Key Highlights
- SELLAS Life Sciences delivered a Q1 adjusted loss of $0.05 per share, surpassing Wall Street’s $0.07 estimate
- Shares of SLS jumped 20.4% during after-hours trading on Tuesday
- The company’s Phase 3 REGAL study of Galinpepimut-S for AML has recorded 78 of 80 required events for final data analysis
- Quarterly net loss expanded to $8.4 million compared to $5.8 million in the prior-year period, driven by increased R&D spending of $5.1 million
- Cash reserves stood at $107.1 million, with a $150 million at-the-market offering agreement established through TD Cowen
Shares of SELLAS Life Sciences (SLS) soared 20.4% in after-hours trading on Tuesday following the release of first quarter financial results that exceeded analyst projections and a significant update on the company’s pivotal cancer therapy trial.
SELLAS Life Sciences Group, Inc., SLS
During regular trading the next day, the stock maintained gains of approximately 15%, according to market data.
For the first quarter of 2026, SELLAS reported an adjusted loss of $0.05 per share, outperforming the Wall Street consensus estimate of $0.07. This earnings surprise sparked investor enthusiasm.
The company’s net loss expanded to $8.4 million during the quarter, compared to $5.8 million in the same period of 2025.
Research and development costs climbed to $5.1 million from $3.2 million year-over-year. Management explained the rise was primarily due to manufacturing activities and clinical trial investments in preparation for a possible Biologics License Application submission.
General and administrative costs similarly increased, reaching $4.1 million versus $2.9 million in last year’s first quarter.
Phase 3 REGAL Trial Nears Key Milestone
Perhaps more significant than the earnings beat was the progress update on the REGAL trial. This Phase 3 clinical study evaluating Galinpepimut-S for acute myeloid leukemia treatment has now documented 78 events as of May 11, 2026. The protocol stipulates 80 events must occur before the final data analysis can commence.
SELLAS maintains a blinded status regarding trial outcomes, meaning the actual efficacy data remains unknown to the company at this time.
Chief Executive Officer Angelos Stergiou characterized this development as “an important milestone” for SELLAS, acknowledging the dedication of trial participants, their caregivers, and the research teams involved.
Pipeline Candidate SLS009 Shows Promise
Beyond the REGAL program, SELLAS is advancing development of SLS009, its second experimental therapy. Preclinical data unveiled at the American Association for Cancer Research conference demonstrated the candidate’s activity against AML through inhibition of critical survival pathways, particularly in challenging genetic subtypes including TP53 and ASXL1 mutations.
The biotechnology firm has also initiated patient enrollment in a Phase 2 clinical trial evaluating SLS009 in newly diagnosed, first-line AML patients. This study focuses on individuals with limited likelihood of responding to conventional treatment approaches, including venetoclax-based regimens.
The company’s financial position appears robust ahead of anticipated data releases. SELLAS held $107.1 million in cash and cash equivalents at the end of March 31, 2026.
An additional $7.5 million in proceeds was generated during the second quarter through warrant exercise transactions.
SELLAS has also established an at-the-market equity offering program with TD Cowen, providing access to up to $150 million in potential capital. The company has not yet utilized this financing vehicle.
With the REGAL trial requiring just two more events before triggering final analysis, the upcoming corporate update will be closely monitored by the investment community.
