What Zenas BioPharma, Inc. told the SEC could break it.

The company's sole CMO and collaboration supplier both manufacture from facilities in China, concentrating all clinical drug supply in one country.

“many of our suppliers primarily operate outside of the U.S., including our current sole CMO for obexelimab, WuXi Biologics, and our collaboration partner InnoCare for supply of orelabrutinib, which provide services to us from facilities located in China, and increases in tariffs could result in increased costs.”

Indebtedness under the Pharmakon Loan Agreement, combined with no product revenue expected until 2027 at the earliest and a $765.1M accumulated deficit, pressures financial condition.

“Our indebtedness resulting from our Loan Agreement with Pharmakon or future indebtedness could adversely affect our financial co”

Drug substance, drug product and components imported from China are subject to existing tariffs and may be hit by additional tariffs, raising costs.

“currently we import from China certain drug substance, drug product and other components, and such imports are subject to existing tariffs and may be impacted by additional tariffs.”

Zenas owns no manufacturing and relies on single third-party manufacturers (WuXi Biologics for obexelimab, InnoCare for orelabrutinib) with no redundant drug-substance/drug-product supply.

“we currently rely on single third-party manufacturers, WuXi Biologics for supply of obexelimab, and our collaboration partner, InnoCare for supply of orelabrutinib, both of which are located in China, to manufacture and supply the drug substances and drug products for our product candidates, and we currently do not have any redundant supply outside of WuXi Biologics, and InnoCare, for drug substance and drug product.”