By John Vandermosten, CFA

NYSE:CING

READ THE FULL CING RESEARCH REPORT

Cingulate, Inc. (NASDAQ:CING) reported third quarter results on November 7^th, 2024. No revenues were reported and operating expense of $3.3 million was recognized. During the third quarter and to date the company was issued a European patent for tripulse stimulant formulations, participated in multiple business media interviews and started its final study for CTx-1301 required for the new drug application (NDA). The NDA is expected to be submitted in mid-2025. Cingulate was also able to raise additional capital through its At-the-Market (ATM) facility and other arrangements, increasing its end of quarter cash balance to over $10 million.

Third Quarter Financial and Operational Results 

Cingulate reported third quarter 2024 results in a press release and Form 10-Q filing with the SEC on November 7^th. For the quarter ending September 30, 2024 operating expenses of $3.3 million were recognized. Net loss for 3Q:24 totaled ($3.2) million or ($1.83) per share. For the third quarter of 2024 versus the same prior year period:

• General & Administrative expenses were $1.9 million, up 2% from $1.8 million attributable to increase in legal and professional fees related to the special shareholders meeting, reverse stock split and capital raise. Personnel expenses declined on lower headcount and cost containment measures, including salary reductions for all employees. The annual directors’ and officers’ insurance also declined;
• Research and development expenses fell 64% to $1.4 million from $3.9 million as a result of decreased clinical activity. Prior year period expenses included significant costs related to two Phase III studies for CTx-1301, the fixed dose pediatric and adolescent safety and efficacy study and the pediatric dose optimization and duration study. Enrollment in these two studies was closed in early 2024 and the company will soon wind down the remaining analytical activities required for an NDA submission. Manufacturing and personnel costs decreased due to the reduction in headcount and cost containment measures;
• Net interest and other expense were $50,000 compared to ($229,000) and was related to incurred on outstanding notes payable, offset by interest earned on invested balances;
• Net loss was ($3.2) million vs. ($6.0) million or ($1.83) per share in 3Q:24.

As of September 30, 2024, cash totaled $10.0 million. This amount compares to the $50,000 cash balance held at the end of 2023. Net cash from financing was $24.4 million. Several financing transactions took place this year to generate these cash proceeds. This includes the issuance of common stock related to the ATM Agreement, the Lincoln Park Agreement, the February 2024 Offering and the June 2024 Warrant Inducement. Management anticipates that cash balances are sufficient to support operations until 3Q:25. Following the end of the third quarter, an additional 214,000 shares were sold raising approximately $900,000. 

Launch of Fast/Fed Study 

A fast-fed study must be completed before the NDA can be filed. It will assess the effect of food on the rate and extent of absorption and the overall bioavailability of CTx-1301 at the highest dose of 50 mg by measuring serum drug levels. The trial is expected to cost about $1.4 million. A site has been identified near the company’s headquarters in Kansas City and the trial is expected to begin in the fall enrolling 16 subjects using a crossover design. Cingulate must also complete CTx-1301 product stability analysis for inclusion in the NDA.  

The study is on track to have the last patient completed by the middle of December. Next steps include the database lock, data clean-up and development of the report which should be completed around the end of the first quarter or beginning of the second. This will allow time for a pre-NDA meeting with the FDA and further NDA development which is expected to be filed by July 2025.

Business Media

Cingulate has participated in several business media and investor events in recent months. In June, Cingulate’s CEO Shane Schaffer and ADHD expert Dr. Ann Childress participated in the Benzinga All Live Access Event discussing the unmet needs in ADHD treatment and reviewing the results of the ADHD Phase III fixed dose study evaluating CTx-1301. Dr. Schaffer participated in another Benzinga event in late August where he shared the nesting CTx-1301 tablets, reviewed recently awarded patents and highlighted corporate milestones. Cingulate’s CEO also participated in two episodes of the Big Biz Show sharing details of the ADHD indication that the company is pursuing, recent capital raises and the trials completed and recently started. Links to these interviews, numerous other news clips and company presentations are located on the Events & Presentations page.

Milestones 

• Complete Phase III Clinical Development Plan – 1H:24
• Complete Registration Batches for NDA Filing – 1H:24
• FDA clears CTx-1301 for NDA submission (505(b)(2)) – May 2024
• Issuance of EU patent title Tripulse release stimulant formulations – August 2024
• Launch of CTx-1301 food effect study – September 2024
• NDA Preparation for CTx-1301 – 2H:24
• Registrational stability data – 2H:24
• High dose food effect study, CTx-1301 – 2H:24
• FDA pre-NDA meeting – 1H:25
• File CTx-1301 NDA – July 2025
• Partnership development – 2026

SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. 

DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.