PAVmed Inc (PAVM) 2024 Q4 法說會逐字稿

Good morning and welcome to PAVmed fourth-quarter 2024 business update conference call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Matt Riley, PAVmed's Senior Director of Investor Relations. Please go ahead.

早安，歡迎參加 PAVmed 2024 年第四季業務更新電話會議。（操作員指示）請注意，此事件正在被記錄。現在，我想將會議交給 PAVmed 投資者關係高級總監 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 disclosures 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.

宣布我們的業務更新和財務表現的新聞稿可在 PAVmed 的網站上查閱。請花一點時間閱讀新聞稿中有關前瞻性陳述的披露。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作的陳述有重大差異。

Factors that could cause actual results to differ are described in the disclaimer and in our filings with the SEC. 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 quarterly reports on Forms 10-Q and subsequent Forms 8-K.

可能導致實際結果不同的因素已在免責聲明和我們向美國證券交易委員會提交的文件中進行了描述。有關這些以及其他可能影響未來營運的重要風險和不確定性的清單和說明，請參閱 PAVmed 向美國證券交易委員會提交的最新 10-K 表格年度報告中的第一部分第 IA 項題為風險因素的內容，以及在 10-Q 表格和後續 8-K 表格季度報告中提交的任何後續內容。

Except as required by law, PAVmed disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes 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 不承擔公開更新或修改任何前瞻性陳述以反映變化的預期或事件、條件或情況（預期可能基於這些事件、條件或情況），或可能影響實際結果與前瞻性陳述中的結果不同的可能性的意圖或義務。

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

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

Thank you, Matt, and good morning, everyone. Thank you for joining our quarterly update call. I'd like to thank our long-term shareholders for your ongoing support and commitment.

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。我要感謝我們的長期股東一直以來的支持與承諾。

Before we delve into our recent operational highlights, I just want to reiterate some of the critical steps that we've taken to stabilize PAVmed's corporate structure and balance sheet. Those changes are now complete and PAVmed is now in a strong position to fulfill our mission.

在我們深入探討最近的營運亮點之前，我只想重申我們為穩定 PAVmed 的公司結構和資產負債表而採取的一些關鍵步驟。這些變革現已完成，PAVmed 現在有能力完成我們的使命。

As you know PAVmed, as the parent company has subsidiaries, including Lucid Diagnostics and various health and last year spinout as incubator PMX. As our subsidiaries succeed, particularly Lucid, it's important to understand that we expect PAVmed will follow suit and succeed as well.

如您所知，PAVmed 作為母公司擁有子公司，包括 Lucid Diagnostics 和各種健康公司，去年也分拆為孵化器 PMX。隨著我們的子公司（尤其是 Lucid）取得成功，重要的是要明白，我們預計 PAVmed 也將效仿並取得成功。

Beginning of this year, we successfully completed what was a carefully designed strategic transformation to solidify PAVmed as a sustainable vehicle. As you recall, last year, we completed the deconsolidation of Lucid Diagnostics and restructured our convertible debt.

今年年初，我們成功完成了精心設計的策略轉型，鞏固了 PAVmed 作為永續發展工具的地位。大家還記得，去年我們完成了 Lucid Diagnostics 的拆分並重組了我們的可轉換債務。

I disaccomplished two things. One is preserve PAVmed's ownership and Lucid without having to absorb Lucid's operating losses on its balance sheet and it allowed us to satisfy the Nasdaq minimum equity listing requirement.

我沒有完成兩件事。一是保留 PAVmed 和 Lucid 的所有權，而不必在 Lucid 的資產負債表上承擔其營運損失，這使我們能夠滿足納斯達克最低股權上市要求。

PAVmed is now well positioned to operate as designed as a diversified commercial life sciences company with multiple independently financed subsidiaries operating under a shared services model. So now on to highlights from the fourth quarter and recent weeks.

PAVmed 現已做好充分準備，按照設計營運成為一家多元化商業生命科學公司，擁有多家在共享服務模式下營運的獨立融資子公司。現在來看看第四季和最近幾週的亮點。

Let me start with Lucid Diagnostics; however, I do encourage you to listen to the Lucid business update call that from yesterday, for greater detail on these programs. But here are some of the main takeaways. Lucid generated $1.2 million in revenue and test volume of just over 4,000 tests, which represented a 45% growth quarter-on-quarter.

讓我從 Lucid Diagnostics 開始；不過，我確實鼓勵您聽聽昨天的 Lucid 業務更新電話會議，以了解有關這些計劃的更多詳細信息。但以下是一些主要要點。Lucid 的營收為 120 萬美元，測試量略高於 4,000 次，較上季成長 45%。

In the fourth quarter, EsoGuard revenue was approximately $1.2 million, and we booked record test volume of 4,042 tests, about 45% quarter-on-quarter. Growth above our targeted 2,500 to 3,000 tests per quarter that are necessary for us to achieve critical mass with our revenue cycle management and medical policy efforts while protecting our cash burn.

第四季度，EsoGuard 營收約為 120 萬美元，我們的測試量創下了 4,042 次測試的記錄，環比增長約 45%。成長幅度超過了我們每季 2,500 至 3,000 次測試的目標，這對於我們透過收入週期管理和醫療政策努力達到臨界規模同時保護我們的現金消耗是必要的。

Highmark Blue Cross Bar Shield in New York, established our first positive commercial insurance coverage policy for EsoGuard, so exciting development there. Another exciting development was the update to the National Comprehensive Cancer Network clinical practice guideline, which now includes esophageal pre-cancer screening, consistent with the ACG gastroenterology guidelines.

紐約的 Highmark Blue Cross Bar Shield 為 EsoGuard 制定了我們第一份積極的商業保險覆蓋政策，這是一個令人興奮的發展。另一個令人興奮的進展是國家綜合癌症網路臨床實踐指南的更新，現在包括食道癌前篩檢，與 ACG 胃腸病學指南一致。

As an important step, the NCCN is widely regarded as a key indicator of standards of excellence and we think this will help us drive positive commercial insurance coverage decisions in the coming quarters. Our concierge medicine cash pay program is off to a great start. We've executed over 20 concierge medicine contracts in just a few weeks since we started this program.

作為重要的一步，NCCN 被廣泛視為卓越標準的關鍵指標，我們認為這將有助於我們在未來幾季推動積極的商業保險覆蓋決策。我們的禮賓醫療現金支付計劃開局良好。自從啟動該計劃以來，我們在短短幾週內就簽訂了 20 多份禮賓醫療合約。

We also strengthened our balance sheet with long term debt refinancing and a registered direct common stock offering, extending our cash runway past the key upcoming reimbursement milestones. We're also waiting for a response to our submission to the MolDX Group for reconsideration of EsoGuard for Medicare coverage under the existing local coverage determination that was submitted in November, and we expect some action on that and remain optimistic for action within the first half of this year.

我們也透過長期債務再融資和註冊直接普通股發行加強了我們的資產負債表，將我們的現金流量延長至即將到來的關鍵償還里程碑之後。我們也正在等待對我們於 11 月提交給 MolDX 集團的回复，該回复要求重新考慮根據現有的當地覆蓋範圍決定是否將 EsoGuard 納入醫療保險覆蓋範圍，我們預計將會採取一些行動，並且對今年上半年採取行動持樂觀態度。

Also a lot of great progress with Veris Health. We were excited to complete a private placement financing with gross proceeds of $2.4 million at a $35 million pre-money evaluation. These were credit investors who purchased PAVmed's Securities at the market as well as shares of Veris common stock.

Veris Health 也取得了很大進展。我們很高興完成了私募融資，總收益為 240 萬美元，投資前估值為 3,500 萬美元。這些是信貸投資者，他們在市場上購買了 PAVmed 的證券以及 Veris 普通股。

This financing supplements recently secured $1.8 million nondilutive two year NIH grant. The financing allows us to advance our strategy. We're focusing on the completion of the regulatory process for the implantable physiologic monitor and a regulatory clearance regulatory submission by the end of this year or into the first quarter of next year.

這項融資補充最近獲得了 180 萬美元的非稀釋性兩年 NIH 撥款。這筆融資使我們能夠推進我們的策略。我們的目標是在今年年底或明年第一季完成植入式生理監測器的監管流程和監管許可監管提交。

We believe that this Veris pre-money valuation really reflects strong investor confidence in Veris' long-term commercial potential. And we expect that once cleared the implantable monitor will significantly enhance the commercial potential.

我們相信，Veris 的投資前估值確實反映了投資者對 Veris 長期商業潛力的強烈信心。我們預計，一旦該植入式監測器被批准，其商業潛力將大大增強。

We also continue to have a strong engagement with our partners at The Ohio State University, the James Cancer Center. We extended our pilot program with them to the end of April to give us time to close our long term commercial and strategic partnership, which we believe is imminent.

我們也繼續與俄亥俄州立大學詹姆斯癌症中心的合作夥伴保持密切合作。我們將與他們的試點計畫延長至 4 月底，以便我們有時間完成長期商業和策略合作夥伴關係，我們相信這即將到來。

On the incubator side, we're continuing to seek direct financing to fund the portion effect contact with angel investors as well as with several strategics, and those conversations remain active.

在孵化器方面，我們正在繼續尋求直接融資，以資助與天使投資者以及幾項策略的部分效果聯繫，並且這些對話仍然活躍。

With that, I'll pass the call on to Dennis.

說完，我就把電話轉給丹尼斯。

Thanks, Lishan, and good morning, everyone. Our summary financial results for the fourth quarter and the year were reported in our press release that has been distributed. On the next three slides, I'll emphasize a few key highlights from the fourth quarter, but I encourage you to consider those remarks in the context of the full disclosures covenant in our annual report on Form 10-K as filed with the SEC.

謝謝李山，大家早安。我們已在已發布的新聞稿中報告了第四季度和全年的財務業績摘要。在接下來的三張幻燈片中，我將強調第四季度的一些關鍵亮點，但我鼓勵您在我們向美國證券交易委員會提交的 10-K 表格年度報告中的全面披露契約的背景下考慮這些言論。

With regard to the balance sheet, you will recall from our last call in November, the company was engaged in a multistep process to regain compliance with Nasdaq listing standard for minimum equity and also position the company for long term financial stability.

關於資產負債表，您會記得我們 11 月的上次電話會議，該公司正在進行一個多步驟的流程，以重新符合納斯達克上市最低股權標準，並為公司的長期財務穩定做好準備。

Among the strategic endeavors that Lishan spoke about, there are three immediate tactical financial targets, we were intent on accomplishing namely, one, deconsolidating Lucid from PAVmed's consolidated financial statements; two, restructuring our debt from free, focusing on financing Veris and PortIO.

在李山談到的戰略努力中，有三個直接的戰術財務目標，我們打算實現，即：一、將 Lucid 從 PAVmed 的合併財務報表中分離出來；二、免費重組我們的債務，重點為 Veris 和 PortIO 提供融資。

This slide reflects the balance sheet for the third quarter and fourth quarter after deconsolidation, which occurred on September 10. But prior to the effect of the debt exchange, which became effective on January 17, 2025, right after the shareholders approved the exchange; and two, prior to Nasdaq's notice of listing compliance on February 14; and three, prior to the PAVmed Veris financing that occurred on February 21.

此投影片反映了 9 月 10 日脫離合併後的第三季和第四季的資產負債表。但在債務交換生效之前，債務交換於 2025 年 1 月 17 日生效，即股東批准交換之後；二是2月14日納斯達克發佈上市合規通知之前；三是在 2 月 21 日 PAVmed Veris 融資之前。

So a couple of key things to point out on each of these balance sheets. Cash does not include any Lucid cash. Two, the equity method investment balances reflect the $31.3 million Lucid shares mark-to-market on each balance sheet date, which is December 31, the date of the balance sheet was $0.82 per share.

因此，在每張資產負債表上需要指出幾個關鍵點。現金不包括任何 Lucid 現金。二、權益法投資餘額反映了每個資產負債表日（即 12 月 31 日）以市價計價的 3,130 萬美元 Lucid 股票，資產負債表日的市價為每股 0.82 美元。

This amount was previously eliminated from PAVmed's balance sheet prior to deconsolidation. The stock price between September 30 and December 31, was relatively flat. Hence, the balance did not change much between the beginning and ending dates of the fourth quarter.

在拆分之前，該金額已從 PAVmed 的資產負債表中消除。9月30日至12月31日期間，股價相對穩定。因此，第四季開始和結束之間的餘額並沒有太大變化。

However, the Lucid stock price is way up since year-end, and so the impact of a rising stock price can have a dramatic impact on PAVmed's first quarter results. A way to think about that impact of this line item and how it affects the building financial stability of PAVmed is as follows.

然而，Lucid 股價自年底以來一路上漲，因此股價上漲的影響可能會對 PAVmed 第一季的業績產生巨大影響。思考此項的影響以及它如何影響 PAVmed 的財務穩定性的方法如下。

For every $0.032 of Lucid price change from a base of $0.82, the balance sheet amount will change by $1 million in total. As an example, just in the last couple of weeks, this amount has increased to just under $50 million.

Lucid 價格每從 0.82 美元的基數變動 0.032 美元，資產負債表金額就會總共變動 100 萬美元。例如，僅在過去幾週，這筆金額就已增加至近 5,000 萬美元。

Note, there is plenty more information in the 10-K on this topic, particularly note four to the financial statements. The senior secured note balances are before the debt exchange that occurred after year-end on January 17.

請注意，10-K 中還有更多關於此主題的信息，特別是財務報表的第四條註釋。優先擔保票據餘額是在 1 月 17 日年末之後發生的債務交換之前的。

A general way to think about how the balance sheet amount changes as a result of the January debt exchange is to decrease the debt by $25 million and increased preferred equity by $25 million. PAVmed continues to be the single largest shareholder of the common stock.

思考一月份債務交換導致的資產負債表金額變化的一般方法是減少 2500 萬美元的債務並增加 2500 萬美元的優先股。PAVmed 繼續成為普通股的最大單一股東。

However, the controlling voting interest dropped from more than 50% to about 32%, as a result of these intentional actions by management and the Board clearing the pathway to deconsolidate Lucid from PAVmed.

然而，由於管理層和董事會採取這些有意的行動，為將 Lucid 從 PAVmed 分離出來掃清了道路，控股投票權從 50% 以上下降到 32% 左右。

Some additional tactical steps that have been taken by management and the Board. One, the incurs the future R&D expenses to advance the next development stages of the Veris cancer care platform and PorIO technology will be largely dependent upon obtaining funding for those entities to cover the incremental development costs.

管理階層和董事會已採取一些額外的策略措施。一是，推動 Veris 癌症護理平台和 PorIO 技術的下一階段開發所需的未來研發費用將在很大程度上取決於這些實體是否能獲得資金來支付增量開發成本。

Hence, any increased burn rate from those endeavors will be offset from the incremental financing. As a good start in that direction, we previously announced being awarded an NIH grant of $1.8 million for Veris. It's payable over two years, for which we collected 50% of the award in December, which covered Veris expenses in the fourth quarter.

因此，這些努力所增加的任何燒錢率都將被增量融資所抵消。作為朝這個方向邁出的良好一步，我們先前宣布獲得 NIH 為 Veris 提供的 180 萬美元資助。該獎金分兩年支付，我們在 12 月收到了 50% 的獎金，涵蓋了 Veris 在第四季度的開支。

The additional funding efforts have been -- were paused pending the outcome of the Nasdaq Hearings Panel. With the Nasdaq approval in hand on February 14, the PAVmed's Veris financing was then later completed on February 21. The Veris component of the financing was negotiated a $35 million pre-money value.

由於納斯達克聽證小組的結果尚未公佈，額外的融資努力已經暫停。隨著 2 月 14 日獲得納斯達克批准，PAVmed 的 Veris 融資隨後於 2 月 21 日完成。此次融資中 Veris 部分的談判前價值為 3,500 萬美元。

PortIO Corp. has ongoing discussions with both financial and strategic investors for a direct investment in the PortIO Corp at a pre-money valuation of $42 million to cover the final development costs. Shares outstanding today include unvested RSAs at approximately 17.5 million shares outstanding.

PortIO Corp. 正在與金融和策略投資者進行商談，以 4,200 萬美元的投資前估值對 PortIO Corp 進行直接投資，以支付最終開發成本。今日流通股包括未歸屬的 RSA，流通股數約為 1,750 萬股。

The GAAP year-end outstanding shares of $11.2 million are reflected on the slide as well as on the face of the balance sheet in the 10-K. GAAP shares do not reflect unvested RSA amounts.

以 GAAP 計算的年末流通股數為 1,120 萬美元，這在 10-K 報表的幻燈片和資產負債表中均有體現。GAAP 股票不反映未歸屬的 RSA 金額。

Next slide, please. Similar to past presentations, this P&L slide provides some GAAP and non-GAAP year-over-year quarterly and annual comparisons. 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.

請看下一張投影片。與過去的簡報類似，此損益表幻燈片提供了一些 GAAP 和非 GAAP 同比季度和年度比較。然而，鑑於 PAVmed 對 Lucid 的財務控制發生變化，比較期間的資訊彙編方式存在一些顯著差異。

Importantly, the GAAP construct for deconsolidating Lucid on September 10 somewhat blurs the historical understanding of the information for PAVmed as a standalone entity and GAAP does not allow the presentation for prior periods to be similarly adjusted.

重要的是，9 月 10 日脫離 Lucid 的 GAAP 構造在某種程度上模糊了對 PAVmed 作為獨立實體的資訊的歷史理解，並且 GAAP 不允許對前期的呈現進行類似的調整。

The GAAP annual results as presented reflect inclusion or consolidation of Lucid's results through September 10, and then differently after that date, mainly without Lucid's results. Furthermore, you will see a large net income of $28.4 million on the GAAP P&L before non-controlling interest.

所呈現的 GAAP 年度業績反映了截至 9 月 10 日 Lucid 業績的納入或合併，而該日期之後的業績則有所不同，主要不包括 Lucid 的業績。此外，您還會在 GAAP 損益表中看到非控制權益前的淨收入高達 2,840 萬美元。

And the 10-K shows a GAAP positive primary EPS of $3.30 per share and a positive diluted EPS of $0.50 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.

10-K 顯示 GAAP 正主要每股收益為 3.30 美元，每股稀釋每股收益為 0.50 美元。這都是將 Lucid 從 PAVmed 的資產負債表中剔除，並提取 Lucid 累積歷史損失的影響的結果。

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 the deconsolidation adjustments. Happy to answer any detailed questions on the slide in the Q&A.

資產負債表的淨調整產生了 7,200 萬美元的收益，然後該收益流入損益表以獲得所有拆分調整的淨權益影響。很高興回答問答環節中有關幻燈片的任何詳細問題。

But I think it's more informative to look at the fourth quarter standalone information presented in the slide and the full fourth quarter information presented in our press release that shows a company baseline bias of operating at cash flow breakeven, incurring incremental pad net expenses for development activities that are offset by dedicated funding.

但我認為，查看幻燈片中提供的第四季度獨立資訊和新聞稿中提供的完整第四季度資訊會更有參考價值，這些資訊表明公司基線偏差是在現金流盈虧平衡的情況下運營，產生了由專用資金抵消的開發活動增量墊淨費用。

So in the fourth quarter, you see a non-GAAP loss of $688,000, which has been offset by the NIH grant proceeds of $900,000. Where that three months ended December 31, 2024, PAVmed revenues reflect approximately 125 patients on the Veris Cancer Care platform largely in connection with the expanded pilot program with OSU.

因此，在第四季度，您會看到非 GAAP 虧損 688,000 美元，但這筆虧損已被 NIH 撥款收益 900,000 美元所抵消。截至 2024 年 12 月 31 日的三個月，PAVmed 的收入反映了 Veris Cancer Care 平台上約 125 名患者，這主要與俄勒岡州立大學擴大的試點計畫有關。

EsoGuard related revenues are no longer consolidated with PAVmed results with a deconsolidation that became effective in September. PAVmed's management service income from Lucid diagnostics of $3.2 million for the quarter is reflected in other income.

EsoGuard 相關收入不再與 PAVmed 業績合併，合併從 9 月開始生效。PAVmed 本季從 Lucid Diagnostics 獲得的管理服務收入為 320 萬美元，反映在其他收入中。

Operating expenses were approximately $5.2 million which includes stock based compensation expenses of $700,000. GAAP net income attributable to common stockholders was approximately $1.3 million or approximately $0.12 per common share on a diluted basis for the quarter. Next slide, please.

營運費用約為 520 萬美元，其中包括 70 萬美元的股票薪酬費用。本季歸屬於普通股股東的 GAAP 淨收入約為 130 萬美元，或每股普通股攤薄收益約為 0.12 美元。請看下一張投影片。

With regard to the non-GAAP operating expenses on this slide, you'll see a graphic illustration of our operating expenses over time as presented in more detail in our press release. Total non-GAAP OpEx is $4.2 million for the fourth quarter of '24.

關於此投影片中的非 GAAP 營運費用，您將看到我們隨時間變化的營運費用的圖形說明，如我們的新聞稿中更詳細地介紹的那樣。24 年第四季非公認會計準則營運支出總額為 420 萬美元。

The decrease is equally related to the impact of deconsolidation and the fact that the combined OpEx ignoring deconsolidation of PAVmed and Lucid would have been in line with the previous quarters. With that, operator, let's open it up for questions.

這一下降同樣與拆分的影響有關，而且忽略 PAVmed 和 Lucid 拆分後的合併營運支出與前幾季持平。接線員，好了，讓我們開始提問。

(Operator Instructions) Jeremy Pearlman, Maxim Group.

（操作員指示）傑里米·珀爾曼（Jeremy Pearlman），馬克西姆集團（Maxim Group）。

Jeremy, good morning.

傑里米，早安。

Good morning.

早安.

Good morning. Yeah, thank you for taking my question. Just quickly on the Veris Health Care Cancer platform with the Ohio State pilot program. So it seems like it was extended through April. It seems like the finalizing the contract. I mean, what is -- based on your conversations you're having with them, what does that contract do you think look like? How is it going to play out.

早安.是的，感謝您回答我的問題。只需快速瀏覽俄亥俄州試點計劃中的 Veris Health Care Cancer 平台即可。因此看起來它已經延長到四月了。看起來就像是敲定合約一樣。我的意思是——根據您與他們的談話，您認為合約是什麼樣的？事情將會如何發展呢？

Yeah, it's really exciting because it's not only a commercial engagement in our first major commercial engagement. It will be our first major commercial engagement with the third largest cancer center in the country.

是的，這真的令人興奮，因為這不僅是我們第一次重大商業合作。這將是我們與全國第三大癌症中心的首次重大商業合作。

It's also a strategic partnership, and that's been part of the nature of our engagement with Ohio State with the James Cancer Center going back to the very beginning and the contemplation of the memorandum of understanding, the design and the launch of the pilot program, the sort of joint assessment of the successes of the pilot program with regard to the various key performance indicators, KPIs as well as clinical success, fine tuning to how the platform works within the construct of their workflow.

這也是一種策略合作夥伴關係，也是我們與俄亥俄州立大學和詹姆斯癌症中心合作的性質的一部分，可以追溯到最初，包括對諒解備忘錄的考慮、試點計畫的設計和啟動、對試點計畫在各種關鍵績效指標、關鍵績效指標以及臨床成功方面的成功進行聯合評估，以及對平台在其工作流程中的運作方式進行微調。

And so all of that's been great. So the reason we extended the pilot was, frankly, because as we were working through the details of what the agreement would look like the -- there was just demand from the clinical sites to continue on patients.

所以這一切都很棒。所以坦白說，我們延長試點的原因是，當我們在研究協議的細節時——臨床站點有繼續對患者進行治療的需求。

And so we just agreed to continue it while we are ironing out the final details. there will be a commitment from Ohio State to enroll a substantial portion of patients over the first year. These will be commercial patients, but also patients enrolled in a registry.

因此，我們同意在敲定最後細節的同時繼續進行。俄亥俄州立大學承諾在第一年內招募大量患者。這些人將是商業患者，也是登記在冊的患者。

So we'll be able to use that data, collect that data for ongoing improvements, but also for a pathway towards data analytics and development of clinical section support tools using AI. They have also committed to being the first site once the agreement is consummated for them to be the first site for the initial implantation of the implantable device once it's FDA cleared and to do a separate registry for that to help us document its role on and to use.

因此，我們將能夠使用這些數據，收集這些數據以進行持續改進，同時也為使用人工智慧進行數據分析和開發臨床科室支援工具開闢道路。他們還承諾，一旦協議達成，他們將成為第一個植入式設備獲得 FDA 批准後進行首次植入的場所，並為此進行單獨的註冊，以幫助我們記錄其作用和使用情況。

That's really a comprehensive commercial as well as strategic partnerships. What it does during this interval of time were -- where the primary focus for Veris is going to be on advancing the implantable and launching the agreement with Ohio State.

這確實是一個全面的商業和策略合作夥伴關係。在此期間，Veris 的主要工作重點是推進植入式技術以及與俄亥俄州立大學達成協議。

What it will do for us as we culminate that process, and we end up crossing the threshold with FDA clearance is it will really be a poster child, a standard bearer for our ability to engage with other large cancer centers. And the James is very committed to helping us do that and for them to be at the forefront of using a dedicated cancer care platform to enhance the care of their patients.

當我們完成這個過程，並最終跨越 FDA 批准的門檻時，它將為我們帶來真正的典範，成為我們與其他大型癌症中心合作能力的旗手。詹姆斯非常致力於幫助我們做到這一點，並讓他們走在使用專門的癌症護理平台來加強對患者的護理的前沿。

Understood, thank you. And then just one follow-up question. You mentioned the implantable device. Now that you have funding for that. Do you have any more clarity how that time line would look until you hopefully get potential FDA approval for that?

明白了，謝謝。然後只有一個後續問題。您提到了植入式裝置。現在您已經有資金了。在獲得 FDA 批准之前，您是否更清楚地了解時間表是怎樣的？

Yeah, sure. So we're getting the manufacturing partners with us back online and getting all the -- as you may recall, we are pretty far along with that process. And so that's just -- that's all getting rebooted. Right now, it looks like that process will be completed and will be ready for submission in the very end of this year or the early part of 2026.

是的，當然。因此，我們正在讓製造合作夥伴重新上線並獲得所有 - 您可能還記得，我們​​在這個過程中已經取得了很大進展。所以這只是——一切都將重新啟動。目前看來，該流程將在今年年底或 2026 年初完成並準備提交。

The -- I just want to maybe use this opportunity to note that we've had numerous engagements, pre-submission meetings with the FDA. We have a very clear idea. They have a very clear idea of what we intend to do, and we have a very clear idea of what they're going to ask us to do.

我只是想藉此機會指出，我們已經與 FDA 進行了多次接觸和提交前會議。我們有一個非常明確的想法。他們非常清楚我們打算做什麼，我們也非常清楚他們要我們做什麼。

It's been a very successful engagement, and that it looks like we'll be able to avoid having to do any kind of sort of meaningful human clinical trial of the implantable where it's actually implanted and we're in the final stages of kind of just checking one last box with them around the way to validate a skin study where the device is just put on the skin and used to monitor patients for short periods of time to demonstrate that -- to demonstrate its efficacy without having to do a full blown clinical study. So really intend to engage with FDA that's really born fruit with regard to what we'll have to do to get this thing cleared.

這是一次非常成功的合作，看起來我們將能夠避免進行任何有意義的人體臨床試驗，在實際植入的情況下，我們正處於最後階段，只需與他們一起檢查最後一個方框，以驗證皮膚研究，其中設備只需放在皮膚上並用於短時間監測患者以證明 - 無需進行全面的臨床研究即可證明其功效。因此，我們確實打算與 FDA 合作，就我們需要採取哪些措施來解決這個問題而言，這確實取得了成果。

Okay, great. Thank you for that information, and I'll hop back in the queue.

好的，太好了。謝謝您提供的信息，我會重新回到隊列中。

Great, thanks, Jeremy.

太好了，謝謝，傑里米。

Ross Osborn, Cantor Fitzgerald.

羅斯奧斯本、康托費茲傑拉。

Hi Ross. How are you?

你好，羅斯。你好嗎？

Hey guys, this is Matthew Park on for Ross today. Thanks for taking my questions. I guess just one for me. Can you give us some color on the discussions you're having with other institutions on Veris to initiate pilot launches and any learnings you can take from what you're doing at OSU, when going into other centers?

大家好，今天我是馬修·帕克 (Matthew Park)，為羅斯主持節目。感謝您回答我的問題。我想對我來說只有一個。您能否向我們介紹一下您與其他機構就 Veris 啟動試點計畫進行的討論情況，以及您在俄勒岡州立大學開展工作時可以學到哪些經驗，以便將其推廣到其他中心？

Yeah, so we had a pretty comprehensive process screening the sort of hundreds of cancer centers in this country, screening for targets that are -- that have NCI designation that have -- that are large, have significant number of patients getting advanced therapies. And I would say of that group, we've had meaningful conversations with about a dozen or so and more advanced conversations with enhanceable four or five of those.

是的，我們對全國數百家癌症中心進行了非常全面的篩檢，篩選出那些獲得 NCI 認證、規模較大、有大量患者接受先進治療的目標中心。我想說的是，在這個群體中，我們與大約十幾個人進行了有意義的對話，並與其中四、五個人進行了更高級的對話。

We're not pushing real hard on advancing new pilots because we want to take the sort of limited resources right now and make sure that we're advancing the -- that we're applying those the implantable. We really believe from the pilot engagement with OSU, that although we've had really great success with the software platform in conjunction with the various box of connected devices that the real differentiator here over the medium and long term is with the implantable.

我們並沒有真正大力推進新的試點項目，因為我們希望利用目前有限的資源，確保我們正在推進——我們正在應用這些可植入技術。我們確實相信，從與俄勒岡州立大學的試點合作來看，儘管我們在軟體平台與各種連接設備的結合上取得了巨大的成功，但從中長期來看，真正的區別在於植入式設備。

So we continue to have dialogues with a handful of other major centers. There's been positive feedback with regard to our experience to date with Ohio State and the opportunity to enhance care. So those relationships are being kept warm.

因此，我們繼續與其他幾個主要中心進行對話。關於我們迄今為止與俄亥俄州立大學合作的經驗以及加強護理的機會，我們得到了積極的回饋。因此這些關係一直保持著熱絡。

It's certainly possible we'll add a pilot or two during this period where we're focused primarily on the OSU engagement and the advancement of the implantable, but we don't expect to make a major push to expand the number of sites until after the implantable is clear.

在此期間，我們當然有可能增加一兩個試點，主要關注俄勒岡州立大學的參與和植入式技術的進步，但我們預計在植入式技術明確之前不會大力擴大站點數量。

And we believe that that's the best utilization of our resources. And frankly, by then, we'll have a meaningful amount of data from the more formal post-pilot commercial engagement with OSU that we'll be able to leverage. There are also a variety of other things that we're going to be working on over -- during this period of time.

我們相信這是對我們資源的最佳利用。坦白說，到那時，我們將從與俄勒岡州立大學更正式的試點後商業合作中獲得大量有意義的數據，我們將能夠利用這些數據。在此期間，我們還將進行許多其他工作。

We're looking to work with OSU on helping us develop the clinical support offering, so we can offer sites the ability for Veris personnel to provide some clinical support to triage alerts and so forth to help them make maximally utilize the platform itself. So that's something that's in progress as well as developing tools beyond the baseline remote patient monitoring functionality that already exists.

我們希望與俄勒岡州立大學合作，幫助我們開發臨床支援服務，這樣我們就可以為站點提供 Veris 人員提供一些臨床支援來分類警報等，以幫助他們最大限度地利用平臺本身。因此，這是正在進行的工作，同時也正在開發超越現有的遠端病人監控基線功能的工具。

So AI-based tools for clinical decision support. So all of those are really things that will enhance the product both the implantable as well as the software element, which will put us in a strong position to expand beyond a handful of centers once the implantable is cleared.

因此，基於人工智慧的工具可用於臨床決策支援。因此，所有這些都將真正增強產品的可植入性和軟體元素，一旦可植入性獲得批准，這將使我們處於有利地位，並能夠擴展到少數幾個中心之外。

Got it. Super helpful makes sense. And then I guess one more for me on PortIO. So pending any incremental financing, can you just walk us through what the path to FDA approval would look like here? And any additional studies you need to go through?

知道了。超級有幫助，很有意義。然後我想在 PortIO 上再寫一個。因此，在等待任何增量融資的情況下，您能否向我們介紹一下獲得 FDA 批准的途徑是怎樣的？您還需要進行其他研究嗎？

Thanks. Sure. We don't have to talk too much, but just maybe as on PortIO, so just a reminder of what PortIO actually is. PortIO is the first implantable long term vascular access device that uses the bone marrow at a site. That's the intraosseous or IO portion of the name PortIO.

謝謝。當然。我們不需要說太多，但也許就像在 PortIO 上一樣，只是提醒一下 PortIO 實際上是什麼。PortIO 是第一個利用局部骨髓的可植入長期血管通路裝置。這是 PortIO 名稱中的骨內或 IO 部分。

And it's usually going to provide really an opportunity to provide long term vascular access for patients who have poor veins, for patients who need their veins for future dialysis and a variety of other very large market opportunities that total about $2 billion.

它通常會為靜脈狀況較差的患者、需要靜脈進行未來透析的患者提供長期血管通路的機會，以及其他各種總額約 20 億美元的非常大的市場機會。

So to get more directly to your question, the pathway is quite straightforward. PAVmed has already invested a substantial amount in getting the getting the device through the first -- the Gen1 device through verification and validation testing.

因此，為了更直接地回答您的問題，途徑非常簡單。PAVmed 已經投入了大量資金來使該設備通過第一次驗證和確認測試——Gen1 設備。

And if you recall, we completed a successful first-in-human study in Colombia, South America, that went perfectly. Excellent results of online patients. It worked exactly as intended and that's the basis for our discussions with FDA on what a IDE would look like.

如果你還記得的話，我們在南美洲的哥倫比亞成功完成了一項首次人體研究，一切都很順利。線上患者療效極佳。它完全按照預期運行，這也是我們與 FDA 討論 IDE 的基礎。

The regulatory path here is a de novo, but a fairly straightforward de novo, as de novo because this is a new category of device. There's never ever been a device that can use the intraosseous for long term use. The plan upon securing the financing either through investors or through what are fairly active discussions right now with the strategics in the space would be to launch the IDE study.

這裡的監管路徑是全新的，但是一個非常簡單的全新，之所以稱之為全新，是因為這是一個新類別的設備。從來沒有一種設備可以長期使用骨內裝置。該計劃將在透過投資者或目前與該領域策略界相當活躍的討論獲得融資後啟動 IDE 研究。

We estimate the number of patients in that study on the low end of the sort of 50 to 80 patient range. And so that we believe we could enroll somewhere in the 18 month period, perhaps less, perhaps a bit longer depending on the site that we secure. So that will get us through FDA -- completing that study will allow us to submit and secure clearance with FDA.

我們估計研究中的患者人數在 50 至 80 人之間。因此，我們相信我們可以在 18 個月的時間內招募到人才，也許更短，也許更長，這取決於我們所保護的地點。這樣我們就能通過 FDA 審核——完成這項研究後我們就能向 FDA 提交申請並獲得批准。

Certainly, our goal would be within two years of the launch show the clinical study, hopefully or possibly less than that. In parallel, we've made significant progress on the Gen 2 device that has the same basic core element.

當然，我們的目標是在推出後的兩年內展示臨床研究，希望或可能更短。同時，我們在具有相同基本核心元素的第二代設備上取得了重大進展。

It had some improvements with regard to the silicon septum and some of the ergonomics of the delivery device. We will also use a portion of the capital raised to advance the Gen 2 device in parallel and frankly, just swap it out in the middle of the study using the appropriate mechanisms that FDA allows for that, so that the commercial launch would be with the Gen 2 device.

它對矽膠隔膜和輸送裝置的人體工學進行了一些改進。我們還將使用籌集到的部分資金來同時推進 Gen 2 設備的研發，坦白說，只需在研究過程中使用 FDA 允許的適當機制將其替換掉，這樣就可以使用 Gen 2 設備進行商業發布。

Got it. That makes sense. Thanks for taking the questions guys.

知道了。這很有道理。謝謝大家回答這些問題。

Yeah, great, thanks a lot. Appreciate it.

是的，太好了，非常感謝。非常感謝。

Ed Woo, Ascendiant Capital.

Ed Woo，Ascendiant Capital。

Yeah, congratulations on all the progress. My question is on Veris. As you're possibly talking to other cancer centers, have you run into any competing products or competition out there?

是的，祝賀你取得的所有進展。我的問題是關於 Veris 的。由於您可能正在與其他癌症中心交談，您是否遇到任何競爭產品或競爭對手？

Yeah, great question. So the competitive landscape here is very attractive in a variety of ways. So let's just start at the highest level. Yeah, there is a fair number of companies that offer rather generic remote patient monitoring software tools that just allow you to track patients in a very generic way.

是的，很好的問題。因此，這裡的競爭格局在許多方面都非常有吸引力。因此，讓我們從最高級別開始。是的，有相當多的公司提供相當通用的遠端病人監控軟體工具，這些工具只能讓你以非常通用的方式追蹤病人。

So it gives me an opportunity to remind you and others that what's great about the software platform Veris software platform is designed from the bottom up by oncologists to be very specific to patients undergoing systemic therapy, chemotherapy immunotherapy for cancer.

因此，它給了我一個機會來提醒您和其他人，軟體平台的優點在於 Veris 軟體平台是由腫瘤學家自下而上設計的，非常適合接受全身治療、化療和癌症免疫治療的患者。

What does that actually mean in practice? It means that the patient -- the part that interfaces with patients and ask them about their symptoms and so forth is very highly tuned to what cancer patients are undergoing.

這在實踐中究竟意味著什麼？這意味著患者——與患者接觸並詢問他們的症狀等的部分非常了解癌症患者正在經歷的情況。

So that's one differentiating factor compared to just traditional remote patient monitoring RPM technologies that are used sort of across the board across patients with chronic disease, acute disease and so forth. So there's really nothing out there that is competitive with regard to targeting cancer patients.

因此，與傳統的遠距病人監測 RPM 技術相比，這是一個區別因素，後者廣泛應用於慢性病、急性病等患者。因此，就針對癌症患者而言，實際上沒有任何產品具有競爭力。

Perhaps even more important over the long term or not even that much of a long term because we're not that far from having the implantable is the implantable. That's a proprietary technology patent protected that will be a barrier to entry for others trying to get in this space.

從長遠來看，這也許更為重要，或者說，從長遠來看，這也許並不重要，因為我們距離植入物並不遙遠。這是一項受保護的專有技術專利，它將成為其他試圖進入該領域的人的進入障礙。

So we believe certainly, right now, we have the only dedicated product that's really of interest. I'll note that I'm not just saying that, we participated in a -- Veris participated in a medical center wide RFP, request for proposals with OSU and we were able to secure approval for the Veris platform to be the dedicated platform for their cancer center.

因此我們相信，目前我們擁有唯一真正令人感興趣的專用產品。我要指出的是，我不僅僅是說說而已，我們參與了——Veris 參與了醫療中心範圍的 RFP，向俄勒岡州立大學徵求建議書，並且我們能夠獲得批准，將 Veris 平台作為其癌症中心的專用平台。

There really wasn't any meaningful competition in that exercise. Once we have the implantable, that really is the moat, that's the significant value added and it's a barrier to entry for others trying to get into the space.

那次演習其實並沒有任何有意義的競爭。一旦我們有了可植入技術，它就真的成了護城河，帶來了顯著的附加價值，也為其他試圖進入該領域的公司設置了進入障礙。

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

偉大的。好吧，謝謝你回答我的問題。祝你們好運。謝謝。

Yeah, thanks a lot Ed.

是的，非常感謝 Ed。

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

我目前沒有其他問題。我想請 Lishan Aklog 博士做最後發言。

Great. Thank you, operator, and thank you all for joining us today. Hopefully, it's clear from our comments here that with the various challenges over the past year now really squarely behind us and PAVmed on a very strong footing.

偉大的。謝謝接線員，也謝謝大家今天加入我們。希望從我們的評論中可以清楚地看出，過去一年來的各種挑戰現在已經完全過去，PAVmed 的基礎非常穩固。

Our team is really looking forward to a very strong remainder of 2025. Lucid is making really strong progress on multiple fronts. We believe we're on the cusp of the major inflection milestones that will drive shareholder value. And the work we've done over the last six months on the PAVmed restructure will really allow PAVmed to directly benefit from the Lucid value creation side.

我們的團隊真誠期待 2025 年剩餘時間的出色表現。Lucid 在許多方面都取得了長足的進步。我們相信，我們正處於推動股東價值成長的重大轉折點的尖端。我們在過去六個月中為 PAVmed 重組所做的工作將真正使 PAVmed 直接從 Lucid 價值創造方面受益。

And as you've heard, including during the Q&A period here, Veris is also in a much stronger position. We've demonstrated that it's financeable. It's been able to raise sufficient capital to advance its key asset, which is the implantable monitor.

正如您所聽到的，包括在問答環節中，Veris 也處於更有利的地位。我們已經證明它是可融資的。它已經能夠籌集足夠的資金來推進其關鍵資產，即植入式監視器。

And we're on the verge of launching our first strategic and commercial engagement with a major academic center, which really bodes well for the long term commercial success. This stability, we haven't really talked about it much today. We've touched on it before also allows PAVmed to continue to pursue other assets in the broader life sciences sector to drive value, and that's an active process that we're continuing.

我們即將與一家大型學術中心進行首次策略和商業合作，這對長期的商業成功來說確實是一個好兆頭。關於這種穩定性，我們今天實際上並沒有談論太多。我們之前曾提到過，這也使得 PAVmed 能夠繼續在更廣泛的生命科學領域尋求其他資產來推動價值，而這是我們正在繼續的積極過程。

So with that said, I do encourage you to stay connected with our progress, our news releases, these calls as well as signing up for our e-mail alerts from our website, and you can also follow us on Twitter and LinkedIn. So thank you, everybody, and have a great day.

因此，我確實鼓勵您關注我們的進展、我們的新聞稿、這些電話以及從我們的網站註冊我們的電子郵件提醒，您也可以在 Twitter 和 LinkedIn 上關注我們。謝謝大家，祝大家有個愉快的一天。

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

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