Better Therapeutics, Inc.

Good morning and welcome to the Better Therapeutics fourth quarter 2022 financial results and business update conference call. After the speaker's presentation, there will be a question and answer session. Instructions will be given at that time. As a reminder, this call may be recorded. I would now like to turn the call over to Mark Hindman, Chief Financial Officer. Please begin.

Thank you, Operator. Good morning, everyone, and welcome to the Better Therapeutics conference call. Our press release was issued this morning and can be found in the investor section of our corporate website, bettertx.com. Joining me on the call today is Frank Carva, our president and chief executive officer, Dr. Mark Berman, our chief medical officer, and Diane Gomez-Dennis, our chief commercial officer. During today's call, we'll provide a business update, a financial overview of the fourth quarter and fiscal year 2022, and provide our outlook for 2023. A Q&A session will follow our prepared remarks. Before we begin, I'd like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans, and expectations and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events and results may differ materially from those expressed or implied by any forward-looking statement. With that, I'll pass the call over to Frank Harbaugh. Frank?

Thank you, Mark. Good morning, everyone, and thanks for joining us on the call today. The fourth quarter and full year 2022 were marked by significant progress for better therapeutics, and that momentum continues into 2023 as we advance our preparations for the anticipated commercial launch of BT-001 in type 2 diabetes, if authorized by the FDA. Now, before I recap our accomplishments in 2022, I will address the recent actions we took to ensure the long-term success of the company. On March 23rd, we announced a reduction in force, impacting approximately 35% of our colleagues. I also shared that we are implementing other cost savings measures to extend our financial runway so we can reach our critical milestones. I want to underscore our long-term outlook for the potential of our digital therapeutics platform, and that is not just in type 2 diabetes, but potentially many other cardiometabolic diseases, remains unchanged. We continue to believe that we will demonstrate the significant medical and commercial potential of our therapeutic approach. And furthermore, our guidance for potential FDA authorization remains unchanged, and we continue to prepare for commercial launch. were structured in a way to preserve all key capabilities across the company to meet our critical milestones. However, where we did lose bandwidth, the speed at which we expand into new indications may be impacted. Now, I'll recap our accomplishments in 2022 and in the first quarter of this year. Last summer, we completed the largest randomized controlled pivotal trial to date for treatment of type 2 diabetes, by a prescription digital therapeutic. The trial met both its primary and secondary endpoints, showing statistically and clinically significant durable decreases in A1C, as well as positive results across a range of exploratory endpoints. We subsequently submitted a de novo classification request to the FDA, seeking marketing authorization for BT001. to potentially become the first prescription digital therapeutic for the treatment of type 2 diabetes in adults. And if authorized by the FDA, this would give physicians a clinically validated prescription solution delivering cognitive behavioral therapy from a mobile device with a promise to help patients make and sustain the behavior changes that the type 2 diabetes treatment guidelines are already calling for as the foundation of therapy. CBT in its traditional in-person setting has been well researched and shown to be effective in type 2 diabetes and related cardiometabolic conditions, but it lacks scalability, which our investigational digital therapeutics is designed to overcome. It is worth noting that the underlying behaviors causing type 2 diabetes are largely the same for many other cardiometabolic conditions, supporting our belief that our investigational digital therapeutics platform has the potential to be rapidly scaled across many other cardiometabolic conditions. Our groundbreaking approach and BT-001 pivotal trial results were published in one of the largest peer-reviewed diabetes journals, Diabetes Care, in the fourth quarter and presented at several medical conferences, including at the American Heart Association last year and most recently at the American College of Cardiology earlier this month. In December 2022, we also completed and reported positive results from a pilot study, evaluating the feasibility of using our investigational prescription digital therapy platform for the treatment of NASH and NAFLD. The VITA liver study met its primary endpoint and showed statistically significant and consistent improvements in magnetic resonance imaging proton density fat fraction, or MRI PDFF, and a broad range of liver biomarkers. These results support our belief in the potential for our PDT to become standard of care, either alone or in combination with future pharmacotherapy treatments, as currently there's no FDA-approved treatment for these conditions, which affect approximately one in four Americans and cost approximately $100 billion in direct medical costs annually. Now, as we look to the first quarter of 2023, the review of our de novo submission has steadily progressed since the FDA accepted our submission in October of last year. We've had multiple rounds of interactions with the agency, including a request for additional information, which we received in February, and is a typical part of the de novo review process. Also in February, we had a meeting with the FDA to clarify several of the items noted in the request. The work to address the FDA's questions is well underway And our previously provided guidance that we anticipate the FDA's decision by the middle of 2023 remains unchanged. And we've made substantial progress in preparing for the potential commercialization of BT-001. Specifically, in the last quarter, we completed our health economic models, conducted several studies to inform our value proposition to payers, and advanced contract negotiations for hub and distribution services. In addition to these key accomplishments, there are many other areas where we have advanced our business. And we believe our platform technology, intellectual property portfolio, and groundbreaking clinical research puts us in a leadership position in this rapidly evolving prescription digital therapeutics category. The digital therapeutics market as a whole is seeing tremendous growth. And with recent research by Global Market Insights projecting revenues to hit 100 billion by 2032, we believe Now is the time to be innovating in this space. This and recent use of the bipartisan Access to Prescription Digital Therapeutics Act of 2023 being reintroduced in Congress underscores a recognition of the promise of PDTs and is an important next step towards gaining coverage of PDTs by Medicare and Medicaid, helping millions of Americans receive innovative care to treat a growing range of conditions and illnesses. I will now hand the call over to Diane to provide a more in-depth update on progress in preparing for potential commercial launch. Diane?