Executive Summary

Celcuity reported a larger Q1 net loss as R&D ramped for three late-stage programs, but reiterated a robust cash runway into 2026 and outlined multiple 2025 data catalysts; notably, the VIKTORIA‑1 PIK3CA wild-type topline shifted to Q3 2025 from Q2 due to blinded event timing, while mutant topline remains Q4 2025 .
GAAP net loss per share was $0.86 vs. $0.64 a year ago; non‑GAAP EPS was $0.81 vs. $0.59 YoY as R&D rose to $32.2M on trial execution and hiring; operating cash use increased to $35.9M in Q1 (vs. $17.1M) .
Cash, cash equivalents and investments ended at $205.7M, with management expecting funding for current clinical development activities through 2026 .
Near‑term stock reaction catalysts: VIKTORIA‑1 WT topline readout in Q3 2025 and prostate CELC‑G‑201 Phase 1b topline late Q2 2025; both were reiterated on the call .

What Went Well and What Went Wrong

What Went Well

Clear 2025 catalyst calendar: VIKTORIA‑1 WT topline expected Q3 2025; mutant cohort topline Q4 2025; CELC‑G‑201 Phase 1b topline late Q2 2025; VIKTORIA‑2 first patient dosing in Q2 2025 .
Strategic positioning and potential market size: management estimates ~200,000 late‑stage cancer patients globally could be eligible for gedatolisib if approved, underlining commercial potential; CEO: “If our topline data from the WT cohort is positive, we expect the data will support the filing of our first new drug application and, if approved, our transition to a commercial stage company.” .
Balance sheet visibility: $205.7M cash/investments and expectation to fund current clinical development activities through 2026 supports execution through key readouts .

What Went Wrong

Timing slip: VIKTORIA‑1 WT topline moved from Q2 2025 to Q3 2025, driven by distribution of progression events across arms; management cited reduced variability risk now that event thresholds are near .
Higher cash burn: Net cash used in operating activities rose to $35.9M (vs. $17.1M) as trial activity and headcount expanded, increasing quarterly cash draw .
Wider quarterly loss: GAAP net loss was $37.0M (vs. $21.6M YoY) and non‑GAAP adjusted net loss was $34.7M (vs. $19.9M YoY), reflecting R&D step‑up for Phase 3 trials and the prostate study .

Financial Results

P&L and Cash Trends (oldest → newest)

Metric	Q3 2024	Q4 2024	Q1 2025
Total Operating Expenses ($M)	$30.1	$36.4	$36.1
R&D Expense ($M)	$27.6	$33.5	$32.2
G&A Expense ($M)	$2.5	$3.0	$3.9
GAAP Net Loss ($M)	$(29.8)	$(36.7)	$(37.0)
GAAP EPS (Basic & Diluted)	$(0.70)	$(0.85)	$(0.86)
Non‑GAAP Adjusted Net Loss ($M)	$(27.6)	$(32.3)	$(34.7)
Non‑GAAP EPS	$(0.65)	$(0.75)	$(0.81)
Net Cash Used in Ops ($M)	$20.6	$27.8	$35.9
Cash, Cash Equivalents & ST Investments ($M)	$264.1	$235.1	$205.7
Wtd Avg Shares (Basic & Diluted)	42,793,047	42,873,934	43,052,757

Notes and non‑GAAP adjustments for Q1 2025: add‑backs include stock‑based comp (R&D $1.5M; G&A $0.9M), non‑cash interest expense $0.8M, and non‑cash interest income $(0.9)M . YoY (Q1’25 vs Q1’24): R&D up to $32.2M from $20.6M; G&A up to $3.9M from $1.8M; GAAP EPS $(0.86) vs $(0.64); non‑GAAP EPS $(0.81) vs $(0.59) .

Versus Wall Street Consensus (S&P Global)

Metric	Q1 2025 Consensus	Q1 2025 Actual (Primary/Adjusted)	Surprise
EPS (Primary)*	$(0.862)*	$(0.81)*	+$0.05 (beat)*

Values marked with * retrieved from S&P Global.

Revenue and Segments

Celcuity is pre‑commercial with no product revenue; consensus Revenue for Q1 2025 was $0 [GetEstimates; S&P Global].

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VIKTORIA‑1 WT topline	2025	Q2 2025 topline expected	Q3 2025 topline expected	Lowered/delayed
VIKTORIA‑1 PIK3CA mutant topline	2025	2H 2025	Q4 2025	Maintained/narrowed window
VIKTORIA‑2 first patient dosed	Q2 2025	On track for Q2 2025	Anticipated Q2 2025	Maintained
CELC‑G‑201 (mCRPC) Phase 1b topline	Late Q2 2025	Late Q2 2025	Late Q2 2025	Maintained
Cash runway	Through 2026	Through 2026	Through 2026	Maintained
Endometrial cancer collaboration	2025	—	New collaboration with Dana‑Farber/MGH; company to provide drug and clinical support	New

Why the WT delay: variability in distribution of progression events across 3‑arm trial; event thresholds now near with reduced variability risk .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q‑2: Q3’24; Q‑1: Q4’24)	Current Period (Q1’25)	Trend
Data timelines	Q3’24: WT topline late Q1/Q2’25; mutant 2H’25 . Q4’24: WT topline Q2’25; mutant Q4’25; prostate late Q2’25 .	WT now Q3’25; mutant Q4’25; prostate late Q2’25 reaffirmed	WT delayed (Q2→Q3)
Regulatory strategy	RTOR/priority review contemplated post‑topline .	No change; focus remains on high‑quality topline (median PFS, HR)	Maintained
Efficacy bar and context	Emphasis on 3‑month mPFS and hazard ratio relevance; heterogeneous control arms in comps .	Reiterated mPFS + HR benchmarks; plan to disclose mPFS and HR at topline	Maintained
Safety/tolerability positioning	Favorable discontinuation profile vs single‑node PAM inhibitors; IV admin advantages .	Reiterated tolerability importance; limited incremental cost for endometrial collaboration	Maintained
Commercial potential	Peak rev opportunity cited; large eligible populations .	Reiterated ~200k global eligible; potential >$2B peak with 40% penetration if approved	Maintained
Cash/runway	$264.1M (Q3’24) to $235.1M (Q4’24); runway through 2026 .	$205.7M; runway through 2026	Cash down on spend; runway maintained

Management Commentary

“We now expect to report topline data for the PIK3CA wild-type cohort of the VIKTORIA‑1 trial in the third quarter of this year… If our topline data from the WT cohort is positive, we expect the data will support the filing of our first new drug application and, if approved, our transition to a commercial stage company.” — Brian Sullivan, CEO .
“We have an exciting year ahead of us with multiple upcoming clinical data readouts… we estimate that nearly 200,000 late-stage cancer patients globally would be eligible to be treated with gedatolisib.” — CEO prepared remarks .
“The data readout… will only include the median PFS and the hazard ratios for the two primary analyses. The subsequent data will be presented at a medical conference later in the year.” — CEO on topline scope .
On WT timing change: variability from 3‑arm design and dual primary analyses made estimates imprecise earlier; variability now “de minimis,” enabling a June data cutoff and Q3 readout .
On endometrial study economics: company providing drug and clinical support; “don’t think we’ll have any incremental financial effect” .

Q&A Highlights

Readout mechanics: Data cutoff at event threshold in June; expect database lock and topline in Q3; typical cycle “no more than 3 months and typically less” from lock to topline .
Topline content: press release to include median PFS and hazard ratios for the two primary analyses; OS details reserved for a later conference .
Competitive dynamics: SERENA‑6 seen as not impacting second‑line target population; if data are favorable, physicians may continue CDK4/6 with a regimen including gedatolisib across WT and mutant .
Efficacy bar: ~3‑month mPFS improvement and statistically significant HR viewed as clinically meaningful; no specific target HR disclosed pre‑readout .
Endometrial collaboration: study with Dana‑Farber/MGH; company supplies drug and support; minimal incremental cost .
Prostate (CELC‑G‑201): Phase 1b compares 120mg vs 180mg 3‑weeks‑on/1‑week‑off; primary analysis is 6‑month landmark PFS plus safety; dose optimization and safety drive next steps .

Estimates Context

Q1 2025 EPS (Primary, non‑GAAP) beat: consensus $(0.862)* vs actual $(0.81), a +$0.05 surprise. Revenue consensus was $0* as the company is pre‑commercial. Values retrieved from S&P Global.
Implication: modest EPS beat driven by S&P’s “Primary” (adjusted) framing; GAAP loss per share was $(0.86), reflecting higher R&D spend .

Key Takeaways for Investors

The key catalyst is the VIKTORIA‑1 PIK3CA WT topline in Q3 2025; management intends to disclose median PFS and hazard ratios at topline—these two parameters will likely drive stock reaction on readout .
The WT readout timing slip (Q2→Q3) appears operational (event timing) rather than strategic; mutant cohort timing remains Q4 2025, preserving a stacked 2H’25 catalyst path .
Cash runway through 2026 provides sufficient funding to reach (and digest) both VIKTORIA‑1 toplines and begin VIKTORIA‑2 enrollment, but quarterly cash burn increased to ~$36M in Q1 and should be monitored .
Non‑GAAP EPS beat versus consensus is not a fundamental driver at this stage; value inflection is tied to VIKTORIA‑1 efficacy (mPFS and HR), tolerability, and commercial positioning in second‑line HR+/HER2‑ mBC .
Management continues to signal commercial readiness if data are positive (RTOR/priority review contemplated), with strategic rationale for IV administration and broad WT/mutant coverage potentially differentiating vs single‑node PAM inhibitors .
Additional catalyst: CELC‑G‑201 Phase 1b topline by late Q2 2025; while earlier stage, favorable safety/landmark PFS could broaden the gedatolisib thesis beyond breast cancer .
Watch for any pre‑readout quiet period and for conference selection for the full WT data package later in 2025 .

Appendix: Additional Q1 2025 Financial Detail (YoY)

R&D up ~$11.6M YoY to $32.2M, driven by employee/consulting (+$5.9M) and clinical trial activity (+$5.7M) .
G&A up ~$2.1M YoY to $3.9M, led by personnel/consulting (+$1.6M) and other administrative costs (+$0.5M) .
Non‑GAAP reconciling items included stock‑based comp (R&D $1.505M; G&A $0.939M), non‑cash interest expense $0.800M, and non‑cash interest income $(0.946)M .

Celcuity Inc. (CELC)·Q1 2025 Earnings Summary