Acurx Pharmaceuticals, Inc.

Greetings and welcome to Acurex 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 Sawa, 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 ended and fourth quarter 2025, which is available on our website at accorexpharma.com. Joining me today are Bob DeLucia, Executive Chairman of Accorex, Dr. Michael Silverman, medical director of Acorex, who will be available for questions related to our R&D activities and strategy during the Q&A period, and David Lucci, president and CEO of Acorex, 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 questioned not to place undue reliance on these forward-looking statements, and ACREX 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 Dave Vellucci. 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. And 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 ID Week in Atlanta at the session entitled New Antimicrobials in the Pipeline. Presenting on behalf of AccuRx are Dr. Michael Silverman, our medical director, who's with us this morning, and Dr. Kevin Geary, professor and chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the Ibezopolstat clinical program. The company's presentation included an update on Ibezopolstat 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 effects of representative compounds from our DNA-PAL3C inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Gary stated, initial work on a novel lead DNA-PAL3C inhibitor compounds indicate that the positive microbiome sparing results from our abezopolistat studies may be a class effect. This is an important finding because microbiome sparing likely contributed to abezopolistat'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, linazolid, demonstrated an overabundance of uncommon and harmful gram-negative bacteria, known to contribute to recurrence of infection. Dr. Gehry further stated, these data indicate a low probability for DNA PAL3C inhibitors to increase the risk of causing a C. diff infection, mycomycin-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-PAL3C inhibitor, Ibezopulsat, bound to its target. The publication is entitled, A Unique Inhibitor Conformation Selectively Targets the DNA Glymerase PAL-C of Gram-Positive Priority Packages. This is an important milestone in AccurX'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 grand positive priority pathogens. On March 9th of 2026, We issued a press release announcing that we are launching a groundbreaking Ibenzapolistat clinical trial program in patients with recurring CDI that has the potential to shift the treatment paradigm and prevention of R-CDI from two agents to one agent. When coupled with Ibenzapolistat's phase two 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 Ivezopolistat 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 two trial, all 25 patients treated with Ivezopolistat 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. But briefly, this new clinical trial in RCDI begins with an open-label pilot trial to gain experience with Ipeza-Polstad 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 control phase three 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 three pivotal RCDI trial, And per the operative FDA procedure, the company plans to request FDA approval for treatment and prevention of R-CDI under the FDA's limited population pathway for antibacterial and antifungal drugs guidance for industry, published in 2020. Acurex's clinical program in the broader CDI patient population is ready to advance to Phase III international 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 CEI 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 Call 3C 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 IBEZA-POLSTAT, as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end and will report in future updates as appropriate. As we've continually reported, IBEZA-POLSTAT clinical and non-clinical results continue to outperform and 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, Ivesipulstat 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 I-304 status 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. And now back to our CFO, Rob Schaller, 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 $.3 million compared to $.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 are $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 $.7 million. The decrease was primarily due to a $.3 million decrease in compensation-related costs and a $.3 million decrease in professional fees. For the 12 months ended December 31, 2025, general 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 $.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 12 months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the 12 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 Dave.

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 Bob Velluccia, our medical director and executive chairman respectively, to assist with further explanation of our recurrent C-pip and C-O infection trial program. Bob, would you like to add any comments?

Sure. Thanks, Dave. And 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 two, as Dave said, ibizofalstat was demonstrated to be highly effective in both curing the acute C. diff infection and in preventing recurrence. So, 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. And such success, would shift the paradigm of treatment and prevention of our CDI from two agents to one. And 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 Ibizepolstat's competitiveness, and if approved for marketing, gives it an even more attractive value proposition in the marketplace, and which, by the way, Ibizepolstat's commercial supply chain of active pharmaceutical ingredient and packaged product will be made in America. Thanks, Dave.

Thanks, Bob. And 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 1 on your telephone keypad at this time. A confirmation tone will indicate that your line is in the question queue. You may press star 2 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'd just bear with me. Starting with the new recurrent CDI trial, for the primary endpoint for, I'm assuming, is prevention of 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.

Yeah. Mike, you can take that question if you like, just showing 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 recurrent 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. Suppressant has been eight weeks. So that will be our endpoint for recurrent disease. We will continue to follow patients out for approximately six months after the endotherapy 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 Zank or any other treatment that they're getting?

On average? Yeah, it's a good question. Thanks. We may not have data after 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%. For the anti-recurrence therapies that are out there, like valicinary biota, those recurrence rates are down in the range of 15% to 30%. And I'm talking about a label indication.

Okay, Jason?

Yes.

Good. Dave, you want to 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. Bob, do you want to provide that? Yeah.

Go ahead, Mike. The initial treatment?

Sure. You may recall that in our prior trials, we've used a 10-day treatment period because, again, that's been standard of practice, standard of care for the other drugs that have been approved, vancomycin, finaxolizum. 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 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 the cards.

And the cost-ish?

Yeah, it's in the range of $4 to $5 million.

So it's likely that the current cash balance, maybe with a little bit of a top-off, gets you through... 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, but then 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, 12 to 15 months. Okay.

Okay.

I should add, Jason, that we also have our ELOC, right? So in terms of topping off, you know, we have between 7 and 8 million left on our ELOC.

Okay, good, perfect. And then just two more quick ones, and then I'll jump back. So if this pilot is successful, does it change – and you're starting to think about recurrent CDI for the phase three, does that change the size, the potential size of a phase three? Because if it was acute, I think it was somewhere in that 400 to 500 patients per trial, two phase threes. I know that narrative seems to be changing to one phase three these days, but just for recurrent CDI in general, do you need less patients to get an approval versus acute?

Yeah. 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, right?

Yeah, I'd like to emphasize what Bob said. Right now, we don't have any treatment data as opposed to that 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. But we still need to gather the data on the Abyssal Pulse set 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.

Okay, that makes sense. And then just lastly, I know you guys, you 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 ideas. You could see a whole 3C inhibitor being used in lots of different things. Maybe it's something the government is interested in stockpiling. David, do you want to just kind of 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. And, you know, it's important to them in their consideration of a public-private partnership that our program be made in America. So 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. And I think the point about potential government stockpiling on these, one of the things that's working in our favor is that, I suppose that, and policy threes in general are very stable over time. All right, I suppose that API, you know, Right now, we have about 48 months stability and probably close to five years, sorry, 48 months and closer to five years stability and similar length stability in package form. So, that makes it prime for stock bombing.

Yeah, Jason, I'd just like to have 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, kind of burgeoning greatly on Navy ships. So the government apparently is looking for new pipelines in that area. As you know, we have something for that.

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 Maboy of Alliance Global Partners. Please go ahead.

Hey, guys. Good morning. Thank you for taking my questions. To follow up on more on what Jason said, I asked on the timings. In the March 9th press release, you said the First patient here in the phase two, fourth quarter 26. Should we take regularly 12 to 18 months after the fourth quarter of this year for this phase two to fully enroll?

Yeah, you know, so sometime in the fourth quarter plus 12 to 15 months.

Okay. And then obviously the phase three, wouldn't start until some point after that. Correct. Or if possible, phase two could start, you could get interim data and the phase three might start and things change during that trial.

Can you repeat that, Jason?

Is there any chance of any interim data out of the phase two that might spur the phase three to start or at this point going down this path, the phase three, the firm trial would not start until this phase two is done.

Yeah. I mean, it's possible, Dave and 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.

He was confident.

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 size the Phase III trial. We can certainly get started with preparatory activities if we're encouraged. But 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 and acute CDI early, and the 2B, we ended early, you know, we're going to take a preliminary look at the first 10 patients and, you know, we'll be able to call an audible if our scientific advisory board feels it's appropriate.

Would that audible happen on the first 10 patients potentially after the eight weeks or would you wait the full six months?

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.

OK. And then maybe it'd be hard to answer this one, but 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, a lot of things have been said about trying to speed things up and make some changes to the clinical trial procedure. But some of these other companies I've spoken with have not found really much difference when they actually approach the FDA. They still are facing the folks, same people beneath. It may be early to say, but how real do you think the one trial might be?

Maybe I can take that one, Dave. I'm pretty encouraged that I think that is going to be a game changer here, as well as a number of other things. One of our scientific advisors is Mark Goldberger, who is the former head of the antimicrobials division at the FDA. And, you know, his read on it, what has to happen next is that this needs to be formalized. So 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 currently plan to do a 470, roughly 474 patient, one trial, two trials, excuse me, non-inferiority to Banco. 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, but 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?

Just to add on to what Bob said, looking at it from the top down, Jim, and you can see this on our website, it takes the government time, but we have time, for this change to go into effect because we have the 20-patient trial in front of us. And the paper tells me about ending the two-trial dogma was co-authored by Marty McCary, the head of the FDA. That's on our website. It's in the New England Journal of Medicine. But certainly, if there's going to be a change in this regard, Marty McCary is the guy that you would want to see as a co-author on the paper.

Well, no, I've certainly seen it. I've seen it. I've 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. But I hope that certainly comes to pass. 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 1 on your telephone keypad at this 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