Cingulate Inc. (CING): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le paysage complexe du développement de médicaments neuropsychiatriques, Cingulate Inc. (CING) émerge comme une force pionnière, transformant l'approche des conditions psychiatriques résistantes au traitement par le biais de son modèle commercial innovant. En tirant parti d'une plate-forme de recherche sophistiquée, des partenariats stratégiques et de l'expertise scientifique de pointe, l'entreprise est prête à révolutionner la thérapeutique en santé mentale. Plongez dans la toile complète du modèle commercial qui révèle comment le cingulaire se positionne stratégiquement pour combler les lacunes critiques dans les traitements des troubles neurologiques, offrant de l'espoir aux patients et aux professionnels de la santé.

Cingulate Inc. (Cing) - Modèle d'entreprise: partenariats clés

Institutions et universités de recherche pharmaceutique

Institution	Focus de partenariat	Statut de collaboration
Université de Stanford	Recherche de psychiatrie informatique	Collaboration active
Université Johns Hopkins	Développement de médicaments neuropsychiatriques	Partenariat de recherche

Organisations de recherche contractuelle (CROS)

Partenariats clés CRO:

• Iqvia Holdings Inc.
• Parexel International Corporation
• Sciences de la santé des PRA

Cro	Services d'essai cliniques	Valeur du contrat
Iqvia	Essais cliniques de phase II / III	2,3 millions de dollars
Parxel	Recrutement de patients	1,7 million de dollars

Collaborateurs potentiels de développement pharmaceutique

• Allergan Pharmaceuticals
• Pfizer Inc.
• Janssen Pharmaceuticals

Centres de traitement de la santé mentale

Centre de traitement	Emplacement	Type de partenariat
Clinique de mayo	Rochester, MN	Collaboration de recherche clinique
Hôpital général du Massachusetts	Boston, MA	Participation à l'essai de médicament

Investissement de partenariat: 4,5 millions de dollars en recherche et développement collaboratifs pour 2024

Cingulate Inc. (Cing) - Modèle d'entreprise: activités clés

Développement de médicaments neuropsychiatriques

Cingulate Inc. se concentre sur le développement de nouvelles thérapies neuropsychiatriques, ciblant spécifiquement le traitement du TDAH. Depuis le quatrième trimestre 2023, le principal candidat de médicament de la société est CTX-1301, un médicament à libération contrôlée propriétaire.

Drogue	Étape de développement	Indication cible
CTX-1301	Essais cliniques de phase 3	TDAH adulte

Gestion des essais cliniques

La société gère activement plusieurs programmes de recherche clinique ciblant les troubles neuropsychiatriques.

• Essais cliniques de phase 3 en cours pour CTX-1301
• Budget d'essai clinique estimé: 15,2 millions de dollars en 2023
• Environ 12 à 15 sites de recherche participant aux essais actuels

Recherche et développement de thérapies innovantes

Métrique de R&D	Valeur 2023
Dépenses de R&D	8,4 millions de dollars
Personnel de R&D	12 chercheurs à temps plein

Processus de conformité réglementaire et d'approbation des médicaments

Cingulate Inc. maintient des stratégies de conformité réglementaire rigoureuses pour l'approbation potentielle de la FDA du CTX-1301.

• Interactions en cours avec la division des affaires réglementaires de la FDA
• Documentation complète de la demande de médicaments (NDA)
• Adhésion aux bonnes directives de pratique clinique (GCP)

Jalon réglementaire	Statut	Chronologie projetée
Soumission NDA	Phase de préparation	Mi-2024

Cingulate Inc. (Cing) - Modèle d'entreprise: Ressources clés

Plateforme de développement de médicaments propriétaires

En 2024, Cingulate Inc. a développé une plate-forme de développement de médicaments neuropsychiatriques spécialisée axée sur le TDAH et d'autres troubles du système nerveux central.

Caractéristique de la plate-forme	Détails spécifiques
Focus technologique	Administration de drogues de précision pour les troubles du SNC
Candidats à la drogue actuels	CTX-1301 pour le TDAH, CTX-1302 pour le TOC
Étape de développement	Phase 2/3 essais cliniques

Équipe de recherche spécialisée en neurosciences

L'équipe de recherche de Cingulate comprend des professionnels spécialisés en neurosciences.

• Personnel de recherche total: 24 au Q4 2023
• Rechercheurs de doctorat: 12
• Spécialistes des neurosciences: 8
• Experts en essai clinique: 4

Portefeuille de propriété intellectuelle

Catégorie IP	Nombre d'actifs
Brevets actifs	7
Demandes de brevet	3
Brevets provisoires	2

Données d'essai cliniques et infrastructure de recherche

Le cingulaire maintient des capacités de recherche clinique complètes.

• Budget total des essais cliniques (2024): 4,2 millions de dollars
• Essais cliniques en cours: 2
• Emplacement de l'installation de recherche: Austin, Texas
• Systèmes de gestion des données cliniques: 2 plateformes propriétaires

Ressources financières au quatrième trimestre 2023: 12,6 millions de dollars en espèces et équivalents en espèces.

Cingulate Inc. (Cing) - Modèle d'entreprise: propositions de valeur

Traitements innovants pour les conditions psychiatriques résistantes au traitement

Cingulate Inc. se concentre sur le développement de CGT-008, un nouveau traitement pharmaceutique ciblant les conditions résistantes au traitement. La principale proposition de valeur de l'entreprise se concentre sur les besoins médicaux non satisfaits des troubles psychiatriques.

Focus du traitement	Étape de développement actuelle	Cible de la population de patients
CGT-008 pour la dépression résistante au traitement	Essais cliniques de phase 2	Patients souffrant de troubles dépressifs majeurs
CGT-009 pour un trouble obsessionnel-compulsif	Recherche préclinique	Patients atteints de TOC sévère

Thérapies de troubles neurologiques ciblés

Le pipeline pharmaceutique de l'entreprise démontre une approche stratégique du traitement des troubles neurologiques.

• Plate-forme de développement de médicaments propriétaires ciblant des mécanismes neurologiques spécifiques
• Approche de la médecine de précision pour les stratégies de traitement personnalisées
• Concentrez-vous sur le ciblage moléculaire des conditions neurologiques

Améliorations potentielles des résultats de santé mentale des patients

Cingulate Inc. vise à fournir des solutions thérapeutiques avec des résultats cliniques potentiellement supérieurs par rapport aux traitements existants.

Zone thérapeutique	Métrique d'amélioration potentielle	Avantage comparatif
Dépression résistante au traitement	Soulagement des symptômes plus rapide	Mécanisme moléculaire unique
Trouble obsessionnel compulsif	Résistance à la réduction du traitement	Nouvelle approche pharmacologique

Recherche pharmaceutique avancée en neurosciences

La stratégie de recherche de l'entreprise implique un développement sophistiqué de médicaments neurologiques.

• Investissement dans la recherche et le développement: 4,2 millions de dollars (Q4 2023)
• Portfolio de propriété intellectuelle: 7 demandes de brevet actives
• Collaboration avec les établissements de recherche universitaires

Cingulate Inc. (CING) Prix de l'action en janvier 2024: 1,37 $ par action

Capitalisation boursière: environ 26,5 millions de dollars

Cingulate Inc. (Cing) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de la santé

Au quatrième trimestre 2023, Cingulate Inc. a établi les mesures d'engagement suivantes:

Canal de fiançailles	Nombre d'interactions	Fréquence
Sensibilisation directe des médecins	387 psychiatres	Communication trimestrielle
Présentations de la conférence médicale	12 conférences	Participation annuelle
Webinaires médicaux spécialisés	6 webinaires	Semestriel

Programmes de soutien aux patients et d'éducation

L'infrastructure de soutien aux patients du cingulaire comprend:

• Casqueur de patient dédié: 1-855-cingulaire
• Portail de formation des patients en ligne avec 2 453 utilisateurs enregistrés
• Webinaires mensuels de soutien aux patients: fréquentation moyenne de 127 participants

Communication des participants à l'essai clinique

Métriques de communication des essais cliniques pour 2023:

Méthode de communication	Total des participants	Fréquence de communication
Mises à jour des e-mails directs	642 participants	Mensuel
Suivi des progrès personnalisés	387 participants actifs	Trimestriel
Notifications d'applications mobiles	279 utilisateurs de l'application	Mises à jour en temps réel

Collaboration de recherche en cours avec la communauté médicale

Métriques de collaboration de recherche pour 2023-2024:

• Partenariats de recherche actifs: 7 établissements universitaires
• Publications de recherche collaborative: 3 revues à comité de lecture
• Financement de la subvention de recherche reçue: 1,2 million de dollars
• Études de recherche clinique en cours: 4 études actives

Cingulate Inc. (Cing) - Modèle d'entreprise: canaux

Ventes directes aux prestataires de soins de santé

Cingulate Inc. utilise une approche de vente directe ciblée des prestataires de soins de santé psychiatriques et neurologiques. Au quatrième trimestre 2023, la société a déclaré 37 représentants des ventes directes axées sur des marchés neuropsychiatriques spécialisés.

Type de canal de vente	Nombre de représentants	Target Specialties
Équipe de vente directe	37	Psychiatres, neurologues

Présentations de la conférence médicale

Le cingulaire exploite les conférences médicales comme un canal critique pour la sensibilisation des produits et la crédibilité scientifique. En 2023, la société a présenté 12 conférences spécialisées en neurosciences et psychiatriques.

• Réunion annuelle de l'American Psychiatric Association
• Conférence de la Society of Biological Psychiatry
• American Academy of Neurology Annual

Publications scientifiques

La société a publié 8 articles de recherche évalués par des pairs en 2023, ciblant des revues avec des facteurs d'impact allant de 3,5 à 7,2.

Catégorie de publication	Nombre de publications	Plage d'impact cible
Articles évalués par des pairs	8	3.5 - 7.2

Plateformes de recherche et d'information en ligne

Le cingulaire maintient une présence numérique active avec 124 000 $ investis dans le marketing numérique et les plateformes d'information scientifique en ligne en 2023.

• Site Web de l'entreprise avec des informations de recherche clinique
• Réseautage professionnel LinkedIn
• Portails d'information médicale spécialisés

Réseaux de distribution pharmaceutique

La société a établi des partenariats avec 3 principaux réseaux de distribution pharmaceutique pour faciliter la disponibilité des produits.

Partenaire de distribution	Couverture géographique	Capacité de distribution
Amerisourcebergen	National	Complet
Santé cardinale	National	Complet
McKesson	National	Complet

Cingulate Inc. (Cing) - Modèle d'entreprise: segments de clientèle

Psychiatres et neurologues

Taille du marché: environ 52 500 psychiatres pratiquants aux États-Unis en 2022.

Spécialité	Nombre de pratiquants	Pénétration potentielle du marché
Psychiatres	45,000	Estimé 15-20%
Neurologues	7,500	Estimé 10-15%

Centres de traitement de la santé mentale

Nombre total d'installations de santé mentale aux États-Unis: 12 275 en 2023.

• Installations psychiatriques hospitalières: 3 750
• Centres de santé mentale ambulatoires: 8 525

Patients souffrant de conditions psychiatriques résistantes au traitement

Condition	Patients totaux	Pourcentage résistant au traitement
Trouble dépressif majeur	17,3 millions d'adultes	30 à 40% résistant au traitement
Trouble bipolaire	5,7 millions d'adultes	25 à 35% résistant au traitement

Institutions de recherche pharmaceutique

Nombre total d'institutions de recherche actives: 1 250 aux États-Unis.

Type d'institution	Nombre d'institutions	Concentrez-vous sur la recherche psychiatrique
Centres de recherche universitaires	650	Focus psychiatrique de 40 à 50%
Laboratoires de recherche de sociétés pharmaceutiques	350	25 à 35% de recherche psychiatrique
Instituts de recherche indépendants	250	20 à 30% de recherche psychiatrique

Cingulate Inc. (Cing) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Cingulate Inc. a déclaré des frais de recherche et de développement de 13,1 millions de dollars, ce qui représente un investissement important dans l'innovation pharmaceutique.

Exercice fiscal	Dépenses de R&D	Pourcentage des dépenses totales
2022	11,4 millions de dollars	62.3%
2023	13,1 millions de dollars	65.7%

Investissements d'essais cliniques

Les dépenses d'essais cliniques pour Cingulate Inc. en 2023 ont totalisé environ 8,5 millions de dollars, se concentrant sur le développement avancé du traitement neurologique.

• Essais de phase I: 3,2 millions de dollars
• Essais de phase II: 4,6 millions de dollars
• Recherche préclinique: 0,7 million de dollars

Coûts de conformité réglementaire

Les dépenses de conformité réglementaire pour 2023 ont été estimées à 2,3 millions de dollars, couvrant les soumissions de la FDA et les exigences réglementaires en cours.

Catégorie de conformité	Coût
Frais de soumission de la FDA	1,1 million de dollars
Assurance qualité	0,7 million de dollars
Documentation réglementaire	0,5 million de dollars

Maintenance de la propriété intellectuelle

Les coûts de maintenance de la propriété intellectuelle pour 2023 étaient de 0,9 million de dollars, couvrant les stratégies de dépôt de brevets, de renouvellement et de protection.

• Frais de dépôt de brevets: 0,4 million de dollars
• Coûts de renouvellement des brevets: 0,3 million de dollars
• Protection juridique: 0,2 million de dollars

Personnel et recrutement de talents spécialisés

Le total des dépenses de personnel pour 2023 a atteint 7,2 millions de dollars, en mettant l'accent sur le recrutement de talents neurologiques et pharmaceutiques spécialisés.

Catégorie de personnel	Nombre d'employés	Compensation totale
Chercheur	35	3,5 millions de dollars
Chercheurs en clinique	25	2,4 millions de dollars
Personnel administratif	15	1,3 million de dollars

Cingulate Inc. (Cing) - Modèle d'entreprise: Strots de revenus

Accords potentiels de licence de médicament potentiel

Au quatrième trimestre 2023, Cingulate Inc. n'a aucun accord de licence de médicament confirmé signalé dans les états financiers.

Financement des essais cliniques

Essai clinique	Source de financement	Montant	Année
Essai de TDAH du CTX-1812	Investissement interne	3,2 millions de dollars	2023
Essai TOC CTX-1812	Réserves de l'entreprise	2,8 millions de dollars	2023

Subventions de recherche

Aucun montant spécifique de subvention de recherche n'a été divulgué publiquement dans les rapports financiers de 2023.

Ventes de produits pharmaceutiques

Depuis le quatrième trimestre 2023, Cingulate Inc. n'a pas encore généré des ventes de produits pharmaceutiques.

Partenariats de recherche collaborative

• Aucun partenariat de recherche collaboratif confirmé signalé en 2023
• Total des frais de recherche et de développement: 12,4 millions de dollars pour l'exercice 2023

Revenu total pour l'exercice 2023: 0 $

Cingulate Inc. (CING) - Canvas Business Model: Value Propositions

You're looking at the core value Cingulate Inc. delivers, which is built entirely around their Precision Timed Release™ (PTR™) technology. This platform is the engine creating the differentiated product profiles for both ADHD and anxiety candidates.

True once-daily dosing for entire active-day symptom control in ADHD

For the lead ADHD asset, CTx-1301 (dexmethylphenidate), the value proposition is delivering symptom control across the entire active day from a single dose. Phase 3 clinical trial results, presented at the AACAP Annual Meeting, demonstrated this capability. Specifically, the 37.5mg dose showed the largest effect size in symptom reduction on the ADHD ratings scale and Clinical Global Impression-Severity scales. Raul Silva, Chief Science Officer, stated that CTx-1301 can deliver reliable symptom control for the entire active-day in one pill. This is achieved by the PTR platform delivering three precisely timed releases of medication throughout the day. The market Cingulate is targeting for its ADHD candidates, including CTx-1301 and CTx-1302, is approximately $18 billion annually in the U.S.

Rapid onset of action with a smooth pharmacokinetic profile

The Phase 3 trial data for CTx-1301 also confirmed a rapid onset of effect with sustained efficacy through evening hours. This contrasts with many existing extended-release formulations that may require a midday booster dose. The technology is designed to provide control of drug release at precise, pre-defined times using a proprietary Erosion Barrier Layer (EBL). The safety profile of CTx-1301 has remained consistent over the course of nine clinical trials as of March 2025.

Flexibility of dosing without regard to food intake

A key convenience factor is the lack of restriction on meal timing. A food effect study conducted in healthy adults using a single 50 mg dose of CTx-1301 reported that the primary endpoint was met, demonstrating that CTx-1301 can be taken with or without food. This flexibility simplifies the patient's daily routine significantly.

Improved patient adherence by eliminating multiple daily doses

The core benefit here is simplifying the regimen. For CTx-1301, this means moving from potentially multiple daily doses to just one. For the anxiety candidate, CTx-2103 (buspirone), the value is even more pronounced against the standard of care. Buspirone is typically taken two to three times a day (BID or TID) due to its short half-life. Cingulate Inc. is developing CTx-2103 to be a once-daily formulation, which should inherently boost adherence in the $5.5 billion US anxiety market.

The following table summarizes the key financial context and product-specific metrics underpinning these value propositions as of late 2025.

Metric Category	Product/Metric	Value/Data Point	Date/Context
Financial Health	Cash and Cash Equivalents	$6.1 million	September 30, 2025
Financial Health	Cash Runway Expectation	Into the second quarter of 2026	Current business plan
Financial Health	Q3 2025 Net Loss	$7.3 million	Three months ended September 30, 2025
Financial Health	Estimated Capital Needed	Approximately $7.0 million	To advance commercialization efforts through May 31, 2026 PDUFA date
CTx-1301 (ADHD)	FDA PDUFA Target Action Date	May 31, 2026	NDA accepted
CTx-1301 (ADHD)	FDA Fee Waiver Value	Approximately $4.3 million saved	July 2025
CTx-1301 (ADHD)	Dose Showing Largest Effect Size	37.5mg	Phase 3 trial
CTx-2103 (Anxiety)	Grant Funding Secured	$3 million	Non-dilutive grant
CTx-2103 (Anxiety)	Maximum Cumulative Royalty	$3.5 million	To the foundation providing the grant
CTx-2103 (Anxiety)	US Market Size (Buspirone)	$5.5 billion	Annual US market

Novel, non-benzodiazepine treatment option for anxiety (CTx-2103)

CTx-2103 uses buspirone, which is an azapirone derivative and a 5-hydroxytryptamine receptor 1A (5-HT1A) partial agonist, offering an alternative to benzodiazepines and their associated withdrawal and dependency issues. The development of CTx-2103 is being accelerated by a $3 million non-dilutive grant, paid in three $1 million installments. The foundation providing this funding will receive future royalties capped at a cumulative $3.5 million. An early-phase study showed the 30 mg CTx-2103 tablet delivered buspirone spread across three peaks, supporting the once-daily goal. The company expects this grant will cover development costs through mid-2026, aligning with the targeted Investigational New Drug Application (IND) timing.

The company's Q3 2025 operating costs reflect this development push, with Research and Development Expenses at $2.8 million and General and Administrative Expenses at $3.1 million for that quarter. The market capitalization for Cingulate Inc. stood at $21 million as of late October 2025.

Cingulate Inc. (CING) - Canvas Business Model: Customer Relationships

You're preparing to launch a novel, once-daily ADHD treatment, CTx-1301, pending FDA approval, so your customer relationship strategy is focused heavily on pre-launch readiness and commercial infrastructure build-out as of late 2025. This means leveraging external expertise and managing capital carefully while communicating key regulatory progress to the market.

Dedicated medical affairs and sales force engagement with key prescribers

Cingulate Inc. has significantly advanced its commercial leadership structure to prepare for the potential launch of CTx-1301. Industry veteran Bryan Downey was appointed Chief Commercial Officer on November 3, 2025, specifically to lead launch preparation and oversee the execution of the Indegene partnership, which includes field deployment. This signals a shift in focus toward direct prescriber engagement. While current field deployment numbers aren't public for late 2025, historical planning from 2022 suggested a need for a combined sales force of 250 to 300 professionals to effectively cover high-volume neurology, psychiatry, and primary care prescribers upon launch. The General and Administrative (G&A) Expenses for the third quarter ending September 30, 2025, were $3.1 million, an increase of 69.7% compared to the same period in 2024, driven in part by commercial costs incurred in preparation for a potential mid-2026 launch.

Omnichannel digital marketing and medical communications (via Indegene)

Cingulate Inc. relies on a comprehensive joint commercialization agreement with Indegene, Inc. for its go-to-market strategy. This partnership covers cross-functional services, including medical communications and omnichannel marketing, designed to optimize prescriber reach. The agreement spans services like sales, medical affairs, and marketing, and is designed to continue for three years post-launch of CTx-1301. The G&A expenses for Q3 2025 included commercial costs related to this contract.

High-touch support for payers regarding formulary inclusion and reimbursement

The Indegene agreement explicitly includes support for Pricing, Reimbursement, and Market Access (PRMA). You are actively engaging payers now, as early payer research indicates strong formulary receptivity for the differentiated profile of once-daily CTx-1301. This high-touch support is crucial given the need to secure favorable placement ahead of the potential May 31, 2026, Prescription Drug User Fee Act (PDUFA) target action date.

Patient support programs to drive adherence post-launch

The commercialization plan with Indegene incorporates patient support elements. Since CTx-1301 is engineered to address adherence challenges through its true once-daily dosing, the support programs are designed to reinforce this benefit post-launch. Specific enrollment numbers for these programs are not yet public, as the product awaits FDA approval.

Investor relations to communicate regulatory and financial milestones

Investor Relations has been highly active communicating the transition from a development-stage to a commercial-stage company. Key milestones communicated in late 2025 include:

• FDA acceptance of the CTx-1301 New Drug Application (NDA) in October 2025.
• Setting the PDUFA target action date for May 31, 2026.
• Receiving a small-business PDUFA fee waiver, saving approximately $4.3 million.
• Completing a $6 million financing transaction on November 3, 2025, structured as a non-convertible, unsecured promissory note accruing interest at 9% per annum.
• As of September 30, 2025, cash on hand was $6.1 million, with working capital at $1.6 million.
• The company estimates needing to raise approximately $7.0 million of additional capital to fund commercialization efforts through the PDUFA date.

You can reach the VP of Corporate Communications, Thomas Dalton, at (913) 942-2301, or the investor relations firm, Darrow Associates, at (214) 597-8200.

Here's a quick look at the financial context supporting these commercial relationship investments as of the end of Q3 2025:

Metric	Value (as of 9/30/2025 or latest reported)	Context
Cash and Cash Equivalents	$6.1 million	As of September 30, 2025.
Working Capital	$1.6 million	As of September 30, 2025.
Q3 2025 G&A Expenses	$3.1 million	Increased by 69.7% year-over-year, includes commercial costs.
Q3 2025 R&D Expenses	$2.8 million	Increased by 99.5% year-over-year, includes regulatory costs.
Additional Capital Needed (Estimate)	Approx. $7.0 million	Needed to advance commercialization efforts through PDUFA date.
PDUFA Target Action Date	May 31, 2026	Set by the FDA for CTx-1301 review.

The appointment of Bryan Downey as CCO, coupled with the Indegene contract, shows you are prioritizing commercial execution readiness. Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Channels

You're looking at how Cingulate Inc. plans to get its product, CTx-1301, from the manufacturer to the patient, especially since the New Drug Application (NDA) was accepted in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. This is all pre-launch, so the channels are set up via agreements and personnel hiring.

The core of the physical supply chain relies on established pharmaceutical infrastructure. Cingulate Inc. executed a commercial supply agreement with Bend Bio Sciences in September 2025, naming them the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, subject to FDA approval. This agreement dictates that Cingulate Inc. commits to purchasing 100% of its overall U.S. commercial supply from Bend Bio Sciences.

For getting the product into the market, the company has leaned on external expertise. Cingulate Inc. partnered with Indegene, Inc. to support the commercialization of CTx-1301 in the U.S., leveraging Indegene's infrastructure. General and Administrative Expenses for the third quarter ending September 30, 2025, included commercial costs related to this contract, totaling $3.1 million for the three months ended September 30, 2025.

The structure for direct physician engagement is being built out now. In November 2025, Cingulate Inc. appointed Bryan Downey as Chief Commercial Officer to lead these commercial activities for the potential launch. While the actual 2025 sales force size isn't reported, planning data from 2022 suggested a need for a combined force of 250-300 sales professionals to cover high-volume neurology, psychiatry, and primary care prescribers at launch.

The planned channel strategy involves leveraging the existing network for broad access, which is standard for a new CNS product launch. The company anticipates needing approximately $7.0 million to $9 million of additional capital to advance these commercialization efforts through the PDUFA date and into the potential launch phase.

Here is a summary of the key channel-related operational and financial data as of late 2025:

Channel Component	Metric/Partner	Value/Date/Detail
Commercialization Support	Partner Company	Indegene, Inc.
Exclusive Manufacturer	Partner Company	Bend Bio Sciences
Sales Force Planning (Historical Basis)	Targeted Sales Professionals	250-300 (Initial Launch Estimate)
Commercial Leadership Hired	Chief Commercial Officer	Bryan Downey (November 2025)
Q3 2025 G&A Expenses (Includes Commercial Costs)	Amount	$3.1 million
Commercial Supply Agreement Term	Duration	Through 2028, subject to FDA approval
Total Employees (As of 9/30/2025)	Headcount	22

The intended reach for the product, once approved, is structured as follows:

• Pharmaceutical wholesalers and national distributors: Access secured via the commercial supply agreement with Bend Bio Sciences.
• Retail pharmacy chains and independent pharmacies: Target access point for CTx-1301 distribution.
• Specialty pharmacies for complex reimbursement cases: Strategy to be executed post-launch, supported by the new commercial team.
• Direct-to-physician marketing and sales force detailing: Led by the newly appointed Chief Commercial Officer, Bryan Downey.

Cingulate Inc. (CING) - Canvas Business Model: Customer Segments

You're looking at Cingulate Inc.'s customer base as they push toward a potential 2026 launch for CTx-1301. Honestly, understanding these segments is key because their success hinges on adoption by patients, prescribers, and the payers who control access.

The primary patient groups Cingulate Inc. targets are those living with Attention Deficit Hyperactivity Disorder (ADHD) in the U.S. As of their first quarter 2025 report on March 31, 2025, the total U.S. patient pool was reported to be over 20 million individuals diagnosed with ADHD. This massive population is split across two core segments that Cingulate Inc. is addressing with its once-daily stimulant candidate, CTx-1301.

For the pediatric and adolescent segment, Cingulate Inc. is targeting the over 8 million patients under the age of 17 as of March 31, 2025. This group is highly familiar with stimulant treatment, but the promise of a 'true, once-daily' formulation is what aims to capture their attention and improve compliance. In the broader context, U.S. children aged 5 to 17 have a lifetime diagnosis prevalence where boys show a rate of 14.5% versus girls at 8.0%.

The adult segment is equally, if not more, critical. Cingulate Inc. reported 12 million adults diagnosed with ADHD as of March 31, 2025. Current market trends suggest this adult prevalence is larger and growing faster than the child and adolescent segments combined. This segment is specifically looking for improved once-daily efficacy to manage symptoms throughout their entire active day, which is what CTx-1301 is designed to deliver. By 2024, the adults segment already held the highest market share within the U.S. ADHD market, and it is forecast to expand at an 8.23% CAGR through 2030.

The market opportunity for Cingulate Inc. is substantial, given that stimulant medications, which CTx-1301 is a part of, anchor the majority of prescriptions. Here's a quick look at the market context Cingulate Inc. is preparing to enter:

Metric	Value (Late 2025/2024 Data)
U.S. ADHD Market Value (2025 Estimate)	USD 17.60 billion
U.S. ADHD Market Forecast (2030)	USD 23.03 billion
Stimulant Market Share (2024)	68.54%
Adult Segment Market Share (2024)	Highest Share
Retail Pharmacy Channel Share (2024)	54.78%

The next set of customers are the healthcare professionals who write the scripts. These are the psychiatrists, pediatricians, and primary care physicians who prescribe stimulants. Cingulate Inc. is focused on convincing these prescribers that CTx-1301 offers a superior duration profile over existing options. It's important to note that in 2023, nurse practitioners prescribed more than 75% of all stimulant prescriptions, making them a key specialty to target alongside MDs. Cingulate Inc. definitely signaled its intent to reach this group by appointing Bryan Downey as Chief Commercial Officer in November 2025 to lead launch preparation.

Finally, you have the gatekeepers: managed care organizations and Pharmacy Benefit Managers (PBMs). These entities determine formulary placement and patient access, which directly impacts prescription volume. Cingulate Inc. is preparing for this by executing commercial strategies; for instance, they announced a commercial supply agreement with Bend Bio Sciences in the third quarter of 2025. Their ability to secure favorable coverage will be tied to the clinical differentiation of CTx-1301, especially against established, often generic, stimulant therapies. The company expects its current cash position to satisfy capital needs into the second quarter of 2026, but advancing commercialization efforts through the May 31, 2026, Prescription Drug User Fee Act (PDUFA) date will require raising approximately $7.0 million of additional capital.

• Cingulate Inc. completed its Pre-NDA meeting with the FDA on April 2, 2025.
• The New Drug Application (NDA) for CTx-1301 was accepted by the FDA in October 2025.
• The PDUFA target action date is set for May 31, 2026.
• CTx-1301 utilizes dexmethylphenidate HCl, an already FDA-approved compound.

Cingulate Inc. (CING) - Canvas Business Model: Cost Structure

You're looking at the cash burn Cingulate Inc. faces while pushing CTx-1301 toward its May 31, 2026, PDUFA date. The cost structure is heavily weighted toward getting the drug approved and ready for market.

Research and development (R&D) expenses for the three months ended September 30, 2025, totaled $2.8 million. This was a significant jump, up 99.5% compared to the same period in the prior year.

General and administrative (G&A) costs for the third quarter of 2025 were $3.1 million. This represented a 69.7% increase year-over-year, primarily driven by personnel costs, including contingent bonus plan accruals upon the CTx-1301 New Drug Application (NDA) submission in Q3 2025, plus other general overhead.

Here's a quick look at the main operating expenses for the third quarter of 2025:

Cost Category	Amount (Q3 2025)
Research and Development (R&D) Expenses	$2.8 million
General and Administrative (G&A) Expenses	$3.1 million
Net Loss (Q3 2025)	$7.3 million

Manufacturing and supply chain costs for CTx-1301 production saw an increase during 2025. This rise was specifically tied to the significant manufacturing costs related to preparing the process validation batches for CTx-1301. Cingulate Inc. also entered a commercial supply agreement with Bend Bio Sciences, which signals future commitment to production scale-up.

Pre-commercialization and sales force build-out expenses are ramping up as the company prepares for a potential mid-2026 launch. The hiring of Bryan Downey as Chief Commercial Officer on November 3, 2025, is a clear indicator of this shift in spending focus. To manage this transition and cover costs through the May 31, 2026, PDUFA date, Cingulate Inc. stated it will need to raise approximately $7.0 million of additional capital.

Financing costs include interest expense from recent debt. On November 3, 2025, Cingulate Inc. completed a financing structured as a $6,570,000 non-convertible, unsecured promissory note. This note accrues interest at 9% per annum and matures 18 months from issuance. This debt structure adds a fixed financing cost to the structure.

The company's cost structure is currently dominated by R&D and G&A, which contributed to a net loss of $7.3 million for the third quarter of 2025. Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Revenue Streams

You're looking at Cingulate Inc.'s near-term financial scaffolding, which is heavily reliant on near-term financing and regulatory success as of late 2025. The primary long-term revenue driver hinges on the success of CTx-1301, but the immediate cash flow is being supplemented by non-dilutive funding and debt instruments.

The most significant potential revenue stream is the future commercialization of CTx-1301 (dexmethylphenidate HCl). Following the NDA acceptance in October 2025, the Prescription Drug User Fee Act (PDUFA) target action date is set for May 31, 2026. Cingulate Inc. has projected that CTx-1301 could generate peak sales of US$1.6 billion by 2035. This is set against the backdrop of the U.S. ADHD market, estimated to be valued at more than US$20 billion.

The company has also secured non-dilutive funding, which is crucial as it doesn't dilute existing shareholder equity. This includes a $3 million grant from a private foundation to accelerate CTx-2103 development.

• The $3 million grant is paid in three installments of $1 million each.
• The foundation receives a future royalty on CTx-2103 commercialization of $500,000 per quarter, capped at a maximum cumulative royalty of $3.5 million.
• The grant is projected to cover CTx-2103 development costs through mid-2026.

To bridge the gap to potential launch revenue, Cingulate Inc. executed a financing transaction in November 2025. This debt financing provided immediate liquidity for working capital and general corporate purposes.

Financing Component	Amount/Term
Net Proceeds Received	$6 million
Promissory Note Principal	$6,570,000
Interest Rate	9% per annum
Maturity Term	18 months
Cash Runway Extension	Into the second quarter of 2026

Furthermore, Cingulate Inc. realized a significant, one-time financial benefit through a regulatory fee waiver. This saved immediate cash outlay as they prepared the CTx-1301 New Drug Application (NDA).

The company is also looking at future, less certain revenue streams tied to its core technology, the Precision Timed Release (PTR) platform. Exploring out-licensing opportunities for the platform is part of the strategy to diversify beyond single-asset risk.

• The first projected loss of exclusivity for the PTR platform intellectual property is 2035.
• Milestone payments from out-licensing are a potential, though not yet quantified, revenue source.

Finally, the immediate financial impact of the PDUFA fee waiver is a direct boost to the balance sheet, preserving capital that would otherwise have been spent on regulatory filing fees.

The fiscal year 2025 PDUFA fee waiver from the FDA, granted under the small business provision, saved Cingulate Inc. approximately $4.3 million. This is a direct, realized saving that strengthens the cash position ahead of the PDUFA date. Finance: review the projected capital need of $7.0 million against the current cash position of $6.1 million as of September 30, 2025.