New York, May 19, 2026, 19:04 EDT
- SELLAS Life Sciences closed at $7.59, up about 4.1%, while the SPDR S&P Biotech ETF fell and the iShares Nasdaq Biotechnology ETF edged higher.
- CEO Angelos Stergiou told a Stifel oncology forum that REGAL, the company’s late-stage AML trial, is nearing the 80-event trigger for final analysis.
- SELLAS reported $107.1 million in cash at March 31 and a first-quarter net loss of $8.4 million.
SELLAS Life Sciences Group shares rose on Tuesday after the cancer-drug developer’s chief executive told investors its closely watched late-stage acute myeloid leukemia trial was near the point that will allow final data analysis.
The stock closed at $7.59, up 4.1%, and traded between $6.85 and $8.35. The move stood out in a mixed biotech tape: the SPDR S&P Biotech ETF slipped about 0.7%, while the iShares Nasdaq Biotechnology ETF gained about 0.1%.
The issue now is timing. SELLAS said last week that 78 of the 80 required “events,” or deaths in the study, had occurred in REGAL, its Phase 3 trial of galinpepimut-S, or GPS, in acute myeloid leukemia, a blood cancer often shortened to AML. Overall survival — how long patients live after treatment — is the trial’s main yardstick. Sellas Life Sciences
At the Stifel 2026 Targeted Oncology Virtual Forum on Tuesday, Stergiou said SELLAS was “expecting data very soon.” Stifel senior biotech analyst Stephen Willey framed the question more bluntly, saying the company was “just a couple of events” from triggering the overall survival analysis. StockAnalysis
Stergiou said the company remains blinded to the trial outcomes, meaning it does not yet know which patients received which treatment or how the arms performed. Once the 80th event occurs, he said data cleaning and related steps could take “a few weeks,” with more guidance to come at that point. StockAnalysis
REGAL compares GPS with best available treatment in patients with AML who are in second complete remission. The trial is event-driven, which means the final analysis is triggered by a preset number of outcomes rather than a calendar date. SELLAS said in its quarterly filing that the final analysis could occur at a different time than expected and that it will announce the 80th event when it occurs.
The run-up has been sharp. SELLAS shares closed at $5.22 on May 12, the day the company reported first-quarter results, and at $7.59 on Tuesday. The company’s market value was about $1.31 billion.
The competitive context is narrow but important. Bristol Myers Squibb’s ONUREG is approved as continued treatment for certain AML patients in first remission, while venetoclax-based regimens, including AbbVie and Genentech’s VENCLEXTA with azacitidine, are used in newly diagnosed AML patients who are older or not fit for intensive chemotherapy. Stergiou referred to both treatment areas while laying out how GPS and SLS009 could fit across AML care.
SELLAS is also developing SLS009, or tambiciclib, a CDK9 inhibitor — a drug designed to block a protein involved in cancer-cell survival. Stergiou said top-line data from a Phase 2 SLS009 study are expected later this year, while earlier preclinical work showed effects on AML cell survival pathways. Dr. Philip Amrein of Mass General Brigham Cancer Institute said those data pointed to “clinically actionable schedules” for the drug. StockAnalysis
The balance sheet gives the company some room. SELLAS reported $107.1 million in cash and cash equivalents at March 31, after receiving $44.1 million from warrant exercises in the first quarter, and another $7.5 million after quarter-end. It also has an at-the-market program, or ATM — a facility to sell new shares over time — for up to $150 million, though it said no shares had been sold through it as of the filing.
But this remains a binary biotech setup. A positive REGAL result could support a filing for approval, but a miss on survival would likely reset expectations quickly. SELLAS also told investors it has no product-sale revenue, has recurring losses, and may need additional financing; that could dilute shareholders if new stock is sold.
The next near-term investor stop is A.G.P.’s Annual Virtual Healthcare Conference on Wednesday, followed by TD Cowen’s oncology summit on May 27. The company has not said those events will include trial results.
