Celcuity (CELC) investor relations material

Executive summary

• Achieved FDA approval for REVTORPYK (gedatolisib) for HR-positive/HER2-negative advanced breast cancer without PIK3CA mutation, with commercial launch set for late Q3 2026 and shipments expected to begin then.

• VIKTORIA-1 Phase 3 trial showed significant efficacy and safety in both PIK3CA wild-type and mutant cohorts, with PFS improvement over alpelisib plus fulvestrant; sNDA submission for mutant cohort planned for Q3 2026.

• NCCN updated guidelines to include REVTORPYK as a preferred Category 1 second-line or later therapy for HR+/HER2- breast cancer without PIK3CA mutation.

• Expanded VIKTORIA-2 trial to include first-line, endocrine-sensitive patients, broadening clinical development; ongoing trials in prostate cancer and other indications.

• Commercial launch infrastructure completed, with 88 oncology sales specialists and payer engagement underway; Expanded Access Program initiated ahead of launch.

Financial highlights

• Q2 2026 net loss was $78.9M ($1.44/share), up from $45.3M ($1.04/share) year-over-year; non-GAAP adjusted net loss was $58.7M ($1.07/share).

• Operating expenses for Q2 2026 were $66.1M, a 50% increase from Q2 2025, mainly due to a 361% rise in SG&A for launch activities.

• R&D expenses decreased to $31.1M from $36.4M, while SG&A expenses rose to $35M from $7.6M.

• Cash, equivalents, and short-term investments totaled $754M as of June 30, 2026, boosted by a $575M convertible note offering.

• No revenue generated as of June 30, 2026; first product sales expected in Q3 2026.

Outlook and guidance

• sNDA submission for PIK3CA mutant cohort planned for Q3 2026; further VIKTORIA-1 updates and prostate cancer data expected later in 2026.

• Cash runway expected to finance operations into 2029.

• Revenue from REVTORPYK sales anticipated to begin in Q3 2026; expenses expected to rise as commercialization ramps up.