Enlivex Therapeutics Ltd. (Nasdaq: ENLV), a clinical-stage immunotherapy company, today announced the closing of its previously announced registered direct offering to certain accredited and healthcare-focused institutional investors, including Armistice Capital, of an aggregate of 2,093,750 ordinary shares of the Company and warrants to purchase up to an aggregate of 2,093,750 ordinary shares at a combined purchase price of $8.00 per share and associated warrant, for aggregate gross proceeds of $16.75 million. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
Enlivex intends to use the net proceeds for clinical, regulatory, manufacturing and research and development activities, potential acquisitions and in-licensing, as well as for working capital and other general corporate purposes.
The Enlivex’s current clinical development programs focus on preventing or treating complications associated with hematopoietic stem cell transplants (HSCT), sepsis and solid tumors. Enlivex’s most advanced product candidate, Allocetra™, has been developed for the prevention of complications post HSCT, treatment of patients who do not respond to steroid treatment upon occurrence of graft versus host disease (“ GvHD ”) (“steroid refractory patients”), and prevention of organ damage, or multiple organ failure in sepsis patients. Additionally, Enlivex is currently examining the potential for collaborating with leading CAR-T companies in clinical studies to evaluate the efficacy of immunotherapy treatments in combination with Allocetra™ for treatment of solid tumors.
After completing all pre-clinical safety and efficacy testing in animals, Enlivex began a multi-center Phase IIa clinical trial of Allocetra™ to evaluate the safety, tolerability and preliminary efficacy profile of the drug for the prevention of aGvHD in allogeneic HSCT patients at Hadassah Medical Center, Rambam and Sheba Medical Centers in Israel. Enlivex plans, subject to regulatory approvals, to initiate clinical trials with Allocetra™ for the prevention and treatment of complications post-HSCT in early 2020: (i) Phase II/III for prevention of complications post-HSCT from matched unrelated donors (MURs) pursuant to which the Company currently intends to enroll up to 60 patients; and (ii) Phase II for the treatment of steroid-refractory patients with GvHD post-HSCT pursuant to which the Company currently intends to enroll up to 40 patients, both to be conducted in Israel and the European Union (EU).
Enlivex has initiated a “Prevention of sepsis related organ dysfunction with Allocetra TM (P-SOFA-1)” p Phase Ib clinical trial in the first quarter of 2019 pursuant to which it plans to enroll 10 patients. Upon the successful completion of this study, the Company is planning to initiate a randomized, multi-center, vehicle-controlled, comparative, open-label, study evaluating safety and efficacy of Allocetra™ for the prevention of cytokine storms and organ dysfunction in patients with sepsis.
To prepare for the planned initiation of its clinical trials, the Company has constructed a good manufacturing process (“ GMP ”) manufacturing facility in Israel to support the production of the Allocetra™ drug product for any clinical trial that will be conducted in the EU or Israel.
Enlivex is clinical stage immunotherapy company, developing an allogeneic drug pipeline for immune system rebalancing. Immune system rebalancing is critical for the treatment of life-threatening immune and inflammatory conditions, which involve the hyper-expression of cytokines (Cytokine Release Syndrome) and for which there are no U.S. Food and Drug Administration (“ FDA ”)-approved treatments, as well as treating solid tumors via modulating immune-checkpoint rebalancing. Enlivex’s innovative immunotherapy candidate, Allocetra™, is a novel immunotherapy candidate based on a unique mechanism of action that targets clinical indications that are defined as “unmet medical needs” such as preventing or treating complications associated with bone marrow transplants (“ BMT ”) and/or hematopoietic stem cell transplants (“ HSCT ”), sepsis and acute multiple organ failure. Enlivex also intends to develop its cell-based therapy to be combined with effective treatments of solid tumors via immune checkpoint rebalancing to increase the efficacy of various anti-cancer therapies, including Chimeric Antigen Receptor T-Cell Therapy (“ CAR-T ”) and therapies targeting T-Cell Receptor Therapy (“ TCR ”).
For more information, visit http://www.enlivex.com.