SELLAS Life Science

SELLAS Life Science Disclosure: This is NOT a traditional Graham and Dodd value investment. (No pharma company is) It is an event driven opportunity. Very soon, almost any day, SELLAS will reach data lock on their a phase 3 REGAL trial for AML (Lou Gehrig's Disease) in second complete remission. The trial enrolled 125 patients. First patient in Feb. 2021- Last in April 2024. End point is overall survival (OS). The trial will data lock when 80 patients have died. On May 11 they announced 78 of the required 80 events have occurred. When 2 more pass away the data will be locked and top line results will be announced, typically anywhere from 3 days to 5 weeks after data lock. In January of last year SLS announced the results of an interim analysis, conducted after 60 patients had passed away. The result indicated an overall survival of between 12-13.5 months for the analysis cohort, versus 6 months with current std. treatment. That's an encouraging read at 60 deaths. The trial will be successful if the median OS is 12.6 months or higher. TAM for the indication (AML second complete remission) is estimated to be 9000 patients in the US which is a peak mkt. in the 100's of millions. But what often happens (and most certainly will if this trial is successful) is that if a trial is successful in subgroup population a company will seek a label expansion to reach additional patient populations. The world wide TAM for AML is currently estimated to be between 3.2 and 4.2 billion dollars and expected grow at about a 10% CAGR for the next decade. In short, SLS is about to reach data lock any day, with top line results releases 3 days to 5 weeks later. With the favorable interim analysis data, it seems reasonable to believe that the trial will reach its endpoint.