Orchard Therapeutics Ltd. (London, U.K.) proposed to raise up to $172.5 million in an IPO on NASDAQ. J.P. Morgan, Goldman Sachs, Cowen and Wedbush PacGrow are underwriters.
Orchard is developing autologous ex vivo lentiviral gene therapies to treat rare primary immune deficiencies and inherited metabolic disorders. In an April deal with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Orchard gained the pharma’s rare disease gene therapy portfolio, including Strimvelis, which is approved in Europe to treat children with severe combined immunodeficiency due to ADA deficiency (ADA-SCID) (see “Orchard Gains GSK’s Rare Disease Gene Therapy Portfolio”).
According to its prospectus, Orchard paid GSK £10 million ($14.2 million), plus 15.6 million shares, in the deal. If FDA approves any of three therapies Orchard obtained from GSK, Orchard would likely be eligible to receive a Priority Review voucher. The biotech is required to turn over the first voucher to GSK, and GSK would have options to purchase from Orchard any subsequent vouchers.
Orchard has three lentiviral gene therapy candidates in registrational trials: OTL-101 for ADA-SCID; OTL-103 for Wiskott-Aldrich syndrome; and OTL-200 for metachromatic leukodystrophy. It gained OTL-103 and OTL-200 via the GSK deal. Orchard plans to submit a BLA to FDA for OTL-101 in 2020, followed by an MAA to EMA. It intends to submit regulatory applications for OTL-200 to EMA and FDA in 2020; submissions for OTL-103 to both agencies would follow in 2021.
Proceeds from the IPO will also be used to fund commercialization of Strimvelis in the EU, expand marketing and sales operations in the U.S. and Europe, and construct a manufacturing facility. The company estimates proceeds will fund operations through the second half of 2020.
Orchard has raised about $290 million to date. In August, the company announced a $150 million series C round led by Deerfield Management. Baillie Gifford and ORI Capital co-led its series B round in December 2017.
Founding investor F-Prime Capital, which led Orchard’s 2016 series A round, holds a 29% stake. GSK holds 18%, Deerfield holds 7% and Baillie Gifford 6%.