Want to stay updated on the latest mining news?

By John Vandermosten, CFA

NASDAQ:CING

READ THE FULL CING RESEARCH REPORT

Cingulate, Inc. (NASDAQ:CING) reported third quarter 2025 results on November 13^th, 2025. No revenues were recorded and operating expense totaled $6.0 million. The new drug application (NDA) to the FDA was accepted and a PDUFA date of May 31^st, 2026 was given. Cingulate also saw changes in its management ranks as the company’s focus shifts to pre-commercialization activities which included the appointment of Bryan Downey as Chief Commercial Officer. Company representatives have participated in investor and medical conferences, highlighted by Dr. Ann Childress’ podium presentation at AACAP and attendance at the Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) conference. In the financing sphere, a purchase agreement was signed with Lincoln Park Capital, which is expected to augment the in place at-the-market (ATM) facility and support the crescendo of activities leading up to the anticipated approval next year.

3Q:25 Financial and Operational Results

Cingulate reported third quarter results in a press release and Form 10-Q filing with the SEC on November 13^th. For the quarter ending September 30^th, 2025, the company reported a net loss of ($7.3) million or ($1.359) per share. For 3Q:25 versus the same prior year period:

• Research and development expenses were $2.8 million, nearly doubling from $1.4 million. The change was attributable to an increase in personnel expenses, manufacturing costs and regulatory costs. Personnel costs were further broken down into separation costs for an executive recognized in August 2025 and the payment of a contingent bonus plan that were payable upon acceptance of the NDA by the FDA. Manufacturing costs were related to preparation for product validation batches of CTx-1301. Regulatory costs were up as the team prepared to submit the NDA;
• General & administrative expenses rose 70% to $3.1 million from $1.9 million on account of increased personnel and other expenses, higher costs related to the arrangement with Indegene and personnel expenses related to the contingent bonus plan earned upon FDA acceptance of the NDA;
• Net interest and other expense were ($1.3) million compared to ($844,000) related to derivative change in fair value issued to Lincoln Park and its share purchase commitment and interest expense incurred on the promissory note;
• Net loss was ($7.3) million vs. ($4.1) million or ($1.35) and ($3.60) per share respectively.

As of September 30^th, 2025, cash totaled $6.1 million. This amount compares to the $12.2 million cash balance held at the end of 2024. Cash burn was ($13.7) million for the first nine months of 2025, partially offset by $7.6 million in financing cash contributions from the ATM Agreement with H.C. Wainwright and the Lincoln Park Purchase Agreement. After quarter end, Cingulate issued additional shares through the ATM and Purchase Agreement to raise additional capital. It also exchanged shares to repay $850,000 in principal of the existing promissory note. A new promissory note with a face value of $6.57 million was issued in November to support near-term financing needs as Cingulate looks at multiple sources of capital as it prepares for commercialization. Management estimates that the company will need approximately $7 million in additional capital to support operations until the anticipated approval of CTx-1301.

Dr. Ann Childress AACAP Podium Presentation

Data from the CTx-1301 trials were presented at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in Chicago on October 24^th, 2025. Dr. Ann Childress, President of the Center for Psychiatry and Behavioral Medicine and principal investigator on the CTx-1301 trials, gave the presentation. The data was generated in a randomized, double-blind, pediatric and adolescent, placebo-controlled study.

The data showed that CTx-1301 produced a rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported. Dr. Childress, quoted in the press release, said: “In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated the largest effect size in symptom reduction and effect sizes were pretty substantial, considering this was a forced dose and not a dose optimization study. The safety profile did not show anything that would be of concern, as it looks like other methylphenidates.”

In our view, the selection of CTx-1301 for a podium presentation reflects increasing recognition of the product’s potential to address unmet needs in ADHD. The timed delivery of three doses throughout the day recognizes the half-life limitations of dexmethylphenidate and the needs of ADHD patients which extend from morning to evening, but not beyond. We further see this recognition as an indication of broad interest among providers that prescribe the drug.

To watch other videos in this series with Dr. Childress, click the links below.

CTx-1301 FDA Submission Timeline

On August 6^th, Cingulate announced that it had submitted its NDA to the FDA for CTx-1301. On October 14^th, it announced that the NDA had been accepted and a PDUFA date of May 31^st, 2026 was assigned.

Assuming that CTx-1301 is approved, commercialization could start as soon as next year. Cingulate will work with Indegene^[1] to commercialize the product in the United States and 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 Changes

On August 15^th, Cingulate provided a management update informing investors of the appointment of CFO Jennifer Callahan as interim CEO and board member Jay Roberts as Executive Chairman. Shane Schaffer was placed on administrative leave in connection with ongoing legal matters unrelated to the company and its operations. While any change in management calls for a review of the team, the heavy lifting for the next year has been accomplished with the successful submission of the NDA for CTx-1301. We expect the team to begin a measured ramp of pre-commercialization activities.

In November, Cingulate announced that it had named Bryan Downey as Chief Commercial Officer. Mr. Downey has more than 25 years of experience in commercial strategy, leadership, and business transformation, including pharmaceutical product launches. Most recently, he has served as Managing Director at CRA’s advisory practice. Previously, he held senior executive roles at Alfasigma USA and Jubilant Pharma, leading commercial operations and product commercialization efforts. Bryan also spent nearly two decades at Sanofi, where he served as Vice President and Head of the U.S. Cardiovascular and Allergy Business Unit where he oversaw multiple product launches and brand strategies across diverse therapeutic areas.

Bryan began his role with long “To Do” list. He is working on pricing reimbursement and market access, scientific publications and awareness and building out the omnichannel. He will also be working with key account managers to evaluate options for contracting.

Objectives Over the Next Twelve Months

With the submission of CTx-1301 now complete, and acceptance granted in October, we now look ahead to the PDUFA date in May 2026. In parallel with the regulatory process, Cingulate management and related parties will participate in investor and medical conferences to communicate the value of its product. CEO Jennifer Callahan, Vice President of Corporate Communications Thomas Dalton and co-founders Dr. Matthew Brams and Dr. Raul Silva are all participating in the messaging effort on behalf of the company. A key opinion leader in the attention-deficit/hyperactivity disorder (ADHD) space and advisor for Cingulate, Dr. Ann Childress, will also present at medical conferences over the next several months. This includes the American Academy of Child and Adolescent Psychiatry (AACAP) conference in October where she will be presenting on behalf of the company.

Pre-commercialization activities have also moved to the forefront. Cingulate has announced its non-binding arrangement with Indegene to commercialize CTx-1301 in the United States on a fee for service basis. In preparation, management is now conducting market access research to better understand how its time release version of dexmethylphenidate can be successfully adopted, reimbursed, and used by patients. The company will also soon sign its commercial supply agreement and begin the manufacturing of process validation batches. The resulting drug product will be saleable and can be used to fulfill pre-launch inventory.

Milestones

• High dose food effect study, CTx-1301 completed – January 2025
• DCAT Association Meeting in New York – March 2025
• Final data from CTx-1301 fast-fed study – April 2025
• FDA pre-NDA meeting – April 2^nd, 2025
• Written notes from pre-NDA meeting – May 2025
• CTx-1301 NDA submitted to FDA – July 31^st, 2025
• Jennifer Callahan appointed as interim CEO – August 2025
• Jay Roberts appointed as executive chairman – August 2025
• Bryan Downey appointed as Chief Commercial Officer – November 2025
• Participation in the CHADD conference in Kansas City – November 2025
• Completion of $6 million financing – November 2025
• CTx-1301 PDUFA Date – May 31^st, 2026
• Partnership development – 2025/2026

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 payments totaling a maximum fee of up to $50,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.