other material
confidence high
sentiment positive
materiality 0.80
Celcuity expands debt to $75M, Q2 net loss $10M, gedatolisib gets Breakthrough Therapy
Celcuity Inc.
- Debt facility amended to up to $75M ($50M increase); $15M drawn, $20M due on private placement close; other tranches tied to clinical milestones.
- Q2 2022 net loss $10.0M ($0.67 loss per share) vs $14.0M ($1.11) in Q2 2021; non-GAAP adjusted loss $8.3M ($0.55).
- FDA granted Breakthrough Therapy designation in July for gedatolisib in HR+/HER2- metastatic breast cancer.
- Private placement of $100M equity signed May 2022; closing expected after first patient dosed in VIKTORIA-1.
- VIKTORIA-1 Phase 3 trial on track to dose first patient shortly; FACT-1/2 interim data expected mid-2023.