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SELLAS Life Sciences (SLS) Is Up 15.5% After Encouraging Phase 2 Data In High-Risk AML

Simply Wall St·12/12/2025 04:42:07
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  • SELLAS Life Sciences Group recently reported Phase 2 data showing that its CDK9 inhibitor SLS009, combined with azacitidine and venetoclax, achieved a 46% overall response rate and extended median survival in heavily pretreated relapsed or refractory AML-MR patients, with no dose-limiting toxicities or treatment-related deaths observed.
  • An especially important finding was the strong activity in patients with high-risk ASXL1 and TP53 mutations and in those with only one prior line of therapy, where response rates were higher and median overall survival had not yet been reached.
  • Next, we’ll examine how this evidence of clinically meaningful activity in venetoclax-exposed AML-MR patients could reshape SELLAS’ investment narrative.

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What Is SELLAS Life Sciences Group's Investment Narrative?

To own SELLAS Life Sciences, you have to believe that its high‑risk, high‑reward oncology pipeline can convert promising data into approved products before capital runs thin. The latest SLS009 Phase 2 update slots directly into that thesis: a 46% response rate and encouraging survival in venetoclax‑exposed AML‑MR patients support management’s plan to move into frontline high‑risk AML in 2026 and deepen the company’s presence in a difficult disease setting. In the near term, the main clinical catalyst remains the REGAL Phase 3 readout for GPS in AML CR2 by year‑end, now complemented rather than replaced by SLS009’s momentum. At the same time, the stock’s strong 1‑year run, zero revenue and ongoing losses keep funding needs, dilution risk and trial failure risk firmly in focus.

However, one funding and dilution risk stands out that investors should not ignore. Upon reviewing our latest valuation report, SELLAS Life Sciences Group's share price might be too optimistic.

Exploring Other Perspectives

SLS 1-Year Stock Price Chart
SLS 1-Year Stock Price Chart
Four Simply Wall St Community valuations span US$4 to US$40 per share, reflecting sharply different expectations. When you set that against binary trial risks and recent price volatility, it reinforces why checking multiple viewpoints on SELLAS’ outlook really matters.

Explore 4 other fair value estimates on SELLAS Life Sciences Group - why the stock might be worth just $4.00!

Build Your Own SELLAS Life Sciences Group Narrative

Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.