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CI

Cingulate Inc. (CING)·Q3 2025 Earnings Summary

Executive Summary

  • FDA accepted the NDA for lead ADHD candidate CTx-1301; PDUFA target action date set for May 31, 2026, marking a critical regulatory inflection ahead of potential mid-2026 launch .
  • Q3 2025 net loss was $7.34M, widening from $4.13M in Q3 2024, driven by higher R&D (+99.5% YoY) and G&A (+69.7% YoY) tied to NDA submission, manufacturing readiness, and commercial preparation .
  • Cash was $6.12M with working capital of $1.55M at quarter-end; management guides runway into Q2 2026 but expects to raise ~$7.0M incremental capital to bridge to the PDUFA date and commercialization activities .
  • Strategic readiness advanced via exclusive U.S. commercial supply agreement with Bend Bio Sciences (through 2028, subject to approval) and $4.3M PDUFA filing fee waiver; post-quarter financing of $6.0M (9% unsecured note, 18-month maturity) supports near-term operations .

What Went Well and What Went Wrong

What Went Well

  • NDA acceptance and firm PDUFA date established clear regulatory path; management emphasized momentum: “Cingulate has made meaningful progress this quarter toward key value-creating milestones…” (Jay Roberts, Executive Chairman) .
  • Manufacturing readiness de-risked: Exclusive commercial supply agreement with Bend Bio Sciences for U.S. supply through 2028, aligning capacity ahead of launch .
  • Non-dilutive and strategic financial wins: $4.3M FDA PDUFA fee waiver plus $6.0M post-quarter financing bolster liquidity to support pre-commercial activities .

What Went Wrong

  • Operating loss expanded to $6.00M and net loss to $7.34M in Q3 as R&D ($2.85M) and G&A ($3.15M) rose due to NDA-related costs, manufacturing preparation, and commercial build-out .
  • Working capital declined to $1.55M and cash to $6.12M, increasing near-term financing dependence into mid-2026 .
  • EPS missed consensus across Q1–Q3, reflecting elevated operating spend without revenue offset; Q3 EPS was a significant miss versus S&P Global consensus (details in Estimates Context)*.

Financial Results

Operating Metrics (Quarterly)

MetricQ1 2025Q2 2025Q3 2025
Research & Development ($USD)$2,222,626 $2,700,939 $2,848,544
General & Administrative ($USD)$1,483,409 $1,949,035 $3,147,291
Operating Loss ($USD)$(3,706,035) $(4,649,974) $(5,995,835)
Net Loss ($USD)$(3,802,691) $(4,788,735) $(7,341,062)

Balance and Liquidity (Quarterly)

MetricQ1 2025Q2 2025Q3 2025
Cash and Cash Equivalents ($USD)$9,518,966 $8,900,183 $6,118,710
Working Capital ($USD)$4,889,902 $3,489,921 $1,551,025
Total Assets ($USD)$12,469,588 $13,468,208 $10,518,892
Total Liabilities ($USD)$6,538,768 $7,956,334 $7,045,206
Total Stockholders’ Equity ($USD)$5,930,820 $5,511,874 $3,473,686

YoY Comparison (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025YoY Change
R&D ($USD)$1,428,504 $2,848,544 +$1,420,040 (+99.5%)
G&A ($USD)$1,853,583 $3,147,291 +$1,293,708 (+69.7%)
Operating Loss ($USD)$(3,282,087) $(5,995,835) $(2,713,748) (−82.7%)
Net Loss ($USD)$(4,125,643) $(7,341,062) $(3,215,419) (−78.0%)

EPS and Revenue vs Estimates (S&P Global)*

MetricQ1 2025Q2 2025Q3 2025
Diluted EPS – Actual ($)$(1.04)*$(1.09)*$(1.35)*
Diluted EPS – Consensus Mean ($)$(0.98)*$(0.8225)*$(0.752)*
EPS Outcome vs ConsensusMiss*Miss*Miss*
Revenue – Actual ($)N/AN/AN/A
Revenue – Consensus Mean ($)$0.00*$0.00*$0.00*
Revenue Outcome vs ConsensusN/AN/AN/A

Values marked with an asterisk are retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayQ1 2025Runway into Q4 2025 Runway into Q2 2026 Raised duration
Incremental Capital NeedsQ2 2025~$1.5M to advance commercialization into early 2026 ~$7.0M to bridge through May 31, 2026 PDUFA and commercialization efforts Raised
Manufacturing SupplyQ2 2025Not disclosedExclusive U.S. commercial manufacturer (Bend Bio Sciences) through 2028, subject to approval Established
Regulatory Filing CostsQ2 2025Not disclosed$4.3M FDA PDUFA fee waiver (FY2025) Positive cost relief
FinancingQ2 2025LPC equity purchase agreement up to $25M available over 36 months $6.0M unsecured promissory note, 9% interest, 18-month maturity; redemption flexibility post-PDUFA Added debt facility

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not found; themes are derived from press releases and 8-Ks.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory MilestonesPre-NDA meeting completed; mid-2025 NDA target; positive Phase 3 safety; food-effect study support NDA accepted; PDUFA May 31, 2026 Progressing on schedule; risk narrowed toward review phase
Manufacturing ReadinessCMC packages prepared; scale-up implied via NDA prep Exclusive U.S. commercial supply agreement (Bend Bio Sciences) through 2028 Readiness strengthened; supply chain de-risked
Commercial Build-outEarly pre-commercial activities; LPC equity facility to fund readiness CCO hire (Bryan Downey); post-Q3 $6M financing; Indegene omnichannel described in NDA acceptance PR Acceleration in commercial preparation
Liquidity & CapitalCash $9.52M; WC $4.89M Cash $6.12M; WC $1.55M; ~$7M raise needed; $4.3M fee waiver reduces cash burn Liquidity tightened; financing plan articulated
Clinical DifferentiationPositive adult/pediatric data; once-daily profile; fed/fast flexibility Phase 3 data highlighted at AACAP; once-daily PTR positioning reinforced Consistent clinical narrative; durability emphasized

Management Commentary

  • “The FDA’s acceptance of our NDA for CTx-1301, the appointment of an experienced commercial leader in Bryan Downey, and the completion of a $6 million financing collectively strengthen our position as we advance toward a potential 2026 launch.” — Jay Roberts, Executive Chairman .
  • “FDA acceptance of our NDA marks a defining milestone for Cingulate… positions Cingulate to transition from a development-stage to a commercial-stage company in 2026, pending FDA approval of CTx-1301.” — Jay Roberts .
  • “Our adult and pediatric studies consistently demonstrated rapid symptom relief, sustained performance and the flexibility of dosing with or without food—attributes that we believe will resonate strongly with both physicians and patients.” — Matt Brams, MD, Chief Medical Officer .

Q&A Highlights

  • No Q3 2025 earnings call transcript was found; no Q&A themes or guidance clarifications available from a call [ListDocuments result: none].
  • Key investor topics addressed via press releases: NDA acceptance and timelines , manufacturing exclusivity , financing and cash runway .

Estimates Context

  • EPS missed S&P Global consensus in Q1–Q3 as operating costs rose ahead of potential commercialization; Q3 EPS was a material miss (actual $(1.35)* vs consensus $(0.752)*) driven by higher R&D and G&A associated with NDA submission, manufacturing validation, contingent bonuses, and commercial preparation . Values marked with an asterisk are retrieved from S&P Global.
  • Revenue consensus was $0 across all quarters, consistent with the pre-revenue stage*. Following NDA acceptance, sell-side models may re-time commercialization cash burn and refine pre-launch spend assumptions; EPS estimates likely to incorporate ongoing OpEx into PDUFA date*.

Key Takeaways for Investors

  • Regulatory risk reduced with NDA acceptance and PDUFA date set; next catalyst is mid-2026 approval decision .
  • Liquidity is the near-term swing factor: cash $6.12M, WC $1.55M, ~$7M incremental capital need to reach PDUFA and launch preparation; recent $6M note provides partial bridge .
  • Operating spend inflecting as the company transitions to commercialization (R&D + G&A increases tied to NDA, manufacturing, and commercial build) — a likely driver of EPS misses vs consensus* .
  • Manufacturing de-risked via exclusive Bend Bio Sciences agreement through 2028, supporting launch readiness if approved .
  • The $4.3M PDUFA fee waiver meaningfully reduces near-term cash outflows and extends runway .
  • Post-acceptance commercial strategy build-out (CCO appointment; Indegene platform) positions the company for payer access and prescriber reach post-approval .
  • Trading lens: stock narrative sensitive to financing cadence, regulatory review progress, and visibility into commercialization costs; expect estimate revisions to track OpEx and funding milestones*. Values marked with an asterisk are retrieved from S&P Global.