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REGENXBIO (RGNX) 6 Nov 24 2024 Q3 Earnings call transcript

AInvestThursday, Nov 7, 2024 9:42 am ET
1min read

In the latest earnings call, REGENXBIO, a leading gene therapy company, showcased its impressive progress in advancing multiple late-stage programs and preparing for commercialization. The call, led by Curran Simpson, President and CEO, was a testament to the company's strategic focus on driving clinical data and regulatory milestones.

Strategic Clinical Advancements

REGENXBIO's most notable updates revolve around its next-generation gene therapy for Duchenne, RGX-202, and its retinal franchise, RGX-314. In Duchenne, REGENXBIO is set to initiate the pivotal phase of the ongoing AFFINITY DUCHENNE study imminently, making it the only next-generation gene therapy in Phase III study for this devastating disease. The company is also in discussions with the FDA to confirm the accelerated approval pathway remains open, a significant step towards potentially being second to market.

On the retinal front, REGENXBIO is making significant strides with its partner, AbbVie, in developing RGX-314 for both wet AMD and diabetic retinopathy. The company's recent announcements include the accelerated End-of-Phase II meeting for RGX-314 in diabetic retinopathy and the initiation of a global pivotal trial in the first half of 2025. These milestones underscore REGENXBIO's commitment to addressing unmet needs in vision loss prevention.

Financial Outlook and Future Prospects

Financially, REGENXBIO ended Q3 2024 with cash, cash equivalents, and marketable securities of $279 million, a decrease from the previous year. However, the company is confident that this cash runway will fund its operations into 2026, excluding any payment from AbbVie upon the achievement of development or commercial milestones. REGENXBIO's financial outlook is robust, with several catalysts expected in the coming weeks, including the initiation of a pivotal trial for RGX-202, the completion of the End-of-Phase II meeting for RGX-314 in diabetic retinopathy, and the completion of the rolling BLA submission for RGX-121.

Investor and Analyst Questions

During the Q&A session, analysts probed into topics ranging from durability in younger DMD patients to regulatory considerations for RGX-202. REGENXBIO's responses were reassuring, highlighting the company's confidence in its products and strategies. The company also addressed concerns around competition from Eylea biosimilars, emphasizing the differentiation of its products and the value proposition for patients and clinicians.

Conclusion

In summary, REGENXBIO's Q3 2024 earnings call underscored its strategic focus on clinical progress and regulatory milestones. With a robust pipeline of late-stage programs and a strong financial outlook, REGENXBIO is well-positioned to deliver on its promise of transformative treatments for patients in need. As the company moves towards commercialization, investors and stakeholders will be eagerly watching for the realization of these milestones.

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