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SELLAS Life Sciences Group to Host Virtual R&D Day on October 29, 2025: Advancing Novel Therapies in Acute Myeloid Leukemia (AML): An Overview of the Ongoing Phase 3 REGAL Trial of Galinpepimut-S (GPS) and SLS009 Program Update

MWN-AI** Summary

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, is set to host a virtual R&D Day on October 29, 2025, at 10:00 AM ET. The event will address the pressing unmet medical needs in acute myeloid leukemia (AML) and the evolving treatment landscape. Key opinion leaders and company management will discuss the ongoing Phase 3 REGAL trial of SELLAS' lead product candidate, Galinpepimut-S (GPS), with results expected by year-end 2025. This trial specifically focuses on patients in complete second remission (CR2).

During the R&D Day, SELLAS will also provide updates on its second program, SLS009, a selective cyclin-dependent kinase 9 (CDK9) inhibitor. Recent Phase 2 data will be shared, along with plans for a new study targeting newly diagnosed and frontline AML patients anticipated to commence in Q1 2026.

Prominent figures in the AML research community, including Dr. Omer Jamy from the University of Alabama, Dr. Panagiotis Tsirigotis from the National and Kapodistrian University of Athens, Dr. Philip Amrein from Harvard Medical School, and Dr. Sharif Khan from Bon Secours Health System, will participate as speakers. Each of these experts brings extensive experience in AML treatment and clinical research, with Dr. Jamy and Dr. Tsirigotis being key investigators in the REGAL trial.

SELLAS Life Sciences aims to innovate hematological and solid tumor therapies through GPS, which targets the WT1 protein present in various cancers, and SLS009, which has shown promise in patients with specific unfavorable prognostic factors. For further details about the company and the R&D event, visit [SELLAS Life Sciences website](http://www.sellaslifesciences.com).

MWN-AI** Analysis

SELLAS Life Sciences Group (NASDAQ: SLS) is gaining attention as it prepares for a virtual R&D Day on October 29, 2025, focusing on its advancing therapies in acute myeloid leukemia (AML). With significant initiatives, including the ongoing Phase 3 REGAL trial for its lead candidate, Galinpepimut-S (GPS), and promising developments for SLS009, this event will be crucial for potential investors.

The REGAL trial is crucial to evaluating GPS's efficacy in patients with AML. Results are expected by year-end, which may serve as a pivotal moment for SELLAS. Historically, the results of late-stage clinical trials can result in considerable price movements for biopharmaceutical stocks; the implications of positive results could bolster investor confidence, while adverse outcomes might lead to declines.

Moreover, the recent Phase 2 data on SLS009, a selective CDK9 inhibitor, opens an intriguing avenue for further growth. With anticipated trials targeting newly diagnosed AML patients set to commence in 2026, SELLAS appears to be positioning itself at the forefront of AML treatment innovation. Given tenacious unmet medical needs in this space, SLS009's targeted approach has the potential to differentiate itself among competing therapies.

Despite these positives, it's essential to consider the inherent risks associated with clinical trials. Biotech stocks are often volatile and can experience significant fluctuations based on trial results and regulatory approvals. Investors should closely follow updates from the R&D Day, particularly insights from key opinion leaders and trial investigators, as these can provide valuable context for the efficacy of new therapies.

In summary, SELLAS presents a compelling opportunity in the oncology landscape, contingent on upcoming trial results and continued progression through its pipeline. Careful monitoring and a strategic approach could yield fruitful outcomes for investors looking to capitalize on advancements in AML treatment.

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

Source: GlobeNewswire

NEW YORK, Sept. 30, 2025 (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 will host a virtual R&D Day on Wednesday, October 29, 2025 at 10:00 AM ET featuring key opinion leaders (KOLs), alongside company management, to discuss the unmet medical need and evolving treatment landscape for acute myeloid leukemia (AML). To register, click here.

The event will feature an overview of the ongoing Phase 3 REGAL trial of GPS (results expected by year-end) and a discussion of the unmet needs of AML patients in complete second remission (CR2). SELLAS will also present an update of SLS009, its highly selective cyclin-dependent kinase 9 (CDK9) inhibitor, highlighting recently reported Phase 2 data and plans for a newly diagnosed and frontline AML study anticipated to begin in the first quarter of 2026.

A live Q&A session will follow the formal presentations.

About Omer Jamy, MD
Omer Jamy, MD is Assistant Professor of Medicine at the University of Alabama (UAB) in the Division of Hematology and Oncology and Associate Scientist, Experimental Therapeutics at the O'Neal Comprehensive Cancer Center. He serves as principal investigator of the Phase 3 REGAL study at UAB, one of the trial’s highest enrolling sites, and leads several clinical trials in addition to REGAL, focusing on AML, chronic myelogenous leukemia, and allogeneic stem cell transplantation. Dr. Jamy completed his internal medicine residency at the University of Tennessee in Memphis followed by fellowship training at UAB in hematology/oncology, bone marrow transplantation and cellular therapy.

About Panagiotis Tsirigotis, MD, PhD
Panagiotis Tsirigotis, MD, PhD is Professor of Hematology at the National and Kapodistrian University of Athens, School of Medicine in Athens, Greece, and Scientific Director of the Transplantation Program of the Hematology Unit since 2010. He is an investigator in the Phase 3 REGAL trial and has enrolled the highest number of patients in the study. His clinical work focuses on AML with particular emphasis on cellular therapies and hematopoietic cell transplantation. Dr. Tsirigotis' research focuses on the application of immunotherapy methods to prevent leukemia relapse after allogeneic transplantation, such as the administration of donor lymphocytes, as well as on mechanisms of immune escape in hematologic malignancies. He is the president of Acute Leukemia Working Party of the Hellenic Society of Hematology, and Vice President of the Hellenic Transplant Organization.

About Philip Amrein, MD
Philip Amrein, MD is Assistant Professor of Medicine at Harvard Medical School and a physician at the Massachusetts General Hospital (MGH), where he is part of the Cancer Center, Leukemia, Cellular Immunotherapy, and Hematology/Oncology departments. Dr. Amrein specializes in treating adults with acute and chronic leukemias, myelodysplasia, and myeloproliferative neoplasms, and leads numerous clinical trials exploring novel treatment approaches. Dr. Amrein has conducted research with SLS009 and is an expert in cyclin-dependent kinases (CDK).

About Sharif Khan, MD
Sharif Khan, MD is a hematologist at Bon Secours Health System in Greenville, SC. He is a highly rated specialist in indications such as AML, myeloproliferative neoplasms, multiple myeloma, non-Hodgkin lymphoma, and bone marrow transplantation. In addition to clinical care, Dr. Khan is a researcher for cutting-edge, breakthrough therapies and started a CAR T-Cell program at Bon Secours Health System. Dr. Khan serves as an investigator in both the REGAL trial of GPS and the SLS009 clinical program.

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 our ability to close the offering, the gross proceeds from the offering and the expected use of proceeds. 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**

What are the key outcomes expected from the ongoing Phase 3 REGAL trial of GPS, and how might these results impact the future positioning of SELLAS Life Sciences Group Inc. SLS in the AML treatment landscape?

The Phase 3 REGAL trial of GPS is expected to yield crucial efficacy and safety results that could position SELLAS Life Sciences Group Inc. SLS as a competitive player in the AML treatment landscape, potentially enhancing its marketability and partnership opportunities.

How does the recently reported Phase 2 data for SLS009 enhance SELLAS Life Sciences Group Inc. SLS's strategy for targeting AML, particularly in patients with adverse prognostic factors?

The Phase 2 data for SLS009 strengthens SELLAS Life Sciences' strategy for targeting AML by demonstrating its potential effectiveness in patients with adverse prognostic factors, thereby enhancing the treatment options available for this challenging patient population.

Can you elaborate on the anticipated timeline for the newly diagnosed and frontline AML study involving SLS009, and how it aligns with SELLAS Life Sciences Group Inc. SLS's broader development goals?

The anticipated timeline for the new frontline AML study involving SLS009 is projected to align with SELLAS Life Sciences Group Inc.'s broader development goals by advancing patient enrollment and data collection in the coming quarters, ultimately aiming for regulatory submissions by mid-2024.

What differentiates SLS009 from other CDK9 inhibitors in the market, and how does SELLAS Life Sciences Group Inc. SLS plan to leverage this advantage in its clinical development and commercialization efforts?

SLS009 differentiates itself by its selective targeting of CDK9 with potentially fewer side effects, and SELLAS Life Sciences plans to leverage this advantage through focused clinical trials and strategic partnerships to enhance its market position and commercialization efforts.

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

SELLAS Life Sciences Group Inc.

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