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 Balance Sheet During Quarter with $9.2 million Financing -
NEW YORK, November 13, 2020 -- 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 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."
•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).
•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 Symposium, December 8-12, 2020:
Session Date – Time: Friday, December 11, 2020: 2:15 pm – 3:30 pm
•In August 2020, SELLAS received gross proceeds of approximately $9.2 million from a private placement financing with certain institutional and accredited investors.
Third Quarter 2020 Financial Results
R&D Expenses: Research and development expenses were $2.4 million for the third quarter of 2020, as compared to $1.8 million for the third quarter of 2019. Research and development expenses for the nine months ended September 30, 2020 were $6.5 million, as compared to $5.0 million for the same period in 2019. The increases in research and development expenses during the third quarter and the nine months ended September 30, 2020 compared to the same periods in 2019 were primarily due to clinical trial expenses incurred for the REGAL study commencing in 2020.
The following information was filed by Sellas Life Sciences Group, Inc. (SLS) on Friday, November 13, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.