Cingulate Inc. (CING)·Q2 2025 Earnings Summary

Executive Summary

• Cingulate submitted its NDA for lead ADHD asset CTx-1301 on July 31, expects FDA acceptance decision in Q4 2025 and a potential PDUFA date in mid-2026; Q2 also brought a $4.3M PDUFA fee waiver and a new $25M Lincoln Park equity purchase agreement to bolster liquidity .
• Q2 2025 EPS of -$1.09 missed Wall Street consensus of -$0.82; revenue remains pre-commercial with no product sales reported . Consensus data: EPS -$0.8225*, Revenue $0.0* (Primary EPS - # of Estimates = 4*)
• Operating expenses rose YoY (R&D +43.6%, G&A +47.1%) as NDA-prep and regulatory costs accelerated; net loss widened to $4.79M vs $3.21M a year ago .
• Management changes created headline risk: CEO placed on administrative leave; CFO Jennifer Callahan appointed Interim CEO; Jay Roberts named Executive Chairman; cash runway guided “into late 2025” with ~$1.5M additional capital needed to carry commercialization efforts into early 2026 .
• Near‑term catalysts: FDA acceptance decision (Q4 2025), progress on financing (ATM/Lincoln Park, Streeterville exchanges), and commercialization build-out (Indegene MSA) .

What Went Well and What Went Wrong

What Went Well

• NDA for CTx-1301 submitted; company highlighted “fast onset” and “entire active-day efficacy” profile with supportive Phase 3 safety data and fed/fast studies demonstrating dosing flexibility (“with or without food”) .
• $4.3M FDA PDUFA fee waiver substantially reduced near‑term cash needs; management emphasized strengthened financial position ahead of submission .
• Liquidity actions: New $25M Lincoln Park purchase agreement and ongoing ATM usage; subsequent note principal exchanges into equity after quarter-end further improved flexibility .

What Went Wrong

• EPS missed consensus by $0.27 driven by higher operating costs tied to NDA activities; net loss widened YoY (Q2: -$4.79M vs -$3.21M) and sequentially (Q1: -$3.80M) .
• Going concern disclosure highlights need for additional capital; management estimates ~$1.5M to bridge commercialization efforts into early 2026 and cites substantial doubt without further financing .
• Leadership disruption: CEO placed on administrative leave for personal legal matters, with interim leadership transitions—an investor overhang until resolved .

Financial Results

Notes:

• Revenue: Company remains pre‑revenue; “Since inception, we have not generated any revenue” .
• Single operating segment: Company operates as one segment; CODM evaluates performance via net loss .

Vs. Estimates

Values with asterisks retrieved from S&P Global.

Guidance Changes

Earnings Call Themes & Trends

No earnings call transcript was available for Q2 2025; themes below reflect prepared remarks and the 10‑Q.

Management Commentary

• “Submission of the NDA to the FDA for lead asset CTx-1301 marked a pivotal moment… the Lincoln Park Capital [agreement] allows management to be opportunistic in its capital needs as we prioritize pre‑commercial activities… in anticipation of the launch… in mid‑2026, pending FDA approval.” — Jay Roberts, Executive Chairman .
• “The submission of the NDA for CTx-1301 is the culmination of years of clinical and manufacturing development… we believe CTx-1301 addresses key limitations of existing therapies and has the potential to improve outcomes for patients across age groups.” — Matthew Brams, MD, CMO .
• Liquidity/going concern: Cash $8.9M at Q2 end; substantial doubt about ability to continue as a going concern without additional financing; ~$1.5M required to advance commercialization efforts .

Q&A Highlights

• No Q2 2025 conference call transcript was available; no Q&A highlights to report [ListDocuments returned none; MarketBeat indicated call timing but no transcript link] .

Estimates Context

• EPS missed consensus: Actual -$1.09 vs -$0.8225*, driven by higher R&D and G&A tied to NDA preparation and regulatory costs; analysts’ models may need to reflect elevated OpEx through FDA acceptance and pre‑commercial build .
• Revenue remains pre‑commercial; consensus was $0.0* and actual N/A; estimate models should continue to carry zero revenue until commercialization .
  Values with asterisks retrieved from S&P Global.

Key Takeaways for Investors

• Regulatory catalyst path is clear: FDA acceptance decision in Q4 2025 and possible PDUFA in mid‑2026; timeline execution has been consistent since Q4 2024/Q1 2025 .
• Liquidity is improved but not sufficient: cash $8.9M at quarter-end; $25M LP facility signed; ~$1.5M more capital needed to carry commercialization efforts into early 2026; going concern risk disclosed .
• Cost trajectory likely elevated near term: R&D and G&A grew 44% and 47% YoY on NDA and regulatory activities; expect continued OpEx investment into acceptance and commercialization prep .
• Leadership overhang: CEO placed on administrative leave; interim leadership structure in place; monitor stability and any impact on execution or financing .
• Commercial readiness building: Indegene partnership provides commercialization infrastructure; supports faster scale once approved .
• Financing covenants matter: Streeterville note restricts certain issuances and can escalate on default; watch future equity/dilution dynamics and covenant constraints .
• No non‑GAAP adjustments or product revenue yet; thesis hinges on regulatory momentum and capital discipline until commercialization .

Appendix: Additional Data

Operating Expense Detail (Q2 2025 vs Q2 2024)

Capital Actions & Subsequent Events

• ATM: 364,963 shares sold in Q2 for net proceeds $1.58M; post‑Q2 64,682 shares sold for $0.34M .
• Lincoln Park: $25M 2025 agreement; issued 120,424 commitment shares; sold 69,389 shares in Aug for $0.35M net .
• Streeterville exchanges: $1.225M of note principal exchanged for 268,738 common shares after Q2 .