SLS009 (tambiciclib)
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SELLAS Life Sciences Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-12 21:05
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]
SELLAS Life Sciences Announces Presentation of Phase 2 Data of SLS009 in Combination with Azacitidine and Venetoclax in Relapsed/Refractory AML with MDS-Related Changes (AML-MR) at the 2025 American Society of Hematology (ASH) Annual Meeting
Globenewswire· 2025-11-03 14:00
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]
SELLAS Life Sciences Group Announces Exercise of Existing Warrants Held by a Current Institutional Investor for $31 Million in Gross Proceeds
Globenewswire· 2025-10-27 12:30
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].
SELLAS Life Sciences to Participate in the J.P. Morgan U.S. Opportunities Forum
Globenewswire· 2025-10-22 13:00
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]
BlackRock just bought this stock with full voting control
Finbold· 2025-10-18 11:28
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]
Biotech Stocks Surge After Hours On Trial Updates, Data Momentum
RTTNews· 2025-10-14 03:35
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].
SELLAS Life Sciences to Present In Vivo Preclinical Data Demonstrating Statistically Significant Survival Benefit of SLS009 in T-Cell Prolymphocytic Leukemia at the European Society for Medical Oncology (ESMO) Congress 2025
Globenewswire· 2025-10-13 12:00
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]
SELLAS Life Sciences Group to Host Virtual R&D Day on October 29, 2025: Advancing Novel Therapies in Acute Myeloid Leukemia (AML): An Overview of the Ongoing Phase 3 REGAL Trial of Galinpepimut-S (GPS) and SLS009 Program Update
Globenewswire· 2025-09-30 12:30
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]
SELLAS Life Sciences Group Announces Exercise of Existing Warrants Held by a Current Institutional Investor for $23.6 Million in Gross Proceeds
Globenewswire· 2025-09-11 12:30
Core Points - SELLAS Life Sciences Group, Inc. announced the immediate exercise of warrants to purchase up to 19,685,040 shares of common stock for gross cash proceeds of approximately $23.6 million [1][2] - The investor will receive new unregistered warrants at an exercise price of $1.88, which will be exercisable immediately and will expire in five years and six months [2] - The transaction is expected to close on or about September 12, 2025, subject to customary closing conditions [2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [6] - The lead product candidate, GPS, targets the WT1 protein present in multiple tumor types and has potential as both a monotherapy and in combination with other therapies [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 [6]
Sellas Life Sciences: SLS009's Phase 2 Sets Up A Promising 2026
Seeking Alpha· 2025-08-20 01:18
Company Overview - SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a clinical-stage biopharmaceutical company focused on developing cancer therapies, particularly for hematologic malignancies [1] - The company's pipeline includes two candidates: Galinpepimut-S (GPS) and SLS009 (tambiciclib) [1] Product Pipeline - Galinpepimut-S (GPS) is an immunotherapy currently in Phase 3 clinical trials for acute myeloid leukemia (AML) [1] - SLS009 (tambiciclib) is another candidate in the company's pipeline, although specific details about its development stage are not provided [1]