Insight Molecular Diagnostics Inc (IMDX) 2024 Q3 法說會逐字稿

Thank you for standing by. My name is Kayla, and I will be your conference operator today.

感謝您的支持。我叫凱拉，今天我將擔任您的會議主持人。

(Operator Instructions)

（操作員指令）

I would now like to turn the call over to Julie Silber from PCG Advisory. Please go ahead.

現在我想將電話轉給 PCG Advisory 的 Julie Silber。請繼續。

Thank you, Kayla, and thank you to everyone for joining us for today's conference call to discuss OncoCyte's third quarter 2024 financial results and recent operating highlights. If you have not seen today's shareholder letter, please visit OncoCyte's Investor Relations page at investors.oncocyte.com to read it.

謝謝 Kayla，也謝謝大家參加今天的電話會議，討論 OncoCyte 2024 年第三季的財務表現和近期營運亮點。如果您還沒有看到今天的股東信，請訪問 OncoCyte 的投資者關係頁面 investors.oncocyte.com 閱讀。

Today's prepared remarks build upon the information that was already shared in this robust letter. On today's call is OncoCyte's President and CEO, Josh Riggs; Chief Science Officer, Ekke Schutz; and CFO, Andrea James.

今天的準備好的發言以這封有力的信函中已經分享的信息為基礎。參加今天電話會議的有 OncoCyte 的總裁兼執行長 Josh Riggs；首席科學官 Ekke Schutz；和財務長 Andrea James。

Before turning the call over to Josh, I'd like to go over our safe harbor. The company will make projections and forward-looking statements regarding future events. Any statements that are not historical are forward-looking statements. These statements are made pursuant to, and within the meaning of the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995.

在將電話轉給喬許之前，我想先談談我們的安全港。該公司將對未來事件做出預測和前瞻性陳述。任何非歷史性的陳述都是前瞻性的陳述。這些聲明是根據 1995 年私人證券訴訟改革法案的安全港條款做出的，並且符合其含義。

We encourage you to review the company's SEC filings, including the company's most recent Form 10-Q, which identifies the risks and uncertainties that may cause future actual results or events to differ materially from those expressed or implied in the forward-looking statements.

我們鼓勵您查看該公司的美國證券交易委員會 (SEC) 文件，包括該公司最新的 10-Q 表，其中列出了可能導致未來實際結果或事件與前瞻性陳述中表達或暗示的結果或事件存在重大差異的風險和不確定性。

Please note that, the forward looking statements made during today's call speak only to the date they are made, and OncoCyte undertakes no obligation to update them to reflect subsequent events or circumstances, except as otherwise required under applicable law. Finally, we will conclude today's call with a Q&A session, with questions from our analysts as well as written questions that we have received from our investor community.

請注意，今天電話會議中做出的前瞻性陳述僅代表陳述做出之日的觀點，OncoCyte 不承擔更新這些陳述以反映後續事件或情況的義務，除非適用法律另有要求。最後，我們將以問答環節結束今天的電話會議，問答環節將回答我們分析師的問題以及我們從投資者社區收到的書面問題。

And with that, I would now like to turn the call over to you, Josh. Josh, you may begin.

說完這些，現在我想把電話交給你，喬希 (Josh)。喬希，你可以開始了。

Thanks, Julie. Welcome everyone and thanks for tuning in. The transplant market is changing and OncoCyte is a leading force in that change. Transplant centers around the world are realizing that, they do not have to accept the limitations of the current molecular testing model.

謝謝，朱莉。歡迎大家並感謝收看。移植市場正在發生變化，而 OncoCyte 是這項變化的主導力量。世界各地的移植中心都意識到，他們不必接受當前分子檢測模型的限制。

In Q3, we worked with our beta sites to bring up our tests and were able to celebrate our technology being run on three continents. We signed up leading transplant centers in our key markets, built upon our market leadership and clinical data generation, and took the first major steps in our FDA program. Milestone-after-milestone, promise-after-promise, we continue to deliver.

在第三季度，我們與測試網站合作進行測試，並慶祝我們的技術在三大洲運行。我們與主要市場的領先移植中心簽約，鞏固了我們的市場領導地位和臨床數據生成能力，並邁出了 FDA 計劃的第一步。我們不斷實現一個又一個里程碑、一個又一個承諾。

A year-and-a-half ago, we told the market that it was time to democratize transplant testing and today we are closer than ever to making that goal a global reality. The positive response from the transplant community tells us that we are on the right path and that we can count on their support to make our IVD product a reality, because at the end of the day local care can mean better care for patients.

一年半前，我們告訴市場，現在是時候實現移植測試的民主化了，而今天，我們比以往任何時候都更接近實現這一目標的全球現實。移植界的積極反應告訴我們，我們走在正確的道路上，我們可以依靠他們的支持來使我們的 IVD 產品成為現實，因為最終本地護理可以意味著為患者提供更好的護理。

Making dd-cfDNA testing broadly accessible means more research can be done, new questions will be answered, and progress will start to accelerate in the clinic. Transplant centers are tired of being left out of this important piece in the patient care value chain. They want to manage their patients locally and we believe that they should be able to participate in the economic value they create.

讓 dd-cfDNA 檢測廣泛普及意味著可以進行更多的研究，新的問題將得到解答，臨床的進展也將開始加速。移植中心對於被排除在病患照護價值鏈這一重要環節之外感到厭倦。他們希望在當地管理患者，我們相信他們應該能夠參與他們創造的經濟價值。

OncoCyte is committed to enabling both. Fast, easy-to-use, tests with strong revenue potential are a no brainer for most transplant centers across US This is the future they want and the ones they'll get. It feels gratifying to be able to report such great progress every quarter. We are retiring risk on our path to meaningful revenue. Demand for our GraftAssure RUO kit test is exceeding our expectations in Europe.

OncoCyte 致力於實現這兩者。對於美國大多數移植中心來說，快速、易於使用、具有巨大收入潛力的測試是理所當然的。每個季度都能報告如此巨大的進步，感覺很欣慰。我們正在消除風險，實現有意義的收入。歐洲對 GraftAssure RUO 試劑盒測試的需求超出了我們的預期。

And in the US, we believe, we are carving out potential meaningful market share, while also staying on pace with our FDA program. We are moving quickly and that's a testament to the team's dedication and hard work, our shareholder support, and the market enthusiasm for what we're building. Shortly after launching GraftAssure, we signed a top five transplant center here in the United States and a top five transplant center in Germany.

我們相信，在美國，我們正在開拓潛在的、有意義的市場份額，同時也與我們的 FDA 計劃保持同步。我們正在快速發展，這證明了團隊的奉獻精神和辛勤工作、股東的支持以及市場對我們所做工作的熱情。在推出 GraftAssure 後不久，我們就與美國排名前五的移植中心和德國排名前五的移植中心簽約。

In the long run, democratization of transplant testing is inevitable. What we are seeing here is just the first sign of the beginning. Just think, basically every other biomarker needed to manage a transplant patient can be measured locally, except for dd-cfDNA. And there's no good reason that dd-cfDNA should be any different. Transplant is a highly concentrated market and the top of our sales funnel skews towards the largest of the 100 transplant centers that matter the most in our space.

從長遠來看，移植測試的民主化是不可避免的。我們現在看到的只是一個開始的跡象。試想一下，除了 dd-cfDNA 之外，基本上管理移植患者所需的所有其他生物標記都可以在當地測量。並且沒有理由認為 dd-cfDNA 應該有所不同。移植是一個高度集中的市場，我們的銷售管道的頂端偏向我們所在領域最重要的 100 個移植中心中最大的中心。

We are actively talking to more than 30 sites that do high organ transplant volumes. We believe, we are on track to meet or exceed our site placement goal of having 20 sites signed by the end of next year. We believe each of these sites can eventually average about $1 million per year in high margin recurring clinical test kit revenue.

我們正積極與 30 多個器官移植量較大的機構進行洽談。我們相信，我們能夠達到或超過我們的站點佈局目標，即到明年年底簽署 20 個站點。我們相信，每個站點最終每年平均可獲得約 100 萬美元的高利潤經常性臨床測試套件收入。

So it's not hard to do the times one math, on how we think revenue will build once we achieve FDA clearance for our kits to be used in clinical decision making. And of course that's just the starting point. We expect that, the value proposition and regulatory clearance will drive accelerated adoption in both the US and the EU. We've engaged with the FDA and we'll have our first meeting with them in early December to go through our validation plan.

因此，做一次乘法計算並不難，我們可以計算出一旦我們的試劑盒獲得 FDA 批准用於臨床決策後，收入將會增加多少。當然，這只是一個起點。我們預計，價值主張和監管批准將推動美國和歐盟的加速採用。我們已經與 FDA 接洽，並將於 12 月初與他們舉行第一次會議，討論我們的驗證計劃。

We have a team of experienced hands that have put many products and devices through the agency. And I have every confidence that, we will find an efficient path to success. In recent weeks, I've spent a fair amount of time meeting face-to-face with many stakeholders in our industry, including customers and research partners and companies in our space, who are interested in strategically partnering.

我們擁有一支經驗豐富的團隊，已透過該機構銷售許多產品和設備。我堅信，我們一定能找到一條有效的成功之路。最近幾週，我花了大量時間與我們行業的許多利益相關者進行面對面會談，包括客戶、研究夥伴和我們領域內有興趣建立策略夥伴關係的公司。

I've traveled to meet with customers and partners not only in the US but also in Europe. We are leaning into the long-standing relationships we already have while we build and explore new potential commercial and strategic relationships. It seems like every stone we lift up, we're finding someone who is frustrated with the current industry practice and is looking to us for a better way.

我不僅去過美國，還去過歐洲，與客戶和合作夥伴會面。我們正在依靠現有的長期關係，同時建立和探索新的潛在商業和策略關係。似乎我們搬起的每一塊石頭，都讓我們發現有人對目前的產業實踐感到失望，並希望我們能找到更好的方法。

Our customers are telling us that our product is both easy-to-use and fast, and we believe that that sets us apart. If you can extract DNA, then most likely you can run our tests. And for censures that want same-day turnaround time, our digital PCR-based assay offers an advantage over NGS solutions. We believe, we are pursuing a form of the classic technological disruption strategy of introducing products that fundamentally change the nature of competition in a given market.

我們的客戶告訴我們，我們的產品既易於使用又快速，我們相信這使我們與眾不同。如果您可以提取 DNA，那麼很可能您就可以進行我們的測試。對於需要當天週轉時間的譴責，我們基於數位 PCR 的檢測比 NGS 解決方案更具優勢。我們相信，我們正在推行一種經典的技術顛覆策略，即推出能夠從根本上改變特定市場競爭性質的產品。

On the strategic side, we believe our IP gives us a seat at the table in the broader molecular diagnostic space, which will allow us to have productive conversations with strategic players both on the product side, such as the instrument makers, as well as with clinical service labs. And our IP has value not only in transplant, which currently gets most of our strategic focus and sales investment, but also in oncology.

從策略角度來看，我們相信我們的智慧財產權使我們在更廣泛的分子診斷領域中佔有一席之地，這將使我們能夠與產品方面的策略參與者（例如儀器製造商）以及臨床服務實驗室進行富有成效的對話。我們的智慧財產權不僅在移植領域具有價值（目前我們大部分的策略重點和銷售投資都集中在移植領域），而且在腫瘤學領域也具有價值。

We believe, we can continue to drive growth even after transplant is up and humming for us. I do want to highlight favorable data out of Milan related to one of our oncology products. DetermaIO, an immune classifier, continues to outperform standard-of-care biomarkers and assays.

我們相信，即使移植工作結束後，我們仍能繼續推動成長。我確實想強調米蘭與我們的一種腫瘤產品相關的有利數據。免疫分類器 DetermaIO 的表現持續優於標準護理生物標記和檢測方法。

A peer-reviewed study published in Clinical Cancer Research in September validated DetermaIO's utility to identify breast cancer patients most likely to benefit from atezolizumab. The takeaway for investors is threefold. Firstly, this study gets us one step closer to reimbursement for DetermaIO and we plan to add this to our data submission at CMS.

9 月發表在《臨床癌症研究》上的一項同行評審研究證實了 DetermaIO 在識別最有可能受益於阿替利珠單抗的乳癌患者方面的效用。投資者可以從中得到三點啟示。首先，這項研究使我們距離 DetermaIO 的報銷更近了一步，我們計劃將其添加到 CMS 的資料提交中。

Secondly, the data supports our ongoing DetermaIO partnering conversations. We believe we have identified partners who want market access to this technology on a global basis. And finally, it validates our R&D pipeline and shows our continuing progress in targeting a multibillion dollar addressable market in oncology diagnostics.

其次，數據支持我們正在進行的 DetermaIO 合作對話。我們相信我們已經找到了希望在全球範圍內獲得該技術市場的合作夥伴。最後，它驗證了我們的研發管道，並展示了我們在瞄準腫瘤診斷領域數十億美元潛在市場方面不斷取得的進展。

Even though we are a small company and we are still largely pre-revenue in transplant, we sit upon an established body of science and more than 10 years of research in the field. We believe, we have long been out in front with the clinical data that we are generating and have a strong pipeline to power new opportunities and growth well into the future.

儘管我們是一家小公司，在移植領域還未實現盈利，但我們擁有成熟的科學體系和該領域十多年的研究經驗。我們相信，我們在產生的臨床數據方面一直處於領先地位，並且擁有強大的管道來為未來的新機會和成長提供動力。

I'll hand it over to Andrea.

我會把它交給安德里亞。

Thank you, Josh. Hi, everyone.

謝謝你，喬希。大家好。

You'll notice in the shareholder letter that, we highlighted two areas of focus to de-risk our path to meaningful revenue. Those two areas are: One, signing new customers who should turn on nicely for us after we get FDA clearance for our kits. And two, preparing that FDA submission, so we can achieve clearance and those customers can start buying our kits to manage their patients.

您會在致股東的信中註意到，我們強調了兩個重點領域，以降低實現有意義收入的風險。這兩個領域是：第一，簽約新客戶，在我們的試劑盒獲得 FDA 批准後，這些客戶應該會為我們帶來良好的服務。第二，準備向 FDA 提交申請，這樣我們就可以獲得批准，那些客戶就可以開始購買我們的試劑盒來管理他們的患者。

In the meantime, while Josh and the rest of the senior leadership team focus on serving customers and advancing the science in our industry, my team and I are focused on capital allocation. And this includes tightly controlling expenses as well as ensuring access to capital to give us enough runway to get us to where we are self-sustaining.

同時，當 Josh 和其他高階領導團隊專注於服務客戶和推動產業科學發展時，我和我的團隊則專注於資本配置。這包括嚴格控制開支以及確保獲得資本，從而為我們提供足夠的跑道以實現自給自足。

Last month, we raised $10.2 million in gross proceeds in a private placement. We were thrilled to welcome support from existing investors, including our strategic partner Bio-Rad. We also welcome support from new investors.

上個月，我們透過私募籌集了 1,020 萬美元的總收益。我們很高興歡迎現有投資者的支持，包括我們的策略合作夥伴 Bio-Rad。我們也歡迎新投資者的支持。

We raised this capital at the market with no discount to the closing price and we raised it in a tough environment. I believe that we were able to accomplish this because investors can see the opportunity for us to generate healthy returns on their behalf.

我們在市場上籌集了這筆資金，沒有對收盤價打折，而且是在艱難的環境中籌集的。我相信我們之所以能夠實現這一目標，是因為投資者看到了我們為他們創造豐厚回報的機會。

We expect that growth capital allows us to keep executing on new customer agreements and keep pursuing FDA clearance. That capital also provides runway for us to continue actively pursuing additional strategic partners.

我們預計成長資本使我們能夠繼續履行新客戶協議並繼續獲得 FDA 批准。這筆資本也為我們持續積極尋求更多策略夥伴提供了平台。

We're growing increasingly excited about the long-term. Josh has stated for several quarters that molecular diagnostic testing particularly in transplant is moving away from a centralized lab solution and toward a kitted solution.

我們對長期目標越來越感到興奮。喬許已經連續幾個季度表示，分子診斷測試，特別是在移植領域的測試，正在從集中式實驗室解決方案轉向成套解決方案。

We believe that this disruption is going to happen and that OncoCyte can be a key driver of this trend for three reasons. First, our researchers have had a seat at the table since the beginning scientifically in establishing the donor derived, cell-free bio marker. We are now simply seeking a commercial seat at the table, which is no easy seat, but we believe that the science is behind us and the science is the hardest part.

我們相信這種顛覆將會發生，而 OncoCyte 可以成為這一趨勢的關鍵推動者，原因有三。首先，我們的研究人員從一開始就參與建立捐贈者衍生的無細胞生物標記的科學研究。我們現在只是在尋求一個商業席位，這並非一個容易的席位，但我們相信科學已經為我們提供了支持，而科學是最困難的部分。

Second, our digital PCR assay is a differentiator because it's easier to use and gives a faster result. We believe that, the existence of a digital PCR kitted transplant test with reimbursement enables our customer labs to participate in the economic value chain of transplant diagnostic testing.

其次，我們的數位 PCR 檢測與眾不同，因為它更容易使用，並且可以更快獲得結果。我們相信，可報銷的數位 PCR 試劑盒移植測試的存在使我們的客戶實驗室能夠參與移植診斷測試的經濟價值鏈。

Remember, we are aiming to design test kits to enable centers to perform the tests themselves and generate revenue for themselves. This increases the sustainability of care at the local level. It can also better serve patients with fast results.

請記住，我們設計測試套件的目的是使中心能夠自己進行測試並為自己創造收入。這提高了地方護理的可持續性。它還可以更好地為患者服務，並快速取得療效。

And third, we are small and nimble and we can adapt quickly. We have relatively low operating expenses and we strive to keep our cash burn low, so we can stay flexible. Finally, we are focused on ensuring we have the right people and processes in place to prepare for future scale. Last week, we gathered as a senior leadership team at our Innovation Center.

第三，我們規模小，行動敏捷，能夠快速適應。我們的營運費用相對較低，我們努力保持較低的現金消耗，以保持靈活性。最後，我們致力於確保擁有合適的人才和流程，為未來的規模做好準備。上週，我們高階領導團隊齊聚創新中心。

Our goal was to prepare for upcoming growth and think strategically about our long term objectives. We came out of those planning sessions energized to keep executing and keep building.

我們的目標是為即將到來的成長做好準備，並策略性地思考我們的長期目標。我們透過這些規劃會議獲得了充沛的精力去繼續執行和建立。

We're looking forward to delivering upon our mission to democratize access to molecular diagnostic testing, as well as creating shareholder value along the way.

我們期待履行我們的使命，使分子診斷測試更加民主化，並在此過程中創造股東價值。

Okay. Julie, do we have any questions in the queue?

好的。朱莉，我們還有什麼問題嗎？

Yes. We do. We have our first question from our analyst, Mike Matson from Needham. I'm assuming we can put you on speaker. Mike, are you there?

是的。是的。第一個問題來自我們的分析師，來自尼德姆的麥克馬森 (Mike Matson)。我想我們可以把你放在揚聲器上。麥克，你在嗎？

Hi. Yes. Thanks for taking our questions. Okay. Maybe just starting off with the first one, if you guys can maybe discuss, the role that Bio-Rad is playing here over the next year and change, I guess, before a potential FDA approval. Are you seeing assistance from them in opening up dialogue with these transplant centers or maybe individual physicians? So I guess, is there any assistance marketing the RUO product or do you think their role will be more robust?

你好。是的。感謝您回答我們的問題。好的。也許只是從第一個問題開始，如果你們可以討論一下，Bio-Rad 在未來一年將扮演什麼角色，以及在獲得 FDA 批准之前將發生哪些變化。您是否看到他們在與這些移植中心或個別醫生展開對話方面提供幫助？所以我想問一下，是否有任何幫助來行銷 RUO 產品，或者您認為他們的作用會更強大？

Yes, I think it's a great question. And I answered in two parts. I think we've got really nice experience here in the US And really, really good support over in Germany. We were over there about a month ago and we got to sit down with their Head of Central Europe and the commercial team. And they're absolutely excited to support us and they've been opening doors left and right for us in Central Europe.

是的，我認為這是一個很好的問題。我分兩部分來回答。我認為我們在美國擁有非常好的經驗並且在德國獲得了非常非常好的支持。大約一個月前我們去那裡並與他們的中歐地區負責人和商業團隊進行了交談。他們非常高興能夠支持我們，並且一直在中歐為我們打開大門。

They have really strong relationships as you might imagine, as a research, at least on the research side of their company with labs all across the countries that we're targeting. And so, that relationship has been very helpful for us. It gives us a feeling of being a heck of a lot bigger than we are. So when we go and set up a site, they also have, the Bio-Rad reps standing right there alongside, our team.

正如您可以想像的，作為一家研究機構，他們與我們所針對的各個國家的實驗室都保持著非常牢固的關係，至少在公司的研究方面是如此。所以，這種關係對我們非常有幫助。它讓我們感覺自己比實際上偉大得多。因此，當我們去建立一個站點時，他們也有 Bio-Rad 代表和我們的團隊站在那裡。

And so it feels like there's a really nice hand off, in that relationship, and it gives -- it gives the labs a lot of comfort. And I'd say in the US, they've certainly opened, doors where we don't have reach today. And so it's been fruitful for us, I would say. It gives us a lot more credibility than when we're standing at a transplant conference and most recently over at ASHI, Bio-Rad was there with us.

因此，感覺這種關係中的交接非常好，並且它給實驗室帶來了很大的安慰。我想說，在美國，他們確實打開了我們今天無法觸及的大門。所以我想說，這對我們來說是富有成果的。這給了我們比在移植會議上更高的可信度，最近在 ASHI，Bio-Rad 也和我們在一起。

They had -- their life science team was in the booth with us, giving confidence to folks that when they're talking to us, they're going to get the backing of $9 billion Company. So, yes, 100%, we've felt that support.

他們的生命科學團隊和我們一起在展位上，讓人們相信，當他們與我們交談時，他們將得到這家價值 90 億美元的公司的支持。所以，是的，我們 100% 感受到了這種支持。

Okay. Yes. That's great to hear and very helpful. And then I guess just -- it's early days and, what have you, but maybe just on the reception of the workflow for GraftAssure that you have introduced to the physicians thus far in this first phase. Are you seeing a lot of your reps or Bio-Rad reps dedicating a lot of time to teach, how to run GraftAssure, or would you say that, the teaching type of PCR-based assay?

好的。是的。我很高興聽到這個消息，這非常有幫助。然後我想只是——現在還為時過早，您有什麼，但也許只是關於您迄今為止在第一階段向醫生介紹的 GraftAssure 工作流程的接受度。您是否看到許多代表或 Bio-Rad 代表花費大量時間來教授如何運行 GraftAssure，或者您會說，基於 PCR 的檢測的教學類型？

No. I think it's an insightful question. Most folks that are trained on molecular are trained on PCR technology. And so, a lot of people just come with that kind of skill set to a molecular lab. So that, I would say the workflow is not foreign to most people. It is, there is -- there are nuances to the Bio Rad platform that we have to train on.

不。我認為這是一個很有見地的問題。大多數接受過分子訓練的人都接受過 PCR 技術訓練。所以，很多人就帶著這種技能來到分子實驗室。所以，我想說，這個工作流程對大多數人來說並不陌生。是的，Bio Rad 平台存在一些細微差別，我們需要對其進行訓練。

But I would say in general, it takes us about a week to two weeks to get folks up and going and comfortable with the technology, to where they're generating their own data.

但我想說，一般來說，我們需要大約一周到兩週的時間來讓人們熟悉並熟悉這項技術，直到他們能夠產生自己的數據。

And the way we've been working with our first group is, they're sending data to us on a daily basis and we're going through it with them, making sure that they're comfortable. We're learning about our assay and how it performs in the field. But we haven't experienced any meaningful challenges in just sort of the pure technology itself. It seems to be fairly easy to adopt and get set up and run.

我們與第一批客戶的合作方式是，他們每天向我們發送數據，我們與他們一起審閱，確保他們感到滿意。我們正在了解我們的分析方法以及它在該領域的表現。但我們在純技術本身方面還沒有遇到任何有意義的挑戰。它似乎相當容易採用、設定和運行。

Okay. Perfect. And maybe just one more, if that's all right. Could you maybe just discuss the value that the VitaGraft adds, especially to high risk transplant patients? And just kind of understanding where some of the clinical volume can come from.

好的。完美的。如果可以的話，也許再來一個。您能否討論一下 VitaGraft 增加的價值，尤其是對高風險移植患者而言？並且只是了解一些臨床數據的來源。

Do you expect that VitaGraft will be used among a subset of patients, maybe the high risk individuals that kind of need that test result in a much more expedited manner, or do you think by the time, that these hospitals are trialed, graft assured that they would be more apt to transition to VitaGraft more broadly or to a broader patient set?

您是否預計 VitaGraft 將在部分患者中使用，也許是那些需要以更快捷的方式獲得檢測結果的高風險人群，或者您是否認為到時候這些醫院進行試驗後，移植手術將確保他們更傾向於更廣泛地或向更廣泛的患者群體過渡到 VitaGraft？

Yes. I'm going to separate the question into two parts. So the GraftAssure assay is our RUO product. And so that's not really useful for the clinical population. But once we get to the IVD product, which we expect to call, VitaGraft.

是的。我將把這個問題分成兩個部分。因此，GraftAssure 檢測是我們的 RUO 產品。所以這對臨床人群來說並沒有什麼用。但是一旦我們得到 IVD 產品，我們就會稱之為 VitaGraft。

There's probably a handful of patients that need immediate testing. And then, the majority of the patients who -- there's some little blip on the clinical radar that the doctor wants to investigate.

可能有少數患者需要立即接受檢測。然後，大多數病人的臨床雷達上會出現一些小光點，需要醫生來檢查。

I would say that the transplant center will be heavily incentivized economically to capture and run as much testing, as they can in house.

我想說，移植中心將在經濟上獲得極大的激勵，並盡可能在內部進行盡可能多的測試。

And I think that will be the primary driver of the switch from send out to in house testing. But, yes, we really like, the market hasn't experienced same-day turnaround time, on testing. And so we don't know all of the use cases that could be there.

我認為這將是從發送測試轉向內部測試的主要驅動力。但是，是的，我們真的很喜歡，在測試中，市場還沒有經歷過當天的周轉時間。所以我們不知道所有可能存在的用例。

I don't know if that answers your question, but, I would expect that if I had an opportunity to build into the thousand for a test that I would want to do that as often as I could, when it's clinically needed.

我不知道這是否回答了您的問題，但是，我希望，如果我有機會進行一千次測試，當臨床需要時，我會盡可能多地進行測試。

Okay. Yes. I think that makes perfect sense. I think, common sense and the test will be helpful there. But since it's novel, it's more of a wait and see. That's all very helpful. Thank you very much for taking our questions.

好的。是的。我認為這很有道理。我認為，常識和測試將會有所幫助。但由於它還很新穎，因此還需要拭目以待。這一切都非常有幫助。非常感謝您回答我們的問題。

Mason Carrico from Stephens Inc.

Stephens Inc. 的 Mason Carrico

This is Ben on for Mason today. Thanks for taking the questions. You guys have, talked about transplant centers reaching out to you proactively to get access to the RUO product without, direct sales outreach from your end.

今天由班代替梅森上場。感謝您回答這些問題。你們談到了移植中心主動與你們聯繫以獲取 RUO 產品，而無需你們進行直接銷售推廣。

Could you sort of provide an update on how that's playing out? And then are there any specific use cases or research initiatives that, you think are a better product fit for yours versus, maybe competing offerings?

您能否提供一下事情進展的最新情況？那麼，您是否認為與競爭產品相比，有更適合您的特定用例或研究計劃？

I love the question. So the first thing I'll say is, we got outreach from a pediatric unit, not based here in the US And they were working with their patients and they were sending blood, all the way across the ocean to some labs in California trying to get an answer and it was taking them a month to get a result back.

我喜歡這個問題。因此，我要說的第一件事是，我們得到了來自一個不在美國境內的兒科部門的幫助，他們正在與患者合作，並將血液送到遠渡重洋的加州的一些實驗室，試圖得到答案，但他們花了一個月的時間才得到結果。

And so, when we went over there and set up, they had their entire team there, they had the adult team in the room and they had the Bio-Rad rep standing there and we all worked together for about a week-and-a-half. I'm getting them comfortable with the technology and showing that they could do this in house.

所以，當我們去那裡進行設置時，他們的整個團隊都在那裡，他們的成人團隊在房間裡，Bio-Rad 代表也站在那裡，我們一起工作了大約一個半星期。我讓他們熟悉這項技術並向他們展示他們可以在公司內部完成這項技術。

As of today, they're up and running and they're figuring out how to take care of their patient population locally and being able to manage those patients, those children right there. And I think that's for us a huge win that we know that we're empowering people that didn't have the access that they needed to this type of testing.

截至今天，他們已經開始運營，並正在研究如何在當地照顧患者群體並能夠就地管理這些患者和兒童。我認為這對我們來說是一個巨大的勝利，我們知道我們正在幫助那些無法獲得此類測試的人。

Beyond that, I think, we've been publishing over the past couple of months in anti-CD38 drugs. So these are drugs that are supporting patients or helping patients with antibody mediated rejection. And so far, I mean, we are way out in front of the rest of the world here on publishing data that says that donor-derived, cell-free DNA is useful.

除此之外，我認為，過去幾個月我們一直在發表有關抗 CD38 藥物的文章。這些藥物可以支持患者或幫助患者抵抗抗體介導的排斥反應。到目前為止，我們在發布表明捐贈者來源的無細胞 DNA 有用的數據方面遠遠領先世界其他國家。

We're also anticipating publication that shows that we're able to pick up antibody mediated rejection 10 months ahead using the absolute quantification that's native to our technology. And so, I think there are very clear use cases that we're developing that are sort of on the kind of the cutting-edge of what's possible with donor-derived, cell-free DNA.

我們也期待發表論文表明我們能夠利用我們技術本身的絕對量化方法提前 10 個月發現抗體介導的排斥反應。因此，我認為我們正在開發的非常明確的用例屬於捐贈者來源的無細胞 DNA 的前沿技術。

Whether it's only doable with our technology or other technologies will catch up, I can't really say today. But I do believe that, we are opening new markets with the science that we're doing.

這是否只有透過我們的技術才可行，或者其他技術能否趕上，我現在還無法斷言。但我確實相信，我們正在利用我們正在進行的科學研究來開拓新的市場。

Great. Really appreciate the backdrop there. Just a quick follow-up on the RUO product there. When you're in discussions with the transplant centers, can you speak to who are the decision makers in terms of whether that product is getting adopted? And then really just if you could share any of the common pushbacks that you may hear for why this product may not be the best fit for them and how you go about addressing that pushback.

偉大的。真的很欣賞那裡的背景。只是對 RUO 產品進行快速跟進。當您與移植中心進行討論時，您能否談談誰是決定該產品是否被採用的決策者？然後，您真的可以分享您可能聽過的任何常見反對意見，說明為什麼該產品可能不適合他們，以及您如何解決這些反對意見。

Sure. I'd say, you're going to need buy in from someone on the transplant side of the house. So if you think about, you have a lab manager and then you have a transplant center manager, you really need both of them together to get to, yes on this.

當然。我想說，你需要獲得移植部門某人的支持。所以如果你想想，你有一個實驗室經理，然後你有一個移植中心經理，你真的需要他們兩人一起努力才能實現這一點。

And so, we're looking for the transplant surgeons or nephrologists, who are research-minded, who have questions that they've been wanting to ask, but haven't been able to because of the current structure, sort of, and the availability of testing.

因此，我們正在尋找具有研究意識的移植外科醫生或腎臟病專家，他們一直想問一些問題，但由於目前的結構和檢測的可用性而無法提出。

And then, they go talk to the lab manager and say, ''We should really consider bringing this technology in house. We have this, that, or the other study that we would really like to run on our patients.'' And then, that's what really kicks off the process.

然後，他們去找實驗室經理說，“我們真的應該考慮將這項技術引入公司內部。”我們有這項、那項或其他研究，我們非常希望在我們的患者身上進行這些研究。然後，這才是真正啟動這項進程的過程。

And so, it's really it's a two part sale there. The hurdle that we have is kind of -- I mean, it's one that's kind of painfully obvious when you're trying to sell a sell a box into a lab is that, this is the first piece of content that's coming out on the QX600 for the transplant lab.

所以，這實際上是一個兩部分的銷售。我們面臨的障礙是——我的意思是，當你試圖將一個盒子賣給實驗室時，這一點顯而易見，這是 QX600 上為移植實驗室推出的第一部分內容。

And so you you're trying to work through, adoption of a new instrument into a lab that has one piece of content. And so, the value proposition has to be pretty strong to make that sale happen. I think so far we've felt a little bit of that pushback, but I think the demand to have access to technology so far has been winning the day.

因此，您要嘗試解決的問題是將新儀器引入具有單一內容的實驗室。因此，價值主張必須非常強大才能促成銷售。我認為到目前為止我們已經感受到了一點阻力，但我認為到目前為止，對獲取技術的需求仍然佔了上風。

Mark Massaro from BTIG.

BTIG 的馬克馬薩羅。

Hi, guys. This is actually Vidyun on for Mark. Thanks for taking the questions. So I understand that you're meeting with the FDA shortly. I guess what -- could you just provide some clarity on what's your supporting FDA pivotal study?

嗨，大家好。這實際上是 Vidyun 為 Mark 上場。感謝您回答這些問題。據我了解，您很快就要與 FDA 會面。我想問一下——您能否澄清一下您支持 FDA 的關鍵研究是什麼？

And additionally, do you plan on doing any concordant studies to on market transplant tests? I think I heard you talk about identifying AMR with 10 months of lead time over other tests. So maybe just some more discussion on when you would expect that publication?

此外，您是否計劃對市場上的移植測試進行任何一致性研究？我想我聽過您談到識別抗菌藥物抗藥性 (AMR) 比其他測試提前 10 個月。所以也許您只是想進一步討論一下您預計何時會出版該出版物？

Yes, great. So, I've got the -- what's going on with the publication relative to AMR detection and then the conversation with the FDA. So I'll take the FDA one first and then I'll go to the AMR question. I think it was about a month-and-a-half, two months ago, we submitted our validation plan into the FDA.

是的，太棒了。因此，我了解了與 AMR 檢測相關的出版物的進展情況，以及與 FDA 的對話情況。因此，我會先回答 FDA 問題，然後再回答 AMR 問題。我想大約一個半月到兩個月前，我們向 FDA 提交了我們的驗證計劃。

And basically we're looking at a Class 2 device here, so we're not looking at PMA. So that means that we're on track for clearance, not approval. And so, it's not a binary decision point. And I think we're doing a relatively simple study here.

基本上，我們在這裡查看的是 2 類設備，因此我們不查看 PMA。所以這意味著我們正在獲得審批，而不是批准。所以，這不是一個二元決策點。我認為我們在這裡進行的是一項相對簡單的研究。

We're looking at biopsy as the gold standard and doing a blood draw matched to biopsy and showing, in the data how good of a job we do in identifying graft damage in the blood. And that seems to be a fairly straightforward study design. We've got a lot of confidence that it will provide the data that we need to give the FDA confidence that we have a reliable assay, which at the end of the day is kind of the most important piece.

我們將活檢視為黃金標準，並進行與活檢相匹配的抽血，並透過數據展示我們在識別血液中的移植物損傷方面做得有多好。這似乎是一個相當簡單的研究設計。我們非常有信心，它將提供我們所需的數據，讓 FDA 相信我們有一個可靠的檢測方法，而這最終是最重要的部分。

We're only going in kidney to start off. I expect that once we have success there that we would do follow on submissions in the major transplant types like heart or lung or liver. But right now, we're focusing on the biggest piece of the market, which is clearly the kidney patient population. And to that and just want to make sure before I go on, did that answer all your questions around kind of the FDA program?

我們只是從腎臟開始。我希望，一旦我們在那裡取得成功，我們將對心臟、肺或肝臟等主要移植類型進行後續提交。但現在，我們關注的是最大的市場部分，這顯然是腎臟病患者群體。對此，在我繼續之前，我只想確保這是否回答了您有關 FDA 計劃的所有疑問？

Yes, that was perfect.

是的，太完美了。

Okay, great. And then, so the data that's going to publish is the data we presented back at ESOT, I believe this was last year and so the European Society of Transplantation, We showed in an interventional study, this is kind of important.

好的，太好了。然後，要發布的數據是我們在 ESOT 上展示的數據，我相信這是去年歐洲移植學會和我們在一項介入研究中表明的，這非常重要。

We these patients were randomized and then they were ruled in for biopsy based off of our assay. And this is the first time anybody has run an interventional study using donor-derived, cell-free, DNA to decide when to do a biopsy.

我們對這些患者進行了隨機分組，然後根據檢測結果安排他們進行活檢。這是第一次有人利用捐贈者來源的無細胞 DNA 進行介入性研究來決定何時進行活檢。

Normally, this test is used to rule out, because you're trying to avoid biopsies that aren't necessary. In this scenario, we're saying these patients need a biopsy because it's highly likely that they have antibody mediated rejection. And so, that's the study that's going to come out. We're excited about it, because I think it dovetails really well with the data that we've been publishing on the anti-CD38 drugs, felzartamab and daratumumab.

通常，此項測試用於排除，因為您要避免不必要的活檢。在這種情況下，我們認為這些患者需要進行活檢，因為他們很可能出現抗體介導的排斥反應。這就是即將得出的研究結果。我們對此感到非常興奮，因為我認為它與我們發布的有關抗 CD38 藥物 felzartamab 和 daratumumab 的數據非常吻合。

And so this is the drug that's now on by Biogen and then J&J's drug. And so that becomes important, like, if you have a drug that can actually treat antibody mediated rejection, it's important to catch it as early as possible, because the time loss here is graft loss.

這是目前 Biogen 和 J&J 公司生產的藥物。因此，這變得很重要，例如，如果您有一種藥物可以真正治療抗體介導的排斥反應，那麼儘早發現它很重要，因為這裡的時間損失就是移植物損失。

And so, there's going to be a lot of push to catch AMR as early as possible, so that you can get these patients on treatment as soon as possible to avoid significant damage to the kidney and eventual graft loss or death or they're going to have to go back on dialysis.

因此，我們將盡最大努力儘早發現 AMR，以便這些患者能夠盡快接受治療，避免腎臟受到嚴重損害以及最終導致移植物丟失或死亡，否則他們將不得不重新接受透析。

There's like a whole lot of bad outcomes that could be avoided if you can catch the AMR earlier. And we've got, what I believe is the best data out there. Certainly the only interventional data that's out there showing that you can catch it early enough to actually have an impact with these drugs.

如果能儘早發現 AMR，那麼許多不良後果就可以避免。我認為我們已經獲得了最好的數據。當然，現有的唯一干預數據可以表明，你可以儘早發現它，從而真正透過這些藥物產生影響。

That was perfect. Thanks, Josh. And then, maybe just a follow-up on the US sales funnel. I think you called out that this is 25% of transplant volumes. Just how long do you think that's going to take to convert that to revenue after securing FDA approval? And just what steps you've taken to prepare for launch there?

那太完美了。謝謝，喬希。然後，也許只是對美國銷售管道的後續。我記得您說過這佔移植量的 25%。您認為獲得 FDA 批准後，需要多長時間才能轉化為收入？您為在那裡發射採取了哪些準備措施？

Yes. Let me take a second to think on that one. So Andrea put together a really nice chart in our last shareholder letter, where we put out some thinking on what adoption could look like inside a major transplant center. And we don't expect that physicians are overnight going to just jump in and use our technology on 100% of the time on 100% of their patients. There's going to be some kind of lead in period.

是的。讓我花一點時間來思考這個問題。因此，安德里亞在我們上一封給股東的信中整理了一張非常漂亮的圖表，我們在其中提出了一些關於大型移植中心內部收養情況的想法。我們並不期望醫生一夜之間就能在所有的時間對所有病人使用我們的技術。將會有某種形式的引導期。

We're assuming about a six month or two quarter lead in from the point of time, when they've adopted the IVD product, to where you'll see a meaningful switch from sending out primarily to doing things in house. I think that may happen faster in the centers where they're already comfortable with our technology and that's where I think our pilot sites matter a lot.

我們估計，從他們採用 IVD 產品開始，大約需要六個月或兩個季度的時間，到你會看到從主要發送到內部完成的重大轉變。我認為在那些已經熟悉我們技術的中心這種情況可能會發生得更快，而且我認為我們的試點網站在這方面非常重要。

But I think for the new adopters, the ones that are adopting very close to the time when we have FDA-clearance are sort of like immediately after, there's going to be a lead in period.

但我認為，對於新採用者來說，也就是在我們獲得 FDA 批准後立即採用的人，會有一個引導期。

But I wouldn't expect it to last much longer than 6-9 months as they're kind of exploring how to work that in. And then after that, the argument to send out gets rather tenuous, just because you'll be able to do it yourself. It's a heck of a lot easier to send a tube of blood down the hall than it is to send it across the country.

但我預計它不會持續超過 6-9 個月，因為他們正在探索如何實現這一目標。然後在那之後，發送出去的論點就變得相當牽強，只是因為你可以自己做。將一管血液送到大廳比送到全國各地要容易得多。

(Operator Instructions) Julie, I'll turn the call back to you for the pre-submitted question.

（操作員指示）朱莉，我會將電話轉回給您，回答您之前提交的問題。

Sure. We have one question that came in via e-mail and the question is, can you explain why people wouldn't just use the NGS tests that are already out there?

當然。我們透過電子郵件收到了一個問題，問題是，您能解釋為什麼人們不直接使用已經存在的NGS測試嗎？

Yes. I love this question, and I think, Ekke is probably a really good person to answer this one for us. So, yeah. So, Ekke, if you can take the question on why wouldn't you just run the NGS test?

是的。我很喜歡這個問題，而且我認為 Ekke 很適合為我們回答這個問題。是的。那麼，Ekke，如果你能回答這個問題的話，為什麼不直接執行 NGS 測試呢？

Yes. Thank you for the question. I really like it. So we have developed the -- our test on digital PCR for good reasons. I start with the fact that digital PCR is way faster than what you ever can do with sequencing that right now with the current technology that is out there, is staying up to like 24, 30 hours before you can even have a result. And that really limits all these NGS technology to situations, where the doctor doesn't need an immediate answer.

是的。感謝您的提問。我非常喜歡它。因此，我們出於充分的理由開發了數位 PCR 測試。首先要說的是，數位 PCR 比目前的定序技術快得多，而定序需要 24 到 30 個小時才能得到結果。這實際上將所有這些 NGS 技術限制在醫生不需要立即得到答案的情況。

So for all indications, where the doctor wants to know what am I going to do, the NGS tests are not really feasible. So that was actually the reason why we went into that direction and we started developing the test.

因此，對於所有跡象表明醫生想知道我該怎麼做的情況，NGS 測試實際上並不可行。所以這實際上就是我們朝這個方向邁進並開始開發測試的原因。

The second reason is that if you're looking at NGS, the singleton alone comprises a high cost factor. So what labs need to do is to wait until they have enough samples together that they can put on one run of the NGS machine. So that's actually almost the same thing because it's all about timing. So you can just run one sample that is very urgent in your lab based on NGS.

第二個原因是，如果您正在考慮 NGS，單單單單是成本因素就很高。因此實驗室需要做的就是等到他們擁有足夠的樣本，然後將其放入NGS機器的一次運作中。所以這實際上幾乎是同一件事，因為這完全取決於時間。因此，您只需根據 NGS 運行實驗室中非常緊急的一個樣本即可。

Our test is different. It doesn't matter whether you're running 1 sample or 10 sample. The percent of costs are actually the same. So it's all really patient driven. If you need a fast result or a critical situation in the patient NGS does not serve you. So that's the major reason why we were going into the direction of PCR technology where you can easily get the results within one working day.

我們的測試有所不同。無論您運行 1 個樣本還是 10 個樣本都沒關係。成本百分比實際上是相同的。所以這一切都是由患者驅動的。如果您需要快速獲得結果或患者情況危急，則 NGS 不適合您。這就是我們進軍 PCR 技術的主要原因，該技術可以在一個工作天內輕鬆獲得結果。

Thank you for that, Ekke. And I think that that nails it, because I think most centers are going to struggle with the idea that they have to batch to get their costs down, because there's always going to be a couple of cases a week where you're going to want a quick answer. And that's just not a great place for NGS technology to serve. All right. Do we have anything else in the question queue there, Julie?

謝謝你，Ekke。我認為這很關鍵，因為我認為大多數中心都會難以接受透過分批處理來降低成本的想法，因為每週總會有幾個案例需要你快速得到答案。而這對NGS技術來說並不是一個理想的應用領域。好的。朱莉，我們還有其他問題嗎？

No more questions from where I can see.

就我所見，沒有其他問題了。

All right, man. Well, I appreciate everybody that tuned in and listened to us today. We look forward to continuing to update you guys on the progress that we're making as a company. We're having a lot of fun out here right now working with the transplant surgeons and researchers around the world. It feels really good. And so, thanks to everybody who's been supporting us, and we look forward to updating you all in the future.

好吧，夥計。好吧，我感謝今天收聽我們節目的每個人。我們期待繼續向你們通報我們公司所取得的進展。我們現在在這裡與世界各地的移植外科醫生和研究人員一起工作，非常有趣。感覺真好。因此，感謝所有支持我們的人，我們期待在未來為大家提供最新資訊。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。