What INmune Bio, Inc. told the SEC could break it.

A September 2025 proposal for 100% tariffs on imported branded/patented pharmaceuticals (unless the importer builds U.S. manufacturing) could, depending on scope, apply to APIs and bulk drug products used in INmune Bio's clinical trials and raise its materials costs.

“in September 2025, President Trump announced plans to impose 100% tariffs on imported branded or patented pharmaceuticals, unless the importing company is building U.S. manufacturing capacity. It is not yet clear whether these tariffs would apply to the importation of active pharmaceutical ingredients and possibly bulk drug products that are intended for use in clinical trials and not for commercial sale, which could increase the costs of materials for our clinical trials.”

INmune Bio's commercialization depends on FDA and foreign (UK MHRA IRP, EU) approvals of candidates such as CORDStrom and XPro, and on adequate Medicare/Medicaid/commercial reimbursement amid drug-pricing pressure (ACA/IRA, foreign price controls) — significant regulatory hurdles to revenue.

“If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for CORDStrom, we may not be able to commercialize, or may be delayed in commercializing, CORDStrom and our ability to generate revenue could be materially impaired.”

INmune Bio is clinical-stage with no meaningful product revenue (only $50K license revenue in 2025), incurred a $45.9M net loss and ~$22.6M negative operating cash flow, and expects continued losses until/unless it can commercialize its candidates — requiring ongoing financing.

“The Company has incurred significant losses and negative cash flows from operations since inception and expects to incur additional losses until such time that it can generate significant revenue from the commercialization of its product candidates. The Company had net losses of approximately $ 45.9 million and $ 42.1 million and negative cash flows from operating activities of approximately $ 22.6 million and $ 33.4 million for the years ended December 31, 2025 and 2024, respectivel”

INmune Bio relies, and expects to continue relying, on a small number of vendors to manufacture supplies and materials for its clinical-trial programs; a significant interruption in those manufacturing services could adversely affect its trials.

“The Company relies and expects to continue to rely on a small number of vendors to manufacture supplies and materials for its use in the clinical trial programs. These programs could be adversely affected by a significant interruption in these manufacturing services.”