Insight Molecular Diagnostics Inc (IMDX) 2024 Q2 法說會逐字稿

Thank you for standing by. My name is Rochelle, and I will be your conference operator today. At this time, I would like to welcome everyone to the OncoCyte second-quarter 2024 earnings conference call. (Operator Instructions)

謝謝你的支持。我叫羅謝爾，今天我將擔任你們的會議操作員。此時此刻，我歡迎大家參加 OncoCyte 2024 年第二季財報電話會議。（操作員說明）

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

我現在想將電話轉給 PCG Advisory 的 Jeff Ramson。請繼續。

Thank you, Rochelle, and thank you to everyone for joining us for today's conference call to discuss OncoCyte's second-quarter 2024 financial results and recent operating highlights. If you've not seen today's shareholder letter, please visit investors.oncocyte.com to read it. Today's prepared remarks build upon the information already shared in this robust letter.

謝謝 Rochelle，也謝謝大家參加今天的電話會議，討論 OncoCyte 的 2024 年第二季財務表現和最近的營運亮點。如果您還沒看到今天的股東信，請造訪 Investors.oncCell.com 閱讀。今天準備好的言論建立在這封強而有力的信中已分享的訊息的基礎上。

Before turning the call over to OncoCyte President and CEO, Josh Riggs, I'd like to go over our Safe Harbor statement. The company will make projections and forward-looking statements regarding future events. Any statements that are not historical facts are forward-looking statements.

在將電話轉給 OncoCyte 總裁兼執行長 Josh Riggs 之前，我想先回顧一下我們的安全港聲明。該公司將對未來事件做出預測和前瞻性陳述。任何非歷史事實的陳述均為前瞻性陳述。

These statements are made pursuant to and within the meaning of the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995. We encourage you to review the company's SEC filings, including the company's Forms 10-K and 10-Q, which identify risks that may cause future actual results or events to differ materially.

這些聲明是根據 1995 年《私人證券訴訟改革法案》的安全港條款作出的，並符合該條款的含義。我們鼓勵您查看公司向 SEC 提交的文件，包括公司的 10-K 和 10-Q 表格，其中識別可能導致未來實際結果或事件出現重大差異的風險。

OncoCyte expressly disclaims any intent or obligation to update these forward-looking statements, except as otherwise may be required under applicable law. Finally, we'll be taking questions toady on the line from our covering analysts as well as written questions from our investor community.

OncoCyte 明確表示不承擔任何更新這些前瞻性聲明的意圖或義務，除非適用法律另有要求。最後，我們今天將接受我們的分析師的線上提問以及投資者社群的書面提問。

I'd now like to turn the call over to Josh Riggs.

我現在想把電話轉給喬許·里格斯。

Thanks, Jeff. Welcome, and thank you for tuning in. We have on the call with us today our Chief Science Officer, Dr. Ekke Schütz; as well as Chief Financial Officer, Andrea James.

謝謝，傑夫。歡迎您，並感謝您的收聽。今天與我們通話的是我們的首席科學官 Ekke Schütz 博士；以及財務長安德里亞詹姆斯。

It's great to be able to announce the successful commercial launch of GraftAssure with our initial beta customers. We had confidence going into launch, but you never really know until your product is out in the field, and the feedback that we're getting is exceeding our expectations.

很高興能夠向我們的初始測試版客戶宣布成功商業推出 GraftAssure。我們對發布充滿信心，但直到您的產品投入使用之前，您永遠不會真正知道，並且我們得到的反饋超出了我們的預期。

As we started our pivot last year, we said we were going to do three things: to keep our cash burn low, produce a product, and welcome a channel strategic partner. And we've done all three, and we are thrilled with the partnership and investment from Bio-Rad. Those three pillars set us up beautifully to meet the commitment made earlier this year to launch our GraftAssure research product in Q2, which we are happy to say that we met.

當我們去年開始轉向時，我們說我們將做三件事：保持較低的現金消耗，生產產品，並歡迎通路策略夥伴。我們已經完成了這三項工作，我們對 Bio-Rad 的合作和投資感到非常興奮。這三大支柱讓我們完美地履行了今年早些時候所做的承諾，即在第二季度推出我們的 GraftAssure 研究產品，我們很高興地說我們已經實現了這一承諾。

Going forward, we expect to maintain a capital-light business model, focus on site adoption in the US and Germany, and deliver an IVD product to the market. Success in all three sets us up to disrupt the transplant testing market and deliver exceptional margins.

展望未來，我們預計將維持輕資本的商業模式，專注於美國和德國的站點採用，並向市場提供 IVD 產品。這三項的成功使我們能夠顛覆移植檢測市場並提供卓越的利潤。

Our Head of Commercial and I have been out in the field talking with customers and exploring more partnerships. It's just like a flower that keeps opening up. The more we engage with the market, the more it's responding.

我和我們的商務主管一直在現場與客戶交談並探索更多的合作關係。它就像一朵不斷開放的花。我們與市場接觸越多，市場的反應就越多。

We believe that over the next few years, our research product will double or triple the amount of research done using donor-derived cell-free DNA. This biomarker has been clinically accepted and is nearly standard of care, and yet you don't see an explosive growth in research.

我們相信，在接下來的幾年裡，我們的研究產品將使使用供體來源的無細胞 DNA 進行的研究量增加一倍或三倍。這種生物標記已被臨床接受並且幾乎成為護理標準，但您並沒有看到研究的爆炸性增長。

And we believe this is reflective of how the central lab model, which we aim to disrupt, has not been able to fully support the research community and all the questions that they want to ask. We know that there are a lot of these questions that are going unanswered today.

我們認為，這反映出我們旨在顛覆的中央實驗室模式無法完全支持研究界以及他們想要提出的所有問題。我們知道，今天有很多這樣的問題沒有得到解答。

Putting a research tool out there in the field and giving research institutions around the world access to it meets a real market need. And one of our early adopters is studying pediatric transplant patients. And sadly, there's a paucity of research in this space, and seeing one of our first centers jump in feels really good.

將研究工具放到現場並讓世界各地的研究機構使用它可以滿足真正的市場需求。我們的早期採用者之一正在研究兒科移植患者。遺憾的是，這個領域的研究很少，看到我們的第一個中心介入的感覺真的很好。

Empowering research not only serves the market more broadly, but it also creates new opportunities for OncoCyte, including in pharmaceutical research use. You can see the early innings of that with the Phase II clinical trial by HI-Bio, which used our VitaGraft kidney assay to monitor for responses to their anti-CD38 therapy. The results of which were published in the New England Journal of Medicine.

賦能研究不僅服務於更廣泛的市場，而且還為 OncoCyte 創造了新的機會，包括在藥物研究用途的機會。您可以透過 HI-Bio 的 II 期臨床試驗看到早期階段，該試驗使用我們的 VitaGraft 腎臟檢測來監測其抗 CD38 療法的反應。其結果發表在《新英格蘭醫學雜誌》。

Since then, a second publication has shown the ability to monitor for response to a second anti-CD38 therapy for antibody-mediated rejection. In this case series study, patients were given daratumumab off-label to treat antibody-mediated rejection, and VitaGraft Kidney was able to identify that the drug was working with a simple blood test.

此後，第二篇出版物顯示了監測第二種抗 CD38 療法對抗體介導的排斥反應的能力。在這個病例係列研究中，患者接受了標籤外達雷妥尤單抗治療抗體介導的排斥反應，VitaGraft Kidney 透過簡單的血液檢查就能夠確定該藥物正在發揮作用。

In addition to these publications, you may have seen in the shareholder letter that in the second quarter, we signed an agreement to be the provider of dd-cfDNA testing for a Phase II trial in AMR with a European biotechnology company. We think that this speaks to our growing market leadership and research partner of choice.

除了這些出版物之外，您可能在股東信中看到，在第二季度，我們與一家歐洲生物技術公司簽署了一項協議，成為 AMR II 期試驗的 dd-cfDNA 測試提供者。我們認為這說明了我們不斷增長的市場領導地位和選擇的研究合作夥伴。

Before I go on, there's an important real-world human element here to consider regarding the partnership with pharma. Many kidney transplant recipients experience antibody-mediated rejection. And when that happens, historically, there are not a lot of options for doctors or the patient. They may lose the organ and go back on dialysis or even eventually die, and it's a serious problem.

在我繼續之前，關於與製藥公司的合作，這裡有一個重要的現實世界人為因素需要考慮。許多腎臟移植受者都會經歷抗體介導的排斥反應。從歷史上看，當這種情況發生時，醫生或患者沒有太多選擇。他們可能會失去器官並重新接受透析，甚至最終死亡，這是一個嚴重的問題。

And we're humbled by the opportunity to support pharmaceutical companies as they study ways to solve that problem and turn an organ rejection from a potential death sentence into a manageable condition. Of course, detecting antibody-mediated rejection very early, which data has shown that our technology can do, will be very important to solving this problem once drugs are available that can treat the disease.

我們很榮幸有機會支持製藥公司研究解決問題的方法，並將器官排斥從潛在的死刑轉變為可控制的狀況。當然，一旦有可以治療這種疾病的藥物出現，儘早檢測到抗體介導的排斥反應（數據顯示我們的技術可以做到）對於解決這個問題將非常重要。

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 have long been out in front with the clinical data that we are generating.

儘管我們是一家小公司，在移植方面仍處於未獲利狀態，但我們擁有成熟的科學體系和該領域 10 多年的研究成果。長期以來，我們在產生的臨床數據方面一直處於領先地位。

We're excited, as you saw in the shareholder letter, that for the first time on July 11, researchers outside of OncoCyte began using our commercial research technology, GraftAssure. And it's a major effort for labs like this to bring up the workflow. It's a significant investment of time and resources, and they don't take it lightly.

正如您在股東信中看到的那樣，我們很高興看到 OncoCyte 以外的研究人員於 7 月 11 日首次開始使用我們的商業研究技術 GraftAssure。對於像這樣的實驗室來說，提高工作流程是一項重大努力。這是一項巨大的時間和資源投資，他們不會掉以輕心。

They are signing up because they believe in what we are building. We believe that these labs are exhausted by the send-out only model, and they want to work with us in building an IVD technology.

他們之所以簽約是因為他們相信我們正在建造的東西。我們相信這些實驗室已經厭倦了僅發送的模式，他們希望與我們合作建造 IVD 技術。

They want an IVD test so that they can detect transplant rejection quickly and easily on site, and they want to be able to run that test alongside (inaudible) routine tests. They, like us, believe in the power of democratized access to technology.

他們想要進行 IVD 測試，以便能夠在現場快速、輕鬆地檢測移植排斥反應，並且他們希望能夠與（聽不清楚）常規測試一起進行該測試。他們和我們一樣，相信民主化獲取科技的力量。

In our launch program, they start with some sample product to get comfortable using the assay before switching over to revenue-producing product. As we pointed out in the shareholder letter, we are about six weeks into the commercial launch of GraftAssure, and we have transplant centers that represent nearly 25% of the US transplant volume in our funnel and roughly the same percentage in Germany, our two key launch markets. This is exceptional and much faster than we would have expected with an RUO product.

在我們的啟動計劃中，他們從一些樣品產品開始，以適應使用檢測方法，然後再轉向創收產品。正如我們在股東信中指出的那樣，我們的GraftAssure 商業推出大約已經六週了，我們的移植中心占我們渠道中美國移植量的近25%，德國的比例大致相同，這是我們的兩個關鍵移植中心。這是非常出色的，而且比我們對 RUO 產品的預期要快得多。

The market enthusiasm for GraftAssure has given us the confidence to make some incremental investments in the back half of the year to support commercial launch and the FDA submission process for the IVD product. These investments include FDA compliance software engineering necessary to generate a test result, consumables to support the FDA submission, as well as an inventory build to bring customer sites up. We aim to hold our cash burn in Q3 and Q4 relatively in line with what you saw in Q2.

市場對 GraftAssure 的熱情讓我們有信心在今年下半年進行一些增量投資，以支持 IVD 產品的商業啟動和 FDA 提交流程。這些投資包括產生測試結果所需的 FDA 合規軟體工程、支援 FDA 提交的消耗品，以及啟動客戶網站的庫存建置。我們的目標是使第三季和第四季的現金消耗與第二季的情況相對一致。

Our product development team expects to deliver a completed data package to the FDA by summer next year. And depending on how quickly the FDA is processing submissions at that time, the earliest we could expect a positive coverage decision is in late Q4.

我們的產品開發團隊預計在明年夏天之前向 FDA 提供完整的資料包。根據 FDA 當時處理申請的速度，我們預計最早會在第四季末做出積極的承保決定。

We enjoy bench strength to support us in the IVD process, which is why I have invited Ekke to the call. He is here to help address any questions you might have today on the details of the FDA approval process.

我們擁有在 IVD 流程中支持我們的替補力量，這就是為什麼我邀請 Ekke 參加電話會議的原因。他在這裡幫助解決您今天可能對 FDA 審批流程細節產生的任何問題。

It's going to be a lot of fun in the next couple of years. We have a lot to execute, but we are dedicated to democratizing access to novel molecular diagnostic testing, improving patient outcomes, and creating substantial shareholder value along the way.

在接下來的幾年裡，這將會很有趣。我們有很多事情要做，但我們致力於使新型分子診斷測試的獲取民主化，改善患者的治療結果，並在此過程中創造可觀的股東價值。

Now I'd like to introduce a newcomer to our earnings call. We welcomed Andrea James to OncoCyte in June, and she has hit the ground running. Some of you may know Andrea from Tesla or Axon.

現在我想向我們的財報電話會議介紹一位新人。6 月份，我們迎來了 Andrea James 加入 OncoCyte，她已經開始投入工作。你們有些人可能認識特斯拉或 Axon 的 Andrea。

I'm thrilled to work with Andrea, and we are already benefiting so much from our insights, particularly when it comes to building and preparing for explosive growth. She is delivering decisive, analytical leadership and heterodox thinking to our team, and I'm delighted by the partnership.

我很高興與 Andrea 合作，我們已經從我們的見解中受益匪淺，特別是在構建和準備爆炸性增長方面。她為我們的團隊帶來了果斷、分析性的領導力和非正統的思維，我對這次合作感到很高興。

I've asked her to tell you why she came to OncoCyte. I think it was a great achievement for us to be able to attract her. And I think she sees in OncoCyte what we think the world will see over time. And as some of you know, Andrea has a history of being ahead of the curve. Andrea?

我請她告訴你她為什麼要來到 OncoCyte。我認為能夠吸引她對我們來說是一項偉大的成就。我認為她在 OncoCyte 中看到了我們認為隨著時間的推移世界將會看到的東西。正如你們中的一些人所知，安德里亞有著走在時代前沿的歷史。安德里亞？

Thank you, Josh. Hi, everyone. It's great to be here. And some of you may know me from Axon or Tesla or the sell side before that.

謝謝你，喬許。大家好。很高興來到這裡。你們中的一些人可能在 Axon 或 Tesla 或之前的賣方認識我。

As Josh said, I joined OncoCyte to help build and scale the company. There were four primary factors that drew me to OncoCyte: mission, timing, strategy, and team.

正如 Josh 所說，我加入 OncoCyte 是為了幫助建立和擴大公司規模。有四個主要因素吸引我加入 OncoCyte：使命、時機、策略和團隊。

First, the mission here is attractive, and it reminds me of what we had at Axon, which is to save lives. You'll notice in the new investor presentation we published today that we synthesized our mission very succinctly as follows: to democratize access to novel molecular diagnostic testing to improve patient outcomes.

首先，這裡的使命很有吸引力，它讓我想起我們在 Axon 的使命，那就是拯救生命。您會注意到，在我們今天發布的新投資者簡報中，我們非常簡潔地概括了我們的使命如下：使新型分子診斷測試的獲取民主化，以改善患者的治療結果。

We have an opportunity to do a lot of good with our technology and to do it quite soon, which brings me to timing. Where we are in our commercialization journey was very attractive to me. When I started talking with the company this spring, I learned that OncoCyte was just on the cusp of commercializing a product with more than a decade of history of development behind it.

我們有機會利用我們的技術做很多好事，而且很快就能做到，這讓我想到了時機。我們的商業化進程對我來說非常有吸引力。當我今年春天開始與該公司交談時，我了解到 OncoCyte 正處於商業化產品的風口浪尖，該產品背後有十多年的開發歷史。

My background is in tech and finance. I don't have a background in healthcare, and I wasn't interested in going to a company where it would take 10 years to bring a product to market. So thank you to those of you on the call who have worked for 10 years on this product.

我的背景是科技和金融。我沒有醫療保健背景，也沒有興趣去一家需要 10 年才能將產品推向市場的公司。感謝那些在電話中為這個產品工作了 10 年的人。

In addition to timing, I found the strategy to be highly compelling. I'm very much attractive to the strategy of selling diagnostic tests at software-like gross margins via a business model that is disruptive to the industry. We have the potential to be an asset-light, high-margin company that can scale quickly and eventually become quite large. The analyst and the investor in me has always appreciated businesses like that, and my guess is that many of you do, too.

除了時機之外，我發現這個策略非常引人注目。我對透過顛覆產業的商業模式以類似軟體的毛利率銷售診斷測試的策略非常感興趣。我們有潛力成為一家輕資產、高利潤的公司，能夠快速擴張並最終變得相當大。作為分析師和投資者，我一直很欣賞這樣的企業，我猜你們中的許多人也是如此。

Third, I was drawn to the quality of the team. We enjoy having world-renowned scientists in this company, including our Chief Science Officer, Dr. Ekke Schütz, who is on the line today. These scientists have extensive experience developing cell-free DNA products, developing immuno-oncology products, and with obtaining regulatory approval to sell diagnostic test kits.

第三，我被團隊的素質所吸引。我們很高興在這家公司擁有世界知名的科學家，包括我們的首席科學官 Ekke Schütz 博士，他今天在線上。這些科學家在開發無細胞 DNA 產品、開發免疫腫瘤學產品以及獲得監管部門批准銷售診斷測試套件方面擁有豐富的經驗。

This world-class expertise has created IP that we expect will support compelling margins. Josh Riggs, who is sitting here beside me in Irvine, California, is a deep subject matter expert. He exhibits a clear ability to make important decisions with a high degree of clarity.

這種世界一流的專業知識創造了智慧財產權，我們預計這些智慧財產權將支持令人矚目的利潤。喬什·里格斯 (Josh Riggs) 在加利福尼亞州歐文市坐在我旁邊，他是一位深入的主題專家。他表現出清晰地做出重要決策的清晰能力。

The company's pivot over the past few years has not been easy, and I admire the combination of smarts, integrity, and grit. It also helps to be a CFO stepping into a culture that already enjoys strong financial discipline. Of course, it was born of necessity, but I knew that this could be a great partnership. That muscle of fiscal discipline will remain strong, and it will support future operating leverage.

公司過去幾年的轉型並不容易，我很欣賞聰明、正直和毅力的結合。作為一名財務官，融入一種已經享有嚴格財務紀律的文化也很有幫助。當然，這是必然的，但我知道這可能是一次很好的合作。財政紀律的力量將保持強勁，並將支持未來的營運槓桿。

Okay. So the strategy makes sense and the team punches above their weight. Now the question is, how will this strategy play out? I saw three things that point to a company that is potentially in the early innings of success.

好的。所以這個策略是有道理的，團隊的表現也超出了他們的能力。現在的問題是，這項策略將如何發揮作用？我看到了三件事，表明一家公司有可能處於成功的早期階段。

First, we have great indications of product market fit. The interest we are already gaining with GraftAssure is pretty exciting. What's amazing is that research centers are proactively reaching out to OncoCyte to get access to the transplant diagnostic even without forward sales reach from us, and wouldn't it be great if we can invest more in that sales muscle and go faster.

首先，我們有很好的產品市場契合跡象。我們已經對 GraftAssure 產生了興趣，這非常令人興奮。令人驚訝的是，即使我們沒有進行遠期銷售，研究中心也主動與 OncoCyte 聯繫以獲得移植診斷，如果我們能夠在銷售力量上投入更多資金並加快速度，那不是很好嗎？

Second, the strategic investment and partnership with Bio-Rad really, really is a big deal. This company's channel partner is also its second largest investor. And third, the scientific validation has many proof points, the most recent of which appeared in the May 2024 publication of the New England Journal of Medicine.

其次，與 Bio-Rad 的策略性投資和合作確實非常重要。該公司的通路合作夥伴也是其第二大投資者。第三，科學驗證有許多證據點，其中最新的證據出現在 2024 年 5 月出版的《新英格蘭醫學雜誌》。

It was clear to me that OncoCyte is focusing on a scalable, high-margin product that fills a clear need and is selling it into prebuilt channels. This adds up to the potential to be a big winner.

我很清楚，OncoCyte 專注於一種可擴展、高利潤的產品，滿足明確的需求，並將其銷售到預先建立的管道。這加起來就有可能成為大贏家。

Now to be clear, I also came in with eyes wide open. While I knew some of the investors in the company and I was aware of their strong support, and while I was impressed with the management team and the Board, it is also true that we are a tiny company, our trading volume is still small, and we have a weak balance sheet. All of this was solvable.

現在要澄清的是，我也是睜大眼睛進來的。雖然我認識公司裡的一些投資者，也知道他們的大力支持，而且管理團隊和董事會給我留下了深刻的印象，但我們確實是一家小公司，我們的交易量仍然很小，我們的資產負債表很薄弱。這一切都是可以解決的。

What was also clear to me from my prior background is that investors will provide money to companies with certain characteristics. These characteristics include: the ability to move fast and capture opportunities, the ability to manage risks and retire them, and a compelling value proposition in the customer market. And this is where we are.

從我之前的背景中我也清楚知道，投資者會向具有某些特徵的公司提供資金。這些特徵包括：快速行動和捕捉機會的能力、管理風險和消除風險的能力，以及在客戶市場上引人注目的價值主張。這就是我們現在的處境。

The opportunity over the next two to three years is very large. In the near term, we have the opportunity to capture market share by selling a known biomarker test into the transplant diagnostic market. We also have a compelling opportunity over the 5- to 10-year period, which is the period I've always focused on with companies such as Tesla or Axon. Over that time frame, it is not unreasonable that we could become a $1 billion company. That potential is why I am here.

未來兩三年的機會非常大。在短期內，我們有機會透過向移植診斷市場銷售已知的生物標記測試來佔領市場份額。我們在 5 到 10 年期間也有一個引人注目的機會，這是我一直在關注特斯拉或 Axon 等公司的時期。在這段時間內，我們成為一家價值 10 億美元的公司並非沒有道理。這種潛力就是我來這裡的原因。

We have a compelling story to tell, and I'm eager to help tell it as well as guide it. As far as telling that story, you can see that with this earnings report, we are introducing a shareholder letter. We are also publishing a new investor deck that explains why we are investing in molecular diagnostic testing and specifically in developing test kits versus developing an in-house clinical lab model.

我們有一個引人入勝的故事要講，我很樂意幫助講述並指導它。就講述這個故事而言，您可以看到，在這份收益報告中，我們正在介紹一封股東信。我們也發布了一份新的投資者資料，解釋了為什麼我們投資於分子診斷測試，特別是開發測試套件，而不是開發內部臨床實驗室模型。

In these materials, we presented a graphic that is intended for you to understand why we are so excited about our beta customers that we are bringing up online as we speak. In the graphic, we show a projected revenue build that assumes we get FDA approval to sell an IVD product in late 2025 and assumes that the customer transplant center eventually switches from sending out their clinical tests to managing their patient populations in-house.

在這些資料中，我們提供了一張圖表，旨在讓您了解為什麼我們對我們在網路上發布的測試版客戶如此興奮。在圖中，我們顯示了預計的收入成長，假設我們在 2025 年末獲得 FDA 批准銷售 IVD 產品，並假設客戶移植中心最終從發送臨床測試轉向管理內部患者群體。

Now there's a reason why we do a forward-looking statement disclaimer on all projections, and that is because there are no guarantees. But we also felt that it was important to share our view of what we are building from where we sit today. You can count on us to be transparent on our growth journey. And that includes transparency not only about the opportunities, but also about the risks.

現在，我們對所有預測都做出前瞻性聲明免責聲明是有原因的，那就是因為沒有任何保證。但我們也認為，分享我們對今天正在建造的東西的看法也很重要。您可以信賴我們在成長過程中保持透明。這不僅包括機會的透明度，還包括風險的透明度。

As for the numbers we reported in the quarter, they're in the shareholder letter, and you don't need me to read off of tables for you. The one thing I would highlight is that our April fund raise was very successful. We had participation from new and existing investors, including our first corporate partner, Bio-Rad, and it was done at market with no warrant coverage and no discounts. This speaks to the fact that we have a real market opportunity to go after and that others in the capital markets are starting to see that opportunity.

至於我們在本季報告的數字，它們在股東信中，你不需要我為你讀出表格。我要強調的一件事是我們四月的融資非常成功。我們有新舊投資者的參與，包括我們的第一個企業合作夥伴 Bio-Rad，並且是在市場上完成的，沒有認股權證，也沒有折扣。這說明我們有一個真正的市場機會值得追求，而資本市場的其他人也開始看到這個機會。

I'd also highlight that with the preferred stock redemptions in April, we now enjoy a streamlined capital structure with just common stock and no debt or preferred stock, which hopefully excites you as much as it does me as we hit an inflection point. We truly value our partnership and relationship with the investment community, including our analysts and shareholders, so thank you for joining today, and we look forward to welcoming more investors over time as we grow.

我還要強調的是，隨著四月份的優先股贖回，我們現在享有精簡的資本結構，只有普通股，沒有債務或優先股，希望當我們遇到拐點時，這會讓您和我一樣興奮。我們非常重視與投資界（包括我們的分析師和股東）的合作夥伴關係和關係，因此感謝您今天的加入，隨著我們的發展，我們期待歡迎更多的投資者。

The opportunity set that we face is exciting. Day by day, our pass-through revenue is steadily being derisked. Once we are capturing that revenue, we think you'll be pleased with the leverage in the business model itself, which is both high gross margin and capital light.

我們面臨的機會令人興奮。日復一日，我們的轉手收入正穩定降低風險。一旦我們獲得了該收入，我們認為您會對業務模式本身的槓桿感到滿意，這種模式既高毛利率又輕資本。

Okay. So now we welcome your questions. Go ahead, Jeff. Do we have any questions in the queue?

好的。所以現在我們歡迎您提出問題。繼續吧，傑夫。我們還有什麼問題想問嗎？

We do. Rochelle, can you allow the verbal questions?

我們做到了。羅謝爾，你可以允許口頭提問嗎？

Certainly. (Operator Instructions) Mike Matson, Needham.

當然。（操作員說明）Mike Matson，Needham。

Hey, everyone. How's it going today? This is Joseph on for Mike.

嘿，大家。今天怎麼樣？這是麥克的約瑟夫。

Life's good, Mike. Thanks.

生活很美好，麥克。謝謝。

Yeah. This is Joseph on for Mike. But just a quick question on VitaGraft to start it out. I saw in the press release that you talked about increasing throughput at the CLIA lab. Just want to get an understanding of where this test stands. I assume volume hasn't started yet.

是的。這是麥克的約瑟夫。但首先要問一個關於 VitaGraft 的簡單問題。我在新聞稿中看到您談到了提高 CLIA 實驗室的通量。只是想了解這個測試的​​情況。我認為成交量還沒開始。

But maybe you could dissect that a little bit. Maybe this prep work, what are you aiming for for volume for this test? And then obviously, liver is still under review at CMS. So if you could give an update there, that would be helpful.

但也許你可以稍微剖析一下。也許是準備工作，您的測試量目標是多少？顯然，CMS 仍在對肝臟進行檢查。因此，如果您可以在那裡提供更新，那將會很有幫助。

Yeah. No, thanks for the question. I think what we've done is expanded our capacity in the lab in Nashville. So we're talking about an investment that we're making into that lab infrastructure. It's primarily to support the extra work that's coming at us for the FDA program.

是的。不，謝謝你的提問。我認為我們所做的是擴大了納許維爾實驗室的能力。所以我們正在談論我們正在對該實驗室基礎設施的投資。它主要是為了支持我們為 FDA 計劃進行的額外工作。

So that's just about the amount of samples and the amount of data that we need to generate to support the FDA submission. And so that's really more of a capital spend to support that effort.

這就是我們需要產生以支持 FDA 提交的樣本量和資料量。因此，這實際上是更多的資本支出來支持這項努力。

We've largely pulled back on most of our commercial efforts towards the LDT service product and put all of that energy into working on the site placements where we just had an overwhelming response and you needed to pivot our commercial team more towards activating sites for the RUO product.

我們已經在很大程度上撤回了針對LDT 服務產品的大部分商業努力，並將所有精力投入到網站佈局上，我們剛剛獲得了壓倒性的反響，您需要讓我們的商業團隊更多地致力於啟動網站RUO產品。

Okay. Yeah, that makes sense. So I guess maybe just to ask another question on that. As we look at the chart, I guess, you provided for the beta path. In terms of just material revenue before that inflection point, I guess, estimated inflection point around second half 2026, is there anything that we should start baking into our estimates? Or is the next really material driver IVD VitaGraft for Kidney?

好的。是的，這是有道理的。所以我想也許只是想問另一個問題。當我們查看圖表時，我猜您提供了測試路徑。就拐點之前的物質收入而言，我想，估計拐點在 2026 年下半年左右，有什麼我們應該開始納入我們的估計的嗎？或者是下一個真正的腎臟 IVD VitaGraft 材料驅動程式？

Yeah. With the low burn, every dollar of revenue feels material to us. But with the RUO product, I mean, it's going to be modest revenue. And it's hard for us to gauge that because this is a new product for the industry. They haven't had anything like this.

是的。由於燃燒率低，每一美元的收入對我們來說都很重要。但對於 RUO 產品，我的意思是，它的收入將是適度的。我們很難衡量這一點，因為這是該行業的新產品。他們沒有過這樣的事情。

So we could be pleasantly surprised by the orders, but I think we're going to keep those expectations modest for now until we get confidence that it's going to be much above. I think we do a good job in that graphic, highlighting that there's a relatively slow burn of revenue per site for the RUO product. And then as you pointed out, it really kicks up once we have an IVD product out there.

因此，我們可能會對訂單感到驚喜，但我認為我們現在將保持這些預期適度，直到我們有信心它會遠高於預期。我認為我們在該圖表中做得很好，突出顯示 RUO 產品的每個網站的收入消耗相對緩慢。正如您所指出的，一旦我們推出 IVD 產品，情況就會真正開始。

Okay. And then maybe just final question, just as we look forward to these next couple of years. In terms of site adoption and cash burn, just wondering how you're level setting that, if you're more looking at just finding the strategic centers and planting relationships there or if it's going to be a slow buildup of customers there over time.

好的。也許只是最後一個問題，就像我們對未來幾年的期望一樣。在網站採用和現金消耗方面，只是想知道您如何設定水平，您是否更注重尋找戰略中心並在那裡建立關係，或者隨著時間的推移，那裡的客戶是否會緩慢累積。

Thanks. I would say one advantage that we have in transplant is an exceptional concentration at the top. So transplant is a relatively complicated surgery, and so it tends to aggregate at the higher-end academic centers that's both here in the US and Europe and around the world.

謝謝。我想說，我們在移植方面的一個優勢是高層的高度集中。因此，移植是一項相對複雜的手術，因此它往往集中在美國、歐洲以及世界各地的高端學術中心。

And so any one of these top 100 centers feels meaningful to us because the top 100 here in the United States do 80% of the transplant volume or better. And so I guess, if I'm going to answer your question, I think when we get to 10 to 15 to 20 sites, we will have picked up a very meaningful percentage of that local market opportunity, and I think that's what we're excited about. So when we look at our funnel today, I mean, 25% of the US transplant volume is represented there. And so I mean all of these guys feel strategic to us.

因此，這些排名前 100 的中心中的任何一個對我們來說都有意義，因為美國排名前 100 的中心承擔了 80% 或更好的移植量。所以我想，如果我要回答你的問題，我認為當我們達到 10 到 15 到 20 個站點時，我們將獲得非常有意義的本地市場機會百分比，我認為這就是我們的目標很興奮。因此，當我們今天查看漏斗時，我的意思是，美國移植量的 25% 都集中在那裡。所以我的意思是所有這些人對我們來說都具有戰略意義。

Okay, great. Yeah, that's super helpful. Thank you very much for taking my question today.

好的，太好了。是的，這非常有幫助。非常感謝您今天回答我的問題。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey, guys. This is Vivian on for Mark. Thanks for taking the question. So as it relates to FDA approval, could you just remind us of any interim milestones, what publications and studies you're expecting to leverage to get there? I think in the press release, the Q-Sub was mentioned. And then I believe FDA clearance in late '25 represents your bull case, but just can you give us a range of the timing of that?

嘿，夥計們。這是薇薇安為馬克代言的。感謝您提出問題。那麼，由於它與 FDA 的批准有關，您能否提醒我們任何中期里程碑，您希望利用哪些出版物和研究來實現這一目標？我想在新聞稿中提到了 Q-Sub。然後我相信 FDA 在 25 年末的批准代表了你的樂觀觀點，但你能給我們一個時間範圍嗎？

Sure. I'll take some of the timing question, and then I'll ask Ekke to talk about the milestones that he has in front of him. We -- I guess we're very hopeful that the FDA will move quickly, and we don't really control that process. But we're going to give ourselves the best chance we have to get through by the end of '25. That may drift into early part of '26 just depending on how quickly the FDA is processing things at that time.

當然。我會回答一些時間問題，然後我會請 Ekke 談談他面前的里程碑。我們——我想我們非常希望 FDA 能夠迅速採取行動，但我們並不能真正控制這個過程。但我們將給自己最好的機會，讓我們在 25 年底前度過難關。這可能會推遲到 26 年初，具體取決於 FDA 當時處理事情的速度。

But Ekke, if you could, just talk a little bit about the key milestones that you have in front of us, the Q-Sub, and then what you guys are doing from a product development point of view and where you hope to be going into next year.

但是 Ekke，如果可以的話，請談談我們面前的關鍵里程碑，即 Q-Sub，然後從產品開發的角度講一下你們正在做什麼以及你們希望走向何方進入明年。

All right. Thank you. So our Q-Sub is planned like in six to eight weeks from now. We are right now putting all the material together. I would say we are 50% there. We are going to start, I would say, the revision process next week. So we are all going into that and divide it by all the needs.

好的。謝謝。所以我們的 Q-Sub 計劃在六到八週後進行。我們現在正在將所有材料放在一起。我想說我們已經做到 50%了。我想說，我們將於下週開始修訂程序。所以我們都在研究這個問題，並將其除以所有需求。

And it's a pretty formalized process, where you are just presenting your intended use, you're presenting the method or the assay, and you are presenting what kinds of studies, like analytical validation, clinical validation, you're planning. And then you ask the FDA a question, are you fine with that? Is our analytical validation according to what you are looking for? Is our clinical validation according to what you are looking for? And then we hope to get good answers.

這是一個非常正式的過程，您只需介紹您的預期用途，介紹方法或測定，並介紹您正在計劃的研究類型，例如分析驗證、臨床驗證。然後你問 FDA 一個問題，你同意嗎？我們的分析驗證是否符合您的要求？我們的臨床驗證符合您的需求嗎？然後我們希望得到好的答案。

We had made actually pretty good experience with the FDA when we did our BPD submission last year. They are very cooperative. And so they are really trying to work with you and not against you, which I really appreciated.

當我們去年提交 BPD 時，我們實際上已經與 FDA 取得了非常好的經驗。他們非常合作。所以他們真的在努力與你合作而不是反對你，我真的很感激。

So bottom line, there are some time to tell us, okay, this is -- okay, this might be for us. This is all that detail something where we want to have a modification, which at the end of the day helps us for the design and planning of our IVD endeavor.

所以最重要的是，有一些時間告訴我們，好吧，這可能適合我們。這就是我們想要修改的所有細節，最終有助於我們 IVD 工作的設計和規劃。

That said, also this IVD route is a very, very formalized way of putting documents and data together. It starts with Phase 1, which is a design setting and inputs. So you are completely put together how your design should look like and all the input in there like, okay, what are we going to achieve? What is our target? And that's something we want to get finalized by in, actually, six weeks from now.

也就是說，這種 IVD 途徑也是一種將文件和資料放在一起的非常非常正式的方式。它從第一階段開始，這是設計設定和輸入。所以你完全把你的設計應該是什麼樣子和其中的所有輸入放在一起，好吧，我們要實現什麼？我們的目標是什麼？實際上，我們希望在六週後最終確定這一點。

So we want to have that phase done in six weeks. And from there, you are getting into the second phase, which is development and design output. So from there, you are developing everything like work packages, what you want to do, how you want to do that, which study and so forth.

所以我們希望在六週內完成這個階段。從那裡開始，您將進入第二階段，即開發和設計輸出。因此，從那裡開始，你正在開發一切，例如工作包、你想做什麼、你想如何做、學習什麼等等。

And then the design output means you are controlling that what you have put into your design document really can be achieved. So that's the second so-called phase gate.

然後設計輸出意味著您正在控制您放入設計文件中的內容是否真正可以實現。這就是第二個所謂的相門。

And then the third phase is verification and validation. That's where we are going to do an analytical validation and [particular] validation with the, at that point, locked-in final product. And this, we have planned to get accomplished by Q4 '25/Q1 '26.

然後第三階段是驗證和確認。這就是我們要對當時鎖定的最終產品進行分析驗證和[特定]驗證的地方。我們計劃在 25 年第 4 季/26 年第 1 季之前完成這項任務。

So that's the entire plan. It's a lot of writing documents and just show the FDA that you are -- have thought about everything that needed to be thought about and that you are not just getting some data randomly put together by chance.

這就是整個計劃。這是大量的書面文件，只是向 FDA 表明您已經考慮了所有需要考慮的事情，而且您不僅僅是偶然隨機收集一些資料。

The entire idea behind that is (inaudible) so-called design control. Everything needs to be set from the very beginning, and then you are just working along what you have planned.

這背後的整個想法就是（聽不清楚）所謂的設計控制。一切都需要從一開始就設定好，然後你就照你的計畫去做。

Thank you, Ekke. Can I just want to make one comment on -- I apologize, but just one quick comment. Yeah. One thing that we've been pleasantly surprised with is the warm reception to the IVD program we felt from the community.

謝謝你，艾克。我可以只想發表一條評論嗎——我很抱歉，但只是一條簡短的評論。是的。讓我們感到驚喜的一件事是社區對 IVD 計畫的熱烈歡迎。

One of the questions we're asking these sites as we're bringing them up and we're moving them through the funnel is, hey, are you interested in participating in the IVD program? And it's just been overwhelmingly positive.

當我們提出這些網站並讓它們通過管道時，我們向這些網站提出的問題之一是，嘿，您有興趣參與 IVD 計劃嗎？這是非常積極的。

I think these centers want to help us get the samples together. They want to help us with the reproducibility studies. And so it's really feeling like a community effort here to push the IVD process along. So I think we're overwhelmed by the positive support that we're getting from the community. And I think we're -- there's just a general excitement that they're going to have access to this technology and they get to help make it happen.

我認為這些中心希望幫助我們收集樣本。他們想幫助我們進行再現性研究。因此，這裡確實感覺像是社區共同努力推動 IVD 流程的發展。所以我認為我們對來自社區的積極支持感到不知所措。我認為我們——人們普遍感到興奮，因為他們將能夠獲得這項技術，並且他們將幫助實現這一目標。

There are no further questions from the line at this time. I'd like to ask Jeff to see if we have any questions from the webcast.

目前，線路上沒有進一步的問題。我想請傑夫看看我們是否對網路廣播有任何疑問。

Yes, we do have a few, actually. Thank you. Josh, Andrea, how do you calculate the $1 billion transplant testing market opportunity? And how does OncoCyte plan to capture its $1 billion market opportunity?

是的，實際上我們確實有一些。謝謝。Josh、Andrea，你們該如何計算 10 億美元的移植偵測市場機會？OncoCyte 計劃如何抓住 10 億美元的市場機會？

I mean it's a good question. We put this out, I think, in our investor deck. We've got an estimate of somewhere around 3 million to 3.5 million testing opportunities globally. And that number, obviously, multiplying that by a mix of our RUO product and our IVD product, where we expect to be IVD in the US and Europe and then probably stay RUO Rest of World.

我的意思是這是一個好問題。我想，我們把這個放在了我們的投資者平台上。我們估計全球約有 300 萬到 350 萬個測試機會。顯然，這個數字乘以我們的 RUO 產品和 IVD 產品的組合，我們預計在美國和歐洲進行 IVD，然後可能在世界其他地區保持 RUO。

That market is growing, at least according to current estimates, about 9% a year. So we see that the $1 billion is a relatively conservative estimate of what the market opportunity is. We're not going to move that up until we have a chance to do more price discovery. And this is just something that's hard to do until you actually have the IVD product out there and know what you're going to get reimbursed.

至少根據目前的估計，該市場正在以每年約 9% 的速度成長。所以我們看到 10 億美元是對市場機會的相對保守的估計。在我們有機會進行更多價格發現之前，我們不會將其提高。在您真正擁有 IVD 產品並知道您將獲得什麼報銷之前，這是一件很難做到的事情。

So we're erring on the side of being conservative there. From a market capture point of view, I think we talked about this a good bit, but it's democratization, right? It's giving people access and it's meeting the demand where it is, which right now, the demand is at the local center and they don't have access to a technology that works for them today.

因此，我們在這方面採取保守態度是錯誤的。從市場佔領的角度來看，我認為我們對此進行了很好的討論，但這是民主化，對吧？它為人們提供了訪問權限，並滿足了當前的需求，而目前，需求位於當地中心，而他們目前無法獲得適合他們的技術。

Do you want to add just a little bit about that $1 billion total addressable market is based on the current clinical indications?

您是否想補充一點關於 10 億美元的潛在市場總額是基於當前臨床適應症的？

Yeah. I mean, I think the most exciting thing for us that's come out of the past two or three months is the work that's being done on like the anti-CD38 drugs, where they're really meeting an unmet clinical need from a pharma point of view. And that just opens up just these significant monitoring opportunities, so therapeutic efficacy monitoring, like is the drug working, and then also recurrence monitoring.

是的。我的意思是，我認為過去兩三個月對我們來說最令人興奮的事情是正在進行的工作，例如抗 CD38 藥物，它們確實從製藥角度滿足了未滿足的臨床需求看法。這恰恰開啟了這些重要的監測機會，因此治療效果監測，就像藥物的作用一樣，然後也是復發監測。

And we're seeing a lot of this in oncology right now. And there's just an enormous amount of value creation that's happening in the oncology space just like on that therapeutic efficacy and recurrence monitoring. And we're starting to see that emerge here in transplant.

我們現在在腫瘤學領域看到了很多這樣的情況。腫瘤學領域正在創造大量的價值，就像治療效果和復發監測一樣。我們開始看到這種情況在移植中出現。

And so we're -- we've got our fingers crossed that these trials will continue to be successful so that patients have an option instead of just losing their organ. And I think that creates -- that's an incredible tailwind for us because we're out in front there. And so I would say that easily expands the market opportunity that's in front of us.

因此，我們祈禱這些試驗將繼續取得成功，以便患者有一個選擇，而不僅僅是失去器官。我認為這對我們來說是一個令人難以置信的順風，因為我們處於領先地位。所以我想說，這很容易擴大我們面前的市場機會。

If I may, I would just add to what Josh was saying to make it really clear what the new situation that we have created is. I recall a Board meeting like perhaps eight months ago, where we were talking how much would you use the test in a high-risk population. And most of the people are saying, why should I? We don't have any therapy. Why do I want to know? And this has dramatically changed.

如果可以的話，我想補充一下喬許所說的內容，以明確我們所創造的新情況是什麼。我記得大約八個月前的一次董事會會議，我們在會議上討論了您會在高風險族群中使用多少測試。大多數人都在說，我為什麼要這麼做？我們沒有任何療法。我為什麼想知道？而這種情況已經發生了巨大的變化。

Now we have the first working therapy for chronic active antibody-mediated rejection, and it's not only something where we can show our test is perfect monitoring. It's also a huge, huge relief for patients who are suffering.

現在，我們有了第一個針對慢性活性抗體介導的排斥反應的有效療法，這不僅是我們可以證明我們的測試是完美監測的東西。對於遭受痛苦的患者來說，這也是一個巨大的緩解。

Because earlier than that, there was no therapeutic option and the organ would ultimately be lost, and now we have a therapeutic option. And our contribution is really to show that people are going into this disease earlier than we can do it with standard of care. And --

因為在此之前，沒有治療選擇，器官最終會失去，而現在我們有了治療選擇。我們的貢獻實際上是為了表明，人們患上這種疾病的時間比我們透過標準護理所能做到的更早。和--

Great. Thank you, Ekke.

偉大的。謝謝你，艾克。

I have one other question, Josh. How does OncoCyte envision building recurring revenue streams when most diagnostics currently are performed episodically?

我還有一個問題，喬許。當目前大多數診斷都是間歇性進行時，OncoCyte 設想如何建立經常性收入流？

Yeah. I would say the transplant is inherently a recurring revenue opportunity because these patients are living with their organs, hopefully, for 10, 12, 15 years or better. And unfortunately, though, there's a high rate of rejection. And so there's just inherently a number of touch points over the life of the patient.

是的。我想說，移植本質上是一個經常性收入機會，因為這些患者希望與他們的器官一起生活 10 年、12 年、15 年或更長時間。但不幸的是，拒絕率很高。因此，患者的一生中本質上存在著許多接觸點。

We're -- the physician just needs a non-invasive way or a minimally invasive way to check on that organ. We, along with the other players in the space, are meeting that need. And so I think it's just inherent to the product and the industry that we're in.

我們－醫生只需要一種非侵入性或微創的方式來檢查該器官。我們和該領域的其他參與者正在滿足這一需求。所以我認為這是我們所處的產品和產業固有的。

Got it. Okay, great. There's no more questions. Rochelle?

知道了。好的，太好了。沒有更多問題了。羅謝爾？

Currently, we don't have any questions from the line. (Operator Instructions)

目前，我們沒有收到任何來自線路的問題。（操作員說明）

Thanks, Rochelle. And Jeff, I guess we'll give it maybe like five seconds here for a pause, and then maybe Josh will close this out.

謝謝，羅謝爾。傑夫，我想我們會在這裡暫停五秒鐘，然後也許喬許會結束這個話題。

Okay. Guys, thanks everybody for joining us today. I mean we're obviously excited about where we're at as a company. It feels great to be out in the field with a product, engaging with the research community, and just feeling a groundswell of support. So we look forward to updating you guys on our product and capturing these sites across the United States and across Europe. I think we'll have some very exciting things to announce here in the future, and thanks for playing along.

好的。夥計們，感謝大家今天加入我們。我的意思是，我們顯然對我們公司的現狀感到興奮。帶著產品來到現場，與研究社群互動，並感受到巨大的支持，這種感覺真是太棒了。因此，我們期待向大家介紹我們的產品並捕獲美國和歐洲各地的這些網站。我想我們將來會在這裡宣布一些非常令人興奮的事情，感謝您的配合。

Thank you. Ladies and gentlemen, that concludes today's 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。