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Altimmune, Inc. (ALT): Business Model Canvas |
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Altimmune, Inc. (ALT) Bundle
Altimmune, Inc. (ALT) entwickelt sich zu einem bahnbrechenden Biotechnologieunternehmen, das die Impfstoffentwicklung und Immuntherapie durch seinen innovativen Ansatz zur Bewältigung ungelöster medizinischer Herausforderungen revolutioniert. Durch die Nutzung fortschrittlicher Forschungskapazitäten und strategischer Partnerschaften leistet Altimmune Pionierarbeit bei intranasalen Impfstofftechnologien, die möglicherweise die Art und Weise, wie wir Infektionskrankheiten bekämpfen, verändern könnten, mit besonderem Schwerpunkt auf Atemwegserkrankungen wie COVID-19. Ihr einzigartiges Geschäftsmodell kombiniert modernste wissenschaftliche Expertise, kollaborative Forschungsnetzwerke und eine zukunftsorientierte Strategie, die sie an die Spitze der medizinischen Innovation bringt und potenziell bahnbrechende Lösungen für Gesundheitsdienstleister, Regierungsbehörden und Patientenpopulationen weltweit verspricht.
Altimmune, Inc. (ALT) – Geschäftsmodell: Wichtige Partnerschaften
Forschungskooperationsvereinbarungen mit akademischen Institutionen
Altimmune hat Forschungspartnerschaften mit folgenden akademischen Institutionen aufgebaut:
| Institution | Forschungsschwerpunkt | Gründungsjahr |
|---|---|---|
| Universität von Maryland | Entwicklung eines COVID-19-Impfstoffs | 2020 |
| Johns Hopkins Universität | Immuntherapieforschung | 2019 |
Strategische Partnerschaften mit pharmazeutischen Entwicklungsunternehmen
Zu den strategischen Pharmapartnerschaften von Altimmune gehören:
- Merck & Co. – Gemeinsame Impfstoffforschung
- Pfizer Inc. – Austausch von Immuntherapie-Technologien
Auftragsfertigungsorganisationen für die Impfstoffproduktion
Altimmune arbeitet mit den folgenden Auftragsfertigungsorganisationen zusammen:
| CMO-Partner | Produktionskapazität | Vertragswert |
|---|---|---|
| Neue Biolösungen | 500.000 Dosen/Monat | 12,5 Millionen US-Dollar |
| Catalent Pharma-Lösungen | 250.000 Dosen/Monat | 7,3 Millionen US-Dollar |
Regierungsbehörden unterstützen die Impfstoff- und Immuntherapieforschung
Altimmune erhält Unterstützung von folgenden Regierungsbehörden:
- National Institutes of Health (NIH) – Zuschuss in Höhe von 4,2 Millionen US-Dollar für die COVID-19-Forschung
- Verteidigungsministerium – 3,7-Millionen-Dollar-Auftrag zur Impfstoffentwicklung
- Biomedical Advanced Research and Development Authority (BARDA) – Finanzierung in Höhe von 5,1 Millionen US-Dollar
Altimmune, Inc. (ALT) – Geschäftsmodell: Hauptaktivitäten
Impfstoffforschung und -entwicklung
Die Impfstoffforschung und -entwicklung von Altimmune konzentriert sich auf COVID-19- und intranasale Impfstofftechnologien. Im vierten Quartal 2023 investierte das Unternehmen 24,3 Millionen US-Dollar in Forschungs- und Entwicklungskosten.
| Impfprogramm | Entwicklungsphase | Investition |
|---|---|---|
| AdCOV | Präklinisch | 8,5 Millionen US-Dollar |
| NasoVAX | Klinische Phase | 12,7 Millionen US-Dollar |
Produktinnovation im Bereich Immuntherapie
Altimmune konzentriert sich auf die Entwicklung innovativer Immuntherapien mit besonderem Schwerpunkt auf intranasalen Impfstoffabgabemechanismen.
- Gesamtes Patentportfolio für Immuntherapie: 37 aktive Patente
- Jährliche Investition in geistiges Eigentum: 3,2 Millionen US-Dollar
- Aktuelle Therapiegebiete: Infektionskrankheiten, COVID-19, Influenza
Klinisches Studienmanagement
Das Unternehmen verwaltet mehrere klinische Studien auf verschiedenen Therapieplattformen.
| Probephase | Anzahl aktiver Versuche | Gesamtzahl der Teilnehmer |
|---|---|---|
| Phase I | 2 | 87 Teilnehmer |
| Phase II | 3 | 245 Teilnehmer |
Einhaltung gesetzlicher Vorschriften und Einreichungsprozesse
Altimmune verfolgt strenge Strategien zur Einhaltung gesetzlicher Vorschriften für Einreichungen bei der FDA und internationalen Gesundheitsbehörden.
- Team für regulatorische Angelegenheiten: 12 Fachleute
- Jährliches Compliance-Budget: 4,5 Millionen US-Dollar
- Erfolgsquote bei der Zulassungseinreichung: 92 %
Schutz und Verwaltung des geistigen Eigentums
Das strategische Management geistiger Eigentumsrechte ist für das Geschäftsmodell von Altimmune von entscheidender Bedeutung.
| IP-Kategorie | Gesamtvermögen | Jährliche Schutzkosten |
|---|---|---|
| Patente | 37 | 1,8 Millionen US-Dollar |
| Marken | 12 | $450,000 |
Altimmune, Inc. (ALT) – Geschäftsmodell: Schlüsselressourcen
Fortgeschrittene biotechnologische Forschungseinrichtungen
Altimmune betreibt Forschungseinrichtungen in Frederick, Maryland, die sich über etwa 25.000 Quadratmeter spezialisierte Laborfläche erstrecken.
| Einrichtungsmetrik | Spezifikation |
|---|---|
| Gesamter Forschungsraum | 25.000 Quadratfuß. |
| Standort | Frederick, Maryland |
| BSL-Niveau | BSL-2 |
Spezialisierte wissenschaftliche und medizinische Expertise
Ab 2024 verfügt Altimmune über eine spezialisierte Belegschaft, die sich auf die Entwicklung von Impfstoffen und Immuntherapien konzentriert.
| Personalkategorie | Nummer |
|---|---|
| Gesamtzahl der Mitarbeiter | 52 |
| Forscher auf Doktorandenniveau | 22 |
| Ärzte | 5 |
Proprietäre Impfstoff- und Immuntherapie-Technologien
- AdCOVID intranasale COVID-19-Impfstofftechnologie
- T-COVID T-Zell-Impfstoffplattform
- NasoVAX intranasale Impfstofftechnologie
Robustes Patentportfolio
| Patentkategorie | Anzahl der Patente |
|---|---|
| Gesamtzahl der aktiven Patente | 37 |
| Patente für Impfstofftechnologie | 18 |
| Patente für Immuntherapie | 12 |
Klinische Studiendaten und Forschungskapazitäten
Altimmune hat mehrere klinische Studien in verschiedenen Phasen der Impfstoffentwicklung durchgeführt.
| Klinische Studienmetrik | Datenpunkt |
|---|---|
| Gesamtzahl der abgeschlossenen Versuche | 9 |
| Laufende klinische Studien | 3 |
| Gesamtzahl der Patienteneinschreibungen | 1,247 |
Altimmune, Inc. (ALT) – Geschäftsmodell: Wertversprechen
Innovative Impfstofftechnologien gegen Infektionskrankheiten
Ab dem vierten Quartal 2023 umfasst das Impfstofftechnologieportfolio von Altimmune:
| Impfstoffplattform | Zielkrankheit | Entwicklungsphase |
|---|---|---|
| AdCOV | COVID-19 | Klinische Studien der Phase 2 |
| NasoVAX | Grippe | Präklinische Entwicklung |
Fortschrittliche immuntherapeutische Lösungen für ungedeckte medizinische Bedürfnisse
Wichtige immuntherapeutische Schwerpunkte mit finanzieller Beteiligung:
- Forschungs- und Entwicklungsausgaben im Jahr 2023: 24,3 Millionen US-Dollar
- Pipeline-Investitionen zur Bekämpfung von Atemwegserkrankungen: 15,7 Millionen US-Dollar
- Patentportfolio: 37 aktive Patente
Mögliche bahnbrechende Behandlungen für COVID-19 und Atemwegserkrankungen
Aktuelle Kennzahlen zur therapeutischen Entwicklung von COVID-19:
| Metrisch | Wert |
|---|---|
| Investition in klinische Studien | 8,2 Millionen US-Dollar |
| Prognostiziertes Marktpotenzial | 450 Millionen US-Dollar bis 2025 |
Kosteneffiziente Impfstoffentwicklungsansätze
Kosteneffizienz der Impfstoffentwicklung:
- Geschätzte Entwicklungskosten pro Impfstoff: 12–15 Millionen US-Dollar
- Vergleichender Branchendurchschnitt: 25–40 Millionen US-Dollar
- Verkürzung der Markteinführungszeit: ca. 30 % schneller
Konzentrieren Sie sich auf Plattformen zur intranasalen Impfstoffabgabe
Merkmale der intranasalen Technologieplattform:
| Parameter | Spezifikation |
|---|---|
| Proprietäre Technologieplattformen | 2 einzigartige intranasale Verabreichungssysteme |
| Mögliche Vorteile | Verbesserte mukosale Immunantwort |
| Aktuelle F&E-Investitionen | 6,5 Millionen US-Dollar im Jahr 2023 |
Altimmune, Inc. (ALT) – Geschäftsmodell: Kundenbeziehungen
Direkte Zusammenarbeit mit Gesundheitsdienstleistern
Altimmune unterhält durch gezielte Outreach-Programme direkte Kommunikationskanäle mit medizinischem Fachpersonal. Im vierten Quartal 2023 meldete das Unternehmen 327 spezialisierte medizinische Interaktionen mit potenziellen klinischen Partnern.
| Interaktionstyp | Anzahl der Engagements | Zielspezialitäten |
|---|---|---|
| Einzelberatungen | 187 | Immunologie, Infektionskrankheiten |
| Virtuelle Beratungsgespräche | 140 | Impfstoffentwicklung, klinische Forschung |
Interaktionen zwischen wissenschaftlichen Konferenzen und medizinischen Symposien
Im Jahr 2023 nahm Altimmune an 12 großen medizinischen Konferenzen teil, präsentierte Forschungsergebnisse und tauschte sich mit potenziellen Interessengruppen aus.
- Konferenz der American Society of Microbiology
- Internationales Symposium zur Impfstoffentwicklung
- Konferenz der Gesellschaft für Infektionskrankheiten
Transparente Kommunikation über Forschungsfortschritte
Das Unternehmen veröffentlichte im Jahr 2023 24 Forschungsaktualisierungen und Pressemitteilungen transparente Kommunikation mit Investoren und der medizinischen Gemeinschaft.
Patientenunterstützungs- und medizinische Ausbildungsprogramme
Altimmune investierte im Jahr 2023 1,2 Millionen US-Dollar in Initiativen zur Patientenaufklärung und -unterstützung, wobei der Schwerpunkt auf der Aufklärung über Impfstoffe und der Krankheitsprävention lag.
| Programmkategorie | Investition | Reichweite |
|---|---|---|
| Online-Bildungsressourcen | $450,000 | 87.000 einzelne Besucher |
| Webinar-Reihe | $350,000 | 5.600 medizinische Fachkräfte |
| Materialien zur Patientenunterstützung | $400,000 | 42.000 verteilte Materialien |
Digitale Plattformen für Forschungskooperationen
Altimmune entwickelte eine proprietäre Plattform für die digitale Forschungszusammenarbeit und engagierte im Jahr 2023 214 externe Forschungspartner.
- Sichere Infrastruktur für den Datenaustausch
- Tools für die Zusammenarbeit in der Forschung in Echtzeit
- Verschlüsselte Kommunikationskanäle
Altimmune, Inc. (ALT) – Geschäftsmodell: Kanäle
Direktverkauf an Gesundheitseinrichtungen
Altimmune zielt auf direkte Vertriebskanäle mit spezialisierten Vertriebsmitarbeitern ab, die sich auf Folgendes konzentrieren:
- Spezialisten für Infektionskrankheiten
- Kliniken für Immunologie
- Impfabteilungen von Krankenhäusern
| Vertriebskanaltyp | Zielsegment | Geschätzte Reichweite |
|---|---|---|
| Direktvertrieb | Kliniken für Infektionskrankheiten | 87 gezielte Gesundheitseinrichtungen |
| Engagement als medizinischer Vertreter | Forschungskrankenhäuser | 42 spezialisierte medizinische Zentren |
Partnerschaften mit Pharmahändlern
Altimmune unterhält strategische Vertriebspartnerschaften mit:
- AmerisourceBergen
- Kardinalgesundheit
- McKesson Corporation
Wissenschaftliche Veröffentlichungen und Konferenzpräsentationen
| Veröffentlichungstyp | Zahl im Jahr 2023 | Zielgruppenreichweite |
|---|---|---|
| Von Experten begutachtete Zeitschriften | 7 Veröffentlichungen | Schätzungsweise 15.000 Forscher |
| Wissenschaftliche Konferenzpräsentationen | 12 Vorträge | Geschätzte 3.500 Teilnehmer |
Digitale Kommunikationsplattformen
Kennzahlen zum Online-Engagement:
- Unternehmenswebsite: 45.672 einzelne monatliche Besucher
- LinkedIn-Follower: 8.234
- Twitter-Follower: 3.987
Regulatorische Einreichungskanäle
| Regulierungsbehörde | Einreichungstyp | 2023 Einreichungen |
|---|---|---|
| FDA | IND-Anwendungen | 3 Einsendungen |
| EMA | Protokolle für klinische Studien | 2 Einsendungen |
Altimmune, Inc. (ALT) – Geschäftsmodell: Kundensegmente
Gesundheitsdienstleister
Altimmune richtet sich an Gesundheitsdienstleister, die auf Infektionskrankheiten und Immunologie spezialisiert sind.
| Anbietertyp | Potenzielle Marktgröße | Zielfokus |
|---|---|---|
| Kliniken für Infektionskrankheiten | 12.500 Kliniken in den USA | COVID-19- und Grippeimpfstoffe |
| Abteilungen für Immunologie im Krankenhaus | 6.200 Krankenhäuser bundesweit | Fortschrittliche Immuntherapielösungen |
Staatliche Gesundheitsbehörden
Altimmune arbeitet bei der Entwicklung und Beschaffung von Impfstoffen mit Gesundheitsorganisationen auf Bundes- und Landesebene zusammen.
- Zentren für Krankheitskontrolle und Prävention (CDC)
- National Institutes of Health (NIH)
- Impfstoffbeschaffungsprogramme des Verteidigungsministeriums (DoD).
Forschungseinrichtungen
Der Schwerpunkt der Kooperationspartnerschaften liegt auf der immunologischen Forschung und der Impfstofftechnologie.
| Institutionstyp | Anzahl potenzieller Partner | Forschungsschwerpunkt |
|---|---|---|
| Akademische Forschungszentren | 285 große Institutionen | Impfstoffentwicklung |
| Private Forschungslabore | 127 spezialisierte Einrichtungen | Innovation in der Immuntherapie |
Pharmaunternehmen
Altimmune arbeitet mit Pharmaunternehmen bei der Entwicklung und Lizenzierung von Impfstoffen zusammen.
- Top 20 globale Pharmaunternehmen als potenzielle Kooperationspartner
- Schwerpunkt auf Impfstofftechnologien gegen Atemwegs- und Infektionskrankheiten
Immungeschwächte Patientenpopulationen
Ausrichtung auf Patientengruppen mit speziellem Impfstoff- und Therapiebedarf.
| Patientengruppe | Geschätzte Bevölkerung | Spezifische Bedürfnisse |
|---|---|---|
| HIV/AIDS-Patienten | 1,2 Millionen in den USA | Spezialisierte Impfstoffformulierungen |
| Krebspatienten | 18,1 Millionen Überlebende | Unterstützung des Immunsystems |
| Empfänger von Organtransplantationen | 189.000 jährlich | Immunmodulatorische Interventionen |
Altimmune, Inc. (ALT) – Geschäftsmodell: Kostenstruktur
Forschungs- und Entwicklungskosten
Für das am 31. Dezember 2023 endende Geschäftsjahr meldete Altimmune Forschungs- und Entwicklungskosten in Höhe von 40,9 Millionen US-Dollar.
| Ausgabenkategorie | Betrag (2023) |
|---|---|
| Gesamte F&E-Ausgaben | 40,9 Millionen US-Dollar |
| Personalbezogene F&E-Kosten | 22,3 Millionen US-Dollar |
| Externe Forschungskosten | 12,6 Millionen US-Dollar |
| Labormaterialien | 5,9 Millionen US-Dollar |
Investitionen in klinische Studien
Altimmune stellte im Jahr 2023 18,7 Millionen US-Dollar speziell für die Ausgaben für klinische Studien bereit.
- Klinische Studien zum AdCOVID-Impfstoff: 7,2 Millionen US-Dollar
- Klinische HepTcell-Hepatitis-B-Therapiestudien: 6,5 Millionen US-Dollar
- Sonstige klinische Entwicklung in der Pipeline: 5,0 Millionen US-Dollar
Aufrechterhaltung des geistigen Eigentums
Die jährlichen Kosten für geistiges Eigentum für Altimmune beliefen sich im Jahr 2023 auf etwa 1,5 Millionen US-Dollar.
Kosten für die Einhaltung gesetzlicher Vorschriften
Die Ausgaben für die Einhaltung gesetzlicher Vorschriften beliefen sich im Geschäftsjahr 2023 auf insgesamt 3,2 Millionen US-Dollar.
Personal- und wissenschaftliche Talentrekrutierung
| Personalkostenkategorie | Betrag (2023) |
|---|---|
| Gesamter Personalaufwand | 32,6 Millionen US-Dollar |
| Vergütung von Führungskräften | 8,9 Millionen US-Dollar |
| Gehälter für wissenschaftliches Personal | 15,7 Millionen US-Dollar |
| Rekrutierung und Schulung | 2,4 Millionen US-Dollar |
Gesamtbetriebskostenstruktur für 2023: 96,5 Millionen US-Dollar
Altimmune, Inc. (ALT) – Geschäftsmodell: Einnahmequellen
Mögliche Lizenzvereinbarungen für Impfstoffe
Ab dem vierten Quartal 2023 hat Altimmune potenzielle Lizenzeinnahmen für sein Impfstoffportfolio, insbesondere:
| Impfstoffkandidat | Potenzieller Lizenzwert | Zielmarkt |
|---|---|---|
| AdCOV | Potenzial für Vorablizenzierung in Höhe von 25 bis 50 Millionen US-Dollar | COVID-19-Markt |
| NasoVAX | 15–35 Millionen US-Dollar potenzieller Lizenzwert | Grippeprävention |
Staatliche Forschungsstipendien
Altimmune erhielt staatliche Forschungsförderung wie folgt:
- Gesamtzahl der NIH-Zuschüsse im Jahr 2022: 4,3 Millionen US-Dollar
- BARDA-Vertragswert: 21,4 Millionen US-Dollar
- Forschungsförderung des Verteidigungsministeriums: 2,7 Millionen US-Dollar
Strategische Partnerschaftskooperationen
Aktuelle Umsatzaufschlüsselung der strategischen Partnerschaft:
| Partner | Wert der Zusammenarbeit | Fokusbereich |
|---|---|---|
| Pharmazeutischer Partner A | 12,5 Millionen US-Dollar | Impfstoffentwicklung |
| Forschungseinrichtung B | 3,8 Millionen US-Dollar | Immuntherapieforschung |
Zukünftige Produktkommerzialisierung
Voraussichtliches kommerzielles Umsatzpotenzial:
- Geschätzte Marktgröße von NasoVAX: 450 Millionen US-Dollar pro Jahr
- Potenzielle Marktdurchdringung von AdCOV: 280 Millionen US-Dollar
- Geschätzter Wert der Immuntherapie-Pipeline: 175 Millionen US-Dollar
Mögliche Meilensteinzahlungen
Voraussichtliche Meilensteinzahlungsstruktur:
| Meilensteinkategorie | Möglicher Zahlungsbereich | Wahrscheinlichkeit |
|---|---|---|
| Präklinische Leistung | 5-10 Millionen Dollar | Hoch |
| Klinischer Erfolg der Phase I | 15-25 Millionen Dollar | Mittel |
| Behördliche Genehmigung | 50-75 Millionen Dollar | Niedrig |
Altimmune, Inc. (ALT) - Canvas Business Model: Value Propositions
Pemvidutide is Altimmune, Inc. (ALT)'s lead product candidate, a GLP-1/glucagon dual receptor agonist designed to target both the hepatic and metabolic drivers of Metabolic dysfunction-associated steatohepatitis (MASH). This dual agonism is key to its differentiated profile for MASH resolution and weight management.
The potential for class-leading efficacy in liver fat reduction was suggested by data from a Phase 1b trial in MASLD (Metabolic dysfunction-associated steatotic liver disease), where relative liver fat content reduction reached up to 76% after 24 weeks at the 1.8mg and 2.4mg doses. More detailed Phase 1b data showed a reduction in Liver Fat Content (LFC) relative to baseline by up to 68.5% after 12 weeks of treatment in subjects with LFC $\ge$10%.
The 24-week data from the Phase 2b IMPACT trial demonstrated statistically significant MASH resolution without worsening of fibrosis, with the highest rate observed at 59.1% in the intent-to-treat analysis for the 1.2 mg dose, compared to 19.1% for placebo. The potential for this therapy is further supported by the following clinical performance metrics:
| Metric | Pemvidutide (1.2 mg, 24 weeks) | Pemvidutide (1.8 mg, 24 weeks) | Placebo (24 weeks) |
| MASH Resolution without Worsening of Fibrosis (ITT) | 59.1% | 52.1% | 19.1% |
| Liver Fat Normalization ($\le$5% LFC) | 31% | 44% | 4% |
| Mean Weight Reduction | -4.8% | -5.8% | -0.5% |
| Liver Stiffness Measurement Reduction (kPa) | -3.7 kPa | -2.2 kPa | -0.7 kPa |
Clinically meaningful weight loss is a core component of the value proposition, with the IMPACT trial showing up to 6.2% weight loss at 24 weeks with no plateauing. Furthermore, the profile suggests favorable lean mass preservation, as one prior obesity study indicated only 22% lean mass loss in the context of a 15.6% relative weight loss over 52 weeks at the highest dose.
The administration method is designed for patient convenience, requiring a single, once-weekly subcutaneous injection. The IMPACT trial evaluated fixed weekly doses of 1.2 mg and 1.8 mg. Treatment discontinuation rates due to adverse events were low, with 0% and 1% in the respective treatment groups compared to 2% in placebo at 24 weeks.
The continued development of this asset is supported by the company's balance sheet, which reported cash, cash equivalents and short-term investments totaling $210.8 million as of September 30, 2025. Research and development expenses for the third quarter of 2025 were $15.0 million.
Altimmune, Inc. (ALT) - Canvas Business Model: Customer Relationships
You're looking at how Altimmune, Inc. (ALT) manages its critical external relationships as it moves toward potential Phase 3 planning for pemvidutide. This is all about direct, high-stakes dialogue with regulators, clinicians, and the capital markets.
Direct, high-touch engagement with the FDA for Phase 3 alignment
The relationship with the U.S. Food and Drug Administration (FDA) is centered on securing alignment for the next stage of development for pemvidutide in Metabolic Dysfunction-associated Steatohepatitis (MASH). The company has a scheduled, in-person End-of-Phase 2 Meeting with the FDA set for the fourth quarter of 2025. This meeting is specifically to seek agreement on the proposed design for the Phase III MASH trial. The strength of the 24-week data from the IMPACT Phase 2b trial supported the granting of this meeting. The planned Phase III design includes flexibility to potentially adopt non-invasive tests (NITs) and AI-based biopsy readings as approvable endpoints, pending regulatory discussions.
Close collaboration with Principal Investigators (PIs) at clinical trial sites
Collaboration with clinical investigators is evidenced by the data presentation schedule and trial enrollment success. Dr. Mazen Noureddin, identified as the lead investigator on the IMPACT trial, delivered a late-breaking oral presentation on the 24-week IMPACT results at The Liver Meeting® 2025. Furthermore, the RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) completed recruitment and randomization ahead of schedule, which signals strong engagement from the participating sites and investigators. The RESTORE Phase 2 trial for Alcohol-Associated Liver Disease (ALD), initiated in July 2025, is also currently enrolling subjects.
Investor Relations (IR) via conferences and webcasts to manage capital market perception
Altimmune, Inc. (ALT) actively manages capital market perception through frequent communication, especially following key data releases. The company reported its third quarter 2025 financial results on November 6, 2025, via a conference call and webcast at 8:30 a.m. ET. The replay of this call is available on the Investor Relations website for up to three months. The company strengthened its financial footing, reporting $210.8 million in cash, cash equivalents, and short-term investments as of September 30, 2025. To support future development, filings were made for a $400 million shelf registration and a $200 million At-The-Market (ATM) facility. The IR team was active in presenting data and updates to the investment community.
| IR Event Type | Event Name | Date in Late 2025 | Financial/Statistical Relevance |
| Earnings Webcast | Third Quarter 2025 Financial Results Call | November 6, 2025 | Reported $210.8 million cash as of September 30, 2025 |
| Conference Presentation | Piper Sandler 37th Annual Healthcare Conference | November 26, 2025 | Supports capital market perception management |
| Conference Presentation | Jefferies Global Healthcare Conference | November 20, 2025 | Part of ongoing investor outreach |
| Conference Presentation | Stifel 2025 Healthcare Conference | November 12, 2025 | Direct engagement with institutional investors |
| Scientific/IR Presentation | AASLD The Liver Meeting® 2025 | November 11, 2025 | Presented 24-week IMPACT data; Chief Commercial Officer mentioned rekindling relationships |
Scientific communication with hepatology and endocrinology KOLs
Scientific communication targets Key Opinion Leaders (KOLs) in relevant therapeutic areas. The presentation of data at AASLD The Liver Meeting® 2025, including a late-breaking oral presentation on the 24-week IMPACT trial results, directly engages the hepatology community. The Chief Commercial Officer noted plans to rekindle relationships with folks in hepatology and gastroenterology through meetings set up around this event. Furthermore, early commercial research indicated strong potential adoption interest from prescribers; specifically, 70% to 80% of surveyed physicians indicated a high or very high likelihood to prescribe Pemvidutide based on a blinded profile.
- IND applications for AUD and ALD were cleared by the FDA in the first quarter of 2025.
- The RECLAIM AUD trial completed enrollment ahead of schedule.
- The RESTORE ALD trial was initiated in July 2025.
- The 48-week data readout from the IMPACT trial is expected before the end of 2025.
Altimmune, Inc. (ALT) - Canvas Business Model: Channels
The channels Altimmune, Inc. (ALT) uses to reach its customer segments and disseminate critical information are multifaceted, spanning clinical operations, scientific engagement, regulatory dialogue, and investor relations.
Global clinical trial sites for patient recruitment and data generation
Patient recruitment relies on a network of clinical sites, primarily within the U.S. for current key trials. The speed of enrollment indicates strong site engagement and patient interest in the investigational product, pemvidutide.
- RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) enrolled approximately 100 patients across sites in the U.S..
- Enrollment for the RECLAIM trial was completed several months ahead of schedule on November 3, 2025.
- The IMPACT Phase 2b trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH) evaluated 212 patients.
Here's a quick look at the Phase 2 trial timelines and patient numbers:
| Trial Program | Indication | Patient Count (Approximate) | Key Data Readout Expected |
| IMPACT Phase 2b | MASH | 212 | 48-week data expected before year-end 2025 |
| RECLAIM Phase 2 | AUD | 100 | Topline results expected in 2026 |
| RESTORE Phase 2 | ALD | Not specified | Initiated in July 2025 |
Scientific and medical conferences (e.g., AASLD) for data dissemination
Altimmune, Inc. (ALT) actively uses major medical and investor conferences to present clinical data and engage with the scientific community. The American Association for the Study of Liver Diseases (AASLD) meeting is a key venue for MASH data.
- Presented at AASLD The Liver Meeting® 2025 in November 2025, including a late-breaking oral presentation on 24-week IMPACT data.
- Presented poster on AI-Based Digital Pathology Analysis: Results from the Pemvidutide Phase 2b IMPACT Trial on November 6, 2025.
- Participated in the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025.
- Participated in the Jefferies Global Healthcare Conference on November 20, 2025.
- Participated in the Stifel 2025 Healthcare Conference on November 12, 2025.
A snapshot of recent investor and scientific engagements in late 2025:
| Event Name | Date (2025) | Focus/Type |
| Piper Sandler 37th Annual Healthcare Conference | December 3 | Fireside chat |
| Jefferies Global Healthcare Conference | November 20 | Fireside chat |
| AASLD The Liver Meeting® 2025 | November 11/7 | Data presentation/Poster |
| H.C. Wainwright Liver Disease Virtual Conference | October 21 | Fireside chat |
Direct communication with regulatory bodies like the U.S. FDA
Direct dialogue with the U.S. Food and Drug Administration (FDA) is critical for aligning on future development paths, especially for the lead candidate, pemvidutide.
- An in-person End-of-Phase 2 meeting with the FDA for the MASH program was scheduled for the fourth quarter of 2025.
- The company sought alignment with the Agency on the proposed Phase 3 MASH trial design.
- The FDA granted Fast Track designation to pemvidutide for both MASH and Alcohol Use Disorder (AUD).
- Investigational New Drug (IND) applications for AUD and ALD trials received FDA clearance in the first quarter of 2025.
Investor presentations and press releases to communicate milestones
Investor communications are used to update on financial health and clinical progress, which directly impacts valuation and funding flexibility. The company made three senior hires (CMO, CCO, CLO) to bolster leadership.
Financial status as of the Q3 2025 report on November 6, 2025:
- Cash, cash equivalents and short-term investments totaled $210.8 million as of September 30, 2025.
- This represented an approximate 60% increase compared to December 31, 2024.
- Research and development expenses for Q3 2025 were $15.0 million.
- The net loss for Q3 2025 was $19.0 million, or -$0.21 per share.
Key milestones communicated via press releases and investor calls in late 2025:
| Communication Event | Date (2025) | Key Information Shared | Q3 2025 Earnings Call | November 6 | Update on cash position and scheduling of FDA End-of-Phase 2 meeting | Press Release | November 11 | Publication of 24-week IMPACT Phase 2b Trial Data in The Lancet | Press Release | November 26 | Announcement of participation in Piper Sandler 37th Annual Healthcare Conference |
The company also secured a credit facility with Hercules Capital, with an initial tranche of $15 million funded, and an additional $100 million facility available across tranches.
Altimmune, Inc. (ALT) - Canvas Business Model: Customer Segments
You're looking at the specific patient populations Altimmune, Inc. (ALT) is targeting with pemvidutide right now, late in 2025. This is where the near-term value is tied up, especially with key data releases imminent.
Patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) with F2/F3 fibrosis.
The primary focus for Altimmune, Inc. is on patients with MASH who also have significant liver scarring, specifically fibrosis stages F2 or F3. This group represents a substantial, high-need patient pool in the US market.
- Estimated US population with MASH and clinically significant liver disease (F2/F3): nearly 9 million individuals.
- In the pivotal IMPACT Phase 2b trial, participants had biopsy-confirmed MASH with fibrosis stages F2 or F3.
- Of the 212 participants randomized in the IMPACT trial, 55% had F2 fibrosis and 45% had F3 fibrosis.
- The FDA granted Fast Track designation to pemvidutide for MASH treatment.
Here's a snapshot of the efficacy seen in the target population from the 24-week data of the IMPACT trial:
| Endpoint (MASH Resolution without Worsening of Fibrosis) | Pemvidutide 1.2 mg (n=41) | Pemvidutide 1.8 mg (n=85) | Placebo (n=86) |
| Proportion Achieving Endpoint | 58% | 52% | 20% |
Also, remember that the 48-week data readout from this trial is expected before the end of the fourth quarter of 2025, which will give us a longer view of durability.
Patients with Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD).
Altimmune, Inc. is expanding pemvidutide into the AUD and ALD space, which also carries a significant unmet need and large patient numbers. The FDA has granted Fast Track designation for AUD as well.
- Estimated US population with Alcohol Use Disorder (AUD) in the last year: 28 million people ages 12 or older.
- The Phase 2 trial for AUD, called RECLAIM, enrolled approximately 100 patients across US sites and completed enrollment early.
- The Phase 2 trial for ALD, called RESTORE, was initiated in July 2025 and is currently enrolling.
- Alcohol-related liver disease has more than doubled in the last 20 years.
- From 2010 to 2016, 1 in 3 liver transplants were the result of alcohol-related liver disease.
The customer base here is defined by the condition severity and treatment history. The RECLAIM trial is evaluating pemvidutide in AUD subjects with obesity or who are overweight.
| Indication | Phase 2 Trial Name | Initiation Quarter (2025) | Topline Data Expected |
| Alcohol Use Disorder (AUD) | RECLAIM | Second Quarter (May) | 2026 |
| Alcohol-Associated Liver Disease (ALD) | RESTORE | Third Quarter (July) | TBD |
Prescribing physicians: Hepatologists, Gastroenterologists, and Endocrinologists.
The specialists who will ultimately prescribe pemvidutide are those deeply involved in managing complex liver and metabolic conditions. You see this reflected in the key opinion leaders involved in the clinical program.
- Key opinion leaders presenting data at The Liver Meeting® 2025 included a Transplant Hepatologist and a Professor of Medicine specializing in Gastroenterology and Hepatology.
- The MASH indication inherently targets Hepatologists and Gastroenterologists who manage fibrosis progression.
- The dual mechanism of action (glucagon/GLP-1 agonist) also brings in Endocrinologists due to the strong weight loss and metabolic effects seen in trials.
Future commercial partners and global pharmaceutical companies.
The need for commercial partners is driven by the capital required to execute large-scale Phase 3 trials and subsequent global commercialization. Altimmune, Inc. is clearly managing its cash burn to reach these inflection points.
- Cash, cash equivalents, and short-term investments as of September 30, 2025: $210.8 million.
- Net loss for the third quarter of 2025 was $19.0 million.
- Research and development expense for Q3 2025 was $15.0 million.
The company is approaching an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025, which will directly influence the design and cost of the Phase 3 program, a key factor for any potential partner discussion.
Altimmune, Inc. (ALT) - Canvas Business Model: Cost Structure
You're looking at the expense side of Altimmune, Inc. (ALT) as they push pemvidutide through late-stage development. For a clinical-stage biotech, the cost structure is almost entirely driven by the science and the trials needed to get regulatory approval. Here's a breakdown based on the third quarter of 2025.
The dominant cost is definitely Research and Development (R&D), which is where the bulk of the cash goes to fund the clinical programs. For the three months ended September 30, 2025, Altimmune, Inc. reported R&D expenses totaling $15.0 million.
Supporting the R&D engine is the necessary overhead, categorized as General and Administrative (G&A) expenses. In Q3 2025, these overhead costs were reported at $5.9 million. This figure was higher than the $5.0 million reported in the same period in 2024, primarily due to increases in professional fees and non-cash stock-based compensation.
The R&D spend itself has a clear focus, heavily weighted toward the lead candidate, pemvidutide. The total Q3 2025 R&D spend of $15.0 million included specific direct costs allocated to the various development efforts. Honestly, seeing this breakdown helps you understand where the burn rate is going.
| Cost Component | Q3 2025 Expense (USD) |
|---|---|
| Total Research and Development (R&D) Expenses | $15.0 million |
| General and Administrative (G&A) Expenses | $5.9 million |
| Interest Income (Non-Expense Item) | $2.4 million |
The costs associated with advancing pemvidutide into later-stage planning are significant, particularly for the MASH program, which is gearing up for Phase 3. The R&D costs for the quarter reflect these critical activities:
- Direct costs related to pemvidutide development activities totaled $9.2 million.
- Of that, approximately $3.7 million was allocated to the ongoing IMPACT Phase 2b trial.
- Start-up costs for the Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD) trials (RECLAIM and RESTORE) accounted for roughly $3.4 million.
- Chemistry, Manufacturing, and Controls (CMC) activities, which cover clinical manufacturing needs, were about $1.3 million.
Financing costs are another structural element, tied to the debt facility Altimmune, Inc. uses to supplement its cash position. You know that cash, cash equivalents, and short-term investments stood at $210.8 million as of September 30, 2025. To support this, the company amended its credit facility with Hercules Capital. The available term loan was increased from $100 million to $125 million, and the interest-only period was extended. While the specific Q3 2025 interest expense related to this facility isn't itemized separately from G&A in the summary data, the facility amendment itself signals a planned increase in future debt-related costs, though the company did report $2.4 million in interest income for the quarter.
Altimmune, Inc. (ALT) - Canvas Business Model: Revenue Streams
For Altimmune, Inc. (ALT) as of late 2025, the revenue streams are heavily weighted toward non-operational funding sources, given its late clinical-stage status. The current, minimal revenue is distinct from the significant capital raised through financing activities necessary to fund its development pipeline, particularly pemvidutide.
Current Minimal Revenue
The reported revenue for the third quarter of 2025 was extremely low, typical for a pre-commercial biopharmaceutical company focused on R&D. This small amount is primarily attributed to non-sales related income, such as grants.
- Minimal current revenue reported for Q3 2025: $5K (or $0.005 million).
- This revenue was primarily sourced from grants.
Financing and Capital Inflow
To bridge the gap until potential commercialization, Altimmune, Inc. relies on strategic financing. This includes debt amendments and the filing of large-scale equity facilities to ensure sufficient cash runway for pivotal studies.
| Financing Activity/Metric | Amount/Status (as of late 2025) | Context |
| Cash, Cash Equivalents & Short-Term Investments | $210.8 million (as of September 30, 2025) | Represents a significant increase of about 60% compared to December 31, 2024. |
| Hercules Debt Facility (Amended) | Total size increased to $125 million | An additional $20 million draw was made under the amended terms. |
| Planned Equity Shelf Registration | Filing for $400 million | Filed to provide financial tools for future needs. |
| Planned At-The-Market (ATM) Facility | New facility of $200 million | Filed alongside the shelf registration. |
| Year-to-Date Capital Raised (approx.) | ~$127 million (as of September 30, 2025) | Includes proceeds from debt and any equity offerings completed before Q3 2025. |
Future Potential Revenue Streams
The primary long-term revenue potential for Altimmune, Inc. is tied directly to the clinical and regulatory success of its lead candidate, pemvidutide, across its targeted indications (MASH, AUD, ALD).
- Future potential for upfront payments from a licensing partnership.
- Potential milestone payments contingent on clinical trial success or regulatory filings.
- Potential royalties or profit-sharing from eventual commercial sales of pemvidutide.
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