Acurx Pharmaceuticals, Inc. Reports Third Quarter 2026 results and provides business update
STATEN ISLAND, N.Y., Nov. 12, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for serious or life-threatening bacterial infections, announced today certain financial and operational results for the third quarter ended September 30, 2026.
Highlights of the third quarter ended September 30, 2026, or in some cases shortly thereafter, include:
- In July 2026, the Company's R&D team met with the FDA for the purpose of seeking their guidance on our plan to conduct a single phase 3 study in acute CDI and its acceptability as a pivotal trial for filing a New Drug Application (or NDA). We reported the outcome of this meeting in more detail in our August 3rd press release. The FDA stated that it is open to further discussion on the totality of evidence from the ibezapolstat clinical development program at a pre-NDA meeting after completion of a single Phase 3 trial, called IBZ-ASPIRE, for the acute treatment of CDI, and the data from the PATHFINDER trial that is currently enrolling patients in recurrent CDI. Based on our discussions, FDA will focus on whether our clinical efficacy data from PATHFINDER and ASPIRE is robust to support an NDA submission.
- On September 29, 2026, we began enrolling patients in PATHFINDER, a ground-breaking 20 patient clinical trial in multiply-recurrent CDI. This trial was acknowledged by FDA as being significant and along with robust results from our IBZ-ASPIRE Ph3 pivotal trial, may form the basis for a potential approval for the treatment for Ibezapolstat in both acute CDI and prevention of recurrence.
- The PATHFINDER trial is fully funded and if successful, will elevate the product profile of IBZ. If the PATHFINDER trial is successful, we may have the flexibility to conduct a pivotal Phase 3 trial (PATHFINDER II) in recurrent CDI under the FDA's LPAD Pathway instead of conducting the ASPIRE trial in acute CDI to gain approval.
- In July 2026, we signed a continuation of our scientific partnership with Leiden University Medical Center to advance development of Acurx's DNA pol IIIC Inhibitors. This new partnership builds on the previously reported successful results from the innovative research grants received in August 2021 and in November 2025 from Health-Holland to Leiden University and Acurx. This continuing partnership will enable further mechanistic research into DNA pol IIIC inhibition to accelerate the development of novel new antibiotics that are systemically active against a range of Gram-positive pathogens resistant to currently available antibiotics. This new research also aims to generate the first-ever 3D structure of Pol C from methicillin-resistant Staphylococcus aureus (MRSA) in complex with an Acurx inhibitor to advance discovery of new compounds to treat this high-priority clinical pathogen as designated by the CDC and FDA.
- Also in July 2026, a presentation of scientific data by Dr. Kevin Garey and his laboratory team at the University of Houston College of Pharmacy demonstrated that following treatment in his "state-of-the-art" laboratory model with ibezapolstat, the beneficial microorganisms in the gut will have the opportunity to repopulate the microbiome in a beneficial way that prevents recurrence. In addition, IBZ and fidaxomicin were superior in biofilm experimental models with IBZ significantly more effective at killing C. difficile than vancomycin and fidaxomicin.
- In August 2026, the Company received FDA Conditional Acceptance and USPTO Trademark Allowance of its proprietary name (or brand name) for ibezapolstat, which is CIFBEZY. These initial milestones will form the basis for the commercial identity of ibezapolstat, as the Company prepares to advance toward a Phase 3 trial or trials and commercialization.
- In August 2026, the Company received approval from the Japan Patent Office and the Mexico Patent Office, respectively,for newly granted patents that protect Acurx's DNA Polymerase IIIC inhibitors including compositions‑of‑matter, methods of use, and pharmaceutical compositions, which further strengthen Acurx's intellectual property portfolio and represents the most recent addition to the Company's expanding series of granted patents in the U.S. and abroad. The Ibezapolstat patents currently run through June 2042, subject to extensions that may be available and more importantly the Company has 10 years of regulatory exclusivity from the date of FDA approval based on its designation as a QIDP Product and status as a New Molecular Entity. Additional country‑level patent applications remain under review.
- In September 2026, the Company announced its presentation of a Scientific Poster at the Premier International C. difficile Symposium (or ICDS) Demonstrating Superior In Vitro Kill Kinetics of Ibezapolstat vs. standards of care vancomycin and Fidaxomicin against C. difficile including vancomycin-Resistant Enterococcus. These findings demonstrate that Enterococcus creates a protective shield that actively impairs C. difficile killing using standard of care antibiotics regimens, but not seen with Ibezapolstat. In addition, IBZ maintained superior bactericidal activity, including further decreasing C. difficile toxin B expression while simultaneously eradicating vancomycin-resistant bacterial overgrowth.
- In October 2026, we announced the publication in the ASM (American Society for Microbiology) SPECTRUM journal confirming data on our DNA Pol IIIC inhibitor pipeline of antibiotics demonstrating a potential microbiome-sparing class effect. This was the first ever head-to-head comparison of gut microbiome changes associated with novel and our preclinical Pol IIIC inhibitors to linezolid in a thigh infection model. IBZ demonstrated good solubility and systemic exposure and reduced MRSA bacterial burden while preserving microbiome metabolic function in contrast to the marked disruption by linezolid.
- In October 2026, at the Scientific Conference of the Infectious Diseases Society of America's IDWeek (Washington D.C.), Acurx presented at the Pipeline and Innovation Theater. Our Executive Chairman Bob DeLuccia and Dr. Gino Girardi, Acurx Director of Clinical Research, presented an update on our progress and highlighted the open enrollment of our PATHFINDER trial at clinical research sites across the U.S and our previously announced FDA guidance from our July 2026 Type C Meeting.
Third Quarter 2026 Financial Results
Cash Position:
The Company ended the third quarter with cash totaling $9.7 million, compared to $7.6 million as of December 31, 2025. During the quarter, the Company raised a total of approximately $1.5 million of gross proceeds through our Equity Line of Credit.
R&D Expenses:
Research and development expenses for the three months ended September 30, 2026 were $1.1 million compared to $0.4 million for the three months ended September 30, 2025, an increase of $0.7 million. The increase was due primarily to an increase in consulting costs of $0.7 million as a result of costs associated with the new recurrent CDI trial program. For the nine months ended September 30, 2026, research & development expenses were $2.5 million compared to $1.6 million for the nine months ended September 30, 2025. The $0.9 million increase was due primarily to a $0.8 million increase in consulting fees and a $0.1 million increase in manufacturing costs, both of which are a result of costs associated with the new recurrent CDI trial program.
G&A Expenses:
General and administrative expenses for the three months ended September 30, 2026 were $1.5 million compared to $1.6 million for the three months ended September 30, 2025, a decrease of $0.1 million. The decrease was primarily due to a $0.1 million decrease in professional fees, a $0.1 million decrease in legal costs, offset by a $0.1 million increase in compensation related expenses. For the nine months ended September 30, 2026, general and administrative expenses were $4.1 million compared to $4.9 million for the nine months ended September 30, 2025, a decrease of $0.8 million. The decrease was due primarily to a $0.4 million decrease in professional fees, $0.3 million decrease in legal costs, and $0.1 million decrease in compensation related expenses.
Net Income/Loss:
The Company reported a net loss of $2.6 million or $0.49 per diluted share for the three months ended September 30, 2026 compared to a net loss of $2.0 million or $1.23 per diluted share for the three months ended September 30, 2025. For the nine months ended September 30, 2026, the Company reported a net loss of $6.5 million or $1.59 per diluted share, compared to $6.4 million or $5.01 per diluted share for the nine months ended September 30, 2025, all for the reasons previously mentioned.
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: | Thursday, November 12, 2026 |
Time: | 8:00 a.m. ET |
Toll free (U.S.): | 1-877-790-1503; Access ID: 13763499 |
International: | Click here for participant international Toll-Free access numbers |
About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate preparing for advancement into international Phase 3 clinical trials to treat patients with acute C. difficile Infection (CDI) and it is also conducting a ground-breaking clinical trial targeting the prevention of recurrent CDI (rCDI). If successful, ibezapolstat will change the treatment paradigm for CDI and rCDI by providing one therapy for the full spectrum of CDI and rCDI from first occurrence to multiply recurrent episodes.
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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in acute CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization.
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 serious and life-threatening 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), 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 (CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing. The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months and may lead to an approval pathway for rCDI if the currently enrolling rCDI trial is successful.
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.
To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com.
Forward-Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci
President & Chief Executive Officer
Tel: 917-533-1469
Email: [email protected]
ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM BALANCE SHEETS | ||||||
September 30, | December 31, | |||||
2026 | 2025 | |||||
(unaudited) | (Note 2) | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 9,654,532 | $ | 7,556,100 | ||
Other Receivable | 42,127 | 48,417 | ||||
Prepaid Expenses | 640,608 | 85,018 | ||||
TOTAL ASSETS | $ | 10,337,267 | $ | 7,689,535 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 2,993,238 | $ | 2,420,943 | ||
TOTAL CURRENT LIABILITIES | 2,993,238 | 2,420,943 | ||||
TOTAL LIABILITIES | 2,993,238 | 2,420,943 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Preferred Stock; $0.001 par value, 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2026 and December 31, 2025 | — | — | ||||
Common Stock; $0.001 par value, 250,000,000 shares authorized, 5,879,237 and 2,348,113 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively | 5,879 | 2,348 | ||||
Additional Paid-In Capital | 89,145,371 | 80,554,738 | ||||
Accumulated Deficit | (81,807,221) | (75,288,494) | ||||
TOTAL SHAREHOLDERS' EQUITY | 7,344,029 | 5,268,592 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 10,337,267 | $ | 7,689,535 | ||
ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM STATEMENTS OF OPERATIONS | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2026 | 2025 | 2026 | 2025 | ||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
OPERATING EXPENSES | |||||||||||||
Research and Development | $ | 1,116,515 | $ | 429,691 | $ | 2,529,520 | $ | 1,552,699 | |||||
General and Administrative | 1,515,224 | 1,599,010 | 4,125,437 | 4,922,168 | |||||||||
. | |||||||||||||
TOTAL OPERATING EXPENSES | 2,631,739 | 2,028,701 | 6,654,957 | 6,474,867 | |||||||||
OPERATING LOSS | (2,631,739) | (2,028,701) | (6,654,957) | (6,474,867) | |||||||||
OTHER INCOME | |||||||||||||
Interest Income | 48,167 | 35,911 | 136,230 | 86,605 | |||||||||
NET LOSS | $ | (2,583,572) | $ | (1,992,790) | $ | (6,518,727) | $ | (6,388,262) | |||||
LOSS PER SHARE | |||||||||||||
Basic and diluted net loss per common share | $ | (0.49) | $ | (1.23) | $ | (1.59) | $ | (5.01) | |||||
Weighted average common shares outstanding, basic and diluted | 5,315,469 | 1,625,805 | 4,107,327 | 1,275,592 | |||||||||
SOURCE Acurx Pharmaceuticals, Inc.
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