Acurx Pharmaceuticals - Earnings Call - Q2 2025

Transcript

Speaker 0

Welcome to the Acurx Pharmaceuticals to discuss second quarter 2025 financial results conference call. 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, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Robert Shawah, Chief Financial Officer. Please go ahead.

Speaker 4

Thank you, Stacy. Good morning and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the second quarter of 2025, which is available on our website at acurxpharma.com. Joining me today is David Luci, President and CEO of Acurx Pharmaceuticals, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter ending June 30th and then turn the call back over to David 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. They're all 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 filing through the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed yesterday, Monday, August 11th, 2025. You are cautioned not to place undue reliance on these forward-looking statements, and Acurx Pharmaceuticals 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, August 12th, 2025. I'll now turn the call over to David. David?

Speaker 1

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter of 2025 and also hear some recent updates. We'll be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the second quarter, or in some cases, probably thereafter. In April, we announced that the Indian Patent Office granted a new patent for our DNA polymerase 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-375C, which targets the treatment of infections caused by MRSA, VRE, VRSP, and anthrax. In May, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding.

In June, the company entered into a warrant inducement agreement with an existing warrant holder for the exercise of warrants to purchase an aggregate of 222,272 shares of the company's common stock, having a current exercise price for the Series A warrants to purchase 51,538 shares of the company's common stock at $65 per share, for Series B warrants to purchase 27,400 shares of our common stock at $65 per share, for Series C warrants to purchase 66,667 shares of our common stock at $65.20 per share, and Series D warrants to purchase 66,667 shares of our common stock at an exercise price of $65.20 per share. The original agreement was dated July 2022 and May 2023 at this exercise price of $12 per share.

To ensure anything for the company's agreements to issue, new Series C1 warrants to purchase up to an aggregate of 311,180 shares of common stock with a five-year term, and new Series C warrants to purchase up to an aggregate of 133,353 shares of our common stock with a five-year term from shareholder approval, each at an exercise price of $8.50 per share. The gross proceeds to the company from the exercise of the existing warrants were approximately $2.7 million, with net proceeds of $2.5 million after deducting fees and expenses payable by the company. The warrant inducement transaction closed on June 20th. The company will continue its multi-step approach to raising capital through customary financing, warrant inducements, and public-private partnership opportunities going forward. In June, we announced the publication of our ibezapolstat clinical trial data for Clostridioides difficile infection in The Lancet Microbe, the world-leading microbiology research journal.

This publication is available on our website at acurxpharma.com. The Lancet Microbe summary highlighted our ibezapolstat Phase 2 results as follows, and I quote, "The results included high rates of clinical cure in our ibezapolstat subjects with no recurrence. Furthermore, our ibezapolstat was found to be safe, well-tolerated, and associated with the preservation of key health-promoting bacteria responsible for bioactive homeostasis, a key component in preventing recurrent CDI." The Lancet publication also highlighted our ibezapolstat's potential as a novel antibiotic treatment for CDI with high rates of clinical cure and sustained clinical cure, while preserving and restoring the healthy gut microbiota. The senior author, Professor Kevin Garey, PhD, University of Houston and a co-author of the IDSA Infectious Diseases Society of America Treatment Guidelines for C. difficile infection, noted that current U.S. and European treatment guidelines for CDI recommend only two antibiotics for treatment: oral vancomycin or fidaxomicin.

Vancomycin is most commonly used but has a low clinical cure rate of 70% to 92% and a sustained clinical cure rate of 42% to 71%. Fidaxomicin has fewer recurrences, but low rates of clinical cure at about 84% and sustained clinical cure at 67%. Professor Garey further noted that both marketed antibiotics for CDI are associated with emerging antimicrobial resistance, stating and I quote, "The clinical need for a new antibiotic, like ibezapolstat, to treat CDI is underscored by a recently published study in Clinical Infectious Diseases 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 prevent other patients. The medical community should be aware of this alarming finding." End quote. Again, that's by Dr. Garey.

Also in June, we announced results from our collaboration with Leiden University Medical Center on its study of the mechanism of action of our DNA polymerase IIIC platform of inhibitors, with data presented at the Federation of American Societies for Experimental Biology Scientific Conference in the Netherlands on May 21st. A scientific presentation was provided by PhD from Leiden University Medical Center entitled, "A Unique Inhibitor Confirmation Selectively Targets the DNA Polymerase 3C of Gram-positive Priority Pathogens." This scientific conference is the premier venue for the newest research in technological trends in molecular machines in the human body that ensure DNA replication and expression of genes to create proteins that make up the cell. In August, we implemented a 1-for-20 reverse stock split in an effort to comply with the NASDAQ listing maintenance requirements.

We continue to identify and pursue funding opportunities for our Phase 3 clinical trial program for our ibezapolstat and consider alternative financial pathways to achieve success. We have several initiatives underway to defend and will report in future updates as appropriate. As we continually record, our ibezapolstat clinical results continue to demonstrate its leadership in the field and a serious and potentially life-threatening infectious disease called Clostridioides difficile infection that the U.S. CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Our ibezapolstat has FDA QIDP and Fast Track designations for the treatment of CDI. We also believe that our ibezapolstat, if approved, could make a favorable economic impact by reducing the overall annual U.S. cost burden for C.

difficile infection of approximately $5 billion a year, of which $2.8 billion is due to recurrent infection, what we call the secondary market. With our continuing investment and passion to achieve success for our stakeholders, we remain confident that while development of our ibezapolstat's competitive profile continues to strengthen, the best is yet to come as we navigate through these very challenging times in the macroeconomic environment and in our industry sector. Now back to our CFO, Robert Shawah, to guide me through the highlights of our financial results for the second quarter of 2025. Rob?

Speaker 4

Thanks, Dave. Our financial results for the second quarter ending June 30, 2025, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $6.1 million, compared to $3.7 million as of December 31, 2024. During the second quarter, the company raised a total of approximately $3.4 million of gross proceeds through purchases under the equity line of credit and a warrant inducement agreement. Research and development expenses for the three months ending June 30 were $0.5 million, compared to $1.8 million for the three months ending June 30, 2024, a decrease of $1.3 million. The decrease was due primarily to a decrease in manufacturing costs of $0.3 million and a decrease in consulting costs of $1 million as a result of the prior year trial-related expenses.

For the six months ending June 30, 2025, research and development expenses were $1.1 million versus $3.4 million for the six months ending June 30, 2024. The decrease of $2.3 million was primarily due to a reduction of $0.6 million in manufacturing costs and a $1.7 million decrease in consulting costs due to higher trial-related costs in the prior year. General and administrative expenses for the three months ending June 30, 2025, were $1.7 million compared to $2.3 million for the three months ending June 30, 2024, a decrease of $0.6 million. The decrease was primarily due to a $0.7 million decrease in share-based compensation and a $0.1 million increase in professional fees. For the six months ending June 30, 2025, general and administrative expenses were $3.3 million versus $5.1 million for the six months ending June 30, 2024, a decrease of $1.8 million.

The decrease was due primarily to a $0.6 million decrease in professional fees and a $1.2 million decrease in share-based compensation. The company reported a net loss of $2.2 million or $1.89 per diluted share for the three months ending June 30, 2025, compared to a net loss of $4.1 million or $5.21 per diluted share for the three months ending June 30, 2024. The company reported a net loss of $4.4 million or $4.01 per diluted share for the six months ending June 30, 2025, compared to a net loss of $8.5 million or $10.84 per diluted share for the six months ending June 30, 2024, all for the reasons previously mentioned. The company had a reverse split adjusted 1,470,352 shares outstanding as of June 30, 2025. With that, I'll turn the call back over to David.

Speaker 1

Thanks, Rob, and to all of you for joining us today. Now back to our operator, Stacy, to open the call to questions. Stacy?

Speaker 0

Thanks. To stay here, we will now be conducting a question and answer session. If you would 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 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to take off your handset before pressing the star two. First question, James Molloy with Alliance Global Partners in Sea Shore.

Speaker 2

Hey, guys. Good morning. Thank you for taking my questions. Just a quick call. Thank you. Looking at the OpEx coming down, you know, in line certainly with cash preservation, high priority. This is a trend we should expect to continue through the rest of 2025 and 2026. Maybe following up on that, I know it's a bit up in the air and a little out of your hands, but as an outsider looking in, when should we anticipate potentially either a partnership or, particularly, a particular partnership to be signed? Is that something that 2025 or you're looking at in 2025 or 2026? I mean, and you're getting trials up and running for ibezapolstat. Thank you.

Speaker 1

I'll start with your second question. I'll ask you to repeat the first. For your second question, it could be any time here in the second half in terms of a private partnership if we're able to announce something like that. I use the word partnership broadly to include government agencies, because that's their preference. They like to say that they're not providing grants. They're entering into partnerships and they expect their incubator companies to be good partners. That process is ongoing and will certainly look into 2026, given the dynamics that are going on in Washington. The federal government's year-end is September 30th.

As I understand it through the folks we work with in Washington, they're expecting a continuing resolution toward the end of the year, kind of the usual annual punt to calendar year-end as being likely the time when funding for the new fiscal year gets appropriated through the funding with the House Raise and Needs Committee. Those are all going very well, I would say. We're confident that we will have success in these regards. I think particularly that the government is going to take time. Could I ask you to ask the first question again, please?

Speaker 2

Yes, of course. I see that you guys are, you know, preserving cash, operating expenses coming down, nicely in line with your expectations of good capital. Is that something we should expect, a trend that should continue to expect in the next 2025 and into 2026?

Speaker 1

Absolutely. Yeah, we're trending tremendously. What I would say is, when you're seeing things like G&A expenses that we report on these earnings calls, that's a different number than cash flow. That includes cash and non-cash items. Our cash burn is down to close to $400,000 a month at this point, and we expect to continue that process. There are some clinical strategy things that we will be announcing in the near future that we're currently considering for a new, very small clinical trial that we can handle financially without a lot of heavy lifts on our end. We'll be able to come out with more information on that next quarter after we get in front of our board of directors.

Speaker 2

Excellent. As always, excellent work on keeping the accruals in line. Thank you, David.

Speaker 1

Thank you so much. Thank you, Jason.

Speaker 0

Once again, if you would like to ask a question, please press star one on your telephone keypad. Next question comes from Matthew Taylor with HC100. Please proceed.

Speaker 3

Yeah. Hey, good morning, everyone, and congrats on the quarter. Just two quick ones from us. Obviously, the publication of the two, the two big data was very nice. I was wondering if there were any additional feedback that you got from either the physician community or KOL community on that publication. The second question I have for you is kind of related to maybe the previous questions, but are there any other rate-limiting steps ahead of the upcoming Phase 3 studies that we should be thinking about?

Speaker 1

Thank you, Matthew, for the questions. For rate-limiting steps, the only one, and it's not even really a long rate limit, would be just, as we've talked about, the cell phenics of the ibezapolstat supply into the Phase 3 trials. We've been reluctant to do cell phenics because once you do, then your drug is dangerous. We want to postpone that to maximize the amount of time we have to use the ibezapolstat without it becoming obsolete. That may be a couple of months process. It's nothing significant. Everything else is literally ready. The European Medicines Agency and FDA, amazingly, agreed entirely on the identical chain protocol for the two trials. That's gone quite well.

Speaker 3

Okay. Great. Makes sense.

Speaker 1

Thank you.

Speaker 0

There are no further questions. This does conclude today's teleconference. Thank you for your participation. You may now be disconnected.