Positive IDMC Recommendation to Continue Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in AML Without Modification; Final Analysis Anticipated by Year-end 2025 Reported Positive Phase 2 Results of SLS009 in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) with Trial Meeting All Primary Endpoints; Full Data Presentation Expected Later This Year Alignment with FDA to Advance SLS009 in a First-Line AML Trial with... Read More

Final Analysis Anticipated by Year-End Upon Occurrence of 80 Events NEW YORK, Aug. 07, 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 the Independent Data Monitoring Committee (IDMC) has completed a pre-specified... Read More

The Trial Exceeded Target Overall Response Rate (ORR) of 20%, with 44% Response Rate Among Patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML MR) Treated at Optimal Dose of 30 mg Twice a Week (BIW) and 50% in AML MR with Myelomonocytic/Myelomonoblastic (M4/M5) Subtype Median Overall Survival (mOS) of 8.9 Months in Patients with AML MR and 8.8 mOS in Relapsed or Refractory to Venetoclax-Based Regimens at... Read More

NEW YORK, July 07, 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 the addition of Linghua Wang, MD, PhD, to its Scientific Advisory Board (SAB). Dr. Wang is a widely respected leader in cancer research and translational... Read More

NEW YORK, June 24, 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 the Company will be added to the Russell 3000 ® and Russell 2000 ® Indexes, effective after the U.S. market close on June 27, as part of the 2025... Read More

New appointments of Drs. Philip C. Amrein and Alex Kentsis Validate Lead Galinpepimut-S and SLS009 Programs as Company Approaches Key Inflection Points This Year NEW YORK, June 05, 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... Read More

ASCO Presentation Supports SLS009 as a Potential Targeted Therapy for ASXL1 Mutated Colorectal Cancer 22,500 New Cases of Colorectal Cancer with High Microsatellite Instability per Year in the US: 55% ASXL1m Frequency NEW YORK, June 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... Read More

NEW YORK, May 20, 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 Dr. Angelos Stergiou, President and Chief Executive Officer of SELLAS, will participate in a fireside chat at the A.G.P. Virtual Healthcare Company... Read More

First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) NEW YORK, May 15, 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... Read More

Announced Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 (tambiciclib) in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) Demonstrating 8.9 mOS in AML-MRC and 8.8 mOS in All r/r to Venetoclax-Based Regimens Patients SLS009 Shows Promising Efficacy in Pediatric Acute Lymphoblastic Leukemia (ALL) Xenograft Models Final Analysis of Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in AML... Read More

NEW YORK, April 28, 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 preclinical efficacy of SLS009 in TP53 mutated Acute Myeloid Leukemia (AML) cells are being presented in a poster session at the American Association... Read More

NEW YORK, April 23, 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 preclinical efficacy of SLS009 in ASXL1 mutated colorectal cancer lines will be presented at the 2025 American Society of Clinical Oncology (ASCO)... Read More

8.9 Months Median Overall Survival (mOS) in Patients with AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 mOS in All Relapsed or Refractory to Venetoclax-Based Regimens Patients; Surpassing Historical Benchmark of 2.5 Months Overall Response Rate (ORR) of 67% Achieved in Patients with AML-MRC (Target Patient Population of SLS009 in r/r AML) – Exceeding Targeted 20% ORR Trial Continues with Full Data and FDA Regulatory... Read More

Announced Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) with Next and Final Analysis Planned Upon Reaching 80 Events, Anticipated in 2025 Reported Positive Overall Survival and Overall Response Rate Data from the Ongoing Phase 2 Trial of SLS009 (Tambiciclib) in r/r AML – Full Data and FDA Regulatory Path Feedback Expected in 1H 2025 Raised $25... Read More

Combination Achieved a 67% of Overall Response Rate, More than Double that of Zanubrutinib Alone; 83% Disease Control Rate in Difficult-to-Treat Non-GCB DLBCL (ABC DLBCL) Patients Median Overall Survival Not Reached Yet – 67% of Patients Still Alive NEW YORK, Feb. 20, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused... Read More

NEW YORK, Jan. 28, 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 has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 19,685,040... Read More

REGAL Successfully Passes Event-Driven (60 Deaths) Interim Analysis for Efficacy, Futility, and Safety: The Independent Data Monitoring Committee (IDMC) Recommended Continuation of the Clinical Trial Without Modification Based on a Review of Unblinded Data, the IDMC Confirmed that GPS Exceeded the Predetermined Futility Criteria, Noted no Safety Concerns and Commended SELLAS for its Operational Excellence and Study Data... Read More

Independent Data Monitoring Committee to Perform Interim Analysis of Phase 3 REGAL Study in January 2025 SLS009: Full Topline Phase 2 Data in Acute Myeloid Leukemia and FDA Regulatory Review Expected in 1H 2025 Approval of “tambiciclib” as Recommended International Nonproprietary Name for SLS009 Applied for Non-Dilutive Grant Funding to Expand SLS009 Development Into Frontline Setting in AML Developing SLS009 Pediatric... Read More

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... Read More

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... Read More

- 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... Read More

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... Read More

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... Read More

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,... Read More

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”... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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,... Read More

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... Read More

Phase 3 REGAL Study of GPS in AML: Enrollment Completed; Steering Committee Guided Interim Analysis Imminent; IDMC Now Scheduled in Late April Phase 2a study of SLS009 in r/r AML: 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20%; 100% Response Rate in Patients with Identified Biomarkers to Date Median OS Has Not Been Reached in the Phase 2a Study of SLS009; First CR Patient Continues on... Read More

NEW YORK, March 19, 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 the closing of its previously announced registered direct offering of 13,029,316 shares of its common stock (or common stock equivalents in lieu thereof)... Read More

Update on the Phase 3 REGAL Clinical Trial of GPS in Acute Myeloid Leukemia (AML) Update on the Phase 2a Clinical Trial of SLS009 in relapsed/refractory AML, including topline data NEW YORK, March 19, 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... Read More

NEW YORK, March 15, 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 definitive agreements with two existing institutional investors for the purchase and sale of 13,029,316 shares of its common stock... Read More

NEW YORK, March 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 it has streamlined its executive leadership to further focus on advancing the Company’s clinical programs while optimizing resource allocation. As... Read More

All key study objectives regarding pharmacokinetic, pharmacodynamic, safety, and clinical activity were met Complete remission (CR) achieved after three months of treatment with duration of eight months and one year survival at the latest assessment First time achievement of CR with CDK9 inhibition monotherapy in relapsed/refractory (r/r) acute myeloid leukemia (AML) patient Phase 2a data in r/r AML patients expected in... Read More

NEW YORK, Feb. 29, 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 date and time for the presentation of data from the acute myeloid leukemia cohort of patients in the Phase 1 dose-escalation study of SLS009... Read More

NEW YORK, Feb. 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 a publication in Oncotarget revealing the underlying mechanisms of action behind the anti-proliferative effects of SLS009 (formerly GFH009), its potent,... Read More

NEW YORK, Jan. 25, 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 data from the acute myeloid leukemia cohort of patients in the Phase 1 dose-escalation study of SLS009 (formerly GFH009) will be presented in an oral... Read More

Phase 2a Enrollment Completed in 45 mg Safety Cohort: Median Overall Survival (OS) Not Reached; 89% of Patients Alive with Significant Antileukemic Effect Observed in 87.5% of Evaluable Patients First Enrolled Patient in Phase 2a Study Achieved Complete Remission and Continues on Study With Full Recovery and in Seventh Month of Survival; Second Enrolled Patient Continues on Study in Sixth Month of Survival; Median OS in... Read More

NEW YORK, Jan. 04, 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 the pricing of its previously announced public offering for the purchase and sale of 12,000,000 shares of common stock (or common stock equivalents in lieu... Read More

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 developing novel therapies for a broad range of cancer indications, today announced that it intends to offer and sell shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase shares of common stock in a... Read More

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... Read More

Primary Endpoint of Safety and Efficacy Met with Clinical Activity and Increased Survival Observed 70.3 Weeks Median Overall Survival for Patients Treated with Combination Therapy; Median Overall Survival in Relapsed/Refractory Patients Treated with Standard of Care is Approximately 28 Weeks Median Overall Survival of Patients without GPS Immune Response was 9.0 Months vs. 27.8 Months for Patients with GPS-Specific Immune... Read More

SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL Patients with Standard of Care is 25.8% One Patient with Complete Metabolic Response Continuing Treatment for over 62 weeks and another patient with Complete Response by CT Continuing Treatment for over 24 weeks - Phase 1b/2 Study in PTCL Ongoing with top line data expected in... Read More

Enrollment Completed in 45 mg Safety Cohort; Safety Monitoring Committee Advocated Proceeding to Recommended Phase 2 Dose Level of 60 mg Patients in 60 mg Dose Cohort Will be Dosed with 60 mg Once per Week or 30 mg Twice per Week Early Data in 45 mg and 60 mg Cohort Expected Around Year-End 2023 NEW YORK, Dec. 14, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a... Read More

NEW YORK, Dec. 13, 2023 (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 webinar on Wednesday, January 3, 2024, at 8:30 a.m. Eastern Time. Angelos Stergiou, MD, ScD h.c., President and Chief... Read More

Independent Data Monitoring Committee (IDMC) Recommended Continuation of Phase 3 REGAL Trial Without Any Modifications IDMC Expressed Satisfaction with Speed of Enrollment and High Study Integrity IDMC Will Review Most Current Survival Data at Next Scheduled IDMC Meeting in Q1 2024 NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical... Read More

NEW YORK, Nov. 29, 2023 (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 target patient enrollment outside of mainland China in the ongoing Phase 3 REGAL trial of galinpepimut-S (GPS) in patients with acute myeloid... Read More

FDA feedback indicates Company’s CMC plans are in alignment with FDA’s requirements and expectations towards a BLA CMC regulatory alignment is critical step in approval pathway for GPS NEW YORK, Nov. 13, 2023 (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... Read More

Phase 3 REGAL Trial of Galinpepimut-S (GPS) on Track to Complete Enrollment ex-China in November 2023 Positive Initial Topline Phase 2a Data of SLS009 Reported with First Complete Response Achieved in Acute Myeloid Leukemia (AML) Patient Resistant to Venetoclax Combination Therapies SLS009 Granted Orphan Drug Designation by U.S. Food & Drug Administration (FDA) for Treatment of AML SLS009 Granted Fast Track Designation by... Read More

Median overall survival for GPS and Keytruda ® combination was 18.4 Months compared to 13.8 Months in a Keytruda ® single agent study (KEYNOTE-028) and 11-14 Months with standard of care chemotherapy Combination of GPS and Keytruda ® yielded WT1-specific T-cell immune response and correlated positively in subset of patients with IFNγ and MIP1β biomarkers: 41% longer progression free survival and statistically significant... Read More

NEW YORK, Oct. 31, 2023 (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, healthcare-focused U.S. institutional investor for the purchase and sale of... Read More

SLS009 Demonstrated Promising Efficacy in Phase 1 Study with 36.4% Clinical Response (ORR) in r/r Peripheral T-cell Lymphomas (PTCL); ORR in r/r PTCL Patients with Standard of Care is 25.8% Fast Track Designation Accelerates SLS009's Path to U.S. FDA Submission for Treatment of r/r PTCL NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage... Read More

NEW YORK, Oct. 17, 2023 (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 topline clinical data from the final analysis of the Phase 1/2 clinical trial of galinpepimut-S (GPS) in combination with pembrolizumab (Keytruda ®... Read More

SLS009 Is First CDK9 Inhibitor in Combination with AZA/VEN to Achieve Complete Response in AML Patient Resistant to Venetoclax Combination Therapies First Patient Enrolled Achieved CR and in Fifth Month of Treatment; Four Patients Continue on Treatment and All Patients Alive Anti-leukemic Effects Observed in All Patients No Significant Safety Issues Observed NEW YORK, Oct. 16, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences... Read More

Enrollment ex-China Expected to be Completed in November 2023 Enrollment in China Expected to Commence this Quarter NEW YORK, Oct. 12, 2023 (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 an update on its Phase 3 open-label... Read More

NEW YORK, Oct. 11, 2023 (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 its partner GenFleet Therapeutics (Shanghai), Inc. has dosed the first patient in a Phase Ib/II trial evaluating SLS009 (GFH009) in relapsed/refractory... Read More

NEW YORK, Oct. 10, 2023 (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 U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, a novel and highly selective CDK9 inhibitor, for the... Read More

52 Relapsed and Refractory Lymphoma Patients Enrolled: 96% Alive at Last Assessment Indicating Favorable Survival Benefit Responses Observed Across Dose Levels with a 14.7% Clinical Response Rate Overall, 35.3% Overall Disease Control Rate, and 36.4% Clinical Response Rate in PTCL Patients Decrease in MCL1 and/or MYC Biomarkers Observed in 100% of Patients in a Dose-Dependent Manner in Once Per Week Administration Regimen... Read More

NEW YORK, Sept. 18, 2023 (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 Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, and members of the SELLAS management team will participate in a panel... Read More

REGAL Interim Analysis Expected by Late 2023/Early 2024 Enrollment Expected to be Completed in Q4 2023 NEW YORK, Aug. 22, 2023 (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 a positive review of the ongoing Phase 3 REGAL... Read More

First Patients Dosed in Phase 2a Clinical Trial of SLS009 (formerly GFH009) in Acute Myeloid Leukemia with Topline Data Expected in 4Q 2023 Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia on Track for Interim Analysis by Late 2023/Early 2024 REGAL Independent Data Monitoring Committee to Meet in 3Q 2023 NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS)... Read More

Primary Endpoint of Safety and Efficacy Endpoint Both Met with Clinical Activity and Increased Survival Observed 70.3 Weeks Median Overall Survival for Patients Treated with Combination Therapy with 40% of Patients Alive as of Last Follow-Up; Median Overall Survival in Relapsed/Refractory Patients Treated with Standard of Care is Approximately 28 Weeks 30% Disease Control Rate per RECIST Criteria No Dose Limiting Toxicities... Read More

NEW YORK, June 22, 2023 (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 first patient has been dosed in a Phase 2a study of its novel and highly selective CDK9 inhibitor, GFH009, in combination with venetoclax and... Read More

NEW YORK, June 15, 2023 (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 acceptance of an abstract for a poster presentation at the Annual Global Meeting of the International Gynecologic Cancer Society (IGCS 2023) which will be... Read More

NEW YORK, June 13, 2023 (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 Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS, has been invited to participate in a fireside chat at the Maxim Group... Read More

NEW YORK, May 25, 2023 (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 a trial in progress poster for the Phase 3 REGAL study of galinpepimut-S (GPS) in acute myeloid leukemia (AML) will be presented at the American Society... Read More

NEW YORK, May 16, 2023 (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 it will host a virtual panel discussion on Tuesday, May 30, 2023 at 8:00 a.m. EST. The panel will feature hematology-oncology specialists Tapan Kadia, MD... Read More

Phase 1 Study of Novel, Highly Selective CDK9 Inhibitor GFH009 Successfully Completed for Patients with Acute Myeloid Leukemia; 94% of Patients Enrolled to Date Alive and Durable Remission in Patient with Acute Myeloid Leukemia > 6 months Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia on Track for Interim Analysis by Late 2023/Early 2024 NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- SELLAS Life... Read More

72 Acute Myeloid Leukemia and Lymphoma High-Risk Advanced Patients Enrolled: 94% Alive at Last Assessment Indicating Favorable Survival Benefit Long-Term Complete Remission and Significant Bone Marrow Blast Reductions in Acute Myeloid Leukemia: Durable Complete Remission with No Minimal Residual Disease Continues > 6 Months vs. Historic Median Survival of 2.5 Months in AML Patient; 77% Bone Marrow Blast Elimination in... Read More

NEW YORK, April 26, 2023 (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 acceptance of an abstract for a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in... Read More

GFH009 showed strong anti-tumor effect and clinical and biological efficacy; PK profile supports anticipated once weekly dosing GFH009 demonstrated a favorable tolerability profile with no dose limiting toxicities SELLAS plans to commence Phase 2a trial with GFH009 in combination with venetoclax and azacitidine in patients with AML during 2Q 2023 with topline data expected in Q4 2023 NEW YORK, April 20, 2023 (GLOBE NEWSWIRE)... Read More

Next IDMC Meeting Scheduled for Q3 2023 REGAL on Track for Interim Analysis by Late 2023/Early 2024 NEW YORK, April 18, 2023 (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 a positive review of the ongoing Phase 3 REGAL clinical... Read More

Phase 3 REGAL GPS AML Study on Track for Interim Analysis by Late 2023/Early 2024 Ongoing Phase 1 Study of CDK9 Inhibitor Suggests Broad Therapeutic Window and High Potential for Both Monotherapy and Combination Treatment $20 Million of Gross Proceeds from Capital Raise in February 2023 Adds to Cash Position of $17.1 Million as of December 31, 2022; Additional $13 Million Milestone Payment Expected in 1H 2023 NEW YORK, March... Read More

Safety and Immunogenicity Examined in Phase 1 Trial of GPS plus Anti–PD-1 Nivolumab in Patients with WT1-Expressing Relapsed Ovarian Cancer in the Post-Salvage Setting Immune Response Translated into Clear Clinical Benefit with 70% One-Year Progression-Free Survival Demonstrated in GPS-Treated Patients NEW YORK, March 07, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”)... Read More

NEW YORK, Feb. 24, 2023 (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 the pricing of its previously announced underwritten public offering of 7,220,217 shares of its common stock and accompanying warrants to purchase up to... Read More

NEW YORK, Feb. 23, 2023 (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 commenced an underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock. All of the... Read More

Event will Feature Presentation from Hematology Oncology Expert Omer Jamy, MD, Phase 3 REGAL Study Principal Investigator at the University of Alabama Participating Site Webcast to be held on Tuesday, January 31, 2023, at 8:30 a.m. EST NEW YORK, Jan. 19, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the... Read More

NEW YORK, Jan. 05, 2023 (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 the appointment of Andrew Elnatan as Vice President, Head of Regulatory Affairs, Chemistry, Manufacturing, and Controls (CMC) and Quality. He joins the... Read More

GFH009 is First CDK9 Inhibitor Monotherapy to Achieve Compete Response in Acute Myeloid Leukemia Anticancer Effects Observed Across Multiple Dose Levels in Both Acute Myeloid Leukemia and Lymphoma Patients No Dose Limiting Toxicities Observed at Any Dose Level to Date Biomarkers of CDK9 Activity Decreased in 97.6% of Patients NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS"... Read More

NEW YORK, Dec. 08, 2022 (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 Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL study for galinpepimut-S (GPS) in acute myeloid leukemia (AML) performed its... Read More

GFH009 exhibits robust activity against small cell lung cancer xenografts, both as monotherapy and in combination with PARP inhibitor olaparib Results support designating small cell lung cancer as first indication in planned solid cancer basket trial for GFH009 NEW YORK, Dec. 01, 2022 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical... Read More

NEW YORK, Nov. 30, 2022 (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 Company will present at the JMP Securities Hematology and Oncology Summit, a virtual investor conference being held from December 6-7, 2022. Angelos... Read More