Better Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Better Therapeutics Third Quarter 2023 Business Update Call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question, you will need to press star 11 on your telephone, and you will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mark Heinen, Chief Executive Officer. Please go ahead.

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 Investors section of our corporate website, bettertx.com. Joining me on the call today is Frank Carba, our President and Chief Executive Officer, Dr. Mark Berman, our Chief Medical Officer, and Diane Gomez-Thinnes, our Chief Commercial Officer. During today's call, we will provide a business update and a financial overview of the third quarter of 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 statements. With that, I'll pass the call over to Frank. Frank?

Thank you, Mark, and good morning, everyone. Thanks for joining us on the call today. I am Delighted to start this call with the exciting news that AspireRx is now available for commercial use. We've started receiving prescriptions and have patients on active treatment. Over the past quarter, we have made substantial progress following the news in July that the FDA authorized AspireRx as a Class II medical device indicated to treat adults with Type II diabetes. Our team completed development work to prepare the product for commercial release, establish the necessary organizational infrastructure to launch a regulated prescription product into the market, and continued engaging payers to obtain coverage. Our first opportunity to engage directly with healthcare providers was at this year's American College of Lifestyle Medicine's annual meeting a couple of weeks ago, and it was exciting to see the strong interest in AspireRx. I believe we're truly at an inflection point with a possibility of commercial success now within our grasp. Now, a few months ago, I laid out the three areas we need to de-risk in order to successfully advance better therapeutics. So it's one, obtain FDA authorization, which of course we have, two, demonstrate commercial traction, and three, improve our financial position. In October, we raised approximately $3 million through our at-the-market or ATM facility at an average price per share of 42 cents. We intend to further strengthen our financial position in the coming weeks and extend our runway sufficiently to first demonstrate meaningful commercial traction, particularly in our initial launch geographies to inform the full commercial potential of AspireX, and then second, advance discussions with payers in secure initial coverage. As you will hear from Diane, we are confident both can be accomplished. I will now recap other accomplishments in the third quarter in October of this year. In September, we announced the completion of enrollment of 1,000 participants in our clinical programs evaluating the long-term effectiveness of AspireX in type 2 diabetes. Also in September, our patent, Managing Lifestyle and Health Interventions with Predictive Analytics, was issued in the European Union. Now, this is our second patent issued for four patent families filed by Better Therapeutics, covering the breadth of our novel method of delivering cognitive behavioral therapy, innovative use of patient engagement data and AI methods such as machine learning to predict outcomes and adjust treatment. In October, we announced the preprint publication of the results of our LiveVita LIBER study in Gastrohab Advances, a peer-reviewed journal produced by the American Gastroenterological Association, or AGA. Authors concluded, the totality of positive efficacy, safety, and usability data indicates the potential of better therapeutics digitally delivered CBT to help address the significant unmet clinical needs observed in metabolic dysfunction-associated steatotic liver disease, or MASLD, and metabolic dysfunction-associated steatohepatitis, or NASH. Now, these are the newer terms now for NASH and NAFLD. Also in October, we announced new data from a subgroup analysis that revealed that adjunctive use of Aspirex with standard of care, including GLP-1 receptor agonists, leads to a substantially greater clinical improvement compared to control participants who used GLP-1s but did not incorporate Aspirex into their regimen. We plan on submitting this data for peer review and publication. With healthcare providers prescribing Aspirex and patients engaging in their CBT treatment, we have now transitioned from an R&D organization to a fully integrated commercial one. Our focus for the remainder of the year is to further lay the foundation for successful commercial launch. And in doing so, we have the benefit of incorporating lessons learned from those that came before us. We are pursuing a very targeted go-to-market strategy with the objective to demonstrate meaningful commercial traction in our initial launch geographies to inform the full commercial potential of AspireX which would then allow us to rapidly expand our commercial footprint to other parts of the country. Over the past few months, we have and we continue to prioritize our market access activities with a goal to achieve payer coverage. These discussions have progressed in a positive direction and combined with overall feedback received thus far, we're confident payer coverage will be obtained. As with any new product launch, particularly in a new category like PDTs, payer coverage, of course, will take time to ramp up. And in the meantime, to ensure physicians can gain clinical experience with Aspirex and that eligible patients have affordable access to Aspirex, we're offering a self-pay option for a limited period of time. Now, I'll address the question of revenue guidance. Our plan is to begin sharing guidance once we have obtained a solid understanding of our launch dynamics, which we expect to take at least two to three quarters of commercial experience. Now with that, I'll hand it over to Diane to provide a commercial update. Diane?