(Eleison Pharmaceuticals Inc. withdrew its IPO plans in an SEC letter dated June 28, 2023. The cancer biotech filed its S-1  in Jan. 24, 2022. It never filed terms.) 

We are a clinical stage biopharmaceutical company dedicated to acquiring, developing and commercializing late-stage therapies (in Phase II or Phase III trials) to treat rare life-threatening diseases, such as pancreatic cancer, small cell lung cancer, pediatric bone cancer and brain cancer. We were formed in 2009 by Edwin J. Thomas, our CEO and chairman, who through his extensive prior experience as a C-suite executive in several biopharmaceutical companies saw first-hand the need and commercial opportunity for therapies for rare life- threatening diseases with unmet needs.

The Orphan Drug Act defines a “rare disease” as a disease or condition that affects fewer than 200,000 people in the United States. In Europe, Orphan Drug Designations are granted by the EMA, which defines a rare disease as having prevalence of less than 5 per 10,000 people, which is roughly equivalent to the United States standard.

Our current portfolio of drug candidates consists of glufosfamide, inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD). Glufosfamide and ILC are in-licensed and DBD we own outright. Each has received Orphan Drug Designation by the FDA, and glufosfamide and ILC have received Orphan Drug Designation by the EMA as well.  Each of the oncology indications we have targeted are characterized by significant unmet medical needs; that is, indications with a poor prognosis and low five-year survival rates.  Pancreatic cancer, small cell lung cancer, osteosarcoma and brain cancer also have relatively few competitive products in development compared to other cancer types such as breast, prostate, lymphoma and hematological malignancies.

Our lead program, glufosfamide, is in development for pancreatic cancer, the third leading cause of cancer deaths in the United States according to the American Cancer Society. Our ongoing pivotal Phase III study for glufosfamide in second-line pancreatic cancer is expected to be completed in 2024, with an NDA filing with the FDA projected for 2024/25.

Our second program, ILC, is in development for small cell lung cancer and pediatric bone cancer (osteosarcoma). A Phase II trial of ILC for patients with osteosarcoma was completed in 2017. A Phase III trial for patients with lung cancer and a potentially pivotal Phase II/III study of patients with osteosarcoma are expected to commence in 2023 and 2023/24, respectively.

Our newest program, dibromodulcitol, is in development for brain cancer (e.g., glioblastoma), with a pivotal Phase III trial planned to begin in 2023.

We have a limited operating history, have no products approved for commercial sale and have not generated any revenue from product sales, which may make it difficult for investors to evaluate our current business and likelihood of success and viability.  Since in-licensing the glufosfamide program, we have commenced but not yet completed a Phase III trial of glufosfamide for patients with second-line pancreatic cancer.  Since in-licensing the ILC program, we commenced and completed a Phase II trial of ILC for patients with pulmonary metastases of osteosarcoma.  The Company has not yet commenced any new clinical studies of DBD. 

(Note: Eleison Pharmaceuticals filed its S-1 on Jan. 24, 2022, after submitting confidential documents to the SEC on Dec. 13, 2021.)