Acurx Pharmaceuticals Inc (ACXP) 2025 Q4 法說會逐字稿

Greetings and welcome to Acurx Pharmaceuticals conference call to discuss full year and fourth quarter 2025 financial results. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Thank you. Please go ahead.

各位好，歡迎參加 Acurx Pharmaceuticals 的電話會議，討論 2025 全年及第四季財務結果。(接線員指示) 提醒各位，本次會議將被錄音。現在我很榮幸介紹本次會議主持人，Acurx 首席財務官 Rob Shawah。謝謝。請開始。

Thank you, [Donna]. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the year ended and fourth quarter 2025, which is available on our website at acurxpharma.com.

謝謝，[Donna]。各位早安，歡迎參加本次電話會議。今天早上，我們已發布新聞稿，提供截至 2025 年度及 2025 年第四季的財務結果與公司重點摘要，新聞稿可於我們網站 acurxpharma.com 查閱。

Joining me today are Bob DeLuccia, Executive Chairman of Acurx; Dr. Michael Silverman, Medical Director of Acurx who will be available for questions related to our R&D activities and strategy during the Q&A period; and David Luci, President and CEO of Acurx who will start by providing a corporate update and outlook.

今天與我一同出席的有：Acurx 執行董事長 Bob DeLuccia；Acurx 醫學總監 Michael Silverman 醫師，他將在問答環節就我們的研發活動與策略相關問題提供回覆；以及 Acurx 總裁兼執行長 David Luci，他將先就公司近況與展望進行更新。

Following that, I'll provide some highlights of the financials from the year and fourth quarter ended December 31, 2025, and then turn the call back over to Dave for his closing remarks. 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.

之後，我將說明截至 2025 年 12 月 31 日止年度及第四季的部分財務重點，接著再把電話交回 Dave 作結語。提醒各位，在今天的電話會議中，我們將發表若干前瞻性陳述；這些陳述係基於目前資訊、假設、估計與對未來事件的預測，可能變動，並涉及多項風險與不確定性，可能導致實際結果與前瞻性陳述所述內容出現重大差異。

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, Thursday, March 12, 2026. 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.

投資人應考量這些風險以及我們向美國證券交易委員會（SEC）提交之文件中所述的其他資訊，包括我們的 Form 10-K 年度報告；該報告已於昨日（2026 年 3 月 12 日，星期四）提交。敬請注意勿過度依賴這些前瞻性陳述，Acurx 亦不承擔於未來任何時間更新此等陳述之義務。

This conference call contains time-sensitive information that's accurate only as of the date of the slide broadcast today, March 13, 2026. I'll now turn the call over to David Luci. Dave?

本次電話會議包含具時效性的資訊，僅在今日（2026 年 3 月 13 日）投影片直播之日期當日為準確。現在我把電話交給 David Luci。Dave？

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and year ended December 31, 2025, and also to hear some recent updates, which we're excited about, 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 fourth quarter of '25 or in some cases, shortly thereafter.

謝謝，Rob。各位早安，非常感謝各位加入我們，一同回顧截至 2025 年 12 月 31 日止第四季與全年財務結果，也聽取一些我們感到振奮的最新進展；之後我們也很樂意回答各位的問題。首先，我想簡要總結 2025 年第四季（或部分在其後不久）我們幾項關鍵活動。

First, in October, the company received gross proceeds from the execution of 170,000 Series F Warrants of approximately $1.4 million. Also in October, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline.

第一，於 10 月，公司因行使 170,000 份 F 系列認股權證而取得約 140 萬美元的總募集款。同樣在 10 月，我們是五家於亞特蘭大 IDWeek「研發管線中的新型抗微生物藥物」專場進行正式簡報的公司之一。

Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, who is with us this morning, and Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical program.

代表 Acurx 進行簡報的是我們的醫學總監 Michael Silverman 醫師（今天早上也在場），以及 Kevin Garey 醫師（休士頓大學藥學院教授兼系主任），他亦為 ibezapolstat 臨床計畫中微生物學與微生物組相關面向的主要研究者。

The company's presentation included an update on ibezapolstat and its microbiome sparing properties. Also, presented were new colonic-microbiome data from a state-of-the-art mouse infection model, showing a potential microbiome-sparing class effect of representative compounds from our DNA pol IIIC inhibitor preclinical pipeline.

公司簡報內容包含 ibezapolstat 的最新進展，以及其「保護微生物組（microbiome-sparing）」特性。同時也展示了來自最先進小鼠感染模型的最新結腸微生物組數據，顯示我們 DNA pol IIIC 抑制劑臨床前管線中代表性化合物可能具有保護微生物組的類別效應。

In describing the work performed at its laboratory at the University of Houston, Dr. Garey stated, initial work on a novel lead DNA pol IIIC inhibitor compounds indicate that the positive microbiome-sparing results from our ibezapolstat studies may be a class effect. This is an important finding because microbiome sparing likely contributed to ibezapolstat's sustained efficacy in the Phase II trial for C. diff infection where no patient cured of CDI experienced a recurrence.

在描述休士頓大學實驗室所進行的研究時，Garey 醫師表示，針對新型 DNA pol IIIC 抑制劑先導化合物的初步研究顯示，我們在 ibezapolstat 研究中觀察到的正向「保護微生物組」結果，可能是一種類別效應。這是一項重要發現，因為保護微生物組很可能促成 ibezapolstat 在困難梭狀芽孢桿菌（C. diff）感染第二期（Phase II）試驗中的持續療效；在該試驗中，所有治癒 CDI 的病患均未出現復發。

In our recent experiments, mice given the comparator antibiotic Linezolid demonstrated an overabundance of uncommon and harmful gram-negative bacteria known to contribute to recurrence of infection. Dr. Garey further stated, these data indicates a low probability for DNA pol IIIC inhibitors to increase the risk of causing a C. diff infection.

在我們近期實驗中，給予對照抗生素 Linezolid 的小鼠，出現不常見且有害的革蘭氏陰性菌過度增生，而這類菌已知會促成感染復發。Garey 醫師進一步表示，這些數據顯示 DNA pol IIIC 抑制劑提高引發 C. diff 感染風險的機率很低。

Vancomycin resistant Enterococcus or other gut microbiome-related infections. In November, the company announced that the Nature Communications Scientific Journal published results from its scientific collaboration with Leiden University Medical Center demonstrating structural biology research that reveals for the first time a DNA pol IIIC inhibitor, ibezapolstat, bound to its target.

包括萬古黴素抗藥性腸球菌（VRE）或其他與腸道微生物組相關的感染。11 月，公司宣布《Nature Communications》科學期刊發表了我們與荷蘭萊頓大學醫學中心（Leiden University Medical Center）的科學合作成果，展示結構生物學研究，首次揭示 DNA pol IIIC 抑制劑 ibezapolstat 與其標的結合的結構。

The publication has entitled: A unique inhibitor transformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens. This is an important milestone in Acurx's highly productive scientific collaboration with Leiden University Medical Center in Holland in advancing development of these new-to-nature compounds fortifying the foundation for the rational development of this innovative class of antimicrobials against other Gram-positive priority pathogens.

該論文題為：A unique inhibitor transformation selectively targets the DNA polymerase PolC of Gram-positive priority pathogens。這是 Acurx 與荷蘭萊頓大學醫學中心高產出的科學合作中的一項重要里程碑，有助於推進這些「自然界新穎（new-to-nature）」化合物的開發，並強化以理性設計方式開發此創新抗微生物藥物類別之基礎，以對抗其他革蘭氏陽性優先病原體。

On March 9, 2026, we issued a press release announcing that we are launching a groundbreaking ibezapolstat clinical trial program in patients with recurrent CDI that has the potential to shift the treatment paradigm and the prevention of rCDI from two agents to one agent.

2026 年 3 月 9 日，我們發布新聞稿宣布，將在復發性 CDI（rCDI）患者中啟動一項具突破性的 ibezapolstat 臨床試驗計畫；該計畫有潛力改變治療典範，將 rCDI 的治療與預防從兩種藥物策略轉變為單一藥物策略。

When coupled with ibezapolstat Phase II results of being highly effective, 96% clinical cure in 26 patients, in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezapolstat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of recurrent CDI.

結合 ibezapolstat 第二期結果——在 26 名患者中治療急性 CDI 的臨床治癒率達 96%，且在保護腸道微生物組的同時，治癒患者未見復發——這項新試驗將使 ibezapolstat 成為有望首度在「CDI 治療」與「復發性 CDI 預防」兩方面皆展現臨床成功的候選藥物。

In our Phase II trial, all 25 patients treated with ibezapolstat who experienced a clinical cure were free of recurrence one month after treatment and five out of five of these patients were observed for three months after treatment, and they remained free of recurrence. During our Q&A this morning, members of our R&D team will be available to answer any questions about this new trial program.

在我們的第二期試驗中，接受 ibezapolstat 治療且達到臨床治癒的 25 名患者，在治療後一個月皆未復發；其中有 5 位患者在治療後追蹤三個月，亦持續未復發。在今天早上的問答環節，我們研發團隊成員將可回答關於此新試驗計畫的任何問題。

But briefly, this new clinical trial in rCDI begins with an open-label pilot trial to gain experience with ibezapolstat in patients with multiply recurrent CDI with at least three episodes of CDI within the past 12 months. This will inform elements of the planned active controlled Phase III registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial.

簡要而言，這項針對 rCDI 的新臨床試驗將先以開放標籤（open-label）先導試驗開始，以累積 ibezapolstat 用於多次復發 CDI 患者的經驗；此類患者在過去 12 個月內至少發生 3 次 CDI。該先導試驗將為規劃中的 rCDI 適應症「主動對照」第三期（Phase III）註冊試驗提供設計要素；在開放標籤 20 名患者試驗取得有利結果後，將進一步推動實施。

Upon subsequent successful completion of the Phase III pivotal rCDI trial, and per the operative FDA procedure, the company plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry published in 2020.

在後續成功完成第三期關鍵性 rCDI 試驗後，並依據 FDA 的作業程序，公司計畫依循 FDA 於 2020 年發布之《抗菌與抗黴菌藥物有限族群途徑（Limited Population Pathway for Antibacterial and Antifungal Drugs）產業指引》，向 FDA 申請 rCDI 的治療與預防適應症核准。

Acurx's clinical program in the broader CDI patient population is ready to advance to Phase III international pivotal clinical trials. In this regard, we're very excited about the FDA's recent announcement published in the New England Journal of Medicine that a one-trial requirement will be FDA's new default standard for registration. If formalized, this would end the long-standing two-trial dogma.

Acurx 在更廣泛 CDI 患者族群的臨床計畫，已準備推進至第三期國際關鍵性臨床試驗。就此而言，我們對 FDA 近期在《新英格蘭醫學期刊》發布的公告感到非常振奮；該公告指出，「單一試驗」要求將成為 FDA 註冊審查的新預設標準。若正式定案，這將終結長期以來「需兩項試驗」的既定教條。

We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. In February 2026, we announced that the U.S. Patent and Trademark Office granted a new patent for our Pol IIIC inhibitors, covering composition of matter and method of use.

我們期待 FDA 進一步釐清，以及對我們臨床開發計畫可能帶來的有利影響，例如有機會僅以一項關鍵性臨床試驗，便可針對更廣泛的 CDI 族群尋求上市核准。2026 年 2 月，我們宣布美國專利商標局已核發一項針對我們 Pol IIIC 抑制劑的新專利，涵蓋物質組成與使用方法。

This patent extends to December 2039, subject to extension under U.S. patent rules. We continue to identify and pursue funding opportunities for our Phase III clinical trial program for ibezapolstat as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end and we'll report in future updates as appropriate.

該專利有效期延伸至 2039 年 12 月，並可依美國專利規則申請延長。我們持續辨識並追求 ibezapolstat 第三期臨床試驗計畫的資金機會，同時也考量其他可行的財務途徑以達成成功。為此我們已推動數項措施，並將在適當時於後續更新中報告。

As we've continually reported, ibezapolstat clinical and nonclinical results continue to outperform in a serious and potentially life-threading infectious disease caused by C. difficile bacteria that the CMC categorized as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

如我們持續所報告，ibezapolstat 的臨床與非臨床結果在一種由艱難梭菌（C. difficile）所致、嚴重且可能危及生命的感染性疾病中持續表現優異；CMC 將其列為迫切威脅，並呼籲需要新的抗生素類別用於初始治療，同時具備低復發率。

Additionally, ibezapolstat has qualified infectious disease product and FastTrack designations from the FDA for the treatment of C. difficile infection as well as SME or small and medium enterprise status in Europe. We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector.

此外，ibezapolstat 已獲 FDA 授予用於治療艱難梭菌感染的「合格感染性疾病產品」（QIDP）與「快速通道」（Fast Track）資格認定，並在歐洲取得 SME（中小企業）身分。我們仍然有信心，隨著 ibezapolstat 的競爭優勢持續演進並增強，我們將能在總體經濟環境與產業領域的艱困時期中持續成功前行。

And now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the full year and fourth quarter ended December 31, 2025. Rob?

現在把時間交回給我們的財務長 Rob Shawah，帶領各位回顧截至 2025 年 12 月 31 日止全年與第四季的財務結果重點。Rob？

Thanks, Dave. Our financial results for the fourth quarter and year ended December 31, 2025, were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.6 million compared to $3.7 million as of December 31, 2024.

謝謝，Dave。截至 2025 年 12 月 31 日止第四季與全年財務結果，已包含在我們今天稍早發布的新聞稿中。公司年末現金總額為 760 萬美元，相較於 2024 年 12 月 31 日的 370 萬美元。

During the quarter, the company raised a total of approximately $1.5 million of gross proceeds through purchases under the Equity Line of Credit with gross proceeds of purchases under the Equity Line of Credit totaling approximately $4 million for the full year of 2025. Research and development expenses for the three months ended December 31, 2025, were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million.

本季公司透過股權信用額度（Equity Line of Credit）下的購買，募集約 150 萬美元的總募集款；2025 全年透過該股權信用額度購買所取得的總募集款約為 400 萬美元。截至 2025 年 12 月 31 日止三個月的研發費用為 30 萬美元，相較於截至 2024 年 12 月 31 日止三個月的 80 萬美元，減少 50 萬美元。

The decrease was due primarily to a decrease in manufacturing costs of $0.2 million and a decrease in consulting costs of $0.3 million as a result of prior year trial-related expenses. For the 12 months ended December 31, 2025, research and development expenses were $1.8 million versus $5.4 million for the 12 months ended December 31, 2024.

該減少主要由於製造成本減少 20 萬美元，以及因前一年度與試驗相關費用所致的顧問費用減少 30 萬美元。截至 2025 年 12 月 31 日止 12 個月的研發費用為 180 萬美元，相較於截至 2024 年 12 月 31 日止 12 個月的 540 萬美元。

The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing-related costs and a $1 million decrease in consulting costs as prior year had higher expenses related to Phase IIb and Phase III preparation costs. General and administrative expenses for the three months ended December 31, 2025, were $1.3 million compared to $2 million for the three months ended 2024 -- December 31, 2024, a decrease of $0.7 million.

減少的 360 萬美元主要來自製造相關成本減少 260 萬美元，以及顧問費用減少 100 萬美元，原因是前一年度在 IIb 期與 III 期準備成本方面支出較高。截至 2025 年 12 月 31 日止三個月的一般及行政費用為 130 萬美元，相較於截至 2024 年 12 月 31 日止三個月的 200 萬美元，減少 70 萬美元。

The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees. For the 12 months ended December 31, 2025, general and administrative expenses were $6.3 million versus $8.7 million for the 12 months ended December 31, 2024, a decrease of $2.4 million.

該減少主要由於薪酬相關成本減少 30 萬美元，以及專業費用減少 30 萬美元。截至 2025 年 12 月 31 日止 12 個月的一般及行政費用為 630 萬美元，相較於截至 2024 年 12 月 31 日止 12 個月的 870 萬美元，減少 240 萬美元。

The decrease was primarily due to a $0.9 million decrease in professional fees, a $1.4 million decrease in share-based compensation, a $0.4 million decrease in compensation costs, partially offset by a $0.3 million increase in legal costs.

該減少主要由於專業費用減少 90 萬美元、以股份為基礎的薪酬減少 140 萬美元，以及薪酬成本減少 40 萬美元；部分被法律成本增加 30 萬美元所抵銷。

The company reported a net loss of $1.6 million or $0.73 per diluted share for the three months ended December 31, 2025, compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8 million or $5.32 per diluted share for the 12 months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the 12 months ended December 31, 2024, all for the reasons previously mentioned. The company had 2,348,113 shares outstanding as of December 31, 2025.

公司截至 2025 年 12 月 31 日止三個月的淨損為 160 萬美元（稀釋後每股虧損 0.73 美元），相較於截至 2024 年 12 月 31 日止三個月的淨損 280 萬美元（稀釋後每股虧損 3.29 美元）；截至 2025 年 12 月 31 日止 12 個月的淨損為 800 萬美元（稀釋後每股虧損 5.32 美元），相較於截至 2024 年 12 月 31 日止 12 個月的淨損 1,410 萬美元（每股虧損 17.45 美元），原因皆如前述。截至 2025 年 12 月 31 日，公司流通在外股數為 2,348,113 股。

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

接下來我把電話交回給 Dave。

Thanks, Rob, and to all of you for joining us today. Before bringing our operator Donna back to open the call for questions, I'm pleased to welcome to the call, Michael Silverman, and Bob DeLuccia, our Medical Director and Executive Chairman, respectively, to assist with further explanation of our recurrent C. difficile infection trial program. Bob, would you like to add any comments?

謝謝，Rob，也謝謝各位今天參與。在請我們的接線員 Donna 回來開放提問之前，我很高興歡迎 Michael Silverman 與 Bob DeLuccia 加入本次電話會議；他們分別是我們的醫療總監與執行董事長，將協助進一步說明我們的復發性艱難梭菌感染試驗計畫。Bob，你是否想補充幾點？

Sure. Thanks, Dave. And as you said, these are very challenging times, but we think we can rise above them head on with our new clinical development plan. I think in Phase II, as Dave said, ibezapolstat was demonstrated to be highly effective in both curing the acute C. diff infection and in preventing recurrence.

當然。謝謝，Dave。如你所說，這段時間確實非常艱難，但我們認為可以透過新的臨床開發計畫正面迎戰並克服。我認為在第二期試驗中，如 Dave 所說，ibezapolstat 已被證明在治癒急性 C. diff 感染以及預防復發方面都非常有效。

So based on this, we believe it has the potential to be the first to demonstrate clinical success in both the treatment of the infection and the prevention of recurrent CDI. And such success would shift the paradigm of treatment and prevention of rCDI from two agents to one.

因此基於此，我們相信它有潛力成為首個在感染治療與復發性 CDI 預防兩方面皆展現臨床成功的藥物。而這樣的成功將把 rCDI 的治療與預防典範從兩種藥物轉變為一種。

And I think this would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the U.S., results in approximately 30,000 deaths, and it generates a related public health cost burden of approximately $5 billion, of which $2.8 billion is related to recurrent CDI.

我也認為，這將對公共衛生威脅帶來重大改變：在美國每年約有 50 萬名 CDI 患者，約造成 3 萬人死亡，並帶來約 50 億美元的相關公共衛生成本負擔，其中 28 億美元與復發性 CDI 有關。

I also think that our new clinical program strengthens ibezapolstat's competitiveness and if approved for marketing, gives an even more attractive value proposition in the marketplace, and which, by the way, ibezapolstat commercial supply chain of active pharmaceutical ingredient and packaged product will be made in America. Thanks, Dave.

我也認為，我們新的臨床計畫強化了 ibezapolstat 的競爭力；若獲准上市，將在市場上提供更具吸引力的價值主張；順帶一提，ibezapolstat 的商業化供應鏈（包含原料藥與包裝成品）將在美國製造。謝謝，Dave。

Thanks, Bob. And now back to Donna, our operator, for today's call for questions. Donna?

謝謝，Bob。現在把時間交回給我們的接線員 Donna，開始今天的提問環節。Donna？

(Operator Instructions)

（接線員指示）

Jason McCarthy, Maxim Group.

Jason McCarthy，Maxim Group。

Good morning, guys. Thanks for taking the questions. I have a few, so if you just bear with me. Starting with the new recurrent CDI trial, for the primary endpoint for -- I'm assuming it's prevention of recurrence, how far out do you have to go? Is it three months, six months, one month and so on? And what is the cost of that trial?

各位早安。謝謝讓我提問。我有幾個問題，請多包涵。先從新的復發性 CDI 試驗開始，主要終點——我假設是預防復發——你們需要追蹤到多長時間？是三個月、六個月、一個月等等嗎？那項試驗的成本是多少？

Bob?

Bob？

First question was how far out, you mean in terms of evaluation through the end point? How long?

第一個問題是你說的「多遠」是指評估到終點的時間嗎？多久？

Yes, sir.

是的，先生。

Mike, you can take that question, if you like. Just explain treatment period as well as the follow-up period.

Mike，如果你願意，你可以回答這個問題。也請說明治療期以及追蹤期。

Sure. Thanks for the question, Michael Silverman here. Following the end of treatment, we will observe patients for recurrent disease to a first endpoint, a primary assessment endpoint of eight weeks. That's based on other products that are out there having been approved for prevention of recurrent disease.

當然。謝謝你的提問，我是 Michael Silverman。在治療結束後，我們將觀察病人是否有疾病復發，直到第一個終點，也就是主要評估終點：八週。這是基於其他已獲核准、用於預防復發疾病的產品。

The standard there has been weeks, suppressant has been eight weeks. So that will be our endpoint for recurrent disease. We will continue to follow patients out for approximately six months after the end of therapy to gather additional data.

那邊的標準一直是以週為單位，抑制治療是八週。因此，這將是我們針對復發疾病的終點。在療程結束後，我們會持續追蹤病人約六個月，以蒐集額外資料。

Okay. Just as a follow-up to that, when you go out to six months in general, what do you see as the rate of recurrence with vanc or any other treatment that they're getting on average?

好的。就此再追問一下，一般來說，當你追蹤到六個月時，使用萬古黴素（vanc）或其他平均正在接受的治療，你看到的復發率大概是多少？

Well. Yeah, it's a good question. We may not have data after six weeks on the drugs that are out there that has not necessarily been the standard follow-up. Vancomycin, we can see rates of recurrence between 20% and 40%. For the anti-recurrence therapies that are out there like (inaudible) those recurrence rates are down in the range of 15% to 30%. And I'm talking about eight weeks label indication.

嗯。是的，這是個好問題。對於市面上的藥物，我們在六週之後可能沒有資料，因為那不一定是標準追蹤期。萬古黴素的復發率大約在 20% 到 40% 之間。至於市面上用於抗復發的療法，例如（聽不清），復發率大約在 15% 到 30% 的範圍。我指的是標籤適應症為八週的情況。

Okay, Jason?

好的，Jason？

Got it. Yes.

了解。是的。

Good. Dave, do you want to address the cost question?

很好。Dave，你要回答成本的問題嗎？

The only thing I think we left out is the treatment period. I think there's a small modification to that, Jason. Bob, do you want to provide that?

我想我們唯一漏掉的是治療期。我想那裡有個小幅調整，Jason。Bob，你要補充一下嗎？

Go ahead, Mike. The initial treatment...

你先說吧，Mike。初始治療……

Sure. You may recall that in our prior trials, we've used a 10-day treatment period because, again, that's been standard of practice, standard of care for the other drugs that are approved, vancomycin, fidaxomicin. For this trial, for the recurrent disease trial, we're going to a 14-day treatment period for all patients that's based on prior work that's been done in the anti-recurrence drug -- with the anti-recurrence agents longer period of treatment for the acute episode may result in a higher cure rate, which would give us a more robust sample size in which to evaluate recurrence.

好的。你可能記得在我們先前的試驗中，我們使用 10 天的治療期，因為那一直是臨床實務與照護標準，也是其他已核准藥物（萬古黴素、費達黴素 fidaxomicin）的標準。在這次試驗、也就是復發疾病試驗中，我們將所有病人的治療期延長到 14 天，這是基於先前在抗復發藥物上的研究——使用抗復發藥物時，急性發作採用較長的治療期可能帶來較高的治癒率，從而讓我們有更穩健的樣本量來評估復發。

And the cost ?

那成本呢？

Yes, it's in the range of $4 million to $5 million.

是的，大約在 400 萬到 500 萬美元之間。

So it's likely that the current cash balance maybe with a little bit of a top-off gets you through this, I guess, we call it a pilot study in recurrent CDI. And is that something that we could see the start and conclusion of in 2026?

所以看起來目前的現金餘額，可能再稍微補一些，就能支應這個——我想我們稱之為復發性 CDI 的試點研究。那這是否有機會在 2026 年看到啟動並完成？

We'll certainly start enrolling in 2026 in the second half. But then we'll see how far we get with the enrollment. We think we have some really high enrolling centers, but we wouldn't expect to be fully enrolled for about 12 to 15 months. I should add, Jason, that we also have our ELOC, right? So in terms of topping off, we have between $7 million to $8 million left on our ELOC.

我們肯定會在 2026 年下半年開始收案。但之後要看收案進度。我們認為有一些收案量很高的中心，但我們預期要到大約 12 到 15 個月才會完成收案。我還要補充一下，Jason，我們也有 ELOC，對吧？所以就「補一些」而言，我們的 ELOC 還剩下 700 萬到 800 萬美元。

Okay. Perfect. And then just two more quick ones, and then I'll jump back. So if this pilot is successful, does it change and you're starting to think about recurrent CDI for the Phase III, does that change the size, the potential size of a Phase III because if it was acute, I think it was somewhere in that 400 to 500 patients per trial to Phase IIIs. I know that the that narrative seems to be changing to one Phase III these days.

好的。完美。再兩個快問我就回到隊列。如果這個試點成功，且你們開始考慮在三期（Phase III）做復發性 CDI，這會不會改變三期試驗的規模、潛在規模？因為如果是急性，我記得每個三期試驗大概是 400 到 500 位病人。我知道現在的說法似乎正在改變，近年來好像只做一個三期。

But just for recurrent CDI in general, do you need less patients to get an approval versus acute?

但就復發性 CDI 而言，與急性相比，你們是否需要更少的病人就能獲得核准？

Yeah. Thank you, Jason, for that question. Mike, you can answer that in terms of what we are projecting for the follow-on trial to the open label? We have a range of estimates right now, but it depends upon what we see in the open-label trial, right?

是的。謝謝你，Jason，這個問題。Mike，你可以就我們對開放標籤試驗後續試驗的預估來回答嗎？我們目前有一個估計範圍，但取決於我們在開放標籤試驗中看到的結果，對吧？

Yeah, I'd like to emphasize what Bob said. Right now, we don't have any treatment data with ibezapolstat in this patient population. So we don't know the true effect size. We have very good estimates of the other agents that are out there, Jason, as you mentioned. But we still need to gather data on the ibezapolstat in terms of clinical cure rate and prevention of recurrence.

是的，我想強調 Bob 說的。目前我們在這個病人族群中，還沒有任何使用 ibezapolstat 的治療資料。所以我們不知道真正的效應量（effect size）。如你所提，Jason，我們對其他現有藥物有很好的估計。但我們仍需要蒐集 ibezapolstat 的資料，包括臨床治癒率以及預防復發的效果。

Based on what we think are reasonable assumptions that is going back to our Phase II trial in a slightly different patient population, we're currently projecting somewhere between 360 and 400 patients for a single trial in the recurrent CDI indication.

基於我們認為合理的假設——回溯到我們在稍微不同病人族群中的二期試驗——我們目前預估在復發性 CDI 適應症下，單一試驗大約需要 360 到 400 位病人。

Got it. Okay. That makes sense. And then just lastly, I know you guys -- you had mentioned U.S.-based manufacturing, which seems to be a very important issue these days with the current administration. Is that something that you're really trying to make headway with regulators on or the current administration in terms of having -- you could see pol IIIC inhibitor being used in lots of different things, maybe it's something the government is interested in stockpiling.

了解。好的。這很合理。最後一個問題，我知道你們——你們提到以美國為基地的製造，這在現任政府下似乎是非常重要的議題。你們是否真的在這方面努力與監管機關或現任政府取得進展？因為你們可以看到 pol IIIC 抑制劑可用於很多不同領域，也許政府有興趣把它納入戰略儲備。

David, do you want to just kind of opine if you would, on that aspect of the U.S.-based manufacturing?

David，你是否願意就以美國為基地的製造這一面向，稍微談談你的看法？

Yeah. I think you hit it pretty straight on, Jason. We're continuing to have detailed discussions with government agencies, including BARDA, and it's important to them in their consideration of a public-private partnership that our program be made in America. So that's part of what makes them excited about getting appropriate funding allocated to each sponsor that's looking for government money, as you say, these days under this administration.

是的。Jason，我覺得你說得很到位。我們持續與政府機構進行深入討論，包括 BARDA；而在他們考量公私協力夥伴關係時，我們的計畫必須「美國製造」對他們很重要。因此，這也是讓他們對於把適當資金分配給每個尋求政府資金的贊助方感到興奮的一部分——如你所說，在這個政府任內尤其如此。

Yeah. I agree, Dave. And I think the point about potential government stockpiling on these, one of the things that's working in our favor is that ibezapolstat and pol IIIC in general are very stable over time. Our ibezapolstat API, right now, we have about 48 months stability and probably close to five years, sorry, 48 months and closer to five years stability and similar length stability in packaged form. So that makes it prime for stockpiling.

是的。我同意，Dave。另外關於政府可能對這些產品進行儲備的一點，我們的一個優勢是 ibezapolstat 以及一般的 pol IIIC 隨時間非常穩定。我們的 ibezapolstat 原料藥（API）目前大約有 48 個月的穩定性，且可能接近五年——抱歉，是 48 個月、接近五年的穩定性；而在包裝形式下也有類似時長的穩定性。因此非常適合用於儲備。

Yeah. Jason, I'd just like to add one other little one for you in one of my conversations on Capitol Hill, I heard from a former Navy pilot that MRSA is kind of burgeoning greatly in Navy ships. So the government apparently is looking for a new pipeline in that area. As you know, we have something for that.

是的。Jason，我還想再補充一點：在我於國會山莊的一次對話中，我從一位前海軍飛行員那裡聽說，MRSA 在海軍艦艇上正大幅滋長。所以政府顯然正在尋找該領域的新研發管線。如你所知，我們在那方面也有產品。

Okay.

好的。

I think that's all my questions, for now. Thank you for taking the time. Appreciate it.

我想目前就這些問題。感謝您撥冗。非常感激。

No problem. Thank you.

不客氣。謝謝。

James Molloy, AGP / Alliance Global Partners Corp

James Molloy，AGP / Alliance Global Partners Corp

Hey guys. Good morning. Thank you for taking my questions. I want to follow up on -- more on what Jason said or asked on the timing. In the March 9 press release, you said the first patient here in the Phase II fourth quarter '26. Should we understand correctly the 12 to 18 months after the fourth quarter of this year for this Phase II to fully enroll?

各位好。早安。謝謝讓我提問。我想就時間點再追問一下——更針對 Jason 剛才提到或問到的部分。在 3 月 9 日的新聞稿中，你們說第二期試驗的首位病患會在 2026 年第四季。我們是否可以正確理解為：這個第二期試驗要完成收案，會是在今年第四季之後再過 12 到 18 個月？

Yeah. So sometime in the fourth quarter, plus 12 to 15 months.

是的。也就是第四季的某個時間點，再加上 12 到 15 個月。

Okay. And then obviously, the Phase III wouldn't start until some point after that.

好的。那很明顯，第三期要到那之後的某個時間點才會開始。

Correct.

沒錯。

Is it possible for Phase III to start? Can you give interim data, and the Phase III might start if things change during that trial?

第三期有可能提前開始嗎？你們能否提供期中數據，如果在試驗期間情況有變，第三期是否可能啟動？

Can you repeat that, [Jason]?

你可以再重複一次嗎，[Jason]？

Yeah. Is there any chance of any interim data out of the Phase II that might spur the Phase III to start? Or at this point, going down this path, the Phase III (inaudible) would not start until this Phase II is done.

可以。第二期是否有機會釋出任何期中數據，進而促使第三期啟動？還是說在目前這條路徑下，第三期（聽不清）要等到第二期完成後才會開始。

Yeah. I mean it's possible, Dave or Mike, you can comment on that again, but we really would like to see the full 20 patients for decision-making and being best to size the following trial, the controlled trial. Mike or Dave?

是的。我的意思是，這是有可能的；Dave 或 Mike 你們可以再評論一下，但我們確實希望看到完整的 20 位病患資料，才能做決策，並且更好地為後續試驗、也就是對照試驗，進行規模設計。Mike 或 Dave？

It will give us confidence.

這會讓我們更有信心。

Yeah. It's a balance, but I agree with Bob. The more data we have, the more confidence we have in being able to start to size the Phase III trial. We can certainly get started with preparatory activities if we're encouraged. But as Bob said, the more data we get, the better off we'll be.

是的。這需要權衡，但我同意 Bob 的看法。我們掌握的數據越多，就越有信心開始規劃第三期試驗的規模。如果結果令人鼓舞，我們當然可以先啟動一些前置準備工作。但如 Bob 所說，數據越多，我們就越有利。

Yeah. I guess I would just like to put an asterisk on it. Understanding we ended our Phase IIa in acute CDI early and the IIb, we ended early. We're going to take a preliminary look at the first 10 patients and we'll be able to call an audible if we -- if our Scientific Advisory Board feels it's appropriate.

是的。我想我只是想加註一點。考量到我們先前在急性 CDI 的第二期 a，以及第二期 b，都曾提前結束。我們會先初步檢視前 10 位病患的結果；如果我們的科學諮詢委員會認為合適，我們也能臨機應變、調整策略。

And would that be -- would that audible happen on the first 10 patients potentially after the eight weeks? Or would you wait the full six months?

那麼——這個臨機應變，是否可能在前 10 位病患、潛在地在 8 週之後就發生？還是你們會等滿 6 個月？

Well. It would depend on what the R&D guys think. I would imagine it would be after the eight weeks because I don't think many of these programs have been evaluated for six months.

嗯。這要看研發團隊怎麼想。我猜應該會在 8 週之後，因為我認為這類計畫很少會以 6 個月來做評估。

The most important end point is eight weeks.

最重要的終點是 8 週。

Yeah.

是的。

Yeah. Okay. And then maybe may be hard to answer this one, but I know you talked about the one trial deal getting away from the two trial dogma. Speaking with a number of other companies who have gone in front of the FDA, obviously, a lot of things have been said about trying to speed things up and make some changes to the clinical trial procedure.

是的。好的。接下來這題可能比較難回答，但我知道你們談到「一項試驗」的做法，想要擺脫「兩項試驗」的教條。我也和不少其他曾經到 FDA 面前的公司聊過；顯然，外界談了很多想要加速、並對臨床試驗流程做一些改變。

But some of these other companies who spoke with have not found really much difference when they actually approach the FDA, still are facing the folks, same people beneath. How -- it maybe early to say, but how really do you think the 1 trial might be?

但我接觸的其中一些公司發現，實際去和 FDA 接洽時並沒有太大差異，底下還是同一批人、同樣的作法。這也許還太早，但你們覺得「一項試驗」真的會有多大機會落地？

Maybe I can take that one, Dave. I'm pretty encouraged that I think that is going to be a game changer here as well as a number of other things. We have -- one of our scientific advisers is Mark Goldberg, who is the former Head of the animocrobials division at the FDA. And his read on it, what has to happen next is that this needs to be formalized.

Dave，這題也許我來回答。我相當受到鼓舞，我認為這會是改變遊戲規則的一步，另外還有一些其他因素也是。我們的一位科學顧問是 Mark Goldberg，他曾任 FDA 抗微生物（animocrobials）部門主管。依他的解讀，接下來必須把這件事正式化。

So they'll probably -- and we believe they're already working on our guidance for industry to clarify some of the questions and lay down the parameters for what that would be. In our case, as I think one of -- maybe Jason mentioned this as well, too, we currently plan to do roughly 474 patients two trials, excuse me, noninferiority to Banco.

所以他們可能——而且我們相信他們已經在著手——會發布產業指引（guidance for industry），以釐清一些問題，並訂出相關參數。就我們的情況而言，正如我想其中一位——也許 Jason 也提到過——我們目前規劃大約 474 位病患、兩項試驗，抱歉，是以 Banco 為非劣性比較。

If we only have to do one trial, maybe we'll bump that up a little bit so that we cover the safety database with one trial. But we're poised and ready to talk to FDA at the appropriate time and things need to settle down before they actually get all their ducks in a row and sort of codify it. Does that help?

如果只需要做一項試驗，我們可能會把樣本數稍微提高一些，讓單一試驗就能涵蓋安全性資料庫。但我們已經準備好在適當時點與 FDA 討論；在他們把所有事情理順、並將其某種程度上編纂成規範之前，還需要一些時間讓局勢穩定下來。這樣有幫助嗎？

You know I do. Just to add on to what Bob said, looking at it from the top down, Jim, and you can see this on our website, it takes the government time, but we have time for this change to go into effect because we have the 20-patient trial in front of us.

有的。補充 Bob 的說法，Jim，從更高層次來看——你也可以在我們網站上看到——政府需要時間，但我們也有時間讓這項改變生效，因為我們眼前還有這個 20 位病患的試驗要先做。

And the paper talking about ending the two trial dogma was co-authored by Marty Makary, the head of the FDA that's on our website. It's in the New England Journal of Medicine. But certainly, if there's going to be a change in this regard, Marty Makary is the guy that you would want to see as a co-author on the paper.

而那篇談到終結「兩項試驗」教條的文章，是由 Marty Makary（FDA 負責人）共同撰寫，我們網站上也有。文章刊登在《新英格蘭醫學期刊》。但可以確定的是，如果這方面真的要有改變，Marty Makary 會是你最希望看到成為共同作者的人。

Oh no. No, I've certainly seen it. I've seen and heard a lot of talk about the changes. They do need to get their ducks in a row still. So it's a bit of a duck thing still, but I hope that certainly comes to pass.

喔不。不，我當然看過。我也看過、聽過很多關於變革的討論。他們確實還需要把事情理順。所以目前還有點像「鴨子還沒排好隊」的狀態，但我希望這件事真的能成真。

Alright. Great. Thank you for taking the questions.

好的。很好。謝謝讓我提問。

Thank you, Jim.

謝謝你，Jim。

(Operator Instructions)

（接線員指示）

We're showing no questions in the queue at this time. This concludes today's event. We'd like to thank you for your interest in Acurx Pharmaceuticals. You may disconnect your lines and enjoy your day.

目前顯示沒有提問在排隊中。今天的活動到此結束。感謝各位對 Acurx Pharmaceuticals 的關注。您可以掛斷電話，祝您有美好的一天。