SLS Stock Heads For Their Best Month This Year Ahead Of Key AML Trial Readout

• Sellas recently said its late-stage Regal trial of GPS in AML is only two events away from reaching the topline data readout stage.
• For the first quarter, Sellas’ net loss widened largely due to increased R&D spending ahead of a potential FDA filing for GPS.
• Sellas had earlier stated that the trial would be considered a success if GPS extends median overall survival to 12.6 months versus 8.1 months with standard care.

Shares of Sellas Life Sciences Group (SLS) are on track for their biggest monthly gains of the year as investors ramp up bullish bets ahead of the company’s pivotal final data readout in acute myeloid leukemia.

SLS shares were up around 1.5% in pre-market trading on Tuesday, having gained more than 57% through Friday’s close.

REGAL Trial Nears Critical Data Milestone

On May 13, Sellas shares recorded their biggest intraday gains of the month after the company said its late-stage Regal trial of Galinpepimut-S (GPS) in acute myeloid leukaemia (AML) is only two events away from reaching the topline data readout stage. The study has recorded 78 deaths, and the planned analysis will begin once the 80th event is reached.

For the first quarter (Q1), Sellas net loss widened to $8.4 million, largely due to increased R&D spending as it prepares for a potential U.S. Food and Drug Administration (FDA) filing for GPS following the REGAL trial readout.

Delayed Final Readout Hints At Success

Speaking at A.G.P.’s Annual Virtual Healthcare Conference last week, CEO Angelos Stergiou said survival trends in the Regal study appear stronger than expected, adding that the delayed timing of the final event could improve GPS’s chances of success.

Sellas previously said the REGAL trial would likely be considered successful if GPS improves median overall survival to 12.6 months, compared with 8.1 months for standard care.

Stergiou also added that the company plans to move quickly toward a pre-BLA (Biologics License Application) meeting with the FDA and a potential filing if the REGAL trial reports positive results. He added that a successful outcome could position GPS as the first approved maintenance immunotherapy for AML patients in second remission.

What Do Retail Traders Think About SLS?

Retail sentiment for SLS on Stocktwits has trended in the ‘extremely bullish’ territory for at least a week, while message volumes on the platform were ‘high.’

One user called the highly anticipated 80th event “one of the biggest near-term biotech catalysts on the market right now.”

Retail traders also latched onto Stergiou’s LinkedIn post comparing Sellas’ journey to the New York Knicks reaching their first Eastern Conference Finals appearance since 1999, with some investors interpreting the analogy as a confidence signal ahead of the REGAL readout.

A user called Stergiou’s message about the Knicks reaching the Eastern Conference Finals “without a doubt a direct message to all shareholders.”

The stock has gained more than 185% so far this year.

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