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]

NEW YORK, Jan. 05, 2024 (GLOBE NEWSWIRE) -- FMW Media's New to The Street, a nationally broadcasted TV show, announces episode 543, airing on the Fox Business Network, Monday, January 8, 2024, at 10:30 PM PT. New to The Street's 543rd TV episode line-up features the following four (4) Corporate interviews: 1). Biopharmaceutical – Acurx Pharmaceuticals, Inc.'s (NASDAQ:ACXP) ($ACXP) interview with David Luci, President/CEO. 2). "Game Changers Segment" interview with Dr. Navjit Dhaliwal, CEO, IAGON (CRYPTO: IA ...

Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q3 2023 Earnings Conference Call November 14, 2023 8:00 AM ET Company Participants Robert Shawah - CFO David Luci - President & CEO Robert DeLuccia - Executive Chairman Conference Call Participants Michael Okunewitch - Maxim Group Thomas Yip - H.C. Wainwright James Molloy - Alliance Global Partners Operator Ladies and gentlemen, good morning, and welcome to the Acurx Pharmaceuticals Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Quarterly Period Ended September 30, 2023 Or ☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission File Number 001-40536 Acurx Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Delaware 82-3733567 State or other jurisdiction of (I.R.S. Employer incorporation ...

Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Rob Shawah - CFO Dave Luci - President and CEO Conference Call Participants Ed Arce - HC. Wainwright Michael Okunewitch - Maxim Group Jim Molloy - Alliance Global Partners Operator Greetings, and welcome to the Acurx Pharmaceuticals to discuss Second Quarter 2023 Financial Results and Business Update. At this time, all participants are in a listen-only mode. A brief question and answer ...

Antibiotic Development - The Company is developing a new class of antibiotics targeting priority pathogens identified by WHO, CDC, and FDA, addressing the global crisis of antimicrobial resistance [77]. - The lead antibiotic candidate, ibezapolstat, demonstrated a 100% response rate in the Phase 2a clinical trial, with all 10 patients achieving Clinical Cure and no serious adverse events reported [83]. - The Phase 2b clinical trial for ibezapolstat commenced enrollment on December 3, 2021, with 31 patients currently enrolled and an Independent Data Monitoring Committee set to review interim data [86]. - The Referring Physician Program launched in July 2022 aims to enhance patient enrollment in the Phase 2b clinical trial, targeting high-prescribing physicians within a 25-mile radius of trial sites [87]. - The Company increased the number of clinical trial sites for the Phase 2b trial from 12 to 28 to optimize patient enrollment [90]. - The Company’s early-stage pipeline includes ACX-375C, targeting Gram-positive bacteria, including MRSA and VRE, with established proof of concept in animal studies [84]. - The Company’s protocol amendment accepted by the FDA allows for interim clinical data review by an Independent Data Monitoring Committee [86]. - The CDC estimates that antibiotic-resistant pathogens infect one individual every 11 seconds in the U.S., highlighting the urgency of developing new antibiotics [77]. Financial Performance - The company reported a net loss of $3.4 million for the three months ended June 30, 2023, compared to a net loss of $2.6 million for the same period in 2022, representing a 31% increase in net loss [119]. - Research and development expenses increased to $1.7 million for the three months ended June 30, 2023, up 90% from $0.9 million in the same period in 2022, primarily due to Phase 2b clinical trial costs [118]. - Total operating expenses for the three months ended June 30, 2023, were $3.4 million, a 31% increase from $2.6 million in the same period in 2022 [116]. - For the six months ended June 30, 2023, research and development expenses were $2.8 million, a 59% increase from $1.7 million in the same period in 2022 [121]. - The company has incurred cumulative losses of approximately $44.9 million as of June 30, 2023, with no revenue generated since inception [123]. - As of June 30, 2023, the company had working capital of $6.2 million, consisting primarily of $9.1 million in cash [124]. - The company completed a registered direct offering on May 18, 2023, resulting in net proceeds of approximately $3.5 million after deducting placement agents fees and offering costs [123]. - General and administrative expenses remained stable at $1.7 million for the three months ended June 30, 2023, compared to the same period in 2022 [118]. - The company anticipates increased general and administrative expenses in the future to support ongoing research and development activities [114]. - The company has funded its operations primarily through equity issuances, including net cash proceeds of approximately $14.8 million from its IPO on June 29, 2021 [123]. - Net cash used in operating activities was $3.5 million for the six months ended June 30, 2023, an increase from $3.9 million in the same period of 2022 [126][127]. - The net loss for the six months ended June 30, 2023, was greater than the net cash used in operating activities by $2.8 million, primarily due to share-based compensation and vendor payments [126]. - Net cash provided from financing activities was $3.5 million for the six months ended June 30, 2023, attributed to net proceeds from a registered direct offering [127]. - Share-based compensation and vendor payments accounted for $1.7 million in both periods, indicating a consistent expense level [126]. Accounting and Compliance - The company expenses research and development costs when incurred, with cash advances deferred until services are provided [130]. - The company utilizes estimates based on historical experience and known trends for accrued expenses and stock-based compensation, which may differ from actual results [128]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards [135][136]. - Recent accounting pronouncements are not expected to significantly impact the company's financial measurements or disclosures [137].