Company: IMRX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001790340-25-000104
Chunk: 194

Company: Immuneering Corp
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 4
Chunk 194
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 but our future business strategy incorporates potential international expansion, for example upon the possible addition of international clinical trial sites, potential engagement with a collaborator based internationally, or if any of our product candidates receives regulatory approval. Doing business internationally involves a number of risks, including but not limited to:

•  multiple, conflicting and changing laws and regulations, such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

•  failure by us to obtain and maintain regulatory approvals for the use of our product candidates in various countries;

•  additional potentially relevant third-party patent rights;

• complexities and difficulties in obtaining intellectual property protection and enforcing our intellectual property rights;

•  difficulties in staffing and managing foreign operations;

•  complexities associated with managing multiple payor reimbursement regimes, government payors or patient self-pay systems;

•  limits in our ability to penetrate international markets;

• financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our product candidates and exposure to foreign currency exchange rate fluctuations;

•  natural disasters, political and economic instability including wars, terrorism and political unrest (for example, the ongoing conflict between Russia and Ukraine, as well as in the Middle East), outbreak of disease (for example, COVID-19 and other pandemics), boycotts, curtailment of trade and other business restrictions;

•  increased susceptibility to trade disputes between nations, including from the imposition of tariffs, which may adversely impact operations (such as conducting ex-U.S. clinical trials or sourcing materials internationally);

•  certain expenses including, among others, expenses for travel, translation and insurance; and

•  regulatory and compliance risks that relate to maintaining accurate information and control over sales (if any) and activities that may fall within the purview of the FCPA, its books and records provisions, its anti-bribery provisions or other anti-bribery and anti-corruption laws.

Any of these factors, among others, could significantly limit or harm our future international expansion and operations and, consequently, our results of operations.

Acquisitions, joint ventures or other transactions involving third parties could disrupt our business, cause dilution to our stockholders and otherwise harm our business.

We have in the past and may in the future acquire other businesses, products or technologies as well as pursue strategic alliances, joint ventures, licensing arrangements, supply agreements or investments in complementary businesses. We have limited or in some cases no experience in completing such