VectivBio Holding AG

Welcome to the VictusBio fiscal year 2022 results call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during your session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Patrick Malloy, Senior Vice President, Investor Relations. Please go ahead.

Thank you, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the full year ended December 31st, 2022. Earlier this morning, we issued a press release summarizing our financial results and progress across the company, which is available on our website. I'd like to remind everyone that during today's discussion, we will make statements about our future expectations, plans, and prospects that constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the risk factors discussed in our FCC filings, and we are not under any obligation to update these forward-looking statements. Joining me on today's call are Lucas Santorelli, our Chief Executive Officer, Claudia de Augusta, our Chief Financial Officer, along with Chief Medical Officer Omar Khawaja, and Kevin Harris, our Chief Commercial Officer. Following the prepared remarks, we'll open up the call to a question and answer session. Now, I'd like to turn the call over to Luca Santorelli.

Thank you, Pat, and thanks to everyone for joining us today. For those hearing our story for the first time, VectiBio is a growing, late-stage biopharmaceutical company that is focused on developing potentially life-transforming therapies for people living with serious rare diseases. We are a team of individuals with deep scientific expertise driven by a relentless passion to make a meaningful difference in the lives of people living with rare diseases by developing treatments that are both transformational and tailored to the needs of individual patients. In 2022, we've made tremendous progress in developing a lead molecule, apraglutide, a next-generation GLP-2 analog that bears the promise of unlocking the full potential of the GLP-2 class, thanks to its unique pharmacology and also our patient-tailored development strategy. We believe that apraglutide could transform the lives of people suffering from a broad range of severe, rare gastrointestinal diseases. including short bowel syndrome and intestinal failure, or SBSIF, and acute graft versus source disease, or AGDHD. In 2022, we focused on execution both towards our R&D and corporate goals. And we also positioned ourselves for our next stage of growth. We were able to achieve several key strategic and program milestones despite the challenges that 22 created in the biotech environment. In Q1 2022, we signed a Japan licensing deal with Azaikaze Pharmaceutical, designed to develop and commercialize aproputide in Japan. In Q2, we announced the dosing of the first two patients in targase, our proof of concept study in acute GVHD, currently recruiting across US and Europe. In Q3, we announced promising interim six-month data from the STARS Nutrition Study, a first-of-its-kind study in patients with colon and continuity anatomy, or CSC, which represents an underserved majority of SPS-IF patients. In November, we announced the completion of enrollment for the colon and continuity stratum of the Phase III STARS Pivotal Study. And finally, we strengthen our cash position by raising a total of $284 million via both non-dilutive and equity transactions. The current cash position provides VectiBio with a financial runway into 2025, which is over 12 months after the Phase III results. We believe that 2023 will be a transformational year for VectiBio, with clinical readouts from Stars Nutrition, Stargaze, and the Phase III STARS all over the next several months. More specifically, in early May, six-month data from STARS Nutrition will be presented at an upcoming scientific conference. This study aims to demonstrate that apoglutide can improve intestinal absorption and reduce the need of parenteral support in SBS-IF patients with colon incontinuity. In anatomical subtypes of SBS, where there is limited data supporting the use of GADX. Alongside the progress of the STARS Nutrition Study, the enrollment completion in our Phase III program of apoglutide in SBS-IF is anticipated by the end of this quarter. At this point, we have closed screening of new patients, as those currently under assessment will enable us to reach the enrollment target based on our current screen failure rates. We plan to issue a press release following the randomization of the last patients. Moving on to acute GVSD, I'm happy to announce that we have enrolled all patients necessary to perform the preplanned interim analysis of our Stargaze Phase II program by the end of Q2. These analyses will help us inform the development and filing strategy in acute GVSD, where apragutide has the potential to become the first non-immunosuppressive treatment to address GI damage, which is one of the most critical complications of this disease leading to mortality. A positive stargaze outcome would also establish the rationale to explore the GI healing and regenerative properties of apoglutide in other inflammatory GI conditions, where immunological therapy is currently the main therapeutic approach. Now, I would like to turn the call over to our chief medical officer, Dr. Omar Khawaja, who will share additional details on our pipeline progress. Omar, over to you.