REGENXBIO Inc.

Good afternoon, and welcome to the GenX Bio third quarter 2020 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will be given at that time. As a reminder, this conference call is being recorded. I would now like to turn the call over to Mr. Patrick Christmas, Chief Legal Officer for Regenexx Bio. You may begin.

Good afternoon, and thank you for joining us today. With us today are Ken Mills, Regenexx Bio's President and Chief Executive Officer, Dr. Steve Ficola, our Chief Medical Officer, and Vip Vasista, our Chief Financial Officer. Earlier this afternoon, Regenexx Bio released financial and operating results for the third quarter ended September 30th, 2020. The press release reporting our financial results is available on our website at www.regenexxbio.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, Discussion, and Analysis sections of Regenexx Bio's annual report on Form 10-K for the full year ended December 31, 2019, and comparable Risk Factors sections of Regenexx Bio's quarterly reports on Form 10-Q, which are on file with the Securities and Exchange Commission and available on the SEC's website. Any information we provide on this conference call is provided only as of the date of this call, November 4th, 2020, and we undertake no obligation 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 would now like to turn the call over to Ken Mills. Ken?

Thank you, Patrick. Good afternoon, everyone. Thanks for joining us. I hope everyone is staying healthy. On today's conference call, we will provide a recap of our recent progress advancing and expanding our nav technology platform, as well as expected future milestones. Steve will provide an update on our clinical programs, and Vit will provide an update on financial results from the third quarter 2020. We'll then open up the call for questions. I'm proud to say that during this quarter, we've hit several milestones in development of our internal clinical pipeline, as two important Phase II studies evaluating RGX314 when delivered in the suprachoroidal space are now underway for the treatment of wet AMD and diabetic retinopathy. And we've expanded our MPS II program to include additional patients in the ongoing Phase I-II study of RGX121. In addition, our partners at Novartis have recently achieved significant milestone in the gene therapy space with over $1 billion in cumulative net sales of Zolgensma, a transformative one-time gene therapy for the treatment of pediatric patients with spinal muscular atrophy, and the first approved gene therapy based on Regenexx BiosNav technology platform. We're grateful to have contributed to a therapy that's impacted the lives of over 700 children with SMA and their families around the world. As always, we remain focused on the health and safety of our employees, partners, and patients during this challenging COVID-19 pandemic. We continue to actively monitor the impact that pandemic will have on our plans for preclinical and clinical development timelines, and we're focused on our general operations for the remainder of 2020 and into 2021. With that, I'd like to turn the call over to Steve for a more detailed clinical and regulatory update.