8-K: SELLAS Life Sciences Announces Positive Clinical Trial Results and First Quarter 2025 Financials

SELLAS Life Sciences reports positive survival data from its SLS009 trial in AML, promising preclinical results, and a cash position of $28.4 million as of March 31, 2025.

Summary

• SELLAS Life Sciences Group reported its first quarter 2025 financial results and provided a corporate update.
• Positive overall survival data was announced from the Phase 2 trial of SLS009 in relapsed/refractory Acute Myeloid Leukemia (AML).
• Patients with AML-Myelodysplasia-Related Changes (AML-MRC) achieved a median overall survival (mOS) of 8.9 months.
• Patients relapsed or refractory to venetoclax-based regimens achieved a mOS of 8.8 months, surpassing the historical benchmark of 2.5 months.
• SLS009 also demonstrated a 67% Overall Response Rate (ORR) in patients with AML-MRC and 46% in all evaluable patients, exceeding the targeted 20% ORR.
• Preclinical data highlighted the efficacy of SLS009 in TP53 mutated AML, reducing TP53-mutated leukemia cell populations by up to 97% in combination with azacitidinevenetoclax.
• The final analysis of the Phase 3 REGAL trial of Galinpepimut-S (GPS) in AML is anticipated in 2025.
• SELLAS had $28.4 million in cash and cash equivalents as of March 31, 2025, with an additional $4.0 million received in April 2025 through warrant exercises.
• Research and development expenses for the quarter were $3.2 million, compared to $5.1 million for the same period in 2024.
• General and administrative expenses for the first quarter of 2025 were $2.9 million, compared to $4.5 million for the same period in 2024.
• The net loss for the first quarter of 2025 was $5.8 million, or a basic and diluted loss per share of $0.07, compared to a net loss of $9.6 million for the first quarter of 2024, or a basic and diluted loss per share of $0.21.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results, promising preclinical data, and a strong cash position, indicating a positive outlook for the company. However, the net loss and inherent risks associated with drug development temper the overall sentiment.

Positives

• Positive overall survival data from the Phase 2 trial of SLS009 in r/r AML, with mOS exceeding historical benchmarks.
• Promising preclinical data highlighting the 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.
• Promising data from Phase 2a Trial of SLS009 in combination with Zanubrutinib in DLBCL, showing a high overall response rate.
• Preliminary data for Pediatric Acute Lymphoblastic Leukemia (ALL) Patients Derived Xenografts (PDX) showing tripled median survival in the SLS009 arm.
• Strong cash position of $28.4 million as of March 31, 2025, with an additional $4.0 million received in April 2025.
• Decrease in research and development expenses and general and administrative expenses compared to the same period in 2024.
• Reduced net loss for the first quarter of 2025 compared to the first quarter of 2024.

Negatives

• The company reported a net loss of $5.8 million for the first quarter of 2025.
• The company is still in the clinical stage, meaning there are no products generating revenue.

Risks

• The forward-looking statements are subject to risks and uncertainties, including those related to oncology product development, clinical success, and regulatory approval.
• The company's actual results and the timing of events could differ materially from those anticipated in forward-looking statements.
• The company's Annual Report on Form 10-K filed on March 20, 2025, and other SEC filings outline additional risks and uncertainties affecting SELLAS and its development programs.

Future Outlook

SELLAS anticipates full topline Phase 2 data of SLS009 soon and the final analysis of the Phase 3 pivotal REGAL trial of GPS in AML later this year.

Management Comments

• We are very encouraged by the strong momentum across our pipeline, said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
• The positive overall survival data in cohort 3 from the ongoing Phase 2 trial of SLS009 in r/r AML, showing a median OS that exceeds all historical benchmarks by over 3 times, further underscores the transformative potential of SLS009 for many underserved patients.
• We look forward to presenting further data on SLS009 at ASCO, highlighting its preclinical efficacy in ASXL1-mutated colorectal cancer lines.
• With the full topline Phase 2 data of SLS009 anticipated soon, and the final analysis of our Phase 3 pivotal REGAL trial of GPS in AML expected later this year, we are well-positioned for an exciting and meaningful 2025.

Industry Context

SELLAS is focused on developing novel therapies for a broad range of cancer indications, specifically targeting the WT1 protein and CDK9 inhibition. The company's lead product candidate, GPS, and SLS009 (tambiciclib) aim to address unmet needs in hematologic malignancies and solid tumor indications.

Comparison to Industry Standards

• The median overall survival (mOS) of 8.9 months in AML-MRC patients treated with SLS009 surpasses the historical benchmark of 2.5 months, suggesting a significant improvement over existing treatments.
• The interim analysis of the REGAL trial indicates a median survival of over 13.5 months, compared to a historical median survival of 6 months for conventional therapy in a similar Phase 2 study.
• The 67% overall response rate (ORR) in the Phase 2a trial of SLS009 in combination with Zanubrutinib in DLBCL is more than double the expected ORR of zanubrutinib alone, indicating a potential synergistic effect.
• These results position SELLAS as a potential leader in the development of novel cancer therapies, particularly in AML and DLBCL.

Stakeholder Impact

• Positive clinical trial results and a strong cash position could increase shareholder value.
• Advancement of novel cancer therapies could improve patient outcomes.
• Continued development of GPS and SLS009 could create new job opportunities.
• Successful completion of clinical trials and regulatory approval could lead to increased revenue and profitability.

Next Steps

• Present further data on SLS009 at ASCO 2025.
• Await full topline Phase 2 data of SLS009.
• Conduct final analysis of the Phase 3 pivotal REGAL trial of GPS in AML.
• Determine the next steps in development around lymphoma by GenFleet Therapeutics.

Key Dates

Keywords

SELLAS Life Sciences, SLS009, Galinpepimut-S, GPS, AML, Acute Myeloid Leukemia, Clinical Trial, Financial Results, Oncology, Biopharmaceutical