Greetings. Welcome to the Acurx Pharmaceuticals Third Quarter 2026 Financial Results. At this time, all participants will be in listen-only mode. Question- and- answer session will follow the formal presentation. If anyone should require operator assistance during today's conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. At this time, I'll now turn the conference over to Rob Shawah, Chief Financial Officer. Please go ahead.
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 third quarter 2026, which is available on our website at acurxpharma.com. Joining me today is David Luci, President and CEO of Acurx, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from the third quarter ended September 30th, 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 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 today, Thursday, November 12th. 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, November 12th, 2026. 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 third quarter 2026, 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 Senior Medical Advisor, Dr. Michael Silverman, have joined us today and will be available to answer questions about our ongoing clinical trial in patients with recurrent C. diff infection. First, I'd like to briefly summarize just a few of our key activities for the third quarter of 2026, or in some cases, shortly thereafter.
First, in July 2026, the company's R&D team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single phase III study in acute C. difficile infection, or CDI, and its acceptability as a pivotal trial for filing a new drug application. We reported the outcome of this meeting in 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 we complete a single phase III trial, called ASPIRE, for the treatment of acute CDI and the reduction of recurrence, and the data from the PATHFINDER trial that is currently enrolling patients in recurrent CDI.
Based on our discussions, FDA will focus on whether our clinical efficacy data from PATHFINDER and ASPIRE is robust enough to support an NDA submission. Second, on September 29th of this year, we began enrolling patients in the PATHFINDER 20-patient ground-breaking clinical trial in multiply recurrent CDI. This trial was acknowledged by FDA as being significant, and along with robust results from our ASPIRE trial, may form the basis for a potential approval for the treatment of both acute CDI and prevention of recurrence.
The PATHFINDER trial is fully funded, and if successful, will elevate the product profile of ibezapolstat. If the PATHFINDER trial is successful, we may have the flexibility to conduct a pivotal phase III trial, or PATHFINDER II, in recurrent CDI under the FDA's LPAD pathway, instead of conducting the ASPIRE trial in acute CDI to gain an approval. A successful PATHFINDER trial may lead to an opportunity to gain approval with a smaller phase III program, and the ASPIRE trial in that scenario would become a post-approval supplemental NDA submission for the broader CDI population.
Thirdly, in August 2026, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary or brand name for ibezapolstat, which is CIFBEZY. These initial milestones will form the basis for the commercial identity of ibezapolstat as the company prepares to advance toward a phase III trial or trials and commercialization. Fourth, in September, the company announced its presentation of a scientific poster at the International C. difficile Symposium, demonstrating superior in vitro kill kinetics of ibezapolstat versus standards of care, vancomycin and fidaxomicin, against C. difficile, including vancomycin-resistant Enterococcus. These findings demonstrate that Enterococcus creates a protective shield that actively impairs C. difficile killing using standard of care antibiotics, but not with ibezapolstat. Ibezapolstat maintained superior bactericidal activity, including further decreasing C. difficile toxin B expression while simultaneously eradicating vancomycin-resistant bacterial growth.
Fifth, in July, we signed a continuation of our scientific partnership with Leiden University Medical Center in Holland to advance development of Acurx's DNA Pol III inhibitors. This new partnership builds on the previously reported successful results from the innovative research grants received in August 2021 and November 2025 from Health Holland to Leiden University and Acurx. This continuing partnership will enable further mechanistic research into DNA Pol III inhibition to accelerate the development of novel new antibiotics that are systemically active against a range of Gram+ pathogens resistant to currently available antibiotics. This new research also aims to generate the first-ever 3D structure of Pol C 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.
Also in July, a presentation of scientific data by Dr. Kevin Garey and his laboratory team at 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 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 ibez significantly more effective at killing C. diff than either vancomycin or fidaxomicin. In October, we announced the publication in the ASM, American Society for Microbiology, Spectrum Journal, confirming data on our DNA Pol III inhibitor pipeline of antibiotics, demonstrating a potential microbiome-sparing class effect. This was the first-ever head-to-head comparison of gut microbiome changes associated and reduced MRSA bacterial burden while preserving microbiome metabolic function, in contrast to the marked disruption by linezolid.
Eighth, in October, Acurx presented at the Pipeline and Innovation Theater at IDWeek, the 2026 Scientific Conference of the Infectious Diseases Society of America, held in Washington, D.C., October 21- 24. Our Executive Chairman, Bob DeLuccia, and Dr. Gino Girardi, Acurx Director of Clinical Research, presented an update on our progress and highlighted the open enrollment of our PATHFINDER trial at clinical research sites across the country. Bob and Gino also discussed our previously announced FDA guidance from our July 2026 FDA Type C Meeting to discuss ibezapolstat phase III clinical program, including the potential to submit an NDA based on a single phase III trial and a clinical trial design intended to support indications for both the acute treatment and the reduction of recurrence of CDI.
The predominant theme at the conference was a call to action to address antimicrobial resistance and the need for new antibiotics that respect both antimicrobial and microbiome stewardship. Acurx is at the forefront of pioneering microbiome stewardship by discovering and developing innovative narrow-spectrum antibiotics that cause minimal gut dysbiosis, a paradox with today's antibiotics. In August of this year, the company received approval from the Japan Patent Office and the Mexico Patent Office, respectively, for newly granted patents that protect Acurx's DNA Pol III inhibitors, including composition of matter, method of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent additions to the company's expanding series of granted patents in the U.S. and abroad.
To date, we've secured U.S. and international patents, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key assets of the company's ibezapolstat and ACX-375C program targeting DNA Pol III. The ibezapolstat patents currently run through June 2042, subject to extensions that may be available. More importantly, the Company has 10 years of regulatory exclusivity from the date of FDA approval based on its designation as a QIDP product and status as a new molecular entity. Additional country-level patents remain under review. We continue to identify and pursue funding opportunities for our phase III pivotal trial program for ibez for the treatment of both acute CDI and the reduction of recurrence. We've got several initiatives underway to this end and will report our progress in future updates.
As we've continually reported, ibezapolstat clinical and non-clinical results continue to outperform in a serious and life-threatening infectious disease called C. difficile bacteria that the CDC categorizes as a serious threat and calls for new classes of antibiotics for initial treatment that have a low incidence of recurrence. Furthermore, IBZ has FDA QIDP and fast-track designations for the treatment of CDI, as well as SME status in the EU. All Acurx compounds in preclinical development are eligible for QIDP and fast-track designations and target Gram+ infections classified as serious threat priorities by the CDC and the FDA. In closing today, as you may expect, we're very excited to report the start of enrollment for our ground-breaking [PATHFINDER trial] and the continued successful development of IBZ across the board.
With these regulatory pathways forward, and as IBZ's competitive profile continues to evolve and strengthen, we remain confident that we'll continue to successfully navigate through these challenging times in our industry sector. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the third quarter of 2026. Rob?
Thanks, Dave. Our financial results for the third quarter ended September 30th, 2026, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $9.7 million. That was compared to $7.6 million as of December 31, 2025. During the quarter, the company raised a total of approximately $1.5 million of gross proceeds through our equity line of credit. Research and development expenses for the three months ended September 30th, 2026, were $1.1 million. That was compared to $0.4 million for the three months ended September 30, 2025, an increase of $0.7 million. The increase was due primarily to an increase in consulting costs of $0.7 million as a result of costs associated with the new recurrent CDI trial program.
For the nine months ended September 30, 2026, research and development expenses were $2.5 million compared to $1.6 million for the nine months ended September 30, 2025. The $0.9 million increase was due primarily to a $0.8 million increase in consulting fees and a $0.1 million increase in manufacturing costs, both of which as a result of costs associated with the new recurrent CDI trial program. General and administrative expenses for the three months ended September 30th, 2026, were $1.5 million compared to $1.6 million for the three months ended September 30, 2025, a decrease of $0.1 million. The decrease was primarily due to a $0.1 million decrease in professional fees, a $0.1 million decrease in legal costs, offset by a $0.1 million increase in compensation-related expenses.
For the nine months ended September 30, 2026, general and administrative expenses were $4.1 million compared to $4.9 million for the nine months ended September 30, 2025, a decrease of $0.8 million. The decrease was due primarily to a $0.4 million decrease in professional fees, a $0.3 million decrease in legal costs, and a $0.1 million decrease in compensation-related expenses. The company reported a net loss of $2.6 million, or $0.49 per diluted share, for the three months ended September 30, 2026. That was compared to a net loss of $2 million, or $1.23 per diluted share, for the three months ended September 30, 2025.
For the nine months ended September 30, 2026, the company reported a net loss of $6.5 million, or $1.59 per diluted share, compared to $6.4 million, or $5.01 per diluted share, for the nine months ended September 30, 2025, all for the reasons previously mentioned. The company had 5,879,237 shares outstanding as of September 30, 2026. With that, I'll turn the call back over to Dave. Dave?
Thanks, Rob, and to all of you joining us today. Before bringing our operator back to open the call for questions, I'm pleased to welcome to our call our Senior Medical Advisor, Dr. Michael Silverman, and our Executive Chairman, Bob DeLuccia, to assist with Q&A regarding our recurrent C. diff clinical development program. Also, I received several questions from stakeholders in the past weeks who could not attend this call, so I'd like to address them in advance of turning the call over for further questions. Questions and answers for stakeholders are as follows. Question one: Why did Acurx file a bylaw amendment to reduce the quorum requirement for stockholder votes? The answer is, to be clear, stockholders maintain their right to vote, one vote for each share that they own. The bylaw amendment doesn't change that.
The bylaw amendment changes the quorum requirement to transact business from a majority to 33.33%. Quorum means this is the level of voting required to transact business and carry resolutions that are approved by a majority of the stockholders who vote. With a fractionated shareholder base as we have, we'll be able to transact business without significant and costly delays and business interruptions if many shareholders do not vote. Question two, what steps are the company taking to maintain Nasdaq listing compliance? The company is continuing to enroll patients in the recurrent C. diff trial, positive data from which we believe will elevate our product profile and stock price, given the size of the market and significant unmet medical need. In addition, the company has a series of R&D-related press releases anticipated over the next several months that may drive value.
We continue to discuss partnering initiatives which are currently active, any of which we believe may drive value. Question three, the financial situation. Does the company have enough cash to continue the rCDI trial without further funding? The answer is yes. Acurx has enough funds to pay for the rCDI trial, assuming the trial is fully enrolled in the third quarter of 2027. Acurx has 12 months of funds secured, and Acurx may raise cash in the next 12 months through ELOC drawdowns, equity offerings, or non-dilutively through partnerships or government grants. Question four, when can stockholders expect an update on the currently enrolling rCDI trial? Depending on the rate of enrollment, stockholders can expect an update when enrollment is completed sometime in the second half of 2027. Question number five, is the company pursuing large pharma partnerships, and if anything, can be publicly disclosed?
The answer is that Acurx continues to pursue large, medium, and small pharma company partnerships, but nothing yet has progressed to the level of public disclosure. We're confident that a partnership, public or private, may be possible if the terms are acceptable to our stockholders and our board. This possibility will be enhanced as ibezapolstat continues to successfully meet its development milestones. Question six, what is management's plan to raise shareholder value? Management will continue to enroll patients in its rCDI clinical trial in study centers across the U.S. and report top-line data as soon as possible after enrollment's been completed and the patients are fully evaluated. Although management can't control the timing of enrollment, the stock market, or our stock price, we believe strong rCDI data will generate shareholder value and increase partnership interest. Question seven, what gives management confidence in the development activities over the next six months?
The rCDI trial continuing enrollment in an area of high unmet medical need, where our current data shows no recurrences to patients who have been dosed with ibezapolstat, who are cured, with regulatory successes ongoing in the U.S. and Europe anticipated, and continued in vitro developments generated at University of Houston and Leiden University Medical Center, two of our scientific partners. We also will participate in appropriate scientific conferences, such as the upcoming Peggy Lillis C. diff Foundation Annual Conference to be held on November 19th and 20th, where our Chairman, Bob DeLuccia, on the call today, will provide opening remarks to this third annual scientific educational event to provide clinicians, scientists, nurses, pharmacists, and the industry on all things C. diff, including an update on ibezapolstat's development progress. This virtual event coincides with CDC's designation of November as C. diff Awareness Month.
Although we have no control over the company's stock price, we believe these initiatives, if successful, will drive value. We hope the foregoing Q&A is fully responsive to the questions that have been raised today. Now back to the operator, Rob, to open the call for questions. Rob?
Thank you. We will now be conducting the question- and- answer session. If you would like to ask a question at this time, you may press star one on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you would 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. Our first question comes from the line of Matthew Keller with H.C. Wainwright. Please proceed with your questions.
Hey, good morning. Thanks for taking my question. Thanks very much for the update, but I was wondering, we are discussing PATHFINDER II as maybe being prioritized over ASPIRE 1 in the future. I was wondering what would drive that decision to prioritize one program or the other, maybe from PATHFINDER I or other information that you might have.
Sure. Thank you for the question, Matthew. We are going to have to call an audible somewhere along the way, perhaps. Maybe I should answer this in kind of how things could play out. If, for example, we get a government grant for the ASPIRE trial, phase III, then we would obviously, we are phase III ready for ASPIRE currently, so we would start that trial right away. If, however, the ASPIRE trial is not funded at the point in time when we meet the FDA, after the 20-patient rCDI trial, if the data is good from the rCDI trial, we may get the green light from FDA to continue with PATHFINDER II, with a limited patient population opportunity, making the PATHFINDER II journey much shorter and much less costly, and leading to opportunity for premium pricing.
We are going to have to continue to ride the two development pathways in parallel until we see how the facts play out.
No, totally makes sense. Thanks for the additional clarity.
No problem.
Thank you. As a reminder, to ask a question, you may press star one. The next question is from the line of James Molloy with Alliance Global. Please proceed with your question.
Hello, this is Laura on for Jim Molloy. Thank you for taking our questions. Just two from us. Just a bit more on the PATHFINDER II trial. I know it's a bit early still, but could you provide a bit more insight on what the study design might look like and how long you think this trial might run and any potential costs involved? Also, what do you think the FDA might need to see in order, in the current PATHFINDER trial, in order to approve the phase III PATHFINDER II under the LPAD pathway for approval? Thank you.
Sure. Thank you for the question, Laura. As you suggest, it is a bit early to talk about the timing and total cost. We could talk in broad-scale ranges. Depending on the data from the 20-patient trial, the next, the PATHFINDER II study may be in the neighborhood of 350 patients in total, and it may take a year and a half or two years to fully enroll, and that would be an international study, and it would be up against an active comparator. Currently considering, although this could change, currently considering VOWST as a lead possibility there. What will FDA be focused on when they review the 20-patient data?
The lion's share of the cost is the recurrence trap in these C. diff patients. Of the $5 billion in federal spend annually in the U.S. on C. difficile, the lion's share of that, close to $3 billion, is in patients with recurrent C. diff, because you end up recurring, and you get into this trap where the recurrences lead to further recurrences and become more and more life-threatening. So, recurrent C. diff has a tremendous focus with BARDA, with the FDA, with other private sponsors of things like REBYOTA and VOWST.
So, we think if we can show that our long-term observation of patients, of the 20 patients with recurrent C. diff, shows non-inferiority or even possibly superiority, in terms of lack of recurrences over, in a meta-analysis sort of sense, over the other programs that are approved currently to treat recurrent C. diff, we think the FDA would see an advantage to pushing this forward, because that would save up to 29,000 lives a year and billions of dollars to public health.
Great. Thank you so much.
Thank you, Laura.
Thank you. Ladies and gentlemen, this will conclude our question-and-answer session and will also conclude today's call. We thank you for your participation and have a wonderful day.
Thank you, Rob.