Celcuity (CELC) Q1 2026 earnings summary

Executive summary

• Achieved significant milestones for gedatolisib, including positive Phase 3 VIKTORIA-1 results in HR+/HER2- advanced breast cancer and expansion of VIKTORIA-2 to first-line endocrine-sensitive patients, with ongoing studies in prostate and endometrial cancers.

• NDA for gedatolisib accepted by FDA with Priority Review and PDUFA date set for July 17, 2026; commercial launch preparations underway.

• Full commercial organization built, including experienced oncology sales specialists.

• No revenue generated to date; focus remains on R&D and commercialization pending FDA approval.

• Submitted first patent application for subcutaneous gedatolisib formulation.

Financial highlights

• Q1 2026 net loss was $52.8 million ($0.97/share), up from $37.0 million ($0.86/share) in Q1 2025, driven by increased R&D and SG&A expenses.

• Non-GAAP adjusted net loss was $46.8 million ($0.86/share) vs. $34.7 million ($0.81/share) year-over-year.

• R&D expenses rose to $33.1 million, SG&A expenses to $17.4 million, and total operating expenses to $50.5 million.

• Cash, cash equivalents, and short-term investments totaled $387.1 million at quarter-end.

• Net cash used in operating activities was $55.1 million, up from $35.9 million year-over-year.

Outlook and guidance

• Sufficient liquidity to fund operations through 2027, assuming current business plan and available borrowings.

• Anticipates FDA decision by July 17, 2026, with commercial launch readiness ahead of PDUFA date.

• Expects potential revenue from gedatolisib sales in the second half of 2026, pending FDA approval.

• Top-line data for VIKTORIA-2 Study 1 expected by end of 2028; Study 2 data expected by 2030.

• Plans to submit supplemental NDA and regulatory filings outside the U.S. following ASCO data presentation.