Acurx Pharmaceuticals, Inc. (ACXP) Q3 2026 Earnings Call Transcript

Thank you.

Welcome to the Acurix Pharmaceuticals 3rd Quarter 2026 Financial Results. At this time, all participants will be in listening-only mode. The 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 Shawa, 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 acorexpharma.com. Joining me today is David Lucci, President and CEO of Acorex, who will start by providing a corporate update in 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. There 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 questioned not to place undue reliance on these forward-looking statements. And AccurX disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that's only as of the date of this live broadcast, today, November 12, 2026. I'll now turn the call over to Dave Lucci. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the third quarter of 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 26, or in some cases, shortly thereafter. First, in July 26, 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 3 press release. Briefly, the FDA stated that it's open to further discussion on the fatality of evidence from the Obesipulstat Clinical Development Program at a pre-MDA 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 a bezopolstat. 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. So 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 26, the company received FDA conditional acceptance and USPTO trademark allowance of its proprietary or brand name for Ivesipolstat, which is CIF-EZI. These initial milestones will form the basis for the commercial identity of Ivesipolstat 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 pill kinetics of ibezopulstat versus standards of care vancomycin and fidaxomycin against C. difficile, including vancomycin-resistant enterococcus. These findings demonstrate that enteropacus creates a protective shield that actively impairs C-gifocele killing using standard of care antibiotics, but not with ibezapolstat. ibezapolstat maintained superior bactericidal activity, including further decreasing C-gifocele 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 Acurex's DNA-PAL3C inhibitors. This new partnership builds on the previously reported successful results from the innovative research grants received in August 21 and November 25 from Health Holland to Leiden University and Acurex. This continuing partnership will enable further mechanistic research into DNA Foul3C inhibition to accelerate the development of novel new antibiotics that are systemically active against a range of gram-positive pathogens resistant to currently available antibiotics. This new research also aims to generate the first-ever 3D structure of polyseed from methicillin-resistant staph aureus in complex with an acorex 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 Gary and his laboratory team at University of Houston College of Pharmacy demonstrated the following treatment in his state-of-the-art laboratory model with Ivesipulstat, the beneficial microorganisms in the gut have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, ibezipolstat and finaxomycin were superior in biofilm experimental models, with ibez significantly more effective at killing C. diff than either fincomycin or finaxomycin. In October, we announced the publication in the ASM, American Society for Microbiology, Spectrum Journal, confirming data on our DNA PAL-3C 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 with our preclinical PAL-3C inhibitors to linizolid in a thigh infection model. IBEZ demonstrated good solubility and systemic exposure and reduced MRSA bacterial burden while preserving microbiome metabolic function in contrast to the marked disruption by linizolid. 8th, in October, ACREX presented at the Pipeline and Innovation Theater at ID Week, the 2026 Scientific Conference of the Infectious Disease of America, held in Washington, October 21 to 24. Our Executive Chairman, Bob DeLuccia, and Dr. Gino Girardi, ACREX 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 Gina also discussed our previously announced FDA guidance from our July 26 FDA Type C meeting to discuss a Vezipulstat Phase III clinical program, including the potential to submit an NDA based on a single Phase III trial. And our clinical trials designed 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. After X 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 Acrex's DNA PAL-3C inhibitors, including composition of matter, method of use, and pharmaceutical compositions, which further strengthen Acrex'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. Today, we've secured U.S. and international patents, including Australia, Canada, Europe, Israel, India, Japan, Korea, and Mexico, all of which protect key aspects of the companies like Beza Polestat and ACX-375C program targeting DNA PAL-3C. The Avesa-Pulsat patents currently run through June 2042, subject to extensions that may be available. And 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 IBES for the treatment of both acute CDI and the reduction of recurrence. We've got several initiatives underway to this end, and we'll report our progress in future updates. As we've continually recorded, IBES 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, IBES has FDA QIDP and fast-track designations for the treatment of CDI, as well as SME status in the EU. All Acurex compounds in preclinical development are eligible for QIP and fast track designations and target grand positive infections classified as serious threat priorities by the CDC and the FDA. So in closing today, as you may expect, we're very excited to report the start of enrollment for our groundbreaking Pathfinder trial and the continued successful development of IBES across the board. With these regulatory pathways forward, as IBED'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. And now back to our CFO, Rob Schaller, 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 30, 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 30, 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 TDI 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 three months ended September 30, 2026. For $1.5 million, compared to $1.6 million for the three months ended September 30, 2025, a decrease of $1.1 million. The decrease was primarily due to a $1.1 million decrease in professional fees, a $1.1 million decrease in legal costs, offset by a $1.1 million increase in compensation-related expenses. For the nine months ended September 30, 2026, general 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. The company reported a net loss of $2.6 million, or 49 cents 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 DeLucci, to assist with Q&A regarding our recurrent C. diff clinical development program. Also, I've 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 AccurX file a bylaw amendment to reduce the quorum requirement for stockholder votes? So the answer is, to be clear, stockholders maintain their right to vote, one vote for each share that they owe. 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 the majority of the stockholders who vote. So, 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. Accurex has enough funds to pay for the RCDI trial, assuming the trial is fully enrolled in the third quarter of 2027. Accurex has 12 months of funds secured, and Accurex may raise cash. In the next 12 months through ELAC drawdowns, equity offerings, or non-dilutably through partnerships or government grants. Question 4, what can stockholders expect, when can stockholders expect an update on the currently enrolling RCDI trial? Depending on the rate of enrollment, stockholders expect an update when enrollment is completed Sometime in the second half of 27. Question number five, is the company pursuing large pharma partnerships, and if anything, can be publicly disclosed? The answer is that Accurate 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 IBEZA-FOLSTAT 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 Where our current data shows no recurrences. To patients who have been dosed with RF as a pulstat, you know, 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 Willis C.GIF Foundation annual conference to be held on November 19th and 20th, where our chairman, Bob DiLucci, on the call today will provide opening remarks to this third annual scientific education event to provide clinicians, scientists, nurses, pharmacists, and the industry on all things C.GIF, including an update on Ivesa Polostad's development progress. This virtual event coincides with CDC's designation of November as C. D.I.P. 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 to date. And now back to the operator, Rob, to open the call for questions. Rob?

Thank you. We'll now be conducting the question and answer session. If you'd like to ask a question at this time, you may press star 1 on your telephone keypad, and a confirmation tone to indicate your line is in the question queue. You may press star 2 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 comes from the line of Matthew Keller with H.C. Wainwright. Please receive your questions.

Hey, good morning. Thanks for taking my question. So, thanks very much for the update. But I was wondering, you know, discussing Pathfinder 2 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 1 or other information that you might have. Sure. Thank you for the question, Matthew. So, you know, we're going to have to call an audible somewhere along the way, perhaps. So, you know, maybe I should answer this in, you know, kind of how things could play out. So, if, for example, we get a government grant for the ASPIRE trial, Phase 3, you know, then we would obviously we're Phase 3 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 2 with a limited patient population opportunity. Making the Pathfinder 2 journey much shorter and much less costly and leading to opportunity for premium pricing. So we're 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 1. The next question is from the line of James Malloy with Alliance Global. Please receive your questions.

Hello, this is Laura on for Jim Malloy. Thank you for taking our questions. So just two from us. So just a bit more on the Pathfinder 2 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? And also, what do you think the FDA might need to see 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. So, as you suggest, it's a bit early to talk about the timing and total cost. We could talk in broad-scale ranges. So, depending on the data from the 20-patient trial, the next, the Pathfinder 2 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 VAUST as a lead possibility there. And what will FDA be focused on when they review the 20-patient data? You know, the lion's share of the cost. is the recurrence trap in these C. diff patients. So, you know, of the $5 billion in, you know, federal spend annually in the U.S. on C. difficile, the lion's share of that, you know, close to $3 million 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 recurrency diff, you know, has had, you know, a tremendous focus with BARDA, with the FDA, with other private sponsors of things like Rebiota and VAUST. Thank you. We think if we can show that our long-term observation 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.