Acurx Pharmaceuticals, Inc. Q2 2025 earnings call

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?

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 II 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%-92% and a sustained clinical cure rate of 42%-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 III 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?

Thanks, Dave. Our financial results for the second quarter ending June 30th, 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 30th were $0.5 million, compared to $1.8 million for the three months ending June 30th, 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 30th, 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.

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