Acurx Pharmaceuticals - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 narrowed net loss to $2.15M ($0.11/share) driven by deliberate cost cuts in both R&D and G&A; cash increased to $4.64M following ~$3.6M gross proceeds raised during the quarter.
• Regulatory de-risking advanced: EMA scientific advice aligned with FDA on Phase 3 design and CMC, confirming the path to MAA filing upon successful Phase 3; Phase 3 start remains funding-dependent.
• Evidence base strengthened: two NIAID/NCI/NCATS-supported non-clinical studies highlighted IBZ’s microbiome-preserving profile versus vancomycin/metronidazole and differentiated from fidaxomicin; Phase 2 data accepted for publication in Lancet Microbe (in press at the time of the call).
• Funding runway bolstered post-quarter via a $12M equity line with Lincoln Park Capital; management reiterated aggressive cost control until Phase 3 funding is secured, with multiple non-dilutive avenues being pursued (PASTEUR, BARDA, ARCH, European sources).

What Went Well and What Went Wrong

What Went Well

• Cost discipline: R&D fell to $0.60M (from $1.56M y/y) on lower manufacturing and consulting; G&A fell to $1.55M (from $2.82M y/y) on lower professional fees and share-based comp; net loss shrank to $2.15M ($0.11/share) from $4.38M ($0.28/share).
• Regulatory clarity: EMA guidance aligned with FDA on Phase 3 program and confirmed an MAA pathway after successful Phase 3, positioning ACXP to commence an international Phase 3 upon funding.
• Differentiation data and visibility: Non-clinical studies showed narrower microbiome disruption versus vancomycin/metronidazole and differentiation from fidaxomicin; Phase 2 clinical results accepted (in press) for Lancet Microbe publication, supporting potential anti-recurrence advantages.

Management quotes:

• “With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.”
• “We’ve done some dramatic cost cutting… and I would expect both our G&A and our R&D cost to continue to go down… until we start the Phase III program.”
• “We continue to identify and pursue funding opportunities for our Phase III… we have several initiatives underway…”

What Went Wrong

• Phase 3 timing remains uncertain: Management will not guide to a start date given funding not yet secured; the company is “treading water” until financing closes.
• No product revenue; operating model remains expense-only with reliance on external capital (ATM previously, registered directs, and new equity line).
• Legislative/grant visibility remains limited near term: No specific update on PASTEUR Act timing; non-dilutive options under evaluation (BARDA, ARCH, Europe) but no awards yet.

Transcript

Operator (participant)

Thanks, and welcome to the Acurx Pharmaceuticals' first quarter 2025 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 would now like to turn the call over to your host, Rob Shawah, Chief Financial Officer of Acurx Pharmaceuticals. Thank you. You may begin.

Rob Shawah (CFO)

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 first quarter 2025, which is available on our website at acurxpharma.com. Joining me today is David 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 first quarter ended March 31, and then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we'll be making certain forward-looking statements which are based on current information, assumptions, estimates, and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed yesterday, Monday, May 12th, 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, May 13th, 2025. I'll now turn the call over to Dave Luci. Dave?

David Luci (President and CEO)

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the first quarter of 2025. To hear some recent updates, we would be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the first quarter 2025, or in some cases, shortly thereafter. In January, we announced that we closed a $2.5 million registered direct offering priced at the market under NASDAQ rules. Also, in January, we announced that we received positive regulatory guidance from the European Medicines Agency for the phase III clinical trial program, which is aligned with FDA on matters of manufacturing, non-clinical, and clinical aspects of phase III program.

The EMA guidance also confirmed identical step's regulatory pathway for a marketing authorization application to be filed by the company after successfully completing phase III clinical trials. With mutually consistent feedback from both EMA and FDA, Acurx is well-positioned to commence our international phase III registration program. In February and March, 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 ibezapolstat versus all other antibiotics used for first-line therapy to treat C. difficile infection or CDI. For that matter, given our clinical results to date, we anticipate that this anti-recurrence effect of ibezapolstat could mitigate the patient's need for expensive microbiome therapeutic agents to prevent recurrent C. diff. Specifically, in February, we announced positive results from the first study conducted by Dr.

Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Disease. It was an in silico study that predicted the microbiome restorative potential of ibezapolstat for treating C. diff. 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 ibezapolstat and its target, the 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 the National Institute of Allergy and Infectious Disease, the National Cancer Institute, National Center for Advancing Translational Science, and Acurx. This study is the first head-to-head comparison of gut microbiome changes associated with ibezapolstat 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 ibezapolstat treatment were less pronounced compared to those observed in vancomycin or metronidazole treated groups, complementing prior phase II clinical findings showing ibezapolstat's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of the ibezapolstat and fidaxomicin treatment 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 broad spectrum antibiotics like vancomycin and metronidazole, and a narrower spectrum microbiome alteration compared to fidaxomicin. Also, in February, the Japanese Patent Office granted a new patent for our DNA pol IIIC inhibitors, which expires in 2039, subject to extension.

This constitutes a significant building block for our ongoing development of ACX-375, our preclinical antibiotic program targeting the treatment of infections caused by methicillin-resistant staph, vancomycin-resistant enterococcus, and anthrax. In March, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million. Just last month, the Indian patent office granted a new patent for our DNA pol IIIC inhibitors, which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing preclinical antibiotic development program of ACX-375, which targets the treatment of MRSA, VRE, and anthrax infections. Just last week, on May 8th, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding.

Looking forward to the weeks ahead, I can share with you that our outstanding phase II clinical trial data has been accepted for publication in the premier medical journal, Lancet Microbe, and is now in press to be published shortly and summarizes ibezapolstat's phase II results as follows, and I quote, "Results included high rates of clinical cure in ibezapolstat treated subjects with no recurrence. Furthermore, ibezapolstat was found to be safe, well-tolerated, and associated with the preservation of key health-promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent CDI. The publication establishes ibezapolstat's potential as a novel antibiotic treatment for CDI with high rates of clinical cure and sustained clinical cure, while minimally disturbing the protective gut microbiota." The senior author, Professor Kevin Garey, University of Houston and a co-author of the IDSA treatment guidelines for CDI.

Noted that current U.S. and European treatment guidelines for CDI. recommend only two [MNRs]: oral vancomycin or fidaxomicin. Vancomycin is most commonly used, but it has a low clinical cure rate of 70%-92% and a sustained cure rate of just 42%-71%. Fidaxomicin has fewer recurrences but low rates of clinical cure, 84%, and sustained clinical cure, 67%. Dr. Garey further notes that both antibiotics are associated with emerging antimicrobial resistance, stating, "The clinical need for a new antibiotic like ibezapolstat to treat CDI is underscored by a recently published study in clinical infectious disease by Dr. Curtis Donskey of the Cleveland VA and conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients.

The medical community should be aware of this alarming finding." Also, upcoming regarding Acurx's overall DNA pol IIIC inhibitor platform is a scientific presentation to be given on May 21 by Dr. Mia Urem from Leiden University Medical Center in the Netherlands, entitled "A Unique Inhibitor Conformation Selectively Targets the DNA pol IIIC of Gram-Positive Priority Pathogens." This scientific conference is sponsored by the Federation of American Societies for Experimental Biology and is the premier venue for the newest research and technological trends in molecular machines inside the human body that ensure DNA replication and expression of genes to create proteins that make up a cell. We continue to identify and pursue funding opportunities for phase III clinical trial program. We have several initiatives underway to that end, and we hope to have something to report in future updates.

As we've continually reported, ibezapolstat clinical results continue to outperform in a series of 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, like ibezapolstat. Ibezapolstat has FDA QIDP and Fast Track designations for the treatment of CDI. We also believe that ibezapolstat, if approved, could make a favorable economic impact by reducing the overall annual U.S. cost burden for C. diff infection, which is $5 billion per year, of which $2.8 billion is due to recurrent infection. With our continuing momentum and passion to achieve success for our stakeholders, we remain confident that the best is yet to come as we plow through these very challenging times in the macroeconomic environment and in our industry sector.

Now back to our CFO, Rob Shawah, to guide us through the highlights of our financial results for the first quarter of 2025. Rob?

Rob Shawah (CFO)

Thanks, Dave. Our financial results for the first quarter ending March 31, 2025, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $4.6 million compared to $3.7 million as of December 31, 2024. The company raised a total of approximately $3.6 million of gross proceeds through two registered direct offerings during the quarter. Research and development expenses for the three months ended March 31 were $0.6 million compared to $1.6 million for the three months ended March 31, 2024, a decrease of $1 million. The decrease is primarily due to a decrease in manufacturing costs of $0.4 million and a decrease in consulting costs of $0.6 million as a result of the prior year trial-related expenses.

General and administrative expenses for the three months ended March 31, 2025, were $1.6 million compared to $2.8 million for the three months ended March 31, 2024, a decrease of $1.2 million. The decrease is primarily due to a $0.7 million decrease in professional fees resulting from lower consulting expenses and a $0.6 million decrease in share-based compensation costs. The company reported a net loss of $2.1 million or $0.11 per diluted share for the three months ended March 31, 2025, compared to a net loss of $4.4 million or $0.28 per diluted share for the three months ended March 31, 2024, all for the reasons previously mentioned. The company had 22,397,511 shares outstanding as of March 31, 2025. With that, I'll turn the call back over to Dave.

David Luci (President and CEO)

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 (participant)

Thank you. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two 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 key. Our first question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Joanne Lee (Research Analyst)

Hi, good morning. This is Joanne Lee on for Jason McCarthy. Thanks for taking our question. Just one from me regarding the recent publications highlighting ibezapolstat's selective activity and potential microbiome-preserving effects. I'm just curious if the company plans to explore this further and if these complementary findings are informing the phase III trial in any way. Are you considering incorporating microbiome-related endpoints to help reinforce ibezapolstat's differentiation in the CDI space? Thanks.

David Luci (President and CEO)

Thank you very much, Joanne. Yes, we are indeed exploring this actively. It's already the microbiome preservation and restoration is already a secondary endpoint in the phase III program design as it had been in phase IIb. We are exploring it nonetheless. We are seeing that this is an area of differentiation, which is one of the primary reasons we believe that we are seeing so distinctively less recurrent C. diff than is experienced by patients on other antibiotics. With the new administration in Washington and Marty Makary, I believe we are reading the tea leaves and exploring other possibilities in terms of pathway to approval. We will look at more on that on the next call, but that's currently a hot topic internally.

Joanne Lee (Research Analyst)

Great. That was helpful. Looking forward to seeing how things progress.

David Luci (President and CEO)

Thank you so much.

Operator (participant)

Thank you. Again, as a reminder, it's star one to join the question queue. Our next question comes from the line of James Molloy with Alliance Global Partners. Please proceed with your question.

James Molloy (Managing Director and Senior Equity Analyst)

Hey, good morning, guys. Thanks for taking my questions. Just quick, looking at sort of G&A and R&D and OpEx, I guess, for the quarter, these are levels we should expect going forward. I see that R&D has been coming out pretty dramatically. I know you've been waiting to get the phase III started. I'll ramp up, and I presume it'll ramp up once that gets going. Any thoughts on the trajectory of that through 2025 and any updates on sort of the expected start date of any potential phase III?

David Luci (President and CEO)

Thanks so much, Jim. I appreciate the questions. I can hop in here. We've done some dramatic cost cutting that started in the first quarter of 2025 and will continue. I would expect both our GNA and our R&D costs to continue to go down as quarters go by until we start the phase III program. I don't want to provide a hypothetical date for the start of phase III because we don't have the funding yet. Since we don't make the decision on the other side of where that funding is coming from, it's kind of hard to project. We do have a lot of irons in the fire. We did close down the equity line of $12 million with Lincoln Park Capital last week.

We feel that we are in a decent position relative to other biotech companies to kind of tread water until one of these funding opportunities comes through.

James Molloy (Managing Director and Senior Equity Analyst)

[audio distortion] I guess you've been excellent stewards of shareholder capital, notably the accruals are always in good shape, Robert. As you look at the, any updates on the PASTEUR Act and what might be going on there?

David Luci (President and CEO)

We don't have anything specific on the PASTEUR Act, although I'm in touch with our lobby group probably a half dozen times a day. Things in Washington are frenetically busy, notably of recent vintage to drug pricing reductions, which in a strange way, I think, help our little company as compared to big pharma. Nothing specific on the PASTEUR Act, or I think we talked before about [PASTEUR Lille], but it's still out there. There's also traditional BARDA grants that may become available. For the second program, we recently put in an application to ARPA-H. There's a European FDA-type group that has taken some interest. We've got a lot of lines in the water, so to speak, for anyone who's a fisherman, like in the Cape Cod area or like yourself. We've got lines in the water, and we're just waiting to get a buddy.

James Molloy (Managing Director and Senior Equity Analyst)

That's understood. Last question, Marty Makary had some comments about sort of the ultra-rare path for approvals based on plausible mechanisms rather than actual clinical trials. That wouldn't apply to you guys, though, right?

David Luci (President and CEO)

You know, it's so funny. I mean, Joanne had a good question before. It's a great question. It's right on point with something that's being discussed internally right now based on Marty Makary's comments. It may apply to us. It would be a first for an antibiotic to follow that pathway, but our scientific team is taking a look.

James Molloy (Managing Director and Senior Equity Analyst)

It doesn't hurt to look. Absolutely. All right. Thank you guys very much for taking the questions.

David Luci (President and CEO)

Thanks so much, Jim.

James Molloy (Managing Director and Senior Equity Analyst)

Thank you.

Operator (participant)

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