Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals first quarter 2026 earnings 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 during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the call over to your host, Mr. Rob Shawa, Chief Financial Officer. Please go ahead, sir.

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 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 financial results from the first quarter ended March 31, and then turn the call 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 10Q, which we filed yesterday, Monday, May 11, 2026. You are questioned not to place undue reliance on these forward-looking statements and after access claims 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 12, 2026. I'll now turn the call over to Dave. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the first quarter of 26 and also to hear some recent updates. Then we'd be pleased to take any questions. For the Q&A, our Executive Chairman, Bob DeLucia, and our Medical Director, Michael Silverman, have joined us today and will be available for those questions about our R-CDI program or other matters. First, I'd like to briefly summarize just a few of our key activities for the first quarter of 2026, or in some cases, shortly thereafter. On March 9th, 26, we issued a press release announcing that we're starting up a groundbreaking ibuprofen trial program in patients with recurrent CDI or R-CDI. that has the potential to shift the paradigm of treatment and prevention of recurrent C. diff from two agents to just one, our Ibezopulstat. When coupled with Ibezopulstat Phase II results, which showed a 96% cure rate with no recurrent C. diff in 25 of 25 patients who were cured, scaring the microbiome, this new trial has the potential to position Ibezopulstat to be a new standard of care as the first agent to treat both acute CDI and prevent R-CDI. In the acute CDI phase 2 trial, all 25 patients, 100%, treated with I-VEZ, who experienced a clinical cure of CDI, were free of recurrence one month after treatment. And very importantly, five of five of these patients who were observed for three months after treatment remained free of recurrence. The new clinical trial in R-CDI builds on a physical strength, mainly that no patients who are cured of their infection experience a recurrence. So, clinicians and patients are avoiding the recurrence trap associated with currently available therapies. This new trial begins with an open-label pilot study to gain experience in patients with multiple recurrent CDI who had at least three episodes of CDI within the past 12 months. This will inform elements of a planned active control phase 3 registration trial in the RCDI indication to be implemented following favorable results from the open-label 20-patient trial. Upon subsequent successful completion of the phase 3 pivotal RCDI trial and per the operative FDA procedure, after it's passed the request, FDA approval for treatment and prevention of RCDI under the FDA's limited population pathway for antibacterial and antifungal drugs guidance for industry. ACRx clinical program in the broader acute CDI patient population is ready to advance to phase three international physical clinical trials. In this regard, we're very excited about the FDA's recent announcement published in the New England Journal of Medicine that a one trial requirement will be FDA's new default standard. that is for registration. If formalized, and we can talk about that in the Q&A, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and potentially favorable implications to our clinical development program, such as the opportunity to seek marketing approval for the acute CDI population with one pivotal clinical trial. On March 30th, 2026, we announced that the Korean Patent Office granted a new patent which covers DNA polymerase 3C inhibitors, including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen ACRES's intellectual property portfolio and represents the most recent addition to our standing series of granted patents in the U.S. and internationally. To date, we've secured 10 patents, including five U.S. patents, along with patents in Israel, Japan, India, Australia, and Korea, all of which protect key aspects of the company's product pipeline. Also, and significantly, a new patent was recently issued relating to Ibenzapulstat and its use to treat CEI while reducing recurrence of infection and improving the health of the gut microbiome. Additional country-level patent applications remain under review. In February 26, we announced that the USPTO granted a new patent for our DNA-PAL3C inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under US patent rules. On April 16, 2026, the company announced the closing of a registered direct offering About 825,085 shares of our common stock were pre-funded warrants in lieu thereof at a purchase price of $3.03 per share for a pre-funded warrant in lieu thereof. 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 1,650,170 shares of common stock. The short-term warrants have an exercise price of $2.78 per share and are immediately exercised upon issuance and will expire 24 months following the effective date of the registration statement registering the resale of the shares of common stock underlying the short-term warrants. And that registration statement, I'm happy to say, is now effective. This additional funding, when coupled with the remaining availability under our equity line of credit, ensures that the company has the financial resources to conduct the exploratory clinical trial in recurrent C. difficile infection. And just last month, a scientific poster showing our new DNA-PAL3C systemically absorbed compounds in preclinical development to treat other gram-positive infections achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining a high microbial diversity similar to baseline and distinct from . This poster was presented at the 35th Congress of Estimated Global, the European Society of Clinical Microbiology and Infectious Disease Annual Scientific Conference held in Munich, Germany from April 17 to April 21. Dr. Karshida Begum, research scientist, University of Houston College of Pharmacy, presented the poster entitled, preclinical microbiome evaluation of novel palsy inhibitor compounds. Using microbiome profiling metagenomics, the authors concluded that BNA-PAL3C compounds represent a targeted strategy to treat resistant gram-positive infections while preserving the microbiome structure, minimizing downstream complications associated with antibiotic-induced dysbiosis. We continue to identify and pursue funding opportunities for our phase three clinical trial program for ibuprofen and acute CDI. We have several initiatives underway to this end and we'll report results in future updates. As we continually reported, IBEZ 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. They also have a low incidence of recurrence. Additionally, Ibexapoltec has FDA QIDP and fast track designations for treatment of CDI, as well as in Europe, small and medium enterprise or SME status. Furthermore, all accurate compounds in preclinical development are eligible for a QIDP and fast-track designation. And they target rare positive infections classified as serious threat priorities by the CDC. We remain confident that while development by Vesipol staff's competitive profile continues to evolve and strengthen, we'll continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. And now back to our CFO, Rob Schaller, to guide you through the highlights of our financial results for the first quarter of 2026. Rob? Thanks, Dave.