Cingulate Inc. (CING)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 net loss was $6.13M, an improvement vs $6.93M in Q4 2023, with cash and cash equivalents at $12.21M and total stockholders’ equity at $7.46M; working capital stood at $7.54M, reflecting significant balance sheet strengthening from 2024 capital raises .
• EPS came in at -$2.30 vs Wall Street consensus of -$1.53, a significant miss likely reflecting higher Q4 operating/R&D intensity as the company advanced final pre-NDA activities for CTx‑1301; consensus expected $0.00 revenue for the quarter (pre-commercial) [*S&P Global].
• Guidance and regulatory milestones advanced: in-person Pre‑NDA meeting set for April 2, 2025, with NDA submission targeted for mid‑2025; Phase 3 safety results reported with no serious treatment emergent adverse events across nine trials .
• Liquidity extended via a $5.48M promissory note for net proceeds of $5M in December 2024, extending cash runway into Q4 2025; overall, 2024 raises and warrant inducements materially fortified liquidity .
• Near-term stock reaction catalysts: Pre‑NDA meeting outcome and clarity on NDA filing timeline, plus payer study indicating likely coverage through contracting, supporting potential commercial uptake upon approval .

What Went Well and What Went Wrong

What Went Well

• Cash runway extended “into the fourth quarter of 2025” on strengthened balance sheet and working capital (+$17.2–$17.5M YoY), de-risking financing ahead of NDA filing .
• Management confidence and regulatory momentum: “We look forward to meeting with the FDA next week, submitting our new drug application this summer, and…bringing to market the first, true, once-daily stimulant medication…” — Shane J. Schaffer, Chairman & CEO .
• Clinical profile: Phase 3 safety reported “no serious treatment emergent adverse events” and consistent safety across nine trials; food-effect results consistent with prior lower-dose study (can be taken with or without food) .

What Went Wrong

• EPS materially missed consensus (-$2.30 actual vs -$1.53 estimate), amid a larger operating loss in Q4 (−$6.21M) vs Q3 (−$3.28M) as late-stage program activities progressed [*S&P Global].
• Quarterly R&D spend rose to $4.33M in Q4 vs $1.43M in Q3 (timing of close-out and analytical activities ahead of NDA), increasing quarterly losses despite full-year R&D decline YoY .
• Pre-commercial status persisted; consensus revenue expected $0.00, underscoring no commercial offset to operating expenses (focus remains on NDA filing and preparedness) [*S&P Global] .

Financial Results

P&L (Quarterly comparison)

Balance Sheet (Quarter-end)

Q4 YoY comparison (selected metrics)

KPIs and Liquidity

Guidance Changes

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available; themes reflect disclosures across earnings releases and 8-Ks.

Management Commentary

• “We look forward to meeting with the FDA next week, submitting our new drug application this summer, and, assuming approval by the FDA, bringing to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day.” — Shane J Schaffer, Chairman & CEO .
• “The safety profile of CTx‑1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials.” — Shane J. Schaffer .
• “Having first-hand experience with Cingulate’s CTx‑1301 product, I am excited for both patients and providers to have this treatment option once approved by the FDA...” — Ann C. Childress, MD (Lead/Primary Investigator for Phase 3 trials) .

Q&A Highlights

No Q4 2024 earnings call transcript was available to extract Q&A themes or clarifications [List: earnings-call-transcript returned none for period Nov 2024–Mar 2025].

Estimates Context

• Q4 2024 EPS: Actual -$2.30 vs Consensus -$1.53 → significant miss. Revenue consensus: $0.00 (pre-commercial). Values retrieved from S&P Global [*S&P Global].

Key Takeaways for Investors

• Liquidity and runway de-risk near-term: cash of $12.21M and runway into Q4 2025 support filing and pre-commercial operations, reducing financing overhang ahead of NDA .
• Regulatory momentum is the core catalyst: Pre‑NDA meeting (Apr 2, 2025) and mid‑2025 NDA filing are the primary stock drivers in the next 1–2 quarters .
• Clinical derisking: robust Phase 3 safety with no serious TEAEs across nine trials strengthens the benefit-risk profile for CTx‑1301 entering review .
• Market access setup favorable: payer study indicates likely coverage through contracting, supporting commercialization prospects post-approval .
• Near-term financial optics: Q4 EPS missed consensus materially; expect continued expense intensity until filing; monitor quarterly OpEx cadence and any updates on licensing to offset cash burn [*S&P Global].
• Strategic options: ongoing licensing exploration (U.S. and ex‑U.S.) could provide non-dilutive capital and commercial leverage .
• Trading lens: upcoming FDA interactions and clarity on submission timing are likely to drive sentiment and volatility; headline risk around regulatory milestones dominates near-term price action .

Additional Supporting Disclosures

• Financing update: $5.48M promissory note ($5M net) in Dec 2024; proceeds for working capital and NDA-related activities .
• European patent issuance for CTx‑1301 (Aug 2024) broadens IP protection across ~30 territories, underpinning ex‑U.S. strategy .

Citations:
- Q4 2024 press release: **[1862150_6f589bb5f4324e708955fd1fc6c5bd9f_0]** **[1862150_6f589bb5f4324e708955fd1fc6c5bd9f_1]** **[1862150_6f589bb5f4324e708955fd1fc6c5bd9f_2]** **[1862150_6f589bb5f4324e708955fd1fc6c5bd9f_3]** **[1862150_6f589bb5f4324e708955fd1fc6c5bd9f_4]** **[1862150_6f589bb5f4324e708955fd1fc6c5bd9f_5]**
- Q4 2024 8‑K/Exhibit: **[1862150_0001641172-25-000689_ex99-1.htm:0]** **[1862150_0001641172-25-000689_ex99-1.htm:1]** **[1862150_0001641172-25-000689_ex99-1.htm:2]**
- Q3 2024 press release and 8‑K: **[1862150_d02780ed7d7f46e1983847378306aebb_0]** **[1862150_d02780ed7d7f46e1983847378306aebb_1]** **[1862150_d02780ed7d7f46e1983847378306aebb_2]** **[1862150_0001493152-24-043915_ex99-1.htm:0]** **[1862150_0001493152-24-043915_ex99-1.htm:2]**
- Q2 2024 press release and 8‑K: **[1862150_64b1586e5cc3487eb79553ff67ce86f8_0]** **[1862150_64b1586e5cc3487eb79553ff67ce86f8_1]** **[1862150_64b1586e5cc3487eb79553ff67ce86f8_2]** **[1862150_64b1586e5cc3487eb79553ff67ce86f8_3]** **[1862150_0001493152-24-031463_ex99-1.htm:1]** **[1862150_0001493152-24-031463_ex99-1.htm:2]**
- Dec 23, 2024 financing press release: **[1862150_37f2e59ef5ff4340be766dc524640cb8_0]**
- Mar 4, 2025 safety press release: **[1862150_56a559ef2c4e4b27bc1a95d138d5ceff_0]**

Disclaimer: Values marked with an asterisk (*) were retrieved from S&P Global.