Acurx Pharmaceuticals, Inc. Price & Performance (ACXP)

Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the fourth quarter and full year of 2024. Is available on our website. At accurexpharma.com. Joining me today is Dave Lucci, 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 fourth quarter and full year ended 12/31/2024, 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 ks which we filed yesterday Monday, 03/17/2025. 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, 03/18/2025. I'll now turn the call over to Dave Lucci. Dave? Thanks, Rob. Morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and full year 2024 and also to hear some recent updates. Then 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 'twenty four. Or in some cases shortly thereafter. Which have been the most significant in our company's history. As we are now finalizing preparation to advance our lead antibiotic candidate, ibezaflozat or IVET. As we call it, for the treatment of C. Difficile infection. Into international Phase III clinical trials. We believe that if successful, this last set of clinical trials to complete will be pivotal to form the basis for our new drug application in The U. S. And marketing authorization application for the European Union. In October 24, we exhibited at ID Week in Los Angeles. Which was the Annual Scientific Conference of the Infectious Disease Society of America where doctors Gary and Eubank from the University of Houston School of Pharmacy presented a scientific poster showing that in our Phase IIb clinical trial, IVET is at comparable clinical cure and sustained clinical cure rates and safety profile to vecromycin.

As previously reported, the overall observed clinical cure rate in the combined Phase two trials Phase IIa and Phase IIb in patients with CEI, was ninety six percent, twenty five out of twenty six patients and importantly, one hundred percent or twenty five of twenty five of the I BEST treated patients in the Phase II program who had clinical cure at the end of treatment remains cured. Through one month after EOT. As compared to just eighty six percent twelve of fourteen patients in the vancomycin treatment arm. In Phase 2b. Also, in a subset of ipazepulstat patients, five of five follow for three months after the end of treatment. Experienced no recurrence of infection. IVES treated patients showed decreased concentration of fecal primary bile acids and higher ratios of secondary to primary bile acids than vancomycin treated patients. According to Doctor. Gary, these exciting results demonstrate two properties of which may contribute to its anti recurrence effect. First, the preservation and restoration of beneficial bacteria classes in the gut provide resistance to recolonization by C. Difficile. Second, these data presented for the first time indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ifazepulstat treated patients providing another important mechanism to prevent recurrent CDI.

In November, we announced sponsorship and participation in the inaugural Peggy Willis Foundation CDI Scientific Symposium. And presented an iBezomous Phase 2b clinical data update. In January 25, the company announced it closed at $2,500,000 registered direct offering priced at the market under NASDAQ rules. Also in January 25, we announced that we received positive regulatory guidance from the European Medicines Agency for the ipazepulstat Phase III clinical trial program. Which guidance is aligned with FDA on matters of manufacturing nonclinical and clinical aspects of the Phase three program. The EMA guidance also confirmed ipazepulsa's regulatory pathway for a marketing authorization application to be filed by the company after successful completion of the Phase III clinical trials. So now with mutually consistent feedback from both the EMA and FDA, Acurx is well positioned to commence our international Phase III registration program. This past February and just this month, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important nonclinical studies, which we believe can leverage to show further positive differentiation for competitive advantage of IBEST as compared with all other antibiotics used for frontline therapy to treat C. Difficile infection. And for that matter, given our clinical results to date, we're hopeful that this anti recurrence effect of IVAS could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI.

In February, we announced positive results from this first study conducted by Doctor. Justin MacPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Diseases, or NIAID, It was an in silico study that predicted the microbiome restorative potential of IVAS for treating C. Difficile infection. Our scientific advisers consider this to be a major finding which provides a mechanistic explanation for ibezapulstat selectivity. And that the predicted bactericidal interaction between IVAS and its target the DNA POL3C enzyme, allows regrowth of gut microbes known to convert health benefits. The second study conducted by Doctor. Trenton Wolf the University of Montana was funded by NIAID the National Cancer Institute, National Center for Advancing Translational Sciences, and the company. The second study is the first ever head to head comparison of gut microbiome changes. Associated with IPEVS when compared to other anti CDI antibiotics in a germ free mouse model The data show that changes in alpha and beta microbiome diversities following IVET's treatment were less pronounced compared to those observed in vancomycin or metronidazole treated groups. Complementing prior Phase II findings [indiscernible] anti antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of abezoprostat and the fidaxomicin treated groups.

Which may allow for differentiation of these two anti CDI antibiotics in future studies. These results establish idezepulostat's differentiating effects on the gut microbiome indicating a more selective spectrum of microbiome alteration. Compared to broader spectrum antibiotics like vancomycin and metronidazole. And a narrower spectrum of microbiome alterization compared to [indiscernible] Also on February, the Japanese patent office granted a new patent for our DNA polymerase 3C inhibitors. Which expires in December 2039 subject to extension. This constitutes a significant building block for our ongoing development of ACX-three seventy five C our preclinical antibiotic candidate targeting the treatment of MRSA VRE, and anthrax infections. On March 10, just a week ago, we announced the closing of our registered direct offering and concurrent private placement raising gross proceeds of 1,100,000.0 We continue to identify and pursue funding opportunities for our Phase three clinical trial program. We have several initiatives underway to that end, and hope to have something to report in future updates. So now we've got even more momentum going into 02/2025 and beyond. As we've continually reported IVAS clinical results continue to outperform in a serious and potentially life threatening infectious disease caused by Acetavacil 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. From a regulatory perspective, FDA has granted IBEST QIDP and Fast Track designations. For the treatment of C. Difficile infection. We also believe that ipenopulcet, if approved, could make a favorable economic impact by reducing the overall annual cost burden in The U. S. For C. Difficile infection dollars 5,000,000,000 annually, of which $2800000.02800000000.0 dollars is due to recurrent infection. And that that's what our data shows we may solve for. With our continuing momentum and passion to achieve success for our stakeholders, we do believe the best is yet to come. And now back to our CFO, Rob Shalwa. To guide you through the highlights of our financial results for the fourth quarter and full year 2024. Rob? Thanks, Dave. Our financial results for the fourth quarter and year ended 12/31/2024, were included in our press release issued earlier this morning. The company ended the year with cash totaling $3,700,000 compared to $7,500,000 as of 12/31/2023, The company raised a total of $6,600,000 of gross proceeds under its ATM financing program. For the year ended 12/31/2024. Research and development expenses for the three months ended 12/31/2024, were $800,000 compared to $1,900,000 for the three months ended 12/31/2023.

A decrease of $1,100,000 The decrease was primarily due to a decrease in consulting related costs of $1,200,000 offset by an increase in manufacturing costs of $100,000 For the year ended 12/31/2024, research and development expenses were $5,400,000 compared to $6,000,000 for the year ended 12/31/2023. A decrease of $600,000 The decrease was primarily due to a $1,600,000 decrease in consulting related costs, offset by a $1,000,000 increase in manufacturing related costs. General and administrative expenses for the three months ended 12/31/2024, were $2,000,000 compared to $3,200,000 for the three months ended 12/31/2023, a decrease of $1,200,000 The decrease is primarily due to a $05,000,000 decrease in professional fees a $05,000,000 decrease in share based compensation costs, and a $200,000 decrease in employee compensation costs. For the year ended 12/31/2024, general and administrative expenses were $8,700,000 compared to $8,500,000 for the year ended 12/31/2023. An increase of $200,000 The increase was primarily due to a $700,000 increase in professional fees a $300,000 increase in legal fees, offset by a $600,000 decrease in share based compensation costs and a $200,000 decrease in insurance costs. The company reported a net loss of $2,800,000 or $0.16 per diluted share for the three months ended the third December thirty one, twenty twenty four.

Compared to a net loss of $5,100,000 or $0.37 per diluted share for the three months ended 12/31/2023. And a net loss of $14,100,000 or $0.87 per share for the full year ended 12/31/2024, compared to a net loss of $14,600,000 or $1.15 per share for the year ended 12/31/2023. All for the reasons previously mentioned. The company had 17,030,686 shares outstanding. As of 12/31/2024. With that, I'll turn the call back over to Dave. Thanks, Rob, and to all of you for joining us today. I'll now turn the call over to Melissa, our operator, to open the call for questions. Melissa?

Thank you. Before pressing the star keys. Our first question comes from the line of Ed Arce with H. C. Wainwright. Please proceed with your question.

Hello. Good morning, everyone. This is Tom Vazib asking a of questions for Ed. Thank you so much for taking our questions. Thank you, Thomas. Good morning. First, So first question for the Phase III program, Can you discuss some notable differences and also similarities between what the FDA and the EMA are looking for for the Phase three? It's identical, Thomas. We're we're so fortunate in that regard. We waited and part of it is strategy. We didn't go to the European Medicines Agency until we had cleared all of the nonclinical, clinical and manufacturing aspects with the FDA. So only with that in hand, we went with a final package to the Europeans And it's an identical protocol. There's complete agreement in all regards for both agencies.

Okay.

So in that vein, how do you envision the Phase III program will enroll patients geographically? Will it be like a fiftyfifty split between The U. S. And the EU? Or how do you envision to proceed? Well, subject to the normal adjustments that you make calling audibles along the way, we're going to start out with 150 clinical trial sites. And a full half of those sites will be in Europe, and the other half will be a combination of U. S. Canada and South America.

Okay.

I guess you could say, by a plurality, it'll be more European than American. Maybe there'll be 30% of the sites in The US compared to 50% of the sites in Europe.

I got it. And then and then moving on to additional data that you have been presenting, you know, either in at conferences or publications? So after this microbiome study data that were published last month, when should we expect more data with this post this year? That's a very poignant question. Thanks for asking. There is a very prestigious scientific publication within which our full set of Phase II data will be included and published. And we think that will be sometime in the next thirty days.

Okay.

So that that's the next one, but they they they appear periodically. There's continually more and more data coming out from what we've already done. From the labs at the Houston College of Pharmacy and and also up in Montana.

Okay. Understood. Well, we'll look forward to that. And then perhaps one final question from us. What options do you have available to fund development of three seventy five into the clinic?

So we haven't taken any options off the table Obviously, we're continuing our multi step approach to funding the company and most importantly, the Phase III trial. As I see it, with the funding opportunities, I see the most likely opportunities with partnerships or grants, if you will, with government bodies or quasi government bodies either in Europe or in The U. S? So I think those aspects of you know, kind of our activities are kind of in the forefront, at least for right now. While we continue to pursue private partnerships and M and A activity, that seems to be less active than the responses we're getting from some of the government and crazy government agencies. And I think that's because folks are recognizing as more and more of our data gets out there, that we have a real drug that has a real need And not only would it be good for the public to have this available frontline for C. Difficile, but it would be quite beneficial for the cost of public health because of the the no recurrences.

Understood.

If I may, just one additional question, actually. Just wonder if your plan is still to look for a a partnership to move It does supposed to end phase three or as as the other options as well?

Yes. I mean, we're looking for a partnership, but remember, we use the term partnership broadly to include a number of different agencies of the government along with the private sector. So a broad sense, yes, that's still the plan.

Okay. Understood. You so much for the kind of questions.

Thank you so much, Thomas.

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

Good morning. Thank you very much for taking my questions.

Of course.

I was just wondering if you could characterize the partnership environment I know there's a lot of turmoil in the market. Has that impacted your ability secure partnerships? Is this something you think will happen in the in the 2025 time frame, or is this a 2026 event And sort of if you have any and I know that perhaps that leads into the next question, when do you think you'll start the Phase three? But I guess that depends quite a bit upon either a partnership or a funding of entry.

Yes. I agree and I agree. The tumultuous nature of the things happening in the world today certainly present an even more keen challenge than we were facing coming into '25. But we feel that we're up for the challenge, and we're going to continue to fight I do see potential partnerships with various groups throughout the world that are not pharmaceutical companies as being you know, kind of further along at this point than than private sector partnerships. But we're continuing our efforts in both regards. I have been to Washington DC on Capitol Hill several times now. And I can tell you firsthand, that everyone's looking over their shoulder down there right now. And you know, it's a different vibe than I experienced when I was down in Capitol Hill back in September. So you know, hopefully, things settle down over the next couple of months and we can get down to some appropriations. But there are still appropriations from prior approvals government approved programs, that we're chasing down and in one case have applied for. So we're we're continuing the process I think something will happen in 02/25. That will allow us to start the phase three trials with enrollment.

There may be a time lag between you know, that event and the enrollment starting. Just because we don't wanna make our fill finish pill form until we're certain to have the money to start the trial. Because we don't we don't wanna date the packages. Before we have to. So that's the final step. And that'll take place after the money comes in. So that may present a few months time lag between having the sufficient funding and starting the enrollment. That answer your question, Jim?

It does indeed. I know there's a lot of uncertainty on these things, of course. The should you get this trial started, what is the expect what's the current expectation for soup to nuts have a top line data or an inter interim look? When do you think that that could occur should the the trial start, you know, tomorrow?

Yes.

Well, so the interim look, we we decided against the interim look because [indiscernible] it adds like 10% to the required number of patients in the trial. And it wouldn't really provide us anything other than an advisory committee would tell us you know, keep enrolling or you know, futility. You know, we wouldn't be able to see any of the numbers. Know, it being a double blind study. So we didn't do the interim look, but I think it would be two years from first patient enrolled to top line data.

All right. Excellent. That wraps up my questions. Thank you very much for taking it.

Excellent. I hope you enjoyed your holiday yesterday.

Could you have the calls not on the day of Saint Patrick's Day?

Thank you. Ladies and gentlemen, those are Our next question comes from the line of Claire Acurxson with Independent Investment Research. Good morning, gentlemen.

Good afternoon, Claire.

Just a couple of things for me. I just noticed that you've made mention of the suspension of the ATM program in January. I was just wondering if you could talk a little bit about what's happening there. And then also, if you could just comment on the risk with the NASDAQ listing given where the share price is currently trading?

Sure.

So we suspended the ATM in connection with the offering that we were conducting in January. And we can put the ATM back in place and you know, reactivate it, so to speak. When the company management decides to do that. So there's no prohibition on us reactivating the ATM. You know, it's currently not part of our you know, ongoing plan. Which will unfold over the next several months, But, you know, with the with the delisting, I can tell you, Claire, that there's you know, no sense internally that we'll let them NASDAQ listing go. And we're working on some things which we think will help with the listing in that regard. So you know, we're legal with us for now, but the last thing I would expect to see is for us to be traded out of the bulk of the way.

Okay. So you're you're confident you'll be able to manage that? Oh, yes. Absolutely.

Okay. Great. Thank you.

Thank you, Claire.

Thank you.

Ladies and gentlemen, this 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.

Thank you, Melissa.

Thank you.