Acurx Pharmaceuticals, Inc. Q4 2025 earnings call

Thank you, Donna. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the year and fourth quarter 2025, which is available on our website at acurxpharma.com. Joining me today are Robert DeLuccia, Executive Chairman of Acurx, Dr. Michael Silverman, Medical Director of Acurx, who will be available for questions related to our R&D activities and strategy during the Q&A period, and David 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 year and fourth quarter ended December 31, 2025, 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 annual report on Form 10-K, which we filed yesterday, Thursday, March 12, 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, March 13, 2026. I'll now turn the call over to David Luci. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and year ended December 31, 2025, and also to hear some recent updates, which we're excited about. We'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the fourth quarter of 2025, or in some cases, shortly thereafter. First, in October, the company received gross proceeds from the execution of 170,000 Series F Warrants of approximately $1.4 million. Also, in October, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline.

Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, who's with us this morning, and Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the ibezapolstat clinical program. The company's presentation included an update on ibezapolstat and its microbiome-sparing properties. Also presented were new colonic microbiome data from a state-of-the-art mouse infection model showing the potential microbiome-sparing class effect of representative compounds from our DNA Pol IIIc inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Garey stated, "Initial work on the novel lead DNA Pol IIIc inhibitor compounds indicate that the positive microbiome sparing results from our ibezapolstat studies may be a class effect.

This is an important finding because microbiome sparing likely contributed to ibezapolstat's sustained efficacy in the phase II trial for C. diff infection, where no patient cured of CDI experienced a recurrence. In our recent experiments, mice given the comparator antibiotic, linezolid, demonstrated an overabundance of uncommon and harmful Gram-negative bacteria known to contribute to recurrence of infection. Dr. Gary further stated, "These data indicate a low probability for DNA Pol IIIc inhibitors to increase the risk of causing a C. diff infection, vancomycin-resistant Enterococcus, or other gut microbiome-related infections." In November, the company announced that the Nature Communications scientific journal published results from its scientific collaboration with Leiden University Medical Center, demonstrating structural biology research that reveals for the first time a DNA Pol IIIc inhibitor, ibezapolstat, bound to its target.

The publication is entitled "A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase Pol IIIC of Gram-Positive Priority Pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with Leiden University Medical Center in Holland, in advancing development of these new to nature compounds, fortifying the foundation for the rational development of this innovative class of antimicrobials against other Gram-positive priority pathogens. On March 9, 2026, we issued a press release announcing that we are launching a groundbreaking ibezapolstat clinical trial program in patients with recurrent CDI that has the potential to shift the treatment paradigm and prevention of rCDI from two agents to one agent.

When coupled with ibezapolstat's phase II results of being highly effective, 96% clinical cure in 26 patients in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezapolstat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of recurrent CDI. In our phase II trial, all 25 patients treated with ibezapolstat who experienced a clinical cure were free of recurrence one month after treatment, and five out of five of these patients were observed for three months after treatment, and they remained free of recurrence. During our Q&A this morning, members of our R&D team will be available to answer any questions about this new trial program.

Briefly, this new clinical trial in rCDI begins with an open-label pilot trial to gain experience with ibezapolstat in patients with multiple recurrent CDI, with at least three episodes of CDI within the past 12 months. This will inform elements of a planned active controlled phase III registration trial in the rCDI indication to be implemented following favorable results from the open-label 20-patient trial. Upon subsequent successful completion of the phase III pivotal rCDI trial and per the operative FDA procedure, the company plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs guidance for industry, published in 2020. Acurx's clinical program in the broader CDI patient population is ready to advance to phase III international pivotal clinical trials.

In this regard, we're very excited about the FDA's recent announcement, published in the New England Journal of Medicine, that a one trial requirement will be FDA's new default standard for registration. If formalized, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. In February 2026, we announced that the U.S. Patent and Trademark Office granted a new patent for our Pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under U.S. patent rules.

We continue to identify and pursue funding opportunities for our phase III clinical trial programs for ibezapolstat, as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end, and we'll report in future updates as appropriate. As we've continually reported, ibezapolstat clinical and non-clinical 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. Additionally, ibezapolstat has qualified infectious disease product and fast track designations from the FDA for the treatment of C. difficile infection, as well as SME or small and medium enterprise status in Europe.

We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the full year and fourth quarter ended December 31, 2025. Rob?

Thanks, Dave. Our financial results for the fourth quarter and year ended December 31, 2025, were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.6 million compared to $3.7 million as of December 31, 2024. During the quarter, the company raised a total of approximately $1.5 million of gross proceeds through purchases under the equity line of credit, with gross proceeds of purchases under the equity line of credit totaling approximately $4 million for the full year of 2025.

Research and development expenses for the three months ended December 31, 2025, were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million. The decrease is due primarily to a decrease in manufacturing costs of $0.2 million and a decrease in consulting costs of $0.3 million as a result of prior year trial-related expenses. For the 12 months ended December 31, 2025, research and development expenses were $1.8 million versus $5.4 million for the 12 months ended December 31, 2024.

The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing-related costs and a $1 million decrease in consulting costs, as prior year had higher expenses related to phase IIb and phase III preparation costs. General and administrative expenses for the three months ended December 31, 2025 were $1.3 million compared to $2 million for the three months ended December 31, 2024, a decrease of $0.7 million. The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees.

For the 12 months ended December 31, 2025, general and administrative expenses were $6.3 million versus $8.7 million for the 12 months ended December 31, 2024, a decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees, a $1.4 million decrease in share-based compensation, a $0.4 million decrease in compensation costs, partially offset by a $0.3 million increase in legal costs.

The company reported a net loss of $1.6 million, or $0.73 per diluted share for the three months ended December 31, 2025, compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8 million or $5.32 per diluted share for the twelve months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the twelve months ended December 31, 2024, all for the reasons previously mentioned. The company had 2,348,113 shares outstanding as of December 31, 2025.

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

Thanks, Rob, and to all of you for joining us today. Before bringing our operator, Donna, back to open the call for questions, I'm pleased to welcome to the call Michael Silverman and Robert DeLuccia, our Medical Director and Executive Chairman, respectively, to assist with further explanation of our recurrent C. diff and CDI infection trial program. Bob, would you like to add any comments?

Sure. Thanks, Dave. As you said, you know, these are very challenging times, but we think we can rise above them head on with our new clinical development plan. I think in phase II, as Dave said, ibezapolstat was demonstrated to be highly effective in both curing the acute C. diff infection and in preventing recurrence. Based on this, we believe it has the potential to be the first to demonstrate clinical success in both the treatment of the infection and the prevention of recurrent CDI. Such success would shift the paradigm of treatment and prevention of rCDI from two agents to one.

I think this would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the U.S., results in approximately 30,000 deaths, and it generates a related public health cost burden of approximately $5 billion, of which $2.8 billion is related to recurrent CDI. I also think that our new clinical program strengthens ibezapolstat's competitiveness, and if approved for marketing, gives an even more attractive value proposition in the marketplace. Which, by the way, ibezapolstat commercial supply chain of active pharmaceutical ingredient and packaged product will be made in America. Thanks, Dave.

Thanks, Bob. Now, back to Donna, our operator for today's call for questions. Donna?