Synlogic, Inc.

Good morning, and welcome to Synlogic's first quarter 2021 conference call. At this time, all participants are enlisted on the mode. 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 Investment 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 first quarter 2021 financial results and additional business updates. The release is available on the investor section of our website at SynlogicTX.com. Joining me on this call are Dr. Aoife Brennan, President and Chief Executive Officer, and Dr. Richard Rees, Chief Medical Officer. Other members of the management team, including Interim CFO Greg Beloff and the full team, will be available during the Q&A. During the call, IFA will provide a review of first quarter highlights and recent progress. Richard will provide an update on our metabolic portfolio and our lead programs in phenylketonuria and enteric hyperoxyluria. And 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 forward-looking statements in Synlogic's press release from earlier today or under the heading Risk Factors in Synlogic's most recent forum 10-K or in later filings with the SEC. Synlogic cautions you not to place undue reliance on any forward-looking statement. Now, I'd like to turn the call over to Aoife.

Thanks, Dan. Good morning, everyone, and thank you for joining us. I'm thrilled to share with you today our financial results from the first quarter of 2021, as well as recent execution and progress across our portfolio. We are 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 and a strengthened balance sheet, we are well positioned to deliver proof of concept readouts for both CINB1618 in PKU and CINB8802 in enteric hyperoxaluria later this year. Since the start of the year, we continue to maintain the rapid pace of which we're developing synthetic biotic medicines with the goal of providing meaningful treatments for patients with serious diseases. We are rapidly progressing our metabolic disease pipeline, which leverages the ability of our platform to engineer synthetic biotic medicines and deliver them safely into the human GI tract to consume a toxic metabolite. We believe that there are a wide variety of disease states where this approach could transform patients' lives. As we plan for late stage clinical development of our co-lead metabolic programs, Synlogic has made the decision to expand our manufacturing footprint by more than 50% to build expanded fermentation and lyophilization capacity. This build-out, which will be completed in the second half of the year, will enable clinical supply to support the potential late-phase development of CINB 1618 and CINB 8802. By building a fully integrated internal process development and manufacturing infrastructure, Synlogic will be able to respond quickly to the needs of our clinical programs and ensure the rapid progress of our pipeline. Completion of the build-out this year sets us up for a rapid transition to late stage development of our metabolic portfolio after potential proof of concept readouts in the second half of 2021. Since our announcement that CINB 8802 has achieved proof of mechanism in humans with dietary hydroxyurea, we now have two metabolic programs, CINB 1618 and PKU, and CINB 8802 in enteric hyperoxaluria that have demonstrated the ability to consume a toxic metabolite within the human gastrointestinal tract. Both programs have done so at levels that have the potential to be clinically meaningful in patients with disease. And in both cases, we have clinical trials ongoing in patients to demonstrate impact on critical endpoints, with a readout expected later this year. With our candidate in PKU, we have previously demonstrated that our lyophilized formulation of CINB1618 was able to consume phenylalanine in the GI tract of healthy volunteers. We are currently evaluating this strain in adult PKU patients in an ongoing Phase II study we call Symphomy 1. This trial continues to enroll well, and we're delighted to see so much patient and investigator-driven interest. We continue to hear from patients and caregivers that a safe oral therapy which reduces plasma fee levels by consuming fee in the GI tract would be a welcome addition to the market. While SYNB 1618 has been progressing in the clinic, SYNB 1934 is also moving through IND enabling activities. SYNB 1934 which was developed using a novel directed evolution approach from CINB 1618, has demonstrated enhanced activity compared to CINB 1618 in preclinical models of feed consumption. We will provide additional updates as this strain progresses towards the clinic. CINB 8802 is our other lead metabolic program. It's 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. We placed healthy volunteers on a high oxalate diet and increased the urinary oxalate levels, thereby inducing dietary hyperoxaluria. and demonstrated robust and dose responsive urinary oxalate reduction relative to placebo. Coming only 15 months after we nominated CINB 8802, these data demonstrate the speed and power of the synthetic biotic platform. We're moving rapidly towards clinical proof of concept in patients with enteric hyperoxaluria. Part B of the phase one study is enrolling well. This study gives us an opportunity this year to demonstrate what very well may be the most clinically attractive profile for patients suffering from enteric hyperoxaluria. We're taking the learnings from our co-lead metabolic programs and applying them to novel approaches to address other inherited and acquired metabolic disorders. Together with our partners at Ginkgo Bioworks, We're advancing our synthetic biotic platform across multiple metabolic disorders and inflammatory conditions such as IBD. We continue to make good progress on this exploratory and preclinical work and will share additional updates over the course of the year. Our immune oncology portfolio also continues to advance. We shared an update on our CINB 1891 program in immune oncology at the recent American Association for Cancer Research annual meeting and continue to enroll both monotherapy and combination therapy arms of the phase one study. Data from both arms will continue to be reported over the course of 2021. Our team has done a tremendous job executing across multiple programs. This resilience and teamwork has allowed us to set the stage for multiple meaningful readouts in 2021. Thanks to our careful capital stewardship and recent financing event, catalyzed by a high-quality syndicate of institutional investors, all milestones occur well within our cash window. In summary, 2021 has already been an incredibly exciting year for the company. We now have demonstrated proof of mechanism in humans from both of our lead metabolic programs, PKU and enteric hydroxyurea. and the opportunity to demonstrate proof of concept in both programs is later this year. Now let me turn the call over to Richard to share progress on the metabolic program. Richard.