Acurx Pharmaceuticals Inc (ACXP) 2025 Q2 法說會逐字稿

Greetings and welcome to the Acurx Pharmaceuticals to discuss second quarter 2025 financial results conference call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce Robert Shawah, Chief Financial Officer.

您好，歡迎參加 Acurx Pharmaceuticals 討論 2025 年第二季財務業績電話會議。（操作員指示）提醒一下，本次會議正在錄音。現在我很高興介紹財務長羅伯特·沙瓦 (Robert Shawah)。

Please go ahead.

請繼續。

Thank you, Stacey. Good morning and welcome to our call. This morning, we issued a press release providing financial results, and company highlights for the second quarter of 2025, which is available on our website at Acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter and the June 30, and then turn the call back over to Dave for his closing remarks.

謝謝你，史黛西。早安，歡迎來電。今天上午，我們發布了一份新聞稿，其中介紹了2025年第二季度的財務業績和公司亮點，您可以在我們的網站Acurxpharma.com上查閱。今天，Acurx總裁兼執行長Dave Luci將與我一同分享公司最新動態與展望。接下來，我將提供第二季和 6 月 30 日的一些財務亮點，然後將電話轉回給戴夫進行總結發言。

As a reminder, during today's call, we'll be making certain forward-looking statements. Which are based on current information, assumptions, estimates, and projections about future events. That are all subject to change and involve a number of risks and uncertainties, that may cause actual results to differ materially from those contained in the forward-looking statements.

提醒一下，在今天的電話會議中，我們將做出一些前瞻性的陳述。這些都是基於當前資訊、假設、估計和對未來事件的預測。所有這些都可能發生變化，並涉及許多風險和不確定性，可能導致實際結果與前瞻性陳述中的結果有重大差異。

Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission. Including our quarterly report on Form 10-Q, which we filed yesterday, Monday, August 11, 2025. You are cautioned not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time in the future. This conference call contains time sensitive information that's accurate only as of the date of this live broadcast today, August 12, 2025.

投資者應考慮這些風險以及我們向美國證券交易委員會提交的文件中所述的其他資訊。包括我們昨天（2025 年 8 月 11 日星期一）提交的 10-Q 表格季度報告。請注意不要過度依賴這些前瞻性陳述，Acurx 不承擔在未來任何時間更新此類陳述的義務。本次電話會議包含時間敏感訊息，僅截至今天（2025 年 8 月 12 日）現場直播之日準確。

I'll now turn the call over to Dave. Dave?

我現在將電話轉給戴夫。戴夫？

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter of '25 and also to hear some recent updates. Then we'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the second quarter or in some cases shortly thereafter.

謝謝，羅布。大家早安，非常感謝大家加入我們，回顧 2025 年第二季的財務表現並聽取一些最新進展。那麼我們很樂意回答任何問題。首先，我想簡要地總結一下我們第二季或之後不久的一些主要活動。

In April, we announced that the Indian Patent Office granted a new patent for our DNA polymerase 3C inhibitors, which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing pre-clinical antibiotic development program of ACX-375C, which targets the treatment of infections caused by MRSA, VRE, DRSP and Anthrax.

今年 4 月，我們宣布印度專利局授予我們的 DNA 聚合酶 3C 抑制劑一項新專利，該專利將於 2039 年 12 月到期，但可延長。這為我們正在進行的 ACX-375C 臨床前抗生素開發計劃構成了另一個重要基石，該計劃旨在治療 MRSA、VRE、DRSP 和炭疽病引起的感染。

In May, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding. In June, the company entered into a warrant inducement agreement with an existing warrant holder for the exercise of warrants to purchase an aggregate of 222,272 shares of the company's common stock, having a current exercise price for the series A warrants to purchase 61,538 shares of the company's common stock at $65 per share.

5 月份，我們與林肯公園資本 (Lincoln Park Capital) 達成股權信用額度，獲得高達 1,200 萬美元的額外融資。6 月份，該公司與現有認股權證持有人達成認股權證誘導協議，行使認股權證可購買總計 222,272 股公司普通股，A 系列認股權證的當前行使價格為每股 65 美元，可購買 61,538 股公司普通股。

For series B warrants to purchase 27,400 shares of our common stock at $65 per share. And for series C warrants to purchase 66,667 shares of our common stock at $65.20 per share. And series D warrants to purchase 66,667 shares of our common stock at an exercise price of $65.20 per share. Originally issued in July 22 in May '23 at a reduced exercise price of $12 per share.

B 系列認股權證可以每股 65 美元的價格購買 27,400 股普通股。C 系列認股權證可以每股 65.20 美元的價格購買 66,667 股普通股。D 系列認股權證以每股 65.20 美元的行使價購買 66,667 股普通股。最初於 23 年 5 月以每股 12 美元的降低行使價發行。

In consideration for the company's agreement to issue new series G1 warrants to purchase up to an aggregate of 311,180 shares of common stock with a five year term and new series G warrants to purchase up to an aggregate 133,363 shares of our common stock with a five year term, from shareholder approval, each at an exercise price of $8.50 per share.

考慮到公司同意發行新的 G1 系列認股權證，以五年期限購買最多 311,180 股普通股，以及新的 G 系列認股權證，以五年期限購買最多 133,363 股普通股，自股東批准之日起，每份認股權證的行使價為每股 8.50 美元。

The gross proceeds to the company from the exercise of the existing warrants was approximately $2.7 million with net proceeds of $2.5 million, after deducting fees and expenses payable by the company. The warrant inducement transaction closed on June 20. The company will continue its multi-step approach to raising capital through customary financings, warrant inducements, and public-private partnership opportunities going forward.

扣除公司應付的費用和開支後，行使現有認股權證為公司帶來的總收益約為 270 萬美元，淨收益為 250 萬美元。認股權證誘導交易於 6 月 20 日完成。該公司將繼續透過常規融資、認股權證誘導和公私合作機會等多步驟方式籌集資金。

In June, we announced the publication of our phase to the clinical trial data for our ibezapolstat and C. Difficile infection in Lancet Microbe, the world leading microbiology research journal. This publication is available on our website at acurxpharma.com. The Lancet Microbe summary highlighted ibezapolstat, phase 2 results as follows, and I quote, results included high rates of clinical cure and ibezapolstat treated subjects with no recurrence. Furthermore, ibezapolstat that was found to be safe, well tolerated, and associated with the preservation of key health promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent CDI. End quote.

6 月，我們宣佈在世界領先的微生物學研究期刊《柳葉刀微生物》上發表了 ibezapolstat 和艱難梭菌感染的臨床試驗數據。本出版品可在我們的網站 acurxpharma.com 上查閱。 《柳葉刀微生物學》摘要重點介紹了伊貝扎泊司他的 II 期臨床試驗結果，如下（本人引用）：結果顯示，伊貝扎泊司他治療的受試者臨床治癒率高，且無復發。此外，研究發現，伊貝札泊司他安全、耐受性良好，並且與維持負責膽汁酸穩態的關鍵健康促進細菌有關，而膽汁酸穩態是預防復發性 CDI 的關鍵成分。引言結束。

The Lancet publication also highlighted ibezapolstat's potential as a novel antibiotic treatment for CDI with high rates of clinical cure and sustained clinical cure, while preserving and restoring the healthy gut microbiota. The Senior Author, Professor Kevin Gary, PhD, University of Houston, and a Co-Author of the IDSA, Infectious Disease Society of America treatment guidelines for C. difficile infection, noted that current US and European treatment guidelines for CDI recommend only two antibiotics for treatment, oral vancomycin or [Fidaxomicin].

《柳葉刀》雜誌也強調了伊貝札泊司他作為一種新型抗生素治療 CDI 的潛力，具有很高的臨床治癒率和持續的臨床治癒率，同時還能維持和恢復健康的腸道菌叢。資深作者、休士頓大學 Kevin Gary 教授、美國傳染病學會艱難梭菌感染治療指南的合著者指出，目前美國和歐洲的艱難梭菌感染治療指南僅建議兩種抗生素進行治療，即口服萬古黴素或[非達黴素]。

Vancomycin is most commonly used, but has a low clinical cure rate of 70% to 92% and a sustained clinical cure rate of 42% to 71%. Fidaxomicin has fewer recurrences, but low rates of clinical cure at about 84%, and sustained clinical cure at 67%.

萬古黴素最常使用，但臨床治癒率較低，為70%～92%，持續臨床治癒率為42%～71%。非達黴素復發率較低，但臨床治癒率較低，約84%，持續臨床治癒率僅67%。

Professor Gary further noted that both marketed antibiotics for CDI are associated with emerging antimicrobial resistance, stating, and I quote, the clinical need for a new antibiotic like ibezapolstat to treat CDI is underscored by a recently published study in clinical infectious diseases by [Dr. Curtis Dansky] of the Cleveland [VA], and conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced Fidaxomicin susceptibility, may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding, end quote. Again, that's by Dr. Gary.

加里教授進一步指出，兩種用於治療 CDI 的市售抗生素都與新出現的抗菌素抗藥性有關，並指出（我引用他的原話），臨床上需要一種像伊貝扎泊司他這樣的新型抗生素來治療 CDI，這一點得到了克利夫蘭 [VA]的柯蒂斯·丹斯基博士最近發表的一項臨床傳染病研究的強調，該研究是在醫院環境中進行的，記錄了臨床上對非達黴素敏感性降低的艱難梭菌分離株可能會在治療期間出現並傳播給其他患者。醫學界應該意識到這一令人震驚的發現，引文結束。再次強調，這是加里博士說的。

Also in June, we announced results from our collaboration with Leiden University Medical Center of its study of the mechanism of action of our l polymerase IIIC platform of inhibitors with data presented at the Federation of American Societies for experimental biology scientific conference to meet in the in the Netherlands on May 21.

同樣在 6 月份，我們公佈了與萊頓大學醫學中心合作研究 l 聚合酶 IIIC 抑制劑平台作用機制的成果，相關數據將於 5 月 21 日在荷蘭舉行的美國實驗生物學學會聯合會科學會議上發表。

A scientific presentation was provided by Mia Urem, PhD from Leiden University Medical Center, entitled A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase PolC of Gram-Positive Priority Pathogens. This scientific conference is the premier venue for the newest research and technological trends in molecular machines in the human body, that ensure DNA replication and expression of genes to create proteins that make up the cell.

萊頓大學醫學中心的 Mia Urem 博士進行了一場科學報告，題為「獨特的抑制劑構象選擇性地針對革蘭氏陽性優先病原體的 DNA 聚合酶 PolC」。這次科學會議是人體分子機器最新研究和技術趨勢的首要場所，這些機器確保 DNA 複製和基因表達，產生構成細胞的蛋白質。

In August, we implemented a 1 for 20 reverse stock split in an effort to comply with Nasdaq Listing Maintenance requirements. We continue to identify and pursue funding opportunities for our phase 3 clinical trial program for ibezapolstat, and consider alternative financial pathways to achieve success. We have several initiatives underway to this end, and we'll report in future updates as appropriate.

8 月份，我們實施了 1:20 的反向股票分割，以符合納斯達克上市維護要求。我們將繼續為伊貝札波爾司他的 3 期臨床試驗計畫尋找和尋求融資機會，並考慮其他財務途徑以取得成功。為此，我們正在採取多項舉措，並將在未來的更新中酌情報告。

As we've continually reported, it doesn't suppose that clinical results continue to demonstrate its leadership in the field in a serious and potentially life-threatening infectious disease called C. difficile bacteria, that the US CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. ibezapolstat has FDA QIDP, and fast track desiG&Ations for the treatment of CDI.

正如我們不斷報道的那樣，臨床結果並不能繼續證明其在治療一種名為艱難梭菌的嚴重且可能危及生命的傳染病領域的領導地位，美國疾病控制與預防中心將其歸類為緊急威脅，並呼籲使用新型抗生素進行初始治療，且復發率較低。 ibezapolstat 擁有 FDA QIDP 和用於治療 CDI 的快速通道設計和許可。

We also believe that ibezapolstat if approved, could make a favorable economic impact by reducing the overall annual US cost burden for C. difficile infection of approximately $5 billion a year, of which $2.8 billion is due to a recurrent infection, what we call the secondary market. With our continuing momentum and passion to achieve success for our stakeholders, we remain confident that while development by threatening infectious disease called C. difficile bacteria, that the US CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment, that also have a low incidence of recurrence ibezapolstat's competitive profile continues to strengthen, the best is yet to come as we navigate through these very challenging times in the macroeconomic environment and in our industry sector.

我們也相信，如果伊貝札波爾司他獲得批准，可以產生良好的經濟影響，減少美國每年因艱難梭菌感染而產生的總成本負擔約 50 億美元，其中 28 億美元是由於復發性感染造成的，我們稱之為二級市場。憑藉我們為利益相關者取得成功的持續動力和熱情，我們仍然相信，儘管威脅性傳染病艱難梭菌的發展，美國疾病控制與預防中心將其歸類為緊急威脅，並呼籲開髮用於初始治療的新型抗生素，且複發率較低，但伊貝扎泊司他的競爭力仍在不斷增強，在我們度過宏觀經濟和環境和行業領域的這些極具挑戰性的時期還在後，在未來。

And now back to our CFO, Rob Shawah to guide you through the highlights of our financial results for the second quarter of '25. Rob?

現在回到我們的財務長 Rob Shawah，他將向您介紹我們 25 年第二季財務業績的亮點。搶？

Thanks, Dave. Our financial results for the second quarter ended June 30, 2025 were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.1 million compared to $3.7 million as of December 31, 2024. During the second quarter, the company raised a total of approximately $3.4 million of gross proceeds, through purchases under the equity line of credit and a war inducing agreement.

謝謝，戴夫。我們截至 2025 年 6 月 30 日的第二季財務業績已包含在今天早上發布的新聞稿中。該公司本季末的現金總額為 610 萬美元，而截至 2024 年 12 月 31 日的現金總額為 370 萬美元。第二季度，該公司透過股權信用額度和戰爭誘因協議下的購買，共籌集了約 340 萬美元的總收益。

Research and development expenses for the three months ended June 30 were $0.5 million compared to $1.8 million for the three months ended June 30, 2024, a decrease of $1.3 million. The decrease was due primarily to a decrease in manufacturing costs of $0.3 million and a decrease in consulting costs of $1 million as a result of the prior year trial related expenses. For the six months ended June 30, 2025, research and development expenses were $1.1 million versus $3.4 million for the six months ended June 30, 2024.

截至 2024 年 6 月 30 日的三個月的研發費用為 50 萬美元，而截至 2024 年 6 月 30 日的三個月的研發費用為 180 萬美元，減少了 130 萬美元。減少的主要原因是製造成本減少了 30 萬美元，並且由於上一年試驗相關費用導致諮詢成本減少了 100 萬美元。截至 2025 年 6 月 30 日的六個月，研發費用為 110 萬美元，而截至 2024 年 6 月 30 日的六個月為 340 萬美元。

The decrease of $2.3 million was primarily due to a reduction of $0.6 million in manufacturing costs and a $1.7 million decrease in consulting costs, due to higher trial-related costs in the prior year. General and administrative expenses for the three months ended June 30, 2025 were $1.7 million compared to $2.3 million for the three months ended June 30, 2024, a decrease of $0.6 million.

減少 230 萬美元主要是由於製造成本減少 60 萬美元以及諮詢成本減少 170 萬美元，因為上一年試驗相關成本較高。截至 2025 年 6 月 30 日的三個月的一般及行政費用為 170 萬美元，而截至 2024 年 6 月 30 日的三個月的一般及行政費用為 230 萬美元，減少了 60 萬美元。

The decrease was primarily due to a $0.7 million decrease in share-based compensation. Offset by a $0.1 million increase in professional fees. For the six months end of June 30, 2025, general and administrative expenses were $3.3 million versus $5.1 million for the six months end of June 30, 2024.

下降的主要原因是股權激勵費用減少了 70 萬美元。抵銷了專業費用增加 10 萬美元的影響。截至 2025 年 6 月 30 日的六個月，一般及行政開支為 330 萬美元，而截至 2024 年 6 月 30 日的六個月為 510 萬美元。

A decrease of $1.8 million. The decrease was due primarily to a $0.6 million decrease in professional fees. And a $1.2 million decrease in share-based compensation. The company reported a net loss of $2.2 million or $1.89 per diluted share for the three months ended June 30, 2025. Compared to a net loss of $4.1 million or $5.21 per diluted share for the three months end of June 30, 2024.

減少了180萬美元。減少的主要原因是專業費用減少了 60 萬美元。股權激勵費用減少了 120 萬美元。該公司報告稱，截至 2025 年 6 月 30 日的三個月淨虧損為 220 萬美元，即每股 1.89 美元。相較之下，截至 2024 年 6 月 30 日的三個月淨虧損為 410 萬美元，即每股攤薄虧損 5.21 美元。

And a net loss of $4.4 million or $4.01 per diluted share for the six months ended June 30, 2025. Compared to a net loss of $8.5 million or $10.84 per diluted share for the six months end of June 30, 2024. All for the reasons previously mentioned. The company had a reverse split adjusted 1,470,352 shares outstanding as of June 30, 2025.

截至 2025 年 6 月 30 日的六個月淨虧損為 440 萬美元，即每股虧損 4.01 美元。相較之下，截至 2024 年 6 月 30 日的六個月淨虧損為 850 萬美元，即每股攤薄虧損 10.84 美元。所有這些都是出於前面提到的原因。截至 2025 年 6 月 30 日，該公司已發行 1,470,352 股反向分割調整股票。

With that, I'll turn the call back over to Dave.

說完這些，我就把電話轉回給戴夫。

Thanks, Rob, and to all of you for joining us today. And now back to our operator Stacey to open the call for questions. Stacey.

謝謝羅布，也謝謝大家今天的到來。現在回到我們的接線生 Stacey 來開始提問環節。史黛西。

(Operator Instructions) James Molloy, Alliance Global Partners.

（操作員指示） James Molloy，Alliance Global Partners。

Good morning. Thank you for taking, my questions. Just to give you a quick call. Looking at the OpEx coming down, in line, something with the cash preservation, high priority, this is a trend we should expect to continue through, the rest '25 and '26, and then maybe following up on that. I know it's a bit up in the air and a little out of your hands, but, as an outsider looking in, when should we anticipate potentially? Either a partnership or -- either a partnership to be signed. That's something that '25, you got [2024, '25], 2026, and then, getting these trials up and running for ibeza. Thank you.

早安.感謝您回答我的問題。只是想快速打個電話給你。從營運支出下降來看，這與現金保全是高度優先的，我們預計這一趨勢將持續到 2025 年和 2026 年剩餘時間，然後可能會繼續保持。我知道這有點懸而未決，有點超出你的掌控範圍，但是，作為一個局外人，我們應該何時預測潛在情況？要嘛是合作關係，要嘛是要簽署的合作夥伴關係。這是'25，你得到了[2024，'25]，2026，然後，為 ibeza 啟動和運行這些試驗。謝謝。

Sure, Jim. I'll start with your second question. I, I'll ask you to repeat the first, but, for your second question, it could be, any time here in the second half in terms of a private partnership, if we're able to announce something like that. In terms of -- I use the word partnership, broadly to include, government agencies, because that's their preference. They like to say that, they're not providing grants, they're entering into partnerships, and they expect their incubator companies to be good partners.

當然，吉姆。我先回答你的第二個問題。我，我請你重複第一個問題，但是，對於你的第二個問題，就私人合作夥伴關係而言，這可能是在下半年的任何時候，如果我們能夠宣布這樣的事情的話。就——我使用合作夥伴關係這個詞，廣義上包括政府機構，因為這是他們的偏好。他們喜歡說，他們不是在提供補助金，而是在建立合作關係，並且他們希望他們的孵化器公司成為好的合作夥伴。

So that process is ongoing and will certainly slip into 2026, given the dynamics that are going on in Washington. So the federal government's year-end is September 30, and as I understand it through the folks we work with in Washington, they're expecting a continuing resolution. Toward the end of the year, kind of the usual annual punt to kind of calendar year ends as being likely the time when funding for the new fiscal year, gets appropriated, through the -- starting with the [House Ways and Means Committee]. So those are all going very well, I would say, and we're confident that, we will have success in these regards, but I think particularly with the government it's going to take time. But could I ask you to ask the first question again please.

因此，這一進程仍在繼續，考慮到華盛頓目前的動態，這一進程肯定會持續到 2026 年。因此，聯邦政府的年度結束日期是 9 月 30 日，據我從我們在華盛頓的同事那裡了解到，他們期待著持續的解決方案。每年年底，也就是通常的年度結束，很可能是新財政年度的資金撥付的時間，從…開始[眾議院籌款委員會]。所以我想說，這些都進展得很順利，我們有信心，我們將在這方面取得成功，但我認為，特別是對政府來說，這需要時間。但我能否請您再問第一個問題？

Yes, of course. So, and I see that you guys are -- preserving cash, operating expenses coming down, nicely in line with your expectation to preserve capital. Is that something we should expect, a trend we should continue to second half '25 and it the '26?

是的當然。所以，我看到你們——保留現金，營運費用下降，這與你們保留資本的預期完全一致。這是我們該期待的嗎？這種趨勢應該持續到 2025 年下半年和 2026 年嗎？

Oh, absolutely. Yeah, we're trimming tremendously. What I would say is, when you're seeing things like G&A expenses that we report on these earnings calls, that's a different number than cash flow that includes cash and non-cash items. So our cash burn is -- it's down to close to $400,000 a month at this point. And we expect to continue that process.

哦，當然了。是的，我們正在大幅削減。我想說的是，當您看到我們在這些收益電話會議上報告的一般及行政費用等內容時，該數字與包括現金和非現金項目的現金流不同。因此我們的現金消耗——目前已降至每月近 40 萬美元。我們希望繼續這一進程。

Now, there is some clinical, strategy -- things that we will be announcing in the near future that we're currently considering for a new -- very small clinical trial that we can handle financially without a lot of heavy lift on our end, but we'll be able to come out with more information on that next quarter, after we get in front of our board of directors.

現在，有一些臨床、策略——我們將在不久的將來宣布一些事情，我們目前正在考慮進行一項新的——非常小的臨床試驗，我們可以在財務上處理，而不需要我們承擔太多的繁重工作，但在提交給董事會後，我們將能夠在下個季度公佈更多信息。

Excellent and as always excellent work on keeping the crews in line.

非常出色，一如既往地出色地完成了讓船員們保持一致的工作。

(Operator Instructions) Matthew Keller, H.C. Wainwright.

（操作員指示）Matthew Keller，H.C. Wainwright。

Yeah, hey, good morning, everyone, and congrats on the quarter. So just two quick ones from us. Obviously the publication of the two -- the 2b data was very nice. I was wondering if there were any additional feedback that you got from either physician community or [KOL] community on that publication. And then the second question I have for you is kind of related to maybe the previous questions, but are there any other rate limiting steps ahead of the upcoming phase 3, studies that we should be thinking about?

是的，嘿，大家早安，恭喜本季。我們只想簡單回答兩個問題。顯然，這兩個 2b 數據的發布非常好。我想知道您是否從醫生社區或[KOL]社區獲得了有關該出版物的任何其他反饋。然後我想問您的第二個問題可能與前面的問題有點相關，但是在即將到來的第三階段研究之前，是否還有其他我們應該考慮的限制速度的步驟？

Well, thank you, Matthew for the questions. For rate limiting steps, the only one, and it's not even really a long. Rate limit, would be the -- as we've talked about the [fill finish] of the ibezapolstat supply into the phase 3 trials. We've been reluctant to do fill finish, because once you do, then your drug is dated. And we want to forestall that -- to maximize the amount of time we have to use the ibezapolstat, without it becoming obsolete.

好吧，謝謝馬修提出的問題。對於速率限制步驟，只有一個，而且它甚至不是很長。速率限制，將是－正如我們在第三階段試驗中討論過的 ibezapolstat 供應的[填充完成]。我們一直不願意進行填充完成，因為一旦這樣做，您的藥物就過期了。我們希望預防這種情況發生——最大限度地延長伊貝扎波爾司他的使用時間，同時又不讓它變得過時。

So that may be a couple of month process. It, it's nothing significant. But everything else is literally ready. The European Medicines Agency and FDA amazingly agreed entirely on the identical same protocol for the two trials. So that's gone quite well.

所以可能需要幾個月的時間。這，這沒什麼大不了的。但其他一切都已準備就緒。令人驚訝的是，歐洲藥品管理局和 FDA 完全同意對這兩項試驗採用相同的方案。一切進展順利。

There are no further questions. This does conclude today's teleconference. Thank you for your participation. You may now disconnect your line.

沒有其他問題了。今天的電話會議到此結束。感謝您的參與。現在您可以斷開線路了。

Thank you, Stacey.

謝謝你，史黛西。