SELLAS Life Sciences Reports Full Year 2024 Financial Results and Provides Corporate Update

Core Insights - SELLAS Life Sciences Group, Inc. announced positive interim analysis results for its Phase 3 REGAL trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML), with the final analysis expected in 2025 [1][3] - The company reported promising data from the ongoing Phase 2 trial of SLS009 (Tambiciclib) in relapsed/refractory AML, with an overall response rate of 56% and a median overall survival exceeding 7.7 months [2][12] - SELLAS raised $25 million in gross proceeds from a registered direct offering in January 2025, enhancing its financial position [5][6] Clinical Development - The REGAL trial of GPS has shown preliminary signals of effectiveness, with fewer than 50% of enrolled patients confirmed deceased after a median follow-up of 13.5 months, indicating a median survival of over 13.5 months compared to the historical median of 6 months for conventional therapies [3] - The Phase 2 trial of SLS009 in AML has exceeded its prespecified target overall response rate of 33%, demonstrating a 56% response rate in patients with myelodysplasia-related changes [2][12] - Multiple regulatory designations were granted to SELLAS' programs in 2024, including FDA Rare Pediatric Disease Designations and Fast Track Designation, which may accelerate development and approval processes [2][8] Financial Performance - Research and development expenses for the year ended December 31, 2024, were $19.1 million, a decrease from $24.0 million in 2023, primarily due to reduced clinical trial expenses and a decrease in headcount [9] - General and administrative expenses decreased to $12.4 million in 2024 from $13.9 million in 2023, attributed to lower employee-related expenses and outside services [10] - The net loss for the year ended December 31, 2024, was $30.9 million, or a loss per share of $0.50, compared to a net loss of $37.3 million and a loss per share of $1.34 in 2023 [11][18] Cash Position - As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million, bolstered by the $25 million raised in January 2025 [13][5] Regulatory Achievements - The company received several regulatory designations for its therapies, including FDA Rare Pediatric Disease Designation for pediatric AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma [8]