Lucid Diagnostics Inc (LUCD) 2023 Q2 法說會逐字稿

Good day, and welcome to the Lucid Diagnostics Second Quarter 2023 Business Update Conference Call. (Operator Instructions) Please note, this event is being recorded.

美好的一天，歡迎參加 Lucid Diagnostics 2023 年第二季度業務更新電話會議。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Michael Parks, VP, Investor Relations. Please go ahead.

我現在想將會議交給投資者關係副總裁邁克爾·帕克斯 (Michael Parks)。請繼續。

Thank you, Betsy. Good morning, everyone. Thank you for participating in today's second quarter 2023 business update call.

謝謝你，貝特西。大家，早安。感謝您參加今天的 2023 年第二季度業務更新電話會議。

The press release announcing our business update for the company and financial results for the 3 and 6 months ended June 30, 2023, is available on the Lucid website.

宣佈公司業務更新以及截至 2023 年 6 月 30 日的 3 個月和 6 個月財務業績的新聞稿可在 Lucid 網站上獲取。

Please take a moment to read the disclaimer about forward-looking statements in the press release. The business update, press release and this conference call include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from statements made. Factors that could cause actual results to differ are described in the disclaimer in our filings with the U.S. Securities and Exchange Commission.

請花一點時間閱讀新聞稿中有關前瞻性陳述的免責聲明。業務更新、新聞稿和本次電話會議包含前瞻性聲明，這些前瞻性聲明受到已知和未知的風險和不確定性的影響，可能導致實際結果與聲明存在重大差異。我們向美國證券交易委員會提交的文件中的免責聲明中描述了可能導致實際結果不同的因素。

For a list and description of these and other important risks and uncertainties that may affect future operations, see Part I, Item 1A, entitled Risk Factors, and Lucid's most recent annual report on Form 10-Q filed with the SEC, and subsequent updates filed in quarterly reports on Form 10-Q and any subsequent Form 8-K filings. Except as required by law, Lucid disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions or circumstances on which the expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

有關這些以及可能影響未來運營的其他重要風險和不確定性的列表和描述，請參閱第一部分第1A 項，標題為“風險因素”，以及Lucid 向SEC 提交的10-Q 表格中的最新年度報告以及隨後提交的更新在表格 10-Q 和任何後續表格 8-K 申報的季度報告中。除法律要求外，Lucid 不承擔任何公開更新或修改任何前瞻性陳述的意圖或義務，以反映預期的變化或預期所依據的事件、條件或情況的變化，或可能影響實際結果的可能性的變化。將與前瞻性陳述中包含的內容有所不同。

I would now like to turn the call over to Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics. Dr. Aklog?

我現在想把電話轉給 Lucid Diagnostics 董事長兼首席執行官 Lishan Aklog 博士。阿克洛格博士？

Thank you, Mike, and thank you, everyone, for joining us this morning. I appreciate you taking the time. We look forward to providing you an update of the last quarter. As we mentioned in the press release yesterday, we really closed out very strongly for the first half of this year. So let's just start with some of the second quarter highlights.

謝謝邁克，也謝謝大家今天早上加入我們。我很感謝您抽出時間。我們期待為您提供上季度的最新情況。正如我們在昨天的新聞稿中提到的，我們今年上半年的業績確實非常強勁。讓我們從第二季度的一些亮點開始吧。

From a commercial execution side, we're excited to have grown test volume to just over 2,200 EsoGuard tests. That's 20% quarter-on-quarter. So another double-digit quarterly growth and 159% on an annual basis. We'll talk in a little bit more detail later about the various aspects of our commercial execution, but the drivers of this growth were increased seller productivity and continuing increased activities through our satellite test centers and our high-volume testing events.

從商業執行方面來看，我們很高興將測試量增加到 2,200 多個 EsoGuard 測試。環比增長 20%。因此，季度增長率再次達到兩位數，年度增長率達到 159%。稍後我們將更詳細地討論我們商業執行的各個方面，但這種增長的驅動因素是賣家生產力的提高以及通過我們的衛星測試中心和大容量測試活動持續增加的活動。

We also had some very important strategic accomplishments in the last quarter and in recent weeks that really bode well for us in the coming quarters. A very important milestone was that we upgraded our revenue cycle management infrastructure and provider. That was a process that took all of May and most of June, and that process is now completed. Again, I'll talk about that in some more detail. And we saw an immediate positive impact on our claims processing and payments, which Dennis and I will both review in some detail during the month of July.

我們在上個季度和最近幾週還取得了一些非常重要的戰略成就，這對我們未來幾個季度來說確實是個好兆頭。一個非常重要的里程碑是我們升級了收入周期管理基礎設施和提供商。這個過程花了整個五月和六月的大部分時間，現在這個過程已經完成。我將再次更詳細地討論這一點。我們看到了對我們的索賠處理和付款的直接積極影響，丹尼斯和我將在 7 月份詳細審查這些影響。

The prospective clinical utility studies that we've been talking about each quarter and are very critical for our engagement with payers reached its first enrollment milestone and actually surpassed it at over 500 patients between the two studies. And those results will be -- are being analyzed. They'll be posted and the first manuscript will be submitted later this month.

我們每個季度都在談論的前瞻性臨床效用研究對於我們與付款人的接觸非常重要，達到了第一個入組里程碑，並且實際上在兩項研究之間超過了 500 名患者。這些結果將被分析。它們將被發布，第一份手稿將在本月晚些時候提交。

We also were excited to see the unprecedented results from the NCI-funded EsoGuard study for the BETRNet consortium. I'll highlight some of these results a little bit later, but the headline of 100% detection of cancer and over 80% of pre-cancer, again, we're unprecedented.

我們還很高興看到 NCI 資助的 BETRNet 聯盟 EsoGuard 研究取得了前所未有的結果。稍後我將重點介紹其中的一些結果，但 100% 檢測出癌症和超過 80% 的癌前病變的標題，我們再次表示，這是前所未有的。

And we just recently completed and executed our first direct employer contract, where, for the first time, a company will be offering EsoGuard as an employee benefit. So again, we'll talk about those in a bit more detail.

我們最近剛剛完成並執行了第一份直接雇主合同，其中，公司將首次提供 EsoGuard 作為員工福利。那麼，我們將再次更詳細地討論這些內容。

A few slides just to introduce those of you who are new to the story. Lucid has 2 key products: EsoGuard and EsoCheck. The EsoGuard molecular diagnostic test or EsoGuard esophageal DNA test and the EsoCheck cell collection device. They form the first and only commercially available test that's capable of serving as a widespread tool to prevent cancer deaths through early detection of esophageal pre-cancer. Both of the major gastroenterology associations have supported non-endoscopic biomarker testing, which ours is the only one that's commercially available as an acceptable alternative to endoscopy.

幾張幻燈片只是為了向那些剛接觸這個故事的人介紹一下。 Lucid 擁有 2 個主要產品：EsoGuard 和 EsoCheck。 EsoGuard 分子診斷測試或 EsoGuard 食管 DNA 測試和 EsoCheck 細胞收集裝置。它們是第一個也是唯一一個商業化的測試，能夠作為一種廣泛的工具，通過早期檢測食管癌前病變來預防癌症死亡。兩個主要胃腸病學協會都支持非內窺鏡生物標誌物測試，我們的測試是唯一可作為內窺鏡檢查替代品在商業上使用的測試。

Next slide. The enemy is esophageal cancer. Esophageal cancer is highly lethal and, most importantly, for our purposes, it's preventable. I won't go through all the statistics here, but they're pretty gruesome. The one that we like to highlight is the one in the middle that the mortality rate for Stage I cancer is over 40%, which is unlike any other cancer where a Stage I diagnosis is considerable -- is considered an opportunity for a cure. Therefore, the only way to actually have an impact on death is to detect the pre-cancer, and that's just not happening. Less than 5% of those recommended for screening by guidelines are undergoing endoscopy.

下一張幻燈片。敵人是食道癌。食道癌具有高度致命性，最重要的是，就我們的目的而言，它是可以預防的。我不會在這裡詳細列出所有統計數據，但它們非常可怕。我們想強調的是中間的一個，即 I 期癌症的死亡率超過 40%，這與任何其他 I 期診斷相當可觀的癌症不同，這被認為是治癒的機會。因此，真正影響死亡的唯一方法是檢測癌前病變，但這並沒有發生。根據指南建議進行篩查的人中，只有不到 5% 正在接受內窺鏡檢查。

I thought today, I'd share a patient story. Because at the end of the day, this is about patients and saving lives and are using early detection to save lives. And I did touch on this during a testimony on Capitol Hill last month, but I thought I'd really tell a bit more of the story here to give you a sense as to how every day the work that our team does is driven by the opportunity to have an impact on patients' lives, such as this patient who we'll call Steve.

我想今天我應該分享一個病人的故事。因為歸根結底，這關係到患者和拯救生命，並且正在利用早期檢測來拯救生命。上個月我在國會山作證時確實談到了這一點，但我想我真的應該在這裡多講一些故事，讓您了解我們團隊每天所做的工作是如何由機會對患者的生活產生影響，比如這位我們稱之為史蒂夫的患者。

Steve is a 70-year-old white male, former smoker, lives in the Pacific Northwest, long-time sufferer of chronic heartburn. He was on PPI medication, such as Prilosec. And he had an endoscopy over 20 years ago, but no follow-ups since then. He was in his allergist's waiting room, and he met Freddy, Freddy Foodtube, over the right. And he saw one of our educational posters of Freddy saying, "CheckYourFoodTube" The poster had some criteria on it as to who should be considered. And he (inaudible) checked through the boxes and realized he had heartburn. He was over the right age, who was a former smoker and therefore, had the risk factors.

史蒂夫是一位 70 歲的白人男性，曾經吸煙，住在太平洋西北地區，長期患有慢性胃灼熱。他正在服用 PPI 藥物，例如 Prilosec。 20多年前他接受過內窺鏡檢查，但此後就沒有再進行隨訪。他在過敏症專科醫生的候診室裡，在右邊遇到了弗雷迪（Freddy Foodtube）。他看到我們的一張 Freddy 教育海報上寫著“CheckYourFoodTube”。海報上有一些關於應該考慮誰的標準。他（聽不清）檢查了各個盒子，發現自己患有胃灼熱。他已經超過了適當的年齡，曾經是吸煙者，因此有危險因素。

He asked the physician allergist to order the test, and they did. The cell collection procedure was performed at that physician office. So this is one of those offices that where the personnel are doing EsoCheck procedure themselves. And the test came back positive.

他要求過敏症專家進行測試，他們照做了。細胞收集程序是在該醫生辦公室進行的。這是工作人員親自執行 EsoCheck 程序的辦公室之一。測試結果呈陽性。

He had a follow-up endoscopy, as all patients who have a positive EsoGuard test are recommended to undergo. And the endoscopy showed that he had a 2-inch patch, which is quite a long segment as these things go, and it showed a late-stage pre-cancer, so-called high-grade dysplasia. This is the last step before developing this highly lethal cancer, and it was picked up only because he was -- thought about his health, read the poster and was assertive about his health and asked for the test.

他接受了後續內窺鏡檢查，因為建議所有 EsoGuard 測試呈陽性的患者都接受內窺鏡檢查。內窺鏡檢查顯示他有一個 2 英寸的斑塊，就這些東西而言，這是相當長的一段，並且顯示出晚期癌前病變，即所謂的高度不典型增生。這是患上這種高度致命的癌症之前的最後一步，他之所以被確診只是因為他考慮了自己的健康狀況，閱讀了海報，對自己的健康狀況很自信，並要求進行檢查。

I think we can unequivocally say that if he had not undergone the test, at some time in the coming years, that it's very likely that his cancer -- that his dysplasia would have progressed. The pre-cancer would have progressed to cancer.

我認為我們可以明確地說，如果他沒有在未來幾年的某個時候接受檢查，他的癌症——他的發育不良很可能會進展。癌前病變可能會發展為癌症。

So he underwent what patients with this diagnosis are recommended to undergo, which is -- he was referred out of state and underwent a series of curative ablation procedures that are done using endoscopy, and that was completed last month. And I think really, I can't say any better than he had, in a direct quote, he said, "I think I saved my own life by seeing the flyer and getting a test. I'm damn lucky that I caught it when I caught it. The more prevention, the easier the cure. So that really says it all."

因此，他接受了建議患有這種診斷的患者接受的治療，即他被轉介到州外，並接受了一系列使用內窺鏡檢查完成的治療性消融手術，該手術於上個月完成。我想，真的，我不能說比他更好的了，他直接引用了他的話，“我想我通過看到傳單並接受測試拯救了自己的生命。我很幸運我抓住了它當我感染它時。預防越多，治療就越容易。所以這確實說明了一切。”

From a commercial point of view, the opportunity here is vast. We know the number of patients. This 30 million patient population is really the core group of those who have chronic heartburn in patients who are recommended for pre-cancer testing by guidelines. Some of the guidelines have actually expanded that number beyond that.

從商業角度來看，這裡的機會是巨大的。我們知道患者的數量。這3000萬患者群體確實是指南推薦進行癌前檢測的慢性胃灼熱患者的核心群體。一些指導方針實際上已經將這個數字擴大到了這個數字之外。

Medicare has set a price that of $1,938. And as we've said on several prior calls, that price does appear to be holding as we grow our activity and increase our engagement with payers. So that's a very, very large market opportunity. And we are -- we have a very high gross margin of over 90% at volumes that are close to where we are today.

Medicare 設定的價格為 1,938 美元。正如我們在之前的幾次電話會議中所說的那樣，隨著我們擴大活動並增加與付款人的接觸，這個價格似乎確實保持不變。所以這是一個非常非常大的市場機會。我們的毛利率非常高，超過 90%，銷量接近今天的水平。

So how did we do in this past quarter from a commercial point of view? As I mentioned, EsoGuard testing volume grew 20% quarter-on-quarter to 2,200 tests. And you can see we've had just very nice, steady double-digit growth for a period of time, going back about 6 quarters.

那麼從商業角度來看，我們在過去一個季度的表現如何？正如我提到的，EsoGuard 測試量環比增長 20%，達到 2,200 次測試。你可以看到，我們在一段時間內實現了非常好的、穩定的兩位數增長，大約可以追溯到 6 個季度。

I did want to note because we get asked this a fair amount. As we're growing test volume, are we approaching capacity with regard to our laboratory or manufacturing? And that we are not. We have -- our laboratory is able to perform over 10,000 tests per quarter, and we have sufficient manufacturing capacity to keep up with that.

我確實想指出，因為我們經常被問到這個問題。隨著我們不斷增加測試量，我們的實驗室或製造是否已接近產能？但我們不是。我們的實驗室每季度能夠進行 10,000 多次測試，並且我們有足夠的製造能力來滿足這一要求。

There are still some evolving trends with regard to who is -- who are referring patients for this test and where is the cell collection portion of the test being performed? We've stabilized about 50% to 60% of the patients are being referred by primary care physicians, and the rest are being referred by a variety of specialists and institutions.

關於誰轉診患者進行這項測試以及測試的細胞收集部分在哪裡進行，仍然存在一些不斷發展的趨勢？我們已經穩定了大約 50% 到 60% 的患者由初級保健醫生轉診，其餘患者由各種專家和機構轉診。

One thing that is changing, as we continue to show increase in the number of patients that are being -- where the cell collection procedure is being performed by our nurse practitioners, and an increasing number of those are being performed at the satellite Lucid test center. So the physical Lucid test centers are the centers we have in 13 cities across the country, but we all -- we have nurse practitioners who are based there. That's their anchor. That's their home, but they are able with the satellite test centers to branch out and travel to physician offices and hold sessions there where they spend a day doing the cell collection procedure in the physician office. And we still have about 1/3 of the time patients are undergoing to test by their own physician as Steve did with his allergist.

有一件事正在發生變化，隨著我們的執業護士正在執行細胞採集程序的患者數量不斷增加，並且越來越多的患者在衛星 Lucid 測試中心進行細胞採集程序。因此，我們在全國 13 個城市設有物理 Lucid 測試中心，但我們都有駐紮在那裡的執業護士。那是他們的錨。那是他們的家，但他們可以通過衛星測試中心進行分支，前往醫生辦公室並在那裡舉行會議，在那裡他們花一天時間在醫生辦公室進行細胞收集程序。我們仍然有大約 1/3 的時間讓患者接受自己的醫生的測試，就像史蒂夫對他的過敏症專科醫生所做的那樣。

Next slide. So really great views on the commercial execution. Really proud at how the test volume is growing. If you noted that earlier in the year -- at the beginning of the year, we actually froze our sales team. And that field team, which consists of both the sales representatives, sellers as well as the clinical team, the nurse practitioners, are -- have shown increased productivity since the beginning of the year. So same number of sellers are generating this growth.

下一張幻燈片。對商業執行的看法非常好。對測試量的增長感到非常自豪。如果您在今年早些時候注意到這一點，那麼在今年年初，我們實際上凍結了我們的銷售團隊。自今年年初以來，由銷售代表、銷售人員以及臨床團隊、執業護士組成的現場團隊已經顯示出生產力的提高。因此，同樣數量的賣家正在推動這種增長。

There's improved coordination between the sales and clinical team. Some of that's driven by these high-volume testing events, which put a demand on our system. And the nurse practitioners are folks who do the EsoCheck cell collection procedure continue to hit it out of the park with a 99% technical success rate and very high sufficient D&A rates.

銷售和臨床團隊之間的協調得到了改善。其中一些是由這些大量測試事件驅動的，這對我們的系統提出了要求。執行 EsoCheck 細胞採集程序的執業護士繼續以 99% 的技術成功率和非常高的 D&A 率取得成功。

As I mentioned, the satellite Lucid test center model, the SLTC model is striving. It gives us a broader geographic reach from the home base of the physical location, much more flexibility, much more efficiency because we can assure that the nurses or nurse practitioners are there on days when there are multiple patients scheduled. And it helps with physician engagement, and it keeps the testing front and center. So that continues to be the case quarter-on-quarter, and we continue to see that positive impact.

正如我提到的，衛星Lucid測試中心模型、SLTC模型正在努力。它為我們提供了從物理位置的總部出發更廣泛的地理覆蓋範圍、更大的靈活性、更高的效率，因為我們可以確保在安排多名患者的日子裡護士或執業護士在場。它有助於醫生的參與，並使測試保持在前沿和中心位置。因此，季度環比情況仍然如此，我們繼續看到這種積極影響。

We launched our first mobile test unit in Florida. Florida is a state where the regulatory requirements required us to do that in order to have a satellite model. And the demand for that practices want us to bring demand to their parking lot where patients are tested. We get walk-ins, where patients ask for the tests that have the physician or their team order on the time.

我們在佛羅里達州推出了第一個移動測試裝置。佛羅里達州的監管要求要求我們這樣做才能擁有衛星模型。對這種做法的需求希望我們將需求帶到他們對患者進行測試的停車場。我們會定期上門，患者要求進行檢查，醫生或他們的團隊會及時安排檢查。

And it's also that marketing tool to have our bandwidth Freddy and the marketing message driving around the carving of Florida. We've been asked about expanding that and moving that in other states, and that's something we're considering. But for now, we're continuing to drive this volume here. And in other states, we don't have that mandatory need to have a mobile test unit, so we'll continue to push forward as we're doing.

這也是一種營銷工具，讓我們的帶寬弗雷迪和營銷信息在佛羅里達州的雕刻中傳播。我們被問及是否要擴大這一範圍並將其轉移到其他州，這是我們正在考慮的事情。但目前，我們將繼續推動這一銷量。在其他州，我們沒有強制要求擁有移動測試裝置，因此我們將繼續推進我們正在做的事情。

We announced the CheckYourFoodTube pre-cancer detection event. This started in the first quarter of this year. With firefighters, the growth in those activities continue. We continue to do many of these, some smaller, some larger. They continue to represent a significant portion of our volume. But importantly, again, people do inquire about this. That growth is not cannibalizing the growth in the traditional referral business from primary care physicians and other specialists. So it's additive. It's part of our philosophy of looking at every opportunity to increase access, patient access wherever it might be.

我們宣布了 CheckYourFoodTube 癌前檢測活動。這從今年第一季度開始。對於消防員來說，這些活動仍在繼續增長。我們繼續做很多這樣的事情，有的規模較小，有的規模較大。它們仍然占我們銷量的很大一部分。但重要的是，人們確實會詢問這一點。這種增長並沒有蠶食初級保健醫生和其他專家的傳統轉診業務的增長。所以它是附加的。這是我們的理念的一部分，即尋找每一個機會來增加患者的就診機會，無論患者在哪裡。

We've moved from -- although mostly firefighters, we've had police departments do this, and we're continuing to expand that reach. Again, also, it expands our geographic reach, get strong media exposure. There have been many examples where we've had a CYFT event and the physicians, including one major hospital center contacted us after hearing about a firefighter event in their region and led us to increase our activity there and divert resources there.

儘管主要是消防員，但我們已經讓警察部門來做這件事，並且我們正在繼續擴大這一範圍。同樣，它也擴大了我們的地理覆蓋範圍，獲得了強大的媒體曝光。有很多例子表明，我們舉辦了CYFT 活動，包括一家大型醫院中心在內的醫生在聽說他們所在地區的消防員活動後聯繫了我們，並促使我們增加了在那裡的活動並轉移了那裡的資源。

All of this is complicated. It takes time and some effort to get these organized and we have a dedicated program manager that's been installed and enhanced the operational efficiency substantially. So this will remain a significant part of our effort to get patients access to this test.

所有這一切都很複雜。組織這些工作需要時間和精力，我們配備了專門的項目經理，大大提高了運營效率。因此，這仍然是我們讓患者接受這項測試的努力的重要組成部分。

And we've also had an increased focus on large health systems and IDNs. These are more difficult. They take more time. There's a little more lead time. But obviously, the payoff can be large if you can get a large regional or even national health system in play. We've made progress in getting through technology clearance committees and so forth and working to translate that -- those early successes into more systematic activity within a strategic account. So we have a large pipeline of accounts that we've engaged with, and we're looking towards locking those down in the coming quarters.

我們還更加關注大型衛生系統和 IDN。這些都比較困難。他們需要更多時間。還有一點時間。但顯然，如果你能讓一個大型的地區甚至國家衛生系統發揮作用，回報可能會很大。我們在通過技術許可委員會等方面取得了進展，並努力將這些早期的成功轉化為戰略賬戶內更系統的活動。因此，我們擁有大量與之合作的賬戶，我們希望在未來幾個季度鎖定這些賬戶。

So a few comments about claims payment and coverage. These are topics that Dennis will talk about in some detail. I just wanted to highlight a few of the strategic aspects of this. If you look at the graphic on the right, I just want to remind you that there are multiple things that go towards our ability to collect payment for the tests that we perform, to get longer-term contracts that provide us coverage and ultimately, to drive revenue growth.

關於索賠支付和承保範圍的一些評論。丹尼斯將詳細討論這些主題。我只是想強調其中的一些戰略方面。如果您查看右圖，我只是想提醒您，有多種因素可以提高我們為所執行的測試收取費用的能力，獲得為我們提供保險的長期合同，並最終推動收入增長。

They include generating a claims history. You won't get paid by commercial payers until they see your tests being ordered and claims being submitted and even passing through the process of appeals and so forth. It's dependent on having a robust revenue cycle management process, dependent on generating clinical utility data, which I'll talk about in a bit more detail later. But it's a very, very critical part of our engagement with payers. The vast majority of time, their primary questions are around, have you demonstrated clinical utility. We'd like to see that.

其中包括生成索賠歷史記錄。在商業付款人看到您的測試已訂購、索賠已提交、甚至通過上訴程序等之前，您不會收到付款。它依賴於強大的收入周期管理流程，依賴於生成臨床實用數據，我稍後將更詳細地討論這一點。但這是我們與付款人互動中非常非常關鍵的一部分。絕大多數時候，他們的主要問題是，你是否證明了臨床實用性。我們希望看到這一點。

And then there's a whole discipline around market access and engaging our medical policy and all of that is another important driver. So we made substantial progress on all of them. The most important one, for the near term, is the upgrade we've made in our revenue cycle management infrastructure. We previewed this was about to happen on our last call, and that process has now been completed.

然後，圍繞市場准入和參與我們的醫療政策有一整套紀律，所有這些都是另一個重要的驅動力。因此，我們在所有這些方面都取得了實質性進展。短期內最重要的是我們對收入周期管理基礎設施進行的升級。我們在上次通話中預覽了這即將發生，並且該過程現已完成。

We engaged the market leader in Diagnostics RCM. This is a company that has a significantly larger capacity than we had. And in fact, was the -- for many years was the RCM provider for one of the largest multibillion-dollar molecular diagnostic companies.

我們聘請了診斷 RCM 領域的市場領導者。這家公司的產能比我們大得多。事實上，多年來，它一直是價值數十億美元的最大分子診斷公司之一的 RCM 提供商。

The -- we -- in order to facilitate the transition, we paused claim submissions of adjudication for about a 6-week period from the beginning of May to June 12. That had a near-term -- short-term impact on claims and receipts from that. But the immediate positive impact in July really -- was striking to all of us. That impact was positive on all fronts, including the average allowed -- the success allowed payments as well as the net average sale price. Again, Dennis will go through some of those numbers as a bit of a preview. These were obviously in this quarter, not in the prior quarter.

為了促進過渡，我們從 5 月初到 6 月 12 日暫停了索賠提交裁決大約 6 週。這對索賠和索賠產生了近期影響。從中得到的收據。但七月份立即產生的積極影響確實令我們所有人震驚。這種影響在各個方面都是積極的，包括允許的平均金額——允許付款的成功以及平均淨銷售價格。丹尼斯將再次回顧其中一些數字作為預覽。這些顯然是在本季度，而不是在上一季度。

The -- another key element to being successful with the commercial payers is the appeals and prior authorization processes. These can be quite very important. You actually have to go through appeals to get in front of medical directors to get medical necessity and other aspects of their coverage decisions to engage with them on that. That process is much more robust than it was 6 weeks ago, and we're very happy with our new partner in that regard.

與商業付款人取得成功的另一個關鍵因素是上訴和事先授權流程。這些可能非常重要。實際上，您必須通過上訴才能到達醫療主管面前，以獲得醫療必要性和他們承保決定的其他方面，以便與他們就此進行接觸。這個過程比 6 週前更加穩健，我們在這方面對我們的新合作夥伴感到非常滿意。

As I mentioned again, I'll reiterate that the drivers of payment coverage and revenue growth are still claims history and clinical utility. We've Also revamped our market access and medical policy team. We have a new strategically focused leader in this role that started yesterday, and we're looking forward to a whole variety of initiatives and engagements with payers that she will lead us to.

正如我再次提到的，我將重申支付範圍和收入增長的驅動因素仍然是索賠歷史和臨床效用。我們還重組了市場准入和醫療政策團隊。我們昨天上任了一位新的戰略重點領導者，我們期待著她將帶領我們採取各種舉措並與付款人進行接觸。

A brief comment here on our direct contracting strategic initiative. Again, we've touched on this before. This is an effort for us to go directly to employers, unions, other self-insured entities and seek to directly contract for EsoGuard services with them. That process is more effort. We have our first employer contract with a Texas-based automotive group. We'll be providing more information on that in the coming weeks. But it's the first time that EsoGuard is now -- is being offered as an employee benefit through our satellite test program at 12 locations with this automotive group. So we're very, very happy that we've achieved that milestone, and we look forward to more.

這裡對我們的直接承包戰略舉措進行簡要評論。同樣，我們之前已經談到過這個問題。這是我們直接與雇主、工會和其他自保實體聯繫並尋求直接與他們簽訂 EsoGuard 服務合同的努力。這個過程需要付出更多的努力。我們與一家位於德克薩斯州的汽車集團簽訂了第一份雇主合同。我們將在未來幾週內提供更多相關信息。但這是 EsoGuard 現在第一次通過我們在該汽車集團 12 個地點的衛星測試計劃作為員工福利提供。因此，我們非常非常高興我們已經實現了這一里程碑，並且我們期待更多。

The timing on these, like, the strategic accounts can be longer and they can cycle with open enrollment periods and so forth, but we're pushing forward quite aggressively. And we actually are hiring someone to be a director in this role.

這些項目的時間安排，例如戰略賬戶，可以更長，並且可以與開放註冊期等循環，但我們正在積極推進。我們實際上正在聘請某人擔任該職位的總監。

Okay. I've already mentioned clinical utility. Let me mention it again, because this is really at the heart of our efforts to engage with our commercial payers -- with payers and in order to drive and network coverage. Clinical utility means that our test is -- has an impact on medical decision-making.

好的。我已經提到過臨床實用性。讓我再次提及這一點，因為這確實是我們與商業付款人接觸的努力的核心——與付款人接觸，以推動網絡覆蓋。臨床實用性意味著我們的測試對醫療決策有影響。

What a payer wants to know is that if our test is positive, that, that will result in a follow-up test, a follow-up endoscopy to demonstrate that -- to confirm that -- to confirm the diagnosis and generate a follow-up plan, either surveillance, ablation or some other treatment. They also want to know that if a test is negative, that the patient won't more than likely not get another expensive test like an endoscopy.

付款人想知道的是，如果我們的測試呈陽性，那將導致後續測試、後續內窺鏡檢查，以證明——確認這一點——確認診斷並產生後續結果——制定計劃，包括監測、消融或其他治療。他們還想知道，如果測試結果呈陰性，患者很可能不會接受另一項昂貴的測試，例如內窺鏡檢查。

So that fork in the road is actually very straightforward for our test. It's actually more complicated than some other diagnostic tests. It's quite straightforward and it's really the algorithm I just mentioned. The key type of data that the payers are looking for is prospective data. And so as we've discussed before, we have 2 studies, the CLUE study, which is a prospective multicenter study and the Lucid Registry, which is dominated by our own patients coming through our listed test centers. Both of those are prospective.

所以對於我們的測試來說，這個岔路口實際上非常簡單。它實際上比其他一些診斷測試更複雜。非常簡單，這就是我剛才提到的算法。付款人尋找的關鍵數據類型是預期數據。正如我們之前討論的，我們有兩項研究，CLUE 研究，這是一項前瞻性多中心研究，而 Lucid 登記研究，主要由來自我們列出的測試中心的我們自己的患者主導。這兩個都是有前景的。

We had target enrollments for the mid-summer that we've exceeded both. We have a total of over 500 patients between the 2. That is sufficient for us to analyze the data, submit it for -- posted on a preprint server and submit it for peer review by the end of this month, and we look forward to doing that.

我們設定了仲夏的入學目標，但我們已經超過了這兩個目標。兩者之間總共有超過 500 名患者。這足以讓我們分析數據，將其提交到預印本服務器上，並在本月底之前提交供同行評審，我們期待這樣做。

That is the process by which we will be able to highlight that data for payers and engaging in coverage discussions, demonstrations of medical necessity and negotiations for in-network contracting. So that process is ready to go. We're going to have our first set of data, and we're going to be able to present that to payers in the very near future.

通過這個過程，我們將能夠向付款人強調這些數據，並參與保險範圍討論、醫療必要性演示以及網絡內合同談判。所以這個過程已經準備好了。我們將擁有第一組數據，並且我們將能夠在不久的將來將其呈現給付款人。

We also have the retrospective analysis from the very first high-volume testing event and the San Antonio Firefighters. That's retrospective. So it's not as powerful, but it is useful. And the data on that was excellent. The percentage of very, very high concordance with the outcome of the test and the appropriate medical decision being made for the test, as I described previously. That manuscript was submitted, and it's undergoing peer review in the gastroenterology journal.

我們還對第一次大容量測試活動和聖安東尼奧消防員隊進行了回顧性分析。那是回顧性的。所以它的功能雖然不是那麼強大，但是很有用。這方面的數據非常好。正如我之前所描述的，與測試結果非常非常高的一致性以及為測試做出的適當醫療決定的百分比。該手稿已提交，正在胃腸病學雜誌上接受同行評審。

Another useful type of test that is commonly used in these kinds of discussions with payers are virtual patient studies where you recruit patients -- you recruit physicians to give their decision as to what they would do in a very structured vignette fashion. That is -- study is ongoing recruitment, and we're looking forward to closing that in the near future as well. That will be a nice supplemental piece of data, but the central data will be from the CLUE study and the Registry.

在與付款人的此類討論中常用的另一種有用的測試類型是虛擬患者研究，您可以在其中招募患者 - 您招募醫生以非常結構化的小插圖方式做出他們將做什麼的決定。也就是說，研究正在進行中，我們也期待在不久的將來完成招募。這將是一個很好的補充數據，但核心數據將來自 CLUE 研究和註冊表。

That's clinical utility. I won't be talking in much depth about the clinical validity studies. Those are studies that just continue to document the performance of our assay -- or our test as was published originally in science translational medicine years ago. So there are 5 studies, the BETRNet study, the VA study, which we've previously announced. The BE study -- BE1 study, which is a study that we enrolled about 150 patients in before pausing. That data is being analyzed.

這就是臨床實用性。我不會深入討論臨床有效性研究。這些研究只是繼續記錄我們的測定的性能——或者我們的測試，正如幾年前最初在科學轉化醫學中發表的那樣。我們之前宣布了 5 項研究，BETRNet 研究和 VA 研究。 BE 研究——BE1 研究，這是一項我們在暫停之前招募了大約 150 名患者的研究。正在分析該數據。

The BE2 study is another case control study that we're continuing to roll into, and we'll likely have a readout in the first half of next year. And Case Western Reserve also has a non-GERD study that's ongoing in its enrollment. I won't talk on the details of those except for a brief highlight of the BETRNet results from the NCI. I'm just going to give a brief summary of that. We plan on providing more information on that in the coming weeks as well.

BE2 研究是我們正在繼續開展的另一項病例對照研究，我們可能會在明年上半年公佈結果。凱斯西儲大學還有一項正在進行的非 GERD 研究。除了簡要介紹 NCI 的 BETRNet 結果之外，我不會談論這些細節。我將對此做一個簡短的總結。我們也計劃在未來幾週內提供更多相關信息。

So the BETRNet study -- BETRNet is a consortium of major academic medical centers. They're really the leading figures in esophageal disease and esophageal pre-cancer. You can see venerated names on the right there, Case Western, Mayo Clinic, Hopkins, WashU, UNC and Cleveland Clinic all participated in the study. It was a case control study of endoscopy versus our EsoGuard test. This is the first study that used a real-world use of the testing with our standard room temperature preservative. The previous study was more of a research study and in frozen samples. So that was a very important milestone for us to achieve. 100% of the patients in the study underwent EsoCheck cell collection. And again, that wasn't true in the original Science Translational Medicine paper.

BETRNet 研究——BETRNet 是一個由主要學術醫學中心組成的聯盟。他們確實是食管疾病和食管癌前期的領軍人物。你可以在右邊看到一些受人尊敬的名字，凱斯西儲大學、梅奧診所、​​霍普金斯大學、華盛頓大學、北卡羅來納大學和克利夫蘭診所都參與了這項研究。這是一項內窺鏡檢查與我們的 EsoGuard 測試的病例對照研究。這是第一項使用我們的標準室溫防腐劑進行實際測試的研究。之前的研究更多的是一項研究性研究，並且是在冷凍樣本中進行的。所以這對我們來說是一個非常重要的里程碑。研究中 100% 的患者接受了 EsoCheck 細胞採集。再說一遍，最初的《科學轉化醫學》論文中的情況並非如此。

You can see the numbers there. I won't go through the full breakdown of the patients, but they started with about 365 patients that had at the end 242 that were evaluable. I will highlight two numbers on that, the 83% technical access rate and the 72% overall success rate.

你可以在那裡看到數字。我不會詳細介紹患者的情況，但他們從大約 365 名患者開始，最後有 242 名患者可以評估。我將重點強調兩個數字，即 83% 的技術訪問率和 72% 的總體成功率。

Just to note that these results which are excellent, and I'll show on the next slide, occurred despite the fact that the overall success rates were lower than we would like. These were centers that were doing this a bit earlier in our experience in centers that did not have the same rigorous competency training that we have now for academic centers, but predominantly for our own nurse practitioners.

請注意，儘管總體成功率低於我們的預期，但我將在下一張幻燈片中展示這些非常出色的結果。根據我們的經驗，這些中心在這方面做得比較早，它們沒有像我們現在的學術中心那樣嚴格的能力培訓，但主要是針對我們自己的執業護士。

So I highlighted earlier that our in-house Lucid test center technical success rate is 99%, which is substantially better than the 83% here, and our overall success is about 95%. Again, substantially better than 72%. So we believe that the excellent results that are reported here are likely to be better given the current benchmark for the overall success of the test.

所以我之前強調過，我們內部 Lucid 測試中心的技術成功率為 99%，比這裡的 83% 好很多，我們的總體成功率約為 95%。再次明顯好於 72%。因此，我們相信，考慮到當前測試總體成功的基準，此處報告的出色結果可能會更好。

So one last slide here which has the results -- the headline results from this test. And I'll caveat before I go into some detail that we are showing some other comparable early cancer detection as targets. These are not head-to-head comparisons.

最後一張幻燈片顯示了結果——本次測試的標題結果。在詳細介紹之前，我要警告一下，我們正在展示一些其他類似的早期癌症檢測作為目標。這些不是直接比較。

What I'd like to show here is what other highly successful or expected to be successful or early cancer detection test, the metrics that were used -- the performance metrics that were used that led to them being approved, FDA approved, getting coverage and being -- while at being certainly Cologuard test widely successful.

我想在這裡展示的是其他非常成功或預期成功或早期癌症檢測測試，所使用的指標——所使用的績效指標，導致它們被批准、FDA 批准、獲得覆蓋和Cologuard 測試確實取得了廣泛的成功。

Many of those were screening studies in their intended use population. The EsoGuard results are a case-control study. That said, EsoGuard picked up 100% of the cancers, which is, as you can see there, obviously, Cologuard does quite well in that regard.

其中許多是針對其預期使用人群的篩選研究。 EsoGuard 結果是一項病例對照研究。也就是說，EsoGuard 檢測出了 100% 的癌症，正如您所看到的，顯然 Cologuard 在這方面做得相當好。

The Guardant, which is the liquid biopsy blood test that's getting a lot of attention is at 83%. And in Stage one, those numbers are quite poor at 55%. All of the 100% cancers that were detected by EsoGuard were Stage I cancers.

Guardant 是備受關注的液體活檢血液測試，其準確率為 83%。在第一階段，這些數字非常低，僅為 55%。 EsoGuard 檢測到的所有 100% 癌症均為 I 期癌症。

The greater picture is on the pre-cancer side. The 81% detection rate for pre-cancer is really unprecedented for a molecular diagnostic test. Cologuard picks up, advanced at a moment at about a 42% clip. That number is a bit better in our most recent study. The blood test for cancer hardly at all 13% for Guardant. So this 82% -- this 81% number, and then the overall 85% number, which is dominated by the pre-cancers, is really, again, quite unprecedented and critical for this cancer.

更大的圖景是在癌症前期。 81%的癌前病變檢出率對於分子診斷測試來說確實是史無前例的。 Cologuard 開始行動，並以大約 42% 的速度前進。在我們最近的研究中，這個數字要好一些。 Guardant 的血液癌症檢測結果幾乎沒有 13%。所以這個 82%——這個 81% 的數字，然後是由癌前病變主導的總體 85% 的數字，對於這種癌症來說確實是前所未有的和至關重要的。

Picking up a Stage 1 colon cancer, as I mentioned, has an opportunity for a cure. We have to -- we have no choice but to have the cancer detection rate in the 80% range, and we're gratified that, that number is holding.

正如我提到的，患上第一期結腸癌有機會治愈。我們必須——我們別無選擇，只能將癌症檢出率保持在 80% 的範圍內，我們很高興這一數字得以保持。

There's some additional numbers on the right, I won't go through all 3 of them, but the negative predictive value is -- it's a good gut check. That's an estimated number based on what we expect the prevalence to be. That's at 99%. And that's where it needs to be for a test that's trying to pick up cancer or pre-cancer in the setting. You don't want to miss any, although that 1% is the 1% overall miss rate, including pre-cancers.

右邊還有一些額外的數字，我不會一一列舉所有 3 個數字，但陰性預測值是——這是一個很好的直覺檢查。這是根據我們預期的患病率估算的數字。那是99%。這就是試圖在環境中發現癌症或癌前病變的測試所需要的地方。您不想錯過任何一個，儘管 1% 是 1% 的總體錯過率，包括癌前病變。

Again, very comparable, if not better than what the benchmark is for others. So with that, I will hand the baton over to Dennis, who will give some summary of our financial results.

同樣，即使不比其他基準更好，也非常具有可比性。因此，我將把接力棒交給丹尼斯，他將對我們的財務業績進行一些總結。

Thanks, Lishan. The summary financial results for the second quarter and the first half of the year, we reported a press release that was published last night.

謝謝，李山。我們昨晚發布了一份新聞稿，報告了第二季度和上半年的財務業績摘要。

On these next 3 slides, I'll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q was filed with the SEC last night and is available on our website.

在接下來的 3 張幻燈片中，我將強調本季度的一些關鍵亮點，但我鼓勵您在昨晚向 SEC 提交的 10-Q 表格季度報告中涵蓋的完整披露內容中考慮這些言論並可在我們的網站上找到。

So on Slide 16, here is our balance sheet. Cash, $32.6 million, reflects a sequential burn rate of $6.9 million. The burn rate in the first quarter was about the same at $6.6 million. Obviously, the simple math suggests that if this rate is sustained, it puts our runway to more than a year.

在幻燈片 16 中，這是我們的資產負債表。現金為 3260 萬美元，連續燒錢率為 690 萬美元。第一季度的燒錢率大致相同，為 660 萬美元。顯然，簡單的數學表明，如果這個速度持續下去，我們的跑道將持續一年以上。

The burn rate is softened by the -- by PAVmed's currently deferring payment of the quarterly management services agreement, which creates optionality for paying the outstanding intercompany obligation in stock or cash, which is at PAVmed's future election. Furthermore, as cash collections continue to accelerate, as we'll talk about in a second, this can further throttle the burn rate for the upcoming quarters. Vendor payables were flat for the sequential quarter as was also the case in the first quarter. So the burn rate is not substantially influenced by changes in key net working capital balances.

燒錢率因 PAVmed 目前推遲支付季度管理服務協議而有所緩和，這為以股票或現金支付未償公司間債務創造了選擇，這是 PAVmed 未來的選擇。此外，隨著現金回收繼續加速（我們稍後將討論），這可能會進一步抑制未來幾個季度的資金消耗率。與第一季度的情況一樣，第二季度的供應商應付賬款持平。因此，燒錢率不會受到主要淨營運資本餘額變化的重大影響。

The intercompany debt the PAVmed increased by $3.1 million, for which $2.3 million is the quarterly shared services charges. The shares outstanding, including unvested restricted stock awards as of today, is 43.7 million shares, which is substantially unchanged from the first quarter. The GAAP outstanding shares are reflected on the slide as well as the face of the balance sheet in the 10-Q.

PAVmed 的公司間債務增加了 310 萬美元，其中 230 萬美元是季度共享服務費用。截至今日，已發行股票（包括未歸屬的限制性股票獎勵）為 4,370 萬股，與第一季度基本持平。 GAAP 流通股反映在幻燈片以及 10 季度資產負債表的表面上。

On the next slide, Slide 17, compares this year's second quarter to last year's second quarter and similarly for the 6-month totals on certain key items. Thus, I will review the information in my comments in light of the cautionary disclosure in the bottom of the slide about supplemental information, particularly non-GAAP information. I'm required to say that.

在下一張幻燈片（幻燈片 17）中，將今年第二季度與去年第二季度進行了比較，並對某些關鍵項目的 6 個月總計進行了類似的比較。因此，我將根據幻燈片底部有關補充信息（特別是非公認會計準則信息）的警告性披露來審查我的評論中的信息。我必須這麼說。

Revenue for the second quarter reflects actual cash collections for the quarter, plus invoice EsoGuard test to the VA. With regard to the prior year, you will recall, there was a 6 monthly fee received from the third-party lab that we used before setting up our own lab, and that agreement terminated in February of '22.

第二季度的收入反映了該季度的實際現金收款，以及 VA 的發票 EsoGuard 測試。就前一年而言，您可能還記得，我們在建立自己的實驗室之前，從我們使用的第三方實驗室收取了 6 個月的費用，該協議於 22 年 2 月終止。

You'll recall from our discussion on last quarterly call and the comments that Lishan made that we made a major change in upgrade to our revenue cycle management company. We determined the best way to manage that transition was to stop submitting claims for reimbursement at the beginning of May to allow Quadax to come on board, which they did in mid-June, and more effectively handle processing and reporting on the claims we had in here. And I'll give you some statistics that we had here.

您會記得我們在上個季度電話會議上的討論以及李山的評論，我們在升級為收入周期管理公司方面做出了重大改變。我們確定管理這一過渡的最佳方法是在 5 月初停止提交報銷索賠，以允許 Quadax 加入（他們在 6 月中旬這樣做），並更有效地處理和報告我們在這裡。我會給你一些我們在這裡的統計數據。

So far in the short period of time, just since the beginning of the third quarter, collections for third-party reimbursement claims have tripled what was collected in the entire previous quarter. As a reminder, revenue recognition, a key determinant is the probability of collection. And therefore, due to the fact that we are in the early stages of our reimbursement process, this means revenue recognition occurs when the claim is actually collected.

到目前為止，在第三季度初以來的短時間內，第三方報銷索賠的收款額已是上一季度整個季度收款額的三倍。提醒一下，收入確認的一個關鍵決定因素是收取的概率。因此，由於我們處於報銷流程的早期階段，這意味著收入確認是在實際收取索賠時發生的。

First, when the patient report is invoice and submitted reimbursement. As you'll see in our 10-Q, this is called variable consideration in the jargon of GAAP's ASC 606 revenue recognition guidelines. And presently, there is insufficient predictive data to reflect revenue when the test report is delivered to the referring physician. However, Quadax is developing that database for us to eventually change from cash collection recognition to when the service is delivered.

首先，當患者報告是發票並提交報銷時。正如您將在我們的 10-Q 中看到的，這在 GAAP 的 ASC 606 收入確認指南的行話中稱為可變對價。目前，當測試報告交付給轉診醫生時，沒有足夠的預測數據來反映收入。然而，Quadax 正在為我們開發該數據庫，以便最終從現金收款識別轉變為服務交付時間。

Our non-GAAP loss for the second quarter of $9.6 million reflects a 2.4% sequential decrease compared to the first quarter loss and approximately a 10% decrease from the fourth quarter of last year as a result of the cost control initiatives we put in place at the beginning of the year.

我們第二季度的非GAAP 虧損為960 萬美元，與第一季度虧損相比環比下降2.4%，與去年第四季度相比下降約10%，這是我們在2019 年實施的成本控制舉措的結果。年初。

The next slide, Slide 18, is the graphic illustration of our operating expenses for the periods reflected. Total non-GAAP OpEx of $9.7 million for the second quarter of '23 reflects a sequential decrease of 11.3%. However, in our last quarterly call, we mentioned that in the first quarter, there were approximately $1.2 million of certain onetime expenses as we rationalized our base level expenses.

下一張幻燈片（幻燈片 18）是我們所反映期間的運營費用的圖解說明。 2023 年第二季度的非 GAAP 運營支出總額為 970 萬美元，環比下降 11.3%。然而，在我們上一季度的電話會議中，我們提到，在第一季度，隨著我們合理化基本水平費用，某些一次性費用約為 120 萬美元。

Taking into account these measures, the normalized OpEx levels for both first quarter and second quarter are about even with each other. And both reflect a 9% decrease from the fourth quarter of last year, again, as a result of the cost controls we put in place at the beginning of the year.

考慮到這些措施，第一季度和第二季度的標準化運營支出水平大致持平。兩者均比去年第四季度下降了 9%，這也是我們在年初實施的成本控制的結果。

Except for cost of revenue, all OpEx categories were flat or lower, contributing to the overall sequentially lower expenses. Cost of revenue primarily consists of EsoCheck devices, lab supplies and fixed lab facility costs. The non-GAAP loss is slightly better sequentially by $0.01 per share and significantly lower than last year's fourth quarter, about $0.10 per share, which was again the last quarter before putting the cost controls in place at the beginning of the year.

除收入成本外，所有運營支出類別均持平或較低，導致總體費用環比下降。收入成本主要包括 EsoCheck 設備、實驗室用品和固定實驗室設施成本。非 GAAP 虧損比上一季度略好，每股虧損 0.01 美元，明顯低於去年第四季度每股約 0.10 美元，這也是年初實施成本控制之前的最後一個季度。

On a GAAP basis, the net loss per share improved from $0.40 loss per share to $0.27 per share, reflecting a $4.9 million decrease in our sequential net loss. Contributing to this $4.9 million improvement, about 1/2 came from financing-related activities in the first quarter, and the remainder was a general reduction in OpEx, mainly stock-based comp and other noncash charges.

按照 GAAP 計算，每股淨虧損從每股虧損 0.40 美元改善至每股 0.27 美元，反映出我們連續淨虧損減少了 490 萬美元。促成這 490 萬美元改善的因素是，大約 1/2 來自第一季度的融資相關活動，其餘部分是運營支出的普遍減少，主要是基於股票的補償和其他非現金費用。

Now as promised, some statistics in the market access. First, the split between commercial and Medicare. Medicaid was in the past about 92%, 8% Medicare and Medicaid. Not significantly higher. It's about 82%, 17% split. So a little bit higher on the Medicare, Medicaid, but not substantial change.

現在正如所承諾的那樣，一些市場准入的統計數據。首先，商業保險和醫療保險之間的劃分。過去Medicaid大約是92%，Medicare和Medicaid是8%。並沒有明顯升高。大約是82%、17%。所以醫療保險、醫療補助上有點高，但沒有實質性的改變。

Since Quadax took over an indication of some of the statistics that they provide us that we continue to monitor the performance since May 1 through August 14, a period of time that Quadax submitted claims. You remember we stopped submitting with Synergene on May 1. They submitted just over 2,000 claims -- 2,100 claims. Of those, less than half, 943 have been adjudicated.

由於 Quadax 接管了他們向我們提供的一些統計數據，我們將繼續監控 5 月 1 日至 8 月 14 日（Quadax 提交索賠的一段時間）的表現。您還記得我們於 5 月 1 日停止向 Synergene 提交申請。他們提交了 2,000 多個索賠——2,100 個索賠。其中，943 起案件已得到裁決，不到一半。

And is a term we're going to use a lot going forward. Out of the claims that were adjudicated, a decision or an allowance of the amount to be paid with 349 claims, 37%. Importantly, the amount that was allowed when those claims that were adjudicated and determined to be allowed, has increased from past quarters, it presently is just under $1,900, $1,890. This represents the insurance company's payment rate.

這是我們今後將經常使用的術語。在已裁決的索賠中，有 349 起索賠作出決定或給予支付金額，佔 37%。重要的是，當這些索賠被裁定並確定允許時，允許的金額比過去幾個季度有所增加，目前略低於 1,900 美元、1,890 美元。這代表了保險公司的賠付率。

It does not take into account individual patient's deductible or co-pay. It's the allowance. But it's an indication that they are respecting the payment rate, the Medicare level. And so yes, a lot of payments are considered out of network, but we're going to focus on allowance going forward because we think that levels the playing field from quarter-to-quarter to determine progress being made on the insurance level.

它不考慮個別患者的免賠額或自付費用。就是津貼。但這表明他們尊重支付率和醫療保險水平。所以，是的，很多付款都被認為是在網絡之外，但我們將重點關注未來的津貼，因為我們認為每個季度的競爭環境都是公平的，以確定保險水平方面取得的進展。

So with that, operator, let's open it up for questions.

那麼，操作員，讓我們開始提問吧。

(Operator Instructions) The first question today comes from Kyle Mikson with Canaccord.

（操作員說明）今天的第一個問題來自 Canaccord 的 Kyle Mikson。

So good -- congrats on the volume. Nice to see the solid increase sequentially. And I think I understand the -- what happened here with the RCM provider and the switch here, and it sounds good in July going forward. Can you possibly quantify the volume that was lost during period in May and June and then early like qualitatively? And then just maybe confirm if you can recapture that revenue maybe during the remainder of 2023?

太好了——恭喜你的銷量。很高興看到連續的穩步增長。我想我理解——RCM 提供商和這裡的切換所發生的事情，而且 7 月份的情況聽起來不錯。您能否對 5 月和 6 月期間以及早期的損失量進行定性量化？然後確認您是否可以在 2023 年剩餘時間內重新獲得該收入？

Yes. None of those claims were lost. Quadax just picked up all of those -- we actually suspended those claims and waited for Quadax to be online and they reached back to that date. That's why the statistics I just gave from May 1 to August 14, represents the claims that they submitted, some of which were from May to June 30 and then the balance since that time.

是的。這些索賠均未丟失。 Quadax 剛剛收到了所有這些 - 我們實際上暫停了這些索賠並等待 Quadax 上線，然後他們回到了那個日期。這就是為什麼我剛才給出的從5月1日到8月14日的統計數據代表了他們提交的索賠，其中一些是從5月到6月30日，然後是從那時起的餘額。

And that total in that period of time was a little over 2,000. So not submitting May 1, and that gets picked up in June 12, and they submitted all of the backlog.

那段時間的總數略多於 2000 人。因此，沒有在 5 月 1 日提交，而是在 6 月 12 日恢復，他們提交了所有積壓的訂單。

Yes. So no, just to use your term, no claims were lost and no test volume was lost. Obviously, those...

是的。所以不，用你的術語來說，沒有索賠丟失，也沒有測試量丟失。顯然，那些...

That resulted in timing of collections, but not in loss test.

這導致了收集的時間安排，但沒有導致損失測試。

Right. I should have said shifted to the, I guess, second half of the year. But I heard your stat at the end there, Dennis. I was just confirming if that was what you were talking about? That's perfect. That's great.

正確的。我應該說轉移到了，我想，下半年。但我聽到了你最後的統計數據，丹尼斯。我只是想確認一下你說的是不是這個？那很完美。那太棒了。

In terms of the high-volume testing impact in the quarter, maybe just walk through that and maybe talk about how we're thinking about that going forward? If it's recurring and organic revenue kind of growth source? Or is it still to subside and we shouldn't really expect any of what's happening going forward?

就本季度的大量測試影響而言，也許只是簡單介紹一下，然後談談我們如何考慮未來的情況？如果它是經常性和有機收入的增長來源？還是說它仍然會消退，我們真的不應該期待未來會發生什麼？

I think it's upside, but it's also a key part of our growth. So in the first quarter, the first quarter total had about 450 tests from those high-volume events, CheckYourFoodTube events, and it was slightly higher in the second quarter, about 8% or 9% growth. So to get to your question, the organic growth of non-test events was around 23%, for an overall blend of 20%.

我認為這是有好處的，但這也是我們增長的關鍵部分。因此，在第一季度，第一季度總共有大約 450 次測試來自那些大容量事件，CheckYourFoodTube 事件，第二季度略高，大約增長 8% 或 9%。因此，回答你的問題，非測試活動的有機增長約為 23%，總體混合增長率為 20%。

Yes. And that's consistent with the strategy now, right? We said this before and I would say it again that we're not shifting from one strategy to other. This is all of the above strategy. Any opportunity we have to get patient's access, we're seeking them. And these high-volume events are very productive tool for us.

是的。這與現在的策略是一致的，對吧？我們之前說過這一點，我想再說一遍，我們不會從一種戰略轉向另一種戰略。這就是以上所有的策略。我們正在尋找任何讓患者接觸的機會。這些大容量活動對我們來說是非常富有成效的工具。

It's a different modality. It's typically one physician where we find a physician champion, we find a group. As I said, we started with firefighters, but we're diversified beyond that. And we find a real interest and need and demand for doing these tests, and we can do them in a very efficient way because our nurse practitioners can do 30 of these per MP per day.

這是一種不同的方式。通常，我們會找到一名醫生冠軍，然後找到一個團隊。正如我所說，我們從消防員開始，但除此之外我們還多元化。我們發現了進行這些測試的真正興趣、需要和要求，並且我們可以以非常有效的方式進行這些測試，因為我們的執業護士每天可以為每個 MP 做 30 次這樣的測試。

So it will remain an important role. We've really fine-tuned our comp plans to make sure that we're not cannibalizing one for the other. So there's still the same incentive to drive the individual sort of boots on the ground, physician-driven referrals. And we expect to see growth in both.

因此，它將繼續發揮重要作用。我們確實對我們的補償計劃進行了微調，以確保我們不會互相蠶食。因此，仍然有同樣的動機來推動個人類型的靴子在實地，由醫生驅動的轉診。我們預計兩者都會增長。

Okay. Awesome. And Lishan, one for you on the prior authorization process. EsoGuard is such a novel kind of diagnostic. And EsoCheck as well, the procedure itself pretty new, it's been in the market for like 2 or 3 years. How is the receptiveness and the expediency progressed until you started submitting claims to commercial and private payers a few years ago? And what are the point of pushback for these kind of like key gatekeepers here?

好的。驚人的。 Lishan 為您提供了有關事先授權流程的信息。 EsoGuard 是一種新穎的診斷方法。還有 EsoCheck，該程序本身相當新，它已經上市 2 或 3 年了。在您幾年前開始向商業和私人付款人提交索賠之前，接受度和便利性進展如何？對於這些關鍵看門人來說，抵制有什麼意義呢？

It's multifaceted. As you know, these are the whole commercial payer process is very -- can be complex. It could be very diverse with regard to how people engage I'll just put at the top that for the larger sort of the kind of the big in-network contract, the wholly the home run, so to speak, that is the commentary is always about clinical utility, come back to us when you have sufficient clinical utility.

它是多方面的。如您所知，整個商業付款流程可能非常複雜。關於人們的參與方式可能會非常多樣化，我只是將其放在首位，對於較大類型的大型網絡內合同，可以說是全壘打，這就是評論始終關注臨床實用性，當您有足夠的臨床實用性時再來找我們。

But that's not to say that, as Dennis said, we're actually with an upgraded provider that's helping us engage with payers on a claim-by-claim basis. Many of those interactions are, like you said, they involve even if they get denied initially, there's an appeal.

但這並不是說，正如丹尼斯所說，我們實際上擁有升級後的提供商，可以幫助我們在逐項索賠的基礎上與付款人互動。正如您所說，許多互動涉及即使最初被拒絕，也會提出上訴。

And the appeal often is -- we see that as an opportunity to engage with the medical directors on a peer-to-peer basis and have an opportunity to educate them on the importance of the test and so forth. So we're having more engagement. The volume has gone up and more interaction with medical directors. And there's certainly been great progress over the last 6 weeks in terms of how those conversations are going and the proportion of the -- that are resulting in the lab claims. So early -- still early, but it really does bode well and quite excited for the coming quarters.

吸引力往往是——我們認為這是一個與醫療主管進行點對點交流的機會，並有機會向他們介紹測試的重要性等。所以我們有更多的參與。數量增加了，與醫療主任的互動也增加了。過去 6 週以來，在這些對話的進展情況以及導致實驗室索賠的比例方面，確實取得了巨大進展。這麼早——還早，但這確實是一個好兆頭，對未來幾個季度來說非常令人興奮。

Quadax has a very sophisticated appeals process, and they are just getting started. So I had already indicated they processed just over 2,000 claims since May 1. Only about 200 are in the appeals process, and they're just getting started to increase that level. And we have also found that the #1 and #2 reasons for denial. One is medically not necessary, which is [toggles] our mind given the guidelines that are out there to establish that. And the other is...

Quadax 擁有非常複雜的上訴流程，而他們才剛剛開始。所以我已經表示，自 5 月 1 日以來，他們處理了超過 2,000 份索賠。只有大約 200 份處於上訴程序中，而且他們剛剛開始提高這一水平。我們還發現了拒絕的#1 和#2 原因。其中一個在醫學上是不必要的，考慮到現有的指導方針來確定這一點，這[改變了]我們的想法。另一個是...

But often those are just -- like those are often just the label that had an administrative person's laps down, and that's an opportunity to have a conversation with a medical director to actually make the case that it is.

但通常這些只是——就像那些通常只是讓行政人員失望的標籤一樣，這是一個與醫療主管進行對話的機會，以實際證明這一點。

And that's where the appeal process comes in. And ultimately, that will be cured by a network coverage, right? And then the second is it's noncovered routine screening exam, which again is comprehensible, given the history and the guidelines, the risk factors. These patients have to demonstrate before they can get tested. So that will change in time.

這就是上訴程序的用武之地。最終，這將通過網絡覆蓋來解決，對吧？第二個是非覆蓋的常規篩查檢查，考慮到歷史、指南和風險因素，這也是可以理解的。這些患者必須在接受檢測之前進行證明。所以這會隨著時間的推移而改變。

Perfect. Just one before I hop off. The Lucid Registry and the multi-center CLUE studies, when -- what is the expected timing for the peer-reviewed publication for that? Like do you think that, that would be published within like a year from now?

完美的。下車前只需一張。 Lucid 註冊中心和多中心 CLUE 研究，同行評審出版物的預期時間是什麼時候？您認為該文章會在一年後發布嗎？

Certainly within a year, yes. But thanks for giving me a broad range here because the peer review can be a little bit hard to predict, right? We are committed to -- this has become good practice. Now we are committed to as soon as we have manuscript script complete and the data fully scrubbed to post it on a preprint server while the peer review process is going on.

當然是一年之內，是的。但感謝您在這裡給我一個廣泛的範圍，因為同行評審可能有點難以預測，對吧？我們致力於——這已成為良好實踐。現在，我們致力於在同行評審過程進行的同時，一旦稿件腳本完成並且數據得到充分清理，就將其發佈到預印本服務器上。

And so that actually does provide us with an actual manuscript that we can have -- we can initiate conversations in. So -- it's a little bit hard to say. Clinical utility studies are not often like a traditional clinical studies. So a little bit hard to know how long it will take to get to clear peer review. But we'll have plenty of opportunity during the peer review process to use the preprint manuscript to engage conversations with payers.

所以這實際上為我們提供了一份我們可以擁有的實際手稿——我們可以在其中發起對話。所以——這有點很難說。臨床效用研究通常與傳統的臨床研究不同。因此，很難知道需要多長時間才能通過同行評審。但在同行評審過程中，我們將有很多機會使用預印本手稿與付款人進行對話。

The next question comes from Mike Matson with Needham & Co.

下一個問題來自 Needham & Co. 的 Mike Matson。

Just one on -- just with the new revenue cycle management process or a partner, I guess, how long do you think it's going to take until you can shift from billing on collections to -- sorry, recording revenue recognizing revenue on collections to submissions, I guess, of claims.

只是一個 - 只是通過新的收入周期管理流程或合作夥伴，我想，您認為需要多長時間才能從收款計費轉變為 - 抱歉，記錄收入確認收款收入到提交，我猜，是索賠。

That's hard to determine, Mike. I know from other companies that process could be anywhere from 6 months to 2 years, and it really depends upon where we -- the speed of which things change from out-of-network to in-network and contracts and being paid by contract.

這很難確定，邁克。我從其他公司了解到，這個過程可能需要 6 個月到 2 年不等，這實際上取決於我們的位置——事物從網絡外轉變為網絡內、合同以及按合同付款的速度。

It all comes down to the predictability of when we submit a claim to a third party, the likelihood of getting that amount paid and adding some degree of intelligence to that based upon historical data. Quadax will give us the data that once it's sufficient, we can make that change, but it's hard to predict. And I can only use past companies in terms of that time line to kind of give you a range of an answer. But it's becoming more and more sophisticated for us, and we'll know when we know over the next couple of quarters.

這一切都取決於我們何時向第三方提交索賠的可預測性、獲得支付金額的可能性以及根據歷史數據添加一定程度的情報。 Quadax 將為我們提供數據，一旦數據足夠，我們就可以進行更改，但這很難預測。我只能用過去的公司的時間線來給你一系列的答案。但對我們來說，它變得越來越複雜，當我們在接下來的幾個季度知道時我們就會知道。

Yes, I understand. And once that happens, what just be basically, like you have a history of getting paid on x percent of your submissions. So you're able to record that fraction as revenue or something like that?

是的我明白。一旦發生這種情況，基本上就像您有通過提交的 x% 獲得報酬的歷史記錄一樣。那麼你可以將這一部分記錄為收入或類似的東西嗎？

That is correct. So when the key determinant of when the service is delivered is when our lab submits the report to the referring physician. That will be the point of recognition. It is now the point of recognition, but there's one other consideration. At that point, we have to take into account is what is the likelihood of getting paid at the billed amount and that's the unpredictable piece.

那是對的。因此，何時提供服務的關鍵決定因素是我們的實驗室何時向轉診醫生提交報告。這將是認可點。現在這是認可的重點，但還有另一個考慮因素。那時，我們必須考慮按賬單金額獲得付款的可能性有多大，這是不可預測的部分。

So going forward, with reimbursement fully matured, where the predictive value of payment is pretty much assured, the recognition will be at the point of delivery of the test, from our lab to the referring physician. And we'll know based upon carriers, United and Aetna and what we're getting paid by those different entities and we'll develop the statistics by those entities to be able to record the revenue that we build them or submit the claim for and recognize it at that point of delivery.

因此，展望未來，隨著報銷完全成熟，支付的預測價值幾乎得到保證，認可將在測試交付時，從我們的實驗室到轉診醫生。我們將根據航空公司、美聯航和安泰保險以及我們從這些不同實體獲得的報酬了解情況，我們將開發這些實體的統計數據，以便能夠記錄我們為它們創造的收入或提交索賠，以及在交付時識別它。

Okay. Got it. And then just in terms of the lab operations, can you talk about the kind of gross margins at the current volumes? I mean I know you're not getting paid on all the tests, but let's say that you were getting paid on most of them or able to record the revenue, I guess I should say on most of them, what would that gross margin look like currently?

好的。知道了。然後就實驗室運營而言，您能談談當前產量的毛利率嗎？我的意思是，我知道您不會在所有測試中獲得報酬，但假設您在大多數測試中都獲得報酬或能夠記錄收入，我想我應該對大多數測試說，毛利率會是什麼樣子像現在這樣？

Our processing costs through the lab are about $125. That does not take into account the cost of the EsoCheck device. An EsoCheck device in full swing with a full transition to coastline is around $60. And the remaining balance of overhead, probably is $200 around it to the cost of revenue.

我們實驗室的處理成本約為 125 美元。這沒有考慮 EsoCheck 設備的成本。全面過渡到海岸線的全面啟動的 EsoCheck 設備售價約為 60 美元。剩餘的管理費用餘額大約為收入成本 200 美元。

We think that there's opportunity in the processing cost to bring them down as volume increases. Some of that will be through equipment efficiency and new equipment and higher volume efficiencies and some of it will just be the speed of which it moves through the facility as well as the cost of the lab supplies will go down.

我們認為，隨著產量的增加，加工成本有可能降低。其中一些將通過設備效率、新設備和更高的產量效率來實現，另一些將只是通過設施移動的速度以及實驗室用品的成本下降。

So there is some margin improvements, but generally thinking about it as a $200 per test. You have a $200 -- $2,000 billable tests, you're talking about a 90% margin. Obviously, it will take us some time to get there. That's probably how it plays itself out.

因此，利潤率有所提高，但通常認為每次測試 200 美元。您有 200 - 2,000 美元的計費測試，您所說的利潤率為 90%。顯然，我們需要一些時間才能到達那裡。這可能就是它自己的表現。

The next question comes from Mark Massaro with BTIG.

下一個問題來自 BTIG 的 Mark Massaro。

Congrats for another strong sequential volume quarter. We're in the summer here, and I just wanted to ask about potential impacts related to seasonality. Were there any large events in Q2 that occurred that you think may not occur again in Q3 that would put your sequential volume growth trajectory at risk?

祝賀季度銷量再次強勁。我們這裡正值夏天，我只是想詢問與季節性相關的潛在影響。您認為第二季度發生的任何重大事件在第三季度可能不會再次發生，從而使您的連續銷量增長軌跡面臨風險嗎？

Let me -- I'm glad you asked about that. Let's dive into that a little bit further. So the straight answer to your question is no, that as we sort of were hinting at earlier and we'll reiterate, the growth has been strong, both in the organic direct physician referral side as well as the testing event.

讓我——我很高興你問這個問題。讓我們進一步深入探討一下。因此，您的問題的直接答案是否定的，正如我們之前暗示的那樣，我們將重申，無論是在有機直接醫生轉診方面還是在測試活動方面，增長都很強勁。

And the testing of that volume is not just sort of individual event, testing event volume is -- some of them are smaller. Some of them are hundreds of patients. Some of them are dozens of patients. So it's just another channel, and it's another channel that where we have identical growth, and that compared to the other quarter-to-quarter, maybe not. But it's not like it's so bulky and choppy in one that we would expect it to mask sort of the sluggishness or slowing down on the other side.

該量的測試不僅僅是單個事件，測試事件量是——其中一些較小。其中一些是數百名患者。其中有的有數十名患者。所以這只是另一個渠道，這是另一個我們有相同增長的渠道，與其他季度相比，也許不是。但它並不像一側那麼笨重和不穩定，以至於我們期望它能夠掩蓋另一側的遲緩或放緩。

That said, I do want to -- so I'm glad you mentioned this because I wanted to mention a little bit more about the increase in productivity, right? So we have, as I mentioned, we did freeze our sales team, the overall team at 38, 39 sellers, and we've kept it there. And this growth has been driven by what we expected to happen, which is that with more tenure, we would have increased productivity.

也就是說，我確實想——所以我很高興你提到這一點，因為我想多提一點關於生產力的提高，對吧？因此，正如我所提到的，我們確實凍結了我們的銷售團隊，整個團隊由 38 名、39 名賣家組成，我們將其保留在那裡。這種增長是由我們預期發生的事情推動的，即隨著任期的延長，我們的生產力將會提高。

And productivity is about double this year in terms of the number of tests per seller per week. And we have a whole variety of initiatives and very sort of structure and data-driven processes that we expect to continue to extract more and more productivity per seller. That said that number is -- can't go up indefinitely. There are some level at which it will plateau, and we don't really know yet what that is.

就每個賣家每週的測試數量而言，今年的生產率大約翻了一番。我們有各種各樣的舉措以及非常種類的結構和數據驅動的流程，我們希望繼續為每個賣家提高越來越多的生產力。也就是說，這個數字不能無限期地上升。它會在某個水平上達到穩定水平，但我們還不知道那是什麼。

So given the encouraging news from -- on the revenue cycle management side, I think there's a good prospect that if we start seeing higher ASPs per test collections, that we might be in a position where we can say, "Well, we'll release that cap on the number of sellers and increase the number of sellers to accommodate potential plateauing of the productivity."

因此，鑑於收入周期管理方面的令人鼓舞的消息，我認為如果我們開始看到每個測試集合的平均售價更高，我們可能會說，“好吧，我們會放開賣家數量上限，增加賣家數量，以適應​​潛在的生產力停滯狀態。”

But if we don't increase the number of sellers, there will be some point at which will plateau and we won't necessarily be able to continue to drive this kind of quarter-on-quarter growth without increasing the number of sellers. So we won't do that until we have a little bit more traction on the payment side. Hopefully, that makes sense as a little bit of a comment there.

但如果我們不增加賣家數量，那麼到了某個時候就會達到穩定水平，如果不增加賣家數量，我們不一定能夠繼續推動這種季度環比增長。因此，除非我們在支付方面有更多的吸引力，否則我們不會這樣做。希望這作為一點評論是有意義的。

Yes. Yes. Yes, still early days. So yes, so my next question, now that the claims submission and adjudication pause has is over, and it sounds like you witnessed really strong trends in July, I'm curious if we could start to see the average realized prices trends back up almost to like the Q1 levels where you were in over $200 per test -- revenue per test or realized revenue per test? So I'm just trying to ask if you expect the sort of the billing and collections to manifest itself in terms of realizing price and seeing that flow into revenue in Q3?

是的。是的。是的，還為時尚早。所以是的，所以我的下一個問題，現在索賠提交和裁決暫停已經結束，聽起來你在 7 月份見證了非常強勁的趨勢，我很好奇我們是否可以開始看到平均實現價格趨勢幾乎回升想要喜歡每次測試超過200 美元的第一季度水平——每次測試的收入或每次測試的已實現收入？因此，我只是想問您是否期望這種計費和收款方式能夠在實現價格並看到第三季度收入流入方面體現出來？

Yes. We believe that to be true, particularly since we're seeing the number of claims that are being adjudicated out of -- that's why I gave some of those statistics. And the amount that -- of the adjudication that results in an allowed amount is almost 40%, and we expect that to continue to grow with Quadax's involvement. And that translates into collections, then I think that number not only gets to the first quarter but starts to exceed it on an accelerating basis quarter-by-quarter going forward.

是的。我們相信這是真的，特別是因為我們看到正在裁決的索賠數量——這就是我提供其中一些統計數據的原因。導致允許金額的裁決金額幾乎為 40%，我們預計隨著 Quadax 的參與，這一數字將繼續增長。這轉化為收藏，然後我認為這個數字不僅達到第一季度，而且開始逐季度加速超過它。

Excellent. Last one for me real quick. As I think about these clinical utility studies, I think in the past, you said you expect to complete them by the end of this calendar year. Is that still on track? And you provided an update on numbers, I think it's somewhere in the 200 range. How much -- how many more are you expecting to enroll? And how long will that enrollment go on for?

出色的。最後一張對我來說真的很快。當我思考這些臨床效用研究時，我認為您過去說過您希望在今年年底之前完成它們。那還在軌道上嗎？你提供了數字的更新，我認為它在 200 範圍內。您預計還有多少人報名？註冊會持續多久？

Yes, thanks for giving me the opportunity to clarify that. So clinically, some of these studies enroll on an ongoing basis that you get a certain number, and you can publish them. It's not like that it has a prespecified endpoints and things like that, like you would need (inaudible)?

是的，感謝您給我機會澄清這一點。因此，在臨床上，其中一些研究會持續招募，達到一定數量後就可以發表。它不像您需要的那樣有預先指定的端點之類的東西（聽不清）？

So what I should have been clear about is that the CLUE study has -- which has enrolled 206 patients will be -- is targeted to enroll up to 500 patients, and we expect to complete that enrollment by the end of the year. The Lucid Registry is open-ended. It will continue to enroll as long as we find it useful, both from a clinical utility point of view, but the Lucid Registry actually has the clinical validity component to it as well because we're actually diving further down into the patient's journey to get endoscopy data on those that are positive, so in terms of a whole variety of other purposes as well.

所以我應該明確的是，CLUE 研究已經招募了 206 名患者，目標是招募最多 500 名患者，我們預計在今年年底前完成招募。 Lucid 註冊表是開放式的。只要我們發現它有用，它就會繼續註冊，無論是從臨床效用的角度來看，但 Lucid 註冊實際上也有臨床有效性部分，因為我們實際上正在進一步深入了解患者的旅程，以獲取內窺鏡檢查數據呈陽性，因此也適用於各種其他目的。

What I was trying to and hopefully maybe want to clear about it is that our goal with regard to our first submission of a clinical utility study was to get to a total of 300 patients by the mid-summer exceeded at 500. So we are going to take the patients that we have enrolled to date and we're analyzing that data and expect to submit that as a stand-alone manuscript, one for CLUE, one for Registry, by the end of this month.

我想要澄清的是，我們第一次提交臨床效用研究的目標是，到仲夏時，患者總數將達到 300 名，超過 500 名。所以我們打算我們正在對迄今為止已入組的患者進行分析，並預計在本月底之前將其作為一份獨立的手稿提交，一份用於CLUE，一份用於登記。

But they'll both continue to enroll, and we'll look to submit additional data as we get larger numbers and tweak the analysis accordingly. Assume you've seen that in other companies as well with regard to just sort of multiple increasing volume of the amount of clinical utility, the amount of patients under that.

但他們都將繼續註冊，當我們獲得更多數據時，我們將尋求提交更多數據，並相應地調整分析。假設您在其他公司也看到了臨床效用數量、患者數量的成倍增加。

We wanted to get to this kind of 400 number because that's -- you need enough positives to demonstrate that a positive we'll get and endoscopy. And so we've definitely reached that number where that's going to be a meaningful data point.

我們想要達到這樣的 400 數字，因為你需要足夠的陽性結果來證明我們會得到內窺鏡檢查的陽性結果。所以我們肯定已經達到了這個數字，這將是一個有意義的數據點。

So basically, this is our first set of tools to engage payers on clinical utility, and we intend to do that. And we continue to evolve that with additional amounts and additional dimensions of clinical utility to engage them even further if there's any pushback at this first level of data.

所以基本上，這是我們第一套讓付款人參與臨床效用的工具，我們打算這樣做。我們繼續通過額外的數量和額外的臨床效用維度來發展這一點，以便在第一級數據出現任何阻力時進一步吸引他們。

Yes. More is better. We've learned that from monitoring other companies.

是的。越多越好。我們通過監測其他公司了解到這一點。

The next question comes from Ed Woo with Ascendiant Capital.

下一個問題來自 Ascendiant Capital 的 Ed Woo。

Congratulations on the quarter. My question is on the high-volume testing events. Have any of them been repeat or happened again and again? And do you have plans to make some of these events a regular basis at some of these locations?

祝賀本季度。我的問題是關於大容量測試活動。其中有沒有重複或一再發生過？您是否計劃在其中一些地點定期舉辦其中一些活動？

Great question, Ed. So yes, the answer is yes, that we've actually gone to had an event and there are people who couldn't make it. We've had events where retirees wanted to come and get tested, and we set a nurse practitioners back.

好問題，艾德。所以是的，答案是肯定的，我們實際上去參加了一個活動，但有些人無法參加。我們舉辦過一些活動，退休人員想要來接受檢查，但我們卻安排了一名執業護士回來。

So I wouldn't yet say that these are sort of recurring events where people will come back and get retested over some period of time. But they're not -- there have definitely been some repeat customers where the enthusiasm for an event and the positive feedback has led to us going back and just testing more people, extremely high patient satisfaction.

因此，我還不會說這些是重複發生的事件，人們會在一段時間內回來接受重新測試。但事實並非如此——肯定有一些回頭客，他們對活動的熱情和積極的反饋促使我們回去測試更多的人，患者滿意度極高。

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Aklog for any closing remarks.

我們的問答環節到此結束。我想將會議轉回給 Aklog 博士發表閉幕詞。

Great. So thank you all for your attention. I'd like to thank -- the questions were great, and we look forward to continuing to update you on our progress through press releases and follow-up calls. Feel free to contact us through Mike at mep@pavmed.com and to follow us on social media. Thank you very much, and have a great day.

偉大的。謝謝大家的關注。我要感謝——這些問題都很好，我們期待著繼續通過新聞稿和後續電話向您通報我們的最新進展。請隨時通過 Mike mep@pavmed.com 與我們聯繫，並在社交媒體上關注我們。非常感謝，祝您有美好的一天。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。