Grail Inc (GRAL) 2024 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Grail fourth-quarter 2024 earnings call.

女士們、先生們，大家好，歡迎參加 Grail 2024 年第四季財報電話會議。

At this time, all participants are in listen-only mode. (Operator Instructions)

此時，所有參與者都處於只聽模式。（操作員指令）

Please be advised that this conference call is being recorded.

請注意，本次電話會議正在錄音。

Grail Investor Relations, please begin.

請開始 Grail 投資者關係部門的工作。

Thank you and thank you all for joining us today. On the call, Bob Ragusa, our Chief Executive Officer; Aaron Freidin, our Chief Financial Officer; Dr. Joshua Ofman, our President; and Sir Harpal Kumar, our President, International Business and Biopharma.

謝謝大家，也謝謝大家今天的參與。在電話會議中，我們的執行長 Bob Ragusa；我們的財務長 Aaron Freidin；我們的總裁 Joshua Ofman 博士；以及我們的國際業務和生物製藥總裁 Harpal Kumar 爵士。

Before we get underway, I'd like to remind everyone that we'll be making forward-looking statements on this call based on current expectations. It's our intent that all statements other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity will be covered by the Safe Harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended in Section 21 of the Securities Exchange Act of 1934, as amended.

在我們開始之前，我想提醒大家，我們將根據目前的預期在本次電話會議上做出前瞻性的陳述。我們的意圖是，今天電話會議上所作的所有除歷史事實陳述之外的陳述，包括關於我們預期的財務業績和商業活動的陳述，均應受到 1933 年證券法第 27A 節（經修訂的 1934 年證券交易法第 21 節）中前瞻性陳述的安全港條款的約束。

Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and Grail assumes no obligation to update these statements.

前瞻性陳述受風險和不確定性的影響。實際事件或結果可能與預測或討論的大不相同。所有前瞻性聲明均基於目前可用的信息，Grail 不承擔更新這些陳述的義務。

To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Grail files with the SEC, including the risk factor section in Grail's most recent quarterly report on Form 10-Q and the company's upcoming annual report on Form 10-K. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which are adjusted to exclude certain specified items, including accounting impacts related to Illumina’s acquisition of Grail.

為了更了解可能導致實際結果不同的風險和不確定性，我們請您參閱 Grail 向美國證券交易委員會提交的文件，包括 Grail 最新的 10-Q 表季度報告中的風險因素部分以及該公司即將發布的 10-K 表年度報告中的風險因素部分。本次電話會議還將討論 GAAP 結果和某些非 GAAP 財務指標，包括調整後的毛利和調整後的 EBITDA，這些指標經過調整以排除某些特定項目，包括與 Illumina 收購 Grail 相關的會計影響。

Our non-GAAP financial measures are intended to supplement your understanding of Grail's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website, and with that, I'll turn the call Bob.

我們的非公認會計準則財務指標旨在補充您對 Grail 財務狀況的了解。今天發布的新聞稿中提供了非 GAAP 指標與最直接可比較的 GAAP 財務指標的對帳表，該新聞稿已發佈在我們的網站上，然後我將轉接電話給鮑伯。

Good afternoon, everyone, and thank you for joining us to review results for the fourth-quarter and full-year 2024. 2024 was a transformative year for Grail as we separated from Illumina and began publicly trading in June. In July, we completed final study visits for our two registrational studies, the NHS-Galleri study and PATHFINDER 2.

大家下午好，感謝您與我們一起回顧 2024 年第四季和全年業績。 2024 年是 Grail 轉型的一年，因為我們從 Illumina 分離出來並在 6 月開始公開交易。7 月份，我們完成了兩項註冊研究（NHS-Galleri 研究和 PATHFINDER 2）的最終研究訪問。

In the third and fourth quarters, we implemented a significant restructure intended to extend our [capital] runway past some major anticipated milestones, including the completion of our modular PMA submission for FDA approval of Galleri.

在第三季度和第四季度，我們實施了重大重組，旨在將我們的[資本]跑道延伸至一些預期的主要里程碑，包括完成 Galleri 的模組化 PMA 提交以獲得 FDA 批准。

In addition, we grew US Galleri revenue 45% year over year, selling more than 137,000 Galleri tests. We are pleased with Galleri's commercial momentum and are excited to progress initiatives to make it easier for physicians to order the test, including our recent integration into Quest Diagnostics Test Ordering System.

此外，我們在美國 Galleri 的營收年增了 45%，銷售了超過 137,000 個 Galleri 測試。我們對 Galleri 的商業發展勢頭感到滿意，並很高興能推進各項舉措，讓醫生能夠更輕鬆地訂購測試，包括我們最近與 Quest Diagnostics 測試訂購系統的整合。

This integration enables easy ordering for more than 500,000 physicians and allows patients to access the Galleri test at 7,400 quest locations nationwide without needing to bring along a test kit.

這項整合使 50 萬多名醫生能夠輕鬆訂購，並允許患者在全國 7,400 個 Quest 地點接受 Galleri 測試，而無需攜帶測試套件。

To discuss some additional recent highlights, I'll hand it over to Grail's President, Dr. Joshua Ofman.

為了討論一些最近的其他亮點，我將把它交給 Grail 總裁 Joshua Ofman 博士。

Thanks, Bob. As you may know, Galleri was designed to be utilized at population scale, and we've continued to enhance our technology and our laboratory infrastructure to enable all this future growth. Over the past several years, we've been working on an updated version of Galleri, which will enable efficient growth and support testing at scale.

謝謝，鮑伯。您可能知道，Galleri 的設計目標是適用於人口規模，並且我們一直在增強我們的技術和實驗室基礎設施，以實現未來的成長。在過去的幾年裡，我們一直致力於 Galleri 的更新版本，它將實現高效成長並支援大規模測試。

At the end of 2024, we rolled this enhanced version out, which includes a reduced panel size, allowing us to lower sequencing costs, and to run approximately four times the number of samples on every flow cell. Additionally, the testing workflow is now both fully automated and integrated, meaning we've been able to eliminate numerous manual steps in the lab, allowing for much greater efficiency.

2024 年底，我們推出了這個增強版本，它包括縮小的面板尺寸，使我們能夠降低定序成本，並在每個流動槽上運行大約四倍的樣本數。此外，測試工作流程現在已完全自動化和集成，這意味著我們能夠消除實驗室中的大量手動步驟，從而大大提高效率。

The implementation of these updates has substantially expanded our lab capacity, and we do not anticipate any additional CapEx investment will be needed to support our expected volume for the foreseeable future of the next several years.

這些更新的實施大大擴展了我們實驗室的容量，我們預計在未來幾年可預見的未來不需要任何額外的資本支出投資來支持我們預期的產量。

We began offering this version of the test in December and expect to see [COGS] improvements as we continue to scale. We're also really pleased that the US military's TRICARE Health Insurance Program has added the Galleri test to the approved list of lab developed tests as a covered benefit for patients who are 50 years or older with an elevated risk of cancer.

我們從 12 月開始提供此版本的測試，並希望隨著規模的不斷擴大，看到 [COGS] 的改進。我們也非常高興，美國軍方的 TRICARE 健康保險計劃已將 Galleri 測試添加到實驗室開發測試的批准名單中，作為 50 歲或以上患有癌症風險較高的患者的保險福利。

This addition came after the Defense Health Agency reviewed Galleri to determine if it met TRICARE requirements for both safety and effectiveness. We're currently working with TRICARE's carriers to implement this new offering.

在國防衛生局對 Galleri 進行審查以確定其是否符合 TRICARE 的安全性和有效性要求後，該公司做出了這項決定。我們目前正在與 TRICARE 的營運商合作實施這項新產品。

We're really pleased with the progress we've made since Grail was founded in 2016. The Galleri test is identifying deadly cancers in asymptomatic adults in clinical care today. We continue to demonstrate our scientific leadership in this emerging field to completely transform how we screen for cancer and to dramatically improve the cancer detection rate in the population.

我們對 Grail 自 2016 年成立以來的進展感到非常高興。如今，Galleri 測試正在臨床治療中識別無症狀成人的致命癌症。我們將繼續展示我們在這一新興領域的科學領導地位，徹底改變我們篩選癌症的方式，並大幅提高人群的癌症檢出率。

We continue to make progress on our modular FDA submission, and we're looking forward to continuing to help individuals and their families detect cancer early when it can be cured. To discuss our fourth quarter financial results, I'll hand it over to Grail's Chief Financial Officer, Aaron Freidin.

我們在模組化 FDA 提交方面繼續取得進展，我們期待繼續幫助個人及其家人在癌症可以治愈時儘早發現癌症。為了討論我們的第四季度財務業績，我將把它交給 Grail 的財務長 Aaron Freidin。

Thanks, Josh, and good afternoon, everyone. I'm pleased to present results for our fourth quarter and the full year of 2024. Fourth-quarter results were strong, with revenue of $38.3 million up $7.9 million or 26% as compared to Q4 2023. Total revenue for the quarter is comprised of $31.6 million of screening revenue and $6.7 million of development services revenue.

謝謝，喬希，大家下午好。我很高興展示我們 2024 年第四季和全年的業績。第四季業績強勁，營收為 3,830 萬美元，與 2023 年第四季相比成長 790 萬美元，增幅為 26%。本季總收入包括 3,160 萬美元的篩選收入和 670 萬美元的開發服務收入。

Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development.

開發服務收入包括我們為生物製藥和臨床客戶提供的服務，包括臨床研究、中試、研究和治療開發的支援。

Full-year revenue was $125.6 million up 35% from full-year revenue in 2023. 2024, full-year revenue was comprised of $108.6 million revenue, up 45% over full-year 2023 and in line with our narrowed guidance in the fall of 40% to 50% growth. Revenue also included $17 million of development service revenue, a decrease of 6% from 2023. We see continued demand for our Galleri test and sold more than 40,000 tests in the fourth quarter, and a total of approximately 137,000 tests throughout the year.

全年營收為 1.256 億美元，較 2023 年全年營收成長 35%。 2024 年全年營收為 1.086 億美元，較 2023 年全年成長 45%，符合我們秋季 40% 至 50% 成長的縮小預期。收入還包括 1,700 萬美元的開發服務收入，較 2023 年下降 6%。我們看到 Galleri 測試的需求持續成長，第四季售出超過 40,000 個測試，全年共售出約 137,000 個測試。

Screening revenue of $31.6 million in the fourth quarter was up 39% as compared with the fourth quarter of 2023, primarily based on increased sales volumes. Development service revenue in Q4 '24 was $6.7 million, a decrease of 13% as compared with the fourth quarter of 2023. Net loss for the quarter was $97.1 million, an improvement of 48% as compared to Q4 2023.

第四季的放映收入為 3,160 萬美元，與 2023 年第四季相比成長了 39%，這主要得益於銷售量的增加。24 年第四季的開發服務收入為 670 萬美元，與 2023 年第四季相比下降了 13%。本季淨虧損為 9,710 萬美元，與 2023 年第四季相比改善了 48%。

Net loss for the full year was $2 billion, an increase of $561 million or 38% as compared to full-year 2023. Net loss was primarily driven by goodwill and intangible asset impairments. Non-GAAP adjusted gross profit for the fourth quarter of 2024 was $17.9 million, an increase of $2.6 million or 17% as compared with Q4 2023.

全年淨虧損 20 億美元，較 2023 年全年增加 5.61 億美元，增幅 38%。淨虧損主要由於商譽和無形資產減損。2024 年第四季非 GAAP 調整後毛利為 1,790 萬美元，較 2023 年第四季增加 260 萬美元或 17%。

Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased Galleri volume. Full-year non-GAAP adjusted gross profit was $57.8 million, an increase of $17.6 million or 44% as compared with full-year 2023.

利潤率成長的主要驅動因素是 Galleri 銷售成長帶來的營收組合和規模效率。全年非 GAAP 調整後毛利為 5,780 萬美元，較 2023 年全年增加 1,760 萬美元或 44%。

Adjusted EBITDA for the fourth quarter of 2024 was negative $84 million, representing an improvement of $39.4 million or 32% as compared to Q4 2023. Adjusted EBITDA for the full-year 2024 was negative $483.5 million, an improvement of $40.3 million or 8% as compared to full-year 2023.

2024 年第四季調整後 EBITDA 為負 8,400 萬美元，與 2023 年第四季相比改善 3,940 萬美元，增幅為 32%。2024 年全年調整後 EBITDA 為負 4.835 億美元，較 2023 年全年改善 4,030 萬美元，增幅 8%。

We ended the year with a cash position of $766.8 million. We are focused on driving growth efficiently and reducing our spending profile. In 2024, we made significant strides here, and we plan to continue to reduce burn in 2025. In January, we guided that we expect cash burn for the full year of 2025 to be no more than $320 million, a projected decrease of more than 40% of our cash burn in 2024.

截至年底，我們的現金餘額為 7.668 億美元。我們專注於有效推動成長並減少支出。2024 年，我們在這裡取得了重大進展，並計劃在 2025 年繼續減少燒錢。今年 1 月，我們預計 2025 年全年現金消耗不超過 3.2 億美元，預計將比 2024 年現金消耗減少 40% 以上。

As we've shared before, our cash runway extends into 2028, enabling us to achieve major milestones, such as readouts of our registrational studies and completion of our modular PMA submission.

正如我們之前所分享的，我們的現金跑道延伸至 2028 年，這使我們能夠實現重要的里程碑，例如讀取我們的註冊研究並完成我們的模組化 PMA 提交。

I'll turn it back to Bob for concluding remarks.

我將把話題交還給鮑伯來做最後發言。

Thank you, Aaron. Since the separation from Illumina in June of last year, we have made great progress as a public company. We have seen strong growth for Galleri, improved our cost efficiency, and recently completed a major initiative to launch the new version of the test preparing us for scalability. We believe we are in a strong financial position and are pleased with the momentum we are seeing as we continue to drive multi-cancer early detection from an idea towards becoming a new standard of care.

謝謝你，亞倫。自去年六月與 Illumina 分離以來，我們作為一家上市公司取得了長足的進步。我們看到 Galleri 實現了強勁成長，提高了成本效率，並且最近完成了一項重大計劃，推出了新版本的測試，為我們的可擴展性做好了準備。我們相信，我們的財務狀況良好，並且對我們所看到的勢頭感到滿意，我們將繼續推動多癌症早期檢測從一個想法走向成為一種新的治療標準。

We are in the final stages of data collection for our registrational studies, and are looking forward to readouts from the PATHFINDER 2 and NHS Galleri studies, as well as completion of our modular PMA submission with the FDA in the first half of 2026.

我們正處於註冊研究資料收集的最後階段，期待獲得 PATHFINDER 2 和 NHS Galleri 研究的數據，並在 2026 年上半年完成向 FDA 提交的模組化 PMA。

We are grateful to our employees for their incredible commitment and dedication to our mission to detect cancer early when it can be cured.

我們感謝我們的員工對我們的使命所做的令人難以置信的承諾和奉獻，即儘早發現和治癒癌症。

We'll now turn the call over to Q&A. Operator, please go ahead.

我們現在將電話轉入問答環節。接線員，請繼續。

(Operator Instructions)

（操作員指令）

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Okay, good afternoon, and thank you for taking my questions. And I'll just, I think I have two, and I'll just throw them out there and get out of the way. First, I think it's a Josh' question regarding essentially the new Galleri, if you will. Would you be able to share a little more detail on how the lower COGS per test allows you to be more flexible from a pricing standpoint?

好的，下午好，感謝您回答我的問題。我想我有兩個，然後我就把它們扔出去，然後走開。首先，我認為這是 Josh 關於新 Galleri 的問題，如果你願意的話。您能否詳細分享如何透過降低每次測試的 COGS 讓您在定價方面更加靈活？

And, maybe more importantly, I'm just wondering if in the early going, you're seeing anything to suggest that lower pricing will actually result in actual true elasticity for the test in terms of demand. So really a question about how low COGS can go? How much it allows you to change pricing, and whether you're seeing any evidence of elasticity in the market?

而且，也許更重要的是，我只是想知道，在早期階段，您是否看到任何跡象表明較低的價格實際上會導致測試在需求方面具有真正的彈性。所以真正的問題是 COGS 可以降到多低？它允許您在多大程度上改變定價，以及您是否看到市場彈性的任何證據？

And then, the second topic is more of a current events question on MCED. And, our understanding is that, this, that essentially that the bill was reintroduced in the house a couple of weeks ago. I'm wondering if you could share anything in terms of what you're hearing and what might come next there.

然後，第二個主題更像是 MCED 上的時事問題。我們的理解是，這項法案基本上是在幾週前在眾議院重新提出的。我想知道您是否可以分享您所聽到的內容以及接下來可能發生的事情。

Thank you very much.

非常感謝。

Great. Thank you, Doug.

偉大的。謝謝你，道格。

Josh, I'll let me take it first and I'll go over to you. Yeah, so I appreciate the questions. So on the new version of the test, as Josh mentioned in his prepared remarks, the, we're able to put significantly more samples on a 4x the number of samples due to a more focused panel, so clearly we have a near-term reduction in variable reduction in COGS.

喬希，我先拿到它，然後再交給你。是的，我很感謝你們的提問。因此，在新版本的測試中，正如 Josh 在準備好的發言中提到的那樣，由於小組更加集中，我們能夠在 4 倍數量的樣本上放置更多的樣本，因此很明顯，我們在短期內減少了 COGS 的變量減少。

In terms of the longer term and any price elasticity, we really look at this platform to be able to build out the scalability and the long-term cost structure that we'll need in order to be what, we think kind of population scale, pricing and margins we'll get to. And so, we won't see the fixed-cost leverage on the automation that Josh referred to for a period of time until volumes really build. So we haven't done the elasticity testing with it, and so we'll, it's really a future proofing and to get us to the scalability and cost structure that we know we'll need over the long term.

從長期和任何價格彈性的角度來看，我們真正關注的是這個平台是否能夠建立我們需要的可擴展性和長期成本結構，以便達到我們認為的人口規模、定價和利潤率。因此，在產量真正增加之前，我們不會在一段時間內看到 Josh 提到的自動化固定成本槓桿。因此，我們還沒有對它進行彈性測試，因此，這實際上是一種未來的證明，並使我們達到我們知道長期需要的可擴展性和成本結構。

Josh, any pieces to add on that?

喬希，還有什麼要補充的嗎？

No, just that, we'll be it's early days and as volumes increases, we'll be able to take advantage of that scalability but not today.

不，只是這樣，我們還處於早期階段，隨著數量的增加，我們將能夠利用這種可擴展性，但不是今天。

Yeah. Yeah, the legislation, so we remain encouraged, by the reintroduction, by the momentum, the stakeholder groups that have been advocating for this, remain very, very strong and vocal. We continue to have bipartisan bicameral support for the bill. So, a lot of good momentum really looking for the right vehicle and to be able to move it forward. But again, I would say no real change in the level of support for it.

是的。是的，這項立法讓我們感到鼓舞，因為它的重新引入，它的勢頭，以及一直倡導這項立法的利益相關者團體，仍然非常、非常堅定且直言不諱。我們繼續獲得兩黨兩院對法案的支持。因此，許多良好的勢頭確實在尋找合適的工具並能夠推動其向前發展。但我再次指出，對它的支持程度並沒有發生真正的改變。

And Josh, maybe I don't know if you have any other colors?

喬希，也許我不知道你還有其他顏色嗎？

No, I think that's right. We're, it's got great support, bicameral, bipartisan. It's been reintroduced and we're hopeful that in one of the moving vehicles, either the first spending bill or in reconciliation that it'll get seriously considered.

不，我認為是這樣。它得到了兩院和兩黨的大力支持。該法案已被重新提出，我們希望，在其中一個行動方案中，無論是第一項支出法案還是和解法案，它都會被認真考慮。

Thank you again, guys.

再次感謝你們。

[Jay Savant], Morgan Stanley.

[傑伊·薩凡特]，摩根士丹利。

Sorry, hi, this is [Jason Abantegius]. Congratulations on the quarter and thank you for taking our questions. So maybe just starting off on the recent collaboration with Quest Diagnostics. Can you share what's embedded in your 2025 guide regarding this collaboration and confirm if it was incorporated in your pre-announcement from mid-January? And, similarly, on a similar note, the TRICARE news was this incorporated in your mid-January 2025 guide or do they represent sources of upside? Thank you.

抱歉，你好，這是[傑森·阿班特吉烏斯]恭喜本季取得的成績，並感謝您回答我們的問題。因此也許剛開始與 Quest Diagnostics 的最近合作。您能否分享一下 2025 年指南中有關此次合作的內容，並確認它是否已納入您 1 月中旬的預先公告中？同樣，TRICARE 新聞是否包含在您 2025 年 1 月中旬的指南中，或者它們是否代表了上行來源？謝謝。

Yeah you want to think about, yeah, definitely, yeah, so we're excited about both these opportunities as Josh, really elaborated on for both Quest and TRICARE. Quest is going to make the test directly available to be ordered through their system. Patients won't need to take a, get a kit to go with their blood drawn and so on. And TRICARE, as Josh said, very excited and working with the payers to implement coverage. As far as guidance goes, we contemplated several things and opportunities for the US gallery next year. And right now, there's no change to our '25 guidance.

是的，你想考慮一下，是的，當然，是的，所以我們對這兩個機會都感到興奮，正如 Josh 為 Quest 和 TRICARE 所做的詳細闡述。Quest 將使測試可直接透過其係統訂購。患者無需攜帶試劑盒去抽血等。正如 Josh 所說，TRICARE 非常興奮並與付款人合作實施保險。作為指導，我們為明年的美國畫廊考慮了一些事情和機會。目前，我們的 25 年指引沒有改變。

Got it, thank you. And then, I guess just following up on Doug's question on the MSA legislation. So, I believe there was a December bill that mentioned reimbursement beginning in 2029 and then a more recent bill from February in the Senate, which had reimbursement beginning in 2028. Could you share thoughts on how these timelines align for expectations? And then on a related note, I believe the bill in February also mentioned reimbursement in line with multi-target stool screen tests. So does that potential reimbursement rate for MSA tests, also align with your expectations?

知道了，謝謝。然後，我想只是跟進 Doug 關於 MSA 立法的問題。因此，我相信 12 月的一項法案提到了從 2029 年開始報銷，而參議院 2 月的一項最新法案也提到了從 2028 年開始報銷。您能否就這些時間表如何與預期保持一致發表您的看法？然後，在相關說明中，我相信二月的法案也提到了根據多目標糞便篩檢測試進行報銷。那麼 MSA 測試的潛在報銷率是否也符合您的預期？

Thank you.

謝謝。

Yeah, so I, on the first piece in terms of the timeline, the piece in December was what was negotiated back and forth, and then, what's currently in there just resetting back to the beginning position. So as it gets reintroduced, it's back into the beginning starting position for the bill, the pricing. The pricing is referenced in that as well, similar to the current current market for stool-based testing, so that that seems to be accurate.

是的，所以就時間軸的第一部分而言，12 月的部分是經過反覆協商的，然後，目前的內容就重置回了開始的位置。因此，當它重新引入時，它就回到了帳單和定價的起始位置。其中也參考了定價，類似於目前基於糞便的檢測的市場，因此這似乎是準確的。

Sorry, just to tie it back to the conversation on COGS and margins, we've, we were saying we've implemented this new version in contemplation of population scale, so we've contemplated that pricing and in that in that endeavor.

抱歉，只是為了將其與關於銷貨成本和利潤的討論聯繫起來，我們說過，我們已經考慮到人口規模實施了這個新版本，因此我們已經考慮了定價並為此付出了努力。

Thank you, I appreciate the color.

謝謝，我很欣賞這個顏色。

Subbu Nambi, Guggenheim Partners.

蘇布南比 (Subbu Nambi)，古根漢合夥人事務所。

Hey guys, it's Thomas on for Subbu. Thanks for taking our questions. Just to start maybe one on PATHFINDER 2, curious to know what success looks like for you guys for that study. Any color on, what sort of readout you're looking for, maybe any endpoints, as well, and then obviously acknowledging it's early days, when would you call it, say, if it wasn't playing out to expectations?

嘿夥計們，我是 Thomas，為 Subbu 效力。感謝您回答我們的問題。也許只是開始研究 PATHFINDER 2，好奇想知道你們在該研究中會取得怎樣的成功。有任何細節嗎？您正在尋找什麼樣的讀數？也許還有任何終點？然後顯然承認現在還為時過早，如果它沒有達到預期，您會什麼時候稱它為成功？

Josh, you want to jump in on that one?

喬希，你想加入這個嗎？

Sure. So as you remember, PATHFINDER 2 is a US study, single-arm interventional trial where we're really evaluating the safety and the performance of Galleri in an adult US population over the age of 50, with elevated risk for cancer. So really the main endpoints of that study are going to be traditional measures of test performance.

當然。所以您還記得，PATHFINDER 2 是一項美國研究，單臂介入試驗，我們實際上正在評估 Galleri 在 50 歲以上患癌症風險較高的美國成年人口中的安全性和表現。因此，研究的主要終點實際上是傳統的測驗成績衡量標準。

The diagnostic evaluation, the workups, the specificity, sensitivity, predicted values, and then on the safety issue, obviously, the traditional safety measures of complications associated with workups and whether individuals continue to get their standard of care screening. And that's all very similar to what was in PATHFINDER 1, as well. And so, we will read that study out and it will be part of our final modular submission to the FDA in the first half of '26.

診斷評估、檢查、特異性、敏感性、預測值，然後是安全性問題，顯然是與檢查相關的併發症的傳統安全措施，以及個人是否繼續接受標準護理篩檢。這一切也與 PATHFINDER 1 中的內容非常相似。因此，我們將宣讀這項研究，它將成為我們在 26 年上半年向 FDA 提交的最終模組的一部分。

And so, I guess that probably answers your question.

所以，我想這可能回答了你的問題。

Great, that's helpful. And then, just one follow-up on a separate note, on cash, as you closed out 2024, can you speak to, what cash preservation initiatives may have done to efforts to get more payer coverage, there's the recent announcement that you said on the call, but any new color on longer term impacts there? Thanks.

很好，很有幫助。然後，關於現金，您在 2024 年結束之際，能否談談現金保存舉措可能對獲得更多付款人保障的努力產生哪些影響，您在電話會議上提到了最近的公告，但對於長期影響，您有什麼新的說明嗎？謝謝。

Yeah, no change from what we communicated to JP Morgan and prior the restructuring we completed last year before last year, gives us cash runway to '28, with cash per decreasing, over the coming years as we get there.

是的，與我們與摩根大通溝通的內容以及去年完成的重組相比沒有任何變化，這為我們提供到了 28 年的現金儲備，隨著我們到達那個目標，未來幾年現金儲備將會減少。

Awesome. Thanks, guys.

驚人的。謝謝大家。

[Kyle Nixon, Canaccord].

[凱爾·尼克松，Canaccord]。

Hi everyone, this is Alex one for Kyle Nixon. So obviously, a major topic of discussion has been the company's spending and burn profile. Obviously, there continues to be a lot of uncertainty related to MSA legislation, which was you know noted earlier in the call. So if your internal FDA submission and approval timelines are ultimately either meaningfully elongated or shortened, how could this impact your earlier cash burn? Thanks.

大家好，我是亞歷克斯 (Alex)，為凱爾·尼克森 (Kyle Nixon) 做介紹。因此顯然，討論的一個主要主題是公司的支出和燒錢狀況。顯然，MSA 立法相關的不確定性仍然存在，這一點我們在先前的通話中已經提到過。因此，如果您的內部 FDA 提交和批准時間最終被大幅延長或縮短，這會對您先前的現金消耗產生什麼影響？謝謝。

Yeah, so, currently our plans for FDA PMA submission are the first half of '26. We see cash runway into 2028, so we believe we've built in some cushions, some flexibility there, to cover any sort of delay if that were to happen. Today, sitting here confidently though with our first half of '26 timeline. Bob, Josh, anything else you guys want to add?

是的，目前我們向 FDA PMA 提交的計劃是在 26 年上半年。我們預計現金流將持續到 2028 年，因此我們相信我們已經建立了一些緩衝和靈活性，以應對如果發生這種情況時可能出現的任何延誤。今天，我們滿懷信心地坐在這裡，回顧 26 年上半年的時間表。鮑伯、喬希，你們還有什麼要補充的嗎？

Yeah, no, I just think the, as Aaron mentioned, we have built in some buffer, we wanted part of choosing to do the restructure and drive our cash runway into 2028 was to give us some level of flexibility. So we believe that's built in.

是的，不，我只是認為，正如 Aaron 所提到的，我們已經建立了一些緩衝，我們希望選擇重組並將我們的現金跑道推至 2028 年的部分目的是為我們提供一定程度的靈活性。因此我們相信這是內在的。

Got it, thank you. And one quick follow-up. So in January 2025, President Trump announced Oracle open AI and SoftBank joint forces to launch Stargate, essentially a lot of funding going towards AI and Larry Ellison actually noted early cancer detection and AI could team up, join forces over time. I was curious if any of this -- any of this news-impacted results in one cue at all thus far? Thank you.

知道了，謝謝。還有一個快速的後續行動。因此在 2025 年 1 月，川普總統宣布甲骨文開放 AI，並與軟銀聯手啟動星際之門，大量資金將用於 AI，而拉里·埃里森實際上也指出，早期癌症檢測和 AI 可以合作，隨著時間的推移共同發揮作用。我很好奇，到目前為止，這些受新聞影響的結果是否有任何線索？謝謝。

Yeah, so we think that's more about longer term opportunity. It was great to see -- it's great to see cancer in the forefront as the killer and the killer application for AI that was called out in that press conference, but in terms of Q1 impact, I don't think we'll see anything there.

是的，所以我們認為這更多的是一個長期機會。很高興看到——很高興看到癌症成為新聞發布會上提到的殺手級人工智慧應用的焦點，但就第一季的影響而言，我認為我們不會看到任何東西。

Got it. Thank you.

知道了。謝謝。

Thank you. There are no further questions at this time. I will now turn the call back to Grail for closing remarks.

謝謝。目前沒有其他問題。現在我將電話轉回給 Grail，請他作最後發言。

So thank you everyone for joining the call today.

感謝大家今天的電話會議。

Ladies and gentlemen, this concludes the call. You may now disconnect.

女士們、先生們，本次通話到此結束。您現在可以斷開連線。