Overview

• Cingulate Q3 net loss of $7.3 mln missed analyst expectations

• R&D expenses rose 99.5% due to NDA submission costs for CTx-1301

• FDA accepted NDA for CTx-1301 with PDUFA date of May 2026

Outlook

• Company anticipates needing $7 mln additional capital before May 2026 PDUFA date

• Cingulate plans potential commercialization of CTx-1301 in 2026

• Cingulate has commercial supply agreement with Bend Bio Sciences for CTx-1301

Result Drivers

• R&D EXPENSES - Increased due to NDA submission costs for CTx-1301 and preparation for manufacturing validation batches

• G&A EXPENSES - Rise attributed to personnel costs and commercial preparation for CTx-1301 launch

Key Details

Analyst Coverage

• The current average analyst rating on the shares is "buy" and the breakdown of recommendations is 3 "strong buy" or "buy", no "hold" and no "sell" or "strong sell"

• The average consensus recommendation for the biotechnology & medical research peer group is "buy"

• Wall Street's median 12-month price target for Cingulate Inc is $20.00, about 81% above its November 12 closing price of $3.80

Press Release: ID:nGNX2Hpmpt

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(This story was created using Reuters automation and AI based on LSEG and company data. It was checked and edited by a Reuters journalist prior to publication.)