Acurx Pharmaceuticals Q2 2026 Earnings Call Transcript

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August 14, 2026

Key Takeaways

  • Positive Sentiment: FDA guidance supports a potential approval pathway for ibezapolstat through the planned single Phase III IBZ-ASPIRE trial, provided the overall clinical evidence is robust; the FDA may also consider data from the 20-patient PATHFINDER study at a pre-NDA meeting.
  • Positive Sentiment: The fully funded PATHFINDER trial in recurrent C. difficile infection is expected to begin enrollment in the fourth quarter of 2026, and management said it has sufficient API and formulated product to support both PATHFINDER and a future ASPIRE trial.
  • Negative Sentiment: Acurx still needs public or private funding, partnerships, or other financing to launch ASPIRE, an international Phase III trial. The company raised capital through stock and warrant offerings, which provided resources for at least a year but created potential dilution.
  • Neutral Sentiment: Second-quarter cash was $10.7 million, while the company reported a $2.3 million quarterly net loss; R&D spending increased to $1.1 million as manufacturing and recurrent-CDI trial costs rose, partly offset by lower general and administrative expenses.
  • Positive Sentiment: Acurx received conditional FDA acceptance and USPTO trademark allowance for ibezapolstat’s proposed brand name, Syfbezi, and reported additional patent, microbiome, and DNA Pol IIIC research progress that could support the drug’s commercial and broader antibiotic pipeline potential.
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Earnings Conference Call
Acurx Pharmaceuticals Q2 2026
00:00 / 00:00

There are 7 speakers on the call.

Operator

Greetings. Welcome to Acurx Pharmaceuticals to discuss second quarter 2026 financial results on August 14, 2026, conference call and provide business update. This time, all participants will be in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance today, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Rob Shawah, Chief Financial Officer. Thank you. You may begin.

Speaker 1

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 P. Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I will 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 will 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.

Speaker 1

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 is accurate only as of the date of this live broadcast, today, August 14. I will now turn the call over to Dave P. Luci. Dave?

Speaker 2

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 would be pleased to take any questions. Our Executive Chairman, Robert J. 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 C. diff infection and in acute CDI. First, I would like to briefly summarize just a few of our key activities for the second quarter of 2026, or in some cases, shortly thereafter.

Speaker 2

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 more detail in our August 3rd 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 patients open label in recurrent CDI, particularly if the clinical efficacy results are robust.

Speaker 2

As you may recall from our previous announcements, we've begun startup 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 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 of ibezapolstat as the company prepares to advance it toward its international phase III registration program and ultimate commercialization.

Speaker 2

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 IIIC 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 IIIC 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 PolC 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.

Speaker 2

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 his 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, ibezapolstat and fidaxomicin were superior in biofilm experimental models, with ibezapolstat significantly more effective at killing C. diff than vancomycin and fidaxomicin. Acurx remains 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.

Speaker 2

I'd also point out that our PATHFINDER trial is fully funded and, if successful, will elevate the product profile of ibezapolstat, 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 pre-funded 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 resale of the shares of common stock underlying the short-term warrants.

Speaker 2

This additional funding, when coupled with the remaining availability under our equity line of credit, ensures that the company has the financial resource to conduct the PATHFINDER clinical trial in recurrent C. diff and fund operations for at least one year. Also in April, a scientific poster showing that our new DNA Pol IIIC systemically absorbed antibiotics in preclinical development to treat other gram-positive infections, achieved potentially therapeutic plasma levels and reduced 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.

Speaker 2

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 PolC Inhibitor Compounds." Using microbiome profiling metagenomics, the authors concluded that DNA Pol IIIC antibiotic compounds represent a targeted strategy to treat resistant gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic-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, quote-unquote, 'holy grail of antibiotic development.' Initial work at the University of Houston with Acurx novel Pol IIIC inhibitors has demonstrated favorable gut microbiome-sparing effects.

Speaker 2

The novel findings presented at ESCMID demonstrate these positive microbiome results to be a class effect of DNA Pol IIIC inhibitors, potentially positioning them as unique additions to the anti-gram positive therapeutic armamentarium." 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 IIIC inhibitors to expand our opportunities for lead optimization in our portfolio of groundbreaking anti-infective therapeutics. With regard to our patent estate, to date, Acurx has secured six 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 IIIC. Additional country-level patent applications remain under review.

Speaker 2

Also, and significantly, in the first quarter, a new patent was issued relating to ibezapolstat and its use 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 IBZ-ASPIRE trial for the treatment of both acute CDI and a reduction of recurrence. We have several initiatives underway to this end, and we will report our progress in future updates. As we have continually reported, ibezapolstat clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by Clostridioides 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.

Speaker 2

Furthermore, ibezapolstat has FDA QIDP and Fast Track designations for treatment of CDI, as well as SME, or small and medium enterprise status in the E.U. All Acurx compounds in preclinical development are FDA and Fast Track eligible, not received yet, and target gram-positive infectious disease classified as serious threat priorities by CDC and FDA. We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to successfully navigate through these challenging times in our industry sector. 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?

Speaker 1

Thanks, Dave. Our financial results for the second quarter ended June 30th, 2026, were included in our 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 three months ended June 30th, 2026, were $1.1 million, compared to $0.5 million for the three months ended June 30th, 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.

Speaker 1

For the six months ended June 30th, research and development expenses are $1.4 million, compared to $1.1 million for the six months ended June 30th, 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 three months ended June 30th were $1.2 million, compared to $1.7 million for the three months ended June 30th, 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 six months ended June 30th, general and administrative expenses were $2.6 million.

Speaker 1

That was compared to $3.3 million for the six 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 three months ended June 30, 2026. That was compared to a net loss of $2.2 million, or $1.89 per diluted share for the three months ended June 30, 2025. For the six 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 six months ended June 30, 2025, all for the reasons previously mentioned.

Speaker 1

The company had 4,683,253 shares outstanding as of June 30, 2026. With that, I'll turn the call back over to Dave.

Speaker 2

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. Now back to the operator to open the call for questions. Operator?

Operator

Thank you. We'll now be conducting our question and answer session. If you'd like to ask a question at this time, you may press star one from your telephone keypad and a confirmation tone will indicate your line in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Thank you. Our first question is from the line of Radhika Siripali with S&P. Please proceed with your question. Radhika, your line is open for a question. It seems like we've lost connection with Radhika. We'll move on to our next question, will be from Matthew Keller of H.C. Wainwright. Please proceed with your questions.

Speaker 3

Hey, good morning. Thanks for taking our questions. My first one, related to manufacturing. I was wondering, do you have enough API for the planned upcoming trials? I guess, where do you stand, or where do you stand potentially on manufacturing ibezapolstat?

Speaker 2

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

Speaker 4

Yeah

Speaker 2

respond to that?

Speaker 4

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

Speaker 3

Perfect. Then a second question, if I may. Oh, sorry.

Speaker 4

Yep. I want to make sure that answered your question.

Speaker 3

Oh, yeah. The second question, I guess, if I may, again, you guided that the IBZ-ASPIRE trial will be an 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.

Speaker 4

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

Speaker 5

Well, the plans are international. I do not have my finger on the pulse of every country that we have considered, but certainly Western and Eastern Europe. I do not know. Bob, please expand if you can.

Speaker 4

Yeah. We can follow up with the details of the countries, but we have not begun screening for that yet, but it will be all-inclusive of those countries that we know have generally high incidence of Clostridioides difficile infection, obviously.

Speaker 3

Yep. No, makes sense. Thank you very much, guys.

Speaker 4

Thank you.

Operator

As a reminder, to ask a question, you may press star one. Our next question is from the line of James Molloy of Alliance Global Partners. Please proceed with your question.

Speaker 2

Good morning, James.

Speaker 6

Good morning. Thank you very much for taking my question. One of the things you guys highlighted on August 3, you touched on the FDA, if the data is robust enough, may give you induction as well as a maintenance of remission. Can you walk through what constitutes a reduction of remission? What constitutes 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 IBZ-PATHFINDER trial and going into IBZ-ASPIRE, what's your target? Talk about the FDA interactions regarding that, please.

Speaker 4

Yeah. 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, you want to go over those?

Speaker 5

Yeah. Thanks for the question. As you say, it's not something that can be specifically prescribed. 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 the support of the robustness in two general categories. One are those items that we would naturally build into a clinical trial, good clinical practice, 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 the 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 gets back to the previous question.

Speaker 5

We also need to ensure that our patient population is representative of the kinds of patients we would see in the U.S., so we do an international trial. We have to have an eye on clinical practice and clinical guidelines that are applicable in the U.S. Those are the sorts of things that we're building into this trial. I hope that helps.

Speaker 2

Yeah, just to build on that a little bit, thank you, Mike and Bob. One of the features of this new IBZ-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. If you're seeing no reinfection 8 weeks after the end of treatment in a patient population that's had three or more prior episodes in the past year, we think the FDA will find that to be persuasive.

Speaker 6

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

Speaker 5

Yeah, it's another good point, which is the statistical significance of the results. This is not a superiority trial. This is a non-inferiority trial. We don't have to show superiority over vancomycin for the clinical cure, acute treatment endpoint. We need to show non-inferiority within standard bounds, which is a statistical concept. The lower limit would be confidence interval within 10%. That's a non-inferiority approach.

Speaker 6

Excellent. Then maybe the final question from me would be, I know that the IBZ-PATHFINDER, you've guided to maybe a year and a half to enroll. Before you go to the IBZ-ASPIRE trial, suddenly the final potentially pivotal trial, how important is the IBZ-PATHFINDER data for potential partnership to help fund the phase III IBZ-ASPIRE trial down the road?

Speaker 2

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 IBZ-ASPIRE trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C. diff. If we finish the 20-patient exploratory trial open label that we call IBZ-PATHFINDER, we will meet with the FDA, and we have the possibility to be considered an LPAD pathway program, which would give us the ability to file for approval in recurrent C. diff with just one phase III trial, which may be somewhere in the neighborhood of half the price of one of the IBZ-ASPIRE trials.

Speaker 5

Yeah. I agree with you, Dave. That's important. Very important.

Speaker 6

Okay, that is all my questions. Thank you very much.

Speaker 2

Thank you, James.

Operator

Thank you. This now concludes our question and answer session. Ladies and gentlemen, this will also conclude today's conference. We thank you for your participation. Have a wonderful day.

Speaker 2

Thank you, Rob.

Speaker 5

Thank you.

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