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Cingulate | 8-K: Current report

SEC announcement ·  Dec 28, 2023 13:00
Summary by Futu AI
On December 26, 2023, Cingulate Inc., a pharmaceutical company, received notification from Nasdaq that it no longer meets the independent director and committee requirements for continued listing, following the resignation of three board members earlier in the month. This issue adds to the previously identified non-compliance with the minimum stockholders' equity rule. Cingulate has requested a hearing with the Nasdaq Hearings Panel, scheduled for February 2024, to present a plan to regain compliance. The company's delisting is stayed pending the hearing outcome. In other updates, Cingulate has received FDA guidance for its lead ADHD treatment candidate, CTx-1301, and plans to submit a New Drug Application in the first half of 2025. The company has halted enrollment in two Phase 3 studies for CTx...Show More
On December 26, 2023, Cingulate Inc., a pharmaceutical company, received notification from Nasdaq that it no longer meets the independent director and committee requirements for continued listing, following the resignation of three board members earlier in the month. This issue adds to the previously identified non-compliance with the minimum stockholders' equity rule. Cingulate has requested a hearing with the Nasdaq Hearings Panel, scheduled for February 2024, to present a plan to regain compliance. The company's delisting is stayed pending the hearing outcome. In other updates, Cingulate has received FDA guidance for its lead ADHD treatment candidate, CTx-1301, and plans to submit a New Drug Application in the first half of 2025. The company has halted enrollment in two Phase 3 studies for CTx-1301 and requires approximately $17-21 million to proceed with the NDA filing. Cingulate also plans to initiate clinical plans for CTx-1302 and is in licensing discussions for CTx-2103. The company acknowledges the need to raise approximately $15 million by March 31, 2024, to comply with Nasdaq's stockholders' equity rule and has regained compliance with the minimum bid price requirement after a reverse stock split.

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