Greetings, and welcome to Acurx Pharmaceuticals' conference call to discuss full year and fourth quarter 2025 financial results. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Thank you. Please go ahead.
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?
Thank you. Ladies and gentlemen, the floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star one to register a question at this time. Today's first question is coming from Jason McCarthy of Maxim Group. Please go ahead.
Good morning, guys. Thanks for taking the questions. I have a few, so if you just bear with me. Starting with the new recurrent CDI trial, for the primary endpoint, I'm assuming it's prevention of a recurrence, how far out do you have to go? Is it three months, six months, one month, and so on? And what is the cost of that trial? Bob?
Yeah. First question was how far out you mean in terms of evaluation through the endpoint? How long?
Yes, sir. Mm-hmm.
Yeah. Mike, you can take that question if you like. Just explain the treatment period as well as the follow-up period.
Sure. Thanks for the question, Michael Silverman here. Following the end of treatment, we will observe patients from cure of the disease to a first endpoint, a primary assessment endpoint of eight weeks. That's based on other products that are out there having been approved for prevention of recurrent disease. The standard there has been eight weeks. The precedent has been eight weeks. That will be our endpoint for recurrent disease. We will continue to follow patients out for approximately six months after the end of therapy to gather additional data.
Okay. Just as a follow-up to that, when you go out to six months in general, what do you see as the rate of recurrence with vanc or any other treatment that they're getting on average?
Yeah, it's a good question. Thanks. We may not have data out to six weeks on the drugs that are out there. That has not necessarily been the standard follow-up. Vancomycin, we can see rates of recurrence between 20% and 40%. You know, for the anti-recurrence therapies that are out there like Vowst and Rebyota, those recurrence rates are down in the range of 15%-30%. I'm talking about eight weeks, the label indication.
Okay, Jason?
Got it. Yes.
Good. Dave, you wanna address the
Thank you.
Dave, you wanna address the cost question?
The only thing I think we left out is the treatment period. I think there's a small modification to that, Jason.
Yeah.
Bob, do you wanna provide that?
Yeah, go ahead, Mike. The initial treatment
Sure. You may recall that in our prior trials, we've used 10-day treatment period because, again, that's been standard of practice, a standard of care for the other drugs that have improved vancomycin, fidaxomicin. For this trial, for the recurrent disease trial, we're going to a 14-day treatment period for all patients. That's based on prior work that's been done with the anti-recurrence drug with the anti-recurrence agents, longer period of treatment for the acute episode may result in a higher cure rate, which would give us a more robust sample size in which to evaluate recurrence.
Got it. The cost-ish.
Dave?
Yeah, it's in the range of $4 million-$5 million.
It's likely that the current cash balance, maybe with a little bit of a top off, gets you through this, I guess we call it a pilot study in recurrent CDI, and is that something that we could see, the start and conclusion of in 2026?
We'll certainly start enrolling in 2026 in the second half. You know, we'll see how far we get with the enrollment. We think we have some really high enrolling centers, but we wouldn't expect to be fully enrolled for about 12-15 months.
Okay.
I should add, Jason, that we also have our ELOC, right? In terms of topping off, you know, we have between $7 million and $8 million left on our ELOC.
Okay. Perfect. Then just two more quick ones, then I'll jump back. If this pilot is successful, does it change, and you're starting to think about recurrent CDI for the phase III, does that change the size, the potential size of a phase III? 'Cause if it was acute, I think it was somewhere in that 400-500 patients per trial. Two phase IIIs, I know that the narrative seems to be changing to one phase III these days. Just for recurrent CDI in general, do you need less patients to get an approval versus acute?
Thank you, Jason, for that question. Mike, you can answer that in terms of what we are projecting for the follow-on trial to the open-label. We have a range of estimates right now, but it depends upon what we see in the open-label trial. Mike?
Yeah. I'd like to emphasize what Bob said. Right now, we don't have any treatment data with ibezapolstat in this patient population, so we don't know the true effect size. We have very good estimates of the other agents that are out there, Jason, as you mentioned. We still need to gather the data on the ibezapolstat in terms of clinical cure rate and prevention of recurrence. Based on what we think are reasonable assumptions, that is going back to our phase II trial in a slightly different patient population, we're currently projecting somewhere between 360 and 400 patients for a single trial in the recurrent CDI indication.
Got it. Okay, that makes sense. Just lastly, I know you guys had mentioned U.S.-based manufacturing, which seems to be a very important issue these days with the current administration. Is that something that you're really trying to make headway with regulators on or the current administration in terms of having ibezapolstat. You could see a Pol IIIC inhibitor being used in lots of different things. Maybe it's something the government is interested in stockpiling. Dave, do you wanna just kinda opine, if you would, on that aspect of the U.S.-based manufacturing.
Yeah. I think.
Yeah.
I think you hit it pretty straight on, Jason. You know, we're continuing to have detailed discussions with government agencies, including BARDA. You know, it's important to them in their consideration of a public-private partnership that our program be made in America. That's part of what makes them excited about getting appropriate funding allocated, you know, to each sponsor that's looking for government money, as you say, these days under this administration.
Yeah. I agree, Dave. I think the point about potential government stockpiling on these, one of the things that's working in our favor is that our ibezapolstat and Pol IIIC's in general are very stable over time. Our ibezapolstat API, right now, we have about 48 months stability and probably closer to five years stability, and similar long-term stability in package form. That makes it prime for stockpiling.
Yeah, Jason.
Got it. Mm-hmm.
I'd just like to add one other little one for you. You know, in one of my conversations on Capitol Hill, I heard from a former Navy pilot that MRSA is, you know, kinda burgeoning greatly in on Navy ships. The government apparently is looking for a new pipeline in that area. As you know, we have something for that.
Yeah.
Okay. I think that's all my questions, for now. Thank you, for taking the time. Appreciate it.
No problem. Thank you.
Thank you. Our next question is coming from James Molloy of Alliance Global Partners. Please go ahead.
Hey, guys. Morning. Thank you for taking my questions. Sort of follow up on more on what Jason said or asked on the timings. In the March ninth press release, you said the first patient here in the phase II, fourth quarter 2026. So we understand correctly, it'd be 12-18 months after the fourth quarter of this year for this phase II to fully enroll?
Yeah. You know.
Yeah.
Sometime in the fourth quarter plus 12-15 months.
Okay. Obviously the phase III wouldn't start until some point after that.
Correct. Right.
It's possible the phase III could start, you can get interim data, and the phase III might start if things change during that trial.
David-
I'm sorry. Yeah, can you repeat that, Jason?
Is there any chance there can be an interim data out of the phase II that might spur the phase III to start? Or at this point, going down this path, the phase III confirmatory would not start until this phase II is done.
Yeah. I mean, it's possible. Dave or Mike, you can comment on that again, but we really would like to see the full 20 patients, you know, for decision-making and being best to size the following trial, the control trial. Mike or Dave?
Yeah. I mean,
Go ahead, Mike.
You know, give us confidence.
Yeah.
Yeah.
Yeah. It's a balance, but I agree with Bob. The more data we have, the more confidence we have in being able to start the size the phase III trial. We can certainly get started with preparatory activities if we're encouraged. As Bob said, the more data we get, the better off we'll be.
Yeah. You know, I guess I would just like to put an asterisk on it, you know, understanding we ended our phase IIa in acute CDI early and the phase IIb , we ended early. You know, we're gonna take a preliminary look at the first 10 patients and, you know, we'll be able to call an audible if we, if our scientific advisory board feels it's appropriate.
Would that auditable happen on the first 10 patients potentially after the eight weeks, or would you wait the full six months?
It would depend on what the R&D guys think. I would imagine it would be after the eight weeks, because I don't think many of these programs have been evaluated for six months.
The most important endpoint is eight weeks, Dave.
Yeah.
Yeah.
Okay. Maybe it may be hard to answer this one, but another. You talk about the one trial deal, getting away from the two-trial dogma. Speaking with a number of other companies who've gone in front of the FDA, you know, obviously a lot of things have been said about trying to speed things up and make some changes to the clinical trial procedure. Some of these other companies I've spoke with have not found really much difference when they actually approach the FDA. They still are facing the same folks beneath. How, again, it may be early to say, but how real do they think the one trial might be?
Maybe I can take that one, Dave. I'm pretty encouraged that I think that is gonna be a game changer here, as well as a number of other things. One of our scientific advisors is Mark Goldberger, who's the former head of the antimicrobials division at the FDA. You know, his read on it, what has to happen next is that this needs to be formalized. They'll probably, and we believe they're already working on a guidance for industry to clarify some of the questions and lay down the parameters for what that would be. In our case, as I think one of, maybe, Jason mentioned this as well too, we had currently planned to do a roughly 474-patient phase II trial, excuse me, non-inferiority to vanco.
If we only have to do one trial, maybe we'll bump that up a little bit so that we cover the safety database with one trial. We're poised and ready to talk to FDA at the appropriate time. Things need to settle down before they actually get all their ducks in a row and sort of codify it. Does that help?
You know, just to add on to what Bob said, you know, looking at it from the top down, Jim, and you can see this on our website, it takes the government, you know, time, but we have time, for this change to go into effect because we have the 20-patient trial in front of us. The paper talking about ending the two-trial dogma was co-authored by Marty Makary, the head of the FDA. That's on our website. It's in the New England Journal of Medicine. Certainly, if there's going to be a change in this regard, Marty Makary is the guy that you would wanna see as a co-author on the paper.
Oh, no, I've certainly seen it. I've seen it, seen him around, heard a lot of talk about the changes. They do need to get their ducks in a row still, so it's a bit of a duck thing still. I hope that certainly comes to pass.
Yeah.
All right, great. Thank you for taking the questions.
Thank you, Jim.
Thank you. Once again, ladies and gentlemen, if you do have a question, please press star one on your telephone keypad at this point in time. We'll pause a moment for any additional questions. We're showing no questions in the queue at this time. This concludes today's event. We'd like to thank you for your interest in Acurx Pharmaceuticals. You may disconnect your lines and enjoy your day.
Thank you, Donna.
Thank you, everybody.
Thank you. Be well.