- 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 ...

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]

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]

– 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 ...

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: ...

-Dosing of the SLS-002 cohort is expected to commence in 4Q2024 NEW YORK, Sept. 24, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinicalstage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced the signing of a Material Transfer Agreement (MTA) with the U.S. Army Medical Materiel Development Activity (USAMMDA) to supply SLS-002 (intranasal racemic ketamine) for the U.S. Department of Defense ...

Galena Biopharma, Inc. (SLS) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years. The ...

- 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 Designations and U.S. FDA ...

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). "We are pleased t ...

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). "We are pleased t ...