Acurx Pharmaceuticals, Inc.

Greetings. Welcome to Accurix Pharmaceuticals to discuss second quarter 2026 financial results on August 14th, 2026. Conference call and provide business update. 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 Rob Shawah, Chief Financial Officer. Thank you. You may begin.

Thank you, Rob. 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 2026, which is available on our website at accorexpharma.com. Joining me today is Dave Lucci, President and CEO of Accorex, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from the second quarter ended June 30th and then turn the call back over to Dave for his closing remarks. As a reminder, during today's calls, 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 ACRx 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 day of this live broadcast, today, August 14th. I'll now turn the call over to Dave Luci. Dave?

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 Ibezopulstat, 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 three 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 IBEZ and Polistat Clinical Development Program at a pre-MDA meeting after completion of a single phase three trial called IBEZ-Aspire and any other clinical trials conducted prior to the pre-MDA meeting, which will include the Pathfinder study, 20 patients, open label, and 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 ground-breaking 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 both CDI and for the treatment of CDI, and 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 Cifbezi. These initial milestones will form the basis for the commercial identity of Ibezapolstat as the company prepares to advance it toward its International Phase III 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 systematically 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 Pol3C from methazone-resistant Staph aureus, in complex with by Acurex 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 Geary 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 Ipeza-Polstat, The beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, IBEZ and FIDAX were superior in biofilm experimental models with IBEZ significantly more effective at killing C. diff than vancomycin and FIDAX. Acurex remains prepared to commence its Phase III 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 IBEZ, as well as provide significant supportive data for FDA's evaluation. In April, the company announced the closing of a registered direct offering of up to $7.1 million, issuing 825,085 shares of our common stock or pre-funded warrants at a purchase price of $3.03 per share, priced at the market under NASDAQ rules. In addition, in a concurrent private placement, the company issued unregistered short-term warrants to purchase up to 1.65 million shares of common stock. The short-term warrants have an exercise price of $2.78 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 C. diff and fund operations for at least one year. Also in April, a scientific poster showing that our new DNA, PAL3C, systemically absorbed antibiotics in preclinical development to treat other gram-positive infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a higher gut microbial diversity similar to baseline and distinct from lenizolate. These data were presented at the 35th Congress of Estimates held in Munich, Germany. Dr. Krishida Bigham, research scientist in the laboratory of Dr. Kevin Geary at University of Houston, presented the poster entitled Preclinical Microbiome Evaluation of Novel PAL-C Inhibitor Compounds. Using microbiome profiling metagenomics, the authors concluded that DNA PAL-3C 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 quote-unquote holy grail of antibiotic development. Initial work at the University of Houston with Actorix novel PAL-3C inhibitors has demonstrated favorable gut microbiome sparing effects. The novel findings presented at ESCNID demonstrate these positive microbiome results to be a class effect of DNA PAL-3C inhibitors, potentially positioning them as unique additions to the anti-gram-positive therapeutic armamentarium. 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-infected therapeutics. With regard to our patent estate, to date Acurex has secured six U.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 Ibezopolstat and the ACX375C program, targeting DNA-PAL3C. Additional country-level patent applications remain under review. Also, and significantly, in the first quarter, a new patent was issued relating to Ibez 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 III 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, IBA's clinical and non-clinical results continue to outperform and a serious and potentially life-threatening infectious disease caused by a seed to the sealed 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, IVEZ 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 Acurex compounds in preclinical development are FDA and Fast-Track eligible, not received yet, and target positive infectious disease classified as serious threat priorities by CDC and FDA. We remain confident that while development of IBEZ competitive profile continues to evolve and strengthen, will continue to successfully navigate through these challenging times in our industry sector. And now back over to Rob Shaw, our CFO, to guide you through the highlights of our financial results for the second quarter of 2026.