SELLAS Life Sciences Nears Pivotal Trial Readout As Leukemia Pipeline Progresses

SELLAS Life Sciences Group Inc. (NASDAQ:SLS) reported first-quarter (Q1) 2026 fiscal results connected Tuesday portion highlighting advancement crossed its acute myeloid leukemia (AML) pipeline.

CEO Angelos Stergiou said the institution continued advancing its objective programs during the 4th portion preparing for the anticipated information readout from its pivotal Phase 3 REGAL study.

SELLAS volition merchandise the upcoming information aft the survey reaches its pre-specified 80th lawsuit threshold — a large milestone for the company.

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REGAL Trial Approaches Final Event Threshold

SELLAS said the ongoing Phase 3 REGAL proceedings is evaluating GPS successful AML patients who achieved implicit remission pursuing second-line salvage therapy.

As of May 11, the survey had recorded 78 events. Reaching 80 events volition initiate database fastener procedures, blinded information review, statistical analysis, and eventual topline disclosure.

The institution said it plans to supply different update erstwhile the last lawsuit threshold has been reached.

SLS009 Expands Into Earlier-Line AML Treatment

SELLAS besides highlighted advancement with SLS009, including the motorboat of an 80-patient Phase 2 survey successful recently diagnosed AML patients considered improbable to payment from modular therapies specified arsenic AZA/VEN treatment.

Topline information from the survey are expected successful the 4th fourth of 2026.

The institution additionally pointed to preclinical findings presented astatine the 2026 American Association for Cancer Research meeting, showing that SLS009 promoted apoptosis successful AML compartment lines, including high-risk TP53 and ASXL1-mutant subtypes.

According to SELLAS, the information besides showed reductions successful MCL-1 and surviving levels pursuing treatment.

SELLAS Reports Higher Expenses And Wider Loss

R&D expenses roseate to $5.1 cardinal successful the archetypal 4th from $3.2 cardinal a twelvemonth earlier, chiefly owed to manufacturing, regulatory consulting, and objective proceedings costs tied to imaginable mentation for a Biologics License Application for GPS.

General and administrative expenses accrued to $4.1 cardinal from $2.9 cardinal successful the prior-year quarter.

SELLAS reported a nett nonaccomplishment of $8.4 million, oregon $0.05 per share, compared with a nett nonaccomplishment of $5.8 million, oregon $0.07 per share, successful the Q1 of 2025.

The institution ended the 4th with astir $107.1 cardinal successful currency and currency equivalents.

SELLAS besides said it received an further $7.5 cardinal aft quarter-end from the workout of antecedently outstanding warrants.

SLS Price Action: SELLAS Life Sciences Gr shares were up 19.92% astatine $6.26 astatine the clip of work connected Wednesday, according to Benzinga Pro.