SELLAS Life Sciences Group

SELLAS Life Sciences Group, Inc. is a clinical stage biopharmaceutical company, which engages in the development and commercialization of immunotherapeutic for cancer indications. Its product pipeline include galinpepimut-S and nelipepimut-S. The company was founded by Angelos M. Stergiou on April 3, 2006 and is headquartered in New York, NY.

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SELLAS Life Sciences Group, Inc. is a clinical stage biopharmaceutical company, which engages in the development and commercialization of immunotherapeutic for cancer indications. Its product pipeline includes galinpepimut-S and nelipepimut-S. The company was founded by Angelos M. Stergiou on April 3, 2006 and is headquartered in New York, NY.

-  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 indications, today announced that the pre-specified threshold of 60 events (deaths) has been reached in its ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), triggering the interim analysis to be conducted by the Independent Data Monitoring Committee (IDMC). The IDMC will conduct a thorough review of the current REGAL data, and the interim analysis will provide an assessment of efficacy, futility as well as safety of GPS.

SELLAS Life Sciences Triggers Interim Analysis in Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia

- 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 -

SELLAS Announces Positive Overall Survival and Overall Response Rate Data from the Phase 2 Trial of SLS009 in r/r AML

- 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 –

SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers

– 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 –

SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update

FRIEDBERG, Germany--(BUSINESS WIRE)--voxeljet AG (OTCMKTS: VJTTY) (the ‘Company', ‘voxeljet', or ‘we'), a provider of high-speed, large-format 3D printers and on-demand parts services to industrial and commercial customers, Dressler Group GmbH, and Fraunhofer IPA today announced the successful completion of a material study for waste PA12 powder from laser-based 3D printing systems. In the study, waste powder from Selective Laser Sintering systems was successfully recycled by Dressler Group and.

voxeljet, Dressler Group GmbH, Fraunhofer IPA and the University of Bayreuth Collaborate in Re-Processing of Discarded PA12 Powder for 3D Printing via High-Speed Sintering (HSS)

- Presentation at ASH will Feature Results from the Phase 2a Trial of SLS009 in Relapsed/Refractory Acute Myeloid Leukemia After Venetoclax Failure –

SELLAS Life Sciences to Present at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition 2024

- 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 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 Rare Pediatric Disease Designation (RPDD) to Galinpepimut-S (GPS), an immunotherapeutic targeting Wilms Tumor-1 (WT1), for the treatment of pediatric acute myeloid leukemia (AML). “GPS has already demonstrated promise in clinical settings for AML, and we believe its potential could extend to pediatric patients,” said Angelos Stergiou, MD, ScD h.c.

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia

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.

SELLAS Life Sciences to Participate in Fireside Chat at the 2024 Maxim Healthcare Virtual Summit

Galena Biopharma (SLS) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Galena Biopharma (SLS) Upgraded to Buy: Here's Why

- 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 -

SELLAS Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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 (PTCL).

SELLAS Receives EMA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas

- Acute Myeloid Leukemia (AML) is the Second Most Common Hematological Malignancy in Children Often Associated with Poorer Prognosis Compared to Other Pediatric Cancers –

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia

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 treatment of acute myeloid leukemia (AML).

SELLAS Receives European Medicines Agency Orphan Drug Designation for SLS009 for the Treatment of Acute Myeloid Leukemia

- 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 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 Rare Pediatric Disease Designation (RPDD) to SLS009, a highly selective CDK9 inhibitor, for the treatment of pediatric acute lymphoblastic leukemia (ALL).   “We are pleased that the FDA has granted Rare Pediatric Disease Designation to SLS009 for the treatment of pediatric ALL, the most common cancer diagnosed in children,” said Angelos Stergiou, MD, ScD h.c.

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia

–  The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications –

SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia

- 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 Cohort to Date - - Trial Continues with Two Expansion Cohorts of Patients with ASXL1 Mutations and Myelodysplasia-Related Molecular Mutations Other Than ASXL1; Additional Update Expected in Q3 2024 - NEW YORK, June 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 the completion of enrollment as well as positive initial data from the ongoing Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML).

SELLAS Announces Completion of Enrollment and Initial Positive Data in Phase 2a Trial of SLS009 in r/r AML

Galena Biopharma (SLS) Upgraded to Buy: Here's What You Should Know

- 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 -

SELLAS Life Sciences Reports First Quarter 2024 Financial Results and Provides Corporate Update

- 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 –

SELLAS Announces Positive Phase 2 Preliminary Data of SLS009 in r/r AML Achieving a 100% Response Rate in Patients with ASXL1 Mutation At the Optimal Dose Level

– 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 –

SELLAS Life Sciences Announces Positive Recommendation of Independent Data Monitoring Committee Following Completion of Enrollment in REGAL Phase 3 Study

SELLAS Life Sciences Group, Inc. is a late-stage biotech company with a leading drug candidate, Galinpepimut-S, or GPS, that has a 44% probability of success and a potential 9x return. GPS is an immunotherapy drug targeting the Wilms Tumor 1 antigen, which is overexpressed in AML patients. The AML market size is estimated to be $3.1 billion. The upcoming interim readout of the GPS phase 3 clinical trial in April could significantly impact the valuation of the drug, with a successful trial potentially increasing its value to $1.5B.

Sellas Life Sciences Group: A Lottery Ticket With An Estimated 9x Payout

NEW YORK, March 28, 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 reported financial results for the full year ended December 31, 2023, and provided a corporate update.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

- Phase 3 REGAL Study of GPS in AML: Enrollment Completed; Steering Committee Guided Interim Analysis Imminent; IDMC Now Scheduled in Late April -

SELLAS Announces Positive Topline Data from the Phase 2a Study of SLS009 in r/r AML and Provides Steering Committee Update on Phase 3 REGAL Study

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) and warrants to purchase up to an aggregate of 13,029,316 shares of common stock issued in a concurrent private placement (together with the registered direct offering, the "Offering") at a combined purchase price of $1.535 per share and accompanying warrant, priced at-the-market under Nasdaq rules. The warrants have an exercise price of $1.41 per share, are immediately exercisable upon issuance and will expire 5.5 years from issuance.

SELLAS Life Sciences Group Announces Closing of $20 Million Registered Direct Offering and Concurrent Private Placement Priced At-the-Market Under Nasdaq Rules

-  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 indications, today announced that it will host a corporate update call on March 26, 2024, at 8:15 am ET. Angelos Stergiou, MD, ScD h.c.

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