Acurx Pharmaceuticals, Inc. (ACXP) Q4 2024 Earnings Report, Transcript and Summary

Greetings and welcome to the Acurx Pharmaceuticals Fourth Quarter and Full Year 2024 Financial Results and Business Update. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I'll now turn the conference over to your host Mr. Robert Shawah, Chief Financial Officer for Acurx Pharmaceuticals. 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 fourth quarter and full year 2024, 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 fourth quarter and full year ended December 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-K, which we filed yesterday Monday, March 17th, 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, March 18th, 2025. 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 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 of '24 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, ibezapolstat or IBZ as we call it, for the treatment of C. difficile infection into international Phase 3 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 US 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 Drs. Garey and Eubank from the University of Houston School of Pharmacy presented a scientific poster showing that in our Phase 2b clinical trial, ibezapolstat had comparable clinical cure and sustained clinical cure rates and safety profile to vancomycin. As previously reported, the overall observed clinical cure rate in the combined Phase 2 trials, Phase 2a and Phase 2b in patients with CDI was 96% 25 out of 26 patients and importantly 100% or 25 of 25 of the IBZ-treated patients in the Phase 2 program who had clinical cure at the end of treatment remained cured through one month after EOT as compared to just 86%, 12 of 14 patients in the vancomycin treatment arm in Phase 2b. Also in a subset of ibezapolstat patients, five of five followed for three months after the end of treatment experienced no recurrence of infection. IBZ-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 Dr. Garey, these exciting results demonstrate two properties of ibezapolstat, 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 ibezapolstat-treated patients, providing another important mechanism to prevent recurrent CDI. In November last year, we announced sponsorship and participation in the inaugural Peggy Lillis Foundation CDI Scientific Symposium and presented an ibezapolstat Phase 2b clinical data update. In January '25, the company announced it had closed the $2.5 million 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 ibezapolstat Phase III clinical trial program, which guidance is aligned with FDA on matters of manufacturing, non-clinical and clinical aspects of the Phase 3 program. The EMA guidance also confirmed ibezapolstat's regulatory pathway for a marketing authorization application to be filed by the company after successful completion of the Phase 3 clinical trials. So now with mutually consistent feedback from both the EMA and FDA, Acurx is well positioned to commence our international Phase 3 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 non-clinical studies, which we believe can leverage to show further positive differentiation for competitive advantage of IBZ 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 IBZ 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 Dr. Justin McPherson 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 IBZ for treating C. difficile infection. Our scientific advisors consider this to be a major finding, which provides a mechanistic explanation for ibezapolstat's selectivity in that the predicted bactericidal interaction between IBZ and its target, the DNA pol IIIC enzyme, allows regrowth of gut microbes known to confer health benefits. The second study conducted by Dr. Trenton Wolfe from the University of Montana was funded by NIAID, the National Cancer Institute, National Center for Advancing Translational Sciences and the Company. This second study is the first ever head-to-head comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin or metronidazole-treated groups, complementing prior Phase 2 findings showing ibezapolstat's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of ibezapolstat and the fidaxomicin-treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies. These results establish ibezapolstat'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 alteration compared to fidaxomicin. Also in February '25, last month, the Japanese Patent Office granted a new patent for our DNA polymerase IIIC inhibitors, which expires in December 2039 subject to extension. This constitutes a significant building block for our ongoing development of ACX-375C, our pre-clinical antibiotic candidate, targeting the treatment of MRSA, VRE and Anthrax infections. On March 10th, just a week ago, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million. We continue to identify and pursue funding opportunities for our Phase 3 clinical trial program. We have several initiatives underway to that end and hope to have subject to report in future updates. So now we've got even more momentum going into 2025 and beyond. As we have continually reported, IBZ clinical results continue to outperform in a serious and potentially life-threating infectious disease caused by C. difficile bacteria that the CDC categorize as an urgent threat and calls for new classes of antibiotics for initial treatment, but also have a low incidence of recurrence. From a regulatory perspective, FDA has granted IBZ, QIDP and Fast Track designations for the treatment of C. difficile infection. We also believe that ibezapolstat, if approved, to make a favorable economic impact by reducing the overall annual cost burden in the US for C. difficile infection. $5 billion annually, of which $2.8 billion is due to recurrent infection. And 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 Shawah, 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 December 31, 2024, were included in our press release issued earlier this morning. The company ended the year with cash totaling $3.7 million compared to $7.5 million as of December 31, 2023. The company raised a total of $6.6 million of gross proceeds under its ATM financing program for the year ended December 31, 2024. Research and development expenses for the three months ended December 31, 2024 were $0.8 million compared to $1.9 million for the three months ended December 31, 2023, a decrease of $1.1 million. The decrease was primarily due to a decrease in consulting related costs of $1.2 million offset by an increase in manufacturing costs of $0.1 million. For the year ended December 31, 2024, research and development expenses were $5.4 million compared to $6 million for the year ended December 31, 2023, a decrease of $0.6 million. The decrease was primarily due to a $1.6 million decrease in consulting related costs, offset by a $1 million increase in manufacturing-related costs. General and administrative expenses for the three months ended December 31, 2024 were $2 million compared to $3.2 million for the three months ended December 31, 2023, a decrease of $1.2 million. The decrease was primarily due to a $0.5 million decrease in professional fees, a $0.5 million decrease in share-based compensation costs and a $0.2 million decrease in employee compensation costs. For the year ended December 31, 2024, general and administrative expenses were $8.7 million compared to $8.5 million for the year ended December 31, 2023, an increase of $0.2 million. The increase is primarily due to a $0.7 million increase in professional fees, a $0.3 million increase in legal fees, offset by a $0.6 million decrease in share-based compensation costs and a $0.2 million decrease in insurance costs. The company reported a net loss of $2.8 million or $0.16 per diluted share for the three months ended December 31, 2024 compared to a net loss of $5.1 million or $0.37 per diluted share for the three months ended December 31, 2023. Net loss of $14.1 million or $0.87 per share for the full year ended December 31, 2024 compared to a net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023, all for the reasons previously mentioned. The company had 17,030,686 shares outstanding as of December 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?

[Operator Instructions] 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 Thomas Yip asking a couple of questions for Ed. Thank you so much for taking our questions.

Thank you, Thomas. Good morning.

Good morning. So first question for the Phase 3 program. Can you discuss some notable differences and also similarities between what the FDA and the EMA are looking forward to the Phase 3?

It's identical, Thomas. We're so fortunate in that regard. We waited 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 from both agencies.

Okay. So in that vein, how do you envision the Phase 3 program will enroll patients geographically? Would it be like a specificity split between the US and the EU or how do you envision to proceed?

Well, subject to the normal adjustments that you may call inaudibles 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 US, Canada and South America. I guess you can say by a plurality it will 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 see. I got it. And then moving on to additional data that you have been presenting either in at conferences or publications. So after this microbiome study data that were published in last month, when should we expect more data with ibezapolstat 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 2 data will be included and published. And we think that will be sometime in the next 30 days. So that's the next one, but 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 also up in Montana.

Okay. Understood. We'll look forward to that. And then perhaps one final question from us. What options do you have available to fund development of 375 into the clinic?

So we haven't taken any options off the table. Obviously, we're continuing our multistep approach to funding the company and most importantly, the Phase 3 trial. As I see it, with 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 US. So I think those aspects of kind of our activities are kind of in the forefront, at least for right now, while we continue to pursue private partnerships and M&A activity. That seems to be less active than the responses we're getting from some of the government and quasi 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 no recurrences.

Understood. If I may just one additional question actually. Just wonder if your plan is still to look for a partnership to move ibezapolstat into Phase 3 or is there 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 in a broad sense, yes, that's still the plan.

Okay. Understood. Thank you so much for taking the questions. Looking forward to the --

Thank you so much, Thomas.

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

Hey, guys. Thanks so much for taking --

Good morning, James.

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. So has that impacted your ability to secure partnerships? Is this something you think will happen 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 3s, but I guess that depends quite a bit upon either a partnership or funding events, right?

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 kind of further along at this point than private sector partnerships, but we're continuing our efforts in both regards. I have been to Washington D.C. on Capitol Hill several times now. And I can tell you firsthand that everyone is looking over their shoulder down there right now. And it's a different vibe than I experienced when I was down in Capitol Hill back in September. So 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 continuing the process. I think something will happen in 2025 that will allow us to start the Phase 3 trials with enrollment. There may be a time lag between that event and the enrollment starting just because we don't want to make our fill finish pill form until we're certain to have the money to start the trial because we don't want to date the packages before we have to. So that's the final step and that will 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. Does that answer your question, Jim?

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

Yes. Well, so the interim look, we decided against the interim look because statistically, 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 keep enrolling or futility. We wouldn't be able to see any of the numbers, 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 question. Thank you very much for taking.

Excellent. I hope you enjoyed your holiday yesterday.

Did you have the calls, not on the day at the St. Patrick's Day?

Thank you. [Operator Instructions] Our next question comes from the line of Claire Acheson with Independent Investment Research. Please proceed with your question.

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 reactivated it, so to speak, when the company management decides to do that. So there's no prohibition on us reactivating the ATM. It's currently not part of our ongoing plan, which will unfold over the next several months. But with the delisting, I could tell you, Claire, that there's no sense internally that we'll let the NASDAQ listing go. And we're working on some things which we think will help with the listing in that regard. So we're -- leave it 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 confident you'll be able to manage that?

Yes. Absolutely.

Okay, great. Thank you.

Thank you, Claire.

Thank you. Ladies and gentlemen, this concludes our question-and-answer session and will conclude our call today. We thank you for your interest and participation. You may now disconnect your lines.

Thank you, Melissa.

Thank you.