Cingulate Inc. (CING:NASDAQ), a biopharmaceutical company utilizing its proprietary Precision Timed Release (PTR) platform, has released Phase 3 safety data for its lead asset, CTx-1301, a dexmethylphenidate-based treatment for Attention Deficit Hyperactivity Disorder (ADHD). The latest data set includes findings from two pediatric and adolescent clinical trials — a fixed-dose study and a dose optimization study — as well as a food effect study conducted in healthy adults using a single 50 mg dose, the highest available dosage of CTx-1301.
According to the company, safety results from these studies have been submitted to the U.S. Food and Drug Administration (FDA) in advance of a scheduled in-person Pre-New Drug Application (NDA) meeting on April 2, 2025. A final analysis incorporating adult and pediatric safety and efficacy data is expected to be included in the NDA submission, which remains on target for mid-2025.
Cingulate CEO Shane J. Schaffer stated in the company's news release, "The safety data from these three studies has been reviewed thoroughly, and we are pleased that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials. As we look to bring to the market the first, true, once-daily stimulant medication that treats ADHD over the entire active day, we look forward to our in-person meeting with the FDA next month."
Key findings from the Phase 3 trials indicate that no subjects experienced a serious treatment-emergent adverse event (TEAE), and no TEAEs led to death or serious clinical concerns. The company reported no clinically relevant trends in adverse events overall. The pharmacokinetic analysis of the food effect study is ongoing; however, preliminary medical findings are consistent with prior studies using a 25 mg dose, which suggested that CTx-1301 can be taken with or without food.
ADHD expert Dr. Ann C. Childress, a psychiatrist and former president of the American Professional Society of ADHD and Related Disorders (APSARD), commented on the clinical impact of the findings, stating, "While we have many approved stimulant medications at our disposal as clinicians, booster doses in the morning and/or afternoon are still needed, and these may lead to issues with adherence, efficacy, side effects such as crash and rebound, as well as the potential for abuse and diversion of these short-acting stimulant medications. Having first-hand experience with Cingulate's CTx-1301 product, I am excited for both patients and providers to have this treatment option once approved by the FDA to overcome the longstanding unmet needs facing our patients with ADHD."
ADHD affects approximately 17 million individuals in the U.S., including 11 million adults and 6 million children and adolescents, with the total U.S. ADHD market estimated to be valued at more than US$20 billion. Stimulant medications, which include dexmethylphenidate and amphetamine-based treatments, account for approximately 90% of ADHD prescriptions. Cingulate's PTR technology aims to deliver a true once-daily dosing solution, differentiating it from existing treatments that often require booster doses.
Expanding CNS and Neurology Markets Driven by Rising Demand and Innovation
A February report from Polaris Market Research highlighted that the central nervous system (CNS) therapeutics market was valued at US$141.09 billion in 2024 and was projected to reach US$381.27 billion by 2034, reflecting a compound annual growth rate (CAGR) of 10.5%. The study identified a rising prevalence of depression, anxiety, and Alzheimer's disease as key drivers of demand for CNS treatments. "The growing existence of CNS disorders worldwide is a prominent factor driving the central nervous system therapeutics market," the report stated.
In a March 4 report from Roth Capital Partners, Cingulate, Inc. received a "Buy" rating with a 12-month price target of US$12.00.
The study found that public sector funding had historically provided foundational insights for over three-quarters of transformative drugs developed between 1965 and 1992. It also noted that every US$1 of National Institutes of Health (NIH) funding generated US$1.70 in bioscience industry output. However, the report cautioned that reductions in federal research funding could slow innovation, stating, "At a time when the United States is scaling back its life sciences funding, China is expanding its federal investment in this sector to advance its vision of becoming a global biotechnology superpower."
On March 3, Research and Markets released a report detailing the continued expansion of the neurology sector, with the overall market valued at US$67.3 billion in 2024 and projected to reach US$94.8 billion by 2029. The study cited an increasing incidence of neurological diseases, the development of new treatment modalities, and expanded healthcare infrastructure in emerging markets as major factors contributing to market growth. The report also highlighted that the psychotic disorder treatment segment generated US$14.3 billion in revenue in 2023, with an expected CAGR of 9.5%.
Roth Capital Sees Strong Growth Potential for Cingulate Amid Positive Regulatory and Market Outlook
In a March 4 report from Roth Capital Partners, Cingulate, Inc. received a "Buy" rating with a 12-month price target of US$12.00. The report highlighted the continued positive safety profile of CTx-1301, Cingulate's lead candidate for treating Attention Deficit Hyperactivity Disorder (ADHD). New safety data from both healthy volunteers and pediatric and adolescent patients showed consistency with prior findings, reinforcing confidence in the treatment's potential. Roth Capital noted that the company had scheduled a pre-NDA (New Drug Application) meeting with the FDA for April 2, 2025, to finalize the content and format of its planned submission. The report emphasized that a positive outcome from this meeting would further solidify confidence in the company's regulatory strategy.
Roth Capital underscored CTx-1301's ability to provide full-day ADHD symptom management, a key differentiator in a market where approximately 60% of patients using once-daily ADHD medications still require an additional midday booster dose. The firm projected that CTx-1301 could generate peak sales of US$1.6 billion by 2035. Roth's analysis suggested that the drug's differentiated profile and strong clinical data positioned Cingulate well within the highly competitive ADHD treatment market.
Additionally, the report assessed Cingulate's valuation using a discounted cash flow (DCF) methodology, arriving at an enterprise value of US$24.7 million. Roth Capital acknowledged potential risks such as regulatory setbacks or market penetration challenges but maintained a positive outlook given the product's demonstrated efficacy and the company's ongoing engagement with regulatory authorities.
Cingulate's strong financial position was also noted, with the company reporting US$10 million in cash and marketable securities at the end of Q3 2024. A December 2024 debt financing arrangement secured an additional US$10 million, extending its projected cash runway to Q3 2026. This financial stability was considered a key factor in supporting continued clinical and regulatory progress.
The Roth Capital report concluded that Cingulate's focus on addressing unmet needs in the ADHD market through its proprietary drug delivery technology, combined with the upcoming regulatory milestones, positioned the company for potential long-term success. Given the positive safety data, anticipated NDA submission, and differentiated product profile, Roth Capital reaffirmed its "Buy" rating, citing the company's strong fundamentals and growth potential.
Cingulate Advances Toward NDA Submission While Expanding Pipeline and Strategic Partnerships
Cingulate's investor presentation highlights multiple near-term catalysts supporting its development pipeline. The company remains on track for an NDA submission for CTx-1301 in mid-2025, with a potential FDA approval and commercial launch anticipated in mid-2026. The commercialization strategy includes a partnership with Indegene, designed to provide scalable market readiness upon regulatory approval.
Beyond CTx-1301, Cingulate is also advancing its broader pipeline. The company is preparing an Investigational New Drug (IND) application for CTx-1302, a stimulant-based ADHD treatment using the PTR platform, with a Pre-IND meeting scheduled with the FDA. Additionally, the company is in the early stages of developing CTx-2103, a once-daily formulation of buspirone hydrochloride intended for the treatment of anxiety disorders. Cingulate's PTR platform is being evaluated for potential applications across a range of therapeutic areas, including depression, bipolar disorder, and movement disorders.
Streetwise Ownership Overview*The company is also pursuing licensing agreements outside the U.S. for CTx-1301 and other pipeline assets, with negotiations currently underway. Additionally, Cingulate is exploring out-licensing opportunities for its PTR platform, which could provide additional revenue streams and strategic partnerships. Intellectual property protections remain in place for the PTR platform, with the first loss of exclusivity projected for 2035.
Cingulate's clinical and regulatory timeline for CTx-1301 remains aligned with its previously stated milestones, and the company has expanded its manufacturing operations to support future commercialization efforts. The company expects to provide further updates following the Pre-NDA meeting with the FDA in April 2025.
Ownership and Share Structure
According to Refinitiv, 2.87% of Cingulate is owned by Institutions. Strategic entities hold 3.16%, with Werth Family Investment Associates at 3.05%. Management and Insiders own 0.15%
As of March 5, 2025, Cingulate Inc. has a market cap of approximately US$13.64 million and a public float (free float) of 3.1 million shares. The company reports a 52-week range of US$1.80-US$20.83
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