SLS Stock In The Spotlight As CEO Pushes Back On Regal Trial Criticism – ‘Let’s Separate The Noise From The Data’

CEO Angelos M. Stergiou addressed concerns over the company’s trial to treat acute myeloid leukemia.

• Stergiou rejected claims that the trial delay means patients in the control group are living longer because of newer treatments, saying there is no approved maintenance therapy for a second complete remission.
• He said valuing the company based only on GPS’s potential sales overlooks the broader value of the company’s pipeline.
• The Regal trial of Galinpepimut-S has reached 78 of the 80 events required to trigger the final data readout.

Sellas Life Sciences (SLS) generated significant buzz on Wednesday after CEO Angelos M. Stergiou addressed concerns over the company’s pivotal Phase 3 trial to treat acute myeloid leukemia (AML), as the study nears its final analysis.

Investors are closely watching the Regal trial of Galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML), which has reached 78 of the 80 events (deaths) required to trigger the final data readout.  

SLS stock was down nearly 7% at the time of writing, tracking a third consecutive session of declines.

CEO Says Intensive Therapies Could Shorten Survival

Stergiou rejected claims that the trial delay means patients in the control group are living longer because of newer treatments, saying there is no approved maintenance therapy for second complete remission (CR2).

He added that therapies like Venetoclax-based regimens are not standard for the patients and can cause severe side effects, with real-world data showing no meaningful improvement in survival.

The CEO said it may likely be his final brief posting around the Regal trial before the critical 80th event. “Let’s separate the noise from the data. This may likely be my last brief posting around REGAL before we approach the critical 80th event (will be announced) and enter an official quiet period until topline results,” Stergiou said in a LinkedIn post on Wednesday.

Stergiou Says Valuation Based On Potential GPS Sales Overlooks Broader Pipeline

Stergiou said the slower pace of event accumulation could reflect the effectiveness of GPS rather than longer survival in the control group, as immunotherapies can produce durable long-term survival benefits over time. He also rejected suggestions to stop the trial at 78 events, saying completing the planned 80 events is essential to maintain the study's statistical integrity and satisfy regulatory standards.

Speaking on valuations, Stergiou said that valuing the company solely on GPS’s potential sales overlooks the broader value of its pipeline. He pointed to SLS009 therapy being developed for multiple cancers and the strategic value of its late-stage assets as key factors that are not fully reflected in traditional valuation models.

Retail Expects SLS Stock To Skyrocket

Retail sentiment surrounding SLS remained in the ‘bullish’ territory over the past 24 hours, amid ‘high’ message volumes.

One user expects the stock to “skyrocket.”

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The stock has gained nearly 190% so far this year.

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