UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________ FORM 10-K _____________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40536 Acurx Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) ...

STATEN ISLAND, N.Y., March 4, 2024 /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 release its fourth quarter and full year 2023 financial results on Monday, March 18, 2024, 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 ...

As previously announced, planning is underway with FDA to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI) As anticipated, an End of Phase 2 Meeting (EOP2) with FDA is now confirmed to occur in late April 2024 to finalize the Phase 3 development plan Per FDA Guidance, Acurx also announced it has submitted the required pre-meeting Briefing Document to FDA yesterday, February 26, 2024 SME (Small and Medium-sized Enterprise) designation has been gra ...

NEW YORK, Feb. 02, 2024 (GLOBE NEWSWIRE) -- FMW Media's New to The Street is airing its national TV show on the FOX Business Network on Monday, February 5, 2024, at 10:30 PM. New to The Street's 553rd episode features the following five (5) corporate interviews: 1). Vacation Property Management – The Compass Collection's interviews with Heather Plampin, President/CEO, and Matt Farhat, Head of Business Development. 2). Decentralized Supercomputing – Dynex's (CRYPTO: DNX) ($DNX) interview with Clifford Mapp, ...

NEW YORK, Feb. 01, 2024 (GLOBE NEWSWIRE) -- FMW Media's New to The Street TV announces the broadcasting of its business show airing on Bloomberg TV as sponsored programming tonight, Thursday, February 1, 2024, at 9:30 PM PT. New to The Street's TV episode #552 will air the following five (5) business interviews: 1). Biopharmaceutical - Acurx Pharmaceuticals, Inc.'s (NASDAQ:ACXP) ($ACXP) interview with David Luci, President/CEO. 2). Decentralized Supercomputing – Dynex's (CRYPTO: DNX) ($DNX) interview with C ...

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 Further analyses will be forthcoming as data become available regarding effects on bile acid metabolism and pharmacokinetic data Preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials Ibezapolstat has previousl ...

NEW YORK, Jan. 26, 2024 (GLOBE NEWSWIRE) --  FMW Media's New to The Street, a national TV show, announces episode 551, airing on the FOX Business Network on Monday, January 29, 2024, at 10:30 PM PT. New to The Street's 551st episode line-up features the following Five (5) Corporate interviews: 1). Biopharmaceutical -Acurx Pharmaceuticals, Inc.'s (NASDAQ:ACXP) ($ACXP) interview with David Luci, President/CEO. 2). Financial Marketplace Strategies – Blue Castle Ventures LTD's ($BCVD) interviews with David Roja ...

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. P ...

Core Viewpoint - Acurx Pharmaceuticals' shares experienced a significant decline despite positive data regarding its novel C. diff antibiotic, ibezapolstat, which reportedly outperformed vancomycin in preserving the gut microbiome during treatment [1][11] Share Price Decline Reasons - The decline in share price is not attributed to bad data, as most efficacy data is available; rather, it may stem from misaligned investor expectations regarding the anticipated release of 94-day efficacy data [2] - The company confirmed it did not utilize its ATM facility during the press release, suggesting that the sell-off was not due to capital raising activities [2] Data Release - Acurx's data release was limited to a general success statement, with detailed results reserved for a conference presentation; investors can expect the 94-day sustained clinical cure rates to be released soon [3] - The gut microbiome study may position ibezapolstat as a preferred antibiotic for C. diff treatment [3] C. Difficile Infection Recurrence Rates - Ridinilazole, another C. diff antibiotic, failed a phase 3 trial, showing similar performance to vancomycin but with a lower recurrence rate [4] - Acurx's ibezapolstat demonstrated a 100% clinical cure rate in a small sample, raising questions about the reliability of this data [5] - The microbiome data suggests that ibezapolstat may not be an outlier, but confirmation through the upcoming 94-day data is necessary [5] Phase 3 Trial Considerations - Acurx may benefit from focusing on endpoints that highlight ibezapolstat's strengths, such as gut microbiome preservation, rather than solely on cure rate superiority over vancomycin [7] Upcoming Catalysts - The most significant upcoming catalyst is the confirmation of efficacy through the release of 94-day extended clinical cure rates, which is crucial for investor confidence [8] Financial Overview - Acurx had $7.1 million in cash as of September 2023, with a need for additional funding for a phase 3 trial; the company may have utilized its ATM facility to bolster its cash balance [9] - The company’s market cap is relatively small, raising concerns about its ability to execute licensing deals or avoid dilution [9]

Core Insights - Acurx Pharmaceuticals announced that its lead antibiotic candidate, ibezapolstat, demonstrated superior efficacy compared to vancomycin in eradicating fecal C. difficile in a Phase 2b clinical trial, achieving a 94% eradication rate versus vancomycin's 71% [1][3][6] - Ibezapolstat preserved key gut bacterial species that are believed to help prevent recurrence of Clostridioides difficile infection (CDI), a significant advantage over vancomycin [1][2][11] - The company is preparing for meetings with regulatory agencies and advancing towards international Phase 3 clinical trials, following positive results from the Phase 2b trial [1][3][12] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, including CDI [16] - The company’s lead candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS™) antibiotic that inhibits DNA polymerase IIIC, contributing to its unique mechanism of action [11][16] - Ibezapolstat has received FDA designations such as Qualified Infectious Disease Product (QIDP) and Fast-Track, highlighting its potential in addressing urgent medical needs [12][16] Clinical Trial Insights - The Phase 2b trial involved 32 patients with CDI, randomized to receive either ibezapolstat or vancomycin, with a follow-up period to assess recurrence [6][8] - The overall clinical cure rate for ibezapolstat across both Phase 2 trials was 96%, indicating strong efficacy [6][8] - The trial was discontinued early due to the observed success, allowing for expedited progression to Phase 3 trials [7][8] Market Potential - The U.S. CDI market is estimated to exceed $1 billion, and Acurx anticipates that ibezapolstat could be competitively priced compared to existing antibiotics [3][12] - The company aims to leverage its clinical data to differentiate ibezapolstat in the market, focusing on both efficacy and microbiome health [3][12] Future Developments - Further analyses from the Phase 2b trial, including Extended Clinical Cure (ECC) data, are expected in Q1 2024 [1][2] - Acurx is preparing for an end of Phase 2 meeting with the FDA, targeted for the second quarter of 2024, to discuss the next steps for ibezapolstat [2][3]