TLDR
- SELLAS stock rose 20% in extended trading Thursday as REGAL trial results neared.
- The Phase 3 trial reached its 80th event, which triggered the final analysis.
- Q3 net loss was $10.1 million, or $0.05 per share, matching estimates.
- Cash stood at $134.7 million on September 30, up from $71.8 million at the end of 2025.
- A second leukemia program has preliminary data due this quarter.
SELLAS Life Sciences (SLS) stock jumped 20% in extended trading Thursday. The move followed word that leukemia trial results are close.
SELLAS Life Sciences Group, Inc., SLS
The stock had closed the regular session down 4.63%. Even so, it has more than doubled so far this year.
The clock is now the story. SELLAS said its Phase 3 REGAL trial reached its 80th event in October, the trigger for the final analysis.
The trial tests galinpepimut-S, or GPS, in acute myeloid leukemia patients in second complete remission. Its main goal is overall survival.
Next come database lock, unblinding and statistical analysis. Topline results are expected in November, inside the fourth quarter.
Chief Executive Angelos Stergiou said the company continues to execute across both clinical programs as milestones near. He did not give a firmer date.
The Quarter in Numbers
SELLAS posted a third quarter net loss of $10.1 million, or $0.05 per share. A year earlier, the loss was $6.8 million, or $0.06 per share.
The per-share loss shrank even as the total loss grew. The weighted-average share count rose to about 202.4 million from 108.4 million.
The company reported no revenue, matching the consensus estimate of $0.00. The per-share loss also matched Wall Street’s forecast.
Research and development spending rose to $7.0 million from $4.2 million. The company pointed to manufacturing, consulting and trial costs tied to a possible GPS regulatory filing.
General and administrative costs reached $4.3 million, up from $2.9 million. Loss from operations was $11.3 million for the quarter and $31.2 million for nine months.
Cash and equivalents totaled $134.7 million on September 30. That compares with $71.8 million at the end of 2025.
A Second Leukemia Program Waits in the Wings
SLS009, also called tambiciclib, is in a Phase 2 trial for newly diagnosed AML. Forty of 80 planned patients are enrolled, with preliminary data due in the fourth quarter.
Completed Phase 2 data in relapsed or refractory AML showed response rates of 54% in monocytic disease and 57% in TP53-mutated disease. Median overall survival was 5.8 months and 8.8 months.
SELLAS said those results compare favorably with historical outcomes of about 2.5 months. It added that historical comparisons do not prove superiority in a randomized trial.
The company will present those findings at the American Society of Hematology meeting in December. Preclinical pancreatic cancer work also supports further study of SLS009 with RAS-directed therapy.
