New York, May 12, 2026, 18:01 EDT
- SELLAS reported that its pivotal REGAL trial in leukemia has now logged 78 out of the required 80 events for final analysis.
- The company reported a larger net loss for the first quarter, though cash at the end of March stood at $107.1 million.
- After the bell, shares climbed, with investors zeroed in on the looming trial readout.
Shares of SELLAS Life Sciences climbed in after-hours action Tuesday, following the company’s update that its Phase 3 REGAL trial in acute myeloid leukemia has now logged 78 out of the 80 patient deaths required for the final analysis. In this pivotal study, patient death is the event that triggers the survival analysis.
The 80th event triggers what’s known as database lock—a last sweep through the data ahead of analysis. From there: blinded review, stats work, unblinding, and then SELLAS reports the topline readout, that first main batch of results. The company says it still hasn’t seen any trial outcomes.
Cash is lifeblood for a biotech without product sales. SELLAS reported $107.1 million in cash and cash equivalents on March 31, and it’s added another $7.5 million from warrant exercises since quarter-end. Management figures that should cover planned operations for no less than 12 months.
Chief Executive Angelos Stergiou described the quarter as an “important period” for the company, pointing to the upcoming REGAL result as an “important milestone.” The study is evaluating galinpepimut-S, also known as GPS, in people with acute myeloid leukemia—a rapidly progressing cancer of the blood and bone marrow—who’ve reached remission after second-line salvage therapy. SEC
SELLAS posted a net loss of $8.4 million for the first quarter, translating to a loss of 5 cents per share. That compares with a $5.8 million loss, or 7 cents a share, in the same period last year. The reduction in per-share loss reflects a sharp increase in the weighted average share count, which almost doubled to 172.5 million.
SELLAS bumped up its research and development outlays to $5.1 million, up from $3.2 million. The company pointed to heavier manufacturing, clinical, and regulatory expenses as it gets ready for a potential biologics license application—the official U.S. green light request for a biologic drug—if REGAL delivers the necessary backing.
SELLAS is administering SLS009—tambiciclib—in an 80-patient Phase 2 trial targeting newly diagnosed first-line AML. This mid-stage study aims to assess safety and early efficacy signals. Topline results are slated for the fourth quarter of 2026, according to the company.
That program positions SELLAS close to the AZA/VEN segment—that’s azacitidine plus venetoclax. Venetoclax, marketed as Venclexta, comes from AbbVie and Roche. The drug is cleared for use with azacitidine, decitabine, or low-dose cytarabine in select newly diagnosed AML adults who are older or not eligible for intensive chemo.
Reaction came fast. After hours, MarketScreener posted SELLAS at $6.095 by 6:00 p.m. EDT—a jump of 16.76%. Earlier, the stock wrapped up regular Nasdaq trading down 0.57%, settling at $5.22.
Still, the outcome boils down to a binary risk. In its latest quarterly filing, SELLAS flagged uncertainty in its financing outlook, and noted that additional fundraising could dilute current shareholders. If needed capital doesn’t materialize in time, research programs might be delayed, scaled back, or even scrapped.
Another issue hangs in the balance: SELLAS remains locked in arbitration with 3D Medicines over GPS milestone payments and development duties in Greater China. The two sides met in Hong Kong for a hearing back in January. Now, they’re waiting on a final decision.
Right now, it’s a waiting game for REGAL’s 80th event. The immediate focus: does the data review check out, and will the survival readout hand SELLAS the leverage it needs to make a regulatory push for GPS? Until SELLAS unmasks the study, traders are positioning on the expectation, not the outcome.
