SELLAS Life Sciences Group (SLS) 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA summary

Key pipeline updates and clinical progress

• GPS, a WT1-targeting immunotherapy, is in a pivotal phase III REGAL trial for AML, with top-line data expected soon after the 80th event is reached, a key catalyst for the company.

• SLS009, a selective CDK9 inhibitor, is in phase II for frontline AML, with top-line data on response rates and survival anticipated by year-end.

• GPS has shown strong survival benefits in prior phase II studies, including a median overall survival of 68 months in CR1 and 21 months vs. 5.4 months in CR2, with favorable safety and immune response profiles.

• The REGAL trial enrolled 126 AML patients in CR2, randomized to GPS or best available therapy, with extended GPS dosing based on physician feedback.

• SLS009 demonstrated high response rates (up to 50%) and median survival of 8.9 months in relapsed/refractory AML, including TP53-mutated patients.

Clinical trial design and market insights

• REGAL's primary endpoint is survival hazard ratio, powered at 90% for a HR of 0.636, with a projected 4+ month survival difference considered clinically significant.

• The 80th event in REGAL is delayed beyond initial projections, suggesting longer survival and potentially positive GPS impact.

• No approved maintenance therapies exist for AML CR2; GPS could become the standard, with potential expansion to CR1 and post-transplant settings.

• AML incidence is about 85,000 globally (22,000–27,000 in the US annually), with ~4,000 CR2 patients per year eligible for GPS.

• SLS009 is differentiated by high selectivity, favorable safety, and synergy with venetoclax, targeting urgent unmet needs in venetoclax-resistant AML.

Forward-looking statements and strategic outlook

• Top-line REGAL data will include primary endpoint results and survival metrics, with further guidance on timing after the 80th event.

• SLS009 phase II data may support accelerated approval or rapid progression to registrational studies, especially if CR rates exceed 30–40%.

• Predictive biomarker work may enable precision medicine approaches and expansion into solid tumors.

• GPS's favorable safety profile and immunogenicity position it for broad adoption in AML maintenance.

• Ongoing studies and upcoming data releases are expected to drive significant shareholder value in the next year.