SELLAS Life Sciences Enters Agreement with IMPACT-AML to Expand SLS009 Clinical Program into Europe
Rhea-AI Summary
SELLAS Life Sciences (NASDAQ: SLS) entered an agreement with IMPACT-AML to expand the SLS009 clinical program into Europe, leveraging the IMPACT-AML STREAM platform and EU Mission Cancer network.
The collaboration plans U.S. enrollment of SLS009 plus azacitidine and venetoclax (AZA/VEN) in newly diagnosed, high-risk AML in Q1 2026, with European site initiation anticipated in Q2 2026, subject to regulatory and site readiness. The European study is planned to enroll approximately 40 patients. SELLAS describes the arrangement as capital-efficient and intended to broaden and accelerate patient access and enrollment.
Positive
- Access to IMPACT-AML pan-European network for site activation
- Planned U.S. enrollment start in Q1 2026
- Planned European initiation in Q2 2026
- European study planned to enroll approximately 40 patients
- Combination study uses established AZA/VEN backbone with SLS009
Negative
- European start contingent on regulatory and site readiness
- Planned enrollment (~40 patients) is limited in scale
News Market Reaction
On the day this news was published, SLS declined 0.96%, reflecting a mild negative market reaction. Argus tracked a trough of -14.7% from its starting point during tracking. Our momentum scanner triggered 22 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $6M from the company's valuation, bringing the market cap to $628M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
SLS was up 0.97% while peers were mixed: ELTX +0.91%, TNYA +1.2%, TRDA +5.55%, but TLSA -1.46% and CGTX -2.72%, indicating stock-specific dynamics rather than a broad biotech move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 29 | Phase 3 trial update | Neutral | +16.7% | REGAL Phase 3 AML trial neared 80-event OS trigger with 72 events. |
| Dec 07 | Phase 2 data | Positive | +4.6% | SLS009 plus AZA/VEN showed 46% ORR and favorable survival in AML-MR. |
| Nov 12 | Q3 2025 earnings | Neutral | -1.3% | Reported Q3 loss, cash of $44.3M, and outlined AML trial plans. |
| Nov 03 | Data presentation notice | Neutral | -1.6% | Announced upcoming ASH presentation of SLS009 Phase 2 AML data. |
| Oct 27 | Warrant inducement | Negative | -2.5% | Warrant exercises for $31M gross proceeds with new warrants issued. |
Recent SLS news shows strong positive reactions to AML trial progress while financing and neutral updates have produced modest or negative moves, suggesting investors are highly sensitive to clinical milestones.
Over the past few months, SELLAS highlighted multiple AML-focused milestones. A Phase 3 REGAL trial update on Dec 29, 2025 noted 72 of the required 80 overall survival events and drove a 16.72% gain. Positive Phase 2 SLS009 data in relapsed/refractory AML-MR, with a 46% ORR in 35 patients, lifted shares 4.6%. Q3 2025 financials showed a GAAP net loss of $6.8M and cash of $44.3M, supported by warrant-related proceeds. A warrant inducement on Oct 27, 2025 raised about $31.0M. Today’s Europe-focused SLS009 expansion connects directly to this ongoing AML development arc.
Regulatory & Risk Context
An effective Form S-3 shelf filed on 2025-10-10 registers multiple common share blocks, including shares underlying existing warrants, enabling registered resales by holders through various methods. The shelf remains active through 2028-10-10 and has been utilized at least once via a 424B5 filed on 2025-10-27.
Market Pulse Summary
This announcement extends the SLS009 program into frontline high-risk AML, adding a European study of about 40 patients and aligning with prior plans for U.S. enrollment in Q1 2026. It builds on earlier Phase 2 data in relapsed/refractory AML-MR and follows recent financing steps that strengthened cash resources. Investors may watch execution on trial timelines, enrollment across IMPACT-AML sites, and updates on the Phase 3 REGAL GPS study to gauge how this broader AML strategy develops.
Key Terms
acute myeloid leukemia medical
cdk9 inhibitor medical
azacitidine medical
venetoclax medical
AI-generated analysis. Not financial advice.
- Supports capital-efficient expansion of the SLS009 clinical program into frontline AML, enabling broader U.S. and European patient enrollment
- U.S. enrollment evaluating SLS009 in combination with AZA/VEN in newly diagnosed AML with high-risk features is planned for Q1 2026, with European enrollment anticipated in Q2 2026
NEW YORK, Jan. 14, 2026 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it has entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with acute myeloid leukemia (AML). Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients.
IMPACT-AML is a pan-European project and builds an inclusive clinical network (STREAM platform) that connects patients, clinicians, and researchers to test novel AML therapies and improve patient outcomes (https://impactaml.eu/). It is part of the prestigious EU Mission Cancer program and a top-tier scientific cluster. The IMPACT-AML project is led by a consortium of major research and clinical institutions in Europe, including IRST (IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori”), the University of Bologna, IIS LA FE (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organizations under the umbrella of the European Leukemia Net (ELN), as well as various university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a highly cost-efficient manner while supporting broader participation across the clinical program.
“This is a highly meaningful milestone for SELLAS and for the SLS009 program,” said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. “Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects the growing recognition of SLS009’s potential in addressing critical unmet needs in AML. Importantly, this collaboration allows us to efficiently expand our clinical program into Europe by leveraging an established infrastructure, significantly improving capital efficiency while supporting broader and faster patient enrollment as we advance the program into frontline AML.”
The collaboration is expected to support the continued execution of the SLS009 clinical program as SELLAS advances into frontline AML. The study in Europe is planned to enroll approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrollment in the first part of the trial for newly diagnosed patients is expected to begin at U.S. sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory and site readiness.
“IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options,” said IMPACT-AML Scientific Coordinator, Dr. Giovanni Martinelli. “We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, consistent with our mission to facilitate efficient, high-quality clinical research in AML.”
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.
Investor Contact
John Fraunces
Managing Director
LifeSci Advisors, LLC
FAQ
What did SELLAS (SLS) announce about SLS009 and IMPACT-AML on January 14, 2026?
When will SLS009 enrollment begin in the U.S. and Europe for SLS (NASDAQ: SLS)?
How many patients will the European SLS009 study enroll for SLS (SLS)?
What treatment combination will SELLAS test with SLS009 in the frontline AML study?
How does the IMPACT-AML collaboration affect SELLAS's capital efficiency?
