Altimmune, Inc. (ALT) Business Model Canvas

Altimmune, Inc. (ALT): Canvas du modèle d'entreprise [Jan-2025 Mis à jour]

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Altimmune, Inc. (ALT) émerge comme une entreprise de biotechnologie révolutionnaire révolutionnant le développement des vaccins et l'immunothérapie grâce à son approche innovante pour relever les défis médicaux non satisfaits. En tirant parti des capacités de recherche avancées et des partenariats stratégiques, les technologies pionnières des vaccins intranasaux qui pourraient potentiellement transformer la façon dont nous luttons sur les maladies infectieuses, avec un accent particulier sur les conditions respiratoires comme Covid-19. Leur modèle commercial unique combine une expertise scientifique de pointe, des réseaux de recherche collaboratifs et une stratégie avant-gardiste qui les positionne à l'avant-garde de l'innovation médicale, promettant des solutions potentiellement révolutionnaires pour les prestataires de soins de santé, les agences gouvernementales et les populations de patients dans le monde entier.


Altimmune, Inc. (ALT) - Modèle d'entreprise: partenariats clés

Accords de recherche collaborative avec les établissements universitaires

Altimmune a établi des partenariats de recherche avec les établissements universitaires suivants:

Institution Focus de recherche Année établie
Université du Maryland Développement du vaccin Covid-19 2020
Université Johns Hopkins Recherche d'immunothérapie 2019

Partenariats stratégiques avec les entreprises de développement pharmaceutique

Les partenariats pharmaceutiques stratégiques d'Altimmune comprennent:

  • Miserrer & Co. - Recherche de vaccin collaborative
  • Pfizer Inc. - Échange de technologies d'immunothérapie

Organisations de fabrication de contrats pour la production de vaccins

Altimmune collabore avec les organisations de fabrication contractuelles suivantes:

Partenaire CMO Capacité de fabrication Valeur du contrat
Biosolutions émergentes 500 000 doses / mois 12,5 millions de dollars
Solutions pharmatriques catalennes 250 000 doses / mois 7,3 millions de dollars

Les agences gouvernementales soutenant la recherche sur les vaccins et l'immunothérapie

Altimmune reçoit le soutien des agences gouvernementales suivantes:

  • National Institutes of Health (NIH) - 4,2 millions de dollars subvention pour la recherche Covid-19
  • Département de la Défense - Contrat de 3,7 millions de dollars pour le développement des vaccins
  • Biomedical Advanced Research and Development Authority (BARDA) - Financement de 5,1 millions de dollars

Altimmune, Inc. (ALT) - Modèle d'entreprise: activités clés

Recherche et développement des vaccins

La R&D vaccinale d'Altimmune se concentre sur les technologies Covid-19 et Intranasal Vaccin. Au quatrième trimestre 2023, la société a investi 24,3 millions de dollars dans les frais de recherche et de développement.

Programme de vaccination Étape de développement Investissement
Adcov Préclinique 8,5 millions de dollars
Nasovax Phase clinique 12,7 millions de dollars

Innovation de produit d'immunothérapie

Almmune se concentre sur le développement d'immunothérapies innovantes avec un accent spécifique sur les mécanismes d'administration des vaccins intranasaux.

  • Portefeuille total des brevets d'immunothérapie: 37 brevets actifs
  • Investissement annuel sur la propriété intellectuelle: 3,2 millions de dollars
  • Zones thérapeutiques actuelles: maladies infectieuses, Covid-19, grippe

Gestion des essais cliniques

La société gère plusieurs essais cliniques sur différentes plateformes thérapeutiques.

Phase de procès Nombre d'essais actifs Total des participants
Phase I 2 87 participants
Phase II 3 245 participants

Processus de conformité et de soumission réglementaires

Altimmune maintient des stratégies de conformité réglementaire rigoureuses pour les soumissions de la FDA et des autorités internationales de la santé.

  • Équipe des affaires réglementaires: 12 professionnels
  • Budget de conformité annuel: 4,5 millions de dollars
  • Taux de réussite de la soumission réglementaire: 92%

Protection et gestion de la propriété intellectuelle

La gestion stratégique des droits de propriété intellectuelle est essentielle au modèle commercial d'Altimmune.

Catégorie IP Actif total Coût de protection annuel
Brevets 37 1,8 million de dollars
Marques 12 $450,000

Altimmune, Inc. (ALT) - Modèle d'entreprise: Ressources clés

Installations de recherche avancée en biotechnologie

Altimmune exploite des installations de recherche situées à Frederick, Maryland, couvrant environ 25 000 pieds carrés d'espace de laboratoire spécialisé.

Métrique de l'installation Spécification
Espace de recherche total 25 000 pieds carrés.
Emplacement Frederick, Maryland
Niveau BSL Bsl-2

Expertise scientifique et médicale spécialisée

Depuis 2024, AlTmune maintient une main-d'œuvre spécialisée axée sur le développement des vaccins et de l'immunothérapie.

Catégorie de personnel Nombre
Total des employés 52
Chercheurs de doctorat 22
Médecins 5

Technologies de vaccin et d'immunothérapie propriétaires

  • Adcovid Intranasal Covid-19 Vaccin Technologie
  • Plateforme de vaccin contre les cellules T-Covid T
  • Technologie de vaccin intranasal Nasovax

Portefeuille de brevets robuste

Catégorie de brevet Nombre de brevets
Brevets actifs totaux 37
Brevets technologiques de vaccination 18
Brevets d'immunothérapie 12

Données d'essai cliniques et capacités de recherche

Altimmune a mené de multiples essais cliniques à travers diverses étapes de développement des vaccins.

Métrique d'essai clinique Point de données
Essais totaux terminés 9
Essais cliniques en cours 3
Inscription totale 1,247

Altimmune, Inc. (ALT) - Modèle d'entreprise: propositions de valeur

Technologies de vaccin innovantes ciblant les maladies infectieuses

Depuis le Q4 2023, le portefeuille de la technologie des vaccins d'Altimmune comprend:

Plate-forme vaccinale Maladie cible Étape de développement
Adcov COVID 19 Essais cliniques de phase 2
Nasovax Grippe Développement préclinique

Solutions immunothérapeutiques avancées pour les besoins médicaux non satisfaits

Messeaux de mise au point immunothérapeutiques clés avec investissement financier:

  • Dépenses de recherche et développement en 2023: 24,3 millions de dollars
  • Investissement de pipeline ciblant les maladies respiratoires: 15,7 millions de dollars
  • Portefeuille de brevets: 37 brevets actifs

Traitements de percés potentiels pour Covid-19 et Temps respiratoires

Métriques de développement thérapeutique Covid-19 actuelles:

Métrique Valeur
Investissement en essai clinique 8,2 millions de dollars
Potentiel de marché projeté 450 millions de dollars d'ici 2025

Approches de développement des vaccins rentables

CONSTACE DE DÉVELOPPEMENT VACCINE:

  • Coût de développement estimé par vaccin: 12 à 15 millions de dollars
  • Moyenne de l'industrie comparative: 25 à 40 millions de dollars
  • Réduction du délai de marché: environ 30% plus rapidement

Concentrez-vous sur les plates-formes de livraison de vaccins intranasaux

Caractéristiques de la plate-forme technologique intranasale:

Paramètre Spécification
Plateformes technologiques propriétaires 2 systèmes de livraison intranasaux uniques
Avantages potentiels Amélioration de la réponse immunitaire muqueuse
Investissement actuel de R&D 6,5 millions de dollars en 2023

Altimmune, Inc. (ALT) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les prestataires de soins de santé

Altimmune maintient les canaux de communication directs avec les professionnels de la santé grâce à des programmes de sensibilisation ciblés. Au quatrième trimestre 2023, la société a signalé 327 interactions médicales spécialisées avec des partenaires cliniques potentiels.

Type d'interaction Nombre d'engagements Target Specialties
Consultations individuelles 187 Immunologie, maladies infectieuses
Réunions de conseil virtuel 140 Développement de vaccins, recherche clinique

Interactions de conférence scientifique et de symposium médical

En 2023, Almmune a participé à 12 grandes conférences médicales, présentant des résultats de recherche et s'engageant avec les parties prenantes potentielles.

  • Conférence de la société américaine de microbiologie
  • Symposium international de développement des vaccins
  • Conférence de la Société des maladies infectieuses

Communication transparente sur les progrès de la recherche

La société a publié 24 mises à jour de recherche et communiqués de presse en 2023, en maintenant communication transparente avec les investisseurs et la communauté médicale.

Programmes de soutien aux patients et à l'éducation médicale

Altimune a investi 1,2 million de dollars dans les initiatives d'éducation et de soutien aux patients en 2023, en se concentrant sur la sensibilisation aux vaccins et la prévention des maladies.

Catégorie de programme Investissement Atteindre
Ressources éducatives en ligne $450,000 87 000 visiteurs uniques
Webinaire Series $350,000 5 600 professionnels de la santé
Matériel de soutien des patients $400,000 42 000 matériaux distribués

Plateformes numériques pour la collaboration de recherche

Altimune a développé une plate-forme de collaboration de recherche numérique propriétaire, engageant 214 partenaires de recherche externes en 2023.

  • Infrastructure de partage de données sécurisée
  • Outils de collaboration de recherche en temps réel
  • Canaux de communication cryptés

Altimmune, Inc. (ALT) - Modèle d'entreprise: canaux

Ventes directes vers les institutions de soins de santé

Almmune cible les canaux de vente directs avec des représentants commerciaux spécialisés en se concentrant sur:

  • Spécialistes des maladies infectieuses
  • Cliniques d'immunologie
  • Services d'immunisation à l'hôpital
Type de canal de vente Segment cible Portée estimée
Force de vente directe Cliniques de maladies infectieuses 87 institutions de soins de santé ciblés
Engagement des représentants médicaux Hôpitaux de recherche 42 centres médicaux spécialisés

Partenariats avec des distributeurs pharmaceutiques

Altimmune maintient des partenariats de distribution stratégique avec:

  • Amerisourcebergen
  • Santé cardinale
  • McKesson Corporation

Publications scientifiques et présentations de la conférence

Type de publication Numéro en 2023 Poutenir
Journaux évalués par des pairs 7 publications Estimé 15 000 chercheurs
Présentations de la conférence scientifique 12 présentations Estimé 3 500 participants

Plateformes de communication numérique

Métriques d'engagement en ligne:

  • Site Web de l'entreprise: 45 672 visiteurs mensuels uniques
  • LinkedIn adepte: 8 234
  • Twitter abonnés: 3 987

Canaux de soumission réglementaires

Agence de réglementation Type de soumission 2023 Soumissions
FDA Applications IND 3 soumissions
Ema Protocoles d'essais cliniques 2 soumissions

Altimmune, Inc. (ALT) - Modèle d'entreprise: segments de clientèle

Fournisseurs de soins de santé

Alticmune cible les prestataires de soins de santé spécialisés dans les maladies infectieuses et l'immunologie.

Type de fournisseur Taille du marché potentiel Cible
Cliniques de maladies infectieuses 12 500 cliniques aux États-Unis Vaccines Covid-19 et grippe
Départements d'immunologie de l'hôpital 6 200 hôpitaux à l'échelle nationale Solutions d'immunothérapie avancées

Agences de santé gouvernementales

Altimmune s'engage avec les organisations de santé fédérales et étatiques pour le développement et l'approvisionnement des vaccins.

  • Centers for Disease Control and Prevention (CDC)
  • National Institutes of Health (NIH)
  • Programmes d'approvisionnement des vaccins du ministère de la Défense (DoD)

Institutions de recherche

Les partenariats collaboratifs se concentrent sur la recherche immunologique et la technologie des vaccins.

Type d'institution Nombre de partenaires potentiels Focus de recherche
Centres de recherche universitaires 285 grandes institutions Développement
Laboratoires de recherche privés 127 installations spécialisées Innovation d'immunothérapie

Sociétés pharmaceutiques

Altimmune collabore avec les entreprises pharmaceutiques pour le développement et les licences de vaccins.

  • Top 20 des sociétés pharmaceutiques mondiales En tant que partenaires de collaboration potentiels
  • Concentrez-vous sur les technologies des vaccins respiratoires et infectieux

Populations de patients immunodéprimés

Ciblant les groupes de patients avec des vaccins spécialisés et des besoins thérapeutiques.

Groupe de patients Population estimée Besoins spécifiques
Patiens du VIH / SIDA 1,2 million aux États-Unis Formulations de vaccins spécialisés
Patients cancéreux 18,1 millions de survivants Support du système immunitaire
Transplantation d'organes 189 000 par an Interventions immunomodulatrices

Altimmune, Inc. (ALT) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice se terminant le 31 décembre 2023, Altimmune a déclaré des dépenses de R&D de 40,9 millions de dollars.

Catégorie de dépenses Montant (2023)
Total des dépenses de R&D 40,9 millions de dollars
Coûts de R&D liés au personnel 22,3 millions de dollars
Coûts de recherche externes 12,6 millions de dollars
Matériaux de laboratoire 5,9 millions de dollars

Investissements d'essais cliniques

Altimmune a alloué 18,7 millions de dollars spécifiquement pour les frais d'essai cliniques en 2023.

  • Adcovid Vaccine Clinical Trials: 7,2 millions de dollars
  • Heptcell Hepatite B Essais cliniques thérapeutiques: 6,5 millions de dollars
  • Autre développement clinique de pipeline: 5,0 millions de dollars

Maintenance de la propriété intellectuelle

Les coûts annuels de propriété intellectuelle pour AlTmune étaient d'environ 1,5 million de dollars en 2023.

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire ont totalisé 3,2 millions de dollars pour l'exercice 2023.

Recrutement du personnel et des talents scientifiques

Catégorie de dépenses du personnel Montant (2023)
Total des dépenses du personnel 32,6 millions de dollars
Rémunération des dirigeants 8,9 millions de dollars
Salaires du personnel scientifique 15,7 millions de dollars
Recrutement et formation 2,4 millions de dollars

Structure totale des coûts opérationnels pour 2023: 96,5 millions de dollars


Altimmune, Inc. (ALT) - Modèle d'entreprise: sources de revenus

Accords potentiels de licence de vaccination

Depuis le quatrième trimestre 2023, Altimmune possède des opportunités de revenus de licence potentielles pour son portefeuille de vaccins, en particulier:

Candidat au vaccin Valeur de licence potentielle Marché cible
Adcov Potentiel de licence initial de 25 à 50 millions de dollars Marché Covid-19
Nasovax Valeur de licence potentielle de 15 à 35 millions de dollars Prévention de la grippe

Subventions de recherche gouvernementale

Altimmune a reçu le financement de la recherche gouvernementale comme suit:

  • Total des subventions au NIH en 2022: 4,3 millions de dollars
  • Valeur du contrat Barda: 21,4 millions de dollars
  • Financement de la recherche du ministère de la Défense: 2,7 millions de dollars

Collaborations de partenariat stratégique

Répartition actuelle des revenus de partenariat stratégique:

Partenaire Valeur de collaboration Domaine de mise au point
Partenaire pharmaceutique un 12,5 millions de dollars Développement
Institution de recherche B 3,8 millions de dollars Recherche d'immunothérapie

Future commercialisation des produits

Potentiel de revenus commerciaux projetés:

  • Taille du marché estimé à Nasovax: 450 millions de dollars par an
  • Pénétration potentielle du marché ADCOV: 280 millions de dollars
  • Valeur estimée du pipeline d'immunothérapie: 175 millions de dollars

Paiements de jalons potentiels

Structure de paiement d'étape prévue:

Catégorie d'étape Fourchette de paiement potentielle Probabilité
Réalisation préclinique 5-10 millions de dollars Haut
Succès clinique de phase I 15-25 millions de dollars Moyen
Approbation réglementaire 50-75 millions de dollars Faible

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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