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spk03: across the different PDT players are, in many cases, quite different. And I'll take this opportunity to underscore key points of differentiation for better therapeutics, which we believe will drive our ability to gain traction with payers, providers, and patients over the long term. The first and perhaps most important point of differentiation is our therapeutic area of focus. Our current development candidates are intended to treat cardiometabolic diseases, including type 2 diabetes, hypertension, hyperlipidemia, non-alcoholic fatty liver disease, or NAFLD, non-alcoholic fatty hepatitis, or NASH, and chronic kidney disease. We deliberately chose cardiometabolic diseases as our initial target because they, A, share the same lifestyle behaviors as a common root cause, B, rank among the most prevalent and costly chronic diseases that are largely reversible and preventable, presenting opportunities for transformative impact. And C, represent areas of significant unmet clinical need because currently available drugs are often expensive and predominantly treat symptoms, typically resulting in disease progression and more costly healthcare interventions over time. Second is the treatment landscape. Our focus on cardiometabolic diseases, and in particular diabetes, offers access to very large patient populations with high cost of care burdens driving an urgency to act on the side of health systems and payers. In talking with payers for more than a year now, and also validated by numerous third-party research studies, diabetes is a top priority as disease prevalence continues to grow and costs are escalating. Meanwhile, we're not seeing significant improvements in patient outcomes. Furthermore, current diabetes treatment guidelines already call for behavior change as the foundation of treatment, even stating in recent updates that digital health interventions may be useful as an adjunct to standard care to improve diabetes management. We believe this will help with provider adoption as we don't need to change ideas about treatment or the way that it is delivered. Moreover, most drugs are indicated to be used in conjunction with behavior change. And we believe this allows for a more natural and seamless introduction and further adoption of PDTs in the diabetes indication. Third is the significance of the clinical endpoint used in our pivotal trial. not only is the reduction of hemoglobin a1c a universally accepted clinical endpoint for type 2 diabetes by providers and payers alike it is also widely accepted as a proxy for future events in diabetic patients as you know the same endpoint is also used in drug trials and our exploratory endpoints collected data across a broad range of additional health outcome measures providing further clinical evidence for the health impact of our PDT. The initial health economic data shows promising potential cost offsets derived from the utilization of our therapy. And finally, our PDT platform as currently developed is designed to have broad utility and enable rapid expansion across multiple related disease states. This potential for rapid expansion stems from the fact that the underlying root cause behaviors are largely the same for most cardiometabolic conditions. And hence, the behavioral health interventions delivered by our platform to treat these conditions are also largely the same. This is fundamentally different from a traditional pharmaceutical drug approach, where the products to treat different diseases are usually distinct with unique mechanisms of action. I will now recap our accomplishments in the first quarter of this year. We took a number of actions in Q1 to enhance our financial position and ensure the long-term success of the company. This included, among others, a reduction in force, coupled with other cost-saving measures, as well as a 6.5 million private placement in April. Combined, these measures were targeted to extend our cash runway till the end of September, allowing us to potentially reach several important milestones that we expect will further substantially enhance our financial position. These include potential FDA authorization for BD001, as well as a potential BD partnership and or a royalty monetization transaction. Throughout the first quarter of this year, we had multiple rounds of interactions with the FDA regarding our de novo submissions. We highlighted on our last earnings call the request for additional information received as a typical part of the de novo process, and guided that we expected to respond to the FDA by mid-April. We're happy to report that we submitted our response on April 17th, and the agency confirmed the review is progressing. We believe we are on track to receive the FDA's decision by the middle of this year. We also made substantial progress in our preparations for the potential commercialization of BT.001. Specifically, in the last quarter, we filled key leadership positions, including the hiring of a head of marketing and head of medical affairs, both bringing considerable cardiometabolic expertise to the team. Found a contract for hub and distribution services, and building on the growing body of evidence, we had our abstract from the Cardiometabolic Health Congress published in Postgraduate Medicine, highlighting our primary endpoint results. And during the Academy of Managed Care Pharmacy, or AMCP, meeting at the end of March, we had good interactions with payers and have commenced formal preauthorization information exchange meetings. Despite the reduction in force and resulting slowdown of enrollment in our real-world evidence study, We're pleased to report we have enrolled almost 75% of the target participants and expect to complete enrollment by the end of Q3 this year. We then expect to share the first data set in Q4 of this year. And lastly, we expect the submission to the FDA for a breakthrough device designation for the treatment of liver disease to be completed in Q3 of this year. We recently submitted an abstract describing our LiftVita study results for presentation at the European Association for the Study of the Liver, or ESIL, annual congress. ESIL is a leading professional society, and their clinical practice guidelines inform the standard of care for NAFLD and NASH around the world. Our abstract was accepted for poster presentation at the event in June in Vienna, and Dr. Alkhoury, the PI for the study, will be presenting the poster. Over the past few months, we made in part difficult but necessary changes to our business. As a result, I believe we are extremely capital efficient while maintaining the ability to advance with laser focus the potential commercialization of BT.001, which we anticipate commencing within a few months of receiving a decision from the FDA. Diane will now share more detail on our progress. Diane?
spk04: Thanks, Frank. I am thrilled to add to our growing commercial organization with two key leaders in marketing and medical affairs who together bring a combined 40-plus years of cardiometabolic disease and nutrition experience. Our market access work continues, and we're pleased to have consolidated our payer messaging, payer research and health economic modeling, and value-based agreement work streams to complete our Pre-Authorization Information Exchange, or PIE, value story that we have now begun to use in our first payer meetings, as Frank mentioned. From panel discussions and conversations with payers at the recent AMCP meeting, I would like to share the following key takeaways. One, payers are beginning to differentiate PDPs from other digital therapeutics. In other words, those that are FDA authorized versus those that are not. Two, payers see the potential for Medicare coverage through the Access to Prescription Digital Therapeutics Act of 2023 bill as a signal to get ready to cover PDT. And finally, payers are beginning to define pathways and processes for reviewing prescription digital therapeutics. And since the AMCP, we have had several meetings confirmed with payers on our targeted list and are encouraged by the early discussions as we progress towards potential FDA authorization. Veterans Affairs, or the VA, are an important part of our targeted launch strategy. As a matter of fact, one VA site is currently enrolling patients into our real-world evidence programs. We've recently completed a research study to understand more about the patient population and the engagement model. The VA is organized into 18 Veterans Integrated Services Networks, or VISNs, and insights from interviews suggest we take a dual strategy approach, navigating with champions at the national level while also driving local VISN-level advocacy. Key summary points from the study are as follows. The concept of a cognitive behavioral therapy or CBT-based treatment app for diabetes was well received. Pharmacy decision makers responded positively to BT-001's strong safety profile when considering adverse events of a behavioral digital therapy in comparison to those associated with pharmacotherapy. They also perceived no negative impact on the pharmacy budget. Pharmacy leaders agreed BT-001 could be used at any stage of diabetes progression throughout a patient's journey, but felt it would be used as early as possible. They agreed that BT-001 would fit in the current VA clinical practice guidelines as an individualized diabetes self-management education treatment tailored to a patient's preferences, learning needs, and abilities. And finally, a decrease in HbA1c and outpatient visits were cited most in terms of measures for a successful diabetes treatment. We look forward to taking these valuable insights as we move into meetings with key supporters at the national level while developing our VISN-level coverage approach. As we refine our plans for market entry, the first phase in our launch will be focused on continuing efforts to expand coverage amongst payers. Covered lives will be a key metric and determinant of success for us. We anticipate follow-up meetings with payers upon FDA authorization, and we will prioritize the hiring of our field payer team in this effort. We know it is critical to also have provider demand and clinical champions in the marketplace. Health system characterization continues as we further refine our list of 50 health systems mapped from patient claims analyses we conducted in the fourth quarter of last year. Our goal is to identify those health systems that are innovative and more likely to adopt BT-001. Indicators include the ability to influence provider networks, engaging in value-based contracts, and focusing on population health studies or initiatives in diabetes or other large population diseases. As we create awareness and to accelerate our target payer's willingness to review for coverage via PI meetings, we will prioritize health systems mapped to these payers. Our plan is to initiate the build-out of field teams in specific geographies where we see positive momentum with payers and providers for a focused regional market entry. And this represents a thoughtful approach to our ramp-up, responsibly and efficiently managing our resources. With regards to provider engagement, in the first quarter, we also onboarded key opinion leader advisors who are serving to guide our marketing efforts. Early insights gathered will inform our broader research. I'm delighted to hear from practicing clinical experts who have not had prior exposure to or experienced with VT001 about their enthusiasm for this novel therapeutic and the clinical data that supports it. Advisors value a clinical endpoint that matches what they expect in drug trials, the reduction in HbA1c. They're encouraged by the health economic data where VT001 may offset costs of expensive pharmacotherapy. They recognize the exciting innovation here as a shift to behavioral therapy, which may increase the chance for patient change beyond what monitoring alone can do to increase awareness of blood glucose impact from food choice. And, like medication, it's critical to have BT-001 prescribable in their e-prescribing workflows. Finally, we're pleased to report that we have engaged our distribution partner, Phil, leveraging its PhilRx patient access platform to improve access to prescriptions, simplify the patient experience with their prescription, and manage both pharmacy and medical benefits processes. Phil's technology solution offers the capabilities companies like ours in the PDT space need, and it has already been implemented with a number of prescription digital therapeutics commercially available today. Mark Heinen, our Chief Financial Officer, will now review our first quarter 2023 financial results. Mark?
spk01: Thank you, Diane. I'll begin by discussing our operating expenses for the first quarter of 2023. Research and development expenses were $3.4 million for the quarter ended March 31st, 2023, compared to $3.7 million for the same period in 2022. The decrease was primarily due to an increase in capitalized software development costs, offset by a decrease in clinical study costs. Sales and marketing expenses for the quarter ended March 31, 2023, were 2.1 million, compared to 2 million for the same period last year. The increase was primarily related to higher personnel-related costs associated with our commercial readiness activities, partially offset by lower real-world evidence-related expenses. General and administrative expenses for the quarter ended March 31, 2023 were $3.4 million, compared to $3.6 million for the same period in 2022. The decrease was primarily related to lower business insurance costs, offset somewhat by an increase in personnel and related costs. Interest expense for the quarter ended March 31, 2023 was $400,000, compared to $300,000 for the same period last year. The increase was primarily the result of an additional $5 million borrowed under the company's secure term loan agreement with Hercules Capital in the second quarter of 2022. Net loss for the quarter ended March 31, 2023 was $9.4 million compared to $9.7 million for the same period last year. On a per share basis, net loss was $0.39 compared to $0.41 last year. The decline in loss per share is related to an increase in weighted average shares outstanding and a decline in net loss. Moving to our balance sheet, cash and cash equivalents were 6.1 million on March 31st, 2023, compared to 15.7 million on December 31st, 2022. In April 2023, we completed a private placement for gross proceeds of 6.5 million. On a pro forma basis, taking into account the private placement, Cash and cash equivalents was $12.6 million at the end of the first quarter. Our cash burn in the first quarter included a number of one-time expenses totaling approximately $1.6 million, including fees related to our recent financing, a principal payment under our Hercules Debt Facility, and others. However, as a result of the restructuring and other cost savings initiatives, our cash burn has now been meaningfully reduced. These initiatives include amending the term loan agreement with Hercules, which among other things provides for a delay in principal payments for up to six months. The cost savings initiatives, delay in principal payments, and proceeds from private placement are expected to extend our cash rate runway toward the end of Q3, allowing us to potentially meet several key milestones, including FDA authorization, a business development transaction, and or a royalty monetization transaction. With that, I'll turn the call back over to Frank for some closing comments. Frank?
spk03: Thank you, Mark. Before we wrap up, I would like to come back to our financing strategy. As I shared previously, we are pursuing a three-tiered strategy, which consists of capital markets-based financings, business development, and structured non-shared dilutive financings, such as a royalty monetization transaction. While we have executed on one element of the strategy with our private placement, we recognize our cash resources need to be further enhanced. And as Mark mentioned, with the actions taken to extend our cash runway, we believe we have sufficient time to meet one or several of the milestones critical to our success. Each of these milestones are either catalysts for further financing opportunities or directly result in meaningful cash injections or both. And it is worth noting that when we completed our recent private placement, we could have done a larger deal, but deliberately decided to do a smaller deal on better terms because we felt it was the right thing to do for the company and for shareholders. We also believe it better sets us up for long-term success, and it reflects our confidence in other elements of our financing strategy coming to fruition. Since the private placement, we have made significant progress in our various business development discussions and are optimistic about our ability to continue to deliver on several elements of our financing strategy. And until we know where we come out on these elements, we're operating on a highly cost-efficient basis. In closing, the industry is at an inflection point. Whether it's the advancement of the access to prescription digital therapeutics act, or the continuously increasing interest of payers in PDTs, the industry is evolving in ways that are beneficial to us. We believe we are in a very good position to succeed. Largely because of our focus on cardiometabolic diseases with type 2 diabetes as our lead indication, we expect the dynamic of our launch to be different from what has been observed in prior PDT launches. And we look forward to bringing our groundbreaking therapeutic to the providers and patients who urgently need them. And finally, I want to again thank the entire Better Therapeutics team for the unwavering passion and commitment to patients that they demonstrate every day. And with that, we're now ready to take your questions. Thank you.
spk07: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Thomas Flatton at Lake Street Capital Markets. Thomas, your line is open.
spk09: Good morning, everyone. Thanks for taking the questions. Frank, I was wondering if you could comment on the dialogue with FDA. Did they provide any hint as to the sufficiency of the responses that you put in?
spk02: Hey, Thomas, good morning. Thanks for your questions. We cannot comment on what exactly the FDA responded back to us, but what they did tell us is that they accepted our resubmission and that the review continues to progress. They further gave us an indication that led us to believe that we're now on the final 90 days of the review. That is going back to the submission date, which was April 17th.
spk09: Got it. And congrats on the enrollment in the real-world studies. I was curious if maybe you could preview for us a little bit, you know, how many patients we'll see, what follow-up time period, what types of endpoints we might see when we roll into the fourth quarter and you're ready to announce some of that data.
spk02: Yeah, we can add a little bit of color of what to expect here. And I would like to invite Mark Berman into the conversation. Mark, do you want to comment on this?
spk08: Happy to. Thanks, Frank. And good morning, Thomas. So the real-world evidence program, as you know, is going to enroll approximately 1,000 patients across the multi-site study. And as we mentioned, we're about three-quarters of the way enrolled that study and expect to be fully enrolled by the end of Q3 2020. In Q4, we will release interim results. These will be results of six months duration, so change from baseline. We'll focus on A1C change at that time. And we're going to release contingent on having sufficient power. So obviously, this won't be the full set of patients as they'll be interim results. And we'll make sure that we release results when we have a sample size that gives us sufficient power and therefore sufficient confidence in the results that we'll share.
spk09: And just a follow-up on that, will those data then be rolled into your dossier that you use in discussions with payers, or will you wait for the study to be complete?
spk08: Yeah, that's a great question. I'll start, and then we can turn it over to Frank or Diane to comment on that. So our belief is that this data, while going to be super helpful in the long run for providers and in the long run potentially for payers, is not necessary for initial commercial launch or initial discussions with payers. So we are not planning to wait on this data.
spk04: Correct, Mark. Thank you. Good morning, Thomas. I'll just add to say that, of course, real-world evidence studies are always important to payers, but even from some of the early conversations we had on value-based agreements, there's a real understanding that behavior change is very likely to change clinical outcomes for patients. And so a lot of our conversations with payers have focused a lot on engagement metrics. But, you know, of course, any data that becomes available, we'll look to utilize.
spk09: Excellent. I appreciate you guys taking the questions. Thank you.
spk07: Thank you. You're welcome. Please stand by for our next question. Our next question comes from Charles Rhee of TD Cohen. Charles, your line is open.
spk10: Hi, this is Lucas Alpert-Charles. Thanks for taking the questions. Curious to see or to hear how your conversations with health systems and providers have gone up to this point, you know, given that physicians may prove to be a harder sell than payers when it comes to using PDTs. I'd like to hear how your interactions with physicians and health systems, particularly in the regions that you're targeting, have gone up to this point. just maybe some detail around what you guys are doing specifically to maybe overcome what may be a stigma among patients around prescribing digital therapeutics.
spk02: Yeah, good morning. Thanks for your question. I will hand it on to Diane here in a moment, but let me maybe just start. You mentioned at the end stigma that may be around patients here. This is actually, I think, one of the things we were different from perhaps other PDT launches that you saw in the past. We don't think we actually have this issue that we're dealing with highly stigmatized patients. We are dealing with type 2 diabetes with a patient population that is highly prevalent, that has high cost of care burdens associated with it, and that has high degrees of unmet medical needs. You may recall we shared earlier that you know, only about 50% of patients that are on the standard of care medications do in fact have their blood sugar under control. And these patients are being treated, you know, in the mainstream of our healthcare system by endocrinologists and primary care physicians. So we actually don't think that there's stigma around, you know, digital health interventions. As I said in my prepared remarks, the treatment guidelines for type 2 diabetes, not only do they call already for behavior change, as the foundation of treatment in the most recent update, it actually also now references digital health interventions. So we think we're very well positioned here. But Diane, maybe you can share a little bit more color of what we're hearing from providers and peers alike in the various interactions that we've had over the last few weeks.
spk04: Yes, absolutely. Thanks, Frank. And good morning, Charles. I do think it's important to separate out the payers and the providers. In the payers, clearly there's more understanding for prescription digital therapeutics as a category. And I think, you know, an additional add to what Frank has already stated, that we've already been speaking with payers for the last 12 to 18 months. And since the beginning, you know, the team has been asking what they would need to consider for reviewing BT-001 and considering coverage. And we looked down the list of everything we've heard over this time period, and we're ready to deliver on those expectations that payers have. And that includes FDA authorization, having an adequately sized and controlled trial design, diverse populations, which I know have been Very much appreciated by payers. The clinical endpoints, A1C, which are accustomed to be understood in that clinical setting in drug trials, different than symptom alleviation types of endpoints, safety and efficacy data, and also engagement during treatments. You know, one of the important things to note as well is that there is more recognition among payers around the differences in prescription digital therapeutics. So while it's important to look at this as a category, it's also important to look a little bit deeply. So Frank noted some of those differences maybe with our product and the space in which we play versus other prescription digital therapeutics. It's also important to understand that we are also seeking a treatment claim, and so the level of evidence that we are presenting is much more robust than a payer may typically understand, let's say, from a 510 clear type of device. So it's important for us to point out some of those differences, and payers are beginning to recognize that the level of evidence from one PDT to another is important as part of their review. On the provider side, I'm actually quite pleased. It was really important to start engaging providers who, you know, I think it's important to know, are less aware about PDTs as a category. And so when we speak to providers, we're speaking specifically to our therapy in type 2 diabetes, and they don't have necessarily the knowledge of PDTs in other disease areas. And as we've onboarded some key opinion leader advisors who also serve as advisors for big pharma companies and other device companies, I'm super pleased about their reaction as they're exposed to BT-001 and all the clinical data that supports it. We continue to engage to inform our broader research and research. Again, here I would say what's really pointed out by our early research is this value around the clinical endpoint that matches what they expect in drug trials, and in our case, this reduction of A1C. Even without being experts in the health economic data, they understand the costly impacts on their patients. with expensive pharmacotherapy and the management of systems and this feeling of advancing from one medication to the other. So they're encouraged by the health economic data and really encouraging us to make sure we're publishing, which of course we've advanced that work. And they do see this as exciting. You know, right now it's been thought of, you know, monitoring really has been, you know, important, especially as innovation and monitoring has continued to improve and increasing awareness of a patient's blood glucose and choices they make every day is really important. They really see this as adding to that chance for patients to make real change and really improve what normally has been just a progressing disease from one medication to another. So, you know, at this point, we're really encouraged by the conversations that we're having with advisors who have not had experience exposure to our therapy.
spk05: Okay.
spk10: Yeah, that's encouraging. And then, can you guys update us on the progress made around using the data collected on outcomes and engagement and building out personalization features into your platform? I understand that you guys are intending to see these capabilities embedded into the platform at the time of BT.001's launch. Now that we're getting closer to commercial launch, could you guys give us an update on what these capabilities around personalization
spk02: personalization of treatment and experience may look like well let me start and I'll ask mark Berman to chime in as well the first thing to recognize is that the product as it was used in our randomized control trial just already include a high degree of personalization the treatment algorithms that are AI powered the dynamically adjust the treatment pace and intensity to each individual patient. One of the features of digital therapeutics in general is that they are subject to continuous improvement based on the varied data that the use of these therapies generates. And so we have, of course, made additional improvements, and that is a development that will continue over time as more and more data is being collected. I think the engagement data, I think, is the data we've shared previously from our randomized controlled trial, and I think the numbers were exceptionally strong. We saw 81% of patients that were engaged with our PDT after six months, with on average spending six minutes in-app per day. So those were really exceptionally high engagement metrics. And the, you know, the NPS scores as a measure for patient satisfaction was also exceptionally high with an NPS score of 61. I think we, of course, we continue to collect data around this currently in our real-world evidence program. And once we release the next batch of data, we will, of course, also include engagement data again. And as a last point, I'll say you may recall The engagement data that we released on our pilot study in liver disease, that's the VDEF study where we evaluated the utility of our platform in national FLD, had even better engagement metrics than what we saw in the randomized trial, though I will say it was also a smaller sample size. Mark, do you want to comment a bit more on sort of the level of personalization that's embedded in our product?
spk08: Happy to, Frank. I mean, I think you did a wonderful job of summarizing that. In the end, Lucas, the product that was tested within the BT001 pivot has a high degree of personalization. And of course, with every opportunity to study the product, with every opportunity to expose it to another cohort of patients, we gain valuable usability data, valuable engagement data, valuable satisfaction data. and we've made a number of refinements to the product that will go into the commercially launched product. But the core tenants of personalization are going to remain as they are because they're working well. As Frank mentioned, those personalization elements include really the ability for any patient to engage with the platform independent of their current state of behavioral achievement or activation, if you will. The algorithm that guides the patient's behavioral change really does respond to the current state of the patient, and as they advance at their own unique pace, tries to advance that patient forward at a pace that's going to be right for them to make behavioral changes that not only will be effective, but also will be sustainable, and we see that very much reflected in our data. When we look deeper at the data, we see a gradual shift in behaviors starting from wherever patients are. We see those progressing over the six months, and we don't see yet a peak degree of change, suggesting that we've created a pattern that is more consistent with the sustained behavioral changes. The other elements of the cognitive behavioral therapy, including the lessons, include personalization elements. There's a large bank of skills recognizing that the behaviors that we are trying to change really do represent a very broad set of eating and other living lifestyle and self-care behaviors. And patients will need to acquire a diverse set of skills in order to be effective. And the platform allows that patient to personalize their experience to the different skills that are going to be beneficial to them. In addition, the computer generated feedback, if you will, is omnipresent throughout the solution so that from the beginning of treatment, the patient is getting a sense of whether their combination of engagement, their behavioral change, their biometrics, is suggesting that they are going to be on track to receive benefit from the solution and guides the patient, if they are not, to additional content, additional activities that are intended to help overcome barriers to change. So there's a rich, I'll summarize this thing, there's a rich set of personalization features We've essentially tested all of those and what we're going to be releasing in the commercial product are refinements based on the usability data that we have. And I think I'll echo what Frank said. I mean, we're incredibly excited about the opportunity to launch this product hopefully in the commercial world because it's very clear that as we gain larger cohorts of patients, that data is really invaluable at allowing us to further refine both the feature set and the algorithms that drive the patient experience.
spk05: Great. Thanks for taking questions. Thank you very much.
spk07: Please stand by for our next question. Our next question comes from the line of Kay Nikkei at Chardon. Kay, your line is open.
spk06: Yeah, thanks. My question is on the BD side and the potential commercial partner. I guess from your perspective, again, given kind of the early history of PDTs partnering for commercialization, what are you really looking for in an ideal partner? And I guess maybe specific to diabetes, as we've seen at least on the device side, there's a lot of post-sales hand-holding required for patients with this disease. So how important is that?
spk02: Thanks. Thanks, Kay, for your question. Good morning. So on the partnering side, as I mentioned on, I think, our prior earnings call, we have multiple discussions that we're currently entertaining with different types of companies that span the gamut from pharma to medical device to tech. And The nature of these discussions is in each of these cases slightly different and we could benefit from a potential partnership in multiple ways. You could imagine a partnership that might support the commercial launch in the US and help us successfully commercialize our PDT in the US market. You could separately see a partnership that maybe supports expanding our geographic footprint and help us commercializing our PDT in markets outside of the United States where we're currently really not set up to do this ourselves. Thirdly, you can imagine a partnership to support the expansion of our pipeline, meaning expansion beyond type 2 diabetes into other cardiometabolic conditions, particularly those where we already have proof of concept and where with a partner we would be able to progress faster. You could also see, as a fourth example, opportunities to combine our PDT with certain other medical devices. So it's a very broad gamut, and the value proposition to us, I think, is different depending on who we're talking to.
spk06: Anything that is... diabetes, disease-related that's important from your perspective?
spk02: Say that again so I could not hear you.
spk06: Anything that is diabetes, disease-related that it's important that the partner understand that you're looking for from your end?
spk02: Yes. I mean, you know, we don't I think the fundamental point here is that we don't view our PDT as an adjunct to a drug, to a pharmaceutical drug. We view our PDT as a self-standing product that delivers value on its own and generates revenue on its own. So that's maybe one key point here and of course experience in type 2 diabetes or other cardiometabolic conditions depending on whether the partnership is focused on supporting our launch in type 2 diabetes or whether it's focused on expanding our pipeline therapeutic area expertise and capabilities that can help with market access medical affairs and ultimately sales and marketing of course, would be beneficial. And I don't know, Diane, is there anything that you would want to add from your standpoint?
spk04: Yes. Thanks, Frank. So we do see this as a revenue-generating treatment and not necessarily specific to any one drug. And we feel you're capturing even features of adherence of drugs is important in our technology. I think what's really important to understand is that this isn't a companion app of any sort. There's a lot of digital therapeutics or digital solutions that are certainly advancing amongst many players in the pharmacotherapy, the devices space, and even in the consumer space. So I think that's an important differentiator that we see this as a drug therapeutic that can be revenue generating. You know, I think what's important to understand as well, because I heard the comment, Kay, with regards to hand-holding with patients is, you know, we're extremely excited about the data we've already seen in our pivotal trials with level of engagement where patients were not necessarily incentivized to use the app. They were not incentivized to use the app, and nor was there anything additional kind of human interaction through that process. But we do know from conversations now, for example, with payers and with providers, the importance of ensuring the education of diabetes nurse educators who are already part of the treatment support for patients with diabetes and also diabetes disease management that exists. So what's encouraging is that payers and providers together are signaling this therapy being part already of this treatment pathway. And so we are encouraged about those specifics related to type 2 diabetes.
spk02: And I would just clarify maybe one last point. As Diane said, we don't view our PDT as a companion app, but as a self-standing product. But that is not to say that using our PDT alongside a pharmacotherapy that a partner may have on the market, it could generate additional benefits, clearly. I mean, we've shown that in our randomized controlled trials where the combination, where we demonstrated that the combination of our PDT with a standard of care yields better outcomes, both in terms of safety and efficacy than standard of care alone. You could further, you know, think about avenues where the pairing of a of a pdt with with a pharmacodrug might result in better medication adherence because you know you have a platform that allows you to engage with a patient on a daily basis and so forth so i just want to say while we view our pdt as having independent value there is an incremental value proposition that could be realized um in cases where a partner might have existing pharmacotherapies on the market.
spk06: Okay. Well, thank you for answering my question.
spk07: Thank you very much. Please stand by for our next question. Our next question comes from the line of Raoul Rocket from LifeSci Capital. Raoul, your line is now open.
spk11: Hey, good morning, guys. Look, I know I've asked this before, but, you know, given that you guys, you know, further honing in on commercial strategy ahead of a launch, I was just thinking how you're thinking about positioning, you know, BTO1 to physicians. You know, obviously current treatment guidelines call for behavioral therapy as a first-line therapy, but, you know, we saw it in the pivotal study that you guys treated patients with pretty advanced disease and saw compelling changes being made to their medication usage. So, you know, just as you guys talked start to build out the sales force and prepare them for those introductory conversations with endos and PCPs? I guess, which side, if you are picking one of the spectrum, do you intend to focus on?
spk02: Thank you for your question, Raul. Good morning. I will say it may be a little bit too early to comment in great detail on this, and we may reserve some of this maybe for the next call. when we are closer to actual launch. But Diane, maybe you want to provide already some high-level thinking around the question that we will just ask.
spk04: Sure. Rahul, good morning. Love this topic, and it's important to recognize that as we've onboarded advisors, this is really a lot of the first and foremost set of work that they are helping to guide us with. So their early insights, how they see potential for positioning, having us make sure we carve out a different place in the market because this therapy is so differentiated than, again, the many companion apps that are out there. solutions in the wellness space, other types of therapies. And so it is a little bit early to say, but I'm encouraged just as recent as this week being able to engage with providers on some potential positioning work. And so, you know, a little more to advance there before we talk more in depth, but certainly ongoing work that we're doing at the moment.
spk11: Got it. No, I appreciate that. And look, I know you guys are heads down focused on a future launch, but given that you have some of these other plants within the pipeline to develop out these assets down the road, I guess given the size of typical studies in NASH, hypertension or hyperlipidemia, I guess what are the estimates around what a pivotal trial in one of these indications might cost and what resources are needed to to execute a trial like that?
spk02: I'll say two things. The first one is while we have, as you know, pilot data for national, the hypertension, hyperlipidemia, and we believe we have the data in hand to then go and design the next set of pivotal trials. We are currently not pursuing this at the most on hold just because we need to focus our precious financial resources on getting through FDA authorization, advancing our preparation for commercial launch, and really making sure that we have the eyes on the price here first and get type 2 diabetes over the line and are ready to launch. The moment that we have additional financial resources, and this could come through a number of different avenues, as I alluded to, we're pursuing this. The moment we have financial resources, then we continue those additional explorations to expand into other indications and initiate other trials. I just want to be clear that we're very focused right now on where we're spending our money and where we're spending our time. One of the, I think, attractive features of developing PDTs is that the time and cost required to get through these pivotal studies is a fraction of what it is for a typical pharmacological agent. And Mark Berman, maybe you wanted to give a high level estimate of how we think about the cost and time around a pivotal trial, let's say for nationality, but it equally applies actually to other indications as well.
spk08: Yeah, I think that's right. Good morning, Rahul. You know, so to build on Frank's comments, recall that our initial pivotal study and about 668 patients is considered one of the most robust pivotal trials for a medical device or a prescription digital therapeutic. And it really was submitted to the FDA as a pivotal trial as a part of the de novo pathway. Our anticipation and our strategy is that, you know, assuming we will get authorization for BT-001, Subsequent indications are going to be filed under the 510k pathway because the underlying platform is substantially similar. We will already have had a robust safety data set that has been gathered. That safety data set was very strong. And so there will be a need to establish a new data set to advance specific claims, for example, as a treatment for an astronaut. But because of that earlier predicate work, the future studies are expected to be smaller than the pivotal study. Obviously, they'll all be individually powered, so they'll have individual sample sizes depending on the effect sizes that we're looking to see in each indication. But similarly, we think that most of these trials on average are going to be about a six-month treatment period, enough to demonstrate safety when the patient is using the device as it's intended, and enough to generate an effectiveness or efficacy signal to establish the claim. So NET is, you know, as Frank mentioned, you know, these are, while they would be randomized controlled trials and still robust trials, they're kind of a fraction of the duration and a fraction of the cost of a traditional drug trial. And so, as Frank mentioned also, we're really excited to commence work on those once we have resources. At the moment, we're staying focused on B2001.
spk02: You asked, Roel, specifically what does this cost? I mean, the type 2 diabetes pivotal trial costs between $10 and $15 million. And for national athletes, it might be slightly higher, but not much. I would say it's roughly in the same ballpark, more in the upper end of that range. So it's you think about you know these are at the end of the day sort of face these studies that the data which is then being used to seek additional authorizations from the fda again it's a it's a fraction of what it would be for for sort of a normal pharmacological agent got it that's helpful i appreciate that uh and then just one more uh clarification question uh for me i apologize if i missed it earlier but
spk11: Just obviously assuming clearance and a subsequent launch later this year, how should we think about incremental changes to OPEX over the next couple quarters?
spk02: Thanks. Generally, you can expect OPEX to continue to actually decline right now. That's really because the impact from the restructuring is still working its way or has worked its way through our P&L in the early parts of of the second quarter because that's when we sort of implemented it. And then going forward, you will see that operating expense continues to go down. And we're going to continue to operate on a highly cost-efficient basis until additional funding is secured. And as we said multiple times here, we feel pretty optimistic that with the actions we've taken, both in terms of the product placement that we completed a few weeks ago and with the cost containment measures that we have extended our runway sufficiently to get to the multiple milestones such as potential FJ authorization, potential PD transaction, possibly a royalty monetization transaction. So we have the time we believe to now get one or several of these to the finish line and each of them either result directly or could unlock opportunities to potentially substantial additional funding. But until then, we're going to operate very, very efficiently, and that means that you will see our operating expense continue to decline over the next couple of quarters.
spk05: All right.
spk07: Thank you very much. At this time, I would like to turn the call back to Frank Carb for closing remarks.
spk02: Well, thank you very much for your interest this morning and joining us for this call. We feel very good with where we are. I hope we were able to convey that, and we look forward to keeping you updated on the progress. And if in the meantime you have questions, please feel free to contact us. Thank you. Bye-bye.
spk07: Thank you for your participation in today's conference. This does conclude the program, and you may now disconnect. Thank you.
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