What changed in this filing

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Item 1. Business

2026-03-12 compared with 2025-03-17 · 39 added, 48 removed, 839 unchanged (9% of the section changed)

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There is an inadequate research and development pipeline in the face of rising levels of resistance, and urgent need for additional measures to ensure equitable access to new and existing vaccines, diagnostics and medicines.

We believe we are developing the first DNA pol IIIC inhibitor to enter Phase 3 clinical trials and have clinically validated the efficacy of our lead pol IIIC antibiotic candidate in a Phase 2 clinical trial.

We believe we are developing the first DNA pol IIIC inhibitor that is ready to enter Phase 3 clinical trials and have clinically validated the efficacy of our lead pol IIIC antibiotic candidate in a Phase 2 clinical trial.

Pol IIIC is the primary catalyst for DNA replication of several Gram-positive bacterial cells.

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a Bioterrorism Category A Threat-Level pathogen).

We have now “de-risked” this new class of antibiotics through our drug development activities as we advance to Phase 3 clinical trials by demonstrating proof of principal in Phase 2 human efficacy studies that demonstrate comparable efficacy to the standard of care with no drug related side effects and a positive impact on the microbiome of patients with C.

We have now “de-risked” this new class of antibiotics through our drug development activities as we advance to Phase 3 clinical trials by demonstrating proof of principle in Phase 2 human efficacy studies that demonstrate comparable efficacy to the standard of care with no drug related side effects and a positive impact on the microbiome of patients with C.

difficile infections.

We expect to partner with a fully-integrated pharmaceutical company for late-stage clinical trials and commercialization or conduct Phase 3 clinical trials prior to such partnership and continue to review partnership opportunities on an ongoing basis up to FDA approval.

Our lead antibiotic candidate, ibezapolstat (formerly named ACX-362E), has a novel mechanism of action that targets the pol IIIC enzyme, a previously unexploited scientific target.

Our lead antibiotic candidate, ibezapolstat (formerly named ACX-362E), has a novel mechanism of action that targets the DNA pol IIIC enzyme, a previously unexploited scientific target.

Phase 2 clinical data validate the efficacy of our lead antibiotic candidate as well as pol IIIC as an appropriate bacterial target.

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No dose-dependent increase in adverse events, (each, an “AE”) was reported, and no serious AEs were observed.

The proportion of ibezapolstat-dosed subjects with an AE was similar to

placebo at each dosing level.

The proportion of ibezapolstat-dosed subjects with an AE was similar to placebo at each dosing level.

All AEs were considered mild or moderate and none required a change in therapy or intervention.

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We made this decision in consultation with our medical and scientific advisors and statisticians based on observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19 and its aftermath.

We determined that the

trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns.

We determined that the trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns.

Accordingly, an Independent Data Monitoring Committee was not required to perform an interim analysis of this Phase 2b trial data as originally planned.

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A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

Phase 2a results were published in CID (October 2022) and Phase 2b results were published in Lancet Microbe (June 2025).

We worked closely with the FDA to obtain authorization to proceed with clinical trials under our investigational new drug application (“IND”), and to obtain FDA fast track designation as well as designation of ibezapolstat as a qualified infectious disease product (“QIDP”), which provides incentives through the Generating Antibiotic Incentives Now Act (the “GAIN Act”) including FDA priority review for the first application submitted for the QIDP, fast track designation eligibility and extension of statutory exclusivity periods in the U.S.

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About QIDP and Fast Track Designations

The GAIN Act, which was enacted as part of the Food and Drug Administration Safety and Innovation Act (“FDASIA”) in 2012, created incentives for the development of novel antibiotic and antifungal products intended to treat

serious and life-threatening infections.

The GAIN Act amended the federal Food, Drug, and Cosmetic Act to add a designation for QIDPs.

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Pol IIIC-specific genes of several such Gram-positive bacteria have been cloned and expressed, and the DNA pol IIIC enzymes appear to share a unique capacity to be inhibited by 6-anilinouracils (“AU”), 2-phenylguanines (“PG”) and related compounds which are analogs of 2 ‘-deoxyguanosine 5’ -triphosphate (“dGTP”).

Explanation of the mechanism of action of DNA polC inhibitors was published in Nature Communications (October 2025).

The hypothesis supporting further development of ibezapolstat is that dGTP analog compounds bind to pol IIIC via a “base-pairing domain” and an enzyme-specific “aryl domain” ( Figure 1 ).

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Leiden University Medical Center/Health Holland Research Project

In August 2021, Health Holland awarded a grant of approximately $500,000 USD to Leiden University Medical Center (“LUMC”) to further study the mechanism of action of pol IIIC inhibitors in a consortium partnership with our

Company (the “Health Holland Research Project”).

This innovative research project entitled “Bad bugs, new drugs:

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Clinical Strategy

Based on advice from our medical and scientific consultants and advisors, we believe we will need to conduct one Phase 2 clinical trial prior to conducting one or two large Phase 3 clinical trials in order to file a new drug application

with the FDA for the oral use of ibezapolstat to treat patients with CDI.

The trial design and anticipated size of the required clinical trials is as follows:

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Such cure was sustained, meaning that the patients showed no sign of infection recurrence, for 30 days thereafter.

This constitutes a 100% response rate for the primary and secondary

endpoints of the trial.

This constitutes a 100% response rate for the primary and secondary endpoints of the trial.

All 10 patients enrolled in the Phase 2a trial met the study’s primary and secondary efficacy endpoints, namely, Clinical Cure at end of treatment and Sustained Clinical Cure of no recurrence of CDI at the 28-day follow-up visit.

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Emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C.

A decrease in primary bile acids and the favorable increase in the ratio of

secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

Phase 3 Clinical Trial(s).

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The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion.

In the case of some products for severe or life-threatening

diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

This phase involves studies in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

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The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.

also may inspect the sponsor and one or more clinical trial sites to assure compliance with GCP requirements and the integrity of the clinical data submitted to the FDA.

The FDA also may inspect the sponsor and one or more clinical trial sites to assure compliance with GCP requirements and the integrity of the clinical data submitted to the FDA.

The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality and purity.

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The 9kg batch was sufficient to support the Phase 1 and Phase 2 clinical trial needs.

No material issues were noted in the manufacture of either the 1 kg or 9 kg batches of ibezapolstat to date with 36-month stability very good and well within acceptable FDA standards.

Additionally, we can extrapolate to 48-months stability per FDA Manufacturing Guidance in advance of a 48-month pull point to occur in the first half of 2024.

No material issues were noted in the manufacture of either the 1 kg or 9 kg batches of ibezapolstat to date with 48-month stability and well within acceptable FDA standards.

Additionally, ibezapolstat drug substance is stable for at least four years and can be stored/transported in large quantities, allowing for strategic stockpiling.

Ibezapolstat drug product (“DP”), 150mg capsules, has been manufactured and used in the Phase 1 and Phase 2 clinical trials.

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Through our outside manufacturing vendors, we will continue to monitor the stability of DS and DP on an ongoing basis as we continue to advance the clinical development program.

We have received written positive feedback from FDA regarding acceptability of our Chemistry Manufacturing and Controls plan and data package proposed to support the Phase 3 clinical program.

We have received written positive feedback from FDA and the EMA regarding acceptability of our Chemistry Manufacturing and Controls plan and data package proposed to support the Phase 3 clinical program.

Commercial supply of RSMs (Regulatory Starting Materials), DS and DP will be made in the United States.

Market Opportunity

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difficile , especially drug-resistant strains, in the gut, allowing the continued growth of the bacteria.

This, together with a pronounced detrimental effect on the gut microbiome, leads to

recurrence in over 25% of CDI patients after therapy is stopped.

This, together with a pronounced detrimental effect on the gut microbiome, leads to recurrence in over 25% of CDI patients after therapy is stopped.

A significant unmet need remains for antibiotics that can meaningfully reduce recurrence.

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The peak market penetration of 40% assumes that there will be at least two treatment options available to treat CDI in addition to ibezapolstat even though only two antibiotics are currently recommended for the treatment of CDI and oral vancomycin has vulnerabilities with its 20%-40% reinfection rate and poor impact on patients’ microbiome.

The selling price estimate of $3,000 to $3,500 is considered by management to be conservative as it is well below the price point of fidaxomicin, the most-recent approval in treating CDI which we believe is between $4,500 and $5,000 for a full course of treatment.

Management believes that this market opportunity is substantial and provides significant upside potential for those investing at this early stage of development.

We believe the size of the market and relatively few treatment options available will drive our market capitalization and availability of financing alternatives as it completes Phase 2 clinical trials successfully.

Management believes that this market opportunity is substantial and provides significant upside potential for those investing at this stage of clinical development.

We believe the size of the market and relatively few treatment options available will drive our market capitalization and availability of financing alternatives having now completed Phase 2 clinical trials successfully, and is ready to proceed to Phase 3 clinical trials.

In addition, we believe ibezapolstat’s profile provides an opportunity to develop significant market penetration of patients with recurrent infection following use of one of the initial-episode treatment options because of its unique mechanism of action.

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Our competitors also may obtain marketing approvals for their products more rapidly than we obtain approval for ours.

In addition, our ability to compete in the marketplace may be affected because in some

cases insurers or other third-party payors seek to encourage the use of generic products.

In addition, our ability to compete in the marketplace may be affected because in some cases insurers or other third-party payors seek to encourage the use of generic products.

This may have the effect of making branded products less attractive, from a cost perspective, to buyers.

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Finch Therapeutics recently failed with CP101, its lead therapeutic targeting patients with multiple recurrences of CDI using donor derived stool samples in an oral formulation, to our understanding, and in January 2023 discontinued its Ph3 clinical trial in this area.

● Fecal biotherapy approaches in development include SER-109 (“VOWST”), which has now been FDA approved and marketed by Seres Therapeutics, Inc., is an oral microbiome therapeutic for the prevention of recurrent C.

● Fecal biotherapy approaches include SER-109 (“VOWST”), which has now been FDA approved and marketed by Nestle Health Sciences, having acquired global rights from Seres Therapeutics, is an oral microbiome therapeutic for the prevention of recurrent C.

difficile infection in adults with multiply recurrent CDI only after antibiotic therapy is administered.

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● CRS3123 (Crestone Inc) is a novel small molecule that selectively inhibits methionyl-tRNA synthetase of C.

difficile and is reported on clinicaltrials.gov as recruiting in a Phase 2 clinical trial with a primary completion date that was targeted for December 2021 but is listed as currently ongoing on the Crestone website.

On September 25, 2024, the Company announced it had completed a Phase 2 clinical trial but there are no indications publicly that Crestone has commenced Phase 3 trial.

● MGB-BP-3 (MGB Biopharma) is a novel synthetic polyamide active against Gram-positive pathogens and binds to the minor groove of DNA.

MGB announced that it has completed a dose-ranging Phase 2 clinical trial in 2020 but there are no indications publicly that MGB BioPharma has commenced Ph3.

● No new antibiotics in clinical development have shown improvement in either initial clinical cure (“ICR”) or sustained clinical response (“SCR”) in comparison to currently marketed antibiotics.

MGB announced that it has completed a dose-ranging Phase 2 clinical trial in 2020 but there are no indications publicly that MGB BioPharma has commenced Ph3 and it has been publicly reported that MGB went into liquidation in early 2025.

● No new antibiotics in Phase 3 ready stage of clinical development have shown improvement in either initial clinical cure (“ICR”) or sustained clinical response (“SCR”) in comparison to currently marketed antibiotics.

The data in the chart below constitute comparisons of data from prior clinical trials published in scientific journals for each listed antibiotic or antibiotic candidate and does not incorporate data, if any, from any control arm(s) that may be or may have been required to seek and obtain FDA approval.

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patents expire in September 2030, subject to extension under certain circumstances.

In 2024, we filed a Japanese patent application relating to ACX-375C, our second antibiotic program.

We also filed two U.S.

provisional patent applications relating to Acurx technology.

In 2025, we filed new Australian, Japanese, and U.S.

patent applications relating to ACX-375C, our second antibiotic program.

We also filed an international application and two provisional applications relating to Acurx technology.

We also filed a U.S.

application and foreign applications in Hong Kong, India, and Korea, which, along with our existing applications in that family, relate to methods of treating C.

difficile infection and preventing recurrence while simultaneously promoting microbiome health.

application and foreign applications in Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Korea, Mexico, New Zealand, and Singapore relating to methods and compositions for promoting microbiome health and for achieving and/or maintaining healthy proportions of gut microflora.

We believe the commercial opportunity for ibezapolstat is best protected by regulatory exclusivity in the U.S.

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We believe the patent and regulatory coverage already in place provides strong protection for the commercialization of ibezapolstat and we will continue to consider additional patent submissions as we review available pre-clinical and clinical data as it becomes available throughout the development program.

We have obtained three U.S.

patents and one Israeli patent on ACX-375C and have a fourth U.S.

We have obtained four U.S.

patents, one Australian patent, one Indian patent, one Israeli patent, and one Japanese patent on ACX-375C and have a fifth U.S.

patent application and multiple foreign applications pending for ACX-375C.

Our three U.S.

patents and Israeli patent on ACX-375C include composition-of-matter, surface coating, and method of use claims.

patents and four foreign patents on ACX-375C include composition-of-matter, surface coating, and method of use claims.

Absent any patent extensions, these patents will expire in December 2039.

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Absent any patent extensions, this patent will expire in June 2042.

We have an international application and two provisional applications related to additional antibiotic compounds.

We have a second U.S.

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difficile infection and preventing recurrence while simultaneously promoting microbiome health.

We have an international patent application relating to methods and compositions for promoting microbiome health and for achieving and/or maintaining healthy proportions of gut microflora.

We have a U.S.

patent application and several foreign applications relating to methods and compositions for promoting microbiome health and for achieving and/or maintaining healthy proportions of gut microflora.

We anticipate that the patent protection will be further supported by regulatory exclusivity available to new classes of antibiotics treating life-threatening infections (QIDP Designation by FDA – 5 years) and New Chemical Entity Designation (5 years).

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The initial hit ACX- 375C is pan-active against wild-type and drug-resistant Gram-positive bacteria (e.g., MRSA, VRE and PRSP).

We have synthesized and

tested >600 novel analogs targeting pol IIIC.

We have synthesized and tested >600 novel analogs targeting pol IIIC.

To date, 20 novel compounds with MIC values ≤1 μg/mL for both MRSA and VRE have been identified (see Table below).

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Recently, microbiological testing of certain ACX-375 DNA pol IIIC analogues in independent qualified laboratories, including the University of Florida, demonstrated in vitro activity with MICs of 0.5-2mcg/mL against B.

anthracis (Anthrax), a Bioterrorism Category A pathogen, including activity against ciprofloxacin resistant B.

anthracis (a nthrax), a Bioterrorism Category A pathogen, including activity against ciprofloxacin resistant B.

The initial in vitro activity shown against the Bioterrorism Category A pathogen B.

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The information contained on, or that can be accessed through, our website is not, and shall not be deemed to be part of, this Form 10-K.

On June 23, 2021, Acurx

Pharmaceuticals, LLC converted from a Delaware limited liability company into a Delaware corporation pursuant to a statutory conversion, and changed its name to Acurx Pharmaceuticals, Inc.

On June 23, 2021, Acurx Pharmaceuticals, LLC converted from a Delaware limited liability company into a Delaware corporation pursuant to a statutory conversion, and changed its name to Acurx Pharmaceuticals, Inc.

Available Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business