Business
SELLAS Life Sciences Provides Business Update and Reports Third Quarter 2020 Financial Results
- Received IMPD Approval to Commence Enrollment in France for Pivotal Phase 3 Study of Galinpepimut-S in Acute Myeloid Leukemia Patients - - Strengthened
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"- Received IMPD Approval to Commence Enrollment in France for Pivotal Phase 3 Study of Galinpepimut-S in Acute Myeloid Leukemia Patients -\n - Strengthened Balance Sheet During Quarter with $9.2 Million Financing - NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today provided a business update and reported financial results for the quarter ended September 30, 2020. “In the third quarter, we announced an important milestone for our Phase 3 REGAL study of galinpepimut-S (GPS) in acute myeloid leukemia (AML) when we received approval from the French regulatory authorities for our Investigational Medicinal Product Dossier (IMPD), which allows SELLAS to commence patient enrollment for the REGAL study in France,” said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We also strengthened our balance sheet during the quarter with a $9.2 million private placement of shares and warrants priced at-the-market. We are using the proceeds from the financing to continue to progress our ongoing GPS studies, as the Company moves closer to the multiple data readouts that are expected over the next 18 months, including the initial data review of our mesothelioma study by year end.” Pipeline Highlights Galinpepimut-S (GPS) In September 2020, SELLAS announced the approval of its Investigational Medicinal Product Dossier (IMPD) from Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), the French regulatory authority, to advance the enrollment in France for the Phase 3 REGAL study of GPS in patients with AML who have achieved complete remission after second-line anti-leukemic therapy (CR2). Nelipepimut-S Finalized data from the National Cancer Institute-sponsored Phase 2 randomized trial of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal. The VADIS study will be presented in a Spotlight Poster-Discussion Session, PD11-09, at the 2020 San Antonio Breast Cancer Sympo...