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Jun 30, 2024
Celcuity Q2 2024 Earnings Report
Celcuity reported financial results for the second quarter of 2024 and provided a corporate update.
Key Takeaways
Celcuity's operating expenses increased to $24.3 million, driven by higher R&D spending related to the VIKTORIA-1 and CELC-G-201 clinical trials. The net loss was $23.7 million, or $0.62 per share, compared to a net loss of $14.6 million, or $0.66 per share, for the second quarter of 2023. Cash, cash equivalents and short-term investments totaled $283.1 million at the end of the quarter.
Advanced clinical development of gedatolisib with robust enrollment in VIKTORIA-1.
Initiated efforts to launch VIKTORIA-2, a Phase 3 study for HR+, HER2- advanced breast cancer.
Expects topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025.
Total operating expenses were $24.3 million, including $22.5 million in R&D expenses.
Forward Guidance
Celcuity is focused on advancing the clinical development of gedatolisib and initiating new clinical trials.
Positive Outlook
- Enrollment in VIKTORIA-1 remains robust and on-track.
- Initiated efforts to launch VIKTORIA-2.
- VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer.
- CELC-G-201 is evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer.
- VIKTORIA-2 is evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer.
Challenges Ahead
- Proportion of patients with PIK3CA wild-type tumors has recently shifted lower than original estimates.
- Expect to reach the enrollment target for the PIK3CA wild-type cohort in the fourth quarter, rather than the third quarter.
- Expect topline data for the PIK3CA WT cohort to shift to sometime between late Q4 2024 and Q1 2025.
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