earnings
confidence high
sentiment neutral
materiality 0.70
Galera reports Q3 net loss $16M; avasopasem NDA on track by year-end
Galera Therapeutics, Inc.
2022-Q3 EPS reported
-$1.72
- Net loss of $16M ($0.60/share) vs $22.6M ($0.86) in Q3 2021; cash $42.8M.
- NDA for avasopasem in radiotherapy-induced severe oral mucositis remains on track for submission by end of 2022.
- One-year ROMAN follow-up showed tumor outcomes and overall survival maintained; 50% reduction in chronic kidney disease (10% vs 20% placebo, p=0.0043).
- Meta-analysis of ROMAN and GT-201 (n=551) showed reductions in SOM incidence, duration, onset, and severity.
- Appointed Eugene P. Kennedy, M.D., as Chief Medical Officer, succeeding Jon T. Holmlund who plans to retire.