What Immunome, Inc. told the SEC could break it.

Sole-source dependency

• No internal manufacturing; reliance on sole-source CDMOs/CROs — acutely the scarce pool of suppliers qualified to handle radioactive materialmedium

  Immunome owns no manufacturing facilities and depends on third parties for the manufacture, supply and testing of its preclinical, clinical and (future) commercial materials — some of which may be sole-source vendors. While it intends to avoid sole-source arrangements, it says that is not always possible, and it faces a particularly acute constraint for programs involving radioactive material: there is only a limited number of CROs and clinical manufacturing organizations qualified to work with radioactive material, which can force sole-source relationships and has already caused delays in acquiring required supplies. A disruption, capacity limit, or quality issue at a sole-source (especially radioactive-material-qualified) vendor could delay its clinical programs and, eventually, commercial supply. Vendors are unnamed, so this registers as a high-importance sole-source/limited-supplier risk.

  “due to the limited number of suppliers qualified to work with radioactive material, or we may develop sole-source relationships with vendors, which may present additional risks inherent to a sole-source relationship”

  SEC filing →As of 2026