Cingulate Inc. (CING): Business Model Canvas [Dec-2025 Updated]

You're looking at Cingulate Inc. right now at a critical inflection point: moving from a clinical-stage company to one that needs to sell a product, which is always a high-stakes pivot. Honestly, as an analyst, I see their entire business model for late 2025 resting on one date: the May 31, 2026 PDUFA date for CTx-1301. With cash on hand around $6.1 million as of September 30, 2025, their success hinges on executing those key partnerships and manufacturing scale-up to nail that mid-2026 launch. Dive into the canvas below to see the precise structure they've built to manage this transition from R&D spend to commercial revenue.

Cingulate Inc. (CING) - Canvas Business Model: Key Partnerships

You're mapping out Cingulate Inc.'s strategic dependencies, which is smart; these partnerships are the backbone supporting their path to commercialization for CTx-1301, especially given their current cash position.

The core of Cingulate Inc.'s manufacturing security rests with Bend Bio Sciences. This is an exclusive U.S. commercial manufacturing agreement for CTx-1301, contingent on FDA approval, running through 2028,. Cingulate Inc. has made a firm commitment here: they will purchase 100% of their overall U.S. commercial supply of CTx-1301 from Bend Bio Sciences, assuming the drug gets the green light,. Remember, the New Drug Application (NDA) for CTx-1301 was submitted on July 31, 2025, with a PDUFA target action date set for May 31, 2026,.

For getting the product to market, the joint commercialization agreement with Indegene is key. This partnership, originally established in March 2023, provides full commercial support using an omnichannel marketing approach,. Indegene's platform is designed to optimize prescriber reach and payer access for the potential launch of CTx-1301. The reliance on this external expertise shows up in the financials; Cingulate Inc.'s General and Administrative Expenses for the third quarter of 2025 were $3.1 million, marking an increase of 69.7% from the prior year period, largely due to commercial costs related to the contract with Indegene. This is a necessary cost to tap into the global ADHD market, which exceeds $23 billion annually.

The technology enabling the differentiated product profile is secured through a licensing deal with BDD Pharma for the OralogiK™ Erosion Barrier Layer technology. This technology is fundamental to both CTx-1301 and the anxiety candidate, CTx-2103,. The original agreement structure included an upfront payment, milestones, and future royalties,.

Financing these operations is heavily reliant on external capital commitments. Cingulate Inc. secured a flexible capital agreement with Lincoln Park Capital Fund, LLC, allowing the firm to purchase up to $25 million of Cingulate Inc.'s common stock over a 36-month period, starting in July 2025,,. This facility provides significant financial flexibility, potentially representing over 1.5 times the company's market value at the time of the announcement. Separately, in November 2025, Cingulate Inc. completed a financing transaction providing net proceeds of $6 million via a non-convertible, unsecured promissory note.

The development pipeline, specifically for CTx-2103 (the anxiety program), also involves external financial and operational support. While specific CRO names for ongoing trials aren't detailed, the financial structure for CTx-2103 development is clear:

The increased focus on R&D across the pipeline is reflected in the Q3 2025 results, where Research and Development Expenses rose by 99.5% year-over-year, driven by personnel, manufacturing, and regulatory costs.

You can see the breadth of these external relationships in the operational support Cingulate Inc. relies on:

• Exclusive U.S. commercial supply of CTx-1301 secured with Bend Bio Sciences through 2028,.
• Omnichannel marketing and commercial support provided by Indegene for CTx-1301,.
• Licensing of the OralogiK™ Erosion Barrier Layer technology from BDD Pharma.
• Up to $25 million in equity capital access via Lincoln Park Capital over 36 months,.
• Recent $6 million financing transaction completed in November 2025.
• Development funding for CTx-2103 supported by a $3 million grant with a $3.5 million maximum royalty obligation.

Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Key Activities

You're preparing to analyze Cingulate Inc.'s operational focus as they stand right before a major potential inflection point-the PDUFA date for their lead asset. Here's the breakdown of the core activities Cingulate Inc. is driving as of late 2025, grounded in their Q3 2025 financial and operational reporting.

Regulatory management of CTx-1301 New Drug Application (NDA) review process

The primary regulatory activity centers on the New Drug Application (NDA) for CTx-1301. Cingulate Inc. submitted this NDA on July 31, 2025. The U.S. Food and Drug Administration (FDA) accepted the NDA for review in October 2025, setting the Prescription Drug User Fee Act (PDUFA) target action date for May 31, 2026. This acceptance was achieved with a significant financial benefit, as Cingulate Inc. received a fiscal year 2025 PDUFA fee waiver from the FDA, saving the Company approximately $4.3 million. The costs associated with this regulatory push are reflected in the operating expenses; Research and Development (R&D) expenses for the third quarter of 2025 reached $2.8 million, representing a year-over-year increase of 99.5%, which included regulatory costs. The entire pathway is now defined by this specific date.

Manufacturing scale-up and supply chain readiness with Bend Bio Sciences

Cingulate Inc. de-risked the supply chain by securing an exclusive commercial manufacturing partnership with Bend Bio Sciences in September 2025. Under this arrangement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, contingent upon FDA approval. Cingulate Inc. has committed to purchasing 100% of its overall U.S. commercial supply from Bend Bio Sciences post-approval. This partnership followed the completion of process transfer and scale-up production utilizing commercial-grade equipment, validating the supply chain readiness ahead of a potential launch.

Pre-commercialization planning, including pricing, reimbursement, and market access (PRMA)

Transitioning to a commercial-stage company required significant investment in pre-launch activities. Cingulate Inc. appointed industry veteran Bryan Downey as Chief Commercial Officer following the third quarter. These commercial preparation costs are captured within the General and Administrative (G&A) expenses, which totaled $3.1 million for the three months ended September 30, 2025, an increase of 69.7% year-over-year. Early payer research has indicated strong formulary receptivity for the once-daily CTx-1301, suggesting alignment with key payer priorities.

Research and development for pipeline assets like CTx-2103 for anxiety

Beyond CTx-1301, Cingulate Inc. continues R&D on its anxiety asset, CTx-2103 (buspirone). This product is targeted at the $5.5 billion US anxiety market, which is valued at $11.6 billion globally. Development is being accelerated by a $3 million grant from a private foundation, paid in three $1 million installments. The grant supports development through mid-2026, the targeted timing for the Investigational New Drug (IND) application for CTx-2103. The foundation receives a contingent royalty of $500,000 per quarter, capped at a cumulative total of $3.5 million. Overall R&D expenses for Q3 2025 were $2.8 million.

Securing additional capital to fund operations past Q2 2026

The current cash position necessitates further financing to bridge the gap to the PDUFA date and initial commercialization. As of September 30, 2025, Cingulate Inc. held approximately $6.1 million in cash and cash equivalents, a $6.1 million decrease from the balance on December 31, 2024. Working Capital also decreased to approximately $1.6 million as of the quarter-end. Management guides that the existing cash satisfies capital needs into the second quarter of 2026 under the current plan. To advance commercialization efforts through the May 31, 2026 PDUFA date, the Company estimates it will need to raise approximately $7.0 million of additional capital. To support near-term operations, Cingulate Inc. completed a post-quarter financing of $6.0 million structured as a non-convertible, unsecured promissory note accruing interest at 9% per annum with an 18-month maturity.

Here's a quick look at the key financial metrics driving this funding need:

Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Key Resources

The core of Cingulate Inc.'s value proposition rests on its Proprietary Precision Timed Release (PTR) drug delivery platform technology. This technology is the engine behind their lead asset, designed to create once-daily tablets for multi-dose therapies, aiming to significantly improve upon existing dosing regimens for conditions like Attention Deficit Hyperactivity Disorder (ADHD).

This platform is protected by intellectual property covering the multi-phase release tablet formulation. This proprietary nature is crucial for maintaining a competitive edge in the pharmaceutical space, especially as they move toward commercialization for their lead candidate.

A defining resource is the regulatory progress made with CTx-1301 (dexmethylphenidate HCl) for ADHD. The U.S. Food and Drug Administration (FDA) confirmed acceptance of the New Drug Application (NDA) for review in early October 2025. The NDA itself was submitted on July 31, 2025. This acceptance sets a firm Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.

Financially, as of the third quarter close, the company's liquidity position is a key resource to manage near-term operations. Here's the quick math on the balance sheet as of September 30, 2025:

The company noted that this cash position, combined with a recent financing transaction, is expected to satisfy capital needs into the second quarter of 2026 under the current business plan. Still, to fully advance commercialization efforts through the PDUFA date, Cingulate Inc. will need to raise approximately $7.0 million of additional capital.

The team executing this strategy is also a critical asset. Cingulate Inc. bolstered its commercial readiness by appointing Bryan Downey as Chief Commercial Officer on November 3, 2025. Downey brings over 25 years of experience in commercial strategy and successful pharmaceutical launches, having held senior executive roles at companies including Alfasigma USA, Jubilant Pharma, and Sanofi.

The key tangible and intangible assets supporting the business model include:

• Proprietary Precision Timed Release (PTR) drug delivery platform technology.
• Accepted NDA for CTx-1301 with a PDUFA date of May 31, 2026.
• Cash and equivalents of $6,118,710 as of September 30, 2025.
• Intellectual property protecting the multi-phase release tablet formulation.
• Experienced commercial leadership team, including the new Chief Commercial Officer, Bryan Downey.

Finance: draft 13-week cash view incorporating the $7.0 million projected capital need by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Value Propositions

You're looking at the core value Cingulate Inc. delivers, which is built entirely around their Precision Timed Release™ (PTR™) technology. This platform is the engine creating the differentiated product profiles for both ADHD and anxiety candidates.

True once-daily dosing for entire active-day symptom control in ADHD

For the lead ADHD asset, CTx-1301 (dexmethylphenidate), the value proposition is delivering symptom control across the entire active day from a single dose. Phase 3 clinical trial results, presented at the AACAP Annual Meeting, demonstrated this capability. Specifically, the 37.5mg dose showed the largest effect size in symptom reduction on the ADHD ratings scale and Clinical Global Impression-Severity scales. Raul Silva, Chief Science Officer, stated that CTx-1301 can deliver reliable symptom control for the entire active-day in one pill. This is achieved by the PTR platform delivering three precisely timed releases of medication throughout the day. The market Cingulate is targeting for its ADHD candidates, including CTx-1301 and CTx-1302, is approximately $18 billion annually in the U.S.

Rapid onset of action with a smooth pharmacokinetic profile

The Phase 3 trial data for CTx-1301 also confirmed a rapid onset of effect with sustained efficacy through evening hours. This contrasts with many existing extended-release formulations that may require a midday booster dose. The technology is designed to provide control of drug release at precise, pre-defined times using a proprietary Erosion Barrier Layer (EBL). The safety profile of CTx-1301 has remained consistent over the course of nine clinical trials as of March 2025.

Flexibility of dosing without regard to food intake

A key convenience factor is the lack of restriction on meal timing. A food effect study conducted in healthy adults using a single 50 mg dose of CTx-1301 reported that the primary endpoint was met, demonstrating that CTx-1301 can be taken with or without food. This flexibility simplifies the patient's daily routine significantly.

Improved patient adherence by eliminating multiple daily doses

The core benefit here is simplifying the regimen. For CTx-1301, this means moving from potentially multiple daily doses to just one. For the anxiety candidate, CTx-2103 (buspirone), the value is even more pronounced against the standard of care. Buspirone is typically taken two to three times a day (BID or TID) due to its short half-life. Cingulate Inc. is developing CTx-2103 to be a once-daily formulation, which should inherently boost adherence in the $5.5 billion US anxiety market.

The following table summarizes the key financial context and product-specific metrics underpinning these value propositions as of late 2025.

Novel, non-benzodiazepine treatment option for anxiety (CTx-2103)

CTx-2103 uses buspirone, which is an azapirone derivative and a 5-hydroxytryptamine receptor 1A (5-HT1A) partial agonist, offering an alternative to benzodiazepines and their associated withdrawal and dependency issues. The development of CTx-2103 is being accelerated by a $3 million non-dilutive grant, paid in three $1 million installments. The foundation providing this funding will receive future royalties capped at a cumulative $3.5 million. An early-phase study showed the 30 mg CTx-2103 tablet delivered buspirone spread across three peaks, supporting the once-daily goal. The company expects this grant will cover development costs through mid-2026, aligning with the targeted Investigational New Drug Application (IND) timing.

The company's Q3 2025 operating costs reflect this development push, with Research and Development Expenses at $2.8 million and General and Administrative Expenses at $3.1 million for that quarter. The market capitalization for Cingulate Inc. stood at $21 million as of late October 2025.

Cingulate Inc. (CING) - Canvas Business Model: Customer Relationships

You're preparing to launch a novel, once-daily ADHD treatment, CTx-1301, pending FDA approval, so your customer relationship strategy is focused heavily on pre-launch readiness and commercial infrastructure build-out as of late 2025. This means leveraging external expertise and managing capital carefully while communicating key regulatory progress to the market.

Dedicated medical affairs and sales force engagement with key prescribers

Cingulate Inc. has significantly advanced its commercial leadership structure to prepare for the potential launch of CTx-1301. Industry veteran Bryan Downey was appointed Chief Commercial Officer on November 3, 2025, specifically to lead launch preparation and oversee the execution of the Indegene partnership, which includes field deployment. This signals a shift in focus toward direct prescriber engagement. While current field deployment numbers aren't public for late 2025, historical planning from 2022 suggested a need for a combined sales force of 250 to 300 professionals to effectively cover high-volume neurology, psychiatry, and primary care prescribers upon launch. The General and Administrative (G&A) Expenses for the third quarter ending September 30, 2025, were $3.1 million, an increase of 69.7% compared to the same period in 2024, driven in part by commercial costs incurred in preparation for a potential mid-2026 launch.

Omnichannel digital marketing and medical communications (via Indegene)

Cingulate Inc. relies on a comprehensive joint commercialization agreement with Indegene, Inc. for its go-to-market strategy. This partnership covers cross-functional services, including medical communications and omnichannel marketing, designed to optimize prescriber reach. The agreement spans services like sales, medical affairs, and marketing, and is designed to continue for three years post-launch of CTx-1301. The G&A expenses for Q3 2025 included commercial costs related to this contract.

High-touch support for payers regarding formulary inclusion and reimbursement

The Indegene agreement explicitly includes support for Pricing, Reimbursement, and Market Access (PRMA). You are actively engaging payers now, as early payer research indicates strong formulary receptivity for the differentiated profile of once-daily CTx-1301. This high-touch support is crucial given the need to secure favorable placement ahead of the potential May 31, 2026, Prescription Drug User Fee Act (PDUFA) target action date.

Patient support programs to drive adherence post-launch

The commercialization plan with Indegene incorporates patient support elements. Since CTx-1301 is engineered to address adherence challenges through its true once-daily dosing, the support programs are designed to reinforce this benefit post-launch. Specific enrollment numbers for these programs are not yet public, as the product awaits FDA approval.

Investor relations to communicate regulatory and financial milestones

Investor Relations has been highly active communicating the transition from a development-stage to a commercial-stage company. Key milestones communicated in late 2025 include:

• FDA acceptance of the CTx-1301 New Drug Application (NDA) in October 2025.
• Setting the PDUFA target action date for May 31, 2026.
• Receiving a small-business PDUFA fee waiver, saving approximately $4.3 million.
• Completing a $6 million financing transaction on November 3, 2025, structured as a non-convertible, unsecured promissory note accruing interest at 9% per annum.
• As of September 30, 2025, cash on hand was $6.1 million, with working capital at $1.6 million.
• The company estimates needing to raise approximately $7.0 million of additional capital to fund commercialization efforts through the PDUFA date.

You can reach the VP of Corporate Communications, Thomas Dalton, at (913) 942-2301, or the investor relations firm, Darrow Associates, at (214) 597-8200.

Here's a quick look at the financial context supporting these commercial relationship investments as of the end of Q3 2025:

The appointment of Bryan Downey as CCO, coupled with the Indegene contract, shows you are prioritizing commercial execution readiness. Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Channels

You're looking at how Cingulate Inc. plans to get its product, CTx-1301, from the manufacturer to the patient, especially since the New Drug Application (NDA) was accepted in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026. This is all pre-launch, so the channels are set up via agreements and personnel hiring.

The core of the physical supply chain relies on established pharmaceutical infrastructure. Cingulate Inc. executed a commercial supply agreement with Bend Bio Sciences in September 2025, naming them the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, subject to FDA approval. This agreement dictates that Cingulate Inc. commits to purchasing 100% of its overall U.S. commercial supply from Bend Bio Sciences.

For getting the product into the market, the company has leaned on external expertise. Cingulate Inc. partnered with Indegene, Inc. to support the commercialization of CTx-1301 in the U.S., leveraging Indegene's infrastructure. General and Administrative Expenses for the third quarter ending September 30, 2025, included commercial costs related to this contract, totaling $3.1 million for the three months ended September 30, 2025.

The structure for direct physician engagement is being built out now. In November 2025, Cingulate Inc. appointed Bryan Downey as Chief Commercial Officer to lead these commercial activities for the potential launch. While the actual 2025 sales force size isn't reported, planning data from 2022 suggested a need for a combined force of 250-300 sales professionals to cover high-volume neurology, psychiatry, and primary care prescribers at launch.

The planned channel strategy involves leveraging the existing network for broad access, which is standard for a new CNS product launch. The company anticipates needing approximately $7.0 million to $9 million of additional capital to advance these commercialization efforts through the PDUFA date and into the potential launch phase.

Here is a summary of the key channel-related operational and financial data as of late 2025:

The intended reach for the product, once approved, is structured as follows:

• Pharmaceutical wholesalers and national distributors: Access secured via the commercial supply agreement with Bend Bio Sciences.
• Retail pharmacy chains and independent pharmacies: Target access point for CTx-1301 distribution.
• Specialty pharmacies for complex reimbursement cases: Strategy to be executed post-launch, supported by the new commercial team.
• Direct-to-physician marketing and sales force detailing: Led by the newly appointed Chief Commercial Officer, Bryan Downey.

Cingulate Inc. (CING) - Canvas Business Model: Customer Segments

You're looking at Cingulate Inc.'s customer base as they push toward a potential 2026 launch for CTx-1301. Honestly, understanding these segments is key because their success hinges on adoption by patients, prescribers, and the payers who control access.

The primary patient groups Cingulate Inc. targets are those living with Attention Deficit Hyperactivity Disorder (ADHD) in the U.S. As of their first quarter 2025 report on March 31, 2025, the total U.S. patient pool was reported to be over 20 million individuals diagnosed with ADHD. This massive population is split across two core segments that Cingulate Inc. is addressing with its once-daily stimulant candidate, CTx-1301.

For the pediatric and adolescent segment, Cingulate Inc. is targeting the over 8 million patients under the age of 17 as of March 31, 2025. This group is highly familiar with stimulant treatment, but the promise of a 'true, once-daily' formulation is what aims to capture their attention and improve compliance. In the broader context, U.S. children aged 5 to 17 have a lifetime diagnosis prevalence where boys show a rate of 14.5% versus girls at 8.0%.

The adult segment is equally, if not more, critical. Cingulate Inc. reported 12 million adults diagnosed with ADHD as of March 31, 2025. Current market trends suggest this adult prevalence is larger and growing faster than the child and adolescent segments combined. This segment is specifically looking for improved once-daily efficacy to manage symptoms throughout their entire active day, which is what CTx-1301 is designed to deliver. By 2024, the adults segment already held the highest market share within the U.S. ADHD market, and it is forecast to expand at an 8.23% CAGR through 2030.

The market opportunity for Cingulate Inc. is substantial, given that stimulant medications, which CTx-1301 is a part of, anchor the majority of prescriptions. Here's a quick look at the market context Cingulate Inc. is preparing to enter:

The next set of customers are the healthcare professionals who write the scripts. These are the psychiatrists, pediatricians, and primary care physicians who prescribe stimulants. Cingulate Inc. is focused on convincing these prescribers that CTx-1301 offers a superior duration profile over existing options. It's important to note that in 2023, nurse practitioners prescribed more than 75% of all stimulant prescriptions, making them a key specialty to target alongside MDs. Cingulate Inc. definitely signaled its intent to reach this group by appointing Bryan Downey as Chief Commercial Officer in November 2025 to lead launch preparation.

Finally, you have the gatekeepers: managed care organizations and Pharmacy Benefit Managers (PBMs). These entities determine formulary placement and patient access, which directly impacts prescription volume. Cingulate Inc. is preparing for this by executing commercial strategies; for instance, they announced a commercial supply agreement with Bend Bio Sciences in the third quarter of 2025. Their ability to secure favorable coverage will be tied to the clinical differentiation of CTx-1301, especially against established, often generic, stimulant therapies. The company expects its current cash position to satisfy capital needs into the second quarter of 2026, but advancing commercialization efforts through the May 31, 2026, Prescription Drug User Fee Act (PDUFA) date will require raising approximately $7.0 million of additional capital.

• Cingulate Inc. completed its Pre-NDA meeting with the FDA on April 2, 2025.
• The New Drug Application (NDA) for CTx-1301 was accepted by the FDA in October 2025.
• The PDUFA target action date is set for May 31, 2026.
• CTx-1301 utilizes dexmethylphenidate HCl, an already FDA-approved compound.

Cingulate Inc. (CING) - Canvas Business Model: Cost Structure

You're looking at the cash burn Cingulate Inc. faces while pushing CTx-1301 toward its May 31, 2026, PDUFA date. The cost structure is heavily weighted toward getting the drug approved and ready for market.

Research and development (R&D) expenses for the three months ended September 30, 2025, totaled $2.8 million. This was a significant jump, up 99.5% compared to the same period in the prior year.

General and administrative (G&A) costs for the third quarter of 2025 were $3.1 million. This represented a 69.7% increase year-over-year, primarily driven by personnel costs, including contingent bonus plan accruals upon the CTx-1301 New Drug Application (NDA) submission in Q3 2025, plus other general overhead.

Here's a quick look at the main operating expenses for the third quarter of 2025:

Manufacturing and supply chain costs for CTx-1301 production saw an increase during 2025. This rise was specifically tied to the significant manufacturing costs related to preparing the process validation batches for CTx-1301. Cingulate Inc. also entered a commercial supply agreement with Bend Bio Sciences, which signals future commitment to production scale-up.

Pre-commercialization and sales force build-out expenses are ramping up as the company prepares for a potential mid-2026 launch. The hiring of Bryan Downey as Chief Commercial Officer on November 3, 2025, is a clear indicator of this shift in spending focus. To manage this transition and cover costs through the May 31, 2026, PDUFA date, Cingulate Inc. stated it will need to raise approximately $7.0 million of additional capital.

Financing costs include interest expense from recent debt. On November 3, 2025, Cingulate Inc. completed a financing structured as a $6,570,000 non-convertible, unsecured promissory note. This note accrues interest at 9% per annum and matures 18 months from issuance. This debt structure adds a fixed financing cost to the structure.

The company's cost structure is currently dominated by R&D and G&A, which contributed to a net loss of $7.3 million for the third quarter of 2025. Finance: draft 13-week cash view by Friday.

Cingulate Inc. (CING) - Canvas Business Model: Revenue Streams

You're looking at Cingulate Inc.'s near-term financial scaffolding, which is heavily reliant on near-term financing and regulatory success as of late 2025. The primary long-term revenue driver hinges on the success of CTx-1301, but the immediate cash flow is being supplemented by non-dilutive funding and debt instruments.

The most significant potential revenue stream is the future commercialization of CTx-1301 (dexmethylphenidate HCl). Following the NDA acceptance in October 2025, the Prescription Drug User Fee Act (PDUFA) target action date is set for May 31, 2026. Cingulate Inc. has projected that CTx-1301 could generate peak sales of US$1.6 billion by 2035. This is set against the backdrop of the U.S. ADHD market, estimated to be valued at more than US$20 billion.

The company has also secured non-dilutive funding, which is crucial as it doesn't dilute existing shareholder equity. This includes a $3 million grant from a private foundation to accelerate CTx-2103 development.

• The $3 million grant is paid in three installments of $1 million each.
• The foundation receives a future royalty on CTx-2103 commercialization of $500,000 per quarter, capped at a maximum cumulative royalty of $3.5 million.
• The grant is projected to cover CTx-2103 development costs through mid-2026.

To bridge the gap to potential launch revenue, Cingulate Inc. executed a financing transaction in November 2025. This debt financing provided immediate liquidity for working capital and general corporate purposes.

Furthermore, Cingulate Inc. realized a significant, one-time financial benefit through a regulatory fee waiver. This saved immediate cash outlay as they prepared the CTx-1301 New Drug Application (NDA).

The company is also looking at future, less certain revenue streams tied to its core technology, the Precision Timed Release (PTR) platform. Exploring out-licensing opportunities for the platform is part of the strategy to diversify beyond single-asset risk.

• The first projected loss of exclusivity for the PTR platform intellectual property is 2035.
• Milestone payments from out-licensing are a potential, though not yet quantified, revenue source.

Finally, the immediate financial impact of the PDUFA fee waiver is a direct boost to the balance sheet, preserving capital that would otherwise have been spent on regulatory filing fees.

The fiscal year 2025 PDUFA fee waiver from the FDA, granted under the small business provision, saved Cingulate Inc. approximately $4.3 million. This is a direct, realized saving that strengthens the cash position ahead of the PDUFA date. Finance: review the projected capital need of $7.0 million against the current cash position of $6.1 million as of September 30, 2025.