Quoin Pharmaceuticals Ltd (QNRX) 2023 Q2 法說會逐字稿

Good morning. Welcome to Quoin Pharmaceuticals Limited second-quarter fiscal results and business update conference call. (Operator Instructions) Please note this event is being recorded.

早上好。歡迎參加 Quoin Pharmaceuticals Limited 第二季度財務業績和業務更新電話會議。 （操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Gordon Dunn, CFO. Please go ahead.

我現在想將會議交給首席財務官戈登·鄧恩 (Gordon Dunn)。請繼續。

Thank you, and good morning. We appreciate you joining us on today's conference call. With me on the call are Dr. Michael Myers, CEO; and Denise Carter, COO.

謝謝你，早上好。我們感謝您參加今天的電話會議。與我一起參加電話會議的是首席執行官邁克爾·邁爾斯 (Michael Myers) 博士；和首席運營官丹尼斯卡特。

We are pleased to provide an update on our progress for the second quarter of 2023, as well as discussing our Q2 2023 financial results. Please note that our operational and financial results press release is now available on Quoin's website.

我們很高興提供 2023 年第二季度進展的最新信息，並討論 2023 年第二季度的財務業績。請注意，我們的運營和財務業績新聞稿現已發佈在 Quoin 網站上。

In keeping with our normal procedure, to begin -- Michael will begin a corporate, clinical, and operational update, following which I will review our financial results. I will then hand the call back to Michael for closing comments. We will also be pleased to answer any questions at the end of the call.

按照我們的正常程序，首先，邁克爾將開始公司、臨床和運營方面的更新，隨後我將審查我們的財務業績。然後我會將電話轉回給邁克爾以徵求結束意見。我們也很樂意在通話結束時回答任何問題。

Before we begin, I'd like to remind everyone that statements made during this conference call may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these forward-looking statements. For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC.

在開始之前，我想提醒大家，本次電話會議中的陳述可能包括 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述，其中涉及可能導致實際結果存在重大差異的風險和不確定性這些前瞻性陳述明示或暗示的信息。有關此類風險和不確定性的更多信息，請參閱該公司向 SEC 提交的文件中概述的風險因素。

Any forward-looking statements are made only as of today, and we disclaim any obligation to update these forward-looking statements other than as required by law. Please see the Forward-Looking Statements section in our financial results release issued this morning for more information.

任何前瞻性陳述僅截至今日作出，除法律要求外，我們不承擔任何更新這些前瞻性陳述的義務。請參閱今天上午發布的財務業績新聞稿中的前瞻性陳述部分，了解更多信息。

It is now my pleasure to turn the call over to our CEO, Michael Myers. Michael?

現在我很高興將電話轉給我們的首席執行官邁克爾·邁爾斯。邁克爾？

Thank you, Gordon, and good morning, everyone. On our last call, I reported on the very strong start Quoin has had to 2023. Today, I'm very pleased to announce that this momentum carried into and through the second quarter.

謝謝戈登，大家早上好。在我們上次的電話會議上，我報告了 Quoin 到 2023 年的強勁開局。今天，我很高興地宣布，這種勢頭將延續到第二季度。

On May 24, we announced that our open-label Netherton syndrome clinical trial had achieved 50% recruitment, and additional subjects have been enrolled since that. You may recall that we only dosed the first subject in this study in March of this year. So we are very pleased with the pace of recruitment overall.

5 月 24 日，我們宣布開放標籤 Netherton 綜合徵臨床試驗已實現 50% 的招募，此後又陸續招募了更多受試者。您可能還記得，我們在今年 3 月份才對本研究中的第一個受試者進行了給藥。因此，我們對總體招聘進度感到非常滿意。

Our other Netherton syndrome clinical study is on track to have recruited a majority of subjects this month. And it is extremely encouraging how high the interest levels continues to be for participation in both studies. We announced today the availability of data from the first patient to complete our open-label clinical study, and I will provide more commentary on this later in the call.

我們的另一項內瑟頓綜合徵臨床研究有望在本月招募大部分受試者。令人非常鼓舞的是，人們對參與這兩項研究的興趣持續高漲。我們今天宣布獲得了第一位完成開放標籤臨床研究的患者的數據，我將在稍後的電話會議中對此提供更多評論。

Also, during the quarter, we made substantial progress on our plans to initiate additional Netherton syndrome clinical studies, including one in a pre-identified cohort of approximately 20 Netherton patients in the Middle East, as well as an ex-US study in pediatric subjects. We believe these additional clinical trials will supplement and enhance the data package that is currently being generated by our ongoing studies here in the US. As a leading company in this space, we are fully committed to generating a compelling body of clinical evidence to support global regulatory approval for QRX003 as a safe and effective treatment for Netherton syndrome.

此外，在本季度，我們在啟動更多Netherton 綜合徵臨床研究的計劃方面取得了實質性進展，其中包括在中東預先確定的約20 名Netherton 患者隊列中進行的一項研究，以及一項針對兒科受試者的前美國研究。我們相信這些額外的臨床試驗將補充和增強我們目前在美國正在進行的研究正在生成的數據包。作為該領域的領先公司，我們完全致力於產生令人信服的臨床證據，以支持全球監管機構批准 QRX003 作為一種安全有效的 Netherton 綜合徵治療方法。

During the quarter, we also continued to engage actively with Queensland University of Technology, or QUT, in Australia. Quoin has two ongoing research programs with QUT, one for scleroderma and the other for Netherton syndrome. The active ingredient in the latter program has a different mechanism of action to our own QRX003, and we believe this product potentially has complementary features to QRX003.

本季度，我們還繼續與澳大利亞昆士蘭科技大學 (QUT) 積極合作。 Quoin 與昆士蘭科技大學正在進行兩項研究項目，一項針對硬皮病，另一項針對內瑟頓綜合徵。後一個方案中的活性成分與我們自己的 QRX003 具有不同的作用機制，我們相信該產品可能與 QRX003 具有互補的功能。

As previously outlined, while both of these programs are still at an early stage of development, we continue to believe that they are important components of our product portfolio, and we look forward to their advancement into clinical testing. Both research programs are being conducted in Australia, where Quoin is able to take advantage of a 43.5% tax rebate from the Australian government, as well as a more rapid advancement into human clinical testing than as possible here in the US or in Europe.

如前所述，雖然這兩個項目仍處於開發的早期階段，但我們仍然相信它們是我們產品組合的重要組成部分，我們期待它們進入臨床測試。這兩個研究項目均在澳大利亞進行，Quoin 能夠享受澳大利亞政府 43.5% 的退稅，並且比美國或歐洲更快地進入人體臨床測試。

Also, during the quarter, we made tangible progress on our plans to initiate clinical testing of QRX003 in additional indications beyond Netherton syndrome. These indications include peeling skin syndrome, SAM syndrome, and palmoplantar keratoderma, none of which there are any approved treatments for. We hope to provide further updates on our progress in the near future, including timing of initiation of proof-of-concept clinical testing in patients.

此外，在本季度，我們在 Netherton 綜合徵以外的其他適應症中啟動 QRX003 臨床測試的計劃取得了切實進展。這些適應症包括皮膚脫皮綜合徵、SAM 綜合徵和掌蹠角化症，但目前還沒有任何批准的治療方法。我們希望在不久的將來提供有關我們進展的進一步更新，包括在患者中啟動概念驗證臨床測試的時間。

During our last call, I also updated everyone on our M&A strategy. As discussed, given our strong balance sheet and the potential access to additional capital, we are acutely focused on expanding our product portfolio via acquisition, licensing, or other means. We are primarily interested in late-stage assets in the rare and orphan disease space that are underpinned by strong clinical data and highly favorable commercial opportunities based on readily identifiable competitive strengths.

在上次電話會議中，我還向大家介紹了我們的併購戰略。正如所討論的，鑑於我們強大的資產負債表和獲得額外資本的潛力，我們非常注重通過收購、許可或其他方式擴大我們的產品組合。我們主要對罕見和孤兒疾病領域的後期資產感興趣，這些資產以強大的臨床數據和基於易於識別的競爭優勢的高度有利的商業機會為基礎。

While there can be no guarantees that a transaction will be consummated, I can tell you that a number of discussions continued to advance significantly throughout the quarter, and we are optimistic that Quoin will enter into at least one such transaction by the end of the year. We look forward to keeping you updated on our progress during this very exciting time for Quoin.

雖然不能保證交易一定會完成，但我可以告訴您，整個季度的一些討論繼續取得顯著進展，我們樂觀地認為 Quoin 將在年底前達成至少一項此類交易。在 Quoin 的這個激動人心的時刻，我們期待向您通報我們的最新進展。

Also on our last call, I noted that another company has filed an IND with the FDA and received a study-may-proceed letter to initiate the clinical development of their product as a potential treatment for Netherton syndrome. As of this morning, following a review of the clinicaltrials.gov website, it appears that this study has not yet been initiated and Quoin remains the only pharmaceutical company to be actively conducting clinical studies in Netherton syndrome under an open investigational new drug application or IND. We and our eight global commercial partners continue to be excited by the extent of the commercial opportunity that obtaining the first regulatory approval for a treatment for this disease represents.

同樣在我們最後一次通話中，我注意到另一家公司已向 FDA 提交了 IND 申請，並收到了一封可能繼續研究的信函，以啟動其產品的臨床開發，作為 Netherton 綜合徵的潛在治療方法。截至今天上午，經過對 ClinicalTrials.gov 網站的審查，這項研究似乎尚未啟動，Quoin 仍然是唯一一家在開放研究性新藥申請或 IND 下積極開展 Netherton 綜合徵臨床研究的製藥公司。我們和我們的八個全球商業合作夥伴繼續對獲得該疾病治療的首次監管批准所帶來的商業機會感到興奮。

Turning now to our ongoing clinical studies in Netherton syndrome patients. Today, we had the privilege of announcing the availability of clinical data from the first subject to complete testing in our open-label study. I'm very pleased to be able to tell you that this data is positive across all measured endpoints.

現在轉向我們正在進行的針對內瑟頓綜合徵患者的臨床研究。今天，我們有幸宣布我們的開放標籤研究中從第一個受試者到完成測試的臨床數據的可用性。我很高興能夠告訴您，該數據在所有測量的端點上都是積極的。

You may recall that in this open-label study, subjects are currently receiving off-label systemic treatment and will continue to do so in conjunction with QRX003 for the duration of the study. It is worth noting that all subjects in the study have been treated with off-label systemic therapy for at least one year, and in a number of cases, for multiple years. Notwithstanding this ongoing and long-term systemic therapy treatment, all patients recruited into the study demonstrated clear symptoms of Netherton syndrome, including compromised skin and pruritus or itch.

您可能還記得，在這項開放標籤研究中，受試者目前正在接受標籤外全身治療，並將在研究期間繼續與 QRX003 聯合治療。值得注意的是，該研究中的所有受試者都接受了標籤外全身治療至少一年，並且在許多情況下接受了多年。儘管進行了這種持續和長期的全身治療，但所有納入研究的患者都表現出明顯的內瑟頓綜合徵症狀，包括皮膚受損和瘙癢或發癢。

As a result of this long-term systemic therapy, subjects recruited into the study provided a natural baseline for us to assess if treatments with QRX003 over a duration of 12 weeks would lead to any therapeutic improvement across a number of assessed clinical endpoints. And so it was for the first subject who completed testing in the study. Despite the long-term systemic therapy, the subject exhibited classic symptoms of Netherton syndrome on entry into the study.

由於這種長期的全身治療，招募到該研究中的受試者為我們提供了自然基線，以評估 QRX003 在 12 週內的治療是否會導致許多評估的臨床終點的治療改善。第一個完成研究測試的受試者也是如此。儘管接受了長期的全身治療，受試者在進入研究時仍表現出內瑟頓綜合徵的典型症狀。

However, I'm very pleased to say, on completion of the study for this subject, the QRX003 treatment area was deemed to be fully clear, both by the clinical investigator as well as by a well-recognized visual scoring system. Furthermore, the subject also expressed a very favorable impression of QRX003 across a number of important metrics. Importantly also, upon completion of the study, this subject's pruritus or itch at the QRX003 treatment area was deemed to be negligible.

然而，我很高興地說，在完成該受試者的研究後，臨床研究人員以及公認的視覺評分系統都認為 QRX003 治療區域是完全清晰的。此外，受試者還對 QRX003 的多項重要指標表示了非常好的印象。同樣重要的是，研究完成後，該受試者 QRX003 治療區域的瘙癢或瘙癢被認為可以忽略不計。

Bear in mind that one of the primary reasons for people with Netherton syndrome to go on systemic therapies is for symptomatic relief from their pruritus. For this particular subject, despite having been on systemic therapy for well over a year, it was only after 12 weeks of treatment with QRX003 that their pruritus had decreased to a negligible level.

請記住，內瑟頓綜合徵患者接受全身治療的主要原因之一是緩解瘙癢症狀。對於這個特定的受試者，儘管已經接受了一年多的全身治療，但直到使用 QRX003 治療 12 週後，他們的瘙癢症才降至可以忽略不計的水平。

Although this data represents an important milestone for Quoin, as it is the first clinical evidence of the potential efficacy of QRX003 in Netherton syndrome, I do want to strongly caution that it is from a single patient only, and care should be taken not to read too much into this data. As other patients in the study reach the same point, we plan to provide additional updates in due course.

儘管這一數據對 Quoin 來說是一個重要的里程碑，因為它是 QRX003 對 Netherton 綜合徵潛在療效的第一個臨床證據，但我確實想強烈警告，它僅來自單個患者，並且應注意不要閱讀太多的數據。隨著研究中的其他患者達到同樣的水平，我們計劃在適當的時候提供更多更新。

As mentioned earlier, our ongoing double-blinded study is now on track to have a majority of subjects recruited this month. We are frequently asked if the open-label study is cannibalizing subjects from the double-blinded study, and I can tell you this is not the case at all. Both studies are recruiting independently of each other, and feedback from the Netherton community is that the availability of two such distinct clinical trial options allows patients the flexibility to enroll in a study that is best suited to their own ongoing treatment regimen.

如前所述，我們正在進行的雙盲研究目前有望在本月招募大部分受試者。我們經常被問到開放標籤研究是否正在蠶食雙盲研究中的受試者，我可以告訴你事實並非如此。這兩項研究都是相互獨立的招募，來自 Netherton 社區的反饋是，兩種不同的臨床試驗選項的可用性使患者能夠靈活地參加最適合自己正在進行的治療方案的研究。

I also want to highlight that in both studies to date and across all subjects tested, QRX003 is demonstrating an exemplary safety profile. Given the highly compromised skin that Netherton patients have, this is very encouraging news and further bolsters our confidence in the potential for QRX003 to become the first product to safely and effectively treat this disease.

我還想強調的是，在迄今為止的兩項研究和所有測試對像中，QRX003 都展示了堪稱典範的安全性。鑑於 Netherton 患者的皮膚高度受損，這是一個非常令人鼓舞的消息，並進一步增強了我們對 QRX003 成為第一個安全有效治療這種疾病的產品潛力的信心。

With that update on our operational progress, let me turn it over to Gordon now to discuss our second-quarter financial results.

關於我們的運營進展的最新情況，現在讓我將其交給戈登討論我們第二季度的財務業績。

Thank you, Michael. As of June 30, our cash and marketable securities was approximately $15.4 million, compared to $17 million as of March 31, which we continue to expect will be sufficient to fund our operations into late 2024.

謝謝你，邁克爾。截至 6 月 30 日，我們的現金和有價證券約為 1,540 萬美元，而截至 3 月 31 日為 1,700 萬美元，我們仍然預計這將足以為我們的運營提供資金到 2024 年底。

Our net loss for the second quarter was $2.1 million, compared to $2.7 million for the second quarter of 2022. The decrease was primarily due to exceptionally high legal and professional fees in the second quarter of 2022.

我們第二季度的淨虧損為 210 萬美元，而 2022 年第二季度為 270 萬美元。這一下降主要是由於 2022 年第二季度的法律和專業費用異常高。

I'll now turn the call back to Michael to make some closing remarks and begin our Q&A. Michael?

現在我將把電話轉回給邁克爾，讓他做一些結束語並開始我們的問答。邁克爾？

Thanks, Gordon. Today marks an important milestone for Quoin and we hope for Netherton syndrome patients everywhere. We are extremely excited to announce the results of the very first clinical data for QRX003 in Netherton patients.

謝謝，戈登。今天對 Quoin 來說是一個重要的里程碑，我們希望世界各地的內瑟頓綜合徵患者都能康復。我們非常高興地宣布 QRX003 在 Netherton 患者中的第一個臨床數據結果。

As outlined, we strongly caution, and I do want to emphasize this point, the data is just from a single subject only and may not be representative of findings from additional subjects. However, that being said, the positive nature of the data across all measured clinical endpoints is certainly encouraging. With both of our studies continuing to recruit subjects, we look forward to releasing additional data in due course.

正如所概述的，我們強烈警告，並且我確實想強調這一點，這些數據僅來自單個受試者，可能不能代表其他受試者的發現。然而，話雖這麼說，所有測量的臨床終點數據的積極性質無疑令人鼓舞。隨著我們的兩項研究繼續招募受試者，我們期待在適當的時候發布更多數據。

We remain diligently focused on pursuing M&A activities and are targeting executing at least one such transaction by year-end.

我們仍然致力於開展併購活動，併計劃在年底前執行至少一項此類交易。

With that, operator, we are now ready for questions.

接線員，現在我們準備好提問了。

(Operator Instructions) Naz Rahman, Maxim Group.

（操作員說明）Naz Rahman，Maxim 集團。

Hi, everyone. Congratulations on the data and the progress. I'm going to talk a little more about the data you saw from the single patient. I just want to start on, can you talk a little more about the onset, the cadence, and I guess the timing of the benefits? Did you see most of the benefits early in the trial, or did you see more of the benefits towards the end of the trial?

大家好。祝賀數據和進展。我將更多地討論您從單個患者身上看到的數據。我只是想開始，你能多談談起效、節奏以及我猜的好處的時間嗎？您是在試驗初期看到了大部分好處，還是在試驗結束時看到了更多好處？

And is the timing of the different benefits or, I guess, improvements on the different endpoints consistent for the different endpoints, or did different endpoints sort of reach, I guess, positive stats or positive results at different time points?

不同的好處的時間，或者我猜，不同端點的改進對於不同的端點來說是一致的，還是不同的端點在不同的時間點達到了積極的統計數據或積極的結果？

Morning, Naz. Thanks for the call, and thanks, as always, for participating. So really good questions.

早上好，納茲。感謝您的來電，並一如既往地感謝您的參與。非常好的問題。

The benefit really started to become evident for this particular subject in the second half of the study. So as you know, it's a 12-week dosing period, so it was really from six weeks on. Now, we're not assessing the patient every week, so it's hard to pinpoint exactly when, but certainly, it was in the second half of the study. And the timing of onset of benefit was consistent across all of the endpoints. So once the benefit started to kick in, it became evident across each of the four endpoints that were being measured.

在研究的後半段，這個特定主題的好處才真正開始變得明顯。如您所知，這是一個 12 週的給藥期，所以實際上是從六週開始。現在，我們不會每週對患者進行評估，因此很難確定具體時間，但可以肯定的是，是在研究的後半段。所有終點的獲益時間都是一致的。因此，一旦效益開始顯現，它就會在所測量的四個端點中變得明顯。

Got you. That was helpful. I know it's only been so long since you evaluated that first patient. But since the patient has been off therapy, did you guys conduct a follow up? And has the patient seen any recurrence of symptoms, or have you found durability?

明白你了。這很有幫助。我知道距離您評估第一個病人才過去這麼長時間。但是既然病人已經停止治療了，你們有進行隨訪嗎？患者是否發現症狀復發，或者您是否發現症狀持續存在？

So that's information I don't have, Naz. The way the study was set up is that the patient was enrolled in the study, treated for 12 weeks, and then they're gone. So there really isn't follow up. Now, we are looking to see if we can continue to treat patients further in an extended open-label part of the study. But I don't have any information as to what the current situation with that patient is.

所以這是我沒有的信息，納茲。研究的設立方式是，患者參加研究，接受 12 週的治療，然後就離開了。所以確實沒有後續。現在，我們正在研究是否可以在研究的擴展開放標籤部分中繼續進一步治療患者。但我不知道該患者目前的情況如何。

I will tell you, though, that the product QRX003 is a competitive serine protease inhibitor. So once you discontinue treatment with it, then it targets the colloquines in the skin that are responsible for a lot of the issues that patients suffer from. Once you discontinue treatment, those colloquines go back to being out of control. So I would strongly suspect that the treatment areas of the patient have now reversed back to the previous Netherton syndrome symptoms that they had on entry into the study.

不過，我會告訴您，產品 QRX003 是一種有競爭力的絲氨酸蛋白酶抑製劑。因此，一旦您停止使用它進行治療，它就會針對皮膚中的考洛喹，而這些考考喹是導致患者遭受許多問題的原因。一旦停止治療，這些考洛奎就會重新失去控制。因此，我強烈懷疑患者的治療部位現在已經恢復到他們進入研究時所出現的內瑟頓綜合徵症狀。

Got it. And my last question is somewhat of a two-parter. Once again, acknowledging that this is just data from a single patient, has these findings somewhat impacted your thinking on how you might refine or adjust later studies? And also, since Netherton syndrome is really like a full-body disease, are you considering potentially having larger application or more application areas for later studies?

知道了。我的最後一個問題有點像兩個問題。再次承認這只是來自單個患者的數據，這些發現是否在一定程度上影響了您對如何完善或調整後續研究的想法？而且，由於內瑟頓綜合徵確實像一種全身疾病，您是否考慮在以後的研究中可能有更大的應用或更多的應用領域？

Yeah. So these are really good questions. We started this -- we went into complete uncharted territory. Nobody had ever been there before, and neither us nor the FDA had any precedence. So our thinking is starting to evolve now as data starts to be generated.

是的。所以這些都是很好的問題。我們開始了這個——我們進入了完全未知的領域。以前沒有人去過那裡，我們和 FDA 都沒有先例。因此，隨著數據開始生成，我們的思維現在開始演變。

First of all, and importantly, we're not seeing any safety signals, so that's really good news. So that allows us to think, holistically, should we increase the dose? Should we maybe look to dose twice a day? So these are discussions that we're having because now, we feel like these options come into play.

首先，重要的是，我們沒有看到任何安全信號，所以這確實是個好消息。因此，這讓我們能夠從整體上思考，我們是否應該增加劑量？我們是否應該每天服用兩次？所以我們正在進行這些討論，因為現在我們覺得這些選擇開始發揮作用。

And with regard to full-body dosing, that is something that we are talking about. I mentioned a potential study in the Middle East on pre-identified Netherton patients. That's something that we're considering for that particular study. I don't feel like we will deviate too far from what we have agreed with the FDA for US approval. But certainly, for these other studies, there's a lot more scope to either increase the dose, increase the frequency, and increase the surface area that's been tested.

關於全身劑量，這就是我們正在討論的事情。我提到了中東可能進行的一項針對預先確定的內瑟頓患者的研究。這是我們針對該特定研究正在考慮的事情。我不認為我們會偏離與 FDA 就美國批准達成的協議太遠。但當然，對於這些其他研究來說，增加劑量、增加頻率和增加已測試的表面積還有更大的餘地。

Got it. Once again, congratulations on the data, and looking forward to your future readouts.

知道了。再次祝賀您獲得數據，並期待您未來的讀數。

Thanks, Naz.

謝謝，納茲。

(Operator Instructions) Jim Malloy, Alliance Global Partners.

（操作員說明）Jim Malloy，Alliance Global Partners。

Hello, this is Laura calling in for Jim Malloy. Thank you for taking our questions. So with the enrollment for both the QRX003 trials moving along, what's the potential timing here for topline data and subsequent Phase 3 program as well?

您好，我是勞拉 (Laura) 給吉姆·馬洛伊 (Jim Malloy) 打電話。感謝您接受我們的提問。那麼，隨著 QRX003 試驗的註冊工作不斷進行，一線數據和後續 3 期計劃的潛在時機是什麼？

So we certainly will have topline data from the open-label study by the end of the year and believe for the double-blinded study early in next year. So we were continuing to target regulatory approval in the early part of 2025. So we are in a position to move pretty quickly here. And as you know, the number of patients that we need for approval is quite limited, so I think those targets remain.

因此，我們肯定會在今年年底前獲得開放標籤研究的主要數據，並相信明年初就會有雙盲研究。因此，我們繼續以 2025 年初獲得監管批准為目標。因此，我們能夠在這方面迅速採取行動。如您所知，我們需要批准的患者數量非常有限，所以我認為這些目標仍然存在。

Got it. And then also, you've mentioned the 20-patient study to be conducted in the Middle East. So just what are some of the other updates you have on the potential expansion of QRX003 outside the US, and maybe some of the timelines here as well?

知道了。此外，您還提到了將在中東進行的 20 名患者研究。那麼，關於 QRX003 在美國以外地區的潛在擴張，你們有哪些其他更新，也許還有一些時間表？

Yeah. So as you know, we have established eight commercial partnerships outside of the US that now span 60 countries. So our focus here is not just US and Europe. We are looking at this as a global opportunity.

是的。如您所知，我們在美國以外建立了八個商業合作夥伴關係，目前遍布 60 個國家/地區。因此，我們的重點不僅僅是美國和歐洲。我們將此視為一個全球機遇。

So the data that we're starting to generate now from these ongoing studies could be used by some of our partners to obtain approval earlier in their respective jurisdictions than, say, in the US and Europe, and also allow for entry into compassionate use or early access programs. So the generation of data now starts to open up a lot of opportunities for us, and as we continue to assess how do we build the strongest possible database for this product, we're looking at these additional studies.

因此，我們現在開始從這些正在進行的研究中生成的數據可以被我們的一些合作夥伴使用，以便比美國和歐洲更早地在各自的司法管轄區獲得批准，並且還允許進入同情使用或搶先體驗計劃。因此，數據的生成現在開始為我們帶來很多機會，當我們繼續評估如何為該產品構建最強大的數據庫時，我們正在研究這些額外的研究。

So we're taking a very broad-based look at this. We're in very close communication with our commercial partners, what are their needs to obtain approval in their countries. So a lot of behind-the-scenes discussions happening, Laura, and stay tuned. We'll have further updates.

因此，我們正在對此進行非常廣泛的研究。我們與我們的商業合作夥伴保持著非常密切的溝通，了解他們需要什麼才能在各自國家獲得批准。因此，有很多幕後討論正在發生，勞拉，請繼續關注。我們將有進一步的更新。

Got it. Thank you for taking the questions, and congratulations on the progress this quarter.

知道了。感謝您提出問題，並祝賀本季度取得的進展。

This concludes our question-and-answer session. I would like to turn the conference back over to Michael Myers for any closing remarks.

我們的問答環節到此結束。我想將會議轉回邁克爾·邁爾斯進行閉幕致辭。

Thank you. Just to say, I appreciate everybody turning up this morning. As always, if you have any further questions or need any additional information, please feel free to reach out to us. We remain readily accessible. So have a great day, and thank you very much.

謝謝。只是想說，我很感謝今天早上大家的到來。與往常一樣，如果您有任何其他問題或需要任何其他信息，請隨時與我們聯繫。我們仍然很方便。祝您有美好的一天，非常感謝。

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。