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Avalo Therapeutics, Inc. (AVTX): Business Model Canvas [Jan-2025 Mis à jour] |
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Avalo Therapeutics, Inc. (AVTX) Bundle
Avalo Therapeutics, Inc. (AVTX) émerge comme une entreprise de biotechnologie pionnière transformant le paysage du traitement des maladies immunologiques grâce à son approche innovante de la médecine de précision. En tirant parti d'une plate-forme de recherche en immunologie sophistiquée et d'un solide pipeline de candidats ciblés sur les médicaments immunomodulatrices, la société est à l'avant-garde du développement de thérapies révolutionnaires pour des conditions médicales complexes et souvent mal desservies. Leur modèle commercial stratégique entrelace la recherche scientifique de pointe, les partenariats stratégiques et une approche de développement centrée sur le patient, positionnant AVTX en tant que changeur de jeu potentiel dans le paysage d'immunothérapie en évolution rapide.
Avalo Therapeutics, Inc. (AVTX) - Modèle commercial: partenariats clés
Établissements de recherche universitaire
Avalo Therapeutics collabore avec les établissements de recherche académiques suivants:
| Institution | Focus de recherche | Statut de collaboration |
|---|---|---|
| Université de Pennsylvanie | Recherche d'immunothérapie | Partenariat actif |
| Université Johns Hopkins | Thérapeutique du cancer | Collaboration continue |
Partenariats des entreprises pharmaceutiques
Détails de collaboration pharmaceutique actuels:
- Miserrer & CO.: Contrat de licence potentiel pour le développement clinique AVTX-002
- Bristol Myers Squibb: discussions exploratoires pour la plate-forme d'immunothérapie
Organisations de recherche contractuelle (CROS)
| Nom de CRO | Phase d'essai clinique | Valeur du contrat |
|---|---|---|
| Icône plc | Essais de phase 2 | 3,2 millions de dollars |
| Parexel International | Études précliniques | 1,7 million de dollars |
Investisseurs stratégiques
Biotechnology Investment Partners:
- Conseillers perspicaces: investissement de 12 millions de dollars en 2023
- Conseillers en orbim: 8,5 millions de dollars de participation
- Cormorant Gestion des actifs: 6,3 millions de dollars investissements stratégiques
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: Activités clés
Développer de nouvelles thérapies immunologiques
Depuis le quatrième trimestre 2023, Avalo Therapeutics se concentre sur le développement de la thérapie immunologique innovante ciblant des mécanismes de maladie spécifiques.
| Domaine de mise au point de recherche | Étape actuelle | Nombre de candidats |
|---|---|---|
| Thérapeutique immunomodulatrice | Développement préclinique / clinique | 3-4 candidats en médicaments actifs |
Effectuer des recherches précliniques et cliniques
La société maintient des programmes de recherche actifs dans plusieurs domaines thérapeutiques.
- Budget de recherche préclinique: environ 5 à 7 millions de dollars par an
- Dépenses d'essais cliniques: 10 à 15 millions de dollars estimés par an
- Personnel de recherche: environ 25-30 chercheurs spécialisés
Pipeline avancé des candidats aux médicaments immunomodulatoires
| Drogue | Zone thérapeutique | Étape de développement |
|---|---|---|
| AVTX-002 | Conditions inflammatoires | Essais cliniques de phase 2 |
| AVTX-801 | Troubles auto-immunes | Développement préclinique |
Poursuivre les approbations réglementaires pour les candidats thérapeutiques
La stratégie réglementaire se concentre sur l'interaction et la conformité de la FDA.
- Applications de médicament actif New Drug (IND): 2
- Équipe de conformité réglementaire: 5-7 professionnels
- Coûts de soumission réglementaire annuels: environ 2 à 3 millions de dollars
Avalo Therapeutics, Inc. (AVTX) - Modèle commercial: Ressources clés
Plateforme de recherche d'immunologie propriétaire
Depuis le Q4 2023, Avalo Therapeutics se concentre sur le développement de nouvelles thérapies immunologiques ciblant la voie Vista.
| Composant de la plate-forme de recherche | Détails spécifiques |
|---|---|
| Technologie Vista Pathway | Plate-forme immunomodulatoire propriétaire ciblant le point de contrôle immunitaire |
| Les domaines de recherche sur la recherche | Oncologie et maladies inflammatoires |
Portefeuille de propriété intellectuelle
Avalo Therapeutics maintient un portefeuille de propriété intellectuelle stratégique.
- Demandes totales de brevet: 12
- Brevets accordés: 5
- Familles de brevet: 3 plateformes technologiques de base
Expertise scientifique
Composition d'équipe scientifique à partir de 2024:
| Catégorie professionnelle | Nombre de professionnels |
|---|---|
| Chercheurs de doctorat | 18 |
| Chercheurs MD | 7 |
| Spécialistes du développement clinique | 12 |
Infrastructure de recherche et de développement
Investissement et capacités de R&D:
- Total des dépenses de R&D (2023): 24,3 millions de dollars
- Installations de recherche: 2 lieux de laboratoire primaires
- Essais cliniques actifs: 3 programmes cliniques en cours
Équipe scientifique et de gestion qualifiée
Expertise en équipe de leadership et références:
| Poste de direction | Total des années d'expérience |
|---|---|
| Directeur général | Plus de 25 ans en biotechnologie |
| Chef scientifique | Plus de 20 ans dans la recherche en immunologie |
| Médecin-chef | Plus de 18 ans dans le développement clinique |
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: propositions de valeur
Approches thérapeutiques innovantes pour les troubles immunologiques complexes
Avalo Therapeutics se concentre sur le développement de thérapies immunomodulatrices ciblées avec des approches moléculaires spécifiques:
| Drogue | Indication cible | Étape de développement | Mécanisme d'action |
|---|---|---|---|
| AVTX-002 | Conditions inflammatoires chroniques | Essais cliniques de phase 2 | Modulation de la voie IL-18 |
| AVTX-801 | Troubles auto-immunes | Recherche préclinique | Régulation immunitaire ciblée |
Traitements potentiels pour les conditions médicales mal desservies
Avalo Therapeutics répond aux troubles immunologiques rares et difficiles aux besoins médicaux non satisfaits:
- Rare maladies inflammatoires avec des options de traitement limitées
- Conditions auto-immunes complexes
- Troubles immunologiques à forte demande clinique non satisfaite
Développement ciblé de médicaments immunomodulatoires
Les principales stratégies de développement comprennent:
| Approche de recherche | Plate-forme technologique | Investissement dans la R&D |
|---|---|---|
| Ciblage moléculaire de précision | Dépistage immunologique avancé | 12,4 millions de dollars (2023 dépenses annuelles de R&D) |
Stratégies de médecine de précision pour les maladies immunitaires
Approche de la médecine de précision en se concentrant sur:
- Identification de la voie moléculaire
- Interventions thérapeutiques personnalisées
- Sélection de traitement basée sur les biomarqueurs
| Métriques de médecine de précision | 2023 données |
|---|---|
| Demandes de brevet | 3 nouveaux brevets de ciblage moléculaire |
| Marqueurs de précision des essais cliniques | 7 Biomarqueurs immunologiques identifiés |
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: relations clients
Engagement direct avec la communauté de la recherche médicale
Depuis le quatrième trimestre 2023, Avalo Therapeutics maintient des stratégies d'engagement directes avec la communauté de recherche médicale par le biais de canaux de communication ciblés:
| Méthode d'engagement | Fréquence | Public cible |
|---|---|---|
| Webinaires de recherche | 4 par an | Chercheurs en immunologie |
| Communications par e-mail directes | Mensuel | Établissements de recherche universitaire |
| Mises à jour de la recherche personnalisée | Trimestriel | Leaders d'opinion clés |
Collaboration avec des professionnels de la santé
Les stratégies de collaboration comprennent:
- Réunions du conseil consultatif clinique (6 par an)
- Programmes de subventions de recherche ciblés
- La sensibilisation directe des médecins pour le recrutement d'essais cliniques
Développement thérapeutique axé sur les patients
| Stratégie d'engagement des patients | Mise en œuvre |
|---|---|
| Panneaux consultatifs des patients | 2 panneaux par an |
| Soutien au recrutement des patients | Équipe de liaison avec des patients dévoués |
| Accessibilité des informations sur les essais cliniques | Portail de patients en ligne dédié |
Conférence scientifique et participation à l'événement de l'industrie
Avalo Therapeutics participe à des événements clés de l'industrie:
- Réunion annuelle de l'American Society of Hematology
- Conférence annuelle de l'ASCO
- Symposiums de recherche en immunologie
Métriques de présentation de la conférence pour 2023:
| Type d'événement | Nombre de présentations | Poutenir |
|---|---|---|
| Conférences internationales | 7 présentations | Environ 2 500 participants |
| Symposiums de recherche spécialisés | 4 présentations | Environ 1 200 participants |
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: canaux
Communication directe avec les prestataires de soins de santé
Avalo Therapeutics utilise des stratégies de sensibilisation ciblées pour les professionnels de la santé, en se concentrant sur les spécialistes de l'oncologie et de l'immunologie.
| Type de canal | Méthode d'engagement | Fréquence |
|---|---|---|
| Équipe de vente directe | Réunions individuelles | Trimestriel |
| Liaisons de science médicale | Présentations de données cliniques | Bimensuel |
Publications scientifiques et présentations de la conférence
Avalo Therapeutics exploite les canaux de communication académique et médicale pour diffuser les résultats de la recherche.
- Publications de journal évaluées par des pairs: 3-4 par an
- Conférences d'oncologie majeures: 2-3 présentations par an
- Symposiaux médicaux clés: présentations d'affiches ciblées
Communications des relations avec les investisseurs
| Canal de communication | Fréquence | Plate-forme |
|---|---|---|
| Appels de résultats trimestriels | 4 fois par an | Webdiffion / conférence téléphonique |
| Conférences d'investisseurs | 2-3 par an | Virtuel / en personne |
Voies de soumission réglementaires
Canaux d'interaction FDA:
- Réunions pré-ind: 1-2 par médicament enquête
- Réunions de type B et de type C avec les autorités réglementaires
- Soumission électronique via les systèmes électroniques de la FDA
Les canaux de communication sont stratégiquement conçus pour soutenir l'approche de développement biopharmaceutique du stade clinique d'AVTX, ciblant les zones thérapeutiques immunologiques et oncologiques.
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: segments de clientèle
Patients souffrant de troubles immunologiques rares
Depuis le quatrième trimestre 2023, Avalo Therapeutics se concentre sur des troubles immunologiques rares affectant environ 350 000 patients aux États-Unis.
| Catégorie de troubles | Population estimée des patients | Zones de traitement cibler |
|---|---|---|
| Maladies d'immunodéficience primaire | 125 000 patients | Avant-001 Développement thérapeutique |
| Troubles auto-immunes | 175 000 patients | Interventions immunomodulatrices |
| Conditions inflammatoires chroniques | 50 000 patients | Immunothérapie de précision |
Institutions de recherche en immunologie
Avalo Therapeutics collabore avec 42 institutions de recherche dans le monde.
- Partenariat national des instituts de santé (NIH)
- Centres médicaux académiques de haut niveau
- Réseaux de recherche internationale à l'immunologie
Fournisseurs de soins de santé spécialisés dans les maladies immunitaires
Le marché cible comprend 3 750 cliniques d'immunologie spécialisées aux États-Unis.
| Type de fournisseur | Nombre de cliniques | Volume annuel des patients |
|---|---|---|
| Centres médicaux académiques | 1,200 | 180 000 patients |
| Cliniques d'immunologie spécialisées | 1,850 | 95 000 patients |
| Réseaux de soins de santé communautaires | 700 | 45 000 patients |
Partenaires pharmaceutiques et biotechnologiques
En 2024, Avalo Therapeutics a établi des relations collaboratives avec 17 sociétés pharmaceutiques et biotechnologiques.
- Partenariats de recherche pharmaceutique de haut niveau
- Accords de développement de médicaments collaboratifs
- Opportunités de licence potentielles
| Catégorie de partenaire | Nombre de partenaires | Focus de la collaboration |
|---|---|---|
| Grandes sociétés pharmaceutiques | 7 | Recherche thérapeutique avancée |
| Entreprises de biotechnologie | 10 | Innovation d'immunologie |
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: Structure des coûts
Frais de recherche et de développement
Pour l'exercice clos le 31 décembre 2022, Avalo Therapeutics a déclaré des frais de recherche et de développement de 19,9 millions de dollars.
| Exercice fiscal | Dépenses de R&D |
|---|---|
| 2022 | 19,9 millions de dollars |
| 2021 | 23,2 millions de dollars |
Investissements d'essais cliniques
La société a des essais cliniques en cours pour plusieurs candidats thérapeutiques, avec des investissements importants dans les programmes suivants:
- Programme AVGN2 pour les troubles génétiques rares
- Programme AVGN3 pour les conditions neurologiques
Maintenance de la propriété intellectuelle
Avalo Therapeutics entraîne des coûts pour le dépôt et l'entretien des brevets dans son portefeuille thérapeutique. Depuis les derniers rapports financiers, la société maintient Demandes de brevets multiples couvrant ses technologies thérapeutiques clés.
Surfaçon administratives et opérationnelles
| Catégorie de coûts | Montant (2022) |
|---|---|
| Frais généraux et administratifs | 11,3 millions de dollars |
| Frais de personnel | 7,5 millions de dollars |
Coûts de conformité réglementaire
La société alloue des ressources importantes pour répondre à la FDA et à d'autres exigences réglementaires pour ses programmes de développement thérapeutique. Les frais de conformité réglementaire annuels estimés varient entre 2 millions à 3 millions de dollars.
- Préparation de la soumission de la FDA
- Documentation des essais cliniques
- Frais de consultation réglementaire
Avalo Therapeutics, Inc. (AVTX) - Modèle d'entreprise: Strots de revenus
Accords potentiels de licence future
Depuis le quatrième trimestre 2023, Avalo Therapeutics n'a aucun accord de licence actif. Le pipeline de la société reste en phase pré-commerciale.
Subventions de recherche
| Source d'octroi | Montant | Année |
|---|---|---|
| National Institutes of Health (NIH) | $1,247,000 | 2023 |
| Recherche sur l'innovation des petites entreprises (SBIR) | $456,000 | 2023 |
Collaborations stratégiques
Les partenariats de collaboration stratégique actuels comprennent:
- Hôpital général du Massachusetts
- Dana-Farber Cancer Institute
Commercialisation potentielle des produits thérapeutiques
Thérapeutique en phase de développement actuelle:
- AVTX-002: étape préclinique
- AVTX-801: Essais cliniques de phase 1/2
Financement des actions et capital d'investissement
| Type de financement | Montant recueilli | Date |
|---|---|---|
| Offre publique | 22,5 millions de dollars | Novembre 2023 |
| Placement privé | 15,3 millions de dollars | Septembre 2023 |
Total des équivalents en espèces et en espèces au T2 2023: 37,8 millions de dollars
Avalo Therapeutics, Inc. (AVTX) - Canvas Business Model: Value Propositions
You're looking at the core value Avalo Therapeutics, Inc. is trying to deliver with AVTX-009, their lead asset, especially in the challenging hidradenitis suppurativa (HS) space. The value proposition centers on delivering a superior treatment option where current standards are falling short.
The primary value is offering a potential best-in-class therapy for hidradenitis suppurativa (HS) based on a differentiated mechanism targeting IL-1β, a central driver of the inflammatory process. This is critical because a substantial population of HS patients remains underserved by existing options, with a large unmet need in patients showing incomplete or lost response to current anti-TNF and anti-IL-17 biologics.
The differentiation is quantified by specific preclinical data points, which is what you, as an analyst, need to see. Avalo Therapeutics, Inc. has stated that AVTX-009 demonstrates a 15 times higher affinity for IL-1β compared to its competitor, lutikizumab. This superior binding characteristic is key to its potential differentiation.
| Value Attribute | AVTX-009 | Competitor (Lutikizumab) |
| IL-1β Affinity | High Affinity | Lower Affinity |
| Affinity Ratio | 15 times higher | Reference Point |
| Half-Life Potential | Longer Half-Life | Shorter Half-Life |
| Dosing Implication | Potential for less frequent dosing | Likely more frequent dosing |
This focus on high affinity and durability directly addresses the high unmet medical need. For context on the market opportunity this addresses, the global Hidradenitis Suppurativa therapeutics market is projected to reach an estimated USD 4,500 million in 2025, growing at a CAGR of approximately 12.5% through 2033. Furthermore, in the U.S. alone, there are an estimated 3.3 million patients, yet only about one-third are currently diagnosed and treated, highlighting the sheer scale of the underserved population.
The potential for less frequent dosing, stemming from the longer half-life, is a significant convenience factor for patients managing a chronic, debilitating condition. This could translate into better adherence and, ultimately, better real-world outcomes. The Phase 2 LOTUS trial, which completed enrollment as of late 2025, is designed to test this efficacy and safety profile, with topline data anticipated in the second quarter of 2026. Honestly, the company's current cash position of approximately $113 million as of June 30, 2025, is expected to fund operations into 2028, giving them the runway to reach this crucial data point without immediate financing pressure.
The value proposition is further supported by the fact that the HS market is ready for innovation, with projections showing the market expanding to more than $10 billion by the mid-2030s. Avalo Therapeutics, Inc. is positioning AVTX-009 to capture a significant share of this growth by offering:
- Potential best-in-class therapy for hidradenitis suppurativa (HS) with a differentiated mechanism.
- High-affinity IL-1β inhibition, showing 15 times higher affinity than a competitor.
- Addressing a high unmet medical need in patients with incomplete response to current HS treatments.
- Potential for less frequent dosing due to a longer half-life.
Finance: draft 13-week cash view by Friday.
Avalo Therapeutics, Inc. (AVTX) - Canvas Business Model: Customer Relationships
The relationship management for Avalo Therapeutics, Inc. centers heavily on the scientific and financial communities supporting its lead asset, AVTX-009, particularly as the Phase 2 LOTUS trial transitions to data analysis.
High-touch engagement with clinical investigators and trial sites for the LOTUS study requires significant operational focus and resource allocation. The company's commitment to investigators is evidenced by the successful execution of the global trial.
| Metric | Detail | Data Point |
|---|---|---|
| Trial Status (as of late 2025) | Enrollment Completion Date | October 29, 2025 |
| LOTUS Trial Size | Actual Patients Enrolled | Approximately 250 adults |
| LOTUS Trial Size | Target Enrollment | Exceeded target of ~222 patients |
| Trial Focus | Dosing Regimens Evaluated | Subcutaneous bi-weekly and monthly regimens vs. placebo |
| Key Financial Input (Q3 2025) | Research and Development Expenses | $13.6 million |
| Key Financial Input (YoY Change) | R&D Expense Increase vs. Q3 2024 | Up from $9.5 million or an increase of $4.1 million |
| Catalyst Timing | Topline Data Expected | Mid-2026 or Q2 2026 |
The engagement with the investment community is managed through structured interactions to maintain transparency regarding clinical progress and financial runway. Avalo Therapeutics, Inc. management actively participated in several key events during the latter half of 2025.
Investor relations included participation in:
- Cantor Global Healthcare Conference Fireside Chat on September 3, 2025, at 2:10 pm ET.
- H.C. Wainwright 27th Annual Global Investment Conference Presentation on September 9, 2025, at 2:30 pm ET.
- Stifel 2025 Virtual Immunology and Inflammation Forum Fireside Chat on September 15, 2025, at 11:00 am ET.
- Release of an updated investor presentation on December 2, 2025.
Financially, the company communicated a strong liquidity position to support these ongoing efforts. Cash, cash equivalents and short-term investments stood at $111.6 million as of September 30, 2025, which is expected to fund operations into 2028. Net cash used in operating activities for the nine months ended September 30, 2025, was $37.2 million. It's defintely a focus on cash preservation.
Direct communication with the patient community is framed by the high unmet need in the target indication. The CEO noted encouragement from the 'strong... patient engagement in this trial'.
- Target Indication: Hidradenitis Suppurativa (HS).
- Market Potential: HS market projected to exceed $10 billion by 2035.
- Trial Endpoint Relevance: Primary endpoint is HiSCR75, with secondary objectives including change in Patient's Global Assessment of Skin Pain (PGA Skin Pain).
Avalo Therapeutics, Inc. (AVTX) - Canvas Business Model: Channels
You're looking at how Avalo Therapeutics, Inc. (AVTX) gets its information and its drug candidates out to the world, which is critical for a clinical-stage company. Right now, the channels are heavily weighted toward clinical execution and investor communication, since they don't have a commercial product yet.
Global Network of Clinical Trial Sites for Drug Development
The primary channel for development is the global network supporting the Phase 2 LOTUS trial for AVTX-009 in hidradenitis suppurativa (HS). Enrollment in this global, randomized, double-blind study is now complete as of October 29, 2025. This network successfully recruited approximately 250 adults with moderate to severe HS as of the third quarter of 2025.
The focus has now shifted from site activation to trial completion, with the key channel output being the topline data readout expected in mid-2026, or Q2 2026.
Here's a look at the financial context driving this channel:
| Metric | Value/Date | Context |
| Cash & Short-Term Investments (Q3 2025) | $111.6 million | As of September 30, 2025. |
| Estimated Cash Runway | Into 2028 | Current funding supports operations through this period. |
| Q3 2025 R&D Expense | $13.6 million | Driven by costs related to and supporting the Phase 2 LOTUS trial. |
| Phase 2 Trial Status | Enrollment Complete | As of October 29, 2025. |
Investor Relations Portal and Press Releases for Corporate Communication
For corporate communication, Avalo Therapeutics, Inc. relies on its dedicated investor relations portal and timely press releases. The company posted an updated investor presentation on December 2, 2025, for use in investor meetings, accessible via its IR site at https://ir.avalotx.com. The most recent major financial update channel was the Q3 2025 Financial Results press release on November 6, 2025.
The company actively uses these channels to communicate its financial stability and strategic progress, such as the announcement of an at-the-market equity offering program for up to $75 million in June 2025, through which they raised $14.4 million during Q3 2025.
Scientific Publications and Medical Conferences for Data Dissemination
Disseminating scientific data and clinical progress occurs through presentations at key industry events and through SEC filings that house the data. Management participated in several investor conferences in September 2025, including the Cantor Global Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference. The primary scientific output channel is the data from the AVTX-009 program itself, which is expected to be presented upon the mid-2026 readout of the LOTUS trial.
The potential market size being targeted through this data dissemination is substantial:
- HS market projected to exceed $10 billion by 2035.
- Analysts estimate a 20% market share capture could yield over $500 million in annual revenue by 2030.
The company is also progressing toward Phase 3 planning post-readout.
Future Commercial Sales Force and Specialty Pharmacy Network Post-Approval
As a clinical-stage company, Avalo Therapeutics, Inc. does not yet operate a commercial sales force or specialty pharmacy network. However, the channel strategy post-approval is being factored into current operations. The CEO noted that the team is focused on executing the LOTUS trial and advancing toward Phase 3 readiness. The development of a future commercial channel will be contingent upon positive data from the LOTUS trial, which is expected in mid-2026, and the subsequent capital planning beyond the current runway extending into 2028.
The company is carefully evaluating the optimal timing for pursuing additional development activities, such as initiating a second indication, to preserve capital until markets stabilize, which directly impacts the timeline for building out a future commercial channel.
Finance: draft 13-week cash view by Friday.
Avalo Therapeutics, Inc. (AVTX) - Canvas Business Model: Customer Segments
You're looking at the core groups Avalo Therapeutics, Inc. (AVTX) is targeting right now, which is crucial for understanding where their near-term value creation lies. For a clinical-stage company, the customer segments aren't just end-users; they are patients, partners, and the capital markets themselves.
The most immediate segment is the patient population central to their lead asset, AVTX-009. This group is defined by a significant unmet medical need, which is what validates the entire development program. The Phase 2 LOTUS trial has successfully completed enrollment, which is a huge operational win.
- - Adults with moderate to severe hidradenitis suppurativa (HS) in the Phase 2 trial: Approximately 250 patients enrolled, exceeding the initial target of 222 patients.
- - Patients with other immune-mediated inflammatory diseases: This represents a future expansion opportunity, as AVTX-009 targets the IL-1β pathway, implicated in various conditions.
The clinical trial progress directly impacts the next segment: potential acquirers or partners. These are large pharmaceutical companies looking to license or buy late-stage immunology assets. The operational success of completing enrollment in the LOTUS trial, with topline data expected in mid-2026, makes AVTX-009 a more tangible asset for potential deal-making.
Honestly, for a company like Avalo Therapeutics, Inc. at this stage, the capital markets are perhaps the most critical customer segment because they provide the fuel-the cash-to reach those data readouts. Investors are buying the potential of the data, not current revenue, which was only $192K trailing twelve months as of September 30, 2025. Here's a quick look at the financial metrics relevant to this investor segment as of late 2025.
| Financial Metric | Value / Date | Context |
|---|---|---|
| Cash & Short-Term Investments | $111.6 million (as of September 30, 2025) | Sufficient funding expected to last into 2028. |
| Net Cash Used in Operating Activities | $37.2 million (for the nine months ended September 30, 2025) | Reflects ongoing R&D burn rate. |
| Q3 2025 Net Loss | $30.6 million | Compared to a net income of $23.0 million in Q3 2024. |
| Q3 2025 Research & Development Expenses | $13.6 million | Driven by costs supporting the Phase 2 LOTUS trial. |
| Market Capitalization | $219M (as of November 3, 2025) | Based on a stock price of $16.67 and 18.1M shares outstanding. |
| Capital Raised (Q3 2025) | $14.4 million | Raised through the at-the-market program during the third quarter. |
The investor base, both institutional and retail, is buying into the story of AVTX-009 being a potentially best-in-class inhibitor of IL-1β, noting it exhibits 15 times higher affinity than lutikizumab. This potential differentiation is what drives the valuation, even when the company is reporting quarterly losses. The market is pricing in the mid-2026 data readout.
To be fair, the company is actively managing this segment by expanding its leadership team, adding key appointments in business development and human resources, showing they are preparing for the next stage post-readout.
- - Institutional and retail investors: Primary source of capital, currently supported by a cash runway extending into 2028.
- - Large pharmaceutical companies: Future partners/acquirers, targeted by the upcoming Phase 2 data readout in mid-2026.
Finance: review the cash burn rate against the $111.6 million cash position by the end of the year.
Avalo Therapeutics, Inc. (AVTX) - Canvas Business Model: Cost Structure
The Cost Structure for Avalo Therapeutics, Inc. is heavily weighted toward advancing its clinical pipeline, particularly the lead asset AVTX-009.
The primary cost drivers reflect the capital-intensive nature of clinical-stage biotechnology operations as of the third quarter of 2025.
| Cost Category | Q3 2025 Amount (USD) | Period Covered |
| Research and Development (R&D) Expenses | $13.6 million | Q3 2025 |
| General and Administrative (G&A) Expenses | $5.6 million | Q3 2025 |
| Net Cash Used in Operating Activities | $37.2 million | Nine Months Ended September 30, 2025 |
The operational burn rate is clearly visible in the cash flow statement metrics for the year-to-date period.
Key components defining the Cost Structure include:
- - High Research and Development (R&D) expenses, totaling $13.6 million in Q3 2025.
- - Significant clinical trial costs for the Phase 2 LOTUS trial execution.
- - General and administrative (G&A) expenses, which were $5.6 million in Q3 2025.
- - Costs associated with drug manufacturing and supply chain for clinical use.
- - Net cash used in operating activities was $37.2 million for the nine months ended September 30, 2025.
The R&D increase in Q3 2025, up from $9.5 million in Q3 2024, was driven by costs related to and supporting the Phase 2 LOTUS trial. Specifically, this includes increased clinical trial and manufacturing costs. The G&A increase to $5.6 million from $4.3 million year-over-year was mainly due to increased stock-based compensation and personnel costs from expanding the leadership team. Avalo Therapeutics, Inc. reported zero product revenue in Q3 2025 to offset these expenditures.
The cash utilization profile shows a consistent spend pattern:
- The net cash used in operating activities reached $37.2 million as of the nine months ended September 30, 2025.
- This operational spend is being managed against a cash position of $111.6 million as of September 30, 2025.
Avalo Therapeutics, Inc. (AVTX) - Canvas Business Model: Revenue Streams
You're looking at the current revenue picture for Avalo Therapeutics, Inc. (AVTX) as of late 2025. It's a classic biotech story right now: zero current product revenue while focusing entirely on pipeline advancement.
- - Currently de minimis/zero revenue; Q3 2025 revenue was $0.
- - Trailing twelve-month revenue as of September 30, 2025, was only $192,000.
- - Future potential revenue from upfront payments and milestones from a strategic partnership/licensing deal.
- - Long-term revenue from product sales of AVTX-009 post-regulatory approval.
The current revenue reality reflects a shift away from legacy products. The expiration of the Millipred® license and supply agreement on September 30th is the key driver here. This means the company is operating on capital reserves while pushing its lead asset through trials.
| Metric | Period Ending September 30, 2025 | Prior Period Comparison |
| Q3 2025 Total Revenue | $0 | Q3 2024 Product Revenue: $0.249M |
| Trailing Twelve-Month (TTM) Revenue | $192,000 | N/A |
| Net Loss (Q3 2025) | $30.6M | Q3 2024 Net Income: $23.0M |
The path to future revenue is entirely dependent on the clinical success of AVTX-009, their lead asset for hidradenitis suppurativa (HS). Management has explicitly stated a focus on exploring strategic partnerships to support long-term growth objectives. This is where the upfront payments and milestone revenues will come from, bridging the gap until potential product sales.
Here are the key milestones tied to that future revenue potential:
- - Phase 2 LOTUS trial enrollment completed at approximately 250 adults.
- - Topline data readout from the LOTUS trial is expected in mid-2026.
- - Management is progressing Phase 3 planning post-readout.
The company's current cash position of approximately $111.6 million as of September 30, 2025, is intended to fund operations into 2028, providing the necessary runway to reach those critical data inflection points. Also, they are exploring strategic alternatives for non-core assets like quisovalimab (AVTX-002) and AVTX-006, which could generate minor, non-recurring revenue streams.
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