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SELLAS Life Sciences to Present Preclinical Data Highlighting Potent Activity of SLS009 in AML at the 2026 AACR Conference

MWN-AI** Summary

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, has announced its intention to present compelling preclinical data on its investigational drug SLS009 (tambiciclib) during the upcoming American Association for Cancer Research (AACR) conference. Scheduled to take place from April 17-22, 2026, at the San Diego Convention Center, SELLAS will showcase the significant potential of SLS009, a selective CDK9 inhibitor, particularly in targeting acute myeloid leukemia (AML).

The presented research highlights that exposure to varying concentrations of SLS009 led to increased levels of active caspase-3 and reduced MCL-1 expression across AML cell lines. Significantly, the drug demonstrated enhanced potency, with the IC50 falling from 50 nM to around 20 nM with repeated administration, indicating a strong apoptotic effect. Observations of these effects were noted as early as six hours post-treatment, continuing to escalate at the 24-hour mark.

Dr. Philip Amrein, the lead investigator from Mass General Brigham Cancer Institute, emphasized the promise of tambiciclib's optimized dosing schedules at clinically relevant concentrations. Noteworthy is SLS009's efficacy against AML models with ASXL1 and TP53 mutations, which typically signify poor clinical outcomes and treatment resistance. Dr. Dragan Cicic, SELLAS’ Chief Development Officer, remarked on the compound’s ability to target critical AML cell survival pathways, enhancing its potential effectiveness in combination therapy regimens.

The findings will be elaborated upon in a poster session titled "Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines," scheduled for April 21, 2026. This revelation underscores SELLAS’s commitment to advancing innovative oncology treatments that could provide significant benefits for patients grappling with challenging cancer indications.

MWN-AI** Analysis

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently made headlines by announcing the upcoming presentation of preclinical data for its lead compound SLS009 at the 2026 American Association for Cancer Research (AACR) conference. The drug, a selective CDK9 inhibitor, has shown promising results in preclinical studies targeting acute myeloid leukemia (AML). Notably, data indicates that SLS009 can significantly enhance apoptosis in AML cells, even those resistant to conventional therapies due to specific mutations like ASXL1 and TP53.

The results highlighting SLS009's mechanism—lowering MCL-1 and survivin levels while elevating active caspase-3—suggest it effectively diverts AML cells from survival pathways. The increasing potency demonstrated with repeated exposure (IC50 dropping from 50 nM to 20 nM) is crucial for leveraging effective dosing schedules in a clinical setting.

From an investment outlook, SELLAS presents an intriguing opportunity. The potential for SLS009 to emerge as a best-in-class molecule sets it apart in a competitive field. Positive data showcased at the AACR can act as a catalyst for the stock, as it strengthens the case for advancing clinical trials and attracting partnerships. Furthermore, if the data translates well into clinical efficacy, SELLAS could significantly impact patient outcomes in high-risk AML subtypes, broadening its market appeal.

However, investors should remain cautious about inherent industry risks, including regulatory hurdles and the broader oncology market volatility. Comprehensive risk assessments must be conducted, particularly with the company’s reliance on clinical success and market adoption.

In summary, for those willing to navigate the uncertainties of biotech investment, SELLAS presents a potentially lucrative buy opportunity, bolstered by promising preclinical data and an innovative therapeutic approach in AML. Close attention to the company’s upcoming presentations at the AACR and subsequent market response would be advisable.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: GlobeNewswire

NEW YORK, March 17, 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 preclinical data on SLS009 (tambiciclib), a potent, selective CDK9 inhibitor, will be presented in a poster session at the American Association for Cancer Research (AACR) taking place April 17-22 at San Diego Convention Center in San Diego, CA. The abstracts will be published in the online Proceedings of the AACR.

Exposure of acute myeloid leukemia (AML) cell lines to increasing concentrations of SLS009 for 6 hours resulted in increased active caspase-3 levels and decreased MCL-1 expression. When cells were treated repeatedly for 8 hours up to 3 doses, the IC50 decreased from 50 nM to about 20 nM, demonstrating enhanced potency with repeated exposure. Changes in caspase-3 and MCL-1 were observed as early as 6 hours after completion of treatment and became more pronounced at 24 hours. Lower levels of MCL-1 and survivin were strongly correlated with increased apoptosis.

“These new data show tambiciclib’s promise in using optimized, clinically actionable schedules at patient-relevant concentrations,” said Dr. Philip Amrein, clinician investigator at Mass General Brigham Cancer Institute and Assistant Professor of Medicine, Harvard Medical School, who designed and conducted experiments.

Notably, SLS009 demonstrated activity even in AML models harboring ASXL1 and TP53 mutations, which are typically associated with high resistance and poor clinical outcomes.

“These data demonstrate that SLS009 effectively targets AML cell survival mechanisms and induces apoptosis across diverse molecular subtypes, including high-risk genetic backgrounds,” said Dr. Dragan Cicic, Senior Vice President and Chief Development Officer of SELLAS. “The ability to lower apoptotic threshold in AML cells by suppressing key survival pathways and enhancing potency with repeated exposure further supports the development of SLS009, including in combination regimens. We look forward to sharing the findings at this year’s AACR conference.”

Poster presentation details:

Title: Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines

Session Title: Cell Death Pathways and Treatment

Session Date and Time: 4/21/2026 2:00:00 PM

Location: Poster Section 11

Abstract Presentation Number: 5666

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
jfraunces@lifesciadvisors.com


FAQ**

How does SELLAS Life Sciences Group Inc. SLS plan to optimize the administration of SLS009 in clinical settings based on the preclinical data presented at the AACR conference?

SELLAS Life Sciences Group Inc. plans to optimize the administration of SLS009 in clinical settings by leveraging insights from preclinical data presented at the AACR conference to enhance dosing schedules and patient selection for improved efficacy and safety outcomes.

What are the implications of SLS009's demonstrated efficacy in AML models with ASXL1 and TP53 mutations for the future development strategies of SELLAS Life Sciences Group Inc. SLS?

The demonstrated efficacy of SLS009 in AML models with ASXL1 and TP53 mutations suggests potential for targeted therapeutic strategies, enhancing SELLAS Life Sciences Group Inc.'s development pipeline and positioning it favorably for future clinical trials and market opportunities.

Can you elaborate on the combination regimens that SELLAS Life Sciences Group Inc. SLS is considering in conjunction with SLS009, particularly for addressing AML?

SELLAS Life Sciences Group Inc. is exploring combination regimens for SLS009 in addressing AML, focusing on partnerships with immune checkpoint inhibitors and other targeted therapies to enhance efficacy and improve patient outcomes in this challenging cancer.

What key milestones does SELLAS Life Sciences Group Inc. SLS anticipate for SLS009 in the coming months or years, following the upcoming presentation at the AACR?

SELLAS Life Sciences Group Inc. anticipates key milestones for SLS009, including data updates from ongoing clinical trials, potential regulatory filings, and further collaborations, following its presentation at the AACR.

**MWN-AI FAQ is based on asking OpenAI questions about SELLAS Life Sciences Group Inc. (NASDAQ: SLS).

SELLAS Life Sciences Group Inc.

NASDAQ: SLS

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