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SELLAS Provides Corporate Updates and Highlights Key Upcoming Milestones

– Company to Host Corporate Update Webinar Today, January 3, 2024, at 8:30 am ET-

-Interim Analysis of Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia Expected in First Quarter 2024 –

– Phase 2a Study of SLS009 in Relapsed/Refractory AML Patients Ongoing with Topline Data Expected in First Quarter of 2024

– Phase 1b/2 Study in Relapsed/Refractory Peripheral T-cell Lymphoma Patients Ongoing with Top-line Data Expected in First Half 2024 –

NEW YORK, Jan. 03, 2024 (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 provided a business update and will host a corporate webinar at 8:30 am ET.

“2023 was a very productive year for SELLAS,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We advanced our clinical-stage programs for both galinpepimut-S (GPS) and SLS009, reported positive initial topline Phase 2a data of SLS009 which showed the first complete response achieved in an acute myeloid leukemia (AML) patient resistant to venetoclax combination therapies and significant antileukemic effect and apparent survival benefit, initiated a Phase 1b/2 trial of SLS009 in relapsed/refractory (r/r) peripheral T-cell lymphomas (PTCL) and held a successful FDA Type C meeting which solidified our GPS CMC program and commercial manufacturing and regulatory plans. We are pleased that the potential for SLS009 has been recognized by the FDA as evidenced by the granting of Fast Track Designation for PTCL and Orphan Drug Designations for AML and PTCL.”

Dr. Stergiou continued: “We hope to build on this excellent progress and look forward to multiple clinical milestones that have the potential to create significant value for our shareholders. These include reporting interim data from the Phase 3 REGAL trial of GPS in AML as well as topline data from our Phase 2a SLS009 r/r AML trial this quarter and topline data from the Phase 1b/2 study of SLS009 in PTCL by the end of the second quarter. We believe that 2024 will be a pivotal year for SELLAS as we continue to advance our clinical-stage GPS and SLS009 programs that address a broad spectrum of hematologic malignancies and solid tumor indications. We welcome you to join us on our 8:30am call this morning where we will discuss further relevant corporate matters.”

2024 Milestones:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

SLS009: highly selective CDK9 inhibitor

2023 Highlights:

Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic

SLS009: highly selective CDK9 inhibitor

Webinar:  
Date: Wednesday, January 3, 2024
Time: 8:30 a.m. Eastern Time
Dial-in (U.S.): 1-877-423-9813
International Dial-in: 1-201-689-8573
Webcast: SELLAS Update Call
   

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 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 (formerly GFH009), a small molecule, highly selective CDK9 inhibitor, which is licensed from GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and diagnostic uses in the world outside of Greater China.

For more information on SELLAS, please visit www.sellaslifesciences.com.

Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and is not a trademark of SELLAS. Opdivo® is a registered trademark of Bristol-Myers Squibb Company, New York, NY, USA and is not a trademark of SELLAS. The manufacturers of these brands are not affiliated with and do not endorse SELLAS or its products.

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 and SLS009 clinical development programs, including data therefrom, regulatory strategy and expected milestones. 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 16, 2023 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

Bruce Mackle

Managing Director

LifeSci Advisors, LLC

SELLAS@lifesciadvisors.com


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