Voyager Therapeutics, Inc.

Good afternoon and welcome to the Voyager Therapeutics fourth quarter and full year 2020 financial results conference call. At this time, all participants are in a listen-only mode. This call is being webcast live on the investor and media section of Voyager's website at voyagertherapeutics.com. This call is property of Voyager Therapeutics and recording, reproduction, or transmission of this call without the express written consent of Voyager Therapeutics is strictly prohibited. Please be advised that this call is being recorded. I would now like to introduce Alison Dorval, CFO at Voyager.

Good afternoon, and thank you for joining us. With me on the call today are Andre Tarrant, our President and Chief Executive Officer, and Omar Khwaja, Chief Medical Officer and Head of R&D. This afternoon, after market closed, we issued a press release which outlines the financial results and corporate highlights for the fourth quarter and full year 2020. The release is available at voyagertherapeutics.com. Before we begin, just a reminder that the forward-looking statements included in this call represent the company's view as of today, February 25th, 2021. Voyager disclaims any obligation to update these statements to reflect future events or circumstances, except as required by law. Please refer to today's press release, as well as Voyager's filing with the SEC, for information concerning risk factors that could cause actual results to differ materially from those expressed or implied by such statements. With that, I'll turn the call over to Andre.

Great. Thank you, Alison, and good afternoon, everyone. Welcome to our Q4 earnings and corporate update call. I'll begin by walking through highlights from 2020 and expectations for 2021. Omar will discuss our pipeline programs and plans, and Allison will close with our financial results and guidance. Once we've concluded our remarks, we'll take questions in the Q&A session. In 2020, we remained focused on moving our pipeline and our key platform activities forward. Among the key highlights, we made significant progress in readying our Huntington's disease program for clinical trials. Based on our preclinical data, we believe that the VYHTTO1 has the potential to be a best-in-class therapy for this devastating disease. We achieved highly promising results using our tracer platform to identify capsids with a much better ability to cross the blood-brain barrier than current serotypes. The implication of these advances could be profound for both our own pipeline and for the field of gene therapy through collaborations. We also advanced our overall pipeline and platform and provided updates on the progress through 18 presentations at scientific conferences and four publications in peer-reviewed journals. And finally, we made key additions to our team at the board level, at the SAB level, and also at the senior management level. While we made very good progress, the past year wasn't without its challenges. Our Huntington's IND was placed on clinical hold pending resolution of additional device and CMC-related requests from the FDA. The Parkinson's IND was also placed on clinical hold, in that case pending follow-up imaging and clinical assessments requested by the DSMD. and a risk-benefit assessment requested by the FDA. And NERCLIN recently notified us of its intent to terminate the portion of our collaboration related to the VYADC program. The work we do is challenging, but the potential rewards for patients and their families are enormous. Voyager was founded on a commitment to applying gene therapy to some of the most life-limiting and disabling disorders in medicine and our resolve is unwavering. We've built a world-class team of experts at the intersection of gene therapy and neuroscience. On the back of the pioneering work we've done to date and our most recent advances, we're now poised to enter a new phase in our mission to deliver transformative therapies for people suffering from severe neurological diseases. Before I turn it over to Omar, I'd like to point out some of our upcoming highlights for 2021. For the Huntington's program, we expect to provide our response to the FDA on our IMD in the first half of the year and to initiate our first in-human trial upon IMD acceptance. For the novel capsids, we plan to present non-human primate data on our lead capsids at a scientific conference in the first half of 2021. For the Parkinson's program, we expect to provide an update on the potential path forward based on the additional information being collected by NERCRM in response to the FMV request. And lastly, for the preclinical pipeline, including our innovative vectorized antibodies, we expect to announce new programs and provide updates at scientific meeting and other presentations in the first half of the year. With that, I'll turn the call over to Omar.