Antibiotic Development - The company is developing a new class of small molecule antibiotics targeting difficult-to-treat Gram-positive bacterial infections, with a focus on Clostridioides difficile, MRSA, VRE, and DRSP[67][71]. - The Phase 2 clinical trial for the lead antibiotic candidate, ibezapolstat, showed a Clinical Cure rate of 96% across both Phase 2a and Phase 2b segments, compared to a historical vancomycin cure rate of approximately 81%[80]. - In the Phase 2b segment, 100% of ibezapolstat-treated patients who achieved Clinical Cure remained free of CDI recurrence through one month after treatment, while the standard of care (vancomycin) had a recurrence rate of 14%[81]. - The company plans to conduct Phase 3 clinical trials for ibezapolstat and has received confirmation of Phase 3 readiness from the FDA, with agreements on key elements for the international trial program[84]. - The company has a pipeline of early-stage antibiotic candidates, including ACX-375C, targeting Gram-positive bacteria, which has shown proof of concept in animal studies[76]. - Recent analyses indicated that ibezapolstat positively affects the gut microbiome, contributing to its anti-recurrence effect for CDI[78]. - A new patent was granted for ibezapolstat, focusing on its use to treat CDI while improving gut microbiome health, adding to the company's intellectual property portfolio[85]. - The company is evaluating strategic transactions for further development and potential commercialization of ibezapolstat, including partnerships or mergers[77]. Financial Performance - The company has not generated any revenue since inception and does not expect to do so in the near future[92]. - Research and development expenses for Q3 2024 were $1.2 million, a decrease of 11% from $1.3 million in Q3 2023[99]. - General and administrative expenses for Q3 2024 were $1.6 million, down 8% from $1.8 million in Q3 2023[101]. - Total operating expenses for Q3 2024 were $2.8 million, a 9% decrease compared to $3.1 million in Q3 2023[99]. - Net loss for Q3 2024 was $2.8 million, a reduction of 9% from $3.1 million in Q3 2023[102]. - Research and development expenses for the nine months ended September 30, 2024, increased by 12% to $4.6 million from $4.1 million in the same period of 2023[103]. - General and administrative expenses for the nine months ended September 30, 2024, rose by 26% to $6.7 million from $5.4 million in the same period of 2023[104]. - Total operating expenses for the nine months ended September 30, 2024, were $11.3 million, a 20% increase from $9.5 million in the same period of 2023[103]. - Cumulative losses as of September 30, 2024, amounted to approximately $64.5 million, with no revenue generated from operations[105]. - As of September 30, 2024, the company had working capital of $2.7 million, primarily consisting of $5.8 million in cash[107]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $8.1 million, compared to $5.6 million for the same period in 2023[108]. Accounting and Regulatory Updates - The FASB issued ASU 2023-09, effective for fiscal years beginning after December 15, 2024, which expands income tax disclosures[120]. - The company is currently evaluating the effect of the new accounting pronouncement on its disclosures[120]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[121].

Readers familiar with my prior research on Acurx Pharmaceuticals (NASDAQ: ACXP ) know that I have a generally negative view on the antibiotics subsector of drug development due to many new antibiotics being used as a Analyst's Disclosure: I/we have a beneficial long position in the shares of ACXP either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no busine ...

STATEN ISLAND, N.Y. , Oct. 17, 2024 /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 that the Company will participate in the Spartan Capital inaugural investor conference on November 4, 2024 at the Pierre Hotel in New York, New York. This participation aligns with our commitment to engage with industry leaders and investors. Our pre ...

STATEN ISLAND, N.Y., Oct. 16, 2024 /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 that the Company will discuss its third quarter 2024 financial results on Wednesday, November 13, 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 Financial Of ...

New analyses extend data on beneficial effects of ibezapolstat on the gut microbiomeConfirmed ibezapolstat's favorable pharmacokinetics showing low systemic exposure and high colonic concentrationsSelected 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 internati ...

Acurx Pharmaceuticals, Inc. (NASDAQ:ACXP) Q2 2024 Earnings Conference Call August 9, 2024 8:00 AM ET Company Participants Robert Shawah - CFO David Luci - President & CEO Robert DeLuccia - Executive Chairman Conference Call Participants Jason McCarthy - Maxim Group Thomas Yip - H.C. Wainwright James Molloy - Alliance Global Partners Operator Greetings. Welcome to the Acurx Pharmaceuticals Second Quarter 2024 Financial Results. At this time, all participants are in listen-only mode. Question-and-answer sessi ...

Exhibit 99.1 For Immediate Release — 7:01 am ET on Friday, August 9, 2024 Acurx Pharmaceuticals, Inc. Reports Second Quarter 2024 Results and Provides Business Update Staten Island, NY, August 9, 2024 — 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. Highli ...

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 Clin ...

Table of Contents f 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 June 30, 2024 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 incorporation o ...

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 infe ...