SELLAS Life Sciences Reports $30.9 Million Net Loss for 2024, Decreased Operating Expenses

SELLAS Life Sciences Group, Inc. reported a net loss of $30.9 million for the year ended December 31, 2024, compared to a net loss of $37.3 million in 2023. Total operating expenses decreased by $6.4 million to $31.5 million in 2024, primarily due to a reduction in research and development expenses, which fell by $4.9 million to $19.1 million. This decrease was largely attributed to the completion of enrollment in the REGAL Phase 3 clinical trial for galinpepimut-S (GPS) in the first quarter of 2024, resulting in lower clinical trial, manufacturing, and consulting costs. General and administrative expenses also decreased by $1.5 million to $12.4 million.

The company's lead product candidate, GPS, is a WT1-targeting peptide immunotherapy currently in a Phase 3 trial for AML. Enrollment in this trial concluded in March 2024, and an interim analysis in January 2025 recommended continuation of the study. SELLAS has licensed GPS to 3D Medicines for development and commercialization in Greater China, receiving $10.5 million in upfront and milestone payments to date. A binding arbitration proceeding was initiated against 3D Medicines in December 2023 regarding milestone payments and development efforts. The company also completed a Phase 1 trial for its second product candidate, SLS009, a CDK9 inhibitor, and initiated a Phase 2a trial in combination with venetoclax and azacitidine for relapsed/refractory AML. Positive preliminary data from this trial were announced in May and December 2024.

As of March 19, 2025, SELLAS had 73,977,459 shares of common stock outstanding. The aggregate market value of common stock held by non-affiliates on June 30, 2024 was $68.6 million. The company had 15 full-time employees as of March 1, 2025. SELLAS has secured Orphan Drug Designations and Fast Track designations from the FDA for both GPS and SLS009 in various indications, including AML. Additionally, the FDA granted Rare Pediatric Disease designations for GPS and SLS009 in pediatric AML.

The company's financial statements include an emphasis of matter paragraph expressing substantial doubt about its ability to continue as a going concern due to recurring losses and a net capital deficiency. To address this, SELLAS completed several registered direct offerings in 2024 and 2025, raising significant capital. The company anticipates continued losses for the foreseeable future and will require additional funding to support its operations. The company's outlook is contingent upon the successful development, regulatory approval, and commercialization of its product candidates. Further, the company's financial statements are prepared assuming it will continue as a going concern, and do not include adjustments that might be necessary if this assumption proves incorrect.

SELLAS's operations are subject to various risks, including those related to clinical trial outcomes, regulatory approvals, manufacturing, intellectual property, competition, and financing. The company's future success depends on several factors, including the successful completion of clinical trials, obtaining regulatory approvals, securing market acceptance for its products, and establishing effective commercialization strategies. The company's financial statements and related disclosures require significant estimates and judgments, particularly regarding revenue recognition, goodwill impairment, and stock-based compensation.