Iterum Therapeutics PLC (ITRM) 2023 Q3 法說會逐字稿

Hello, everyone, and welcome to the Iterum Therapeutics third-quarter 2023 financial results and business update. My name is Harry, and I'll be your operator today. (Operator Instructions) And I will now hand the call over to Louise Barrett, Senior Vice President, Legal Affairs. To begin, please go ahead.

大家好，歡迎閱讀 Iterum Therapeutics 2023 年第三季財務業績和業務更新。我叫哈利，今天我將成為您的接線生。 （操作員指示）我現在將電話轉交給法律事務資深副總裁 Louise Barrett。首先，請繼續。

Thank you, Harry. Good morning, and welcome to Iterum Therapeutics' third-quarter 2023 financial results and business update conference call. A press release with our third-quarter results was issued earlier this morning and can be fined on our website. We are joined this morning by Corey Fishman, CEO, and Judy Matthews, CFO. Cory will provide some opening remarks, Judo will provide details on our financial results, and then we'll open the lines for Q&A.

謝謝你，哈利。早安，歡迎參加 Iterum Therapeutics 2023 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罰款。今天上午，執行長科里·菲什曼 (Corey Fishman) 和財務長朱迪·馬修斯 (Judy Matthews) 也加入了我們的行列。 Cory 將發表一些開場白，Judo 將提供有關我們財務業績的詳細信息，然後我們將開始問答環節。

In addition, we'll be extending the Q&A portion to answer a few questions we've been routinely receiving from some of our shareholders. Before we begin, I would like to remind you that some of the information presented on this conference call today will contain forward-looking statements concerning our plans, strategies and prospects for our business, including the development, therapeutic and market potential levels, will depend on the timing and results of top line data from our REASSURE clinical trial, our ability to address its deficiencies set out in the complete response letter received from the FDA in July 2021, the expected timing of resubmission of our NDA and timing of review of the NDA by the FDA.

此外，我們將擴展問答部分，以回答我們經常從一些股東那裡收到的一些問題。在我們開始之前，我想提醒您，今天的電話會議上提供的一些資訊將包含有關我們業務的計劃、策略和前景的前瞻性陳述，包括開發、治療和市場潛力水平，將取決於關於我們REASSURE臨床試驗的主要數據的時間和結果、我們解決2021 年7 月從FDA 收到的完整答覆信中列出的缺陷的能力、重新提交NDA 的預期時間以及審查的時間FDA 的 NDA。

The term and coverage provided by our patents, the sufficiency of our cash resources and evaluation of corporate strategic and financing strategies and alternatives to fund future development operations, including the issue of new shares for cash.

我們的專利提供的期限和覆蓋範圍、我們現金資源的充足性以及對公司策略和融資策略的評估以及為未來發展業務提供資金的替代方案，包括發行現金新股。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control, including uncertainties inherent in the design, initiation and conduct of clinical and nonclinical development, availability and timing of data from the REASSURE clinical trial, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential resubmission of our NDA for (inaudible)

由於我們無法控制的各種因素，包括設計、臨床和非臨床開發的啟動和實施、REASSURE 臨床試驗數據的可用性和時間安排中固有的不確定性，實際結果可能與這些前瞻性陳述所示的結果存在重大差異、監管要求或監管機構決定的變更、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 NDA（聽不清楚）

Changes in public policy or legislation, the accuracy of our expectations regarding how far into the future, our cash-in-hand will fund ongoing operations risk and uncertainties concerning the outcome impact facts and results of our evaluation of financing alternatives to fund future development operations, including the terms, timings, structure, value benefits and costs of any such alternatives under our ability to complete with it all.

公共政策或立法的變化、我們對未來多久的預期的準確性、我們手頭上的現金將為持續運營提​​供資金的風險和不確定性，涉及結果影響事實和我們對資助未來開發運營的融資替代方案的評估結果，包括我們有能力完成這一切的任何此類替代方案的條款、時間表、結構、價值效益和成本。

Our ability to maintain our listing on the NASDAQ capital market and other factors included and discussed under the caption risk factors in our quarterly report on Form 10-Q filed with the SEC today. 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, and we specifically disclaim any obligation to update such statements.

我們維持在納斯達克資本市場上市的能力以及其他因素在我們今天向 SEC 提交的 10-Q 表格季度報告中的風險因素標題下進行了討論。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截至任何後續日期的觀點，並且我們特別不承擔更新此類陳述的義務。

We will also be referencing non-GAAP financial measures during the call. We provide a reconciliation of GAAP reported non-GAAP adjusted information in the press release issued this morning. That said, I'll turn it over to you now, Corey, for your opening remarks.

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 報告的非 GAAP 調整資訊的調整表。也就是說，科里，我現在將其交給您進行開場白。

Thanks, Louise. Welcome and thanks for joining us today, I want to share some exciting highlights about the business and our ongoing activities.

謝謝，路易絲。歡迎並感謝您今天加入我們，我想分享一些有關業務和我們正在進行的活動的令人興奮的亮點。

Let's begin by talking a bit about our upcoming key milestones and associated timing. Overall, we want to share with you that the timing for these key milestones has been moved forward by an entire quarter versus our previous guidance. We are very pleased to report then in October, we completed enrollment in our pivotal Phase 3 trial of oral Sulopenem for the treatment of uncomplicated urinary tract infections in adult women, our REASSURE clinical trial.

讓我們先討論一下即將到來的關鍵里程碑和相關的時間表。總的來說，我們想與您分享的是，與我們之前的指導相比，這些關鍵里程碑的時間已經提前了整整一個季​​度。我們非常高興地在十月份報告，我們完成了口服硫培南用於治療成年女性單純性尿路感染的關鍵 3 期試驗，即我們的 REASSURE 臨床試驗的入組。

The REASSURE trial completed enrollment in just 12 months, which is quite remarkable given how long it takes uncomplicated urinary tract infection studies to complete enrollment from our experience and based on other recent uUTI studies. With enrollment in the REASSURE trial complete, our next key milestone will be reporting top line data, which we now expect will occur early in the first quarter of 2024.

REASSURE 試驗僅用了 12 個月就完成了入組，根據我們的經驗以及最近的其他 uUTI 研究，考慮到簡單的尿路感染研究需要多長時間才能完成入組，這是相當了不起的。隨著 REASSURE 試驗的註冊完成，我們的下一個關鍵里程碑將是報告頂線數據，我們現在預計將在 2024 年第一季初出現。

Subject to our analysis of the data, we expect to resubmit our NDA to the FDA in the second quarter of 2024, provided that our resubmission addresses the deficiencies identified in our complete response letter. We expect the FDA to complete its review and take action six months from the date of resubmission or in the fourth quarter of 2024.

根據我們對數據的分析，我們預計將在 2024 年第二季度向 FDA 重新提交 NDA，前提是我們的重新提交能夠解決完整回覆信中發現的缺陷。我們預計 FDA 將在重新提交之日起六個月內或 2024 年第四季完成審查並採取行動。

Now I'd like to take a moment and share the results of our interim analysis and the impact on our overall enrollment. As previously announced, once we achieved our halfway point of enrollment. The blinded interim analysis was conducted by an independent data monitoring committee to determine whether a sample size adjustment was recommended.

現在我想花點時間分享我們的中期分析結果以及對我們整體招生的影響。正如之前宣布的，一旦我們達到了註冊的一半點。獨立資料監測委員會進行了盲法中期分析，以確定是否建議調整樣本量。

The interim analysis showed that based on the blinded data review, we were within the 80% to 90% power range outlined in our special protocol assessment agreement with the FDA. We chose to enroll an additional 263 patients for a total of 2,229 patients, in order to finish the study with a power figure towards the top end of that range based on the blinded data. Importantly, we were able to add these incremental patients and still complete enrollment in the trial of full quarter ahead of our previous guidance.

中期分析顯示，根據盲法資料審查，我們處於與 FDA 的特殊協議評估協議中概述的 80% 至 90% 功效範圍內。我們選擇另外招募 263 名患者，總計 2,229 名患者，以便根據盲法數據以接近該範圍上限的功效數字來完成研究。重要的是，我們能夠添加這些增量患者，並且仍然比我們之前的指導提前完成整個季度的試驗註冊。

On the patent front, we are happy to inform you that we continue to enhance our patent estate, which provides a substantial runway to protect the value of oral Sulopenem in the US and other countries. In this quarter, we have been granted a patent in career directed to the composition of the bilayer tablet of oral Sulopenem.

在專利方面，我們很高興地通知您，我們將繼續增強我們的專利權，這為保護口服硫培南在美國和其他國家的價值提供了堅實的基礎。本季度，我們獲得了一項針對口服舒培南雙層片成分的職業專利。

This patent is scheduled to expire no earlier than 2039. Additionally, we were granted a patent in Australia, which is also directed to the composition of the bilayer tablet of oral Sulopenem and its related uses. As a reminder, in addition to the newly granted Korean and Australian patents and our in-license patents, interim owns two US patents for all oral Sulopenem and the Japanese patents all expiring in 2039, barring any extensions.

該專利預計將於 2039 年到期。此外，我們在澳洲獲得了一項專利，該專利也針對口服舒培南雙層片的成分及其相關用途。提醒一下，除了新授予的韓國和澳洲專利以及我們的授權專利外，Interim 還擁有所有口服磺培南的兩項美國專利和日本專利，均將於 2039 年到期，禁止任何延期。

One US patent and the Japanese patent is directed to the composition of the bilayer tablet and its related preparations and or uses. And the other US patent is directed to the method of use of oral Sulopenem in treating multiple diseases, including uncomplicated urinary tract infections. Additionally, we have a number of pending patent applications in the US and other jurisdictions, including Europe and China.

一項美國專利和一項日本專利涉及雙層片劑的組合物及其相關製劑和/或用途。另一項美國專利涉及使用口服Sulopenem治療多種疾病的方法，包括簡單的泌尿道感染。此外，我們在美國和其他司法管轄區（包括歐洲和中國）還有許多正在申請的專利。

As of September 30, we had cash and cash equivalents of $36 million. Based on our current operating plan, we expect that our current cash, cash equivalents and short-term investments will be able to fund our operations into the third quarter of 2024. Therefore, given our accelerated timeline, we expect our existing cash to be able to fund operations through the top line data readout as well as a potential NDA resubmission.

截至 9 月 30 日，我們擁有現金和現金等價物 3,600 萬美元。根據我們目前的營運計劃，我們預計我們目前的現金、現金等價物和短期投資將能夠為我們的營運提供資金直至2024 年第三季。因此，鑑於我們加速的時間表，我們預計我們現有的現金能夠透過頂線數據讀出以及潛在的 NDA 重新提交來資助營運。

In summary, we are very pleased to have completed enrollment well ahead of our previous guidance and are looking forward to our upcoming milestones on the accelerated time line I have just laid out for you. As mentioned, based on our current projections, we expect to have the cash on hand to fund operations through top line data readout and the potential resubmission of our NDA. We continue to explore opportunities to efficiently and cost effectively raise capital to ensure that we can fund operations into the future.

總而言之，我們很高興能夠提前完成註冊，並期待在我剛剛為您制定的加速時間表上實現即將到來的里程碑。如前所述，根據我們目前的預測，我們預計將有現金透過頂線數據讀出和可能重新提交我們的 NDA 來為營運提供資金。我們繼續探索高效且具有成本效益的籌集資金的機會，以確保我們能夠為未來的營運提供資金。

Lastly, we remain excited about potentially bringing the first new oral treatment for uncomplicated urinary tract infections to the market in the US in over 20 years.

最後，我們仍然對可能將 20 多年來第一種治療單純性泌尿道感染的新型口服藥物推向美國市場感到興奮。

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, Cory. Total operating expenses were $16.7 million in the third quarter 2023, compared to $7 million in the third quarter 2022. Operating expenses include research and development expenses and general and administrative expenses. R&D costs were $14.9 million for the third quarter compared to $4.4 million for the same period in 2022.

謝謝，科里。 2023 年第三季的總營運費用為 1,670 萬美元，而 2022 年第三季的營運費用為 700 萬美元。營運費用包括研發費用以及一般和管理費用。第三季研發成本為 1,490 萬美元，而 2022 年同期為 440 萬美元。

The primary driver of the increase in R&D expense for the third quarter was cost to support our REASSURE trial, which began enrollment in October 2022, and completed enrollment last month. G&A costs were $1.8 million for the third quarter of 2023, which is $900,000 lower than G&A costs of $2.7 million in the third quarter of 2022, due primarily to lower share-based compensation expense and a decrease in legal fees incurred in connection with the lawsuit filed in August 2021, which was dismissed with prejudice in January 2023, which means the case cannot be brought back the quarter.

第三季研發費用增加的主要驅動因素是支持我們的 REASSURE 試驗的成本，該試驗於 2022 年 10 月開始入組，並於上個月完成入組。 2023 年第三季的一般管理費用為 180 萬美元，比 2022 年第三季的一般管理費用 270 萬美元減少了 90 萬美元，這主要是由於股權激勵費用減少以及與訴訟相關的法律費用減少該訴訟於2021 年8 月提起，並於2023 年1 月因偏見被駁回，這意味著該案無法在本季恢復。

Our net loss on a US GAAP basis was $3.9 million for the third quarter of 2023, and $29.1 million for the same period in 2022. On a non-GAAP basis, which excludes certain noncash adjustments, our net loss of $15.7 million in the third quarter 2023, compared to our non-GAAP net loss of $5.3 million in the third quarter of 2022.

以美國公認會計準則計算，我們2023 年第三季的淨虧損為390 萬美元，2022 年同期為2,910 萬美元。以非公認會計準則計算，不包括某些非現金調整，我們第三季的淨虧損為1,570 萬美元。2023 年第三季的淨虧損為 530 萬美元，而 2022 年第三季的非 GAAP 淨虧損為 530 萬美元。

The $10.4 million increase in our non-GAAP net loss for the third quarter was primarily a result of higher R&D expenses related to our REASSURE trials. At the end of September, we had cash, cash equivalents and short-term investments of $35.9 million, which based on our current operating plan, will provide a cash runway into the third quarter of 2024.

第三季非 GAAP 淨虧損增加 1,040 萬美元，主要是由於 REASSURE 試驗相關的研發費用增加。截至 9 月底，我們的現金、現金等價物和短期投資為 3,590 萬美元，根據我們目前的營運計劃，將為 2024 年第三季提供現金跑道。

We expect to report top line data early in the first quarter of 2024. And if the REASSURE trial is successful, we expect to resubmit to the FDA, the NDA for oral Sulopenem for the treatment of uUTI in the second quarter of 2024, provided that the resubmitted NDA addresses all of the deficiencies identified in the CRL.

我們預計將在 2024 年第一季初報告頂線數據。如果 REASSURE 試驗成功，我們預計將在 2024 年第二季度向 FDA 重新提交口服硫培南治療 uUTI 的 NDA，前提是：重新提交的NDA 解決了CRL 中發現的所有缺陷。

We expect that the FDA will complete its review and take action six months from the date the FDA received the resubmitted NDA or during the fourth quarter of 2024. As of September 30, 2023, we had approximately 13 million ordinary shares outstanding.

我們預計FDA 將在FDA 收到重新提交的NDA 之日起六個月內或在2024 年第四季期間完成審查並採取行動。截至2023 年9 月30 日，我們擁有約1,300 萬股已發行普通股。

Also, as of the end of September, we had approximately $12.6 million of exchangeable notes outstanding, which can be exchanged at the option of the noteholder for approximately 1.1 million shares. If the notes are not exchanged, we will pay the note holders $12.6 million plus accrued interest in January 2025. Operator, please open the line for questions.

此外，截至 9 月底，我們還有約 1,260 萬美元的未發行可交換票據，票據持有人可以選擇將其兌換為約 110 萬股股票。如果不交換票據，我們將在 2025 年 1 月向票據持有人支付 1,260 萬美元以及應計利息。接線員，請撥打電話提問。

Thank you. We will now take questions from the audience.

謝謝。現在我們將回答觀眾的提問。

Ed Arce, H.C. Wainwright.

埃德·阿爾塞，H.C.溫賴特。

Hi, good morning. This is Thomas Yip asking a couple of questions for Ed. Thank you so much for the kind of questions. So, first, perhaps a discussion for the Phase 2 study with over 2,200 patients enrolled versus the target of 1966 and also Korea, as you mentioned earlier, one quarter ahead, very impressive. Can you discuss what the main drivers of this open enrollment and also accelerated pace was some initial feedback for this study?

早安.我是 Thomas Yip，向 Ed 問了幾個問題。非常感謝您提出此類問題。因此，首先，也許是關於2,200 多名患者入組的2 期研究的討論，與1966 年的目標相比，還有韓國，正如您之前提到的，提前了四分之一，非常令人印象深刻。您能否討論一下這項開放招生和加快步伐的主要驅動力是什麼？這項研究的一些初步回饋是什麼？

Yes. Thanks for the question, Thomas. The interim analysis was the real driver in terms of determining power. That's a very complicated. It was blinded. Of course, and it was a very complicated as all the interim analyses are set of analyses based on a variety of factors, including actual data and understanding where our power calculation was.

是的。謝謝你的提問，托馬斯。中期分析是決定力量的真正驅動力。這是一個非常複雜的事情。它被蒙蔽了。當然，這是一個非常複雜的過程，因為所有中期分析都是基於各種因素的分析，包括實際數據和理解我們的功率計算情況。

And what the reason we overenrolled, as you say, is we wanted to be at the higher end of that power calculation, which was between 80% and 90% per our SPA agreement with the FDA. So, we were able to do that in a very efficient manner and keep that timeline to basically one year for full enrollment, but we took that opportunity to increase the power, or the expected power of the study based on the data from interim analysis.

正如您所說，我們超額註冊的原因是我們希望達到功率運算的高端，根據我們與 FDA 的 SPA 協議，該功率計算在 80% 到 90% 之間。因此，我們能夠以非常有效的方式做到這一點，並將完全註冊的時間表基本上保持在一年，但我們利用這個機會增加了研究的力量，或者根據中期分析的數據提高了研究的預期力量。

Got it. And then trying to narrow down the early first quarter 2024, readout timeline a little bit? Or would this be a kind of January or late January, February timeframe?

知道了。然後試著縮小 2024 年第一季初的範圍，稍微縮小讀出時間表？或者這會是一月或一月底、二月的時間範圍嗎？

Yeah. We we're obviously still working on that we don't have any definitive date other than we believe it will be earlier in the quarter versus later in the quarter.

是的。我們顯然仍在研究，除了我們認為將在本季度早些時候而不是本季度晚些時候之外，我們沒有任何確定的日期。

Understood, understood. Let's Just one more question from us or we've seen us she announce multiple new patent issue both in US and ex-US. Can discuss where some actions (inaudible) for ex U.S. markets?

明白了，明白了。讓我們再問一個問題，或者我們已經看到她在美國和美國以外地區宣布了多項新專利問題。可以討論針對美國以外市場的一些行動（聽不清楚）嗎？

Yeah, we will start looking at those conversations, when we have our data in terms of ex US, we know that the market is very large and we know that the majority of prescribing for oral products is in a handful, just like it is in the US, a handful of therapies.

是的，我們將開始關注這些對話，當我們獲得美國以外的數據時，我們知道市場非常大，我們知道大多數口服產品的處方都在少數，就像在美國一樣美國有一些療法。

And so what we really have to do is get the data, determine the best route of conversation for potential partnerships outside the US and then begin those conversations in earnest. The good news is the market is very large, there's I don't remember the exact number, but somewhere around 15 million or 17 million infections for uncomplicated UTI is what used to be called the Big Five.

因此，我們真正要做的就是獲取數據，確定美國以外潛在合作夥伴的最佳對話途徑，然後認真開始這些對話。好消息是市場非常大，我不記得確切的數字，但大約有 1500 萬或 1700 萬單純性尿路感染感染者，這就是過去所謂的「五大」。

And so, we know that there is an opportunity there. It's just a question of having conversations with partners who are appropriate to make sure that we can optimize what we have outside of the US as well.

因此，我們知道那裡有機會。這只是與合適的合作夥伴進行對話的問題，以確保我們也能優化我們在美國以外的業務。

Understood. Thank you again for taking your questions and we look forward to the data readout in first quarter.

明白了。再次感謝您提出問題，我們期待第一季的數據公佈。

Thanks, Thomas.

謝謝，托馬斯。

Thank you. And we have no further questions on the line today. So, I'd like to hand back to Louise Barrett to continue.

謝謝。今天我們沒有其他問題了。因此，我想請路易絲·巴雷特 (Louise Barrett) 繼續。

Great. Thanks, Harry. At this time, Corey and Judy will take questions that we've been receiving from some of our shareholders. And so, Cory, first question for you.

偉大的。謝謝，哈利。此時，科里和朱迪將回答我們從一些股東收到的問題。所以，科里，你的第一個問題。

When do you expect that oral Sulopenem will be approved?

您預計口服硫培南什麼時候會獲得批准？

Thanks, Louise. We expect, as we mentioned, to report top line data in the early part of Q1 and then subject to our analysis of that data would expect to resubmit the NDA to the FDA in the second quarter of 2024, provided that our resubmission does address the deficiencies that were identified in our complete response letter, we would expect the time line the FDA to operate under would be to complete its review and take action six months from the date of that resubmission and therefore, a potential approval would occur in the fourth quarter of 2024.

謝謝，路易絲。正如我們所提到的，我們預計將在第一季初期報告頂線數據，然後根據我們對該數據的分析，預計將在2024 年第二季度向FDA 重新提交NDA，前提是我們的重新提交確實解決了以下問題：鑑於我們在完整回覆信中發現的缺陷，我們預計FDA 的運作時間表將是自重新提交之日起六個月內完成審查並採取行動，因此，可能會在第四季度獲得批准2024 年。

Great. Thanks, Corey. And one for you Judy and how long can the company operate with it earn cash on hand?

偉大的。謝謝，科里。朱迪，還有一份給你的，公司用它經營多久可以賺到現金？

Yeah, thanks, Louise. Yeah, based on our current productions, our cash on hand is sufficient to allow us to operate into the third quarter of 2024. As we said, that should allow us to fund our operations through the top line data as well as the NDA resubmission. However, additional funds are needed to get to approval in the fourth quarter.

是的，謝謝，路易絲。是的，根據我們目前的產量，我們手頭上的現金足以讓我們運營到 2024 年第三季度。正如我們所說，這應該使我們能夠透過頂線數據以及重新提交 NDA 來為我們的營運提供資金。然而，需要額外的資金才能在第四季度獲得批准。

Great. Thank you. And so, Corey, Judy has talked about cash runway. What about the long-term financing strategy of the company. Can you talk to us a little bit about that?

偉大的。謝謝。因此，科里、朱迪談到了現金跑道。公司的長期融資策略如何？您能和我們談談嗎？

Sure. And thanks. Thanks for the question, investors. Because this is one, we get quite frequently, and we want to address it head-on. We're constantly evaluating a variety of financing strategies to ensure that we can continue to fund operations through '24 and over the next few years.

當然。謝謝。謝謝投資人的提問。因為這是我們經常遇到的問題，我們希望正面解決它。我們不斷評估各種融資策略，以確保我們能夠繼續為 24 年及未來幾年的營運提供資金。

One such strategy is to take advantage of opportunities to raise capital through share issuances or cash. As we've discussed previously, as an Irish incorporated company, our shareholders must approve the disapplication of statutory preemption rights over the authorized, but on issued share capital, including the additional ordinary shares that were approved at the Annual General Meeting in May.

其中一種策略是利用機會透過發行股票或現金籌集資金。正如我們之前討論的，作為一家在愛爾蘭註冊成立的公司，我們的股東必須批准對授權但已發行股本（包括 5 月份年度股東大會批准的額外普通股）不適用法定優先購買權。

And this is otherwise known as the waiver of preemption rights. This waiver provides us with the ability to more efficiently and cost effectively access the capital necessary to continue to execute on our business plan and strategy. Without this waiver, our ability to raise additional capital for cash is severely limited under our existing authority, which did not cover the new shares that were approved at the Annual General Meeting in May.

這也稱為放棄優先購買權。這項豁免使我們能夠更有效、更具成本效益地獲得繼續執行我們的業務計劃和策略所需的資本。如果沒有這項豁免，我們籌集額外現金資本的能力將在我們現有的授權下受到嚴重限制，這不包括五月年度股東大會上批准的新股。

As you may know, we did ask shareholders to approve this waiver earlier this year at our Annual General Meeting and at a subsequent extraordinary meeting in August. And while we received over 60% support of the vote on both occasions, we did not receive the affirmative vote of at least 75% of the votes cast as is required under Irish law.

如您所知，我們確實在今年稍早的年度股東大會和隨後於八月舉行的特別會議上要求股東批准這項豁免。雖然我們兩次都獲得了超過 60% 的選票支持，但我們並未按照愛爾蘭法律的要求獲得至少 75% 的選票支持。

Simply stated, without this waiver extending to all authorized and uninsured shares, in order to issue shares and raise sufficient capital in the equity markets, we'd be required to either seek a transaction-specific waiver from shareholders every time we want to issue shares that would entail an extraordinary general meeting each time and significantly impede the timing of a financing transaction and our likely ability to do a deal efficiently or at all.

簡而言之，如果沒有將這項豁免擴大到所有授權和未投保的股票，為了發行股票並在股票市場籌集足夠的資金，我們每次想要發行股票時都需要向股東尋求特定於交易的豁免這將導致每次都需要召開特別股東大會，並嚴重阻礙融資交易的時間表以及我們有效或根本無法完成交易的能力。

Alternatively, we can attempt to issue shares through a rights offering by first offering the shares to all existing shareholders for a period of time and then perhaps finding additional investors willing to take any shares that are not subscribed for on the same terms as the rights offer.

或者，我們可以嘗試透過配股發行股票，首先在一段時間內向所有現有股東發行股票，然後尋找願意以與配股發行相同的條款購買任何未認購股份的其他投資者。

The rights offering is also quite time-consuming, costly, and there can be no guarantee that we would raise sufficient capital via this process. We strongly believe that having the flexibility to quickly take advantage of opportunities to raise capital through share issuances for cash in order to fund the continued execution of our business plans and strategies is critical to interim success and our ability to bring oral Sulopenem, if approved to market.

配股也相當耗時、成本高昂，並且不能保證我們能夠透過這個過程籌集足夠的資金。我們堅信，能夠靈活地快速利用透過發行現金股票籌集資金的機會，為我們業務計劃和戰略的持續執行提供資金，這對於取得暫時的成功至關重要，並且如果獲得批准，我們也有能力提供口服硫培南。市場。

While we will also continue to pursue other corporate strategic financial and financing alternatives, including partnerships and debt financings, we plan to go back to you our shareholders in the near future seek approval for the waiver of preemption rights over a portion of the authorized, but on issued shares.

雖然我們也將繼續尋求其他企業策略財務和融資替代方案，包括合作夥伴關係和債務融資，但我們計劃在不久的將來向我們的股東尋求批准放棄部分授權的優先購買權，但關於已發行的股票。

Great. Thanks, Corey. That's all the questions for now. So, I'll pass it back to you Corey, just for your closing remarks.

偉大的。謝謝，科里。這就是目前所有的問題。所以，我會把它傳回給你，科里，供你作結語。

Great. Thank you, Louise. Thanks for joining us today. We've taken the opportunity to address some of the questions we get most frequently from investors in order to provide as much clarity as we can regarding our upcoming milestones and timelines and to reiterate the importance of obtaining a waiver of preemption rights from shareholders with regard to the long term financing of the company.

偉大的。謝謝你，路易絲。感謝您今天加入我們。我們藉此機會回答了投資者最常提出的一些問題，以便盡可能澄清我們即將到來的里程碑和時間表，並重申獲得股東放棄優先購買權的重要性以利於公司的長期融資。

We continue to remain confident in the value of oral Sulopenem to treat multidrug resistant infections in the community. We look forward to our upcoming top line data readout and subject to our analysis of the data resubmitting our NDA to the FDA for this important treatment option for physicians and patients. Thanks again for joining us today and have a good day.

我們仍然對口服硫培南治療社區多重抗藥性感染的價值充滿信心。我們期待即將公佈的頂線數據，並根據我們對數據的分析，向 FDA 重新提交我們的新藥申請 (NDA)，以獲得對醫生和患者來說這一重要的治療選擇。再次感謝您今天加入我們，祝您有美好的一天。

This concludes today's call. Thank you all for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝大家的加入。現在您可以斷開線路。