REGENXBIO Inc.

Welcome everyone to the second quarter of 2026 Regenexx BIO Earnings Conference Call. My name is Elaine and I will be your conference operator today. All lines have been placed on mute to prevent any background noise. And after the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star then one, number one on your telephone keyboard. To withdraw your question, press star 1 again. At this time, I'd like to turn the conference over to Patrick Christmas, Chief Legal Officer of Regenexx BIO. Please go ahead.

Good morning, and thank you for joining us today. Earlier this morning, Regenexx BIO released financial and operating results for the second quarter ended June 30, 2026. The press release is available on our website at www.genxbio.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, and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve certain risks and uncertainties. These risks are described in the risk factors and the management's discussion and analysis sections of Regenexx BIO's annual report on Form 10-K for the full year ended December 31st, 2025, and comparable risk factor sections of Regenexx BIO's quarterly reports on Form 10-Q, which will be on file with the Securities and Exchange Commission available on the SEC's website. Any information we provide on this conference call is provided only as the date of this call, August 6, 2026, and we undertake no obligations to update any forward-looking statements we may make on this call on account of new information, future events, or otherwise. Please be advised that today's call is being recorded and webcast. In addition, any unaudited or pro forma financial information that may be provided is preliminary and does not purport to project financial positions or operating results of the company. Actual results may differ materially. I'll now turn the call to Curran Simpson, President and CEO of Regenexx Bio.

Thank you, Patrick, and good morning, everyone. Thank you for joining us today. The second quarter was another period of positive momentum for Regenexx Bio, achieving key milestones across our late-stage pipeline of gene therapies. During the quarter, we announced that we completed enrollment in the confirmatory study for RGX202, reached alignment with FDA on the path to resubmit the BLA for RGX121 and dosed the first patient in the NAVIGATE trial of SuraVac in diabetic retinopathy, achieving a $100 million milestone payment from AbbVie. We have substantially strengthened our financial position through receipt of over $200 million total, inclusive of the AbbVie milestone payment and new capital, Ending the quarter, Proforma with more than $310 million. This extends our runway into Q4 2027, which includes the expected PDUFA date for RGX-202 and brings us closer to our goal of delivering new, needed medicines to patients and generating our first product revenues. Before I turn the call over to Dr. Steve Pakola, our Chief Medical Officer, and Mitch Chan, our Chief Financial Officer, to provide updates on our clinical and financial progress, respectively, I'd like to highlight a few key program updates. Let's start with RGX202, our wholly owned potential best-in-class therapy for Duchenne muscular dystrophy. We believe the top-line pivotal data shared in May further establish RGX2 as a differentiated gene therapy candidate. RGX202 has uniquely demonstrated a large magnitude of effect relative to baseline and strong correlation between microdystrophin expression and functional improvement at one year. This is a comprehensive body of evidence that we believe will support potential accelerated approval. We recently reported that we had fully enrolled and completed dosing in the confirmatory study of RGX202 ahead of schedule. We have enrolled over 60 patients in the pivotal and confirmatory trials to support a robust safety data set in the planned BLA filing. Momentum for RGX202 remains strong. Our strengthened cash position Thank you for joining us today. located in Rockville, Maryland. We remain committed to bringing RGX202 to patients as soon as possible through multiple key milestones, including initiating the XUS-RCT in the first half of 2027 and submitting the first module of the BLA to FDA in Q3 2026 with potential US approval in the second half of 2027. Moving to RGX 121, following our collaborative discussion with FDA in June, where we aligned on a path forward, we have since held a productive Type A meeting with the agency in July. During the meeting, the FDA confirmed that our available data is sufficient for review under the accelerated approval pathway, and no additional studies, including an RCT, will be required for BLA resubmission. The resubmission will include longer-term efficacy and safety data, including participant imaging that we have submitted and continue to compile and analyze as part of our ongoing monitoring requirements. And we are working to resubmit the BLA in Q3. Beyond our rare programs, we continue to make meaningful progress across our retinal franchise through our strategic collaboration with AbbVie. Along with dosing the first patient in the Phase 2b-3 Navigate study for diabetic retinopathy, we and AbbVie recently presented long-term data in both wet AMD and diabetic retinopathy. These studies highlight the durable safety and efficacy profile that underscores our confidence in the potential commercial success of Cirovec. With the NAVIGATE study now underway in diabetic retinopathy, near-term focus of the partnership has shifted to the upcoming pivotal readout for Cerevec in subretinal wet AMD, a milestone that is highly anticipated in the field. We are pleased with the continued momentum across the collaboration and look forward to sharing top-line data from the atmosphere and ascent studies in the fourth quarter. Our focus is clear for the remainder of 2026. Execute against our key milestones and bring hope for transformative gene therapies closer to patients in need. With that, I'll turn it over to Steve.