아커릭스 파마슈티컬스(ACXP) 2026년 2분기 실적 발표회: FDA 승인 경로 및 현금 1,070만 달러

핵심 요약

• 아큐릭스 파마슈티컬스(NASDAQ: ACXP)는 2026년 2분기말 기준 현금 1,070만 달러를 보유해 2025년 12월 31일의 760만 달러에서 증가했다.
• 2분기 순손실은 230만 달러(희석 주당순손실 0.53달러)로, 2025년 2분기의 220만 달러(희석 주당순손실 1.89달러)와 비교된다.
• FDA는 특히 효능 결과가 견고할 경우, 단일 3상 IBZ-ASPIRE 임상시험 및 완료된 기타 연구 이후 신약 허가 신청 전 미팅(pre-NDA meeting)에서 이베자폴스타트(ibezapolstat) 관련 증거 전체를 평가할 의향이 있음을 내비쳤다.
• 자금이 완비된 20명 규모의 PATHFINDER 연구는 주로 재발성 클로스트리디움 디피실 감염증(C. difficile) 환자를 대상으로 하며, 2026년 4분기에 환자 등록을 시작할 예정이다.
• 경영진은 4월 공모를 통한 자금 조달과 남은 주식 신용 한도(Equity Line of Credit) 한도액으로 PATHFINDER 및 회사 운영 자금을 최소 1년간 충당할 수 있을 것이라고 밝혔다. 다만 ASPIRE를 시작하려면 추가 자금 조달이 여전히 필요하다.
• 2026년 8월, FDA는 이베자폴스타트의 제품명으로 'Syfbezi'를 조건부 승인했으며, 미국 특허청(USPTO)은 상표 등록 결정을 내렸다.

주요 재무 데이터

2026년 상반기(6개월간) 연구개발비는 110만 달러에서 140만 달러로 증가했다. 일반관리비는 330만 달러에서 260만 달러로 감소했다. 순손실은 440만 달러(희석 주당순손실 4.01달러)에서 390만 달러(희석 주당순손실 1.13달러)로 축소됐다.

사업 및 영업 실적

2026년 7월에 열린 아큐릭스와 FDA의 미팅은 단일 3상 급성 CDI 연구가 신약 허가 신청(NDA)을 뒷받침할 수 있는지 여부에 초점을 맞췄다. FDA는 ASPIRE, PATHFINDER 및 완료된 기타 임상 연구 이후 pre-NDA 미팅에서 추가 논의를 진행할 수 있다는 입장을 유지했다. 경영진은 단일 3상 임상시험을 바탕으로 한 허가 신청 가능성은 견고한 효능과 전반적인 증거 패키지에 달렸다고 강조했다.

PATHFINDER는 주로 재발성 CDI에 초점을 맞춘 20명 규모의 오픈라벨 연구다. 경영진은 이 임상시험에 자금이 완비되어 있으며, 치료와 재발 방지 모두에 대한 보조적 증거를 제공할 수 있다고 밝혔다. 회사는 개시 준비 활동을 완료했으며 2026년 4분기에 환자 등록이 시작될 것으로 예상하고 있다.

ASPIRE는 국제 3상 비열등성 연구로 계획되어 있다. 서유럽과 동유럽 등이 검토 중인 지역에 포함되지만, 환자 선별은 아직 시작되지 않았다. 회사는 PATHFINDER에 필요한 원료의약품(API)과 제형화된 제품을 충분히 확보하고 있으며, ASPIRE를 위해 적절한 유효기간을 가진 충분한 공급량을 제조할 준비가 되어 있다고 설명했다.

아큐릭스는 또한 라이덴 대학교 메디컬 센터(Leiden University Medical Center)와의 협력을 지속하여 DNA 중합효소 III C(Pol C) 억제제를 연구하고 있다. 이 연구에는 아큐릭스의 억제제와 결합된 메티실린 내성 황색포도상구균의 Pol C 최초 3D 구조를 개발하기 위한 노력이 포함된다.

회사는 이베자폴스타트 및 ACX-375C 프로그램의 다양한 측면을 보호하는 미국 특허 6건과 국제 특허 10건을 보유하고 있다고 보고했다. 추가적인 국가별 출원은 심사 중이다.

경영진 전망

경영진은 PATHFINDER 환자 등록이 2026년 4분기에 시작될 것으로 예상하고 있다. 기존 재정 자원으로 해당 연구를 지원하고 최소 1년간 회사 운영 자금을 충당할 수 있을 것이라고 밝혔다.

ASPIRE의 개시는 적절한 공공, 민간 또는 파트너십 자금 조달을 전제로 한다. 아큐릭스는 여러 자금 조달 방안이 진행 중이지만 구체적인 완료 일정은 제시하지 않았다.

경영진은 또한 PATHFINDER 이후의 대안적 개발 경로 가능성을 설명했다. 탐색적 연구가 성공적으로 완료되면, 아큐릭스는 항균 및 항진균제 제한적 환자군 경로(LPAD)에 따른 잠재적 자격에 대해 FDA와 미팅을 가질 계획이다. 경영진은 이를 통해 단일 3상 연구로 뒷받침되는 재발성 CDI 허가 신청이 가능해질 수 있으며, 비용은 ASPIRE 임상의 약 절반 수준이 될 수 있다고 밝혔다. 이 경로는 여전히 FDA의 검토 대상이다.

위험 요인 및 주시할 점

• ASPIRE는 공공, 민간 또는 파트너십 출처의 추가 자금 없이 시작될 수 없다.
• FDA는 신약 허가 신청(NDA)에 대해 단일 3상 임상시험을 승인하겠다고 약속하지 않았다. FDA의 평가 여부는 임상 증거의 전체성과 견고성에 달릴 것이다.
• PATHFINDER는 20명의 환자를 대상으로 하는 탐색적 오픈라벨 연구이므로, 향후 규제 당국 및 파트너십 논의를 위해 수행 과정과 데이터 품질이 중요하다.
• 국제 ASPIRE 임상시험 계획은 아직 초기 단계에 있으며, 대상 국가에 대한 평가가 계속되고 있고 환자 선별은 아직 시작되지 않았다.
• 아큐릭스는 임상 개발 지출이 증가함에 따라 계속해서 순손실을 기록하고 있다.

애널리스트 Q&A 주요 내용

경영진은 사용 가능한 원료의약품(API) 및 제형화된 이베자폴스타트가 PATHFINDER에 충분하다고 밝혔다. 또한 회사는 ASPIRE 개시에 필요한 물량을 제조할 준비가 되어 있다.

임상시험의 견고성과 관련하여 경영진은 고품질 데이터, 제한적인 프로토콜 위반 및 누락 정보, 평가지표 및 기관 전반에 걸친 일관된 효능, 미국 임상 현장에 부합하는 환자군을 강조했다. 추적 관찰은 치료 후 8주 동안 진행될 예정이다.

ASPIRE의 급성 치료 평가지표는 우월성이 아닌 반코마이신(vancomycin) 대비 비열등성을 평가할 예정이다. 경영진은 통계적 틀이 신뢰구간 하한선에 대해 10%의 비열등성 마진을 사용한다고 밝혔다.

경영진은 PATHFINDER 데이터를 잠재적 파트너십 논의 및 규제 계획에 중요한 것으로 판단한다. 성공적인 결과는 더 광범위한 ASPIRE 증거 패키지나 재발성 CDI에 대한 LPAD 경로와 관련해 FDA와 진행할 논의를 뒷받침할 수 있다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.