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NEW YORK, Jan. 02, 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 corporate update call on Wednesday, January 8, 2025, at 9:00 a.m. Eastern Time. Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, will discuss the Company’s outlook for...

- Study Reaches Pre-Specified Threshold of 60 Events (Deaths) Initiating the Interim Analysis – - REGAL Independent Data Monitoring Committee to Perform Interim Analysis in January 2025 - - Company to Host Webcast Call Today at 9:00 am ET NEW YORK, Dec. 10, 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...

- Median Overall Survival (mOS) Not Yet Reached, Now Exceeds 7.7. Months at Latest Follow-Up in the 30 mg BIW Cohort in Patients Relapsed or Refractory to Venetoclax-Based Regimens - - Overall Response Rate (ORR) of 56% Achieved to Date in Patient with Acute Myeloid Leukemia with Myelodysplasia Related Changes (AML MRC) Prospectively Enrolled in Two Expansion Cohorts; Exceeding Prespecified Target Response Rate of 33% - NEW YORK, Dec. 09, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc....

- Preselection Method for Cancers Responding to SLS009: High Efficacy of SLS009 Observed in 67% of ASXL1 Mutated Solid Cancers vs 0% in Non-ASXL1 Mutated Cancers – - ASXL1 Mutations Predictably Identified in Colorectal Cancer (CRC MSI-H) and Non-Small Cell Lung Cancer (NSCLC) in Addition to Hematologic Malignancies - - Existing Clinical Data Demonstrating SLS009 Efficacy in ASXL1 mutated AML and Safety Across Multiple Cancer Types Lay Foundation for Targeted SLS009 Clinical Trial in Selected...

– Pre-specified Events to Trigger Interim Analysis of Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Remains on Track for Q4 2024 – – Data from the Phase 2a Trial of SLS009 in Relapsed/Refractory AML After Venetoclax Failure to be Presented at the Upcoming American Society of Hematology (ASH) Annual Meeting in December – – GPS Granted FDA Rare Pediatric Disease Designation (RPDD) for the Treatment of Pediatric AML – NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) --...

- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure – - 50% Response Rate at the Selected Dose Level of 30 mg Twice a Week (BIW) – - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.5 Months vs. <2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg BIW Median OS Not Reached - NEW YORK, Nov. 05, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc....

- GPS Currently Investigated in Phase 3 REGAL Trial in Adult AML Patients – Interim Analysis Anticipated in Q4 2024 - - RPDD Provides Eligibility for GPS to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Recent Valuations for PRVs Remain Attractive (~$100 million/each) – NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical...

NEW YORK, Oct. 10, 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 announced that Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on Tuesday, October 15, 2024 at 9:00 am EDT. Maxim Healthcare...

- Announced Independent Data Monitoring Committee’s (IDMC) Recommendation to Continue the Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Without Modifications: Interim Analysis Anticipated by Q4 2024 - - Reported Positive Preliminary Data from the Phase 2a Trial of SLS009 in r/r AML Demonstrating to Date Overall Response Rate (ORR) of 33%, 50%, and 100% in 60 mg QW, 30 mg BIW and 30mg BIW with ASXL1 Mutation Cohorts Respectively - - SLS009 Granted EMA Orphan Drug...

NEW YORK, Aug. 06, 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 announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) peripheral T-cell lymphomas...

NEW YORK, July 31, 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 announced that it has entered into a securities purchase agreement with a single institutional investor for the purchase and sale of 15,849,056 shares of common stock (or common stock equivalents in lieu thereof) and warrants to...

- Acute Myeloid Leukemia (AML) is the Second Most Common Hematological Malignancy in Children Often Associated with Poorer Prognosis Compared to Other Pediatric Cancers – - This Recognition Marks SELLAS’ Second RPDD Following the Designation for ALL Received Last Month - - Opened Enrollment for Pediatric AML Patients in Ongoing Phase 2 Clinical Trial - - RPDD Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to...

NEW YORK, July 08, 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 announced that the European Commission, based on a positive opinion issued by the European Medicines Agency (EMA), has granted Orphan Drug Designation (ODD) for SLS009, a novel, and highly selective CDK9 inhibitor, for the...

- Acute Lymphoblastic Leukemia (ALL) is the Most Common Type of Cancer in Children – - Rare Pediatric Disease Designation (RPDD) Provides Eligibility for SLS009 to Receive a Priority Review Voucher (PRV) Upon Marketing Approval that can be Transferred/Sold to Other Parties – - Past Sales of PRVs Have Averaged More Than $100 Million - NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical...

– The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications – – No Safety or Futility Concerns Were Raised Based on the Efficacy and Safety Assessment of All REGAL Patients – – Interim Analysis Anticipated by Q4 2024 – NEW YORK, June 17, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development...

- 30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule - - Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively - - 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet - - 100% Overall Response Rate in Patients with ASXL1 Mutation in the 30 mg BIW...

- Announced Independent Data Monitoring Committee’s (IDMC) Recommendation to Continue the Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Without Modifications: IDMC to Reconvene in June - - Completed Enrollment in Phase 3 REGAL Study of Galinpepimut-S - - Announced Positive Phase 2 Data of SLS009 Demonstrating 100% Response Rate in r/r AML Patients with ASXL1 Mutation at 30 mg BIW Dose and 62% Anti-Leukemic Activity Across All Dose Levels; Additional Data Expected in the...

- The Company Filed IP Protection Related to the ASXL1 Mutation, a Highly Prevalent Gene Mutation in Myeloid Malignancies and Solid Tumors With Significant Market Potential – - 100% Overall Response Rate in Patients with ASXL1 Mutation in the SLS009 30mg BIW Cohort to Date, All Patients Alive: Further Support for Potential Accelerated Approval Pathway in Defined Patient Population – - SLS009 Exhibits Strong Anti-Leukemic Activity in 62% of Patients with a Favorable Safety Profile Across All...

– Based on the Efficacy and Safety Data Assessed, the Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Patients Treatment and Follow-Up Without Any Modifications – – IDMC Will Convene Again Ahead of Scheduled IDMC Charter Meeting – – Next Efficacy and Safety Assessment of All REGAL Patients (n=127) in June 2024 – NEW YORK, April 29, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a...

Announced Phase 2a study of SLS009 in r/r AML Showing 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20% and 100% Response Rate in Patients with Identified Biomarkers - Completed Enrollment in Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia; Steering Committee Guided Interim Analysis May Be Imminent; IDMC Scheduled in Late April- Phase 1b/2 Study of SLS009 in Relapsed/Refractory Peripheral T-cell Lymphoma Patients Ongoing with...