Core Insights - SELLAS Life Sciences Group, Inc. announced promising results from Cohort 3 of the Phase 2 trial for SLS009, a CDK9 inhibitor, showing a median overall survival (mOS) of 8.9 months in patients with AML-MRC and 8.8 months in all relapsed or refractory patients, significantly surpassing the historical benchmark of 2.5 months [1][2] - The overall response rate (ORR) achieved was 67% in AML-MRC patients and 46% in all evaluable patients, exceeding the targeted ORR of 20% [1][2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with SLS009 being a key candidate [7] - The company aims to address critical unmet medical needs in heavily pretreated AML patients, particularly those with adverse genetic mutations [2][7] Trial Details - The ongoing Phase 2 trial is an open-label, single-arm, multi-center study evaluating the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine [6] - The trial has expanded to include additional cohorts targeting specific mutations, including ASXL1, to further validate the therapy's potential [6] Patient Characteristics - In Cohort 3, 14 patients were treated, with 71% having AML-MRC and a median age of 71 years [5] - The cohort included patients with various mutations, with a median of 1 prior failed therapy [5] Efficacy Results - The mOS for all patients in Cohort 3 was 8.8 months, with a 67% ORR in AML-MRC patients and 46% in all evaluable patients [5] - Specific mutation responses included 75% in myelomonocytic AML, 67% in ASXL1, 60% in RUNX1, and 33% in TP53 [5] Safety Profile - SLS009 was well-tolerated with no new safety signals observed, indicating a favorable safety profile in the patient population [5]

Financial Performance - SELLAS reported a net loss of $30.9 million for the year ended December 31, 2024, compared to a net loss of $37.3 million for 2023, representing a 17.5% improvement [13]. - The total operating expenses for 2024 were $31.5 million, down from $37.9 million in 2023, reflecting a decrease of 16.8% [19]. - As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million, up from $2.5 million in 2023 [14]. - SELLAS raised $25 million in gross proceeds from a registered direct offering in January 2025, strengthening its financial position [8]. Research and Development - Research and development expenses decreased to $19.1 million in 2024 from $24.0 million in 2023, a reduction of 20.4% primarily due to lower clinical trial and manufacturing costs [11]. - SELLAS received multiple regulatory designations in 2024, including three FDA Rare Pediatric Disease Designations and one FDA Fast Track Designation for its therapies [10]. - The company completed enrollment in the Phase 2a trial of SLS009 in r/r AML ahead of schedule, enrolling 30 patients across five centers in the US [9]. Clinical Outcomes - The overall response rate (ORR) for SLS009 in AML patients with myelodysplasia-related changes was 56%, exceeding the pre-specified target ORR of 33% [4]. - The median overall survival (mOS) for SLS009 in AML patients has not been reached but exceeds 7.7 months, compared to a historical mOS of approximately 2.5 months [9]. - The interim analysis of the Phase 3 REGAL trial of GPS in AML indicated a median survival of over 13.5 months, significantly higher than the historical median survival of 6 months for conventional therapy [5].

Core Insights - SELLAS Life Sciences Group, Inc. announced positive interim analysis results for its Phase 3 REGAL trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML), with the final analysis expected in 2025 [1][3] - The company reported promising data from the ongoing Phase 2 trial of SLS009 (Tambiciclib) in relapsed/refractory AML, with an overall response rate of 56% and a median overall survival exceeding 7.7 months [2][12] - SELLAS raised $25 million in gross proceeds from a registered direct offering in January 2025, enhancing its financial position [5][6] Clinical Development - The REGAL trial of GPS has shown preliminary signals of effectiveness, with fewer than 50% of enrolled patients confirmed deceased after a median follow-up of 13.5 months, indicating a median survival of over 13.5 months compared to the historical median of 6 months for conventional therapies [3] - The Phase 2 trial of SLS009 in AML has exceeded its prespecified target overall response rate of 33%, demonstrating a 56% response rate in patients with myelodysplasia-related changes [2][12] - Multiple regulatory designations were granted to SELLAS' programs in 2024, including FDA Rare Pediatric Disease Designations and Fast Track Designation, which may accelerate development and approval processes [2][8] Financial Performance - Research and development expenses for the year ended December 31, 2024, were $19.1 million, a decrease from $24.0 million in 2023, primarily due to reduced clinical trial expenses and a decrease in headcount [9] - General and administrative expenses decreased to $12.4 million in 2024 from $13.9 million in 2023, attributed to lower employee-related expenses and outside services [10] - The net loss for the year ended December 31, 2024, was $30.9 million, or a loss per share of $0.50, compared to a net loss of $37.3 million and a loss per share of $1.34 in 2023 [11][18] Cash Position - As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million, bolstered by the $25 million raised in January 2025 [13][5] Regulatory Achievements - The company received several regulatory designations for its therapies, including FDA Rare Pediatric Disease Designation for pediatric AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma [8]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________________ FORM 10-K ________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-33958 SELLAS Life Sciences G ...

Core Points - Solaris Resources Inc. has formed an Inter-Institutional working group with the Pueblo Shuar Arutam organization (PSHA) and local communities to enhance dialogue and cooperation [2][3][7] - The PSHA approved the signing of a Letter of Intent (LOI) to advance discussions towards a future Cooperation Agreement [3][6][7] - The company has completed an infill drilling program totaling over 80,000 meters, which will support an updated Mineral Resource Estimate (MRE) expected in mid-2025 [4][7] - The Warintza Project is positioned as a sustainable mining initiative that incorporates the insights and values of indigenous populations, aiming for responsible resource development [5][8] Company Developments - The Inter-Institutional working group aims to promote transparent dialogue and workshops to facilitate community consent for future agreements [6][8] - The Impacts and Benefits Agreement (IBA) with local Shuar Centers has been updated multiple times since its initial signing in September 2020, ensuring ongoing community support [3][7] - The company emphasizes its commitment to corporate social responsibility (CSR) through initiatives that support health, education, and sustainable development in Shuar communities [8] Project Highlights - The Warintza Project is a significant copper-gold porphyry deposit with a resource endowment of over 2.3 billion tonnes, located in southeast Ecuador [9] - The updated MRE will be integrated into the Pre-Feasibility Study (PFS) scheduled for release in Q3 2025 [4][7] - The company is focused on converting Inferred mineral resources to Measured and Indicated categories through its drilling program [4][7]

- 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 ...

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 ...

- 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]