Key Takeaways
- Sellas shares fell 18% today after the company said its Phase 3 REGAL trial in acute myeloid leukemia reached the 80th death, which triggers the trial’s final analysis.
- The drop looks like investors selling the news after a 223% run this year, because the overall-survival result is still to come.
- The trial took about 10 months longer than Sellas planned to reach 80 deaths, and Sellas had $138 million of cash and short-term investments at June 30.
- Topline results are due this quarter, and a win could lead to a filing with the FDA.
Sellas Life Sciences (SLS) stock sank 18% today after the company said its pivotal Phase 3 REGAL trial in acute myeloid leukemia (AML) had reached the 80th death, which triggers the trial’s final analysis.
CEO Angelos Stergiou called it “a critical milestone in the REGAL trial.” Investors had a 223% gain in the stock this year through Tuesday’s close, and they took the chance to sell.
The answer is still to come
REGAL tests galinpepimut-S (GPS) as maintenance therapy for AML patients in their second complete remission, against the investigator’s choice of best available therapy. Overall survival is the primary endpoint, so the 80th death starts the clock. Sellas now moves to database lock, unblinding and the statistical analysis, with topline results due this quarter.
Sellas still doesn’t know whether GPS works, because it remains blinded to the survival data. In August, Stergiou said a successful trial could lead to a BLA submission to the FDA.
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Eighty took a while
Getting here took far longer than planned. In December 2025, Sellas said it had expected the 80th event before year-end, but the count stood at 72 as of Dec. 26. It reached 78 by May 11, and the last two deaths took until late October.
The count covers both arms, so this is pure speculation, but the hopeful reading is that patients on GPS are living longer. The other possibility (and l ikely the market’s fear) is that patients on standard therapy are also doing better than the trial’s design assumed, which would leave GPS a smaller gap to prove.
What’s next
Sellas had $138 million of cash and short-term investments at June 30, nearly double the $71.8 million it held at the end of 2025…
…and it burns cash every quarter while it waits on REGAL.
Of course, a win means paying for a BLA filing and a launch, so a stock sale after good data wouldn’t be a surprise.
Analysts have raised their sights all year, taking the consensus price target from $6.83 to $32.50:
Today’s release carries no efficacy data, so it gives them no reason to change those targets either way.
My take: today’s drop is investors cashing in ahead of a yes-or-no result. The topline overall-survival data due this quarter is the real test for Sellas, and the stock could move far more on it, in either direction.
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Disclaimer:
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