A new study of 2,610 AML patients found a median survival of 11.4 months with Venetoclax-based therapy versus 8.2 months with hypomethylating drugs alone.

  • Venetoclax-based treatment was also associated with higher remission rates and fewer early deaths.
  • Comparisons with Regal are limited because the study examined newly diagnosed patients, while Regal enrolls patients in second complete remission.
  • Sellas reported 78 events as of May 11, two short of the threshold that triggers Regal’s final-analysis process.

Shares of Sellas Life Sciences (SLS) are on track to snap a two-week winning streak even as fresh leukemia research revived retail hopes for its cancer vaccine ahead of Regal’s final-analysis milestone.

SLS stock fell 0.3% on Wednesday to $11.31, marking its third consecutive session of losses and leaving shares down 4% for the week.

New AML Study Draws SLS Investors’ Attention

A study published in Leukemia compared venetoclax-based therapy with hypomethylating agents alone in newly diagnosed acute myeloid leukemia (AML) patients considered unfit for intensive treatment.

Researchers analyzed 2,610 AML patients and found that treatment built around Venetoclax, a targeted drug that blocks a protein helping cancer cells survive, was associated with a median survival of 11.4 months, compared with 8.2 months for hypomethylating drugs alone. Venetoclax-based treatment also helped more patients achieve remission and was associated with fewer early deaths.

However, comparisons with Regal have limits: the study involved newly diagnosed patients, while Regal enrolls patients whose leukemia returned and was brought back into remission through further treatment. 

Regal Nears Final-Analysis Threshold

Galinpepimut-S (GPS), Sellas’ experimental immunotherapy, targets the WT1 protein expressed in several cancers. Its Phase 3 Regal trial is evaluating the treatment in AML patients who have achieved a second complete remission.

In May, Sellas reported 78 events as of May 11, two short of the threshold required to trigger final analysis. The company reiterated in August that it would announce the 80th event, initiating database lock and blinded data review before statistical analysis, unblinding and disclosure of topline results. The extended wait has fueled speculation about patients living longer than anticipated. 

Beyond GPS, Sellas expects fourth-quarter topline data from its Phase 2 trial of SLS009 in newly diagnosed AML. As of August, 28 patients had enrolled in the planned 80-patient study, with enrollment and dosing ongoing. Last month, Sellas also reported promising SLS009 activity in lab-grown pancreatic cancer models derived from patients, including one resistant to the targeted drug Daraxonrasib. 

How Do Retail Traders Feel About SLS?

Stocktwits sentiment for SLS slipped to ‘bearish’ from ‘neutral’ levels a week ago amid a 16% decline in 24-hour message volumes. The research renewed discussion of “SuperBAT,” a retail term for the theory that unexpectedly strong survival among patients receiving best available treatment could explain Regal’s extended timeline. 

One user called the new research “the nail in the coffin for SuperBAT,” saying that survival outcomes in newly diagnosed AML were unlikely to improve in Regal’s second-remission population. The user said shares are trading at “peanut prices before lift off.”

Another user shared the study and highlighted supplementary comparisons of median and three-year survival among patients who achieved composite complete remission.

A separate user said the findings “lower the upper boundaries on BAT therapies,” while acknowledging that the research did not examine patients in second complete remission. Another bullish user declared, “Super BAT Game Over. GPS Cure coming.”

SLS stock has surged 200% year-to-date.

For updates and corrections, email newsroom[at]stocktwits[dot]com.<