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].

Financial Data and Key Metrics Changes - The company ended Q1 2023 with cash totaling $7.2 million, down from $9.1 million as of December 31, 2022 [15] - Research and development expenses for Q1 2023 were $1 million, an increase from $800,000 in Q1 2022, attributed to Phase 2b trial costs [15] - General and administrative expenses remained flat at $1.9 million for both Q1 2023 and Q1 2022 [15] - The company reported a net loss of $2.9 million or $0.25 per diluted share for Q1 2023, compared to a net loss of $2.7 million or $0.26 per diluted share for Q1 2022 [15] Business Line Data and Key Metrics Changes - The Phase 2b clinical trial for ibezapolstat is ongoing, with an increase in trial sites from 12 to 28 due to slower-than-expected patient enrollment [5][6] - The primary endpoint of the trial is clinical cure at the end of treatment, with a secondary endpoint of sustained clinical cure at day 38 [5] Market Data and Key Metrics Changes - The company is actively pursuing funding from CARB-X for its second antibiotic candidate targeting MRSA infections, with a decision expected by October 2023 [11][12] - The company is also involved in a research collaboration with Leiden University Medical Center, supported by a grant from the Dutch government [10] Company Strategy and Development Direction - The company is focused on advancing its antibiotic pipeline, particularly ibezapolstat, which aims to treat C. difficile infections while managing the microbiome [7][8] - The company is optimistic about the potential impact of the PASTEUR Act on antibiotic development and funding for clinical trials [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase 2b trial, noting exceptional blinded data with high cure rates [28][32] - The company anticipates completing enrollment of 36 patients in the second half of 2023, with a conservative approach to timelines [21] Other Important Information - The company presented at the ECCMID Conference in April 2023, highlighting the unique mechanism of action of ibezapolstat [8][9] - The company is awaiting a decision on a non-dilutive grant application to CARB-X, which could provide significant funding for its antibiotic programs [11][12] Q&A Session Summary Question: What are the major factors behind the change in the interim analysis timeline for the Phase 2b study? - Management indicated that the timeline was adjusted to provide a conservative cushion, with expectations for completion in the second half of 2023 [21] Question: What other efficacy endpoints can investors look for in the interim analysis? - Management expects to see efficacy rates between 90% and 100%, based on previous trial data [22][23] Question: Can you elaborate on the exceptional blinded data mentioned? - Management reported almost all cures observed in the blinded data, indicating strong efficacy [28] Question: What are the unique challenges faced in the Phase 2b recruitment compared to Phase 2a? - Challenges include changes in clinical trial culture post-COVID, requiring patients to travel to trial sites quickly after diagnosis [36][44] Question: What does "active review" mean in the context of CARB-X funding? - Management explained that active review indicates the application is still under consideration, with most candidates typically facing rejection [38] Question: What should be monitored regarding the PASTEUR Act? - Management noted that the expectation is for the Act to be included in legislation by the end of Q3, with potential funding implications for antibiotic development [39]