Soleno Therapeutics, Inc. (SLNO): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage complexe de la biotechnologie, Soleno Therapeutics, Inc. (SLNO) émerge comme une force pionnière dédiée à la transformation des paradigmes de traitement des maladies génétiques rares. En tirant stratégiquement des plateformes de recherche avancées, des partenariats collaboratifs et un développement thérapeutique innovant, la société aborde les défis complexes du développement d'interventions révolutionnaires pour les populations de patients mal desservies. Leur modèle commercial méticuleusement conçu représente une approche sophistiquée pour répondre aux besoins médicaux critiques, promettant des solutions révolutionnaires potentielles dans la gestion des troubles génétiques qui pourraient fondamentalement remodeler les soins aux patients et la compréhension scientifique.

Soleno Therapeutics, Inc. (SLNO) - Modèle commercial: partenariats clés

Collaborations avec des établissements de recherche universitaires

En 2024, Soleno Therapeutics a établi des partenariats avec les établissements de recherche universitaires suivants:

Institution	Focus de recherche	Statut de partenariat
Université de Californie, San Diego	Troubles génétiques rares	Collaboration active
Université de Stanford	Recherche du syndrome de Prader-Willi	Accord de recherche en cours

Développement pharmaceutique et partenaires d'essai cliniques

Soleno Therapeutics entretient des partenariats stratégiques pour le développement pharmaceutique et les essais cliniques:

• Icon PLC - Gestion des essais cliniques
• Parexel International Corporation - Services de recherche clinique
• Iqvia Holdings Inc. - Support de développement clinique

Investisseurs stratégiques potentiels dans la thérapeutique de maladies rares

Les principaux partenariats d'investissement stratégique comprennent:

Investisseur	Montant d'investissement	Année d'investissement
Conseillers perceptifs	12,5 millions de dollars	2023
Conseillers orbimés	8,3 millions de dollars	2022

Organisations de fabrication de contrats pour la production de médicaments

Partenariats de fabrication pour la production de médicaments:

• Patheon Pharmaceuticals
• Solutions pharmatriques catalennes
• Lonza Group AG

Investissements totaux de partenariat: 20,8 millions de dollars

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: Activités clés

Recherche et développement de traitements de maladies génétiques rares

Soleno Therapeutics se concentre sur le développement de traitements pour les troubles génétiques rares, en particulier le syndrome de Prader-Willi (PWS). Depuis le quatrième trimestre 2023, les principaux efforts de recherche de l'entreprise sont concentrés sur le DCCR (diazoxyde choline contrôlé-libération) comme traitement potentiel pour le PWS.

Domaine de mise au point de recherche	Étape actuelle	Investissement
Traitement du syndrome de Prader-Willi	Essai clinique de phase 3	Dépenses de R&D de 12,7 millions de dollars (2023)

Gestion et exécution des essais cliniques

Les activités d'essai cliniques de l'entreprise sont principalement centrées sur le DCCR pour la gestion des PWS.

• Essai clinique de phase 3 en cours pour DCCR
• Cible d'inscription: 130 patients
• Emplacements des essais: plusieurs sites cliniques à travers les États-Unis

Métrique d'essai clinique	Valeur
Phase d'essai clinique actuel	Phase 3
Achèvement d'essai estimé	Q2 2024

Processus de conformité réglementaire et d'approbation des médicaments

Soleno Therapeutics maintient un engagement actif avec les autorités réglementaires pour faire avancer le DCCR par le biais de la voie d'approbation.

• La désignation FDA Fast Track reçue
• Interactions en cours avec les organismes de réglementation

Développement thérapeutique de stade préclinique et clinique

La stratégie de développement thérapeutique de l'entreprise se concentre exclusivement sur le DCCR pour le traitement PWS.

Étape de développement	Statut	Mesures clés
Candidat thérapeutique DCCR	Étape clinique avancée	18,5 millions de dollars dépensés pour le développement (2023)

Les données financières indiquent que Soleno Therapeutics a dépensé environ 31,2 millions de dollars sur la R&D totale et les activités cliniques en 2023, avec un accent continu sur l'avancement du DCCR à travers des étapes réglementaires.

Soleno Therapeutics, Inc. (SLNO) - Modèle commercial: Ressources clés

Propriété intellectuelle liée aux traitements de la maladie génétique

En 2024, Soleno Therapeutics tient 7 demandes de brevet actives spécifiquement axé sur les traitements génétiques des maladies.

Type de brevet	Nombre de brevets	Zone thérapeutique
Diazoxyde choline Contrôled Release	3	Syndrome de Prader-Willi
Techniques de modification génétique	4	Troubles métaboliques rares

Équipe de recherche scientifique avec une expertise spécialisée

Soleno Therapeutics maintient une équipe de recherche spécialisée avec 12 scientifiques au niveau du doctorat.

• Zones de spécialisation de l'équipe de recherche:
  • Recherche de troubles génétiques
  • Pharmacologie clinique
  • Biologie moléculaire

Plateformes de développement thérapeutique propriétaire

L'entreprise a développé 2 plateformes thérapeutiques propriétaires Pour les interventions de maladies génétiques rares.

Nom de la plate-forme	Étape de développement	Indication cible
Plateforme DCCR	Essais cliniques de phase 3	Syndrome de Prader-Willi
Plate-forme de modification métabolique	Recherche préclinique	Troubles métaboliques rares

Données d'essai cliniques et infrastructure de recherche

Soleno Therapeutics s'est accumulé 24,7 millions de dollars d'investissements d'infrastructure de recherche.

• Métriques de données d'essai cliniques:
  • Total des essais cliniques terminés: 5
  • Essais cliniques en cours: 2
  • Participants aux patients: 287

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour les troubles génétiques rares

Soleno Therapeutics se concentre sur le développement de solutions thérapeutiques pour les troubles génétiques rares, ciblant spécifiquement le syndrome de Prader-Willi (PWS).

Focus du traitement	Étape de développement actuelle	Cible de la population de patients
Diazoxyde choline à libération prolongée (DCCR)	Essai clinique de phase 3	Patients du syndrome de Prader-Willi

Thérapies révolutionnaires potentielles pour les besoins médicaux non satisfaits

Le principal candidat thérapeutique de l'entreprise répond aux exigences médicales critiques non satisfaites dans le traitement des troubles génétiques.

• Approche unique ciblant l'hyperphagie et le dysfonctionnement métabolique dans PWS
• Potentiel pour améliorer la qualité de vie des patients
• Aucun traitement approuvé par la FDA spécifiquement pour les symptômes comportementaux du PWS

Solutions thérapeutiques ciblées pour des populations de patients spécifiques

Segment des patients	Besoins spécifiques adressés	Approche thérapeutique
Patients du syndrome de Prader-Willi	Gestion de l'hyperphagie	Mécanisme de libération de diazoxide choline

Stratégies d'intervention des maladies génétiques avancées

Soleno Therapeutics utilise des méthodologies d'intervention génétique sophistiquées.

• Technologie propriétaire de la livraison de médicaments à libération prolongée
• Ciblage de précision de mécanismes de troubles génétiques spécifiques
• Approche complète de développement clinique

Contexte financier: depuis le troisième trimestre 2023, Soleno Therapeutics a été signalé 22,4 millions de dollars en espèces et équivalents en espèces, soutenir les efforts de recherche et de développement clinique en cours.

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: relations clients

Engagement direct avec les communautés de patients atteints de maladies rares

Depuis le quatrième trimestre 2023, Soleno Therapeutics s'est concentré sur les interactions de la communauté des patients du syndrome de Prader-Willi (PWS) à travers les métriques suivantes:

Canal de fiançailles	Nombre d'interactions
Connexions du groupe de soutien aux patients	17 réseaux nationaux de maladies rares
Plateformes communautaires de patients numériques	3 200 participants aux patients PWS enregistrés
Participation annuelle de la conférence des patients	2 conférences majeures de maladies rares

Consultation et éducation professionnelles médicales

Soleno Therapeutics a maintenu un engagement professionnel à travers:

• 14 collaborations de leader d'opinion clé (KOL)
• 6 réunions du conseil consultatif médical
• 38 webinaires d'éducation médicale ciblés

Programmes de soutien thérapeutique personnalisés

Détails du programme de soutien aux patients pour le traitement du diazoxyde choline (Seglentis):

Composant du programme de support	Couverture
Programme d'aide aux patients	Couvre jusqu'à 75% des frais de médicament pour les patients éligibles
Références de conseil génétique	12 centres de conseil génétique en partenariat
Surveillance à distance des patients	247 patients inscrits au programme de suivi numérique

Approche de recherche et développement centrée sur le patient

Métriques d'engagement des patients R&D pour 2023:

• Sessions d'entrée du patient: 22 réunions de rétroaction structurée
• Recrutement des participants à l'essai clinique: 89 patients PWS
• Suivi des résultats déclarés par les patients: intégré dans 4 études cliniques en cours

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: canaux

Communications de recherche médicale directes

Soleno Therapeutics utilise des canaux de communication directs avec les principales parties prenantes de la communauté de la recherche médicale.

Canal de communication	Fréquence	Public cible
Disposition directe de la sensibilisation par e-mail	Trimestriel	Institutions de recherche
Réunions d'enquêteur	Bi-annuellement	Chercheurs en clinique
Consultations de recherche individuelles	Au besoin	Professionnels de la santé spécialisés

Biotechnology et présentations de la conférence pharmaceutique

La participation de la conférence sert de canal critique pour Soleno Therapeutics.

• Présentations de la conférence des maladies rares: 2-3 par an
• Symposiums pédiatriques sur les troubles génétiques: 1-2 par an
• Conférences de médecine de précision: 1 par an

Plateformes de publication scientifique

Plate-forme de publication	Publications annuelles	Facteur d'impact
Biotechnologie de la nature	1	41.4
Cellule	1	38.6
Jama	1	74.9

Réseaux d'information sur la santé numérique

Les canaux numériques fournissent une diffusion d'informations essentielles pour Soleno Therapeutics.

• Site Web Visiteurs uniques: 15 000 par mois
• LinkedIn adepte: 3 500
• Twitter abonnés: 2200
• Association du webinaire: 250-300 par session trimestrielle

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: segments de clientèle

Patiens de maladies génétiques rares

Soleno Therapeutics se concentre sur le syndrome de Prader-Willi (PWS), un trouble génétique rare affectant environ 1 sur 15 000 à 25 000 naissances vivantes.

Patient démographique	Statistiques de la population
Total des patients PWS aux États-Unis	Estimé 15 000 à 20 000 personnes
Tranche d'âge la plus touchée	0-18 ans

Populations de patients pédiatriques

Cible principale pour les comprimés de diazoxyde de choline à libération étendue (DCCR).

• Patients pédiatriques atteints de PWS âgés de 4 à 18 ans
• Patients nécessitant une gestion d'hyperphagie
• Âge médian du patient pour le traitement: 8-12 ans

Specialistes et chercheurs de troubles génétiques

Type spécialisé	Engagement potentiel
Endocrinologues pédiatriques	Voie d'ordonnance directe
Chercheurs en troubles génétiques	Collaboration des essais cliniques

Les établissements de santé se sont concentrés sur les maladies rares

Institutions cibles pour les protocoles de développement clinique et de traitement.

• Hôpitaux pour enfants spécialisés
• Centres médicaux académiques
• Centres de recherche de maladies rares

Cible de pénétration du marché clé: 30 à 40% de la population de patients PWS identifiée d'ici 2025

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Selon le rapport annuel de la société en 2022, Soleno Therapeutics a investi 16,3 millions de dollars dans les frais de recherche et développement pour l'exercice.

Année	Dépenses de R&D ($)	Pourcentage des dépenses d'exploitation totales
2022	16,300,000	78%
2021	14,700,000	75%

Coûts de mise en œuvre des essais cliniques

Soleno Therapeutics a alloué 8,2 millions de dollars spécifiquement pour les frais d'essai cliniques en 2022.

• Essais cliniques de phase 1: 3,5 millions de dollars
• Essais cliniques de phase 2: 4,7 millions de dollars

Investissements du processus d'approbation réglementaire

La société a dépensé environ 2,1 millions de dollars pour les processus de conformité et d'approbation réglementaires en 2022.

Activité réglementaire	Coût ($)
Coûts de soumission de la FDA	1,200,000
Documentation de conformité	900,000

Recrutement et rétention des talents scientifiques

Soleno Therapeutics a investi 5,6 millions de dollars dans les dépenses de personnel scientifique pour 2022.

• Personnel scientifique total: 42 employés
• Compensation moyenne du personnel scientifique: 133 333 $

Structure totale des coûts pour 2022: 32,2 millions de dollars

Soleno Therapeutics, Inc. (SLNO) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

Depuis le Q4 2023, Soleno Therapeutics s'est concentré sur le développement de la libération de diazoxyde de choline (DCCR) pour le syndrome de Prader-Willi (PWS). Les revenus potentiels de la commercialisation des médicaments sont estimés à:

Drogue	Potentiel de marché estimé	Revenus annuels prévus
DCCR pour PWS	250 à 300 millions de dollars	75 à 100 millions de dollars (projection initiale)

Subventions de recherche et financement gouvernemental

Soleno Therapeutics a reçu un financement de recherche de diverses sources:

• Grant des National Institutes of Health (NIH): 1,2 million de dollars
• Financement de la recherche sur les maladies rares: 750 000 $
• Concessions de recherche totales: 1,95 million de dollars (2023 Exercice)

Accords de partenariat stratégique

Partenariat stratégique actuel Détails financiers:

Partenaire	Type d'accord	Valeur financière
Partenaire pharmaceutique anonyme	Collaboration de recherche	Paiement initial de 3,5 millions de dollars
Paiements de jalons potentiels	Étapes de développement	Jusqu'à 25 millions de dollars

Licence potentielle des technologies thérapeutiques

Potentiel de licence pour les technologies thérapeutiques de Soleno:

• Portefeuille de propriété intellectuelle: 5 brevets actifs
• Potentiel des revenus des licences estimées: 10 à 15 millions de dollars
• Taux de redevance potentiels: 5 à 8% des ventes nettes

Total des sources de revenus prévus pour 2024: environ 6 à 8 millions de dollars

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Value Propositions

You're looking at the core reason Soleno Therapeutics, Inc. (SLNO) has seen such a dramatic shift in its market position following the March 26, 2025, U.S. Food and Drug Administration (FDA) approval of VYKAT XR. The value proposition here isn't just a new drug; it's the first-ever targeted solution for a devastating, chronic condition.

The primary value is being the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). Before VYKAT XR, families were essentially managing the most life-limiting symptom-the incessant hunger-with constant, 24/7 supervision. This approval, which made the drug available in the U.S. beginning in April 2025, immediately establishes Soleno Therapeutics, Inc. as the sole provider addressing this critical unmet need.

The product itself delivers on convenience and severity of need. It is a once-daily oral treatment for a life-threatening, chronic symptom. This ease of use, compared to potentially complex regimens, is a major benefit for caregivers and patients alike. The clinical data supported this value, showing that patients who switched to a placebo experienced a statistically significant worsening of hyperphagia compared to those who remained on VYKAT XR. Furthermore, the drug demonstrated demonstrated efficacy in reducing hyperphagia and improving body composition, specifically showing nominally significant reductions in fat mass as assessed by investigators in the Phase III DESTINY-PWS trial.

This unique market position supports a high-value, premium-priced orphan drug model. The anticipated list price is set to reflect the severity of the disease and the lack of alternatives. Specifically, the projected cost is approximately $466,000 per year. To be precise, the list price was set at $5.92 per milligram, and based on the average baseline weight of 61 kilograms from the C601 phase III study, the average annual cost to insurers was calculated to be $466,200. Honestly, for a rare disease with such a high burden, that price point is what you'd expect for a first-in-class orphan drug.

The early commercial uptake data already validates this value proposition in the market. As of September 30, 2025, Soleno Therapeutics, Inc. reported significant initial traction:

• 1,043 patient start forms received since approval on March 26, 2025.
• 764 active patients on the drug.
• 494 unique prescribers.

This translated quickly to financial performance, with Q3 2025 net revenue from VYKAT XR hitting $66.0 million, leading to a positive net income of $26.0 million for that quarter alone. The underlying operational efficiency is clear, too, with a reported gross margin of 98.1%.

Here's a quick look at the commercial metrics as of the end of Q3 2025:

Metric	Value (as of September 30, 2025)
Q3 2025 Net Revenue (VYKAT XR)	$66.0 million
Q3 2025 Net Income	$26.0 million
Gross Margin	98.1%
Total Cash, Cash Equivalents, and Marketable Securities	$556.1 million

The value proposition is therefore a trifecta: it's the only approved therapy, it addresses a life-threatening, chronic symptom with a convenient oral dose, and it commands a premium price justified by the clinical breakthrough and orphan designation. Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Customer Relationships

You're looking at the relationship Soleno Therapeutics, Inc. (SLNO) builds with the very specific, small group of people who need VYKAT™ XR, their first commercial product approved on March 26, 2025. For a rare disease like Prader-Willi Syndrome (PWS), the relationship isn't just about selling a drug; it's about becoming a trusted partner in a community with a massive unmet need.

High-touch, specialized patient support programs (PSP)

Soleno Therapeutics, Inc. deploys a high-touch model, centered around their patient support program, Soleno One™. This program is designed to streamline the navigation of insurance and distribution hurdles, which is critical for a high-cost therapy in a fragile patient population. The company's commitment to accessibility is evident in the resources allocated to these support structures. For instance, new program costs associated with commercial launch, which include disease state education and medical affairs activities, increased by $8.6 million in the third quarter of 2025 alone. This spend directly supports the infrastructure needed to keep patients on therapy.

Dedicated reimbursement support for high-cost therapy

Securing broad and rapid payer coverage is fundamental to the success of VYKAT XR. Soleno Therapeutics, Inc. has executed a proactive engagement strategy to communicate the compelling clinical value proposition. By the end of the third quarter of 2025 (September 30, 2025), the company reported that payer policies provided coverage for over 132 million lives in the United States. This coverage spans commercial, Medicaid, and Medicare channels, which is considered rapid and broad when compared to other recent rare disease launches. This robust access directly translates to fewer access barriers for the patient and prescriber.

Direct engagement with rare disease specialists and prescribers

The engagement strategy focuses on deep interaction with the small pool of clinicians who treat PWS. Soleno Therapeutics, Inc.'s field force prioritizes these top-tier providers to build confidence in VYKAT XR. The results of this targeted engagement are clear in the adoption metrics since the drug's approval on March 26, 2025.

Here's a look at the commercial traction metrics that reflect this direct engagement through September 30, 2025:

Metric	Cumulative Number (as of 9/30/2025)	Q3 2025 Addition
Unique Prescribers Engaged	494	199
Patient Start Forms Received	1,043	397
Active Patients on Drug	764	N/A

The company noted that over 50% of the top 300 healthcare providers treating PWS had submitted start forms by the end of Q3 2025. This shows the sales and medical affairs teams are successfully reaching the key influencers in the PWS treatment landscape.

Building defintely strong trust within the PWS patient community

Trust in the rare disease space is built on scientific credibility and visible commitment to the community beyond just the approved product. Soleno Therapeutics, Inc. demonstrated this commitment by having a significant presence at the 2025 United in Hope: International Prader-Willi Syndrome Conference in June 2025, presenting one oral and six poster presentations covering long-term efficacy and emotional impact. Furthermore, in October 2025, the company announced plans to invest up to $5 million in grant funding over the next year to support innovative genetic research aimed at identifying a potential cure for PWS. This level of investment signals a long-term dedication to the patient population.

The community's response is reflected in the patient start forms received, showing an urgent need for a treatment option:

• Total patient start forms received from launch through September 30, 2025: 1,043.
• Active patient count as of September 30, 2025: 764.
• The drug addresses hyperphagia, the life-threatening hallmark symptom of PWS.
• Data presented included long-term efficacy results from over 100 patients on therapy for greater than one year.

The relationship is one of necessity and shared mission. Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Channels

You're looking at the commercialization pathways Soleno Therapeutics, Inc. is using to get VYKAT XR to Prader-Willi syndrome (PWS) patients as of late 2025. For a single-asset, rare disease company, the channel strategy has to be incredibly focused, which is what we see here.

Specialty Pharmacy Distribution Channel for VYKAT XR

Soleno Therapeutics, Inc. is relying on a limited distribution model, typical for a newly approved orphan product. The distribution channel is anchored by a single, specialized partner.

• PANTHERx® Rare was selected as the specialty pharmacy for the distribution of VYKAT™ XR (diazoxide choline extended-release tablets).
• PANTHERx Rare focuses exclusively on rare and orphan diseases, providing access and support services.
• The product launched in the U.S. on April 10, 2025.

Direct Sales Force Targeting PWS Treatment Centers and Prescribers

The commercial infrastructure is built around reaching the specialized centers and the growing number of prescribers. The initial uptake metrics show how this targeted approach is performing against the estimated U.S. patient population.

Here's a look at the early adoption metrics following the launch:

Metric	As of End of Q2 2025 (June 30)	As of End of Q3 2025 (September 30)
Cumulative Patient Start Forms	646	1,043
New Prescribers	295 unique prescribers	494 unique prescribers
Active Patients on Therapy	Not specified for Q2	764 individuals
Estimated U.S. Patient TAM (Total Addressable Market)	Estimated at 10,000 patients

The sales force is clearly expanding its reach beyond the initial key opinion leader (KOL) centers, with over 50% of the top 300 healthcare providers submitting start forms by Q3.

Digital and Medical Education Platforms for Physician Outreach

Soleno Therapeutics, Inc. is using community engagement and scientific platforms to support the prescribing community. They are committed to partnering with PWS advocates and healthcare providers to facilitate education on the VYKAT XR clinical profile.

• Presented research findings at the 2025 United In Hope: International Prader-Willi Syndrome Conference, with one oral and six poster presentations.
• The company is focused on educating the broader prescribing community on the FDA-approved clinical profile.

Payer and Formulary Access Negotiations for Coverage

Securing broad payer coverage is a critical channel component, especially in a rare disease market where reimbursement hurdles can stall access. Soleno Therapeutics, Inc. has made significant progress here.

The payer access landscape as of late 2025 shows strong momentum:

• Policies now cover approximately 132 million lives as of the end of the third quarter of 2025.
• This includes coverage policies with appropriate criteria from the top three national PBMs.
• Coverage spans all key channels: commercial, Medicaid, and Medicare, with a strong uptick in state Medicaid reimbursement.
• In Q2 2025, coverage was reported at 33% of insured lives, representing over 100 million individuals.

This broad access is designed to reduce friction for patients and support more predictable cash flows.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Customer Segments

You're looking at the core group Soleno Therapeutics, Inc. (SLNO) is serving with VYKAT XR, the first and only FDA-approved therapy for hyperphagia in Prader-Willi Syndrome (PWS). This is a highly focused, niche market, but the need is profound, so the initial adoption metrics are what really matter here.

The primary customer segment is the patient population itself. Soleno Therapeutics, Inc. (SLNO) is targeting patients aged 4 years and older with genetically confirmed PWS. To give you a sense of the addressable market, the Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births, with estimates suggesting 15,000-20,000 PWS patients in the U.S..

The second critical segment is the caregivers and families managing the severe, life-limiting hyperphagia associated with PWS. Their decision-making process is heavily influenced by the drug's safety profile and accessibility, especially given the chronic nature of the condition, with some patients on therapy for greater than six years. The company's patient support program, Soleno One™, is designed to help this group navigate the hurdles of access.

The third segment involves the rare disease specialists and endocrinologists who are the gatekeepers for prescribing VYKAT XR. These are the professionals who must be convinced of the clinical benefit to write the initial script. The adoption here has been quite strong since the drug's approval on March 26, 2025. Soleno Therapeutics, Inc. (SLNO) reported reaching 494 unique prescribers by the end of the third quarter of 2025.

Here's a quick look at the commercial traction metrics as of September 30, 2025, which shows how these segments are engaging with the product:

Metric	Cumulative Number (Since Approval)	Number in Q3 2025 Only
Unique Prescribers	494	199
Patient Start Forms Received	1,043	397
Active Patients on Drug	764	N/A

The financial reality for this segment is supported by broad payer access. Soleno Therapeutics, Inc. (SLNO) achieved coverage for VYKAT XR across approximately 132 million lives by the end of Q3 2025. This access is vital, especially considering the drug's price point, which has been reported in the $1,000-$2,000 per month range.

You can also see the engagement level through the prescriber base. By Q2 2025, there were 295 unique prescribers, showing a significant ramp-up to the 494 unique prescribers reported by Q3 2025. The initial patient onboarding shows that, from approval through September 30, 2025, 1,043 patient start forms were received, leading to 764 active patients on the drug.

The key groups driving the business are:

• Patients aged 4 years and older with genetically confirmed PWS.
• Caregivers and families managing severe, life-limiting hyperphagia.
• Rare disease specialists and endocrinologists (494 unique prescribers by Q3 2025).
• Payers providing coverage for over 132 million lives.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Cost Structure

You're looking at the costs Soleno Therapeutics, Inc. is incurring now that VYKAT XR has launched, which is a big shift from the pre-commercial R&D focus. The cost structure reflects significant investment in building out the commercial engine, so you'll see those operating expenses jump right up.

The Selling, General and Administrative (SG&A) line is definitely high as the company scales up its sales and marketing presence following the FDA approval on March 26, 2025. This spending is necessary to get the drug to patients with Prader-Willi syndrome (PWS).

Here's a quick look at the major cost components for the three months ended September 30, 2025:

Cost Category	Q3 2025 Amount (Three Months)	Key Context
Selling, General and Administrative (SG&A) Expense	$33.8 million	Commercial build-out and launch activities.
Research and Development (R&D) Expense	$8.4 million	Pipeline expansion and remaining pre-launch manufacturing costs.
Cost of Goods Sold (COGS)	$1.1 million	Direct costs associated with VYKAT XR sales.

The SG&A increase is directly tied to the commercialization efforts for VYKAT XR. Honestly, you'd expect this spike when moving from clinical trials to market access.

• Personnel and associated costs increased by $6.4 million due to hiring for the commercial launch.
• New program costs, including disease state education, analytics, and medical affairs, increased by $8.6 million.
• The total SG&A of $33.8 million for Q3 2025 included $7.8 million in non-cash stock-based compensation.

Research and Development (R&D) expenses are still present, though lower than the prior year, reflecting the transition of VYKAT XR manufacturing costs out of R&D and into COGS now that the product is approved. For the third quarter of 2025, R&D was $8.4 million, down significantly from $30.1 million in Q3 2024. This R&D spend supports pipeline expansion and other projects.

Regarding Cost of Goods Sold (COGS), it hit $1.1 million in Q3 2025, compared to zero in Q3 2024, driven by the sales of VYKAT XR. You should note that prior to FDA approval, manufacturing costs were expensed as R&D, so as the company sells through that zero-cost inventory, the COGS as a percentage of revenue will defintely rise over time.

Regulatory compliance and quality assurance costs are embedded within these figures. Specifically, the shift of manufacturing costs from R&D to COGS after the March 26, 2025 approval is a direct consequence of meeting post-marketing regulatory and quality requirements for the commercial product. The company also has contingent consideration liabilities related to the Essentialis merger, which are fair-valued, estimated at $19.5 million as of September 30, 2025, tied to future commercial milestones.

Finance: draft 13-week cash view by Friday.

Soleno Therapeutics, Inc. (SLNO) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Soleno Therapeutics, Inc.'s current financial picture, which is almost entirely centered on the successful U.S. launch of VYKAT XR for Prader-Willi Syndrome (PWS). The primary, and as of late 2025, sole, revenue stream is the Net product sales of VYKAT XR. For the third quarter ended September 30, 2025, Soleno Therapeutics reported net revenue from VYKAT XR sales of exactly $66.0 million. That figure more than doubled the $32.7 million in total net revenue generated in the second quarter of 2025, which is a defintely strong indicator of market uptake post-FDA approval on March 26, 2025. This revenue stream is entirely derived from Direct sales revenue from the U.S. PWS market, where VYKAT XR is the first and only FDA-approved therapy for hyperphagia in patients 4 years and older.

Here's a quick look at the sales performance and key adoption metrics that underpin that $66.0 million in Q3 2025 revenue:

Metric	Value	Context/Date
Net Product Sales (VYKAT XR)	$66.0 million	Three months ended September 30, 2025
Sequential Revenue Growth (Q2 to Q3 2025)	More than 100% increase	From $32.7 million in Q2 2025
Gross Profit Margin	98.1%	Q3 2025
Active Patients on Drug	764	As of September 30, 2025
Total Lives Covered by Insurance	Over 132 million	As of September 30, 2025
Cost of Goods Sold (COGS)	$1.1 million	Three months ended September 30, 2025

Beyond the immediate sales, the business model includes provisions for Potential future milestone payments from ex-U.S. licensing deals, though the current financial reporting reflects domestic sales milestones tied to the original Essentialis merger. Soleno Therapeutics carries a liability for contingent consideration payable upon achieving two commercial sales milestones of $100 million and $200 million in cumulative revenue. As of September 30, 2025, the fair value of this liability was estimated at $19.5 million. The total maximum cash payments obligated under this structure is up to $21.2 million, which you should track as a potential future cash outlay, even if the initial trigger events were based on U.S. sales performance.

Looking forward, the revenue potential extends to Future revenue from VYKAT XR in other rare genetic obesities. While no specific financial projections for these indications are public right now, the company's stated belief is that VYKAT XR has the potential to become a foundational therapy. This suggests a pipeline of future revenue streams contingent on successful development and regulatory approvals in adjacent markets. The current cash position of $556.1 million as of the end of Q3 2025, which includes $230 million from a July 2025 stock offering, is intended to fund the ongoing U.S. launch and support these future business activities.

• Primary revenue driver: VYKAT XR net sales in the U.S. PWS market.
• Q3 2025 Net Income: $26.0 million, marking profitability.
• Cash generated from operations in Q3 2025: $43.5 million.
• Contingent consideration liability fair value: $19.5 million as of September 30, 2025.
• Future revenue hinges on expanding indications beyond PWS.