Company: RGNX
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0000950170-25-038770
Chunk: 127

Company: REGENXBIO Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 127
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 of our licensing activities, product development efforts or other operations.

•We have never generated revenue from sales of our product candidates and may never do so in the future.

Risks Related to Third Parties

•If third parties do not meet our deadlines, our preclinical and clinical development programs could be delayed or unsuccessful.

•If our licensing arrangements or collaborations are not successful, our business could be harmed.

Risks Related to Manufacturing

•Products intended for use in gene therapies are novel, complex and difficult to manufacture.

•Delays in obtaining regulatory approval of our manufacturing process or disruptions in our manufacturing process may delay or disrupt our commercialization efforts.

•Third parties we rely upon to conduct our product manufacturing may not perform satisfactorily.

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•We are required to comply with ongoing manufacturing regulatory requirements.

Risks Related to the Commercialization of Our Product Candidates

•If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may be unable to generate any product revenue.

•We may not achieve our projected timelines that we announced.

•Even if we receive regulatory approval, we still may not be able to successfully commercialize our product candidates.

•Failure to obtain or maintain adequate insurance coverage and reimbursement for our products, if approved, or the imposition of price controls or other forms of pricing regulation could limit our ability to market those products and decrease our ability to generate product revenue.

Risks Related to Our Business Operations

•We may not be successful in our efforts to identify or discover additional product candidates.

•Our future success depends on our ability to retain key employees, consultants and advisors and to attract qualified personnel.

•We may face liability for our conduct and that of our employees, principal investigators, consultants or commercial partners.

•We may face product liability lawsuits.

•We could become subject to fines or penalties related to the failure to comply with environmental, health and safety laws.

•We and our collaborators or other contractors or consultants may suffer cybersecurity breaches.

•Our customers are concentrated and therefore the loss of a significant customer may harm our business.

Risks Related to Our Intellectual Property

•Our intellectual property rights may be limited by the terms and conditions of licenses granted to us by others.

•We must obtain and maintain patent protection for our products and technology to protect our intellectual property rights.

•Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.