What changed in this filing

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Item 1. Business

2025-03-17 compared with 2024-03-15 · 88 added, 40 removed, 799 unchanged (14% of the section changed)

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Our research and development (“R&D”) pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile (“C.

difficile”), methicillin-resistant Staphylococcus aureus (“MRSA”), vancomycin resistant Enterococcus (“VRE”) and drug-resistant Streptococcus pneumoniae (“DRSP”).

difficile ”), methicillin-resistant Staphylococcus aureus (“MRSA”), vancomycin resistant Enterococcus (“VRE”) and drug-resistant Streptococcus pneumoniae (“DRSP”) and B.

anthracis (anthrax;

a Bioterrorism Category A Threat-Level pathogen).

These bacterial targets are listed as priority pathogens by the World Health Organization (“WHO”), the United States (“U.S.”) Centers for Disease Control and Prevention (“CDC”) and the U.S.

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The CDC estimates that, in the U.S., antibiotic-resistant pathogens infect one individual every 11 seconds and result in one death every 15 minutes.

The WHO recently stated that growing antimicrobial resistance is equally as dangerous as the recent COVID-19 pandemic, threatens to unwind a century of medical progress and may leave us defenseless against infections that today can be treated easily.

According to the WHO, the current clinical development pipeline remains insufficient to tackle the challenge of the increasing emergence and spread of antimicrobial resistance.

According to the WHO Fact Sheet (November 2023), Antimicrobial Resistance (AMR) is one of the top global public health and development threats.

It is estimated that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths.

Furthermore, the world faces an antibiotics pipeline and access crisis.

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.

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By blocking this enzyme, our antibiotic candidates are believed to be bactericidal and inhibit proliferation of several common Gram-positive bacterial pathogens, including both sensitive and resistant C.

difficile , MRSA, vancomycin-resistant Enterococcus, penicillin-resistant Streptococcus pneumonia (“PRSP”) and other resistant bacteria.

difficile , MRSA, vancomycin-resistant Enterococcus, penicillin-resistant Streptococcus pneumonia (“PRSP”) and other resistant bacteria and also including B.

anthracis (anthrax;

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.

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This pipeline includes ACX-375C, a potential oral and parenteral treatment targeting Gram-positive bacteria, including MRSA, VRE and PRSP.

We continue to evaluate a strategic transaction for the Company, including a partner for the further development and potential commercialization of our lead antibiotic candidate, ibezapolstat, as well as a potential sale, merger, third-party licensing arrangement or other strategic transaction.

We continue to evaluate potential strategic transactions for the Company, including a partner for the further development and potential commercialization of our lead antibiotic candidate, ibezapolstat, as well as a potential sale, merger, third-party licensing arrangement or other strategic transaction.

At this time we have no commitments from potential partners or others to provide the company with capital.

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These data were confirmed by the comparative microbiome data generated in the Phase 2b clinical trial and presented in a scientific poster on January 18, 2024 at the Gulf Coast Consortia Antimicrobial Resistance (AMR) Conference in Houston, Texas by Kevin Garey, PharmD, MS, Professor and Chair, University of Houston College of Pharmacy, the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program.

Additionally, ibezapolstat-treated patients showed decreased concentrations of fecal primary bile acids, and higher ratios of secondary to primary bile acids than vancomycin-treated patients.

These data were presented by Dr.

Kevin Garey as a scientific poster at the Infectious Diseases Society of America ( “IDSA”) IDWeek™ 2024 Conference held on October 16-19, 2024 in Los Angeles, CA and indicate a favorable gut bile acid profile which may contribute to ibezapolstat's beneficial anti-recurrence effect in patients with CDI.

Prior to conducting the Phase 2a clinical trial, we successfully completed a Phase 1 clinical trial of ibezapolstat for the oral treatment of CDI (the “Phase 1 Trial”).

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Kevin Garey at the University of Houston performed state-of-the-art microbiomic testing of gastrointestinal flora in trial subjects as compared with vancomycin, the standard of care for the treatment of patients with CDI, which testing was the first of its kind in Phase 1 clinical trials for CDI.

Data from the case report forms completed by the principal investigators of the Phase I trial showed that single and multiple ascending doses of ibezapolstat demonstrated a safety signal similar to placebo according to the principal investigators as evidenced by the case report forms.

Data from the case report forms completed by the principal investigators of the Phase I clinical trial showed that single and multiple ascending doses of ibezapolstat demonstrated a safety signal similar to placebo according to the principal investigators as evidenced by the case report forms.

There were no safety signals reported on the case report forms related to physical examination or vital signs (blood pressure, pulse or oral temperature) in any part of the study.

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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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Free concentrations of ibezapolstat were found to be high enough to kill C.

difficile but too low to kill healthy bacteria like Bacteroides &

Firmicutes which constitute approximately 90% of healthy microbiome in the judgment of our scientific advisors.

difficile but too low to kill healthy bacteria like Bacteroides & Firmicutes which constitute approximately 90% of healthy microbiome in the judgment of our scientific advisors.

Upon review of the final Phase 1 Trial data, our medical and scientific advisors suggested these data supported advancing ibezapolstat into a Phase 2 clinical trial at doses up to 450 mg, twice daily, for 10 days of treatment, as described above.

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Secondary objectives were to assess pharmacokinetic changes associated with food, determine systemic and fecal pharmacokinetics of ibezapolstat during both SAD and MAD administration, and to determine the fecal microbiome effects of ibezapolstat compared with oral vancomycin.

A total of 62 subjects were randomized to ibezapolstat or placebo.

Also in the Phase 1 clinical trial, a total of 62 subjects were randomized to ibezapolstat or placebo.

Ibezapolstat was administered at a dose of 150, 300, 600, 900 mg or placebo for 1 dose in the SAD part (6 active:2 placebo/ group), 300 mg for 1 dose in the food effect part (n=8), and 300 or 450 mg or placebo every 12 hours (6 active:2 placebo) or vancomycin 125 mg every 6 hours (n=6) for 10 days in the MAD part.

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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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The Phase 2b trial was originally designed to be a non-inferiority (“NI”) trial and later amended to include an interim efficacy analysis with review by an Independent Data Monitoring Committee (“IDMC”).

The decision to end the trial early based on blinded clinical observations obviated the need for an interim analysis, IDMC review, and NI

The decision to end the trial early based on blinded clinical observations obviated the need for an interim analysis, IDMC review, and NI assessment.

We determined, in consultation with our clinical and statistical experts, that presenting clinical cure rates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of ibezapolstat in treating CDI.

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We are also required to pay up to $700,000 in success-based clinical milestone payments to GLSynthesis, including a payment of $500,000 upon the successful completion of two phase 3 clinical trials and a royalty of 4% on net sales of ibezapolstat throughout the duration of the patent period, which currently extends to September 2030.

As of the date of this Form 10-K, of the $700,000 of potential milestone payments, we have paid to GLSynthesis a total of $50,000, including $25,000 paid upon receipt of a “safe to proceed” notification from FDA relating to the commencement of clinical trials (December 2018) and $25,000 paid upon the successful completion of clinical trial drug supply suitable to support our Phase 1 clinical trial (December 2018).

As of the date of this Form 10-K, of the $700,000 of potential milestone payments, we have paid to GLSynthesis a total of $200,000, including $25,000 paid upon receipt of a “safe to proceed” notification from FDA relating to the commencement of clinical trials (December 2018) and $25,000 paid upon the successful completion of clinical trial drug supply suitable to support our Phase 1 clinical trial (December 2018) and $150,000 paid upon the successful completion of the Phase 2 clinical trial.

The patent jurisdictions of the acquired patents include the U.S., European Union (“EU”), Japan and Canada.

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.

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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FDA’s fast track designation is a program designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need.

eligible for a Fast Track Designation, the FDA must determine, based on preclinical study data submitted by the sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need by providing a therapy where none exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors.

To be eligible for a Fast Track Designation, the FDA must determine, based on preclinical study data submitted by the sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need by providing a therapy where none exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors.

Fast track designation provides opportunities for more frequent interactions with the FDA review team to expedite development and review of the product.

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● Micronucleus assay:

● Embryo-Fetal Development:

Cardiovascular Safety:

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MTZ=metronidazole;

VAN=vancomyein;

VAN=vancomycin;

FDX=fidaxomicin.

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difficile bacteria as an urgent need for new antibiotics to treat CDI.

Fecal biotherapy aims to recolonize the bacteria that comprise the natural gut flora and, according to the 2017 IDSA Guidelines would be used for patients with multiple recurrences of CDI who have failed to resolve their infection despite treatment attempts with antibiotic agents targeting CDI.

Recently, two new fecal biotherapeutic products have been approved by FDA:

VOWST ™ (fecal microbiota spores, live-brpk), formerly SER 109, is marketed by Nestle Health Science and 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.

VOWST™ is expensive and under WARNINGS AND PRECAUTIONS in its product labelling lists that since VOWST™ is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents.

See “— Competition ” below.

Rebyota ® (fecal microbiota, live-jslm) is marketed by Ferring Pharmaceuticals, and is a fecal microbiota product which is prepared from stool donated by qualified individuals and delivered via enema for the prevention of recurrent Clostridioides difficile Infection (“rCDI”) in adults.

Rebyota® is also expensive and under WARNINGS AND PRECAUTIONS in its product labelling lists that since Rebyota® is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents.

See “ —Competition ” below.

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.

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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For the single-dose ascending portion of the trial, the objectives were to evaluate the safety and determine the pharmacokinetics and systemic exposure of single doses as well as the effects of food on PK.

The multiple ascending dose portion of the trial evaluated the safety, PK and fecal concentrations of repeated doses as well as evaluate the effects of ibezapolstat on characteristics of the gut microbiome in comparison to

the current standard of care treatment antibiotic, oral vancomycin.

We successfully completed the Phase 1 clinical trial in August 2019 and the data supported advancing to Phase 2 according to our medical and scientific advisors.

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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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We determined that the

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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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.

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).

Following completion of our Phase 2b clinical trial, we intend to meet with the FDA to finalize the size and scope of the Phase 3 clinical trial program.

Regulatory precedent indicates that two Phase 3 trials would need to be conducted.

Following completion of our Phase 2b clinical trial, and a successful End-of-Phase 2 meeting with FDA, we received formal regulatory guidance which allowed us to finalize the size and scope of the Phase 3 clinical trial program as well as agreement on requirements for NDA filing in the U.S.

We also received regulatory guidance from the European Medicines Agency confirming acceptability of our Phase 3 clinical trial protocol and the pathway forward to regulatory submission for marketing approval in the European Union if the Phase 3 clinical trial is successful.

We plan to include international clinical trial sites for our Phase 3 clinical trial program to enhance overall enrollment and provide clinical data to support an approval pathway outside the U.S.

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for an additional five years upon FDA approval of the product for the treatment of CDI.

We intend to launch regulatory activities in 2024 to design a regulatory approval pathway for ibezapolstat in the EU, the United Kingdom (“UK”), Canada and possibly Japan.

We commenced this international regulatory pathway by obtaining micro, small and medium-sized enterprises (“SME”) designation from the European Medicines Agency in February 2024.

We initiated regulatory activities in 2024 in Europe to design a regulatory approval pathway for ibezapolstat in the EU.

We will initiate similar regulatory activities in 2025 in Japan, the United Kingdom (“UK”) and Canada.

We have obtained small and medium-sized enterprises (“SME”) designation from the European Medicines Agency in February 2024.

The SME designation provides much reduced fees associated with the drug development pathway and close interaction with the regulatory authorities throughout the drug development process.

In addition, in December 2024, we received regulatory guidance from the European Medicines Agency confirming acceptability of our Phase 3 clinical trial protocol and the pathway forward to regulatory submission for approval if the Phase 3 clinical trial is successful.

Government Regulation

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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.

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.

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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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.

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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difficile bacteria and would be an adjunctive therapy to antibiotics.

Merck announced on December 23, 2024 that it would discontinue bezlotoximab on January 31, 2025.

No reason was cited for this discontinuation.

● Fecal biotherapy aims to recolonize the bacteria that comprise the natural gut flora and, according to the 2017 IDSA Guidelines would be used for patients with multiple recurrences of CDI who have failed to resolve their infection despite treatment attempts with antibiotic agents targeting CDI.

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

In addition, we have filed two provisional patent applications and an international patent application in 2023 covering methods and compositions for promoting microbiome health and for achieving and/or maintaining healthy proportions of gut microflora.

We also filed foreign applications in 2023 in Australia, Canada, China, Europe, Israel, Japan, Mexico, New Zealand and Singapore covering methods of treating C.

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.

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.

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8-years data exclusivity;

plus 2 additional years of marketing exclusivity plus 1 year for additional

indication (e.g., pediatric use);

plus 2 additional years of marketing exclusivity plus 1 year for additional indication (e.g., pediatric use);

8-years post-approval data exclusivity period for NCE;

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We have obtained three U.S.

patents and one Israeli patent on ACX-375C, our second antibiotic program, and have a fourth U.S.

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

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

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

Additionally, we have obtained a U.S.

patent on the use of ibezapolstat to promote microbiome health.

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

We have a second U.S.

patent application and multiple foreign patent applications pending relating to methods of treating C.

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 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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In addition, HHS would provide transitional support to fund Phase 3 clinical trials and manufacturing requirements for certain innovative antimicrobial drugs.

PROJECT BIOSHIELD.

This initiative currently resides in the fiscal year 2025 (“FY25”) Department of Homeland Security (“DHS”) (House Appropriations Committee Homeland Security) Subcommittee bill.

This language instructs DHS to proceed with an assessment / determination of AMR pathogens as a “material threat.” Once designated as a material threat (MTD), QIDP-designated antibiotics that are in Phase 3 or currently approved will automatically be eligible for Strategic National Stockpile (“SNS”) stockpiling through BARDA’s Project BioShield program.

Additionally, if the medical countermeasure (“MCM”) priority review voucher (“PRV”) is reauthorized, eligible companies with a novel active moiety would be eligible for a PRV, valued between $60.0 million - $120.0 million, upon approval.

AMR Action Fund .

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We have pioneered the clinical development of a pol IIIC inhibitor as a clinically valid bacterial target.

Ibezapolstat cured 10 of 10 (100%) patients after 10-days treatment with no recurrences during the 30-day follow up period in a Phase 2a trial for C.

difficile infection (CDI).

Ibezapolstat cured 10 of 10 (100%) patients after 10-days treatment with no recurrences during the 30-day follow up period in a Phase 2a trial for CDI.

Gut microbiome analyses further showed that potentially beneficial bacterial species are selectively preserved in CDI patients during treatment with ibezapolstat;

the pol IIIC Mechanism-of-Action (MOA) suggests that this is a class effect.

We are also developing a systemic pol IIIC Gram-positive selective spectrum (GPSS) oral and IV antibiotic.

We are also developing a systemic pol IIIC GPSS oral and IV antibiotic.

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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>2 to < 4 µg/mL

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.

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

anthracis (Anthrax) with some of our earlier-stage compounds included a ciprofloxacin-resistant strain.

Selective microbiome effects are planned to be tested with these new compounds as they proceed through development to treat infections caused by MRSA and other critical gram-positive pathogens in parallel with planning for the Anthrax bioterrorism program.

The Hit-to-Lead program produced improvements in solubility, cytotoxicity, and protein binding with a comprehensive SAR understanding.

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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