Iterum Therapeutics PLC (ITRM) 2024 Q3 法說會逐字稿

Hello, everyone, and thank you for holding, and welcome to the Iterum Therapeutics' reports third-quarter 2024 financial results. My name is [Ezra], and I will be your coordinator today. (Operator Instructions)

大家好，感謝大家的關注，歡迎收看 Iterum Therapeutics 2024 年第三季財務業績報告。我的名字是[Ezra]，今天我將擔任你們的協調員。（操作員說明）

I will now hand you over to your host, Louise Barrett, Senior Vice President, Legal Affairs. Louise, please go ahead.

現在我將把您交給東道主、法律事務部高級副總裁路易斯·巴雷特 (Louise Barrett)。路易絲，請繼續。

Thank you, Ezra. Good morning, and welcome to Iterum Therapeutics' third-quarter 2024 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，以斯拉。早安，歡迎參加 Iterum Therapeutics 2024 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 our Chief Executive Officer, Corey Fishman; and our Chief Financial Officer, Judy Matthews. Corey will provide some opening remarks, Judy will provide details on our financial results, and then we will open the lines for Q&A.

今天上午，我們的執行長科里·菲什曼 (Corey Fishman) 也加入了我們的行列。和我們的財務長朱迪·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詳細信息，然後我們將開始問答。

Before we begin, I'd 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 therapeutic and market potential of ORLYNVAH; the sufficiency of our cash resources to fund our operating expenses into 2025, including through the repayment date of the exchangeable notes; the listing of patents for ORLYNVAH in the FDA's Orange Book; the protection provided by our patents for ORLYNVAH; and our strategic process to sell license or otherwise dispose off our rights to ORLYNVAH.

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的計劃、策略和業務前景的前瞻性陳述，包括 ORLYNVAH 的治療和市場潛力；我們的現金資源是否足以支付我們到 2025 年的營運費用，包括在可交換票據的償還日期之前； FDA 橙皮書中列出了 ORLYNVAH 的專利；我們為 ORLYNVAH 提供的專利保護；以及我們出售許可或以其他方式處置我們對 ORLYNVAH 的權利的戰略流程。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including, but not limited to, risks and uncertainties concerning the outcome, impact, effects, and results of our evaluation of strategic alternatives, including the terms, timing, structure, value benefits, and costs of any strategic transaction; our ability to complete the strategic transaction; our ability to successfully prepare and implement commercialization plans for ORLYNVAH with a commercial partner or directly if we are unsuccessful at entering into or completing a strategic transaction; the market opportunity for and the potential market acceptance of ORLYNVAH; the accuracy of expectations regarding how far into the future, our cash on hand will fund our ongoing operations; our ability to maintain our listing on the NASDAQ capital market; and other factors discussed under the caption Risk Factors in our quarterly report on Form 10-Q filed with the SEC this morning.

由於我們無法控制的各種因素，包括但不限於與我們策略評估的結果、影響、影響和結果相關的風險和不確定性，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。方案，包括任何策略交易的條款、時間安排、結構、價值效益和成本；我們完成戰略交易的能力；如果我們未能成功達成或完成策略交易，我們有能力與商業合作夥伴或直接成功制定和實施 ORLYNVAH 商業化計劃； ORLYNVAH 的市場機會和潛在市場接受度；關於未來多久我們手頭上的現金將為我們持續營運提供資金的預期的準確性；我們維持在納斯達克資本市場上市的能力；以及我們今天早上向 SEC 提交的 10-Q 表格季度報告中「風險因素」標題下討論的其他因素。

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 obligation to update such statements. We will also be referencing non-GAAP financial measures during the call. We provided a reconciliation of GAAP reported to non-GAAP adjusted information in the press release issued this morning.

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。我們特別聲明不承擔更新此類聲明的義務。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 all said, now I'll turn you over to Corey for your opening remarks.

話雖如此，現在我將請科里致開幕詞。

Thank you, Louise. Good morning, and thanks for joining us today. As we previously announced, we are very excited to have received FDA approval for ORLYNVAH, our oral sulopenem product last month for the treatment of uncomplicated urinary tract infections, caused by the designated microorganisms E coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

謝謝你，路易絲。早安，感謝您今天加入我們。正如我們之前宣布的，我們非常高興上個月獲得FDA 批准ORLYNVAH，這是我們的口服硫培南產品，用於治療成年女性中由指定微生物大腸桿菌、肺炎克雷伯菌或奇異變形桿菌引起的單純性泌尿道感染。

Our approval marks the first US approval of an oral product in the penem class of drugs which is a very potent and safe class of drugs, currently only delivered as intravenous therapy. Having an approved oral penem enables treatment for appropriate patients in the community, where new effective agents are desperately needed.

我們的批准標誌著美國首次批准培南類藥物中的口服產品，培南類藥物是一種非常有效且安全的藥物，目前僅作為靜脈注射治療。擁有經批准的口服青黴烯類藥物可以為社區中迫切需要新有效藥物的適當患者提供治療。

As a potential treatment for patients with uncomplicated urinary tract infections that have limited or no other oral treatment options, ORLYNVAH has the potential to not only effectively treat these patients but also has the opportunity to help combat the growing health crisis of rising antimicrobial resistance by offering a new treatment alternative.

作為一種潛在的治療方法，治療那些缺乏或沒有其他口服治療選擇的單純性泌尿道感染患者，ORLYNVAH 不僅有可能有效治療這些患者，而且有機會透過提供藥物來幫助應對日益嚴重的抗菌藥物抗藥性性日益嚴重的健康危機。

We have received formal communication from the FDA of five additional years of exclusivity under the GAIN Act, meaning that ORLYNVAH has market exclusivity for 10 years from the date of approval or until October 25, 2034. Additionally, our US patent portfolio provides protection for oral sulopenem into 2039 with issued US patents covering both method of use and composition of matter.

我們已收到 FDA 的正式通知，根據 GAIN 法案，ORLYNVAH 擁有從批准之日起或到 2034 年 10 月 25 日止 10 年的市場獨佔權。此外，我們的美國專利組合為口服硫培南提供到 2039 年的保護，已頒發的美國專利涵蓋使用方法和物質成分。

We have also submitted patent information for four US patents for ORLYNVAH, that will be listed in FDA's Orange Book approved drug products with therapeutic equivalence evaluations. Overall, we are very pleased that the amount of protection that ORLYNVAH should have in the US market to capture value without competition from a potential generic product.

我們還提交了 ORLYNVAH 的四項美國專利的專利信息，這些專利將被列入 FDA 橙皮書批准的藥品，並進行治療等效性評估。總體而言，我們非常高興 ORLYNVAH 在美國市場應獲得足夠的保護，以在不受潛在仿製藥競爭的情況下獲取價值。

Now, I'll provide a few comments on why we are so excited about the potential for ORLYNVAH.

現在，我將就為什麼我們對 ORLYNVAH 的潛力如此興奮發表一些評論。

The uncomplicated urinary tract infection market in the US has not had a new oral treatment launched in about 25 years. The leading product in the uncomplicated urinary tract infection market, Nitrofurantoin was approved in 1953 and the majority of the other oral products in the market were approved in the 1970s and 1980s. The use of these products over time has led to rising resistance rates, resulting in the most widely used products having resistance rates approaching 20% and those rates can run as high as 30% or more.

美國的單純性泌尿道感染市場已有約 25 年沒有推出新的口服治療藥物。呋喃妥因是單純性泌尿道感染市場的主導產品，於 1953 年獲得批准，市場上大多數其他口服產品於 20 世紀的 70 年代和 1980 年代獲得批准。隨著時間的推移，這些產品的使用導致抗藥性上升，導致最廣泛使用的產品的抗藥性率接近 20%，甚至可能高達 30% 或更高。

As most prescribing for uncomplicated urinary tract infections occurs empirically, this very high and oftentimes increasing resistance rate creates a challenge for practicing physicians since the efficacy of these products are continuing to be eroded over time. Additionally, almost all of the widely used oral products in this therapy area have some safety concerns that again, create challenges for treating physicians as to their choice of agent to use.

由於大多數治療簡單尿路感染的處方都是憑經驗進行的，這種非常高且常常不斷增加的抗藥性率給執業醫師帶來了挑戰，因為這些產品的功效隨著時間的推移不斷受到侵蝕。此外，該治療領域幾乎所有廣泛使用的口腔產品都存在一些安全問題，這再次給治療醫生選擇使用的藥物帶來了挑戰。

Unfortunately, with almost no innovation in decades, physicians have been forced to use agents that may not work as well as they would like for their patients. With the ORLYNVAH approval, there now could be an alternative treatment option for those patients who have limited or no other oral treatment options available. We believe that there are many patients that fall into this category specifically at-risk patients.

不幸的是，幾十年來幾乎沒有任何創新，醫生被迫使用對患者可能效果不佳的藥物。隨著 ORLYNVAH 的批准，對於那些只有有限或沒有其他口服治療選擇的患者來說，現在可以有一種替代治療選擇。我們相信有許多患者屬於這一類，特別是高風險患者。

We define at-risk patients as women that fall into any of the following categories: women who are 65 years or older, women who have diabetes, women with a history of recurrent or drug-resistant infections, or women that have other comorbidities that negatively impact their immune system. This group of patients are most at risk given their profiles and many physicians are challenged to treat these patients with existing oral options that have substantial resistance as well as safety hurdles.

我們將高風險患者定義為屬於以下任何類別的女性：65 歲或以上的女性、患有糖尿病的女性、有反覆感染或抗藥性感染史的女性，或患有其他合併症的女性。系統。考慮到這類患者的情況，他們面臨的風險最大，許多醫生面臨著用現有的口服藥物治療這些患者的挑戰，這些藥物存在很大的阻力和安全障礙。

Another key group of patients that are in significant need of a new, efficacious, and safe oral treatment alternative are the patients that have pathogens resistant to all commonly used oral antibiotics. In our reassurer uncomplicated urinary tract infection clinical trial, completed earlier this year and conducted exclusively in the US, over almost 1,000 patients we found that approximately 1% of these patients had an isolate that was resistant to all available oral antibiotics.

急需新的、有效的、安全的口服治療替代方案的另一類關鍵患者是對所有常用口服抗生素具有抗藥性的病原體的患者。在今年稍早完成的、僅在美國進行的一項令人放心的簡單尿路感染臨床試驗中，我們對近1,000 名患者進行了試驗，我們發現這些患者中大約1% 的分離株對所有可用的口服抗生素都具有抗藥性。

ORLYNVAH could play an important role in treating these patients as well. We firmly believe that ORLYNVAH has a very important place in the uncomplicated urinary tract infection market for appropriate patients. As we look at our operating plan and go-forward cash runway, we expect to be able to fund our operations into 2025 including through the repayment date of our exchangeable notes due January 31, 2025.

ORLYNVAH 也可以在治療這些患者方面發揮重要作用。我們堅信 ORLYNVAH 在適合病患的單純性泌尿道感染市場中佔有非常重要的地位。當我們審視我們的營運計畫和未來現金跑道時，我們預計能夠為 2025 年的營運提供資金，包括 2025 年 1 月 31 日到期的可交換票據的償還日期為止。

And now I'll turn the call over to Judy Matthews for an update on our financial performance.

現在我將把電話轉給朱迪​​·馬修斯，以了解我們財務表現的最新情況。

Thanks, Corey. Total operating expenses were $4.9 million in the third quarter of 2024, compared to $16.7 million in the third quarter of 2023. Operating expenses include research and development expenses and general and administrative expenses. R&D costs were $3.1 million for the third quarter, compared to $14.9 million for the same period in 2023. The primary driver of the $11.8 million decrease in R&D expense for the third quarter was primarily due to higher costs incurred in 2023 to support our REASSURE trial, which began enrollment in October 2022 and completed enrollment in October 2023.

謝謝，科里。2024 年第三季的總營運費用為 490 萬美元，而 2023 年第三季為 1,670 萬美元。營業費用包括研發費用以及一般及管理費用。第三季研發成本為 310 萬美元，而 2023 年同期為 1,490 萬美元。第三季研發費用減少 1,180 萬美元的主要原因是 2023 年支持我們的 REASSURE 試驗的成本增加，該試驗於 2022 年 10 月開始入組，並於 2023 年 10 月完成入組。

G&A costs were $1.8 million for the third quarter of 2024, which is flat to G&A costs of $1.8 million in the third quarter of 2023.

2024 年第三季的一般管理費用為 180 萬美元，與 2023 年第三季的一般管理費用 180 萬美元持平。

Our net loss on US GAAP basis was $6.1 million for the third quarter of 2024, compared to $3.9 million for the same period in 2023. On a non-GAAP basis, which exclude certain noncash adjustments, our net loss of $4.8 million in the third quarter of 2024, compared to our non-GAAP net loss of $15.7 million in the third quarter of 2023. The $10.9 million decrease in our non-GAAP net loss for the third quarter was primarily a result of lower R&D expenses related to our REASSURE trial.

2024 年第三季度，我們以美國公認會計準則計算的淨虧損為 610 萬美元，而 2023 年同期淨虧損為 390 萬美元。以非公認會計原則（不包括某些非現金調整）計算，我們 2024 年第三季的淨虧損為 480 萬美元，而 2023 年第三季的非公認會計原則淨虧損為 1,570 萬美元。第三季非 GAAP 淨虧損減少 1,090 萬美元，主要是由於 REASSURE 試驗相關的研發費用減少。

At the end of September, we had cash, cash equivalents, and short-term investments of $14.5 million and including warrant exercises and amounts raised under our ATM subsequent to quarter end, we expect to be able to fund operations into 2025, including through the repayment date of the exchangeable notes on January 31, 2025.

截至 9 月底，我們擁有 1,450 萬美元的現金、現金等價物和短期投資，包括認股權證行使和季度末後透過 ATM 籌集的金額，我們預計能夠為 2025 年的營運提供資金，包括透過可交換票據的償還日期為2025年1月31日。

As of November 4, 2024, which includes the shares issued under our ATM and warrant exercises, we had approximately 27.5 million ordinary shares outstanding. Also, we currently have approximately $11.1 million of exchangeable notes outstanding, which can be exchanged at the option of the noteholder for approximately 1.9 million shares. If the notes are not exchanged, we are obligated to pay the note holders $11.1 million plus accrued interest in January 2025.

截至 2024 年 11 月 4 日，包括根據我們的 ATM 和認股權證發行的股票，我們擁有約 2750 萬股已發行普通股。此外，我們目前還有約 1,110 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 190 萬股股票。如果票據未交換，我們有義務在 2025 年 1 月向票據持有人支付 1,110 萬美元以及應計利息。

Further, upon approval of ORLYNVAH, we owed Pfizer, a $20 million regulatory milestone, which has been deferred for two years for issuance of a promissory note as permitted under the terms of our Pfizer License.

此外，在 ORLYNVAH 獲得批准後，我們欠輝瑞 2000 萬美元的監管里程碑，該里程碑已推遲兩年，以根據我們的輝瑞許可證條款允許發行期票。

Now we will take questions.

現在我們將接受提問。

(Operator Instructions) Ed Arce, H.C. Wainwright.

（操作員說明）Ed Arce, H.C.溫賴特。

This is Thomas Yip, asking a couple of questions for Ed. So first, as you earlier in the call, so with now 10 years of market exclusivity up to 2034, can you also discuss how far out the sulopenem portfolio provide coverage for both in the US and maybe in the Europe as well?

我是 Thomas Yip，向 Ed 問了幾個問題。首先，正如您早些時候在電話會議中所說的那樣，現在擁有 10 年的市場獨佔權，直至 2034 年，您能否討論一下硫培南產品組合在美國以及歐洲的覆蓋範圍有多大？

Sure, Thomas. Thanks for the question. So the GAIN Act provides the incremental five years of market exclusivity. And so that's 10 years in total from the date of approval. So that goes into 2034. The patents we have, the latest date of exploration are into 2039 in the US, and they would be the same in other territories that when they're granted, assuming they're granted. So we have patents in the U.S. and in a couple of other territories, we do not have them yet granted in Europe. So we have US coverage into 2039 with patents, and a couple of other territories, including Japan and Australia, but we have not yet been granted European patents.

當然，托馬斯。謝謝你的提問。因此，GAIN 法案提供了增量五年的市場獨佔權。從批准之日起總共有 10 年。這樣就進入 2034 年了。我們擁有的專利，在美國，最新的探索日期是2039年，在其他地區，如果它們被授予的話，它們在其他地區也將是相同的。因此，我們在美國和其他幾個地區擁有專利，但在歐洲尚未授予這些專利。因此，我們的專利涵蓋美國直至 2039 年，以及其他幾個地區，包括日本和澳大利亞，但我們尚未獲得歐洲專利。

Understood. And then can you perhaps discuss ORLYNVAH label as it was approved? Does it meet your internal expectations in terms of how broad it is and also the restrictions anticipated?

明白了。那麼您能否討論一下 ORLYNVAH 標籤獲得批准的情況？它的範圍和預期限制是否符合您的內在期望？

I'm sorry, Thomas, I couldn't hear that.

對不起，湯瑪斯，我聽不到。

What I was asking was the ORLYNVAH label as it was approved. Just wonder, did they meet your internal expectations in terms of how broad it is? And then also the restrictions anticipated?

我問的是 ORLYNVAH 標籤，因為它已獲得批准。只是想知道，他們的範圍是否符合您的內在期望？然後還有預期的限制？

Yeah, sure. It's a good question. Thanks, again. We were very pleased with the label. And I'll tell you exactly what our thoughts were. And I think everyone who has been part of the Iterum story knows that we have always been very consistent in saying this product, we believe, is best suited for folks who are at risk or elevated risk. And having the label that we have, we believe, gives us the opportunity to treat those patients.

是的，當然。這是一個好問題。再次感謝。我們對這個標籤非常滿意。我會確切地告訴你我們的想法。我認為參與 Iterum 故事的每個人都知道，我們一直非常一致地表示，我們相信該產品最適合處於風險或高風險的人。我們相信，擁有我們擁有的標籤使我們有機會治療這些患者。

Unfortunately, in this space, in the complicated urinary tract infection space, our belief is that we're already at a place where most patients have limited oral options available due to resistance, due to safety profiles of the existing drugs and that is really kind of our -- what we thought about and we believe is very appropriate for sulopenem patients.

不幸的是，在這個領域，在複雜的泌尿道感染領域，我們相信，由於現有藥物的安全性，大多數患者由於抗藥性而只能選擇有限的口服藥物，這真是太好了我們的想法和我們相信非常適合硫培南患者。

So we're very, very pleased with the label. We don't have any other unusual restrictions. As I think we mentioned last time, we don't have any unusual post-marketing requirements, standard pediatric studies as well as surveillance, which are standard for all companies -- and antibiotic companies all have surveillance studies to do. So we're very pleased that we feel like this is a very, very competitive label. And given all the dynamics of the market, we believe it's got an opportunity to do very well.

所以我們對這個標籤非常非常滿意。我們沒有任何其他不尋常的限制。正如我想我們上次提到的，我們沒有任何不尋常的上市後要求，標準兒科研究以及監測，這是所有公司的標準 - 抗生素公司都有監測研究要做。所以我們很高興我們覺得這是一個非常非常有競爭力的品牌。考慮到市場的所有動態，我們相信它有機會做得很好。

Got it. And then perhaps one last question from us. I wonder if you can discuss what's your impression so far on your discussions on the strategic options to date?

知道了。也許我們還有最後一個問題。我不知道您能否談談您對迄今為止的戰略選擇討論的印象？

Sorry, one more time, Thomas?

對不起，再來一次，湯瑪斯？

BD, he's talking about BD.

BD，他說的是BD。

BD? Yeah. So we have --

BD？是的。所以我們有--

Yes.

是的。

We've renewed our process along with our financial adviser with regard to outreach to companies in an effort to achieve a strategic transaction. And that process, obviously, we're just getting the approval, we just kicked it off in terms of renewing that effort. And we'll be monitoring that as we go forward.

我們與財務顧問一起更新了與公司聯繫的流程，以努力實現策略交易。顯然，這個過程我們剛剛獲得批准，我們才剛開始重新進行這項工作。我們將在前進過程中對其進行監控。

Okay. Got it. Thank you again for taking the questions, and looking forward to updates on your [strategic] options.

好的。知道了。再次感謝您提出問題，並期待您的[策略]選擇的更新。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Thanks for taking the questions. Just from a partnering or acquirer perspective, given that your -- the last Phase 3, it was only in the US, would they need another trial in EU, China, Japan, or some other region to extend approvals ex US? Or is the data sufficient with what you have?

感謝您提出問題。僅從合作夥伴或收購方的角度來看，考慮到最後的第三階段僅在美國進行，他們是否需要在歐盟、中國、日本或其他一些地區進行另一次試驗才能將批准擴展到美國以外的地區？或者你所擁有的數據夠嗎？

Yes. Thanks, Jason, for the question. Appreciate it. It's a good question. Our understanding is that in the EU, if you go down that regulatory pathway, you can file with the current data package. They have a very standard process with check-in points and day 120 questions and day 180 questions. So it's kind of a very regulated process, much like it is here. And you do not need another study.

是的。謝謝傑森的提問。欣賞它。這是一個好問題。我們的理解是，在歐盟，如果您遵循監管途徑，則可以使用當前的資料包進行歸檔。他們有一個非常標準的流程，包括簽到點、第 120 天的問題和第 180 天的問題。所以這是一個非常受監管的過程，就像這裡一樣。而且您不需要另一項研究。

My understanding is in China, and Mainland China as well as in Japan, you would need an additional study in local population. So I think you have opportunity everywhere for that, but it would require a little bit more time in China and Japan. I think the majority of the rest of the world has the ability to use the FDA data, and those are the two bigger countries that I believe are requiring a local clinical trial in -- for potential approval.

我的理解是在中國，中國大陸以及日本，你需要對當地人口進行額外的研究。所以我認為你在任何地方都有機會做到這一點，但在中國和日本需要更多的時間。我認為世界上大多數其他國家都有能力使用 FDA 的數據，而我認為這兩個較大的國家需要進行本地臨床試驗以獲得潛在的批准。

And -- thank you, and just one more. For any potential partner or suitor or otherwise, you did have -- I know the trial missed and complicated and surgical. But the data was still very good, kind of vary in a similar vein to the uncomplicated UTI. Do you think that would potentially make this more attractive? Could they leverage that data and do just another study like you did to get approval for uUTI? Is that a part of the discussions that you're having? Or is it just really they're interested potentially uncomplicated only?

還有——謝謝，還有一點。對於任何潛在的合作夥伴或追求者或其他人來說，你確實有——我知道試驗失敗了，而且很複雜，而且需要手術。但數據仍然非常好，與簡單的泌尿道感染類似。您認為這可能會使其更具吸引力嗎？他們能否利用這些數據並像您一樣進行另一項研究來獲得 uUTI 的批准？這是你們討論的一部分嗎？或者他們真的只是對簡單的事情感興趣？

Yeah. I think it's a great question. And I do think there is some interest in complicated UTI as a step-down drug. Again, we obviously didn't hit that endpoint but to your point, now that you're approved in order to get a formal approved indication, you would need to do only one study.

是的。我認為這是一個很好的問題。我確實認為人們對複雜性泌尿道感染作為降血壓藥物有一定的興趣。再說一次，我們顯然沒有達到那個終點，但就你的觀點而言，既然你已經獲得批准以獲得正式批准的適應症，你只需要進行一項研究。

And I believe based on the data that we generated, we have a very good understanding of what that study would look like, who the comparator would be. And I think we would have a very good chance of hitting that end point. And I do think counterparties might be very interested in that because, again, I think that's where the value is in the oral.

我相信，根據我們產生的數據，我們對這項研究的內容以及比較者是誰有很好的了解。我認為我們很有可能會達到這個終點。我確實認為交易對手可能對此非常感興趣，因為我再次認為這就是口頭的價值。

It's not so much to have another IV because there are lots of IVs out there. But there's very few orals that I think physicians are feeling comfortable not only in the community but in the hospital to send patients home. So I do think that could be another area of interest for companies depending on what their portfolios look like.

再次進行靜脈注射並不重要，因為那裡有很多靜脈注射。但我認為，無論是在社區還是在醫院，醫生都很少有讓病人感到舒服的送病人回家的機會。因此，我確實認為這可能是公司感興趣的另一個領域，這取決於他們的投資組合。

Got it. Thanks for taking the question.

知道了。感謝您提出問題。

Thank you very much, Jason, and everyone for participating in the question-and-answer session. That marks the end of our questions-and-answer session. I will now hand back over to Corey for any closing remarks.

非常感謝 Jason 和大家參與問答環節。這標誌著我們的問答環節結束。現在我將把閉幕詞交還給科里。

Thanks very much. So we appreciate you all joining us today, and we want to reiterate that we're very excited to have received approval of ORLYNVAH. And along with our financial advisers, as I just mentioned, we have renewed our process of outreach to potential partners in an effort to achieve a strategic transaction with the goal of maximizing value for our stakeholders. And that process is underway and ongoing. So, we appreciate your interest and your time, and thanks very much, and have a great day.

非常感謝。因此，我們感謝大家今天加入我們，我們想重申，我們非常高興獲得 ORLYNVAH 的批准。正如我剛才提到的，我們與我們的財務顧問一起更新了與潛在合作夥伴的聯繫流程，以努力實現策略交易，從而為我們的利害關係人實現價值最大化。這個過程正在進行中並持續進行。因此，我們感謝您的關注和您的時間，非常感謝，祝您有美好的一天。

Thank you very much, Corey, and thank you, everyone, for joining. That ends today's conference call. You may now disconnect your --

非常感謝你，科里，也感謝大家的加入。今天的電話會議到此結束。您現在可以斷開您的—