Stonegate Capital Partners Updates Coverage on Cingulate Inc. (CING) 2Q25
Cingulate Inc. (NASDAQ: CING) received updated coverage from Stonegate Capital Partners following their Q2 2025 results. The company has made significant progress with its lead ADHD treatment CTx-1301, submitting its New Drug Application (NDA) to the FDA on July 31, 2025. The company expects FDA acceptance in Q4 2025 with a potential PDUFA date in mid-2026.
The company's innovative Precision Timed Release (PTR) platform aims to improve ADHD treatment through true once-daily dosing. Financial position shows $8.9M in cash and $3.5M in working capital, sufficient to fund operations into late 2025. Phase 3 pediatric trial and fed/fast study demonstrated positive results, while commercialization preparations continue with Indegene for a planned mid-2026 launch.
Cingulate Inc. (NASDAQ: CING) ha ottenuto una nuova copertura da Stonegate Capital Partners dopo i risultati del secondo trimestre 2025. L'azienda ha fatto passi avanti con il suo trattamento principale per l'ADHD, CTx-1301, presentando la domanda di New Drug Application (NDA) alla FDA il 31 luglio 2025. Cingulate prevede l'accettazione della domanda nel quarto trimestre 2025 e una possibile data PDUFA a met脿 2026.
La piattaforma proprietaria Precision Timed Release (PTR) 猫 studiata per migliorare la terapia dell'ADHD con una vera somministrazione una volta al giorno. La situazione finanziaria riporta $8,9M di liquidit脿 e $3,5M di capitale circolante, ritenuti sufficienti per finanziare le attivit脿 operative fino alla fine del 2025. Gli studi clinici, incluso il Phase 3 pediatrico e lo studio fed/fast, hanno mostrato risultati positivi, mentre con Indegene proseguono i preparativi per una commercializzazione prevista a met脿 2026.
Cingulate Inc. (NASDAQ: CING) recibi贸 cobertura actualizada de Stonegate Capital Partners tras sus resultados del segundo trimestre de 2025. La compa帽铆a avanz贸 significativamente con su tratamiento principal para el TDAH, CTx-1301, presentando la solicitud de New Drug Application (NDA) a la FDA el 31 de julio de 2025. Espera que la FDA acepte la solicitud en el cuarto trimestre de 2025 y una posible fecha PDUFA a mediados de 2026.
La innovadora plataforma Precision Timed Release (PTR) busca mejorar el tratamiento del TDAH mediante una verdadera dosificaci贸n una vez al d铆a. La posici贸n financiera muestra $8.9M en efectivo y $3.5M en capital de trabajo, suficientes para financiar las operaciones hasta finales de 2025. El ensayo de fase 3 pedi谩trico y el estudio fed/fast arrojaron resultados positivos, y los preparativos de comercializaci贸n contin煤an con Indegene para un lanzamiento previsto a mediados de 2026.
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須岇偓 瓿犾湢鞚� Precision Timed Release (PTR) 頂岆灚韽检潃 頃橂（ 頃� 氩堨潣 歆勳爼頃� 韴暯鞙茧 ADHD 旃橂毳� 臧滌劆頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 鞛 靸來儨電� $8.9M 順勱笀瓿� $3.5M 鞖挫爠鞛愲掣鞚� 氤挫湢頃橁碃 鞛堨柎 2025雲� 毵愱箤歆� 鞖挫榿 鞛愱笀鞚� 於╇嫻頃� 瓴冹溂搿� 氤挫瀰雼堧嫟. 靻岇晞 雽�靸� 3靸侁臣 fed/fast 鞐瓣惮鞐愳劀 旮嶌爼鞝� 瓴瓣臣毳� 頇曥澑頄堨溂氅�, Indegene鞕� 頃粯 2026雲� 欷戨皹 於滌嫓毳� 氇╉憸搿� 靸侅毄頇� 欷�牍勲ゼ 鞚挫柎臧�瓿� 鞛堨姷雼堧嫟.
Cingulate Inc. (NASDAQ: CING) a re莽u une couverture mise 脿 jour de Stonegate Capital Partners apr猫s ses r茅sultats du deuxi猫me trimestre 2025. La soci茅t茅 a r茅alis茅 des progr猫s significatifs avec son traitement principal contre le TDAH, CTx-1301, en soumettant sa demande de New Drug Application (NDA) 脿 la FDA le 31 juillet 2025. Elle s'attend 脿 ce que la FDA accepte la demande au quatri猫me trimestre 2025, avec une date PDUFA possible 脿 la mi-2026.
La plateforme innovante Precision Timed Release (PTR) vise 脿 am茅liorer le traitement du TDAH par une v茅ritable administration une fois par jour. La situation financi猫re affiche $8,9M de tr茅sorerie et $3,5M de fonds de roulement, suffisants pour financer les op茅rations jusqu'脿 fin 2025. L'essai p茅diatrique de phase 3 et l'茅tude fed/fast ont donn茅 des r茅sultats positifs, tandis que les pr茅paratifs de commercialisation se poursuivent avec Indegene en vue d'un lancement pr茅vu 脿 la mi-2026.
Cingulate Inc. (NASDAQ: CING) erhielt nach den Q2-2025-Ergebnissen aktualisierte Coverage von Stonegate Capital Partners. Das Unternehmen hat bei seiner f眉hrenden ADHD-Therapie CTx-1301 erhebliche Fortschritte erzielt und am 31. Juli 2025 den New Drug Application (NDA)-Antrag bei der FDA eingereicht. Man rechnet mit einer Annahme durch die FDA im Q4 2025 und einem m枚glichen PDUFA-Termin Mitte 2026.
Die innovative Precision Timed Release (PTR)-Plattform soll die ADHD-Behandlung durch eine echte einmal t盲gliche Dosierung verbessern. Die finanzielle Lage weist $8,9M an Barmitteln und $3,5M an Working Capital aus, ausreichend zur Finanzierung der Gesch盲ftst盲tigkeit bis Ende 2025. Die Phase-3-Studie bei Kindern und die fed/fast-Studie zeigten positive Ergebnisse, und die Vorbereitungen zur Kommerzialisierung laufen mit Indegene f眉r einen geplanten Start Mitte 2026 weiter.
- Successful submission of NDA for CTx-1301 to FDA
- Positive Phase 3 pediatric trial results
- Strong efficacy and flexible dosing demonstrated in fed/fast study
- $8.9M cash position funding operations into late 2025
- Limited cash runway extending only into late 2025
- Potential need for additional funding before commercial launch in mid-2026
Dallas, Texas--(Newsfile Corp. - August 21, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 2Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301. The Company remains focused on advancing its Precision Timed Release (PTR) platform, designed to address gaps in current ADHD treatments by enabling true once-daily dosing. With a differentiated product profile and a large U.S. market opportunity, management is preparing for commercialization while also evaluating opportunities to broaden its global footprint through strategic partnerships.
To view the full announcement, including downloadable images, bios, and more, .
Key Takeaways:
Cingulate submitted its NDA for CTx-1301 on July 31, 2025, with FDA acceptance expected in 4Q25 and a potential PDUFA date in mid-2026.
CING ended 2Q25 with
$8.9M in cash and$3.5M in working capital, funding operations into late 2025.Positive results from the Phase 3 pediatric trial and fed/fast study reinforced CTx-1301's strong efficacy and flexible dosing, while commercialization planning with Indegene is underway to prepare for a mid-2026 launch.
Click image above to view full announcement.
About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.
Contacts:
Stonegate Capital Partners
(214) 987-4121
[email protected]
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FAQ
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