SEELAS Life Sciences (SLS)

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SELLAS Announces Positive Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL
GlobeNewswire· 2025-02-20 13:45
- 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 on the development of novel therapies for a broad range of cancer indications ...
SELLAS Life Sciences Group Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
GlobeNewswire· 2025-01-28 20:11
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 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to ...
SELLAS Life Sciences Announces Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia
GlobeNewswire· 2025-01-23 13:10
- 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 Integrity - - Fewer than 50% of Enrolled Patients Confirmed Deceased After the Med ...
SELLAS Announces Key Business Objectives for 2025
Newsfilter· 2025-01-08 13:20
Business Update and Milestones - SELLAS Life Sciences expects 2025 to be a pivotal year with several transformative clinical milestones, including full topline Phase 2 data for SLS009 in AML and FDA regulatory feedback in 1H 2025 [2] - The interim analysis of the Phase 3 REGAL study for GPS in AML is expected in January 2025, with the IDMC providing recommendations on whether to stop the trial early for efficacy, futility, or continue without modification [2][3] - The Phase 3 REGAL study reached the pre-specified threshold of 60 events (deaths), initiating the interim analysis [7] SLS009 Development and Achievements - SLS009, a highly selective CDK9 inhibitor, demonstrated a 56% ORR in AML-MRC patients with ASXL1 mutation and other cytogenic changes, exceeding the pre-specified target response rate of 33% [11] - The median overall survival (mOS) for SLS009 in r/r AML has not been reached but exceeds 7.7 months, significantly higher than the historical mOS of 2.5 months [11] - SLS009 showed a 50% response rate in combination with azacitidine and venetoclax at the optimal dose level of 30 mg twice a week, with higher clinical activity in AML-MRC patients, particularly those with ASXL1 mutations [11] - The WHO approved "tambiciclib" as the recommended International Nonproprietary Name (INN) for SLS009 [11] Regulatory Designations - GPS received FDA Rare Pediatric Disease Designation (RPDD) for pediatric AML [9] - SLS009 received RPDD for pediatric AML and pediatric ALL, FDA Fast Track Designation for AML, and EMA orphan drug designation for AML and peripheral T-cell lymphoma [9] Clinical Trial Progress - Enrollment for the Phase 2a trial of SLS009 in r/r AML was completed ahead of schedule, with 30 patients enrolled across 5 US centers [11] - Two new Phase 2 cohorts for SLS009 in AML-MRC with ASXL1 mutations and other cytogenic changes were opened, including enrollment for certain pediatric patients [11] Preclinical and Research Developments - Preclinical data indicated ASXL1 mutations as predictors of response to SLS009 in solid cancers [11] - Research published in Oncotarget revealed the mechanisms of action behind the anti-proliferative effects of SLS009 in hematologic malignancies [11] - The National Cancer Institute (NCI) Pediatric Preclinical in Vivo Testing (PIVOT) Program continues to evaluate SLS009 in pediatric tumors [11] Corporate and Financial Updates - SELLAS applied for non-dilutive grant funding to expand SLS009 development into the frontline setting in AML [5] - The company is developing SLS009 pediatric programs for hematological and potentially other malignancies [5] - SELLAS hosted a corporate update webinar on January 8, 2025, to discuss its 2025 business outlook [5][10]
Solaris Expands Leadership Team
GlobeNewswire· 2025-01-08 12:00
Leadership Team Expansion - Solaris Resources Inc has strengthened its leadership team with the appointment of Richard Hughes as Chief Financial Officer and Company Secretary, Patrick Chambers as Vice President Investor Relations, and Ignacio Shimamoto as Vice President Finance, effective immediately [1] - Richard Hughes, with over 20 years in the natural resources sector, will lead the finance function leveraging his recent experience as CFO and Executive Director of Trident Royalties PLC, which was recently acquired [2] - Patrick Chambers will drive global investor engagement, leveraging his strong geological, investor relations, and business development background, with a focus on Latin America [2] - Ignacio Shimamoto will lead financial strategy, focusing on enhancing operational efficiency, strengthening compliance, and supporting the company's growth through strategic planning, financial oversight, and valuations of projects and investments [2] New Appointments Background - Richard Hughes has over 20 years of experience in the natural resources sector, with significant knowledge across strategy, capital markets, and corporate finance, and most recently served as CFO and Executive Director of Trident Royalties PLC [4] - Patrick Chambers is a metals and mining investor relations professional with an extensive track record across a range of commodities, focusing on Latin America, and most recently served as Head of Investor Relations at Horizonte Minerals [6] - Ignacio Shimamoto is a senior finance executive with over 20 years of experience in financial planning, business improvement, acquisitions, and cost optimization within the natural resources sectors, having served as Finance Manager for Copper Peru at Glencore [7][8] Company Overview - Solaris Resources Inc is a copper-gold exploration and development company, committed to a sustainable future through participatory and responsible mining [10] - The Warintza Project, a large copper-gold porphyry deposit, has a disclosed resource endowment of over 2.3 billion tonnes and is located in southeast Ecuador [10] - The company also owns a series of grassroots exploration projects with discovery potential in Peru and Chile, and a 60% interest in the La Verde joint-venture project with a subsidiary of Teck Resources in Mexico [10] Final Emigration Steps - The company announces that the final emigration steps are now complete, subject to a few administrative matters [9]
SELLAS Announces Positive Data from Preclinical Studies Indicating ASXL1 Mutations as Predictor of Response to SLS009 in Solid Cancers
GlobeNewswire News Room· 2024-11-27 13:45
- 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 Solid Cancers - ...
SEELAS Life Sciences (SLS) - 2024 Q3 - Quarterly Results
2024-11-13 21:17
Exhibit 99.1 SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update - 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) f ...
SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update
GlobeNewswire News Room· 2024-11-13 21:15
– 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) -- SELLAS Life Sciences Group, I ...
SEELAS Life Sciences (SLS) - 2024 Q3 - Quarterly Report
2024-11-13 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________________ FORM 10-Q ________________________________ Title of each class Trading symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share SLS The Nasdaq Stock Market LLC Emerging growth company ☐ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 1 ...
SELLAS Life Sciences to Participate in Fireside Chat at the 2024 Maxim Healthcare Virtual Summit
GlobeNewswire News Room· 2024-10-10 20:05
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 Virtual Summit Details: ...