Celcuity (CELC) Q2 2026 earnings summary

Executive summary

• Achieved FDA approval for REVTORPYK (gedatolisib) for HR-positive/HER2-negative advanced breast cancer without PIK3CA mutation on July 14, 2026, with commercial launch and shipments expected late Q3 2026.

• VIKTORIA-1 Phase 3 trial showed significant efficacy and safety in both PIK3CA wild-type and mutant cohorts, with PFS improvements over standard therapies; sNDA for mutant cohort planned for Q3 2026.

• Expanded VIKTORIA-2 trial to include first-line, endocrine-sensitive HR+/HER2- patients, broadening potential indications.

• Commercial infrastructure and launch activities are fully operational, with a wholesale acquisition cost set at $30,000 per cycle and no revenue generated as of June 30, 2026.

• Estimated total addressable U.S. market for REVTORPYK exceeds $6 billion annually, with NCCN guideline inclusion expected to drive adoption.

Financial highlights

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

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

• R&D expenses decreased to $31.1 million, while SG&A expenses rose to $35 million, driven by commercial headcount and launch preparations.

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

• Interest expense rose to $5.4 million in Q2 2026 due to new convertible notes.

Outlook and guidance

• sNDA submission for the PIK3CA mutant cohort planned for Q3 2026, with global regulatory filings to follow.

• Shipments of REVTORPYK expected to begin late Q3 2026; Expanded Access Program opened ahead of commercial launch.

• Current cash position expected to finance operations at least into 2029.

• Further clinical data updates for prostate cancer and VIKTORIA-1 cohorts anticipated later in 2026.