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DATE
Thursday, Nov. 12, 2026
CALL PARTICIPANTS
- Chief Financial Officer - Robert G. Shawah
- President and CEO - David Luci
- Executive Chairman - Bob DeLuccia
- Senior Medical Advisor - Dr. Michael Silverman
TAKEAWAYS
- Cash Balance -- $9.7 million as of Sept. 30, 2026, compared to $7.6 million on Dec. 31, 2025.
- Equity Funding -- $1.5 million in gross proceeds raised during the third quarter via an equity line of credit.
- Net Loss -- $2.6 million for the third quarter, or $0.49 per diluted share, compared to $2 million, or $1.23 per share, in the prior year.
- Nine-Month Net Loss -- $6.5 million, or $1.59 per diluted share, for the period ended Sept. 30, 2026.
- R&D Expenses -- $1.1 million for the third quarter, representing a $700,000 increase due to higher consulting costs for the recurrent CDI trial program.
- General and Administrative Expenses -- $1.5 million for the third quarter, a $100,000 decrease primarily due to lower professional and legal fees.
- Shares Outstanding -- 5.88 million as of Sept. 30, 2026.
- PATHFINDER Trial Enrollment -- Started on Sept. 29, 2026, targeting 20 patients with recurrent Clostridium difficile infection (CDI).
- Cash Runway -- 12 months of secured funding, which management indicated is sufficient to complete the PATHFINDER trial by the third quarter of 2027.
- Patent Portfolio -- Ibezopolstat patents extend through June 2042, supplemented by 10 years of regulatory exclusivity as a New Molecular Entity.
- Regulatory Strategy -- Potential to file a New Drug Application based on a single Phase III trial (ASPIRE) combined with PATHFINDER data.
- LPAD Pathway Opportunity -- Potential to seek approval via the Limited Population Pathway for Antibacterial and Antifungal Drugs using a second PATHFINDER study.
- PATHFINDER 2 Parameters -- Anticipated to include approximately 350 patients with an international enrollment timeline of 1.5 to 2 years.
- Trademark Status -- Syfbezi received conditional acceptance from the FDA and a trademark allowance from the U.S. Patent and Trademark Office.
- Quorum Requirement -- Reduced to 33.3% from a majority to facilitate the transaction of business with a fractionated shareholder base.
- International Patents -- Granted in Japan and Mexico during August 2026, protecting DNA POL3C inhibitors and pharmaceutical compositions.
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RISKS
- CEO Luci stated, "with a fractionated shareholder base as we have, we will be able to transact business without significant and costly delays and business interruptions if many shareholders do not vote," noting the potential impact of inaction on corporate governance.
SUMMARY
Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) is a clinical-stage biopharmaceutical company developing a new class of antibiotics to treat bacterial infections. Management reported the start of enrollment for its PATHFINDER clinical trial, a 20-patient study targeting recurrent Clostridium difficile infection, which is expected to finish enrollment in the second half of 2027. The company ended the third quarter with $9.7 million in cash, providing a 12-month runway supported by a $1.5 million capital raise through an equity line of credit. Strategic initiatives focus on navigating regulatory pathways with the FDA, including the potential for a single Phase III trial or the use of the LPAD pathway for ibezopolstat.
- Management is evaluating two parallel development strategies for ibezopolstat, including the ASPIRE trial for acute CDI and the PATHFINDER program for recurrent cases.
- CEO Luci stated that a "successful PATHFINDER trial may lead to an opportunity to gain approval with a smaller Phase III program," potentially reducing development costs and timelines.
- Scientific data from the University of Houston suggests that ibezopolstat allows beneficial gut microorganisms to repopulate the microbiome, which may help prevent infection recurrence.
- The company extended its research partnership with Leiden University Medical Center to advance DNA POL3C inhibitors and develop antibiotics targeting resistant gram-positive pathogens.
- Luci noted that management remains focused on pursuing partnerships with large- and medium-sized pharmaceutical companies as clinical milestones are met.
- Ibezopolstat maintains 10 years of regulatory exclusivity from its potential FDA approval date due to its status as a New Molecular Entity and a Qualified Infectious Disease Product.
INDUSTRY GLOSSARY
- Ibezopolstat: A clinical-stage antibiotic candidate that targets the DNA polymerase IIIC enzyme to treat C. difficile infections.
- CDI: Clostridium difficile infection, a serious and potentially life-threatening bacterial infection of the colon.
- LPAD Pathway: Limited Population Pathway for Antibacterial and Antifungal Drugs, an FDA regulatory pathway designed to expedite the approval of antibiotics for serious infections in limited patient populations.
- QIDP: Qualified Infectious Disease Product, an FDA designation that provides incentives for antibiotic development, including eligibility for Fast Track designation and extended market exclusivity.
- DNA POL3C: DNA polymerase IIIC, an enzyme essential for DNA replication in certain gram-positive bacteria and the primary target of Acurx's antibiotic pipeline.
- rCDI: Recurrent Clostridium difficile infection, characterized by multiple episodes of infection after initial treatment.
- Syfbezi: The conditionally accepted brand name for ibezopolstat.
Full Conference Call Transcript
Operator: Greetings. Welcome to the AcuRx Pharmaceuticals Third Quarter 26 Financial Results. At this time, all participants will be in listen-only mode. A question-and-answer session will follow the formal presentation. Please note that this conference is being recorded. At this time, I will now turn the conference over to Robert G. Shawah, Chief Financial Officer. Please go ahead.
Robert G. Shawah: Thank you, Robert. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the third quarter 26 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 will provide some highlights of the financials from the third quarter ended September 30, and then turn the call back over to David for his closing remarks.
As a reminder, during today's call, we will be making certain forward-looking statements, which are based on current information, assumptions, estimates, 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 12. 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 is accurate only as of the date of this live broadcast. Today, 11/12/2026. I will now turn the call over to David Luci, David?
David Luci: Thanks, Robert. Good morning, everyone. And thank you so much for joining us to review our financial results for the third quarter 26. And also to hear some recent updates on our continuing progress. Then we would 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 would 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 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 3 press release. Briefly, the FDA stated that it is open to further discussion on the totality of evidence from the ibezopolastat clinical development program at a pre NDA meeting after we complete a single Phase III trial called ASPIRE.
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 29, of this year, we began enrolling patients in the Pathfinder 20-patient groundbreaking clinical trial in mostly 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--if the Pathfinder trial is successful, we may have the flexibility to conduct a pivotal Phase III trial or a Pathfinder 2 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, August 2026, the company received FDA conditional acceptance in U.S.
PTO trademark allowance of its proprietary or brand name for ibezopolostat which is Syfbezi. These initial milestones will form the basis for the commercial identity of ibezopolstat. 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 ibezopolstat 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 ibezopolstat. Ibezopolstat 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 POL3C inhibitors. This new partnership builds on the previously reported successful results from the innovative research grants received in August 2021 and November 2025 from HealthHolland to Leiden University and Accurax. This continuing partnership will enable further mechanistic research into DNA POL3C 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 POL3C from methicillin-resistant Staphylococcus aureus (MRSA) 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 the following treatment in his state-of-the-art laboratory model. With ibezopolstat the beneficial microorganisms in the gut have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence.
In addition, ibezopolstat and fidaxomicin were superior in biofilm experimental models with ibezopolstat significantly more effective at killing C. difficile than either vancomycin or In October, we announced the publication in the ASM, American Society for Microbiology, Spectrum Journal, confirming data on our DNA POL3C 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 POL3C inhibitors. To linezolid in a thigh infection model. ibezopolstat demonstrated good solubility and systemic exposure 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, October 21 to 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 ibezopolstat 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 drug 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 POL3C 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. Today, we have 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 ibezopolstat and ACX-375C program.
Targeting DNA POL3C. ibezopolstat 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 ibezopolstat for the treatment of both acute CDI and the reduction of recurrence. We have got several initiatives underway to this end and we will report our progress in future updates.
As we have continually reported, ibezopolstat's clinical and nonclinical 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, ibezopolstat 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 positive infections, classified as serious threat priorities by the CDC and the FDA.
So in closing today, as you may expect, we are very excited to report the start of enrollment for our groundbreaking PATHFINDER trial. And the continued successful development of ibezopolstat across the board. With these regulatory pathways forward, as ibezopolstat's competitive profile continues to evolve and strengthen, we remain confident that we will continue to successfully navigate through these challenging times in our industry sector. And now back to our CFO, Robert G. Shawah, to guide you through the highlights of our financial results for the third quarter of 2026. Robert?
Robert G. Shawah: Thanks, David. 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 3 months ended September 30, 2026, were $1.1 million That was compared to $400,000 for the 3 months ended September 30, 2030, an increase of $700,000.
The increase was due primarily to an increase in consulting costs of $700,000 as a result of costs associated with the new recurrent CDI trial program. For the 9 months ended September 30, 2026, research and development expenses were $2.5 million compared to $1.6 million for the 9 months ended September 30, 2025. The $900,000 increase was due primarily to an $800,000 increase in consulting fees and a $100,000 increase in manufacturing costs. Both of which are a result of costs associated with the new recurrent CDI trial program. General and administrative expenses for the 3 months ended September 30, 2026, were $1.5 million compared to $1.6 million for the 3 months ended September 30, 2025. a decrease of $100,000.
The decrease was primarily due to a $100,000 decrease in professional fees, a $100,000 decrease in legal costs, offset by a $100,000 increase in compensation related expenses. For the 9 months ended September 30, 2026, general and administrative expenses were $4.1 million compared to $4.9 million for the 9 months ended September 30, 2025. a decrease of $800,000. The decrease was due primarily to a $400,000 decrease in professional fees, a $300,000 decrease in legal costs, and a $100,000 decrease in compensation related expenses.
The company reported a net loss of $2.6 million or $0.49 per diluted share for the 3 months ended September 30, 2026, That was compared to a net loss of $2 million or $1.23 per diluted share for the 3 months ended September 30, 2025. For the 9 months ended September 30, 2026, the company reported 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 9 months ended September 30, 2030, all for the reasons previously mentioned. The company had 5.88 million shares outstanding as of September 30, 2026. With that, I will turn the call back over to David. David?
David Luci: Thanks, Robert, and to all of you joining us today. Before bringing our operator back to open the call for questions, I am 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 have received several questions from stakeholders in the past weeks who could not attend this call. So I would like to address them in advance of turning the call over for further questions. Questions and answers for stakeholders are as follows: Question 1, why did Acurx 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, 1 vote for each share, that they own. The bylaw amendment does not 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. So with a fractionated shareholder base as we have, we will be able to transact business without significant and costly delays and business interruptions if many shareholders do not vote. Question 2, 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 3. 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 4, looking, can stockholders expect--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 5, is the company pursuing large pharma partnerships and if so, what 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 are confident that a partnership, public or private, may be possible if returns are assessed as acceptable to our stockholders and our Board. This possibility will be enhanced as idezipolstat continues to successfully meet its development milestones. Question 6. 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 has been completed and the patients are fully evaluated.
Although management cannot 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 7, what gives management confidence in the development activities over the next 6 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 ibezopolstat. 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, 2 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 19, where our Chairman, Bob DeLuccia, on the call today, will provide opening remarks to this third annual scientific education event to provide clinicians, scientists, nurses, pharmacists, and industry on all things C. diff, including an update on ibezopolstat'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 to date. And now back to the operator, Robert, to open the call for questions. Robert.
Operator: Thank you. We will now be conducting the question and-answer session. And our first question comes from the line of Matthew Keller with H. C. Wainwright. Please proceed with your questions.
Matthew Keller: So thanks very much for the update. But I was wondering, we have been discussing Pathfinder 2 as maybe being prioritized over ASPIRE in the future. Was wondering what would drive that decision to prioritize 1 program over the other, maybe from Pathfinder 1 or other--other information that you might have.
David Luci: Sure. Thank you for the question, Matthew. So we are we are going to have to call an audible somewhere along the way. Perhaps. So maybe I should answer this in terms of how things could play out. So if, for example, we get government grant for the ASPIRE trial, Phase III, then we would obviously, we are 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 are going to have to continue to ride the 2 development pathways in parallel until we see how the facts play out.
Matthew Keller: Totally makes sense. Thanks for the additional clarity.
David Luci: No problem. Thank you.
Operator: As a reminder, to ask a question, you may press 1. The next question is from the line of James Molloy with Alliance Global. Please proceed with your questions.
James Molloy: Hello. This is Laura on for Jim Molloy. Thank you for taking our questions. So just 2 from us. So just a bit more on the PATHFINDER 2 trial. I know it is 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, do you think the FDA might need to see in order in the current Pathfinder trial in order to approve the Phase III PATHFINDER 2 under the LPAD pathway for approval. Thank you.
David Luci: Sure. Thank you for the question, Laura. So as you suggest, it is 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 1.5 or 2 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.
And 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. So of the $5 billion in federal spend annually in The U.S. on C. difficile, the lion's share of that 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 Recurrent C. diff has had 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, in a 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.
James Molloy: Great. Thank you so much.
David Luci: Thank you, Laura.
Operator: 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, Robert.
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