Synlogic, Inc.

Good morning, and welcome to CineLogic's second quarter 2021 conference call. At this time, all participants are in a listen-only mode. Later, there will be a question and answer session at the end of this call. Please be advised that this call is being recorded. I would now like to turn the call over to Daniel Roseanne, Head of Finance and Investor Relations. Please proceed.

Thank you, Operator. Good morning, and thanks for joining us on today's conference call. This morning we issued a press release which outlines our second quarter 2021 financial results and additional business updates. The release is available on the investor section of our website at SynlogicTX.com. Joining me in this call are Dr. Aoife Brennan, President and Chief Executive Officer, and Dr. David Hava, Chief Scientific Officer. Other members of the management team will also be available during the Q&A. This morning Aoife will provide a review of second quarter highlights and recent progress, Dave will share the latest advancements in applying our synthetic biotic platform to phenylketonuria, and IFA will then return to provide an update on our metabolic portfolio, including enteric hyperoxaluria. Finally, I will summarize our financial results for the quarter. Following our prepared remarks, we will open the call for your 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. then logic cautions you not to place undue reliance on any forward-looking statement. Now, I'd like to turn the call over to Issa.

Thanks, Dan. Good morning, everyone, and thank you for joining us. I'm thrilled to share with you today updates on our recent execution and progress across the portfolio, as well as our financial results from the second quarter of 2021. Before we dive in, and as I'm sure you're already aware, I wanted to first thank Dr. Richard Rees for all of his contributions over the last few years serving as Synlogix Chief Medical Officer. We wish Richard the best in his new endeavors. As our programs continue to build momentum, we remain in good hands with a highly experienced executive team. I'm personally excited to tap into my CMO roots as we initiate a search for a CMO who can lead our growing clinical development organization and shepherd our programs as they transition to later phases of development. Now back to the business. We're executing on our plans to demonstrate the clinical potential of our synthetic biotic platform in 2021. With proof of mechanism established in our two lead metabolic programs, a strengthened balance sheet, and an exciting new partnership, we are well positioned to deliver proof of concept in multiple high-value indications. Like all companies with ongoing clinical studies, we continue to watch the impact of the COVID-19 pandemic and particularly the Delta variant carefully, especially on clinical sites in the southeastern United States. We're pleased that our team continues to execute with the singular goal of developing synthetic biotic medicines which provide meaningful treatments for patients with serious diseases. Let me turn to those programs now. I'll begin with our PKU program. We believe patients living with PKU continue to need additional treatment options to manage this devastating disease, and we believe that an efficacious oral therapy, regardless of genotype, remains one of the most attractive clinical profiles. This is why we've been executing on our plan to evaluate our lead PKU candidate, CINB1618, in a Phase II clinical study we call Symphony. We're thrilled to recently publish the compelling proof-of-mechanism results for our Phase I study of CINB1618 in nature metabolism, and the Symphony study is on track to deliver data later this year. This quarter, we also took another important step forward by initiating the phase one study of CINB 1934. CINB 1934 is an evolved strain of CINB 1618. And in a moment, Dave will tell you more about the science behind our PKU program. Let me tell you why we developed CINB 1934. It's because we never stopped asking the question, how much more efficacy can we deliver for patients? Synthetic biology tools are progressing rapidly, and our team has access to the best of those tools both internally and through our network of collaborators. By deploying a new suite of directed evolution tools to SynB 1618, we were able to generate a candidate which may have even more fee-consuming capacity and move rapidly into the clinic. In enteric hyperoxaluria, we also see a significant opportunity to make a meaningful difference in the lives of patients. CINB 8802, our other lead metabolic program, is designed to consume the toxic metabolite oxalate in the GI tract in patients with enteric hyperoxaluria, a leading cause of oxalate nephropathy and recurrent kidney stones for which there are no approved therapies. As we previously communicated, CINB-8802 has demonstrated the ability to consume oxalate in the GI tract of healthy volunteers, exhibiting a robust and dose-responsive urinary oxalate reduction. We are now evaluating the oxalate-lowering potential of CINB-8802 in a Phase Ib study in patients with enteric hyperoxaluria following Roux-en-Y gastric bypass surgery. This study gives us an opportunity to demonstrate a highly clinically attractive profile. We are taking the learnings from our co-lead metabolic program and applying them to novel approaches to address other diseases in which a GI-based approach may be relevant, including inherited and acquired metabolic disorders, as well as autoimmune conditions. We recently entered into a research collaboration agreement with Roche, for the discovery of a novel synthetic biotic medicine for the treatment of inflammatory bowel disease, or IBD. IBD remains an area of high unmet need in which new approaches are urgently needed. We're delighted to be working with an organization with unparalleled depth in immunology and look forward to exploring the potential of synthetic biotic medicines in IBD. Our team has done a tremendous job executing across multiple programs, during what continues to be trying times for all of us in 2021. This resilience and teamwork have set the stage for multiple meaningful readouts in 2021. Thanks to our careful capital stewardship, these milestones occur well within our cash window. In summary, 2021 has been an incredibly exciting year for the company. We now have demonstrated proof of mechanism in humans from both our lead metabolic programs in PKU and enteric hyperoxyurea. We initiated a phase one study of a next generation strain in our PKU portfolio and initiated an exciting new partnership in immunomodulation. We have the opportunity to demonstrate proof of concept in our co-lead program and advance our mission to bring the transformative power of synthetic biology to medicine. Now, let me turn the call over to Dave to go deeper into our PKU program. Dave?