Acurx Pharmaceuticals, Inc. ($ACXP)

Greetings, and welcome to the Acurx Pharmaceuticals First Quarter 2026 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. I'd now like to turn the call over to your host, Mr. Rob Shawah, Chief Financial Officer. Please go ahead, sir.

Thank you, Melissa. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the first quarter of 2026, which is available on our website at acurxpharma.com. Joining today is 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 financial results from the first quarter ended March 31 and then turn the call 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 quarterly report on Form 10-Q which we filed yesterday, Monday, May 11, 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, May 12, 2026. I'll now turn the call over to Dave. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the first quarter of '26 and also to hear some recent updates. Then we'd be pleased to take any questions. For the Q&A, our Executive Chairman, Bob DeLuccia and our Medical Director; Michael Silverman, have joined us today and will be available for those questions about our rCDI program or other matters. First, I'd like to briefly summarize just a few of our key activities for the first quarter of 2026 or in some cases, shortly thereafter. On March 9, '26, we issued a press release announcing that we're starting up a groundbreaking ibezapolstat clinical trial program in patients with recurrent CDI or rCDI that has the potential to shift the paradigm of treatment and prevention of recurrency from two agents to just one for ibezapolstat. When coupled with ibezapolstat Phase II results, which showed a 96% cure rate with no recurrent C. diff in 25 of 25 patients who are cured, sparing the microbiome. This new trial has the potential to position ibezapolstat to be a new standard of care as the first agent to treat both acute CDI and prevent rCDI. In the Acute CDI Phase II trial, all 25 patients 100% treated with ibez who experienced a clinical cure of CDI were free of recurrence 1-month after treatment. And very importantly, 5 of 5 of these patients who were observed for 3-months after treatment remained free of recurrence. The new clinical [indiscernible] CDI builds on ibezapolstat strength, [indiscernible] that no patients who are cured of their infection experience a recurrence. So clinicians and patients are avoiding the recurrence trap associated with currently available therapies. This new trial begins with an open-label pilot study to gain experience with ibez in patients with multiply recurrent CDI, who've had at least 3 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 finally 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 after [indiscernible] 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. Acurx clinical program in the broader acute 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 1-trial requirement will be FDA's new default standard that is for registration, if formalized, and we could talk about that in the Q&A, this would end a long-standing 2 trial-dogma but FDA's further clarification and potentially favorable implications to our clinical development program, such as the opportunity to seek marketing approval for the Acute CDI population with 1 pivotal clinical trial. On March 3, 2026, we announced that the Korean Patent Office granted a new patent, which covers DNA pol IIIC inhibitors, including compositions of matter, methods of use and pharmaceutical compositions, which further strengthened Acurx's intellectual property portfolio, and represents the most recent addition to our expanding series of granted patents in the U.S. and internationally. To date, we've secured 10 patents, including 5 U.S. patents along with patents in Israel, Japan, India, Australia and Korea, all of which protect key aspects of the company's product pipeline. Also significantly, a new patent recently issued related to ibezapolstat, and it's used to treat CDI while reducing recurrence of infection and improving the health of the gut microbiome, additional country-level patent applications remain under review. In February '26, we announced that USPTO granted a new patent for our DNA pol IIIC inhibitors covering composition of matter and method of use. This time extends to December 2039 and subject to extension under U.S. patent rules. On April 16, 2026, the company announced the closing of a registered direct offering of 825,085 of our common stock or prefunded warrants in lieu thereof at a purchase price of $3.03 per share or a prefunded warrant in lieu thereof, 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 1,650,170 shares of common stock. The short-term warrants have an exercise price of $2.78 per share and are immediately exercised upon issuance and will expire 24 months following the effective date of the registration statement, registering the resale of the shares of common stock underlying the short-term warrants. And that registration statement, I'm happy to say, is now effective. 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 exploratory clinical trial in recurrent C. difficile infection. And just last month, a scientific poster showing our new DNA pol IIIC systemically absorbed compounds in preclinical development to treat other [indiscernible] infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a high microbial diversity similar to baseline and distinct from linezolid. This poster was presented at the 35th Congress of Estimated Global, the European Society of Clinical Microbiology and Infectious Disease, Annual Scientific Conference, held in Munich, Germany from April 17 to April 21. Dr. Khurshida Begum, Research Scientist University of Houston College of Pharmacy presented the poster entitled, preclinical microbiome evaluation of novel policy inhibitor compounds. Using microbiome profiling, genomics, the office included that DNA pol IIIC compounds represent a targeted strategy to treat resistant gram-positive infections while preserving the microbiome structure, [indiscernible] downstream complications associated with antibiotic induced dysbiosis. We continue to identify and pursue funding opportunities for our Phase III clinical trial of [indiscernible] for ibezapolstat in acute CDI. We have several initiatives underway to this end and will report results and future updates. As we continually reported ibez clinical and nonclinical results continue to outperform in a series of potentially life-threatening infectious disease caused by a C. difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment and also have a low incidence of recurrence. Additionally, ibezapolstat has FDA QIDP and FastTrack designations for treatment of CDI as well as in Europe, small and medium enterprise or SME status. Furthermore, all after x compounds and preclinical development are eligible for QIDP and FastTrack designation, and they target gram-positive infections classified as a serious threat priorities by the CDC. We remain confident that while developing ibezapolstat's competitive profile continues to evolve and strengthen, we'll continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. And now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the first quarter of 2026. Rob?

Thanks, Dave. Our financial results for the first quarter ended March 31, 2026, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $9.3 million compared to $7.6 million as of December 31, 2025. During the quarter, the company raised a total of approximately $3.1 million of gross proceeds through purchases under its equity line of credit. Research and development expenses for the 3-months ended March 31, 2026 were $0.3 million compared to $0.6 million for the 3-months ended March 31, 2025, a decrease of $0.3 million. The decrease was primarily due to a decrease in manufacturing costs of $0.1 million and a decrease in consulting related costs of $0.2 million as a result of prior year trial preparation related expenses. General and administrative expenses for the 3-months ended March 31, 2026 were $1.4 million, that was compared to $1.6 million for the 3-months ended March 31, 2025, a decrease of $0.2 million. The decrease was primarily due to a $0.1 million decrease in professional fees and a $0.1 million decrease in legal costs. The company reported a net loss of $1.7 million or $0.62 per diluted share for the 3-months ended March 31, 2026, that was compared to a net loss of $2.1 million or $2.15 per diluted share for the 3-months ended March 31, 2025, all for the reasons previously mentioned. The company had 3,389,106 shares outstanding as of March 31, 2026. With that, I'll turn the call back over to Dave. Dave?

Thanks, Rob, and to all of you for joining us today. Before bringing the operator, Melissa, back to open the call for questions, I'm pleased to introduce to our call Dr. Michael Silverman, our Medical Director; and Bob DeLuccia, our Executive Chairman, to assist with Q&A regarding our rCDI program or any other matters of an R&D nature. Bob and Michael can also respond to questions regarding the recent FDA guidelines for pivotal Phase III trials in C. difficile. And now I'd like to turn the call over to our operator, Melissa, to open the call for any questions. Melissa?

[Operator Instructions] Our first question comes from the line of Jim Molloy with Alliance Global Partners.

I'd like to walk through the guidance, you mentioned if this gets formalized with the 1 trial only, the 1 trial needed. Can you walk you what the steps are to actually formalize that? And how confident are you that this will be or at least at the recurrent CDI or the Phase III CDI trial might fit underneath this rubric of...

Well, let me start out just by saying before I hand it over to Bob and Mike. We believe this is it's formalized as far as the FDA is concerned, it came out of its formal guidance Friday night of last week. Now whether that can be formalized in kind of our lineage of regulatory interaction with the FDA as it applies to ibezapolstat, that's I think the question that we have to answer with the FDA and -- and thankfully, we have a meeting schedule to address that, that Bob and Mike had talked about. Bob, would you like to add?

Sure. Thanks, Dave, and thanks, Jim, for the question. So yes, we're still going through this in detail. As Dave said, it just came out on Friday night. But at first pass, we don't see anything that will require a change in our pivotal trial design, which is already agreed to with the FDA. However, we're very excited to see that this new guidance explicitly states and it now formalizes what had been published previously in New England Journal of Medicine, but now specifically for C. difficile infection, in that it may be possible to rely on one adequate and well trolled trial with confirmatory evidence to meet the substantial evidence of effectiveness standard. And we've scheduled a meeting as Dave said, discussed this with the FDA. And Mike, maybe you can expand a little bit on what FDA considers as confirmatory evidence, which we think strengthens our position with the FDA?

Sure, Bob, do you hear me all right?

Yes.

I just want to emphasize something Dave and Bob said about the formalization, if you will. This new guidance refers back to a lineage of other FDA guidance is going back to at least 2019, discussing the feasibility and the requirements for a single trial. What is very important is the new guidance, which is the final guidance. It's not a draft guidance applies it specifically to C. difficile. And as Bob said, that's one of the things that helps us strengthen our position. One theme runs through all the guidances that we're discussing is that a single trial needs to be supported by what FDA considers to be more or less quoting substantial -- I'm sorry, confirmatory evidence of substantial efficacy, and by confirmatory evidence, they have a number of criteria, a number of categories of other evidence besides the Phase III trial that would contribute -- and we actually tick a few of those boxes, which, again, helps us strengthen our position. One is mechanistic data, okay? And [indiscernible] effective, that is something that we can -- we can demonstrate in a straightforward fashion because we have our activity in the test tube our in vitro data, our MICs or killing data for the bacteria. We also have in vitro test tube data showing anti-variance activity of our drug, and we have animal efficacy data in the model that is considered to be the standard and has predicted efficacy of drugs on the market. We know a great deal about the mechanism of action down to the molecular in fact, the atomic level, which will also support our case. We have microbiome data that Dave referred to, which is another mechanistic aspect that helps build the case for not just treatment efficacy but reduction of recurrence, and then circling back, you put that all together, the animal model, again, pulls all these factors together and demonstrates the activity. So that is our are position of confirmatory evidence of substantial efficacy.

Great. Thanks, Mike. Jim, does that answer your question?

That does. I guess one of the -- my last question would be on the [ phase label ]. You suggested there might be an interim to look at 10, you going to have 20 people in the trial, is expectation. What sort of the deal you expect -- you would like to get from this open label trial to serve for the design of the Phase III, hopefully, of the Phase III trial. And then maybe a quick clarification too, throughout the call, you talked about acute CDI, recurrent CDI. And so I don't know how do those differ materially from sort of regular CDI, and I guess, recurring obviously, it's recurring, but treating the three at the end of the day, it's still sort of the same treatment, correct?

Mike, go ahead, you can clarify the between the Phase III...

So Jim, a couple of different aspects of your questions. One is that the 20-patient trial we're doing is in a population with multiple recurrences. That's different than the Phase III trial we've been talking about as a potential single pivotal trial, which is in patients who've had a single episode or no more than 1 recurrence, okay? You're absolutely right that when a patient gets an acute episode of C. diff infection, the patient requires antibiotic treatment, okay? That's where the acute episode -- generally, it's 10 days, at least that's the standard for the drugs that are approved now. So that's 10 days of treatment to cure the acute episode. The problem is that depending on what you read and what drug you use 20% or 30% of those patients will have at least 1 recurrence and the recurrence is because the initial infection sets up conditions to allow C. diff to recur. The interesting thing about the new guidance is that for the first time, it talks about not just treatment and prevention of recurrence, it talks about long-term prevention of disease in a prophylactic fashion. So the opportunities for studying patients for short-term cure for kind of intermediate or let's say, 1-month reduction of recurrence and then for longer-term follow-up for even further reduction in recurrence have actually grown. So we still will be treating people acutely, all right, and then we observe after that for rates of recurrence. I'm not sure if that answers all your questions.

Well, so just to add to that, there's two separate pathways. So you can think of it Jim, we have kind of two potential shots on goal. So there is the Phase III pathway in what we call acute CDI which is currently 2 Phase III registration trials that made now one trial. And then there's a separate pathway under the LPAD guidance for recurrence that's starting with an exploratory 20-patient Phase II, look at the data, and then we would do, hopefully, 1 trial for Phase III if the FDA agrees, we have LPAD designation and then we can get approval in that sense. So there's two separate pathways to FDA approval.

And that's rCDI, Dave -- you're right. That separates [indiscernible].

Our next question comes from the line of Jason McCarthy with Maxim Group.

Can you talk a little bit about -- and you mentioned it briefly, the importance of the microbiome alterations or rather preservation of the good bacteria, how much emphasis there was in the new guidance related to that and how you plan to present your microbiome data when you meet with FDA this summer to talk about kind of, I guess, the parameters of the Phase III?

Yes. Thank you, Jason. That's a great question. Mike, you can expand a little bit on that on microbiome with the work of Kevin Garey at Houston.

Yes, agreed. That is a great question. The microbiome assessment is key to our program, but it's important to understand that this is not something that would be considered for an approvable claim, not something that would initially get us approval or perhaps even end up in the label. Right now, it's an ancillary marker, exploratory marker, because it is not something that the patient experiences. However, the microbiome is critically important in treatment and reduction of recurrence in C. diff. When a C. difficile infection occurs, there is -- and antibiotics, given there's tremendous alteration of the bacteria, which normally live in gut, the microbiome. The balance of those bacteria changed such that the metabolism in the gut changes, particularly metabolism of bile acids and certain bile acids are critical in actually suppressing the growth of C. difficile. So when you give antibiotic like [indiscernible] and the bacteria that create those beneficial metabolites are gone. So you don't have those metabolites to suppress C. difficile. That is one of the key aspects in leading to recurrent disease, the absence of good bacteria and the good metabolites to suppress C. diff. We've seen through our work, as Bob said, Dr. Garey at University of Houston that ibezapolstat and, in fact, other compounds in the same series that Dave mentioned, are much gentler on the microbiome, do not lead to the eradication of the "good bacteria" like a drug such as vancomycin would do. So those bacteria that are producing the bile acids that suppress the growth of C. difficile are maintained and we believe that's a main feature in reducing recurrence. Again, that's not something that would get approval, but it's part of the pharma [indiscernible] the drug that we think we can leverage.

Great. And also, when you're thinking about, I guess, the parameters for the Phase III and you're talking about your data with the FDA this summer with the recurrence measure or reduced recurrence measure, be it that standard 30 days, would you go out further, even if exploratory because you had those 5 people that went out. I think it was 90-plus days that had no recurrent? And then all of that with -- are you going to have to go head-to-head with vancomycin or [indiscernible]?

Yes. Great question. So again, you're absolutely spot on on this one. The standard that you'll see for the drugs that are approved and in the studies that have been done is following the patients for 1-month after the completion of treatment to assess reduction recurrence [ fidaxomicin ] does have some raw numbers in its label, but it does not have a claim for reduction of recurrence. And that's a long story behind that. And -- but right now, that's the current standard. We intend to follow patients as we did in Phase II. We intend to follow them in Phase III for that kind of 1 month standard, but and you're, again, spot on. We're going to follow them out to additional month to assess for recurrence. And the reason that we're -- we've chosen that number is because there are 2 agents out there that are approved for reduction of recurrence and their label has the claim for 8 weeks following acute treatment. So we will be following patients for essentially 2 months after the initial treatment to [indiscernible] recurrence.

Great. Thank you, Mike, and that's an important distinction, and that's going to give us a specific advantage. Thanks for the question. For sure.

I'm sorry, those 2 drugs are which that have the 8-week claim?

Yes. These are in the category that's called live biological products that are essentially human-made fecal microbiome transplant surrogates. One is Vowst V-O-W-S-T and one is Rebiota, R-E-B-Y-O-T-A and they're both live bacteria, which are administered to try to restore the normal microbiome balance into that.

[Operator Instructions] Our next question comes from the line of Matthew Keller with H.C. Wainwright.

So just quickly, the FDA guidance also mentions or like emphasize thoughtful flexion of patient populations, especially when it comes to elderly populations. So I was wondering if maybe you could talk to us about how your protocols also might align with this part of the guidance as well?

Yes Mike Silverman here again. Yes, good question. We -- we're sensitive to that, and we've actually expanded our population relative to Phase to include essentially all agents. This also gets to the notion of a single trial because one of the items that support single trial for approval is having diversity of your sites, diversity of your patient population, consistency across various subgroups. The types of subgroups, we can actually actually obtained are not all that varied, okay? We do have the age. We will have geographic diversity, we assume we'll have ratio and ethnic diversity. And the only other real factor that enters in here is whether it's a first occurrence or whether it's the first recurrence, other than that, the disease is relatively homogeneous, but we are sensitive to the notion of different segments of the population and the need to show consistency across all the segments. I hope that helps.

Yes, yes, absolutely. And then also kind of change the subject a little bit, but just more housekeeping. When can we expect the start of the rCDI trial?

We're actually in a startup mode right now. as we are contacting sites, the planned number of sites, and we're interacting with those sites for site qualification visits right now. So we're actually in a startup mode. We hope to see our first patient in, I would say, probably August time frame. And hopefully, we can beat that if we can accelerate it.

Ladies and gentlemen, that concludes our question-and-answer session, and we'll conclude our call today. We thank you for your interest and participation. You may now disconnect your lines.

Thanks, Melissa.