Executive Summary

Q4 EPS missed S&P Global consensus as OpEx accelerated into pivotal program execution; GAAP EPS was -$0.85 vs S&P “Primary EPS” consensus -$0.71 (miss $0.14), and non-GAAP EPS was -$0.75 vs S&P “EPS Normalized” consensus -$0.67 (miss $0.08). Management attributed higher spend to VIKTORIA-1, the mCRPC study, and VIKTORIA-2 start-up, with R&D up to $33.5M (+85% YoY) and total OpEx $36.4M (+85% YoY) . S&P Global values marked with an asterisk; see disclaimer.
Cash/short-term investments ended at ~$235.1M, with runway to fund current clinical development through 2026; Q4 operating cash burn rose to $27.8M from $20.6M in Q3 and $18.5M in Q4’23 .
2025 is framed as “transformational”: VIKTORIA-1 PIK3CA wild-type topline now guided to Q2 2025 (narrowed), mutant cohort in Q4 2025; VIKTORIA-2 first patient remains Q2 2025; Phase 1b/2 mCRPC preliminary data in late Q2 2025 .
Regulatory path: management plans to request Real-Time Oncology Review (RTOR) post-WT readout and, if not granted, pursue Priority Review, aiming to compress timelines to an NDA submission within ~1–1.5 quarters after topline data .

What Went Well and What Went Wrong

What Went Well
- VIKTORIA-1 execution: PIK3CA wild-type cohort fully enrolled; WT topline guided for Q2 2025; mutant cohort topline Q4 2025 .
- Strategic positioning and tolerability: Company emphasized triplet blockade rationale and favorable discontinuation profile vs single-node PAM inhibitors; stomatitis prophylaxis expected to further reduce AEs in Phase 3 .
- Regulatory and launch readiness: Plan to seek RTOR and potentially Priority Review following WT topline; broad market access rationale favoring IV administration and medical benefit reimbursement category .
What Went Wrong
- Earnings miss driven by spend: GAAP EPS (-$0.85) and non-GAAP EPS (-$0.75) missed S&P Global consensus (-$0.71 Primary; -$0.67 Normalized), as R&D increased to $33.5M and total OpEx to $36.4M, reflecting Phase 3/Phase 1b/2 activity and VIKTORIA-2 commencement . S&P Global values marked with an asterisk; see disclaimer.
- Cash burn inflected: Operating cash outflow rose to $27.8M in Q4 vs $20.6M in Q3 and $18.5M in Q4’23, reflecting program ramp and working capital timing .
- Event-rate opacity: Management declined to detail event accrual status ahead of WT topline, maintaining only the quarter-level timing range, creating near-term uncertainty for traders .

Financial Results

Key P&L and Cash Metrics (oldest → newest)

Metric	Q2 2024	Q3 2024	Q4 2024
R&D Expense ($M)	$22.5	$27.6	$33.5
G&A Expense ($M)	$1.8	$2.5	$3.0
Total Operating Expenses ($M)	$24.3	$30.1	$36.4
GAAP Net Loss ($M)	$23.7	$29.8	$36.7
GAAP EPS	-$0.62	-$0.70	-$0.85
Non-GAAP Adj. Net Loss ($M)	$22.2	$27.6	$32.3
Non-GAAP EPS	-$0.58	-$0.65	-$0.75
Net Cash Used in Ops ($M)	$18.1	$20.6	$27.8
Cash, Cash Eq. & ST Inv. (End) ($M)	$283.1	$264.1	$235.1

Q4 YoY comparison

Metric	Q4 2023	Q4 2024
R&D Expense ($M)	$18.1	$33.5
G&A Expense ($M)	$1.6	$3.0
Total Operating Expenses ($M)	$19.7	$36.4
GAAP Net Loss ($M)	$18.8	$36.7
GAAP EPS	-$0.65	-$0.85
Non-GAAP EPS	-$0.61	-$0.75
Net Cash Used in Ops ($M)	$18.5	$27.8
Weighted Avg Shares (M)	28.9	42.9

Q4 2024 EPS vs S&P Global Consensus

Metric	Actual Q4 2024	S&P Global Consensus Q4 2024	Surprise
GAAP EPS (Primary EPS)	-$0.85	-$0.71*	Miss ($0.14)
Non-GAAP EPS (Normalized)	-$0.75	-$0.67*	Miss ($0.08)
Revenue ($M)	n/a	$0.0*	n/a

Non-GAAP adjustments exclude stock-based comp, non-cash interest expense, and non-cash interest income; reconciling tables provided in the press release .

KPIs

Cash runway: “expected to fund current clinical development program activities through 2026” .
Net operating cash outflow trajectory (Q2→Q3→Q4): $18.1M → $20.6M → $27.8M .

Guidance Changes

Metric/Item	Period	Previous Guidance	Current Guidance	Change
VIKTORIA-1 WT topline	2025	“Late Q1 or Q2 2025” (Q3’24 update)	“Q2 2025”	Narrowed timing
VIKTORIA-1 Mutant topline	2025	“2H 2025” (Q3’24)	“Q4 2025”	Narrowed timing
VIKTORIA-2 first patient	Q2 2025	Q2 2025 (maintained from Q2/Q3)	Q2 2025	Maintained
mCRPC Ph1b/2 preliminary data	Late Q2 2025	1H 2025 (Q2’24)	Late Q2 2025	Narrowed timing
Cash runway	Through 2026	Through 2026 (Q3’24)	Through 2026	Maintained
2025 OpEx cadence	2025	n/a	R&D/G&A: Q4 is a relevant peg; prelaunch activities +~10%	Raised (spend mix)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024)	Trend
Trial timelines (VIKTORIA-1 WT/MT)	WT: late Q4’24–Q1’25; MT: 1H’25 (Q2’24) . Q3 narrowed WT to late Q1/Q2’25; MT 2H’25 .	WT: Q2’25; MT: Q4’25 .	Greater clarity (narrowed windows)
VIKTORIA-2 readiness	Announced; safety run-in 12–36 pts; FPI Q2’25 .	~200 sites selected; FPI Q2’25 affirmed .	Execution progressing
Regulatory path	FDA interactions on VIKTORIA-2 (Q2’24) .	Plan for RTOR; otherwise Priority Review; NDA within ~1–1.5 quarters after topline .	More explicit
Competitive landscape (inavolisib)	Validates PAM pathway; limited to PIK3CA-mutant and metabolically healthy pts (Q2’24), not expected to compress second-line WT opportunity (Q3’24) .	Investigator burden, glucose monitoring; distinct second-line positioning for geda; potential advantage across WT/MT and metabolic status .	Relative positioning strengthened
Tolerability/safety	Low discontinuation, stomatitis prophylaxis expected to help (Q3’24) .	Reiterated tolerability and prophylaxis benefits .	Consistent
Market opportunity	$2B peak with 40% share in second-line if approved (Q3’24) .	Reiterated $2B based on ~30–35k pts, $15–20k/month, 5–12 months duration .	Maintained
Prostate program	Dosed first patient; prelim data 1H’25 (Q2’24) .	Preliminary data late Q2’25; dose optimization focus .	Advancing; clarified
IV administration/reimbursement	IV route seen as advantage in access/adherence (Q3’24) .	Emphasized medical benefit, autonomy, lower OOP costs .	Reinforced

Management Commentary

“We expect 2025 to be a transformational year for Celcuity… including primary analysis for the PIK3CA wild-type cohort of the VIKTORIA-1 trial… topline data in Q2 2025.” — Brian Sullivan, CEO .
“Our view is that the underlying biological drivers… ER, CDK4/6 and PAM… simultaneous blockade… offers the best opportunity to optimize antitumor control.” .
“We would hope to initiate a RTOR request soon after we have our topline data… and… complete the overall package within 1–1.5 quarters after we get our topline data.” .
CFO: “Q4 is a relevant peg… we will continue to increase some kind of prelaunch activities, 10% or so.” .

Additional supportive PR in Q4: SABCS OS data reported median OS 77.3 months in treatment-naïve and 33.9 months post-CDK4/6, favorably comparing to standard regimens; rationale for ER/CDK4/6/PAM triplet strategy .

Q&A Highlights

Event accrual status for WT: management declined specifics; focus remains on Q2 2025 topline timing .
NDA strategy: RTOR request planned; if not, seek Priority Review; submission could start within months of RTOR and complete within ~1–1.5 quarters post-topline .
Topline disclosure scope: expect median PFS per arm and hazard ratios for two primary analyses in WT cohort; full data at next major meeting .
Competitive dynamics: inavolisib’s metabolic monitoring burden and label nuances noted; geda positioned for WT and MT irrespective of metabolic status .
2025 spend cadence: R&D/G&A to roughly track Q4 run-rate with ~10% prelaunch increase .

Estimates Context

Q4 2024 EPS vs S&P Global: GAAP (Primary) EPS -$0.85 vs -$0.71 consensus (miss $0.14); Non-GAAP (Normalized) EPS -$0.75 vs -$0.67 consensus (miss $0.08). Number of estimates: 7 for EPS and revenue . S&P Global values marked with an asterisk; see disclaimer.
Revenue consensus was $0.0, consistent with development-stage profile; no revenue reported in the release .
Implications: Street may need to modestly raise 2025 OpEx and cash burn assumptions given CFO’s commentary on prelaunch spend and the Q4 burn step-up .

Key Takeaways for Investors

Near-term binary catalysts: WT topline in Q2 2025; RTOR/priority review path could compress timelines; mutant cohort topline in Q4 2025 .
Q4 EPS miss reflects deliberate acceleration of pivotal and launch-readiness activities; R&D spend drivers are clear and program-specific .
Cash runway through 2026 provides capacity to reach multiple data readouts without near-term financing, though quarterly burn is rising ($27.8M in Q4) .
Competitive setup may favor geda if WT benefit and tolerability are confirmed; inavolisib label/monitoring burden and population constraints create differentiation .
Expect focus on hazard ratios and PFS deltas at topline; management emphasized HR as more comparable across heterogeneous studies .
VIKTORIA-2 broad, global footprint (~200 sites) positions first-line program for rapid enrollment post safety run-in .
Trading lens: anticipate volatility into WT readout; upside if efficacy/tolerability align with Phase 1b signals and market access thesis; downside if PFS delta/HR underwhelm. Timing clarity reduces event risk drift .

Values with an asterisk were retrieved from S&P Global:

Q4 2024 S&P Global consensus: Primary EPS -$0.7086*, EPS Normalized -$0.67*, Revenue $0.0*, number of estimates: 7* [GetEstimates].

Celcuity Inc. (CELC)·Q4 2024 Earnings Summary