PAVmed Inc (PAVM) 2024 Q3 法說會逐字稿

Good morning, and welcome to the PAVmed's third-quarter 2024 business update conference call. (Operator Instructions) Please note this event is being recorded.

早安，歡迎參加 PAVmed 2024 年第三季業務更新電話會議。（操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Matt Riley, PAVmed Director of Investor Relations. Please go ahead.

我現在想將會議交給 PAVmed 投資者關係總監 Matt Riley。請繼續。

Thank you, operator, and good morning, everyone. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer of PAVmed; along with Dennis McGrath, Chief Financial Officer of PAVmed.

謝謝接線員，大家早安。感謝您參加今天的業務更新電話會議。今天與我一起參加電話會議的還有 PAVmed 董事長兼執行長 Lishan Aklog 博士；以及 PAVmed 財務長 Dennis McGrath。

The press release announcing our business update and financial results is available on PAVmed's website. Please take a moment to read the disclaimers about forward-looking statements in the press release. The business update press release and the conference call all 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 the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission.

宣布我們業務更新和財務表現的新聞稿可在 PAVmed 網站上取得。請花一點時間閱讀新聞稿中有關前瞻性陳述的免責聲明。業務更新新聞稿和電話會議均包含前瞻性陳述，這些前瞻性陳述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所做的陳述有重大差異。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。

For a list and a description of these and other important risks and uncertainties that may affect future operations, see Part I, Item IA entitled Risk Factors in PAVmed's most recent annual report on Forms 10-K filed with the SEC and any subsequent updates filed in the quarterly reports on Forms 10-Q and subsequent Forms 8-K.

有關這些以及可能影響未來營運的其他重要風險和不確定性的清單和說明，請參閱PAVmed 向SEC 提交的10-K 表格最新年度報告中標題為「風險因素」的第I 部分第IA 項以及在SEC 提交的任何後續更新。

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 the 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。

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

現在我想將電話轉給 PAVmed 董事長兼執行長 Lishan Aklog 博士。

Take it away, Lishan.

拿走吧，梨山。

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. As always, I'd like to thank our long-term shareholders for your ongoing support and commitment. . Before we delve into our recent operational highlights, I'd like to make a few high-level points.

謝謝你，馬特，大家早安。感謝您參加我們的季度更新電話會議。一如既往，我要感謝我們的長期股東的持續支持和承諾。。在我們深入研究最近的營運亮點之前，我想先提出一些要點。

This has been a transformational quarter for PAVmed. Over the last couple of quarters, we've taken several critical steps related to PAVmed's corporate structure and balance sheet. This strategic transformation, which is now essentially complete, put PAVmed in the strong position to fulfill its mission on behalf of its shareholders.

對於 PAVmed 來說，這是一個變革性的季度。在過去的幾個季度中，我們採取了與 PAVmed 的公司結構和資產負債表相關的幾個關鍵步驟。這項策略轉型現已基本完成，使 PAVmed 處於有利地位，能夠代表股東履行其使命。

As a result, PAVmed is now a sustainable vehicle that's capable of doing precisely what it was designed to do, deliver innovative medical technologies that address unmet clinical needs. The first step was the recent deconsolidation of Lucid Diagnostics, Dennis will provide greater context on this later on the call. But the most important thing this step accomplished was to preserve PAVmed's ownership in Lucid without having to absorb Lucid's operating losses on its balance sheet.

因此，PAVmed 現在是一種可持續的工具，能夠準確地完成其設計任務，提供創新的醫療技術來解決未滿足的臨床需求。第一步是最近對 Lucid Diagnostics 進行了拆分，丹尼斯將在稍後的電話會議上提供更多相關背景資訊。但這一步完成的最重要的事情是保留 PAVmed 對 Lucid 的所有權，而不必在其資產負債表上吸收 Lucid 的營運損失。

The second step, which again, Dennis will provide further details on later, was the restructuring of our convertible debt, which will allow us to preserve our Nasdaq listing.

第二步是重組我們的可轉換債務，這將使我們能夠保留在納斯達克的上市地位，丹尼斯稍後將提供更多細節。

So where are we now? PAVmed is now well positioned to operate as a diversified commercial life sciences company with multiple independently financed subsidiary operating under a shared services model. Our portfolio includes Lucid Diagnostics, our publicly traded diagnostics company, which, of course, remains PAVmed's strongest asset.

那我們現在在哪裡？PAVmed 現在已成為一家多元化商業生命科學公司，擁有多個獨立資助的子公司，在共享服務模式下運作。我們的投資組合包括我們的上市診斷公司 Lucid Diagnostics，它當然仍然是 PAVmed 最強大的資產。

Veris Health is our digital health company, which offers a Cancer Care Platform that enhances personalized cancer care. And our incubator, PMX is advancing promising technologies in our portfolio, starting now with the PortIO, implantable intraosseous device. Our shared services model allows us the flexibility to bring in new assets and technologies in our portfolio, which we continue to actively pursue. With this strategic transformation, I really couldn't be more excited about the future of PAVmed and its subsidiaries.

Veris Health 是我們的數位健康公司，提供可增強個人化癌症護理的癌症護理平台。我們的孵化器 PMX 正在推進我們產品組合中的有前景的技術，從 PortIO（植入式骨內設備）開始。我們的共享服務模式使我們能夠靈活地在我們的產品組合中引入新的資產和技術，我們將繼續積極追求這一點。透過這次策略轉型，我對 PAVmed 及其子公司的未來感到非常興奮。

So let's go on to highlights from the third quarter and recent weeks. Let's start with Lucid Diagnostics. First, let me encourage you to listen to yesterday's Lucid business update call for greater details. We are happy to report record revenue in the third quarter. Our revenue increased 20% quarter-on-quarter.

讓我們繼續回顧第三季和最近幾週的亮點。讓我們從清醒診斷開始。首先，我鼓勵您收聽昨天的 Lucid 業務更新電話會議，以了解更多詳細資訊。我們很高興地報告第三季創紀錄的收入。我們的營收季增 20%。

We published the ESOGUARD BE-1 clinical validation study, which is accepted for peer review publication, and that is the final piece that now completes our clinical evidence package for us to formally submit seeking Medicare coverage. We've held 3 productive meetings with the CMS Medicare contractors, MolDX program, focused on this upcoming submission for EsoGuard coverage.

我們發表了 ESOGUARD BE-1 臨床驗證研究，該研究已接受同行評審出版，這是目前完成我們臨床證據包的最後一項研究，可供我們正式提交尋求醫療保險承保的申請。我們與 CMS Medicare 承包商 MolDX 計劃舉行了 3 次富有成效的會議，重點是即將提交的 EsoGuard 承保範圍。

Finally, as we recently announced, we've expanded our direct contracting initiative with multiple programs, including newly in the concierge medicine and expansion of the employer market side to focus on driving near-term revenue.

最後，正如我們最近宣布的那樣，我們透過多個計劃擴大了直接簽約計劃，包括新的禮賓醫療和擴大雇主市場方面，以專注於推動短期收入。

A lot of great developments with Veris Health, our pilot with The Ohio State University, The James Cancer Center, is now complete, and we are in active discussions with the institution on long-term commercial and strategic partnerships. We are happy to have received a $1.8 million NIH grant, which will allow us to further optimize the Veris Cancer Care Platform, specifically for our medically underserved patients in partnership with an academic cancer center.

我們與俄亥俄州立大學詹姆斯癌症中心的試點計畫 Veris Health 的許多重大進展現已完成，我們正在與該機構就長期商業和戰略合作夥伴關係進行積極討論。我們很高興獲得 180 萬美元的 NIH 撥款，這將使我們能夠進一步優化 Veris 癌症護理平台，特別是與學術癌症中心合作，針對醫療服務不足的患者。

We had initiated a capital raise for Veris, but put that on hold during the restructuring process and are looking forward to reinitiating that shortly. We're also preparing to relaunch the development of the implantable monitor. On the PMX incubator side, we're continuing the process of seeking our direct financing to fund the PortIO device.

我們已經為 Veris 發起了融資，但在重組過程中擱置了，並期待很快重新啟動。我們也準備重新啟動植入式監視器的開發。在 PMX 孵化器方面，我們正在繼續尋求直接融資來為 PortIO 設備提供資金。

With that, I'm going to hand the baton over to Dennis to give us our financial update.

至此，我將把接力棒交給丹尼斯，讓他向我們通報最新的財務狀況。

Thanks, Lishan, and good morning, everyone. The summary of financial results for the third quarter were reported in our press release that has been distributed.

謝謝李山，大家早安。我們已分發的新聞稿中報告了第三季的財務業績摘要。

On the next 4 slides, I'll emphasize on 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 as filed with the SEC.

在接下來的 4 張投影片中，我將強調本季度的一些關鍵亮點，但我鼓勵您在向 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。

With regard to the balance sheet, as you can see from the slide, things look very different comparing the third quarter to the previous quarter as a result of the deconsolidation of Lucid from PAVmed. That comment will also hold true for the P&L once I get there as well.

關於資產負債表，正如您從幻燈片中看到的那樣，由於 Lucid 從 PAVmed 中分拆，第三季度與上一季相比看起來非常不同。一旦我到達那裡，這個評論也適用於損益表。

Before I dive into the details explaining financial results for the third quarter, it's best to provide some insight as to the master plan and the intentional steps that management and the Board have taken and are continuing to take to both maintain the Nasdaq listing and also move PAVmed to be on a more stable financial footing as I'll demonstrate 2 slides after this one.

在我深入解釋第三季財務業績的細節之前，最好先介紹一下總體規劃以及管理層和董事會為維持納斯達克上市和搬遷而已經採取和繼續採取的有意步驟。的財務基礎，因為我將在這張投影片之後示範兩張投影片。

On October 29, in a formal hearing we presented the Nasdaq a 2-step plan to satisfy the continued listing for the Nasdaq capital market and therefore, maintain our Nasdaq listing for at least the next 12 months. Structures in place that we believe may allow us to sustain compliance for much longer. The minimum requirement that we had to demonstrate to Nasdaq was that the company could achieve GAAP stockholders' equity greater than $2.5 million and be able to sustain that minimum for more than 12 months. Our starting point was a deficit of $18.6 million as of June 30.

10 月29 日，在正式聽證會上，我們向納斯達克提交了一份兩步計劃，以滿足納斯達克資本市場的持續上市要求，從而至少在未來12 個月內維持我們在納斯達克的上市地位。我們相信現有的結構可以讓我們更長時間地維持合規性。我們必須向納斯達克證明的最低要求是，公司可以實現 GAAP 股東權益超過 250 萬美元，並且能夠維持這一最低水準超過 12 個月。截至 6 月 30 日，我們的起點是赤字 1,860 萬美元。

We were notified last Friday night that Nasdaq accepted that plan, which I'll describe in a moment, granting an extension through January 31, 2025, to get the final step, which is subject to shareholder approval being completed.

上週五晚上我們接到通知，納斯達克接受了該計劃，我將在稍後描述該計劃，並同意將期限延長至2025 年1 月31 日，以完成最後一步，這需要股東批准完成。

Step one was to deconsolidate Lucid from PAVmed, which, as you know, was accomplished on September 10. The details are described in the 8-K filed with the SEC in mid-September are also more fully described in our PAVmed 10-Q. But essentially, the deconsolidation requirement was accomplished by first, changing Board compositions such as the majority of the members of the Lucid Board were no longer also PAVmed directors.

第一步是從 PAVmed 中剝離 Lucid，如您所知，這項工作已於 9 月 10 日完成。9 月中旬向 SEC 提交的 8-K 中描述了詳細信息，我們的 PAVmed 10-Q 中也有更全面的描述。但本質上，解除合併的要求是透過先改變董事會組成來實現的，例如 Lucid 董事會的大多數成員不再是 PAVmed 董事。

And secondly, eliminating a few voting proxies that certain shareholders had granted over their Lucid shares in favor of the PAVmed office. PAVmed continues to be the single largest shareholder of the common stock. However, the controlling voting interest dropped from more than 50% to about 40% as a result of these intentional actions by management and the Board, clearing the pathway to deconsolidate Lucid from PAVmed. This action alone cut the third quarter shareholder deficit in half from the previous quarter's balance. The 10-Q footnote number four to the financial statements provides a lot more detail on this impact.

其次，取消了某些股東為其 Lucid 股票授予的一些投票代理權，轉而支持 PAVmed 辦公室。PAVmed 仍然是普通股的單一最大股東。然而，由於管理層和董事會的這些有意行動，控股投票權從 50% 以上下降至 40% 左右，為從 PAVmed 中剝離 Lucid 掃清了道路。光是這項行動就將第三季股東赤字比上一季的餘額減少了一半。財務報表的 10-Q 腳註第四項提供了有關此影響的更多詳細資訊。

Step two, required restructuring the convertible debt. PAVmed and the convertible debt holder have agreed, subject to certain conditions, that I'll get into in a moment, to exchange $25 million of existing obligations for newly created Series [ C ] convertible preferred stock of an equivalent value. Thereby not only wiping out the deficit, but also allowing us to demonstrate the Nasdaq a plan for sustainable compliance with the continued listing standard for a meaningful period of time.

第二步，要求重組可轉換債務。PAVmed 和可轉換債務持有人已同意，在滿足某些條件的情況下，我將立即討論，將 2500 萬美元的現有債務交換為新創建的等值系列 [C] 可轉換優先股。從而不僅消除了赤字，而且還使我們能夠向納斯達克展示一項在一段有意義的時間內可持續遵守持續上市標準的計劃。

The effective date of the exchange is subject to a few conditions. First, before the exchange agreement will become effective, our accounting advisers need to complete their final quality review steps of their independent analysis to concur with our internal assessment that after the debt for preferred exchange is completed, the preferred stock will be classified as GAAP permanent equity.

交換的生效日期取決於一些條件。首先，在交換協議生效之前，我們的會計顧問需要完成獨立分析的最終品質審查步驟，以與我們的內部評估一致，即在優先交換債務完成後，優先股將被歸類為 GAAP 永久股公平。

The company hired BDO to complete an independent analysis with regard to the likely permanent equity classification. That analysis is being reviewed by our auditors. We are awaiting the completion of that review, which is expected shortly. Upon satisfactory completion of that review and an affirmative conclusion about the likelihood of permanent equity classification, the exchange agreement will become effective.

該公司聘請了 BDO 來完成有關可能的永久股權分類的獨立分析。我們的審計師正在審查該分析。我們正在等待審查的完成，預計很快就會完成。在圓滿完成審查並就永久股權分類的可能性得出肯定結論後，交換協議將生效。

Second, we have agreed with our debt holder that the consummation of the exchange is subject to shareholder approval of certain customary measures that would allow for the full conversion of the Series C preferred stock. We expect to file a shareholder proxy shortly for a special meeting of the shareholders to request approval of these measures and shortly thereafter close the exchange, well in advance of the January 31, 2025, extended deadline for regaining compliance with Nasdaq.

其次，我們已與債務持有人達成一致，即交換的完成須經股東批准某些慣例措施，以實現 C 系列優先股的完全轉換。我們預計很快就會提交一份股東委託書，召開股東特別會議，請求批准這些措施，並在不久之後關閉交易所，遠早於2025 年1 月31 日（恢復納斯達克合規的延長期限）。

Additional tactical steps being taken by management and the Board. The incurrence of future R&D expenses to advance the next development stages of the Veris Cancer Care Platform and PortIO technology will be largely dependent upon obtaining direct funding into those entities to cover the incremental development costs. Hence, any increased burn from those endeavors will be offset by the incremental financing. As a good start in that direction, we previously announced being awarded a National Institute of Health grant of $1.8 million from Veris. We have also circulated a Veris offering memorandum at a $35 million pre-money valuation and received an indication of interest to fund the first tranche for the implantable devices next steps.

管理階層和董事會正在採取其他戰術措施。未來推進 Veris 癌症護理平台和 PortIO 技術下一開發階段的研發費用將在很大程度上取決於這些實體獲得直接資金以支付增量開發成本。因此，這些努力增加的資金消耗將被增量融資所抵銷。作為朝這個方向的良好開端，我們先前宣布獲得 Veris 授予的美國國立衛生研究院 180 萬美元撥款。我們還分發了一份 Veris 發行備忘錄，投前估值為 3500 萬美元，並收到了有興趣為植入式設備後續步驟提供第一筆資金的意向。

This funding effort has been paused pending the outcome of the hearings panel meeting on October 29. Receiving Nasdaq's letter of approval last Friday was a key factor now moving those funding efforts forward.

這項資助工作已暫停，等待 10 月 29 日聽證小組會議的結果。上週五收到納斯達克的批准信是目前推動這些融資工作向前發展的關鍵因素。

Additionally, for PortIO, we've entered into a term sheet with an angel fund for a direct investment in PortIO Corp at a pre-money valuation of $42 million to cover the final development steps. The angel fund is in the process of conducting its diligence with our team.

此外，對於 PortIO，我們已與天使基金簽訂了一份條款清單，以 4,200 萬美元的投前估值直接投資 PortIO Corp，以涵蓋最終的開發步驟。天使基金正在與我們的團隊進行盡職調查。

So now for the comparative analysis. Two immediate things to notice on PAVmed's balance sheet presentation. One, Lucid's cash is no longer consolidated in the presentation of PAVmed's cash balance. However, equally important is that for the first time, PAVmed's balance sheet presents the inclusion of the $25.5 million market value of its 31.3 million Lucid share ownership. Previously, that inclusion was eliminated out of PAVmed's presentation due to [ GAAP's ] intercompany consolidation rules.

那麼現在進行比較分析。PAVmed 的資產負債表演示中有兩點需要立即註意。第一，Lucid 的現金不再合併在 PAVmed 現金餘額的列報中。然而，同樣重要的是，PAVmed 的資產負債表首次包含了其 3,130 萬股 Lucid 股權的 2,550 萬美元市場價值。先前，由於 [ GAAP ] 公司間合併規則，該內容已從 PAVmed 的簡報中刪除。

Furthermore, as Lucid's stock price rises, like it has since September 30 balance sheet date, this amount will increase. For instance, the balance and PAVmed-related net equity has increased by more than $6 million from the balance sheet date of September 30 through earlier this week. PAVmed stand-alone burn rate for the third quarter is about a breakeven once you strip lose it out of the results. You'll see that illustrate it as I address it further in 2 slides from now.

此外，隨著 Lucid 股價的上漲（自 9 月 30 日資產負債表日以來的情況），這筆金額將會增加。例如，從 9 月 30 日資產負債表日到本週早些時候，餘額和 PAVmed 相關淨資產增加了超過 600 萬美元。一旦將損失從結果中剔除，PAVmed 第三季的獨立燒錢率大約是損益平衡。當我在接下來的 2 張投影片中進一步闡述這個問題時，您將會看到這一點。

Finishing this slide. The change in other assets is largely related to the Lucid deconsolidation. The amount of convertible notes reflects deconsolidating Lucid's convertible note from the prior balance and before the effect of the proposed $25 million exchange into preferred, which will happen after the shareholder vote.

完成這張投影片。其他資產的變化很大程度上與Lucid分拆有關。可轉換票據的金額反映了 Lucid 的可轉換票據從先前的餘額中以及在擬議的 2500 萬美元兌換為優先股的效果之前（這將在股東投票之後發生）的情況。

Shares outstanding, including unvested restricted stock awards, $11 million. The GAAP outstanding shares of 10.7 million are reflected on the slide as well as on the face of the balance sheet in the 10-Q.

已發行股票（包括未歸屬的限制性股票獎勵）為 1,100 萬美元。1,070 萬股的 GAAP 流通股反映在投影片以及 10 季資產負債表的表面。

Similar to past presentations, this P&L slide provides some GAAP and non-GAAP sequential quarterly comparisons as well as year-over-year information. However, there are some significant differences in how the information is compiled between the comparative periods given the changes in PAVmed's financial control of Lucid.

與過去的簡報類似，這張損益投影片提供了一些 GAAP 和非 GAAP 連續季度比較以及同比資訊。然而，鑑於 PAVmed 對 Lucid 財務控制的變化，比較期間之間的資訊編制方式存在一些重大差異。

Importantly, the GAAP construct for deconsolidating Lucid on September 10, somewhat blurs the understanding of the information for PAVmed as a stand-alone entity and GAAP does not allow the presentation for the prior periods to be similarly adjusted. The GAAP third quarter results is presented, reflecting inclusion or consolidation of Lucid's results for 2 and one-third months, July 1 through September 10. And differently, for the two-thirds of the remainder of September, that is September 11 through September 30 because Lucid's results are not included.

重要的是，9 月 10 日拆分 Lucid 的 GAAP 結構在一定程度上模糊了對 PAVmed 作為獨立實體的資訊的理解，並且 GAAP 不允許對前期的列報進行類似調整。公佈了 GAAP 第三季業績，反映了 Lucid 從 7 月 1 日到 9 月 10 日這兩個又三分之一個月的業績。不同的是，對於 9 月剩餘時間的三分之二，即 9 月 11 日至 9 月 30 日，因為 Lucid 的結果不包括在內。

Furthermore, you can see a large net income of $61 million on the GAAP P&L. This is before the non-controlling interest. And positive primary EPS of $6.43 per share and a positive diluted EPS of $1.44 per share. This is all the result of eliminating Lucid from PAVmed's balance sheet and extracting the impact of Lucid's cumulative historical losses. The net adjustments to the balance sheet create a $72 million gain that then flows through the P&L to obtain the net equity impact of all of the deconsolidation adjustments.

此外，您還可以在 GAAP 損益表上看到高達 6,100 萬美元的淨利。這是扣除非控制權益之前的資料。主要每股收益為正值 6.43 美元，攤薄每股收益為正值 1.44 美元。這都是將 Lucid 從 PAVmed 的資產負債表中剔除並提取 Lucid 累積歷史損失影響的結果。資產負債表的淨調整產生了 7,200 萬美元的收益，然後該收益流經損益表以獲得所有取消合併調整的淨權益影響。

Happy to answer any detailed questions on the slide in the Q&A. But I think it's more informative by pulling apart the deconsolidation chaos and illuminating what PAVmed on a stand-alone basis looks like. That's what I hope to achieve on this next slide.

很高興回答問答幻燈片中的任何詳細問題。但我認為，透過理清解散混亂並闡明 PAVmed 在獨立基礎上的樣子，可以提供更多資訊。這就是我希望在下一張投影片中實現的目標。

Next slide, please. I trust you'll review this information on this pro forma presentation and my comments in light of the cautionary disclosure on the bottom of the previous slide about supplemental information, particularly the non-GAAP information that's presented. The first column on this slide provides an exact snapshot of the statement of operations directly from the 10-Q.

請下一張投影片。我相信您會根據上一張投影片底部有關補充資訊（特別是所提供的非 GAAP 資訊）的警告性披露，請查看本備考簡報中的資訊和我的評論。本投影片的第一列提供了直接來自 10-Q 的營運報表的準確快照。

The three columns in the middle serve to explain or illustrate three critical steps. Column 2, it isolates and takes out the $72 million gain purely from the deconsolidation effort. This is a result of identifying all of the Lucid's balance sheet-specific assets, their liabilities, their equity counts, all bedded in the PAVmed balance sheet on September 10 and taking them out of the PAVmed totals, creates a net difference of $72 million, and therefore, the consequent gain that flows through the P&L, obviously, not a recurring item.

中間的三欄用來解釋或說明三個關鍵步驟。第 2 欄，它隔離並取出了純粹來自拆分工作的 7,200 萬美元收益。這是確定Lucid 的所有資產負債表特定資產、負債、權益計數的結果，所有這些都包含在9 月10 日的PAVmed 資產負債表中，並將它們從PAVmed 總額中剔除，產生了7,200 萬美元的淨差額，因此，流經損益表的後續收益顯然不是經常性項目。

Column 3 deals with isolating Lucid's net P&L revenue and net operating expenses for the period July 1 through September 10 and then adjusting them out of the PAVmed's GAAP reported results. Column 4 isolates the need to include the full cash MSA fee for July 1 through September 10 and that had been eliminated for the period of time that Lucid's results were consolidated into the GAAP P&L because of intercompany-related parting GAAP rules.

第 3 欄涉及分離 7 月 1 日至 9 月 10 日期間 Lucid 的淨損益收入和淨營運支出，然後將其從 PAVmed 的 GAAP 報告結果中進行調整。第4 欄隔離了包含7 月1 日至9 月10 日期間全額現金MSA 費用的必要性，並且由於與公司間相關的分拆GAAP 規則，Lucid 的業績併入GAAP 損益表期間該費用已被消除。

Column 5 illustrates what the third quarter would look like on a stand-alone basis for the entire quarter on a pro forma presentation. Focusing on the bottom line, you can see a GAAP loss of about $1.6 million, but after taking out the noncash charges for depreciation and stock-based compensation, and other non-GAAP adjustments like the non-cash charges related to the debt results in a small profit, essentially a breakeven scenario.

第 5 欄說明了預計簡報中整個季度的第三季的獨立情況。關注底線，您可以看到 GAAP 損失約為 160 萬美元，但在扣除折舊和股票補償的非現金費用以及其他非 GAAP 調整（例如與債務相關的非現金費用）後，微薄的利潤，基本上是損益平衡的情況。

Next slide, please. With regard to non-GAAP operating expenses. On this slide, you'll see a graphic illustration of our operating expenses over time as presented in detail in our press release. Total non-GAAP operating expense is $10.1 million for the third quarter of '24. The decrease is equally related to: a, the impact of the deconsolidation; and b, the fact that the combined operating expenses, ignoring deconsolidation for both PAVmed and Lucid would have been in line with previous quarters.

請下一張投影片。關於非公認會計準則營運費用。在此投影片上，您將看到我們隨時間推移的營運支出的圖解，如我們的新聞稿中詳細介紹的。2024 年第三季的非 GAAP 營運費用總額為 1,010 萬美元。這種減少同樣與以下因素相關： a、 拆分的影響； b，忽略 PAVmed 和 Lucid 的合併營運費用，合併營運費用與前幾季保持一致。

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）

Ross Osborn, Cantor Fitzgerald.

羅斯·奧斯本，康托·菲茨杰拉德。

Maybe starting off, could you share any learnings from your work with The Ohio State?

也許首先，您能分享一下您在俄亥俄州立大學工作中學到的東西嗎？

Sure. Yes. So just to catch folks up, we've had a really strong engagement with them now coming on, I think, probably about a year since we initially engaged with them. And we launched -- we entered into a memorandum of understanding with the -- this is The James Cancer Center within Ohio State University Medical Center. It's the third largest cancer center of the country and an NCI-designated comprehensive cancer center.

當然。是的。因此，為了跟上人們的步伐，我們與他們進行了非常密切的接觸，我想，距離我們最初與他們接觸大約一年了。我們啟動了——我們與俄亥俄州立大學醫學中心內的詹姆斯癌症中心簽署了一份諒解備忘錄。它是美國第三大癌症中心，也是 NCI 指定的綜合癌症中心。

We entered into a memorandum of understanding with them earlier this year that called for a first step of a pilot program with the institution that ran through the summer. It enrolled 100 patients on the Veris platform and has actually now been extended for another 30 patients because one of the clinical sites was -- that wasn't a participant in the initial pilot, was honestly clamoring to be a part of it.

今年早些時候，我們與他們簽署了一份諒解備忘錄，要求與該機構在整個夏天進行試點計劃的第一步。它在 Veris 平台上招募了 100 名患者，實際上現在已擴展到另外 30 名患者，因為其中一個臨床中心並未參與最初的試點，但卻真誠地呼籲加入其中。

The pilot was highly structured. It had KPIs of metrics with regard to patient, physician satisfaction and other key parameters and that's been completed and was, frankly, widely successful with great feedback from all corners of the institution, from the administration to the leadership.

此試點計畫結構嚴謹。它有關於患者、醫生滿意度和其他關鍵參數的 KPI 指標，並且已經完成，坦率地說，該項目取得了廣泛的成功，得到了從行政部門到領導層的機構各個方面的良好反饋。

So we're now in the process of having discussions with the leadership to follow up on other aspects of the -- that were articulated in the Memorandum of understanding, which would sort of fall under the broad umbrella of a strategic partnership with escalating commercial engagement. So those are active discussions right now. There's a lot of activity with -- between the -- between us and the institution at telling the story of their experience with this pilot and how the various platform is able to enhance and personalize the care of those cancer patients.

因此，我們現在正在與領導層進行討論，以跟進諒解備忘錄中闡明的其他方面，這在某種程度上屬於戰略夥伴關係的廣泛保護範圍，並不斷升級商業參與。所以這些現在正在積極討論。我們和該機構之間進行了許多活動，講述他們在該試點計畫中的經歷，以及各個平台如何能夠增強和個人化對癌症患者的照護。

And this engagement, our goal is for this to serve as a template as we enter into similar discussions with a pipeline of some of our academic cancer centers around the country.

我們的目標是，當我們與全國各地的一些學術癌症中心進行類似的討論時，我們的目標是以此為模板。

Okay. Great. And then I guess maybe regarding OpEx for PAVmed. How should we think about that in the coming quarters? I'm assuming maybe pretty steady ahead of any incremental financing?

好的。偉大的。然後我想也許是關於 PAVmed 的營運支出。在未來幾季我們應該如何考慮這一點？我假設在任何增量融資之前可能相當穩定？

Yes. So as we presented in that pro forma slide, you can see the kind of the normalized OpEx moving forward. That's our baseline. As we generate the direct financing either in Veris or in PortIO, that will be the gating factor to now incur the additional operating expenses. In Veris' case, moving it towards the implantable.

是的。因此，正如我們在預計幻燈片中所介紹的那樣，您可以看到標準化營運支出的類型正在向前發展。這是我們的底線。當我們在 Veris 或 PortIO 中產生直接融資時，這將成為現在產生額外營運費用的限制因素。就 Veris 而言，正在將其轉向植入式。

That's probably a couple of million dollar efforts over a 6- to 8-month period of time. And likewise, in PortIO, with the financing, it's probably about a $4 million expenditure probably over a 12-month period of time. And it is those aspects of change in funding that will drive where the OpEx goes.

這可能需要在 6 至 8 個月的時間內投入數百萬美元。同樣，在 PortIO 中，在 12 個月的時間內，融資支出可能約為 400 萬美元。正是資金變化的這些面向將推動營運支出的走向。

But otherwise, the pro forma that's illustrated on that slide is the baseline and should continue going forward. is a likely representation of the fourth quarter and with the funding, the changes that may occur in 2025.

但除此之外，該投影片中所示的預計數據是基線，應該繼續前進。是第四季的可能代表，隨著資金的增加，2025 年可能發生的變化。

Anthony Vendetti, Maxim Group.

安東尼文代蒂，馬克西姆集團。

Just a little more follow-up on the Veris program. So assuming you get the financing and so forth, is it still on track for submission with the FDA on a 510(k) basis before the first half of '25?

關於 Veris 計劃的更多後續行動。因此，假設您獲得了融資等，是否仍有望在 25 年上半年之前以 510(k) 為基礎向 FDA 提交？

I think it may -- we've -- because of the delay in closing the financing, which was necessary as a result of the restructuring and just sort of wrapping up the efforts to fix the listing requirement, it may leak into the early half of the second half, but hopefully not by much.

我認為我們可能會因為推遲完成融資而推遲融資（這是重組所必需的），並且只是結束了確定上市要求的努力，所以融資可能會滲透到上半年下半場，但希望不會太多。

Okay. Great. And then in terms of the financing for the PMX incubator, you said you have lined up some financing already. How much total funding.....

好的。偉大的。然後在 PMX 孵化器的融資方面，您說您已經安排了一些融資。總資金是多少......

Let me clarify that. So we've engaged with an angel network that -- and we have a turf sheet in place, and Dennis explained the terms of that, which are attractive to raise $4 million, which covers the expenses of the second-generation PortIO as well as completing the [ IDE ] clinical trial to commercialization. That was at a $42 million pre-money valuation.

讓我澄清一下。因此，我們已經與天使網絡合作，我們已經制定了草稿，丹尼斯解釋了其中的條款，這對籌集 400 萬美元很有吸引力，其中包括第二代 PortIO 的費用以及完成[IDE]臨床試驗至商業化。投資前估值為 4,200 萬美元。

So that term sheet has been finalized and negotiated. We are at the very end, they have a very rigorous diligence process, and we're at the very end of that process. And we expect the diligence report to be wrapped up soon. And then the network will go to its individual members and start circulating the opportunity and start raising the cash over the -- and collecting subscription agreements over the -- in the near term.

因此，該條款清單已最終確定並經過談判。我們處於最後階段，他們有非常嚴格的盡職調查流程，我們也處於流程的最後階段。我們預計盡職調查報告將很快完成。然後該網路將向其個人成員提供機會，並開始在短期內籌集現金並收取訂閱協議。

Ed Woo, Ascendiant Capital.

艾德·吳，Ascendian Capital。

Yes. Congratulations on all your progress. My question is on The Ohio State pilot. What does the competitive slate looks like? Were you guys competing against other diagnostic, remote diagnostic devices?

是的。恭喜您所取得的所有進步。我的問題是關於俄亥俄州立大學試點的。競爭名單是什麼樣的？你們是否正在與其他診斷、遠端診斷設備競爭？

Or did they have nothing before that?

還是他們之前什麼都沒有？

So the cancer center has not engaged with a digital health platform specific for cancer. I believe there are other products more that are being used broadly and they're actually in the process of trying to figure out what generalized remote patient monitoring platform they're going to use for the broader institution. But my understanding is this is the first foray of the cancer center, which is our direct partner in the digital health care platform arena. And certainly, our -- during the pilot, we were the only product that they were utilizing.

因此，癌症中心尚未建立專門針對癌症的數位健康平台。我相信還有其他產品正在被廣泛使用，他們實際上正在嘗試找出他們將用於更廣泛的機構的通用遠端患者監測平台。但我的理解是，這是癌症中心的首次嘗試，癌症中心是我們在數位醫療保健平台領域的直接合作夥伴。當然，在試點期間，我們是他們使用的唯一產品。

There are no further questions at this time. I would like to turn it back to Dr. Lishan Aklog for closing remarks.

目前沒有其他問題。我想請 Lishan Aklog 博士做結束語。

So great. Thank you, operator, and thank you all for joining today. I hope you leave today with a strong sense that PAVmed has taken the decisive steps that it needed to, to solidify and stabilize our corporate structure and strengthen our balance sheet. We really do look forward to a bright future, positioning PAVmed as a sustainable, diversified commercial life sciences company with multiply independently financed subsidiaries.

太棒了。謝謝運營商，也謝謝大家今天加入。我希望您今天離開時能夠強烈感受到 PAVmed 已採取必要的決定性步驟來鞏固和穩定我們的公司結構並加強我們的資產負債表。我們確實期待著光明的未來，將 PAVmed 定位為一家可持續發展、多元化的商業生命科學公司，擁有多個獨立融資的子公司。

I do encourage you to stay connected with our progress through our news releases, periodic calls such as this and signing up for e-mail alerts on our IR website, and you can also follow us on Twitter and LinkedIn. So again, thank you for your continued support. And as they say, watch this space. Have a great day.

我確實鼓勵您透過我們的新聞稿、定期電話會議以及在我們的 IR 網站上註冊電子郵件提醒來了解我們的進展，您也可以在 Twitter 和 LinkedIn 上關注我們。再次感謝您一直以來的支持。正如他們所說，請關注這個空間。祝你有美好的一天。

Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now disconnect.

謝謝。女士們、先生們，今天的電話會議到此結束。感謝大家的參與。您現在可以斷開連線。