Heartbeam Inc (BEAT) 2024 Q3 法說會逐字稿

Greetings, and welcome to the HeartBeam Third Quarter 2024 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

大家好，歡迎參加 HeartBeam 2024 年第三季財務業績電話會議。（操作員指示）提醒一下，本次電話會議正在錄音。

Before we begin the formal presentation, I would like to remind everyone that statements made on the call and webcast may include predictions, estimates or other information that might be considered forward-looking.

在我們開始正式演講之前，我想提醒大家，電話會議和網路廣播中的陳述可能包括預測、估計或其他可能被視為前瞻性的資訊。

While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this presentation.

雖然這些前瞻性陳述代表了我們目前對未來的判斷，但它們受到風險和不確定性的影響，可能導致實際結果大不相同。請注意不要過度依賴這些前瞻性陳述，這些陳述僅反映我們截至本報告發布之日的觀點。

Please keep in mind that we are not obligating ourselves to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events. Throughout today's discussion, we will attempt to present some important factors relating to our business that may affect our predictions.

請記住，我們沒有義務根據新資訊或未來事件修改或公開發布這些前瞻性陳述的任何修改結果。在今天的討論中，我們將嘗試提出一些與我們的業務有關的可能影響我們預測的重要因素。

You should also review our most recent Form 10-K and Form 10-Q for a more complete discussion of these factors and other risks, particularly under the heading Risk Factors. A press release detailing these results crossed the wire this afternoon and is available in the Investor Relations section of our company's website, heartbeam.com.

您還應該查看我們最新的 10-K 表格和 10-Q 表格，以更全面地討論這些因素和其他風險，特別是在「風險因素」標題下。詳細介紹這些結果的新聞稿已於今天下午發布，可在我們公司網站 heartbeam.com 的投資者關係部分查閱。

Your host today, Rob Eno, Chief Executive Officer; Branislav Vajdic, President and Founder; Tim Cruickshank, Chief Financial Officer, will present results of operations for the third quarter ended September 30, 2024. At this time, I will turn the call over to HeartBeam Chief Executive Officer, Mr. Rob Eno.

今天的主持人是執行長 Rob Eno； Branislav Vajdic，總裁兼創辦人；財務長 Tim Cruickshank 將公佈截至 2024 年 9 月 30 日第三季的營運業績。現在，我將把電話轉給 HeartBeam 執行長 Rob Eno 先生。

Thank you, operator. The topics we'll cover on today's call are listed on the slide. I'll provide a brief overview of the company's vision and then quickly get into providing an update on the status of our FDA submission, which is top of mind for everyone. We'll then walk you through our management and company updates, financial results, and upcoming milestones before turning it over to Q&A.

謝謝您，接線生。幻燈片上列出了我們在今天的電話會議上將討論的主題。我將簡要介紹公司的願景，然後快速介紹我們向 FDA 提交的文件的最新情況，這是每個人最關心的問題。然後，我們將向您介紹我們的管理和公司最新動態、財務表現以及即將到來的里程碑，然後再進入問答環節。

HeartBeam has developed core technology that enables a new paradigm in cardiac care. HeartBeam's developed the first ever cable-free 12-lead ECG that patients can use wherever they are. We do this by using a vector-based approach, capturing the heart's electrical signals from three dimensions, and then synthesizing a 12-lead ECG. This allows users to capture the highest resolution data possible in a patient carried device, far greater than with existing wearables.

HeartBeam 開發了核心技術，為心臟護理開創了新模式。HeartBeam 開發出了首個無線 12 導程心電圖儀，患者無論身在何處都可以使用。我們採用基於向量的方法，從三維空間捕捉心臟的電訊號，然後合成 12 導程心電圖。這使得用戶能夠在患者攜帶的裝置中捕獲最高解析度的數據，遠高於現有的可穿戴設備。

On top of this, applying AI algorithms to this high-resolution data opens up a world of possibilities, driving personalized insights. We believe that there are multiple large markets where our technology is applicable. And together, these addressable markets are worth more than $100 billion per year in the US alone.

除此之外，將人工智慧演算法應用於這些高解析度數據將開啟一個無限可能的世界，帶來個人化的洞察。我們相信，我們的技術可適用於多個大型市場。光是在美國，這些潛在市場每年的價值就超過 1000 億美元。

HeartBeam is well positioned to disrupt these markets with a strategy that starts with symptom-driven diagnosis moves to monitoring and screening and ultimately to replacing traditional 12-lead ECGs in hospitals and beyond as a new standard of care. In an upcoming slide, we'll provide you with an update on our FDA submission. We believe this clearance is a foundational clearance for our technology and opens multiple product paths.

HeartBeam 憑藉其策略佔據了顛覆這些市場的有利位置，該策略首先從症狀驅動的診斷轉向監測和篩檢，最終取代醫院及其他地方的傳統 12 導聯心電圖，成為新的護理標準。在即將發布的幻燈片中，我們將為您提供有關 FDA 提交的最新資訊。我們相信，此項批准是我們技術的基礎性批准，並開啟了多種產品路徑。

Over the past few months, we've put significant effort into further refining our go-to-market strategy. Our initial plan is focused on direct patient pay, targeting concierge and preventive cardiology practices. Beyond this, we'll gather evidence of the clinical and cost effectiveness benefits of our system in specific use cases, which we believe will be the basis for payment by insurers, hospitals, and integrated delivery networks.

在過去的幾個月裡，我們付出了巨大的努力來進一步完善我們的市場策略。我們最初的計劃專注於患者直接付費，針對禮賓和預防心臟病學實踐。除此之外，我們還將在特定用例中收集我們的系統臨床和成本效益優勢的證據，我們相信這將成為保險公司、醫院和綜合交付網路付款的基礎。

There are three fundamental advances which form the core of our IP and enable our approach. First, we use a vector-based approach. Vector cardiography has been an alternative to 12-lead ECG for decades. It captures the heart's electrical signals from three axis, X, Y and Z. Ambulatory ECG devices that are available today do not use this vector approach.

有三項根本性的進步構成了我們的 IP 的核心並使我們的方法得以實現。首先，我們使用基於向量的方法。幾十年來，向量心動圖一直是 12 導程心電圖的替代品。它從 X、Y 和 Z 三個軸捕獲心臟的電訊號。

Next, we're able to capture the three dimensions through a novel and protected way. Two chest electrodes capture the vertical axis, two finger electrodes capture the horizontal dimension and the key invention is a novel resistive network that captures the Z-axis into the body.

接下來，我們能夠透過一種新穎且受保護的方式捕捉三維空間。兩個胸部電極捕捉垂直軸，兩個手指電極捕捉水平維度，而關鍵發明是一種將 Z 軸捕捉到體內的新型電阻網絡。

And finally, we take the 3D vector signals and synthesize the 12-lead ECG. There are established ways to make this conversion, but they're population-based. In order to create an even more accurate 12-lead ECG, we use a personalized transformation matrix.

最後，我們採用 3D 向量訊號並合成 12 導程心電圖。目前已經有了實現這種轉變的既定方法，但是這些方法都是以人口為基礎的。為了創建更精確的 12 導程心電圖，我們使用了個人化的轉換矩陣。

When the patient is onboarded, we take a single 12-lead ECG and combine this with a HeartBeam reading. This creates the patient's personalized transformation matrix, which is saved and used going forward. These three fundamental advances enable the breakthrough application, and we have a total of 17 issued patents worldwide.

當患者入院時，我們會進行單次 12 導程心電圖檢查並將其與 HeartBeam 讀數結合。這會創建患者的個人化轉變矩陣，該矩陣會被儲存並繼續使用。這三項基礎進步促成了這項突破性應用，我們在全球共擁有 17 項已頒發的專利。

Now let's get into our update on our FDA submission. Our 510(k) submission continues to progress through active review by the FDA. Since our last update, we've responded to the questions asked by the FDA and are working through clarifications. We continue to be confident in the FDA clearance. The FDA is engaged and fully responsive, and we continue to work interactively with them. While we can't predict time lines or results related to FDA submissions, we remain optimistic that we will achieve our foundational FDA clearance, and we will update the market as soon as it's achieved.

現在讓我們來了解一下我們向 FDA 提交的最新情況。我們的 510(k) 提交正在透過 FDA 的積極審查繼續取得進展。自上次更新以來，我們已經回覆了 FDA 提出的問題並正在努力澄清。我們仍然對 FDA 的批准充滿信心。FDA 積極參與並積極回應，我們將繼續與他們保持互動合作。雖然我們無法預測與 FDA 提交相關的時間表或結果，但我們仍然樂觀地認為我們將獲得基礎 FDA 批准，並且我們將在獲得批准後立即向市場更新。

Over the past quarter, we've evolved our management team as we prepare for commercialization. I'm honoured to leave the organization at such a pivotal time. My career over the past 30 years has focused on creating go-to-market strategies for multiple breakthrough products. The HeartBeam technology is truly transformative and will have a huge impact on how cardiac care is managed. I look forward to leveraging my commercial expertise to ensure the company is set up for success.

在過去的一個季度中，我們為商業化的準備而改善了管理團隊。我很榮幸能在如此關鍵的時刻離開該組織。過去 30 年，我的職業生涯一直致力於為多種突破性產品製定市場進入策略。HeartBeam 技術具有真正的變革性，並將對心臟護理管理方式產生巨大影響。我期待利用我的商業專業知識來確保公司的成功。

I'm also thrilled to partner with Tim Cruickshank as our new CFO. He brings an incredible wealth of knowledge to growing businesses with disruptive technologies, and I know we'll benefit from that. Additionally, I look forward to working with Lance Myers, who will leverage his prior experience from Google to guide the company and how we apply AI to our core technology.

我也很高興與 Tim Cruickshank 合作擔任我們的新任財務長。他為利用顛覆性技術成長的企業帶來了豐富的知識，我知道我們將從中受益。此外，我期待與 Lance Myers 合作，他將利用自己在谷歌的經驗來指導公司以及如何將 AI 應用於我們的核心技術。

Of course, none of this would have been possible without our founder, Branislav Vajdic. His vision and drive to change how cardiac care is managed is what got the company to this point, and I look forward to my continued partnership with Branislav, who will play an integral role in our success going forward.

當然，如果沒有我們的創辦人 Branislav Vajdic，這一切都不可能實現。他的遠見和改變心臟護理管理方式的動力使公司走到了今天這一步，我期待著與 Branislav 繼續合作，他將在我們未來的成功中發揮不可或缺的作用。

Now I'd like to pass it over to Branislav, who wants to add a few words.

現在我想把發言權交給布拉尼斯拉夫，他想補充幾句。

Thanks, Rob. Since we started working together, Rob and I have always had a great synergy, and I knew he would be the right leader for HeartBeam when we reach the point of commercialization. This transition is part of a long-planned evolution for the company, and Rob is the right person to lead the company with his keen understanding of sales, strategic marketing and go-to-market strategies.

謝謝，羅布。自從我們開始合作以來，Rob 和我一直有著很好的協同作用，我知道當我們達到商業化階段時，他將是 HeartBeam 的合適領導者。此次轉型是公司長期規劃變革的一部分，Rob 對銷售、策略行銷和市場進入策略有著敏銳的理解，是領導公司的合適人選。

I'm thrilled to be able to continue working with him in a new capacity as I turn my focus on innovating on our vector-based technology, driving research and development efforts and working with Lance on advancing our artificial intelligence applications.

我很高興能夠以新的身分繼續與他合作，我將把我的重點轉向創新基於向量的技術，推動研發工作，並與 Lance 合作推進我們的人工智慧應用。

Please join me in congratulating Rob in his new role as CEO. I want to thank all of you for the support you have given me as CEO and ask that you give the same support to Rob moving forward as he drives the growth of the company. Rob?

請和我一起祝賀 Rob 出任執行長新職務。我要感謝大家對我擔任執行長的支持，並請大家在羅布推動公司發展的過程中給予他同樣的支持。搶？

Thanks so much, Branislav. Let's now turn our attention to some key updates. We have a significant and growing body of clinical evidence on HeartBeam's technology. We have nine peer-reviewed publications and presentations on studies that have collectively enrolled more than 500 patients, demonstrating the technology's potential in advancing cardiac care. These include the fundamentals of the technology as well as studies on the use of the technology in both arrhythmia and ischemia.

非常感謝，Branislav。現在讓我們專注於一些關鍵的更新。我們擁有大量且不斷成長的有關 HeartBeam 技術的臨床證據。我們有九份經過同行評審的出版物和研究報告，共招募了 500 多名患者，展示了該技術在推動心臟護理方面的潛力。這些包括該技術的基礎以及該技術在心律不整和缺血方面的應用研究。

For both those clinical areas, we've studied the similarity of our signals to simultaneously recorded 12-lead ECGs. At the American Heart Association Conference later this month, results will be presented from a pilot study comparing our synthesized 12-lead ECG to a standard 12-lead ECG for the detection of arrhythmias.

對於這兩個臨床領域，我們都研究了我們的訊號與同時記錄的 12 導程心電圖的相似性。在本月稍後舉行的美國心臟協會會議上，我們將展示一項試驗研究的結果，該研究將我們合成的 12 導聯心電圖與標準 12 導聯心電圖在心律不整檢測方面的比較。

The pilot study is a precursor to our pivotal US study, which will be submitted as part of our package for FDA clearance for the 12-lead ECG synthesis. In addition, two studies were presented earlier this year on our AI algorithm in the classification of arrhythmias.

這項試點研究是我們在美國進行的關鍵研究的前身，該研究將作為我們向 FDA 提交的 12 導程心電圖合成審批方案的一部分。此外，今年早些時候，我們還發表了兩項有關我們的心律不整分類人工智慧演算法的研究。

For ischemia, our study on coronary occlusions was published last year in JACC Advances. And at this month's AHA, data will be presented on a novel algorithm used in conjunction with our ECG technology in detecting heart attacks. Beyond these clinical studies, we have more than 13,000 recordings for more than 250 people, providing meaningful insights as we learn about the performance and usability of the system.

對於缺血，我們關於冠狀動脈阻塞的研究去年發表在《JACC Advances》上。在本月的 AHA 會議上，我們將展示一種與我們的 ECG 技術結合使用來檢測心臟病的新演算法的數據。除了這些臨床研究之外，我們還為 250 多人收集了超過 13,000 筆記錄，為我們了解系統的效能和可用性提供了有意義的見解。

In addition to our significant body of clinical data, we continue to receive validation from our peers. During the renowned Global Healthcare Conference in October, HeartBeam was chosen from thousands of companies and named Rising Star at the Sixth Annual Digital Health Hub Foundation Awards in the Home Health Diagnostic category. This comes months after we received a MedTech Breakthrough Award for best new ECG technology solution.

除了我們大量的臨床數據外，我們還持續獲得同行的認可。在十月份著名的全球醫療保健大會上，HeartBeam 從數千家公司中脫穎而出，榮獲第六屆年度數位健康中心基金會獎家庭健康診斷類「新星」稱號。幾個月前，我們剛獲得最佳新型心電圖技術解決方案醫療技術突破獎。

One of the main challenges in cardiac care is helping patients get the care they need in a timelier manner to prevent worse outcomes or an increased risk of death. These awards are a validation of our dedicated team's hard work to deliver a simple way for patients to capture high fidelity ECG signals wherever they are when symptoms occur to minimize any delays in care.

心臟護理的主要挑戰之一是幫助患者及時獲得所需的護理，以防止更糟糕的後果或增加死亡風險。這些獎項是對我們專業團隊辛勤工作的認可，他們為患者提供了一種簡單的方法，使他們能夠在症狀出現時無論身在何處都能捕捉高保真心電圖信號，從而最大限度地減少護理延誤。

And with that, I'll turn it over to Tim to take us through the financials for the quarter.

接下來，我將把時間交給蒂姆 (Tim) 來向我們介紹本季的財務狀況。

Thanks, Rob. The company remains focused on financial discipline and delivering on milestones, while minimizing cash burn. I began with HeartBeam in September and in my short time here, I've been really impressed with not only the quality of the team, but also in the team's resourcefulness in maximizing resources across functions.

謝謝，羅布。該公司將繼續注重財務紀律和實現里程碑，同時盡量減少現金消耗。我於去年九月開始加入 HeartBeam，在這裡的短暫時間裡，我不僅對團隊的素質印象深刻，而且對團隊在跨職能部門最大化利用資源的足智多謀也印象深刻。

Net loss for the third quarter ending 30 September 2024 was just under $5 million, $4.979 million. When adjusted for noncash items such as share-based compensation and timing differences, the net cash used in operating activities was just $3.3 million, which is more heavily weighted to our R&D and clinical initiatives than the G&A. The cash balance at 30 September 2024 was $5.8 million.

截至 2024 年 9 月 30 日的第三季淨虧損略低於 500 萬美元，為 497.9 萬美元。經股權激勵和時間差異等非現金項目調整後，經營活動所用淨現金僅為 330 萬美元，其中，我們的研發和臨床計劃所佔比重大於一般及行政費用。截至 2024 年 9 月 30 日的現金餘額為 580 萬美元。

In coming on board with the company, the initiative I was given was twofold: utilize my past experience in leading and building strong teams to be a partner to Rob and the Board beyond the traditional CFO role and also to help provide the company with the resources and structure necessary to execute on its goals.

加入公司後，我獲得了雙重機會：利用我過去領導和建立強大團隊的經驗，成為 Rob 和董事會的合作夥伴，超越傳統的財務長角色，並幫助公司提供實現其目標所需的資源和結構。

So I've spent the last month working with the team to further refine our strategy as well as engaging with all the key stakeholders from investors to employees. And I'm happy to say we have strong support from existing shareholders that are committed to groundbreaking technology like HeartBeam's.

因此，我花了一個月的時間與團隊合作，進一步完善我們的策略，並與從投資者到員工的所有關鍵利害關係人接觸。我很高興地說，我們得到了現有股東的大力支持，他們致力於 HeartBeam 等突破性的技術。

Here at HeartBeam, we're focused on maintaining and adding value-add investors and we'll finance the company opportunistically to manage dilution. With our upcoming milestones, which Rob is going to walk you through on the next slide, we're confident we have all the pieces in place to strategically capitalize the business, and we'll continue to align our cash burn to the achievement of our key milestones in advance of commercialization. Back over to you, Rob.

在 HeartBeam，我們專注於維護和增加增值投資者，並將適時為公司提供融資以控制稀釋。隨著我們即將到來的里程碑，Rob 將在下一張投影片中向您介紹，我們相信我們已經準備好一切來策略性地利用業務，並且我們將繼續調整我們的現金消耗以達到商業化之前的關鍵里程碑。回到你這裡，羅布。

Thanks, Tim. We have a number of important value creation milestones, which we anticipate achieving in the coming months. First is our foundational FDA clearance. As we've mentioned, we continue to have productive discussions with FDA, have responded to the latest set of questions and are working through clarifications, and we continue to be confident about receiving that clearance. As we discussed previously, this foundational clearance is a major milestone for the company as it's the basis of all future submissions.

謝謝，蒂姆。我們有許多重要的價值創造里程碑，預計在未來幾個月內實現。首先是我們的基礎FDA批准。正如我們所提到的，我們繼續與 FDA 進行富有成效的討論，回答了最新的一系列問題並正在努力澄清，我們仍然對獲得該批准充滿信心。正如我們之前所討論的，這項基礎許可對公司來說是一個重要的里程碑，因為它是所有未來提交的基礎。

Our second planned FDA 510(k) submission is for the algorithms that synthesize a 12-lead ECG from our 360-degree vector signals. The basis of this submission is our VALID-ECG study, a 198-patient study conducted at five US centers.

我們計劃向 F​​DA 510(k) 提交的第二份文件是針對從我們的 360 度向量訊號合成 12 導聯心電圖的演算法。本次提交的基礎是我們的VALID-ECG研究，這是一項在美國五個中心進行的198名患者的研究。

The VALID-ECG study evaluated HeartBeam synthesized 12-lead ECG alongside simultaneously recorded standard 12-lead ECGs for arrhythmia detection. We've completed enrolment in VALID-ECG, and we'll be submitting those results to the FDA as part of our planned second submission. We held two pre-submission meetings with FDA to discuss the study and the endpoints.

VALID-ECG 研究評估了 HeartBeam 合成的 12 導程心電圖以及同時記錄的標準 12 導程心電圖在心律不整檢測方面的表現。我們已經完成了 VALID-ECG 的註冊，我們將把這些結果作為計劃中的第二次提交的一部分提交給 FDA。我們與 FDA 舉行了兩次提交前會議，討論研究和終點。

As mentioned earlier, results of an 80-patient pilot study measuring the same endpoints will be presented at the AHA this month. We're anticipating submitting the second 510(k) application soon after we receive the initial FDA clearance.

如前所述，一項針對 80 名患者的、測量相同終點的試驗研究的結果將於本月在 AHA 上公佈。我們預計在收到初步 FDA 批准後不久提交第二份 510（k）申請。

We can't predict the timing of the second clearance, but we're estimating it will occur next year. Upon the initial 510(k) clearance, we're prepared to start an early access program to provide us with important feedback on the use of the system by patients, prescribing physicians, and a cardiologist reader service. Upon the 510(k) clearance for the 12-lead synthesis software, we expect to begin a limited commercial launch.

我們無法預測第二次清理的時間，但我們估計它將在明年發生。在獲得初始 510(k) 批准後，我們準備啟動早期訪問計劃，以便為我們提供有關患者、開處方醫生和心臟病專家閱讀器服務使用該系統的重要反饋。在 12 導聯合成軟體獲得 510(k) 許可後，我們預計將開始有限的商業發布。

Next is our AI effort, which initially will focus on the classification of arrhythmias. As mentioned previously, we've presented clinical data on the algorithm. We're planning a clinical study called RAISE-ECG to demonstrate the performance of the AI algorithm in the classification of the signal as sinus rhythm or other arrhythmias. After enrolment is complete, we plan to submit these results to the FDA.

接下來是我們的人工智慧努力，最初將專注於心律不整的分類。如前所述，我們已經提供了有關該演算法的臨床數據。我們正在計劃一項名為 RAISE-ECG 的臨床研究，以展示 AI 演算法在將訊號分類為竇性心律或其他心律不整方面的表現。註冊完成後，我們計劃將這些結果提交給 FDA。

And in the coming months, we anticipate beginning interactions with FDA on the expansion of our clinical indication from arrhythmia to ischemic events. And finally, we have the two clinical studies to be presented at AHA this month, and we expect to have several additional data releases next year.

在接下來的幾個月裡，我們預計將開始與 FDA 互動，將我們的臨床適應症從心律不整擴展到缺血事件。最後，我們將於本月在 AHA 上展示兩項臨床研究，並且預計明年將發布幾項額外數據。

So in closing, we continue to be engaged in productive discussions with the FDA and continue to be optimistic we will achieve our foundational FDA clearance. Upon the initial 510(k) clearance, we're prepared to start an early access program to provide us with important feedback on the use of the system by patients, prescribing physicians, and a cardiologist reader service.

最後，我們將繼續與 FDA 進行富有成效的討論，並繼續樂觀地認為我們將獲得基礎 FDA 的批准。在獲得初始 510(k) 批准後，我們準備啟動早期訪問計劃，以便為我們提供有關患者、開處方醫生和心臟病專家閱讀器服務使用該系統的重要反饋。

Over the last quarter, we've updated the management team to better position ourselves for the upcoming commercialization. In addition, adding Lance Myers as our Chief AI Officer and bringing Branislav's incredible capabilities to lead our technical effort will position us extremely well to continue leading in this fast-moving field.

上個季度，我們更新了管理團隊，以便為即將到來的商業化做好更好的準備。此外，聘請 Lance Myers 擔任我們的首席人工智慧官，並讓 Branislav 的非凡能力來領導我們的技術工作，將使我們處於非常有利的地位，繼續在這個快速發展的領域保持領先地位。

The body of clinical evidence supporting our technology continues to grow, and we're excited to have a presence at the upcoming American Heart Association Scientific Conference next week where data on two studies on HeartBeam's technology will be presented.

支持我們技術的臨床證據不斷增加，我們很高興能夠參加下週即將召開的美國心臟協會科學會議，將展示有關 HeartBeam 技術的兩項研究的數據。

While we're preparing for commercialization and strengthening our evidence base, we have a clear focus on delivering value. We have line of sight to the upcoming clinical and regulatory milestones that will help put the company a position for commercial launch in 2025. The company remains focused on financial discipline and minimizing cash burn while delivering on milestones. I look forward to providing our shareholders with further updates in the near term.

在我們為商業化做準備並加強證據基礎的同時，我們明確地專注於實現價值。我們關注即將到來的臨床和監管里程碑，這將有助於該公司在 2025 年商業化上市。該公司在實現里程碑的同時，依然注重財務紀律並盡量減少現金消耗。我期待近期向我們的股東提供進一步的最新消息。

We thank you all for attending. I'd now like to open it up to Q&A. Operator?

我們感謝大家的參加。現在我想開始問答環節。操作員？

(Operator Instructions) It looks like we have no phone questions at this time. We will now take questions from the web.

（操作員指示）看起來我們目前沒有電話問題。我們現在將回答來自網路的問題。

Our first webcast question asks, can you provide more detail on the timing of the FDA clearance? And what are the outstanding items?

我們的第一個網路廣播問題是，您能否提供有關 FDA 批准時間的更多細節？還有哪些未完成的項目？

Yes, I'll take that one. It's a great question. We've provided all the information we can at present. It's just not appropriate to discuss the details of ongoing FDA discussions. But I just want to reiterate that FDA is engaged and responsive, and we're remaining very confident in our ability to achieve the FDA clearance in the near term.

是的，我要那個。這是一個很好的問題。目前我們已經提供了我們所能提供的所有資訊。討論 FDA 正在進行的討論的細節是不合適的。但我只想重申， FDA 正在積極參與並積極回應，我們對在短期內獲得 FDA 批准的能力仍然非常有信心。

And then beyond that, as we've discussed, in preparation for the commercialization, we've evolved the management team, and we're currently preparing for this early access program, which will begin after the initial FDA clearance.

除此之外，正如我們所討論的，為了準備商業化，我們已經組建了管理團隊，我們目前正在為這個早期訪問計劃做準備，該計劃將在獲得 FDA 初步批准後開始。

Our next webcast question asks, given your cash burn, what are your plans for raising capital?

我們的下一個網路廣播問題是，考慮到您的現金消耗，您有何籌集資金的計劃？

Tim, do you want to take that one?

提姆，你想拿那個嗎？

Rob, thanks. Yes, important question. We're managing our cash burn really closely. And with this quarter's operating cash flow at just $3.3 million, I believe, doing an effective job headcount just around 20. So keeping a lot of cost variable related to clinical and R&D milestones. And Rob walked you through the milestone slide where we've got really good line of sight to what we're going to be achieving over the next coming quarters.

羅布，謝謝。是的，重要的問題。我們正在嚴格控制現金消耗。本季的營運現金流僅 330 萬美元，我認為，有效工作員工人數僅約 20 人。因此，與臨床和研發里程碑相關的成本變數很多。Rob 向您介紹了里程碑幻燈片，我們對接下來幾季要實現的目標有了很好的認識。

As we stated on the call, we've got strong support from existing shareholders committed to this groundbreaking technology. And our focus is on maintaining and adding value at investors, which we believe will allow us to finance the company opportunistically, while managing dilution here in the short term. So with our upcoming milestones, we're really confident we've got the pieces in place to capitalize the business in a strategic manner in alignment with cash requirements in advance of commercialization.

正如我們在電話會議上所說，我們得到了現有股東對這項突破性技術的大力支持。我們的重點是維護和增加投資者的價值，我們相信這將使我們能夠抓住機會為公司融資，同時在短期內管理股權稀釋。因此，隨著我們即將到來的里程碑，我們非常有信心我們已經準備好以策略性方式利用業務，以滿足商業化之前的現金需求。

Our next webcast question asks, congratulations to Rob on his appointment to CEO, and thank you to Branislav for providing a strong succession plan. That said, can you provide more context on the timing and the reason for the change in CEO from Branislav to Rob?

我們的下一個網路廣播問題是，恭喜 Rob 被任命為首席執行官，並感謝 Branislav 提供強有力的繼任計劃。話雖如此，您能否提供更多有關執行長從 Branislav 更換為 Rob 的時間和原因的背景資訊？

Sure. I'll take that one. First, thank you for that. As we mentioned, the transition has been planned for a long time. Branislav and I have worked very closely together since I joined the company, which was January of 2023 and even before then, when I served as a consultant.

當然。我要那個。首先，對此表示感謝。正如我們所提到的，這一轉變已經籌劃了很長時間。自從我 2023 年 1 月加入公司以來，甚至在那之前，當我擔任顧問時，Branislav 和我一直密切合作。

Branislav is -- I think he's a true visionary, but also a hands-on leader and really took the company from founding to where we are now, where we have strong clinical data, the strong pipeline of products, and we believe we're close to the first FDA clearance. So by being at the commercial stage now, Branislav long thought this is the right time for a transition and having this company led by someone with more of a commercial background.

我認為 Branislav 是一位真正的夢想家，也是一位實踐型的領導者，他帶領公司從創立之初就取得了現在的成就，我們擁有強大的臨床數據和強大的產品線，而且我們相信我們已接近獲得 FDA 的首次批准。因此，由於目前公司已處於商業階段，因此 Branislav 一直認為這是轉型的最佳時機，應該讓一位擁有更多商業背景的人來領導公司。

I've been fortunate to have worked with a number of groundbreaking technologies from one of the first drug-eluting stents to pioneering lasers for cataract surgery to FFR-CT that noninvasively measures blood flow. And I think what I learned from those developing and executing those go-to-market strategies really has prepared me well for the stage that HeartBeam is at in our upcoming introduction into the market.

我很幸運能夠接觸到許多突破性的技術，從最早的藥物洗脫支架到用於白內障手術的先鋒雷射器，再到非侵入性測量血流的 FFR-CT。我認為，我從制定和執行這些市場進入策略的人身上學到的東西確實讓我為 HeartBeam 即將進入市場的階段做好了充分的準備。

So I just -- I guess I want to finish by just emphasizing that Branislav is going to stay deeply involved with the company. He's going to lead all of the technical efforts. So advanced R&D, our development projects, and the AI efforts. So the company is going to continue to benefit from his skills and his energy as we go forward. Branislav and I have had a close partnership, and that's definitely going to continue going forward.

所以我只是——我想我最後想強調的是，布拉尼斯拉夫將繼續深入參與公司事務。他將領導所有技術工作。因此，我們擁有先進的研發、開發專案和人工智慧努力。因此，隨著我們未來的發展，公司將繼續受益於他的技能和精力。布拉尼斯拉夫和我保持著密切的合作關係，而且這種合作關係肯定會繼續下去。

Our next question asks, can you provide an update on how the timing and results of the VALID-ECG study?

我們的下一個問題是，您能否提供 VALID-ECG 研究的時間和結果的最新情況？

Sure. Happy to take that one as well. So the VALID-ECG study, just as a quick reminder, this is the 198-patient study at five US centers, and it had simultaneously recorded HeartBeam signals and standard 12-lead ECGs. And we -- as we mentioned before, we've completed enrolment.

當然。我也很高興接受這個。因此，VALID-ECG 研究，只是快速提醒一下，這是在美國五個中心對 198 名患者進行的研究，它同時記錄了 HeartBeam 訊號和標準 12 導程心電圖。正如我們之前提到的，我們已經完成招生。

We have analysed the data, and it will be the basis of this upcoming second FDA submission on the 12-lead synthesis. Unfortunately, we can't talk about the results because the data have not yet been peer-reviewed, and it is the basis of that submission.

我們已經分析了數據，它將成為即將向 FDA 提交的 12 個先導合成的第二次申請的基礎。不幸的是，我們無法談論結果，因為數據尚未經過同行評審，而且它是提交的基礎。

But I did want to draw everyone's attention to the upcoming data at the American Heart Association. It's going to be in about 10 days. That presentation is on the results of the 80-patient pilot study that measures the same endpoints as VALID-ECG.

但我確實想讓大家關注美國心臟協會即將公佈的數據。大約需要 10 天。該演示是關於 80 名患者的試點研究的結果，該研究測量與 VALID-ECG 相同的終點。

And our last webcast question asks, if everything goes right with the FDA, what could 2025 revenues look like for HeartBeam?

我們最後一個網路直播的問題是，如果 FDA 一切順利，HeartBeam 到 2025 年的收入會是多少？

Yes, Tim, why don't you take that one?

是的，提姆，你為什麼不拿那個？

Sure. I mean the opportunity in front of us is massive. This is such an exciting opportunity. And this is a question I can't wait to answer in more detail in future quarters. I'd say, for now, I think the company stated in previous quarters, we don't anticipate significant revenue in 2025. But of course, we're going to be working to bring forward time lines and expectations wherever possible and of course, updating the market on our progress throughout 2025. You saw the slide where we give a real solid road map of the milestones that we're laser-focused on.

當然。我的意思是我們面前的機會是巨大的。這是一個令人興奮的機會。我迫不及待地想在未來幾季更詳細地回答這個問題。我想說，就目前而言，我認為公司在前幾個季度表示，我們預計 2025 年不會有可觀的收入。但當然，我們將盡可能地提前時間表和期望，當然，我們將向市場通報我們在 2025 年取得的進展。您在幻燈片中看到了我們給出的真正堅實的路線圖，列出了我們重點關注的里程碑。

And on the back of our upcoming FDA clearance, I think it's critical we take the time now to market the HeartBeam system through this early access program. That's kind of our initial beta, if you will, commercial launch. So getting the critical user feedback for our go-to-market strategy, refining our pricing models, we're going to be gaining all of that information, that critical information in the coming quarters. And that will give us the biggest impact on our commercial launch when it comes.

在我們即將獲得 FDA 批准的情況下，我認為我們現在應該花時間透過這個早期使用計劃來推銷 HeartBeam 系統，這一點至關重要。如果你願意的話，這就是我們的初始測試版，商業發布版。因此，為了獲得我們進入市場策略的關鍵用戶回饋，改進我們的定價模型，我們將在未來幾個季度內獲得所有這些信息，這些關鍵資訊。這將對我們的商業發布產生最大的影響。

That concludes our webcast questions.

我們的網路直播提問到此結束。

I would now like to turn the call back over to Mr. Rob Eno for his closing remarks.

現在我想將發言權交還給羅布·伊諾先生，請他作最後發言。

Thank you, operator. I'd like to thank each of you for joining our earnings conference call today. It's going to be an exciting few months ahead for the company as we look to achieve a number of critical milestones in the very near term.

謝謝您，接線生。我想感謝你們每個人今天參加我們的收益電話會議。對於公司來說，接下來的幾個月將是令人興奮的幾個月，因為我們希望在短期內實現許多關鍵的里程碑。

We look forward to continuing to update you on our ongoing progress and growth as we close out the 2024 year. If we were unable to answer any of your questions today, please reach out to our IR firm, MZ Group, who would be more than happy to assist.

我們期待在 2024 年即將結束時繼續向您通報我們的持續進展和成長。如果我們今天無法回答您的任何問題，請聯絡我們的 IR 公司 MZ Group，他們會非常樂意為您提供協助。

Ladies and gentlemen, this concludes today's conference call and webcast. Thank you for your participation. You may now disconnect.

女士們、先生們，今天的電話會議和網路廣播到此結束。感謝您的參與。您現在可以斷開連線。