Company: RGNX
Filing Date: 2025-06-13
Form Type: S-3
Source: 0001193125-25-140870
Chunk: 4

Company: REGENXBIO Inc.
Filing Date: 2025-06-13
Form: S-3
Chunk 4
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 well as other factors we believe are appropriate under the circumstances. However, whether actual results and developments will conform with our expectations and predictions is subject to a number of risks, uncertainties, assumptions and other important factors, including, but not limited to:

| • |     | our ability to establish and maintain development partnerships, including our collaboration with AbbVie Inc. to                  
 develop and commercialize ABBV-RGX-314 and our collaboration with Nippon Shinyaku Co., Ltd. to develop and commercialize RGX-121 
 and RGX-111;                                                                                                                     |

| • |     | our ability to obtain and maintain regulatory approval of our product candidates, and the labeling for any 
 approved products;                                                                                         |

| • |     | the timing of enrollment, commencement, completion and the success of our AAVIATE®, AFFINITY BEYOND®, AFFINITY DUCHENNE®, ALTITUDE®, ASCENT™, ATMOSPHERE® and 
 CAMPSIITE® clinical trials;                                                                                                                                   |

| • |     | the timing of commencement and completion and the success of preclinical studies conducted by us and our 
 development partners;                                                                                    |

| • |     | the timely development and launch of new products; |

| • |     | the scope, progress, expansion and costs of developing and commercializing our product candidates; |

| • |     | our ability to obtain, maintain and enforce intellectual property protection for our product candidates and 
 technology, and defend against third-party intellectual property-related claims;                            |

| • |     | our expectations regarding the development and commercialization of product candidates currently being developed 
 by third parties that utilize our technology;                                                                    |

| • |     | our anticipated growth strategies; |

| • |     | our expectations regarding competition; |

| • |     | the anticipated trends and challenges in our business and the market in which we operate; |

| • |     | our ability to attract or retain key personnel; |

| • |     | the size and growth of the potential markets for our product candidates and the ability to serve those markets; |

| • |     | the rate and degree of market acceptance of any of our products that are approved; |

| • |     | our expectations regarding our expenses and revenue; |

| • |     | our expectations regarding our need for additional financing and our ability to obtain additional financing; |

| • |     | our expectations regarding the outcome of legal proceedings; |

| • |     | our expectations regarding regulatory developments in