SELLAS LIFE SCIENCES GROUP INC (SLS)

Weekly Summary (2025-05-12)

Highlights

Positive overall survival data in cohort 3 from the ongoing Phase 2 trial of SLS009 in r/r AML, demonstrating a median OS of 8.9 months in AML-MRC and 8.8 months in all r/r patients.
67% overall response rate (ORR) in patients with AML-MRC and 46% in all evaluable patients, significantly exceeding the targeted 20% ORR.
Promising preclinical efficacy of SLS009 in TP53 mutated AML and ASXL1 mutated colorectal cancer.
Positive outcome of interim analysis for Phase 3 REGAL trial of GPS in AML, allowing the trial to advance toward completion.
Raised $25 million from a registered direct offering, strengthening financial position.

Challenges

Continued reliance on clinical trial outcomes for future growth and validation of SLS009 and GPS.
Potential regulatory hurdles and market competition in the biopharmaceutical sector.

Catalysts

Full topline Phase 2 data of SLS009 anticipated soon.
Final analysis of the Phase 3 pivotal REGAL trial of GPS expected later this year.
Presentation of preclinical efficacy data at ASCO 2025 on June 2, 2025.

Outlook

SELLAS Life Sciences is well-positioned for an exciting 2025 with promising data across its pipeline and significant upcoming milestones.

Upcoming Events

May 30, 2025, 5:00:00 AM UTC

ASCO Annual Meeting

The 2025 ASCO Annual Meeting will take place from May 30 to June 3, 2025, in Chicago, Illinois, featuring various oncology presentations.

other

Jun 2, 2025, 6:30:00 PM UTC

ASCO Presentation on SLS009 Efficacy

SELLAS Life Sciences will present preclinical efficacy data for SLS009 in ASXL1 mutated colorectal cancer at the ASCO Annual Meeting.

conference talk

Jun 30, 2025, 4:00:00 AM UTC

FDA Regulatory Path Feedback Expected

SELLAS Life Sciences anticipates feedback from the FDA regarding the regulatory path for SLS009 in 1H 2025, following promising trial results in AML patients.

fda decision

Jul 1, 2025, 4:59:59 AM UTC

Full Data and FDA Regulatory Path Feedback for SLS009

SELLAS expects to report full data and FDA regulatory path feedback for SLS009 (Tambiciclib) in r/r AML in the first half of 2025, marking a significant milestone for the drug.

clinical readout

Jan 1, 2026, 4:59:59 AM UTC

Final Analysis of Phase 3 REGAL Trial of GPS in AML

SELLAS anticipates the final analysis of its Phase 3 REGAL trial of Galinpepimut-S (GPS) in AML upon reaching 80 events, expected in 2025, which could lead to regulatory approval.

clinical readout