Cingulate Inc. (CING): Business Model Canvas

In der komplexen Landschaft der neuropsychiatrischen Arzneimittelentwicklung erweist sich Cingulate Inc. (CING) als Vorreiter und verändert durch sein innovatives Geschäftsmodell den Ansatz für behandlungsresistente psychiatrische Erkrankungen. Durch die Nutzung einer hochentwickelten Forschungsplattform, strategischer Partnerschaften und modernster wissenschaftlicher Expertise ist das Unternehmen bereit, die Therapie der psychischen Gesundheit zu revolutionieren. Tauchen Sie ein in das umfassende Business Model Canvas, das zeigt, wie Cingulate sich strategisch positioniert, um kritische Lücken bei der Behandlung neurologischer Störungen zu schließen und Patienten und medizinischem Fachpersonal gleichermaßen Hoffnung zu geben.

Cingulate Inc. (CING) – Geschäftsmodell: Wichtige Partnerschaften

Pharmazeutische Forschungseinrichtungen und Universitäten

Institution	Partnerschaftsfokus	Kooperationsstatus
Stanford-Universität	Computergestützte Psychiatrieforschung	Aktive Zusammenarbeit
Johns Hopkins Universität	Neuropsychiatrische Arzneimittelentwicklung	Forschungspartnerschaft

Auftragsforschungsinstitute (CROs)

Wichtige CRO-Partnerschaften:

• IQVIA Holdings Inc.
• Parexel International Corporation
• PRA Gesundheitswissenschaften

CRO	Dienstleistungen für klinische Studien	Vertragswert
IQVIA	Klinische Studien der Phase II/III	2,3 Millionen US-Dollar
Parexel	Patientenrekrutierung	1,7 Millionen US-Dollar

Potenzielle Kooperationspartner für die pharmazeutische Entwicklung

• Allergan Pharmaceuticals
• Pfizer Inc.
• Janssen Pharmaceuticals

Behandlungszentren für psychische Gesundheit

Behandlungszentrum	Standort	Partnerschaftstyp
Mayo-Klinik	Rochester, MN	Klinische Forschungskooperation
Massachusetts General Hospital	Boston, MA	Teilnahme an Arzneimittelstudien

Partnerschaftsinvestition: 4,5 Millionen US-Dollar für gemeinsame Forschung und Entwicklung für 2024

Cingulate Inc. (CING) – Geschäftsmodell: Hauptaktivitäten

Neuropsychiatrische Arzneimittelentwicklung

Cingulate Inc. konzentriert sich auf die Entwicklung neuartiger neuropsychiatrischer Therapeutika, die speziell auf die Behandlung von ADHS abzielen. Im vierten Quartal 2023 ist CTx-1301 der wichtigste Arzneimittelkandidat des Unternehmens, ein proprietäres Medikament mit kontrollierter Freisetzung.

Arzneimittelkandidat	Entwicklungsphase	Zielanzeige
CTx-1301	Klinische Studien der Phase 3	ADHS bei Erwachsenen

Klinisches Studienmanagement

Das Unternehmen verwaltet aktiv mehrere klinische Forschungsprogramme, die auf neuropsychiatrische Erkrankungen abzielen.

• Laufende klinische Phase-3-Studien für CTx-1301
• Geschätztes Budget für klinische Studien: 15,2 Millionen US-Dollar im Jahr 2023
• Ungefähr 12–15 Forschungsstandorte nehmen an aktuellen Studien teil

Forschung und Entwicklung innovativer Therapeutika

F&E-Metrik	Wert 2023
F&E-Ausgaben	8,4 Millionen US-Dollar
F&E-Personal	12 Vollzeitforscher

Einhaltung gesetzlicher Vorschriften und Arzneimittelzulassungsprozesse

Cingulate Inc. verfolgt strenge Richtlinien zur Einhaltung gesetzlicher Vorschriften für eine mögliche FDA-Zulassung von CTx-1301.

• Laufende Interaktion mit der Abteilung für regulatorische Angelegenheiten der FDA
• Umfassende Dokumentation für New Drug Application (NDA)
• Einhaltung der Good Clinical Practice (GCP)-Richtlinien

Regulatorischer Meilenstein	Status	Projizierte Zeitleiste
NDA-Einreichung	Vorbereitungsphase	Mitte 2024

Cingulate Inc. (CING) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelentwicklungsplattform

Seit 2024 hat Cingulate Inc. eine spezialisierte Entwicklungsplattform für neuropsychiatrische Medikamente entwickelt, die sich auf ADHS und andere Erkrankungen des Zentralnervensystems konzentriert.

Plattformcharakteristik	Spezifische Details
Technologiefokus	Präzise Arzneimittelabgabe bei ZNS-Erkrankungen
Aktuelle Medikamentenkandidaten	CTx-1301 für ADHS, CTx-1302 für Zwangsstörungen
Entwicklungsphase	Klinische Studien der Phasen 2/3

Spezialisiertes neurowissenschaftliches Forschungsteam

Das Forschungsteam von Cingulate besteht aus spezialisierten Neurowissenschaftlern.

• Gesamtzahl der Forschungsmitarbeiter: 24, Stand 4. Quartal 2023
• Forscher auf Doktorandenniveau: 12
• Neurowissenschaftliche Spezialisten: 8
• Experten für klinische Studien: 4

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Aktive Patente	7
Patentanmeldungen	3
Vorläufige Patente	2

Daten und Forschungsinfrastruktur für klinische Studien

Cingulate verfügt über umfassende klinische Forschungskapazitäten.

• Gesamtbudget für klinische Studien (2024): 4,2 Millionen US-Dollar
• Laufende klinische Studien: 2
• Standort der Forschungseinrichtung: Austin, Texas
• Klinische Datenmanagementsysteme: 2 proprietäre Plattformen

Finanzielle Ausstattung ab Q4 2023: 12,6 Millionen US-Dollar an Barmitteln und Barmitteläquivalenten.

Cingulate Inc. (CING) – Geschäftsmodell: Wertversprechen

Innovative Behandlungen für behandlungsresistente psychiatrische Erkrankungen

Cingulate Inc. konzentriert sich auf die Entwicklung von CGT-008, einer neuartigen pharmazeutischen Behandlung gegen behandlungsresistente Erkrankungen. Das primäre Wertversprechen des Unternehmens konzentriert sich auf die Deckung ungedeckter medizinischer Bedürfnisse bei psychiatrischen Erkrankungen.

Behandlungsschwerpunkt	Aktueller Entwicklungsstand	Zielgruppe der Patienten
CGT-008 für behandlungsresistente Depression	Klinische Studien der Phase 2	Patienten mit schwerer depressiver Störung
CGT-009 für Zwangsstörung	Präklinische Forschung	Patienten mit schwerer Zwangsstörung

Gezielte Therapien neurologischer Störungen

Die pharmazeutische Pipeline des Unternehmens zeigt einen strategischen Ansatz zur Behandlung neurologischer Störungen.

• Proprietäre Plattform zur Arzneimittelentwicklung, die auf bestimmte neurologische Mechanismen abzielt
• Präzisionsmedizinischer Ansatz für personalisierte Behandlungsstrategien
• Konzentrieren Sie sich auf das molekulare Targeting neurologischer Erkrankungen

Potenzielle Verbesserungen der psychischen Gesundheit der Patienten

Cingulate Inc. zielt darauf ab, therapeutische Lösungen mit potenziell besseren klinischen Ergebnissen im Vergleich zu bestehenden Behandlungen bereitzustellen.

Therapeutischer Bereich	Potenzielle Verbesserungsmetrik	Komparativer Vorteil
Behandlungsresistente Depression	Schnellere Linderung der Symptome	Einzigartiger molekularer Mechanismus
Zwangsstörung	Reduzierter Behandlungswiderstand	Neuartiger pharmakologischer Ansatz

Fortgeschrittene pharmazeutische Forschung in den Neurowissenschaften

Die Forschungsstrategie des Unternehmens umfasst die Entwicklung anspruchsvoller neurologischer Medikamente.

• Investitionen in Forschung und Entwicklung: 4,2 Millionen US-Dollar (4. Quartal 2023)
• Portfolio an geistigem Eigentum: 7 aktive Patentanmeldungen
• Zusammenarbeit mit akademischen Forschungseinrichtungen

Aktienkurs von Cingulate Inc. (CING), Stand Januar 2024: 1,37 USD pro Aktie

Marktkapitalisierung: Ungefähr 26,5 Millionen US-Dollar

Cingulate Inc. (CING) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Seit dem vierten Quartal 2023 hat Cingulate Inc. die folgenden Engagement-Kennzahlen festgelegt:

Engagement-Kanal	Anzahl der Interaktionen	Häufigkeit
Direkte Kontaktaufnahme mit Ärzten	387 Psychiater	Vierteljährliche Kommunikation
Präsentationen auf medizinischen Konferenzen	12 Konferenzen	Jährliche Teilnahme
Spezialisierte medizinische Webinare	6 Webinare	Halbjährlich

Patientenunterstützungs- und Aufklärungsprogramme

Die Patientenunterstützungsinfrastruktur von Cingulate umfasst:

• Spezielle Patienten-Hotline: 1-855-CINGULATE
• Online-Portal zur Patientenaufklärung mit 2.453 registrierten Benutzern
• Monatliche Webinare zur Patientenunterstützung: Durchschnittliche Teilnahme von 127 Teilnehmern

Kommunikation mit Teilnehmern klinischer Studien

Kommunikationskennzahlen für klinische Studien für 2023:

Kommunikationsmethode	Gesamtzahl der Teilnehmer	Kommunikationshäufigkeit
Direkte E-Mail-Updates	642 Teilnehmer	Monatlich
Personalisierte Fortschrittsverfolgung	387 aktive Teilnehmer	Vierteljährlich
Benachrichtigungen für mobile Apps	279 App-Nutzer	Echtzeit-Updates

Laufende Forschungszusammenarbeit mit der medizinischen Gemeinschaft

Kennzahlen zur Forschungszusammenarbeit für 2023–2024:

• Aktive Forschungskooperationen: 7 akademische Einrichtungen
• Kollaborative Forschungspublikationen: 3 peer-reviewte Zeitschriften
• Erhaltene Forschungsstipendien: 1,2 Millionen US-Dollar
• Laufende klinische Forschungsstudien: 4 aktive Studien

Cingulate Inc. (CING) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitsdienstleister

Cingulate Inc. nutzt einen gezielten Direktvertriebsansatz an psychiatrische und neurologische Gesundheitsdienstleister. Im vierten Quartal 2023 meldete das Unternehmen 37 Direktvertriebsmitarbeiter, die sich auf spezialisierte neuropsychiatrische Märkte konzentrieren.

Vertriebskanaltyp	Anzahl der Vertreter	Zielspezialitäten
Direktvertriebsteam	37	Psychiater, Neurologen

Präsentationen auf medizinischen Konferenzen

Cingulate nutzt medizinische Konferenzen als entscheidenden Kanal für Produktbekanntheit und wissenschaftliche Glaubwürdigkeit. Im Jahr 2023 präsentierte sich das Unternehmen auf 12 Fachkonferenzen für Neurowissenschaften und Psychiatrie.

• Jahrestagung der American Psychiatric Association
• Konferenz der Gesellschaft für Biologische Psychiatrie
• Jahrestagung der American Academy of Neurology

Wissenschaftliche Veröffentlichungen

Das Unternehmen veröffentlichte im Jahr 2023 acht peer-reviewte Forschungsartikel, die sich an Zeitschriften mit Impact-Faktoren zwischen 3,5 und 7,2 richteten.

Publikationskategorie	Anzahl der Veröffentlichungen	Zielauftreffbereich
Von Experten begutachtete Artikel	8	3.5 - 7.2

Online-Recherche- und Informationsplattformen

Cingulate unterhält eine aktive digitale Präsenz mit 124.000 US-Dollar wurden in digitales Marketing und Online-Plattformen für wissenschaftliche Informationen investiert im Jahr 2023.

• Unternehmenswebsite mit Informationen zur klinischen Forschung
• Professionelles Networking auf LinkedIn
• Spezialisierte medizinische Informationsportale

Pharmazeutische Vertriebsnetze

Das Unternehmen hat Partnerschaften mit drei großen pharmazeutischen Vertriebsnetzen aufgebaut, um die Produktverfügbarkeit zu erleichtern.

Vertriebspartner	Geografische Abdeckung	Vertriebsfähigkeit
AmerisourceBergen	National	Umfassend
Kardinalgesundheit	National	Umfassend
McKesson	National	Umfassend

Cingulate Inc. (CING) – Geschäftsmodell: Kundensegmente

Psychiater und Neurologen

Marktgröße: Ungefähr 52.500 praktizierende Psychiater in den Vereinigten Staaten im Jahr 2022.

Spezialität	Anzahl der Praktizierenden	Potenzielle Marktdurchdringung
Psychiater	45,000	Geschätzte 15-20 %
Neurologen	7,500	Geschätzte 10-15 %

Behandlungszentren für psychische Gesundheit

Gesamtzahl der psychiatrischen Einrichtungen in den USA: 12.275 (Stand 2023).

• Stationäre psychiatrische Einrichtungen: 3.750
• Ambulante psychiatrische Zentren: 8.525

Patienten mit behandlungsresistenten psychiatrischen Erkrankungen

Zustand	Gesamtzahl der Patienten	Behandlungsresistenter Prozentsatz
Schwere depressive Störung	17,3 Millionen Erwachsene	30–40 % behandlungsbeständig
Bipolare Störung	5,7 Millionen Erwachsene	25–35 % behandlungsbeständig

Pharmazeutische Forschungseinrichtungen

Gesamtzahl aktiver Forschungseinrichtungen: 1.250 in den Vereinigten Staaten.

Institutionstyp	Anzahl der Institutionen	Schwerpunkt psychiatrische Forschung
Akademische Forschungszentren	650	40–50 % psychiatrischer Schwerpunkt
Forschungslabore von Pharmaunternehmen	350	25–35 % psychiatrische Forschung
Unabhängige Forschungsinstitute	250	20–30 % psychiatrische Forschung

Cingulate Inc. (CING) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Cingulate Inc. Forschungs- und Entwicklungskosten in Höhe von 13,1 Millionen US-Dollar, was eine bedeutende Investition in pharmazeutische Innovationen darstellt.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz der Gesamtausgaben
2022	11,4 Millionen US-Dollar	62.3%
2023	13,1 Millionen US-Dollar	65.7%

Investitionen in klinische Studien

Die Ausgaben für klinische Studien für Cingulate Inc. beliefen sich im Jahr 2023 auf rund 8,5 Millionen US-Dollar und konzentrierten sich auf die Entwicklung fortschrittlicher neurologischer Behandlungen.

• Phase-I-Studien: 3,2 Millionen US-Dollar
• Phase-II-Studien: 4,6 Millionen US-Dollar
• Präklinische Forschung: 0,7 Millionen US-Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften für 2023 wurden auf 2,3 Millionen US-Dollar geschätzt und decken FDA-Anträge und laufende behördliche Anforderungen ab.

Compliance-Kategorie	Kosten
FDA-Einreichungsgebühren	1,1 Millionen US-Dollar
Qualitätssicherung	0,7 Millionen US-Dollar
Regulatorische Dokumentation	0,5 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf 0,9 Millionen US-Dollar und deckten Patentanmeldungen, Erneuerungen und Schutzstrategien ab.

• Patentanmeldungsgebühren: 0,4 Millionen US-Dollar
• Kosten für die Erneuerung des Patents: 0,3 Millionen US-Dollar
• Rechtsschutz: 0,2 Millionen US-Dollar

Personal- und Fachkräfterekrutierung

Die gesamten Personalkosten beliefen sich im Jahr 2023 auf 7,2 Millionen US-Dollar, wobei der Schwerpunkt auf der Rekrutierung spezialisierter neurologischer und pharmazeutischer Talente lag.

Personalkategorie	Anzahl der Mitarbeiter	Gesamtvergütung
Forschungswissenschaftler	35	3,5 Millionen Dollar
Klinische Forscher	25	2,4 Millionen US-Dollar
Verwaltungspersonal	15	1,3 Millionen US-Dollar

Cingulate Inc. (CING) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Bis zum vierten Quartal 2023 verfügt Cingulate Inc. über keine bestätigten Arzneimittellizenzvereinbarungen, die im Jahresabschluss ausgewiesen sind.

Finanzierung klinischer Studien

Klinische Studie	Finanzierungsquelle	Betrag	Jahr
CTx-1812 ADHS-Studie	Interne Investition	3,2 Millionen US-Dollar	2023
CTx-1812 OCD-Studie	Firmenreserven	2,8 Millionen US-Dollar	2023

Forschungsstipendien

In den Finanzberichten 2023 wurden keine konkreten Forschungszuschussbeträge öffentlich bekannt gegeben.

Vertrieb pharmazeutischer Produkte

Bis zum vierten Quartal 2023 hat Cingulate Inc. noch keine Umsätze mit pharmazeutischen Produkten generiert.

Verbundforschungspartnerschaften

• Im Jahr 2023 wurden keine bestätigten Forschungskooperationen gemeldet
• Gesamtausgaben für Forschung und Entwicklung: 12,4 Millionen US-Dollar für das Geschäftsjahr 2023

Gesamtumsatz für das Geschäftsjahr 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.