Iterum Therapeutics PLC (ITRM) 2021 Q3 法說會逐字稿

Hello, and welcome to the Iterum Therapeutics Q3 Financial Results Conference Call. My name is Alex, and I will be your operator for today. (Operator Instructions) I will now hand over to your host, Louise Barrett, Senior Vice President, Legal Affairs. Louise, over to you.

您好，歡迎參加 Iterum Therapeutics 第三季財務業績電話會議。我叫亞歷克斯，今天我將擔任您的接線生。 （操作員指示）我現在將會議交給主持人，法律事務部資深副總裁 Louise Barrett。路易絲，交給你了。

Thank you, Alex. Good morning, and welcome to Iterum Therapeutics' Third Quarter 2021 Financial Results and Business Update Conference Call. A press release with our third quarter results was issued earlier this morning and can be found on our website.

謝謝你，亞歷克斯。早安，歡迎參加 Iterum Therapeutics 2021 年第三季財務業績和業務更新電話會議。今天早上早些時候發布了我們第三季業績的新聞稿，可以在我們的網站上找到。

We are joined this morning by Corey Fishman, CEO; and Judy Matthews, CFO. Corey will provide some opening remarks. Judy will provide some details on our financial results, and then we will open the line for Q&A.

今天早上，執行長科里·菲什曼 (Corey Fishman) 也加入了我們的行列。和財務長朱迪·馬修斯。科里將發表一些開場白。朱迪將提供有關我們財務業績的一些詳細信息，然後我們將開通問答熱線。

Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning our plans, strategies and prospects for our business, including with respect to planned interactions and communications with the FDA and our ability to reach agreement with the FDA on the design of any potential future clinical trials. Our expectations with regard to our ability to resolve the matters set forth in the complete response that received in July 2021 and obtained approval for oral sulopenem, the conduct of potential future clinical and nonclinical development of sulopenem and the sufficiency of our cash resources to execute on our strategy.

在我們開始之前，我想提醒您，本次電話會議將包含有關我們的計劃、策略和業務前景的前瞻性陳述，包括與 FDA 計劃的互動和溝通以及我們與 FDA 達成協議的能力FDA 負責設計任何潛在的未來臨床試驗。我們對解決 2021 年 7 月收到的完整答覆中提出的問題的期望，並獲得口服磺培南的批准，進行磺培南未來潛在的臨床和非臨床開發，以及我們有足夠的現金資源來執行我們的策略。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including uncertainties inherent in the initiation and conduct of clinical and nonclinical development; availability and timing of data from such clinical trials and nonclinical development; the timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for oral sulopenem; changes in public policy or legislation; the actions of third-party clinical research organizations, suppliers and manufacturers; the accuracy of our expectations regarding how far into the future the company's cash on hand will fund our ongoing operations, including completing potential additional clinical and nonclinical development of oral sulopenem; the impact of COVID-19 and related response measures thereto; our ability to maintain our listing on the NASDAQ Capital Market; and other risk factors set out in our filings with the SEC, including our most recently filed quarterly report on Form 10-Q.

由於各種重要因素，包括臨床和非臨床開發的啟動和進行所固有的不確定性，實際結果可能與這些前瞻性陳述所顯示的結果有重大差異；此類臨床試驗和非臨床開發數據的可用性和時間表；監管備案和批准的時間或可能性，包括可能重新提交我們的口服硫培南 NDA；公共政策或立法的變化；第三方臨床研究組織、供應商和製造商的行為；我們對於未來多久公司手頭現金將為我們持續營運提供資金的預期的準確性，包括完成口服磺培南潛在的額外臨床和非臨床開發； COVID-19 的影響及其相關應對措施；我們維持在納斯達克資本市場上市的能力；以及我們向 SEC 提交的文件中列出的其他風險因素，包括我們最近提交的 10-Q 表格季度報告。

In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements.

此外，任何前瞻性陳述僅代表我們截至本次電話會議之日的觀點，不應被視為代表我們在任何後續日期的觀點。我們明確聲明不承擔更新此類聲明的義務。

We will also be referencing non-GAAP financial measures during the call. We've provided reconciliations of GAAP reported to non-GAAP adjusted information in the press release issued this morning.

我們也會在電話會議期間參考非公認會計準則財務指標。我們在今天早上發布的新聞稿中提供了 GAAP 報告與非 GAAP 調整資訊的調整表。

With that said, I'll turn it over to you, Corey, for your opening remarks.

話雖如此，科里，我會把它交給你做開場白。

Thanks, Louise. Welcome, and thank you for joining us today. I'll be providing a brief update this morning. As we previously mentioned, we had requested a Type A meeting with the FDA to discuss our complete response letter that we received in late July. We recently had that meeting and the FDA informed us that, in their opinion, the totality of our NDA package was not sufficient to warrant approval for oral sulopenem at that time, even though they acknowledge that sulopenem showed statistical significance in the overall response rate by treatment arm against ciprofloxacin in the ciprofloxacin resistant population in the treatment of uncomplicated urinary tract infections.

謝謝，路易絲。歡迎，感謝您今天加入我們。今天早上我將提供一個簡短的更新。正如我們之前提到的，我們已要求與 FDA 召開 A 類會議，討論我們 7 月下旬收到的完整回覆函。我們最近舉行了那次會議，FDA 通知我們，他們認為，我們的 NDA 方案的全部內容不足以保證當時口服磺培南的批准，儘管他們承認磺培南在總體緩解率方面顯示出統計顯著性在環丙沙星抗藥性族群中針對環丙沙星治療單純性泌尿道感染。

We then discussed what additional clinical work would be required in order to have a package that they deemed potentially adequate for approval, assuming the trial results were successful. The FDA feedback received was that one additional Phase III clinical trial should be sufficient, subject, of course, to reaching agreement with the FDA on the design of that trial. We have since requested a Type B meeting with the FDA to discuss the details of that additional trial, including the protocol, endpoints and other relevant factors.

然後，我們討論了假設試驗結果成功，需要進行哪些額外的臨床工作才能獲得他們認為可能足以獲得批准的方案。 FDA 收到的回饋是，一項額外的 III 期臨床試驗應該足夠了，當然，前提是與 FDA 就該試驗的設計達成一致。此後，我們要求與 FDA 召開 B 類會議，討論該額外試驗的細節，包括方案、終點和其他相關因素。

Our hope is that after this meeting, which we expect to occur around year-end, we will have clarity on all major aspects of the additional trial required to support potential resubmission of our NDA and be able to work expeditiously to get that study enrolling patients in the first half of 2022.

我們希望，在這次會議（預計在年底左右舉行）之後，我們將明確支持重新提交新藥申請所需的額外試驗的所有主要方面，並能夠迅速開展工作，讓該研究招募患者2022年上半年。

It's important to note that given the urgent unmet medical need for new oral treatments for uncomplicated urinary tract infections, we remain confident in the value of oral sulopenem to treat multidrug-resistant infections and strongly believe sulopenem could be an important and valuable product for physicians and patients.

值得注意的是，鑑於對新的口服治療單純性泌尿道感染的迫切未滿足的醫療需求，我們對口服磺培南治療多重抗藥性感染的價值仍然充滿信心，並堅信磺培南對於醫生和患者來說可能是重要且有價值的產品。患者。

Lastly, I'll spend just a moment on our cash position and outlook. We ended Q3 with a strong cash balance of approximately $86 million on the balance sheet. Based on our latest forecasts, we anticipate this cash balance will fund the company into 2024 and allow us to complete the proposed additional clinical development of sulopenem to support, if successful, the resubmission of our NDA to the FDA for the treatment of uncomplicated urinary tract infections.

最後，我將花一點時間談談我們的現金狀況和前景。第三季末，我們的資產負債表上擁有約 8,600 萬美元的強勁現金餘額。根據我們的最新預測，我們預計這筆現金餘額將為公司提供資金到2024 年，並使我們能夠完成擬議的硫培南額外臨床開發，如果成功的話，將支持我們向FDA 重新提交用於治療簡單尿路的NDA感染。

Now I'll turn the call over to Judy for details on our financial results.

現在我將把電話轉給朱迪​​，以了解我們財務表現的詳細資訊。

Thanks, Corey. Total operating expenses were $4.9 million in the third quarter of 2021 compared to $6.3 million in the third quarter of 2020.

謝謝，科里。 2021 年第三季的總營運費用為 490 萬美元，而 2020 年第三季為 630 萬美元。

Operating expenses include research and development expenses and general and administrative expenses. R&D costs were $1.8 million for the third quarter of 2021 compared to $3.9 million for the same period in 2020. The R&D category includes expenses for our clinical and development programs, our CMC costs and our regulatory expenses. The primary driver of the $2.1 million decrease in R&D costs was the completion of our Phase III program in 2020.

營業費用包括研發費用以及一般及管理費用。 2021 年第三季的研發成本為 180 萬美元，而 2020 年同期為 390 萬美元。研發類別包括我們的臨床和開發項目費用、CMC 成本和監管費用。研發成本減少 210 萬美元的主要原因是我們的 III 期計畫於 2020 年完成。

G&A costs were $3 million for the third quarter of 2021, which is $600,000 higher than G&A costs of $2.4 million in the third quarter of 2020 due primarily to higher share-based compensation for employees and directors.

2021 年第三季的一般管理費用為 300 萬美元，比 2020 年第三季的一般管理費用 240 萬美元高出 60 萬美元，這主要是由於員工和董事的股份薪酬增加。

Moving on to nonoperating items. Interest expense was $800,000 for the third quarter of 2021 compared to $4.2 million in the third quarter of 2020. The primary reason for the $3.4 million decrease in interest expense was noncash interest expense associated with the lower exchangeable note balance of $12.6 million as of September 30, 2021 versus $51.8 million as of September 30, 2020.

繼續討論非營運項目。 2021 年第三季的利息支出為80 萬美元，而2020 年第三季的利息支出為420 萬美元。利息支出減少340 萬美元的主要原因是與截至9 月30 日可交換票據餘額減少1,260 萬美元相關的非現金利息支出，2021 年為 5,180 萬美元，截至 2020 年 9 月 30 日為 5,180 萬美元。

On a strictly cash basis, we paid interest related to our term loan with SVB of approximately $90,000 in the third quarter of 2021 versus approximately $220,000 in the third quarter of 2020. The reduction in cash interest is largely due to a lower principal balance on our term loan as monthly amortization began in the fourth quarter of 2019 and will continue until our final payment in March 2022. As of September 30, 2021, there was a remaining balance of $3.2 million on our term loan with SVB.

在嚴格的現金基礎上，我們在2021 年第三季向SVB 支付了約90,000 美元的定期貸款利息，而2020 年第三季約為220,000 美元。現金利息減少主要是由於我們的本金餘額較低。定期貸款按月攤銷從 2019 年第四季開始，並將持續到 2022 年 3 月我們最終付款為止。截至 2021 年 9 月 30 日，我們向 SVB 提供的定期貸款餘額為 320 萬美元。

Our net income on a U.S. GAAP basis of $3.7 million was driven by a $9.8 million noncash adjustment to report a decrease in the value of the derivative components associated with our exchangeable notes as a result of a decrease in the price of our ordinary shares and market capitalization during the period. There was no impact of this adjustment on cash or cash runway, which I will turn to in a moment.

根據美國公認會計原則，我們的淨利潤為370 萬美元，這是由於我們的普通股和市場價格下跌導致與我們的可交換票據相關的衍生品部分的價值下降，因此進行了980 萬美元的非現金調整期間資本化。這次調整對現金或現金跑道沒有影響，我稍後會談到這一點。

On a non-GAAP basis, which excludes certain noncash adjustments, including adjustments to record derivatives at their fair value, our net loss of $5.2 million in the third quarter of 2021 was $1.8 million less than our net -- non-GAAP net loss of $7 million in the third quarter of 2020 as a result of the lower operating expenses previously discussed.

根據非公認會計原則（不包括某些非現金調整，包括以公允價值記錄衍生性商品的調整）計算，我們2021 年第三季的淨虧損為520 萬美元，比2021 年第三季的非公認會計原則淨虧損少了180 萬美元。由於先前討論的營運費用降低，2020 年第三季營收為 700 萬美元。

At the end of September, we had cash and short-term investments of $85.7 million. Based on our current operating plan and subject to final determination of the design plan conduct of potential additional clinical and nonclinical development for sulopenem, we have cash into 2024. As such, we anticipate that our existing cash will be sufficient to allow us to complete the proposed additional development of oral sulopenem to support, if successful, a resubmission of the NDA to the FDA for the treatment of UTI.

截至 9 月底，我們的現金和短期投資為 8,570 萬美元。根據我們目前的營運計劃，並根據對硫培南潛在額外臨床和非臨床開發的設計計劃進行最終確定，我們在 2024 年之前擁有現金。因此，我們預計現有現金將足以讓我們完成提議進一步開發口服硫培南，以支持如果成功的話，向FDA 重新提交用於治療UTI 的NDA。

As of September 30, 2021, we had approximately 183 million ordinary shares outstanding. Also as of the end of September, we had 7.2 million warrants outstanding at an average price of $1.61 per share and $12.6 million of exchangeable notes, which can be exchanged for approximately 18 million shares, which includes accrued interest at the option of the note holder.

截至2021年9月30日，我們擁有約1.83億股已發行普通股。截至9 月底，我們還有720 萬張已發行認股權證，平均價格為每股1.61 美元，還有1,260 萬美元的可交換票據，可兌換約1,800 萬股股票，其中包括票據持有人選擇的應計利息。

Now I will turn it back over to Corey for some comments.

現在我將把它轉回科里徵求一些意見。

Thanks, Judy. We'd like to take a moment and just open the lines up for questions now.

謝謝，朱迪。我們想花一點時間，現在就開始提問。

(Operator Instructions) Our first question for today comes from Gregory Renza from RBC Capital Markets.

（操作員說明）我們今天的第一個問題來自 RBC 資本市場的 Gregory Renza。

I look forward to all the upcoming progress. Corey, as you head into the Type B meeting, I'm just wondering if you could provide us with perhaps what your base case is on a trial design or any additional color at this point that you could touch on to just help us understand and maybe even baselining it to perhaps share, one, how you're thinking about that in size and scope. And then just second question is just around certainly a great deal of data you've generated already. I'm just curious if you have plans or how you're thinking about kind of reengaging the clinical and medical community and maybe sharing that data in parallel as you initiate a second pivotal trial.

我期待著即將到來的所有進展。 Corey，當您進入 B 類會議時，我只是想知道您是否可以向我們提供您的試驗設計的基本情況或此時您可以提及的任何其他顏色，以幫助我們理解和甚至可能為其設定基線，以便分享，一，您如何考慮其規模和範圍。第二個問題肯定是圍繞著您已經產生的大量數據。我只是好奇您是否有計劃或如何考慮重新參與臨床和醫學界，並可能在啟動第二個關鍵試驗時並行共享這些數據。

Sure. Well, thanks, Greg, for the questions. I appreciate it. With regard to the first question, we really don't have a lot of details that are in a state that we're able to share yet regarding the study design simply because we have not yet solidified with the agency what that study design will be. And I'd rather not share sort of our thinking now and then have to come back to you all and say, well, FDA said this, and they said that, and we have to change it.

當然。好吧，謝謝格雷格提出的問題。我很感激。關於第一個問題，我們確實沒有很多關於研究設計的細節可以分享，因為我們還沒有與該機構確認研究設計是什麼。我不想現在分享我們的想法，然後必須回到大家身邊說，好吧，FDA 這麼說，他們這麼說，我們必須改變它。

Suffice to say that we will be doing a study per the guidance that FDA has issued a couple of years back for those trials and uncomplicated urinary tract infections. And our goal of the Type B meeting is to work with them on the specifics of that. We also aren't just sitting on our hands, as you'd imagine, we have begun conversations with a number of external vendors, including CROs to talk about the generalities, talk about the sites, talk about -- we don't have specifics yet to be able to say, here's exactly what we want to do. But we've begun all those conversations, and our CMC team has been working very hard on making sure we have plenty of clinical supply, which we do and figuring out the time lines for all of that to be able to get us to start this study in the first half of next year. I think that's probably as much as I can tell you that is valid and important for now.

可以說，我們將根據 FDA 幾年前針對這些試驗和簡單尿路感染發布的指南進行一項研究。我們召開 B 類會議的目標是與他們就具體細節進行合作。我們也不會像您想像的那樣袖手旁觀，我們已經開始與包括 CRO 在內的許多外部供應商進行對話，討論一般性問題，討論網站，討論——我們沒有具體細節還不能說，這正是我們想要做的。但我們已經開始了所有這些對話，我們的 CMC 團隊一直在努力確保我們擁有充足的臨床供應，我們這樣做了，並確定了所有這些的時間表，以便我們能夠開始這項工作明年上半年學習。我想這可能是我目前能告訴你的有效且重要的訊息。

With regard to your second question, which was regarding the data. I agree with you, and we do actually have a plan to reengage in the medical community, talking about the data that we've generated because, as you know, it is very strong, and we have a great deal of data in uncomplicated UTI. And we also have data in complicated UTI as well that I think is interesting and important and certainly was supportive. And we want to make sure we get that out to the physicians, to the KOLs. And so we'll be working on presentations for upcoming meetings and conferences as well as manuscripts to try to at least help people understand the data that was generated, why we feel so good about the fact that we believe very strongly that this drug works well and just figuring out how to get that into the hands of the physicians and treating -- treating physicians and KOLs at the appropriate time is certainly on our radar for what we will be doing here over the next 6 to 12 months.

關於你的第二個問題，是關於數據的。我同意你的觀點，我們確實有一個重新參與醫學界的計劃，談論我們產生的數據，因為正如你所知，它非常強大，而且我們在簡單的泌尿道感染方面擁有大量數據。我們還有複雜泌尿道感染的數據，我認為這些數據很有趣、很重要，而且絕對是支持性的。我們希望確保將這一點傳達給醫生和 KOL。因此，我們將致力於為即將舉行的會議和會議準備演示文稿以及手稿，以嘗試至少幫助人們理解生成​​的數據，為什麼我們對我們非常堅信這種藥物效果良好這一事實感到如此滿意弄清楚如何將其交到醫生手中並在適當的時間治療醫生和KOL，這肯定是我們未來6 到12 個月在這裡要做的事情的考慮範圍。

Our final question for today comes from Ed Arce from H.C. Wainwright.

我們今天的最後一個問題來自 H.C. 的 Ed Arce。溫賴特。

This is Thomas Yip asking a couple of questions for Ed. Happy to see that sulopenem is back on track. Perhaps first, we would like to narrow down the meeting time line. Can you tell us when was the request formally accepted? And when do you expect the meeting to take place?

我是 Thomas Yip，向 Ed 問了幾個問題。很高興看到硫培南重回正軌。也許首先，我們想縮小會議時間範圍。您能否告訴我們該請求何時被正式接受？您預計會議何時舉行？

Yes. We put the request in, oh, I want to say probably 1 to 2 weeks ago, and we're expecting given that time line that the meeting should be granted around the end of the year. We'll provide more data as we get a solid data on that and have that conversation. But it should be in that year-end time frame. And that should allow us, Thomas, to be able to continue our planning as we've started to get this study up and running. And importantly, as we've talked about, I think, having the capital to do that is incredibly important for the company. So we are in a position that's pretty favorable from that standpoint.

是的。我們提出請求，哦，我想說大概是 1 到 2 週前，考慮到這個時間線，我們預計會議應該在年底左右獲得批准。當我們獲得可靠的數據並進行對話時，我們將提供更多數據。但應該是在年底的時間範圍內。托馬斯，這應該使我們能夠在我們開始啟動和運行這項研究時繼續我們的計劃。重要的是，正如我們所討論的，我認為擁有做到這一點的資本對公司來說非常重要。因此，從這個角度來看，我們處於非常有利的位置。

Yes. Understood. And as you alluded to earlier details for the new Phase III, you prefer not to discuss well ahead of the Type B meeting. Have you given any thoughts on specific geographical location that you will like to focus on to open sites and considering the ongoing impact of COVID-19?

是的。明白了。正如您所提到的新第三階段的早期細節，您不希望在 B 類會議之前進行討論。您是否對您希望重點開放網站的特定地理位置以及考慮到 COVID-19 的持續影響有何想法？

Yes, it's a really good question. And it's actually one of the things that our clinical folks as well as the rest of our team have been talking to the CROs. As I mentioned, we've started the conversation to better understand what's happening in various geographies. And that is -- from our perspective, that's not only in the U.S. geographies, but also in other countries.

是的，這是一個非常好的問題。這實際上是我們的臨床人員以及我們團隊的其他成員一直在與 CRO 討論的事情之一。正如我所提到的，我們開始對話是為了更好地了解不同地區正在發生的事情。從我們的角度來看，這不僅發生在美國地區，也發生在其他國家。

Historically, what we had done was predominantly in the U.S. for the uncomplicated UTI study. And we will continue to look at that as an option, but we will also look at other countries where there's an opportunity to get the highest quality work done in the most efficient time manner, which is, of course, what everybody does when they're looking at a study. But as you said, in the COVID world, that can be a little bit different. And so we're going to be sure that we are working with the CROs to understand what the flexibility is in various geographies here as well as other countries to be sure that we've got the best sites from a quality standpoint, but also from a time line standpoint. So it is an important consideration that we are taking into account as we look at who we choose in terms of a CRO and also the time lines for that study.

從歷史上看，我們所做的主要是在美國進行簡單的泌尿道感染研究。我們將繼續將此視為一種選擇，但我們也會關注其他國家，這些國家有機會以最有效的時間方式完成最高品質的工作，當然，這也是每個人在工作時都會做的事情。正在研究一項研究。但正如你所說，在新冠疫情的世界裡，情況可能會有所不同。因此，我們將確保與 CRO 合作，了解這裡以及其他國家不同地區的靈活性，以確保我們從品質的角度以及從時間軸的觀點。因此，當我們選擇 CRO 以及研究的時間表時，這是我們要考慮的一個重要考慮因素。

Okay. That makes sense. Perhaps one last question. This one is for Judy. We noticed that the cash runway estimate, it was previously into second half of 2023 and now it's into 2024. Can you outline some main factors that led to this adjustment?

好的。這就說得通了。也許還有最後一個問題。這是給朱迪的。我們注意到現金跑道的預測，之前是2023年下半年，現在是2024年。您能概述一下導致這項調整的一些主要因素嗎？

Yes. We have a little more specificity internally about the type of trial that we might run in the cost. So we were able to build that in a little more specifically. And as you know, there has been no financing since the last quarter. But we just have some more specific estimates that we've begun working with the CROs and have been doing some planning during the last quarter.

是的。對於我們可能在成本中進行的試驗類型，我們內部有更多的具體性。所以我們能夠更具體地建構它。如您所知，自上個季度以來一直沒有融資。但我們只是有一些更具體的估計，我們已經開始與 CRO 合作，並在上個季度做了一些計劃。

Got it. And I guess, just to confirm that as you could say that your current cash holding is sufficient to see this entire Phase III trial through?

知道了。我想，只是為了確認，正如您所說，您目前持有的現金足以完成整個第三階段試驗？

Right through the Phase III that we plan as well as a resubmission to the FDA.

就在我們計劃的第三階段以及向 FDA 重新提交的過程中。

Okay. Got it. We look forward to your final details of this new Phase III study.

好的。知道了。我們期待您獲得這項新的 III 期研究的最終細節。

That concludes the Q&A session. I will now hand back over to Corey Fishman for any closing remarks. Corey, over to you.

問答環節到此結束。現在我將把閉幕詞交還給科里·菲什曼。科里，交給你了。

Thank you very much. So I just want to take one more moment to say thank you again to all the folks on the call for joining us today. We appreciate the continued support. As stated earlier, we remain very confident in the value of oral sulopenem to treat multidrug-resistant infections. We will continue to work collaboratively with the FDA to provide the additional clinical data requested in the Complete Response Letter that we received in July to support the approval of oral sulopenem as an important treatment option for physicians and patients.

非常感謝。因此，我想再花一點時間再次感謝今天參加我們電話會議的所有人員。我們感謝您的持續支持。如前所述，我們對口服硫培南治療多重抗藥性感染的價值仍然非常有信心。我們將繼續與 FDA 合作，提供我們 7 月收到的完整回覆信中要求的額外臨床數據，以支持批准口服硫培南作為醫生和患者的重要治療選擇。

And perhaps most importantly, we expect our existing cash will allow us to complete the additional development of sulopenem to support, if successful, the resubmission of the NDA to the agency. So we are in a very good position from a cash perspective to get that work done without the need for additional financing. So thanks again to everyone, and have a great day.

也許最重要的是，我們預計現有的現金將使我們能夠完成硫培南的額外開發，以支持（如果成功的話）向該機構重新提交 NDA。因此，從現金角度來看，我們處於非常有利的位置，無需額外融資即可完成這項工作。再次感謝大家，祝您有美好的一天。

Thank you for joining today's call. You may now disconnect.

感謝您參加今天的電話會議。您現在可以斷開連線。