SELLAS Life Sciences Group saw its stock rise 4.1% to close at $7.59 on Tuesday, following a key update from CEO Angelos Stergiou at a Stifel oncology forum. The company's late-stage REGAL trial for acute myeloid leukemia (AML) is now just two events away from triggering the final overall survival analysis, a milestone that could determine the drug's path to regulatory approval.
Stergiou revealed that 78 of the required 80 events, defined as deaths in the study, have occurred in the Phase 3 trial of galinpimut-S (GPS). The trial remains blinded, meaning SELLAS does not yet know which patients received GPS versus best available treatment. Once the 80th event is reached, data cleaning and analysis are expected to take a few weeks, with more guidance to follow.
The stock's performance stood out against a mixed biotech backdrop. The SPDR S&P Biotech ETF slipped about 0.7%, while the iShares Nasdaq Biotechnology ETF edged up roughly 0.1%. SELLAS shares traded between $6.85 and $8.35 during the session, reflecting heightened investor attention on this binary event.
Financial Position and Cash Runway
SELLAS reported $107.1 million in cash and cash equivalents as of March 31, following $44.1 million from warrant exercises in the first quarter and an additional $7.5 million after quarter-end. The company also has an at-the-market (ATM) facility for up to $150 million, though no shares had been sold through it as of the latest filing.
Despite the cash position, the company has no product-sale revenue and posted a first-quarter net loss of $8.4 million. Management has acknowledged that additional financing may be needed, which could dilute existing shareholders if new stock is issued.
Competitive Landscape and Pipeline
The AML treatment landscape includes Bristol Myers Squibb's ONUREG for patients in first remission and AbbVie and Genentech's VENCLEXTA (venetoclax) with azacitidine for older or unfit newly diagnosed patients. Stergiou positioned GPS and the company's second candidate, SLS009 (tambiciclib), a CDK9 inhibitor, as potential options across the AML care continuum.
Top-line data from a Phase 2 study of SLS009 are expected later this year. Dr. Philip Amrein of Mass General Brigham Cancer Institute noted that earlier preclinical work pointed to clinically actionable dosing schedules for the drug.
Market Implications and Risks
The REGAL trial is event-driven, meaning the final analysis is triggered by a preset number of outcomes rather than a fixed calendar date. A positive result could support a filing for approval, but a miss on survival would likely reset expectations quickly. The binary nature of the setup has driven a sharp run-up: SELLAS shares closed at $5.22 on May 12, the day first-quarter results were reported, and have since gained about 45%.
Investors will be watching upcoming events, including A.G.P.'s Annual Virtual Healthcare Conference on Wednesday and TD Cowen's oncology summit on May 27. The company has not indicated whether trial results will be disclosed at those events.
