Iterum Therapeutics PLC (ITRM) 2025 Q2 法說會逐字稿

Good morning. Thank you for attending today's Iterum Therapeutics' second-quarter 2025 financial results and business update call. My name is Megan and I'll be your moderator for today.

早安.感謝您參加今天的 Iterum Therapeutics 2025 年第二季財務業績和業務更新電話會議。我叫梅根，今天我將擔任你們的主持人。

(Operator Instructions)

（操作員指示）

I would now like to pass the conference over to Kevin Dalton, Senior Director, Legal Affairs. Thank you. You may proceed.

現在，我想將會議交給法律事務高級總監 Kevin Dalton。謝謝。您可以繼續。

Thank you, speaker. Good morning and welcome again to Iterum Therapeutics' second-quarter 2025 financial results and business update conference call. A press release with our second-quarter results was issued earlier this morning and can be found on our website.

謝謝您，議長。早安，再次歡迎參加 Iterum Therapeutics 2025 年第二季財務業績和業務更新電話會議。我們今天早上發布了有關第二季度業績的新聞稿，可以在我們的網站上查閱。

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 and Judy will provide details on our financial results and an update on the finance related proposals at our upcoming 2025 Annual General Meeting of Shareholders, and then we will open the lines for Q&A.

今天上午，我們的執行長 Corey Fishman 和財務長 Judy Matthews 也來到了我們這裡。Corey 將致開幕詞，Judy 將在即將召開的 2025 年年度股東大會上提供有關我們的財務業績的詳細資訊以及財務相關提案的最新情況，然後我們將開始問答環節。

Before we begin, I would like to remind you that some of the information presented on this conference call will contain forward-looking statements concerning our plans, strategies, and prospects for our business.

在我們開始之前，我想提醒您，本次電話會議中提供的一些資訊將包含有關我們的業務計劃、策略和前景的前瞻性陳述。

These include the development, therapeutic, and market potential of ORLYNVAH, including the estimated annual prescriptions from targeted physicians; the sufficiency of our cash resources to fund our operating expenses into 2026; our ability to complete the commercial launch of ORLYNVAH in the US on or around August 20, 2025; our ability to expand into new territories and put additional resources in high prescribing geographies; and to expand the payer coverage of ORLYNVAH in the US; the sufficiency of our current stock of product in the US to satisfy our commercial requirements into the timelines expected; our ability to raise funds either through a capital raise and or revenue generated from sales of ORLYNVAH; the opportunity to engage in a business development transaction to sell, license, or otherwise dispose of our rights to sulopenem; and the protection provided by our patents.

這些包括 ORLYNVAH 的開發、治療和市場潛力，包括目標醫生的估計年度處方；我們的現金資源是否足以支付我們到 2026 年的營運費用；我們是否有能力在 2025 年 8 月 20 日左右在美國完成 ORLYNVAH 的商業發布；我們是否有能力擴展到新的地區並在高處方地區投入更多資源並在高處方在美國的付款人覆蓋範圍；我們目前在美國的產品庫存是否足以滿足我們在預期時間內的商業需求；我們是否有能力通過籌集資金和/或銷售 ORLYNVAH 產生的收入來籌集資金；是否有機會參與業務發展交易以出售、許可或以其他方式處置我們對舒利培南的權利；以及我們的專利提供的保護。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside of our control, including our ability to successfully prepare and implement commercialization plans for ORLYNVAH with EVERSANA; our ability to build and maintain a sales force and complete the commercial launch of ORLYNVAH on the timeline expected; the market opportunity for and the potential market acceptance of ORLYNVAH; the actions of third-party suppliers, manufacturers, and clinical research organizations; our ability to continue as a going concern; the accuracy of our expectations regarding how far into the future our cash on hand will fund our ongoing operations; and finally, all other factors discussed under the caption Risk Factors in our annual report on Form 10-Q as filed with the SEC this morning.

由於我們無法控制的各種因素，實際結果可能與這些前瞻性陳述所示的結果有重大差異，包括我們與 EVERSANA 成功制定和實施 ORLYNVAH 商業化計劃的能力；我們建立和維持銷售隊伍並按預期時間表完成 ORLYNVAH 商業發布的能力；ORLYNVAH的市場機會和潛在市場接受度；第三方供應商、製造商和臨床研究組織的行為；我們繼續經營的能力；我們對手頭現金在未來多長時間內為我們正在進行的運營提供資金的預期準確性；最後，今天上午向美國證券交易委員會提交的 10-Q 表年度報告中“風險因素”標題下討論的所有其他因素。

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 have provided reconciliation of GAAP reports 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。我們明確否認有更新此類聲明的義務。我們也會在電話會議中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 調整資訊的對帳。

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

說了這麼多，現在就交給你，科里，來做開場白。

Thanks, Kevin. Welcome, and thanks for joining us today. We have several exciting updates on our progress toward commercialization to discuss, and I'll do that in just a minute. First, I want to address a couple of items that continue to be raised by our investors so that the company's position is very clear.

謝謝，凱文。歡迎您，感謝您今天加入我們。我們在商業化方面取得了一些令人興奮的進展，我將在一分鐘內討論這些進展。首先，我想談談我們的投資人不斷提出的幾個問題，以便公司的立場非常明確。

As it relates to the company strategy, Iterum will be launching and commercializing ORLYNVAH in the US While a business development transaction remains a potential opportunity for Iterum at any point, including during the commercialization phase for ORLYNVAH, we believe that successfully launching ORLYNVAH into the uncomplicated urinary tract infection market in the US to help address the significant unmet need that exists for patients is critical and could also potentially build tremendous value in Iterum.

就公司策略而言，Iterum 將在美國推出和商業化 ORLYNVAH。雖然業務發展交易在任何時候對 Iterum 來說仍然是一個潛在機會，包括在 ORLYNVAH 商業化階段，但我們認為成功地將 ORLYNVAH 推向美國無複雜性尿路感染市場，以幫助解決患者存在的重大未滿足需求至關重要，並且還可能為 Iterum 創造巨大的價值。

Additionally, we have hired an outstanding Chief Commercial Officer, Christine Coyne, who has been and will continue to lead our launch and commercialization activities. Over her 30-year career in pharmaceuticals and biotech, Christine has worked across sales, marketing, market access, and operations and had P&L responsibility for numerous significant brands and launches spanning hospital and retail settings.

此外，我們還聘請了一位出色的首席商務官克里斯汀·科因 (Christine Coyne)，她一直並將繼續領導我們的發布和商業化活動。在製藥和生物技術領域 30 年的職業生涯中，Christine 曾從事銷售、行銷、市場准入和營運等工作，並負責醫院和零售環境中許多重要品牌和產品的損益。

Additionally, she has built comprehensive commercial plans and successfully launched antibiotics and antifungals into the market. She has been working seamlessly with our EVERSANA commercial team and has already proven to be a tremendous addition to the Iterum team.

此外，她還制定了全面的商業計劃，並成功將抗生素和抗真菌藥物推向市場。她一直與我們的 EVERSANA 商業團隊無縫合作，並已證明自己是 Iterum 團隊的重要補充。

Now I'd like to provide our investors with some very exciting updates regarding the commercialization of ORLYNVAH. We are very pleased to share with you that we expect to launch ORLYNVAH around August 20, a bit ahead of our previously announced timeline. Along with our commercialization partner, EVERSANA, we have been focused on launching as soon as possible in order to get this important product into the hands of physicians and their patients.

現在我想向我們的投資者提供有關 ORLYNVAH 商業化的一些非常令人興奮的最新消息。我們非常高興地與您分享，我們預計將於 8 月 20 日左右推出 ORLYNVAH，比我們之前宣布的時間表略早一些。我們與商業化合作夥伴 EVERSANA 一起致力於盡快推出這項重要產品，以便將這項重要產品交到醫生及其患者手中。

We believe we will be the first new branded product launched in the uncomplicated urinary tract infection space in over 25 years.

我們相信，我們將成為25年來第一個在簡單泌尿道感染領域推出的新品牌產品。

The uncomplicated urinary tract infection market in the US has a number of favorable factors that make it quite attractive commercially. The market itself is relatively large and based on our research generates approximately 40 million prescriptions annually in the US. Of those prescriptions, approximately two-thirds or about 26 million prescriptions are written for at-risk patients.

美國簡單尿路感染市場具有許多有利因素，使其具有相當的商業吸引力。市場本身相對較大，根據我們的研究，美國每年產生約 4000 萬張處方。在這些處方中，約有三分之二（約 2,600 萬張）是為高風險患者開立的。

At-risk patients are defined as women who are elderly; women with comorbidities like diabetes, heart failure, kidney failure, or cancer; or women with a history of recurrent infections. We believe these at-risk patients are ORLYNVAH's addressable market as they are likely the patients with limited or no other oral treatment options available and are the patients most in need of new therapies. There have been no new branded oral treatments launched in the uncomplicated urinary tract infection market in the US in over 25 years.

高風險患者定義為老年女性；患有糖尿病、心臟衰竭、腎衰竭或癌症等合併症的女性；或有反覆感染病史的女性。我們相信這些高風險患者是 ORLYNVAH 的目標市場，因為他們可能是可用的口服治療選擇有限或沒有其他口服治療選擇的患者，也是最需要新療法的患者。25 年來，美國簡單泌尿道感染市場尚未推出任何新的品牌口服治療藥物。

Additionally, it would appear from our antimicrobial resistance research that rising rates of resistance is eroding the efficacy of the existing older oral treatments.

此外，從我們的抗菌素抗藥性研究來看，抗藥性的上升正在削弱現有舊口腔治療的療效。

Lastly, almost all of the existing oral products have safety challenges that physicians need to consider when choosing which product to prescribe. These challenges range from existing products not being recommended for use in uncomplicated infections to products being contraindicated in patients with low creatinine clearance.

最後，幾乎所有現有的口服產品都存在安全性問題，醫生在選擇開立哪種產品時需要考慮這些問題。這些挑戰包括不建議將現有產品用於治療無併發症的感染，以及禁用於肌酸酐清除率低的患者。

With these current market dynamics as a backdrop, we believe it's easy to understand the significant need for new efficacious and safe treatment alternatives to effectively treat all patients, and particularly those at-risk patients that we just described.

以當前的市場動態為背景，我們相信很容易理解對新的有效且安全的治療替代方案的迫切需求，以便有效地治療所有患者，特別是我們剛才描述的那些高風險患者。

In the first phase of our launch, we plan to have sales resources in 20 targeted geographic territories. These territories were selected based on the estimated number of prescriptions written by high-value physicians, the rate of antibiotic resistance in that territory, and expected market access in that territory.

在我們推出的第一階段，我們計劃在 20 個目標地理區域擁有銷售資源。這些地區的選擇是基於高價值醫生開出的處方估計數量、該地區的抗生素抗藥性以及該地區的預期市場准入。

These territories are generally clustered around major metropolitan areas and are located in seven states: New York, New Jersey, Connecticut, Pennsylvania, Georgia, Florida, and Texas.

這些領土通常聚集在主要大都市區周圍，位於七個州：紐約州、新澤西州、康乃狄克州、賓夕法尼亞州、喬治亞州、佛羅裡達州和德克薩斯州。

Our sales team, as provided by EVERSANA, will cover around 2,300 physician targets who are all high-value prescribers. Of these physician targets, the majority are primary care physicians, followed by OBGYNs and urologists. In total, these target physicians are currently estimated to write between 1 million and 2 million prescriptions annually for uncomplicated urinary tract infection products.

我們的銷售團隊由 EVERSANA 提供，將涵蓋約 2,300 名醫生目標，他們都是高價值處方者。在這些醫生目標中，大多數是初級保健醫生，其次是婦產科醫生和泌尿科醫生。總體而言，目前估計這些目標醫生每年開立 100 萬至 200 萬張治療簡單泌尿道感染的處方。

Our market access and clinical teams have been out in the market working with payers and managed care organizations, helping them understand the clinical and economic value of ORLYNVAH. While still early, these payer discussions have resulted in interest in ORLYNVAH.

我們的市場准入和臨床團隊一直在市場上與付款人和管理式醫療組織合作，幫助他們了解 ORLYNVAH 的臨床和經濟價值。儘管還處於早期階段，但這些付款人討論已引起人們對 ORLYNVAH 的興趣。

We aim to continue these discussions by providing additional detailed information on the overall value ORLYNVAH can provide to the payers. Our ultimate goal is for patients to have access to ORLYNVAH in a majority of key plans.

我們旨在透過提供有關 ORLYNVAH 可以為付款人提供的整體價值的更多詳細資訊來繼續這些討論。我們的最終目標是讓患者在大多數關鍵計畫中都能使用 ORLYNVAH。

We have set our wholesaler acquisition cost, which represents our gross price before discounts, within the range established by other oral antibiotic launches for products that are used in other infection types. The range of this pricing is between $1,400 and $4,700 per course of treatment.

我們已將批發商採購成本（代表折扣前的總價）設定在其他口服抗生素針對用於治療其他感染類型的產品所確定的範圍內。每個療程的定價範圍在 1,400 美元至 4,700 美元之間。

And importantly, at these gross prices, these products enjoy very good market access. Very importantly, along working on payer coverage of ORLYNVAH and access to the product for patients, interim plans to help defray out-of-pocket expenses where possible for appropriate patients.

而且重要的是，以這樣的總價，這些產品享有非常好的市場准入。非常重要的是，除了致力於 ORLYNVAH 的付款人覆蓋和患者獲得產品的機會外，還制定了臨時計劃，盡可能幫助合適的患者分擔自付費用。

As we progress through the first phase of our launch over the coming months, we will continue to refine and optimize our physician targeting and resourcing in our key geographies. If this initial launch is successful, we will aim to expand our commercial resources in the field in order to increase revenue generation. This expansion could include adding additional high value geographies, as well as potentially adding more high value physician targets to our call plans in existing territories.

隨著我們在未來幾個月內推進第一階段的啟動，我們將繼續完善和優化我們在主要地區的醫生定位和資源配置。如果此次首次發布成功，我們將致力於擴大該領域的商業資源，以增加收入。這種擴展可能包括增加額外的高價值地理位置，以及可能在現有地區的呼叫計劃中增加更多高價值醫生目標。

As we think about acute therapies like ORLYNVAH in the treatment of uncomplicated urinary tract infections, speed to therapy, which is the time it takes for a patient to receive ORLYNVAH once a physician has written a prescription, is very important. These women are, in many cases, seeing their physician because they are dealing with the discomfort stemming from the symptoms of an uncomplicated urinary tract infection.

當我們考慮使用 ORLYNVAH 等急性療法治療無併發症的泌尿道感染時，治療速度（即醫生開出處方後患者接受 ORLYNVAH 治療所需的時間）非常重要。在許多情況下，這些女性去看醫生是因為她們正在處理無併發症的泌尿道感染症狀所引起的不適。

Our goal is to get ORLYNVAH to the patient as soon as possible. We have selected a specialty pharmacy that should help us optimize speed to therapy by leveraging both their technology that assists in clearing any potential requirements for managed care companies, such as prior authorizations, as well as the specialty pharmacy's delivery capabilities, which include pickup at a local pharmacy, courier services, and overnight shipments.

我們的目標是盡快將 ORLYNVAH 送到患者手中。我們選擇了專科藥房，該藥房可以利用其技術幫助我們優化治療速度，該技術可以幫助清除管理式醫療公司的任何潛在要求（例如事先授權），以及專科藥房的配送能力（包括在當地藥房取藥、快遞服務和隔夜發貨）。

Now I'd like to spend a moment and speak about manufacturing and supply of ORLYNVAH. As you may have seen yesterday, we have executed a commercial supply agreement with our finished product supplier, ACS Dobfar, located in Italy. This agreement also covers supply of sulopenem etzadroxil bulk drug substance.

現在我想花點時間談談 ORLYNVAH 的製造和供應。正如您昨天可能看到的，我們已經與位於義大利的成品供應商 ACS Dobfar 簽訂了商業供應協議。該協議還涵蓋舒洛培南乙羥氨芐散裝藥物的供應。

ACS Dobfar is a leading manufacturer of IV penem products globally, and a number of years ago, we commissioned the construction of a separate tabulating suite at one of their facilities to provide ORLYNVAH. We have had a long and extremely productive partnership with ACS Dobfar over the last decade and look forward to continuing that relationship well into the future.

ACS Dobfar 是全球領先的 IV 培南產品製造商，幾年前，我們委託在其工廠建造一個單獨的製錶套件，以提供 ORLYNVAH。在過去的十年中，我們與 ACS Dobfar 建立了長期且富有成效的合作關係，並期待在未來繼續保持這種合作關係。

The execution of this supply agreement is an essential element of our commercialization strategy, as we now have a world-class FDA-approved manufacturer contracted to make our active pharmaceutical ingredient and our commercial product on an ongoing basis, subject to the terms of the agreement.

該供應協議的執行是我們商業化策略的重要組成部分，因為我們現在擁有一家世界級的 FDA 批准的製造商，該製造商根據協議條款簽訂了合同，將持續生產我們的活性藥物成分和商業產品。

As a reminder, we have excellent expiration dating of ORLYNVAH, with a shelf life of six years from the date of manufacture. This provides an advantage with distributors in the market, as many other competitors and any new potential market entrants will likely have a shorter expiration time frame.

提醒一下，ORLYNVAH 的有效期限非常長，自生產日起保存期限為六年。這為市場上的分銷商提供了優勢，因為許多其他競爭對手和任何新的潛在市場進入者可能會有更短的到期時間。

We have successfully shipped our finished product to the US, it has cleared inspection and customs and is ready to ship to our specialty pharmacy. We expect that the quantity of product we already have available in the US will satisfy our commercial requirements into mid to late 2026.

我們已成功將成品運往美國，已通過檢驗和海關審核，準備運送至我們的專科藥房。我們預計，我們在美國現有的產品數量將滿足我們到 2026 年中後期的商業需求。

Another important item that we have previously disclosed was the extension of our $20 million regulatory payment owed to Pfizer. The due date of this payment was initially October of 2026, after Iterum exercised its deferral option, and this payment is now due in October of 2029.

我們先前揭露的另一項重要事項是延長我們欠輝瑞公司的 2,000 萬美元監管付款。在 Iterum 行使延期選擇權後，這筆款項的到期日最初為 2026 年 10 月，現在該付款的到期日為 2029 年 10 月。

This has removed a near-term financial obligation from next year and allows a greater portion of any revenue generated by ORLYNVAH, or any additional capital raised, to be used to continue to fund the commercialization of ORLYNVAH.

這免除了明年的短期財務義務，並允許 ORLYNVAH 產生的任何收入或任何額外籌集的資金的更大一部分用於繼續資助 ORLYNVAH 的商業化。

On the intellectual property front, we have two types of protection for ORLYNVAH: market exclusivity and patents. On the market exclusivity front, the FDA has designated ORLYNVAH as a qualified infectious disease product for uncomplicated urinary tract infections, and a number of other indications.

在智慧財產權方面，我們對 ORLYNVAH 有兩種保護：市場獨佔權和專利。在市場獨佔權方面，FDA 已指定 ORLYNVAH 為用於治療無併發症泌尿道感染以及其他多種適應症的合格傳染病產品。

In October 2024, upon approval of ORLYNVAH, the FDA confirmed an additional five years of market exclusivity under the GAIN Act, resulting in a total of 10 years of market exclusivity in the US from the date of approval. Therefore, the market exclusivity that FDA has granted ORLYNVAH will expire in October of 2034.

2024年10月，ORLYNVAH獲得批准後，FDA根據GAIN法案確認了額外五年的市場獨佔權，因此從批准之日起，ORLYNVAH在美國的市場獨佔權總計為10年。因此，FDA授予ORLYNVAH的市場獨佔權將於2034年10月到期。

On the patent front for ORLYNVAH, we exclusively license from Pfizer one US patent and three foreign patents. Additionally, we own four US patents, one Japanese patent, one Korean patent, two Australian patents, and now one Canadian patent, which we were pleased to have been granted by the Canadian Patent Office in July.

在 ORLYNVAH 的專利方面，我們從輝瑞公司獨家獲得了一項美國專利和三項外國專利的授權。此外，我們還擁有四項美國專利、一項日本專利、一項韓國專利、兩項澳洲專利，現在還有一項加拿大專利，我們很高興這項專利於 7 月獲得了加拿大專利局的批准。

The patents owned by us are scheduled to expire between 2039 and 2041, excluding any additional term for patent adjustments or patent term extensions. We also own three pending US patent applications and 25 pending foreign patent applications, which collectively cover uses of sulopenem and probenecid and bilayer tablets of sulopenem etzadroxil and probenecid.

我們擁有的專利預計將於 2039 年至 2041 年之間到期，不包括任何專利調整或專利期限延長的額外期限。我們還擁有三項正在申請的美國專利申請和 25 項正在申請的外國專利申請，這些專利申請共同涵蓋了舒利培南和丙磺舒的用途以及舒利培南依曲羥酯和丙磺舒的雙層片劑。

With the combination of marketing exclusivity and patent protection, we believe ORLYNVAH will have a very long runway to create value.

我們相信，透過結合市場獨佔權和專利保護，ORLYNVAH 將擁有很長的創造價值的道路。

In summary, we are extremely excited to be launching ORLYNVAH in the next few weeks and are looking forward to bringing this important new treatment option to physicians and their patients.

總之，我們非常高興能夠在接下來的幾週內推出 ORLYNVAH，並期待為醫生及其患者帶來這項重要的新治療選擇。

Now I'll turn the call over to Judy Matthews for a financial update.

現在我將把電話轉給朱迪·馬修斯 (Judy Matthews) 來報告財務最新情況。

Thanks, Corey.

謝謝，科里。

Total operating expenses were $5.5 million in the second quarter of 2025, compared to $4 million in the second quarter of 2024. Operating expenses include cost of sales, which is primarily the amortization of an intangible asset, research, and development expenses, and general and administrative expenses.

2025 年第二季總營運費用為 550 萬美元，而 2024 年第二季為 400 萬美元。營業費用包括銷售成本（主要是無形資產攤提）、研究與開發費用、一般及管理費用。

R&D costs were $1 million for the second quarter, compared to $2.1 million for the same period in 2024. The primary driver of the decrease in R&D expense for the second quarter was the decrease in costs associated with the REASSURE trial.

第二季的研發成本為 100 萬美元，而 2024 年同期為 210 萬美元。第二季研發費用下降的主要原因是與 REASSURE 試驗相關的成本下降。

G&A costs were $4.2 million for the second quarter, compared to G&A costs of $1.9 million for the same period in 2024. The primary driver of the increase in G&A expense for the second quarter was pre-commercialization activities.

第二季的 G&A 成本為 420 萬美元，而 2024 年同期的 G&A 成本為 190 萬美元。第二季一般及行政費用增加的主要驅動因素是商業化前活動。

Our net loss on a US GAAP basis was $6.5 million for the second quarter of 2025, compared to a net loss of $5 million for the second quarter of 2024.

根據美國 GAAP 計算，2025 年第二季我們的淨虧損為 650 萬美元，而 2024 年第二季的淨虧損為 500 萬美元。

On a non-GAAP basis, which excludes certain non-cash adjustments, our net loss of $5.1 million in the second quarter of 2025, compared to our non-GAAP net loss of $3.8 million in the second quarter of 2024. The $1.3 million increase in our non-GAAP net loss for the second quarter was primarily a result of higher G&A due to spending on pre-commercialization activities.

以非公認會計準則計算（不包括某些非現金調整），我們 2025 年第二季的淨虧損為 510 萬美元，而 2024 年第二季的非公認會計準則淨虧損為 380 萬美元。我們第二季非公認會計準則淨虧損增加 130 萬美元，主要是由於商業化前活動支出導致的一般及行政費用增加。

At the end of June, we had cash and equivalents of $13 million. Based on our current operating plan, which includes our expected launch, commercial launch later this month, we expect that our cash and cash equivalents, together with $2.2 million of net proceeds raised under our at-the-market offering program from July 1 through August 1, 2025, will be sufficient to fund our operations into 2026.

截至六月底，我們的現金及等價物為1300萬美元。根據我們目前的營運計畫（包括我們預計在本月稍後推出的商業發布），我們預計我們的現金和現金等價物，加上 2025 年 7 月 1 日至 8 月 1 日期間透過市場發行計畫籌集的 220 萬美元淨收益，將足以資助我們到 2026 年的營運。

As of August 4, 2025, we had approximately 44.7 million ordinary shares outstanding.

截至 2025 年 8 月 4 日，我們已發行約 4,470 萬股普通股。

On September 10, we are holding our Annual General Meeting of Shareholders, and many of you will have noted from our proxy statement in the voting ballots that have gone out, that we have requested authorization of an additional 80 million shares, which is a 100% increase to the existing authorized share capital of the company.

9 月 10 日，我們將召開年度股東大會，你們中的許多人可能已經從已經發出的投票選票的代理聲明中註意到，我們已請求授權額外發行 8000 萬股股票，這將使公司現有授權股本增加 100%。

Based on proxy proposals to increase the authorized share capital of 41 peer companies during 2024, 2025, an addition of this size is in line with our peers. The purpose of this proposal is a matter of good housekeeping to ensure we have the financial flexibility to fund the strategic objectives of the business, including the upcoming commercial launch, until such time as we might reach cash flow break-even. As always, we will exercise care when issuing shares.

根據 2024 年、2025 年期間增加 41 家同業公司授權股本的代理提案，這一規模的增加與我們的同業一致。該提案的目的是為了做好管理，確保我們擁有財務靈活性，為業務的策略目標（包括即將進行的商業發布）提供資金，直到我們達到現金流量收支平衡。像往常一樣，我們在發行股票時會謹慎行事。

Additionally, as an Irish company, we are seeking a waiver of preemption rights on those potentially newly authorized shares. Without this waiver, we are limited in the types of financing we can execute. The financings available to us without having a waiver of preemption rights in place are more costly and more dilutive to you, our shareholders. So we ask that you please vote in favor of these proposals at the upcoming Annual General Meeting.

此外，作為一家愛爾蘭公司，我們正在尋求放棄對這些可能新授權股份的優先購買權。如果沒有這項豁免，我們可以執行的融資類型將受到限制。如果不放棄優先購買權，我們獲得的融資對我們的股東來說成本更高，稀釋性更強。因此，我們請求您在即將召開的年度股東大會上投票贊成這些提議。

Now I will turn it over for questions.

現在我將把這張桌子交給大家提問。

Thank you. (Operator Instructions)

謝謝。（操作員指示）

There are no questions registered at this moment. So I would like to turn the call back over to Mr. Fishman for closing remarks.

目前還沒有登記任何問題。因此，我想將電話轉回給菲什曼先生，請他作最後發言。

Thank you, Megan.

謝謝你，梅根。

In closing, we have made tremendous progress and are very excited for our upcoming launch. Over the last few months, as our plan to launch has been communicated, we have received numerous inquiries about ORLYNVAH and the timing of its availability.

最後，我們已經取得了巨大的進展，並對即將推出的產品感到非常興奮。在過去的幾個月裡，隨著我們的啟動計劃的公佈，我們收到了許多關於 ORLYNVAH 及其上市時間的詢問。

Along with our commercialization partner, EVERSANA, we believe there is a significant need for ORLYNVAH in the US uncomplicated urinary tract infection market and we're looking forawrd to providing the first and only oral penem in the US to physicians and new patients.

我們與商業化合作夥伴 EVERSANA 一起相信，美國簡單尿路感染市場對 ORLYNVAH 有著巨大的需求，我們期待為醫生和新患者提供美國首個也是唯一一個口服培南。

We appreciate our investors' continued support as Iterum enters this new phase in its evolution into a commercial entity. Thanks for joining us today and have a great day.

我們感謝投資者在 Iterum 向商業實體發展的新階段給予的持續支持。感謝您今天加入我們並祝您度過愉快的一天。

This concludes today's conference call. Thank you for your participation and enjoy the rest of your day.

今天的電話會議到此結束。感謝您的參與並祝您今天過得愉快。