Acurx Pharmaceuticals (NASDAQ:ACXP) Q4 2025 Earnings Call

0:01 Greetings, and welcome to Acurx Pharmaceuticals Conference Call to discuss Full Year and Fourth Quarter twenty twenty five Financial Results. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Salwa, 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 in fourth quarter twenty twenty five, which is available on our website at acorexpharma.com.

0:52 Joining me today are Bob DeLuccia, Executive Chairman of Acurx Doctor. Michael Silverman, Medical Director of Acurx, who will be available for questions related to our R and D activities and strategy during the Q and A period and David Lucci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights to the financials from the year and fourth quarter ended 12/31/2025, 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.

1:51 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 ks, which we filed yesterday, Thursday, 03/12/2026. 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, 03/13/2026. 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 12/31/2025, and also to hear some recent updates, which we're excited about.

2:46 Then 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 twenty twenty five, 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 $1,400,000 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 Doctor. Michael Silverman, our Medical Director, who's with us this morning, and Doctor. Kevin Gehry, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for Microbiology and Microbiome Aspects of the Ebezapolstat clinical program.

3:44 The company's presentation included an update on idezipolstat 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 POL3C inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Doctor. Gary stated, Initial work on a novel lead DNA POL3C inhibitor compounds indicate that the positive microbiome sparing results from our ibezopolostat studies may be a class effect. This is an important finding because microbiome sparing likely contributed to ibezopolostat's sustained efficacy in the phase two trial for C. Diff infection, where no patient cured of CDI experienced the recurrence.

4:44 In our recent experiments, mice given the comparator antibiotic, Linzolid, demonstrated an overabundance of uncommon and harmful gram negative bacteria known to contribute to recurrence of infection. Doctor. Gary further stated, these data indicate a low probability for DNA IL-3C inhibitors to increase the risk of causing a C. Diff infection. Mycomycin resistant enterocognis or other gut microbiome related infections. In November, the company announced that the Nature Communications Scientific Journal published results from a scientific collaboration with Leiden University Medical Center, demonstrating structural biology research that reveals for the first time a DNA polymerase inhibitor, idezipolstat, bound to its target.

5:35 The publication is entitled, A Unique Inhibitor Confirmation Selectively Targets the DNA Polymerase Policy of Gram Positive Priority Packages. 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 packages. On 03/09/2026, we issued a press release announcing that we are launching a groundbreaking ipilsenapolstat clinical trial program in patients with recurring CDI that has the potential to shift the treatment paradigm and the prevention of RCDI from two agents to one agent.

6:33 When coupled with our vezacolstats Phase II results of being highly effective ninety six percent clinical cure in twenty six patients in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezaprolstat 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 twenty five patients treated with ipazepulostat 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.

7:24 During our Q and A this morning, members of our R and 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 ipazepulstat in patients with multiple recurrent CDI with at least three episodes of CDI within the past twelve months. This will inform elements of the planned active control 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.

8:33 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 longstanding 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 COL3C inhibitors covering composition of matter and method of use.

9:30 This patent extends to December 2039, subject to extension under U. Patent rules. We continue to identify and pursue funding opportunities for our Phase III clinical trial programs for vezipolostat, as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end and will report future updates as appropriate. As we've continually reported, I don't recall that 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 categorized as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence.

10:23 Additionally, abezoprololstat 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 ifezoprololstat'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. And now back to our CFO, Rob Shala, to guide you through the highlights of our financial results for the full year and fourth quarter ended 12/31/2025.

11:09 Rob? Thanks, Dave. Our financial results for the fourth quarter and year ended 12/31/2025 were included in our press release issued earlier this morning. The company ended the year with cash totaling $7,600,000 compared to $3,700,000 as of 12/31/2024. During the quarter, the company raised a total of approximately $1,500,000 of gross proceeds through purchases under the equity line of credit. With gross proceeds of purchases under the equity line of credit totaling approximately $4,000,000 for the full year of 2025.

11:57 Research and development expenses for the three months ended 12/31/2025 were $300,000 compared to $800,000 for the three months ended 12/31/2024, a decrease of $500,000 The decrease was due primarily to a decrease in manufacturing costs of $200,000 and a decrease in consulting costs of 300,000 as a result of prior year trial related expenses. For the twelve months ended 12/31/2025, research and development expenses are $1,800,000 versus $5,400,000 for the twelve months ended 12/31/2024. The decrease of $3,600,000 was primarily due to a reduction of $2,600,000 in manufacturing related costs and a $1,000,000 decrease in consulting costs, as prior year had higher expenses related to Phase 2b and Phase three preparation costs.

13:02 General and administrative expenses for three months ended 12/31/2025 were $1,300,000 compared to $2,000,000 for three months ended 12/31/2024, a decrease of $700,000 The decrease was primarily due to a $300,000 decrease in compensation related costs and a $300,000 decrease in professional fees. For the twelve months ended 12/31/2025, general and administrative expenses were $6,300,000 versus $8,700,000 for the twelve months ended 12/31/2024, a decrease of $2,400,000 The decrease was primarily due to a $900,000 decrease in professional fees, a $1,400,000 decrease in share based compensation, a $400,000 decrease in compensation costs, partially offset by a $300,000 increase in legal costs.

14:13 The company reported a net loss of $1,600,000 or $0.73 per diluted share for the three months ended 12/31/2025 compared to a net loss of $2,800,000 or $3.29 per diluted share for the three months ended 12/31/2024 And a net loss of $8,000,000 or $5.32 per diluted share for the twelve months ended 12/31/2025 compared to a net loss of $14,100,000 or $17.45 per share for the twelve months ended 12/31/2024. All for the reasons previously mentioned. The company had 2,348,113 shares outstanding as of 12/31/2025.

15:09 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 Valucha, our Medical Director and Executive Chairman, respectively, to assist with further explanation of our recurrent C. And CO infection trial program. Bob, would you like to add any comments? Sure. Thanks, Dave. And as you said, 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, abezoprostat was demonstrated to be highly effective in both curing the acute C. Diff infection and in preventing recurrence.

16:04 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 RCDI from two agents to one. And I think this would be a game changer to the public health threat that affects approximately five hundred thousand patients with CDI each year in The US, results in approximately thirty thousand deaths, and it generates a related public health cost burden of approximately $5,000,000,000 of which $2,800,000,000 is related to recurrent CDI.

16:51 I also think that our new clinical program strengthens ibezopolstad's competitiveness and if approved for marketing, gives an even more attractive value proposition in the marketplace. And which by the way, I suppose that 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. Today's first question is coming from Jason McCarthy of Maxim Group. Please go ahead.

17:53 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 for I'm assuming it's prevention of recurrence, how far out do you have to go? Is it three months, six months, one month, and so on? And 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 explain the treatment period as well as the follow-up period.

18:39 Sure. Thanks for the question. Michael Silverman here. Following the end of treatment, will observe patients from current 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 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 bank or any other treatment that they're getting on average?

19:33 Yes, it's a good question. Thanks. We may not have data after six weeks on the drugs that are out there. That is not necessarily been the standard follow-up. Vancomycin we can see rates of recurrence between twenty percent and forty percent. For the anti recurrence therapies that are out there like Valsin Rebiotic those recurrence rates are down in the range of fifteen percent to thirty percent. And I'm talking about a weekly label indication. Okay, Jason? Yes. Good. Dave, you wanna address the court's question? The only thing I think we left out is the treatment periods.

20:19 I think there's a small modification to that, Jason. Bob, do wanna provide that? Yes, go ahead Mike. The initial treatment. Sure. You may recall that in our prior trials we've used 10 treatment period because again that's been standard of practice, standard of care for the other drugs that have improved vancomycin, fadaxolysin. For this trial, for the recurrent disease trial, we're going to a fourteen 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 higher cure rate which would give us more robust sample size in which to evaluate recurrence. And the cost ish?

21:11 Yes. It's in the range of 4,000,000 to $5,000,000 So it's likely that the current cash balance, maybe with a little bit of a top off, gets you through this, I guess, 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 twelve to fifteen months. And I should add, Jason, that we also have our e lock, right? So in terms of topping off, we have between 7,000,000 and $8,000,000 left on our e lock.

22:12 Okay, good. Perfect. And then just two more quick ones, and then I'll jump back. If 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, potential size of a Phase three because if it was acute, I think it was somewhere in that four hundred to five hundred patients per trial, two Phase 3s. 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, I think thank you, Jason for that question. Mike, you can answer that in terms of what we're 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?

23:11 Yeah, I'd like to emphasize what Bob said. Right now, we don't have any treatment data as opposed to 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 abasopulset 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 two trial in a slightly different patient population. We're currently projecting somewhere between three sixty and four hundred patients for a single trial in the recurrent CDI indication. Okay, that makes sense.

23:58 And then just lastly, I know you guys you had mentioned U. S. Based manufacturing, which is 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 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, think you hit it pretty straight on, Jason. We're continuing to have detailed discussions with government agencies, including BARDA.

24:56 And it's important to them in their consideration of a public private partnership that our program be made in America. So that 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 that's a poll stat and policy three in general are very stable over time. Our bezepulstat API, right now we have about forty eight months stability and probably close to five five years. Sorry. Forty eight months and closer to five years stability and similar length stability in package form.

25:56 So that that makes it prime for a stock bombing. Yeah. Jason Oh, that is. Mhmm. 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, kinda burgeoning greatly in on Navy ships. So the government apparently is looking for a new pipeline in that 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.

26:42 No problem. Thank you. Thank you. Our next question is coming from James Mavoie of Alliance Global Partners. Please go ahead. Hey, guys. Good morning. Thank you for taking my questions. Just want to follow-up on more on what Jason said or asked on the timings. In the March 9 press release, you said the first patient here in the Phase two, fourth quarter twenty six. Should I should we have to take regularly twelve to eighteen 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 twelve to fifteen months. Okay.

27:30 And then then, obviously, the phase three wouldn't start until some point after that. Correct. Or it's possible to say, you could get interim data in the face, you might start if things change during during that trial. I'm sorry. Can you repeat that, Jason? Is there any interim data out of the phase two that might spur the phase three to start? 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 or Mike, you comment on that again. But we really would like to see the full 20 patients for decision making and being best to size the following trial, the control trial.

28:27 Mike or Dave? Yeah, it's a bit. 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 of Phase three 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. And I guess I would just like to put an asterisk on it, understanding we ended our phase 2a in acute CDI early and the 2b we ended early, we're going to take a preliminary look at the first 10 patients and we'll be able to call an audible if we if our scientific advisory board feels it's appropriate.

29:20 Would that be would that all all will happen on the first day of patient potentially after the eight weeks or would you wait the full six months? It would depend on what this what the r and 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. Most important endpoint is eight weeks, Dave. Yeah. Yeah. Okay. And then maybe may be hard to answer this one, but I know you talked 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.

30:10 But some of these other companies we spoke with have not found really much difference when they actually approached the FDA. They still are facing the folks, same people beneath. Again, 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 gonna be a game changer here, as well as a number of other things. One of our scientific advisors is Mark Ober, who's the former head of antimicrobials division at the FDA. And 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 four seventy, roughly four seventy four patient, one trial, two trials, excuse me, non inferiority to Banco.

31:18 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. And 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 in 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 talking about ending the two trial dogma was co authored by Marty Makary, the head of the FDA.

32:08 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 Makary is the guy that you would wanna see as a co author on the paper. Oh, no. I've certainly I've certainly seen it. I've seen it seen around. 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 of a duck thing still. But, I hope that certainly comes to pass. Yeah. Alright. Great. Thank you for taking the questions. Thank you, Jim. Thank you. 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