Celcuity (CELC) Q3 2024 earnings summary

Executive summary

• Achieved full enrollment in the VIKTORIA-1 Phase III PIK3CA wild-type cohort; mutant cohort enrollment remains on track, with topline data expected late Q1 or Q2 2025 and mutant cohort data in H2 2025.

• VIKTORIA-2 Phase III trial is set to enroll its first patient in Q2 2025, expanding the clinical program to up to 200 global sites.

• Preliminary data from the phase Ib/II prostate cancer (mCRPC) trial expected in Q2 2025.

• No revenue generated to date; operations funded by equity and debt offerings, with significant R&D investment and ongoing clinical trials.

• Encouraging feedback from oncologists and market access stakeholders regarding gedatolisib's IV administration and potential market positioning.

Financial highlights

• Q3 2024 net loss was $29.8 million ($0.70 per share), compared to $18.4 million ($0.83 per share) in Q3 2023; non-GAAP adjusted net loss was $27.6 million ($0.65 per share) versus $17.3 million ($0.78 per share) in Q3 2023.

• Research and development expenses rose to $27.6 million in Q3 2024, up 58% year-over-year, mainly due to clinical trial activities and increased personnel costs.

• General and administrative expenses increased to $2.5 million in Q3 2024, up 75% year-over-year.

• Ended Q3 2024 with $264.1 million in cash, cash equivalents, and short-term investments, up from $180.6 million at year-end 2023, driven by $138.3 million in net financing proceeds.

• Interest expense for Q3 was $3.3 million, up 144% year-over-year, reflecting new debt financing; interest income for Q3 was $3.6 million, up $1.7 million year-over-year.

Outlook and guidance

• Sufficient cash, investments, and available borrowings expected to fund operations through 2026 based on current business plan.

• NDA filing planned if wild-type cohort results are positive, with a supplemental NDA to follow for the mutant cohort.

• Peak revenue potential for gedatolisib in the second-line indication estimated to exceed $2 billion if approved for both populations.