Acurx Pharmaceuticals Q4 2024 Earnings Report

Acurx Pharmaceuticals EPS Results

• Actual EPS: -$0.16
• Consensus EPS: -$0.18
• Beat/Miss: Beat by +$0.02
• One Year Ago EPS: N/A

Acurx Pharmaceuticals Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Acurx Pharmaceuticals Announcement Details

• Quarter: Q4 2024
• Date: 3/17/2025
• Time: Before Market Opens
• Conference Call Date: Tuesday, March 18, 2025
• Conference Call Time: 8:00AM ET

Acurx Pharmaceuticals (NASDAQ:ACXP), a clinical stage biopharmaceutical company, develops antibiotics to treat bacterial infections. The company's lead antibiotic candidate is ibezapolstat, a novel mechanism of action that targets the polymerase IIIC enzyme that is in Phase 2b clinical trial to treat patients with clostridium difficile infections. It also develops ACX-375C, a potential oral and parenteral treatment targeting gram-positive bacteria, including methicillin-resistant staphylococcus aureus, vancomycin-resistant enterococcus, and penicillin-resistant streptococcus pneumonia. Acurx Pharmaceuticals, Inc. was incorporated in 2017 and is headquartered in Staten Island, New York.

Acurx Pharmaceuticals Q4 2024 Earnings Call Transcript

Presentation

[Operator]

Greetings, and welcome to the Acctric Pharmaceuticals Fourth Quarter and Full Year twenty twenty four 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. As a reminder, this conference is being recorded. I'll now turn the conference over to your host, Mr.

[Operator]

Rob Shallow, Chief Financial Officer for Acrux Pharmaceuticals. Please go ahead, sir.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

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 acorexpharma.com. Joining me today is Dave Lucci, President and CEO of Acorex, 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.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

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 AcuraX 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.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

Dave?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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 twenty 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, abezoprostat or IVET as we call it, for the treatment of cetacell infection into international Phase three clinical trials.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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 League in Los Angeles, which was the annual scientific conference of the Infectious Disease Society of America, where doctors Gary and Yubank from the University of Houston School of Pharmacy presented a scientific poster showing that in our Phase 2b clinical trial, I bet that comparable clinical cure and sustained clinical cure rates and safety profile to vecomycin. As previously reported, the overall observed clinical cure rate in the combined Phase two trials, Phase 2a and Phase 2b in patients with CDI was ninety six percent, twenty five out of twenty six patients and importantly one hundred percent or twenty five of twenty five of the IVAS treated patients in the Phase two 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 zagromycin treatment arm in Phase 2b.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Also in the subset of ipadipol fat patients, five zero five followed for three months after the end of treatment experienced no recurrence of infection. Ibex treated patients showed decreased concentration of fecal primary bile acids and higher ratio of the secondary to primary bile acids than vancomycin treated patients. According to Doctor. Gary, these exciting results demonstrate two properties of ipadipol fat, 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.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Difficile. Second, these data presented for the first time indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ipadipolxat treated patients, providing another important mechanism to prevent recurrent TDI. In November, we announced sponsorship and participation in the inaugural Peggy Willis Foundation CDI Scientific Symposium and presented my Besapol for Phase 2b clinical data update. In January 2025, the company announced that it closed a $2,500,000 registered direct offering priced at the market under Netatype rules. Also in January 2025, we announced that we received positive regulatory guidance from the European Medicines Agency for the atezepulcet Phase III clinical trial program, which guidance is aligned with FDA on matters of manufacturing, non clinical and clinical aspects of the Phase three program.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

The EMA guidance also confirmed as a full fledged regulatory pathway for our marketing authorization application to be filed by the company after successful completion of the Phase three clinical trials. So now with mutually consistent feedback from both the EMA and FDA, Accorex is well positioned to commence our international Phase three registration program. This past February and just this month, we announced new publications in the Journal of Antimicrobial Agents and Chemo Theracutis, two very important non clinical studies, which we believe can leverage to show further positive differentiation for competitive advantage of Ibanez 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 IVET could mitigate the need for expected microbiome therapeutic agents to prevent recurrent CDI.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

In February, we announced positive results from this first study conducted by Doctor. 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 restored its potential of IVAS for treating C. Difficile infection. Our scientific advisors consider this to be a major finding, which provides a mechanistic explanation for either the forecast selectivity and that the predicted bacterial cidal interaction between I BEST and its target, the DNA polycythe enzyme, allows regrowth of gut microbes known to confer health benefits.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

The second study conducted by Doctor. Trenton Wolf from the University of Montana was funded by NIAID, the National Cancer Institute, National Center for Advanced Translational Sciences and the company. The second study is the first ever head to head comparison of gut microbiome changes associated with I BEST 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 I BEST treatment were less pronounced compared to those observed in metamycin or metronidazole treated groups, complementing prior Phase II findings showing IVEST has more selective anti bacterial activity. Further and very importantly, notable differences were observed between the microbiome of Afesoprostac and the fidaxomicin treated groups, which may allow for differentiation of these two anti CDI antibiotics in future studies.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

These results established adenoclonal fat differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to the broader spectrum antibiotics like vancomycin and metronidazole and an average spectrum of microbiome ulcerization compared to venaxomycin. Also on February, the Japanese Patent Office granted a new patent for our DNA, Glenray 3C inhibitors, which expired in December 2039, subject to expansion. This constitutes a significant building block for our ongoing development of APX375C, 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 a registered direct offering and concurrent private patient, raising gross proceeds of $1,100,000 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.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

So now we've got even more momentum going into 2025 and beyond. As we've continually reported, Ivette Clinical results continue to outperform in a serious and potentially life threatening infectious disease caused by Acetylacile bacteria that the CDC categorized 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 Ives, QIDP and Fast Track designations for the treatment of C. Difficile infection. We also believe that Ivesoploafide, if approved, can make a favorable economic impact by reducing the overall annual cost burden in The U.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

S. For C. Difficile infection, dollars five billion annually, of which $2,800,000,000 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 Schaller, to guide you through the highlights of our financial results for the fourth quarter and full year 2024.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Rob?

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

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.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

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 $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 $500,000 decrease in professional fees, a $500,000 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 is 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.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

The company reported a net loss of $2,800,000 or $0.1.0.16 dollars per diluted share for the three months ended 12/31/2024 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.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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.

[Operator]

Our first question comes from the line of Ed Arcey with H. C. Wainwright. Please proceed with your question.

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

Hello. Good morning, everyone. This is Timothy asking a couple of questions for Ed. Thank you so much for taking our questions. And

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

the first

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

question for the Phase three program, can you discuss some notable differences and also similarities between what the FDA and the EMA are looking for, for the Phase three?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

It's identical, Thomas. We're so fortunate in that regard. We waited as part of the strategy, we didn't go to the European Medicines Agency until we had cleared all of the non clinical, 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.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

It's complete agreement in all regards for both agencies.

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

Okay. So in that vein, how do you envision the Phase three program will enroll patients geographically? Would it be like a specific split between The U. S. And the EU or how do you envision to proceed?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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 U. S, Canada and South America. Okay.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

But I

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

guess you can say, by a plurality, it will be more European than American. Maybe there'll be 30% of the sites in The U. S. Compared to the 50% of the sites in Europe.

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

I see. I got it. And then moving on to additional data that you have been presenting either at conferences or publications. So after this microbiome study data that were published in last month, when should we expect more data with the data this year?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

That's very poignant question. Thanks for asking. There is a very prestigious scientific publication within which our full set of Phase two data will be included and published. And we think that will be sometime in the next thirty days. Okay.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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.

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

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 $3.75 into the clinic?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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 three 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 U. S. So I think those aspects of our activities are kind of in the forefront, at least for right now.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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 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 front line for seed at the field, but it would be quite beneficial for the cost of public health because of the no recurrences.

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

Understood. Stefan, just one additional question actually. Just wonder if your plan is still to look for a partnership to move to better post that into phase three or as the other actions as well?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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, yes, that's still the plan.

[Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC]

Okay, understood.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

Thank you so much for the kind of questions.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Thank you so much, Tommy.

[Operator]

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

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

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

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Correct.

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

I was wondering

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

if you could characterize the partnership environment and 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 timeframe or is this a twenty twenty or six 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 to Phase three? But I'm guessing that depends quite a bit upon either a partnership or a funding adventure.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

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 2025. 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.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

But we're continuing our efforts in both regards. I 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 Chapel 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.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

But there are still appropriations from prior approvals, government approved programs that we're chasing down in one case we have applied for. So we're we're continuing the process. I think something will happen in June of twenty five, that will allow us to start the Phase three trials with enrollment. There may be an inelapse 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 want to date the packages before we have to. So that's the final step and that'll take place after the money comes in.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

So that may present a few months time lag between having the sufficient funding and starting the enrollment. Does that answer your question, Ed?

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

It does indeed. And there's a lot of uncertainty on these things, of course. Should we 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?

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Yes. Well, so the interim look, we decided against the interim look because statistically, it has like ten percent 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 futility. You know, we wouldn't be able to see any of the numbers, it being a double blind study. So we didn't do year end look, but I think it will be two years from first patient enrolled to top line data.

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

Alright. Excellent. That wraps up my question.

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

Thank you

[James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners]

very much for taking.

[David Luci, Co-Founder, President, CEO, Corporate Secretary & Director at Acurx Pharmaceuticals]

Excellent. I hope you enjoy your holiday yesterday.

[Operator]

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

[Analyst]

Good morning, gentlemen.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

Good afternoon, sir.

[Analyst]

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 lifting given where the share price is currently trading?

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

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 reactivate it, so to speak, when the company management decides you know, to 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.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

But, you know, with the with the deal I think, I can tell you, Claire, that there's, you know, 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 leaving with us for now, but the last thing I would expect to see is for us to be traded out of the bulk of US.

[Analyst]

Okay. So you're confident you'll be able to manage that? Yes, absolutely. Okay, great. Thank you.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

Thank you, Claire.

[Operator]

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.

[Robert Shawah, Co-Founder & CFO at Acurx Pharmaceuticals]

Thank you, Melissa. Thank you.

Participants

Executives

• Robert Shawah, Co-Founder & CFO
• David Luci, Co-Founder, President, CEO, Corporate Secretary & Director

Analysts

• Thomas Yip, Research Associate at H.C. Wainwright & Co., LLC
• James Molloy, Managing Director, Senior Biotechnology & Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners
• Analyst