What Neurogene Inc. told the SEC could break it.

Neurogene's gene-therapy production requires highly specific raw materials, cells and reagents from limited suppliers, and one or more suppliers is the sole source of certain materials — a disruption could halt clinical-supply manufacturing.

“One or more of our suppliers is the sole source of certain materials used by us in our manufacturing process, and a disruption of the supply of those materials could also negatively impact our ability to manufacture clinical supply as we would have to suspend or revise our operations to accommodate for any disruption in the supply of those materials.”

All cGMP manufacturing is at a single ~42,000 sq ft facility in Houston, Texas, which is subject to hurricanes and severe storms that could interrupt utilities, damage the facility, and halt production.

“Our manufacturing facility is located in Houston, Texas, which is subject to extreme weather events such as hurricanes and other significant storms, which can cause interruption to our utilities and potentially result in damage to our facility”

Neurogene has no product revenue and significant, continuing operating losses and negative cash flow as it advances clinical development, making it dependent on raising additional capital.

“Since inception, we have not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from our operations. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates.”

Proposed U.S. tariffs of up to 100% on imported branded/patented pharmaceuticals (and higher duties on China/India APIs) could raise costs of clinical-trial materials and disrupt the biopharma supply chain.

“In September 2025, the United States announced plans to impose up to 100% tariffs on imported branded or patented pharmaceuticals, subject to certain exceptions (the “Pharmaceutical Tariffs”). If the Pharmaceutical Tariffs are implemented, we may face increased costs and administrative burdens.”