Cingulate Inc. (CING): History, Ownership, Mission, How It Works & Makes Money

Cingulate Inc. (CING) is a name you hear a lot right now in the biopharma space, but do you defintely know why this clinical-stage company, with a market capitalization of just $18.67 million as of late 2025, is poised to disrupt the multi-billion dollar ADHD market? Their proprietary Precision Timed Release™ (PTR™) platform is the real story here, designed to deliver a true once-daily dose for their lead asset, CTx-1301, which targets the approximate $18 billion annual U.S. ADHD market. The FDA's acceptance of their New Drug Application (NDA) in October 2025, setting a May 2026 action date, means this small company is now on the clock for a major commercial transition, even with a Q3 2025 net loss of $7.34 million showing the high cost of development.

Cingulate Inc. (CING) History

You're looking for the origin story of Cingulate Inc., and the core takeaway is this: the company's trajectory is a classic biotech play, moving from a proprietary drug delivery platform to a critical 2025 regulatory sprint that culminated in an accepted New Drug Application (NDA) for their lead asset. This entire evolution hinges on their Precision Timed Release™ (PTR™) technology, which aims to solve the problem of inconsistent symptom control in Attention Deficit Hyperactivity Disorder (ADHD) patients.

The company, a clinical-stage biopharmaceutical firm, has been singularly focused on leveraging its unique platform to create once-daily medications that provide full-day coverage for central nervous system and neurobiological disorders. It's a high-stakes, all-or-nothing path to market.

Given Company's Founding Timeline

Year established

The company was established in 2011, initially as Cingulate Therapeutics LLC, setting the groundwork for its drug delivery-focused pipeline.

Original location

Cingulate Inc. is headquartered in Kansas City, Kansas, a location that has served as its operational base throughout its development phase.

Founding team members

The initial leadership team that established the company included Thomas B. Bridges (Chairman and CEO), Dr. Herbert Allen, and Shane J. Schilroth (COO). Dr. Shane J. Schaffer, who later became Chairman and CEO, is also a co-founder.

Initial capital/funding

Specific details on the initial seed capital are not readily available, but the company's first major public funding event was its Initial Public Offering (IPO) in 2022. That IPO raised $24 million in gross proceeds by offering 6,000,000 shares at $4.00 per share, which was critical to funding the next stages of clinical development.

Given Company's Evolution Milestones

Given Company's Transformative Moments

The real inflection points for Cingulate Inc. all center on validating their core technology and securing the capital to cross the regulatory finish line. Honestly, the entire year 2025 was a transformative sprint.

• The Precision Timed Release™ (PTR™) Platform: This proprietary drug delivery technology is the company's foundation. It's designed to provide a precise, multi-stage release of medication, which directly addresses the major clinical problem of short-acting or inconsistent symptom coverage in ADHD. That's the whole business model.
• The $4.3 million PDUFA Fee Waiver (July 2025): Receiving this waiver from the FDA under the small business provision was a critical financial win, essentially saving the company a significant chunk of capital right before the most expensive phase of pre-commercialization.
• NDA Acceptance and Financing (November 2025): The FDA accepting the NDA for CTx-1301 was immediately followed by a $6.0 million financing transaction via a non-convertible promissory note. This capital injection, coupled with the appointment of a Chief Commercial Officer, Bryan Downey, signals a decisive shift from a purely clinical focus to a commercial launch strategy for a potential mid-2026 market entry.

What this estimate hides is the continued need for capital; as of September 30, 2025, the company reported a net loss of $7.3 million for the quarter, and working capital was down to approximately $1.6 million. The company will defintely need to raise approximately $7.0 million more to advance commercialization through the PDUFA date. You can dive deeper into who's backing this strategy at Exploring Cingulate Inc. (CING) Investor Profile: Who's Buying and Why?

Cingulate Inc. (CING) Ownership Structure

Cingulate Inc. is largely controlled by its individual investors and company insiders, a common structure for a clinical-stage biopharmaceutical company where the founders and early backers hold significant equity. This means strategic decisions are defintely influenced more by the long-term vision of a core group of executives and large individual shareholders than by the quarterly demands of institutional funds.

Cingulate Inc.'s Current Status

Cingulate Inc. is a publicly traded biopharmaceutical company listed on the Nasdaq Stock Market LLC under the ticker symbol CING. Its public status ensures transparency through regular filings with the Securities and Exchange Commission (SEC). The company's market capitalization was approximately $21.27 million as of August 2025. This small-cap status means its stock price can be highly volatile, especially around key regulatory milestones like the New Drug Application (NDA) for its lead asset, CTx-1301, which the FDA accepted in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.

As of the third quarter of 2025, the company reported a net loss of $7.34 million, and its cash and cash equivalents stood at approximately $6.1 million as of September 30, 2025. To advance commercialization efforts, Cingulate secured a $6 million financing transaction in November 2025, extending its cash runway into the second quarter of 2026.

Cingulate Inc.'s Ownership Breakdown

The company's ownership profile is heavily skewed toward individual, non-professional investors, which is typical for a pre-revenue biotech firm. The high insider ownership aligns the interests of the management and board with long-term shareholder value, but it can also limit the stock's trading liquidity.

The largest individual shareholder, Peter J. Werth, holds a significant stake, giving him a powerful voice in the company's direction. For a deeper dive into the company's foundational principles, you can review its Mission Statement, Vision, & Core Values of Cingulate Inc. (CING).

Cingulate Inc.'s Leadership

The company is steered by a lean executive team focused on commercializing its lead drug candidate, CTx-1301, for Attention-Deficit/Hyperactivity Disorder (ADHD). The leadership underwent a significant change in August 2025, with the former CEO placed on administrative leave. This transition highlights the operational risks in a small-cap biotech.

The current leadership team as of November 2025 includes:

• Jay Roberts: Executive Chairman
• Jennifer Callahan: Interim Chief Executive Officer (CEO) and Chief Financial Officer (CFO)
• Bryan Downey: Chief Commercial Officer (appointed in November 2025 to lead launch preparation)
• Raul Silva: Executive Vice President and Chief Scientific Officer (CSO)

The appointment of a Chief Commercial Officer, Bryan Downey, in November 2025 signals a clear shift from a purely R&D focus to commercial readiness, a critical step as the company awaits the FDA decision on CTx-1301. His 25 years of experience in commercial strategy is a key asset right now.

Cingulate Inc. (CING) Mission and Values

Cingulate Inc.'s core purpose is to revolutionize drug delivery for central nervous system disorders, focusing on improving patient adherence and outcomes through precise, once-daily dosing. This mission is grounded in solving the real-world problem of burdensome daily regimens that lead to suboptimal treatment.

Cingulate Inc.'s Core Purpose

The company's cultural DNA is built around a clear, patient-centric mandate: develop next-generation pharmaceutical products that directly address the limitations of existing therapies. Honestly, this is about more than just a new pill; it's about giving patients a full, active day without the dosing anxiety.

Official Mission Statement

Cingulate Inc. is a biopharmaceutical company utilizing its proprietary Precision Timed Release (PTR) drug delivery platform technology to build and advance a pipeline of products designed to improve the lives of patients suffering from frequently diagnosed conditions. This includes an initial focus on Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders.

• Improve lives by solving suboptimal treatment outcomes.
• Eliminate burdensome daily dosing regimens.
• Focus initial efforts on the ADHD and anxiety markets.

To be fair, this mission is backed by tangible financial progress, like the $4.3 million Prescription Drug User Fee Act (PDUFA) fee waiver Cingulate received in fiscal year 2025, which defintely helps conserve capital for development.

Vision Statement

The vision is to establish the Precision Timed Release (PTR) platform as the standard for central nervous system (CNS) and neurobiological disorder treatments where multiple, precise drug releases are needed from a single, convenient dose. They want to expand the pipeline beyond ADHD and anxiety, identifying additional therapeutic areas where the technology can offer significant improvement over current therapies.

• Achieve true once-daily dosing for complex drug regimens.
• Expand the PTR platform into new therapeutic areas.
• Create long-term value for shareholders through disciplined execution.

Here's the quick math on their near-term focus: as of September 30, 2025, the company had approximately $6.1 million in cash and cash equivalents, and it needs to raise about $7.0 million more to advance commercialization efforts for CTx-1301 through the May 2026 PDUFA date. That's a very clear, near-term capital requirement tied directly to their vision's first commercial product.

Cingulate Inc. Slogan/Tagline

While Cingulate Inc. doesn't use a short, consumer-facing slogan in its corporate communications, its entire identity is built around its core technology, which acts as its defining tagline.

• Precision Timed Release™ (PTR™): The proprietary drug delivery platform.
• True Once-Daily Dosing: The promise of the technology.

The company's net loss for the third quarter of 2025 was $7.3 million, reflecting increased Research & Development expenses of $2.8 million as they pushed their lead product, CTx-1301, toward its New Drug Application (NDA) acceptance in October 2025. This shows an operational focus on execution over abstraction. You can read more about their strategic goals here: Mission Statement, Vision, & Core Values of Cingulate Inc. (CING).

Cingulate Inc. (CING) How It Works

Cingulate Inc. works by engineering existing medications into superior, once-daily treatments using its proprietary Precision Timed Release™ (PTR™) drug delivery platform, aiming to solve long-standing dosing problems in the central nervous system (CNS) space.

The company is a clinical-stage biopharmaceutical firm, meaning its value creation right now is focused on advancing its pipeline through regulatory milestones and preparing for a potential commercial launch, not on generating product revenue yet. As of the third quarter of 2025, Cingulate reported a net loss of approximately $7.34 million, which is typical for a company at this development stage, but they did secure a significant fiscal year 2025 PDUFA fee waiver from the FDA, saving about $4.3 million.

Given Company's Product/Service Portfolio

Cingulate's portfolio is built entirely on the promise of its PTR™ platform, which is designed to deliver drug doses at precise, pre-defined intervals throughout the day from a single morning tablet. This approach directly addresses the issue of medication 'wear-off' that plagues many existing extended-release products.

Given Company's Operational Framework

The company's operational framework is lean, focused on intellectual property (IP) and regulatory execution, not large-scale manufacturing or sales yet. It's a classic biotech model: develop the core technology, outsource the complex production, and raise capital to fund the path to market. You can read more about their goals here: Mission Statement, Vision, & Core Values of Cingulate Inc. (CING).

• IP-Centric Development: The core value driver is the Precision Timed Release™ (PTR™) platform, which uses a proprietary Erosion Barrier Layer (EBL) licensed from BDD Pharma (known as Oralogik™). This EBL is the secret sauce-it precisely controls when the drug-containing core releases its dose.
• Regulatory Execution: The biggest near-term action was the FDA's acceptance of the New Drug Application (NDA) for CTx-1301 in October 2025 under the 505(b)(2) pathway, which is a faster regulatory route that relies partly on prior findings for the active ingredient. The target action date is May 31, 2026.
• Outsourced Manufacturing: Cingulate is not building factories. They executed a commercial supply agreement with Bend Bio Sciences in September 2025, making Bend Bio Sciences the exclusive commercial manufacturer for CTx-1301 in the U.S. through 2028, if the drug is approved.
• Commercial Build-Out: In November 2025, the company appointed an industry veteran as Chief Commercial Officer and completed a $6 million financing round to strengthen the balance sheet and fund pre-commercial activities.

Here's the quick math: as of September 30, 2025, Cingulate had about $6.1 million in cash, but they estimate they need to raise approximately $7.0 million more to advance commercialization through the May 2026 PDUFA date. This is a crucial risk to watch.

Given Company's Strategic Advantages

Cingulate's advantages are all rooted in its ability to solve a patient problem that has persisted for decades in the ADHD and anxiety markets-inconsistent, short-acting medication effects. This is defintely a high-value proposition for both patients and prescribers.

• Differentiated Drug Delivery: The PTR™ platform is designed to provide a rapid onset of effect followed by a second and third release, mimicking the benefits of taking multiple immediate-release doses without the compliance headache of multiple pills. This is a significant improvement over existing extended-release formulations that often 'wear off' too early.
• Targeting Unmet Needs: By aiming for an entire active-day duration and eliminating the need for a 'booster' dose, Cingulate directly targets the primary complaints of patients and parents using current ADHD stimulants.
• Regulatory Efficiency (505(b)(2)): Using the 505(b)(2) pathway for CTx-1301 allows Cingulate to potentially get to market faster and with fewer clinical trials than a completely new drug, saving time and money.
• IP Protection: The company holds patents for CTx-1301 in key international markets, including up to 30 European territories, which secures future global market opportunities beyond the U.S.

Cingulate Inc. (CING) How It Makes Money

Cingulate Inc. is a clinical-stage biopharmaceutical company, so it currently generates no revenue from product sales. The company's financial model is centered on securing capital through financing activities and grants to fund the research, development, and regulatory approval of its drug pipeline, primarily the lead candidate CTx-1301 for Attention-Deficit/Hyperactivity Disorder (ADHD).

Cingulate Inc.'s Revenue Breakdown

As of the 2025 fiscal year, Cingulate Inc.'s primary financial inflows are not from commercial sales but from capital-raising activities and cost-saving measures, which are essential to sustain its operations until a product launch, currently projected for mid-2026. The table below reflects the most significant non-product-related financial inflows and cost offsets reported in 2025.

Business Economics

The economics of Cingulate Inc. are typical of a late-stage biopharma company: high capital expenditure with zero product revenue, anticipating a massive payoff upon regulatory approval and commercial launch. This is a high-risk, high-reward model. The entire business hinges on the success of its proprietary Precision Timed Release (PTR) drug delivery platform, which aims to create a superior, once-daily version of established medications like dexmethylphenidate (CTx-1301).

• Cash Burn is High: The company's net loss for the third quarter of 2025 was $7.3 million, a significant jump from $4.1 million in the same period a year ago. This is the cost of doing business in this industry.
• R&D Acceleration: Research and development expenses for Q3 2025 were $2.8 million, nearly doubling with a 99.5% increase year-over-year, as the company ramped up manufacturing and regulatory preparation for its New Drug Application (NDA) submission.
• Commercial Prep Costs: General and administrative (G&A) expenses also surged by 69.7% to $3.1 million in Q3 2025, driven by hiring a Chief Commercial Officer and incurring costs to prepare for a potential mid-2026 launch.
• Cost Savings Win: The $4.3 million Prescription Drug User Fee Act (PDUFA) fee waiver granted by the FDA in fiscal year 2025 was a crucial, non-recurring cost avoidance that directly extended the cash runway.

The core economic engine will shift from capital raising to product sales only after the FDA's May 31, 2026 PDUFA date for CTx-1301, assuming a positive outcome. Right now, the company is burning cash to build a future revenue stream.

Cingulate Inc.'s Financial Performance

As of September 30, 2025, Cingulate Inc.'s financial position reflects a company fully invested in its transition to a commercial-stage entity, but it is defintely capital-constrained. The market capitalization is relatively small at approximately $21.3 million, which highlights the high-risk nature of its current stage.

• Cash Position: Cash and cash equivalents stood at $6.1 million as of September 30, 2025. This is a $6.1 million decrease from the start of the year.
• Working Capital: Working capital was tight at about $1.6 million at the end of Q3 2025, down sharply from $7.7 million at the end of 2024.
• Capital Need: Management projects the current cash will fund operations into the second quarter of 2026, but they must raise an additional $7.0 million to fully advance commercialization efforts through the PDUFA date.
• Recent Financing: In November 2025, the company secured a $6.0 million financing note, which is a necessary, albeit debt-based, bridge to the next major milestone.

This financial picture means the next few quarters are critical, as the company needs to raise capital while maintaining operational focus. For a deeper dive into the balance sheet dynamics, check out Breaking Down Cingulate Inc. (CING) Financial Health: Key Insights for Investors.

Cingulate Inc. (CING) Market Position & Future Outlook

Cingulate Inc. is a pre-commercial biopharmaceutical company whose future hinges entirely on the regulatory approval and subsequent commercial launch of its lead asset, CTx-1301, for Attention-Deficit/Hyperactivity Disorder (ADHD). The company is currently positioned at a critical inflection point, having received FDA acceptance of its New Drug Application (NDA) in October 2025, which sets a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.

This means the next six months are defintely a high-stakes waiting game, as the company transitions from a pure research and development (R&D) focus to commercial readiness, backed by a recent $6.0 million financing and the appointment of a Chief Commercial Officer in November 2025.

Competitive Landscape

Cingulate's core competitive edge is its proprietary Precision Timed Release (PTR) drug delivery platform, which enables a once-daily, multi-core tablet designed to offer rapid onset and entire active-day symptom control-a major differentiator in a market plagued by dosing issues.

The overall U.S. ADHD market is massive, valued at an estimated $10.71 billion in 2025, but it is dominated by a few large pharmaceutical companies and increasingly fragmented by generic competition.

Opportunities & Challenges

The ADHD market presents a clear opportunity for a superior formulation, but Cingulate must navigate the significant financial and regulatory hurdles of a small-cap biotech. The company's net loss for the third quarter of 2025 was $7.3 million, underscoring its capital-intensive position.

Industry Position

Cingulate is a classic development-stage biopharma, valued primarily on its intellectual property-the Precision Timed Release (PTR) platform-rather than current revenue, as its trailing twelve-month revenue is negligible.

• Platform-Driven Value: The PTR technology is the core asset, promising a true once-daily dosing regimen that addresses the 'mid-day crash' common with older extended-release stimulants.
• High Analyst Confidence: Despite the pre-revenue status, analysts have a 'Moderate Buy' consensus rating on the stock, with an average 12-month price target of $27.75, suggesting a significant potential upside based on CTx-1301 approval.
• Commercial Readiness: The execution of a commercial supply agreement with Bend Bio Sciences and the hiring of a Chief Commercial Officer demonstrate a clear, near-term focus on market entry, pending the May 2026 FDA decision.

The company's future position will be defined by its ability to execute on its commercial strategy and secure the necessary capital to bridge the gap until potential product launch. For a deeper dive into the company's foundational strategy, review its Mission Statement, Vision, & Core Values of Cingulate Inc. (CING).