Executive Summary

Celcuity reported a larger net loss on higher R&D as it advanced gedatolisib, while delivering pivotal VIKTORIA-1 PIK3CA wild-type topline data showing unprecedented hazard ratios (HR 0.24 triplet; HR 0.33 doublet) and PFS increments (7.3 and 5.4 months) vs fulvestrant, positioning for an NDA in Q4 2025 .
GAAP EPS of $(1.04) missed S&P Global consensus EPS of $(0.88)*; non-GAAP adjusted EPS $(0.93) was slightly below consensus as well, with no revenue recognized (pre-commercial stage) .
Liquidity materially improved: Q2-end cash/investments were $168.4M; pro forma cash of ~$455M after July/Aug financing extends runway through 2027; management also flagged access to another ~$116M (term loan + in-the-money warrants) .
Near-term catalysts: full VIKTORIA-1 WT data (later 2025), PIK3CA-mutant cohort topline by end-2025, NDA submission (RTOR rolling start in September, completion targeted Q4 2025), and first patient dosed in VIKTORIA-2 (front-line) .

What Went Well and What Went Wrong

What Went Well
- Pivotal efficacy: VIKTORIA-1 WT cohort met both primary endpoints with unprecedented hazard ratios and PFS improvements vs control; CEO: “topline data… are potentially practice-changing” .
- Regulatory momentum: FDA agreed to RTOR; rolling NDA submission to initiate September; completion targeted for Q4 2025 .
- Balance sheet and IP: $286.5M net proceeds from July/August offerings; new dosing-regimen patent extends exclusivity to 2042; CFO reiterated funding into 2027 .
What Went Wrong
- Operating spend and losses surged: Q2 OpEx rose to $44.0M (+81% y/y), driven by R&D (incl. $5M milestone under Pfizer license), widening GAAP net loss to $45.3M .
- Cash burn increased: net cash used in operating activities was $36.2M vs $18.1M in Q2 2024; pre-commercial model remains revenue-free .
- Data/visibility gaps: full safety details (e.g., grade-specific TEAEs, subgroup analyses) reserved for upcoming conferences; investors await PIK3CA-mutant cohort benchmarks (management pointed to Capivasertib ~5.5m mPFS as practical comparator) .

Financial Results

Reported metrics; $USD Millions except per-share.

Metric	Q2 2024	Q1 2025	Q2 2025
Revenues	— (no revenue reported)	— (no revenue reported)	— (no revenue reported)
Total Operating Expenses ($)	$24.3	$36.1	$44.0
R&D Expense ($)	$22.5	$32.2	$40.2
G&A Expense ($)	$1.8	$3.9	$3.8
Net Loss ($)	$23.7	$37.0	$45.3
GAAP Diluted EPS ($)	$(0.62)	$(0.86)	$(1.04)
Non-GAAP Adjusted Net Loss ($)	$22.2	$34.7	$40.5
Non-GAAP Adjusted EPS ($)	$(0.58)	$(0.81)	$(0.93)
Net Cash Used in Operating Activities ($)	$18.1	$35.9	$36.2
Cash, Cash Equivalents & Short-term Investments ($)	—	$205.7	$168.4
Pro Forma Cash, Cash Equivalents & ST Investments ($)	—	—	~$455.0

Clinical efficacy highlights (VIKTORIA-1 PIK3CA wild-type, BICR):

Regimen vs Fulvestrant	Hazard Ratio	Median PFS (months)	Incremental PFS vs Control
Gedatolisib + Palbociclib + Fulvestrant (Triplet)	0.24	9.3	+7.3
Gedatolisib + Fulvestrant (Doublet)	0.33	7.4	+5.4

Actual vs S&P Global Consensus (Q2 2025):

Metric	Actual	Consensus
GAAP EPS ($)	$(1.04)	$(0.884)*
Non-GAAP Adjusted EPS ($)	$(0.93)	$(0.884)*
Revenue ($)	— (no revenue reported)	$0*

Values with * are retrieved from S&P Global.

Segment breakdown: Not applicable (no commercial revenue segments reported) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VIKTORIA-1 WT Topline	2025	Q3 2025 expected	Reported July 28, 2025	Achieved
NDA Submission (WT data)	2025	If positive WT data, target Q4 2025	RTOR accepted; rolling start Sept; completion targeted Q4 2025	Maintained; process accelerated (RTOR)
VIKTORIA-1 PIK3CA Mutant Topline	2025	Q4 2025	End of 2025 timeline reaffirmed	Maintained
VIKTORIA-2 First Patient	2025	Dose first patient in Q2 2025	First patient dosed July 24, 2025	Achieved
Cash Runway	Multi-year	Fund program through 2026	Pro forma cash funds operations through 2027	Raised
Patent Exclusivity (gedatolisib dosing)	U.S.	—	New patent extends exclusivity into 2042	New positive

Earnings Call Themes & Trends

Topic	Q4 2024 (Q-2)	Q1 2025 (Q-1)	Q2 2025 (Current)	Trend
Pivotal efficacy (VIKTORIA-1)	WT cohort fully enrolled; topline data expected Q2 2025	WT topline expected Q3 2025 (timeline shift with event rates)	WT topline positive with unprecedented HR/PFS; full data later 2025	Strongly positive
Regulatory path	—	NDA if WT positive	RTOR accepted; rolling NDA in Sept; completion Q4 2025	Accelerating
Safety profile	Phase 1b safety discussed at SABCS	—	Favorable tolerability vs Phase 1b; detailed rates to be presented later	Improving; details pending
Commercial readiness	—	Building commercial leadership/team	Scaling for launch (market access, sales infrastructure)	Advancing
Market size/opportunity	—	—	~34k 2L HR+/HER2- patients; ~60% WT; ~$5B TAM projection	Clearer sizing
Financing/liquidity	$235.1M YE cash/investments	$205.7M cash/investments	$286.5M net proceeds; pro forma ~$455M; runway to 2027; +$116M potential access	Strengthened
IP	—	—	New dosing-regimen patent to 2042	Strengthened
Pipeline beyond breast (mCRPC; HER2+ mBC)	—	CELC-G-201 topline 1b in late Q2 2025	Preliminary 1b mCRPC data: 6-mo rPFS 66%; HER2+/PIK3CA mBC ORR 43%	Positive early signals

Management Commentary

CEO strategic message: “We believe topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing… We are on track to submit the [NDA]… later this year” .
Market positioning: “We estimate there are 34,000 patients moving to second line… roughly 60% are PIK3CA wild type… addressable market potential… roughly $5,000,000,000” .
Commercial readiness: “We began building our team last year… we’re scaling infrastructure… benchmarked with leaders who have launched first company drugs” .
CFO liquidity: “Pro forma… cash… approximately $455,000,000… plus ~$116,000,000 potential… fund operations through 2027” .

Notable quotes:

“The reported hazard ratios and improvements in median PFS are unprecedented in HR+/HER2- advanced breast cancer.” — Brian Sullivan .
“We are pleased that the FDA agreed to review our NDA… under the RTOR program… rolling submission… completion… Q4 2025.” — Brian Sullivan .
“The overall response rate was 43%… no patients discontinued gedatolisib due to a treatment-related adverse event” (HER2+/PIK3CA mBC Phase 2) — Company summary .

Q&A Highlights

Subgroup/safety disclosures: Full PIK3CA WT subgroup and detailed safety to be presented at upcoming meetings; initial data focused on primary endpoints .
PIK3CA-mutant cohort benchmarks: Management views alpelisib as control; ~7–8m outcome expected historically; capivasertib (~5.5m mPFS post-CDK) seen as practical comparator in real-world decision-making .
BICR vs investigator-read: BICR chosen for open-label design; high concordance historically; sensitivity analyses support robustness for NDA .
Launch strategy: Self-launch planned; scaling sales/market access; infrastructure build sequenced to anticipated approval/launch timeline .
Doublet vs triplet use: Triplet maximizes PFS; doublet offers option where myelosuppression is a concern; future subgroup data may guide selection .

Estimates Context

S&P Global consensus Primary EPS for Q2 2025 was $(0.884)* vs GAAP EPS $(1.04) and non-GAAP $(0.93), a modest miss on both bases; revenue consensus was $0* (pre-commercial) .
Forward consensus infers continued operating losses as development scales; target price consensus stood at ~$103.56* around the period. Values with * are retrieved from S&P Global.