Key Takeaways
- SELLAS Life Sciences delivered a Q1 adjusted loss of $0.05 per share, outperforming Wall Street’s $0.07 estimate
- Shares of SLS soared 20.4% in extended trading on the news
- The company’s critical Phase 3 REGAL study evaluating Galinpepimut-S for AML has reached 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 at quarter-end, with a $150 million ATM offering arrangement available through TD Cowen
Shares of SELLAS Life Sciences (SLS) exploded 20.4% in after-hours trading Tuesday following the biotechnology firm’s better-than-anticipated first quarter financial results and a crucial update on its late-stage cancer trial.
SELLAS Life Sciences Group, Inc., SLS
During the subsequent trading session, the stock maintained gains of approximately 15%, according to market data.
For the first quarter of 2026, SELLAS reported an adjusted loss per share of $0.05, surpassing analyst expectations of a $0.07 loss. The earnings beat sparked immediate investor enthusiasm.
The company’s net loss for the three-month period grew to $8.4 million versus $5.8 million during the comparable quarter in 2025.
Research and development expenditures climbed to $5.1 million from $3.2 million on a year-over-year basis. SELLAS explained that the uptick reflects manufacturing costs and clinical trial activities in anticipation of a possible Biologics License Application submission.
General and administrative costs also rose, reaching $4.1 million compared to $2.9 million in last year’s first quarter.
REGAL Study Nears Data Trigger Point
Perhaps more significant than the earnings beat is the progress update on the REGAL trial. The Phase 3 clinical study testing Galinpepimut-S in patients with acute myeloid leukemia has documented 78 events as of May 11, 2026. Just 80 events are needed to initiate the final statistical analysis.
SELLAS continues operating under blinded conditions, which means the company currently has no visibility into whether the trial is demonstrating efficacy.
Chief Executive Officer Angelos Stergiou described the progress as “an important milestone” for SELLAS, acknowledging the dedication of trial participants, their caregivers, and clinical investigators.
SLS009 Program Moves Forward
Beyond REGAL, SELLAS is advancing its second drug candidate, SLS009. Preclinical data unveiled at the American Association for Cancer Research conference demonstrated effectiveness against AML by inhibiting critical survival pathways, including in high-risk genetic mutations such as TP53 and ASXL1.
The company has already initiated patient enrollment in a Phase 2 clinical trial evaluating SLS009 in newly diagnosed, frontline AML cases. This trial targets patients who are unlikely to respond to conventional treatment approaches, including venetoclax-based regimens.
The financial runway appears robust as these catalysts approach. SELLAS held $107.1 million in cash and cash equivalents at the end of March 2026.
An additional $7.5 million was secured during the second quarter through warrant exercise proceeds.
The biotechnology company maintains an at-the-market equity distribution agreement with TD Cowen, providing access to up to $150 million in capital if needed. To date, no shares have been issued under this arrangement.
With the REGAL trial standing just two events away from unlocking final efficacy data, the next company announcement will be closely monitored by market participants.
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