Fractyl Health, Inc.

Good afternoon and welcome to Fractal Health's first quarter financial results and business updates call. As a reminder, this conference call is being recorded. At this time, all participants are in a listen-only mode. There will be a Q&A session following management's prepared remarks. I will now turn the call over to Stephen Jasper. Stephen, you may now begin.

Thank you. This afternoon, we issued a press release that outlines the topics we plan to discuss today. This release is available at www.fractal.com under the Investors tab. Today on our call, Dr. Harith Rajagopalan, Chief Executive Officer, Lisa Davidson, Chief Financial Officer, Dr. Timothy Kiefer, Chief Scientific Officer, and Adrienne Kimber, Chief Commercial Officer, will review our recent business highlights and first quarter financial results. Before we begin, I would like to remind everyone that statements made during this conference call that do not relate to matters of historical fact, including statements about our objectives and anticipated clinical milestones, preclinical or clinical trial data, the impact of any of our product candidates, the design, initiation, timing, and results of clinical enrollment and any clinical trial or readouts, the potential launch or commercialization of any of our product candidates or products, and the sufficiency of our cash cash equivalents, and investments to fund our operating activities for any specific period of time should be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are intended to be subject to the safe harbor protection provided by the Reform Act. Actual results could differ materially from those indicated by the forward-looking statements due to the impact of risk, uncertainties, and other important factors. Participants are directed to the risk factors set forth in Fractal's quarterly report on Form 10-Q for the period ended March 31, 2024, and accompanies other filings with the Securities and Exchange Commission. Any forward-looking statements made today speak only to Fractal's operations as of today. Fractal disclaims any duty to provide updates to its forward-looking statements, even if subsequent events cause the company's views to change. It is now my pleasure to pass the call over to Harit.

Thank you, Stephen, and good afternoon, everyone. Thank you for joining us for our first quarterly results call. Over 10 years ago, I co-founded Fractal with a singular and audacious goal, to eradicate metabolic disease. As a physician, I saw firsthand how type 2 diabetes and obesity and their comorbidities impact patients and their families. I witnessed patients experience complications of disease despite following all of their doctor's advice, spouses becoming caregivers, and children losing parents far too young to diseases that should be entirely treatable. I knew that there had to be a better way to address these issues by tackling the diseases at their root cause, in the gut and in the pancreas, and thus Fractal Health was born. We have always been clear with our vision to develop transformative therapies that can prevent and eliminate metabolic disease. We have never wavered in our focus. because we knew that treating the underlying disease is the most patient-centered approach to better long-term health. I am pleased to be here today to present these results because we are so close to achieving the goals we set forth for ourselves a decade ago. 2024 is shaping up to be a pivotal year for Fractal. We are executing on our strategy, we are clear about the future, and we are ready to bring Fractal to the next level to help even more patients around the world. The treatment landscape for metabolic disease has radically changed over these last several years with the emergence of GLP-1 drugs. These therapies are incredibly effective and exciting developments, but they also have significant limitations. Their need for chronic administration, their high discontinuation rates, and the dramatic weight regain and loss of metabolic benefits observed as soon as people stop treatment. To address this unmet need, we are developing transformative therapies that precisely target and alter the function of the diseased organs that are responsible for the development of obesity and type 2 diabetes. In a world with potent drugs that still do not eliminate disease, we believe the clinical and economic value proposition is shifting now from chronic disease management to the prevention and remission of underlying disease. Our two platforms, Revita and Rejuva, target dysfunction in the duodenum and pancreas, respectively, and are designed to provide long-term metabolic benefits from a single administration. Our Revita platform is a proprietary device and delivery system that targets the duodenum to reverse pathology in the duodenal lining that is a root cause of obesity and type 2 diabetes. Revita uses heat energy to ablate dysfunctional duodenal mucosa to enable the regeneration and renewal of the duodenum and restore normal metabolic signaling from the gut. The procedure takes less than 45 minutes, and patients can immediately return to their daily lives. We have received breakthrough device designation from the FDA for Revita and have evaluated it in over 300 patients across multiple clinical studies, and have observed over 500 patient years of exposure data demonstrating favorable tolerability as well as favorable and durable impact on blood sugar and body weight. Focusing on obesity, despite the popularity of GLP-1 drugs, approximately half of the people who start taking them stop them within one year for a variety of reasons. We believe that what the world needs now is a safe, reliable, and effective off-ramp from GLP-1s, an off-ramp that allows weight loss to persist even as people stop taking these medicines. This is where the unmet need in obesity has shifted from how do you lose weight to how do you keep it off. A Wall Street Journal feature article last week pointed to weight regain as the major problem in obesity management today, and it featured a patient who underwent the Revita procedure approximately one year ago in Germany and who still has durable improvements in body weight and blood sugar today. We, as a company, have always been focused on durable metabolic benefits, and we believe that we are uniquely well-positioned to become leaders in addressing this need in obesity management today. At the end of March, we received IDE approval from the FDA for Ravida's Remain-1 study in patients with obesity who wish to maintain weight loss after discontinuing GLP-1 treatment. The approval from the FDA to begin this pivotal study came earlier than we had expected, and we are excited about our rapid alignment on this pivotal IDE. We believe it is a result of the growing recognition of obesity as a disease and the heightened urgency that has emerged for therapeutic alternatives that do not depend upon lifelong pharmacotherapy. We expect to initiate the study in the second half of the year. We firmly believe that freedom from disease is the ultimate aspiration for people and patients. If successful, the Remain One study would allow Ravida to offer millions of people the potential for durable weight loss maintenance without the burden of ongoing medical therapy. We are also currently evaluating RUVIDA in our Revitalize 1 pivotal trial in patients with inadequately controlled type 2 diabetes. We expect to complete enrollment in the second quarter and share top-line data in the fourth quarter of this year. In Europe, RUVIDA has a CE mark and has secured reimbursement authorization in Germany. We have initiated a commercial pilot launch to conduct a real-world registry study in Germany as we complete our pivotal trials in the United States. We anticipate that registry data, combined with U.S. pivotal data, will be valuable tools to demonstrate the potential impact of Revita to patients and payers. This morning, we shared data from this real-world study at the German Diabetes Association annual meeting, And we found that Revita demonstrated substantial and sustained improvements in blood sugar and body weight through six months of follow-up so far in patients who have enrolled in the German registry. What is particularly exciting about this registry experience is the report from patients themselves. The sense that Revita has offered them a new lease on life and a new hope to live a life that is not defined by their disease. Tim will tell you more about those new data and our clinical development progress, and then Adrian will provide perspective on Ravida's commercial opportunity in just a few moments. Now, turning to our Rejuva platform. Rejuva is our locally administered, AAV delivered, pancreatic gene therapy platform delivering metabolic hormones, including GLP-1, and is designed to enable long-term remission of type 2 diabetes and obesity by durably altering hormone function in the pancreas. At the beginning of this year, we nominated our first Rejuva candidate for type 2 diabetes, Rejuva 001, a one-time locally administered AAV9 viral vector that expresses GLP-1 hormone with an insulin promoter that is designed to durably improve pancreatic function in type 2 diabetes. We expect to initiate our first in-human trials in type 2 diabetes in the first half of 2025. We are also working to nominate our first candidate for a one-time treatment for obesity, which we are planning to announce in the back half of 2024. With that, I'll now turn the call over to Tim to provide additional color on the progress we are making across both our Revita and Rejuva platforms. Tim?