Acurx Pharmaceuticals, Inc.

and welcome to the Accrax Pharmaceutical 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 Shaw, 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 accorexpharma.com. Joining me today is Dave Lucci, President and CEO of Accorex, 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 ACRx 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 12th, 2025. I'll now turn the call over to Dave Lucci. 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. Then we'd 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 4th, 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 26th, 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, ACRx 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 ACX375C program related to DNA-PAL3C inhibitors for infections caused by gram-positive bacteria, including MRSA, VRE, and PRSP, with other country-level filings and 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 Acurex were Dr. Michael Silverman, our medical director, and Dr. Kevin Gehry, professor and chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the Ibexipulstat clinical trial program. The company's presentation included an update on Ibexipulstat 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-PAL3C inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Gary stated, initial work on novel lead DNA 5-3C inhibitor compounds indicate that the positive microbiome sparing results from our Ibezopulstat studies may be a class effect. This is an important finding because microbiome sparing likely contributed to Ibezopulstat's sustained efficacy in the Phase II trial for C. diff infections. where no patient cured of C. diff experienced a recurrence. In our recent experiments, mice given the comparator antibiotic linazolid demonstrated an overabundance of uncommon and harmful gram-negative bacteria known to contribute to recurrence of infection. Dr. Gary further stated these data indicate a low probability for DNA-PAL3C inhibitors to increase the risk of causing a C. diff infection. mycomycin-resistant enterococcus, or other gut microbiome-related infections. Next, this month, on November 10th, 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-Py3C inhibitor a vesipulostat bound to its target. The publication is entitled, A Unique Inhibitor Confirmation Selectively Targets the DNA PAL3C 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 our Phase III clinical trial program for Iveza-Polistet, as well as consideration of alternative pathways to achieve success. We have several initiatives underway to this end and will report in future updates as appropriate. As we've continually reported, at Benzopulstat, 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, Ivesipulstat has FDA QIDP and fast track designation for treatment of CDI, as well as SME, small and medium enterprise status, in the EU. We also believe that Ibezopolstat, 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 by Ibezopolstat'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. And now back to our CFO, Rob Schaller, to guide you through the highlights of our financial results for the third quarter of 2025.

Rob? Thank you, Dave.

Our financial results for the third quarter ended September 30th, 2025, or 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 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. And 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. And 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 one on your telephone keypad. 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 your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question comes from Jason McCarthy with the Maxim Group. Please proceed with your question.

Hi, this is Joanne. Good morning. Oh, sorry. This is Joanne Lee on the call for Jason McCarthy. Thank you for taking our questions. So starting with, so 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 Pasteur Act, if there's any so 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 bugs on the trees. And maybe this relates more to a sister agency that we're talking about, with about a public-private partnership, but 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 Pasteur Act, I don't think anyone in Washington is focused on the Pasteur 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 26 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. So I would expect both of those will continue to be under consideration when normalcy returns to the capital. But that may take some time.

Got it. That was helpful. And just given recent shifts under their current FDA leadership, do you see increased potential for the agency I'm sorry, is the proposed clinical priority review voucher framework impacts 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. But, you know, we have a couple of phase three trials in front of us, along with the 20 patient take-all-comers trial in the secondary CDIF 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 a Phase IIb IVs as data? And I guess what would the regulatory pathway look like if you were to take that route?

Yeah, we couldn't, you know, If we could do that, we would, but there's, you know, you need a safety database. So we're going to need, you know, whatever we're able to kind of follow as the most recent regulatory pathway. If a new one, you know, 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. Well, thank you so much. Appreciate you taking time to answer questions.

Thank you, Joanne.

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

Hello, good morning, and 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.

It's not, I mean, the data is compelling. I mean, to have a microbiome-sparing class effect That means that, you know, as we get our second antibiotic in the pipeline into clinical trials, if our second program is effectively treating MRSA and anthrax and VRE, you know, 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. So it doesn't really change the clinical program, but 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. And 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 been diagnosed who have had three prior episodes or more of C. diff treated by the standards of care. And 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. So we'll basically be saying to the scientific community we're alive, you know, the existing antibiotics, their standards of care are fine, but we deserve a seat at the table. So we think that data will be compelling, and we would anticipate that data will help us to engender a public-private partnership. So it doesn't really change the primary strategy.

That totally makes sense. Thanks for the update, and 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 the phase three. Is there any way to put some error bars around when that could potentially happen? And then I have a couple follow-ups. Thank you.

No problem. Thank you, Jim. Good morning. So, you know, a partnership is a two-way street. So, you know, we can't tell exactly when the people we're talking to are going to come to terms or, you know, if they're going to come to terms. But I would be surprised if on the next earnings call,

there hasn't been some major news for the company. Excellent.

Then, thank you for that. Then, on the QIDP and FastTrack 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 OPAC. It's a pretty steady state, and 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.

And 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. But we're in kind of a good position with, you know, I think we said 5.9, plus we had the 1.4 after the end of the quarter. So, you know, with $7 million-ish in the tank and another $9 million remaining on our ELOC, you know, we can, you know, 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 a steady hand on the Tillich. Thank you guys for taking the questions.

Thanks so much, Jim.

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.