TLDR
- SELLAS stock rose 20% in after-hours trading Thursday after a regular session decline of 4.63%.
- The Phase 3 REGAL trial hit its 80th event, which set the final analysis in motion.
- The Q3 loss was $10.1 million, or $0.05 per share, in line with estimates.
- Cash climbed to $134.7 million from $71.8 million at the end of 2025.
- Early data from the SLS009 leukemia trial is due in the fourth quarter.
SELLAS Life Sciences (SLS) stock rallied 20% in after-hours trading Thursday. The jump came as the company said its pivotal leukemia trial data is close.
SELLAS Life Sciences Group, Inc., SLS
The stock had slipped 4.63% in the regular session. It is still up more than 100% so far in 2026.
The Phase 3 REGAL trial reached its 80th event in October. Now the waiting game begins.
REGAL tests galinpepimut-S, known as GPS, in acute myeloid leukemia patients in second complete remission. The main goal is overall survival.
Next up are database lock, unblinding and statistical analysis. Topline results are due in the fourth quarter, and the company had targeted November.
CEO Angelos Stergiou said the company continues to execute across both clinical programs. He added that important milestones are getting closer.
Why the Loss Per Share Got Smaller
SELLAS lost $10.1 million in the third quarter, or $0.05 per share. A year ago, the loss was $6.8 million, or $0.06 per share.
The total loss grew, yet the per-share figure fell. The average share count jumped to about 202.4 million from 108.4 million.
That per-share loss matched Wall Street’s forecast. Revenue was zero, also in line with estimates.
Research and development costs rose to $7.0 million from $4.2 million. Higher manufacturing, consulting and trial costs drove the increase as the company prepares for a possible GPS filing.
General and administrative costs rose to $4.3 million from $2.9 million. Operating loss was $11.3 million for the quarter and $31.2 million for nine months.
Cash and equivalents stood at $134.7 million on September 30. That is up from $71.8 million at the end of 2025.
SLS009 and the December Calendar
SELLAS is also testing SLS009, called tambiciclib, in newly diagnosed AML. Forty of 80 planned patients are enrolled in that Phase 2 study.
Earlier Phase 2 work 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.
The company said that compares with historical outcomes of about 2.5 months. It noted that such comparisons do not prove superiority in a randomized trial.
Preclinical work in pancreatic cancer models also supports more study of SLS009 alongside RAS-directed therapy. Early data from the newly diagnosed AML trial is due in the fourth quarter.
The company will present the completed Phase 2 findings at the American Society of Hematology meeting in December.
