EpiCept expects to receive approximately $4.3 million in net proceeds from a registered direct offering with an institutional investor. Net proceeds from the offering will be used to meet working capital needs and for general corporate purposes.
The agreement covers the purchase of approximately 7.1 million shares of its common stock at $0.65 per share and five and a half year warrants to purchase up to approximately 5.3 million shares of common stock at an exercise price of $0.72 per share. The warrants will not be exercisable for six months following the closing date of the offering, which is expected on or about March 31.
EpiCept is focused on the development and commercialization of pharmaceuticals for the treatment of cancer and pain. The company’s Ceplene® is approved in the EU and several other countries for the remission maintenance and prevention of relapse in adult patients with acute myeloid leukemia in first remission. In the U.S. a pivotal trial is scheduled to commence this year.
Last year the FDA sent EpiCept a refuse to file letter, stating that it wasn’t convinced of Ceplene’s therapeutic contribution in its combination with IL-2. EpiCept and the agency have now reportedly reached an agreement on these issues, and the firm will conduct a two-arm, randomized, open-label trial. The study will compare the efficacy of Ceplene plus low-dose IL-2 to standard of care with overall patient survival as the primary endpoint.
EpiCept has two other oncology candidates currently in clinical development. Both were discovered in-house and have been shown to act as vascular disruption agents in a variety of solid tumors, says the firm.
EpiCept’s pain portfolio includes EpiCept™ NP-1, a prescription topical analgesic cream in late-stage development. It is designed to provide effective long-term relief of pain associated with peripheral neuropathies.