Q2 2026 Regenxbio Inc Earnings Call Transcript
Key Points
- Completed enrollment in the confirmatory study for RGX-202 ahead of schedule, with over 60 patients in pivotal and confirmatory trials supporting a robust safety data set.
- Received $100 million milestone payment from AbbVie and raised approximately $108 million in a follow-on offering, extending cash runway into Q4 2027.
- FDA confirmed that available data for RGX-121 is sufficient for review under accelerated approval, with no additional studies required for BLA resubmission.
- Long-term data for sura-vec in wet AMD and diabetic retinopathy showed durable efficacy and safety, with over 500 surgeons trained for the procedure.
- Initiated the Phase 2B/3 NAVIGATE study for diabetic retinopathy, expanding the retinal franchise and potential market opportunity.
- US patent on Zolgensma has expired, reducing future royalty revenue from that product in the US.
- Cash runway guidance does not include potential proceeds from additional non-dilutive sources, indicating reliance on future financing events.
- The ex-US AFFINITY RISE study for RGX-202 is not yet initiated, with details on design and regions still undisclosed.
- Top-line data for sura-vec in wet AMD is not expected until Q4 2026, leaving uncertainty in the near term.
- The BLA submission for RGX-202 is a multi-module process, with the clinical module not expected to be complete until Q1 2027, delaying potential approval.
Welcome, everyone, to the second quarter of 2026 REGENXBIO earnings conference call. My name is Elaine, and I will be your conference operator today. (Operator Instructions)
At this time, I'd like to turn the conference over to Patrick Christmas, Chief Legal Officer of REGENXBIO. Please go ahead.
Good morning, and thank you for joining us today. Earlier this morning, REGENXBIO released financial and operating results for the second quarter ended June 30, 2026. The press release is available on our website at www.regenxbio.com. Today's conference call will include forward-looking statements regarding our financial outlook in addition to regulatory and product development plans. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted and can be identified by words such as expect, plan, will, may, anticipate, believe, should, intend,
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