On August 11, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"The second quarter was an important period of execution for SELLAS as we continued to advance both of our lead clinical programs, GPS and SLS009," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "For GPS, we are approaching the pre-specified 80th event in the Phase 3 REGAL trial marking a critical step toward the final efficacy analysis and, if successful, a potential BLA submission to the FDA. At the same time, we are making meaningful progress with SLS009 in our ongoing Phase 2 frontline AML study, where dosing continues and enrollment is tracking ahead of industry standards, with topline data expected in the fourth quarter of 2026. In addition, we have obtained promising results from preclinical studies in pancreatic ductal adenocarcinoma (PDAC) and intend to support clinical development at a top-tier academic institution. Together, these programs reflect our commitment to developing differentiated therapies that may address significant unmet needs for patients with AML and support meaningful long-term value creation for SELLAS."

Recent Corporate Highlights:
Phase 3 REGAL Trial of GPS: Ongoing Phase 3 trial in AML patients who have achieved complete remission following second-line salvage therapy. The Company will announce when the required pre-specified 80th event occurs, which will trigger the customary database lock, blinded data review procedures before statistical analysis, unblinding, and disclosure of topline results.

Ongoing dosing of SLS009 in earlier-line AML: 28 patients have been enrolled, and enrollment and dosing continue in the ongoing 80-patient Phase 2 trial in newly diagnosed AML patients, including those who become refractory early to AZA/VEN treatment identified through extensive transcriptomics, genomics, and proteomics models. Topline data expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

Potential expansion of SLS009 into solid cancers: SLS009 has demonstrated the ability to act as a single agent in PDAC cells largely resistant to leading RAS inhibitors and synergize with the RAS inhibition mechanism of action. The data from these preclinical experiments are expected to be presented at an upcoming medical conference.

Financial Results for the Second Quarter 2026:

Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2026, were $6.3 million, compared to $3.9 million for the same period in 2025. Research and development expenses in the first half of 2026 were $11.4 million compared to $7.1 million for the same period in 2025. The increase was primarily due to increases in manufacturing costs, clinical and regulatory consulting, and clinical trial expenses in preparation for a potential Biologics License Application (BLA) for GPS following the final analysis of the REGAL study.

General and Administrative Expenses: General and administrative expenses for the second quarter of 2026 were $4.4 million, as compared to $3.0 million for the same period in 2025. General and administrative expenses in the first half of 2026 were $8.5 million compared to $5.9 million for the same period in 2025. The increase was primarily due to increases in professional fees and non-cash stock-based compensation.

Net Loss: The net loss was $9.6 million for the second quarter of 2026, or a basic and diluted loss per share of $0.05, as compared to a net loss of $6.6 million for the second quarter of 2025, or a basic and diluted loss per share of $0.07. The net loss was $18.0 million for the first half of 2026, or a basic and diluted loss per share of $0.10, as compared to a net loss of $12.4 million for the second quarter of 2025, or a basic and diluted loss per share of $0.13.
Cash Position: As of June 30, 2026, cash and cash equivalents totaled approximately $138.3 million.

(Press release, Sellas Life Sciences, AUG 11, 2026, View Source [SID1234669945])