Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals first quarter 2026 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the call over to your host, Mr. Rob Shawa, 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 accorexpharma.com. Joining me today is Dave Lucci, President and CEO of Accorex, 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 10Q, which we filed yesterday, Monday, May 11, 2026. You are questioned not to place undue reliance on these forward-looking statements and after access claims 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 DeLucia, and our Medical Director, Michael Silverman, have joined us today and will be available for those questions about our R-CDI 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 9th, 26, we issued a press release announcing that we're starting up a groundbreaking ibuprofen trial program in patients with recurrent CDI or R-CDI. that has the potential to shift the paradigm of treatment and prevention of recurrent C. diff from two agents to just one, our Ibezopulstat. When coupled with Ibezopulstat Phase II results, which showed a 96% cure rate with no recurrent C. diff in 25 of 25 patients who were cured, scaring the microbiome, this new trial has the potential to position Ibezopulstat to be a new standard of care as the first agent to treat both acute CDI and prevent R-CDI. In the acute CDI phase 2 trial, all 25 patients, 100%, treated with I-VEZ, who experienced a clinical cure of CDI, were free of recurrence one month after treatment. And very importantly, five of five of these patients who were observed for three months after treatment remained free of recurrence. The new clinical trial in R-CDI builds on a physical strength, mainly 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 in patients with multiple recurrent CDI who had at least three episodes of CDI within the past 12 months. This will inform elements of a planned active control phase 3 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 3 pivotal RCDI trial and per the operative FDA procedure, after it's passed the request, FDA approval for treatment and prevention of RCDI under the FDA's limited population pathway for antibacterial and antifungal drugs guidance for industry. ACRx clinical program in the broader acute CDI patient population is ready to advance to phase three international physical 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. that is for registration. If formalized, and we can talk about that in the Q&A, this would end the long-standing two-trial dogma. We look forward to 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 one pivotal clinical trial. On March 30th, 2026, we announced that the Korean Patent Office granted a new patent which covers DNA polymerase 3C inhibitors, including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen ACRES's intellectual property portfolio and represents the most recent addition to our standing series of granted patents in the U.S. and internationally. To date, we've secured 10 patents, including five 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, and significantly, a new patent was recently issued relating to Ibenzapulstat and its use to treat CEI 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 the USPTO granted a new patent for our DNA-PAL3C inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules. On April 16, 2026, the company announced the closing of a registered direct offering About 825,085 shares of our common stock were pre-funded warrants in lieu thereof at a purchase price of $3.03 per share for a pre-funded 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 resources to conduct the exploratory clinical trial in recurrent C. difficile infection. And just last month, a scientific poster showing our new DNA-PAL3C systemically absorbed compounds in preclinical development to treat other gram-positive infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a high microbial diversity similar to baseline and distinct from . 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. Karshida Begum, research scientist, University of Houston College of Pharmacy, presented the poster entitled, preclinical microbiome evaluation of novel palsy inhibitor compounds. Using microbiome profiling metagenomics, the authors concluded that BNA-PAL3C compounds represent a targeted strategy to treat resistant gram-positive infections while preserving the microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis. We continue to identify and pursue funding opportunities for our phase three clinical trial program for ibuprofen and acute CDI. We have several initiatives underway to this end and we'll report results in future updates. As we continually reported, IBEZ 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. They also have a low incidence of recurrence. Additionally, Ibexapoltec has FDA QIDP and fast track designations for treatment of CDI, as well as in Europe, small and medium enterprise or SME status. Furthermore, all accurate compounds in preclinical development are eligible for a QIDP and fast-track designation. And they target rare positive infections classified as serious threat priorities by the CDC. We remain confident that while development by Vesipol staff'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 Schaller, 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 three months ended March 31, 2026 were $.3 million, compared to $.6 million for the three 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 three months ended March 31, 2026 were $1.4 That was compared to $1.6 million for the three months ended March 31, 2025, a decrease of $.2 million. The decrease was primarily due to a $.1 million decrease in professional fees and a $.1 million decrease in legal costs. The company reported a net loss of $1.7 million or $0.62 per diluted share for the three months ended March 31, 2026. That was compared to a net loss of $2.1 million, or $2.15 per diluted share for the three months ended March 31, 2025, all for the reasons previously mentioned. The company had 3,389,106 shares outstanding as of March 31, With that, I'll turn the call back over to Dave. Dave?

Thanks. Thanks, Rob, and to all of you for joining us today. Before bringing our 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 DeLucci, our executive chairman, to assist with Q&A regarding our RCEI 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 three 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?

Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question comes from the line of Jim Malloy with Alliance Global Partners. Please proceed with your question.

Hi, guys. Thank you for my questions. I'd love to walk through the new guidance. You mentioned, you know, if this gets formalized with the one trial, only the one trial needed. Can you walk me through what the steps are to actually formalize that, and how confident are you that this will be, or at least that the recurrent CDI or the Phase III CDI trial might fit underneath this rubric?

Well, let me start out just by saying, before I turn it over to Bob and Mike, we believe this is formalized As far as the FDA is concerned, it came out as formal guidance Friday night of last week. Now, whether or not it can be formalized in, you know, kind of our lineage of regulatory interaction with the FDA doesn't apply. So, as opposed to that, that's, I think, the question that we have to answer with the FDA. And thankfully, we have a meeting scheduled to address that that Bob and Mike can talk about. Bob, would you like to?

Yeah, sure. Thanks, Dave. And thanks, Jim, for the question. So, yeah, we're still going through this in detail. As Dave said, it just came out 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 the 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-controlled trial with confirmatory evidence to meet the substantial evidence of effectiveness standard. And we scheduled a meeting, as Dave said, discussed this with the FDA. And, you know, Mike, maybe you can expand a little bit on what FDA considers as confirmatory evidence which we think strengthens our position with the FDA, right? Sure, Bob.

Thank you. Thank you for that. Do you hear me all right? Yes. Okay. And thanks for the question. 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 guidances 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 a 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 that 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 three trial that would contribute. And we actually tick a few of those boxes, which, again, helps to strengthen our position. One is mechanistic data. Okay, and anti-infectives, that is something that 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 antivirulence activity of our drug, and we have animal efficacy data in the model that is considered to be the the standard and has predicted efficacy of other 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 position of confirmatory evidence of substantial efficacy.

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

That does. Thank you very much. I guess one of the quick, my last question would be on the phased label, you suggested there might be an interesting look at 10, you know, 20 people in the trial, the expectation. What's sort of the ideal you expect you would like to get from this open label trial to serve for the design of the phase three, hopefully the single phase three trial? And then maybe a quick clarification too, you know, throughout the call you talk about acute CDI, recurrent CDI, and so how do those differ materially from sort of regular CDI, and I guess recurrent obviously is recurring, but treating the three, at the end of the day, it's still sort of the same treatment, correct?

Yeah. Mike, go ahead. You can clarify between the phase three trials.

Sure, 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 three 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 one 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 for 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 is used, 20 or 30% of those patients will have at least one 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 one-month reduction of recurrence and then for longer-term follow-up for even further reduction of recurrence have actually grown significantly. 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, like we have kind of two potential shots on goal. So there's a phase three pathway in what we call acute CDI, which is currently two phase three registration trials, that may now become one trial. And then there's a separate pathway under the LPAD guidance for recurrency that's starting with an exploratory 20-patient phase two, look at the data, and then we would do hopefully one trial for phase three. 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 our CDA, Dave. You're right. It separates two. All right. Okay, Jim?

Excellent. Thank you for taking my questions.

Thank you, Jim. You're welcome.

Thank you. Our next question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Hi, guys. Thank you for taking the question. Can you talk a little bit about, and you mentioned it briefly, the importance of 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 three.

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

Yeah, I agree. That is a great question. Microbiome, 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, an 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 an antibiotic is given, there is tremendous alteration of the bacteria which normally live in the gut, the microbiome. The balance of those bacteria change 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 you give an antibiotic like Bancomox and maybe bacteria that create those beneficial metabolites are gone. So you don't have those metabolites that 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, with Dr. Gary at University of Houston, that Ivesipolstat 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, quote, 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 us approval, but it's part of the pharmacology of the drug that we think we can leverage. Thank you, Mike.

Great. Thank you. And also, when you're thinking about, I guess, the parameters for the phase three and you're talking about your data with FDA this summer, would the recurrence measure or reduced recurrence measure be as set standards 30 days, would you go out further, even if exploratory, because you had those five people that went out, I think it was 90-plus days that had no recurrence, and then all of that with, are you going to have to go head-to-head with vancomycin or fadaxomycin?

Yeah, great question. 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 one month after the completion of treatment. to assess reduction of recurrence. Fedastomycin 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. But right now, that's the current standard. We intend to follow patients, as we did in Phase 2. We intend to follow them in Phase 3 for that one-month standard. But, and you're, again, spot on, we are going to follow them out to an additional month to assess for recurrence. And the reason that we've chosen that number is because there are two agents out there that are approved for reduction of recurrence, and their label has the claim for eight weeks following acute treatment. So we will be following patients for essentially two months after the the initial treatment to assess for recurrence.

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

I'm sorry. Those two drugs are which that have the eight new plans?

Oh, yeah. These are in the category that's called live biological products. They're essentially human-made fecal microbiome transplant surrogates. One is VOST, 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 in the gut.

Got it. Thank you. Thanks for taking the questions, guys.

Thank you.

Thank you. Once again, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Our next question comes from the line of Matthew Keller with HC Wainwright. Please proceed with your question.

Hey, good morning, everyone. Thanks for the update and for taking our question. So just quickly, you know, the FDA guidance also mentions or, like, emphasizes thoughtful selection 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, this guidance as well.

Yeah, Mike Silverman here again. Yeah, good question. We're sensitive to that and we've actually expanded our population relative to phase two to include essentially all ages. This also gets to the notion of a single trial because one of the items that supports 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 obtain are not all that varied. Okay, we do have the age. We will have geographic diversity. We assume we'll have racial and ethnic diversity. And the only other real factor that enters in here is whether it's a first occurrence or whether it's a 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.

Yeah, yeah, absolutely. And then also kind of changing subjects a little bit, but just more housekeeping, when do we expect the start of the RCDI trial?

We're actually in 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 a first patient in, I would say, probably August timeframe. Hopefully we can beat that if we can accelerate it.

Yep, perfect. Makes sense. Thanks again for taking my questions.

Thank you. Thank you, Mike.

Thank you. 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.