Acurx Pharmaceuticals, Inc. Reports Third Quarter 2026 results and provides business update
Cash increased from year-end, but shares outstanding also rose as Acurx advanced its recurrent-infection clinical program.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Acurx Pharmaceuticals (ACXP) reported a wider third-quarter 2026 net loss while beginning enrollment in its PATHFINDER trial of ibezapolstat. Net loss was $2,583,572, versus $1,992,790 a year earlier, while diluted loss per share narrowed to $0.49 from $1.23. Cash totaled $9,654,532 at September 30, versus $7,556,100 at December 31, 2025; quarterly equity-line financing raised approximately $1.5 million gross.
The fully funded, 20-patient PATHFINDER trial began enrollment September 29 for multiply recurrent C. difficile infection. FDA is open to discussing whether PATHFINDER and a single Phase 3 IBZ-ASPIRE trial provide sufficient evidence for a drug application after ASPIRE concludes. Acurx said successful PATHFINDER results could instead allow a pivotal recurrent-infection trial under FDA's limited-population antibiotic pathway. Acute-infection Phase 3 advancement remains subject to financing.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointApproximately $1.5 million gross raised through the equity line of credit during the quarter. 26% of market cap
- Moderate pointCash reached $9,654,532 at September 30, 2026, versus $7,556,100 at December 31, 2025.
- Moderate pointFully funded, 20-patient PATHFINDER trial began enrolling patients with multiply recurrent infection on September 29, 2026.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Potential alternative approval route: Acurx says successful PATHFINDER results may enable pivotal PATHFINDER II instead of ASPIRE.
- Moderate pointNine-month administrative expenses fell to $4,125,437 from $4,922,168 a year earlier.
10 minor points
- Minor pointQuarterly administrative expenses fell to $1,515,224 from $1,599,010 a year earlier.
- Minor pointQuarterly interest income increased to $48,167 from $35,911 a year earlier.
- Minor pointNine-month interest income increased to $136,230 from $86,605 a year earlier.
- Minor pointJapan and Mexico patents granted for DNA polymerase IIIC inhibitors; ibezapolstat patents currently run through June 2042.
- Minor point. Forward-looking: it has not happened yet and may not happen.10 years of regulatory exclusivity would run from FDA approval, based on QIDP and new-molecular-entity status.
- Minor pointCIFBEZY brand name received FDA conditional acceptance and USPTO trademark allowance in August 2026.
- Minor pointLeiden University Medical Center partnership continued through a July 2026 agreement to advance inhibitor research.
- Minor pointLaboratory biofilm results showed ibezapolstat more effective at killing C. difficile than vancomycin and fidaxomicin.
- Minor pointSeptember laboratory findings showed ibezapolstat reduced C. difficile toxin B expression and eradicated vancomycin-resistant bacterial overgrowth.
- Minor pointOctober preclinical publication reported reduced MRSA bacterial burden with preserved microbiome metabolic function, unlike linezolid.
Negative
- Major pointShares outstanding increased to 5,879,237 at September 30, 2026, from 2,348,113 at December 31, 2025, diluting holders.
- Moderate pointQuarterly net loss widened to $2,583,572 from $1,992,790; diluted loss per share narrowed to $0.49 from $1.23.
- Moderate pointQuarterly research spending increased to $1,116,515 from $429,691 a year earlier.
- Moderate pointDrug-application pathway remains conditional on sufficient PATHFINDER and ASPIRE efficacy evidence and further FDA discussion.
- Moderate pointAcute-infection Phase 3 advancement remains subject to obtaining appropriate financing.
3 minor points
- Minor pointNine-month net loss widened to $6,518,727 from $6,388,262; diluted loss per share narrowed to $1.59 from $5.01.
- Minor pointNine-month research spending increased to $2,529,520 from $1,552,699 a year earlier.
- Minor pointAccounts payable and accrued expenses increased to $2,993,238 from $2,420,943 at December 31, 2025.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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 theU.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
R&D Expenses:
Research and development expenses for the three months ended September 30, 2026 were
G&A Expenses:
General and administrative expenses for the three months ended September 30, 2026 were
Net Income/Loss:
The Company reported a net loss of
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:
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Date: |
Thursday, November 12, 2026 |
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Time: |
8:00 a.m. ET |
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Toll free ( |
1-877-790-1503; Access ID: 13763499 |
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International: |
Click here for participant international Toll-Free access numbers |
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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
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: davidluci@acurxpharma.com
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ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM BALANCE SHEETS |
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September 30, |
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December 31, |
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2026 |
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2025 |
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(unaudited) |
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(Note 2) |
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ASSETS |
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CURRENT ASSETS |
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Cash |
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$ |
9,654,532 |
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$ |
7,556,100 |
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Other Receivable |
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42,127 |
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48,417 |
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Prepaid Expenses |
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640,608 |
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85,018 |
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TOTAL ASSETS |
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$ |
10,337,267 |
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$ |
7,689,535 |
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LIABILITIES AND SHAREHOLDERS' EQUITY |
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CURRENT LIABILITIES |
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Accounts Payable and Accrued Expenses |
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$ |
2,993,238 |
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$ |
2,420,943 |
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TOTAL CURRENT LIABILITIES |
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2,993,238 |
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2,420,943 |
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TOTAL LIABILITIES |
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2,993,238 |
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2,420,943 |
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COMMITMENTS AND CONTINGENCIES |
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SHAREHOLDERS' EQUITY |
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Preferred Stock; shares issued and outstanding at September 30, 2026 and December 31, 2025 |
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— |
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— |
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Common Stock; 5,879,237 and 2,348,113 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively |
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5,879 |
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2,348 |
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Additional Paid-In Capital |
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89,145,371 |
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80,554,738 |
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Accumulated Deficit |
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(81,807,221) |
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(75,288,494) |
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TOTAL SHAREHOLDERS' EQUITY |
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7,344,029 |
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5,268,592 |
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
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$ |
10,337,267 |
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$ |
7,689,535 |
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ACURX PHARMACEUTICALS, INC. CONDENSED INTERIM STATEMENTS OF OPERATIONS |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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(unaudited) |
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(unaudited) |
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(unaudited) |
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(unaudited) |
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OPERATING EXPENSES |
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Research and Development |
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$ |
1,116,515 |
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$ |
429,691 |
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$ |
2,529,520 |
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$ |
1,552,699 |
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General and Administrative |
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1,515,224 |
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1,599,010 |
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4,125,437 |
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4,922,168 |
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. |
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TOTAL OPERATING EXPENSES |
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2,631,739 |
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2,028,701 |
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6,654,957 |
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6,474,867 |
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OPERATING LOSS |
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(2,631,739) |
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(2,028,701) |
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(6,654,957) |
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(6,474,867) |
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OTHER INCOME |
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Interest Income |
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48,167 |
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35,911 |
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136,230 |
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86,605 |
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NET LOSS |
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$ |
(2,583,572) |
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$ |
(1,992,790) |
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$ |
(6,518,727) |
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$ |
(6,388,262) |
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LOSS PER SHARE |
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Basic and diluted net loss per common share |
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$ |
(0.49) |
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$ |
(1.23) |
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$ |
(1.59) |
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$ |
(5.01) |
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Weighted average common shares outstanding, basic and diluted |
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5,315,469 |
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1,625,805 |
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4,107,327 |
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1,275,592 |
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View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-third-quarter-2026-results-and-provides-business-update-302929295.html
SOURCE Acurx Pharmaceuticals, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Acurx's third-quarter 2026 loss and cash balance?
Acurx reported a $2,583,572 net loss and $9,654,532 in cash at September 30, 2026. The year-earlier quarterly loss was $1,992,790. Diluted loss per share was $0.49, compared with $1.23 a year earlier.
What is Acurx's PATHFINDER trial testing?
PATHFINDER is a fully funded, 20-patient trial of ibezapolstat in multiply recurrent C. difficile infection, with enrollment beginning September 29, 2026. Acurx says successful results could support an alternative development route involving a pivotal PATHFINDER II trial in recurrent infection.
Which patients is Acurx enrolling in the PATHFINDER pilot trial?
The open-label pilot targets patients with multiply recurrent C. difficile infection who have experienced at least 3 episodes within the past 12 months. Open-label means treatment assignments are known rather than concealed.