Synlogic, Inc.

Good morning. Welcome to Synlogic's third quarter 2021 conference call. At this time, all participants are in a listen-only mode. There will be a question and answer section at the end of this call. Please be advised this call is being recorded. I would now like to hand 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 third quarter 2021 financial results and additional business updates. The release is available on the investor section of our website at SynlogicTX.com. Joining me this morning are Dr. Aoife Brennan, President and Chief Executive Officer, and Molly Harper, our newly appointed Chief Business Officer. Other members of the management team will be available during the Q&A. During the call, Aoife will provide a review of third quarter highlights and recent progress, including an update on our program in phenylketonuria, and Molly will share her perspective on the unmet need in PKU and the opportunity to impact patients. IFO will then return to provide an update on our metabolic portfolio. 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, uncertainties, which may 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. So, logic cautions you not to place undue reliance on any forward-looking statement. And now, I'd like to turn the call over to Eva.

Thanks, Dan. Good morning, everyone, and thank you for joining us. I'm thrilled to share with you today updates on our recent progress as well as our financial results from the third quarter of 2021. When we began 2021, we set out to prove the clinical potential of our synthetic biotic platform. We had the opportunity to demonstrate proof of concept in phenylketonuria in our Phase II symphony study, and we're thrilled to report that we've done just that. Our lead asset, SynB1618, demonstrated a robust and statistically significant reduction in plasma C-levels and clear alignment across a multitude of study endpoints. This is the first time in the history of PKU drug development that a therapeutic that is delivered and acts locally in the GI tract has had an impact on systemic fee levels. Furthermore, we believe our evolved synthetic biotic strain, SYNB1934, may demonstrate even more fee lowering activity. This is also the first example of a biotherapeutic generated by the synthetic biotic platform demonstrating robust proof of concept in a disease population. But we do not intend to stop at PKU. We're building a robust portfolio with significant progress over the past quarter in multiple metabolic indications. In enteric hyperoxaluria, as we shared at the American Society of Nephrology Kidney Week, our product candidate, SYNB 8802, has demonstrated robust consumption of oxalate in the GI tract, as measured by both urinary and fecal oxalate reduction. SYNB 8802 has the potential to be a meaningful therapy for patients suffering from enteric hyperoxaluria who face as we also reported at Kidney Week, a substantially increased risk of incident chronic kidney disease as a result of the insidious damage oxalate does to renal function over time. We continue to prosecute the proof of concept study of CINB 8802 in patients and will report on that data in 2022. We're also proud to have unveiled this week with our partners at Ginkgo Bioworks, our third oral metabolic program, which we call CINB1353. CINB1353 degrades methionine in the GI tract for the treatment of homocystinuria, or HCU. HCU is an inborn error of metabolism and a natural extension of our work in PKU, We'll be speaking more about this program as we prepare for and file an IND and advance into the clinic next year. Our immunology pipeline, while more nascent, also continues to advance. We're excited that our collaboration with Roche is to develop a synthetic biotic medicine for the treatment of IBD is off to a fast start with the first milestone already achieved. And we have also completed enrollment in the combination arm of a Phase I all-comers immuno-oncology study of CINB1891 with anti-PD1L1. We look forward to sharing data on that study at CICCI later this week. In order to focus our resources on our oral programs, however, we will not be continuing further studies of CINB1891 at this time. Synlogic today is well positioned to deliver on the promise of our platform and bring a meaningful new therapeutic approach to patients. We are executing on our strategy, focusing on rare and niche metabolic diseases where a targeted approach restricted to the GI tract can treat patients in ways other modalities cannot. Now, let me welcome Molly Harper to the team and give her a few moments to share her thoughts on the unmet need in PKU. Molly comes to us with a wealth of pre-commercial launch experience in both broad and rare diseases in the United States and globally. And we are thrilled to have her build our capabilities as we look to pivotal development in PKU. Molly, over to you.