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CI

Cingulate Inc. (CING)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was a pivotal execution quarter: Cingulate completed its Pre‑NDA meeting, reiterated the NDA submission for CTx‑1301 in mid‑2025, and highlighted positive food‑effect and pediatric Phase 3 efficacy readouts, while cash stood at $9.5M with runway into Q4 2025 .
  • EPS of −$1.04 missed Wall Street consensus of −$0.98 by $0.06; the company remains pre‑revenue; operating expenses increased YoY as personnel salaries were reinstated and regulatory work intensified ahead of the NDA filing * [functions.GetEstimates]* .
  • Strategic updates included a $3.0M non‑dilutive grant to accelerate CTx‑2103 (buspirone) with IND targeted mid‑2026, and FDA alignment on CTx‑1301 filing expectations (including post‑approval stability commitments and a scientific bridge to Focalin XR) .
  • Near‑term stock catalysts: formal NDA submission this summer, additional detail from FDA minutes (shelf‑life expectations), and continued clinical/regulatory progress for CTx‑1301; medium‑term, grant‑funded CTx‑2103 development milestones and potential licensing discussions may de‑risk funding needs .

What Went Well and What Went Wrong

What Went Well

  • Pre‑NDA meeting completed; FDA minutes aligned with the company’s NDA plan for CTx‑1301, supporting a summer 2025 submission: “We are pleased that the feedback we received from our pre‑NDA meeting with the FDA is aligned with our plans to submit a new drug application for CTx‑1301 this summer” — CEO Shane J. Schaffer .
  • Clinical momentum: positive food‑effect study at 50mg indicates dosing “with or without food” and pediatric Phase 3 fixed‑dose study achieved statistically significant improvements with robust effect sizes (0.737–1.185) within 5 weeks .
  • Non‑dilutive funding: $3M grant to advance CTx‑2103 through mid‑2026 and toward IND; staged payments tied to development milestones, with contingent royalty capped at $3.5M .

What Went Wrong

  • EPS missed consensus by $0.06 as elevated R&D and G&A (personnel reinstatement and regulatory preparation) lifted operating loss; net loss rose to $3.8M vs $3.0M YoY * .
  • Working capital fell sequentially to $4.9M from $7.7M, primarily due to cash usage to support operations despite capital raised during the quarter .
  • Pre‑commercial profile persists (no product revenue), keeping funding and regulatory execution as core risks; prior quarter evidence of financing needs and capital structure actions (e.g., warrant inducement, reverse split) remained part of the backdrop .

Financial Results

Headline Metrics (USD, Millions except per‑share)

MetricQ3 2024Q4 2024Q1 2025
Cash and Cash Equivalents ($)$10.04 $12.21 $9.52
Working Capital ($)$9.80 $7.54 $4.89
R&D Expense ($)$1.43 $4.33 $2.22
G&A Expense ($)$1.85 $1.88 $1.48
Net Loss ($)$3.23 $6.13 $3.80
Diluted EPS ($)N/A−1.86*−1.04

Notes: Values with asterisks retrieved from S&P Global.*

EPS vs Wall Street Consensus and Surprise (Q1 2025)

MetricQ1 2025
Consensus EPS ($)−0.98*
Actual EPS ($)−1.04
Surprise ($)−0.06*
Surprise (%)−6.1%*
EPS # of Estimates2*

Notes: Values with asterisks retrieved from S&P Global.*

Revenue vs Wall Street Consensus (Q1 2025)

MetricQ1 2025
Consensus Revenue ($)$0.00*
Actual Revenue ($)N/A (pre‑revenue)
Revenue # of Estimates3*

Notes: Values with asterisks retrieved from S&P Global.*

Segment Breakdown

  • Not applicable (pre‑commercial, no reported product revenue) .

KPIs and Balance Sheet Indicators

KPIQ3 2024Q4 2024Q1 2025
Cash RunwayInto Q3 2025 Into Q4 2025 Into Q4 2025
Total Assets ($M)$13.58 $14.86 $12.47
Total Liabilities ($M)$1.54 $7.41 $6.54
Stockholders’ Equity ($M)$12.04 $7.46 $5.93
Accumulated Deficit ($M)$(102.36) $(108.49) $(112.29)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
CTx‑1301 NDA Submission TimingMid‑2025“Targeted 1H 2025” (Aug 2024) “Summer 2025” (aligned post Pre‑NDA minutes) Maintained/refined (calendar specificity)
Cash RunwayThrough Q4 2025“Runway into Q4 2025” (FY24 update) “Into Q4 2025” (Q1 reiteration) Maintained
CTx‑2103 (buspirone) DevelopmentThrough mid‑2026N/A$3M grant; staged payments; IND targeted mid‑2026 New guidance (funding/development milestones)
CTx‑1301 Shelf‑Life ExpectationLaunchN/AExpect 24 months shelf‑life; post‑approval stability commitment for intermediate doses New detail (regulatory expectation)

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available; themes tracked via press releases across quarters.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Regulatory: NDA path for CTx‑1301Final food‑effect study initiated; targeting mid‑2025 NDA In‑person Pre‑NDA scheduled Apr 2; mid‑2025 NDA targeted Pre‑NDA completed; FDA minutes aligned; NDA “this summer” Progressing per plan
Clinical: Safety/EfficacyR&D down on reduced clinical activity Final Phase 3 safety data highlighted (no serious TEAEs) 50mg food‑effect positive; pediatric Phase 3 efficacy significant (effect sizes up to 1.185) Strengthening dataset
ManufacturingRegistration batches completed Registration batches referenced; NDA prep Shelf‑life expectation 24 months at launch Advancing toward commercialization
Financing/Liquidity~$12.5M raised; runway into Q3 2025 Working capital +$17.5M YoY; runway into Q4 2025 Cash $9.5M; runway into Q4 2025; working capital fell to $4.9M Stable runway; lower WC
Licensing & PayerExploring licensing; payer study suggests coverage potential Licensing exploration; payor study reaffirmed Continuing to explore licensing; PTR platform highlighted Ongoing BD optionality
Listing/CorporateRegained Nasdaq bid price compliance Capital actions (ATM, warrants, debt) detailed Non‑dilutive $3M grant for anxiety program Incremental de‑risking
Anxiety Program (CTx‑2103)N/AN/AGrant funding and development plan through mid‑2026; IND targeted Initiated funding path

Management Commentary

  • “We held a productive meeting with the FDA last month and remain on target to file an NDA in the middle of the year for our lead ADHD asset CTx‑1301.” — Shane J. Schaffer, Chairman & CEO .
  • “We are pleased that the feedback we received from our pre‑NDA meeting with the FDA is aligned with our plans to submit a new drug application for CTx‑1301 this summer.” — Shane J. Schaffer .
  • “CTx‑1301 demonstrated statistically significant improvements in ADHD symptoms across all fixed doses, achieving robust effect sizes (0.737 to 1.185) within 5 weeks.” — Raul R. Silva, MD, Chief Science Officer .
  • “We were also pleased to receive a $3 million grant of non‑dilutive funding for the development of CTx‑2103 for the treatment of anxiety.” — Shane J. Schaffer .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; thus, no Q&A themes or clarifications can be cited from a call this quarter [functions.ListDocuments].

Estimates Context

  • EPS: −$1.04 vs Wall Street consensus −$0.98 (miss of $0.06; −6.1%); two estimates in the quarter. Cingulate remains pre‑revenue; revenue consensus at $0.00 [functions.GetEstimates]* .
  • With operating costs elevated by regulatory preparation and personnel reinstatement, estimates may modestly drift higher on near‑term opex; catalysts around the NDA filing could drive renewed coverage and model updates *.

Notes: Values marked with asterisks retrieved from S&P Global.*

Key Takeaways for Investors

  • The NDA filing for CTx‑1301 is the central near‑term catalyst: FDA alignment and summer submission timing increase execution confidence; monitor formal filing and any acceptance/RD review milestones .
  • Clinical risk appears reduced: positive pediatric efficacy and food‑effect results complement consistent safety across studies; strengthens the eventual label discussion if approved .
  • Funding picture: cash runway into Q4 2025 and the $3M non‑dilutive grant for CTx‑2103 extend development capacity; licensing remains a lever to further de‑risk capital needs .
  • Pre‑commercial status persists: EPS miss driven by opex; expect continued volatility around financing strategy, regulatory news flow, and street estimate resets .
  • Platform upside: FDA minutes suggest a scientific bridge to Focalin XR and 24‑month shelf‑life expectations; PTR™ could underpin broader pipeline optionality post‑CTx‑1301 approval .
  • Trading implications: stock likely sensitive to step‑wise regulatory updates (NDA submission/acceptance) and any BD/licensing disclosures; near‑term flows may pivot on de‑risking signals rather than fundamentals given pre‑revenue profile .
  • Medium‑term thesis: approval/launch trajectory of CTx‑1301 and IND progress for CTx‑2103 set the stage for value creation; payer study findings and shelf‑life guidance may support commercial readiness and contracting .

References: Q1 2025 press release & Form 8‑K ; FDA minutes press release ; Phase 3 pediatric efficacy ; Pre‑NDA meeting ; Safety results ; Prior quarter Q4/FY release & 8‑K ; Q3 2024 8‑K .