Orchard files for $173M IPO to run pivotal gene therapy trials

If Orchard pulls off the plan, it will close out 2021 with four approved gene therapies. (Nasdaq)

Orchard Therapeutics has filed to raise $173 million (€150 million) in an IPO. The offering will give the GlaxoSmithKline-backed biotech the means to take three gene therapies through the clinic and onto the market.

Transatlantic biotech Orchard established one of the broadest clinical-phase gene therapy pipelines in the industry earlier this year when added GSK’s portfolio to its existing assets. Orchard followed up on the GSK deal with a $150 million series C to support its mushrooming pipeline. And, as hinted at by the involvement of Deerfield Management in the series C, it has now filed to go public.

With Orchard having close to $200 million in cash following the series C, the planned $173 million will put it in a strong position financially. Orchard wants to secure such a war chest to set it up to run pivotal trials of three gene therapies and file for approvals of them on both sides of the Atlantic.

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OTL-101 and OTL-200 look set to be the first two Orchard gene therapies to land on regulators’ desks. Orchard plans to file for FDA approval of OTL-101 in the immune system disorder ADA-SCID in 2020, and seek clearance to sell neurometabolic disorder gene therapy OTL-200 in Europe the same year. A European filing for OTL-101 and U.S. submission for OTL-200 will follow later.

Those two gene therapies are advancing down the pipeline just ahead of OTL-103, a treatment for a rare disease that affects the immune system and platelets. Orchard expects to file for approvals of OTL-103 in the U.S. and Europe in 2021.

Orchard is warning investors that factors including regulatory decisions could set back its plans. The biotech is yet to get definitive feedback on its move from academic to commercial manufacturing. The academic process has caused some problems, with two patients suffering serious adverse events potentially linked to it, but Orchard will need to convince regulators of the comparability of the two production methods. Failure to do so could lead to demands for more clinical data. 

If Orchard pulls off the plan, it will close out 2021 with four approved gene therapies. The fourth, Strimvelis, is an ex-GSK drug that has been on the market in Europe since 2016. Strimvelis had a very slow start commercially and could be superseded by OTL-101, which targets the same indication. The deal with GSK tasks Orchard with keeping Strimvelis on the market until an alternative is available.