SLS Stock Kicks Off Week In Green: CEO Flags Role In EU Biotech Policy Talks That Could Impact Drug Approvals

• The CEO called the talks “exceptionally constructive” and said the engagement was a “meaningful recognition” of the company’s work.
• Investor focus remains on the Phase 3 Regal trial evaluating GPS for AML, with 72 survival events recorded toward the 80-event topline trigger.
• Sellas is also seeking shareholder approval to expand its equity incentive plan by 20 million shares.

Shares of Sellas Life Sciences Group, Inc. (SLS) rose 2% on Monday after CEO Angelos Stergiou said the company was involved in talks with European lawmakers on biotech policy, even as investor focus stayed on its late-stage acute myeloid leukemia (AML) trial.

SLS stock closed above the $5 mark on Monday, returning to the level after a two-week gap.

Sellas Flags EU Biotech Act Talks

Stergiou said on LinkedIn that Sellas was invited to the European Parliament to meet members and healthcare experts from the Public Health Committee, where the company was asked to share its thoughts, insights, and recommendations on the EU Biotech Act, drug approval processes, market access, health economics, and the region’s competitiveness.

Stergiou called the discussions “exceptionally constructive” and said contributing to the EU Biotech Act dialogue was a “meaningful recognition” of the work being done at Sellas. “We had the opportunity to draw direct relevance from our pipeline, sharing how our innovative approaches to cancer therapies intersect with the need for forward-thinking, supportive legislation,” he said.  

Stergiou said the talks also focused on how policy decisions could affect the speed at which therapies reach patients. 

Sellas AML Trial Nears Topline Readout

The policy talks come as investor attention remains centered on Sellas’ ongoing Phase 3 Regal study evaluating GPS, an immunotherapy targeting the Wilms Tumor-1 antigen, as a maintenance treatment for patients with AML whose disease returned but later entered remission.

The event-driven trial is approaching the 80 overall-survival-event threshold required to trigger the topline analysis. The company previously said that 72 events had been recorded as of Dec. 26. Once the threshold is reached, Sellas plans to proceed with database lock, statistical analysis and unblinding of the study.

Stergiou has said that slower accumulation of survival events in oncology trials can sometimes indicate patients are living longer than initially expected. He also reiterated recently that his “conviction in the REGAL trial’s prospects and ultimate commercial potential remains as steadfast today as it was day 1.”

Sellas Seeks 20M Share Plan Boost

Separately, Sellas has asked shareholders to approve an expansion of its 2023 Amended and Restated Equity Incentive Plan by 20 million shares, aiming to replenish its stock-based compensation pool. The company said only 7,991 shares remained available for future awards as of mid-April. The approval would also allow a previously approved grant of 1.1 million restricted stock units to Stergiou to take effect.

As of April 15, Sellas reported 2.64 million stock options and 2.26 million restricted stock units outstanding, with total equity overhang representing about 2.6% of shares outstanding.

Beyond Regal, the company has pointed to 2026 as a key year for its CDK9 inhibitor SLS009, with clinical updates and topline data expected from ongoing Phase 2 studies. Preclinical findings showed that the therapy triggered programmed cell death in leukemia cells and remained active in AML associated with ASXL1 and TP53 mutations.

How Do Retail Traders Feel About SLS?

On Stocktwits, retail sentiment for SLS was ‘neutral’ amid over a 200% jump in 24-hour message volumes.

One user noted Stergiou’s LinkedIn post and said, “That is the footprint of a company stepping onto a much bigger stage. Add REGAL in the decisive stretch, SLS009 gaining weight, and the CEO speaking with total conviction, and the picture gets louder every day.”

Another user said, “Most unusual for a small Biotech company to address the EU Public Health Committee on Policy. Strong signal to institutional investors.”

SLS stock has surged 189% over the past year. 

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