Acurx Pharmaceuticals, Inc. Common Stock 2026 Q2 Earnings Call

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.

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? 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.