ACXP

Greetings, welcome to the Acurx 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 0 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 acurxpharma.com. Joining me today is David P. Luci, President and Chief Executive Officer 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 ending March 31, and then turn the call over to David 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 quarter 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. 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 2026 and also to hear some recent updates. We'd be pleased to take any questions. For the Q&A, our Executive Chairman, Bob DeLuca, 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, 2026, 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 recurrent C.

C. difficile from 2 agents to just one, our ibezapolstat. When coupled with ibezapolstat phase II results, which showed a 96% cure rate with no recurrent C. difficile in 25 of 25 patients who were 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 ibe who experienced a clinical cure of CDI were free of recurrence 1 month after treatment. Very importantly, five of these patients who were observed for 3 months after treatment remained free of recurrence. The new clinical trial in rCDI builds on ibezapolstat's strength, namely that no patients who were cured of their infection experienced a recurrence.

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 ibezapolstat 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 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, Acurx 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. 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 can talk about that in the Q&A, this would end the long-standing 2-trial dogma. We look forward to FDA's further clarification and the 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 30, 2026, we announced that the Korean Intellectual Property Office granted a new patent which covers DNA polymerase IIIC inhibitors, including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen 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. Significantly, a new patent was recently issued relating to ibezapolstat and its use 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 2026, we announced that the USPTO granted a new patent for our DNA Pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under U.S. patent rules.

On April 16th, 2026, the company announced the closing of a registered direct offering of 825,085 shares of our common stock or pre-funded warrants in lieu thereof at a purchase price of $3.03 per share or 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.

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. Just last month, a scientific poster showing our new DNA Pol IIIC 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 gut microbial diversity similar to baseline and distinct from linezolid. This poster was presented at the 35th Congress of ESCMID Global, the European Society of Clinical Microbiology and Infectious Diseases 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 DNA Pol IIIC Inhibitor Compounds. Using microbiome profiling metagenomics, the authors concluded that DNA Pol IIIC 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 III clinical trial program for ibezapolstat and acute CDI. We have several initiatives underway to this end and will report results in future updates. As we've continually reported, ibez clinical and non-clinical results continue to outperform in a series of 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 and also have a low incidence of recurrence.

Ibezapolstat has FDA QIDP and Fast Track designations for treatment of CDI, as well as in Europe, small and medium enterprise or SME status. All Acurx compounds in preclinical development are eligible for QIDP and Fast Track designation, and they target gram-positive infections classified as serious threat priorities by the CDC. We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we'll continue to navigate successfully through these challenging times in the macroeconomic environment in our industry sector. Back to our CFO, Rob Shala, 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 $0.3 million. Compared to $0.6 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 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 three 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. 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 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. Now I'd like to turn the call over to our operator, Melissa, to open the call for any questions. Melissa?

Our first question comes from the line of James Molloy with Alliance Global Partners. Please proceed with your question.

Hi, guys. I just take my questions. I'd love to walk through the new guidance. You mentioned, you know, if this gets formalized with the 1 trial, only the 1 trial needed. Can you walk through what the steps are to actually formalize that? 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 of

Well, let me start out just by saying, before I turn it over to Bob and Mike, we believe this is it's 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 as it applies to ibezapolstat, that's, I think, the question that we have to answer with the FDA. Thankfully, we have a meeting scheduled to address that Bob and Mike can talk about. Bob, would you like to-

Yeah

add to that?

Sure. Well, thanks, Dave, and thanks, Jim, for the question. Yeah, we're still going through this in detail. As Dave said, it just came out Friday night. 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 standards. We've scheduled a meeting, as Dave said, to discuss this with the FDA.

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. Mike?

Sure, Bob. Thank you. Thank you for that. Do you hear me all right?

Yep.

Yes.

Yep, the line's good. Okay, thanks for the question. I just want to emphasize something David P. Luci and Robert J. DeLuccia 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. As Robert J. DeLuccia said, that's one of the things that helps to strengthen our position. The 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.

By confirmatory evidence, they have a number of criteria, a number of categories of other evidence besides the phase III trial. That would contribute. We actually tick a few of those boxes, which again, helps us strengthen our position. One is mechanistic data, okay? In 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 anti-virulence 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 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. Circling back to put that all together, the animal model, again, pulls all these factors together and demonstrates the activity. 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 my last question would be on the phase label you suggest there might be an interim look at 10. You're gonna have 20 people in the trial's expectation. What's sort of the ideal you would like to get from this open label trial to serve for the design of the phase III hopefully the single phase III trial? Maybe a quick clarification too. You know throughout the call you talk about acute CDI recurrent CDI. How do those differ materially from sort of regular CDI? I guess recurrent obviously it's recurring but treating the threeAt the end of the day, it's still sort of the same treatment, correct?

Yeah. Mike, go ahead. You know, you can clarify

Yeah.

between the phase III trials.

Sure.

Yep.

Sure. 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 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 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. That's 10 days of treatment to cure the acute episode. The problem is that, depending on what you read and what drugs you use, 20 or 30% of those patients will have at least one recurrence.

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. 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. We still will be treating people acutely, all right? Then we observe after that for rates of recurrence. I'm not sure if that answers all your questions.

Well,

That

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

That's rCDI, Dave. You're right. To separate-

Yeah.

the two. 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 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?

Yeah. Thank you, Jason. 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, agreed. 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. diff, C. difficile infection occurs, 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 metabolism in the gut changes, particularly the metabolism of bile acids. Certain bile acids are critical in actually suppressing the growth of C. difficile. When you give an antibiotic like vancomycin and the bacteria that create those beneficial metabolites are gone. 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. 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 quote good bacteria, like a drug such as vancomycin would do.

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. Yeah.

Great. Thank you. Also, when you're thinking about, I guess, the parameters for the phase III, and you're talking about your data with FDA this summer, would the recurrence measure or reduced recurrence measure be it's that standard 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? all of that with, are you gonna have to go head-to-head with vancomycin or fidaxomicin?

Great question. Again, you're absolutely spot 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. 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. 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 kinda one-month standard. You're again, spot on, we are gonna follow them out to an additional month, to assess for recurrence.

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. We will be following patients for essentially two months after the initial treatment to assess for recurrence.

Great. Thank you, Mike. That's an important distinction, and it's gonna give us a specific advantage. Thanks for the question, for sure.

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

Oh, yeah. These are in the category that's called live biological products. They're essentially, human-made fecal microbiome transplant surrogates. One is VOWST, V-O-W-S-T, and one is REBYOTA, R-E-B-Y-O-T-A. 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 one on your telephone keypad. Our next question comes from the line of Matthew Keller with H.C. Wainwright. Please proceed with your question.

Hey, good morning, everyone. Thanks for the update and for taking our question. Just quickly, you know, the FDA guidance also mentions or, like, emphasizes thoughtful selection of patient populations, especially when it comes to elderly populations. 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.

Michael Silverman here again. Good question. We're sensitive to that, we've actually expanded our population relative to phase II 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. 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. Yeah, absolutely. Also kind of changing subjects a little bit, but just more housekeeping. When can we expect the start of the RCDI trial?

Well, we're actually

Go ahead, Bob.

Yeah, no. 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. 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, Matt.

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

Greetings, and welcome to Acurx Pharmaceuticals' conference call to discuss full year and fourth quarter 2025 financial results. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Thank you. Please go ahead.

Thank you, Donna. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the year and fourth quarter 2025, which is available on our website at acurxpharma.com. Joining me today are Robert DeLuccia, Executive Chairman of Acurx, Dr. Michael Silverman, Medical Director of Acurx, who will be available for questions related to our R&D activities and strategy during the Q&A period, and David Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from the year and fourth quarter ended December 31, 2025, and then turn the call back over to Dave for his closing remarks.

As a reminder, during today's call, we'll be making certain forward-looking statements which are based on current information, assumptions, estimates, and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our annual report on Form 10-K, which we filed yesterday, Thursday, March 12, 2026. You are cautioned not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast, today, March 13, 2026. I'll now turn the call over to David Luci. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and year ended December 31, 2025, and also to hear some recent updates, which we're excited about. We'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the fourth quarter of 2025, or in some cases, shortly thereafter. First, in October, the company received gross proceeds from the execution of 170,000 Series F Warrants of approximately $1.4 million. Also, in October, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline.

Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, who's with us this morning, and Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the ibezapolstat clinical program. The company's presentation included an update on ibezapolstat and its microbiome-sparing properties. Also presented were new colonic microbiome data from a state-of-the-art mouse infection model showing the potential microbiome-sparing class effect of representative compounds from our DNA Pol IIIc inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Garey stated, "Initial work on the novel lead DNA Pol IIIc inhibitor compounds indicate that the positive microbiome sparing results from our ibezapolstat studies may be a class effect.

This is an important finding because microbiome sparing likely contributed to ibezapolstat's sustained efficacy in the phase II trial for C. diff infection, where no patient cured of CDI experienced a recurrence. In our recent experiments, mice given the comparator antibiotic, linezolid, demonstrated an overabundance of uncommon and harmful Gram-negative bacteria known to contribute to recurrence of infection. Dr. Gary further stated, "These data indicate a low probability for DNA Pol IIIc inhibitors to increase the risk of causing a C. diff infection, vancomycin-resistant Enterococcus, or other gut microbiome-related infections." In November, the company announced that the Nature Communications scientific journal published results from its scientific collaboration with Leiden University Medical Center, demonstrating structural biology research that reveals for the first time a DNA Pol IIIc inhibitor, ibezapolstat, bound to its target.

The publication is entitled "A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase Pol IIIC of Gram-Positive Priority Pathogens." This is an important milestone in Acurx's highly productive scientific collaboration with Leiden University Medical Center in Holland, in advancing development of these new to nature compounds, fortifying the foundation for the rational development of this innovative class of antimicrobials against other Gram-positive priority pathogens. On March 9, 2026, we issued a press release announcing that we are launching a groundbreaking ibezapolstat clinical trial program in patients with recurrent CDI that has the potential to shift the treatment paradigm and prevention of rCDI from two agents to one agent.

When coupled with ibezapolstat's phase II results of being highly effective, 96% clinical cure in 26 patients in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position ibezapolstat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of recurrent CDI. In our phase II trial, all 25 patients treated with ibezapolstat who experienced a clinical cure were free of recurrence one month after treatment, and five out of five of these patients were observed for three months after treatment, and they remained free of recurrence. During our Q&A this morning, members of our R&D team will be available to answer any questions about this new trial program.

Briefly, this new clinical trial in rCDI begins with an open-label pilot trial to gain experience with ibezapolstat in patients with multiple recurrent CDI, with at least three episodes of CDI within the past 12 months. This will inform elements of a planned active controlled phase III registration trial in the rCDI indication to be implemented following favorable results from the open-label 20-patient trial. Upon subsequent successful completion of the phase III pivotal rCDI trial and per the operative FDA procedure, the company plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs guidance for industry, published in 2020. Acurx's clinical program in the broader CDI patient population is ready to advance to phase III international pivotal clinical trials.

In this regard, we're very excited about the FDA's recent announcement, published in the New England Journal of Medicine, that a one trial requirement will be FDA's new default standard for registration. If formalized, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs, such as the opportunity to seek marketing approval for the broader CDI population with one pivotal clinical trial. In February 2026, we announced that the U.S. Patent and Trademark Office granted a new patent for our Pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under U.S. patent rules.

We continue to identify and pursue funding opportunities for our phase III clinical trial programs for ibezapolstat, as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end, and we'll report in future updates as appropriate. As we've continually reported, ibezapolstat clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Additionally, ibezapolstat has qualified infectious disease product and fast track designations from the FDA for the treatment of C. difficile infection, as well as SME or small and medium enterprise status in Europe.

We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the full year and fourth quarter ended December 31, 2025. Rob?

Thanks, Dave. Our financial results for the fourth quarter and year ended December 31, 2025, were included in our press release issued earlier this morning. The company ended the year with cash totaling $7.6 million compared to $3.7 million as of December 31, 2024. During the quarter, the company raised a total of approximately $1.5 million of gross proceeds through purchases under the equity line of credit, with gross proceeds of purchases under the equity line of credit totaling approximately $4 million for the full year of 2025.

Research and development expenses for the three months ended December 31, 2025, were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million. The decrease is due primarily to a decrease in manufacturing costs of $0.2 million and a decrease in consulting costs of $0.3 million as a result of prior year trial-related expenses. For the 12 months ended December 31, 2025, research and development expenses were $1.8 million versus $5.4 million for the 12 months ended December 31, 2024.

The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing-related costs and a $1 million decrease in consulting costs, as prior year had higher expenses related to phase IIb and phase III preparation costs. General and administrative expenses for the three months ended December 31, 2025 were $1.3 million compared to $2 million for the three months ended December 31, 2024, a decrease of $0.7 million. The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees.

For the 12 months ended December 31, 2025, general and administrative expenses were $6.3 million versus $8.7 million for the 12 months ended December 31, 2024, a decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees, a $1.4 million decrease in share-based compensation, a $0.4 million decrease in compensation costs, partially offset by a $0.3 million increase in legal costs.

The company reported a net loss of $1.6 million, or $0.73 per diluted share for the three months ended December 31, 2025, compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8 million or $5.32 per diluted share for the twelve months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the twelve months ended December 31, 2024, all for the reasons previously mentioned. The company had 2,348,113 shares outstanding as of December 31, 2025.

With that, I'll turn the call back over to David Luci.

Thanks, Rob, and to all of you for joining us today. Before bringing our operator, Donna, back to open the call for questions, I'm pleased to welcome to the call Michael Silverman and Robert DeLuccia, our Medical Director and Executive Chairman, respectively, to assist with further explanation of our recurrent C. diff and CDI infection trial program. Bob, would you like to add any comments?

Sure. Thanks, Dave. As you said, you know, these are very challenging times, but we think we can rise above them head on with our new clinical development plan. I think in phase II, as Dave said, ibezapolstat was demonstrated to be highly effective in both curing the acute C. diff infection and in preventing recurrence. Based on this, we believe it has the potential to be the first to demonstrate clinical success in both the treatment of the infection and the prevention of recurrent CDI. Such success would shift the paradigm of treatment and prevention of rCDI from two agents to one.

I think this would be a game changer to the public health threat that affects approximately 500,000 patients with CDI each year in the U.S., results in approximately 30,000 deaths, and it generates a related public health cost burden of approximately $5 billion, of which $2.8 billion is related to recurrent CDI. I also think that our new clinical program strengthens ibezapolstat's competitiveness, and if approved for marketing, gives an even more attractive value proposition in the marketplace. Which, by the way, ibezapolstat commercial supply chain of active pharmaceutical ingredient and packaged product will be made in America. Thanks, Dave.

Thanks, Bob. Now, back to Donna, our operator for today's call for questions. Donna?

Thank you. Ladies and gentlemen, the floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Again, that's star one to register a question at this time. Today's first question is coming from Jason McCarthy of Maxim Group. Please go ahead.

Good morning, guys. Thanks for taking the questions. I have a few, so if you just bear with me. Starting with the new recurrent CDI trial, for the primary endpoint, I'm assuming it's prevention of a recurrence, how far out do you have to go? Is it three months, six months, one month, and so on? And what is the cost of that trial? Bob?

Yeah. First question was how far out you mean in terms of evaluation through the endpoint? How long?

Yes, sir. Mm-hmm.

Yeah. Mike, you can take that question if you like. Just explain the treatment period as well as the follow-up period.

Sure. Thanks for the question, Michael Silverman here. Following the end of treatment, we will observe patients from cure of the disease to a first endpoint, a primary assessment endpoint of eight weeks. That's based on other products that are out there having been approved for prevention of recurrent disease. The standard there has been eight weeks. The precedent has been eight weeks. That will be our endpoint for recurrent disease. We will continue to follow patients out for approximately six months after the end of therapy to gather additional data.

Okay. Just as a follow-up to that, when you go out to six months in general, what do you see as the rate of recurrence with vanc or any other treatment that they're getting on average?

Yeah, it's a good question. Thanks. We may not have data out to six weeks on the drugs that are out there. That has not necessarily been the standard follow-up. Vancomycin, we can see rates of recurrence between 20% and 40%. You know, for the anti-recurrence therapies that are out there like Vowst and Rebyota, those recurrence rates are down in the range of 15%-30%. I'm talking about eight weeks, the label indication.

Okay, Jason?

Got it. Yes.

Good. Dave, you wanna address the

Thank you.

Dave, you wanna address the cost question?

The only thing I think we left out is the treatment period. I think there's a small modification to that, Jason.

Yeah.

Bob, do you wanna provide that?

Yeah, go ahead, Mike. The initial treatment

Sure. You may recall that in our prior trials, we've used 10-day treatment period because, again, that's been standard of practice, a standard of care for the other drugs that have improved vancomycin, fidaxomicin. For this trial, for the recurrent disease trial, we're going to a 14-day treatment period for all patients. That's based on prior work that's been done with the anti-recurrence drug with the anti-recurrence agents, longer period of treatment for the acute episode may result in a higher cure rate, which would give us a more robust sample size in which to evaluate recurrence.

Got it. The cost-ish.

Dave?

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

It's likely that the current cash balance, maybe with a little bit of a top off, gets you through this, I guess we call it a pilot study in recurrent CDI, and is that something that we could see, the start and conclusion of in 2026?

We'll certainly start enrolling in 2026 in the second half. You know, we'll see how far we get with the enrollment. We think we have some really high enrolling centers, but we wouldn't expect to be fully enrolled for about 12-15 months.

Okay.

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

Okay. Perfect. Then just two more quick ones, then I'll jump back. If this pilot is successful, does it change, and you're starting to think about recurrent CDI for the phase III, does that change the size, the potential size of a phase III? 'Cause if it was acute, I think it was somewhere in that 400-500 patients per trial. Two phase IIIs, I know that the narrative seems to be changing to one phase III these days. Just for recurrent CDI in general, do you need less patients to get an approval versus acute?

Thank you, Jason, for that question. Mike, you can answer that in terms of what we are projecting for the follow-on trial to the open-label. We have a range of estimates right now, but it depends upon what we see in the open-label trial. Mike?

Yeah. I'd like to emphasize what Bob said. Right now, we don't have any treatment data with ibezapolstat in this patient population, so we don't know the true effect size. We have very good estimates of the other agents that are out there, Jason, as you mentioned. We still need to gather the data on the ibezapolstat in terms of clinical cure rate and prevention of recurrence. Based on what we think are reasonable assumptions, that is going back to our phase II trial in a slightly different patient population, we're currently projecting somewhere between 360 and 400 patients for a single trial in the recurrent CDI indication.

Got it. Okay, that makes sense. Just lastly, I know you guys had mentioned U.S.-based manufacturing, which seems to be a very important issue these days with the current administration. Is that something that you're really trying to make headway with regulators on or the current administration in terms of having ibezapolstat. You could see a Pol IIIC inhibitor being used in lots of different things. Maybe it's something the government is interested in stockpiling. Dave, do you wanna just kinda opine, if you would, on that aspect of the U.S.-based manufacturing.

Yeah. I think.

Yeah.

I think you hit it pretty straight on, Jason. You know, we're continuing to have detailed discussions with government agencies, including BARDA. You know, it's important to them in their consideration of a public-private partnership that our program be made in America. That's part of what makes them excited about getting appropriate funding allocated, you know, to each sponsor that's looking for government money, as you say, these days under this administration.

Yeah. I agree, Dave. I think the point about potential government stockpiling on these, one of the things that's working in our favor is that our ibezapolstat and Pol IIIC's in general are very stable over time. Our ibezapolstat API, right now, we have about 48 months stability and probably closer to five years stability, and similar long-term stability in package form. That makes it prime for stockpiling.

Yeah, Jason.

Got it. Mm-hmm.

I'd just like to add one other little one for you. You know, in one of my conversations on Capitol Hill, I heard from a former Navy pilot that MRSA is, you know, kinda burgeoning greatly in on Navy ships. The government apparently is looking for a new pipeline in that area. As you know, we have something for that.

Yeah.

Okay. I think that's all my questions, for now. Thank you, for taking the time. Appreciate it.

No problem. Thank you.

Thank you. Our next question is coming from James Molloy of Alliance Global Partners. Please go ahead.

Hey, guys. Morning. Thank you for taking my questions. Sort of follow up on more on what Jason said or asked on the timings. In the March ninth press release, you said the first patient here in the phase II, fourth quarter 2026. So we understand correctly, it'd be 12-18 months after the fourth quarter of this year for this phase II to fully enroll?

Yeah. You know.

Yeah.

Sometime in the fourth quarter plus 12-15 months.

Okay. Obviously the phase III wouldn't start until some point after that.

Correct. Right.

It's possible the phase III could start, you can get interim data, and the phase III might start if things change during that trial.

David-

I'm sorry. Yeah, can you repeat that, Jason?

Is there any chance there can be an interim data out of the phase II that might spur the phase III to start? Or at this point, going down this path, the phase III confirmatory would not start until this phase II is done.

Yeah. I mean, it's possible. Dave or Mike, you can comment on that again, but we really would like to see the full 20 patients, you know, for decision-making and being best to size the following trial, the control trial. Mike or Dave?

Yeah. I mean, Go ahead, Mike.

You know, give us confidence.

Yeah.

Yeah.

Yeah. It's a balance, but I agree with Bob. The more data we have, the more confidence we have in being able to start the size the phase III trial. We can certainly get started with preparatory activities if we're encouraged. As Bob said, the more data we get, the better off we'll be.

Yeah. You know, I guess I would just like to put an asterisk on it, you know, understanding we ended our phase IIa in acute CDI early and the phase IIb, we ended early. You know, we're gonna take a preliminary look at the first 10 patients and, you know, we'll be able to call an audible if we, if our scientific advisory board feels it's appropriate.

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

It would depend on what the R&D guys think. I would imagine it would be after the eight weeks, because I don't think many of these programs have been evaluated for six months.

The most important endpoint is eight weeks, Dave.

Yeah.

Yeah.

Okay. Maybe it may be hard to answer this one, but another. You talk about the one trial deal, getting away from the two-trial dogma. Speaking with a number of other companies who've gone in front of the FDA, you know, obviously a lot of things have been said about trying to speed things up and make some changes to the clinical trial procedure. Some of these other companies I've spoke with have not found really much difference when they actually approach the FDA. They still are facing the same folks beneath. How, again, it may be early to say, but how real do they think the one trial might be?

Maybe I can take that one, Dave. I'm pretty encouraged that I think that is gonna be a game changer here, as well as a number of other things. One of our scientific advisors is Mark Goldberger, who's the former head of the antimicrobials division at the FDA. You know, his read on it, what has to happen next is that this needs to be formalized. They'll probably, and we believe they're already working on a guidance for industry to clarify some of the questions and lay down the parameters for what that would be. In our case, as I think one of, maybe, Jason mentioned this as well too, we had currently planned to do a roughly 474-patient phase II trial, excuse me, non-inferiority to vanco.

If we only have to do one trial, maybe we'll bump that up a little bit so that we cover the safety database with one trial. We're poised and ready to talk to FDA at the appropriate time. Things need to settle down before they actually get all their ducks in a row and sort of codify it. Does that help?

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

Oh, no, I've certainly seen it. I've seen it, seen him around, heard a lot of talk about the changes. They do need to get their ducks in a row still, so it's a bit of a duck thing still. I hope that certainly comes to pass.

Yeah.

All right, great. Thank you for taking the questions.

Thank you, Jim.

Thank you. Once again, ladies and gentlemen, if you do have a question, please press star one on your telephone keypad at this point in time. We'll pause a moment for any additional questions. We're showing no questions in the queue at this time. This concludes today's event. We'd like to thank you for your interest in Acurx Pharmaceuticals. You may disconnect your lines and enjoy your day.

Thank you, Donna.

Thank you, everybody.

Thank you. Be well.

Welcome to the Acurx Pharmaceuticals' third quarter 2025 conference call and business update. At this time, all participants are in a listen-only mode. A brief 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. It is now my pleasure to introduce your host, Robert Shawah, Chief Financial Officer. Thank you, sir. You may begin.

Thank you, Maria. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the third quarter of 2025, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the third quarter ended September 30, 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 quarterly report on Form 10-Q, which we filed today, Wednesday, November 12, 2025. 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, November 12, 2025. I'll now turn the call over to Dave Luci. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the third quarter 2025, and also to hear some recent updates. We would be pleased to take any questions. First, I'd like to briefly summarize a few of our key activities for the third quarter, or in some cases, shortly thereafter. On August 4, we effected a 1-for-20 reverse stock split of our issued and outstanding shares of common stock, and as a result of the reverse split, on August 26, we regained compliance with the minimum bid price requirements of $1 per share under the NASDAQ listing rules. In addition, we met the minimum stockholder equity threshold of $2.5 million under the NASDAQ listing rules. We're now in full compliance with all NASDAQ continued listing requirements, and our common stock will remain listed and traded on the NASDAQ stock market. In September, the Australian Patent Office granted a new patent for the company's class of DNA polymerase 3C inhibitors, including composition of matter. To date, Acurx has obtained three U.S. patents: one Israeli patent, one Japanese patent, one Indian patent, and now the Australian patent, in each case which cover the ACX-375C program related to DNA polymerase 3C inhibitors for infections caused by gram-positive bacteria, including MRSA, VRE, and PRSP, with other country-level filings in process. Also, in September, at our special meeting of stockholders, our stockholders approved an amendment to our certificate of incorporation to increase the total number of authorized shares of common stock from 200 million to 250 million. In late September, we filed the amendment with the Secretary of State of the State of Delaware with immediate effect. In October, the company received gross proceeds from the exercise of 170,000 Series F warrants for approximately $1.4 million. Also, in October, we are one of five companies selected to make a formal presentation at ID Week in Atlanta at the session entitled "New Antimicrobials in the Pipeline." Presenting on behalf of Acurx were Dr. Michael Silverman, our Medical Director, and Dr. Kevin Garry, Professor and Chair of University of Houston College of Pharmacy and the Principal Investigator for Microbiology and Microbiome Aspects of the ibezapolstat clinical trial program. The company's presentation included an update on ibezapolstat and its microbiome-sparing properties. Also presented were new colonic microbiome data from a state-of-the-art mouse infection model showing a potential microbiome-sparing class effect of representative compounds from our DNA polymerase 3C inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Garry stated, "Initial work on novel lead DNA polymerase 3C inhibitor compounds indicates that the positive microbiome-sparing results from our ibezapolstat studies may be a class effect. This is an important finding because microbiome-sparing likely contributed to ibezapolstat's sustained efficacy in the phase two trial for C. diff infection, where no patient cured of C. diff experienced a recurrence. In our recent experiments, mice given the comparator antibiotic linezolid demonstrated an overabundance of uncommon and harmful gram-negative bacteria known to contribute to recurrence of infection. Dr. Garry further stated, 'These data indicate a low probability for DNA polymerase 3C inhibitors to increase the risk of causing a C. diff infection, vancomycin-resistant enterococcus, or other gut microbiome-related infections. Next, this month, on November 10, the company announced that the Nature Communications scientific journal published results from our scientific collaboration with Leiden University Medical Center in the Netherlands, demonstrating structural biology research that reveals, for the first time, a DNA polymerase 3C inhibitor, ibezapolstat, bound to its target. The publication is entitled, "A unique inhibitor conformation selectively targets the DNA polymerase 3C of gram-positive priority pathogens." This is an important milestone in our highly productive scientific collaboration with Leiden University Medical Center in advancing development of these new-to-nature compounds, fortifying the foundation for the rational development of our innovative class of antimicrobials against other gram-positive priority pathogens. We continue to identify and pursue funding opportunities for a phase three clinical trial program for ibezapolstat, as well as consideration of alternative pathways to achieve success. We have several initiatives underway to this end, and we'll report in future updates as appropriate. As we've continually reported, ibezapolstat clinical and non-clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. diff 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. I'd also like to highlight that our company does recognize the month of November as C. diff Awareness Month, as designated by the CDC, and supports the work of the Peggy Lillis Foundation in raising awareness, educating, and advocating for the prevention, treatments, clinical trials, and environmental safety of C. diff infections worldwide. For more information about the work of the Peggy Lillis Foundation, please visit their website at cdiff.org. Additionally, ibezapolstat has FDA QIDP and FAST TRACK designation for treatment of C. diff, as well as SME, small and medium enterprise status in the EU. We also believe that ibezapolstat, if approved, could make a favorable economic impact by reducing the overall annual U.S. cost burden for C. diff infection of approximately $5 billion, of which $2.8 billion is due to recurrent infection. We remain confident that while development of ibezapolstat's competitive profile continues to strengthen, we will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the third quarter of 2025. Rob?

Thanks, Dave. Our financial results for the third quarter ended September 30, 2025, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $5.9 million, compared to $3.7 million as of December 31, 2024. During the quarter, the company raised a total of approximately $1.7 million of gross proceeds through purchases under the equity line of credit. In addition, after quarter end, the company raised an additional $1.4 million from a warrant exercise by one institutional investor. Research and development expenses for the three months ended September 30, 2025, were $0.4 million, compared to $1.2 million for the three months ended September 30, 2024, a decrease of $0.8 million. The decrease was due primarily to a decrease in manufacturing costs of $0.1 million and a decrease in consulting costs of $0.7 million as a result of the prior year trial-related expenses. For the nine months ended September 30, 2025, research and development expenses were $1.6 million versus $4.6 million for the nine months ended September 30, 2024. The decrease of $3 million was primarily due to a reduction of $0.7 million in manufacturing costs and a $2.3 million decrease in consulting costs due to higher trial-related costs in the prior year. General and administrative expenses for the three months ended September 30, 2025, were $1.6 million, compared to $1.6 million for the three months ended September 30, 2024. The expenses remained relatively consistent from the prior year, as a $0.2 million decrease in compensation-related costs were offset by a $0.1 million increase in legal fees. For the nine months ended September 30, 2025, general and administrative expenses were $4.9 million versus $6.8 million for the nine months ended September 30, 2024, a decrease of $1.9 million. The decrease was primarily due to a $0.6 million decrease in professional fees and a $1.3 million decrease in share-based compensation. The company reported a net loss of $2 million, or $1.23 per diluted share for the three months ended September 30, 2025. That was compared to a net loss of $2.8 million, or $3.45 per diluted share for the three months ended September 30, 2024. A net loss of $6.4 million, or $5.01 per diluted share for the nine months ended September 30, 2025, that was compared to a net loss of $11.3 million, or $14.23 per share for the nine months ended September 30, 2024, all for the reasons previously mentioned. The company had 1,800,299 shares outstanding as of September 30, 2025. With that, I'll turn the call back over to Dave.

Thank you, Rob. And to all of you for joining us today. Now back to the operator to open the call for questions. Maria?

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press Star 1 on your telephone keypad. 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 your handset before pressing the Star keys. One moment, please, while we poll for questions. Our first question comes from Jason McCarthy with Maxim Group. Please proceed with your question.

Hi. This is Joanne Lee.

Good morning.

Oh, sorry. This is Joanne Lee on the call for Jason McCarthy. Thank you for taking our questions. Starting with, given recent changes under the current FDA administration, do you see increased potential for the agency to prioritize domestically manufactured novel antibiotics? If you could share your perspective on the PASTOR Act, if there is any still meaningful potential for it to advance or impact the antibiotic funding landscape. Thank you.

Thank you, Joanne. So with regard to the FDA, we certainly see buds on the trees. Maybe this relates more to a sister agency that we're talking about with a public-private partnership. We're already FDA, FAST TRACK, and QIDP. There is some legislation that may be coming out related to novel drugs that treat life-threatening conditions that we may be able to avail ourselves to. We're not sure yet. We would be the first antibiotic under that program, but we're certainly on it and looking into it. The second component of your question, the PASTOR Act, I don't think anyone in Washington is focused on the PASTOR Act or Project Bioshield. Given what's going on in Washington, I think 90% of the folks down there are wondering what their new appropriation is going to be for fiscal 2026 because of the shutdown and that kind of thing. It's going to be until the end of the year until folks are sure what they're going to have to spend. I would expect both of those will continue to be under consideration when normalcy returns to the capital. That may take some time.

Got it. That was helpful. And just given recent shifts under the current FDA leadership, do you see increased potential for the agency? I'm sorry. Does the proposed clinical priority review voucher framework impact the company's regulatory approach or commercial strategy going forward?

No. It would be the same strategy. We would certainly try to avail ourselves of that program at the appropriate time. We're aware of it. We have a couple of phase three trials in front of us, along with the 20-patient take-all-comers trial in the secondary C. diff market that we'd like to get underway kind of ASAP.

Got it. And just the last one for me. Has the team explored the possibility of filing for approval based solely on the phase two ibezapolstat data? And I guess, what would the regulatory pathway look like if you were to take that route?

Yeah. We couldn't. If we could do that, we would. You need a safety database. We're going to need whatever we're able to kind of follow as the most recent regulatory pathway. If a new one, the conditional approval pathway, for example, we're still going to need phase three trial data to support the safety database.

Got it.

We don't have enough patients yet for the FDA to be comfortable.

Got it. Thank you so much. Appreciate you taking the time to answer our questions.

Thank you, Joanne.

Our next question comes from Matt Keller with HC Wainwright. Please proceed with your question.

Hello. Good morning. Thanks for taking our questions. Just one from us. You kind of touched on this, but you've had a number of recent publications and presentations. I'm kind of curious how these data might be informing or potentially changing your clinical strategy going forward, particularly ahead of the start of the potential phase three.

I mean, the data is compelling. I mean, to have a microbiome-sparing class effect, that means that as we get our second antibiotic in the pipeline into clinical trials, if our second program is effectively treating MRSA and anthrax and VRE, we'll be very confident that there are going to be very, very few or no reinfections because of the class effect of the microbiome-sparing mechanism of action. It doesn't really change the clinical program. What it does do is it makes us confident that we'll be able to demonstrate to the scientific community that we deserve a seat at the table. The way we'll do that is to do in the secondary or salvage market for C. diff. In the worst of the worst cases, we'll dose up to 20 patients who have had three prior episodes or more of C. diff treated by the standards of care. We expect to be able to show that we're able to cure those patients of their C. diff with lasting cures because of the elucidation we have now in our mechanism of action. We'll basically be saying to the scientific community worldwide, "The existing antibiotics that are standards of care are fine, but we deserve a seat at the table." We think that data will be compelling. We would anticipate that data will help us to engender a public-private partnership. It doesn't really change your primary strategy.

Yeah. It totally makes sense. Thanks for the update. Thanks again for taking the question.

Thanks, Matt.

Our next question comes from James Malloy with Alliance Global Partners. Please proceed with your question.

Hey, guys. Good morning. Thank you very much for taking my questions. I wonder if there's any way to put a framework or a timing around potential partnership discussions. I know it's always partnerships never there until it's there. You highlighted alternative or additional pathways in your prepared remarks for getting to phase three. Is there any way to put some error bars around when that could potentially happen? I have a couple of follow-ups. Thank you.

No problem. Thank you, Jim. Good morning. A partnership is a two-way street. We can't tell exactly when the people we're talking to are going to come to terms or if they're going to come to terms. I would be surprised if on the next earnings call, there hasn't been some major news for the company.

Excellent. Thank you for that. On the QIDP and FAST TRACK designation, there's no sort of expectation or time limit or sort of movement that has to go forward for those to keep going? Once you get them, you sort of have them in perpetuity?

Absolutely.

Got it. Thank you. And then just the last question too on the OpEx. Pretty steady state right now. You guys are, in some respects, holding fast. Are these numbers the numbers we should anticipate going forward, again, barring something substantial being announced before the next call?

Yes. We continue to tighten our belt. We would think that, if anything, our costs will continue to gradually go down. We've done a lot of cost cutting. I'm sure we can find more corners to cut. We're in kind of a good position with, I think we said $5.9 million, plus we had the $1.4 million after the end of the quarter. With $7 million-ish in the tank and another $9 million remaining on our ELOC, we can kind of bide our time while we wait for a public-private partnership or some sort of M&A activity.

Absolutely. Comments to Rob for keeping the steady hand of the tiller. Thank you, guys, for taking the questions.

Thank you so much, James.

We have reached the end of our question-and-answer session, which now concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.