Better Therapeutics Inc (BTTX) 2023 Q1 法說會逐字稿

Good morning and thank you for standing by, and welcome to the Better Therapeutics' first-quarter 2023 conference call. (Operator Instructions)

早上好，感謝您的耐心等待，歡迎參加 Better Therapeutics 的 2023 年第一季度電話會議。 （操作員說明）

Please be advised today's conference is being recorded.

請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, Mark Heinen, Chief Financial Officer. Please go ahead.

現在我想將會議交給今天的發言人、首席財務官馬克·海寧 (Mark Heinen)。請繼續。

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 Karbe, our President and Chief Executive Officer; Dr. Mark Berman, our Chief Medical Officer; and Diane Gomez-Thinnes, our Chief Commercial Officer.

謝謝你，接線員。大家早上好，歡迎參加 Better Therapeutics 電話會議。我們的新聞稿於今天上午發布，可以在我們公司網站 bettertx.com 的投資者部分找到。今天和我一起參加電話會議的是我們的總裁兼首席執行官 Frank Karbe；我們的首席醫療官 Mark Berman 博士；以及我們的首席商務官 Diane Gomez-Thinnes。

During today's call, we will provide a business update and a financial overview of the first quarter of 2023. A Q&A session will follow our prepared remarks.

在今天的電話會議中，我們將提供 2023 年第一季度的業務更新和財務概覽。在我們準備好的發言之後將進行問答環節。

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 that 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.

在我們開始之前，我想提醒大家，我們在本次電話會議中所做的任何非歷史事實的陳述或提供的信息都是前瞻性陳述，這些陳述基於我們當前的信念、計劃和期望，並根據1995 年《私人證券訴訟改革法案》的安全港條款。實際事件和結果可能與任何前瞻性聲明明示或暗示的內容存在重大差異。

With that, I'll pass the call over Frank Karbe. Frank?

這樣，我會將電話轉給弗蘭克·卡布。坦率？

Thank you, Mark, and good morning, everyone. Thanks for joining us on the call today. We successfully navigated several challenges in Q1. And with that, we believe laid the foundation for our long-term success. We also advanced our interactions with the FDA and are now within the final 90 days of our review. And with that in mind, we have continued to advance our preparations for the anticipated commercial launch of BT-001 in type 2 diabetes, including discussions with potential launch partners.

謝謝你，馬克，大家早上好。感謝您今天加入我們的電話會議。我們在第一季度成功應對了多項挑戰。我們相信，這為我們的長期成功奠定了基礎。我們還推進了與 FDA 的互動，目前已進入審核的最後 90 天。考慮到這一點，我們繼續推進 BT-001 治療 2 型糖尿病的商業上市的準備工作，包括與潛在的上市合作夥伴進行討論。

Before I recap our accomplishments in the first quarter, I want to acknowledge the news of Pear Therapeutics' filing for bankruptcy. This is obviously a devastating outcome for Pear and setback for prescription digital therapeutics or PDTs. As one of the true pioneers in the industry, Pear paved the way for the investment and innovation, their contributions to creating PDTs as a new category.

在我回顧第一季度的成就之前，我想先了解一下 Pear Therapeutics 申請破產的消息。這對於 Pear 來說顯然是一個毀滅性的結果，也是處方數字療法或 PDT 的挫折。作為該行業真正的先驅之一，Pear 為投資和創新鋪平了道路，他們為創建 PDT 作為一個新類別做出了貢獻。

However, the difficulties likely raised doubts around the commercial viability of PDTs. And it is therefore more important than ever to perhaps highlight that the dynamics 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.

然而，這些困難可能引發人們對 PDT 商業可行性的懷疑。因此，也許比以往任何時候都更重要的是要強調，在許多情況下，不同 PDT 參與者的動態是截然不同的。我將藉此機會強調 Better Therapeutics 的差異化關鍵點，我們相信這將推動我們長期吸引付款人、提供者和患者的能力。

The first and perhaps the most important point of differentiation is our therapeutic area of focus. Our current development candidates are intended to treat cardio-metabolic diseases, including type 2 diabetes, hypertension, hyperlipidemia, nonalcoholic fatty liver disease or NAFLD, nonalcoholic steatohepatitis or NASH, and chronic kidney disease.

第一個也是最重要的區別點是我們的重點治療領域。我們目前的開發候選藥物旨在治療心臟代謝疾病，包括2型糖尿病、高血壓、高脂血症、非酒精性脂肪肝病或NAFLD、非酒精性脂肪性肝炎或NASH以及慢性腎病。

We deliberately chose cardiometabolic diseases as our initial target because they, a, share the same lifestyle behaviors as a common root cause; b, ranked 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 treats symptoms, typically resulting in disease progression and more costly healthcare interventions over time.

我們特意選擇心臟代謝疾病作為我們的最初目標，因為它們： a 具有相同的生活方式行為作為共同的根本原因； b，屬於最普遍和最昂貴的慢性病之一，這些疾病在很大程度上是可逆和可預防的，為產生變革性影響提供了機會； c，代表臨床需求顯著未得到滿足的領域，因為目前可用的藥物通常價格昂貴，並且主要治療症狀，通常會導致疾病進展，並且隨著時間的推移，醫療干預措施的成本也會更高。

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.

其次是治療情況。我們對心臟代謝疾病，特別是糖尿病的關注，為大量護理成本負擔高昂的患者群體提供了機會，促使衛生系統和付款人採取行動的緊迫性。經過與付款人一年多的交談，並得到眾多第三方研究的驗證，隨著疾病患病率持續增長和成本不斷上升，糖尿病是重中之重。

Meanwhile, we're not seeing significant improvements in patient outcomes. Furthermore, current diabetes treatment guidelines already calls for behavior change as the foundation of treatment. We've been stating in recent updates that digital health interventions may be useful as an adjunct to standard of care to improve diabetes management.

與此同時，我們沒有看到患者治療效果有顯著改善。此外，當前的糖尿病治療指南已經呼籲將行為改變作為治療的基礎。我們在最近的更新中一直指出，數字健康干預措施可能有助於作為護理標準的輔助手段，以改善糖尿病管理。

We believe this will help with provider adoption as we don't need to change ideas about treatments 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 PDT in the diabetes indication.

我們相信這將有助於提供者採用，因為我們不需要改變關於治療或其提供方式的想法。此外，大多數藥物都表明與行為改變結合使用，我們相信這可以在糖尿病適應症中更自然、無縫地引入和進一步採用 PDT。

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 at 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.

第三是我們的關鍵試驗中使用的臨床終點的重要性。 A1C 血紅蛋白降低不僅是醫療服務提供者和付款人普遍接受的 2 型糖尿病臨床終點，而且也被廣泛接受作為糖尿病患者未來事件的指標。如您所知，相同的終點也用於藥物試驗中，我們的探索性終點收集了廣泛的其他健康結果指標的數據，為我們的 PDT 對健康的影響提供了進一步的臨床證據。最初的健康經濟數據顯示，使用我們的療法可以抵消潛在的成本。

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 cost 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.

最後，我們目前開發的 PDT 平台旨在具有廣泛的實用性，並能夠在多種相關疾病狀態下快速擴展。這種快速擴張的潛力源於這樣一個事實：對於大多數心臟代謝狀況來說，潛在的根成本行為基本上是相同的。因此，我們的平台提供的治療這些疾病的行為健康干預措施也基本相同。這與傳統的藥物治療方法有根本的不同，在傳統的藥物治療方法中，治療不同疾病的產品通常具有獨特的作用機制。

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.

我現在回顧一下我們今年第一季度取得的成就。我們在第一季度採取了多項行動來增強我們的財務狀況並確保公司的長期成功。其中包括減少兵力、採取其他節省成本的措施以及 4 月份私募 650 萬美元。

Combined, these measures were targeted to extend our cash runway towards 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 BT-001, as well as the potential BD partnership and/or a royalty monetization transaction.

綜合起來，這些措施的目標是在 9 月底之前延長我們的現金跑道，使我們有可能達到幾個重要的里程碑，我們預計這些里程碑將進一步大幅增強我們的財務狀況。其中包括 BT-001 可能獲得 FDA 授權，以及潛在的 BD 合作夥伴關係和/或特許權使用費貨幣化交易。

Throughout the first quarter of this year, we had multiple rounds of interactions with the FDA regarding our de novo submission. 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.

今年第一季度，我們就我們的從頭提交事宜與 FDA 進行了多輪互動。我們在上次財報電話會議上強調了作為從頭流程的典型部分收到的額外信息請求，並表示我們預計將在 4 月中旬之前向 FDA 做出回應。

We're happy to report that we submitted our response on April 17 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.

我們很高興地報告，我們已於 4 月 17 日提交了回复，該機構確認審核正在進行中。我們相信我們有望在今年年中收到 FDA 的決定。

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. Signed 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 pre-authorization information exchange meetings.

我們在 BT-001 潛在商業化的準備工作中也取得了實質性進展。特別是在上個季度，我們填補了關鍵的領導職位，包括聘請了營銷主管和醫療事務主管，兩人都為團隊帶來了豐富的心臟代謝專業知識。簽署了一份中心和分銷服務合同，並以越來越多的證據為基礎，我們在研究生醫學上發表了心臟代謝健康大會的摘要，強調了我們的主要終點結果。在3月底的管理醫療藥學學會（Academy of Managed Care Pharmacy）或AMCP會議上，我們與付款人進行了良好的互動，並開始了正式的預授權信息交流會議。

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.

儘管我們的現實世界證據研究的力度減少並導致註冊速度放緩，但我們很高興地報告說，我們已經註冊了近 75% 的目標參與者，並預計在今年第三季度末完成註冊。然後，我們預計將在今年第四季度分享第一個數據集。

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. Related, we recently submitted an abstract describing our LivVita study results for presentation at the European Association for the Study of the Liver or EASL's Annual Congress. EASL is a leading professional society and their clinical practice guidelines informed 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. Alkhouri, the PI for the study, will be presenting the poster.

最後，我們預計將在今年第三季度完成向 FDA 提交用於治療肝病的突破性設備指定的申請。相關的是，我們最近提交了一份摘要，描述了我們的 LivVita 研究結果，以便在歐洲肝臟研究協會或 EASL 年度大會上展示。 EASL 是一家領先的專業協會，其臨床實踐指南為全球 NAFLD 和 NASH 的護理標準提供了參考。我們的摘要在 6 月於維也納舉行的活動中被接受用於海報展示，該研究的 PI Alkhouri 博士將展示海報。

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.

在過去的幾個月裡，我們對業務進行了部分困難但必要的改變。因此，我相信我們的資本效率極高，同時保持著大力推進 BT-001 潛在商業化的能力，我們預計在收到 FDA 決定後的幾個月內開始商業化。

Diane will now share more detail on our progress. Diane?

黛安現在將分享有關我們進展的更多細節。黛安？

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 interest and 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 workstreams to complete our pre-authorization information exchange or PIE value story that we have now begun to use in our first payer meeting as Frank mentioned.

謝謝，弗蘭克。我很高興能夠為我們不斷發展的商業組織增添兩位營銷和醫療事務方面的主要領導者，他們共同帶來了 40 多年的心臟代謝疾病、興趣和經驗。我們的市場准入工作仍在繼續，我們很高興整合了我們的付款人信息、付款人研究、健康經濟模型以及基於價值的協議工作流，以完成我們現在已經開始使用的預授權信息交換或 PIE 價值故事正如弗蘭克提到的，在我們的第一次付款人會議上。

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 PDTs 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.

通過最近舉行的 AMCP 會議上的小組討論和與付款人的對話，我想分享以下要點。第一，付款人開始將 PDT 與其他​​數字療法區分開來。換句話說，那些獲得 FDA 授權的產品與那些未經 FDA 授權的產品。第二，付款人認為通過 2023 年《獲得處方數字治療法案》法案獲得醫療保險承保的潛力是準備承保 PDT 的信號。最後，付款人開始定義審查處方數字療法的途徑和流程。

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 program.

自 AMCP 以來，我們已經與我們的目標名單上的付款人進行了幾次會議，並且隨著我們在 FDA 潛在授權方面取得進展，我們對早期討論感到鼓舞。退伍軍人事務部或 VA 是我們有針對性的啟動戰略的重要組成部分。事實上，退伍軍人管理局的一個站點目前正在將患者納入我們的現實世界證據計劃。

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.

我們最近完成了一項研究，以更多地了解患者群體和參與模式。 VA 分為 18 個退伍軍人綜合服務網絡或 VISN。採訪中的見解表明，我們採取雙重戰略方法，與國家層面的冠軍一起開展工作，同時推動當地 VISN 層面的宣傳。

Key summary points from the study are as follows: the concept of a cognitive behavioral therapy or CBT-based treatment path 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.

該研究的要點總結如下：認知行為療法或基於 CBT 的糖尿病治療路徑的概念受到廣泛歡迎。在考慮行為數字療法與藥物療法相關的不良事件時，藥房決策者對 BT-001 強大的安全性做出了積極反應。他們還認為這對藥品預算沒有負面影響。

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 guideline as an individualized diabetes self-management education treatment tailored to a patient's preferences, learning needs, and abilities.

藥房領導者同意 BT-001 可用於患者整個糖尿病進展的任何階段，但認為應儘早使用。他們一致認為，BT-001 將符合當前的 VA 臨床實踐指南，作為根據患者偏好、學習需求和能力量身定制的個性化糖尿病自我管理教育治療方法。

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.

最後，在成功治療糖尿病的措施中，HbA1C 的降低和門診就診次數被提及最多。我們期待在與國家層面的主要支持者舉行會議時獲取這些寶貴的見解，同時制定我們的 VISN 級覆蓋方法。

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.

隨著我們完善市場進入計劃，我們推出的第一階段將重點關注繼續努力擴大付款人的覆蓋範圍。受保障的生活將是我們成功的關鍵指標和決定因素。我們預計在 FDA 授權後與付款人舉行後續會議，並且在此過程中我們將優先僱用我們的現場付款人團隊。

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 matched 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.

我們知道，市場上擁有供應商需求和臨床冠軍也至關重要。隨著我們進一步完善與去年第四季度進行的患者索賠分析相匹配的 50 個衛生系統列表，衛生系統特徵仍在繼續。我們的目標是確定那些具有創新性且更有可能採用 BT-001 的衛生系統。

Indicators include the ability to influence provider network, 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 payers' willingness to review for coverage via PIE meetings, we will prioritize health systems mapped to these payers.

指標包括影響提供者網絡的能力、參與基於價值的合同以及關注人口健康研究或糖尿病或其他大量人口疾病的舉措。當我們提高認識並加快目標付款人通過 PIE 會議審查承保範圍的意願時，我們將優先考慮與這些付款人相對應的衛生系統。

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.

我們的計劃是在特定地區啟動現場團隊建設，在這些地區，我們看到付款人和提供商在進入重點區域市場方面出現了積極勢頭。這代表了我們以負責任、高效的方式管理資源的深思熟慮的方法。

With regards to provider engagement, in the first quarter, we also onboarded key opinion leader advisers 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 BT-001 about their enthusiasm for this novel therapeutic and the clinical data that supports it.

在提供商參與方面，第一季度，我們還聘請了關鍵意見領袖顧問，他們將指導我們的營銷工作。收集到的早期見解將為我們更廣泛的研究提供信息。我很高興聽到從未接觸過或沒有使用過 BT-001 的執業臨床專家表達了他們對這種新型療法的熱情以及支持它的臨床數據。

Advisers 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 BT-001 may offset costs of expensive pharmacotherapy. They recognized 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.

顧問們重視與他們在藥物試驗中預期的臨床終點相匹配的 HbA1C 降低。他們對健康經濟數據感到鼓舞，BT-001 可能會抵消昂貴的藥物治療費用。他們認識到這裡令人興奮的創新是向行為療法的轉變，這可能會增加患者改變的機會，而不僅僅是單獨監測可以提高人們對食物選擇對血糖影響的認識。與藥物一樣，在電子處方工作流程中提供 BT-001 處方至關重要。

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.

最後，我們很高興地報告，我們已經與我們的分銷合作夥伴 Phil 合作，利用其 PhilRx 患者訪問平台來改善處方的獲取，簡化患者的處方體驗，並管理藥房和醫療福利流程。 Phil 的技術解決方案為像我們這樣的公司提供了 PDT 領域所需的能力，並且它已經在當今市售的多種處方數字療法中得到實施。

Mark Heinen, our Chief Financial Officer, will now review our first-quarter 2023 financial results. Mark?

我們的首席財務官 Mark Heinen 現在將審查我們 2023 年第一季度的財務業績。標記？

Thank you, Diane. I'll begin by discussing our operating expenses for the first quarter of 2023. Our research and development expenses were $3.4 million for the quarter ended March 31, 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.

謝謝你，黛安。我首先討論我們 2023 年第一季度的運營費用。截至 2023 年 3 月 31 日的季度，我們的研發費用為 340 萬美元，而 2022 年同期為 370 萬美元。減少的主要原因是資本化軟件開發成本的增加被臨床研究成本的減少所抵消。

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.

截至 2023 年 3 月 31 日的季度銷售和營銷費用為 210 萬美元，而去年同期為 200 萬美元。這一增長主要與我們的商業準備活動相關的人員相關成本增加有關，但部分被現實世界證據相關費用的減少所抵消。

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-related costs.

截至 2023 年 3 月 31 日的季度的一般和管理費用為 340 萬美元，而 2022 年同期為 360 萬美元。這一下降主要與商業保險成本下降有關，但在一定程度上被人事相關成本的增加所抵消。

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 secured term loan agreement with Hercules Capital in the second quarter of 2022.

截至 2023 年 3 月 31 日的季度利息支出為 40 萬美元，而去年同期為 30 萬美元。這一增長主要是由於該公司在 2022 年第二季度根據與 Hercules Capital 的擔保定期貸款協議額外借入了 500 萬美元。

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.

截至 2023 年 3 月 31 日的季度淨虧損為 940 萬美元，而去年同期為 970 萬美元。按每股計算，淨虧損為 0.39 美元，而去年為 0.41 美元。每股虧損的下降與加權平均流通股的增加和淨虧損的下降有關。

Moving to our balance sheet, cash and cash equivalents were $6.1 million on March 31, 2023, compared to $15.7 million on December 31, 2022. In April 2023, we completed a private placement for gross proceeds of $6.5 million.

從我們的資產負債表來看，2023 年 3 月 31 日的現金和現金等價物為 610 萬美元，而 2022 年 12 月 31 日為 1,570 萬美元。2023 年 4 月，我們完成了私募，總收益為 650 萬美元。

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.

按預計，考慮到私募，第一季度末現金和現金等價物為 1,260 萬美元。我們第一季度的現金消耗包括一些一次性費用，總計約 160 萬美元，其中包括與我們最近的融資相關的費用、Hercules 債務融資下的本金支付等。

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 July and principal payments for up to six months.

然而，由於重組和其他成本節約舉措，我們的現金消耗現已顯著減少。這些舉措包括修改與 Hercules 的定期貸款協議，其中規定了 7 月的還款期和最長六個月的本金還款期。

The cost savings initiatives and delay in principal payments and proceeds from the private placement are expected to extend our cash runway towards 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.

成本節約舉措以及本金支付和私募收益的延遲預計將在第三季度末延長我們的現金跑道，使我們有可能實現幾個關鍵里程碑，包括 FDA 授權、業務開發交易和/或版稅貨幣化交易。

With that, I'll turn the call back over to Frank for some closing comments. Frank?

這樣，我會將電話轉回給弗蘭克，以徵求一些結束語。坦率？

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-share dilutive financings, such as a royalty monetization transaction.

謝謝你，馬克。在結束之前，我想回到我們的融資策略。正如我之前分享的，我們正在推行三層戰略，包括基於資本市場的融資、業務開發和結構化非股權稀釋融資，例如特許權使用費貨幣化交易。

While we have executed on one element of the strategy with our private placement, we recognize our cash resources need to be further enhanced. 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.

雖然我們已經通過私募執行了該戰略的一項要素，但我們認識到我們的現金資源需要進一步增強。正如馬克提到的，通過採取行動擴大我們的現金跑道，我們相信我們有足夠的時間來實現對我們成功至關重要的一個或幾個里程碑。每個里程碑要么是進一步融資機會的催化劑，要么直接導致有意義的現金注入，或兩者兼而有之。

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.

值得注意的是，當我們完成最近的私募時，我們本來可以進行更大的交易，但特意決定以更好的條件進行更小的交易，因為我們認為這對於公司和股東來說是正確的事情。我們還相信，這可以更好地幫助我們取得長期成功，並反映出我們對融資戰略其他要素取得成果的信心。

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. Until we know where we come out on these elements, we're operating on a highly cost efficient basis.

自私募以來，我們在各種業務發展討論中取得了重大進展，並對我們繼續實現融資戰略若干要素的能力感到樂觀。在我們知道這些要素的結果之前，我們都是在高度成本效益的基礎上運營的。

In closing, the industry is at an inflection point. Whether it is the advancement of the Access to Prescription Digital Therapeutics 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.

最後，該行業正處於拐點。無論是處方數字治療的進步，還是付款人對 PDT 的興趣不斷增加，該行業正在以對我們有利的方式發展。我們相信我們處於取得成功的有利位置。

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.

在很大程度上，由於我們專注於以 2 型糖尿病為主要適應症的心臟代謝疾病，我們預計我們的推出動態將與之前 PDT 推出中觀察到的情況有所不同。我們期待著將我們突破性的治療方法帶給急需的醫療服務提供者和患者。

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 question. Thank you.

最後，我想再次感謝整個 Better Therapeutics 團隊每天對患者表現出的堅定不移的熱情和承諾。現在我們準備好回答你的問題了。謝謝。

Thank you. At this time, we will conduct a question-and-answer session. (Operator Instructions)

謝謝。這時候，我們將進行問答環節。 （操作員說明）

Thomas Flaten, Lake Street Capital Markets.

托馬斯·弗拉頓（Thomas Flaten），湖街資本市場。

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've put in?

大家，早安。感謝您提出問題。弗蘭克，我想知道您是否可以對與 FDA 的對話發表評論。他們是否對您所提供的答复的充分性提供了任何提示？

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 submission and that the review continues to progress. They further gave us an indication that led us to believe that we are now on the final 90 days of the review. That is going back to the submission date, which was April 17.

嘿，托馬斯，早上好。感謝您的提問。我們無法評論 FDA 對我們的具體回應。但他們確實告訴我們，他們接受了我們提交的材料，並且審核仍在繼續進行。他們進一步向我們提供了一個指示，使我們相信我們現在正處於審核的最後 90 天。這要追溯到提交日期，即 4 月 17 日。

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 how many patients will 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?

知道了。並祝賀您報名參加現實世界研究。我很好奇，您是否可以為我們預覽一下，有多少患者會看到，隨訪時間段，當我們進入第四季度時我們可能會看到什麼類型的終點，您準備好宣布其中的一些內容數據？

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?

是的。我們可以在這裡添加一些預期的顏色。我想邀請馬克·伯曼加入對話。馬克，你想對此發表評論嗎？

Happy to. Thanks, Frank, and good morning, Thomas. So the real-world evidence program, as you know, it's going to enroll approximately 1,000 patients across the multisite 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.

高興。謝謝，弗蘭克，早上好，托馬斯。因此，如您所知，現實世界證據計劃將在多地點研究中招募大約 1,000 名患者。正如我們所提到的，該研究的註冊人數大約已完成四分之三，預計到第三季度末將全部註冊。

In Q4, we will release interim results. These will be our results of six-months duration front, so change from baseline. We'll focus on A1C change at that time, and we're going to release contingent on having sufficient power.

第四季度，我們將發布中期業績。這些將是我們六個月持續時間的結果，因此與基線相比有所變化。到時候我們會重點關注A1C的變化，有足夠的力量我們就會釋放隊伍。

So obviously, this won't be the full set of patients as of the interim results. And we'll make sure that we release results when we have a sample size that that gives us sufficient power. And therefore, sufficient confidence in the results that we'll share.

顯然，這並不是中期結果的全部患者。當我們擁有足夠的樣本量時，我們將確保發布結果。因此，我們對我們將分享的結果有足夠的信心。

And just a follow-up on that. And will those data then be rolled into your dossier that you used in discussions with payers, or will you wait for the study to be complete?

這只是後續行動。然後，這些數據會被納入您與付款人討論時使用的檔案中，還是會等待研究完成？

Yes. It'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 it's going to be super helpful in the long run for providers and in the long run, potentially for payers, it's not necessary for initial commercial launch or initial discussions with payers. So we are not planning to wait on this data.

是的。這是一個很好的問題。我先開始，然後我們可以將其交給弗蘭克或黛安對此發表評論。因此，我們相信，這些數據雖然從長遠來看對提供商和付款人來說非常有幫助，但對於最初的商業啟動或與付款人的初步討論來說沒有必要。所以我們不打算等待這些數據。

Correct, Mark. This is Diane. Good morning, Thomas. I'll just add to say that of course, a 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 of course, any data that becomes available, we'll look to utilize.

正確，馬克。這是黛安。早上好，托馬斯。我想補充一點，當然，現實世界的證據研究對於付款人來說總是很重要。但即使從我們就基於價值的協議進行的一些早期對話來看，人們也真正認識到行為改變很可能會改變患者的臨床結果。因此，我們與付款人的很多對話都重點關注參與度指標。當然，我們會利用任何可用的數據。

Thanks. I appreciate you taking the question. Thank you.

謝謝。我很感謝你提出這個問題。謝謝。

Thank you.

謝謝。

You're welcome.

不客氣。

Charles Rhyee, TD Cowen.

查爾斯·萊伊 (Charles Rhyee)，TD 考恩 (TD Cowen)。

Hi, this is Lucas on for Charles. Thanks for taking the questions. Curious to see or to hear how your conversations with health systems and providers have gone at this point, given that physicians may be harder to 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. And just maybe some detail around what you guys specifically do to maybe overcome or maybe a stigma among patients around prescription digital therapeutics?

大家好，我是查爾斯的盧卡斯。感謝您提出問題。鑑於在使用 PDT 方面醫生可能比付款人更難推銷，我很想知道或聽到您與衛生系統和提供者的對話目前進展如何。我想听聽您與醫生和衛生系統的互動，特別是在您所針對的地區，到目前為止的互動情況如何。也許只是一些關於你們具體做了什麼來克服或可能是患者對處方數字療法的恥辱的一些細節？

Yeah, good morning. Thanks for your question. I will hand it on to Diane here in a moment, but maybe just to start. You mentioned at the end a stigma that maybe -- 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.

是的，早上好。謝謝你的提問。我稍後會將其交給黛安，但也許只是開始。你最後提到了這裡的病人可能面臨的一種恥辱。我認為，這實際上是我們與您過去看到的其他 PDT 發布的不同之處之一。我們認為我們實際上並不存在這樣的問題，即我們正在與高度污名化的患者打交道。

We are dealing with type 2 diabetes with a patient population that is, a, highly prevalent, that has high cost-of-care burden associated with it, and that has high degrees of unmet medical needs. You may recall we shared earlier that only about 50% of patients that are on the standard-of-care medications do, in fact, have their blood sugar under control.

我們正在應對 2 型糖尿病，其患者群體非常普遍，與之相關的護理成本負擔很高，並且醫療需求高度未得到滿足。您可能還記得我們之前分享過，事實上，只有約 50% 接受標準護理藥物的患者的血糖得到了控制。

And these patients have been treated in the mainstream of our healthcare system by endocrinologists and primary care physicians. So we actually don't think that there's stigma around 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 that digital health interventions. So we think we're very well positioned here.

這些患者在我們的主流醫療保健系統中接受了內分泌科醫生和初級保健醫生的治療。因此，我們實際上並不認為數字健康干預措施存在恥辱。正如我在準備好的發言中所說，2 型糖尿病的治療指南不僅在最近的更新中呼籲將行為改變作為治療的基礎，而且現在實際上還提到了數字健康干預措施。所以我們認為我們在這里處於非常有利的位置。

But, Diane, maybe you can share a little bit more color of what we're hearing from providers and payers alike in the various interactions that we've had over the last few weeks.

但是，黛安，也許你可以分享我們在過去幾週的各種互動中從提供商和付款人那裡聽到的更多信息。

Yes, absolutely. Thanks, Frank, and good morning, Charles. I do think it's important to separate out on the payers and the providers. In the payers, clearly, there's more understanding for prescription digital therapeutic 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.

是的，一點沒錯。謝謝，弗蘭克，早上好，查爾斯。我確實認為區分付款人和提供者很重要。顯然，付款人對處方數字治療作為一個類別有更多的理解。我認為，你知道，弗蘭克已經說過，我們在過去 12 到 18 個月裡一直在與付款人交談，這是一個補充。

And since the beginning, 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 are 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 endpoint, A1C, which are accustomed to be understood in that clinical setting in drug trials different than symptom alleviation types of endpoints from safety and efficacy data; and also engagement during treatment.

從一開始，團隊就一直在詢問他們在審查 BT-001 和考慮覆蓋範圍時需要考慮什麼。我們查看了這段時間我們聽到的所有內容的清單，我們準備好滿足付款人的期望。其中包括： FDA 授權；具有足夠規模和受控的試驗設計；不同的人群，我知道付款人對此非常感激；臨床終點 A1C，通常在藥物試驗的臨床環境中理解，與安全性和有效性數據中症狀緩解類型的終點不同；以及治療期間的參與度。

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.

值得注意的重要事情之一是，付款人對處方數字療法的差異有了更多的認識。因此，雖然將其視為一個類別很重要，但深入研究也很重要。因此，弗蘭克指出，其中一些差異可能與我們的產品以及我們與其他處方數字療法相比的遊戲空間有關。

But 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(k) 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.

但同樣重要的是要了解我們也在尋求治療索賠。因此，我們提供的證據水平比付款人通常從 510(k) 類型的設備中理解的證據要可靠得多。因此，我們必須指出其中的一些差異，付款人也開始認識到，從一種 PDT 到另一種 PDT 的證據水平作為其審查的一部分非常重要。

On the provider side, I'm actually quite pleased. It was really important to start engaging provider to -- I think it's important to note 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.

在提供商方面，我實際上非常滿意。開始讓提供商參與進來非常重要——我認為值得注意的是，他們不太了解 PDT 作為一個類別。因此，當我們與醫療服務提供者交談時，我們專門談論我們對 2 型糖尿病的治療，他們不一定具備其他疾病領域的 PDT 知識。

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. And as they're exposed to BT-001 and all of the clinical data that supports it, they continue to engage to inform our broader research.

由於我們已經聘請了一些關鍵意見領袖顧問，他們也擔任大型製藥公司和其他設備公司的顧問，我對他們的反應非常滿意。當他們接觸 BT-001 以及支持它的所有臨床數據時，他們會繼續參與為我們更廣泛的研究提供信息。

And 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 into 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 our own and really encourages, makes sure we're publishing, which, of course, we've advanced to that work.

在這裡，我想說的是，我們的早期研究真正指出的是圍繞臨床終點的這個值，與他們在藥物試驗中的預期相匹配，在我們的例子中，A1C 的降低。即使不是衛生經濟數據方面的專家，他們也了解昂貴的藥物治療和系統管理對患者造成的高昂影響，以及從一種藥物升級到另一種藥物的感覺。因此，他們受到健康經濟數據和我們自己的數據的鼓舞，並真正鼓勵並確保我們正在發表，當然，我們已經推進了這項工作。

And they do see this as exciting. Right now, it's been thought of, monitoring. Really it's been important especially as innovation in monitoring has continued to improve and increasing awareness of patient's blood glucose. The 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 progressive disease from one medication to another.

他們確實認為這令人興奮。現在就想到了，監控。事實上，這一點非常重要，尤其是隨著監測方面的創新不斷改善並提高了患者對血糖的認識。他們每天所做的選擇非常重要。他們確實認為這增加了患者做出真正改變並真正改善通常只是從一種藥物到另一種藥物的進行性疾病的機會。

So at this point, we're really encouraged by the conversations that we're having with advisors who have not had experiences to our therapy.

因此，在這一點上，我們與沒有接受我們治療經驗的顧問進行的對話確實讓我們感到鼓舞。

Okay. Yeah, it's encouraging. And then can you guys update us on 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.

好的。是的，這令人鼓舞。那麼你們能否向我們介紹一下使用收集的結果和參與度數據以及在平台中構建個性化功能方面取得的進展？據我所知，你們希望在 BT-001 發佈時看到這些功能嵌入到平台中。

Now that we're getting closer to commercial launch, could you guys give us an update on what these capabilities around personalization of treatment and experience might look like?

現在我們越來越接近商業發布，你們能給我們介紹一下這些關於個性化治療和體驗的功能的最新情況嗎？

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 controlled trial, does already include a high degree of personalization. The treatment algorithms that are AI powered dynamically adjust the treatment patient intensity to each individual patients.

讓我開始吧，我也會請馬克·伯曼插話。首先要認識到的是，正如我們的隨機對照試驗中所使用的那樣，該產品確實已經包含了高度的個性化。由人工智能驅動的治療算法可以動態調整每個患者的治療強度。

One of the features of digital therapeutics in general is that they are subject to continuous improvement based on the very data that the use of these therapies generate. 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.

一般來說，數字療法的特點之一是，它們可以根據使用這些療法產生的數據進行持續改進。當然，我們還做出了額外的改進。隨著越來越多的數據被收集，這種發展將持續下去。

I think the engagement data is the data we've shared previously from our randomized controlled trial. And there, I think the numbers were exceptionally strong. We saw 81% of patients still engaged with our PDT after six months. On average, spending six minutes in app per day. So those were really exceptionally high engagement metrics. And the NPS scores as a measure for patient satisfaction was also exceptionally high, with an NPS score of 61.

我認為參與數據是我們之前從隨機對照試驗中分享的數據。我認為那裡的數字異常強勁。我們發現 81% 的患者在六個月後仍在接受我們的 PDT。平均每天在應用程序中花費六分鐘。所以這些確實是非常高的參與度指標。作為衡量患者滿意度的 NPS 得分也非常高，NPS 得分為 61。

And I think, 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.

當然，我認為我們目前在現實世界的證據計劃中繼續收集相關數據。一旦我們發布下一批數據，我們當然也會再次包含參與度數據。

And as a last point, I would say you may recall the engagement data that we released on our pilot study in liver disease, the LivVita study where we evaluate the utility of our platform in NASH and NAFLD had even better engagement metrics than what we saw in the randomized trial. Though, I will say it was also a smaller sample size.

最後一點，我想說，您可能還記得我們在肝病試點研究、LivVita 研究中發布的參與度數據，我們評估了我們的平台在 NASH 和 NAFLD 中的效用，其參與度指標甚至比我們看到的更好在隨機試驗中。不過，我會說這也是一個較小的樣本量。

Mark, do you want to comment a bit more on sort of the level of personalization that's embedded in our product?

馬克，您想對我們產品中嵌入的個性化程度進行更多評論嗎？

Happy to, Frank. I mean, I think you did a wonderful job of summarizing that. Again, Lucas, the product that was tested within the BT-001 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.

很高興，弗蘭克。我的意思是，我認為你總結得非常出色。 Lucas 再次強調，在 BT-001 樞軸中測試的產品具有高度的個性化。當然，通過每一次研究產品的機會，每一次將其展示給另一組患者的機會，我們獲得了有價值的可用性數據、有價值的參與數據、有價值的滿意度數據，並且我們對產品進行了許多改進這將進入商業推出的產品中。

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 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.

但個性化的核心租戶將保持原樣，因為它們運作良好。正如弗蘭克提到的，這些個性化元素實際上包括任何患者與平台互動的能力，無論他們當前的行為成就或激活狀態如何，如果你願意的話。指導患者行為改變的算法確實對患者當前的狀態做出了反應。當他們以自己獨特的速度前進時，嘗試以適合他們的速度前進，以做出行為改變，這不僅是有效的，而且是可持續的，我們看到這在很大程度上反映在我們的數據。

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, you know, 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.

當我們更深入地研究數據時，我們發現無論患者身在何處，行為都在逐漸轉變。我們看到這些在六個月內取得了進展，但我們還沒有看到變化程度的峰值，這表明我們已經創建了一種與持續行為變化更一致的模式。認知行為療法的其他要素（包括課程）包括個性化要素。

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.

有大量的技能認識到，我們試圖改變的行為確實代表了非常廣泛的飲食和其他生活方式以及自我保健行為。患者需要掌握多種技能才能有效。該平台允許患者根據對他們有益的不同技能來個性化他們的體驗。

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.

此外，如果您願意的話，計算機生成的反饋在整個解決方案中無處不在。因此，從治療一開始，患者就會了解他們的參與度、行為改變、生物識別數據是否表明他們將走上從解決方案中受益的軌道，並指導患者是否受益而不是旨在幫助克服變革障礙的額外內容、額外活動。

So there is a rich -- I'll summarize it saying 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 our refinements based on the usability data that we have.

因此，我總結一下，有一套豐富的個性化功能。我們基本上已經測試了所有這些。我們將在商業產品中發布的是基於我們擁有的可用性數據的改進。

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.

我想我會回應弗蘭克所說的。我的意思是，我們對有機會推出該產品感到非常興奮，希望能在商業領域推出。因為很明顯，隨著我們獲得更多的患者群體，這些數據確實非常寶貴，可以讓我們進一步完善驅動患者體驗的功能集和算法。

Great. Thanks for taking for the questions.

偉大的。感謝您提出問題。

Keay Nakae, Chardan.

凱·中江，查丹。

Yeah, thanks. My question is on the BD side, the potential commercial partner. I guess from your perspective, again, given the kind of the early history of PDTs partnering for commercialization, what are you really looking for in an ideal partner?

是的，謝謝。我的問題是關於BD方面的，即潛在的商業合作夥伴。我想，再次從您的角度來看，考慮到 PDT 商業化合作的早期歷史，您真正在理想的合作夥伴中尋找什麼？

And I guess maybe specific to diabetes, as we've seen at least on the device side, there's a lot of post-sale handholding required for patients with this disease. So how important is that? Thanks.

我想也許是糖尿病特有的，正如我們至少在設備方面所看到的那樣，患有這種疾病的患者需要大量的售後指導。那麼這有多重要呢？謝謝。

Thanks, Keay, for your great question. Good morning. So on the partnering side, as I mentioned on a slide our earnings call, that we have multiple discussions that we're currently entertaining with different types of companies that span the gamut, from pharma to medical device through tech. And the nature of these discussions is in each of these cases, it's slightly different. And we could benefit from a potential partnership in multiple ways.

謝謝基伊提出的好問題。早上好。因此，在合作方面，正如我在收益電話會議的幻燈片中提到的那樣，我們目前正在與涵蓋各個領域的不同類型的公司進行多次討論，從製藥到醫療設備再到科技。這些討論的性質在每種情況下都略有不同。我們可以通過多種方式從潛在的合作夥伴關係中受益。

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 then with a partner, we would be able to progress faster.

您可以想像一種合作夥伴關係，它可以支持在美國的商業發布，並幫助我們在美國市場成功地將 PDT 商業化。您可以單獨看到一種合作夥伴關係，該合作夥伴關係可能支持擴大我們的地理覆蓋範圍，並幫助我們在美國以外的市場將我們的 PDT 商業化，而我們目前確實無法自己做到這一點。第三，您可以想像建立合作夥伴關係來支持我們產品線的擴展，這意味著將業務範圍從 2 型糖尿病擴展到其他心臟代謝疾病，特別是那些我們已經有概念證明的疾病。然後有了合作夥伴，我們就能進步得更快。

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, it's different depending on who we're talking to.

作為第四個例子，您還可以看到將我們的 PDT 與某些其他醫療設備結合起來的機會。因此，這是一個非常廣泛的領域，對我們來說，價值主張會根據我們的談話對象而有所不同。

Anything that is diabetes disease related, that's important from your perspective.

從您的角度來看，任何與糖尿病相關的疾病都很重要。

Say it again, sorry. I could not hear you.

再說一遍，對不起。我聽不到你說話。

Anything that is diabetes disease related, it's important that partner understands that you're looking for from your end?

任何與糖尿病相關的疾病，重要的是合作夥伴要了解您正在尋找的目標？

Yes. I mean, 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 it generates revenue on its own. So that's maybe one key point here.

是的。我的意思是，我們不——我認為這裡的基本點是我們不將 PDT 視為藥物的輔助藥物。我們將 PDT 視為一種獨立的產品，可以自行創造價值並自行產生收入。這可能是這裡的一個關鍵點。

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 sort of sales and marketing, of course, that would be beneficial.

當然，在 2 型糖尿病或其他心臟代謝疾病方面的經驗，取決於合作夥伴關係是專注於支持我們在 2 型糖尿病領域的推出，還是專注於擴大我們的產品線、治療領域的專業知識和有助於市場准入的能力、醫療事務，以及最終的銷售和營銷，當然，這將是有益的。

And I don't know, Diane, anything that you would want to add from your standpoint?

我不知道，黛安，從你的角度來看，你還想補充什麼嗎？

Yes. Thanks, Frank. So we do see this as a revenue generating treatment and not necessarily specific to any one drug. And we feel that capturing the 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 source. You know there's a lot of digital therapeutics or digital solutions that are certainly advancing amongst many players in the pharmacotherapy, the devices space, or 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.

是的。謝謝，弗蘭克。因此，我們確實將其視為一種創收療法，並不一定特定於任何一種藥物。我們認為捕捉藥物依從性的特徵對於我們的技術很重要。我認為真正重要的是要理解，這不是任何來源的配套應用程序。您知道，有許多數字療法或數字解決方案在藥物治療、設備領域甚至消費領域的許多參與者中肯定正在進步。所以我認為這是一個重要的區別，我們將其視為一種可以創收的藥物治療方法。

And I think what's important to understand as well, I heard the comment, Keay, with regards to handholding with patients is 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 any additional kind of human interaction through that process.

我認為理解這一點也很重要，我聽到了關於與患者握手的評論，基伊，我們對我們在關鍵試驗中已經看到的數據感到非常興奮，其參與程度是患者沒有達到的水平必然會激勵使用該應用程序。他們沒有動力使用該應用程序，也沒有通過該過程進行任何其他類型的人際互動。

But we do know from conversations now, for example, with payers and with providers, the importance of ensuring the education of diabetes. And there's 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 the 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.

但我們現在確實從與付款人和提供者的對話中知道確保糖尿病教育的重要性。有些教育工作者已經成為糖尿病患者治療支持和現有糖尿病疾病管理的一部分。因此，令人鼓舞的是，付款人和提供者共同發出信號，表明這種療法已經成為該治療途徑的一部分。因此，我們對與 2 型糖尿病相關的這些細節感到鼓舞。

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 -- 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.

我只想澄清最後一點。正如 Diane 所說，我們並不將 PDT 視為配套應用程序，而是將其視為獨立產品。但這並不是說將我們的 PDT 與合作夥伴可能在市場上擁有的藥物療法一起使用；它顯然可以產生額外的好處。我的意思是，我們已經在隨機對照試驗中證明，我們的 PDT 與標準護理相結合可以產生更好的結果，無論是在安全性還是有效性方面都比單獨使用標準護理更好。

You could further think about avenues where the pairing of a PDT with a pharmaco drug might result in better medication adherence because you have a platform that allows you to engage with the patient on a daily basis. So I just would say that while we view our PDT as having independent value, there is an incremental value proposition that could be realized in cases where a partner might have existing pharmacotherapies on the market.

您可以進一步考慮將 PDT 與藥物配對可能會導致更好的藥物依從性的途徑，因為您有一個平台可以讓您每天與患者接觸。因此，我只想說，雖然我們認為我們的 PDT 具有獨立價值，但如果合作夥伴可能在市場上擁有現有的藥物療法，則可以實現增量價值主張。

Okay. Well, thank you for answering my questions.

好的。嗯，謝謝你回答我的問題。

Rahul Rakhit, LifeSci Capital.

拉胡爾·拉希特（Rahul Rakhit），LifeSci Capital。

Hey, good morning, guys. Look, I know I've asked this before, but given that you guys are further honing in on commercial strategy ahead of the launch, I was just thinking how you think about positioning BT-001 to physicians?

嘿，早上好，伙計們。聽著，我知道我以前問過這個問題，但考慮到你們在推出前進一步磨練商業策略，我只是在想你們如何看待將 BT-001 定位給醫生？

And obviously current treatment guidelines call for behavioral therapy as a first-line therapy. But we saw it in pivotal study that you guys treated patients with pretty advanced disease and saw compelling changes being made to their medication usage. So just as you guys 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 to pick one -- of the spectrum do you intend to focus on?

顯然，當前的治療指南要求將行為療法作為一線療法。但我們在關鍵研究中看到，你們治療了患有相當晚期疾病的患者，並看到他們的藥物使用發生了引人注目的變化。因此，正當你們開始組建銷售隊伍並為與內科醫生和 PCP 進行介紹性對話做好準備時，我猜想您打算關注哪一側（如果您要選擇一側）？

Thank you for your question, Rahul. 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 it maybe for the next call when we are closer to the actual launch.

謝謝你的提問，拉胡爾。早上好。我想說，現在對此進行詳細評論可能有點為時過早，我們可能會在接近實際發佈時為下一次電話會議保留其中的一些內容。

But, Diane, maybe you want to provide already some high-level thinking around the question that Rahul just asked.

但是，黛安，也許你想圍繞拉胡爾剛才提出的問題提供一些高層次的思考。

Sure. Rahul, good morning. I love this topic. And it's important to recognize that as we've on-boarded advisers, this is really a lot of, first and foremost, the set of work that they are helping to guide us with. So their early insight, how they see potential for positioning, having us make sure we carve out right at different place in the market because this therapy is so differentiated. Then again, the many companion apps that are out there, solutions in the wellness space, other types of therapies.

當然。拉胡爾，早上好。我喜歡這個話題。重要的是要認識到，由於我們聘請了顧問，因此首先也是最重要的是，他們正在幫助指導我們完成很多工作。因此，他們的早期洞察力，他們如何看待定位的潛力，讓我們確保我們在市場的不同位置做出正確的選擇，因為這種療法是如此差異化。再說一遍，有許多配套應用程序、健康領域的解決方案以及其他類型的療法。

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 a little more to advance there before we talk more in depth, but certainly ongoing work that we're doing at the moment.

所以現在說還為時過早。但就在本週，我能夠與提供商就一些潛在的定位工作進行接觸，這讓我感到鼓舞。因此，在我們進行更深入的討論之前，還需要進一步推進，但我們目前正在做的工作肯定是持續進行的。

Got it. No, I appreciate that. Look, I know you guys are heads down focused on a future launch. But given that you have some of these other plans within the pipeline to develop out these assets down the road, I guess, given the size of pivotal studies in NASH, hypertension, or hyperlipidemia, I mean, I guess what are the estimates around what a pivotal trial in one of these indications might cost? What resources are needed to execute a trial like that?

知道了。不，我很欣賞這一點。聽著，我知道你們正低頭專注於未來的發布。但是，考慮到您正在製定一些其他計劃來開發這些資產，我想，考慮到 NASH、高血壓或高脂血症的關鍵研究的規模，我的意思是，我猜圍繞什麼進行了估計對這些適應症之一進行關鍵試驗可能會花費成本？執行這樣的試驗需要什麼資源？

I'll say two things, Rahul. The first one is while we have, as you know, pilot data for NASH, NAFLD, hypotension, 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, as much 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 had the eyes on the prize first to get type 2 diabetes over the line and are ready to launch.

我要說兩件事，拉胡爾。第一個是，如您所知，我們擁有 NASH、NAFLD、低血壓、高脂血症的試點數據，並且我們相信我們手頭有數據可以設計下一組關鍵試驗，但我們目前不追求這一點，同樣被擱置，只是因為我們需要將寶貴的財務資源集中在獲得 FDA 授權、推進我們的商業上市準備工作上，並真正確保我們首先著眼於讓 2 型糖尿病成功並準備啟動。

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 (technical difficulty). The moment we have financial resources. then we are going to continue those additional [explanations] to expand into other indications and initiate others. I just want to be clear that we're very focused right now on where we're spending our money and we're spending our time.

當我們擁有額外的財政資源時，正如我提到的，這可以通過多種不同的途徑來實現，我們正在追求這一點（技術難度）。當我們有財力的時候。然後我們將繼續這些額外的[解釋]以擴展到其他適應症並啟動其他適應症。我只是想明確表示，我們現在非常關注我們把錢花在哪裡、把時間花在哪裡。

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.

我認為開發 PDT 的一個吸引人的特點是，完成這些關鍵研究所需的時間和成本只是典型藥物的一小部分。

And, Mark Berman, maybe you want to just give a high-level estimate of how we think about cost and time around the pivotal trial, let's say, for NASH/NAFLD, but it equally applies actually to other indications as well.

而且，Mark Berman，也許您只想對我們如何考慮關鍵試驗的成本和時間進行高水平估計，比如說 NASH/NAFLD，但它實際上也同樣適用於其他適應症。

Yeah, I think that's right. Good morning, Rahul. So to build on Frank's comments, you recall that our initial pivotal study in 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.

是的，我認為這是對的。早上好，拉胡爾。因此，在 Frank 的評論的基礎上，您還記得我們對約 668 名患者進行的最初關鍵研究被認為是醫療設備或處方數字治療最有力的關​​鍵試驗之一。它確實作為從頭途徑的一部分作為關鍵試驗提交給 FDA。

Our anticipation and our strategy is that assuming we will get authorization for BT-001, subsequent indications are going to be filed under the 510(k) pathway because the underlying platform is substantially similar. We 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 NASH and NAFLD.

我們的預期和策略是，假設我們將獲得 BT-001 的授權，後續指示將根據 510(k) 途徑提交，因為底層平台基本相似。我們已經收集了可靠的安全數據集；該安全數據集非常強大。因此，需要建立一個新的數據集來推進特定的主張，例如，作為 NASH 和 NAFLD 的治療方法。

But because of that earlier, predicate work, the future studies are expected to be smaller than the pivotal study. Obviously, they'll be -- 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.

但由於較早的謂詞工作，未來的研究預計將小於關鍵研究。顯然，它們都是單獨供電的，因此它們將具有單獨的樣本大小，具體取決於我們希望在每個指示中看到的效果大小。

But similarly, we also -- 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 as Frank mentioned, these are -- while they would be randomized controlled trials and still robust trials there and have a fraction of the duration and a fraction of the cost than the traditional drug trial. And so as Frank mentioned also, we are really excited to commence work on those once we have resources. And at the moment, we're staying focused on BT-001.

但同樣，我們也認為，這些試驗中的大多數平均治療期約為六個月，足以證明患者按預期使用該設備時的安全性，並且足以產生有效性或功效信號以確定索賠。正如弗蘭克所提到的，這些是——雖然它們將是隨機對照試驗，並且仍然是穩健的試驗，並且與傳統藥物試驗相比，其持續時間和成本只有一小部分。正如弗蘭克也提到的，一旦我們擁有資源，我們非常高興能夠開始這些工作。目前，我們將繼續關注 BT-001。

As you asked, Rahul, specifically, what does this cost? I mean, the type 2 diabetes pivotal trial costs between $10 million and $15 million. And exponentially, that 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.

正如你所問的，拉胡爾，具體來說，這要花多少錢？我的意思是，2 型糖尿病關鍵試驗的費用在 1000 萬至 1500 萬美元之間。而且按指數計算，這個數字可能會稍微高一些，但不會高很多。我想說，它大致在同一個範圍內，更多的是在該範圍的上限。

So if you think about, these are, at the end of the day, sort of phase these studies, that data of which it's going to be used to seek additional authorizations from the FDA. Again, it's a fraction of what it would be for a new pharmacological agent.

因此，如果你想一想，歸根結底，這些研究屬於某個階段，這些數據將用於尋求 FDA 的額​​外授權。同樣，這只是新藥物的一小部分。

Got it. That's helpful. I appreciate that. And then just one more clarification question for me. I apologize if I missed it earlier. But just obviously assuming clearance and a subsequent launch earlier this year, I guess, how should we think about your incremental changes to OpEx over the next couple of quarters? Thanks.

知道了。這很有幫助。我很感激。然後再向我提出一個澄清問題。如果我之前錯過了，我深表歉意。但顯然，假設今年早些時候獲得許可並隨後推出，我想我們應該如何考慮您在接下來的幾個季度對運營支出的增量變化？謝謝。

Yes. So generally, you can expect our OpEx to continue to actually decline right now. And that's really because the impact from the restructuring is still working its way or it hasn't worked its way through our P&L in the early parts of the second quarter because that's where 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.

是的。因此，總的來說，您可以預期我們的運營支出現在實際上會繼續下降。這實際上是因為重組的影響仍在發揮作用，或者說它尚未通過我們第二季度初期的損益表發揮作用，因為那是我們實施重組的地方。然後，展望未來，您將看到運營費用繼續下降，我們將繼續在高度成本效益的基礎上運營，直到獲得額外的資金。

And as we've said multiple times here, we feel pretty optimistic that with the actions we've taken both in terms of the private 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 FDA authorization, potential PDT 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.

正如我們在這裡多次說過的那樣，我們感到非常樂觀，因為我們在幾週前完成的私募方面採取的行動以及我們已經充分擴展我們的跑道的成本控制措施實現多個里程碑，例如潛在的 FDA 授權、潛在的 PDT 交易、可能的版稅貨幣化交易。因此，我們相信，我們現在有時間將其中一項或多項完成，其中每一項要么直接產生結果，要么可能釋放獲得潛在大量額外資金的機會。

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.

但在那之前，我們將非常非常高效地運營，這意味著您將看到我們的運營費用在接下來的幾個季度繼續下降。

Thank you very much. At this time, I would like to turn the call back to Frank Karbe for closing remarks.

非常感謝。此時，我想將電話轉回給 Frank Karbe，讓其致閉幕詞。

Well, thank you very much for your interest this morning and joining us for this call. We feel very, 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 in the meantime, if you have questions, please feel free to contact us. Thank you. Bye-bye.

好的，非常感謝您今天早上的關注並參加我們的這次電話會議。我們對自己所處的位置感覺非常非常好。我希望我們能夠傳達這一點，我們期待著向您通報最新進展情況。同時，如果您有任何疑問，請隨時與我們聯繫。謝謝。再見。

Thank you for your participation in today's conference. This does conclude the program, and you may now disconnect.

感謝您參加今天的會議。這確實結束了程序，您現在可以斷開連接。