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Cingulate is a biopharmaceutical company developing advanced, precision timed-release drug formulations for existing medications. Think of them as similar to Supernus Pharmaceuticals (SUPN), which focuses on creating improved extended-release versions of established drugs, but Cingulate leverages a proprietary platform designed for true once-daily dosing with a predictable profile.

Imagine Cingulate as a biotech company with a specialized "Precision Timed Release" drug delivery platform. It's akin to how Alnylam Pharmaceuticals (ALNY) has an RNAi platform, but Cingulate's goal is to dramatically enhance the performance and convenience of existing drug compounds, like ADHD medications, rather than discovering entirely new molecules from scratch.

Cingulate is a pharmaceutical company that aims to "upgrade" the delivery system of established drugs for better patient outcomes. Consider it similar to how Takeda (TAK) developed Vyvanse as a next-generation, long-acting stimulant based on a known compound, but Cingulate achieves this with a versatile, proprietary precision timed-release platform applicable to various medications.

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• CTx-1301 (dexmethylphenidate): A lead investigational drug for Attention-Deficit/Hyperactivity Disorder (ADHD) utilizing Cingulate's Precision Timed Release™ technology.
• CTx-1302 (anagrelide): An investigational drug candidate developed with their Precision Timed Release™ platform for the treatment of anxiety disorders.

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Cingulate (symbol: CING) is a clinical-stage biopharmaceutical company focused on developing drug candidates using its Precision Timed Release™ (PTR™) drug delivery platform. As a company primarily engaged in research and development and conducting clinical trials, Cingulate does not currently have any approved products on the market generating significant sales revenue. Therefore, it does not have "major customers" in the traditional sense of entities purchasing its products.

However, if Cingulate's drug candidates (such as CTx-1301 for ADHD or CTx-001 for anxiety) successfully complete clinical trials and receive regulatory approval, the company would primarily sell its products to other companies involved in the pharmaceutical supply chain. These prospective major customers would typically include:

• Pharmaceutical Distributors: Companies that manage the warehousing and distribution of pharmaceutical products to pharmacies, hospitals, and clinics. Examples of such companies (provided as representative of the category, not confirmed as Cingulate's future partners) include:
  • McKesson Corporation (symbol: MCK)
  • Cardinal Health (symbol: CAH)
  • AmerisourceBergen (symbol: ABC)
• Pharmacies: Both large retail pharmacy chains and hospital pharmacies that dispense prescribed medications to patients. Examples of such companies include:
  • CVS Health (symbol: CVS)
  • Walgreens Boots Alliance (symbol: WBA)
• Hospitals and Healthcare Systems: Large organizations that purchase medications for inpatient and outpatient care, often directly or through distributors.

Ultimately, while these "other companies" would be the direct purchasers from Cingulate (post-approval), the end-users of the medications would be individuals (patients) prescribed the drugs by healthcare professionals.

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• Catalent, Inc. (CTLT)
• Mallinckrodt PLC
• Albemarle Corporation (ALB)

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Jennifer Callahan, Interim Chief Executive Officer and Chief Financial Officer

Jennifer Callahan was appointed Cingulate's Chief Financial Officer in January 2024 and subsequently named Interim Chief Executive Officer in August 2025. She brings decades of finance and accounting experience to the C-Suite, having served as Vice President, Corporate Controller for Cingulate from 2017 until her promotion to CFO. Callahan began her career with Deloitte in various roles within the audit practice. Prior to joining Cingulate, she was the Director of Accounting for a Kansas City area CPA firm and provided consulting services to both publicly and privately owned companies in diverse industries. Ms. Callahan is a Certified Public Accountant (CPA) and holds a BSBA in Accounting and Finance from Creighton University.

Shane J. Schaffer, Co-founder, Chairman (currently on administrative leave)

Shane J. Schaffer is the Co-founder and Chairman of Cingulate Therapeutics, which he established in January 2013, driven by his passion for improving treatments for ADHD and anxiety disorders. He served as the Chief Executive Officer until August 2025, when he was placed on administrative leave due to legal matters unrelated to the company's operations. With a 25-year career in the pharmaceutical industry, he is an expert in drug development and commercialization. Schaffer's entrepreneurial ventures include founding Sabre Scientific Solutions, LLC in July 2009, where he provided strategic consulting services to pharmaceutical and biotechnology companies. Throughout his career, he held managerial positions at Pfizer, Novartis, and Sanofi, where he was instrumental in developing and commercializing several billion-dollar brands. Notably, at Novartis, he successfully launched Ritalin® LA and Focalin™, achieving significant market penetration and earning the Novartis Business Excellence Award.

Matthew Brams, MD, Chief Medical Officer

Dr. Matthew Brams is a Co-Founder of Cingulate Therapeutics and serves as its Chief Medical Officer. He is also the Medical Director and Principal of Bayou City Research, Inc. Dr. Brams has over 25 years of clinical experience in adult and child psychiatry, with particular expertise in ADHD and Autistic Spectrum Disorders. He has been a lead investigator in over 125 clinical trials for adult and pediatric populations across various psychiatric areas, contributing to the FDA approval of more than 15 Central Nervous System drugs. Dr. Brams received his MD from the University of Texas Health Science Center in Houston and completed his residencies at Baylor College of Medicine, where he is also a Clinical Associate Professor.

Raul R. Silva, MD, Chief Science Officer

Dr. Raul R. Silva is a Co-Founder of Cingulate Therapeutics and serves as Chief Science Officer. He is a practicing child and adolescent psychiatrist. Dr. Silva's extensive experience includes serving as Associate Professor and Vice Chairman of Child and Adolescent Psychiatry at New York University School of Medicine, Executive Director of Rockland Children's Psychiatric Center, and Deputy Director in the Division of Child and Adolescent Psychiatry at Bellevue Hospital Center. He has authored or co-authored over 125 publications and served as Principal Investigator or Co-Investigator for 21 research projects. Dr. Silva earned his Doctor of Medicine degree from Ross University and completed a fellowship in child and adolescent psychiatry at Columbia University's St. Luke's/Roosevelt Hospital Center, followed by a psychopharmacology research fellowship at New York University Medical Center.

Nilay Patel, JD, Chief Legal Officer

Nilay Patel serves as Chief Legal Officer of Cingulate Inc., bringing over 20 years of legal, compliance, and operational leadership experience across the pharmaceutical and biotechnology industries. He has extensive experience supporting all stages of pharmaceutical development and commercialization, with a focus on legal strategy, healthcare compliance, intellectual property, and corporate governance. Prior to joining Cingulate, Mr. Patel was Chief Legal Officer, Chief Compliance Officer, and Corporate Secretary at Ironshore Pharmaceuticals. In this role, he played a key part in launching the company's flagship ADHD therapy and led legal and compliance functions through its acquisition by Collegium Pharmaceuticals in a $550 million transaction. He also held senior legal positions at Grifols, where he served as Assistant General Counsel for the U.S. Bioscience division, and at Life Sciences Law PLLC, where he advised emerging biotech and global pharmaceutical clients on licensing, mergers and acquisitions, and intellectual property matters. Mr. Patel holds a Juris Doctor from Columbia Law School and dual Bachelor of Science degrees in Biochemistry and Chemistry from North Carolina State University.

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• Limited Financial Resources and Need for Additional Funding: Cingulate operates with limited cash and cash equivalents, a significant cash burn rate, and is currently unprofitable. The company consistently requires substantial external funding to support its ongoing research and development initiatives, clinical trial expenses, regulatory submissions, and potential commercialization efforts. This continuous need for capital poses a significant challenge to its sustained operations and development.

• Product Development and Regulatory Approval Risk: Cingulate's business success is heavily reliant on the successful development, positive clinical trial outcomes, and ultimate regulatory approval of its narrow product pipeline, primarily CTx-1301 for ADHD and CTx-2103 for anxiety/depression. Any failure in clinical trials to demonstrate safety and efficacy or the inability to obtain necessary regulatory approvals would significantly impact the company's prospects.

• Shareholder Dilution and Market Volatility: The company has a history of shareholder dilution through past equity financings and promissory notes to raise capital, indicating a potential for further dilution as it continues to seek funding. Furthermore, as a small-cap biotechnology company, Cingulate is exposed to the inherent volatility and fluctuations of the biotechnology market.

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• CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine) for ADHD: These product candidates are being developed to serve the U.S. ADHD market. The estimated annual U.S. ADHD market size varies across reports:
  • Approximately $18 billion.
  • Approximately $22.1 billion.
  • More than $20 billion.
  • $10.31 billion in 2024, projected to reach $13.88 billion by 2033 (U.S.).
  • $9.6 billion in 2023, expected to reach $13.6 billion by 2034 (U.S.).
  • Expected to reach $10.2 billion by the end of 2032 (U.S.).
  • The U.S. ADHD market is estimated to be $23 billion.
  The global Attention Deficit Hyperactivity Disorder therapeutics market size is estimated at US$ 25.05 billion in 2024 and is forecasted to reach US$ 45.51 billion by 2034. The U.S. market dominated the global industry with a revenue share of 69.1% in 2023. The U.S. target addressable market for ADHD is estimated to be around 17 million individuals. CTx-1301 alone could generate peak sales of US$1.6 billion by 2035.
• CTx-2103 (buspirone hydrochloride) for Anxiety: This product candidate is being developed to serve the U.S. anxiety market. The estimated market size for anxiety treatment in the U.S. is:
  • Approximately $5 billion.
  • $5.2 billion in 2020.
  • $5.5 billion (U.S. anxiety market), with a global market of $11.6 billion.

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1. Commercial Launch of CTx-1301 for ADHD: Cingulate's primary revenue driver is anticipated to be the successful commercial launch of CTx-1301, its lead asset for Attention Deficit Hyperactivity Disorder (ADHD). The company submitted a New Drug Application (NDA) for CTx-1301 in mid-2025, and the FDA accepted the NDA with a Prescription Drug User Fee Act (PDUFA) date set for May 31, 2026. A commercial launch is projected for mid-2026, following potential FDA approval. Analysts have indicated that CTx-1301, designed as a true once-daily stimulant medication offering full-day ADHD symptom management, could capture a significant share of the ADHD market due to its differentiated profile.
2. Advancement and Potential Commercialization of CTx-2103 for Anxiety: Cingulate is accelerating the development of CTx-2103, a buspirone-based treatment for anxiety disorders, aiming for it to be the first once-daily formulation of this widely prescribed anxiolytic agent. The company received a $3 million grant in April 2025 to fund formulation studies and further development, moving this candidate forward in its pipeline. While earlier in its development cycle compared to CTx-1301, successful progression and potential market entry within the 2-3 year timeframe could contribute to revenue.
3. Out-licensing of the Precision Timed Release (PTR) Platform: Cingulate's proprietary Precision Timed Release (PTR) drug delivery platform technology presents an opportunity for additional revenue streams through out-licensing agreements and strategic partnerships. This platform allows for the precise delivery of multiple releases of active pharmaceutical ingredients in a single tablet, which can be applied to develop new product candidates in various therapeutic areas beyond ADHD and anxiety.

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