SELLAS Life Sciences Reveals Ambitious Plans for 2025

SELLAS Life Sciences Unveils Strategic Focus for 2025

- An Independent Data Monitoring Committee will conduct an interim analysis of the Phase 3 REGAL Study in early 2025.

- Full topline data for SLS009 in acute myeloid leukemia (AML) and FDA review are anticipated in the first half of the year.

- The name 'tambiciclib' has been officially assigned as the recommended International Nonproprietary Name for SLS009.

- The company seeks non-dilutive grant funding to bolster the development of SLS009 for frontline AML treatment.

- Initiatives are underway to establish pediatric programs for SLS009 targeting various hematological disorders.

NEW YORK -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a prominent player in the late-stage biopharmaceutical sector, is dedicated to pioneering novel therapies aimed at treating various forms of cancer. Today, the Company shared its strategic business objectives for 2025 and announced a corporate webinar scheduled for early in the year.

Angelos Stergiou, MD, ScD h.c., the Company’s President and CEO, expressed confidence in the upcoming year. "We are poised for a pivotal year as we advance our clinical initiatives in innovative therapeutics for hematologic malignancies. Building on our achievements from 2024, we are enthusiastic about the transformative clinical milestones that lie ahead," he stated.

In 2025, SELLAS anticipates receiving full topline results from the Phase 2 clinical trial of SLS009, particularly for AML patients who have shown resistance to other treatments like venetoclax. Additionally, feedback from the FDA regarding the regulatory pathway for SLS009 is expected shortly. The interim analysis of the Phase 3 REGAL study will be conducted by an Independent Data Monitoring Committee, which will offer pivotal recommendations on the trial's future direction based on initial outcomes.

Recognizing the urgency of medical needs, Dr. Stergiou noted that regulatory agencies have acknowledged the potential of SELLAS’s therapeutic candidates. In 2024, the FDA granted Rare Pediatric Disease Designation for pediatric AML and SLS009, confirming the Company’s commitment to addressing critical health challenges.

Focused Objectives and Highlighted Milestones for 2025

Galinpepimut-S (GPS) Progress

SELLAS's leading immunotherapeutic asset, GPS, which targets the Wilms Tumor-1 (WT1) antigen, will progress through its Phase 3 REGAL study, aimed at AML patients who have been through intensive treatments. The results from the ongoing interim analysis in early 2025 will determine the trial's trajectory, allowing for necessary adjustments based on efficacy or futility.

Key Developments Around SLS009

SLS009 is a targeted CDK9 inhibitor that is projected to produce valuable data from its Phase 2 study in AML. Full topline results from various cohorts, including those with ASXL1 mutations, are expected in the first half of 2025. Anticipation surrounding the FDA’s feedback on the regulatory route for this study has also heightened interest among stakeholders.

Achievements of 2024

Galinpepimut-S Updates

SELLAS successfully initiated the interim analysis of the Phase 3 REGAL study after reaching a significant threshold in its clinical trial metrics. This achievement paves the way for valuable insights into the study's prevailing therapeutic efficacy.

Progress in SLS009 Development

In a noteworthy milestone, the World Health Organization approved 'tambiciclib' as the International Nonproprietary Name for SLS009. Reported outcomes from the ongoing Phase 2 trial have shown that SLS009 provides promising survival rates for patients with historically low median overall survivability.

Regulatory Designations and Continued Growth

SELLAS continues to navigate the regulatory landscape effectively, garnering notable designations that include FDA Rare Pediatric Disease Designation and orphan drug designations, underscoring the unmet needs that their therapies aim to fulfill.

As SELLAS forges ahead into 2025, the launch of new clinical cohorts and the continuous emphasis on innovative cancer therapeutics reflect the company’s dedication to addressing critical healthcare challenges and enhancing patient outcomes further. The Company looks forward to sharing progress and engaging with stakeholders in upcoming events, propelling the vision of transforming cancer care.

Frequently Asked Questions

What is SELLAS Life Sciences focused on for 2025?

SELLAS aims to advance its clinical stage portfolio, particularly focusing on SLS009 and Galinpepimut-S for various cancer indications.

What are the key milestones expected in 2025?

The Company expects crucial developments in clinical data, regulatory feedback, and continued progress in pediatric programs.

How does SELLAS plan to approach pediatric treatments?

SELLAS is seeking grant funding to expand SLS009's development into pediatric AML and potentially other malignancies.

What recent designations has SELLAS received?

SELLAS has received multiple regulatory designations, including the FDA Rare Pediatric Disease Designation for its therapies.

How can stakeholders learn more about SELLAS's progress?

SELLAS invites stakeholders to their corporate webinars and provides updates through their official channels.

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