Cingulate Inc. (NASDAQ:CING) is a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products. The company's initial focus is on the treatment of Attention Deficit Hyperactivity Disorder (ADHD), a condition characterized by persistent inattention, hyperactivity, and impulsivity that affects an estimated 11-15% of children and 4-5% of adults.

Business Overview and Company History

Cingulate was founded in 2012 with the goal of developing improved therapeutic options for frequently diagnosed conditions like ADHD. The company's PTR technology was licensed from BDD Pharma Limited in 2018 and allows for the formulation and manufacture of once-daily tablets that can deliver multiple doses of a drug over an extended period, up to 24 hours.

Since its inception, Cingulate has focused on developing two proprietary, first-line stimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), for the treatment of ADHD. These product candidates utilize the company's PTR technology, which is designed to enable the formulation and manufacture of once-daily tablets of multi-dose therapies.

In 2021, Cingulate completed its initial public offering and listed its shares on the Nasdaq Stock Market, providing the company with additional capital to advance the development of its ADHD product candidates. It's important to note that Cingulate has not yet generated any revenue, as its product candidates are still in clinical development and have not received regulatory approval.

Throughout its history, Cingulate has faced several challenges in advancing its pipeline. The company has incurred significant operating losses as it has worked to develop its product candidates and build out its operations. Cingulate has also had to navigate the complex regulatory landscape, requiring interactions with the U.S. Food and Drug Administration (FDA) to align on the clinical development plans for its product candidates.

Despite these challenges, Cingulate has made progress in its efforts. The company was issued a European patent for its lead asset, CTx-1301, in August 2024, covering up to 30 European territories including the United Kingdom. Cingulate has also completed various clinical studies for CTx-1301, including Phase 3 trials in pediatric and adolescent patients.

Lead Product Candidate CTx-1301

Cingulate's lead product candidate, CTx-1301 (dexmethylphenidate), is designed to provide a rapid onset and last the entire active day with a controlled descent of plasma drug level. This profile aims to address the unmet needs of ADHD patients who often require mid-day booster doses of immediate-release stimulants to maintain symptom control. The company initiated two Phase 3 clinical studies for CTx-1301 in the third quarter of 2023 - a fixed dose pediatric and adolescent safety and efficacy study, and a pediatric dose optimization and duration study. Based on feedback from the FDA, Cingulate closed enrollment on these two Phase 3 trials earlier this year and is now performing the data consolidation and analytical activities required for a New Drug Application (NDA) submission, which is targeted for mid-2025.

Pipeline and Partnerships

In addition to CTx-1301, Cingulate is developing CTx-1302 (dextroamphetamine) as a second ADHD product candidate. The company plans to initiate the clinical development of CTx-1302 pending the availability of additional capital resources. Cingulate is also developing CTx-2103 (buspirone) for the treatment of anxiety. The company has completed a formulation study for CTx-2103, which demonstrated a trimodal release profile providing three precisely timed doses of buspirone. Based on positive results from this study, Cingulate requested and received feedback from the FDA regarding the regulatory pathway and clinical study design for CTx-2103, and believes it can seek approval for this product candidate under the 505(b)(2) pathway.

The company continues to evaluate strategic partnerships to license its ADHD assets, both in the U.S. and internationally. In March 2023, Cingulate entered into a joint commercialization agreement with Indegene, Inc. to potentially utilize their services for the commercialization of CTx-1301 in the United States.

Financial Overview

Cingulate is a pre-revenue, clinical-stage biopharmaceutical company that has funded its operations primarily through the issuance of equity and debt. As of September 30, 2024, the company had cash and cash equivalents of $10 million. However, Cingulate will require additional capital to advance its pipeline, complete regulatory submissions, and potentially commercialize its product candidates.

Financials and Liquidity

For the nine months ended September 30, 2024, Cingulate reported a net loss of $9.41 million, compared to a net loss of $16.60 million for the same period in 2023. Research and development expenses decreased 51.3% year-over-year to $5.12 million, while general and administrative expenses decreased 20.8% to $4.32 million. The company's focus on cost containment and the closure of its Phase 3 pediatric and adolescent ADHD studies contributed to the improved financial performance.

In the most recent quarter (Q3 2024), Cingulate reported a net loss of $3.23 million. The company has not reported any revenue, operating cash flow, or free cash flow in its most recent fiscal year or any previous fiscal years, as it remains in the pre-revenue stage of development.

As of September 30, 2024, Cingulate had $1.54 million in total liabilities and $12.04 million in total stockholders' equity, resulting in a debt/equity ratio of 0.13. The company's current ratio stood at 7.35, while its quick ratio was 7.29, indicating a strong short-term liquidity position.

Cingulate believes its current cash and cash equivalents of $10.04 million will be sufficient to fund operations into the third quarter of 2025 under its current business plan. The company has funded its operations to date through various capital raising activities, including public and private offerings, an at-the-market (ATM) equity program, and an equity line of credit.

Risks and Challenges

As a clinical-stage biopharmaceutical company, Cingulate faces several risks and challenges inherent to the industry. These include the potential for clinical trial failures, regulatory hurdles, competition from other ADHD treatments, and the need to secure additional funding to advance its pipeline. The company's reliance on its PTR technology platform and focus on a single therapeutic area also concentrates its risk profile.

Cingulate's ability to successfully develop, obtain regulatory approval for, and commercialize its product candidates will be critical to its future success. The company's financial position and need for additional capital also pose risks, as an inability to raise funds could delay or halt its development programs.

Conclusion

Cingulate's PTR technology platform has the potential to address significant unmet needs in the ADHD treatment landscape. The company's lead candidate, CTx-1301, is designed to provide a true once-daily dosing regimen with a controlled release profile, which could benefit the majority of ADHD patients currently requiring mid-day booster doses.

While Cingulate faces the typical risks associated with a clinical-stage biopharmaceutical company, its progress in advancing CTx-1301 through late-stage trials and the FDA's clearance to file for marketing approval are encouraging. The company's ability to secure strategic partnerships and additional funding will be crucial as it works towards potential commercialization.

Cingulate is targeting a mid-2025 New Drug Application (NDA) submission for CTx-1301. If approved, the company believes CTx-1301 could benefit over 60% of ADHD patients currently using immediate-release booster doses to maintain symptom control throughout the day. Additionally, the development of CTx-2103 for anxiety treatment expands Cingulate's potential market reach beyond ADHD.

Investors should closely monitor Cingulate's upcoming NDA submission, any further developments related to its pipeline and partnerships, and its ability to secure additional funding to support its ongoing operations and clinical development programs.