NEW YORK – Orchard Therapeutics on Monday announced the second closing of its securities purchase agreement, which brought in $34 million in funding.
This securities purchase agreement is part of a larger, previously announced financing plan that could bring in up to $188 million at increasing valuations as Orchard's lead gene therapy candidate OTL-200 achieves certain US regulatory milestones. The financing is led by RA Capital Management and includes participation from Deep Track Capital, Cowen Healthcare Investments, Woodline Partners, and Zentree Investments, among others.
The second closing was initiated by Orchard's intention to initiate a biologics license application (BLA) submission for OTL-200 following receipt of minutes from a pre-BLA meeting with the US Food and Drug Administration for the drug. The second closing includes the sale of securities at a purchase price of $8.00 per unit for aggregate proceeds of $34 million. The units comprise 10 ordinary or nonvoting ordinary shares plus one warrant to purchase 11 ordinary or nonvoting ordinary shares.
"The initiation of our BLA submission marks a significant de-risking event for Orchard and our OTL-200 program ahead of a potential US approval in MLD," Orchard Chief Operating Officer Frank Thomas said in a statement. "This next wave of funding from the second closing is expected to provide important capital to support preparations for our anticipated first US launch and advance our next-in-line neurometabolic programs derived from our [hematopoietic stem cell] gene therapy platform."
Orchard, based in London, is developing OTL-200 for the treatment of metachromatic leukodystrophy (MLD), a rare genetic disorder caused by mutations in the arylsulfatase-A (ARSA) gene. OTL-200 is an autologous CD34-positive cell enriched population of hematopoietic stem and progenitor cells that are transduced ex vivo using a lentiviral vector encoding the ARSA gene. The drug, called Libmeldy, was approved in Europe in 2020 for MLD and is currently being studied in a Phase II trial in this disease.
The firm will use the funds to support commercial capabilities for Libmeldy in Europe and to prepare for potential US approval, along with advancing its other pipeline candidates. Orchard expects the financing, along with existing cash, cash equivalents, and investments, will fund operations into mid-2025.
In May, Orchard announced its first pre-BLA meeting with the FDA and that it would begin a rolling submission for OTL-200 for early-onset MLD in the US.