SELLAS Life Sciences 2022 Defined by Broad Success; Key Value-Driving Milestones Expected in 2023

SELLAS Life Sciences Group, Inc., (Nasdaq: SLS), has reported its full year 2022 financial results and provided a business update.

SELLAS described 2022 as a year of broad success with positive efficacy demonstrated across its clinical programs and continued expansion of the company’s development pipeline.

The company’s share price rose more than 17% in pre-market trading on Tuesday.

Clinical highlights

•  Enrollment in SELLAS’ Phase 3 REGAL study in acute myeloid leukemia (AML) is ongoing and remains on track for interim analysis by late 2023/early 2024.
• An investigational new drug (IND) application was approved by China’s National Medical Products Administration for the first clinical trial for SELLAS’ lead candidate, GPS, in China. The open-label, single-arm, multi-center Phase 1 clinical trial in patients with AML, multiple myeloma, non-Hodgkin’s lymphoma, or higher-risk myelodysplastic syndrome has now been initiated.
• In November, SELLAS released topline data showing clinical benefit of GPS in combination with pembrolizumab (Keytruda®) in ovarian cancer in a Phase 1/2 study.
• Patient enrollment was completed in the company’s Phase 1 study evaluating a potential treatment for malignant pleural mesothelioma (MPM) at the end of 2022. SELLAS expects to report topline data during the first half of 2023.
• GFH009 was selected for the National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program. As part of the program, PIVOT principal investigators at eight participating research institutions will evaluate GFH009 against pediatric solid tumors and leukemia models.

 Financial highlights

• Licensing revenue for the year ended December 31, 2022 was $1.0 million.
• The company ended the quarter with cash and cash equivalents totaling approximately $17.1 million (as of December 31, 2022).
• An additional $13 million milestone payment from 3D Medicines, the company’s development and commercialization partner for Greater China, is expected in the first half of 2023.

 About SELLAS Life Sciences

SELLAS is a late-stage clinical biopharmaceutical company developing novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing GFH009, a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China.