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CI

Celcuity Inc. (CELC)·Q3 2025 Earnings Summary

Executive Summary

  • Non-GAAP EPS beat: Q3 2025 adjusted EPS was $-0.78 vs Wall Street consensus of $-1.01*, while GAAP EPS was $-0.92; OpEx rose as launch prep accelerated .
  • Clinical/regulatory momentum: ESMO late-breaker detailed VIKTORIA-1 WT efficacy (triplet HR=0.24; median PFS 9.3 months) and FDA accepted RTOR pathway; NDA submission remains on track for Q4 2025 .
  • Guidance shift: PIK3CA mutant VIKTORIA-1 topline moved out to late Q1–Q2 2026 from prior “by end of 2025” timeline — a negative surprise .
  • Balance sheet strengthened: $500M upsized term loan (with $350M committed) and Q3-end liquidity of $455M to fund operations through 2027 .
  • Near-term stock catalysts: NDA filing completion (Q4 2025), SABCS subgroup updates, ex-U.S. partnering path, and continued payer/KOL engagement ahead of potential 2026 approval .

What Went Well and What Went Wrong

What Went Well

  • “Potentially practice-changing” VIKTORIA-1 WT efficacy with triplet reducing risk of progression/death by 76% (HR=0.24) and doublet by 67% (HR=0.33); median PFS 9.3 and 7.4 months vs 2.0 months for fulvestrant .
    Quote: “We presented potentially practice-changing safety and efficacy results...” — Brian Sullivan, CEO .
  • RTOR accepted; NDA submission for WT cohort “on track to be completed during the fourth quarter of 2025” — accelerates review timeline .
  • Launch readiness: commercial organization largely in place; robust payer and KOL engagement; CFO reiterated funding through 2027 supported by upsized debt and warrant exercises .

What Went Wrong

  • Timeline delay: PIK3CA mutant cohort topline shifted to late Q1–Q2 2026 (from Q2 guidance of “by end of 2025”), likely tempering multi-cohort momentum .
  • Higher OpEx: Q3 R&D $34.9M and G&A $7.9M, with G&A up $5.4M YoY driven by $4.0M non-cash SBC and commercialization build-out; cash used in ops $44.8M vs $20.6M YoY .
  • Q2 miss: prior quarter non-GAAP EPS ($-0.93) was modestly below consensus ($-0.88*), showing near-term estimate friction amid scaling .

Financial Results

EPS vs Prior Periods and Estimates

MetricQ1 2025Q2 2025Q3 2025
GAAP Net Loss per Share ($)-0.86 -1.04 -0.92
Non-GAAP Adjusted EPS ($)-0.81 -0.93 -0.78
Primary EPS Consensus Mean ($)*-0.86-0.88-1.01

Values retrieved from S&P Global.*

Q3 EPS beat: Non-GAAP $-0.78 vs $-1.01* consensus. Q2 miss: Non-GAAP $-0.93 vs $-0.88*. Q1 slight beat: Non-GAAP $-0.81 vs $-0.86*.

Operating Expenses

Metric ($USD Millions)Q1 2025Q2 2025Q3 2025
R&D32.227 40.222 34.915
G&A3.906 3.787 7.934
Total OpEx36.133 44.009 42.849

YoY comparators: Q3 2024 R&D $27.588 , G&A $2.472 , Total OpEx $30.060 .

Cash Flow and Liquidity

Metric ($USD Millions)Q1 2025Q2 2025Q3 2025
Net Cash Used in Operating Activities35.9 36.2 44.8
Cash, Cash Equivalents & Short-term Investments (quarter-end)205.7 168.4 455.0

Note: Q3 liquidity reflects mid-year financing, debt draw and warrant exercises .

Revenue

Metric ($USD Millions)Q1 2025Q2 2025Q3 2025
Revenue (Actual)0.0 0.0 0.0
Revenue Consensus Mean ($)*0.00.00.0

Values retrieved from S&P Global.*

KPIs (Clinical Efficacy & Safety)

KPIData
VIKTORIA-1 WT Triplet: HR, Median PFS vs controlHR=0.24; 9.3 vs 2.0 months (+7.3 months)
VIKTORIA-1 WT Doublet: HR, Median PFS vs controlHR=0.33; 7.4 vs 2.0 months (+5.4 months)
ORR and DOR (Triplet vs fulvestrant)ORR 32% vs 1%; DOR 17.5 months
ORR and DOR (Doublet)ORR 28%; DOR 12.0 months
Safety (select Grade 3 TRAEs)Neutropenia 52.3% (triplet), 0% (doublet), 0.8% (fulvestrant); Stomatitis 19.2%/12.3%/0%; Rash 4.6%/5.4%/0%; Hyperglycemia 2.3%/2.3%/0%
Discontinuation due to TRAEs2.3% (triplet), 3.1% (doublet)
Interim OS trend (hazard ratio)~0.69 triplet; ~0.69 doublet (favorable trend)
mCRPC Phase 1b (gedatolisib + darolutamide)6-mo rPFS 67%; median rPFS 9.1 months (combined arms); Arm 120mg: 74%/9.5 months; Arm 180mg: 61%/7.4 months

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Gedatolisib NDA (WT cohort)Q4 2025Submit in Q4 2025 On track to complete NDA submission in Q4 2025 Maintained
VIKTORIA-1 PIK3CA Mutant toplinePrior: Q4 2025Topline by end of 2025 Topline in late Q1 2026 or Q2 2026 Lowered/Delayed
VIKTORIA-2 (first-line, endocrine-resistant)2025 progressFirst patient dosed July; enrollment ongoing Enrollment ongoing; timelines intact Maintained
Cash runwayThrough 2027Expect funding through 2027 (pro forma) Expect funding through 2027 Maintained
Term loan facility sizeOngoingExisting facility; no upsized detail in Q2 Increased to $500M; $350M committed; $30M Term D drawn Raised
Regulatory pathway (RTOR)2025Not disclosed priorFDA accepted RTOR submission plan for WT NDA Improved

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3 2025)Trend
Clinical efficacy (WT cohort)Anticipated WT topline Q3 2025 ; Positive WT topline announced in July with unprecedented HR/PFS ESMO detailed ORR/DOR; favorable subgroup PFS (US/Canada 19.3m triplet; 14.9m doublet) Strengthening
Regulatory/legalQ2: New gedatolisib dosing patent, exclusivity to 2042 RTOR accepted; NDA submission on track for Q4 Improving
PIK3CA mutant cohortQ1/Q2: topline by Q4 2025 Timeline pushed to late Q1–Q2 2026 Softening
Commercial launch prepBuilding infrastructure; financing to support Org mostly hired (ex-field); payer and KOL engagement robust Accelerating
Market size & pricingNot quantified priorTAM $5–$6B; potential peak revenues $2.5–$3B; pricing comps ~$25k WAC with 20% gross-to-net for medical benefit drugs More explicit
Overall survivalNot discussedInterim OS HR ~0.69 favorable; high bar for second-line OS Emerging
Ex-U.S. strategyNot discussedPlan to partner ex-U.S.; MAA filing post-mutant sNDA; alignment with Japanese authority Clarifying

Management Commentary

  • “We remain on track to submit the New Drug Application for gedatolisib later this year based on data from the PIK3CA wild-type cohort.” — Brian Sullivan, CEO .
  • “The hazard ratios for both the gedatolisib triplet and doublet are more favorable than have ever been reported by any phase III trial for patients with HR positive, HER2 negative, ABC.” — Brian Sullivan .
  • “We began laying the groundwork for a potential gedatolisib launch 18 months ago... Except for the field salesforce, we've mostly completed hiring.” — Brian Sullivan .
  • “We expect cash, cash equivalents, investments, and drawdowns on our current debt facility to fund operations through 2027.” — Vicky Hahne, CFO .

Q&A Highlights

  • Data updates: Expect SABCS presentation with additional subgroup analyses (e.g., ESR1 subsets) .
  • RTOR/NDA scope: WT NDA submission is separate; potential RTOR for mutant depends on data clarity and SOC potential .
  • Duration and pricing: U.S. triplet PFS subgroup 19.3 months; pricing comps around $25k WAC with ~20% medical benefit gross-to-net; pricing research ongoing .
  • Ex-U.S. commercialization: U.S.-led launch; ex-U.S. partner(s) targeted post-mutant sNDA/MAA; alignment with EU/Japan authorities .
  • OS/regulatory: Interim OS HR ~0.69 supports submission; recognizes difficulty of second-line OS endpoint .
  • Manufacturing: Multi-site flexible supply strategy; emphasis on resiliency .

Estimates Context

  • Q3 2025 Non-GAAP EPS beat: $-0.78 vs consensus $-1.01*; Q2 miss ($-0.93 vs $-0.88*); Q1 beat ($-0.81 vs $-0.86*). Primary EPS estimate counts rose from 6 to 8 across Q1–Q3, indicating increasing coverage.*
  • Revenue estimates are $0 across Q1–Q3 and FY25, consistent with pre-commercial status.*
  • FY 2025 Primary EPS consensus: $-3.72*, reflecting elevated OpEx into launch prep; upside risk if commercialization timelines hold and spending normalizes post-NDA.*

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Strong efficacy profile in WT cohort with best-in-class HR/PFS and compelling ORR/DOR supports the NDA and commercial case; RTOR acceptance is a noteworthy regulatory de-risking event .
  • Significant EPS beat in Q3 on non-GAAP basis despite higher G&A as commercialization ramps; watch OpEx trajectory and SBC effects on GAAP EPS .
  • Mutant cohort delay to late Q1–Q2 2026 is the main negative; it likely pushes multi-cohort labeling optionality and partnering timelines out a few months .
  • Liquidity and debt capacity are sufficient to bridge to potential 2026 approval and launch; runway guided through 2027 amid stepped-up launch investment .
  • Pricing and TAM commentary ($5–$6B) plus medical-benefit gross-to-net dynamics suggest attractive net pricing potential vs oral comparators; early payer/KOL feedback favorable .
  • Near-term catalysts: NDA filing completion (Q4), SABCS subgroup data, further payer/KOL traction, and VIKTORIA-2 enrollment updates; medium-term: mutant topline, ex-U.S. partnering, MAA filings .
  • Monitoring items: OS trend maturation, safety profile in broader practice, VIKTORIA-2 progress, and any changes to launch staffing or timelines that could impact spend and EPS trajectory .