Sellas CEO Stergiou Says ‘Rigorous, Unblinded’ Data From Pivotal AML Trial Will 'Speak For Itself' As REGAL Catalyst Nears

• Stergiou did not provide a new event count or timeline.
• The CEO had previously said the company had entered a quiet period while preparing for the database lock and regulatory work.
• SLS shares are set to gain for a fourth time in five weeks.

Sellas Life Sciences (SLS) CEO Angelos Stergiou said on Monday that the biotech firm will let the unblinded results from its pivotal Phase 3 Regal trial “speak for itself” amid growing speculation as the closely watched acute myeloid leukemia (AML) study approaches its final trigger.

At the time of writing, SLS shares gained 1.5% and are on track for a fourth gain in five months.

Stergiou Says Objective Data Will Provide Answers

In a post on LinkedIn on Monday, Stergiou said speculation and outside commentary are naturally increasing as key trial results approach, but the company will let the data speak for itself.

“As major clinical trial catalysts approach, market noise, speculation, and third-party commentary naturally intensify. Over the past months and years, we and respected key opinion leaders have extensively discussed corporate matters, scientific principles, clinical rationale, and the design of our programs,” Stergiou said.

“At this juncture, our philosophy is simple: we will ultimately allow the rigorous, unblinded clinical data from REGAL to speak for itself - objective data will provide the answers - a fundamental principle of operating at the forefront of medicine,” he added.

However, he did not provide a new event count or timeline. Regal is evaluating GPS as a maintenance treatment for AML patients in their second complete remission.

Replying to a LinkedIn post by Healthspan AI adviser Stuart Diamond, which focused on Moderna and Merck’s personalized mRNA cancer vaccine, Rob Tomko, a medical-device industry executive, said Sellas Life Sciences will be on the map in a major way soon.

The Regal study has recorded 78 of the 80 deaths required to trigger its final analysis. Sellas will consider the trial successful if patients receiving GPS achieve a median overall survival of 12.6 months, compared with eight months for the control group.

CEO Angelos Stergiou previously said the company had entered a quiet period while preparing for the database lock and regulatory work.

Retail’s Take On SLS

Meanwhile, retail sentiment surrounding SLS on Stocktwits turned ‘neutral’ from ‘bullish’ over the past 24 hours.

One bullish user said they were “highly excited” by the LinkedIn post.

The stock has gained more than 208% so far this year.

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