What Parabilis Medicines, Inc. told the SEC could break it.

Relies on clinical-trial sites in China for significant pre-clinical/clinical data; access and use of that data depends on HGRAC approval, which could impede or delay the program.

“In addition, our ability to access and use clinical trial data for ongoing trials and any new trials conducted in China will be highly dependent on acceptance and approvals from Human Genetic Resources Administration of China (“HGRAC”). There is no guarantee that the HGRAC will not impede our ability to obtain and use clinical trial data for trials conducted in China in a timely manner or in a way that facilitates our use of such data. We intend to rely on our sites in China to provide us with significant data and other information related to our product candidates, including preclinical and clinical data.”

Depends on sole-source and limited-source suppliers (and CDMOs) for drug substances, drug products and raw materials used in its clinical product candidates.

“We depend on sole source and limited source suppliers for certain drug substances, drug products, raw materials, samples, components, and other materials used in our product candidates. If we are unable to source these supplies on a timely basis, or establish longer-term contracts with our suppliers, we will not be able to complete our clinical trials on time and the development of our product candidates may be delayed.”

Potential US tariffs (or Chinese retaliation) on imported active pharmaceutical ingredients used in its product candidates could raise costs or restrict access to raw materials.

“It is possible further tariffs may be imposed that could affect imports of active pharmaceutical ingredients used in our product candidates, or our business may be adversely impacted by retaliatory trade measures taken by China or other countries, including restricted access to such raw materials used in our product candidates.”