Synlogic, Inc.

Good morning, and welcome to Synlogic's first quarter 2022 conference call. At this time, all participants are in a listen-only mode. There will be a question and answer session at the end of this call. Please be advised this call is being recorded. I would now like to turn the call over to Andrew Funderburg of Kendall Investor Relations. Please proceed.

Thank you, operator. Good morning, and thank you for joining us on today's conference call. This morning, we issued a press release which outlines our first quarter 2022 financial results and additional business updates. The release is available on the investor section of our website at www.simlogictx.com. Joining me on this call are Dr. Aoife Brennan, President and Chief Executive Officer, Molly Harper, Chief Business Officer, Dave Hava, Chief Scientific Officer, and Michael Jensen, Chief Financial Officer. Other members of the management team will be available during the Q&A. During the call, Aoife will provide a review of first quarter highlights and recent progress, including an update on our lead program in PKU, and Molly will share her perspective on the PKU opportunity. Dave will discuss her earlier stage programs and collaborations, and Michael will provide a financial overview. Following our prepared remarks, we will open the call for questions. As we begin, I'd like to remind everyone that comments today may include forward-looking statements made under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date hereof and are subject to numerous factors, assumptions, risks, and uncertainties, which change over time. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including those described under the heading Forward-Looking Statements in Synlogic's press release from earlier today or under the heading Risk Factors in Synlogic's most recent Form 10-K or in later filings with the SEC. Synlogic constitutes not to place undue reliance on any forward-looking statement. Now, I'd like to turn the call over to Aoife.

Thanks, Andrew. Good morning, everyone, and thank you for joining us. I'm happy to share with you today updates on our recent progress as well as our financial results from the first quarter of 2022. We've had a busy first quarter with significant progress. Michael Jensen joined us as Chief Financial Officer, bringing an impressive financial and operational background from biopharma and healthcare companies across therapeutic categories and through commercialization. This quarter also included a return to in-person presentations at scientific congresses. In the month of May, our congress presentations cover preclinical and clinical program data, as well as platform analytics from our manufacturing team, highlighting Synlogix's achievements across multiple domains. Looking ahead, while our Phase II program in PKU progresses, We, like others in the industry, have been affected by persistent and broad-based factors, most notably labor shortages impacting our clinical trial sites. For us, these challenges increased in parallel with implementation of the second arm of the symphony study for SYNB 1934. Given this, today's press release updated timelines for our PKU programs. with Phase II data now expected in the second half of this year and Phase III initiation in the first half of 2023. The milestones for HCU and enteric hyperoxaluria programs remain unchanged, with expected proof of concept in enteric hyperoxaluria and healthy volunteer days in HCU in the second half of 2022. Importantly, these PKU program updates do not reflect challenges with patient interest or trial competition. It has been the opposite. The more we engage with KOLs, clinicians and the PKU patient community, the more excited we are about the importance of and demand for a new treatment option and what our potential product profile could mean. As a disease, PKU presents both a significant medical need for a new treatment option and a relatively de-risked path from a regulatory and commercial perspective. Despite being a devastating disease with multiple FDA-approved treatments, a large majority, over 75% of patients with PKU today remain untreated or undertreated due to limitations of current options, both in safety and efficacy. At the same time, having two FDA-approved drugs provides us with regulatory precedents that are helpful and unusual in rare disease drug development. These precedents include a path to full approval based on the biochemical primary endpoint of plasma B reduction. They also provide precedents of approval based on one registrational study and without an advisory committee. These approved drugs also provide examples of Phase III study designs and related considerations that led to FDA and EMA approvals. Our interim Phase II proof-of-concept data last year showed a potential profile that is differentiated and well-suited for the patients who need a new option. A potentially efficacious, safe oral treatment that could be used as either monotherapy or as an adjunct to CUVAN or sepraterin. We look forward to providing an update on our phase two results in the second half of this year as we advance this program forward towards phase three and ultimately registration. I'd like to now hand the call over to Molly to expand upon our path to bringing the PKU program through to patients.