Acurx Pharmaceuticals (ACXP) 2026年第二季度业绩电话会：FDA路径及1070万美元现金

核心要点

• Acurx Pharmaceuticals (NASDAQ: ACXP) 在 2026 年第二季度末拥有 1070 万美元现金，高于 2025 年 12 月 31 日的 760 万美元。
• 2026 年第二季度净亏损为 230 万美元，即稀释后每股亏损 0.53 美元；而 2025 年第二季度净亏损为 220 万美元，即稀释后每股亏损 1.89 美元。
• 美国食品药品监督管理局（FDA）表示，在完成单项 III 期 IBZ-ASPIRE 试验和其他已完成的研究后，若疗效结果表现强劲，其愿意在 NDA（新药申请）前会议上评估 ibezapolstat 的总体证据。
• 这项获得全额资助、包含 20 名主要为复发性艰难梭菌感染患者的 PATHFINDER 研究预计将于 2026 年第四季度开始招募受试者。
• 管理层表示，4 月份发行取得的融资以及剩余的股权信用额度应能为 PATHFINDER 研究和公司运营提供至少一年的资金支持。要启动 ASPIRE 试验，仍需要额外资金。
• 2026 年 8 月，FDA 条件性接受 Syfbezi 作为 ibezapolstat 的专有名称，同时美国专利商标局（USPTO）授予了商标许可。

关键财务数据

2026 年前六个月，研发费用从 110 万美元增至 140 万美元；一般及行政费用从 330 万美元降至 260 万美元；净亏损从 440 万美元（即稀释后每股亏损 4.01 美元）收窄至 390 万美元（即稀释后每股亏损 1.13 美元）。

业务与运营表现

Acurx 于 2026 年 7 月与 FDA 召开会议，重点讨论单项 III 期急性 CDI 研究是否能够支持新药申请（NDA）。FDA 对在 ASPIRE、PATHFINDER 以及任何其他已完成的临床研究结束后，于 NDA 前会议上进行进一步讨论持开放态度。管理层强调，基于单项 III 期试验进行申报的可能性取决于强劲的疗效和整体证据包。

PATHFINDER 是一项包含 20 名受试者的开放标签研究，主要针对复发性 CDI。管理层表示，该试验已获得全额资助，可为治疗和预防复发提供支持性证据。公司已完成前期筹备工作，预计将于 2026 年第四季度开始招募患者。

ASPIRE 计划作为一项国际 III 期非劣效性研究。西欧和东欧属于正在考量的地区，但患者筛选尚未开始。公司表示，其拥有足够的活性药物成分（API）和制剂产品用于 PATHFINDER，并有能力为 ASPIRE 生产足够保质期合规的供应物资。

Acurx 还继续与莱顿大学医学中心合作研究 DNA 聚合酶 III C 抑制剂。该研究包括致力于开发耐甲氧西林金黄色葡萄球菌 Pol C 与 Acurx 抑制剂复合物的首个 3D 结构。

该公司报告称拥有 6 项美国专利和 10 项国际专利，用于保护 ibezapolstat 和 ACX-375C 项目的相关领域。其他国家层面的申请仍在审查中。

管理层展望

管理层预计 PATHFINDER 的患者招募将于 2026 年第四季度开始。管理层表示，现有的财务资源应能支持该项研究，并为公司运营提供至少一年的资金。

ASPIRE 的启动仍取决于获得适当的公共、私人或合作资金。Acurx 表示，多项融资举措正在推进中，但未提供具体的完成时间表。

管理层还阐述了 PATHFINDER 之后可能采取的替代开发路径。如果该探索性研究成功完成，Acurx 计划与 FDA 就抗细菌药和抗真菌药有限群体途径（LPAD）下的潜在资格进行会晤。管理层表示，这可能允许在仅由一项 III 期研究支持的情况下提交复发性 CDI 申请，费用可能仅为 ASPIRE 试验的一半左右。该途径仍需等待 FDA 的审查。

风险与关注焦点

• 在没有获得来自公共、私人或合作方渠道的额外资金之前，ASPIRE 无法启动。
• FDA 尚未承诺接受单项 III 期试验用于 NDA 申请。其评估将取决于临床证据的完整性和强劲程度。
• PATHFINDER 是一项仅包含 20 名患者的探索性开放标签研究，因此其执行情况和数据质量对后续的监管及合作洽谈至关重要。
• 国际 ASPIRE 试验的计划仍处于早期阶段，相关国家仍在评估中，患者筛选尚未开始。
• 随着临床开发支出的增加，Acurx 继续报告净亏损。

分析师问答亮点

管理层表示，现有的 API 和 ibezapolstat 制剂足以满足 PATHFINDER 的需求。公司也已准备好生产启动 ASPIRE 所需的供应物资。

关于试验的强劲程度，管理层强调了高质量的数据、极少的方案违背和缺失信息、各终点和中心之间一致的疗效，以及与美国临床实践高度相关的患者人群。随访计划持续至治疗后八周。

ASPIRE 的急性治疗终点将测试相对于万古霉素（vancomycin）的非劣效性，而非优效性。管理层表示，统计框架对置信区间下限采用了 10% 的非劣效性界值。

管理层认为 PATHFINDER 的数据对潜在的合作洽谈和监管规划至关重要。成功的结果可为更广泛的 ASPIRE 证据包提供支持，或用于与 FDA 就复发性 CDI 的 LPAD 途径进行讨论。

业绩电话会议完整文字记录

完整财报电话会议逐字稿

管理层陈述

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.

分析师问答

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.