Cingulate Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash and cash equivalents increased to approximately $23.2 million as of September 30, 2026, from $11.0 million as of December 31, 2025.
• Working capital rose to approximately $18.8 million as of September 30, 2026, an increase of $16.1 million compared to $1.7 million at December 31, 2025.
• Research and development (R&D) expenses were $2.9 million for the three months ended September 30, 2026, a 2.2% increase from $2.8 million in the same period in 2025.
• R&D expenses were $6.6 million for the nine months ended September 30, 2026, a 15.3% decrease from $7.8 million in the same period in 2025.
• Selling, general and administrative (SG&A) expenses were $4.6 million for the three months ended September 30, 2026, a 45.5% increase from $3.1 million in the same period in 2025.
• SG&A expenses were $14.2 million for the nine months ended September 30, 2026, a 116.6% increase from $6.6 million in the same period in 2025.
• Net loss was $7.7 million for the three months ended September 30, 2026, compared to $7.3 million for the same period in 2025.
• Net loss was $22.9 million for the nine months ended September 30, 2026, compared to $16.2 million for the same period in 2025.
• Total assets were $28.2 million as of September 30, 2026, compared to $15.1 million as of December 31, 2025.
• Total liabilities were $7.4 million as of September 30, 2026, compared to $12.6 million as of December 31, 2025.
• Total stockholders' equity was $20.8 million as of September 30, 2026, compared to $2.5 million as of December 31, 2025.
• Accumulated deficit increased to $(155.3) million as of September 30, 2026, from $(132.4) million as of December 31, 2025.

Guidance and Future Outlook:

• The Company expects to resubmit the New Drug Application (NDA) for CTx-1301 between December 2026 and January 2027.
• Upon resubmission, the FDA is expected to classify the filing as a Class 1 or Class 2 resubmission, with review goals of two and six months, respectively.
• Current cash and cash equivalents are believed to be sufficient to fund operations into mid-2027, including regulatory approval costs for CTx-1301 and commercial readiness build-out.
• The Company intends to utilize its PTR technology to expand its clinical-stage pipeline into additional therapeutic areas beyond ADHD and anxiety disorders.

Business Segments and Product Lines:

• CTx-1301 (dexmethylphenidate HCl) is the Company's lead asset, a once-daily multi-core tablet utilizing the Precision Timed Release™ (PTR™) platform for ADHD treatment.
• Manufacturing work addressing FDA Chemistry, Manufacturing and Controls (CMC) information requests for CTx-1301 has been substantially completed.
• The Company is building commercial readiness capabilities, including increased headcount and expanded market access, pricing, reimbursement, and medical affairs activities conducted through partner Indegene.
• Clinical study activities for CTx-1301 concluded in early 2025.

Market and Competitive Landscape:

• The estimated US ADHD market size is approximately 100 million annual prescriptions.
• Over 20 million patients in the U.S. have been diagnosed with ADHD, including 12 million adults and over 8 million children under 17.
• Current market trends indicate adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.
• Just 53.6% of children and teens with ADHD reported actively treating symptoms with medication in 2022.

Risks and Challenges:

• There is no assurance regarding the timing of the NDA resubmission or whether regulatory approval will occur.
• Actual results may differ materially from forward-looking statements due to various factors disclosed in SEC filings, including the "Risk Factors" section of the Form 10-K and Form 10-Q.
• The Company faces risks related to the FDA's CMC information requests and the potential for delays in the regulatory review process.

Management Commentary and Tone:

• Chairman and CEO Shane J. Schaffer stated that the FDA's Complete Response Letter did not raise concerns regarding the clinical safety or efficacy of CTx-1301.
• Management expressed confidence in finalizing data and documentation for the NDA resubmission by January 2027, potentially sooner.
• The Company thanked shareholders for their patience and continued support.

Other Key Points:

• Capital raised during the first nine months of 2026 included a $12.0 million private placement in the first quarter.
• The Company raised $22.5 million of capital through its At-the-Market Agreement with AGP and Purchase Agreement with Lincoln Park Capital.
• Approximately $20.4 million in cash was used for operations during the first nine months of 2026.
• The FDA issued a Complete Response Letter for CTx-1301 on June 1, 2026, identifying specific CMC requests but no safety or efficacy concerns.
• The PTR platform utilizes a proprietary Erosion Barrier Layer (EBL) licensed from BDD Pharma.
• The Company is headquartered in Kansas City, Kansas.