Cingulate, Inc. (NASDAQ:CING) reported 2024 results on March 26th, 2025. No revenues were recorded and operating expense of $15.6 million was recognized. Over the last several months, Cingulate has raised meaningful capital, completed its fast-fed study and reported safety results from its Phase III trials. As we review the checklist for the FDA submission, Cingulate held its pre-new drug application (NDA) meeting last week, continues document preparation and stability analysis and anticipates filing its NDA with the agency by mid-2025. We expect to see further safety data from the consolidated Phase III studies presented at an upcoming but as yet unidentified scientific conference. Lastly, the company received a $3 million grant from a private foundation to advance its preclinical anxiety asset CTx-2103. The funds should be sufficient to support the development of CTx-2103’s investigational new drug (IND) application.
2024 Financial and Operational Results
Cingulate reported 2024 results in a press release and Form 10-K filing with the SEC on March 26th. For the year ending December 31st, 2024, Cingulate reported a net loss of ($15.5) million or ($10.20) per share. For 2024 versus the same prior year period:
General & Administrative expenses were $6.2 million, down 15% from $7.3 million, attributable to lower personnel expenses and insurance. A reduction in headcount and temporary salary decreases were behind the compensation changes. Lower directors’ and officers’ insurance also contributed to the year over year decline. Areas of expense that rose include professional fees, including legal fees related to patent activity, and legal costs associated with special meetings, the reverse stock split and capital raises;
Research and development expenses fell 39% to $9.4 million from $15.5 million as a result of decreased clinical activity and lower manufacturing costs. 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;
Net interest and other expense were $99,000 compared to ($776,000) with prior year amounts related to promissory note’s conversion to equity in 2023;
Net loss was ($15.5) million vs. ($23.5) million or ($10.20) per share in 2024.
As of December 31st, 2024, cash totaled $12.2 million. This amount compares to the $52,000 cash balance held at the end of 2023. Net cash from financing was $30.8 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, the June 2024 Warrant Inducement and the December $5 million financing transaction. So far in 2025, Cingulate raised an additional $1.7 million through its ATM and Lincoln Park Purchase Agreement.
CTx-1301 Next Steps
Cingulate is completing the final requirements for its new drug application (NDA) submission. The company held its pre-NDA meeting with the FDA last week, which will provide final guidance needed to submit an approvable package to the agency. It usually takes about a month for the official meeting minutes to be shared with the sponsor, so we expect Cingulate will receive them by early May. These minutes are important as they document the key discussion points, any agreements reached and the FDA's recommendations. They serve as an official record of the meeting and can be referenced throughout the drug development and approval process. This will provide sufficient time to deliver the package to the FDA by mid-2025. Assuming normal review and approval timelines, commercialization could start as soon as next year. Cingulate has a non-binding arrangement with Indegene[1] to commercialize the product in the United States on a fee for service basis. Cingulate may also pursue a co-promote that would leverage the strengths of multiple parties. Outside the US, Cingulate is looking for partners to commercialize CTx-1301. Beyond international sales, the goal of these relationships is to obtain upfront amounts that will support CTx-1301’s launch in the United States. While the team has not affirmed any specific discussions, we believe that they have had at least initial talks with prospective global partners. Management recently attended the Drug, Chemical & Associated Technologies (DCAT) meeting which yielded a number of further prospects for business development and licensing.
The pathway forward for FDA submission includes several parallel efforts which include updating stability data on 2024 batches of CTx-1301, completing the analysis of the fast fed study and attendance at the pre-NDA meeting with the FDA which was held last week. Notes from the meeting are expected in about a month, which will provide final details required for completing the NDA. NDA submission is expected by mid-2025. We anticipate a 10-to-12-month turnaround time by the agency from initial submission. Upon acceptance of the NDA, the FDA will provide a firm target action date, which we forecast to fall in 2Q:26 or mid-2026.
$3 Million Grant for Development of CTx-2103
An unnamed private foundation awarded a $3 million grant to Cingulate to develop its preclinical anxiety candidate CTx-2103. The grant will be disbursed in three tranches of $1 million with the first cash flow to be paid on May 1st. The second and third tranches will be paid on achievement of specified milestones. If commercially successful, Cingulate will owe a royalty to the foundation that will begin six months after commercialization begins. Payments of $500,000 per quarter will be made, until the maximum cumulative royalty of $3.5 million is reached.
The award is valuable to Cingulate not only for the funding that it provides but also as a validation of the Precision Timed Release (PTR) platform. Based on the support provided by this award, the attractiveness of the asset and its anticipated regulatory pathway, we believe that CTx-2103 will take the baton from CTx-1301 providing Cingulate with its follow-on development candidate.
Safety Results Submitted to FDA
Safety results from Cingulate’s Phase III studies were submitted to the FDA in preparation for the upcoming pre-NDA meeting which is scheduled for April 2nd, 2025. A March 4th press release shared safety data from two Phase III pediatric and adolescent studies. This included a fixed dose study, a dose optimization study, a food effect study with healthy adults, using a single 50mg dose of CTx-1301. While some of the data from the food effect study are still being analyzed, broadly speaking, data from the studies revealed:
No subjects experienced a serious treatment emergent adverse event (TEAE), a serious TEAE or a TEAE leading to death;
There were no clinically relevant trends in TEAEs overall;
Medical findings for the 50 mg dose are consistent with the previous study performed with the 25mg dose, which showed that CTx-1301 could be taken with or without food.
Completion of Fast/Fed Study
A fast-fed study is required as part of the NDA submission. This effort was completed and measured 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 study was conducted at a site near the company’s headquarters in Kansas City and enrolled 26 healthy adults using a crossover design. It was designed as an open-label, randomized, single-dose, two-sequence, two-period, in-clinic study. Subjects were randomized into one of two sequences: a fasted state, and a fed state, after a high-fat test meal. Partial data was submitted to the FDA as part of the pre-NDA meeting submission and additional data from the study are expected in 2Q:25.
The primary pharmacokinetic (PK) endpoints as reported in the January 7th press release were:
Maximum concentration (CMAX) during the first 28 hours after dosing;
Total amount of the active pharmaceutical ingredient (API), dexmethylphenidate, in the blood.
In the study, PK endpoints were expressed as the area under the plasma drug concentration-time curve (AUC) from dosing until the time of the last measured concentration (AUC0-last) and over the time from dosing taken to the limit as the end time moves towards infinity (AUC0-∞).
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[1] See our initiation for further details on the Indegene Joint Commercialization Agreement.
