Passage Bio, Inc.

Good morning and welcome to the Passage Bio Second Quarter 2022 Financial and Operating Results Conference Call. At this time, all participants are on a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that this call is being recorded at the company's request. Now I'd like to turn the call over to Stuart Henderson, Vice President of Corporate Development and Investor Relations. Stuart, please proceed.

Thank you, Operator. This morning, we issued a press release that outlines the topics we plan to discuss today. This release is available on the Passage Bio website under the Press Releases and Statements section of Investors & News. On today's call, Chip Cahill, Interim Chief Executive Officer, will review our second quarter 2022 and recent business highlights. Mark Forman, our Chief Medical Officer, will review our clinical programs, and Simona King, our Chief Financial Officer, will review our second quarter 2022 financial results. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments on our expectations about timing and execution of anticipated milestones, including the initiation of clinical trials and the availability of clinical data from such trials, our expectations about our collaborators' and partners' ability to execute key initiatives, the ability of our lead product candidates to treat their respective target CNS disorder, manufacturing plans and strategies, trends with respect to financial performance and cash flows, the company's ability to fund research and development programs, impact of the COVID-19 pandemic on the company's operations, and its ability to manage costs along with uses of cash and other matters. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the company's filings with the SEC for information concerning risk factors that could cause its actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. It is now my pleasure to pass the call over to Chip Koehl. Chip?

Thanks, Stuart, and thank you all for joining us this morning. We continue to make important progress advancing our programs and our mission to develop transformative therapies for devastating CNS disorders with limited or no approved treatment options. As we advance our three ongoing clinical programs, we look forward to delivering multiple value-creating clinical milestones in the second half of this year. These milestones build upon several recent accomplishments, including, first, strong momentum in advancing our IMAGINE ONE trial for GM1 gangliosidosis. We have now progressed the study to recruitment of the final cohort, cohort four, in the dose ascending phase of the trial, and we are excited to have begun recruiting patients for this cohort. Second, presentation of encouraging longer-term safety biomarker and clinical efficacy data from cohort one of our IMAGINE ONE trial at the American Society of Gene and Cell Therapy, or ASGCT, annual meeting in May. Mark will review these data in more detail shortly, and we look forward to reporting initial data from cohorts two and three later this year. Finally, FDA clearance of our IND application for a phase one study of PBML-04 in metachromatic leukodystrophy. This marks our fourth consecutive IMD clearance as a company and our third rare pediatric lysosomal storage disorder program to reach clinical development. This clearance is a testament to the strong CMC and analytics capabilities we have developed internally at our state-of-the-art CMC laboratory in New Jersey and the high-quality preclinical data supporting the program through our strong partnership with Penn's gene therapy program. In addition, we continue to recruit additional patients in cohort one of our Galaxy clinical trial for early infantile Krabbe disease and look forward to reporting initial data from a subset of cohort one by year end. Consistent with our current guidance, we also expect to dose the first patient in our UPLIFT-D clinical trial for frontotemporal dementia shortly. Clinical trial execution remains a core priority for us. We have established a global network of trial sites across each of our ongoing clinical programs with active sites in the United States, Brazil, Canada, the UK, Israel, and the Netherlands. We also continue to employ various strategies to drive patient identification across our programs, including several initiatives focused on identifying frontotemporal dementia patients with a granular mutation. These efforts have increased genetic testing among FTD patients over the last few months. Underpinning our execution is a strong cash position, which we estimate will fund our continued operations into the second quarter of 2024. Lastly, we were pleased to have recently added Michael Kamark, PhD, to our board of directors. Dr. Kamark is a seasoned biopharmaceutical executive with over 40 years of experience in discovery research, process development, and technical operations. We look forward to drawing on his expertise. With that, I will now turn it over to our chief medical officer, Mark Foreman, who will review the progress made across each of our ongoing clinical programs.