Acurx Pharmaceuticals Inc (ACXP) 2024 Q4 法說會逐字稿

Greetings, and welcome to the Acurx Pharmaceutical's fourth quarter and full year 2024 financial results and business update. (Operator Instructions) As a reminder, this conference is being recorded.

您好，歡迎關注 Acurx Pharmaceutical 2024 年第四季和全年財務業績和業務更新。（操作員指示）提醒一下，本次會議正在錄音。

I'll now turn the conference over to your host Mr. Rob Shawah, Chief Financial Officer for Acurx Pharmaceuticals. Please go ahead, sir.

現在，我將會議交給主持人、Acurx Pharmaceuticals 財務長 Rob Shawah 先生。先生，請繼續。

Thank you, Melissa. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the fourth quarter and full year of 2024, which is available on our website at acurxpharma.com.

謝謝你，梅麗莎。早安，歡迎來電。今天上午，我們發布了一份新聞稿，提供了 2024 年第四季度和全年的財務業績和公司亮點，可在我們的網站 acurxpharma.com 上查閱。

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 fourth quarter and full year ended December 31, 2024, and then turn the call back over to Dave for his closing remarks.

今天與我一起出席的是 Acurx 總裁兼執行長 Dave Luci，他將介紹公司的最新動態和展望。接下來，我將提供截至 2024 年 12 月 31 日的第四季度和全年財務狀況的一些亮點，然後將電話轉回給戴夫進行結束語。

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 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，我們將做出某些前瞻性陳述，這些陳述基於當前資訊、假設、估計和對未來事件的預測，這些資訊、假設、估計和預測可能會發生變化，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 annual report on Form 10-K, which we filed yesterday, Monday, March 17, 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, March 18, 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描述的其他信息，包括我們昨天（2025 年 3 月 17 日星期一）提交的 10-K 表年度報告。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 3 月 18 日）現場直播之日準確。

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

現在我會把電話轉給 Dave Luci。戴夫？

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and full year 2024 and also to hear some recent updates, then we'd be pleased to take any questions.

謝謝，羅布。大家早安，非常感謝您加入我們，回顧我們 2024 年第四季和全年的財務業績，並聽取一些最新更新，然後我們很樂意回答任何問題。

First, I'd like to briefly summarize just a few of our key activities for the fourth quarter of '24, or in some cases shortly thereafter, which have been the most significant in our company's history as we are now finalizing preparation to advance our lead antibiotic candidate, ibezapolstat or IBZ as you call it for the treatment of C. difficile infection into international Phase 3 clinical trials. We believe that if successful, this last set of clinical trials to complete will be pivotal to form the basis for our new drug application in the US and marketing authorization application for the European Union.

首先，我想簡要總結我們在 2024 年第四季（或在某些情況下不久）的一些關鍵活動，這些活動是我們公司歷史上最重要的活動，因為我們現在正在做最後的準備，以推進我們的主要抗生素候選藥物 ibezapolstat 或 IBZ（您稱之為治療艱難梭菌感染）進入國際 3 期臨床試驗。我們相信，如果成功的話，這最後一組臨床試驗將為我們在美國申請新藥和在歐盟申請上市許可奠定基礎。

In October '24, we exhibited at ID Week in Los Angeles, which was the Annual Scientific Conference of the Infectious Disease Society of America, where Drs. Garey and Eubank from the University of Houston School of Pharmacy, presented a scientific poster showing that in our Phase 2b clinical trial, IBZ had comparable clinical cure and sustained clinical cure rates and safety profile to vancomycin.

2024 年 10 月，我們參加了在洛杉磯舉辦的 ID Week 展覽會，這是美國傳染病學會的年度科學會議，休斯頓大學藥學院的 Garey 博士和 Eubank 博士在會上展示了一張科學海報，展示了在我們的 2b 期臨床試驗中，IBZ 具有與萬古黴素相當的臨床治愈率和持續臨床治愈率以及安全性。

As previously reported, the overall observed clinical cure rate in the combined Phase 2 trials, Phase 2a and Phase 2b in patients with CDI was 96%, 25 out of 26 patients, and importantly, 100% or 25 of 25 of the IBZ treated patients in the Phase 2 program who had clinical cure at the end of treatment remains cured through one month after EOT as compared to just 86%, 12 or 14 patients in the vancomycin treatment arm in Phase 2b.

如前所述，在合併的 2 期臨床試驗（2a 期和 2b 期）中，CDI 患者的整體臨床治癒率為 96%，即 26 名患者中有 25 名治癒。重要的是，在 2 期臨床試驗中，接受 IBZ 治療的患者在治療結束時臨床治愈，其中 100% 或 25 名患者在治療結束一個月後仍保持治愈，而 2b 期萬古黴素治療組僅有 86% 或 12 名患者或 14 名患者治愈。

Also in a subset of ibezapolstat patients, five of five followed for three months after the end of treatment experienced no recurrence of infection. IBZ-treated patients show decreased concentration of fecal primary bile acids and higher ratios of secondary to primary bile acids than vancomycin-treated patients.

此外，在一組接受伊貝札泊司他治療的患者中，有五人在治療結束後的三個月內沒有感染復發。與接受萬古黴素治療的患者相比，接受 IBZ 治療的患者糞便初級膽汁酸濃度降低，次級膽汁酸與初級膽汁酸的比率升高。

According to Dr. Gary, these exciting results demonstrate two properties of ibezapolstat, which may contribute to its anti-recurrence effect. First, the preservation and restoration of beneficial bacteria classes in the gut provide resistance to recolonization by C. difficile. Second, these data presented for the first time indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persisting ibezapolstat-treated patients, providing another important mechanism to prevent recurrent CDI.

根據加里博士介紹，這些令人興奮的結果證明了伊貝扎泊司他的兩種特性，這可能有助於其抗復發作用。首先，腸道中有益細菌種類的保存和恢復可抵抗艱難梭菌的重新定植。其次，這些數據首次表明，這些已知的有益細菌能夠代謝初級膽汁酸和次級膽汁酸，從而持續存在於接受伊貝扎泊司他治療的患者中，為預防復發性 CDI 提供了另一種重要機制。

In November last year, we announced sponsorship and participation in the inaugural Peggy Lillis Foundation, CDI Scientific Symposium and presented ibezapolstat Phase 2b clinical data update.

去年 11 月，我們宣布贊助並參加首屆佩吉·莉利斯基金會 (Peggy Lillis Foundation)、CDI 科學研討會，並展示了 ibezapolstat 第 2b 期臨床數據更新。

In January '25, the company announced it had closed a $2.5 million registered direct offering priced at the market under Nasdaq rules. Also in January '25, we announced that we received positive regulatory guidance from the European Medicines Agency for the ibezapolstat Phase 3 clinical trial program which guidance is aligned with FDA on matters of manufacturing, non-clinical, and clinical aspects of the Phase 3 program.

25 年 1 月，該公司宣布已根據納斯達克規則完成了 250 萬美元的註冊直接發行，發行價格為市價。此外，在 2025 年 1 月，我們宣布收到了歐洲藥品管理局針對 ibezapolstat 第 3 階段臨床試驗計劃的積極監管指導，該指導在第 3 階段計劃的製造、非臨床和臨床方面與 FDA 保持一致。

The EMA guidance also confirmed ibezapolstat's regulatory pathway for our marketing authorization application to be filed by the company after successful completion of the Phase 3 clinical trials. So now with mutually consistent feedback from both the EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

EMA 指南也確認了 ibezapolstat 的監管途徑，即公司在成功完成 3 期臨床試驗後提交行銷授權申請。因此，現在有了 EMA 和 FDA 的一致回饋，Acurx 已準備好啟動我們的國際 3 期註冊計劃。

This past February and just this month, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics, two very important non-clinical studies, which we believe can leverage to show further positive differentiation for a competitive advantage of IBZ as compared with all other antibiotics used for frontline therapy to treat C. difficile infection.

今年二月和本月，我們在《抗菌劑和化學治療學雜誌》上發表了兩項非常重要的非臨床研究，我們相信，與用於治療艱難梭菌感染的一線療法的所有其他抗生素相比，這兩項研究可以進一步顯示出 IBZ 的競爭優勢。

And for that matter, given our clinical results to date, we're hopeful that this anti-recurrence effect of IBZ could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI. In February, we announced positive results from this first study conducted by Dr. Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Diseases, or NIAID. It was an in-silico study that predicted the microbiome-restorative potential of IBZ for treating C. difficile infection.

就此而言，鑑於我們迄今為止的臨床結果，我們希望 IBZ 的這種抗復發作用可以減輕對昂貴的微生物組治療劑預防復發性 CDI 的需求。今年 2 月，我們宣布了由休士頓大學的賈斯汀·麥克弗森博士開展、美國國家過敏和傳染病研究所 (NIAID) 資助的首項研究的積極成果。這是一項電腦模擬研究，預測了 IBZ 在治療艱難梭菌感染方面的微生物組修復潛力。

Our scientific advisers consider this to be a major finding, which provides a mechanistic explanation for ibezapolstat's selectivity and at the predicted bactericidal interaction between IBZ and its target, the DNA pol 3C enzyme allows regrowth of microbes known to confer health benefits. The second study conducted by Dr. Trenton Wolfe from the University of Montana was funded by NIAID, the National Cancer Institute National Center for Advancing Translational Sciences and the Company.

我們的科學顧問認為這是一項重大發現，它為伊貝扎泊司他的選擇性提供了機制解釋，並且在 IBZ 與其靶標之間預測的殺菌相互作用下，DNA pol 3C 酶允許已知具有健康益處的微生物重新生長。第二項研究由蒙大拿大學的 Trenton Wolfe 博士進行，由 NIAID、美國國家癌症研究所國家推廣轉化科學中心和該公司資助。

The second study is the first ever head-to-head comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in macomycin or metronidazole treated groups, complementing prior Phase 2 Fridays showing ibezapolstat's more selective antibacterial activity.

第二項研究是首次在無菌小鼠模型中對 IBZ 與其他抗 CDI 抗生素相關的腸道微生物組變化進行正面比較。數據顯示，與接受馬科黴素或甲硝唑治療的組別相比，接受 IBZ 治療後 α 和 β 微生物組多樣性的變化不太明顯，這與先前第 2 階段週五的研究結果相輔相成，顯示了 ibezapolstat 更具選擇性的抗菌活性。

Further, and very importantly, notable differences were observed between the microbiome of ibezapolstat and the fidaxomicin treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies. These results establish ibezapolstat's differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader-spectrum antibiotics like vancomycin and metronidazole and a narrower spectrum of microbiome alteration compared to fidaxomicin.

此外，非常重要的是，在伊貝扎泊司他治療組和非達黴素治療組的微生物組之間觀察到了顯著的差異，這可能允許在未來的研究中區分這兩種抗 CDI 抗生素。這些結果證實了伊貝札泊司他對腸道微生物群的差異化作用，顯示與萬古黴素和甲硝唑等廣譜抗生素相比，其微生物群改變的光譜更具選擇性，而與非達黴素相比，其微生物群改變的光譜更窄。

Also in February '25, last month, the Japanese patent office granted a new patent for our DNA polymerase 3C inhibitors, which expires in December 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX-375C, our preclinical antibiotic candidate, targeting the treatment of MRSA, VRE, and Anthrax infections.

同樣在上個月的 25 年 2 月，日本專利局授予了我們的 DNA 聚合酶 3C 抑制劑一項新專利，該專利將於 2039 年 12 月到期，但需延長。這為我們持續開發臨床前抗生素候選藥物 ACX-375C 奠定了重要基礎，該藥物旨在治療 MRSA、VRE 和炭疽病感染。

On March 10, just a week ago, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million. We continue to identify and pursue funding opportunities for our Phase 3 clinical trial program. We have several initiatives underway to that end and hope to have subject to report in future updates.

就在一週前的 3 月 10 日，我們宣布完成註冊直接發行和同時進行的私募，籌集的總收益為 110 萬美元。我們將繼續為我們的第三階段臨床試驗計劃尋找並尋求融資機會。為此，我們正在進行多項舉措，並希望在未來的更新中報告相關內容。

So now we've got even more momentum going into 2025 and beyond. As we have continually reported, IBZ clinical results continue to outperform in a serious and potentially life-threating infectious disease caused by C. difficile bacteria that the CDC categorize as an urgent threat and calls for new classes of antibiotics for initial treatment but also have a low incidence of recurrence.

因此，現在我們擁有了邁向 2025 年及以後的更大動力。正如我們不斷報導的那樣，IBZ 的臨床結果在由艱難梭菌引起的嚴重且可能危及生命的傳染病中繼續表現出色，疾病預防控制中心將其歸類為緊急威脅，並呼籲使用新型抗生素進行初步治療，但復發率較低。

From a regulatory perspective, FDA has granted IBZ, QIDP, and Fast Track designations for the treatment of C. difficile infection. We also believe that ibezapolstat, if approved, to make a favorable economic impact by reducing the overall annual cost burden in the US for C. difficile infection.

從監管角度來看，FDA 已授予 IBZ、QIDP 和快速通道資格，用於治療艱難梭菌感染。我們也相信，如果伊貝扎波爾司他獲得批准，它將透過降低美國艱難梭菌感染的年度總體成本負擔產生良好的經濟影響。

$5 billion annually, of which $2.8 billion is due to recurrent infection. And that's what our data shows how we may solve for. With our continuing momentum and passion to achieve success for our stakeholders, we do believe the best is yet to come.

每年損失 50 億美元，其中 28 億美元是由於反覆感染造成的。我們的數據顯示了我們可以如何解決這個問題。憑藉我們為利害關係人取得成功的持續動力和熱情，我們堅信最好的還在後頭。

And now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the fourth quarter and full year 2024. Rob?

現在回到我們的財務長 Rob Shawah，他將向您介紹我們 2024 年第四季和全年財務表現的亮點。搶？

Thanks, Dave. Our financial results for the fourth quarter and year ended December 31, 2024, were included in our press release issued earlier this morning. The company ended the year with cash totaling $3.7 million compared to $7.5 million as of December 31, 2023. The company raised a total of $6.6 million of gross proceeds under its ATM financing program for the year ended December 31, 2024.

謝謝，戴夫。我們今天早上發布的新聞稿中包含了截至 2024 年 12 月 31 日的第四季度和年度財務業績。該公司截至年底的現金總額為 370 萬美元，而截至 2023 年 12 月 31 日的現金總額為 750 萬美元。截至 2024 年 12 月 31 日的年度，該公司透過 ATM 融資計畫籌集了總計 660 萬美元的總收益。

Research and development expenses for the three months ended December 31, 2024, were $0.8 million compared to $1.9 million for the three months ended December 31, 2023, a decrease of $1.1 million. The decrease was primarily due to a decrease in consulting related costs of $1.2 million, offset by an increase in manufacturing costs of $0.1 million. For the year ended December 31, 2024, research and development expenses were $5.4 million compared to $6 million for the year ended December 31, 2023, a decrease of $0.6 million. The decrease was primarily due to a $1.6 million decrease in consulting related costs, offset by a $1 million increase in manufacturing-related costs.

截至 2024 年 12 月 31 日的三個月的研發費用為 80 萬美元，而截至 2023 年 12 月 31 日的三個月的研發費用為 190 萬美元，減少了 110 萬美元。下降的主要原因是諮詢相關成本減少 120 萬美元，但製造成本增加 10 萬美元。截至 2024 年 12 月 31 日止年度，研發費用為 540 萬美元，而截至 2023 年 12 月 31 日止年度為 600 萬美元，減少了 60 萬美元。下降的主要原因是諮詢相關成本減少了 160 萬美元，但製造相關成本增加了 100 萬美元。

General and administrative expenses for the three months ended December 31, 2024, were $2 million compared to $3.2 million for the three months ended December 31, 2023, a decrease of $1.2 million. The decrease was primarily due to a $0.5 million decrease in professional fees, a $0.5 million decrease in share-based compensation costs, and a $0.2 million decrease in employee compensation costs.

截至 2024 年 12 月 31 日的三個月的一般及行政費用為 200 萬美元，而截至 2023 年 12 月 31 日的三個月的一般及行政費用為 320 萬美元，減少了 120 萬美元。減少的主要原因是專業費用減少 50 萬美元、股權激勵成本減少 50 萬美元以及員工薪酬成本減少 20 萬美元。

For the year ended December 31, 2024, general and administrative expenses were $8.7 million compared to $8.5 million for the year ended December 31, 2023, an increase of $0.2 million. The increase is primarily due to a $0.7 million increase in professional fees, a $0.3 million increase in legal fees, offset by a $0.6 million decrease in share-based compensation costs and a $0.2 million decrease in insurance costs.

截至 2024 年 12 月 31 日止年度，一般及行政開支為 870 萬美元，而截至 2023 年 12 月 31 日止年度為 850 萬美元，增加了 20 萬美元。成長的主要原因是專業費用增加了 70 萬美元，法律費用增加了 30 萬美元，但股權激勵成本減少了 60 萬美元，保險費用減少了 20 萬美元。

The company reported a net loss of $2.8 million or $0.16 per diluted share for the three months ended December 31, 2024, compared to a net loss of $5.1 million or $0.37 per diluted share for the three months ended December 31, 2023. Net loss of $14.1 million or $0.87 per share for the full year ended December 31, 2024, compared to a net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023, all for the reasons previously mentioned.

該公司報告稱，截至 2024 年 12 月 31 日的三個月淨虧損為 280 萬美元，即每股攤薄虧損 0.16 美元，而截至 2023 年 12 月 31 日的三個月淨虧損為 510 萬美元，即每股攤薄虧損 0.37 美元。截至 2024 年 12 月 31 日的全年淨虧損為 1,410 萬美元或每股 0.87 美元，而截至 2023 年 12 月 31 日的年度淨虧損為 1,460 萬美元或每股 1.15 美元，所有原因如上所述。

The company had 17,030,686 shares outstanding as of December 31, 2024.

截至 2024 年 12 月 31 日，該公司已發行 17,030,686 股股票。

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. I'll now turn the call over to Melissa, our operator, to open the call for questions. Melissa?

謝謝羅布，也謝謝大家今天的到來。現在我將把電話轉給我們的接線生梅麗莎 (Melissa)，讓她開始回答問題。梅麗莎？

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

（操作員指示）Ed Arce，H.C. Wainwright。

This is Thomas Yip, asking a couple of questions for Ed. Thank you so much for our question. So first question for the Phase 3 program. Can you discuss some notable differences and also similarities between what the FDA and the EMA are looking forward to the Phase 3?

我是Thomas Yip，想問Ed幾個問題。非常感謝您的提問。第一個問題是關於第三階段的計劃。您能討論一下 FDA 和 EMA 對第 3 階段的期望之間的一些顯著差異和相似之處嗎？

It's identical, Thomas. We're so fortunate in that regard. We waited -- part of it is strategy. We didn't go to the European Medicines Agency until we had cleared all of the non-clinical, clinical, and manufacturing aspects with the FDA. So only with that in hand, we went with a final package to the Europeans. And it's identical protocol. There's a complete agreement in all regards from both agencies.

完全一樣，托馬斯。從這一點上來說我們非常幸運。我們等待——其中一部分是策略。直到我們通過 FDA 審查了所有非臨床、臨床和製造環節後，我們才去歐洲藥品管理局。因此，只有掌握了這一點，我們才能向歐洲人提供最後的包裹。並且其協議相同。兩個機構在所有方面都達成了完全一致。

Okay. So in that vein, how do you envision the Phase 3 program will enroll patients geographically? Will it be like a specifically split between the US and the EU? Or how do you envision to proceed?

好的。那麼從這個角度來看，您設想第三階段計畫將如何在地理上招募病患？這會不會像美國和歐盟之間的分裂一樣？或您設想如何進行？

Well, subject to the normal adjustments that you make calling audibles along the way, we're going to start out with 150 clinical trial sites. And a full half of those sites will be in Europe. And the other half will be a combination of US, Canada, and South America. I guess you can say, by a polarity, it will be more European than American. Maybe there'll be 30% of the sites in the US compared to 50% of the sites in Europe.

好吧，根據您在過程中透過呼叫聲音做出的正常調整，我們將從 150 個臨床試驗地點開始。其中一半的站點將位於歐洲。另一半將由美國、加拿大和南美洲組成。我想你可以說，從極性上來說，它更具有歐洲特色而不是美國特色。也許美國的站點佔 30%，而歐洲的站點佔 50%。

Okay. I got it. And then moving on to additional data that you have been presenting either in conferences or publications. So after this microphone study data that you published in last month, when should we expect more data with ibezapolstat this year?

好的。我得到了它。然後轉到您在會議或出版物中展示的其他數據。那麼，在您上個月發布的麥克風研究數據之後，我們什麼時候可以期待今年有關 ibezapolstat 的更多數據？

That's a very pointing question. Thanks for asking. There is a very prestigious scientific publication within which our full set of Phase 2 data will be included and published. And we think that will be sometime in the next 30 days. So that's the next one, but they appear periodically.

這是一個非常尖銳的問題。謝謝你的詢問。有一本非常有聲望的科學出版物將在其中收錄和發表我們的第二階段全套數據。我們認為這將在未來 30 天內的某個時候發生。這就是下一個，但它們會定期出現。

There's continually more and more data coming out from what we've already done from the labs at the Houston School of Pharmacy and also up in Montana.

我們在休士頓藥學院和蒙大拿州的實驗室中不斷獲得越來越多的數據。

Okay. Understood. We'll look forward to that. And then perhaps one final question from us. What actions do you have available to turn development of 375 into the clinic?

好的。明白了。我們對此充滿期待。我們還有最後一個問題。您採取了哪些措施來將 375 的發展轉化為臨床？

So we haven't taken any options off the table. Obviously, we're continuing our multistep approach to funding the company and most importantly, the Phase 3 trial. As I see it, with funding opportunities, I see the most likely opportunities with partnerships or brands, if you will, with government bodies or quasi government bodies, either in Europe or in the US.

因此，我們沒有放棄任何選擇。顯然，我們將繼續採取多步驟的方式為公司提供資金，最重要的是為第三階段試驗提供資金。在我看來，有了融資機會，最有可能的機會是與歐洲或美國的政府機構或準政府機構建立合作關係或品牌。

So I think those aspects of kind of our activities are kind of in the forefront, at least for right now, while we continue to pursue private partnerships and M&A activity. That seems to be less active than the responses we're getting from some of the government and quasi government agencies. And I think that's because folks are recognizing as more and more of our data gets out there, that we have a real drug that has a real need. And not only would it be good for the public to have this available front line for C. difficile, but it would be quite beneficial for the cost of public health because of the no recurrences.

因此，我認為，至少目前，我們的這些活動處於領先地位，同時我們繼續尋求私人合作夥伴關係和併購活動。這似乎不如我們從一些政府和準政府機構得到的回應那麼積極。我認為這是因為隨著越來越多的數據被公開，人們認識到我們確實有一種真正需要的藥物。擁有這種治療艱難梭菌的第一線藥物不僅對公眾有益，而且由於不會復發，對公共衛生成本也非常有利。

Understood. If I may, just one additional question, actually. Just wonder if your plan is still to look for a partnership to move to ibezapolstat into Phase 3? Or is there other options as well?

明白了。如果可以的話，我實際上還有一個問題。只是想知道您的計劃是否仍是尋找合作夥伴以將 ibezapolstat 推進到第 3 階段？或是有其他選擇嗎？

Yes. I mean we're looking for a partnership. But remember, we used the term partnership broadly to include a number of different agencies of the government along with the private sector. So in a broad sense, yes, that's still the plan.

是的。我的意思是我們正在尋求合作夥伴關係。但請記住，我們使用的合作夥伴關係一詞含義廣泛，包括政府的許多不同機構以及私營部門。所以從廣義上講，是的，這仍然是計劃。

Okay. Understood. Thank you so much for taking our questions (inaudible).

好的。明白了。非常感謝您回答我們的問題（聽不清楚）。

James Molloy, Alliance Global Partners.

聯盟全球合作夥伴的詹姆斯‧莫洛伊 (James Molloy)。

Thank you very much for taking my questions. I was just wondering if you can characterize the partnership environment and there was a lot of turmoil in the market earlier has that impacted your ability to secure partnerships. Is this something you think will happen in the 2025 time frame? Or is this a 2026 event? And sort of any -- and I know that perhaps that leads into the next question. One, I think you'll start the Phase 3s, but I guess it depends quite a bit upon either partnership or funding events, right?

非常感謝您回答我的問題。我只是想知道您是否可以描述一下合作環境，之前市場出現了很多動盪，影響了您建立合作關係的能力。您認為這會在 2025 年內發生嗎？還是這是 2026 年的活動？以及任何——我知道這也許會引出下一個問題。首先，我認為你們會啟動第三階段，但我想這很大程度上取決於合作夥伴關係或融資活動，對嗎？

Yes. I agree and I agree. The tumultuous nature of the things happening in the world today certainly present even more team challenged than we were facing coming into '25. But we feel that we're up for the challenge, and we're going to continue to fight. I do see potential partnerships with various groups throughout the world that are not pharmaceutical companies as being kind of further along at this point than private sector partnerships. But we're continuing our efforts in both regards.

是的。我同意，我同意。當今世界發生的事件的動盪性質無疑給我們的團隊帶來了比 25 年更大的挑戰。但我們覺得我們已經準備好迎接挑戰，我們將繼續戰鬥。我確實認為，與世界各地非製藥公司的各種團體建立潛在的合作夥伴關係目前比私營部門的合作夥伴關係更進一步。但我們將繼續在這兩方面做出努力。

I have been to Washington, D.C., on Capitol Hill several times now. And I can tell you firsthand that everyone is looking over their shoulder down there right now. And it's a different vibe than I experienced when I was in Capitol Hill back in September. So hopefully, things settle down over the next couple of months, and we can get down to some appropriations.

我已去過華盛頓特區國會山莊好幾次了。我可以親口告訴你，現在每個人都在擔心自己的安全。這與我九月在國會山莊時感受到的氛圍不同。因此，希望事情在接下來的幾個月內能夠穩定下來，然後我們就可以開始撥款了。

But there are still appropriations from prior approvals, government approved programs that we're chasing down in one case of applied for. So we're continuing to process I think something will happen in 2025 that will allow us to start the Phase 3 trials with enrollment.

但仍有來自先前批准的撥款，即政府批准的項目，我們正在追查其中一項申請。因此，我們正在繼續處理，我認為 2025 年將會發生一些事情，讓我們能夠開始進行第 3 階段試驗並進行招募。

There may be a time lag between that event and the enrollment starting just because we don't want to make our fill finish pill form until we're serving to have the money to start the trial because we don't want to date the packages before we have to. So that's the final step, and that will take place after the money comes in. So that may present a few months time lag between having the sufficient funding and starting the enrollment. Does that answer your question?

活動和開始招募之間可能會有時間差，因為我們不想在有錢開始試驗之前就製作完成藥丸表格，因為我們不想在必須之前就給包裹註明日期。這是最後一步，將在資金到位後進行。因此，在獲得足夠的資金和開始招生之間可能會有幾個月的時間差。這回答了你的問題嗎？

It does indeed. I know there's a lot of uncertainty on these things, of course. Should you get this trial started, what the current expectation for (inaudible) have top line data or an interim look? Where do you think that could occur should the trial start tomorrow?

確實如此。當然，我知道這些事情存在著許多不確定性。您是否應該開始這項試驗，目前對（聽不清楚）的期望是什麼，是否有頂線數據或中期觀察？如果明天開始審判，您認為這種情況會在哪裡發生？

Yes. Well, so the interim look, we decided against the interim look because statistically, it as like 10% to the required number of patients in the trial. And it wouldn't really provide us anything other than an advisory committee would tell us keeping rolling or futility. We wouldn't be able to see any of the numbers with being a double-blind study. So we didn't do the interim look, but I think it would be two years from first patient enrolled to top line data.

是的。好吧，因此，我們決定不進行中期觀察，因為從統計上講，它只佔試驗所需患者數量的 10%。它實際上不會給我們任何東西，除了諮詢委員會告訴我們繼續前進或徒勞無功。如果是雙盲研究，我們將無法看到任何數字。因此，我們沒有進行中期觀察，但我認為從第一位患者入組到獲得頂線資料需要兩年時間。

All right. Excellent. That [answers] my questions. Thank you very much for taking it.

好的。出色的。這回答了我的問題。非常感謝您接受它。

(Operator Instructions) Claire Aitchison, Independent Investment Research.

（操作員指示）Claire Aitchison，獨立投資研究。

Just a couple of things for me. I just noticed that you've made mention of the suspension of the ATM program in January. I was just wondering if you could talk a little bit about what's happening there? And then also if you could just comment on the risk with the Nasdaq listing given where the share price is currently trading.

對我來說只有幾件事。我剛剛注意到您提到了一月份 ATM 計劃的暫停。我只是想知道您是否可以談談那裡發生的事情？另外，您是否可以根據目前的股價來評論一下納斯達克上市的風險？

Sure. So we suspended the ATM in connection with the offering that we are conducting in January. And we can put the ATM back in place and reactivated, so to speak, when the company management decides to do that. So there's no prohibition on us reactivating the ATM. It's currently not part of our ongoing plan, which will unfold over the next several months.

當然。因此，我們在 1 月進行的發行活動中暫停了 ATM 機的使用。當公司管理階層決定這麼做時，我們可以將 ATM 放回原位並重新啟用。因此，我們並沒有被禁止重新啟動 ATM。目前它還不是我們正在進行的計劃的一部分，該計劃將在未來幾個月內展開。

But with the delisting, I can tell you, Claire, that there's no sense internally that we'll let the Nasdaq listing go. And we're working on some things which we think will help with the listing in that regard. So we're -- leave it with us for now. But the last thing I would expect to see is for us to be traded at the (inaudible).

但是，對於退市，我可以告訴你，克萊爾，我們內部沒有理由放棄納斯達克上市。我們正在做一些我們認為有助於上市的事情。所以我們——現在就把它留給我們。但我最不希望看到的是，我們被交易到（聽不清楚）。

Okay. So you're confident you'll be able to manage that.

好的。所以你有信心你能夠做到這一點。

Yes. Absolutely.

是的。絕對地。

Okay. Great. Thank you.

好的。偉大的。謝謝。

Thank you. Ladies and gentlemen, this concludes our question-and-answer session and will conclude our call today. We thank you for your interest and participation. You may now disconnect your lines.

謝謝。女士們、先生們，我們的問答環節到此結束，今天的電話會議也將結束。我們感謝您的關注與參與。現在您可以斷開線路了。

Thank you, Melissa.

謝謝你，梅麗莎。

Thank you.

謝謝。