Acurx Pharmaceuticals (ACXP) 2026 年第二季法說會：FDA 審查路徑與 1,070 萬美元現金

重點摘要

• Acurx Pharmaceuticals (NASDAQ: ACXP) 在 2026 年第二季結束時擁有 1,070 萬美元現金，高於 2025 年 12 月 31 日的 760 萬美元。
• 2026 年第二季淨虧損為 230 萬美元（或稀釋後每股虧損 0.53 美元），而 2025 年第二季淨虧損為 220 萬美元（或稀釋後每股虧損 1.89 美元）。
• FDA 表示，在單一第三期 IBZ-ASPIRE 試驗及其他已完成的研究之後，願意在新藥申請前（pre-NDA）會議上評估 ibezapolstat 的整體證據，特別是若療效結果強勁。
• 這項已獲得全額資金支援、包含 20 名患者且主要針對復發性難辨梭菌（C. difficile）感染的 PATHFINDER 研究，預計將於 2026 年第四季開始招募患者。
• 管理層表示，4 月公開發行募集的資金以及剩餘的股權信用額度（Equity Line of Credit）可用資金，應可資助 PATHFINDER 研究及公司營運至少一年。但啟動 ASPIRE 仍需要額外資金。
• 2026 年 8 月，FDA 條件式接受 Syfbezi 作為 ibezapolstat 的專利名稱，同時美國專利及商標局（USPTO）核發了商標核准通知。

關鍵財務數據

2026 年前六個月，研發費用從 110 萬美元升至 140 萬美元；一般及行政費用從 330 萬美元降至 260 萬美元；淨虧損從 440 萬美元（或稀釋後每股虧損 4.01 美元）收窄至 390 萬美元（或稀釋後每股虧損 1.13 美元）。

業務與營運表現

Acurx 於 2026 年 7 月與 FDA 的會議，主要討論單一第三期急性 CDI 研究是否足以支援新藥申請。該機構對在 ASPIRE、PATHFINDER 及任何其他已完成的臨床研究之後，於 pre-NDA 會議中進行進一步討論持開放態度。管理層強調，基於單一第三期試驗進行申請的可能性，將取決於強勁的療效及整體證據包。

PATHFINDER 是一項包含 20 名患者的開放標籤研究，主要針對復發性 CDI。管理層表示該試驗已獲得全額資助，並可為治療及預防復發提供支持性證據。公司已完成前期準備工作，預計於 2026 年第四季開始招募患者。

ASPIRE 規劃為一項跨國第三期非劣效性研究。西歐與東歐均在考量區域之列，但患者篩選尚未開始。公司表示擁有足夠的原料藥（API）與製劑產品用於 PATHFINDER，並已做好準備製造足夠且效期適當的供應量以用於 ASPIRE。

Acurx 亦繼續與萊頓大學醫學中心（Leiden University Medical Center）合作研究 DNA 聚合酶 III C 抑制劑。該研究包括致力於開發第一個來自耐甲氧苯金黃色葡萄球菌（MRSA）的 Pol C 與 Acurx 抑制劑複合物的 3D 結構。

公司報告擁有 6 項美國專利及 10 項國際專利，保護 ibezapolstat 及 ACX-375C 計畫的相關技術。其他國家級的申請仍在上訴或審查中。

管理層展望

管理層預計 PATHFINDER 將於 2026 年第四季開始招募患者。管理層表示，現有財務資源應能支援該研究並資助營運至少一年。

ASPIRE 的啟動仍取決於能否取得適當的公開、私人或合作夥伴資金。Acurx 表示多項融資計畫正在進行中，但未提供具體的完成時程表。

管理層還描述了 PATHFINDER 之後可能採取的替代開發途徑。若這項探索性研究順利完成，Acurx 計劃與 FDA 會面，討論是否符合《抗細菌與抗真菌藥物限制群體途徑》（LPAD）的資格。管理層表示，這可能允許在單一第三期研究支援下提交復發性 CDI 的申請，成本可能僅為 ASPIRE 試驗的大約一半。此途徑仍須經 FDA 審查。

風險與關注焦點

• 若無來自公開、私人或合作夥伴來源的額外資金，ASPIRE 即無法啟動。
• FDA 尚未承諾接受以單一第三期試驗進行新藥申請。其評估將取決於臨床證據的整體性與強健性。
• PATHFINDER 是一項包含 20 名患者的探索性、開放標籤研究，因此執行力與數據品質對於後續的監管及合作洽談至關重要。
• 國際 ASPIRE 試驗的計畫仍處於早期階段，相關國家仍在評估中，且尚未開始篩選患者。
• 隨著臨床開發支出增加，Acurx 持續報告淨虧損。

分析師問答重點

管理層表示，現有的原料藥（API）及 ibezapolstat 製劑已足夠用於 PATHFINDER。公司也已做好準備，可製造啟動 ASPIRE 所需的供應量。

關於試驗強健性，管理層強調了高品質數據、極少的計畫書違規與缺失資訊、跨終點及試驗單位的療效一致性，以及與美國臨床實踐相關的患者群體。計畫追蹤至治療後 8 週。

ASPIRE 的急性治療終點將測試相較於萬古黴素（vancomycin）的非劣效性，而非優越性。管理層表示，統計框架在信賴區間下限採用 10% 的非劣效性界限。

管理層認為 PATHFINDER 數據對潛在的合作洽談及監管規劃至關重要。成功的結果可支援更廣泛的 ASPIRE 證據包，或與 FDA 就復發性 CDI 的 LPAD 途徑進行討論。

法說會完整逐字稿

完整財報電話會議逐字稿

管理層陳述

Operator

Greetings. Welcome to Acurx Pharmaceuticals to discuss Second Quarter 2026 Financial Results on August 14, 2026 Conference Cal l and provide business update. [Operator Instructions] Please note, this conference is being recorded.

I'll now turn the conference over to Rob Shawah, Chief Financial Officer. Thank you. You may begin.

Robert Shawah

Thank you, Rob. 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 2026, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter ended June 30 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.

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, Thursday, August 13, 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. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, August 14.

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

David Luci

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter and also to hear some recent updates on our continuing progress. Then we'd be pleased to take any questions.

Our Executive Chairman, Bob DeLuccia and our Medical Director, Dr. Michael Silverman, have joined us today and will be available to answer questions about our recent FDA meeting and our clinical development plan for ibezapolstat, both in recurrent and C. diff infection and an acute CDI.

First, I'd like to briefly summarize just a few of our key activities for the second quarter of 2026 or in some cases, shortly thereafter. Last month, in July 2026, the company's research and development team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single Phase III study in acute CDI and its acceptability as a pivotal trial for filing a new drug application, the outcome of which we provided in more detail in our August 3 press release.

Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the ibezapolstat clinical development program at a pre-NDA meeting after completion of a single Phase III trial called IBZ-ASPIRE and any other clinical trials conducted prior to the pre-NDA meeting, which will include the PATHFINDER study, 20-patient open-label and recurrent CDI, particularly if the clinical efficacy results are robust.

As you may recall from our previous announcements, we've begun start-up activities to conduct the 20-patient groundbreaking PATHFINDER study in mostly recurrent CDI with enrollment anticipated to start in the fourth quarter. This trial was acknowledged by FDA as being significant and along with robust results from our ASPIRE trial will form the basis of a potential approval for the treatment of both CDI and for the treatment of CDI and prevention of recurrent CDI.

In August 2026, the company received FDA conditional acceptance and USPTO Trademark Allowance of its proprietary name or brand name for ibezapolstat which I'll share with you now is Syfbezi. These initial milestones will form the basis for the commercial identity ibezapolstat as the company prepares to advance it towards its international Phase III registration program and ultimate commercialization.

Also in July, we signed and announced last week a continuation of our scientific partnership with Leiden University Medical Center to advance development of our DNA pol III C inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received from the Dutch government in November 2025. This new partnership will enable further mechanistic research into DNA pol III C inhibition to accelerate the development of novel new antibiotics that are systemically active against a wide range of Gram-positive pathogens resistant to currently available antibiotics.

This new research also aims to generate the first-ever 3D structure of pol C from methicillin-resistant Staphylococcus aureus in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen as designated by the CDC and the FDA.

In the same month in July, a presentation of scientific data by Dr. Kevin Garey and his team from his laboratory at the University of Houston College of Pharmacy demonstrated that following treatment in a state-of-the-art laboratory model with ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence.

In addition, IBZ and fidaxomicin were superior in biofilm experimental models with IBZ significantly more effective at killing C. diff than vancomycin and fidaxomicin. Acurx prepared to commence its Phase III clinical trial program with the ASPIRE trial for the treatment of both CDI and reduction of recurrence pending appropriate funding from public or private sources or partnerships. Our recent progress and efforts to secure this funding are ongoing.

I'd also point out that our PATHFINDER trial is fully funded and if successful, will elevate the product profile of IBZ as well as provide significant supportive data for FDA's evaluation. In April, the company announced the closing of a registered direct offering of up to $7.1 million issuing 825,085 shares of our common stock or prefunded warrants at a purchase price of $3.03 per share, priced at the market under NASDAQ rules.

In addition, in a concurrent private placement, the company issued unregistered short-term warrants to purchase up to 1.65 million shares of common stock. The short-term warrants have an exercise price of $2.78 per share and are immediately exercisable upon issuance and will expire 24 months following the effective date of the registration statement -- registering a resale of the shares of common stock underlying the short-term warrants. This additional funding when coupled with the remaining availability under our Equity Line of Credit, ensures that the company has a financial resource to conduct the PATHFINDER clinical trial in recurrent C. difficile and fund operations for at least 1 year.

Also in April, a scientific poster showing that our new DNA pol III C systemically absorbed antibiotics in preclinical development to treat other Gram-positive infections, achieve potentially therapeutic plasma levels and reduce MRSA tissue burden while maintaining a higher gut microbial diversity similar to baseline and distinct from linezolid. These data were presented at the 35th Congress of ESCMID, held in Munich, Germany, Dr. Khurshida Begum, Research Scientist in the laboratory of Dr. Kevin Garey at University of Houston presented the poster entitled Preclinical microbiome evaluation of novel Pol C inhibitor compounds.

Using microbiome profiling, metagenomics, the authors concluded that DNA pol III C antibiotic compounds represent a targeted strategy to treat resistant Gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibotic-induced dysbiosis.

Commenting on the significance of this data Dr. Garey from the University of Houston stated, discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health-promoting bacteria in our gut microbiome, is the clinical holy grail of antibiotic development.

Initial works at the University of Houston with Acurx, novel pol III C inhibitors has demonstrated favorable gut microbiome [indiscernible] sparing effects. The novel findings presented at ESCMID demonstrate these positive microbiome results via class effect of DNA pol III C inhibitors potentially positioning them as unique additions to the anti-gram positive therapeutic armamentarium. So this work, coupled with our recently announced scientific partnership with Leiden University Medical Center will pave the way for further rational design of novel DNA pol III C inhibitors to expand our opportunities for lead optimization and our portfolio of groundbreaking anti-infective therapeutics.

With regard to our patents to date, Acurx has secured 6 U.S. patents and an additional 10 patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea and Mexico. All of which protect key aspects of our company's ibezapolstat and the ACX-375C program, targeting DNA pol III C. Additional country-level patent applications remain under review. Also and significantly in the first quarter, a new patent was issued related to IBZ and it's used to treat CDI while reducing the recurrence of the infection as well as improving the health of the gut microbiome. Additional country-level patent applications remain under review.

We continue to identify and pursue funding opportunities for our Phase III ASPIRE trial for the treatment of both acute CDI and a reduction of recurrence. We have several initiatives underway to this end, and we'll report our progress on future updates. As we've continually reported, IBZ's clinical and nonclinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

Furthermore, IBZ has FDA QIDP and Fast Track designations for treatment of CDI as well as SME or small and medium enterprise status in the EU. All Acurx compounds and preclinical development are FDA and Fast Track eligible, not received yet, and target positive infectious disease classified as serious threat priorities by CDC and FDA.

We remain confident that while development of IBZ competitive profile continues to evolve and strengthen, we'll continue to successfully navigate through these challenging times in our industry sector. And now back over to Rob Shawah, our CFO, to guide you through the highlights of our financial results for the second quarter of 2026. Rob?

Robert Shawah

Thanks, Dave. Our financial results for the second quarter ended June 30, 2026, were included in a press release issued earlier this morning. The company ended the quarter with cash totaling $10.7 million, compared to $7.6 million as of December 31, 2025. During the quarter, the company raised a total of approximately $2.5 million of gross proceeds through a Registered Direct Offering, as well as $0.8 million under the Equity Line of Credit.

Research and development expenses for the 3 months ended June 30, 2026, were $1.1 million compared to $0.5 million for the 3 months ended June 30, 2025, an increase of $0.6 million. The increase was due primarily to an increase in manufacturing costs of $0.3 million, and an increase in consulting costs of $0.3 million as a result of costs associated with the new recurrent CDI trial program.

For the 6 months ended June 30, Research and development expenses were $1.4 million compared to $1.1 million for the 6 months ended June 30, 2025. The $0.3 million increase was due primarily to a $0.1 million increase in consulting fees and a $0.2 million increase in manufacturing costs as a result of costs associated with the new recurrent CDI trial program.

General and administrative expenses for the 3 months ended June 30 were $1.2 million compared to $1.7 million for the 3 months ended June 30, 2025, a decrease of $0.5 million. The decrease was primarily due to a $0.3 million decrease in professional fees, a $0.1 million decrease in legal costs and a $0.1 million decrease in share-based compensation expense.

For the 6 months ended June 30, general and administrative expenses were $2.6 million that was compared to $3.3 million for the 6 months ended June 30, 2025, a decrease of $0.7 million. The decrease was due primarily to a $0.3 million decrease in professional fees, a $0.2 million decrease in legal costs, and a $0.2 million decrease in share-based compensation expense.

The company reported a net loss of $2.3 million or $0.53 per diluted share for the 3 months ended June 30, 2026 that was compared to a net loss of $2.2 million or $1.89 per diluted share for the 3 months ended June 30, 2025. For the 6 months ended June 30, the company reported a net loss of $3.9 million or $1.13 per diluted share. That was compared to a net loss of $4.4 million or $4.01 per diluted share for the 6 months ended June 30, 2025, all for the reasons previously mentioned. The company had 4,683,253 shares outstanding as of June 30, 2026.

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

David Luci

Thanks, Rob, and to all of you for joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to the call our Medical Director, Dr. Michael Silverman and our Executive Chairman, Bob DeLuccia to assist with Q&A regarding our recent FDA meeting and our ibezapolstat clinical development program.

And now back to the operator to open the call for questions. Operator?

Operator

[Operator Instructions]

We'll move on to our question will be from Matthew Keller of H.C. Wainwright.

分析師問答

Matthew Keller

So my first one related to manufacturing. I was wondering, do you have enough API for the planned upcoming trials? And I guess, where do you stand or where do you stand potentially on manufacturing ibezapolstat?

David Luci

Thank you, Matt. Bob, would you like to...

Robert DeLuccia

We stand on -- and we have plenty of API and also the formulated product is all ready to go to support the PATHFINDER trial, and we're poised to have enough API manufacturing with appropriate dating to start the ibezapolstat ASPIRE trial as well.

Matthew Keller

Perfect. And then a second question, if I may -- go ahead, sorry.

Robert DeLuccia

Yes. No, I want to make sure that answered your question.

Matthew Keller

Yes, yes. And the second question, I guess, if I may. Again, you guided that the ASPIRE trial will be international trial. I was wondering what geographies you guys are considering and if you've begun sort of activities in those regions for that trial?

Robert DeLuccia

I can answer that as well, too. Mike, are you on the line, you can join in just to give an idea of the scope of the trial internationally.

Michael Silverman

Well, the plans in international. I don't have my finger on the pulse of every country that we've considered, but certainly Western and Eastern Europe. Bob, please expand if you can.

Robert DeLuccia

Yes, we can follow up with the details of the countries, but we haven't begun screening for that yet, but it will be all inclusive of those countries that we know have generally high incidence of C. difficile infection obviously.

Operator

[Operator Instructions] Our next question is from the line of James Molloy of Alliance Global Partners.

James Molloy

On the -- one of the things you guys highlighted on the August 3, you touched on the FDA is also may -- if the data is robust enough, it may give you induction as well as maintenance of remission is can you walk through sort of what constitutes reduction of remission? What constitutes the robust enough data? I know the FDA won't guide to that exactly. But in your mind, what gives you guys coming out of the PATHFINDER trial and going into ASPIRE? What are you sort of -- what's your target to -- can talk about sort of the FDA's interactions regarding that, please?

Robert DeLuccia

This is Bob. I'll let Mike join in. At the meeting, we laid out the parameters as to what would constitute robust. And Mike, do you want to go over those.

Michael Silverman

Yes. Thanks for the question. As you say, it's not something that can be specifically prescribed. But as Bob said, we proposed a number of potential criteria based on good clinical practices and also various FDA guidances. I like to think about it, the support of robustness in 2 general categories. One is what are these items that we would naturally build into a clinical trial, good clinical practive, high-quality data, minimization of protocol violations, minimization of missing data, those sorts of things to ensure that the data are trustworthy.

The second bucket of activities -- your second bucket of criteria would be those things that are inherent in drug, consistency of efficacy data across all of our endpoints, across all of our trial sites, across all of our countries. And I think this goes back to the previous question. We also need to ensure that our patient population is representative of the kinds of patients we've seen in the United States. So we do an international trial. We have to have an eye on clinical practice and clinical guidelines that are applicable in the United States. Those are the sorts of things that we're building in this trial. I hope that helps.

Robert DeLuccia

Yes. Just to build on that a little bit. Thank you, Mike and Bob. One of the features of this new ASPIRE trial design is to measure the patients an extraordinary amount of time after the end of treatment, 8 weeks after the end of treatment, which we don't know that that's been done before, but I think that also speaks to the robustness of the data. So if you're seeing no reinfection 8 weeks after the end of treatment and patient population that's had 3 or more prior episodes in the past year, we think the FDA will find that to be persuasive.

James Molloy

I guess, what's sort of the bogey with vanco that you're trying to beat assuming you do have some, of course, but how much better than vanco do you think the FDA will say that's robust?

Michael Silverman

Yes. In terms of -- it's another good point in statistical significance of the results. This is not a superiority trial. This is a noninferiority trial. So we don't have to show superiority over vancomycin for the clinical care acute treatment endpoint. We need to show noninferiority within standard bonds, which is a statistical concept but the lower limit would be confidence interval within 10%. That's a non-inferiority approach.

James Molloy

Excellent. And then maybe a final question for me would be, I know that the PATHFINDER is first, you've guided to maybe a year, 1.5 years to enroll. How much is -- and before you go to the ASPIRE trial, the final potentially pivotal trial, how important is the PATHFINDER data for a potential partnership to help fund the Phase III ASPIRE trial down the road?

David Luci

We think that's quite important. And we're heartened by the FDA's enthusiasm with our being willing to conduct that trial. Now interestingly, whether or not the ASPIRE trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C diff. So if we finish the 20 patients exploratory trial, open label, that we call PATHFINDER, we will meet with the FDA, and we have the possibility to be considered an LPAD pathway program, which would make -- which will make us -- give us the ability to file for approval in recurrence C. difficile with just one Phase III trial, which may be somewhere in the neighborhood of half the price of one of the ASPIRE trials.

Operator

This now concludes our question-and-answer session. And ladies and gentlemen, this also concludes today's conference. We thank you for your participation. Have a wonderful day.

David Luci

Thank you, Rob.

Operator

Thank you.