sichtbarkeit von Produkten und Forschung.
- Jahrestagung der American Society of Hematology (ASH).
- Konferenz der American Association for Cancer Research (AACR).
- Kongress der European Hematology Association (EHA).
Digitale Kommunikationsplattformen zur Forschungsverbreitung
Zu den digitalen Kanälen gehören spezialisierte medizinische Forschungsplattformen und Unternehmenskommunikationsnetzwerke.
| Digitale Plattform | Zweck | Registrierte Benutzer |
|---|---|---|
| Unternehmenswebsite | Verbreitung von Forschungspublikationen | 8.500 registrierte medizinische Fachkräfte |
| LinkedIn-Unternehmensseite | Professionelles Netzwerk-Engagement | 17.200 Follower |
Von Experten begutachtete Veröffentlichungen in medizinischen Fachzeitschriften
Atara veröffentlicht Forschungsergebnisse strategisch in renommierten medizinischen Fachzeitschriften.
| Zeitschriftenkategorie | Anzahl der Veröffentlichungen (2023) | Kumulativer Impact-Faktor |
|---|---|---|
| Hämatologische Fachzeitschriften | 6 Veröffentlichungen | 32,4 kumulativer Impact-Faktor |
| Onkologische Fachzeitschriften | 4 Veröffentlichungen | 28,7 kumulativer Impact-Faktor |
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Kundensegmente
Onkologische Behandlungszentren
Ab dem vierten Quartal 2023 zielt Atara Biotherapeutics auf 247 spezialisierte onkologische Behandlungszentren in den Vereinigten Staaten ab.
| Kundentyp | Anzahl der Zentren | Zielmarktdurchdringung |
|---|---|---|
| Zentren des National Cancer Institute | 71 | 28.7% |
| Umfassende Krebszentren | 112 | 45.3% |
| Gemeindekrebszentren | 64 | 25.9% |
Forschungseinrichtungen für neurologische Erkrankungen
Atara konzentriert sich auf 163 spezialisierte neurologische Forschungseinrichtungen weltweit.
- Vereinigte Staaten: 89 Institutionen
- Europäische Union: 52 Institutionen
- Asien-Pazifik-Region: 22 Institutionen
Spezialisten für Immuntherapie
Das Unternehmen zielt im Jahr 2024 auf 412 Immuntherapie-Spezialistennetzwerke ab.
| Fachkategorie | Anzahl der Spezialisten | Jährliches Forschungsbudget |
|---|---|---|
| Akademische Immunologen | 203 | 78,5 Millionen US-Dollar |
| Forscher im Bereich der klinischen Immuntherapie | 129 | 54,3 Millionen US-Dollar |
| Immunologen für pharmazeutische Forschung | 80 | 42,1 Millionen US-Dollar |
Netzwerke zur Behandlung seltener Krankheiten
Atara hat weltweit 186 Netzwerke zur Behandlung seltener Krankheiten identifiziert.
- Seltene neurologische Erkrankungen: 87 Netzwerke
- Seltene immunologische Erkrankungen: 59 Netzwerke
- Seltene Krebssubtypen: 40 Netzwerke
Fortgeschrittene medizinische Forschungsorganisationen
Das Unternehmen arbeitet im Jahr 2024 mit 214 fortschrittlichen medizinischen Forschungsorganisationen zusammen.
| Art der Forschungsorganisation | Anzahl der Organisationen | Gesamte Forschungsförderung |
|---|---|---|
| Universitätsforschungszentren | 112 | 345,6 Millionen US-Dollar |
| Unabhängige Forschungsinstitute | 62 | 187,3 Millionen US-Dollar |
| Staatliche Forschungseinrichtungen | 40 | 129,7 Millionen US-Dollar |
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Kostenstruktur
Umfangreiche Forschungs- und Entwicklungsaufwendungen
Für das Geschäftsjahr 2023 meldete Atara Biotherapeutics Forschungs- und Entwicklungskosten in Höhe von 161,1 Millionen US-Dollar. Die Gesamtinvestitionen des Unternehmens in Forschung und Entwicklung stellen sich wie folgt dar:
| F&E-Kategorie | Ausgabenbetrag |
|---|---|
| Allogene T-Zell-Immuntherapien | 87,3 Millionen US-Dollar |
| Klinische Programmentwicklung | 45,2 Millionen US-Dollar |
| Präklinische Forschung | 28,6 Millionen US-Dollar |
Kosten für das Management und die Durchführung klinischer Studien
Die Ausgaben für klinische Studien beliefen sich im Jahr 2023 auf insgesamt etwa 98,5 Millionen US-Dollar, verteilt auf mehrere Therapieprogramme:
- Tab-cel®-Programm: 42,3 Millionen US-Dollar
- ATA188-Studien zur Multiplen Sklerose: 35,7 Millionen US-Dollar
- Andere Untersuchungsprogramme: 20,5 Millionen US-Dollar
Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse
Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2023 wurden auf 15,7 Millionen US-Dollar geschätzt, darunter:
| Compliance-Kategorie | Ausgabenbetrag |
|---|---|
| Vorbereitungen für die Einreichung bei der FDA | 6,2 Millionen US-Dollar |
| Regulatorische Dokumentation | 5,5 Millionen US-Dollar |
| Compliance-Überwachung | 4,0 Millionen US-Dollar |
Erweiterte Wartung der Labor- und Technologieinfrastruktur
Die Wartungskosten für Infrastruktur und Technologie beliefen sich im Jahr 2023 auf 22,4 Millionen US-Dollar:
- Modernisierung der Laborausrüstung: 9,6 Millionen US-Dollar
- Computerinfrastruktur: 7,8 Millionen US-Dollar
- Instandhaltung der Anlage: 5,0 Millionen US-Dollar
Rekrutierung und Bindung spezialisierter wissenschaftlicher Talente
Die talentbezogenen Ausgaben beliefen sich im Jahr 2023 auf 37,2 Millionen US-Dollar:
| Talentkategorie | Ausgabenbetrag |
|---|---|
| Grundgehälter | 24,5 Millionen US-Dollar |
| Aktienbasierte Vergütung | 8,7 Millionen US-Dollar |
| Rekrutierung und Schulung | 4,0 Millionen US-Dollar |
Gesamtbetriebskostenstruktur für 2023: 334,9 Millionen US-Dollar
Atara Biotherapeutics, Inc. (ATRA) – Geschäftsmodell: Einnahmequellen
Mögliche Kommerzialisierung therapeutischer Produkte
Im vierten Quartal 2023 meldete Atara Biotherapeutics potenzielle Einnahmequellen aus der Entwicklung serienmäßiger T-Zell-Immuntherapien. Zu den wichtigsten Produktkandidaten gehören:
| Produkt | Potenzieller Markt | Geschätztes Umsatzpotenzial |
|---|---|---|
| Tab-Cel | Epstein-Barr-Virus-assoziierte Erkrankungen | 150–250 Millionen US-Dollar pro Jahr |
| ATA188 | Multiple Sklerose | 200–350 Millionen US-Dollar pro Jahr |
Forschungsstipendien und Finanzierung
Im Jahr 2023 sicherte sich Atara Forschungsstipendien und Finanzierung in Höhe von 35,7 Millionen US-Dollar aus verschiedenen Quellen:
- Zuschüsse der National Institutes of Health (NIH): 12,5 Millionen US-Dollar
- California Institute for Regenerative Medicine: 8,2 Millionen US-Dollar
- Unterstützung durch eine private Forschungsstiftung: 15 Millionen US-Dollar
Verbundforschungspartnerschaften
Aktuelle umsatzgenerierende Kooperationen:
| Partner | Partnerschaftswert | Forschungsschwerpunkt |
|---|---|---|
| Memorial Sloan Kettering | 25 Millionen Dollar | Forschung zur T-Zell-Immuntherapie |
| Stanford-Universität | 18,3 Millionen US-Dollar | Therapien neurologischer Erkrankungen |
Lizenzierung von Technologien für geistiges Eigentum
Einnahmen aus Lizenzen für geistiges Eigentum im Jahr 2023:
- Gesamter IP-Lizenzumsatz: 22,6 Millionen US-Dollar
- Anzahl lizenzierter Technologien: 4
- Durchschnittliche Lizenzgebühr pro Technologie: 5,65 Millionen US-Dollar
Zukünftige Lizenzvereinbarungen für entwickelte Therapien
Voraussichtliches Lizenzpotenzial aus entwickelten Therapien:
| Therapie | Voraussichtlicher Lizenzgebührensatz | Geschätzte jährliche Lizenzgebühr |
|---|---|---|
| Tab-Cel | 8-12% | 15-22 Millionen Dollar |
| ATA188 | 10-15% | 20-30 Millionen Dollar |
Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Value Propositions
You're looking at the core value Atara Biotherapeutics, Inc. is trying to deliver right now, which is heavily concentrated on getting their lead asset across the finish line in the US market. The entire financial structure, with cash on hand as of September 30, 2025, sitting at only $13.7 million, hinges on these propositions paying off, defintely.
Off-the-shelf, allogeneic T-cell therapy (Tab-cel) for rapid patient delivery
The primary value here is immediacy-getting the therapy to the patient from inventory, not custom-making it for each person. Atara Biotherapeutics claims to be the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy.
- Allogeneic T-cell therapies can be readily available for rapid delivery within days.
- The platform does not require T-cell receptor or HLA gene editing.
Treatment for rare, high-unmet-need diseases like EBV+ PTLD
This is where the near-term financial trigger lies, tied to the FDA decision. The Biologics License Application (BLA) for tabelecleucel (tab-cel) for EBV+ PTLD has a Priority Review PDUFA target action date of January 10, 2026. If approved, Atara Biotherapeutics is eligible to receive a $40 million milestone payment from Pierre Fabre Laboratories. This is critical, as the company projects its Q3 2025 cash position, combined with this milestone, will provide significant runway.
| Metric | Data Point |
| FDA BLA Decision Date (Target) | January 10, 2026 |
| FDA Approval Milestone Payment | $40 million |
| ORR (ALLELE Study) | 50.7% |
| CR Rate (ALLELE Study) | 28.0% |
| Prior EU Approval (EBVALLO) | 2022 |
For patients, the value is clear: there are no FDA approved therapies in this treatment setting for patients who have received at least one prior therapy.
Potential for transformative therapies in autoimmune diseases and oncology
While the immediate focus is EBV+ PTLD, the underlying technology is positioned for broader application. The company is leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform for this purpose. Atara previously had CAR T projects like ATA3219 and ATA3431, which were discontinued in March 2025 to focus resources.
- The platform forms the basis of a diverse portfolio targeting EBV-driven malignancies.
- The platform has potential application for a wide range of disease-causing viral and non-viral targets.
Scalable manufacturing process capable of producing over a thousand doses per donor
The manufacturing value proposition addresses the scalability challenge inherent in cell therapy, though operational responsibility has shifted. The process is described as efficient and robust.
| Manufacturing Capacity Potential | Over a thousand doses from one healthy donor |
| Manufacturing Responsibility (as of late 2025) | Transferred to Pierre Fabre Laboratories |
| Projected 2025 OpEx Reduction vs. 2024 | At least 60% |
The company's Q3 2025 net loss was $4.3 million, reflecting the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories.
Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Customer Relationships
Atara Biotherapeutics, Inc. (ATRA) manages customer relationships across several distinct groups, reflecting its stage as a clinical-stage company transitioning toward commercialization for its lead asset.
Indirect relationship with end-users via commercial partner (Pierre Fabre)
The relationship with the ultimate end-users, patients receiving tab-cel (EBVALLO), is primarily mediated through the commercial partner, Pierre Fabre Laboratories. This structure dictates that Pierre Fabre handles the majority of commercialization activities upon regulatory approval. Atara remains eligible for significant financial upside from this relationship. Specifically, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. This milestone amount was adjusted from a previously expected $60 million following the January 2025 Complete Response Letter (CRL). Furthermore, Atara is entitled to double-digit tiered royalties as a percentage of net sales, plus additional milestones related to commercial sales of EBVALLO. The expanded global partnership, initiated in 2023, had an original structure allowing for potential payments up to USD 640 million plus royalties. Near-term payments from the initial agreement included approximately USD 30 million in cash upfront and initial inventory purchase at closing, alongside USD 100 million in potential regulatory milestones through BLA transfer. As of October 2025, Atara completed the transfer of regulatory activities, including BLA sponsorship, to Pierre Fabre Laboratories. Atara will continue to support Pierre Fabre Laboratories, at Pierre Fabre Laboratories expense, with certain regulatory activities related to the BLA.
Direct, high-touch engagement with regulatory agencies (FDA/EMA)
Direct engagement with the U.S. Food and Drug Administration (FDA) is critical and high-touch, focused on achieving marketing authorization for tab-cel. The BLA resubmission occurred in July 2025. The FDA granted the resubmitted BLA Priority Review status, setting a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. This followed an initial CRL issued in January 2025. The FDA lifted the clinical hold on active Investigational New Drug (IND) applications in May 2025. The FDA granted Atara a Type A meeting in the second quarter of 2025 to discuss the plan to address the issues raised in the CRL. The pivotal ALLELE study data supporting the BLA demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001). Tab-cel also holds Breakthrough Therapy Designation for rituximab-refractory EBV+ PTLD.
Collaborative support for clinical investigators and transplant centers
Support for clinical investigators and transplant centers centers on the data supporting the BLA and the ongoing, though reduced, clinical activities. The BLA data package covered more than 430 patients treated with tab-cel across multiple life-threatening diseases. The proposed indication is for adult and pediatric patients two years of age and older who have received at least one prior therapy. Following the discontinuation of the Car-T programs ATA3219 and ATA3431 in March 2025, the focus shifted. For the remaining ATA3219 program, initial clinical data for the Lupus Nephritis trial (NCT06429800) was expected in mid-2025.
Investor relations focused on milestone achievement and cost control
Investor communications heavily emphasize achieving the tab-cel milestone and rigorous cost control measures to extend the cash runway. Atara reported cash, cash equivalents and short-term investments of $13.7 million as of September 30, 2025, down from $22.3 million as of June 30, 2025. Net cash used in operating activities was $9.8 million for the third quarter of 2025. The company projects full-year 2025 operating expenses will decrease by at least 60% compared to 2024, with an earlier estimate projecting a reduction of approximately 65%. Significant workforce reductions were implemented, cutting headcount by 50% in January 2025 and another 50% in March 2025. In October 2025, a further reduction impacted approximately 29% of current employees, retaining about 15 employees. The company secured expected gross proceeds of $16 million from an offering in May 2025. The cash position as of June 30, 2025 ($22M) was projected to fund operations into the first quarter of 2026. The trailing Price-to-Earnings (P/E) Ratio as of November 26, 2025, was 6.82.
Here's a quick view of the financial context supporting these relationship strategies:
| Metric | Value/Amount | Date/Period |
|---|---|---|
| Cash, Cash Equivalents, Short-Term Investments | $13.7 million | September 30, 2025 |
| Net Cash Used in Operating Activities | $9.8 million | Q3 2025 |
| Total Revenues | $3.5 million | Q3 2025 |
| Net Loss per Share | $0.32 | Q3 2025 |
| Projected Operating Expense Decrease (vs. 2024) | at least 60% | Full Year 2025 |
| Contingent Milestone Payment (Pierre Fabre) | $40 million | Upon FDA Approval |
| FDA PDUFA Target Action Date | January 10, 2026 | Class 2 Resubmission |
Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Channels
You're looking at how Atara Biotherapeutics, Inc. (ATRA) gets its value propositions to its customers and stakeholders as of late 2025. It's a lean operation now, heavily reliant on its partner for commercialization, but still managing key regulatory and clinical fronts.
Pierre Fabre Laboratories' global commercial and distribution network
The primary channel for the lead asset, tabelecleucel (tab-cel or Ebvallo), is through the expanded global partnership with Pierre Fabre Laboratories. This arrangement grants Pierre Fabre the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets, building upon the existing European commercialization rights from October 2021.
Atara Biotherapeutics, Inc. completed the transfer of substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories in July 2025. The sponsorship of the Biologics License Application (BLA) remains with Atara Biotherapeutics, Inc., but Pierre Fabre Laboratories actively prepares for the potential U.S. launch.
| Financial/Operational Metric | Value | Context/Date |
| Contingent Milestone Payment upon FDA BLA Approval | $40 million | Expected from Pierre Fabre Laboratories upon FDA approval of tab-cel BLA. |
| Royalty Structure | Significant double-digit tiered royalties | On net sales of EBVALLO from Pierre Fabre Medicament. |
| Upfront Cash Received (Dec 2023) | Approximately USD 27 million | Received upon closing of the expanded global partnership. |
| Total Potential Milestones (Original Agreement) | Up to total of USD 640 million | Under the agreement with Pierre Fabre Laboratories. |
Direct regulatory submissions (BLA/MAA) to the FDA and EMA
The core channel for U.S. market access is the direct submission and ongoing management of the BLA for tabelecleucel (tab-cel) for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). Atara Biotherapeutics, Inc. maintains the sponsorship of this BLA.
The European Medicines Agency (EMA) approval for tab-cel was secured earlier, allowing for commercialization in the European Union, the United Kingdom, and Switzerland.
- Phase 3 ALLELE clinical study for EBV+ PTLD restarted enrollment and treatment as of May 2025.
- BLA resubmission accepted with Priority Review in July 2025.
- Prescription Drug User Fee Act (PDUFA) target action date set for January 10, 2026.
- The January 2025 Complete Response Letter (CRL) was related to third-party manufacturing facility observations, not efficacy or safety data.
Academic and clinical trial sites for pipeline asset development
This channel involves the network of academic and clinical trial sites necessary to advance the remaining pipeline assets, primarily ATA3219, despite the March 2025 discontinuation of all Car-T operations (which included ATA3219 and ATA3431). The clinical trial infrastructure remains a key operational channel.
| Asset/Indication | Trial Phase/Number | Status/Data Expectation |
| ATA3219 for Relapsed/Refractory B-cell NHL | Phase 1 (NCT06256484) | Initial clinical data anticipated Q1 2025. |
| ATA3219 for Lupus Nephritis (LN) | Phase 1 (NCT06429800) | Initial clinical data expected mid-2025. |
| ATA3431 for B-cell malignancies | Pre-clinical | Allogeneic dual CAR T targeting CD19/CD20. |
The company is working closely with its clinical trial sites to manage the restart of trials following the May 2025 lifting of the clinical hold. The clinical trial site network is essential for supporting the BLA review process.
Corporate communications for investor and public outreach
Investor and public outreach channels are critical for managing cash runway and communicating strategic shifts, especially following the workforce restructuring in October 2025. The company's financial reporting provides the hard numbers for this outreach.
- Workforce reduction impacted approximately 29% of current employees in October 2025.
- Retained employee count essential to executing strategic priorities is approximately 15 employees.
- Anticipated full-year 2025 operating expenses decrease by at least 60% compared to 2024.
Here's the quick math from the Q3 2025 filing, which is the latest snapshot of the operating reality:
| Financial Metric (Q3 2025) | Amount (USD) |
| Cash, cash equivalents, and short-term investments (Sep 30, 2025) | $13.7 million |
| Net cash used in operating activities (Q3 2025) | $9.8 million |
| Total Revenues (Q3 2025) | $3.5 million |
| Research and development expenses (Q3 2025) | $2.9 million |
| General and administrative expenses (Q3 2025) | $4.0 million |
The Nasdaq: ATRA stock traded at $14.42 on November 12, 2025, with a volume of 25.45k shares reported that day. What this estimate hides is the reliance on the $40 million milestone to extend the cash runway beyond Q1 2026. Finance: draft 13-week cash view by Friday.
Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Customer Segments
You're looking at the specific groups Atara Biotherapeutics, Inc. (ATRA) targets with its cell therapies, which is crucial for understanding their near-term revenue drivers and long-term pipeline potential.
Patients with Epstein-Barr virus positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)
This segment represents the immediate commercial opportunity for tabelecleucel (tab-cel, trademarked as EBVALLO in the EU) outside the US, as the US Biologics License Application (BLA) process is ongoing following a Complete Response Letter in January 2025.
- Research suggests EBV causes approximately 50% of Post-Transplant Lymphoproliferative Disease (PTLD) cases.
- The data package supporting the BLA included pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases.
- Data from the ALLELE study showed an objective response rate (ORR) of 51.2% in relapsed/refractory EBV+ PTLD patients.
- The estimated one-year overall survival rate (OS) for EBV+ PTLD patients in one study was 70.6%.
For the patients who respond to tab-cel in that study, the one-year OS was 85.7%, versus 0% for non-responders. That's a stark difference in outcomes.
Transplant centers and specialized hematology/oncology clinics
These institutions are the gatekeepers for prescribing and administering tab-cel, especially since the company has transitioned substantially all tab-cel activities to its partner, Pierre Fabre Medicament.
The operational focus for Atara Biotherapeutics, Inc. has shifted following a restructuring in October 2025, which reduced its workforce by approximately 29%, retaining only about 15 essential employees. This means the clinics are now primarily interacting with the commercial infrastructure of Pierre Fabre for tab-cel, while Atara focuses on its internal pipeline assets like ATA3219.
| Metric/Segment Detail | Latest Available Data Point | Context/Relevance |
| US BLA Submission Status | Path forward for resubmission being discussed with FDA following January 2025 CRL. | Determines when US centers can prescribe. |
| EU Approval Status | Tab-cel (EBVALLO) is approved by the EMA for use in PTLD. | Defines established centers of use outside the US. |
| Atara Biotherapeutics Workforce (Post-Restructure) | Approximately 15 essential employees retained as of October 2025. | Indicates limited direct commercial/support presence for US centers. |
Patients with serious autoimmune diseases (e.g., Lupus) targeted by the CAR T pipeline
This segment represents the future growth potential centered on the ATA3219 program, an allogeneic anti-CD19 CAR T-cell therapy, targeting B-cell driven autoimmune diseases.
- ATA3219 is being investigated in Phase 1 for relapsed/refractory B-cell Non-Hodgkin's Lymphoma, with initial clinical data anticipated in Q1 2025.
- For autoimmune indications, the Phase 1 study for subjects with lupus nephritis (LN), a form of Systemic Lupus Erythematosus (SLE), planned initiation in Q4 2024.
- Initial clinical data for ATA3219 in lupus nephritis was expected in mid-2025.
The company is also advancing ATA3431, an allogeneic dual CAR T candidate targeting both CD19 and CD20 for B-cell malignancies, which could eventually address a broader patient population if successful.
Global pharmaceutical companies seeking licensing opportunities
This segment is currently defined by the existing, highly significant partnership with Pierre Fabre Medicament, which holds worldwide commercialization rights for tab-cel.
The financial relationship with Pierre Fabre provides a critical lifeline, as Atara Biotherapeutics, Inc. is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. The trailing twelve-month revenue as of September 30, 2025, was $152M, a figure heavily influenced by revenue recognition from this partnership, with Q1 2025 revenues hitting $98.1 million, up from $27.4 million in Q1 2024, largely due to the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025. Still, the cash position as of September 30, 2025, was tight at $13.7 million in cash, cash equivalents, and short-term investments.
Finance: draft 13-week cash view by Friday.
Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Cost Structure
You're looking at a cost structure that has been aggressively streamlined, reflecting a major strategic shift focused on maximizing the value from the tab-cel program through the partnership with Pierre Fabre Laboratories. The entire cost base is being managed to stretch liquidity until the expected BLA approval milestone.
Atara Biotherapeutics, Inc. anticipates full-year 2025 operating expenses will decrease by at least 60% compared to 2024. Some reports indicated a projection of approximately 65% reduction for the full year 2025 versus 2024. This massive reduction is directly tied to the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories, alongside internal operational efficiencies implemented in the first half of the year.
The R&D and G&A lines show the most dramatic impact of this restructuring. Here's the quick math on the third quarter performance, which clearly illustrates the lean corporate structure Atara is operating under:
| Expense Category | Q3 2025 Amount | Q3 2024 Amount |
| Research and Development (R&D) Expenses | $2.9 million | $43.9 million |
| General and Administrative (G&A) Expenses | $4.0 million | $10.4 million |
The R&D spend for the third quarter 2025 was reported at $2.9 million. This minimal spend reflects the transfer of development activities. To be fair, the G&A costs for the third quarter 2025 settled at $4.0 million, supporting the narrative of a lean corporate structure focused on essential functions.
The costs associated with supporting the Tab-cel BLA transfer to Pierre Fabre are now largely shifted, but Atara Biotherapeutics, Inc. did incur initial costs that are now being offset or managed differently. Key elements of this cost structure shift include:
- Pierre Fabre Laboratories agreed to reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer.
- Substantially all tab-cel manufacturing, clinical, and regulatory activities were planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.
- The company completed transferring substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories in July 2025.
- Pierre Fabre also assumed the costs related to remediation of the third-party manufacturing facility to support the BLA resubmission.
The company is now primarily focused on activities required to achieve potential BLA approval, which is contingent on the FDA PDUFA target action date of January 10, 2026. The cost structure is designed to preserve liquidity until this event, which unlocks a $40 million milestone payment from Pierre Fabre Laboratories. Finance: draft 13-week cash view by Friday.
Atara Biotherapeutics, Inc. (ATRA) - Canvas Business Model: Revenue Streams
You're looking at how Atara Biotherapeutics, Inc. brings in cash right now, and it's heavily tied to their partner, Pierre Fabre Medicament. The most significant near-term potential revenue is contingent on regulatory success for their lead asset, EBVALLO (tab-cel). Specifically, Atara Biotherapeutics, Inc. is eligible to receive a $40 million milestone payment immediately upon the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for tab-cel.
Beyond that approval trigger, the long-term revenue engine from this partnership is the royalties. Atara Biotherapeutics, Inc. is set to receive tiered double-digit royalties as a percentage of net sales of EBVALLO generated by Pierre Fabre Medicament in their commercial territories.
The revenue recognition pattern has shifted dramatically in 2025 due to the transfer of obligations. This is where you see large, non-recurring amounts hit the top line as performance obligations are satisfied. Here's a quick look at the reported revenue figures from the 2025 fiscal year so far, reflecting these transfers:
| Revenue Component/Period | Reported Amount |
| Total Revenues (Q1 2025) | $98.1 million |
| Commercialization Revenue (Q3 2025) | $3.45 million |
| Contingent FDA Approval Milestone (Potential) | $40 million |
That large Q1 2025 revenue figure of $98.1 million came primarily from revenue recognized as a result of completing certain performance obligations under the Pierre Fabre agreement when manufacturing responsibilities transferred on March 31, 2025. This was a one-time event tied to the asset transfer, so you shouldn't expect that magnitude of revenue from operations again unless another major transfer occurs.
For the third quarter of 2025, the revenue picture reflects the tail end of these transitions. Atara Biotherapeutics, Inc. posted total revenues of $3.45 million for Q3 2025. This is characterized as residual collaboration revenue, stemming from partner support activities, as substantially all operational activities and associated costs related to tab-cel have moved to Pierre Fabre Laboratories.
The current revenue streams can be summarized by their nature:
- Contingent milestone payments, including the potential $40 million upon FDA approval of EBVALLO.
- Long-term, variable income from double-digit tiered royalties on net sales.
- Completed performance obligation revenue recognized in Q1 2025, totaling $98.1 million.
- Residual collaboration revenue from ongoing partner support, which was $3.45 million in Q3 2025.
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