Orchard Therapeutics, a commercial-stage biopharmaceutical company, announced financial results for the quarter ended March 31, 2019 and provided several program updates related to its neurometabolic disease portfolio. Orchard has brought forward the timeline for key clinical and regulatory milestones for two of its neurometabolic disease programs and has secured an exclusive worldwide license for a clinical-stage ex vivo autologous hematopoietic stem cell (HSC) gene therapy program in Mucopolysaccharidosis Type I (MPS-I).
"The progress we've made advancing ex vivo autologous hematopoietic stem cell-based gene therapies aimed at correcting neurometabolic diseases furthers our confidence in the potential of our technology to treat additional serious, often fatal, rare diseases that to date have been difficult or impossible to treat," said Mark Rothera, president and chief executive officer of Orchard. "With today's announcements, including the addition of the MPS-I program, our gene therapy portfolio now includes nine programs from late pre-clinical to commercial stage, with the goal of having three more approved therapies available to transform the lives of children affected by some of these serious rare diseases in the next three years."
Orchard signed a five-year senior credit facility for up to $75 million with MidCap Financial. Twenty-five million dollars of the facility is to be funded on or around May 28, 2019, with the ability to access the remaining $50 million in two tranches subject to the achievement of certain clinical and regulatory milestones and other customary conditions. The facility provides for an interest-only period of up to 36 months and bears interest at a rate of LIBOR plus 6%.
The company expects that its cash and investments as of March 31, 2019, together with the borrowing capacity from the senior credit facility with MidCap Financial, will fund its anticipated operating and capital expenditure requirements into 2021.
"The MPS-I program is a significant and important addition to our portfolio, enabling us to leverage our expertise in neurometabolic diseases and further extend the potential reach in addressing these conditions," said Frank Thomas, chief financial officer and chief business officer of Orchard. "The $75 million credit facility strengthens our cash position and supports a number of important milestones, with a particular focus on the build-out of an Orchard manufacturing site. In addition, we continue to prepare for three potential product launches and the completion of two registrational trials and three proof-of-concept trials as part of our broader mission to bring gene therapy treatments to patients who need them."