Cingulate Inc.

Current report

Reference is made to Part I Item 1A. Risk Factors in our Annual Report on Form 10–K for the year ended December 31, 2025, which sets forth information relating to important risks and uncertainties that could materially adversely affect our business, financial condition or operating results. Except as set forth below, there have been no material changes to the risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current report

We depend heavily on the success of CTx-1301. We received a Complete Response Letter from the FDA citing certain manufacturing deficiencies and other non-clinical issues, which may delay or prevent approval of CTx-1301.

Current report

Our most advanced product candidate currently is CTx-1301, for which we submitted a NDA with the FDA in July 2025. We do not currently generate revenues from any FDA approved drug products and our other product candidates are in the early stages of development. There is no guarantee that our clinical trials will be successful or that we will continue with clinical studies to support an approval from the FDA of any of our product candidates for any indication. We note that most drug candidates never reach the clinical development stage and even those that do have only a small chance of successfully completing clinical development and gaining regulatory approval. Therefore, our business currently depends heavily on the successful development, regulatory approval and commercialization of CTx-1301, which may never occur. In June 2026, we received a Complete Response Letter (“CRL”) for our New Drug Application (“NDA”) for CTx-1301. The CRL identified specific Chemistry, Manufacturing and Controls (CMC) information requests. While the CRL did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301, we are in the process of generating additional data as requested.

Current report

Moreover, we will rely in large part on Bend Bioscience, our contract development and manufacturing organization (“CDMO”) to remediate the identified deficiencies.

Current report

If we or our CDMO cannot sufficiently address the issues set forth in the CRL, we may not be able to resubmit the NDA, or resubmission may not result in approval. If we do resubmit the NDA, the FDA may conduct a re-inspection of our CDMO, and there can be no assurance that the facility will be found compliant or that additional deficiencies will not be identified. As a result, approval of CTx-1301 may be significantly delayed, limited, or may not be obtained at all, any of which could materially and adversely affect our business, financial condition, results of operations and prospects.

Current report

Premarket review of our product candidates by the FDA or other regulatory authorities is a lengthy and uncertain process and approval may be delayed, limited or denied, any of which would adversely affect our ability to generate operating revenues.

Current report

We are not permitted to market our drug product candidates in the United States until we receive the respective approval of a NDA from the FDA. The time required to obtain approval, if any, by the FDA is unpredictable, but typically takes multiple years following the commencement of clinical trials, and depends upon numerous factors, including the substantial discretion of the regulatory authorities and the type, complexity and novelty of the product candidates involved. Our most advanced product candidate currently is CTx-1301, for which we submitted a NDA with the FDA in July 2025. We received a CRL for our NDA for CTx-1301 in June 2026.

Current report

We plan to resubmit our NDA, however, the FDA has substantial discretion in the drug approval process, including the ability to delay, limit or deny approval of the resubmission. The FDA may also conduct a re-inspection of our CDMO, and there can be no assurance that the facility will be found compliant or that additional deficiencies will not be identified. For additional information, see “—We depend heavily on the success of CTx-1301. We received a Complete Response Letter from the FDA citing certain manufacturing deficiencies, which may delay or prevent approval of CTx-1301”.

Current report

Our efforts (and those of our contract manufacturer) to develop, make and win approval for CTx-1301 continue to be subject to inspection and approval by the FDA and other factors outside of our control, and there remains a risk that the required FDA approvals of CTx-1301 and/or the third party facilities used to manufacture CTx-1301 could be further delayed or not obtained. There can be no assurance that a resubmission of the NDA of CTx-1301 will be approved or that such resubmission will occur at all, which would significantly harm our business, results of operations and prospects.

Current report

We must ensure our CDMO complies with cGMP, and regulatory inspections or findings could interrupt supply and delay development.

Current report

We must ensure that our CDMO complies with cGMP regulations. Manufacturing deviations, documentation errors, or quality system gaps at CDMOs can lead to Form 483 observations, warning letters, or import alerts, jeopardizing clinical supply continuity. Pre-approval inspections assess readiness for commercial production and can reveal issues that require significant remediation time and investment. In February 2026, the FDA conducted a pre-approval inspection of our CDMO’s facility used to manufacture CTx-1301. This facility was issued a Form 483 by the FDA at the conclusion of the inspection with three observations. Two observations were related to the facility and one observation was specific to CTx-1301. Our CDMO is working on responses to these observation, with our input where relevant. The FDA may also conduct a re-inspection of our CDMO if and when we resubmit our NDA for CTx-1301, and there can be no assurance that the facility will be found compliant or that additional deficiencies will not be identified. For additional information, see “—We depend heavily on the success of CTx-1301. We received a Complete Response Letter from the FDA citing certain manufacturing deficiencies and other non-clinical issues, which may delay or prevent approval of CTx-1301.” Our efforts continue to be subject to inspection and approval by the FDA and other factors outside of our control, and there remains a risk that the required FDA approvals of CTx-1301 and/or our CDMO’s facility used to manufacture CTx-1301 could be further delayed or not obtained.

Current report

Moreover, changes to manufacturing processes or facilities can trigger comparability assessments or bridging studies, adding regulatory complexity. If our CDMO loses licensure or fails to meet cGMP standards, transitioning to an alternate CDMO may be lengthy and costly, potentially delaying development and commercialization. See “—We rely on third-parties, many of whom are our single source for services, products and/or supplies, over whom we have limited control. Should the cost, delivery and/or quality of services, products or supplies provided by these third-parties vary to our disadvantage, our business operations could suffer significant harm.”

Current report

We rely on third-parties, many of whom are our single source for services, products and/or supplies, over whom we have limited control. Should the cost, delivery and/or quality of services, products or supplies provided by these third-parties vary to our disadvantage, our business operations could suffer significant harm.

Current report

We are a research and development company and have limited experience in commercial manufacturing. To conduct late-stage clinical trials, as well as manufacture and commercialize our drug candidates, we engage a CDMO and suppliers in the U.S. to manufacture our drug candidates on a large scale at a competitive cost and in accordance with cGMP and regulatory requirements, as applicable. We also rely on third parties for filling, labeling and storage for studies inside and outside the U.S.

Current report

Moreover, while we will try to obtain multiple sources whenever possible, similar to other clinical stage pharmaceutical companies, all stages of our manufacturing process are currently completed by a single CDMO, which could expose us to a number of risks related to our supply chain if and when we become a commercial stage company, including delivery failure and drug shortages. To date, we have no qualified alternative sources. Any manufacturing failures or compliance issues experienced by our CDMO could cause delays in our clinical studies or commercialization of our drug candidates.

Current report

In June 2026, we received a CRL for our NDA for CTx-1301. The CRL identified specific Chemistry, Manufacturing and Controls (CMC) information requests. We will need to rely in large part on our CDMO to remediate the identified deficiencies, and our ability to resolve these issues is subject to factors outside our control.

Current report

Remediation may require facility upgrades, quality system enhancements, equipment requalification, and additional validation studies or testing, any of which could be costly and time-consuming. If our CDMO is unable to adequately or timely remediate the identified deficiencies, we may need to transfer manufacturing operations to an alternative facility, which would involve significant time, expense and regulatory risk. . For example, in October 2022, we announced a new CDMO. The CTx-1301 fixed-dose study was delayed while the manufacturing process with the new CDMO was established to manufacture the final dosage strengths needed for the fixed-dose study. We also may be unable to identify or establish manufacturing at an adequate alternative facility.

Current report

In order for us to establish our own commercial manufacturing facility, we would require substantial additional funds and we would need to acquire a manufacturing facility, make facility modifications, hire and retain significant additional personnel and comply with extensive cGMP regulations applicable to such a facility. The commercial manufacturing facility would also need to be licensed for the production of our drug candidates by the FDA and meet other regulatory standards. We therefore work with our CDMO under established manufacturing arrangements that comply with the FDA’s requirements and other regulatory standards, although there is no assurance that the manufacturing will be successful.

Current report

Use of third-party manufacturing facilities limits our control over and ability to monitor the manufacturing process. As a result, we may not be able to detect a variety of problems that may arise and may face additional costs in the process of interfacing with and monitoring the progress of our CDMO. If our CDMO fails to meet our manufacturing needs in an acceptable manner or fail to comply with regulatory requirements, we would face delays and additional costs while we develop internal manufacturing capabilities or find alternate sources. It may not be possible to have multiple manufacturers ready to supply us with needed material at all or without incurring significant costs. Our dependence upon third-party manufacturing facilities for the manufacture of our products may adversely affect our profit margins and our ability to develop, manufacture, sell and deliver products on a timely and competitive basis. Any manufacturing failures, supply chain delays or compliance issues could cause delays in our clinical studies for our drug candidates, FDA approval of our product candidates, and, if approved, commercialization of our product candidates.

Current report

Prior to approval of CTx-1301 or any product candidate, the FDA must review and approve validation studies for both drug substance and drug product. In February 2026, the FDA conducted a pre-approval inspection of our CDMO’s facility used to manufacture CTx-1301. This facility was issued a Form 483 by the FDA at the conclusion of the inspection with three observations. Two observations were related to the facility, and one observation was specific to CTx-1301. The FDA may also conduct a re-inspection of our CDMO if and when we resubmit our NDA for CTx-1301, and there can be no assurance that the facility will be found compliant or that additional deficiencies will not be identified. For additional information, see “—We depend heavily on the success of CTx-1301. We received a Complete Response Letter from the FDA citing certain manufacturing deficiencies and other non-clinical issues, which may delay or prevent approval of CTx-1301”. Our efforts continue to be subject to inspection and approval by the FDA and other factors outside of our control, and there remains a risk that the required FDA approvals of CTx-1301 and/or our CDMO’s facility used to manufacture CTx-1301 could be further delayed or not obtained.

Current report

These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product candidates, cause us to incur higher costs and prevent us from commercializing them successfully. Furthermore, if our suppliers fail to deliver the required commercial quantities of components and APIs on a timely basis and at commercially reasonable prices, including if our suppliers did not receive adequate DEA quotas for the supply of certain scheduled components, and we are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, commercialization of our product candidates, and clinical trials of future potential product candidates, may be delayed or we could lose potential revenue and our business, financial condition, results of operation and reputation could be adversely affected.

Current report

From May 11, 2026 through July 7, 2026, we issued the securities described below in transactions that were not registered under the Securities Act of 1933, as amended (Securities Act).

Current report

On May 11, 2026, we issued 38,343 shares of common stock at a value of $5.22 per share to a lender in exchange for a portion of the debt owed to such lender. Such issuance was exempt from registration under 3(a)(9) of the Securities Act.

Current report

On May 27, 2026, we issued 55,928 shares of common stock at a value of $4.47 per share to a lender in exchange for a portion of the debt owed to such lender. Such issuance was exempt from registration under 3(a)(9) of the Securities Act.

Current report

On May 28, 2026, we issued 53,030 shares of common stock at a value of $3.96 per share to a lender in exchange for a portion of the debt owed to such lender. Such issuance was exempt from registration under 3(a)(9) of the Securities Act.

Current report

On July 7, 2026, we issued 67,924 shares of common stock at a value of $5.30 per share to a lender in exchange for a portion of the debt owed to such lender. Such issuance was exempt from registration under 3(a)(9) of the Securities Act.

Current report

On August 10, 2026, we issued 71,827 shares of common stock at a value of $5.01 per share to a lender in exchange for a portion of the debt owed to such lender. Such issuance was exempt from registration under 3(a)(9) of the Securities Act.

Previous report

Our business is subject to substantial risks and uncertainties. Investing in our securities involves a high degree of risk. You should carefully consider the risk factors in Part I, Item 1A of our Form 10-K for the year ended December 31, 2025, together with the information contained elsewhere in this report, including Part I, Item 1 “Financial Statements” and Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other SEC filings in evaluating our business. These risks and uncertainties could materially and adversely affect our business, financial condition, results of operations, prospects for growth, and the value of an investment in our securities.

Previous report

None.