PAVmed Inc (PAVM) 2023 Q3 法說會逐字稿

Good day and welcome to the PAVmed third quarter 2023 business update conference call. (Operator Instructions) Please also note that today's event is being recorded.

美好的一天，歡迎參加 PAVmed 2023 年第三季業務更新電話會議。 （操作員說明）也請注意，今天的活動正在錄製中。

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

我現在想將會議交給投資者關係副總裁 Michael Parks。請繼續，邁克爾。

Thank you, operator. Good morning, everyone, and thank you for participating in today's third quarter 2023 business update call. The press release announcing our business update for the Company and financial results for the three and nine months ended September 30, 2023 is available on path on the PAVmed website. Please take a moment to read the disclaimer about forward-looking statements. The business update press release and the conference call both 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.

謝謝你，接線生。大家早安，感謝您參加今天的 2023 年第三季業務更新電話會議。宣佈本公司業務更新以及截至 2023 年 9 月 30 日的三個月和九個月財務業績的新聞稿可在 PAVmed 網站上取得。請花一點時間閱讀有關前瞻性陳述的免責聲明。業務更新新聞稿和電話會議均包含前瞻性聲明，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有重大差異。

Factors that could cause actual results to differ are described in the disclaimer and in our filings with the US Securities and Exchange Commission. For a list and description of these and other important risk factors or risk factors and uncertainties that may affect future operations, see Part I, Item 1A entitled Risk Factors in PAVmed's most recent annual report on Form 10-Q filed with the SEC and subsequent updates filed in the quarterly reports on Form 10-Q and any subsequent Form 8-K filings.

免責聲明和我們向美國證券交易委員會提交的文件中描述了可能導致實際結果不同的因素。有關這些和其他重要風險因素或可能影響未來營運的風險因素和不確定性的清單和描述，請參閱PAVmed 向SEC 提交的10-Q 表格最新年度報告及後續更新中標題為「風險因素」的第一部分第1A 項在季度報告中以 10-Q 表格和任何後續的 8-K 表格提交。

Except as required by law, PAVmed 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 those expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

除法律要求外，PAVmed 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，以反映預期或這些預期所依據的事件、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 PAVmed. Dr. Aklog?

現在我想將電話轉給 PAVmed 董事長兼執行長 Lishan Aklog 博士。阿克洛格博士？

Thanks, Mike, and thanks, everyone, for joining us this morning. We look forward to providing you with this update on PAVmed's business and finances.

謝謝麥克，也謝謝大家今天早上加入我們。我們期待為您提供有關 PAVmed 業務和財務的最新資訊。

First, a quick reminder that we held a separate business update call for PAVmed subsidiary, Lucid Diagnostics yesterday. Today I will limit my comments on Lucid's business to key highlights. I would encourage you to view the recording of yesterday's call, which is available on the Lucid website for further details from Lucid's business update.

首先，快速提醒一下，我們昨天為 PAVmed 子公司 Lucid Diagnostics 舉行了單獨的業務更新電話會議。今天我將對 Lucid 業務的評論僅限於關鍵亮點。我建議您查看昨天的通話錄音，該錄音可在 Lucid 網站上獲取，以了解 Lucid 業務更新的更多詳細資訊。

First, some quick background PAVmed is a commercial stage medical technology company with two subsidiaries, which are marketing commercial products, privately held various health and NASDAQ-listed Lucid Diagnostics.

首先，簡單介紹一下背景 PAVmed 是一家商業階段的醫療技術公司，擁有兩家子公司，分別銷售商業產品、私人持有的各種健康產品和納斯達克上市的 Lucid Diagnostics。

As the parent company patented provides a shared services infrastructure, including management services to each subsidiary. The model drives substantial economies of scale and infrastructure which facilitates licensing or acquisition of high-value assets such as Lucid and Veris. We implemented a strategic restructuring in early 2023 to focus substantially all of our resources and efforts on our two commercial enterprises, Lucid and Veris. And this update will reflect that strategy.

由於母公司獲得專利，因此提供了共享服務基礎設施，包括向每個子公司提供管理服務。該模式推動了巨大的規模經濟和基礎設施，從而促進了 Lucid 和 Veris 等高價值資產的許可或收購。我們在 2023 年初實施了策略重組，將所有資源和精力主要集中在我們的兩家商業企業 Lucid 和 Veris 上。此次更新將反映此策略。

That said, I'll briefly note that we have one active internal R&D project in partnership with Novosound and to develop a next-generation intravascular, ultrasound device. That progress is progressing very well, having completed two or three milestones. I will also note, as I have in recent calls, we remain very active on the business development side since current market conditions offer a plethora of high-value assets, which may provide real opportunities to enhance PAVmed shareholder value.

也就是說，我要簡要地指出，我們與 Novosound 合作進行了一個活躍的內部研發項目，旨在開發下一代血管內超音波設備。這項進展進展順利，已經完成了兩三個里程碑。我還要指出，正如我在最近的電話會議中所做的那樣，我們在業務發展方面仍然非常活躍，因為當前的市場狀況提供了大量的高價值資產，這可能為提高PAVmed 股東價值提供真正的機會。

Let me start with some highlights for various Lucid before proceeding to a deeper dive on Veris updates. Veris health is undergoing a commercial restructuring and expansion that is currently underway under the leadership of our President, Gary Manning, who started several months ago. We have active strategic discussions with large academic medical centers and we feel there's great promise there.

讓我先介紹一下各種 Lucid 的亮點，然後再深入探討 Veris 更新。 Veris health 正在進行商業重組和擴張，目前正在幾個月前開始的總裁 Gary Manning 的領導下進行。我們與大型學術醫療中心進行了積極的策略討論，我們認為那裡有很大的前景。

Our next-generation Veris Cancer Care Platform is scheduled to launch this quarter, and we have active discussions with large biopharma companies on the cancer care platforms, biopharma module to serve as a digital companion for novel cancer therapeutics.

我們的下一代 Veris 癌症護理平台計劃於本季度推出，我們與大型生物製藥公司就癌症護理平台、生物製藥模組進行積極討論，以作為新型癌症治療的數位伴侶。

Finally, the implantable model -- monitor, excuse me, is progressing towards FDA submission and commercial launch in 2024. As I mentioned yesterday, Q3 has been the most important quarter in Lucid's histories as we've crossed several critical milestones in translating steady test volume growth into revenue and revenue growth. Briefly, quarterly EsoGuard test volume grew 17% and quarterly revenue growth increased 376%. Our revenue cycle management upgrade has demonstrated solid progress in the first full quarter reporting.

最後，植入式模型- 監視器，正在向FDA 提交申請並於2024 年商業推出。正如我昨天提到的，第三季度是Lucid 歷史上最重要的季度，因為我們在轉化穩定測試方面已經跨越了幾個關鍵里程碑銷售成長轉化為收入成長。簡而言之，季度 EsoGuard 測試量成長了 17%，季度營收成長了 376%。我們的收入週期管理升級在第一個完整季度報告中展示了堅實的進展。

Clinical utility studies with near-perfect results have been -- have had their results released, and two of them have been accepted for peer-review publication, one is pending. Our direct contracting initiative has netted its first employer contract and our new VP of employer markets is pursuing -- offering EsoGuard as a benefit to employers. And finally, as we announced this week, EsoGuard 2.0 is launched with potential, with clear benefits in performance as well as in the per sample assay costs.

結果近乎完美的臨床效用研究已經發布，其中兩項已接受同行評審出版，一項正在等待中。我們的直接簽約計劃已經獲得了第一份雇主合同，我們新任雇主市場副總裁正在追求——為雇主提供 EsoGuard 作為一項福利。最後，正如我們本周宣布的那樣，EsoGuard 2.0 的推出具有潛力，在性能和每個樣本分析成本方面具有明顯的優勢。

Let's now proceed to a deeper update on Veris.

現在讓我們對 Veris 進行更深入的更新。

Next slide. Veris Health is a commercial-stage digital health company that seeks to enhance personalized cancer care. We have two features, one is the Veris Cancer Care Platform, which has a patient module that operates from a smartphone and is able to transmit physiologic parameters from connected devices as part of our VerisBox. It also includes a clinician portal where that data is presented to clinicians and provides a variety of opportunities for the cancer care team to interface with the patient and enhance their care. We also have an implantable monitor that's in the works, that is designed to be implanted at the same time, has a chemotherapy or immunotherapy port. Veris's mission is to utilize modern remote patient monitoring tools to improve care through early detection of complications, longitudinal trends, and risk management.

下一張投影片。 Veris Health 是一家商業階段的數位健康公司，致力於增強個人化癌症護理。我們有兩個功能，一是 Veris 癌症護理平台，它有一個透過智慧型手機操作的患者模組，能夠從連接的設備傳輸生理參數，作為我們 VerisBox 的一部分。它還包括一個臨床醫生入口網站，將數據呈現給臨床醫生，並為癌症護理團隊提供各種機會與患者互動並加強他們的護理。我們還有一款正在開發中的植入式監測儀，設計為同時植入，並具有化療或免疫治療端口。 Veris 的使命是利用現代遠端患者監測工具，透過早期發現併發症、縱向趨勢和風險管理來改善護理。

Next slide. The opportunity to improve patient outcomes, increase workflow efficiency, and lower costs results in a substantial market opportunity. There are millions of hospitalizations for cancer per year, and about two-thirds of them are unplanned admissions with substantial cost to the hospital. And 20% of these unplanned admissions are likely preventable. This results in a total addressable market opportunity of approximately $2 billion.

下一張投影片。改善病患治療效果、提高工作流程效率和降低成本的機會帶來了巨大的市場機會。每年有數百萬人因癌症住院，其中約三分之二是計劃外入院，為醫院帶來了巨額費用。其中 20% 的非計劃性住院可能是可以避免的。這導致總的潛在市場機會約為 20 億美元。

The business model is very attractive, it's a software as a service recurring revenue model that leverages established remote patient monitoring codes. It also provides Veris with additional revenue opportunities through enhanced technical support and charging for clinical integration, clinical support such as our in coverage, as well as revenue opportunities directly derived from the implantable device. It allows the clinical cancer care practice to leverage value-based models, such as the EOM or Enhancing Oncology Model that CMS provides.

這種商業模式非常有吸引力，它是一種軟體即服務的經常性收入模式，利用已建立的遠端患者監控程式碼。它還透過增強技術支援和臨床整合收費、臨床支援（例如我們的覆蓋範圍）以及直接來自植入設備的收入機會，為 Veris 提供額外的收入機會。它允許臨床癌症護理實踐利用基於價值的模型，例如 CMS 提供的 EOM 或增強腫瘤學模型。

Next slide. A few updates on our commercial execution. We remain focused on several early adopters, which are small to medium oncology practice, and we spent the last several months focused on really ironing out the customer integration and customer support, engaging with patients, making sure that patients are able to report their data to streamline, to make that process as streamlined and efficient as possible for the practice operations and billing.

下一張投影片。關於我們商業執行的一些更新。我們仍然專注於幾個早期採用者，這些是中小型腫瘤學實踐，我們在過去的幾個月裡專注於真正解決客戶整合和客戶支持，與患者互動，確保患者能夠向他們報告他們的數據精簡，使實務操作和計費的流程盡可能精簡和有效率。

Many of the, much of the feedback that we've received from these early adopters and early engagements have been incorporated into our next generation 2.0 version of the Veris Cancer Care platform, which is completing its development and is expected to launch this quarter.

我們從這些早期採用者和早期參與中收到的許多回饋已納入我們的下一代 2.0 版本的 Veris Cancer Care 平台中，該平台正在完成開發，預計將於本季度推出。

As I mentioned earlier, we've undergone a significant restructuring and expansion of our commercial team under Gary Manning's leadership since he took over several months ago. We recently hired two new market development managers with experience in this area that are now started and are actively calling on cancer care practices across the country to expand the number of accounts that we have under our belt, now that we have the next generation product that incorporates the feedback from our early adopters.

正如我之前提到的，自從幾個月前加里·曼寧上任以來，我們在加里·曼寧的領導下對我們的商業團隊進行了重大重組和擴張。我們最近聘請了兩名在該領域具有經驗的新市場開發經理，他們現在已經開始積極呼籲全國範圍內的癌症護理實踐，以擴大我們擁有的客戶數量，因為我們擁有下一代產品納入了我們早期採用者的回饋。

We are, as I mentioned, in active strategic discussions with large academic cancer centers, the pathway for engaging with them is rather different and as always the case has longer lead times. And we're very excited about a couple of leads here which we hope to consummate into active accounts in the near term.

正如我所提到的，我們正在與大型學術癌症中心進行積極的策略討論，與他們合作的途徑相當不同，而且一如既往，交付時間較長。我們對這裡的一些線索感到非常興奮，我們希望在短期內將其完善為活躍帳戶。

Next slide. As we introduced in our last call, there's a separate opportunity, the Bio Pharma opportunity that we're very excited about and we are aggressively pursuing. The goal here is for the Veris platform to act as a companion solution for post-market surveillance of novel oncology drugs. The numbers are quite impressive. It costs about $40 million per study to execute a Phase IV post-marketing surveillance clinical study for oncology therapeutics and essentially all clear drugs are required to undergo that. And every day on the market costs about $2.7 million for a $1 billion blockbuster drug.

下一張投影片。正如我們在上次電話會議中所介紹的那樣，有一個單獨的機會，即生物製藥機會，我們對此感到非常興奮，並且正在積極追求。 Veris 平台的目標是充當新型腫瘤藥物上市後監測的配套解決方案。這些數字相當可觀。執行腫瘤治療的 IV 期上市後監測臨床研究，每項研究的成本約為 4000 萬美元，基本上所有明確的藥物都需要接受研究。價值 10 億美元的重磅藥物每天的市場售價約為 270 萬美元。

The goal here is to use the platform to create value for both the biopharma companies and the oncology practice through certified clinics to administer new therapies. It allows drugs to move up the chain of therapy. So for example, if it's initially cleared as a third or fourth line drug to move as a second and first line drug with dramatic economic impact to the company and to increase patient adherence to care pathways that are very well defined during the post-market surveillance period.

這裡的目標是利用該平台透過認證診所管理新療法，為生物製藥公司和腫瘤學實踐創造價值。它允許藥物在治療鏈中向上移動。例如，如果它最初被批准為三線或四線藥物，那麼將成為二線和一線藥物，對公司產生巨大的經濟影響，並提高患者對上市後監測期間明確定義的護理途徑的依從性時期。

So we have active discussions with several large pharma companies to see if we can engage them to have the Veris Health platform and the bio-pharma module serve in this role. So we previously have talked about the full spectrum of opportunities, both in the drug development phase, around the time of FDA submission. But our initial focus right now, where we believe the greatest opportunity for near-term commercial impact is in the post-FDA approval phase, where during this market surveillance and that can include existing drugs that are working their way up the chain of therapy, as I previously explained.

所以我們和幾家大型製藥公司積極討論，看看是否可以讓他們讓 Veris Health 平台和生物製藥模組來扮演這個角色。因此，我們之前討論過在藥物開發階段和向 FDA 提交申請期間的全方位機會。但我們現在最初的重點是，我們認為近期商業影響的最大機會是在 FDA 批准後階段，在市場監督期間，這可能包括正在沿著治療鏈進行的現有藥物，正如我之前所解釋的。

Next slide. As we have previously announced, we are also transitioning the Veris platforms from its current status within the regulatory framework as an MDDS or medical device data system, which is only displaying medical data for clinicians without modification into an SaMD, which is a software as a medical device, which under FDA regulations is intended for use in diagnosing or treating patients. The upgrades of this platform to an FDA is cleared.

下一張投影片。正如我們先前宣布的，我們也將 Veris 平台從目前在監管框架內作為 MDDS 或醫療設備數據系統的狀態（僅向臨床醫生顯示未經修改的醫療數據）轉變為 SaMD（作為一種軟體）根據FDA規定，醫療設備旨在用於診斷或治療患者。該平台向 FDA 的升級已獲批准。

SaMD will provide us with really unlimited potential to grow into a full-fledged clinical decision support tool, so beyond just simply being a remote patient monitoring tool that transmits information, we'll be able to provide patient threshold alarms, alerts, notifications, triage, and even something called digital biomarkers that are based on AI and machine learning models for patient risk profiling. So that process is progressing for an FDA 510(k) submission as a software as a medical device in 2024.

SaMD 將為我們提供真正無限的潛力，發展成為成熟的臨床決策支援工具，因此不僅僅是簡單地作為傳輸資訊的遠端患者監測工具，我們將能夠提供患者閾值警報、警報、通知、分類，甚至是基於人工智慧和機器學習模型的數位生物標記物，用於患者風險分析。因此，該流程正在取得進展，預計將於 2024 年作為醫療設備軟體向 FDA 510(k) 提交。

Next slide. And finally, as I mentioned, we're very excited to be making solid progress on the Veris implantable monitor. This monitor, as you can see on the right there, is designed to have physiologic monitor, that's the silver structure there, that is implanted, which can be implanted in conjunction with an implantable vascular access port, which approximately 50% of cancer patients receive to have their chemotherapy or immunotherapy delivered.

下一張投影片。最後，正如我所提到的，我們非常高興能夠在 Veris 植入式監視器方面取得紮實進展。正如您在右側看到的那樣，該監測器被設計為具有生理監測器，即植入的銀結構，可以與可植入血管接入端口一起植入，大約50% 的癌症患者接受植入式血管接入端口。接受化療或免疫治療。

The key features will be continuous cardiac monitoring activity, it will have a patient-triggered event monitor, temperature, respiratory rate, and bluetooth connectivity that will supplement the existing external connected devices. We have had multiple successful FDA pre-submission meetings, seeking feedback on all these various design features, and those have all gone extremely well, and we're progressing towards FDA submission and commercial launch next year. Once we have this in place, it will really be a game changer for the platform as it assures 100% patient compliance with the remote patient monitoring billing requirements and really provides a substantial added value both on the clinical care side as well as the economics for the medical, for the practice and the institution.

主要功能是連續心臟監測活動，它將具有患者觸發的事件監測器、溫度、呼吸頻率和藍牙連接，以補充現有的外部連接設備。我們已經成功召開了多次 FDA 提交前會議，尋求有關所有這些不同設計功能的反饋，這些都進展得非常順利，我們正在向明年 FDA 提交和商業推出邁進。一旦我們實現了這一點，它將真正改變該平台的遊戲規則，因為它可以確保患者 100% 遵守遠端患者監測計費要求，並真正在臨床護理方面以及經濟方面提供可觀的附加價值。醫療、實踐和機構。

Next slide. So as I stated, I'll keep the overview of Lucid's business to some highlights from the third quarter. These were again covered in substantially greater detail on yesterday's Lucid call. On the commercial execution side, we performed 2,575 tests -- EsoGuard tests, which is a 17% quarter-on-quarter growth and 137% annual growth. Revenue was $784,000 tests -- sorry, revenue $784,000, which is nearly 400% quarterly growth and nearly double on an annual basis.

下一張投影片。正如我所說，我將保留第三季的一些亮點來概述 Lucid 的業務。昨天的 Lucid 電話會議再次詳細討論了這些問題。在商業執行方面，我們進行了 2,575 次測試——EsoGuard 測試，季增 17%，年增 137%。測試收入為 784,000 美元——抱歉，收入為 784,000 美元，季度增長近 400%，年度增長近一倍。

We have strong contributions from our satellite Lucid test centers and our high volume check your food tube testing events, and we're gaining traction with several important strategic accounts. Other strategic accomplishments are that we recently upgraded our revenue cycle management infrastructure and processes as we announced in the last quarter, and the early results of that have continued and are delivering really solid results with EsoGuard claims processing and payments. We've had a very substantial boost to our clinical utility data to support in-network payer coverage engagement.

我們的衛星 Lucid 測試中心和我們的大量檢查您的食品管測試活動為我們做出了巨大貢獻，並且我們正在獲得幾個重要戰略客戶的關注。其他策略成就是，正如我們在上個季度宣布的那樣，我們最近升級了我們的收入週期管理基礎設施和流程，並且早期結果仍在繼續，並透過 EsoGuard 索賠處理和付款提供了真正可靠的結果。我們的臨床公用事業數據得到了極大的提升，以支持網路內付款人承保參與。

We have over 1,500 patients across three studies that have been released, the CLUE study, PREVENT Registries, and San Antonio Firefighter Department study. Two of these have been accepted for peer review publication and one is pending. We're accelerating activity and direct contracting with employers to offer the EsoGuard as a benefit. Our first contract is signed. Testing has begun and our new VP of Employment Markets is hired and will be starting this week. As we announced this week, our EsoGuard 2.0 assay has been launched in our laboratory in Orange County, California, with improved performance and lower costs.

我們已發布的三項研究（CLUE 研究、PREVENT Registries 和聖安東尼奧消防部門研究）涉及 1,500 多名患者。其中兩項已被接受進行同儕審查出版，另一項正在等待中。我們正在加速活動並與雇主直接簽訂合同，以提供 EsoGuard 作為福利。我們的第一份合約已經簽訂。測試已經開始，我們新任就業市場副總裁已受聘，將於本週上任。正如我們本周宣布的，我們的 EsoGuard 2.0 檢測已在加州橘郡的實驗室推出，其性能得到了提高，成本也降低了。

Next slide. I'll just point out the steady test volume growth, which represents eight consecutive quarters or two full years of quarter-on-quarter growth to 2,575 and represents � and indicate, as shown here, that we still have substantial laboratory manufacturing capacity, which is currently over 10,000 tests per quarter.

下一張投影片。我只想指出測試量的穩定增長，這代表連續八個季度或整整兩年的季度環比增長，達到 2,575 個，並表明，如此處所示，我們仍然擁有大量的實驗室製造能力，目前每季進行超過10,000 次測試。

Next slide. With that, I'll hand the [rest] over to Dennis who will proceed with our financial update.

下一張投影片。這樣，我將把[其餘的]交給丹尼斯，他將繼續我們的財務更新。

Thank you, Lishan. Good morning, everyone. Our summary financial results for the third quarter were reported in our press release that was published last night. On the next three slides, I'll emphasize a few key highlights from the quarter. I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q that was filed with the SEC -- previously filed with the SEC and is available on our PAVmed website.

謝謝你，李山。大家，早安。我們昨晚發布的新聞稿中報告了第三季的財務業績摘要。在接下來的三張幻燈片中，我將強調本季的一些關鍵亮點。我鼓勵您在我們向 SEC 提交的 10-Q 表格季度報告中所涵蓋的完整披露內容中考慮這些言論——之前已向 SEC 提交並可在我們的 PAVmed 網站上獲取。

Slide 16. Our balance sheet demonstrates cash of $26.4 million, and it reflects a sequential burn rate of $10.7 million. We have successfully cut our burn rate in each of the first three quarters of this year, reflecting quarterly burn rate reduction of more than $6 million since the fourth quarter of last year for an average reduction of $2 million in each successive quarter.

投影片 16。我們的資產負債表顯示現金為 2,640 萬美元，反映了 1,070 萬美元的連續消耗率。今年前三個季度，我們每季都成功降低了燒錢率，自去年第四季以來，季度燒錢率減少了超過 600 萬美元，連續每季平均減少了 200 萬美元。

These improvements are related to the cost control initiatives we put in place at the beginning of the year with continued improvement in each successive quarter. Obviously, the cash balance does not reflect the $5 million in additional Lucid funding shortly after the end of the quarter, nor the remaining $10 million draw available to us under the Securities Purchase Agreement signed in March of 2022, nor other resources that are available to us at the PAVmed and Lucid entity levels.

這些改進與我們在年初實施的成本控制措施有關，並在連續每季持續改善。顯然，現金餘額並沒有反映本季度結束後不久追加的500 萬美元Lucid 資金，也沒有反映我們根據2022 年3 月簽署的證券購買協議可以提取的剩餘1000 萬美元，也沒有反映我們可以使用的其他資源。我們在 PAVmed 和 Lucid 實體層面。

On a pro-forma basis, including the remainder of the securities purchase agreement, and assuming the net burden rate is sustained at this level, our runway is about a year. Furthermore, as cash collections continue to accelerate, as we will talk about in a second, This can further throttle the burn rate for the upcoming quarters.

根據預計，包括證券購買協議的其餘部分，並假設淨負擔率維持在這個水平，我們的跑道大約是一年。此外，隨著現金回收繼續加速，正如我們稍後將討論的那樣，這可能會進一步抑制未來幾季的資金消耗率。

Vendor payables. They can vary by quarter based upon the timing of receipt of vendor invoices. Although accounts payable is up sequentially, the balance sheet and the 10-Q reflects a decrease from the beginning of the year. Other current liabilities of $1.6 million increase. The largest increase is the accrual for certain insurance renewals that get paid over the next year and has an offsetting amount in the current assets as prepaid amounts.

供應商應付款項。根據收到供應商發票的時間，它們可能會因季度而異。儘管應付帳款環比成長，但資產負債表和 10 季度業績較年初下降。其他流動負債增加 160 萬美元。最大的增幅是某些保險續保的應計費用，這些保險續保將在明年支付，並在流動資產中作為預付金額進行抵銷。

Convertible debt. A net sequential increase of $2 million largely related to an increase in the non-cash charge in fair value adjustments, which increases our offset by debt repayments via conversions to common stock during the quarter. Other long-term liabilities are from capitalized leases related to our lab and office spaces. Shares outstanding include unvested restricted stock awards as of today, equals 120.8 million shares. The GAAP outstanding shares of 119.7 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q.

可轉換債務。環比淨增長 200 萬美元，很大程度上與公允價值調整中非現金費用的增加有關，這增加了我們在本季度透過轉換為普通股償還債務的抵銷額。其他長期負債來自與我們的實驗室和辦公空間相關的資本化租賃。已發行股票包括截至今日尚未歸屬的限制性股票獎勵，相當於 1.208 億股。 1.197 億股的 GAAP 流通股反映在投影片以及 10 季資產負債表的表面。

So, Slide 17. Slide 17 compares this year's third quarter to last year's third quarter, and similarly for the nine-month totals on certain key items. I trust you'll review the information and my comments in light of the cautionary disclosure on the bottom of the slide about supplemental information, particularly non-GAAP information.

因此，投影片 17。投影片 17 將今年第三季與去年第三季進行了比較，並對某些關鍵項目的九個月總計進行了類似的比較。我相信您會根據幻燈片底部有關補充資訊（特別是非公認會計原則資訊）的警告性披露來查看這些資訊和我的評論。

Revenue for the third quarter largely reflects Lucid actual cash collections for the quarter for insurance reimbursement claims, plus invoiced EsoGuard to the Veterans Administration, plus invoiced amounts for the Veris Cancer Care Platform. As detailed in our Lucid quarterly call yesterday, we highlighted the discussion that began on our first quarter call in May, regarding the major change and upgrade we made to the Lucid's Revenue Cycle Management Company. Recognized Lucid revenue of $783,000 substantially reflects cash collections in the quarter versus the pro forma revenue of about $5 million for the submitted claims of nearly 2,600 tests.

第三季的收入主要反映了 Lucid 本季保險報銷索賠的實際現金收款，加上向退伍軍人管理局開立的 EsoGuard 發票，以及 Veris 癌症護理平台的發票金額。正如昨天 Lucid 季度電話會議中詳細介紹的那樣，我們重點介紹了 5 月份第一季電話會議中開始的討論，內容涉及我們對 Lucid 收入周期管理公司所做的重大變更和升級。 Lucid 確認收入為 783,000 美元，很大程度上反映了本季的現金收款，而針對近 2,600 項測試提交的索賠，預計收入約為 500 萬美元。

As mentioned in the Lucid call yesterday, fourth quarter collections so far are trending 33% higher. The third quarter Veris revenue reflects the initial patients equivalent to about 98 patient months, put on the platform for each of the first two onboarded cancer care centers during initial customer acceptance processes that included validation, customization, and integration with the respective EHR systems. Generally a heavily controlled and very intense pressure testing of the platform as it relates to clinicians relying upon the Veris platform information and the speed of connecting patients and clinicians and the ability to effectively communicate with an update the client's electronic health records and other patient care related systems. Both clients are reporting they are quickly cash flow positive on the platform.

正如昨天 Lucid 電話會議中提到的，迄今為止第四季度的產品系列趨勢增長了 33%。第三季 Veris 收入反映了相當於約 98 個患者月的初始患者數量，這些患者在初始客戶接受過程中放入平台，包括驗證、客製化以及與各自的 EHR 系統整合。通常對平台進行嚴格控制和非常嚴格的壓力測試，因為它與依賴 Veris 平台資訊的臨床醫生以及連接患者和臨床醫生的速度以及有效溝通更新客戶的電子健康記錄和其他患者護理相關的能力有關係統。兩家客戶均表示，他們在該平台上的現金流很快就轉為正值。

Lucid 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 means revenue recognition occurs when the claim is actually collected versus when the patient report is invoiced and submitted for 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.

清晰的收入確認。一個關鍵的決定因素是收集的機率。因此，由於我們處於報銷流程的早期階段，這意味著實際收取索賠時與患者報告開立發票並提交報銷時才會確認收入。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」。

And presently, there is insufficient predictive data to recognize revenue when invoiced. As for the Veris revenue, we expect to continue to recognize revenue on an as-incurred and as-invoiced basis subject to normal GAAP rules.

目前，沒有足夠的預測數據來在開立發票時確認收入。至於 Veris 收入，我們預計將繼續按照正常 GAAP 規則在已發生和已開立發票的基礎上確認收入。

Some comments on GAAP and non-GAAP OpEx, as well as net loss. The presentation shows year-over-year comparisons, but I will also go through sequential changes, which are more indicative of where we are heading in the upcoming quarters. Our third quarter sequential OpEx on both a GAAP and non-GAAP basis are not only flat, but within a few dollars of each other. The year-over-year OpEx comparison shows an improvement in OpEx by about 30% for each of the GAAP and non-GAAP measures, a direct reflection of the cost controls we put in place the beginning of the year. Our third quarter non-GAAP loss per share is $0.09, a decrease of a $0.01 from the second quarter and an $0.08 improvement from the loss of $0.17 in the prior year third quarter.

關於 GAAP 和非 GAAP 營運支出以及淨虧損的一些評論。該簡報顯示了同比比較，但我還將逐一介紹連續的變化，這更能表明我們在未來幾季的發展方向。我們在第三季以 GAAP 和非 GAAP 計算的連續營運支出不僅持平，而且相差不到幾美元。營運支出與去年同期相比顯示，按照 GAAP 和非 GAAP 衡量標準，營運支出均提高了約 30%，這直接反映了我們年初實施的成本控制。我們第三季的非 GAAP 每股虧損為 0.09 美元，比第二季減少 0.01 美元，比去年第三季的虧損 0.17 美元減少 0.08 美元。

On a GAAP EPS basis, non-cash charges accounted for approximately $0.7 per share in the quarter, including approximately $0.5 per share related to the expenses from the convertible debt. If you were to normalize the loss by adding back the effect of the net convertible debt expenses, the GAAP EPS improved by $0.2 year-over-year for the quarter and improved $0.27 year-over-year for the year to date.

根據 GAAP 每股收益計算，本季非現金費用約為每股 0.7 美元，其中包括與可轉換債務費用相關的每股約 0.5 美元。如果您透過加回淨可轉換債務費用的影響來使損失正常化，那麼本季的 GAAP 每股收益將同比提高 0.2 美元，而今年迄今為止則同比提高 0.27 美元。

Slide 18. Slide 18 is a graphic illustration of our operating expenses as presented in detail in our press release. Other than the comments already pointed out on OpEx about the relatively flat sequential amounts and the reductions year-over-year, there is nothing really remarkable in the sequential piece parts of OpEx with only relatively minor pluses and minuses between the components of OpEx.

投影片 18。投影片 18 是我們的營運費用的圖解說明，如我們的新聞稿中詳細介紹的。除了已經在營運支出上指出的關於相對平穩的連續金額和同比減少的評論之外，營運支出的連續部分沒有什麼真正值得注意的，營運支出的組成部分之間只有相對較小的優點和缺點。

It is noteworthy to point out, as I did yesterday on the Lucid call, that the pro forma marginal cost of revenue validates the model of nearly 90% Lucid margins for the next patient test walking in the door. As a reminder, the cost of revenue primarily consists of Lucid lab supplies, fixed lab facility costs, with a much smaller amount attributable to the delivery costs for the Veris Health Cancer Care platform.

值得注意的是，正如我昨天在 Lucid 電話會議上所做的那樣，預計邊際收入成本驗證了下一次患者測試中近 90% Lucid 利潤率的模型。提醒一下，收入成本主要包括 Lucid 實驗室用品、固定實驗室設施成本，其中一小部分歸因於 Veris Health 癌症護理平台的交付成本。

Also noteworthy, also worthy of repeating, some reimbursement stats as mentioned on the Lucid call yesterday. Since the new revenue cycle manager to Quadax took over in mid-June, 5,000 claims representing approximately $10 million in pro-forma revenue have been submitted for reimbursement. About 70% have been adjudicated, 30% are pending. Out of the 70% that have been adjudicated, about 39% resulted in an allowable amount by the insurance company with a mean average of $1,863 per test, nearly the Medicare rate. Of those denied, about 58% require either additional information or deemed not medically necessary or require a prior authorization. About 36% were deemed to be non-covered.

同樣值得注意、也值得重複的是昨天 Lucid 電話會議中提到的一些報銷統計數據。自 Quadax 新收入週期經理於 6 月中旬上任以來，已提交了 5,000 份索賠申請，代表預計收入約 1,000 萬美元。大約 70% 已裁決，30% 待決。在已裁定的 70% 中，約 39% 的結果是保險公司允許的金額，平均每次測試為 1,863 美元，接近 Medicare 費率。在被拒絕的人中，約 58% 需要額外資訊或被認為沒有醫療必要性或需要事先授權。大約 36% 被認為沒有覆蓋。

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)

（操作員說明）

Frank Takkinen, Lake Street.

弗蘭克·塔基寧，湖街。

Good morning, Frank.

早安，弗蘭克。

Hi, Frank.

嗨，弗蘭克。

Frank, your line is open. Please check if you're muted.

弗蘭克，您的線路已開通。請檢查您是否處於靜音狀態。

Good morning. Can you guys hear me now?

早安.你們現在聽得到我說話嗎？

Yeah, yes, we can.

是的，是的，我們可以。

I apologize. Maybe just to start on the commercial side on Veris, you mentioned a couple comments. Obviously, there's new leadership there, a couple new market development managers. Maybe dive a little deeper into what we should expect for commercial investments related to Veris over the next couple of years or quarters?

我道歉。也許只是從 Veris 的商業方面開始，您提到了一些評論。顯然，那裡有新的領導階層，幾個新的市場開發經理。也許更深入地探討一下我們對未來幾年或幾季與 Veris 相關的商業投資的預期？

Sure. Yeah, I think the last couple of quarters have been really focused on the model and the template and the processes and logistics around getting a practice up and running. There are some significant logistics involved with the processes of getting patients on the platform, getting them their boxes, getting them their devices, making sure they're connected, as well as getting the practice on the clinician portal, getting that integrated with the EHR and so forth.

當然。是的，我認為過去幾個季度的重點是模型、模板以及圍繞實踐啟動和運行的流程和物流。在讓患者進入平台、為他們提供盒子、為他們提供設備、確保他們已連接、以及在臨床醫生門戶網站上獲取實踐、將其與 EHR 集成的過程中，涉及到一些重要的後勤工作。等等。

So, a lot of those kinks have now been worked out, and we've had, as I mentioned, good feedback from the two practices were really, heavily engaged in this and helping us with working out all those kinks. And ultimately, what we wanted to do before pushing harder to expand the number of counts is to make sure that not only does do things does the integration aspects to this operate smoothly. But we can confirm that the practice is actually able to build that, we're facilitating that process through the platform by providing the time stamp, time calculation measures and so forth that allow them to build under these various codes and that they're actually getting paid.

因此，現在很多問題都已經解決，正如我所提到的，我們從這兩個實踐中得到了良好的回饋，我們確實非常積極地參與其中，並幫助我們解決了所有這些問題。最終，在更努力地擴大計數數量之前，我們想要做的是確保不僅能做到這一點，而且整合方面也能順利運作。但我們可以確認，這種做法實際上能夠構建這一點，我們透過平台提供時間戳、時間計算措施等來促進該過程，從而允許它們在這些不同的程式碼下構建，並且它們實際上是獲取報酬。

And so, we've really made a ton of progress on that, as Dennis mentioned, the practices are telling us that we are now -- that they are now cash flow positive and they're getting paid. And so we have two opportunities here, one is to drive patient enrollment and patients on the platform at our -- at existing sites and put in measures to try to achieve high percentages of the cancer patients in the practice being on our platform. And there's a lot of opportunity to simply drive that within each account.

因此，正如丹尼斯所提到的，我們在這方面確實取得了很大進展，這些做法告訴我們，我們現在——他們現在現金流為正，並且正在獲得報酬。因此，我們在這裡有兩個機會，一是在我們的現有站點上推動患者註冊和平台上的患者，並採取措施，努力在我們的平台上實現高比例的癌症患者實踐。並且有很多機會可以在每個帳戶中簡單地推動這一點。

And then, of course, as I mentioned, we just hired two very experienced market development managers who are going to take our experience and the story around the streamlined processes and the opportunity to quickly get to cash flow positive to new accounts. So that's we're gonna go, and they started -- within the last month, they've completed their orientations, and they are now out of the field chasing down leads and opportunities for us to add accounts across the country.

當然，正如我所提到的，我們剛剛聘請了兩位經驗豐富的市場開發經理，他們將利用我們的經驗和簡化流程的故事以及快速為新客戶帶來正現金流的機會。這就是我們要去的地方，他們開始了——在上個月內，他們已經完成了他們的入職培訓，他們現在正在外面尋找線索和機會，讓我們在全國範圍內增加帳戶。

So it's really a two-pronged approach, expanding accounts, but as importantly, making sure that when we're on accounts that -- now that we've established the value to the practice that we can quickly drive to high percentages of patients on the platform. So yeah, you should be seeing those results of that start to bear fruit in the coming quarters. I also mentioned, there is a lot of cancer care in this country is in fact concentrated at large cancer centers.

因此，這實際上是一個雙管齊下的方法，擴大帳戶，但同樣重要的是，確保當我們在帳戶上時——現在我們已經確定了實踐的價值，我們可以快速推動高比例的患者接受治療。該平台。所以，是的，您應該會看到這些結果在未來幾季開始結出果實。我還提到，這個國家的許多癌症照護其實都集中在大型癌症中心。

And so we have a separate strategic push and are looking forward to locking down and signing up our first large cancer center, there should be obvious the lead times for that since these are large institutions are longer, but once we get there, the payoffs will be great. So we look forward to starting to close accounts at these large cancer centers.

因此，我們有一個單獨的戰略推動，並期待鎖定並簽約我們的第一個大型癌症中心，應該有明顯的準備時間，因為這些大型機構更長，但一旦我們到達那裡，回報就會棒極了。因此，我們期待著開始關閉這些大型癌症中心的帳戶。

On the biopharma side, the commercial opportunity, and the value creation opportunity there is huge. But right now, we're just in initial discussions and we're working out sort of how the structure of us offering Veris as a companion to a cancer therapeutic during the post-market surveillance period, how the mechanics of that will work out. The software development part of it is relatively modest. It's more about working with the pharma companies on how to work out the contractual arrangements and the actual technical aspects of getting these patients who are in the market surveillance phase on the platform. So hopefully that gives you a sense as to what the coming quarters offer.

在生物製藥方面，商業機會和價值創造機會是巨大的。但現在，我們只是在進行初步討論，我們正在研究如何在上市後監測期間提供 Veris 作為癌症治療的伴侶，以及其機制將如何發揮作用。它的軟體開發部分相對較小。更多的是與製藥公司合作，如何制定合約安排以及如何讓這些處於市場監測階段的患者進入平台的實際技術方面。希望這能讓您了解未來幾季會提供什麼。

Yeah, that's good color. And my second question was going to be on the pharma side of the Veris platforms. So maybe I'll continue with that thought process, maybe talk about when we could see some first partnerships across the goal line? And then I know I heard your comment about focusing mostly on the post-FTA approval phase. Maybe talk to why you think that's the most logical area of development to focus on? And if there is still opportunity to work into some of the clinical trials as well on the maybe Phase II or Phase III timeframes.

是的，這個顏色很好。我的第二個問題是關於 Veris 平台的製藥方面。所以也許我會繼續這個思考過程，也許談談我們什麼時候可以看到一些跨越球門線的第一次合作關係？然後我知道我聽到了您關於主要關注自由貿易協定後批准階段的評論。也許談談為什麼你認為這是最值得關注的發展領域？如果仍有機會在第二階段或第三階段的時間範圍內進行一些臨床試驗。

Right. So, thanks for the opportunity to kind of flesh that out a little bit. So there's been an evolution in our strategy and our thinking about this as we've engaged a bit deeper. You know, as you sort of hinted at, our initial focus was on pre-submission and being engaged during the development process during clinical trials in the Phase II and III sides of this so that it actually becomes part of the package FDA submission. And we still think that there's a big opportunity there, the logistics are more complicated, we have to sort of interface with CROs and have our platform work within the CRO platforms where the data is being collected.

正確的。所以，感謝您給我這個機會來充實這一點。因此，隨著我們更深入地參與，我們的策略和對此的思考也發生了變化。你知道，正如你所暗示的那樣，我們最初的重點是預先提交，並參與 II 期和 III 期臨床試驗的開發過程，以便它實際上成為 FDA 提交包的一部分。我們仍然認為那裡有很大的機會，物流更加複雜，我們必須與 CRO 進行某種接口，並讓我們的平台在收集數據的 CRO 平台內工作。

But we think it's a big opportunity, but the lifetime of those are going to be greater, right? Before we actually see potential commercial value in that, we have to follow the drug through its development phase through FDA submission until ultimate FDA approval.

但我們認為這是一個很大的機會，但它們的壽命會更長，對吧？在我們真正看到潛在的商業價值之前，我們必須追蹤該藥物的整個開發階段，直到 FDA 最終批准。

So that opportunity is still there and the work we'll be doing in the early phases of this will, in the module, will be very similar to what it would be for there. But what we've noticed as we dug further into this is that, there really is an immediate opportunity on the post-market surveillance side. So these are drugs that have already been approved, so we're not waiting for that process.

因此，機會仍然存在，我們將在模組的早期階段所做的工作將與那裡的工作非常相似。但當我們進一步深入研究時，我們注意到，上市後監管方面確實存在立即的機會。這些是已經獲得批准的藥物，所以我們不會等待這個過程。

They're in the market, and one of the -- several of the contingencies of their approval is that they have -- that they undergo this market surveillance and they have actual -- they have very well defined care pathways that patients have to go through to be, to qualify for receiving these new drugs. And the process of collecting that data is critical for the drug to move up the chain of treatment. So many of these drugs start as third or fourth line after patients have failed other drugs that have been around for longer periods of time.

他們在市場上，他們批准的幾個偶然因素之一是他們接受了市場監督，並且他們實際上有非常明確的護理途徑，患者必須走這條路直到他們有資格獲得這些新藥。收集數據的過程對於藥物在治療鏈上的升級至關重要。在患者對其他已使用較長時間的藥物無效後，許多這些藥物開始作為第三或第四線藥物。

And so the goal of the company is to move up that food chain in order to do that, to go to first or second line, exponentially expanding the market opportunity. In order to do that they have to demonstrate that they've collected the appropriate post-market surveillance data and documented their safety profile, replicated that in real world. So there's a strong -- there's an immediate opportunity and there's a strong motivation commercially for them to collect that data quickly and collect data in a way that maximizes the likelihood that they'll hit the safety benchmarks.

因此，公司的目標是向食物鏈上游移動，進入第一線或二線，以指數方式擴大市場機會。為了做到這一點，他們必須證明他們已經收集了適當的上市後監測數據並記錄了他們的安全概況，並在現實世界中複製了這一點。因此，他們有一個強大的機會，並且有強烈的商業動機來快速收集數據，並以最大限度地提高達到安全基準的可能性的方式收集數據。

There's also a significant opportunity -- commercial opportunity with the practices which is not really the case in the pre-submission phases of this, which is that, with these new drugs CAR T and others the practices that's actually quite lucrative for a practice to administer that and practices are seek to be certified to administer this, which is important for their bottom line and for their patients to get access to this.

還有一個重要的機會——實踐的商業機會，但在提交前階段的情況並非如此，也就是說，對於這些新藥CAR T 和其他藥物來說，實際上對於管理實踐來說是相當有利可圖的。其和實踐正在尋求獲得管理這一認證，這對於他們的底線和患者獲得這項服務非常重要。

And so, by having the practice have the opportunity to be on a platform that facilitates the participation in this post-market surveillance phase is a win for the practice as well. So in terms of timing, we're -- as I said, we have active discussions with several large pharma companies that you would -- those names you would recognize, and we're still in those early phases, but those are active. And so we certainly hope to see one or more of those consummate in the near future.

因此，讓執業機構有機會進入一個促進參與上市後監督階段的平台，這對執業機構來說也是一個勝利。因此，就時間安排而言，正如我所說，我們與幾家大型製藥公司進行了積極的討論，您會認識這些名字，我們仍處於早期階段，但這些公司正在積極進行。因此，我們當然希望看到其中一項或多項在不久的將來得以完成。

Okay. That's good color. I'll stop there. Thanks for taking the question and congrats on all the progress.

好的。這顏色真好啊我就到此為止。感謝您提出問題並祝賀所有進展。

Thanks, Frank.

謝謝，弗蘭克。

(Operator Instructions)

（操作員說明）

Ed Woo, Ascendiant Capital.

艾德·吳，Ascendian Capital。

Yeah, congratulations on all the progress. You mentioned that for Veris, a big opportunity in the pharma is post-FDA approval. How big of that opportunity is versus drugs that are in clinical trials?

是的，祝賀所有的進展。您提到，對於 Veris 來說，該製藥公司的一個巨大機會是 FDA 批准後。與處於臨床試驗階段的藥物相比，這個機會有多大？

I think it's a large, if not, larger opportunity, but most importantly, it's a more immediate opportunity as opposed to sort of the longer timelines for commercial traction in the pre-submission phase. So as anybody who's paying attention knows, there's been a boon, really almost a revolution that's going on right now in oncology therapeutics. There are drugs that are leveraging breakthroughs in science and immunotherapy and other scientific breakthroughs to deliver drugs at sort of a record pace. So there are numerous oncology drugs that are working their way, that have been approved, that are working their way into real world practice and are -- where the motivation to move up to first and second line is extremely high.

我認為這是一個很大的機會，即使不是更大的機會，但最重要的是，這是一個更直接的機會，而不是在提交前階段的商業吸引力較長的時間表。因此，正如任何關注的人所知道的那樣，腫瘤治療領域正在發生一場福音，幾乎是一場革命。有些藥物正在利用科學和免疫療法的突破以及其他科學突破以創紀錄的速度提供藥物。因此，有許多腫瘤藥物正在發揮作用，已經獲得批准，正在進入現實世界的實踐，並且進入一線和二線的動力非常高。

So I would say that the opportunity at least is great, if not greater. But most importantly, the opportunity -- the timelines of the opportunity for near-term engagement and commercial value is substantially greater in the post-market phase.

所以我想說，這個機會即使不是更大，至少也是很大的。但最重要的是，在上市後階段，短期參與和商業價值機會的時間表要長得多。

For some of those who are not as familiar, it's typically for drugs that are -- therapeutics that are approved. Is there -- like how intensive is the monitoring post-FDA approval?

對於一些不太熟悉的人來說，這通常是針對已批准的治療藥物。 FDA 核准後的監控力道有多大嗎？

Very intensive. So these approvals are in a sense conditional, right? So they are -- they found them to be safe effective in there, typically PMA trials and, and they're -- sorry, their Phase III trials, but they're coming out for real world use with a very stringent requirements for surveillance where data has to be collected to demonstrate in real-world use that the safety profiles that were demonstrated in the Phase III studies are replicated in the real world.

非常密集。所以這些批准在某種意義上是有條件的，對嗎？所以他們 - 他們發現它們在那裡是安全有效的，通常是 PMA 試驗，並且他們 - 抱歉，他們的 III 期試驗，但它們將在現實世界中使用，並具有非常嚴格的監測要求必須收集數據以證明在現實世界中的使用，在第三階段研究中證明的安全性在現實世界中得到了複製。

So there's a significant amount of data being collected. There are significant periods of market surveillance. And the way that the drugs are being delivered are under very strictly defined care pathways. So all of that lends itself to a digital health companion platform. So if you have your approved -- your drug approved, and the agreement with FDA is that you offer it, let's say, as fourth-line therapy, and you have an actual protocol, so the pathway that patients are supposed to undergo, what kind of testing they're supposed to undergo, what their dosing is supposed to be, how their complications are being monitored and reported. All of that is explicitly described in a care pathway that comes with the approval. And so, all of that is very amenable and works well within a digital health platform that we would seek to capture.

因此，正在收集大量數據。有很長一段時間的市場監督。藥物的輸送方式是在非常嚴格定義的護理途徑下進行的。因此，所有這些都適合數位健康伴侶平台。因此，如果你的藥物獲得批准，並且與 FDA 達成的協議是你提供它，比方說，作為四線治療，並且你有一個實際的方案，那麼患者應該接受什麼途徑，什麼他們應該接受什麼樣的測試，他們的劑量應該是多少，如何監測和報告他們的併發症。所有這些都在批准後的護理途徑中明確描述。因此，所有這些都非常適合，並且在我們尋求捕獲的數位健康平台中運作良好。

And then, again, just to reiterate, the real commercial opportunity for the companies is that, if they come out of the gates as a third or fourth line drug, the market is much smaller. And the goal is to use this post-market surveillance phase to demonstrate that the drug should move up the chain of therapy to first or second line drugs, which expands the market dramatically. So really, we think it's a great opportunity and it's one that we think will benefit for modern digital health tools such as our platform.

然後，再次重申，這些公司真正的商業機會是，如果它們作為三線或四線藥物走出大門，市場就會小得多。我們的目標是利用上市後監測階段來證明該藥物應該在治療鏈上升級為第一線或第二線藥物，從而大大擴大市場。所以說真的，我們認為這是一個很好的機會，我們認為這將使我們的平台等現代數位健康工具受益。

Great. Well, thanks for answering my questions and I wish you guys good luck. Thank you.

偉大的。好的，感謝您回答我的問題，祝你們好運。謝謝。

Thanks, Ed. I appreciate it.

謝謝，艾德。我很感激。

Anthony Vendetti, Maxim Group.

安東尼文代蒂，馬克西姆集團。

Good morning, Anthony.

早安，安東尼。

Good morning, Dennis. Good morning, Lishan.

早安，丹尼斯。早安，梨山。

Anthony, how are you?

安東尼，你好嗎？

Good. How are you? So, just to follow up on the major academic cancer centers, obviously that sale cycle is probably fairly lengthy. Would it be accurate to say it's probably somewhere in the 6 to 12 month range? Could it be longer?

好的。你好嗎？因此，只要跟進主要的學術癌症中心，顯然銷售週期可能相當長。說可能在 6 到 12 個月範圍內準確嗎？可以再長一點嗎？

Yes, I think -- I'm sorry. Go ahead.

是的，我想──對不起。前進。

Yeah, and then I know you said a number of centers that you're speaking with. How many total centers are there that you're having conversations with? And sort of -- is that the -- would you qualify those as part of a qualified pipeline you have, or some of them early stage in various forms, maybe just a little more color on that.

是的，然後我知道你提到了與你交談的許多中心。您正在與多少​​個中心進行對話？某種程度上來說，你是否會將這些作為你擁有的合格管道的一部分，或者其中一些處於早期階段的各種形式，也許只是多一點色彩。

Yeah, I'll try to give you some, at least qualitative -- a more deeper qualitative sense of that. So, yes, active discussions, several, I would say, and these are amongst the largest cancer care centers in the country. You're right, lead times can be long, but lead times are going to generally be long for the first one, right? So there's an advantage of being the first one, but there's also more work to get somebody to buy in to being the first one.

是的，我會盡力給你一些，至少是定性的──更深入的定性認識。所以，是的，積極的討論，我想說，這些都是全國最大的癌症護理中心之一。你是對的，交貨時間可能很長，但第一個的交貨時間通常會很長，對嗎？因此，成為第一個是有優勢的，但要讓人們接受成為第一個，還需要做更多的工作。

So I think you referred to it as a qualified pipeline. Yes, I would definitely describe it as that. There are ones in there that are -- where we've made enormous progress, working up through the C-suite, getting people to sign off on, and we think we're making excellent progress to actually consummating, and there are others that are more in -- more early stages of the discussion.

所以我認為您將其稱為合格的管道。是的，我肯定會這樣描述它。其中有一些——我們已經取得了巨大的進展，透過最高管理層的努力，讓人們簽字同意，我們認為我們正在取得巨大的進展，以真正實現目標，還有其他一些更多的是處於討論的更早階段。

I worked in academic medicine for two decades, and I know they're competitive, and we certainly feel like once one has signed on and can brag about their cancer-specific platform that their patients benefit from, there will be some potential competitive juices flowing for others. So yes, I think this is not -- I think there are some potential near-term wins here, and we are filling a pipeline of others along the way, and we'll continue to expand the conversations we have.

我在學術醫學領域工作了二十年，我知道他們很有競爭力，我們當然覺得一旦有人簽約並可以吹噓他們的患者受益的癌症特定平台，就會有一些潛在的競爭優勢為他人。所以，是的，我認為這不是——我認為這裡有一些潛在的近期勝利，我們正在填補其他人的管道，我們將繼續擴大我們的對話。

Okay. And then just switching to the device, I think you provided a lot of color on the opportunity to integrate the Veris platform in clinical trials as well as in the actual post-marketing of these new drugs that are in various stages of coming to market. Maybe just talk about the device itself, the software, there's always -- we hear obviously always about security breaches and there's a lot of unsecured firms out there trying to prevent that. Maybe talk about the development of the software, the monitoring, how comfortable do you feel about the security of that and the HIPAA compliance at this stage, or is that part of the process you're working on at this point.

好的。然後只是切換到該設備，我認為您提供了很多關於將 Veris 平台整合到臨床試驗以及這些處於上市不同階段的新藥的實際上市後的機會的機會。也許只是談論設備本身、軟體，我們顯然總是聽到有關安全漏洞的信息，並且有很多不安全的公司試圖阻止這種情況發生。也許可以談談軟體的開發、監控、您對此階段的安全性和 HIPAA 合規性的感覺如何，或者是您目前正在處理的流程的一部分。

I mean, I'm glad you brought that up. Let me just maybe do a little bit deeper dive of the actual sort of what the device is and how it works and how we've been talking to the FDA about it. So this is effectively the equivalent of the predicate we're using -- predicates we're using are implantable cardiac monitors that are primarily designed for cardiac monitoring. And so, the whole landscape, the whole FDA process, and as well as we'll get to in a second, the standards with regard to cybersecurity are well established for those devices.

我的意思是，我很高興你提出這個問題。讓我更深入地了解該設備的實際類型、它的工作原理以及我們如何與 FDA 討論它。因此，這實際上相當於我們正在使用的謂詞——我們正在使用的謂詞是主要為心臟監測而設計的植入式心臟監視器。因此，整個情況、整個 FDA 流程，以及我們稍後將討論的，這些設備的網路安全標準都已經建立。

They've been around for years, and we're just following in that path. So what our device, how our device differs is that it includes, in addition to the baseline cardiac monitoring, other parameters that we've -- that I enumerated earlier, and it has a form function that allows it to be implanted in conjunction with a vascular access part. It has that divot that you saw that you can snap -- that you can snap those together.

它們已經存在很多年了，而我們只是在追隨這條道路。所以我們的設備，我們的設備的不同之處在於，除了基線心臟監測之外，它還包括我之前列舉的其他參數，並且它具有一種形式功能，允許它與血管通路部分。它有一個你看到的可以折斷的草皮——你可以將它們折在一起。

So, yeah, the development process, we've got multiple world-class partners that are working with us on this that have extensive experience in developing similar devices, whether it be the circuitry, the battery, optimizing software within the device, having the Bluetooth connectivity so that how the data that's collected is transmitted by bluetooth to the patient's phone and ultimately all of that is being handled by, in partnership with firms that have extensive experience in this.

所以，是的，在開發過程中，我們有多個世界級的合作夥伴正在與我們合作，他們在開發類似設備方面擁有豐富的經驗，無論是電路、電池、設備內的優化軟體、藍牙連接，以便將收集的數據透過藍牙傳輸到患者的手機，最終所有這些數據都由在這方面擁有豐富經驗的公司合作處理。

And as I said, it's going extremely well, the FDA has very high standards with regard to how this data gets collected, how it gets transmitted. So many of those standards are built into the FDA process. As I said, we've had numerous interactions with FDA. We're down to our last couple of pre-submission meetings on a couple of the final features that will get us towards the path towards putting together a 510(k) package and submitting it.

正如我所說，進展非常順利，FDA 對於如何收集和傳輸這些數據有非常高的標準。其中許多標準都已納入 FDA 流程中。正如我所說，我們與 FDA 進行了多次互動。我們正在進行最後幾次提交前會議，討論一些最終功能，這些功能將使我們走上整合 510(k) 套件並提交的道路。

The issues that you raise are important and front and center in these kinds of devices these days around cybersecurity and privacy and so forth. All of those are just -- all of those considerations are just deeply built into the design process from day one. So we're not breaking new ground here. We're just taking established best practices and compliance. We have a very robust compliance infrastructure both internally as well as we have dedicated cybersecurity -- a dedicated cybersecurity consultant that frankly works across all of our companies on all of our cybersecurity matters, but obviously is intimately involved in this process as well. So we're very aware of those considerations and all that work is being done with a very robust theme and with really careful attention to the requirements as well as best practice.

您提出的問題非常重要，並且是當今此類設備中圍繞網路安全和隱私等問題的前沿和中心。所有這些都是——所有這些考慮因素從第一天起就深深地融入設計過程中。所以我們不會在這裡開闢新天地。我們只是採用既定的最佳實踐和合規性。我們在內部擁有非常強大的合規基礎設施，並且擁有專門的網路安全人員——專門的網路安全顧問，坦率地在我們所有公司的所有網路安全事務上工作，但顯然也密切參與了這一過程。因此，我們非常清楚這些考慮因素，並且所有工作都是以非常強大的主題完成的，並且非常仔細地關注需求和最佳實踐。

Excellent. That's a great color. And then maybe switching just briefly to Lucid, I know you did the call yesterday. You have a new revenue cycle management firm that seems to be producing the results that you're looking for. I guess on the call, Dennis you mentioned that based on the trends and where you're at, fourth quarter could be on track for $1 million or a little bit north of $1 million. It was that accurate? I didn't know if I heard that correctly, but maybe just summarize that a little bit for me. Thanks.

出色的。這是一個很棒的顏色。然後可能會短暫地切換到 Lucid，我知道你昨天打了電話。您有一家新的收入週期管理公司，它似乎正在產生您正在尋找的結果。我猜丹尼斯在電話會議上提到，根據趨勢和目前的情況，第四季的收入可能會達到 100 萬美元或略高於 100 萬美元。有那麼準確嗎？我不知道我聽得是否正確，但也許只是為我總結一下。謝謝。

Yes, that's correct. For the first six weeks of the quarter, the average weekly collections are about 33% higher than the average for the entire prior quarter. So just doing the simple math, you're correct, it's trending to over $1 million in collections for the fourth quarter.

對，那是正確的。在本季的前六週，平均每週收款量比整個上一季的平均收款量高出約 33%。簡單算一下，你是對的，第四季的收藏金額趨於超過 100 萬美元。

Okay, excellent. Thanks very much. I appreciate it. I'll hop back into the queue.

好的，非常好。非常感謝。我很感激。我會跳回隊列。

Thanks Anthony.

謝謝安東尼。

Ladies and gentlemen, this concludes our question and answer session. I would like to now turn the conference back over to management for any closing remarks.

女士們先生們，我們的問答環節到此結束。我現在想將會議轉交管理層發表閉幕詞。

Great. Hey, thank you everyone for your time. Thank you for the excellent questions. Really excited about this past quarter for PAVmed and its subsidiaries, particularly the strong quarter that Lucid Added. We look forward to continuing on that progress. As always, feel free to -- we'll continue to update you through quarterly calls and press releases, but in the interim, feel free to contact us with any questions, you can contact Mike Park at mep@pavmed.com. So thank you for your time and attention, and have a great day.

偉大的。嘿，謝謝大家的寶貴時間。感謝您提出的精彩問題。對於 PAVmed 及其子公司上個季度的表現感到非常興奮，尤其是 Lucid 添加的強勁季度。我們期待著繼續取得這項進展。一如既往，我們將繼續透過季度電話和新聞稿向您通報最新情況，但在此期間，如有任何問題，請隨時與我們聯繫，您可以透過 mep@pavmed.com 聯繫 Mike Park。感謝您的時間和關注，祝您有美好的一天。

This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines, and have a wonderful day.

今天的電話會議到此結束。我們感謝大家參加今天的演講。您現在可以斷開線路，度過美好的一天。