SLS Stock Jumps Premarket: CEO Says GPS AML Data Has ‘Very Good Chance’ To Beat Earlier Survival Outcomes

• Stergiou said the delayed timeline for reaching the final event trigger has increased optimism for the Regal trial.
• The CEO also disclosed that some Regal patients remain on treatment more than three years after enrollment.
• Investors are also watching Sellas’ second AML drug, SLS009, which the company is developing for venetoclax-resistant AML.

Shares of Sellas Life Sciences Group (SLS) jumped 7% in premarket trading on Wednesday after CEO Angelos Stergiou said that there is “a very good chance” its acute myeloid leukemia (AML) drug GPS could replicate or even outperform earlier survival data as the closely watched Regal Phase 3 trial nears its final readout.

SLS stock jumped over 4% on Tuesday to end at $7.59.

Sellas CEO Bullish On GPS Trial Readout

Investors are watching Sellas’ Phase 3 Regal trial evaluating Galinpepimut-S (GPS) in AML patients who entered remission following second-line salvage therapy. The company recently disclosed that the study had reached 78 events as of May 11, leaving only two events remaining before the trial reaches the threshold required for final analysis and topline data release.

Speaking at the Stifel 2026 Targeted Oncology Virtual Forum on Tuesday, Stergiou cited the delayed timeline to the study’s final event trigger as one of the reasons the company has become more optimistic. “The initial assumption was, once the last patient was enrolled, which happened around March of 2024, we expected between 12 to 15 months or so to hit the 80th event. Obviously, that has surpassed the timing,” Stergiou said.

Stergiou said that the company is blinded to the Regal study results, while noting that Sellas believes GPS could be contributing to the extended survival seen in patients, similar to findings from earlier studies in first complete remission (CR1) and second complete remission (CR2) AML settings. 

“My personal belief is that there's a very good chance that GPS will mimic survival data, what we had seen in the phase II study, and potentially even better,” he added. 

Final AML Events Put Data Weeks Away

The Regal study enrolled 126 AML patients who had entered a second remission after their disease returned and were treated again. The trial is comparing GPS against currently available treatment options in a randomized study to measure whether patients live longer overall. According to Sellas, the study would be considered successful if GPS helps extend median overall survival to about 12.6 months, compared with 8.1 months for patients receiving standard treatment. 

“Again, when the 80th event materializes, we will inform the public, which represents a very important near-term catalyst for SELLAS,” Stergiou said. When asked about timing for topline results after the final event is reached, Stergiou said: “I would expect, once the 80th event happens with all the final clear resolutions and cleaning of the data, it's gonna be a few weeks.”

The company has highlighted prior GPS data as investors attempt to gauge the likelihood of success in Regal. Earlier studies in AML patients after first complete remission showed a median overall survival of 67.6 months, while a second complete remission study showed survival of 21 months compared with 5.4 months in control patients. “This activity is indeed unprecedented,” Stergiou said.

Stergiou also disclosed that some Regal patients continue receiving GPS treatment three years after enrollment, which has further fueled investor speculation around survival in the study. The CEO added that a successful Regal outcome could position GPS as the first approved maintenance immunotherapy in AML.

Sellas Bets On SLS009 In Resistant AML

While Regal remains the company’s main near-term catalyst, investors are also tracking developments around Sellas’ second AML drug, SLS009, a highly selective CDK9 inhibitor currently in Phase 2 testing. The company has already started dosing patients in studies evaluating SLS009 in newly diagnosed high-risk AML patients carrying TP53 and ASXL1 mutations, which are patient populations typically associated with poor outcomes under standard treatment.

Stergiou called the drug’s activity “quite astonishing” during the Stifel conference. Sellas has positioned SLS009 as a potential treatment option for venetoclax-resistant AML, an area of growing focus across the leukemia landscape. “There are also no patients who do not develop resistance to venetoclax at some point,” Stergiou said.

“SLS009 interestingly exhibits an extraordinary synergy with venetoclax and has the ability to both improve response to venetoclax or even convert complete resistance to venetoclax into a strong response,” he added.

How Do Retail Traders Feel About SLS?

On Stocktwits, retail sentiment for SLS was ‘extremely bullish’ amid a 554% surge in message volumes over the past month.

One user said, “laying this all out, it is 1000% clear that REGAL IS a success for GPS. Only the GPS treated participants are still alive. Buy all that you can. This is not a drill.”

Another user said, “couldn't sleep, i plan to add even more tomorrow, imo even at $8 this is a 10x by EOY or 1Q27”

SLS stock has surged 334% over the past year. 

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