SELLAS Life Sciences Q2 2024 Financial Results and Corporate Update

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, has announced its financial results for the second quarter ending June 30, 2024, and provided an update on its corporate progress. The company specializes in developing novel therapies for various cancer types and has shown significant advancements in its clinical programs.

Dr. Angelos Stergiou, President and CEO of SELLAS, expressed satisfaction with the company's second-quarter performance, highlighting promising early data from their Phase 2a SLS009 trial for acute myeloid leukemia (AML). The trial showed an overall response rate (ORR) of 33%, 50%, and 100% across different dosage cohorts, significantly surpassing the target ORR of 20% and median overall survival of over three months. The trial has been expanded to include patients with ASXL1 mutations and other myelodysplasia-related changes.

The European Medicines Agency (EMA) has granted orphan drug designations for SLS009 in AML and peripheral T-cell lymphomas (PTCL). Additionally, the U.S. FDA has provided rare pediatric disease designations for pediatric AML and acute lymphoblastic leukemia (ALL). SELLAS recently completed a $21 million capital raise, enhancing its financial stability and enabling the company to achieve several key data milestones.

Regarding the Phase 3 REGAL study, which focuses on their lead product candidate galinpepimut-S (GPS) in AML, an Independent Data Monitoring Committee (IDMC) recommended the trial's continuation without modifications following an efficacy and safety assessment. The IDMC anticipates that the interim analysis, triggered by 60 events, will occur by the fourth quarter of 2024.

The pipeline highlights include:
- Galinpepimut-S (GPS): A Wilms Tumor-1 (WT1) targeting immunotherapeutic. The Phase 3 REGAL study in AML is progressing well, with the IDMC's recent risk-benefit assessment indicating no need for modifications. The interim analysis is anticipated by Q4 2024.
- SLS009: A highly selective and specific CDK9 inhibitor. The Phase 2a trial for relapsed or refractory AML has completed enrollment ahead of schedule, involving 30 patients across five U.S. centers. The initial data shows promising ORR and median overall survival benefits, particularly in patients with ASXL1 mutations. SLS009 was well-tolerated across all doses tested.

Further development in SLS009 includes new cohorts for AML with myelodysplasia-related changes and specific pediatric patient enrollments. The National Institute of Health's PIVOT program in pediatric tumors continues, with initial safety and efficacy data expected in the latter half of 2024. The FDA and EMA have granted various regulatory designations to SLS009, recognizing its potential in treating pediatric and adult cancers.

Financially, SELLAS reported research and development expenses of $5.2 million for Q2 2024, down from $5.9 million in the same period in 2023. General and administrative expenses also decreased to $2.4 million from $3.1 million year-over-year. The net loss for Q2 2024 was $7.5 million, an improvement from $8.8 million in Q2 2023. As of June 30, 2024, the company's cash and cash equivalents stood at approximately $9.1 million, bolstered by the $21 million raised subsequently through a registered direct offering.

SELLAS Life Sciences Group, Inc. continues to make strides in cancer therapy development, with a strong focus on its flagship products, GPS and SLS009. These advancements, along with solid financial management, position the company for continued success in the biopharmaceutical sector.

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