Celcuity (CELC) Q2 2026 Earnings Report

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Previous Report: Q1 2026

CELC Q2 2026 EPS Results

Actual EPS-$1.44

Consensus EPS-$1.17

Beat/MissMissed by -$0.27

One Year Ago EPS-$1.04

CELC Q2 2026 Revenue Results

Actual Revenue$0.00

Expected Revenue$0.00

Beat/MissMet expectations

YoY Revenue Growth―

Earnings Announcement Details

QuarterQ2 2026

Date08/13/2026

TimeAfter Close

Conference CallThursday, August 13, 2026

CELC Upcoming Earnings

Celcuity's next earnings date is estimated for November 18, 2026, based on past reporting schedules.

Q2 2026 Earnings Call Audio

CELC Q2 2026 Earnings Call

0:00 / 0:00

Q2 2026 Earnings Slide Deck

No slide deck is available for this earnings event.

Q2 2026 Earnings Call Summary

Q2 2026

Earnings Call Date:Aug 13, 2026|

% Change Since:

Earnings Call Sentiment|Positive

The call conveyed strong positive momentum: regulatory approval (FDA), rapid NCCN Category 1 endorsement, robust phase 3 efficacy (large PFS gains and lower discontinuation vs comparator), commercial launch readiness, a sizeable addressable market (> $6B annual TAM) and a fortified balance sheet with a cash runway into 2029. Offsetting risks include materially higher operating losses and SG&A tied to launch investments, increased near-term cash burn, conditional reliance on FDA review for a secondary manufacturing site (supply risk), and limited real-time utilization visibility for an IV therapy. Overall, the operational and clinical wins materially outweigh the financial and execution risks described.

Company Guidance

Management guided that Revtopik (gedatolisib) shipments are expected to begin late Q3 2026 and an sNDA for the PIK3CA‑mutant VICTORIA‑1 cohort will be submitted in Q3 2026 with global filings to follow; WAC is $10,000 per vial ($30,000 per cycle), Celcuity estimates ~37,000 U.S. second‑line HR+/HER2‑ patients, ~10 cycles/patient and >$6 billion annual TAM at WAC with an expected gross‑to‑net of ~80% (≈20% discounts). Key clinical metrics: in the PIK3CA‑mutant cohort median PFS was 11.1 months (gedatolisib triplet) vs 5.6 months (alpelisib+fulvestrant; HR 0.50) and 11.3 months (gedatolisib doublet) vs 5.6 months (HR 0.51); discontinuation rates due to AEs were ~5.2% (triplet) and 3.8% (doublet) vs 19% for alpelisib; mean gedatolisib cycles were 9.0 (wild‑type triplet; 12% still on), 10.0 (mutant triplet; 22% still on), 9.7 (wild‑type doublet; 12% still on) and 11.3 (mutant doublet; 19% still on). Financials and operational notes: Q2 net loss $78.9M ($1.44/share), non‑GAAP loss $58.7M ($1.07/share), R&D $31.1M, SG&A $35.0M, net cash used in operations $55.4M; cash and short‑term investments $754M at 6/30/2026 (proceeds from $575M convertible offering, net $557.2M; $137M term‑loan repayment) with runway into 2029; expanded access shipments have begun, the secondary manufacturing site requires FDA clearance (review often ~2–4 months; standard 4‑month cadence), and an sNDA review would be 6 months if granted priority or 10 months standard.

FDA Approval and NCCN Category 1 Recommendation

Revtopik (gedatolisib) received FDA approval (July 14, 2026) for HR+ HER2- locally advanced/metastatic breast cancer without a PIK3CA mutation after progression on ≥1 line of endocrine therapy. NCCN updated guidelines to recommend both the gedatolisib triplet and doublet as preferred Category 1 regimens for second-line or subsequent treatment (tumors without PIK3CA mutation).

Strong Phase 3 Efficacy in PIK3CA Mutant Cohort (VICTORIA-1)

Gedatolisib triplet median PFS = 11.1 months vs alpelisib + fulvestrant 5.6 months (HR = 0.50). Gedatolisib doublet median PFS = 11.3 months vs 5.6 months (HR = 0.51). Both comparisons were statistically significant and clinically meaningful.

Lower Treatment Discontinuation vs Comparator

Discontinuation due to adverse events: gedatolisib triplet 5.2% and doublet 3.8% vs alpelisib 19% — representing ~73% lower discontinuation for the triplet and ~80% lower for the doublet versus alpelisib in the reported analyses.

Durable Treatment Exposure in VICTORIA-1

Mean gedatolisib treatment cycles (as of Aug 2, 2026): triplet wild type 9.0 (12% still on drug), triplet mutant 10.0 (22% still on drug); doublet wild type 9.7 (12% still), doublet mutant 11.3 (19% still). These longer mean cycles support higher real-world drug usage than median-duration metrics alone.

Commercial Launch Readiness and Market Opportunity

Commercial infrastructure built: 80 oncology sales specialists (avg. 24 years' experience), payer dossiers submitted, EHR order set support, and expanded access program already shipping. WAC set at $10,000 per vial / $30,000 per cycle. Estimated US second-line patient population ~37,000 and, assuming ~10 cycles, a total addressable market >$6 billion annually.

Progress in Additional Clinical Programs and Formulation Work

VICTORIA-2 expanded to first-line endocrine sensitive study (triplet with palbociclib + letrozole). Phase 1b data in endocrine-sensitive first-line showed median PFS 48.6 months and ORR 79% (historical comparators ~25 months PFS and 53% ORR). Subcutaneous formulation development ongoing to support longer-duration use. Prostate program dose-finding completed at 240 mg with no DLTs and 300 mg evaluation underway; updated data expected in Q4 2026.

Strong Balance Sheet and Cash Runway

Cash, cash equivalents and short-term investments of $754.0M as of 06/30/2026 vs $441.5M as of 12/31/2025 (increase of $312.5M, ~70.8%). Convertible note offering generated gross proceeds of $575M and net proceeds of $557.2M. Company expects cash to fund operations at least into 2029.

Favorable Gross-to-Net Expectation

Company expects an approximate gross-to-net capture of ~80% (i.e., ~20% discounts from WAC), which management believes is better than typical oral therapies in the category.

CELC Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change
Nov 18, 2026	2026 (Q3)	-1.43 / -	-0.92	―
Aug 13, 2026	2026 (Q2)	-1.17 / -1.44	-1.04	-38.46% (-0.40)
May 14, 2026	2026 (Q1)	-1.05 / -0.97	-0.86	-12.79% (-0.11)
Mar 25, 2026	2025 (Q4)	-1.04 / -0.97	-0.85	-14.12% (-0.12)
Nov 12, 2025	2025 (Q3)	-1.02 / -0.92	-0.7	-31.43% (-0.22)
Aug 14, 2025	2025 (Q2)	-0.88 / -1.04	-0.62	-67.74% (-0.42)
May 14, 2025	2025 (Q1)	- / -0.86	-0.64	-34.37% (-0.22)
Mar 31, 2025	2024 (Q4)	-0.86 / -0.86	-0.64	-34.37% (-0.22)
Nov 14, 2024	2024 (Q3)	-0.65 / -0.70	-0.83	15.66% (+0.13)
Aug 14, 2024	2024 (Q2)	-0.68 / -0.62	-0.66	6.06% (+0.04)

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat

Missed