Belite Bio Inc (BLTE) 2025 Q2 法說會逐字稿

Ladies and gentlemen, thank you for joining us, and welcome to the Belite Bio second-quarter 2025 earnings call. (Operator Instructions) I will now hand the call over to [Sophie Hunt] Please go ahead.

女士們，先生們，感謝你們的到來，歡迎參加 Belite Bio 2025 年第二季財報電話會議。（接線生指示）我現在將電話交給 [Sophie Hunt] 請繼續。

Good afternoon, everyone. Thank you for joining us. On the call today are Dr. Tom Lin, Chairman and CEO of Belite Bio; Dr. Nathan Mata, Chief Scientific Officer; Dr. Hendrik Scholl, Chief Medical Officer; and Hao-Yuan Chuang; Chief Financial Officer.

大家下午好。感謝您加入我們。今天參加電話會議的有 Belite Bio 董事長兼執行長 Tom Lin 博士、首席科學官 Nathan Mata 博士、首席醫療官 Hendrik Scholl 博士和財務長 Hao-Yuan Chuang。

Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. We encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now I'll turn the call over to Dr. Lin.

在我們開始之前，請允許我指出，我們將根據我們當前的期望和信念做出前瞻性的陳述。這些聲明受一定風險和不確定性的影響，實際結果可能有重大差異。我們鼓勵您查閱我們提交給美國證券交易委員會的文件中討論的風險因素以獲取更多詳細資訊。現在我將電話轉給林醫師。

Thank you for joining today's call to discuss our second-quarter 2025 financial results. We have made excellent progress in the quarter towards advancing the narrowband in patients living with Stargardt disease and Geographic Atrophy.

感謝您參加今天的電話會議討論我們的 2025 年第二季財務業績。本季度，我們在治療 Stargardt 病和地圖狀萎縮症患者的窄帶治療方面取得了巨大進展。

For those who are new to our story, the narrowband is a first-in-class oral therapy intended to reduce the accumulation of toxic vitamin A byproducts, which is implicated in the progression of retinal lesions in patients with Stargardt disease and Geographic Atrophy.

對於剛了解我們故事的人來說，窄帶是一種一流的口服療法，旨在減少有毒維生素 A 副產物的積累，這種副產物與 Stargardt 病和地圖狀萎縮患者的視網膜病變進展有關。

We believe this approach will be effective in slowing our holding lesion growth, which would ultimately preserve vision. To give you some perspective on the importance of this potential therapy, Tinlarebant has been granted breakthrough therapy rare pediatric disease and Fast Track designations in the US and (inaudible); designation in Japan. There has also been granted orphan drug designation in the US, Europe and Japan.

我們相信這種方法將有效減緩病變的生長，最終保住視力。為了讓您對這種潛在療法的重要性有所了解，Tinlarebant 已在美國獲得突破性治療罕見兒科疾病資格和快速通道資格，並在日本獲得（聽不清楚）資格。美國、歐洲和日本也授予了孤兒藥稱號。

We believe this speaks to the significant unmet need for both indications as currently, there is no approved treatment for Stargardt disease and no approved oral treatment for Geographic Atrophy. As importantly, we are uniquely positioned to address these unmet needs as we are already in global Phase 3 trials for both indications. So with that, let me provide a high level overview of the recent progress we have made.

我們認為，這說明這兩種疾病都存在著巨大的未滿足需求，因為目前還沒有批准治療 Stargardt 病的藥物，也沒有批准治療地圖狀萎縮的口服藥物。同樣重要的是，我們在滿足這些未滿足的需求方面具有獨特的優勢，因為我們已經針對這兩種適應症進行了全球 3 期試驗。因此，讓我對我們最近的進展進行一個高層次的概述。

We have two studies underway with Tinlarebant in patients living with Stargardt disease. These are the Phase III (inaudible) trial and the Phase 2/3 DRAGON II trial. As part of the Phase 3 driven trial, we were pleased to announce earlier in the year that the Data Safety Monitoring Board has completed its interim analysis and recommended that the trial proceed without a sample size increase or modifications. They also recommended that we submit the data for further regulatory review for drug approval.

我們正在對患有 Stargardt 病的患者進行兩項有關 Tinlarebant 的研究。這些是第三階段（聽不清楚）試驗和第二/三階段 DRAGON II 試驗。作為第三階段試驗的一部分，我們很高興在今年稍早宣布，資料安全監測委員會已經完成了中期分析，並建議試驗繼續進行，無需增加樣本量或進行修改。他們還建議我們提交數據以供進一步監管審查以獲得藥品批准。

As a result, the FDA granted Tinlarebant Breakthrough Therapy designation, and we remain on track to complete the study in Q4 this year. The DRAGON II trial also continues to be on track. We have enrolled 17 of our targeted enrollment of approximately 60 subjects, including about 10 Japanese subjects.

因此，FDA 授予 Tinlarebant 突破性療法認定，我們仍有望在今年第四季完成這項研究。DRAGON II 試驗也持續順利進行。我們計劃招生約60名學生，目前已招收17名，其中包括約10名日文學生。

The data from the Japanese subjects is it tended to expedite a new drug application in Japan where we have already been granted a Pioneer Drug Designation. In geographic atrophy, I'm pleased to share that we recently completed enrollment of our global Phase 3 study with 529 subjects enrolled.

來自日本受試者的數據表明，它傾向於加快在日本的新藥申請，我們已經獲得了先鋒藥物稱號。在地理性萎縮方面，我很高興地告訴大家，我們最近完成了全球第 3 階段研究的招募，共有 529 名受試者入組。

We recently also raised $15 million in gross proceeds in a registered direct offering on August 8. To summarize, we made excellent progress against our key milestones in the first half of the year. We are looking to carry this momentum into the second half of the year. Our balance sheet is also strong with full years of cash runway. We remain well positioned to advance Tinlarebant as potentially the first oral treatment for people living with degenerative baton disease.

我們最近也於 8 月 8 日透過註冊直接發行籌集了 1500 萬美元的總收益。總而言之，我們在上半年的關鍵里程碑方面取得了優異的進展。我們希望將這股勢頭延續到下半年。我們的資產負債表也很強勁，擁有充足的現金流。我們仍處於有利地位，可以推動 Tinlarebant 成為治療退化性淋巴細胞疾病患者的首個口服藥物。

I'll now turn over the presentation to Hao-Yuan. Hao-Yuan?

現在我將演講交給郝元。浩源？

Thank you, Tom. For Q2 2025, we had R&D expenses of $11 million compared to $9.1 million for the same period last year. The increase was mainly due to higher pass-through expenses related to the PHOENIX trial and manufacturing expenses which was partially offset by lower DRAGON trial expenses and development milestone payment for the completion of the Phase 2 trial in 2024.

謝謝你，湯姆。2025 年第二季度，我們的研發費用為 1,100 萬美元，去年同期為 910 萬美元。成長的主要原因是與 PHOENIX 試驗和製造費用相關的轉嫁費用增加，但被 DRAGON 試驗費用減少和 2024 年完成第 2 階段試驗的開發里程碑付款部分抵消。

Also due to an increase in share-based compensation expenses. Regarding G&A expenses, we had G&A expenses of $6.5 million compared to $1.4 million for the same period last year. The increase was mainly due to an increase in share-based compensation expenses.

這也歸因於股權激勵費用的增加。至於一般及行政費用，我們的一般及行政費用為 650 萬美元，去年同期為 140 萬美元。成長的主要原因是股權激勵費用增加。

Overall, we had a net loss of $16.3 million compared to a net loss of $9.5 million for the same period last year. One thing to note is that as the majority of the increase of the expenses came from the share-based compensation, which was about $7.6 million and was not cash related. The operating cash outflow was only about $3.6 million. At end of Q2, we had $149.2 million in cash liquidity fund, time deposit and US treasury bills.

整體而言，我們的淨虧損為 1,630 萬美元，而去年同期的淨虧損為 950 萬美元。需要注意的一點是，費用的增加大部分來自股權激勵，約 760 萬美元，與現金無關。經營現金流出僅約360萬美元。截至第二季末，我們擁有 1.492 億美元的現金流動資金、定期存款和美國國庫券。

We also raised $15 million in gross proceeds in the registered direct offering on August 8. We still expect full years of cash run rate without considering the commercialization costs and expect to be able to complete all three Phase 3 trials with our current cash.

我們還在 8 月 8 日的註冊直接發行中籌集了 1500 萬美元的總收益。我們仍然預計在不考慮商業化成本的情況下全年的現金運行率，並預計能夠用我們目前的現金完成所有三個第三階段試驗。

Thank you. Back to you, operator.

謝謝。回到你這裡，接線生。

Thank you. We will now begin the question-and-answer session. (Operator Instructions)

謝謝。我們現在開始問答環節。（操作員指示）

Boris Peaker, Titan Partners.

鮑里斯‧皮克（Boris Peaker），泰坦合夥公司（Titan Partners）。

Can you guys hear me? Just want to confirm the line is live.

你們聽得到我說話嗎？只是想確認線路是否正常。

(multiple speakers)

（多位發言者）

Congratulations on the progress. I guess my first question is, what is the status of the FDA discussion regarding the interim data that from the DRAGON trial just trying to get a sense of that could potentially be a trigger for filing BLA. And if it's not NDA in this case and if it's not, what data would you think you'd need to actually get from DRAGON 2 study, one-year follow-up, two-year follow-ups? How long prior to an NDA filing?

恭喜你取得進展。我的第一個問題是，FDA 關於 DRAGON 試驗中期數據的討論情況如何？我只是想了解一下，這些數據可能會成為提交 BLA 的觸發因素。如果在這種情況下它不是 NDA，您認為您實際上需要從 DRAGON 2 研究、一年追蹤、兩年追蹤中獲得哪些數據？提交保密協議 (NDA) 之前需要等待多久？

Thank you. So I can take this one. So we've made so we drilled the breakthrough based on the IA data we've met with the FDA, and so given the IA criteria was met with all subjects achieved 12 months on study, majority of subjects have already reached 15 months. So I mean, we could try for accelerated approval, but that will still require a confirmatory follow-up study.

謝謝。所以我可以接受這個。因此，我們根據向 FDA 提交的 IA 數據取得了突破，鑑於 IA 標準得到滿足，所有受試者的研究都達到了 12 個月，大多數受試者已經達到了 15 個月。所以我的意思是，我們可以嘗試加速批准，但這仍然需要確認性的後續研究。

So the FDA recommended that we complete the 24-month study, which we are about to complete coming up in September, October. And so we will submit that final data, and they will possibly be a single study approval based on a robust statistical significance.

因此 FDA 建議我們完成這項為期 24 個月的研究，我們將在 9 月、10 月完成。因此，我們將提交最終數據，並且它們可能會基於穩健的統計意義獲得單一研究的批准。

Got it. So just to confirm, so the possibility just filing on DRAGON 1, and using the bases and then driving to and when would you actually know that DRAGON 1 in and of itself is sufficient for approval?

知道了。因此，只是為了確認一下，是否有可能僅在 DRAGON 1 上提交申請，然後使用基地並開車前往，什麼時候您才能真正知道 DRAGON 1 本身是否足以獲得批准？

So I think based on the FDA's recommendation, that the p value will be robust enough, and we believe that we're on track to meet the criteria.

因此，我認為根據 FDA 的建議，p 值將足夠穩健，我們相信我們能夠滿足標準。

Got it. Okay. I appreciate that. Maybe if I could squeeze in just one question on GA, now that the PHOENIX trials completed enrollment, can you discuss if there's going to be an interim analysis let's say, a year from now or so or any other timing around the data readouts?

知道了。好的。我很感激。也許如果我可以擠出一個關於 GA 的問題，那麼現在 PHOENIX 試驗已經完成了招募，您能否討論一下是否會進行中期分析，比如說，一年後或數據讀數的任何其他時間？

Yeah, sure. So there will be (inaudible) I think based on the overall regulatory strategy right now, I don't think I have a time line with me, but it will be some we will be somewhere halfway during the similarly to the Stargardt, I just don't have the details, but it will be halfway mark.

是的，當然。因此會有（聽不清楚）我認為基於目前的整體監管策略，我不認為我有時間表，但它會是一些我們將在某個時間點進行，類似於 Stargardt，我只是沒有細節，但它會是一半的時間點。

Got it. Well, I appreciate you taking my questions, and congrats on progress again.

知道了。好吧，感謝您回答我的問題，並再次祝賀您取得進展。

Thank you so much.

太感謝了。

Bruce Jackson, Benchmark.

布魯斯傑克遜，基準。

Hi, thank you for taking my questions. Can you hear me okay?

你好，謝謝你回答我的問題。你聽見我說話嗎？

Yeah.

是的。

Okay, super. So you got the breakthrough therapy designation. And have you discussed with the FDA yet if there's a route to accelerated approval?

好的，太棒了。所以你獲得了突破性療法的稱號。您是否與 FDA 討論過是否有加速審批的途徑？

Oh, yeah. Yes. So there was a route for accelerated approval, but the FDA, they recommended since that we are we have a majority of the patients completing the 15-month time point already. So it will be long to reach the 24 months. And then given that the accelerate approval will still require a second study they were recommended for a single study. I mean, they recommended for path single study path with robust statistical significance.

哦，是的。是的。因此，存在加速審批的途徑，但 FDA 建議，由於我們大多數患者已經完成了 15 個月的時間點。因此要達到24個月還需要很長時間。然後，考慮到加速批准仍然需要進行第二項研究，他們被建議進行單一研究。我的意思是，他們推薦具有強大統計意義的單一學習路徑。

Okay. And then my second question is about educating the medical community about your drug. So are there any upcoming presentations or data readouts that we can look to near term, not just the completion or the follow-up as of the study, anything on an interim basis.

好的。我的第二個問題是關於向醫學界普及你們的藥物的知識。那麼，是否有任何即將進行的演示或數據讀數可供我們近期查看，而不僅僅是研究的完成或後續行動，任何暫時的情況。

Look, I guess that our time line is very tight that we are expecting. So we ran the time line with the FDA and they acknowledge that we'll be submitting around first half sorry, first half of next year, and they want us to be to remain confidential on revealing any efficacy data.

看，我想我們的時間表已經非常緊湊了。因此，我們與 FDA 制定了時間表，他們承認我們將在明年上半年左右提交，對不起，是明年上半年，他們希望我們對透露任何功效數據保密。

So we were planning on presenting the (inaudible) data at AAO, which is roughly about late October. But given that we'll be submitting very soon after that, so the FDA would prefer that we stay confidential on the data.

因此，我們計劃在 AAO 上展示（聽不清楚）數據，時間大約在 10 月下旬。但考慮到我們很快就會提交，因此 FDA 希望我們對資料保密。

Well, Bruce, first I think I can add that. So once we have the final 24-month data, we will announce that. But you wouldn't need to wait until the submission to see the data. But before that, we will not reveal interim data.

好吧，布魯斯，首先我想我可以補充一點。因此，一旦我們獲得最終的 24 個月數據，我們就會宣布。但您不需要等到提交後才能看到資料。但在此之前，我們不會透露中期數據。

Okay. That's it for me. Thank you.

好的。對我來說就是這樣。謝謝。

Thank you.

謝謝。

Jennifer Kim, Cantor.

珍妮佛金（Jennifer Kim），領唱。

Hi, thanks for taking my questions. Can you hear me?

你好，謝謝你回答我的問題。你聽得到我嗎？

Yes.

是的。

All right. Maybe to start with DRAGON, can you remind us what the exact timing of data will be after the trial finishes in the fourth quarter? And then how and what data will be communicated and what you're hoping to show in terms of efficacy to support filing? Maybe we can start --

好的。也許從 DRAGON 開始，您能否提醒我們第四季度試驗結束後數據的確切時間是什麼？那麼，將如何傳達數據、傳達哪些數據，以及您希望展示哪些功效來支持備案？也許我們可以開始--

Nathan, probably best that you have answered this question.

內森，你最好已經回答了這個問題。

Yeah, as you know, we're looking at the change of atrophic lesion growth, right? So lesion growth rate over time. in all subjects to all available time points. So we're looking for significance between placebo and treatment in terms of changing the trajectory of lesion growth. So that's what we expect to show the agency is a strategically significant difference in lesion growth rates.

是的，如您所知，我們正在觀察萎縮性病變生長的變化，對嗎？因此，所有受試者在所有可用時間點的病灶生長率都會隨時間而改變。因此，我們正在尋找安慰劑和治療在改變病灶生長軌跡的顯著性。因此，我們希望向該機構展示病變成長率具有戰略意義的差異。

And that is what you need for approval. It's the same endpoint that was used in Geographic Atrophy to get the two intravitreal drugs approved. So it's basically the same metric.

這就是您獲得批准所需要的。這與地圖狀萎縮症中用於獲得兩種玻璃體內注射藥物批准的終點相同。所以基本上是相同的指標。

Okay. And then my second question is just for PHOENIX. What is the latest dropout rate you've seen to date? Is it still in the 20% range? And what can we expect in terms of the depth of data in an interim analysis?

好的。我的第二個問題是關於 PHOENIX 的。到目前為止，您看到的最新輟學率是多少？它還在20%的範圍內嗎？那麼，對於中期分析的資料深度，我們可以期待什麼呢？

(multiple speakers) we think expected range. The depth of the interim, we have not finalized the interim design yet. So we will announce that once we know.

（多位發言者）我們認為預期範圍。臨時的深度，我們還沒有最終確定臨時設計。一旦我們知道了，我們就會宣布。

Thank you.

謝謝。

Yi Chen, H.C. Wainright.

陳毅，H.C.溫賴特。

Thank you for taking my questions. So for the DRAGON 2 trial, what is the current estimate timeline for reaching the target enrollment of 60 patients? Is the current enrollment speed meeting your expectation?

感謝您回答我的問題。那麼對於 DRAGON 2 試驗，目前預計達到 60 位患者的目標入組時間是什麼時候？目前的招生速度符合你的預期嗎？

Yeah, I can take that question. So we initially launched DRAGON 1, as I drag into Japan. And now we are in process of expanding into additional countries, which we expect will accelerate enrollment. We strategically timed driven to not to compete with DRAGON 1, so that we can speed up the completion of DRAGON 1. And of course, in the case if the DSMB recommends further sample size addition then that wouldn't slow down the completion of DRAGON 1.

是的，我可以回答這個問題。因此我們最初推出了DRAGON 1，作為我拖入日本的舉措。目前，我們正在向其他國家擴張，預計這將加速招生。我們策略性地安排時間，不與DRAGON 1競爭，以便加速DRAGON 1的完成。當然，如果 DSMB 建議進一步增加樣本量，那麼這不會減慢 DRAGON 1 的完成速度。

Since that the DSMB that recommended that we wouldn't need to add every sample size. So we're kind of speeding up DRAGON 2. So we kind of purposely stage DRAGON 2 to not compete with DRAGON 1. So even though it's slower than what we expected, but that is because of that DRAGON 2 would compete with DraAgon 1, so I think we are still on time. I think the expectation of completing the enrollment probably will take, I would say --

因為 DSMB 建議我們不需要添加每個樣本大小。因此我們正在加速 DRAGON 2 的進程。因此，我們特意安排了 DRAGON 2，以避免與 DRAGON 1 競爭。因此，儘管它比我們預期的要慢，但這是因為 DRAGON 2 將與 DraAgon 1 競爭，所以我認為我們仍然按時完成。我認為完成入學的期望可能需要--

End of this year.

今年年底。

Yeah, end of this year. Yeah.

是的，今年年底。是的。

Understood. Thank you. And I noticed that your operating expenses continue to rise in the second quarter. Can you talk about the primary drivers for operating expenses, and whether this kind of level of expensing is sustainable as you approach key clinical milestones later this year?

明白了。謝謝。而且我注意到你們第二季的營運費用持續上升。您能談談營運費用的主要驅動因素嗎？以及當您在今年稍後接近關鍵臨床里程碑時，這種費用水平是否可持續？

Yeah, Sure. First of all, the operating expense does include a majority of the expenses come from the share based compensation. So those are not cash related. And is it a little bit hard to really have a so-called precise forecast about that because they are purely based on the valuation of the options and the probability of reaching those milestones. Many of our ESOP is going to be related for development milestone. So purely based on the probability.

是的，當然。首先，營業費用確實包括了大部分來自股權激勵的費用。所以這些與現金無關。但實際上，對此做出所謂的精確預測是否有點困難，因為它們純粹基於選擇權的估值和達到這些里程碑的可能性。我們的許多員工持股計畫都將與發展里程碑相關。所以純粹基於機率。

So instead of time, you only get those vested so after we reached those milestones. So if you remove those, then the cash outflow is actually pretty close to the Q1 2025. This year and next year, we do expect to have higher current cash burn, given that we do expect to reach several milestones on both -- through the both to three Phase 3 studies.

因此，您無需等待時間，只有在我們達到這些里程碑之後，您才能獲得這些既得利益。因此，如果刪除這些，那麼現金流出實際上非常接近 2025 年第一季。今年和明年，我們確實預計目前的現金消耗會更高，因為我們確實希望透過兩項到三項第三階段的研究達到幾個里程碑。

So this year, next year, we probably expect to have cash outflow of around $40 million to $45 million for two years, this and next year. And then you will dial down a lot starting from three years from now. So that's why we still expect four years of cash flow our way.

因此，今年和明年，我們預計今年和明年兩年的現金流出量約為 4,000 萬至 4,500 萬美元。然後從三年後開始，你就會減少很多。這就是為什麼我們仍然期望四年內會有現金流。

Got it. Thank you.

知道了。謝謝。

Thank you.

謝謝。

(Operator Instructions) Michael Okunewitch, Maxim Group.

（操作員指示）Michael Okunewitch，Maxim Group。

Hey guys, thank you so much for taking my questions today, and congrats on all the great progress. So I just wanted to follow up a little bit on the single pivotal design. In particular, if under the current FDA because there have been a lot of changes over the past several months, if you received any communication from the current admin that confirms that single pivotal for full approval, perhaps around when you got breakthrough designation.

嘿，大家好，非常感謝你們今天回答我的問題，並祝賀你們取得的巨大進步。所以我只是想稍微跟進一下單一關鍵的設計。特別是，如果在當前的 FDA 下，因為過去幾個月發生了很多變化，如果您收到當前管理員的任何通信，確認單一關鍵的全面批准，也許在您獲得突破性稱號的時候。

I think we with the FDA after submitting the (inaudible) data, which we got breakthrough status. I think the path forward is very clear for us and very straightforward for a single study if we met the statistical significance -- robust statistical significance that is (inaudible) of less than 0.01, then we have a single study approval path.

我認為我們向 FDA 提交（聽不清楚）資料後，就獲得了突破性進展。我認為前進的道路對我們來說非常清晰，對於單一研究來說也非常簡單，如果我們滿足統計意義——穩健的統計意義（聽不清楚）小於 0.01，那麼我們就有一條單一的研究批准路徑。

All right. Thank you. And then just a follow-up. Do you have a sense of what sort of scale of a commercial for us, you would need to actually bring this to market? Just now you do have four years of run line, it seems like you're pretty well positioned to reach approval here?

好的。謝謝。然後只是後續行動。您是否知道我們需要多大的商業規模才能將其真正推向市場？現在您確實有四年的跑線，看起來您已經做好了獲得批准的準備了？

(multiple speakers) --

（多位發言者）——

The current cash burn that we forecast for four years a runway does not include the full skill set of the commercialization costs. which we are in progress of (technical difficulty) So we will build the budget once we confirm.

我們預測四年的現金消耗並不包括商業化成本的全部技能。我們正在進行中（技術難度），因此一旦我們確認，我們將製定預算。

All right. Thank you very much for taking my questions, and once again, congrats on all the great progress.

好的。非常感謝您回答我的問題，再次恭喜您取得的巨大進步。

Thank you very much.

非常感謝。

Marc Goodman, Leerink Partners.

馬克古德曼（Marc Goodman），Leerink Partners。

Hi, can you hear me there?

嗨，你聽得到我說話嗎？

Yeah. Yes.

是的。是的。

Hey guys, so I guess what I want to know is we get the data released in this press release that you were talking about late this year, early next year. We get good news. How soon after will we be able to file? What are the gating issues between that press release and the filing, specifically talk about CMC as well as long-term safety data?

嘿夥計們，我想知道的是，我們能得到你們在今年年底或明年年初發布的新聞稿中的數據嗎？我們得到了好消息。我們多久之後可以提交申請？新聞稿和文件之間的門控問題是什麼，特別是關於 CMC 以及長期安全資料？

So I can answer this question. So the first one, long-term safety data, I think we will need a (inaudible) of 300, I believe we've acquired it. So Hendrik, can you help me out on the GA study we will have enough safety subject, right?

所以我可以回答這個問題。因此，第一個，長期安全數據，我認為我們需要 300（聽不清楚），我相信我們已經獲得了它。那麼亨德里克，你能幫我完成 GA 研究嗎，我們會有足夠的安全主題，對嗎？

Exactly, Tom, right? So the requirement is that we would have 300 subjects that would be 12 months on the drug. And including our PHOENIX trial, we easily will have that by the first quarter of next year.

確實如此，湯姆，對吧？因此，我們的要求是，有 300 名受試者服用該藥物 12 個月。包括我們的 PHOENIX 試驗在內，我們將很容易在明年第一季實現這一目標。

Sorry, Marc, what was your other question,?

抱歉，馬克，你還有什麼問題？

So Basically, you could use the safety from both studies you're saying include into that's why you're here. And the other was the CMC.

所以基本上，你可以利用你所說的兩項研究中的安全性，這就是你在這裡的原因。另一個是中央軍委。

So we have ongoing discussion with the CMC with the FDA. So far, we are on track. So it will probably be another discussion with the FDA before we submit.

因此，我們正在與 CMC 和 FDA 進行持續討論。到目前為止，一切進展順利。因此，在提交之前我們可能還需要與 FDA 進行另一次討論。

But just from us, where are we on that? And just where is the whole --

但就我們而言，我們在這方面處於什麼位置？整個--

We are on the registration batch that's required for NDA.

我們正處於保密協議 (NDA) 所需的註冊批次中。

Right. Okay. Thank you.

正確的。好的。謝謝。

Thanks, Marc.

謝謝，馬克。

There are no further questions at this time. This concludes today's call. Thank you for joining. You may now disconnect.

目前沒有其他問題。今天的電話會議到此結束。感謝您的加入。您現在可以斷開連線。