Synlogic, Inc.

Good morning. Welcome to Synlogic's fourth quarter and full year 2021 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 that 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 thanks for joining us in today's conference call. This morning, we issued a press release which outlines our fourth quarter and full year 2021 financial results and additional business updates. The release is available on the investor section of our website at www.synlogictx.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 fourth quarter highlights and recent progress, including an update on our lead program in PKU. And Molly will share her perspective on the opportunity to address the medical need and provide a meaningful additional therapeutic option to patients with PKU. Dave will discuss our 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 made 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, Instant Logics Press Release from Earlier Today, and or under the heading Risk Factors in Synlogic's most recent Form 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, Andrew. 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 fourth quarter and full year of 2021. In 2021, the Synlogic team achieved dramatic progress across the portfolio. Proof of concept with our lead program for phenylketonuria, or PKU, and commitment to advance to Phase III initiation this year. Proof of mechanism in enteric hyperoxyluria with SynB8802, a research collaboration with Roche in inflammatory bowel disease, and our second drug candidate for a rare metabolic disease with SYNB1353 for homocystinuria or HCU. We are now advancing a pipeline of clinically differentiated, orally administered drug candidates for metabolic and immune diseases, all based on the advantages of our reproducible proprietary product engine. We are continuing this momentum in 2022, with expected phase three initiation of our PKU program in the second half of this year. CINB 1353 is expected to have healthy volunteer data by year end. And we're also looking forward to proof of concept patient data from our enteric hyperoxaluria program. Given our positive results in September 2021, we were able to complete a successful round of financing We have a strong balance sheet with $136.6 million in cash and equivalents, sufficient to carry us into 2024 and well past this sequence of upcoming milestones. We strengthened the Synlogic team throughout 2021. Today, I'd like to welcome our new CFO, Michael Jensen. Michael brings an impressive financial and operational background from biopharma and healthcare companies, across therapeutic categories and through commercialization, an asset as we progress our programs into late-stage development and through registration. I'd also like to thank Greg Beloff, who has served as our interim CFO during a critical stage for the company. Let's ground ourselves in the vision and breakthrough science that's behind our recent progress. From our inception out of Tim Liu and Jim Collins' lab at MIT, Synlogic was founded on the premise of a new paradigm in biotherapeutics based on the application of synthetic biology to medicine. In just six years, we have created a product engine producing potentially transformative drug candidates based on validated mechanisms for the treatment of metabolic and immune diseases. These synthetic biotics share similar safety profiles due to a lack of systemic absorption or colonization. the convenience of oral delivery, flexible titration, reversibility via rapid GI clearance, and applications across rare and common diseases. I'd like to review our lead program in PKU as we advance into phase three and towards commercialization. A majority of patients with PKU today remain untreated or undertreated due to limitations of current options. in both safety and efficacy. With two FDA-approved drugs, PKU has a de-risk path to registration, with fee reduction used as an acceptable endpoint for full approval, as well as precedence for Phase III study design and related considerations. People with PKU in the US and around the world are diagnosed at birth and treated by a small specialist community presenting an accessible patient population. In September of last year, our phase two proof of concept data showed a potential profile that could meet the PKU community's need for an efficacious, safe oral option, and one that could be used both as monotherapy and adjunctive treatment. We are eager to continue to advance this program forwards towards commercial pivotal studies. I'd like to now hand the call over to Molly to expand upon what makes our approach so potentially meaningful in PKU.