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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 announced the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent covering galinpepimut-S (GPS) in combination with checkpoint inhibitors for treating WT1-expressing cancers. This patent extends to at least 2036 and facilitates further clinical studies for patients with advanced ovarian cancer and malignant pleural mesothelioma. CEO Angelos Stergiou emphasized the importance of this milestone for advancing their clinical pipeline and intends to release more data later this quarter.
SELLAS Life Sciences Group (SLS) announced a milestone payment of $1.0 million from 3D Medicines under an exclusive license for Galinpepimut-S (GPS) in Greater China. The company recognized $5.7 million in licensing revenue for Q1 2021 and received approval for the Phase 3 REGAL study in Greece, with patient enrollment planned in France and Germany by Q2. R&D expenses rose to $4.3 million due to increased clinical preparations, while general and administrative expenses reached $3.6 million. The net loss narrowed to $2.4 million, with cash reserves at approximately $28 million.
SELLAS Life Sciences Group (Nasdaq: SLS) will hold a Shareholder Update Call on June 3, 2021, at 8:30 a.m. ET, hosted by President & CEO Angelos Stergiou. The call will provide a corporate update on the company’s progress and future plans in developing cancer immunotherapies.
Participants can join via toll-free numbers or online, with a replay available until June 17, 2021. The company's lead product candidate, galinpepimut-S (GPS), targets the WT1 protein for various cancers, while nelipepimut-S (NPS) aims to treat early-stage HER2+ breast cancer.
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.
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