"Cingulate remains focused on disciplined execution in 2026 and we believe we are well positioned to bring our lead ADHD asset, CTx-1301, to market," said Cingulate CEO Shane J. Schaffer. "We continue to engage constructively with the FDA on our new drug application while advancing commercial readiness and manufacturing capabilities, and believe our current resources provide an extended cash runway into 2027."
Strengthened Balance Sheet
Cingulate enters the second quarter of 2026 with a meaningfully stronger financial position, having grown its cash and cash equivalents to $25.9 million as of March 31, 2026, a $14.9 million increase from December 31, 2025, driven by the successful close of a $12.0 million at-the-market private placement in February 2026 alongside opportunistic usage of the Company's at-the-market and stock purchase agreements. Working capital increased to $17.0 million from $1.7 million at year-end, reflecting the Company's significantly improved liquidity. Management believes this capital base is sufficient to fund operations into 2027, supporting key value-creating milestones including the pursuit of regulatory approval and launch readiness for CTx-1301.
Regulatory Update
Cingulate is actively collaborating with the FDA to provide responses to information requests related to the manufacturing and CMC elements of its CTx-1301 NDA. The Company remains committed to working efficiently with the Agency and will provide updates as the review process progresses.
Commercial Readiness Update
Cingulate continues to advance its commercialization preparations, with dedicated teams established across all key functional areas. The Company's launch strategy leverages a commercialization strategy augmented by AI-driven tools designed to optimize targeting, decision-making, and performance measurement, positioning Cingulate for a rapid commercial launch contingent upon FDA approval. Key areas of focus include:
Market Access and Payer Engagement: Advancing payer strategy and reimbursement frameworks
Distribution and Supply Chain: Preparing distribution infrastructure and supply chain capabilities
Omnichannel Infrastructure: Deploying a comprehensive AI-augmented marketing technology to support targeting and performance optimization across channels
Commercial Manufacturing: Scaling manufacturing operations and advancing process validation batch preparation for CTx-1301, which will serve as launch inventory if approved
Field Force Optimization: Building out Cingulate's sales team through an agreement with IQVIA Inc. for deployment upon potential FDA approval
First Quarter Results
Cash and Working Capital: As of March 31, 2026, Cingulate had approximately $25.9 million in cash and cash equivalents, a $14.9 million increase from December 31, 2025. The increase in cash was primarily driven by capital raised in the first quarter, including the close of a $12.0 million private placement. As of March 31, 2026, Cingulate had approximately $17.0 million in working capital, an increase of $15.3 million as compared to $1.7 million as of December 31, 2025.
R&D Expenses: R&D expenses were $2.2 million for the three months ended March 31, 2026, a decrease of 1.8% from the three months ended March 31, 2025. The decrease is the result of lower clinical operations costs as clinical study activities concluded in early 2025, offset by an increase in regulatory and manufacturing activities in the first quarter of 2026 relating to the NDA review of CTx-1301.
G&A Expenses: General and administrative expenses were $5.7 million for the three months ended March 31, 2026 compared to $1.5 million for the same period in 2025. This increase is primarily the result of costs incurred relating to the build-out of the commercial infrastructure for the launch of CTx-1301, pending FDA approval, including increased headcount.
Net Loss: Net loss was $9.3 million for the three months ended March 31, 2026, compared to $3.9 million for the three months ended March 31, 2025. The increase in the net loss primarily relates to increased G&A expenses as described above as well as the change in fair value of derivative and interest on our notes payable.
Cingulate Inc.
Consolidated Balance Sheet Data
March 31,
December 31,
2026
2025
Cash and cash equivalents
$
25,893,210
$
10,953,383
Total assets
$
30,861,701
$
15,073,263
Total liabilities
