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SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a late-stage clinical biopharmaceutical company dedicated to the development of novel therapeutics aimed at addressing a broad range of cancer indications. The company's core mission is to practice the medicine of tomorrow, today, by integrating innovative approaches that significantly impact the global healthcare landscape.
SELLAS' leading product candidate is galinpepimut-S (GPS), a peptide immunotherapy targeting the Wilms Tumor 1 (WT1) antigen. Licensed from Memorial Sloan Kettering Cancer Center, GPS is designed to treat various hematologic malignancies and solid tumors. Notably, GPS is currently undergoing a Phase 3 REGAL clinical trial for acute myeloid leukemia (AML), with promising safety and efficacy data observed so far.
Another pivotal asset in SELLAS' pipeline is SLS009 (formerly GFH009), a highly selective cyclin-dependent kinase 9 (CDK9) inhibitor. Licensed from GenFleet Therapeutics (Shanghai), Inc., SLS009 is being explored for its potential to treat relapsed/refractory acute myeloid leukemia (r/r AML) and other cancer types. Recent Phase 2a trial results show that SLS009 exhibits strong anti-leukemic activity, with favorable safety profiles and significant response rates, particularly in patients with identified biomarkers such as the ASXL1 mutation.
SELLAS is committed to advancing these therapeutics through rigorous clinical trials and strategic partnerships. The company collaborates with renowned scientists, healthcare professionals, and pharmaceutical executives to bring cutting-edge treatments to market. Recent collaborations include a clinical trial agreement with BeiGene Switzerland GmbH to study the combination of GFH009 and BRUKINSA® (zanubrutinib) in treating diffuse large B cell lymphoma (DLBCL).
Financially, SELLAS has shown resilience and growth, as evidenced by a successful $20 million registered direct offering in March 2024, bolstering their cash reserves for ongoing R&D activities. The company continues to report sound financial health, marked by a focused approach on strategic developments and clinical milestones.
For more information on SELLAS Life Sciences Group, Inc. and its innovative therapies, visit their official website at www.sellaslifesciences.com.
SELLAS Life Sciences Group has received approval from China's NMPA for an IND application to begin the first clinical trial of 3D189 (GPS) in China, scheduled for mid-2022. This milestone triggers a $1 million payment to SELLAS, which it expects in Q2 2022. The potential total milestone payments from the licensing agreement with 3D Medicines could reach $191.5 million, excluding future royalties. GPS targets the WT1 protein in various cancers, offering hope for improved patient outcomes.
SELLAS Life Sciences Group (NASDAQ: SLS) announced significant advancements in Q1 2022, including the in-licensing of GFH009, a selective CDK9 inhibitor from GenFleet Therapeutics, which aims to enhance their cancer therapy pipeline. The company closed a public offering raising $25 million for its development projects, including the GPS treatment for acute myeloid leukemia and other cancers. Key organizational changes include the appointment of Robert Francomano as Chief Commercial Officer. Enrollment in the Phase 1/2 GPS study with KEYTRUDA is completed, and an IND for GPS in China is approved.
SELLAS Life Sciences Group (NASDAQ: SLS) announced a public offering of 4,629,630 shares of its common stock and accompanying warrants at a price of $5.40 per share. The offering is expected to generate gross proceeds of $25 million before deducting costs. The securities will be sold by the company and the offering is set to close on April 5, 2022, subject to customary conditions. SVB Leerink and Cantor are the joint book-running managers for this offering. The securities are part of a shelf registration statement previously filed with the SEC.
SELLAS Life Sciences Group (Nasdaq: SLS) has initiated an underwritten public offering of its common stock and associated warrants, with all securities sold by the company. SVB Leerink and Cantor are the joint book-running managers for this offering, which is subject to market conditions. The offering will be conducted under a previously filed shelf registration statement. SELLAS is focused on developing novel cancer therapies, notably GPS and GFH009, potentially addressing various malignancies. The completion details depend on market and closing condition satisfaction.
SELLAS Life Sciences Group has entered a license agreement with GenFleet Therapeutics for worldwide rights to develop GFH009, a selective CDK9 inhibitor, outside Greater China. GFH009 is currently in Phase 1 trials in the U.S. and China, showing promising early results and lower toxicity compared to older versions. SELLAS plans to initiate multiple Phase 2 trials in 2023 for hematological malignancies and pediatric soft tissue sarcomas. The financial terms include an initial $10 million payment and potential milestone payments totaling up to $140 million.
SELLAS Life Sciences Group has appointed Robert Francomano as Chief Commercial Officer, effective immediately. With over 25 years of experience in the biopharmaceutical sector, Francomano previously led Stemline Therapeutics through its transition to full commercialization. His expertise is expected to significantly contribute to SELLAS’s pipeline, particularly with its lead candidate, galinpepimut-S (GPS), which targets various tumor types. CEO Angelos Stergiou expressed confidence in Francomano’s capabilities, hoping to advance the company's mission in cancer therapies.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) announced on February 28, 2022, that the United States District Court for the District of New Jersey approved a $1.6 million settlement related to litigation involving its predecessor, Galena Biopharma. The settlement, fully covered by insurance, resolves all legacy legal claims. CEO Angelos M. Stergiou expressed satisfaction with the modest settlement, emphasizing the company's focus on developing innovative cancer immunotherapies. SELLAS's lead candidate, galinpepimut-S, targets the WT1 protein in various tumors.
SELLAS Life Sciences Group (NASDAQ: SLS) has completed enrollment in a Phase 1/2 clinical trial for its lead asset, galinpepimut-S (GPS), in combination with Merck’s KEYTRUDA® for advanced ovarian cancer. The trial aims to assess safety and efficacy in 17 patients, with interim data expected by mid-2022 and final results by the end of 2022. This milestone reflects SELLAS's commitment to improving treatment options for difficult-to-treat patients, despite challenges posed by COVID-19.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has had its IND application accepted by China’s NMPA to initiate a Phase I trial of 3D189 (GPS) for hematological malignancies, expected to start in mid-2022. This milestone will trigger a payment to SELLAS, with additional payments linked to further trials. GPS has shown encouraging results in prior studies and aims to improve outcomes for cancer patients globally. Collaboration with 3D Medicines may also extend to ongoing Phase III trials in AML, enhancing their combined treatment options.
SELLAS Life Sciences Group (NASDAQ: SLS) has announced the promotion of John T. Burns to Senior Vice President, Finance, and Chief Accounting Officer. Burns, who joined SELLAS in 2013, has played a vital role in the company’s financial strategy and execution. His promotion reflects his contributions to the company’s growth, particularly in advancing its clinical programs for cancer immunotherapies. SELLAS is developing innovative treatments, including galinpepimut-S and nelipepimut-S, targeting various cancer types.
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