Acurx Pharmaceuticals (NASDAQ:ACXP) Q2 2026 Earnings Call

0:00 Greetings. Welcome to Acurx Pharmaceuticals to discuss Second Quarter twenty twenty six Financial Results on 08/14/2026 Conference Call and provide business update. At this time, all participants will be in listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I'll now turn the conference over to Rob Shawa, Chief Financial Officer. Thank you. You may begin. Thank you, Rob. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the second quarter of twenty twenty six, which is available on our website at acurxpharma.com.

0:47 Joining me today is Dave Lucey, 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 second quarter ended June 30 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 yesterday, Thursday, 08/13/2026.

1:41 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, August 14. 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 second quarter and also to hear some recent updates on our continuing progress. Then we'd be pleased to take any questions. Our Executive Chairman, Bob DeLucia and our Medical Director, Doctor. Michael Silverman have joined us today and will be available to answer questions about our recent FDA meeting and our clinical development plan for ibezapulstat, both in recurrent C. Diff infection and in acute CDI.

2:37 First, I'd like to briefly summarize just a few of our key activities for the second quarter of twenty twenty six or in some cases, shortly thereafter. Last month, in July 2026, the company's research and development team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single Phase III study in acute CDI and its acceptability as a pivotal trial for filing a new drug application, the outcome of which we provided more detail in our August 3 press release. Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the ipasifolstat clinical development program at a pre NDA meeting after completion of a single Phase III trial called IBAZ ASPIRE and any other clinical trials conducted prior to the pre NDA meeting, which will include the Pathfinder study, 20 patients open label in recurrent CDI, particularly if the clinical efficacy results are robust.

3:44 As you may recall from our previous announcements, we've begun startup activities to conduct the 20 patient groundbreaking Pathfinder study and mostly recurrent CEI, with enrollment anticipated to start in the fourth quarter. This trial was acknowledged by FDA as being significant and along with robust results from our ASPIRE trial, will form the basis of a potential approval for the treatment of both CDI and for the treatment of CDI and prevention of recurrent CDI. In August 2026, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary name or brand name for ibezopolostat, which I'll share with you now is Cifbezi.

4:36 These initial milestones will form the basis for the commercial identity of ibezopolostat as the company prepares to advance it towards international Phase III registration program and ultimate commercialization. Also in July, we signed and announced last week a continuation of our scientific partnership with Leiden University Medical Center to advance development of our DNA POL3C inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received from the Dutch government in November 2025. This new partnership will enable further mechanistic research into DNA POL3C inhibition to accelerate the development of novel new antibiotics that are systemically active against a wide range of gram positive pathogens resistant to currently available antibiotics.

5:34 This new research also aims to generate the first ever three d structure of policy from methicillin resistant Staph aureus and complexed with an Acurx inhibitor to advance discovery of new compounds to treat this high priority clinical pathogen as designated by the CDC and the FDA. In the same month, in July, a presentation of scientific data by Doctor. Kevin Gehry and his team from his laboratory at the University of Houston College of Pharmacy demonstrated that following treatment in his state of the art laboratory model with ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence.

6:23 In addition, IVES and Fidax, fidaxomicin, were superior in biofilm experimental models with IVES significantly more effective at killing C. Diff than vancomycin and Fidax. Acurx remains prepared to commence its Phase III clinical trial program with the ASPIRE trial for the treatment of both CDI and reduction of recurrence, pending appropriate funding from public or private sources or partnerships. Our recent progress and efforts to secure this funding are ongoing. I'd also point out that our Pathfinder trial is fully funded and if successful, will elevate the product profile of IVAS as well as provide significant supportive data for FDA's evaluation.

7:16 In April, the company announced the closing of a registered direct offering of up to $7,100,000 issuing 825,085 shares of our common stock or prefunded warrants at a purchase price of $3.3 per share, 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 1,650,000 shares of common stock. The short term warrants have an exercise price of $2.78 per share and are immediately exercisable upon issuance and will expire twenty four months following the effective date of the registration statement, registering resale of the shares of common stock underlying the short term warrants.

8:09 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 Pathfinder clinical trial in recurrent C. Diff and fund operations for at least one year. Also in April, a scientific poster showing that our new DNA, POL3C, systemically absorbed antibiotics in preclinical development to treat other gram positive infections, achieved potentially therapeutic plasma levels, and reduced MRSA tissue burden while maintaining a higher gut microbial diversity similar to baseline and distinct from linezolid. These data were presented at the thirty fifth Congress of Esteban, held in Munich, Germany.

9:00 Doctor. Birchida Beegham, research scientist in the laboratory of Doctor. Kevin Garry at University of Houston, presented the poster entitled Preclinical Microbiome Evaluation of Novel Pol C Inhibitor Compounds. Using microbiome profiling, metagenomics, the authors concluded that DNA Pol III C antibiotic compounds represent a targeted strategy to treat resistant gram positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic induced dysbiosis. Commenting on the significance of this data, Doctor. Gary from the University of Houston stated, discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health promoting bacteria in our gut microbiome is the holy grail of antibiotic development.

10:03 Initial work at the University of Houston with Acurx, novel POL3C inhibitors, has demonstrated favorable gut microbiome sparing effects. The novel findings presented at ESMOD demonstrate these positive microbiome results to be a class effect of DNA POL3C inhibitors, potentially positioning them as unique additions to the anti gram positive therapeutic armamentarium. So this work, coupled with our recently announced scientific partnership with Leiden University Medical Center, will pave the way for further rational design of novel DNA POL3C inhibitors to expand our opportunities for lead optimization in our portfolio of groundbreaking anti infective therapeutics.

10:51 With regard to our patent estate, to date, Acurx has secured six U. S. Patents and an additional 10 patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea and Mexico, all of which protect key aspects of our company's ibezapulstat and the ACX-three 75 C program targeting DNA POL3C. Additional country level patent applications remain under review. Also, significantly in the first quarter, a new patent was issued related to IVAS and it's used to treat CDI while reducing the recurrence of the infection as well as improving the health of the gut microbiome. Additional country level patent applications remain under review.

11:39 We continue to identify and pursue funding opportunities for our Phase III INSPIRE trial for the treatment of both acute CDI and a reduction of recurrence. We have several initiatives underway to this end and we'll report our progress in future updates. As we've continually reported, Iver's clinical and nonclinical results continue to outperform in a serious and potentially life threatening infectious disease caused by a C. Difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Furthermore, IVAS has FDA QIDP and Fast Track designations for treatment of CDI, as well as SME or small and medium enterprise status in The EU.

12:35 All Acurx compounds in preclinical development are FDA and Fast Track eligible, not received yet, and target positive infectious disease classified as serious threat priorities by CDC and FDA. We remain confident that while development of IBAB's competitive profile continues to evolve and strengthen, we'll continue to successfully navigate through these challenging times in our industry sector. And now back over to Rob Schauer, our CFO, to guide you through the highlights of our financial results for the second quarter of twenty twenty six. Rob? Thanks, Dave. Our financial results for the second quarter ended 06/30/2026, were included in our press release issued earlier this morning.

13:28 The company ended the quarter with cash totaling $10,700,000 compared to $7,600,000 as of 12/31/2025. During the quarter, the company raised a total of approximately $2,500,000 of gross proceeds through a registered direct offering as well as $800,000 under the equity line of credit. Research and development expenses for the three months ended 06/30/2026 were $1,100,000 compared to $500,000 for the three months ended 06/30/2025, an increase of $600,000 The increase was due primarily to an increase in manufacturing costs of $300,000 and an increase in consulting costs of $300,000 as a result of costs associated with the new recurrent CDI trial program.

14:27 For the six months ended June 30, research and development expenses are $1,400,000 compared to 1,100,000 for the six months ended 06/30/2025. The $300,000 increase was due primarily to a $100,000 increase in consulting fees and a $200,000 increase in manufacturing costs as a result of costs associated with the new recurrent CDI trial program. General and administrative expenses for the three months ended June 30 were $1,200,000 compared to $1,700,000 for the three months ended 06/30/2025, a decrease of $500,000 The decrease was primarily due to a $300,000 decrease in professional fees, a $100,000 decrease in legal costs and a $100,000 decrease in share based compensation expense.

15:29 For the six months ended June 30, general and administrative expenses were $2,600,000 that was compared to $3,300,000 for the six months ended 06/30/2025, a decrease of 700,000 The decrease was due primarily to $300,000 decrease in professional fees, dollars 200,000 decrease in legal costs and a $200,000 decrease in share based compensation expense. The company reported a net loss of $2,300,000 or $0.53 per diluted share for the three months ended 06/30/2026. That was compared to a net loss of $2,200,000 or $1.89 per diluted share for the three months ended 06/30/2025.

16:25 For the six months ended June 30, the company reported a net loss of $3,900,000 or $1.13 per diluted share. That was compared to a net loss of $4,400,000 or $4.01 per diluted share for the six months ended 06/30/2025, all for the reasons previously mentioned. The company had 4,683,253 shares outstanding as of 06/30/2026. With that, I'll turn the call back over to Dave. Thanks, Rob, and to all of you for joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to the call our Medical Director, Doctor. Michael Silverman and our Executive Chairman, Bob DeLucia, to assist with Q and A regarding our recent FDA meeting in our abezoprololstat clinical development program.

17:26 And now back to the operator to open the call for questions. Operator? Thank you. We'll now be conducting our question and answer Thank you. And our first question is from the line of Radhika Chirripal with S and P. Please proceed with your question. Radhika, your line is open for a question. It seems like we've lost connection with Radhika.

18:17 We'll move on to our next question will be from Matthew Keller of H. C. Wainwright. Please proceed with your questions. Hey, good morning. Thanks for taking our questions. So my first one, related manufacturing. I was wondering, do you have enough API for the planned upcoming trials? And I guess, where do you stand or where do you stand potentially on manufacturing a visible set? You, Matt. Bob, would you like to Yeah, I can just respond ask question where we stand on that. We have plenty of API and also the formulated product is all ready to go to support the Pathfinder trial. And we're poised to have enough API manufacturing with appropriate dating to start the ibisopulstad aspire trial as well.

19:09 Perfect. And then a second question, if I may. Oh, go ahead. Sorry. Yep. Oh, I wanna make sure that answered your question. Oh, yeah. Yeah. And the second question, I guess, if I may. Again, you you guided that the ASPIRE trial will be an international trial. I was wondering what geographies you guys are considering and if you've begun sort of activities in those regions for that trial. Yes, I can answer that as well too. Mike, are you on the line? You can join in just to give an idea of the scope of the trial internationally. Well, the plans are international. I don't have my finger on the pulse of every country that we've considered, but certainly Western and Eastern Europe.

19:57 I don't know. Bob, please please expand if you can. Yeah. Do you need we can follow-up with the details of the country, but we haven't begun screening for that yet. But it will be all inclusive of those countries that we know have generally high incidence of C. Difficile infection, obviously. Yep. No, makes sense. Thank you very much, guys. Thank you. Our next questions are from the line of James Molloy of Alliance Global Partners. Please proceed with your question. Good morning, James. Good morning. Thank you very much for taking my question. The one of the things you guys highlighted on August 30, you touched on the FDA is also may if the data is robust enough, may give you induction as well as a maintenance of remission.

20:52 Is can you walk through sort of what constitutes a reduction of remission? What what constitutes sort of robust enough data? I know the FDA won't guide to that exactly. But in your in your mind, what gives you guys coming out of the Pathfinder trial and going into ASPIRE? What's your target to And talk about some of FDA's interactions regarding that, please. Yeah. This is Bob. I'll let Mike join in. Meeting, At we laid out the parameters as to what would constitute robust. And Mike, you wanna go over those? Yeah. Thanks for the question. As you say, it's not something that can be specifically prescribed. But as Bob said, we proposed a number of potential criteria based on good clinical practices and also various FDA guidances.

21:43 I like to think about the support of the robustness in two general categories. One are these items that we would naturally build into a clinical trial, good clinical practice, high quality data, minimization of protocol violations, minimization of missing data, those sorts of things to ensure that the data are trustworthy. Activities, your second bucket of criteria would be those things that are inherent in the drug. Consistency of efficacy data across all of our endpoints, across all of our trial sites, across all of our countries, and I think this gets back to the previous question, we also need to ensure that our patient population is representative of the kinds of patients we would see in The United States. We do an international trial.

22:41 We have to have an eye on clinical practice and clinical guidelines that are applicable in The United States. Those are the sorts of things that we're building into this trial. I hope that helps. Yeah. You know, just to build on that a little bit. Thank you, Mike and Bob. One of the features of this new ASPIRE trial design is to measure the patients an extraordinary amount of time after the end of treatment, eight weeks after the end of treatment, which, you know, we don't know that that's been done before, but I think that also speaks to the robustness of the data. So if you're seeing no reinfection eight weeks after the end of treatment in a patient population that's had three or more prior episodes in the past year, we think the FDA will find that to be persuasive.

23:42 I guess, yeah. If what's what's sort of the the bogey with with VANCO that you're trying to trying to beat, assuming, you know, you do have some, of course. But how how much better than VANCO do you think the FDA will say that's robust? Yeah. In terms of it's another good point, which is the statistical significance of the results. This is not a superiority trial. This is a non inferiority trial. So we don't have to show superiority over vancomycin for the clinical cure, acute treatment endpoint. We need to show noninferiority within standard bounds, which is a statistical constant, but the lower limit would be confidence interval within 10%. That's a non inferiority approach.

24:32 Excellent. And then maybe final final question for me would be, I know that the Pathfinder is first. I think you've guided to maybe a year, year and a half to enroll. How much is and you go to the ASPIRE trial, certainly the final potentially pivotal trial, how important is the Pathfinder data for potential partnership to help fund the Phase III ASPIRE trial down the road? We think that's quite important. We're heartened by the FDA's enthusiasm with our being willing to conduct that trial. Now interestingly, whether or not the ASPIRE trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C. Diff.

25:28 So if we finish the 20 patient exploratory trial open label that we call Pathfinder, we will meet with the FDA and we have the possibility to be considered an LPD AD pathway program, which would make us give us the ability to file for approval in recurrent C. Diff with just one Phase three trial, which may be somewhere in the neighborhood of half the price of one of the ASPIRE trials. Yeah. I agree with you, Dave. That's important. Very important. Okay. That's all my questions. Thank you very much.

26:15 Thank you, James. Thank you. This now concludes our question and answer session. And ladies and gentlemen, this also concludes today's conference. We thank you for your participation. Have a wonderful day. Thank you, Rob. Thank you.