Company: RGNX
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0000950170-25-038770
Chunk: 128

Company: REGENXBIO Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 128
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•Our intellectual property licenses with third parties may be subject to disagreements.

•We are required to comply with the agreements under which we license intellectual property rights from third parties.

•We may not be successful in obtaining necessary rights to our product candidates through acquisitions and in-licenses.

•We may not be able to protect our intellectual property rights in the United States and throughout the world.

•Issued patents covering our NAV Technology Platform or our product candidates could be found invalid or unenforceable.

•Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights.

•We may be subject to intellectual property claims.

•Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

•We may be unable to obtain patent term extension and data exclusivity for our product candidates.

Risks Related to Ownership of Our Common Stock

•Our operating results are difficult to predict and could cause the price of our common stock to fluctuate substantially.

•Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights.

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•Strategic partnerships and any other arrangements or acquisitions that we effect in the future may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.

•Provisions in our certificate of incorporation and bylaws might discourage, delay or prevent a change in control.

•Our certificate of incorporation includes exclusive forum clauses for certain litigation.

•Our business could be negatively affected as a result of the actions of activist stockholders.

Risks Related to our NAV Technology Platform and the Development of Our Product Candidates

Our gene therapy product candidates are based on a novel technology that makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval. Only a few gene therapy products have been approved in the United States, the European Union or elsewhere.

We have concentrated our research and development efforts on our proprietary AAV gene delivery platform (our NAV Technology Platform), and we have granted licenses to certain intellectual property related to our NAV Technology Platform to our NAV Technology Licensees. Our future success depends on our and our NAV Technology Licensees’ successful development and commercialization of viable gene therapy product candidates. There can be no assurance that we or our NAV Technology Licensees will not experience problems or delays in developing current or future product candidates or that such problems or delays will not cause unanticipated costs, or that any such development problems can