DALLAS, TX -- August 21st, 2025 -- Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 2Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301. The Company remains focused on advancing its Precision Timed Release™ (PTR™) platform, designed to address gaps in current ADHD treatments by enabling true once-daily dosing. With a differentiated product profile and a large U.S. market opportunity, management is preparing for commercialization while also evaluating opportunities to broaden its global footprint through strategic partnerships.
Company Updates:
NDA Submission and FDA Approval Pathway: In August 2025, Cingulate achieved a major milestone with the submission of its New Drug Application (NDA) to the FDA for lead ADHD asset, CTx-1301. The NDA, filed on July 31, 2025, incorporates data from nine clinical studies, including pivotal pediatric and adult trials, and represents the Company’s first regulatory application of its Precision Timed Release™ (PTR™) platform. The FDA is expected to decide on acceptance by 4Q25, which could set up a potential PDUFA date in mid-2026. With a differentiated clinical profile and significant unmet need in ADHD, Cingulate is advancing commercialization readiness, supported by a recently expanded $25 million purchase agreement with Lincoln Park Capital to provide additional financial flexibility.
Pipeline Update: Cingulate’s pipeline is anchored by its lead asset, CTx- 1301. The Company is also advancing CTx-1302 (dextroamphetamine), which uses the same PTR™ technology to provide full-day coverage for patients who respond better to amphetamine-based therapies, with pivotal-stage studies planned. In addition, early-stage candidate CTx-2103 is in formulation for anxiety disorders, reflecting the scalability of the PTR™ platform and the Company’s strategy to expand into large, underserved psychiatric markets.
Balance Sheet, Cash Flows, and Financing Strategy: As of 2Q25, Cingulate reported cash and cash equivalents of $8.9M and $3.5M in working capital. Management expects its current resources to fund operations into late 2025 but noted that additional financing will be required to advance commercialization efforts for CTx-1301 into early 2026. Research and development expenses totaled $2.7M, up 44.0% y/y due to NDA preparation and regulatory costs, while general and administrative expenses rose 47.0% to $1.9M, primarily reflecting legal and advisory fees. Net loss for the quarter was $4.8M compared to $3.2M in the prior year period.
Management Update: On August 15, 2025, the Company announced that Jennifer Callahan, previously Chief Financial Officer, was appointed Interim CEO while continuing to serve as CFO. Industry veteran and board member Jay Roberts was appointed Executive Chairman. We believe this transition provides continuity and enhances leadership focus during a critical pre-commercial phase.
Valuation: We use a Discounted Cash Flow Model when determining a valuing range. Our valuation model returns a range of $15.03 to $30.46 with a midpoint of $21.28. More details can be found on the Valuation page.
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