Company: RGNX
Filing Date: 2025-03-13
Form Type: POSASR
Source: 0001193125-25-053917
Chunk: 4

Company: REGENXBIO Inc.
Filing Date: 2025-03-13
Form: POSASR
Chunk 4
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 and maintain development partnerships, including our collaboration with AbbVie to                          
 develop and commercialist ABBV-RGX-314 and our collaboration with Nippon Shinyaku 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 out ability to obtain additional financing; |

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

| • |     | our expectations regarding recent regulatory developments in the United States and foreign countries; and |

ii

| • |     | changes in the financial markets and banking system that may affect the ability and terms on which we may obtain                                    
 financing and our ability to accurately predict how long our existing cash resources will be sufficient to fund our anticipated operating expenses. |

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