[gfp927z]

Acurx - Recent events include -


Ibeza Phase 2b results published in Lancet Microbe -

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176330178


$12 mil line of credit established -

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176271933


$2.67 mil proceeds from exercise of warrants (but a complicated transaction) -

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176338374


De-listing and reverse split saga -

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176271854


SEC filing - June 20, 2025 -- complicated warrants transaction(s) -

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001736243/000110465925060902/tm2518285d1_8k.htm



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[gfp927z]

>>> Acurx Pharmaceuticals, Inc. Announces Exercise of Warrants for $2.67 Million Gross Proceeds


PR Newswire

June 17, 2025


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-announces-exercise-014700584.html


STATEN ISLAND, N.Y., June 17, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it has entered into a warrant inducement agreement (the "Letter Agreement") with a certain holder ("Holder") of existing warrants to purchase up to an aggregate of 4,445,435 shares of common stock (the "Existing Warrants") having exercise prices ranging from $3.25 to $3.26 per share, issued by the Company in July 2022 and May 2023, wherein the Holder agreed to exercise the Existing Warrants at a reduced exercise price of $0.675 per share, resulting in gross proceeds of approximately $2.67 million, before deducting offering fees and other expenses payable by the Company. In consideration for the exercise of the Existing Warrants for cash, the investors received 6,223,609 G-1 warrants (the "G-1 Warrants") and 2,667,261 G-2 warrants (the "G-2 Warrants) to purchase up to an aggregate of 8,890,870 shares of common stock (the "New Warrants"). The G-1 Warrants are exercisable immediately at an exercise price of $0.425 per common share and will expire five years from the issuance date. The G-2 Warrants are exercisable upon shareholder approval at an exercise price of $0.425 per common share and will expire five years from the issuance date. The shares of common stock issuable upon exercise of the Existing Warrants are registered pursuant to effective resale registration statements on Form S-1 (File Nos. 333-267412 and 333-273015).

The transaction is expected to close no later than June 20, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the exercise for working capital and general corporate purposes.

The New Warrants are being issued in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such New Warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the New Warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate advancing to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillinresistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

<<<



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[glenn1919]

ACXP....................................https://stockcharts.com/h-sc/ui?s=ACXP&p=W&b=5&g=0&id=p86431144783

[gfp927z]

>>> Acurx Announces Publication in Lancet Microbe of Phase 2b Clinical Trial Data for Ibezapolstat in CDI


PR Newswire

June 17, 2025


https://finance.yahoo.com/news/acurx-announces-publication-lancet-microbe-110100523.html


As previously reported, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT

In contrast, 2 of 14 (14%) patients treated with the standard of care, oral vancomycin, experienced recurrent infection within one month after EOT

When Phase 2b results are combined with Phase 2a results, 25 of 25 (100%) ibezapolstat-treated patients with CDI who had CC at EOT remained recurrence-free through 1 month after EOT; additionally, all 5 Phase 2b ibezapolstat-treated patients observed for up to 3 months following CC experienced no recurrence of infection

Adding to this Lancet Microbe publication,two recent Journal of Antimicrobial Agents and Chemotherapeutics publications regarding, respectively, favorable gut microbiome effects which differentiate IBZ from other anti-CDI antibiotics and positive results from an in-silico study predicting the microbiome-restorative potential of IBZ

The totality of ibezapolstat data-to-date further advances Acurx's robust data package and are reshaping the therapeutic landscape for future treatment of CDI with ibezapolstat's innovative and potentially transformative new class of antibiotics to treat gram-positive infections while preserving and restoring the protective gut microbiota

Acurx is well positioned to begin international Phase 3 clinical trials and has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA


STATEN ISLAND, N.Y., June 17, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI). The Company today announced the publication of results in Lancet Microbe of its Phase 2b clinical study entitled: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study. The senior author is Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, and Principal Investigator for microbiology and microbiome aspects of the IBZ clinical trial program, and a co-author of the IDSA (Infectious Diseases Society of America) C. difficile Treatment Guidelines.

Professor Garey noted that current US and European treatment guidelines for CDI recommend only two antibiotics for treatment of CDI: oral vancomycin (VAN) or fidaxomicin (FDX). VAN is most commonly used with a low CC rate of 70-92% and an SCC rate of 42-71%. FDX has fewer recurrences but low rates of CC (84%) and SCC (67%); furthermore, both FDX and VAN are associated with emerging antimicrobial resistance. Dr. Garey also stated: "The clinical need for a new antibiotic, like IBZ, to treat CDI is underscored by a study recently published in Clinical Infectious Diseases conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding."

Acurx's Executive Chairman, Bob DeLuccia, stated: "This Lancet Microbe article complements the body of our published data to date, the totality of which establishes a comprehensive and formidable dossier to support our optimism for a successful Phase 3 clinical program and, if successful, first choice of IBZ as a front-line treatment for CDI. Our publications include data on IBZ chemistry, mechanism of action, microbiological activity, in vivo efficacy in the hamster model, human efficacy and safety, and favorable effects on the gut microbiome and bile acid metabolism." He further stated: "Data from our Phase 3 pivotal trials, if successful, will form the foundation for our continually evolving and attractive value proposition including in-market competitive advantage compared to vancomycin and fidaxomicin. Additionally, continuing optimization of our 'home-grown and made-in-America" supply chain will ensure scalability and reliability to be accessible and affordable worldwide".

This most recent publication adds important scientific information to supplement a growing list of peer-reviewed publications, including a Phase 1 study showing IBZ to be well-tolerated, localized to the gastrointestinal tract, and associated with preservation and restoration of beneficial gut microbiota. These Phase 2b study findings were supported by a Phase 2a, open-label, non-comparative study and showed 10 of 10 subjects were cured of CDI with no recurrence of infection. Based on this evidence, the Phase 2b study was initiated to assess the efficacy, safety, and associated microbiome changes of IBZ versus standard of care vancomycin (VAN).

This Phase 2b multi-site study was conducted at US medical clinics and hospitals. In the publication, Professor Garey summarized results which included high rates of CC in IBZ-treated subjects treated with no recurrence; furthermore, IBZ was found to be safe, well-tolerated, and associated with the preservation and restoration of key health-promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent CDI. The publication establishes that IBZ shows potential as a novel antibiotic treatment for CDI with high rates of CC and SCC while minimally disturbing the protective gut microbiota, thus further supporting its clinical development.

THE ABOVE-MENTIONED PUBLICATIONS ARE ON OUR WEBSITE: www.acurxpharma.com

Lancet Microbe: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study

Clinical Infectious Diseases: Emergence and Spread of Clostridioides difficile Isolates with Reduced Fidaxomicin Susceptibility in an Acute Care Hospital

About the Lancet Microbe

The Lancet Microbe is the world-leading microbiology research journal and publishes clinically relevant content on microbes at all scales, from the nature of the microbe (eg, antimicrobial resistance genes/plasmids, virulence factors) to the microbiome, to pathology (including immunology) to population level effects (eg, outbreaks, epidemiology). It also publishes early phase clinical trials and other interventional studies where the outcomes are focused on the pathogen. It is an internationally trusted source of clinical, public health, and global health knowledge.

About Clinical Infectious Diseases

Clinical Infectious Diseases (CID) is a leading journal in the field of infectious disease with a broad international readership. The Journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment. The Journal publishes original research (as Major Articles or Brief Reports), Review Articles, Viewpoints, Editorials, Invited Commentaries, Photo Quizzes, Practice Guidelines, Correspondence, and Supplements and is among the most highly cited journals in the field of infectious diseases. Clinical Infectious Diseases is an official publication of the Infectious Diseases Society of America.

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment (10 of 10).

In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. In this Phase 2b trial segment, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT.

When Phase 2b results are combined with Phase 2a results, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated patients) who had Clinical Cure at EOT) (End of Treatment) remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group. Ibezapolstat was well-tolerated, with no serious adverse events assessed by the blinded investigator to be drug- related. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation in both Clinical Cure and Sustained Clinical Cure.

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile infection. Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, 2015, NEJM). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, NEJM. Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (Garey, CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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[makinezmoney]

$ACXP: Pretty wicked pop here..... now $1

Wow............... nice way to start off the day.

Everyday something new shows up........ today its $ACXPs turn


GO $ACXP

[tw0122]

High end target $1.60-$1.80s float low enough 

[subslover]

Acurx Announces Publication in Lancet Microbe of Phase 2b Clinical Trial Data for Ibezapolstat in CDI
As previously reported, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT
In contrast, 2 of 14 (14%) patients treated with the standard of care, oral vancomycin, experienced recurrent infection within one month after EOT
When Phase 2b results are combined with Phase 2a results, 25 of 25 (100%) ibezapolstat-treated patients with CDI who had CC at EOT remained recurrence-free through 1 month after EOT; additionally, all 5 Phase 2b ibezapolstat-treated patients observed for up to 3 months following CC experienced no recurrence of infection
Adding to this Lancet Microbe publication, two recent Journal of Antimicrobial Agents and Chemotherapeutics publications regarding, respectively, favorable gut microbiome effects which differentiate IBZ from other anti-CDI antibiotics and positive results from an in-silico study predicting the microbiome-restorative potential of IBZ
The totality of ibezapolstat data-to-date further advances Acurx's robust data package and are reshaping the therapeutic landscape for future treatment of CDI with ibezapolstat's innovative and potentially transformative new class of antibiotics to treat gram-positive infections while preserving and restoring the protective gut microbiota
Acurx is well positioned to begin international Phase 3 clinical trials and has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA
STATEN ISLAND, N.Y., June 17, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI). The Company today announced the publication of results in Lancet Microbe of its Phase 2b clinical study entitled: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study. The senior author is Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, and Principal Investigator for microbiology and microbiome aspects of the IBZ clinical trial program, and a co-author of the IDSA (Infectious Diseases Society of America) C. difficile Treatment Guidelines.

Professor Garey noted that current US and European treatment guidelines for CDI recommend only two antibiotics for treatment of CDI: oral vancomycin (VAN) or fidaxomicin (FDX). VAN is most commonly used with a low CC rate of 70-92% and an SCC rate of 42-71%. FDX has fewer recurrences but low rates of CC (84%) and SCC (67%); furthermore, both FDX and VAN are associated with emerging antimicrobial resistance. Dr. Garey also stated: "The clinical need for a new antibiotic, like IBZ, to treat CDI is underscored by a study recently published in Clinical Infectious Diseases conducted in a hospital setting, documenting that C. difficile isolates with clinically relevant reduced fidaxomicin susceptibility may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding."

Acurx's Executive Chairman, Bob DeLuccia, stated: "This Lancet Microbe article complements the body of our published data to date, the totality of which establishes a comprehensive and formidable dossier to support our optimism for a successful Phase 3 clinical program and, if successful, first choice of IBZ as a front-line treatment for CDI. Our publications include data on IBZ chemistry, mechanism of action, microbiological activity, in vivo efficacy in the hamster model, human efficacy and safety, and favorable effects on the gut microbiome and bile acid metabolism." He further stated: "Data from our Phase 3 pivotal trials, if successful, will form the foundation for our continually evolving and attractive value proposition including in-market competitive advantage compared to vancomycin and fidaxomicin. Additionally, continuing optimization of our 'home-grown and made-in-America" supply chain will ensure scalability and reliability to be accessible and affordable worldwide".

This most recent publication adds important scientific information to supplement a growing list of peer-reviewed publications, including a Phase 1 study showing IBZ to be well-tolerated, localized to the gastrointestinal tract, and associated with preservation and restoration of beneficial gut microbiota. These Phase 2b study findings were supported by a Phase 2a, open-label, non-comparative study and showed 10 of 10 subjects were cured of CDI with no recurrence of infection. Based on this evidence, the Phase 2b study was initiated to assess the efficacy, safety, and associated microbiome changes of IBZ versus standard of care vancomycin (VAN).

This Phase 2b multi-site study was conducted at US medical clinics and hospitals. In the publication, Professor Garey summarized results which included high rates of CC in IBZ-treated subjects treated with no recurrence; furthermore, IBZ was found to be safe, well-tolerated, and associated with the preservation and restoration of key health-promoting bacteria responsible for bile acid homeostasis, a key component in preventing recurrent CDI. The publication establishes that IBZ shows potential as a novel antibiotic treatment for CDI with high rates of CC and SCC while minimally disturbing the protective gut microbiota, thus further supporting its clinical development.

THE ABOVE-MENTIONED PUBLICATIONS ARE ON OUR WEBSITE: www.acurxpharma.com

Lancet Microbe: Efficacy, safety, pharmacokinetics, and associated microbiome changes of ibezapolstat compared with vancomycin in adults with Clostridioides difficile infection: a phase 2b, randomized, double-blind, active-controlled, multicenter study
Clinical Infectious Diseases: Emergence and Spread of Clostridioides difficile Isolates with Reduced Fidaxomicin Susceptibility in an Acute Care Hospital

About the Lancet Microbe
The Lancet Microbe is the world-leading microbiology research journal and publishes clinically relevant content on microbes at all scales, from the nature of the microbe (eg, antimicrobial resistance genes/plasmids, virulence factors) to the microbiome, to pathology (including immunology) to population level effects (eg, outbreaks, epidemiology). It also publishes early phase clinical trials and other interventional studies where the outcomes are focused on the pathogen. It is an internationally trusted source of clinical, public health, and global health knowledge.

About Clinical Infectious Diseases
Clinical Infectious Diseases (CID) is a leading journal in the field of infectious disease with a broad international readership. The Journal publishes articles on a variety of subjects of interest to practitioners and researchers. Topics range from clinical descriptions of infections, public health, microbiology, and immunology to the prevention of infection, the evaluation of current and novel treatments, and the promotion of optimal practices for diagnosis and treatment. The Journal publishes original research (as Major Articles or Brief Reports), Review Articles, Viewpoints, Editorials, Invited Commentaries, Photo Quizzes, Practice Guidelines, Correspondence, and Supplements and is among the most highly cited journals in the field of infectious diseases. Clinical Infectious Diseases is an official publication of the Infectious Diseases Society of America.

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if t

[gfp927z]

I see Acurx now has a new $12 mil equity line of credit, so that should help buy time until full funding can be found for the Phase 3, a partnership deal occurs, or M+A could be another possibility -


>>> In May 2025, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding. <<<


________________________


>>> Acurx Pharmaceuticals, Inc. Reports First Quarter Results and Provides Business Update


PR Newswire

May 13, 2025


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-reports-first-110100835.html


STATEN ISLAND, N.Y., May 13, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the first quarter ended March 31, 2025.

Highlights of the first quarter ended March 31, 2025, or in some cases shortly thereafter, include:

In January 2025, the Company announced it had closed a $2.5 million registered direct offering priced at the market under Nasdaq rules.

Also in January 2025, we announced that we received positive regulatory guidance from the European Medicines Agency (EMA) for the ibezapolstat (IBZ) Phase 3 clinical trial program, which is aligned with FDA on matters of manufacturing, non-clinical and clinical aspects of the Phase 3 program. The EMA guidance also confirmed ibezapolstat's regulatory pathway for a Marketing Authorization Application to be filed by the Company after successful completion of the Phase 3 clinical trials. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

In February 2025 and in March 2025, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important non-clinical studies which we believe we can leverage to show further positive differentiation for competitive advantage of IBZ vs all other antibiotics used for the first line therapy of C. difficile infection. And, given our clinical results to date, we're hopeful that this anti-recurrence effect of IBZ could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI.

In February 2025, we announced positive results from this first study, conducted by Dr. Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Diseases (or NIAID). It was an in-silico study that predicted the microbiome-restorative potential of IBZ for treating CDI. Our scientific advisors consider this to be a major finding which provides a mechanistic explanation for IBZ's selectivity in that the predicted bactericidal interaction between IBZ and its target, the DNA pol IIIC enzyme, allows regrowth of gut microbes known to confer health benefits.

In March 2025, we announced the second study, conducted by Dr. Trenton Wolfe, from the University of Montana, which was funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), and the Company. This study is the first ever head-to-head comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VAN)-or metronidazole (MET)-treated groups, complementing prior Phase 2 clinical findings showing IBZ's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of IBZ- and the fidaxomicin (FDX)-treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies.These results establish IBZ's differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader-spectrum antibiotics like VAN and MET and a narrower spectrum of microbiome alteration compared to FDX.

Also in February 2025, the Japanese Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX-375C, our pre-clinical antibiotic candidate targeting the treatment of MRSA, VRE and Anthrax infections.

In March 2025, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million.

In April 2025, the Indian Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing development of ACX-375.

In May 2025, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding.

First Quarter 2025 Financial Results

Cash Position:

The Company ended the quarter with cash totaling $4.6 million, compared to $3.7 million as of December 31, 2024. The Company raised a total of approximately $3.6 million of gross proceeds thru two Registered Direct Offerings.

R&D Expenses:

Research and development expenses for the three months ended March 31, 2025 were $0.6 million compared to $1.6 million for the three months ended March 31, 2024, a decrease of $1.0 million. The decrease was due primarily to a decrease in manufacturing costs of $0.4 million, and a decrease in consulting costs of $0.6 million as a result of the prior year trial related expenses.

G&A Expenses:

General and administrative expenses for the three months ended March 31, 2025 were $1.6 million compared to $2.8 million for the three months ended March 31, 2024, a decrease of $1.2 million. The decrease was primarily due to $0.7 million decrease in professional fees resulting from lower consulting expenses, and a $0.6 million decrease in share-based compensation costs.

Net Income/Loss:

The Company reported a net loss of $2.1 million or $0.11 per diluted share for the three months ended March 31, 2025 compared to a net loss of $4.4 million or $0.28 per diluted share for the three months ended March 31, 2024, for the reasons previously mentioned.

The Company had 22,397,511 shares outstanding as of March 31, 2025.

Conference Call

As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:

Tuesday, May 13, 2025

Time:

8:00 a.m. ET

Toll free (U.S.):

1-877-790-1503; Conference ID: 13753625

International:

Click here for participant international Toll-Free access numbers

https://www.incommconferencing.com/international-dial-in

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate advancing to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillinresistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.

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It looks like Acurx is planning for a reverse split (link below). They have a deadline of August 25 to get the share price over $1 to avoid delisting, but there might be some additional time available to comply. Anyway, the ability to reverse split was on the recent SHM voting ballot -


Reverse split - https://www.sec.gov/Archives/edgar/data/1736243/000110465925054244/tm252476d5_defa14a.htm

Delisting - https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175873278



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>>> Acurx Pharmaceuticals, Inc. Reports First Quarter Results and Provides Business Update


PR Newswire

May 13, 2025


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-reports-first-110100835.html


STATEN ISLAND, N.Y., May 13, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the first quarter ended March 31, 2025.

Highlights of the first quarter ended March 31, 2025, or in some cases shortly thereafter, include:

In January 2025, the Company announced it had closed a $2.5 million registered direct offering priced at the market under Nasdaq rules.

Also in January 2025, we announced that we received positive regulatory guidance from the European Medicines Agency (EMA) for the ibezapolstat (IBZ) Phase 3 clinical trial program, which is aligned with FDA on matters of manufacturing, non-clinical and clinical aspects of the Phase 3 program. The EMA guidance also confirmed ibezapolstat's regulatory pathway for a Marketing Authorization Application to be filed by the Company after successful completion of the Phase 3 clinical trials. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

In February 2025 and in March 2025, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important non-clinical studies which we believe we can leverage to show further positive differentiation for competitive advantage of IBZ vs all other antibiotics used for the first line therapy of C. difficile infection. And, given our clinical results to date, we're hopeful that this anti-recurrence effect of IBZ could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI.

In February 2025, we announced positive results from this first study, conducted by Dr. Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Diseases (or NIAID). It was an in-silico study that predicted the microbiome-restorative potential of IBZ for treating CDI. Our scientific advisors consider this to be a major finding which provides a mechanistic explanation for IBZ's selectivity in that the predicted bactericidal interaction between IBZ and its target, the DNA pol IIIC enzyme, allows regrowth of gut microbes known to confer health benefits.

In March 2025, we announced the second study, conducted by Dr. Trenton Wolfe, from the University of Montana, which was funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), and the Company. This study is the first ever head-to-head comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VAN)-or metronidazole (MET)-treated groups, complementing prior Phase 2 clinical findings showing IBZ's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of IBZ- and the fidaxomicin (FDX)-treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies.These results establish IBZ's differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader-spectrum antibiotics like VAN and MET and a narrower spectrum of microbiome alteration compared to FDX.

Also in February 2025, the Japanese Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX-375C, our pre-clinical antibiotic candidate targeting the treatment of MRSA, VRE and Anthrax infections.

In March 2025, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million.

In April 2025, the Indian Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes another significant building block for our ongoing development of ACX-375.

In May 2025, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding.

First Quarter 2025 Financial Results

Cash Position:

The Company ended the quarter with cash totaling $4.6 million, compared to $3.7 million as of December 31, 2024. The Company raised a total of approximately $3.6 million of gross proceeds thru two Registered Direct Offerings.

R&D Expenses:

Research and development expenses for the three months ended March 31, 2025 were $0.6 million compared to $1.6 million for the three months ended March 31, 2024, a decrease of $1.0 million. The decrease was due primarily to a decrease in manufacturing costs of $0.4 million, and a decrease in consulting costs of $0.6 million as a result of the prior year trial related expenses.

G&A Expenses:

General and administrative expenses for the three months ended March 31, 2025 were $1.6 million compared to $2.8 million for the three months ended March 31, 2024, a decrease of $1.2 million. The decrease was primarily due to $0.7 million decrease in professional fees resulting from lower consulting expenses, and a $0.6 million decrease in share-based compensation costs.

Net Income/Loss:

The Company reported a net loss of $2.1 million or $0.11 per diluted share for the three months ended March 31, 2025 compared to a net loss of $4.4 million or $0.28 per diluted share for the three months ended March 31, 2024, for the reasons previously mentioned.

The Company had 22,397,511 shares outstanding as of March 31, 2025.

Conference Call

As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:

Tuesday, May 13, 2025

Time:

8:00 a.m. ET

Toll free (U.S.):

1-877-790-1503; Conference ID: 13753625

International:

Click here for participant international Toll-Free access numbers

https://www.incommconferencing.com/international-dial-in

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate advancing to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillinresistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.

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Acurx infomercial -

But where's the pharma partnership to run the Phase 3?

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[Monksdream]

ACXP, new 52 week low

[gfp927z]

The boneheaded Bitcoin move in November led to the unraveling. It cut the stock in half, forced the desperation financing in Jan, and threw a wrench into ongoing partnering negotiations. Now the 'circling the drain' stage begins..


>>> Acurx Board of Directors Approves Bitcoin as Treasury Reserve Asset

PR Newswire

November 20, 2024

https://finance.yahoo.com/news/acurx-board-directors-approves-bitcoin-120100338.html

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https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175416746



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From bad to worse for Acurx -


>>> Acurx Pharmaceuticals, Inc. Announces $1.1 Million Registered Direct Offering


PR Newswire

March 7, 2025


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-announces-1-130000100.html


STATEN ISLAND, N.Y., March 7, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,745,000 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $0.40 per share (or per common stock equivalent in lieu thereof) in a registered direct offering. In addition, in a concurrent private placement, the Company will issue unregistered short-term warrants to purchase up to 8,235,000 shares of common stock. The warrants will have an exercise price of $0.40 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the warrants (the "Stockholder Approval") and will expire twenty-four months following the date of Stockholder Approval. The closing of the offering is expected to occur on or about March 10, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $1.1 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-265956) filed with the Securities and Exchange Commission ("SEC") on July 1, 2022, and became effective on July 11, 2022. The registered direct offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC and be available at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at [phone] or e-mail at [e-mail].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials this year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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>>> Acurx Pharmaceuticals to Discuss Fourth Quarter and Full Year 2024 Financial Results on March 18, 2025 Conference Call and Provide Business Update


PR Newswire

February 28, 2025


https://finance.yahoo.com/news/acurx-pharmaceuticals-discuss-fourth-quarter-130000228.html


STATEN ISLAND, N.Y., Feb. 28, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its fourth quarter and full year 2024 financial results on Tuesday, March 18, 2025 at 8:00 am ET before the U.S. financial markets open.

David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:

Tuesday, March 18, 2025

Time:

8:00 a.m. ET

Toll free (U.S.):

1-877-790-1503;

Conference ID:

13752142

International:

Click here for participant international Toll-Free access numbers

https://www.incommconferencing.com/international-dial-in

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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Acurx - >>> Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On February 24, 2025, Acurx Pharmaceuticals, Inc. (the “Company”) received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying the Company that for the preceding 31 consecutive business days the Company’s common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The notice has no immediate effect on the listing or trading of the Company’s common stock, and the common stock will continue to trade on The Nasdaq Capital Market under the symbol “ACXP” at this time.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until August 25, 2025, to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance can be achieved automatically and without further action if the closing bid price of the Company’s common stock is at or above $1.00 for a minimum of 10 consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company of its compliance and the matter will be closed.

If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by August 25, 2025, the Company may be eligible for additional time to comply. In order to be eligible for such additional time, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and must notify Nasdaq in writing of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to Nasdaq that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel.

The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the Minimum Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or that Nasdaq will grant the Company a further extension of time to regain compliance, if applicable.


https://www.sec.gov/ix?doc=/Archives/edgar/data/0001736243/000110465925017437/tm257571d1_8k.htm


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>>> Acurx Announces Publication of Positive Results from an In-Silico Study Predicting the Microbiome-Restorative Potential of Ibezapolstat in the Treatment of CDI


PR Newswire

February 24, 2025


https://finance.yahoo.com/news/acurx-announces-publication-positive-results-130000199.html


Major finding provides mechanistic explanation for ibezapolstat's (IBZ) selectivity in that the predicted bactericidal interaction between IBZ and its target DNA pol IIIC is conserved across most of the Bacillota phylum, including C. difficile, while certain beneficial taxa are naturally resistant to IBZ, allowing regrowth of resistant microbes known to confer health benefits

This study used in silico methods to better interpret the narrower than expected ibezapolstat (IBZ) spectrum of activity observed in human trials, which included increased proportion of certain key gut microbiota of the Bacillota phylum

IBZ susceptibility of human commensal (nonpathogenic) microbiota was predicted using genomic analysis and a phylogenetic tree construction of the IBZ target enzyme, pol IIIC

Preparation continues to advance IBZ into international Ph3 clinical trials for treatment of CDI

IBZ has previously been granted FDA QIDP and Fast-Track Designation and has received SME (Small and Medium-sized Enterprise) designation by the EMA


STATEN ISLAND, N.Y., Feb. 24, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat (IBZ), preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced the results of a study and its publication in the Journal of Antimicrobial Agents and Chemotherapeutics entitled: "The Microbiome-restorative Potential of Ibezapolstat for the Treatment of Clostridioides difficile Infection is Predicted Through Variant PolC-type DNA Polymerase III in Lachnospiraceae and Oscillospiraceae". The primary researcher and author is Jacob K. McPherson, PharmD, a PhD Pharmacology Candidate at the University of Houston. This study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

According to co-author Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program, and Acurx Scientific Advisory Board member: "These studies help to explain the narrower than expected spectrum of activity of ibezapolstat in our ongoing clinical trials that helps explain regrowth of beneficial gut microbiota while patients are on ibezapolstat therapy." He added: "Genomic differences in the PolC between these species affect the binding of ibezapolstat allowing these beneficial microbes to be resistant and confer health benefits. This is distinctly different that the comparator vancomycin which kills these beneficial microbes causing high rates of C. difficile recurrence."

Acurx's Executive Chairman, Bob DeLuccia, stated: "This in silico genomic analysis complements the structural biology data emerging from our scientific collaboration with Leiden University Medical Center." He further stated: "We're confident that these results can be leveraged to advance not only the ibezapolstat program but also our systemic Gram-positive antibiotic discovery program in lead optimization for an oral pol IIIC inhibitor for methicillin-resistant Staphylococcus aureus (MRSA) and in parallel planning for our anti-anthrax bioterrorism program."

During clinical trials with IBZ, a narrower than expected spectrum of activity was observed that included increased proportion of certain key microbiota of the Bacillota phylum known to confer health benefits, specifically Lachnospiraceae, Oscillospiraceae (formerly Ruminococcaceae), and Coprobacillaceae within Erysipelotrichales. The purpose of this study was to utilize in silico approaches to better interpret the narrower than expected IBZ spectrum of activity observed in human trials. IBZ susceptibility to human commensal microbiota was predicted using genomic analysis and PolC phylogenetic tree construction in relation to C. difficile and commensal low G + C bacteria. An amino acid phylogenetic tree identified certain residues that were phylogenetically variant in Lachnospiraceae, Oscillospiraceae, and Erysipelotrichales but conserved in C. difficile. The major finding of this study was that the predicted interactions between IBZ and pol IIIC is conserved across the majority of the Bacillota phylum except for Lachnospiraceae and Oscillospiraceae, and Erysipelotrichales (including Erysipelotrichaceae and Coprobacillaceae), taxa that were not killed or regrown in IBZ-treated subjects while on therapy.

THE PUBLICATION IS ON OUR WEBSITE: www.acurxpharma.com

About the AAC Journal:

Antimicrobial Agents and Chemotherapy (AAC) is an interdisciplinary journal devoted to the dissemination of knowledge relating to all aspects of antimicrobial and antiparasitic agents and chemotherapy. Generally, any report involving studies on or with antimicrobial, antiviral (including antiretroviral), or antiparasitic agents is within the purview of AAC. Studies involving animal models, pharmacological characterization, and clinical trials are appropriate for consideration.

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (Link to Clinicaltrials.gov/NCT042447542) This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment).

In the Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind.

The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment.

There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI)

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015,

New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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[StarryChimera74]

news on the BTC reverse ?

[gfp927z]

>>> JPO Grants Acurx Pharmaceuticals Patent in Japan for DNA Polymerase IIIC Inhibitors


PR Newswire

February 19, 2025


https://finance.yahoo.com/news/jpo-grants-acurx-pharmaceuticals-patent-130000150.html


STATEN ISLAND, N.Y., Feb. 19, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that a new patent has been granted by the Japanese Patent Office (JPO) in January 2025. This patent relates to DNA Polymerase IIIC Inhibitors, including compositions-of-matter, surface coatings and pharmaceutical compositions for use in methods of treating Gram-positive bacterial infection. This is the latest in the series of granted patents and pending patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials. To date, Acurx has obtained three U.S. patents, one Israeli patent and now one Japanese patent, in each case, which cover the ACX-375C program, relating to DNA Polymerase IIIC Inhibitors, with other country-level filings in process.

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "Complementing our global patent estate with minimally absorbed oral ibezapolstat, now Phase 3-ready for the treatment and prevention of recurrence of C. difficile Infection, this patent, with others to follow, is very important and timely as we further develop our innovative, AI-supported drug discovery platform of second-generation DNA pol IIIC inhibitors. He added: "Other compounds in our program are systemically absorbed for potential oral and parenteral use in multiple clinical settings for treatment of infections caused by other gram-positive bacteria, such as Staphylococcus aureus, including MRSA and B. anthracis or anthrax; a Bioterrorism Category A Threat-Level pathogen."

Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a marketing authorization application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned Phase 3 international, 1:1 randomized clinical trials (designed as non-inferiority trials vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program.

The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (Link to Clinicaltrials.gov/NCT042447542) This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment).

In the Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind.

The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI)

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015,

New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being the maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes the development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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[glenn1919]

ACXP........................https://stockcharts.com/h-sc/ui?s=ACXP&p=W&b=5&g=0&id=p86431144783

[gfp927z]

Yes, it looks like Luci and other management did put up some of their own money in the direct offering. Only for 167,488 shares total, plus some warrants, but I guess it demonstrates having some 'skin in the game'. Now if they would only reverse that loony Bitcoin announcement, lol..


https://www.sec.gov/Archives/edgar/data/1736243/000110465925001589/tm252141d1_424b5.htm

>>> We are offering an aggregate of 2,463,058 shares of our common stock, par value $0.001 per share (“common stock”) consisting of (i) an aggregate of 2,295,570 shares of common stock purchased by certain institutional investors (the “institutional investors”) and (ii) an aggregate of 167,488 shares of common stock purchased by David P. Luci, our President and Chief Executive Officer, Robert J. DeLuccia, our Executive Chairman, Carl V. Sailer, Jack H. Dean, James Donohue, and Joseph Scodari, each members of our Board of Directors (the “affiliate investors”). The offering price of each share of common stock is $1.015. In a concurrent private placement, we are also selling to such investors, series E warrants to purchase up to an aggregate of 2,463,058 shares of our common stock (the “warrants”). The warrants will have an exercise price of $0.90 per share, will be exercisable immediately upon issuance and will expire five years from the initial exercise date. The warrants and the shares of common stock issuable upon the exercise of the warrants are not being registered under the Securities Act of 1933, as amended (the “Securities Act”), are not being offered pursuant to this prospectus supplement and the accompanying prospectus and are being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.

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[gfp927z]

More info on the registered offering -

(Note - it sounds like Luci and other Acurx management are participating in the offering, and putting up their own personal money in exchange for shares and warrants(?) Not sure, but that's what it sounds like in the 8-K) -


>>> On January 6, 2025, Acurx Pharmaceuticals, Inc., a Delaware corporation (the “Company”), entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional investors named therein (the “Investors”), and with each of David P. Luci, our President and Chief Executive Officer, Robert J. DeLuccia, our Executive Chairman, Carl V. Sailer, Jack H. Dean, James Donohue, and Joseph Scodari, each a member of our board of directors (collectively, the “Affiliate Investors”), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the Investors and to the Affiliate Investors (the “Registered Offering”), an aggregate of 2,463,058 shares (the “Shares”) of common stock, par value $0.001 per share, of the Company (the “Common Stock”) (consisting of an aggregate of 2,295,570 Shares purchased by the Investors and an aggregate of 167,488 Shares purchased by the Affiliate Investors), at an offering price of $1.015 per share, for aggregate gross proceeds from the Registered Offering of approximately $2.5 million, before deducting the placement agent fees and related offering expenses. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

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https://www.sec.gov/ix?doc=/Archives/edgar/data/0001736243/000110465925001586/tm252142d1_8k.htm


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[gfp927z]

Acurx --> The ATM financing approach has been suspended (see below), and instead they went with a registered direct offering (with warrants) instead. Interesting development -


https://www.sec.gov/Archives/edgar/data/1736243/000110465925001282/tm252097d1_424b3.htm


>>> The Prospectus relates to the sale of shares of our common stock, par value $0.001 per share (the “common stock”), in an “at-the-market” offering (the “ATM Program”) pursuant to the at the sales agreement, dated November 15, 2023 (the “Sales Agreement”). In accordance with the terms of the Sales Agreement, we may offer and sell from time-to-time shares of our common stock through A.G.P./Alliance Global Partners, acting as our sales agent. As of the date hereof, we have sold 2,830,328 shares of common stock under the Sales Agreement, raising net proceeds of approximately $8.8 million. The terms “Company,” “we,” “us” and “our” refer to Acurx Pharmaceuticals, Inc., a Delaware corporation.

We are filing this Prospectus Supplement to amend the Prospectus to reduce the amount of shares registered under the Prospectus to $0.00 and to suspend the ATM Program. As a result, we may not make any sales of our common stock pursuant to the Sales Agreement unless and until a new prospectus supplement is filed with the Securities and Exchange Commission; however the Sales Agreement remains in full force and effect...

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>>> Acurx Pharmaceuticals, Inc. Announces $2.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules


PR Newswire

January 6, 2025


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-announces-2-223500421.html


STATEN ISLAND, N.Y., Jan. 6, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,463,058 shares of its common stock at a purchase price of $1.015 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 2,463,058 shares of common stock. The warrants will have an exercise price of $0.90 per share, will be exercisable upon issuance and expire five years following the date of issuance. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $2.5 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The shares of common stock (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-265956) filed with the Securities and Exchange Commission ("SEC") on July 1, 2022 and became effective on July 11, 2022. The registered direct offering of the shares of common stock is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered in the registered direct offering will be filed with the SEC and be available at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at [phone] or e-mail at [e-mail].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials this year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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[glenn1919]

ACXP............................................a/h

[gfp927z]

>>> Acurx Receives Positive Regulatory Guidance from EMA for Ibezapolstat Phase 3 Program for C. Difficile Infection (CDI)


PR Newswire

January 6, 2025


https://finance.yahoo.com/news/acurx-receives-positive-regulatory-guidance-133000707.html


Acurx has now received positive written responses from the EMA (European Medicines Agency) under its Scientific Advice Procedure that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted supports advancement of the ibezapolstat Phase 3 program

The responses also included guidance on ibezapolstat's regulatory pathway for a Marketing Authorization Application for ibezapolstat in CDI

With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program

Acurx is also preparing to request regulatory guidance to initiate clinical trials in Japan, Canada and the United Kingdom

Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designation from FDA and Acurx has received SME (Small and Medium-sized Enterprise) designation by the EMA to benefit from fee incentives and other support from the EMA for EU Marketing Authorization


STATEN ISLAND, N.Y., Jan. 6, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced that it has received positive regulatory guidance from the EMA during its Scientific Advice Procedure that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted supports advancement of the ibezapolstat Phase 3 program. The information package supporting the Phase 3 program included details on Acurx's two planned Phase 3 clinical trials (designed as non-inferiority trials vs vancomycin), the patient population, primary endpoint of Clinical Cure, sample size, statistical analysis plan and the overall registration safety database.

Acurx's Executive Chairman, Bob DeLuccia, stated: "We are appreciative of the EMA's constructive suggestions, and we will proactively incorporate them into our global registration plan. He further stated: "We are very pleased with the latest favorable communications from both regulatory agencies which provide a straightforward international roadmap for conduct of our Phase 3 program and ultimate requirements for a US NDA (New Drug Application) submission and EU Marketing Authorization Application."

Written communications are used by both regulatory agencies in lieu of face-to-face or teleconference/video conferences when these agencies determine that a written response to the sponsor's questions would be the most appropriate means for providing feedback and advice to the sponsor. (FDA Guidance on Formal Meetings, EMA Guidance on Centralised Procedure)

Acurx previously announced it had a successful End of Phase 2 Meeting achieving agreement with FDA on non-clinical and clinical Phase 3-readiness, including written positive feedback regarding acceptability of its CMC (Chemistry Manufacturing and Controls) plan and data package proposed to support the Phase 3 clinical program. In addition, Acurx had initiated the Scientific Advice procedure with the EMA to discuss the readiness for initiation of the Phase 3 clinical program in the EU. Acurx is preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada.

Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (Link to Clinicaltrials.gov/NCT042447542) This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment).

In the Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment.

There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI)

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015,

New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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[XenaLives]

Interesting tech - It is common knowledge that most "antiobiotics" assault the microbiome, making long term recovery impossible.

[gfp927z]

>>> Acurx Updates Phase 3 Readiness for Ibezapolstat in C. difficile Infection Based on Recent FDA and EMA Communications


PR Newswire

December 9, 2024


https://finance.yahoo.com/news/acurx-updates-phase-3-readiness-130000907.html


Following the previously announced successful End of Phase 2 Meeting achieving agreement with FDA on non-clinical and clinical Phase 3-readiness, Acurx has now also received written positive feedback from FDA regarding acceptability of our CMC (Chemistry Manufacturing and Controls) plan and data package proposed to support the Phase 3 clinical program

Acurx has initiated the Scientific Advice procedure with the European Medicines Agency (EMA) to discuss the readiness for initiation of the Phase 3 clinical program in the European Union (EU). Acurx has been notified that we should expect to receive the final written advice letter in the coming few weeks

Acurx is also in the process of discussing the pediatric development plans for ibezapolstat in C. difficile Infection with FDA and EU health authorities, per regulatory requirements.

Phase 3 international trial planning continues to advance, using AI and other state-of-the-art techniques to identify and qualify clinical trial sites with the highest potential for patient enrollment

Acurx is also preparing to request regulatory guidance to initiate clinical trials in Japan, Canada and the United Kingdom

Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designation from FDA and Acurx has received SME (Small and Medium-sized Enterprise) designation by the EMA to benefit from fee incentives and other support from the EMA for EU Marketing Authorization


STATEN ISLAND, N.Y., Dec. 9, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). The Company today announced updates on Phase 3 Readiness for Ibezapolstat in C. difficile Infection based on recent FDA and EMA Communications.

Written communications are used by both regulatory agencies in lieu of face-to-face or teleconference/video conferences when these agencies determine that a written response to the sponsor's questions would be the most appropriate means for providing feedback and advice to the sponsor. (FDA Guidance on Formal Meetings, EMA Guidance on Centralised Procedure)

Acurx's Executive Chairman, Bob DeLuccia, stated: "We are very pleased with these latest favorable communications from both regulatory agencies and in our opinion are a testament to the strength of our clinical data to date, our robust regulatory submissions, and adherence to current regulatory guidance." He further added: "We anticipate, and are confident, that with final EMA advice for our ibezapolstat Phase 3 trials for adult patients with CDI and the pediatric development plans from both regulatory agencies, Acurx will have a clear international roadmap for conduct of our Phase 3 program and, if successful, requirements for US NDA submission and EU Marketing Authorization."

Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI). Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada.

Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-reat (mITT) population consistent with EMA requirements. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (Link to Clinicaltrials.gov/NCT042447542) This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment).

In the Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug- related. All three events were gastrointestinal in nature and resolved without treatment.

There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI)

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi: 0.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug-resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

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[gfp927z]

Acurx - >>> MicroStrategy Copycats Are Buying Bitcoin as Price Nears $100,000


Barron's

by Paul R. La Monica

Nov 22, 2024


https://www.barrons.com/articles/microstrategy-copycats-companies-buy-bitcoin-0032c5ff?siteid=yhoof2


As Bitcoin heads toward $100,000, it looks like three tiny biotechs are hoping to emulate the success of MicroStrategy, the software company whose stock has gone into orbit as it plows money into the cryptocurrency.

In just the past week, Acurx Pharmaceuticals, Hoth Therapeutics, and Enlivex Therapeutics have announced plans to invest up to $1 million each in Bitcoin. That is, of course, an infinitesimal amount compared with MicroStrategy, whose balance-sheet holdings of 331,200 coins are now worth about $32.8 billion, one-third of its more than $95 billion market capitalization.

MicroStrategy stock is up nearly 600% so far this year.

The three biotech companies all said in news releases that they were taking the crypto plunge due to increased support for Bitcoin among institutional investors. They suggested that Bitcoin could be a good hedge against inflation.

“As demand for Bitcoin grows, and so does its acceptance as a major and primary asset class, we believe that Bitcoin will serve as a strong treasury reserve asset for cash not needed over the next 12 to 18 months” said David Luci, president and CEO of Acurx, in a press release, echoing similar statements made by Enlivex CEO Oren Hershkovitz and Hoth CEO Robb Knie.

It is true that big money-management firms, such as BlackRock, Fidelity, Invesco, and Cathie Wood’s ARK Invest have all jumped into the Bitcoin pool with crypto exchange-traded funds. But whether Bitcoin actually is the new “digital gold” and can hold its value during times of dollar weakness and rising inflation over the long haul remains to be seen.

Regardless of where Bitcoin heads next, investors shouldn’t expect any of these penny stock biotechs to take off. For one, they are all early-stage microcap companies that are thinly traded, volatile, and unprofitable.

Acurx, worth about $20 million, is the largest of the trio. To say that they were already risky investments before they announced plans to buy Bitcoin is an understatement.

Investors seem to realize that none of them are the next MicroStrategy. Only Hoth’s shares got a modest pop this week, rising about 6% following its Bitcoin announcement. And all three stocks are down sharply this year, with Hoth tumbling 40% and Enlivex and Acurx each plunging more than 65%.

Still, it will be worth watching to see whether other larger and more recognizable publicly traded companies decide to buy and hold Bitcoin for their corporate treasuries.

Besides MicroStrategy, only a handful of other companies have Bitcoin on their balance sheets. Many of them are in the crypto sector, such as Coinbase; Block, owner of Square and Cash App; and Bitcoin miners MARA Holdings, Hut 8, and Riot Platforms. Elon Musk’s Tesla is also a Bitcoin investor.

But who knows? Though the price is surging now, with a gain of almost 50% in the past four weeks, this could wind up being a short-term speculative top for Bitcoin. It is a little reminiscent of late 2017, when Bitcoin surged to nearly $20,000, and non-crypto companies flocked to the business.

A company named Long Island Iced Tea Corp., which made a nonalcoholic version of the popular beverage, changed its name to Long Blockchain. It was delisted in 2021. Penny stocks Rich Cigars and e-cigarette maker Vapetek also announced plans to become blockchain firms.

Bitcoin tumbled to below $4,000 by December 2018 and took about two years to recover to its 2017 levels. This doesn’t mean history will repeat itself and that Bitcoin will plunge precipitously.

But investors should remember that any time there is a speculative mania like the one occurring now, more volatility, at the very least, is highly likely.

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[gfp927z]

Beyond stupid - >>> Acurx Board of Directors Approves Bitcoin as Treasury Reserve Asset


PR Newswire

November 20, 2024


https://finance.yahoo.com/news/acurx-board-directors-approves-bitcoin-120100338.html


STATEN ISLAND, N.Y., Nov. 20, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company's Board of Directors approved the purchase of up to $1 million in Bitcoin to hold as a treasury reserve asset.

"As demand for Bitcoin grows, and so does its acceptance as a major and primary asset class, we believe that Bitcoin will serve as a strong treasury reserve asset for cash not needed over the next 12 to 18 months" said David P. Luci, President & CEO of Acurx. "With the recent approval of Bitcoin ETFs and the growing support from government agencies and institutional investors, it is a great addition to our treasury strategy. Its limited supply and inflation-resistant characteristics provide a functional store of value. This new treasury strategy is a finance strategy and has no impact on our overarching drug development plans."

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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[paulie c]

WTF....what an assclown move...BTC at all time high and these clowns buy it? LMFAO. so that million could be 500k by time they need it....hard to believe a BOD would approve such a transaction

[willlbone]

Buying Bitcoin was dumb, sell.

[gfp927z]

>>> Acurx Announces Additional Ibezapolstat Ph2b Results in CDI as well as Anthrax (B. anthracis) Susceptibility to ACX-375 Analogues


PR Newswire

September 26, 2024


https://finance.yahoo.com/news/acurx-announces-additional-ibezapolstat-ph2b-110000237.html


New analyses extend data on beneficial effects of ibezapolstat on the gut microbiome

Confirmed ibezapolstat's favorable pharmacokinetics showing low systemic exposure and high colonic concentrations

Selected ACX-375 analogues demonstrated in vitro activity against Anthrax (B. anthracis), a Bioterrorism Category A pathogen, including activity against ciprofloxacin resistant Anthrax. Planning is underway for an Anthrax bioterrorism development program

Preparation continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)

Preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada

Ibezapolstat has previously received FDA QIDP and Fast-Track Designation from FDA


STATEN ISLAND, N.Y., Sept. 26, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced results from new analyses that extend data on the beneficial effects of ibezapolstat on the gut microbiome. The data show an increased proportion of Actinobacteriota and increased quantity of beneficial Bacillota (Firmicutes) leading to reversal of dysbiosis and contributing to the CDI anti-recurrence effect of ibezapolstat.

Additionally, ibezapolstat's favorable pharmacokinetics properties were confirmed showing mean systemic exposure below 1mcg/mL and fecal concentrations well in excess of the minimal inhibitory concentration (MIC) for C. difficile.

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.

The above results were presented at the premier International C. difficile Symposium (ICDS) held in Bled, Slovenia on September 17-19, 2024. Kevin Garey, PharmD, MS, FIDSA, Professor and Chair, University of Houston College of Pharmacy, Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program, and Acurx Scientific Advisory Board member delivered a presentation entitled: Ibezapolstat Preserves Key Clostridium leptum Species. Microbiome Results from the Phase 2, Randomized, Double-blind Study of ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides Difficile Infection.

According to Dr. Garey: "The microbiome data also show an unexpected finding of a unique microbiome signature in two vancomycin-treated patients in the Ph2b trial who experienced recurrence of CDI. Since these changes were evident and observed early during treatment and then consistently until the end of therapy, they may be predictive of pending CDI recurrence and suggest the need to modify therapy."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "These new data add to and reinforce ibezapolstat's emerging overall distinctive product profile, particularly the favorable microbiome-related unexpected findings." He added: "Furthermore, 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 will be tested with these new compounds as they proceed through development to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other critical gram-positive pathogens in parallel with planning for the Anthrax bioterrorism program. The presentation is available on the Acurx Pharmaceuticals website www.acurxpharma.com

Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI). Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada.

Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population consistent with EMA requirements. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

About the C. difficile Symposium (ICDS)

The International C. difficile Symposium (ICDS) is now established as the premier venue for the review of Clostridium difficile research.

The 1st meeting was held in Kranjska Gora in 2004, the 2nd in Maribor in 2007, while all earlier meetings were in Bled in 2010, 2012, 2015 and in 2018. ICDS in 2020 was held virtually. The 2024 meeting will provide the ideal opportunity to review progress in epidemiology, diagnostics, clinical trials, basic research and in understanding C. difficile pathogenesis and controlling the devastating disease it causes.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment).

In the now completed Phase 2b trial segment, which was discontinued due to success, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment.

There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

In the Phase 2 clinical trial, the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI)

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com

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>>> Acurx Pharmaceuticals, Inc. Reports Second Quarter 2024 Results and Provides Business Update


PR Newswire

Aug 9, 2024


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-reports-second-110100900.html


STATEN ISLAND, N.Y., Aug. 9, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the second quarter ended June 30, 2024.

Highlights of the second quarter ended June 30, 2024, or in some cases shortly thereafter, include:

In April 2024, we completed a successful End-of-Phase 2 Clinical Meeting with FDA and confirmed Phase 3 Readiness for ibezapolstat (IBZ) to enter Phase 3 clinical trials for the treatment of C. difficile infection. Agreement with FDA was reached on key elements to move forward with our international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. We've since continued activities to advance IBZ into international Phase 3 clinical trials for treatment of C. difficile Infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada.

Also in April 2024, we attended the European Society of Microbiology and Infectious Disease (or ESCMID) scientific congress. Dr. Kevin Garey provided an oral presentation of our Phase 2 data entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of C. difficile Infection." Dr. Garey is Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for microbiology and microbiome aspects of the IBZ clinical trial program and Acurx Scientific Advisory Board member. The oral presentation included additional analyses of clinical and microbiological data and is available on our website at www.acurxpharma.com. The complete Phase 2 results are being prepared for submission to a prominent scientific journal for publication. The oral presentation is available on our website at www.acurxpharma.com.

In May 2024, we announced that the European Medicines Agency (or EMA) approved our application to be designated as a small to medium sized enterprise (or SME) in Europe which provides for certain benefits including fee reductions and other support from the EMA for seeking a Marketing Authorization for Europe.

In July 2024, results from the IBZ Phase 2 clinical trial in patients with C. difficile Infection were presented at the 17th Biennial Congress of the Anaerobe Society of the Americas by Taryn A. Eubank, PharmD, BCIDP, Research Assistant Professor, University of Houston College of Pharmacy delivered an oral presentation entitled: "Clinical Efficacy of Ibezapolstat in CDI: Results from Phase 2 trials."

Also in July 2024, and very timely given our late-stage development progress, the USPTO (United States Patent and Trademark Office) granted Acurx a new patent for IBZ which specifically encompasses the "treatment of C. difficile infection while reducing recurrence of infection and improving the health of the gut microbiome. This patent expires in June 2042 and we think will provide an important downstream competitive advantage.

In August 2024, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product and packaging (a "CMC Meeting) in order to commence Phase 3 clinical trials. This FDA submission is customary and follows our successful End of Ph2 clinical meeting with FDA which confirmed our Ph3 clinical trial readiness. We anticipate convening a meeting with FDA regarding CMC in the fourth quarter.

Throughout the rest of this year, we'll continue to roll out our Phase 2 results in either oral presentations or scientific posters (in some cases both), which will include results from new analyses as data become available, at various prominent scientific conferences including:

In September 2024, the World Antimicrobial Resistance conference in Philadelphia;

In September 2024, the 8th International C. difficile Symposium (or ICDS meeting) in Bled, Slovania, which is the premiere global venue for the review of C. difficile research; and

In October 2024, we will be presenting at the annual meeting of the Infectious Diseases Society of America (or ID Week) in Los Angeles.

International Regulatory Initiatives will continue in 2H 2024.

Second Quarter of 2024 Financial Results

Cash Position:

The Company ended the quarter with cash totaling $6.4 million, compared to $7.5 million as of December 31, 2023. During the second quarter, the Company sold an additional 133,066 shares under its ATM financing program, with gross proceeds of approximately $0.3 million.

R&D Expenses:

Research and development expenses for the three months ended June 30, 2024 were $1.8 million compared to $1.7 million for the three months ended June 30, 2023. The increase was due primarily to an increase in manufacturing related costs during the quarter of $0.4 million, partially offset by a reduction in consulting fees of $0.3 million. For the six months ended June 30, 2024 research & development expenses were $3.4 million compared to $2.8 million for the six months ended June 30, 2023, an increase of $0.6 million primarily due to $0.8 million increase in manufacturing related costs offset by $0.2 million decrease in consulting fees.

G&A Expenses:

General and administrative expenses for the three months ended June 30, 2024 were $2.3 million compared to $1.7 million for the three months ended June 30, 2023, an increase of $0.6 million. The increase was primarily due to $0.3 million increase in professional fees and $0.2 million increase in non cash share-based compensation related costs. For the six months ended June 30, 2024, general and administrative expenses were $5.1 million compared to $3.6 million for the six months ended June 30, 2023, an increase of $1.5 million. The increase was primarily due to $1.0 million increase in professional fees, $0.4 million increase in non cash share-based compensation costs and $0.1 million increase in legal costs

Net Income/Loss:

The Company reported a net loss of $4.1 million or $0.26 per diluted share for the three months ended June 30, 2024 compared to a net loss of $3.4 million or $0.28 per diluted share for the three months ended June 30, 2023, and a net loss of $8.5 million or $0.54 per share for the six months ended June 30, 2024, compared to a net loss of $6.3 million or $0.53 per share for the reasons previously mentioned.

The Company had 15,996,168 shares outstanding as of June 30, 2024.

Conference Call

As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

Date:

Friday, August 9, 2024

Time:

8:00 a.m. ET

Toll free (U.S. and International):

877-790-1503

Conference ID:

13747936

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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>>> USPTO Grants Acurx Pharmaceuticals New Patent for Ibezapolstat to Treat CDI While Reducing Recurrence of Infection and Improving Health of the Gut Microbiome


PR Newswire

Jul 17, 2024


https://finance.yahoo.com/news/uspto-grants-acurx-pharmaceuticals-patent-110000920.html


STATEN ISLAND, N.Y., July 17, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that a new patent has been granted by the United States Patent and Trademark Office (USPTO) on July 16, 2024. This patent relates to ibezapolstat and its use to treat C. difficile Infection (CDI) while reducing the recurrence of the infection, as well as improving the health of the gut microbiome. This is the latest in the series of granted patents and pending patent applications that Acrux has filed to protect its proprietary technologies in the field of antimicrobials.

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "This patent is very important and timely as ibezapolstat continues to demonstrate previously unexpected and favorable effects on the gut microbiome while at the same time curing the C. difficile bacterial infection and preventing recurrent infection." He further added: "As we continue to prepare for initiation of our Phase 3 clinical program, we expect this feature of ibezapolstat's selective mechanism of action to be further demonstrated and to be an important competitive advantage over currently available antibiotics by reducing the recurrence of the infection. This could have a dramatically favorable effect on patient outcomes and on reducing downstream healthcare costs."

David P. Luci, President & CEO of Acurx stated: "This latest patent is part of our company's pivotal product, ibezapolstat, which is a two-dimensional antibiotic to cure infections clinically comparable to marketed antibiotics while restoring the microbiome and preventing reinfections which is unusually positive for CDI antibiotics."

Acurx has previously announced that it had a successful FDA End-of- Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application (NDA) for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI). Acurx is also now preparing to submit requests for guidance to initiate clinical trials in the European Union, the United Kingdom, Japan and Canada.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 2a trial, including the treatment-related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population consistent with EMA requirements. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment. The Company's Scientific Advisory Board concurred with this recommendation.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The Company previously reported that the overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment.

There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October 2022).

The Phase 2b clinical trial segment was discontinued due to success. The Company made this decision in consultation with its 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. The Company had 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.

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 assessment. The Company determined, in consultation with its 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.

In the Phase 2 clinical trial, the Company will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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. The company also recently reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 12 patients who agreed to be followed up to three months following Clinical Cure of their infection, 5 of 5 IBZ patients experienced no recurrence of infection. In the vancomycin control arm of the trial, 7 of 7 patients experienced no recurrence of infection. ECC success is defined as a clinical cure at the TOC visit (i.e., at least 48 hours post EOT) and no recurrence of CDI within the 56 ± 2 days post EOT (ECC56) and 84 ± 2 days post EOT (ECC84) in patients who consented to extended observation. In the Phase 2b trial, 100% (5 of 5) of ibezapolstat-treated patients who agreed to observation for up to three months following Clinical Cure of CDI experienced no recurrence of infection.

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI).

According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of healthcare-associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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[gfp927z]

Acurx - CEO Luci interview -

The odds appear good for a partnership deal fairly soon, I'm figuring between now and the end of the year. Should be interesting -

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[TRADER99]

Tipranks has analyst price targets of $10/$11/$12 on ACXP

[FALCON1]

https://www.zacks.com/stock/news/2300964/the-zacks-analyst-blog-highlights-danaher-morgan-stanley-pfizer-elite-pharmaceuticals-and-oil-dri

https://www.zacks.com/stock/news/2300922/zacks-initiates-coverage-of-elite-pharmaceuticals-with-outperform-recommendation

[Monksdream]

ACXP under $3

[TRADER99]

The WhatsApp groups are pumping this from $2.80 this a.m.

[gfp927z]

>>> Q1 2024 Acurx Pharmaceuticals Inc Earnings Call


Thomson Reuters

May 15, 2024


https://finance.yahoo.com/news/q1-2024-acurx-pharmaceuticals-inc-024052823.html


Participants

David P. Luci; Co-Founder, President, CEO, Corporate Secretary & Director; Acurx Pharmaceuticals, Inc.

Robert G. Shawah; Co-Founder & CFO; Acurx Pharmaceuticals, Inc.

Robert J. DeLuccia; Co-Founder & Executive Chairman; Acurx Pharmaceuticals, Inc.

Antonio Eduardo Arce; MD of Equity Research & Senior Healthcare Analyst; H.C. Wainwright & Co, LLC, Research Division

James Francis Molloy; MD of Equity Research and Biotechnology & Specialty Pharmaceuticals Equity Research Analyst; Alliance Global Partners, Research Division

Unidentified Participant

Presentation
Operator

Hello, and welcome to the Acurx Pharmaceuticals First Quarter 2024 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to CFO, Robert Shawah. Please go ahead.

Robert G. Shawah

Thank you, Kevin. Good morning, and welcome to our call. This morning we issued a press release providing financial results and company highlights for the first quarter of 2024, which is available on our website at acurxpharma.com. Joining me today is Dave Luci, President and CEO of Acurx, who will give a corporate update and outlook; as well as our Executive Chairman, Bob DeLuccia. After that, I'll provide some highlights of the financials from the quarter ended March 31, 2024, then turn the call back over to Dave and Bob for their closing remarks.

As a reminder, during today's call, we'll be making certain forward-looking statements. These forward-looking statements are based on current information, assumptions, estimates and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. Investors should consider these risks and other information described in our filings made with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed on Tuesday, May 14, 2024.

You're cautioned not to place undue reliance on these forward-looking statements, and Acurx disclaims any obligation to update such statements anytime in the future. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast today, May 15, 2024.

I'll now turn the call over to Dave Luci. Dave?

David P. Luci

Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the first quarter and also to hear some exciting recent updates. Then we'd be pleased to take any questions. First, I'll summarize some of our key activities for the first quarter of 2024, or in some cases, shortly thereafter. In January, we announced positive comparative microbiology and microbiome data for ibezapolstat, our lead antibiotic candidate in C. diff patients from the Phase IIb clinical trial segment.

Ibezapolstat outperformed vancomycin, a standard of care, showing eradication of fecal C. difficile at day 3 of treatment in 15 of 16 treated patients, 94%, versus vancomycin, which had eradication of C. difficile in 10 of 14 treated patients or 71%. Additional data from the Phase IIb clinical trial showed ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacteria species believed to confer health benefits, including preventing recurrent C. diff infection.

Additional data from exploratory endpoints will provide further favorable separation between these 2 therapeutic options in our Phase III clinical trial program and ultimately in the marketplace, if approved. We remain particularly excited about the dual impact of ibezapolstat to treat acute C. difficile on the one hand, while appropriately managing the long-term care of each patient's microbiome, which we believe is truly exceptional for antibiotic therapy.

Having robust preclinical, clinical and manufacturing data to date, we submitted, in January, a formidable information package to the FDA, along with a request for an end of Phase II meeting, which was granted on February 26, and the meeting was convened on April 17. At the FDA meeting, we reached agreement on key elements of our Phase III program. including, importantly, agreement with the FDA regarding readiness to proceed to Phase III, as well as agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. We will press release further details on the FDA meeting premarket this morning.

In February, we announced that the European Medicines Agency approved our application to be designated as a small to medium-sized enterprise or SME in Europe, which provides for certain benefits, including fee reductions and other support from the agency for seeking a marketing authorization in Europe. We attended the European Society of Microbiology and Infectious Disease or ESCMID Scientific Congress in April 2024, where Dr. Kevin Garey, Professor and Chair, University of Houston, College of Pharmacy, and the Principal Investigator for Microbiology and Microbiome aspects of our clinical trial program, and our Scientific Advisory Board member, provided an oral presentation of Phase II data entitled, "A Phase II Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of C. difficile Infection". The presentation included additional analyses of clinical and microbiological data and is available on our website at www.acurxpharma.com. The complete Phase II results are being prepared for submission to a prominent scientific journal for publication this year.

Throughout the rest of this year, we'll continue to roll out our Phase II results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data become available at various prominent scientific conferences, including the Houston C. diff & Microbiome Conference later this month, the Anaerobe Society of the Americas Annual Conference in July, the World Antimicrobial Resistance Conference in September. Also in September is the International C. diff Symposium, and of course, the Annual Meeting of the Infectious Disease Society of America, or ID Week, in October.

Throughout the first quarter, we continued preparations for Phase III trials, including advances in micro and manufacturing, CRO selection and clinical site screening, and building a team of international drug development experts to support our Phase III mandate. To ensure Phase III clinical trial enrollment as quickly as possible, we're adding substantially more clinical trial sites, way above the number used to conduct the U.S.-only Phase II trials.

We're now finalizing costs and time lines and our plan is to conduct the required 2 Phase III registration trials consecutively, not concurrently, given the size of our company, and need to use our financial resources most efficiently. The time line to conduct our Phase III trials is not a concern since ibezapolstat will have a rolling 10 years of regulatory exclusivity in the U.S. from the date of the FDA approval, with similar exclusivity available in Europe, the U.K., Japan, and Canada.

We will continue to seek a strategic transaction for the company, including a potential partnership for the further development and potential commercialization of ibezapolstat, alongside preparation for Phase III and our build-out strategy. At this time, we have no commitments to our potential partners or others to report. But now having FDA confirmation of the registration plan, this has become an active initiative.

As we've consistently reported, ibezapolstat clinical results continue to outperform in a series of potentially life-threatening infection. The CDC categorizes C. difficile as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Ibezapolstat is also FDA fast track designated for the treatment of C. difficile infection.
Initially, we believe ibezapolstat, if approved, could make a favorable impact by reducing the cost burden of recurrent C. diff infection on the U.S. health care system, which is estimated at $4.7 billion annually. We do believe the best is yet to come.

And now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the first quarter. Rob?

Robert G. Shawah

Thanks, Dave. Our financial results for the first quarter ended March 31, 2024, were included in our press release issued earlier this morning. The company ended the quarter with cash totaling $8.9 million compared to $7.5 million as of December 31, 2023. During the first quarter, the company sold an additional 1,121,793 shares under its ATM financing program with gross proceeds of approximately $4.4 million.

Research and development expenses for the 3 months ended March 31, 2024, were $1.6 million compared to $1 million for the 3 months ended March 31, 2023. The increase was due primarily to an increase in manufacturing-related costs during the quarter. General and administrative expenses for the 3 months ended March 31, 2024, were $2.8 million compared to $1.9 million for the 3 months ended March 31, 2023. The increase was due primarily to a $0.7 million increase in professional fees and a $0.2 million increase in noncash share-based compensation.

The company reported a net loss of $4.4 million or $0.28 per diluted share for the 3 months ended March 31, 2024, compared to a net loss of $2.9 million or $0.25 per diluted share for the 3 months ended March 31, 2023, all for the reasons we previously mentioned. The company had 15,757,102 shares outstanding as of March 31, 2024.

With that, I'll turn the call back over to Dave. Dave?

David P. Luci

Thanks, Rob, and thanks to all of you for joining us today. I'll now ask Bob DeLuccia, our Executive Chairman, who managed the FDA post-Phase II meeting process, to provide his perspective on the FDA meeting in the company's Phase III mandate. Bob?

Robert J. DeLuccia

Yes. Thanks, Dave. So let me just add a few thoughts on top of Dave's comments about our end of Phase II meeting with the FDA. In general, it was a very thorough, productive, and successful meeting regarding 4 things.

First, we had overall agreement that was reached based upon the strength of our preclinical and Phase II clinical trial results, including the anticipated safety database, we're ready to move forward with plans for our Phase III program.

Second, with respect to the Phase III clinical trial design, as expected, it will be the same design as our Phase IIb trial, which is noninferiority to vancomycin, with the primary endpoint being clinical cure after 10 days of treatment, and a secondary endpoint of sustained clinical cure about 30 days after the end of treatment.

Third, we agreed on the statistical analysis patient population, which will be a modified intent to treat or what's called MITT population, with an estimated 450 subjects in that MITT group. And this is roughly what we had expected and will now be in sync with requirements for an EMA clinical trial authorization.

And lastly, agreement on the registration program for 2 noninferiority trials versus vancomycin, which would be required for marketing approval. Now I'd also add that we were very pleased with suggestions from the FDA, including ultimate labeling and overall supportive tone of the FDA from our submitted data to date and our plan going forward. So bottom line, we now have a complete regulatory road map to move forward with our Phase III program, which is the last clinical development step toward marketing registration of ibezapolstat globally. For a small entrepreneurial company like Acurx, this is a very significant milestone that we've reached.

And Dave, if you don't mind, I'd like to add one more thing just on top of what you said. Recall that ibezapolstat has FDA fast track designated status due to the urgent need classification by the U.S. CDC for new classes of antibiotics. And there are similar classifications like this available in other geographies, including Europe, the U.K., Japan and Canada. If approved, ibezapolstat will be the first new class of antibiotics brought to the market in over 3 decades. So we've got no time to waste to get this new product over the goal line. And with the continued support of all our shareholders, we have a clear vision and a strong passion to be successful for the ultimate benefit of patients who need better treatment for C. difficile infection and all our stakeholders and, in general, for better public health. Kevin?

Question and Answer Session
Operator

(Operator Instructions) Our first question today is coming from Ed Arce from H.C. Wainwright.

Antonio Eduardo Arce

Bob, I appreciate the comments at the end. Those were some of the questions I had regarding the specifics around the trial. A couple of follow-ups there. Firstly, the 450 patients or subjects that you mentioned, is that the total number for the trial? And also, the usual requirement from the FDA of 2 well-designed pivotal studies. I want to just confirm that the Phase Ib is being considered as one of those 2. And so this upcoming trial would be the final study?

Secondly, I wanted to ask about the costs and time lines. I know that you said that those are currently being finalized. But any preliminary or early commentary around those would be helpful for us. And then lastly, around the strategic partners and your efforts now that you characterized as being active, now that you have a pathway for a pivotal study. I'm wondering, although you don't have any current commitments, do you have any active discussions at this point? Thanks so much.

David P. Luci

Thank you for your questions, Ed. The last question being the easiest, I'll hit that 1 first. So we have several active discussions at the moment. Nothing to report. But for example, the company will be well represented at the BIO CEO conference in San Diego, and my schedule is chock full. So there's a lot of activity. We felt it most appropriate, before making outbound calls, to have the FDA piece to the puzzle in place, because we now are truly Phase III ready and that removes another piece of the puzzle in terms of things being set in stone. So that's all set.

On the first question, with regard to the 450 MITT patients, that's the total MITT patients for each of 2 Phase III registration trials. So the Phase IIb is not considered a registration trial. You may recall the small numbers of patients. And quite frankly, we needed a lot more patients to have satisfactory safety database for an NDA application thereafter. So it's 450 patients MITT for each of 2 trials, for a total of 900.

And to your question, we are still going through the cost things. So we don't know exactly how much it will cost. And in some cases, if we have a partnership, it may be that some of the work that we would have paid for would be internalized by a fully integrated pharma company that will be side-by-side with us with mutual interest to get the Phase III program done as quickly as possible, and using our Phase III data for filing in Europe, the U.K., Japan. So the MITT piece to the puzzle was a quick conversation with the FDA, because really, you need that to get to file for approval in Europe and the U.K. So by agreeing on that particular point, we were able to avoid further clinical trials beyond the 2 Phase IIIs. And quite literally, we have an equal pathway in the U.S., the U.K. and Europe. So we're kind of delighted with that piece to the puzzle. But I think that's -- is there another piece to your question that I may have missed?

Robert J. DeLuccia

Yes, Dave. Question on time line. I mean I can answer if you'd like to?

David P. Luci

Okay. Time line. Yes, we feel, based on what we spent out so far that would be 1.5 years to 2 years from first patient enrolled.

Robert J. DeLuccia

And Ed, this is Bob. Just to reiterate, too, the 2 Phase III trials are straightforward from the FDA guidelines, October 22, I think it was, guidelines. And that's a very clear path for what's needed for approval and an NDA.

Operator

(Operator Instructions) Your next question is coming from Mike Boyd, a private investor.

Unidentified Participant

Thank you for the update. It's very exciting, and I can't wait to see the next steps. I had a quick question, easy one I hope. Has the company considered a priority review voucher for this application?

David P. Luci

Thanks for the question, Mike. Bob, do you want to hit that one?

Robert J. DeLuccia

Yes. I mean we already have priority review because of our FDA fast track status. So we already have that.

Unidentified Participant

Yes. But the voucher itself is actually -- there's value to that. You could actually sell that if you chose. Current market value is about $100 million. So looking at that as a source of possible funding at some point.

Robert J. DeLuccia

We could certainly take a look.

Unidentified Participant

Okay. Cool. I mean the timing is right to begin thinking about it. It's associated with the NDA. So it's time to put it on the radar if it's something that the FDA would consider.

David P. Luci

Okay.

Operator

Your next question today is coming from James Molloy from Alliance Global Partners.

James Francis Molloy

Guys, I apologize if I missed it on the call. Did you guys state when you anticipate starting the first of the 2 Phase IIIs? And can you walk us through what the all-in cost on the Phase IIIs are anticipated?

David P. Luci

Thanks, Jim, and good morning. We hope to start -- we will be ready to start in the fourth quarter of this year with enrollment with our manufacturing update that we recently received. So we hope to be funded satisfactorily by then in order to start. So that's the gating factor. But yes, we hope to start in the fourth quarter, and then enrollment should take 18 to 24 months. And it's difficult for us to guesstimate exactly how much this is going to cost, because we have a lot of partnering discussions currently ongoing and they're all different. And they all have various internal capabilities that dramatically impact what the Phase III mandate will cost. It's certainly something in the $50 million to $60 million range if we were to do it all independently ourselves. So a partnership would be an appropriate course.

James Francis Molloy

How would you characterize the current partnership environment? And obviously, after Phase III, it's your best deal, you're obviously not there. But how do you characterize sort of going into Phase III, the partnership opportunities you're seeing?

David P. Luci

I would characterize it as pretty robust. I mean, probably my last 20 e-mails in my inbox are people wanting to meet me, and I haven't even looked at the e-mails yet. That's just from overnight. I mean, it's just a lot of interest, and we may not be enrolling in Phase III, but we're Phase III ready. And we know we have a drug from our Phase IIb data. So we have to be patient and we have to take the right deal.

And when things come along that are going to constitute 60% of the company being lost to a round of investment, then sometimes it's the deals that you don't do that make the most sense. So we're trying to be judicious about raising capital as nondilutively as possible, knowing that we have a drug, and we're Phase III ready. And there aren't a lot of Phase III antibiotics out there right now, especially not in a $1 billion-plus market, where you have a reasonable chance to be frontline therapy.

James Francis Molloy

Maybe last questions on my end. On the design, I know that, obviously, 1 year, 1.5 years to get to run the first of the Phase IIIs. Is there an opportunity for any interim looks and any thoughts on timing on that? And then any update on the PASTEUR Act? What's going on?

David P. Luci

Yes, I'll leave that -- the question on the PASTEUR Act, I'll leave to Bob. There's some new legislation -- actually old legislation that may be expanded to include antibiotics that treat life-threatening infections that Katie Britt in the Senate has gotten in touch with the Health and Human Services about, but I'll let Bob talk about that.

But the interim look thing, that's kind of like a head fake. I know it's NBA playoff time. So for you NBA fans, the interim look, that would go through an independent committee of scientists and doctors. And if you take an interim look, you necessarily statistically have to add patients to the trial. And the interim look doesn't give you any sense of, percentage-wise, how you're doing with the primary endpoint or secondary endpoints. All it does is this group of experts tell you to either keep going or to stop due to futility. So for the amount of information you get out of that, to me, is not worth adding millions of dollars in time to a trial.

Robert J. DeLuccia

Yes. I agree with you, Dave, on that, for sure. And I hope that answers the question. But remember, this is a blinded trial. So you really can't break the blind. You've got to continue to proceed. I think there was a second question here regarding...

David P. Luci

It was about PASTEUR Act.

Robert J. DeLuccia

What was the question?

David P. Luci

What's going on with the PASTEUR Act?

Robert J. DeLuccia

Yes, PASTEUR Act. There's a lot of effort to try to get that through. Really unlikely going to occur this year under the current political environment. However, there is some activity with a special program that requires a drug to be determined as a material threat in order to get some additional funding from a government organization called BARDA for new classes of antibiotics that are in late-stage clinical trials, namely Phase III.

So this is being circulated as pending legislation, trying to move it forward this year. I wouldn't put a high probability that it's going to get through this year. But if it does, we'll be able to tap into that for some partial funding for our Phase III program.

David P. Luci

Actually, just a slight nuance on that is that the legislation is actually old. It's been approved a long time ago. So what needs to happen is that the scope of the program would need to be expanded, which I understand can be done by HHS on their own. It would need to be expanded to include antimicrobials that treat life-threatening infections. So it doesn't rise to the level of needing a new law, the law is there, it's just the program needs to be expanded to include this new class of things that ultimately would be stockpiled by the Federal government through the Department of Defense.

Operator

We've reached the end of our question-and-answer session. I'd like to turn the floor back over for any further or closing comments.

David P. Luci

We'd just like to thank everyone for participating today, and thank you for your patience and the best is yet to come.

Operator

Thank you. That does conclude today's teleconference. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.

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>>> Acurx Pharmaceuticals Inc (ACXP) Q1 2024 Earnings Call Transcript Highlights: Key Financial and ...


GuruFocus Research

May 16, 2024


https://finance.yahoo.com/news/acurx-pharmaceuticals-inc-acxp-q1-070055271.html


Cash Position: $8.9 million as of March 31, 2024, up from $7.5 million as of December 31, 2023.

Net Loss: $4.4 million or $0.28 per diluted share for Q1 2024, compared to a net loss of $2.9 million or $0.25 per diluted share for Q1 2023.

Research and Development Expenses: $1.6 million for Q1 2024, up from $1 million for Q1 2023.

General and Administrative Expenses: $2.8 million for Q1 2024, up from $1.9 million for Q1 2023.

Shares Outstanding: 15,757,102 as of March 31, 2024.

ATM Financing: Sold an additional 1,121,793 shares with gross proceeds of approximately $4.4 million during Q1 2024.

Release Date: May 15, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

Ibezapolstat showed superior efficacy in eradicating C. difficile compared to vancomycin in Phase IIb trials, with a 94% success rate versus 71% for vancomycin.

Ibezapolstat has demonstrated the ability to preserve and allow regrowth of key gut bacteria, potentially reducing the recurrence of C. diff infections.

Acurx Pharmaceuticals Inc (NASDAQ:ACXP) has successfully reached agreement with the FDA on key elements of the Phase III program, indicating readiness to proceed to the next phase of clinical trials.

The company has secured SME status in Europe, providing benefits such as fee reductions and support from the European Medicines Agency.

Acurx Pharmaceuticals Inc (NASDAQ:ACXP) has a robust financial position with an increase in cash from $7.5 million to $8.9 million and successful additional share sales generating $4.4 million.

Negative Points

The company reported an increased net loss of $4.4 million for Q1 2024, up from $2.9 million in the same period the previous year.

Research and development expenses increased significantly, from $1 million to $1.6 million, due to higher manufacturing-related costs.

General and administrative expenses also rose from $1.9 million to $2.8 million, driven by increases in professional fees and noncash share-based compensation.

Acurx Pharmaceuticals Inc (NASDAQ:ACXP) is still in the process of finalizing costs and timelines for Phase III trials, indicating potential uncertainties in future expenditures.

The company has not yet secured any commitments from potential partners for further development and commercialization of ibezapolstat, despite active discussions.

Q & A Highlights

Q: Bob, can you confirm the total number of subjects for the upcoming trial and clarify if the Phase IIb is considered one of the two pivotal studies required by the FDA? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - The total number of subjects for each of the two Phase III registration trials is 450, making it 900 in total. The Phase IIb is not considered a registration trial due to its small size. The upcoming trials are necessary to build a satisfactory safety database for an NDA application.

Q: Could you provide any preliminary information on the costs and timelines for the upcoming trials? Also, are there any active discussions regarding strategic partnerships? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - We are currently finalizing the costs and timelines. Discussions about partnerships are active, especially now that we have a clear pathway for a pivotal study. We are engaging in several discussions, but nothing is finalized yet.

Q: When do you anticipate starting the first of the two Phase III trials? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - We aim to start enrollment in the fourth quarter of this year, contingent on adequate funding. The enrollment is expected to take 18 to 24 months.

Q: Has the company considered applying for a priority review voucher for this application? A: Robert J. DeLuccia - Co-Founder & Executive Chairman, Acurx Pharmaceuticals, Inc. - We already have priority review due to our FDA fast track status. However, we are open to exploring the possibility of a priority review voucher, which could be a significant source of funding.

Q: Can you discuss the partnership environment as you approach Phase III? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - The environment is quite robust. We have a lot of interest from potential partners, and we are being judicious in our discussions to ensure we make the right deal without overly diluting our company.

Q: Is there an opportunity for any interim looks during the Phase III trials, and could you update us on the PASTEUR Act? A: David P. Luci - Co-Founder, President, CEO, Corporate Secretary & Director, Acurx Pharmaceuticals, Inc. - We do not plan to conduct interim looks as they require adding patients and do not provide significant insights. Regarding the PASTEUR Act, it is unlikely to pass this year, but we are monitoring potential funding opportunities for new classes of antibiotics through other government programs.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

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>>> Acurx Pharmaceuticals to Present at the Microcap Conference, January 31, 2024 - February 1, 2024


PR Newswire

January 23, 2024


https://finance.yahoo.com/news/acurx-pharmaceuticals-present-microcap-conference-120100998.html


STATEN ISLAND, N.Y., Jan. 23, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. ("Acurx" or the "Company") (NASDAQ: "ACXP"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that David P. Luci, President & Chief Executive Officer, will be presenting at The Microcap Conference, which will take place January 30, 2024-February 1, 2024 at the Ceasars Atlantic City Hotel & Casino in Atlantic City, New Jersey.

Presentation Details:

Wednesday, January 31st, 2 pm ET and
Thursday, February 1st at 11:40 am ET

Interested parties can register to attend here.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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>>> Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients


Yahoo Finance

January 17, 2024


https://finance.yahoo.com/news/acurx-announces-positive-comparative-microbiology-120100113.html


Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%).

Ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI

Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days

Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials

Ibezapolstat has previously received FDA QIDP and Fast-Track Designation


STATEN ISLAND, N.Y., Jan. 17, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. Data showed that ibezapolstat outperformed vancomycin, a standard of care to treat patients with CDI, with eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 patients (94%) versus vancomycin which had eradication of fecal C. difficile in 10 of 14 patients (71%). In addition, ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent CDI recurrence. Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days. Preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials.

The Company also announced that a scientific poster will be presented on January 18, 2023 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 and Acurx Scientific Advisory Board member. The poster will show comparative data details from the Phase 2b clinical trial entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides difficile Infection."

After the presentation, the poster will be posted on Acurx website: www.acurxpharma.com

According to Dr. Garey: "These results help validate our ongoing scientific investigations into the anti-CDI recurrence effects of ibezapolstat. Our microbiologic findings show that markedly fewer patients treated with ibezapolstat had persistent C. difficile compared to patients treated with vancomycin. He further stated: "Preservation of key health-conferring native gut bacteria, such as Firmicutes, in patients treated with ibezapolstat has now been shown consistently during all clinical studies. These results correlate with prior findings by showing superior preservation of key native gut bacteria compared to vancomycin in CDI patients. Preservation of native gut bacteria during treatment for CDI is believed to be a key component for preventing recurrence of CDI. These findings will need to be further validated in the phase 3 studies but the results to date support the importance of this new class of antibiotics with a novel mechanism of action that does not target native gut bacteria."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "These new comparative data are very important and timely to enhance our data package for an end of Phase 2 FDA Meeting which is targeted for second quarter this year. He further stated: "Parallel preparations continue on schedule for Phase 3 clinical trials start up later this year, including timely availability of clinical trial supply.

David P. Luci, President & CEO of Acurx, stated: "Ibezapolstat continues to demonstrate success compared to a standard of care, oral vancomycin, to treat patients with CDI. We anticipate that favorable differentiation between the two therapeutic options will continue to be shown in Q1 2024 including extended clinical cure and additional microbiome comparison data. We expect to leverage this success in a $1 billion plus US CDI global market as we move forward with an international Phase 3 clinical trial mandate." He added: "The Company also anticipates its price point for ibezapolstat, if approved, could meet or beat other antibiotics recommended for use in treating patients with CDI, thereby providing the whole package of clinical comparability with microbiome health, safety and cost for patients with this life-threatening disease."

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti- recurrence microbiome properties seen in the Phase 2a trial, including the treatment- related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment. The Company's Scientific Advisory Board concurred with this recommendation.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October, 2022).

The Phase 2b clinical trial segment was discontinued due to success. The Company made this decision in consultation with its 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. The Company had 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. The Company anticipated that this decision would allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.

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 assessment. The Company determined, in consultation with its 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.

In the Phase 2 clinical trial, the Company will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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.

About Ibezapolstat

Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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[gfp927z]

The microbiome comparison data is good, so next up is the 94 day extended duration data, which will be the key. In December they released the 1 month sustained cure data, which was a perfect 100% (no relapses), so the 94 day data is next. That 94 day data will determine the strength of upcoming pharma partnering and / or buyout offers.

I figure one reason the stock has been selling off on good news is that they now have an 'ATM' in place (since November), by which they can raise money (up to $17 mil) via the periodic selling of shares into the market. Luci said the first Phase 3 will cost in the $15-18 mil range, and the ATM is how they plan to pay for it, without having to do a big regular type money raise. With the ATM approach they can gradually raise the money over time, so it's an excellent way to raise funds. But for investors it does create the expectation that the company will likely be selling shares into good news, so that expectation can tend to blunt the upside moves in the stock.

Luci has said that his preference 'Plan A' is for an MA (buyout) prior to running the Phase 3. Next preference would be a pharma partner, who will pay for and run the Phase 3s, and third choice is to finish raising the $17 mil via the ATM and run the first Phase 3 in-house, and then partner or MA after that Phase 3 is complete, or has an interim data analysis.

Luci has a finance background, and having the ATM available as a key funding mechanism gives him leverage in pharma negotiations. He has full access to that ATM money, without actually having to do the money raise. The last thing you want in pharma negotiations is for your company to be running on fumes, and the ATM insures that it isn't, so it's a big plus going into negotiations.

Anyway, just my 2 cents..



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[Squeejo]

POS sold off again!!!!

[tw0122]

ACXP good diarrhea trials .. Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

Source: PR Newswire (US)
Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%).
Ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI
Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days
Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials
Ibezapolstat has previously received FDA QIDP and Fast-Track Designation
STATEN ISLAND, N.Y., Jan. 17, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. Data showed that ibezapolstat outperformed vancomycin, a standard of care to treat patients with CDI, with eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 patients (94%) versus vancomycin which had eradication of fecal C. difficile in 10 of 14 patients (71%). In addition, ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent CDI recurrence. Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days. Preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials.

The Company also announced that a scientific poster will be presented on January 18, 2023 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 and Acurx Scientific Advisory Board member. The poster will show comparative data details from the Phase 2b clinical trial entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides difficile Infection."

After the presentation, the poster will be posted on Acurx website: www.acurxpharma.com

According to Dr. Garey: "These results help validate our ongoing scientific investigations into the anti-CDI recurrence effects of ibezapolstat. Our microbiologic findings show that markedly fewer patients treated with ibezapolstat had persistent C. difficile compared to patients treated with vancomycin. He further stated: "Preservation of key health-conferring native gut bacteria, such as Firmicutes, in patients treated with ibezapolstat has now been shown consistently during all clinical studies. These results correlate with prior findings by showing superior preservation of key native gut bacteria compared to vancomycin in CDI patients. Preservation of native gut bacteria during treatment for CDI is believed to be a key component for preventing recurrence of CDI. These findings will need to be further validated in the phase 3 studies but the results to date support the importance of this new class of antibiotics with a novel mechanism of action that does not target native gut bacteria."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "These new comparative data are very important and timely to enhance our data package for an end of Phase 2 FDA Meeting which is targeted for second quarter this year. He further stated: "Parallel preparations continue on schedule for Phase 3 clinical trials start up later this year, including timely availability of clinical trial supply.

David P. Luci, President & CEO of Acurx, stated: "Ibezapolstat continues to demonstrate success compared to a standard of care, oral vancomycin, to treat patients with CDI. We anticipate that favorable differentiation between the two therapeutic options will continue to be shown in Q1 2024 including extended clinical cure and additional microbiome comparison data. We expect to leverage this success in a $1 billion plus US CDI global market as we move forward with an international Phase 3 clinical trial mandate." He added: "The Company also anticipates its price point for ibezapolstat, if approved, could meet or beat other antibiotics recommended for use in treating patients with CDI, thereby providing the whole package of clinical comparability with microbiome health, safety and cost for patients with this life-threatening disease."

About the Ibezapolstat Phase 2 Clinical Trial
The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti- recurrence microbiome properties seen in the Phase 2a trial, including the treatment- related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment. The Company's Scientific Advisory Board concurred with this recommendation.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October, 2022).

The Phase 2b clinical trial segment was discontinued due to success. The Company made this decision in consultation with its 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. The Company had 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. The Company anticipated that this decision would allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.

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 assessment. The Company determined, in consultation with its 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.

In the Phase 2 clinical trial, the Company will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, 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. difficile. 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.

About Ibezapolstat
Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism
C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

[gfp927z]

The replay of the Jan 11 JP Morgan presentation is up on Acurx's website (links below). Luci said all the remaining data should be out in Jan, and includes the extended durability (94 day), microbiome comparison data, and microbiology comparison data. So the next 2 weeks should be very interesting :o)


https://d3ua9t66dzwd8a.cloudfront.net/HC24/p_50099_Acurx.mp3


https://ir.acurxpharma.com/





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[gfp927z]

The JP Morgan conference presentation is tomorrow, and there was also a new Fox interview with Luci (below) that aired last Monday (interview was taped before Christmas). So anticipation is building :o)

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[gfp927z]

>>> Acurx to present at the 42nd Annual J.P. Morgan Healthcare Conference


PR Newswire

January 3, 2024


https://finance.yahoo.com/news/acurx-present-42nd-annual-j-130000189.html


STATEN ISLAND, N.Y., Jan. 3, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") today announced that President and Chief Executive Officer David P. Luci will present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 12:00 pm PST. An audio webcast of the presentation will be available live at https://jpmorgan.metameetings.net/events/healthcare24/sessions/50099-acurx-pharmaceuticals-inc/webcast?gpu_only=true&kiosk=true and will be available upon completion of the conference on the Company's website at www.acurxpharma.com under the Investors section.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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