SELLAS Life Sciences Group, Inc.SLS
What SELLAS Life Sciences Group, Inc. does.
We are a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. Our product candidates currently include galinpepimut-S, or GPS, a peptide immunotherapy directed against the Wilms tumor 1, or WT1, antigen, and SLS009 (tambiciclib), a highly selective small molecule cyclin-dependent kinase 9, or CDK9, inhibitor.
Our lead product candidate, GPS, is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center, or MSK, that targets the WT1 protein, which is present in 20 or more cancer types. Based on its mechanism of action as a directly immunizing agent, GPS has potential as a monotherapy or in combination with other immunotherapeutic agents to address a broad spectrum of hematologic, or blood, cancers, and solid tumor indications.
We have an ongoing open label randomized Phase 3 clinical trial, the REGAL study, for GPS monotherapy in patients with acute myeloid leukemia, or AML, in the maintenance setting after achievement of second complete remission, or CR2, following successful completion of second-line antileukemic therapy. Patients are randomized to receive either GPS or best available treatment, or BAT. We expect this study will be used as the basis for submission of a Biologics License Application, or BLA, subject to a statistically significant and clinically meaningful trial outcome and agreement with the U.S. Food and Drug Administration, or the FDA. The primary endpoint of the REGAL study is overall survival, or OS. We planned to enroll approximately 125 to 140 patients at approximately 95 clinical sites in North America, Europe and Asia with a planned interim safety, efficacy and futility analysis after 60 events (deaths). In March 2024, we announced the completion of enrollment. In December 2024, we announced that the pre-specified threshold of 60 events (deaths) per the protocol had been reached, triggering the interim analysis to be conducted by the Independent Data Monitoring Committee, or IDMC. In January 2025, we announced that the IDMC had completed pre-specified interim analysis of the REGAL study and had recommended that the study continue without modifications. The next and final analysis will be conducted once 80 events (deaths) are reached. In December 2025, we announced that our contract research organization informed us that the pooled number of events was 72 as of December 26, 2025. We remain blinded to all efficacy and survival data outcomes and, as no outcomes analyses were performed and no statistical penalty has been incurred, this one-time update on the aggregate number of events does not impact future statistical analyses. Because the final analysis is event driven, it is difficult to predict with any certainty and it may occur at a different time than currently expected. We will announce the 80th event when it occurs.
Revenue and profit, by fiscal year.
| Fiscal year | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|
| Revenue | $1.9M | $7.6M | $1.0M | $0 | — | — |
| Net income | -$16.8M | -$20.7M | -$41.3M | -$37.3M | -$30.9M | -$26.9M |
| Free cash flow | — | — | — | — | — | — |
More on SLS.
- SELLAS Life Sciences Group, Inc. summary
- SELLAS Life Sciences Group, Inc. financial statements
- SELLAS Life Sciences Group, Inc. key metrics
- SELLAS Life Sciences Group, Inc. health scores and style box
- SELLAS Life Sciences Group, Inc. earnings
- SELLAS Life Sciences Group, Inc. dividends
- SELLAS Life Sciences Group, Inc. valuation
- SELLAS Life Sciences Group, Inc. ownership and insiders
- SELLAS Life Sciences Group, Inc. peers
Figures from SELLAS Life Sciences Group, Inc.'s filings with the U.S. SEC, standardised automatically; prices are end-of-day closes. Not financial advice.