What Stoke Therapeutics, Inc. told the SEC could break it.

Stoke relies on third-party contractors to manufacture its oligonucleotide drug substance (zorevunersen, STK-002) and has consolidated raw-material procurement and drug-substance manufacturing with a single supplier for its most advanced programs; it only plans to establish alternative-supplier agreements 'as appropriate' to ensure continuity. A production problem, capacity constraint, quality failure, or qualification delay at this single CDMO — compounded for specialized oligonucleotide chemistry and raw materials — could delay clinical supply or future commercial supply. Suppliers unnamed, so a sole-source manufacturing/supplier-concentration risk.

“Many of these contractors are also able to source all the required raw materials, which allows us to consolidate raw material procurement and drug substance manufacturing activities with a single supplier.”

Although clinical-stage with no product revenue, Stoke's materials and production processes are exposed to new U.S. tariffs: a 25% tariff on Canada/Mexico imports (Feb 1, 2025, briefly suspended), a 10% additional China tariff, and an April 2, 2025 baseline 10% tariff on all foreign goods (higher for China and the EU). It also flags ongoing discussion of pharmaceutical-specific tariffs that may impact its supply chain. Tariffs on imported oligonucleotide raw materials/reagents could raise development costs. A cited, quantified trade-policy exposure (bounded by pre-revenue status).

“on February 1, 2025, the U.S. imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China, and on April 2, 2025, the U.S. announced a baseline 10% tariff on all foreign goods, with goods imported from specific nations, including China and those in the European Union, taxed at higher rates.”