Core Viewpoint - SELLAS Life Sciences Group, Inc. is advancing its Phase 3 REGAL trial for GPS as a potential maintenance therapy in patients with acute myeloid leukemia (AML) after second complete remission, with the trial currently reporting 72 events as of December 26, 2025, and awaiting the 80 events needed for final analysis [1][3][7] Group 1: Trial Update - The Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 REGAL trial continue without modification, with expectations that the required 80 events (deaths) for final analysis would occur before year-end [2] - As of December 26, 2025, the trial has recorded 72 events, and SELLAS remains blinded to all efficacy and survival data outcomes, meaning this update does not affect future statistical analyses [3][7] - The final analysis is event-driven, and the company will announce when the 80th event occurs [3][7] Group 2: Company Commitment and Expert Insights - The CEO of SELLAS expressed appreciation for the dedication of participants in the REGAL trial, noting that survival times appear longer than expected, which may increase the probability of a successful study [4] - Dr. Yair Levy, a member of the REGAL Steering Committee, highlighted the significance of the REGAL study in evaluating GPS for AML patients who cannot undergo transplant, with an expected median overall survival of around eight months for current treatments [4] - The company is committed to advancing breakthrough therapies like GPS that have the potential to significantly improve patient outcomes in AML [4] Group 3: About the REGAL Trial - The REGAL trial (NCT04229979) is a Phase 3 randomized registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy [5] - The primary endpoint of the trial is overall survival, and the IDMC is responsible for monitoring patient safety and efficacy data [5] Group 4: About SELLAS Life Sciences - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for various cancer indications, with its lead product candidate GPS targeting the WT1 protein present in multiple tumor types [6] - The company is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [8]

Core Insights - SELLAS Life Sciences Group, Inc. announced promising clinical data for SLS009, a CDK9 inhibitor, in combination with azacitidine and venetoclax for treating relapsed or refractory acute myeloid leukemia with myelodysplastic syndrome-related changes [1][3] Group 1: Clinical Study Details - The Phase 2 study involved 35 evaluable patients with a median age of 69, where 98% had ELN adverse-risk AML, with common mutations including ASXL1, RUNX1, TP53, and SRSF2 [2] - The overall response rate for SLS009 in combination with AZA/VEN was 46%, with 29% achieving complete response (CR) or CR with incomplete blood count recovery (CRi) [3] - Patients with ASXL1 and TP53 mutations had response rates of 48% and 57%, respectively, with median overall survival (mOS) significantly exceeding the expected 2.6 months [3] Group 2: Safety and Tolerability - No dose-limiting toxicities (DLTs) or treatment-related deaths were reported, indicating that the combination therapy was well tolerated [3][5] - The combination therapy demonstrated a median overall survival of 8.9 months in the least pretreated cohort, with a 58% response rate in patients with one prior line of therapy [5] Group 3: Future Plans and Implications - The company plans to expand the study to evaluate SLS009 plus AZA/VEN in newly diagnosed AML with high-risk features in Q1 2026 [5] - The results suggest that SLS009 may effectively overcome resistance to venetoclax-based regimens by targeting MCL-1, a key resistance mechanism in AML [4]

Core Insights - SELLAS Life Sciences Group, Inc. reported positive developments in its clinical programs, particularly for SLS009 and GPS, with significant upcoming milestones and a strong financial position [1][2][3] Financial Performance - As of September 30, 2025, the company had cash and cash equivalents totaling approximately $44.3 million, with an additional $29.1 million received from warrant exercises in October 2025 [1][11] - Research and development expenses for Q3 2025 were $4.2 million, a decrease from $4.4 million in Q3 2024, primarily due to reduced clinical trial expenses [8] - General and administrative expenses for Q3 2025 were $2.9 million, slightly down from $3.0 million in Q3 2024, attributed to lower professional fees [9] - The net loss for Q3 2025 was $6.8 million, or a loss per share of $0.06, compared to a net loss of $7.1 million, or $0.10 per share, in Q3 2024 [10][16] Clinical Developments - The Phase 3 REGAL trial of GPS is progressing as planned, with a final analysis expected by year-end 2025 after reaching 80 events [3] - Positive Phase 2 data for SLS009 in relapsed/refractory AML has been accepted for presentation at the ASH Annual Meeting in December 2025, with plans for an 80-patient trial in newly diagnosed AML patients expected to start in Q1 2026 [4][6] - Preclinical data presented at ESMO 2025 showed significant survival benefits of SLS009 in T-cell prolymphocytic leukemia (T-PLL), supporting its potential across various hematologic malignancies [5] Corporate Events - A virtual R&D Day was held on October 29, 2025, showcasing the company's ongoing clinical trials and receiving positive feedback from key opinion leaders [6] - The company raised approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025, enhancing its financial foundation [7]

Core Insights - SELLAS Life Sciences Group, Inc. is advancing its late-stage clinical biopharmaceutical development, particularly focusing on SLS009 for relapsed or refractory acute myeloid leukemia (r/r AML) [1][2] - The Phase 2 study of SLS009 will be presented at the upcoming ASH Annual Meeting, highlighting its potential in combination with azacitidine and venetoclax [1][3] - The company emphasizes the growing evidence supporting SLS009's efficacy across hematologic malignancies, with preclinical data demonstrating its cytotoxic effects on AML cell lines [2][4] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company dedicated to developing novel therapies for various cancer indications, with a lead product candidate, GPS, targeting the WT1 protein [4] - SLS009, a CDK9 inhibitor, is positioned as a potentially first-in-class treatment with reduced toxicity and increased potency compared to existing CDK9 inhibitors [4] - The company aims to address significant unmet needs in treating difficult-to-manage cancers, particularly in patients with unfavorable prognostic factors like ASXL1 mutations [4]

Core Viewpoint - SELLAS Life Sciences Group, Inc. has announced the immediate exercise of existing warrants, resulting in gross cash proceeds of approximately $31.0 million for the purchase of up to 22,363,714 shares of common stock [1][2]. Group 1: Financial Transaction - The immediate exercise of the existing warrants will provide the company with gross cash proceeds of about $31.0 million [1]. - Investors exercising the existing warrants will receive new registered warrants to purchase the same number of shares at an exercise price of $2.00, which will be exercisable immediately and will expire five years from issuance [2]. - The transaction is expected to close on or about October 28, 2025, pending customary closing conditions [2]. Group 2: Advisory and Registration - A.G.P./Alliance Global Partners and Maxim Group LLC acted as financial advisors for this transaction [3]. - The offering is being made under an effective shelf registration statement on Form S-3 previously filed with the U.S. Securities and Exchange Commission [4]. Group 3: Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [7]. - The company's lead product candidate, GPS, targets the WT1 protein and has potential applications in treating a wide range of hematologic malignancies and solid tumors [7]. - SELLAS is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [7]. Group 4: Upcoming Events - SELLAS will host a virtual R&D Day on October 29, 2025, featuring key opinion leaders and company management to discuss the treatment landscape for acute myeloid leukemia [5].

Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [2] - The lead product candidate, GPS, targets the WT1 protein found in multiple tumor types and has potential as both a monotherapy and in combination with other therapies [2] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor, which shows a high response rate in AML patients with unfavorable prognostic factors [2] Event Participation - Dr. Angelos Stergiou, President and CEO of SELLAS, will participate in the J.P. Morgan U.S. Opportunities Forum on November 12, 2025 [1] - The event will take place at the Kimpton EPIC Hotel in Miami, Florida, and will consist of 1x1 investor meetings [2]

Core Insights - BlackRock has acquired a 5.4% ownership stake in Sellas Life Sciences Group, amounting to 5,686,886 shares, granting it voting control in the company [1][2] - Sellas Life Sciences has shown strong stock performance, with a 38% increase in after-hours trading and a 100% year-to-date gain [2] - The company is making significant clinical progress, particularly with its lead candidate, galinpepimut-S (GPS), currently in a Phase 3 trial for acute myeloid leukemia (AML) [4][5] Company Overview - Sellas Life Sciences is a late-stage biotechnology firm focused on developing treatments for cancer, specifically AML [4] - The company has two key programs: galinpepimut-S (GPS) and SLS009 (tambiciclib), both targeting AML [5][6] Clinical Developments - The REGAL trial for GPS has shown promising results, with median survival exceeding 13.5 months, which is more than double the historical average for standard treatments [5] - SLS009 has demonstrated encouraging Phase 2 results and has received Fast Track and Orphan Drug designations from the FDA [6][7] Market Implications - BlackRock's investment indicates growing institutional confidence in Sellas's long-term potential, despite the inherent risks associated with biotech investments [7] - Future valuation of Sellas will likely depend on the outcomes of the REGAL trial, which could significantly impact the company's market position if early survival benefits are confirmed [8]

Core Insights - Biotech stocks experienced a significant after-hours rally, with SOPHiA GENETICS and SELLAS Life Sciences leading the gains due to positive announcements regarding upcoming data presentations [1][2]. Company Highlights - SOPHiA GENETICS (SOPH) saw its shares increase by nearly 10%, closing at $4.44 [3]. - SELLAS Life Sciences Group Inc. (SLS) shares rose by 3.5% to $2.07 after announcing the presentation of preclinical efficacy data for its CDK9 inhibitor, SLS009, at the ESMO Congress 2025 [2]. - Other notable biotech companies that experienced stock price increases include Ironwood Pharmaceuticals (up 6.76% at $1.58), Spectral AI (up 8.60% at $2.40), and Adverum Biotechnologies (up 7.21% at $4.46) [3].

Core Insights - Preclinical data supports SLS009 as a promising treatment for T-cell prolymphocytic leukemia (T-PLL), both as a monotherapy and in combination with venetoclax [1][2][3] Group 1: Efficacy of SLS009 - SLS009 demonstrated significant single-agent activity and improved overall survival in a patient-derived xenograft model of relapsed/refractory T-PLL, with survival times of 7.4 weeks for SLS009 monotherapy and 7.9 weeks for the combination with venetoclax, compared to 4.4 weeks for venetoclax alone [2][3] - The combination of SLS009 and venetoclax was well tolerated, indicating a favorable safety profile [2][3] Group 2: Research Presentation - The findings will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, scheduled for October 17-21, 2025, in Berlin, Germany [1][4] - The poster presentation is titled "CDK9 Inhibition Enhances Venetoclax Activity and Prolongs Survival in a T-PLL Patient-Derived Xenograft Model" [4] Group 3: Company Overview - SELLAS Life Sciences Group, Inc. is focused on developing novel therapies for various cancer indications, with SLS009 being a key candidate as a differentiated small molecule CDK9 inhibitor [5][6] - The company also has a lead product candidate, GPS, which targets the WT1 protein and has potential applications in multiple hematologic malignancies and solid tumors [5]

Core Insights - SELLAS Life Sciences Group, Inc. is hosting a virtual R&D Day on October 29, 2025, to discuss the treatment landscape for acute myeloid leukemia (AML) and the unmet medical needs in this area [1][2] Group 1: Event Details - The R&D Day will feature key opinion leaders and company management discussing the ongoing Phase 3 REGAL trial of GPS, with results expected by year-end [2] - An update on SLS009, a selective CDK9 inhibitor, will be presented, including recent Phase 2 data and plans for a new AML study starting in Q1 2026 [2] Group 2: Key Opinion Leaders - Dr. Omer Jamy is a principal investigator of the REGAL study and focuses on AML and related therapies [4] - Dr. Panagiotis Tsirigotis is an investigator in the REGAL trial, emphasizing cellular therapies and hematopoietic cell transplantation [5] - Dr. Philip Amrein specializes in leukemias and has conducted research with SLS009 [6] - Dr. Sharif Khan is involved in both the REGAL trial and the SLS009 clinical program, focusing on breakthrough therapies [7] Group 3: Company Overview - SELLAS is a late-stage clinical biopharmaceutical company developing novel therapies for various cancer indications, with GPS targeting the WT1 protein [8] - SLS009 is positioned as a potentially first-in-class CDK9 inhibitor, showing high response rates in AML patients with unfavorable prognostic factors [9]