Acurx Pharmaceuticals Q4 2024 Earnings Report

Acurx Pharmaceuticals EPS Results

• Actual EPS: -$3.20
• Consensus EPS: -$3.60
• Beat/Miss: Beat by +$0.40
• 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), headquartered in King of Prussia, Pennsylvania, is a clinical‐stage biopharmaceutical company focused on the discovery and development of novel anti‐infective therapies. The company’s research platform leverages insights into bacterial virulence regulation and quorum sensing pathways to design small-molecule candidates aimed at reducing pathogen toxicity and biofilm formation. By targeting key mechanisms of infection rather than bacterial viability alone, Acurx seeks to offer differentiated treatment options that may help address the growing challenge of antibiotic resistance.

Acurx’s lead product candidates are being developed to treat acute bacterial skin and skin structure infections (ABSSSI), including cases caused by drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA). These candidates are engineered to limit bacterial communication and toxin production, potentially enhancing host response while preserving the normal microbiome. The company advances its programs through preclinical studies with the intent to move into first-in-human trials once regulatory filings are secured.

Since its founding in the mid-2010s, Acurx has established collaborations with academic laboratories and industry partners to bolster its drug discovery efforts and accelerate preclinical development. While its operations are predominantly U.S.-based, the company aspires to serve international markets following regulatory approvals. Acurx’s management team comprises professionals with experience in infectious disease research, pharmaceutical development, and regulatory strategy, reflecting a collective commitment to addressing unmet needs in anti‐infective therapy.

Acurx Pharmaceuticals Q4 2024 Earnings Call Transcript

Key Takeaways

• Acorex is preparing to advance its lead candidate abezoprostat (iBEST) into international Phase III clinical trials with an identical protocol endorsed by both the FDA and EMA, aiming to support US NDA and EU MAA filings upon successful completion.
• In combined Phase 2 trials, iBEST achieved a 96% overall clinical cure rate and 100% sustained cure at one month post-treatment—versus 86% with vancomycin—while showing no recurrences in a three-month follow-up subset.
• Recent nonclinical publications report that iBEST preserves beneficial gut bacteria and maintains a higher secondary-to-primary bile acid ratio, suggesting a more selective microbiome impact that may reduce CDI recurrence compared to existing antibiotics.
• As of December 31, 2024, Acorex held $3.7 million in cash (down from $7.5 million in 2023) and reported a full-year net loss of $14.1 million, with R&D expenses down $600 K and G&A roughly flat year-over-year.
• The company raised approximately $3.6 million in Q1 2025 via registered direct offerings and its ATM program and is pursuing government grants and strategic partnerships to fund its upcoming Phase III trial.

Presentation

[Operator]

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. 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. I'll now turn the conference over to your host, Mr. Rob Shawah, Chief Financial Officer for Acurx Pharmaceuticals. Please go ahead, sir.

[Robert Shawah, 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 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.

[Robert Shawah, CFO at Acurx Pharmaceuticals]

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 Dave Luci. Dave?

[David Luci, President and CEO 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. We would be pleased to take any questions. First, I would like to briefly summarize just a few of our key activities for the fourth quarter of 2024, 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 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.

[David Luci, President and CEO at Acurx Pharmaceuticals]

In October 2024, we exhibited at IDWeek in Los Angeles, which was the annual scientific conference of the Infectious Disease Society of America, where Dr. Garey and [Ubag] from the University of Houston School of Pharmacy presented a scientific poster showing that in our phase II-B clinical trial, ibezapolstat has had comparable clinical cure and sustained clinical cure rates and safety profile to fidaxomicin. As previously reported, the overall observed clinical cure rate in the combined phase II trials, phase II-A and phase II-B, 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 II 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 II-B.

[David Luci, President and CEO at Acurx Pharmaceuticals]

Also, in a subset of our 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 our 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 our 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 II-B clinical data update.

[David Luci, President and CEO at Acurx Pharmaceuticals]

In January 2025, the company announced it had closed a $2.5 million registered direct offering priced at the market under Nasdaq rules. Also, in January 2025, 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 III program. The EMA guidance also confirms ibezapolstat's regulatory pathway for a marketing authorization application to be filed by the company after successful completion of the phase III clinical trials. Now, with mutually consistent feedback from both the EMA and FDA, Acurx is well-positioned to commence our international phase III registration program.

[David Luci, President and CEO at Acurx Pharmaceuticals]

This past February, and just this month, we announced new publications in the journal of Antimicrobial Agents and Chemotherapy of two very important non-clinical studies, which we believe can leverage to show further positive differentiation for a competitive advantage of IBZ as compared with all other antibiotics used for frontline therapy to treat C. difficile infection. 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.

[David Luci, President and CEO at Acurx Pharmaceuticals]

Our scientific advisors consider this to be a major finding, which provides a mechanistic explanation for ibezapolstat selectivity in that the predicted bactericidal interaction between ibezapolstat and its target, the DNA pol IIIC enzyme, allows regrowth of gut microbes known to confer health benefits. The second study, conducted by Dr. Travis Walz 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 II findings showing ibezapolstat's more selective antibacterial activity.

[David Luci, President and CEO at Acurx Pharmaceuticals]

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 the broader spectrum of antibiotics like vancomycin and metronidazole, and a narrower spectrum of microbiome alteration compared to fidaxomicin. Also, in February 2025, last month, the Japanese Patent Office granted a new patent for our DNA polymerase IIIC inhibitors, which expires in December 2039, subject to expansion. This constitutes a significant building block for our ongoing development of ACX-375C, 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 placement, raising gross proceeds of $1.1 million.

[David Luci, President and CEO at Acurx Pharmaceuticals]

We continue to identify and pursue funding opportunities for our phase III clinical trial program. We have several initiatives underway to that end and hope to have something to report in future updates. Now we've got even more momentum going into 2025 and beyond. As we've continually reported, IBZ clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by 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. From a regulatory perspective, FDA has granted IBZ, QIDP, and Fast Track designations for the treatment of C. difficile infection.

[David Luci, President and CEO at Acurx Pharmaceuticals]

We also believe that ibezapolstat, if approved, could make a favorable economic impact by reducing the overall annual cost burden in the U.S. 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 file for. With our continuing momentum and passion to achieve success for our stakeholders, we do believe the best is yet to come. 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?

[Robert Shawah, CFO at Acurx Pharmaceuticals]

Thanks, Dave. Our financial results for the fourth quarter and year-end of 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-end of 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.

[Robert Shawah, CFO at Acurx Pharmaceuticals]

For the year-end of December 31, 2024, research and development expenses were $5.4 million, compared to $6 million for the year-end of 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-end of December 31, 2024, general and administrative expenses were $8.7 million, compared to $8.5 million for the year-end of December 31, 2023, an increase of $0.2 million.

[Robert Shawah, CFO at Acurx Pharmaceuticals]

The increase was 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, and a net loss of $14.1 million, or $0.87 per share, for the full year-end of December 31, 2024, compared to a net loss of $14.6 million, or $1.15 per share, for the year-end of 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.

[David Luci, President and CEO 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. Melissa?

[Operator]

Thank you. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd 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. Our first question comes from the line of Ed Arce with H.C. Wainwright. Please proceed with your question.

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

Hello, good morning, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you so much for taking our questions.

[David Luci, President and CEO at Acurx Pharmaceuticals]

Thank you, Thomas. Good morning.

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

Good morning. 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 III?

[David Luci, President and CEO at Acurx Pharmaceuticals]

It's identical, Thomas. 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 non-clinical, clinical, and manufacturing aspects with the FDA. Only with that in hand, we went with a final package to the Europeans, and it's identical protocol. There's complete agreement in all regards from both agencies.

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

Okay. In that vein, how do you envision the phase III program will enroll patients geographically? Will it be like a specific split between the U.S. and the EU, or how do you envision to proceed?

[David Luci, President and CEO at Acurx Pharmaceuticals]

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 the U.S., Canada, and South America.

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

Okay. That's good.

[David Luci, President and CEO at Acurx Pharmaceuticals]

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 U.S. compared to 50% of the sites in Europe.

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

I see. I got it. Moving on to additional data that you have been presenting, either at conferences or publications. After this microbiome study data that was published last month, when should we expect more data with ibezapolstat this year?

[David Luci, President and CEO at Acurx Pharmaceuticals]

That's a very poignant question. Thanks for asking. There's 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 30 days.

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

Okay.

[David Luci, President and CEO at Acurx Pharmaceuticals]

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]

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

[David Luci, President and CEO at Acurx Pharmaceuticals]

We have not taken any options off the table. Obviously, we are continuing our multi-step approach to funding the company and, most importantly, the phase III 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. I think those aspects of our activities are 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 are getting from some of the government and quasi-government agencies. I think that is 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.

[David Luci, President and CEO at Acurx Pharmaceuticals]

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.

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

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 III, or are there other options as well?

[David Luci, President and CEO 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. In a broad sense, yes, that's still the plan.

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

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

[David Luci, President and CEO at Acurx Pharmaceuticals]

Thank you so much, Thomas.

[Operator]

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

[David Luci, President and CEO at Acurx Pharmaceuticals]

Good morning, James.

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

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

[David Luci, President and CEO at Acurx Pharmaceuticals]

Of course.

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

Oh. I was just wondering if you could characterize the partnership environment, and there's a lot of turmoil in the market. Has that impacted your ability to secure partnerships? Is this something you think will happen in the 2025 timeframe, or is this a 2026 event? If you have any—and I know that perhaps that leads into the next question. When do you think you'll start the phase IIIs? I'm guessing that depends quite a bit upon either a partnership or a funding event, right?

[David Luci, President and CEO at Acurx Pharmaceuticals]

Yes. I agree, and I agree. The tumultuous nature of the things happening in the world today certainly presents an even more keen challenge than we were facing coming into 2025. 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. 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's 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. Hopefully, things settle down over the next couple of months, and we can get down to some appropriations.

[David Luci, President and CEO at Acurx Pharmaceuticals]

There are still appropriations from prior approvals, government-approved programs that we're chasing down and, in one case, have applied for. We're continuing the process. I think something will happen in 2025 that will allow us to start the phase III 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. That's the final step, and that'll take place after the money comes in. That may present a few months' time lag between having the sufficient funding and starting the enrollment. Does that answer your question?

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

It does indeed. There is 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 top-line data, or an interim look? What do you think that could occur should the trial start tomorrow?

[David Luci, President and CEO at Acurx Pharmaceuticals]

Yeah. 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 would not really provide us anything other than an advisory committee would tell us keep enrolling or futility. We would not be able to see any of the numbers, it being a double-blind study. We did not do the interim look, but I think it would be two years from first patient enrolls to top-line data.

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

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

[David Luci, President and CEO at Acurx Pharmaceuticals]

Excellent. I hope you enjoyed your holiday yesterday.

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

Could you have the call? Not on the day of today's podcast.

[Operator]

Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star 1 on your telephone keypad. Our next question comes from the line of Claire Aitchison with Independent Investment Research. Please proceed with your question.

[Claire Aitchison, Head of Equities and Funds Research at Independent Investment Research]

Good morning, gentlemen.

[David Luci, President and CEO at Acurx Pharmaceuticals]

Good afternoon, Claire.

[Claire Aitchison, Head of Equities and Funds Research at Independent Investment Research]

Just a couple of things from me. I just noticed that you'd 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. Also, if you could just comment on the risk with the Nasdaq listing given where the share price is currently trading.

[David Luci, President and CEO at Acurx Pharmaceuticals]

Sure. 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 to do that. There is no prohibition on us reactivating the ATM. It is currently not part of our ongoing plan, which will unfold over the next several months. With the de-listing, I can tell you, Claire, that there is no sense internally that we will let the Nasdaq listing go. We are working on some things which we think will help with the listing in that regard. Leave it with us for now, but the last thing I would expect to see is for us to be traded out of the Bulletin Board.

[Claire Aitchison, Head of Equities and Funds Research at Independent Investment Research]

Okay. So you're confident you'll be able to manage that?

[David Luci, President and CEO at Acurx Pharmaceuticals]

Oh, yes. Absolutely.

[Claire Aitchison, Head of Equities and Funds Research at Independent Investment Research]

Okay. Great. Thank you.

[David Luci, President and CEO 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.

[David Luci, President and CEO at Acurx Pharmaceuticals]

Thank you, Melissa.

[Robert Shawah, CFO at Acurx Pharmaceuticals]

Thank you.

Participants

Executives

• Robert Shawah, CFO
• David Luci, President and CEO

Analysts

• James Molloy, Managing Director, Senior Biotechnology, and Specialty Pharmaceuticals Equity Analyst at Alliance Global Partners
• Thomas Yip, Research Associate at H.C. Wainwright
• Claire Aitchison, Head of Equities and Funds Research at Independent Investment Research