Transcript: Acurx Pharmaceuticals Q2 2026 Earnings Conference Call

Acurx Pharmaceuticals (NASDAQ: ACXP ) reported second-quarter financial results on Friday. The transcript from the company's second-quarter earnings call has been provided below. APIs provide real-time access to earnings call transcripts and financial data. Visit to learn more.

6 million at the end of 2025. The company is advancing its Ibezapolstat clinical development with FDA guidance for a Phase 3 trial (IBEZ ASPIRE) and plans for a Pathfinder study in recurrent CDI, aiming to start enrollment in Q4 2026. Acurx secured FDA conditional acceptance for the brand name CFezi for Ibezapolstat and continued its partnership with Leiden University to develop DNA Pol3C inhibitors. 1 million direct offering in April 2026, ensuring funding for the Pathfinder trial and operations for at least one year.

Management highlighted the significance of FDA discussions for potential approval pathways, including the LPAD pathway for recurrent C. diff, and emphasized ongoing funding efforts for the ASPIRE trial. Full Transcript OPERATOR Greetings, and welcome to Acurx Pharmaceuticals to discuss second quarter 2026 financial results on August 14, 2026, and provide a business update. At this time, all participants will be in listen-only mode.

The question-and-answer session will follow the formal presentation. If anyone should require operator assistance today, please press star-zero on your telephone keypad. Please note this conference is being recorded. I'll now turn the conference over to Robert Shawah, Chief Financial Officer.

Thank you. You may begin. Robert Shawah, Chief Financial Officer Thank you, Rob. Good morning, and welcome to our call.

com. Joining me today is David Luci, President and CEO of Acurx. We will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials for the second quarter ended June 30, 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, Thursday, August 13, 2026.

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, August 14th. I'll now turn the call over to Dave Luci. Dave.

David Luci, President and Chief Executive Officer Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the second quarter and also to hear some recent updates on our continuing progress. Then we'd be pleased to take any questions. Our Executive Chairman, Bob DeLuccia, and our Medical Director, Dr.

Michael Silverman, have joined us today and will be available to answer questions about our recent FDA meeting and our clinical development plan for Ibezapolstat, both in recurrent C. diff infection and in acute CDI. First, I'd like to briefly summarize just a few of our key activities for the second quarter of 2026 or, in some cases, shortly thereafter.

Last month, in July 2026, the company's research and development team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single Phase 3 study in acute CDI and its acceptability as a pivotal trial for filing a new drug application, the outcome of which we provided more detail in our August 3rd press release.

Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the Ibezapolstat clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial called IBEZ ASPIRE and any other clinical trials conducted prior to the pre-NDA meeting, which will include the Pathfinder study, 20 patients open-label in recurrent CDI, particularly if the clinical efficacy results are robust. As you may recall from our previous announcements, we've begun startup activities to conduct the 20-patient groundbreaking Pathfinder study in multiple recurrent CDI, with enrollment anticipated to start in the fourth quarter.

This trial was acknowledged by FDA as being significant and, along with robust results from our ASPIRE trial, will form the basis of a potential approval for the treatment of CDI and for the prevention of recurrent CDI. In August 2026, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary name, or brand name, for Ibezapolstat, which I'll share with you now is CFezi. These initial milestones will form the basis for the commercial identity of Ibezapolstat as the company prepares to advance it toward its international Phase 3 registration program and ultimate commercialization.

Also in July, we signed and announced last week a continuation of our scientific partnership with Leiden University Medical Center to advance development of our DNA Pol3C inhibitors. This new partnership builds on the previously reported successful results from the innovative research grant received from the Dutch government in November 2025. This new partnership will enable further mechanistic research into DNA Pol3C inhibition to accelerate the development of novel new antibiotics that are systemically active against a wide range of Gram-positive pathogens resistant to currently available antibiotics.

This new research also aims to generate the first-ever 3D structure of PolC from methicillin-resistant Staphylococcus aureus in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen as designated by the CDC and the FDA. In the same month, in July, a presentation of scientific data by Dr.

Kevin Gary and his team from his laboratory at the University of Houston College of Pharmacy demonstrated that, following treatment in his state-of-the-art laboratory model with Ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, Ibezapolstat and fidaxomicin were superior in biofilm experimental models, with Ibezapolstat significantly more effective at killing C. diff than vancomycin and fidaxomicin.

Acurx remains prepared to commence its Phase 3 clinical trial program with the ASPIRE trial for the treatment of both CDI and reduction of recurrence, pending appropriate funding from public or private sources or partnerships. Our recent progress and efforts to secure this funding are ongoing. I'd also point out that our Pathfinder trial is fully funded and, if successful, will elevate the product profile of Ibezapolstat as well as provide significant supportive data for FDA's evaluation. 03 per share, priced at the market under Nasdaq rules.

65 million shares of common stock. 78 per share and are immediately exercisable upon issuance and will expire 24 months following the effective date of the registration statement registering resale of the shares of common stock underlying the short-term warrants. This additional funding, when coupled with the remaining availability under our equity line of credit, ensures that the company has the financial resource to conduct the Pathfinder clinical trial in recurrent CDI and fund operations for at least one year.

Also in April, a scientific poster showing that our new DNA Pol3C systemically absorbed antibiotics in preclinical development to treat other Gram-positive infections achieve potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a higher gut microbial diversity similar to baseline and distinct from linezolid. These data were presented at the 35th Congress held in Munich, Germany. Dr. Khurshida Begum, research scientist in the laboratory of Dr.

" The authors concluded that DNA Pol3C antibiotic compounds represent a targeted strategy to treat resistant Gram-positive infections while preserving microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis. Commenting on the significance of this data, Dr. Gary from the University of Houston stated, "Discovering highly selective antibacterial agents that specifically target systemic bacterial pathogens while avoiding the eradication of trillions of health-promoting bacteria in our gut microbiome is the holy grail of antibiotic development.

Initial work at the University of Houston with Acurx’ novel Pol3C inhibitors has demonstrated favorable gut microbiome-sparing effects. " So this work, coupled with our recently announced scientific partnership with Leiden University Medical Center, will pave the way for further rational design of novel DNA Pol3C inhibitors to expand our opportunities for lead optimization in our portfolio of groundbreaking anti-infective therapeutics. S.

patents and an additional 10 patents internationally, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key aspects of our company's Ibezapolstat and the ACX375C program targeting DNA Pol3C. Additional country-level patent applications remain under review. Also, and significantly, in the first quarter a new patent was issued related to Ibezapolstat and its use to treat CDI while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. Additional country-level patent applications remain under review.

We continue to identify and pursue funding opportunities for our Phase 3 ASPIRE trial for the treatment of both acute CDI and a reduction of recurrence. We have several initiatives underway to this end and will report our progress in future updates. As we've continually reported, Ibezapolstat's clinical and non-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.

Furthermore, Ibezapolstat has FDA QIDP and Fast Track designations for treatment of CDI as well as SME, or small and medium enterprise, status in the EU. All Acurx compounds in preclinical development are FDA and Fast Track eligible, not received yet, and target positive infectious diseases classified as serious threat priorities by CDC and FDA. We remain confident that while development of Ibezapolstat's competitive profile continues to evolve and strengthen, we'll continue to successfully navigate through these challenging times in our industry sector.

And now, back over to Rob Shawah, our CFO, to guide you through the highlights of our financial results for the second quarter of 2026. Rob. Robert Shawah, Chief Financial Officer Thanks, Dave. Our financial results for the second quarter ended June 30, 2026 were included in our press release issued earlier this morning.

6 million as of December 31, 2025. 5 million of gross proceeds through a registered direct offering, as well as under the equity line of credit. 6 million. 3 million, as a result of costs associated with the new recurrent CDI trial program.

1 million for the six months ended June 30, 2025. 2 million increase in manufacturing costs, as a result of costs associated with the new recurrent CDI trial program. 5 million. 1 million decrease in share-based compensation expense.

6 million. 7 million. 0 million decrease in share-based compensation expenses. 53 per diluted share, for the three months ended June 30, 2026.

89 per diluted share, for the three months ended June 30, 2025. 13 per diluted share. 01 per diluted share, for the six months ended June 30, 2025, all for the reasons previously mentioned. The company had 4,683,253 shares outstanding as of June 30, 2026.

With that, I'll turn the call back over to Dave. David Luci, President and Chief Executive Officer Thanks, Rob, and to all of you for joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to the call our Medical Director, Dr. Michael Silverman, and our Executive Chairman, Bob DeLuccia, to assist with Q&A regarding our recent FDA meeting and our Ibezapolstat clinical development program.

And now back to the operator to open the call for questions. OPERATOR Thank you. We'll now be conducting our question-and-answer session. If you'd like to ask a question at this time, you may press star-one from your telephone keypad, and 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 keys. Thank you. And our first question is from the line of Radhika Chirupali with S&P.

Please proceed with your questions. Radhika, your line is open for a question. It seems like we've lost connection with Radhika. We'll move on to our next question, from Matthew Keller of HC Wainwright.

Please proceed with your questions. Matthew Keller, Analyst at HC Wainwright Hey, good morning. Thanks for taking the questions. So, my first one related to manufacturing.

I was wondering, do you have enough API for the planned upcoming trials? And I guess where do you stand, potentially, on manufacturing Ibezapolstat? David Luci, President and Chief Executive Officer Thank you, Matt. Bob, would you like to— Robert DeLuccia, Executive Chairman Yeah.

If I understood the question, where do we stand on— We have plenty of API, and also the formulated product is all ready to go to support the Pathfinder trial, and we're poised to have enough API manufactured with appropriate dating to start the Ibezapolstat ASPIRE trial as well. Matthew Keller, Analyst at HC Wainwright Perfect. And then a second question, if I may. David Luci, President and Chief Executive Officer Oh, go ahead.

Sorry. Yep. Oh, I want to make sure that answered your question. Matthew Keller, Analyst at HC Wainwright Oh, yeah.

And the second question, I guess, if I may again, you guided that the ASPIRE trial will be an international trial. I was wondering what geographies you guys are considering, and if you've begun start-up activities in those regions for that trial. David Luci, President and Chief Executive Officer Yep, I can answer that as well. Mike, are you on the line?

You can join in, just to give an idea of the scope of the trial internationally. Michael Silverman, Medical Director Well, the plans are international. I don't have my finger on the pulse of every country that we've considered, but certainly Western and Eastern Europe. Bob, please expand if you can.

Robert DeLuccia, Executive Chairman Yeah, we can follow up with the details of the countries, but we haven't begun screening for that yet.