Acurx opened 2026 with an improved balance sheet and a potentially pivotal regulatory development. The company ended the first quarter with $9.3 million in cash (up from $7.6 million), and in April 2026 closed a registered direct offering at $3.03 per share plus a concurrent short-term-warrant private placement that, together with its equity line of credit, funds the exploratory recurrent-CDI trial. Operating discipline held, with Q1 R&D of $0.3 million and G&A of $1.4 million narrowing the net loss to $1.7 million, or $0.62 per share. The headline was regulatory: the FDA issued final guidance formalizing that a single adequate and well-controlled trial supported by confirmatory evidence may suffice for C. difficile, a standard management believes ibezapolstat's mechanistic, in vitro, animal-model and microbiome data can help meet, and Acurx scheduled a summer FDA meeting to apply it to its program. The company also grew its patent portfolio to 10 granted patents with a new Korean patent and presented ESCMID data supporting its preclinical ACX-375C Gram-positive program, while the recurrent-CDI pilot moved into site startup with a first patient targeted around August 2026.
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 acurxpharma.com. Joining me today is David Luci, President and Chief Executive Officer of Acurx, 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 ending March 31, and then turn the call 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 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 quarter report on Form 10-Q, which we filed yesterday, Monday, May 11, 2026. You are cautioned not to place undue reliance on these forward-looking statements. 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, 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 2026 and also to hear some recent updates. We'd be pleased to take any questions. For the Q&A, our Executive Chairman, Bob DeLuccia, and our Medical Director, Michael Silverman, have joined us today and will be available for those questions about our rCDI 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, 2026, we issued a press release announcing that we're starting up a groundbreaking ibezapolstat clinical trial program in patients with recurrent CDI or rCDI that has the potential to shift the paradigm of treatment and prevention of recurrent C.
From two agents to just one, our ibezapolstat. When coupled with ibezapolstat phase II results, which showed a 96% cure rate with no recurrent C. difficile in 25 of 25 patients who were cured, sparing the microbiome, this new trial has the potential to position ibezapolstat to be a new standard of care as the first agent to treat both acute CDI and prevent rCDI. In the acute CDI phase II trial, all 25 patients, 100% treated with ibe who experienced a clinical cure of CDI were free of recurrence one month after treatment. Very importantly, five of these patients who were observed for three months after treatment remained free of recurrence. The new clinical trial in rCDI builds on ibezapolstat's strength, namely that no patients who were cured of their infection experienced a recurrence.
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 with ibezapolstat in patients with multiply recurrent CDI who've had at least three episodes of CDI within the past 12 months. This will inform elements of a planned active control phase III 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 III pivotal rCDI trial and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's limited population pathway for antibacterial and antifungal drugs guidance for industry. Acurx clinical program in the broader acute CDI patient population is ready to advance to phase III international pivotal 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 the 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 30, 2026, we announced that the Korean Intellectual Property Office granted a new patent which covers DNA polymerase IIIC inhibitors, including compositions of matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to our expanding 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. Significantly, a new patent was recently issued relating to ibezapolstat and its use to treat CDI while reducing recurrence of infection and improving the health of the gut microbiome. Additional country-level patent applications remain under review. In February 2026, we announced that the USPTO granted a new patent for our DNA pol IIIC inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under U.S. patent rules.
On April 16th, 2026, the company announced the closing of a registered direct offering of 825,085 shares of our common stock or pre-funded warrants in lieu thereof at a purchase price of $3.03 per share or 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.
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 resource to conduct the exploratory clinical trial in recurrent C. difficile infection. Just last month, a scientific poster showing our new DNA pol IIIC 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 gut microbial diversity similar to baseline and distinct from linezolid. This poster was presented at the 35th Congress of ESCMID Global, the European Society of Clinical Microbiology and Infectious Diseases Annual Scientific Conference, held in Munich, Germany from April 17 to April 21.
Dr. Khurshida Begum, research scientist, University of Houston College of Pharmacy, presented the poster entitled Preclinical Microbiome Evaluation of Novel DNA pol IIIC Inhibitor Compounds. Using microbiome profiling metagenomics, the authors concluded that DNA pol IIIC 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 III clinical trial program for ibezapolstat and acute CDI. We have several initiatives underway to this end and will report results in future updates. As we've continually reported, ibez clinical and non-clinical results continue to outperform in a series of 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 and also have a low incidence of recurrence.
Ibezapolstat has FDA QIDP and Fast Track designations for treatment of CDI, as well as in Europe, small and medium enterprise or SME status. All Acurx compounds in preclinical development are eligible for QIDP and Fast Track designation, and they target Gram-positive infections classified as serious threat priorities by the CDC. We remain confident that while development of ibezapolstat's competitive profile continues to evolve and strengthen, we'll continue to navigate successfully through these challenging times in the macroeconomic environment in our industry sector. Back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the first quarter of 2026. Rob.
Thanks, Dave. Our financial results for the first quarter ended March 31, 2026, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $9.3 million compared to $7.6 million as of December 31, 2025. During the quarter, the company raised a total of approximately $3.1 million of gross proceeds through purchases under its equity line of credit. Research and development expenses for the three months ended March 31, 2026, were $0.3 million. Compared to $0.6 million for the three months ended March 31, 2025, a decrease of $0.3 million.
The decrease was primarily due to a decrease in manufacturing costs of $0.1 million and a decrease in consulting related costs of $0.2 million as a result of prior year trial preparation related expenses. General and administrative expenses for the three months ended March 31, 2026 were $1.4 million. That was compared to $1.6 million for the three months ended March 31, 2025, a decrease of $0.2 million. The decrease was primarily due to a $0.1 million decrease in professional fees and a $0.1 million decrease in legal costs. The company reported a net loss of $1.7 million or $0.62 per diluted share for the three months ended March 31, 2026.
That was compared to a net loss of $2.1 million or $2.15 per diluted share for the three months ended March 31, 2025, all for the reasons previously mentioned. The company had 3,389,106 shares outstanding as of March 31, 2026. With that, I'll turn the call back over to Dave. Dave?
Thanks. Thanks, Rob, and to all of you for joining us today. Before bringing our operator, Melissa, back to open the call for questions, I'm pleased to introduce to our call Dr. Michael Silverman, our Medical Director, and Bob DeLuccia, our Executive Chairman, to assist with Q&A regarding our rCDI program or any other matters of an R&D nature. Bob and Michael can also respond to questions regarding the recent FDA guidelines for pivotal phase III trials in C. difficile. Now I'd like to turn the call over to our operator, Melissa, to open the call for any questions. Melissa?