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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 (SLS) has signed an exclusive license agreement with 3D Medicines for the development and commercialization of Galinpepimut-S (GPS) in China, receiving a $7.5 million upfront fee and potential total payments of $202 million. As of December 31, 2020, SELLAS reported cash and equivalents of $35.3 million, a significant increase from prior periods. The ongoing Phase 3 REGAL study in Acute Myeloid Leukemia has expanded to approximately 135 clinical sites. Additionally, preliminary clinical data show promising results for GPS in combination with therapies for ovarian cancer and mesothelioma.
SELLAS Life Sciences Group (Nasdaq: SLS) announced that its CEO, Angelos Stergiou, will participate in the Emerging Growth Virtual Conference on March 17, 2021. He will discuss developments in cancer immunotherapies and participate in a Cancer Vaccines Panel at 1:00 p.m. ET. The focus will be on market opportunities and milestones for cancer vaccines. An archived replay will be available on SELLAS' investor relations website. Additionally, SELLAS is advancing its lead product candidate, galinpepimut-S, targeting the WT1 protein across various cancers.
SELLAS Life Sciences Group has initiated its pivotal Phase 3 REGAL study of Galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients across the U.S. and Europe. In partnership with 3D Medicines, it has begun commercialization of GPS in China, backed by a $35.3 million cash reserve as of December 31, 2020. Preliminary results from its Phase 2 study indicate a median overall survival of 21 months for GPS-treated AML patients. The company's strong financial position will support ongoing clinical programs and potential future royalties from the 3D Medicines agreement may reach $202 million.
SELLAS Life Sciences Group announced early data from two clinical studies of galinpepimut-S (GPS) in combination with checkpoint inhibitors for advanced cancers. The first study showed an 87.5% disease control rate in patients with WT1(+) ovarian cancer at a median follow-up of 9.4 weeks, with 100% progression-free survival at 6 weeks. The second study in mesothelioma indicated a median progression-free survival of at least 10 weeks. Further data is expected by mid-2021.
SELLAS Life Sciences Group, Inc. (SLS) announced on December 17, 2020, the successful closing of a registered direct offering, generating net proceeds of approximately $14.9 million. Additionally, the exercise of warrants contributed $8.1 million to the company's finances. This funding will support the development programs for their lead candidate, galinpepimut-S (GPS), particularly the ongoing Phase 3 trial for acute myeloid leukemia (AML). An anticipated non-dilutive license fee of $7.5 million from 3D Medicines will further bolster their cash position.
SELLAS Life Sciences Group (Nasdaq: SLS) announced a registered direct offering of approximately $16.2 million of its common stock at $7.00 per share, set to close around December 16, 2020. The company will sell 2,320,000 shares, expecting gross proceeds before fees and expenses. Maxim Group LLC acts as the exclusive lead placement agent for this offering. The shares are offered under a previously filed shelf registration statement and do not constitute an offer in jurisdictions where sales would be unlawful.
SELLAS Life Sciences Group (Nasdaq: SLS) announced positive results from its Phase 2 VADIS trial of nelipepimut-S (NPS) for ductal carcinoma in situ (DCIS) patients. The study showed a significant long-term immune response, with NPS+GM-CSF treatments increasing specific T-cell responses by up to 1,300% compared to control. The results, presented at the San Antonio Breast Cancer Symposium, suggest NPS may enhance immunity against HER2-expressing breast cancer. No serious adverse reactions were reported, supporting further development of NPS.
SELLAS Life Sciences Group has announced an Exclusive License Agreement with 3D Medicines, allowing the latter to develop and commercialize SELLAS' lead candidate, galinpepimut-S (GPS), in Greater China. SELLAS can earn up to $202 million, including a $7.5 million upfront fee and $8 million in near-term milestones, plus tiered royalties from sales. The deal enhances SELLAS' financial position and expands GPS's market reach, while 3D Medicines will handle development costs in China.
SELLAS Life Sciences Group has received approval for the Phase 3 REGAL study of galinpepimut-S in acute myeloid leukemia (AML) patients, allowing enrollment in France. The company strengthened its balance sheet with a $9.2 million financing, aimed at supporting ongoing clinical studies. Net loss for Q3 2020 was $4.5 million, a decrease from $11.5 million in Q3 2019. Cash and cash equivalents stood at approximately $8.2 million as of September 30, 2020. Challenges due to COVID-19 are affecting patient enrollment timelines.
SELLAS Life Sciences Group (SLS) announced the approval of its Investigational Medicinal Product Dossier (IMPD) by the French regulatory authority for its Phase 3 REGAL study of galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) patients who have achieved complete remission. This milestone allows for increased patient enrollment in France. Previous data from a Phase 2 study indicated a median overall survival of 21.0 months for GPS-treated patients, compared to 5.4 months with standard care. The REGAL study aims to evaluate overall survival and other key clinical endpoints.
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